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CMSManualSystemDepartmentofHealth&HumanServices(DHHS)Pub.
100-07StateOperationsProviderCertificationCentersforMedicare&MedicaidServices(CMS)Transmittal65Date:October1,2010SUBJECT:RevisionstoChapter2,"TheCertificationProcess,"Sections2080–2089-"Hospices,"andAppendixM,"GuidancetoSurveyors,Hospices"I.
SUMMARYOFCHANGES::Chapter2,Sections2080–2089hasbeenrevisedtoreflectchangesinpoliciesandproceduresrelatedtothenewregulationsat42CFR418.
52-116forhospiceproviders.
AppendixMisalsorevised.
NEW/REVISEDMATERIAL-EFFECTIVEDATE*:October1,2010IMPLEMENTATIONDATE:October1,2010Disclaimerformanualchangesonly:Therevisiondateandtransmittalnumberapplytothereditalicizedmaterialonly.
Anyothermaterialwaspreviouslypublishedandremainsunchanged.
However,ifthisrevisioncontainsatableofcontents,youwillreceivethenew/revisedinformationonly,andnottheentiretableofcontents.
II.
CHANGESINMANUALINSTRUCTIONS:(N/Aifmanualnotupdated.
)(R=REVISED,N=NEW,D=DELETED)–(OnlyOnePerRow.
)R/N/DCHAPTER/SECTION/SUBSECTION/TITLER2/TableofContentsR2/2080A/CitationsR2/2080B/DescriptionR2/2080C/HospiceCoreServicesN2/2080C.
1/WaiverofCertainStaffingRequirementsN2/2080C.
2/ContractingforHighlySpecializedServicesN2/2080C.
3/HospiceNursingShortageProvisionN2/2080D/HospiceRequiredServicesN2/2080D.
1/HospiceInterdisciplinaryGroup(IDG)R2/2081/RevokingElectionofHospiceCareR2/2082/DischargefromHospiceCareR2/2083/HospiceRegulationsandNon-MedicarePatientsR2/2084/HospiceInpatientServicesN2/2084.
1/HospiceProvidesInpatientCareDirectlyN2/2084.
2/HospiceProvidesInpatientServicesUnderArrangementsR2/2085/OperationofHospiceAcrossStateLinesR2/2086/HospiceChangeofAddressN2/2086.
1/EffectiveDateN2/2086.
2/AdministrativeReviewN2/2086.
3/MoveafterCertificationSurveyR2/2087/SimultaneousSurveysN2/2088/MultipleLocationsN2/2089/SurveyRequirementsWhentheHospiceProvidesCaretoResidentsofaSNF/NForICF/MRRAppendixM"GuidancetoSurveyors,Hospices"III.
Funding:NoadditionalfundingwillbeprovidedbyCMS;contractoractivitiesaretobecarriedoutwithintheirFY2010operatingbudgets.
IV.
ATTACHMENTS:BusinessRequirementsXManualInstructionConfidentialRequirementsOneTimeNotificationRecurringUpdateNotification*Unlessotherwisespecified,theeffectivedateisthedateofservice.
StateOperationsManualChapter2-TheCertificationProcessTableofContents(Rev.
65,10-01-10)2080C-HospiceCoreServices2080C.
1-WaiverofCertainStaffingRequirements2080C.
2-ContractingforHighlySpecializedServices2080C.
3-HospiceNursingShortageProvision2080D-HospiceRequiredServices2080D.
1-HospiceInterdisciplinaryGroup(IDG)2081-RevokingElectionofHospiceCare2082-DischargefromHospiceCare2084-HospiceInpatientServices2086-HospiceChangeofAddress2086A-EffectiveDate2086B-AdministrativeReview2086C-MoveAftercertificationSurvey2087-SimultaneousSurveys2088-MultipleLocations2089-SurveyRequirementsWhentheHospiceProvidesCaretoResidentsofaSNF/NForICF/MR2080A–Citations(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Section1861(u)oftheActestablisheshospicesasaproviderofservices.
Section1861(dd)oftheSocialSecurityAct(theAct)defineshospicecareandthehospiceprogram.
Section42CFR418setsforththeConditionsofParticipation(CoPs)thathospicesmustmeetandappliestoahospiceasanentityaswellastotheservicesprovidedtoeachindividualunderhospicecare.
Section42CFRPart418.
110isaconditionapplicableonlytohospicesthatprovideshort-terminpatientcareandrespitecaredirectly,ratherthanunderarrangementswithotherparticipatingproviders.
Section1866(a)(1)(Q)oftheActrequireshospices,amongotherproviders,tofileanagreementwiththeSecretarytocomplywiththerequirementsfoundin§Section1866(f)oftheActregardingadvancedirectives.
TheCentersforMedicare&MedicaidServices(CMS)hasaWebsiteforsurveyandcertificationinformationincludinghospicepolicymemos,theStateOperationsManual,§§2080-2089relatingtohospices,andAppendixM,"HospiceSurveyProceduresandInterpretiveGuidelines.
"Thisinformationisavailableathttp://www.
cms.
hhs.
gov/SurveyCertificationGenInfo/DefinitionAhospiceisapublicagencyorprivateorganizationorasubdivisionofeitherofthesethatisprimarilyengagedinprovidingcareandservicestoterminallyillindividuals,meetstheCoPsforhospices,andhasavalidMedicareprovideragreement.
ThelawgoverningtheprovisionofMedicarehospiceservicesisfoundatSection1861(dd)oftheAct.
Thelawfurtherclarifiesthat"terminallyillindividuals"areindividualshavinga"medicalprognosisthattheindividual'slifeexpectancyis6monthsorless.
"Thisdefinitionisfurtherclarifiedat42CFR418.
3toprovideforalifeexpectancyof6monthsorless"iftheillnessrunsitsnormalcourse.
"Althoughthelawdoesnotexplicitlydefineitsexpectationsfor"primarilyengaged,"CMShasinterpretedittomeanexactlywhatitsays,thatahospiceprovidermustbeprimarilyengagedinprovidinghospicecareandservices(Section1861(dd)(2)(A)(i)).
"Primarily"doesnotmean"exclusively.
"Thisrequirementdoesnotprecludethehospicefromprovidingservicestoterminallyillindividualswhohavenotelectedthehospicebenefitorprovidingservicestoindividualswhoarenotterminallyill,aslongastheprimaryactivityofthehospiceistheprovisionofhospiceservicestoterminallyillindividualsandthehospicemeetsallrequirementsforparticipationinMedicare.
HospiceBenefitPeriodsAnindividualmayelecttoreceiveMedicarehospicebenefitsfortwoperiodsof90daysandanunlimitedamountofperiodsfor60dayseach.
(See42CFR418.
21.
)EligibilityRequirementsInordertobeeligibletoelecthospicecareunderMedicare,anindividualmustbeentitledtoPartAofMedicareandbecertifiedasbeingterminallyill.
(SeeSection418.
20.
)Anindividualisconsideredtobeterminallyilliftheindividualhasamedicalprognosisthathisorherlifeexpectancyis6monthsorlessiftheillnessrunsitsnormalcourse.
Referralsmaycomefromanysource,butpatientsmustbeassessedbythehospicemedicaldirectorforappropriatenessofadmissioninconsultationwiththepatient'sattendingphysician(iftheindividualhasone).
Thehospicemedicaldirectormustconsiderthediagnosisoftheterminalconditionofthepatient,otherhealthconditions,whetherrelatedorunrelatedtotheterminalillness,andcurrentclinicallyrelevantinformationsupportingalldiagnoses.
Themedicaldirectormayconsultwiththeattendingphysiciandirectlyorthroughinformationobtainedindirectly.
Informationcouldbeobtainedthroughthehospicenurseorotherswhowouldbringtheattendingphysician'sknowledgeofthepatienttothemedicaldirectorwhentheadmissiondecisionisbeingmade.
Thehospicemustobtainwrittencertificationofterminalillnesswithin2calendardaysforeachofthebenefitperiodslistedinSection418.
21,evenifasingleelectioncontinuesineffectforanunlimitednumberofperiods.
Ifthehospicecannotobtainthewrittencertificationwithin2calendardays,afteraperiodbegins,itmustobtainoralcertificationwithin2calendardaysandwrittencertificationbeforeaclaimforpaymentissubmitted.
Fortheinitial90-dayperiod,certificationofterminalillnessmustbeobtainedfromthemedicaldirectorofthehospiceorthephysicianmemberofthehospiceinterdisciplinarygroup(IDG)andtheindividual'sattendingphysician(iftheindividualhasone).
RecertificationforsubsequentperiodsonlyrequiresthecertificationofthehospicemedicaldirectororthephysicianmemberoftheIDG.
Certificationstatementsmustbeonfileanddatedbythephysicianbeforethehospicesubmitsaclaimforpayment.
(SeeSection418.
22.
)2080B–Description(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)HospicecaremeansacomprehensivesetofservicesdescribedinSection1861(dd)(1)oftheAct,identifiedandcoordinatedbytheindividual'sattendingphysician,medicaldirectorandbyaninterdisciplinarygrouptoprovideforthephysical,psychosocial,spiritualandemotionalneedsofaterminallyillpatientandfamilymembers,asdelineatedinaspecificpatientplanofcare.
Hospiceusesaninterdisciplinaryapproachtocaringforterminallyillindividualsthatstressespalliativecareasopposedtocurativecare.
Palliativecaremeanspatientandfamily-centeredcarethatoptimizesqualityoflifebyanticipating,preventing,andtreatingsuffering.
Palliativecarethroughoutthecontinuumofillnessinvolvesaddressingphysical,intellectual,emotional,social,andspiritualneedsandfacilitatingpatientautonomy,accesstoinformation,andchoice.
Theemphasisofhospicecareisoneffectivesymptommanagement,withthegoalofmakingthepatientasphysicallyandemotionallycomfortableaspossible,andenablingthepatienttoremainathomeaslongaspossiblewithminimaldisruptiontonormalactivities.
Counselingandrespiteservicesareavailabletothefamilyofthehospicepatient.
Hospiceconsidersboththepatientandthefamilyastheunitofcare.
Althoughsomehospicesarelocatedaspartofahospital,skillednursingfacility(SNF),andhomehealthagency(HHA),hospicesmustmeetspecificCoPsandbeseparatelycertifiedandapprovedforMedicareparticipationasahospiceproviderofservices.
(SeeExhibit129for"HospiceSurveyandDeficienciesReport,"FormCMS-643,andExhibit72for"HospiceRequestforCertificationintheMedicareProgram,"FormCMS-417.
)2080C-HospiceCoreServices(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Withtheexceptionofphysicianservices,substantiallyallcoreservicesmustbeprovideddirectlybyhospiceemployeesonaroutinebasis.
Theseservicesmustbeprovidedinamannerconsistentwithacceptablestandardsofpractice.
Thefollowingarehospicecoreservices:Physicianservices;Nursingservices,(routinelyavailableand/oroncallona24-hourbasis,7daysaweek)providedbyorunderthesupervisionofaregisterednurse(RN)functioningwithinaplanofcaredevelopedbythehospice(IDG)inconsultationwiththepatient'sattendingphysician,ifthepatienthasone;Medicalsocialservicesbyaqualifiedsocialworkerunderthedirectionofaphysician;andCounseling(including,butnotlimitedto,bereavement,dietary,andspiritualcounseling)withrespecttocareoftheterminallyillindividualandadjustmenttodeath.
Thehospicemustmakebereavementservicesavailabletothefamilyandotherindividualsidentifiedinthebereavementplanofcareupto1yearfollowingthedeathofthepatient.
ThehospicemaycontractforphysicianservicesasspecifiedinSection418.
64(a).
Ahospicemayusecontractedstaff,ifnecessary,tosupplementhospiceemployeesinordertomeettheneedsofpatientsunderextraordinaryorothernon-routinecircumstances.
2080C.
1-WaiverofCertainStaffingRequirements(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Hospicesareprohibitedfromcontractingwithotherhospicesandnon-hospiceagenciesonaroutinebasisfortheprovisionofthecoreservicesofnursing,medicalsocialservicesandcounselingtohospicepatients.
Ahospicemay,however,enterintoarrangementswithanotherhospiceprogramorotherentityfortheprovisionofthesecoreservicesinextraordinary,exigent,orothernon-routinecircumstances.
Anextraordinarycircumstancegenerallywouldbeashort-termtemporaryeventthatwasunanticipated.
Examplesofsuchcircumstancesmightincludeunanticipatedperiodsofhighpatientloads,causedbyanunexpectedlylargenumberofpatientsrequiringcontinuouscaresimultaneously,temporarystaffingshortagesduetoillness,receivingpatientsevacuatedfromadisastersuchasahurricaneorawildfire,ortemporarytravelofapatientoutsidethehospice'sservicearea.
Thehospicethatcontractsforservicesmustmaintainprofessionalmanagementresponsibilityforallservicesprovidedunderarrangementorcontractatalltimesandinallsettings.
RegulationsatSection418.
100(e)discusstheprofessionalmanagementresponsibilitiesofthehospiceforservicesprovidedunderarrangement.
Hospicesmustmaintainevidenceoftheextraordinarycircumstancesthatrequiredthemtocontractforthecoreservicesandcomplywiththefollowing:Thehospicemustassurethatcontractedstaffisprovidingcarethatisconsistentwiththehospicephilosophyandthepatient'splanofcareandisactivelyparticipatinginthecoordinationofallaspectsofthepatient'shospicecare,andHospicesmaynotroutinelycontractforaspecificlevelofcare(e.
g.
,continuouscare)orduringspecifichoursofcare(e.
g.
,eveningsandweek-ends).
2080C.
2-ContractingforHighlySpecializedServices(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Ahospicemaycontractfortheservicesofaregisterednurseiftheservicesarehighlyspecialized,providednon-routinely,andsoinfrequentlythattheprovisionofsuchservicesdirectlywouldbeimpracticableandprohibitivelyexpensive.
Highlyspecializedservicesaredeterminedbythenatureoftheserviceandthenursingskilllevelrequiredtobeproficientintheservice.
Forexample,ahospicemayneedtocontractwithapediatricnurseifitcaresforpediatricpatientsinfrequently,andemployingapediatricnursewouldbeimpracticableandexpensive.
Continuouscareisnotahighlyspecializedservice,becausewhiletimeintensive,itdoesnotrequirehighlyspecializednursingskills.
2080C.
3–HospiceNursingShortageProvision(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)CMShasinstitutedatemporarymeasureforhospicesthatareunabletohireasufficientnumberofnursesdirectlyduetothenursingshortage.
DuringthetimeperiodfromOctober1,2008–September30,2010,inordertoqualifyforan"extraordinarycircumstance"exemption,ahospicemustnotifythestateagency(SA)responsibleforlicensingandcertificationthatitintendstoelectanexceptionunderthe"extraordinarycircumstance"authority.
ThismaybeaccomplishedbyprovidingwrittennotificationtotheSAwhenitbelievesthatthenursingshortagehasbecomean"extraordinarycircumstance"initsabilitytohirenursesdirectly,anditmustestimatethenumberofnursesitbelievesitwillcurrentlyneedtoemployundercontract.
NotificationmaybemadepriortoSeptember30,2010,andshouldaddressthefollowing:Anestimateofthenumberofpotentialpatientsthatthehospicehasnotbeenabletoadmitduringthepast--3monthsduetothenursingshortageandprovidethecurrentanddesiredpatient/nurseratiofortheagency;Evidencethatthehospicehasmadeagoodfaithefforttohireandretainnurses,including:-Copiesofrecentadvertisements(e.
g.
,inlocalnewspapers,Websites,etc.
,)thatdemonstraterecruitmentefforts;-Copiesofreportsoftelephonecontactswithpotentialhires,professionalschoolsandorganizations,recruitingservices,etc.
,and-Jobdescriptionsfornurseemployees;Evidencethatsalaryandbenefitsarecompetitiveforthearea;Evidenceofanyotherrecruitingactivities(e.
g.
,recruitingeffortsathealthfairs,educationalinstitutions,healthcarefacilities,andcontactswithnursesatotherprovidersinthearea);Ongoingself-analysesofthehospice'strendsinhiringandretainingqualifiedstaff;andEvidencethatthehospicehasatrainingprograminplacetoensurethatcontractedstaffaretrainedinthehospicephilosophy,andabletoprovidepalliativecarepriortopatientcontact;Contractednursesmayonlybeusedtosupplementthehospicenursesemployeddirectlyandshouldnotbeusedsolelytoprovidethecontinuousnursinglevelofcareoroncallservice.
Thehospiceisexpectedtocontinueitsrecruitmenteffortsduringtheperiodthatitiscontractingfornurses.
NoapprovalactionisrequiredontheSA'spartwhenitreceiveswrittennotificationfromahospiceforanexemption,aslongasthehospiceprovidestheappropriateinformation.
TheSAwillmaintaincopiesofeachexceptionnotificationandvalidatethehospice'sstatedneedforanexemptionduringcomplaintandre-certificationsurveys.
OfparticularimportancewillbetheextenttowhichthehospicenurseshavebeentrainedinthehospicephilosophyandareabletoeffectivelyprovidecaretothepatientsconsistentwiththepatientspecificplanofcareestablishedbytheIDG.
NOTE:CMShasinstitutedatemporarymeasuretoallowindividualhospicestocontractfornursesuntilSeptember30,2010,ifthehospicecandemonstratethatthenursingshortageiscreatinganextraordinarycircumstancethatpreventsitfromhiringanadequatenumberofnurses.
2080D-HospiceRequiredServices(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Requirementfor24-HourServicesThehospiceisrequiredbytheCoPsatSection418.
100tomakenursingservices,physicianservices,drugs,andbiologicalsroutinelyavailableona24-hourbasis,7daysaweek.
Italsohastomakeallothercoveredservicesavailableona24-hourbasis,7daysaweek,whenreasonableandnecessarytomeettheneedsofthepatientandfamily.
Inadditiontothehospicecoreservices(physicianservices,nursingservices,medicalsocialservices,andcounseling),thefollowingservicesmustbeprovidedbythehospice,eitherdirectlyorunderarrangements,tomeettheneedsofthepatientandfamily:Physicalandoccupationaltherapyandspeech-languagepathologyservices;HospiceaideservicesAhospiceaideemployedbyahospice,eitherdirectlyorundercontract,mustmeetthequalificationsrequiredbySection1891(a)(3)oftheActandimplementedatSection418.
76;Homemakerservices;Volunteers;Medicalsupplies(includingdrugsandbiologicalsona24-hourbasis)andtheuseofmedicalappliancesrelatedtotheterminaldiagnosisandrelatedconditions;Short-terminpatientcare(includingrespitecareandinterventionsnecessaryforpaincontrolandacuteandchronicsymptommanagement)inaMedicare/Medicaidparticipatingfacility;andContinuoushomecareprovidedduringaperiodofcrisis.
Nursingcaremaybecoveredonacontinuousbasisforasmuchas24hoursadayduringperiodsofcrisis,asnecessarytomaintainthepatientathome.
Section418.
204(a)definesacrisisastheperiodinwhichanindividualrequirescontinuouscareforasmuchas24hourstoachievepalliationormanagementofacutemedicalsymptoms.
Thecareprovidedmustrequireatleast8hoursofcareina24hourperiod,andthecaremustbeprovidedpredominantlybyalicensednurse(RN,LVN,LPN).
Homemakerorhospiceaideservicesorbothmayalsobecoveredifneeded.
Section1861(dd)(5)oftheActallowsCMStopermitcertainwaiversoftherequirementsthatthehospicemakephysicaltherapy,occupationaltherapy,speechlanguagepathologyservices,anddietarycounselingavailable(asneeded)ona24-hourbasis.
CMSisalsoallowedtowaivetherequirementthathospicesprovidedietarycounselingdirectly.
Thesewaiversareavailableonlytoanagencyororganizationthatislocatedinanareawhichisnotanurbanizedarea(asdefinedbytheBureauofCensus)andthatcandemonstratetoCMSthatithasbeenunable,despitediligentefforts,torecruitappropriatepersonnel.
ThesewaiversarecodifiedatSection418.
74.
2080D.
1-HospiceInterdisciplinaryGroup(IDG)(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)HospicesparticipatingintheMedicareprogrammustuseaninterdisciplinaryapproachtoassessingandmeetingthephysical,medical,psychosocial,emotional,andspiritualneedsofthehospicepatientsandfamiliesfacingterminalillnessandbereavement.
ThehospiceIDGmembersinclude,butarenotlimitedto,thehospicephysician(doctorofmedicineorosteopathy)whomustbeanemployeeoforundercontractwiththehospice,registerednurse,socialworker,andpastoralorothercounselor.
TheIDGisrequiredtoconductacomprehensiveassessmentofthepatientandupdatetheassessmentatrequiredtimepoints.
Inaddition,thegroup,inconsultationwiththepatient'sattendingphysician,ifthepatienthasone,mustprepareawrittenplanofcareforeachpatientthatreflectspatientandfamilygoalsandinterventionsbasedontheneedsidentifiedintheinitial,comprehensive,andupdatedassessments.
Theplanofcaremustincludeallservicesnecessaryforthepalliationandmanagementoftheterminalillnessandrelatedconditions.
Theattendingphysicianmayeitherbeadoctorofmedicineorosteopathyoranursepractitioner.
Thispersonisidentifiedbytheindividual,atthetimeheorsheelectstoreceivehospicecare,ashavingthemostsignificantroleinthedeterminationanddeliveryoftheindividual'smedicalcare.
Intheeventthatabeneficiary'sattendingphysicianisanursepractitioner,thehospicemedicaldirectorand/orphysiciandesigneemustcertifyorre-certifytheterminalillness.
Nursepractitionerscannotcertifyaterminaldiagnosisortheprognosisof6monthsorless,iftheillnessordiseaserunsitsnormalcourse,orre-certifyaterminaldiagnosisorprognosis.
ThehospiceIDGisresponsiblefordevelopingandmaintainingasystemofcommunication,coordination,andintegrationofservicesthatensuresthattheplanofcareisreviewedandupdatednolessfrequentlythanevery15calendardays.
Itisnotpermissibleforeithertheattendingphysicianorthehospicemedicaldirectortoprovidethesoleguidancefortheplanofcare.
ThelawandregulationsrequirethatitbethecombinedworkoftheIDG.
2081–RevokingElectionofHospiceCare(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Thehospicepatientorrepresentativemayrevokethepatient'selectionofhospicecareatanytimeduringtheelectionperiodaccordingtoSection418.
28.
Revocationisavoluntaryactiontakenbythepatientorrepresentative.
Theelectionofthehospicebenefitisthebeneficiary'schoiceratherthanthehospice'schoice,andthehospicecannotrevokethebeneficiary'selection.
Itisimportantforthehospicetoeducatethepatientandfamilybeforethestartofcarethathospiceentailscertainlimitsinthewaycarewillbeprovided,includingrestrictionsonobtainingcareoutsidethecarearrangedfororprovidedbythehospice,andthepatient'sliabilityforcarereceivedwithoutthehospice'sinvolvement.
Thehospiceshouldneitherrequestnorpressurethepatient/familyorrepresentativeinanywaytorevokehis/herelection.
2082–DischargefromHospiceCare(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)OnceahospicechoosestoadmitaMedicarebeneficiary,itmaynotautomaticallyorroutinelydischargethebeneficiaryatitsdiscretion,evenifthecarepromisestobecostly,inconvenient,ortheStateallowsfordischargeunderStatelaw.
Thesituationsunderwhichahospicemaydischargeapatientareaddressedintheregulationat418.
26andincludethefollowingsituations:Thepatientmovesoutofthehospice'sserviceareaortransferstoanotherhospice;Thehospicedeterminesthatthepatientisnolongerterminallyill;andThehospicedeterminesunderapolicysetbythehospiceforthepurposeofaddressingdischargeforcause,thatthepatient's(orotherpersonsinthepatient'shome)behaviorisdisruptive,abusive,oruncooperativetotheextentthatdeliveryofcaretothepatientortheabilityofthehospicetooperateeffectivelyisseriouslyimpaired.
Thehospicemustdothefollowingbeforeitseekstodischargeapatientforcause:Advisethepatientthatadischargeforcauseisbeingconsidered;Makeaseriousefforttoresolvetheproblem(s)presentedbythepatient's(orotherpersonsinthepatient'shome)behaviororsituation;Ascertainthatthepatient'sproposeddischargeisnotduetothepatient'suseofnecessaryhospiceservices;andDocumentintheclinicalrecord,theproblem(s)andeffortsmadetoresolvetheproblem(s).
Priortodischargingapatientforanyreasonstatedabove,thehospiceIDGmustobtainawrittenphysician'sdischargeorderfromthehospicemedicaldirector.
Ifapatienthasanattendingphysicianinvolvedinhisorhercare,thisphysicianshouldbeconsultedbeforedischargeandhis/herreviewanddecisionincludedinthedischargenote.
ThehospicenotifiesitsMedicareadministrativecontractor(MAC)andSAofthecircumstancessurroundingtheimpendingdischarge.
Thehospiceshouldalsoconsiderreferralstootherappropriateand/orrelevantstate/communityagencies(i.
e.
,AdultProtectiveServices)orhealthcarefacilitiesbeforedischarge.
2083-HospiceRegulationsandNon-MedicarePatients(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)ThehospiceCoPsapplytoallpatientsofthehospice(Medicareandnon-Medicare),withtheexceptionofthefollowingregulations,whichapplyonlytoMedicarebeneficiaries:Section418.
100(d)-thecontinuationofcarerequirement,andSection418.
108(d)-the80-20inpatientcarelimitation.
Inaddition,thefollowingCoPsregardingthecertificationandrecertificationofterminalillnessarenecessarytodetermineeligibilityforMedicareandMedicaidpatientsandmayormaynotbearequirementbyotherpaymentsources:Section418.
102(c);Section418.
104(a)(5);andSection418.
112(e)(3)(iii).
2084-HospiceInpatientServices(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Hospicesmustmakeinpatientcareavailableforpaincontrol,symptommanagement,andrespitepurposes.
Thisinpatientcaremaybeprovideddirectlybythehospiceorindirectlyunderarrangementsmadebythehospice.
Ifservicesareprovidedunderarrangements,thehospicemustensurethattheservicesareinfullcompliancewithallapplicablestandardsrelatingtoinpatientcarefoundatSection418.
110andSection418.
108.
2084A-HospiceProvidesInpatientCareDirectly(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Whenthehospiceprovidesinpatientcaredirectly,itmaydosoeitherinspacethatitownsorleasesorinspacesharedwithaMedicarecertifiedhospital,SNF,orMedicaidcertifiednursingfacility(NF).
Ifthehospiceprovidescareinitsowninpatientfacility,thecaremaybeprovidedinspacethatthehospiceeitherownsorleasesfromanotherfacilityorbuilding.
Theinpatientunitmayconsistofseveralbeds,agroupofbeds,orawingandmustmeetallapplicableFederalandStaterequirementsandbesurveyedforcompliancewithSection418.
110priortoprovidinginpatientcaretopatients.
ThissurveyincludesaLifeSafetyCodesurvey(whichhascurrentlyadoptedthe2000editionoftheLifeSafetyCodeoftheNationalFireProtectionAssociation)thatmustbedonebothatthetimeofinitialcertificationoftheinpatientfacilityandatthetimeofrecertificationsurveys.
IfthehospiceprovidescaredirectlywithhospicestaffinspacesharedwithaMedicare-certifiedHospital,SNF,oraMedicaidcertifiedNF(forrespitecareonly),theSAreviewstheagreementandpatientfilesforcompliancewithSection418.
110(b)andSection418.
110(e)sincethelocationalreadymeetstheremainingrequirementsofSection418.
110asaMedicare/Medicaidparticipatingfacility.
2084B-HospiceProvidesInpatientServicesUnderArrangements(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)WhenthehospiceprovidesinpatientservicesunderarrangementswithaMedicareparticipatinghospitalorSNF,aMedicaidparticipatingNF(forrespitecareonly),oraninpatientunitofanotherMedicare-certifiedhospice,aseparatesurveyofeachsiteisnotrequired.
Inthesecases,theSAreviewstheagreementandpatientfilestoassurethatthestandardsinSection418.
110(b)regarding24-hournursingserviceandSection418.
110(e)regardingcomfortandprivacyofpatientandfamilymembersaresatisfied.
However,ifinreviewingcontractsandotherdocumentation(e.
g.
,clinicalrecords,plansofcare),questionsariseconcerningthecontractarrangements,theSAconductsanonsitevisittotheinstitutionprovidingtheinpatientservicestoreviewthecareprovidedunderarrangements,nottoinspectthefacility.
ThisincludeshospitalsthatareaccreditedbyTheJointCommissionortheAmericanOsteopathicAssociationthatareprovidinginpatientservicesunderarrangements.
ApplicabilityofInpatientCareCoPSection418.
110LocationWhereInpatientCareisProvidedApplicabilityofConditionHospicefreestandinginpatientfacilitySurveyforcompliancewithSection418.
100.
MedicarecertifiedhospitalorSNFand/orMedicaidcertifiedNF(forrespitecareonly.
)SurveyforcompliancewithSection418.
110(b)andSection418.
110(e).
TheinstitutionalreadymeetstheremainingrequirementsofSection418.
110asaMedicare/MedicaidcertifiedhospitalorSNF/NF.
AhospicefreestandinginpatientfacilityisdefinedinthiscontextasafacilitythatisnotapartofanotherMedicare/Medicaidcertifiedfacility(e.
g.
,hospitalorSNF/NF).
2085-OperationofHospiceAcrossStateLines(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)WhenahospiceprovidesservicesacrossStatelineseachrespectiveStateAgency(SA)mustbeawareofandapprovetheaction.
EachSAmustverifythatapplicablestatelicensure,personnellicensure,andotherStaterequirementsaremetinitsrespectiveState.
TheprovisionofservicesacrossStatelinesisappropriateinmostcircumstances.
Areasinwhichcommunityservices,suchashospitals,publictransportation,andpersonnelservicesaresharedonbothsidesofStateboundariesaremostlikelytogenerateanextensionofhospiceservices.
WhenahospiceprovidesservicesacrossStatelines,itmustbecertifiedbytheStateinwhichitsCMScertificationnumber(CCN)isbased,anditspersonnelmustbequalifiedinallStatesinwhichtheyprovideservices.
TheappropriateSAcompletesthecertificationactivities.
TheinvolvedStatesmusthaveawrittenreciprocalagreementpermittingthehospicetoprovideservicesinthismanner.
ThereciprocalagreementmustindicatethatbothStatesareawareoftheirrespectiveresponsibilitiesforassessingthehospice'scompliancewiththeCoPwithintheirState.
Theagreementshouldassurethathomevisitsareconductedtoasampleofallpatients,inallStatesservedbythehospice.
TheCMSRegionalOffice(RO)willreviewtherequiredreciprocalagreementbetweentheStatestoassurethattheSAwherethepracticelocationresidesisassumingresponsibilityforanynecessarysurveysofthelocation.
IftheSAsareunabletocometoareciprocalagreementonassuringthenecessarysurveysofthelocation,thelocationshouldnotbeapprovedasapartofthehospice.
TheprovisionofinterstateservicewithoutawrittenreciprocalagreementcouldseverelyunderminetheState'sabilitytofulfillitsstatutoryresponsibilitiesunderSection1864oftheActtoenforceMedicare'shealthandsafetyrequirements.
ItisatthediscretionoftheStatestodecidewhetherenteringintoreciprocalagreementsisinthebestinterestoftheirresidents,providermarkets,andqualityassuranceandoversightsystems.
Exhibit289"ModelReciprocalAgreementSurveyandCertification"containsamodelreciprocalagreementdocumentforStatestousetoassisttheminfulfillingtheirstatutoryresponsibilitytoenforceMedicare'shealthandsafetyrequirementswhenahospiceprovidesservicesacrossStatelines.
InStatesthathaveareciprocalagreementinplace,providersarenotrequiredtobeseparatelyapprovedineachState;consequently,theywouldnothavetoobtainaseparateMedicareprovideragreement/certificationnumberineachState.
ProvidersresidinginaStatethatdoesnothaveareciprocalagreementwithacontiguousStateareprecludedfromprovidingservicesacrossStatelines.
IntheeventthatthehospiceoperatesintwoCMSROs,theROresponsiblefortheStateinwhichthehospiceprovideragreement/certificationnumberisbasedshouldtaketheleadinassuringthattherequiredsurveyandcertificationactivitiesaremet.
2086–HospiceChangeofAddress(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)ItisinherentintheprovidercertificationprocessthataprovidernotifyCMSofitsintenttochangethelocationorsitefromwhichitprovidesservices.
Absentsuchnotification,CMShasnowayofcarryingoutitsstatutorilymandatedobligationofdeterminingwhethertheprovideriscomplyingwithapplicableparticipationrequirementsatthenewsiteorlocation.
ItisalongstandingCMSpolicythatthereisnobasisforaprovidertobillMedicareforservicesprovidedfromasiteorlocationthathasnotbeendeterminedtomeetapplicablerequirementsofparticipation.
ThisguidanceiscontainedinSection3224(ofwhat--whereisthiscontained).
Whenanexistinghospiceintendstomovefromitssurveyed,certifiedlocationtoanewsiteorlocation,itnotifiesCMSeitherdirectlyorthroughtheSA,and,ifdeemed,itnotifiesitsapprovednationalaccreditationorganization(AO),inwritingoftheproposedchangeoflocation.
TheprovideralsonotifiesitsMACandsubmitsallrequireddocumentationincludinganamendedFormCMS-855AbeforeCMSapprovalcanbegranted.
TheproviderobtainsCMS'approvalofthenewaddressbeforeitprovidesMedicareservicesfromthenewaddress.
Uponreceiptofaprovider'snoticeandrequestforapprovalofthemovetothenewsiteorlocation,theROwillcarefullyevaluatetheinformation,togetherwithanysupportingdocumentationfromtheproviderandanyotherrelevantinformationknowntotheROinmakingitsdecision.
Ifadecisioncanbemadeonthewrittenapplicationandsupportingdocumentation,CMSwillgrantordenyanapprovalwithoutrequiringasurvey.
If,however,theROconcludesthatcircumstanceswarrantasurveytoestablishwhetherthenewaddresscomplieswithallapplicablerequirements,CMSwilladvisetheproviderandwillmakenofurtherfindingsuntilasurveyhasbeencompletedandsubmittedtoCMSforitsreview.
Ineitherevent,CMSwillnotifytheproviderofitsdecisioninwriting,asappropriate.
CMSgenerallywillnotapproveachangeoflocationofaprimaryhospicewithoneormorepreviouslyapprovedmultiplelocationsifthenewlocationincreasesthedistancebetweentheprimaryhospicelocationanditspreviouslyapprovedmultiplelocation(s)toapointthatpreventsthehospicefromexertingthesupervisionandcontrolnecessaryateachmultiplelocationtoassurethatallhospicecareandservicescontinuetoberesponsivetotheneedsofthepatient/familyatalltimesandinallsettings.
Inthatevent,theapplicationforapprovalofthenewlocationwouldusuallybedeniedwithoutasurvey,andtheproviderwouldapplyforanewcertificationnumberforthenewlocation.
Requestforapprovalofaproposedchangeoflocationofanapprovedmultiplelocationishandledasarequestforapprovalofanewmultiplelocation,inaccordancewiththeregulationsandguidelinesatSection418.
100(f).
NOTE:CMSwillnotapproveachangeoflocationforahospice'sowninpatientfacilitywithoutasurveytoassurethatthefacilitymeetsallrequirementsspecifiedatSection418.
110.
2086A-EffectiveDate(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)AhospicemaynotbillforservicesprovidedfromthenewsiteorlocationandshouldnotbillMedicareuntilthenewsiteorlocationhasbeenapprovedbyCMS.
TheeffectivedateofcoverageforservicesprovidedfromthenewlocationisthedateCMSgrantsapprovaltothehospice'srequesttochangelocations.
ThefactthatanationalAOhasapprovedanewsiteorlocationwillnotaffectCMS'decision.
CMS'determinationwillbebasedonitsindependentapplicationofitsregulationstothefactsinthecase.
ServicesprovidedbeforetheeffectivedateofapprovalshouldnotbebilledtoMedicare.
2086B–AdministrativeReview(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)CMS'sdecisiononarequestforapprovalofachangeofaddressdoesnotqualifyasaninitialdeterminationsubjecttoadministrativereviewunderSection498.
3.
Suchadeterminationdoesnotaffecttheexistingprovideragreement,whichcontinuesineffectatthesurveyed,certifiedlocationuntilvoluntarilyterminatedbytheproviderpursuanttoSection489.
52orinvoluntarilyterminatedbyCMSpursuanttoSection489.
53.
Intheeventapprovalofthenewchangeofaddressisdenied,theproviderhastheoptionofformallyapplyingforinitialcertificationofthenewsiteorlocationasaseparateMedicareproviderofhospiceservices.
Inthatevent,aninitialcertificationsurveybyCMSortheSA(oraccreditationbasedonsurveybyanationalAOwithdeemingauthority)wouldberequired.
2086C–MoveafterCertificationSurvey(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Requestsforinitialcertificationcannotbeprocessedtocompletionifaprospectiveprovidermovestoanewlocationafteritissurveyedand/ordeemedtomeettheCoPsbyanationalAOwithdeemingauthority.
Ifaprospectiveprovidermovesafteritslocationhasbeensurveyedand/oraccreditedbutpriortoacertificationdeterminationbyCMS,theprospectiveprovider'sapplicationforcertificationbecomesincomplete.
Absentasurveyofthenewlocationtowhichtheprospectiveproviderhasmoved,CMSisunabletodeterminewhetherapplicableprogramrequirementsaremetatthenewlocation,andthereforeispreventedfromcompletingitsreviewofthependingapplication.
Inthesecircumstances,CMSadvisestheprospectiveproviderthatitsapplicationisincomplete.
SuchanincompleteapplicationisheldinabeyancependingreceiptofareportofsurveyofthecurrentlocationfromtheSAoranationalAOwithdeemingauthoritymeetingtherequirementsofandapprovedbyCMS.
ThedecisiontoholdanincompleteapplicationinabeyancedoesnotqualifyasaninitialdeterminationasdefinedinSection498.
3.
2087–SimultaneousSurveys(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)IfahospiceisestablishedbyanentitywhichparticipatesintheMedicareprogramasanothertypeofprovider(hospital,SNF,HHA),theSAshouldattempttocoordinatesimultaneouscertificationsurveysoftheseentities,i.
e.
,forcompliancewithhospiceCoPsandforcompliancewiththeotherappropriateCoPs/requirements.
NOTE:Section1861(dd)(4)(A)oftheActstatesthatifahospiceisapprovedasbeingpartofanothertypeofprovider,withaseparatecertificationnumber,itshallbeconsideredtomeetthoseCoPsthatarecommontoboththehospiceandtheothertypeofprovider.
2088–MultipleLocations(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Whenanexistinghospiceintendstoaddamultiplelocation,itmustnotifyCMS,theSA,and,ifdeemed,itshouldnotifyits'approvednationalAO,inwriting,oftheproposedlocationifitexpectsthislocationtoparticipateinMedicareorMedicaid.
ThehospicemustalsosubmitaFormCMS-855AChangeofInformationRequest(includingallsupportingdocumentation)toitsMACbeforeCMSapprovalcanbegranted.
TheprovidermustobtainCMSapprovalofthenewlocationbeforeitispermittedtobillMedicareforservicesprovidedfromthenewlocation.
Uponreceiptofahospice'snoticeandrequestforapprovalofamultiplelocation,theCMSROwillcarefullyevaluatetheinformation,togetherwithanysupportingdocumentationfromthehospiceandanyotherrelevantinformationknowntotheROinmakingitsdecision.
Ifadecisioncanbemadebasedonthewrittenapplicationandsupportingdocumentation,CMSwillgrantordenyanapprovalwithoutrequiringasurvey.
If,however,theROconcludesthatcircumstanceswarrantasurveytoestablishwhetherthenewlocationcomplieswithallapplicablerequirements,CMSwilladvisetheproviderandwillmakenofurtherfindingsuntilaMedicarecertificationsurveyhasbeencompletedandsubmittedtoCMSforitsreview.
Ineitherevent,CMSwillnotifytheproviderofitsdecisioninwriting,asappropriate.
Inevaluatingahospice'srequestforapprovalofamultiplelocation,theSAandROshouldconsiderthefollowingindeterminingwhetherthenewlocationmeetsallapplicableMedicarerequirements:Abilityofthegoverningbodytomanagethelocation;Anychangesmadetothelinesofauthority,andprofessionalandadministrativecontrol;AbilityoftheMedicalDirectortoassumeresponsibilityforthemedicalcomponentofthehospice'spatientcareatalllocations;Abilityofthehospicetomonitorandexercisecontroloverservicesprovidedbypersonnelunderarrangementsorcontractsatthemultiplelocation;ChangesintheIDG(s)providinghospiceservices;Changesinstaffingortheclientpopulation,orboth;Changesinthewayclinicalrecordsaremaintained,protectedandsafeguardedagainstloss,destructionorunauthorizeduse;andAbilityofthehospicetoprovideallhospiceservicesatthemultiplelocation.
AhospicemaynotbillMedicareforservicesprovidedfromamultiplelocationuntilthenewsiteorlocationhasbeenapprovedbyCMS.
ThefactthatanationalAOwithdeemingauthorityhasapprovedanewsiteorlocationwillnotaffectCMS'decision.
CMS'determinationwillbebasedonitsindependentapplicationofitsregulationstothefactsinthecase.
ServicesprovidedbeforetheeffectivedateofapprovalshouldnotbebilledtoMedicare.
Ifthehospicedoesoperateatmultiplelocations,adeficiencyfoundatanylocationwillresultinacomplianceissuefortheentirehospice.
Forfurtherinformationonhospicemultiplelocations,see42CFR418.
100(f)and418.
116.
2089–SurveyRequirementsWhentheHospiceProvidesCaretoResidentsofaSNF/NForICF/MR(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)WhenaSNForNFisthehospicepatient'sresidenceforpurposesofthehospicebenefit,theSNForNFmustcomplywiththerequirementsforparticipationinMedicareorMedicaid.
TheMedicare/MedicaidregulationsforlongtermcarefacilitiesregardingthecompletionandsubmissionoftheResidentAssessmentInstrument/MinimumDataSet(RAI/MDS)datadonotchangewhentheresidentelectstheMedicareHospiceBenefit.
ThismeanstheSNForNFmustassessthehospiceresidentusingtheRAI,andhaveacareplanandprovidetheservicesrequiredundertheplanofcare.
Thiscanbeachievedthroughcooperationbetweenthehospiceandfacilitystaffwiththeconsentoftheresident.
Inthesesituations,thehospiceIDGshouldparticipatewiththefacilityincompletingtheRAI.
Similarly,theSNF/NFmustcompletetheRAIforanyhospicepatientwhoreceivesshortterminpatientcareinaMedicare/MedicaidparticipatingSNF/NFifthehospicepatientresidesinthefacilityformorethan14days.
Forfurtherinformationonthehospicerequirementswhenitprovidescareinthesesettings,see42CFRPart418.
112.
StateOperationsManualAppendixM-GuidancetoSurveyors:Hospice(Rev.
65,10-01-10)TransmittalsforAppendixMPartI–InvestigativeProceduresI-IntroductionC-PostSurveyRevisitPartII–InterpretiveGuidelinesSubpartC-ConditionsofParticipation:PatientCare§418.
3Definitions§418.
52ConditionofParticipation:Patient'sRights§418.
52(a)Standard:NoticeofRightsandResponsibilities§418.
52(b)Standard:ExerciseofRightsandRespectforPropertyandPerson§418.
52(c)Standard:RightsofthePatient§418.
54ConditionofParticipation:InitialandComprehensiveAssessmentofthePatient§418.
54(a)Standard:InitialAssessment§418.
54(b)Standard:TimeFrameforCompletionoftheComprehensiveAssessment§418.
54(c)Standard:ContentoftheComprehensiveAssessment§418.
54(d)Standard:UpdateoftheComprehensiveAssessment§418.
54(e)Standard:PatientOutcomeMeasures§418.
56ConditionofParticipation:InterdisciplinaryGroup,CarePlanning,andCoordinationofServices§418.
56(a)Standard:ApproachtoServiceDelivery§418.
56(b)Standard:PlanofCare§418.
56(c)Standard:ContentofthePlanofCare§418.
56(d)Standard:ReviewofthePlanofCare§418.
56(e)Standard:CoordinationofServices§418.
58ConditionofParticipation:QualityAssessmentandPerformanceImprovement§418.
58(a)Standard:ProgramScope§418.
58(b)Standard:ProgramData§418.
58(c)Standard:ProgramActivities§418.
58(d)Standard:PerformanceImprovementProjects§418.
58(e)Standard:ExecutiveResponsibilities§418.
60ConditionofParticipation:InfectionControl§418.
60(a)Standard:Prevention§418.
60(b)Standard:Control§418.
60(c)Standard:Education§418.
62ConditionofParticipation:LicensedProfessionalServices§418.
64ConditionofParticipation:CoreServices§418.
64(a)Standard:PhysicianServices§418.
64(b)Standard:NursingServices§418.
64(c)Standard:MedicalSocialServices§418.
64(d)Standard:CounselingServices§418.
66ConditionofParticipation:NursingServicesWaiverOfRequirementThatSubstantiallyAllNursingServicesBeRoutinelyProvidedDirectlybyaHospice§418.
70ConditionofParticipation:FurnishingofNon-coreServices§418.
72ConditionofParticipation:PhysicalTherapy(PT),OccupationalTherapy(OT),andSpeech-LanguagePathology(SLP)§418.
74WaiverofRequirement-PhysicalTherapy,OccupationalTherapy,Speech-languagePathologyandDietaryCounseling§418.
76ConditionofParticipation:HospiceAideandHomemakerServices§418.
76(a)Standard:HospiceAideQualifications§418.
76(b)Standard:ContentandDurationofHospiceAideClassroomandSupervisedPracticalTraining§418.
76(c)Standard:CompetencyEvaluation§418.
76(d)Standard:In-serviceTraining§418.
76(e)Standard:QualificationsforInstructorsConductingClassroomAndSupervisedPracticalTraining§418.
76(f)Standard:EligibleCompetencyEvaluationOrganizations§418.
76(g)Standard:HospiceAideAssignmentsandDuties§418.
76(h)Standard:SupervisionofHospiceAides§418.
76(i)Standard:IndividualsFurnishingMedicaidPersonalCareAide-OnlyServicesunderaMedicaidPersonalCareBenefit§418.
76(j)Standard:HomemakerQualifications§418.
76(k)Standard:HomemakerSupervisionandDuties§418.
78Conditionofparticipation:Volunteers§418.
78(a)Standard:Training§418.
78(b)Standard:Role§418.
78(c)Standard:RecruitingandRetaining§418.
78(d)Standard:CostSaving§418.
78(e)Standard:LevelofActivitySubpartD--ConditionsofParticipation:OrganizationalEnvironment§418.
100ConditionofParticipation:OrganizationandAdministrationofServices§418.
100(a)Standard:ServingtheHospicePatientandFamily§418.
100(b)Standard:GoverningBodyandAdministrator§418.
100(c)Standard:Services§418.
100(d)Standard:ContinuationofCare§418.
100(e)Standard:ProfessionalManagementResponsibility§418.
100(f)Standard:HospiceMultipleLocations§418.
100(g)Standard:Training§418.
102ConditionofParticipation:MedicalDirector.
§418.
102(a)Standard:MedicalDirectorContract§418.
102(b)Standard:InitialCertificationofTerminalIllness§418.
102(c)Standard:RecertificationoftheTerminalIllness§418.
102(d)Standard:MedicalDirectorResponsibility§418.
104Conditionofparticipation:ClinicalRecords§418.
104(a)Standard:Content§418.
104(b)Standard:Authentication§418.
104(c)Standard:ProtectionofInformation§418.
104(d)Standard:RetentionofRecords§418.
104(e)Standard:DischargeorTransferofCare§418.
104(f)Standard:RetrievalofClinicalRecords§418.
106ConditionofParticipation:DrugsandBiologicals,MedicalSupplies,andDurableMedicalEquipment§418.
106(a)Standard:ManagingDrugsandBiologicals§418.
106(b)Standard:OrderingofDrugs§418.
106(c)Standard:DispensingofDrugsandBiologicals§418.
106(d)Standard:AdministrationofDrugsandBiologicals§418.
106(e)Standard:Labeling,Disposing,andStoringofDrugsandBiologicals§418.
106(f)Standard:UseandMaintenanceofEquipmentandSupplies§418.
108ConditionofParticipation:Short-termInpatientCare§418.
108(a)Standard:InpatientCareforSymptomManagementandPainControl§418.
108(b)Standard:InpatientCareforRespitePurposes§418.
108(c)Standard:InpatientCareProvidedunderArrangements§418.
108(d)Standard:InpatientCareLimitation§418.
108(e)Standard:ExemptionfromLimitation.
§418.
110ConditionofParticipation:HospicesthatProvideInpatientCareDirectly§418.
110(a)Standard:Staffing§418.
110(b)Standard:Twenty-fourHourNursingServices§418.
110(c)Standard:PhysicalEnvironment§418.
110(d)Standard:FireProtection§418.
110(e)Standard:PatientAreas§418.
110(f)Standard:PatientRooms§418.
110(g)Standard:Toilet/BathingFacilities§418.
110(h)Standard:PlumbingFacilities§418.
110(i)Standard:InfectionControl§418.
110(j)Standard:SanitaryEnvironment§418.
110(k)Standard:Linen§418.
110(l)Standard:MealServiceandMenuPlanning§418.
110(m)Standard:RestraintorSeclusion§418.
110(n)Standard:RestraintorSeclusionStaffTrainingRequirements§418.
110(o)Standard:DeathReportingRequirements§418.
112ConditionofParticipation:HospicesthatProvideHospiceCaretoResidentsofaSNF/NForICF/MR§418.
112(a)Standard:ResidentEligibility,Election,andDurationofBenefits§418.
112(b)Standard:ProfessionalManagement§418.
112(c)Standard:WrittenAgreement§418.
112(d)Standard:HospicePlanofCare§418.
112(e)Standard:CoordinationofServices§418.
112(f)Standard:OrientationandTrainingofStaff§418.
114ConditionofParticipation:PersonnelQualifications§418.
114(a)Standard:GeneralQualificationRequirements§418.
114(b)Standard:PersonnelQualificationsforCertainDisciplines§418.
114(c)Standard:PersonnelQualificationsWhenNoStateLicensing,CertificationorRegistrationRequirementsExist§418.
114(d)Standard:CriminalBackgroundChecks§418.
116ConditionofParticipation:CompliancewithFederal,State,andLocalLawsandRegulationsRelatedtotheHealthandSafetyofPatients§418.
116(a)Standard:MultipleLocations§418.
116(b)Standard:LaboratoryServicesPartI–InvestigativeProceduresI–IntroductionSurveyprotocolsandInterpretiveGuidelinesareestablishedtoprovideguidancetopersonnelconductingsurveysofhospices.
Theyservetoclarifyand/orexplaintheintentoftheregulations.
AllsurveyorsarerequiredtousetheminassessingcompliancewithFederalrequirements.
Thepurposeoftheprotocolsandguidelinesistodirectthesurveyor'sattentiontoavenuesofinvestigationinpreparationforthesurvey,conductingthesurvey,andevaluatingthesurveyfindings.
TheseprotocolsrepresenttheviewoftheCentersforMedicare&MedicaidServices(CMS)onrelevantareasanditemsthatmustbeinspected/reviewedundereachregulation.
Theuseoftheseprotocolspromotesconsistencyinthesurveyprocess.
Theprotocolsassurethatafacility'scompliancewiththeregulationsisreviewedinathorough,efficient,andconsistentmannersothatatthecompletionofthesurvey,surveyorshavesufficientinformationtomakecompliancedecisions.
AlthoughsurveyorsusetheinformationcontainedintheInterpretiveGuidelinesintheprocessofmakingadeterminationaboutahospice'scompliancewiththeregulations,theseguidelinesarenotbinding.
InterpretiveGuidelinesdonotestablishrequirementsthatmustbemetbyhospices,donotreplaceorsupersedethelaworregulations,andmaynotbeusedaloneasthesolebasisforacitation.
AllmandatoryrequirementsforhospicesaresetforthinrelevantprovisionsoftheSocialSecurityActandinregulations.
TheInterpretiveGuidelinesdohowever,containauthoritativeinterpretationsandclarificationofstatutoryandregulatoryrequirementsandareusedtoassistsurveyorsinmakingdeterminationsaboutahospice'scompliance.
SurveyTeamTheStatesurveyagency(SA),ortheCMSRegionalOffice(RO)forFederalteams,decidesthesizeoftheteam.
EachhospicesurveyteamshouldincludeatleastoneRNwithhospicesurveyexperience.
Othersurveyorswhohavetheexpertisetodeterminewhetherthehospiceisincompliancemaybeusedasneeded.
TrainingforHospiceSurveyorsHospicesurveyorsshouldhavethenecessarytrainingandexperiencetoconductahospicesurvey.
AllhospicesurveyorsmustattendaCMSsponsoredBasicHospiceSurveyorTrainingCourse.
NewsurveyorsmayaccompanytheteamaspartoftheirtrainingpriortocompletingtheCMSBasicHospiceSurveyorTrainingCourse.
TypesofHospiceSurveysA-InitialCertificationPriortotheinitialMedicarecertificationsurvey,aprospectivehospiceshouldnotifytheROand/ortheSAthatitwantstoapplyforMedicarecertification.
TheprospectivehospicemustcompleteaMedicareenrollmentapplication(FormCMS855A).
Thisformcanbefoundat:http://www.
cms.
hhs.
gov/MedicareProviderSupEnroll/02_EnrollmentApplications.
asp#TopOfPage.
TheassignedMedicareAdministrativeContractor(MAC)willreviewtheapplication,verifytheinformationandnotifytheROandSAoftheirenrollmentrecommendation.
Additionalinformationonthisprocessisavailablein§2005A.
InitialMedicareCertificationSurveyBeforetheSAortheNationalAccreditingOrganization(AO)withdeemingauthorityconductstheinitialMedicarecertificationsurvey,theSAmusthavereceivedwrittendocumentationsubmittedbytheprospectivehospicerequestinganinitialcertificationsurvey.
Atthetimeofthesurvey,theprospectivehospicemust:Beoperational;HavecompletedtheMedicareEnrollmentApplicationFormCMS-855AandhadthisformverifiedbytheassignedMAC;Haveprovidedcaretoaminimumof5hospicepatients(notrequiredtobeMedicarepatients.
)Atleast3hospicepatientsshouldbereceivingcareatthetimeoftheinitialMedicarecertificationsurvey.
Ifthehospiceislocatedinamedicallyunderservedarea,asdeterminedbytheCMSRO,theCMSROmayreducetheminimumnumberofpatientsfrom5to2.
Atleast1ofthe2requiredpatientsshouldbereceivingcarefromthehospiceatthetimeoftheinitialMedicaresurvey;Beprovidingallservicesneededbythepatientsactuallybeingserved;andBecapableofdemonstratingtheoperationalcapabilityofallfacetsofitsoperations.
Intheeventthatthehospicepatientsbeingservedatthetimeofthesurveydonotrequirethefullscopeofhospiceservices,verifythatthehospiceisfullypreparedtoprovideallservicesnecessarytomeetthehospiceCoPs.
ItisnotnecessarytoinspectthefacilitywheretheinpatientserviceswillbeprovidedunderarrangementorinspacesharewithaMedicarecertifiedfacility.
Thecontractfortheinpatientservicesmustbereviewedtoensurethatitisvalidandthereisnodoubtthatthehospicewillbeabletoprovidetheservicewhenneeded.
TheeffectivedateofMedicareparticipationcanbenoearlierthanthedatethehospiceispreparedtoprovidealloftherequiredservicesandmeetsallhospiceCoPs.
InnocasecantheeffectivedatebeearlierthanthedatethehospicemeetsalltheFederalrequirements(42CFR489.
13).
Allinitialhospicesurveysareunannouncedandmustverifycompliancewithalltheregulatoryrequirementscontainedin§418.
52thru§418.
116.
(See§2700A)B-RecertificationSurveyofParticipatingHospicesAllrecertificationhospicesurveysareunannouncedandmustverifycompliancewithalltheregulatoryrequirementscontainedat§418.
52thru§418.
116.
Ifanexistingcertifiedhospicehasanewinpatientunitoraninpatientunitthatitwishestorelocate,verifycompliancewiththeregulationsat§418.
110.
Routinelyconducttherecertificationsurveyatamultiplelocationofthehospice,ifapplicable,whenthatlocationservesmorepatientsthantheinitiallocationissuedtheCMScertificationnumber.
Wheneverpossible,visitalllocationsofthehospiceduringthesurvey.
Deficienciesfoundatanymultiplelocation(s)areapplicabletotheentirehospice.
C-Post-SurveyRevisitInsomecases,theSAmayverifycorrectionofdeficienciesthroughmail,telephoneorelectroniccontactinlieuofanon-sitevisit.
However,anon-sitevisitisrequiredforanyconditionleveldeficiency.
Throughtheon-sitevisitorothercontact,assessthehospicescorrectionofthedeficienciespreviouslycitedontheStatementofDeficienciesandPlanofCorrection,FormCMS-2567.
Thepurposeofthepost-surveyonsiterevisitistoreevaluatethespecificcareandservicesthatwerecitedduringthesurveythatcannotbeadequatelyassessedbymail,telephone,orelectroniccontact.
Thenatureofthedeficienciesdictatesthenecessityforandscopeofthepost-surveyrevisit.
Ifdeficiencieswereoriginallyidentifiedduringhomevisits,homevisitsmaybenecessaryontherevisit.
Conductasmanyhomevisitsasnecessarytoassesscompliance.
AssessthecomplianceofthehospiceonalldeficienciescitedontheFormCMS-2567.
Ifadeficiencyissubsequentlycorrected,theSAcompletesthePost-CertificationRevisitReport,FormCMS-2567B,asappropriate.
(Referto§2732Bforadditionalinformation.
)Ifatthetimeofthepost-surveyrevisit,somedeficiencieshavenotbeencorrected,oradditionaldeficienciesareidentified,theSAcompletesanotherFormCMS-2567summarizingthedeficienciesbydataprefixtag.
TheSAmayexamineallconditions,asneeded,todeterminecompliancestatus.
Thehospicemustprovideaplanofcorrectionincludingcompletiondatesfordeficienciesidentifiedduringapost-surveyrevisit.
D-ComplaintInvestigationsInvestigationandresolutionofcomplaintsisacriticalcertificationactivity.
Eachcomplaintagainstahospicemustbedocumented,investigatedandresolved.
FollowtheguidanceinChapter5forinvestigationsofcomplaints.
Ifthehospiceisfoundtohaveoneormorecondition-leveldeficienciesduringthecomplaintinvestigation,allconditionsmustbereviewed.
FollowtheInterpretiveGuidelinescontainedinPartIIofthisAppendix.
II–TheSurveyFocusThehospiceoutcome-orientedsurveyprocessemphasizesthehospicesperformanceanditseffectonpatients.
Theprocessfirstdirectsthesurveyortofocusontheservicesbeingprovided,andthentoexaminethestructuresandprocessesthatcontributetothequalityoftheservices.
Theprimaryfocusofthesurveyisonpatientoutcomes,thehospicespracticesinimplementingtherequirements,andprovisionofhospiceservices.
TheintentofthesurveyistoevaluateeachoftheCoPsinthemostefficientmannerpossible.
Thesurveyorconsiderstheinterrelatednessoftheregulationswhileevaluatingcompliancethroughobservations,interviews,homevisits,andrecordreviews.
III-TheSurveyTasksThehospicesurveyprocessconsistsofcompletingthefollowingtaskswithanassessmentoftheprincipalcomponentslistedbelow.
Task1Pre-SurveyPreparation;Task2EntranceInterview;Task3InformationGathering;Task4InformationAnalysis;Task5ExitConference,andTask6FormationoftheStatementofDeficiencies.
Task1–Pre-SurveyPreparationPriortoeachsurvey,reviewthehospice'sfileinaccordancewith§2704.
Inaddition,reviewtheInterpretiveGuidelines,whichcontaincriticalquestionstoaskduringtheentranceconferenceandthroughoutthesurvey.
Task2-EntranceInterviewTheentranceinterviewsetsthetonefortheentiresurvey.
Thesurveyormustestablishrapportwiththehospicestaff.
Duringthisinterview,gatherinformationtounderstandhowthehospiceorganizesitself,andprovideshospicecareandservicestopatients.
1.
Uponarrivalatthehospice,completethefollowingprimaryactivities:Presentidentificationandintroduceanysurveyteammembers;Requestameetingwithappropriatestaffbasedontheorganizationalcharacteristicsofthehospice.
Requestacopyoftheorganizationalchart;Informtheadministratorordesigneeofthepurposeofthesurvey;Asktheadministratorordesigneetoexplaintheorganization,servicesprovided(directlyandunderarrangement)andtherelationshiptoanycorporatestructure;Explainthesurveyprocess,andestimatethenumberofdaysonsite;Beawarethattheunannouncedsurveymaybedisruptivetothenormaldailyactivitiesofthehospice;Discusstheextenttowhichhospicestaffmaybeinvolvedduringthesurvey;Setupthescheduleforanynecessaryinterviewswithkeystaff(e.
g.
,medicaldirector,spiritualorpastoralcounselor,bereavementcounselor,volunteersupervisor,socialworker,RNcoordinator,etc.
);RequestthatthehospicecompletetheFormCMS-417,HospiceRequestforCertificationintheMedicareProgram(Exhibit72)andreturnittoyouassoonaspossible,butnolaterthanwithin24hoursoftheentranceconference,andRequestspacetowork.
Investigateanydiscrepanciesininformationobtainedduringtheentranceinterviewthroughobservation,interviewswithkeystaff,andareviewofsourcedocuments,asneeded,duringthesurvey.
2.
Requestthefollowinginformationduringtheentranceinterview:Verificationofaddressesofalllocationsand/orshortterminpatientfacilitiesusedbythehospice(eitherdirectlyorunderarrangements);Accesstoclinicalrecordsandtheequipmentnecessarytoreadanyclinicalrecordsmaintainedelectronically.
Thehospicemustalsoproduceapapercopyoftherecord,ifrequestedbythesurveyor;Informationgiventothepatientonadmissiontohospice;Documentationofhospiceaidetrainingand/orcompetencyevaluationsandin-servicetraining;Informationconcerningservicesnotprovideddirectly;Numberofunduplicatedadmissionsfortheentirehospiceduringtherecent12monthperiod,includingMedicare/Medicaidandprivatepaypatients;Numberofcurrentpatientswhoarereceivinghospicecareathome,inaninpatientfacility,SNF/NF,ICF/MRorotherfacility;Listoraccesstonamesofpatientsscheduledforahomevisitduringthesurvey;Accesstoallactivepatientnames(Medicare/Medicaid/privatepay)receivinghospiceservicesthatidentifiestheelectiondate,diagnosis,anddatetheinitialandcomprehensiveassessmentwascompleted.
Thiswillaidinselectingthesampleforhomevisitsandrecordreviews;Accesstobereavementrecordsforexpiredpatientswhoreceivedservicesduringthelast12months;Listofcurrentemployeesandvolunteers,includingnameandtitle;Listofcontractsasapplicable(e.
g.
,SNF/NF,DME,Pharmacy,Inpatientfacilities;Namesofkeystaff(e.
g.
,RNcoordinator(s)forIDG(s),andpersonsmostknowledgeableaboutthehospiceaides,homemakers,volunteers,infectioncontrol,qualityassessmentandperformanceimprovement(QAPI),in-servicetraining,clinicalsupervision,bereavement);Clinicalstaffpersonwhowillbetheprimaryresourcerespondingtothesurveyorsquestions;Documentationofgrievances/complaintsthatthehospicereceivedduringthepast12months;Personnelfiles,policiesandprocedures,andCLIAcertificate(ifapplicable,andDate(s)andtime(s)ofIDGreviewsandplanofcareupdates.
Task3-InformationGatheringThistaskincludesanorganized,systematic,andconsistentgatheringofinformationnecessarytomakedecisionsconcerningthehospice'scompliancewiththeCoPs.
RevieweachconditionusingtheInterpretiveGuidelinestoassistyou.
Throughoutyoursurveymaintainanopenandongoingdialoguewithhospicepersonnel.
Discussyourobservations,asappropriate,withteammembersandhospicepersonnel.
Givethehospicetheopportunitytoprovideadditionalinformation.
Fullyinvestigatetheissuesofconcernthroughfurtherobservation,interviewsanddocumentreviewsbeforemakingcompliancedecisions.
Payparticularattentiontothefollowingareasrelatedtopatientcareandorganizationalenvironment.
A–PatientCareIsthereevidenceduringthesurveythat:Thehospicepromotesandprotectstherightsofitspatients.
Thehospiceinterdisciplinarygroup(IDG)gatherstheappropriatepatient/familyinformationneededtoperformaccuratecomprehensiveassessmentsandnecessaryupdatestotheassessment.
TheIDGworkstogethertodevelopandupdatetheindividualizedplanofcareforeachpatient,basedontheassessments,tomeettheidentifiedpatient/familyneedsandgoals.
(Duringthesurvey,itishelpfultoattendatleastapartofthescheduledIDGreviewsofthepatientsplansofcare,ifpossible.
)Thehospiceinvolvesthepatientand/orfamilyindevelopingtheplanofcare.
(Interviewswithstaff,patientsandfamilycanbehelpfulindetermininghowthehospiceinvolvespatient/familiesindevelopingtheplanofcare.
)AllmembersoftheIDGandallrelevantpatientcareproviders(e.
g.
,hospiceaide,volunteeretc.
,)sharecurrentrelevantinformationregardingeachpatient/familysstatus.
Thehospiceprovideseducationtothepatient/familyaboutthepatientsdiseaseprocess,thepalliationandmanagementofthepatientssymptoms,thesafeandeffectiveuseofmedicationandmedicalequipmentusedbythepatient,andthephysical,psychosocialandspiritualaspectsofthedyingprocess.
Allpersonnelarequalifiedandfurnishservicestothepatientinaccordancewithacceptedprofessionalstandardsofpractice.
Thehospiceassuresthathospiceaidesarecompetenttoprovidecaretotheirpatientsandsupervisedbyaregisterednurse.
Thehospicesinfectioncontrolprogramprotectspatients,families,visitors,andhospicepersonnelbypreventingandcontrollinginfectionsandcommunicablediseases.
Thehospicedevelops,implements,andmaintainsaneffective,ongoing,hospice-widedata-drivenqualityassessmentandperformanceimprovement(QAPI)program.
B–OrganizationalEnvironmentIsthereevidenceduringthesurveythat:Thegoverningbodyensuresthehospicehasanongoingprogramtopromotequalityassessmentandperformanceimprovement;Thehospiceadministratorassumesfullresponsibilityfortheday-to-dayoperationsofthehospice;Thehospiceunderstandstheprinciplessurroundingqualityassessmentandimplementseffectiveongoingperformanceimprovementprojectsutilizingdatacollected;Whenthehospiceidentifiestrendsthatindicatepotentialoractualproblems,ittakesfollowupactionstoresolvetheissue(s);Thehospiceprovidescarethatoptimizesthepatientscomfortanddignityandisconsistentwiththepatientandfamilyneedsandgoals;Thehospiceassumesoverallprofessionalmanagementresponsibilityforallservicesprovideddirectlyandunderarrangement;Nursingservices,physicianservices,drugsandbiologicalsareroutinelyavailableona24-hourbasis,7daysaweek.
Othercoveredservicesareavailableona24-hourbasiswhenreasonableandnecessarytomeettheneedsofthepatientandfamily;Theoncallsystemisoperationalona24hourbasissothatpatientscancontactthehospiceasnecessary;Drugs,treatmentsandmedicalsuppliesareprovidedasneededforthepalliationandmanagementoftheterminalillnessandrelatedconditions,andThehospicemakesarrangementsforanynecessaryinpatientcareaccordingto§418.
108,andretainsprofessionalmanagementresponsibilityforservicesfurnishedbyinpatientfacilitystaff.
C–ClinicalRecordsTheminimumnumberofclinicalrecordstobereviewedduringthehospicesurveywillbethesumofthenumberofclinicalrecordswithouthomevisitsandthenumberofclinicalrecordswithhomevisits.
Seechartbelow.
UnduplicatedAdmissionsMin#OfRecordReviewsWithoutHomeVisitMin#OfRecordReviewsWithHomeVisitTotalRecordReviews1508311150-75010313751-1250124161251ormore155201.
SelectionofClinicalRecordsThenumberofrecordreviewswithouthomevisits,basedonthetotalnumberofunduplicatedadmissionsduringarecent12-monthperiod,isasfollows:NumberofUnduplicatedHospicePatientsAdmittedDuringRecent12MonthPeriodMinimumNumberofRecordReviewsWithoutHomeVisitsofPatientsAdmittedDuringRecent12MonthPeriodLessthan1508150–75010751–1250121,251ormore15ormoreThesampleisselectedtocapturethedifferenttypesofsettingsinwhichthehospiceprovidescare(i.
e.
,routinehomecareinaprivateresidenceornursingfacility,aswellasinpatientcareprovideddirectlyorunderarrangement),andtoincludepatientswithdifferentterminaldiagnoses.
Inadditiontothesampleofrecordsselected,reviewarecordofahospicepatientwhohasbeendischargedfromanursinghomeandapatientwhohasrevokedthehospicebenefitifthereareconcernsaboutdischargeorrevocation.
Inaddition,reviewasampleof2-3bereavementplansofcarefromalistofpatientswhohavediedwithinthepast12monthstodetermineifthebereavementservicesprovidedreflectedtheneedsofthebereaved.
2.
ClinicalRecordReviewThearrangementandformatofclinicalrecordsvaryamonghospices.
Tominimizetimespentinreviewingaclinicalrecordandtomaximizethesubstantiveinformationthatcanbeobtained,usethefollowingapproach:Reviewthearrangementandformatofoneortwoclinicalrecordswiththehospicestaffpersondesignatedtoansweryourquestionsabouthowservicesareorganized,delivered,andevaluated.
Askhim/herwhereyouarelikelytofindtheinformationintheclinicalrecord.
Iftherecordismaintainedelectronically,thehospicemustprovideallequipmentnecessarytoreadtherecordinitsentirety.
Thehospicemustalsoproduceapapercopyoftherecord,ifrequestedbythesurveyor.
Determineifthepatientscomprehensiveassessmentandupdatestotheassessmentweretimelyandaccuratelyreflectthepatient/familysstatus.
ReviewtheplanofcaretoidentifywhethertheIDGusedthecomprehensiveassessmentandassessmentupdatestomakesoundcareplanningdecisionsappropriatetothepatient/familyneeds.
DetermineiftheplanofcareiscurrentandreflectstheparticipationofallmembersoftheIDG.
Evaluatethehospicesabilitytocoordinatecareandservicesthatoptimizepatientcomfortanddignity.
Reviewasampleofclinicalnotationsbyallpersonnelprovidingservices.
Determineiftheplanofcareandfrequencyofvisitsbyhospicepersonnelsupportthefindingsofthecomprehensiveassessmentandupdatestotheassessment.
DidtheagencysinterventionsfollowtheplanofcareWasthedocumentationspecifictochangesinthepatient/familysstatusDeterminehowthehospiceensurescoordinationofservicesamongandbetweentheIDGmembersandotherpersonnelprovidingservices.
Whatevidenceisfoundintheclinicalrecord(s)thatthisisoccurringDetermineifhospiceaideclinicalnotesdocumentthestatusofthepatient.
DothehospiceaidesreportchangesinthepatientsconditiontoaregisterednurseIfyoucannotfindinformationoryouhavequestionsaboutthecontentoftheclinicalrecord,askthehospicestafftoeitherfindtheinformationorhelpyouunderstanditscontent.
D-HospiceHomeVisitProceduresHomevisitsmustbemadetoasampleofhospicepatientsduringahospicesurvey.
Intheeventthatthehospiceispartofanotherprovidertype(e.
g.
,HHA)besurethatthepatientsselectedforthehomevisitduringthehospicesurveyarereceivinghospiceservicesfromthehospice,notpalliativecareorhomehealthservicesfromtheHHA.
TerminallyillpatientswhodonotwishtoelecttheMedicarehospicebenefitandareadmittedtoaMedicareHHAforservicesunderadually-certifiedHHA/HospiceareconsideredHHApatients.
ThesepatientsmaynotbeselectedforclinicalrecordreviewsorhomevisitsduringtheMedicarehospicecertificationsurvey.
Homevisitsyieldvaluableinformationabouthowthehospice:Promotesandprotectstherightsofpatients;Conductstheinitialandcomprehensiveassessments;Updatestheassessment;Implementstheplanofcare;Promotespatient/familysatisfaction;Providesdrugs,treatments,servicesanddurablemedicalequipment(DME);Usesvolunteers,andProvidestherequiredlevelofcarerelatedtotheneedsofthepatient.
1-PatientSelectionforHomeVisit.
Thenumberofrecordreviewswithhomevisits,basedonthetotalnumberofunduplicatedadmissionsduringarecent12-monthperiod,isasfollows:NumberofUnduplicatedHospicePatientsAdmittedDuringRecent12MonthPeriodMinimumNumberofRecordReviewsWithHomeVisitsofPatientsAdmittedDuringRecent12MonthPeriodLessthan7503751-125041251ormore5Thesurveyoridentifiesandselectspatientswhowillreceivehospiceservicesduringtheremainingdaysofthesurvey.
Additionalhomevisitsmaybemadeasdesiredorindicatedtodeterminethescopeofanyconcernsinitiallyidentifiedbyhomevisitsorrecordreviews.
Conductarecordreviewofeachpatientselectedforahomevisiteitherbeforeorafterthevisit.
Thesampleisselectedtocapturethedifferenttypesofsettingsinwhichthehospiceprovidesroutinehomecare(i.
e.
,privateresidence,nursingfacility,etc.
,)andincludepatientswithdifferenttypesofterminaldiagnoses.
NOTE:Homevisitsarenotrequiredtobelimitedtopatientsreceivingroutinehomecare.
Ifinreviewingcontractsorotherdocumentation(e.
g.
,clinicalrecords,plansofcare),questionsariseconcerningthehospicesprovisionofinpatientcare,eitherdirectlyorunderarrangements,conductanonsitevisittotheinstitutionprovidingtheinpatientservicestoreviewthecareprovided.
See§2084.
2.
2-Patient'sConsentYoumayvisitpatientsfromallpaymentsourcesthathavegivenpermissionforthevisit.
PatientsmustunderstandthatahomevisitisvoluntaryandrefusaltoconsenttoahomevisitwillnotaffectMedicare/Medicaidbenefitstowhichthebeneficiariesareentitled.
Havethepatient(orrepresentative)signthehospiceconsentformbeforebeginningthevisit.
Youmayobtainthissignatureuponarrivalatthepatient'sresidenceifpriorverbalconsenthasbeenobtained.
(SeeModelConsentforHospiceHomeVisitform(Exhibit128).
Itisimportanttocontactthepatientbeforeyouarriveatthehomeorplaceofresidence,ifpossible,becausethefirstonsitecontactmaybeintimidatingtothepatient/familyormaygeneratesomefearthatwouldinterferewithaccesstothepatientshomeorthequalityoftheinterview.
Inmostsituations,thehospicerepresentativewhoprovidescareorservicesshouldcontactthepatient/familytorequestpermissionandmakethearrangementsforthehomevisit.
However,youmaychoosetocontactthepatient/familydirectly.
Thecontactrequestingthevisitshouldbemadeinaneutral,non-alarmingmanner,withoutsuggestingthatthereisaproblem.
3-VisitProcedureWorkwiththehospiceadministratorordesigneetodevelopavisitschedulethatistheleastdisruptivetotheusualschedulingofvisits.
Ifapatientrefusestohavethesurveyoraccompanythehospicerepresentative,selectanalternatepatient.
Ahomevisitismoreeffectiveinassessingthescopeandqualityofcarebeingprovidedifyouobservehowhospicepersonnelimplementoneormorepartsofthepatient'splanofcare.
Inordertoobservethedeliveryofcare,attempttoschedulehomevisitsatatimewhenthehospiceisactuallyprovidingservices.
Usethefollowingprocedurestoselectpatientsforhome/residencevisits:Identifyandselectpatientswhowillbevisitedbythehospiceduringthedaysofthescheduledsurvey,andwhomeetthecriteriaforpatientselection.
Thesamplesizeshouldincludeafewmorepatientsthanthenumberofproposedvisitstoaccommodatepossiblerefusalsandincludedifferentindividualsprovidingtheservices(e.
g.
,nurse,socialworker,hospiceaide).
Requestacopyofthemostrecentplanofcareforeachpatientselectedforahomevisit.
Ifthehospicedoesnothaveanyvisitsscheduled,invitethehospicetohaveoneofitsemployeesaccompanyyouonhomevisitstopatientsthatyouhaveselected.
However,theremaybecircumstances(i.
e.
,complaints)thatshouldbereviewedduringahomevisitwithoutthehospicerepresentativebeingpresent.
4-HomeVisitAtthepatient'shomeyoumaytalkwiththepatient,family/caregiverorboth.
Indicatethattheprimarypurposeofthehomevisitistoevaluatetheeffectivenessofthehospice'sservices.
Conductthevisitwithsensitivityandunderstandingofthelifecrisesthatthepatientandcaregiverareexperiencing.
RefertotheInterpretiveGuidelinesforquestionstouseduringthehomevisittohelpyouunderstandthepatient/familysatisfactionwiththehospicecare/servicesandtoassessthescope,qualityandeffectivenessoftheplanofcareandservicesdelivered.
Thefollowingadditionalquestionsmaybeusefulduringthehomevisit:WhocomestoseeyoufromthehospiceHowfrequentlydoyoureceivecareandservicesHasthenursetalkedwithyouabouttreatingyourpainand/orotheruncomfortablesymptomsHavetherebeenanyinstanceswherethehospicefailedtorespondtothepatientsrequestforpainmedicationorsymptommanagementHaveyoueverhadtowaitlongtogetmedicationfordiscomfortIfyes,howlongwasthewaitHassomeonefromthehospicegivenyouachancetotalkaboutyourreligiousorspiritualbeliefsorconcernsHaveyoueverneededtocallthehospiceonweekends,evenings,nights,orholidaysWhatwasyourexperiencewiththisHaveyoureceivedcareinanyothersettingwhileunderhospicecareIfso,whatwasyourexperienceSinceyouhavebeenreceivingcarefromthehospice,haveyouhadanyout-of-pocketexpensesforyourhealthcareIfyes,whatkindHowsatisfiedareyouwiththeservicesprovidedDoyouhaveanysuggestionsforimprovementWouldyourecommendthishospiceObserve,butdonotinterferewith,thedeliveryofcareortheinteractionsbetweenthehospicerepresentativeandthepatient/familyand/orcaregiver.
Becontinuouslyawarethatasaguestinapatientshome/residence,courtesy,commonsense,andsensitivitytotheimportanceofanindividualsownenvironmentisabsolutelyessential,regardlessofthecondition.
Additionalgeneralinformationaboutfacilitypersonnelaccompanyingsurveyorsandphysicalcontactofpatientsbysurveyorsisincludedin§2713Aand§2713Bofthismanual.
Discontinuetheinterviewif:Thepatientshowssignsofbeinguncomfortableorseemsreluctanttotalk,andifafteraskingthepatient,theywouldratherdiscontinuethediscussion;orThepatientappearstired,overlyconcerned,agitated,etc.
,andwouldliketoendtheinterview;orInyourjudgment,itappearstobeinthepatient'sbestinteresttoendtheinterview.
E-Follow-UpProceduresCheckanyspecificpatient/familycomplaintsconcerningthehospice'sdeliveryofitemsandserviceswiththehospicetobesurethattherearenomisunderstandingsandthatthepatient'splanofcareisbeingfollowed.
Ifhospicedeficienciesareidentifiedasaresultofahomevisitand/orclinicalrecordreview,citethesedeficienciesontheFormCMS-2567.
Thesedeficienciescouldinclude,butarenotlimitedto:Failuretopromoteandprotectthepatientsrights;Failuretoaccuratelyconductapatient-specificcomprehensiveassessmentthatidentifiesthepatient/familysneedforhospicecareandservices,andthepatient/familysneedforphysical,psychosocial,emotional,andspiritualcare;Failuretodevelopandimplementaplanofcarethatmeetstheneedsidentifiedintheinitialorcomprehensiveassessment;FailureoftheIDGtomeetthephysical,medical,psychosocial,emotional,andspiritualneedsofthehospicepatient/family;Failuretoprovideallcoveredservices,asnecessary,includingthecontinuoushomecarelevelofcare,respitecareandshort-terminpatientcare;Failuretoprovidenursingandphysicianservices,drugsandtreatmentsona24-hourbasis;Failuretoretainprofessionalmanagementresponsibilityforallhospiceservicesprovidedundercontracttopatients,andFailuretodevelop,implement,andmaintainaneffective,ongoing,hospice-widedata-drivenQAPIprogram.
Task4-InformationAnalysisA–GeneralTheinformationanalysisprocessrequiressurveyorstoreviewtheinformationgatheredduringthesurveyandmakejudgmentsaboutthecomplianceofthehospice.
Donotmakeanevaluationofwhetherafindingconstitutesadeficiencyorwhetheraconditionleveldeficiencyexistsuntilallnecessaryinformationhasbeencollected.
Additionalactivitiesandinvestigationthroughrecordreview,homevisitobservationsandinterviewsshouldsubstantiateandsupportanyfindingsofnon-compliancewiththeCoPs.
Reviewallyourfindingsanduseyourprofessionaljudgmenttodecidewhetherfurtherinformationgatheringisnecessary.
B–AnalysisAnalyzeyourfindingsrelativetoeachrequirementforthe:Effectorpotentialeffectonthepatient(s);Degreeofseverity;Frequencyofoccurrence,andImpactonthedeliveryofservices.
Anisolatedincidentthathaslittleornoeffectonthedeliveryofpatientservicesmaynotwarrantadeficiencycitation.
Conversely,aconditionmaybeconsideredoutofcomplianceforoneormoredeficienciesif,inyourjudgment,thedeficiencyconstitutesasignificantorseriousproblemthatadverselyaffects,orhasthepotentialtoadverselyaffectthepatient(s).
Adeficiencymustbebasedonthestatuteortheregulations.
Citationofadeficiencymustnotbebasedonaviolationofaguidelinealone.
Ineachcaseyoumustdetermine,basedonthefactsandcircumstancesexistingatthetimeandanyfurtherinvestigationasmaybewarranted,whetheradeficiencyexistsbasedontheapplicablestatutoryorregulatoryprovision.
Thesurveyorsroleistoassessthequalityofcareandservicesthehospiceprovidesandrelatethosefindingstothestatutoryandregulatoryrequirements.
Whendeficienciesarefoundduringasurvey,thesurveyorshouldexplaintotheproviderwhatthedeficiencyissotheproviderunderstandswhytherequirementisnotmet.
Itisnotthesurveyorsjobtoprovideconsultationonhowtofixthedeficiencies.
See§4018forfurtherinformationontheregulatoryroleofthesurveyor.
Task5-ExitConferenceTheexitconferenceisheldattheendofthesurveyinaccordancewith§2724.
Thepurposeoftheexitconferenceistoinformthehospiceofobservationsandpreliminaryfindingsofthesurvey.
Becauseofongoingdialoguebetweenthesurveyor(s)andhospicestaffduringthesurvey,thereshouldbefewinstanceswherethehospiceisnotawareofthesurveyorconcernspriortotheexitconference.
Implementthefollowingguidelinesduringtheconference:Conducttheexitconferencewiththehospiceadministrator,clinicalsupervisorsandotherstaffinvitedbythehospice;Describetheregulatoryrequirementsthatthehospicedoesnotmeetandthefindingsthatsubstantiatethesedeficiencies.
Avoidusingdatatagnumberswhenreferringtoyourfindings;PresenttheFormCMS-2567onsite,orinaccordancewiththeStateagency'spolicy,butnolaterthan10workingdaysaftertheexitconference,andProvideinstructionsandtimeframeforsubmittingaplanofcorrection.
TheplanofcorrectionmustbesubmittedtotheSAwithin10calendardaysafterreceiptoftheFormCMS-2567.
(Referto§2724and§2728foradditionalinformation).
Referto§2724foradditionalinformationontheexitconference,presenceofcounsel,tapingoftheconference,andsituationsthatwouldjustifyrefusaltoconductorcontinueanexitconference.
Task6-FormationoftheStatementofDeficienciesFollow§2728forpreparationoftheStatementofDeficienciesandPlanofCorrection.
Refertothedocument―PrinciplesofDocumentationfortheStatementofDeficiencies‖fordetailedinstructionsoncompletingtheFormCMS-2567.
PartII–InterpretiveGuidelines§418.
3Definitions.
Forthepurposesofthispart—"Attendingphysician"meansa—(1)(i)DoctorofmedicineorosteopathylegallyauthorizedtopracticemedicineandsurgerybytheStateinwhichheorsheperformsthatfunctionoraction;or(ii)Nursepractitionerwhomeetsthetraining,education,andexperiencerequirementsasdescribedin§410.
75(b)ofthischapter.
(2)Isidentifiedbytheindividual,atthetimeheorsheelectstoreceivehospicecare,ashavingthemostsignificantroleinthedeterminationanddeliveryoftheindividual'smedicalcare.
Bereavementcounselingmeansemotional,psychosocial,andspiritualsupportandservicesprovidedbeforeandafterthedeathofthepatienttoassistwithissuesrelatedtogrief,loss,andadjustment.
Capperiodmeansthetwelve-monthperiodendingOctober31usedintheapplicationofthecaponoverallhospicereimbursementspecifiedin§418.
309.
Clinicalnotemeansanotationofacontactwiththepatientand/orthefamilythatiswrittenanddatedbyanypersonprovidingservicesandthatdescribessignsandsymptoms,treatmentsandmedicationsadministered,includingthepatient'sreactionand/orresponse,andanychangesinphysical,emotional,psychosocialorspiritualconditionduringagivenperiodoftime.
Comprehensiveassessmentmeansathoroughevaluationofthepatientsphysical,psychosocial,emotionalandspiritualstatusrelatedtotheterminalillnessandrelatedconditions.
Thisincludesathoroughevaluationofthecaregiversandfamilyswillingnessandcapabilitytocareforthepatient.
Dietarycounselingmeanseducationandinterventionsprovidedtothepatientandfamilyregardingappropriatenutritionalintakeasthepatientsconditionprogresses.
Dietarycounselingisprovidedbyqualifiedindividuals,whichmayincludearegisterednurse,dietitianornutritionist,whenidentifiedinthepatientsplanofcare.
Employeemeansapersonwho:(1)worksforthehospiceandforwhomthehospiceisrequiredtoissueaW-2formonhisorherbehalf;or(2)ifthehospiceisasubdivisionofanagencyororganization,anemployeeoftheagencyororganizationwhoisassignedtothehospice;or(3)isavolunteerunderthejurisdictionofthehospice.
Hospicemeansapublicagencyorprivateorganizationorsubdivisionofeitherofthesethatisprimarilyengagedinprovidinghospicecareasdefinedinthissection.
HospicecaremeansacomprehensivesetofservicesdescribedinSection1861(dd)(1)oftheAct,identifiedandcoordinatedbyaninterdisciplinarygroup(IDG)toprovideforthephysical,psychosocial,spiritual,andemotionalneedsofaterminallyillpatientand/orfamilymembers,asdelineatedinaspecificpatientplanofcare.
Initialassessmentmeansanevaluationofthepatientsphysical,psychosocialandemotionalstatusrelatedtotheterminalillnessandrelatedconditionstodeterminethepatientsimmediatecareandsupportneeds.
LicensedprofessionalmeansapersonlicensedtoprovidepatientcareservicesbytheStateinwhichservicesaredelivered.
MultiplelocationmeansaMedicare-approvedlocationfromwhichthehospiceprovidesthesamefullrangeofhospicecareandservicesthatisrequiredofthehospiceissuedthecertificationnumber.
Amultiplelocationmustmeetalloftheconditionsofparticipationapplicabletohospices.
Palliativecaremeanspatientandfamily-centeredcarethatoptimizesqualityoflifebyanticipating,preventing,andtreatingsuffering.
Palliativecarethroughoutthecontinuumofillnessinvolvesaddressingphysical,intellectual,emotional,social,andspiritualneedsandtofacilitatepatientautonomy,accesstoinformation,andchoice.
PhysicianmeansanindividualwhomeetsthequalificationsandconditionsasdefinedinSection1861(r)oftheActandimplementedat§410.
20ofthischapter.
Physiciandesigneemeansadoctorofmedicineorosteopathydesignatedbythehospicewhoassumesthesameresponsibilitiesandobligationsasthemedicaldirectorwhenthemedicaldirectorisnotavailable.
RepresentativemeansanindividualwhohastheauthorityunderStatelaw(whetherbystatuteorpursuanttoanappointmentbythecourtsoftheState)toauthorizeorterminatemedicalcareortoelectorrevoketheelectionofhospicecareonbehalfofaterminallyillpatientwhoismentallyorphysicallyincapacitated.
Thismayincludealegalguardian.
Restraintmeans(1)Anymanualmethod,physicalormechanicaldevice,material,orequipmentthatimmobilizesorreducestheabilityofapatienttomovehisorherarms,legs,body,orheadfreely,notincludingdevices,suchasorthopedicallyprescribeddevices,surgicaldressingsorbandages,protectivehelmets,orothermethodsthatinvolvethephysicalholdingofapatientforthepurposeofconductingroutinephysicalexaminationsortests,ortoprotectthepatientfromfallingoutofbed,ortopermitthepatienttoparticipateinactivitieswithouttheriskofphysicalharm(thisdoesnotincludeaphysicalescort);or(2)Adrugormedicationwhenitisusedasarestrictiontomanagethepatientsbehaviororrestrictthepatientsfreedomofmovementandisnotastandardtreatmentordosageforthepatientscondition.
Seclusionmeanstheinvoluntaryconfinementofapatientaloneinaroomoranareafromwhichthepatientisphysicallypreventedfromleaving.
Terminallyillmeansthattheindividualhasamedicalprognosisthathisorherlifeexpectancyis6monthsorlessiftheillnessrunsitsnormalcourse.
L500(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52ConditionofParticipation:Patient'srightsL501(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)Thepatienthastherighttobeinformedofhisorherrights,andthehospicemustprotectandpromotetheexerciseoftheserights.
L501(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(a)Standard:Noticeofrightsandresponsibilities.
(1)Duringtheinitialassessmentvisitinadvanceoffurnishingcarethehospicemustprovidethepatientorrepresentativewithverbal(meaningspoken)andwrittennoticeofthepatient'srightsandresponsibilitiesinalanguageandmannerthatthepatientunderstands.
InterpretiveGuidelines§418.
52(a)(1)Whenreferenceismadeto"patient"intheGuidelines,italsoreferstoanypersonwhomay,underStatelaw,actonthepatientsbehalfwhenthepatientisunabletoactforhimorherself.
Thatpersonisreferredtoasthepatientssurrogateorrepresentative.
Ifacourthasformallydeclaredthepatientincompetent,thesurrogateorrepresentativeiswhomeverthecourtguardian,conservator,orcommitteeappointed.
Thehospiceshouldverifythattherepresentativehasthenecessaryauthority.
Forexample,acourt-appointedconservatormighthavethepowertomakefinancialdecisions,butnothealthcaredecisions.
Allhospicepatientsshouldbeawareoftheirrightsandresponsibilitiesbeforethehospicebeginstoprovidecare.
Thehospicemustverballyexplainthepatientrightsandresponsibilitiestoallpatientsacceptedforcare(orexplaintherightstothepatientsrepresentativeifthepatientisphysicallyormentallyincapacitated).
Theremustbeevidencethatthehospiceconscientiouslytried,withintheconstraintsoftheindividualsituation,toinformthepatient/familybothverbally(spoken)andinwritingofpatientrightsandresponsibilities.
Ifapatientisabletoreadandunderstandwrittenmaterialswithoutassistance,anoralsummary,alongwiththecompletewrittendocumentationisacceptable.
ForthepatientwhodoesnotspeakorunderstandEnglish,hospicesshouldmakeallreasonableeffortstosecureaprofessional,objectivetranslatorforhospice-patientcommunications,includingthoseinvolvingthenoticeofpatientrightsandresponsibilities.
Thehospicemayonlyusefamilyandfriendsastranslatorsforthepatientwhenanobjectivetranslatorcannotbesecuredbythehospiceorifthepatientspecificallyrequeststhisapproach.
Hospicesshouldmakeallreasonableeffortstohavewrittencopiesofthenoticeofrightsandresponsibilitiesavailableinthelanguage(s)thatarecommonlyspokeninthehospicesservicearea.
Forthosepatientswhospeaklanguagesinareaswhereprofessionaltranslatorsforthoselanguagesarenotreadilyavailable,usingfamilyandfriendsofthepatientisanacceptableoptionifthepatientagrees.
FurtherinformationonthistopicisavailablefromtheDepartmentofHealthandHumanServices,OfficeforCivilRightsPolicyGuidance:TitleVIProhibitionAgainstNationalOriginDiscriminationAsItAffectsPersonsWithLimitedEnglishProficiency.
ProceduresandProbes:§418.
52(a)(1)Askthehospiceforacopyofthematerialtheyprovidetopatientsortheirrepresentativeonadmission.
Duringhomevisits,askthepatient/familyifthehospiceinformedthemoftheirrightsandresponsibilities,and,ifso,howandwhen.
Theyshouldbeabletogive,intheirownwords,examplesofhowtherightsapplytothecarebeingreceivedandanyconcernstheyhaveaboutfinancialimplicationsoftheitemsorservicestheyreceive.
Theyshouldalsobeabletoexplainhowtoaccessthehospicestaff.
Ifthepatientorrepresentativeisvagueinansweringquestions,askforthewrittenpatientrightsandresponsibilitiesinformationthatthehospiceprovidedhimorherasresourcematerial,priortofurnishingcare.
L503(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(a)(2)-ThehospicemustcomplywiththerequirementsofsubpartIofpart489ofthischapterregardingadvancedirectives.
Thehospicemustinformanddistributewritteninformationtothepatientconcerningitspoliciesonadvancedirectives,includingadescriptionofapplicableStatelaw.
InterpretiveGuidelines§418.
52(a)(2)Advancedirectivesgenerallyrefertowrittenstatementsorinstructions,completedinadvanceofaseriousillness,abouthowanindividualwantsmedicaldecisionsmade.
Thetwomostcommonformsofadvancedirectivesarealivingwillandadurablemedicalpowerofattorneyforhealthcare.
Itisthepatientsrighttoformulateanadvancedirectiveshouldhe/shewishtodoso.
Thepatientsadmissiontohospiceshouldnotbeaffectedbyhis/herdesirenottoformulateanadvancedirectiveorbythecontentsofanadvancedirective.
TheremaybeStatespecificrequirementsforadvancedirectivesthatmustbefollowed.
Thehospicesobligationsunder42CFR489.
102includethefollowingrequirements:Hospicesmustmaintainwrittenpoliciesandproceduresconcerningadvancedirectiveswithrespecttoalladultindividualsreceivingmedicalcarebyorthroughtheproviderandarerequiredto:(1)Providewritteninformationtosuchindividualsconcerning:(i)Anindividual'srightsunderStatelaw(whetherstatutoryorrecognizedbythecourtsoftheState)tomakedecisionsconcerningsuchmedicalcare,includingtherighttoacceptorrefusemedicalorsurgicaltreatmentandtherighttoformulate,attheindividual'soption,advancedirectives.
Providersarepermittedtocontractwithotherentitiestofurnishthisinformationbutarestilllegallyresponsibleforensuringthattherequirementsofthissectionaremet.
Providersaretoupdateanddisseminateamendedinformationassoonaspossible,butnolaterthan90daysfromtheeffectivedateofthechangestoStatelaw;and(ii)Thewrittenpoliciesoftheproviderororganizationrespectingtheimplementationofsuchrights,includingaclearandprecisestatementoflimitationiftheprovidercannotimplementanadvancedirectiveonthebasisofconscience.
Ataminimum,aprovider'sstatementoflimitationshould:(A)Clarifyanydifferencesbetweeninstitution-wideconscienceobjectionsandthosethatmayberaisedbyindividualphysicians;(B)Identifythestatelegalauthoritypermittingsuchobjection,and(C)Describetherangeofmedicalconditionsorproceduresaffectedbytheconscienceobjection.
(2)Documentinaprominentpartoftheindividual'scurrentmedicalrecord,orpatientcarerecordinthecaseofanindividualinareligiousnonmedicalhealthcareinstitution,whetherornottheindividualhasexecutedanadvancedirective;(3)Notconditiontheprovisionofcareorotherwisediscriminateagainstanindividualbasedonwhetherornottheindividualhasexecutedanadvancedirective;(4)EnsurecompliancewithrequirementsofStatelaw(whetherstatutoryorrecognizedbythecourtsoftheState)regardingadvancedirectives.
TheprovidermustinformindividualsthatcomplaintsconcerningtheadvancedirectiverequirementsmaybefiledwiththeStatesurveyandcertificationagency;(5)Provideforeducationofstaffconcerningitspoliciesandproceduresonadvancedirectives,and(6)Provideforcommunityeducationregardingissuesconcerningadvancedirectivesthatmayincludematerialrequiredinparagraph(a)(1)ofthissection,eitherdirectlyorinconcertwithotherprovidersandorganizations.
Separatecommunityeducationmaterialsmaybedevelopedandused,atthediscretionofproviders.
Thesamewrittenmaterialsdonothavetobeprovidedinallsettings,butthematerialshoulddefinewhatconstitutesanadvancedirective,emphasizingthatanadvancedirectiveisdesignedtoenhanceanincapacitatedindividual'scontrolovermedicaltreatment,anddescribeapplicableStatelawconcerningadvancedirectives.
Aprovidermustbeabletodocumentitscommunityeducationefforts.
Hospicesmustfurnishthisinformationtothepatientatthetimeofinitialreceiptofhospicecarebytheindividualfromthehospice.
Hospices:1.
Arenotrequiredtoprovidecarethatconflictswithanadvancedirective;and2.
Arenotrequiredtoimplementanadvancedirectiveif,asamatterofconscience,itcannotimplementanadvancedirectiveandStatelawallowsthehospicetoconscientiouslyobject.
Ifanadultindividualisincapacitatedatthetimeofadmissionoratthestartofcareandisunabletoreceiveinformation(duetotheincapacitatingconditionsoramentaldisorder)orarticulatewhetherornotheorshehasexecutedanadvancedirective,thenthehospicemaygiveadvancedirectiveinformationtotheindividual'sfamilyorsurrogateinthesamemannerthatitissuesothermaterialsaboutpoliciesandprocedurestothefamilyoftheincapacitatedindividualortoasurrogateorotherconcernedpersonsinaccordancewithStatelaw.
Thehospiceisnotrelievedofitsobligationtoprovidethisinformationtotheindividualonceheorsheisnolongerincapacitatedorunabletoreceivesuchinformation.
Follow-upproceduresmustbeinplacetoprovidetheinformationtotheindividualdirectlyattheappropriatetime.
CompliancewiththeadvancedirectivesrequirementsisnecessaryforcontinuedparticipationintheMedicareandMedicaidprograms.
L504(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(a)(3)-Thehospicemustobtainthepatient'sorrepresentative'ssignatureconfirmingthatheorshehasreceivedacopyofthenoticeofrightsandresponsibilities.
Procedure§418.
52(a)(3)Reviewtheclinicalrecordforevidenceofthepatientsorrepresentativessignatureconfirmingreceiptofthenoticeofrightsandresponsibilities.
L505(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(b)Standard:Exerciseofrightsandrespectforpropertyandperson(1)Thepatienthastheright:(i)Toexercisehisorherrightsasapatientofthehospice;(ii)Tohavehisorherpropertyandpersontreatedwithrespect;(iii)Tovoicegrievancesregardingtreatmentorcarethatis(orfailstobe)furnishedandthelackofrespectforpropertybyanyonewhoisfurnishingservicesonbehalfofthehospice;and(iv)Tonotbesubjectedtodiscriminationorreprisalforexercisinghisorherrights.
InterpretiveGuidelines§418.
52(b)(1)(i)-(iv)Patientsmustbefreetoexercisetheirrightswithoutfearofreprisalfromthehospice.
Thehospicemustnothamper,compel,treatdifferentially,orretaliateagainstapatientorfamilyforexercisingthepatientsrights.
Thehospicemustassurethatitsstaffwillprotectpatientsrightsandwillinvolvepatientsindecisionsabouttheircare,treatmentandservices.
Agrievanceisaformalorinformalwrittenorverbalcomplaintthatismadetoanyhospiceemployee,includingvolunteersandindividualsfurnishinghospiceservicesunderarrangement,byapatientorthepatientsrepresentativeregardingthepatientscare,abuse,neglect,ormisappropriationofproperty.
ProceduresandProbes§418.
52(b)(1)(i)-(iv)Reviewpatientadmissioninformationforinstructionsonmakingacomplaint.
Noteanypatient-describedproblemsrecordedeitherinthehospicesdocumentationofcomplaintsreceivedorintheclinicalrecordreviews,andnoteiftheywereaddressedandresolved.
Ifresolutionoftheproblemwasnotpossible,thehospiceshoulddocumentboththeactionsattemptedandtheoutcomesachieved.
Asktoseedocumentationofcomplaintsmadebypatientsorpatientsfamiliesfortheprevious12monthsandreviewhowthehospicereceived,recorded,investigated,andresolvedthesecomplaints.
Isthereevidencethatthehospicestaffisawareofandfollowsthehospicespolicyforcomplaintinvestigationwhenapatient/familymakesacomplainttoastaffmemberPaycloseattentiontostaffremarksandstaffbehaviorthatmayrepresentdeliberateactionstopromoteortolimitapatientsautonomyorchoice.
Whointhehospiceisultimatelyaccountableforreceiving,investigatingandresolvinganypatientconcernsorproblemsthatcannotberesolvedatthestafflevelDuringhomevisits,askthepatient/familyiftheyknowhowandwhomtocontactiftheyhaveacomplaint.
Askthepatient,thepatientsfamily,guardianorotherlegalrepresentative,iftheyhaveanycommentsorconcerns,orhaveregisteredanygrievancesorcomplaintsaboutthehospiceoritsservices.
Ifthishasalreadyoccurred,askhowitwashandledandwhattheresultsoroutcomeswere.
L506(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(b)(2)-Ifapatienthasbeenadjudgedincompetentunderstatelawbyacourtofproperjurisdiction,therightsofthepatientareexercisedbythepersonappointedpursuanttostatelawtoactonthepatient'sbehalf.
ProceduresandProbes§418.
52(b)(2)Determineiftherightsofapatientadjudgedincompetentorwhohasarepresentativeactingonhis/herbehalfareexercisedbythelegallyappointedindividual.
Ifthehospiceiscurrentlycaringforapatientwhohasbeenadjudgedincompetent,andyouhavequestionsconcerningtheexerciseofthepatientsrights,youmaycontactthepatientslegalrepresentativeabouttheirinvolvementinplanningcare,treatmentandservicesdecisions.
Ifthepatientisselectedforahomevisit,obtainthelegalrepresentativesapprovalforthevisit.
L507(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(b)(3)-Ifastatecourthasnotadjudgedapatientincompetent,anylegalrepresentativedesignatedbythepatientinaccordancewithstatelawmayexercisethepatient'srightstotheextentallowedbystatelaw.
L508(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(b)(4)-Thehospicemust:(i)Ensurethatallallegedviolationsinvolvingmistreatment,neglect,orverbal,mental,sexual,andphysicalabuse,includinginjuriesofunknownsource,andmisappropriationofpatientpropertybyanyonefurnishingservicesonbehalfofthehospice,arereportedimmediatelybyhospiceemployeesandcontractedstafftothehospiceadministrator;InterpretiveGuidelines§418.
52(b)(4)(i)Allpatientcomplaintsandallegedorrealviolationsincludedinthisstandardmustbereportedimmediatelytothehospiceadministratorandshouldbeinvestigated,resolvedanddocumented.
―Abuse‖meansthewillfulinflictionofinjury,unreasonableconfinement,intimidation,orpunishmentwithresultingphysicalharm,painormentalanguish.
―Verbalabuse"includestheuseoforal,writtenorgesturedlanguagethatwillfullyincludesdisparagingandderogatorytermstopatientsortheirfamilies,orwithintheirhearingdistance,regardlessoftheirage,abilitytocomprehend,ordisability.
―Mentalabuse‖includes,butisnotlimitedto,humiliation,harassment,andthreatsofpunishmentordeprivation.
―Sexualabuse‖includes,butisnotlimitedto,sexualharassment,sexualcoercion,orsexualassault.
―Physicalabuse‖includes,butisnotlimitedto,hitting,slapping,pinchingandkicking.
Italsoincludescontrollingbehaviorthroughcorporalpunishment.
―Neglect‖meansfailuretoprovidegoodsandservicesnecessarytoavoidphysicalharmormentalanguish.
"Misappropriationofpatientproperty‖meansthedeliberatemisplacement,exploitation,orwrongful,temporaryorpermanentuseofapatientsbelongingsormoneywithoutthepatientsconsent.
―Injuriesofunknownsource‖–Aninjuryshouldbeclassifiedasan"injuryofunknownsource"whenbothofthefollowingconditionsaremet:1.
Thesourceoftheinjurywasnotobservedbyanypersonorthesourceoftheinjurycouldnotbeexplainedbythepatient;and2.
Theinjuryissuspiciousbecauseoftheextentoftheinjuryorthelocationoftheinjury(e.
g.
,theinjuryislocatedinanareanotgenerallyvulnerabletotrauma)orthenumberofinjuriesobservedatoneparticularpointintimeortheincidenceofinjuriesovertime.
―Immediately‖meansassoonaspossible,butnottoexceed24hoursafterdiscoveryoftheincident,intheabsenceofashorterStatetimeframerequirement.
ProceduresandProbes§418.
52(b)(4)(i)Askthehospiceadministratorifhe/shehasreceivedanyreportsoftheviolationslistedinthestandardandhowitwasresolved.
IsthereevidencethatallallegationsarethoroughlyinvestigatedArestaffmembersabletoidentifyvariousformsofabuseorneglectDostaffmembersknowwhattodoiftheywitnessanyviolationsofmistreatment,abuse,neglect,andinjuriesofunknownsourceormisappropriationofpatientpropertyDuringhomevisits,askpatientsandfamiliesiftheyhaveanyconcernsabouthowtheyortheirpropertyhavebeentreatedbythehospicestaff.
L509(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(b)(4)(ii)-Immediatelyinvestigateallallegedviolationsinvolvinganyonefurnishingservicesonbehalfofthehospiceandimmediatelytakeactiontopreventfurtherpotentialviolationswhiletheallegedviolationisbeingverified.
Investigationsand/ordocumentationofallallegedviolationsmustbeconductedinaccordancewithestablishedprocedures;ProceduresandProbes§418.
52(b)(4)(ii)Determinewhatproceduresareinplacetoaddresshowthehospicewillprotectpatientsfromrealorperceivedabuse,neglectorexploitationfromstaff,volunteers,orfamilymembers.
HowdoesthehospiceutilizetheseprocedureswhennecessaryL510(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(b(4))(iii)-Takeappropriatecorrectiveactioninaccordancewithstatelawiftheallegedviolationisverifiedbythehospiceadministrationoranoutsidebodyhavingjurisdiction,suchastheStatesurveyagencyorlocallawenforcementagency;andL511(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(b)(4)(iv)-EnsurethatverifiedviolationsarereportedtoStateandlocalbodieshavingjurisdiction(includingtotheStateSurveyandCertificationAgency)within5workingdaysofbecomingawareoftheviolation.
InterpretiveGuidelines§418.
52(b)(4)(iv)Thehospicehas5workingdaysfrombecomingawareoftheviolationtoinvestigateanyallegedviolationsand,iftheallegedviolationisverified,itmustreporttheverifiedviolationtotheStateandlocalbodieshavingjurisdictionwithinthose5days.
IfStaterequirementsforreportingverifiedviolationsaremorestringentthanFederalrequirements,themorestringentStaterequirementstakeprecedence.
ThestringentStaterequirementsmaybethosethatrequireviolationstobereportedregardlessofwhethertheyareverifiedornot,orrequirementsthatverifiedviolationsbereportedinlessthan5days.
However,ifStaterequirementsarelessstringentthanFederalrequirements,theFederalrequirementstakeprecedence.
L512(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)Standard:RightsofthepatientThepatienthasarighttothefollowing:(1)Receiveeffectivepainmanagementandsymptomcontrolfromthehospiceforconditionsrelatedtotheterminalillness;InterpretiveGuidelines§418.
52(c)(1)Hospicesareresponsibleformanagingthepatientspainandsymptomsrelatedtotheterminalillnessandrelatedconditionsinatimelyfashion.
Patientsshouldnothavetoexperiencelongwaitsforpainandsymptommanagement,medications,orinterventionstoaddressthepatientscondition.
Hospicesshouldhavemethodsinplacetoassurethatthepatientspain,andallotherdistressingsymptoms,arecontrolledeffectively24hoursaday/7daysperweek,inallsettingsandwhereverthepatientresides.
ProceduresandProbes§418.
52(c)(1)Askthehospicetodescribeitspolicyforassessing,managingandreassessingpainandothersymptomsandhowitdefineseffectivepainmanagementandsymptomcontrol.
Determinehowthehospiceassuresthatthepatientreceivestheneededmedicationsinatimelyfashion.
Duringthehomevisit,askpatient/familyhowquicklythehospicesatisfiesthepatientsrequestforpainmedicationorsymptomcontrol,duringthedaytimehours,nightsandweekends.
Observethepatientforanysignsofdiscomfort.
Askthepatientorfamily,asappropriate,ifthepatienthasbeenexperiencingpainorothersymptoms.
Ifso,wasthisreportedtothehospiceIfreported,whatwasthehospicesresponseHavetherebeenanyinstanceswherethehospicefailedtorespondpromptlytothepatientsrequestforpainmedicationorsymptommanagementL513(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)(2)-Beinvolvedindevelopinghisorherhospiceplanofcare;Probes§418.
52(c)(2)Askstaffhowtheyfacilitatepatient/familyparticipationinplanningcare.
Askthepatient/familyhowtheyareinvolvedinplanningcare.
L514(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)(3)-Refusecareortreatment;InterpretiveGuidelines§418.
52(c)(3)Whilepatientshavetherighttorefuseservices,probefurtherifyoufindaparticulartrendwhereamajorityorallpatientsarerefusingaparticularservice(e.
g.
,socialwork,spiritualcounseling,volunteers,etc.
,)toassurethatpatientsarefullyinformedoftheservicetheyarerefusingandthatthehospiceisfullypreparedtoprovidetheservicewithqualifiedpersonnel.
L515(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)(4)-Choosehisorherattendingphysician;InterpretiveGuidelines§418.
52(c)(4)Patientshavetherighttochoosetheirattendingphysicianandtohavethispersoninvolvedintheirmedicalcareinallhospicesettingsaslongastheattendingphysician,inturn,undertakestoprovidecareforthepatient.
Probe§418.
52(c)(4)Isthereanyevidencethatthehospicedoesnotallowpatientstochoosetheirattendingphysician,orpressuresthepatienttochoosethehospicephysicianastheirattendingphysicianL516(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)(5)-Haveaconfidentialclinicalrecord.
Accesstoorreleaseofpatientinformationandclinicalrecordsispermittedinaccordancewith45CFRParts160and164.
InterpretiveGuidelines§418.
52(c)(5)Therighttoconfidentialclinicalrecordsmeanssafeguardingthecontent,includingpaperrecordsand/orelectronicallystoredinformationfromunauthorizeddisclosurewithoutthespecificinformedconsentofthepatientorlegalrepresentative.
Thereshouldbeevidencethatthehospiceensurestheconfidentialityofthepatientsclinicalrecord.
Duringthesurvey,observewhetherclinicalstaffshowsevidenceofprotectingtheconfidentialityofclinicalrecords.
Ispatientinformationpostedwherevisitorsorothernon-hospicestaffcanviewitAreclinicalrecordsaccessibletounauthorizedpersonswhocouldreadorremovetheclinicalrecord,therebyviolatingthepatientsprivacyL517(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)(6)-Befreefrommistreatment,neglect,orverbal,mental,sexual,andphysicalabuse,includinginjuriesofunknownsource,andmisappropriationofpatientproperty;InterpretiveGuidelines§418.
52(c)(6)If,duringthecourseofthesurvey,youidentifythepossibilityofmistreatment,neglect,abuse(s),orinjuriesofunknownsourceandmisappropriationofpatientproperty,investigatethroughinterviews,observations,andrecordreviews.
FollowallapplicableFederalandStatesurveyguidelinesandpolicieswhenreportinganddocumentinganyinstanceswhereyouobserveviolationslistedinthisstandard.
Documentationshouldincludewhocommittedtheact,thenatureoftheact,andwhereandwhenitoccurred.
Ensurethatthehospiceaddressestheincident(s)immediately.
L518(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)(7)-Receiveinformationabouttheservicescoveredunderthehospicebenefit;InterpretiveGuidelines§418.
52(c)(7)Medicarecoveredhospiceservicesaresetforthat42CFR418.
200-204.
ThehospiceshouldfullyinformMedicarepatientsaboutallMedicarecoveredhospiceservicesandfullyinformnon-Medicarepatientsaboutanyotherhospiceservicesthatapplytothepatient(e.
g.
,Medicaid,privateinsurance).
ProceduresandProbes§418.
52(c)(7)Isthepatient/familyawareofallcoveredhospiceservicesincludingtheprovisionofmedicationsrelatedtotheterminalcondition,continuouscareandshort-terminpatientcareDiscusswhetherthehospicehasdescribedanyservicesforwhichthepatientmighthavetopay.
Considerthepatientsabilitytounderstandandretaincoverageinformation.
Ifthepatientcannotlocatetheinformationprovidedbythehospice,documentationintheclinicalrecordthatthehospicehasprovidedthisinformationtothepatient/familywillsuffice.
DoNOTtrytoadvisethepatientaboutfinancial,coverage,orpaymentissues.
L519(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
52(c)(8)-Receiveinformationaboutthescopeofservicesthatthehospicewillprovideandspecificlimitationsonthoseservices.
ProceduresandProbes§418.
52(c)(8)Askthepatient/familywhatservicestheyarereceivingfromthehospiceandiftheyareawareofanylimitationstothoseservices.
Hospicesarerequiredtoprovideallhospiceservicesnecessaryforthepalliationandmanagementoftheterminalillnessandrelatedconditionsandshouldnotacceptpatientsiftheycannotprovidethesehospiceservices.
See§418.
56(c).
Forexample,ahospicemaynotacceptapatientif,duetostaffingproblems,itisnotabletoprovidehospiceaideservicesintheamountneededtomeetthepatientsneeds.
L520(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54Conditionofparticipation:InitialandComprehensiveassessmentofthepatientL521§418.
54-Thehospicemustconductanddocumentinwritingapatient-specificcomprehensiveassessmentthatidentifiesthepatient'sneedforhospicecareandservices,andthepatient'sneedforphysical,psychosocial,emotional,andspiritualcare.
Thisassessmentincludesallareasofhospicecarerelatedtothepalliationandmanagementoftheterminalillnessandrelatedconditions.
InterpretiveGuidelines§418.
54Thecomprehensivepatientassessmentmustaccuratelyreflectthepatientscurrenthealthstatusandincludeinformationtoestablishandmonitoraplanofcare.
Hospicesarenotrequiredtousespecificformsorformatstodocumenttheirinitialorcomprehensiveassessments.
Theymaychoosetodocumentpatientspecificcomprehensiveassessmentsineitherwrittenorelectronicformatprovidedtheassessmentsarecomplete,readilyidentifiable,andavailableinthepatientsclinicalrecord.
L522(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(a)Standard:InitialassessmentThehospiceregisterednursemustcompleteaninitialassessmentwithin48hoursaftertheelectionofhospicecareinaccordancewith§418.
24iscomplete(unlessthephysician,patient,orrepresentativerequeststhattheinitialassessmentbecompletedinlessthan48hours.
)InterpretiveGuidelines§418.
54(a)Thepurposeoftheinitialassessmentistogatherthecriticalinformationnecessarytotreatthepatient/familysimmediatecareneeds.
Theassessmentneedstotakeplaceinthelocationwherehospiceservicesarebeingdelivered.
Theinitialassessmentisnota"meetandgreet"visitwherebythehospiceintroducesitselftothepatient/familyandbeginstoevaluatethepatientsinterestinandappropriatenessforhospicecare.
Itmustassessthepatientsimmediatephysical,psychosocial,emotionalandspiritualstatusrelatedtotheterminalillnessandrelatedconditions.
Theinitialassessmentisnecessarytogathertheessentialinformationnecessarytobegintheplanofcareandprovidetheimmediatenecessarycareandservices.
Theregisterednurse(RN)mustconductthisinitialassessment.
HospicesmaychoosetosendasocialworkerorotherdisciplinealongwiththeRNtocompletetheinitialassessment.
Hospicesarefreetochoosetheirownmethodfordocumentingtheinitialassessment.
ProceduresandProbes§418.
54(a)Determinethroughinterview,observationandrecordreviewifthehospiceidentifiedthepatient/familysimmediateneeds.
DidtheRNcompletetheinitialassessmentwithintherequiredtimeframesClinicalrecorddocumentationshouldconfirm/supportthattimeframesaremet.
Payparticularattentiontotheeffectivedate/timeoftheelectionandthedate/timeofthecompletionoftheinitialassessment.
L523(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(b)Standard:TimeframeforcompletionofthecomprehensiveassessmentThehospiceinterdisciplinarygroup,inconsultationwiththeindividual'sattendingphysician(ifany),mustcompletethecomprehensiveassessmentnolaterthan5calendardaysaftertheelectionofhospicecareinaccordancewith§418.
24.
InterpretiveGuidelines§418.
54(b)AllmembersoftheIDGmustbeinvolvedwithcompletingthecomprehensiveassessmentinordertoidentifythepatient/familysphysical,psychosocial,emotionalandspiritualneedsandcontributetothedevelopmentoftheplanofcaretoaddressthoseneeds.
Theindividuals/disciplinesthatcompletetheassessmentshouldbeconsistentwiththehospice'sownpoliciesandproceduresandthediscipline'sscopeofpractice.
TheRN,inconsultationwiththeothermembersoftheIDG,considerstheinformationgatheredfromtheinitialassessmentastheydeveloptheplanofcareandthegroupdetermineswhoshouldvisitthepatient/familyduringthefirst5daysofhospicecareinaccordancewithpatient/familyneedsanddesiresandthehospice'sownpoliciesandprocedures.
Thepatientmayormaynothaveanattendingphysician.
Iftheattendingphysicianisunavailableorunresponsive,thehospicephysicianmustassumethisrole.
Ifthepatientdoeshaveanattendingphysician,oneormoremembersoftheIDGshouldconsultwiththisphysicianincompletingthecomprehensiveassessment.
Thisconsultationcanoccurthroughphonecallsorothermeansofcommunication(Fax,e-mails,textmessages,etc.
,)andwillhelptoacquireabetterunderstandingofthepatientandfamily.
Attendingphysicianscanoftenprovideahistoryofthepatientsdiseaseprocessandfamilydynamicsthatcanhelpthehospicemakebettercareplanningdecisionsthataddressallareasofneedrelatedtotheterminalillnessandrelatedconditions,resultinginimprovedpatientoutcomes.
The"electionofhospicecare"istheeffectivedateoftheelectionstatement.
Thepatientmaysignthehospiceelectionstatementwithalater(notearlier)effectivedate.
Hospicesmaychoosetocompletethecomprehensiveassessmentearlierthan5daysaftertheeffectivedateoftheelection(e.
g.
,itmaycompletethecomprehensiveassessmentatthesametimetheinitialassessmentiscompleted).
L524(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)Standard:ContentofthecomprehensiveassessmentThecomprehensiveassessmentmustidentifythephysical,psychosocial,emotional,andspiritualneedsrelatedtotheterminalillnessthatmustbeaddressedinordertopromotethehospicepatient'swell-being,comfort,anddignitythroughoutthedyingprocess.
InterpretiveGuidelines§418.
54(c)Theassessmentwouldinclude,butnotbelimitedto,screeningforthefollowing:pain,dyspnea,nausea,vomiting,constipation,restlessness,anxiety,sleepdisorders,skinintegrity,confusion,emotionaldistress,spiritualneeds,supportsystems,andfamilyneedforcounselingandeducation.
Thehospicewouldthengatheradditionalinformation,asnecessary,tobeabletomeetthepatient/familyneeds.
Forexample,inadditiontoscreeningthepatientforthepresenceofpain,acomprehensiveassessmentofthepatientspainbasedonacceptedclinicalstandardsofpracticemaynecessitategatheringthefollowinginformation,asapplicabletothepatient:Historyofpainanditstreatment(includingnon-pharmacologicalandpharmacologicaltreatment);Characteristicsofpain,suchas:–Intensityofpain(e.
g.
,asmeasuredonastandardizedpainscale);–Descriptorsofpain(e.
g.
,burning,stabbing,tingling,aching);–Patternofpain(e.
g.
,constantorintermittent);–Locationandradiationofpain;–Frequency,timinganddurationofpain;–Impactofpainonqualityoflife(e.
g.
,sleeping,functioning,appetite,andmood);–Factorssuchasactivities,care,ortreatmentthatprecipitateorexacerbatepain;–Strategiesandfactorsthatreducepain;and–Additionalsymptomsassociatedwithpain(e.
g.
,nausea,anxiety).
Physicalexamination(mayincludethepainsite,thenervoussystem,mobilityandfunction,andphysical,psychologicalandcognitivestatus);Currentmedicalconditionsandmedications;andThepatient/familysgoalsforpainmanagementandtheirsatisfactionwiththecurrentlevelofpaincontrol.
L525(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)-Thecomprehensiveassessmentmusttakeintoconsiderationthefollowingfactors:(1)Thenatureandconditioncausingadmission(includingthepresenceorlackofobjectivedataandsubjectivecomplaints).
L526(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)(2)-Complicationsandriskfactorsthataffectcareplanning.
L527(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)(3)-Functionalstatus,includingthepatient'sabilitytounderstandandparticipateinhisorherowncare.
L528(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)(4)-Imminenceofdeath.
L529(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)(5)-Severityofsymptoms.
ProceduresandProbes§418.
54(c)(1)-(5)Askclinicalstafftodescribehowtheyobtainallrelevantinformationnecessarytocompletethecomprehensiveassessment.
Isthereevidenceintheclinicalrecordandduringhomevisitsthatthereasonsforadmission,complicationsandriskfactorsthatcouldaffectcareplanning,functionalstatus,imminenceofdeath,andsymptomseverityhavebeenidentifiedandarebeingaddressedL530(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)(6)-Drugprofile.
Areviewofallofthepatient'sprescriptionandover-the-counterdrugs,herbalremediesandotheralternativetreatmentsthatcouldaffectdrugtherapy.
Thisincludes,butisnotlimitedto,identificationofthefollowing:(i)Effectivenessofdrugtherapy(ii)Drugsideeffects(iii)Actualorpotentialdruginteractions(iv)Duplicatedrugtherapy(v)Drugtherapycurrentlyassociatedwithlaboratorymonitoring.
InterpretiveGuidelines§418.
54(c)(6)Inreviewingthepatientsprescribedandover-the-countermedicationsandanyadditionalsubstancethatcouldaffectdrugtherapy,thehospicemustconsiderdrugeffectiveness,sideeffects,interactionsofdrugs,duplicatedrugsanddrugsassociatedwithlaboratorytestingwhichcouldaffectthepatient.
Inaddition,thehospiceshouldconsiderboththeuseofpharmacologicalandnon-pharmacologicalinterventionstopromotethepatientscomfortlevelandsenseofwellbeingbasedontheassessmentofpatientneedsanddesires.
―MedicationInteraction‖istheimpactofanothersubstance(suchasanothermedication,nutritionalsupplement(includingherbalproducts),food,orsubstancesusedindiagnosticstudies)uponamedicationsaction.
Theinteractionsmayalterabsorption,distribution,metabolism,orelimination.
Theseinteractionsmaydecreasetheeffectivenessofthemedicationorincreasethepotentialforadverseconsequences.
―Duplicatetherapy"referstomultiplemedicationsofthesamepharmacologicalclass/categoryoranymedicationtherapythatsubstantiallyduplicatesaparticulareffectofanothermedicationthattheindividualistaking.
―Non-pharmacologicalinterventions‖referstoapproachestocarethatdonotinvolvemedications,generallydirectedtowardsstabilizingorimprovingapersonsmental,physicalorpsychosocialwellbeing.
Thereshouldbeevidenceintheclinicalrecordthatcommonsideeffectsofmedicationsareanticipatedandpreventivemeasuresareimplemented.
Thehospiceshouldrevieweachpatientsmedicationsandmonitorformedicationeffectiveness,actualorpotentialmedication-relatedeffects,duplicatedrugtherapyanduntowardinteractionsduringeachupdatetothecomprehensiveassessment,andasneededasnewmedicationsareaddedorchanged,orthepatientsconditionchanges.
ProceduresandProbes§418.
54(c)(6)Askclinicalstafftodescribetheirprocess/policyofdrugregimen/medicationreviewincluding:HowpotentialadverseeffectsanddrugreactionsareidentifiedWhatprocessisfollowedwhenapatient/familyisfoundtobenoncompliantWhatnon-pharmacologicalmethodsareconsideredtorelievepainandothersymptomsHowpatientsandfamiliesareeducatedabouteffectivepainandsymptommanagement.
Whatprocessthehospiceutilizestoassessandmeasurepainandotheruncomfortablesymptoms.
Whatproceduresorprotocolsthehospiceusestoreassesspainandsymptommanagement.
Howthehospicemonitorsapatientwhentheybeginanewmedication,increase/decreaseadosageordiscontinueamedication.
Duringthehomevisit,askthepatient/caregiverwhatmedications(prescriptionandover-the-counterdrugs,herbalremedies,etc.
)thepatientiscurrentlytakingandcomparethisinformationwiththemedicationsdocumentedwithintheplanofcare.
Arethepatientspreferences/goalsforpainmanagementandsymptomcontrolfollowedandachievedL531(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)(7)-Bereavement.
Aninitialbereavementassessmentoftheneedsofthepatient'sfamilyandotherindividualsfocusingonthesocial,spiritual,andculturalfactorsthatmayimpacttheirabilitytocopewiththepatient'sdeath.
Informationgatheredfromtheinitialbereavementassessmentmustbeincorporatedintotheplanofcareandconsideredinthebereavementplanofcare.
InterpretiveGuidelines§418.
54(c)(7)Althoughabereavementplanisinitiatedafterthedeathofthepatient,priortothedeath,thehospicemustassessanygrief/lossissuesofthepatientsfamilythroughaninitialbereavementriskassessmentthatisincorporatedintheplanofcare.
Bereavementissuescontinuetobepartoftheongoingassessments,andthebereavementplanofcareafterdeathisbasedonalltheseassessments.
Bereavementservicesmaybeofferedpriortothedeathwhentheinitialassessment,comprehensiveassessment,orupdatestotheassessmentidentifiestheneedforthepatient/family.
Social,spiritualandculturalfactorsthatmayimpactafamilymemberorotherindividualsabilitytocopewiththepatientsdeathwouldinclude,butnotbelimitedto:Historyofpreviouslosses;Familyproblems;Financialconcerns;Communicationissues;Drugandalcoholabuse;Healthconcerns;Legalandfinancialconcern;Mentalhealthissues;Presenceorabsenceofasupportsystem;andFeelingsofdespair,anger,guiltorabandonment.
Theseissuesmaynotbereadilyapparentduringtheinitialbereavementriskassessment,butshouldbeincorporatedintothehospiceplanofcareiftheybecomeevident,andmustbeconsideredinthebereavementplanofcare.
ProceduresandProbes§418.
54(c)(7)WhatevidenceispresentwhichshowsthatthehospiceconductedaninitialbereavementriskassessmentDoestheplanofcarereflect/addressthebereavementissuesidentifiedintheassessmentL532(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(c)(8)-Theneedforreferralsandfurtherevaluationbyappropriatehealthprofessionals.
ProceduresandProbes§418.
54(c)(8)Askthehospicehowtheydeterminetheneedtoreferapatientorfamilymember(s)toappropriatehealthprofessionalsforfurtherevaluation.
L533(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(d)Standard:UpdateofthecomprehensiveassessmentTheupdateofthecomprehensiveassessmentmustbeaccomplishedbythehospiceinterdisciplinarygroup(incollaborationwiththeindividual'sattendingphysician,ifany)andmustconsiderchangesthathavetakenplacesincetheinitialassessment.
Itmustincludeinformationonthepatient'sprogresstowarddesiredoutcomes,aswellasareassessmentofthepatient'sresponsetocare.
Theassessmentupdatemustbeaccomplishedasfrequentlyastheconditionofthepatientrequires,butnolessfrequentlythanevery15days.
InterpretiveGuidelines§418.
54(d)Hospicesarefreetochoosetheirownmethodfordocumentingupdatestotheassessment.
Thehospiceshouldevaluateanddocumentthepatientsresponsetothecare,treatmentandservicesprovided,andprogresstowarddesiredoutcomes.
ThepurposeofupdatingtheassessmentistoensurethatthehospiceIDGhasthemostrecentaccurateinformationaboutthepatient/familyinordertomakeaccuratecareplanningdecisions.
Assessmentupdatesshouldbeeasilyidentifiedintheclinicalrecord.
Hospicesarerequiredtoupdatethecomprehensiveassessmentasfrequentlyastheconditionofthepatientrequires,whichmaybemorefrequentlythanevery15days.
Thehospicemustensurethateachupdateiscompletednolaterthan15daysfromthepreviousone.
Hospicesarenotrequiredtocomplete,infull,thosedocumentsthattheyidentifiedascomprisingtheircomprehensiveassessmentevery15days,althoughhospicesarefreetodosoiftheysochoose.
Theyarerequiredtoidentifyanddocumentiftherewerenochangesinthepatient/familyconditionorneeds.
ThereshouldbeevidencethattheIDGidentifiesthroughitsongoingassessmentswhenachangeisneededtotheplanofcareandevidencethatthepatient/familyreceivesthecareandservicesnecessitatedbythechange.
ProceduresandProbes§418.
54(d)Determinethroughinterview,observationandrecordreviewifthereisevidencethatallmembersoftheIDGareactivelyinvolvedinevaluatingthepatientscare,sothatthepatientreceivesthebenefitofthefullIDGsassessment.
L534(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(e)Standard:Patientoutcomemeasures(1)Thecomprehensiveassessmentmustincludedataelementsthatallowformeasurementofoutcomes.
Thehospicemustmeasureanddocumentdatainthesamewayforallpatients.
Thedataelementsmusttakeintoconsiderationaspectsofcarerelatedtohospiceandpalliation.
InterpretiveGuidelines§418.
54(e)(1)Examplesofdataelementsthatwouldallowforthemeasurementofoutcomesinclude,butarenotlimitedto,patientreporteddataonoutcomesoftreatmentforpain,dyspnea,nausea,vomiting,constipation,emotionaldistress,andspiritualneeds.
Forexample,ahospicemaychoosetomeasurepatientswhosepainiscontrolledwithin48hoursofadmission.
Incorporatingadataelementintotheinitialassessmentandcomprehensiveassessmentwillidentifythepatientsthathadpainuponadmissionandidentifythepatientsthathadtheirpaincontrolledwithin48hours.
L535(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
54(e)(2)Thedataelementsmustbeanintegralpartofthecomprehensiveassessmentandmustbedocumentedinasystematicandretrievablewayforeachpatient.
Thedataelementsforeachpatientmustbeusedinindividualpatientcareplanningandinthecoordinationofservices,andmustbeusedintheaggregateforthehospice'squalityassessmentandperformanceimprovementprogram.
Procedures§418.
54(e)(2)Interviewkeystaffandhavethemexplainthehospicessystemofdocumentationandretrievalofpatientspecificdataelements.
Asktoseeacopyofthedataelementsthatcomprisethehospicescomprehensiveassessment.
Havethehospiceexplainhowtheyusethesedataelementsincareplanning,coordinationofservicesandintheirqualityassessmentandperformanceimprovement(QAPI)program.
L536(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56Conditionofparticipation:Interdisciplinarygroup,careplanning,andcoordinationofservicesL537(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56-Thehospicemustdesignateaninterdisciplinarygrouporgroupsasspecifiedinparagraph(a)ofthissectionwhich,inconsultationwiththepatient'sattendingphysician,mustprepareawrittenplanofcareforeachpatient.
InterpretiveGuidelines§418.
56ThephysicianmemberoftheIDGmaybethehospicemedicaldirectororanotherhospicephysicianwhoisemployedbyorundercontractwiththehospice.
Thenurse,socialworkerandcounselormembersoftheIDGmustbehospiceemployeesoremployeesoftheagencyororganizationofwhichthehospiceisasub-division(e.
g.
,ahospital)whoareappropriatelytrainedandassignedtothehospice.
Probes§418.
56AskthehospicehowitassuresthatawrittenplanofcareisdevelopedforeachpatientwithfullparticipationoftheIDGmembersinconsultationwiththepatientsattendingphysician,ifany.
RequestdocumentationthatverifiesthatallIDGmembersparticipatedineachpatient-specificwrittenplanofcare.
L538(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56-Theplanofcaremustspecifythehospicecareandservicesnecessarytomeetthepatientandfamily-specificneedsidentifiedinthecomprehensiveassessmentassuchneedsrelatetotheterminalillnessandrelatedconditions.
InterpretiveGuidelines§418.
56Thereshouldbeadirectlinkbetweentheneedsidentifiedinthepatient/familyassessmentandtheplanofcaredevelopedbythehospice.
Hospicesmayidentifyneedsinthecomprehensiveassessmentthatarenotrelatedtotheterminalillnessandrelatedconditions,andshoulddocumentthattheyareawareoftheseneedsandnotewhoisaddressingthem.
Hospicesarenotrequiredtoprovidedirectservicestomeetneedsunrelatedtotheterminalillness.
Hospicesareresponsibleforincludingservicesandtreatmentsintheplanofcarethataddresshowtheywillmeetthepatientandfamily-specificneedsrelatedtotheterminalillnessandrelatedconditions.
Themedicaldirectorand/orotherhospicephysicianisresponsibleformeetingthemedicalneedsofthepatientaccordingto§418.
64(a)(3)perthepatientsattendingphysiciansrequestorwhenthehospiceisunabletocontacttheattendingphysiciantoaddressthepatientsmedicalneeds.
L539(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(a)Standard:Approachtoservicedelivery(1)Thehospicemustdesignateaninterdisciplinarygrouporgroupscomposedofindividualswhoworktogethertomeetthephysical,medical,psychosocial,emotional,andspiritualneedsofthehospicepatientsandfamiliesfacingterminalillnessandbereavement.
Interdisciplinarygroupmembersmustprovidethecareandservicesofferedbythehospice,andthegroup,initsentirety,mustsupervisethecareandservices.
InterpretiveGuidelines§418.
56(a)(1)MembersoftheIDGmustbeappropriatelytrainedinthehospicephilosophyandcompetenttoperformintheirassignedarea(s).
ThehospicemayinvolveothermembersofthecareteamintheIDGsactivities.
―Supervision‖ofcarebytheIDGmembersmaybeaccomplishedbyface-to-faceortelephonicconferences,evaluations,discussionsandgeneraloversight,aswellasbydirectobservations.
Procedures§418.
56(a)(1)AsktheRNcoordinatortodescribethehospicessystemrelatedto:Developingandrevisingpatientcaregoals/objectives.
Facilitatingexchangeofinformationamongstaffandpatient/caregiver.
Developingamechanismwherebyacontinualflowofinformationregardingpatient/familyneedsaremadeavailabletotheIDGstaff.
L540(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(a)(1)-Thehospicemustdesignatearegisterednursethatisamemberoftheinterdisciplinarygrouptoprovidecoordinationofcareandtoensurecontinuousassessmentofeachpatient'sandfamily'sneedsandimplementationoftheinterdisciplinaryplanofcare.
ProceduresandProbes§418.
56(a)(1)Asktheadministratortoidentifytheindividual(s)designatedastheRNcoordinator(s).
Howdoesthispersonassurethatcoordinationofcareandcontinuousassessmentofneedsoccuramongstaffprovidingservicestothepatient/familysothatallmembersoftheIDGarekeptinformedofthepatient/familysstatusL541(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(a)(1)-Theinterdisciplinarygroupmustinclude,butisnotlimitedto,individualswhoarequalifiedandcompetenttopracticeinthefollowingprofessionalroles:(i)Adoctorofmedicineorosteopathy(whoisanemployeeorundercontractwiththehospice).
(ii)Aregisterednurse.
(iii)Asocialworker.
(iv)Apastoralorothercounselor.
InterpretiveGuidelines§418.
56(a)(1)(i)-(iv)ThenumberofindividualsontheIDGisnotasimportantastheirqualificationsandabilities.
Forexample,ifagroupmembermeetsthehospicecriteriaandislicensedasaregisterednurseandalsomeetstheMedicarecriteriatobeconsideredasocialworkerunderthehospicebenefit,he/shewouldbequalifiedtoserveontheIDGasbothanurseandasocialworker.
Procedures§418.
56(a)(1)(i)-(iv)Determinethroughinterview,observationandrecordreviewthatalldisciplinescomprisingtheIDGcontributetothepatientscomprehensiveandongoingassessmentsandcareplanningprocess.
L542(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(a)(2)-Ifthehospicehasmorethanoneinterdisciplinarygroup,itmustidentifyaspecificallydesignatedinterdisciplinarygrouptoestablishpoliciesgoverningtheday-to-dayprovisionofhospicecareandservices.
InterpretiveGuidelines§418.
56(a)(2)IfthehospicehasmorethanoneIDG,itmayselectmembersfromdifferentIDGstoserveontheIDGthatestablishesthehospicespolicies,aslongasallrequireddisciplinesarerepresented(e.
g.
,physician,RN,socialworker,counselor).
L543(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(b)Standard:PlanofcareAllhospicecareandservicesfurnishedtopatientsandtheirfamiliesmustfollowanindividualizedwrittenplanofcareestablishedbythehospiceinterdisciplinarygroupincollaborationwiththeattendingphysician(ifany),thepatientorrepresentative,andtheprimarycaregiverinaccordancewiththepatient'sneedsifanyofthemsodesire.
L544(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(b)-Thehospicemustensurethateachpatientandtheprimarycaregiver(s)receiveeducationandtrainingprovidedbythehospiceasappropriatetotheirresponsibilitiesforthecareandservicesidentifiedintheplanofcare.
L545(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(c)Standard:ContentoftheplanofcareThehospicemustdevelopanindividualizedwrittenplanofcareforeachpatient.
Theplanofcaremustreflectpatientandfamilygoalsandinterventionsbasedontheproblemsidentifiedintheinitial,comprehensive,andupdatedcomprehensiveassessments.
Theplanofcaremustincludeallservicesnecessaryforthepalliationandmanagementoftheterminalillnessandrelatedconditions,includingthefollowing:ProceduresandProbes§418.
56(c)Determinethroughinterview/observationandrecordreviewiftheplanofcareidentifiesalltheservicesneededtoaddressproblemsidentifiedintheinitial,comprehensiveandupdatedassessments.
Isthereevidenceofpatientsreceivingthemedication/treatmentsorderedAreplansofcareindividualizedandpatient-specificDoestheplanofcareintegratechangesbasedonassessmentfindingsIstheredocumentationtosupportthatthedevelopmentoftheplanofcarewasacollaborativeeffortinvolvingallmembersoftheIDGandtheattendingphysician,ifanyTheattendingphysicianandtheIDGmembersdonothavetosigntheplanofcarebuttheremustbedocumentationoftheirinvolvement.
L546(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(c)(1)-Interventionstomanagepainandsymptoms.
InterpretiveGuidelines§418.
56(c)(1)Thegoalofeffectivepainandsymptommanagementisqualityoflife.
Whenthepainandsymptomsthatcausedistresstothepatientareeffectivelymanaged,thepatientandfamilyarebetterabletofocusontheirvisionofa"gooddeath.
"Effectivepainandsymptommanagementincludetheongoingassessmentofthepatientsphysical,psychosocial,emotionalandspiritualneedsandre-evaluatingtheeffectivenessofthecurrentplanofcareinordertoaddressthoseneeds.
Thereshouldbeevidenceintheclinicalrecordandonhomevisitsthatthehospicetreatspatientssymptomssuchaspain,nausea,vomiting,dehydration,constipation,dyspnea,emotionaldistress,insomnia,neuropsychiatricsymptoms,andspiritualneedsusingacceptedprofessionalstandardsofpractice.
Thehospicemayalsoincludetheuseofalternativetherapiesintheplanofcare,tobenefithospicepatients/families(e.
g.
,art,yoga,massage,musicandlighttherapy).
ProceduresandProbes§418.
56(c)(1)Askclinicalmanagersandhospicestaffaboutspecificpatients,includinginformationaboutthepatientsconditionandwhatinterventionsarebeingusedtomanagepainandeasesymptoms.
Isthereevidencethehospiceproactivelyanticipatespotentialmedicationside-effectsandimplementspreventivemeasurestoaddressthemDuringhomevisits,observethepatientscomfortlevel.
Isthepatientsatisfiedwithhis/herlevelofcomfortAskthepatientorfamilyiftheyhaveeverhadtocallthehospicebecausethepatientspainorsymptomswereoutofcontrol.
Ifso,whatwasthehospicesresponseIftheinterventionsorcareprovideddonotappeartobeconsistentwithcurrentstandardsofpracticeand/orthepatientspainappearstopersistorrecur,interviewoneormorehealthcareprofessionalsasnecessary(e.
g.
,hospicenurse,physicianmemberoftheIDG)who,byvirtueoftrainingandknowledgeofthepatient,shouldbeabletoprovideinformationabouttheevaluationandmanagementofthepatientspain/symptoms.
Dependingontheissue,askabout:Howchoseninterventionsweredeterminedtobeappropriate;Howtheyguideandoverseetheselectionofpainmanagementinterventions;Therationalefornotintervening,ifpainwasidentifiedforwhichnointerventionwasimplemented;Changesinpaincharacteristicsthatmaywarrantrevieworrevisionofinterventions;andWhenandwithwhomtheprofessionaldiscussedtheeffectiveness,ineffectivenessandpossibleadverseconsequencesofpainmanagementinterventions.
L547(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(c)(2)-Adetailedstatementofthescopeandfrequencyofservicesnecessarytomeetthespecificpatientandfamilyneeds.
InterpretiveGuidelines§418.
56(c)(2)Theuseofvisitrangesinthepatientplanofcareshouldfollowtheseparameters:TheplanofcaremayincludearangeofvisitsandPRN(Latinabbreviationforprorenata-asneeded;ascircumstancesrequire)ordersforvisitfrequenciestoensurethemostappropriatelevelofserviceisprovidedtothepatient.
Arangeofvisitsisacceptableaslongasitcontinuestomeettheidentifiedneedsofthepatient/family.
Visitrangeswithsmallintervalsareacceptable(i.
e.
,1-3visits/week;2-4visits/week)butrangesthatinclude"0"asafrequencyarenotallowed.
TheIDGmayexceedthenumberofvisitsintherangetoaddresspatient/familysneeds.
Thereshouldbedocumentationintherecordtosupporttheneedfortheextravisit(s).
IfthepatientrequiresfrequentuseofPRNvisits,theplanofcareshouldbeupdatedtoincludetheneedforadditionalvisits.
Standingordersorroutineordersmustbeindividualizedtoaddressthespecificpatientsneedsandsignedbythepatientsphysician.
TheIDGshouldbeproactiveindevelopingeachpatientsplanofcarebyplanningaheadforanticipatedpatientchangesandneeds.
Decisionsshouldreflectthepatient/familypreferencesratherthanbesolelyaresponsetoacrisis.
ProceduresandProbes§418.
56(c)(2)AsktheclinicalmanagerandotherIDGmemberstodescribe:WhatcriteriaareusedtoassesstheneedsofthepatientandfamilyWhoisinvolvedinthisprocessHowtheIDGdecideswhatservicesthepatientwillreceiveHowthehospiceevaluatesiftheservicesprovidedarecontinuingtomeetthepatientsandfamiliesneedsHowthehospicemonitorsthedeliveryofservices,includingthoseprovidedunderarrangementorcontract,toensurecompliancewiththehospicephilosophyDuringthehomevisit,askthepatient/familyiftheyareawareofalltheservicesincludedinthehospicebenefit.
Iftheyarenotabletodescribethem,asktoseeanyinformation/documentationthehospicemayhaveleftwiththemdescribingtheseservices.
Askthepatient/familywhocomestoseethemfromthehospice,howoftentheycome,whatservicestheyprovideandiftheyareprovidedinatimelymanner.
AretheysatisfiedwiththelevelofservicestheyarereceivingDuringyourclinicalrecordreviewandhomevisit,determineifthereisanyindicationthepatientneedshospiceservicesthathe/sheisnotreceiving.
L548(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(c)(3)-Measurableoutcomesanticipatedfromimplementingandcoordinatingtheplanofcare.
InterpretiveGuidelines§418.
56(c)(3)Theoutcomesshouldbeameasurableresultoftheimplementationoftheplanofcare.
Thehospiceshouldbeusingdataelementsasapartoftheplanofcaretoseeiftheyaremeetingthegoalsofcare.
Probes§418.
56(c)(3)AretheoutcomesdocumentedandmeasurableLookformovementtowardstheexpectedoutcome(s)andrevisionstotheplanofcarethathavebeenmadetoachievetheoutcomes.
L549(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(c)(4)-Drugsandtreatmentnecessarytomeettheneedsofthepatient.
InterpretiveGuidelines§418.
56(c)(4)Seeguidanceat§418.
52(c)(1).
L550(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(c)(5)-Medicalsuppliesandappliancesnecessarytomeettheneedsofthepatient.
L551(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(c)(6)-Theinterdisciplinarygroup'sdocumentationofthepatient'sorrepresentative'slevelofunderstanding,involvement,andagreementwiththeplanofcare,inaccordancewiththehospice'sownpolicies,intheclinicalrecord.
InterpretiveGuidelines§418.
56(c)(6)Whilethepatient/familymustbeincludedindeveloping/updatingtheplanofcare,theydonotneedtobepresentduringIDGmeetings.
L552(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(d)Standard:ReviewoftheplanofcareThehospiceinterdisciplinarygroup(incollaborationwiththeindividual'sattendingphysician,ifany)mustreview,reviseanddocumenttheindividualizedplanasfrequentlyasthepatient'sconditionrequires,butnolessfrequentlythanevery15calendardays.
InterpretiveGuidelines§418.
56(d)Communicationwiththeattendingphysicianmaybethroughphonecalls,electronicmethods,ordersreceived,orothermeansaccordingtohospicepolicyandpatientneeds.
L553(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(d)-Arevisedplanofcaremustincludeinformationfromthepatient'supdatedcomprehensiveassessmentandmustnotethepatient'sprogresstowardoutcomesandgoalsspecifiedintheplanofcare.
ProceduresandProbes§418.
56(d)Askthehospicetodescribetheplanofcarereviewprocess.
HowdoesthehospiceIDG(incollaborationwiththeindividualsattendingphysician,ifany)ensurethateachpatientsindividualizedplanofcareisreviewed,andrevisedifwarranted,nolaterthan15daysfromthepreviousreviewL554(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(e)Standard:CoordinationofservicesThehospicemustdevelopandmaintainasystemofcommunicationandintegration,inaccordancewiththehospice'sownpoliciesandprocedures,to-(1)Ensurethattheinterdisciplinarygroupmaintainsresponsibilityfordirecting,coordinating,andsupervisingthecareandservicesprovided.
L555(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(e)(2)-Ensurethatthecareandservicesareprovidedinaccordancewiththeplanofcare.
L556(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(e)(3)-Ensurethatthecareandservicesprovidedarebasedonallassessmentsofthepatientandfamilyneeds.
L557(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(e)(4)-Provideforandensuretheongoingsharingofinformationbetweenalldisciplinesprovidingcareandservicesinallsettings,whetherthecareandservicesareprovideddirectlyorunderarrangement.
L558(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
56(e)(5)-Provideforanongoingsharingofinformationwithothernon-hospicehealthcareprovidersfurnishingservicesunrelatedtotheterminalillnessandrelatedconditions.
Probes§418.
56(e)(5)Whatsystemsareinplacetofacilitatetheexchangeofinformationandcoordinationofservicesamongstaffandwithothernon-hospicehealthcareprovidersHowdoesthehospiceensurethatcoordinationofcareoccursbetweenservicesprovideddirectlyandthoseunderarrangementIstheredocumentationintheclinicalrecordofthesharingofinformationbetweenalldisciplinesprovidingcareandwithotherhealthcareprovidersfurnishingservicestothepatientL559(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58Conditionofparticipation:QualityassessmentandperformanceimprovementL560(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58-Thehospicemustdevelop,implement,andmaintainaneffective,ongoing,hospice-widedata-drivenqualityassessmentandperformanceimprovementprogram.
Thehospice'sgoverningbodymustensurethattheprogram:reflectsthecomplexityofitsorganizationandservices;involvesallhospiceservices(includingthoseservicesfurnishedundercontractorarrangement);focusesonindicatorsrelatedtoimprovedpalliativeoutcomes;andtakesactionstodemonstrateimprovementinhospiceperformance.
ThehospicemustmaintaindocumentaryevidenceofitsqualityassessmentandperformanceimprovementprogramandbeabletodemonstrateitsoperationtoCMS.
InterpretiveGuidelines§418.
58TheconditionrequireseachhospicetodevelopitsownQAPIprogramtomeetitsneeds.
Hospiceoutcomemeasures,dataelements,tools,andinstructionsforusingthemhavebeendevelopedbythehospiceindustryandqualityimprovementorganizations.
Qualityimprovementinhospiceisadevelopingfield.
Themethodsusedbythehospiceforself-assessmentareflexibleandmayincludeareviewofcurrentdocumentation(e.
g.
,reviewofclinicalrecords,incidentreports,complaints,patientsatisfactionsurveys,etc.
);patientcare,directobservationofclinicalperformance,operatingsystemsandinterviewswithpatientsand/orstaff.
Theinformationgatheredbythehospiceshouldbebasedoncriteriaand/ormeasuresgeneratedbythemedicalandprofessional/technicalstaffsandreflecthospicebestpracticepatterns,staffperformance,andpatientoutcomes.
Ongoingmeansthatthereisacontinuousandperiodiccollectionandassessmentofdata.
Assessmentofsuchdataenablesareasofpotentialproblemstobeidentifiedandindicatesadditionaldatathatshouldbecollectedandassessedinordertoidentifywhetheraproblemexists.
ThefollowingelementsshouldbeconsideredwithintheQAPIplanhoweveritisstructured:Programobjectives;Allpatientcaredisciplines;Descriptionofhowtheprogramwillbeadministeredandcoordinated;Methodologyformonitoringandevaluatingthequalityofcare;Prioritiesforresolutionofproblems;Monitoringtodetermineeffectivenessofaction;Oversightresponsibilityreportstogoverningbody;andDocumentationofthereviewofitsownQAPIprogram.
ThefundamentalpurposeoftheQAPICoPistosetaclearexpectationthathospicesmusttakeaproactiveapproachtoimprovetheirperformance,andfocusonimprovedpatient/familycareandactivitiesthatimpactpatienthealthandsafety.
CMSstressestheimprovementinsystemsinordertoimproveprocessesandpatientoutcomes.
HospicesmusthaveallofthecomponentsofaQAPIprograminplacehospice-wide.
CMSexpectshospicestodemonstrate,withobjectivedata,thatimprovementshavetakenplaceinactualcareoutcomes,processesofcare,patient/familysatisfactionlevels,hospiceoperations,orotherperformanceindicators.
TheQAPIprogramwillbeevaluatedforitshospice-wideeffectivenessonthequalityofcareprovidedandactivitiesthatimpactuponpatienthealthandsafety.
Theimpactoftheprogramcanbeassessedbylookingatdatagatheredandcomparedatdifferentpointsintime,andactionstakenbasedonthatcomparison.
Thehospiceshouldbeanalyzingdataandevaluatingtheeffectivenessoftheirownprogramcontinually.
Theorganizedhospice-wideQAPIprogrammustbeongoingandhaveawrittenplanofimplementation.
Opportunitiestoimprovecareshouldbeappliedonahospice-widebasis,whenappropriate.
Thehospicetakesanddocumentsremedialactionwhenproblemsareidentifiedandevaluatestheoutcomeoftheseactions.
TheresultsmustbetransmittedtothegoverningbodytofulfillitsresponsibilitytoensureaneffectiveQAPIprogram.
Qualityassessmentandperformanceimprovementisaprocessofcontinualassessmentofahospicesperformancewithimplementationofsolutions,assessmentoftheeffectivenessofthesolutions,andevaluationstodeterminehowitcandoevenbetter.
TheQAPIprogramfostersthecontinualstrivingofimprovementofthedeliveryofcareandservicesprovidedbyahospice.
Performanceimprovementfostersa"blame-free"environmentandencourageshospicestoevaluatetheoperatingsystemsandprocessesintheagencyinsteadoffixingoneproblematatime.
ProceduresandProbes§418.
58Hospicesarerequiredtocollectandanalyzepatientcareandadministrativequalitydataandtousethatdatatoidentify,prioritize,implement,andevaluateperformanceimprovementprojectstoimprovethequalityofservicesfurnishedtohospicepatients.
InordertoassesscompliancewiththeQAPIrequirementsandtoassesstheadequacyandappropriatenessofahospicesQAPIprogram,requestthefollowing:Thehospicesaggregateddataanditsanalysisofthatdata;ThehospicesQAPIplan;TheindividualsresponsiblefortheQAPIprogram;EvidencethattheQAPIsystemhasbeenimplementedandisfunctioningeffectively,includingevidenceof:-Regularmeetings;-Investigationandanalysisofsentinelandadverseevents;-Recommendationsoroptionsforsystemicchangetopreventrecurrenceofsentineloradverseevents;-Identifiedperformancemeasuresthataretrackedandanalyzed;and-RegularreviewanduseoftheQAPIanalysesbyhospicemanagementandthegoverningbodytomakesystemicimprovements.
Anyothernecessaryresourcesneededtoassessahospicescompliance.
ThisinformationwillallowyoutomatchthedataprovidedbythehospicewiththeactualexperiencesofhospiceemployeesandpatientstoensurethattheQAPIprogramisprevalentthroughoutthehospicesoperationsandservices,andthatitispositivelyinfluencingpatientcare.
Focusonareassuchashowandwhythehospicechoseitsqualitymeasures,howitensuresconsistentdatacollection,howitusesdatainpatientcareplanning,andhowitaggregatesandanalyzesdata.
Askthehospicehowitusesthedataanalysistoselectperformanceimprovementprojects,howitimplementssuchprojects,andhowitusesthedatatoevaluatetheeffectivenessofthoseprojects.
WhileacopyofQAPImeetingminutesmaybeanacceptablemethodofdemonstratingthatregularmeetingswereheld,alternateevidencemaybeacceptable.
SurveyorsmaynotrequirecopiesofmeetingminutesunlessthemeetingminutesarejudgedtobeessentialtoanassessmentofwhethertheQAPIactuallyanalyzedanadverseorsentineleventthatisthesubjectofacomplaintinvestigationorstandardsurvey.
EssentialinthiscontextmeansthatthereisnotalternateevidencethatsufficestoaddressthecentralquestionofwhetheranassessmentthatmeetsCMSrequirementswasconducted.
Alternateevidence,forexample,maybearecommendationforsystemicchangethatwassufficientlydetailedthatareasonablepersonwouldconcludetherecommendationwasbasedoncompetentanalysis.
L561(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(a)Standard:Programscope(1)Theprogrammustatleastbecapableofshowingmeasurableimprovementinindicatorsrelatedtoimprovedpalliativeoutcomesandhospiceservices.
L562(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(a)(2)-Thehospicemustmeasure,analyze,andtrackqualityindicators,includingadversepatientevents,andotheraspectsofperformancethatenablethehospicetoassessprocessesofcare,hospiceservices,andoperations.
InterpretiveGuidelines§418.
58(a)(2)Hospicesarerequiredtoassessqualityinallareasofoperationsthatmightbeadverselyaffectingpatientcareorcorehospiceservices.
Thereisaspecificrequirementtotrackadverseevents(astheyaredefinedinhospicepolicy)andreducetheiroccurrencewherepossible.
Theymustbeabletoshow(usingquantitativedataorothermeans)thattheycanimprovequality,asmeasuredbytheirownindicatorsormeasures.
ProceduresandProbes§418.
58(a)(2)DoesthehospiceadheretoitsdefinitionofadverseeventwhentrackingandmonitoringandimplementingpreventiveactionsfortheseeventsDoesthehospicesQAPIprogrammeasure,analyzeandtrackqualityindicatorsrelatedtoprocessesofcare,hospiceservicesandoperationsL563(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(b)Standard:Programdata(1)Theprogrammustusequalityindicatordata,includingpatientcare,andotherrelevantdata,inthedesignofitsprogram.
InterpretiveGuidelines§418.
58(b)(1)HospicesmustnotlimittheirQAPIdatacollectioneffortstothedatacollectedduringpatientassessments.
Datacollectionmustlookbeyondpatientassessmentdatatoexamineallfacetsofahospicesoperation.
Allpatientservicesandallactivitiesthatmayimpactpatient/familycareshouldbeevaluatedaspartoftheQAPIprogram.
Thiswouldincludebutnotbelimitedto:physicianservices,nursingservices,medicalsocialservices,counselingservices,clinicalrecords,infectioncontrol,pharmaceuticalservices,durablemedicalequipment(DME),patientrights,administrativeservices,contractservices,volunteers,hospiceaideandadverseevents.
Whatevermeasuresthehospicechoosestoassessqualityshouldbemonitoredregularlysothatopportunitiesforimprovementcanbeidentifiedandprioritized.
Datashouldbecollectedinatimelymannersothatmeasurescanbereportedontheschedulesetupbythehospice.
ProceduresandProbes§418.
58(b)(1)IsthehospicesQAPIprogramdata-drivenIsthereevidencethatthehospiceusesthedatacollectedtoidentifyopportunitiesforimprovementL564(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(b(2)-Thehospicemustusethedatacollectedtodothefollowing:(i)Monitortheeffectivenessandsafetyofservicesandqualityofcare.
(ii)Identifyopportunitiesandprioritiesforimprovement.
L565(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(b(3)-Thefrequencyanddetailofthedatacollectionmustbeapprovedbythehospice'sgoverningbody.
InterpretiveGuidelines§418.
58(b)(3)Thegoverningbodymayassumehands-oncontroloftheQAPIprogramtoensurethattheprogramisincompliancewiththisrule,oritmaychoosetoappointoneormoreindividualstohandlethestructureandadministrationoftheQAPIprogram.
Thegoverningbodyretainsultimateresponsibilityfortheactionsofthedesignatedindividual(s).
L566(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(c)Standard:Programactivities(1)Thehospice'sperformanceimprovementactivitiesmust:(i)Focusonhighrisk,highvolume,orproblem-proneareas.
L567(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(c)(1)(ii)-Considerincidence,prevalence,andseverityofproblemsinthoseareas.
L568(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(c)(1)(iii)-Affectpalliativeoutcomes,patientsafety,andqualityofcare.
InterpretiveGuidelines§418.
58(c)(1)(iii)Outcomesaretheresultsofcareprovided;palliativeoutcomesaretheresultsofpalliativecareprovided.
L569(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(c)(2)-Performanceimprovementactivitiesmusttrackadversepatientevents,analyzetheircauses,andimplementpreventiveactionsandmechanismsthatincludefeedbackandlearningthroughoutthehospice.
InterpretiveGuidelines§418.
58(c)(2)Hospicesmaychoosetodeveloptheirowndefinitionfortheterm"adverseevent"oruseadefinitiondevelopedbyanationalaccreditingorganizationorindustryorganization.
Onceahospicehasidentifiedthedefinitionofanadverseevent,itisresponsibleforadheringtothedefinitionwhentrackingandanalyzingtheseeventsandwhenimplementingpreventiveactions.
Ingeneral,anadverseeventwouldbeanyactionorinactionbyahospicethatcausedharmtoahospicepatient.
However,hospicesarenotboundtousethisgenericdescription.
L570(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(c)(3)-Thehospicemusttakeactionsaimedatperformanceimprovementand,afterimplementingthoseactions,thehospicemustmeasureitssuccessandtrackperformancetoensurethatimprovementsaresustained.
InterpretiveGuidelines§418.
58(c)(3)Hospicesmustconsiderhowoftencertainqualityissuesariseandtheseverityofpotentialharmwhenprioritizingopportunitiesforimprovement.
Whenadverseeventmonitoringrevealsaproblemarea,thehospicemustimplementchangesdesignedtodecreaseoccurrenceoftheadverseevent.
Thehospicemustassurethatthenewprocessisimplementedhospice-wideandthatitiseffectiveinreducingtheadverseevent.
Forperformanceimprovementinallareasofoperations,thehospicemustmonitorthelevelofimprovementovertimetobesurethatitissustained.
ProceduresandProbes§418.
58(c)(3)DetermineifthehospicehastakenappropriateactiontocorrectproblemsidentifiedbytheQAPIprogram.
ExaminereportsandminutesofQAPImeetingstodetermineifthehospicehasdocumentedtheremedialactionanditsoutcome.
Examplesofappropriateremedialactionmayinclude,butarenotlimitedtochangesinpoliciesandprocedures.
IsthereevidencethatthehospicecontinuestomonitorperformancetoensurethatimprovementsaresustainedL571(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(d)Standard:PerformanceimprovementprojectsBeginningFebruary2,2009,hospicesmustdevelop,implementandevaluateperformanceimprovementprojects.
L572(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(d)(1)-Thenumberandscopeofdistinctperformanceimprovementprojectsconductedannually,basedontheneedsofthehospice'spopulationandinternalorganizationalneeds,mustreflectthescope,complexity,andpastperformanceofthehospice'sservicesandoperations.
L573(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(d)(2)-Thehospicemustdocumentwhatperformanceimprovementprojectsarebeingconducted,thereasonsforconductingtheseprojects,andthemeasurableprogressachievedontheseprojects.
InterpretiveGuidelines§418.
58(d)(2)Thereisnorequirementforhospicestoconductaspecificnumberofperformanceimprovementprojects.
TheymustselectthenumberandtopicsofprojectsbasedontheresultsoftheirqualitymonitoringandotherqualityinformationsuchastheresultsofStateoraccreditationsurveys.
Performanceimprovementprojectsmustbedocumentedinwrittenformandincludetheelementsoutlinedinthestandard.
ProceduresandProbes§418.
58(d)(2)Dothenumberandscopeofperformanceimprovementprojectsconductedbythehospiceaccuratelyreflectthescope,complexityandpastperformanceofthehospiceAreallperformanceimprovementprojectsappropriatelydocumentedL574(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(e)Standard:ExecutiveresponsibilitiesThehospice'sgoverningbodyisresponsibleforensuringthefollowing:(1)Thatanongoingprogramforqualityimprovementandpatientsafetyisdefined,implemented,andmaintained,andisevaluatedannually.
L575(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(e)(2)-Thatthehospice-widequalityassessmentandperformanceimprovementeffortsaddressprioritiesforimprovedqualityofcareandpatientsafety,andthatallimprovementactionsareevaluatedforeffectiveness.
L576(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
58(e)(3)-Thatoneormoreindividual(s)whoareresponsibleforoperatingthequalityassessmentandperformanceimprovementprogramaredesignated.
InterpretiveGuidelines§418.
58(e)(3)ThegoverningbodyisresponsibleforassuringthattheQAPIprogramisworkingtoaddressanyproblemareasinpatientcareandhospiceoperations,andtoimproveperformanceintheseareas.
ThegoverningbodymustalsoappointindividualswhowilloperatetheQAPIprogramforthehospice.
Probes§418.
58(e)(3)DohospicerecordsindicatethatthehospicesgoverningbodyisinvolvedinoversightoftheQAPIprogramIsthereanindividualappointedbythegoverningbodywhoisresponsibleforoperatingtheQAPIprogramL577(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
60Conditionofparticipation:InfectioncontrolL578(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
60-Thehospicemustmaintainanddocumentaneffectiveinfectioncontrolprogramthatprotectspatients,families,visitors,andhospicepersonnelbypreventingandcontrollinginfectionsandcommunicablediseases.
InterpretiveGuidelines§418.
60Thehospiceinfectioncontrolprogrammustidentifyrisksfortheacquisitionandtransmissionofinfectiousagentsinallsettingswherepatientsreside.
Thereneedstobeasystemtocommunicatewithallhospicepersonnel,patients,familiesandvisitorsaboutinfectionpreventionandcontrolissuesincludingtheirroleinpreventingthespreadofinfectionsandcommunicablediseasesthroughdailyactivities.
Thehospicesinfectioncontrolprogrammayinclude,butnotbelimitedtothefollowing:Educatingstaffonthescienceofinfectiousdiseasetransmission;Protocolsforaddressingpatientcareissuesandpreventionofinfectionrelatedtoinfusiontherapy,urinarytractcare,respiratorytractcare,andwoundcare;Guidelinesoncaringforpatientswithmulti-drugresistantorganism;Policiesonprotectingpatients,staffandfamiliesfrombloodborneorairbornepathogens;Monitoringstaffforcompliancewithhospicepoliciesandproceduresrelatedtoinfectioncontrol;andProtocolsforeducatingstaffandfamiliesinstandardprecautionsandthepreventionandcontrolofinfection.
ProceduresandProbes§418.
60Askthehospicewhatstepsittakestoassurethatstafftakeappropriateinfectionandcommunicablediseasepreventionandcontrolprecautions,includingeducatingthepatientandfamiliesabouttheirroleincommunicatingtheinformationtootherswhomayhavecontactwiththepatient.
Howdoesthehospiceensurethatpatients/familiesreceivetimelyinstructionregardingstandardprecautionstofollowinpreventingandcontrollinginfectionsandcommunicablediseasesIfthehospiceprovidesinpatientcaredirectly,observeforappropriateinfectionpreventionandcontrolprecautionsincludingsignageorotherpostedinformationormaterialsinpatientroomsorstaffareas.
L579(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
60(a)Standard:PreventionThehospicemustfollowacceptedstandardsofpracticetopreventthetransmissionofinfectionsandcommunicablediseases,includingtheuseofstandardprecautions.
InterpretiveGuidelines§418.
60(a)Acceptedstandardsofpracticeforhealthcareprovidersaretypicallydevelopedbygovernmentagencies,professionalorganizationsandassociations.
Exampleswouldinclude,butnotbelimitedto,theCentersforDiseaseControlandPrevention(CDC),theAgencyforHealthcareResearchandQuality,StatePracticeActs,andcommonlyacceptedhealthstandardsestablishedbynationalorganizations,boards,andcouncils(e.
g.
,AssociationforProfessionalsinInfectionControlandEpidemiology(APIC),AmericanNursesAssociationetc.
)StandardPrecautionsarebasedontheprinciplethatallblood,bodyfluids,secretions,excretions(exceptsweat),non-intactskin,andmucousmembranesmaycontaintransmissibleinfectiousagents.
StandardPrecautionsincludeagroupofinfectionpreventionpracticesthatapplytoallpatients,regardlessofsuspectedorconfirmedinfectionstatus,inanysettinginwhichhealthcareisdelivered.
Theseinclude:handhygiene;useofgloves,gown,mask,eyeprotection,orfaceshield,dependingontheanticipatedexposure;andsafeinjectionpractices.
Also,equipmentoritemsinthepatientenvironmentlikelytohavebeencontaminatedwithinfectiousbodyfluidsmustbehandledinamannertopreventtransmissionofinfectiousagents(e.
g.
,wearingglovesfordirectcontact,containheavilysoiledequipment,properlycleananddisinfectorsterilizereusableequipmentbeforeuseonanotherpatient).
(ExcerptfromCDC"GuidelineforIsolationPrecautions:PreventingTransmissionofInfectiousAgentsinHealthcareSettings2007.
")Anydeficiencycitedasaviolationofacceptedstandardsofpracticemusthaveacopyoftheapplicablestandardofpracticeprovidedtothehospicealongwiththestatementofdeficiencies.
AhospicemayalsobesurveyedforcompliancewithStatepracticeactsforeachrelevantdiscipline.
AnydeficiencycitedasaviolationofaStatepracticeactmustreferencetheapplicablesectionoftheStatepracticeactallegedlyviolated,andacopyofthatsectionoftheactmustbeprovidedtothehospicealongwiththestatementofdeficiencies.
Procedures§418.
60(a)Duringhomevisits,observethehospicespracticesrelatedtopreventionandtransmissionofinfectionsandcommunicablediseasesanduseofstandardprecautions.
L580(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
60(b)Standard:ControlThehospicemustmaintainacoordinatedagency-wideprogramforthesurveillance,identification,prevention,control,andinvestigationofinfectiousandcommunicablediseasesthat—(1)Isanintegralpartofthehospice'squalityassessmentandperformanceimprovementprogram;andInterpretiveGuidelines§418.
60(b)(1)Examplesofinfectioncontrolpracticesthatthehospicemayuseincludemonitoringworkrelatedemployeeillnessandinfections,analyzingtheminrelationtopatientinfections,andtakingappropriateactionswhenaninfectionorcommunicablediseaseispresenttopreventitsspreadamongstaff,patients,familyandvisitors.
Surveillancedatashouldberoutinelyreviewedandmonitored.
Appropriatecorrectiveactionsneedtobetakenbasedonthedataanalysis.
ThehospicemustusethisinformationasapartofitsQAPIprogram.
L581(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
60(b)(2)-Includesthefollowing:(i)Amethodofidentifyinginfectiousandcommunicablediseaseproblems;and(ii)Aplanforimplementingtheappropriateactionsthatareexpectedtoresultinimprovementanddiseaseprevention.
ProceduresandProbes§418.
60(b)(2)Askthehospicetoexplainthemethod(s)itusestoidentifyinfectiousandcommunicablediseaseproblems.
DoesthehospiceredesignitsstrategiestoimproveitsinfectionpreventionandcontrolpolicieswhenitidentifiesproblemsIfyouhaveconcerns,asktoreviewthehospicespoliciesrelatedtoinfectioncontrolandcommunicablediseases.
L582(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
60(c)Standard:EducationThehospicemustprovideinfectioncontroleducationtoemployees,contractedproviders,patients,andfamilymembersandothercaregivers.
Probes§418.
60(c)Ishospicestaff(directemployeesandcontactedstaff)awareofinfectioncontrolprinciplesandproceduresDotheydemonstratethisknowledgeduringhomevisitsDuringhomevisitsaskthepatient/familyorothercaregiverstodescribeinfectioncontroleducationtheyhavereceived.
L583(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
62Conditionofparticipation:Licensedprofessionalservices.
L584(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
62(a)-Licensedprofessionalservicesprovideddirectlyorunderarrangementmustbeauthorized,delivered,andsupervisedonlybyhealthcareprofessionalswhomeettheappropriatequalificationsspecifiedunder§418.
114andwhopracticeunderthehospice'spoliciesandprocedures.
InterpretiveGuidelines§418.
62(a)Licensedprofessionalservices,forpurposesofthissection,wouldinclude,butnotbelimitedto,skillednursingcare,physicaltherapy,speechlanguagepathology,occupationaltherapy,andmedicalsocialservices.
L585(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
62(b)-Licensedprofessionalsmustactivelyparticipateinthecoordinationofallaspectsofthepatient'shospicecare,inaccordancewithcurrentprofessionalstandardsandpractice,includingparticipatinginongoinginterdisciplinarycomprehensiveassessments,developingandevaluatingtheplanofcare,andcontributingtopatientandfamilycounselingandeducation;andL586(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
62(c)-Licensedprofessionalsmustparticipateinthehospice'squalityassessmentandperformanceimprovementprogramandhospicesponsoredin-servicetraining.
ProceduresandProbes§418.
62(c)InterviewkeystafftodeterminehowthehospiceensuresthatlicensedprofessionalsparticipateintheirQAPIandin-servicetrainingprograms.
Whatevidenceistherethatallemployees(directandcontracted)havebeenproperlyorientedtothetaskstheyareexpectedtoperform,participateintheappropriatehospicein-servicetrainingprograms,anddemonstratetheappropriateskills,whenneeded,inpracticeL587(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64Conditionofparticipation:CoreservicesL588(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64-Ahospicemustroutinelyprovidesubstantiallyallcoreservicesdirectlybyhospiceemployees.
Theseservicesmustbeprovidedinamannerconsistentwithacceptablestandardsofpractice.
Theseservicesincludenursingservices,medicalsocialservices,andcounseling.
Thehospicemaycontractforphysicianservicesasspecifiedinparagraph(a)ofthissection.
L589(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64-Ahospicemayusecontractedstaff,ifnecessary,tosupplementhospiceemployeesinordertomeettheneedsofpatientsunderextraordinaryorothernon-routinecircumstances.
AhospicemayalsoenterintoawrittenarrangementwithanotherMedicarecertifiedhospiceprogramfortheprovisionofcoreservicestosupplementhospiceemployee/stafftomeettheneedsofpatients.
Circumstancesunderwhichahospicemayenterintoawrittenarrangementfortheprovisionofcoreservicesinclude:unanticipatedperiodsofhighpatientloads,staffingshortagesduetoillnessorothershort-termtemporarysituationsthatinterruptpatientcare;andtemporarytravelofapatientoutsideofthehospice'sservicearea.
InterpretiveGuidelines§418.
64Employeemeansapersonwho:(1)worksforthehospiceandforwhomthehospiceisrequiredtoissueaW-2formonhisorherbehalf;or(2)ifthehospiceisasubdivisionofanagencyororganization,anemployeeoftheagencyororganizationwhoisassignedtothehospice;or(3)isavolunteerunderthejurisdictionofthehospice.
Ifacontractingserviceoragencypaystheindividual,andisrequiredtoissueaformW-2ontheindividualsbehalf,oriftheindividualisself-employed,theindividualisnotconsideredahospiceemployee.
Extraordinarycircumstancesgenerallywouldbeashort-termtemporaryeventthatwasunanticipated.
Examplesofsuchcircumstancesmightinclude,butarenotlimitedto,unanticipatedperiodsofhighpatientloads(suchasanunexpectedlylargenumberofpatientsrequiringcontinuouscaresimultaneously),staffingshortagesduetoillness,receivingpatientsevacuatedfromadisastersuchasahurricaneorawildfire,ortemporarytravelofapatientoutsidethehospicesservicearea.
IfahospicechoosestocontractwithanotherMedicare-certifiedhospiceoranon-hospiceentity,thecontractinghospicemustmaintainprofessionalmanagementresponsibilityfortheservicesprovided,inaccordancewith§418.
100(e).
Probes§418.
64HowdoesthehospiceassurethatallcontractprovidersreceivetraininginthehospicesphilosophyandcarebeforeprovidingservicestopatientsL590(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(a)Standard:PhysicianservicesThehospicemedicaldirector,physicianemployees,andcontractedphysician(s)ofthehospice,inconjunctionwiththepatient'sattendingphysician,areresponsibleforthepalliationandmanagementoftheterminalillnessandconditionsrelatedtotheterminalillness.
(1)Allphysicianemployeesandthoseundercontract,mustfunctionunderthesupervisionofthehospicemedicaldirector.
(2)Allphysicianemployeesandthoseundercontractshallmeetthisrequirementbyeitherprovidingtheservicesdirectlyorthroughcoordinatingpatientcarewiththeattendingphysician.
(3)Iftheattendingphysicianisunavailable,themedicaldirector,contractedphysician,and/orhospicephysicianemployeeisresponsibleformeetingthemedicalneedsofthepatient.
InterpretiveGuidelines§418.
64(a)ThemedicaldirectormayalsoserveasthephysicianmemberoftheIDG.
Probe§418.
64(a)IsthereevidencethatthemedicalneedsofthepatientsarebeingmetbythehospicephysicianforpatientswhodonothaveanattendingphysicianorwhentheattendingphysicianisunresponsiveorunavailableL591(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(b)Standard:Nursingservices(1)Thehospicemustprovidenursingcareandservicesbyorunderthesupervisionofaregisterednurse.
Nursingservicesmustensurethatthenursingneedsofthepatientaremetasidentifiedinthepatient'sinitialassessment,comprehensiveassessment,andupdatedassessments.
L592(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(b)(2)-IfStatelawpermitsregisterednursestosee,treat,andwriteordersforpatients,thenregisterednursesmayprovideservicestobeneficiariesreceivinghospicecare.
InterpretiveGuidelines§418.
64(b)(2)IfanR.
N.
,includinganursepractitioner,advancedpracticenurse,etc.
,ispermittedbyStatelawandregulationtosee,treat,andwriteorders,thentheR.
N.
mayperformthisfunctionwhileprovidingnursingservicesforhospicepatients.
Hospicesarefreetousetheservicesofalltypesofadvancedpracticenurseswithintheirrespectivescopesofpracticetoenhancethenursingcarefurnishedtoitspatients.
Servicesprovidedbyanursepractitioner(NP)whoisnotthepatientsattendingphysician,areincludedundernursingcare.
L593(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(b)(3)-Highlyspecializednursingservicesthatareprovidedsoinfrequentlythattheprovisionofsuchservicesbydirecthospiceemployeeswouldbeimpracticableandprohibitivelyexpensive,maybeprovidedundercontract.
InterpretiveGuidelines§418.
64(b)(3)Highlyspecializedservices,suchascomplexwoundcareandinfusionspecialties,aredeterminedbythenatureoftheserviceandthenursingskilllevelrequiredtobeproficientintheservice.
Forexample,ahospicemayneedtocontractwithapediatricnursebecauseoftheveryinfrequentpediatricpatientsthehospicecaresforandthattoemployeeapediatricnursewouldbeimpracticableandexpensive.
Continuouscareisnotahighlyspecializedservice,becausewhiletimeintensive,itdoesnotrequirehighlyspecializednursingskills.
L594(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(c)Standard:MedicalsocialservicesMedicalsocialservicesmustbeprovidedbyaqualifiedsocialworker,underthedirectionofaphysician.
Socialworkservicesmustbebasedonthepatient'spsychosocialassessmentandthepatient'sandfamily'sneedsandacceptanceoftheseservices.
InterpretiveGuidelines§418.
64(c)Thesocialworkersservicesareprovidedinaccordancewiththeplanofcare.
Becausesocialworkservicesmustbeprovidedunderthedirectionofaphysician,physicianapprovaloftheplanofcarewillsatisfytheintentofthisrequirement.
Thepsychosocialassessmentisanevolvingdocumentthatisrevisedasnewinformationisacquiredandasprogresstowardgoalsismade.
Thepsychosocialassessmentmayalsoincludethebereavementriskassessment.
ThepurposeofthepsychosocialassessmentistohelptheIDGidentifyissuesthateitherimpedeorfacilitatethepatientstreatmentandtoassistthepatient/familyinreachingthemaximumbenefitfromhospicecareandservices.
Theassessmentshouldincludeawidevarietyoffactors,includingbutnotlimitedto,thepatientandfamilysadjustmenttotheterminalillness,thesocialandemotionalfactorsrelatedtotheterminalillness,thepresenceorabsenceofadequatecopingmechanisms,thefamilydynamicsandcommunicationpatterns,financialresourcesorconstraints,thecaregiversabilitytofunctioneffectively,identifyingobstaclesandriskfactorswhichmayeffectcompliancewiththeplanofcare,andidentifyingfamilysupportsystemstohelpfacilitatecopingwithendoflifeissues.
ProceduresandProbes§418.
64(c)Howdoesthehospiceintroduceandoffermedicalsocialworkservicestothepatient/familyAskthesocialworkerorclinicalmanagertodescribethefactorsthatareincludedinthepsychosocialassessmentandhowthisinformationisusedinthecareplanningprocesstobenefitthepatient/family.
Isthereevidencethateachpatientreceivessocialworkservices(unlessspecificallyrefusedbythepatient)thatreflecttheneedsidentifiedinthepsychosocialassessmentL595(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(d)Standard:CounselingservicesCounselingservicesmustbeavailabletothepatientandfamilytoassistthepatientandfamilyinminimizingthestressandproblemsthatarisefromtheterminalillness,relatedconditions,andthedyingprocess.
L596(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(d)-Counselingservicesmustinclude,butarenotlimitedto,thefollowing:(1)-Bereavementcounseling.
Thehospicemust:(i)Haveanorganizedprogramfortheprovisionofbereavementservicesfurnishedunderthesupervisionofaqualifiedprofessionalwithexperienceoreducationingrieforlosscounseling.
(ii)Makebereavementservicesavailabletothefamilyandotherindividualsinthebereavementplanofcareupto1yearfollowingthedeathofthepatient.
BereavementcounselingalsoextendstoresidentsofaSNF/NForICF/MRwhenappropriateandidentifiedinthebereavementplanofcare.
(iii)Ensurethatbereavementservicesreflecttheneedsofthebereaved.
(iv)Developabereavementplanofcarethatnotesthekindofbereavementservicestobeofferedandthefrequencyofservicedelivery.
Aspecialcoverageprovisionforbereavementcounselingisspecifiedin§418.
204(c).
InterpretiveGuidelines§418.
64(d)(1)ThesupervisorofbereavementservicesmaybetheIDGsocialworkerorotherprofessionalwithdocumentedevidenceofexperienceoreducationingrieforlosscounseling.
ProceduresandProbes§418.
64(d)(1)Askthehospicetoexplainhowandwhentheyincorporatethebereavementassessmentintothecomprehensiveassessment.
WhatservicesdoesthehospiceprovidetoreflecttheneedsofthefamilyandotherindividualsinthebereavementplanofcareHowdoesthehospiceevaluatetheoutcomesandeffectivenessofthebereavementservicestheyprovideSelectandreviewasampleof2-3bereavementplansofcarefromalistofthepatientswhohavediedwithinthepast12months.
DetermineifthebereavementfollowupwasappropriateandprovidedwithinidentifiedtimeframesDidthebereavementservicesprovidedreflecttheneedsofthebereavedL597(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(d)(2)-Dietarycounseling.
Dietarycounseling,whenidentifiedintheplanofcare,mustbeperformedbyaqualifiedindividual,whichincludedietitiansaswellasnursesandotherindividualswhoareabletoaddressandassurethatthedietaryneedsofthepatientaremet.
InterpretiveGuidelines§418.
64(d)(2)Hospicesarerequiredtoassurethedietaryneedsofthepatientaremetbyaqualifiedindividual.
IfanRNiscapableofmeetingthepatientsneeds,thenthedietarycounselingcanbeprovidedbytheRN.
Iftheneedsofthepatientexceedtheexpertiseofthenurse,thenthehospicemusthaveavailableanappropriatelytrainedandqualifiedindividualsuchasaregistereddietitianornutritionisttomeetthepatientsdietaryneeds.
ProceduresandProbes§418.
64(d)(2)Asktheclinicalmanagerhowthehospicemeetstheneedsofpatientsandfamilieswhoexperiencechallengesandconflictwithendoflifecaredietaryissues.
Thismayincludeprovidingeducationabouthowthedyingprocessnaturallyresultsinlackofappetiteandintakeandhowthismayrelatetothepatientsdecreasingappetiteandfoodintolerancesduringtheendoflife.
Asktheclinicalmanagerhowthehospicemeetstheneedsofpatientswhoexperiencedysphasia,problematicenteralfeedings,orunresolvednutritionalissuessecondarytonausea,vomiting,orthedyingprocess.
L598(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
64(d)(3)-SpiritualcounselingThehospicemust:(i)Provideanassessmentofthepatient'sandfamily'sspiritualneeds.
(ii)Providespiritualcounselingtomeettheseneedsinaccordancewiththepatient'sandfamily'sacceptanceofthisservice,andinamannerconsistentwithpatientandfamilybeliefsanddesires.
(iii)Makeallreasonableeffortstofacilitatevisitsbylocalclergy,pastoralcounselors,orotherindividualswhocansupportthepatient'sspiritualneedstothebestofitsability.
(iv)Advisethepatientandfamilyofthisservice.
InterpretiveGuidelines§418.
64(d)(3)Thereshouldbeevidenceintheclinicalrecordthatthehospicehasofferedand/orprovidedspiritualcounselinginaccordancewiththepatient/familysdesires.
Ifapatientandfamilydesiresspiritualcounseling,thenahospiceshouldfacilitatevisitsbylocalclergy,pastoralcounselors,orotherstothebestofitsability.
ProceduresandProbes§418.
64(d)(3)Determinethroughclinicalrecordreview,interviewandhomevisitshowthehospiceaddressesthespiritualneeds/concernsofthepatientsandfamilies.
HowdoesthehospiceintroducetheavailabilityofspiritualcounselingWhatmechanismsareinplacetomeetthepatient/familyspiritualneedsL599(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
66Conditionofparticipation:Nursingservices--Waiverofrequirementthatsubstantiallyallnursingservicesberoutinelyprovideddirectlybyahospice.
L600(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
66(a)-CMSmaywaivetherequirementin§418.
64(b)thatahospiceprovidenursingservicesdirectly,ifthehospiceislocatedinanon-urbanizedarea.
Thelocationofahospicethatoperatesinseveralareasisconsideredtobethelocationofitscentraloffice.
ThehospicemustprovideevidencetoCMSthatithasmadeagoodfaithefforttohireasufficientnumberofnursestoprovideservices.
CMSmaywaivetherequirementthatnursingservicesbefurnishedbyemployeesbasedonthefollowingcriteria:1)Thelocationofthehospice'scentralofficeisinanon-urbanizedareaasdeterminedbytheBureauoftheCensus.
2)ThereisevidencethatahospicewasoperationalonorbeforeJanuary1,1983includingthefollowing:(i)ProofthattheorganizationwasestablishedtoprovidehospiceservicesonorbeforeJanuary1,1983.
(ii)Evidencethathospice-typeserviceswerefurnishedtopatientsonorbeforeJanuary1,1983.
(iii)Evidencethathospicecarewasadiscreteactivityratherthananaspectofanothertypeofprovider'spatientcareprogramonorbeforeJanuary1,1983.
3)Byvirtueofthefollowingevidencethatahospicemadeagoodfaithefforttohirenurses:(i)Copiesofadvertisementsinlocalnewspapersthatdemonstraterecruitmentefforts.
(ii)Jobdescriptionsfornurseemployees.
(iii)Evidencethatsalaryandbenefitsarecompetitiveforthearea.
(iv)Evidenceofanyotherrecruitingactivities(forexample,recruitingeffortsathealthfairsandcontactswithnursesatotherprovidersinthearea).
(a)Anywaiverrequestisdeemedtobegrantedunlessitisdeniedwithin60daysafteritisreceived.
(b)Waiverswillremaineffectivefor1yearatatimefromthedateoftherequest.
(c)Ifahospicewishestoreceivea1-yearextension,itmustsubmitarequesttoCMSbeforetheexpirationofthewaiverperiod,andcertifythattheconditionsunderwhichitoriginallyrequestedtheinitialwaiverhavenotchangedsincetheinitialwaiverwasgranted.
InterpretiveGuidelines§418.
66Section8161(dd)(5)(a)(i)oftheSocialSecurityActspecificallyreferencesurbanizedareasasdefinedbytheBureauoftheCensus.
Furtherinformationonthistopicisavailableathttp://www.
census/gov.
HospicesmayalsocontacttheirassignedMedicareadministrativecontractororcheckthehospicewageindex,whichisupdatedandpublishedyearly.
Ifthereisanyquestionconcerningawaiver,contacttheCMSRO.
L601(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
70Conditionofparticipation:Furnishingofnon-coreservices.
L602(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
70-Ahospicemustensurethattheservicesdescribedin§418.
72through§418.
78areprovideddirectlybythehospiceorunderarrangementsmadebythehospiceasspecifiedin§418.
100.
Theseservicesmustbeprovidedinamannerconsistentwithcurrentstandardsofpractice.
InterpretiveGuidelines§418.
70Thehospicemustensurethatallclinicalstaffmembers(directandcontractual)areawareofandfollowprofessionalpracticestandards,laws,hospicepolicies,andprocedures.
Ifquestionsariseduringhomevisitsorrecordreviews,askclinicalmanagersandstaffwhatthehospice'spoliciesareregardingtheissueinquestion.
Procedure§418.
70Askhowthehospicemonitorstheprofessionalskillsofitsstafftodetermineifthoseskillsareappropriateandadequateforitspatients.
L603(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
72Conditionofparticipation:Physicaltherapy,occupationaltherapy,andspeech-languagepathology.
L604(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
72-Physicaltherapyservices,occupationaltherapyservices,andspeech-languagepathologyservicesmustbeavailable,andwhenprovided,offeredinamannerconsistentwithacceptedstandardsofpractice.
InterpretiveGuidelines§418.
72Rehabilitativeservicessuchastrainingintheuseofadaptiveequipment,homesafetyassessment,andcaregiverinstructioninuseofgoodbodymechanicsforturningandliftingpatients,maybeappropriate/beneficialforthehospicepatient/family.
L605(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
74Waiverofrequirement-Physicaltherapy,occupationaltherapy,speech-languagepathology,anddietarycounseling.
L606(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
74(a)-Ahospicelocatedinanon-urbanizedareamaysubmitawrittenrequestforawaiveroftherequirementforprovidingphysicaltherapy,occupationaltherapy,speech-languagepathology,anddietarycounselingservices.
Thehospicemayseekawaiveroftherequirementthatitmakephysicaltherapy,occupationaltherapy,speech-languagepathology,anddietarycounselingservices(asneeded)availableona24-hourbasis.
Thehospicemayalsoseekawaiveroftherequirementthatitprovidedietarycounselingdirectly.
Thehospicemustprovideevidencethatithasmadeagoodfaithefforttomeettherequirementsfortheseservicesbeforeitseeksawaiver.
CMSmayapproveawaiverapplicationonthebasisofthefollowingcriteria:1)Thehospiceislocatedinanon-urbanizedareaasdeterminedbytheBureauoftheCensus.
2)Thehospiceprovidesevidencethatithadmadeagoodfaithefforttomakeavailablephysicaltherapy,occupationaltherapy,speech-languagepathology,anddietarycounselingservicesona24-hourbasisand/ortohireadietarycounselortofurnishservicesdirectly.
Thisevidencemustincludethefollowing:(i)Copiesofadvertisementsinlocalnewspapersthatdemonstraterecruitmentefforts.
(ii)Physicaltherapy,occupationaltherapy,speech-languagepathology,anddietarycounselorjobdescriptions.
(iii)Evidencethatsalaryandbenefitsarecompetitiveforthearea.
(iv)Evidenceofanyotherrecruitingactivities(forexample,recruitingeffortsathealthfairsandcontactdiscussionswithphysicaltherapy,occupationaltherapy,speech-languagepathology,anddietarycounselingserviceprovidersinthearea).
(a)Anywaiverrequestisdeemedtobegrantedunlessitisdeniedwithin60daysafteritisreceived.
(b)Aninitialwaiverwillremaineffectivefor1yearatatimefromthedateoftherequest.
(c)Ifahospicewishestoreceivea1-yearextension,itmustsubmitarequesttoCMSbeforetheexpirationofthewaiverperiodandcertifythatconditionsunderwhichitoriginallyrequestedthewaiverhavenotchangedsincetheinitialwaiverwasgranted.
InterpretiveGuidelines§418.
74Eligibilityforthiswaiver,aswiththenursingwaiver,isbasedontheprimarylocationofthehospice.
Ifthehospiceoperatesinmultiplelocations,theprimarylocationisconsideredtobelocationofthecentraloffice.
Thisofficemustbelocatedinanon-urbanizedareaasdeterminedbytheBureauofCensus.
ThiswaiverdoesnotwaivethehospicesresponsibilitytoprovidePT,OT,SLP,anddietarycounseling;onlytoprovidethem(asneeded)ona24-hourbasis.
Therearenolimitrestrictionstothenumberofextensionsahospicemayrequesttotheoriginalwaiverrequest.
L607(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76Conditionofparticipation:Hospiceaideandhomemakerservices.
L608(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76-Allhospiceaideservicesmustbeprovidedbyindividualswhomeetthepersonnelrequirementsspecifiedinparagraph(a)ofthissection.
Homemakerservicesmustbeprovidedbyindividualswhomeetthepersonnelrequirementsspecifiedinparagraph(j)ofthissection.
L609(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(a)Standard:Hospiceaidequalifications(1)Aqualifiedhospiceaideisapersonwhohassuccessfullycompletedoneofthefollowing:(i)Atrainingprogramandcompetencyevaluationasspecifiedinparagraphs(b)and(c)ofthissectionrespectively.
(ii)Acompetencyevaluationprogramthatmeetstherequirementsofparagraph(c)ofthissection.
(iii)AnurseaidetrainingandcompetencyevaluationprogramapprovedbytheStateasmeetingtherequirementsof§483.
151through§483.
154ofthischapter,andiscurrentlylistedingoodstandingontheStatenurseaideregistry.
(iv)AStatelicensureprogramthatmeetstherequirementsofparagraphs(b)and(c)ofthissection.
L610(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)(2)Ahospiceaideisnotconsideredtohavecompletedaprogram,asspecifiedinparagraph(a)(1)ofthissection,if,sincetheindividual'smostrecentcompletionoftheprogram(s),therehasbeenacontinuousperiodof24consecutivemonthsduringwhichnoneoftheservicesfurnishedbytheindividualasdescribedin§409.
40ofthischapterwereforcompensation.
Iftherehasbeena24-monthlapseinfurnishingservices,theindividualmustcompleteanotherprogram,asspecifiedinparagraph(a)(1)ofthissection,beforeprovidingservices.
L611(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(b)Standard:Contentanddurationofhospiceaideclassroomandsupervisedpracticaltraining.
(1)Hospiceaidetrainingmustincludeclassroomandsupervisedpracticaltraininginapracticumlaboratoryorothersettinginwhichthetraineedemonstratesknowledgewhileperformingtasksonanindividualunderthedirectsupervisionofaregisterednurse,oralicensedpracticalnurse,whoisunderthesupervisionofaregisterednurse.
Classroomandsupervisedpracticaltrainingcombinedmusttotalatleast75hours.
L612(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(b)(2)-Aminimumof16hoursofclassroomtrainingmustprecedeaminimumofl6hoursofsupervisedpracticaltrainingaspartofthe75hours.
L613(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(b)(3)-Ahospiceaidetrainingprogrammustaddresseachofthefollowingsubjectareas:(i)Communicationskills,includingtheabilitytoread,write,andverballyreportclinicalinformationtopatients,caregivers,andotherhospicestaff.
(ii)Observation,reporting,anddocumentationofpatientstatusandthecareorservicefurnished.
(iii)Readingandrecordingtemperature,pulse,andrespiration.
(iv)Basicinfectioncontrolprocedures.
(v)Basicelementsofbodyfunctioningandchangesinbodyfunctionthatmustbereportedtoanaide'ssupervisor.
(vi)Maintenanceofaclean,safe,andhealthyenvironment.
(vii)Recognizingemergenciesandtheknowledgeofemergencyproceduresandtheirapplication.
(viii)Thephysical,emotional,anddevelopmentalneedsofandwaystoworkwiththepopulationsservedbythehospice,includingtheneedforrespectforthepatient,hisorherprivacy,andhisorherproperty.
(ix)Appropriateandsafetechniquesinperformingpersonalhygieneandgroomingtasks,includingitemsonthefollowingbasicchecklist:(A)Bedbath.
(B)Sponge,tub,andshowerbath.
(C)Hairshampoo(sink,tub,andbed).
(D)Nailandskincare.
(E)Oralhygiene.
(F)Toiletingandelimination.
(x)Safetransfertechniquesandambulation.
(xi)Normalrangeofmotionandpositioning.
(xii)Adequatenutritionandfluidintake.
(xiii)Anyothertaskthatthehospicemaychoosetohaveanaideperform.
Thehospiceisresponsiblefortraininghospiceaides,asneeded,forskillsnotcoveredinthebasicchecklist,asdescribedinparagraph(b)(3)(ix)ofthissection.
L614(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(b)(4)-Thehospicemustmaintaindocumentationthatdemonstratesthattherequirementsofthisstandardaremet.
InterpretiveGuidelines§418.
76(b)(4)Ahospiceaidemayreceivetrainingfromdifferentorganizationsiftheamountoftrainingtotals75hours,thecontentoftrainingaddressesallsubjectslistedat§418.
76(b)(3)andtheorganization,training,instructors,anddocumentationmeettherequirementsoftheregulation.
Documentationoftrainingshouldinclude:Adescriptionofthetraining/competencyevaluationprogram,includingthequalificationsoftheinstructors;Arecordthatdistinguishesbetweenskillstaughtatapatientsbedsidewithsupervision,andthosetaughtinalaboratoryusingarealperson(notamannequin)andindicatorsofwhichskillseachaidewasjudgedtobecompetent;andHowadditionalskills(beyondthebasicskillslistedintheregulation)aretaughtandtestedifthehospicesadmissionpoliciesandcase-mixofhospicepatientsrequireaidestoperformmorecomplexprocedures.
L615(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(c)Standard:Competencyevaluation.
Anindividualmayfurnishhospiceaideservicesonbehalfofahospiceonlyafterthatindividualhassuccessfullycompletedacompetencyevaluationprogramasdescribedinthissection.
§418.
76(c)(1)-Thecompetencyevaluationmustaddresseachofthesubjectslistedinparagraph(b)(3)ofthissection.
Subjectareasspecifiedunderparagraphs(b)(3)(i),(b)(3)(iii),(b)(3)(ix),(b)(3)(x)and(b)(3)(xi)ofthissectionmustbeevaluatedbyobservinganaide'sperformanceofthetaskwithapatient.
Theremainingsubjectareasmaybeevaluatedthroughwrittenexamination,oralexamination,orafterobservationofahospiceaidewithapatient.
L616(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(c)(2)-Ahospiceaidecompetencyevaluationprogrammaybeofferedbyanyorganization,exceptasdescribedinparagraph(f)ofthissection.
InterpretiveGuidelines§418.
76(c)(1)–(2)Thehospicemustensurethattheskillslearnedortestedelsewherecanbetransferredsuccessfullytocareofthehospicepatientinallsettings.
Thehospiceshouldgivecarefulattentiontoevaluatingbothemployedaidesandthoseaideswhoprovideservicesunderarrangementorcontract.
Thisreviewofskillscouldbedonewhenthenurseinstallsanaideintoanewpatientcaresituationorduringasupervisoryvisit.
Amannequinmaynotbeusedforthisevaluation.
Ifthehospicesadmissionpoliciesandthecase-mixofpatientsdemandthattheaidecareforindividualswhoseneedsrequireadditionalcompetencybeyondtheminimumrequiredintheregulation,thehospicemustdocumenthowtheseadditionalskillsaretaughtandtested.
L617(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(c)(3)-Thecompetencyevaluationmustbeperformedbyaregisterednurseinconsultationwithotherskilledprofessionals,asappropriate.
L618(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(c)(4)-Ahospiceaideisnotconsideredcompetentinanytaskforwhichheorsheisevaluatedasunsatisfactory.
Anaidemustnotperformthattaskwithoutdirectsupervisionbyaregisterednurseuntilafterheorshehasreceivedtraininginthetaskforwhichheorshewasevaluatedas―unsatisfactory,‖andsuccessfullycompletesasubsequentevaluation.
Ahospiceaideisnotconsideredtohavesuccessfullycompletedacompetencyevaluationiftheaidehasan―unsatisfactory‖ratinginmorethanoneoftherequiredareas.
InterpretiveGuidelines§418.
76(c)(4)Ahospiceaidewhoisevaluatedassatisfactoryinallsubjectareasexceptonewouldbeconsideredcompetent.
However,thisaidewouldnotbeallowedtoperformthetaskinwhichheorshewasevaluatedasunsatisfactoryexceptunderdirectsupervision.
Ifahospiceaidereceivesanunsatisfactoryevaluationinmorethanonesubjectarea,theaidewouldnotbeconsideredtohavesuccessfullypassedacompetencyevaluationprogramandwouldbeprecludedfromfunctioningasahospiceaideinanysubjectarea.
Theregulationsplacenorestrictionsonthenumberoftimesorthetimeframeinwhichanaidecanbetestedinadeficientarea.
L619(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(c)(5)-Thehospicemustmaintaindocumentationthatdemonstratestherequirementsofthisstandardarebeingmet.
L620(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(d)Standard:In-servicetrainingAhospiceaidemustreceiveatleastl2hoursofin-servicetrainingduringeach12-monthperiod.
In-servicetrainingmayoccurwhileanaideisfurnishingcaretoapatient.
InterpretiveGuidelines§418.
76(d)Hospicesmayfulfilltheannual12-hourin-servicetrainingrequirementonacalendaryearbasis,anemploymentanniversarybasis,orarolling12monthbasisaslongaseachaidemeetsthisin-servicetrainingrequirement.
Hospiceaidein-servicetraining,thatoccurswithapatientinaplaceofresidence,supervisedbyanRN,canoccuraspartoftheevery14daysupervisoryvisit,buttheexactnewskillortheorytaughtmustbedocumented.
In-servicetrainingtaughtinthepatientsenvironmentshouldnotbearepetitionofabasicskill.
ProceduresandProbes§418.
76(d)Askhowthehospiceschedulestrainingtoassurethateveryaidereceivesatleast12hoursofin-servicetrainingwithineach12monthperiod.
L621(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(d)(1)-In-servicetrainingmaybeofferedbyanyorganization,andmustbesupervisedbyaregisterednurse.
L622(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(d)(2)-Thehospicemustmaintaindocumentationthatdemonstratestherequirementsofthisstandardaremet.
ProceduresandProbes§418.
76(d)(2)Reviewasampleof3-4hospiceaidetrainingfilestovalidatethataidesarereceivingtherequirednumberoftraininghours.
Ifconcernsarise,interviewtheaidesregardingin-servicetrainingsreceived.
L623(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(e)Standard:QualificationsforinstructorsconductingclassroomandsupervisedpracticaltrainingClassroomandsupervisedpracticaltrainingmustbeperformedbyaregisterednursewhopossessesaminimumof2yearsnursingexperience,atleast1yearofwhichmustbeinhomecare,orbyotherindividualsunderthegeneralsupervisionofaregisterednurse.
InterpretiveGuidelines§418.
76(e)Therequired2yearsofnursingexperiencefortheinstructorshouldbe"handson"clinicalexperiencesuchasprovidingcareand/orsupervisingnursingservicesorteachingnursingskillsinanorganizedcurriculumorin-serviceprogram.
Therequired2yearsofnursingexperiencemaybeinhomecareorinhospicecare.
"Otherindividuals"whomayhelpwithhospiceaidetrainingwouldincludehealthcareprofessionalssuchasphysicians,physicaltherapists,occupationaltherapists,medicalsocialworkers,andspeech-languagepathologists.
Nutritionists,pharmacists,lawyersandconsumersmightalsobeteachingresources.
L624(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(f)Standard:Eligiblecompetencyevaluationorganizations.
Ahospiceaidecompetencyevaluationprogramasspecifiedinparagraph(c)ofthissectionmaybeofferedbyanyorganizationexceptbyahomehealthagencythat,withintheprevious2years:(1)Hadbeenoutofcompliancewiththerequirementsof§484.
36(a)and§484.
36(b)ofthischapter.
(2)Permittedanindividualthatdoesnotmeetthedefinitionofa―qualifiedhomehealthaide‖asspecifiedin§484.
36(a)ofthischaptertofurnishhomehealthaideservices(withtheexceptionoflicensedhealthprofessionalsandvolunteers).
(3)Hadbeensubjectedtoanextended(orpartialextended)surveyasaresultofhavingbeenfoundtohavefurnishedsubstandardcare(orforotherreasonsatthediscretionofCMSortheState).
(4)Hadbeenassessedacivilmonetarypenaltyof$5,000ormoreasanintermediatesanction.
(5)HadbeenfoundbyCMStohavecompliancedeficienciesthatendangeredthehealthandsafetyofthehomehealthagency'spatientsandhadtemporarymanagementappointedtooverseethemanagementofthehomehealthagency.
(6)HadallorpartofitsMedicarepaymentssuspended.
(7)HadbeenfoundbyCMSortheStateunderanyFederalorstatelawtohave:(i)HaditsparticipationintheMedicareprogramterminated.
(ii)Beenassessedapenaltyof$5,000ormorefordeficienciesinFederalorStatestandardsforhomehealthagencies.
(iii)BeensubjectedtoasuspensionofMedicarepaymentstowhichitotherwisewouldhavebeenentitled.
(iv)Operatedundertemporarymanagementthatwasappointedbyagovernmentalauthoritytooverseetheoperationofthehomehealthagencyandtoensurethehealthandsafetyofthehomehealthagency'spatients.
(v)BeenclosedbyCMSortheState,orhaditspatientstransferredbytheState.
L625(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(g)Standard:Hospiceaideassignmentsandduties(1)Hospiceaidesareassignedtoaspecificpatientbyaregisterednursethatisamemberoftheinterdisciplinarygroup.
Writtenpatientcareinstructionsforahospiceaidemustbepreparedbyaregisterednursewhoisresponsibleforthesupervisionofahospiceaideasspecifiedunderparagraph(h)ofthissection.
InterpretiveGuidelines§418.
76(g)(1)Hospiceaidewritteninstructionsforpatientcarepreparedbytheregisterednurse(R.
N.
)responsibleforthesupervisionoftheaidemustbepatientspecificandnotgeneric.
ProceduresandProbes§418.
76(g)(1)Interviewkeystafftodeterminethefollowing:AreaidesdirectemployeesofthehospiceorprovidedbyarrangementIfservicesareprovidedunderarrangement,howdoesthehospiceensurethattheaidesprovidingpatientcarehavetheappropriatecompetencyskillsHowdoesthehospiceensurethataidesareproficienttocarryouttheirassignmentsinasafe,efficient,andeffectivemannerHowdoesthehospicemonitortheassignmentsofaidestomatchtheskillsneededforindividualpatientsIfyouhavequestionsthatariseasaresultofhomevisitsorrecordreviews,asktheclinicalmanagerstorespondtospecificissues.
L626(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(g)(2)-Ahospiceaideprovidesservicesthatare:(i)Orderedbytheinterdisciplinarygroup.
(ii)Includedintheplanofcare.
(iii)PermittedtobeperformedunderStatelawbysuchhospiceaide.
(iv)Consistentwiththehospiceaidetraining.
L627(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(g)(3)-Thedutiesofahospiceaideincludethefollowing:(i)Theprovisionofhands-onpersonalcare.
(ii)Theperformanceofsimpleproceduresasanextensionoftherapyornursingservices.
(iii)Assistanceinambulationorexercises.
(iv)Assistanceinadministeringmedicationsthatareordinarilyself-administered.
InterpretiveGuidelines§418.
76(g)(3)(iv)TheIDGdeterminesiftherearemedicationsthatareappropriateforaidestohelpadministerbasedontheneedsofthepatientandfamily,trainingandcompetencyoftheaide,policiesofthehospice,andanyapplicableStateandlocallawsandrules.
IfStateorlocallawsandrulesprohibithospiceaidesfromadministeringmedications,theyareprecludedfromdoingthisactivity.
However,ifmedicationadministrationiswithintheboundsofStateandlocallawsandrules,andifhospiceschoosetohaveaidesperformthistask,thehospiceisrequiredtoprovideaidetraininginmedicationadministrationandassurethattheaideiscompetenttoperformthistaskbeforehe/sheisassignedtothepatient.
Seealso§418.
76(b)(3)(xiii).
L628(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(g)(4)-Hospiceaidesmustreportchangesinthepatient'smedical,nursing,rehabilitative,andsocialneedstoaregisterednurse,asthechangesrelatetotheplanofcareandqualityassessmentandimprovementactivities.
Hospiceaidesmustalsocompleteappropriaterecordsincompliancewiththehospice'spoliciesandprocedures.
Procedures§418.
76(g)(4)Whenconductinghomevisitstopatientsreceivinghospiceaideservicesbeobservantforchangesinthepatientsmedical,nursing,rehabilitativeandsocialneedsthattheaideshouldbereportingtotheRN.
Throughclinicalrecordreviews,lookfordocumentationbytheaidedescribingchangesinthepatientsmedical,nursing,rehabilitativeandsocialneedsandtowhomheorshereportedtheinformation.
Clinicalnotationsshouldbedatedandsigned.
L629(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(h)Standard:Supervisionofhospiceaides.
(1)Aregisterednursemustmakeanon-sitevisittothepatient'shome:(i)Nolessfrequentlythanevery14daystoassessthequalityofcareandservicesprovidedbythehospiceaideandtoensurethatservicesorderedbythehospiceinterdisciplinarygroupmeetthepatient'sneeds.
Thehospiceaidedoesnothavetobepresentduringthisvisit.
InterpretiveGuidelines§418.
76(h)(1)(i)IftheRNmakesasupervisoryvisitonaTuesday,thenextsupervisoryvisitisduebytheTuesdaywhichoccurs14dayslater.
Inadditiontoensuringthathospiceaidesfurnishthecareidentifiedintheplanofcare,RNsupervisorsmustassesstheadequacyoftheaideservicesinrelationshiptotheneedsofthepatientandfamily.
In-personvisitsbythesupervisingnursetothepatientshomeallowthenursetodirectlyobservethepatientandtheresultsoftheaidescare.
Thesupervisoryvisitsmustbedocumentedinthepatientsclinicalrecord.
L630(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(h)(1)(ii)-Ifanareaofconcernisnotedbythesupervisingnurse,thenthehospicemustmakeanon-sitevisittothelocationwherethepatientisreceivingcareinordertoobserveandassesstheaidewhileheorsheisperformingcare.
InterpretiveGuidelines§418.
76(h)(1)(ii)ThesupervisingRNmustconductanin-personsupervisoryvisitwiththeaidetoobserveandassessaideskillsifapotentialdeficiencyincarefurnishedbytheaideisnotedintheregular14-daysupervisoryvisit(duringwhichtheaideisnotrequiredtobepresent).
L631(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(h)(1)(iii)-Ifanareaofconcernisverifiedbythehospiceduringtheon-sitevisit,thenthehospicemustconduct,andthehospiceaidemustcomplete,acompetencyevaluationinaccordancewith§418.
76(c).
L632(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(h)(2)-Aregisterednursemustmakeanannualon-sitevisittothelocationwhereapatientisreceivingcareinordertoobserveandassesseachaidewhileheorsheisperformingcare.
InterpretiveGuidelines§418.
76(h)(2)Theannualon-sitesupervisionvisitistoassessandobserveeachaideprovidingcaretooneofthepatients.
Thereisnorequirementfortheobservationvisittobeconductedoneachpatienttheaideiscaringfor.
Hospicesmaydeterminetheappropriatelocationtodocumenttheannualaideon-siteevaluationinaccordancewiththeirownpoliciesandprocedures.
ProceduresandProbes§418.
76(h)(2)Interviewkeystafftodeterminehowthehospiceassuresthatallaidesaresupervisedon-siteannually.
L633(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(h)(3)-Thesupervisingnursemustassessanaide'sabilitytodemonstrateinitialandcontinuedsatisfactoryperformanceinmeetingoutcomecriteriathatinclude,butisnotlimitedto–(i)Followingthepatient'splanofcareforcompletionoftasksassignedtothehospiceaidebytheregisterednurse.
(ii)Creatingsuccessfulinterpersonalrelationshipswiththepatientandfamily.
(iii)Demonstratingcompetencywithassignedtasks.
(iv)Complyingwithinfectioncontrolpoliciesandprocedures.
(v)Reportingchangesinthepatient'scondition.
InterpretiveGuidelines§418.
76(h)(3)Supervisoryvisitsmaybemadeinconjunctionwithaprofessionalvisittoprovideservices.
DocumentationofRNsupervisionshouldinclude,butnotbelimitedto,iftheaideisfollowingtheplanofcare,iscompetentinperformingrequiredtasksandissatisfactorytothepatient/family.
L634(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(i)Standard:IndividualsfurnishingMedicaidpersonalcareaide-onlyservicesunderaMedicaidpersonalcarebenefitAnindividualmayfurnishpersonalcareservices,asdefinedin§440.
167ofthischapter,onbehalfofahospiceagency.
§418.
76(i)(1)-Beforetheindividualmayfurnishpersonalcareservices,theindividualmustbefoundcompetentbytheState(ifregulatedbytheState)tofurnishthoseservices.
Theindividualonlyneedstodemonstratecompetencyintheservicestheindividualisrequiredtofurnish.
L635(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(i)(2)-ServicesundertheMedicaidpersonalcarebenefitmaybeusedtotheextentthatthehospicewouldroutinelyusetheservicesofahospicepatient'sfamilyinimplementingapatient'splanofcare.
L636(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(i)(3)-ThehospicemustcoordinateitshospiceaideandhomemakerserviceswiththeMedicaidpersonalcarebenefittoensurethepatientreceivesthehospiceaideandhomemakerservicesheorsheneeds.
InterpretiveGuidelines§418.
76(i)(3)ItisuptotheStatetodefinetheoptionalMedicaidStatePlanpersonalcareservicesbenefitandtodetermineifthebenefitismoreextensivethanthehomemaker/hospiceaidebenefitprovidedundertheMedicarehospicebenefit.
IftheMedicaidpersonalcareservicesbenefitismoreextensivethanwhatisofferedundertheMedicarehospicebenefit,propercoordinationofservicesmustoccur.
Inthisinstance,theStatemustpayforcoveredMedicaidpersonalcareservicesthatexceedthescopeoftheMedicarehospicebenefitwhenaneedforthosepersonalcareservicesisindicatedinthepatientshospiceplanofcare.
L637(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(j)Standard:Homemakerqualifications.
Aqualifiedhomemakeris—(1)Anindividualwhomeetsthestandardsin§418.
202(g)andhassuccessfullycompletedhospiceorientationaddressingtheneedsandconcernsofpatientsandfamiliescopingwithaterminalillness;or(2)Ahospiceaideasdescribedin§418.
76.
InterpretiveGuidelines§418.
76(j)Homemakerservicesmayincludeassistanceinmaintainingasafeandhealthyenvironmentforthepatient/familyandservicestohelpthepatient/familycarryoutthetreatmentplan.
See§418.
202(g).
L638(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(k)Standard:Homemakersupervisionandduties.
(1)Homemakerservicesmustbecoordinatedandsupervisedbyamemberoftheinterdisciplinarygroup.
L639(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(k)(2)Instructionsforhomemakerdutiesmustbepreparedbyamemberoftheinterdisciplinarygroup.
L640(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
76(k)(3)Homemakersmustreportallconcernsaboutthepatientorfamilytothememberoftheinterdisciplinarygroupwhoiscoordinatinghomemakerservices.
ProceduresandProbes§418.
76(k)Interviewkeyadministrativestaffregardingwhichmember(s)oftheIDGisresponsibleforthecoordinationandsupervisionofhomemakerservices.
Throughinterview,homevisitsandrecordreviewsassurethattherearewritteninstructionsfordutiestobeperformedandthatanypatientandfamilyconcernsarebeingreportedtothehomemakerservicescoordinator.
Thedutiesofthehomemakerandtheservicesperformedmustbedocumentedintheclinicalrecord.
L641(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
78Conditionsofparticipation–Volunteers.
L642(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
78-Thehospicemustusevolunteerstotheextentspecifiedinparagraph(e)ofthissection.
Thesevolunteersmustbeusedindefinedrolesandunderthesupervisionofadesignatedhospiceemployee.
InterpretiveGuidelines§418.
78Volunteersareconsideredhospiceemployeestofacilitatecompliancewiththecoreservicesrequirement.
ProceduresandProbes§418.
78Conductaninterviewwiththeindividualdesignatedtosupervisethevolunteersregardingtheuse,training,andsupervisionofvolunteers.
L643(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
78(a)Standard:Training.
Thehospicemustmaintain,documentandprovidevolunteerorientationandtrainingthatisconsistentwithhospiceindustrystandards.
InterpretiveGuidelines§418.
78(a)Allrequiredvolunteertrainingshouldbeconsistentwiththespecifictasksthatvolunteersperform.
Probes§418.
78(a)HowdoesthehospicesupervisethevolunteersIsthereevidencethatallvolunteersreceivethesupervisionnecessarytoperformtheirassignmentsIstheredocumentationsupportingthatallthevolunteershavereceivedtrainingororientationbeforebeingassignedtoapatient/familyWhatevidenceistherethatthevolunteersareawareof:Theirdutiesandresponsibilities;Theperson(s)towhomtheyreport;Theperson(s)tocontactiftheyneedassistanceandinstructionsregardingtheperformanceoftheirdutiesandresponsibilities;Hospicegoals,servicesandphilosophy;Confidentialityandprotectionofthepatientsandfamilysrights;Familydynamics,copingmechanismsandpsychologicalissuessurroundingterminalillness,deathandbereavement;Procedurestobefollowedinanemergency,orfollowingthedeathofthepatient;andGuidancerelatedspecificallytoindividualresponsibilities.
L644(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
78(b)Standard:RoleVolunteersmustbeusedinday-to-dayadministrativeand/ordirectpatientcareroles.
InterpretiveGuidelines§418.
78(b)Qualifiedvolunteerswhoprovideprofessionalservicesforthehospicemustmeetallrequirementsassociatedwiththeirspecialtyarea.
IflicensureorregistrationisrequiredbytheState,thevolunteermustbelicensedorregistered.
Thehospicemayusevolunteerstoprovideassistanceinthehospicesancillaryandofficeactivitiesaswellasindirectpatientcareservices,and/orhelppatientsandfamilieswithhouseholdchores,shopping,transportation,andcompanionship.
Hospicesarealsopermittedtousevolunteersinnon-administrativeandnon-directpatientcareactivities,althoughtheseservicesarenotconsideredwhencalculatingthelevelofactivitydescibedinstandard(e).
Thedutiesofvolunteersusedindirectpatientcareservicesorhelpingpatientsandfamiliesmustbeevidentinthepatientsplanofcare.
Thereshouldbedocumentationoftimespentandtheservicesprovidedbyvolunteers.
Probes§418.
78(b)WhatevidenceexiststhattheIDGconductsanassessmentofthepatient/familysneedforavolunteerL645(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
78(c)Standard:Recruitingandretaining.
Thehospicemustdocumentanddemonstrateviableandongoingeffortstorecruitandretainvolunteers.
L646(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
78(d)Standard:CostsavingThehospicemustdocumentthecostsavingsachievedthroughtheuseofvolunteers.
Documentationmustincludethefollowing:(1)Theidentificationofeachpositionthatisoccupiedbyavolunteer.
(2)Theworktimespentbyvolunteersoccupyingthosepositions.
(3)Estimatesofthedollarcoststhatthehospicewouldhaveincurredifpaidemployeesoccupiedthepositionsidentifiedinparagraph(d)(1)ofthissectionfortheamountoftimespecifiedinparagraph(d)(2)ofthissection.
InterpretiveGuidelines§418.
78(d)Thereisnorequirementforwhatthecostsavingsmustbe,onlyonhowitiscomputed.
L647(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
78(e)Standard:Levelofactivity.
Volunteersmustprovideday-to-dayadministrativeand/ordirectpatientcareservicesinanamountthat,ataminimum,equals5percentofthetotalpatientcarehoursofallpaidhospiceemployeesandcontractstaff.
Thehospicemustmaintainrecordsontheuseofvolunteersforpatientcareandadministrativeservices,includingthetypeofservicesandtimeworked.
InterpretiveGuidelines§418.
78(e)Incomputingthislevelofactivity,thehospicedividesthenumberofhoursthathospicevolunteersspentprovidingadministrativeand/ordirectpatientcareservicesbythetotalnumberofpatientcarehoursofallpaidhospiceemployeesandcontractstaff.
Forexample,ifthehospiceprovides10,000hoursofpaiddirectpatientcareduringaone-yearperiodthehospicemustprovide500volunteerhoursindirectpatientcareoradministrativeactivitiestomeettherequired5percenttotal.
Ahospicemayfluctuatethevolumeofcareprovidedbyvolunteersafterthehospicemeetstherequired5percentminimum.
L648(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100ConditionofParticipation:Organizationandadministrationofservices.
L649(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100-Thehospicemustorganize,manage,andadministeritsresourcestoprovidethehospicecareandservicestopatients,caregiversandfamiliesnecessaryforthepalliationandmanagementoftheterminalillnessandrelatedconditions.
L650(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(a)Standard:Servingthehospicepatientandfamily.
Thehospicemustprovidehospicecarethat-(1)Optimizescomfortanddignity;and(2)Isconsistentwithpatientandfamilyneedsandgoals,withpatientneedsandgoalsaspriority.
L651(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(b)Standard:Governingbodyandadministrator.
Agoverningbody(ordesignatedpersonssofunctioning)assumesfulllegalauthorityandresponsibilityforthemanagementofthehospice,theprovisionofallhospiceservices,itsfiscaloperations,andcontinuousqualityassessmentandperformanceimprovement.
Aqualifiedadministratorappointedbyandreportingtothegoverningbodyisresponsiblefortheday-to-dayoperationofthehospice.
Theadministratormustbeahospiceemployeeandpossesseducationandexperiencerequiredbythehospice'sgoverningbody.
InterpretiveGuidelines§418.
100(b)Ifthehospiceispartofalargerorganization(e.
g.
,HHA,hospital)andthegoverningbodyisthesame,theremustbedocumentedevidencethatthegoverningbodyisassumingfullauthorityandresponsibilityforthemanagementofthehospiceandreviewsandaddressesthefunctioningofspecifichospiceoperations,servicesandQAPIprogram.
Iftheadministratorisnotavailabletofulfillhisorherassigneddutiesandresponsibilities,thehospicemustidentifyanotherindividualtoassumethoseassigneddutiesandresponsibilitiesinaccordancewiththehospicesestablishedpoliciesandprocedures.
Thegoverningbodymustassumeresponsibilityforensuringthatthehospiceismanagedbytheadministratorandanymanagersthattheadministratorappoints.
ProceduresandProbes§418.
100(b)Howisthegoverningbodyinformedofthehospicesongoingoperations,includingpatientcaredeliveryissuesandqualityassessmentandperformanceimprovementactivitiesAsktheadministratororclinicalsupervisortodescribetherelationshipbetweenthegoverningbody,hospicemanagementandstaff.
L652(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(c)Standard:Services.
(1)Ahospicemustbeprimarilyengagedinprovidingthefollowingcareandservicesandmustdosoinamannerthatisconsistentwithacceptedstandardsofpractice:(i)Nursingservices.
(ii)Medicalsocialservices.
(iii)Physicianservices.
(iv)Counselingservices,includingspiritualcounseling,dietarycounseling,andbereavementcounseling.
(v)Hospiceaide,volunteer,andhomemakerservices.
(vi)Physicaltherapy,occupationaltherapy,andspeech-languagepathologyservices.
(vii)Short-terminpatientcare.
(viii)Medicalsupplies(includingdrugsandbiologicals)andmedicalappliances.
L653(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(c)(2)-Nursingservices,physicianservices,anddrugsandbiologicals(asspecifiedin§418.
106)mustbemaderoutinelyavailableona24-hourbasis7daysaweek.
Othercoveredservicesmustbeavailableona24-hourbasiswhenreasonableandnecessarytomeettheneedsofthepatientandfamily.
L654(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(d)Standard:ContinuationofcareAhospicemaynotdiscontinueorreducecareprovidedtoaMedicareorMedicaidbeneficiarybecauseofthebeneficiary'sinabilitytopayforthatcare.
InterpretiveGuidelines§418.
100(d)ThisconditionappliestoMedicareandMedicaidbeneficiariesonly.
L655(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(e)Standard:ProfessionalmanagementresponsibilityAhospicethathasawrittenagreementwithanotheragency,individual,ororganizationtofurnishanyservicesunderarrangementmustretainadministrativeandfinancialmanagement,andoversightofstaffandservicesforallarrangedservices,toensuretheprovisionofqualitycare.
Arrangedservicesmustbesupportedbywrittenagreementsthatrequirethatallservicesbe--(1)Authorizedbythehospice;(2)Furnishedinasafeandeffectivemannerbyqualifiedpersonnel;and(3)Deliveredinaccordancewiththepatient'splanofcare.
InterpretiveGuidelines§418.
100(e)Thehospicemustretainadministrativeandfinancialmanagementresponsibility,andoversightofstaffandservicesprovidedunderarrangement.
ForMedicarepurposes,thehospiceisreimbursedforallcoveredservicesitprovides,whetherdirectlyorunderarrangement.
ItistheresponsibilityofthehospicetopayforthoseservicesprovidedtoMedicarebeneficiariesunderarrangement.
Whenahospiceprovidesservicesunderarrangementstonon-Medicarebeneficiaries,thehospiceisresponsibleforestablishinghowpaymentforthoseserviceswilloccur,butthestandarddoesnotrequirethehospicetopayforthoseservicesdirectlyortopayforservicesforwhichthereisnoreimbursementorforservicesthatanotherinsurerisobligatedtopay.
ProceduresandProbes§418.
100(e)Askhowthehospiceassuresthatallcontractedpersonnel(agency,individualororganization)providecarethatisinaccordancewiththepatientsplanofcareHowdoesthehospiceassurethatallservicesprovidedunderarrangementareauthorizedbythehospiceHowdoesthehospicemonitorandexercisecontroloverservicesprovidedbypersonnelunderarrangementsorcontractsHowdoesthehospiceassureprofessionalmanagementofpatientsthatarereceivinginpatientcareunderarrangementHowandwhendoescommunicationoccurbetweenthehospiceandcontractedindividuals,agenciesororganizationsHowdoesthehospiceassurethatservicesarefurnishedbyqualifiedstaffL656(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(f)Standard:HospicemultiplelocationsIfahospiceoperatesmultiplelocations,itmustmeetthefollowingrequirements:(1)Medicareapproval.
(i)AllhospicemultiplelocationsmustbeapprovedbyMedicarebeforeprovidinghospicecareandservicestoMedicarepatients.
InterpretiveGuidelines§418.
100(f)(1)(i)ItisinherentintheprovidercertificationprocessforahospicetonotifyCMSofitsproposaltoaddalocationfromwhichitprovidesservices.
Absentsuchnotification,CMShasnowayofcarryingoutthestatutorilymandatedobligationofdeterminingwhetherthehospiceiscomplyingwithallapplicableparticipationrequirementsatthenewlocation.
ItisalongstandingCMSpolicythatthereisnobasisforaprovidertobillMedicareforservicesprovidedfromalocationthathasnotbeendeterminedtomeetapplicablerequirementsofparticipation.
Thisguidanceiscontainedin§§2086and3224ofthismanual.
Whenanexistinghospiceintendstoaddamultiplelocation,itmustnotifyCMS,theStateSurveyAgency(SA),and,ifdeemed,itshouldnotifyitsapprovednationalaccreditationorganization(AO),inwritingoftheproposedlocationifitexpectsthislocationtoparticipateinMedicareorMedicaid.
ThehospicemustalsosubmitaFormCMS-855Achangeofinformationrequest(includingallsupportingdocumentation)toitsMedicareAdministrativeContractor(MAC)beforeCMSapprovalcanbegranted.
TheprovidermustobtainCMSapprovalofthenewlocationbeforeitispermittedtobillMedicareforservicesprovidedfromthenewlocation.
Uponreceiptofahospicesnoticeandrequestforapprovalofamultiplelocation,theCMSROwillcarefullyevaluatetheinformation,togetherwithanysupportingdocumentationfromthehospiceandanyotherrelevantinformationknowntotheROinmakingitsdecision.
Ifadecisioncanbemadebasedonthewrittenapplicationandsupportingdocumentation,CMSwillgrantordenyanapprovalwithoutrequiringasurvey.
If,however,theROconcludesthatcircumstanceswarrantasurveytoestablishwhetherthenewlocationcomplieswithallapplicablerequirements,CMSwilladvisetheproviderandwillmakenofurtherfindingsuntilaMedicarecertificationsurveyhasbeencompletedandsubmittedtoCMSforitsreview.
Ineitherevent,CMSwillnotifytheproviderofitsdecisioninwriting,asappropriate.
NOTE:CMSwillnotapproveahospicesinpatientfacilityorachangeoflocationforahospicesowninpatientfacilitywithoutasurveytoassurethatthefacilitymeetsallrequirementsspecifiedat42CFR418.
110.
AhospicemaynotbillMedicareforservicesprovidedfromamultiplelocationuntilthenewsiteorlocationhasbeenapprovedbyCMS.
ThefactthatanationalaccreditationorganizationwithdeemingauthorityhasapprovedanewsiteorlocationwillnotaffectCMSdecision.
CMSdeterminationwillbebasedonitsindependentapplicationofitsregulationstothefactsinthecase.
ServicesprovidedbeforetheeffectivedateofapprovalshouldnotbebilledtoMedicare.
Ifthehospicedoesoperateatmultiplelocations,adeficiencyfoundatanylocationwillresultinacomplianceissuefortheentirehospice.
L657(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(f)(1)(ii)Themultiplelocationmustbepartofthehospiceandmustshareadministration,supervision,andserviceswiththehospiceissuedthecertificationnumber.
Procedures§418.
100(f)(1)(ii)Askthehospicehowitassuresthatanymultiplelocationsoperatingasapartofthehospiceshareadministration,supervisionandservices,andparticipateinthehospicesQAPIactivities.
Howdoesthehospicecommunicatewiththemultiplelocation(s)toassurethatitisresponsibletothesamegoverningbodyandcentraladministrationthatgovernsthehospiceissuedtheprovideragreement,andthatthegoverningbodyandcentraladministrationareabletoadequatelymanagethelocation,resolveanyproblemsthatoccurandassurequalityofcareforallpatients.
L658(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(f)(1)(iii)Thelinesofauthorityandprofessionalandadministrativecontrolmustbeclearlydelineatedinthehospice'sorganizationalstructureandinpractice,andmustbetracedtothelocationwhichwasissuedthecertificationnumber.
L659(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(f)(1)(i)(iv)Thedeterminationthatamultiplelocationdoesordoesnotmeetthedefinitionofamultiplelocation,assetforthinthispart,isaninitialdetermination,assetforthin§498.
3.
InterpretiveGuidelines§418.
100(f)(1)(iv)Initialdeterminationsunder42CFR498.
3aresubjecttoadministrativereview.
L660(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(f)(2)Thehospicemustcontinuallymonitorandmanageallservicesprovidedatallofitslocationstoensurethatservicesaredeliveredinasafeandeffectivemannerandtoensurethateachpatientandfamilyreceivesthenecessarycareandservicesoutlinedintheplanofcare,inaccordancewiththerequirementsofthissubpartandsubpartsAandCofthissection.
InterpretiveGuidelines§418.
100(f)(2)Surveyorsmayconducttheentiresurveyorpartofthesurveyatthemultiplelocation(s).
Whenconductingasurveyatamultiplelocation,thesurveyormayrequestthatallnecessarydocumentationforreviewbetransportedtothatlocationatthehospicesexpense.
Thismayinclude,butnotbelimitedto,asampleofclinicalrecordsfromallotherlocations,QAPIreports,administrativerecords,personnelfiles,andpoliciesandprocedures.
Thereshouldbeevidencethat:Thehospiceexertsthesupervisionandcontrolnecessaryateachlocationtoassurethatallhospicecareandservicescontinuetoberesponsivetotheneedsofthepatient/familyatalltimesandinallsettings;Eachlocationprovidesthesamefullrangeofservicesthatisrequiredofthehospicethatwasissuedthecertificationnumber;EachpatientisassignedtoaspecificIDGresponsibleforongoingassessment,planning,monitoring,coordinationandprovisionofcare;Eachlocationisresponsibletothesamegoverningbodyandcentraladministrationthatgovernsthehospicethatwasissuedthecertificationnumber,andthegoverningbodyandcentraladministrationmustbeabletoadequatelymanagethelocationandassurequalityofcare.
L661(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(g)Standard:Training(1)Ahospicemustprovideorientationaboutthehospicephilosophytoallemployeesandcontractedstaffwhohavepatientandfamilycontact.
L662(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(g)(2)-Ahospicemustprovideaninitialorientationforeachemployeethataddressestheemployee'sspecificjobduties.
L663(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
100(g)(3)Ahospicemustassesstheskillsandcompetenceofallindividualsfurnishingcare,includingvolunteersfurnishingservices,and,asnecessary,providein-servicetrainingandeducationprogramswhererequired.
Thehospicemusthavewrittenpoliciesandproceduresdescribingitsmethod(s)ofassessmentofcompetencyandmaintainawrittendescriptionofthein-servicetrainingprovidedduringtheprevious12months.
ProceduresandProbes§418.
100(g)Reviewasampleofpersonnelrecordstoverifythatinitialorientation,assessmentofskillsandcompetency,andin-servicetrainingwasprovidedtoallemployees,contractedstaffandvolunteersfurnishingcare/servicestohospicepatientsandfamilies.
Reviewhospicewrittenagreementsandtrainingprogramsprovidedforcontractedpersonnel.
Ifconcernsareidentified,interviewtheadministratororhis/herdesignee,andstaffregardingthespecificissue.
L664(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
102ConditionofParticipation:Medicaldirector.
L665(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
102-Thehospicemustdesignateaphysiciantoserveasmedicaldirector.
Themedicaldirectormustbeadoctorofmedicineorosteopathywhoisanemployee,orisundercontractwith,thehospice.
Whenthemedicaldirectorisnotavailable,aphysiciandesignatedbythehospiceassumesthesameresponsibilitiesandobligationsasthemedicaldirector.
InterpretiveGuidelines§418.
102Thereisonlyonemedicaldirectorforthehospice,includingallmultiplelocations,ifithasthem.
Thatindividualmayworkfulltimeorparttime.
Ifthemedicaldirectorisnotapaidemployeeoracontractedmedicaldirector,he/sheisconsideredavolunteerunderthecontrolofthehospice.
Allotherhospicephysiciansfunctionunderthesupervisionofthemedicaldirector.
ProceduresandProbes§418.
102Identifythroughinterviewanddocumentationwhothemedicaldirectorisandwhoisdesignatedtoserveinthiscapacityinhis/herabsence.
L666(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
102(a)Standard:Medicaldirectorcontract.
(1)Ahospicemaycontractwitheitherofthefollowing—(i)Aself-employedphysician;or(ii)Aphysicianemployedbyaprofessionalentityorphysiciansgroup.
Whencontractingformedicaldirectorservices,thecontractmustspecifythephysicianwhoassumesthemedicaldirectorresponsibilitiesandobligations.
InterpretiveGuidelines§418.
102(a)Themedicaldirectormayalsobeavolunteerphysicianunderthecontrolofthehospice,aslongasthispersonmeetsallFederalandStaterequirementsforahospicephysician.
L667(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
102(b)Standard:Initialcertificationofterminalillness.
Themedicaldirectororphysiciandesigneereviewstheclinicalinformationforeachhospicepatientandprovideswrittencertificationthatitisanticipatedthatthepatient'slifeexpectancyis6monthsorlessiftheillnessrunsitsnormalcourse.
Thephysicianmustconsiderthefollowingwhenmakingthisdetermination:(1)Theprimaryterminalcondition;(2)Relateddiagnosis(es),ifany;(3)Currentsubjectiveandobjectivemedicalfindings;(4)Currentmedicationandtreatmentorders;and(5)Informationaboutthemedicalmanagementofanyofthepatient'sconditionsunrelatedtotheterminalillness.
InterpretiveGuidelines§418.
102(b)Themedicaldirectororphysiciandesignee(whoisahospiceemployeeorundercontractwiththehospice)hastheresponsibilityforthemedicalcomponentofthehospicespatientcareprogram,includinginitialcertificationsandrecertificationsofterminalillness.
Duringtheclinicalrecordreview,verifythattheclinicalinformationnecessaryforcertificationispresentintherecord.
L668(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
102(c)Standard:Recertificationoftheterminalillness.
Beforetherecertificationperiodforeachpatient,asdescribedin§418.
21(a),themedicaldirectororphysiciandesigneemustreviewthepatient'sclinicalinformation.
L669(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
102(d)Standard:Medicaldirectorresponsibility.
Themedicaldirectororphysiciandesigneehasresponsibilityforthemedicalcomponentofthehospice'spatientcareprogram.
InterpretiveGuidelines§418.
102(d)Thesingleindividualwhofillstheroleofthemedicaldirectorassumesoverallresponsibilityforthemedicalcomponentofthehospicespatientcareprogram.
Thisresponsibility,whichextendstoallhospicemultiplelocations,includesoverseeingtheimplementationoftheentirephysician,nursing,socialwork,therapy,andcounselingareaswithinthehospicetoensurethattheseareasconsistentlymeetpatientandfamilyneeds.
L670(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104Conditionofparticipation:Clinicalrecords.
L671(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104-Aclinicalrecordcontainingpastandcurrentfindingsismaintainedforeachhospicepatient.
Theclinicalrecordmustcontaincorrectclinicalinformationthatisavailabletothepatient'sattendingphysicianandhospicestaff.
Theclinicalrecordmaybemaintainedelectronically.
L672(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(a)Standard:Content.
Eachpatient'srecordmustincludethefollowing:(1)Theinitialplanofcare,updatedplansofcare,initialassessment,comprehensiveassessment,updatedcomprehensiveassessments,andclinicalnotes.
L673(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(a)(2)Signedcopiesofthenoticeofpatientrightsinaccordancewith§418.
52andelectionstatementinaccordancewith§418.
24.
L674(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(a)(3)-Responsestomedications,symptommanagement,treatments,andservices.
L675(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(a)(4)-Outcomemeasuredataelements,asdescribedin§418.
54(e)ofthissubpart.
L676(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(a)(5)-Physiciancertificationandrecertificationofterminalillnessasrequiredin§418.
22and§418.
25anddescribedin§418.
102(b)and§418.
102(c)respectively,ifappropriate.
L677(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(a)(6)-Anyadvancedirectivesasdescribedin§418.
52(a)(2).
L678(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(a)(7)-Physicianorders.
L679(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(b)Standard:Authentication.
Allentriesmustbelegible,clear,complete,andappropriatelyauthenticatedanddatedinaccordancewithhospicepolicyandcurrentlyacceptedstandardsofpractice.
InterpretiveGuidelines§418.
104(b)Ahospicemaycreateitsownpolicyonauthenticationofclinicalrecordsbasedonacceptedstandardsofpractice.
HospicesmustfollowStatelawsregardingauthenticationofclinicalrecords,and,withinthiscontext,altertheirpoliciesasoftenasnecessarytoadapttochangingtechnologiesandpractices.
Medicarerequiresalegibleidentifierforservicesprovided/ordered.
Thismethodmustbehandwritten(notstamped)oranelectronicsignaturetosignanorderorotherclinicalrecorddocumentation.
Thenotedexceptionisthatfacsimilesoforiginalwrittenorelectronicsignaturesareacceptableforthecertificationsofterminalillnessforhospice.
Stampedsignaturesarenotacceptable.
Providersandphysiciansusingelectronicsignaturesshouldrecognizethatthereisapotentialformisuseorabusewithalternatesignaturemethods.
Forexample,providersneedasystemandsoftwareproductsthatareprotectedagainstmodification,etc.
,andshouldapplyadministrativeproceduresthatareadequateandcorrespondtorecognizedstandardsandlaws.
Theindividualwhosenameisonthealternatesignaturemethodaswellastheproviderbeartheresponsibilityfortheauthenticityoftheinformationtowhichtheyhaveattested.
Physiciansshouldcheckwiththeirattorneysandmalpracticeinsurersinregardtotheuseofalternativesignaturemethods.
Hospicesmaynotacceptstampedphysiciansignaturesonorders,treatments,orotherdocumentsthatareapartofthepatient'sclinicalrecord.
Surveyorsmusthaveaccesstoclinicalrecords.
Iftherecordismaintainedelectronically,thehospicemustprovideallequipmentnecessarytoreadtherecordinitsentirety.
Thehospicemustalsoproduceapapercopyoftherecord,ifrequestedbythesurveyor.
AllStatelicensureandStatepracticeregulationscontinuetoapplytoMedicare-approvedhospices.
WhereStatelawismorerestrictivethanMedicare,thehospiceneedstoapplytheStatelawstandard.
ProceduresandProbes§418.
104(b)Askthehospicetoexplaintheirsystemofauthentication.
Verifythatataminimumitincludesthefollowingsafeguards:Thehospicehasamethodtoidentifytheauthorofeachentry.
Thiswouldincludeverificationoftheauthoroffaxedorders/entriesorcomputerentries.
Ifthehospiceisusingelectronicmedicalrecords,electronicauthenticationmusthaveauserIDandpasswordprotectionsinplace.
Everyentry,bothwrittenandelectronic,mustbesignedanddatedbythepersonperformingtheservice.
L680(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(c)Standard:ProtectionofinformationTheclinicalrecord,itscontentsandtheinformationcontainedthereinmustbesafeguardedagainstlossorunauthorizeduse.
ThehospicemustbeincompliancewiththeDepartment'srulesregardingpersonalhealthinformationassetoutat45CFRparts160and164.
InterpretiveGuidelines§418.
104(c)Thehospicemustensurethatunauthorizedindividualscannotgainaccesstopatientrecords,andthatindividualscannotalterpatientrecords.
ProceduresandProbes§418.
104(c)Howdoesthehospiceprotecttheconfidentialityofclinicalrecords.
WhatisthehospicespolicyonleavingandprotectingclinicalrecordinformationinthepatientshomeIfthehospiceuseselectronicpatientrecords,whatsecuritysafeguardsareinplacetoprotecttheelectronicsystemagainstloss,theft,damage,disruptionofoperationsorunauthorizeduseIsaccesstoclinicalrecordscontrolledAretheremeasuresinplacetoprotectthepatientfromidentitytheftObservethehospicessecuritypracticesforpatientrecords.
Arepatientrecords(hardcopyorelectronic)leftunsecuredorunattendedVerifythatadequateprecautionsaretakentopreventphysicalorelectronicaltering.
L681(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(d)Standard:RetentionofrecordsPatientclinicalrecordsmustberetainedfor6yearsafterthedeathordischargeofthepatient,unlessStatelawstipulatesalongerperiodoftime.
Ifthehospicediscontinuesoperation,hospicepoliciesmustprovideforretentionandstorageofclinicalrecords.
ThehospicemustinformitsStateagencyanditsCMSRegionalofficewheresuchclinicalrecordswillbestoredandhowtheymaybeaccessed.
L682(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(e)Standard:Dischargeortransferofcare(1)IfthecareofapatientistransferredtoanotherMedicare/Medicaid-certifiedfacility,thehospicemustforward,tothereceivingfacility,acopyof-(i)Thehospicedischargesummary;and(ii)Thepatient'sclinicalrecord,ifrequested.
L683(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(e)(2)-Ifapatientrevokestheelectionofhospicecare,orisdischargedfromhospiceinaccordancewith§418.
26,thehospicemustforwardtothepatient'sattendingphysician,acopyof-(i)Thehospicedischargesummary;and(ii)Thepatient'sclinicalrecord,ifrequested.
L684(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(e)(3)-Thehospicedischargesummaryasrequiredby(e)(1)and(e)(2)ofthissectionmustinclude—(i)Asummaryofthepatient'sstayincludingtreatments,symptomsandpainmanagement;(ii)Thepatient'scurrentplanofcare;(iii)Thepatient'slatestphysicianorders;and(iv)Anyotherdocumentationthatwillassistinpost-dischargecontinuityofcareorthatisrequestedbytheattendingphysicianorreceivingfacility.
InterpretiveGuidelines§418.
104(e)ForfurtherinformationregardingrevocationorterminationofhospiceservicesseeChapter2,§2081and§2082ofthismanual.
L685(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
104(f)Standard:RetrievalofclinicalrecordsTheclinicalrecord,whetherhardcopyorinelectronicform,mustbemadereadilyavailableonrequestbyanappropriateauthority.
InterpretiveGuidelines§418.
104(f)AnappropriateauthorityincludesrepresentativesfromtheSAorotherauthorizedentity,whovisitsthehospiceforthepurposeofdetermininginaccordancewithSection1864(a)oftheActwhetherthehospiceismeetingallconditionsofparticipation.
Iftheclinicalrecordismaintainedelectronically,thehospicemustprovideallequipmentnecessarytoreadtherecordinitsentirety.
Thehospicemustalsoproduceapapercopyoftherecord,ifrequestedbythesurveyor.
Inaddition,ascertainhowthehospiceensuresthattherecordisup-to-dateincludingdocumentationofrecentservices/visitsorhandwrittennotesheldbystaffthatwerenotincludedintherecordwhenthepapercopywasproduced.
L686(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106Conditionofparticipation:Drugsandbiologicals,medicalsupplies,anddurablemedicalequipment.
L687(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106-Medicalsuppliesandappliances,asdescribedin§410.
36ofthischapter;durablemedicalequipment,asdescribedin§410.
38ofthischapter;anddrugsandbiologicalsrelatedtothepalliationandmanagementoftheterminalillnessandrelatedconditions,asidentifiedinthehospiceplanofcare,mustbeprovidedbythehospicewhilethepatientisunderhospicecare.
L688(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(a)Standard:Managingdrugsandbiologicals.
(1)ThehospicemustensurethattheinterdisciplinarygroupconferswithanindividualwitheducationandtrainingindrugmanagementasdefinedinhospicepoliciesandproceduresandStatelaw,whoisanemployeeoforundercontractwiththehospicetoensurethatdrugsandbiologicalsmeeteachpatient'sneeds.
InterpretiveGuidelines§418.
106(a)Hospicesmustconferwithanindividualwitheducationandtrainingindrugmanagement,anduseacceptablestandardsofpracticeforhospicepatientstoselectthemostappropriatedrugstomeetaparticularpatientsneed.
Conferencesmaytakeplaceinpersonorthroughothermeansofcommunication(e.
g.
,teleconference,FAX,electronicallyetc.
).
Thehospiceshouldalsobeabletoexplaindrugchoicestothoseprovidingpatientcare,thepatientorrepresentative,thefamily,andanyauthorityhavingjurisdiction,asnecessary.
Individualswitheducationandtrainingindrugmanagementmayinclude:licensedpharmacists;physicianswhoareboardcertifiedinpalliativemedicine;RNswhoarecertifiedinpalliativecare;andphysicians,RNsandnursepractitionerswhocompleteaspecifichospiceorpalliativecaredrugmanagementcourse,andotherindividualsasallowedbyStatelaw.
Thehospicemustbeabletodemonstratethattheindividualhasspecificeducationandtrainingindrugmanagement.
L689(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)(2)Ahospicethatprovidesinpatientcaredirectlyinitsownfacilitymustprovidepharmacyservicesunderthedirectionofaqualifiedlicensedpharmacistwhoisanemployeeoforundercontractwiththehospice.
Theprovidedpharmacistservicesmustincludeevaluationofapatient'sresponsetomedicationtherapy,identificationofpotentialadversedrugreactions,andrecommendedappropriatecorrectiveaction.
L690(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(b)Standard:Orderingofdrugs.
(1)OnlyaphysicianasdefinedbySection1861(r)(1)oftheAct,oranursepractitionerinaccordancewiththeplanofcareandStatelaw,mayorderdrugsforthepatient.
(2)Ifthedrugorderisverbalorgivenbyorthroughelectronictransmission—(i)Itmustbegivenonlytoalicensednurse,nursepractitioner(whereappropriate),pharmacist,orphysician;and(ii)TheindividualreceivingtheordermustrecordandsignitimmediatelyandhavetheprescribingpersonsignitinaccordancewithStateandFederalregulations.
L691(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(c)Standard:Dispensingofdrugsandbiologicals.
Thehospicemust—(1)Obtaindrugsandbiologicalsfromcommunityorinstitutionalpharmacistsorstockdrugsandbiologicalsitself.
(2)Thehospicethatprovidesinpatientcaredirectlyinitsownfacilitymust:(i)Haveawrittenpolicyinplacethatpromotesdispensingaccuracy;and(ii)Maintaincurrentandaccuraterecordsofthereceiptanddispositionofallcontrolleddrugs.
InterpretiveGuidelines§418.
106(c)Abiologicalisanymedicinalpreparationmadefromlivingorganismsandtheirproductsincluding,butnotlimitedto,serums,vaccines,antigens,andantitoxins.
L692(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(d)Standard:Administrationofdrugsandbiologicals.
(1)Theinterdisciplinarygroup,aspartofthereviewoftheplanofcare,mustdeterminetheabilityofthepatientand/orfamilytosafelyself-administerdrugsandbiologicalstothepatientinhisorherhome.
(2)Patientsreceivingcareinahospicethatprovidesinpatientcaredirectlyinitsownfacilitymayonlybeadministeredmedicationsbythefollowingindividuals:(i)Alicensednurse,physician,orotherhealthcareprofessionalinaccordancewiththeirscopeofpracticeandStatelaw;(iii)AnemployeewhohascompletedaState-approvedtrainingprograminmedicationadministration;and(iv)Thepatient,uponapprovalbytheinterdisciplinarygroup.
InterpretiveGuidelines§418.
106(d)Thepatientsindividualizedwrittenplanofcareshouldidentifyifthepatientand/orfamilyareself-administeringdrugsandbiologicals.
Ifthepatientand/orfamilyarenotcapableofsafelyadministeringdrugsandbiologicalsinthehome,thehospicemustaddressthisissueinthepatientsplanofcare.
L693(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)Standard:Labeling,disposing,andstoringofdrugsandbiologicals(1)Labeling.
Drugsandbiologicalsmustbelabeledinaccordancewithcurrentlyacceptedprofessionalpracticeandmustincludeappropriateusageandcautionaryinstructions,aswellasanexpirationdate(ifapplicable).
InterpretiveGuidelines§418.
106(e)(1)Thehospicemusthaveasystemtoensurethattheydonotprovidetotheirpatients(eitherdirectlyorunderarrangement)outdated,mislabeled,orotherwiseunusabledrugsandbiologicals.
L694(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)(2)Disposing.
(i)Safeuseanddisposalofcontrolleddrugsinthepatient'shome.
Thehospicemusthavewrittenpoliciesandproceduresforthemanagementanddisposalofcontrolleddrugsinthepatient'shome.
Atthetimewhencontrolleddrugsarefirstorderedthehospicemust:L695(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)(2)(A)-Provideacopyofthehospicewrittenpoliciesandproceduresonthemanagementanddisposalofcontrolleddrugstothepatientorpatientrepresentativeandfamily;L696(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)(2)(B)-Discussthehospicepoliciesandproceduresformanagingthesafeuseanddisposalofcontrolleddrugswiththepatientorrepresentativeandthefamilyinalanguageandmannerthattheyunderstandtoensurethatthesepartiesareeducatedregardingthesafeuseanddisposalofcontrolleddrugs;andInterpretiveGuidelines§418.
106(e)(2)(B)Thehospicespoliciesandproceduresmayalsoaddressthesafeuseanddisposalofcontrolleddrugsatothertimes,suchaswhenadrugisdiscontinued,anewcontrolleddrugisordered,orwhenthepatientdies.
L697(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)(2)(C)-Documentinthepatient'sclinicalrecordthatthewrittenpoliciesandproceduresformanagingcontrolleddrugswasprovidedanddiscussed.
L698(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)(2)(C)(ii)-Disposalofcontrolleddrugsinhospicesthatprovideinpatientcaredirectly.
ThehospicethatprovidesinpatientcaredirectlyinitsownfacilitymustdisposeofcontrolleddrugsincompliancewiththehospicepolicyandinaccordancewithStateandFederalrequirements.
Thehospicemustmaintaincurrentandaccuraterecordsofthereceiptanddispositionofallcontrolleddrugs.
L699(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)(3)Storing-Thehospicethatprovidesinpatientcaredirectlyinitsownfacilitymustcomplywiththefollowingadditionalrequirements-(i)Alldrugsandbiologicalsmustbestoredinsecureareas.
AllcontrolleddrugslistedinSchedulesII,III,IV,andVoftheComprehensiveDrugAbusePreventionandControlActof1976mustbestoredinlockedcompartmentswithinsuchsecurestorageareas.
Onlypersonnelauthorizedtoadministercontrolleddrugsasnotedinparagraph(d)(2)ofthissectionmayhaveaccesstothelockedcompartments;andInterpretiveGuidelines§418.
106(e)(3)(1)Compartmentsinthecontextoftheseregulationsinclude,butarenotlimitedto,drawers,cabinets,rooms,refrigerators,andcarts.
Theprovisionsfor"authorizedpersonnel"tohaveaccesstokeysmustbedeterminedbythehospicemanagementinaccordancewithFederal,State,andlocallawsandfacilitypractice.
L700(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(e)(3)(ii)-Discrepanciesintheacquisition,storage,dispensing,administration,disposal,orreturnofcontrolleddrugsmustbeinvestigatedimmediatelybythepharmacistandhospiceadministratorandwhererequiredreportedtotheappropriateStateauthority.
AwrittenaccountoftheinvestigationmustbemadeavailabletoStateandFederalofficialsifrequiredbylaworregulation.
L701(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(f)Standard:Useandmaintenanceofequipmentandsupplies(1)Thehospicemustensurethatmanufacturerrecommendationsforperformingroutineandpreventivemaintenanceondurablemedicalequipmentarefollowed.
Theequipmentmustbesafeandworkasintendedforuseinthepatient'senvironment.
Whereamanufacturerrecommendationforapieceofequipmentdoesnotexist,thehospicemustensurethatrepairandroutinemaintenancepoliciesaredeveloped.
Thehospicemayusepersonsundercontracttoensurethemaintenanceandrepairofdurablemedicalequipment.
L702(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(f)(2)-Thehospicemustensurethatthepatient,whereappropriate,aswellasthefamilyand/orothercaregiver(s),receiveinstructioninthesafeuseofdurablemedicalequipmentandsupplies.
Thehospicemayusepersonsundercontracttoensurepatientandfamilyinstruction.
Thepatient,family,and/orcaregivermustbeabletodemonstratetheappropriateuseofdurablemedicalequipmenttothesatisfactionofthehospicestaff.
InterpretiveGuidelines§418.
106(f)(2)Theinstructiongiventothepatient/familyontheuseoftheDMEandsuppliesmustbedocumentedinthepatientsclinicalrecord,aswellasthepatient/familysunderstandingofthesafeuseoftheDMEandsupplies.
ProceduresandProbes§418.
106(f)(2)Duringhomevisitsaskthepatient,whereappropriate,familyand/orothercaregiver(s),todescribeanyinstructionsreceivedregardingtheuseofdurablemedicalequipmentandsupplies.
Hasthepatient/familyhadanyproblemswiththeequipmentreceivedDoestheDMEfunctionasrequiredandintendedClinicalrecorddocumentationshouldverify/supporttheirresponses.
L703(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
106(f)(3)-HospicesmayonlycontractfordurablemedicalequipmentserviceswithadurablemedicalequipmentsupplierthatmeetstheMedicareDMEPOSSupplierQualityandAccreditationStandardsat42CFR§424.
57.
InterpretiveGuidelines§418.
106(f)(3)DMEPOSistheacronymforDurableMedicalEquipmentProsthetics,OrthoticsandSupplies.
AllDMEPOSsuppliersarerequiredunderseparaterulemakingtobeaccreditedbySeptember30,2009,inordertoreceiveMedicarepayment.
IfahospicehasacontractwithaDMEsupplier(thathasaMedicaresupplierbillingnumber),thehospiceshouldhavealetterinitsfilefromtheDMEsupplierstatingthattheDMEsupplierisaccredited.
IfthehospicecontractswithaDMEsupplierthatonlyserveshospices,(thereforenoMedicaresuppliernumber),thehospicewillstillneedtohavealetterinitsfilefromtheDMEsupplierstatingthattheDMEisaccredited.
IfthehospiceownsitsownDME,noaccreditationisneeded.
L704(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108Conditionofparticipation:Short-terminpatientcare.
L705(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108-Inpatientcaremustbeavailableforpaincontrol,symptommanagement,andrespitepurposes,andmustbeprovidedinaparticipatingMedicareorMedicaidfacility.
L706(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(a)Standard:Inpatientcareforsymptommanagementandpaincontrol.
Inpatientcareforpaincontrolandsymptommanagementmustbeprovidedinoneofthefollowing:(1)AMedicare-certifiedhospicethatmeetstheconditionsofparticipationforprovidinginpatientcaredirectlyasspecifiedin§418.
110.
L707(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(a)(2)-Medicare-certifiedhospitaloraskillednursingfacilitythatalsomeetsthestandardsspecifiedin§418.
110(b)and(e)regarding24-hournursingservicesandpatientareas.
L708(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(b)Standard:Inpatientcareforrespitepurposes(1)Inpatientcareforrespitepurposesmustbeprovidedbyoneofthefollowing:(i)Aproviderspecifiedinparagraph(a)ofthissection.
L709(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(b)(1)(ii)-AMedicareorMedicaid-certifiednursingfacilitythatalsomeetsthestandardsspecifiedin§418.
110(e).
L710(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(b)(2)-Thefacilityprovidingrespitecaremustprovide24-hournursingservicesthatmeetthenursingneedsofallpatientsandarefurnishedinaccordancewitheachpatient'splanofcare.
Eachpatientmustreceiveallnursingservicesasprescribedandmustbekeptcomfortable,clean,well-groomed,andprotectedfromaccident,injury,andinfection.
InterpretiveGuidelines§418.
108(b)(2)Thehospicemustassurethattheinpatientfacilityhasenoughnursingpersonnelpresentonallshiftstoguaranteethatadequatesafetymeasuresareinplaceforthepatients,andthattheroutine,special,andemergencyneedsofallpatientsaremetatalltimes.
L711(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(c)Standard:InpatientcareprovidedunderarrangementsIfthehospicehasanarrangementwithafacilitytoprovideforshort-terminpatientcare,thearrangementisdescribedinawrittenagreement,coordinatedbythehospiceandataminimumspecifies—(1)Thatthehospicesuppliestheinpatientprovideracopyofthepatient'splanofcareandspecifiestheinpatientservicestobefurnished;L712(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(c)(2)-Thattheinpatientproviderhasestablishedpatientcarepoliciesconsistentwiththoseofthehospiceandagreestoabidebythepalliativecareprotocolsandplanofcareestablishedbythehospiceforitspatients;L713(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(c)(3)-Thatthehospicepatient'sinpatientclinicalrecordincludesarecordofallinpatientservicesfurnishedandeventsregardingcarethatoccurredatthefacility;thatacopyofthedischargesummarybeprovidedtothehospiceatthetimeofdischarge;andthatacopyoftheinpatientclinicalrecordisavailabletothehospiceatthetimeofdischarge;L714(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(c)(4)-Thattheinpatientfacilityhasidentifiedanindividualwithinthefacilitywhoisresponsiblefortheimplementationoftheprovisionsoftheagreement;L715(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(c)(5)-Thatthehospiceretainsresponsibilityforensuringthatthetrainingofpersonnelwhowillbeprovidingthepatient'scareintheinpatientfacilityhasbeenprovidedandthatadescriptionofthetrainingandthenamesofthosegivingthetrainingaredocumented;andL716(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(c)(6)-Amethodforverifyingthattherequirementsinparagraphs(c)(1)through(c)(5)ofthissectionaremet.
InterpretiveGuidelines§418.
108(c)(6)Hospicesmayhavearrangementswithmorethanonefacilityfortheprovisionofinpatientcare.
ProceduresandProbes§418.
108(c)(6)Askthehospiceclinicalmanagerwhatfacilitiestheyuseandhowtheymonitorthecaretheirpatientsreceiveateachfacility.
Ifyouhavequestionsconcerningtheprovisionofcareorthehospicesexplanationofhowtheymonitorcareatthefacility(ies),asktoreviewacopyoftheirwrittenagreement.
Askhowthehospiceassuresthatallstaffcaringforhospicepatientsattheinpatientfacility(ies)havebeentrainedinthehospicephilosophyofcareandareabletoprovidepatientcareaccordingtothehospiceplanofcare.
Ifnecessary,contactorvisitthefacility(ies)asneededtoverifycompliance.
L717(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(d)Standard:InpatientcarelimitationThetotalnumberofinpatientdaysusedbyMedicarebeneficiarieswhoelectedhospicecoverageina12-monthperiodinaparticularhospicemaynotexceed20percentofthetotalnumberofhospicedaysconsumedintotalbythisgroupofbeneficiaries.
InterpretiveGuidelines§418.
108(d)ThisstandardappliestoMedicarebeneficiariesonly.
CompliancewiththisregulationisbasedonthetotalnumberofMedicarebeneficiariesenrolledinthehospiceprogram,anddoesnotincludepatientsfromotherpayorsources.
L718(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
108(e)Standard:ExemptionfromlimitationBeforeOctober1,1986,anyhospicethatbeganoperationbeforeJanuary1,1975,isnotsubjecttothelimitationspecifiedinparagraph(d)ofthissection.
L719(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110Conditionofparticipation:HospicesthatprovideinpatientcaredirectlyL720(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110-Ahospicethatprovidesinpatientcaredirectlyinitsownfacilitymustdemonstratecompliancewithallofthefollowingstandards:L721(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(a)Standard:StaffingThehospiceisresponsibleforensuringthatstaffingforallservicesreflectsitsvolumeofpatients,theiracuity,andthelevelofintensityofservicesneededtoensurethatplanofcareoutcomesareachievedandnegativeoutcomesareavoided.
InterpretiveGuidelines418.
110(a)Theintentofthisregulationistoensurethatthehospiceprovidesstaffingthatisadequatetomeetpatientneeds.
Adequatestaffmeansthatthenumbersandtypesofqualified,trained,andexperiencedstaffontheinpatientunitmeetthecareneedsofeverypatient.
ProceduresandProbes418.
110(a)Howdoesthehospiceassurethatthereisadequatestaffonduty,especiallyduringtheevening,nighttime,weekendsandholidayshifts,totakecareoftheindividualneedsofallpatientsInterviewpatients/familytodetermineiftheyweresatisfiedwiththecareandservicestheyreceived.
Ifanon-sitevisitisconducted,observeifthestaffisresponsivetopatientneedsandifcallbellsareansweredpromptly.
DopatientsfrequentlycallforassistanceArepatientscheckedfrequentlyforsafety,comfortandpositioningAskhospicemanagementfortheinpatientstaffingschedulesandpatientcensusforthepastmonthtodetermineifstaffingwasadequatetomeetpatientneeds.
Howdoesthehospicedeterminethestaff-to-patientratiosoneachshiftReviewatleastoneclinicalrecordtoevaluateifstaffprovidedthetreatments,medications,personalcare,anddietincompliancewiththepatientsplanofcare.
Ifquestionsariseregardingstaffingpatterns(staffillness,staffnotreportingtowork,etc.
,)reviewthefacilitysstaffingscheduleand/ortimecardsasnecessary.
L722(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(b)Standard:Twenty-fourhournursingservices(1)Thehospicefacilitymustprovide24-hournursingservicesthatmeetthenursingneedsofallpatientsandarefurnishedinaccordancewitheachpatient'splanofcare.
Eachpatientmustreceiveallnursingservicesasprescribedandmustbekeptcomfortable,clean,well-groomed,andprotectedfromaccident,injury,andinfection.
L723(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(b)(2)-Ifatleastonepatientinthehospicefacilityisreceivinggeneralinpatientcare,theneachshiftmustincludearegisterednursewhoprovidesdirectpatientcare.
InterpretiveGuidelines§418.
110(b)(2)Thegeneralinpatientcareprovidedinafacilityforpaincontroloracuteorchronicsymptommanagement,whichcannotbemanagedinothersettings,isadifferentlevelofcarethanrespitecare.
ItisnotautomaticallynecessarytohaveanRNassignedtoeveryshifttoprovidedirectpatientcareiftheonlyhospicepatientsinafacilityarereceivingtherespiteorroutinelevelsofcare.
Staffingforafacilitysolelyprovidingtherespiteorroutinehomecarelevelsofcaretohospicepatientsshouldbebasedoneachpatientscareneeds.
Therequirementsfornursingservicesforrespitecarearelocatedat§418.
108(b)(2).
ProceduresandProbes§418.
110(b)(2)AskthehospiceforascheduleofRNpersonnelforthepastmonthandinquireaboutthemechanismtoensureanRNprovidesdirectpatientcareoneachshift.
L724(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(c)Standard:Physicalenvironment.
Thehospicemustmaintainasafephysicalenvironmentfreeofhazardsforpatients,staff,andvisitors.
L725(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(c)(1)-Safetymanagement.
(i)-Thehospicemustaddressrealorpotentialthreatstothehealthandsafetyofthepatients,others,andproperty.
ProceduresandProbes§418.
110(c)(1)(i)Askthehospicewhatsecuritymechanismsareinplaceandbeingfollowedtoprotectpatients,staffandvisitors.
Reviewandanalyzedocumentationrelatedtopatientandstaffincidentsandaccidentstoidentifyanyincidents/accidentsorpatternsofincidents/accidentsconcerningasafeenvironment.
Expandyourreviewifyoususpectaproblemwithasafeenvironmentinthehospice.
Ifthehospicehasidentifiedproblems,diditevaluatethoseproblemsandtakestepstoensureasafepatientenvironmentHowdoesthehospiceassurethatstafffollowscurrentstandardsofpracticeforpatientenvironmentalsafety,infectioncontrol,andsecurityL726(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(c)(1)(ii)-Thehospicemusthaveawrittendisasterpreparednessplanineffectformanagingtheconsequencesofpowerfailures,naturaldisasters,andotheremergenciesthatwouldaffectthehospice'sabilitytoprovidecare.
Theplanmustbeperiodicallyreviewedandrehearsedwithstaff(includingnon-employeestaff)withspecialemphasisplacedoncarryingouttheproceduresnecessarytoprotectpatientsandothers.
InterpretiveGuidelines§418.
110(c)(1)(ii)ThereshouldbedocumentationofLSCfiredrillsatvariedtimesonallshifts.
Forexample,firedrillsonthedayshiftshouldnotalwaysoccurat10:00A.
M.
Furtherinformationondisasterpreparednessguidanceisavailableathttp://www.
nfpa.
org/assets/files/PDF/NFPA1600.
pdfProceduresandProbes§418.
110(c)(1)(ii)Requestacopyofthehospicedisasterpreparednessplananddetermineifthecontentaddressesthemanagementofpowerfailures,naturaldisasters,andotherpotentialemergencies,specifictothehospiceslocation.
Requestacopyofstaff(bothemployedandvolunteerstaff)orientation/periodiceducationofthecomponentsofthedisasterplan.
Whatisthehospicesprocedurefornotificationofstaff,patients,physicians,andothersinanemergencyWheredoesthehospicedocumentandmaintainitsdated,writtenreport,andevaluationofeachdrillRequestandreviewthisinformation.
Interviewrandomstafftoassesstheirknowledgeofspecificresponsibilitiesduringadisasterordrillandwhattodoinaspecificemergencyi.
e.
fireinapatientsroom.
Areevacuationdiagramspostedandvisibletoallstaff,patient,andfamilymembersReviewevidenceofspecificplanningforinternalandexternaldisasters,patient/recordtransfers,andarrangementswithcommunityresources.
L727(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(c)(2)-Physicalplantandequipment.
Thehospicemustdevelopproceduresforcontrollingthereliabilityandqualityof--(i)Theroutinestorageandpromptdisposaloftrashandmedicalwaste;(ii)Light,temperature,andventilation/airexchangesthroughoutthehospice;(iii)Emergencygasandwatersupply;and(iv)Thescheduledandemergencymaintenanceandrepairofallequipment.
InterpretativeGuidelines§418.
110(c)(2)Thetermtrashreferstocommongarbageaswellasbiohazardouswaste.
ThestorageanddisposaloftrashandmedicalwasteshouldbeinaccordancewithFederal,Stateandlocallawsandregulations(i.
e.
,theEnvironmentalProtectionAgency,OccupationalHealthandSafetyAdministration(OSHA),CDC,Stateenvironmental,healthandsafetyregulations).
Thehospicemusthaveasystemtoprovideemergencygasandwaterasneededtoprovidecaretoinpatients.
Thisincludesmakingarrangementswithlocalutilitycompaniesandothersfortheprovisionofemergencysourcesofwaterandgas.
Thehospiceshouldconsidernationallyacceptedreferencesorcalculationsmadebyqualifiedstaffwhendeterminingtheneedforatleastwaterandgas.
Forexample,onesourceforinformationonwateristheFederalEmergencyManagementAgency(FEMA).
ProceduresandProbes§418.
110(c)(2)Askthehospicetoexplainitssystemforprovidingemergencygasandwaterandroutineandpreventivemaintenanceschedulesforequipment.
Determinethatongoingmaintenanceinspectionsareperformed,andthatnecessaryrepairsarecompleted.
Howdoesthehospiceassurethereliabilityandqualityoflight,temperature,andventilation/airexchangesthroughoutthehospiceL728(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(d)Standard:Fireprotection(1)Exceptasotherwiseprovidedinthissection--(i)Thehospicemustmeettheprovisionsapplicabletonursinghomesofthe2000editionoftheLifeSafetyCode(LSC)oftheNationalFireProtectionAssociation(NFPA).
TheDirectoroftheOfficeoftheFederalRegisterhasapprovedtheNFPA1012000editionoftheLifeSafetyCode,issuedJanuary14,2000,forincorporationbyreferenceinaccordancewith5U.
S.
C.
552(a)and1CFRpart51.
AcopyofthecodeisavailableforinspectionattheCMSInformationResourceCenter,7500SecurityBoulevard,Baltimore,MDorattheNationalArchivesandRecordsAdministration(NARA).
ForinformationontheavailabilityofthismaterialatNARA,call202-741-6030,orgoto:http://www.
archives.
gov/federalregister/codeoffederalregulations/ibrlocations.
html.
CopiesmaybeobtainedfromtheNationalFireProtectionAssociation,1BatterymarchPark,Quincy,MA02269.
IfanychangesintheeditionoftheCodeareincorporatedbyreference,CMSwillpublishanoticeintheFederalRegistertoannouncethechanges.
(ii)Chapter19.
3.
6.
3.
2,exceptionnumber2oftheadoptededitionoftheLSCdoesnotapplytohospices.
(2)InconsiderationofarecommendationbytheStatesurveyagency,CMSmaywaive,forperiodsdeemedappropriate,specificprovisionsoftheLifeSafetyCodewhich,ifrigidlyappliedwouldresultinunreasonablehardshipforthehospice,butonlyifthewaiverwouldnotadverselyaffectthehealthandsafetyofpatients.
(3)TheprovisionsoftheadoptededitionoftheLifeSafetyCodedonotapplyinaStateifCMSfindsthatafireandsafetycodeimposedbyStatelawadequatelyprotectspatientsinhospices.
(4)Notwithstandinganyprovisionsofthe2000editionoftheLifeSafetyCodetothecontrary,ahospicemayplacealcohol-basedhandrubdispensersinitsfacilityif--(i)Useofalcohol-basedhandrubdispensersdoesnotconflictwithanyStateorlocalcodesthatprohibitorotherwiserestricttheplacementofalcohol-basedhandrubdispensersinhealthcarefacilities;(ii)Thedispensersareinstalledinamannerthatminimizesleaksandspillsthatcouldleadtofalls;(iii)Thedispensersareinstalledinamannerthatadequatelyprotectsagainstaccessbyvulnerablepopulations;and(iv)Thedispensersareinstalledinaccordancewithchapter18.
3.
2.
7orchapter19.
3.
2.
7ofthe2000editionoftheLifeSafetyCode,asamendedbyNFPATemporaryInterimAmendment00-1(101),issuedbytheStandardsCounciloftheNationalFireProtectionAssociationonApril15,2004.
TheDirectoroftheOfficeoftheFederalRegisterhasapprovedNFPATemporaryInterimAmendment00-1(101)forincorporationbyreferenceinaccordancewith5U.
S.
C.
552(a)and1C.
F.
R.
part51.
AcopyofthecodeisavailableforinspectionattheCMSInformationResourceCenter,7500SecurityBoulevard,Baltimore,MDorattheNationalArchivesandRecordsAdministration(NARA).
ForinformationontheavailabilityofthismaterialatNARA,call202-741-6030,orgoto:http://www.
archives.
gov/federalregister/codeoffederalregulations/ibrlocations.
html.
CopiesmaybeobtainedfromtheNationalFireProtectionAssociation,1BatterymarchPark,Quincy,MA02269.
IfanychangesintheeditionoftheCodeareincorporatedbyreference,CMSwillpublishanoticeintheFederalRegistertoannouncethechanges.
ProceduresandProbes§418.
110(d)IstheredocumentationofcompliancewithanyStateand/orFederalbuildingregulationscodes,suchasthe2000editionoftheLifeSafetyCode(LSC).
NOTE:TheLSCisnotapplicablewhereCMSfindsthataStatehasineffectafireandsafetycodeimposedbyStatelawthatadequatelyprotectspatientsinhealthcarefacilities.
Requesttoseeevidencethatfire/safetydrillshavebeenheldonallshiftsatvariedtimesasrequiredbytheLifeSafetyCode.
Wheredoesthehospicedocumentandstoreitsdated,writtenreport,andevaluationofeachdrillRequestevidenceofthelatestchecksoffireextinguishers,sprinklersystems,andsmokealarms.
Doesapreventivemaintenanceprogramexistforelectrical,HVAC(heat,ventilationandairconditioner),sprinkler,andsecuritysystemsObservethelocationoffireextinguishers.
AretherefunctionalsmokealarmsineachpatientroomL729(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(e)Standard:Patientareas.
Thehospicemustprovideahome-likeatmosphereandensurethatpatientareasaredesignedtopreservethedignity,comfort,andprivacyofpatients.
(1)Thehospicemustprovide—(i)Physicalspaceforprivatepatientandfamilyvisiting;(ii)Accommodationsforfamilymemberstoremainwiththepatientthroughoutthenight;and(iii)Physicalspaceforfamilyprivacyafterapatient'sdeath.
(2)Thehospicemustprovidetheopportunityforpatientstoreceivevisitorsatanyhour,includinginfantsandsmallchildren.
InterpretiveGuidelines§418.
110(e)Ahomelikeatmospherede-emphasizestheinstitutionalcharacterofthesettingtotheextentpossible.
Procedures§418.
110(e)Interviewpatients/familymemberstovalidatethatvisitinghoursarenotrestrictedandaccommodationsareprovidedforfamilymemberstostaywiththepatientduringthenight.
Observethepatientareasfortheaboverequirements.
Arewindowtreatmentsandfloorcoveringsresidential/homelikeinappearanceanddesignL730(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(f)Standard:Patientrooms.
(1)Thehospicemustensurethatpatientroomsaredesignedandequippedfornursingcare,aswellasthedignity,comfort,andprivacyofpatients.
(2)Thehospicemustaccommodateapatientandfamilyrequestforasingleroomwheneverpossible.
(3)Eachpatient'sroommust—(i)Beatorabovegradelevel;(ii)Containasuitablebedandotherappropriatefurnitureforeachpatient;(iii)Haveclosetspacethatprovidessecurityandprivacyforclothingandpersonalbelongings;(iv)Accommodatenomorethantwopatientsandtheirfamilymembers;(v)Provideatleast80squarefeetforeachresidingpatientinadoubleroomandatleast100squarefeetforeachpatientresidinginasingleroom;and(vi)Beequippedwithaneasily-activated,functioningdeviceaccessibletothepatient,thatisusedforcallingforassistance.
(4)ForafacilityoccupiedbyaMedicare-participatinghospiceonDecember2,2008,CMSmaywaivethespaceandoccupancyrequirementsofparagraphs(f)(2)(iv)and(f)(2)(v)ofthissectionifitdeterminesthat—(i)Impositionoftherequirementswouldresultinunreasonablehardshiponthehospiceifstrictlyenforced;orjeopardizeitsabilitytocontinuetoparticipateintheMedicareprogram;and(ii)Thewaiverservestheneedsofthepatientanddoesnotadverselyaffecttheirhealthandsafety.
InterpretiveGuidelines§418.
110(f)Inadditiontoaclean,comfortablebed,eachpatientshouldhaveatleastaplacetoputpersonaleffects,suchaspicturesandaclock,furnituresuitableforthecomfortofthepatientandvisitors(i.
e.
,achair)andadequatelightingsuitabletothetasksthepatientchoosestoperform,ortheinpatientstaffneedstoperform.
WaiverrequestsmentionedinthisrequirementmustbesubmittedinwritingtotheCMSRO.
Probes§418.
110(f)Doeseachbedhaveaflameretardantcubiclecurtains,movablescreens,orotheracceptablemeansofprovidingfullvisualprivacyL731(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(g)Standard:Toiletandbathingfacilities.
Eachpatientroommustbeequippedwith,orconvenientlylocatednear,toiletandbathingfacilities.
InterpretiveGuidelines418.
110(g)―Toiletfacilities‖meansaspacethatcontainsalavatoryandatoilet.
Assurethateachfloorhasatleastonetoiletfacilityandshowerstalllargeenoughtoaccommodateawheelchairandpatienttransfer.
L732(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(h)Standard:Plumbingfacilities.
Thehospicemust—(1)Haveanadequatesupplyofhotwateratalltimes;and(3)Haveplumbingfixtureswithcontrolvalvesthatautomaticallyregulatethetemperatureofthehotwaterusedbypatients.
InterpretiveGuidelines§418.
110(h)Theintentofthisregulationisthatthetemperatureofwateratfixturesandinshowersandtubsusedbypatientsshallbeautomaticallyregulatedbycontrolvalvesanddeliveredforuseattheappropriatetemperature.
Thereisariskthatpatientsorstaffmaybescaldedbyexcessivelyhotwaterdischargedbyplumbingfixtures.
Waterthatistoohotmayscaldindividualswhoareexposedtoit.
Thisdangerisparticularlysignificantforpatientswhomayhavecirculatoryorotherneurologicaldeficitsthatpreventtheinstantaneousrecoilfromwaterthatistoohot.
Thechartbelowshowstheestimatedtimeforpersonstoreceivesecondandthirddegreeburnsatvarioustemperatures.
WaterTemperatureTimetoReceiveSecondDegreeBurnTimetoReceiveThirdDegreeBurn120degrees8minutes10minutes124degrees2minutes4minutes131degrees17seconds30seconds140degrees3seconds5seconds150degrees<1second1secondTherecommendedwatertemperaturesattheplumbingfixturesshouldbemaintainedatorbelow110degrees.
ProceduresandProbes§418.
110(h)Interviewstaffandpatientstoassurethereisalwaysanadequatesupplyofhotwaterontheunit.
Requestincidentreportsforthepast12months.
Hastherebeenanydocumentationofanincident(s)relatedtopatientscaldingwithwaterAskthehospicetoprovidethemaintenancelogsfortheautomaticcontrolvalvesusedtoregulatethetemperatureofthehotwater.
Reviewthewatertemperaturesrecorded.
Checkthehotwatertemperaturesatpatientssinks,showersandtubstoverifythatthewatertemperaturedoesnotexceedsafebathingtemperature.
Howtotestwatertemperatures:1.
Followthethermometermanufacturersrecommendedinstructionsforuse.
2.
Measurethehotwatertemperaturepriortoheavyuse,oratleastonehourafter,sothehotwaterheaterhastimetorecoverandheattoitssettemperature.
3.
Toensureaccuracy,donotholdthethermometerundertherunningwatertomeasurethetemperature.
4.
Allowthehotwatertorunforasufficientamountoftimetoensurethewaterisatitshottesttemperature.
5.
Fillabowlorcupwithhotwater.
6.
Immediatelyimmersethesilverendofthethermometercompletelyintothecontainedwater.
7.
Keepthethermometerinthewateruntilthemeasurementhasstabilized(30to60seconds),thenreadthetemperature.
L733(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(i)Standard:Infectioncontrol.
Thehospicemustmaintainaninfectioncontrolprogramthatprotectspatients,staffandothersbypreventingandcontrollinginfectionsandcommunicablediseaseasstipulatedin§418.
60.
InterpretiveGuidelines§418.
110(i)Thehospiceinpatientfacilitymusthaveanactivesurveillanceprogramthatincludesspecificmeasuresforprevention,earlydetection,control,education,andinvestigationofinfectionsandcommunicablediseasesinthehospice.
Theremustbeamechanismtoevaluatetheeffectivenessoftheprogram(s)andtakecorrectiveactionwhennecessary.
Theprogrammustincludeimplementationofnationallyrecognizedsystemsofinfectioncontrolguidelinestoavoidsourcesandtransmissionofinfectionsandcommunicablediseases(e.
g.
,theCDCGuidelinesforPreventionandControlofNosocomialInfections,theCDCGuidelinesforPreventingtheTransmissionofTuberculosisinHealthCareFacilities,OSHAregulations,andAPICguidelinesoninfectioncontrol,etc.
).
Reviewdiseasereportingproceduresandevidenceofsystematictrackingofcommunicableandreportablediseases.
IsthisprogrampartofthehospicesoverallqualityassessmentandperformanceimprovementandeducationprogramInterviewmanagementandstafftodetermineiftheyareawareoftheproceduretobefollowedifapatientorstaffcontractsaninfectiousorcommunicabledisease.
Determineiftherehavebeenahighnumberofinfectionsunrelatedtothepatientsdiagnosis.
Ifidentified,whatwerethehospicesresponseandactionstopreventtheseandfutureoccurrencesTheactiveinfectioncontrolprogramshouldhavepoliciesthataddressthefollowing:Definitionofnosocomialinfectionsandcommunicablediseases;Measuresforidentifying,investigating,andreportingnosocomialinfectionsandcommunicablediseases;Measuresforassessingandidentifyingpatientsandhealthcareworkers,includinghospicepersonnel,contractstaff(e.
g.
,agencynurses,housekeepingstaff)andvolunteers,atriskforinfectionsandcommunicablediseases;Measuresforthepreventionofinfections;Measuresforpreventionofcommunicablediseaseoutbreaks,suchasairbornediseases(TB,SARS,etc.
),foodbornediseases(HepatitisA,Salmonella,etc.
),bloodbornediseases(HIV,HepatitisB,etc.
),andothers(VRE,MRSA,pseudomonas,etc.
);Provisionofasafeenvironmentconsistentwithnationallyrecognizedinfectioncontrolprecautions,suchasthecurrentCDCrecommendationsfortheidentifiedinfectionand/orcommunicabledisease;IsolationproceduresandrequirementsforinfectedorimmunosuppressedpatientsUseandtechniquesforstandardprecautions;Educationofpatients,familymembersandcaregiversaboutinfectionsandcommunicablediseases;Techniquesforhandwashing,respiratoryprotections,asepsisaswellasothermeansforlimitingthespreadofcontagion;Orientationofallnewhospicepersonneltoinfections,communicablediseases,andtotheinfectioncontrolprogram;Measuresforthescreeningandevaluationofhealthcareworkers,includingallhospicestaff,contractworkers(e.
g.
,agencynurses,housekeepingstaff,etc),andvolunteers,forcommunicablediseases,andfortheevaluationofstaffandvolunteersexposedtopatientswithnon-treatedcommunicablediseases;andEmployeehealthpoliciesregardinginfectiousdiseasesandwheninfectedorillemployees,includingcontractworkersandvolunteers,mustnotrenderpatientcareand/ormustnotreporttowork.
L734(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(j)Standard:SanitaryenvironmentThehospicemustprovideasanitaryenvironmentbyfollowingcurrentstandardsofpractice,includingnationallyrecognizedinfectioncontrolprecautions,andavoidsourcesandtransmissionofinfectionsandcommunicablediseases.
InterpretiveGuidelines§418.
110(j)"Sanitary"includes,butisnotlimitedto,preventingthespreadofdisease-causingorganismsbykeepingpatientcareequipmentcleanandproperlystored.
Patientcareequipmentincludes,butisnotlimitedto,toothbrushes,dentures,denturecups,glasses,waterpitchers,emesisbasins,hairbrushes,combs,bedpans,urinals,andpositioningorassistivedevices.
ProceduresandProbes§418.
110(j)Askthehospicetodescribehowtheykeepthefacilitycleanandsanitary.
Observestaffprovidingcare.
DotheyfollowacceptableinfectioncontrolguidelinesObservetheinpatientunits–dotheyappearcleanL735(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(k)Standard:Linen.
Thehospicemusthaveavailableatalltimesaquantityofcleanlineninsufficientamountsforallpatientuses.
Linensmustbehandled,stored,processed,andtransportedinsuchamannerastopreventthespreadofcontaminants.
ProceduresandProbes§418.
110(k)Interviewpatients/familiestodetermineiflinensarepromptlychangedwhensoiledthroughoutall24-hourperiods,includingweekendsandholidays.
AskmanagementwhatthehospicespolicyisonthefrequencyoflinenchangeandreplacementDuringatouroftheinpatienthospiceunit,observepatientbeddingtoassurecleanliness.
Requesttoseethelinenstorageareatodetermineifthereisanadequatesupplytomeetongoingpatientneeds.
Howdoesthehospicestorethecleanlinentokeepitclean,dry,anddustfreeIssoiledlinenandclothingcollectedandenclosedinsuitablebagsorcontainersinwell-ventilatedareas,separatefromcleanlinenandnotpermittedtoaccumulateinthefacilityL736(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(l)Standard:Mealserviceandmenuplanning.
Thehospicemustfurnishmealstoeachpatientthatare—(1)Consistentwiththepatient'splanofcare,nutritionalneeds,andtherapeuticdiet;(2)Palatable,attractive,andservedatthepropertemperature;and(3)Obtained,stored,prepared,distributed,andservedundersanitaryconditions.
InterpretiveGuidelines§418.
110(l)Theintentofthisregulationistoassurethatthenutritivevalueoffoodisnotcompromisedanddestroyedbecauseofprolongedfoodstorage,light,andairexposure.
Foodshouldbepalatable,attractive,andservedatthepropertemperatureasdeterminedbythetypeoffood.
Food-palatabilityreferstothetasteand/orflavorofthefood.
Foodattractivenessreferstotheappearanceofthefoodwhenserved.
Foodtemperatureisfoodservedatpreferabletemperature(hotfoodsareservedhotandcoldfoodsareservedcold)asdiscernedbythepatientandcustomarypractice.
ProceduresandProbes§418.
110(l)Evidenceforpalatabilityandattractivenessoffood,fromdaytodayandmealtomeal,maybestrengthenedthroughsourcessuchas:observation,patient,familyandstaffinterviews.
Attempttovisittheinpatientunitwhilemealsaredeliveredandobserveifvolunteersorstaffareavailabletoassistpatientswhoneedhelp.
HowdoesthehospicemeettheindividualpatientsnutritionalneedsasidentifiedintheplanofcareWhatarrangementsdoesthehospicehavetoservemealsatthepropertemperatureandinaformthatmeetsthepatientsneedsanddesiresIsfoodservedatpreferabletemperature(hotfoodsareservedhotandcoldfoodsareservedcold)asdiscernedbythepatientandcustomarypracticeHowistheIDGkeptinformedofthepatientsresponsetotheprescribeddietAremealsindividuallyscheduled,ifneeded,toallowforfrequent,smallmealsifsodesiredbythepatientIsfoodavailable24hoursaday,sevendaysaweek,torespondtothepatientsrequestsandneedsL737(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)Standard:Restraintorseclusion.
Allpatientshavetherighttobefreefromphysicalormentalabuse,andcorporalpunishment.
Allpatientshavetherighttobefreefromrestraintorseclusion,ofanyform,imposedasameansofcoercion,discipline,convenience,orretaliationbystaff.
Restraintorseclusionmayonlybeimposedtoensuretheimmediatephysicalsafetyofthepatient,astaffmember,orothersandmustbediscontinuedattheearliestpossibletime.
InterpretiveGuidelines§418.
110(m)Thehospiceisresponsibleforcreatingaculturethatsupportsapatientsrighttobefreefromrestraintorseclusion.
Thehospicemustalsoensurethatsystemsandprocessesaredeveloped,implemented,andevaluatedthatsupportthepatientsrightsaddressedinthisstandard,andthateliminatetheinappropriateuseofrestraintorseclusion.
Ifrestraintsorseclusionisnecessarywithintheparametersofthisregulation,itmustbediscontinuedassoonaspossiblebasedonanindividualizedpatientassessmentandre-evaluation.
Aviolationofanyofthesepatientsrightsconstitutesaninappropriateuseofrestraintorseclusionandwouldbesubjecttoaconditionleveldeficiency.
Theuseofrestraintsforthepreventionoffallsmustnotbeconsideredaroutinepartofafallspreventionprogram.
Althoughrestraintshavebeentraditionallyusedasafallspreventionapproach,theyhavemajor,seriousdrawbacksandcancontributetoseriousinjuries.
Thereisnoevidencethattheuseofphysicalrestraint,(including,butnotlimitedto,raisedsiderails)willpreventorreducefalls.
Additionally,fallsthatoccurwhileapersonisphysicallyrestrainedoftenresultinmoresevereinjuriesand/ordeath.
L738(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(1)-Restraintorseclusionmayonlybeusedwhenlessrestrictiveinterventionshavebeendeterminedtobeineffectivetoprotectthepatient,astaffmember,orothersfromharm.
L739(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(2)-Thetypeortechniqueofrestraintorseclusionusedmustbetheleastrestrictiveinterventionthatwillbeeffectivetoprotectthepatient,astaffmember,orothersfromharm.
L740(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(3)-Theuseofrestraintorseclusionmustbe--(i)Inaccordancewithawrittenmodificationtothepatient'splanofcare;and(ii)ImplementedinaccordancewithsafeandappropriaterestraintandseclusiontechniquesasdeterminedbyhospicepolicyinaccordancewithStatelaw.
L741(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(4)-TheuseofrestraintorseclusionmustbeinaccordancewiththeorderofaphysicianauthorizedtoorderrestraintorseclusionbyhospicepolicyinaccordancewithStatelaw.
L742(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(5)-Ordersfortheuseofrestraintorseclusionmustneverbewrittenasastandingorderoronanasneededbasis(PRN).
InterpretiveGuidelines§418.
110(m)(5)ThisregulationprohibitstheuseofstandingorPRN(Latinabbreviationforprorenata-asneeded;ascircumstancesrequire)ordersfortheuseofrestraintorseclusion.
Theongoingauthorizationofrestraintorseclusionisnotpermitted.
Eachepisodeofrestraintorseclusionmustbeinitiatedinaccordancewiththeorderofaphysician.
Ifapatientwasrecentlyreleasedfromrestraintorseclusion,andexhibitsbehaviorthatcanonlybehandledthroughthereapplicationofrestraintorseclusion,aneworderwouldberequired.
Staffcannotdiscontinuearestraintorseclusionintervention,andthenre-startitunderthesameorder.
ThiswouldconstituteaPRNorder.
L743(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(6)-Themedicaldirectororphysiciandesigneemustbeconsultedassoonaspossibleiftheattendingphysiciandidnotordertherestraintorseclusion.
L744(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(7)-UnlesssupersededbyStatelawthatismorerestrictive—(i)Eachorderforrestraintorseclusionusedforthemanagementofviolentorself-destructivebehaviorthatjeopardizestheimmediatephysicalsafetyofthepatient,astaffmember,orothersmayonlyberenewedinaccordancewiththefollowinglimitsforuptoatotalof24hours:(A)4hoursforadults18yearsofageorolder;(B)2hoursforchildrenandadolescents9to17yearsofage;or(C)1hourforchildrenunder9yearsofage;andAfter24hours,beforewritinganeworderfortheuseofrestraintorseclusionforthemanagementofviolentorself-destructivebehavior,aphysicianauthorizedtoorderrestraintorseclusionbyhospicepolicyinaccordancewithStatelawmustseeandassessthepatient.
(ii)Eachorderforrestraintusedtoensurethephysicalsafetyofthenon-violentornon-self-destructivepatientmayberenewedasauthorizedbyhospicepolicy.
L745(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(8)-Restraintorseclusionmustbediscontinuedattheearliestpossibletime,regardlessofthelengthoftimeidentifiedintheorder.
L746(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(9)-Theconditionofthepatientwhoisrestrainedorsecludedmustbemonitoredbyaphysicianortrainedstaffthathavecompletedthetrainingcriteriaspecifiedinparagraph(n)ofthissectionatanintervaldeterminedbyhospicepolicy.
L747(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(10)-Physician,includingattendingphysician,trainingrequirementsmustbespecifiedinhospicepolicy.
Ataminimum,physiciansandattendingphysiciansauthorizedtoorderrestraintorseclusionbyhospicepolicyinaccordancewithStatelawmusthaveaworkingknowledgeofhospicepolicyregardingtheuseofrestraintorseclusion.
L748(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(11)Whenrestraintorseclusionisusedforthemanagementofviolentorself-destructivebehaviorthatjeopardizestheimmediatephysicalsafetyofthepatient,astaffmember,orothers,thepatientmustbeseenface-to-facewithin1houraftertheinitiationoftheintervention--(i)Bya—(A)Physician;or(B)Registerednursewhohasbeentrainedinaccordancewiththerequirementsspecifiedinparagraph(n)ofthissection.
(ii)Toevaluate—(A)Thepatient'simmediatesituation;(B)Thepatient'sreactiontotheintervention;(C)Thepatient'smedicalandbehavioralcondition;and(D)Theneedtocontinueorterminatetherestraintorseclusion.
L749(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(12)-Statesarefreetohaverequirementsbystatuteorregulationthataremorerestrictivethanthosecontainedinparagraph(m)(11)(i)ofthissection.
L750(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(13)-Iftheface-to-faceevaluationspecifiedin§418.
110(m)(11)isconductedbyatrainedregisterednurse,thetrainedregisterednursemustconsultthemedicaldirectororphysiciandesigneeassoonaspossibleafterthecompletionofthe1-hourface-to-faceevaluation.
L751(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(14)-Allrequirementsspecifiedunderthisparagraphareapplicabletothesimultaneoususeofrestraintandseclusion.
Simultaneousrestraintandseclusionuseisonlypermittedifthepatientiscontinuallymonitored--(i)Face-to-facebyanassigned,trainedstaffmember;or(ii)Bytrainedstaffusingbothvideoandaudioequipment.
Thismonitoringmustbeincloseproximitytothepatient.
L752(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(m)(15)-Whenrestraintorseclusionisused,theremustbedocumentationinthepatient'sclinicalrecordofthefollowing:(i)The1-hourface-to-facemedicalandbehavioralevaluationifrestraintorseclusionisusedtomanageviolentorself-destructivebehavior;(ii)Adescriptionofthepatient'sbehaviorandtheinterventionused;(iii)Alternativesorotherlessrestrictiveinterventionsattempted(asapplicable);(iv)Thepatient'sconditionorsymptom(s)thatwarrantedtheuseoftherestraintorseclusion;andthepatient'sresponsetotheintervention(s)used,includingtherationaleforcontinueduseoftheintervention.
L753(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(n)Standard:RestraintorseclusionstafftrainingrequirementsThepatienthastherighttosafeimplementationofrestraintorseclusionbytrainedstaff.
L754(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(n)(1)-Trainingintervals.
Allpatientcarestaffworkinginthehospiceinpatientfacilitymustbetrainedandabletodemonstratecompetencyintheapplicationofrestraints,implementationofseclusion,monitoring,assessment,andprovidingcareforapatientinrestraintorseclusion—(i)Beforeperforminganyoftheactionsspecifiedinthisparagraph;(ii)Aspartoforientation;and(iii)Subsequentlyonaperiodicbasisconsistentwithhospicepolicy.
InterpretiveGuidelines§418.
110(n)(1)Allstaffdesignatedbythehospiceashavingdirectpatientcareresponsibilities,includingcontractoragencypersonnel,mustdemonstratethecompetenciesspecifiedinstandard(n)priortoparticipatingintheapplicationofrestraints,implementationofseclusion,monitoring,assessment,orcareofapatientinrestraintorseclusion.
Thesecompetenciesmustbedemonstratedinitiallyaspartofhospiceorientationandsubsequentlyonaperiodicbasisconsistentwithhospicepolicy.
Hospiceshavetheflexibilitytoidentifyatimeframeforongoingtrainingbasedonthelevelofstaffcompetency,andtheneedsofthepatientpopulation(s)served.
Allstaffworkinginahospicethatprecludestheuseofrestraintsorseclusionwouldnothavetobetrainedordemonstratecompetenciesspecifiedinthisstandardsincenostaffinarestraintfreefacilitywouldbeapplyingrestraintsorplacingpatientsinseclusion.
Inthissituation,thehospiceshouldensurethatallstaffareawareofitsrestraintandseclusionfreephilosophyandprovideongoingtraininginthisphilosophy.
Thehospiceshouldalsocloselymonitorpatientstobesurethattheuseofanyrestraintorseclusiontechniqueisnotused.
L755(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(n)(2)Trainingcontent.
-Thehospicemustrequireappropriatestafftohaveeducation,training,anddemonstratedknowledgebasedonthespecificneedsofthepatientpopulationinatleastthefollowing:(i)Techniquestoidentifystaffandpatientbehaviors,events,andenvironmentalfactorsthatmaytriggercircumstancesthatrequiretheuseofarestraintorseclusion.
(ii)Theuseofnonphysicalinterventionskills.
(iii)Choosingtheleastrestrictiveinterventionbasedonanindividualizedassessmentofthepatient'smedical,orbehavioralstatusorcondition.
(iv)Thesafeapplicationanduseofalltypesofrestraintorseclusionusedinthehospice,includingtraininginhowtorecognizeandrespondtosignsofphysicalandpsychologicaldistress(forexample,positionalasphyxia).
(v)Clinicalidentificationofspecificbehavioralchangesthatindicatethatrestraintorseclusionisnolongernecessary.
(vi)Monitoringthephysicalandpsychologicalwell-beingofthepatientwhoisrestrainedorsecluded,includingbutnotlimitedto,respiratoryandcirculatorystatus,skinintegrity,vitalsigns,andanyspecialrequirementsspecifiedbyhospicepolicyassociatedwiththe1-hourface-to-faceevaluation.
(vii)Theuseoffirstaidtechniquesandcertificationintheuseofcardiopulmonaryresuscitation,includingrequiredperiodicrecertification.
InterpretiveGuidelines§418.
110(n)(2)Theterm"appropriatestaff"includesallstaffthatapplyrestraintorseclusion,monitor,assess,orotherwiseprovidecareforpatientsinrestraintorseclusion.
Staffneedstobeabletoemployabroadrangeofclinicalinterventionstomaintainthesafetyofthepatientandothers.
Thehospiceisexpectedtoprovideeducationandtrainingattheappropriatelevel,totheappropriatestaff,baseduponthespecificneedsofthepatientpopulation(s)beingserved.
L756(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(n)(3)-Trainerrequirements.
Individualsprovidingstafftrainingmustbequalifiedasevidencedbyeducation,training,andexperienceintechniquesusedtoaddresspatients'behaviors.
InterpretiveGuidelines§418.
110(n)(3)Hospicesmaydevelopandimplementtheirowntrainingprogramsoruseanoutsidetrainingprogram.
Interviewmanagementandreviewdocumentationtoassurethecoursetrainerhastheappropriatequalifications.
L757(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(n)(4)-Trainingdocumentation.
Thehospicemustdocumentinthestaffpersonnelrecordsthatthetraininganddemonstrationofcompetencyweresuccessfullycompleted.
ProceduresandProbes§418.
110(n)(4)Requestacopyofthetrainingcurriculumfortheuseofrestraintsorseclusion.
DoesitcontainalltherequiredcontentitemsasprescribedinthisStandardRequestacopyofnewemployeeorientationcontenttoassurethatinformationonuseofrestraintsorseclusionisincluded.
Reviewattendancesheetsforinitialandperiodictrainingsessions.
Review3newemployee(hiredwithinthepast12months)personnelfilestoassurethereisevidenceofappropriatetraininginrestraintandseclusionuse.
Conductaninterviewwiththeactualtrainerifadditionalvalidationisneeded.
L758(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
110(o)Standard:Deathreportingrequirements.
Hospicesmustreportdeathsassociatedwiththeuseofseclusionorrestraint.
(1)ThehospicemustreportthefollowinginformationtoCMS:(i)Eachunexpecteddeaththatoccurswhileapatientisinrestraintorseclusion.
(ii)Eachunexpecteddeaththatoccurswithin24hoursafterthepatienthasbeenremovedfromrestraintorseclusion.
(iii)Eachdeathknowntothehospicethatoccurswithin1weekafterrestraintorseclusionwhereitisreasonabletoassumethatuseofrestraintorplacementinseclusioncontributeddirectlyorindirectlytoapatient'sdeath.
"Reasonabletoassume"inthiscontextincludes,butisnotlimitedto,deathsrelatedtorestrictionsofmovementforprolongedperiodsoftime,ordeathrelatedtochestcompression,restrictionofbreathingorasphyxiation.
(2)EachdeathreferencedinthisparagraphmustbereportedtoCMSbytelephonenolaterthanthecloseofbusinessthenextbusinessdayfollowingknowledgeofthepatient'sdeath.
(3)Staffmustdocumentinthepatient'sclinicalrecordthedateandtimethedeathwasreportedtoCMS.
InterpretiveGuidelines§418.
110(o)Ifapatienthasanunexpecteddeaththatoccurswhileinrestraintorseclusion,oranunexpecteddeathoccurswithin24hoursafterrestraintorseclusionhasbeendiscontinued,thedeathmustbereportedtoCMSRO.
Additionally,ifadeathoccurswithinoneweekaftertheuseofrestraintorseclusionanditisreasonabletoassumethedeathwasassociatedwithrestraintand/orseclusion,thedeathshouldbereportedtoCMSRO.
Restraintmeans:(1)Anymanualmethod,physicalormechanicaldevice,material,orequipmentthatimmobilizesorreducestheabilityofapatienttomovehisorherarms,legs,body,orheadfreely,notincludingdevices,suchasorthopedicallyprescribeddevices,surgicaldressingsorbandages,protectivehelmets,orothermethodsthatinvolvethephysicalholdingofapatientforthepurposeofconductingroutinephysicalexaminationsortests,ortoprotectthepatientfromfallingoutofbed,ortopermitthepatienttoparticipateinactivitieswithouttheriskofphysicalharm(thisdoesnotincludeaphysicalescort);or(2)Adrugormedicationwhenitisusedasarestrictiontomanagethepatientsbehaviororrestrictthepatientsfreedomofmovementandisnotastandardtreatmentordosageforthepatientscondition.
Seclusionmeans:theinvoluntaryconfinementofapatientaloneinaroomoranareafromwhichthepatientisphysicallypreventedfromleaving.
Patientswhorequestprivateroomswouldnotbeconsideredinseclusion.
ProceduresandProbes§418.
110(o)DoestheinpatienthospicepolicyrelatedtotheuseofrestraintsorseclusionincludeinformationonreportingtoCMSintheeventofadeathconnectedtotheuseofrestraintsorseclusionInterviewmanagementandstafftoassessifanydeathshaveoccurredrelatedtotheuseofseclusionorrestraint.
Reviewanydocumentation/clinicalrecordsifsuchadeathhasoccurred.
WasthisinformationreportedappropriatelytoCMSwithinthetimeframerequiredbythisStandardL759(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112Conditionofparticipation:HospicesthatprovidehospicecaretoresidentsofaSNF/NForICF/MR.
L760(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112-Inadditiontomeetingtheconditionsofparticipationat§418.
10through§418.
116,ahospicethatprovideshospicecaretoresidentsofaSNF/NForICF/MRmustabidebythefollowingadditionalstandards.
InterpretiveGuidelines§418.
112Forthepurposesofthisguidanceunderthiscondition,"facility"willbeusedinplaceofSNF/NForICF/MR.
Allreferencestoa"patient"intheguidanceunderthisconditionmeanapersonwhoisaresidentofafacilityandisreceivinghospiceservicesfromtheMedicarecertifiedhospice.
L761(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(a)Standard:Residenteligibility,election,anddurationofbenefits.
MedicarepatientsreceivinghospiceservicesandresidinginaSNF,NF,orICF/MRaresubjecttotheMedicarehospiceeligibilitycriteriasetoutat§418.
20through§418.
30.
L762(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(b)Standard:Professionalmanagement.
Thehospicemustassumeresponsibilityforprofessionalmanagementoftheresident'shospiceservicesprovided,inaccordancewiththehospiceplanofcareandthehospiceconditionsofparticipation,andmakeanyarrangementsnecessaryforhospice-relatedinpatientcareinaparticipatingMedicare/Medicaidfacilityaccordingto§418.
100and§418.
108.
InterpretiveGuidelines§418.
112(b)Theterm"professionalmanagement"forahospicepatientwhoresidesinaSNF/NForICF/MRhasthesamemeaningthatithasifthehospicepatientwerelivinginhis/herownhome.
Professionalmanagementinvolvesassessing,planning,monitoring,directingandevaluatingthepatients/residentshospicecareacrossallsettings.
Theprofessionalservicesprovidedbythehospicetothepatientinhis/herhomeshouldcontinuetobeprovidedbythehospicetothepatientinafacility,orotherplaceofresidence.
Hospicecoreservicesmustberoutinelyprovidedbythehospice,andcannotbedelegatedtothefacility.
Hospicesshouldspecifythatfacilitystaffshouldimmediatelynotifythehospiceoftheseunplannedinterventions.
Inthecontractbetweenthehospiceandthefacility,potentialcrisissituationsandtemporaryemergencymeasuresshouldbeaddressedanddeterminedhowtheywillbehandledbyfacilitystaff.
Hospiceisresponsibleforprovidingallhospiceservicesincluding:Ongoingassessment,careplanning,monitoring,coordination,andprovisionofcarebytheHospiceIDG.
Assessment,coordination,andprovisionofanyneededgeneralinpatientorcontinuouscare.
Consultationaboutthepatientscarewithfacilitystaff.
CoordinationbythehospiceRNfortheimplementationoftheplanofcareforthepatient.
Provisionofhospiceaideservices,iftheseservicesaredeterminednecessarybytheIDGtosupplementthenurseaideservicesprovidedbythefacility.
Provision,inatimelymanner,ofallsupplies,medications,andDMEneededforthepalliationandmanagementoftheterminalillnessandrelatedconditions.
Financialmanagementresponsibilityforallmedicalsupplies,appliances,medicationsandbiologicalsrelatedtotheterminalillnessandrelatedconditions.
Determinationoftheappropriatelevelofcaretobegiventothepatient(routinehomecare,inpatient,orcontinuouscare).
Arranginganynecessarytransfersfromthefacility,inconsultationwiththefacilitystaff.
L763(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)Standard:Writtenagreement.
ThehospiceandSNF/NForICF/MRmusthaveawrittenagreementthatspecifiestheprovisionofhospiceservicesinthefacility.
TheagreementmustbesignedbyauthorizedrepresentativesofthehospiceandtheSNF/NForICF/MRbeforetheprovisionofhospiceservices.
InterpretiveGuidelines§418.
112(c)Thewrittenagreementisfortheprovisionofhospiceservicesbetweenthetwoentities.
Asthewrittenagreementisnotpatientspecific,itdoesnotneedtoberewrittenforeachpatient.
Ifthereareconcernsregardingtheprovisionofservices,thehospiceandthefacilitymayreviewandrevisethisagreementasappropriateforneededchangesand/orimprovementintheworkingrelationshipbetweenthetwoentities.
L764(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)-Thewrittenagreementmustincludeatleastthefollowing:(1)ThemannerinwhichtheSNF/NForICF/MRandthehospicearetocommunicatewitheachotheranddocumentsuchcommunicationstoensurethattheneedsofpatientsareaddressedandmet24hoursaday.
InterpretiveGuidelines§418.
112(c)(1)Thereshouldbeevidencethatthehospiceandthefacilityhavereachedanagreementonhowtocommunicateconcernsandresponses24hoursadayinordertoworktogethertomeettheneedsofthepatientidentifiedinthepatientsplanofcare.
Thehospicemustdocumentthatthiscommunicationhasoccurred.
ProceduresandProbes§418.
112(c)(1)Whatsystemisinplacetoassurethatthefacilityknowshowtonotifythehospicewhennecessaryona24/7basisIsthereanyevidencethatthecommunicationisnotoccurringasneededduringvarioustimesofthedayorweekorspecificshiftsHowdoesthehospiceensurethatfacilitystaffareabletorecognizetheindividualswhoarereceivinghospiceservicesandknowthattheservicesprovidedtothispatientshouldbeinaccordancewiththecoordinatedplanofcareWhatevidenceistherethatthehospiceandthefacilitycommunicatewitheachotherduringandbetweenpatientvisits,asappropriate,toshareinformationaboutthepatientsneedsandresponsetotheplanofcareDoesthehospicestaffhaveaccesstoandtheabilitytocommunicatewithfacilitystaffaboutthepatientscareasoftenasneededL765(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)(2)-AprovisionthattheSNF/NForICF/MRimmediatelynotifiesthehospiceif—(i)Asignificantchangeinapatient'sphysical,mental,social,oremotionalstatusoccurs;(ii)Clinicalcomplicationsappearthatsuggestaneedtoaltertheplanofcare;(iii)AneedtotransferapatientfromtheSNF/NForICF/MRarises,andthehospicemakesarrangementsfor,andremainsresponsiblefor,anynecessarycontinuouscareorinpatientcarenecessaryrelatedtotheterminalillnessandrelatedconditions;or(iv)Apatientdies.
ProceduresandProbes§418.
112(c)(2)HavetherebeeninstanceswhenthefacilitytransferredapatienttothehospitalwithoutnotifyingthehospiceHavetherebeeninstanceswhenthehospicehasbeenunawareofasignificantchangeinthepatientsstatusordeathofahospicepatientHowdoesthehospiceensurethatfacilitystaffwillcontactthehospiceimmediatelyregardingtherequiredprovisions,includingbutnotlimitedto:–Anychangesinconditionsuchaschangesincognitionorsuddenunexpecteddeclineincondition;–Aconditionunrelatedtotheterminalconditionorrelatedconditions,suchasafallwithasuspectedfracture;–Complications,suchasadverseconsequencestoamedicationortherapy,requiringarevisiontotheplanofcare;and–Apatientsdeath.
L766(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)(3)-Aprovisionstatingthatthehospiceassumesresponsibilityfordeterminingtheappropriatecourseofhospicecare,includingthedeterminationtochangethelevelofservicesprovided.
ProceduresandProbes§418.
112(c)(3):IsthereevidencethatthepatientsarereceivingtheappropriatelevelofhospiceservicestomeettheirneedsDoeseachpatientreceiveupdatestothecomprehensiveassessmentattherequiredtimepointsaccordingto§418.
54(d)andplanofcarereviewsaccordingto§418.
56(d)L767(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)(4)-AnagreementthatitistheSNF/NForICF/MRresponsibilitytocontinuetofurnish24hourroomandboardcare,meetingthepersonalcareandnursingneedsthatwouldhavebeenprovidedbytheprimarycaregiverathomeatthesamelevelofcareprovidedbeforehospicecarewaselected.
InterpretiveGuidelines§418.
112(c)(4):Inenteringintoanagreementwitheachother,eachproviderretainsresponsibilityforthequalityandappropriatenessofthecareitprovidesinaccordancewiththeirrespectivelawsandregulations.
Bothprovidersmustcomplywiththeirapplicableconditions/requirementsforparticipationinMedicare/Medicaid.
Thefacilitysservicesmustbeconsistentwiththeplanofcaredevelopedincoordinationwiththehospice,(thehospicepatientresidinginafacilityshouldnotexperienceanylackofservicesorpersonalcarebecauseofhis/herstatusasahospicepatient);andthefacilitymustofferthesameservicestoitsresidentswhohaveelectedthehospicebenefitasitfurnishestoitsresidentswhohavenotelectedthehospicebenefit.
IfapatientisreceivingservicesfromaMedicare/MedicaidcertifiednursingfacilityorICF/MR,andthefacilitywasadvisedofconcernsbythehospiceandfailedtoaddressand/orresolveissuesrelatedtocoordinationofcareorimplementationofappropriateservices,thehospicesurveyorwillrefertheconcernsasacomplainttotheStateAgencyresponsibleforoversightofthefacilityidentifyingthespecificpatient(s)involvedandtheconcernsidentified.
L768(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)(5)-Anagreementthatitisthehospice'sresponsibilitytoprovideservicesatthesamelevelandtothesameextentasthoseserviceswouldbeprovidediftheSNF/NForICF/MRresidentwereinhisorherownhome.
InterpretiveGuidelines§418.
112(c)(5)Regardlessofwhereapatientresides,ahospiceiscontinuallyresponsibleforfurnishingcoreservices,andmaynotdelegatetheseservicestothefacilitystaff.
L769(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)(6)-Adelineationofthehospice'sresponsibilities,whichinclude,butarenotlimitedtothefollowing:providingmedicaldirectionandmanagementofthepatient;nursing;counseling(includingspiritual,dietaryandbereavement);socialwork;provisionofmedicalsupplies,durablemedicalequipmentanddrugsnecessaryforthepalliationofpainandsymptomsassociatedwiththeterminalillnessandrelatedconditions;andallotherhospiceservicesthatarenecessaryforthecareoftheresident'sterminalillnessandrelatedconditions.
InterpretiveGuidelines§418.
112(c)(6)Theagreementshouldidentifyhowthefacilityandthehospicedeterminehowallneededservices,professionals,medicalsupplies,DMEanddrugsandbiologicalsnecessaryforthepalliationandmanagementofpainandsymptomsassociatedwiththeterminalillnessandrelatedconditionsareavailabletothepatient24hoursaday,7daysaweek,includingwhomayreceiveand/orwriteordersforcare,inaccordancewithState/Federalrequirements.
Probe§418.
112(c)(6)Isthereevidencethatthehospiceprovidestheservicesasneeded,aswellasmedications,equipmentandsuppliesnecessaryforpaincontrolandsymptommanagementona24hourbasisL770(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)(7)-AprovisionthatthehospicemayusetheSNF/NForICF/MRnursingpersonnelwherepermittedbyStatelawandasspecifiedbytheSNF/NForICF/MRtoassistintheadministrationofprescribedtherapiesincludedintheplanofcareonlytotheextentthatthehospicewouldroutinelyusetheservicesofahospicepatient'sfamilyinimplementingtheplanofcare.
Probes§418.
112(c)(7)IsthereevidencethatfacilitypersonnelassistintheadministrationofprescribedtherapiesincludedintheplanofcarethatexceedwhatahospicefamilymembermightimplementHowdothehospiceandthefacilityidentifythetherapiesthatfacilitystaffwillbeallowedtoperformL771(Rev.
)§418.
112(c)(8)-Aprovisionstatingthatthehospicemustreportallallegedviolationsinvolvingmistreatment,neglect,orverbal,mental,sexual,andphysicalabuse,includinginjuriesofunknownsource,andmisappropriationofpatientpropertybyanyoneunrelatedtothehospicetotheSNF/NForICF/MRadministratorwithin24hoursofthehospicebecomingawareoftheallegedviolation.
L772(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(c)(9)-AdelineationoftheresponsibilitiesofthehospiceandtheSNF/NForICF/MRtoprovidebereavementservicestoSNF/NForICF/MRstaff.
InterpretiveGuidelines§418.
112(c)(9)Therearetimeswhenfacilitystaffandresidentsfulfilltheroleofapatientsfamily,providingcaregiverservices,beingcompanions,andgenerallysupportingthepatient.
Ahospicemayofferbereavementservicestofacilitystafforresidentsthatfulfilltheroleofahospicepatientsfamilyasidentifiedinthepatientsplanofcare.
L773(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(d)Standard:Hospiceplanofcare.
Inaccordancewith§418.
56,awrittenhospiceplanofcaremustbeestablishedandmaintainedinconsultationwithSNF/NForICF/MRrepresentatives.
Allhospicecareprovidedmustbeinaccordancewiththishospiceplanofcare.
L774(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(d)(1)-Thehospiceplanofcaremustidentifythecareandservicesthatareneededandspecificallyidentifywhichproviderisresponsibleforperformingtherespectivefunctionsthathavebeenagreeduponandincludedinthehospiceplanofcare.
L775(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(d)(2)-Thehospiceplanofcarereflectstheparticipationofthehospice,theSNF/NForICF/MR,andthepatientandfamilytotheextentpossible.
InterpretiveGuidelines§418.
112(d)(2)Thehospiceandthefacilitymustdevelopacoordinatedplanofcareforeachpatientthatguidesbothproviders.
Whenahospicepatientisaresidentofafacility,thatpatientshospiceplanofcaremustbeestablishedandmaintainedinconsultationwithrepresentativesofthefacilityandthepatient/family(totheextentpossible).
Thehospiceportionoftheplanofcaregovernstheactionsofthehospiceanddescribestheservicesthatareneededtocareforthepatient.
Inaddition,thecoordinatedplanofcaremustidentifywhichprovider(hospiceorfacility)isresponsibleforperformingaspecificservice.
Thecoordinatedplanofcaremaybedividedintotwoportions,oneofwhichismaintainedbythefacilityandtheother,whichismaintainedbythehospice.
ThefacilityisrequiredtoupdateitsplanofcareinaccordancewithanyFederal,Stateorlocallawsandregulationsgoverningtheparticularfacility,justashospicesneedtoupdatetheirplansofcareaccordingto§418.
56(d)oftheseCoPs.
Thehospiceplanofcaremustspecificallyidentify/delineatetheproviderresponsibleforeachfunction/service/interventionincludedintheplanofcare.
NOTE:Theprovidersmusthaveaprocedurethatclearlyoutlinesthechainofcommunicationbetweenthehospiceandfacilityintheeventacrisisoremergencydevelops,achangeofconditionoccurs,and/orchangestothehospiceportionoftheplanofcareareindicated.
Basedonthesharedcommunicationbetweenproviders,bothprovidersportionoftheplanofcareshouldreflecttheidentificationof:Acommonproblemlist;Palliativeinterventions;Palliativeoutcomes;Responsiblediscipline;Responsibleprovider;andPatientgoals.
ProceduresandProbes§418.
112(d)(2)Interviewthepatient,familyorrepresentativeifpossibletodeterminetheirinvolvementinthedevelopmentoftheplanofcare,definingtheapproachesandgoals,andtodetermineifinterventionsreflectchoicesandpreferences.
Also,determinehowtheyareinvolvedindevelopingandrevisingpainmanagementstrategies(ifany)andanynecessaryrevisionsiftheinterventionsdonotwork.
Determinewhethermedicationsorotherinterventionsforsymptomcontrol,medicalsuppliesorDMErelatedtotheterminalillnesshavebeenarrangedandprovidedbythehospice,andareavailableforpatientuse.
Determinewhethertherehavebeendelaysintheprovisionofmedicationsand/orsupplies/equipment,andhowthishasbeenaddressedbythehospiceandthefacility.
L776(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(d)(3)-Anychangesinthehospiceplanofcaremustbediscussedwiththepatientorrepresentative,andSNF/NForICF/MRrepresentatives,andmustbeapprovedbythehospicebeforeimplementation.
InterpretiveGuidelines§418.
112(d)(3)ThehospiceandthefacilitymusthaveaprocessinwhichtheycanexchangeinformationfromthehospiceIDGplanofcarereviewsandassessmentupdates,andthefacilityteam,patientandfamily(totheextentpossible)conferences,whenupdatingtheplanofcareandevaluatingoutcomesofcaretoassurethatthepatientreceivesthenecessarycareandservices.
Thehospicemustauthorizeallchangestothehospiceportionoftheplanofcarepriortothechangebeingmade.
ProceduresandProbes§418.
112(d)(3)Basedonobservations,ifconcernsareidentifiedthattheplanofcaredoesnotidentifytheinterventionsobserved,orifthepatientand/orrepresentativehaveindicatedthattheinterventionsarenotmeetinghis/herneeds,interviewhospiceandfacilitystaff.
Determinehowthehospiceandfacilitymonitorfortheoutcomeoftheinterventionsandwhatprocesstheyhaveinplacetorevisetheplanofcaretomeettheneedsofthepatient.
Determinehowthehospiceisprovidingcoordinationoftheplanofcareinterventions,assuringthattheinterventionsarebeingimplementedbythefacility,andassuringthatinterventionsarenotchangedwithouthospiceapproval.
L777(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(e)Standard:Coordinationofservices.
Thehospicemust:(1)DesignateamemberofeachinterdisciplinarygroupthatisresponsibleforapatientwhoisaresidentofaSNF/NForICF/MR.
Thedesignatedinterdisciplinarygroupmemberisresponsiblefor:L778(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(e)(1)(i)-ProvidingoverallcoordinationofthehospicecareoftheSNF/NForICF/MRresidentwithSNF/NForICF/MRrepresentatives;andInterpretiveGuidelines§418.
112(e)(1)(i)TheintentofthisregulationisforthehospiceIDGtodesignateamemberresponsibleforoverseeingandcoordinatingtheprovisionofcarebetweenthehospiceandthefacility.
ThispersonmayormaynotbethehospiceRNresponsibleforthecoordinationofpatientshospicecareinthefacility.
Itmayalsobethephysician,socialworkerorcounselormemberoftheIDG.
Inordertofacilitatethecoordinationandprovisionofhospicecaretothepatient,thehospiceandthefacilityshouldaddresshowthehospicestaffaccessandcommunicatewithfacilitystaff.
Thisincludes,butisnotlimitedto:Developmentofeachprovidersportionoftheplanofcaretoassurethattheplansarecomplimentaryandreflectcommongoalsandthepatientsexpresseddesireforhospicecare;Documentationinbothrespectiveentitiesclinicalrecordsorothermeanstoensurecontinuityofcommunicationandeasyaccesstoongoinginformation;Roleofanyhospicevendorindeliveringsuppliesormedications;Ordering,renewal,deliveryandadministrationofmedications;andRoleoftheattendingphysician,andprocessforobtainingandimplementingphysicianorders.
ProceduresandProbes§418.
112(e)(1)(i)Doesthehospicessystemforordering,renewal,deliveryandadministrationofmedicationsworkeffectivelyinthefacilityWhatproceduresareinplacetoensurethatthepatientreceivestimelymedicationandtreatmentsforoptimalpalliation,painandsymptomreliefIsthereevidencethatthehospiceprovideseducationtothefacilityonthehospiceresidentspainandsymptommanagementplanDoesthehospiceworkwiththefacilitytomonitortheeffectivenessoftreatmentsrelatedtopainandsymptomcontrolL779(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(e)(1)(ii)-CommunicatingwithSNF/NForICF/MRrepresentativesandotherhealthcareprovidersparticipatingintheprovisionofcarefortheterminalillnessandrelatedconditionsandotherconditionstoensurequalityofcareforthepatientandfamily.
ProceduresandProbes§418.
112(e)(1)(ii)Ifthereareproblemsidentifiedregardingfailuretocommunicatewithfacilitystaff,interviewthehospicedesignatedIDGmember,andthefacilitycareplancoordinatorforthepatient,inordertodetermine:Thesystemthehospicehasinplacetoensurecontinuityofcommunicationandeasyaccesstoongoinginformation(e.
g.
,documentationinbothrespectiveentitiesclinicalrecords);andHowtheinformationfromeachprovidersteamconferencesgetcommunicatedtotheindividualsparticipatingincaringforthepatient.
Determineiftherehavebeenanyconcernsrelatedtotheneedtochangeoraltertheplanofcare;orifasignificantchangeinconditionoccurredrequiringatransfertoanacutecaresetting,andhowandwhenthefacilitynotifiedthehospiceoftheconcerns.
Intheeventthatthereareconcernsrelatedtothecoordinationandimplementationofthepatientsplanofcareforpaincontrolandsymptommanagement,interviewthefacilitysnurseaideswhoprovidedirectcaretothepatienttodetermine:Iftheyareawareofanycomplaintsofpainfromthepatientorsignsandsymptomsthatcouldindicatethepresenceofpainordiscomfort;Towhomtheyreportthepatientscomplaints,signs,orsymptoms;andIftheyareawareof,andimplement,interventionsforpain/discomfortmanagementforthepatientconsistentwiththepatientsplanofcare,(forexample,allowingaperiodoftimeforapainmedicationtotakeeffectbeforebathingand/ordressing).
Reviewtheplanofcaretodetermineiftheplanwascoordinatedbetweenthehospiceandthefacility.
Determineifsymptommanagement,includingpainmanagementinterventions,areincluded,ifneeded,andaddressedasappropriate:Measurablepainmanagementgoals,reflectingpatientneedsandpreferences;Pertinentnon-pharmacologicaland/orpharmacologicalinterventions;Timeframesandapproachesformonitoringthestatusofthepatientspain,includingtheeffectivenessoftheinterventions;Identificationofclinicallysignificantmedication-relatedadverseconsequencessuchasfalling,constipation,anorexia,ordrowsiness,andaplantominimizethoseadverseconsequences;andWhetherthepainhasbeenreassessedandtheplanofcarerevisedasnecessaryifthecurrentinterventionsarenoteffectiveorthepatienthasexperiencedachangeofconditionorstatus.
Iftheplanofcarereferstoaspecificprotocol,determinewhetherinterventionsareconsistentwiththatprotocol.
Ifapatientsplanofcaredeviatesfromtheprotocol,determinethroughstaffintervieworrecordreviewthereasonforthedeviation.
Interviewafacilitystaffpersonwhoisknowledgeableabouttheneedsandcareofthepatienttodetermine:Howandwhenstaffcommunicatewiththehospicewhen/ifthepatientisexperiencingpain;Ifthepatientreceivespainmedication(includingPRNandadjuvantmedications),how,when,andbywhomtheresultsofmedicationsareevaluated(includingthedose,frequencyofPRNuse,scheduleofroutinemedications,andeffectiveness);Howstaffmonitorfortheemergenceorpresenceofadverseconsequencesofinterventions;Whatisdoneifpainorothersymptomspersistorrecurdespitetreatment,andthebasisfordecisionstomaintainormodifyapproaches;andHowthehospiceandthefacilitycoordinatetheirapproaches,communicateaboutthepatientsneeds,andmonitortheoutcomes(botheffectivenessandadverseconsequences).
L780(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)(2)EnsurethatthehospiceIDGcommunicateswiththeSNF/NForICF/MRmedicaldirector,thepatient'sattendingphysician,andotherphysiciansparticipatingintheprovisionofcaretothepatientasneededtocoordinatethehospicecareofthehospicepatientwiththemedicalcareprovidedbyotherphysicians.
InterpretiveGuidelines§418.
112(e)(2)Bothprovidersmaydocumentphysicianorders.
OrdersaretobedatedandsignedinaccordancewithStatelaws.
Implementationoftheplanofcarechangesresultingfromphysicianordersreceivedbythefacilitymusthavepriorhospiceapproval.
ProceduresandProbes§418.
112(e)(2)Ifconcernswereidentifiedthatchangestotheplanofcare,withoutpriorhospiceapproval,occurredasaresultofphysicianordersreceivedbythefacility,determine:HowtheIDGcommunicateswithphysiciansinvolvedwiththepatient;andIfthereisevidencethattheIDGcommunicateseffectivelywithallphysiciansinvolvedinthepatientscaretoensurethatduplicativeand/orconflictingphysicianordersrelatedtotheterminalillnessandrelatedconditionsarenotissued.
L781(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(e)(3)-ProvidetheSNF/NForICF/MRwiththefollowinginformation:(i)Themostrecenthospiceplanofcarespecifictoeachpatient;(ii)Hospiceelectionformandanyadvancedirectivesspecifictoeachpatient;(iii)Physiciancertificationandrecertificationoftheterminalillnessspecifictoeachpatient;(iv)Namesandcontactinformationforhospicepersonnelinvolvedinhospicecareofeachpatient;(v)Instructionsonhowtoaccessthehospice's24-houron-callsystem;(vi)Hospicemedicationinformationspecifictoeachpatient;and(vii)Hospicephysicianandattendingphysician(ifany)ordersspecifictoeachpatient.
InterpretiveGuidelines§418.
112(e)(3)ThehospiceandfacilitymusthaveaprocessbywhichinformationfromthehospiceIDGplanofcarereviews,updatedassessments,andthefacilityteamandthepatientandfamily(totheextentpossible)willbeexchangedwhendevelopingandupdatingtheplanofcareandevaluatingoutcomesofcaretoassurethatthepatientreceivesthenecessarycareandservices.
Probes§418.
112(e)(3)Interviewfacilitystaffinvolvedinthecareofthepatientontheirknowledgeofhowtocontacthospicestaff24hoursaday.
L782(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
112(f)Standard:OrientationandtrainingofstaffHospicestaffmustassureorientationofSNF/NForICF/MRstafffurnishingcaretohospicepatientsinthehospicephilosophy,includinghospicepoliciesandproceduresregardingmethodsofcomfort,paincontrol,symptommanagement,aswellasprinciplesaboutdeathanddying,individualresponsestodeath,patientrights,appropriateforms,andrecordkeepingrequirements.
InterpretiveGuidelines§418.
112(f)Itisthehospicesresponsibilitytoassesstheneedforstafftrainingandcoordinatethestafftrainingwithrepresentativesofthefacility.
Itisalsothehospicesresponsibilitytodeterminehowfrequentlytrainingneedstobeofferedinordertoensurethatthefacilitystafffurnishingcaretohospicepatientsareorientedtothephilosophyofhospicecare.
Facilitystaffturnoverratesshouldbeaconsiderationindeterminingtrainingfrequency.
ProceduresandProbes§418.
112(f)Ifduringobservationsandinterviewswiththepatient/representativeandstaff,concernsareidentifiedthatstaffarenotfollowingthehospicephilosophy,policiesandproceduresregardingmethodsofcomfort,paincontrol,symptommanagement,aswellasprinciplesaboutdeathanddying,individualresponsestodeath,patientrights,appropriateforms,andrecordkeepingrequirements,interviewhospicestaffonhowtheyhaveprovidededucationtothefacilitystaff.
HowdoesthehospiceassurethatthefacilitystafffurnishingcaretohospicepatientsaretrainedinthehospicephilosophyofcareL783(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114Conditionofparticipation:PersonnelqualificationsL784(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(a):GeneralqualificationrequirementsExceptasspecifiedinparagraph(c)ofthissection,allprofessionalswhofurnishservicesdirectly,underanindividualcontract,orunderarrangementswithahospice,mustbelegallyauthorized(licensed,certifiedorregistered)inaccordancewithapplicableFederal,Stateandlocallaws,andmustactonlywithinthescopeofhisorherStatelicense,orStatecertification,orregistration.
Allpersonnelqualificationsmustbekeptcurrentatalltimes.
L785(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)-Personnelqualificationsforcertaindisciplines.
Thefollowingqualificationsmustbemet:(1)Physician.
PhysiciansmustmeetthequalificationsandconditionsasdefinedinSection1861(r)oftheActandimplementedat§410.
20ofthischapter.
L786(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)(2)Hospiceaide.
HospiceaidesmustmeetthequalificationsrequiredbySection1891(a)(3)oftheActandimplementedat§418.
76.
L787(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)(3)Socialworker.
Apersonwho—(i)(A)HasaMasterofSocialWork(MSW)degreefromaschoolofsocialworkaccreditedbytheCouncilonSocialWorkEducation;or(B)HasabaccalaureatedegreeinsocialworkfromaninstitutionaccreditedbytheCouncilonSocialWorkEducation;orabaccalaureatedegreeinpsychology,sociology,orotherfieldrelatedtosocialworkandissupervisedbyanMSWasdescribedinparagraph(b)(3)(i)(A)ofthissection;and(ii)Hasoneyearofsocialworkexperienceinahealthcaresetting;or(iii)HasabaccalaureatedegreefromaschoolofsocialworkaccreditedbytheCouncilonSocialWorkEducation,isemployedbythehospicebeforeDecember2,2008,andisnotrequiredtobesupervisedbyanMSW.
InterpretiveGuidelines§418.
114(b)(3)Ahospicesocialworkermustatleastmeetoneofthefollowingoptions:1.
HaveanMSWdegreefromaschoolofsocialworkaccreditedbytheCouncilonSocialWorkEducation(CSWE),andoneyearofexperienceinahealthcaresetting.
2.
Haveabaccalaureatedegreeinsocialwork(BSW)fromaschoolofsocialworkaccreditedbytheCSWE,andoneyearofexperienceinahealthcaresettingandbesupervisedbyaMSWfromaschoolofsocialworkaccreditedbytheCSWEandwhohasoneyearofexperienceinahealthcaresetting.
IftheBSWisemployedbythehospicebeforeDecember2,2008,he/sheisexemptedfromtheMSWsupervisionrequirement.
3.
Haveabaccalaureatedegreeinpsychology,sociology,orotherfieldrelatedtosocialwork,andatleastoneyearofsocialworkexperienceinahealthcaresettingandbesupervisedbyaMSWfromaschoolofsocialworkaccreditedbytheCSWEandwhohasoneyearofexperienceinahealthcaresetting.
ThehospicemustalsodefertoStatelawregardingsocialworkrequirements.
IfStaterequirementsaremorestringent,thehospicemustcomplywiththeStaterequirements.
Forexample,iftheStaterequiresasocialworkertohaveaBSWoranMSW,thehospicemaynotemployapersonwithabaccalaureatedegreeinpsychology,sociology,orotherfieldrelatedtosocialworktoworkasahospicesocialworker.
EachhospicemustemployorcontractwithatleastoneMSWtoserveinthesupervisorroleasanactiveadvisor,consultingwiththeBSWonassessingtheneedsofpatientsandfamilies,developingandupdatingthesocialworkportionoftheplanofcare,anddeliveringcaretopatientsandfamilies.
Thissupervisionmayoccurinperson,overthetelephone,throughelectroniccommunication,oranycombinationthereof.
Thehospicemustallowtimeforthissupervisiontohappenonaregularbasisandprovidedocumentationastothenatureandscopeofsupervision.
Thehospicemustalsoensurethatnon-socialworktrainedbachelorspreparedemployeesfillingtheroleofsocialworkeraresupervisedbyaMSWwhograduatedfromaschoolofsocialworkaccreditedbytheCSWE,andwhohasatleastoneyearofexperienceinahealthcaresetting.
SocialworkerswithabaccalaureatedegreefromaschoolofsocialworkaccreditedbytheCSWEandwhoareemployedbythehospicebeforeDecember2,2008,areexemptedfromtheMSWsupervisionrequirement.
IfahospicehiresanewsocialworkerwithabaccalaureatedegreeandoneyearofexperienceinahealthcaresettingafterDecember2,2008,thenthebaccalaureatesocialworkermustbesupervisedbyanMSWwhohasoneyearofexperienceinahealthcaresetting.
L788(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)(4)-Speechlanguagepathologist.
Apersonwhomeetseitherofthefollowingrequirements:(i)TheeducationandexperiencerequirementsforaCertificateofClinicalCompetenceinspeech-languagepathologygrantedbytheAmericanSpeech-Language-HearingAssociation.
(ii)Theeducationalrequirementsforcertificationandisintheprocessofaccumulatingthesupervisedexperiencerequiredforcertification.
L789(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)(5)-Occupationaltherapist.
Apersonwho—(i)(A)Islicensedorotherwiseregulated,ifapplicable,asanoccupationaltherapistbytheStateinwhichpracticing,unlesslicensuredoesnotapply;(B)GraduatedaftersuccessfulcompletionofanoccupationaltherapisteducationprogramaccreditedbytheAccreditationCouncilforOccupationalTherapyEducation(ACOTE)oftheAmericanOccupationalTherapyAssociation,Inc.
(AOTA),orsuccessororganizationsofACOTE;and(C)Iseligibletotake,orhassuccessfullycompletedtheentry-levelcertificationexaminationforoccupationaltherapistsdevelopedandadministeredbytheNationalBoardforCertificationinOccupationalTherapy,Inc.
(NBCOT).
(ii)OnorbeforeDecember31,2009—(A)Islicensedorotherwiseregulated,ifapplicable,asanoccupationaltherapistbytheStateinwhichpracticing;or(B)Whenlicensureorotherregulationdoesnotapply—(1)GraduatedaftersuccessfulcompletionofanoccupationaltherapisteducationprogramaccreditedbytheaccreditationCouncilforOccupationaltherapyEducation(ACOTE)oftheAmericanOccupationalTherapyAssociation,Inc.
(AOTA)orsuccessororganizationsofACOTE;and(2)Iseligibletotake,orhassuccessfullycompletedtheentry-levelcertificationexaminationforoccupationaltherapistsdevelopedandadministeredbytheNationalBoardforCertificationinOccupationalTherapy,Inc.
,(NBCOT).
(iii)OnorbeforeJanuary1,2008—(A)GraduatedaftersuccessfulcompletionofanoccupationaltherapyprogramaccreditedjointlybythecommitteeonAlliedHealthEducationandAccreditationoftheAmericanMedicalAssociationandtheAmericanOccupationalTherapyAssociation;or(B)IseligiblefortheNationalRegistrationExaminationoftheAmericanOccupationalTherapyAssociationortheNationalBoardforCertificationinOccupationalTherapy.
(iv)OnorbeforeDecember31,1977—(A)Had2yearsofappropriateexperienceasanoccupationaltherapist;and(B)Hadachievedasatisfactorygradeonanoccupationaltherapistproficiencyexaminationconducted,approved,orsponsoredbytheU.
S.
PublicHealthService.
(v)IfeducatedoutsidetheUnitedStates—(A)Mustmeetbothofthefollowing:(1)GraduatedaftersuccessfulcompletionofanoccupationaltherapisteducationprogramaccreditedassubstantiallyequivalenttooccupationaltherapistassistantentryleveleducationintheUnitedStatesbyoneofthefollowing:(i)TheAccreditationCouncilforOccupationalTherapyEducation(ACOTE).
(ii)SuccessororganizationsofACOTE.
(iii)TheWorldFederationofOccupationalTherapists.
(iv)AcredentialingbodyapprovedbytheAmericanOccupationalTherapyAssociation.
(v)SuccessfullycompletedtheentrylevelcertificationexaminationforoccupationaltherapistsdevelopedandadministeredbytheNationalBoardforCertificationinOccupationalTherapy,Inc.
(NBCOT).
(2)OnorbeforeDecember31,2009,islicensedorotherwiseregulated,ifapplicable,asanoccupationaltherapistbytheStateinwhichpracticing.
L790(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)(6)-Occupationaltherapyassistant.
Apersonwho—(i)Meetsallofthefollowing:(A)Islicensedorotherwiseregulated,ifapplicable,asanoccupationaltherapyassistantbytheStateinwhichpracticing,unlesslicensuredoesapply.
(B)GraduatedaftersuccessfulcompletionofanoccupationaltherapyassistanteducationprogramaccreditedbytheAccreditationCouncilforOccupationalTherapyEducation,(ACOTE)oftheAmericanOccupationalTherapyAssociation,Inc.
(AOTA)oritssuccessororganizations.
(C)Iseligibletotakeorsuccessfullycompletedtheentry-levelcertificationexaminationforoccupationaltherapyassistantsdevelopedandadministeredbytheNationalBoardforCertificationinOccupationalTherapy,Inc.
(NBCOT).
(ii)OnorbeforeDecember31,2009—(A)Islicensedorotherwiseregulatedasanoccupationaltherapyassistant,ifapplicable,bytheStateinwhichpracticing;oranyqualificationsdefinedbytheStateinwhichpracticing,unlesslicensuredoesnotapply;or(B)Mustmeetbothofthefollowing:(1)CompletedcertificationrequirementstopracticeasanoccupationaltherapyassistantestablishedbyacredentialingorganizationapprovedbytheAmericanOccupationalTherapyAssociation.
(2)AfterJanuary1,2010,meetstherequirementsinparagraph(b)(6)(i)ofthissection.
(iii)AfterDecember31,1977andonorbeforeDecember31,2007—(A)CompletedcertificationrequirementstopracticeasanoccupationaltherapyassistantestablishedbyacredentialingorganizationapprovedbytheAmericanOccupationalTherapyAssociation;or(B)CompletedtherequirementstopracticeasanoccupationaltherapyassistantapplicableintheStateinwhichpracticing.
(iv)OnorbeforeDecember31,1977—(A)Had2yearsofappropriateexperienceasanoccupationaltherapyassistant;and(B)Hadachievedasatisfactorygradeonanoccupationaltherapyassistantproficiencyexaminationconducted,approved,orsponsoredbytheU.
S.
PublicHealthService.
(v)IfeducatedoutsidetheUnitedStates,onorafterJanuary1,2008—(A)GraduatedaftersuccessfulcompletionofanoccupationaltherapyassistanteducationprogramthatisaccreditedassubstantiallyequivalenttooccupationaltherapistassistantentryleveleducationintheUnitedStatesby—(1)TheAccreditationCouncilforOccupationalTherapyEducation(ACOTE).
(2)Itssuccessororganizations.
(3)TheWorldFederationofOccupationalTherapists.
(4)ByacredentialingbodyapprovedbytheAmericanOccupationalTherapyAssociation;and(5)SuccessfullycompletedtheentrylevelcertificationexaminationforoccupationaltherapyassistantsdevelopedandadministeredbytheNationalBoardforCertificationinOccupationalTherapy,Inc.
(NBCOT).
L791(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)(7)-Physicaltherapist.
Apersonwhoislicensed,ifapplicable,bytheStateinwhichpracticing,unlesslicensuredoesnotapplyandmeetsoneofthefollowingrequirements:(i)Graduatedaftersuccessfulcompletionofaphysicaltherapisteducationprogramapprovedbyoneofthefollowing:(A)TheCommissiononAccreditationinPhysicalTherapyEducation(CAPTE).
(B)SuccessororganizationsofCAPTE.
(C)AneducationprogramoutsidetheUnitedStatesdeterminedtobesubstantiallyequivalenttophysicaltherapistentryleveleducationintheUnitedStatesbyacredentialsevaluationorganizationapprovedbytheAmericanPhysicalTherapyAssociationoranorganizationidentifiedin8CFR212.
15(e)asitrelatestophysicaltherapists.
(D)PassedanexaminationforphysicaltherapistsapprovedbytheStateinwhichphysicaltherapyservicesareprovided.
(ii)OnorbeforeDecember31,2009—(A)GraduatedaftersuccessfulcompletionofaphysicaltherapycurriculumapprovedbytheCommissiononAccreditationinPhysicalTherapyEducation(CAPTE);or(B)Meetsbothofthefollowing:(1)GraduatedaftersuccessfulcompletionofaneducationprogramdeterminedtobesubstantiallyequivalenttophysicaltherapistentryleveleducationintheUnitedStatesbyacredentialsevaluationorganizationapprovedbytheAmericanPhysicalTherapyAssociationoridentifiedin8CFR212.
15(e)asitrelatestophysicaltherapists.
(2)PassedanexaminationforphysicaltherapistsapprovedbytheStateinwhichphysicaltherapyservicesareprovided.
(iii)BeforeJanuary1,2008—(A)Graduatedfromaphysicaltherapycurriculumapprovedbyoneofthefollowing:(1)TheAmericanPhysicalTherapyAssociation.
(2)TheCommitteeonAlliedHealthEducationandAccreditationoftheAmericanMedicalAssociation.
(3)TheCouncilonMedicalEducationoftheAmericanMedicalAssociationandtheAmericanPhysicalTherapyAssociation.
(iv)OnorbeforeDecember31,1977waslicensedorqualifiedasaphysicaltherapistandmeetsbothofthefollowing:(A)Has2yearsofappropriateexperienceasaphysicaltherapist.
(B)Hasachievedasatisfactorygradeonaproficiencyexaminationconducted,approved,orsponsoredbytheU.
S.
PublicHealthService.
(v)BeforeJanuary1,1966—(A)WasadmittedtomembershipbytheAmericanPhysicalTherapyAssociation;(B)WasadmittedtoregistrationbytheAmericanRegistryofPhysicalTherapists;and(C)Graduatedfromaphysicaltherapycurriculumina4-yearcollegeoruniversityapprovedbyaStatedepartmentofeducation.
(vi)BeforeJanuary1,1966waslicensedorregistered,andbeforeJanuary1,1970,had15yearsoffulltimeexperienceinthetreatmentofillnessorinjurythroughthepracticeofphysicaltherapyinwhichserviceswererenderedundertheorderanddirectionofattendingandreferringdoctorsofmedicineorosteopathy.
(vii)IftrainedoutsidetheUnitedStatesbeforeJanuary1,2008,meetsthefollowingrequirements:(A)Wasgraduatedsince1928fromaphysicaltherapycurriculumapprovedinthecountryinwhichthecurriculumwaslocatedandinwhichthereisamemberorganizationoftheWorldConfederationforPhysicalTherapy.
(B)MeetstherequirementsformembershipinamemberorganizationoftheWorldConfederationforPhysicalTherapy.
L792(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(b)(8)-Physicaltherapistassistant.
Apersonwhoislicensed,registeredorcertifiedasaphysicaltherapistassistant,ifapplicable,bytheStateinwhichpracticing,unlesslicensuredoesnotapplyandmeetsoneofthefollowingrequirements:(i)GraduatedfromaphysicaltherapistassistantcurriculumapprovedbytheCommissiononAccreditationinPhysicalTherapyEducationoftheAmericanPhysicalTherapyAssociation;orifeducatedoutsidetheUnitedStatesortrainedintheUnitedStatesmilitary,graduatedfromaneducationprogramdeterminedtobesubstantiallyequivalenttophysicaltherapistassistantentryleveleducationintheUnitedStatesbyacredentialsevaluationorganizationapprovedbytheAmericanPhysicalTherapyAssociationoridentifiedat8CFR212.
15(e);and(ii)Passedanationalexaminationforphysicaltherapistassistants.
(A)OnorbeforeDecember31,2009,meetsoneofthefollowing:(1)Islicensed,orotherwiseregulatedintheStateinwhichpracticing.
(2)InStateswherelicensureorotherregulationsdonotapply,graduatedbeforeDecember31,2009,froma2-yearcollege-levelprogramapprovedbytheAmericanPhysicalTherapyAssociationandafterJanuary1,2010,meetstherequirementsofparagraph(b)(8)ofthissection.
(3)BeforeJanuary1,2008,wherelicensureorotherregulationdoesnotapply,graduatedfroma2-yearcollegelevelprogramapprovedbytheAmericanPhysicalTherapyAssociation.
(4)OnorbeforeDecember31,1977,waslicensedorqualifiedasaphysicaltherapistassistantandhasachievedasatisfactorygradeonaproficiencyexaminationconducted,approved,orsponsoredbytheU.
S.
PublicHealthService.
L793(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(c)-PersonnelqualificationswhennoStatelicensing,certificationorregistrationrequirementsexist.
IfnoStatelicensinglaws,certificationorregistrationrequirementsexistfortheprofession,thefollowingrequirementsmustbemet:(1)Registerednurse.
Agraduateofaschoolofprofessionalnursing.
L794(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(c)(2)-Licensedpracticalnurse.
Apersonwhohascompletedapracticalnursingprogram.
L795(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(d)Standard:Criminalbackgroundchecks(1)Thehospicemustobtainacriminalbackgroundcheckonallhospiceemployeeswhohavedirectpatientcontactoraccesstopatientrecords.
Hospicecontractsmustrequirethatallcontractedentitiesobtaincriminalbackgroundchecksoncontractedemployeeswhohavedirectpatientcontactoraccesstopatientrecords.
L796(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
114(d)(2)-CriminalbackgroundchecksmustbeobtainedinaccordancewithStaterequirements.
IntheabsenceofStaterequirements,criminalbackgroundchecksmustbeobtainedwithinthreemonthsofthedateofemploymentforallstatesthattheindividualhaslivedorworkedinthepast3years.
L797(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
116Conditionofparticipation:CompliancewithFederal,State,andlocallawsandregulationsrelatedtothehealthandsafetyofpatients.
L798(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
116-ThehospiceanditsstaffmustoperateandfurnishservicesincompliancewithallapplicableFederal,State,andlocallawsandregulationsrelatedtothehealthandsafetyofpatients.
IfStateorlocallawprovidesforlicensingofhospices,thehospicemustbelicensed.
L799(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
116(a)Standard:Multiplelocations.
Everyhospicemustcomplywiththerequirementsof§420.
206ofthischapterregardingdisclosureofownershipandcontrolinformation.
AllhospicemultiplelocationsmustbeapprovedbyMedicareandlicensedinaccordancewithStatelicensurelaws,ifapplicable,beforeprovidingMedicarereimbursedservices.
L800(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
116(b)Standard:Laboratoryservices.
(1)Ifthehospiceengagesinlaboratorytestingotherthanassistingapatientinself-administeringatestwithanappliancethathasbeenapprovedforthatpurposebytheFDA,thehospicemustbeincompliancewithallapplicablerequirementsofpart493ofthischapter.
InterpretiveGuidelines§418.
116(b)(1)Determineifthehospiceisprovidinglaboratorytestingassetforthat42CFRPart493.
Ifthehospiceisperformingtesting,requesttoseetheClinicalLaboratoryImprovementAmendments(CLIA)certificatefortheleveloftestingbeingperformed,i.
e.
,acertificateofwaiver,certificateforprovider-performedmicroscopyprocedures,certificateofaccreditation,certificateofregistration,orcertificateofcompliance(issueduponthedeterminationofcomplianceafteranon-sitesurvey).
Hospicesholdingacertificateofwaiverarelimitedtoperformingonlythosetestsdeterminedtobeinthewaivedcategory.
Someteststhatahospicemayperformthatfallintothewaivedcategoryinclude:Dipstick/tabletreagenturinalysis;BloodglucosebyglucosemonitoringdevicesclearedbytheFoodandDrugAdministration(FDA)specificallyforhomeuse;Someprothrombintimetests;andSomeglycosolatedhemoglobintests.
Foracompletelistingofwaivedtests,refertoCMSwebsiteathttp://www.
cms.
hhs.
gov/CLIA/10_Categorization_of_Tests.
asp#TopOfPageHospicesholdingacertificateforprovider-performedmicroscopyproceduresarelimitedtoperformingonlythosetestsdeterminedtobeintheprovider-performedmicroscopyprocedurecategoryorincombinationwithwaivedtests.
Thetestsintheprovider-performedmicroscopyprocedurescategory(e.
g.
,wetmounts,urinesedimentexaminations,andnasalsmearsforgranulocytes)arenottypicalofthoseperformedinahospice.
However,iftheyareconductedbyhospicestaffunderacertificateforprovider-performedmicroscopyprocedures,theymustbeperformedbyapractitionerasspecifiedat§493.
19(i.
e.
,aphysician,nursemidwife,nursepractitioner,physicianassistant,ordentist).
Ifnotperformedbythesepersonnel,thehospicewouldrequirearegistrationcertificate(whichallowstheperformanceofsuchtestinguntiladeterminationofcomplianceismade),certificateofaccreditation,orcertificateofcompliance.
Foracompletelistingofprovider-performedmicroscopyprocedures,refertoCMSwebsiteathttp://www.
cms.
hhs.
gov/CLIA/10_Categorization_of_Tests.
asp#TopOfPageAregistrationcertificate,acertificateofaccreditation,oracertificateofcomplianceisrequiredifthehospiceperformsanyothertestingprocedures,(i.
e.
,moderateorhighcomplexitytesting).
Whilesomeprothrombintestingisinthewaivedcategory,asmentionedabove,otherprothrombintestingisconsideredmoderatecomplexitytestingdependingontheskilllevelrequiredtooperatetheinstrument.
Foracompletelistingofmoderateandhighcomplexitytests,refertoCMSwebsiteathttp://www.
cms.
hhs.
gov/CLIA/10_Categorization_of_Tests.
asp#TopOfPageAssistingindividualsinadministeringtheirowntests,suchasfingerstickbloodglucoseorprothrombintesting,isnotconsideredtestingsubjecttotheCLIAregulations.
However,ifthehospicestaffisactuallyresponsibleformeasuringthebloodglucoselevelorprothrombintimesofpatientswithanFDA-approvedbloodglucoseorprothrombintimemonitor,andnoothertestsarebeingperformed,requesttoseethefacilityscertificateofwaiver,sinceglucosetestingwithabloodglucosemeter(approvedbytheFDAspecificallyforhomeuse)andsomeprothrombintimetestsarewaivedtestsundertheprovisionsat42CFR493.
15.
IfthehospicedoesnotpossesstheappropriateCLIAcertificate,informthehospicethatitisinviolationofCLIAlawandthatitmustapplyimmediatelytotheStateAgencyfortheappropriatecertificate.
Thehospiceisoutofcompliancewith42CFR418.
116(b).
Also,referthishospicesnoncompliancetothedepartmentwithintheStateAgencyresponsibleforCLIAsurveys.
L801(Rev.
65,Issued:10-01-10,Effective:10-01-10,Implementation:10-01-10)§418.
116(b)(2)-Ifthehospicechoosestoreferspecimensforlaboratorytestingtoareferencelaboratory,thereferencelaboratorymustbecertifiedintheappropriatespecialtiesandsubspecialtiesofservicesinaccordancewiththeapplicablerequirementsofPart493ofthischapter.
InterpretiveGuidelines§418.
116(b)(2)ThehospiceisrequiredtocomplywithapplicableStatelawandsecureaCLIAcertificateofwaiverforanywaivedtestingperformedbystaff.
LabspecimensobtainedinthepatientshomemustbetakentolaboratoriesthatmeetCLIAandstatelawrequirements.
ThehospiceshouldhaveacopyofthereferencelaboratorysCLIAcertificateinitsadministrativerecords.