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Pharmacy F-Tag and Survey Updates - What You …4/4/18 1 Guardian Consulting Services, Inc....

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4/4/18 1 Guardian Consulting Services, Inc. Consultant Pharmacists for Healthcare Facilities Pharmacy F-Tag and Survey Updates - What You Need To Know! Presented by: Dr. William C. Hallett, Pharm.D., MBA, BCGP, C-MTM President/CEO Guardian Consulting Services, Inc. [email protected] (855) 625-6235 Guardian Consulting Services, Inc. Consultant Pharmacists for Healthcare Facilities Goals for the Day 1. Review the Pharmacy related sections of the recently released updates to the State Operations Manual 2. Provide an overview of what we are seeing and experiencing in recent surveys 3. Outline practical compliance strategies Guardian Consulting Services, Inc. Consultant Pharmacists for Healthcare Facilities State Operations Manual (SOM) Appendix PP Better known as the F-Tags AKA the “Guidance to Surveyors” Full re-write released June 30 th , 2017; went into effect November 28, 2017 Written to accompany the November 2016 Final Rule, AKA the “Mega Rule” Regulations 696 Total Pages of Regulations and Guidance This re-write represents a total re-numbering (and expansion!) of the F-Tags as we had known them!
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4/4/18

1

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

PharmacyF-TagandSurveyUpdates-

WhatYouNeedToKnow!

Presentedby:

Dr.WilliamC.Hallett,Pharm.D.,MBA,BCGP,C-MTMPresident/CEO–GuardianConsultingServices,Inc.

[email protected](855)625-6235

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

GoalsfortheDay

1.  ReviewthePharmacyrelatedsectionsoftherecentlyreleasedupdatestotheStateOperationsManual

2.  Provideanoverviewofwhatweareseeingandexperiencinginrecentsurveys

3.  Outlinepracticalcompliancestrategies

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

StateOperationsManual(SOM)AppendixPP

BetterknownastheF-Tags•  AKAthe“GuidancetoSurveyors”•  Fullre-writereleasedJune30th,2017;wentintoeffectNovember28,2017

•  WrittentoaccompanytheNovember2016FinalRule,AKAthe“MegaRule”Regulations

•  696TotalPagesofRegulationsandGuidance•  Thisre-writerepresentsatotalre-numbering(andexpansion!)oftheF-Tagsaswehadknownthem!

4/4/18

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

StateOperationsManualAppendixPPUpdate

PharmacyRelatedFtagsCrosswalk:F755:PharmacyServices(FormerlyF425)F756:DrugRegimenReview(FormerlyF428)F757/F758:UnnecessaryMedications/PsychotropicMedications(FormerlyF329plusNEW)F759/F760:MedicationErrors(FormerlyF332/F333)F761:LabelingandStorageofMedications(FormerlyF431)F881:InfectionPreventionandControlProgram;AntibioticStewardship(NEW)F883:InfluenzaandPneumococcalImmunizations(FormerlyF334)

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

StateOperationsManualAppendixPPUpdate

F757UnnecessaryMedications

F758:PsychotropicMedications

Forallthechanges,it’s(mostly)stillallabout(preventingmis)useinDEMENTIA.

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F757:UnnecessaryMedicationsandF758:PsychotropicMedications–28Pages

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedications

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedications,continued…

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedicationsKeyrequirements,restated:SpecificConditions;GDR;

TimeLimitsonPRN’s

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedications

Definitionofapsychotropicdrug:

GradualDoseReductionRequirements:

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedicationsDeterminingwhenGDRis“ClinicallyContraindicated”:

EnduringConditions:Psychotropicmedicationsmaybeusedtotreatanenduring

(i.e.,nonacute;chronicorprolonged)condition.

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedicationsDocumenting“ClinicallyContraindicated”:

Scenario1:ChronicEnduringConditionsuchasSchizophrenia,BipolarDisorder,

MajorDepression:

“ContinueSeroquelforchronicenduringconditionofBipolardisorder.Gradual

dosereductionclinicallycontraindicated,residenthighlylikelytodeteriorateand

becomeadangertoselfandothers.”

Scenario2:OtherchronicconditionsOTHERTHANDEMENTIAthatresultin

psychosis

“ContinueRisperdalforchronicpsychosisrelatedtoTraumaticBrainInjury.

Gradualdosereductionclinicallycontraindicated,residenthighlylikelyto

deteriorateandbecomeadangertoselfandothers.”

**InALLOTHERSCENARIOS:GradualDoseReduction(GDR)inanefforttoD/C

MUSTbeattemptedandfailin2consecutivequartersbeforeGDRcanbe

considered“ClinicallyContraindicated”.

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedicationsRecentSurveyActivityandRecommendations:1.   REMEMBER:ThefocusremainsonDEMENTIA

a)  Makesureyouareidentifyingresidentsonpsychotropicsthathavethe

word“Dememtia”inthediagnosis.TheseWILLbetheeasytargets.

2.   Bepreparedtodefendappropriate,longtermusewithoutGDRuseinMajorDepression

3.   Bewareof“ClassShifting”a)  Anxiolytics(ex:Ativan,Xanax),Anticonvuslantsforbehaviors,and

Antidepressants(forusesotherthandepression)arebecomingjustasbigafocus!

4.   Don’tfallintothetrapof”DiagnosisDrift”a)  Don’twriteSchizophrenia(orBipolarDisorder)unlessthediagnosisis

REAL.b)  Key:UnderstandingthedifferencebetweentheSurveyProcessandthe

CMSFiveStarQualityMeasuresonAntipsychotics

5.   RunandanalyzereportsfromyourEMR,or……

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedications

PRNPsychotropics(OtherthanAntipsychotics):•  14days,maybeextendedbeyond14daysprovidedrationale

isdocumentedbythepractitionerandthetimedurationisspecified.–  ThisINCLUDESsleepinductionmedssuchasZolpidem(Ambien).

PRNAntipsychotics:•  Max14days,noexceptions.Ifthepractitionerwishestowrite

anewPRNorder,mayonlydosoafter“evaluatingtheresident”.–  HospiceisNOTexcludedfromthisguidance.

GuidanceonPRNAntipsychoticsandPsychotropics

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedicationsDefinitionof“Evaluating”=“directlyexaminingtheresident”

ComplianceStrategy:ContinuetoavoidPRNantipsychoticsandpsychotropicstotheabsolutegreatestextentpossible.

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F758:PsychotropicMedications

ExamplesofKeyElementsofNoncompliance

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

StateOperationsManualF755:PharmacyServices–14pages

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F755:PharmacyServicesConsultantPharmacist’sresponsibilityfor

oversightofControlledDrugrecordkeeping:

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F755:PharmacyServices

BorrowingofMedicationsasasourceofmedicationerrors:

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F755:PharmacyServicesRecentSurveyExperienceandComplianceStrategies:1.   MedicationRoomInspectionisstill(often)FIRST

a)  Cleanlinesscounts!b)  Focus:Expiredmeds;Refrigerators;Ekits;NarcBoxes

2.   Expandedchecksoncontrolledsubstanceaccountabilitya)  Checksofnarcboxlocks;refrigeratednarcsb)  Presenceofexpired/discontinuednarcsonunitc)  Examiningdescendingcountssheetsformissingsignatures

3.   SeparateBNEInspectionsa)  Oftenoccurondayofschedulednarcoticinspectionsb)  Includeschecksofhowdiscontinuedcontrolledsubstancesare

storedaftercollectionandawaitingdestructionc)  Makesureyourpoliciesandproceduresareinorder!

1)  ApplicableregulationsappearatTitle10NYCRR80.49and80.50

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F756:DrugRegimenReview–10pages

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F756:DrugRegimenReview

TimeFramesforResponsetoDRR’s;Handlingof“Urgent”findings

:

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F756:DrugRegimenReviewDocumentationofDrugRegimenReview

Regulation:

Guidance:

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F756:DrugRegimenReviewResponsetoDrugRegimenReview:

Compliancemethods:•  WriteupDRRinEMR,physicianrespondsinEMR

Problem:EMR’slackabilitytotrack“open”DRR’s!

•  WriteupDRRonpaper,scantoEMRorfileonpaperchartAFTERphysicianresponds(KeepcopiesinbinderinNursingOffice!)

•  WriteupDRRonpaper,physicianresponds,maintaininbinderuntilaftersurvey,THENscantoEMRorfilewithpaperchart.

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F756:DrugRegimenReview

RecentSurveyActivityandRecommendations:

1.   Sofar,littletonoactionon“prescriberresponseonchart”

2.   HaveyourMedicationRegimenReviewpolicyREADY.1.   Remember:PolicymustspecifyTIMEFRAMES.

3.   Commonpractice:Surveyorsrequest“6Residents/Last6Months”a)  SurveyorrequestsjustONEresident?Usuallyindicatesthereis

anissue/concern.

4.   UsinganEMR?MakesureyouremindwheretheDNS/designeewhereconsultantPharmacistsigns

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F759/F760:MedicationErrors–12Pages

Overall– 12pagesofexcellentguidancethatcanbeusefulasa“MedPassTeaching”guide!

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F759/F760:MedicationErrors

“SignificantMedicationError”meansonethatcausestheresidentdiscomfortorjeopardizeshisorherhealthandsafety.

Definitions:

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F759/F760:MedicationErrors

CalculatingMedErrorRates:

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F759/F760:MedicationErrors

:

GuidanceonadministeringcrushedmedsbyORALand

viatheGTroutesindividually:

Somegoodnews…..

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F759/F760:MedicationErrors

:

FromaNovember14th,2017correspondencetotheAmericanSocietyofConsultantPharmacistsMemorandum– CMSwillbe

reversingit’sguidanceonadministeringcrushedORAL

medicationsseparately:

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GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

F759/F760:MedicationErrors

Additionalareascoveredinthisguidance:

•  Givingadequatefluidwithmedications– Metamucil,Alendronate,Potassium

•  Medicationsthat*must*betakenwithfoodorantacids

•  Potentialforadverseconsequencesfromherbalanddietarysupplements

•  Propereyedropadministration•  MeteredDoseInhalerprocedures

GuardianConsultingServices,Inc.ConsultantPharmacistsforHealthcareFacilities

PharmacyF-TagandSurveyUpdates-

WhatYouNeedToKnow!

Presentedby:

Dr.WilliamC.Hallett,Pharm.D.,MBA,BCGP,C-MTMPresident/CEO–GuardianConsultingServices,Inc.

[email protected](855)625-6235


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