Presentation on theme: "The Joint Commission Laboratory Program- What’s New"— Presentation transcript:
1 The Joint Commission Laboratory Program- What’s New Jennifer RhamyExecutive Director
2 What’s New at The Joint Commission Me- and excited to be working with all of youLab STAT News monthly sRecent customer survey to hear voice of the customerDedicated account executives for laboratoryIncreased alliance of the hospital and lab programs
3 Ongoing Lab Focus quarterly newsletter Lab Advantage program Discounted program for bundled proficiency testing, ASCP educational programs, and The Joint Commission accreditation.See for more information
4 Coming SoonCrosswalk of The Joint Commission and CLIA standards available as part of e-ditionDevelopment of the next revision of Laboratory Accreditation Standards and working collaboratively with ASCP to identify volunteers2010 Laboratory Accreditation OverviewLeading Practices DatabaseeApplication for lab in 2011Deeming process in late 2010
5 EXAMPLE: Crosswalk Display for Home Health CMS Requirements—may include multiple CMS areasJoint Commission EP
7 Come meet with us! Will have a booth at AACC, CLMA, and ASCP this year Speaking at SEABBAnother free audio conference next fallOther audio conferences and publications listed on the web site
8 Summary We want to hear from you Initiatives are being driven by communications out to the accredited facilities or getting feedbackConcentrating on standards and accreditation process improvements in 2010
9 Tips For A Successful Survey use these colorsTips For A Successful SurveyKathie SteffensField Director
10 Documents and Information Test Menu and Instruments UsedTests that you perform in your laboratoryTotal Test Volume for each CLIAABG =1 procedurepH, pCO2, pO2 = 3 testsCLIA Certificate(s)For all laboratory services provided on-site.
11 Documents and Information Environmental and Safety InspectionsSafety Committee ReportsHazardous Waste Disposal ManifestsInfection Control Policy and ProcessesPerformance ImprovementData gatheredData analysis and conclusionsImprovements ImplementedOn-going monitoring
12 Documents and Information Proficiency Testing for last 6 eventsCopies (hard copy or electronic) of original test performanceProcedure for handling and assessing PTAttestation signed by testing personnelReview of PT results from vendorInvestigation and corrective action of all unacceptable results.
13 Documents and Information Policy and ProceduresDo not need to move to a central locationQuality Control DataLast 24 months accessibleCalibration and Calibration VerificationPerformance over last 24 months accessible
14 Documents and Information Maintenance RecordsLast 24 months accessiblePersonnel FilesHave someone available who knows HR file system.Validation of educational requirementsState licenses as applicableCompetency Assessment RecordsCurrent and last annual assessment
15 Tracer ActivityPatient tracers cover all specialties and subspecialties across the period from the last full surveyMay be less than 24 months.Labs converting from another accreditorare reviewed for prior four months activity, except for PT which is for 24 months.
16 Tips for Survey Know how to access information. If on paper, how to retrieve ifinformation is in storageIf electronic, what program(s) willyou need to access for historic dataIf using EMR, who will be needed to access patient information
17 Tips for Survey Encourage staff to openly participate. If staff doesn’t understand what the surveyor wants, ask the surveyor to explain in more detail.If staff doesn’t know the answer to a question, it’s okay to say they don’t.Tell the surveyor how your lab complies with standard within your lab.Every lab doesn’t comply the same way.Have open discussion about standards.
18 Tips for Survey Point-of-Care Sites Off-site locations Inform all staff that they will be asked to participate in survey.Off-site locationsInform all staff of same information that will be required for their survey activity.Staff availabilityLet the surveyor know who might be available only on certain days.
19 2010 Standards - Tips & Topics Megan E. Sawchuk, MT(ASCP)Associate Director, Standards Interpretation Group
20 Standards Applicability Standards are applicable based on:Definition of a lab test as regulated by CLIAExceptionsMultiple test complexity levelsMultiple laboratory accreditorsMultiple health care accreditation programs, e.g. hospital, ambulatory, lab
21 Which organization standards apply to laboratory services? Accreditation programs include:HospitalCritical Access HospitalAmbulatoryOffice Based SurgeryLong Term CareHome CareBehavioral HealthManuals include complementary “core” standardsSimilar across all The Joint Commission accreditation programsStandards often met with organizational policies
22 Core standards chapters Accreditation Participation Requirements (APR)Environment of Care (EC)Emergency Management (EM)Human Resources (HR)Infection Control (IC)Information Management (IM)Leadership (LD)National Patient Safety Goals (NPSG)Performance Improvement (PI)Transplant Safety (TS)Waived Testing (WT)
23 Organizational standards applicable to laboratory services Waived testing: APRs, NPSGs, LD , WT chaptersNon-waived testing: Other standards could be reviewed incidental to hospital tracer, e.g. safety, infection control, general policies (specimen collection & transport)No technical testing requirements would be surveyedOther related clinical and hospital requirements, e.g. transfusion medicineMany related to Medicare’s Conditions of Participation (CoPs), e.g. 42 CFR Hospital Laboratory Services
24 Tip: Hospital standards related to blood administration EC Emergency power for blood storage systemsHR Special training provided for transfusion administrationMS Medical staff involved in PI activities for blood & blood usePC Transfusions administered per law & medical staff policyPC HIV/HCV Notification (Look back) policiesPC Transfusion administration equipment is available for operative and other high-risk proceduresPI Organization collects data on blood and blood use, and all reported and confirmed transfusion reactionsRI Informed consent processNPSG Two identifiers used to ID patient for transfusionNPSG Two persons verify patient ID and product for transfusionUP Standardized pre-op verification list, including blood product availability (and other laboratory reports)
25 Tip: Hospital standards related to laboratory services HR Testing personnel meet the qualifications defined in the CLIA regulationsIC Laboratory resources are provided to support infection prevention and control programIC Cleaning and disinfection of bedside point-of-care instruments, e.g. glucose metersLD All laboratory services have CLIA certificates and licenses required by regulationLD Pathology and clinical laboratory services are provided (essential service) to meet patient needsLD Performance management of contracted laboratory services; maintaining evidence of CLIA compliance for reference and contract laboratory servicesMM Necessary laboratory results are available to those managing a patient’s medications
26 Tip: Hospital standards related to laboratory services MS Medical staff involved in PI activities for autopsiesMS – MS Credentialing and privileging of licensed independent practitioners (LIPs) providing interpretive reports, e.g. pathologists performing histopathologyMS – MS Ongoing & Focused Practitioner Performance Evaluation (OPPE & FPPE), applies to the above LIPsNPSG Reporting of critical results (clinical reporting intervals, such as nurse to physician, not those of the main laboratory)NPSG Baseline and ongoing testing for anticoagulation therapy provided per written protocol/policy approved by medical staffPC Surgical tissue specimen policies, e.g. gross only, exceptions to submission to pathology, specimen handlingTS – TS Tissue storage and issuance (if lab oversees)WT – WT Waived Testing
27 The Joint Commission Laboratory Accreditation Program Laboratory application submitted to The Joint CommissionSurvey every two years led by an MT/CLS surveyor (Masters prepared or managerial background)Only non-waived services can be accreditedCould be main lab, POCT only, or bothOrganization could have more than one laboratory accreditor, e.g. main lab CAP, POCT The Joint CommissionHaving Joint Commission hospital accreditation does not mean the laboratory services are also Joint Commission accreditedSurvey every three years for hospitalsTeam of RN, MD, LSC, AdministratorNo technical elements of testing are reviewed
28 Which standards apply if there are Joint Commission accredited non-waived laboratory services? Laboratory standards manualNon-waived testing: All chapters apply, except WTCore chapters (identified on prior slide)Document Control (DC)Quality Systems Assessment – 3 sectionsProficiency testing – all apply (QSA – QSA )Systems standards – all apply (QSA – QSA )Specialty & subspecialty – specific groups apply, listed alphabetically (QSA – QSA )Example: Chemistry QSA – QSAWaived testing: APRs, NPSGs, LD , WT chapters applySurvey includes tissue, clinical transfusion practices and perioperative transfusion services
29 If organization & NONE of the non-waived laboratory services are Joint Commission Accredited: Laboratory should follow:Their non-waived laboratory accreditor’s requirements, e.g. CAP or COLA (surveyed every two years)The Joint Commission organizational standards (surveyed every three years)Waived testing requirementsFollow the most stringent requirements when standards vary between accreditorsOther clinical and hospital requirements related to lab service
30 If organization & SOME of the non-waived laboratory services are Joint Commission Accredited: Most common scenarioLaboratory should follow:The Joint Commission laboratory standards for services in which the organization applied, waived testing, tissue, clinical side of transfusion services, and perioperative transfusion services (surveyed every two years)The other laboratory accreditor’s requirements (CAP or COLA) for the services in which they applied for accreditation (surveyed every two years)The Joint Commission organizational standards (surveyed every three years)Waived testing requirementsFollow the most stringent requirements when standards vary between accreditorsOther clinical and hospital requirements related to lab service
31 If organization & ALL of the non-waived laboratory services are Joint Commission Accredited: Simplest scenarioThe Joint Commission Laboratory standards (surveyed every two years)The Joint Commission organizational standards (surveyed every three years)Sites currently evaluating the opportunity for concurrent organization and laboratory survey every six years (every other organizational survey)
32 When should we participate in the Periodic Performance Review? PPR SoftwareWeb enabled tool via secure extranetSelf-assessment—non-punitive processSubmitted annuallyPlans of Action / Measures of SuccessConference Call (Optional)Standards Interpretation Staff (SIG)Approval of POA and MOS
33 Completing the PPRAlways participate in the hospital’s PPR and the WT standards!And if the laboratory services are surveyed…Only by a Cooperative PartnerSupport the hospital’s PPR with completing related standardsParticipate in the partner’s self assessment processBy a combination of laboratory accreditorsComplete PPR review against the applicable standards in lab manual and support the related hospital standardsOnly by The Joint Commission
34 The E-dition and Organization Customized Standards (OCS)
39 Organization Customized Standards (OCS) Linked to specialties and services selected in applicationSelections in application populate Survey TechnologySurveyors apply only those standardsFuture – link application to E-dition?Standards Applicability Grid in manual for referenceAdvantages: Single set of standards, customizable based on specialty and service
40 2010 Standards “Changes” No changes to the actual requirements Standards Improvement InitiativeImproved clarityEliminated duplicationReformatted/renumberedNPSGs simplifiedNew chapter headingsDocument Control (DC)Emergency Management (EM)Transplant Safety (TS)
41 National Patient Safety Goals RetainedTwo Patient IdentifiersHand HygieneRevised (based on field input)Critical Reporting2010 goal is refocused on critical resultsCritical tests no longer surveyed as part of the goal
42 National Patient Safety Goals Moved to standardsVerbal results read-backDo Not Use abbreviationsHand-off communicationsRemovedModified Universal Protocol for bedside procedures (duplicates organization standard)Treat Healthcare Acquired Infection (HAI) as sentinel event (duplicates Sentinel Event policy)Patient involvement in care (duplicates organization standard)
43 Comparison of waived and non-waived testing requirements
44 Equivalent QC / Alternative QC Traditional QC uses external liquid controlsEquivalent QC (EQC) may use electronic or internal monitors, e.g. simulators, on-board or automated QCAlso known as Alternative QC (AQC), to differentiate from Electronic QCIf the system simulates two levels of controls, it can be used to meet Joint Commission daily QC requirements for both waived and non-waived testingElectronic “checks” are not sufficient
45 Equivalent QC (EQC) Requirements Joint Commission RequirementNon-waivedQSAWaived*WTInternal EQC minimumsABGs: 2 levels daily with one q8 hoursAll others: 2 levels once dailyAt least once dailyInitial evaluation of internal monitoring system to determine OptionOption 1Monitors entire analytical processOption 2Monitors portion of analytical processNot requiredInitial parallel validation of EQC vs. external QC10 consecutive testing days30 consecutive testing daysOngoing external QC - FrequencyOnce per calendar month & per lot and shipmentOnce per calendar week & per lot and shipmentPer manufacturer instructionor lab policyOngoing external QC - LevelsABGs: 3 levels (per QSA )All others: 2 levels*Use of Option 1 or 2 requirements exceeds the standards.
46 Competency Requirements Joint Commission RequirementNon-waivedHR & HRWaivedWTContentUse all six methodsBlind testingDirect observation of routine testingMonitoring QC performance (by each user)Written testingDirect observation of instrument checksMonitoring result reportingUse 2 of 4 methodsInitial training and annual assessmentYesSemiannual in 1st yearSignaturesDirector/supervisor must sign that the individual has received training and is competent prior to performing testing independentlyBoth the director/supervisor and the employee must sign that the individual has received training and is competent prior to performing testing independently46
47 Comparison of Requirements Joint Commission RequirementNon-waivedWaivedCLIA certificateYesCertificate of Accreditation (COA)Certificate of Waiver (COW)Establish P&PInitial training and annual competencySemiannual in 1st year2 levels of QC each day3 for ABGsReference intervals on patient chartQuantitative resultsCritical result reporting
48 Comparison of Requirements Joint Commission RequirementNon-waivedWaivedMethod validationYesNoEquivalent QC (EQC) validationSemiannual correlation studiesSemiannual calibration verificationProficiency testing(Or other verification procedure for nonregulated analytes)Regulated: 3x per yearNonregulated: Semiannual
49 Personnel Qualifications Continues to be an area of focusRecent years - emphasis on leadership rolesLaboratory Director (LD)Clinical Consultants (CC)Technical Supervisor (TS) and Technical Consultants (TC)General Supervisor (GS)Future - Anticipate added rigor for all rolesTIP: Laboratories must have records to demonstrate testing personnel meet the qualifications specified in CLIA at Subpart M.
50 Personnel Qualifications Qualification routes specify required education and experienceHigh complexity testing requires Associate’s degree or higher [42CFR (b)(1-7)]Moderate complexity testing requires high school diploma or higher [42CFR (b)(1-4)]Credentials requiring advanced degrees are not sufficient to demonstrate education, e.g. MT(ASCP), CLS (NCA) or R.N. license
51 Resources on the Web Centers for Medicare and Medicaid Services (CMS) CLIA:CoPs:Centers for Disease Control and Prevention (CDC)Food and Drug Administration CLIA Database SearchThe Joint Commission’sFrequently Asked Questions (FAQs)
53 Contact Us General information: Information on becoming accredited Your account executive (see your organization’s secure Extranet site for specifics)Information on becoming accreditedContact Jennifer RhamyPhone:Standards questionsContact Megan Sawchuk or Cherie UlaskasPhone: , Option 6Online: