Presentation on theme: "UNIVERSITY OF WISCONSIN MEDICAL SCHOOL"— Presentation transcript:
1 UNIVERSITY OF WISCONSIN MEDICAL SCHOOL Walk the Walk and Talk the Talk: Meeting the Inspector with Confidence!Sharon S. Ehrmeyer, Ph.D.UNIVERSITY OF WISCONSIN MEDICAL SCHOOLMADISON, WI
2 Successful Strategy #1 Know your inspection agency’s requirements!
3 Regulatory realityCLIA regulations must be met through accreditation with:CLIA,JCAHO, orCAP
4 General Regulatory Requirements Follow manufacturer’s protocolsValidate method before routine useAccuracy, precision, reportable range, etc.Have authorized operatorsInitial (documented) training and on-going competency assessmentInclude patient and operator identificationMonitor instrument functions
5 General Regulatory Requirements Perform required maintenancePerform and evaluate QC at appropriate intervalsPerform corrective actionsProvide an audit trailFrom testing to patient recordParticipate in regulatory proficiency testingDocument all informationQC, QA checks, PT results, maintenance, etc.
6 Who’s on first?What regulations to follow; who inspects depends on CLIA certificate arrangement:JCAHO accreditationAccepts CAP and COLA inspectionsReinspects waived POCT every 3 yearsCAP accreditationCAP must inspectCMS for CLIA complianceSites not seeking specific accreditation
7 CLIA’03 Final QC Regulations Good news!!Allows one survey cycle (2 years) to:Permit labs to complyCMS to develop revised surveyor/lab guidelinesBad news!!No comments solicitedRegulation is finalStill not complete; other subparts will followJudy Yost, CMS 2003
8 JCAHOComprehensive Accreditation Manual (Pathology and Clinical Laboratory Services)Beyond 2003
9 JCAHO – 2004 and beyond Draft of proposed standards at www.jcaho.org Goal with revisions:Eliminate redundanciesReduce documentation and paperworkFocus survey process on patient safety and health care quality15
10 JCAHO – 2004 and beyond JCAHO’s new accreditation model: More data drivenLess predictableMore customized to individual organizationFewer standards, but not reduced requirementsStandards’ wording revised to be better understandChange in basic formatIntent statement replaced with rationale and measurable characteristic (element of performance, e.g., there is a written policy that defines QC)Some standards are now “elements of performance”WT ( ) At a minimum, manufacturer’s instructions are followed.15
11 JCAHO – 2004 and beyondJCAHO’s new survey process – Shared Visions-New Pathways:Scoring changed from a 5 to a 3-point processNo percentage scoreFocus on lab functions – pre- through post-analytical15
12 Waived Testing ( )WT.1 Organization defines use of waived test results in patient care (definitively or only as a screen).WT.1.1 Organization identifies personnel responsible for performing and supervising waived testing.WT.1.2 Personnel performing tests have adequate, specific training and orientation to perform the tests, and demonstrate satisfactory levels of competence.WT.1.3 Policies and procedures governing specific testing-related processes are current and readily available.WT.1.4 QC checks, as defined by organization, are conducted on each procedure.WT At minimum, manufacturer’s instructions are followed.WT.1.5 Appropriate QC and test records are maintained.
13 Waived Testing ( )WT Organization defines use of waived test results in patient care (definitively or only as a screen).WT Organization identifies staff responsible for performing and supervising waived testing.WT Staff performing tests have adequate, specific training and orientation to testing and demonstrate satisfactory levels of competence.WT Approved policies and procedures governing testing processes are current and readily available.WT QC checks, as defined by the organization, are conducted on each procedure.WT Appropriate QC and test records are maintained.
14 WT -- Elements of performance (2004-2005) WT Organization defines use of waived test results in patient care (definitively or only as a screen).If test is used for screening, then confirmatory test is specified in procedure, if required WT Organization identifies staff responsible for performing and supervising waived testing.Each identified may be employees of the organization, contracted staff, or employees of a contracted service.
15 WT -- Elements of performance (2004-2005) WT Staff performing tests have adequate, specific training and orientation to testing and demonstrate satisfactory levels of competence.Competency assessments are based on frequency of staff performance of testing, technical background and skills, complexity of method and consequence of inaccurate resultsAssessment of skills include at least one of followingPerforming test on unknown sampleSupervisory or qualified person observe routine workMonitor QC performance
16 WT -- Elements of performance (2004-2005) WT Approved policies and procedures governing testing processes are current and readily available.Specimen collection, ID, and appropriate required labelingSpecimen preservation, as appropriateInstrument calibrationQC and remedial actionsEquipment performance evaluationTest performance
17 WT -- Elements of performance (2004-2005) WT QC checks, as defined by the organization, are conducted on each procedure.Written QC plan that specifies how procedures will be controlled for quality, establishes timetables, and explains rationaleQC checks conducted as specified in planFor glucose, 2 levels of QC are run each day of patient testingFor other methods, QC is based on how test is used, reagent stability, manufacturer’s recommendations, organizations experience with test, currently accepted guidelinesAt minimum, manufacturers’ instructions are followed
18 WT -- Elements of performance (2004-2005) WT Appropriate QC and test records are maintained.All QC results documentedAll test results are documentedQC records, instrument problems, and patient results correlatedFunctional audit trail maintained
19 QC – JCAHO (2002-2003) (QC.1) Documented QC program (QC.1.2) Validation of methods(QC.1.3) Daily surveillance of results(QC.1.4) Perform / document corrective actions(QC.1.5) Review QC results before reporting results(QC.1.6) Follow manufacturer’s reagent guidelines
20 2004 QC Standards (pre-publication) Proficiency TestingQC Each specialty and subspecialty has a documented QC program.QC PT services used for specialty and subspecialty equal or exceed CLIA regulatory requirementsQC Lab maintains a cumulative record of PT participation and includes documented review and evaluation of each unsatisfactory PT resultQC Lab ensures PT testing is performed in the same manner as patient sample testing.QC PT performance is maintained at an acceptable level.
21 2004 QC Standards (pre-publication) Quality Monitoring and Control SystemsQC Lab uses system for verifying accuracy and reliability of test results for tests not in regulatory PT.QC Lab’s QC system validates methods used.QC Lab uses system to evaluate and correlate relationship between results for same test performed with different methodologies/instruments or at different sites.QC Lab’s QC system includes daily and periodic result surveillance by appropriate staff.QC Lab takes remedial action for deficiencies identified by QC measures or authorized inspections and documents such actions.
22 2004 QC Standards (pre-publication) Quality Monitoring and Control Systems, cont.QC Lab ensures QC results meet criteria for acceptability before reporting patient test results.QC QC specimens are tested in same manner as patient samples.QC Lab follows written guidelines for properly preparing, storing, dispensing, and periodically evaluating all reagents, including water, to ensure accurate, precise results.QC Lab ensures reagents and solutions are completely and accurately labeled according to written guidelines.QC Laboratory retains QC records as required by law.
23 JCAHO – QC standards (2004 and beyond) Like for WT, each standard has elements of performance for guidance in meeting the standardSpecialty and subspecialty sections to follow (depends on testing performed)Clinical chemistryHematology and coagulationClinical microscopy (urinalysis)15
24 JCAHO – 2004 and Beyond Checkout proposed standards at: www.jcaho.org Also think about 100% compliance100% of timefor patient safety15
25 Successful Strategy #2 Apply the Regulations Identify Problems (Concerns) in YOUR laboratory 1
26 How? Be objective Do periodic mock reviews CAP Interim Self Survey JCAHO’s Preparation GuidelinesCOLAs inspection checklistInspection ChecklistConsultantsUse tracker tools
27 Mock Inspection – Gen. Information Is testing performed under an appropriate CLIA certificate?Central Laboratory or other (specify)____________Type of certificate - waived, mod. or high complexityExpiration date ________________Director named on certificate _________________Which agency inspects?JCAHOCAPCOLACMS (CLIA)Other (specify)_________
28 Mock Inspection -- QA QA Plan implemented and available to view? Director and supervisor signed off / approved?Monitors assure total quality care?Documentation of problems/resolutions?Accuracy verified for all analytes?Results correlated?with other methods / instrumentsComplaints and deficiencies logged and corrected?QA activities / reports show quality is built in?
29 Mock Inspection -- Personnel Director/supervisor meet CLIA qualifications and applicable state/local laws?Testing personnel authorized for specific testing?Received adequate training?Assessed, on a defined interval, for continued competency?Records, including training and competency assessment, maintained?
30 Mock Inspection -- Procedure manual The most current PM is available to staff?Dated when put in place?Updated with the latest product inserts?Reviewed and signed by the Director or designee initially (and every 2 years)?Old PMs for discontinued methods retained for at least 2 years?Testing personnel are familiar with its content?
31 Mock Inspection -- QC Established QC program that describes: frequency of QC and number of controls analyzed?acceptable limits?documentation of QC results?corrective action for values outside acceptable limits?corrective action for unacceptable controls and documentation?review of QC data including review of any corrective action reports?
32 Mock Inspection -- PTEnrolled in regulatory PT for the regulated tests?PT results reviewed and review documented (signed and dated)?Each failure investigated and corrective actions documented?Records maintained for appropriate time?
33 Mock Inspection -- Reagents Kept in original container?Stored as directed by manufacturer?If a specific temperature range is required, temperature must be monitored.Not used beyond indicated expiration dates?
34 Mock Inspection -- Lab safety Safety manual available to staff?Does it contain:general institutional requirements?instructions to minimize the risk of exposure to HIV, hepatitis, etc.?fire prevention and control?electrical safety?hazardous waste disposal including sharp/needle disposal?internal and external disaster plans?
35 Tracker Tools* to ID Problems System to evaluatePre-analytic processesAnalytic processesPost-analytic*Anne Belanger, MA, MT(ASCP)Consultant, Laboratory Accreditation
36 Tracker Tools* Specimen collection *Tools apply to all testing OrderingSpecimen collectionSpecimen processingSample testingResulting*Tools apply to all testing
37 Tracker Tools Ordering Specimen collection Right test ordered on right patient?How does the order get to the laboratory?Order is clear and legible?Polices and procedures for specimen collection?Specimen collectionSterile technique used to draw blood?Blood preserved properly in appropriate container?Blood collected at correct time?Specimen labeled adequately?
38 Tracker Tools Sample testing Adequate technical procedures available? Analysts attested to their familiarity with these?Specimen integrity and identification maintained?Specimen tested in a timely manner?Equipment maintained per manufacturer's instructions?QC performed and within acceptable limits?Corrective action taken for unacceptable QC results?Sample rerun as necessary?Results verified?
39 Tracker Tools Resulting Correct result noted in report? Result legible?Appropriate reference intervals included?Pertinent comments noted (e.g., hemolysis)?Result reported to doctor in a timely fashion?
41 Successful Strategy #3 Keep it simple; Work Smarter Don’t forget everything you learned by just focusing on the rules!1
42 Don’t get caught in the trap! Avoid common citations 1
43 Common citations Following manufacturer’s directions QC QA Perform at appropriate frequencyCorrective actions for out-of-control situationsQAHave a planMonitor for effectiveness2X / year, comparisons and accuracy assessmentsPersonnel competencyProficiency testingParticipationReview of resultsCorrective actionsDocumentation15
44 Fail-safe Inspection Tips Things that should never occur:Dirty laboratoryMessy storage areasUnsafe practicesPre through post-analyticalUncorrected old citationsAlways have a plan!Staff who are not in the loop
45 ADVICE FROM INSPECTED LABS Know and understand inspecting agency’s regulationsFollow to the “nth” degreeHave documentation for everythingHave all manuals, records and files current and understandableHave an overall plan that states the lab’s approach to QAEducate the staff -- everyone is on the same page
46 ADVICE FROM INSPECTED LABS With inspectors:Be courteousBe honestDon’t volunteer extra information, but don’t get “dingy”Be ready to explain the why and howDon’t argue, explain in writingWith areas of concern, ask for suggestionsBe professionalBe confident; act confident
47 INSPECTION DOs AND DON’T Don’t procrastinatePaperwork, personnel reviews, records, etc.Do maintain an up-to-date QA programDo come to the table preparedPrepare everyoneDon’t operate a “sloppy ship”Follow all rules – alwaysMake compliance a requirement for continued employment
48 INSPECTION DOs AND DON’T Don’t delegate inspection duties to unprepared staffUnknowledgeable staff communicating with the inspector is a disasterDo have an alternative plan if the assigned staff member (to be with inspector) becomes unavailableDo present an organized frontHave “private space” for inspector to review materials and documentation
49 Organized documentation Document, Document, DocumentInspectors don’t want to see that you have the ability to produce quality results, they want:PROOF OF A QUALITY OPERATIONDocumentation must be organized and easy to understand
50 Documentation -- Personnel Job descriptionsPersonnel records (including licenses as applicable)OSHA bloodborne pathogen testingHepatitis B vaccination record or declination formImmunization/health/accident/incident recordsOrientation/in-service/cont. education recordsPerformance evaluationsOrientation and competence assessment
51 Documentation- policies/procedures AdministrativeTechnicalSafetyGeneralFireDisasterChemical hygieneInfection control
52 Documentation- policies/procedures Specimen collectionComputer (including backup), as applicableProcedure manualsInpatient and outpatient recordsCQI activities
53 Documentation- records Test validation protocols and recordsProficiency testing results (2 years)Accuracy data, if not in PTQuality control resultsMethod correlation records
54 Documentation- records Function checks and calibration, maintenance, and repair records for all equipmentTemperature recordsonly when relevantregents must be stored at specified temperatureCorrective action records for PT, QC
55 After the inspectionFinal decision usually up to regulator's oversight function, e.g., its boardReview all citationsPerform follow up per regulator's guidelinesPrepare plan of correctionImplement needed correctionsProvide evidence to regulator per guidelinesKeep inspection ready