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Walk the Walk and Talk the Talk: Meeting the Inspector with Confidence! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MEDICAL SCHOOL MADISON, WI.

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Presentation on theme: "Walk the Walk and Talk the Talk: Meeting the Inspector with Confidence! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MEDICAL SCHOOL MADISON, WI."— Presentation transcript:

1 Walk the Walk and Talk the Talk: Meeting the Inspector with Confidence! Sharon S. Ehrmeyer, Ph.D. UNIVERSITY OF WISCONSIN MEDICAL SCHOOL MADISON, WI

2 Successful Strategy #1 Know your inspection agencys requirements!

3 CLIA regulations must be met through accreditation with: CLIA, JCAHO, or CAP Regulatory reality

4 General Regulatory Requirements Follow manufacturers protocols Validate method before routine use Accuracy, precision, reportable range, etc. Have authorized operators Initial (documented) training and on-going competency assessment Include patient and operator identification Monitor instrument functions

5 General Regulatory Requirements Perform required maintenance Perform and evaluate QC at appropriate intervals Perform corrective actions Provide an audit trail From testing to patient record Participate in regulatory proficiency testing Document all information QC, QA checks, PT results, maintenance, etc.

6 Whos on first? What regulations to follow; who inspects depends on CLIA certificate arrangement: JCAHO accreditation –Accepts CAP and COLA inspections –Reinspects waived POCT every 3 years CAP accreditation –CAP must inspect CMS for CLIA compliance –Sites not seeking specific accreditation

7 CLIA03 Final QC Regulations Good news!! Allows one survey cycle (2 years) to: –Permit labs to comply –CMS to develop revised surveyor/lab guidelines Bad news!! No comments solicited Regulation is final Still not complete; other subparts will follow ä Judy Yost, CMS 2003

8 JCAHO Comprehensive Accreditation Manual ( Pathology and Clinical Laboratory Services) Beyond 2003

9 JCAHO – 2004 and beyond Draft of proposed standards at Goal with revisions: Eliminate redundancies Reduce documentation and paperwork Focus survey process on patient safety and health care quality

10 JCAHO – 2004 and beyond JCAHOs new accreditation model: More data driven Less predictable More customized to individual organization Fewer standards, but not reduced requirements Standards wording revised to be better understand Change in basic format – Intent 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, manufacturers instructions are followed.

11 JCAHO – 2004 and beyond JCAHOs new survey process – Shared Visions-New Pathways: Scoring changed from a 5 to a 3-point process No percentage score Focus on lab functions – pre- through post- analytical

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, manufacturers 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 ( ) 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 ( ) 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 results Assessment of skills include at least one of following –Performing test on unknown sample –Supervisory or qualified person observe routine work –Monitor QC performance

16 WT -- Elements of performance ( ) WT Approved policies and procedures governing testing processes are current and readily available. Specimen collection, ID, and appropriate required labeling Specimen preservation, as appropriate Instrument calibration QC and remedial actions Equipment performance evaluation Test performance

17 WT -- Elements of performance ( ) 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 rationale QC checks conducted as specified in plan –For glucose, 2 levels of QC are run each day of patient testing –For other methods, QC is based on how test is used, reagent stability, manufacturers recommendations, organizations experience with test, currently accepted guidelines –At minimum, manufacturers instructions are followed

18 WT -- Elements of performance ( ) WT Appropriate QC and test records are maintained. All QC results documented All test results are documented QC records, instrument problems, and patient results correlated Functional audit trail maintained

19 QC – JCAHO ( ) (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 Testing QC Each specialty and subspecialty has a documented QC program. QC PT services used for specialty and subspecialty equal or exceed CLIA regulatory requirements QC Lab maintains a cumulative record of PT participation and includes documented review and evaluation of each unsatisfactory PT result QC 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 Systems QC Lab uses system for verifying accuracy and reliability of test results for tests not in regulatory PT. QC Labs 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 Labs 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 standard Specialty and subspecialty sections to follow (depends on testing performed) Clinical chemistry Hematology and coagulation Clinical microscopy (urinalysis)

24 JCAHO – 2004 and Beyond Checkout proposed standards at: Also think about 100% compliance 100% of time for patient safety

25 Successful Strategy #2 Apply the Regulations Identify Problems (Concerns) in YOUR laboratory

26 How? Be objective Do periodic mock reviews CAP Interim Self Survey JCAHOs Preparation Guidelines COLAs inspection checklist Inspection Checklist Consultants Use 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 complexity Expiration date ________________ Director named on certificate _________________ Which agency inspects? – JCAHO – CAP – COLA – CMS (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 / instruments Complaints 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 -- PT Enrolled 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 evaluate Pre-analytic processes Analytic processes Post-analytic *Anne Belanger, MA, MT(ASCP) Consultant, Laboratory Accreditation

36 Tracker Tools* Ordering Specimen collection Specimen processing Sample testing Resulting *Tools apply to all testing

37 Tracker Tools Ordering 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 collection Sterile 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?

40 Fix Problems Identified Prioritize Assign Correct

41 Successful Strategy #3 Keep it simple; Work Smarter Dont forget everything you learned by just focusing on the rules!

42 Dont get caught in the trap! Avoid common citations Dont get caught in the trap!

43 Common citations Following manufacturers directions QC –Perform at appropriate frequency –Corrective actions for out-of-control situations QA –Have a plan –Monitor for effectiveness 2X / year, comparisons and accuracy assessments Personnel competency Proficiency testing –Participation –Review of results –Corrective actions Documentation

44 Fail-safe Inspection Tips Things that should never occur: Dirty laboratory Messy storage areas Unsafe practices – Pre through post-analytical Uncorrected old citations – Always have a plan! Staff who are not in the loop

45 ADVICE FROM INSPECTED LABS Know and understand inspecting agencys regulations Follow to the nth degree Have documentation for everything Have all manuals, records and files current and understandable Have an overall plan that states the labs approach to QA Educate the staff -- everyone is on the same page

46 ADVICE FROM INSPECTED LABS With inspectors: Be courteous Be honest –Dont volunteer extra information, but dont get dingy Be ready to explain the why and how –Dont argue, explain in writing –With areas of concern, ask for suggestions Be professional Be confident; act confident

47 INSPECTION DOs AND DONT Dont procrastinate Paperwork, personnel reviews, records, etc. Do maintain an up-to-date QA program Do come to the table prepared Prepare everyone Dont operate a sloppy ship Follow all rules – always Make compliance a requirement for continued employment

48 INSPECTION DOs AND DONT Dont delegate inspection duties to unprepared staff Unknowledgeable staff communicating with the inspector is a disaster Do have an alternative plan if the assigned staff member (to be with inspector) becomes unavailable Do present an organized front Have private space for inspector to review materials and documentation

49 Organized documentation Document, Document, Document Inspectors dont want to see that you have the ability to produce quality results, they want: PROOF OF A QUALITY OPERATION Documentation must be organized and easy to understand

50 Documentation -- Personnel Job descriptions Personnel records (including licenses as applicable) OSHA bloodborne pathogen testing Hepatitis B vaccination record or declination form Immunization/health/accident/incident records Orientation/in-service/cont. education records Performance evaluations Orientation and competence assessment

51 Documentation- policies/procedures Administrative Technical Safety General Fire Disaster Chemical hygiene Infection control

52 Documentation- policies/procedures Specimen collection Computer (including backup), as applicable Procedure manuals Inpatient and outpatient records CQI activities

53 Documentation- records Test validation protocols and records Proficiency testing results (2 years) Accuracy data, if not in PT Quality control results Method correlation records

54 Documentation- records Function checks and calibration, maintenance, and repair records for all equipment Temperature records only when relevant – regents must be stored at specified temperature Corrective action records for PT, QC

55 After the inspection Final decision usually up to regulator's oversight function, e.g., its board Review all citations Perform follow up per regulator's guidelines Prepare plan of correction Implement needed corrections Provide evidence to regulator per guidelines Keep inspection ready


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