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TJC – POCT “In Toto”

TJC – POCT “In Toto”. Meeting Joint Commission standards in the POC Laboratory Judy Gabriel, MT(ASCP) BS, MA Field Representative (Surveyor). Objectives. Understand what standards are applicable to your setting Learn common unmet standards Review resources for compliance

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TJC – POCT “In Toto”

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  1. TJC – POCT “In Toto” Meeting Joint Commission standards in the POC Laboratory Judy Gabriel, MT(ASCP) BS, MA Field Representative (Surveyor)

  2. Objectives • Understand what standards are applicable to your setting • Learn common unmet standards • Review resources for compliance • Introduce applicable new standards that take effect July 2011 • Get answers to the questions you’ve been eager to ask

  3. Toto, the reality finder

  4. Which of the standards apply to MY laboratory • What is a laboratory? • Any location that performs laboratory testing for patients • Does not apply to employee health • Be careful about drug testing in a substance abuse setting or for forensic purposes only • Waived testing only: mostly WT chapter standards, but EC or IC could apply and NPSG certainly • PPMP and non-waived: all chapters

  5. Frequently cited standards in Waived Chapter • WT.05.01.01: The org maintains records for WT. • EP 1: documentation of QC results • EP 3: reference ranges are included in the chart • EP 4: functional audit trail of patient result & associated QC results • WT.01.01.01: P/P written, approved, followed • manufacturer instructions are followed • Confirmatory testing performed

  6. More WT frequently findings • WT.03.01.01: competency of staff • Yearly • Two of four methods documented • Blind test • Observation • Monitoring of QC • Written test • All but WT.05.01.01 are direct impact EPs

  7. Latest on the cleaning of glucose meters • CDC recommendation: http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html • FDA letter to manufacturers 9/30/10 with similar information • Basically: one time use FS devices; gloves; multiuser meters clean between patients. Stay tuned for JC FAQ This would be scored under an IC Std if not WT.01.01.01

  8. PPMP or Non-waived Laboratories • All chapters apply • In the QSA chapter only the standards that are general or specialty specific apply • IMPORTANT: Does the laboratory have its own CLIA number or is it part of the main laboratory within the organization? This makes a difference.

  9. A POC Laboratory that is part of the main laboratory • Essentially you are a “section” of the main laboratory and all activities are incorporated in their overall plans e.g. PI monitors, Policies and Procedures, Reporting formats. • Be careful about copying procedures from the main laboratory as they may contain details or instructions that do not apply to you--just like Chemistry instructions are different from Microbiology instructions.

  10. Non-waived Laboratory that has its own CLIA certificate • Document Control (DC) chapter: • Written procedures • Collection of samples (change in July: combined 2 bullets) • Ordering of tests (new in July: contact info for “user” of test results + process to get missing order before testing) • Procedures for each test include 10 elements (if applicable). New in July: criteria for confirmatory testing. • NEW standard DC.02.01.03 in July: procedure for test system down time (could be instrument or no reagent/kit) • DC.01.03.01: maintain the 2 unique identifiers throughout the whole testing process

  11. More about the DC chapter • DC.02.03.01: report of results in the medical record • A frequently cited standard • Name & address of laboratory missing • Date & time the test resulted missing (availability of the information is not enough, must be part of the report) • Units and reference ranges missing • New in July: report must include sex of the patient and age or date of birth of the patient. • DC.02.04.01: Retaining records: New in July: • Amended report needs to clearly ID the change. • See also change at QSA.02.12.01 (notify orderer)

  12. Dorothy & Toto

  13. EC & IM Chapters • Lots of Direct Impact EPs in the EC chapter. Mostly covered for you by the organization, but if you are in a free standing facility, review to be sure all are covered. • New in July: EPs in EC.02.06.01: eye wash stations and no food or drink stored in work areas • IM chapter: no changes that affect POCT. But watch out for security of information (back up of computer information) Note: this issue requires a written policy

  14. HR Chapter • HR Standards: • Most frequently cited standard has to do with documented competency. There are six point that need to be addressed: • Direct observation of patient test performance • Report details • Preliminary reports, worksheets, QC, PT, PM • Direct observation of instrument maintenance • Direct observation of test performance • Problem solving skills • Other challenge is timing: original, 6 mos, yearly

  15. IC, LD, NPSG, PI Chapters • IC standards: common sense; nothing new for July • LD standards: NEW for July: • Written organization plan or chart • Re-write of EP 1 for LD.04.05.01: change to the Note: moved from IM chapter the requirement to have a list of laboratory test methods, performance specs and interfering factors • NPSGs: nothing new, just adhere to 2 unique IDs • PI: nothing new; be sure to have documented projects

  16. QSA Chapter (Quality System Assessment) • QSA.01…standards (5 of them): • 2 require written procedures • Include regulated and non-regulated analytes • Require comprehensive investigation of all scores less than 100% • Require testing material like & with patient samples • Require rotating among staff • These are on the most frequently cited standard list • No changes in July 2011

  17. More QSA • QSA. 02…(14 separate standards with LOTS of EPs • These standards include: • Validation of new test or new equipment (this includes loaner equipment) • Calibration verification aka reportable range validation. This is a most frequently cited standard. It is wise to also check the 2 EPs elsewhere that say the laboratory does not report outside of their validated range. I give this frequently for low level patient pO2s. Watch out for ACT & oximeter instruments; this standard includes them.

  18. More of what the QSA.02…include • The standard about instruments that have equivalent QC: the validation of and requirement for external QC. This is most often not done well for Blood Gas instruments. This also applies for non-waived, non-instrument based tests. • The standards about QC and the acceptable ranges for QC material • The standard about correlation of instruments, methods or locations for testing the same analyte. NEW in July: define target values and tolerance limits for the correlation • NEW in July: Changed results: notify orderer

  19. The rest of the story • The rest of the changes effective July 2011 involved specialties that would not be done as POCT. • The standards in the QSA chapter besides those already mentioned are generally in the Chemistry (QSA.06…), Urinalysis (QSA.07…), Hematology (QSA. 11…), PPMP (QSA.18…) or the Waived chapter.

  20. REFERENCES • CAMLAB: full standard book • 2011 Laboratory Accreditation Overview Guide • TJC web site • Accreditation –Laboratory • Standards—FAQs • The PPR product

  21. ???QUESTIONS???

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