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© Joint Commission Resources TJC – POCT In Toto Meeting Joint Commission standards in the POC Laboratory Judy Gabriel, MT(ASCP) BS, MA Field Representative (Surveyor)
© Joint Commission Resources 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 youve been eager to ask
© Joint Commission Resources Toto, the reality finder
© Joint Commission Resources 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
© Joint Commission Resources Frequently cited standards in Waived Chapter WT : 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 : P/P written, approved, followed –manufacturer instructions are followed –Confirmatory testing performed
© Joint Commission Resources More WT frequently findings WT : competency of staff –Yearly –Two of four methods documented Blind test Observation Monitoring of QC Written test All but WT are direct impact EPs
© Joint Commission Resources Latest on the cleaning of glucose meters CDC recommendation: monitoring.html 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
© Joint Commission Resources 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.
© Joint Commission Resources 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.
© Joint Commission Resources 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 in July: procedure for test system down time (could be instrument or no reagent/kit) –DC : maintain the 2 unique identifiers throughout the whole testing process
© Joint Commission Resources More about the DC chapter DC : 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 : Retaining records: New in July: –Amended report needs to clearly ID the change. –See also change at QSA (notify orderer)
© Joint Commission Resources Dorothy & Toto
© Joint Commission Resources 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 : 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
© Joint Commission Resources 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
© Joint Commission Resources 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 : 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
© Joint Commission Resources 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
© Joint Commission Resources 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.
© Joint Commission Resources 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
© Joint Commission Resources 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.
© Joint Commission Resources REFERENCES CAMLAB: full standard book 2011 Laboratory Accreditation Overview Guide TJC web site –Accreditation –Laboratory –StandardsFAQs The PPR product
© Joint Commission Resources ???QUESTIONS???
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