TJC – POCT “In Toto” Meeting Joint Commission standards in the POC Laboratory Field Representative (Surveyor) © Joint Commission Resources Judy Gabriel, MT(ASCP) BS, MA 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 ask © Joint Commission Resources Get answers to the questions you’ve been eager to © Joint Commission Resources Toto, the reality finder 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, PPMP and non-waived: all chapters © Joint Commission Resources but EC or IC could apply and NPSG certainly 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 © Joint Commission Resources – manufacturer instructions are followed – Confirmatory testing performed 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 © Joint Commission Resources All but WT.05.01.01 are direct impact EPs Latest on the cleaning of glucose meters CDC recommendation: http://www.cdc.gov/injectionsafety/blood-glucosemonitoring.html FDA letter to manufacturers 9/30/10 with similar information Basically: one time use FS devices; gloves; multiuser This would be scored under an IC Std if not WT.01.01.01 © Joint Commission Resources meters clean between patients. Stay tuned for JC FAQ 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 © Joint Commission Resources organization? This makes a difference. 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 different from Microbiology instructions. © Joint Commission Resources do not apply to you--just like Chemistry instructions are Non-waived Laboratory that has its own CLIA certificate Document Control (DC) chapter: – Written procedures – DC.01.03.01: maintain the 2 unique identifiers throughout the whole testing process © Joint Commission Resources • 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) 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. – Amended report needs to clearly ID the change. – See also change at QSA.02.12.01 (notify orderer) © Joint Commission Resources DC.02.04.01: Retaining records: New in July: © Joint Commission Resources Dorothy & Toto 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 information) Note: this issue requires a written policy © Joint Commission Resources out for security of information (back up of computer 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.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 PI: nothing new; be sure to have documented projects © Joint Commission Resources NPSGs: nothing new, just adhere to 2 unique IDs 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 No changes in July 2011 © Joint Commission Resources These are on the most frequently cited standard list More QSA QSA. 02…(14 separate standards with LOTS of EPs – 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 These standards 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 nonwaived, 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 More of what the QSA.02…include 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 © Joint Commission Resources (QSA. 11…), PPMP (QSA.18…) or the Waived chapter. REFERENCES CAMLAB: full standard book 2011 Laboratory Accreditation Overview Guide TJC web site – Accreditation –Laboratory – Standards—FAQs © Joint Commission Resources The PPR product © Joint Commission Resources ???QUESTIONS???