TJC – POCT “In Toto” Judy Gabriel, MT(ASCP) BS, MA 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 Introduce applicable new standards that take effect July 2011 Get answers to the questions you’ve been eager to ask

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, but EC or IC could apply and NPSG certainly PPMP and non-waived: all chapters

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 Confirmatory testing: If you have defined the test as a screening test, then there should be a confirmatory test. If the test stands by itself and no further testing has to be done and treatment or diagnosis is based on that testing then confirmatory testing does not need to be done. Be careful about RSS; manufacturer’s required confirmation of negatives and we do too unless you have proven otherwise. We will ask for the documentation of the “otherwise.”

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 Do you know what “Direct Impact” means?

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

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.

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. The main laboratory should have a section within general policies and procedures that apply to POCT. Example: Cal ver will be different product from those used for chemistry analyzer or hematology analzyer. Since the standard requiring written instructions calls for including material used, the document needs to include what is used for blood gases (performed in RT). If CMS does a validation survey they will look at all places that non-waived testing is done under a particular CLIA number. Titles, responsibilities for compliance etc are moot to them; it is ALL the responsibility of the Director (whose name is on that CLIA certificate)

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 I will hit highlights i.e. those things that I have observed as problems. This in NOT all inclusive, but a help to avoid some pitfalls. I will go through each chapter for examples.

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)

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 out for security of information (back up of computer information) Note: this issue requires a written policy

Other challenge is timing: original, 6 mos, yearly 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 What is difference between 1 & 5 you ask?? 1 includes patient prep, spec collection, specimen handling & processing, test performance. 5 is test performance only as seen by org definition e.g. previously tested sample, internal blind sample, PT or original sample. NOTE: not all of these need to be observed at once. Remember QSA.02.11.01 (review of results). Your doing so is the fuel for these bullet points. Challenge is to document when each employee does well. Nothing new for July 2011

IC standards: common sense; nothing new for July 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 This is an adjunct to the requirement to LD.04.05.01 EP 9: the director makes available the basis of reference intervals (NV) upon request. In other words : where did the normal values come from? Why not have a file or spread sheet that has both sets of info?

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

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.

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 Check out my package insert for Amnio-Sure: this is a non-waived, non-instrument test w/built in QC I think…

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.

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

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