TJC POCT In Toto Meeting Joint Commission standards

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 © Joint Commission Resources § Get answers to the questions you’ve been eager to ask

© 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 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: 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: P/P written, approved, followed © Joint Commission Resources – manufacturer instructions are followed – Confirmatory testing performed

More WT frequently findings § WT. 03. 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 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 © 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 do not apply to you--just like Chemistry instructions are © Joint Commission Resources different from Microbiology instructions.

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 p. O 2 s. 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 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 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

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