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TJC – POCT “In Toto”Meeting Joint Commission standards in the POC Laboratory

Judy Gabriel, MT(ASCP) BS, MA Field Representative (Surveyor)

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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

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Toto, the reality finder

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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

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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

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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

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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

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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.

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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.

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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

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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)

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Dorothy & Toto

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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

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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

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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

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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

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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.

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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

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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.

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REFERENCES

CAMLAB: full standard book

2011 Laboratory Accreditation Overview Guide

TJC web site– Accreditation –Laboratory– Standards—FAQs

The PPR product

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???QUESTIONS???