TJC – POCT “In Toto”
Meeting Joint Commission standards in the POC
Laboratory
Field Representative (Surveyor)
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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
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 Get answers to the questions you’ve been eager to
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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
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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
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– manufacturer instructions are followed
– Confirmatory testing performed
More WT frequently findings
 WT.03.01.01: competency of staff
– Yearly
– Two of four methods documented
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Blind test
Observation
Monitoring of QC
Written test
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 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
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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
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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.
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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
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• 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)
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 DC.02.04.01: Retaining records: New in July:
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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
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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
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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
 PI: nothing new; be sure to have documented projects
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 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
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 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.
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 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
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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
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(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
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 The PPR product
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???QUESTIONS???