Proficiency Testing

Technical Consultant:
State Laboratory Director:
S
4/18/06
4/18/06
Site Co-Director :
________________________________________
Sign & Date
Procedure approved for initial implementation on ________________
Date
( ) Reviewed ( ) Revised: _______________________________
TC,Director, & Co- Director Initial & Date
( ) Reviewed ( ) Revised: _______________________________
TC,Director, & Co- Director Initial & Date
( ) Reviewed ( ) Revised: _______________________________
TC,Director, & Co- Director Initial & Date
( ) Reviewed ( ) Revised: _______________________________
TC,Director, & Co- Director Initial & Date
( ) Reviewed ( ) Revised: _______________________________
TC,Director, & Co- Director Initial & Date
Local Public Health Laboratories of Kentucky
Proficiency Testing- PPM
I. Purpose and Principle
Proficiency testing is a method of externally validating the accuracy of laboratory
performance by testing samples and comparing results of all participating
laboratories. A proficiency testing provider sends samples to participants who have
enrolled in the program. The participants analyze the samples as they do patient
samples and return the results to the PT provider. The results are tabulated and
evaluated and scored reports are sent back to the laboratory.
A subcategory of the Moderate Complexity level was added after the original CLIA
publication. It was first described as Physician Performed Microscopy and is now
called Provider Performed Microscopy (PPM). The criteria for classifying these tests
include:
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• The examination must be performed by a physician or a mid-level practitioner
(i.e., nurse practitioners, nurse midwives and physician assistants) during the
patient visit on a specimen obtained from the provider's patient or a patient of the
group practice.
• The procedure must be in the moderately complex category.
• The primary instrument for the test must be a microscope.
• The specimen must be labile or a delay in testing could compromise the accuracy
of the test.
• Control materials are not available to monitor the entire testing process.
• Limited specimen handling is required.
The 42 CFR 493 - October 2001 indicates that PPM laboratories are subject to
Subparts H (Proficiency Testing), J (Patient test Management), K (Quality Control),
M (Personnel), and P (Quality Assurance). Because the PPM tests are considered
"non-regulated," proficiency testing is not specifically required, but a laboratory is
responsible for documenting quality assurance. In other words, at a minimum, two
split samples for each PPM test should be done yearly. Since split sampling would
not be feasible for most sites, the Local PHLOK is directed to perform proficiency
testing sent twice a year from the State Public Health Laboratory Technical
Consultant.
II.
Procedural Instructions
Proficiency Testing Procedure
1. Each site performing PPM testing will receive twice a year, proficiency testing
material from the State Technical Consultant. This material is in the form of
photomicrographs obtained from the Wisconsin State Laboratory of Hygiene
Proficiency Testing.
2. View the images and identify the structures that the arrows are pointing to.
Beginning April 2006, the State Laboratory will begin sending 5 challenges with
each mailing instead of 4 for KOH/Wet Preps. Use the information provided in
the case histories to aid identification.
3. Record your test results on the Provider Performed Microscopy (PM) Result
Form. Use the “Microscopic Glossary” provide on the Provider Performed
Microscopy (PM)/Urine Sediment (SU) Instructions form to obtain code numbers
for the urine sediment and wet prep challenges. Select the appropriate response
codes from the glossary and enter them on the result form. For all other
microscopic procedures, mark an appropriate response circle on the result form. If
you do not perform a particular procedure, fill in the “Test not performed” circle.
4. Sites performing any of the Microscopic Procedures listed on the Provider
Performed Microscopy (PM) Result Form need to complete the Proficiency
Testing for those tests.
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5. Obtain signature of Co-Director and testing personnel and complete the
Attestation Statement Form.
6. Mail results back to the State Public Health Laboratory within 5 days in the
provided envelope.
7. The State Technical Consultant will mail back to your site a copy of your results
and the expected results along with an event specific information data form
complied by Wisconsin State Hygiene Laboratory from all sites that submit
testing results.
8. If your site receives a score less than 80%, remedial action must be taken,
documented and documentation sent to the State Lab Technical Consultant.
CLIA Regulations to Support Proficiency testing
493.801
Subpart H
Testing of Proficiency Specimen
1. The laboratory must examine or test, as applicable, the proficiency testing
samples it receives from the proficiency testing program in the same manner as
it tests patient specimens.
2. The samples must be examined or tested with the laboratory's
regular patient workload by personnel who routinely perform the testing in the
laboratory, using the laboratory's routine methods. The individual testing or
examining the samples and the laboratory director must attest to the routine
integration of the samples into the patient workload using the laboratory's routine
methods.
3. Laboratories that perform tests on proficiency testing samples must not engage in
any inter-laboratory communications pertaining to the results of proficiency
testing sample(s) until after the date by which the laboratory must report
proficiency testing results to the program for the testing event in which the
samples were sent. Laboratories with multiple testing sites or separate locations
must not participate in any communications or discussions across sites/locations
concerning proficiency testing sample results until after the date by which
the laboratory must report proficiency testing results to the program.
4. The laboratory must document the handling, preparation, processing,
examination, and each step in the testing and reporting of results for all
proficiency testing samples. The laboratory must maintain a copy of all records,
including a copy of the proficiency testing program report forms used by the
laboratory to record proficiency testing results including the attestation statement
provided by the PT program, signed by the analyst and the laboratory
director, documenting that proficiency testing samples were tested in the
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same manner as patient specimens, for a minimum of two years from the date
of the proficiency testing event.
493.803
Subpart H
Failure to Participate
1. Each laboratory performing nonwaived testing must successfully participate in a
proficiency testing program approved by CMS, if applicable, as described in subpart I
of this part for each specialty, subspecialty, and analyte or test in which the laboratory
is certified under CLIA. Except as specified in paragraph (c) of this section, if
a laboratory fails to participate successfully in proficiency testing for a given
specialty, subspecialty, analyte or test, as defined in this section, or fails to take
remedial action when an individual fails gynecologic cytology, CMS imposes
sanctions, as specified in subpart R of this part.
2. If a laboratory fails to perform successfully in a CMS-approved proficiency testing
program, for the initial unsuccessful performance, CMS may direct the laboratory to
undertake training of its personnel or to obtain technical assistance, or both, rather
than imposing alternative or principle sanctions except when one or more of
the following conditions exists:
(1) There is immediate jeopardy to patient health and safety.
(2) The laboratory fails to provide CMS or a CMS agent with
satisfactory evidence that it has taken steps to correct the
problem identified by the unsuccessful proficiency testing performance.
(3) The laboratory has a poor compliance history.
493.825
Subpart H
Unsatisfactory performance and remedial actions
1. Failure to attain an overall testing event score of at least 80 percent is
unsatisfactory performance.
2. Failure to participate in a testing event is unsatisfactory performance and results
in a score of 0 for the testing event.
3. Failure to return proficiency testing results to the proficiency testing program
within the time frame specified by the program is unsatisfactory performance and
results in a score of 0 for the testing event.
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4. For any unsatisfactory testing event for reasons other than a failure to participate,
the laboratory must undertake appropriate training and employ the technical
assistance necessary to correct problems associated with a proficiency testing
failure.
5. Remedial action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of participation in the
proficiency testing event.
6. Failure to achieve an overall testing event score of satisfactory performance for
two consecutive testing events or two out of three consecutive testing events is
unsuccessful performance. The site must then demonstrate sustained satisfactory
performance on two consecutive proficiency testing events, one of which may be
on site. Failure to resolve remedial action will be under special review by the
Director.
Investigating an Unacceptable PT Result
1. All documentation should be reviewed.
2. Personnel who processed or tested the specimen, and who transcribed results
should be interviewed. The investigation should include:
• Checks for clerical errors
• Review of records of quality control, calibration status and instrument
function checks
• Repeat analysis and calculations when possible
• Evaluation of the laboratory’s historical performance for that analyte
3. The laboratory should review patient data from the time of the unacceptable PT
result, to determine whether the problem could have affected patient care. If so,
appropriate follow-up action should be documented.
4. The laboratory should make every effort to find the cause(s) of an unacceptable
result. In instances where the laboratory can identify an underlying system
problem that contributed to the unacceptable result, actions to improve laboratory
systems will minimize the risk of recurrence and potentially improve the quality
of patient results.
5. The investigation, conclusions, and corrective action should be thoroughly
documented. For standardized form for reporting the results of every unacceptable
PT investigation, use the Corrective Action/Incident Reporting form found in
Section 7.
III. References
Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and
Laboratory Services, CMS Website, http://www.phppo.cdc.gov/clia/regs/toc.aspx,
accessed April 2006
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Using Proficiency Testing (PT) to Improve the Clinical Laboratory; Approved Guideline,
NCCLS GP27-A, Vol. 19, No, 15, 940 West Valley Road, Wayne, PA, 19087, 1999
Provider-Performed Microscopy Testing; Approved Guideline, NCCLS HS2-A, Vol. 20
No.3, 940 West Valley Road, Wayne, PA, 19087, 2003
Wisconsin State Hygiene Laboratory Proficiency Testing Program,
http://www.slh.wisc.edu/pt/, 465 Henry Mall: Room 402,
Madison WI 53706-1578, accessed April 2006
American Academy of Family Physicians Proficiency Testing, P.O. Box 11210
Shawnee Mission, KS 66207-1210, http://www.aafp.org/x2255.xml, accessed April 2006
IV. Author
Linda Dailey, MT (ASCP) April 2006
V. Procedure Policy, Approval and Review Process
1. The official copy of each procedure will be placed in the Technical and
Administrative Branch Manager’s copy of the Local Public Health Laboratory of
Kentucky Standard Operating Procedures Manual. A copy of the procedure to be
placed in the SOPM at each PHLOK approved site.
2. Each procedure will be initially reviewed and approved with signature by the
Technical Consultant, State Director and Co-Director prior to implementation.
3. Each procedure will be reviewed annually and as needed for necessary revision. Any
modification will be reviewed and approved as stated in #2 above.
4. Implementation of new or revised procedures must be communicated to all testing
personnel prior to the implementation date. The Co-Director must document that
each of the testing personnel (by individual name) have been made aware of the
procedure changes, revision implementation date and been trained as necessary.
5. Any associated logs, specimen collection instructions or other documents related to
the procedure change must be initiated.
6. Each procedure must have a master file, stored at the State Lab, that contains the
current and all previous versions. The master file serves as the documented history of
the procedure, showing all revisions and the dates used and discontinued or retired.
The master file must be maintained for a least two (2) years from last date used.
VI. Appendix
Copy of Provider Performed Microscopy (PM)/ Urine Sediment (SU) Instructions
Copy of Provider Performed Microscopy (PM) Result Form
Copy of Urinalysis & Microscopy Attestation/Comments Page
Copy of Provider Performed Microscopy (PM) photomicrographs
Copy of Performance Evaluation by Site
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