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  Tips for Avoiding Proficiency Testing Referral
  Frequently Asked Questions

  e-Alert

Updated April 18, 2014

Why is the College of American Pathologists (CAP) offering Proficiency Testing (PT) referral guidance?
What does it mean to treat PT like a patient?
May a reference laboratory accept a PT specimen from one of its laboratory clients?
Are there requirements regarding the training of the staff with regard to PT?
Who do I contact if I still have questions?

Why is the College of American Pathologists (CAP) offering Proficiency Testing (PT) referral guidance?

CAP has tracked an increase in unintentional incidents of PT referral leading to the conclusion that some laboratories may not have a clear understanding of the regulation and activities that may violate the rule. To help protect CAP accredited laboratories, the CAP is working to clear up that confusion.
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What does it mean to treat PT like a patient?

The Clinical Laboratory Improvement Amendments (CLIA) law and regulations (section 493.801) require that all laboratories enroll in approved proficiency testing programs. In addition, the laboratory “must test [proficiency testing] samples in the same manner as [the laboratory] tests specimens.” This means that personnel who routinely perform the testing should test PT samples with the laboratory’s regular workload. As an example, if a laboratory tests a patient specimen only once, then PT specimens also must be run only one time, not in duplicate. It also means that the testing of PT samples should be rotated among all staff members who routinely perform the patient testing.
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May a reference laboratory accept a PT specimen from one of its laboratory clients?

No. The rule against PT referral also applies to reference laboratories receiving PT specimens from another laboratory. A laboratory may not accept a specimen for testing from another laboratory if the specimen appears to be a proficiency testing sample. Reference laboratories are encouraged to develop written criteria for recognizing referred PT samples. The reference laboratory must notify CAP and CMS if it receives an improperly referred PT specimen.
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Are there requirements regarding the training of the staff with regard to PT?

Yes, checklist item COM.01900 requires that laboratories have a policy prohibiting referral of PT to another laboratory or accepting PT from another laboratory. Staff involved in the PT process should be trained regarding the contents of this policy, and documentation of this training is highly recommended. Regulations regarding the handling, testing and reporting of PT are complex and can be violated unintentionally if not well understood.
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Who do I contact if I still have questions?

The Laboratory Accreditation Program of the CAP is committed to assisting its accredited laboratories with critical accreditation information. The CAP can assist you with any of the regulations set forth by CMS to maintain continuous compliance and quality patient testing. Contact the CAP with any questions you may have at accred@cap.org or (1-800)323-4040, Option 1. If you have specific questions regarding a PT sample, you may also want to contact your PT provider.
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Examples of Scenarios That Have Caused Lab Sanctions and How to
Avoid Them
Scenario One
A laboratory director works with two laboratories, one a hospital laboratory (Lab A) and the other an esoteric laboratory (Lab B). Both are under the same ownership and operations between the two are standardized. However, the laboratories are at 2 different addresses and have different CLIA numbers. Components of tests and some reflex testing are performed at the two laboratories. For example, total serum protein is performed at Lab A, but not protein electrophoresis; protein electrophoresis is performed at Lab B but Lab B uses the total protein performed at Lab A to quantify the fractionated protien.
How to Treat a Patient Sample
Both results may be used to quantify each protein factor.
How to Treat a PT Sample
Lab A would need to be enrolled in a proficiency testing product for total protein as that is the testing that the laboratory performs. Lab B would need to identify a cost-effective means to perform a total protein if needed for reporting out the electrophoresis PT results.

PT samples and data generated from the samples cannot be shared between Lab A and Lab B.

Each site must be enrolled separately based on location and only for testing that is performed at the location of the laboratory.

Scenario Two
Reflex and Confirmatory Testing

For example: reflex (HIT ELISA/HIT SRA) and confirmatory (blood culture/Gram stain) testing

How to Treat a Patient Sample
If a laboratory does not perform the confirmatory or reflex test based on the initial test result the sample would typically be sent to a different, reference laboratory for that testing.
How to Treat a PT Sample
A laboratory should report PT results for the initial testing that is done in that laboratory. If the laboratory does not perform the confirmatory or reflex testing, then the laboratory should refer to the PT providers kit instructions on how to record a result for a test not performed in this laboratory as appropriate. The laboratory is prohibited from sending the PT sample to another laboratory.

All results and signatures must be confined to the site with the same CLIA number in which the PT sample was received.

Scenario Three
Slides for Pathologist Review:
A laboratory is in one state and its pathologist is located in another and visits only once a quarter. “When the slide requires a pathologist’s review, I can send the slides for him to review. We do that with patients when we get slides that fit the requirements for his review. It would not be practical for him to fly up here for that.”

How to Treat a Patient Sample
Certain patient slides like abnormal differentials or abnormal body fluid samples require a pathologist’s review. These slides may be sent (via courier or mail) to the pathologist at a site outside of the testing laboratory for review.

Patient samples may be referred and reviewed off-site. Patient reports must define where the diagnosis was rendered. It must be documented as a referred sample by the referring laboratory.

How to Treat a PT Sample
For proficiency testing samples, it is not acceptable to send the slides out to the pathologist for review at his/her remote location. Such an action may appear to be PT referral and may result in CMS sanctions.

If the pathologist cannot review the PT slide on-site, proficiency test results should be reported as “abnormality recognized; would refer.”

Scenario Four
A laboratory director directs five laboratories and is asked to review a photomicrograph for abnormalities from Laboratory A while the director works at Laboratory B.
How to Treat a Patient Sample
Review and report as the laboratory normally would. However, the name of the laboratory where the diagnosis was rendered must be documented on the final patient report.
How to Treat a PT Sample
For PT samples of this nature, the medical director must physically visit each site and review each case as requested. If this is not possible, then the laboratory performing the PT testing must select an appropriate response such as “abnormalityrecognized; would refer.”

To Emphasize: PT samples cannot be referred from one CLIA licensed laboratory to a laboratory with a different CLIA certificate.

Scenario Five
A laboratory is in a remote location and is provided consultative support electronically.
How to Treat a Patient Sample
Electronic consultations and signatures are acceptable.
How to Treat a PT Sample
Site visits by a consulting pathologist may be coordinated with the receipt of the PT shipments because the PT needs to be performed and signed at the location of the laboratory receiving the PT. Consultation of PT samples cannot be done electronically and the results cannot be signed electronically.

If the laboratory personnel encounters a proficiency testing sample that normally would not be able to be reported, and would be referred to a pathologist, it may be appropriate to report a result as “would refer” if the pathologist is unable to be physically on-site to review.

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