College of American Pathologists
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  Tips for Avoiding Proficiency Testing Referral
  Frequently Asked Questions

  e-Alert

Updated September 26, 2017

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 continues to track unintentional incidents of PT referral. Some laboratories may not have a clear understanding of the CMS regulation and activities that may violate the rule. The CAP is providing guidance to help protect CAP accredited laboratories and avoid severe penalties
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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 before reporting, then PT specimens also must be run only one time, not in duplicate, before reporting. 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 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 PT sample. Referral laboratories are encouraged to develop written criteria for recognizing referred PT samples. The referral laboratory must notify CMS and CAP if it receives an improperly referred PT specimen.

(Note: A laboratory may accept PT slides for IHC staining only because IHC staining is not a test per CMS. See scenario six.)
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Are there requirements regarding the training of the staff with regard to PT?

Yes, checklist item COM.01900 requires 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 to 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 CAP Accreditation Program staff is committed to assisting accredited laboratories with critical accreditation information. Contact the CAP with any questions you may have at accred@cap.org or (800) 323-4040, Option 1. If you have a specific question regarding a PT sample, you may also want to contact the 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 CAP/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 and protein electrophoresis is performed by Lab B by using the total serum protein result from Lab A.
How to Treat a Patient Sample
Lab A would report total serum protein and send the patient sample to Lab B for the protein electrophoresis.
How to Treat a PT Sample
Lab A would need to enroll in a proficiency testing product for total protein and report the total protein the laboratory performs. Lab B would be unable to report any PT result that would require the total protein. Contact your PT provider or accrediting agency for advice in these situations.

PT samples and data generated from the PT 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 Heparin-Induced Thrombocytopenia (HIT) ELISA/HIT Serotonin Release Assay (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 that is indicated and/or required as a result of an initial test result, the sample would typically be sent to a different, referral 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 Provider kit instructions on how to record a result for a test not performed in the laboratory. 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 CAP/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 or to provide consultative support electronically. We do that with patients when we get slides that fit the requirements for his/her review. It would not be practical for him/her 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 this review.

Patient samples may be referred and reviewed offsite. Patient reports must define where the diagnosis was rendered. The report must be documented as a referred sample by the referring laboratory. Electronic consultations and signatures are acceptable.

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. 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 PT sample that normally would not be able to be reported, and would be referred to a pathologist, then the laboratory should refer to the PT Provider kit instructions on how to record a result for a test not performed in the laboratory if the pathologist is unable to be physically on site to review.

Scenario Four
Your pathologist is the laboratory director of five laboratories and is asked to review a photomicrograph for abnormalities from Lab A while he/she works at Lab 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 should refer to the PT Provider kit instructions on how to record a result for a test not performed in the laboratory.
Scenario Five
Lab A sends HER2 and/or ER/PgR samples/slides to Lab B (off-site laboratory) for IHC staining and image analysis. Interpretation is performed at Lab A. Ensure Lab A’s activity menu reflects interpretation only, off-site staining.
How to Treat a Patient Sample
Lab A sends HER2 and/or ER/PgR samples/slides to Lab B for IHC staining and image analysis as this is not done on-site. Lab A will review and report the interpretation results.
How to Treat a PT Sample
For the tissue challenges in the HER2 and PM2 Surveys, Lab A should send the slides to Lab B for staining only (Per CMS staining is not a test so this practice is acceptable). Lab A should not request quantitative image analysis at the outside facility even if this is routinely done for patient testing. Doing so could be considered PT Referral and result in severe sanctions by CMS. Lab A must report the results of manual scoring for these PT slides.

Scenario Six
Lab A interprets and reports the results of ISH testing (eg, HER2 FISH, HER2 ISH, ALK FISH) in which the hybridization is performed at Lab B (off-site laboratory).
How to Treat a Patient Sample
Lab A sends the sample for hybridization to Lab B. Lab A reviews and reports the interpretation results as the laboratory normally would.
How to Treat a PT Sample
FLaboratories that interpret and report the results of ISH testing (eg, HER2 FISH, HER2 ISH, ALK FISH), in which the hybridization is performed at an outside laboratory, should not enroll in proficiency testing for that assay due to prohibitions on proficiency testing referral by CMS (per CMS hybridization is considered a test); such laboratories must perform alternative assessment at least semi-annually.

Scenario Seven
A laboratory technician ordered all PT kits under the main laboratory CAP/CLIA number for the whole system. PT samples were delivered to satellite laboratories with unique CAP/CLIA numbers. The results were collected and reported by the laboratory technician from the main laboratory.
How to Treat a Patient Sample
Patient samples/slides may be distributed throughout the system for testing. Patient reports must define where the result/diagnosis was rendered.
How to Treat a PT Sample
Delivering PT samples to satellite laboratories and reporting all the PT results from the main laboratory is unacceptable and is BOTH PT referral and interlaboratory communication. Each CAP/CLIA laboratory is required to enroll in separate PT.

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