Originally published in CAP TODAY
Q. I direct several small laboratories that are remote from each other. I have established a policy for hematology specimens that if an immature cell is encountered in a patient specimen, the specimen be referred to me for final diagnosis. In such an event, we include on the report the name and CLIA number of the laboratory at which the final diagnosis was made. What should we do when a proficiency testing challenge includes a specimen with immature cells?
A. The best quality practices in pathology and laboratory medicine may not parallel the procedures that are allowed in proficiency testing.
The Laboratory Accreditation Program requires that any body fluid with suspected malignant cells be reviewed by "a pathologist or other qualified physician" (HEM.35585, phase II). The checklist also requires laboratories to have "documented criteria with specified findings for blood films that must be reviewed by the pathologist, supervisor or other technologist qualified in hematomorphology..." (HEM. 34600, phase II).
CLIA '88 regulations for proficiency testing prohibit an institution from referring a PT sample to an outside laboratory. According to CLIA, a pathologist who is affiliated with multiple laboratories is considered to be part of the laboratory where he or she is physically located at that moment.
If the pathologist is on-site, it is acceptable for the laboratory to submit the PT specimen to him or her for review if, and only if, that is the institution's standard procedure for patient specimens. If, however, the pathologist is at one of the other laboratories, the Centers for Medicare and Medicaid Services has indicated that the specimen may not be submitted to the pathologist at the other site because that would violate the regulatory prohibition against referring specimens to an outside laboratory. The laboratory would have to report the PT result as "unable to analyze."
The lab can send the specimen to the pathologist for interpretation for educational purposes once the due date for the PT challenge has passed, but the pathologist's diagnosis cannot be reported as a PT result. Thus, for a pathologist to review PT specimens at more than one laboratory, he or she must travel to each site to perform the review or face the possibility of exposing the laboratory and the lab director to serious punitive consequences.
A considerable amount of confusion has surrounded this issue. CMS stands by its decision to handle PT specimens in a different manner than patient specimens. This is an unfortunate situation in which regulations seem inconsistent with education and the promotion of quality laboratory practice.
The Commission on Laboratory Accreditation continually revises the CAP checklists to keep checklist content state-of-the-art in laboratory medicine and make the checklists as user-friendly and easy to interpret as possible. The commission welcomes input from laboratories and inspectors regarding potential improvements to the checklists. E-mail suggested checklist changes to email@example.com.