CMS-Approved Proficiency Testing Programs

CMS's document lists each program under its address and phone, then the subspecialty headings it is approved for, then the analytes under each heading. The plate above shows the headings only. The analyte lists differ: under general immunology, INSTAND is listed for IgE alone, while AAB-MLE lists a long run from alpha-fetoprotein to rubella. Before you count on a program for one test, find that analyte under the program's name in the CMS document.

A blank well means the heading does not appear under that program on CMS's list. It says nothing about what the program sells as education or for unregulated tests; it only means CMS has not listed the program for that subspecialty, so another program has to cover it.

Cytology PT is not on the plate above. It is its own requirement under § 493.855(a), and it covers people as well as the lab: per CMS's PT requirements page, the laboratory and the personnel who examine gynecologic cytology slides must be enrolled in a CMS-approved cytology PT program. CMS names two: the College of American Pathologists (CAP) and the American Society for Clinical Pathology (ASCP).

Under § 493.801, a lab must enroll in an approved program for each specialty and subspecialty it seeks certification for, tell HHS which program it uses, and, if it uses more than one, designate which program counts for each specialty, subspecialty and analyte. Mixing programs is allowed; the plate shows where that is the only way to cover a menu. Enrollment sits alongside getting a CLIA certificate.

• Switching waits a year. The lab stays in a chosen program for an analyte "for one year before designating a different program and must notify CMS" before the change (§ 493.801(a)(3)).
• Samples are patient specimens. PT samples are tested "in the same manner as patient specimens" (§ 493.801(b)) and, as CMS's PT page puts it, can't be referred to another laboratory for analysis.
• The schedule is fixed by rule. For a regulated analyte a program sends "a minimum of five samples per testing event" with "at least three testing events at approximately equal intervals per year" (routine chemistry, § 493.931(a)).
• CMS sees the scores. The program reports results and scores to CMS "within 60 days after the date by which the laboratory must report" (§ 493.903(a)(1)). An accredited lab also authorizes its program to send results to its accreditor (§ 493.551(b)(4)). To check an event before the program's report arrives, score a PT event with the calculator; the rules behind the scores are in how CLIA proficiency testing works.

For how the four broad programs differ on shipping calendar, result entry and ungraded results, see CAP vs API proficiency testing. If you are choosing an accreditor at the same time, the CMS-approved accreditation organizations list sets out which specialties each one may accredit.