Question.

What is considered Grossing according to CLIA and CAP? Definition?

Per the grossing definition in ANP.11610 below, grossing is defined as a tissue examination requiring judgment and knowledge of anatomy. This includes the dissection of the specimen, selection of tissue, and any level of examination/description of the tissue including color, weight, measurement or other characteristics of the tissue. CLIA Regulation 42 CFR Part 493.1489 would apply for high complexity testing personnel qualifications.

CAP regulations:

ANP.11600 Gross Examination - Qualifications All macroscopic tissue gross examinations are performed by a qualified pathologist or pathology resident, or another qualified physician (see note), or under the supervision of a qualified pathologist.

ANP.11605 Gross Examination - Non-Pathologist When individuals other than a pathologist or pathology resident assist in gross examinations, the extent of their activities and the nature of supervision (direct vs. indirect) is defined in a written protocol.

ANP.11610 Gross Examination - High Complexity Testing Qualifications If individuals other than a pathologist or pathology resident (or an individual who meets the grossing subspecialty qualifications listed under ANP.11600) assist in gross examinations, such individuals qualify as high complexity testing personnel.

NOTE: Grossing is defined as a tissue examination requiring judgment and knowledge of anatomy. This includes the dissection of the specimen, selection of tissue, and any level of examination/description of the tissue including color, weight, measurement or other characteristics of the tissue. The laboratory director may delegate the dissection of specimens to non-pathologist individuals; these individuals must be qualified as high complexity testing personnel under the CLIA regulations. The minimum training/experience required of such personnel is:

1. An earned associate degree in a chemical or biological science or medical laboratory technology, obtained from an accredited institution, OR

2. Education/training equivalent to the above that includes the following:

60 semester hours or equivalent from an accredited institution. This education must include 24 semester hours of medical laboratory technology courses, OR 24 semester hours of science courses that includes six semester hours of chemistry, six semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination, AND

Laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLS, or other organization approved by HHS (note that this training may be included in the 60 semester hours listed above), OR at least three months of recorded laboratory training in each specialty in which the individual performs high complexity testing.

Jennifer Wooten, BA, BS, HTL (ASCP)CM

Pronouns: she/her/hers

Technical Quality Assurance Auditor | Quality Systems | Tricore