According to CLIA, a protocol must list the specific types of specimens that non-pathologists are permitted to gross and for which non-pathologists are permitted to assist in the gross examination. The laboratory director must develop:
a. protocols with a list of specific types of specimens that non-pathologists are permitted to gross;
b. a protocol of training;
c. a protocol of supervision and periodic review; and
d. the laboratory inspection proof.
According to CLIA, "the technical supervisor may delegate to individuals who qualify under §493.1489 the responsibility for physical examination/description, including color, weight, measurement and other characteristics of the tissue; or other mechanical procedures for which a specific written protocol has been developed."5
CLIA also provides options for individuals qualified under §493.1489. The minimum training/experience required of such personnel is:
1. an earned associate degree in a laboratory science or medical laboratory technology,obtained from an accredited institution, or
2. education/training equivalent to the above that includes at least 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 or medical laboratory technology in any combination and three months of documented training in the field in which the individual perform high complexity testing.
CLIA regulations also include exceptions for "grandfathered" individuals (before April 24, 1995). Most people entering the grossing working force already have these credentials in different ways. Credit hours in chemistry and biology, as well as in medical laboratory, however, cannot substitute any knowledge of pathology that is in the background of surgical pathology grossing practice.
All regulations related to non-pathologists exclude pathology residents who presumably work under direct supervision of pathologists. Pathologists' assistants, as fellows of American Association of Pathologists' Assistants (AAPA) with ASCP certification, meet all regulatory requirements automatically.
Many institutions develop some formal protection by carefully maintained documentation to be in compliance. For example, if a laboratory processes only biopsies, the management can hire a person who meets CLIA educational requirements and develop an in-house 15-18 week training program with post training tests. More advanced programs develop phases of training (usually three) with increasing of complexity of the specimens (e.g., starting with biopsies and widening the scope of specimens to gall bladders, placentas and other so-called routine specimens).
After progressing to the final phase, training is completed with medical director review of 100% cases at random monthly intervals. Discrepancies are documented.
Dr. Dimenstein has retired from the Pathology Department, Loyola University Chicago Medical Center. He runs a website on the topics in this article and more at www.grossing-technology.com.
1. Association of Directors of Anatomic and Surgical Pathology: Recommendations for Quality Assurance and Improvement in Surgical and Autopsy Pathology. Am J Surg Pathol 30: 1469-1471, 2006.
2. Histo-Logic Vol. XXX. Number 1:20, 1999.
3. In Action NSH Newsletter. Vol. 36, Number 4: 2-3, 2009.
4. Commission on Laboratory Accreditation Inspection. Laboratory Accreditation Programs Checklist: Anatomic Pathology, Section 8. College of American Pathologists, Northfield, IL, 2006.
5. http://www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf.%20Interpretive%20Guidlines%20Section%20493.1489 (b) (7). Accessed February 8, 2009.