Part 1 of this 2-part article explores regulatory requirements.
No one doubts who signs out the surgical pathology report or who does microtomy and slide staining. When it comes to who does grossing, especially biopsies and small specimens, however, the clarity gets blurred. There is no uniformity in assignment of this work in academic institutions vs. community hospitals, not to mention commercial laboratories. Even in similar institutions the assignment of grossing is different.
Everyone agrees on grossing importance for diagnostic outcome of the case, but grossing is discussed rarely in earnest. Just as an indirect example, Recommendations for Quality Assurance and Improvement in Surgical and Autopsy Pathology by Association of Directors of Anatomic and Surgical Pathology, while presenting the detailed roster of accession and histology monitors for errors prevention, failed to mention grossing issues.1
This article explores the assignment of grossing biopsies and small specimens in surgical pathology practice.
Who Does What?
Who does the biopsies and small specimens grossing? The answer to this question depends on the institution, concrete participants and sometimes cases. For example, although every pathology report includes gross description, it is an aberration if a pathologist does grossing on a regular basis in most laboratories, especially biopsies and small specimens. In academic institutions, grossing is assigned to pathology residents. In institutions with pathologists’ assistants and grossing histotechnologists, first year residents start with large specimens and finish the grossing training with biopsies and small specimens on weekends or as emergency substitutes. Residents have many educational sessions, exams and other concurrent responsibilities that may interfere with the interests of the laboratory workflow. For the laboratory, it may be better to excuse them from grossing biopsies only to the limits of their training interests.
Pathologists’ assistants perform grossing, including biopsies and small specimens, in institutions that have them on staff. Pathologists’ assistants who graduated from special programs at the level of bachelor’s or master degrees have a sufficient level of education for this task. American Association of Pathologists’ Assistants (AAPA) introduced American Society for Clinical Pathology (ASCP) certification.
So while others can perform grossing biopsies, the tendency is to delegate it to histotechnologists. And this discipline includes two positions: histotechnicians (HT) and histotechnologists (HTL). HTL(ASCP) certification requires a bachelor degree and knowledge of immunohistochemistry (IHC), although many HT successfully work in immunohistochemistry.
In 1999, the National Society for Histotechnology (NSH) Board of Directors noticed that “many laboratories are expecting histology technicians to ‘gross-in’ small specimens,”2 which became one of the reasons to require AA degree or 60 semester hours of college for HT(ASCP) certification after 2005. To date, no task force has been established to work on grossing issues.3 Grossing topics generate an explosion on postings at HistoNet discussion group, especially the question of eligibility for doing grossing by histology technicians.
CAP is the main regulatory body that determines accreditation requirements in surgical pathology. CLIA ’88 provides the governmental regulation of laboratories’ performance. Compliance with the latter is obligatory. Other accreditation agencies, such as the Joint Commission, are neutral to grossing compliance issues.
The CAP accreditation checklist formerly included a set of questions ANP 11600-11670 about grossing.4 Three main checklist’s questions include:
- Are all macroscopic tissue examinations performed by a pathologist or pathology resident, or under the supervision of a qualified pathologist?
- When an individual other than a pathologist or pathology resident processes a specimen, or assists in grossing examination, is the extent of their activities (including the types of specimens examined) defined in a documented protocol?
- Is the performance of non-pathologists who perform gross tissue examinations evaluated by the pathologist on a regular, periodic basis?
Traditionally, CAP distinguished processing (taking measurements and putting biopsies in the cassette with no cutting involved) and grossing (anything that must be cut in) and divides surgical pathology specimens in first and second class. CLIA, on the other hand, considers all grossing to be high complexity testing. However, CAP recently announced a revision to their accreditation checklist eliminating the concept of processing of tissues. The soon-to-be-released revised CAP checklist will no longer separate the activities of grossing and processing, and the standard for personnel performing this work will be the same as those given in CLIA. If a laboratory is in compliance with CLIA, it automatically meets CAP’s requirements.
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:
- protocols with a list of specific types of specimens that non-pathologists are permitted to gross;
- a protocol of training;
- a protocol of supervision and periodic review; and
- 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:
- an earned associate degree in a laboratory science or medical laboratory technology,obtained from an accredited institution, or
- 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.
- 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.
- Histo-Logic Vol. XXX. Number 1:20, 1999.
- In Action NSH Newsletter. Vol. 36, Number 4: 2-3, 2009.
- Commission on Laboratory Accreditation Inspection. Laboratory Accreditation Programs Checklist: Anatomic Pathology, Section 8. College of American Pathologists, Northfield, IL, 2006.
- http://www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf.%20Interpretive%20Guidlines%20Section%20493.1489(b) (7). Accessed February 8, 2009.