No one doubts who signs out the surgical pathology report (a pathologist), as well as who does microtomy and slide staining (a histotechnologist). When it comes to who does grossing, especially biopsies and small specimens, the clarity becomes 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 the importance of grossing 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 at all (1). The endless discussions, for example on the HistoNet, are about eligibility, but the problem is in capability to perform grossing at the appropriate level.
These materials are an attempt to explore the assignment of grossing biopsies and small specimens in surgical pathology practice. This subject is completely ignored in literature. Pragmatic proposals have been made to shift from ambiguity in selecting personnel for grossing these specimens, the bulk of the work load in the surgical pathology laboratory.
Who does the biopsies and small specimens grossing?
It depends on institution, concrete participants, and sometimes on particular cases.
Pathologists. Although every pathology report includes gross description, it is an aberration if a pathologist does grossing on a regular basis in the most laboratories, especially in the case of biopsies and small specimens. This practice is gone with the overwhelming amount of biopsies that makes it physically impossible and in most instances unnecessary.
Pathology residents. In academic institution, grossing is assigned to pathology residents, but there are many variations how it is carried out in practice. In institutions with pathologists’ assistants and grossing histotechnologists, first year residents start with large specimens and finish the grossing training with them doing biopsies and small specimens on weekends or as emergency substitutes. They do grossing work with reluctance, especially biopsies. Grossing is not helpful in their nearest goal such as to pass the Board. This work is a time consuming burden. Residents have many educational sessions, exams and other concurrent responsibilities which interfere with the interests of the workflow. As far as biopsies grossing is concerned, residents’ participation is often an impediment for workflow in the modern histology laboratory with the turn around time (TAT) pressure. For the laboratory, it is better to excuse them from grossing biopsies by limiting only to their training interests.
Pathologists’ assistants. They are called usually PAs. This group is often confused with pathology assistants (see below). Pathologists’ assistants perform grossing, including biopsies and small specimens, in the institutions which have them on the staff. Pathologists’ assistants, who graduated from special programs at the level of bachelors or master degrees, have a completely sufficient level of education for this task. American Association of Pathologists’ Assistants (AAPA) introduced American Society for Clinical Pathology (ASCP) certification. However, here is a catch. For many highly educated pathologists’ assistants grossing biopsies is boring small fry. There is some truth in it because they can do many things in pathology, like physician assistants, another PA group. This brings to the tendency of delegating grossing biopsies to histotechnologist.
Histotechnologists, or histology technicians, or in common use histotechs, include two histology laboratory positions: Histotechnicians (HT) and Histotechnologists (HTL). The difference between them, in general, is insignificant for practice. HTL (ASCP) certification requires bachelor degree and knowledge of immunohistochemistry (IHC), although many HT successfully work in immunohistochemistry.
Nobody can give even an approximate number of histology technicians who do grossing. The 2009 ASCP Board of Certification survey did not include the question about grossing by HT and HTL at all.
In 1999, the National Society for Histotechnology (NSH) Board of Directors noticed that “many laboratories are expecting histology technicians to “gross-in” small specimens” (7). This was one of the reasons to require AA degree or 60 semester hours of college for HT (ASCP) certification after 2005. So far, NSH has not established any of task forces to work on grossing issues (8). Remarkably, the “Histotechnology: A Self-Instruction Textbook”, the most popular among histotechnologists manual for ASCP certification exam, does not include a grossing technique section, although cytology preparation section has been added in the latest 2009 edition (4).
Grossing histology technicians are disguised for many reasons in different names which they share with the “others” group.
Others. The “others” group is heterogeneous. They are called usually in the laboratory also as PAs, but this is very much confusing. This group includes grossing technologists, pathology assistants, and pathologist assistants. Pathology assistants and pathologist assistants should be differentiated from pathologists’ assistants, mentioned above group represented by AAPA. Even managers often confuse these groups unintentionally or with a purpose. Pathology assistant is a support personnel position or a morgue attendant.
Another group, laboratory assistants receive special training in the laboratory to do non-complex tasks like take care of stainers or coverslippers, changing reagents in the tissue processors, recycling, and other technical laboratory assignments. However, some laboratories employ laboratory assistants for grossing biopsies, GI for instance. Sometimes these workers are called gross prosectors. Some laboratories try to achieve cost reduction the gross room under the guise of cross-training (9).
Perhaps, a personal encounter might illustrate the pathology assistant’s employment for grossing biopsies and small specimens. A morgue attendant with a mortician school background moonlighted for grossing biopsies and small specimens (the large did pathology residents) in an academic institution. He replied to my question why he was hired for a grossing job: “I have a tissue touch.” He worked late in the evenings, with a “close pathologist’s supervision,” of course.
Ambiguity and mosaic of positions and responsibilities in grossing biopsies and small specimens were caused by the collision of the tendency to save money on wages and the accreditation regulatory requirements for grossing by non-pathologists. Let’s take a closer look at the regulations.
Regulatory requirements for grossing by non-pathologists
Collegeof American Pathologists(CAP) is the main regulatory body which determines accreditation requirements in surgical pathology. Clinical Laboratory Improvement Act’88 (CLIA) provides the governmental regulation of the laboratories performance. Compliance with the latter is obligatory. Other accreditation agencies, Joint Accreditation Commission for Healthcare Organizations (JACHO), for instance, are neutral to grossing compliance issues. When the CLIA is a remote script, the CAP’s accreditation with it self-inspection provision and on site inspection is the everyday reality with permanent head ache and periodical fever. Every laboratory is interested to maintain the CLIA license and the CAP certification. Would institution’s administration forgive the laboratory/department management failure to get them? The answer is obvious.
The CAP accreditation’s checklist includes a set of questions ANP 11600-11670 about grossing (5). There are three main checklist’s questions:
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 process specimen, or assist 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?
CAP distinguishes processing (taking measurements and putting biopsies in the cassette with not cutting involved) and grossing (anything that must be cut in), dividing surgical pathology specimens in first and second class. CLIA is more stringent and definite. CLIA considers all grossing to be “high complexity testing”. It does not make any sense to analyze CAP’s confusing wording. Processing has a complete different connotation in histology laboratory. Especially CAP changed some of them in the document which will be distributed to laboratories in June 2010. Actually CAP’s changes are insufficient, too late and too little. There is a necessity to change the approach to grossing biopsies and small specimens in the surgical pathology grossing room.
The good news is that if a laboratory were in compliance with CLIA, it automatically meets CAP’s requirements. Technically you can be in compliance with CAP’s standards while being in violation of CLIA requirements. If the lab does any billing with the government (Medicare, Medicaid, etc), it is safer to meet CLIA 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.
If the laboratory director develops
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;
the laboratory is inspection proof.
Who are the non-pathologists permitted to gross examination?
According to CLIA “the technical supervisor may delegate to individuals qualifies 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” (10).
CLIA provides also some 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 6 semester hours of chemistry, 6 semester hours of biology or medical laboratory technology in any combination, as well as 3 months of documented training in the field in which the individual perform high complexity testing.
In addition, the CLIA regulations include exceptions for “grandfathered” individuals (before April 24, 1995). The reality and good new is that most people entering the grossing working force already have these credentials in different ways. The bad news is that credit hours in chemistry and biology, as well as in medical laboratory 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. Now this certification is defined as (ASCP)CM.
Many institutions developed some formal protection by carefully maintained documentation, just to be in compliance. The above mentioned requirements provide some options.
For example, if a laboratory processes only biopsies, the management can hire a person who meets CLIA educational requirements, develop an in- house 15-18 weeks training program with post training tests. The procedures for grossing are specified in written with following documented supervision.
More advanced programs develop phases of training (usually three) with increasing of complexity of the specimens. For example, starting with biopsies and then widening the scope of specimens (gall bladders, placentas and other so-called routine specimens).
After progressing to Phase Three, training is completed with medical director review 100% cases at random monthly intervals. Any discrepancies are documented.
There are more complicated training and supervision programs in large commercial laboratories. Careful documentation, which is solely object of the inspection’s attention, at least reflects the management’s intention and proof that it takes the quality of grossing seriously. I have never seen any inspection at the grossing place though it does not mean that my experience can be generalized.
Some managerial efforts to meet regulation requirements in surgical pathology grossing are directed to on-the job-trained (OJT) workers. This group deserves a closer look.
On- the Job- Training (OJT)
Can be on-the job- training (OJT) definition applied to a nurse, LPN or RN? The question sounds laughable.
On- the job- training is a remnant of good old days when pathologists grossed by themselves assisted by histotechnicians. Actually, histotechnicans were recruited from laboratory or morgue aids or just “from the street.” Many of them became proficient in the artisan histotechnology and in grossing assistance as well. By the way, employment of OJT histology technicians with or without certification is at the discretion of local management without any regulation. ASCP certification is used sometimes only to justify an increase in histology technicians’ wages. Some states, like Florida or New York, require histotech licensing as mandatory.
Times have changed. Many histotechnology programs, though now shrinking and insufficient for the laboratories demand, produce cohorts of educated systematically histology technicians. The old timers were grandfathered. They will eventually leave the professional scene. However, now OJT histology technicians are entering also the histology laboratory working force. This question is presented in detail by René J. Buesa in comprehensive articles about histology laboratories staffing (2, 3).
Pathologists’ assistants also included an OJT group. AAPA does not maintain this route for ASCP certification, probably because it does not have means to check the quality of on the job training . Everything remained at the discretion of local surgical pathology management who signed the appropriate documentation for eligibility to sit on the certification exam. Perhaps, there are other reasons as well.
Sometimes, OJT is a name for grossing justification by trained pathologists who do not have USA license. They need only adjustment of their training to different conditions in the practice. In rare occasions, pathology residents, who haven’t passed the Board exam, work at the grossing positions.
The entire concept of on- the job –training without a theoretical background is questionable as far as grossing in surgical pathology is concerned. It devaluates the seemingly simple grossing procedure. CAP contributed to devaluation of grossing in surgical pathology practice with the confusing separation of processing and grossing.
There are certain grossing techniques which can be taught only at the grossing table, but apprenticeship is not an optimal option to learn grossing. Basic knowledge of surgical pathology is a prerequisite for professional grossing. Only in this situation one can recognize a grossing problem or ask for help to solve it. The less knowledge, the less doubts. The grossing person permanently encounters question about inking (when and how), cutting (when and how), and other numerous situations which can help or hinder the diagnosis making process. The grossing person ought to envision the sample under the pathologist’s microscope. Pathology residents with good tutoring on basic grossing techniques very fast become proficient in grossing owing to their theoretical surgical pathology background.
By the way, it is unfair to deprive people from the joy of understanding what they are doing at work. Only theoretical education can warrant this understanding.
On-the job-training cannot be completely dismissed, but OJT ought to be a very rare exception. In reality, OJT is the rule for histotechnologists.
Grossing Histotechnologist as a Solution
The paper piles, often “Potemkin villages”, conceal the on-the job-training problem in surgical pathology. The current increase of amount and variety of specimens and the detachment of the pathologist and grossing person make the situation first and foremost dangerous for irreplaceable material as biopsies. The grim truth is that pathologists cannot control many grossing outcomes. Pathologists are fully aware of so -called “sampling variations.” By being in denial to recognize the problem, the surgical pathology practice has a swelling abscess on its hands. There is an urgency to find a pragmatic solution for current state of affairs in grossing biopsies and small specimens.
Pathologists’ assistants are the optimal variant. Perhaps, in the future this will be the case, however, now such purist approach would be unrealistic and therefore damaging by maintaining and fueling “under the table” options. Although states with stringent license policies, for example Florida, might try limit grossing only to pathologists, pathology residents, and ASCP certified PA, it is practically unattainable around the country.
There are also parallel problems. Trained pathologists’ assistants are reluctant to work only on biopsies grossing. And managers for plain economical reasons are also reluctant to hire certified pathologists’ assistants for job which do not require, especially in common perception, such “overqualified” workers.
Perhaps, AAPA might develop a certification for “assistant in surgical pathology” and appropriate schools will offer programs for such subspecialty. In principle, it would be reasonable, because some people want to do only surgical pathology grossing without other possible pathologists’ assistant duties, like autopsies. This sounds as an unrealistic wish, but who knows. Now however, I think more and more that this is unrealistic.
The grossing technologist position already exists. In this situation, management establishes this position to maintain the level of a pathologists’ assistants educational and training background without paying their wages. While hiding behind other confusing definitions, managerial compliance tricks are a slippery slope to employment under qualified workers for cheap labor. Just with “a tissue touch,” as I encountered in above told story. Everyone knows what “supervision” means in real surgical pathology practice. It is no more than folders of papers for inspections which do not have methods and desire to proof them.
Grossing histotechnologist would be more appropriate position for a worker who does grossing biopsies and small specimens in surgical pathology. Histotechnologists are the natural pool for this task. Having experience in embedding and microtomy, histotechnologists can visualize and predict the small sample’s “behavior” after grossing to assure that the most diagnostically valuable part of the sample appears on the slide under the pathologist’s microscope. Grossing histotechnologists can be effective in assurance of completeness of submission of the specimen by understanding how it can be lost during processing and microtomy. Grossing technology of biopsies and small specimens is very much different from grossing large specimens though general principles apply to all of them (10). The specimen after the Whipple surgery is, of course, incomparable with a duodenal biopsy, but the latter might be also diagnostically challenging and depending from grossing orientation technique, for example in suspected celiac disease.
Histotechnologists can be interested in pursue grossing as a professional carrier for many reasons. Among them might be the desire to go out from a monotonous physically demanding microtomy work. And, of course, increase in wages can be a substantial incentive. Safety requirements in the gross room are the most stringent in the laboratory, and for good reasons, because the worker encounters many chemical and biohazards. This ought to be also compensated by differences in wages.
There is an experience abroad by involving histotech in grossing, especially in biopsies and small specimens. For example inAustralia, the Royal College of Pathologists has guidelines for biomedical scientists (BMS) who are doing macroscopy (specimen dissection, cut-up, dictation, and block selection). This practice is wide spread in Britain, Canada , and Australia.
Of course, it is not enough only to declare a new position wrapped in a different paper facade. Grossing histotechnologist position can make a difference if it meets certain conditions.
1. Theoretical course in surgical pathology at one of the histotechnology programs. It might be also offered by a pathologists’ assistant program. This is the main requirement.
2. A course of internship as a part of the theoretical course. Otherwise the theoretical background will evaporate very fast in the assemble line production in the modern surgical pathology laboratory.
3. Educational background is optimal at the level of eligibility for HT or HTL ASCP certification. As it was mentioned before, the difference between HT and HTL certification is a requirement of BS degree and knowledge of immunohistochemistry for HTL.
The scope of responsibilities should be limited by grossing biopsies and small specimen with a certain list of them determined by an institution’s policy that actually is in practice of many institutions. The responsibilities should include accession and grossing triage which are significant part of professional specimen processing in the modern surgical pathology laboratory due to the variety of ancillary studies (6).
ASCP certification should be the final stage of training and eligibility for grossing histotechnologists. ASCP has a well established system of certifications. The pathologists’ assistants’ ASCP certification would not be difficult to transform in grossing histotechnologist certification.
Without the involvement of the both major pathology organizations, CAP and ASCP, the establishment of grossing histotechnologist subspecialty is unpractical. National Society for Histotechnology and American Association of Pathologists’ Assistants, as interested organizations, cannot be neutral. Schools of histotechnology and pathologists’ assistant programs which provide them with educated working force can lend support by opening special educational courses.
However, the main thing is to admit that grossing biopsies and small specimens staffing in surgical pathology is not right. Without a call from pathologists and local managers, the establishment of the grossing histotechnologist subspecialty is impossible. Abandoning the denial and acknowledge the grossing histotechs training problem is the first step. Otherwise, as it goes in a joke : “he’s got solutions the rest of us don’t even have problems for.” Everything starts and ends up in the laboratory.
It requires managerial will and efforts of surgical pathology community to break away from ambiguity in assignments of grossing biopsies and small specimens. Grossing histotechnologist subspecialty can be an optimal pragmatic solution in wide range of laboratories. The establishment of this position would provide assurance of processing quality of this irreplaceable and crucial for patient’s diagnosis specimens.
CAP formal requirement for other than a pathologist assistant or pathologist presented below. The policy of many laboratories is to use the histotechnician certification HT(ASCP) or HTL (ASCP) as qualification to gross since there is an educational requirement for certification that is comparable or exceeds the CAP requirement.
**REVISED** 07/11/2011 ANP.11605 Gross Examination – Non-Pathologist Phase II 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 documented protocol. NOTE: This protocol must list the specific types of specimens for which non-pathologists are permitted to assist in the gross examination. The nature of the supervision must be established individually, for each non-pathologist. The laboratory director is responsible for this protocol.
REFERENCES 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7183 [42CFR493.1489(b)(6)] 2) Cibull ML. Q&A. Northfield, IL: College of American Pathologists CAP Today. 1997;11(7):112 3) Grzybicki DM, et al. National practice characteristics and utilization of pathologists’ assistants. Arch Pathol Lab Med. 2001;125:905-912
**REVISED** 07/11/2011 ANP.11610 Gross Examination Qualifications Phase II If individuals other than a pathologist or pathology resident assist in gross examinations, such individuals qualify as high complexity testing personnel under CLIA regulations. NOTE: The laboratory director may delegate the dissection of specimens to non-pathologist individuals; these individuals must be qualified as high complexity testing personnel under CLIA regulations. 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 6 semester hours of chemistry, 6 semester hours of biology, and 12 semester hours of chemistry, biology or medical laboratory technology in any combination. In addition, the individual must have laboratory training including either completion of a clinical laboratory training program approved or accredited by the ABHES, NAACLA, or other organization approved by HHS (note that this training may be included in the 60 semester hours listed above), OR at least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. It is the responsibility of the laboratory director to determine whether an individual’s education, training and experience satisfies the requirements of this checklist requirement. This checklist requirement applies only to laboratories subject to US regulations. Evidence of Compliance: ✓ Records of qualifications including degree or transcript and work history in related field OR documentation of grandfathered exception REFERENCES 1) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Oct 1):1070-1071 [42CFR493.1489], 1071-1072 [42CFR493.1491].
This article was partially published on
Dimenstein IB: “The Grossing Histotechnologist in Surgical Pathology” (Two installments) Advance for Administrators of the Laboratory online edition 2010 May 10th and 20th
For full disclosure, this article was rejected for publication by Americal Journal of Surgical Pathology , as well as by Journal of Histotechnology although it was written specifically for these publications as presumably most interested in the subject.
1. Association of Directors of Anatomic and Surgical Pathology Recommendations for Quality Assurance and Improvement in Surgical and Autopsy Pathology. Am J Surg Pathol. 2006; 30: 1469-1471.
2. Buesa RJ. Salaries in histology. Annals of Diagnostic Pathology. 2008; 12: 122-127.
3. Buesa RJ. Histology aging force and what to do about it. Annals of Diagnostic Pathology. 2009; 13 (3): 176-184.
4.CarsonFLand Hladik Ch Histotechnology: A Self-Instructional Text.Chicago: ASCP Press, 2009.
5. Commission on Laboratory Accreditation Inspection. Laboratory Accreditation Programs Checklist: Anatomic Pathology, Section CollegeofAmericanPathologists,Northfield,IL, 2006.
6. Dimenstein IB. Grossing biopsies: an introduction to general principles and techniques. Annals of Diagnostic Pathology. 2009; 13: 106-113.
7. Histo-Logic. 1999 Vol. XXX. Number 1:20.
8. In Action. NSH Newsletter. 2009, Vol. 36, Number 4: 2-3.
9. Weidner N,CoteRJ, Suster S, et al. Modern Surgical Pathology. Volume 1. Saunders; 2003:3-4.
10. www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf. Interpretive Guidelines Section 493.1489 (b) Accessed December 20, 2009.