Valerie Neff Newitt
December 2024—The new edition of the CAP accreditation program checklists will contain revised requirements for the qualification of laboratory directors, technical and general supervisors, technical and clinical consultants, and moderate- and high-complexity testing personnel.
All changes stem from the Centers for Medicare and Medicaid Services’ final rule issued one year ago on CLIA fees, histocompatibility, personnel, and alternative sanctions for certificate of waiver laboratories (CMS-3326-F). Provisions related to fees and alternative sanctions took effect earlier this year, with no effect on CAP checklist requirements.
But the rule’s personnel and histocompatibility provisions required that the CAP checklists be revised to align with the final rule, given the CAP’s deeming authority as an accrediting organization under CLIA. And they go into effect on Dec. 28, 2024.
“The important thing is that people who hold an affected position before the changes will be able to continue in that position regardless of whether they meet the new requirements,” says Richard Scanlan, MD, former chair of the CAP Council on Accreditation and professor of pathology, Oregon Health and Science University. “The problem is not with laboratories’ existing staffing, but when they fill this position with a new person in 2025 and beyond, they need to pay attention to these new requirements to make sure that individual is qualified to take the position.”
The CAP will soon provide to inspectors and laboratories a personnel guidance document that details the required qualifications for each laboratory role. It will simplify the new requirements, says Stephen Sarewitz, MD, chair of the CAP Checklists Committee. “You will be able to wade through these complexities in a way that’s understandable,” he says.
“There are multiple ways that an individual can qualify for various positions in the laboratory, and the guide will make it clear whether an individual is qualified or not.” (It will be available online at www.cap.org in the e-Lab Solutions Suite.)
At CAP TODAY’s deadline in late November, the new checklists and the personnel guidance document were awaiting CMS approval. Their release will follow approval.
One of the revised requirements in the new checklist edition is DRA.10100 Laboratory Director Qualifications, which says the laboratory director must satisfy the CAP’s personnel requirements.
“The most consequential change is if you are going to be a laboratory director through the pathologist track, you must be board certified as opposed to board eligible,” Dr. Sarewitz says. “The requirement no longer allows an equivalence to board certification.”
Also new in the requirement is a provision that applies to nonpathologist laboratory directors in laboratories performing high- and moderate-complexity testing. It requires at least 20 CE credit hours in laboratory practice that cover the director responsibilities defined in the DRA checklist. “It’s a little clearer now the kind of continuing education credit that would qualify for that requirement,” says Gregory Gagnon, MD, a member of the CAP Checklists Committee.
If a pathologist is not board certified, they would need to qualify as a nonpathologist physician, with the documented two years of experience supervising high-complexity testing and the 20 CE hours in lab director responsibilities. For moderate-complexity testing, the requirement is the 20 CE hours and at least one year of experience supervising nonwaived lab testing.
A provision in DRA.10100 says the requirements for CE do not apply to existing laboratory directors who were serving in their role as of Dec. 28, 2024 and who remain continuously employed in that role since Dec. 28.
The changes are “in terms of going forward,” Dr. Sarewitz says.
The same is true of DRA.10150 Provision of Anatomic Pathology Services, which requires that anatomic pathology services be provided by a pathologist certified in AP but says pathologists who qualified to provide these services before Dec. 28 may continue to provide them if they have done so continuously in a CLIA-certified laboratory. With board exams often taken months after pathology training has been completed, “This [DRA.10150] potentially could be a problem in the field,” Dr. Sarewitz acknowledges.
DRA.10432 Director On-Site Visits—Laboratories Subject to US Regulations requires the on-site visits to take place at least every six months, with at least four months between the two visits. Previously, the requirement was less explicit, saying the frequency had to be appropriate and acceptable to the laboratory, among others. “Now it’s cut and dry,” Dr. Sarewitz says. If a laboratory has multiple sites under the same CLIA number, the director does not have to visit every site with each visit, he says, adding, “They could visit one location per visit.” DRA.10433 for laboratories not subject to U.S. regulations now requires yearly visits.
In the laboratory general checklist, GEN.53400 Section Director/Technical Supervisor Qualifications/Responsibilities says the personnel in these roles in labs that perform high-complexity testing must meet defined qualifications for the specialties supervised and fulfill the expected responsibilities.
Here, too, the requirement says those who qualify and serve as a technical supervisor for high-complexity testing in a CLIA-certified lab as of Dec. 28 and continuously since that date can continue to fill this role.
In transfusion medicine, the CLIA final rule relaxed the requirement, allowing an immunohematology technical supervisor to have a master’s or bachelor’s degree with the appropriate amount of experience. The CAP, however, will maintain a more stringent standard than the CMS requires. TRM.50050 Transfusion Service Medical Director (Technical Supervisor) Qualifications requires the transfusion service medical director (technical supervisor) to be a physician. “The reason is there are functions the director of transfusion medicine must perform, such as the interpretation of transfusion reaction studies and overseeing apheresis and donor services, therapeutic phlebotomy, and deviations from standard operating procedures, which require medical judgment,” Dr. Sarewitz explains.
The 2024 checklist edition will now permit immunohematology technical supervisor functions allowed under CLIA that don’t require medical judgment—overseeing quality control and resolving technical problems, for example—to be delegated by the physician to a technical supervisor qualifying under the less stringent immunohematology technical supervisor regulation 42 CFR §493.1449(d).
TRM.42050 Transfusion Reaction Interpretation says the transfusion service medical director “or physician designee” interprets and reports the findings of an adverse reaction investigation in a timely and effective manner. “Specifying it must be done by a physician wasn’t necessary previously because the technical supervisors had to be physicians. Now under CLIA,” Dr. Sarewitz says, “they don’t have to be. So the CAP wants it to be clear what can be delegated to a nonphysician and what cannot.”
In histocompatibility, HSC.40000 spells out the section director/technical supervisor qualifications, which Dr. Scanlan sums up in part this way: “PhDs must have the right PhD and the right experience.” The training and experience must relate to the testing of human specimens for the purpose of diagnosing, treating, and monitoring a person’s condition, says Dr. Gagnon. “The best way to document this in a lab would be to identify the lab in which the training occurred by name or by CLIA number or both.”
For MDs and DOs, Dr. Scanlan continues his summary of the requirement, “just because you’re a good doctor doesn’t mean you qualify. You must have on-the-job experience.”
GEN.53600 General Supervisor Qualifications/Responsibilities details the required qualifications but also contains an update to the CLIA regulation as it relates to those who are qualified to carry out the competency assessment of personnel who perform testing in moderate- and high-complexity laboratories. Pre-final rule, “The general supervisor was allowed to do the competency assessments for individuals doing the high-complexity testing,” Dr. Sarewitz says, “but the general supervisor was not allowed to do assessments for people doing moderate-complexity testing. It was anomalous.” The problem, he says, was that the requirements for the technical consultant in the moderate-complexity lab were more stringent than for general supervisors of high-complexity labs. Now, in a laboratory that does both moderate- and high-complexity testing, he says, a general supervisor can do assessments for both types of testing.
Thus, two CAP requirements have been revised to allow for a general supervisor or person who meets those qualifications to assess competency for both moderate- and high-complexity testing (GEN.55510 and POC.06920 Competency Assessment—Assessor Qualifications).
GEN.53625 Technical Consultant Qualifications/Responsibilities now allows for a person with an associate’s degree in medical laboratory technology, medical laboratory science, or clinical laboratory science with at least four years of training and/or experience in nonwaived testing. “In the past,” Dr. Gagnon says, “associate-degree-prepared medical technologists could not be designated as technical consultants. Now, with at least four years of training or experience, they can. That’s important because technical consultants can do competency assessments for moderate-complexity testing. This opens a large number of individuals in the lab who can be delegated to do some of these supervisory tasks.”
The same checklist requirement now permits qualification for someone with a bachelor’s degree in respiratory therapy or cardiovascular technology to be a technical consultant for moderate-complexity blood gas analysis, provided the person has at least two years of education and/or experience in blood gas analysis.
GEN.53650 Clinical Consultant Qualifications/Responsibilities is revised in that it now explicitly requires doctoral scientists and nonpathologist physicians to qualify with at least 20 CE credit hours in laboratory practice that cover the director responsibilities and, for high-complexity testing, at least two years of training or experience or both in supervising such work. For moderate-complexity testing, the requirement is the 20 CE hours and one year of experience directing or supervising nonwaived testing.
GEN.54750 Nonwaived Testing Personnel Qualifications sets forth all the relevant requirements, with a new pathway for blood gas testing only (moderate complexity): a bachelor’s degree in respiratory therapy or cardiovascular technology, with at least one year of lab training or experience or both in blood gas analysis, or an associate’s degree related to pulmonary function, with at least two years of training, experience, or both, in blood gas analysis.
“CMS’ rationale in this case was that when the regulations were originally published, most blood gas testing was high complexity, but with the advances of technology now, some of the testing devices have become simpler to use and have been classified as moderate-complexity testing,” Dr. Sarewitz says. The CMS therefore decided to include degree qualification options that better match the qualifications of those who perform the testing.
In provider-performed microscopy and limited waived testing, the point-of-care checklist says the requirements apply to testing that is performed by a physician or mid-level practitioner and details who those practitioners are: physician assistant, nurse practitioner, nurse midwife, nurse anesthetist, or clinical nurse specialist. The latter two categories are new additions. “Just to be more explicit in terms of the types of individuals who would do this type of testing,” Dr. Sarewitz says.
For all personnel roles, physical science has been removed from requirements as a qualifying degree.
“Physical science encompassed too many different types of training that might not be relevant to laboratory medicine,” Dr. Sarewitz explains.
Many of the changes provide more avenues for qualification, not fewer, he says, and it’s mainly the requirement for the pathologist to be certified and the removal of the physical science degree that make the requirements more stringent.
For personnel hired after Dec. 28, 2024, the laboratory should evaluate the educational background, training, and experience for each individual in the lab and determine which of the CLIA roles that person has the qualifications for, per the updated CLIA requirements and using the checklists and the CAP personnel guidance document, Dr. Gagnon says. Once that is known, he says, “It becomes fairly straightforward what sort of responsibility you can delegate to that person moving forward.”
After “the highest CLIA role they qualify for” is determined, he continues, gather all the education, training, and experience documentation in a file. For example, for experience in a specialty/discipline, there needs to be an attestation or record of some kind that says, “This individual did this work in the blood bank, for example, for five years at this other lab.” These documents should be part of personnel files already, Dr. Gagnon notes, but such files are more complete in some labs than in others. “Some labs rely on human resources departments to maintain that documentation, and if I am an inspector, I have to go to a human resources individual, and it may not be the kind of documentation that would convince me that they’ve met the qualification.”
The CAP personnel guidance document will clarify who must meet what qualification and how, Dr. Scanlan says. “These regulations are complicated, and we couldn’t efficiently spell out the detail needed in the checklists to make it crystal clear, so we created the document that lives on the side and we highly recommend people use it.”
Even more clarity might come in the form of a proposed artificial intelligence solution, he says, if the proposal is approved for development. “It would qualify individuals by electronic analysis of their paperwork,” he says, adding, “It’s still just aspirational” and development time would not be short.
In the meantime, Dr. Scanlan says, laboratories have a few more complications to contend with. “It’s a road, and there are a few more potholes in the road that you have to be careful with.”
Valerie Neff Newitt is a writer in Audubon, Pa.
In addition to the CAP personnel guidance document that will become available after the new checklist edition is published, another resource available to CAP-accredited laboratories at www.cap.org in e-Lab Solutions Suite (under Accreditation Resources-Templates) are templates that can help them document the evaluation of personnel qualifications for various roles and perform transcript review for degrees that require further evaluation.
A CAP Focus on Compliance webinar will take place Feb. 19. Titled “Personnel Essentials: A Deep Dive Into Personnel Roles and Qualifications,” it will focus on updates relating to the CLIA final rule changes, templates and tipsheets and other available resources, and how to evaluate transcripts. Enroll at www.cap.org (Laboratory Improvement → Accreditation → Educational Resources).