Few but notable— new accreditation checklist changes

Those would fall under GEN.43022 LIS Testing, which says computer programs must be checked for proper performance when first installed and after changes or modifications; however, a check every two years is not required. Dr. Sarewitz notes that this requirement does not apply to calculated patient results but instead to reference intervals, critical values and/or verification limits, and operational rules/algorithms.

In the anatomic pathology checklist is a requirement for record and material retention in surgical pathology (ANP.12500), which has been revised in the 2023 edition to include different retention requirements for paraffin blocks for deceased patients to improve the availability of material for research. The CAP requires that paraffin blocks used to support a patient’s diagnosis be retained for 10 years, Dr. Sarewitz says, because often it is several years post-diagnosis when the patient needs additional treatment. The revision in the new checklist edition shortens the retention period for deceased patients from 10 years to two years. If a patient is deceased, only one block containing normal tissue (if it exists) needs to be retained for the full 10-year period. “A germline genetic mutation that might affect other family members” is the reason for retaining the block containing normal tissue, Dr. Sarewitz explains.

The requirement revision, while it may increase the complexity of the documentation that’s required before the blocks are released (documenting the death and distinguishing tumor blocks from normal blocks), has the potential to make more pathologic material available for research purposes.

No changes were made in the block retention requirements for living patients.

In cytopathology, CYP.07600, which requires statistical records for gynecologic cytopathology cases to be maintained and evaluated at least annually, already states that the benchmarking data provided in the requirement may not be applicable to labs that use primary HPV screening for a significant portion of their cervical cancer screening. Additional language in the note will state that in the benchmarking data, which are based on 2021 case volumes, results were excluded for labs that included primary HPV screening results in the interpretive totals when more than 25 percent of their cervical/gynecologic cytology slides were from positive primary HPV screening. “The table is meant to apply to patients who come in for primary cytologic screening but not those who have been reflexed to cytology because of a positive HPV test,” Dr. Sarewitz says. (See “Impact of primary HPV testing on cytology lab statistical analysis,” in Cytopathology in Focus.)

In the histocompatibility checklist, requirement HSC.40000 on section director/technical supervisor qualifications contains changes for laboratories whether or not they participate as members of the Organ Procurement and Transplantation Network (OPTN) or United Network for Organ Sharing (UNOS). This is part of a new process that the CAP will implement to evaluate changes in HLA section directors (technical supervisors). “If a new person becomes the HLA section director,” Dr. Sarewitz says, “the laboratory must submit information to the CAP on the qualifications of the new section director, whether or not the laboratory participates in the United Network for Organ Sharing/Organ Procurement and Transplantation Network.”

For laboratories that participate as members of OPTN/UNOS, part of the information requested may include a portfolio from the new director of 50 cases of transplantation (10 in detail and a log of 50 total) to cover the programs they support (solid organ transplantation, hematopoietic progenitor cell transplantation, or transfusion support), and several additional items, he says, among them proof of active interaction with transplant professionals and a statement of experience. Submission of the portfolio may not be required if the laboratory can provide evidence that the portfolio has been reviewed and approved by a certifying board such as the American College of Histocompatibility and Immunogenetics or similar agency.

For laboratories that do not participate as members of OPTN/UNOS, when a new section director was brought on, the prior checklist edition required that the director provide a portfolio of 10 cases to be examined by the inspector during the inspection. The 2023 edition will require that information on the qualifications of the section director be submitted to the CAP instead of reviewed by the onsite inspector. If portfolio review is required, the case requirement number for the 2023 edition is larger: at least 20 cases (10 in detail and a log of 20 total) that cover the programs the laboratory supports.

In the laboratory general and point-of-care testing checklists, two requirements related to competency assessment were revised to contain specific information for laboratories with California laboratory licensure. GEN.55499 and POC.06875, Competency Assessment—Waived Testing, require that the competency of personnel who perform waived testing be assessed for each test system after an individual has performed duties for one year and at least annually thereafter (as well as when problems with an individual’s performance are identified). If state and local regulations are more stringent, they must be followed. The requirements now clarify that laboratories with California laboratory licensure must also assess competency for waived testing at least semiannually during the first year an individual tests patient specimens and annually thereafter.

“Because the CAP has deemed status with the state of California, the CAP must ensure that labs there follow both CLIA and California lab regulations,” Dr. Sarewitz says.

Next month: What’s new in the
all common, hematology and coagulation,
and molecular pathology checklists.

In addition, the requirements list six elements of competency assessment for assessment of waived testing personnel. “Laboratories with California laboratory licensure must evaluate five of the six elements for competency assessment for waived testing, whereas the generic portion of the CAP requirement allows labs to select any element or elements as the lab itself sees fit,” Dr. Sarewitz explains.

GEN.55510 and POC.06920, Competency Assessment—Assessor Qualifications, contain requirements for the qualifications of those who perform competency assessments for all levels of test complexity. For waived testing, those qualifications may be determined by the lab director, except for labs with California licensure. “For California laboratories, personnel responsible for assessment of waived testing must meet the qualifications of a waived laboratory supervisor,” as detailed in GEN.78250, Dr. Sarewitz says.

The CAP will provide on Oct. 18 (noon to 1 pm CST) its Focus on Compliance webinar (registration open on www.cap.org), during which the key checklist changes in the new edition will be explained. Other compliance-related resources for CAP-accredited labs can be found on www.cap.org, including past Focus on Compliance webinars and lab inspection preparation videos, answers to the most common checklist-related questions, a self- and post-inspection toolbox, and customizable templates and forms for, among other things, competency assessment and quality management.

Valerie Neff Newitt is a writer in Audubon, Pa.