The College of American Pathologists (CAP) has released its updated checklists for 2024, bringing several significant changes across various accreditation programs. Staying informed about these revisions is crucial for laboratories to maintain compliance and ensure a smooth accreditation process. This blog post summarizes the key substantive changes found in the Common, Director Assessment, Reproductive Laboratory, and Laboratory General checklists.

Common Checklist (COM) Updates

The Common Checklist, which applies to all laboratories, sees several key clarifications and new additions. One notable change is to COM.01200, where the activity menu must now be accurate for all related information, not just test activities. Additionally, laboratories subject to CLIA regulations must now explicitly list patient-specific results on the CAP Activity Menu, a change from the previous wording of “reported to.”

New qualifications for technical supervisors have been added for the specialties of Cytogenetics and Transfusion Medicine (COM.01400), and a new requirement (GEN.41096) has merged with the existing COM.22950 from 2023.

Director Assessment (DRA) Checklist: Focus on Qualifications and Remote Oversight

The Director Assessment Checklist introduces new requirements for high-complexity testing directors. A key change in DRA.10100 mandates that a doctoral degree holder must have at least 20 continuing education (CE) credit hours covering director responsibilities*. However, the This is a shift from the previous one-year laboratory training requirement. The same requirement has also been updated for moderate-complexity laboratory directors, who must now have board certification and at least one year of experience in directing or supervising nonwaived testing.

The checklist also introduces new rules for remote oversight. DRA.10432 and DRA.10433 are new requirements specifying on-site visit frequencies for laboratories, both inside and outside the US, respectively. A new requirement under DRA.10435 directs laboratories to have a specific policy for the frequency of on-site visits if the director’s activities are conducted remotely.

Reproductive Laboratory (RLM) Checklist: Enhanced Cryopreservation and Personnel Rules

The Reproductive Laboratory Checklist now includes a greater emphasis on back-up plans for temperature-dependent equipment. RLM.03955 has been revised to require process plans for utilizing back-up equipment, including protocols for emergent situations and an annual assessment of the equipment’s functionality. This is a significant update from the prior focus on simply having a plan.

Regarding personnel, a key change in RLM.10250 has removed “physical” from the list of acceptable bachelor’s degrees for embryology laboratory personnel, refining the qualifications for these roles. A new clause (RLM.10166) was added for Department of Defense laboratories, clarifying the process for evaluating the equivalency of qualifications for directors trained outside the US.

Laboratory General (GEN) Checklist: Extensive Revisions to Quality Control and Safety

The Laboratory General Checklist has undergone the most extensive changes, particularly concerning proficiency testing (PT), equipment maintenance, and safety.

Equipment and Maintenance:

• GEN.20180 now explicitly requires instrument maintenance and cleaning to be performed according to manufacturer instructions.
• A new requirement, GEN.20450, mandates a policy for preventive maintenance on instruments not in use for extended periods.
• Conversely, the requirement for inspecting refrigerators and freezers every six months for cleanliness (GEN.20665) has been removed.

Proficiency Testing (PT):

• Several new requirements have been added to reinforce best practices for PT.
• GEN.50505 requires PT results to be reported in accordance with the PT program’s instructions.
• GEN.50555 now mandates that laboratory policies for handling PT samples define acceptable testing conditions.
• The requirement for corrective action plans has been strengthened with GEN.50875, which states that the plan must now address all PT results that are not perfect, and GEN.50850, which specifies that the plan must be documented and approved by the director.
• The requirements for on-site reviews of PT results (GEN.51500 and GEN.51600) have been revised to include the process for evaluating and documenting the results.

Safety:

• The entire requirement for emergency eyewash and shower equipment (GEN.70010) has been replaced by two new ones (GEN.70020 and GEN.70030), which now explicitly require the equipment to be accessible, inspected, and maintained per ANSI standards, with specific instructions for weekly activations and visual examinations.
• The requirement for a chemical hygiene plan (GEN.60500) has been deleted.

By understanding these changes, laboratory professionals can proactively update their policies and procedures to align with the latest CAP standards, ensuring continued compliance and quality.

High Complexity Laboratory Director, 20 Continuing Education Requirements

* At the end of June 2025, the Centers for Medicare & Medicaid Services (CMS), which oversees the Clinical Laboratory Improvement Amendments (CLIA) program, announced it was suspending enforcement of its decision to require, as a condition for eligibility to serve as a High Complexity Laboratory Director, 20 continuing education (CE) credits in laboratory practice that cover CLIA laboratory director responsibilities.

To be consistent with this new CLIA requirement, earlier this year the American Board of Bioanalysis (ABB) mandated the same 20 CE credits for candidates seeking to sit for High Complexity Laboratory Director examinations (including HCLD, BCLD, PHLD, ELD and ALD). In light of CMS/CLIA’s decision to suspend enforcement of the 20 CE credit requirement, ABB decided to suspend this requirement from ABB’s eligibility criteria for high complexity laboratory director certification until such time that CMS decides to enforce this requirement. ABB also believes that its General Knowledge examination for laboratory directors covers this subject matter.

As a result, individuals who previously applied for HCLD, BCLD, PHLD, ELD, and ALD certification after December 28, 2024, do not have to meet this requirement.

Also consistent with CLIA regulations, ABB announced an alternative pathway for candidates whose doctoral degrees may not be in a chemical, biological, clinical or medical laboratory science, or medical technology. Under this pathway, applicants may qualify to take the HCLD, BCLD, PHLD, ELD, and ALD examinations by completing 16 credit hours of doctoral level coursework in a chemical, biological, clinical or medical laboratory science, or medical technology. This adjustment is intended to broaden access while ensuring candidates have the necessary academic preparation for high-complexity laboratory oversight.

Finally, the revised CLIA regulations did not have a provision to “grandfather” Clinical Consultants. Therefore, to qualify as a Clinical Consultant, all previously qualified laboratory directors would have to “requalify” as laboratory directors under the December 28, 2024, rules that require directors to have 20 CE credits in laboratory practice that cover laboratory director responsibilities. Since CLIA enforcement of that requirement has been suspended, individuals who qualified as Clinical Consultants before December 28, 2024, do not have to earn the 20 CE credits to continue to qualify as Clinical Consultants.

Tips for Performing Your CAP Self-Inspection

Performing a comprehensive self-inspection will help you achieve:

• Ongoing compliance with the CAP checklist requirements
• A continual state of readiness for your next on-site CAP inspection
• Improved laboratory performance and better patient care

1. Prepare

• Formalize a self-inspection procedure.
• View the Laboratory Data Report on e-LAB Solutions™ for accuracy.
• Notify the CAP of any demographic and/or test activity changes.
• Confirm that proficiency testing (PT) is being performed for each required analyte.
• Review the Laboratory Activity Menu with PT Options (or the Missing PT Enrollment) Reports for required PT program enrollment vs. alternate performance assessment.
• Notify CAP of any Activity Menu changes that may affect PT enrollment.
• Determine the date that the inspection will occur (this should be unannounced).
• Select a team to perform the unannounced inspection.
  • Involve a variety of staff levels.
  • Include a mix of supervisory staff, non-supervisory staff, residents, and fellows.
  • Consider using a sister facility and cross-discipline lines for a fresh, unbiased perspective.
• Encourage staff and inspectors to complete inspector education. To access the courses:

1. Go to cap.org and log in to e-LAB Solutions Suite with your individual user ID and password.
2. Select CAP Accreditation, CAP Accreditation Resources, Inspector Resources, Online Inspector Training.
3. Register for the Team Leader or Team Member training session.

2. Conduct

• Review previously cited deficiencies and proficiency testing performance.
• Check deficiency responses against current practice.
• Ensure compliance with each applicable checklist question, including any new CAP requirements.
• Communicate with a variety of staff levels.
• Include all personnel involved in the testing process, such as: phlebotomists, accessioning/processing techs, bench techs, and supervisors/managers.
• As you perform the self-inspection, consider how you would respond to the following if the supervisor or laboratory director was not present:
  • Are you prepared to explain a certain procedure or practice?
  • Do you know where various policies are located?
  • Do you know where quality control and instrument maintenance records are located?

3. Improve

• Conduct a summation conference.
• Review cited deficiencies.
• Develop and document a corrective action plan with appropriate staff members.
• Demonstrate implementation of the plan with a review of follow-up corrective action taken to ensure compliance.
• Self-inspection documentation must be readily accessible for the next on-site inspection.

Need assistance? Call 800-323-4040 or 847-832-7000 or email accred@cap.org.