Performing Waived Molecular tests? Understand the changes coming in April!

Bobbi Pritt, MD, chair of the College of American Pathologists (CAP) microbiology committee, answers questions about upcoming changes for CAP-accredited laboratories, coming up in April.

CAP-accredited medical laboratories that perform waived molecular will be expected to conform to a four additional safeguards effective April 2020:

1. Establish written procedures to monitor for the presence of false-positive results.
2. Establish written procedures to prevent specimen loss, alteration, or contamination during collection, transport, processing, and storage.
3. Establish written policies for safely handling and processing samples from patients with suspected infection due to avian influenza, SARS, Ebola, or similar emerging pathogens.
4. Lab report should include a summary of the test method and information regarding clinical interpretation, if appropriate

Approximately 15,500 labs in the U.S. are accredited by a CMS-approved accreditation organization. Of those, CAP accredits about 6,300. (Statistics current as of April 2019.)

Bobbi Pritt, M.D., MSc, DTM&H, chair of the CAP Microbiology Committee and professor, Mayo Clinic Alix School of Medicine, responded to questions about the changes and how physician offices can comply.

Q: When are labs expected to comply with these new requirements?

Bobbi Pritt: Labs that are inspected around April 2020 will be the first to be inspected with the 2019 edition of the checklist. The CAP makes its checklists available electronically to CAP-accredited laboratories so that they can start working on coming into new compliance with new or revised requirements immediately after they are published. However, they will not be evaluated for compliance with the new requirements until their next onsite inspection with the new checklist edition. Laboratories have on-site inspections every two years, with an interim self-inspection every other year.

Q: How binding are the CAP checklists and the Laboratory Accreditation Program?

Dr. Pritt: The CAP’s Laboratory Accreditation Program has deeming authority with the Centers for Medicare and Medicaid Services (CMS) as an approved accrediting organization. So, if a laboratory is using the CAP as its accreditor for CLIA compliance, its CAP accreditation is very important.

Laboratories that are accredited by CAP are expected to comply with all the checklist requirements. They are not optional. Laboratories are required to demonstrate compliance with all phase I and phase II checklist requirements. If a laboratory is found to be out of compliance during an onsite inspection, it will be cited with a deficiency and is required to submit documentation of corrective action within 30 days after the inspection. A laboratory’s accreditation decision is dependent on correction of all deficiencies. This includes the four new requirements.

Q: The first new checklist requirement -- POC.08675 Quality Monitoring Statistics -- calls for written procedures to monitor for the presence of false-positive results (owing to nucleic acid contamination, for example) for all molecular microbiology tests. Is this a departure from today’s standard practice? If so, how?

Dr. Pritt: Yes, this will be a new process for many labs performing only waived testing. However, it is important for all settings that are using new molecular amplification tests, even if they have a CLIA waived status, since DNA contamination is a real risk and can result in false positive patient results. Having a false positive result could lead to unnecessary treatment and a failure to test for the true cause of the patient’s illness. The benefit of monitoring for false-positive results is that laboratories can have an additional layer of assurance that their test results are accurate and that they are providing the best results possible for their patient.

Q: The second new checklist requirement -- POC.08690 Specimen Handling Procedures -- calls for written procedures to prevent specimen loss, alteration, or contamination during collection, transport, processing, and storage. Is this a departure from current practice? If so, how? And who would be responsible for this?

Dr. Pritt: This may be a new process for some settings where these types of procedures were not previously in place. However, having procedures for specimen handling is a widely acknowledged best practice and something that all settings that perform patient specimen testing should adhere to. The medical director of the testing facility would be responsible for ensuring that the components of this new checklist requirement are met.

Q: The third new checklist requirement -- POC.08715 Safe Specimen Handling/Processing -- says there must be written policies for safe handling and processing samples from patients with suspected infection due to avian influenza, SARS, Ebola, or similar emerging pathogens. Is this a departure from current practice? If so, how? 

Dr. Pritt: Yes, this is also a new practice that many laboratories may not have previously implemented. Many healthcare facilities that provide waived, point-of-care testing may not consider that they could be the first ones to encounter patients infected with high-consequence infectious diseases. Therefore, this new checklist requirement will help to raise awareness and ensure that these settings are prepared. Not all labs may currently follow this practice, but it is widely recognized as best practice.

Q: The fourth new checklist requirement -- POC.08730 Final Report -- calls for the report to include a summary of the test method and information regarding clinical interpretation, if appropriate. What is the rationale for this requirement?

Dr. Pritt: Now that we are starting to get into multiple testing options -- antigen tests, PCR tests -- it’s important to include the method in the name or description of the test on the report, so that clinicians reading the report can use this information to interpret the significance of the result. For example, if a patient was tested by a less sensitive influenza antigen detection method, then it may not be safe to rule out influenza in that patient.

To learn more about the history and rationale for the new checklist requirements, read “New requirements for molecular micro testing,” September 2019 CAP Today, at https://www.captodayonline.com/new-requirements-for-molecular-micro-waived-testing/

The Q&A originally appeared as a blog online at Repertoire Magazine: http://www.repertoiremag.com/sell-waived-molecular-tests-your-customers-face-some-changes-in-april.html