Regulatory News and Updates for Laboratories

October 16, 2024

On December 28, 2023, the CMS released the Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F). This ruling includes changes to the CLIA regulations addressing personnel qualifications and histocompatibility testing, which will take effect on December 28, 2024. The CAP is in the process of incorporating necessary changes into the 2024 checklist edition, which is expected to published by the end of 2024. Laboratories must continue to follow their current checklist edition until that time.

Register for Upcoming Webinars: 

Learn about the checklist changes at the December 18 Focus on Compliance webinar, "Staying in Sync: CAP Accreditation Checklist Changes for 2024." Presenters Stephen Sarewitz, MD, FCAP, and Gregory A. Gagnon, MD, FCAP, will review the rationale for the 2024 requirement changes, identify laboratory/practice improvement opportunities to align with 2024 requirements, and explain how laboratories can use CAP resources to identify changes and compliance solutions. This will allow for a deeper discussion of the new checklist requirements, with limited focus on the CLIA personnel final rules.

On February 19, 2025, from 12:00–1:00 PM CT, the CAP will host a Focus on Compliance webinar, "Personnel Essentials: A Deep Dive into Personnel Roles and Qualifications." The webinar will cover CLIA roles and responsibilities, including updates based on the CLIA final rule changes. Attendees will gain a better understanding of who can assess competency, how to evaluate transcripts from “other” degrees, and explore the new templates and tip sheets available in the Accreditation Resources section of e-LAB Solutions Suite (ELSS). Register here.

September 17, 2024

On July 10, 2024, the FDA alerted laboratories that BD BACTEC blood culture bottles (PDF) are on the Medical Device Shortage List and provided a Letter to Health Care Providers to mitigate the impact on patient care and antimicrobial stewardship. The CAP is monitoring the shortage's impact on CAP-accredited laboratories.

The FDA, CDC, and Becton Dickinson (BD) provided recommendations for laboratories and other health care providers, including:

• Assessing your current inventory of blood culture media and utilization
• Prioritizing the use of blood culture media based on clinical need and following guidelines of local oversight committees
• Discontinuing routine collection of blood cultures prior to an order being placed
• Partnering with clinicians to define and implement conservation and/or rationing strategies, as necessary
• Emphasizing the importance of proper blood culture collection (volume, skin disinfection protocols) to optimize recovery and minimize the need to recollect
• Implementing other strategies under the direction of the medical director

Additional information on practical recommendations for managing inventory and patient testing, optimizing test quality, and implementing diagnostic stewardship measures may be found in the following CDC/IDSA Clinician Call recording: BD BACTEC Blood Culture Bottle Shortage - Hosted in partnership with ASM, SHEA and PIDS, and in the American Society For Microbiology (ASM) guideline, Managing Blood Culture Bottle Shortages.

Blood Culture Shortage Questions and Answers

1. Is it acceptable to use expired media?
   The CLIA regulation at § 493.1252(d) states reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. Unless the manufacturer has provided notice/documentation that the expiration date has been updated, laboratories should not use expired reagents/supplies.
   
   If the manufacturer extends the expiration date for certain lots of BD blood culture bottles, no additional studies would be needed. The laboratory must keep a copy of the communication extending the expiration date and address any new risks in their IQCP.
   
   For blood culture bottles which have not had their expiration dates extended, it is important to remember that their use would be considered a test modification requiring validation (COM.40350), and the test would become high complexity.
2. We are temporarily switching to a different blood culture media. What do we need to do?
   Since BD instruments only accommodate BD BACTEC bottles, using an alternative bottle type on the instrument is not possible. Blood culture bottles incubated offline are subject to the manual blood culture system requirements (MIC.22610 and MIC.22620) and media QC (MIC.11038) requirements, including performance of QC or use of an IQCP. While there must be assessment of laboratory-specific data included in the risk assessment, the IQCP option is not prescriptive on the amount of data or evidence required for the risk assessment. It is the laboratory director’s responsibility to determine the acceptable amount of data. The following are examples of historical sources of data that may be used as part of the risk assessment:
   
   • Records from visual quality checks of media upon receipt
   • Data regarding transport and storage conditions of media
   • Problem logs
   • Manufacturer's quality certificates.
3. In September 2024 glass bottles will be available from BD. Does switching require a verification/validation?
   The BD BACTEC test system is FDA-approved. Therefore, if the FDA has cleared the use of glass bottles for your blood culture system, verification (COM.40300) is required. If the FDA has not cleared the use of glass bottles, this constitutes a modification of the test system, and a more comprehensive validation (COM.40350) is required.
   
   Laboratories that have previously used glass blood culture bottles and have their historic verification/validation study will not be required to perform additional studies when the glass bottles are released. It is up to the laboratory director to determine if additional verification is needed.
4. If we switch to a different blood culture media due to the blood culture bottle shortage, do we need to reverify or revalidate the molecular assays that use positive blood culture broth as a specimen type? (Updated 9/17/24)
   If the laboratory is switching to a different blood culture media that is included in the manufacturer’s instructions for use, but was not initially included in the verification, a verification study (COM.40300) is required. The extent of this verification is at the discretion of the laboratory director.
   
   If the change is to the type of bottle only (such as switching from plastic to glass) and there is written communication from the manufacturer that the media within the glass bottle is the same as the media in the equivalent plastic bottle, the laboratory is responsible for evaluating the change and determining if the new bottle type will contribute to analytic interference in the assays performed on positive blood culture bottles (GEN.40942 - Specimen Container Analytic Interference). The laboratory director or designee must review clinical literature, as available, and evaluate information from the specimen container and instrument manufacturer to determine whether additional verification by the laboratory is necessary and approve the bottle type for use.
   
   If the new blood culture media is not included as an approved specimen type in the manufacturer’s instructions for use, validation (COM.40350) is required to ensure the test performs adequately and the method performance specifications are still acceptable.
   
   If the laboratory has an IQCP in place for the affected molecular assay(s), the laboratory must review and update the IQCP risk assessment as appropriate.
5. How should we handle proficiency testing (PT) during the blood culture bottle testing shortage?
   If your laboratory is unable to analyze PT for bacteriology programs where the specimens require inoculation of blood culture bottles, refer to the PT reporting instructions and properly document the rationale for not testing PT specimens. Alternative performance assessment must be performed. The laboratory may utilize clinical validation by chart review to meet requirements.
   
   If your laboratory is enrolled in bacteriology PT programs where specimen inoculation of blood culture bottles is not required, you must continue to perform PT challenges.

June 2, 2023

On May 11, 2023, the Centers for Medicare and Medicaid Services (CMS) issued memorandum QSO-23-15-CLIA, discontinuing the post-Public Health Emergency (PHE) reporting of SARS-CoV-2 test results to the state and public health authorities and clarifying the continued enforcement discretion for remote review of digital images, data, and reports.

SARS-CoV-2 Test Result Reporting Requirements

The requirement to report all SARS-CoV-2 test results ended with the expiration of the PHE . However, laboratories must still comply with state and local regulations and should verify the current guidance for the reporting of SARS-CoV-2 test results to their state and local public health authorities.

Checklist requirement GEN.41316 (Infectious Disease Reporting) will be revised to reflect the change to the federal mandate.

Remote Staff Performing Review of Digital Clinical Laboratory Data, Digital Results, and Digital Images

The enforcement discretion continues to allow pathologists and laboratory personnel to perform remote review of digital data, digital results, and digital images accessed by VPN (or other secured network), under the main laboratory’s CLIA certificate, provided the laboratory meets the criteria in memorandum QSO-23-15-CLIA. The test report must include the remote site location where the testing was performed, although a coding system (eg, site ABC) may be used in lieu of a personal address.

The CMS enforcement discretion does not extend to the remote review of glass slides. CMS’s rationale is that, “…a microscope and other laboratory equipment is necessary to perform the testing. The necessity of such equipment is a hallmark of a separate laboratory… Therefore, after the PHE has terminated, CMS will not continue to exercise its enforcement discretion for the review of physical slides.” If laboratories choose to continue to perform the review of glass slides remotely on a routine basis, they will need to obtain a CLIA certificate.

January 19, 2023

The Centers for Medicare and Medicaid Services (CMS) has recently clarified its stance on the reporting of cytogenetic testing results when portions of the analysis or interpretation are performed by personnel at a home testing site with a different CLIA number. The laboratory issuing the final patient report may include the name of the main laboratory and a unique code to indicate the location in lieu of including the home address on the patient report. For example, the patient report with the interpretation could indicate that a portion of the analysis was performed at [Name of Main Laboratory] – Site #5, where “Site #5” is an internal code known by the main laboratory as corresponding to a specific home location.

This change does not impact testing performed under the temporary CMS policy, QSO-20-21-CLIA, issued on March 26, 2020, which allows pathologists and other laboratory professionals (eg, cytogeneticists, cytotechnologists, toxicologists) to remotely review and report patient results from a temporary location (eg, an individual’s home) during the COVID-19 health care emergency. Under this policy, the temporary location is not required to obtain a separate CLIA certificate provided the scope of work performed remotely falls under the primary laboratory’s CLIA certificate. The name and address of temporary testing locations included under a laboratory’s CLIA certificate do not need to be separately listed on the patient report. Please note that the CMS policy is subject to change once the health care emergency is resolved.

September 16, 2024

The CAP accreditation checklists contain requirements for test method validation and adverse event reporting, which are used to ensure CLIA compliance. CAP-accredited laboratories may leverage the checklists to meet the FDA requirements. The 2024 accreditation checklist edition will not contain any new changes in response to the FDA LDT final rule.

The CAP continues to watch the FDA LDT Final Rule and timeline closely and will reevaluate any necessary updates for future checklist editions.

The CAP is a resource and partner as your laboratory prepares for upcoming regulations. For the latest resources, webinars, and advocacy efforts offered by the CAP to help you prepare for the five-stage phaseout policy please visit our Laboratory-Developed Test Oversight page.

October 10, 2024

Due to the impact of current hurricane activity and associated weather issues, we understand that the delivery and subsequent processing of proficiency testing programs by your laboratory may be delayed or otherwise impeded.

For customers impacted by Hurricane Helene, the Centers for Medicare & Medicaid Services (CMS) has authorized the use of the natural disaster/emergency exemption, and the CAP will automatically apply this exemption to those programs whose results are not returned and had due dates between September 30, 2024 and October 18, 2024.

Pease note that we are closely monitoring any impacts due to Hurricane Milton. In the event that CMS issues a natural disaster authorization related to Hurricane Milton, we will alert customers promptly and provide updates as needed.

If your laboratory is operational, please report results if possible. If additional accommodations are needed, contact the CAP for assistance.

Laboratory Accreditation

If you have questions related to an upcoming inspection or regarding deficiency response due dates, call a Customer Contact Center representative at 800-323-4040 (within the US) or 847-832-7000 (Country Code: 1, outside the US), Option 1, or email ContactCenter@cap.org.

Thank you for your continued support of the CAP. 

Get Ready for the PT CLIA Changes: Stay Ahead, Stay Compliant

• Watch the webinar recording, read FAQs, and download the presentation slides (PDF) from June 27, 2024 webinar, led by experts from the CAP Clinical Chemistry and Microbiology committees.
• Refer to the table linked here to review the new 2025 regulated analytes, their acceptance limits, and corresponding program codes and revised scoring criteria established by the Centers for Medicare & Medicaid Services (CMS) that meet all updated CLIA requirements.

May 22, 2024

The CMS released a final rule, CMS–3355–F, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance, published in the Federal Register on July 11, 2022. This is the first significant update to the CLIA regulations since 1992.

Based on the final rule, there are two dates that may impact some laboratories:

• January 1, 2025: Proficiency Testing Final Rule (CMS–3355–F) requirements related to PT program providers and laboratories, including PT enrollment, while effective July 11, 2024, will be implemented on January 1, 2025.
• August 10, 2022: CMS clarified that effective on this date, if a laboratory chooses to perform PT for waived testing, they will be subject to the same regulations and sanctions related to PT referral as laboratories that perform non-waived testing (§§ 493.20 and 493.25).

Access the following for the latest CAP guidance:

• The May 2024 issue of CAP Today, Q&A section
• Your laboratory's 2024 PT program participant summary (PS), accessible via e-LAB Solutions Suite
  • Participant summaries include detailed program-specific information on grading criteria changes
  • Participant summaries with detailed information are indicated by a note on the cover page

Proficiency testing is required for regulated analytes. To determine which results are submitted to CMS, the CAP follows a predefined precedence, unless otherwise specified by the laboratory. Our CMS Analyte Reporting Selections (PDF) reference guide helps you navigate your way through the process. Log in to e-LAB Solutions Suite to access your current analyte reporting selections.