Regulatory News and Updates for Laboratories (2024)

August 28, 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?
   A verification study (COM.40300) is required for bottles listed as approved by the manufacturer, if these were not previously included in the laboratory’s verification. The extent of this verification is at the discretion of the laboratory director.

   If the new blood culture bottles are 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.

May 17, 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 publish in late October or November. Laboratories must continue to follow their current checklist edition until that time.

Watch: CLIA Final Rule: Resources for Accreditation and PT Customers

Register for Upcoming Webinar: Learn about the Checklist changes at the November 20 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.

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.