Regulatory News and Updates for Laboratories

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.

June 20, 2024

Pathologists and laboratories will consider several factors to determine if a test must meet Food and Drug Administration (FDA) regulatory requirements for laboratory-developed tests (LDTs). See the FDA Oversight of LDTs Phase 1 Requirements table for the first stage or phase of requirements beginning May 6, 2025.

Phase 1 Requirements Starting May 6, 2025

Medical device reporting: Laboratories must report certain device-related adverse events and product problems to the FDA.

• FDA Resource: Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities

Correction and Removal: Required to make a report to the FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the act caused by the device which may present a risk to health.

• FDA Resource: Recalls, Corrections and Removals (Devices)

Quality system for complaints requirements:

• Maintain complaint files.
• Designate a formal complaint handling unit.
• Establish and maintain procedures for receiving, reviewing, and evaluating complaints.

Read more on Laboratory-Developed Test Oversight.

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