The Centers for Medicare & Medicaid Services (CMS) has published final rule CMS-3326-F to update the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.

This final rule, published at the end of 2023 and being implemented this year, will specifically:

• Implement a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees.
• Amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update regulations to incorporate technological changes.
• Amend the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and on-site state monitoring) to allow for the imposition of such sanctions against non-compliant laboratories operating under Certificates of Waiver rather than limiting sanctions only to imposing principal sanctions of revocation, suspension, or limitation of a laboratory’s CLIA certificate.

This final rule went into effect on January 27 for the CLIA fee and alternative sanctions revision. The histocompatibility and personnel requirements will take effect on December 28, 2024. The publication was made possible through the efforts of Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems (DLS) staff, who reviewed, sorted, and drafted responses to more than 900 comments regarding the rule change.

You can find more information on CMS-3326-F here.

Access to International Organization for Standardization (ISO) 35001:2019

The Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems (DLS) has been authorized to offer laboratories access to the International Organization for Standardization (ISO) 35001:2019 – Biorisk management for laboratories and other related organizations.

Institutions seeking access must designate a point of contact (POC) to initiate the process and assist in distributing access within the institution.

Process Overview:

1. Your institution designates point of contact (POC) responsible for biorisk management, such as the Laboratory Director, Biosafety Officer, or designee.

2. The POC emails the DLS Biosafety mailbox at [email protected] to request access to the ISO 35001:2019 standard. The message must include your institution’s name and physical address.

3. If your institution is approved for access, DLS notifies your POC via email with further instructions. The POC must then submit names of individuals within your institution who would need to receive the ISO standard, including the following information:

• Individual’s name.
• Work email address (personal email addresses will not be accepted).
• Individual’s role in the organization.

This initiative aims to streamline the process and ensure that DLS has an organized list of individuals interested in receiving the ISO 35001:2019 standard within each organization.

DLS recognizes this ISO standard’s importance in enhancing biorisk management in laboratories and encourages your institution to participate. For questions, contact DLSBiosafety@cdc.gov.

Alert: Rocky Mountain Spotted Fever

The CDC has issued a Health Alert Network (HAN) message about an outbreak of Rocky Mountain spotted fever (RMSF) among people in the United States who recently traveled to or from the city of Tecate in the state of Baja California, Mexico.

If RMSF is suspected, whole blood and serum samples obtained from acutely ill people should be evaluated for Rickettsia by molecular and serologic testing methods available at commercial laboratories, state public health laboratories, or the CDC.

Providers are advised not to delay or withhold treatment pending receipt of laboratory test results or based on an initial negative test result. Polymerase chain reaction (PCR) amplification can be performed on whole blood, rash biopsy, or postmortem tissue but has low sensitivity early in the disease.

Serologic testing can also be performed on paired acute and convalescent serum samples collected 2 to 4 weeks apart. Serologic testing for detection of antibodies is frequently negative in the first week of illness. Diagnostic testing at CDC may allow retrospective laboratory confirmation in patients who die from the infection.

If Rickettsia-specific testing is not available in a jurisdiction, specimen submission to CDC can be coordinated through your state or local health department.

For more information, including recommendations for clinicians, public health professionals, and laboratories involved in specimen submission or diagnostic testing, review the HAN in detail.

Questions? We’re Here to Help!

ACHC is your partner in Clinical Laboratory Accreditation. For more information, contact your Account Advisor, email [email protected], or call (855) 937-2242.