Advocacy Update

January 25, 2022

In this Issue:

FDA Releases Blood Collection Tube Conservation Strategies

The US Food and Drug Administration (FDA) added all blood draw tubes to its medical device shortage list on January 19. The shortage stems from an increase in demand and vendor supply challenges during the COVID-19 public health emergency, the FDA said. The agency also released several recommendations to conserve the tubes and mitigate shortages.

Previously, the FDA had issued a letter to health care and laboratory personnel on June 10, 2021, regarding a shortage of sodium citrate blood specimen collection (light blue top) tubes. The FDA action came after the CAP had also raised the shortage to the Department of Health and Human Services (HHS).

In its latest recommendations, the FDA urged that health care providers, laboratory directors, phlebotomists, and other personnel minimize blood collection tubes by performing blood draws only if medically necessary and consider sharing samples between laboratory departments if specimens are already available. Other conservation strategies include:

  • Reduce tests at routine wellness visits and allergy testing only to those that target specific disease states or where it will change patient treatment.
  • Consider add-on testing or sharing samples between laboratory departments if previously collected specimens are available.
  • If you need a discard tube, use a tube type that has a greater quantity available at your facility.
  • Consider point of care testing that does not require using blood specimen collection tubes (lateral flow tests).

The FDA is monitoring the current situation to help ensure blood testing remains available for patients where testing is medically necessary. The CAP will share any subsequent updates with its members.

CMS Extends Timeline for Feedback on Proposed CLIA Regulations

Citing a delay due to resources and the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) extended the timeframe for finalizing proposed CLIA regulatory changes regarding integrity and proficiency testing previously announced.

In 2019 the CMS released a proposed regulation “the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance.” This proposal would update PT regulations under CLIA to address current analytes and newer technologies. Also, the proposed regulation offered additional technical changes to PT referral regulations to align with statute. This is the first update to the CLIA PT regulations since its inception.

In 2019, the CAP encouraged the CMS to add additional regulated analytics to the current CLIA program. Moreover, the CAP supported the agency’s effort to modernize the proposed regulations updating the analytics to align with clinical laboratory practices. The CAP encouraged the updated list of regulated analytes, including the addition of the 29 and the deletion of six proposed analytes. The CAP also supported some changes to the PT programs, such as allowing a CMS onsite visit, re-affirming non-profit status for PT providers, and outlining parameters for PT programs to set up peer-groups and PT offerings.

In addition, the CAP urged the CMS to consider adding analytes in the specialty of toxicology. The CAP also asked the CMS to clarify the regulations of the administrative responsibilities required to be non-profit, peer-group requirements. Finally, the CAP urged the CMS to rescind several proposals from the rule because of the potential burden and cost to laboratories. These proposals include laboratories’ declaration of patient reporting practices to PT programs, reporting microbiology organisms to PT programs at the highest level, and the one-time online submission of PT data. The CAP emphasized a key to modernizing PT regulations is to fix the cytology PT program and allow electronic signatures with electronic PT submissions for regulated analytes.

Missed the Implementation of Pathology Consultation Codes Webinar? Watch the Recording.

Did you miss Implementation of Pathology Consultation Codes Webinar? Check out the recording and download the slides.

Last Week to Test Your January Advocacy Knowledge

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