• With a national shortage of certain test tubes to collect blood for coagulation testing, the CAP published conservation recommendations.

Recommendations aim to reduce clinical impact of shortages and protect patient access to coagulation testing.

WASHINGTON—With a national shortage of certain test tubes to collect blood for coagulation testing, the College of American Pathologists (CAP) published recommendations on June 15 for ordering physicians, nurses, and laboratories to follow until supplies for the tubes return to normal levels. The CAP reviewed the recommendations to address the shortage of 3.2% sodium citrate blue top tubes with officials from the US Food and Drug Administration. Shortages are expected to persist throughout the rest of 2021.

Coagulation tests measure the blood’s ability to clot as well as how long the body will take to clot. This testing determines the risk of excessive bleeding or developing clots (thrombosis) in blood vessels.

“Clotting disorders can cause a dangerous amount of bleeding or clotting and, for many patients, are life-threatening,” said CAP President Patrick Godbey, MD, FCAP. “These are fundamental laboratory studies and correct treatment decisions rely on these tests. Without them, physicians are reduced to guessing. The urgency to guarantee the supply of blue top tubes cannot be overstated. The CAP appreciates the FDA’s attention to this issue and we recommend that physicians and other providers involved in ordering coagulation tests, collecting specimens, or conducting the tests review our recommendations to help mitigate this national shortage.”

The shortages of these tubes have occurred due to several recalls, along with unprecedented levels of demand for citrate products following surges in COVID-19 infection rates, COVID-19 vaccines, and treatment development. Since sodium citrate tubes supplies are not expected to meet demand until the end of the year, the CAP developed mitigation strategy recommendations to guide clinical laboratories and federal regulators in reducing the clinical impact of these shortages.

Read the CAP’s recommendations.

Prior to the CAP’s meeting with the FDA, the CAP wrote Health and Human Services Secretary Xavier Becerra on June 7 and asked for immediate actions from the administration to resolve the supply shortage. On June 11, the FDA added the sodium citrate blood specimen tubes to its list of medical device shortages during the COVID-19 public health emergency. The FDA further released guidance on the blue tops shortage and conservation strategies for pathologists and laboratory professionals.

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About the College of American Pathologists 

As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. As a 501(c)(6) membership organization, the CAP is the only entity representing pathologists with unrestricted advocacy capability and a political action committee, PathPAC. For more information, visit yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care. Read the CAP Annual Report.