With a national shortage of certain test tubes to collect blood for coagulation testing, the 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 Food and Drug Administration (FDA). Shortages are expected to continue throughout the rest of 2021.

Coagulation tests measure the blood’s ability to clot and how long the body will take to clot. This testing determines the risk of excessive bleeding or developing clots (thrombosis) in blood vessels. The CAP recommendations aim to reduce clinical impact of shortages and protect critical patient access to coagulation testing.

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.

What To Do If Your Laboratory Has Shortages?

The FDA has encouraged pathologists and other providers to report any adverse events or suspected adverse events experienced with the tubes. If you or your laboratory is experiencing shortages, you may contact the FDA at deviceshortages@fda.hhs.gov.

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.