The CAP urged the Department of Health and Human Services (HHS) and other key federal agencies to take immediate actions to increase the supply of sodium citrate light blue-top tubes used for coagulation testing. Pathologists across the country have reported shortages in their laboratories and are seeking guidance for providing these important tests until blue-top tube supply levels are adequate.

The pandemic has disrupted various industries and supply chains across the globe. Pathologists have worked to overcome challenges with obtaining supplies related to COVID-19 testing, but in recent weeks critical shortages of blue-top tubes have drawn concern over continued patient access to coagulation tests from pathologists across the United States. In the June 7 letter to HHS Secretary Xavier Becerra, the CAP asked for immediate actions from the Biden Administration to resolve the supply shortage of blue-top tubes.

Blue-top tubes are used for specimen collection for coagulation testing. Coagulation tests measure the blood’s ability to clot, and how long it takes to clot. This testing determines the risk of excessive bleeding or developing clots (thrombosis) in blood vessels. Clotting disorders can cause dangerous levels of bleeding, which can be life threatening. The CAP insisted that the HHS address this critical shortage by also providing “guidance so clinical laboratories can identify and/or create alternative collection methods, including validation processes for development of sodium nitrate tubes within clinical laboratories.”

FDA Takes Initial Actions

The CAP has also discussed the issue with the Food and Drug Administration (FDA) and on June 11 the agency added the sodium citrate blood specimen tubes to its list of medical device shortages during the COVID-19 public health emergency. The FDA released guidance on the blue tops shortage and conservation strategies for pathologists and laboratory professionals. They include:

• Do not include sodium citrate (light blue top) tubes in routine collections of a variety of specimens at the time of other blood sampling or IV insertion.
• Do not use sodium citrate (light blue top) tubes unless medically necessary.
• Do not use sodium citrate (light blue top) tubes as discard tubes; consider clear top or red stopper (no additive) tubes as an alternative.
• Limit allocation of 1.8mL sodium citrate (light blue top) tubes for difficult blood collections.

The FDA also recommended health care and laboratory facilities develop and implement the above strategies to minimize the use of these tubes and maintain the quality and safety of care for patients for whom such testing is medically necessary.

The FDA 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.

The CAP is scheduled to discuss the shortage further with the agency. The CAP will update pathologists and the laboratories they direct when further developments are announced.