Revised FDA Policy Statement on Urgent Collection, Shipment, and Use of Whole Blood and Blood Components Intended for Transfusion

September 14, 2001

This policy statement is intended to supercede the "FDA Policy Statement on Urgent Collection, Shipment and Use of Whole Blood and Blood Components Intended For Transfusion to Address Blood Supply Needs in the Current Disaster Situation" issued on 9/11/01. FDA recommends that the revised recommendations should be implemented immediately.

Recent communications with major blood organizations and local blood suppliers in the metropolitan New York and Washington D.C. areas have indicated that supplies of blood and blood components for transfusion are sufficient to meet current needs. Collection volumes are anticipated to remain higher than normal in the near future as volunteers continue to present for blood donation based on earlier appeals. Additionally, the continued restrictions on routine air transport services nationwide has affected the shipment of some samples for routine laboratory testing, as well as the availability of supplies and reagents, including test kits, needed for processing collected blood.

FDA therefore is revising its policy statement regarding urgent collection procedures.

Training and certification of emergency staff members for blood collection procedures

  1. Non-routine training and certification of emergency staff, as described in the FDA policy statement issued on 9/11/01, should be discontinued.
  2. Staff members who were not fully trained and certified by routine standard operating procedures (SOP's) should cease to perform phlebotomies and should cease to make final determinations of donor suitability based on the donor history.
  3. All use of staff members who were not fully trained and certified by routine standard operating procedures (SOP's) should be discontinued as soon as feasible.
  • Note: Emergency staff who were fully trained and certified (per routine SOP) for a limited set of procedures, but not the full set of procedures normally included in the job function, could continue to perform the limited procedures for which they were fully trained and certified.

Quality Assurance investigation of blood and blood components collected under urgent conditions

As soon as feasible, but no later than three working days after the date of this notice, blood collection facilities should complete a quality assurance review of all blood products prepared with the involvement of emergency staff members to assure that all SOP's were followed. Unsuitable units should be removed from the inventory consistent with established procedures for product deviations.

Release of units that are not fully tested

Blood products for transfusion should not be released without completion of all required and recommended tests. (Routine exceptions for documented medical emergencies still apply.)

  • Note: Nucleic acid tests (NAT) may remain unavailable at some centers. For products released without (or prior to) completion of NAT testing, the unit should be labeled to identify the tests that were not performed.

Availability of test kits and other reagents is being monitored by FDA and major blood collection organizations. At the present time, needs are being met through the use of ground transportation and limited air transport. Blood centers should attempt to anticipate reagent shortages and provide notice as soon as possible to the appropriate supplier. In the event that reagent supplies become critically limited, FDA will update its guidance on release of units that cannot be fully tested by routine procedures.

Shipping unlicensed blood components in interstate commerce

Shipment of unlicensed blood components in interstate commerce should be discontinued except for well-documented medical emergencies.

Product Identification and Recordkeeping

  1. The blood collection facility should maintain a mechanism for identification of the blood products that are collected under emergency conditions.
  2. Hospital transfusion services should continue to maintain a record of issuance of units that were labeled "For Emergency Use Only" including the fact of any donor screening tests that were not fully completed at the time of issuance.

Use of alternative FDA-registered laboratory test facilities

Some blood collection centers are experiencing difficulties in transporting blood samples to their routine laboratory testing facilities and may be using alternate laboratory test facilities. For licensed blood collection centers that wish temporarily to use alternative laboratories without prior FDA approval, FDA intends to exercise its enforcement discretion provided that the alternative laboratory is FDA registered. However, notice to FDA should be provided by calling an FDA staff member at (301) 827-3543, or by faxing a statement to (301) 827-3534. Additionally, a Change Being Effected (CBE) supplement should be submitted as soon as feasible.

Blood centers may contact the Division of Blood Applications, Office of Blood Research and Review, FDA at (301) 827-3543 for questions about these revised procedures. For emergency concerns, contact should be made to FDA Emergency Operations at (301) 443-1240.

 
Updated: September 14, 2001