FDA notes inadequate staffing, poor quality control at NJ Blood Center.

FDA investigators Sarah Forney and Helen Ricalde issued a 483 following an Aug. 17-Dec. 27, 2007, inspection of the Blood Center of New Jersey (BCNJ). On three occasions, the company failed to have a qualified physician or trained person under a doctor's supervision determine the suitability of a blood donor on the day the blood was collected, according to the review.

In response, the East Orange, NJ, center pledged to revise its donor registration card audit review procedures to require a maximum time of 24 hours to contact donors to resolve any issues. "If resolution is not obtained in 24 hours from collection, the unit will be considered unsuitable and will be discarded," the facility wrote in its response to the Form 483.

The investigators cited the blood center for failing to assure the appropriate number of personnel at mobile blood drives. They noted that a blood drive at Bloomfield College "was 92% over the planned number with 25 donors expected and 48 registered," while at County College Morris 70 donors were expected but 96 registered. "No additional staff was dispatched to the drive to assist with the increased number of donors," Forney and Ricalde wrote.

The inspection found 246 incidents of overweight units collected from January through October 2007, and also noted several instances of mistakes made by certain phlebotomists during a mobile drive.

The inspectors stated the blood center did not thoroughly investigate each report of an adverse reaction, referring to several such events involving lacerations at the needle site, possible nerve irritation, possible cases of phlebitis and swelling. The center responded that it had begun to monitor phlebotomy problems under a new Error Management procedure; to have Donor Services review all post-donation injury reports and to directly contact donors with injuries that might take some time to resolve; to monitor these reports for appropriate documentation and follow-up; and would "instruct on the proper documentation of needle adjustments."

BCNJ failed to follow and maintain standard procedures for determining donor suitability, the 483 continued. The center had no written standard procedure for contacting donors to obtain post-donation information and determine suitability within 24 hours of donation or for determining the suitability of donors who report an illness within 72 hours after donation.

Forney and Ricalde also cited BCNJ for accepting donations from donors who were not in good health based on criteria relating to body temperature and blood hemoglobin levels. In both cases, the center stated that deviations regarding missed criteria for donor acceptability "will be accepted ONLY when out-of-trend cause analysis is properly evaluated and appropriate correction and review has been discussed with the employee."

The investigators also observed that the center's procedures for the steps to be followed at all stages of blood collection and handling were not always followed, they stated in the 483. The firm had failed to notify a consignee about repeatedly reactive HCV results for one unit, as required.

BCNJ replied that it had revised or would revise its procedures as required to address these issues. Its SOP on quality control of leukoreduced red blood cells and whole blood was revised to clarify the acceptability of products tested. The failure to notify the consignee was "human error" and was immediately corrected, the response noted. The center pledged to revise its procedures to ensure that the medical director reviewed each report of donor injury or reaction, and would review procedures to ensure their adequacy and compliance on other issues.

Blood Center of New Jersey, East Orange, NJ, 8/17/07, 12/27/07, Doc. 110104, $16 plus retrieval

[check] The Checklist -- Blood Center of NJ

[check] Personnel not adequate for donor numbers 

[check] Delayed investigation

[check] Blood collection & handling procedures not followed