Blood bank nets 8-item 483 for quality control failures.

Mississippi Blood Services, Jackson, MS, New Orleans District

Serious lapses in quality control and documentation landed Mississippi Blood Services an eight-item 483, for which the firm received a subsequent warning letter from FDA. The audit was conducted by Eddie Rigsby of FDA's New Orleans District. The EIR was not available at press time.

FDA uncovered numerous quality control deficiencies with respect to the firm's handling of deglycerolized red blood cells.

Several units of the blood cells were listed as sold in the firm's computer system; however, "the firm has no documentation that QC was performed on the refractometer used in processing these units," the 483 stated.

Apparently, some of the units were recalled by lab management because of the failure to perform QC on the refractometer; yet, lab management failed to notify the firm's QA unit. The firm had no documentation of the final disposition of these units, according to the 483.

In addition, certain [unnamed] units were listed as sold in the firm's computer system; however, the "preparation of these units was not documented on the Deglycerolized Blood Cell Log that documents the lot number and expiration date of the blood cell processor set and reagents used in processing the product, and the refractive index of the product's resultant wash," the 483 stated.

The blood bank also was cited in the 483 for numerous deficiencies related to Apheresis Platelets. For example, the firm "routinely released" Apheresis Platelets that did not meet instrument manufacturer's specifications. In addition, there was "no follow-up to determine if corrective action was effective in regards to the 2/2001 failed Apheresis Platelet QC," according to the 483.

The 483 stated that no platelet count was performed prior to release on the "A and B splits of [unnamed] units." Further, the firm's SOP specifies that platelet storage temperature range from 18-22[degrees]C. Yet, platelet labels specify 20-24[degrees]C.

Another failed QC deficiency was uncovered with respect to the firm's Leukocyte Red Blood Cells. The firm failed to follow its SOP into failed units in February 2002, according to the 483. It also noted that "[f]ailed QC is not always reported to Compliance per SOP." Also, units determined unsuitable are "not always destroyed in a timely manner." Three examples were listed on the 483.

With respect to potential duplicate donor searches, FDA found document problems because the firm did not consider several scenarios that could be attributed to donor duplicates. In addition, the firm's SOP was deemed inadequate because it did not present criteria for eliminating possible donor matches.

The firm got into trouble because it had no written procedures describing the destruction of expired products, and the discard inventory log listing destroyed expired products was not verified or reviewed, according to the 483.

Numerous additional deficiencies were noted on the 483 with respect to written procedures not being updated to include operational procedures. The 483 also stated that attachments to SOPs are not always identified with SOP name, page number and revision date.

Investigators uncovered problems with the blood bank's irradiation of blood products. Specifically, the "Agreement for Irradiation Services with [unnamed entity] does not accurately reflect the services provided," the 483 stated. Additionally, the 483 stated the firm's management "has never reviewed the blood products irradiation log."

The firm's training procedures were found to be inadequate as well. For example, annual written tests were not given to laboratory personnel as specified in the firm's SOP. Similarly, employees are not observed annually to demonstrate continued competence as specified in the firm's training program, and there was no reference for specific training checklists as specified in the firm's SOPs.

In a July 7, 2002 response letter to FDA, Linda Wagner, vice president, Regulatory Affairs and Compliance Officer, provided an extensive plan with projected timelines for correcting deficiencies observed during the April inspection.

For example, the firm initiated a daily review of the "Refractometer Quality Control Log," and a Biological Product Deviation report was submitted to CBER. The firm is revising its SOPs with respect to the deglycerolization of adult and pediatric red blood cells as well as modifying the log to include a column for QC results.

Wagner notified FDA that a Quality Assurance Committee was initiated to review current criteria for labeling of Apheresis Platelets, and the SOP for processing leukocyte-reduced plateletpheresis units was revised. Variance investigations also were initiated, and a BPD report will be submitted to CBER, the letter stated.

With respect to potential duplicate donor searches, Wagner reported that the records would be revised to allow for more possible scenarios to better identify duplicates.

Wagner outlined the firm's plans to develop and implement a facility-wide training program to ensure consistency and standardization of training.

Firm's response unacceptable to FDA

However, FDA found the firm's response unacceptable and issued a warning letter on July 2, 2002, for failing "to perform quality control on and calibration of the refractometer used to determine the refractive index of red blood cells in the processing of deglycerolized red blood cells [21 CFR 606.60(a) and (b)]. In addition, the warning letter stated that numerous deficiencies "were documented related to your firm's failure to follow written standard operating procedures."

The warning letter also stated that the firm "failed to establish scientifically sound and appropriate specifications to assure that apheresis platelets are safe, pure, potent and effective."

Linda Wagner wrote another letter to FDA out-lining a more detailed response to the deficiencies out-lined in the 483 and warning letter. She outlined root causes analyses and corrective actions for each of the observations listed on the 483.

* For example, with respect to FDA's observation about the firm's failures to perform quality control and calibration of the refractometer, Wagner wrote that the root cause analysis discovered that documentation of the steps performed in the deglycerolization process "was recorded on two separate forms (Refractometer QC Log and Deglycerolized Red Blood Cell Log) and the forms were filed separately. The potential for misplaced/lost QC documentation would be eliminated if all steps associated with the deglycerolization process was recorded on one form."

In a telephone interview, Linda Wagner, reported that all deficiencies have been corrected. She said the firm was recently inspected in April 2003 and no 483 was issued.

Mississippi Blood Services, Jackson, MS, 3/25-4/2, 8, 12/02, Doc. 109507M, $13.50 plus retrieval.