8-item 483 handed to blood bank for poor identification of test samples.

Overland Park Regional Medical Center, Overland Park, KS, Lenexa, KS, District

Overland Park Regional Medical Center, Overland Park, KS, received an eight-item 483 in a 2007 audit because the blood bank failed to provide for identification and handling of all test samples so they are accurately related to the specific unit of product being tested and to the specific recipient.

A July 16 warning letter also was issued following the audit, which was conducted by Lenexa, KS, District Office investigator Ingrid Johnson.

According to FDA records, on Feb. 4, 2006, an investigation summary at the blood bank reported a specimen was received at 11:47 p.m. Two units of A-positive blood were cross matched for a patient. The nurse contacted the lab a few hours later and stated that the patient was not "Hollister arm-banded."

After verification, the EIR noted, it was discovered that the phlebotomist had drawn and arm banded the wrong patient. "The two A-positive units initially cross matched were not issued to [undisclosed]. A new specimen was drawn at 1:13 p.m. on the correct patient."

Next, the 483 stated that the facility's records failed to include dates of the various entries, show test results, include interruption of the results, show the expiration date assigned to specific products and to be as detailed as necessary to provide a history of work performed.

Specifically, one patient's test results were not recorded in the blood bank special antigen testing log book.

Another example: Review of records showed on 21 occasions in 2006 that no entry was made on the surgery blood bank refrigerator temperature record forms. "On May 4 and May 5, 2006, there was no entry for 36 hours and on Dec. 19 and 20, there was no entry for 24 hour," the report read.

Next, FDA documents stated that a biological product deviation report was not submitted.

For example, the blood bank did not perform quality control on July 13, 2006 and did not submit the report.

Further, the 483 noted that written reports of investigations of adverse reactions, including conclusions and follow-up, were not prepared and maintained.

Specifically, "Overland failed to thoroughly evaluate and investigate the following recipient transfusion reactions. For example, your firm did not notify the blood center that supplied the unit."

Also, the report documented the blood bank did not perform an investigation and make a record of the conclusions and follow-up of an unexplained discrepancy.

"There were not written investigations or specific instructions determining the root cause of the following events:

* "There was no documented evidence of an investigation or corrective action to the de viation when QC was not performed on July 13, 2006."

* An investigation summary dated May 11, 2006 stated: "Entered antibody screen as negative instead of positive." The problem was noted to be resolved. However, "there was not documented evidence of an investigation. For example, there was no evidence that the recipient's serological history was reviewed and no time recorded when the event occurred."

Further, the 483 stated that Overland's written SOPs, including all steps to be followed in the compatibility testing of blood and blood components for homologous transfusion and autologous transfusion was not always maintained and followed.

FDA also added: "Records are not concurrently maintained with the performance of each significant step in the collection, compatibility testing, and distribution of each unit of blood and blood components so that all steps can be clearly traced."

One investigation summary stated: "I entered the patient's type before the Du was completed. OR and PACU called and informed of the correct type. The type was changed in the computer." There was no corrective action and no investigation to prevent reoccurrence."

Overland Park Regional Medical Center, Overland Park, KS, 4/16-23/07, Doc. 109988M, $5 plus retrieval.