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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Overland Park Regional Medical Center 16-Jul-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340

Telephone: (913) 752-2100


July 16, 2007

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref. KAN 2007-10

Steven M. Anderson
Chief Executive Officer
Overland Park Regional Medical Center
10500 Quivira Road
Overland Park, Kansas 66215-2306

Dear Mr. Anderson:

During an inspection of your blood bank located at 10500 Quivira Road, Overland Park, Kansas, between April 16, 2007 and May 23, 2007, an FDA investigator from this office documented numerous deviations from the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of Federal Regulations (CFR), Part 606. These deviations cause your products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 351(a)(2)0)]. The deviations include the following, among others:

Failure to adequately provide for identification and handling of all test samples so that they are accurately related to, the specific unit of product being tested and to the specific recipient [21 CFR 606.140(c)]. For example:

On 2/24/06, the blood bank received a specimen for a patient, from which two units of A-positive blood were cross matched. Prior to the blood being given to the patient, the lab was notified that there had been a mix-up in patient identification on the blood specimens. The above patient had an AB-positive blood type rather than A-positive.

The investigation report showed no follow-up was conducted, no action taken, and no selection of severity level.

Failure to prepare and maintain written reports of investigations of adverse reaction, including conclusions and follow up according to your SOP [21 CFR 606.170(a)]. For example:

You 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.

• Patient [redacted] was transfused two units of thawed fresh frozen plasma on 2/2/07 at 2330. A transfusion reaction was noted 2/3/07 at 0115 and 0045; the amount transfused was 300 + 300mls.

The Transfusion Reaction Form dated 2/2/07 Pathologist comments stated, Dyspnea reported after transfusion of 600mls of FFP. No other symptoms reported. Consider Volume overload and TRALI (Transfusion Related Lung Injury) in differential diagnosis.

• Patient [redacted] was transfused one unit of Leukopoor Pack Cells on 1/3/07 at 1640. A transfusion reaction was noted on 1/31/07 at 1800; the amount transfused was 175 mls. The transfusion was stopped at 1800.

The Transfusion Reaction Form dated 1/31/07 Pathologist comments state, "Shortness of breath reported after transfusion of 175 mls of FFP. No other symptoms reported. Consider volume overload and TRALI (Transfusion Related Lung Injury) in diff dx."

Failure to make and record a thorough investigation, including conclusions and follow-up; of any unexplained discrepancy or the failure of a unit or lot to meet specifications, and to extend the investigation to other products that may have been associated with the discrepancy or failure [21 CFR 606.100(c)]. For example:

• Investigation Summary dated 5/11/06 has no documented evidence of an investigation concerning an incorrectly entered antibody screen.

• Investigation Summaries dated-4/27/06 and 5/17/06 has no actions taken concerning incorrect reporting of blood types.

Our office is in receipt of your letter dated May 21, 2007 addressing the initial steps you are taking to correct the deviations noted on the FDA 483 - Inspectional Observations issued at the close of the inspection on April 23, 2007. We have reviewed this response and find the corrective actions, in general, to be isolated to the observations of the FDA 483. This response does not address any underlying problems which may be causing the-deviations. Your response does not provide assurance to our office that you have taken effective measures necessary to prevent recurrence of the deviations.

The deviations identified above are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the federal regulations. You should take prompt measures to correct these deviations. Failure to correct these deviations promptly may result in administrative and/or regulatory action without further notice. Such action may include seizure and/or injunction.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you will take, in addition to. your May 21st letter, to correct the noted violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Please send your reply to the U.S. Food and Drug Administration, Attention: Nadine Nanko Johnson, Compliance Officer, at the address noted in the letterhead. If you have any questions regarding any issue in this letter, please contact Nadine Nanko Johnson at (913) 752-2781.

Sincerely,

/S/

John W. Thorsky
District Director
Kansas City District

cc: Roderick L. Bremby, Secretary
Kansas Dept. of Health and Environment
Curtis State Office Bldg.
1000 SW Jackson
Topeka, KS 66612

Paul Shumate, Branch Manager
Survey and Certification
Centers for Medicare and Medicaid Services
Richard Bolling Federal Bldg.
601 E. 12th Street, Suite 235
Kansas City, MO 64106