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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Cameron Regional Medical Center 28-Mar-05

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 80 Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100


March 28, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
Ref. KAN 2005-08

Mr. Steven Huitt, President
Cameron Regional Medical Center
Board of Directors
Box 81
Lathrop, MO 64465

Dear Mr . Huitt:

During an inspection of the blood bank at Cameron Regional Medical Center, conducted January 31 through February 8, 2005, an 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)(B)]. The deviations included the following:

The personnel responsible for the collection of blood or blood components are not adequate in training and experience, including professional training as necessary to assure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess . [21 CFR 606.20(b)]

Written standard operating procedures including all steps to be followed in the collection and storage of blood and blood components for homologous transfusion and autologous transfusion are not always maintained and followed . [21 CFR 606.100(b)] Our investigator observed your firm's practice of collecting a unit of autologous whole blood. The phlebotomy site was not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.

Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained . Transfusion reaction investigation reporting does not document follow-up information to the investigation. [21 CFR 606.170(a)]

Records are not concurrently maintained with the performance of each significant step in the storage and distribution of each unit of blood and blood components so that all steps can be clearly traced . [21 CFR 606.160(a)(1)] The time of transfer of Fresh Frozen Plasma from the manufacturer's shipping container to the Blood Bank refrigerator is not documented . The reason for, and method of, destruction of blood products is not always documented.

The above identified deviations 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 promptly correct these deviations may result in regulatory action without further notice . Such action includes seizure and/or injunction.

Our office has repeatedly informed hospital management of their non-compliance with the current Good Manufacturing Practice for Blood and Blood Components . In addition to the annual inspections FDA has conducted of your blood bank, each of which has resulted in documented violations of Federal Regulations, our office has also held two Regulatory Meetings with your Hospital Administrator and management personnel in October 1999 and October 2004 . Previously, a Warning Letter was sent your hospital on June 15, 1998 . Following each of these events hospital management promised to implement effective and lasting compliance. However, those promises have not yet been effectively executed.

Our office is in receipt of a letter dated March 1, 2005 and signed by Chris Wiebelhaus. Laboratory Supervisor, addressing the steps you are taking to correct the deviations noted on the FDA 483 - Inspectional Observations issued at the close of the inspection on February 8, 2005. Although the response appears to address many of the deviations observed during the most recent inspection, it fails to address the underlying cause of the chronic deviations at your facility.

Please submit, in writing, within fifteen working days of receiving this letter, your responses to the deviations identified in this letter . Your letter should include a description of the status of the corrective actions outlined in your firm's March 1, 2005 letter and the steps that you are taking to prevent future deviations . Your reply should be sent to Nadine Nanko Johnson, Compliance Officer, at the above address.

 

Sincerely,

/S/

John W. Thorsky
District Director
Kansas City District