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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mercy Health System of Kansas, Inc. 18-Jul-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



July 18, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Ref. KAN 2005-13

Jon D. Swope
President/CEO
Mercy Health System of Kansas, Inc.
401 Woodland Hills Blvd .
Ft. Scott, Kansas 66701-8797

Dear Mr. Swope:

During an inspection of your unlicensed hospital blood bank, located at 401 Woodland Hills Blvd, Ft. Scott, Kansas on May 6 through 19, 2005, our investigator documented deviations from Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 351(a)(2)(B)] and the Current Good Manufacturing Practice (CGMP) Regulations for Blood and Blood Components under Title 21, Code of Federal Regulations (CFR), Part 606. The deviations found include, but are not limited to, the following:

Failure to make a thorough investigation of each reported adverse reaction. [21 CFR 606.170(a)]. For example:

An investigation of transfusion reactions, per the SOP "Blood Transfusion Reaction", used by both the Nursing Department and the Blood Bank, is not always performed. This is evidenced by a review of documented Report of Transfusion Reaction forms indicating:

  • Only 4 of approximately 11 qualifying transfusion reactions were investigated by the Blood Bank in 2005.

  • Only 8 of approximately 25 qualifying transfusion reactions were investigated by the Blood Bank in 2004.

  • Only 5 of approximately 32 qualifying transfusion reactions were investigated by the Blood Bank in 2003.

Failure to prepare and maintain written reports of investigations of adverse reactions, to include conclusions and follow up. [21 CFR 606.170(a)] Transfusion reaction investigation reporting does not document follow-up information to the investigation.

Failure to review all records pertinent to a lot or unit before the release or distribution of the lot or unit of final product. [21 CFR 606 .100(c)] Specifically, temperature charts for the blood bank refrigerator and plasma freezer for the week of January 31, 2005 were not reviewed until May 4, 2005, with the exception of one week.

Failure to include a written description of the blood collection procedure in the standard operating procedure (SOP), to include in-process precautions taken to accurately measure the quantity of blood removed from the donor. [21 CFR 606.100(b)(5)] Specifically, the investigator observed the SOP addresses the use of a trip scale, however, the scale actually used is a digital scale (grams) . The SOP contained no calculation for conversion from grams to milliliters, or requirement for labeling the unit with a final volume.

Written standard operating procedures including all steps to be followed in the processing of blood and blood components for homologous transfusion and autologus transfusion are not always followed . [21 CFR 606 .100(b)(10)] Specifically, the SOP's for the blood bank refrigerator and plasma freezer require a quarterly temperature alarm check . From the year 2003 to the time of this inspection, only five temperature alarm checks have been performed.

Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer. [21 CFR 606.65(e)] Specifically, blood bags with an expiration date of August 2004 and venipuncture preparation supplies were observed available and ready for use. These supplies were last used/observed during the most recent autologus whole blood collection occurring in August 2004.

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 Act and 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.

Please notify this office in writing, within 15 working days of receipt of this letter, of what actions you have taken 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.

Your reply should be addressed to Joseph G. Kramer, Compliance Officer, at the above address.

Sincerely,

/s/
John W. Thorsky
District Director
Kansas City District