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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Siouxland Community Blood Bank 23-Dec-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 80th Street
Lenexa, Kansas 66214-3340
Telephone: (913) 752-2100



December 23, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

Ref. KAN 2006-09

Janette E. Twait
Chief Executive Officer
Siouxland Community Blood Bank
1019 Jones Street
Sioux City, Iowa 51105-1751

Dear Ms. Twait :


During an inspection of your licensed blood bank, located at 1019 Jones Street, Sioux City, Iowa on October 17 through 28, 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 maintain donor identification throughout donation process [21 CFR 606.160(c)], specifically, questionable unit number traceability and data entry into wrong donor record. For example,

On 3/18/2005 a phlebotomist started the collection of double red cell unit, affixing unit #1988781 to [redacted] donor record . The same phlebotomist started donor [redacted] whole blood collection using collection bag unit #1989200, without affixing a unit # to [redacted] donor record. The unit label was affixed to [redacted] donor record after the discrepancy was noted . At the end of both procedures, the phlebotomist had both units at the same work station and discovered , donor record had no unit #; in an attempt to correct the error, the phlebotomist removed the wrong unit # (1988781) and placed it on [redacted] donor record. Ultimately, the two donors' records had the same unit #1988781. The whole blood unit #1989200 was discarded and the double red cell unit #1988781 was distributed.

On 6/14/2005 double red cell collections were started at the same time. Donor [redacted] sat in a chair, a phlebotomist affixed unit #2002892 to his donor record. Another phlebotomist came to assist and, while [redacted] was in the restroom, put [redacted] donor card at a different station in order to start the collection process on [redacted] in [redacted] original chair. All of [redacted] paperwork was then labeled as unit #2002892. [redacted] returned from the restroom, sat in a different chair, and the phlebotomist started [redacted] collection. At the end of both procedures [redacted] and [redacted] had the same unit #2002892 on their donor records. When the donor records were returned from the mobile, unit # 2002893 was affixed to [redacted] donor record. Management decided to distribute both units 2002892 and 2002893.

  • On four occasions Data Entry Staff entered donor information into the wrong donor record:

  • On 5/16/2005 donor [redacted] (SafeTrace ID#1000028559) donated whole blood unit #1997245; this donor's information was entered into donor [redacted] (SafeTrace
    ID#1000028599) donor computer record.

  • On 5/17/2005 donor [redacted] (SafeTrace ID#309585) donated (TWO DBL RBC'S) unit #1999170; this donor's information was entered into donor [redacted] (SafeTrace
    ID#309858) donor computer record.

  • On 6/7/2005 donor [redacted] (SafeTrace ID#1000029359) donated whole blood unit #1999290; this donor's information was entered into donor [redacted] (SafeTrace
    ID#1000029353) donor computer record.

  • On 7/1/2005 donor [redacted] (SafeTrace ID#1000054050) donated whole blood unit #2004587, this donor's information was entered into donor [redacted] (SafeTrace ID#107639) donor computer record.

Failure to follow written SOP's in the processing of blood and blood components [21 CFR 606.100(b)]. Specifically,

Donors remain eligible (not deferred), in spite of having experienced a severe reaction.

  • On 5/20/2005 whole blood donor [redacted] (unit #1996575) experienced a severe reaction documented as Convulsions and Tetany. To date, the donor's status is "no deferral".

  • On 5/26/2005 whole blood donor [redacted] (unit #1999881) experienced a severe reaction (Convulsions) and a moderate reaction (Unconsciousness). To date, the donor's status is "no deferral".

The SOP #: 1002.6 Medical Conditions states "Convulsions : Acceptable as long as well controlled with or without medication (check Drug Manual). Well controlled is defined as seizure-free in the past year." The firm's SOP does not distinguish between convulsions resulting from medical conditions and convulsions experienced as the result of a donor reaction.

When donors experienced a second phlebotomy, employees failed to affix a second unit number to the donors record at the time of donation. Someone other than the phlebotomist who performed the collection procedure later affixed a unit number.

  • On 5/21/2005 donor [redacted] first phlebotomy was labeled unit #1998089. When the first phlebotomy failed, the employee did not update the record by voiding the first unit # and affixing a second unit #. A second phlebotomy unit #1998090 was affixed 5/22/2005 upon discovery.

  • On 12/30/2004 donor [redacted] first phlebotomy was labeled unit #1979450 . When the first phlebotomy failed, the employee did not update the record by voiding the first unit # and affixing a second unit #. A second phlebotomy unit #1979062 was affixed 12/30/2004 by the QA director.

The SOP 1003.5 states, for non pre-labeled collection sets: "Before starting the phlebotomy, attach the identically numbered labels to : Donor Medical History card", and states for prelabeled collection sets, "Attach number from back of bag to Donor Medical History card."

Failure to submit a Biological Product Deviation Report (BPDR) within 45 days [21 CFR 606.171]. Specifically,

  • BPDR 2005-007 discovered 1/18/2005 was reported 8/16/2005.

  • BPDR 2005-006 discovered 12/14/2004 was reported 8/16/2005.

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. We acknowledge your written response dated November 14, 2005, to the Form FDA 483, List of Inspectional Observations.

Although your response promises revisions to several SOPs, we have not received any additional correspondence from your firm showing that you have completed those SOP updates. In addition, you must adequately implement and maintain each corrective action to ensure its effectiveness. We will verify the adequacy of your corrective actions during our next inspection . Finally, we offer the following suggestion for your consideration in data entry audits . At your option, you may wish to use duplicate donor search criteria during performance of your data entry audit checklist.

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

Sincerely,

/s/
C.R. Pendleton for John W. Thorsky
District Director
Kansas City District