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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Our Lady of the Lake Hospital, Inc. 07-May-04

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

Public Health Service
Food and Drug Administration

 

New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
FAX: 504-253-4520


May 7, 2004

WARNING LETTER NO. 2004-NOL-26

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Mr. Robert C. Davidge, CEO
Our Lady of the Lake Hospital, Inc.
Blood Bank
5000 Hennessey Boulevard
Baton Rouge, Louisiana 70808

Dear Mr. Davidge:

During an inspection of your hospital blood bank, located at 5000 Hennessey Boulevard, Baton Rouge, Louisiana, on March 30 - April 2, 5 - 8, 2004, our investigator documented deviations from the Current Good Manufacturing Practice (CGMP) regulations for blood and blood components under Title 21, Code of Federal Regulations (CFR), Parts 600-680 (21 CFR 600 - 680). These deviations cause your blood products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the other regulations through links in FDA’s home page at http://www.fda.gov.

The deviations documented were as follows:

1. Your facility failed to perform a thorough investigation and make a record of the conclusions and follow-up of unexplained discrepancies [21 CFR 606.100(c)]. Specifically, for the period March 2003 to March 2004, your facility documented over 800 instances in which the secondary review of donor records detected undocumented or unexplained medical history questions or incomplete medical evaluations. Your facility does not have records to document that the blood /blood components from these donations were quarantined pending determination of donor suitability, any follow-up made to determine the suitability of the donor prior to the release of the units, the date of any follow-up, and the identification of the person(s) who made the follow-up and completed the donor record.

2. Records are not concurrently maintained with the performance of each significant step in the collection and processing of each unit of blood and blood components so that all steps can be clearly traced [21 CFR 606.160(a)(1)]. For Example:

a. On June 25, 2003, your facility accepted a Donor Record, pertaining to unit [redacted] that was submitted to you by the donor via facsimile after the unit was collected on June 24, 2003. The components from this unit (leukoreduced RBCS and recovered plasma) were distributed on June 30, 2003.

b. Facility employees recorded the hemoglobin, temperature, pulse, and blood pressure results onto at least 11 donor records after the donor left the blood collection site. The records were completed following a review by the Blood Donor Services designee.

c. On March 31, 2004, our investigator observed that the Blood Scale/Shaker Quality Control (QC) operations were documented by an employee who did not perform that operation. In addition, the QC performance checks were performed after whole blood was collected from four donors.

d. On March 31, 2004, an employee was observed documenting the blood storage temperature 1.5 hours after the time that was recorded on the Blood Donor Daily QC record.

3. Your facility failed to maintain written standard operating procedures including all steps to be followed in the collection, processing, storage, and distribution of blood and blood components for homologous transfusion, autologous transfusion, and further manufacturing purposes [21 CFR 606.100(b)]. For example:

a. Written procedures do not address the steps that should be taken to determine the suitability of a donor when donor records are not completed at the time of donation.

b. Written procedures for “Whole Blood Collections” instruct employees to let the phlebotomy site stand for [redacted] before performing the phlebotomy when using a 7.5% povidine-iodine scrub and 10% iodophor complex solution. On March 30, 2004, all phlebotomists at two mobile blood drives blotted or wiped away the iodine solution from the venipuncture site prior to phlebotomy.

c. Obsolete versions of the “Blood Donor Daily Quality Control Record” were not removed from use as stated in your written procedure: “Document Change Control”. For example:

i. The Daily QC Record for the BUS/VAN was revised in the months of July 2003, October 2003 and November 2003. The quality control records indicate that the July 2003 version was being used during the months of October 2003, and November 2003.

ii. The Daily QC Record for the IN-HOUSE location was revised in the months of March 2003, July 2003, August 2003, October 2003, and November 2003. The QC records indicate that the March and July 2003 version were being used during the month of December 2003.

4. Your facility failed to assure that equipment performs in the manner for which it was designed [21 CFR 606.60(a)]. Specifically, your facility uses a [redacted] hematology analyzer for quality control testing of platelets and red blood cells. Your facility does not have any validation data to support the current testing of non citrate-anticoagulated blood samples using this machine which is designed for analyzing EDTA-anticoagulated blood samples.

The above deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all blood products distributed by your facility are in compliance with the Act and the CGMP regulations. You should take prompt action to correct these deviations. Your failure to correct these deviations may result in regulatory action being taken by FDA without further notice. Possible actions include seizure and/or injunction.

We are aware that during the inspection, Mr. Kirk G. Wilson, President and COO, made a verbal commitment to correct violations observed at your firm. However, we request that you notify this office in writing, within fifteen (15) working days of receipt of this letter, of specific steps you have taken to correct these deviations, including examples of any documentation such as employee training records, written standard operating procedures, or other records demonstrating corrective action. If you cannot complete corrections within 15 working days, state the reason for the delay and the time period within which corrections will be completed.

Your reply should be directed to Mark W. Rivero, Compliance Officer, at the above address.

Sincerely,

/s/

Patricia K. Schafer
Acting District Director
New Orleans District

Enclosure: Form FDA 483

cc: [redacted], Medical Director
Our Lady of the Lake Hospital, Inc. - Blood Bank
5000 Hennessey Boulevard
Baton Rouge, Louisiana 70808