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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Oregon Health & Science University 6/23/10

   

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

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

June 23, 2010

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 10-25

Joseph E. Robertson, Jr., M.D., M.B.A., President
Oregon Health & Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239-3011

WARNING LETTER

Dear Dr. Robertson:

The Food and Drug Administration conducted an inspection of the Oregon Health & Science University's Special Immunology and Coagulation Laboratory, located at 3181 Southwest Jackson Park Road, Portland, Oregon, on April 20 and 21, 2010, and April 28, 2010. In addition, we conducted an inspection of Pacific Northwest Transplant Bank (PNTB) at Oregon Health & Science University, located at 2611 Southwest 3rd Avenue, Suite 320, Portland, Oregon, from April 28 to May 12, 2010. During the inspection of the Special Immunology and Coagulation Laboratory (SIC), the FDA investigators found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in Title 21, Code of Federal Regulations, Part 1271 (21 CFR 1271), and issued under the authority of Section 361 of the Public Health Service Act (42 USC 264).

The deviations documented on a Form FDA-483 were presented to and discussed with your Administrative Department Director for the Department of Pathology at the conclusion of the April 20 and 21, 2010 inspection. The items of concern include, but are not limited to, the following:

1. Failure to test using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases [21 CFR 1271.80(c)]. For example, five HCT/P donors were tested for the antibody to Hepatitis C virus and six HCT/P donors were tested for the antibody to Hepatitis B core antigen using expired test kits.

a. Between August 3, 2008 and September 3, 2008, the SIC laboratory utilized an (b)(4) Hepatitis B Virus Core Antigen (Recombinant) (b)(4) EIA screening test, which expired on July 29, 2008, for testing of six HCT/P donors. Our inspection PNTB confirmed that the results from this testing were used to make donor eligibility determinations for six donors and HCT/Ps from the donors were distributed.

b. Between February 9, 2010 and February 24, 2010, the SIC laboratory utilized an (b)(4) Hepatitis C Virus Encoded Antigen (Recombinant) EIA screening test, which expired on January 12, 2010, for testing of five HCT/P donors. Our inspection of PNTB confirmed that the results from this testing were used to make donor eligibility determinations for five donors and HCT/Ps from the donors were distributed.

The above identified violations are not intended to be an all-inclusive list It is your responsibility to ensure that your establishment is in compliance with all applicable requirements of the federal regulations. You are responsible for reviewing all of your firm's operations to assure you are in compliance with all applicable FDA regulatory requirements. You should take prompt action without further notice. Failure to do so may result in additional regulatory action. Such action may include, but is not limited to, an order to retain, recall, destroy or cease manufacture of HCT/Ps.

We acknowledge receipt of your letter dated May 6, 2010, describing corrective actions you have taken or intend to take in response to FDA's inspectional observations of your operations. We have completed our review and although some corrective actions have been implemented, your response is inadequate in a number of respects and for the following reasons, does not adequately address our concerns.

Your response to inspectional observation one states that should this situation arise again you will notify the FDA and request a variance to deviate from your standard operating procedures. The regulations in 21 CFR 1271 do not discuss the submission of variance requests to FDA. While 21 CFR 1271.155 states that you may request an exemption from or alternative to any requirement in subpart C or D of 21 CFR 1271, the Director may only grant an exemption or alternative if he or she finds that such action is consistent with the goals of protecting the public health and/or preventing the introduction, transmission, or spread of communicable disease and that 1) the information submitted justifies an exemption and, 2) the proposed alternative satisfies the purpose of the requirement. The use of expired test kits for testing of HCT/P donors for relevant communicable disease agents does not meet the requirements of 21 CFR 1271, nor does it meet the goal of protecting the public health.

You also indicated in your response that should this situation arise again your laboratory would use additional quality control material to perform ongoing validation of the expired test kits and then report the results as preliminary with a recommendation for further testing. We note that the regulations in 21 CFR 1271.80(c) do not allow for validation of expired donor screening test kits. A donor eligibility determination must be made based on the results of testing for relevant communicable disease agents using donor screening tests in accordance with the manufacturer's instructions, which require that reagents and test kit components to be used within their expiry dating.

Finally, you indicated that in addition to the above, the PNTB would be notified if this situation recurred and that specimens would be sent to another laboratory to perform the required tests. We find this portion of the response to be adequate.

We request that you notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted deviations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the timeframe within which the corrections will be completed.

Your response should be sent to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Lisa
Althar at (425) 483-4940.

Sincerely,

/s/

Charles M. Been
District Director

cc: James MacLowry, M.D.
Professor and Vice-Chair, Department of Pathology
Oregon Health & Science University
Mail Code L471
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239-3098

Oregon State Public Health Laboratory
Laboratory Compliance Section
P.O. Box 275
Portland Oregon 97207-0275