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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ochsner Clinic Foundation 29-Aug-07

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

Public Health Service
Food and Drug Administration

 

New Orleans District
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217

Telephone: (615) 366-7801
FAX: (615) 366-7802


August 29, 2007

WARNING LETTER NO. 2007-NOL-14

FEDERAL EXPRESS
OVERNIGHT DELIVERY

Dr. Patrick Quinlin, M.D., CEO
Ochsner Clinic Foundation
1514 Jefferson Highway
New Orleans, Louisiana 70121

Dear Dr. Quinlin:

On June 5, 7, and 11, 2007, United States Food and Drug Administration (FDA) investigators inspected The Fertility Center at Ochsner, located at 1221 South Clearview Parkway, Jefferson, Louisiana. During the inspection, our investigators documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/P's) set forth in Title 21, Code of Federal Regulations, Part 1271 (21 CFR1271), issued under the authority of Section 361 of the Public Health Service Act (the Act), [42 United States Code (USC) 264]. You may find the specific regulations through links in FDA's Internet home page at http://www.fda.gov.

At the close of the inspection, a Form FDA483 (enclosed) was issued to Dr. P. Ronald Clisham, M.D., Section Head, Fertility and Reproductive Services, The Fertility Center. The deviations documented include, but are not limited to, the following:

1. Failure to test a specimen from an anonymous or directed donor of reproductive cells or tissue to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract, including Chlamydia trachomatis and Neisseria gonorrhea [21 CFR 1271.85(c)]. Specifically, two anonymous donors, whose oocytes were transferred to recipients, were not tested for these diseases. On March 26, 2007, 22 oocytes were recovered from donor [redacted] and were fertilized with semen from the recipient' [redacted] spouse. Four resulting embryos were transferred to recipient [redacted] on March 31, 2007. On January 24, 2007, 12 oocytes were recovered from donor [redacted] and were fertilized with semen from anonymous semen donor [redacted]. Three resulting embryos were transferred to recipient [redacted] on January 27, 2007.

2. Failure of a responsible person to determine and document the eligibility of an anonymous or directed donor of reproductive cells or tissue [21 CFR 1271.50(a)]. Specifically, no documentation was found during the review of six anonymous oocyte donor files from 2006 and 2007 [redacted] to substantiate a responsible person, either from your firm or from the oocyte donor organizations, had determined the donors to be eligible for donation. There were no records verifying donor eligibility based on the results of donor screening, in accordance with Section 1271.75, and donor testing in accordance with Sections 1271.80 and 1271.85. Oocytes were recovered from all six donors and were fertilized and transferred as embryos to five recipients or cryopreserved for future use.

3. Failure to screen an anonymous or directed donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)]. Specifically:

a. Records for donor [redacted] did not include documentation of a medical/social history interview, as defined in 21 CFR 1271.3(n), or physical examination. On November 14, 2006, 12 oocytes were retrieved from donor [redacted] and were fertilized with semen from the recipient's [redacted] spouse. On November 19, 2006, two resulting embryos were transferred to recipient [redacted].

b. Records for donor [redacted] did not include documentation of a medical/social history interview, as defined in 21 CFR 1271.3(n), or physical examination. On November 10, 2006, 11 oocytes were retrieved from donor [redacted] and were fertilized with semen from the recipient's [redacted] spouse. On November 15, 2006, the resulting embryos were transferred to recipient [redacted].

c. Records for donor [redacted] did not include documentation of a medical/social history interview, as defined in 21 CFR 1271.3(n) or physical examination. On January 24, 2007, 30 oocytes were retrieved from donor [redacted] and were fertilized with semen from the recipient's [redacted] spouse. At least eight embryos were cryopreserved for future use by recipient [redacted].

d. Records for donor [redacted] did not include a physical examination. On January 24, 2007, 12 oocytes were retrieved from donor [redacted] and were fertilized with semen from anonymous semen donor [redacted]. Three resulting embryos were transferred to recipient [redacted] on January 27, 2007.

e. Records for donor [redacted] did not include complete documentation of a medical/social history interview, as defined in 21 CFR 1271.3(n). A "Donor Medical History Interview Form" was in the donor's record; however, the second page of the form was missing. As a result, there was no documentation related to risk factors for human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease, diseases of the genitourinary tract, and those associated with xenotransplantation. On March 26, 2007, 22 oocytes were retrieved from donor [redacted] and were fertilized with semen from the recipient's [redacted] spouse. On March 31, 2007, four resulting embryos were transferred to recipient [redacted].

4. Failure to collect a donor specimen for testing for relevant communicable diseases within 30 days before oocyte recovery or up to seven days after recovery [21 CFR 1271.80(b)]. Records indicate donor specimens were not collected within the required timeframe for the following donors:

a. A specimen for Donor [redacted] was collected on June 8, 2006; however, oocyte recovery was performed on November 14, 2006.

b. A specimen for Donor [redacted] was collected on October 27, 2006; however, oocyte recovery was performed on January 24, 2007.

c. A specimen for Donor [redacted] was collected on November 21, 2006; however, oocyte recovery was performed on January 24, 2007.

d. A specimen for Donor [redacted] was collected on September 12, 2006; however, oocyte recovery was performed on November 12, 2006.

5. Failure to retain documentation associated with communicable disease testing, donor screening for communicable diseases, and donor eligibility determination for donors of reproductive cells or tissue [21 CFR 1271.55(d)(1) and(3)]. Specifically, the records for anonymous semen donor [redacted] did not contain documentation, including, but not limited to, the following:

a. The results and interpretation of testing for relevant communicable disease agents;

b. The results and interpretation of all donor screening for communicable diseases; and,

c. Donor eligibility determination, including the name of the responsible person who made the determination and the date of the determination.

On January 24, 2007, the semen was used to fertilize 12 oocytes from anonymous oocyte donor [redacted]. Three resulting embryos were transferred to recipient [redacted] on January 27, 2007.

6. Failure to establish and maintain procedures for all steps you perform in testing, screening, determining donor eligibility, and to comply with all other requirements of Subpart C "Donor Eligibility" in 21 CFR 1271. "Establish and maintain" means define, document (in writing or electronically), and implement; then, follow, review, and revise when necessary. Before implementation, a responsible person must review and approve all procedures [21 CFR 1271.47(a) and (b)]. Specifically, your firm had no written procedures addressing donor screening, donor testing, and donor eligibility determinations.

This letter may not list all deviations at your facility. You are responsible for ensuring your firm adheres to all requirements of the Act and regulations applicable to human reproductive HCT/P's.

We acknowledge the new written procedure entitled "Accepting Egg Donors," by Ms. [redacted] Manager, and Dr. Clisham provided on June 7, 2007, to our investigators which was intended as a corrective action for one of the inspectional findings. Our investigators discussed the following deficiencies with Ms. [redacted] and Dr. Clisham:

a. The procedure was not signed or dated by a responsible person to indicate it had been reviewed and approved before implementation;

b. The procedure stated infectious disease testing must be done within 6 months of the retrieval process, which exceeds the regulatory requirement to collect a test specimen within 30 days of oocyte recovery; and,

c. The required communicable disease tests did not include Trepojiemcc pallidzern (i.e., syphilis or Rapid Plasma Reagin test).

On June 11, 2007, your staff provided our investigators with a corrected copy of the procedure. However, the procedure was not signed or dated by a responsible person to indicate it had been reviewed and approved before implementation.

You should take prompt action to correct these deviations and prevent their recurrence. Failure to do so may result in regulatory action without further notice. For example, FDA may issue an order to cease manufacturing HCT/P's.

Please respond in writing within 15 working days of your receipt ofthis letter outlining the specific steps youhave taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations andprevent their recurrence. You should include in your response documentation, such as written procedures andother useful information to assist us in evaluating your corrections. If corrective action cannot be completed within 15 working days, we expect youto explain the reason for the delay and state when the remaining deviations will be corrected.

Please send your reply to the U.S. Food andDrug Administration, Attention: Rebecca A. Asente,Compliance Officer, at the above address. If youhave questions regarding issues in this letter, please contact Ms. Asente at (504) 219-8818, extension 104.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District

Enclosure: Form FDA 483

cc: Dr. P. Ronald Clisham, Section Head
Fertility andReproductive Services
TheFertility Clinic at Ochsner
1221 South Clearview Parkway
Jefferson, Louisiana 70121-2429