The FDA conducted an inspection of the New Hope Fertility Center located in New York City from August 26, 2014, through September 15, 2014. During the inspection, an FDA investigator documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) set forth in 21 CFR § 1271, and issued under the authority of Section 361 of the Public Health Service Act (42 USCA 264).
The deviations documented on the List of Inspectional Observations, were presented to and discussed with the Medical Director and Tissue Bank Director of the New Hope Fertility Center at the conclusion of the inspection. These items of concern include, but are not limited to, the following.
The facility failed to test a specimen from the donor of cells or tissue for evidence of infection due to communicable disease agents in order to adequately and appropriately reduce the risk of transmission. For example, the donor specimen collected from anonymous oocyte donor on March 27, 2014, was not tested for the antibody to Hepatitis B core antigen; human immunodeficiency virus, type 1 (HIV-1); and hepatitis C virus (HCV) by the nucleic acid test (NAT) method. Despite the missing test results, the donor was determined eligible and oocytes were recovered on April 20, 2014.
The facility failed to determine as ineligible a donor who was identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required. For example, and anonymous oocyte donor tested positive for Chlamydia trachomatis on August 15, 2013. The donor returned on October 11, 2013, and was retested for Chlamydia trachomatis and the results were negative. A note in the donor’s record documented that the donor was treated with antibiotics. The donor was subsequently determined eligible and oocytes were recovered on November 20, 2013. In another example, on a Donor Medical History Interview Questionnaire date July 28, 2014, an anonymous oocyte donor answered “yes” to the health history questions, “Since 1980, have you ever lived in or traveled to Europe?” and “Since 1980 have you spent time that adds up to 5 years or more in Europe (including time spent in the U.K. between 1980 and 1996)?” A note on the donor’s record indicated that the donor came to the U.S. from Europe in August 2013. Despite the donor’s risk factor for human transmissible spongiform encephalopathy, including variant Creutzfeldt-Jakob disease (vCJD), the donor was determined eligible and oocytes were recovered on July 30, 2014.
The facility failed to collect donor specimens for testing for relevant communicable diseases at the time of recovery of the cells or tissue from the donor; or for oocyte donors, within 30 days prior to oocyte recovery or up to seven days after recovery. For example, the specimen from an anonymous oocyte donor was collected on October 22, 2012. However, oocytes were recovered from the donor on December 18, 2012. In another example, the specimen from anonymous oocyte donor was collected on August 16, 2013. However, oocytes were recovered from donor on September 24, 2013.
The facility failed to maintain documentation of the results and interpretation of all donor screening for communicable diseases in compliance with regulations. For example, the documentation of the physical examination for at least six donors was incomplete. Specifically, documentation of the screening of the donor for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases was missing.
The facility failed to maintain documentation of the donor-eligibility determination, including the name of the responsible person who made the determination and the date of the determination. The records for multiple donors contained either an Initial Donor Eligibility Determination form or Repeat Donor Eligibility Determination form. However, one or more of the following items was missing from the forms: 1) documentation that the donor was determined “eligible;” 2) the name of the responsible person who made the determination; and 3) the date of the determination.
The facility failed to establish and maintain procedures for all steps performed in the testing, screening, determining donor eligibility, and complying with all other requirements. “Establish and maintain” means define, document, and implement; then follow, review, and as needed, revise on an ongoing basis. Specifically, the facility’s procedure, Modalities for the Rejection of Anonymous Donors, was not in compliance with the requirements of 21 CFR 1271. For example, the section entitled “Laboratory Tests, 3. Hepatitis Profile” stated, “For a donor to remain in the program, both the HBcAb and the HBsAg must be found to be negative. Donors testing HBsAb(+), HBcAb(+), HBsAg(-) have had prior exposure to the virus and are not infectious. It is perfectly safe to use these donors.” Under 21 CFR 1271.80(d), the facility must determine to be ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent in accordance with Sec. 1271.85. This includes a reactive screening test for the antibody to Hepatitis B core antigen (HBcAb). In another example, the section entitled “Laboratory Tests, 3. Hepatitis Profile” stated, “A donor will be excluded from the program if HBcAb is positive in conjunction with a negative HBsAg and negative HBsAb. They may be in the window of seroconversion and should not be used and should be retested in 1 to 2 months.” Under current regulations a facility must determine to be ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent in accordance with Sec. 1271.85. This includes a reactive screening test for the antibody to Hepatitis B core antigen (HBcAb). In another example, the section entitled “Laboratory Tests, 4. HIV Tests” stated, “A seropositive test with a confirmatory Western Blot test will permanently exclude an individual from becoming a donor.” Under 21 CFR 1271.80(d), facilities must determine to be ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent in accordance with Sec. 1271.85. This includes a reactive screening test for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2).
New Hope Fertility Center responded to the FDA’s inspectional observations and outlined corrective actions. The FDA determined that the response was inadequate to address its concerns. Specifically, the response outlined changes to New Hope Fertility Center’s donor testing and screening procedures, including implementation of revised forms. However, the response addressed only prospective changes to New Hope Fertility Center’s practices and did not address the inadequacy of donor screening and relevant communicable disease testing for previous HCT/P donors. Plans to review previous donor records to determine whether additional violations exist were not discussed.
In addition, not addressed was the increased risk of communicable disease transmission for HCT/Ps remaining in storage at New Hope Fertility Center. Regarding donors whose eligibility determination was not performed according to the requirements of 21 CFR 1271.50, the use of HCT/Ps from these donors would not comply with 21 CFR 1271. In order to utilize such HCT/Ps, New Hope Fertility Center must submit to the FDA a request for an exemption from a requirement in 21 CFR 1271, Subpart C including supporting documentation to show how New Hope Fertility Center will mitigate the risks of communicable disease transmission to the recipient(s), in accordance with 21 CFR 1271.155.
See the FDA Warning Letter
See also FDA 2014 Warning Letters
See also Medical Law Perspectives, September 2014 Report: Hepatitis: Provider Malpractice and Patient Injury
See also Medical Law Perspectives, March 2014 Report: Blood Draws, Testing, Transfusions: Venipuncture Injury, Inaccurate Results, Tainted Blood - The Liability Risks
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?