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AABB > Press Room > Comments

Joint Comments to FDA on the Draft Guidance on Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis 

22 May 2013

Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Re: Docket No. FDA–2003–D–0128: Draft Guidance for Industry – Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis, March 2013

Dear Dockets Manager:

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

Founded in 1962, America's Blood Centers is North America's largest network of community-based, independent blood programs. Recognized by the U.S. Congress for its critical work in patient care and disaster preparedness and response, the federation operates more than 600 blood donor centers providing half of the U.S., and a quarter of the Canadian blood supply. These blood centers serve more than 150 million people and provide blood products and services to more than 3,500 hospitals and healthcare facilities across North America. America's Blood Centers' U.S. members are licensed and regulated by the U.S. Food and Drug Administration. Canadian members are regulated by Health Canada.

The American Red Cross shelters, feeds and provides emotional support to victims of disasters; supplies more than 40 percent of the nation's blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. Over six million units of whole blood are collected from nearly four million Red Cross volunteer donors, separated into 9.5 million components, and supplied to approximately 3,000 hospitals and transfusion centers to meet the needs of patients each year.

Thank you for the opportunity to provide input to the development of new recommendations for screening, testing and management of blood donors and blood components based on screening tests for syphilis. The 1991 memorandum predates the existence of assays and technology that are commonly used by today's blood establishments and a new guidance document is an opportunity to address several issues that have arisen in the intervening years.

Comments to specific recommendations in the guidance document are arranged in the following format:

Section – language from the draft guidance is reprinted.
Recommendation or Request for Clarification – recommendation or clarification request.
Rationale/Supporting Information – rationale in support of the recommendation or clarification request.

Section – III. CHARACTERISTICS OF SEROLOGIC ASSAYS FOR SYPHILIS

Recommendation – The list of cleared donor screening tests for Treponema pallidum currently found on the Tissue & Tissue Products web page should be displayed on the Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays found on the Blood & Blood Products web page.

Rationale - The tests that are cleared for use with blood donors should be included on the Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays found on the Blood & Blood Products web page. Furthermore the tissue web page listing includes cleared diagnostic assays and the statement – "At this time, we consider FDA-cleared diagnostic serological tests to be adequate for use in donor screening for syphilis." While the statement may be true for tissue donors it is confusing when the web page is accessed for the purpose of obtaining information on assays for use with blood donor screening.

Request for clarification – The description of treponemal assays includes the statement that a chemiluminescence immunoassay has been cleared by the agency for screening donors. We are not aware of this assay and ask that it be added to the list of cleared donor screening tests for Treponema pallidum or that the guidance be corrected.


The remaining comments are directed to Section IV. RECOMMENDATIONS FOR DONOR TESTING AND MANAGEMENT AND PRODUCT DISPOSITION WHEN USING TESTS FOR SYPHILIS.

Section – A. Identification of Donors with a History of Syphilis

  1. To assess the suitability of the donor as required in 21 CFR 640.3, we recommend that you ask the following question of all donors at each donation:

    "In the past twelve months have you had or been treated for syphilis or gonorrhea?"

Recommendation – Item 1 should be reworded to state "To assess the suitability of the donor as required in 21 CFR 640.3, we recommend that you question the prospective donor to determine if they have or had syphilis or gonorrhea in the past 12 months, including whether they were treated for the diseases during that time." Delete specific wording for a question.

Rationale – Specific wording for a question should not be listed in a guidance document as this could make it difficult to modify the question in the future during updates to the AABB donor history questionnaire.


Section – Footnote 3 on page 6

Request for clarification – The phrase "considered for requalification" is confusing. Please clarify if the intent is to allow the diagnostic test to be used for donor counseling or donor reentry after deferral.


Section – B. Donor Testing and Management When Using a Nontreponemal Screening Test as the Test of Record for the Detection of Syphilis

Product Management and Reentry Under 21 CFR 610.41(b) of Deferred Donors
3.
b.
i. Presents written evidence from a physician or public health clinic of successful treatment of syphilis that was completed at least 12 months prior to the next donation; and

Recommendation – Item i. should be reworded to "Presents written evidence from a physician or public health clinic of completion of treatment for syphilis…prior to the next donation, or that the donor was determined not to have syphilis; and…"

Rationale – Section IV. A. uses "completion of treatment". Evidence of completion of treatment from a physician or public health clinic is sufficient and avoids having blood center staff determine the definition of "successful" treatment.

Some donors are assessed by their physicians and determined not to have syphilis. A reentry process is needed for these donors as they will not present with evidence of successful treatment.


Section – B. Donor Testing and Management When Using a Nontreponemal Screening Test as the Test of Record for the Detection of Syphilis

Product Management and Reentry Under 21 CFR 610.41(b) of Deferred Donors

An acceptable reentry algorithm under 21 CFR 610.41(b) must include the use of a nontreponemal screening test to test the reentered donor's next donation and subsequent donations. The nontreponemal screening test is useful in monitoring a patient's response to antibiotic therapy.

Recommendation – The paragraph should be reworded to state "An acceptable reentry algorithm under 21 CFR 610.41(b) can include the use of a nontreponemal screening test to test the reentered donor's subsequent donations." Delete the last sentence as it is oriented toward patient medical care.

Rationale – There appears to be no medical or scientific reason to require that a nontreponemal test must be used for every donation for these donors and we strongly recommend the wording be changed from must to can. Establishments should have the option of using treponemal tests, since this is the test most likely used in routine donor screening and there is no medical rationale provided for the use of the nontreponemal test if a treponemal test is negative.


Section – C. Donor Testing and Management When Using a Treponemal Screening Test as the Test of Record for the Detection of Syphilis

Reentry Under 21 CFR 610.41(b) of Deferred Donors
3.
b.
i)
A) Presents written evidence from a physician or public health clinic of successful treatment for syphilis completed at least 2 months before the next donation5; and…

Request for clarification – Please clarify the reason for using 2 months at this point in the algorithm as opposed to 12 months used elsewhere. Footnote 5 is an article by Katz but it does not clarify the use of 2 months. It is highly unlikely that a true positive treponemal test will revert to negative in 2 months, and a longer interval (e.g., 12 months) would be more medically appropriate.


Section – C. Donor Testing and Management When Using a Treponemal Screening Test as the Test of Record for the Detection of Syphilis

Reentry Under 21 CFR 610.41(b) of Deferred Donors
3.
b.
i.
A) Presents written evidence from a physician or public health clinic of successful treatment for syphilis completed at least 2 months before the next donation5; and…

ii.
A) Presents written evidence from a physician or public health clinic of successful treatment for syphilis completed at least 12 months before the next donation; and…

Recommendation – Item A. under i. and ii. should be reworded to "Presents written evidence from a physician or public health clinic of completion of treatment for syphilis…before the next donation, or that the donor was determined not to have syphilis; and…"

Rationale – Section IV. A. uses "completion of treatment". Evidence of completion of treatment from a physician or public health clinic is sufficient and avoids having blood center staff determine the definition of "successful" treatment.

Some donors are assessed by their physicians and determined not to have syphilis. A reentry process is needed for these donors as they will not present with evidence of treatment. This is the current situation and redress through guidance is needed.


Section – C. Donor Testing and Management When Using a Treponemal Screening Test as the Test of Record for the Detection of Syphilis

Reentry Under 21 CFR 610.41(b) of Deferred Donors
3.
b.
i) If the nontreponemal screening test result is nonreactive…

An acceptable reentry algorithm under 21 CFR 610.41(b) must include the use of a nontreponemal screening test to test the reentered donor's next donation and subsequent donations.

ii) If the nontreponemal screening test result is repeatedly reactive…

An acceptable reentry algorithm under 21 CFR 610.41(b) must include the use of a nontreponemal screening test to test the reentered donor's next donation and subsequent donations.

Recommendation – The paragraph common to i) and ii) should be reworded to state "An acceptable reentry algorithm under 21 CFR 610.41(b) can include the use of a nontreponemal screening test to test the reentered donor's subsequent donations."

Rationale – There appears to be no medical or scientific reason to require that a nontreponemal test must be used for every donation for these donors and we strongly recommend the wording be changed from must to can. The vast majority of blood establishments have abandoned nontreponemal tests for blood donation screening in favor of high-throughput, automated treponemal testing. Consequently, blood donation testing laboratories no longer have staff who are proficient in blood donation screening using the nontreponemal test as these assays are used primarily in confirmatory algorithms for the purposes of donor counseling. Reversion of the treponemal test of record is medically sufficient to assure the absence of transfusion transmissible infection.

A reentered donor, by definition, has been reentered into the donor pool and should not be diverted to non-routine testing. A requirement to divert the donor at each future donation to non-routine testing would result in deferral of the donor until special testing is performed. Furthermore, it would require creation and use of special computer flags/codes to identify the donor, quarantine the donation, and create a special testing profile for the sample. Large blood establishments and their testing laboratories do not have the capability of modifying the routine test protocol for these donors. The risk of errors is very high and will cause blood collection facilities to refuse reentry to the donors.

We wish to thank the FDA for the opportunity to address these issues. It is our hope that with the submission of these joint comments from our organizations (AABB, American Red Cross, America's Blood Centers) the agency will appreciate the implications of the recommendations as they would be applied to donor screening rooms across the U.S.

Please feel free to contact me at acarrgreer@aabb.org if you have questions concerning these comments.

Sincerely,

M. Allene Carr-Greer
Director, Regulatory Affairs
AABB

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