| Comment Record|
Dr. Judith Woll ||
2003-04-25 07:28:36 |
Community Blood Center |
Health Professional |
| Comments for FDA General |
1. General Comments
April 24, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, Maryland 20852
To Whom It May Concern:
Community Blood Center/Community Tissue Services (CBC/CTS) would like to comment on the April 2003 Guidance for Industry entitled Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS.
CBC/CTS is a not-for-profit, charitable organization. Headquartered in downtown Dayton, Ohio, CBC also operates four branch blood collection sites in Springfield, Middletown, and Hamilton, Ohio, and Richmond, Indiana. CBC serves the total blood needs of 26 local hospitals in 15 counties throughout the Miami (Ohio) and Whitewater (Indiana) Valleys. CBC delivers blood to all hospitals served and handles emergencies on a seven days per week, twenty-four hours a day basis. The Apheresis department at CBC operates at the Dayton Headquarters and the Springfield branch, and also performs therapeutic procedures at hospitals throughout our service area. Mobile blood drives are scheduled throughout the counties we serve to help assure that donations will be sufficient to meet patient blood needs. CBC is also accredited as a regional Marrow Donor Center, and operates Reference and Stem Cell laboratories accredited by the American Association of Blood Banks (AABB).
CBC/CTS’s Tissue Services (CTS) were founded in Dayton, Ohio in 1986. CTS is now a national network with branches located in Portland, Oregon; Fresno, California; Indianapolis, Indiana; and Ft. Worth, Texas. Currently, CTS distributes more than 30,000 allografts annually, making it one of the largest tissue banks in the United States. As a full service tissue bank, CTS is strongly committed to providing quality tissue for transplantation. Patient safety and physician satisfaction are our priorities. All CTS branches are accredited by the American Association of Tissue Banks. All CTS branches follow the AATB Standards and current FDA regulations.
Our comments on the guidance are as follows:
Issuance Without Comment § The SARS guidance was issued without seeking public comments because, according to FDA, “SARS may pose immediate safety risks to the blood supply”. While it is possible that this risk may be documented in the future, at the time of issuance of the guidance there were 35 cases of SARS (according to the WHO case definition) reported to the CDC.§ FDA could have issued the guidance as a draft or convened an emergency meeting of the Blood Products Advisory Committee in order to have input from the public, including our membership.
Required vs. Recommended § The cover page of the guidance states, “This guidance is being distributed for immediate implementation.” However, the verbiage of the guidance indicates that the entire guidance is simply the recommended process for assessing donor suitability.§ It is not clear whether facilities are required by FDA to implement the guidelines.
Lack of Scientific Basis for Scope of Guidance § The final guidance was issued in the absence of scientific knowledge, when the total number of cases in the US was 35 (about 1/8,000,000 population in the US) with no clinical evidence of transfusion transmission.§ Ninety four percent of those cases were in travelers returning from CDC listed countries. However, the guidance covers the entire scope of issues without regard for the impact that it may have on collecting facilities and volunteer blood donors.§ The guidance should have had a much more limited scope: addressing the potential that a traveler returning from one of the countries listed by CDC may have asymptomatic viremia with the putative SARS agent(s).§ Future guidance or “triggers” for a broader scope could have been built into this guidance based on the evolution of the epidemic.
Tissue Implementation § If the implementation of the guidance’s recommendations are important enough for immediate implementation to ensure the safety of recipients of blood components, the same should hold true for organ, tissue, or hematopoietic stem cell recipients.§ However, the guidance simply suggests that tissue establishments “consider implementing similar donor screening practices.”
Impact on Blood Availability § Since the ultimate spread of SARS is undetermined, it is possible that geographical deferrals will make collections impossible in certain areas of the US, thus creating a supply crisis.§ An alternative is to focus deferrals on individuals that have been classified as SARS contacts by Public Health Authorities.
Impact on Donor Screening § The guidance seriously complicates the already complex donor screening process by imposing three additional donor questions that must be answered at several levels.§ This requires additional donor time, staff time and possibly additional staff, training, revision of donor forms, modification of computer systems, computer validation, etc.
Addition of New Questions § To our knowledge, the AABB Uniform Donor History Questionnaire task force was not involved in the development or analysis of any of the questions nor was any expert in interviewing.§ The new questions were not validated for comprehension.§ We believe that the additional questions could have a negative impact on blood safety, by making the donor history process more complex and confusing, and diverting the attention of donors from real issues like risk behavior.§ It is our experience that the more we ask, the less we learn. Interviewers and donors get tired. Very few people have a span of attention that can keep up with the over 40 questions dealing with over 70 issues that are posed by the interviewer.
Compliance with cGMPs § Implementation of these guidelines in the cGMP environment in less than 30 days is difficult, to say the least.§ Facilities must consider SOP revisions, training, validation, software revisions, and software and systems validation issues.§ There is not clear evidence that the threat of SARS from transfusion justifies the priority it is given by FDA, especially in the face of our attempts to bring up WNV NAT, for a demonstrated risk.§ The alternative is a less controlled implementation of the SARS guidance and resulting defects in the trackability and traceability FDA demands.
Question 1 § “In the past 28 days, have you been ill with SARS or suspected SARS?”§ On the date of issuance of the guidance, CDC reported 1 case per 8 million inhabitants in the US.§ A more appropriate action would be for PHS to advise SARS patients not to donate blood for 28 days. Should the epidemic expand substantially in the US, this can be revisited.§ In addition, these people would have been covered by the travel or contact questions.§ We strongly recommend deletion of this question.
Close Contacts § With the small number of cases in the US, there are very few close contacts.§ We recommend that the question should be implemented only if there are more than a certain number of SARS cases in the US, and evidence of parenteral transmission is forthcoming.
Instruction to Visit CDC Website for Updates § The recommendation that collecting facilities consult the CDC website “routinely and periodically” for updates cannot be implemented in a cGMP environment.§ Changes in the list of countries of the definition of close contacts require changes in SOPs, changes in donor registration forms, changes in information provided to donors before donation, changes in documentation that the questions were asked and the answers were acceptable, training of staff, etc.§ The statement in the guidance implies that consultation of the CDC website must take place almost daily or, if taken to its extreme before each donor interview. For instance, the guidance was issued on Thursday, April 17 and CDC changed its case definition on Friday, April 18, 2003.§ Suggestion – FDA should withdraw this guidance, or issue further updates with ample time for implementation.
Post Donation Information § Collecting facilities are instructed to “actively encourage donors to report, post donation, information about SARS exposure, illness, or treatment that occurs after donation.”§ Currently, our donors take home a “Donor Receipt”. Included on this receipt are instructions to contact CBC if they become ill or become aware of any information that would have deferred them from donation.§ Is this guidance recommending that a specific process be implemented to solicit post donation information from donors related to SARS?
Reporting to Local Health Agencies § The recommendation for reporting of SARS cases in donors or recipients to local health authorities is not reasonable.§ SARS cannot be diagnosed over the telephone by blood center collections staff or physicians.§ It is the obligation of the diagnosing physician to report the case to health authorities, not a collection facility with inadequate information.§ While the collection facility can initiate retrieval of products, it must not be required to assume the responsibility to notify public health authorities based on a telephone conversation with the donor. The same is true for a blood recipient who develops SARS. The responsibility is that of the diagnosing physician. § Blood collecting facilities can and will collaborate with health authorities in the tracing of units, specimens and disposition of products from the index donation.
Notification of Treating Physician § The guidance recommends that “establishments consider notifying the treating physician of those recipients about the post donation information, including whether the donor developed suspected SARS.”§ The recommendation implies that facilities should notify the recipient’s physician. Blood centers notify consignees (Hospital Transfusion Service Medical Directors), who then are responsible for notification of the transfusing physician. Blood centers do not necessarily have access to recipient information, especially since HIPAA implementation.
Summary 1. The current guidance document should be rescinded and replaced by a more reasonable approach.2. We are not convinced by the FDA that the threat of SARS to transfusion safety rises to the level of emergency action required by the Guidance. 3. While evidence on this issue is developed, and the epidemiology in the US is monitored, we propose that a deferral for 14 days for travel to CDC-listed destinations is an adequate initial step that will fit well with current operations and capture more than 90% of current cases in the US. 4. Additionally, the FDA must convince CDC to add a proscription from blood donation to information already being provided to returnees from listed countries, as we have previously and repeatedly suggested as a simple, effective approach to prevent donation by at risk individuals.
Thank you, in advance, for reviewing our comments. Please contact Patty Malone, Quality Assurance Director, at (937) 461-4248, extension 3313, or at firstname.lastname@example.org with any questions.
Judith E. Woll, MD