Notice: Proposed Collection; Comment Request; Investigating the Causes of 
Post Donation Information (PDI): Errors in the Donor Screening Process

Federal Register: February 23, 2010 (Volume 75, Number 35)             
                  Page 8080-8081

Agency:  DEPARTMENT OF HEALTH AND HUMAN SERVICES
         National Institutes of Health


SUMMARY: In compliance with the requirement of Section 3506(c) (2) (A) 
of the Paperwork Reduction Act of 1995, for opportunity for public 
comment on proposed data collection projects, the National Heart, Lung, 
and Blood Institute (NHLBI), the National Institutes of Health (NIH), 
will publish periodic summaries of proposed projects to the Office of 
Management and Budget (OMB) for review and approval.
    Proposed Collection: Title: Investigating the causes of post 
donation information (PDI): Errors in the donor screening process. Type 
of Information Collection Request: NEW. Need and Use of Information 
Collection: Blood centers are required to use a health history 
screening questionnaire to obtain eligibility information for the 
protection of the donor and recipient prior to blood donation. However, 
the health history process is known to be error-prone and the reasons 
for those errors are largely unknown and untested. Donors often fail to 
report a risk that would have resulted in deferral. This deferral risk 
may be disclosed at a subsequent donation and is classified as Post 
Donation Information (PDI). While this deferral risk may be at the next 
donation event, many examples of PDI are not disclosed nor discovered 
until several intervening donation events have occurred. The reasons 
why donors fail to disclose a deferrable history at the time of one 
donation but subsequently disclose this information at a later time are 
unidentified. This protocol is designed to ascertain why PDI error 
events occur. It will be the first study of any kind to address the 
issue of PDI errors in any systematic fashion. By conducting interviews 
with donors involved in PDI errors, we will gain important qualitative 
knowledge about this problem. Information gathered from these 
interviews will not only elucidate the issue of PDI but will provide 
insight into donor understanding of the screening process and their 
feelings about the process and blood donation in general.
    The main objectives of the study are:
    1. To explore reasons behind errors in the donor screening process 
when donors initially fail to disclose an accurate and complete health 
history.
    2. To explore PDI donors' knowledge, attitudes, behaviors and 
beliefs (KABB) about the health history questionnaire and their 
experience with the screening process and the center.
    3. To compare KABB in PDI donors to deferred (but not PDI) donors 
and accepted donors.
    The study sample will consist of three donor groups:
    1. Donors with a PDI: all identified donors of interest with an FDA 
reportable donor suitability error classified as PDI at the REDS-II 
centers
    2. Deferred donors: appropriately deferred (but not PDI deferred 
donors) at the REDS-II centers
    3. Accepted Donors: appropriately accepted for donation at the 
REDS-II centers
    Telephone interviews will be conducted with consented donors to 
collect information regarding their knowledge, attitudes, behaviors and 
beliefs about the donor health history process. Even though the 
interviews with the donors will be individual, we would like to form 
groups of similar PDI and deferred donors for analysis purposes.
    The five groups of interest include PDI occurrences or deferrals 
that are due to

 Travel (malaria, vCJD)
 Medical (history of diseases including jaundice/hepatitis, 
surgery and medications needed to treat disease including Tegison, 
Proscar and Accutane)
 Blood/Disease Exposure (tattoo, piercings, accidental needle 
stick)
 High Risk Behavior--Sexual (MSM, sex with IV drug-user or 
test-positive individual)
 High Risk Behavior--Non-Sexual (IV drug use, non-sexual 
exposure to Hepatitis C or Hepatitis B.

    All interviews will be digitally-recorded and the recordings 
uploaded onto computers as dss files; these files will be transcribed 
and then coupled to the interviewer notes to form an analytic package 
for the data analysts. Once the interview is conducted successfully, 
each study donor will be mailed a check of $25 as an incentive for 
participating in the study.
    The cognitive testing of the interview guide will be conducted at 
the Hoxworth Blood Center and at the Coordinating Center. For this 
purpose, the blood center staff will identify 2 PDI and 2 deferred 
donors from the five broad categories of interest. They will also 
contact 2 accepted donors for study consent and interview. These donors 
will be approached and consented by following the same procedures that 
will be used for the actual study.
    The data from the semi-structured interviews will be analyzed in 
two ways. The close-ended responses will be analyzed quantitatively. 
This will likely take the form of 3-way cross-tabulations of frequency 
distributions in responses to key questions. The open-ended responses 
will be analyzed as qualitative data. All analytic steps and 
assumptions that led up to the conclusions, including competing 
interpretations of the data, will be fully discussed in the final 
report.
    Frequency of Response: Once. Affected Public: Individuals. Type of 
Respondents: Adult blood donors. The annual reporting burden is a 
follows: Estimated Number of Respondents: 408; Estimated Number of 
Responses per Respondent: 1; Average Burden of Hours per Response: 0.08 
for the initial phone call and 0.5 for responding to the actual 
interview; and Estimated Total Annual Burden Hours Requested: 83.64. 
The annualized cost to respondents is estimated at: $1505.52 (based on 
$18 per hour). There are no Capital Costs to report. There are no 
Operating or Maintenance Costs to report.

Table 1: Estimate of Requested Burden Hours and Dollar Value of Burden 
Hours

                                      Table A.12-1 Estimates of Hour Burden
----------------------------------------------------------------------------------------------------------------
                                                          Estimated number    Average burden    Estimated total
          Type of respondents               Number of     of responses per      hours per        annual burden
                                           respondents       respondent          response       hours requested
----------------------------------------------------------------------------------------------------------------
Donors initially contacted............               408                 1                .08              32.6
PDI Donors............................              * 60                 1               0.5               30
Deferred Donors.......................              * 30                 1               0.5               15

[[Page 8081]]


Accepted Donors.......................              * 12                 1               0.5                6
                                       -------------------------------------------------------------------------
    Total.............................               408  ................  .................              83.64
----------------------------------------------------------------------------------------------------------------
* These respondents are a subgroup of total 408 donors who will be initially contacted to participate in the
  study.

    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) Evaluate the accuracy of the agency's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) Minimize the burden of the collection of information on those who 
are to respond, including the use of appropriate automated, electronic, 
mechanical, or other technological collection techniques or other forms 
of information technology.
    For Further Information Contact: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Dr. George Nemo, Project Officer, NHLBI, Two 
Rockledge Center, Room 9144, 6701 Rockledge Drive, Bethesda, MD 20892-
7950, or call 301-435-0075, or E-mail your request to nemog@nih.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: February 16, 2010.
George Nemo,
NHLBI Project Officer, NHLBI, National Institutes of Health.
[FR Doc. 2010-3449 Filed 2-22-10; 8:45 am]
BILLING CODE 4140-01-P