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

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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

Type of respondentsNumber of respondentsEstimated number of responses per respondentAverage burden hours per responseEstimated total annual burden hours requested
Donors initially contacted4081.0832.6
PDI Donors* 6010.530
Deferred Donors* 3010.515
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Accepted Donors* 1210.56
Total40883.64
* 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.

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Dated: February 16, 2010.

George Nemo,

NHLBI Project Officer, NHLBI, National Institutes of Health.

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[FR Doc. 2010-3449 Filed 2-22-10; 8:45 am]

BILLING CODE 4140-01-P