0990-0313 2010 NBCUSSupporting Statement July 2010

Supporting Statement for Request for Clearance:

NATIONAL BLOOD COLLECTION AND UTILIZATION SURVEY (NBCUS)

OMB No. (Reinstatement without change of 0990-0313)

Contact Information:

Richard Henry, ML, MPH

Health Scientist Administrator

U.S. Department of Health and Human Services

(Project Officer)

1101 Wootton Parkway

Suite 250

Rockville, MD 20852

(240) 453-8804

[email protected]

July 22, 2010

SUPPORTING STATEMENT

NATIONAL BLOOD COLLECTION AND UTILIZATION SURVEY (NBCUS)

This request is for OMB clearance for a reinstatement without change of the National Blood Collection and Utilization Survey (NBCUS, OMB 0990-0313). The NBCUS is a biennial survey of the blood collection and utilization community to produce reliable and accurate estimates of national and regional collections, utilization and safety of all blood products. The 2011 NBCUS (data from CY2010) is funded by DHHS and performed by AABB, a member owned 501(c)(3) tax exempt organization whose mission is to advance transfusion safety, and promulgate standards for voluntary compliance and education on key issues affecting blood safety. In previous years a similar survey was performed under the auspices of the National Blood Data Resource Center (NBDRC), a private subsidiary of AABB, with private funding. In 2005, 2007, and 2009 the survey was funded by Department of Health and Human Services (DHHS) and performed by AABB. The questionnaire of the 2011 NBCUS is not significantly different from previous 2007 and 2009 versions of the survey and is being submitted to the OMB as a PRA renewal due to expiration (OMB 0990-0313).

In addition to generating national estimates of collection and utilization, the 2011 survey, as with the previous 2 iterations in 2007 and 2009, includes questions to specifically identify and collect baseline data to support efforts towards a real-time biovigilance transfusion safety monitoring system. The NBCUS also has sections on bacterial testing and human tissue transplantation that are of interest to the transfusion medicine community.

The survey questionnaire will be mailed to approximately 3,000 institutions that include hospitals, blood collection facilities, and cord blood banks selected from the American Hospital Association (AHA) annual survey database and AABB member list of blood collection facilities. The survey includes a core of standard questions on blood collection, processing, and utilization practices to allow for comparison with data from previous surveys; additionally, questions to specifically address emerging and developing issues and technologies in blood collection and utilization are included. Biovigilance is a key theme for the 2011 survey, as continued from the 2007 and 2009 iterations. To that end, questions on transfusion transmitted infections, transfusion associated circulatory overload, acute hemolysis, delayed hemolysis, and severe allergic reactions are included in the survey.

1. Justification

A1. Circumstances Making the Collection of Information Necessary

Under the authority of Section 301 of the Public Health Service Act (42 U.S.C.241), as identified in the 1997 HHS Blood Action Plan, and twice in the Advisory Committee on Blood Safety and Availability’s (ACBSA) recommendations to the Secretary, there is a need to provide national policy makers with current supply and demand data. The ACBSA was established by HHS in 1997 to provide policy advice to the Secretary and the Assistant Secretary for Health. The advice of the committee is partly dependent on the analysis of relevant blood collection and utilization data which is also widely distributed to and used by the transfusion medicine community. To that end, the Office of Public Health and Science (OPHS) is responsible for conducting a biennial cross-sectional national blood products survey. Previous private and government financed versions of the NBCUS have successfully surveyed greater than 90% of the U.S. blood collection and processing facilities and more than 2,900 hospital-based transfusion blood banks in the United States.

As stated in the evolving National Strategic Plan for Blood, the federal government is charged with developing a blood safety public health monitoring system. The identification and collection of biovigilance data in the 2011 NBCUS will help the government by providing specific data to assist in the implementation of this safety monitoring system.

A2. Purpose and Use of Information Collection

The objective of the NBCUS is to produce reliable and accurate estimates of national and regional collections, utilization, and safety of all blood products – red blood cells, fresh frozen plasma, and platelets, as well as related cellular therapy products. This survey will significantly improve the federal government’s capacity to understand the dynamics of blood supply, safety and availability, and to provide a quantitative basis for assessing strategic and regulatory agendas. An important purpose of the 2011 survey is to help the federal government continue to monitor trends in blood availability since a variety of factors have come to play that have reduced the number of people eligible to give blood and, as stated in the evolving National Strategic Plan for Blood, this information is critical to ensure an adequate supply of safe blood in the United States. In addition to use by the federal government, data collected in this survey will be of practical use to the blood banking and hospital transfusion services communities. In previous years the comprehensive survey report published on blood collection and transfusion related activities has been widely used by the transfusion medicine community. Broad dissemination of the survey findings through publication of this survey report and scientific papers in peer reviewed journals has significantly benefited not only HHS, but the transfusion medicine community at large by furthering community discussion of key findings. Data from the 1997 and 1999 surveys have been used in testimony before congress. Data from the 2005 NBCUS was used extensively in the preparation of the Transfusion and Transplantation Safety document by DHHS. Additionally the 2005 and 2007 survey provided baseline information for establishing the Blood Availability and Safety Inventory System (BASIS).

Each question in the proposed survey relates to the analysis objectives detailed in Section A 16 and lists the questions by survey domains and provides justification. The general categories of information to be collected are:

• General information

• Blood collection, processing and testing

• Blood transfusion

• Bacterial testing

• Special procedures and product disposition

• Cellular therapy products

• Human tissue

A3. Use of Improved Information Technology and Burden Reduction

Record-keeping systems of blood banks and hospitals are too diverse to support electronic response to the NBCUS. This survey is envisioned as an electronic questionnaire with an optional paper questionnaire for those facilities not desiring to complete an electronic version. Efforts made to minimize respondent burden are as follows:

• The questionnaire is divided into color coded sections that clearly identify sections that blood banks/ hospitals/cord blood banks need to complete or skip.

• Appropriate sections of the survey instrument will be emailed and/or mailed to each institution.

• The questionnaire contains easy to read instructions and skip patterns to avoid having respondents answer unnecessary questions.

• The questionnaire contains a glossary of definitions to assist the respondent.

To ensure that the most relevant supply and utilization issues are addressed fully, critical questions from the full survey instrument will be available in the form of a supplemental web survey on the AABB website. Institutions either unwilling or unable to participate in the full survey will be asked to respond to this short list of questions.

A4. Efforts to Identify Duplication and Use of Similar Information

Reliable data on blood collection and utilization on a national scale are not available from any other source. While segments of the blood collection industry collect some information, it is often proprietary and not available to the government or the public at large. The 2011 survey will contain the core questions asked on previous national surveys (NBCUS) to allow for comparison of data. In addition, it will also include questions to identify and collect baseline data to support efforts towards establishing a real-time biovigilance blood safety monitoring system. AABB consulted with its various expert committees, consisting of members who are leading researchers in the field, to identify and develop novel questions that are of interest to the transfusion medicine community.

A5. Impact on Small Businesses or Other Small Entities

Very few of the survey respondents are small hospitals. Hospitals performing less than 100 surgeries are excluded from the sample because they contribute little to either collections or blood product utilization. Nevertheless, to help all institutions complete the survey, a 24 hour toll-free helpline will be provided to answer questions related to the survey.

A6. Consequences of Collecting Information Less Frequently

The NBCUS is administered bi-annually. The rapidly changing environment in blood supply and demand makes it important to have regular, periodic data describing the state of US blood collections and transfusions, for understanding the dynamics of blood safety and availability. These data have become even more crucial with the need to help insure patient safety by monitoring and identifying errors in transfusion medicine and related therapies.

A7. Special Circumstances Relating to Guidelines of 5CFR 1320.5

The proposed data collection is consistent with 5CFR 1320.5. There are no special circumstances applicable to the survey.

A8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

As required by 5 CFR 1320.8(d), the 60-day Federal Register notice was published on April 30, 2010, Vol. 75, pp 22806. No comments were received in response to this notice. There have been several meetings outside of DHHS to conceptualize and design sections of this survey. Various AABB expert committees such as the Transfusion Transmittable Diseases Committee, the Intra-organizational Task Force on Biovigilance: Working Group, the Tissue Committee, the Cellular Therapies Committee and the Coding and Reimbursement Committee were consulted in the development of the questionnaire. In addition, experts from the Centers for Medicare & Medicaid Services (CMS), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Centers for Disease Control (CDC) and the Health Resources and Services Administration (HRSA) were consulted on relevant sections of the questionnaire.

A9. Explanation of Any Payment or Gifts to Respondents

Respondents will not receive any gifts or payments.

A10. Assurance of Confidentiality Provided to Respondents

The Privacy Act does not apply to the proposed data collection since respondents are not human subjects, but institutions; and no patient/donor identifiers are collected.

A11. Justification of Sensitive Questions

Information on issues of a sensitive nature involving persons is not being sought. Infectious disease testing results are reported in aggregate only.

A12. Estimates of Annualized Burden Hours and Cost

The burden for the NBCUS survey is summarized in the table below. Each institution that is asked to complete the survey questionnaire is considered to be a respondent. The respondents to this survey are hospitals, blood collection centers and cord blood banks. The number of eligible respondents is 3,000. It is estimated that each respondent will spend about 180 minutes (3 burden hours total; or 1 burden hour/year) completing the questionnaire. Averaged over a period of three years when this OMB clearance will expire, each respondent will spend 60 minutes (1 burden hour) annually to complete this survey. The hourly burden estimates are based on previous years’ experience administering the survey.

Estimate Annualized Burden Table

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
Hospitals, blood collection centers, cord blood banks	3,000	1	1	3,000

Burden Cost

The average annualized response burden cost to respondents is estimated to be $ 96,000 based on an hourly wage of $32 per hour. The hourly wage estimate is based on the Bureau of Labor Statistics’ National Compensation Survey mean hourly wage data for health related occupations in 2005.

Table A12 - 2: Annualized Cost to Respondents
Type of respondents	Total annual response burden hours	Hourly wage rate	Respondent cost
Hospitals, blood collection centers, cord blood banks	3,000	$32.00	$96,000

A13. Estimates of Other Total Annual Cost Burden to Respondents and Record keepers

There is no other capital or start up costs, and no maintenance or service cost components to report.

A14. Annualized Cost to the Federal Government

All survey operations including survey development, data collection, analysis, and preparation of the final report are contracted to the AABB by the government. The total cost of this fixed price contract is $ 655,856. The annualized cost to the federal government is $ 218,619.

A15. Explanation for Program Changes or Adjustments

This collection is being submitted for OMB approval for renewal; only very slight changes were made to some of the survey questions to facilitate usability and all other aspects of the program remain the same; due to an error in the calculation of the previous collection the burden hours decrease by 6,000.

A16. Plans for Tabulation and Publication and Project Time Schedule

The time table for key activities for the 2011 survey is as follows:

Table A 16: Timeline
8/22/2010	Receive OMB clearance
1/05/2011	Begin data collection for 2011 survey (collect CY 2010 data)
4/15/2011	End data collection
4/30/2011	close out
5/30/2011	End data processing and create dataset
5/10/2011	Begin data analysis
10/15/2011	Publish final comprehensive report

Statistical tabulations of results for each question will be presented. These will be broken down by institution type, services provided, USPHS region, etc. Selected examples of types of analyses proposed include:

• Analyses of trends in the U.S. blood supply

• Total supply of blood collected in the U.S. broken down by type (Whole blood, Allogeneic, Whole blood autologous, WB directed, RBC apheresis, platelets, plasma etc)

• Total transfusions in the U.S. broken down by type (Whole blood, RBC, platelets, Non-RBC components transfused etc)

• National estimates of all whole blood and blood component units outdated by blood centers and hospitals

• Component modifications – Irradiation, leukocyte reduction by blood centers and hospitals

• Number of repeat reactive and confirmed positive first time and repeat allogeneic donors by infectious disease marker type

• Rates of confirmed positives and false positives by bacterial testing methods

• Number of adverse events (TRALI, TACO, Hemolysis, Allergic reactions etc)

• Number and type of cellular therapy products collected, processed and infused

• Number of human tissue implants/grafts collected

• Number and type of tissue related adverse events

• Departments responsible for human tissue collection

After final validation of results a comprehensive report of findings from the survey will be published. The 2007 Nationwide Blood Collection and Utilization report is available at www.hhs.gov/bloodsafety and a similar report will be published at the completion of the 2009 NBCUS survey.

A17. Reason(s) Display of OMB Expiration Date is Inappropriate

Expiration date display exemption is not requested. The OMB clearance number and expiration date will be displayed on the upper right hand corner of the survey.

A18. Exceptions to Certification of Paperwork Reduction Act Submissions

The data encompassed by this survey will fully comply with all guidelines of 5 CFR 1320.9 and no exception is requested to certification for Paperwork Reduction Act Submission.

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