[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71173-71174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-28863]
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DEPARTMENT OF DEFENSE
Office of the Secretary
[Docket ID DoD-HA-2012-0148]
Proposed Collection; Comment Request
AGENCY: Office of the Assistant Secretary of Defense for Health
Affairs, DoD.
ACTION: Notice.
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In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, the Office of the Assistant Secretary of Defense for
Health Affairs announces the proposed extension of a public information
collection and seeks public comment on the provisions thereof. Comments
are invited on: (a) Whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility; (b) the
accuracy of the agency's estimate of the burden of the proposed
information collection; (c) ways to enhance the quality, utility, and
clarity of the information to be collected; and (d) ways to minimize
the burden of the information collection on respondents, including
through the use of automated collection techniques or other forms of
information technology.
DATES: Consideration will be given to all comments received by January
28, 2013.
ADDRESSES: You may submit comments, identified by docket number and
title, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Federal Docket Management System Office, 4800 Mark
Center Drive, East Tower, 2nd floor, Suite 02G09, Alexandria VA 22350-
3100.
Instructions: All submissions received must include the agency
name, docket number and title for this Federal Register document. The
general policy for comments and other submissions from members of the
public is to make these submissions available for public viewing on the
Internet at http://www.regulations.gov as they are received without
change, including any personal identifiers or contact information.
FOR FURTHER INFORMATION CONTACT: To request more information on this
proposed information collection or to obtain a copy of the proposal and
associated collection instruments, please write to Program Manager,
Defense Health Information Management System (DHIMS), ATTN: COL Aaron
J. Silver, 5109 Leesburg Pike, Skyline 6, Suite 703, Falls Church, VA
22041, or call DHIMS, at (703) 681-7122.
Title; Associated Form; and OMB Number: Enterprise Blood Management
System (EBMS); OMB Control Number 0720-TBD.
Needs And Uses: EBMS is a family of related automated information
systems (AIS) comprised of two separate and distinct commercial-off-
the-shelf (COTS) software applications that provides the Military
Health System (MHS) with a comprehensive enterprise wide Blood Donor
Management System (BDMS) and a Blood Management Blood Bank and
Transfusion Service (BMBB/TS).
The Blood Donor Management System (BDMS) employs two
separate COTS software applications, Mediware Corporation's LifeTrak
DonorTM and LifeTrak Lab & DistributionTM. BDMS
is a technology modernization effort intended to enhance the DoD's
Blood Program capabilities for Donor Centers through the seamless
integration of blood products inventory management, transport,
availability, and most importantly, blood and blood products
traceability from collection to disposition within the electronic
health record (EHR).
The Blood Management Blood Bank Transfusion Service (BMBB/
TS) employs two separate COTS software applications, Mediware
Corporation's
[[Page 71174]]
HCLLTM (Transfusion) and KnowledgeTrakTM
(Learning Management). BMBB/TS is an effort intended to enhance the
DoD's Blood Program capabilities for a seamless integration of blood
banking and transfusion activities, products inventory management,
transport, availability, and most importantly traceability from
transfusion to disposition or destruction within the electronic health
record (EHR).
EBMS has built-in safeguards to limit access and visibility of
personal or sensitive information in accordance with the Privacy Act of
1974. The application will account for everyone that donates blood and
receives a blood transfusion in the MHS--Active Duty, Reserves,
National Guard, government civilian, contractors and volunteers
assigned or borrowed--this also includes non-appropriated fund
employees and foreign nationals.
Affected Public: Contractors, civilian and foreign nationals
donating to the Military Health Systems.
Annual Burden Hours: 766.
Number of Respondents: 4,600.
Responses per Respondent: 1.
Average Burden per Response: 10 minutes.
Frequency: On occasion.
SUPPLEMENTARY INFORMATION:
Summary of Information Collection
In order to attain standardization, ensure a safe blood product,
and comply with Federal law, all Military blood facilities are licensed
and/or registered by the Food and Drug Administration (FDA) and must
operate according to Title 21, Code of Federal Regulations, Part 211,
Current Good Manufacturing Practices for Finished Pharmaceuticals, Part
610 series, Biologics, and Part 820 series, Medical Devices.
The EBMS Mediware Corporation developed COTS are FDA 510K cleared
Medical Devices that provides the Military Health System (MHS) with a
comprehensive enterprise wide Blood Donor Management System (BDMS) and
Blood Management Blood Banking and Transfusion Service (BMBB/TS) with
capabilities to manage blood donors (both in-house and at mobile
collection sites), manage blood products both fresh and frozen
throughout the collection, processing, testing, storing, and shipping
procedures; interface with testing instrumentation for enterprise
(Global) results management; shipping blood with in-transit visibility
and shipping data transmit and receive; automate, enterprise-wide
``lookback'' for donors, patients, and products; automated, blood order
issue, and transfusion records; manage enterprise inventory (Global),
including Theater and VA. It has built-in safeguards to limit access
and visibility of personal or sensitive information in accordance with
the Privacy Act of 1974. The application will account for everyone that
donate blood and receive blood transfusion in the MHS--Active Duty,
Reserves, National Guard, government civilian, contractors and
volunteers assigned or borrowed--this also includes non appropriated
fund employees and foreign nationals.
EBMS is an n-tier enterprise solution. The solution will use COTS
products, installed at a Central Server location. EBMS has
applicability at the headquarters level allowing Armed Services Blood
Program (ASBP) which is delineated in several regulations, including
DoDD 6000.12, DoDI 6480.4, and AR10-64 and Service Blood Program Office
(SBPO) to use this product to conduct its own day-to-day blood
inventory management. This comprehensive tool provides the capability
to manage inventory, monitor adverse trends, review lookback cases,
manage donor deferrals and develop standard operation procedure.
Deciding to implement EBMS within MHS provides an enterprise solution
for transfusion and donor processing that can be applied to enterprise-
wide blood inventory, and traceability throughout patient and donor
life.
The information in EBMS is personal or sensitive; therefore, it
contains built-in safeguards to limit access and visibility of this
information. EBMS uses role-based security so a user sees only the
information for which permission has been granted. It uses state-of-
the-market 128-bit encryption security for our transactions. It is DoD
Information Assurance Certification and Accreditation Process (DIACAP)
certified having been subjected to and passed thorough security testing
and evaluation by independent parties. It meets safeguards specified by
the Privacy Act of 1974 in that it maintains a published Department of
Defense (DoD) Privacy Impact Assessment and System of Record covering
Active Duty Military, Reserve, National Guard, and government civilian
employees, to include non-appropriated fund employees and foreign
nationals, DoD contractors, and volunteers. EBMS is hosted in a secure
facility managed by the MHS Cyber-Infrastructure Services (MCIS).
Dated: November 26, 2012.
Aaron Siegel,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 2012-28863 Filed 11-28-12; 8:45 am]
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