Proposed Data Collections Submitted for Public Comment and Recommendations, 67457-67458 [2011-28218]
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Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
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• Near misses or close calls—patient
safety events that did not reach the
patient, and
• Unsafe conditions—circumstances
that increase the probability of a patient
safety event.
The Common Formats include two
general types of formats, generic and
event-specific. The generic Common
Formats pertain to all patient safety
concerns. The three generic formats are:
Healthcare Event Reporting Form,
Patient Information Form, and Summary
of Initial Report. The event-specific
Common Formats pertain to frequentlyoccurring and/or serious patient safety
events. When used as designed, the
Common Formats allow collection of
information on all harms to patients:
‘‘All-cause harm.’’
The VTE format includes a
description of the patient safety events
to be reported (event description), and
a sample patient safety aggregate report.
The Venous Thromboembolism (VTE)
Common Format is available at the PSO
Privacy Protection Center (PPC) Web
site: https://www.psoppc.org/web/
patientsafety.
Commenting on Venous
Thromboembolism (VTE) Common
Format
To allow for greater participation by
the private sector in the subsequent
development of the Common Formats,
AHRQ engaged the National Quality
Forum (NQF), a non-profit organization
focused on health care quality, to solicit
comments and advice to guide the
further refinement of the Common
Formats. The NQF began this process
with feedback on AHRQ’s 0.1 Beta
release of the Common Formats in 2008.
Based upon the expert panel’s feedback,
AHRQ, in conjunction with an
interagency Federal Patient Safety Work
Group (PSWG), revises and refines the
Common Formats.
The Agency is specifically interested
in obtaining feedback from both the
private and public sectors on this new
beta VTE format to guide their
improvement. Information on how to
comment and provide feedback on the
Common Formats, including the Venous
Thromboembolism (VTE) beta version,
is available at the National Quality
Forum (NQF) Web site for Common
Formats: https://www.Quality.forum.org/
projects/commonformats.aspx.
Common Formats Development
In anticipation of the need for
Common Formats, AHRQ began their
development in 2005 by creating an
inventory of functioning private and
public sector patient safety reporting
systems. This inventory provides an
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evidence base that informs construction
of the Common Formats. The inventory
includes systems from the private
sector, including prominent academic
settings, hospital systems, and
international reporting systems (e.g., the
United Kingdom and the
Commonwealth of Australia). In
addition, virtually all major Federal
patient safety reporting systems are
included, such as those from the Centers
for Disease Control and Prevention
(CDC), the Food and Drug
Administration (FDA), the Department
of Defense (DoD), and the Department of
Veterans Affairs (VA).
Since February 2005, AHRQ has
coordinated the PSWG to assist AHRQ
with developing and maintaining the
Common Formats. The PSWG includes
major health agencies and offices within
the HHS—CDC, Centers for Medicare &
Medicaid Services, FDA, Health
Resources and Services Administration,
the Indian Health Service, the National
Institutes of Health, the National Library
of Medicine, Office of Healthcare
Quality, Office of the National
Coordinator for Health Information
Technology (ONC), the Office of Public
Health and Science, the Substance
Abuse and Mental Health Services
Administration—as well as the DoD and
the VA.
The PSWG assists AHRQ with
assuring the consistency of definitions/
formats with those of relevant
government agencies as refinement of
the Common Formats continues. When
developing Common Formats, AHRQ
first reviews existing patient safety
event reporting systems from a variety
of health care organizations. Working
with the PSWG and Federal subject
matter experts, AHRQ drafts and
releases beta versions of the Common
Formats for public review and
comment. To the extent practicable, the
Common Formats are also aligned with
World Health Organization (WHO)
concepts, framework, and definitions
contained in their draft International
Classification for Patient Safety (ICPS).
The process for updating and refining
the formats will continue to be an
iterative one. Future versions of the
Common Formats will be developed for
ambulatory settings, such as ambulatory
surgery centers and physician and
practitioner offices. More information
on the Common Formats can be
obtained through AHRQ’s PSO Web site:
https://www.PSO.AHRQ.gov/.
Dated: October 20, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–27892 Filed 10–31–11; 8:45 am]
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67457
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–12–12AL]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call the CDC Reports
Clearance Officer at (404) 639–5960 or
send comments to Daniel Holcomb, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to omb@cdc.gov.
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 collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
The National Hospital Care Survey
(NHCS): Ambulatory Care Pretest—
New—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States. This one-year
clearance request seeks approval to pretest: (1) Data collection from hospital
ambulatory departments including
emergency departments (ED), outpatient
departments (OPD), and ambulatory
surgery locations (ASLs) through the
E:\FR\FM\01NON1.SGM
01NON1
67458
Federal Register / Vol. 76, No. 211 / Tuesday, November 1, 2011 / Notices
National Hospital Care Survey (NHCS)
(OMB No. 0920–0212); (2) new
questions on drug-related ED visits; and
(3) new questions on colorectal cancer
screening in ambulatory surgery visits.
In 2012, a pretest of 30 hospitals will
collect data using methods approved for
the National Hospital Ambulatory
Medical Care Survey (NHAMCS) (OMB
No. 0920–0278) data collection. The
proposed pretest will test the data
collection procedures involved in
integrating the NHAMCS into the
NHCS. NHAMCS has provided data
annually since 1992 concerning the
nation’s use of hospital emergency and
outpatient departments, and since 2009,
on hospital-based ASLs. If the pretest is
successful, NHAMCS will be integrated
into NHCS in order to increase the
wealth of data on health care utilization
in hospitals across episodes of care and
to allow for linkages to other data
sources such as the National Death
Index and data from Centers for
Medicare and Medicaid Services (CMS).
The data items to be collected from
the recruited hospitals in the pretest
will include facility level data items
such as visit volume, number of
treatment areas, and information on
electronic health record systems.
Facility level data will be collected
through in-person interviews and
recorded on computerized survey
emergency department, a sample of all
patient visits will be abstracted; for each
drug-related visit within this sample,
additional drug-related data will be
abstracted. The only burden to the
respondent at the patient visit level will
be due to pulling and refiling of
approximately 133 medical records at
each ambulatory unit.
Finally, the pretest will assess the
feasibility of obtaining information on
colorectal cancer screening during
ambulatory surgery visits where a
colonoscopy is performed. The
endeavor is sponsored jointly by the
National Center for Chronic Disease
Prevention and Promotion (NCCDPHP)
and the National Cancer Institute (NCI).
The questions will be added to the
Ambulatory Surgery Patient Record
form and will be completed for patients
that have a colonoscopy performed at
the sampled visit.
Potential users of the NHCS
ambulatory data include, but are not
limited to CDC, Congressional Research
Office, Office of the Assistant Secretary
for Planning and Evaluation (ASPE),
American Health Care Association,
Centers for Medicare & Medicaid
Services (CMS), Bureau of the Census,
state and local governments, and
nonprofit organizations. There is no cost
to respondents other than their time to
participate.
instruments, at the hospital-level and at
the ambulatory unit level. It is
anticipated that each hospital will have
approximately four ambulatory units.
Patient level data items will include
basic demographic information, name,
address, social security number (if
available), and medical record number
(if available), and characteristics of the
patients including admission and
discharge dates, reason for visit,
diagnoses, diagnostic services,
procedures, medications, providers
seen, and disposition. Patient visit data
will be abstracted by field
representatives of the data collection
agent. A targeted number of patient
visits will be sampled from each
department depending on the type of
department—approximately 100 across
ambulatory units in the ED, 200 across
ambulatory units in the OPD, and 100
across ambulatory units in ASLs.
Secondly, the pretest will collect
specific information on drug-related
visits to the ED. This endeavor, funded
by the Center for Behavioral Health
Statistics & Quality (CBHSQ) of the
Substance Abuse & Mental Health
Administration (SAMHSA), will assess
the feasibility of integrating the Drug
Abuse Warning Network (DAWN) (OMB
No. 0930–0078) into the emergency
department component of the NHCS. In
each of the 30 pretest hospitals with an
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Number of
responses
per
respondent
Avg. burden
per response
(in hrs)
Total burden
hours
Type of respondent
Form
Hospital Chief Executive Officer ...........
Ancillary Service Executive ..................
Medical Record Clerk ...........................
Hospital Induction Interview ..........
Ambulatory Unit Induction ............
Pulling and Refiling Records ........
30
120
120
1
1
133
1
15/60
1/60
30
30
266
Total ...............................................
.......................................................
........................
........................
........................
326
Dated: October 26, 2011.
Daniel Holcomb,
Reports Clearance Officer, Office of the Chief
Science Officer, Centers for Disease Control
and Prevention.
[FR Doc. 2011–28218 Filed 10–31–11; 8:45 am]
srobinson on DSK4SPTVN1PROD with NOTICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Emerging Infections Programs,
Funding Opportunity Announcement
(FOA) CK12–1202, initial review.
Correction: The notice was published in
the Federal Register on September 13, 2011,
Volume 76, Number 177, Page 56461. The
place should read as follows:
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Place: Sheraton Gateway Hotel Atlanta
Airport, 1900 Sullivan Road, Atlanta, Georgia
30337, Telephone: (770) 997–1100.
Contact Person For More Information: Amy
Yang, Ph.D., Scientific Review Officer, CDC,
1600 Clifton Road NE., Mailstop E60,
Atlanta, Georgia 30333, Telephone: (404)
498–2733.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
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]]>Agencies
[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67457-67458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28218]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-12AL]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call the CDC Reports
Clearance Officer at (404) 639-5960 or send comments to Daniel Holcomb,
CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
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 collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
The National Hospital Care Survey (NHCS): Ambulatory Care Pretest--
New--National Center for Health Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, shall collect statistics on the
extent and nature of illness and disability of the population of the
United States. This one-year clearance request seeks approval to pre-
test: (1) Data collection from hospital ambulatory departments
including emergency departments (ED), outpatient departments (OPD), and
ambulatory surgery locations (ASLs) through the
[[Page 67458]]
National Hospital Care Survey (NHCS) (OMB No. 0920-0212); (2) new
questions on drug-related ED visits; and (3) new questions on
colorectal cancer screening in ambulatory surgery visits.
In 2012, a pretest of 30 hospitals will collect data using methods
approved for the National Hospital Ambulatory Medical Care Survey
(NHAMCS) (OMB No. 0920-0278) data collection. The proposed pretest will
test the data collection procedures involved in integrating the NHAMCS
into the NHCS. NHAMCS has provided data annually since 1992 concerning
the nation's use of hospital emergency and outpatient departments, and
since 2009, on hospital-based ASLs. If the pretest is successful,
NHAMCS will be integrated into NHCS in order to increase the wealth of
data on health care utilization in hospitals across episodes of care
and to allow for linkages to other data sources such as the National
Death Index and data from Centers for Medicare and Medicaid Services
(CMS).
The data items to be collected from the recruited hospitals in the
pretest will include facility level data items such as visit volume,
number of treatment areas, and information on electronic health record
systems. Facility level data will be collected through in-person
interviews and recorded on computerized survey instruments, at the
hospital-level and at the ambulatory unit level. It is anticipated that
each hospital will have approximately four ambulatory units.
Patient level data items will include basic demographic
information, name, address, social security number (if available), and
medical record number (if available), and characteristics of the
patients including admission and discharge dates, reason for visit,
diagnoses, diagnostic services, procedures, medications, providers
seen, and disposition. Patient visit data will be abstracted by field
representatives of the data collection agent. A targeted number of
patient visits will be sampled from each department depending on the
type of department--approximately 100 across ambulatory units in the
ED, 200 across ambulatory units in the OPD, and 100 across ambulatory
units in ASLs.
Secondly, the pretest will collect specific information on drug-
related visits to the ED. This endeavor, funded by the Center for
Behavioral Health Statistics & Quality (CBHSQ) of the Substance Abuse &
Mental Health Administration (SAMHSA), will assess the feasibility of
integrating the Drug Abuse Warning Network (DAWN) (OMB No. 0930-0078)
into the emergency department component of the NHCS. In each of the 30
pretest hospitals with an emergency department, a sample of all patient
visits will be abstracted; for each drug-related visit within this
sample, additional drug-related data will be abstracted. The only
burden to the respondent at the patient visit level will be due to
pulling and refiling of approximately 133 medical records at each
ambulatory unit.
Finally, the pretest will assess the feasibility of obtaining
information on colorectal cancer screening during ambulatory surgery
visits where a colonoscopy is performed. The endeavor is sponsored
jointly by the National Center for Chronic Disease Prevention and
Promotion (NCCDPHP) and the National Cancer Institute (NCI). The
questions will be added to the Ambulatory Surgery Patient Record form
and will be completed for patients that have a colonoscopy performed at
the sampled visit.
Potential users of the NHCS ambulatory data include, but are not
limited to CDC, Congressional Research Office, Office of the Assistant
Secretary for Planning and Evaluation (ASPE), American Health Care
Association, Centers for Medicare & Medicaid Services (CMS), Bureau of
the Census, state and local governments, and nonprofit organizations.
There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondent Form Number of responses per per response Total burden
respondents respondent (in hrs) hours
----------------------------------------------------------------------------------------------------------------
Hospital Chief Executive Hospital 30 1 1 30
Officer. Induction
Interview.
Ancillary Service Executive.. Ambulatory Unit 120 1 15/60 30
Induction.
Medical Record Clerk......... Pulling and 120 133 1/60 266
Refiling Records.
---------------------------------------------------------------
Total.................... ................. .............. .............. .............. 326
----------------------------------------------------------------------------------------------------------------
Dated: October 26, 2011.
Daniel Holcomb,
Reports Clearance Officer, Office of the Chief Science Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2011-28218 Filed 10-31-11; 8:45 am]
BILLING CODE 4163-18-P
