[Federal Register: November 6, 2009 (Volume 74, Number 214)]
[Notices]
[Page 57493-57495]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no09-57]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Collection of Information for Agency for Healthcare Research
and Quality's (AHRQ) Hospital Survey on Patient Safety Culture
Comparative Database.'' In accordance with the Paperwork Reduction Act
of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection was previously published in
the Federal Register on September 2nd, 2009 and allowed 60 days for
public comment. One comment was received. The purpose of this notice is
to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by December 7, 2009.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
e-mail at OIRA_submission@omb.eop.gov (attention: AHRQ's desk
officer).
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
doris.lefkowitz@ahrg.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Collection of Information for Agency for Healthcare Research and
Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative
Database
The Agency for Healthcare Research and Quality (AHRQ) requests that
the Office of Management and Budget (OMB) approve, under the Paperwork
Reduction Act of 1995, AHRQ's collection of information for the AHRQ
Hospital Survey on Patient Safety Culture (Hospital SOPS) Comparative
Database. The Hospital SOPS Comparative Database consists of data from
the AHRQ Hospital Survey on Patient Safety Culture. Hospitals in the
U.S. are asked to voluntarily submit data from the survey to AHRQ,
through its contractor, Westat. The database was developed by AHRQ in
2006 in response to requests from hospitals interested in knowing how
their patient safety culture survey results compare to those of other
hospitals in their efforts to improve patient safety.
In 1999, the Institute of Medicine called for health care
organizations to develop a ``culture of safety'' in which their
workforces and processes focus on improving the reliability and safety
of care for patients (IOM, 1999; To Err is Human: Building a Safer
Health
[[Page 57494]]
System). To respond to the need for tools to assess patient safety
culture in health care, AHRQ developed and pilot tested the Hospital
Survey on Patient Safety Culture with OMB approval (OMB No. 0935-0115;
Approved 2/4/2003). The survey was designed to enable hospitals to
assess staff opinions about patient safety issues, medical error, and
error reporting and includes 42 items that measure 12 dimensions of
patient safety culture. AHRQ released the survey in the public domain
along with a Survey User's Guide and other toolkit materials in
November 2004 on the AHRQ Web site. Since its release, the survey has
been voluntarily used by hundreds of hospitals in the U.S.
The Hospital SOPS survey and the Hospital SOPS Comparative Database
are supported by AHRQ to meet its goals of promoting improvements in
the quality and safety of health care in hospital settings. This
project is conducted pursuant to AHRQ's statutory authority to conduct
and support research on health care and on systems for the delivery of
such care, including activities with respect to the quality,
effectiveness, efficiency, appropriateness and value of health care
services and with respect to health statistics, surveys, and database
development. See 42 U.S.C. 299a(a)(1) and (8). The surveys, toolkit
materials, and comparative database results are all made available in
the public domain along with technical assistance, provided by AHRQ
through its contractor at no charge to hospitals, to facilitate the use
of these materials for hospital patient safety and quality improvement.
Method of Collection
Information for the Hospital SOPS database has been collected by
AHRQ on an annual basis since 2006. Hospitals are asked to voluntarily
submit their Hospital SOPS survey data to the comparative database
between May 1 and June 30. The data are then cleaned and aggregated and
used to produce a Comparative Database Report that displays averages,
standard deviations, and percentile scores on the survey's 42 items and
12 patient safety culture dimensions, as well as displaying these
results by hospital characteristics (bed size, teaching status,
ownership) and respondent characteristics (hospital work area, staff
position, and those with direct interaction with patients). In
addition, trend data, showing changes in scores over time, are
presented from hospitals that have submitted to the database more than
once.
Estimated Annual Respondent Burden
Hospitals administer the AHRQ Hospital Survey on Patient Safety
Culture every 16 months on average. Therefore, the number of hospital
submissions to the database varies each year because hospitals do not
submit data every year. The 250 respondents/point-of-contacts (POCs)
shown in Exhibit I are based on an estimated increase in the number of
submissions in 2010 and 2011 (above the 180 respondents from 2009).
Data submission is typically handled by one POC who is either a
hospital patient safety manager or a survey vendor. The POC completes a
number of data submission steps and forms, beginning with completion of
an online Eligibility and Registration Form. The POCs typically submit
data on behalf of 3 hospitals, on average, because many hospitals are
part of a multi-hospital system that is submitting data, or the POC is
a vendor that is submitting data for multiple hospitals. In 2009, 180
POCs submitted data on behalf of a total of 535 hospitals (an average
of 3 hospital submissions per POC). Exhibits 1 and 2 are based on the
estimated number of individual POCs who will complete the database
submission steps and forms in the coming years, not based on the number
of hospitals. The Patient Safety Improvement Initiatives Form is
completed only by POCs from trending hospitals that have submitted data
more than once, so only about half of the POCs each year will be asked
to complete the form for each of the 3 hospitals (on average) they are
submitting data for. The Hospital Information Form is completed by all
POCs for each of their hospitals. The total annual burden hours are
estimated to be 1,508.
Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to submit their data. The cost burden is estimated to
be $69,438 annually.
Exhibit 1--Estimated Annualized Burden Hours
[Hours total]
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Number of Number of
Form name respondents/ response per Response per Total burden
POCs POCs response hours
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Eligibility/Registration Form and Data 250 1 5.6 1,400
Submission *...................................
Data Use Agreement.............................. 250 1 3/60 13
Patient Safety Improvement Initiatives Form (for 125 3 5/60 32
trending hospitals only).......................
Hospital Information Form....................... 250 3 5/60 63
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Total................................... 875 NA NA 1,508
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* The Eligibility and Registration Form requires 3 minutes to complete; however about 5.5 hours is required to
prepare/plan for the data submission. This includes the amount of time POCs and other hospital staff (CEO,
lawyer, database administrator) typically spend deciding whether to participate in the database and preparing
their materials and data set for submission to the database, and performing the submission.
Exhibit 2--Estimated Annualized Cost Hours
[Hours total]
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Number of
Form name responses per Total burden Average hourly Total cost
POCs hours wage rate* burden
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Eligibility/Registration Form and Data 250 1,400 $46.11 $64,554
Submission.....................................
Data Use Agreement.............................. 250 13 45.22 588
Patient Safety Improvement Initiatives Form (for 125 32 45.22 1,447
trending hospitals only).......................
Hospital Information Form....................... 250 63 45.22 2,849
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[[Page 57495]]
Total................................... 875 1,508 NA $69,438
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* Wage rates were calculated using the mean hourly wage based on occupational employment and wage estimates from
the Dept of Labor, Bureau of Labor Statistics' May 2008 National Industry-Specific Occupational Employment and
Wage Estimates NAICS 622000--Hospitals, located at http://www.bls.gov/oes/2008/may/naics3_22000.htm. Wage
rate of $46.22 is based on the mean hourly wages for Medical and Health Services Managers. Wage rate of $46.11
is the weighted mean hourly wage for: Medical and Health Services Managers ($45.22 x 2.6 hours = $117.57),
Lawyers ($62.95 x .5 hours =$31 .48), Chief Executives ($89.16 x .5 hours = $44.58), and Database
Administrators ($32.30 x 2 hours = $64.60) [Weighted mean = ($117.57 + 31.48 + 44.58 + 64.60)/5.6 hours =
$258.2315.6 hours = $46.1 1/hour].
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the estimated annualized cost to the government for
developing, maintaining, and managing the database and analyzing the
data and producing reports. The cost is estimated to be $250,000
annually.
Exhibit 3--Estimated Annualized Cost
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Annualized
Cost component cost
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Database Development and Maintenance....................... $50 000
Data Submission............................................ 75,000
Data Analysis & Reports.................................... 125,000
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Total.................................................. 250,000
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Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, comments on AHRQ's information collection are requested
with regard to any of the following: (a) Whether the proposed
collection of information is necessary for the proper performance of
AHRQ health care research, quality improvement and information
dissemination functions, including whether the information will have
practical utility; (b) the accuracy of AHRQ's estimate of burden
(including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use
of automated collection techniques or other forms of information
technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: October 21, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-26673 Filed 11-5-09; 8:45 am]