[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40304-40306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14615]
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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: ``Hospital Survey on Patient Safety Culture Comparative
Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C.
3501-3521, AHRQ invites the public to comment on this proposed
information collection.
This proposed information collection was previously published in
the Federal Register on April 8, 2016, and allowed 60 days for public
comment. AHRQ received no substantive comments. The purpose of this
notice is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by July 21, 2016.
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
email at [email protected] (attention: AHRQ's desk officer).
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Hospital Survey on Patient Safety Culture Comparative Database
In 1999, the Institute of Medicine called for health care
organizations to develop a ``culture of safety'' such that their
workforce and processes focus on improving the reliability and safety
of care for patients (IOM, 1999; To Err is Human: Building a Safer
Health 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 (SOPS)Culture with OMB approval (OMB
NO. 0935-0115; Approved 2/4/2003).
The survey is designed to enable hospitals to assess staff opinions
about patient safety issues, medical errors, and error reporting. The
survey includes 42 items that measure 12 composites of patient safety
culture. AHRQ made the survey publicly available on the AHRQ Web site
along with a Survey User's Guide and other toolkit materials in
November 2004 (located at http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/hospital/index.html). Since its
release, the survey has been voluntarily used by hundreds of hospitals
in the U.S.
The Hospital SOPS Comparative Database consists of data from the
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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 Hospital SOPS Database (OMB NO. 0935-0162,
last approved on September 26, 2013) 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.
Rationale for the information collection. The Hospital SOPS and the
Comparative Database support AHRQ's goals of promoting improvements in
the quality and safety of health care in hospital settings. The survey,
toolkit materials, and comparative database results are all made
publicly available on AHRQ's Web site. Technical assistance is 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.
Request for information collection approval. AHRQ requests that the
Office of Management and Budget (OMB) reapprove, 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; OMB NO. 0935-0162, last approved on September 26, 2013.
This database will:
(1) Allow hospitals to compare their patient safety culture survey
results with those of other hospitals,
(2) Provide data to hospitals to facilitate internal assessment and
learning in the patient safety improvement process, and
(3) Provide supplemental information to help hospitals identify
their strengths and areas with potential for improvement in patient
safety culture.
This study is being conducted by AHRQ through its contractor,
Westat, 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 quality measurement and improvement. 42 U.S.C. 299a(a)(1)
and (2).
Method of Collection
To achieve the goal of this project the following activities and
data collections will be implemented:
(1) Eligibility and Registration Form--The hospital pointofcontact
(POC) completes a number of data submission steps and forms, beginning
with the completion of an online eligibility and registration form. The
purpose of this form is to determine the eligibility status and
initiate the registration process for hospitals seeking to voluntarily
submit their Hospital SOPS data to the Hospital SOPS Comparative
Database.
(2) Data Use Agreement--The purpose of the data use agreement,
completed by the hospital POC, is to state how data submitted by
hospitals will be used and provides confidentiality assurances.
(3) Hospital Site Information Form--The purpose of the site
information form is to obtain basic information about the
characteristics of the hospitals submitting their Hospital SOPS data to
the Hospital SOPS Comparative Database (e.g. number of providers and
staff, ownership, and teaching status). The hospital POC completes the
form.
(4) Data Files Submission--The number of submissions to the
database is likely to vary each year because hospitals do not
administer the survey and submit data every year. Data submission is
typically handled by one POC who is either a manager or a survey vendor
who contracts with a hospital to collect its data. POCs submit data on
behalf of 3 hospitals, on average, because many hospitals are part of a
health system that includes many hospitals, or the POC is a vendor that
is submitting data for multiple hospitals.
Survey data from the AHRQ Hospital Survey on Patient Safety Culture
is used to produce three types of products: (1) A Hospital SOPS
Comparative Database Report that is produced periodically and made
publicly available on the AHRQ Web site (see http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/hospital/hosp-reports.html); (2) Individual Hospital Survey Feedback Reports
which are confidential, customized reports produced for each hospital
that submits data to the database (the number of reports produced is
based on the number of hospitals submitting each year); and (3)
Research data sets of individual-level and hospital-level, de-
identified data to enable researchers to conduct analyses.
Hospitals are asked to voluntarily submit their Hospital SOPS
survey data to the comparative database. 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 composites of patient safety culture, 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.
Data submitted by hospitals are used to give each hospital its own
customized survey feedback report that presents its results compared to
the latest comparative database results. If the hospital submits data
in two consecutive database submission years, its survey feedback
report also presents trend data, comparing its previous and most recent
data.
Hospitals use the Hospital SOPS, Comparative Database Reports and
Individual Hospital Survey Feedback Reports for a number of purposes,
to:
Raise staff awareness about patient safety.
Diagnose and assess the current status of patient safety
culture in their hospital.
Identify strengths and areas for improvement in patient
safety culture.
Examine trends in patient safety culture change over time.
Evaluate the cultural impact of patient safety initiatives
and interventions.
Facilitate meeting Joint Commission hospital accreditation
standards in Leadership that require a regular assessment of hospital
patient safety culture.
Compare patient safety culture survey results with other
hospitals in their efforts to improve patient safety and quality.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in the database. An estimated 304
POCs, each representing an average of 3 individual hospitals each, will
complete the database submission steps and forms annually. 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. Completing the registration form will take about 3 minutes.
The Hospital Information Form is completed by all POCs for each of
their hospitals (304 x 3 = 912). The total annual burden hours are
estimated to be 410.
Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to submit their data. The cost burden is estimated to
be $21,801 annually.
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Exhibit 1--Estimated Annualized Burden Hours
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Number of Number of
Form name respondents/ responses per Hours per Total burden
POCs POC response hours
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Eligibility/Registration Form................... 304 1 3/60 15
Data Use Agreement.............................. 304 1 3/60 15
Hospital Information Form....................... 304 3 5/60 76
Data Files Submission........................... 304 1 1 304
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Total....................................... 1,216 NA NA 410
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Exhibit 2--Estimated Annualized Cost Burden
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Number of
Form name respondents/ Total burden Average hourly Total cost
POCs hours wage rate * burden
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Eligibility/Registration Form................... 304 15 $53.17 $798
Data Use Agreement.............................. 304 15 53.17 798
Hospital Information Form....................... 304 76 53.17 4,041
Data Files Submission........................... 304 304 53.17 16,164
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Total....................................... 1,216 410 NA 21,801
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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 2014 National Industry-Specific Occupational Employment
and Wage Estimates NAICS 622000--Hospitals, located at http://www.bls.gov/oes/current/naics3_622000.htm. Wage
rate of $53.17 is based on the mean hourly wages for Medical and Health Services Managers (11-9111).
Request for Comments
In accordance with the Paperwork Reduction Act, 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 and
health care 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.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-14615 Filed 6-20-16; 8:45 am]
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