[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
                                                 ---------------------------------------------------------------
    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
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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]
 BILLING CODE 4160-90-M