[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Notices]
[Pages 45455-45457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21079]


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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.

DATES: Comments on this notice must be received by November 2, 2009.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at 
[email protected].
    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 
[email protected].

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

[[Page 45456]]

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 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. 
0935-01 15; 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)(l) 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 1 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
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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 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
                                                 ---------------------------------------------------------------
    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 Burden
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                                                     Number of
                    Form name                      respondents/    Total burden   Average hourly    Total cost
                                                       POCs            hours        wage rate*        burden
----------------------------------------------------------------------------------------------------------------
Eligibility/Registration Form and Data                       250           1,400          $46.11         $64,554
 Submission.....................................

[[Page 45457]]

 
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
                                                 ---------------------------------------------------------------
    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_622000.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 =
  $258.23/5.6 hours = $46.11/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
                                                         ---------------
    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: August 26, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-21079 Filed 9-1-09; 8:45 am]
BILLING CODE 4160-90-M