```

[Federal Register Volume 77, Number 17 (Thursday, January 26, 2012)]
[Notices]
[Pages 4038-4041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1400]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: ``Nursing Home 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 November 2nd, 2011 and allowed 60 days for 
public comment. No comments were 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 February 27, 2012.

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 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 email at 
doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

Nursing Home 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

[[Page 4039]]

collection of information for the AHRQ Nursing Home Survey on Patient 
Safety Culture (Nursing Home SOPS) Comparative Database. The Nursing 
Home SOPS Comparative Database consists of data from the AHRQ Nursing 
Home Survey on Patient Safety Culture. Nursing homes in the U.S. are 
asked to voluntarily submit data from the survey to AHRQ through its 
contractor, Westat. The Nursing Home SOPS Database is modeled after the 
Hospital SOPS Database [OMB NO. 0935-0162, approved 05/04/2010] that 
was originally 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 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 nursing homes, AHRQ developed 
and pilot tested the Nursing Home Survey on Patient Safety Culture with 
OMB approval (OMB NO.0935-0132; Approved July 5, 2007). The survey is 
designed to enable nursing homes to assess provider and 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 into the public domain along with a Survey 
User's Guide and other toolkit materials in November 2008 on the AHRQ 
Web site (located at http://www.ahrq.gov/qual/patientsafetyculture/nhsurvindex.htm). Since its release, the survey has been voluntarily 
used by hundreds of nursing homes in the U.S.
    The Nursing Home SOPS and the Comparative Database are supported by 
AHRQ to meet its goals of promoting improvements in the quality and 
safety of health care in nursing home settings. The survey, toolkit 
materials, and preliminary 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 nursing homes, to 
facilitate the use of these materials for nursing home patient safety 
and quality improvement.
    The goal of this project is to create the Nursing Home SOPS 
Comparative Database. This database will (1) allow nursing homes to 
compare their patient safety culture survey results with those of other 
nursing homes; (2) provide data to nursing homes to facilitate internal 
assessment and learning in the patient safety improvement process; and 
(3) provide supplemental information to help nursing homes identify 
their strengths and areas with potential for improvement in patient 
safety culture. De-identified data files will also be available to 
researchers conducting patient safety analysis. The database will 
include 42 items that measure 12 areas, or composites, of 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 healthcare and on systems for the delivery of such care, 
including activities with respect to the quality, effectiveness, 
efficiency, appropriateness and value of healthcare services and with 
respect to quality measurement and improvement, and database 
development. 42 U.S.C. 299a(a)(1) and (2), and (a)(8).

Method of Collection

    To achieve the goal of this project the following activities and 
data collections will be implemented:
    (1) Nursing Home Eligibility and Registration Form--The purpose of 
this form is to determine the eligibility status and initiate the 
registration process for nursing homes seeking to voluntarily submit 
their NH SOPS data to the NH SOPS Comparative Database. The nursing 
home (or parent organization) point of contact (POC) will complete the 
form. The POC is either a corporate level health care manager for a 
Quality Improvement Organization (QIO), a survey vendor who contracts 
with a nursing home to collect their data, or a nursing home Director 
of Nursing or nurse manager. Many nursing homes are part of a QIO or 
larger nursing home or health system that includes many nursing home 
sites
    (2) Data Use Agreement--The purpose of this form is to obtain 
authorization from nursing homes to use their voluntarily submitted NH 
SOPS data for analysis and reporting according to the terms specified 
in the Data Use Agreement (DUA). The nursing home POC will complete the 
form.
    (3) Nursing Home Site Information Form--The purpose of this form is 
to obtain basic information about the characteristics of the nursing 
homes submitting their NH SOPS data to the NH SOPS Comparative Database 
(e.g., bed size, urbanicity, ownership, and geographic region). The 
nursing home POC will complete the form.
    (4) Data Submission--After the nursing home POC has completed the 
Nursing Home Eligibility and Registration Form, the Data Use Agreement 
and the Nursing Home Site Information Form they will submit their data 
from the NH SOPS to the NH SOPS Comparative Database.
    Data from the AHRQ Nursing Home Survey on Patient Safety Culture 
are used to produce three types of products: (1) A Nursing Home SOPS 
Comparative Database Report that is produced periodically and made 
available in the public domain on the AHRQ Web site (see http://www.ahrq.gov/qual/nhsurvey11/nhsurv111.pdf for the 2011 report); (2) 
Nursing Home Survey Feedback Reports that are confidential, customized 
reports produced for each nursing home that submits data to the 
database; and (3) Research data sets of staff-level and nursing home-
level de-identified data that enable researchers to conduct additional 
analyses.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
nursing home to participate in the Nursing Home SOPS Comparative 
Database. The POC completes a number of data submission steps and 
forms, beginning with completion of the online Nursing Home SOPS 
Database Eligibility and Registration form and Data Use Agreement, 
which will be completed for 85 nursing homes or groups of affiliated 
nursing homes annually. The Nursing Home Site Information Form will be 
completed for each individual nursing home; since each POC represents 
an average of 5 nursing homes a total of 425 Information Forms will be 
completed annually and requires about 5 minutes to complete. The POC 
will submit data for all of the nursing homes they represent which will 
take about 5 and \1/2\ hours, including the amount of time POCs 
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. The total annual burden hours are 
estimated to be 511.
    Nursing homes administer the AHRQ Nursing Home Survey on Patient 
Safety Culture on a periodic basis. Hospitals submitting to the 
Hospital SOPS Comparative Database administer the survey every 16 
months on average. Similarly, the number of nursing home submissions to 
the database is likely to vary each year because nursing homes do not 
administer the survey and submit data every year. The 85 respondents/
POCs shown in Exhibit 1 are based on an estimate of nursing homes 
submitting data in the coming years, with the following assumptions:

     30 POCs for QIOs submitting on behalf of 10 nursing homes 
each.

[[Page 4040]]

     5 POCs for vendors outside of QIOs submitting on behalf of 
10 nursing homes each.
     50 independent nursing homes submitting on their own 
behalf.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                Number of
                Form name                     Number of       responses per       Hours per       Total burden
                                          respondents/POCs         POC            response            hours
----------------------------------------------------------------------------------------------------------------
Eligibility/Registration Forms..........                85                 1              3/60                 4
Data Use Agreement......................                85                 1              3/60                 4
Nursing Home Site Information Form......                85                 5              5/60                35
Data Submission.........................                85                 1               5.5               468
                                         -----------------------------------------------------------------------
    Total...............................               340                NA                NA               511
----------------------------------------------------------------------------------------------------------------

    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to submit their data. The cost burden is estimated to 
be $21,152 annually.

                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                              Number of       Total burden     Average hourly      Total cost
                Form name                 respondents/POCs        hours          wage rate *         burden
----------------------------------------------------------------------------------------------------------------
Eligibility/Registration Forms..........                85                 4            $41.39              $166
Data Use Agreement......................                85                 4             41.39               166
Nursing Home Site Information Form......                85                35             41.39             1,449
Data Submission.........................                85               468             41.39            19,371
                                         -----------------------------------------------------------------------
    Total...............................               340               511                NA            21,152
----------------------------------------------------------------------------------------------------------------
* The wage rate in Exhibit 2 is based on May 2009 National Industry-Specific Occupational Employment and Wage
  Estimates, Bureau of Labor Statistics, U.S. Dept of Labor. Mean hourly wages for nursing home POCs are located
  at http://www.bls.gov/oes/2009/may/naics4_623100.htm and http://www.bls.gov/oes/2009/may/naics2_62.htm. The
  hourly wage of $41.39 is the weighted mean of $41.94 (General and Operations Managers; N = 25), $37.29
  (Medical and Health Services Managers; N = 25), $42.89 (General and Operations Managers; N = 30) and $50.00
  (Computer and Information Systems Managers; N = 5).

Estimated Annual Costs to the Federal Government

    The estimated annualized cost to the government for developing, 
maintaining, and managing the database and analyzing the data and 
producing reports is shown below. The cost is estimated to be $310,000 
annually. The total cost over the three years of this information 
collection request is $930,000.

                  Exhibit 3--Estimated Annualized Cost
------------------------------------------------------------------------
           Cost component                Total cost      Annualized cost
------------------------------------------------------------------------
Project Development.................           $59,715           $19,905
Data Collection Activities..........            82,107            27,369
Data Processing and Analysis........           111,963            37,321
Publication of Results..............           111,966            37,322
Project Management..................             7,464             2,488
Overhead............................           556,785           185,595
                                     -----------------------------------
    Total...........................           930,000           310,000
------------------------------------------------------------------------

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 healthcare research and 
healthcare 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.

[[Page 4041]]

    Dated: January 17, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-1400 Filed 1-25-12; 8:45 am]
BILLING CODE 4160-90-M
```