[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44881-44882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19026]


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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 ``Nursing Home Survey on Patient Safety Culture Database.''
    This proposed information collection was previously published in 
the Federal Register on May 31, 2018, and allowed 60 days for public 
comment. AHRQ received no substantive comments during this period. The 
purpose of this notice is to allow an additional 30 days for public 
comment.

DATES: Comments on this notice must be received by October 4, 2018.

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

Nursing Home Survey on Patient Safety Culture Database

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public the comment on this proposed information 
collection. 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 
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 perspectives about patient safety issues, medical error, and 
error reporting and includes 42 items that measure 12 composites of 
patient safety culture. AHRQ made the survey publicly available along 
with a Survey User's Guide and other toolkit materials in November 2008 
on the AHRQ website.
    The AHRQ Nursing Home SOPS Database consists of data from the AHRQ 
Nursing Home Survey on Patient Safety Culture. Nursing homes in the 
U.S. can voluntarily submit data from the survey to AHRQ through its 
contractor, Westat. The Nursing Home SOPS Database (OMB NO. 0935-0195, 
last approved on September 30, 2015) was developed by AHRQ in 2011 in 
response to requests from nursing homes interested in viewing their 
organizations' patient safety culture survey results. Those 
organizations submitting data receive a feedback report, as well as a 
report on the aggregated de-identified findings of the other nursing 
homes submitting data. These reports are used to assist nursing home 
staff in their efforts to improve patient safety culture in their 
organizations.
    Rationale for the information collection. The Nursing Home SOPS and 
Nursing Home SOPS Database support AHRQ's goals of promoting 
improvements in the quality and safety of health care in nursing home 
settings. The survey, toolkit materials, and database results are all 
made publicly available on AHRQ's website. Technical assistance is 
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.
    This database will:
    (1) Present results from nursing homes that voluntarily submit 
their data,
    (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.
    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 nursing home (or parent 
organization) point-of-contact (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 
collect basic demographic information about the nursing home and 
initiate the registration process.
    (2) Data Use Agreement--The purpose of the data use agreement, 
completed by the nursing home POC, is to state how data submitted by 
nursing homes will be used and provides privacy assurances.
    (3) Nursing Home Site Information Form--The purpose of the site 
information form, completed by the nursing home POC, is to collect 
background characteristics of the nursing home. This information will 
be used to analyze data collected with the Nursing Home SOPS survey.
    (4) Data File(s) Submission--POCs upload their data file(s) using 
the data file specifications, to ensure that users submit standardized 
and consistent data in the way variables are named, coded and 
formatted. The number of submissions to the database is likely to vary 
each year because nursing homes do not administer the survey and submit 
data every year. Data submission is typically handled by one POC who 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. POCs submit data on behalf of 5 nursing homes, on average, 
because many nursing homes are part of a QIO or larger nursing home or 
health system that includes many nursing home sites, or the POC is a 
vendor that is submitting data for multiple nursing homes.
    Survey data from the AHRQ Nursing Home Survey on Patient Safety 
Culture are used to produce three types of products:
    (1) A Nursing Home SOPS User Database Report that is made publicly 
available on the AHRQ website;

[[Page 44882]]

    (2) Individual Nursing Home Survey Feedback Reports are 
individualized reports produced for each nursing home that submits data 
to the database; and
    (3) Research data sets of individual-level and nursing home-level 
de-identified data to enable researchers to conduct analyses. All data 
released in a data set are de-identified at the individual-level and 
the nursing home-level.
    Nursing homes will be invited to voluntarily submit their Nursing 
Home SOPS survey data to the database. The data are then cleaned and 
aggregated and used to produce a Database Report in PDF format that 
displays averages, standard deviations, and percentile scores on the 
survey's 42 items and 12 patient safety culture composites, as well as 
displaying these results by nursing home characteristics (bed size, 
urbanicity, ownership, and region) and respondent characteristics (work 
area/unit, staff position, interaction with residents, shift worked 
most often, and tenure in nursing home).
    Each nursing home that submits data receives an individualized 
survey feedback report that presents their results alongside the 
aggregate results from other participating nursing homes.
    Nursing homes use the Nursing Home SOPS Database Reports and 
Individual Nursing Home Survey Feedback Reports for a number of 
purposes, to:
     Raise staff awareness about patient safety.
     Elucidate and assess the current status of patient safety 
culture in their nursing home.
     Identify strengths and areas for patient safety culture 
improvement.
     Evaluate trends in patient safety culture change over 
time.
     Evaluate the cultural impact of patient safety initiatives 
and interventions.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in the database. An estimated 60 POCs, 
each representing an average of 5 individual nursing homes, will 
complete the database submission steps and forms. Each POC will submit 
the following:
     Eligibility and registration form (completion is estimated 
to take about 3 minutes).
     Data Use Agreement (completion is estimated to take about 
3 minutes).
     Nursing Home Site Information Form (completion is 
estimated to take about 5 minutes).
     Survey data submission will take an average of one hour.
    The total annual burden hours are estimated to be 91 hours.
    Exhibit 2 shows the estimated annualized cost burden based on the 
respondents' time to submit their data. The cost burden is estimated to 
be $4,085 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...................              60               1            3/60               3
Data Use Agreement..............................              60               1            3/60               3
Nursing Home Site Information Form..............              60               5            5/60              25
Data Files Submission...........................              60               1               1              60
                                                 ---------------------------------------------------------------
    Total.......................................              NA              NA              NA              91
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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 Forms..................              60               3          $44.89            $135
Data Use Agreement..............................              60               3           44.89             135
Nursing Home Site Information Form..............              60              25           44.89           1,122
Data Files Submission...........................              60              60           44.89           2,693
                                                 ---------------------------------------------------------------
    Total.......................................             240              91              NA           4,085
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* The wage rate in Exhibit 2 is based on May 2017 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 https://www.bls.gov/oes/current/naics3_623000.htm. The hourly wage of $44.89 is the weighted mean
  of $45.81 (General and Operations Managers 11-1021; N = 40) and $43.04 (Medical and Health Services Managers
  11-9111; N = 20).

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's 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.

Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018-19026 Filed 8-31-18; 8:45 am]
 BILLING CODE 4160-90-P