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 Department of Health and Human Services Agency for Healthcare Research and Quality
 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 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 
                        *OIRA_submission@omb.eop.gov*
                         (attention: AHRQ's desk 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 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;
                    ( print 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
Form name
Number of
                             respondents/POCs
Number of
                             responses per POC
Hours per
                             response
Total burden hoursEligibility/Registration Form
60
1
3/60
3Data Use Agreement
60
1
3/60
3Nursing Home Site Information Form
60
5
5/60
25Data Files Submission
60
1
1
60Total
NA
NA
NA
91
 Exhibit 2—Estimated Annualized Cost Burden
Form name
Number of
                             respondents/POCs
Total burden hours
Average
                             hourly wage 
                             rate *
Total cost
                             burdenEligibility/Registration Forms
60
3
$44.89
$135Data Use Agreement
60
3
44.89
135Nursing Home Site Information Form
60
25
44.89
1,122Data Files Submission
60
60
44.89
2,693Total
240
91
NA
4,085* 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