81 FR 20640 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 81, Issue 68 (April 8, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 68 (April 8, 2016)
| Page Range | 20640-20642 | |
| FR Document | 2016-08020 |
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)] [Notices] [Pages 20640-20642] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08020] ======================================================================= ----------------------------------------------------------------------- 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: ``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. DATES: Comments on this notice must be received by June 7, 2016. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email 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 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 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 along with a Survey User's Guide and other toolkit materials in November 2004 on the AHRQ Web site (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 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 in their efforts to improve patient safety. 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: [[Page 20641]] (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 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 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 the hospital's 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. Exhibit 1--Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Number of Form name respondents/ responses per Hours per Total burden POCs POC response hours ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- [[Page 20642]] Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Average Form Name respondents/ Total burden hourly wage Total cost POCs hours 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 ---------------------------------------------------------------------------------------------------------------- * 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, Acting Director. [FR Doc. 2016-08020 Filed 4-7-16; 8:45 am] BILLING CODE 4160-90-P
![20640 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
A. Purpose information collection documents from develop a ‘‘culture of safety’’ such that
The U.S. Government conducts the General Services Administration, their workforce and processes focus on
criminal checks to establish that Regulatory Secretariat Division (MVCB), improving the reliability and safety of
applicants or incumbents working for 1800 F Street NW., Washington, DC care for patients (IOM, 1999; To Err is
the Government under contract may 20405, telephone 202–501–4755. Please Human: Building a Safer Health
have unescorted access to federally cite OMB Control No. 3090–0283, System). To respond to the need for
controlled facilities. GSA uses the Contractor Information Worksheet; GSA tools to assess patient safety culture in
Contractor Information Worksheet; GSA Form 850 in all correspondence. The health care, AHRQ developed and pilot
Form 850, and digitally captured form can be downloaded from the GSA tested the Hospital Survey on Patient
fingerprints to conduct a FBI National Forms Library at http://www.gsa.gov/ Safety Culture with OMB approval
Criminal Information Check (NCIC) for forms. Type GSA 850 in the form search (OMB NO. 0935–0115; Approved
each contractor’s physical access field. 2/4/2003).
determination to GSA-controlled Dated: March 31, 2016. The survey is designed to enable
facilities and/or logical access to GSA- David A. Shive, hospitals to assess staff opinions about
controlled information systems. Manual Chief Information Officer. patient safety issues, medical errors, and
fingerprint card SF–87 is used for [FR Doc. 2016–08146 Filed 4–7–16; 8:45 am]
error reporting. The survey includes 42
exception cases such as contractor’s items that measure 12 composites of
BILLING CODE 6820–34–P
significant geographical distance from patient safety culture. AHRQ made the
fingerprint enrollment sites. survey publicly available along with a
The Office of Management and Budget Survey User’s Guide and other toolkit
DEPARTMENT OF HEALTH AND materials in November 2004 on the
(OMB) Guidance M–05–24 for
HUMAN SERVICES AHRQ Web site (located at http://
Homeland Security Presidential
Directive (HSPD) 12, authorizes Federal Agency for Healthcare Research and www.ahrq.gov/professionals/quality-
departments and agencies to ensure that Quality patient-safety/patientsafetyculture/
contractors have limited/controlled hospital/index.html). Since its release,
access to facilities and information Agency Information Collection the survey has been voluntarily used by
systems. GSA Directive CIO P 2181.1 Activities: Proposed Collection; hundreds of hospitals in the U.S.
Homeland Security Presidential Comment Request The Hospital SOPS Comparative
Directive-12, Personal Identity Database consists of data from the
Verification and Credentialing (available AGENCY: Agency for Healthcare Research AHRQ Hospital Survey on Patient
at http://www.gsa.gov/hspd12), states and Quality, HHS. Safety Culture. Hospitals in the U.S. are
that GSA contractors must undergo a ACTION: Notice. asked to voluntarily submit data from
minimum of an FBI National Criminal the survey to AHRQ, through its
Information Check (NCIC) to receive SUMMARY: This notice announces the
contractor, Westat. The Hospital SOPS
unescorted physical access to GSA- intention of the Agency for Healthcare
Database (OMB NO. 0935–0162, last
controlled facilities and/or logical Research and Quality (AHRQ) to request
approved on September 26, 2013) was
access to GSA-controlled information that the Office of Management and
developed by AHRQ in 2006 in
systems. Budget (OMB) approve the proposed
response to requests from hospitals
Contractors’ Social Security Number information collection project:
interested in knowing how their patient
is needed to keep records accurate, ‘‘Hospital Survey on Patient Safety
safety culture survey results compare to
because other people may have the same Culture Comparative Database.’’ In
those of other hospitals in their efforts
name and birth date. Executive Order accordance with the Paperwork
to improve patient safety.
9397, Numbering System for Federal Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on Rationale for the information
Accounts Relating to Individual collection. The Hospital SOPS and the
Persons, also allows Federal agencies to this proposed information collection.
Comparative Database support AHRQ’s
use this number to help identify DATES: Comments on this notice must be
goals of promoting improvements in the
individuals in agency records. received by June 7, 2016.
quality and safety of health care in
ADDRESSES: Written comments should hospital settings. The survey, toolkit
B. Annual Reporting Burden
be submitted to: Doris Lefkowitz, materials, and comparative database
Respondents: 25,000. Reports Clearance Officer, AHRQ, by results are all made publicly available
Responses per Respondent: 1. email at doris.lefkowitz@AHRQ.hhs.gov. on AHRQ’s Web site. Technical
Total Annual Responses: 25,000. Copies of the proposed collection assistance is provided by AHRQ through
Hours per Response: .25. plans, data collection instruments, and its contractor at no charge to hospitals,
Total Burden Hours: 6,250. specific details on the estimated burden to facilitate the use of these materials for
C. Public Comments can be obtained from the AHRQ Reports hospital patient safety and quality
Clearance Officer. improvement.
Public comments are particularly FOR FURTHER INFORMATION CONTACT:
invited on: Whether this collection of Request for information collection
Doris Lefkowitz, AHRQ Reports approval. AHRQ requests that the Office
information is necessary and whether it Clearance Officer, (301) 427–1477, or by
will have practical utility; whether our of Management and Budget (OMB)
email at doris.lefkowitz@AHRQ.hhs.gov. reapprove, under the Paperwork
mstockstill on DSK4VPTVN1PROD with NOTICES
estimate of the public burden of this
SUPPLEMENTARY INFORMATION: Reduction Act of 1995, AHRQ’s
collection of information is accurate,
and based on valid assumptions and Proposed Project collection of information for the AHRQ
methodology; ways to enhance the Hospital Survey on Patient Safety
quality, utility, and clarity of the Hospital Survey on Patient Safety Culture (Hospital SOPS) Comparative
information to be collected. Culture Comparative Database Database; OMB NO. 0935–0162, last
Obtaining Copies of Proposals: In 1999, the Institute of Medicine approved on September 26, 2013.
Requesters may obtain a copy of the called for health care organizations to This database will:
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EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of Average
Total burden Total
Form Name respondents/ hourly
hours cost burden
POCs wage rate*
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
* 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, lo-
cated 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 definitions and reporting formats assembled and developed by providers
In accordance with the Paperwork (Common Formats) for reporting on for reporting to PSOs and the
Reduction Act, comments on AHRQ’s health care quality and patient safety. information received and analyzed by
information collection are requested The purpose of this notice is to PSOs—called ‘‘patient safety work
with regard to any of the following: (a) announce the availability of new product’’—is privileged and
Whether the proposed collection of formats for public review and comment, confidential. Patient safety work
information is necessary for the proper Common Formats for Event Reporting product is used to conduct patient
performance of AHRQ health care for Hospitals Version 2.0. safety activities, which may include
research and health care information DATES: May 9, 2016. identifying events, patterns of care, and
dissemination functions, including ADDRESSES: The Common Formats for unsafe conditions that increase risks
whether the information will have Event Reporting for Hospitals Version and hazards to patients. Definitions and
practical utility; (b) the accuracy of 2.0, and the remaining Common other details about PSOs and patient
AHRQ’s estimate of burden (including Formats, can be accessed electronically safety work product are included in the
hours and costs) of the proposed at the following HHS Web site: http:// Patient Safety Act and Patient Safety
collection(s) of information; (c) ways to www.pso.ahrq.gov/common/. Rule which can be accessed
enhance the quality, utility, and clarity electronically at: http://
FOR FURTHER INFORMATION CONTACT:
of the information to be collected; and www.pso.ahrq.gov/legislation/.
Cathryn Bach, Center for Quality
(d) ways to minimize the burden of the Improvement and Patient Safety, AHRQ, Definition of Common Formats
collection of information upon the 5600 Fishers Lane, Rockville, MD
respondents, including the use of 20857; Telephone (toll free): (866) 403– The term ‘‘Common Formats’’ refers
automated collection techniques or 3697; Telephone (local): (301) 427– to the common definitions and reporting
other forms of information technology. 1111; TTY (toll free): (866) 438–7231; formats, specified by AHRQ, that allow
Comments submitted in response to TTY (local): (301) 427–1130; Email: health care providers to collect and
this notice will be summarized and PSO@AHRQ.hhs.gov. submit standardized information
included in the Agency’s subsequent regarding patient quality and safety to
SUPPLEMENTARY INFORMATION:
request for OMB approval of the PSOs and other entities. The formats are
proposed information collection. All Background not intended to replace any current
comments will become a matter of The Patient Safety and Quality mandatory reporting system,
public record. Improvement Act of 2005, 42 U.S.C. collaborative/voluntary reporting
Sharon B. Arnold, 299b–21 to b–26, (Patient Safety Act) system, research-related reporting
Acting Director. and the related Patient Safety and system, or other reporting/recording
Quality Improvement Final Rule, 42 system; rather the formats are intended
[FR Doc. 2016–08020 Filed 4–7–16; 8:45 am]
CFR part 3 (Patient Safety Rule), to enhance the ability of health care
BILLING CODE 4160–90–P
published in the Federal Register on providers to report information that is
November 21, 2008, (73 FR 70732– standardized both clinically and
DEPARTMENT OF HEALTH AND 70814), provide for the formation of electronically.
HUMAN SERVICES Patient Safety Organizations (PSOs), In collaboration with the interagency
which collect, aggregate, and analyze Federal Patient Safety Workgroup
Agency for Healthcare Research and confidential information regarding the (PSWG), the National Quality Forum
Quality quality and safety of health care (NQF), and the public, AHRQ has
delivery. The collection of patient safety developed Common Formats for three
Common Formats for Reporting on work product allows the aggregation of settings of care—acute care hospitals,
Health Care Quality and Patient Safety data that help to identify and address nursing homes, and retail pharmacies—
AGENCY: Agency for Healthcare Research underlying causal factors of patient in order to facilitate standardized data
mstockstill on DSK4VPTVN1PROD with NOTICES
and Quality (AHRQ), Department of quality and safety problems. collection and analysis. The scope of the
Health and Human Services (HHS). The Patient Safety Act and Patient formats applies to all patient safety
ACTION: Notice of availability—new Safety Rule establish a framework by concerns including: Incidents—patient
common formats. which doctors, hospitals, skilled safety events that reached the patient,
nursing facilities, and other health care whether or not there was harm; near
SUMMARY: As authorized by the providers may assemble information misses or close calls—patient safety
Secretary of HHS, AHRQ coordinates regarding patient safety events and events that did not reach the patient;
the development of sets of common quality of care. Information that is and unsafe conditions—circumstances
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Document Created: 2018-02-07 13:50:25
Document Modified: 2018-02-07 13:50:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by June 7, 2016. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 81 FR 20640 |
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