[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Notices]
[Pages 27778-27781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12767]


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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 ``Ambulatory Surgery Center Survey on Patient Safety Culture 
Database.''
    This proposed information collection was previously published in 
the Federal Register on March 14th, 2018 and allowed 60 days for public 
comment. AHRQ received no substantive comments from members of the 
public. The purpose of this notice is to allow an additional 30 days 
for public comment.

DATES: Comments on this notice must be received by July 16, 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

Ambulatory Surgery Center Survey on Patient Safety Culture 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. Ambulatory surgery centers (ASCs) are a fast-growing health 
care setting, demonstrating tremendous growth both in the volume and 
complexity of procedures being performed. ASCs provide surgical 
services to patients who are not expected to need an inpatient stay 
following surgery. The Centers for Medicare and Medicaid Services (CMS) 
defines ASCs as distinct entities that operate exclusively to provide 
surgical services to patients who do not require hospitalization and 
are not expected to need to stay in a surgical facility longer than 24 
hours.

[[Page 27779]]

    How AHRQ's Mission and Directives Relate to ASCs. As described in 
its 1999 reauthorizing legislation, Congress directed the Agency for 
Healthcare Research and Quality (AHRQ) to enhance the quality, 
appropriateness, and effectiveness of health services, as well as 
access to such services, by establishing a broad base of scientific 
research and promoting clinical and health systems practice 
improvements. The legislation also directed AHRQ to ``conduct and 
support research, evaluations, and training, support demonstration 
projects, research networks, and multidisciplinary centers, provide 
technical assistance, and disseminate information on health care and on 
systems for the delivery of such care, including activities with 
respect to health statistics, surveys, database development, and 
epidemiology.'' 42 U.S.C. 299a(a)(8).
    Shortly after Congress enacted this legislation, the Institute of 
Medicine (IOM) published ``To Err is Human,'' a seminal report on 
medical errors that connects the dots between errors and workplace 
culture. In it, the IOM called for health care organizations to develop 
a ``culture of safety'' such that staffing and system processes are 
aligned to improve the reliability and safety of patient care. This 
appeal for safety culture improvements directly relates to AHRQ's 
legislative directive and mission (i.e., ``to produce evidence to make 
health care safer, higher quality, more accessible, equitable, and 
affordable, and to work within the U.S. Department of Health and Human 
Services and with other partners to make sure that the evidence is 
understood and used''). Given its legislatively-mandated role, AHRQ is 
uniquely positioned to support data collection and analyses that will 
help fuel ASC patient safety culture improvements. The expanding volume 
and scope of ASC services, the growing attention of federal regulators 
on patient safety within ASCs, and the resultant implications for 
public health has prompted AHRQ to present this application to the 
Office of Management and Budget (OMB). In this request, AHRQ seeks OMB 
approval to expand its Surveys on Patient Safety CultureTM 
(SOPSTM) program by creating an ASC SOPS Database to capture 
and report on ASC SOPS data voluntarily-submitted by ASCs that have 
administered the ASC SOPS. The ASC SOPS Database is the newest database 
for the SOPS program and would be modeled after AHRQ's existing SOPS 
Databases for Hospitals, Medical Offices, Nursing Homes, and Community 
Pharmacies, which have all undergone OMB review and approval.
    Background on ASC SOPS. This section provides context for this 
request to the OMB regarding the need for AHRQ's requested database. 
Factors include the continued ASC growth trajectory and increasing 
public attention on the quality of ASC care--particularly as it relates 
to patient safety culture.
    Rapid ASC Growth. Medicare-certified ASCs have experienced 
impressive growth in the last 35 years--up from 239 facilities in 1983 
to 5,316 in 2010. In recent years, Medicare ASCs have seen continued 
growth in both their number and scope, as illustrated by the annual 
average growth rate of 1.1 percent between 2010 to 2014. In 2015, CMS 
spent $4.1 billion for 3.4 million fee-for service Medicare 
beneficiaries to receive care across 5,500 Medicare-certified ASCs. 
Research suggests that transitioning eligible surgical procedures from 
inpatient to ASC settings may yield significant and sustained Medicare 
cost savings.
    Federal Attention on ASC Care Quality and Safety Culture. Concern 
about the quality of ASC care is not new. Following a 2008 Hepatitis C 
outbreak in Nevada blamed on poor ASC infection control practices, 
HHS's Office of the Secretary oversaw a $10 million program for state 
survey agencies to improve healthcare-associated infection reduction in 
ASCs. The Centers for Disease Control's (CDC) National Healthcare 
Safety Network (NHSN) subsequently expanded its surgical site infection 
(SSI) surveillance efforts to enable ASC data submission to accommodate 
state SSI reporting mandates. Through the Affordable Care Act of 2010, 
Congress also pursued ASC performance improvement by directing the HHS 
Secretary to implement an ASC-focused Medicare value-based purchasing 
(VBP) program.
    The relationship between patient safety culture and the quality of 
ASC care has attracted more recent attention from policymakers and 
regulators. On the national level, the Joint Commission in early 2017 
established within its ASC accreditation manual a new chapter on 
patient safety systems improvement, which includes strategies for 
``motivating staff to uphold a fair and just safety culture.'' CMS, 
meanwhile, published in November 2017 its Final Rule outlining the ASC 
Quality Reporting (ASCQR) Program, which ties quality and patient 
safety performance to reimbursement.
    ASC SOPS Pilot. AHRQ developed and pilot tested the Ambulatory 
Surgery Center Survey on Patient Safety Culture (ASC SOPS) with OMB 
approval (OMB No. 0935-0216; approved 10/31/2013). The survey is 
designed to enable any ASC (regardless of type of procedures it 
performs) to assess their staff's perceptions about patient safety and 
quality assurance issues, including what safety-related attitudes and 
behaviors are supported, rewarded, and expected. It includes 27 items 
that measure 8 composites of patient safety culture, as well as five 
individual items on near-miss documentation, overall rating on patient 
safety and communication in the procedure/surgery room. The pilot test 
was conducted in early 2014 in ASC facilities: (1) Where patients have 
surgeries, procedures, and treatments and are not expected to need an 
inpatient stay, and (2) that have been certified and approved to 
participate in the CMS ASC program. Twenty-five percent of the pilot 
sites were affiliated with a hospital and 75% were not hospital-
affiliated. Participants included 1,800 staff members from 59 ASCs--or 
approximately one percent of the total number of ASCs at that time.
    AHRQ made the survey publicly available along with a Survey User's 
Guide, the pilot study results, and related toolkit materials on the 
AHRQ Ambulatory Surgery Center Survey on Patient Safety Culture Web 
page in April 2015.
    The AHRQ ASC SOPS Database will consist of data from the AHRQ ASC 
patient safety culture survey. ASCs in the U.S. will be asked to 
voluntarily submit data from the survey to AHRQ. The ASC SOPS Database 
will be modeled after four other SOPS databases developed by AHRQ: 
Hospital SOPS [OMB NO. 0935-0162; last approved 10/18/2016]; Medical 
Office SOPS [OMB NO. 0935-0196; last approved 08/25/15]; Nursing Home 
SOPS [OMB NO. 0935-0195; last approved 09/30/15]; and Community 
Pharmacy SOPS [OMB NO. 0935-0218; last approved 06/26/17].
    Rationale for the information collection. AHRQ sponsored the 
development of the ASC SOPS as a new survey in the suite of AHRQ 
Surveys on Patient Safety Culture. The database will support AHRQ's 
goals of promoting improvements in the quality and safety of health 
care in ASC settings. Like the survey and other toolkit materials, the 
database results will be made publicly available on AHRQ's website. 
Technical assistance is provided by AHRQ through its contractor at no 
charge to ASCs to facilitate the use of these materials for ASC patient 
safety and quality improvement. Technical assistance will also be 
provided to support ASC data submission.

[[Page 27780]]

    The goal of this project is to create the ASC SOPS Database. This 
database will:
    (1) Present results from ASCs that voluntarily submit their data;
    (2) Present trend data for ASCs that have submitted their data more 
than once;
    (3) Provide data to ASCs to facilitate internal assessment and 
learning in the patient safety improvement process; and
    (4) Provide supplemental information to help ASCs 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 health statistics, surveys, and database development.. 42 
U.S.C 299a(a)(1) and (8).

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 point-of-contact (POC), 
often the manager of the ASC, completes a number of data submission 
steps and forms, beginning with completion of an online Eligibility and 
Registration Form. The purpose of this form is to collect basic 
demographic information about the ASC and initiate the registration 
process.
    (2) ASC Site Information--The purpose of the site level 
specifications, completed by the ASC manager, is to collect background 
characteristics of the ASC. This information will be used to analyze 
data collected with the ASC SOPS survey.
    (3) Data Use Agreement--The purpose of the data use agreement, 
completed by the ASC manager, is to state how data submitted by ASCs 
will be used and provides privacy assurances.
    (4) Data Files Submission--POCs upload their data file(s), using 
ASC survey 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 ASCs do not administer the survey and submit 
data every year. Data submission is typically handled by one POC who is 
either an ASC administrative manager or a survey vendor who contracts 
with an ASC to collect and submit its data.
    With the approval and addition of the ASC SOPS Database, data from 
the database will be used to produce three types of products:
    (1) An ASC SOPS Database Report that will be made publicly 
available on the AHRQ website (see, for example, another project in the 
SOPS suite, the Hospital User Database Report);
    (2) Individual ASC Survey Feedback Reports that are customized for 
each ASC that submits data to the database; and
    (3) Research data sets of individual-level and ASC-level data to 
enable researchers to conduct analyses. All data released in a data set 
are de-identified at the individual level and the ASC level.
    ASCs will be invited to voluntarily submit their ASC SOPS survey 
data into the database. AHRQ's contractor, Westat, will then clean and 
aggregate the data to produce a PDF-formatted Database Report 
displaying averages, standard deviations, and percentile scores on the 
survey's 33 items and 8 patient safety culture dimensions. In addition, 
the report will also display results by respondent characteristics 
(e.g., staff position, tenure, and hours worked per week).
    The Database Report will include a section on data limitations, 
emphasizing that the report does not reflect a representative sampling 
of the U.S. ASC population. Because participating ASCs will choose to 
voluntarily submit their data into the database and therefore are not a 
random or national sample of ASCs, estimates based on this self-
selected group might be biased estimates. These limitations will be 
noted in the database report. We will recommend that users review the 
database results with these caveats in mind.
    Each ASC that submits its data will receive a customized survey 
feedback report that presents their results alongside the aggregated 
results from other participating ASCs. If an ASC submits data more than 
once, its survey feedback report will also present trend data.
    ASC users of the ASCs SOPS Survey, Database Reports, and Individual 
ASC Survey Feedback Reports can use these documents to:
     Raise staff awareness about patient safety;
     Diagnose and assess the current status of patient safety 
culture in their own ASC;
     Identify strengths and areas for patient safety culture 
improvement;
     Examine trends in patient safety culture change over time; 
and
     Evaluate the cultural impact of patient safety initiatives 
and intervention.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in the database. Given that this will 
be the first call for voluntary data submission, participation is 
initially expected to be modest. An estimated 100 ASC managers (i.e., 
POCs from ASCs) will complete the database submission steps and forms. 
Each POC will submit the following:
     Eligibility and registration form (completion is estimated 
to take about 5 minutes).
     Data use agreement (completion is estimated to take about 
3 minutes).
     ASC Site Information Form (completion is estimated to take 
about 5 minutes).
     Survey data submission will take an average of one hour.
    The total burden is estimated to be 121 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 $5,472.83

                                  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 and Registration Form...............             100               1            5/60               8
Data Use Agreement..............................             100               1            3/60               5
ASC Site Information Form.......................             100               1            5/60               8
Data Files Submission...........................             100               1               1             100
                                                 ---------------------------------------------------------------

[[Page 27781]]

 
    Total.......................................              NA              NA              NA             121
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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 and Registration Form...............             100               8          $45.23         $361.84
Data Use Agreement..............................             100               5           45.23          226.15
ASC Site Information............................             100               8           45.23          361.84
Data Files Submission...........................             100             100           45.23        4,523.00
                                                 ---------------------------------------------------------------
    Total.......................................              NA             121           45.23        5,472.83
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* Based on the mean hourly wage for 100 ASC Administrative Services Managers (11-3011; $45.23) obtained from the
  May 2016 National Industry-Specific Occupational Employment and Wage Estimates: NAICS 621400--Outpatient Care
  Centers (located at http://www.bls.gov/oes/current/naics4_621400.htm#11-0000).

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. 2018-12767 Filed 6-13-18; 8:45 am]
 BILLING CODE 4160-90-P