83_FR_11253 83 FR 11203 - Agency Information Collection Activities: Proposed Collection; Comment Request

83 FR 11203 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 83, Issue 50 (March 14, 2018)

Page Range11203-11206
FR Document2018-05067

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.''

Federal Register, Volume 83 Issue 50 (Wednesday, March 14, 2018)
[Federal Register Volume 83, Number 50 (Wednesday, March 14, 2018)]
[Notices]
[Pages 11203-11206]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05067]


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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.

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

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.''

DATES: Comments on this notice must be received by May 14, 2018.

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

Ambulatory Surgery Center Survey on Patient Safety Culture Database

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, the Agency for Healthcare Research and Quality (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.
    How AHRQ's Mission and Directives Relate to ASCs. As described in 
its 1999 reauthorizing legislation, Congress directed 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 connected 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. This is the 
newest database for the SOPS program and would 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].

[[Page 11204]]

    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 National Healthcare Safety 
Network 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 
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 
within its ASC accreditation manual established 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 Program, which ties quality and patient safety 
performance to reimbursement.
    ASC SOPS Pilot. AHRQ developed and pilot tested the 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 its 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.
    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.
    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 pointofcontact (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

[[Page 11205]]

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 
submit their data voluntarily 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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                  Form name                        Number of       responses per     Hours per     Total burden
                                               respondents/POCs         POC          response          hours
----------------------------------------------------------------------------------------------------------------
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
                                             -------------------------------------------------------------------
    Total...................................                  NA              NA              NA             121
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of       Total burden   Average hourly    Total cost
                  Form name                    respondents/POCs        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
* 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.


[[Page 11206]]


Karen J. Migdail,
Chief of Staff.
[FR Doc. 2018-05067 Filed 3-13-18; 8:45 am]
 BILLING CODE 4160-90-P



                                                                           Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices                                            11203

                                               by small businesses that have merged                    DEPARTMENT OF HEALTH AND                              health services, as well as access to such
                                               with or been acquired by another                        HUMAN SERVICES                                        services, by establishing a broad base of
                                               business. This information is used by                                                                         scientific research and promoting
                                               the SBA, Congress, Federal agencies and                 Agency for Healthcare Research and                    clinical and health systems practice
                                               the general public for various reasons                  Quality                                               improvements. The legislation also
                                               such as determining if agencies are                                                                           directed AHRQ to ‘‘conduct and support
                                                                                                       Agency Information Collection                         research, evaluations, and training,
                                               meeting statutory goals, set-aside
                                                                                                       Activities: Proposed Collection;                      support demonstration projects,
                                               determinations, and market research.                    Comment Request                                       research networks, and
                                               B. Annual Reporting Burden                              AGENCY: Agency for Healthcare Research                multidisciplinary centers, provide
                                                                                                       and Quality, HHS.                                     technical assistance, and disseminate
                                                  An upward adjustment is being made                                                                         information on health care and on
                                               to the estimated annual reporting                       ACTION: Notice.
                                                                                                                                                             systems for the delivery of such care,
                                               burden since the last notice regarding an                                                                     including activities with respect to
                                                                                                       SUMMARY:   This notice announces the
                                               extension for this clearance published                  intention of the Agency for Healthcare                health statistics, surveys, database
                                               on May 4, 2015 in the Federal Register                  Research and Quality (AHRQ) to request                development, and epidemiology.’’ 42
                                               at 80 FR 25293. Based on fiscal year                    that the Office of Management and                     U.S.C. 299a(a)(8).
                                               2017 re-representation modification                     Budget (OMB) approve the proposed                        Shortly after Congress enacted this
                                               data from the Federal Procurement Data                  information collection project                        legislation, the Institute of Medicine
                                               System (FPDS), the number of annual                     ‘‘Ambulatory Surgery Center Survey on                 (IOM) published ‘‘To Err is Human,’’ a
                                               respondents has increased from 1,700 to                 Patient Safety Culture Database.’’                    seminal report on medical errors that
                                               2,200.                                                                                                        connected the dots between errors and
                                                                                                       DATES: Comments on this notice must be
                                                                                                                                                             workplace culture. In it, the IOM called
                                                  Respondents: 2,200.                                  received by May 14, 2018.                             for health care organizations to develop
                                                  Responses per Respondent: 1.                         ADDRESSES: Written comments should                    a ‘‘culture of safety’’ such that staffing
                                                  Total Number of Responses: 2,200.                    be submitted to: Doris Lefkowitz,                     and system processes are aligned to
                                                                                                       Reports Clearance Officer, AHRQ, by                   improve the reliability and safety of
                                                  Hours per Response: 0.5.                             email at doris.lefkowitz@AHRQ.hhs.gov.                patient care. This appeal for safety
                                                  Total Burden Hours: 1,100.                              Copies of the proposed collection                  culture improvements directly relates to
                                                                                                       plans, data collection instruments, and               AHRQ’s legislative directive and
                                               C. Public Comments                                      specific details on the estimated burden              mission (i.e., ‘‘to produce evidence to
                                                 Public comments are particularly                      can be obtained from the AHRQ Reports                 make health care safer, higher quality,
                                               invited on: Whether this collection of                  Clearance Officer.                                    more accessible, equitable, and
                                               information is necessary for the proper                 FOR FURTHER INFORMATION CONTACT:                      affordable, and to work within the U.S.
                                               performance of functions of the FAR,                    Doris Lefkowitz, AHRQ Reports                         Department of Health and Human
                                                                                                       Clearance Officer, (301) 427–1477, or by              Services and with other partners to
                                               and whether it will have practical
                                                                                                       email at doris.lefkowitz@AHRQ.hhs.gov.                make sure that the evidence is
                                               utility; whether our estimate of the
                                                                                                       SUPPLEMENTARY INFORMATION:                            understood and used’’). Given its
                                               public burden of this collection of                                                                           legislatively mandated role, AHRQ is
                                               information is accurate, and based on                   Proposed Project                                      uniquely positioned to support data
                                               valid assumptions and methodology;                                                                            collection and analyses that will help
                                               ways to enhance the quality, utility, and               Ambulatory Surgery Center Survey on
                                                                                                       Patient Safety Culture Database                       fuel ASC patient safety culture
                                               clarity of the information to be                                                                              improvements.
                                               collected; and ways in which we can                       In accordance with the Paperwork                       The expanding volume and scope of
                                               minimize the burden of the collection of                Reduction Act, 44 U.S.C. 3501–3521,                   ASC services, the growing attention of
                                               information on those who are to                         the Agency for Healthcare Research and                federal regulators on patient safety
                                               respond, through the use of appropriate                 Quality (AHRQ) invites the public to                  within ASCs, and the resultant
                                               technological collection techniques or                  comment on this proposed information                  implications for public health has
                                               other forms of information technology.                  collection. Ambulatory surgery centers                prompted AHRQ to present this
                                                                                                       (ASCs) are a fast-growing health care                 application to the Office of Management
                                                 Obtaining Copies of Proposals:                        setting, demonstrating tremendous                     and Budget (OMB). In this request,
                                               Requesters may obtain a copy of the                     growth both in the volume and                         AHRQ seeks OMB approval to expand
                                               information collection documents from                   complexity of procedures being                        its Surveys on Patient Safety CultureTM
                                               the General Services Administration,                    performed. ASCs provide surgical                      (SOPSTM) program by creating an ASC
                                               Regulatory Secretariat Division (MVCB),                 services to patients who are not                      SOPS Database to capture and report on
                                               1800 F Street NW, Washington, DC                        expected to need an inpatient stay                    ASC SOPS data voluntarily submitted
                                               20405, telephone 202–501–4755.                          following surgery. The Centers for                    by ASCs that have administered the
                                                 Please cite OMB Control No. 9000–                     Medicare and Medicaid Services (CMS)                  ASC SOPS. This is the newest database
                                               0163, Small Business Size Re-                           defines ASCs as distinct entities that                for the SOPS program and would be
                                               representation, in all correspondence.                  operate exclusively to provide surgical               modeled after four other SOPS
                                                                                                       services to patients who do not require               databases developed by AHRQ: Hospital
                                                 Dated: March 7, 2018.
                                                                                                       hospitalization and are not expected to               SOPS [OMB NO. 0935–0162; last
daltland on DSKBBV9HB2PROD with NOTICES




                                               Lorin S. Curit,                                         need to stay in a surgical facility longer            approved 10/18/2016]; Medical Office
                                               Director, Federal Acquisition Policy Division,          than 24 hours.                                        SOPS [OMB NO. 0935–0196; last
                                               Office of Governmentwide Acquisition Policy,              How AHRQ’s Mission and Directives                   approved 08/25/15]; Nursing Home
                                               Office of Acquisition Policy, Office of                 Relate to ASCs. As described in its 1999              SOPS [OMB NO. 0935–0195; last
                                               Governmentwide Policy.                                  reauthorizing legislation, Congress                   approved 09/30/15]; and Community
                                               [FR Doc. 2018–05066 Filed 3–13–18; 8:45 am]             directed AHRQ to enhance the quality,                 Pharmacy SOPS [OMB NO. 0935–0218;
                                               BILLING CODE 6820–EP–P                                  appropriateness, and effectiveness of                 last approved 06/26/17].


                                          VerDate Sep<11>2014   18:17 Mar 13, 2018   Jkt 244001   PO 00000   Frm 00036   Fmt 4703   Sfmt 4703   E:\FR\FM\14MRN1.SGM   14MRN1


                                               11204                       Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices

                                                  Background on ASC SOPS. This                         of type of procedures it performs, to                    This study is being conducted by
                                               section provides context for this request               assess its staff’s perceptions about                  AHRQ through its contractor, Westat,
                                               to the OMB regarding the need for                       patient safety and quality assurance                  pursuant to AHRQ’s statutory authority
                                               AHRQ’s requested database. Factors                      issues, including what safety-related                 to conduct and support research on
                                               include the continued ASC growth                        attitudes and behaviors are supported,                health care and on systems for the
                                               trajectory and increasing public                        rewarded, and expected. It includes 27                delivery of such care, including
                                               attention on the quality of ASC care—                   items that measure 8 composites of                    activities with respect to the quality,
                                               particularly as it relates to patient safety            patient safety culture, as well as five               effectiveness, efficiency,
                                               culture.                                                individual items on near-miss                         appropriateness and value of health care
                                                  Rapid ASC Growth. Medicare-                          documentation, overall rating on patient              services and with respect to health
                                               certified ASCs have experienced                         safety and communication in the                       statistics, surveys, and database
                                               impressive growth in the last 35 years—                 procedure/surgery room. The pilot test                development. 42 U.S.C. 299a(a)(1) and
                                               up from 239 facilities in 1983 to 5,316                 was conducted in early 2014 in ASC                    (8).
                                               in 2010. In recent years, Medicare ASCs                 facilities: (1) Where patients have
                                               have seen continued growth in both                                                                            Method of Collection
                                                                                                       surgeries, procedures, and treatments
                                               their number and scope, as illustrated                  and are not expected to need an                          To achieve the goal of this project the
                                               by the annual average growth rate of 1.1                inpatient stay, and (2) that have been                following activities and data collections
                                               percent between 2010 to 2014. In 2015,                  certified and approved to participate in              will be implemented:
                                               CMS spent $4.1 billion for 3.4 million                  the CMS ASC program. Twenty-five                         (1) Eligibility and Registration Form—
                                               fee-for service Medicare beneficiaries to               percent of the pilot sites were affiliated            The pointofcontact (POC), often the
                                               receive care across 5,500 Medicare-                     with a hospital and 75% were not                      manager of the ASC, completes a
                                               certified ASCs. Research suggests that                  hospital-affiliated. Participants included            number of data submission steps and
                                               transitioning eligible surgical                         1,800 staff members from 59 ASCs—or                   forms, beginning with completion of an
                                               procedures from inpatient to ASC                        approximately one percent of the total                online Eligibility and Registration Form.
                                               settings may yield significant and                      number of ASCs at that time.                          The purpose of this form is to collect
                                               sustained Medicare cost savings.                                                                              basic demographic information about
                                                  Federal Attention on ASC Care                           AHRQ made the survey publicly
                                                                                                       available along with a Survey User’s                  the ASC and initiate the registration
                                               Quality and Safety Culture. Concern                                                                           process.
                                               about the quality of ASC care is not                    Guide, the pilot study results, and
                                                                                                                                                                (2) ASC Site Information—The
                                               new. Following a 2008 Hepatitis C                       related toolkit materials on the AHRQ
                                                                                                                                                             purpose of the site level specifications,
                                               outbreak in Nevada blamed on poor                       Ambulatory Surgery Center Survey on
                                                                                                                                                             completed by the ASC manager, is to
                                               ASC infection control practices, HHS’s                  Patient Safety Culture Web page in
                                                                                                                                                             collect background characteristics of the
                                               Office of the Secretary oversaw a $10                   April 2015. The AHRQ ASC SOPS
                                                                                                                                                             ASC. This information will be used to
                                               million program for state survey                        Database will consist of data from the
                                                                                                                                                             analyze data collected with the ASC
                                               agencies to improve healthcare-                         AHRQ ASC patient safety culture
                                                                                                                                                             SOPS survey.
                                               associated infection reduction in ASCs.                 survey. ASCs in the U.S. will be asked
                                                                                                                                                                (3) Data Use Agreement—The
                                               The Centers for Disease Control’s                       to voluntarily submit data from the
                                                                                                                                                             purpose of the data use agreement,
                                               National Healthcare Safety Network                      survey to AHRQ.
                                                                                                                                                             completed by the ASC manager, is to
                                               subsequently expanded its surgical site                    Rationale for the information                      state how data submitted by ASCs will
                                               infection (SSI) surveillance efforts to                 collection. AHRQ sponsored the                        be used and provides privacy
                                               enable ASC data submission to                           development of the ASC SOPS as a new                  assurances.
                                               accommodate state SSI reporting                         survey in the suite of AHRQ Surveys on                   (4) Data Files Submission—POCs
                                               mandates. Through the Affordable Care                   Patient Safety Culture. The database                  upload their data file(s), using ASC
                                               Act of 2010, Congress also pursued ASC                  will support AHRQ’s goals of promoting                survey data file specifications, to ensure
                                               performance improvement by directing                    improvements in the quality and safety                that users submit standardized and
                                               the HHS Secretary to implement an                       of health care in ASC settings. Like the              consistent data in the way variables are
                                               ASC-focused Medicare value-based                        survey and other toolkit materials, the               named, coded, and formatted. The
                                               purchasing program.                                     database results will be made publicly                number of submissions to the database
                                                  The relationship between patient                     available on AHRQ’s website. Technical                is likely to vary each year because ASCs
                                               safety culture and the quality of ASC                   assistance is provided by AHRQ through                do not administer the survey and submit
                                               care has attracted more recent attention                its contractor at no charge to ASCs to                data every year. Data submission is
                                               from policymakers and regulators. On                    facilitate the use of these materials for             typically handled by one POC who is
                                               the national level, the Joint Commission                ASC patient safety and quality                        either an ASC administrative manager
                                               in early 2017 within its ASC                            improvement. Technical assistance will                or a survey vendor who contracts with
                                               accreditation manual established a new                  also be provided to support ASC data                  an ASC to collect and submit its data.
                                               chapter on patient safety systems                       submission.                                              With the approval and addition of the
                                               improvement, which includes strategies
                                                                                                          The goal of this project is to create the          ASC SOPS Database, data from the
                                               for ‘‘motivating staff to uphold a fair and
                                                                                                       ASC SOPS Database. This database will:                database will be used to produce three
                                               just safety culture.’’ CMS, meanwhile,
                                                                                                         (1) Present results from ASCs that
                                                                                                                                                             types of products:
                                               published in November 2017 its Final
                                               Rule outlining the ASC Quality                          voluntarily submit their data;                          (1) An ASC SOPS Database Report that will
                                               Reporting Program, which ties quality                     (2) Present trend data for ASCs that have           be made publicly available on the AHRQ
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                                               and patient safety performance to                       submitted their data more than once;                  website (see, for example, another project in
                                                                                                         (3) Provide data to ASCs to facilitate              the SOPS suite, the Hospital User Database
                                               reimbursement.                                          internal assessment and learning in the               Report);
                                                  ASC SOPS Pilot. AHRQ developed                       patient safety improvement process; and                 (2) Individual ASC Survey Feedback
                                               and pilot tested the ASC SOPS with                        (4) Provide supplemental information to             Reports that are customized for each ASC
                                               OMB approval (OMB No. 0935–0216;                        help ASCs identify their strengths and areas          that submits data to the database; and
                                               approved 10/31/2013). The survey is                     with potential for improvement in patient               (3) Research data sets of individual-level
                                               designed to enable any ASC, regardless                  safety culture.                                       and ASC-level data to enable researchers to



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                                                                                     Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices                                                                  11205

                                               conduct analyses. All data released in a data                              database results with these caveats in                         respondents’ time to participate in the
                                               set are de-identified at the individual level                              mind.                                                          database. Given that this will be the first
                                               and the ASC level.                                                           Each ASC that submits its data will                          call for voluntary data submission,
                                                  ASCs will be invited to voluntarily                                     receive a customized survey feedback                           participation is initially expected to be
                                               submit their ASC SOPS survey data into                                     report that presents their results                             modest. An estimated 100 ASC
                                               the database. AHRQ’s contractor,                                           alongside the aggregated results from                          managers (i.e., POCs from ASCs) will
                                               Westat, will then clean and aggregate                                      other participating ASCs. If an ASC                            complete the database submission steps
                                               the data to produce a PDF-formatted                                        submits data more than once, its survey                        and forms. Each POC will submit the
                                               Database Report displaying averages,                                       feedback report will also present trend
                                                                                                                                                                                         following:
                                               standard deviations, and percentile                                        data.
                                               scores on the survey’s 33 items and 8                                        ASC users of the ASCs SOPS Survey,                             • Eligibility and registration form
                                               patient safety culture dimensions. In                                      Database Reports, and Individual ASC                           (completion is estimated to take about 5
                                               addition, the report will also display                                     Survey Feedback Reports can use these                          minutes).
                                               results by respondent characteristics                                      documents to:                                                    • Data use agreement (completion is
                                               (e.g., staff position, tenure, and hours                                     • Raise staff awareness about patient                        estimated to take about 3 minutes).
                                               worked per week).                                                          safety;
                                                                                                                            • Diagnose and assess the current                              • ASC Site Information Form
                                                  The Database Report will include a                                                                                                     (completion is estimated to take about 5
                                                                                                                          status of patient safety culture in their
                                               section on data limitations, emphasizing                                                                                                  minutes).
                                                                                                                          own ASC;
                                               that the report does not reflect a                                           • Identify strengths and areas for
                                               representative sampling of the U.S. ASC                                                                                                     • Survey data submission will take an
                                                                                                                          patient safety culture improvement;                            average of one hour.
                                               population. Because participating ASCs                                       • Examine trends in patient safety
                                               will choose to submit their data                                           culture change over time; and                                    The total burden is estimated to be
                                               voluntarily into the database and                                            • Evaluate the cultural impact of                            121 hours.
                                               therefore are not a random or national                                     patient safety initiatives and                                   Exhibit 2 shows the estimated
                                               sample of ASCs, estimates based on this                                    intervention.                                                  annualized cost burden based on the
                                               self-selected group might be biased
                                                                                                                          Estimated Annual Respondent Burden                             respondents’ time to submit their data.
                                               estimates. These limitations will be
                                               noted in the database report. We will                                        Exhibit 1 shows the estimated                                The cost burden is estimated to be
                                               recommend that users review the                                            annualized burden hours for the                                $5,472.83.

                                                                                                              EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                        Number of
                                                                                                                                                                    Number of                               Hours per     Total burden
                                                                                            Form name                                                                                   responses
                                                                                                                                                                respondents/POCs                            response         hours
                                                                                                                                                                                         per POC

                                               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

                                                     Total ..................................................................................................                    NA                NA               NA             121


                                                                                                               EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
                                                                                                                                                                                                             Average
                                                                                                                                                                    Number of              Total                           Total cost
                                                                                            Form name                                                                                                      hourly wage
                                                                                                                                                                respondents/POCs       burden hours                         burden
                                                                                                                                                                                                              rate *

                                               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
                                                 * Based on the mean hourly wage for 100 ASC Administrative Services Managers (11–3011; $45.23) obtained from the May 2016 National In-
                                               dustry-Specific Occupational Employment and Wage Estimates: NAICS 621400—Outpatient Care Centers (located at http://www.bls.gov/oes/cur-
                                               rent/naics4_621400.htm#11-0000).


                                               Request for Comments                                                       whether the information will have                              automated collection techniques or
                                                                                                                          practical utility; (b) the accuracy of                         other forms of information technology.
                                                 In accordance with the Paperwork
                                                                                                                          AHRQ’s estimate of burden (including                             Comments submitted in response to
                                               Reduction Act, comments on AHRQ’s
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                                                                                                                          hours and costs) of the proposed                               this notice will be summarized and
                                               information collection are requested
                                               with regard to any of the following: (a)                                   collection(s) of information; (c) ways to                      included in the Agency’s subsequent
                                               Whether the proposed collection of                                         enhance the quality, utility and clarity                       request for OMB approval of the
                                               information is necessary for the proper                                    of the information to be collected; and                        proposed information collection. All
                                               performance of AHRQ’s health care                                          (d) ways to minimize the burden of the                         comments will become a matter of
                                               research and health care information                                       collection of information upon the                             public record.
                                               dissemination functions, including                                         respondents, including the use of


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                                               11206                       Federal Register / Vol. 83, No. 50 / Wednesday, March 14, 2018 / Notices

                                               Karen J. Migdail,                                       instruments, call (404) 639–7570 or                   representative survey data will allow us
                                               Chief of Staff.                                         send an email to omb@cdc.gov. Direct                  to generalize findings to the full
                                               [FR Doc. 2018–05067 Filed 3–13–18; 8:45 am]             written comments and/or suggestions                   population of LHDs in the U.S.
                                               BILLING CODE 4160–90–P                                  regarding the items contained in this                    CDC requests approval of a new
                                                                                                       notice to the Attention: CDC Desk                     information collection to learn about
                                                                                                       Officer, Office of Management and                     how the emerging field of disaster
                                               DEPARTMENT OF HEALTH AND                                Budget, 725 17th Street NW,                           citizen science can enhance community
                                               HUMAN SERVICES                                          Washington, DC 20503 or by fax to (202)               resilience for a period of 1 year. This
                                                                                                       395–5806. Provide written comments                    (mixed methods) information collection
                                               Centers for Disease Control and                         within 30 days of notice publication.                 using interviews and a cross-sectional
                                               Prevention                                                                                                    survey aims to: (1) Explore the potential
                                                                                                       Proposed Project                                      of disaster citizen science for increasing
                                               [30Day–18–17AVB]
                                                                                                         Leveraging the Emerging Field of                    community resilience, enhancing
                                               Agency Forms Undergoing Paperwork                       Disaster Citizen Science to Enhance                   participation in preparedness and
                                               Reduction Act Review                                    Community Resilience and Improve                      response activities, and improving
                                                                                                       Disaster Response—New—Office of                       preparedness efforts; and (2) provide
                                                  In accordance with the Paperwork                     Public Health Preparedness and                        evidence to inform the development of
                                               Reduction Act of 1995, the Centers for                  Response (OPHPR), Centers for Disease                 educational and instructional tools for
                                               Disease Control and Prevention (CDC)                    Control and Prevention (CDC).                         communities and health departments to
                                               has submitted the information                                                                                 navigate the emerging field of disaster
                                                                                                       Background and Brief Description
                                               collection request titled ‘‘Leveraging the                                                                    citizen science and promote
                                               Emerging Field of Disaster Citizen                         The information collection for which               collaborations. Insights from this
                                               Science to Enhance Community                            approval is sought is in accordance with              information collection will be used to
                                               Resilience and Improve Disaster                         OPHPR’s mission to safeguard health                   inform the development of guidance
                                               Response’’ to the Office of Management                  and save lives by providing a platform                and toolkits for LHDs and community
                                               and Budget (OMB) for review and                         for public health preparedness and                    groups so that they can align their
                                               approval. CDC previously published a                    emergency response. As part of its role,              efforts and strengthen the benefits and
                                               ‘‘Proposed Data Collection Submitted                    OPHPR is empowered to fund applied                    positive impacts of citizen science
                                               for Public Comment and                                  research to improve the ability of CDC                activities. For interviews, the
                                               Recommendations’’ notice on                             and its partners, including but not                   information collection will target citizen
                                               September 19, 2017 to obtain comments                   limited to state and local health                     scientists and end users of citizen
                                               from the public and affected agencies.                  departments, emergency management                     science data.
                                               CDC did not receive comments related                    organizations, and health care entities,                 This information collection will be
                                               to the previous notice. This notice                     to effectively prepare for and respond to             implemented in collaboration with a
                                               serves to allow an additional 30 days for               public health emergencies and disasters.              contractor and will target citizen
                                               public and affected agency comments.                       Citizen science is defined as research             scientists and their partners (e.g.,
                                                  CDC will accept all comments for this                activities (e.g., data collection, analysis,          academics who work with citizen
                                               proposed information collection project.                and reporting) performed by members of                scientists on research projects) and
                                               The Office of Management and Budget                     the general public without any                        LHDs in a position to use citizen science
                                               is particularly interested in comments                  particular training in science. Citizen               data to inform public health decision-
                                               that:                                                   science is growing in popularity, fueled              making. For interviews, researchers will
                                                  (a) Evaluate whether the proposed                    in part by growing use of smartphones                 sample for maximum variation, seeking
                                               collection of information is necessary                  and other personal devices in the                     to obtain variation on U.S. region, type
                                               for the proper performance of the                       population. Although citizen collection               and sophistication of citizen science
                                               functions of the agency, including                      and use of data during disasters has                  project, type of disaster encountered,
                                               whether the information will have                       increased exponentially in recent years               and previous experience with disaster
                                               practical utility;                                      and there is great policy interest in the             citizen science.
                                                  (b) Evaluate the accuracy of the                     phenomenon, there has been no robust                     The project aims to conduct 35–55
                                               agencies estimate of the burden of the                  research to date on the use of, barriers              facilitated, semi-structured, individual
                                               proposed collection of information,                     to, and impact of citizen science in                  and group interviews, each lasting
                                               including the validity of the                           disasters. Local health departments                   approximately 60 minutes, to cover
                                               methodology and assumptions used;                       (LHDs) lack tools to respond to and                   topics including benefits and uses of
                                                  (c) Enhance the quality, utility, and                coordinate with citizen science                       citizen science, barriers to and
                                               clarity of the information to be                        activities within communities.                        facilitators of citizen science, and
                                               collected;                                              Furthermore, citizen science                          strengths and limitations of citizen
                                                  (d) Minimize the burden of the                       organizations lack information on how                 science activities and resources.
                                               collection of information on those who                  to organize their activities for ultimate                Researchers will identify potential
                                               are to respond, including, through the                  impact.                                               interview participants through literature
                                               use of appropriate automated,                              This is an exploratory study and is the            reviews and snowball sampling in a
                                               electronic, mechanical, or other                        first of its kind to explore the growing              phased approach starting with citizen
                                               technological collection techniques or                  phenomenon of disaster citizen science.               science and LHD organizations.
                                               other forms of information technology,                  Disaster citizen science is a rapidly                    The project will sample for maximum
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                                               e.g., permitting electronic submission of               growing field that is the focus of policy             variation in order to capture the full
                                               responses; and                                          interest, but currently devoid of                     range of citizen scientist and health
                                                  (e) Assess information collection                    research. While interviews will be                    department experiences on this topic.
                                               costs.                                                  hypothesis generating and provide rich                For the survey, the project aims to
                                                  To request additional information on                 data on the experiences with citizen                  obtain a nationally representative
                                               the proposed project or to obtain a copy                science to date across all stakeholders               sample of 600 local health officials and
                                               of the information collection plan and                  active in this enterprise, the nationally-            will apply survey weights to ensure that


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Document Created: 2018-03-14 01:06:43
Document Modified: 2018-03-14 01:06:43
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this notice must be received by May 14, 2018.
ContactDoris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected]
FR Citation83 FR 11203 

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