83 FR 27778 - 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 115 (June 14, 2018)
Agency for Healthcare Research and Quality
Federal Register Volume 83, Issue 115 (June 14, 2018)
| Page Range | 27778-27781 | |
| FR Document | 2018-12767 |
[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)] [Notices] [Pages 27778-27781] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12767] ======================================================================= ----------------------------------------------------------------------- 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.'' 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 ---------------------------------------------------------------------------------------------------------------- Number of Number of Form name respondents/ responses per Hours per Total burden 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 --------------------------------------------------------------- [[Page 27781]] Total....................................... NA NA NA 121 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Number of Form name respondents/ Total burden Average hourly Total cost 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. Francis D. Chesley, Jr., Acting Deputy Director. [FR Doc. 2018-12767 Filed 6-13-18; 8:45 am] BILLING CODE 4160-90-P
![27778 Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices
proprietary, competitively sensitive not intended to constitute an official DEPARTMENT OF HEALTH AND
information of a rival SRM supplier interpretation of the proposed Consent HUMAN SERVICES
supporting Northrop’s missile system Agreement or to modify its terms in any
business could be transferred to way. Agency for Healthcare Research and
Northrop’s vertically integrated SRM By direction of the Commission.
Quality
business. Janice Frankle, Agency Information Collection
VI. The Consent Agreement Acting Secretary. Activities: Proposed Collection;
The Consent Agreement remedies the [FR Doc. 2018–12750 Filed 6–13–18; 8:45 am] Comment Request
acquisition’s likely anticompetitive BILLING CODE 6750–01–P
effects by requiring, whenever Northrop AGENCY: Agency for Healthcare Research
competes for a missile system prime and Quality, HHS.
contract, that Northrop must make its ACTION: Notice.
SRM products and related services GOVERNMENT ACCOUNTABILITY
available on a non-discriminatory basis OFFICE SUMMARY: This notice announces the
to all other third-party competing prime intention of the Agency for Healthcare
contractors that wish to purchase them. Request for Nominations for the Research and Quality (AHRQ) to request
The non-discrimination prohibitions of Physician-Focused Payment Model that the Office of Management and
the Consent Agreement are Technical Advisory Committee (PTAC) Budget (OMB) approve the proposed
comprehensive and apply to any information collection project
potential discriminatory conduct AGENCY: Government Accountability ‘‘Ambulatory Surgery Center Survey on
affecting price, schedule, quality, data, Office (GAO). Patient Safety Culture Database.’’
personnel, investment, technology, ACTION:Request for letters of This proposed information collection
innovation, design, or risk. nomination and resumes. was previously published in the Federal
The Consent Agreement requires Register on March 14th, 2018 and
Northrop to establish firewalls to ensure SUMMARY: The Medicare Access and allowed 60 days for public comment.
that Northrop does not transfer or use CHIP Reauthorization Act of 2015 AHRQ received no substantive
any proprietary information that it established the Physician-Focused comments from members of the public.
receives from competing missile prime Payment Model Technical Advisory The purpose of this notice is to allow an
contractors or SRM suppliers in a Committee to provide comments and additional 30 days for public comment.
manner that harms competition. These recommendations to the Secretary of DATES: Comments on this notice must be
firewall provisions require that Health and Human Services on received by July 16, 2018.
Northrop maintain separate firewalled physician payment models, and gave ADDRESSES: Written comments should
teams to support offers of SRMs to the Comptroller General responsibility
different third-party missile prime be submitted to: AHRQ’s OMB Desk
for appointing its members. GAO is now Officer by fax at (202) 395–6974
contractors and to maintain these accepting nominations of individuals
firewalled teams separate from the team (attention: AHRQ’s desk officer) or by
for this committee. email at OIRA_submission@
supporting Northrop’s missile prime
contractor activities. The firewall DATES: Letters of nomination and omb.eop.gov (attention: AHRQ’s desk
provisions also prohibit Northrop’s resumes should be submitted no later officer).
missile business from sharing than July 20, 2018, to ensure adequate FOR FURTHER INFORMATION CONTACT:
proprietary information it may receive opportunity for review and Doris Lefkowitz, AHRQ Reports
from third-party SRM suppliers with consideration of nominees prior to Clearance Officer, (301) 427–1477, or by
Northrop’s SRM business. appointment. Appointments will be email at doris.lefkowitz@AHRQ.hhs.gov.
The Consent Agreement also provides made in October 2018.
SUPPLEMENTARY INFORMATION:
that the DOD’s Under Secretary of ADDRESSES: Submit letters of
Defense for Acquisition and Proposed Project
nomination and resumes by either of the
Sustainment shall appoint a compliance following methods: Email: Ambulatory Surgery Center Survey on
officer to oversee Northrop’s compliance PTACcommittee@gao.gov. Include Patient Safety Culture Database
with the Order. The compliance officer PTAC Nominations in the subject line of
will have all the necessary investigative In accordance with the Paperwork
the message, or Mail: U.S. GAO, Attn:
powers to perform his or her duties, Reduction Act, 44 U.S.C. 3501–3521,
PTAC Nominations, 441 G Street NW,
including the right to interview AHRQ invites the public to comment on
Washington, DC 20548.
respondent’s personnel, inspect this proposed information collection.
respondent’s facilities, and require FOR FURTHER INFORMATION CONTACT: Greg Ambulatory surgery centers (ASCs) are
respondents to provide documents, Giusto at (202) 512–8268 or giustog@ a fast-growing health care setting,
data, and other information. The gao.gov if you do not receive an demonstrating tremendous growth both
compliance officer has the authority to acknowledgement within a week of in the volume and complexity of
retain third-party advisors, at the submission or if you need additional procedures being performed. ASCs
expense of Northrop, as appropriate to information. For general information, provide surgical services to patients
perform his or her duties. Access to contact GAO’s Office of Public Affairs, who are not expected to need an
these extensive resources will ensure (202) 512–4800. inpatient stay following surgery. The
daltland on DSKBBV9HB2PROD with NOTICES
that the compliance officer is fully Authority: Pub. L. 114–10, Sec. 101(e), 129 Centers for Medicare and Medicaid
capable of overseeing the Stat. 87, 115 (2015). Services (CMS) defines ASCs as distinct
implementation of, and compliance entities that operate exclusively to
with, the Order. Gene L. Dodaro, provide surgical services to patients
The purpose of this analysis is to Comptroller General of the United States. who do not require hospitalization and
facilitate public comment on the [FR Doc. 2018–12736 Filed 6–13–18; 8:45 am] are not expected to need to stay in a
proposed Consent Agreement, and it is BILLING CODE 1610–02–P surgical facility longer than 24 hours.
VerDate Sep<11>2014 16:38 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/83_FR_27893/page/1.svg)
![Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 27779
How AHRQ’s Mission and Directives which have all undergone OMB review (ASC SOPS) with OMB approval (OMB
Relate to ASCs. As described in its 1999 and approval. No. 0935–0216; approved 10/31/2013).
reauthorizing legislation, Congress Background on ASC SOPS. This The survey is designed to enable any
directed the Agency for Healthcare section provides context for this request ASC (regardless of type of procedures it
Research and Quality (AHRQ) to to the OMB regarding the need for performs) to assess their staff’s
enhance the quality, appropriateness, AHRQ’s requested database. Factors perceptions about patient safety and
and effectiveness of health services, as include the continued ASC growth quality assurance issues, including what
well as access to such services, by trajectory and increasing public safety-related attitudes and behaviors
establishing a broad base of scientific attention on the quality of ASC care— are supported, rewarded, and expected.
research and promoting clinical and particularly as it relates to patient safety It includes 27 items that measure 8
health systems practice improvements. culture. composites of patient safety culture, as
The legislation also directed AHRQ to Rapid ASC Growth. Medicare- well as five individual items on near-
‘‘conduct and support research, certified ASCs have experienced miss documentation, overall rating on
evaluations, and training, support impressive growth in the last 35 years— patient safety and communication in the
demonstration projects, research up from 239 facilities in 1983 to 5,316 procedure/surgery room. The pilot test
networks, and multidisciplinary centers, in 2010. In recent years, Medicare ASCs was conducted in early 2014 in ASC
provide technical assistance, and have seen continued growth in both facilities: (1) Where patients have
disseminate information on health care their number and scope, as illustrated surgeries, procedures, and treatments
and on systems for the delivery of such by the annual average growth rate of 1.1 and are not expected to need an
care, including activities with respect to percent between 2010 to 2014. In 2015, inpatient stay, and (2) that have been
health statistics, surveys, database CMS spent $4.1 billion for 3.4 million certified and approved to participate in
development, and epidemiology.’’ 42 fee-for service Medicare beneficiaries to the CMS ASC program. Twenty-five
U.S.C. 299a(a)(8). receive care across 5,500 Medicare- percent of the pilot sites were affiliated
certified ASCs. Research suggests that with a hospital and 75% were not
Shortly after Congress enacted this transitioning eligible surgical
legislation, the Institute of Medicine hospital-affiliated. Participants included
procedures from inpatient to ASC 1,800 staff members from 59 ASCs—or
(IOM) published ‘‘To Err is Human,’’ a settings may yield significant and approximately one percent of the total
seminal report on medical errors that sustained Medicare cost savings. number of ASCs at that time.
connects the dots between errors and Federal Attention on ASC Care AHRQ made the survey publicly
workplace culture. In it, the IOM called Quality and Safety Culture. Concern available along with a Survey User’s
for health care organizations to develop about the quality of ASC care is not Guide, the pilot study results, and
a ‘‘culture of safety’’ such that staffing new. Following a 2008 Hepatitis C related toolkit materials on the AHRQ
and system processes are aligned to outbreak in Nevada blamed on poor Ambulatory Surgery Center Survey on
improve the reliability and safety of ASC infection control practices, HHS’s Patient Safety Culture Web page in
patient care. This appeal for safety Office of the Secretary oversaw a $10 April 2015.
culture improvements directly relates to million program for state survey The AHRQ ASC SOPS Database will
AHRQ’s legislative directive and agencies to improve healthcare- consist of data from the AHRQ ASC
mission (i.e., ‘‘to produce evidence to associated infection reduction in ASCs. patient safety culture survey. ASCs in
make health care safer, higher quality, The Centers for Disease Control’s (CDC) the U.S. will be asked to voluntarily
more accessible, equitable, and National Healthcare Safety Network submit data from the survey to AHRQ.
affordable, and to work within the U.S. (NHSN) subsequently expanded its The ASC SOPS Database will be
Department of Health and Human surgical site infection (SSI) surveillance modeled after four other SOPS
Services and with other partners to efforts to enable ASC data submission to databases developed by AHRQ: Hospital
make sure that the evidence is accommodate state SSI reporting SOPS [OMB NO. 0935–0162; last
understood and used’’). Given its mandates. Through the Affordable Care approved 10/18/2016]; Medical Office
legislatively-mandated role, AHRQ is Act of 2010, Congress also pursued ASC SOPS [OMB NO. 0935–0196; last
uniquely positioned to support data performance improvement by directing approved 08/25/15]; Nursing Home
collection and analyses that will help the HHS Secretary to implement an SOPS [OMB NO. 0935–0195; last
fuel ASC patient safety culture ASC-focused Medicare value-based approved 09/30/15]; and Community
improvements. The expanding volume purchasing (VBP) program. Pharmacy SOPS [OMB NO. 0935–0218;
and scope of ASC services, the growing The relationship between patient last approved 06/26/17].
attention of federal regulators on patient safety culture and the quality of ASC Rationale for the information
safety within ASCs, and the resultant care has attracted more recent attention collection. AHRQ sponsored the
implications for public health has from policymakers and regulators. On development of the ASC SOPS as a new
prompted AHRQ to present this the national level, the Joint Commission survey in the suite of AHRQ Surveys on
application to the Office of Management in early 2017 established within its ASC Patient Safety Culture. The database
and Budget (OMB). In this request, accreditation manual a new chapter on will support AHRQ’s goals of promoting
AHRQ seeks OMB approval to expand patient safety systems improvement, improvements in the quality and safety
its Surveys on Patient Safety CultureTM which includes strategies for of health care in ASC settings. Like the
(SOPSTM) program by creating an ASC ‘‘motivating staff to uphold a fair and survey and other toolkit materials, the
SOPS Database to capture and report on just safety culture.’’ CMS, meanwhile, database results will be made publicly
ASC SOPS data voluntarily-submitted published in November 2017 its Final available on AHRQ’s website. Technical
daltland on DSKBBV9HB2PROD with NOTICES
by ASCs that have administered the Rule outlining the ASC Quality assistance is provided by AHRQ through
ASC SOPS. The ASC SOPS Database is Reporting (ASCQR) Program, which ties its contractor at no charge to ASCs to
the newest database for the SOPS quality and patient safety performance facilitate the use of these materials for
program and would be modeled after to reimbursement. ASC patient safety and quality
AHRQ’s existing SOPS Databases for ASC SOPS Pilot. AHRQ developed improvement. Technical assistance will
Hospitals, Medical Offices, Nursing and pilot tested the Ambulatory Surgery also be provided to support ASC data
Homes, and Community Pharmacies, Center Survey on Patient Safety Culture submission.
VerDate Sep<11>2014 16:38 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/83_FR_27893/page/2.svg)
![Federal Register / Vol. 83, No. 115 / Thursday, June 14, 2018 / Notices 27781
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of Number of Hours per Total burden
Form name respondents/ responses per response hours
POCs POC
Total .......................................................................................................... NA NA NA 121
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of Average
Total burden Total cost
Form name respondents/ hourly wage
hours burden
POCs 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 DEPARTMENT OF HEALTH AND research programs focused on miner
HUMAN SERVICES health and safety issues. The site being
In accordance with the Paperwork considered for acquisition and
Reduction Act, comments on AHRQ’s Centers for Disease Control and development includes 461.35 acres
information collection are requested Prevention located off of U.S. Route 219 in
with regard to any of the following: (a) Randolph and Pocahontas Counties near
[Docket No. CDC–2018–0057]
Whether the proposed collection of Mace, West Virginia.
information is necessary for the proper Notice of Intent To Prepare an This notice is pursuant to the
performance of AHRQ’s health care Environmental Impact Statement, requirements of the National
research and health care information Public Scoping Meeting, and Request Environmental Policy Act of 1969
dissemination functions, including for Comments; Acquisition of Site for (NEPA) as implemented by the Council
whether the information will have on Environmental Quality (CEQ)
Development of a Replacement
practical utility; (b) the accuracy of Regulations (40 CFR parts 1500–1508).
Underground Safety Research
AHRQ’s estimate of burden (including CDC, in cooperation with GSA, also
Program Facility for the Centers for
hours and costs) of the proposed intends to initiate consultation, as
Disease Control and Prevention/
collection(s) of information; (c) ways to required by Section 106 of the National
National Institute for Occupational
Historic Preservation Act (NHPA), to
enhance the quality, utility and clarity Safety and Health (CDC/NIOSH) in
evaluate the potential effects, if any, of
of the information to be collected; and Mace, West Virginia
the Proposed Action on historic
(d) ways to minimize the burden of the properties. Following the scoping
AGENCY: Centers for Disease Control and
collection of information upon the meeting, a Draft EIS will be prepared
Prevention (CDC), Department of Health
respondents, including the use of and Human Services (HHS) and circulated for public comment. CDC
automated collection techniques or is the lead federal agency for this
ACTION: Notice of intent; announcement
other forms of information technology. Proposed Action.
of public meeting; and request for
Comments submitted in response to comments. DATES:
this notice will be summarized and Public Scoping Meeting: A public
included in the Agency’s subsequent SUMMARY: The Centers for Disease scoping meeting in open house format
request for OMB approval of the Control and Prevention (CDC) within will be held on June 26, 2018 in
proposed information collection. All the Department of Health and Human Slatyfork, West Virginia. The meeting
comments will become a matter of Services (HHS), in cooperation with the will begin at 5:30 p.m. and end no later
public record. General Services Administration (GSA), than 8:30 p.m.
announces its intent to prepare an Written comments: Written scoping
Francis D. Chesley, Jr., Environmental Impact Statement (EIS) comments must be submitted by 11:59
Acting Deputy Director. to analyze and assess the environmental p.m. on July 14, 2018.
[FR Doc. 2018–12767 Filed 6–13–18; 8:45 am] impacts of the proposed acquisition of Deadline for Requests for Special
BILLING CODE 4160–90–P
a site in Mace, West Virginia, and the Accommodations: Persons wishing to
development of this site into a participate in the public scoping
replacement of the National Institute for meeting who need special
daltland on DSKBBV9HB2PROD with NOTICES
Occupational Safety and Health accommodations should contact Sam
(NIOSH) Underground Safety Research Tarr at 770–488–8170 by 5:00 p.m.
Program facility (Proposed Action). The Eastern Time, June 19, 2018.
current acquisition and development ADDRESSES: The public scoping meeting
would replace the former Lake Lynn will be held at the Linwood Community
Experimental Mine in Fayette County, Library, 72 Snowshoe Drive, Slatyfork,
Pennsylvania and would support West Virginia 26291.
VerDate Sep<11>2014 16:38 Jun 13, 2018 Jkt 244001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\14JNN1.SGM 14JNN1](https://thefederalregister.org/doc/83_FR_27893/page/4.svg)
Document Created: 2018-06-14 01:39:25
Document Modified: 2018-06-14 01:39:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by July 16, 2018. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 83 FR 27778 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR