ASC OMB Draft A_2-5-2018 (002)

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.¹ 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.²

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.³ 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.”⁴

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.⁵ This appeal for safety culture improvements directly relate 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”).⁶ 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 Budget (OMB). In this request, AHRQ seeks OMB approval to expand its Surveys on Patient Safety Culture™ (SOPS™) 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 2010.⁷ 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.⁸ Research suggests that transitioning eligible surgical procedures from inpatient to ASC settings may yield significant and sustained Medicare cost savings.⁹

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.¹⁰ 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.¹¹ 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) program¹²^,¹³

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.”¹⁴ 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.¹⁵

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 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.¹⁶. 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.¹⁷

AHRQ made the survey publicly available along with a Survey User’s Guide, the pilot study results,¹⁸ 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, through its contractor, Westat. 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.

The goal of this project is to create the ASC SOPS Database. This database will:

Present results from ASCs that voluntarily submit their data;
Present trend data for ASCs that have submitted their data more than once;
Provide data to ASCs to facilitate internal assessment and learning in the patient safety improvement process; and
Provide supplemental information to help ASCs identify their strengths and areas with potential for improvement in patient safety culture.

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 (see Attachment A). 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 (see Attachment B), 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 (see Attachment C).

4) Data Files Submission –POCs upload their data file(s), using ASC survey data file specifications (see Attachment E), 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.

This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ’s statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement.¹⁹

2. Purpose and Use of Information

With the approval and addition of the ASC SOPS Database, data from will be used to produce three types of products:

An ASC SOPS Database Report that will be made publicly available on the AHRQ Web site (see, for example, another project in the SOPS suite, the Hospital User Database Report);²⁰
Individual ASC Survey Feedback Reports that are customized for each ASC that submits data to the database; and
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.

ASCs 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.

3. Use of Improved Information Technology

All information collection for the ASC SOPS Database is done electronically, except the Data Use Agreement (DUA), which ASCs will print, sign, and return (either via fax, by scanning and emailing or uploading to a secure Web site, or by mailing back). Registration, submission of ASC information, and data upload is handled online through a secure web site. Customized ASC survey feedback reports will be delivered electronically (the person submitting the data will enter a username and password and will have access to a secure Web site from which to download their reports).

4. Efforts to Identify Duplication

While survey vendors that administer the AHRQ ASC SOPS may maintain a small database of survey responses, AHRQ is the only entity that will serve as a central U.S. repository for data on the ASC SOPS survey and AHRQ will house the largest database of the survey’s results.

5. Involvement of Small Entities

AHRQ designed the data collection instruments and procedures to minimize burden on individual ASC staff respondents. The data requested of ASCs represents the absolute minimum information required for the intended uses and the data submission process does not unduly burden small ASCs or other businesses.

6. Consequences if Information Collected Less Frequently

Based upon AHRQ’s experience with its suite of other voluntary SOPS survey databases, most ASCs will submit data once every two years. Greater frequency may not be immediately feasible or desirable, given the time required to implement any new improvement interventions. ASC data submission is expected to occur every two years.

7. Special Circumstances

This request is consistent with the general information collection guidelines of 5 CFR 1320.5(d)(2). No special circumstances apply.

8. Federal Register Notice and Outside Consultations

8.a. Federal Register Notice

As required by 5 CFR 1320.8(d), notice was published in the Federal Register on March 14, 2018 on Page 11203 for 60 days (Attachment G). One comment was received.

8.b. Outside Consultations

AHRQ periodically convenes an external Technical Expert Panel (TEP) to provide expertise and guidance to the development, functioning, and expansion of the SOPS Databases. The TEP is comprised of 18 individuals with expertise for each of the seven different settings: hospital, medical office, nursing home, community pharmacy, ambulatory surgery center, international, and U.S. Department of Defense (see Attachment F). With representation from ASC experts, the TEP will provide guidance as needed on the administration of the ASC SOPS database.

9. Payments/Gifts to Respondents

No payment or remuneration will be provided to ASCs for submitting data to the database.

10. Assurance of Confidentiality

Individuals and organizations are assured limitation on use of certain information under Section 944(c) of the Public Health Service Act, 42 USC 299c-3(c). That law requires that information collected for research conducted or supported by AHRQ that identifies individuals or establishments be used only for the purpose for which it was supplied.

Privacy of the Point- of-Contact for an ASC. The individual that submits data on behalf of an ASC (“ASC point-of-contact”) is asked to provide his/her name, phone number and email address during the data submission process to ensure that the ASC’s individual survey feedback report is delivered to that person. Such contact information is critical if any clarifications or corrections of the submitted data set are necessary. However, the name of the ASC point-of-contact and name of the ASC is kept private and will not be reported. Only aggregated, de-identified results are displayed in any reports.

Privacy of the Survey Data Submitted by an ASC. ASCs are assured of the privacy of their ASC SOPS survey data responses under the Data Use Agreement (DUA) (see Attachment C). All respondents must sign the DUA. Reviewed by HHS’s general counsel, the DUA states that all submitted data will be handled in a secure manner using necessary administrative, technical and physical safeguards to limit access to it and maintain its privacy. In addition, the DUA outlines that survey response data will be used for the purposes of the database, that only aggregated results will be reported, and that the ASC will not be identified by name.

11. Questions of a Sensitive Nature

There are no questions of a sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

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

Form Name	Number of Respondents/POCs	Number of responses per POC	Hours per response	Total burden 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

Form Name	Number of Respondents/POCs	Total burden hours	Average hourly wage rate*	Total cost 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).

13. Estimates of Annualized Respondent Capital and Maintenance Costs

Capital and maintenance costs include the purchase of equipment, computers or computer software or services, or storage facilities for records, as a result of complying with this data collection. There are no direct costs to respondents other than their time to participate in the study.

14. Estimates of Annualized Cost to the Government

Exhibit 3 shows the estimated annualized cost to the government for developing, maintaining, and managing the database and analyzing the data and producing reports for each year in which data are collected. The cost is estimated to be $200,000 each data submission year.

Exhibit 3. Estimated Annualized Cost

Cost Component	Annualized Cost
Database Development and Maintenance	$75,000
Data Submission	$50,000
Data Analysis & Reports	$75,000
Total	$200,000

Exhibit 4: Estimated Annual cost to AHRQ for project oversight

AHRQ Position	% Time	Annualized Cost

GS-15, Step-5	3%	$3,896
GS-13, Step-5	3%	$4,582
Total		$8,478

https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2018/DCB.pdf

15. Changes in Hour Burden

This is a new collection of information.

16. Time Schedule, Publication and Analysis Plans

Information for the ASC SOPS Database will be collected by AHRQ through its contractor, Westat. ASCs will be asked to voluntarily submit their ASCs SOPS survey data to the database approximately every other year in the fall. The data will then be cleaned and aggregated to produce a Database Report that will be posted on the AHRQ web site. ASCs will also receive automatically their own customized survey feedback report.

17. Exemption for Display of Expiration Date

AHRQ does not seek this exemption.

List of Attachments:

Attachment A: Eligibility and Registration Form

Attachment B: Site Information (Site Level Data File Specifications)

Attachment C: Data Use Agreement

Attachment D: Data Submission Emails

Attachment E: Survey Data File Specifications

Attachment F: Databases TEP List

Attachment G: Federal Register Notice

1 Frequently Asked Questions: Surveys on Patient Safety Culture. Content last reviewed April 2015. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/pscfaq.html

2 See 42 C.F.R. §416.2. See https://www.gpo.gov/fdsys/granule/CFR-2010-title42-vol3/CFR-2010-title42-vol3-sec416-2. Last accessed 11/20/2017.

3 Healthcare Research and Quality Act of 1999. Available at https://www.ahrq.gov/policymakers/hrqa99a.html. Last accessed 11/20/2017.

4 See Section 902, (a) (8) of the Healthcare Research and Quality Act of 1999. Available at https://www.ahrq.gov/policymakers/hrqa99a.html. Last accessed 11/20/2017.

5 Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available at https://www.nap.edu/resource/9728/To-Err-is-Human-1999--report-brief.pdf. Last accessed 11/20/2017.

6 Internet Citation: Mission and Budget. Content last reviewed June 2017. Agency for Healthcare Research and Quality, Rockville, MD. Available at http://www.ahrq.gov/cpi/about/mission/index.html. Last accessed 11/20/2017.

7 MEDPAC. Report to the Congress: Medicare payment policy. Washington, DC. 2012, as cited in Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory surgery data from hospitals and ambulatory surgery centers: United States, 2010. National health statistics reports; no 102. Hyattsville, MD: National Center for Health Statistics. 2017. Available at https://www.cdc.gov/nchs/data/nhsr/nhsr102.pdf. Last accessed 11/20/2017.

8 Report to the Congress: Medicare Payment Policy. Medicare Payment Advisory Commission, March 2017, Executive Summary, pg. xiv-xv. See http://medpac.gov/docs/default-source/reports/mar17_entirereport.pdf. Last accessed 11/20/2017.

9 Koening L, Gu Q. Growth of ambulatory surgical centers, surgery volume, and savings to Medicare. Am J Gastroenterol. 2013 Jan; 108(1):10-5. doi: 10.1038/ajg.2012.183. Available at https://www.ncbi.nlm.nih.gov/pubmed/23287938. Last accessed 11/20/2017.

10 Ambulatory Surgical Center Healthcare-Associated Infection Initiative: Recovery Act-FY 2009 Plan Approvals. CMS website. See https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/ASC_HAI_MAP.pdf. Last accessed 11/20/2017.

11 “National Healthcare Safety Network Surgical Site Infection Surveillance.” Published on the Web site of the Association for Professionals in Infection Control and Epidemiology, 2013. Available at https://apic.org/Resource_/TinyMceFileManager/Academy/ASC_101_resources/Surveillance_NHSN/ASCA_NHSN_SSI_Surveillance_2013.pdf. Last accessed 11/20/2017.

12 See specifically: Section 3006(f) of the Patient Protection and Affordable Care Act (Pub. L. 111-148), enacted on March 23, 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152); as well as section 10301(a), which was enacted on March 30, 2010—Collectively known as the Affordable Care Act.

13 More information is available on the CMS ASC page (https://www.cms.gov/Center/Provider-Type/Ambulatory-Surgical-Centers-ASC-Center.html) and the CMS ASC Payment page (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/index.html).

14 Kulczycki M. “Ambulatory Buzz: New Patient Safety Systems Chapter for Ambulatory Care and Office-Based Surgery.” Joint Commission Blog. January 25, 2017. Available at https://www.jointcommission.org/ambulatory_buzz/new_patient_safety_systems_chapter_ambulatory_care_officebased_surgery/. Last accessed 11/20/2017.

15 “Medicare program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.” Centers for Medicare and Medicaid Services, final rule with comment period. 42 CFR Parts 414, 416, and 419. Federal Register, Vol. 82, No. 217, November 13, 2017, page 52356. Available at https://www.gpo.gov/fdsys/pkg/FR-2017-11-13/pdf/2017-23932.pdf.

16 Ambulatory Surgery Center Survey on Patient Safety Culture. Content last reviewed June 2017. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/sops/quality-patient-safety/patientsafetyculture/asc/index.html. Last accessed 2/5/2018.

17 MEDPAC. Report to the Congress: Medicare payment policy. Washington, DC. 2012, as cited in Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory surgery data from hospitals and ambulatory surgery centers: United States, 2010. National health statistics reports; no 102. Hyattsville, MD: National Center for Health Statistics. 2017. Available at https://www.cdc.gov/nchs/data/nhsr/nhsr102.pdf. Last accessed 11/20/2017.

18 MEDPAC. Report to the Congress: Medicare payment policy. Washington, DC. 2012, as cited in Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory surgery data from hospitals and ambulatory surgery centers: United States, 2010. National health statistics reports; no 102. Hyattsville, MD: National Center for Health Statistics. 2017. Available at https://www.cdc.gov/nchs/data/nhsr/nhsr102.pdf. Last accessed 11/20/2017.

tps://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patientsafetyculture/asc/resources/asc_pilotstudy.pdf. Last accessed 11/20/2017.

19 See 42 U.S.C. 299a(a)(1) and (2).

20 Hospital User Database Reports. Content last reviewed November 2017. Agency for Healthcare Research and Quality, Rockville, MD. Available at https://www.ahrq.gov/sops/quality-patient-safety/patientsafetyculture/hospital/hosp-reports.html. Last accessed 1/12/2018.

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ASC OMB Draft A_2-5-2018 (002)