Skip Navigation LinksReviewofRegulatoryStandards

licensing and certification

A Review of Regulatory Standards, Quality of Care Concerns, and Oversight of Ambulatory Surgery Clinics, Comprehensive Outpatient Rehabilitation Facilities, and  End-Stage Renal Disease Facilities

June 2017

 

 

Authors

Helen W. Wu, PhD Policy and Research Analyst, Institute for Population Health Improvement, UC Davis Health System

Emerald Montgomery, MPH Research Assistant, Institute for Population Health Improvement, UC Davis Health System

Kenneth W. Kizer, MD, MPH Distinguished Professor, UC Davis School of Medicine and Betty Irene Moore School of Nursing; Director, Institute for

Population Health Improvement, UC Davis Health System Principal Investigator, CDPH Contract #14-10348

 

Acknowledgments and Disclaimer

This work was supported by the California Department of Public Health, Center for Health Care Quality, Licensing and Certification Division, under contract #14-10348 ("SB 534 Evaluation") awarded to the Institute of Population Health Improvement, UC Davis Health System. The ideas and opinions expressed herein are those of the authors, and endorsement by the State of California, Department of Public Health, or their Contractors or Subcontractors is not intended, nor should it be inferred.

The authors are grateful for the contributions of several other persons who assisted in the development of this report: Alex Morath-Shap, Muree Larson-Bright, James Booth, Mallory Johnson, Brenda Klutz, Elizabeth LaBouyer, Yvonne Choong, Harriet Edwards, Eileen Boyte, Elizabeth Randall, and Christine Douglas.

 

Inquiries regarding the content of this report should be directed to:

Institute for Population Health Improvement 4800 2nd
Ave., Suite 2600 Sacramento, CA 95817 (916) 734-4754

http://www.ucdmc.ucdavis.edu/iphi/

 

UC%20Davis 


This publication was prepared by the Institute for Population Health Improvement, University of California Davis
4800 2nd Ave., Suite 2600
Sacramento, CA 95817
(916) 734-4754
http://www.ucdmc.ucdavis.edu/iphi/

Suggested citation:
Wu HW, Montgomery E, and Kizer KW. A Review of Regulatory Standards, Quality of Care Concerns, and Oversight of Ambulatory Surgery Clinics, Comprehensive Outpatient Rehabilitation Facilities, and End-Stage Renal Disease Facilities. Sacramento, CA: Institute for Population Health Improvement, University of California Davis, December 2015.

Copyright information:
All material in this report is in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated.

Prepared by:
Helen W. Wu, PhD
Policy and Research Analyst, Institute for Population Health Improvement,
UC Davis Health System

Emerald Montgomery, MPH
Research Assistant, Institute for Population Health Improvement,
UC Davis Health System

Kenneth W. Kizer, MD, MPH
Distinguished Professor, UC Davis School of Medicine and Betty Irene Moore School of Nursing;
Director, Institute for Population Health Improvement, UC Davis
Principal Investigator, CDPH Contract #14-10348

 

 

​​Table of Contents

​Summary
​Acronyms
I. Background
Results

​III. Accreditation Standards

Methods

Results

​IV. Quality Concerns in ASCs, CORFs, and ESRD Facilities

Methods

Results

Quality Issues from the Literature

Table 1. Literature Review Search Results

Compliance Violations in California: L&C Survey Findings

Data Limitations

Conclusion

​V. Study Conclusions
​Appendix A - State Licensing Laws
​Appendix B - Quality Issues from the Literature

​Appendix C - Quality Issues in California: L&C Survey Findings

Figure C1. Compliance Violations in California ASCs

Figure C2. Compliance Violations in California CORFs

Figure C3. Compliance Violations in California ESRD Facilities

 

Summary

This study was conducted at the request of the California Department of Public Health (CDPH), which was directed by Section 1225(e) of the California Health & Safety Code (as amended by California Senate Bill 534, statutes of 2013-2014) to submit a report that “describes the extent to which federal certification standards are or are not sufficient as a basis for state licensing standards,” and if not, what California-specific standards may be necessary. Section 1225(e) specifically focuses on this question with regard to ambulatory surgery clinic (ASC), comprehensive outpatient rehabilitation facility (CORF), and end-stage renal disease (ESRD) facilities. Currently, CDPH uses federal Centers for Medicare and Medicaid Services (CMS) certification standards as the sole basis for state licensing of these facilities.

To inform CDPH about this issue, the Institute for Population Health Improvement (IPHI) at the University of California Davis was asked to address two primary questions: 1) what regulations are other states using to oversee these facilities, and 2) what are the known quality issues – defined broadly as concerns related to safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity? Taken together, the answers to these questions provide dual perspectives on whether California’s use of the federal standards constitutes adequate oversight, and whether additional standards may be advised to fill in gaps. We undertook comprehensive, systematic reviews to identify information to answer these questions, and our findings are detailed in this report.

We identified a diverse assortment of regulatory language in other states which differed from federal certification standards. By and large, however, these differences were primarily semantic or of relatively minor consequence. The most substantive differences across state regulations pertained to the conditions under which accreditation was required, definitions of facility types, and the scope of regulations that followed from those definitions. State-specific provisions covered topics ranging from the use of flammable anesthetics to minimum staffing levels. No single, quality-related topic was repeatedly addressed in other states. Quality concerns identified in other states and in the literature frequently cited compliance problems with existing regulations instead of calling for expanded regulations. Deficiencies found through CDPH compliance surveys are consistent with this observation.

In summary, we conclude that:

  • California’s use of CMS certification standards as the basis for state licensure is consistent with standard practice across the nation;
  • California differs from some other states in not requiring accreditation for some ASCs (i.e., California requires accreditation only for those that provide higher levels of sedation) or for CORFs, and in the requirements for specific types of facilities and services, such as for adverse event reporting;
  • Better compliance with existing federal regulations would likely address many of the documented quality problems that CDPH has cited in these facilities; and
  • Based on information reviewed, expanded state-specific regulations for ASC, CORF, and ESRD facilities would be of uncertain marginal value.
  • Future consideration of the need for expanded regulatory oversight of ASC, CORF and ESRD facilities should be based on a more detailed, evidence-based understanding of quality problems in these facilities and how regulations would specifically address the root causes of such problems.

 Return to table of contents

 

 

Acronyms

 

AAAASF​​American Association for Accreditation of Ambulatory Surgery Facilities AAAHC Accreditation Association for Ambulatory Health Care
​​ASC Ambulatory surgery clinic
​​CARF Commission on Accreditation of Rehabilitation Facilities
​CDPH​ California Department of Public Health
​CFR​Code of Federal Regulations
​CMS​Centers for Medicare and Medicaid Services
​CORF​Comprehensive outpatient rehabilitation facility
​ESRD​End-stage renal disease
​GAO​Government Accountability Organization
​HFAP​Healthcare Facilities Accreditation Program
​IPHIInstitute for Population Health Improvement ​
​L&C​Licensing & Certification Program
OIGOffice of Inspector General​

 

  Return to table of contents

 

 

Regulatory oversight of health care delivered in ambulatory settings is generally less rigorous than for inpatient settings because of the typically lower risk of outpatient care. Nonetheless, serious quality of care problems may occur in ambulatory settings. Relatively little is known about such problems.

The California Department of Public Health (CDPH) is the state agency in California responsible for health facility licensing and certification, including for ambulatory surgery clinics (ASC, also known as ‘surgical clinics’), comprehensive outpatient rehabilitation facilities (CORF, also known as ‘rehabilitation clinics’), and end-stage renal disease (ESRD) facilities (also known as ‘dialysis clinics’). CDPH licenses these facilities using standards established by the Centers for Medicare and Medicaid Services (CMS) for federal Medicare certification purposes [Conditions
for Coverage and Conditions for Participation, as documented in Title 42 of the Code of Federal Regulations (CFR)], and it also performs federal certification.1

Currently, CDPH uses the CMS certification standards as the sole basis for state licensing of ASC, CORF, and ESRD facilities, with no additional state standards. In other settings, however, CDPH licensing standards are more expansive than federal certification regulations. Given the volume of ambulatory care that Californians receive and concerns about potential quality issues, the California Senate Health Committee called for CDPH to report on whether the federal certification standards used for licensing ASC, CORF, and ESRD facilities are adequate.
Section 1225(e), Health & Safety Code (as amended by Senate Bill 534, statutes of 2013-2014) calls for a report that: 1) describes the extent to which the federal certification standards are or are not sufficient as a basis for state licensing standards, and 2) make recommendations for any California-specific standards that may be necessary.2 The CDPH Center for Health Care Quality, Licensing & Certification Program (L&C), contracted with the Institute for Population Health

Improvement (IPHI) at the University of California Davis to conduct a study and write a report. This report addresses the Section 1225(e) requirements by answering three study questions: 

  1. Current regulations. What standards and regulations are currently in place to regulate quality of care for ASC, CORF, and ESRD facilities
  2. Quality issues. What quality problems have been documented in these care settings?
  3. Regulatory opportunities. Given the current regulations and quality concerns regarding ASC, CORF, and ESRD facilities, should any additional, California-specific standards be considered?

This report addresses these questions; detailed appendices are provided for reference.

  • Chapter II, Licensing Standards: 50 State Review, describes the standards used in all states and compares them to California standards and federal regulations.
  • Chapter III, Accreditation Standards, discusses accreditation standards that may be used for state licensure and/or certification, highlighting differences with the federal regulations.
  • Chapter IV, Quality Issues in ASC, CORF, and ESRD Facilities, outlines quality concerns identified through a systematic literature review which examined quality based on the six domains of safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity. It also provides a snapshot of the quality issues that have been documented in California facilities via L&C surveys for the past 10 years.
  • Chapter V, Conclusions, outlines our conclusions to the three study questions, based on findings described in Chapters II-IV.

This report focuses primarily on issues that are under CDPH’s licensing and certification oversight authority. Notably, some outpatient healthcare settings fall outside of CDPH oversight, including physician-owned ASCs, which are the responsibility of the Medical Board of California. In these cases, patients receiving the same outpatient procedures may be doing so in facilities that have materially different regulatory oversight requirements. Another recent report describes the regulatory patchwork that characterizes ambulatory surgical procedures in
particular.3 Although such regulatory inconsistencies may be cause for concern, they are beyond
the scope of this study.

____________________________________________

1 U.S. Office of the Federal Register, National Archives and Records Administration. (2015). Electronic Code of Federal Regulations, Title 42 - Public Health.
2 Section 1225(e), California Health & Safety Code amended subsequent to Senate Bill No. 534 (statutes of 2013- 2014). Retrieved fromthe Legislative Information database at http://www.leginfo.gov 
3 B & R Klutz Consulting. (2015). Outpatient surgery services in California: Oversight, transparency, and quality.
Retrieved from http://www.chcf.org/publications/2015/07/limited-visibility-outpatient-surgery

  Return to table of contents

 

 

II. Licensing Standards: 50 State Review

 

Healthcare facilities must meet federal certification requirements to participate in and receive payment from Medicare. The federal standards establish a uniform, national regulatory framework, and state agencies survey facilities for compliance with certification requirements on behalf of CMS. States may also use the federal standards as the basis for state licensing, although states may have different standards for licensure. This chapter outlines the state-specific regulatory requirements for licensing which extend beyond federal certification requirements. It identifies licensing regulations in all 50 states, including a discussion of states’ regulatory and rulemaking authority, facility definitions, and state licensure requirements in comparison to California.

 Return to table of contents

 

Methods

To identify the licensing standards pertaining to ASC, CORF, and ESRD facilities in all 50 states, we used a multi-faceted search strategy and consulted with a reference librarian to validate our strategy. Although some law and policy-focused databases are available to facilitate the search for regulations (e.g., Lexis-Nexis), the reference librarian cautioned us that such sources may be outdated, inconsistent across states, or inaccurate given the complexity of information governing health facilities regulations.


Accordingly, we drew primarily from internet-based information found on state health department and legislative websites to capture the most complete and up-to-date information. We initially reviewed the state health department’s website and followed it to related sites, such as the state’s general website or legislative database, in order to find where the state’s licensing standards for ASC, CORF, and ESRD facilities were memorialized. We conducted this search between November 2014 and February 2015, and updated it in August 2015.


We used several other sources to validate search results against the reviews of state licensing regulations for ASC, CORF, and ESRD facilities. We reviewed an online legal research service (Westlaw) and general health law/policy sources (e.g., National Conference of State Legislatures policy database). We conducted targeted review and selective outreach to industry associations
representing ASC, CORF, and ESRD facilities. We also drew upon work by the Accreditation Association for Ambulatory Health Care (AAAHC)4 to fill in gaps, when information from state websites was lacking for ASCs.


For each state, we summarized information that described the: 1) regulatory agency overseeing licensing and/or certification, 2) rulemaking authority defined in state law or administrative rules, 3) facility definitions, focusing on differences between CMS and state definitions, 4) state licensure requirements (yes or no, indicating “no” for states for which we could not find anyinformation about licensure requirements), 5) additional state licensure requirements which were not addressed in a section of the CMS standards, and 6) additional detail contained in state standards for licensure which expanded upon language in the CFR (i.e., potentially establishing stricter state compliance requirements due to greater specificity). For the additional state standards in item six, we reviewed the CMS requirements to determine whether there were meaningful differences, erring on the side of inclusion, and we compared these additional standards to the relevant CFR section. When the CMS rules generally referred to state standards (e.g., requiring compliance with the respective state’s occupational health and safety codes), we did not mark this as a “different” or new standard. Tables A1-A3 (Appendix A) detail this information for ASC, CORF, and ESRD facilities, respectively.

Definitions of ASC, CORF, and ESRD facilities vary across states. A common distinction was whether facilities were licensed as part of a general acute care hospital, or facilities that provide inpatient care lasting more than 24 hours. To be consistent with California’s licensing requirements, which include these services under hospital-based licensing rules, we excluded these from the search in order to align our review with California’s definition of ASC, CORF, and ESRD facilities to the extent possible. In anticipation of variation in facility definition, we used the following keywords to identify on state websites the health facility types of interest:

Ambulatory Surgery Clinic

  • ambulatory surgery center, ambulatory surgical center, ambulatory surgical facility, ambulatory surgical treatment center, day surgery center, freestanding ambulatory surgical center, freestanding surgical clinic, freestanding surgical outpatient facility, health clinic, outpatient hospital, outpatient surgery center, outpatient surgical center, outpatient surgery facility, surgical clinic, surgicenter

Comprehensive Outpatient Rehabilitation Facility

  • ambulatory care facility, health facility, general outpatient treatment center, non- residential facility, outpatient facility, outpatient physical therapy center, rehabilitation center, rehabilitation clinic

End-Stage Renal Disease Facility

  • ambulatory dialysis, dialysis clinic, freestanding dialysis center, dialysis facility, free- standing dialysis facility for renal disease, free-standing specialty clinic, health clinic, hemodialysis, kidney center, kidney dialysis center, kidney dialysis unit, out-of-hospital dialysis unit, out-of-hospital out-patient dialysis unit, outpatient facility

We vetted our initial findings from this review with L&C staff, producing an interim report in July 2015. This report supersedes the interim report. Findings were updated following further review and analysis of the additional state standards that we identified in the interim report; some of the differences that we initially identified were primarily semantic and did not effectively introduce any new regulations that extended beyond federal certification rules.

________________________________________

4 Accreditation Association for Ambulatory Health Care. (2015). Retrieved fromhttp://www.aaahc.org/

 Return to table of contents

 


Results

Ambulatory Surgery Clinics

Federal certification standards for ASCs are outlined in 42 CFR Part 416 and described further in CMS’ State Operations Manual, Appendix L.5 They address 12 general areas, each with specific standards or requirements:

  • Governing body and management
  • Surgical services
  • Quality assessment and performance improvement
  • Environment
  • Medical staff
  • Nursing services
  • Medical records
  • Pharmaceutical services
  • Laboratory and radiologic services
  • Patient rights
  • Infection control
  • Patient admission, assessment and discharge

Table A1 (Appendix A) details the regulatory and rulemaking authority, facility definition, state licensure requirements, and additional state licensure standards beyond the federal ones for ASCs. A synopsis of the differences between California and other states for each of these subtopics follows.

Regulatory and rulemaking authority. The agency responsible for enforcing health facility licensing regulations and conducting surveys and inspections in most states is the department of health (or public health). Exceptions are Washington, DC, where the mayor’s office has this role; the Agency for Health Care Administration in Florida; and the Health Authority in Oregon. As in California, some other states direct oversight for physician-owned ASCs to medical professional bodies. The New Jersey Board of Medical Examiners regulates private physician practices that have only one operating room. All but Idaho, Iowa, and Wisconsin have statutes in their respective administrative codes and legislative documents that describe minimum standards that must be met, as well as general rules for health facilities; we were unable to find such information for these three states.

Definition and exclusions. CMS defines ASCs as, “any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission.”6 California defines an ASC as one that is not part of a hospital and provides care for patients who stay less than 24 hours.” California’s specification of ASCs as being separate from hospitals, in contrast to whether the service may require hospitalization, is a notable distinction from the federal definition.

Other states’ definitions of ASCs vary considerably. Most, but not all, specify that services should be outpatient, not requiring hospitalization, or provide care for less than 24 hours. Many states also note that ASCs should be freestanding facilities that are not part of a hospital facility, as with California, although a notable number do not include this requirement. Some states define specific services that are included (e.g., abortions, endoscopic procedures, pain management) or excluded in the ASC definition, although California does not. Not included as ASCs in many states are independent medical doctor, podiatrist, and dentist offices; facilities belonging to a licensed hospital; and federally owned institutions.

Additional state licensure requirements not addressed in federal standards. All states except Idaho, Vermont, and Wisconsin require state licensure, although we could not find information about whether Iowa required licensure. New Jersey requires licensure only for facilities with more than one operating room. Pennsylvania allows Class A ASCs (those which are limited to local and topical anesthesia) to be accredited but not licensed. In California, surgical clinics that are owned wholly or in part by physicians are regulated solely by the Medical Board of California. As a condition of licensure, two states (Maryland and Michigan) specifically cited federal CMS certification as a requirement. Seven states also noted that accreditation is required, with some of those states (including California) requiring accreditation only when higher levels of anesthesia (i.e., more than local and topical anesthesia) are provided.

States largely refer to CMS requirements, but 32 of the 46 states requiring licensure have additional language in their licensure provisions which address topics not covered under the CMS standards. Many of these detail specific operational requirements and restrictions.
Directives for facility accreditation are also commonly found in state administrative codes. California, for instance, requires accreditation for certain unlicensed ASCs (i.e., physician- owned) when higher levels of anesthesia are provided. Examples of state-specific licensure requirements that are not linked to a section of the CMS standards are:

  • Accreditation. Accreditation is encouraged or required, depending on various conditions such as the level of anesthesia provided (multiple states).
  • Clinical. The use of flammable anesthetics is prohibited (Colorado, New Mexico); facilities must establish a protocol for organ donation (Virginia); a short stay record form must be used (Indiana); must have a current agreement with a blood bank (Massachusetts); examination and treatment rooms must meet minimum standards and an emergency communication connection with the surgical control station is required (New Mexico); drug administration and blood transfusion must comply with state law (North Dakota).
  • Operations. Proof of compliance with the state fire code is needed (New Hampshire); environmental pollution control considerations must be in place (Oklahoma); smoking is not permitted (Rhode Island); no smoking signs must be posted (Tennessee); electrical work complies with state laws (Georgia); zoning requirements apply (Maine); specific signage must be visible if abortions are performed in the facility (Ohio); license is issued for specified bed size/rooms (Rhode Island, Florida); live animals are not permitted (South Carolina); extended recovery care services are not permitted for more than four patients between 10 pm and 6 am (Wyoming).
  • Food services. A food safety system must be in place (Alabama); the food and nutrition services supervisor must be a certified dietary manager (Arkansas); a consulting dietician shall oversee special dietary needs (Hawaii); food served must be approved by the health licensing division (South Carolina); a food service establishment permit is required (Utah); nutritional services must be provided (Delaware).
  • Employee policies. Those affiliated with the clinic must be vaccinated against influenza (Massachusetts); employees in patient care areas must wear identification badges (Maine); every position shall have a written description of job duties (Mississippi); pre- employment criminal background and registry checks are required on unlicensed staff (Nebraska); annual in-service training for nurses is needed (Oregon).
  • Staffing. Must provide at least one physician licensed to practice in the state (Virginia).

Additional state detail for existing federal standards. Seven states have expanded upon existing CMS Conditions for Coverage. Generally, these differences address staffing and documentation issues. The additional state licensure standards for ASCs, organized by relevant section of the CFR, are:

§416.41. Governing body and management

  • Alabama - A copy of the governing body meeting minutes must be kept as a permanent record of the facility.
  • Delaware - A governing body with full-time director must be in place.
  • Florida - A detailed emergency management plan is outlined in the administrative code.

§416.45. Medical staff

  • New Jersey - The facility shall establish and implement written policies and procedures concerning the identification of the need for counseling services and referral to counseling services.

§416.46. Nursing services

  • Alabama - The Director of Nursing must be a licensed graduate of a professional nursing school with one or more years of experience in surgical/recovery nursing.

§416.50. Patient rights

  • Florida - A facility must notify each patient during admission and at discharge of his or her right to receive an itemized bill upon request.

§416.52. Patient admission, assessment and discharge

  • Arkansas - The extended stay area must be staffed by at least two caregivers, one of whom must be a registered nurse.
  • North Carolina - A post-anesthesia note containing the general condition of the patient and any instructions to the patient must be written prior to discharge.
  • Utah - The physician must document the reason for admission to an extended recovery service and dietary orders.

____________________________________________

5 CMS Survey and Certification - Guidance to Laws & Regulations, Ambulatory Surgery Centers. (2012). Retrieved from www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/ASCs.html 

6 Public Health. 42 CFR §416.2 (2015).

  Return to table of contents

 

Comprehensive Outpatient Rehabilitation Facilities

Federal certification standards for CORFs are outlined in 42 CFR and described further in CMS’ State Operations Manual, Appendix K.7 CMS certification standards address six general areas:

  • Governing body and administration
  • Comprehensive rehabilitation program
  • Clinical records
  • Physical environment
  • Disaster procedures
  • Utilization review plan

Table A2 (Appendix A) details the regulatory and rulemaking authority, facility definition, state licensure requirements, and additional state licensure standards beyond the federal ones for CORFs. The primary differences between California and other states for each of these six areas are noted below.

Regulatory and rulemaking authority. The regulatory agency overseeing CORF licensing is similar to that of ASCs, although we could not find policies or regulations outlining CORF regulations for 40 states and the District of Columbia. In contrast to ASCs, the Medical Board has no responsibility for overseeing CORFs in California.

All states but Idaho, Iowa, and Wisconsin describe minimum standards that must be met, as well as general rules for health facilities; we were unable to find such information for these three states.

Definition and exclusions. CMS defines a CORF as a “nonresidential facility established and operated for the purpose of providing therapeutic and restorative services to outpatients for the rehabilitation of injured, disabled, or sick persons at a single fixed location and by a physician/under physician supervision.”8 California defines a CORF as “a clinic that, in addition to providing medical services directly, also provides physical rehabilitation services for patients
who remain less than 24 hours.” It additionally specifies that at least two of the following rehabilitation services must be provided: physical therapy; occupational therapy; or social, speech pathology, and audiology services. It also notes that a CORF excludes the offices of a private physician in individual or group practice. California’s definition is more specific than the federal one in the services included, and it excludes private physician offices. In other states, a CORF typically does not include certified home health agencies or the offices of a private physician in individual or group practice.

Most states do not specifically define a CORF, and when they do, it closely mirrors the CMS definition. Ten states offer additional details about exclusions and services provided. In the definitions for Alabama, California, Georgia, Kentucky, Ohio, and Washington, physical therapy, occupational therapy, and speech pathology are specified as services provided; in Georgia and Ohio these services may be provided off-site. Wyoming also includes therapy for persons with brain injury in its definition. Mississippi, New Jersey, and Pennsylvania further stipulate that social or psychological services must be provided in a coordinated manner.

Additional state licensure requirements not addressed in federal standards. The majority of states either do not require licensing of CORFs or their websites do not contain information on state-specific CORF regulations. We found such information in only seven states (Alabama, Arizona, California, Kentucky, Maryland, New Jersey, and Wyoming).

Three states specify that CMS certification is required (Louisiana, Missouri, and Oklahoma); CORFs in New Jersey are required to be certified or eligible for certification. Two states require accreditation (Maryland and Wyoming), although in Texas CORFs are not eligible for accreditation. Examples of state-specific licensure requirements that are not linked to a section of the CMS standards are:

  • Accreditation. Accreditation by the Commission on Accreditation of Rehabilitation Facilities is required (Maryland); rehabilitation facilities providing services to adults with developmental disabilities must maintain accreditation (Wyoming).
  • Operations. Requirements for communication systems and narcotic permits are outlined in the administrative code (Alabama); must keep records and make reports in accordance with Secretary requirements (Maryland); general construction rules for healthcare facilities apply (Montana, Nebraska, Utah).

Additional state detail for existing federal standards. Only two states (Alabama and Maryland) add to language in the CMS standards. Alabama’s administrative code expands considerably on CMS standards, particularly regarding standards for the physical environment. It requires designated space for an admission office, a waiting room, and a janitorial closet, as well as written procedures detailing housekeeping and decontamination techniques. It also requires an emergency call system. Maryland mandates licensees to follow recordkeeping instructions prescribed by its Secretary of Health. The additional state licensure standards for CORFs, organized by relevant section of the CFR, are:

§ 485.60. Clinical records

  • Maryland - Licensees must keep records and make reports in the manner and form as the Secretary shall prescribe and be open to inspection by the Secretary.

§ 485.62. Physical environment

  • Alabama - Extensive guidelines for the provision of an admissions office, waiting room, and housekeeping, set forth in the state administrative code.

§ 485.64. Disaster procedures

  • Alabama - There shall be an adequate number of telephones to summon help in case of fire or other emergency, and these shall be located so as to be quickly accessible from all parts of the building.

________________________________________

7 CMS Survey and Certification - Guidance to Laws & Regulations, Comprehensive Outpatient Rehabilitation Facilities.Retrieved fromhttp://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/GuidanceforLawsAndRegulations/CORF.html

8 Public Health. 42 CFR §485.51 (2015). 

  Return to table of contents

 

End-Stage Renal Disease Facilities

Federal certification standards for ESRD facilities are outlined in 42 CFR Part 494 and described further by the CMS Conditions of Participation.9 The CMS standards cover 15 general areas, each with specific standards or requirements:

  • Infection control
  • Water and dialysate quality
  • Reuse of hemodialyzers and bloodlines
  • Physical environment
  • Patients' rights
  • Patient assessment
  • Patient plan of care
  • Care at home
  • Quality assessment and performance improvement
  • Special purpose renal dialysis facilities
  • Laboratory services
  • Personnel qualifications
  • Responsibilities of the medical director
  • Medical records
  • Governance

Table A3 (Appendix A) details the regulatory and rulemaking authority, facility definitions and exclusions, state licensure requirements, and additional state licensure standards beyond the federal ones for ESRD facilities. The primary differences between California and other states for each of these 15 areas are noted below.

Regulatory and rulemaking authority. The agencies that enforce state regulations for ESRD facilities are the same as those for CORFs and ASCs. California law does not raise issues of physician ownership or Medical Board oversight for ESRD facilities, as it does with ASCs.
Additional regulatory information regarding ESRD facilities is sparse.

Definition and exclusions. CMS defines an ESRD facility as “an entity that provides outpatient maintenance dialysis services, or home dialysis training and support services, or both. A dialysis facility may be an independent or hospital-based unit that includes a self-care dialysis unit that furnishes only self-dialysis services.”10 California defines an ESRD facility as “a free-standing specialty clinic, which provides less than 24-hour care for the treatment of patients with ESRD.” The free-standing component of California’s definition makes it more restrictive than the federal definition, which includes hospital-based dialysis.

While ESRD facilities are generally referred to as non-hospital-based facilities, outpatient renal dialysis facilities may be hospital-based clinics in Colorado, Iowa, Kentucky, Ohio, and Vermont.

Additional state licensure requirements not addressed in federal standards. The District of Columbia and 25 states (including California) have statutory licensing requirements for ESRD facilities. Licensing is not required in Oklahoma, but CMS certification is. We were unable to find information on licensing or certification for ESRD facilities in Alaska, Iowa, Michigan, Mississippi, Montana, New York, and North Dakota.

State licensure of ESRD facilities usually follows federal standards with no additional requirements. Two states and the District of Columbia specify additional licensing conditions; New Jersey is the only one with extensive additional requirements. State-specific licensure requirements not linked to a section of the CMS standards are:

  • Colorado - Outpatient hemodialysis treatment of a non-ESRD patient is not permitted without referral for treatment from a board-certified or board-eligible nephrologist licensed in the state.
  • District of Columbia - State standards and procedures cannot be less stringent than the guidelines in the Association for Advancement of Medical Instrumentation Recommended Practice or Centers for Disease Control and Prevention recommendations.
  • New Jersey - Facilities must have transfer agreements with at least one CMS-certified hospital to provide inpatient dialysis and with one state-licensed renal transplantation program. Policies related to criteria for handling of aggressive patients and orientation of new patients are required. Patients are prohibited from bringing food into the facility.

Additional state detail for existing federal standards. Three states and the District of Columbia expand upon the CMS regulations. ESRD facilities have long been subject to substantial federal oversight; additional state regulation has been limited. State expansion of the CMS standards include:

§494.30. Infection control

  • Massachusetts - The unit shall obtain blood from a blood bank immediately prior to its administration. All blood so obtained shall be identified, stored, handled and administered in accordance with 105 CMR 135.000: Use of Blood, Blood Components and Derivatives for the Purpose of Transfusion.
  • Utah - Facilities must establish a written health surveillance and evaluation program for facility personnel (according to the Communicable Disease Rule, R386-702; Tuberculosis Control Rule, R388-804; and OSHA guidelines for blood-borne pathogens) that includes a health status exam.

§494.50. Reuse of hemodialyzers and bloodlines

  • District of Columbia - Reuse of tubing or transducer protectors and reuse of hemodialyzer or dialyzer caps without express written consent of the patient are not permitted.

§494.60. Physical environment

  • Massachusetts - A minimum of 110 square feet of floor space per station is required.
  • New Jersey - Facilities must provide at least six dialysis stations and an emergency generator and water supply.

_______________________________________________
9 CMS Survey and Certification - Guidance to Laws & Regulations, Dialysis. Retrieved from http://www.cms.gov/ Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Dialysis.html

10 Public Health. 42 CFR §494.10 (2015).

  Return to table of contents

 

Data Limitations

State government websites and administrative codes may not always be kept current, may not completely capture all information about licensing requirements, or may not make all pertinent information readily available. During our review we found multiple sources of regulatory information within state websites, raising the possibility that the sources used for this report may not have been absolutely current and complete. Sometimes there was insufficient detail on policies and procedures to allow for definitive determination of requirements listed on state websites, particularly with regard to CORFs and ESRD facilities.

Adverse event reporting requirements were not typically described as part of the regulatory language pertaining to general licensure requirements, so we did not report on this, although some states require all licensed healthcare facilities to report on adverse events. Other state-based requirements documented separate from general healthcare licensure provisions, might have been missed in this review. A survey of state agencies responsible for overseeing ASC, CORF, and ESRD facilities would be helpful to validate the completeness and currency of our information, but this was beyond the scope of our work.

  Return to table of contents

 

Conclusions

Overall, we did not find significant state licensing requirements addressing clinical quality or safety additional to CMS certification standards for ASC, CORF, and ESRD facilities. ASC and ESRD facilities were subject to additional licensing requirements in some states, though these primarily addressed facility operational matters. A few states addressed clinical practice issues in ASCs. Additional state ESRD facility standards were more clinically focused, though New Jersey was the only state that included a substantive set of state regulatory requirements for these facilities. We identified almost no additional state standards for CORFs. Variations in state administrative procedures, implementation guidance, or unpublished updates may introduce differences that were not readily apparent through the information we reviewed.

 Return to table of contents

 

III. Accreditation Standards

 

 Return to table of contents 

 

 

  Return to table of contents

Results

 

Ambulatory Surgery Clinics

Seven states require ASCs to obtain accreditation as a condition of state licensure: Delaware, Georgia, Nevada, North Carolina, Pennsylvania, and Rhode Island. Accreditation is required in California for physician-owned ASCs that use general anesthesia. There are four accreditation organizations with deemed status from CMS for ASCs.

American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF). AAAASF is one of the nation’s largest accrediting organizations, accrediting more than 2,000 facilities nationwide. The AAAASF Medicare ASC Standards and Checklist11 addresses:

  • Basic mandates
  • Operating room policy, environment, and procedures
  • Recovery room environment, policy, and procedures
  • General safety in the facility
  • Intravenous fluids and medications
  • Medical records
  • Quality assessment / quality improvement
  • Personnel
  • Governance
  • Anesthesia

The AAAASF standards contain the same general elements of the CMS requirements, but we found some examples where the accreditation standards were more detailed. For example, the AAAASF standard stipulates a minimum height and width for hallways, ramp requirements, and door opening sizes; the CMS standards do not include such specifications.

Accreditation Association for Ambulatory Health Care (AAAHC). AAAHC accredits a broader set of facilities than the AAAASF, including ASCs, community health centers, medical and dental group practices, medical homes, and managed care organizations. It is currently the predominant accreditation body for ASCs in California. It can grant ASCs deemed status. The seven core areas covered by its ASC accreditation standards are:

  • Rights of patients
  • Governance
  • Administration
  • Quality of care provided
  • Quality management and improvement
  • Clinical records and health information
  • Infection prevention and control and safety
  • Facilities and environment

The AAAHC standards12 are mostly identical to the CMS standards. Some AAAHC standards have more detailed or stringent requirements.13 For example, the AAAHC requires emergency preparedness drills at least quarterly, compared to a minimum yearly requirement by CMS.

The Joint Commission. The Joint Commission has CMS recognition to provide deemed status and is the largest accrediting body for healthcare organizations overall, covering a range of ambulatory care settings (including ASCs and office-based surgery, imaging, urgent care), hospitals, laboratories, behavioral health facilities, home care, nursing facilities, and more. Hospitals that are accredited by The Joint Commission could have their outpatient surgical services covered under the hospital accreditation standards; here, we focus on standards that apply for accreditation as an ambulatory care facility. The Joint Commission ambulatory care standards address 14 general areas, including sentinel events which are applicable in multiple accreditation standards:14,15

  • Environment of care
  • Emergency management
  • Human resources
  • Infection prevention and control
  • Information management
  • Leadership
  • Life safety
  • Medication management
  • National Patient Safety Goals
  • Provision of care, treatment, and services
  • Performance improvement
  • Record of care, treatment, and services
  • Rights and responsibilities of the individual
  • Sentinel events
  • Transplant safety
  • Waived testing

We also found examples of some noteworthy differences between The Joint Commission and CMS standards. Whereas the CMS standards for peri-operative anesthesia monitoring refer generally to current clinical guidelines, the Joint Commission language requires ongoing monitoring for higher risk procedures or those with moderate to deep sedation or anesthesia, including continuous monitoring of the patient’s oxygenation, ventilation, and circulation.
Moreover, The Joint Commission standards address broader topics that are not covered in the CMS standards, including a specific set of National Patient Safety Goals, as well as detailed procedures for medication management.

American Osteopathic Association, Healthcare Facilities Accreditation Program (HFAP). Originally created to review services provided by osteopathic hospitals, HFAP also has deeming authority to accredit ASCs. Detailed information about the HFAP standards was not available.16

_______________________________________

11 American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (2014). Medicare Standards and Checklist for Accreditation of Ambulatory Surgery Facilities. Retrieved from http://www.aaaasf.org/Surveyor/cms_web/PDF/FILES/ASC/PDFS/ASC/Standards.pdf

12 Accreditation Association for Ambulatory Health Care. (2015). Accreditation Handbook for Office-Based Surgery Including Review Guidelines.

13 Accreditation Association for Ambulatory Health Care. (2012). 2012 AAAHC/CMS Crosswalk. Retrieved from https://www.aaahc.org/Global/2012/AAAHC-CMS/Crosswalks/7-16-12.pdf

14 The Joint Commission. (2015). Comprehensive Accreditation Manual for Ambulatory Care. Retrieved from https://www.jcrinc.com/assets/1/14/CAC15_Sample_Pages.pdf

15 Joint Commission. (2010). Standards Sampler for Ambulatory Surgery Centers. Retrieved from
http://www.jointcommission.org/assets/1/18/ASC_Standards_Sampler.pdf

16 Health Facilities Accreditation Program, Ambulatory Surgical Center Program. (2015). Retrieved from http://www.hfap.org/AccreditationPrograms/amb_surgical.aspx

  Return to table of contents

 

 

Comprehensive Outpatient Rehabilitation Facilities

Maryland and Wyoming are the only states which require accreditation for CORFs, and Texas is the only state where facilities are ineligible for accreditation. There are two accreditation organizations for CORFs.
The Joint Commission. CORFs that seek deemed status through Joint Commission accreditation are subject to the general ambulatory care accreditation standards which were discussed in the ASC section. Disease-specific care certification is also available for the following rehabilitation programs:17

  • Amputee
  • Brain injury
  • Cardiac
  • Hip fracture
  • Intractable chronic pain
  • Multiple sclerosis
  • Oncology
  • Orthopedic
  • Parkinson’s disease
  • Pulmonary
  • Spinal cord injury
  • Stroke
  • Traumatic brain injury

Each of these rehabilitation programs is associated with clinical practice guidelines specific to the care provided. Disease-specific care certification addresses the following categories:18

  • Program management
  • Delivering or facilitating clinical care
  • Supporting self-management
  • Clinical information management
  • Performance measurement

Commission on Accreditation of Rehabilitation Facilities (CARF). CARF is an international accreditation organization whose programs cover medical and vision rehabilitation, behavioral health, aging services, child and youth services, opioid treatment, and others. CORFs may voluntarily seek accreditation through CARF,19 though CARF does not have deemed status. Its accreditation standards include several program-specific standards (e.g., adult day services, assisted living, and case management) and specialty guidelines for dementia care and stroke rehabilitation. They also require common elements for the program/service structure. The bulk of the CARF standards are organized around a quality improvement framework, addressing:

  • Leadership
  • Governance
  • Strategic planning
  • Input from persons served and other stakeholders
  • Legal requirements
  • Financial planning and management
  • Risk management
  • Health and safety
  • Human resources
  • Technology
  • Risks of persons served
  • Accessibility
  • Performance measurement and management
  • Performance improvement

_____________________________________________

17 The Joint Commission. (2015). DSC Physical Medicine/Rehabilitation. Retrieved from http://www.jointcommission.org/certification/dsc_physical_medicine_rehabilitation.aspx

18 Eickemeyer, D. (2015). Part 1: Quick Steps to Certification: Disease-Specific Care Preparation. Retrieved from http://www.jointcommission.org/assets/1/18/Quick_Steps_Webinar_10-01-2015_rev.pdf

19 Commission on Accreditation of Rehabilitation Facilities. (2015). 2015 CCAC StandardsManual. Retrieved from www.carf.org/WorkArea/DownloadAsset.aspx?id=23968

  Return to table of contents

 

 

End-Stage Renal Disease Facility

We did not identify any states that required ESRD accreditation as a condition for licensure, including California. ESRD facilities may choose to be accredited through The Joint Commission’s ambulatory care accreditation program (discussed previously) for the purpose of internal quality improvement. They may also participate in its Disease-Specific Care certification program, for ESRD care.

 

Data Limitations

Our evaluation of accreditation standards primarily drew from available online resources, including samples of specific standards, tables of contents for accreditation manuals, and informal documents (e.g., crosswalks, presentations) produced by other organizations that have done comparisons of the standards. These resources may provide only a high-level view of the standards, and they may not be fully up-to-date. We did not review accreditation and certification manuals in full detail, given their length and complexity, so these results do not represent a detailed crosswalk comparison between standards.

 Return to table of contents

 

Conclusions

Accreditation provides an alternative path to satisfy minimum CMS certification requirements, and in some cases, to meet additional state licensing requirements. We found some examples in which accreditation standards were more detailed or stringent, and/or covered additional topic areas entirely. It is unclear whether these differences materially impact the quality of care in healthcare facilities. Although research has established a link between accreditation status and
quality,20-21 the marginal value of accreditation in addition or in lieu of certification has not been
discussed in the literature.
Some states have supported accreditation as a licensure requirement, most notably in ASCs and to a very limited extent in CORFs. Policies that seek to expand state licensure in California to require accreditation for a broader set of facilities would benefit from a focused examination of those states’ experiences to date.
___________________________________________

20 Greenfield, D., & Braithwaite, J. (2008). Health sector accreditation research: A systematic review. International Journal for Quality in Health Care, 20(3), 172-183.
21 Alkhenizan, A., & Shaw, C. (2011). Impact of accreditation on the quality of healthcare services: A Systematic Review of the literature. Annals of Saudi Medicine, 31(4), 407-416.

  Return to table of contents

 

IV. Quality Concerns in ASCs, CORFs, and ESRD Facilities

 

Healthcare quality may be viewed through six distinct domains: safety, effectiveness, patient- centeredness, timeliness, efficiency, and equity.22 Government oversight of healthcare facilities generally aims to ensure that patient care meets minimally acceptable standards for quality of care through diverse means, including licensure, operating standards, regulations, accreditation, public reporting of performance, and financial mechanisms (e.g., pay for performance). To provide an evidence-based foundation for understanding where regulatory gaps in quality of care
oversight may exist, this chapter describes quality concerns from two vantages: 1) a review of the literature regarding quality concerns in ASC, CORF, and ESRD facilities, and 2) an analysis of complaints and L&C survey findings in California ASC, CORF, and ESRD facilities.

 Return to table of contents

 

Methods

Literature Review

To provide an evidence-based foundation for understanding where gaps in quality of care oversight might exist for ASC, CORF, and ESRD facilities, we conducted a systematic review of the peer-reviewed professional literature, grey literature (e.g., government and consultant reports), general literature, and news media reports. To be consistent with California’s definitions of these facilities, we excluded literature about hospital-based facilities and inpatient care settings.

Professional peer-reviewed literature. We searched PubMed for literature (all types) and the Cochrane database for systematic reviews in March 2015. The search was limited to English- language literature about human-based studies dated between January 1995 and March 2015. We excluded studies that focused narrowly on technical descriptions or evaluations of specific clinical procedures or treatments.

Although relevant to the quality domain of effectiveness, including these types of studies would entail innumerable comparative effectiveness evaluations across a broad range of clinical topics, which was beyond the scope of this analysis. We used the following search terms to identify literature that met criteria for the type of facility and the quality issue(s) of interest, with some additional exclusion criteria specific to the facility type:

Ambulatory Surgery Clinic

  • Facility keywords: ambulatory surgical clinic, ambulatory surgery center, surgicenter, ambulatory surgical procedure, surgical procedure, ambulatory care, outpatient surgery
  • Quality of care keywords: quality of care, quality of care issue, quality of health care, patient safety, medical error, postoperative complication, preoperative complication, adverse event, outcome
  • Additional exclusions: office-based surgery/procedure

Comprehensive Outpatient Rehabilitation Facility

  • Facility keywords: rehabilitation, rehabilitation center, ambulatory care, outpatient rehabilitation, occupational therapy, physical therapy
  • Quality of care keywords: quality of care, quality of care issue, quality of health care, patient safety, outcome
  • Additional exclusions: long-term care facility (including nursing home), rehabilitation facility other than physical rehabilitation (e.g. substance abuse and mental illness), tele- rehabilitation, physician-owned clinic

End-Stage Renal Disease Facility

  • Facility keywords: dialysis clinic, outpatient dialysis, hemodialysis, kidney disease, kidney failure, renal dialysis, dialysis
  • Quality of care keywords: quality of care, quality of care issue, quality of health care, patient safety, outcome, adverse event
  • Additional exclusions: Intensive care unit setting, primary care setting, kidney transplant

Grey literature. Since quality issues are frequently addressed outside of the formal peer- reviewed professional literature, we also searched the "grey literature" for information about:
1) general quality issues in ASC, CORF, and ESRD facilities, and 2) policy/regulatory analyses pertaining to quality issues in these care settings. The grey literature includes, among other things, state and federal government reports; consultant, professional association, and philanthropy sponsored reports; and trade association and manufacturer reports. We applied the same search terms and inclusion/exclusion criteria as for the peer-reviewed literature. We searched the following general grey literature sources: LexisNexis, New York Academy of Medicine grey literature database, and Congress.gov. We also conducted targeted searches of selected websites (i.e., state legislative websites, Agency for Healthcare Research and Quality, Institute of Medicine).

General literature and news reports. High-visibility cases of egregious patient safety and quality incidents may prompt licensing agency investigations and lead to new state regulations but not be documented in either peer-reviewed or grey literature reports. To capture this information, we searched LexisNexis and Google News for articles that linked new state regulatory standards to publicized cases of quality or safety incidents, using the basic query structure: “[state]” AND “law OR regulation” AND “[facility type]” AND “quality OR safety.”

Additionally, we conducted a targeted search in Google News to see whether any of the ASC, CORF, or ESRD facilities that had been frequently cited by CDPH were reported in the California news media for quality of care or safety concerns. CDPH provided us with data from its Automated Survey Processing Environment (ASPEN) system that summarized the number of complaints and incidents in the three facility types of interest between 2000 and 2014. We identified 41 facilities in this search (mostly ESRD facilities), and we searched for those facility names in connection with quality and safety keywords.

L&C Survey Findings

We analyzed data provided by L&C from ASPEN on the frequency and general nature of deficiencies and allegations that have been noted in California ASCs, CORFs, and ESRD facilities. We used the ten most recent years of data (September 16, 2005 through September 16, 2015). L&C identifies regulatory deficiencies through various activities, including surveys done for routine licensure/certification, follow-up visits to assess whether deficiencies were corrected, and responses to public complaints or entity-reported incidents. When the same deficiency was noted multiple times in a series of follow-up surveys at the same facility, it was counted once.
Multiple deficiencies are often found in a single survey, and a facility may be subject to a series of surveys for a particular issue.

We also reviewed data on allegations that were found to be substantiated with deficiencies, which are a subset of deficiency data. Allegations arise from complaints (e.g., by patients or submitted on their behalf) or incidents that facilities self-report to CDPH (e.g., breach of medical information). Detailed data about the nature of these deficiencies and allegations were not available, so only the general category or description is presented. The analysis provides a high- level, descriptive overview of the scale of compliance issues and associated quality concerns that have been documented through L&C activity.

_________________________________________

22Institute ofMedicine (2001). Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academy Press

  Return to table of contents

 

 

Results

Quality Issues from the Literature

We initially identified 2,245 sources of information about potential quality concerns in ASCs, CORFs, and ESRD facilities; 92 (4.1%) of those sources met inclusion criteria (Table 1).
Professional journal articles were the primary source of relevant information. ASCs and ESRD facilities had the largest number of sources. Very little relevant information on CORFs was found. Few pertinent news reports and policy/legislative sources were identified. We did not find any news articles discussing quality problems in the 41 selected California facilities that were most frequently cited by CDPH, with the exception of news coverage about one facility that had paradoxically received a quality award.

  Return to table of contents

 

Table 1. Literature Review Search Results

 

 

​ ​

​Reference Type

​ ​ ​ ​ ​ ​Facility Type​ ​Total ​ ​
​ ​ASCCORF​ ​ESRD​ ​
​# initial hits# included​# initial hits​# included​# initial hits​# included​# initial hits​# inlcuded​
​Journal​797​20 (2.5%)712​5 (0.7%)​​469​31 (6.6%)1,978​56 (2.8%)​
​Report/grey literature​106​9 (8.5%)​99​2 (2.0%)​4​4 (100%)​209​15 (7.2%)
​Policy/legislative​15​2 (13.3%)​1​0 (0.0%)​2​2 (100%)​N/A​4
News​​357​18 (5.0%)0​​0 (0.0%)28​​6 (21.4%)​385​24 (46.3%)
​Total​127549 (3.8%)​​8127 (0.9%​)​503​43 (8.5%)​2,59099 (3.8%)​

  Return to table of contents

  Return to table of contents

 

21 women’s experiences with care access after brain injuries. All the

24 California HealthCare Foundation. Ambulatory surgery centers: Big business, little data. California Health Care Almanac, June 2013.Retrieved fromhttp://www.chcf.org/publications/2013/06/ambulatory-surgery-centers
25 B & R Klutz Consulting. (2015). Outpatient surgery services in California: oversight, transparency, and quality.

 

 

 

 

 

  Return to table of contents

 

 

Appendix A -

State Licensing Laws

 

 

Table A1. State Licensing Laws: ASC 

​StateRegulatory Agency​Rulemaking Authority​ASC: Definition & Exclusions​State Licensure Required?​Additional State Licensure Requirements Not Addressed in Federal Standards​Additional State Detail For Existing Federal Standards (Relevant CFR​ §)
​Alabama​Alabama Department of Public Health, Bureau of Health Provider Standards, Division of Licensure and Certification​Legislature of Alabama, Code of Alabama, 1975, Sections 22-21-20, etseq.​A healthcare facility that primarily provides medically necessary or elective surgical care.
Exclusions: private doctors and dentists, including those organized as professional corporations, professional associations, partnerships, or sole proprietorships, and facilities defined as hospitals.
Abortions can only be performed at a surgical center if it is also licensed as an abortion or reproductive health center.
​Yes

​A food safety system must be in place.

Accreditation encouraged where deep sedation/ analgesia or general anesthesia is provided. The rules require registration and reporting, in addition to standards based on level of anesthesia provided.

​A copy of the governing body meeting minutes must be kept as a permanent record of the facility. (§416.41.
Governing body and management)

The Director of Nursing must be a licensed graduate of a professional nursing school with one or more years of experience in surgical/recovery nursing. (§416.46. Nursing services)

​AlaskaAlaska Department of Health and Social Services, Health Facility Licensing & Certification​AS 47.32​A facility that is not part of a hospital or general medical practice which provides surgical services to patients who do not require hospitalization.​Yes​None​None
​ArizonaArizona Department of Health Services, Division of Licensing, Bureau of Medical Facilities Licensing​9 A.A.C. 10​A facility with services for the diagnosis or treatment of patients by surgery whose recover does not require inpatient hospital care.​Yes​NoneNone​
​​ArkansasArkansas Department of Health, Health Facilities ServicesArk. Code Ann.§§20-9-201et seq., 20-7- 123​​​Outpatient surgery center means a facility in which surgical services that require the use of general or intravenous anesthetics are offered and where, in the opinion of the attending physician, hospitalization is not necessary. Minor dental surgeries are excluded from this definition.Yes The supervisor of Food and Nutrition services must be at a minimum a certified dietary manager.​The extended stay area must be staffed by at least two caregivers, one of which must be an RN (§416.52. Patient admission, assessment and discharge)
​CaliforniaCalifornia Department of Public Health

Medical Board of California (only for accredited outpatient surgical settings)
​CA HSC: 1200- 1209
HSC 1248
SB 100
​A surgical clinic is one that is not part of a hospital and provides care for patients who stay less than 24 hours.​Yes, but surgical clinics that are owned wholly or in part by physicians are regulated solely by the Medical Board of California.If the surgical procedure requires anesthesia to be administered in doses that have the probability of placing a patient's life-preserving protective reflexes, then the surgery must be performed in an accredited, licensed, or setting.

Unlicensed ASCs must be accredited only if general anesthesia is used in the clinic (California Health & Safety Code Section 1248.1), but is not needed for ASCs that operate strictly with local anesthesia or peripheral nerve blocks (Business & Professions Code Section 2216).
Accreditation is not required for clinics that use strictly anxiolytics (e.g., Xanax) and analgesics when their use is within at dosage levels that do not place patients at risk for loss of protective reflexes.
​ColoradoColorado Department of Public Health & Environment, Health Facilities Division​6 CCR 1011-1Chap 026 CCR 1011-1Chap 20​A facility which operates exclusively to provide surgical services to patients not requiring hospitalization and for patients who are not expected to require more than a total of 23 hours for preparation, the surgery itself, and recovery.
This does not include a facility that is licensed as part of a hospital.
​Yes​The license shall be for the maximum operational capacity determined by the DPH. The use of flammable anesthetics is prohibited.
​None
​ConnecticutConnecticut Department of Public HealthConnecticut General Assembly Statute Sec. 19a-493b​An outpatient surgical facility (OSF) provides surgical care requiring a medical environment that exceeds that normally found in a doctor’s office and does not require overnight stay. Common procedures include: colonoscopy, biopsy, endoscopy, eye procedures, ear/nose/throat procedures, hernia repair, and gynecological procedures.
Dental clinics are not included.
​Yes​The acronym OSF is used in Connecticut law and regulation to refer to a particular type of licensed facility. The term ASC used in federal law and regulation refers to a specific type of facility that must comply with CMS rules and accreditation standards. Connecticut has many ASCs that are licensed as OSFs, but not all OSFs are ASCs. OSFs may be free-standing or hospital owned/operated. Accredited facilities are still subject to inspection.​None
​Delaware​Delaware Department of Health and Social Services, Health Facilities Licensing and CertificationAdministrative Code Title 16 Del.C.§122(3)(p)A Free Standing Surgical Center (FSSC) is a facility, other than a hospital or the office of a physician, dentist or podiatrist, or professional association, which exists to provide surgical services that do not exceed 23 hours and 59 minutes.YesSeparate licenses are required for FSSCs maintained in separate locations and are specific for number and class of operating rooms and recovery beds. Nutritional services must be provided as detailed in the administrative code.
FSSCs may provide services through the Delaware Medical Assistance Program if the facility is certified by the Office of Health Facilities, Licensing and Certification or a comparable certifying agency in the State.
The Health Resource Board requires AAAHC or accreditation by another accrediting organization within one year of licensure as a condition of approving new or converted freestanding ambulatory centers.
A governing body with full- time director must be in place (§416.41. Governing body and management)​​
​District of ColumbiaThe Mayor of Washington, DCTitle 44 of the DC Official CodeAn ASC is a facility other than a hospital or maternity center where outpatient surgical procedures are performed. This does not include office-based facilities.YesAfter initial licensure, the Mayor may accept accreditation by a private accrediting body, federal certification in a health insurance or medical assistance program, or federal qualification of a health maintenance organization as in lieu of inspection.None​​
​FloridaFlorida Agency for Health Care Administration (AHCA)Chapter 395, Part 1, Florida Statutes;

Chapter 59A-5, Florida Administrative Code;

Chapter 59A-10, Florida Administrative Code;

Chapter 408, Part II, Florida Statutes;

Chapter 59A- 35, Florida Administrative Code
A facility with the primary purpose of providing elective surgical care, in which the patient is admitted to and discharged from such facility within the same working day and is not permitted to stay overnight, and which is not part of a hospital.YesA licensed facility shall not operate a number of beds greater than the number indicated by the agency on the face of the license without approval from the agency. Internal risk management program is required. Zoning requirements apply.A detailed emergency management plan is outlined in the administrative code (§416.41. Governing body and management)
A facility must notify each patient during admission and at discharge of his or her right to receive an itemized bill upon request. (§416.50. Patient rights)​​
​GeorgiaGeorgia Department of Community Health, Healthcare Facility Regulation Division, Office of Facility LicensureO.C.G.A. §§ 31-2-4 et seq., 31- 7-1 et seq. and 50-13-1 et seq.A facility that provides surgical treatment to patients who do not require hospitalization and does not provide accommodations for treatment. They don’t operate under the control of a hospital.
Exceptions include federally owned facilities and private physician and dentist offices.1
Service classifications include: general surgery; eye, ear, nose, and throat; plastic surgery; oral and maxillofacial; obstetrical-gynecological; oncological; ophthalmological; and urological.
YesLocations using flammable anesthetic agents shall comply with specific state regulations. All electrical work and equipment shall be designed and installed in accordance with state and local laws and ordinances. Any advertising of the services provided in or by ambulatory surgical treatment center shall include the full name of the center and its Georgia license number, as shown on the face of the permit.
An applicant for an expanded ASC must meet accreditation requirements of the AAAHC or other appropriate accrediting agency within one year of obtaining a state license.
​None
​HawaiiState of Hawaii, Department of Health, Office of Health Care AssuranceHRS §§321-9, 321-10, 321-11A freestanding surgical outpatient facility is a facility developed for the purpose of performing surgical procedures which do not require hospitalization and is not an integral part of a broad service hospital or private doctor’s office. Patients may not stay longer than 18 hours.YesA consulting dietitian shall supervise the preparation and service of whatever special diets may be deemed necessary for the patients to meet the objectives of the facility.
There shall be written policies covering whatever dietetic services are deemed necessary by the governing board.
None​​
​IdahoIdaho Department of Health and Welfare, Division of Licensing and CertificationNo statutes apply​An ASC operates exclusively to provide surgical services to those not requiring hospitalization.​No
​None
​None
​IllinoisIllinois Department of Public Health, Office of Health Care Regulation210 ILCS 5Any facility that meets the definition of ASC under CMS rules. The facility shall not provide accommodations for overnight stays.
An ambulatory surgical treatment center (ASTC) includes facilities in which a procedure is used to terminate a pregnancy.
Yes​NoneNone​​
​IndianaIndiana State Department of Health, Division of Acute CareIC 16-21-1-7; IC 16-21-1-9An ASC specializes in surgery, pain management and certain diagnostic (e.g., colonoscopy) services in an outpatient setting. These procedures are more intensive than those done in a typical doctor’s office, but not so much so that hospitalization is required.YesA short stay record form must be used. The details contained in this form (identification data, medical history, etc.) mirror CFR requirements for patient record keeping, but the term “short stay record from” is unique to Indiana.None​​

 

 

 

Page Last Updated :