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.

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

This publication was prepared by the Institute for Population Health Improvement, University of California Davis
4800 2nd Ave., Suite 2600
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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

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.

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Acronyms

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I. Background

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.

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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

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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.

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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.

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

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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.

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

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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.

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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). 

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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.

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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).

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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.

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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.

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III. Accreditation Standards

Accreditation provides an alternative approach to external quality oversight for healthcare facilities. CMS grants certain accrediting organizations authority to deem a facility as meeting minimum standards. Currently, ASCs and CORFs are eligible for this process, but not ESRD facilities. Accredited facilities satisfy minimum CMS’ certification requirements by virtue of their deemed status. Facilities may opt for accreditation instead of certification, and the accreditation process can include quality improvement support that the regulatory certification/licensure survey process typically does not. Some states require accreditation as a condition of licensure. A consideration of whether the current state regulatory provisions are adequate should consider accreditation standards, which may be used in lieu of federal certification standards. This chapter describes the various organizations that accredit ASC, CORF, and ESRD facilities, and it compares their respective standards with the CMS requirements.

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Methods

To identify additional external quality oversight standards, we conducted targeted searches and consulted with industry experts on regulation in these settings. We first conducted Internet searches (between August and October 2015) to identify accreditation organizations for ASC, CORF, and ESRD facilities. We focused primarily on organizations that had deemed status from CMS, and sought resources that compared accreditation and certification standards (e.g., recent crosswalk comparisons done by professional groups, and examples of selected content from standards manuals – the full accreditation standard manuals were typically not available online).

Accreditation standards are usually lengthy, sometimes encompassing hundreds of pages and multiple manuals. A line-by-line comparison was not practical, and we did not obtain the full accreditation manuals if they were not readily available. Instead, we used selected examples to get a general sense of how CMS and accreditation standards may differ.

We met with staff from professional and industry groups that represent ASC, CORF, and ESRD facilities, and who have a strong working knowledge of regulations in those settings. These groups included the California Ambulatory Surgery Association and California Medical Association for ASCs and the Health Services Advisory Group (California ESRD Network 18) for ESRD facilities. While we also contacted DaVita Kidney Care, a major dialysis provider, we did not receive a response. No professional organizations specifically for CORFs were identified. CDPH’s L&C subject matter expert staff provided interim feedback as well. We used these meetings to learn about the regulations and quality oversight processes, validate our understanding of accreditation issues, and identify relevant resources that compared accreditation and CMS standards. 

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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

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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

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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

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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

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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.

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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.
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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.

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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.

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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.

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

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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.

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Table 1. Literature Review Search Results

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Ambulatory Surgery Clinics

We identified and reviewed 49 relevant sources about quality concerns in ASCs (Appendix B, Table B1). We organized the information into pre-, peri-, and post-surgical issues. Pre-surgery- themed literature that we identified addressed candidate selection for outpatient surgery and preoperative testing, with a goal of ensuring that care was clinically appropriate for the ASC setting. Literature concerning peri-operative issues included patient burns, prophylactic intravenous antibiotic timing, patient falls, and adverse events. Post-surgical quality issues focused on nausea/vomiting, pain control, and unanticipated hospital admission. The overwhelming majority of the initially identified sources were excluded because they were not relevant to the issues we were evaluating. For instance, they were reports about clinical or technical studies (e.g., randomized controlled trials comparing two forms of anesthesia medication).

The journal articles that we included primarily addressed the quality domains of efficiency, safety, and effectiveness, with limited to no discussion of the other quality domains. Reports primarily concentrated on safety and general oversight issues, while news articles and legislative/policy documents focused primarily on safety.

Safety. We reviewed five journal articles and five reports that described safety issues in ASCs. The journal articles primarily addressed adverse events, patient screening and selection for outpatient surgery, and surgical site infection (SSI). The reports provided recommendations on how to reduce adverse events and SSIs. We included 14 news reports, which primarily discussed infection and general safety concerns and deaths following lap-band surgery and the highly publicized death of comedian Joan Rivers. We also included two legislative/policy documents that described the regulatory environment in Washington and Oregon.

A 2008 study of 1.14 million ambulatory surgical procedures found that procedures performed by board-certified surgeons in accredited ASCs had mortality rates comparable to hospitals. A more recent study of national day-case surgery data had similar findings. However, state reports of adverse events raised concerns about the occurrence of serious safety events (e.g., SSIs, retained surgical items, and wrong patient, site, or procedure surgery) in ASCs. These are also concerns in the hospital setting. Data from one analysis of medical errors concluded that death from office-based lipoplasty was unacceptably high. A sixth journal article that we found incidentally, but which did not appear in our search results, noted that in seven years of mandatory adverse event reporting for medical office-based procedures in Florida, there were 174 events and 31 deaths.23 Plastic surgery procedures accounted for most of the deaths.

Numerous sources addressed SSI and concerns about noncompliance with facility and physician oversight standards. Several news reports highlighted non-compliance with infection control requirements. One report noted that state inspectors found more “immediate jeopardy” level safety concerns in unlicensed ASCs than in licensed ASCs. Some reports cited concerns about inadequate training or equipment to deal with emergencies, insufficient facility or practitioner competence to perform complex or risky procedures, and the lack of practitioner oversight and peer review.

Effectiveness. We reviewed eight journal articles on effectiveness. They addressed post- operative unplanned hospital admissions and pain management issues; peri-operative adverse events; and pre-operative patient anxiety.
General surgery, gynecology, urology, and orthopedic procedures done in ASCs account for the vast majority of unplanned hospital admissions; plastic surgery has a relatively low rate of admissions. Common reasons for unplanned hospital admission after an ASC procedure were bleeding and wound management issues, cardiopulmonary problems, nausea and vomiting, and pain. Multiple reports cited problems with patients experiencing nausea, vomiting, and/or pain after ASC procedures. Hospital admissions following ASC procedures were frequently initiated through the emergency department. Better ASC postoperative management and patient discharge procedures could reduce the need for these admissions.

Patient-centeredness. Literature on patient-centeredness was limited. We included only one journal article, which reported on patient satisfaction in freestanding ASCs compared to hospital- based ASCs. Patient satisfaction and anxiety were reported to be similar between hospital and ASC-based procedures.

Timeliness. We did not find any literature addressing this quality domain.

Efficiency. We reviewed six journal articles on efficiency – three reviews and three original analyses. Several articles addressed the appropriate and efficient use of pre-operative patient evaluations to assess candidacy for outpatient surgery. One journal article evaluated whether pre- operative anxiety medication delayed discharge, and another examined the link between ASC structure and specialization with quality outcomes.

Some studies raised concerns about potential overuse of pre-operative testing. Pre-operative testing occurs in the majority of patients undergoing elective surgery, even if the patient does not present with comorbidities that offer clear indications for it (e.g., as outlined by the National Surgical Quality Improvement Program). However, abnormal results in preoperative tests performed in ambulatory surgery settings rarely prompt management changes or affect patient outcomes. The reports did not allow us to determine whether overuse of pre-operative testing was due to practice traditions, lack of communication between physicians, fear of malpractice litigation, or lack of awareness of evidence and guidelines.

Equity. We did not find any literature addressing this quality domain.
General. We reviewed four reports and four news stories about general patient safety policy issues. Three of the reports were highly relevant investigations by the Office of the Inspector General (OIG), U.S. Department of Health and Human Services, which evaluated whether government and accreditation agency oversight of ASCs was adequate; one report described state licensing issues in New Jersey. The news reports highlighted concerns about the adequacy of state regulatory oversight.

The OIG raised numerous concerns in its 2002 reports about the adequacy of existing ASC oversight, urging stronger oversight by federal and state regulators and accrediting bodies. The report noted that outpatient surgery is increasingly common, and that the procedures being performed in these settings are increasingly complex and high-risk. The OIG called for, at a minimum, changes to the CMS Conditions of Coverage to include patient rights and continuous quality improvement. The OIG concluded that “Medicare’s system of quality oversight is not up to the task,” and it urged CMS to hold state agencies and accreditors accountable for noncompliance. CMS standards for ASCs have been extensively revised and expanded since the 2002 OIG reports were released.

General news stories reported on the citation of numerous licensed facilities for “immediate jeopardy violations” and safety concerns due to unlicensed clinical practices. Both the OIG and the news media reports advocated for more comprehensive regulations and more meaningful compliance with those standards.

The California HealthCare Foundation produced two reports which were not captured in our review but are relevant. The first was a brief that highlighted the growing need for, but lack of, public data about outpatient surgery.24 The second was a report that outlined the regulatory structure for all outpatient surgery settings in California (including but not limited to ASCs). It noted the complex patchwork of state requirements and described multiple opportunities for regulatory improvements.25 The work raises important points about the need for better regulatory consistency across various outpatient surgery settings, and it addresses topics that were outside the scope of our analysis – which focused on regulatory opportunities within the current framework of CDPH oversight.

Comprehensive Outpatient Rehabilitation Facilities

We reviewed seven journal reports about quality concerns in CORFs (Appendix B, Table B2). There were no news reports, policy evaluations, or other relevant sources. Literature regarding quality in CORFs was sparse, with 99% of the initially identified literature failing to meet inclusion criteria. Many of the excluded results pertained to mental health and drug abuse rehabilitation facilities or descriptions of specific therapeutic methods.

Access to care was the most common topic discussed in the CORF-related literature, and access issues spanned multiple quality domains. Topics included clinical education of caregivers, racial/ethnic disparities in stroke rehabilitation, outcome measures, research needs, and adherence to clinical guidelines. A few sources addressed patient-centeredness and effectiveness, but there was almost nothing on the other quality domains for CORFs.

Safety. We did not find any literature addressing safety.

Effectiveness. We reviewed two journal articles and one report about effectiveness. These sources discussed clinical education about rehabilitation needs, state regulation of allied health professional practice, and research needs for measurement.

The journal articles asserted that quality of care in CORFs was compromised by insufficient rehabilitation training for resident physicians, particularly in cancer-survivor populations. One journal article cautioned about whether states should allow physical therapists to be substituted with physical therapy assistants and therapy aids, which may decrease care quality. A report about a two-day symposium to discuss the state-of-the-science on post-acute care rehabilitation noted that little is known about how to achieve optimal outcomes and cited the need for more research.

Patient-centeredness. We identified one journal article related to patient-centeredness, which reported on a survey of women faced barriers to rehabilitation care access, including cost, transportation, knowledge, and coordination of care issues. These barriers may result in underuse of services.

Timeliness. We identified one journal article relating to timeliness. It examined whether stroke survivors received timely and adequate care, finding that patient outcomes and quality of life could be improved if more patients received recommended care.

Efficiency. We did not find any literature addressing efficiency.

Equity. We identified one journal article relating to equity. It described widespread racial and ethnic disparities in stroke care, including use of outpatient rehabilitation, access, treatment quality, and research participation.

General. We reviewed one journal article about general quality issues. It reviewed various outcome measures for rehabilitation care and discussed the challenges in achieving consensus around a common set of standards.

End-Stage Renal Disease Facilities

We reviewed 43 literature sources discussing quality concerns in ESRD facilities, and discarded 91% of the sources (Appendix B, Table B3). The excluded results could not be linked to one of the six quality domains and discussed topics such as Medicare reimbursement rate schedules, laboratory experimentation, and genetic factors. We included 31 journal articles, four reports, six news reports, and two policy/legislative documents. Most literature fell under the quality domain of effectiveness, though we found information in all quality domains except timeliness. Common topics in ESRD facilities were quality measurement, organizational structure (e.g., non-profit vs. for-profit status), vascular access, and adverse events. News media reports heavily focused on safety issues due to faulty equipment or non-compliance with CMS guidelines.

The Institute of Medicine Committee for the Study of the Medicare End-Stage Renal Disease Program published a seminal 1991 report about the government’s role in ESRD facility quality.26 This was outside of our search timeframe for inclusion, but it is worth noting since the report formed the basis for much of the current regulatory oversight that is in place. The report detailed
concerns about disparities in access to care, declining quality in the face of diminished reimbursement, and quality oversight needs.

Safety. We reviewed two journal articles, six news reports, and two policy/legislative documents related to safety. One journal article and one report discussed the epidemiology of healthcare- associated infections in ESRD facilities. The type of vascular access used for dialysis is related to infection. The second journal article reported on vascular access complications based on thetechnology at the time, though it was published nearly 20 years ago and is of uncertain relevance today; the other journal article described more recent vascular access infection risk factors.

News media reports discussed several serious adverse event incidents, which were linked to employee error, defective equipment, and continued use of recalled products. A number of news reports recounted an instance of healthcare serial murder in Texas at a dialysis clinic; this instance was also described in a peer-reviewed journal article on healthcare serial murder.27 One report pointed to disproportionately high morbidity in some San Gabriel Valley clinics that had inspection citations. Others raised general concerns following ESRD facility conversion from non-profit to for-profit. A Government Accountability Organization (GAO) report further substantiated news report concerns about noncompliance, finding that many facilities surveyed
for Medicare participation should have been terminated from the program due to serious quality problems. Moreover, state inspections were not frequent enough to detect or result in correction of many violations.

Effectiveness. We included 17 journal articles and four other reports about effectiveness. The prevailing topic within effectiveness was quality measures, though organizational structure, dialyzer reuse, vascular access, and dialysis care issues were also discussed.

Multiple studies linked improved efficiency and patient outcomes to better performance on quality of care measures and closer adherence to clinical guidelines. A number of reports found that many ESRD facilities failed to meet minimum clinical targets. Serious problems identified during inspections included medication errors and water contamination – problems that, if left uncorrected, could lead to termination from Medicare participation. A 2010 panel recommended several additional areas for measurement of ESRD care quality.

Studies found mixed results about the relationship between mortality and facility for-profit/not for profit status, but a systematic review concluded that mortality was higher in private for-profit facilities than in non-profit facilities. Other studies linked higher mortality in dialysis care to factors such as less physician supervision; free standing instead of hospital-based clinic structure (though authors noted that their findings differed from a prior study); lower dialysis adequacy (as measured by urea reduction ratio); type of vascular access method (catheter and graft-based access were reported to be problematic); ongoing vascular access monitoring; and pre- and post- dialysis care.

Patient-centeredness. We reviewed one journal article on this quality domain; it addressed patient satisfaction. The study found that patient satisfaction increased with greater nurse-patient interaction, more information and instruction provided by staff, a more personalized atmosphere of the facility, and the efficiency of delivery of the dialysis supplies. The dialysis regimen itself was the greatest cause of patient dissatisfaction.

Timeliness. We did not find any information on this quality domain.

Efficiency. We reviewed four journal articles focusing on efficiency. Three of the articles explored issues relating to staffing levels, and one discussed Medicare reimbursement changes.

Studies found large regional differences in patient-nurse staffing ratios, and staffing levels were significantly associated with clinical outcomes. High patient-to-nurse ratios were linked to an increased number of adverse events. Medicare reimbursement changes in 2005 were not linked to changes in clinical qualitymeasures.
Equity. We included five journal articles pertaining to equity. These articles addressed issues of access to care and quality measures.

Dialysis care access varies widely based on patient characteristics, and even after controlling for these variables across facility types. One study found variation in ESRD care access that was linked to gender, race, and hemoglobin and serum albumin levels, as well as clear regional variations in catheter utilization. Another study found that physician visit volume was driven by geography and facility location, rather than patient health status or illness acuity; patients had fewer nephrologist visits in small towns and rural areas compared to large towns and urban areas. In addition, facility quality and patient survival were shown in one study to be markedly worse in neighborhoods with a higher proportion of African-Americans.

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Compliance Violations in California: L&C Survey Findings

In order for regulatory oversight of healthcare facilities to be effective, the standards must be comprehensive and well-defined, and facilities must comply with those standards. The focus of this study is the former, but much of the literature addresses problems with the latter. As such, we also report on the number of compliance violations which resulted in federal or state deficiencies that have been identified in L&C surveys (Figures C1-C3). The data represent issues that L&C found via on-site surveys, including those that were part of routine surveillance and in response to consumer complaints, over a ten-year period, September 2005 to September 2015.
These issues represent opportunities to improve quality and general facility conditions in ASCs, CORFs, and ESRD facilities that do not entail new requirements, but rather through improvements for known compliance problems.

Ambulatory Surgery Clinics. L&C identified 16,592 discrete deficiencies in 564 ASCs between September 2005 and September 2015, an average of 1,659 per year (Figure C1). The majority (73%) were federal deficiencies, and a minority (15%) violated CMS conditions of participation. State deficiencies usually cited violations of the life safety code standards (e.g., building fire codes); these are also part of federal standards, but CMS may defer to existing state rules. Federal deficiencies were diverse, but commonly involved drug administration or infection- related measures.

Of the deficiencies that L&C identified in substantiated allegations (n=155, averaging about 16 per year), quality of care was the general type of allegation that surveyors cited most often.
Examples of the most serious allegations included surgical and procedural adverse events: three wrong part surgeries, two wrong procedures, and one death linked to anesthesia in an otherwise healthy patient, over 10 years. Acute care hospitals report many more surgical adverse events than ASCs: more than 600 substantiated retained surgical items in seven years of reporting, though some of these cases may not have deficiencies;28 compared to zero retained surgical
items in ASCs that were substantiated with deficiencies. Importantly, from the information available, we could not determine whether the low number of adverse events reported from ASCs was due to reporting practices and requirements or truly fewer events. Physician-owned ASCs were only required to report adverse events to CDPH between 2012 and 2014; they are currently required to report adverse events to the Medical Board of California. Compliance with the reporting requirement is unclear, although non-reporting is generally believed to be widespread.

Comprehensive Outpatient Rehabilitation Facilities. L&C identified 2,272 discrete deficiencies in 122 CORFs between September 2005 and September 2015, an average of 227 per year (Figure C2). In contrast to ASCs, the overwhelming majority (98%) were state deficiencies. A minority (11%) violated CMS conditions of participation. (State and CMS COP deficiencies are not mutually exclusive, resulting in the total of the two categories exceeding 100%.) State deficiencies often cited non-compliance with policies, such as those pertaining to patient care or personnel. Few noteworthy allegations were documented for CORFs, less than one per year on average.

End-Stage Renal Disease Facilities. L&C identified 9,591 discrete deficiencies in 537 ESRD facilities between September 2005 and September 2015, an average of about 959 per year (Figure C3). The majority (98%) were federal deficiencies, and a small minority (2%) violated CMS conditions of participation. State deficiencies usually cited violations of the life safety code standards (e.g., building fire codes); these are also part of federal standards, but CMS may defer to existing state rules. Federal deficiencies were diverse, but commonly addressed infection control and prevention, though compared to the other two settings, clinically pertinent topics such as the appropriateness of dialysis treatment were also frequently cited.

Of the deficiencies L&C identified in substantiated allegations (n=792, averaging about 79 per year), quality of care was the general type of allegation that surveyors cited most often. Among the potentially serious allegations were 14 general patient safety-related incidents, as well as two instances of sexual abuse, two patient falls, and one contaminated drug/device cases. Reporting practices may influence these numbers and mask their true frequency.

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Data Limitations

The literature about quality of care issues in ASCs, CORFs, and ESRD facilities was relatively limited. We included sources that ranged from rigorously designed, peer-reviewed journal articles to news reports about a single patient. We felt these were illustrative of the range of quality concerns that merit consideration by policymakers. Peer-reviewed studies are valuable in understanding population-level trends, but they may aggregate or analyze data in a manner that does not recognize the rare safety hazards that regulators seek to eliminate – i.e., regardless of whether risk is significantly higher in ambulatory or hospital-based settings. Our search terms were designed to support an efficient search without excessive irrelevant hits, but they may also have missed some relevant sources.

The analysis of compliance violations in California relied upon L&C survey data. This only captures what L&C is able to detect during on-site surveys, including those that occurred as part of routine surveillance or in response to consumer complaints. It does not capture any additional issues that escaped L&C detection, non-reporting by healthcare facilities, or problems that could not be cited as deficiencies due to regulatory gaps or insufficient evidence to issue a citation. Experience in other healthcare settings suggests that under-reporting of patient safety events is widespread.29 Given these limitations, the L&C-detected issues may not be representative of the full scope of quality concerns.
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23 Coldiron, B. M., Healy, C., & Bene, N. I. (2008). Office surgery incidents:What seven years of Florida data show us. Dermatologic Surgery, 34(3), 285-291.

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.

26 Institute ofMedicine Committee for the Study of theMedicare End-Stage Renal Disease Program. (1991). Kidney Failure and the Federal Government. In R. A. Rettig & N. G. Levinsky (Eds.).Washington, DC: National Academies Press.

27 Kizer, K. W. & Yorker, B. C. (2010). Health care serial murder: A patient safety orphan. The Joint Commission Journal on Quality and Patient Safety, 36(4), 186-191.

28Wu, H. W. & Kizer, K. W. (2016). Surgical adverse events in California: Trends in state reporting and recommendations for prevention. Sacramento, CA: Institute for Population Health Improvement, University of California Davis Health System. (In press). 

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Conclusions

Overall, we found a modest body of literature describing quality of care concerns in ASCs and ESRD facilities, and very little information about quality issues in CORFs. We identified opportunities for improved clinical practice in these facilities, ranging from reducing surgical site infections in ASCs to selecting better methods of vascular access for dialysis. Serious adverse events were identified, particularly in ASCs. In ESRD facilities, safety concerns included those involving defective equipment and products. Serious safety incidents in CORFs appear to be less likely due to the nature of services provided in those settings.

Much of the literature discussed quality issues that may be more appropriately addressed through adherence to evidence-based standards, clinical practice guidelines, and other clinical practice improvements, such as prevention of infections and complications. Some of the literature detailed serious adverse events, which merit closer scrutiny from a regulatory perspective. Because California currently requires only hospitals to report adverse events to CDPH and physician-owned ASCs to report to the Medical Board of California, ASCs, CORFs, and ESRD facilities will only report to CDPH on these adverse events if they operate under a hospital’s license. News media reports about unexpected patient deaths frequently pointed to the vulnerabilities of the current regulatory structure.

The literature that most directly considered our primary question – i.e., whether existing standards used in California fully capture the quality issues that occur in these facilities – largely detailed regulators’ struggles to ensure meaningful compliance with the existing minimum standards, rather than discussing whether broader standards were needed. Taken together with data from L&C that describes the universe of known compliance violations, one should be cautious about generalizing about the full spectrum of underlying quality issues. Overall, the literature offers little evidence-based guidance about the utility and likely benefit of expanded regulatory oversight of ASCs, CORFs, and ERSD facilities, and known compliance violations may represent only a portion of the problem.

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29 Institute ofMedicine Committee on Quality of Health Care in America. (2000). To err is human: Building a safer health system. In Kohn, L. T., Corrigan, J. M. & Donaldson, M. S. (Eds.).Washington, DC: National Academies Press.

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V. Study Conclusions

This study sought to determine the adequacy of federal certification standards as the sole basis for state licensing of ASC, CORF, and ESRD facilities. It evaluated this question by first examining the regulatory and oversight provisions for these facilities in other states to determine whether there are examples of stronger state regulation. We found an array of additional regulations in other states, although primarily for ASC and ESRD facilities. These state-specific regulatory differences were largely semantic rather than substantive, except for matters of environmental and occupational safety in which cases CMS often defers to state requirements. We found relatively few requirements for CORFs, possibly because their scope of services does not present unique safety threats. While we found various regulatory opportunities in some state- specific requirements, no single issue emerged as a common priority among multiple states.

The noteworthy differences between licensure in California compared to other states pertain to requirements for accreditation and variations on how facilities and services are defined and regulated. These differences have consequences for various oversight provisions, such as adverse event reporting. Further details about particular topics are provided in the appendices.

State oversight for outpatient procedures performed in California is a patchwork of regulations. In the case of ASCs, for example, physician-owned facilities are regulated by a different entity than hospital-owned facilities. This has received considerable attention and is detailed elsewhere.3 It is unclear from the evidence we examined whether the incremental benefit of expanding accreditation requirements would materially improve quality of care.

Next, we considered what quality concerns and problems have been documented in diverse information sources, ranging from peer-reviewed publications to general news media coverage. We cast a wide net, aiming to identify gaps that might signal a need for stronger regulatory oversight. We found areas for clinical practice improvement in ASC and ESRD facilities, which are often under the purview of professional guidelines rather than state regulatory requirements. It also identified an assortment of safety concerns in ASC and ESRD facilities, but these usually were attributed to non-compliance with existing standards rather than a need for expanded regulations. For example, the quality literature frequently addresses infection, but survey activity data from CDPH show that facilities are often deficient in meeting existing infection control standards.

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; and
• Future consideration of the need for expanded regulatory oversight of ASCs, CORFs 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.

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Appendix A -

State Licensing Laws

Table A1. State Licensing Laws: ASC