REGULATORY ENTITIES Agencies that Regulate Washington Hospitals ..........................2 Joint Commission on Accreditation of Healthcare Organizations ..............................................................

3 Washington Hospital Licensing Standards.................................4 Medicare Conditions of Participation ..........................................5 Summary of Primary Hospital Regulatory and Accrediting Entities ............................................7 Other State and Federal Regulations............................................7 Local Regulations............................................................................8 Summary ..........................................................................................8 References ........................................................................................9

Hospitals must comply with a number of regulations to carry out state and federal laws. The two primary reasons for health care regulations are the protection of the health and safety of patients and the governments major role in paying for health care, through Medicare and Medicaid programs. In addition to providing a range of health care services, hospitals must obtain multiple licenses and undergo numerous surveys. For example, a hospital that offers acute care, home health care, hospice care and long-term care must have

3 separate surveys and a different license for each service. This is in addition to the hospitals license and Medicare certification. Trustees should also have an understanding of the cost of complying with regulations. Often, compliance requires the purchase of special supplies, hiring of additional staff, architectural changes to a facility or the provision of services that are costly to maintain. JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS For decades, hospitals participated in a voluntary self-regulatory process. In the early 1950s, a program of hospital self-inspection, sponsored by the American College of Surgeons, began expanding into the present Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Originally, the Joint Commission surveyed and accredited only hospitals. Today JCAHO accreditation includes critical access hospitals, pathology and clinical laboratory services, home health agencies, behavioral health care services, long-term care facilities, ambulatory care centers, health care networks and managed care. The Joint Commission conducts a voluntary survey program of hospitals. A hospital must request and pay for a survey. Approximately two-thirds of hospitals in Washington state are accredited by JCAHO. More information about JCAHO accreditation can be found on the JCAHO website, www.jointcommission.org
JCAHO SURVEY AND STANDARDS OVERVIEW

A multi-disciplinary inspection team spends at least two days in the hospital. Standards that measure plant safety, medical staff, quality assurance, department services and what the hospital is doing to improve the quality of its services are used. The Joint Commission wants to see mechanisms and processes in place to ensure that the Board has an oversight role in the credentialing of the medical staff, quality assurance and continuous improvements of the care provided by the hospital. The Joint Commission awards a three-year accreditation to hospitals that meet its standards. In some cases, it makes receiving accreditation part of meeting certain standards between surveys. If these standards are not met, conditional accreditation or denial of accreditation can result. Costs related to maintaining JCAHO accreditation include a fee for the survey itself and expenses related to the cost of training, publications, seminars and consultants. Hospitals that are accredited are automatically eligible to participate in the Medicare program. Accreditation or Medicare certification is required for participating in most managed care programs.

The Governing Board must be an active participant in the accreditation process. The JCAHO standards manual includes specific standards for the governing body (see appendix). Board members must be familiar with these standards and their requirements. Some of these requirements are: Credentialing of the medical staff Board self-evaluation Orientation of new Board members Continuing education for the Board Adopting bylaws Conflict of interest statements Performance improvement The Joint Commission wants to see mechanisms and processes in place to ensure that the Board has an oversight role in the credentialing of medical staff, quality assurance and continuous improvements of the care provided by the hospital. During the survey, the Board should meet with the survey team. It is important for Board members to participate in the exit conference with the team and hear its recommendations. The CEO should supply the Board with the written report from the JCAHO survey along with a plan for carrying out the recommendations. The Joint Commission is conducting unannounced surveys instead of scheduled surveys, except for initial surveys. The hospital does not receive notice of its survey date. WASHINGTON STATE LICENSING STANDARDS Hospitals in Washington must be licensed by the state in order to operate. Revised State licensing regulations (246-320 WAC, 70.41 RCW), modeled after the JCAHO standards, came into effect in March, 1999. The regulations are now outcome-based and streamlined. In Washington state there are separate licensing standards for specialty hospitals, such as psychiatric and chemical dependency facilities. Key sections of the state licensing standards are noted below (see the appendix for the governance section of the state licensing standards): Governance Leadership Management of human resources Medical staff

5 Management of information Improving organizational performance Patient rights and organizational ethics Infection control program Regulations for the range of services a hospital provides, such as pharmaceutical, diagnostic, inpatient and outpatient and specialized care Management of environment for care (assures a safe environment for patients, staff and visitors) Design, construction review and plan approval Facility requirements (for clinical, non-clinical and specialized services areas) All Washington state hospitals participate in the state licensing survey process which occurs every 18 months for non-JCAHO hospitals. JCAHO accredited hospitals are surveyed by the state once every 3 years because the JCAHO accreditation survey substitutes a licensing survey. Once the survey is complete, the Board should receive a copy of the findings along with recommendations for correction of any problems. MEDICARE CONDITIONS OF PARTICIPATION The Medicare Program is the primary source of health care payment for the nations and states elderly population. Medicare is a federal program authorized by Title 19 of the Social Security Act (also see finance chapter). Hospitals that participate in the Medicare program must be certified. In order to be Medicare-certified, a hospital must comply with the Medicare Conditions of Participation. These conditions set forth the standards for health care provided to Medicare beneficiaries in the hospital setting. If a hospital meets the standards for Medicare certification, this qualifies the hospital for participation in the Medicaid program. The hospital is not required to undergo an additional survey to qualify to participate in the Medicaid program. The Medicare Conditions of Participation contain requirements regarding the governance and administration of hospitals, patients rights, quality assurance and utilization review, required and optional services and requirements for staffing. The Conditions of Participation require the medical staff be composed of physicians and allow the Governing Board to appoint other practitioners to the medical staff. All patients in a Medicare-certified hospital must be under the care of a physician and a physician must be on call 24 hours a day. The hospital must have nursing services on a 24-hour basis, and all nursing care must be provided or supervised by a registered nurse (RN). Critical Access Hospitals do not have to be open 24-hours a day and seven days per week, they may staff with

6 mid-levels, and do not always need an RN if they receive a state licensure waiver. There are several services that Medicare-certified hospitals must either provide within the facility or make available through a contractual or consulting arrangement. These include: Pharmaceutical services Diagnostic radiology services Clinical lab services Dietary services The Conditions of Participation establish standards for optional services for Medicare-certified hospitals. These include surgery, anesthesia services, outpatient services and rehabilitation, nuclear medicine and respiratory care. Medicare-certified hospitals are not required to provide emergency medical services, but must have written policies appraising, treating and referring patients needing emergency care. Standards for the physical environment are not as stringent as the facility requirements in the states Hospital Licensing Standards.
SURVEY PROCESS

The Washington State Department of Health conducts Medicare certification surveys under a contract with the Centers for Medicare & Medicaid services, www.cms.gov/. Each year a few randomly selected hospitals that are JCAHO accredited undergo a validation survey while non-JCAHO hospitals usually participate in a Medicare Certification Survey. The Medicare certification and the hospital licensing surveys are generally conducted at the same time. The hospital is notified of the date that its Medicare survey will occur. The only time a hospital survey is unannounced is when the Department of Health has received a complaint.

7 SUMMARY OF PRIMARY HOSPITAL REGULATORY AND ACCREDITING ENTITIES

Standard

Washington State Hospital Licensing Standards (all hospitals in WA state must be licensed)

Medicare Conditions of Participation (required if a hospital desires to treat Medicare patients)

JCAHO Accreditation

(voluntary selfregulation)

Agency/ organization

Washington State Department of Health

Centers for Medicare & Medicaid Services

Joint Commission on Accreditation of Health Care Organizations

Survey

Every 18 months; if the survey occurs in the same year as a JCAHO survey, the hospital may request an exclusion

Every 3 years; Medicare Certification can be obtained via a validation survey (for JCAHO accredited hospitals)

Surveys are performed every three years

OTHER STATE AND FEDERAL REGULATIONS The Washington State Department of Health is involved in many hospital activities including hazardous waste management, construction and remodeling of facilities, infection control practices, medical device reporting, gathering and compilation of health statistics, reporting of births, inspection of radiographic machines, inspection of clinical laboratories and communicable disease reporting. The Department of Social and Health Services (DSHS), www.wa.gov/dshs/, monitors the care provided to patients in nursing homes and long-term care

8 facilities. Staff conduct unannounced, on-site inspections on a regular basis and investigate complaints. Workers' compensation in Washington state is regulated by the Department of Labor and Industries. Its sets the fee schedules for physicians, x-ray, and diagnostic tests for hospital outpatient fees and sets what is called the Percentage of Allowed Charges (POAC) for self-insured hospitals to pay. Nongovernmental hospitals come under the jurisdiction of the U.S. Occupational Health and Safety Administration for the prevention of job-related accidents and illnesses. All hospitals must comply with federal requirements related to non-discrimination on the basis of age, sex, race, national origin, religion and handicap. A special area of concern for hospitals is the requirements of the Americans with Disabilities Act. Hospitals must be fully accessible for visitors, employees and patients. All hospital services must be accessible. This means that information may need to be available in Braille or large type, and by telecommunication devices and sign language. Physicians, nurses, radiological technologists, nursing home administrators, pharmacists, social workers, respiratory therapists, physical therapists, dietitians and physicians assistants must be licensed or certified by state boards before they can practice in their fields. LOCAL REGULATIONS Hospitals are also subject to local regulations including local building codes, fire safety regulations, food sanitation codes and zoning regulations. In urban areas, compliance with these regulations can be costly and complicated. In some rural areas, the effect of these regulations is minimal. SUMMARY Trustees need to have an understanding of regulatory agencies and the importance of compliance with their regulations. A special challenge of the Board is to respond to this oversight in a positive and cost-effective manner.

9 REFERENCES
Bailey, Charles, General Counsel, THA-The Association of Texas Hospitals and Health Care Organizations, Austin, TX, January, 1998. Brown, Fletcher, Shareholder, Davis & Wilkerson P.C., Austin TX, January, 2006. Claymon, Jennifer, Associate, Davis & Wilkerson, P.C., Austin, TX, January, 2006. DSHS (AASA) website, www.wa.gov/dshs/index.html Griffith, Richard and Dewey Johnson, Texas Hospital Law, Austin, TX: Butterworth Legal Publishers, 1990. Health and Safety Code, Vol. 1 and 2, Titles 1 to 5, Vernons Texas Codes Annotated, St. Paul, MN: West Publishing Co., 1992 and 1998 supplement. Hospital Licensing Rules, 25 TAC 133; Psychiatric Hospital Licensing Rules, 25 TAC 134. Joint Commission on Accreditation of Healthcare Organizations, 2006 Comprehensive Accreditation Manual for Hospitals: The Official Handbook, Oakbrook Terrace, IL, 2006. McGuire, Catherine, Mary Walker, and Deborah Molsberry, Rural Hospital Models and Recommendations for Their Implementation, Austin, TX: Health Care Options for Rural Communities, August, 1993. Reed, Kevin, Shareholder, Davis & Wilkerson P.C., Austin, TX, January 2006. Suiter, Brenda, Director, Rural and Public Health, Washington State Hospital Association, Seattle, WA, September 2006.. Sjoberg, Elizabeth, Staff Attorney, THA-The Association of Texas Hospitals and Health Care Organizations, Austin, TX, January, 1998. Wagner, Carol, Director, Patient Safety, Washington State Hospital Association, Seattle, WA, September 2006.