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Current through the end of the 2007 Regular Session
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Title 44 - Health
CHAPTER 7.
HOSPITALS, TUBERCULOSIS CAMPS AND HEALTH SERVICES DISTRICTS
ARTICLE 1.
GENERAL PROVISIONS
SECTION 44-7-10. Public hospitals may maintain eye banks.
Any State, county, district or other public hospital may purchase and provide the necessary facilities and equipment to establish and maintain an eye bank for restoration-of-sight purposes.
SECTION 44-7-20. Disturbing patients with radios or musical instruments.
It shall be unlawful for any person to operate any radio or other musical instrument in such a manner that it annoys or disturbs any patient confined to a hospital or sanitarium. Any person violating the provisions of this section shall be guilty of a misdemeanor and, upon conviction thereof, shall be subject to a fine of not more than one hundred dollars or imprisonment of not more than thirty days.
(1) At any hospital order and receive or cause to be furnished any food or accommodation based upon contract with intent to defraud the owner or proprietor of such hospital out of the value or price of such food or accommodation contract;
(2) Obtain credit at any hospital by the use of any false pretense or device or by fraudulently depositing at such hospital any baggage or property of less value than the amount of such credit or of the bill by such person incurred, unless credit be given by express agreement; or
(3) After obtaining creditor accommodation based upon contract at any hospital, surreptitiously remove his baggage or property therefrom;
Shall be guilty of a misdemeanor. Proof (a) that lodging, food or other accommodation based upon contract was obtained by false pretense or by false or fictitious show or pretense of baggage, (b) that a person absconded without paying or offering to pay for such food, lodging or other accommodation based upon contract or (c) that a person surreptitiously removed or attempted to remove his baggage shall be prima facie proof of the fraudulent intent mentioned in this section. Any person convicted of violating the provisions of this section shall pay a fine of not more than fifty dollars or be imprisoned for not more than thirty days, in the discretion of the magistrate.
The provisions of this section shall not include the fees of physicians and surgeons.
SECTION 44-7-40. Conveyance to Federal Government of lands for veterans' hospital.
The governing body of any county in this State in which the United States Government decides to locate or build a hospital for veterans may, by resolution passed by a majority vote of such body, convey to the United States Government in fee simple, free of all encumbrances, any lands now owned or hereafter acquired by it for the use and benefit of such veterans' hospital, such conveyance to be without consideration and as a gift to the United States Government. Such deed of conveyance if made under the provisions of this section shall be signed by such officer or officers of the county as the resolution duly passed by such governing body may prescribe or provide. A certified copy of such resolution shall be recorded with the deed of conveyance so made.
SECTION 44-7-50. Modification of doctrines of charitable and sovereign immunity as they relate to hospitals and other medical facilities.
The doctrines of charitable and sovereign immunity as they relate to hospitals and other medical facilities in this State are hereby modified to the extent that any person sustaining an injury or dying by reason of the tortious act of commission or omission of agents, servants, employees or officers of a charitable hospital or medical facility or of a hospital or other medical facility operated or funded by the State, its agencies, departments, institutions, commissions, boards or political subdivisions may recover in any action brought against such hospital or other medical facility for such actual damages as he may sustain a sum not exceeding one hundred thousand dollars. Except as to licensed physicians and dentists, the judgment in an action under this section shall constitute a complete bar to any action by the claimant, by reason of the same subject matter, against the employee of the charitable or governmental entity whose act or omission gave rise to the claim; and a plaintiff, when bringing an action under the provisions of this section, shall only name as a party defendant the entity for which the employee was acting and shall not name the employee individually unless the entity for which the employee was acting cannot be determined at the time the action is instituted. In the event the employee is individually named under the conditions permitted above, the entity for which the employee was acting shall be substituted as the party defendant when it can be so reasonably determined. The provisions of this section shall in no way limit or modify the liability of a licensed physician or dentist.
SECTION 44-7-60. Borrowing money by nonprofit public hospitals.
Notwithstanding any other provision of law, the governing board of any nonprofit public hospital in this State with the approval of the governing body of the county wherein such hospital is located which has borrowed money may continue to borrow money in the name of the hospital for general hospital purposes. "Borrowing money" as used herein shall include the authority to make notes or other evidences of debt and to secure payment thereof by placing a mortgage on any or all of its property, both real and personal.
SECTION 44-7-70. Report to State Board of Medical Examiners concerning action resulting in limitation upon physician's privilege to practice in health care facility.
(A) The medical staff chief or medical director of a health care facility, as defined in Section 44-7-130, shall report in writing to the State Board of Medical Examiners the results of and the circumstances concerning an action resulting in the revocation or suspension of or other limitation upon, a physician's privileges to practice in that health care facility. This report is not required in the case of:
(1) a nondisciplinary resignation by the physician; however, a resignation occurring after an incident or occurrence which could result in the revocation or suspension of or other limitation upon the physician's privileges must be reported;
(2) a minor disciplinary action regarding the physician's privileges in that health care facility when the action taken does not involve the revocation or suspension of or other limitation upon the physician's privileges to practice there;
(3) a disciplinary action resulting from the physician's failure to meet recordkeeping standards;
(4) a disciplinary action resulting from the physician's failure to attend meetings; or
(5) other disciplinary actions as defined by regulation promulgated by the State Board of Medical Examiners.
(B) The medical staff chief or medical director of a health care facility, as defined in Section 44-7-130, shall report in writing to the State Board of Medical Examiners and to the Board of Podiatry Examiners the results of and the circumstances concerning an action resulting in the revocation or suspension of or other limitation upon, a podiatrist's privileges to practice in that health care facility. This report is not required in the case of:
(1) a nondisciplinary resignation by the podiatrist; however, a resignation occurring after an incident or occurrence which could result in the revocation or suspension of or other limitation upon the podiatrist's privileges must be reported;
(2) a minor disciplinary action regarding the podiatrist's privileges in that health care facility when the action taken does not involve the revocation or suspension of or other limitation upon the podiatrist's privileges to practice there;
(3) a disciplinary action resulting from the podiatrist's failure to meet recordkeeping standards;
(4) a disciplinary action resulting from the podiatrist's failure to attend meetings; or
(5) other disciplinary actions as defined by regulation promulgated by the Board of Podiatry Examiners.
(C) A person making a report required by this section is immune from criminal and civil liability in making the report, if the report is made in good faith and without malice.
SECTION 44-7-77. Program to obtain voluntary acknowledgment of paternity of newborns.
The Department of Health and Environmental Control and the State Department of Social Services, in conjunction with the South Carolina Hospital Association, shall develop and implement a program to promote obtaining voluntary acknowledgments of paternity as soon after birth as possible and where possible before the release of the newborn from the hospital. A voluntary acknowledgment including those obtained through an in-hospital program shall contain the requirements of Section 20-7-956(A)(4) and the social security number, or the alien identification number assigned to a resident alien who does not have a social security number, of both parents, and must be signed by both parents. The signatures must be notarized. As part of its in-hospital voluntary acknowledgment of paternity program, a birthing hospital as part of the birth registration process, shall collect, where ascertainable, information which is or may be necessary for the establishment of the paternity of the child and for the establishment of child support. The information to be collected on the father or on the putative father if paternity has not been established includes, but is not limited to, the name of the father, his date of birth, home address, social security number, or the alien identification number assigned to a resident alien who does not have a social security number, and employer's name, and additionally for the putative father, the names and addresses of the putative father's parents.
SECTION 44-7-78. Authority to establish facilities, programs and services in other locations.
Notwithstanding any other provision of law, an entity that operates a health care facility as defined in Section 44-7-130(10) may develop and operate facilities, programs, and services in any location where such facilities, programs, or services support the entity or provide services to residents in the area, provided all other statutory and regulatory requirements are met, including the State Certification of Need and Health Facility Licensure Act, Article 3, Chapter 7, Title 44 and related regulations promulgated by the department.
(1) "Nursing home" means a facility with an organized nursing staff to maintain and operate organized facilities and services to accommodate two or more unrelated persons over a period exceeding twenty-four hours, which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing intermediate or skilled nursing care for persons who are not in need of hospital care.
(2) "Medicaid nursing home permit" means a permit to serve Medicaid patients in an appropriately certified nursing home.
(3) "Medicaid patient" means a person who is eligible for Medicaid (Title XIX) sponsored long-term care services.
(4) "Medicaid patient day" means a day of nursing home care for which a nursing home receives Medicaid reimbursement.
(5) "Department" means the Department of Health and Environmental Control.
No nursing home may provide care to Medicaid patients without first obtaining a permit in the manner provided in this article.
SECTION 44-7-84. Determination and allocation of Medicaid nursing home patient days; application for permit; rules and regulations.
(A) In the annual appropriations act, the General Assembly shall establish the maximum number of Medicaid patient days for which the department is authorized to issue Medicaid nursing home permits. The State Department of Health and Human Services shall provide the number of Medicaid patient days available to the department within thirty days after the effective date of the annual appropriations act.
(B) Based on a method the department develops for determining the need for nursing home care for Medicaid patients in each area of the State, the department shall determine the distribution of Medicaid patient days for which Medicaid nursing home permits can be issued. Nursing homes holding a Medicaid nursing home permit must be allocated Medicaid days based on their current allocation and available funds. Requests for days must be submitted to the department no later than June fifteenth each year. The application must state the specific number of Medicaid patient days the nursing home will provide. If a nursing home requests fewer days than the previous year, those days first must be offered to the facilities within the same county currently holding a Medicaid nursing home permit. However, if Medicaid patient days remain available after being offered to those nursing homes currently holding a Medicaid patient days permit in that county, then existing nursing homes with a restricted Certificate of Need, within the same county, may apply for a Medicaid nursing home permit to receive the Medicaid patient days remaining available. Following the initial allocation of Medicaid patient days, any additional Medicaid patient days available must be credited to a statewide pool and must be available based on the percent of need indicated by the Community Long Term Care waiting list. If a nursing home has provided fewer Medicaid patient days than allowable under the Medicaid nursing home permit program, the department may issue a Medicaid nursing home permit for fewer days than requested in order to ensure that the nursing home will serve the minimum number of Medicaid patients. If a nursing home has its Medicaid patient days reduced, the freed days first must be offered to other facilities in the same county before being offered to other nursing homes in the State. In addition, a nursing home that fails to provide at least ten percent fewer days than the number stated in its permit is not eligible to receive additional Medicaid patient days the next year. The department shall analyze the performance of nursing homes that are under the permit minimum for a fiscal year, including utilization data from the State Department of Health and Human Services, anticipated back days, delayed payments, CLTC waiting list, and other factors considered significant by the department. Based on this analysis, if the department determines that the nursing home remains out of compliance, the nursing home must be fined by the same percentages as provided for in Section 44-7-90 and is subject to having its Medicaid patient days reduced. A nursing home which terminates its Medicaid contract must not be penalized for not meeting the requirements of this section if the nursing home was in compliance with its permit at the time of the cancellation. However, if the maximum number of Medicaid patient days authorized by the General Assembly is decreased, the nursing home may be required to absorb a proportionate decrease in its Medicaid patient days' allocation.
SECTION 44-7-88. Involuntary discharge or transfer of Medicaid nursing home patients prohibited; request for waiver of permit requirements.
Nursing home patients may not be involuntarily discharged or transferred due to their Medicaid status. If no Medicaid patients are waiting for admission to the nursing home, or if for some other reason a nursing home anticipates the possibility that the home cannot satisfy the Medicaid nursing home permit requirements, the home may request a waiver of the permit requirements from the department.
SECTION 44-7-90. Violations of Sections 44-7-80 through 44-7-90; penalties.
(A) Based on reports from the State Department of Health and Human Services, the department shall determine each nursing home's compliance with its Medicaid nursing home permit. Violations of this article include:
(1) a nursing home exceeding by more than ten percent the number of Medicaid patient days stated in its permit;
(2) a nursing home failing to provide at least ten percent fewer days than the number stated in its permit;
(3) the provisions of any Medicaid patient days by a home without a Medicaid nursing home permit.
(B) Each Medicaid patient day above or below the allowable range is considered a separate violation. Fines for nursing homes out of compliance with their Medicaid Nursing Home Permit for years before July 1, 1995 are waived. After June 30, 1995, a nursing home that exceeds by more than ten percent the number of Medicaid patient days stated in its permit must be fined based on the number of Medicaid patient days exceeding the permit days times their daily Medicaid per diem times thirty percent. A nursing home that fails to provide at least ten percent fewer days than the number stated in its permit must be fined based on the number of Medicaid patient days under the permit days times their daily Medicaid per diem times thirty percent. A fine assessed against a nursing home must be deducted from the nursing home's Medicaid reimbursement. Appeals from this action must comply with the appropriate provisions of Chapter 23 of Title 1.
ARTICLE 3.
STATE CERTIFICATION OF NEED AND HEALTH FACILITY LICENSURE ACT
The purpose of this article is to promote cost containment, prevent unnecessary duplication of health care facilities and services, guide the establishment of health facilities and services which will best serve public needs, and ensure that high quality services are provided in health facilities in this State. To achieve these purposes, this article requires:
(1) the issuance of a Certificate of Need before undertaking a project prescribed by this article;
(2) adoption of procedures and criteria for submittal of an application and appropriate review before issuance of a Certificate of Need;
(3) preparation and publication of a State Health Plan;
(4) the licensure of facilities rendering medical, nursing, and other health care.
(1) "Affected person" means the applicant, a person residing within the geographic area served or to be served by the applicant, persons located in the health service area in which the project is to be located and who provide similar services to the proposed project, persons who before receipt by the department of the proposal being reviewed have formally indicated an intention to provide similar services in the future, persons who pay for health services in the health service area in which the project is to be located and who have notified the department of their interest in Certificate of Need applications, the State Consumer Advocate, and the State Ombudsman. Persons from another state who would otherwise be considered "affected persons" are not included unless that state provides for similar involvement of persons from South Carolina in its certificate of need process.
(2) "Ambulatory surgical facility" means a facility organized and administered for the purpose of performing surgical procedures for which patients are scheduled to arrive, receive surgery, and be discharged on the same day. The owner or operator makes the facility available to other providers who comprise an organized professional staff.
(3) "Board" means the State Board of Health and Environmental Control.
(4) "Chiropractic inpatient facility" means a facility organized and administered to provide overnight care for patients requiring chiropractic services, including vertebral sublaxation, analysis, and adjustment.
(5) "Competing applicants" means two or more persons or health care facilities as defined in this article who apply for Certificates of Need to provide similar services or facilities in the same service area within a time frame as established by departmental regulations and whose applications, if approved, would exceed the need for services or facilities.
(6) "Community residential care facility" means a facility which offers room and board and provides a degree of personal assistance for two or more persons eighteen years old or older.
(7) "Day-care facility for adults" means a facility for adults eighteen years or older which offers in a group setting a program of individual and group activities and therapies. The program is directed toward providing community-based care for those in need of a supportive setting for less than twenty-four hours a day, thereby preventing unnecessary institutionalization, and shall provide a minimum of four and a maximum of fourteen hours of operation a day.
(8) "Department" means the Department of Health and Environmental Control.
(9) "The federal act" means Title VI of the United States Public Health Service Act (the Hill-Burton Construction Program); Title XVI of the United States Public Health Service Act (National Health Planning and Resources Development Act of 1974--Public Law 93-641); grants for all center and facility construction under Public Law 91-211 (community mental health centers' amendments to Title II, Public Law 88-164, Community Mental Health Centers Act); grants for all facility construction under Public Law 91-517 (developmental disabilities services and facilities construction amendments of 1970 to Part C, Title I, grants for construction of facilities for the mentally retarded--Public Law 88-164); and other federal programs as may exist or be enacted which provide for the construction of hospitals or related health facilities.
(10) "Health care facility" means acute care hospitals, psychiatric hospitals, alcohol and substance abuse hospitals, methadone treatment facilities, tuberculosis hospitals, nursing homes, ambulatory surgical facilities, hospice facilities, radiation therapy facilities, rehabilitation facilities, residential treatment facilities for children and adolescents, habilitation centers for mentally retarded persons or persons with related conditions, and any other facility for which Certificate of Need review is required by federal law.
(11) "Health service" means clinically related, diagnostic, treatment, or rehabilitative services and includes alcohol, drug abuse, and mental health services for which specific standards or criteria are prescribed in the State Health Plan.
(12) "Hospital" means a facility organized and administered to provide overnight medical or surgical care or nursing care of illness, injury, or infirmity and may provide obstetrical care, and in which all diagnoses, treatment, or care is administered by or under the direction of persons currently licensed to practice medicine, surgery, or osteopathy.
Hospital may include residential treatment facilities for children and adolescents in need of mental health treatment which are physically a part of a licensed psychiatric hospital. This definition does not include facilities which are licensed by the Department of Social Services.
(13) "Nursing home" means a facility with an organized nursing staff to maintain and operate organized facilities and services to accommodate two or more unrelated persons over a period exceeding twenty-four hours which is operated either in connection with a hospital or as a freestanding facility for the express or implied purpose of providing intermediate or skilled nursing care for persons who are not in need of hospital care.
(14) "Facility for chemically dependent or addicted persons" means a facility organized to provide outpatient or residential services to chemically dependent or addicted persons and their families based on an individual treatment plan including diagnostic treatment, individual and group counseling, family therapy, vocational and educational development counseling, and referral services.
(15) "Person" means an individual, a trust or estate, a partnership, a corporation including an association, joint stock company, insurance company, and a health maintenance organization, a state, a political subdivision, or an instrumentality including a municipal corporation of a state, or any legal entity recognized by the State.
(16) "Residential treatment facility for children and adolescents" means a facility operated for the assessment, diagnosis, treatment, and care by two or more persons of 'children and adolescents in need of mental health treatment' which provides:
(a) a special education program with a minimum program defined by the South Carolina Department of Education;
(b) recreational facilities with an organized youth development program; and
(c) residential treatment for a child or adolescent in need of mental health treatment.
(17) "Solely for research" means a service, procedure, or equipment which has not been approved by the Food and Drug Administration (FDA) but which is currently undergoing review by the FDA as an investigational device. FDA research protocol and any applicable Investigational Device Exemption (IDE) policies and regulations must be followed by a facility proposing a project "solely for research".
(18) "Children and adolescents in need of mental health treatment" in a residential treatment facility means a child or adolescent under age eighteen or a child or adolescent under age twenty-one who is a client of, committed to the custody of, or in the legal custody of an agency of the State of South Carolina who manifests a substantial disorder of cognitive or emotional process, which lessens or impairs to a marked degree that child's or adolescent's capacity either to develop or to exercise age-appropriate or age-adequate behavior. The behavior includes, but is not limited to, marked disorders of mood or thought processes, severe difficulties with self-control and judgment including behavior dangerous to self or others, and serious disturbances in the ability to care for and relate to others.
(19) "Intermediate care facility for the mentally retarded" means a facility that serves four or more mentally retarded persons or persons with related conditions and provides health or rehabilitative services on a regular basis to individuals whose mental and physical conditions require services including room, board, and active treatment for their mental retardation or related conditions.
(20) "Freestanding or mobile technology" means medical equipment owned or operated by a person other than a health care facility for which the total cost is in excess of that prescribed by regulation and for which specific standards or criteria are prescribed in the State Health Plan.
(21) "Like equipment with similar capabilities" means medical equipment which does not increase the potential volume or type of procedures possible.
(22) "Facilities wherein abortions are performed" means a facility, other than a hospital, in which any second trimester or five or more first trimester abortions are performed in a month.
(23) "Radiation therapy facility" means a person or a health care facility which provides or seeks to provide mega-voltage therapeutic services to patients through the use of high energy radiation.
SECTION 44-7-140. Department as sole agency for control of program.
The department is designated the sole state agency for control and administration of the granting of Certificates of Need and licensure of health facilities and other activities necessary to be carried out under this article.
In carrying out the purposes of this article, the department shall:
(1) require reports and make inspections and investigations as considered necessary;
(2) to the extent that is necessary to effectuate the purposes of this article, enter into agreements with other departments, commissions, agencies, and institutions, public or private;
(3) adopt in accordance with Article I of the Administrative Procedures Act substantive and procedural regulations considered necessary by the department and approved by the board to carry out the department's licensure and Certificate of Need duties under this article, including regulations to deal with competing applications;
(4) accept on behalf of the State and deposit with the State Treasurer, any grant, gift, or contribution made to assist in meeting the cost of carrying out the purpose of this article and expend it for that purpose;
(5) The department may adopt a filing fee for Certificate of Need applications. The fee must be approved by the board. Any fee collected pursuant to this section must be deposited into the general fund of the State. The fee must be collected prior to review of the application. A fee may not be increased beyond the cost of administration of the Certificate of Need Program.
SECTION 44-7-160. Certificate of Need required under certain circumstances.
A person or health care facility as defined in this article is required to obtain a Certificate of Need from the department before undertaking any of the following:
(1) the construction or other establishment of a new health care facility;
(2) a change in the existing bed complement of a health care facility through the addition of one or more beds or change in the classification of licensure of one or more beds;
(3) an expenditure by or on behalf of a health care facility in excess of an amount to be prescribed by regulation which, under generally acceptable accounting principles consistently applied, is considered a capital expenditure except those expenditures exempted in Section 44-7-170(B)(1). The cost of any studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the development, acquisition, improvement, expansion, or replacement of any plant or equipment must be included in determining if the expenditure exceeds the prescribed amount;
(4) a capital expenditure by or on behalf of a health care facility which is associated with the addition or substantial expansion of a health service for which specific standards or criteria are prescribed in the State Health Plan;
(5) the offering of a health service by or on behalf of a health care facility which has not been offered by the facility in the preceding twelve months and which has an annual operating cost in excess of an amount to be prescribed by regulation and for which specific standards or criteria are prescribed in the State Health Plan;
(6) the acquisition of medical equipment which is to be used for diagnosis or treatment if the total project cost is in excess of that prescribed by regulation;
(7) the acquisition or change in ownership or in controlling interest of a health care facility or entity owning a health care facility directly or indirectly by purchase, lease, gift, donation, sale of stock, or comparable arrangement if the acquisition or change in ownership or controlling interest may result in an increase in cost to the facility or increase in government-sponsored reimbursement;
(8) the acquisition of an existing health care facility by a person who has failed to notify the department and seeks an exemption before entering into a contractual arrangement to acquire an existing facility;
(9) an expenditure or financial obligation made in preparation for the offering or developing of a project which requires certification of need pursuant to this section if the expenditure or financial obligation is in excess of an amount to be prescribed by regulation.
SECTION 44-7-170. Institutions and transactions exempt from article.
(A) The provisions of this article do not apply to:
(1) health care facilities owned and operated by the federal government;
(2) the offices of a licensed private practitioner whether for individual or group practice except as provided for in Section 44-7-160(1) and (6);
(3) the acquisition by a health care facility of medical equipment to be used solely for research, the offering of an institutional health service by a health care facility solely for research, or the obligation of a capital expenditure by a health care facility to be made solely for research if it does not (a) affect the charges of the facility for the provision of medical or other patient care services other than the services which are included in the research; (b) change the bed capacity of the facility; or (c) substantially change the medical or other patient care services of the facility. A written description of the proposed research project must be submitted to the department in order for the department to determine if the above conditions are met. A Certificate of Need is required in order to continue use of the equipment or service after research restrictions are removed;
(4) purchases of or agreements to purchase real estate; however, the costs associated with the purchase of real estate must be included in determining the total project cost at the time the real estate is proposed to be developed.
(B) The Certificate of Need provisions of this article do not apply to:
(1) an expenditure by or on behalf of a health care facility for nonmedical projects for services such as refinancing existing debt, parking garages, laundries, roof replacements, computer systems, telephone systems, heating and air conditioning systems, upgrading facilities which do not involve additional square feet or additional health services, replacement of like equipment with similar capabilities, or similar projects as described in regulations;
(2) facilities owned and operated by the State Department of Mental Health and the South Carolina Department of Mental Retardation, except an addition of one or more beds to the total number of beds of the departments' health care facilities existing on July 1, 1988;
(3) educational and penal institutions maintaining infirmaries for the exclusive use of student bodies and inmate populations;
(4) any federal health care facility sponsored and operated by this State;
(5) community-based housing designed to promote independent living for persons with mental or physical disabilities. This does not include a facility defined in this article as a "health care facility".
(6) kidney disease treatment centers including, but not limited to, free standing hemodialysis centers and renal dialysis centers.
SECTION 44-7-180. Health planning committee; appointment, composition, terms, and allowances; State Health Plan; fees to cover costs of certificate of need program.
(A) There is created a health planning committee comprised of fourteen members. The Governor shall appoint twelve members, at least one member from each congressional district. Each of the following groups must be equally represented among the Governor's appointees: health care consumers, health care financiers to include business and insurance, and health care providers. The chairman of the board shall appoint one member. The South Carolina Consumer Advocate or the Consumer Advocate's designee is an ex officio nonvoting member. Members are appointed for four-year terms, may serve only two consecutive terms, and are allowed the usual mileage and subsistence as provided for members of boards, committees, and commissions.
(B) With the advice of the health planning committee, the department shall prepare a State Health Plan for use in the administration of the Certificate of Need Program provided in this article. The plan at a minimum must include:
(1) an inventory of existing health care facilities, beds, specified health services, and equipment;
(2) projections of need for additional health care facilities, beds, health services, and equipment;
(3) standards for distribution of health care facilities, beds, specified health services, and equipment including scope of services to be provided, utilization, and occupancy rates, travel time, regionalization, other factors relating to proper placement of services, and proper planning of health care facilities; and
(4) a general statement as to the project review criteria considered most important in evaluating certificate of need applications for each type of facility, service, and equipment, including a finding as to whether the benefits of improved accessibility to each such type of facility, service, and equipment may outweigh the adverse affects caused by the duplication of any existing facility, service, or equipment.
The State Health Plan must address and include projections and standards for specified health services and equipment which have a potential to substantially impact health care cost and accessibility. Nothing in this provision shall be construed as requiring the department to approve any project which is inconsistent with the State Health Plan.
(C) Upon approval by the health planning committee, the State Health Plan must be submitted at least once every two years to the board for final revision and adoption. Once adopted by the board, the plan may later be revised through the same planning and approval process. The department shall adopt by regulation a procedure to allow public review and comment, including regional public hearings, before adoption or revision of the plan.
(D) The Department of Health and Environmental Control may charge and collect fees to cover the cost of operating the Certificate of Need program. Upon submission of a complete Certificate of Need application, the applicant must pay a fee of five hundred dollars plus five-tenths of one percent of the project cost for review of the project, not to exceed seven thousand, five hundred dollars; however, for an applicant whose review fee would exceed seven thousand, five hundred dollars an additional fee of seven thousand, five hundred dollars is imposed if the applicant is awarded a Certificate of Need, which must be paid at the time of the award. Fees paid pursuant to this subsection must be deposited to the credit of the general fund of the State.
SECTION 44-7-185. Establishment of a task force; conducting a study regarding open-heart surgery and therapeutic cardiac catheterization.
A. There is established a task force under the Health Care Planning and Oversight Committee which shall conduct a study regarding open-heart surgery and therapeutic cardiac catheterization services for residents of South Carolina counties that are included in the Federal Bureau of Census' Metropolitan Statistical Areas (MSA) of another state. The study shall consider access to open-heart surgery to citizens of this State, the total cost of care to the patient and the patient's family, the impact on the economy of South Carolina, the impact on health care economics of South Carolina; quality of care available based upon physician volume, population trends, and projections of the South Carolina community.
The task force must be appointed by the Governor and must be composed of:
(1) one South Carolina citizen residing in an MSA to be studied;
(2) one member of the General Assembly representing an MSA to be studied;
(3) the Chairman of the State Health Planning Committee;
(4) a physician recommended by the South Carolina Medical Association;
(5) a representative of the hospital industry recommended by the South Carolina Hospital Association;
(6) the Commissioner of the South Carolina Department of Health and Environmental Control; and
(7) the Director of the Department of Insurance.
Members of the task force shall receive the mileage, subsistence, and per diem allowed by law for members of state boards, committees, and commissions. The findings and recommendations of the task force must be submitted to the Health Care Planning and Oversight Committee and the state health planning committee, established pursuant to Section 44-7-180, no later than January 1, 1995. In the manner provided for in Section 44-7-180 of the 1976 Code, the findings and recommendations submitted to the health planning committee become part of the State Health Plan in effect at the time the findings and recommendations are submitted to the committee.
B. Until the task force established under subsection A. issues its findings and recommendations, a facility may provide therapeutic cardiac catheterizations if that facility:
(1) has obtained a Certificate of Need for diagnostic cardiac catheterization before July 10, 1992, and filed to obtain a Certificate of Need for open-heart surgical services before January 1, 1993; and
(2) has a written open-heart surgery back-up agreement with a facility that provides an open-heart surgery service located within a thirty-minute one-way drive.
If the findings and recommendations of the task force do not provide for continued performance of therapeutic cardiac catheterization at a facility performing these services under this provision, the facility shall cease performing therapeutic cardiac catheterizations services within thirty days of the issuance of the findings and recommendations. If the findings and recommendations of the task force provide for continued performance of cardiac catheterizations at a facility performing this service under this provision and the facility applies for a Certificate of Need within thirty days, the facility may continue to provide the services until a final agency decision on the application for a Certificate of Need is issued, unless continued service is otherwise prohibited by Section 44-7-180 of the 1976 Code.
C. A committee appointed by the South Carolina Board of Medical Examiners shall conduct an annual review of the provision of therapeutic cardiac catheterization services and related physician practice at any hospital providing these services as authorized under subsection B. The committee must be composed of one physician specializing in cardiology from each congressional district and one cardiologist selected by the Board of Medical Examiners from the Medical University of South Carolina Cardiology Department who shall serve as chairman of the committee. None of the members of the committee may practice or reside in the Metropolitan Statistical Area (MSA) in which a facility to be reviewed is located. If the committee finds action by any physician at a facility where a review is being conducted creates an unreasonable risk to any patient, the State Board of Medical Examiners may take such action against the physician it considers necessary. In addition, the committee shall forward its findings to the Department of Health and Environmental Control and the department may take such action against the facility it considers necessary.
D. On May 25, 1994, the Office of Research and Statistical Services of the State Budget and Control Board immediately shall initiate a study of facilities providing therapeutic cardiac catheterizations without on-site open-heart surgery services. The study shall compare patient outcomes between these facilities and facilities with on-site open-heart surgery and determine if there is a statistically significant difference in patient outcomes. If the study concludes that patients of a facility conducting therapeutic cardiac catheterization without on-site open-heart surgery services have a statistically significant unfavorable outcome compared to patients at facilities with open-heart surgery services, the facility without open-heart surgery services immediately shall discontinue performing therapeutic cardiac catheterizations. The Office of Research and Statistical Services shall issue its findings no later than twelve months from May 25, 1994. Any facility which is the subject of this study shall provide the office with all data and information sufficient to complete its work.
E. If the department has reason to believe that patient care is being compromised, it may impose sanctions and take action authorized under Article 3, Chapter 7, Title 44 of the 1976 Code.
F. All proceedings of a person or entity conducting a review described in subsections C. or D. are not subject to discovery, subpoena or introduction into evidence in any civil action for damages for injury to the person arising out of any medical or surgical treatment, omission, or operation by a licensed health care provider as defined in Article 5, Chapter 79, Title 38. Further, there is no monetary liability on the part of and no cause of action for damages arising against a person or entity conducting or participating in a review described in subsection C. Nothing in Article 3, Chapter 7, Title 44 of the 1976 Code is intended to provide immunity to a person or entity in a civil action for damages.
G. Nothing in this section negates or may be construed to prohibit any enforcement action taken by the department against a facility for initiating a therapeutic cardiac service without a Certificate of Need.
H. Except as otherwise provided for in this section, the provisions of this section apply prospectively only.
The department shall adopt, upon approval of the board, Project Review Criteria which, at a minimum, must provide for the determination of need for health care facilities, beds, services and equipment, to include demographic needs, appropriate distribution, and utilization; accessibility to underserved groups; availability of facilities and services without regard to ability to pay; absence of less costly and more effective alternatives; appropriate financial considerations to include method of financing, financial feasibility, and cost containment; consideration of impact on health systems resources; site and building suitability; consideration of quality of care; and relevant special considerations as may be appropriate. The Project Review Criteria must be adopted as a regulation pursuant to the Administrative Procedures Act.
SECTION 44-7-200. Application for Certificate of Need.
(A) An application for a Certificate of Need must be submitted to the department in a form established by regulation. The application must address all applicable standards and requirements set forth in departmental regulations, Project Review Criteria of the department, and the State Health Plan. The application must include the payment of a nonrefundable initial application fee of five hundred dollars. The department shall deduct this fee from the Certificate of Need filing fee which is payable in accordance with departmental regulations when the application is determined to be complete.
(B) Within twenty days before submission of an application, the applicant shall publish notification that an application is to be submitted to the department in a newspaper serving the area where the project is to be located for three consecutive days. The notification must contain a brief description of the scope and nature of the project. No application may be accepted for filing by the department unless accompanied by proof that publication has been made for three consecutive days within the prior twenty-day period and payment of the initial application fee has been received.
(C) Upon publication of this notice and until a contested case hearing is requested pursuant to Section 44-7-210:
(1) members of the board and persons appointed by the board to hear appeals from department staff decisions may not communicate directly or indirectly with any person in connection with the application; and
(2) no person shall communicate, or cause another to communicate, as to the merits of the application with members of the board and persons appointed by the board to hear appeals from department staff decisions.
A person who violates this subsection is subject to the penalties provided in Section 1-23-360.
(D) After receipt of an application with proof of publication and payment of the initial application fee, the department shall publish in the State Register a notice that an application has been accepted for filing. Within thirty days of acceptance of the application, the department may request additional information as may be necessary to complete the application. The applicant has thirty days from the date of the request to submit the additional information. If the applicant fails to submit the requested information within the thirty-day period, the application is considered withdrawn.
SECTION 44-7-210. Notification that application for Certificate of Need has been completed; review process; proposal to grant or deny certificate; final decision; methadone treatment facilities.
(A) After the department has determined that an application is complete, affected persons must be notified in accordance with departmental regulations. The notification of affected persons begins the review period. During the review process, the department shall determine the relative importance of the project review criteria for this project and shall notify the applicant of this determination. The applicant has thirty days from the date of the receipt of this notice to submit any additional information. The review period for a completed application is sixty days from the date of notification of affected persons, or up to sixty days from the date that applicants are notified of the relative importance of project review criteria provided for in this section, whichever is longer. One extension of up to sixty days may be granted by the department in accordance with departmental regulations with the exception of an extension that is granted to comply with a request for a public hearing.
(B) The department may hold a public hearing, if timely requested, to gather information and obtain public comment and opinion about the proposed project.
(C) The department may not issue a Certificate of Need unless an application complies with the State Health Plan, Project Review Criteria, and other regulations. Based on project review criteria and other regulations, which must be identified by the department, the department may refuse to issue a Certificate of Need even if an application complies with the State Health Plan. In the case of competing applications, the department shall award a Certificate of Need, if appropriate, on the basis of which, if any, most fully complies with the requirements, goals, and purposes of this article and the State Health Plan, Project Review Criteria, and the regulations adopted by the department.
(D) On the basis of staff review of the application, the staff of the department shall make a proposed decision to grant or deny the Certificate of Need. Notice of the proposed decision must be sent to the applicant and affected persons who have asked to be notified. The proposed decision becomes the final agency decision within ten days after the receipt of a notice of the proposed decision by the applicant unless:
(1) a reconsideration by the staff of the department is requested in writing within the ten-day period by an affected person showing good cause for reconsideration of the proposed decision; or
(2) a contested case hearing before the board, or its designee, regarding the grant or denial of the Certificate of Need is requested in writing within the ten-day period by the applicant or other affected person with standing to contest the grant or denial of the application.
Reconsideration by the staff must occur within thirty days from receipt of the request.
(E) The department's proposed decision is not final until the completion of reconsideration or contested case proceedings. The burden of proof in a reconsideration or contested case hearing must be upon the moving party. The contested case hearing before the board or its designee is conducted as a contested case under the Administrative Procedures Act. The issues considered at the contested case hearing are limited to those presented or considered during the staff review and decision process.
(F) The department may not issue a Certificate of Need approval for a methadone treatment facility until licensure standards are promulgated by the department, in accordance with the Administrative Procedures Act, for these facilities. The department shall convene a study group to revise and propose licensure standards for methadone clinics. The study group shall consist of representatives of the department, the Department of Alcohol and Other Drug Abuse Services, methadone providers in South Carolina, and the Medical University of South Carolina. The licensure standards shall include standards for location of these facilities within the community. Methadone treatment facilities licensed as of January 1, 1997, must not be required to obtain a Certificate of Need pursuant to this section.
SECTION 44-7-220. Judicial review of final board decision.
After the contested case hearing is concluded and a final board decision is made, a party who participated in the contested case hearing and who is affected adversely by the board's decision may obtain judicial review of the decision in the circuit court pursuant to the Administrative Procedures Act. An appeal taken to the circuit court from a decision of the board on a Certificate of Need application has precedence on the court's calendar and must be heard not later than forty-five days from the date the petition is filed.
An applicant whose Certificate of Need application is denied by the board in favor of a competing application or a party adversely affected by the board's decision shall deposit a bond with the clerk of court for the circuit court before the filing of a petition to appeal a final decision of the board granting or denying a Certificate of Need. The bond must be secured by cash or a surety authorized to do business in this State in an amount equal to five percent of the total cost of the project or twenty thousand dollars, whichever is greater. If the court affirms the decision of the board or dismisses the appeal, the court may award to the applicant approved for the Certificate of Need who is a party to the appeal all or a portion of the bond and may award reasonable attorney's fees and costs incurred in the appeal. If an applicant appeals only the denial of his Certificate of Need application and there is no competing application involved in the appeal, the applicant is not required to deposit a bond with the circuit court.
If, at any stage of the appeal process involving the grant or denial of a Certificate of Need, the court finds that the appeal was frivolous, the court may award damages to the applicant approved for the Certificate of Need in addition to awarding the approved applicant single or double costs incurred in the appeal. In the case of a frivolous appeal of a denial of a Certificate of Need which does not involve a competing application, the court may award costs incurred in the appeal to the department.
As used in this section, "frivolous appeal" means any one of the following:
(1) an appeal taken solely for purposes of delay or harassment;
(2) where no question of law is involved;
(3) where the appeal is without merit.
SECTION 44-7-230. Limitation on Certificate of Need; capital expenditure; architectural plans; time limitation; Certificate of Need as not transferable.
(A) The Certificate of Need, if issued, is valid only for the project described in the application including location, beds and services to be offered, physical plant, capital or operating costs, or other factors as set forth in the application, except as may be modified in accordance with regulations. The department shall require periodic reports and make inspections to determine compliance with the Certificate of Need. Implementation of the project or operation of the facility or medical equipment that is not in accordance with the Certificate of Need application or conditions subsequently agreed to by the applicant and the department may be considered a violation of this article.
(B) In issuing a Certificate of Need, the department shall specify the maximum capital expenditure obligated under the certificate. The department shall prescribe the method used to determine capital expenditure maximums, establish procedures to monitor capital expenditures obligated under certificates, and establish procedures to review projects for which the capital expenditure maximum is exceeded or expected to be exceeded.
(C) Prior to any construction authorized by a Certificate of Need, final drawings and specifications prepared by an architect or engineer legally registered under the laws of this State must be submitted to the department for approval. All construction must be completed in accordance with approved plans and specifications and prior approval must be obtained from the department for any changes that substantially alter the scope of work, function of construction, or major items of equipment, safety, or cost of the facility during construction.
(D) A Certificate of Need is valid for six months from the date of issuance except for projects involving construction or replacement of, or major renovations or additions to, an acute care hospital. For these projects the Certificate of Need is valid for one year from the date of issuance. A Certificate of Need must be issued with a timetable submitted by the applicant and approved by the department to be followed for completion of the project. The holder of the Certificate of Need shall submit periodic progress reports on meeting the timetable as may be required by the department. Failure to meet the timetable results in the revocation of the Certificate of Need by the department unless the department determines that extenuating circumstances beyond the control of the holder of the Certificate of Need are the cause of the delay. The department may grant two extensions of up to six months each upon evidence that substantial progress has been made in accordance with procedures set forth in regulations. The board may grant further extensions of up to six months each only if it determines that substantial progress has been made in accordance with the procedures set forth in regulations.
(E) A Certificate of Need is nontransferable. A Certificate of Need or rights thereunder may not be sold, assigned, leased, transferred, mortgaged, pledged, or hypothecated, and any actual transfer or attempt to make a transfer of this sort results in the immediate voidance of the Certificate of Need. The sale or transfer of the controlling interest or majority ownership in a corporation, partnership, or other entity holding, either directly or indirectly, a Certificate of Need, results in the transfer and voidance of a Certificate of Need.
The department may establish a construction program providing for adequate facilities in this State and, insofar as possible, shall provide for the distribution of facilities and services throughout this State in such manner as to make all types of health services reasonably accessible to all persons in this State. The State Health Plan as required by this article may be used for purposes of establishing the relative need of projects for which applications are submitted under this construction program. Submittal of applications and review and approval of projects for which federal funds are requested must be in accordance with regulations adopted by the department and applicable federal act.
SECTION 44-7-250. Department to establish and enforce basic standards.
The department shall establish and enforce basic standards for the licensure, maintenance, and operation of health facilities and services to ensure the safe and adequate treatment of persons served in this State.
(A) If they provide care for two or more unrelated persons, the following facilities or services may not be established, operated, or maintained in this State without first obtaining a license in the manner provided by this article and regulations promulgated by the department:
(1) hospitals, including general and specialized hospitals;
(2) nursing homes;
(3) residential treatment facilities for children and adolescents;
(4) ambulatory surgical facilities;
(5) chiropractic inpatient facilities;
(6) community residential care facilities;
(7) facilities for chemically dependent or addicted persons;
(8) end-stage renal dialysis units;
(9) day-care facilities for adults;
(10) any other facility operating for the diagnosis, treatment, or care of persons suffering from illness, injury or other infirmity and for which the department has adopted standards of operation by regulation.
(11) habilitation centers for the mentally retarded or persons with related conditions.
(12) freestanding or mobile technology.
(13) facilities wherein abortions are performed.
(B) the licensing provisions of this article do not apply to:
(1) infirmaries for the exclusive use of the student bodies of privately-owned educational institutions which maintain infirmaries; or
(2) community-based housing sponsored, licensed, or certified by the South Carolina Department of Disabilities and Special Needs. The Department of Disabilities and Special Needs shall provide to the Department of Health and Environmental Control the names and locations of these facilities on a continuing basis.
(C) The department is authorized to investigate, by inspection or otherwise, any facility to determine if its operation is subject to licensure.
(D) Each hospital must have a single organized medical staff that has the overall responsibility for the quality of medical care provided to patients. Medical staff membership must be limited to doctors of medicine or osteopathy who are currently licensed to practice medicine or osteopathy by the State Board of Medical Examiners, dentists licensed to practice dentistry by the State Board of Dentistry and podiatrists licensed to practice podiatry by the State Board of Podiatry Examiners. No individual is automatically entitled to membership on the medical staff or to the exercise of any clinical privilege merely because he is licensed to practice in any state, because he is a member of any professional organization, because he is certified by any clinical examining board, or because he has clinical privileges or staff membership at another hospital without meeting the criteria for membership established by the governing body of the respective hospital. Patients of podiatrists and dentists who are members of the medical staff of a hospital must be coadmitted by a doctor of medicine or osteopathy who is a member of the medical staff of the hospital who is responsible for the general medical care of the patient. Oral surgeons who have successfully completed a postgraduate program in oral surgery accredited by a nationally recognized accredited body approved by the United States Office of Education may admit patients without the requirement of coadmission if permitted by the bylaws of the hospital and medical staff.
(E) No person, regardless of his ability to pay or county of residence, may be denied emergency care if a member of the admitting hospital's medical staff or, in the case of a transfer, a member of the accepting hospital's medical staff determines that the person is in need of emergency care. "Emergency care" means treatment which is usually and customarily available at the respective hospital and that must be provided immediately to sustain a person's life, to prevent serious permanent disfigurement, or loss or impairment of the function of a bodily member or organ, or to provide for the care of a woman in active labor if the hospital is so equipped and, if the hospital is not so equipped, to provide necessary treatment to allow the woman to travel to a more appropriate facility without undue risk of serious harm. In addition to or in lieu of any action taken by the South Carolina Department of Health and Environmental Control affecting the license of any hospital, when it is established that any officer, employee, or member of the hospital medical staff has recklessly violated the provisions of this section, the department may require the hospital to pay a civil penalty of up to ten thousand dollars.
Health care facilities licensed pursuant to Regulation 61-16, Minimum Standards for Licensing Hospitals and Institutional General Infirmaries, and designated as "privately-owned education infirmaries" may be established within the jurisdiction of a larger nonmedical institution which maintains and operates organized facilities and services to accommodate two or more nonrelated students, faculty, and staff with illness, injury, or infirmity for a period exceeding twenty-four hours for the diagnosis, treatment, and care of such persons and which provides medical, surgical, and professional nursing care, and in which all diagnoses, treatment, and care are performed under the direction of persons currently licensed to practice medicine and surgery in South Carolina. However, privately-owned education infirmaries also may care for patients who are not students, faculty, or staff when the privately-owned education infirmary has agreed to provide such care to this class or patients prior to January 1, 2007.
SECTION 44-7-262. Minimum resident-staff ratios for nursing homes.
(A) As a condition of licensure, in addition to the number of licensed nursing personnel required by R61-17, or any other regulation, a nursing home must provide at a minimum these resident-staff ratios for staff who provide nursing care:
(1) 9 to 1 for shift 1;
(2) 13 to 1 for shift 2;
(3) 22 to 1 for shift 3.
In those facilities utilizing two twelve-hour shifts, the staffing ratios for shift one apply to the twelve-hour shift occurring primarily during the day, and the staffing ratios for shift three apply to the twelve-hour shift occurring primarily during the night.
(B) For purposes of this section:
(1) "Shift 1" means a work shift that occurs primarily during the daytime hours including, but not limited to, a 7:00 a.m. to 3:00 p.m. shift;
(2) "Shift 2" means a work shift that generally includes both daytime and evening hours including, but not limited to, a 3:00 p.m. to 11:00 p.m. shift;
(3) "Shift 3" means a work shift that occurs primarily during the nighttime hours including, but not limited to, an 11:00 p.m. to 7:00 a.m. shift.
SECTION 44-7-265. Freestanding or mobile technology regulations to be promulgated.
The department shall promulgate regulations for licensing freestanding or mobile technology. At a minimum, the regulations must include:
(1) standards for the maintenance and operation of freestanding or mobile technology to ensure the safe and effective treatment of persons served;
(2) a description of the professional qualifications necessary for personnel to operate the equipment and interpret the test results;
(3) minimum staffing requirements to ensure the safe operation of the equipment and interpret the test results; and
(4) that all freestanding or mobile technology must be in conformance with professional organizational standards.
Applicants for a license shall file annually applications under oath with the department upon prescribed forms. An application must be signed by the owner, if an individual or a partnership, or in the case of a corporation by two of its officers, or in the case of a government unit by the head of the governmental department having jurisdiction over it. The application must set forth the full name and address of the facility for which the license is sought and the full name and address of the owner, the names of the persons in control, and additional information as the department may require, including affirmative evidence of ability to comply with standards and regulations adopted by the department. Each applicant shall pay an annual license fee prior to issuance of a license as established by regulation.
SECTION 44-7-280. Issuance of license; expiration.
Licenses issued pursuant to this article expire one year after date of issuance or annually upon uniform dates prescribed by regulation. Licenses must be issued only for the premises and persons named in the application and are not transferable or assignable. Licenses must be posted in a conspicuous place on the licensed premises.
SECTION 44-7-290. Necessity of complying with article and regulations of department.
The department may not issue licenses for the operation of facilities or services subject to this article unless the facility and persons named in the application are found to comply with the provisions of this article and the department's regulations.
Prior to commencing the construction or alteration of facilities required to be licensed by this department, plans and specifications must be submitted to the department for review and approval in accordance with regulations of the department. If construction has commenced without submittal of plans and specifications, an applicant for a license is required to submit certified drawings for review and approval prior to action upon the application for a license.
SECTION 44-7-310. Certain information not to be disclosed publicly.
Information received by the Office of Health Licensing of the department through inspection or otherwise which does not appear on the face of the license may not be disclosed publicly in a manner as to identify individuals or facilities except in a proceeding involving the licensure or certification of need of the facility or licensing proceedings against an employee of the facility or as ordered by a court of competent jurisdiction.
SECTION 44-7-315. Disclosure of information regarding facility or home.
(A) Information received by the Division of Health Licensing of the department, through inspection or otherwise, in regard to a facility licensed by the department pursuant to this article or subject to inspection by the department including a nursing home, a community residential care facility, or an intermediate care facility for the mentally retarded, or a group home operated by a county mental retardation board or the State Mental Retardation Department must be disclosed publicly upon written request to the department. The request must be specific as to the facility or home, dates, documents, and particular information requested. The department may not disclose the identity of individuals present in a facility licensed by the department pursuant to this article or subject to inspection by the department including a nursing home, a community residential care facility, an intermediate care facility for the mentally retarded, or a group home. When a report of deficiencies or violations regarding a facility licensed by the department pursuant to this article or subject to inspection by the department including a nursing home, a community residential care facility, an intermediate care facility for the mentally retarded, or a group home is present in the department's files when a request for information is received, the department shall inform the applicant that it has stipulated corrective action and the time it determines for completion of the action. The department also shall inform the applicant that information on the resolution of the corrective action order is expected to be available upon written request within fifteen days or less of the termination of time it determines for completion of the action. However, if information on the resolution is present in the files, it must be furnished to the applicant.
(B) This section does not apply to information considered confidential pursuant to Section 40-71-20 and Section 44-30-60.
SECTION 44-7-320. Denial, revocation, or suspension of license; penalties.
(A)(1) The department may deny, suspend, or revoke licenses or assess a monetary penalty against a person or facility for:
(a) violating a provision of this article or departmental regulations;
(b) permitting, aiding, or abetting the commission of an unlawful act relating to the securing of a Certificate of Need or the establishment, maintenance, or operation of a facility requiring certification of need or licensure under this article;
(c) conduct or practices detrimental to the health or safety of patients, residents, clients, or employees of a facility or service. This provision does not refer to health practices authorized by law;
(d) refusing to admit and treat alcoholic and substance abusers, the mentally ill, or the mentally retarded, whose admission or treatment has been prescribed by a physician who is a member of the facility's medical staff; or discriminating against alcoholics, the mentally ill, or the mentally retarded solely because of the alcoholism, mental illness, or mental retardation;
(e) failing to allow a team advocacy inspection of a community residential care facility by the South Carolina Protection and Advocacy System for the Handicapped, Inc., as allowed by law.
(2) Consideration to deny, suspend, or revoke licenses or assess monetary penalties is not limited to information relating to the current licensing year but includes consideration of all pertinent information regarding the facility and the applicant.
(3) If in the department's judgment conditions or practices exist in a facility that pose an immediate threat to the health, safety, and welfare of the residents, the department immediately may suspend the facility's license and shall contact the appropriate agencies for placement of the residents. Within five days of the suspension a preliminary hearing must be held to determine if the immediate threatening conditions or practices continue to exist. If they do not, the license must be immediately reinstated. Whether the license is reinstated or suspension remains due to the immediate threatening conditions or practices, the department may proceed with the process for permanent revocation pursuant to this section.
(B) Should the department determine to assess a penalty, deny, suspend, or revoke a license, it shall send to the appropriate person or facility, by certified mail, a notice setting forth the particular reasons for the determination. The determination becomes final thirty days after the mailing of the notice, unless the person or facility, within such thirty-day period, requests in writing a contested case hearing before the board, or its designee, pursuant to the Administrative Procedures Act. On the basis of the contested case hearing, the determination involved must be affirmed, modified, or set aside. Judicial review may be sought in accordance with the Administrative Procedures Act.
(C) The penalty imposed by the department for violation of this article or its regulations must be not less than one hundred nor more than five thousand dollars for each violation of any of the provisions of this article. Each day's violation is considered a subsequent offense.
(D) Failure to pay a penalty within thirty days is grounds for suspension, revocation, or denial of a renewal of a license. No license may be issued, reissued, or renewed until all penalties finally assessed against a person or facility have been paid.
(E) No Certificate of Need may be issued to any person or facility until a final penalty assessed against a person or a facility has been paid.
(F) All penalties collected pursuant to this article must be deposited in the state treasury and credited to the general fund of the State.
SECTION 44-7-325. Fee for search and duplication of medical record; time limits for compliance with request for record.
(A) A health care facility, as defined in Section 44-7-130, and a health care provider licensed pursuant to Title 40 may charge a fee for the search and duplication of a medical record, but the fee may not exceed sixty-five cents per page for the first thirty pages and fifty cents per page for all other pages, and a clerical fee for searching and handling not to exceed fifteen dollars per request plus actual postage and applicable sales tax. However, no fee may be charged for records copied at the request of a health care provider or for records sent to a health care provider at the request of the patient for the purpose of continuing medical care. The facility or provider may charge a patient or the patient's representative no more than the actual cost of reproduction of an X-ray. Actual cost means the cost of materials and supplies used to duplicate the X-ray and the labor and overhead costs associated with the duplication.
(B) Except for those requests for medical records pursuant to Section 42-15-95:
(1) A health care facility shall comply with a request for copies of a medical record no later than forty-five days after the patient has been discharged or forty-five days after the request is received, whichever is later.
(2) Nothing in this section may compel a health care facility to release a copy of a medical record prior to thirty days after discharge of the patient.
The department, in accordance with the laws of this State governing injunctions and other processes, may maintain an action in the name of the State against any person or facility for violation of this article and regulations promulgated under this article. In charging any defendant in a complaint in an action, it is sufficient to charge that the defendant, upon a certain day and in a certain county, did violate any provision of this article or of the regulations promulgated without the necessity for showing irreparable harm.
SECTION 44-7-340. Violation as misdemeanor; fines.
Any person or facility violating any of the provisions of this article or a regulation under this article is guilty of a misdemeanor and, upon conviction, must be fined not more than one hundred dollars for the first offense and not more than five thousand dollars for a subsequent offense. Each day's violation after a first conviction constitutes a subsequent offense.
SECTION 44-7-345. Discrimination prohibited in admission of individuals to residential care facilities.
Community residential care facilities licensed pursuant to this article which receive public funds, including funds appropriated in Part I of the appropriation act, directly or indirectly, including those instances where payment of an optional state supplement from the South Carolina Department of Social Services is made to a resident, their designated representative payee, or guardian, rather than directly to a facility, may not deny admission or services to an individual on the basis of race, color, national origin, qualified handicap, sex, or age.
SECTION 44-7-350. Community residential care facility.
The agency placing a client in a community residential care facility shall develop an individual plan of care in cooperation with the provider. The placing agency shall monitor the plan to the extent considered appropriate by the placement agency.
Prior to a community residential care facility being licensed for operation in an area which is outside incorporated areas of a county, the following conditions must be met:
(1) The governing body for the area must be given notice of the proposed location.
(2) Where the governing body objects to the proposed site for the facility, the arbitration procedures set forth in Act 449 of 1978 must be employed.
Community residential care facilities are required to furnish an item-by-item billing for all charges to the resident or the person paying the bill, upon request by the resident or person paying the bill. Items which remain unpaid are not required to be itemized again. A request for itemized billing remains in effect until further notification by the resident or person paying the bill. The provisions of this section do not apply to the contracted amount of a state agency. Any amount above the contract must be itemized accordingly. Residents receiving an optional supplement from the State Department of Social Services must not be charged an amount greater than that set by that department.
SECTION 44-7-370. Residential Care Committee; Renal Dialysis Advisory Council.
(A) The South Carolina Department of Health and Environmental Control shall establish a Residential Care Committee to advise the department regarding licensing and inspection of community residential care facilities.
(1) The committee consists of the Long Term Care Ombudsman, three operators of homes with ten beds or less, four operators of homes with eleven beds or more, and three members to represent the department appointed by the commissioner for terms of four years.
(2) The terms must be staggered and no member may serve more than two consecutive terms. Any person may submit names to the commissioner for consideration. The advisory committee shall meet at least once annually with representatives of the department to evaluate current licensing regulations and inspection practices. Members shall serve without compensation.
(B) The Department of Health and Environmental Control shall appoint a Renal Dialysis Advisory Council to advise the department regarding licensing and inspection of renal dialysis centers. The council must be consulted and have the opportunity to review all regulations promulgated by the board affecting renal dialysis prior to submission of the proposed regulations to the General Assembly.
(1) The council is composed of a minimum of fourteen persons, one member recommended by the Palmetto Chapter of the American Nephrology Nurses Association; one member recommended by the South Carolina Chapter of the National Association of Patients on Hemodialysis and Transplants; three physicians specializing in nephrology recommended by the South Carolina Renal Physicians Association; two administrators of facilities certified for dialysis treatment or kidney transplant services; one member recommended by the South Carolina Kidney Foundation; one member recommended by the South Carolina Hospital Association; one member recommended by the South Carolina Medical Association; one member of the general public; one member representing technicians working in renal dialysis facilities; one member recommended by the Council of Nephrology Social Workers; and one member recommended by the Council of Renal Nutritionists. The directors of dialysis programs at the Medical School of the University of South Carolina and the Medical University of South Carolina, or their designees, are ex officio members of the council.
(2) Members shall serve four-year terms and until their successors are appointed and qualify. No member of council shall serve more than two consecutive terms. The council shall meet as frequently as the board considers necessary, but not less than twice each year. Members shall serve without compensation.
SECTION 44-7-380. Surgical technology and operating room circulators; definitions; requirements to practice; exceptions.
(A) As used in this section, "surgical technology" means intraoperative surgical patient care that involves:
(1) preparing the operating room for surgical procedures by ensuring that surgical equipment is functioning properly and safely;
(2) preparing the operating room and the sterile field for surgical procedures by preparing sterile supplies, instruments, and equipment using sterile technique;
(3) anticipating the needs of the surgical team based on knowledge of human anatomy and pathophysiology and how they relate to the surgical patient and the patient's surgical procedure; and
(4) as directed within the sterile field in an operating room setting, performing tasks including:
(a) passing supplies, equipment, or instruments;
(b) sponging or suctioning an operative site;
(c) preparing and cutting suture materials;
(d) transferring fluids or drugs;
(e) holding retractors; and
(f) assisting in counting sponges, needles, supplies, and instruments.
(B)(1) A person may not practice surgical technology in a health care facility unless the person meets one of the following requirements:
(a) has successfully completed an accredited educational program for surgical technologists and holds and maintains the Surgical Technologist Certification administered by the National Board of Surgical Technology and Surgical Assisting, or its successor; however, upon completion of an accredited education program for surgical technologists, graduates may practice for up to three months before completing certification by the National Board of Surgical Technology and Surgical Assisting, or its successor;
(b) has completed an appropriate training program for surgical technology in the United States Army, Navy, Air Force, Marine Corps, or Coast Guard or in the United States Public Health Service;
(c) provides evidence that the person was employed to practice surgical technology in a health care facility in this State prior to January 1, 2008; or
(d) is in the service of the federal government, to the extent the person is performing duties related to that service.
(2) A person qualified to practice as a surgical technologist pursuant to subsection (B)(1) remains qualified to practice regardless of a break in practice provided the continuing education required in subsection (D) is current.
(C) A person who does not meet the requirements of this section, may practice surgical technology in a health care facility if:
(1) after a diligent and thorough effort has been made, the health care facility is unable to employ a sufficient number of persons who meet the requirements of this section; and
(2) the health care facility makes a written record of its efforts made pursuant to item (1) and retains the record at the health care facility.
(D) A person who qualifies to practice surgical technology in a health care facility pursuant to subsection (B)(1)(a), (b), or (c) annually must complete fifteen hours of continuing education to remain qualified for employment.
(E) A health care facility that employs a person to practice surgical technology shall verify that the person meets the continuing education requirements of subsection (D) or that the person has held and maintained the Surgical Technologist Certification as required in subsection (B)(1)(a).
(F) A health care facility shall supervise each person employed by the health care facility to practice surgical technology according to the health care facility's policies and procedures to ensure that the person competently performs delegated tasks intraoperatively according to this section or other applicable provisions of law.
(G) This section does not prohibit a person licensed under another provision of law from performing surgical technology tasks or functions if the person is acting within the scope of his or her license.
SECTION 44-7-385. Requirements for serving as operating room circulator.
(A) As used in this section, an "operating room circulator" means a registered nurse trained, educated, or experienced in perioperative nursing who is responsible for coordinating the nursing care and safety needs of a patient in the operating room and who also meets the needs of the operating room team members during surgery.
(B) An operating room circulator in a health care facility must be a licensed registered nurse educated, trained, and experienced in perioperative nursing.
(C) A surgical technologist may not serve as the circulator in the operating room of a health care facility; however, a person who is employed to practice surgical technology in a health care facility may assist in the performance of circulating duties:
(1) consistent with the person's education, training, and experience; and
(2) as assigned and supervised by a registered nurse circulator who must be present in the operating room for the duration of the surgical procedure.
The General Assembly makes the following findings:
(1) that the cost of improved health technology and scientific methods contributes significantly to the increasing cost of health care;
(2) that cooperative agreements among hospitals health care purchasers, and other health care providers would foster improvements in the quality of health care for South Carolinians, moderate cost increases, improve access to needed services in rural areas, and enhance the likelihood that rural hospitals can remain open;
(3) that federal and state antitrust laws may prohibit or discourage cooperative agreements that are beneficial to South Carolinians and that such agreements should be encouraged; and
(4) that competition as currently mandated by federal and state antitrust laws should be supplanted by a regulatory program to permit and encourage cooperative agreements between hospitals, health care purchasers, or other health care providers when the benefits outweigh the disadvantages caused by their potential adverse effects on competition.
(1) "Affected persons" means a health care provider or purchaser:
(a) who provides or purchases the same or similar health care services in the geographic area served or to be served by the applicants for a certificate of public advantage: or
(b) who has notified the department of his interest in applications for certificates of public advantage and has a direct economic interest in the decision. Other than health insurers licensed in South Carolina, persons from other states who would otherwise be considered "affected persons" are not included unless that state provides for similar involvement of persons from South Carolina in a similar process in that state.
(2) "Certificate of public advantage" means the formal approval, including any conditions or modifications, by the department of a contract, business or financial arrangement, or other activities or practices between two or more health providers, health provider networks, or health care purchasers that might be construed to be violations of state or federal antitrust laws.
(3) "Cooperative agreement" means an agreement between two health providers, health provider networks, or purchasers or among more than two health care providers, health provider networks, or purchasers for the sharing, allocation, or referral of patients or the sharing or allocation of personnel, instructional programs, support services and facilities, medical, diagnostic or laboratory facilities, procedures, equipment, or other health care services traditionally offered by health care facilities or other health care providers or the acquisition or merger of assets among or by two or more health providers, health provider networks, or health care purchasers, provided the agreement does not involve price-fixing or predatory pricing or illegal tying arrangements.
(4) "Department" means the Department of Health and Environmental Control.
(5) "Health care provider" means a health care professional licensed, certified, or registered under the laws of this State, an organization licensed pursuant to Section 44-69-30 or Section 44-71-30, or a facility licensed pursuant to Section 44-7-260 or Section 44-89-40 to provide health care services or any other person as defined in Section 44-7-130(15) who provides health services in a freestanding or mobile facility.
(6) "Health care purchaser" means a person or organization that purchases health care services on behalf of an identified group of persons, regardless of whether the cost of coverage of services is paid for by the purchaser or by the person receiving coverage or services including, but not limited to:
(a) health insurers as defined by Section 38-71-920;
(b) employee health plans offered by self-insured employers;
(c) group health coverage offered by fraternal organizations, professional associations, or other organizations;
(d) state and federal health care programs; and
(e) state and local public employee health plans.
(7) "Health provider networks" means an organization of health care providers which offers health services to residents of this State. An organization may be a partnership, corporation including an association, a joint stock company, or any other legal entity recognized by the State.
(8) "Federal or state antitrust laws" means a federal or state law prohibiting monopolies or agreements in restraint of trade, including the Federal Sherman Act and Clayton Act, the Federal Trade Commission Act, and Chapters 3 and 5 of Title 39 of the 1976 Code.
(A) It is the intent of this article to require the State to provide direction, supervision, regulation, and control over approved cooperative agreements through the department and the Attorney General. This state direction, supervision, regulation, and control of cooperative agreements will provide immunity for health care providers, health provider networks, or purchasers who participate in discussions or negotiations authorized by this article from civil liability and criminal prosecution under federal or state antitrust laws.
(B) A health care provider, health provider network, or health care purchaser may negotiate, enter into, and conduct business pursuant to a cooperative agreement without being subject to damages, liability, or scrutiny under any state antitrust law. In addition, conduct in negotiating and entering into a cooperative agreement for which an application for a certificate of public advantage is filed in good faith is immune from challenge or scrutiny under state antitrust laws, regardless of whether a certificate is issued. It is the intention of the General Assembly that this article immunizes covered activities from challenge or scrutiny under federal antitrust laws. Nothing in this subsection creates immunity for a person for conduct in negotiating or entering into a cooperative agreement for which an application for a certificate of public advantage is not filed.
A health care provider, health care purchaser, or health provider network may negotiate and enter into cooperative agreements with other health care providers or health provider networks or health care purchasers if the likely benefits resulting from the agreements outweigh any likely disadvantages resulting from the agreements. Parties to a cooperative agreement may apply to the department for a certificate of public advantage. The application must include an executed written copy of the cooperative agreement and describe the nature and scope of the cooperation in the agreement and any monetary or other consideration passing to a party under the agreement including change of ownership, merger, or other change in control of the assets of either party. Information obtained by the department under this section must be available to the public unless the department certifies the information as being proprietary. The department may make this certification where a person shows to the satisfaction of the department that the information should be proprietary. The department may require an application fee from the submitting parties sufficient to cover the cost of processing the application.
SECTION 44-7-540. Publish; notice of receipt of application.
Upon receipt of an application, the department shall publish in the State Register notice of receipt of the application. The department shall review the application in accordance with the standards set forth in Section 44-7-560 and if requested by an affected person within thirty days of the department's receipt of a completed application, may hold a public hearing in accordance with regulations promulgated by the department. Within thirty days of receipt of the application, the department may request additional information as may be necessary to complete the application. The applicant has thirty days from the date of the request to submit the additional information. If the applicant fails to submit the requested information within the thirty-day period, the application is considered withdrawn. However, the department may grant one fifteen-day extension for the applicant to submit this information. The department shall grant or deny the application within sixty days after receipt of a completed application or from the date of the public hearing, if one is requested, and that decision must be in writing and must set forth the basis for the decision. The department shall furnish a copy of the decision to the applicants and any affected persons who have asked to be notified. The department shall publish its decisions in the State Register.
SECTION 44-7-550. Review of application; advisement by the Attorney General; to the department to approve or deny application.
(A) Upon receipt of a completed application the department shall forward a copy of the application to the Attorney General. The Attorney General shall review the request not later than thirty days after receiving the completed application. The Attorney General may advise the department, in writing, to approve or deny the application. Failure by the Attorney General to notify the department within thirty days of receiving a completed application constitutes a recommendation for approval of the request. Advisement by the Attorney General to the department to deny a request shall set forth the reasons for the denial.
(B) Upon receipt of the advice of the Attorney General or at the end of the review period outlined in Section 44-7-540, the department shall issue an order approving or denying the application for a certificate of public advantage. Upon request from the applicant or an affected person, the department's order to approve or deny the application for the certificate is entitled to judicial review in accordance with the Administrative Procedures Act.
SECTION 44-7-560. Issuance of a certificate of public advantage for a cooperative agreement.
(A) The department shall issue a certificate of public advantage for a cooperative agreement if it determines that:
(1) the applicants have demonstrated that the likely benefits resulting from the agreement outweigh the likely disadvantages from the agreement;
(a) in evaluating the benefits likely to result from the cooperative agreement, the department shall consider, but is not limited to:
(i) enhancement of the quality of health and health related care provided to South Carolina citizens;
(ii) preservation of health care providers close to communities traditionally served by those providers;
(iii) gains in the cost-efficiency of the services offered by the health care providers or purchasers involved;
(iv) improvements in the use of health care provider resources and equipment;
(v) avoidance or elimination or reduction of duplication of health care resources;
(vi) improvement in access to health care for citizens in the community;
(vii) support of the agreement by purchasers and payers in the health service area;
(viii) the extent of financial risk-sharing by the parties as a result of the agreement;
(ix) the provision or enhancement of health care services to Medicaid, indigent, or charity care patients by the parties to the agreement.
(b) In evaluating the disadvantages likely to result from the agreement, the department shall consider, but is not limited to:
(i) the likely adverse impact, if any, on the ability of the health care purchasers to negotiate optimal payment and service arrangements with the health care providers or health provider networks;
(ii) the extent of any reduction in competition among health care providers, purchasers, or other persons furnishing goods or services to or in competition with health care providers or purchasers that is likely to result directly or indirectly from the health care cooperative agreement;
(iii) the likely adverse impact, if any, on patients in the quality, availability, and price of health care services;
(iv) the extent to which the agreement may increase the costs of prices of health care at a hospital or other health care provider which is a party to the agreement;
(v) the extent to which services to Medicaid, indigent, or charity care patients are adversely impacted by the agreement; and
(2) reduction in competition likely to result from the agreement is reasonably necessary to obtain the benefits likely to result. In evaluating whether the reduction in competition is necessary to obtain the likely benefits, the department shall consider, but is not limited to:
(a) the availability of arrangements that:
(i) are less restrictive to competition and achieve the same benefits;
(ii) offer a more favorable balance of benefits over disadvantages attributable to a reduction in competition likely to result from the agreement.
(b) the ease with which health care providers or health care purchasers may obtain contracts with other health plans;
(c) the difficulty in establishing new competing health plans in the relevant geographic market, including the ability to offer services requiring a certificate of need or purchasing these services from another health care provider or health provider network; and
(d) the sufficiency of the number or type of providers under contract with the health plan available to meet the needs of plan enrollees.
(B) The department also may establish conditions for approval that are reasonably necessary to ensure that the cooperative agreement and the activities engaged under it are consistent with this article and its purpose to promote cooperation and limit health care costs, protect against abuse of private economic power, and to ensure that the activity is appropriately supervised and regulated by the State.
