ARTICLE 44:76
AMBULATORY SURGERY CENTER FACILITIES
Chapter
44:76:01 Rules of general applicability.
44:76:02 Physical environment.
44:76:03 Fire protection.
44:76:04 Management and administration.
44:76:05 Physician services.
44:76:06 Nursing and related care services.
44:76:07 Medication control.
44:76:08 Medical record services.
44:76:09 Diagnostic services.
44:76:10 Surgical services.
44:76:11 Construction standards.
44:76:12 Additional ambulatory surgery center standards.
44:76:13 Patient's rights.
CHAPTER 44:76:01
RULES OF GENERAL APPLICABILITY
Section
44:76:01:01 Definitions.
44:76:01:02 Posting of license.
44:76:01:03 Name of facility.
44:76:01:04 Facility capacity.
44:76:01:05 Restrictions on acceptance of patients.
44:76:01:06 Joint occupancy.
44:76:01:07 Reports.
44:76:01:08 Plans of correction.
44:76:01:09 Scope of article.
44:76:01:01. Definitions. Terms defined in SDCL 34-12-1.1 have the same meaning in this article. In addition, terms used in this article mean:
(1) "Abuse," an intentional act toward an individual indicating that one or more of the following has occurred:
(a) A criminal conviction against a person for mistreatment toward an individual; or
(b) In the absence of a criminal conviction, substantial evidence that one or more of the following has occurred resulting in harm, pain, fear, or mental anguish:
(i) Misappropriation of a patient's or resident's property or funds;
(ii) An attempt to commit a crime against a patient or resident;
(iii) Physical harm or injury against a patient or resident; or
(iv) Using profanity, making a gesture, or engaging in any other act made to or directed at a patient or resident;
(2) "Activities of daily living," the tasks of transferring, moving about, dressing, grooming, toileting, bathing, and eating performed routinely by a person to maintain physical functioning and personal care;
(3) "Adequate staff," a sufficient number of qualified personnel to perform the duties required to meet the performance criteria established by this article;
(4) "Administrator," a person appointed by the owner or governing body of a facility who is responsible for managing the facility and who maintains an office on the premises of the facility;
(5) "Anesthesiologist," a physician whose specialized training and certification qualify the person to administer anesthetic agents and to monitor the patient under the influence of these agents;
(6) "Anesthetist," a physician eligible for certification as an anesthesiologist or a certified registered nurse anesthetist who meets the requirements of SDCL chapter 36-9;
(7) "Client advocate," any agency responsible for the protection and advocacy of patients, including the department, the state ombudsman, the protection and advocacy network, and the Medicaid fraud control unit;
(8) "Clinical Nurse Specialist," a person who practices the nurse specialty of a clinical nurse specialist as authorized pursuant to SDCL chapter 36-9;
(9) "Circulating Nurse," a registered nurse trained, educated, or experienced in perioperative nursing who is responsible for coordinating and monitoring the nursing care and safety needs of a patient in the operating or procedure room and who also meets the needs of the operating room or procedure room team members during surgery. The circulating nurse works outside the sterile field in which the procedure takes place and duties include but are not limited to recording the progress of the procedure, accounting for instruments, and handling specimens.
(10) "Department," the South Dakota Department of Health;
(11) "Developmental disability," a severe, chronic disability of a person as defined in SDCL 27B-1-18 or a disability which:
(a) Is attributable to a mental or physical impairment or combination of mental and physical impairments;
(b) Is manifested before the person attains age 22;
(c) Is likely to continue indefinitely;
(d) Results in substantial functional limitations in three or more of the following areas of major life activity:
(i) Self-care;
(ii) Receptive and expressive language;
(iii) Learning;
(iv) Mobility;
(v) Self-direction;
(vi) Capacity for independent living; and
(vii) Economic self-sufficiency; and
(e) Reflects the person's need for an array of generic services, met through a system of individual planning and supports over an extended time, including those of a life-long duration;
(12) "Dietitian," a person who is registered with the Academy of Nutrition and Dietetics and holds a current license to practice in South Dakota pursuant to SDCL chapter 36-10B;
(13) "Emergency care," professional health services immediately necessary to preserve life or stabilize health due to the sudden, severe, and unforeseen onset of illness or accidental bodily injury;
(14) "Exploitation," the wrongful taking or exercising of control over property of a person with intent to defraud that person;
(15) "Facility," the ambulatory surgical center licensed by the department that is not part of a hospital and which is not an office of a dentist, in which surgical procedures requiring the use of general anesthesia are performed upon patients;
(16) "General hospital," a hospital that provides at least medical, surgical, obstetrical, and emergency services;
(17) "Governing body," an organized body of persons that is ultimately responsible for the quality of care in a health care facility, credentialing of and granting privileges to the medical staff, maintaining the financial viability of the facility, and formulating institutional policy;
(18) "Healthcare worker," any paid person working in a health-care setting;
(19) "Hospital," is a general hospital, specialized hospital, or critical access hospital.
(20) "Interdisciplinary team," a group of persons selected from multiple health disciplines who have a diversity of knowledge and skills and who function as a unit to collectively address the medical, physical, mental or cognitive, and psychosocial needs of a patient;
(21) "Legend drug," any drug that requires the label bearing the statement "Caution: Federal law prohibits dispensing without prescription";
(22) "Licensed health professional," a physician; physician's assistant; nurse practitioner; clinical nurse specialist, physical therapist, speech-language pathologist, occupational therapist; physical or occupational therapy assistant; nurse; nursing facility administrator; dietitian; pharmacist; respiratory therapist; or social worker who holds a current license to practice in South Dakota;
(23) "Medical staff," an organized staff composed of practitioners that operates under bylaws approved by the governing body and which is responsible for reviewing the qualifications of practitioners applying for clinical privileges and for the provision of medical care to patients in a health care facility;
(24) "Mental disease," a mental condition that causes a person to lack sufficient understanding or capacity to make the responsible decisions to meet the ordinary demands of life, as evidenced by the person's behavior, or that causes a person to be a danger to self or others;
(25) "Misappropriation of patient or resident property," the deliberate misplacement, exploitation, or wrongful, temporary or permanent use of a patient's or resident's belongings or money without the patient's or resident's consent;
(26) "Neglect," harm to a person's health or welfare, without reasonable justification, caused by the conduct of someone responsible for the person's health or welfare, including offensive behavior made to or directed at a patient or resident, and the failure to provide timely, consistent, and safe services, treatment, or care necessary to avoid physical harm, mental anguish, or mental illness to the person;
(27) "Nurse," a registered nurse or a licensed practical nurse who holds a current license to practice in South Dakota pursuant to SDCL chapter 36-9;
(28) "Nurse aide," an individual providing nursing or nursing-related services who is not a licensed health professional, or someone who volunteers to provide such services without pay;
(29) "Nurse practitioner," a person who practices the specialty nurse practitioner as authorized pursuant to SDCL chapter 36-9A;
(30) "Nursing personnel," staff which includes registered nurses, licensed practical nurses, nurse aides, patient care technicians, and restorative aides;
(31) "Nursing unit," a patient unit that is limited to one floor of a health care facility and has all patient room entrances and exits within sight or control of nursing personnel;
(32) "Patient," a person with a valid order by a practitioner for surgical services that does not require hospitalization and in which the expected duration of services would not exceed 24 hours and not require an overnight stay in an ambulatory surgical center;
(33) "Pharmacist," a person registered to practice pharmacy pursuant to SDCL chapter 36-11;
(34) "Physician," a person who is licensed or approved to practice medicine pursuant to SDCL chapter 36-4;
(35) "Physician assistant," a health care professional who meets the qualifications as defined and is licensed as authorized pursuant to SDCL chapter 36-4A;
(36) "Practitioner," one of the following:
(a) A physician or surgeon licensed or approved to practice medicine pursuant to SDCL chapter 36-4;
(b) A dentist licensed pursuant to SDCL chapter 36-6;
(c) A podiatrist licensed pursuant to SDCL chapter 36-8;
(d) An optometrist licensed pursuant to SDCL chapter 36-7;
(e) A chiropractor licensed pursuant to SDCL chapter 36-5;
(f) A pharmacist licensed pursuant to SDCL chapter 36-11;
(g) A nurse practitioner licensed pursuant to SDCL chapter 36-9A;
(h) A physician assistant licensed pursuant to SDCL chapter 36-4A;
(i) A clinical nurse specialist pursuant to SDCL chapter 36-9; or
(37) "Protection and advocacy network," agencies responsible for the protection and advocacy of individuals with developmental disabilities or mental illness, established under the Developmental Disabilities Assistance and Bill of Rights Act of 2000, Pub. L. No. 106-402 (October 30, 2000), codified at 42 U.S.C. § 15041 to 15045, and the Protection and Advocacy for Persons with Mental Illness Act of 2000, Pub. L. No. 106-310 (October 17, 2000), codified at 42 U.S.C. §§ 10801 to 10851, inclusive;
(38) "Qualified personnel," persons with the specific education or training to provide the health service for which they are employed;
(39) "Rehabilitation services," services which include physical therapy, occupational therapy, respiratory therapy, and speech therapy;
(40) "Restraint," a physical, chemical, or mechanical device used to restrict the movement of a patient or the movement or normal function of a portion of the patient's body, excluding devices used for specific medical and surgical treatment;
(41) "Self-administration of medications," the removal of the correct dosage from the pharmaceutical container and self-injecting, self-ingesting, or self-applying the medication with no assistance or with assistance from qualified personnel of the facility for the correct dosage or frequency;
(42) "Social worker," a person who is licensed pursuant to SDCL chapter 36-26;
(43) "Specialized hospital," a hospital that provides only one service or a combination of services but does not provide all of the services required to qualify as a general hospital;
(44) "Transfer or discharge," the movement of a patient outside the facility;
(45) "Treatment," a medical aid provided for the purposes of palliating symptoms, improving functional level, or maintaining or restoring health; and
(46) "Unlicensed assistive personnel," a person who is not licensed as a nurse under SDCL chapter 36-9 but who is trained to assist a licensed nurse in the provision of nursing care to a patient as delegated by the nurse and authorized by chapter 20:48:04.01.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13, 34-12-32.
44:76:01:02. Posting of License. The most current license issued by the department shall be posted on the premises of the facility in a place conspicuous to the public. Each facility address shall show a current license. The license certificate remains the property of the department.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-7.
Law Implemented: SDCL 34-12-7.
44:76:01:03. Name of facility. Each facility shall be designated by a pertinent and distinctive name that shall be used in applying for a license. The name may not be changed without first notifying the department in writing. No facility may be given a name or advertise in a way that implies services rendered are in excess of the classification for which it is licensed or which would indicate an ownership other than actual.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-7.
Law Implemented: SDCL 34-12-7.
44:76:01:04. Facility capacity. The department shall establish the capacity of each facility pursuant to the physical plant and space provisions of this article. The patient census may not exceed the capacity for which the facility is designed. A request by the facility for an adjustment in capacity because of change of purpose or construction shall be approved by the department before any changes are made.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-7, 34-12-13.
44:76:01:05. Restrictions on acceptance of patients. A facility shall accept patients in accordance with the following restrictions:
(1) A patient accepted for care by a licensed facility shall be treated within the facility covered by the license;
(2) A facility may not accept patients who require care in excess of the classification for which it is licensed;
(3) Nursing and other personnel essential to maintaining adequate staff may not leave a facility during their tour of duty in the facility to provide services to persons who are not patients of the facility with the exception of providing emergency care on premises contiguous to the facility's property;
(5) All facilities that accept patients suffering from developmental disabilities or mental diseases shall provide facilities and programs consistent with the needs of such patients;
(6) If persons are accepted for care or to participate in any programs or services their numbers shall be included in the evaluation of central use, activity, and staffing of nursing and programs; and the provision of an infection control program.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-7, 34-12-13(5).
Law Implemented: SDCL 34-12-7, 34-12-13(5).
44:76:01:06. Joint occupancy. The use of a portion of a building for a purpose other than that covered by the license may be approved by the department only if it can be shown that joint occupancy is not detrimental to the welfare of the patients. The area shall be open to inspection by the department.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:01:07. Reports. Each facility shall fax, email, or mail to the department the pertinent data necessary to comply with the requirements of all applicable administrative rules and statutes.
Any incident or event where there is reasonable cause to suspect abuse or neglect of any patient by any person shall be reported within 24 hours of becoming informed of the alleged incident or event. The facility shall report each incident or event orally or in writing to the state's attorney of the county in which the facility is located, to the Department of Social Services, or to a law enforcement officer. The incident or event shall also be reported to the department within 24 hours, and conduct a subsequent internal investigation and provide a written report of the results to the department within five working days after the event.
Each facility shall report to the department within 48 hours of the event any death resulting from other than natural causes originating on facility property such as accidents or suicide patient. The facility shall conduct a subsequent internal investigation and provide a written report of the results to the department within five working days after the event.
Each facility shall report a missing patient to the department within 48 hours. The facility shall conduct a subsequent internal investigation and provide a written report of the results to the department within five working days after the event.
Each facility shall also report to the department as soon as possible any fire with damage or where injury or death occurs; any partial or complete evacuation of the facility resulting from natural disaster; or any loss of utilities, such as electricity, natural gas, telephone, emergency generator, fire alarm, sprinklers, and other critical equipment necessary for operation of the facility for more than 24 hours.
Each facility shall notify the department of any anticipated closure or discontinuation of service at least 30 days in advance of the effective date.
Each facility shall report to the department any unsafe water samples for pools or spas.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(14).
Law Implemented: SDCL 34-12-13(14).
44:76:01:08. Plans of correction. Within 10 days of the receipt of the statement of deficiencies, each licensed facility shall submit to the department a written plan of correction for the citation of noncompliance with licensure requirements. The plan of correction shall be signed, dated, and on forms provided by the department. The department may reject the plan of correction if there is no evidence the plan will cause the facility to attain or maintain compliance with SDCL chapter 34-12 and this article.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:01:09. Scope of article. Nothing in article 44:76 limits or expands the rights of any healthcare worker to provide services within the scope of the professional's license, certification, or registration, as provided by South Dakota law.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
CHAPTER 44:76:02
PHYSICAL ENVIRONMENT
Section
44:76:02:01 Sanitation.
44:76:02:02 Pets.
44:76:02:03 Cleaning methods and facilities.
44:76:02:04 Chemicals used to sanitize, disinfect, or sterilize.
44:76:02:05 Sterilization.
44:76:02:06 Housekeeping cleaning methods and equipment.
44:76:02:07 Food service.
44:76:02:08 Handwashing facilities.
44:76:02:09 Linen.
44:76:02:10 Infection prevention and control.
44:76:02:11 Plumbing.
44:76:02:12 Water supply.
44:76:02:13 Ventilation.
44:76:02:14 Lighting.
44:76:02:15 Refuse and waste disposal.
44:76:02:16 Insect and rodent control.
44:76:02:17 Sewage disposal.
44:76:02:18 Occupant protection.
44:76:02:19 Area requirements.
44:76:02:20 Physical plant changes.
44:76:02:21 Location.
44:76:02:22 Heating and cooling.
44:76:02:23 Other hazardous conditions.
44:76:02:01. Sanitation. The facility shall be designed, constructed, maintained, and operated to minimize the sources and transmission of infectious diseases to patients, personnel, visitors, and the community at large. This requirement shall be accomplished by providing the physical resources, personnel, and technical expertise necessary to ensure good public health practices for institutional sanitation.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
44:76:02:02. Pets. No pet kept in or visiting a facility may negatively affect the well-being of a patient.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
Cross-Reference: Physically disabled, blind, or deaf person's right to be accompanied by guide dog without extra charge, SDCL 20-13-23.2.
44:76:02:03. Cleaning methods and facilities. The facility shall have supplies, equipment, work areas, and complete written procedures for cleaning, sanitizing, disinfecting, or sterilizing all work areas, equipment, utensils, and medical devices used for patients' care. Common use equipment shall be disinfected or sterilized after each use. Facilities shall have separate clean and soiled utility rooms.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(2).
Law Implemented: SDCL 34-12-13(2).
44:76:02:04. Chemicals used to sanitize, disinfect, or sterilize. The label of chemicals used to sanitize, disinfect, or sterilize shall indicate registration with the Environmental Protection Agency as effective, safe, and approved for their intended use.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(2).
Law Implemented: SDCL 34-12-13.(2)
44:76:02:05. Sterilization. Instruments, supplies, utensils and equipment which are not single service shall be decontaminated before sterilization in a manner that will make them safe for handling by personnel. Supplies and equipment commercially prepared and sterilized to retain sterility indefinitely are acceptable in lieu of sterilization in the facility. Autoclaves used for steam sterilization shall be bacteriologically monitored at least weekly. Supplies and equipment sterilized and packaged in the facility shall have the processing date on the package and shall be reprocessed in accordance with any specific manufacturer's recommendation for the packaging.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(2).
Law Implemented: SDCL 34-12-13(2).
44:76:02:06. Housekeeping cleaning methods and equipment. The facility shall establish written housekeeping procedures for the cleaning of all areas in the facility and copies made available to all housekeeping personnel. All parts of the facility shall be kept clean, neat, and free of visible soil, litter, and rubbish. Equipment and supplies shall be provided for cleaning of all surfaces. Such equipment shall be maintained in a safe, sanitary condition. Hazardous cleaning solutions, chemicals, poisons, and substances shall be labeled, stored in a safe place, and kept in an enclosed section separate from other cleaning materials. Cleaning of areas designed for patient use shall be performed by dustless methods that minimize the spread of pathogenic organisms in the facility's atmosphere. Each vacuum used in medical facilities shall be equipped to provide effective discharge air filtration of particles larger than 0.3 microns. Cleaning shall include all environmental surfaces within the facility that are subject to contamination from dust, direct splash, or pathogenic organisms except medical equipment, supplies, or devices that are the responsibility of other services or departments of the facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(2).
Law Implemented: SDCL 34-12-13(2).
44:76:02:07. Food service. Food services if provided shall meet the safety and sanitation procedures for food service in §§ 44:02:07:01, 44:02:07:02, and 44:02:07:04 to 44:02:07:95, inclusive, the Food Service Code. Any food service provided from an outside food establishment shall be inspected by a local, state, or federal agency. In addition, a mechanical dishwasher shall be provided in all facilities providing food service. The facility shall have the space, equipment, supplies, and mechanical systems for efficient, safe, and sanitary food preparation if any part of the food service is provided by the facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5) and (8).
Law Implemented: SDCL 34-12-13(5) and (8).
Note: Article 44:02, Lodging and Food Service, Administrative Rules of South Dakota, contains the Food Service Code and may be obtained from Legislative Mail, 1320 East Sioux Avenue, Pierre, South Dakota 57501, telephone (605) 773-4935, for $4.14.
44:76:02:08. Handwashing facilities. Handwashing facilities consisting of hot and cold running water dispensed through a mixing faucet controlled with blade handles or other hands-free controls, a towel dispenser with single-service towels or a hand-drying device, and hand cleanser shall be located in dietary areas, utility rooms, staff stations, pharmacies, laboratories, surgical suites, physical therapy rooms, restorative therapy rooms, examination and treatment rooms, laundry, and all toilet rooms. If existing faucets and controls are replaced or changed, they shall be replaced with mixing faucets controlled with blade handles or other hands-free controls.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (4).
Law Implemented: SDCL 34-12-13(1) and (4).
Cross-Reference: Plumbing fixture devices, § 44:76:12:14.
44:76:02:09. Linen. The supply of linens and towels shall equal three times the number of post operative rooms. The facility shall have written procedures for the storage and handling of soiled and clean linens. The facility shall contract with a commercial laundry service or the laundry service of another licensed health care facility for all common use linens if laundry services are not provided on the premises. A facility providing laundry services shall have adequate space and equipment for the safe and effective operation of the laundry service. Commingled patients' personal clothing, common-use linen, any isolation clothing, and housekeeping items shall be processed by methods that assure disinfection. The facility shall process laundry following the laundry equipment and cleaning agent recommendations. If hot water is used for disinfection, minimum water temperatures supplied for laundry purposes shall be 160 degrees Fahrenheit (71 degrees centigrade). If chlorine bleach is added to the laundry process to provide 100 parts per million or more of free chlorine, the minimum hot water temperatures supplied for laundry purposes may be reduced to 120 degrees Fahrenheit (48.8 degrees centigrade). The facility may choose to wash common-use linen and any isolation clothing in water temperatures less than 120º F. if the following conditions are met:
(1) The supplier of the chemical specifies low-temperature wash formulas in writing for the machines used in the facility;
(2) Charts providing specific information concerning the formulas to be used for each machine are posted in an area accessible to staff;
(3) The facility ensures that laundry staff receives in-service training by the chemical supplier on a routine basis, regarding chemical usage and monitoring of wash operations; and
(4) The facility ensures that staff monitors chemical usage and wash water temperatures at least monthly to ensure conformance with the chemical supplier's instructions.
Any clothing that is not commingled may be processed according to manufacturer's recommendations using water temperatures and detergent in quantity as recommended by the garment or detergent manufacturer. The facility shall have distinct areas for the storage and handling of clean and soiled linens. Those areas used for the storage and handling of soiled linens shall be negatively pressurized. The facility shall establish special procedures for the handling and processing of contaminated linens. Soiled linen shall be placed in closed containers prior to transportation. To safeguard clean linens from cross contamination, the linens shall be transported in containers used exclusively for clean linens, shall be kept covered with dust covers at all times while in transit or in hallways, and shall be stored in areas designated exclusively for this purpose. A written request for any modification of the requirements of this section shall be reviewed and approved by the department before any changes are made.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (4).
Law Implemented: SDCL 34-12-13(1) and (4).
44:76:02:10. Infection prevention and control. The infection prevention and control program shall utilize the concept of standard precautions. Bloodborne pathogen control shall be maintained according to the requirements contained in 29 C.F.R. 1910.1030, July 1, 2006. The facility shall designate a qualified professional with training in infection control to be responsible for the implementation of the infection control program including surveillance and reporting activities. There shall be written procedures that govern the use of aseptic techniques and procedures in all areas of the facility. Each facility shall develop policies and procedures for the handling and storage of potentially hazardous substances (including lab specimens). There shall be a method of control used in relation to the sterilization of supplies and a written policy requiring sterile supplies to be reprocessed. The facility shall provide orientation and continuing education to all personnel on the facility's staff on the cause, effect, transmission, prevention, and elimination of infections. Each facility shall develop a written policy for evaluation and reporting of any employee with a reportable infectious disease.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), 34-22-9(8).
Law Implemented: SDCL 34-12-13(1).
44:76:02:11. Plumbing. Facility plumbing systems shall be designed and installed in accordance with SDCL 36-25-15 and 36-25-15.1. Plumbing shall be sized, installed, and maintained to carry required quantities of water to required locations throughout the facility. Plumbing may not constitute a source of contamination of food equipment or utensils or create an unsanitary condition or nuisance.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (14).
Law Implemented: SDCL 34-12-13(1) and (14).
44:76:02:12. Water supply. The facility's water supply shall be obtained from a public water system or, in its absence, from a supply approved by the Department of Agriculture and Natural Resources. Each private water supply shall have a water sample bacteriologically tested at least monthly. The volume of water shall be sufficient for the needs of the facility, including fire fighting requirements. The hot water system shall be capable of supplying the work and patient areas with water at the required temperatures. Maximum hot water temperatures at plumbing fixtures used by patients may not exceed 125 degrees Fahrenheit (52 degrees centigrade). The minimum temperature of hot water for patient use shall be at least 100 degrees Fahrenheit (38 degrees centigrade).
Each water supply system shall maintain one part per million free residual chlorine at remote point-of-use fixtures in the facility or may use another bacteriological control method, such as increasing water temperature range from 122 degrees to 125 degrees Fahrenheit (50-52 degrees centigrade), that has been demonstrated to be equivalent in control of Legionella. The facility shall document water temperatures to verify the hot water temperature is being maintained within the acceptable range. The chlorine testing shall be done daily using photocell and light source DPD (N, N, Diethyl-p-phenylenediamine) test kits, and the test results logged. If testing demonstrates that consistent chlorine levels are maintained, the frequency of testing may be reduced to a level necessary to demonstrate compliance.
Source: 42 SDR 51, effective October 13, 2015; SL 2021, ch 1, §§ 8, 19, effective April 19, 2021.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
Cross-References: Standards adopted for plumbing -- Conformity to National Code, SDCL 36-25-15; Scope and objectives of plumbing standards and rules, SDCL 36-25-15.1.
44:76:02:13. Ventilation. Electrically powered exhaust ventilation shall be provided in all soiled areas, wet areas, toilet rooms, and storage rooms. Clean storage rooms may also be ventilated by supplying and returning air from the building's air-handling system.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
44:76:02:14. Lighting. Spaces occupied by people, machinery, and equipment within buildings and their approaches and parking lots shall have artificial lighting at a level for general safety. Required exits shall be equipped with continuous emergency lighting. Emergency power shall be provided if the main source of power fails.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
44:76:02:15. Refuse and waste disposal. Garbage, refuse, and waste shall be handled and disposed of in a safe and sanitary manner. Final disposal of all refuse and waste shall comply with articles 74:27 and 74:28. Putrescible garbage shall be removed at a frequency to contain or prevent odors, insects, and vermin.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
44:76:02:16. Insect and rodent control. The facility shall take effective measures to protect against the entrance into the facility and the breeding or presence on the premises of rodents, flies, roaches, and other vermin. The facility may use chemical substances of a poisonous nature in accordance with the requirements of this section to control or eliminate various types of vermin. The substances shall be properly colored and labeled to identify them as poisons, shall be used and stored in a safe manner, and may not be stored with food or drugs used for human consumption. Extreme care shall be taken to prevent any poisons from contaminating food or food products.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
44:76:02:17. Sewage disposal. Sewage shall be disposed of in a public sewage works system or, in its absence, in a manner approved by the department in accordance with the provisions of SDCL chapter 34A-2.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
44:76:02:18. Occupant protection. Each facility shall be constructed, arranged, equipped, maintained, and operated to avoid injury or danger to the occupants. The extent and complexity of occupant protection precautions is determined by the services offered and the physical needs of the patients admitted to the facility. The facility shall take at least the following precautions:
(1) Develop and implement a written and scheduled preventive maintenance program;
(2) Provide securely constructed and conveniently located grab bars in all toilet rooms and bathing areas used by patients;
(3) Provide a call system for each patient recovery station, preoperative and postoperative holding space, and in all toilet rooms and bathing facilities routinely used by patients. The call system shall be capable of being easily activated by the patient and shall register at a staff station serving the unit. A wireless call system may be used;
(4) Provide grounded or double-insulated electrical equipment or protect the equipment with ground fault circuit interrupters. Ground fault circuit interrupters shall be provided in wet areas and for outlets within six feet of sinks;
(5) A portable space heater, portable halogen lamp, household-type electric blanket, or house-hold heating pad may not be used in a facility;
(6) Any light fixture located over a patient recovery station, preoperative and postoperative holding spaces, in any bathing or treatment area, in a clean supply storage room, in any laundry clean linen storage area, or in any medication set-up area shall be equipped with a lens cover or a shatterproof lamp;
(7) Any clothes dryer shall have a galvanized metal vent pipe for exhaust; and
(8) The storage and transfilling of oxygen cylinders or containers shall meet the requirements of the NFPA 99 Standard for Health Care Occupancies, 2012 Edition.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
Reference: NFPA 99 Health Care Facilities, 2012 edition, National Fire Protection Association. Copies may be obtained from the National Fire Protection Association, P.O. Box 9101, Quincy, MA 02269-9101. Phone: 1-800-344-3555. Cost: $93.00.
44:76:02:19. Area requirements. Each facility shall be constructed, equipped, and operated to maintain the privacy and dignity of all patients. In a multi-patient recovery room, each patient recovery area shall be able to be separated from the other patients by privacy curtains.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:02:20. Physical plant changes. A facility shall submit any proposed change by new construction, remodeling, or change of use of an area to the department. Any change shall have the approval of the department before it is made.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:02:21. Location. The location of facilities shall promote the health, treatment, comfort, safety, and well-being of persons accepted and retained for care. Facilities shall be served by good, passable roads. Easy accessibility for employees, visitors, and fire-fighting services shall be maintained.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (14).
Law Implemented: SDCL 34-12-13(1), (3), and (14).
44:76:02:22. Heating and cooling. The temperature in any occupied space in the facility shall be maintained between 68 and 80 degrees Fahrenheit during business hours.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
44:76:02:23. Other hazardous conditions. A facility may be directed to remove or correct other hazardous conditions not covered in this chapter if the department considers the conditions to have a potential to cause injury or illness to the patients or staff.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1).
Law Implemented: SDCL 34-12-13(1).
CHAPTER 44:76:03
FIRE PROTECTION
Section
44:76:03:01 Fire safety code requirements.
44:76:03:02 General fire safety.
44:76:03:01. Fire safety code requirements. Each facility shall meet applicable fire safety standards in NFPA 101 Life Safety Code, 2000 edition.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
Reference: NFPA 101 Life Safety Code, 2000 edition, National Fire Protection Association. Copies may be obtained from the National Fire Protection Association, P.O. Box 9101, Quincy, Massachusetts 02269-9101. Phone: 1-800-344-3555. Cost: $93.00.
44:76:03:02. General fire safety. Each facility covered under this article shall be constructed, arranged, equipped, maintained, and operated to avoid undue danger to the lives and safety of its occupants from fire, smoke, fumes, or resulting panic during the period of time reasonably necessary for escape from the structure in case of fire or other emergency. The fire alarm system shall be sounded each month. A minimum of two staff members shall be on duty at all times. In a multilevel facility, at least one staff member shall be on duty on each floor containing occupied beds. Compliance with this section does not eliminate or reduce the necessity for other provisions for safety of persons using the structure under normal occupancy conditions.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
Cross-Reference: Fire safety code requirements, § 44:76:03:01.
CHAPTER 44:76:04
MANAGEMENT AND ADMINISTRATION
Section
44:76:04:01 Administrative management.
44:76:04:02 Governing body.
44:76:04:03 Medical staff.
44:76:04:04 Administrator.
44:76:04:05 Personnel.
44:76:04:06 Personnel training.
44:76:04:07 Employee health program.
44:76:04:08 Admissions of patients.
44:76:04:09 Disease prevention.
44:76:04:10 Tuberculin screening requirements.
44:76:04:11 Care policies.
44:76:04:12 Transfer agreements.
44:76:04:13 Quality assessment.
44:76:04:14 Discharge planning.
44:76:04:01. Administrative management. Each facility shall comply with §§ 44:76:04:02 to 44:76:04:12, inclusive.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:04:02. Governing body. Each facility operated by limited liability partnership, a corporation, or political subdivision shall have an organized governing body legally responsible for the overall conduct of the facility. If the facility is operated by an individual or partnership, the individual or partnership shall carry out the functions in this chapter pertaining to the governing body. The governing body shall establish and maintain administration policies, procedures, or bylaws governing the operation of the facility. The governing body of a facility shall determine which categories of practitioners are eligible candidates for appointment to the medical staff and shall credential and grant admitting or patient care privileges to appointees to the medical staff. The governing body may appoint members to the medical staff only after considering the recommendations of the existing members of the medical staff. In addition, the governing body shall do the following:
(1) Appoint the medical staff and grant privileges in accordance with the bylaws of the medical staff and governing body;
(2) Maintain personnel records on each employee, including job application, professional licensing information, and health information;
(3) Establish procedures for transfer to a hospital of patients requiring immediate medical care beyond the capacity of the ambulatory surgery center;
(4) Assure that all patients admitted to the ambulatory surgery center are under the care of a physician who is a member of the medical staff;
(5) Assure the provision of equipment is in good repair within the ambulatory surgery center to provide efficient services and protection to the patients and staff;
(6) Provide for the patient all essential medical information, including diagnosis, if a patient is transferred to another health care facility; and
(7) Provide a written plan for the evacuation of patients, visitors, and personnel in the event of fire or other disaster within the ambulatory surgery center and an alarm system to notify personnel. Personnel shall be acquainted with the evacuation plan.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
Cross-Reference: Medical staff, § 44:76:04:03.
44:76:04:03. Medical staff. A facility shall have a medical staff organized under bylaws and rules approved by the governing body and responsible to the governing body for the quality of all medical care provided patients in the facility and for the ethical and professional practices of its members. The medical staff shall include physicians, but it may also include other practitioners appointed by the governing body. If the medical staff has an executive committee, a majority of the members of the committee shall be physicians. The responsibility for the conduct of medical staff affairs shall be assigned to an individual physician. The medical staff shall establish a credentials committee to review the qualifications of practitioners applying for admitting or patient care privileges and recommend to the governing body practitioners eligible for appointment to the medical staff by the governing body. The review shall include recommendations regarding delineation of admitting and patient care privileges. The medical staff shall conduct appraisals of its members at least every two years. The review shall include recommendations regarding delineation of privileges. In addition, the medical staff shall do the following:
(1) Hold at least quarterly meetings for which records of attendance and minutes are kept;
(2) At least biennially review and analyze the clinical experience of its members and the medical records of patients on sampling or another basis. All techniques and procedures involving diagnosis and treatment of patients shall be reviewed annually and shall be subject to change by the medical staff;
(3) Assure that all persons admitted to the ambulatory surgery center are under the care of a physician; and
(4) Assure that all medical orders are given by a practitioner and recorded in accordance with the medical staff bylaws and rules. All orders shall be signed or countersigned by the attending physician.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
Cross-Reference: Governing body, § 44:76:04:02.
44:76:04:04. Administrator. The governing body shall designate a qualified administrator to represent the owner or governing body and to be responsible for the daily overall management of the facility. The administrator shall designate a qualified person to represent the administrator during the administrator's absence. The governing body shall notify the department in writing of any change of administrator.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:04:05. Personnel. The facility shall have a sufficient number of qualified personnel to provide effective and safe care. Staff members on duty shall be awake at all times. Any supervisor shall be 18 years of age or older. Written job descriptions and personnel policies and procedures shall be made available to personnel of all departments and services. The facility may not knowingly employ any person with a conviction for abusing another person. The facility shall establish and follow policies regarding special duty or staff members on contract.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:04:06. Personnel training. The facility shall have a formal orientation program and an ongoing education program for all personnel. Ongoing education programs shall cover the required subjects annually. These programs shall include the following subjects:
(1) Fire prevention and response. The facility shall conduct fire drills quarterly for each shift to provide training for all staff;
(2) Emergency procedures and preparedness;
(3) Infection control and prevention;
(4) Accident prevention and safety procedures;
(5) Proper use of restraints;
(6) Patient rights;
(7) Confidentiality of patient information;
(8) Incidents and diseases subject to mandatory reporting and the facility's reporting mechanisms; and
(9) Care of patients with unique needs;
Personnel whom the facility determines will have no contact with patients are exempt from training required by subdivisions (5) and (9) of this section.
Additional personnel education shall be based on facility identified needs.
Current professional and technical reference books and periodicals shall be made available for personnel.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:04:07. Employee health program. The facility shall have an employee health program for the protection of the patients. All personnel shall be evaluated by a licensed health professional for freedom from reportable communicable disease which poses a threat to others before assignment to duties or within 14 days after employment including an assessment of previous vaccinations and a tuberculin skin tests or blood assay test. The facility may not allow anyone with a communicable disease, during the period of communicability, to work in a capacity that would allow spread of the disease. Any personnel absent from duty because of a reportable communicable disease which may endanger the health of patients and fellow employees may not return to duty until they are determined by a physician, physician’s designee, physician assistant, nurse practitioner, or clinical nurse specialist to no longer have the disease in a communicable stage.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (5), and (14).
Law Implemented: SDCL 34-12-13(1), (5), and (14).
Cross-Reference: Reportable diseases, ch 44:20:01.
44:76:04:08. Admissions of patients. The governing body of the facility shall establish and maintain admission, assessment, transfer, and discharge policies, with written evidence to assure the patients admitted are within the licensure classification of the facility or its distinct part. The facility may admit, on the orders of a practitioner, only those patients for whom it can provide care safely and effectively.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:04:09. Disease prevention. Each facility shall provide an organized infection control program for preventing, investigating and controlling infection. The facility shall establish written policies regarding visitation in the various services and departments of the facility. Any visitor who has an infectious disease, who has recently recovered from such a disease, or who has recently had contact with such a disease shall be discouraged from entering the facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (5), and (14).
Law Implemented: SDCL 34-12-13(1), (5), and (14).
44:76:04:10. Tuberculin screening requirements. Each facility shall develop criteria to screen healthcare workers for Mycobacterium tuberculosis (TB) based on the guidelines issued by Centers for Disease Control and Prevention. Each facility shall establish policies and procedures for conducting Mycobacterium tuberculosis risk assessment that include the key components of responsibility, surveillance, containment, and education. The frequency of repeat screening shall depend upon annual risk assessments conducted by the facility.
Tuberculin screening requirements for healthcare workers are as follows:
(1) Each new healthcare worker shall receive the two-step method of tuberculin skin test or a TB blood assay test to establish a baseline within 14 days of employment. Any two documented tuberculin skin tests completed within a 12 month period prior to the date of employment can be considered a two-step or one blood assay TB test completed within a 12 month period prior to the date of employment can be considered an adequate baseline test. Skin testing or TB blood assay tests are not necessary if a new employee transfers from one licensed healthcare facility to another licensed healthcare facility within the state if the facility received documentation of the last skin testing completed within the prior 12 months. Skin testing or TB blood assay test are not necessary if documentation is provided of a previous positive reaction to either test. Any new healthcare worker who has a newly recognized positive reaction to the skin test or TB blood assay test shall have a medical evaluation and a chest X-ray to determine the presence or absence of the active disease;
(2) A new healthcare worker who provides documentation of a positive reaction to the tuberculin skin test or TB blood assay test shall have a medical evaluation and chest X-ray to determine the presence or absence of the active disease; and
(3) Each healthcare worker with a history of a positive reaction to the tuberculin skin test or blood assay shall be evaluated annually by a physician, physician assistant, nurse practitioner, clinical nurse specialist, or a nurse and a record maintained of the presence or absence of symptoms of Mycobacterium tuberculosis. If this evaluation results in suspicion of active tuberculosis, the person shall be referred for further medical evaluation to confirm the presence or absence of tuberculosis.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (5), and (14), 34-22-9.
Law Implemented: SDCL 34-12-13(1), (5), and (14).
Reference: Reference: Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health-Care Facilities, 2005. "Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report," December 30, 2005 (RR17).
44:76:04:11. Care policies. Each facility shall establish and maintain policies, procedures, and practices that follow accepted standards of professional practice to govern care, and related medical or other services necessary to meet the patients' needs.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:04:12. Transfer agreements. Each ambulatory surgery center shall have in effect a transfer agreement with one or more hospitals to provide services not available on site. The agreement shall provide for an interchange of medical and other necessary information. The facility shall have an effective procedure for the immediate transfer to a hospital of patients requiring emergency medical care beyond the capabilities of the facility. The hospital shall be a local Medicare participating or local nonparticipating hospital that meets the requirements for payment for emergency services. The facility shall have a written transfer agreement with a hospital or all physicians performing surgery in the facility have admitting privileges at a hospital.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5).
Law Implemented: SDCL 34-12-13(5).
44:76:04:13. Quality assessment. Each licensed facility shall provide for on-going evaluation of the quality of services provided to patients that includes any contract services. Components of the quality assessment evaluation shall include establishment of facility standards; interdisciplinary review of patient services to identify deviations from the standards and actions taken to correct deviations; patient satisfaction surveys; utilization of services provided; and documentation of the evaluation and report to the governing body.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5) and (14).
Law Implemented: SDCL 34-12-13(5) and (14).
44:76:04:14. Discharge planning. A facility shall have policies and procedures for discharge planning including the person responsible, members of the discharge planning team, a list of all area agencies and resources, and a description of the process. Outside caregivers may be included in discharge planning conferences.
The facility shall initiate planning with applicable agencies to meet identified needs, and patients shall be offered assistance to obtain needed services upon discharge. Information necessary for coordination and continuity of care shall be made available to whomever the patient is discharged and to referral agencies as required by the discharge plan.
The facility shall ensure each has a discharge order signed by the physician who performed the surgery or procedure. All patients shall be discharged in the company of a responsible adult, except those patients exempted by the attending physician as outlined by the facility policy. Each patient shall be provided written discharge instructions.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(5) and (14).
Law Implemented: SDCL 34-12-13(5) and (14).
CHAPTER 44:76:05
PHYSICIAN SERVICES
Section
44:76:05:01 Admissions.
44:76:05:02 Medical orders.
44:76:05:03 Physician assistant, nurse practitioner, or clinical nurse specialist.
44:76:05:01. Admissions. Each patient may be admitted only on the order of a practitioner, and the patient's health care shall continue under the supervision of a physician who is a member of the medical staff. Before or on admission of a patient, the patient's physician shall provide the staff of the facility with documented information regarding current medical findings, admitting diagnoses, and written orders for the immediate care of the individual.
The facility shall develop and maintain a policy that identifies patients who require a medical history and physical examination prior to surgery. The policy must:
(1) Include the timeframe for a medical history and physical examination to be completed prior to surgery;
(2) Address:
(A) Patient age;
(B) Diagnosis;
(C) Type and number of procedures scheduled to be performed on the same surgery date;
(D) Known comorbidities; and
(E) Planned anesthesia level; and
(3) Be based on any applicable nationally recognized standards of practice and guidance, and any applicable state and local health and safety laws.
The history and physical examination shall be completed and placed in the patient's medical record prior to surgery except in emergency situations. In emergency situations when a history and physical examination cannot be completed prior to surgery, a brief admission note on the patient record is necessary. The note must include pulmonary status, cardiovascular status, blood pressure, and vital signs. The history and physical examination shall state the patient and anesthesia choice is appropriate for the facility setting.
Source: 42 SDR 51, effective October 13, 2015; 48 SDR 59, effective December 5, 2021.
General Authority: SDCL 34-12-13(6).
Law Implemented: SDCL 34-12-13.
44:76:05:02. Medical orders. All medical orders, including verbal orders, shall be in writing or electronic format and shall be dated, timed, and authenticated promptly by the practitioner. Verbal orders are for medications, treatments, interventions, or other patient care that are transmitted as oral, spoken communications between senders and receivers, delivered either face-to-face or via telephone. Verbal orders may be taken only when there is an urgent need to initiate or change a medical order. The practitioner shall time, date, and authenticate the orders for all patients promptly. Each practitioner is responsible for documenting written or electronic orders and progress notes on each patient's medical record.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(6).
Law Implemented: SDCL 34-12-13(6).
44:76:05:03. Physician assistant, nurse practitioner, or clinical nurse specialist. If the services of a physician assistant, nurse practitioner, or clinical nurse specialist are utilized, the facility shall develop written policies regarding their role in the care of the patient.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(6).
Law Implemented: SDCL 34-12-13(6).
CHAPTER 44:76:06
NURSING AND RELATED CARE SERVICES
Section
44:76:06:01 Nursing services.
44:76:06:02 Nursing policies and procedures.
44:76:06:01. Nursing services. Each facility shall have an organized nursing service under the direction of a registered nurse. At least one registered nurse shall be on duty in the ambulatory surgery center at all times when a patient is in the facility. Written policies and procedures consistent with the standards of nursing practices shall be developed for the direction and guidance of nursing personnel. All licensed practical nurses and other nursing personnel involved in patient care shall be under the direct supervision of a registered nurse. When a general anesthetic is used, at least one registered nurse other than the individual administering anesthesia shall be available in each operating room during surgical procedures. Nursing personnel shall be familiar with the location and trained in the operation and use of emergency and resuscitative equipment. A facility shall maintain a sufficient number of nursing personnel on duty at all times to provide supervision of and nursing care for all patients. An unlicensed employee of a licensed facility may not accept any delegated skilled tasks from any nonemployed, noncontracted skilled nursing and therapy providers pursuant to SDCL chapters 36-9, 36-10, and 36-31. The perioperative registered nurse monitoring the patient receiving moderate sedation or analgesic shall have no other responsibilities that would require leaving the patient unattended or compromise continuous monitoring during the procedure. The perioperative registered nurse shall continuously monitor the patient's heart rate and function via electrocardiogram; oxygenation using pulse oximetry; respiratory rate and adequacy of ventilation, blood pressure; level of consciousness, comfort level, and skin condition at regular intervals. Annually education and competency shall be completed for nursing staff responsible for moderate sedation.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(7).
Law Implemented: SDCL 34-12-13(7).
Cross-Reference: Scope and standards of nursing practice -- Basic role, § 20:48:04:01.
44:76:06:02. Nursing policies and procedures. The facility shall establish and maintain policies and procedures that provide the nursing staff with methods of meeting its administrative and technical responsibilities in providing care to patients. The policies shall include at least the following:
(1) The noting of diagnostic and therapeutic orders;
(2) Assigning the nursing care of patients;
(3) Administration and control of medications;
(4) Charting by nursing personnel;
(5) Infection control;
(6) Patient safety; and
(7) Delineation of orders from nonphysician practitioners.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(7).
Law Implemented: SDCL 34-12-13(7).
CHAPTER 44:76:07
MEDICATION CONTROL
Section
44:76:07:01 Pharmaceutical services.
44:76:07:02 Policies and procedures.
44:76:07:03 Written orders for medication required.
44:76:07:04 Storage and labeling of medications and drugs.
44:76:07:05 Control and accountability of medications and drugs.
44:76:07:06 Documentation of drug disposal.
44:76:07:07 Medication administration.
44:76:07:08 Medication records.
44:76:07:09 Administration of facility pharmacy.
44:76:07:01. Pharmaceutical services. The requirements for pharmaceutical services in ambulatory surgery centers are as follows:
(1) A physician, pharmacist, or registered nurse is responsible for the supervision of drug stocks in the facility;
(2) Records shall be kept of stock supplies of all drugs and shall give an accounting for all items purchased and dispensed;
(3) Policies and procedures on drug handling, storing, labeling, and dispensing shall be in writing and available to personnel; and
(4) All drugs in the facility shall be labeled with drug name, strength, and expiration date and shall be stored in specially designated, well illuminated cabinets, closets, or storerooms. Drug cabinets shall be accessible only to authorized individuals as outlined in the facilities policies and procedures. All drugs controlled pursuant to SDCL chapter 34-20B shall be securely locked and shall be accessible only to authorized individuals.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:02. Policies and procedures. Each facility shall establish and practice methods and procedures for medication control that include the following:
(1) A requirement that each patient's prescribing physician, physician assistant, or nurse practitioner provide to the facility electronic or written signed orders for any medications taken by the patient; authorization for medications or drugs kept on the person or in the room of the patient; and release of medications;
(2) Provisions for proper storage of prescribed medications so that the medications are inaccessible to patients or visitors with requirements for:
(a) Separate storage of poisons, topical medications, and oral medications;
(b) Each patient's medication to be stored in the container in which it was originally received and not transferred to another container; and
(c) A medication prescribed for one patient not to be administered to any other patient;
(3) Self-administration of medications to be accomplished with the supervision and within the scope of practice by a designated employee of the facility to include:
(a) A description of the responsibilities of the patient, the patient's family members, and the facility staff; and
(b) The provision of written educational material explaining to the patient and the patient's family the patient's rights and responsibilities associated with self-administration; and
(4) The proper disposition of medicines that are discontinued because of the discharge or death of the patient, because the drug is outdated, or because the prescription is no longer appropriate to the care of the patient.
Methods and written policies and procedures shall be established to include the manner of issuance, proper storage, control, accountability, and administration of medications or drugs in accordance with pharmaceutical and nursing practices as well as professional standards.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:03. Written orders for medication required. All medications or drugs administered to patients shall be ordered electronically or in writing and authenticated by the prescriber. Verbal orders for medications or drugs may be taken only when there is an urgent need to initiate or change an order and accepted only by a pharmacist or licensed nurse in facility. The prescriber shall date, time, and authenticate the orders for patients promptly. The practitioner shall date, time, and authenticate the orders for patients as soon as promptly. A policy on stop orders for antibiotics, anticoagulants, and controlled drugs shall be established based on recommendations of the medical staff.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:04. Storage and labeling of medications and drugs. All drugs or medications shall be stored in a well illuminated, locked storage area that is well ventilated, maintained at a temperature appropriate for drug storage, and inaccessible to patients, or visitors at all times. Medications suitable for storage at room temperature shall be maintained between 59 and 86 degrees Fahrenheit (15 and 30 degrees centigrade). Medications that require refrigeration shall be maintained between 36 and 46 degrees Fahrenheit (2 and 8 degrees centigrade). Poisons and medications prescribed for external use shall be stored separately from internal medications, locked and made inaccessible to patients.
The medications or drugs of each patient for whom medications are facility-administered shall be stored in the containers in which they were originally received and may not be transferred to another container. Special modification of this requirement may be made if single dose packaging is used. Each prescription drug container, including manufacturer's complimentary samples, shall be labeled with the patient's name, physician, physician assistant, or nurse practitioner's name, drug name and strength, directions for use, and prescription date.
Containers with contents that will not be used within 30 days of issue or with contents that expire in less than 30 days of issue shall bear an expiration date. If a single dose system is used, the drug name and strength, expiration date, and a control number shall be on the unit dose packet.
If a stock bottle system is used in a facility with a licensed pharmacy, the container shall be labeled with the drug name and strength, expiration date, and a control number. Any container with a worn, illegible, or missing label shall be destroyed pursuant to § 44:73:08:06. Licensed pharmacists are responsible for the labeling, relabeling, or altering of labels on medication containers.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:05. Control and accountability of medications and drugs. A patient may self-administer medications brought from home during their treatment or these medications may be administered by the facility staff if ordered by the attending physician, physician assistant, or nurse practitioner and, if prior to administration, is identified as the prescribed drug. Medications prescribed for one patient may not be administered to another. Patients may not keep medications on their person without a physician's, physician assistant, or nurse practitioner's order allowing self-administration. Written authorization by the patient's physician, physician assistant, or nurse practitioner shall be secured for the release of any medication to a patient upon discharge from the facility. The release of medication shall be documented in the patient's record, indicating quantity, drug name, and strength. The facility shall maintain records that account for all medications and drugs from their receipt through administration, destruction, or return.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:06. Documentation of drug disposal. Legend drugs not controlled under SDCL chapter 34-20B shall be destroyed or disposed of by a nurse and another witness. Destruction or disposal of medications controlled under SDCL chapter 34-20B shall be witnessed by two persons, both of whom are a nurse or pharmacist, as designated by facility policy. Methods of destruction or disposal may include:
(1) Disposal by using a professional waste hauler to take the medications to a permitted medical waste facility or by facility disposal at a permitted municipal solid waste landfill. Prior to disposal all medications shall be removed from original containers and made unpalatable by the addition of adulterants and alteration of solid dosage forms by dissolving or combination into a solid mass;
(2) Return to the dispensing pharmacy for destruction or dispose according to federal and state regulations;
(3) Return to an authorized reverse distributor company licensed by the South Dakota Board of Pharmacy; or
(4) Release to patient upon discharge after authorization by the patient's prescribing practitioner.
Documentation of destruction or disposal of medications shall be included in the patient's record. The documentation shall include the method of disposition (destruction, disposal, return to pharmacy, or release to patient); the medication name, strength, prescription number (as applicable), quantity, and date of disposition; and the name of any person who witnessed the destruction or disposal.
Medications, excluding those controlled under SDCL chapter 34-20B, contained in unit dose packaging meeting the requirements of § 20:51:13:02.01 may be returned to the dispensing pharmacy for credit and redispensing.
Any medication held for disposal shall be physically separated from the medications being used in the facility, locked with access limited, in an area with a system to reconcile, audit, or monitor them to prevent diversion.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:07. Medication administration. Each medication administered shall be recorded in the patient's medical record and signed by the person responsible. Medication errors and drug reactions shall be reported to the patient's physician, physician assistant, or nurse practitioner and an entry made in the patient's medical record. Orders involving abbreviations and chemical symbols may be carried out only if the facility has a standard list of abbreviations and symbols approved by the medical staff or, in the absence of an organized medical staff, by the medical director and the list is available to the nursing staff. All medications shall be administered to patients by personnel acting under delegation of a licensed nurse, or licensed to administer medications.
A person may not administer medications that have been prepared by another person, other than a pharmacist.
Medication administration shall comply with §§ 44:76:08:02 to 44:76:08:05, inclusive, and with the requirements for training in §§ 20:48:04.01:14 and 20:48:04.01:15 and for supervision in § 20:48:04.01:02. The supervising nurse shall provide an orientation to the unlicensed assistive personnel who will administer medications. The orientation shall be specific to the facility and relevant to the patients receiving administered medications.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:08. Medication records. Medication administration records shall be used and regularly checked against the practitioner's orders. Each medication administered shall be recorded in the patient's medical record and signed by the individual responsible.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
44:76:07:09. Administration of facility pharmacy. The pharmaceutical service of each facility with a licensed full or part-time pharmacy shall be directed by a licensed pharmacist accountable to the administration of the facility. Only prepackaged drugs or a single dose unit may be removed from the pharmacy when the pharmacist is not available. These drugs may be removed only by a designated registered nurse or physician, physician assistant, or nurse practitioner in amounts sufficient only for immediate therapeutic needs. A record of such withdrawals shall be made by the designated nurse or the physician, physician assistant, or nurse practitioner making the withdrawal.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(9).
Law Implemented: SDCL 34-12-13(9).
CHAPTER 44:76:08
MEDICAL RECORD SERVICES
Section
44:76:08:01 Medical record department.
44:76:08:02 Medical record department staff.
44:76:08:03 Written policies and confidentiality of records.
44:76:08:04 Record content.
44:76:08:05 Authentication.
44:76:08:06 Retention of medical records.
44:76:08:07 Storage of medical records.
44:76:08:08 Destruction of medical records.
44:76:08:09 Disposition of medical records on closure of facility or transfer of ownership.
44:76:08:01. Medical record department. There shall be an organized medical record system. A medical record shall be maintained for each level of care for each patient admitted to the facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
44:76:08:02. Medical record department staff. The medical record functions shall be performed by persons trained and equipped to facilitate the accurate processing, checking, indexing, filing, and retrieval of all medical records. The individual responsible for the medical records service shall have knowledge and training in the field of medical records.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
44:76:08:03. Written policies and confidentiality of records. There shall be written policies and procedures to govern the administration and activities of the medical record service. They shall include policies and procedures pertaining to the confidentiality and safeguarding of medical records, the record content, continuity of a patient's medical records during subsequent admissions, requirements for completion of the record, and the entries to be made by various authorized personnel.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
44:76:08:04. Record content. Each medical record shall show the condition of the patient from the time of admission until discharge and shall include the following:
(1) Identification data;
(2) Consent forms, except in procedures determined emergencies;
(3) History of the patient;
(4) Any allergies and abnormal drug reactions;
(5) Entries related to anesthesia administration;
(6) A current overall plan of care;
(7) Report of the initial and periodic physical examinations, evaluations, and all plans of care with subsequent changes;
(8) Diagnostic and therapeutic orders;
(9) Progress notes from all disciplines;
(10) Laboratory and radiology reports;
(11) Description of treatments, diet, and services provided and medications administered;
(12) All indications of an illness or an injury, including the date, the time, and the action taken regarding each;
(13) An operative report with findings and techniques of the operation that include pre-operative and postoperative diagnosis; and
(14) Discharge diagnosis, including all discharge instructions for home care.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
44:76:08:05. Authentication. A facility shall ensure entries to the medical record timed, dated and signed or electronically authenticated. If the facility permits any portion of the medical record to be generated by electronic or optical means, policies and procedures shall exist to prohibit the use of authentication by unauthorized users.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
44:76:08:06. Retention of medical records. A facility shall retain medical records for a minimum of ten years from the actual visit date of service or patient care. The retention of the record for ten years is not affected by additional and future visit dates. Records of minors shall be retained until the minor reaches the age of majority plus an additional two years, but no less than ten years from the actual visit date of service or patient care. The retention of the record for ten years is not affected by additional and future visit dates.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
Cross-Reference: Storage of medical records, § 44:76:08:07.
44:76:08:07. Storage of medical records. A facility shall provide for filing, safe storage, and easy accessibility of medical records. The medical records shall be preserved as original records or in other readily retrievable and reproducible form. Medical records shall be protected against access by unauthorized individuals. All medical records shall be retained by the health care facility upon change of ownership.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
Cross-Reference: Disposition of medical records on closure of facility or transfer of ownership, § 44:76:08:09.
44:76:08:08. Destruction of medical records. After the minimum retention period of ten years from the actual visit date of care outlined in § 44:76:09:06, the medical record may be destroyed at the discretion of the health care facility. Before the destruction of the medical record, the facility shall prepare and retain a patient index or abstract. The patient index or abstract shall include:
(1) Name;
(2) Medical record number;
(3) Date of birth;
(4) Summary of visit dates;
(5) Attending or admitting physician; and
(6) Diagnosis or diagnosis code.
The facility shall destroy the medical record in a way that maintains confidentiality.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
44:76:08:09. Disposition of medical records on closure of facility or transfer of ownership. If a facility ceases operation, the facility shall provide for safe storage and prompt retrieval of medical records and the patient indexes specified in § 44:76:09:08. The facility may arrange storage of medical records with another facility of the same licensure classification, transfer medical records to another health care provider at the request of the patient, relinquish medical records to the patient's parent or legal guardian, or arrange storage of remaining medical records with a third party vendor who undertakes such a storage activity. At least 30 days before closure, the facility shall notify the department in writing indicating the provisions for the safe preservation of medical records and their location and publish in a local newspaper the location and disposition arrangements of the medical records.
If ownership of the facility is transferred, the new owner shall maintain the medical records as if there was not a change in ownership.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
Cross-Reference: Storage of medical records, § 44:76:08:07.
CHAPTER 44:76:09
DIAGNOSTIC SERVICES
Section
44:76:09:01 Laboratory services.
44:76:09:02 Pathology services.
44:76:09:03 Technical laboratory operations.
44:76:09:04 Blood transfusion services.
44:76:09:05 Diagnostic x-ray services.
44:76:09:06 Radiological service policies and manuals required.
44:76:09:07 Radiological department personnel.
44:76:09:08 Radiological reports.
44:76:09:01. Laboratory services. Laboratory services performed in an ambulatory surgery center shall be under the supervision of a qualified director or shall be done by a laboratory that has a valid Clinical Laboratory Improvement Amendment (CLIA) certificate. Laboratory examinations necessary for diagnosis and treatment of the patient shall be performed in the facility or by arrangement. Laboratory examinations required on facility admissions are determined by the medical staff and bylaws. The original laboratory report shall be made a part of the patient's medical record.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(11).
Law Implemented: SDCL 34-12-13(11).
Note: CLIA applications are obtained from the South Dakota Department of Health, Office of Licensure and Certification, 615 East 4th Street, Pierre, SD 57501. Telephone (605) 773-3356, Division of Laboratory Standards and Performance, Health Standards and Quality Bureau, Centers for Medicare/Medicaid Services, 7500 Security Boulevard S-2-11-07, Baltimore, MD 21244-1850. Telephone (410)-786-3531, or online at www.phppo.cdc.gov/clia/default.osp.
44:76:09:02. Pathology services. Each laboratory shall have the services of a pathologist available within the facility or by arrangement. Any tissue removed from a patient shall be handled as outlined in facility policy. Pathology services by arrangement shall be governed by written policies and procedures establishing guidelines for the prompt transportation of specimens and submission of reports.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(11).
Law Implemented: SDCL 34-12-13(11).
44:76:09:03. Technical laboratory operations. Each laboratory shall have a policy and procedural manual for each phase of operation. There shall be a quality control program to insure the reliability of laboratory test data. Each item of diagnostic test equipment shall be routinely checked and shall be precise in terms of calibration as shown by records maintained in the laboratory.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(11).
Law Implemented: SDCL 34-12-13(11).
44:76:09:04. Blood transfusion services. Each facility providing transfusion services shall provide facilities and equipment for the procurement, storage, and administration of blood products. Blood, blood products, and equipment required for their administration shall be provided to meet the needs of the patients. The transfusion service shall be under the supervision of the medical staff. There shall be written policies and procedures regarding administration of blood products, as well as the investigation of possible transfusion reactions.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(11).
Law Implemented: SDCL 34-12-13(11).
44:76:09:05. Diagnostic x-ray services. Each facility shall be able to provide or arrange with an outside service for the provision of diagnostic radiology services in connection with surgery to be performed. Safety and sanitation procedures as required by the department for the radiological service which will protect the patient and the radiological worker shall be established and enforced. There shall be a quality control program with records maintained in the facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(11).
Law Implemented: SDCL 34-12-13(11).
Cross-Reference: Radiation safety, art 44:03.
44:76:09:06. Radiological service policies and manuals required. There shall be a policy and procedural manual for all phases of the radiological services. If radioactive isotopes are to be used within the facility, policies which are approved by the medical staff shall be established.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(11).
Law Implemented: SDCL 34-12-13(11).
44:76:09:07. Radiological department personnel. There shall be trained personnel to provide the scope of services offered by the facility. If therapeutic radiological services are provided, the services shall be under the direct supervision of a radiologist.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(11).
Law Implemented: SDCL 34-12-13(11).
44:76:09:08. Radiological reports. Complete signed reports of the interpretations of all radiological examinations made by practitioners shall be made a part of the patient's clinical record. The radiological department shall have a policy that requires any record to be retained for at least ten years and any film to be retained for at least five years.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10).
Law Implemented: SDCL 34-12-13(10).
CHAPTER 44:76:10
SURGICAL SERVICES
Section
44:76:10:01 Scope of surgical services.
44:76:10:02 Surgical services.
44:76:10:03 Surgical records.
44:76:10:04 Anesthesia services.
44:76:10:05 Emergency equipment.
44:76:10:06 Emergency services.
44:76:10:01. Scope of surgical services. The ambulatory surgery center services are limited to those surgical and other medical procedures that may be safely performed in a dedicated operating room or procedure rooms and which may require a postoperative recovery room or short-term, not overnight, convalescent room. An ambulatory surgery center may not retain patients overnight. Surgical procedures which may not be performed in an ambulatory surgery center includes those that:
(1) Generally result in extensive blood loss;
(2) Require major or prolonged invasion of body cavities;
(3) Directly involve major blood vessels;
(4) Are generally emergent or life-threatening in nature; or
(5) Require admission to a hospital on an inpatient basis in order to have the procedure performed or to recover from the procedure.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:10:02. Surgical services. Each facility in which surgery is performed shall maintain an operating suite with appropriate equipment, including an X-ray view box or film illuminator. The suite shall be supervised by a registered nurse with training and experience in operating room services. A circulating nurse shall be assigned to each operating or procedure room during each procedure and shall be present for the duration of the surgical procedure unless it becomes necessary for the nurse to leave the operating or procedure room as part of the procedure or the nurse is relieved by another circulating nurse. There shall be written policies for surgical services which govern surgical staff privileges, supportive services of other professional and paramedical personnel, and operating suite procedures. Policies and procedures pertaining to safety controls shall be developed and implemented. Safety controls shall be posted. A roster of surgical staff members which delineates the surgical privileges of each member shall be maintained on file in the operating suite.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(12).
Law Implemented: SDCL 34-12-13(12).
44:76:10:03. Surgical records. When surgery is performed, the following record requirements apply:
(1) An operating room register shall be maintained and shall include the patient's name, identification number or medical record number, date of operation, inclusive or total time of the operation or procedure, name of surgeon and all assistants, nursing personnel, type of anesthesia and name of person administering, operation or procedure performed, preoperative and postoperative diagnosis, and age of patient;
(2) The patient's medical record, including at least a medical history, a copy of the physician's examination, copies of laboratory tests, radiology reports, a signed consent for the surgical procedure to be performed, and a preoperative diagnosis, shall be made available in the surgical suite at the time of surgery; and
(3) An accurate and complete description of the operative procedure that includes a preoperative and postoperative diagnosis shall be recorded by the operating surgeon within 48 hours following completion of surgery.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(10) and (12).
Law Implemented: SDCL 34-12-13(10) and (12).
44:76:10:04. Anesthesia services. Each facility shall provide anesthesia services organized, directed, and integrated with other related services commensurate with the scope and needs of patients. Each facility shall ensure qualified staff deliver anesthesia care to patients according to written policies relating to anesthesia procedures approved by the medical staff. Each facility shall establish safety and sanitation controls. All anesthetizing locations that are not protected against potential explosive hazards shall have a legible sign posted prohibiting the use of flammable gas as anesthetics. At a minimum, a facility shall ensure that:
(1) A physician is on the premises during the post-anesthetic recovery period until all patients are alert or discharged;
(2) When a general anesthetic is used, at least one registered nurse is in the recovery room during the patient's post-anesthetic recovery period;
(3) Policies and procedures on the administration of anesthetics are developed by the medical staff and approved by the governing body;
(4) Prior to undergoing general anesthesia, a patient has a history and physical examination by a physician, including necessary laboratory examinations;
(5) Before discharge from the facility, each patient is evaluated by a physician for proper anesthesia recovery;
(6) No flammable anesthetic is allowed at the facility; and
(7) All anesthetics are administered by an anesthesiologist or anesthetist, except for local anesthetic agents which may be administered by the attending physician.
Source: 42 SDR 51, effective October 13, 2015; 48 SDR 59, effective December 5, 2021.
General Authority: SDCL 34-12-13(6) and (7).
Law Implemented: SDCL 34-12-13(6) and (7).
44:76:10:05. Emergency equipment. The facility governing body and medical staff shall coordinate, develop, and revise policies and procedures to specify the type of emergency equipment required for use in the facilities operating and procedure rooms. The emergency equipment shall meet the following requirements;
(1) Be immediately available for use during emergency situations;
(2) Be appropriate for the facility’s patient population; and
(3) Be maintained by appropriate personnel.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(12).
Law Implemented: SDCL 34-12-13(12).
44:76:10:06. Emergency services. A facility referring patients for transfer must initiate essential life-saving measures and provide emergency procedures within the capacity of the facility that will minimize aggravation of a patient’s condition during transfer. The medical staff shall determine appropriate personnel, equipment, drugs, and supplies for emergency care and shall maintain them readily available.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(12).
Law Implemented: SDCL 34-12-13(12).
CHAPTER 44:76:11
CONSTRUCTION STANDARDS
Section
44:76:11:01 Application of chapter.
44:76:11:02 Administration department.
44:76:11:03. Medical records unit.
44:76:11:04. Storage rooms.
44:76:11:05 Service area in care units.
44:76:11:06 Dietary department.
44:76:11:07 Food preparation services and equipment.
44:76:11:08 Laundry.
44:76:11:09 Employee facilities.
44:76:11:10 Corridor restrictions.
44:76:11:11 Doors.
44:76:11:12 X ray protection.
44:76:11:13 Ceiling heights.
44:76:11:14 Insulation.
44:76:11:15 Floor surface finish.
44:76:11:16 Wall and ceiling finish.
44:76:11:17 Elevators.
44:76:11:18 Steam and hot water systems.
44:76:11:19 Ventilating systems.
44:76:11:20 Filters.
44:76:11:21 Ducts.
44:76:11:22 Food service ventilation.
44:76:11:23 Plumbing fixtures.
44:76:11:24 Water supply systems.
44:76:11:25 Vacuum breakers.
44:76:11:26 Hot water systems.
44:76:11:27 Drainage systems.
44:76:11:28 Electrical distribution system.
44:76:11:29 Lighting.
44:76:11:30 Receptacles or convenience outlets.
44:76:11:31 Staff call system.
44:76:11:32 Submittal of plans and specifications.
44:76:11:33 Pipe requirements.
44:76:11:34 Detached structures.
44:76:11:01. Application of chapter. The provisions of this chapter apply to any new facility and to any renovation, addition, or change in space use of any currently approved existing facility. Accessible and usable accommodations shall be available to the public, staff, and patients with disabilities.
Each facility shall comply with NFPA 101 Life Safety Code, 2012 edition.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
References: NFPA 101 Life Safety Code, 2012 edition, National Fire Protection Association. Copies may be obtained from the National Fire Protection Association, P.O. Box 9101, Quincy, MA 02269-9101. Phone: 1-800-344-3555. Cost: $93.00.
44:76:11:02. Administration department. The administration department shall include a business office, information center, administrator's office, admitting office, staff lounge, medical library, lobby, and public and staff toilet rooms. There shall be space for in-service training.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3) and (4).
Law Implemented: SDCL 34-12-13(3) and (4).
44:76:11:03. Medical records unit. The medical records unit shall include an active record storage area; record review and dictating area; work area for sorting, recording, or microfilming; and an inactive record storage area which may be omitted if microfilming or electronic medical records are used.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3) and (10).
Law Implemented: SDCL 34-12-13(3) and (10).
44:76:11:04. Storage rooms. There shall be at least 20 square feet (1.858 square meters) of central storage provided for each operating or procedure room. General storage shall be concentrated in one area in the facility, but up to 50 percent of the general storage space may be provided on the premises. Each patient shall be provided with closet or locker to secure personal belongings.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
44:76:11:05. Service area in care units. Each care unit shall contain a service area which includes the following:
(1) Staff station with convenient access to handwashing facilities;
(2) Staff charting;
(3) Communications;
(4) Storage for supplies and personal effects;
(5) Staff toilet room;
(6) Nurses' office;
(7) Clean workroom for the storage and assembly of supplies for nursing procedures which contains a work counter and sink;
(8) Soiled workroom which contains a work counter with a handwashing facility, a waste receptacle, soiled linen receptacles, a clinical sink with an exposed water trap seal, siphon jet or blowout action, and a bedpan flushing device;
(9) Medicine room adjacent to the staff station with a sink, refrigerator, locked storage, and facilities for preparation and administration of medication;
(10) Clean linen storage area in an enclosed storage space;
(11) Nourishment station containing refrigerated storage, self-dispensing ice machine, and a sink for serving between-meal nourishments;
(12) Equipment storage room on each patient wing or floor for storage of patient care equipment;
(13) Janitor's closet for storage of housekeeping supplies and equipment which contains a floor receptor or service sink. The janitor's closet space and equipment may be incorporated into the soiled utility room;
(14) Multipurpose rooms for staff, patients, and patients' families for conferences, reports, education, training sessions, and consultation; and
(15) Preoperative and postoperative holding rooms or spaces.
Any modification to the standard may be made. A modification shall be requested in writing by the facility and approved by the department.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-1-17, 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:11:06. Dietary department. Construction, equipment, and installation of the dietary department if provided shall comply with or exceed the minimum standards in §§ 44:02:07:01, 44:02:07:02, and 44:02:07:04 to 44:02:07:95, inclusive, the Food Service Code. The installation shall comply with § 44:76:11:07 unless a commercially prepared dietary service, meals, or disposables are used. If a commercial service is used, dietary areas and equipment shall meet the requirements for sanitary storage, processing, and handling.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
Note: Article 44:02, Lodging and Food Service, Administrative Rules of South Dakota, contains the Food Service Code and may be obtained from Legislative Mail, 1320 East Sioux Avenue, Pierre, South Dakota 57501, telephone (605) 773-4935, for $4.14.
44:76:11:07. Food preparation services and equipment. Any dietary area shall be completely cleanable by conventional methods. The location and design of the dietary area if provided shall enable convenient handling of incoming supplies, preparation of meals, including tray service, and disposal of rubbish and garbage. If a dietary area is provided it shall contain equipment and space provided shall include the following:
(1) A dishwashing area including a commercial dishwasher supplied with 180 degree Fahrenheit (82 degrees centigrade) rinse water or a chemical sanitizing cycle, a garbage disposal, a garbage can, a clean dish table, and handwashing facilities;
(2) Aisles within the dietary area not less than three feet (0.91 meters) wide. Aisles adjoining equipment locations with doors or aisles utilized for cart traffic shall be at least four feet (1.22 meters) wide;
(3) Pot and pan washing facilities, including a three-compartment sink with 18 inch drainboards on both sides and drying and storage facilities for pots and pans;
(4) A vegetable preparation area with a two-compartment sink with drainboards on both sides;
(5) Cart storage areas;
(6) Waste disposal facilities;
(7) Employee dining facilities;
(8) Janitor's closet with storage for housekeeping supplies and equipment and floor receptor or service sink;
(9) Food production equipment sized and designed to prepare a complete meal for the patients, staff, and guests;
(10) Food holding and transportation equipment capable of protecting food from contamination and of maintaining cold food at 41 degrees Fahrenheit (five degrees centigrade) or below and hot food at 135 degrees Fahrenheit (57.2 degrees centigrade) or above during the total serving period;
(11) Ventilation equipment sized and designed to effectively remove steam, heat, cooking vapors, and grease from food production areas, dishwashing areas, and serving areas;
(12) Handwashing facilities that are convenient to each work area, consisting of hot and cold running water, towel dispenser with single-service towels or hand drying device and wall mounted hand cleanser;
(13) In dietary areas shall have a bin or self-dispensing ice maker. Any ice maker accessible to patients or visitors shall be self-dispensing.
Any modification to the standard may be made. A modification shall be requested in writing by the facility and approved by the department.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (2), and (14).
Law Implemented: SDCL 34-12-13(1), (2), and (14).
44:76:11:08. Laundry. The laundry shall include the following:
(1) Linen cart storage;
(2) Storage for laundry supplies;
(3) A lavatory conveniently accessible to soiled, clean, and processing rooms; and
(4) Laundry processing room with separate soiled and clean work areas with commercial equipment. Each clothes dryer shall have a galvanized metal vent pipe for exhaust: and
The space and equipment layout shall be sized and designed to produce quality linen with a work flow that minimizes potential for cross-contamination of clean linen by soiled linen, contaminated equipment, contaminated air, or splash. Any modification to the standard may be made if the services are contracted to an outside organization. A modification shall be requested in writing by the facility and approved by the department.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (4).
Law Implemented: SDCL 34-12-13(1) and (4).
44:76:11:09. Employee facilities. The male and female locker rooms for employees shall have lockers and a separate toilet room with handwashing facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
44:76:11:10. Corridor restrictions. Drinking fountains, telephone booths, fire extinguisher cabinets, and vending machines shall be located so that they do not project into the required width of exit corridors. Handrails installed in corridors shall return to the wall at the ends. Handrails if installed shall be installed with the top 34 to 38 inches, inclusive, from the floor. Handrails shall be installed with one and one half inch spacing between the wall and the handrail.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:11:11. Doors. Any door to a patient toilet shall be equipped with hardware that permits access in any emergency. A pocket or sliding door may not be installed except on a clothes closet or restroom in a patient room. Any hardware on a restroom pocket or sliding door shall provide for ease of operation for a patient with limited mobility. Any door opening onto a corridor, except an elevator door, shall be hinged on the side. An alcove or similar space which generally does not require doors are excluded from this requirement. No door may swing into the corridor except a closet door. Thresholds and expansion joint covers, if used, shall be flush with the floor. Any cross-corridor door shall be provided with vision panels.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:11:12. X ray protection. Protection of X ray and gamma ray installations shall conform to requirements in "Medical X ray, Electron Beam, and Gamma ray Protection for Energies up to 50 MeV--Equipment Design and Use," NCRP Report No. 102, 1989, and in "Structural Shielding Design and Evaluation for Medical Use of X rays and Gamma rays of Energies up to 10 MeV," NCRP Report No. 49, 1976.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (14).
Law Implemented: SDCL 34-12-13(1) and (14).
References: "Medical X ray, Electron Beam, and Gamma ray Protection for Energies up to 50 MeV--Equipment Design and Use," NCRP Report No. 102, National Council on Radiation Protection and Measurements, June 30, 1989. Copies may be obtained from National Council on Radiation Protection and Measurements, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814. Cost: $45.
"Structural Shielding Design and Evaluation for Medical Use of X rays and Gamma rays of Energies up to 10 MeV," NCRP Report No. 49, National Council on Radiation Protection and Measurements, September 15, 1976. Copies may be obtained from National Council on Radiation Protection and Measurements, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814. Cost: $40.
44:76:11:13. Ceiling heights. The ceilings of corridors, storage rooms, patient toilet rooms, and other minor rooms may not be less than seven feet, eight inches (2.34 meters). The ceilings of all other rooms may not be less than seven feet, ten inches (2.39 meters).
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:11:14. Insulation. Boiler rooms, food preparation centers, and laundries shall be insulated and ventilated to prevent any floor surface above them from exceeding a temperature of 85 degrees Fahrenheit (29.4 degrees centigrade). All combustible insulation within the building shall be covered with a fire-resistive material giving fire protection equivalent to one half inch (0.01 meters) gypsum board, unless tested and acceptable by International Building Code, 2012 edition, 2603.4 for use without a thermal barrier as installed.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
Reference: International Building Code, 2012 edition. Copies may be obtained from International Conference of Building Officials, 5360 South Workman Mill Road, Whittier, California 90601-2298. Phone: (562) 699-0541. Cost: $89.00.
44:76:11:15. Floor surface finish. Floors shall be easily cleanable and shall have the wear resistance appropriate for the location involved. Floors in kitchens and related spaces shall be water-resistant. In all areas where floors are subject to wetting, they shall have a nonslip finish. Adjacent dissimilar floor materials shall be flush with each other to provide a level floor surface.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:11:16. Wall and ceiling finish. Walls shall be washable, and in the immediate area of plumbing fixtures the finish shall be protected from water damage. Wall bases in dietary areas shall be free of spaces that can harbor insects. Wall bases in any areas used for surgical procedures shall be integral with either the wall or the floor surface material and shall be without voids that can harbor harmful bacteria. All surgical, X-ray film processing rooms, and dietary ceilings shall be washable or easily cleanable. This requirement does not apply to any boiler room, mechanical and building equipment room, shop, or similar space. A ceiling in any surgical, central sterilization, isolation, and x-ray film processing room shall be epoxy painted gypsum board surface.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:11:17. Elevators. All facilities where either patients' beds or a critical service, such as operating, diagnostic, dietary, laundry, central storage, or therapy rooms, is located, other than the first floor, shall have an electrical or electrohydraulic elevator. Each elevator car and platform shall be constructed of noncombustible material, except that material treated with fire retardant may be used if each exterior surface of the car is covered with metal. A hospital-type elevator shall have inside dimensions that will accommodate a patient's gurney and attendants and shall be at least five feet (1.52 meters) wide by seven feet six inches (2.29 meters) deep. The car door shall have a clear opening of not less than three feet eight inches (1.12 meters). Each elevator shall have automatic two-way leveling with accuracy within plus or minus one half inch (0.01 meters). Elevators, except freight elevators, shall be equipped with a two-way special service switch to permit each car to bypass all landing button calls and to be dispatched directly to any floor.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3) and (4).
Law Implemented: SDCL 34-12-13(3) and (4).
44:76:11:18. Steam and hot water systems. Boilers shall have the capacity to supply the normal requirements of all systems and equipment. Supply and return mains and risers of space heating and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return end. Boilers, smoke breeching, steam supply piping, high pressure steam return piping, and hot water space heating supply and return piping shall be insulated with insulation having a flame spread of 25 or less and a smoke emission rating of 50 or less using NFPA 255, 2006 edition, "Standard Method of Test for Surface Burning Characteristics of Building Materials" or equivalent test procedures.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
Reference: NFPA 255, Reference: NFPA 255, 2006 edition, "Standard Method of Test for Surface Burning Characteristics of Building Materials." Copies may be obtained from National Fire Protection Association, P.O. Box 9101, Quincy, MA 02269-9101. Cost: $35.00.
44:76:11:19. Ventilating systems. The ventilating systems shall maintain temperatures, minimum air changes of outdoor air an hour, minimum total air changes, and relative humidity as follows:
(1) Operating rooms - 68 to 73 degrees Fahrenheit (20 to 22.8 degrees centigrade), three outdoor, 15 total, and 20 to 60 percent humidity;
(2) Recovery rooms - at least 70 degrees Fahrenheit (21.1 degrees centigrade), two outdoor, six total, and 20 to 60 percent humidity;
For all other occupied areas, the facility shall be able to maintain a minimum temperature of 75 degrees Fahrenheit (23.9 degrees centigrade) at winter design conditions with a minimum of at least two total air changes an hour and a relative humidity of 20 percent. All air supply and air exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at the discharge end of the system. Outdoor ventilation air intakes, other than for individual room units, shall be located as far away as practicable but not less than 25 feet (7.62 meters) from plumbing vent stacks and the exhausts from any ventilating system or combustion equipment. The bottom of outdoor intakes serving central air systems shall be located as high as possible but not less than six feet (1.83 meters) above the ground level or, if installed through the roof, three feet (0.91 meters) above roof level. The mechanical ventilation systems shall be designed and balanced to provide make-up air and safe pressure relationships between adjacent areas to preclude the spread of infections and assure the health of the occupants. Room supply air inlets, recirculation, and exhaust air outlets shall be located with the grill or diffuser opening not less than 3 inches (0.08 meters) above the floor. Corridors may not be used to supply air to or exhaust air from any room, except that exhaust air from corridors may be used to ventilate bathrooms, toilet rooms, or janitor's closets opening directly on corridors. Continuous mechanical exhaust ventilation shall be provided in all soiled areas, wet areas, and storage rooms. In unoccupied service areas, ventilation may be reduced or discontinued when the health and comfort of the occupants are not compromised.
Laboratories shall be ventilated at a rate of six total air changes an hour. All ventilation air from the laboratory shall be directly exhausted to the outside. If this ventilation rate does not provide the air required to ventilate fume hoods and safety cabinets, additional air shall be provided. A filter with 90 percent efficiency shall be installed in the air supply system at its entrance to the media transfer room. Hoods in which highly radioactive materials are processed shall have a face velocity of 150 feet a minute (0.76 meters a second), have a high-efficiency (99.97%) filter, and each hood shall have an independent exhaust system with the fan installed at the discharge point of the system. Hoods used for processing infectious materials shall have a face velocity of 75 feet a minute (0.38 meters a second).
Cooking appliances, other than microwave ovens, shall be provided with exhaust ventilation to the exterior of the building to remove cooking odors, heat, and moisture.
Each vehicle parking garage shall be provided with carbon monoxide detection to activate exhaust ventilation of six air changes each hour or to open the garage door if the area of the garage is under 1000 square feet. A sign shall be posted at the front of each parking space advising the driver to shut off the engine.
Crawl spaces shall be provided with mechanical ventilation at least one half air changes each day or be provided with open perimeter venting as required by the International Building Code.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
Reference: International Building Code, 2012 edition. Copies may be obtained from International Conference of Building Officials, 5360 South Workman Mill Road, Whittier, California 90601-2298. Phone: (562) 699-0541. Cost: $89.00.
44:76:11:20. Filters. A ventilation system using a recirculated central air system shall be equipped with a minimum of two filter beds. Filter bed number one shall be located upstream of the conditioning equipment and shall have a minimum efficiency of 30 percent. Each supply air unit shall have a minimum of 30 percent effective filters. Each central ventilation system shall have a minimum of 80 percent effective filters. Each common use area, i.e., dining, lounge, and corridor, shall have 80 percent effective filters on an air supply system. Each air supply system serving solely an administrative area shall have a minimum of 30 percent effective filters. These filter efficiencies shall be warranted by the manufacturer and shall be based on the ASHRAE 52.2, 2007 edition, American Society of Heating, Refrigeration, and Air Conditioning Engineers dust spot test method with atmospheric dust. Each filter frame shall be durable and carefully dimensioned and shall provide an airtight fit with the enclosing duct work. Each joint between filter segments and the enclosing duct work shall be gasketed or sealed to provide a positive seal against air leakage. A manometer shall be installed across each filter bed serving a central air system.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
Reference: ASHRAE 52.2, 2007 edition, American Society of Heating, Refrigeration, and Air Conditioning Engineers. Copies may be obtained from 1791 Tullie Circle, N.E., Atlanta, GA 30329. Phone: 1-800-527-4723. Cost: $39.
44:76:11:21. Ducts. Ducts shall be constructed of iron, steel, aluminum, or other approved metal or materials as defined in NFPA 101 Life Safety Code 2012 edition. Duct linings, coverings, vapor barriers, and the adhesives used for applying them shall have a flame spread classification of not more than 25 and a smoke developed rating of not more than 50 using NFPA 255, 2006 edition, "Standard Method of Test for Surface Burning Characteristics of Building Materials." A fire and smoke damper shall be provided on each opening through each required two-hour or greater fire-resistive wall or floor and on each opening through the walls of a vertical shaft, unless the shaft has a fire and smoke damper at the floor level. Ducts which pass through a required smoke barrier shall be provided with smoke dampers. Access for maintenance shall be provided at all dampers. Duct systems serving hoods shall be constructed of corrosion resistant material. Duct systems serving hoods in which highly radioactive materials and strong oxidizing agents are used shall be constructed of stainless steel for a minimum distance of 10 feet (3.05 meters) from the hood and shall be equipped with wash-down facilities. Cold air ducts shall be insulated wherever necessary to maintain the efficiency of the system or to minimize condensation problems.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
References: NFPA 101 Life Safety Code, 2012 edition, National Fire Protection Association. Copies may be obtained from the National Fire Protection Association, P.O. Box 9101, Quincy, MA 02269-9101. Phone 1-800-344-3555. Cost: $93.00.
NFPA 255, Reference: NFPA 255, 2006 edition, "Standard Method of Test for Surface Burning Characteristics of Building Materials." Copies may be obtained from National Fire Protection Association, P.O. Box 9101, Quincy, MA 02269-9101. Cost: $35.00.
44:76:11:22. Food service ventilation. The air from dining areas may be used to ventilate the food preparation areas only after it has been passed through a filter with 80 percent efficiency. Exhaust hoods in food preparation centers shall have a minimum exhaust rate of 50 cubic feet a minute for each square foot (0.25 cubic meters a second for each square meter) of hood face area. All hoods over cooking ranges shall be equipped with fire extinguishing systems interconnected to shut off the fuel source. Cleanout openings shall be provided every 20 feet (6.10 meters) in horizontal exhaust duct systems serving hoods.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
44:76:11:23. Plumbing fixtures. The material used for plumbing fixtures shall be of nonabsorptive acid-resistant material. Each lavatory and sink required in patient care areas shall have the water supply spout mounted so that the discharge is a minimum of five inches (0.13 meters) above the rim of the fixture. Handwashing facilities used by medical and care staff, patients, and food handlers shall be equipped with hands-free controls. Single lever devices may be used. Handles on scrub sinks and clinical sinks may not be less than six inches (0.15 meters) long. Each clinical sink shall have an integral trap in which the upper portion of a visible trap seal provides a water surface. If blade handles are used, proper clearance shall be maintained for operation. Aerators are not approved for use on faucet spouts. Paper towel dispensers or hand-drying devices shall be provided at each lavatory and sink used for handwashing. A mirror or paper towel dispenser with reflective surfaces may not be provided at each handwashing facility in the laboratory, nursery, clean utility, central sterilizing, dietary, or other critical area where grooming could potentially cause contamination.
Each water closet shall be an elongated bowl type and be equipped with an open front seat.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:11:24. Water supply systems. Water supply systems shall supply water to the fixtures and equipment on the upper floors at a minimum pressure of 15 pounds a square inch (1,055.9 kilograms a square meter) during maximum demand periods. Each water service main, branch main, riser, and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture. Hot, cold, and chilled water piping and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.
Water supply systems in a health care facility must maintain one part per million free residual chlorine at remote point-of-use fixtures in the facility or may use another bacteriological control method (increasing water temperature range from 122 degrees to 125 degrees Fahrenheit [50-52 degrees centigrade] is acceptable) that has been demonstrated to be equivalent in control of Legionella. The facility must document water temperatures to verify the hot water temperature is being maintained within the acceptable range The chlorine testing must be done daily using photocell and light source DPD (N, N, Diethyl-p-phenylenediamine) test kits and the test results logged. When testing demonstrates that consistent chlorine levels are maintained, the frequency of testing may be reduced to a level necessary to demonstrate compliance.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (4), and (14).
Law Implemented: SDCL 34-12-13(1), (4), and (14).
44:76:11:25. Vacuum breakers. An antisiphon device or backflow preventer shall be installed on hose bibs and on all fixtures to which hoses or tubing can be attached such as laboratory and janitors' sinks, bedpan flushing attachments, and handheld showers. An antisiphon device or backflow preventer shall be installed on all plumbing and equipment where any possibility exists for contamination of the potable water supply.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (4), and (14).
Law Implemented: SDCL 34-12-13(1), (4), and (14).
44:76:11:26. Hot water systems. Hot water distribution systems over 50 feet (15.24 meters) long shall recirculate to provide hot water at each fixture at all times. The hot water heating equipment shall have sufficient capacity to supply water at the temperature and amounts needed for facility operations.
Each storage tank provided shall be fabricated of noncorrosive metal or lined with noncorrosive material.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (4), and (14).
Law Implemented: SDCL 34-12-13(1), (4), and (14).
44:76:11:27. Drainage systems. Each drain line from sinks in which acid wastes may be poured shall be fabricated from an acid resistant material. Any piping over each operating and delivery room, nursery, food preparation center, food serving facility, food storage area, and any other critical area shall be kept to a minimum and may not be exposed. Special precautions shall be taken to protect these areas from possible leakage of necessary overhead piping systems. Floor drains may not be installed in operating and delivery rooms. Building sewers shall discharge into a community sewerage system. Where such a system is not available, a facility providing sewage treatment which conforms to applicable local and state regulations is required.
Water from roof systems shall be collected and discharged away from the building foundation. Rain gutters with downspouts and splash blocks shall be provided for pitched roof systems. Provisions shall be made to avoid having water accumulated on sidewalks and parking areas around the building.
The building sewer system shall have a cleanout located outside the perimeter of the building foundation.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (4), and (14).
Law Implemented: SDCL 34-12-13(1), (4), and (14).
Cross-Reference: Individual and small on-site wastewater systems, ch 74:53:01.
44:76:11:28. Electrical distribution system. All material including equipment, conductors, controls, and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facilities shown in the specifications or indicated on the plans. All materials shall be listed as complying with applicable standards of Underwriters' Laboratories, Inc., or other similarly established standards. Fixed and mobile X ray units shall be connected by means of independent feeders or circuits. Circuit breakers or fusible switches that provide disconnecting means and overcurrent protection for conductors connected to switchboards and distribution panel boards shall be enclosed or guarded to provide a dead front type of assembly. The main switchboard shall be located in a separate enclosure accessible only to authorized persons. The switchboard shall be convenient for use, readily accessible for maintenance, clear of traffic lanes, and in a dry ventilated space devoid of corrosive fumes or gases. Overload protective devices shall be designed for operating in the ambient temperature conditions. Lighting and appliance panel boards shall be provided for the circuits on each floor. The provisions of this section do not apply to emergency system circuits.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (14).
Law Implemented: SDCL 34-12-13(1), (3), and (14).
44:76:11:29. Lighting. Any space occupied by people, machinery, or equipment within buildings, the approaches to the buildings, and parking lots shall have artificial lighting approved by the department. Each patient treatment room shall have general lighting of at least ten footcandles (0.929 lumens per square meter). If task illumination is required, a light with an intensity of at least 30 footcandles (2.79 lumens per square meter) at the work surface shall be provided for each patient. Any fixed light not switched at the door shall have a switch control convenient for use at the luminaire. Each switch for control of lighting in a patient area shall be of the quiet operating type. Illumination of at least 100 footcandles (9.29 lumens per square meter) shall be provided at the medication set-up area. Illumination of at least 30 footcandles (2.79 lumens per square meter) shall be provided in each physical and restorative therapy area, and at any bathing facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
44:76:11:30. Receptacles or convenience outlets. Each operating room shall have at least three receptacles. In locations where mobile X ray is used, an additional receptacle, distinctively marked for X ray use, shall be provided. Each treatment room shall have duplex receptacles as follows: one on each side of the head of each patient table; receptacles for luminaires and motorized beds, if used; and one receptacle on each wall. Single polarized receptacles marked for use of X ray only shall be located in corridors of patient areas so that mobile equipment may be used in any location within a patient room. If the same mobile X ray unit is used in operating rooms, all receptacles for X ray use shall be the same. Where capacitive discharge or battery-powered mobile X ray units are used, polarized receptacles are not required. Duplex receptacles for general use shall be installed approximately 50 feet apart in all corridors and within 25 feet of ends of corridors. Receptacles in pediatric units shall be of the safety type.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(4) and (14).
Law Implemented: SDCL 34-12-13(4) and (14).
44:76:11:31. Staff call system. A staff call system shall be provided for patient use at each recovery station that will register a call from the patient both visually and audibly at the staff call station and actuate a visual signal at the patient recovery room door, and in the clean workroom, soiled workroom, and nourishment station of the nursing unit. Nurses call systems which provide two-way voice communication shall be equipped with an indicating light at each calling station which lights and remains lighted as long as the voice circuit is operating. An emergency calling station convenient for patient use shall be provided at each patient toilet, bath, or shower and at toilets serving patients in laboratory, physical therapy, preoperative and postoperative holding space, and X ray departments. An emergency nurses calling station shall be provided for staff use in each operating and recovery room.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-1-17, 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:11:32. Submittal of plans and specifications. Plans and specifications for new construction shall be submitted to the department for evaluation of function and fire protection including concealed spaces. The department's approval shall be obtained before beginning construction. Modification during construction shall be submitted to the department for review and shall be approved prior to the modification. A written narrative describing the intended use of the proposed construction shall accompany the plans and specifications.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:11:33. Pipe requirements. All piping systems for potable water shall be installed to eliminate any dead-end runs of piping. Before placing potable water systems in service, the piping system shall be disinfected in accordance with the South Dakota Plumbing Commission standards in article 20:54 and certification shall be available from the installer showing the method used, date, test procedure used to verify chlorine concentrations, and date the system was flushed and placed in service.
Pipe covering, vapor barriers, and adhesives used for applying them shall have a flame spread of not more than 25 and a smoke emission factor of not more than 50 when tested in accordance with the NFPA 101 Life Safety Code, 2012 edition.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
Reference: NFPA 101 Life Safety Code, 2012 edition, National Fire Protection Association. Copies may be obtained from the National Fire Protection Association, P.O. Box 9101, Quincy, Massachusetts 02269-9101. Phone: 1-800-344-3555. Cost: $93.00.
44:76:11:34. Detached structures. A detached structure or auxiliary building used for combustible storage or vehicle parking built adjacent to, but not directly attached to, a health care facility shall either be separated from the facility by a minimum distance of 20 feet, provided with two-hour fire rated separation, or equip structure with a complete automatic sprinkler system.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
Cross-Reference: Fire safety code requirements, § 44:76:03:01.
CHAPTER 44:76:12
ADDITIONAL AMBULATORY SURGERY CENTER STANDARDS
Section
44:76:12:01 Application of standards.
44:76:12:02 Surgical suites.
44:76:12:03 Service areas in surgical suite.
44:76:12:04 Diagnostic imaging suite.
44:76:12:05 Laboratory suite.
44:76:12:06 Pharmacy or drug room.
44:76:12:07 Central medical and surgical supply department.
44:76:12:08 Central stores.
44:76:12:09 Details and finishes.
44:76:12:10 Ventilation.
44:76:12:11 Air filters.
44:76:12:12 Ducts.
44:76:12:13 Plumbing fixture devices.
44:76:12:14 Operating room lighting.
44:76:12:15 Equipment installation in special areas.
44:76:12:16 Emergency electric supply.
44:76:12:17 Emergency electrical circuit connections.
44:76:12:18 Emergency electrical system details.
44:76:12:01. Application of standards. The construction standards in this chapter apply to all new facilities and to alterations, additions, and changes in space use to existing facilities.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-1-17(4) and (5), 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
44:76:12:02. Surgical suites. The number of operating rooms shall be based on the expected surgical workload. The surgical suite shall be located to prevent through traffic. A recovery room with charting space, medication storage and preparation space, and a clinical sink is required.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
44:76:12:03. Service areas in surgical suite. The size of the service areas in each surgical suite depends on the surgical workload. Each surgical suite shall include the following service areas:
(1) A surgical supervisor station;
(2) Sterilizing facilities near the operating room with high speed autoclave;
(3) Facilities for storage and preparation of medication;
(4) Scrub-up facilities located adjacent to operating rooms;
(5) Soiled workroom containing a work counter clinical sink, hand sink, waste receptacle, and soiled linen receptacles;
(6) Storage for sterile and unsterile supplies, which may be in a clean workroom;
(7) Storage room or cabinet for anesthetic agents;
(8) Nitrous oxide and oxygen facilities with storage room if these services are not piped in;
(9) Clean work area for storage and assembly of supplies containing counter and sink;
(10) Equipment storage area for surgical and monitoring equipment;
(11) Floor receptor or service sink and storage for housekeeping supplies and equipment;
(12) Clothing change areas, lockers, and toilet rooms for doctors, nurses, technicians, and other personnel;
(13) Holding area for patients in facilities with two or more operating rooms; and
(14) Stretcher alcove.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
44:76:12:04. Diagnostic imaging suite. The diagnostic imaging suite shall contain:
(1) One or more radiographic rooms with necessary radiation protection;
(2) A film processing room, if required;
(3) A film filing room;
(4) Toilet room adjoining each fluoroscopy and ultrasound room;
(5) Dressing area for ambulatory patients;
(6) Holding area for stretcher patients;
(7) Waiting space; and
(8) An office with film viewing facilities.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
44:76:12:05. Laboratory suite. Clinical laboratory facilities and equipment consistent with the needs of the patients shall be provided. Handwashing fixtures shall be provided and equipped with faucets which can be operated without the use of hands.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
44:76:12:06. Pharmacy or drug room. The pharmacy or drug room shall be well ventilated and have a locking door. The pharmacy or drug room shall be sized for the distribution system used and shall have a work counter with sink, a separate locked and fastened compartment or room for the storage of controlled substances, refrigerated and frozen storage spaces, and other approved storage for drugs. If additive injectables are prepared, a sterile products area shall be provided. The work space shall be well illuminated. Emergency power shall be provided for essential services. Heating, ventilation, and air conditioning services shall be provided to maintain the temperature of the room between 59 degrees Fahrenheit (15 degrees centigrade) and 86 degrees Fahrenheit (30 degrees centigrade).
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), (4) and (9).
Law Implemented: SDCL 34-12-13(1), (3), (4) and (9).
44:76:12:07. Central medical and surgical supply department. The clean and soiled areas of the central medical and surgical supply department shall be separated from each other. Space for cleaning equipment and disposing or processing of unclean articles shall be provided in the decontamination area and the plumbing fixtures shall be at least those provided for the soiled utility room. The clean workroom shall be divided into work space, clean storage area, sterilizing facilities, and storage area for sterile supplies. Pathological waste sterilization may not be done in this area. An unsterile supply storage area shall be provided, but it may be located in an area outside this department. Handwashing fixtures shall be provided between the clean and soiled work areas.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:12:08. Central stores. General central storage rooms shall have a total area of not less than 20 square feet (1.86 square meters) for each operating or procedure room. General storage should be concentrated in one area on-site, but up to 50 percent of the general storage space may be provided off-site.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
44:76:12:09. Details and finishes. Ceiling heights of operating rooms, cystoscopic rooms, radiographic rooms, and rooms with ceiling-mounted surgical light fixtures shall be at least nine feet (2.74 meters).
The ceilings in isolation rooms, X-ray film processing rooms, central sterilization rooms, and operating rooms shall be an epoxy painted gypsum board membrane or an equivalent material for ease of cleaning and for improved maintenance of clean surfaces below the ceilings.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
44:76:12:10. Ventilation. All air supply and air exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at the discharge end of the system. All air supplied to an operating room or sensitive area shall be delivered at or near the ceiling of the area served. All air exhausted from the area shall be removed near floor level. At least two exhaust outlets shall be used in each operating room. Exhaust wall outlets shall be located not less than three inches (0.076 meters) above the floor.
A ventilation system in operating, isolation, or central sterilization shall be a ducted system. A ventilation system using the building concealed space (return air plenum) from a clean room is not acceptable.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (4).
Law Implemented: SDCL 34-12-13(1), (3), and (4).
44:76:12:11. Air filters. A ventilation system shall be equipped with a minimum of two filter beds. Filter bed number one shall be located upstream of the conditioning equipment and shall have a minimum efficiency of 30 percent. Filter bed number two shall be located downstream of the conditioning equipment and shall have a minimum efficiency of 90 percent. Central systems serving other than sensitive areas shall be provided with filters rated at 80 percent efficiency. These filter efficiencies shall be warranted by the manufacturer and shall be based on the ASHRAE 52.2, 2007 edition, American Society of Heating, Refrigeration, and Air Conditioning Engineers dust spot test method with atmospheric dust. The exhausts from all laboratory hoods in which infectious or radioactive materials are processed shall be equipped with filters with a 99 percent efficiency. Filter frames shall be durable and shall provide an airtight fit with the enclosing ductwork. All joints between filter segments and the enclosing ductwork shall have positive seal against air leakage.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(2), (3), and (14).
Law Implemented: SDCL 34-12-13(2), (3), and (14).
Reference: "ASHRAE 52.2," 2007 edition, American Society of Heating, Refrigeration, and Air Conditioning Engineers, 1791 Tullie Circle, N.E., Atlanta GA 30329. Phone: 1-800-527-4723. Cost: $39.00.
44:76:12:12. Ducts. Ducts which penetrate construction intended for X ray or other ray protection may not impair the effectiveness of the protection. Porous duct lining materials may not be used in the interior of duct systems serving sensitive areas such as operating rooms and isolation rooms.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (2), (3), and (14).
Law Implemented: SDCL 34-12-13(1), (2), (3), and (14).
44:76:12:13. Plumbing fixture devices. Bedpan flushing devices shall be provided in each soiled workroom.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1) and (3).
Law Implemented: SDCL 34-12-13(1) and (3).
44:76:12:14. Operating room lighting. Operating rooms shall have general lighting for the room in addition to special lighting units at the surgical tables. Each special lighting unit for local lighting at tables shall be connected to an independent circuit.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3) and (4).
Law Implemented: SDCL 34-12-13(3) and (4).
44:76:12:15. Equipment installation in special areas. X ray stationary installations and mobile equipment shall conform to rules of the state electrical commission.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(3).
Law Implemented: SDCL 34-12-13(3).
Cross-Reference: Electrical installations, ch 20:44:05.
44:76:12:16. Emergency electric supply. Each facility shall have an emergency source of electric supply to provide electricity during an interruption of the normal electric supply. The source of emergency electric supply shall be an automatic emergency generating set when the normal service is supplied by one or more central station transmission lines, or an automatic generating set or a central station transmission line when the normal electric supply is generated on the premises. The required emergency generating set, including the prime mover and generator, shall be located on the premises. The emergency generator set shall be of sufficient kilowatt capacity to supply all lighting and power load demands of the emergency system.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (14).
Law Implemented: SDCL 34-12-13(1), (3), and (14).
44:76:12:17. Emergency electrical circuit connections. Emergency electrical service shall be furnished to circuits as follows:
(1) Lighting of exit ways and all necessary ways of approach to them, including exit signs and exit direction signs, exterior of exits, exit doorways, stairways, and corridors;
(2) Surgical room operating lights;
(3) Lighting for laboratory, recovery room, staff stations, and medication preparation areas;
(4) Lighting for the generator set location, the switch gear location, and the boiler room;
(5) Equipment essential to life safety and for protection of important equipment or vital materials;
(6) Staff calling system;
(7) Alarm system, including fire alarms actuated at manual stations;
(8) Water flow alarm devices of sprinkler system if electrically operated;
(9) Fire detecting and smoke detecting systems;
(10) Paging or speaker systems if intended for issuing instructions during emergency conditions;
(11) Alarms required for nonflammable medical gas systems, if installed;
(12) Pump for central suction system;
(13) Sewage or sump lift pump, if installed;
(14) Receptacles for blood bank refrigerator;
(15) At least two duplex receptacles for the laboratory;
(16) Receptacles in operating and recovery rooms except those for X ray;
(17) Duplex receptacles in patient corridors; and
(18) Equipment, such as burners and pumps, necessary for operation of one or more boilers required for heating and sterilization and their necessary auxiliaries and controls.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (14).
Law Implemented: SDCL 34-12-13(1), (3), and (14).
44:76:12:18. Emergency electrical system details. The emergency electrical system shall be so controlled that after interruption of the normal electric power supply the generator is brought to full voltage and frequency and connected within ten seconds through one or more primary automatic transfer switches to all emergency lighting; all alarms; blood banks; staff call; equipment necessary for maintaining telephone service; pump for central suction system; and receptacles in operating rooms, patient corridors, and recovery rooms. All other lighting and equipment required to be connected to the emergency system shall either be connected through the primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. A receptacle connected to the emergency system shall be distinctively marked for identification. A storage-battery-powered light, provided to augment the emergency lighting or for continuity of lighting during the interim of transfer switching immediately following an interruption of the normal service supply, may not be used as a substitute for the required generator. If fuel is normally stored on the site, the storage capacity shall be sufficient for 24-hour operation. If fuel is normally piped underground to the site from a utility distribution system, storage facilities on the site are not required.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(1), (3), and (14).
Law Implemented: SDCL 34-12-13(1), (3), and (14).
CHAPTER 44:76:13
PATIENTS' RIGHTS
Section
44:76:13:01 Application of chapter - Patients' rights policies.
44:76:13:02 Facility to inform patient of rights.
44:76:13:03 Facility to provide information on available services.
44:76:13:04 Notification when patient's condition changes.
44:76:13:05 Choice in planning care.
44:76:13:06 Privacy and confidentiality.
44:76:13:07 Grievances.
44:76:13:08 Availability of survey results.
44:76:13:09 Self-administration of drugs.
44:76:13:10 Advance directive.
44:76:13:11 Admission, transfer, and discharge policies.
44:76:13:01. Application of chapter - Patients' rights policies. Each facility shall establish policies consistent with this chapter to protect and promote the rights of the patient.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(15).
Law Implemented: SDCL 34-12-13(15).
44:76:13:02. Facility to inform patient of rights. Prior to or at the time of admission, a facility shall inform the patient, both orally and in writing, of the patient's rights and of the rules governing the patient's conduct and responsibilities while in the facility. The patient shall acknowledge in writing that the patient received the information. During the patient's stay the facility shall notify the patient, both orally and in writing, of any changes to the original information. The facility shall post written notice of patient rights in a place likely to be noticed by patients waiting for treatment or provided to the patients’ representative or surrogate. The patient's right to receive visitors. Visiting hours and policies of the facility shall permit and encourage the visiting of patients by friends and relatives. Visitors may not cause a disruption to the care and services residents receive or infringement on other patients' rights or place an undue burden on the facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:13:03. Facility to provide information on available services. A facility shall provide the following information in writing to each patient:
(1) A list of services available in the facility and the charges for such services. The facility shall specify which items and services are included in the services for which the patient may not be charged, those other items and services that the facility offers and for which the patient may be charged, and the amount of any such charges;
(2) A list of names, addresses, and telephone numbers of client advocates;
(3) A description of how to file a complaint with the department concerning abuse, neglect, and misappropriation of patient property;
(4) A description of how the patient can contact the patient's physician, including the name and specialty of the physician;
(5) A description of how to apply for and use Medicare and Medicaid benefits, and the right to establish eligibility for Medicaid, including the addresses and telephone numbers of the nearest office of the South Dakota Department of Social Services and of the United States Social Security Administration; and
(6) A description explaining the responsibilities of the patient and family members regarding self-administered medication.
A signed and dated admission agreement between the patient or the patient's legal representative and the facility shall include subdivisions (1) to (6), inclusive, of this section. The patient or patient's legal representative and the facility shall complete the admission agreement before or at the time of admission and before the patient has made a commitment for payment for proposed or actual care. The agreement may not include ambiguous or misleading information and may not be in conflict with this chapter. The agreement shall be printed for ease of reading by the patient. If the agreement exceeds three pages, it shall contain a table of contents or an index of principal sections. Any change in the information shall be given to the patient or the patient's legal representative as a signed and dated addendum to the original agreement.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:13:04. Notification when patient's condition changes. A facility shall immediately inform the patient, consult with the patient's physician, and, if known, notify the patient's legal representative or interested family member when any of the following occurs:
(1) An accident involving the patient which results in injury or has the potential for requiring intervention by a physician;
(2) A significant change in the patient's physical, mental, or psychosocial status;
(3) A need to alter treatment significantly; or
(4) A decision to transfer or discharge the patient from the facility.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:13:05. Choice in planning care. A patient may choose a personal attending physician, be fully informed in advance about care and treatment and of any changes in that care or treatment that may affect the patient's well-being, and, unless adjudged incompetent or otherwise found to be incapacitated under the laws of the state, participate in planning care and treatment or changes in care or treatment.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
Cross-References:
Right to choose own physician unimpaired by public health programs -- Misdemeanor, SDCL 34-1-20.
Rights of authorized person as incapacitated person, SDCL 34-12C-6.
Liability of health care provider -- Liability of authorized decision maker, SDCL 34-12C-7.
44:76:13:06. Privacy and confidentiality. A facility shall provide for privacy and confidentiality for the patient, including the patient's accommodations, medical treatment, written and telephone communications, personal care, visits, and meetings of family and patient groups.
To approve or refuse the release of personal and medical records to any individual outside the facility, except when the patient is transferred to another health care facility or when the release of the record is required by law. With the patient's permission, a facility shall allow the state ombudsman or a representative of the ombudsman access to the patient's medical records.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
Cross-Reference: Written policies and confidentiality of records, § 44:76:08:03.
44:76:13:07. Grievances. A patient may voice grievances without discrimination or reprisal. A patient's grievance may be in writing or oral and may relate to treatment furnished, treatment that has not been furnished, the behavior of other patients, and infringement of the patient's rights. A facility shall adopt a grievance process and make the process known to each patient and to the patient's immediate family. The grievance process shall include the facility's efforts to resolve the grievance and documentation of:
(1) The grievance;
(2) The names of the persons involved;
(3) The disposition of the matter; and
(4) The date of disposition.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:13:09. Self-administration of drugs. A patient may self-administer drugs if approved by the physician and determined the practice to be safe. The determination shall state whether the patient or the nursing staff is responsible for storage of the drug and documentation of its administration in accordance with chapter 44:76:07.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13(15).
Law Implemented: SDCL 34-12-13(15).
Cross-Reference: Medication control, ch 44:76:07.
44:76:13:10. Advance Directive. The facility shall provide the patient or the patients' representative, as appropriate, the following:
(1) Information on the facility's policies on advance directives;
(2) A description of the applicable state health and safety laws; and
(3) State advance directive forms if requested by patients.
Include in the facility policies a clear and precise statement on limitations if the facility cannot implement an advance directive on the basis of conscience or any other specific reason that is permitted under state law. A blanket statement of refusal by the facility to comply with any patient advance directives is not permissible. However, if and to the extent permitted under state law, the facility may decline to implement elements of an advance directive on the basis of conscience or any other reason permitted under state law if it includes in the information concerning its advance directive policies a clear and precise statement of limitation. A statement of limitation shall:
(1) Clarify any differences between facility wide conscience objections and those that may be raised by individual facility staff;
(2) Identify the state legal authority permitting such objection; and
(3) Describe the range of medical conditions and procedures affected by the objection.
The facility shall document in a prominent part of the patient’s current medical record where it will be readily noticeable by any facility staff providing clinical services whether or not the patient has executed an advance directive.
If the patient with an advance directive is transferred from the facility to another healthcare facility, the facility shall ensure a copy of the patient's advance directive is provided with the medical record when the patient is transferred. The facility shall provide education to its staff on the facility's policies and procedures on advance directives.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.
44:76:13:11. Admission, transfer, and discharge policies. A facility shall establish and maintain policies and practices for admission, discharge, and transfer of patients which prohibit discrimination based upon payment source and which are made known to patients at or before the time of admission.
Source: 42 SDR 51, effective October 13, 2015.
General Authority: SDCL 34-12-13.
Law Implemented: SDCL 34-12-13.