44:69:01:01.  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 gestures, or engaging in other acts made to or directed at a patient or resident;

 

          (2)  "Adequate staff," a sufficient number of qualified personnel to perform the duties required to meet the performance criteria established by this article;

 

          (3)  "Administrator," a person appointed by the owner or governing body of a birth center who is responsible for managing the birth center and who maintains an office on the premises of the birth center;

 

          (4)  "Birth center," any health care facility licensed under this article at which a woman is scheduled to give birth following a normal, uncomplicated pregnancy, but does not include a hospital or the residence of the woman giving birth;

 

          (5)  "Certified nurse midwife," a provider duly authorized under this chapter to practice the nursing specialty of nurse midwifery as defined in SDCL 36-9A-1;

 

          (6)  "Client," a woman who is scheduled to give birth at a birth center and the newborn of that birth;

 

          (7)  "Client advocates," agencies responsible for the protection and advocacy of clients, including the department, the state ombudsman, the protection and advocacy network, and the Medicaid fraud control unit;

 

          (8)  "Department," the South Dakota Department of Health;

 

          (9)  "Dietary manager," a person who is a dietitian, a graduate of an accredited dietetic technician or dietetic manager training program, a graduate of a course that provides 120 or more hours of classroom instruction in food service supervision, or a certified dietary manager recognized by the National Certifying Board of Dietary Managers and who functions with consultation from a dietitian;

 

          (10)  "Dietitian," a person who is registered with the Commission on Dietetic Registration of the American Dietetic Association and holds a current license to practice in South Dakota pursuant to SDCL chapter 36-10B;

 

          (11)  "Distinct part," an identifiable unit, such as an entire ward or contiguous wards, wing, floor, or building, which is licensed at a specific level. The term includes all beds and related facilities in the unit;

 

          (12)  "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;

 

          (13)  "Exploitation," the wrongful taking or exercising of control over property of a person with intent to defraud that person;

 

          (14)  "Facility," the place of business used to provide health care for clients;

 

          (15)  "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;

 

          (16)  "Healthcare worker," any paid person working in a health-care setting;

 

          (17)  "Legend drug," any drug that requires the label bearing the statement "Caution: Federal law prohibits dispensing without prescription";

 

          (18)  "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 but not limited to offensive behavior made to or directed at a client, 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;

 

          (19)  "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;

 

          (20)  "Nurse aide," a person providing nursing or nursing-related services who is not a licensed health care worker, or someone who volunteers to provide such services without pay;

 

          (21)  "Nurse practitioner," a provider duly authorized under this chapter to practice the specialty of nurse practitioner as defined in SDCL 36-9A-1;

 

          (22)  "Nursing personnel," staff which includes registered nurses, licensed practical nurses, certified nurse midwife, nurse aides, restorative aides, and orderlies;

 

          (23)  "Nursing unit," a client unit that is limited to one floor of a birth center and has all client room entrances and exits within sight or control of nursing personnel;

 

          (24)  "Pharmacist," a person registered to practice pharmacy pursuant to SDCL chapter 36-11;

 

          (25)  "Physician," a person who is licensed or approved to practice medicine pursuant to SDCL chapter 36-4;

 

          (26)  "Practitioner," a person who is:

 

               (a)  Licensed or approved to practice medicine pursuant to SDCL chapter 36-4; or

               (b)  Licensed to practice nurse midwifery pursuant to SDCL chapter 36-9A;

 

          (27)  "Practitioner 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 clients in a birth center;

 

          (28)  "Qualified personnel," persons with the specific education, license, and training to provide the health service for which they are employed;

 

          (29)  "Regular diet," a nutritionally adequate diet using food items and written recipes that can be prepared and correctly served by a staff person;

 

          (30)  "Self-administration of medications," the removal of the correct dosage from the pharmaceutical container and self-injecting, -ingesting, or -applying the medication with no assistance or with assistance from qualified personnel of the birth center for the correct dosage or frequency;

 

          (31)  "Social worker," a person who is licensed pursuant to SDCL chapter 36-26;

 

          (32)  "Therapeutic diet," any diet other than a regular diet that is ordered by a physician as part of the treatment for a disease or clinical condition to increase, decrease, or to eliminate certain substances in the diet, and to alter food consistency; and

 

          (33)  "Transfer or discharge," the movement of a client to a bed outside the distinct part or outside the birth center.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62.

          Law Implemented: SDCL 34-12-7, 34-12-62.

 

          44:69:01:02.  Name of birth center. Each birth center 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 birth center 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: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62.

          Law Implemented: SDCL 34-12-5, 34-12-7, 34-12-62.

 

          44:69:01:03.  Bed capacity. The department shall establish the bed capacity of each birth center pursuant to the physical plant and space provisions of this article. Where indicated, additional regulations specific to birth centers with three or more beds apply. The client census may not exceed the bed capacity for which the birth center is licensed. A request by the birth center for an adjustment in bed capacity because of change of purpose or construction shall be approved by the department before any changes are made.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62.

          Law Implemented: SDCL 34-12-5, 34-12-7, 34-12-62.

 

          44:69:01:04.  Restrictions on acceptance of clients. A birth center shall accept clients in accordance with the following restrictions:

 

          (1)  A client admitted to a birth center shall be housed within the birth center covered by the license;

 

          (2)  A licensed birth center may not accept or retain clients who require care in excess of the classification for which it is licensed; and

 

          (3)  Personnel essential to maintaining adequate staff may not leave a licensed birth center during their tour of duty in the birth center to provide services to persons who are not clients of the birth center with the exception of providing emergency care on premises contiguous to the birth center's property.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(12).

          Law Implemented: SDCL 34-12-62(12).

 

          44:69:01:05.  Joint occupancy. The use of a portion of a building for purposes 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 clients. The area shall be open to inspection by the department.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:01:06.  Reports. Each licensed birth center shall submit to the department the pertinent data necessary to comply with the requirements of SDCL chapter 34-12 and this article.

 

          Each birth center shall report to the department within 48 hours of the event any death on birth center property and any allegation of abuse or neglect of any client by any person.

 

          Each birth center shall also report to the department as soon as possible any fire with structural damage or where injury or death occurs; any partial or complete evacuation of the birth center 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 birth center for more than 24 hours,

 

          Each birth center shall notify the department of any anticipated closure or discontinuance of service at least 30 days in advance of the effective date.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1) and (4).

          Law Implemented: SDCL 34-12-62(1) and (4).

 

          44:69:01:07.  Plans of correction. Within 15 days of the receipt of the statement of deficiencies, each birth center shall submit to the department a written plan of correction for citations 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 birth center to attain or maintain compliance with SDCL chapter 34-12 and this article.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62.

          Law Implemented: SDCL 34-12-62.

 

          44:69:01:08.  Modifications. Modifications to the staffing requirements provided in § 44:69:03:02 may be approved by the department for licensed birth centers which are physically combined and jointly operated. The health and safety of the client in either birth center may not be jeopardized.

 

          Modifications specified by this section may be requested by the birth center. If the department approves the modifications, the approval shall be in writing. The approval letter shall specify the modifications permitted and any limitations pertaining to the modifications.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:01:09.  Scope of article. Nothing in article 44:69 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: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(2).

          Law Implemented: SDCL 34-12-62(2).

 

          44:69:02:01.  Sanitation. The birth center shall be designed, constructed, maintained, and operated to minimize the sources and transmission of infectious diseases to clients, personnel, visitors, and the community at large.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:02:02.  Pets. Any pet kept in a birth center may not negatively affect the well-being of clients.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(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.

 

          44:69:02:03.  Cleaning methods and facilities. The birth center shall have equipment, work areas, and complete written procedures for cleaning, sanitizing, disinfecting, or sterilizing all work areas, equipment, utensils, dressings, medical devices, and solutions used for clients' care. Common use equipment shall be disinfected or sterilized after each use.

 

          A separate clean and soiled utility room shall be provided for birth centers with three or more beds.

 

          All parts of the birth center shall be kept clean, neat, and free of visible soil, litter, and rubbish.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:02:04.  Sterilization. Instruments, supplies, utensils and equipment which are not single service shall be decontaminated before sterilization in a manner that makes 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 birth center. Autoclaves used for steam sterilization shall be bacteriologically monitored at least weekly. Supplies and equipment sterilized and packaged in the birth center shall have the processing date on the package and shall be reprocessed in accordance with any specific manufacturer's recommendation for the packaging.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(7).

          Law Implemented: SDCL 34-12-62(7).

 

          44:69:02:05.  Food service. If an in-house food service is provided, the birth center 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, in the Food Service Code. The birth center shall have the space, equipment, supplies, and mechanical systems for efficient, safe, and sanitary food preparation. If a birth center's food service is contracted out, the contractor shall be a licensed food service establishment that is inspected by a local, state, or federal agency.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(9) and (13).

          Law Implemented: SDCL 34-12-62(9) and (13).

 

          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 $4.08.

 

          44:69:02:06.  Linen. The supply of bed linen and towels shall equal two times the licensed capacity. Each birth center shall contract with commercial laundry services 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 birth center providing laundry services shall have adequate space and equipment for the safe and effective operation of the laundry service.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(7) and (13).

          Law Implemented: SDCL 34-12-62(7) and (13).

 

          44:69:02:07.  Infection control. The infection control program shall utilize the concept of standard precautions as the basis for infection control pursuant to chapter 44:20:04. The birth center shall have written procedures that govern the use of aseptic techniques and procedures in all areas of the birth center. Each birth center shall develop policies and procedures for the handling and storage of potentially hazardous substances (including lab specimens).

 

          A birth center with three or more beds shall designate an employee to be responsible for the implementation of the infection control program including surveillance and reporting activities.

 

          Each birth center shall provide an organized infection control program for preventing, investigating, and controlling infection.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(7).

          Law Implemented: SDCL 34-12-62(7).

 

          44:69:02:08.  Occupant protection. Each birth center shall be constructed, arranged, equipped, maintained, and operated to avoid injury or danger to any occupant. The extent and complexity of occupant protection precautions is determined by the services offered and the physical needs of any client admitted to the birth center.

 

          A birth center with three or more beds 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 clients;

 

          (3)  Provide a call system for each birth room and in all toilet rooms and bathing facilities routinely used by clients. The call system shall be capable of being easily activated by a client and shall register at a staff location. 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)  Portable space heaters and portable halogen lamps may not be used in a birth center;

 

          (6)  Household-type electric blankets or heating pads may not be used in a facility;

 

          (7)  Any light fixture located over a client bed, 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; and

 

          (8)  Any clothes dryer shall have a galvanized metal vent pipe for exhaust.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1), (5), and (6).

          Law Implemented: SDCL 34-12-62(1), (5), and (6).

 

          44:06:02:09.  Physical plant changes. A birth center 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: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:02:10.  Location. The location of a birth center shall promote the health, treatment, comfort, safety, and well-being of persons accepted and retained for care. A birth center shall be served by good, passable roads. Easy accessibility for employees, visitors, and fire-fighting services shall be maintained.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:02:11.  Other hazardous conditions. A birth center may be directed to remove or correct other hazardous conditions not covered in this chapter if the department considers the conditions to have the potential to cause injury or illness to any client or staff.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:03:01.  Fire standards and general fire safety. Each birth center shall meet applicable fire safety standards in NFPA 101 Life Safety Code, 2009 edition.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          Reference: NFPA 101 Life Safety Code, 2009 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: $76.50.

 

          44:69:03:02.  General fire safety. Each birth center 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. 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. At least two staff members shall be on duty if a client is present. In a multilevel birth center, 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: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1).

          Law Implemented: SDCL 34-12-62(1).

 

          44:69:04:01.  Governing body. Each birth center operated by limited liability partnership, a corporation, or political subdivision shall have an organized governing body legally responsible for the overall conduct of the birth center. If the birth center is operated by an individual or partnership, the individual or partnership shall carry out the functions in this article pertaining to the governing body. The governing body shall establish and maintain administration policies, procedures, or bylaws governing the operation of the birth center. The governing body shall review and approve the credentials of physicians and certified nurse midwives permitted to attend births. There shall be a system established to reevaluate credentials every two years.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(2).

          Law Implemented: SDCL 34-12-62(2).

 

          44:69:04:02.  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 birth center. The governing body shall notify the department in writing of any change of administrator.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(2).

          Law Implemented: SDCL 34-12-62(2).

 

          44:69:04:03.  Personnel. The birth center 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 birth center shall not knowingly employ any person with a conviction for abusing another person. The birth center shall establish and follow policies regarding special duty or staff members on contract.

 

          Any staff and any consultant or volunteer providing services under the auspices of the birth center who is required by state law to be licensed, registered, or certified shall have a valid license, registration, or certificate. A copy of the license, registration, or certificate shall be on file with the birth center. At least one staff member on duty during active labor shall be certified in adult and neonatal CPR.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(2).

          Law Implemented: SDCL 34-12-62(2).

 

          44:69:04:04.  Personnel training. A birth center with three or more beds 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;

          (2)  Emergency procedures and preparedness;

          (3)  Infection control and prevention;

          (4)  Accident prevention and safety procedures;

          (5)  Client rights;

          (6)  Confidentiality of client information;

          (7)  Incidents and diseases subject to mandatory reporting and the birth center's reporting mechanisms;

          (8)  Care of clients with unique needs; and

          (9)  Clinic policies and procedures.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(2) and (9).

          Law Implemented: SDCL 34-12-62(2) and (9).

 

          44:69:04:05.  Personnel policies and procedures. A birth center with three or more beds shall have written policies and procedures that include the following:

 

          (1)  Operational practices that define the services of the birth center;

 

          (2)  Written job descriptions for each position in the birth center including the title, authority, specific responsibilities, and minimum qualifications. Each employee shall be provided a copy of his or her job description;

 

          (3)  All staff shall be informed of, and have access to, the written policies; and

 

          (4)  Personnel records shall be maintained for each person employed in the birth center that include:

 

               (a)  An employment application;

               (b)  Verification of references, licenses, certifications, or credentials;

               (c)  Incident and accident reports; and

               (d)  Results of medical examinations required as part of employment.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(2) and (9).

          Law Implemented: SDCL 34-12-62(2) and (9).

 

          44:69:04:06.  Employee health program. The birth center shall have an employee health program for the protection of the clients. All personnel shall be evaluated by an appropriate 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 tuberculin skin tests. The birth center 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. Personnel absent from duty because of a reportable communicable disease that may endanger the health of clients and fellow employees may not return to duty until they are determined by a physician or the physician's designee to no long have the disease in a communicable state.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(7).

          Law Implemented: SDCL 34-12-62(7).

 

          Cross Reference: Definition of terms, subdivisions 44:20:01:01(8) and (43).

          44:69:04:07.  Admissions to birth center. The governing body or owner of the birth center shall establish and maintain admission, transfer, and discharge policies, with written evidence to assure the clients admitted to and retained in the birth center are within the licensure classification of the birth center. The birth center may admit and retain, on the orders of a physician or certified nurse midwife, only those clients for whom it can provide care safely and effectively. Before admission of a client, the physician or certified nurse midwife shall complete and document an assessment of a potential client prior to accepting the client for admission and shall only admit a client that has been assessed to have a low-risk pregnancy in accordance with § 44:69:05:05. A birth center client shall be continually assessed to identify if her condition deviates from a low-risk pregnancy at any time during the pregnancy, delivery, or postpartum period. The birth center shall refer or transfer the client to a physician or hospital when the client's pregnancy deviates from the status of low-risk pregnancy.

 

          The birth center practitioner shall document information regarding current medical findings, admitting diagnoses, and written orders for the immediate care of the client.

 

          The client's history and physical examination shall be completed upon admission or no more than 24 hours after admission; or within thirty days prior to admission with documentation of an update of the client's current medical status completed upon admission. The client's history and physical examination shall be completed prior to delivery except in emergency situations, a client's transfer, and the client's discharge. A history and physical examination of the newborn infant shall be completed upon birth and prior to discharge.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(12).

          Law Implemented: SDCL 34-12-62(12).

 

          44:69:04:08.  Discharge planning. Each birth center shall have policies and procedures for discharge planning.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(10).

          Law Implemented: SDCL 34-12-62(10).

 

          44:69:04:09.  Quality assessment. Each birth center shall provide for on-going evaluation of the quality of services provided to clients.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(9).

          Law Implemented: SDCL 34-12-62(9).

 

          44:69:05:01.  Practitioner services. Each birth center shall have an organized practitioner service. At least one physician, certified nurse midwife, or registered nurse shall be on duty in the birth center at all times if a client is in active labor. Each licensed practical nurse and other nursing personnel involved in client care shall be under the direct supervision of a physician, certified nurse midwife, or registered nurse.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(2).

          Law Implemented: SDCL 34-12-62(2).

 

          44:69:05:02.  Emergency care. Each birth center shall establish and implement policies and procedures for emergency care and arrange for transport to a licensed hospital sufficiently close to provide prompt care to the birth center's clients if needed.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(3) and (12).

          Law Implemented: SDCL 34-12-62(3) and (12).

 

          44:69:05:03.  Emergency equipment and procedures to provide emergency care. Each birth center shall have in effect a transfer protocol with one or more hospitals sufficiently close to provide prompt inpatient hospital care to the center's clients if needed. The protocol shall provide for an interchange of medical and other information necessary or useful in the care and treatment of individuals transferred between the facilities.

 

          Each birth center shall have:

 

          (1)  Readily accessible emergency carts or trays for the mother and newborn equipped to carry out the written emergency procedure of the center and securely placed with a written log of routine maintenance for readiness;

 

          (2)  Properly maintained equipment and supplies for routine and emergency care of women and newborn including:

 

               (a)  Oxygen with flow meters and masks or equivalent;

               (b)  Mechanical suction and bulb suction;

               (c)  Cardiopulmonary resuscitation cart, including:

 

                      (i)      Resuscitation bags for mother and newborn;

                      (ii)     Endotrachael tubes for mother and newborn;

                      (iii)    Oral airways;

                      (iv)    Needles;

                      (v)     Syringes;

                      (vi)    Emergency drugs;

                      (vii)   Laryngoscope;

                      (viii)  Equipment for delivering positive pressure oxygen; and

                      (ix)    Cardiac monitor/defibrillator unit or automated external defibrillator;

 

               (d)  Emergency medications, intravenous fluids, and related supplies and equipment for both mother and newborn;

               (e)  Electronic fetal monitoring equipment;

               (f)  Infant scale;

               (g)  Sterile suturing equipment and supplies;

               (h)  Log book for registration of birth that contains the following information:

 

                      (i)      Mother's name;

                      (ii)     Client medical record number;

                      (iii)    Date of delivery;

                      (iv)    Time of delivery;

                      (v)     Mother's age;

                      (vi)    Gravida, Para;

                      (vii)    Newborn weight;

                      (viii)   Newborn sex;

                      (ix)    Gestational age;

                      (x)     Transport information:

 

                                  1)  Mother;

                                  2)  Baby;

                                  3)  Where;

                                  4)  When; and

                                  5)  By whom;

 

                      (xi)    Death information:

 

                                  1)  Neonatal;

                                  2)  Maternal; or

                                  3)  Stillbirth;

 

                      (xii)  Type of delivery;

                      (xiii)  Condition of newborn at delivery/congenital anomalies;

                      (xiv)  Delivering person; and

                      (xv)   APGAR score;

 

               (i)  Sphygmomanometer, stethoscope, and fetoscope; and

               (j)  Any other equipment necessary to provide full scope of service and to ensure safety of mother and newborn.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(3), (4), and (12).

          Law Implemented: SDCL 34-12-62(3), (4), and (12).

 

          44:69:05:04.  Clinical policies and procedures. Each birth center shall establish and maintain policies and procedures, and practices to govern care, and related medical or other services necessary to meet the client's needs. The nursing service of the birth center shall provide safe and effective care through ongoing assessment and monitoring for each client and newborn, including medical, physical, mental, and emotional needs. The birth center shall establish and implement procedures for assessment and management of symptoms including pain. The policies shall include the following:

 

          (1)  Client eligibility criteria, including detailed definitions of screening criteria for, and procedures for identifying:

 

               (a)  Low-risk maternal clients who shall be eligible for birth services offered by the birth center;

               (b)  Persons who shall be ineligible for birth services at the birth center;

 

          (2)  Written plans and procedures for consultation, backup services, transfer and transport of a newborn or maternal client to a hospital where appropriate care is available;

 

          (3)  Policies and procedures developed for routine and for emergency care of both the maternal and the fetus or newborn client until completion of care by the birth center either through completion of the care program or through transfer to other levels of care;

 

          (4)  Written evidence of the availability of emergency transport services for clients;

 

          (5)  Staffing competency criteria;

 

          (6)  Provision for the education, orientation and training of clients, family and support persons in pregnancy, childbirth, and newborn care;

 

          (7)  Procedures for the registration of births and the examination for and the reporting of congenital physical and mental impairments in infants;

 

          (8)  Prophylactic treatment of the eyes of the newborn as required by SDCL chapter 34-24;

 

          (9)  Testing for metabolic diseases as required by SDCL chapter 34-24;

 

          (10)  Informed consent and disclosure requirements;

 

          (11)  Client care for the mother and newborn, including criteria for monitoring and assessment during all stages of labor and delivery;

 

          (12)  Transport protocols and physician referral protocols;

 

          (13)  Discharge criteria for mother and newborn, to include information on and access to client follow-up care;

 

          (14)  Assigning the nursing care of clients and newborns;

 

          (15)  Client rights policies;

 

          (16)  Administration and control of medications;

 

          (17)  Charting by nursing personnel;

 

          (18)  Quality assurance;

 

          (19)  Infection control, including cleaning, laundry, scrub area criteria, decontamination, disinfection, sterilization, storage of sterile supplies, storage of soiled products, and disposal of medical waste;

 

          (20)  Emergency and disaster plans;

 

          (21)  Birth center safety, including fire safety and construction;

 

          (22)  Emergency equipment and procedures to provide emergency care;

 

          (23)  Birth center operational functions;

 

          (24)  Medical record contents, noting of diagnostic and therapeutic orders; and

 

          (25)  Client and newborn safety, to include client and newborn identity and security measures.

 

          Source: 38 SDR 115, effective January 9, 2012.

          General Authority: SDCL 34-12-62(1), (2), (3), (4), (7), (8), (9), (10), (11), and (12).

          Law Implemented: SDCL 34-12-62(1), (2), (3), (4), (7), (8), (9), (10), (11), and (12).

 

          44:69:05:05.  Client plans and programs. The practitioner service of a birth center shall provide safe and effective care from the day of admission through the ongoing development and implementation of written plans for each client and newborn. The client plan shall address medical, physical, mental, and emotional needs of the client and infant.

 

          The client plan for birth center clients shall be based on the nursing admission assessment and approved by the client's attending physician or certified nurse midwife. The client plan shall describe the services necessary to meet the client's medical, physical, mental or cognitive, nursing, and psychosocial needs and shall contain objectives and timetables to attain and maintain the highest level of functioning of the client. The client plan shall be completed upon admission and the birth of the infant.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(12).

          Law Implemented: SDCL 34-12-62(12).

 

          44:69:05:06.  Medical records. The birth center shall maintain a separate medical record for each client and newborn in accordance with acceptable professional standards for the purpose of continuity and evaluation of care, and preservation as a legal document.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(4).

          Law Implemented: SDCL 34-12-62(4).

 

          44:69:06:01.  Medical orders in birth centers. For each birth center with three or more beds, all medical orders shall be in writing and signed by a physician or certified nurse midwife. Telephone orders may be taken only when there is an urgent need to initiate or change a medical order. The physician or certified nurse midwife shall authenticate all verbal and telephone order with a date, time, and signature on the next visit to the birth center. Each client's physician or certified nurse midwife is responsible for documenting electronic or written orders and progress notes on each client's medical record.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(4) and (9).

          Law Implemented: SDCL 34-12-62(4) and (9).

 

          44:69:07:01.  Pharmaceutical services. The requirements for pharmaceutical services in birth centers include the following:

 

          (1)  There shall be written orders signed by a practitioner legally authorized to prescribe for all drugs administered to mother and infant within the birth center;

 

          (2)  There shall be policies and procedures addressing the receiving, transcribing, issuance, storage, control, accountability, administration, and disposal of medications or drugs in each birth center;

 

          (3)  Each birth center shall keep a list of the following in the drug storage area for reference:

 

               (a)  Generic and trade names for drugs substituted within the birth center;

               (b)  Drugs with unique requirements for administration used within the birth center, including enteric coatings, sublingual, buccal, and sustained release dosage forms; and

               (c)  Drugs controlled under SDCL chapter 34-20B that are used within the birth center;

 

          (4)  Written policies shall be established addressing the type and intended use of any drug to be used by clients within the birth center;

 

          (5)  Drugs, medications, biologicals, and chemicals kept in the birth center shall be labeled with the drug name, strength, and expiration date;

 

          (6)  Drug cabinets shall be accessible only to the nurse in charge, the practitioner, or the pharmacist. All drugs controlled pursuant to SDCL chapter 34-20B shall be kept in a securely locked box, accessible only to the nurse in charge, the practitioner, or the pharmacist;

 

          (7)  Each birth center having narcotics shall maintain a narcotic administration record so the disposition of any particular controlled substance can be readily traced. The date, time administered, name of administering practitioner or nurse, the name and strength of the narcotic, the name of the client, and the balance remaining shall be documented in the record;

 

          (8)  Drugs may not be stored in a refrigerator used for food storage for clients, families, and employees;

 

          (9)  Anesthetic agents and techniques to be used in any birth center shall be determined by its governing board;

 

          (10)  General and conduction anesthesia may not be administered at the birth center. Local anesthesia for pudendal block and episiotomy repair may be performed if procedures are outlined by the clinical staff. Systemic analgesia may be administered but pain control should depend primarily on close emotional support and adequate preparation for the birth experience;

 

          (11)  Drugs shall be administered only by personnel or staff licensed to administer drugs;

 

          (12)  The birth center shall be in conformance with any applicable federal, state, and local laws and regulations relating to drug and to controlled substances;

 

          (13)  A physician, pharmacist, or certified nurse midwife shall be responsible for the supervision of drug stocks in the birth center; and

 

          (14)  Self-administration of medications may not be permitted by clients admitted to the birth center.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:02.  Written orders for medication required. All medications or drugs administered to clients shall be ordered in writing and signed by the prescribing practitioner. Telephone 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, licensed nurse, or certified nurse midwife in the birth center. The practitioner shall sign or initial the orders for birth center clients on the next visit to the birth center.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:03.  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 individuals, clients, or visitors at all times.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:04.  Control and accountability of medications and drugs. Medications brought from home may be used if ordered by the attending practitioner and, if prior to administration, is identified as the prescribed drug.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:07:05.  Documentation of drug disposal. If a birth center has a licensed pharmacy, outdated or discontinued medications shall be returned to the pharmacy for disposition. In the absence of a licensed pharmacy, the method of disposition of outdated or discontinued medications shall be handled and recorded in the client's medical record as follows:

 

          (1)  Legend drugs not controlled under SDCL chapter 34-20B shall be destroyed by a nurse and another witness;

 

          (2)  Destruction or disposal of medications controlled under SDCL chapter 34-20B shall be witnessed by two persons, both of whom are either a nurse, certified nurse midwife, or pharmacist, as designed by facility policy; and

 

          (3)  Medications, excluding controlled substances listed in SDCL chapter 34-20B, in unit dose packaging that meets packaging standards in § 20:51:13:02.01 may be returned to the pharmacy pursuant to § 20:51:13:02.01.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(8).

          Law Implemented: SDCL 34-12-62(8).

 

          44:69:08:01.  Application of chapter. This chapter applies to all birth centers and to renovations, additions, and changes in space use of currently approved existing birth centers. Accessible and usable accommodations shall be available to the public, staff, and clients with disabilities. Minimum requirements, except as noted in this chapter, are those in the "2010 ADA Standards of Accessible Design", Department of Justice, September 15, 2010.

 

          Each birth center shall comply with NFPA 101 Life Safety Code, 2009 edition. Each birth center shall also comply with the building construction standards of the International Building Code, 2009 edition. Each birth center with two or fewer beds shall meet the provisions of Lodging and Rooming Houses in the Life Safety Code. Each birth center with three or more beds shall meet New Health Care Occupancies in the Life Safety Code.

 

          An automatic sprinkler system is not required for a birth center with two or fewer beds. For each birth center with two or fewer beds, a 2-A:10-B:C fire extinguisher shall be provided on each level.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-1-17(4), 34-12-62(1), (5), (6), and (13).

          Law Implemented: SDCL 34-12-62(1), (5), (6), and (13).

 

          References: "2010 ADA Standards for Accessible Design, Department of Justice", September 15, 2010. Copies may be obtained from the Rocky Mountain Disability and Business Technical Assistance Center, Colorado Springs, CO 80907. Phone: 1-800-949-4232. Cost: $15.

 

          NFPA 101 Life Safety Code, 2009 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: $76.50.

 

          International Building Code, 2009 edition. Copies may be obtained from International Conference of Building Officials, Phone 1-800-786-4452. Order@iccsafe.org. Cost: $85.50.

 

          44:69:08:02.  Submittal of plans. No construction may begin until plans and specifications covering the construction of new buildings and additions or material alterations to existing buildings are approved by the department. A written narrative describing the intended use of the proposed construction shall accompany the plans and specifications.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(1), (5), (6), and (13).

          Law Implemented: SDCL 34-12-62(1), (5), (6), and (13).

 

          44:69:08:03.  Birth rooms for birth centers with two or fewer beds. Each birth room in a birth center with two or fewer beds shall meet the following requirements:

 

          (1)  Each birth room shall be a minimum of 120 square feet (10.05 square meters) including the newborn area;

 

          (2)  At least one birth room shall be wheelchair accessible;

 

          (3)  Each birth room shall have an egress window to the outside;

 

          (4)  A work station and handwashing sink shall be in close proximity to each birth room. Handwashing facilities shall be equipped with hands-free controls and have a water supply spout mounted so that the discharge is a minimum five inches above the rim of the fixture;

 

          (5)  Each birth room shall be equipped with battery operated emergency lighting and protective lamp covers; and

 

          (6)  Each birth room shall have available oxygen and suction. Use of portable equipment is permitted.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(1) and (5).

          Law Implemented: SDCL 34-12-62(1) and (5).

 

          44:69:08:04.  Birth rooms for birth centers with three or more beds. Each birth room in a birth center with three or more beds shall meet the following requirements:

 

          (1)  Each birth room shall be a minimum of 200 square feet (18.40 square meters) including the newborn area;

 

          (2)  Each birth room shall be equipped with a handwashing station with hands-free operators;

 

          (3)  Each birth room shall have direct access to a private bathroom equipped with a handwashing sink, toilet, and shower or tub;

 

          (4)  Each birth room shall be equipped with a vinyl floor surface;

 

          (5)  Each birth room shall have adequate lighting with protective covers to prevent lamp from shattering;

 

          (6)  Each birth room shall be equipped with battery operated emergency lighting;

 

          (7)  Each birth room shall be located to ensure privacy during occupancy for labor, birth, and postpartum care until discharge from the center;

 

          (8)  Each birth room shall be located out of the path of traffic and under direct supervision of birth center staff;

 

          (9)  Each birth room shall have available oxygen and suction. Use of portable equipment is permitted;

 

          (10)  Each birth room shall be provided with subdued indirect lighting and special lighting capable of providing at least 700 foot-candles in the delivery and newborn care area; and

 

          (11)  If an elevator is provided, the elevator shall be equipped with a cab with a minimum dimensions of five feet eight inches wide by seven feet six inches deep (1.73 meters wide by 2.29 meters deep).

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(1) and (5).

          Law Implemented: SDCL 34-12-62(1) and (5).

 

          44:69:08:05.  Services area in care area for birth centers with three or more beds. Each birth center with three or more beds shall contain a service area that includes the following:

 

          (1)  Office space shall be located in the birth center unless the provider's professional office is attached;

 

          (2)  A reception and administration area shall be located to control and monitor access to the birth center;

 

          (3)  A staff work area with counter and storage;

 

          (4)  A medication preparation room with work counter, counter sink, lockable refrigerator, and locked storage for medications;

 

          (5)  A nourishment area with a work counter, counter sink, refrigerator, storage cabinets, and equipment for hot and cold nourishment;

 

          (6)  Each center shall have equipment to provide ice for treatment and nourishment;

 

          (7)  A clean workroom shall be separate from and have no direct connection with soiled workrooms or soiled holding rooms and shall be equipped with a work counter, hand-washing station, and storage for clean and sterile supplies and equipment;

 

          (8)  A soiled workroom shall contain a clinical sink, hand-washing station, and work counter and space to separate covered containers for soiled linen and a variety of waste types;

 

          (9)  An environmental services room shall be provided for the exclusive uses of the birth center;

 

          (10)  A staff lounge;

 

          (11)  Securable lockers, closets, and cabinets compartments for the personal articles for staff shall be provided near the staff work areas;

 

          (12)  At least 20 square feet (1.86 square meters) of general storage shall be provided for each birth room; and

 

          (13)  Corridors shall have a width of at least five feet (1.52 meters).

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(1) and (13).

          Law Implemented: SDCL 34-12-62(1) and (13).

 

          44:69:08:07.  Plumbing. A birth center's plumbing system 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 birth center. Plumbing may not constitute a source of contamination of food equipment or utensils or create an unsanitary condition or nuisance.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(1), (6), and (13).

          Law Implemented: SDCL 34-12-62(1), (6), and (13)

 

          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.

 

          44:69:08:08.  Ventilation. Electrically powered exhaust ventilation shall be provided in all soiled areas, wet areas, and toilet rooms. Clean storage rooms may also be ventilated by supplying and returning air from the building's air-handling system.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(1) and (13).

          Law Implemented: SDCL 34-12-62(1) and (13).

 

          44:69:08:09.  Heating and cooling. The temperature in any occupied space in the birth center shall be maintained between 68 and 80 degrees Fahrenheit during waking hours and not lower than 64 degrees Fahrenheit during sleeping hours. A client's room may be maintained outside the required range if desired by the client.

 

          Source: 38 SDR 115, effective January 9, 2011.

          General Authority: SDCL 34-12-62(1) and (13).

          Law Implemented: SDCL 34-12-62(1) and (13).