Administrative Rule 44:67:04 | South Dakota Legislature

This medication can be taken up to 9 weeks after conception. The woman is given Mifepristone to be taken by mouth. After a period of time in the doctor's office, she may return home. At 24 - 72 hours after this dose, the woman returns to receive the proper amount of misoprostol.

The client should then be watched closely by doctors and nurses for a few hours. The fetus, placenta and membranes are usually expelled during this time. The woman should return to the doctor's office on the 14th day after taking the medication to assure that there are no problems and that the fetus, placenta and membranes have been fully expelled.

On [date], at [time of day), I,

[signature of pregnant woman], certify that I read and I understand the above disclosures on this page.

Any clarifications, explanations, or answers to my questions were provided to me in writing to my satisfaction.

Page 3

Discontinuation of Drug Induced Abortion

Even after a pregnant mother takes Mifepristone, or another drug approved by the United States Food and Drug Administration for the same use, it is still possible to discontinue a drug- induced abortion by not taking the prescribed Misoprostol. Information is available on the Department of Health website http://doh.sd.gov/abortion/. For more specific information, please contact your physician or medical provider.

On [date], at [time of day), I,

[signature of pregnant woman], certify that I read and I understand the above disclosures on this page.

Any clarifications, explanations, or answers to my questions were provided to me in writing to my satisfaction.

Page 4

1-g) The statistically significant medical risk associated with carrying her child to term compared to undergoing an induced abortion ― In an otherwise healthy woman, carrying a baby to term is usually a safe, healthy process for the mother. Based on data from the CDC, the following are some common maternal health conditions or problems a woman may experience during pregnancy: anemia, urinary tract infections, depression, hypertension, diabetes, obesity, infections, and Hyperemesis Gravidarum (a severe form of nausea and vomiting in pregnancy). To compare those risks to the risks of abortion, please refer to 1-e above, which sets out the risk factors presented by abortion to the mother. In regards to the unborn child, the abortion will terminate the life of a whole, separate, unique living human being. On the other hand, although every pregnancy has some risk of problems, continuing a pregnancy and delivering a baby is usually a safe and healthy process for an otherwise healthy woman.

On [date], at [time of day), I,

[signature of pregnant woman], certify that I read and I understand the above disclosures on this page.

Any clarifications, explanations, or answers to my questions were provided to me in writing to my satisfaction.

Page 10

1-j) Sex-selective abortions. Sex-selective abortions are illegal in the State of South Dakota and you as a pregnant mother cannot have an abortion, either solely or partly, due to the unborn child's sex, regardless of whether that unborn child is a girl or a boy or whether it is of your free will as the pregnant mother, or the result of the use of pressure and coercion.

1-k) Sex Trafficking. The abortion facility is required to provide the name, text, and telephone number of an organization fighting to end sex trafficking. By signing this document, you understand help is available and you have been provided the information above on how and where to get help.

On [date], at [time of day), I,

[signature of pregnant woman], certify that I read and I understand the above disclosures in compliance with SDCL § 34-23A-10.1.

Any clarifications, explanations, or answers to my questions were provided to me in writing to my satisfaction.

Rule 44:67:04:01 Nursing services.

44:67:04:01. Nursing services. Each abortion 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 abortion facility at all times when an abortion procedure 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.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(2).

Rule 44:67:04:02 Employee health program.

44:67:04:02. Employee health program. The abortion 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 tuberculin skin tests. 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. 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 or the physician's designee to no longer have the disease in a communicable stage.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(6).

Cross-Reference: Definition of terms, § 44:20:01:01(7) and (39).

Rule 44:67:04:03 Tuberculin screening requirements.

44:67:04:03. Tuberculin screening requirements. Each abortion facility shall comply with the provisions of § 44:04:04:08.01.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(6).

Rule 44:67:04:04 Personnel training.

44:67:04:04. Personnel training. The abortion 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;

(2) Emergency procedures and preparedness;

(3) Infection control and prevention;

(4) Accident prevention and safety procedures;

(5) Patient rights;

(6) Confidentiality of patient information;

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

(8) Care of patients with unique needs; and

(9) Clinic policies and procedures.

Personnel whom the abortion facility determines will have no contact with patients are exempt from training required by subdivisions (5) and (8) of this section.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(1),(2),(6),(8),(9),(11).

Rule 44:67:04:05 Clinic policies and procedures.

44:67:04:05. Clinic policies and procedures. Each abortion facility shall establish and maintain policies, procedures, and practices to govern care, and related medical or other services necessary to meet the patient's needs. The nursing service of an abortion clinic shall provide safe and effective care through the ongoing assessment and monitoring for each patient, including medical, physical, mental, and emotional needs. The abortion facility shall establish and implement procedures for assessment and management of symptoms including pain.

Policies and procedures must include:

(1) Patient eligibility criteria;

(2) Physician competency criteria;

(3) Patient education and informed consent;

(4) Clinic operational functions;

(5) Patient care, including criteria for monitoring and assessment during recovery; care during the recovery phase; and criteria for discharge;

(6) Patient rights policies; and

(7) Emergency and disaster plans.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(3),(10),(11).

Rule 44:67:04:06 Discharge planning.

44:67:04:06. Discharge planning. Each abortion facility shall have policies and procedures for discharge planning including the person responsible, members of the discharge planning team, a list of area agencies and resources, and a description of the process. Patients shall be offered assistance to obtain needed services upon discharge.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(10).

Rule 44:67:04:07 Emergency care.

44:67:04:07. Emergency care. Each abortion facility 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 facility's patients if needed. The policies and procedures must provide for an interchange of medical and other information necessary or useful in the care and treatment of individuals transferred between the facilities.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(3).

Rule 44:67:04:08 Medical records.

44:67:04:08. Medical records. A medical record shall be maintained for each abortion procedure in an abortion facility in conformance with chapter 44:04:09.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(4).

Rule 44:67:04:09 Pharmaceutical services.

44:67:04:09. Pharmaceutical services. The requirements for pharmaceutical services in abortion facilities centers are as follows:

(1) A physician or a pharmacist shall be 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 the nurse in charge, the physician, 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, physician, or the pharmacist.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(7).

Rule 44:67:04:10 Quality assessment.

44:67:04:10. Quality assessment. Each abortion facility shall provide for on-going evaluation of the quality of services provided to patients. 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: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(8),(10).

Rule 44:67:04:11 Laboratory services.

44:67:04:11. Laboratory services. Clinical laboratory tests consistent with the needs of the patients shall be provided or performed by arrangement. The laboratory shall hold a valid Clinical Laboratory Improvement Amendment (CLIA) certificate and comply with CLIA regulations if testing is done onsite. Laboratory tests required on each patient shall be determined by the medical staff and bylaws. The original laboratory report shall be made a part of the patient's medical records. Fire and safety precautions shall be enforced to protect against physical, chemical, and biological hazards peculiar to the laboratory.

Source: 33 SDR 107, effective December 26, 2006.

General Authority: SDCL 34-23A-51.

Law Implemented: SDCL 34-23A-51(9).

Note: CLIA applications are obtained from the South Dakota Department of Health, Office of Licensure and Certification, 615 East 4^th Street, Pierre, SD 57501. Telephone: (605) 773-3356 or www.hhs/cms/clia.

Rule 44:67:04:12 Required informed consent form.

44:67:04:12. Required informed consent form. To meet the requirements of SDCL subdivision 34-23A-10.1(1), the physician shall use the informed consent form provided in Appendix A.

Source: 46 SDR 65, effective November 26, 2019.

General Authority: SDCL 34-23A-10.5.

Law Implemented: SDCL 34-23A-10.1(1), 34-23A-10.5.

44:67:04:13. Mifepristone and Misoprostol administration for medical abortion. For the purpose of inducing a medical abortion, a pregnant woman may only take the medications Mifepristone or Misoprostol up to nine weeks after conception. Mifepristone and Misoprostol must be prescribed and dispensed by a licensed physician in a licensed abortion facility consistent with SDCL chapter 34-23A and in compliance with the applicable requirements in SDCL chapter 36-4. A pregnant woman may only take Mifepristone at a licensed abortion facility and only after informed consent has been obtained pursuant to SDCL 34-23A-l0.1 and consistent with SDCL 34-23A-56. Before dispensing Mifepristone. a physician shall provide the notice required by SDCL 34-23Al0.l(l)(h) and 34-23A-l0.1(3) ensuring that the pregnant woman has notice that if she changes her mind about the medical abortion and decides to carry the baby to term, it is possible to reverse the effects of Mifepristone. After taking Mifepristone and undergoing an observation period in the abortion facility, the pregnant woman may return home. Between 24-72 hours after taking Mifepristone, if the pregnant woman decides to continue with the medical abortion, the pregnant woman must return to the licensed abortion facility to receive the proper amount of Misoprostol. A licensed physician shall dispense the Misoprostol to the pregnant woman in the same manner as required for Mifepristone under this section. Neither Mifepristone nor Misoprostol may be dispensed for the purpose of inducing a medical abortion in any manner contrary to this section. The abortion facility staff shall monitor the pregnant woman for complications for a medically necessary period following each administration of the abortion-inducing medications and report the following information to the Department of Health:

(1) Any complication that requires medical follow-up;

(2) The medical follow-up that was required resulting from any complication;

(3) The facility where the medical follow-up was performed; and

(4) If the pregnant woman was sex trafficked.

The abortion facility staff shall schedule a follow-up appointment with the pregnant woman to return to the abortion facility on the 14th day after taking the medication to confirm that the fetus, placenta, and membranes have been fully expelled.

For the purposes of this section, the term, medical abortion, means a procedure that uses medication to end a pregnancy.

Source: 48 SDR 75, effective January 27, 2022.

General Authority: SDCL 34-23A-51(7)(10)(11).

Law Implemented: SDCL 34-23A-10.1(3), 34-23A-19, 34-23A-56.

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