216-RICR-20-10-6. Termination of Pregnancy

216-RICR-20-10-6 TITLE 216 - DEPARTMENT OF HEALTH CHAPTER 20 - COMMUNITY HEALTH SUB CHAPTER 10 - SCREENING, MEDICAL SERVICES AND REPORTING PART 6 - Termination of Pregnancy 6.1 Authority These rules and regulations are promulgated pursuant to the authority set forth in R.I. Gen. Laws § 23-1-1 for the purpose of safeguarding the health, safety, and welfare of women undergoing a termination of pregnancy. 6.2 Definitions A. Wherever used in these regulations, the following terms shall be construed as follows: 1. "Fetal death", as defined in R.I. Gen. Laws § 23-3-1(3), means death prior to the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy; the death is indicated by the fact that after such expulsion or extraction the fetus does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of the voluntary muscles. 2. “Gestation” means the duration of the pregnancy computed from the first day of the last menstrual period, or based upon clinical judgment of the examining physician (or other licensed health care practitioner acting within his/her scope of practice) when that date is unreliable. 3. "Gestational age" means the estimated age of the fetus based upon anatomical characteristics of the fetus. 4. “Physician” means a person authorized or licensed to practice medicine or osteopathy pursuant to R.I. Gen. Laws § 5-37. 5. "R.I. Gen. Laws" means Rhode Island General Laws, as amended. 6. "Termination of a pregnancy" or "Termination" shall mean administering to a woman any medicine, drug, substance, or thing whatever, or the employment upon her of any instrument or other means whatever, with intent to procure or induce the miscarriage of such woman. (The term "abortion" is not used in these regulations, since it applies to both spontaneous and induced fetal loss). 6.3 Requirements for Pregnancy Terminations 6.3.1 General Provisions A. Pursuant to the provisions of R.I. Gen. Laws § 23-1-19, the Director of Health is authorized to enter, examine or survey at any reasonable time such places as he/she considers necessary, which perform the services of these rules and regulations. B. Prior to the end of the fourteenth (14th) week of gestation (counted from the first day of the last normal menses), termination of pregnancy may be performed outside the hospital or freestanding ambulatory surgical center, when hospital emergency back-up services are available and other provisions of these regulations are observed. C. From the beginning of the fifteenth (15th) week of gestation through the end of the eighteenth (18th) week of gestation (counted from the first day of the last normal menses), termination procedures utilizing surgical techniques or methods shall be performed only in a licensed hospital, licensed freestanding ambulatory surgical center, licensed physician office setting providing surgical treatment (“office operatory”), and/or in an outpatient setting meeting the criteria required for a freestanding surgical facility, and in accordance with other provisions of these rules and regulations. D. After the beginning of the nineteenth (19th) week of gestation (counted from the first day of the last normal menses), a procedure utilizing surgical techniques or methods shall be performed in a hospital, and/or a licensed freestanding ambulatory surgical center. Provided, however, consistent with the provisions of R.I. Gen. Laws § 11-23-5, the procedure shall be performed in the final trimester only when necessary to preserve the life or health of the mother. E. A patient shall not be compelled to undergo, a physician or other licensed health care practitioner acting within his/her scope of practice shall not be compelled to perform, or a person shall not be compelled to assist at, termination of pregnancy. F. The principles for a signed statement of "informed consent", including an operative permit as required for other medical-surgical procedures, shall apply. 6.3.2 Requirements for Facilities Using Surgical Techniques or Methods A. Where inhalation anesthesia is utilized, a licensed freestanding ambulatory surgical center or a licensed physician office setting providing surgical treatment (“office operatory”) shall comply with the safety standards cited in Part 40-10-5 of this Title, the Rules and Regulations for Licensing of Freestanding Ambulatory Surgical Centers; a hospital shall comply with the safety standards cited in Part 40-10-4 of this Title, the Rules and Regulations for Licensing of Hospitals. B. Furthermore all facilities utilizing surgical techniques or methods shall provide the following: 1. Facilities for registration, interviewing, counseling, history taking, medical evaluation and examination, equipped with suitable furnishings and accommodations, including waiting and dressing rooms and other appurtenances for the privacy, physical comfort and convenience of patients and personnel; 2. An adequately staffed and equipped procedure room(s) sufficient in number and size to accommodate expected caseload, personnel and equipment including the following: a. Dressing room and scrub-up facilities suitably located to procedure room(s); b. Utility room with facilities for sterilization of supplies, except when sterile supplies are received from a central supply service; c. All necessary instruments and supplies for the performance of appropriate surgical procedure; d. All necessary equipment for resuscitation and emergency treatment of complications (e.g., hemorrhage, cardiac arrest, shock, anaphylactic reactions and respiratory complications); e. An adequate supply of drugs, Rh immune globulin, electrolyte solutions and plasma volume expanders, immediately available at all times for emergency use; and f. Environmental controls for the protection of the health, safety and welfare of patients and personnel. 3. A recovery room(s) adequate in size and appropriately equipped and staffed in which the patient(s) will be observed until sufficiently recovered from the procedure and the anesthesia and can be safety discharged by the physician or other licensed health care practitioner acting within his/her scope of practice. 4. Provisions shall be made for the prompt and safe transfer of patients for the back-up services referred to in §§ 6.3.1(B) and 6.3.1(C) of this Part. 5. Facilities not on the ground floor shall be served by an elevator capable of accommodating a standard stretcher. 6. Space and equipment shall be provided to permit the production, storage, retrieval and reproduction of records. 6.3.3 Program Requirements A. Provisions shall be made for the protection of the dignity, privacy and emotional concerns of the patient in a safe, considerate atmosphere. B. All indicated counseling services shall be made available to patients for the prevention and management of personal problems before and after a termination procedure. C. Verification of the diagnosis and duration of pregnancy and a medical history shall be obtained and a complete physical examination performed, including pelvic examination, with consideration of any medical, surgical or psychiatric conditions requiring special attention. D. No less than the following laboratory procedures shall be conducted on each patient and reports shall be available prior to the performance of termination of pregnancy procedure: (1) pregnancy test; (2) hemoglobin or hematocrit; (3) blood and Rh typing; and (4) urinalysis. 1. Other laboratory procedures such as Papanicolaou smear, and tests for sexually transmitted diseases should be conducted in accordance with standard medical practice. E. A medical record shall be established and maintained for each patient and shall contain no less than the following items: 1. Reports of observations cited in § 6.3.3(C) of this Part; 2. Laboratory findings; 3. Plan of management, including reasons for termination of pregnancy, and procedure to be employed; 4. All observations of patient's condition during procedure and recovery; and 5. Discharge, follow-up, and referral plans. F. All tissue removed shall be considered as surgical specimens and shall be submitted for pathological examination and the report included in the patient record. Furthermore, for any termination after the eleventh (11th) week of gestation, the gestational age of the fetus shall be determined in accordance with current standards of medical practice. G. Provisions shall be made for patient access to family planning services, including referral to specialized agencies. H. Rh immune globulin shall be administered to every unsensitized Rh(d) negative woman who has a termination of pregnancy. 6.3.4 Personnel Requirements A. All termination procedures shall be performed only by a physician licensed under the provisions of R.I. Gen. Laws § 5-37, or other licensed health care practitioner acting within his/her scope of practice, provided, however, surgical terminations shall only be performed by a physician. B. There shall be sufficient personnel to carry out all required functions including reception, counseling, pre- and post-operative nursing care, clerical work, housekeeping and maintenance. C. Anesthesia shall be administered in accordance with 216-RICR-40-10-5, the Rules and Regulations for Licensing of Freestanding Ambulatory Surgical Centers or 216-RICR-40-10-4, the Rules and Regulations for Licensing of Hospitals as appropriate to the category of facility where the termination of pregnancy is performed. 6.4 Reporting and Severability 6.4.1 Reporting Requirements A. All live births, and all fetal deaths after 20 weeks of gestation, shall be reported in accordance with the current requirements of R.I. Gen. Laws § 23-3-17 entitled “Fetal Death Registration.” B. All fetal deaths, whether induced as consequence of a termination procedure or by spontaneous abortion shall be reported in accordance with R.I. Gen. Laws § 23-3-17(b), which reads, "All other fetal deaths, irrespective of the number of weeks uterogestation, shall be reported directly to the state Department of Health within seven (7) calendar days after delivery." Such reporting shall be made on authorized forms provided by the Department of Health. 6.4.2 Severability If any provision of these regulations or the application thereof to any facility or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end, the provisions of the regulations are declared to be severable. 216-RICR-20-10-6 TITLE 216 - DEPARTMENT OF HEALTH CHAPTER 20 - COMMUNITY HEALTH SUBCHAPTER 10 - SCREENING, MEDICAL SERVICES, AND REPORTING PART 6 - TERMINATION OF PREGNANCY (216-RICR-20-10-6) Type of Filing: Repeal Agency Signature _________________________________________________________________ Agency Head Signature Agency Signing Date Department of State ____________________________ Regulation Effective Date _________________________________________________________________ Department of State Initials Department of State Date 07/13/2023 June 23, 2023 E-SIGNED by Sandra Powell on 2023-06-23 13:09:56 EDT June 23, 2023 E-SIGNED by Department of State on 2023-06-23 15:15:12 EDT