216-RICR-20-10-6
216-RICR-20-10-6. Termination of Pregnancy (version Technical Revision, 01/02/2002 to 01/04/2022)
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.