Current through Register Vol. 49, No. 9, September, 2024
SECTION
3.
DEFINITIONS.
Note: see Section 12 for additional definitions for
Physical Facilities requirements
A.
1.
Abortion - the act of using or prescribing any instrument,
medicine, drug, or other substance, device, or means with the intent to
terminate the clinically diagnosable pregnancy of a woman with knowledge that
the termination by those means will with reasonable likelihood cause the death
of the unborn child.
2. An act
under paragraph (A)(1) above is not an abortion if the act is performed with
the intent to:
a. save the life or preserve
the health of the unborn child;
b.
remove a dead unborn child caused by a spontaneous abortion; or
c. remove an ectopic pregnancy.
Note: Abortions are prohibited during and after
the twentieth (20) week of a woman's pregnancy except as authorized by law. See
Ark. Code Ann. §
20-16-1405;
B.
Abortion Complication - any
harmful event or adverse outcome with respect to a patient related to an
abortion that is performed on the patient and that is diagnosed or treated by a
physician or at a healthcare facility, including but not limited to shock,
uterine perforation, cervical laceration, hemorrhage, aspiration or allergic
response, infection, sepsis, death, incomplete abortion, damage to the uterus,
and an infant born alive after an abortion.
C.
Abortion facility - A clinic,
health center, or other facility in which the pregnancies of ten (10) or more
women known to be pregnant are willfully terminated or aborted in any month,
including nonsurgical abortions.
D.
Abortion-inducing drug - a medicine, drug, or any other substance
prescribed or dispensed with the intent of terminating the clinically
diagnosable pregnancy of a woman with knowledge that the termination will with
reasonable likelihood cause the death of the unborn child.
1. "Abortion-inducing drugs" include
off-label use of drugs known to have abortion inducing properties, which are
prescribed specifically with the intent of causing an abortion, such as
misoprostol, Cytotec, and methotrexate.
2. This definition does not apply to drugs
that may be known to cause an abortion, but which are prescribed for other
medical indications such as chemotherapeutic agents or diagnostic
drugs.
3. Use of drugs to induce
abortion is also known as a medical, drug-induced, or chemical
abortion.
E.
Act - Act 509 of 1983 as amended by Act 1176 of 2011.
F.
Administrator - an individual
designated to provide daily supervision and administration of the Abortion
Facility.
G.
Adverse
event - an undesirable experience associated with the use of a medical
product in a patient, including without limitation an event that causes:
1. death;
2. threat to life;
3. hospitalization;
4. disability or permanent damage;
5. congenital anomaly or birth defect, or
both;
6. required intervention to
prevent permanent impairment or damage;
7. other serious important medical events,
including without limitation:
a. allergic
bronchospasm requiring treatment in an emergency room;
b. serious blood dyscrasias;
c. seizures or convulsions that do not result
in hospitalization; and
d. the
development of drug dependence or drug abuse.
H.
Born-alive infant - the
complete expulsion or extraction of an infant from a mother, regardless of the
state of gestational development, who shows any evidence of life, including
without limitation:
1. breathing;
2. heartbeat;
3. umbilical cord pulsation; or
4. definite movement of voluntary
muscles.
I.
Consent - a signed and witnessed voluntary agreement for the
performance of an abortion; or
1. in the case
of a pregnant woman who is less than eighteen (18) years of age, a notarized
written statement signed by the pregnant woman and her mother, father, or legal
guardian declaring that the pregnant woman intends to seek an abortion and that
her mother, father, or legal guardian consents to the abortion; or
2. in the case of a pregnant woman who is an
incompetent person, a notarized written statement signed by the pregnant
woman's guardian declaring that the guardian consents to the performance of an
abortion upon the pregnant woman.
J.
Dead fetus or fetal remains -
a product of human conception exclusive of its placenta or connective tissue,
which has suffered death prior to its complete expulsion or extraction from the
mother as established by the fact that, after the 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 voluntary
muscles.
K.
Department
- the Arkansas Department of Health.
M.
Division - the Division of
Health Facility Services.
N.
Director - the Chief Administrative Officer in the Division of
Health Facility Services.
O.
Emancipated minor means a person less than eighteen (18) years of
age who is or has been married or who has been legally emancipated.
P.
External member of the human body
means an arm or one (1) or more joints of the arm, a hand, a finger or
one (1) or more joints of the finger, a leg or one (1) or more joints of the
leg, a foot, a toe or one (1) or more joints of the toe, an ear or the greater
part of the ear, or the nose or the greater part of the nose.
Q.
Fertilization - the fusion of
a human spermatozoon with a human ovum.
R.
Final printed labeling - the
United States Food and Drug Administration ("USFDA") - approved informational
document for an abortion-inducing drug which outlines the protocol authorized
by the USFDA and agreed upon by the drug company applying for USFDA
authorization of that drug.
S.
General abortion facility - an abortion facility that provides
surgical abortions or both medical and surgical abortions.
T.
Hospital - Any acute care
facility established for the purpose of providing inpatient diagnostic care and
treatment.
U.
Gestational
age - the time that has elapsed since the first day of the woman's last
menstrual period.
V.
Human
tissue means any tissue of the human body, including without limitation
an external member of the human body, placenta, or fetal connective tissue.
W.
Incompetent person
means a person who has been adjudged a disabled person and has had a guardian
appointed for her.
X. Lethal fetal
anomaly means a fetal condition diagnosed before birth that will result in the
death of the unborn child with reasonable certainty within three (3) months of
the birth.
Y.
Local
anesthesia - Elimination or reduction of sensation, especially pain, in
one part of the body by topical application or local injection of a
drug.
Z.
Medical
abortion - a non-surgical abortion for which abortifacient
pharmaceutical drugs are used to induce the abortion.
AA.
Medical-only abortion
facility - an abortion facility in which no surgical abortions are
performed.
BB.
Minimal
sedation (anoxiolysis) - a drug-induced state during which patients
respond normally to verbal commands. Although cognitive function and physical
coordination may be impaired, airway reflexes, and ventilator and
cardiovascular functions are unaffected.
CC.
Minor means an individual
under eighteen (18) years of age.
DD.
Moderate sedation/analgesia
("Conscious Sedation") - a drug-induced depression of consciousness
during which patients respond purposefully to verbal commands, either alone or
accompanied by light tactile stimulation. No interventions are required to
maintain a patent airway, and spontaneous ventilation is adequate.
EE.
Parent means:
1. Either parent of the pregnant woman if
both parents are living;
2. One (1)
parent of the pregnant woman if only one (1) is living or if the second parent
cannot be located through reasonably diligent effort; or
3. The court-appointed guardian or custodian
if the pregnant woman has one.
FF.
Patient - any woman
receiving services in the facility and any born-alive infant.
GG.
Physician - a person
licensed to practice medicine in this state, including a medical doctor and a
doctor of osteopathy.
HH.
Post-fertilization age - the age of the unborn child as calculated
from the fertilization of the human ovum.
JJ.
Probable post-fertilization age of
the unborn child - what, in reasonable medical judgment, will, with
reasonable probability, be the post-fertilization age of the unborn child at
the time the abortion is planned to be performed or induced.
KK.
Reasonable medical judgment
- a medical judgment that would be made by a reasonably prudent physician
knowledgeable about the case and treatment possibilities with respect to the
medical conditions involved.
LL.
Respectful and proper manner means either releasing the human
tissue to the patient or authorized person, incineration, burial, or
cremation.
NN.
Surgical
abortion means a pregnancy is ended by surgically removing the contents
of the uterus through use of suction device or other instrument(s).
SECTION 4.
LICENSING.
A. Application for License. Application for a
license or renewal of a license shall be made on forms provided by the Arkansas
Department of Health. The application shall set forth:
1. The complete name and address of the
Abortion Facility
2. The facility
type:
a) General Abortion Facility;
or
b) Medical-Only Abortion
Facility; and
3.
Additional information as required by the Arkansas Department of
Health.
B. Grandfather
provisions.
1. A facility, in existence on
January 1, 2012 and in substantial compliance with the physical facility
requirements in Section 12, submitting initial application for licensure by
July 1, 2012 is exempted from the physical facility requirements in Section 12
of these Rules for its existing physical structure.
Notwithstanding this provision, a facility must be in
compliance with these rules after January 1, 2014, unless the modifications
would be impracticable.
2.
Except as otherwise provided in Section (4)(B)(1), Abortion Facilities shall
comply with all requirements set forth in these Rules and Regulations. The
Rules and Regulations shall become effective on January 1, 2012.
C. Availability of Emergency
Services. A General Abortion Facility shall be within thirty (30) miles of a
hospital which provides gynecological or surgical services.
D. Fee. Each application for initial
licensure of an Abortion Facility shall be accompanied by a fee of five hundred
dollars ($500). The fee shall be payable to the Arkansas Department of
Health.
E. Renewal of License. A
license, unless revoked, shall be renewable annually upon payment of a fee of
five hundred dollars ($500) to the Arkansas Department of Health accompanied by
an application for re-licensure. The application for annual license renewal
along with the fee shall be postmarked no later than January 2 of the year for
which the license is issued.
F.
Issuance of License. A license shall be issued only for the premises, services,
and person or persons reflected in the application. The license shall be posted
in a conspicuous place in the Abortion Facility. The license shall be effective
on a calendar year basis and shall expire on December 31 of each calendar year.
The license shall not be transferrable and shall expire if a change of
ownership occurs.
G. Change of
Ownership. It shall be the responsibility of the Abortion Facility to notify
the Division of Health Facility Services in writing at least thirty (30) days
prior to the effective date of a change of ownership. The following information
shall be submitted for review and approval:
1.
license application;
2. five
hundred dollars ($500) change of ownership fee; and
3. legal documents, ownership agreements, and
other information to support relicensure requirements.
H. Management Contract. It shall be the
responsibility of the Abortion Facility to notify the Division of Health
Facility Services in writing at least thirty (30) days prior to entering into a
management contract or agreement with an organization or firm. A copy of the
contract or agreement shall be submitted for review to assure the arrangement
does not affect the license status.
I. Closure. Once an Abortion Facility closes,
it shall no longer be considered licensed. The license issued to the Abortion
Facility shall be returned to the Division of Health Facility Services. To be
eligible for re-licensure, the Abortion Facility shall meet requirements for
new construction and all the current life safety and health
regulations.
J. Inspection. Any
authorized representative of the Arkansas Department of Health shall have the
right to enter upon or into the premises of any Abortion Facility at any time
in order to make whatever inspection it deems necessary in order to assure
minimum standards and regulations are met.
K. Denial, Suspension or Revocation. The
Department may deny, suspend or revoke the license of any Abortion Facility on
the following grounds: violation of any of the provisions of the Act or Rules
lawfully promulgated hereunder; and/or conduct or practices detrimental to the
health or safety of patients and employees of any such facilities. This
provision shall not be construed to have any reference to healing practices
authorized by law.
SECTION
5.
GOVERNING BODY.
An Abortion Facility shall have an organized Governing Body,
consisting of at least one (1) member, which may be the Medical Director, with
local representation which shall be legally responsible for maintaining patient
care and establishing policies for the facility and shall be legally
responsible for the conduct of the facility.
A. The Governing Body Bylaws. The Governing
Body shall adopt written bylaws which shall ensure the following:
1. Maintenance of professional standards of
practice;
2. Terms,
responsibilities and methods of selecting members and officers;
3. Methods by which Quality Improvement is
established; and
4. Compliance with
federal, state and local laws.
B. Governing Body Minutes. The Governing Body
minutes shall include at least the following information:
1. Review, approval and revision of the
Governing Body bylaws, rules, regulations and protocols;
2. Review and approval of the Quality
Improvement Plan for the facility at least annually, and review of Quality
Improvement summaries at least quarterly.
C. Quality Improvement (QI) Program.
1. The Abortion Facility shall develop,
implement, and maintain a QI program to include:
a) Collection of data on the functional
activities identified as priorities in QI and benchmark against past
performance and national or local standards; and
b) Development and implementation of
improvement plans for identified issues, with monitoring, evaluation and
documentation of effectiveness.
2. The scope of the QI Program shall include,
but not be limited to, activities regarding the following:
a) Assessment of processes and outcomes
utilizing facility-specific clinical data;
b) Evaluation of patient
satisfaction;
c) Evaluation of
staff performance according to facility protocols; and
d) Complaint resolution.
3. The facility shall evaluate the
effectiveness of the QI Program annually and establish priorities for the QI
Program.
SECTION
6.
GENERAL ADMINISTRATION.
A. Each facility shall have an Administrator
responsible for the management of the facility. The Medical Director may also
function as facility administrator.
B. Policies and procedures shall be provided
for the general administration of the facility and for each service. All
policies and procedures shall have evidence of ongoing review and/or revision.
The first page of each manual shall have the annual review date and signatures
of the person(s) conducting the review.
C. Provisions shall be made for safe storage
of patients' valuables.
D. Each
facility shall develop and maintain a written disaster plan which includes
provisions for complete evacuation of the facility. The plan shall provide for
widespread disasters as well as for a disaster occurring within the local
community or the facility. The disaster plan shall be rehearsed at least twice
a year. One (1) drill shall simulate a disaster of internal nature and the
other external. Written reports and evaluation of all drills shall be
maintained.
E. There shall be
posted a list of names, telephone numbers, and addresses available for
emergency use. The list shall include the key facility personnel and staff, the
local police department, the fire department, ambulance service, blood services
vendor, and other available emergency units. The list shall be reviewed and
updated at least every six (6) months.
F. There shall be current reference material
available onsite to meet the professional and technical needs of Abortion
Facility personnel including current books, periodicals, and other pertinent
materials.
G. All employees shall
be required to have annual in-services on safety, fire safety, back safety,
infection prevention and control, universal precautions, disaster preparedness
and confidential information.
H.
Procedures shall be developed for the retention and accessibility of the
patients' medical records if the Abortion Facility closes.
I. Any Abortion Facility that closes shall
meet the requirements for new construction in order to be eligible for
re-licensure. Once a facility closes, it is no longer licensed. The license
shall be immediately returned to Health Facility Services. To be eligible for
licensure, all the referenced National Fire Codes (NFPA) and health regulations
shall be met.
J.
1. Signed and witnessed written consent for
the performance of an induced abortion must be obtained and signed by the
patient prior to the abortion and after counseling by a qualified
professional.
2.
a.
In case of a minor, notarized written consent for the
performance of an induced abortion must be obtained and signed by both the
patient and the parent or legal guardian or custodian.
b. In case of a woman under legal
guardianship or custodianship for incompetency, notarized written consent for
the performance of an induced abortion must be obtained and signed by the
parent or legal guardian or custodian.
3. Written or verbal consent shall not
release the facility or its personnel from upholding the rights of patients
including, but not limited to, the right to privacy, dignity, security,
confidentiality, and freedom from abuse or neglect.
K. Each facility shall have a Medical
Director who shall be a physician currently licensed to practice medicine in
Arkansas, and who shall be responsible for the direct coordination of all
medical aspects of the facility program.
L. There shall be written policies and
procedures developed and approved by the Medical Director and Administrator
which define the care provided at the facility.
M. Policies and procedures shall include, but
not be limited to the following:
1. personnel
policies;
2. provision of medical
and clinical services;
3. provision
of laboratory services;
4.
examination of fetal tissue;
5.
disposition of medical waste;
6.
emergency services, including but not limited to:
a. written procedure for emergency transfer
to an acute care facility; and
b. a
medical record form that contains information required for an emergency
transfer to an acute care facility;
7. criteria for discharge;
8. health information systems (including
electronic records);
9. provision
of pharmacy services;
10.
medication administration;
11.
anesthesia/analgesia/sedation administration as applicable;
12. counseling services;
13. patient education;
14. infection prevention and
control;
15. fire, safety, and
disaster preparedness;
16.
housekeeping;
17.
laundry;
18. preventive
maintenance;
19. processing and/or
storage of sterile supplies;
20.
patient care;
a. pregnant and post-abortion
women clients; and
b. born-alive
infants;
21. probable
post-fertilization age determination;
22. proper disposition of dead fetuses and
fetal remains;
23. follow-up
appointments for medical abortion patients 12-18 days, or as recommended in the
final printed labeling, following abortion services, including administration
of abortion-inducing drugs;
24.
patient receipt of:
a. USFDA label(s) for
abortion-inducing drugs;
b. written
notice on reversing the effects of abortion-inducing drugs for patients
receiving such drugs as required by Act 522 of 2019;
25. ultrasound (abdominal) heartbeat
detection;
26. consent including
but not limited to items specified in §9 (B)(2);
27. child maltreatment and/or abuse
reporting; and
28. providing
printed materials and answering the woman's questions in a language that she
can understand;
29. pre-procedure;
and
30. process to insure that
perinatal palliative care information is provided to the mother of unborn child
diagnosed with lethal fetal anomaly 72 hours before the abortion as required by
Act 953 of 2019, the Perinatal Palliative Care Information
Act.
N. Administrative
Reports. The Administrator or his/her designee shall report:
1. Infectious or communicable diseases,
including sexually transmitted diseases, to the Arkansas Department of Health,
as required by:
a. the Rules and Regulations
Pertaining to Communicable Disease in Arkansas (Ark. Code Ann. §§
20-7-109, 110.); and
b. the Rules Pertaining to the Control of
Communicable Diseases-Tuberculosis.
2. Induced Terminations of Pregnancy. Each
induced termination of pregnancy which occurs in Arkansas shall be reported to
the Division of Health Statistics on a monthly basis.
3. Adverse events associated with
abortion-inducing drugs to:
a. USFDA via
Medwatch reporting system; and
b.
Arkansas State Medical Board.
4. Abortion complications. Each abortion
facility shall report each abortion complication (including live birth)
diagnosed or treated by the facility. Reports shall be submitted to the
Arkansas Department of Health, Division of Vital Statistics
.
a. not later than the 30th day after the date
on which the abortion complication was diagnosed or treated;
c. in the form and manner prescribed by the
Department;
d. not identify by any
means the physician performing the abortion;
e. not identify by any means the patient upon
whom the abortion was performed nor the patient; and
f. containing:
1. the most specific, accurate, and complete
reporting for the highest level of specificity;
2. the date of the abortion that caused or
may have caused the abortion complication;
3. the type of abortion that cause or may
have caused the abortion complication;
4. the gestational age of the fetus at the
time that the abortion was performed;
5. the name and type of healthcare facility
in which the abortion was performed;
6. the date the abortion complication was
diagnosed or treated;
7. the name
and type of any healthcare facility other than the reporting healthcare
facility in which the abortion complication was diagnosed or treated;
8. a description of the abortion
complication;
9. the patient's year
of birth, race, marital status, state of residence, and county of
residence;
10. the date of the
first day of the patient's last menstrual period that occurred before the date
of the abortion that caused or may have caused the abortion complication, if
known;
11. the number of previous
live births of the patient; and
12.
the number of previous induced abortions of the patient.
g. An event associated with a medical
procedure performed after a natural miscarriage, spontaneous abortion, or fetal
death is not subject to reporting under this rule.
O. Each facility shall ensure that
each dead fetus or fetal remains are disposed of in accordance with the
provisions of Ark. Code. Ann. §
20-17-102.1
1. The requirements of this subsection shall
not apply to abortions induced by the administration of medications when the
evacuation of any human remains occurs at a later time and not in the presence
of the inducing physician nor at the facility in which the physician
administered the inducing medications.
P. Seventy-two (72) Hour Reflection Period. A
physician, facility, employee or volunteer of a facility, or any other person
or entity shall not require or obtain payment for a service provided in
relation to abortion to a patient who has inquired about an abortion or
scheduled an abortion until the expiration of the 72-hour reflection period
required by Act 383 of 2017 as amended by Act 801 of 2019, Ark. Code Ann.
§
20-16-1703(d).
1 Section 6(O) was promulgated in
2017. At the time of filing this Rule Section 6(O) is enjoined by Hopkins v.
Jegley, No. 4:17-cv-00404-KGB, 2021 U.S. Dist. LEXIS 1602 (E.D. Ark. Jan. 5,
2021).
SECTION 7.
PATIENT CARE SERVICES.
An Abortion Facility shall have an adequate number of personnel
qualified under this section available to provide direct patient care as
needed.
A. Qualifications.
1. Only physicians who are currently licensed
to practice medicine in Arkansas may perform abortions.
2. All facility personnel, medical and
others, shall be licensed to perform the services they render when such
services require licensure under the laws of the State of Arkansas.
Documentation of current licensure shall be maintained in the personnel file
for each employee.
3. Providers of
patient counseling shall, at a minimum, possess current licensure as a nurse,
Social Worker, or documented experience and training in a related field.
Special training in counseling which is deemed acceptable by the Department
shall be required.
4. All clinical
staff of the facility shall be required to provide documentation of training
and continued competence in cardiopulmonary resuscitation (CPR) or its
equivalent.
B. Staffing
Requirements.
1. There shall be a sufficient
number of Registered Nurses in the facility at all times when patients are
present.
2. Registered Nurses shall
be on duty to supply or supervise all nursing care of patients.
C. Authority and responsibilities
of all patient care staff shall be clearly defined in written policies,
including periodic monitoring and assessment of patients.
D. Services shall be organized to ensure
management functions are effectively conducted. These functions shall include,
but are not limited to:
1. review of policies
and procedures at least annually to reflect current standards of
care;
2. establishment of a
mechanism for review and evaluation of care and services provided at the
facility;
3. orientation and
maintenance of qualified staff for provision of patient care;
4. annual in-service education programs for
professional staff; and
5.
provision of current nursing literature and reference materials.
E. Patients shall have access to
twenty-four (24) hour telephone consultation with either a Registered Nurse or
physician associated with the facility.
F. Follow-up appointments - medical
abortions.
1. Facility personnel shall
schedule a follow-up appointment for the patient to return 12-18 days, or as
recommended in the final printed labeling, after a medical abortion.
2. Facility personnel shall make reasonable
efforts to ensure that the patient returns for the follow-up
appointment.
G. A
Registered Nurse shall plan, supervise, and evaluate the nursing care of each
patient from admission to the facility through discharge.
H. Counseling services.
1. Seventy two (72)- hours prior to the
abortion, the patient shall be counseled regarding the abortion procedure,
alternatives to abortion, informed consent (including consent for unemancipated
minors and women under legal guardianship or custodianship), medical risks
associated with the procedure, potential post-abortion complications, community
resources, family planning, and ADH printed materials and DVD available on the
ADH website at:
www.healthy.arkansas.gov and
patient shall be given a copy of the most current ADH printed materials and
DVD.
2. Documentation of counseling
shall be included in the patient's medical record.
3. The patient shall meet individually and in
a private room with the physician, referring physician, or a qualified
person.
4. Each patient shall be
assessed by a Registered Nurse for counseling needs post-abortion;
5. Written instructions for post-abortion
care shall be given to the patient at discharge, to include at least the
following:
a) signs and symptoms of possible
complications;
b) activities
allowed and to be avoided;
c)
hygienic and other post-discharge procedures to be followed;
d) abortion Facility emergency telephone
numbers available on a twenty-four (24) hour basis; and
e) follow up appointment, if
indicated.
6. The patient
shall be counseled regarding Rh typing and shall be given Rh immune globulin,
if indicated.
I.
Drug-induced, chemical and surgical abortions shall not be performed by
telemedicine.
J. Initial
administration of abortion-inducing drugs shall occur in the same room and
physical presence of the physician who prescribed, dispensed, or otherwise
provided the drug(s) to the patient.
K. Patient shall receive and acknowledge a
copy of the USFDA label(s) for any abortion inducing drugs(s) she
receives.
SECTION 8.
PROGRAM REQUIREMENTS.
A.
Admission Evaluation. Every woman seeking to have an abortion shall be
registered by the facility and evaluated by means of a history, physical
examination, counseling, and laboratory tests.
1. Verification of Pregnancy. Pregnancy
testing shall be available to the patient and may precede actual registration
by the facility. No abortion shall be performed unless the examining physician
verifies the patient is pregnant. Pregnancy test results shall be filed in the
patient's medical record.
2.
History and Physical Examination. Prior to the abortion, a medical history
shall be obtained and recorded. The patient shall be given an appropriate
physical examination, as determined by the physician, and may include testing
for sexually transmitted diseases.
a. Physical
examinations preceding medical abortions shall include a determination of
gestational age and location of pregnancy.
b. Pelvic examinations shall be performed
only by qualified personnel, as defined by their Practice Acts.
3. Pre-abortion Tests. The
following are required prior to an abortion: hematocrit or hemoglobin, Rh
typing, and abdominal ultrasound for fetal heartbeat detection. Other onsite
proof of pregnancy, such as pregnancy test, copy of a pregnancy test or
ultrasound may also be performed according to facility policy.
4. Counseling. Patient counseling services
shall be offered prior to initiation of any abortion and if indicated following
the abortion. In addition to verbal counseling, patients shall be given and
allowed to keep the most current ADH printed materials and DVD.
B. Anesthetic agents.
1. Anesthesia, analgesia and anoxiolysis
shall be administered only by a qualified professional acting within the scope
of his or her Arkansas license.
2.
Anesthesia administration in Abortion Facilities shall be limited to local
anesthesia, minimal sedation, and moderate sedation.
C. Discharge criteria, developed by the
clinical staff and approved by the Governing Body, may be utilized to evaluate
patients' medical stability for discharge. Patients may be discharged only on
the order of a physician. Patients receiving sedation shall be discharged in
the company of a responsible adult.
D. Complications.
1. General Abortion Facilities shall have
emergency drugs, oxygen, intravenous fluids, and other emergency equipment on
site and readily available to stabilize a patient if necessary.
2. All clinical staff shall have documented
current competency in cardiopulmonary resuscitation (CPR).
E. Human/Fetal Tissue Disposal.
1. A physician or facility that performs an
abortion shall ensure that fetal remains and all parts are disposed of in a
fashion similar to that in which other tissue is disposed
NOTE: Act 535 of 2015, Ark. Code
Ann.
§
20-17-802 provides:
***
(b)
A
person shall not perform any biomedical or behavioral research on:
(1)
a fetus born alive as the result
of a legal abortion unless the research is for the exclusive benefit of the
fetus so born; or
(2)
a fetus born dead as the result of a legal abortion or any fetal tissue
produced by the abortion.
(c)
a person shall not buy, sell,
give, exchange, or barter or offer to buy, sell, give, exchange, or barter any
fetus born dead as a result of a legal abortion or any organ, member, or tissue
of fetal material resulting from a legal abortion.
(d)
a person shall not possess either
a fetus born dead as a result of a legal abortion or any organ, member, or
tissue of fetal material resulting from a legal abortion.
(e)
This section does not apply
to:(1)
a physician
performing a legal abortion or a pathologist performing a pathological
examination as the result of a legal abortion;
(2)
an employee, agent, or servant of
a physician performing a legal abortion or pathologist performing a
pathological exam as the result of a legal abortion;
(3)
the staff, faculty, students, or
governing body of any institution of higher learning or institution of
secondary education to the extent of courses of instruction taught and research
conducted at the institutions;
(4)
licensed physicians or their
employees, agents, and servants while in the conduct of medical
research;
(5)
any
licensed physician when performing a standard autopsy examination;
or
2.
An external member of the human body shall not be disposed of within
forty-eight (48) hours of its removal or acquisition unless consent is obtained
in writing from the patient or the person authorizing the medical or surgical
treatment of the patient.
3. All
human tissue shall be disposed of in a respectful and proper manner in
compliance with the Arkansas Department of Health Rules Pertaining to The
Management of Medical Waste from Generators and Health Care Related
Facilities.
SECTION
9.
HEALTH INFORMATION SERVICES.
The Abortion Facility shall maintain a system for the
completion and storage of the medical record. The record shall provide a format
for continuity and documentation of legible, uniform, complete, and accurate
patient information readily accessible and maintained in a system that ensures
confidentiality.
A. General
Requirements.
1. The Abortion Facility shall
adopt a record form for use that contains information required for transfer to
an acute care facility.
2. Record
reviews with criteria for identification of problems and follow up shall be
reported to the Medical Director at least quarterly.
3. Responsibility for the processing of
records is assigned to an individual employed by the Abortion
Facility.
4. All medical records
shall be retained in either the original, microfilm, or other acceptable
methods for ten (10) years after the last discharge.
5. The original or a copy of the original
(when the original is not available) of all reports shall be filed in the
medical record.
6. The record shall
be permanent and shall be either typewritten or legibly written in blue or
black ink.
7. All typewritten
reports shall include the date of dictation and the date of
transcription.
8. All dictated
records shall be transcribed within forty-eight (48) hours.
9. Errors shall be corrected by drawing a
single line through the incorrect data, labeling it as "error", initialing, and
dating the entry.
10. Policies and
procedures for Health Information Services shall be developed. The manual shall
have evidence of ongoing review and/or revision. The first page of the
manual(s) shall have the annual review date and signatures of the person(s)
conducting the review.
11. Medical
records shall be protected to ensure confidentiality, prevent loss, and ensure
reasonable availability.
12. All
medical records, whether stored within the facility or away from the facility
shall be protected from destruction by fire, water, vermin, dust,
etc.
13. Medical records shall be
considered confidential. All medical records (including those filed outside the
facility) shall be secured at all times. Records shall be available to
authorized personnel from the Arkansas Department of Health.
14. Written consent of the patient and/or
parent, legal guardian or custodian shall be presented as authority for release
of medical information. There shall be policies and procedures developed
concerning all phases of release of information.
15. Original medical records shall not be
removed from the facility except upon receipt of a subpoena ducestecum by a
court having authority for issuing such an order.
16. Medical records shall be complete and
contain all required signed documentation no later than thirty (30) days
following the patient's discharge.
17. After the required retention period,
medical records may be destroyed by burning or shredding. Medical records shall
not be disposed of in landfills or other refuse collection sites.
18. Each entry into the medical record shall
be authenticated by the individual who is the source of the information.
Entries shall include all observations, notes, and any other information
included in the record.
19.
Signatures shall be, at least, the first initial, last name, and title.
Computerized signatures may be either by code, number, initials, or the method
developed by the facility.
20.
There shall be policies and procedures for use of electronic medical records.
The policies and procedures shall provide for the use, exchange, security, and
privacy of electronic health information. The policies and procedures shall
provide for standardized and authorized availability of electronic health
information for patient care and administrative purposes. The policies and
procedures will be in compliance with current guidelines and standards as
established in federal and state statutes.
B. Record Content. Each record shall include
but not be limited to documentation of:
1.
demographic and patient information;
2. informed consent:
a. Informed Consent Checklist form
AS-4010;
b. Documented evidence
statistical probability of bringing unborn human individual to term based on
gestational age of the unborn individual possessing a detectable heartbeat was
reviewed and signed by the pregnant woman;
c. Fetal Pain Checklist in cases where
woman's pregnancy has progressed to twenty (20) weeks gestation or more (form
AS-4010A);
d. For unemancipated
minors and women under legal guardianship or custodianship for incompetence,
Abortion Disclosure and Consent Form for Minors and Women under Legal
Guardianship or Custodianship for Incompetency form AS-4011; and
e. In cases of medical emergency where
informed consent is not obtained, physician's written certification of:
1) nature of the emergency;
2) waiver of consent; and
3) circumstances that necessitated the
waiver;
3.
complete family, medical, social, reproductive, nutrition, and behavioral
history;
a. initial physical
examination;
b. evaluation of risk
status;
c. laboratory test
results;
d. gestational
age;
e. ultrasound image;
1) opportunity for patient to view
ultrasound;
2) patient acceptance
or rejection of viewing ultrasound;
f. testing for fetal heartbeat and if
heartbeat detected, an acknowledgment form as required by Ark. Code Ann. §
20-16-1303(e);
and
g. for medical abortions,
intrauterine location of pregnancy.
4. appropriate referral of patients, as
indicated;
5. documentation of each
periodic examination, including any follow-up appointment;
6. patient counseling regarding the abortion,
alternatives to abortion, informed consent (including consent for unemancipated
minors and women under legal guardianship or custodianship), medical risks
associated with the abortion, potential post-abortion complications, available
community resources, and family planning, and most current ADH printed
materials and DVD;
7. patient
education regarding post-abortion signs and symptoms of possible complications,
activities allowed and to be avoided, hygienic and other postdischarge
procedures to be followed, telephone numbers to access emergency care, and
follow-up appointments;
8. abortion
and post-abortion records;
a. for surgical
abortions, a written report describing surgical instruments used, surgical
techniques, findings and tissues removed or altered;
b. for medical abortions, documentation of
date, time, name of individual(s), and description of efforts made regarding
patient follow-up appointment;
9. copies of proof of parent or guardian
identification and relationship in cases where pregnant woman is an
unemancipated minor or an incompetent woman under legal guardianship or
custodianship, including:
a. photocopy of
government-issued photo identification card; and
b. photocopy of written documentation that
establishes that the parent or legal guardian is the lawful parent or legal
guardian of the pregnant woman;
c.
documentation required by (9)(B)(11)(a) shall be maintained for five (5) years
past the patient's age of majority and no less than seven (7) years;
and
10. physician
affidavit when abortion is performed after receiving parental or legal guardian
or custodian consent ("Abortion Disclosure and Consent form for Unemancipated
Minors and Women under Legal Guardianship or Custodianship for Incompetency"
ADH form AS4011).
SECTION
10.
INFECTION CONTROL FOR ABORTION FACILITIES.
A. General.
1. The facility shall develop and use a
coordinated process that effectively reduces the risk of endemic and epidemic
healthcare associated infections in patients and health care workers.
2. The facility shall follow nationally
recognized guidelines and manufacturer's instructions.
3. There shall be a designated infection
prevention and control officer for the facility.
4. There shall be policies and procedures
establishing and defining the Infection Prevention and Control Program
including:
a. Definitions of healthcare
associated infections which conform to the current CDC definitions;
b. Methods for obtaining reports of
infections in abortion patients and health care workers in a manner and time
sufficient to limit the spread of infections;
c. Measures for assessing and identifying
abortion patients and health care workers at risk for healthcare associated
infections and communicable diseases;
d. Measures for prevention and control of
infections;
e. Provisions for
education of patients and family concerning infections and communicable
diseases including hand hygiene and isolation precautions;
f. Plans for monitoring and evaluating all
infection prevention and control policies and procedures;
g. Techniques for hand hygiene including
procedures for soap and water as well as alcohol based hand rub if
used;
h. Scrub technique (applies
only to General Abortion Facilities);
i. Asepsis/sterile technique;
j. Sterilization to include;
1) Evaluating effectiveness of
sterilization;
2) Receiving,
decontaminating, cleaning, preparing, disinfecting and sterilizing reusable
items;
3) Specifications for
cold-liquid sterilization, steam sterilization, and gas sterilization (if
used);
4) Sterilization techniques
(steam, plasma, ethylene oxide, chemical, etc.) shall follow the manufacturer's
directions and meet all state and federal regulations;
5) Assembling and wrapping of packs (to
include the double-wrapped techniques);
6) Autoclaves to include:
i. Records shall be maintained of all
autoclave loads, both routine and immediate use which shall include the date,
time, lot number (on routine loads), the time at temperature (where a recorder
is not available), item(s) sterilized and shall identify the person performing
the task;
ii. The efficacy of
autoclaves, both for routine and immediate use shall be determined weekly
through the use of biological spore monitors;
iii. The results of all biological spore
monitoring shall be reported to the infection prevention and control
officer;
iv. Failures of the
biological spore test shall be brought to the attention of the infection
prevention and control officer or designee immediately so the appropriate
surveillance measures can be initiated;
v. All materials sterilized from the date of
the biological spore monitor failure to the last successful biological spore
monitor shall be re-sterilized before use;
vi. Autoclaves within the facility shall be
maintained in accordance with manufacturer's written directions. Records shall
be maintained of all maintenance and repairs for the life of the
equipment;
vii. Chemical indicators
for sterility shall be used with each cycle;
viii. Compliance and efficacy of the
sterilization policies shall describe the mechanism used to determine the shelf
life of sterilized packages;
ix.
Products used to contain or wrap instrument sets/pans for sterilization shall
follow the manufacturers' directions or nationally recognized standards (such
as CDC or AORN) in determining the shelf life of the sterilized
items(s);
x. All items which are to
be sterilized, whether for immediate use or to be stored, shall be cleaned and
decontaminated before the sterilization process;
xi. Immediate use (autoclaving) shall be
restricted to unplanned or emergency situations and never used as a convenience
to compensate for inadequate inventories of instruments; and xii. Procedures
for unloading and transporting immediate use sterilized items, which provide
for the aseptic transfer within the physical constraints of the
facility.
k.
Disinfection to include;
1) Cleaning of
equipment;
2) Evaluating
effectiveness of cleaning;
3)
Cleaning and disinfecting of surfaces, utensils, and equipment;
4) Receiving, decontaminating, cleaning,
preparing, disinfecting and sterilizing reusable items; and
5) A requirement that disinfectants,
antiseptics, and germicides be used in accordance with the manufacturer's
directions;
l.
Housekeeping;
m. Linen
care;
n. Liquid and solid waste
disposal of both infectious and regular waste. Disposal of infectious waste
shall conform to the latest edition of the Rules Pertaining to the Management
of Medical Waste from Generators and Health Care Related Facilities;
o. Disposal of human and fetal
tissue;
p. Sharps safety;
q. Separation of clean from dirty processes;
and r. Other means of limiting the spread of contagion;
s. Supplies and storage to include:
1) Storage and distribution of sterile
equipment/medical supplies;
2)
Recalling and disposing/reprocessing of outdated sterile supplies;
3) Collection and disposal of supplies
recalled by the manufacturer;
4)
Precautions to prevent the mixing of sterile and unsterile supplies and
equipment;
5) Items previously
packaged, sterilized and issued but not used may be returned to the sterile
storage area if the integrity of the packaging has not been compromised and
there is no evidence of contamination; and
6) Sterile materials shall be stored eight to
ten inches from the floor and at least 18 inches from the ceiling and at least
two inches from outside walls. Items shall be positioned so that packages are
not crushed, bent, compressed or punctured and sterility is not
compromised.
B. Employee Health.
1. There shall be an orientation program for
all new health care workers concerning the importance of infection control and
each health care worker's responsibility in the facility's Infection Prevention
and Control Program.
2. There shall
be a plan for each employee to receive annual in-services and educational
programs, as indicated, based upon assessment of the infection control
process.
3. The facility shall
develop policies and procedures for screening health care workers for
communicable diseases and monitoring health care workers exposed to patients
with any communicable diseases.
4.
There shall be policies regarding health care workers with infectious diseases
or carrier states. The policies shall clearly state when health care workers
shall not render direct patient care.
NOTE: Health care workers employed by the facility who are
afflicted with any disease in a communicable stage, or while afflicted with
boils, jaundice, infected wounds, diarrhea, or acute respiratory infections,
shall not work in any area in any capacity in which there is a likelihood of
such person contaminating food, food contact surfaces, supplies, or any surface
with pathogenic organisms or transmitting disease to patients, facility
personnel or other individuals within the facility.
5. There shall be Measures for prevention of
communicable disease outbreaks, especially mycobacterium tuberculosis (TB). All
plans for the prevention of transmission of TB shall conform to the most
current CDC Guidelines for Preventing the Transmission of Mycobacterium
Tuberculosis in Health Care Facilities.
6. There shall be a plan for ensuring that
all health care workers who are frequently exposed to blood and other
potentially infectious body fluids are offered immunizations for hepatitis
B.
SECTION 11.
PHARMACEUTICAL SERVICES.
A.
Organization.
1. Abortion Facilities shall
have provisions for pharmaceutical services regarding the procurement, storage,
distribution and control of all medications. The Abortion Facility shall be in
compliance with all state and federal regulations.
2. Pharmaceutical services shall be under the
direction of a licensed pharmacist if required by State law. In case the
Abortion Facility does not require a licensed pharmacist, the Medical Director
shall assume the responsibility of directing Pharmaceutical Services. A
licensed pharmacist means any person licensed to practice pharmacy by the
Arkansas State Board of Pharmacy who provides pharmaceutical services as
defined in the Pharmacy Practice Act. The pharmacist or Medical Director shall
make provisions that shall include, but not be limited to:
a. development and implementation of pharmacy
policies and procedures;
b. annual
review and revisions of pharmacy policies and procedures, with documentation of
dates of review;
c. maintenance of
medications in the Abortion Facility to meet the needs of the population
served;
d. maintenance of
medications in the Abortion Facility to ensure accountability; and
e. proper storage of medications.
B. Staffing.
Pharmaceutical services shall be provided by a licensed pharmacist or Medical
Director as required by State law. If the service is provided by a consulting
pharmacist, it may be done so on a consulting basis. Onsite consultation by the
pharmacist shall be required at least monthly. Documentation of each
consultation visit shall be recorded and maintained at the Abortion Facility.
Documentation of each visit shall include compliance with, but not be limited
to:
1. proper storage of drugs;
2. disposal of medications no longer needed,
discontinued, or outdated;
3. proof
of receipt and administration of controlled substances and proper storage of
such medications;
4. verification
that medications in stock conform to the specified quantities on posted
lists;
5. proper labeling;
and
6. maintenance of emergency
carts or kits.
7. If the service is
under the direction of the Medical Director, he/she may designate the above
required monthly documentation to a licensed nurse.
C. Policies and Procedures. There shall be
pharmacy policies and procedures to include, but not be limited to:
1. detailed job description of the licensed
pharmacist and/or Medical Director;
2. procurement of medications;
3. distribution and storage of
medications;
4. a listing of stock
medications with minimum and maximum quantities to be maintained in the
Abortion Facility;
5. a listing of
medications with exact quantities to be maintained in emergency kits;
6. destruction of deteriorated, non-sterile,
unlabeled, or damaged medications;
7. listing controlled substances to be
destroyed on the proper forms and either sending a copy of the form with the
medications to the Arkansas Department of Health by registered mail or
delivering the form and medications in person;
8. maintenance of all drug records for a
minimum of two (2) years;
9.
maintenance of medications brought to the Abortion Facility;
10. drug recalls;
11. reporting of adverse drug reactions and
medication errors to the attending physician and the Governing Body;
12. accountability of controlled
substances;
13. reporting of
suspected drug loss, misuse, or diversion, according to state law;
14. use of Automatic Medication Dispensing
Devices, if applicable.
D. Drug storage and security. Medications
maintained at the Abortion Facility shall be properly stored and safeguarded to
ensure:
1. locked storage of all
medications;
2. proper lighting and
ventilation, as required by the manufacturer;
3. proper temperature controls with daily
temperature documentation of medication refrigerators to ensure storage between
thirty-six (36) and forty-six (46) degrees Fahrenheit, or two (2) to eight (8)
degrees Centigrade;
4. separate
storage of biologicals and medications from food;
5. accessibility to licensed personnel only;
and
6. proper use of any Automatic
Medication Dispensing Devices.
E. Controlled Substances.
1. Controlled drugs shall be double
locked.
2. A record of the
procurement and disposition of each controlled substance shall be maintained in
the Abortion Facility and be readily retrievable. Each entry on the disposition
record shall reflect the actual dosage administered to the patient, the
patient's name, date, time, and signature of the licensed person administering
the medication. The signature shall consist of a first initial, last name, and
title. (Licensed personnel who may legally administer controlled substances
shall include only those personnel authorized by their current Practice Act and
licensed by the Arkansas State Medical Board or Arkansas State Board of
Nursing.) Any error of entry on the disposition record shall follow a policy
for correction of errors and accurate accountability. If the licensed person
who procures medication from the double locked security is not the licensed
person who administers the medication, then both persons shall sign the
disposition record;
3. When
breakage or wastage of a controlled substance occurs, the amount given and
amount wasted shall be recorded by the licensed person who wasted the
medication and verified by the signature of a licensed person who witnessed the
wastage. Documentation shall include how the medication was wasted. In addition
to the above referenced licensed personnel, licensed pharmacists shall be
allowed to witness wastage of controlled substances. When a licensed person is
not available to witness wastage, the partial dose shall be sent to the
Arkansas Department of Health, Division of Pharmacy Services and Drug Control
for destruction;
4. There shall be
an audit each shift change of all controlled substances stocked in the Abortion
Facility which shall be recorded by an oncoming nurse and witnessed by an
off-going nurse. If only one (1) shift exists, an audit shall be conducted at
the opening and closing of the abortion facility daily. If discrepancies are
noted, the Director of Nursing, Pharmacy Consultant and/or Medical Director
shall be notified. As with the witnessing of wastage, licensed pharmacists
shall be allowed to witness controlled
5. substance audits;
6. Records generated by Automatic Dispensing
Devices shall comply with these requirements.
F. Medications.
1. All verbal or telephone orders for
medications shall be received by a licensed nurse or Registered Pharmacist and
reduced to writing into the patient's medical record. Verbal or telephone
orders shall be countersigned by the practitioner within twenty-four (24)
hours. Signed facsimile orders are acceptable, provided the facsimile paper is
of a permanent nature.
2. The
Abortion Facility may procure medications for its patients through community
pharmacists, or medications may be procured through the facility's
physician.
SECTION
12.
PHYSICAL FACILITIES, ABORTION FACILITIES.
A. Definitions.
1.
Accessible - barrier free;
approachable by all peoples including those with physical
disabilities.
2.
Addition - an extension or increase in floor area and/or height of
an existing building, or structure.
3.
Alter or Alteration - any
change(s) and modification in construction, occupancy, installation, or
assembly of any new structural components, and any change(s) to the existing
structural component, in a system, building, and structure.
4.
And/Or (in a choice of two
(2) code provisions) - signifies use of both provisions shall satisfy the code
requirements and use of either provision is acceptable, also. The most
restrictive provision shall govern. Where there is a conflict between a general
requirement and a specific requirement, the specific or restrictive requirement
shall be applicable.
5.
Architect - a duly registered professional licensed by the
Arkansas State Board of Architects to use the title "architect."
6.
Corridor - a passage way into
which compartments or rooms open and which is enclosed by partitions and/or
walls and a ceiling, or a floor/roof deck above.
7.
Engineer - duly registered
professional licensed by the Arkansas Board of Registration for Professional
Engineers and Land Surveyors to use the title "engineer."
8.
New construction - the
assembly of a new free standing structure.
9.
Renovation - construction
performed within an existing facility.
10.
Room - a separate, enclosed
space, with doorway(s), for the one (1) named function.
11.
Toilet - a room designed
exclusively for a water closet and lavatory.
B. Plan Review. Plans for all new
construction and/or alterations shall include site requirements, preliminary
drawings, submission of plan review fee, final construction documents, letter
of approval for construction documents, site observation and final site
observation.
1. No new mechanical, electrical,
plumbing, fire protection, or medical gas system shall be installed, nor any
such existing system materially altered or extended, until complete drawings
and specifications for installation, alteration, or extensions have been
submitted to the Division for review and approval.
2. Site Requirements.
a. The site location shall be easily
accessible to the community and to service vehicles such as fire protection
apparatus.
b. The Abortion Facility
shall have security measures for patients, personnel, and the public consistent
with the conditions and risks inherent in the location of the
facility.
c. Site utilities shall
be reliable (water, natural gas, sewer, electricity and communication). The
water supply shall have the capacity to provide normal usage plus fire-fighting
requirements. The electricity shall be of stable voltage and
frequency.
d. The site shall afford
good drainage and shall not be subject to flooding.
e. Soil bearing capacity shall be sufficient
to support the building and paved areas.
f. Paved access roads and walks shall be
provided within the boundary of the property to public service and emergency
entrances.
g. Paved parking spaces
shall be provided to satisfy the needs of patients, employees, staff, and
visitors. In the absence of a formal parking study, each facility shall provide
not less than one (1) space for each day shift staff member and employee plus
one (1) space for each patient bed/recliner. Parking spaces shall be provided
for emergency and delivery vehicles.
3. Preliminary Drawings. Schematic drawings
for the Abortion Facility shall be submitted to the Division. These drawings
shall illustrate a basic understanding of the architectural, mechanical,
electrical and plumbing systems. Schematic drawings shall include schematic
plans, building sections, exterior elevations (all sides), preliminary finish
schedule, and general notes. Code criteria shall be submitted that is specific
to the proposed facility and exhibits knowledge of the building and fire code
requirements including but not limited to construction type, fire protection
ratings, means of egress and smoke compartmentalization. Drawings shall be at a
scale to clearly represent the intent. A graphic and/or written scale and
directional arrow shall be on each drawing.
4. Submission of Plan Review Fee. A plan
review fee in the amount of one (1) percent of the total cost of construction
or five hundred dollars ($500.00), whichever is less, shall be paid for the
review of drawings and specifications. The plan review fee check is to be made
payable to the Division of Accounting, Arkansas Department of Health. A
detailed estimate must accompany the plans unless the maximum fee of
five-hundred dollars ($500.00) is paid. The Division will coordinate review of
plans for all Arkansas Department of Health offices.
5. Final Construction Documents.
a. Plans and specifications shall be prepared
by an architect and/or engineer licensed by the State of Arkansas. The
architect and engineer shall prepare and submit construction documents with the
respective seals for each professional discipline. Architectural construction
documents shall be prepared by an architect, and engineering (mechanical,
electrical, civil and structural) construction documents shall be prepared by
an (mechanical, electrical, civil and structural) engineer. Periodic
observations of construction shall be provided and documented by each design
professional to assure that the plans and specifications are followed by the
contractor, and that "as build" prints are kept current. The interval for
periodic observation shall be determined and approved by the Division prior to
beginning construction.
b. Working
drawings and specifications shall be prepared in a manner that clearly defines
the scope of the work and is consistent with the professional standard of
practice for architects and engineers. Working drawings and specifications
shall be complete for contract purposes.
c. Final construction documents shall be
reviewed and approved by the Division prior to the beginning of construction.
The Division shall have a minimum of six (6) weeks to review final construction
documents after which time an approval letter shall be issued. Plan review with
other Health Department Divisions shall be coordinated by the
Division.
6. Site
Observation During Construction. The Abortion Facility shall be observed during
construction and before occupancy.
a. The
Division shall be notified when construction begins and a construction schedule
shall be submitted to determine inspection dates.
b. Representatives from the Division shall
have access to the construction premises and the construction project for
purposes of making whatever inspections deemed necessary throughout the course
of construction.
c. Any deviation
from the approved construction documents shall not be permitted until a written
construction addenda or change order is approved by the Division.
7. Final Site Observation.
a. Upon completion of construction and prior
to occupancy approval by the Division, the owner shall be furnished one (1)
complete set of contract documents, plans and specifications showing all
construction, fixed equipment, and mechanical and electrical systems as
installed or built. In addition, the owner shall be furnished a complete set of
installation, operation, and maintenance manuals and parts lists for the
installed equipment.
b. No Abortion
Facility shall occupy any new construction, addition, renovation and/or
alteration until approval has been granted from all city, county, and other
state regulatory agencies in addition to the Division.
C. General Considerations.
1. The requirements set forth herein have
been established as minimum requirements for new construction, addition(s),
renovation(s) and alteration(s) in Abortion Facilities requiring licensure
under these regulations.
2.
Abortion Facilities undertaking new construction, an addition, renovation,
and/or alteration shall minimize disruption of existing functions. Access,
exits and fire protection shall be maintained for occupancy safety.
3. The building and equipment shall be
maintained in a state of good repair at all times.
4. The premises shall be kept clean, neat,
free of litter and rubbish.
D. Codes and Standards.
1. Nothing stated herein shall relieve the
owner from compliance with building, fire, subdivision and zoning codes,
ordinances, and regulations of city, county and other state agencies.
2. Compliance with referenced codes and
standards shall be that of the latest edition(s).
3. Accessibility requirements shall be those
set forth by the Arkansas State Building Services, Minimum Standards and
Criteria - Accessibility for the Physically Disabled Standards.
4. Electrical Systems. Electrical devices
shall be installed in accordance with NFPA 70, National Electrical
Code.
5. Mechanical Systems.
a. HVAC systems shall be installed in
accordance with the Arkansas State Mechanical Code.
b. Air ventilation and filtering requirements
shall be in accordance with ASHRAE Standard 62, Ventilation for Acceptable
Indoor Air Quality and ASHRAE 52, Filter Efficiencies.
6. Plumbing and Gas Systems.
a. Plumbing systems shall be installed in
accordance with the Arkansas State Plumbing Code.
b. Gas systems shall be installed in
accordance with the Arkansas State Gas Code.
7. New Abortion Facilities shall meet the
criteria of NFPA 101, Life Safety Code, Chapter 26, New Business Occupancies.
Existing buildings proposed for use as Abortion Facilities shall meet the
criteria of NFPA 101, Life Safety Code, Chapter 27, Existing Business
Occupancies. Both new Abortion Facilities and existing buildings proposed for
use as Abortion Facilities shall meet the following additional requirements:
a. Emergency lighting shall be connected to
rechargeable back-up (ninety (90) minute minimum duration) batteries as a means
of emergency illumination for procedure rooms, corridors, stairways, exit signs
and at the exterior of each exit.
b. A protected premises fire alarm system as
defined in NFPA 72, National Fire Alarm Code, Chapter 3 shall be
required.
c. Fire extinguisher(s)
shall be easily accessible and shall be provided, located, and inspected as
defined in NFPA 10, Standard for Portable Fire Extinguishers.
d. At least two (2) separate exits that are
remote from each other shall be provided on every story of Abortion Facility
use.
e. The minimum clear door
opening for patient use shall be two (2) feet eight (8) inches.
f. Gas fired equipment rooms shall be
separated with one (1) hour fire resistance partitions.
g. No operable fireplace shall be permitted.
Inoperable fireplace(s) shall be sealed at the upper and lower portions of the
flue.
h. Cabinets or casework in
patient use areas shall be furred to the ceiling above or provided with sloping
tops to facilitate cleaning.
i. A
panic bar releasing device shall be provided for all required exit doors
subject to patient traffic.
j.
Medical gas, air and vacuum systems, if provided, shall meet installation,
testing, maintenance and certification criteria of NFPA 99, Standard for Health
Care Facilities.
E. Design Considerations
1. Each Abortion Facility design shall ensure
patient acoustic and visual privacy during interview, examination, treatment
and recovery.
2. The premises shall
be kept free from insect and vermin infestation.
3. The building shall be well ventilated at
all times with a comfortable temperature maintained.
4. Space and facilities shall be provided for
the sanitary storage and disposal of waste by incineration, containment or
removal, or by a combination of these techniques.
5. Waiting/Reception area(s) shall be
provided with sufficient seating for the maximum number of people that may be
waiting at any one (1) time. A reception and information counter or desk shall
be provided.
6. A barrier free
public toilet rooms shall be provided. This room may be conveniently located
outside the Abortion Facility as part of shared tenant spaces in the same
building.
7. Public telephone(s)
shall be provided.
8. A
housekeeping room with mop sink shall be provided.
9. Storage space shall be provided for both
administrative and clinical needs.
10. A business office room shall be
provided.
11. A medical records
storage room shall be provided. This room shall protect records against undue
destruction from dust, vermin, water, smoke and fire. It shall be constructed
as a one (1) hour fire resistance rated enclosure and protected by a smoke
detection system connected to the fire alarm. Storage for records shall be
accessible and at least six (6) inches above the floor.
12. A consultation room shall be
provided.
13. An examination room
shall be provided. The examination room shall have a minimum floor area of
eighty (80) square feet excluding fixed millwork, vestibule, toilet and
closets. The room shall contain an examination table and chair, charting
counter or desk, instrument table and shelves, hand-washing sink and equipment
storage as needed. Room arrangement shall permit at least three (3) feet
clearance at each side and at the foot of the examination table. Entry door
swing and view angles shall maximize patient privacy. This room may be combined
with the procedure room.
F. Interior Finishes.
1. Interior finishes shall meet the flame
spread and smoke development requirements of NFPA 101, Life Safety
code.
2. Finished floors, ceilings
and walls shall be provided for all rooms and spaces except mechanical and
electrical rooms.
3. Procedure
rooms and soiled work rooms shall have a monolithic finish floor and base,
stain resistant for its intended use and integral with each other (i.e., sheet
vinyl floor with continuous sheet vinyl base). Seams in the monolithic floor
and base shall be chemically welded.
4. Toilet rooms, clean work rooms,
housekeeping rooms and examination rooms (when combined with the procedure
room) shall not have a carpeted floor finish.
5. Procedure rooms, soiled work rooms and
clean work rooms shall have smooth, washable, moisture resistant, ceilings of
gypsum board, plaster or mylar faced lay-in ceiling tiles.
6. Wall finishes for all rooms shall be
smooth, moisture resistant and washable.
G. Storage of fetal remains. Each facility
shall have refrigerated storage for holding fetal bodies for 48 (forty-eight)
hours.
H. General Abortion
Facilities: additional requirements. In addition to the preceding requirements,
General Abortion Facilities shall also meet the requirements below.
1. A procedure room shall be provided. The
procedure room shall have a minimum floor area of one-hundred-twenty (120)
square feet excluding fixed millwork, vestibule, toilet and closets. The
minimum room dimension shall be ten (10) feet. The room shall contain a
hand-wash sink with hands-free controls, soap dispenser and single service
towel dispenser.
2. One (1) or more
recovery rooms shall be provided. A recovery room shall have a minimum of sixty
(60) square feet per patient excluding fixed millwork, vestibule, toilet and
closets. The room shall contain a bed or a washable, reclining chair.
Multi-patient recovery rooms shall be provided with cubicle curtains for
patient privacy.
3. A clean work
room shall be provided sufficient in size to process clean and sterilize supply
materials and equipment. This room shall contain a hand-wash sink, work counter
and autoclave adequate in size to sterilize the equipment in use.
4. A soiled work room shall be provided. This
room shall contain a hand-wash sink and work counter.
5. At least one (1) barrier free, patient
toilet room shall be provided for each recovery room.
I. Signage: Text of Signs.
1. A sign shall be conspicuously posted in
each waiting room, patient consultation room, and procedure room used by
patients for whom abortions are performed, induced, prescribed or for whom the
means for an abortion are provided.
2. The signs shall display the following
text:
"It is against the law for anyone, regardless of his or her
relationship to you, to force you to have an abortion. You have the right to
contact any local or state law enforcement or any social service agency to
receive protection from any actual or threatened physical, emotional, or
psychological abuse. It is against the law to perform, induce, prescribe for,
or provide you with the means for an abortion without your voluntary
consent."