Kentucky Administrative Regulations
Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH
Chapter 20 - Health Services and Facilities
Section 902 KAR 20:150 - Alternative birth centers
Universal Citation: 902 KY Admin Regs Service 20:150
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS 216B.010-216B.130, 216B.990(1), (2)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 216B.042 and 216B.105 mandate that the Kentucky Cabinet for Human Resources regulate health facilities and health services. This administrative regulation provides for the licensure requirements for the operation and services and facility specifications of alternative birth centers.
Section 1. Definitions.
(1) "Center"
means alternative birth center.
(2)
"Low risk" means a normal uncomplicated prenatal course as determined by
adequate prenatal care and prospects for a normal uncomplicated birth including
criteria recognized by the American College of Obstetrics and Gynecologists in
their Standards for Obstetric-Gynecologic Services, as amended.
Section 2. Scope of Operations and Services. Alternative birth centers are establishments with permanent facilities which provide prenatal care to low risk childbearing women. An alternative birth center provides a homelike environment for pregnancy and childbirth including prenatal, labor, delivery, and postpartum care related to medically uncomplicated pregnancies.
Section 3. Administration and Operation.
(1) Licensee.
(a) The licensee shall be responsible for the
management and operation of the center and for compliance with federal, state
and local laws and regulations pertaining to its operation.
(b) The licensee shall appoint an
administrator whose qualifications, responsibilities, authority and
accountability shall be defined in writing.
(2) Administrator.
(a) The administrator shall be responsible
for the daily management and operation of the center.
(b) In the absence of the administrator,
responsibility shall be delegated to a similarly qualified staff
person.
(3)
Administrative records and reports.
(a)
Administrative reports shall be established, maintained and utilized as
necessary to guide the operation, measure productivity and reflect the program
of the center. Such reports shall include financial records and reports,
personnel records, inspection reports and other pertinent reports made in the
regular course of business.
(b)
Licensure inspection reports and plans of correction shall be made available at
the center to the public upon request.
(4) Policies.
(a) Administrative policies. The licensee
shall adopt written administrative policies covering all aspects of the
center's operation, to include:
1. A
description of the organizational structure, staffing and allocation of
responsibility and accountability;
2. A description of referral linkages with
physician(s), inpatient facilities and other providers;
3. Policies and procedures for the guidance
and control of personnel performances;
4. A description of services included in the
center's program;
5. A description
of the administrative and patient care records and reports;
6. A policy approved by the medical director
to specify emergency medical procedures;
7. A policy approved by the medical director
which fully identifies the criteria which would exclude a pregnant woman or
mother from the center's program;
8. A policy approved by the medical director
which fully identifies the criteria which would preclude management of newborns
at the center.
(b)
Patients' rights policies. The licensee shall adopt written policies regarding
the rights and responsibilities of patients. These patients' rights policies
shall assure that each patient:
1. Is informed
of these rights and of all rules and regulations governing patient conduct and
responsibilities including a procedure for handling patient
grievances;
2. Is fully informed of
the services and treatment offered at the center and of related charges,
separately identifying those charges not covered by third party payor
arrangements;
3. Is encouraged and
assisted to understand and exercise her patient rights and to this end may
voice grievances and recommend changes in policies and services. Upon the
patient's request the grievances and recommendations will be conveyed within a
reasonable time to an appropriate decision making level within the organization
which has the authority to take corrective action;
4. Is assured confidential treatment of her
records and afforded the opportunity to approve or refuse their release to any
individual not involved in her care except as required by law or third party
payment contract;
5. Is treated
with consideration, respect and full recognization of her dignity and
individuality including privacy in treatment.
(5) Personnel.
(a) The licensee shall establish personnel
policies for the center. These policies shall be reviewed, revised and approved
on an annual basis.
(b) There shall
be an individual personnel record for each person employed by the center which
shall include the following:
1. Preemployment
and annual physical examination to include a tuberculin skin test or chest
x-ray and rubella antibody titer. No employee with direct patient contact
having an infectious disease shall appear at work until the infectious disease
can no longer be transmitted;
2.
Evidence of education, training and experience of the individual along with a
copy of the current license or certification credentials if applicable;
and
3. Evidence that employees have
received orientation to the center's personnel policies and emergency medical
procedures during the first week of employment.
(6) Staffing.
(a) The center shall have a staff that
includes a medical director, at least one (1) nurse-midwife and at least one
(1) registered nurse. In centers where an obstetrician provides perinatal care,
a nurse-midwife is not required. The center shall employ such other staff or
ancillary personnel that are necessary to provide the services essential to the
center's operation. Staffing schedules, time worked schedules and on-call
records shall be maintained and available in the center at all times. These
records shall be maintained for three (3) years.
1. Medical director. The center shall have a
medical director who is a licensed physician with experience in obstetrics and
newborn care. If the medical director is not a practicing board-eligible or
board-certified obstetrician, the center shall have a written agreement with a
board-eligible or board-certified obstetrician and pediatrician for
consultation, referral, and, if necessary, hospital admission. If the medical
director is a practicing obstetrician or a practicing board-eligible or
board-certified obstetrician, the center shall have a written agreement with a
board-eligible or board-certified pediatrician. Either the medical director,
consultant obstetrician or pediatrician shall have admitting privileges in a
local hospital which offers obstetrics services.
2. Nurse-midwife. Nurse-midwife services
shall be provided within the respective scope of practice pursuant to KRS
Chapter 314 and administrative regulations promulgated thereunder. There shall
be written protocols developed by the nurse-midwife and medical director and
approved by the medical director. These protocols shall be reviewed, revised,
signed and dated on an annual basis.
3. Nursing services shall be provided by
licensed nurses within their respective scope of practice pursuant to KRS
Chapter 314 and any administrative regulations promulgated thereunder. Nurses
shall have at least one (1) year of experience in perinatal care.
(b) In-service training. The
licensee shall provide ongoing in-service training programs for all personnel
relating to their respective job activities. These programs shall emphasize
professional competence and the human relationship necessary for effective
health care.
(7) Medical
records. The center shall maintain a medical record for pregnant women and
mothers to include at least the following:
(a)
Prenatal history to include any physical or health problems;
(b) Past medical, menstrual, obstetric,
contraceptive and immunization history including progress of current
pregnancy;
(c) Complete initial
physical examination including blood pressure, weight, height, examination of
skin, eyes, teeth, throat, neck, thyroid, breasts, heart, lungs, abdomen,
height of fundus, fetal position and auscultation, pelvic adequacy, including
rectum and size of uterus, fetal heart sounds, edema, and determination of
gestational age;
(d) Initial
laboratory tests to include hemoglobin or hematocrit and white blood count,
urinalysis for sugar and protein determination, pap smear, serologic tests for
syphilis and rubella antibody titer, blood type, Rh factors and screen for Rh
and irregular antibodies, when indicated, tuberculin skin test and chest x-ray
or evidence of physician follow-up when skin test is positive, sickle cell test
when indicated and gonorrhea culture;
(e) Nutritional assessment;
(f) High risk identification and
referral;
(g) Records of subsequent
visits with recorded weight, blood pressure, urinalysis for protein, sugar,
height of fundus, abdominal findings on palpation; rate and location of fetal
heart tones, estimation of gestational age, edema, unusual signs, symptoms or
quickening, third trimester hemoglobin or hematocrit, repeat venereal disease
test, Rh and irregular antibody screen for Rh negative un-sensitized women; and
repeat antibody titers at twenty-six (26) weeks, thirty-two (32) weeks, and
thirty-six (36) weeks;
(h)
Parturient initial record of intercurrent problems, physical examination,
temperature, pulse, respiration, blood pressure, head, heart, lungs, abdomen
for lie and presentation position, fundal height and engagement, reevaluation
of pelvic adequacy, recording of time of ruptured membranes, record of
hemoglobin or hematocrit and urine for protein and sugar;
(i) Progress of labor, monitoring of
contractions and fetal heart rate, dilation, effacement, station, urinary
output, medications, complications and action taken;
(j) Delivery time, newborn's Apgar score,
episiotomy, placenta delivery time, medications given, abnormalities, and any
complications along with actions taken;
(k) Puerperium-time records for at least six
(6) hours, including postpartum blood pressure, respirations, pulse,
temperature, urine output, report of breasts and breastfeeding status, legs for
thrombophlebitis, hemoglobin or hematocrit, appropriate RhD immune globin
administration at the center; record of follow-up assessment within seventy-two
(72) hours; and
(l) A four (4) to
six (6) week follow-up examination to include record of weight, blood pressure,
breast, abdominal, pelvic including rectal examination, appropriate cervico
vaginal cytologic study, hematocrit or hemoglobin, and urinalysis.
(8) A health report of the newborn
shall be maintained and include the following:
(a) Duration of ruptured membranes;
(b) Maternal antenatal blood serology,
rubella titer, blood type, Rh factors and when indicated, a Coombs
Test;
(c) Complete description of
the progress of labor and delivery (including complications, if any);
(d) Condition of the newborn infant including
the Apgar score, resuscitation, time of sustained respirations, (where
indicated, details of physical abnormalities, pathological states observed and
treatments given before transfer to appropriate nursery);
(e) Any abnormalities of placenta and cord
vessels;
(f) Date and hour of
birth, birth weight, sex, and period of gestation;
(g) Written verification of eye prophylaxis
pursuant to
902 KAR 4:020 (or
documentation of refusal based on religious belief with parent
signature);
(h) Report of initial
physical examination including any abnormalities;
(i) Discharge-physical examination including
weight, head circumference and body length unless previously recorded,
recommendations and designation of responsible physician for care immediately
upon discharge and thereafter; and
(j) Progress notes describing first and
subsequent feedings type, time of first voiding, stools passage, body
temperature, Vitamin K prophylaxis, blood metabolic screen for phenylketonuria
and hy-pothyroidism, galactosemia (documentation of parental refusal for
religious reasons including parent signature in record), notations of abnormal
respiratory rate, dyspnea, color, cyanosis, periodic pallor, lethargy,
vomiting, condition of eyes, umbilical cord and other relevant factors as
indicated by the condition of the newborn.
(9) In the event emergency hospital care is
needed during the pregnancy, delivery, or postdelivery period, the pregnant
woman or mother's record or a complete copy of the record must accompany the
pregnant woman or mother or newborn at the time of transfer.
(10) All health records shall be safeguarded
against loss, destruction or unauthorized use.
(11) Patient records of mother and newborn
shall be maintained at the center for five (5) years or in case of a minor
mother, three (3) years after the patient reaches the age of majority under
state law, whichever is the longest.
(12) An up-to-date register of all deliveries
shall be maintained and contain the following information:
(a) Infant's full name, sex, date, time of
birth and weight;
(b) Mother's full
name, including maiden name, address, birthplace and age at time of this
birth;
(c) Father's full name,
birthplace, and age at time of this birth, if provided; and
(d) Full name of attending physician or
nurse-midwife.
(13) A
certificate of birth shall be filed in accordance with the provisions of KRS
Chapter 213 and administrative regulations promulgated thereunder.
(14) Linkage agreements. The center shall
have linkages through written agreements with providers of other levels of care
which may be medically indicated to supplement the services available in the
center. These linkages shall include:
(a)
Hospital(s);
(b) A board-eligible
or board-certified obstetrician and pediatrician unless the medical director is
a practicing board-eligible or board-certified obstetrician;
(c) A board-eligible or board-certified
pediatrician if the medical director is a practicing obstetrician or a
practicing board-eligible or board-certified obstetrician;
(d) Registered pharmacist; and
(e) Licensed emergency medical transportation
services with appropriate equipment for transporting pregnant woman/mother and
infant.
Section 4. Provision of Services.
(1)
Medical services.
(a) Perinatal services shall
be available twenty-four (24) hours a day, seven (7) days a week on an on-call
basis.
(b) There shall be
sufficient staff coverage for all aspects of the center in keeping with the
size and scope of the operation.
(2) Nursing services.
(a) A nurse-midwife or physician and a
registered nurse shall be on duty at all times when a pregnant woman is
laboring in the center. A registered nurse shall be present at all times when a
woman or mother and newborn are at the center. The registered nurse shall have
at least one (1) year of perinatal experience.
(b) The center shall insure that phones are
answered twenty-four (24) hours a day, seven (7) days a week, in order to alert
the on-call staff. Telephone numbers of emergency services and staff shall be
posted by all telephones in large legible print.
(3) Laboratory services.
(a) The center shall provide laboratory
services either directly, through arrangement with a laboratory in a licensed
hospital or a medical laboratory licensed pursuant to KRS Chapter 333. If
laboratory services are provided directly, the laboratory shall be licensed
pursuant to KRS Chapter 333.
(b) If
services are provided through arrangement with other providers, a copy of the
signed and dated report shall be included in the patient's medical record.
Laboratory tests conducted at the center shall be entered in the patient's
record, dated, and signed by the individual performing the test.
(4) Radiology services. Radiology
services shall be provided directly or through arrangement. The radiology
service and personnel shall have a current license or registration pursuant to
KRS
211.842 and
211.890 and any
administrative regulations promulgated thereunder, as applicable. A signed and
dated report of any radiology examination shall be entered into the pregnant
woman's or mother's record.
(5)
Drug distribution.
(a) There shall be a list
approved by the medical director of all drugs and biologicals including
intravenous solutions which are retained for use in the center.
(b) The list of drugs and biologicals shall
include the identity of center staff authorized to administer the drugs,
biologicals and intravenous solutions. Oxytocic drugs shall not be used to
induce or augment labor.
(c) Drugs
and biologicals shall be administered only by persons legally
authorized.
(d) Drugs and
biologicals shall be stored in a locked cabinet and, when refrigeration is
necessary, they shall be stored in a locked container in a
refrigerator.
Section 5. Compliance with Building Codes, Ordinances and Regulations.
(1) Nothing stated herein shall relieve the
licensee from compliance with building codes, ordinances, and regulations which
are enforced by city, county, or state jurisdiction.
(2) The following requirements shall apply
where applicable and as adopted by the respective agency authority:
(a) Requirements for safety pursuant to 815
KAR 10:020, as amended;
(b)
Requirements for plumbing pursuant to
815 KAR
20:010 through 191, as amended;
(c) Requirements for making buildings and
facilities accessible to and usable by the physically handicapped pursuant to
KRS
198B.260 and administrative regulations
promulgated thereunder.
(3) The facility shall be currently approved
by the Fire Marshal's Office in accordance with the Life Safety Code before
licensing or relicensure is granted by the licensing agency.
(4) All facilities shall receive any
necessary approval from appropriate agencies prior to occupancy and
licensure.
Section 6. Clinical Facilities.
(1) Examination room(s).
At least one (1) examination room shall be provided. Each room shall have a
minimum clear floor area of eighty (80) square feet excluding such other spaces
as vestibule, toilet, closet, and work counter. Arrangement shall permit at
least thirty (30) inches of clear space at each side and at the foot of
examination table. A lavatory or sink with handwashing facility and counter or
shelf space for writing shall be provided.
(2) Birthing room(s). There shall be at least
two (2) birthing rooms each with a minimum clear floor area of 225 square feet
exclusive of fixed and movable cabinets and shelves and with a minimum
dimension of fifteen (15) feet.
(3)
Each birthing room shall be equipped with the following:
(a) Adequate lighting, including a spotlight
suitable for use during delivery;
(b) Infant warmer with radiant heat
source;
(c) Resuscitation equipment
for mother and infant;
(d) Oxygen
with a selection of mask sizes;
(e)
Suction equipment for mother and newborn;
(f) Intubation equipment for mother and
newborn; and
(g) Wall clock with a
second hand.
(4) The
service areas for the birthing room shall include:
(a) Sterilizing facilities with high speed
autoclave(s) conveniently located to serve all birthing rooms;
(b) Scrub facilities provided near the
birthing room entrance;
(c) A clean
holding room for storage and distribution of clean supply materials;
and
(d) A soiled holding room as
part of a system for the collection and disposal of soiled materials.
(5) Formula room. The following
shall be provided unless commercially-prepared formula is used:
(a) Work counter with built-in sink with
gooseneck-type spout and knee or foot control;
(b) Lavatory;
(c) Hot plate;
(d) Refrigerator;
(e) Sterilizer (autoclave); and
(f) Bottle washer.
(6) Physical and sanitary environment.
(a) The condition of the physical plant and
the overall center environment shall be maintained in such a manner that the
safety and well being of patients, personnel and visitors are assure.
(b) A person or persons shall be designated
as responsible for each of the following areas:
1. Plant maintenance;
2. Housekeeping; and
3. Laundry operations (if
applicable).
(c) The
center shall develop written infection control policies and procedures to
minimize and control possibilities of infection which shall include:
1. The sterilization of supplies;
2. Policies for the protection of patients
from employees who have a communicable disease; and
3. Infection control measures including birth
room cleaning and waste disposal.
(d) The center building, equipment and
surroundings shall be kept in a condition of good repair, neat, clean, free
from all accumulations of dirt and rubbish, and free from foul, stale or musty
odors.
1. Written housekeeping procedures
shall be established for cleaning of all areas and copies shall be made
available to personnel.
2.
Equipment and supplies shall be provided for cleaning of all surfaces. Such
equipment shall be maintained in a safe sanitary condition.
3. Hazardous cleaning solutions, compounds
and substances shall be labeled, stored in proper containers and kept separate
from other cleaning materials.
(e) The center shall have available at all
times a quantity of linen essential to the proper care and comfort of patients.
1. Linens shall be handled, stored, and
processed so as to control the spread of infection.
2. Clean linen and clothing shall be stored
in clean, dry, dust-free areas designated exclusively for this
purpose.
3. Soiled linen and
clothing shall be placed in suitable bags or closed containers and stored in an
area designated exclusively for this purpose.
(f) The center shall have an emergency source
of lighting for exam, labor, and birthing room(s) to protect the health and
safety of the pregnant woman or mother in the event the normal supply is
interrupted.
(g) The center shall
establish a written policy for the handling and disposal of waste materials.
Any incinerator used shall be in compliance with
401 KAR 59:020
or
401 KAR
61:010, as applicable.
STATUTORY AUTHORITY: KRS 216B.042, 216B.105
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