a) Provision of Care
1) All hospitals licensed as general
hospitals by the Department shall provide for the admission, medical care,
transfer or discharge of obstetric and neonatal patients.
2) No hospital shall fail to provide
obstetric or neonatal care without the written consent of the Director or the
Director's designee.
3) Each
hospital providing perinatal services shall comply with the perinatal care
standards in the Regionalized Perinatal Health Care Code.
4)
Every hospital shall ensure that
it has the proper instruments available for taking a pregnant women's blood
pressure. (Section 11.1 a of the Act)
b) Location
1) Obstetric and neonatal services shall be
located and arranged to provide maximum protection for obstetric and neonatal
patients from infection and cross-infection from one another, patients in other
services of the hospital and staff and visitors.
2) Obstetric and neonatal facilities shall be
located in an area of the hospital that prevents through-traffic to any other
part of the hospital.
c)
Adequacy of Services
The hospital shall have well-organized obstetric and neonatal
services that are adequately supervised by qualified personnel and with the
necessary space, facilities, equipment, and personnel to provide obstetric and
neonatal services in compliance with the hospital's designated level of care
pursuant to the Regionalized Perinatal Health Care Code.
d) Obstetric and Neonatal Service Plan
1) Hospitals providing obstetric and neonatal
services shall develop a plan for the management of the obstetric and neonatal
patients that meets the requirements of this Subpart and the requirements of
the Regionalized Perinatal Health Care Code applicable to the hospital's level
of care, as designated by the Department. The plan shall be developed by the
nursing department and medical staff and shall be approved by the governing
authority of the hospital.
2) The
hospital's written Obstetric and Neonatal Service Plan and level of care shall
be known to medical staff and nursing personnel to obstetric and nursery
personnel. A copy of the Plan shall be available in each obstetric and nursery
unit and in every relevant hospital service area; the Plan shall be reviewed at
least every three years and revised as indicated by the review.
e) Levels of Care
1) Care shall be provided to obstetric and
neonatal patients according to the following levels level of specialized care
as defined in the Regionalized Perinatal Health Care Code:
A) Non-Birthing Center hospitals do not
provide perinatal services, but have a functioning emergency department. A
letter of agreement shall delineate, but is not limited to, guidelines for
transfer/transport of perinatal patients who are transferred to an appropriate
perinatal care hospital in accordance with the non-birthing center hospital's
letter of agreement with an Administrative Perinatal Center.
B) Level I hospitals provide care to low-risk
pregnant women and newborns, operate general care nurseries and do not operate
a Neonatal Intensive Care Unit (NICU) or a Special Care Nursery
(SCN).
C) Level II hospitals
provide care to women and newborns at moderate risk, operate intermediate care
nurseries and do not operate a NICU or an SCN.
D) Level II hospitals with Extended Neonatal
Capabilities (IIE) provide care to women and newborns at moderate risk and do
operate an SCN but do not operate a NICU.
E) Level III hospitals care for patients
requiring increasingly complex care, operate a NICU, and provide
multidisciplinary consultation and supervision for those patients with medical
and surgical problems that require highly specialized treatment and highly
trained personnel.
2)
Service Management Plan
A) A service
management plan shall be provided for all levels of care for all patients. The
plan shall provide for consultation services and shall establish the services
for early diagnosis of obstetric, fetal and neonatal problems. The plan shall
include an infection control risk assessment and policy and procedures if the
hospital allows water births. Hospitals that are not designated to provide all
levels of care shall maintain plans for the safe transfer of patients who
require a higher level of care to hospitals with more specialized facilities,
services and personnel, pursuant to the Regionalized Perinatal Health Care
Code.
B) When the condition
permits, a patient may be transferred from the Level III facility to a Level II
facility that is nearest the family residence or another facility that can
provide the appropriate level of care, in accordance with the Regionalized
Perinatal Health Care Code.
f) Infection Control
1) The hospital shall follow procedures
approved by the hospital's infection control committee, including procedures
for the isolation of known or suspected cases of infectious disease in the
obstetric and neonatal departments.
2) The hospital shall establish policies and
procedures for infection control in the obstetric and neonatal departments that
are consistent with the Guidelines for Perinatal Care; Section
250.1100 of this
Part; the Control of Tuberculosis Code; and the recommendations in the American
Academy of Pediatrics Red Book, Report of the Committee on Infectious
Diseases.
3) The policy for
infection control in the obstetric and neonatal departments shall include, but
not be limited to, the following:
A) Health
personnel shall:
i) Show evidence of prior
rubella infection or rubella vaccination and comply with the health
assessment
and immunization requirements of Section
250.450
(Personnel Health Requirements). Health care personnel in obstetric and
neonatal services shall comply with any additional requirements for health and
immunizations, pursuant to the hospital's policies and procedures for infection
control in the obstetric
department;
ii) Wash hands to the elbows with an
antiseptic agent using a procedure developed and posted by the infection
control committee before entering the nursery at the beginning of a shift, and
before handling infants for the first time. Hands shall be washed before and
after touching each infant and after touching any object. Fingernails shall be
kept short. Artificial fingernails or anything other than clear polish is not
acceptable;
iii) Remove all rings,
watches and bracelets before hand washing and entering the nursery.
B) The hospital's infection
control committee shall establish a dress code for employees and visitors in
compliance with the Guidelines for Perinatal Care.
C) An infected newborn shall be placed in an
isolation
room with separate scrub facilities if the following conditions are
not met in the newborn nursery (see Section
250.2440(h)
for additional requirements):
i) Adequate
nursing and medical staff for unhurried movement between patients;
ii) Adequate time for thorough hand washing
between patients and gowning;
iii)
Sufficient space (4 to 6 feet) for easy movement between patients so that staff
will not move from one patient to another without hand washing;
iv) A continuing program of instruction for
all nursery personnel on the mode of spread of infections; and
v) At least two sinks for each nursery
room.
D) The hospital
shall develop infection control guidelines consistent with the Guidelines for
Perinatal Care for infants born outside the hospital, other than transfers, or
under conditions not aseptic, or born of mothers with membranes ruptured 24
hours or more, or born of mothers suspected of harboring infectious disease,
with careful attention to proper aseptic technique of attending personnel and
to conditions described in subsection (f)(3)(C) of this Section.
E) Infection control for the obstetric
department shall include procedures for disinfection of patient areas
consistent with Guidelines for Perinatal Care and the unit's procedures
manual.
F) Policies and procedures
for water births shall include an infection control risk assessment by the
hospital's infection control committee to identify potential sources of
infection for the mother and infant and recommendations for mitigating
infections during water deliveries. The policies and procedures shall be
provided to the Department, upon request.
g) Combined Facilities
1) Obstetric and clean gynecologic service
facilities may be combined in accordance with a plan that complies with the
requirements of this Subpart. The combined service program, its functional
operations and detailed requirements shall be approved by the hospital
obstetric and newborn service, medical staff, and governing
authority.
2) In combined programs,
caesarean section and obstetrically related surgery, other than vaginal
delivery, shall be carried out in a designated and approved operating or
delivery room. In combined programs, vaginal deliveries shall be carried out
only in designated and approved delivery rooms or designated and approved
operating rooms used solely for obstetric and clean gynecologic
procedures.
3) Gynecologic service
and obstetric service may be provided in a combined Obstetric and Gynecologic
Service, or clean gynecologic cases may be admitted to the postpartum nursing
unit of an obstetric service in accordance with the hospital's Obstetric and
Neonatal Service Plan.
4) Only
members of the medical staff with appropriate privileges may admit and care for
patients in combined service areas. Admission shall be strictly controlled and
be subject to the final authority delineated in the medical staff bylaws and
approved by the hospital governing authority. The hospital's infection control
committee shall provide close surveillance of the services.
5) Patients admitted to combined service
facilities of hospitals with approved programs shall be limited to:
A) Obstetric patients admitted for
delivery;
B) Clean obstetric
complications (regardless of month of gestation); and
C) Selected clean gynecologic
patients.
6) A
gynecologic and obstetric patient's eligibility for admission shall comply with
the hospital's infection control policy.
7) On a daily basis, unoccupied reserve beds
in the combined facilities shall be ready for use by obstetric patients,
pursuant to hospital policy.
8)
Patients admitted to the combined services may be taken to x-ray or other
hospital facilities for diagnostic procedures, if the procedures do not pose an
infection risk or other hazard to the patient or to other patients on the
combined service.
9) Patients may
receive postpartum or immediate postoperative care in the general recovery
room
prior to being returned to the combined service floor if the following
conditions exist (refer to Section
250.1320(a)):
A) The recovery room or intensive care unit
is a separate unit adjacent to or part of the general surgical operating suite
and delivery suite;
B) The recovery
room or intensive care unit contains no patients with known or suspected
infectious or communicable disease or other adverse conditions;
C) The recovery
room is under the
direct
supervision of the anesthesia service (see Section
250.1410);
and
D) Health care professionals
providing care to post-surgical obstetric or gynecologic patients in a separate
recovery room have training consistent with that required for health care
professionals providing care in the general recovery room.
10) Nursing care of all patients shall be
supervised by a registered nurse qualified to provide supervision.
11) Nursing care of all patients may be
provided by the same personnel.
12)
Visiting regulations for obstetric patients shall apply to all patients
admitted to the combined facilities (refer to Section
250.1830(k)).
h) Activity Records
1) The hospital shall establish and keep
daily records, including a Patient Log and the Obstetric Services Daily Census
Report, from which required reports can be prepared.
2) The Patient Log shall contain, at a
minimum, the following data on each patient admitted to the
department other
than obstetric patients:
A) Name of patient or
hospital patient number;
B)
Age;
C) Attending physician's
name;
D) Date of
admission;
E) Admitting
diagnosis;
F) Operative
procedure;
G) Discharge
diagnosis;
H) Date of
discharge;
I) Days stay;
J) Transferred off floor
Yes ___ Date __________; No ___ ; and
K) Reason for transfer.
3) An Obstetric Service Daily Census Report
shall be kept that, for each day of the month, gives the patient census (at the
census-taking hour) of:
A) obstetric patients,
including patients with clean obstetric complications;
B) gynecologic patients;
C) empty beds in the department;
and
D) total patients.
4) The hospital shall submit
required reports pursuant to the Regionalized Perinatal Health Care
Code.