Current through Register Vol. 46, No. 39, September 25, 2024
If surgical services are provided, the hospital shall
develop and keep current and implement effective written policies and
procedures regarding staff privileges consistent with provisions set forth in
section 405.4 of this Part, the
performance of surgical procedures, the maintenance of safety controls and the
integration of such services with other related services of the hospital to
protect the health and safety of the patients in accordance with generally
accepted standards of medical practice and patient care. Such policies and
procedures shall be reviewed and updated as necessary, but at a minimum
biennially.
(a)
Organization and
direction.
The surgical service shall be directed by a physician who
shall be responsible for the clinical aspects of organization and delivery of
all in-patient and ambulatory surgical services provided to hospital patients.
That physician or another individual qualified by training and experience shall
direct administrative aspects of the service.
(1) The operating room shall be supervised by
a registered professional nurse or physician who the hospital finds qualified
by training and experience for this role.
(i)
Nursing personnel shall be on duty in sufficient number for the surgical suite
in accordance with the needs of patients and the complexity of services they
are to receive and in accordance with the annual clinical staffing plan
established under paragraph (8) of subdivision (a) of section
405.5 of this Title.
(ii) A registered professional nurse
qualified by the hospital and by training and experience in operating room
nursing shall be present as the circulating nurse in any and each separate
operating room where surgery is being performed for the duration of the
operative procedure. Nothing in this section precludes a circulating nurse from
leaving the operating room as part of the operative procedure, leaving the
operating room for short periods; or, in accordance with employee rules or
regulations, being relieved during an operative procedure by another
circulating nurse assigned to continue the operative procedure.
(iii) Licensed practical nurses and surgical
technologists may perform scrub functions and may assist in circulating duties
under the supervision of the circulating nurse who is present in the operating
room for the duration of the procedure, in accordance with policies and
procedures established by the medical staff and the nursing service and
approved by the governing body.
(2) Surgical privileges shall be delineated
for all practitioners performing surgery in accordance with the competencies of
each practitioner as required by section
405.4 of this Part. The surgical
service shall maintain a roster of practitioners specifying the surgical
privileges of each practitioner. The hospital shall assure that the privileges
of the practitioner are commensurate with his or her training and
experience.
(3) In accordance with
written policies and procedures developed and implemented by the medical staff
and approved by the governing body, in any procedure presenting unusual hazard
to life based on the individual patient risk factors and complexity of the
procedure, there shall be present and scrubbed as first assistant a physician
designated by the medical staff and the governing body as being qualified to
assist in major surgery.
(4) The
surgical service policies shall clearly outline requirements for orientation
and continuing education programs for all staff and compliance with such
requirements shall be considered at the time of performance evaluation. Such
training or continuing education programs will be established that are relevant
to care provided, but will, at a minimum include instruction in safety
precautions, equipment usage and inspections, infection control requirements,
cardiopulmonary resuscitation and patients' rights requirements pertaining to
surgical/anesthesia consents.
(5)
The director shall, in conjunction with the medical staff, monitor the quality
and appropriateness of patient care and ensure that identified problems are
reported to the quality assurance committee and are resolved.
(6) Precautions shall be clearly identified
in written policies and procedures specific to the department and the post
anesthesia care unit (PACU) and include but are not limited to:
(i) safety regulations posted;
(ii) routine inspection and maintenance of
equipment;
(iii) availability in
the operating room suites and PACU of appropriate resuscitation, airway and
monitoring equipment including a resuscitation cart with age and size
appropriate medications, equipment and supplies; and
(iv) control of traffic in and out of the
operating room suites and accessory services to eliminate through
traffic.
(b)
Operation and service delivery.
Policies governing surgical services shall be designed to
assure the achievement and maintenance of generally accepted standards of
medical practice and patient care. The policies shall assure that service and
equipment routinely available in the operating suite and PACU are age and size
appropriate.
(1) The operating room
register shall be kept complete and up-to-date.
(2) There shall be a complete history and
physical work-up in the chart of every patient prior to any surgery except
emergency surgery. Each record shall document a review of the patient's overall
condition and health status prior to any surgery including the identification
of any potential surgical problems and cardiac problems. If this has been
dictated, but not yet recorded in the patient's chart, there shall be a
statement to that effect and an admission note in the chart by the practitioner
who admitted the patient. Such reports shall be signed to attest to the
adequacy and currency of the history and physical or countersigned by the
attending surgeon, prior to surgery.
(3) Informed consent shall be obtained from
the patient, and a properly executed informed consent form for the operation
that includes the identification of the practitioner(s) performing the surgical
procedure(s) shall be in the patient's chart before surgery except in
emergencies in accordance with section
405.7 of this Part.
(4) An operative report describing
techniques, findings, complications, tissues removed or altered and the general
condition of the patient shall be written or dictated immediately following
surgery and signed by the surgeon.
(5) Findings of any pathology reports shall
be recorded in the patient's medical record and a procedure established and
implemented for reporting unusual findings to the patient's attending
practitioner or surgeon.
(6) All
infections of clean surgical cases shall be recorded and reported to the
infection control officer. A procedure shall be developed and implemented for
the investigation of such cases.
(c)
Voluntary termination of
pregnancy.
(1) No termination of
pregnancy shall be performed until a woman has had a complete physical
examination with appropriate tests for a positive pregnancy and a determination
of gestational age including the use of sonography where there is a question of
gestational age.
(2) The standards
for preprocedure examination, post-procedure evaluation, counseling for family
planning services and birth control options, evaluation, treatment, and
determination of blood group and Rh type established in section
756.3 of this Title shall be
applicable to all terminations of pregnancy performed in hospitals.
(3) When a patient is admitted for an induced
termination of pregnancy, the determination of blood group and Rh type shall
have been made prior to the admission and shall have been recorded in the
patient's chart. If not done, such determination shall be made as soon after
admission as practicable, and prior to the termination of pregnancy. The
patient shall be evaluated for the risk of sensitization to Rho(D) antigen, and
if the use of Rh immune globulin is indicated, and the patient consents, an
appropriate dosage thereof shall be administered to her as soon as possible
within 72 hours after the termination of pregnancy.