N.Y. Comp. Codes R. & Regs. tit. 10 § 405.12

Current through Register Vol. 46, No. 43, October 23, 2024

Section 405.12 - Surgical services

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.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.12

Amended New York State Register November 13, 2019/Volume XLI, Issue 46, eff. 11/13/2019

Amended New York State Register July 19, 2023/Volume XLV, Issue 29, eff. 7/19/2023