(a) Organization and supervision.

1. (1) An organizational plan shall be developed.
2. (2) Surgical services shall be under the medical direction of a qualified physician or a physician committee.
3. (3) A surgical services registered nurse supervisor shall be accountable and responsible for patient care.

4. (4)

   1. (A) Surgical services shall have written policies and procedures that include:

(i) Operative and special consents;

1. (ii) Fire and disaster plans;

   1. (iii) Environmental control;

      1. (iv) Visitor and traffic control to include allowance for no one other than staff or professionals without the expressed consent of the physician and operating room supervisor;
      2. (v) Safety practices;
      3. (vi) Infection prevention and control measures;
      4. (vii) Care and disposition of:

(b) (b) Cultures; and

1. (c) (c) Foreign bodies;

   1. (viii) Care of special equipment including preventive maintenance contracts and records;

      1. (ix) Emergency management;
      2. (x) Orientation of all personnel; and
      3. (xi) Medication accountability.

   2. (B) Refer to:

      1. (i) 20 CAR § 40-110, patient care service; and
      2. (ii) 20 CAR § 40-115, pharmacy.

2. (5)

   1. (A) Clinically relevant educational programs shall be conducted on a regularly scheduled basis of not less than twelve (12) per year.

   2. (B) There shall be evidence of:

      1. (i) Program dates;
      2. (ii) Attendance; and
      3. (iii) Subject matter.
3. (6) A surgery schedule shall be maintained in the surgery suite.
4. (7) There shall be a continuous QA/PI program that is specific to the patient care administered.

5. (8) A current roster of physicians and dentists with a delineation of each physician’s and dentist’s surgical privileges shall be accessible and available in the:

   1. (A) Confidential files of the surgical services registered nurse; and
   2. (B) Files of the hospital administrator.

6. (9) The following information shall be maintained in the surgery services log:

   1. (A) Patient’s full name;
   2. (B) Hospital number;
   3. (C) Surgeon;
   4. (D) Assistant surgeon;
   5. (E) Type of anesthetic and person administering;
   6. (F) Preoperative and postoperative diagnoses;
   7. (G) Circulating nurse;
   8. (H) Scrub nurse or nurses;
   9. (I) Procedures;
   10. (J) Complications;
   11. (K) Sponge, needle, and instrument count;
   12. (L) Time of beginning and ending of case; and
   13. (M) Other persons present.

(b) Environment, equipment, and supplies.

1. (1) A safe operating room environment shall be:

   1. (A) Established;
   2. (B) Controlled; and
   3. (C) Consistently monitored.

2. (2) At a minimum, the following general equipment and supplies shall be in the surgical suite:

   1. (A) Call-in system;
   2. (B) “Crash cart”;
   3. (C) Cardiac monitor;
   4. (D) Defibrillator;
   5. (E) Resuscitating equipment;
   6. (F) Suction equipment; and
   7. (G) Thoracotomy set.

3. (3) Equipment and supplies necessary to meet the requirements of the services provided:

   1. (A) Stretcher;
   2. (B) Anesthetic equipment and supplies;
   3. (C) Adjustable operating table with waterproof pad;
   4. (D) Side tables;
   5. (E) Approved surgical light;
   6. (F) Medical gases;
   7. (G) Twenty-four-hour supply of sterile linen;
   8. (H) Wall clock; and

   9. (I) Equipment and supplies for timed scrubbing technique.

      1. (c) Staffing.
4. (1) Surgical personnel including a registered nurse shall be available to provide emergency surgical services on a twenty-four-hour basis.

5. (2)

   1. (A) A registered nurse shall be present in the operating room for the duration of the surgical procedure.
   2. (B) Additional auxiliary personnel shall be available as necessary.
6. (3) Only qualified registered nurses may perform circulating duties in the operating room.
7. (4) There shall be documentation of training and/or experience for all operating room personnel assigned to surgical procedures.