SECTION 310:667-25-1. Department of surgery

  The department of surgery shall have effective policies and procedures regarding surgical privileges, maintenance of the operating rooms, and evaluation of the surgical patient.

(1)   Surgical privileges shall be delineated for all physicians and practitioners doing surgery in accordance with the competencies of each physician or practitioner. A roster of physicians and practitioners, specifying the surgical privileges of each, shall be kept in the confidential files of the operating room supervisor and in medical staff credential records.

(2)   In any procedure with unusual hazard to life, as defined by the medical staff, there shall be present and scrubbed as first assistant a physician designated by the credentials committee as being qualified to assist in major surgery.

(3)   Second and third assistants at major operations, and first assistants at lesser operations, may be nurses, technicians, or other practitioners if designated by the medical staff as having sufficient training to properly and adequately assist at such procedures.

(4)   The operating room log shall be complete and up to date and include the following information:

(A)   Patient's name.

(B)   Medical record number.

(C)   Name of surgeon.

(D)   Name of assistant(s).

(E)   Type of anesthetic and person administering.

(F)   Circulating nurse.

(G)   Scrub nurse.

(H)   Procedures performed.

(I)   Time surgery began and ended.

(J)   Other people present.

(5)   There shall be an appropriate history and physical examination in the chart of every patient prior to surgery (whether the surgery is major or minor). If such has been transcribed, but not yet recorded in the patient's chart, there shall be a statement to that effect and an admission note by the physician or licensed independent practitioner in the chart.

(6)   A properly executed consent form for the operation shall be in the patient's chart prior to surgery.

(7)   There shall be adequate provisions for immediate post-operative care.

(8)   An operative report describing techniques and findings shall be written or dictated immediately following surgery and signed by the surgeon.

(9)   The surgical service shall cooperate with the infection control program in the investigation and correction of problems identified through infection control surveillance activities.

(10)   The operating rooms shall be supervised by an experienced registered nurse.

(11)   Surgical technicians and licensed practical nurses may be permitted to serve as "scrub nurses" under the direct supervision of a registered nurse; they shall not be permitted to function as circulating nurses in the operating room.

(12)   The following equipment shall be available to the operating suites: call-in system, cardiac monitor, resuscitator, defibrillator, aspirator, thoracotomy set, and tracheotomy set. Thoracotomy set and tracheotomy set shall be defined by the medical staff and include instruments and supplies deemed necessary.

(13)   The operating room suite and accessory services shall be so located that traffic in and out can be and is controlled, and there shall be no through traffic.

(14)   Rules and regulations and/or policies related to the operating rooms shall be available and posted.

(15)   The service shall be responsible for central sterile supply and shall adhere to the following:

(A)   Sterilization equipment shall be provided which is adequate to properly sterilize the instruments and other supplies.

(B)   Chemical, biological, and mechanical process indicators appropriate to the type of sterilizer shall be used to indicate items have been subjected to sterilization conditions. A sterilization process indicator shall be placed within each package to be sterilized. If the internal process indicator is not visible from the outside of the package, a separate indicator should be used on the outside of the package.

(C)   Equipment for all sterilization methods shall be used, maintained, and monitored according to the manufacturer's written instructions. Sterilized items and packages shall be cooled, aerated, rinsed, dried, or otherwise handled according to the method of sterilization and manufacturer's instructions after sterilization.

(D)   Each facility shall establish policies and procedures which describe the interval(s) during which sterile items are considered to remain sterile. Such policies may be event-related or time-related. Policies for event-related shelf life labeling shall take into consideration environmental sources of contamination, barrier properties of packaging materials, storage and distribution practices, inventory control, and frequency of handling between distributor and the user. Inventory control practices shall include a requirement that stock be rotated on a first in, first out basis and a lot control system shall be established to allow for traceability of the contents of each sterilized load in the event of a sterilizer failure or malfunction.

(E)   Written or graphic records shall be maintained for each operation of the sterilizer, showing mechanical monitoring of temperature, exposure time, pressure, humidity, chemical concentrations, and/or air removal as appropriate. Records shall also include the date and time for each operation, with other pertinent data, and the signature of the operator of the sterilizer.

(F)   Periodic bacteriological testing of sterilizer performance shall be conducted at least weekly using a biologic indicator appropriate to the type of sterilizer and as recommended by the manufacturer. The results of all biological indicator tests shall be interpreted by qualified individuals in accordance with the manufacturer's instructions. Records of biological indicator testing shall include at least the date and time of the test, the identity of the sterilizer used, the test result, the identity of the individual interpreting the test, and a description of any corrective actions taken as a result of the test.

(G)   Written policies and procedures shall be established and followed for the recall of reprocessed items in the event of a sterilization failure.

[Source: Added at 12 Ok Reg 1555, eff 4-12-95 (emergency); Added at 12 Ok Reg 2429, eff 6-26-95; Amended at 20 Ok Reg 1664, eff 6-12-03]