(1) Surgical procedures must be performed in a safe manner by qualified physicians functioning within their scope of practice and who limit the surgical procedures to those that are approved by the governing body in accordance to the facility policies and procedures.

(2) The outpatient center uses acceptable standards of practice to ensure proper identification of the patient and the surgical site in order to avoid wrong site/wrong person/wrong procedure errors. Generally accepted procedures to avoid such errors include:

(a) a preprocedure verification process to make sure all relevant documents and related information are available, are correctly identified, match the patient, and are consistent with the procedure the patient and the surgical staff are expecting to perform;

(b) marking of the intended procedure site by the physician who will be performing the procedure so that is it is clear where the procedure is to be performed on the patient's body;

(c) verification that a current health history is complete which includes a list of current prescription and nonprescription medications and dosages, physical examination, and pertinent preoperative diagnostic studies have been completed; and

(d) a recheck of the procedures listed in (a) through (c).

(3) Each operating or procedure room is designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and ensures the physical safety of all persons in the area. Only nonflammable agents are to be present in the operating or procedure room.

(4) All personnel with direct patient contact will maintain skills in basic cardiac life support and are available whenever there is a patient in the facility.

(5) A safe environment for treating surgical patients, including adequate safeguards to protect the patient from cross-infection, is ensured through the provision of adequate space, equipment, supplies, and personnel including:

(a) all persons entering the operating or procedure room are properly attired as defined by the governing body;

(b) acceptable aseptic techniques are used by all persons in the surgical area;

(c) only authorized persons are allowed in the surgical or treatment areas; and

(d) measures are implemented to prevent skin and tissue injury from chemicals, cleaning solutions, and other hazardous exposure.

(6) The outpatient center has established protocols for instructing patients in self-care following surgery.

(7) The outpatient center has a procedure to address when sponge, sharps, and instrument counts will occur.

(8) Suitable equipment for rapid and routine sterilization is available to ensure the operating room materials are sterile. Sterilized materials are packaged, labeled, and stored in a manner to maintain sterility and identify sterility dates. Sterility requirements also include:

(a) processes for cleaning and sterilization of supplies and equipment must comply with manufacturer's instructions and recommendations; and

(b) internal and external indicators are used to demonstrate the safe processing of items undergoing high level disinfection and sterilization.

(9) Periodic calibration and preventive maintenance, or both of equipment is provided.

(10) An alternate source of power must be available in the event of power shortages, surges, or loss of utility.

(a) In accordance to National Fire Protection Association (NFPA) 110 Standard the outpatient center must have a generator which automatically starts within 10 seconds of loss of the utility. An Uninterrupted Power Supply (UPS) system is not acceptable as a substitute in any location using general anesthesia.

(b) UPS systems are permitted in settings where a patient is not under general anesthesia.

History: 50-5-103, MCA; IMP, 50-5-103, MCA; NEW, 2013 MAR p. 1626, Eff. 9/6/13.