| (8) Each operating room shall be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all persons in the area. (A) If flammable agents are present in an operating room the room shall be constructed and equipped in compliance with standards established by the National Fire Protection Association (NFPA 99, Annex 2, Flammable Anesthetizing Locations, 1999) and with applicable state and local fire codes. (B) If nonflammable agents are present in an operating room the room shall be constructed and equipped in compliance with standards established by the National Fire Protection Association (NFPA 99, Chapters 4 and 8, 1999) and with applicable state and local fire codes. (9) With the exception of those tissues exempted by the governing body after medical review, tissues removed during surgery shall be examined by a pathologist, whose signed report of the examination shall be made a part of the patient's medical record. (10) A description of the findings and techniques of an operation shall be accurately and completely written or dictated immediately after the procedure by the health care practitioner who performed the operation. If the description is dictated, an accurate written summary shall be immediately available to the health care practitioners providing patient care and shall become part of the patient's medical record. Refer to §135.9(p) of this title (relating to Medical Records). (11) A safe environment for treating surgical patients, including adequate safeguards to protect the patient from cross infection, shall be assured through the provision of adequate space, equipment, and personnel. (A) Provisions shall be made for the isolation or immediate transfer of patients with communicable diseases. (B) All persons entering operating rooms shall be properly attired. (C) Acceptable aseptic techniques shall be used by all persons in the surgical area. (D) Only authorized persons shall be allowed in the surgical area. (E) Suitable equipment for rapid and routine sterilization shall be available to assure that operating room materials are sterile. (F) Environmental controls shall be implemented to assure a safe and sanitary environment. (G) Operating rooms shall be appropriately cleaned before each operation. (12) Written policies and procedures for decontamination, disinfection, sterilization, and storage of sterile supplies shall be developed, implemented and enforced. Policies shall include, but not be limited to, the receiving, cleaning, decontaminating, disinfecting, preparing, and sterilization of critical items (reusable items), as well as for the assembly, wrapping, storage, distribution, and the monitoring and control of sterile items and equipment. (A) Policies and procedures shall be developed following standards, guidelines, and recommendations issued by the Association of periOperative Registered Nurses (AORN), the Association for Professionals in Infection Control and Epidemiology (APIC), the Centers for Disease Control and Prevention (CDC) and, if applicable, the Society of Gastroenterology Nurses and Associates (SGNA). Standards, guidelines, and recommendations of these organizations are available for review at the Department of State Health Services, Exchange Building, 8407 Wall Street, Austin, Texas. Copies may also be obtained directly from each organization, as follows: AORN, 2170 South Parker Road, Suite 300, Denver Colorado, 80231, (800) 755-2676; APIC, 1275 K Street, Northwest, Suite 1000, Washington, District of Columbia, 20005-4006, (202) 789-1890; CDC, 1600 Clifton Road, Atlanta, Georgia, 30333, (800) 311-3435; SGNA, 401 North Michigan Avenue, Chicago, Illinois, 60611-4267, (312) 321-5165. (B) Policies and procedures shall also address proper use of external chemical indicators and biological indicators. (C) Performance records for all sterilizers shall be maintained for a period of six months. (D) Preventive maintenance of all sterilizers shall be completed according to manufacturer's recommendations on a scheduled basis. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least one year and shall be available for review to the facility within two hours of request by the department. (13) Emergency power adequate for the type of surgery performed shall be available in the operative and postoperative recovery areas. (14) Periodic calibration and/or preventive maintenance of all equipment shall be provided in accordance with manufacturer's guidelines. (15) The informed consent of the patient or, if applicable, of the patient's legal representative shall be obtained before an operation is performed. (16) A written procedure shall be established for observation and care of the patient during the preoperative preparation and postoperative recovery period. (17) Written protocols shall be established for instructing patients in self-care after surgery, including written instructions to be given to patients who receive conscious sedation, regional, and general anesthesia. (18) Patients who have received anesthesia shall only be allowed to leave the facility in the company of a responsible adult, unless the operating surgeon or an advanced practice registered nurse writes an order that the patient may leave without the company of a responsible adult. (19) An effective written procedure for the immediate transfer to a hospital of patients requiring emergency care beyond the capabilities of the ASC shall be developed. The ASC shall have a written transfer agreement with a hospital, or all physicians on staff at the ASC shall have admitting privileges at a local hospital. |
