Administration Standards for Ambulatory Surgical Centers

PURPOSE: The Division of Regulation and Licensure, Department of Health and Senior Services has the authority to establish standards for the operation of ambulatory surgical centers. This rule provides standards for the administration, medical staff, nursing staff and supporting services to ensure high quality services to users of ambulatory surgical centers. PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here. (1) Organization, Administration, Medical Staff, Nursing Staff and Supporting Services. (A) Governing Body. 1. The governing body is to establish and adopt bylaws by which it shall abide in conducting all business of the facility. Bylaws so adopted and changes are to be submitted to the Department of Health for its records. 2. Bylaws of the governing body shall provide for the selection and appointment of medical staff members based upon defined criteria and in accordance with an established procedure for processing and evaluating applications for membership. Applications for appointment and reappointment shall be in writing and shall signify agreement of the applicant to conform with bylaws of both the governing body and medical staff and to abide by defined professional ethical standards. Initial appointments to the medical staff shall not exceed twelve (12) months. Reappointments, which may be processed and approved at the discretion of the governing body on a monthly or other cyclical pattern, shall not exceed two (2) years. 3. The governing body shall select and employ an administrator who is a physician licensed in Missouri, a registered nurse (RN) licensed in Missouri or an individual who has at least one (1) year of administrative experience in health care; and shall notify the Department of Health of any change of administration within thirty (30) days after change has been made. 4. The governing body shall require in its bylaws that the ambulatory surgical center and medical staff abide by acceptable professional ethical standards. 5. Representatives of the Department of Health shall have access to inspect the ambulatory surgical center during normal working hours. 6. A written plan shall provide for the evacuation of patients, visitors and personnel in the event of fire or other disaster within the facility and for an alarm system to notify personnel. Personnel are to be acquainted with the evacuation plan to properly perform their duties in the event of a fire or disaster. 7. All fires occurring on the ambulatory surgical center premises shall be reported to the Department of Health within one (1) week giving the cause, location and extent of damage and personal injury, if any. 8. The administrator shall be responsible for the development and enforcement of written policies which prohibit smoking throughout the ambulatory surgical center except specific designated areas where smoking may be permitted. Each designated area shall have one hundred percent (100%) of the air supplied to the room exhausted. 9. Written smoking control policies shall be posted throughout the ambulatory surgical center. 10. Smoking shall be prohibited in any room or compartment where flammable liquids, combustible gases or oxygen are used or stored and in any other hazardous location. Those areas shall be posted with NO SMOKING signs. 11. The administrator shall assure that all patients admitted to the facility are under the care of a physician who is a member of the staff. 12. The administrator shall develop written procedures for receiving and investigating complaints regarding the facility, its physicians, dentists, podiatrists and employees practicing or working in the facility. 13. The administrator shall designate an individual duly qualified to act in his/her capacity during his/her absence. 14. The administrator shall assure the provision of adequate equipment in good repair within the facility to provide efficient services and protection to the patient and staff. 15. Personnel records shall be maintained on each employee and shall include job application, professional licensing information and health information. 16. If a patient is transferred to another health facility, essential medical information, including diagnosis, is to be transmitted with the patient to insure continuity of care. (B) Medical Staff. 1. The medical staff of an ambulatory surgical center shall be an organized group which shall initiate and adopt, with approval of the governing body, bylaws, rules and policies governing their professional activities in the facility. 2. Each member of the medical staff shall be a physician, dentist or podiatrist legally licensed to practice in Missouri. 3. Each member of the medical staff shall submit a written application for staff membership on an approved form to the governing body. 4. Surgical procedures shall be performed only by physicians, dentists or podiatrists who at the time are privileged to perform surgical procedures in at least one (1) licensed hospital in the community in which the ambulatory surgical center is located, thus providing assurance to the public that patients treated in the center shall receive continuity of care should the services of a hospital be required. As an alternative, the facility may submit a copy of a current working agreement with at least one (1) licensed hospital in the community in which the ambulatory surgical center is located, guaranteeing the transfer and admittance of patients for emergency treatment whenever necessary. 5. There shall be a chief of staff acceptable to the governing body and other officers and committees as is deemed necessary to meet the goals of the ambulatory surgical center. 6. The medical staff shall develop and utilize appropriate procedures for review and evaluation of surgical practices and techniques at least annually. In those instances when the medical staff membership numbers fewer than three (3), arrangements shall be made with the hospital medical staff where the physicians are privileged or with the medical staff of the hospital guaranteeing the transfer and admittance of patients for emergency treatment for an independent review and evaluation of surgical practices and techniques at least annually. Complete records shall be kept of these reviews and evaluations. 7. The medical staff shall assist in the maintenance of complete records on each patient. 8. The medical staff shall comply with professional ethical standards established, defined and approved by the medical staff. 9. The medical staff of each facility shall develop a policy stipulating which surgically removed tissues shall be sent to the pathologist for review. This policy shall be approved by the governing body. 10. The medical staff shall establish policies for the recommendation of discharge of a member by the governing body. 11. The medical staff bylaws shall require at least one (1) physician member of the medical staff to be on duty in the ambulatory surgical center at all times a patient is receiving or recovering from an anesthetic (local, general or intravenous sedation). Staffing shall be adequate to meet the needs of the patients. 12. The medical staff, as a body or through a committee, shall review and evaluate the quality and appropriateness of all aspects of medical care given at the facility. 13. The administrator shall bring to the attention of the chief of the professional staff any failure by members of that staff to conform with established policies of the facility regarding administrative matters, professional standards and the maintenance of adequate medical records. (C) Nursing Services. 1. There shall be an organized nursing service under the direction of a professional RN with postgraduate education or experience in surgical nursing. 2. There shall be at least one (1) professional RN on duty in the ambulatory surgical center at all times a patient is in the facility. 3. Written policies and procedures consistent with generally accepted nursing practices are to be developed for the direction and guidance of nursing personnel. 4. All licensed practical nurses and other nursing personnel involved in patient care shall be under the direct supervision of a professional RN. 5. At least one (1) professional RN other than the individual administering anesthesia shall be available in each operating room during surgical procedures. 6. At least one (1) RN shall be in the recovery room during the patients’ postanesthetic recovery period at a ratio of no more than four (4) patients to one (1) nurse. 7. Nursing personnel are to be familiar with the location, operation and use of electrocardiogram (EKG or ECG) equipment, pulse oximeter, blood pressure equipment and emergency and resuscitative equipment. 8. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of nursing services. 9. Policies shall be developed regarding the use of overtime. The policies shall be based on the following standards: A. Overtime shall not be mandated for any licensed nursing personnel except when an unexpected nurse staffing shortage arises that involves a substantial risk to patient safety, in which case a reasonable effort must be applied to secure safe staffing before requiring the on-duty licensed nursing personnel to work overtime. Reasonable efforts undertaken shall be verified by the ambulatory surgical center. Reasonable efforts shall include pursuing all of the following: (I) Reassigning on-duty staff; (II) Seeking volunteers to work extra time from all available qualified nursing staff who are presently working; (III) Contacting qualified off-duty employees who have made themselves available to work extra time, per diem staff, float pool and flex team nurses; and (IV) Seeking personnel from a contracted temporary agency or agencies when such staffing is permitted by law or an applicable collective bargaining agreement and when the employer regularly uses the contracted temporary agency or agencies; B. In the absence of nurse volunteers, float pool nurses, flex team nurses or contracted temporary agency staff secured by the reasonable efforts as described in (1)(C)9.A. and if qualified reassignments cannot be made, the ambulatory surgical center may require the nurse currently providing SENIOR SERVICES the patient care to fulfill his or her obligations based on the Missouri Nurse Practice Act by performing the patient care which is required; C. The prohibition of mandatory overtime does not apply to overtime work that occurs because of an unforeseeable emergency or when an ambulatory surgical center and a subsection of nurses commit, in writing, to a set, predetermined staffing schedule or prescheduled on-call time. An unforeseeable emergency is defined as a period of unusual, unpredictable or unforeseeable circumstances such as, but not limited to, an act of terrorism, a disease outbreak, adverse weather conditions, or natural disasters which impact patient care and which prevent replacement staff from reporting for duty; D. The facility is prohibited from requiring a nurse to work additional consecutive hours and from taking action against a nurse on the grounds that a nurse failed to work the additional hours or when a nurse declines to work additional consecutive hours beyond the nurse’s predetermined schedule of hours because doing so may, in the nurse’s judgement, jeopardize patient safety; E. Subparagraph 19 CSR 30-30.020(1)(C)9.D. is not applicable if overtime is permitted under subparagraphs 19 CSR 30-30.020(1)(C)9.A., B., and C; and F. Nurses required to work more than twelve (12) consecutive hours under subparagraphs 19 CSR 30-30.020(1) (C)9.A., B., or C. shall be provided the option to have at least ten (10) consecutive hours of uninterrupted off-duty time immediately following the worked time. (D) Emergency Equipment. 1. Equipment shall be provided to handle emergencies resulting from the services rendered in the facility. The following shall be provided as a minimum: portable ECG oscilloscope, portable defibrillator, portable suction equipment, inhalationresuscitation equipment, emergency tray and equipment for use in airway obstructions. 2. Procedures are to be developed to insure that emergency equipment is kept in good working order. (E) Anesthesia Service. 1. The anesthesia service shall be under the direction of an anesthesiologist or a physician with training or experience in the administration of anesthetics. The clinical privileges of qualified anesthesia personnel shall be reviewed by the director of anesthesia service and the medical staff and approved by the governing body. 2. An anesthesiologist or physician with training or experience in the administration of anesthetics shall be on the premises and readily accessible during the administration of anesthetics—whether local, general or intravenous sedation— and the postanesthetic recovery period until all patients are alert or medically discharged. Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care and shall continually evaluate the patient’s oxygenation, ventilation, circulation and temperature. Oxygen analyzers, pulse oximeter and electrocardiography equipment shall be available. 3. Policies and procedures on the administration of anesthetics and drugs which produce conscious and deep sedation shall be developed by the medical staff in consultation with at least one (1) anesthesiologist and approved by the governing body. 4. Prior to undergoing general anesthesia, patients shall have a history and physical examination by a physician on the patient’s record including the results of any necessary laboratory examinations. Each administration of a regional, general or intravenous sedation anesthetic shall be ordered by an anesthesiologist or a physician with training and experience in the administration of anesthetics. The patient records shall contain a preanesthetic evaluation and a postanesthetic note by qualified anesthesia personnel. 5. Periodic inspections shall be made of all areas where flammable anesthetics are administered or stored to insure safeguards are being observed by personnel and equipment meets safety standards. A written record of inspections shall be kept. If the administration of the facility provides written assurance to the Department of Health and Senior Services that no flammable anesthetics will be administered and the area is posted to that effect, safety inspections will not be required. 6. All anesthetics shall be administered by anesthesiologists, physicians with training or experience in the administration of anesthetics, certified registered nurse anesthetists or anesthesiologist assistants supervised by an anesthesiologist, except for local anesthetic agents which may be administered by the attending physician, dentist or podiatrist. Notwithstanding the provisions of sections 334.400 to 334.430, RSMo, or the rules of the Missouri State Board of Registration for the Healing Arts, the governing body of every ambulatory surgical center shall have full authority to limit the functions and activities that an anesthesiologist assistant performs in such ambulatory surgical center. Nothing in this paragraph shall be construed to require any ambulatory surgical center to hire an anesthesiologist who is not already employed as a physician prior to August 28, 2003. 7. Written procedures and criteria for discharge from the recovery service shall be approved by the medical staff. 8. There shall be a mechanism for the review and evaluation on a regular basis of the quality and scope of anesthesia services. (F) Medical Records. 1. A medical record shall be maintained for every patient cared for in an ambulatory surgical center. 2. Medical records are to be filed for easy accessibility and available for inspection by duly authorized representatives of the Department of Health. 3. The medical record shall support the diagnosis or need for medical services and shall include the following: patient identification; chief complaint, pertinent history and preoperative physician’s physical exam, including copies of any laboratory, X-ray, pathology, anesthesia record, preanesthesia and postanesthesia evaluation record and consultation reports; description of surgical procedures, treatments or observations on care provided, including complications, if any; signature or initials of physician on each clinical entry; signature or initials of nursing personnel on notes or observations; condition of patient on discharge; instructions given to patient on release from facility; copy of transfer form if patient is transferred to another health facility; and operative and anesthesia consent forms. 4. The facility shall establish and have approved by the facility governing body a medical record retention policy that meets its needs for clinical, educational, statistical or administrative purposes. All medical records shall be safeguarded against loss and unofficial use. (G) Sterilizing and Supply. 1. Policies and procedures shall be established in writing for storage, maintenance and distribution of supplies and equipment. 2. Sterile supplies and equipment shall not be mixed with unsterile supplies and shall be stored in dustproof and moisture-free units. They shall be properly labeled. 3. Sterilizers and autoclaves shall be provided of appropriate type and necessary capacity to adequately sterilize instruments, utensils, dressings, water, operating room materials, as well as laboratory equipment and supplies. The sterilizers shall have approved control and safety features. The accuracy of instruments shall be checked periodically by an approved method. Adequate surveillance methods for checking sterilization procedures shall be employed. When contractual arrangements for sterile supplies, equipment and instruments have been approved by the Department of Health, on-premises sterilizing equipment is not required other than the required highspeed sterilizer. 4. The date of sterilization or date of expiration shall be marked on all sterile supplies and unused items shall be resterilized in accordance with written policies. (H) Radiological and Pharmaceutical Services. 1. For radiology services performed in the center, the rules authorized by section 192.420, RSMo shall be met. Radiation protection shall be provided in accordance with 19 CSR 2010.010—19 CSR 20-10.200 and the recommendations of the National Council on Radiation Protection and Measurements. There shall be written policies and procedures and records shall be kept of at least annual checks and calibrations of all X-ray and gamma beam therapy equipment. Only qualified personnel shall operate radiological equipment. 2. The use of drugs in the facility shall be under the direction of a designated individual in accordance with accepted standards of practice and applicable state and federal laws. There shall be procedures relating to procuring, storage, security, records, labeling, preparation, orders, administration, adverse reactions and disposal or other disposition of drugs. There shall be specific procedures for controlled drug security and recordkeeping. 3. All radiological services shall be under the direction of a qualified physician. 4. There shall be a mechanism for the review and evaluation on a regular basis of the quality and scope of radiological and pharmaceutical services. (I) Laboratory Services. 1. Laboratory procedures performed in an ambulatory surgical center shall be limited to routine tests (such as hemoglobin, hematocrit, leucocyte count, glucose, urinalysis and pregnancy tests). Laboratory services obtained under contract shall be from a laboratory located in a hospital licensed under section 197.010, RSMo 1986 or from a laboratory certified as an independent laboratory by the federal Health Care Financing Administration. 2. Procedures performed in the facility shall be appropriate for the services provided and shall be performed according to written or printed instructions. Instructions shall include calibration and control methods that assure the accuracy and precision of each patient test. Equipment shall be calibrated and maintained in conformance with manufacturers’ instructions. All instructions shall be available in the facility. 3. The facility shall have access to a blood bank located in a hospital licensed under section 197.010, RSMo 1986 or to a regional blood center licensed by the federal Food and Drug Administration to provide blood for transfusion purposes. The blood bank or blood center shall have crossmatching capability and written procedures for investigating transfusion reactions. 4. Laboratory services shall be under the direction of a physician member of the medical staff. (J) Supportive Services. 1. Provision shall be made in writing for the laundering and processing of institutional linen and washable goods. Services may be provided by an on-premises laundry operated by the facility or by an outside laundry through contractual agreement. 2. If food services are provided, services shall comply with (K) Infection Control. 1. There shall be an active multidisciplinary infection control committee responsible for implementing and monitoring the infection control program. The committee shall include, but not be limited to, the infection control officer, a member of the medical staff, registered professional nursing staff, quality improvement staff and administration. This program shall include measures for preventing, identifying, and investigating health-care-associated infections (HAI) and shall establish procedures for: collecting data, conducting root cause analysis, reporting sentinel events and implementing corrective actions. These measures and procedures shall be applied throughout the ambulatory surgical center, including as part of the employee health program. 2. The ambulatory surgical center shall provide reports to the department as required by 19 CSR 10-33.050. 3. The infection control committee shall conduct an ongoing review and analysis of HAI data and risk factors. Priorities and goals related to preventing the acquisition and transmission of potentially infectious agents will be established based on risks identified. 4. Ambulatory surgical centers shall implement written policies and procedures outlining infection control measures for all patient care and support departments. These measures shall include, but are not limited to, an ambulatory surgical centerwide hand hygiene program that complies with the current Centers for Disease Control and Prevention (CDC) Guideline for Hand Hygiene in Health-Care Settings, which is incorporated by reference in this rule. A copy of the CDC Guideline for Hand Hygiene in Health-Care Settings may be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. This rule does not incorporate any subsequent amendments or additions. At a minimum, the program shall require every health care worker to properly wash or sanitize his or her hands immediately before and immediately after each and every episode of patient care. Procedures shall include, at a minimum, requirements for the facility’s infection control program to conduct surveillance of personnel in accordance with section 197.150, RSMo. Surveillance procedures also may include monitoring the employees’ and medical staff’s use of hand hygiene products. A mechanism approved by the ambulatory surgical center infection control committee for reporting and monitoring patient and employee infections shall be developed and implemented for all patient care and support departments in the ambulatory surgical center. 5. Orientation and ongoing education shall be provided to all personnel on the cause, effect, transmission and prevention of infections. 6. There shall be a mechanism for the review and evaluation on a regular basis of the quality and effectiveness of infection control throughout the facility. (L) Any person having a complaint pertaining to the care rendered a patient in an ambulatory surgical center may direct the complaint in writing to the Missouri Department of Health, Bureau of Hospital Licensing and Certification, P.O. Box 570, Jefferson City, MO 65102. The person making the complaint shall be contacted by the Department of Health within five (5) working days of receipt of the complaint and the complaint SENIOR SERVICES shall be investigated by the Department of Health within twenty (20) working days of receipt of the complaint. (M) Requests for deviations from the requirements of this rule shall be in writing to the Department of Health. Requests and approvals shall be made a part of the permanent Department of Health records for the facility. Licensed ambulatory surgical centers participating in innovative projects may be granted a waiver of exemption from certain requirements. Waivers may be granted by the chief of the Bureau of Hospital Licensing and Certification with the approval of the director of the Division of Health Resources. AUTHORITY: section 197.225, RSMo 2000 and 197.154, RSMo Supp. 2006.* This rule was previously filed as 13 CSR 50-30.020. Original rule filed Dec. 2, 1975, effective Feb. 1, 1976. Amended: Filed June 14, 1988, effective Oct. 13, 1988. Amended: Filed Jan. 3, 1990, effective April 12, 1990. Amended: Filed Sept. 20, 2005, effective April 30, 2006. Amended: Filed Jan. 16, 2007, effective Aug. 30, 2007. *Original authority: 197.154, RSMo 2004 and 197.225, RSMo 1975, amended 1996.