Mo. Code Regs. Ann. tit. 19, § 30-30.020
PURPOSE: The Division of Health Resources, Department of Health 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 publication of the full text of the material that the adopting agency has incorporated by reference in this rule would be unduly cumbersome or expensive. Therefore, the full text of that material will be made available to any interested person at both the Office of the Secretary of State and the office of the adopting agency, pursuant to section 536.031.4, RSMo. Such material will be provided at the cost established by state law.
(1) Organization, Administration, Medical Staff, Nursing Staff and Supporting Services.
(A) Governing Body.
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.
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.
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.
its bylaws that the ambulatory surgical center and medical staff abide by acceptable professional ethical standards.
Health shall have access to inspect the ambulatory surgical center during normal working hours.
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.
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.
ble 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.
be posted throughout the ambulatory surgical center.
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 SMOK- ING signs.
all patients admitted to the facility are under the care of a physician who is a member of the staff.
written procedures for receiving and investigating complaints regarding the facility, its physicians, dentists, podiatrists and employees practicing or working in the facility.
individual duly qualified to act in his/her capacity during his/her absence.
provision of adequate equipment in good repair within the facility to provide efficient services and protection to the patient and staff.
tained on each employee and shall include job application, professional licensing information and health information.
er health facility, essential medical information, including diagnosis, is to be transmitted with the patient to insure continuity of care.
(B) Medical Staff.
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.
shall be a physician, dentist or podiatrist legally licensed to practice in Missouri.
shall submit a written application for staff membership on an approved form to the governing body.
formed 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.
able to the governing body and other officers and committees as is deemed necessary to meet the goals of the ambulatory surgical center.
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.
maintenance of complete records on each patient.
professional ethical standards established, defined and approved by the medical staff.
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.
policies for the recommendation of discharge of a member by the governing body.
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.
through a committee, shall review and evaluate the quality and appropriateness of all aspects of medical care given at the facility.
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.
service under the direction of a professional RN with postgraduate education or experience in surgical nursing.
sional RN on duty in the ambulatory surgical center at all times a patient is in the facility.
sistent with generally accepted nursing practices are to be developed for the direction and guidance of nursing personnel.
er nursing personnel involved in patient care shall be under the direct supervision of a professional RN.
er than the individual administering anesthesia shall be available in each operating room during surgical procedures.
recovery room during the patients’ postanesthetic recovery period at a ratio of no more than four (4) patients to one (1) nurse.
with the location, operation and use of electrocardiogram (EKG or ECG) equipment, pulse oximeter, blood pressure equipment and emergency and resuscitative equipment.
review and evaluation on a regular basis of the quality and appropriateness of nursing services.
(D) Emergency Equipment.
dle 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, inhalation-resuscitation equipment, emergency tray and equipment for use in airway obstructions.
insure that emergency equipment is kept in good working order.
(E) Anesthesia Service.
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.
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.
istration 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.
sia, 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.
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 that no 19 CSR 30-30
flammable anesthetics will be administered and the area is posted to that effect, safety inspections will not be required.
by anesthesiologists, physicians with training or experience in the administration of anesthetics or certified registered nurse anesthetists, except for local anesthetic agents which may be administered by the attending physician, dentist or podiatrist.
discharge from the recovery service shall be approved by the medical staff.
review and evaluation on a regular basis of the quality and scope of anesthesia services.
(F) Medical Records.
for every patient cared for in an ambulatory surgical center.
easy accessibility and available for inspection by duly authorized representatives of the Department of Health.
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.
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.
established in writing for storage, maintenance and distribution of supplies and equipment.
not be mixed with unsterile supplies and shall be stored in dustproof and moisture-free units. They shall be properly labeled.
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, onpremises sterilizing equipment is not required other than the required highspeed sterilizer.
expiration shall be marked on all sterile supplies and unused items shall be resterilized in accordance with written policies.
(H) Radiological and Pharmaceutical Services.
the center, the rules authorized by section 192.420, RSMo shall be met. Radiation protection shall be provided in accordance with 19 CSR 20-10.010—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.
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.
under the direction of a qualified physician.
review and evaluation on a regular basis of the quality and scope of radiological and pharmaceutical services.
(I) Laboratory Services.
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.
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.
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.
the direction of a physician member of the medical staff.
(J) Supportive Services.
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.
shall comply with 19 CSR 20-1.010.
(K) Infection Control.
plinary infection control program. This shall include a person assigned primary responsibility for the program as well as medical staff participation and review of findings. The program shall include measures for presenting, identifying, investigating, reporting and controlling infections.
dures outlining infection control measures, aseptic techniques and a mechanism for reporting and monitoring infections shall be developed.
shall be provided to all personnel on the cause, effect, transmission and prevention of infections.
review and evaluation on a regular basis of the quality and effectiveness of infection control throughout the facility.
AUTHORITY: section 197.225, RSMo 1986. 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.