R432.  Health, Family Health and Preparedness, Licensing.
R432-500.  Freestanding Ambulatory Surgical Center Rules.
R432-500-1.  Legal Authority.
	This rule is adopted pursuant to Title 26, Chapter 21.

R432-500-2.  Purpose.
	The purpose of this rule is to establish standards for the operation of a freestanding surgical facility which provides surgical services to patients not requiring hospitalization.

R432-500-3.  Time for Compliance.
	All facilities governed by this rule shall be in full compliance at the time of licensure.

R432-500-4.  Definitions.
	(1)  See common definitions R432-1-3.
	(2)  Special definitions.
	(a)  "Anesthesia service" includes services for all patients who:
	(i)  receive general, spinal, or other major regional anesthesia, or
	(ii)  undergo surgery or other procedures when receiving either or both of the following:
	(A)  general, spinal, or other regional anesthesia;
	(B)  intravenous, intramuscular, or inhalation sedation or analgesia that may result in the loss of the patient's protective reflexes.
	(b)  "Continual" means repeated regularly and frequently in steady rapid succession.
	(c)  "Continuous" means prolonged without any interruption at any time.
	(d)  "Monitored Anesthesia Care" includes intraoperative monitoring by a qualified anesthetist of the patient's vital physiological signs, in anticipation of the need for administration of general anesthesia or of the development of adverse physiological patient reaction to the surgical procedure.  Monitored anesthesia care also includes performing a preanesthetic examination, evaluating, planning, and administering anesthesia services required, and providing indicated postoperative anesthesia services.
	(e)  "Qualified Anesthetist" means an anesthesiologist, another qualified physician, oral surgeon, or certified registered nurse anesthetist, who:
	(i) is licensed to provide anesthesia services in accordance with Utah laws for occupational and professional licensing,
	(ii) is a member of the staff of the ambulatory surgical center,
	(iii) has been determined by the facility to be competent,
	(iv)  has been granted privileges to provide anesthesia services to patients in the facility; and
	(v)  if the qualified anesthetist is a qualified physician or oral surgeon, has documented training that includes the equivalent of 40 days preceptorship with an anesthesiologist and is able to perform at least the following:
	(A)  safely render the patient insensible to pain during the performance of surgical, and other pain producing clinical procedures;
	(B)  monitor and sustain life support functions during the administration of anesthesia, including induction and intubation procedures; and
	(C)  provide pre-anesthesia and post-anesthesia management of the patient.
	(f)  "Extended Recovery Services" means patient care after the initial post surgery recovery period.
	(g)  "Initial Post Surgery Recovery Period" means patient care no longer than six hours beyond the completion of surgery.
	(h)  "Licensed Professional" means a qualified physician or oral surgeon who is involved in the preoperative assessment of the patient and has ensured that a qualified anesthetist is providing anesthesia services.
	(i)  "upon the request of" means a patient specific order of a licensed professional working within the scope of his license.

R432-500-5.  Licensure.
	(1)  License Required.  See R432-2.
	(2)  Exempt facilities shall meet the provisions of Section 26-21-7.  Physician based surgical centers shall request an exemption to this rule in order to apply for Medicaid/Medicare certification.

R432-500-6.  General Construction Rules.
	(1)  See R432-13. Ambulatory Surgical Center Construction Rule.

R432-500-7.  Administration and Organization.
	(1)  Direction.
	(a)  Each facility shall be operated by a licensee.
	(b)  If the licensee is other than a single individual, there shall be an organized functioning governing authority to assure accountability.
	(c)  The governing authority shall meet at least quarterly and keep written minutes of its meetings.
	(2)  Responsibilities.
	(a)  The licensee shall have the overall responsibility and authority for the organization.
	(b)  Responsibilities shall include at least the following:
	(i)  Comply with all applicable federal, state and local laws, rules and requirements;
	(ii)  Adopt and institute bylaws, operating room protocols, policies and procedures relative to the operation of the facility;
	(iii)  Appoint, in writing, a qualified administrator (the licensee, administrator, or medical director may be the same person) to be responsible for the implementation of facility bylaws, policies and procedures, and for the overall management of the facility;
	(iv)  Appoint, in writing, a qualified medical director to advise and be accountable to the licensee for the quality of patient care;
	(v)  Ensure that patients requiring hospitalization are not admitted to the facility;
	(vi)  Appoint members of the medical staff and delineate their clinical privileges.

R432-500-8.  Administrator.
	(1)  Direction.
	(a)  Each facility shall designate in writing an administrator who shall have freedom from other responsibilities to be on the premises of the facility a sufficient number of hours in the business day to manage the facility and to respond to appropriate requests by the Department.
	(b)  The administrator shall designate a person, in writing, to act as administrator in his absence.
	(i)  This person shall have sufficient power, authority, and freedom to act in the best interests of patient safety and well-being and shall be available at the facility.
	(ii)  It is not the intent to permit a de facto administrator to supplant or replace the designated facility administrator.
	(c)  The administrator shall be the direct representative of the board in the management of the facility and shall be responsible to the board for the performance of his duties.
	(2)  Qualifications.
	The administrator and his designee shall be 21 years or older and shall be experienced in administration and supervision of personnel and shall be knowledgeable about the practice of medicine to interpret and be conversant in surgery protocols.
	(3)  Duties and Responsibilities.
	(a)  The administrator's responsibilities shall be written in a job description and shall be available for Department review.
	(b)  Responsibilities shall include:
	(i)  Compliance with all applicable federal, state and local laws, and facility bylaws;
	(ii)  Develop, evaluate, update, and implement facility policies and procedures annually;
	(iii)  Maintain an adequate number of qualified and competent staff to meet the needs of patients;
	(iv)  Develop clear and complete job descriptions for each position;
	(v)  Notify appropriate authorities when a reportable disease is diagnosed;
	(vi)  Review all incident and accident reports and take appropriate action;
	(vii)  Establish a quality assurance committee that will respond to the quality and appropriateness of services and respond to the recommendations made by the committee;
	(viii)  Secure through contracts the necessary services not provided directly by the facility;
	(ix)  Receive and respond to the licensure inspection report by the Department.

R432-500-9.  Medical Director.
	(1)  Direction.
	(a)  The licensee of the surgical facility shall retain, by formal agreement, a qualified physician to serve as medical director.
	(b)  The medical director shall have freedom from other responsibilities to assume professional, organizational, and administrative responsibility.
	(c)  The medical director shall be accountable to the governing authority for the quality of services rendered.
	(2)  Qualifications.
	The physician designated as the medical director shall have at least the following qualifications:
	(a)  Be currently licensed to practice medicine in Utah;
	(b)  Have training and expertise in those branches of surgery and anesthesia services offered to provide supervision at the facility.
	(3)  Responsibilities.
	(a)  The medical director shall have overall responsibility for surgery and anesthesia services delivered in the facility.
	(b)  Applicable laws relating to use of anesthesia, professional licensure acts and facility protocols shall govern both medical staff and employee performance.
	(c)  The medical director shall be responsible for at least:
	(i)  Review and update facility protocols;
	(ii)  Periodically conduct reappraisals of medical staff privileges and revise those privileges as appropriate;
	(iii)  Recommend to the governing authority, names of qualified health care practitioners to perform approved procedures, and to recommend facility privileges to be granted;
	(iv)  Establish and maintain a quality assurance mechanism to review identified problems and take appropriate action;
	(v)  Coordinate, direct and evaluate all clinical operations of the facility;
	(vi)  Evaluate and recommend the type and amount of equipment needed in the facility;
	(vii)  Assure that a qualified physician available when patients are in the facility;
	(viii)  Ensure physician documentation is recorded immediately and reflects an accurate description of care given;
	(ix)  Assure that planned surgical procedures are within the scope of privileges granted to the physicians.

R432-500-10.  Director of Nursing Services.
	(1)  Direction.
	Each facility shall employ and designate in writing a registered nurse who will be responsible for the supervision and direction of the nursing staff and the operating room suite.
	(2)  Qualifications.
	The director of nursing shall be a registered nurse who is qualified by training or education to supervise nursing services.
	(3)  Responsibilities.
	(a)  The director of nursing, in consultation with the medical director shall plan and direct the delivery of nursing care.
	(b)  The director of nursing shall be responsible for at least:
	(i)  Maintain qualified health care personnel that are available and used as needed under the supervision of a registered nurse;
	(ii)  Assure a licensed nurse is on duty when patients are in the facility;
	(iii)  Maintain the operating room register;
	(iv)  Review and update nursing care policies and procedures;
	(v)  Ensure that nursing documentation is recorded immediately and reflects an accurate description of care given;
	(vi)  Maintain policies and procedures for pre-operative and post-operative care;
	(vii)  Ensure post-operative instructions are in writing and are reviewed with the patient or other responsible person following surgery;
	(viii)  Supervise all non-physician direct patient care services, as defined in facility policy;
	(ix)  Review identified problems with the medical director through quality assurance mechanisms and take appropriate action;
	(x)  Ensure patient care policies including admission and discharge policies are reviewed annually.  Patient care policies shall be developed and revised by a group representing all professionals involved in patient care.

R432-500-11.  Staff and Personnel.
	(1)  Health Surveillance.
	(a)  The facility shall establish a policy and procedure for the health screening of all personnel which shall protect the health an safety of personnel and patients.  Employee health screening and immunization components of personnel health programs shall be developed in accordance with R386-702. Communicable Disease rules.
	(b) The facility shall prohibit employees with a communicable disease or open skin lesions, or weeping dermatitis, from direct contact with patients, patient care items, if direct contact may result in the transmission of the infection or the disease.
	(c)  This health screening shall be performed within the first two weeks of employment and as defined in facility protocols.
	(d)  Employee skin testing by the Mantoux method or other FDA approved in-vitro serologic test and follow-up for tuberculosis shall be done in accordance with R388-804, Special Measures for the Control of Tuberculosis.
	(i)  The licensee shall ensure that all employees are skin-tested for tuberculosis within two weeks of:
	(A)  initial hiring;
	(B)  suspected exposure to a person with active tuberculosis; and
	(C)  development of symptoms of tuberculosis.
	(ii)  Skin testing shall be exempted for all employees with known positive reaction to skin tests.
	(e)  All infections and communicable diseases reportable by law shall be reported by the facility to the local health department in accordance with R386-702-2.
	(f)  The facility shall be in compliance with the Occupational Safety and Health Administrations Bloodborne Pathogen Standard.
	(2)  In-service Training and Orientation.
	(a)  There shall be planned and documented in-service training programs for all personnel.
	(b)  The frequency and content of training programs shall be defined in facility policy.
	(c)  The training program shall include a review of all facility policies and procedures.
	(d)  All personnel shall have access and knowledge of the facility's policy and procedure manuals.

R432-500-12.  Contracts and Agreements.
	(1)  Contracts.
	(a)  The licensee shall secure and update contracts for services not provided directly by the facility.
	(b)  Contracts shall include a statement that the contractor will conform to the standards required by these rules.
	(2)  Transfer Agreements.
	(a)  The licensee shall maintain hospital admitting privileges for all staff or a written transfer agreement with one or more full-service licensed hospitals located within an overall travel time of 15 minutes or less from the facility.
	(b)  The transfer agreement shall include provisions for:
	(i)  Transfer of information needed for proper care and treatment of the patient transferred;
	(ii)  Security and accountability of the personal effects of the patient being transferred.

R432-500-13.  Quality Assurance.
	(1)  The administrator and the medical director, shall establish a quality assurance program and a quality assurance committee to review facility operations, protocols, policies and procedures, incident reports, medication usage, infection control, patient care, and safety.
	(2)  General Provisions Quality Assurance Committee.
	(a)  The committee shall include a representative from the facility administration, the medical director, the director of nursing, and may also include other representatives, as appropriate.
	(b)  The committee shall meet at least quarterly and keep written minutes available for Department review.
	(c)  The committee shall report findings and concerns to the medical director, administrator, and governing authority as applicable.

R432-500-14.  Emergency and Disaster.
	Each facility has the responsibility to assure the safety and well-being of patients in the event of an emergency or disaster.  An emergency or disaster may include utility interruption, explosion, fire, earthquake, bomb threat, flood, windstorm, epidemic, and injury.
	(1)  General Provisions.
	(a)  The administrator shall be in charge of facility operations during any significant emergency.  If not on the premises, the administrator should make every effort to get to the facility to relieve the administrator designee to take charge during an emergency.
	(b)  The licensee and the administrator shall be responsible for the development of a written emergency and disaster plan, coordinated with state and local emergency or disaster authorities.
	(c)  The plan shall be made available to all staff to assure prompt and efficient implementation (see R432-500-14(2)).
	(d)  The administrator and the licensee shall review and update the plan at least annually.
	(e)  The names and telephone numbers of facility staff, emergency medical personnel, and emergency service systems shall be conveniently posted.
	(2)  Emergency and Disaster Plan and Drills.
	The facility shall have an internal and external emergency or disaster plan including the following:
	(a)  Evacuation of occupants to a safe place, as specified;
	(b)  Delivery of emergency care and services to facility occupants when staff is reduced by an emergency;
	(c)  The receiving of patients to the facility from another location, including housing, staffing, medication handling, and record maintenance and protection;
	(d)  The person or persons with decision-making authority for fiscal, medical, and personnel management;
	(e)  An inventory of available personnel, equipment, supplies and instructions and how to acquire additional assistance;
	(f)  Staff assignment for specific tasks during an emergency;
	(g)  Names and telephone numbers of on-call physicians and staff at each telephone;
	(h)  Documentation of emergency events;
	(i)  Emergency or Disaster drills, other than fire drills shall be held at least biannually, at least one per shift, with a record of time and date maintained.  Actual evacuation of patients during a drill is optional;
	(j)  Notification of the Department if the facility is evacuated.
	(3)  Fire Emergencies.
	The licensee and administrator shall develop a written fire emergency and evacuation plan in consultation with qualified fire safety personnel.
	(a)  An evacuation plan shall identify:
	(i)  evacuation routes,
	(ii)  location of fire alarm boxes and fire extinguishers, and
	(iii)  emergency telephone numbers including the local fire department.
	(b)  The evacuation plan shall be posted at several locations throughout the facility.
	(c)  The emergency plan shall include fire containment procedures and how to use the facility alarm systems, extinguishers, and signals.
	(d)  Fire drills shall be held at least quarterly on each shift and documentation of the drill shall include a record of the time and date.  Actual evacuation of patients during a drill is optional.
	(4)  Smoking Policies.
	Smoking policies shall comply with Title 26, Chapter 38 the, "Utah Indoor Clean Air Act", and Section 31-4.4 of the 1991 Life Safety Code.

R432-500-15.  Patients' Rights.
	(1)  Written policies regarding the patient rights shall be made available.
	(2)  The policies and procedures shall ensure that each patient admitted to the facility shall be treated as an individual with dignity and respect and have the following rights:
	(a)  To be fully informed, prior to or at the time of admission and during stay, of the patient rights and of all facility rules that pertain to the patient;
	(b)  To be fully informed prior to admission of the treatment to be received, potential complications, and outcome;
	(c)  To refuse treatment and to be informed of the medical consequences of such refusal;
	(d)  To be informed, prior to or at the time of admission and during stay, of services available in the facility and of any expected charges for which the patient may be liable;
	(e)  To participate in decisions involved in their health care;
	(f)  To refuse to participate in experimental research;
	(g)  To be assured confidential treatment of personal and medical records and to approve or refuse release to any individual outside the facility, except in the case of transfer to another health facility, or as required by law or third party payment contract;
	(h)  To be treated with consideration, respect, and full recognition of personal dignity and individuality, including privacy in treatment and in care for personal needs.

R432-500-16.  Patient Care Services.
	(1)  Each patient shall be under the care of a member of the medical staff or under contract.
	(2)  Medical Staff Bylaws shall establish the credentialing process and shall include the delineation of professional staff privileges.
	(3)  Responsibilities.
	(a)  The attending member of the medical staff including any non-physician specialist shall be responsible for the quality of patient care delivered and the supervision of patients admitted to the facility.
	(b)  All facility staff members and those under contract by the facility shall comply with current laws, facility protocols and current standards as interpreted by the medical director.

R432-500-17.  Extended Recovery Services.
	(1) Extended recovery care services provided by a Freestanding Ambulatory Surgical Center shall not exceed 24 hours. The facility shall provide services to no more than three patients, anywhere within the facility, between the hours of 10:00 p.m. and 6:00 a.m.
	(2) Extended recovery care services shall be integrated with other departments and services of the facility.
	(3) Extended recovery care services shall have policies and procedures that describe the nature and extent of the extended recovery services provided, which are consistent with ambulatory surgery and anesthesia services.
	(4)  A minimum of two health care workers, one of which shall be a registered nurse with Advanced Cardiac Life Support certification (ACLS), shall be on duty when patients are in the extended recovery care unit.
	(5)  In addition to the items required in a patient's medical record under section R432-500-22, the physician shall document the following:
	(a)  the reason(s) or need for a patient's admission to the extended recovery service, and
	(b) dietary orders to meet the nutritional needs of the patient.
	(6) The facility shall obtain a Food Service Establishment Permit, if required by the local health department.
	(a) Inspection reports by the local health department shall be maintained at the facility for review by the Department.
	(b)  All personnel who prepare or serve food shall observe personal hygiene and sanitation practices which protect food from contamination.

R432-500-18.  Nursing Services.
	(1)  Direction.
	Each facility shall provide nursing services commensurate with the needs of the patients served.
	(2)  Organization.
	All non-medical patient services shall be under the general direction of the director of nursing, except as exempted by facility policy.
	(3)  Responsibilities.
	(a)  Nursing service personnel shall be responsible to plan and deliver nursing care, and assist with treatments and procedures.
	(b)  All nursing personnel shall maintain a current Utah license.
	(4)  Equipment.
	(a)  The facility shall provide equipment in good working order to meet the needs of patients.
	(b)  The type and amount of equipment shall be indicated in facility policy and approved by the medical director.
	(c)  The following equipment shall be available to the operating suite:
	(i)  Emergency call system;
	(ii)  Cardiac Monitor;
	(iii)  Ventilation support system;
	(iv)  Defibrillator;
	(v)  Suction equipment;
	(vi)  Equipment for Cardiopulmonary Resuscitation and Airway Management;
	(vii)  Portable Oxygen; and
	(viii)  Emergency Cart.

R432-500-19.  Pharmacy Service.
	Pharmacy space and equipment required depends upon the type of drug distribution system used, number of patients served, and extent of shared or purchased services.
	(1)  Direction.
	(a)  There shall be a pharmacy supply under the direction of a pharmacist.
	(b)  If the facility does not have a staff pharmacist, it shall retain a consultant pharmacist by written contract.
	(c)  There shall be written policies and procedures to govern the acquisition, storage, and disposal of medications.
	(d)  The medical director and facility pharmacist shall approve these policies.
	(e)  The quality and appropriateness of medication usage shall be monitored by the Quality Assurance Committee.
	(2)  Pharmacy Supply.
	(a)  Provision will be made to supply necessary drugs and biologicals in a prompt and timely manner.
	(b)  A current pharmacy reference manual shall be available to all staff.
	(3)  Storage.
	(a)  All medications, solutions, and prescription items shall be kept secure and separate from non-medicine items in a conveniently located storage area.
	(b)  An accessible emergency drug supply shall be maintained in the facility if the facility does not have a pharmacy.
	(i)  The emergency drug supply shall be approved by the medical director and the facility pharmacist.
	(ii)  Contents of the emergency drug supply shall be listed on the outside of the container.  An inventory of the contents shall be documented by nursing staff after each use and at least weekly.
	(iii)  Used items shall be replaced within 48 hours.
	(c)  Medications stored at room temperature shall be maintained within 59 - 80 degrees F. (15 to 30 degrees C.). Refrigerated medications shall be maintained within 36 - 46 degrees F. (2 to 8 degrees C.).
	(d)  Medications and other items that require refrigeration shall be stored securely and separately from food items.
	(4)  Controlled Drugs.
	(a)  Drugs shall be accessible only to licensed nursing, pharmacy, and medical personnel as designated by facility policy.  Schedule II drugs shall be kept under double-lock and separate from other medication.
	(b)  Separate records of drug use shall be maintained on each Schedule II drug.
	(i)  Records shall be accurate and complete including patient name; drug name; strength; administration documentation; and name, title, and signature of person administering the drug.
	(ii)  The record shall be reconciled at least daily and retained for at least one year.
	(iii)  If medications are supplied as part of a unit-dose medication system, separate records are not required.
	(c)  Records of Schedule III and IV Drugs shall be maintained in such a manner that the receipt and disposition of the drugs can be readily traced.
	(5)  Disposal of Drugs.
	(a)  All discontinued and outdated drugs, including those listed in Schedules II, III or IV of the "Federal Comprehensive Drug Abuse Prevention and Control Act of 1970," shall be destroyed promptly by the facility.  The destruction shall be witnessed and documented by two licensed members of the facility staff, preferably a physician and a registered nurse designated by the facility.
	(b)  The name of the patient, the name and strength of the drug, the prescription number, the amount destroyed, the method of destruction, the date of destruction and the signatures of the witnesses shall be recorded in a separate log kept for this purpose.  The log shall be retained for at least three years.
	(6)  Administration.
	(a)  A single dose or pre-packaged medications may be sent with the patient upon discharge, when ordered by the discharging physician.
	(b)  Use of multiple dose medications shall be released in compliance with Utah pharmacy law.
	(c)  All medications used shall be documented in the patient's medical record.

R432-500-20.  Anesthesiology Services.
	(1)  There shall be facilities and equipment for the administration of anesthesia services commensurate with the clinical and surgical procedures planned for the facility.
	(2)  The medical staff shall appoint a medical director of anesthesia services who shall meet the following requirements:
	(a)  be licensed to practice medicine in Utah;
	(b)  have training and expertise in anesthesia services offered to ensure adequate supervision of patient care.
	(3)  The medical director of anesthesia services shall implement, coordinate, and ensure the quality of anesthesia services provided in the facility including the implementation of written policies and protocols approved by the medical staff which clearly define the responsibilities and privileges of qualified anesthetists.
	(4)  Only qualified anesthetists shall provide anesthesia care.
	(5)  During the surgical procedure, a qualified anesthetist shall be responsible for the following:
	(a)  monitor, by continuous presence in the operating room (except for short periods of time for personal safety, such as radiation exposure), a patient who is undergoing a surgical procedure and who is receiving general anesthetics, regional anesthetics, or monitored anesthesia care;
	(b)  continually evaluate a patient's oxygenation, ventilation, and circulation, and have means available to measure temperature during administration of all anesthetics.
	(6)  The non-physician qualified anesthetists shall provide patient specific anesthesia services upon the request of a licensed professional, as defined in R432-500-2(e).  The licensed professional shall be involved in each patient's preoperative assessment and shall ensure that the non-physician anesthetist is providing anesthesia services in a manner that specifically addresses the needs of each individual patient.
	(7)  The patient and operating surgeon shall be informed prior to surgery of who will be administering anesthesia.
	(8)  When the operating team consists entirely of non-physicians, a physician shall be immediately available in the facility to respond to medical emergencies.
	(9)  Policies and Procedures.
	(a)  Written anesthesia service policies shall include the following:
	(i)  Anesthesia care policies and procedures for preanesthesia evaluation, intraoperative care including documenting a time-based record of events, and postanesthesia care;
	(ii)  A qualified anesthetist, shall conduct a preanesthesia evaluation, and document the evaluation in the patient's medical record prior to inducing anesthesia;
	(iii)  The preanesthesia evaluation shall include the following information:
	(A)  planned anesthesia choice;
	(B)  assessment of anesthesia risk;
	(C)  anticipated surgical procedure;
	(D)  current medications and previous untoward drug experiences;
	(E)  prior anesthetic experiences;
	(F)  any unusual potential anesthetic problems.
	(b)  A qualified anesthetist shall remain with the patient until the patient's status is stable. The qualified anesthetist or the anesthetist's qualified designee shall remain with the patient until the patient's protective reflexes have returned to normal, and it is determined safe as defined in facility policy.
	(c)  The medical director of anesthesia services shall define the mechanism for the release of patients from postanesthesia care.  Each patient who is admitted to an ambulatory surgical facility, and who receives other than unsupplemented local anesthesia, shall be discharged in the company of a responsible adult.
	(10)  Medicaid certified facilities shall comply with the 42 CFR 415.110 and 42 CFR 416.42 (December 30, 1999) which is incorporated by reference.
	(11)  The use of flammable anesthetic agents for anesthesia or for the pre-operative preparation of the surgical field is prohibited.
	(12)  The anesthetic equipment shall be inspected and tested by the person administering anesthesia before use in accordance with the facility policy.

R432-500-21.  Laboratory and Radiology Services.
	(1)  General Requirements.
	(a)  The facility shall make provisions, as appropriate, for laboratory, radiology and associated services according to facility policy.
	(b)  Services shall be provided with an order from a physician or a person licensed to prescribe such services.  The order for laboratory and radiology services and the test results shall be included in the patient's medical record.
	(c)  If services are provided by contract, a CLIA certified, State- approved laboratory shall perform such services.  Reports or results shall be reported promptly to the attending physician and documented in the patient's medical record.
	(2)  Facility Laboratory Services.
	If the facility provides CLIA certified or state approved laboratory service, these services shall comply with R432-100-22.
	(3)  Facility Radiology Services.
	If the facility provides its own radiology services, these services shall comply with R432-100-21.

R432-500-22.  Medical Records.
	(1)  Direction.
	Medical records shall be complete, accurately documented, and systematically organized to facilitate storage and retrieval for staff use.  There shall be written policies and procedures to accomplish these purposes.
	(2)  Medical Record Organization.
	(a)  A permanent individual medical record shall be maintained for each patient admitted.
	(b)  All entries shall be permanent (typed or handwritten legibly in ink) and capable of being photocopied. Stamps are not acceptable unless a co-signature is present.  Entries must be authenticated including date, name or identified initials, and title of the person making the entry.
	(c)  Records shall be kept current and shall conform to good medical and professional practice based on the service provided to the patient.  Automated Record Systems may be utilized provided the medical record content maintained meets the requirements as defined within these rules.
	(d)  All records of discharged patients shall be completed and filed within a time frame established by facility policy.  The physician has the responsibility to complete the medical record.
	(3)  Medical Record Content.
	Each patient's medical record shall include the following:
	(a)  An admission record (face sheet) that includes the name, address, and telephone number of the patient, physician and responsible person and the patient's age and date of admission;
	(b)  A current physical examination and history, including allergies and abnormal drug reactions;
	(c)  Informed consent signed by the patient or, if applicable, the patient's representative;
	(d)  Complete findings and techniques of the operation;
	(e)  Signed and dated physician orders for drugs and treatments;
	(f)  Signed and dated nurse's notes regarding care of the patient.  Nursing notes shall include vital signs, medications, treatments and other pertinent information;
	(g)  Discharge summary which contains a brief narrative of conditions and diagnoses of the patient's final disposition, to include instructions given to the patient and responsible person;
	(h)  The pathologist's report of human tissue removed during the surgical procedure, if any;
	(i)  Reports of laboratory and x-ray procedures performed, consultations and any other pre-operative diagnostic studies;
	(j)  Pre-anesthesia evaluation.
	(4)  Retention and Storage.
	(a)  Medical records shall be retained for at least seven years after the last date of patient care.  Records of minors shall be retained until the minor reaches age 18 or the age of majority plus an additional three years.
	(b)  All patient records shall be retained by the new owners upon change of ownership.
	(c)  Provision shall be made for filing, safe storage, security, and easy accessibility of medical records.
	(5)  Release of Information.
	(a)  Medical record information shall be confidential.
	(i)  There shall be written procedures for the use and removal of medical records and the release of patient information.
	(ii)  Information may be disclosed only to authorized persons in accordance with federal and state laws, and facility policy.
	(iii)  Requests for information identifying the patient (including photographs) shall require written consent by the patient.
	(b)  Authorized representatives of the Department may review records to determine compliance with licensure rules and standards.

R432-500-23.  Housekeeping Services.
	(1)  Organization.
	There shall be housekeeping services to maintain a clean, sanitary, and healthful environment.  If the facility contracts for housekeeping services with an outside agency, there shall be a signed, dated agreement that details all services provided.  The housekeeping service shall meet all the requirements of this section.
	(2)  Policies and Procedures.
	Written housekeeping policies and procedures shall be developed and implemented by the facility, and reviewed and updated annually.
	(3)  Personnel.
	A sufficient number of housekeeping staff shall be employed to maintain both the exterior and interior of the facility in a safe, clean, orderly manner.
	(4)  Equipment and Supplies.
	(a)  Housekeeping equipment shall be suitable for institutional use and properly maintained.
	(b)  Cleaning solutions for floors shall be prepared according to manufacturer's instructions and be checked periodically to insure proper germicidal concentrations are maintained.
	(c)  There shall be sufficient numbers of noncombustible trash containers.  Lids shall be provided where appropriate.
	(d)  Storage areas containing cleaning agents, bleaches, insecticides, or poisonous, dangerous, or flammable materials, shall be safeguarded.  Toilet rooms shall not be used for storage.
	(e)  Throw or scatter rugs shall not be used in the main traffic areas of the facility or in exitways.

R432-500-24.  Laundry Services.
	(1)  Direction.
	(a)  Each facility shall have provisions for storage and processing of clean and soiled linen as required for patient care.
	(i)  Processing may be done within the facility, in a separate building (on or off site), or in a commercial or shared laundry.
	(ii)  If the facility contracts for laundry service, there shall be a signed, dated agreement that details all services provided.
	(iii)  The laundry service shall meet all requirements of this section.
	(b)  If the facility processes laundry on the premises, a qualified person shall be employed to direct the facility's laundry service.  The person shall have experience or training in the following:
	(i)  Proper use of the chemicals in the laundry;
	(ii)  Proper laundry procedures;
	(iii)  Proper use of laundry equipment;
	(iv)  Appropriate facility policy and procedures;
	(v)  Appropriate federal regulations, state rules, and local laws.
	(2)  Physical Plant.
	(a)  If laundry is processed by a commercial laundry which is not part of the facility, the facility must provide at least the following:
	(i)  A separate room, vented to the outside, for holding and sorting soiled linen until ready for transport;
	(ii)  A central, clean linen storage area in addition to the linen storage provided in each unit.  The central storage capacity shall be sufficient for the facility's operation;
	(iii)  A separate storage area to maintain clean and soiled linen carts out of traffic areas;
	(iv)  Handwashing facilities shall be provided in each area where unbagged soiled linen is handled.
	(b)  If laundry is processed by the facility (within or in a separate building), provision shall be made for the following:
	(i)  Receiving, holding and sorting room for control and distribution of soiled linen.  Soiled linen chutes may empty into this room;
	(ii)  A laundry room with washing machines adequate for the quantity and type of laundry to be processed;
	(iii)  A laundry room with dryers adequate for the quantity and type of laundry to be processed;
	(iv)  A clean storage room with space and shelving adequate to store one half of all laundry being processed;
	(v)  Convenient access to employee lockers and lounge;
	(vi)  Storage for laundry supplies;
	(vii)  Storage area to park clean and soiled linen carts out of traffic;
	(viii)  Traffic pattern through laundry area shall be:
	(A)  From building corridor to receiving and sorting/soiled linen room;
	(B)  From sorting soiled linen room to wash room;
	(C)  From wash room to dry room.  The dry room shall be separated from the wash room by a wall with a door;
	(D)  From dry room to clean storage or building corridor (covered and protected);
	(E)  Air flow shall be positive in direction; from clean to soiled, to exterior.
	(3)  Policies and Procedures.
	Each facility shall develop and implement policies and procedures relevant to operation of the laundry.  These policies and procedures shall be reviewed and updated annually, and shall address the following:
	(a)  Methods to handle, store, transport and process clean, soiled, contaminated, and wet linens;
	(b)  Water temperature to wash laundry that is at least 150 degrees F (66 degrees C) unless the laundry equipment manufacturer recommends other temperatures.  An automatic chemical sterilizing system may be used in lieu of 150 degrees F water with Department approval;
	(c)  Collection and transportation of soiled linen to the laundry in closed, leak-proof laundry bags or covered impermeable containers.  Separate linen carts labeled "SOILED" or "CLEAN LINEN" shall be constructed of washable material and shall be laundered or suitably cleaned to maintain sanitation;
	(d)  The training of laundry personnel in proper procedures for laundry infection control;
	(e)  Provision for adequate laundry equipment (washers, dryers, linen carts, transport carts) to maintain clean laundry for the facility;
	(f)  Maintenance of laundry equipment in proper working condition;
	(g)  Provision for a lavatory with hot and cold running water, soap and sanitary towels within the laundry area.
	(4)  Clean Linen.
	(a)  Clean linen shall be stored, handled, and transported in a manner to prevent contamination.  Clean linen shall be stored in clean closets, rooms, or alcoves used only for that purpose.
	(b)  Clean linen must be covered if stored in alcoves or transported through the facility.  Clean linen from a commercial laundry shall be delivered to a designated clean area in a manner that prevents contamination.
	(c)  Linens shall be maintained in good repair.  A supply of clean linen and other supplies shall be provided and available to staff to meet the needs of patients.
	(5)  Soiled Linen.
	(a)  Soiled linen shall be handled, stored and processed to prevent the spread of infections.  Soiled linen shall be sorted by methods to protect from contamination, and as specified in facility policy.
	(b)  Soiled linen shall be stored and transported in a closed container which prevents airborne contamination of corridors and areas occupied by patients, and precludes cross contamination of clean linens.  Laundry chutes shall be maintained in a clean sanitary condition.

R432-500-25.  Maintenance, Physical Environment, and Safety.
	Surgical centers shall provide a safe and sanitary environment.  All ambulatory surgical facilities shall comply with this Section.
	(1)  Direction.
	(a)  The administrator shall employ a person qualified by experience and training to be in charge of facility maintenance, or if the facility contracts for maintenance services, there shall be a signed, dated agreement that specifies agreement to comply with all requirements of this section.
	(b)  The facility shall develop and implement a written maintenance program (including preventive maintenance) to ensure continued equipment function and sanitary practices throughout the facility.
	(2)  Policies and Procedures.
	(a)  Each facility shall develop and implement maintenance, safety, and sanitation policies and procedures that shall be reviewed and updated annually.
	(b)  When maintenance is performed by an equipment-service company, the company shall certify that work performed, is in accordance with acceptable standards.  This certification shall be retained by the facility for review.
	(c)  A pest control program shall be developed to ensure the facility is free from vermin and rodents which shall be conducted in the facility buildings and grounds by a licensed pest control contractor or an employee trained in pest control procedures.  All openings to the outside of the facility shall prevent the entrance of insects and vermin.
	(d)  Architectural and engineering drawing, specification books, and maintenance literature concerning the design and construction of built-in systems should be available for use by maintenance and safety personnel.
	(e)  Instructional information, cautions, specifications, and operational data on all facility equipment shall be available for reference by all concerned departments.
	(f)  Systems-disconnects location information shall be readily available.
	(g)  Documentation shall be maintained for Department review of the pest control program and other maintenance activity.

R432-500-26.  General Maintenance.
	(1)  Equipment used in the facility shall be approved by Underwriter's Laboratory and meet all applicable Utah Occupational Safety and Health Act requirements in effect at the time of purchase.
	(2)  Draperies, carpets, and furniture shall be maintained clean and in good repair.
	(3)  Electrical systems including appliances, cords, equipment, call systems, switches, and grounding systems shall be maintained to assure safe functioning.
	(4)  Heating and cooling systems shall be inspected and documented annually to assure safe operation.  Written records of maintenance on high intensity (90%) filters and humidifiers shall be kept.
	(a)  Heating equipment shall be capable to maintain 80  degrees F.
	(b)  Cooling equipment shall be capable to maintain 74 degrees F.
	(5)  Electric circuits shall be tested annually to show that phase, voltage, amperage, grounding and load balancing are as required.
	(6)  Grounding systems in operating rooms shall be tested monthly and documented.
	(7)  Medical gas systems shall be inspected quarterly.
	(8)  Steam systems driving autoclaves and other sterilization equipment shall be tested regularly to assure proper operating temperatures, volumes, and pressures.  Gauges shall be tested annually.
	(9)  All switch-over devices, relays, breakers, outlets, and receptacles in the emergency system shall be tested quarterly.
	(10)  Air supplies, main burners and stack afterburners shall be inspected annually.
	(11)  All new equipment shall be tested prior to use.
	(12)  All patient care equipment shall be tested as specified in facility policy but at least according to manufacturer's specifications.
	(13)  All other electric and electronic equipment shall be tested at least annually.
	(14)  All testing and inspections of systems and equipment shall be done by qualified persons.
	(15)  Records shall be maintained of all inspections and testing.
	(16)  Maintenance work performed shall be documented.  All required records including maintenance, safety inspections, and drill schedules shall be retained for two years or from the date of the last major inspection.
	(17)  All buildings, fixtures, equipment, spaces, and sanitation systems shall be maintained in operable condition.
	(18)  Any chemical of a poisonous nature shall be properly labeled and shall not be stored with patient care items.

R432-500-27.  Air Filters.
	All air filters installed in heating, air conditioning, and ventilation systems, shall be inspected and filters replaced as needed to maintain the systems in operating condition.

R432-500-28.  Emergency Electric Service.
	(1)  The facility shall make provision for an emergency generator to provide power to critical areas essential for patient safety in the event of an interruption in normal electrical power service.
	(2)  There shall be provision for emergency exit lighting in accordance with NFPA 101.
	(3)  Flash lights shall be available for emergency use by staff.
	(4)  Testing Emergency Power Systems.
	(a)  All emergency electrical power systems shall be maintained in operating condition and tested as follows:
	(i)  The emergency power generator shall be tested weekly and run under load for a period of 30 minutes monthly.
	(ii)  Transfer switches and battery operated equipment shall be tested at approximately 14-day intervals.
	(b)  A written record of inspection, performance, test period, and repair of the emergency generator shall be maintained on the premises for review.

R432-500-29.  Storage and Disposal of Garbage, Refuse, and Waste.
	Facilities and equipment shall be provided for the sanitary storage and treatment or disposal of all categories of waste, including hazardous and infectious wastes if applicable, using techniques acceptable to the Department of Environmental Quality, and the local health department having jurisdiction.

R432-500-30.  Provisions for Gas Usage.
	(1)  Flammable anesthetic agents or chemicals may not be used unless the building is properly constructed for its use in accordance with NFPA guidelines.
	(a)  Compressed gases and flammable liquids shall be stored safely.  All compressed gas cylinders in storage shall be capped and secured.  Oxidizing agents may not be stored with flammables.
	(b)  Oxygen and flammable agents shall be stored away from combustibles.  Liquid flammable agents shall be stored in metal cabinets with no more than ten gallons of any one flammable liquid or 60 gallons total of flammable liquids stored per cabinet.  Warning signs shall be posted when compressed gases or flammable liquids are used.
	(2)  Equipment shall be available to extinguish liquid oxygen and enriched gases.  Employees shall be trained in the proper use of equipment and containment of combustions.
	(3)  When using oxygen, provision shall be made for at least the following:
	(a)  Safe handling and storage;
	(b)  Facility personnel shall not transfer gas from one cylinder to another;
	(c)  Piped oxygen system shall be tested in accordance with The NFPA 56F and 56K and a written report shall be filed as follows:
	(i)  Upon completion of initial installation;
	(ii)  Whenever changes are made to the system;
	(iii)  Whenever the integrity of the system has been breached;
	(iv)  There shall be a scavenging system for evacuation of anesthetic waste gas.

R432-500-31.  Lighting.
	(1)  Sodium and mercury vapor lights shall not be used inside the facility, but may be used as a source of exterior lighting.
	(2)  All accessible storeroom, stairway, ramp, exit and entrance areas shall be illuminated by at least of 20 foot-candles of light at floor level.
	(3)  All corridors shall be illuminated with a minimum of 20 foot-candles of light at floor level.
	(4)  Other areas shall be provided with the following minimum foot candles of light at working surfaces:
	(a)  Operating rooms : 50 Foot-candles
	(b)  Medication preparation areas : 50 foot-candles
	(c)  Charting areas : 50 foot-candles
	(d)  Reading areas : 50 foot-candles
	(e)  Laundry areas : 30 foot-candles
	(f)  Toilet, bath, and shower rooms : 30 foot-candles
	(g)  Nutritional area : 30 foot-candles.

R432-500-32.  Water Supply.
	(1)  Plumbing and drainage facilities shall be maintained in compliance with Utah Plumbing Code.
	(2)  Backflow prevention devices shall be maintained in operating condition and tested when required by the Utah Plumbing Code and Utah Public Drinking Water Regulations.
	(3)  Hot water temperature controls shall automatically regulate temperatures of hot water delivered to plumbing fixtures used by staff and patrons.  The facility shall maintain hot water delivered to patient care areas at temperatures between 105 and 115 degrees F.  Temperatures shall be regularly tested and a record maintained as part of the preventive maintenance program.
	(4)  There shall be grab bars at each bathroom facility used by patients.
	(5)  Water sterilizers, exchangers, distilleries, deionizers and filters shall be functional and shall provide the quality of water intended in each application.

R432-500-33.  Sanitation Facilities.
	(1)  Handwashing and toilet facilities shall be adequate in number and convenient for use by employees and patrons.  Facilities shall be kept clean, in good repair and adequately ventilated.
	(2)  An adequate supply of hand cleansing soap and a supply of sanitary towels or approved hand drying appliance shall be available for use.  Common towels are prohibited.
	(3)  Adequate and conveniently located toilet facilities shall be provided for employees and patrons.  Toilet facilities shall be kept clean, in good repair, and free of objectionable odors.  They shall be adequately ventilated.
	(4)  All toilet and bathroom doors used by patients and opening inward into the bath or toilet room shall also allow the door to be removed from the outside of the bath or toilet room.
	(5)  Other Safety and Sanitation Provisions.
	(a)  Trash chutes, laundry chutes, and dumb waiters shall be safe and sanitary.  Trash and laundry chutes, elevators, dumb waiters, message tubes, and other such systems shall not pump contaminated air into clean areas.
	(b)  The use of exposed element portable heaters is prohibited.
	(c)  If virulent agents are tested in the facility, a shielded exhaust hood or other equivalent protective device(s) shall be provided.
	(d)  Building, grounds, walkways, and parking shall be free of hazards and in good repair.  Parking and walkways shall be clear of snow and ice.  A clear unobstructed path shall be maintained from all emergency exits to a public way.
	(e)  Floors shall be maintained so they are in good repair.  Floors in labs, toilet rooms, baths, kitchens, and isolation rooms shall be of ceramic tile, roll-type vinyls, or seamless bonded flooring which is resilient, non-absorbent, impervious, and easily cleaned.
	(f)  Traffic in all patient care areas shall be monitored.  Only authorized individuals shall have access to sterile areas.

R432-500-34.  Penalties.
	Any person who violates any provision of this rule may be subject to the penalties enumerated in 26-21-11 and R432-3-6 and be punished for violation of a class A misdemeanor as provided in 26-21-16.

KEY:  health care facilities
Date of Enactment or Last Substantive Amendment:  October 1, 2011
Notice of Continuation:  November 9, 2015
Authorizing, and Implemented or Interpreted Law:  26-21-5; 26-21-16