Drug distribution

(a) General. The EH shall provide routine and emergency drugs and biologicals in a safe and accurate manner to meet the needs of the patients. The EH may provide all drug distribution services directly with a complete licensed hospital pharmacy or drug room, or services may be provided by contract with a licensed pharmacy. The medical and professional staff and the EH pharmacist shall be responsible for oversight of drug distribution services and shall approve policies and procedures that ensure compliance with state and federal laws and minimize drug errors. If required, the EH shall annually register with the Oklahoma State Board of Pharmacy. (b) Personnel. (1) The drug distribution service shall be directed by a pharmacist OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 99 September 13, 2019 on a full-time, part-time, or consultant basis. The pharmacist shall be responsible for developing, supervising, and coordinating all activities of drug distribution in the EH. The responsibility and authority of the pharmacist shall be clearly defined in a written job description. All compounding, packaging, labeling and dispensing of drugs and biologicals shall be performed or directly supervised by the pharmacist. (2) If the EH only maintains a drug room, drugs and biologicals shall be distributed and administered only to patients of the EH. The pharmacist director shall be available at least as a consultant and a registered or licensed practical nurse shall be designated in writing as the drug room supervisor to ensure drugs and biologicals are properly distributed and stored. The drug room supervisor may have other job responsibilities in the EH as long as drug distribution services are adequately maintained. (c) Delivery of services. (1) Drugs and biologicals shall be kept in a locked storage area and distributed in accordance with applicable standards of practice, consistent with state and federal laws. Outdated, mislabeled, or otherwise unusable drugs and biologicals shall not be maintained available for patient use. Storage of drugs and biologicals shall be in accordance with the manufacturer's instructions. (2) Records shall be maintained of the transactions of the pharmacy or drug room to account for the receipt, distribution, disposition and destruction of all drugs and biologicals. (3) A record of the stock of controlled dangerous drug substances on hand shall be maintained in a manner so that the disposition of any particular item may be readily traced. All Schedule II drugs shall be maintained as specified in OAC 310:667-21-8(c). (4) All drugs and biologicals shall be provided to patients only upon written order of a physician or practitioner authorized by law to write a prescription, with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment for contraindications. The prescriber's original order or a copy shall be available to the pharmacy or drug room prior to distributing or dispensing the drug or biological. The order may be electronically transmitted. Methods shall be provided to ensure the reconciliation of all drugs distributed for patient administration. (5) Access to the pharmacy or drug room shall be restricted to authorized individuals when the pharmacist or drug room supervisor is unavailable. The EH shall establish written procedures which permit authorized individuals access, establish methods of maintaining drug inventory and control, and require record keeping of drugs removed. (6) Floor stock medications shall be controlled and maintained to limit after hours access to the pharmacy or drug room. Distribution shall be in accordance with a floor stock drug list which shall be established for each floor stock area. A method shall be provided for reconciliation of floor stock drugs distributed for use in a procedure or for a particular patient. The pharmacist shall check all floor stock medication areas at least monthly to ensure records are accurate and stock continues to be suitable for use. (7) Drugs and biologicals not specifically prescribed as to length OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 100 September 13, 2019 of time or number of doses shall be automatically stopped after a reasonable time established by the medical and professional staff. (8) Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician or licensed independent practitioner. As appropriate, reports of errors and adverse reactions shall be made to the EH quality assurance committee. (9) Abuse and loss of controlled substances shall be immediately reported to the pharmacist director and to the administrator who shall make required reports to local, state and federal authorities. If the EH maintains a pharmacy or drug room, the administrator, or the administrator's authorized representative, shall inventory pharmacy controlled substances and alcohol at least annually. (10) Information relating to drug interactions, drug therapy, side effects, toxicology, dosage, indications for use, routes of administration and poison control shall be made available by the pharmacist director to nursing service and the medical and professional staff. (11) Drugs and biologicals maintained by the EH shall be based on a formulary established by the medical and professional staff. (d) Physical facilities. The EH shall maintain, as appropriate, adequate facilities to ensure drugs and biologicals are safely compounded, packaged, dispensed and stored as required. Equipment and supplies shall be provided to adequately protect personnel from toxic substances and to ensure the integrity of any medication or parenteral solution. 310:667-40-13. Diagnostic services (a) Radiological services. The EH shall maintain or have available diagnostic radiological services according to the needs of the patients. (1) Radiological services shall be free from hazards for patients and personnel. Proper safety precautions shall be maintained against fire and explosion hazards, electrical hazards, and radiation hazards. (2) Diagnostic x-ray equipment shall have a current permit issued by the Department and shall be inspected at least every two (2) years by a certified health physicist or by Department staff. Any identified hazards shall be promptly corrected. (3) The hospital shall identify those employees who are subject to significant occupational exposure to radiation while performing their job duties. All such workers shall be checked periodically for amounts of radiation exposure by the use of exposure meters or badge tests. (4) The EH shall have a qualified radiologist available on a full- time, part-time or consulting basis both to supervise services and interpret diagnostic images that require specialized knowledge for accurate reading. Diagnostic images may be electronically transmitted or delivered off-site for interpretation by the radiologist. The interpretation of radiological examinations shall be made by physicians or licensed independent practitioners competent in the field according to individually granted clinical privileges. OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 101 September 13, 2019 Reports of interpretations shall be written or dictated and signed by the radiologist, physician, or licensed independent practitioner making the interpretation. All diagnostic image interpretations shall be incorporated into the patient's medical record with a duplicate copy kept with the image. (5) The use of diagnostic x-ray equipment shall be limited to personnel designated as qualified by the radiologist and the medical and professional staff. Fluoroscopic procedures may be performed by radiology technologists only upon the written authorization of a qualified radiologist, and in the presence of a physician or licensed independent practitioner or by real time visualization through electronic means. (6) The EH shall maintain copies of reports and diagnostic images for at least five (5) years. (7) If the EH provides imaging services other than routine diagnostic x-ray, the EH shall comply with appropriate sections of OAC 310:667-23-2. (b) Laboratory services. (1) The EH shall have a well-organized, adequately supervised clinical laboratory with necessary staff, space, facilities, and equipment to perform those services commensurate with the needs of its patients. All or part of these services may be provided by arrangements with certified reference laboratories as long as services are available on an emergency basis twenty-four (24) hours a day. (2) If a EH directly provides laboratory services, it shall meet all conditions as set forth in 42 CFR part 493 and be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). The EH shall possess a current, unrevoked or unsuspended certificate appropriate for the extent of testing performed issued by the Department of Health and Human Services applicable to the category of examinations or procedures performed by the facility. (3) If an EH provides laboratory services under arrangement, the referral laboratory shall also meet the requirements of this section. Referral laboratories used by the EH shall have the ability to electronically transmit emergency test results. [Source: Added at 20 Ok Reg 1664, eff 6-12-2003] 310:667-40-14. Emergency services (a) General. The EH shall provide emergency stabilization and treatment services commensurate with emergency medical needs of the community and EH service area. All services shall be provided in accordance with acceptable standards of practice, compliant with applicable state and federal laws. (b) Organization and direction. The service shall be directed by personnel deemed qualified by the governing body and integrated with the nursing stabilization and observation unit of the EH. (1) Services shall be organized under the direction of a qualified member of the medical and professional staff. Nursing functions shall be the responsibility of a registered nurse and shall be supervised by the director of nursing. OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 102 September 13, 2019 (2) There shall be written policies and procedures that establish protocols for emergency services provided. Policies shall also include written procedures for stabilization and transfer of patients whose treatment needs cannot be met at the EH. EH emergency service policies shall include protocols for emergency deliveries if the patient cannot be safely transferred. (c) Facilities, medications, equipment and supplies. Facilities, medications, equipment and supplies shall be provided to ensure prompt initial diagnosis and emergency medical treatment. (1) The emergency services area shall be in close proximity to an exterior entrance of the EH. (2) Medications commonly used in life-saving procedures shall be provided. These shall include but not be limited to the following drugs and biologicals: analgesics, local anesthetics, antibiotics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensives, diuretics, electrolytes, plasma expanders and replacement solutions. (3) Equipment and supplies commonly used in life-saving procedures shall be provided. These shall include but not be limited to: airways, endotracheal tubes, laryngoscope, ambu bag/valve/mask, obstetrics pack, tracheostomy set, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. (4) The emergency service shall be equipped with a base station radio using medical frequencies VHF 155.340 or UHF Medical Channels 1 through 10 and/or compatible frequencies with emergency medical services operating in the area. Direct communications between the emergency service and the on-call physician or licensed independent practitioner and the on-call or on-site registered nurse shall be established as specified at OAC 310:667-40-2(b). (d) Medical and nursing personnel. There shall be adequate medical and nursing personnel qualified in emergency care available at all times to meet the emergency service needs of the EH. (1) A physician or licensed independent practitioner shall be available at all times to directly communicate with EH staff providing emergency care. The physician or licensed independent practitioner shall be able to be physically present at the EH as specified by written facility policy. (2) A physician or licensed independent practitioner shall be on duty or on call at all times. This physician or practitioner shall be able to present at the EH in a period of time not to exceed twenty (20) minutes. (3) A registered nurse shall be available at all times to assess, evaluate, and supervise the nursing care provided. If the EH has no inpatients, the registered nurse may be available on an on-call basis if he or she can return to the EH in a period of time not to exceed twenty (20) minutes when a patient presents to the emergency service. All emergency medical patients shall be evaluated on-site by a registered nurse unless the patient is evaluated on-site by a physician or licensed independent practitioner. (4) Adequate support staff shall be available on-site to meet the emergency service needs of the EH. If the EH has no inpatients and OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 103 September 13, 2019 registered nursing services are provided on an on-call basis, the emergency service shall be staffed with at least an intermediate or paramedic level emergency medical technician. All EH staff providing emergency services shall have current CPR certification. (e) Emergency medical records. (1) Adequate medical records on every patient shall be kept. Each record shall contain the following as applicable: (A) Patient identification. (B) Time and means of injury. (C) History of disease or injury. (D) Physical findings. (E) Laboratory and x-ray reports, if any. (F) Diagnosis and therapeutic orders. (G) Record of treatment including vital signs. (H) Disposition of the case. (I) Signature of the registered nurse. (J) Signature of the physician or licensed independent practitioner, if applicable. (K) Documentation if the patient left against medical advice. (2) Medical records for patients treated by the emergency service shall be organized and where appropriate integrated with inpatient records. A method of filing (hard copy or electronic) shall be maintained which assures prompt retrieval. (f) Drug and biologicals distribution and control. Drugs and biologicals in the emergency service shall be securely maintained and controlled by staff at all times. If the service does not have staff present at all times, all drugs and biologicals shall be secured in sealed or locked storage with devices placed to denote tampering. All Schedule II drugs shall be stored as specified by OAC 310:667-21-8(c). All drugs and biologicals shall be administered and dispensed as required by state law. (g) Patient examinations, treatments and transfers. Patient examinations, treatments and transfers shall be conducted in accordance with 42 U.S.C. (1395dd) and 42 U.S.C. (1395cc) and with the regulations at 42 CFR part 489.20 and 489.24. [Source: Added at 20 Ok Reg 1664, eff 6-12-2003] 310:667-40-15. Outpatient services (a) General. The EH may provide limited outpatient services consistent with the diagnostic and treatment capabilities of the facility. These services may be provided in the emergency services area or in a separate examination or treatment room. (b) Personnel. There shall be adequate professional staffing to ensure personnel can effectively provide outpatient services while continuing to meet the needs of emergency patients. (1) A physician or licensed independent practitioner shall be responsible for the services provided to each patient. (2) The director of nursing shall be responsible for all nursing services provided. (3) Additional EH staff shall be available as necessary to provide required diagnostic and treatment services. (c) Medical records. Medical records shall be maintained and integrated OAC 310:667 OKLAHOMA STATE DEPARTMENT OF HEALTH 104 September 13, 2019 with the EH medical record system. Information contained in the medical record shall be complete and sufficiently detailed relative to the patient's history, physical examination, diagnosis, diagnostic procedures, medication administration, and treatment to facilitate continuity of care. [Source: Added at 20 Ok Reg 1664, eff 6-12-2003] 310:667-40-16. Therapy services (a) Respiratory therapy. If the EH provides respiratory therapy either directly or by contract, the services shall meet the requirements specified at OAC 310:667-23-5. (b) Physical and occupational therapy. If the EH provides physical and/or occupational therapy either directly or by contract, the services shall meet the requirements specified at OAC 310:667-23-6. [Source: Added at 20 Ok Reg 1664, eff 6-12-2003] SUBCHAPTER 41. GENERAL CONSTRUCTION PROVISIONS