North Carolina Administrative Code

10A NCAC 13B .4507 STORAGE (a) All drugs and related pharmaceutical supplies located throughout the facility shall be under the control of the pharmacy service. (b) All areas where drugs and related pharmaceutical supplies are stored shall be monitored at least monthly by the pha…

10A NCAC 13B .4508 RESERVED FOR FUTURE CODIFICATION

10A NCAC 13B .4509 SECURITY (a) The director of pharmacy shall require that all drugs and related pharmaceutical supplies be stored in a lockable environment except when under the direct supervision of personnel authorized by the pharmacy committee to handle drugs. (b) Controlled…

10A NCAC 13B .4510 RECORDS (a) The director of pharmacy shall provide that all drug transactions of the pharmacy shall be recorded as described in policies approved by the pharmacy committee. (b) The director of pharmacy shall establish and maintain a system of records and bookke…

10A NCAC 13B .4511 MEDICATION ADMINISTRATION (a) A facility shall establish and maintain policies and procedures governing the administration of medications which shall be enforced and implemented by administration and staff. Policies and procedures shall include: (1) accountabil…

10A NCAC 13B .4512 MEDICATIONS DISPENSED (a) Except as provided in Paragraph (c) of this Rule, the pharmacy shall dispense only those drugs which are listed in one or more of the references listed in Paragraph (b) of this Rule. No drug which is listed in Paragraph (b) of this Rul…

10A NCAC 13B .4513 DRUG DISTRIBUTION SYSTEMS (a) The pharmacy committee shall develop written policies and procedures pertaining to the intra-facility drug distribution system. In developing such policies the committee shall utilize representatives of other disciplines within the…

10A NCAC 13B .4514 EMERGENCY PHARMACEUTICAL SERVICES The director of pharmacy shall be responsible for emergency pharmaceutical services as currently described in the Pharmacy Laws of North Carolina. History Note: Authority G.S. 131E-79; Eff. January 1, 1996; Pursuant to G.S. 150…

10A NCAC 13B .4515 DISPOSITION Drugs, and pharmaceutical devices which are outdated, visibly deteriorated, unlabeled, inadequately labeled, recalled, discontinued or obsolete shall be identified by a pharmacist and shall be disposed of in compliance with applicable state and fede…

10A NCAC 13B .4516 COMMERCIAL PHARMACEUTICAL SERVICE A facility using an outside pharmacist or pharmaceutical service must have a contract with that pharmacist or service. As part of the contract, the pharmacist or service shall be required to maintain at least the standards for …

SECTION .4600 - SURGICAL AND ANESTHESIA SERVICES 10A NCAC 13B .4601 ORGANIZATION (a) The governing body shall approve the types of surgery and types of anesthesia services to be available throughout the hospital consistent with identified needs and resources. (b) The facility sha…

10A NCAC 13B .4602 DIRECTOR OF SURGICAL SERVICES (a) Each department or service providing surgical services shall be directed by members of the medical staff whose clinical and administrative privileges have been approved by the governing body. (b) The medical staff shall establi…

10A NCAC 13B .4603 SURGICAL AND ANESTHESIA STAFF The facility shall develop processes that require each individual provide only those services for which proof of licensure and competency can be demonstrated. The facility shall require that: (1) when anesthesia is administered, a …

10A NCAC 13B .4604 DIRECTION OF ANESTHESIA SERVICES (a) The facility shall be organized, directed and integrated with other related services or departments of the facility. (b) The department of anesthesia shall require that all anesthetics are administered according to procedure…

10A NCAC 13B .4605 POLICIES AND PROCEDURES (a) The director of surgical services shall develop policies and procedures for surgical and anesthesia services which shall be available to the medical, surgical, anesthesia staff and nursing personnel. (b) The facility shall require th…

SECTION .4700 - NUTRITION AND DIETETIC SERVICES 10A NCAC 13B .4701 PROVISION OF SERVICES The nutrition and dietetic services shall be organized, directed, staffed and integrated with other facility departments to provide optimal nutritional therapy and quality food service to pat…

10A NCAC 13B .4702 ORGANIZATION (a) The nutrition and dietetic services shall be under the full-time direction of a person who is trained or experienced in food services administration and therapeutic diets. The director shall be one of the following: (1) A qualified dietitian; (…

10A NCAC 13B .4703 SANITATION AND SAFETY (a) The nutrition and dietetic service shall comply with current laws and rules for sanitation as promulgated by the Commission for Public Health, including but not limited to 15A NCAC 18A .1300. Copies of 15A NCAC 18A .1300 may be obtaine…

10A NCAC 13B .4704 DISTRIBUTION OF FOOD (a) Food shall be transported and displayed pursuant to the rules adopted by the Commission for Public Health. (b) At the time of serving, the temperature of hot foods shall be no less than: (1) Hot liquids - 150 degrees Fahrenheit (minimum…

10A NCAC 13B .4705 NUTRITIONAL SUPPORT (a) The administration of the nutritional support shall be directed by a qualified dietitian. Observations and information pertinent to nutrition therapy shall be documented in the medical record of the patient. (b) The facility shall have a…

SECTION .4800 - DIAGNOSTIC IMAGING 10A NCAC 13B .4801 ORGANIZATION (a) Imaging services shall be under the supervision of a full-time radiologist, consulting radiologist, or a physician. (b) Radio-therapy is a type of imaging service. (c) All imaging equipment shall be operated u…

10A NCAC 13B .4802 RECORDS (a) A documented record on each imaging examination shall be included in the patient's medical record. (b) Imaging reports shall be signed by the physician interpreting the study. (c) Copies of current reports made by private physicists or governing aut…

10A NCAC 13B .4803 STAFFING (a) The staffing of the imaging department shall be determined by the radiologist in charge or by another person designated by hospital management. (b) There shall be a minimum of one radiologic technologist available to the department on at least an o…

10A NCAC 13B .4804 MONITORING RADIATION EXPOSURE OF PERSONNEL (a) The facility shall establish procedures for the monitoring of personnel and shall maintain a record for each individual working in the area of radiation where there is a reasonable probability of receiving one-four…

10A NCAC 13B .4805 SAFETY (a) The facility shall require that all imaging equipment is operated under the supervision of a physician and by qualified personnel. (b) The facility shall require that caution is exercised to protect all persons from exposure to radiation. (c) The gov…

10A NCAC 13B .4806 NUCLEAR MEDICINE SERVICES When nuclear medicine services are offered, the facility shall establish and maintain written policies and procedures for the provision of those services which shall provide for the safety of patients and staff, management of radioacti…

SECTION .4900 - LABORATORY SERVICES AND PATHOLOGY 10A NCAC 13B .4901 ORGANIZATION The laboratory shall be under the supervision of a clinical pathologist, or a physician who has training in clinical laboratory diagnosis designated by the governing body. History Note: Authority G.…

10A NCAC 13B .4902 RECORDS (a) All requests for laboratory services shall be documented. (b) All reports of laboratory services performed, including autopsy, shall be placed in the patient's medical record. (c) Records of proficiency testing appropriate to the scope of services o…

10A NCAC 13B .4903 STAFFING The laboratory supervisor or his appointed designee, shall require that: (1) procedures and tests conducted are within the scope of the laboratory as approved by the hospital; (2) at least one qualified medical technologist is available at all times; a…

10A NCAC 13B .4904 TESTS (a) Laboratory tests to be performed on a patient at the time of admission (if any) shall be established by the medical staff and be approved by the governing board of the hospital. In the event the medical staff and governing body elect not to establish …

10A NCAC 13B .4905 TISSUE REMOVAL AND DISPOSAL (a) The medical staff shall establish and maintain written policies for pathological examination of tissue and specimens removed during surgery. (b) Pathological waste disposal shall comply with the rules Governing the Sanitation of …

10A NCAC 13B .4906 BLOOD BANK (a) Facilities which provide for procurement, storage and transfusion of blood shall meet the standards of the American Association of Blood Banks as outlined in the most current edition of Standards of Blood Banks and Transfusion Services, which is …

10A NCAC 13B .4907 MORGUE AND AUTOPSY FACILITIES (a) Morgue and autopsy services shall be provided either on site or by written agreement with a facility that provides those services. (b) Procedures for the transport and storage of deceased patients shall be established and maint…

SECTION .5000 - PHYSICAL REHABILITATION SERVICES 10A NCAC 13B .5001 ORGANIZATION The facility shall designate an individual responsible for the administration and supervision of each rehabilitation service. History Note: Authority G.S. 131E-79; Eff. January 1, 1996; Pursuant to G…

10A NCAC 13B .5002 DELIVERY OF CARE (a) A member of the medical staff shall be responsible for the general medical care of the inpatient. (b) The delivery of all rehabilitation services shall be provided by practitioners credentialed or licensed in their respective fields. Histor…

10A NCAC 13B .5003 POLICIES AND PROCEDURES The facility shall establish and maintain written policies and procedures that include but are not limited to: (1) provision for assessment and evaluation of the services performed; (2) safety measures; (3) infection control measures; an…

10A NCAC 13B .5004 PATIENT RECORDS The patient record shall contain documentation of physical rehabilitation services utilized that include but is not limited to: (1) diagnosis to support the services requested; (2) assessment of patient's rehabilitative status; (3) re-assessment…

10A NCAC 13B .5005 CARDIAC REHABILITATION PROGRAM When a facility elects to provide an outpatient cardiac rehabilitation program, the program shall be subject to 10 NCAC 3S, Sections .0300 - .1000, which are incorporated by reference with all subsequent amendments. Referenced rul…

SECTION .5100 - INFECTION CONTROL 10A NCAC 13B .5101 ORGANIZATION (a) The governing body shall establish and maintain an infection control program that includes all patient care and patient care support services and departments for the surveillance, prevention and control of infe…

10A NCAC 13B .5102 POLICY AND PROCEDURES (a) Each facility department or service shall establish and maintain the following written infection control policies and procedures: (1) the role and scope of the service or department in the infection control program; (2) the role and sc…

10A NCAC 13B .5103 LAUNDRY SERVICE The facility shall provide, directly or by contract, a laundry service or department that provides the following: (1) 24 hour a day availability of clean linen for patient care needs; and (2) delivery of clean linen and removal of soiled linen i…

10A NCAC 13B .5104 ENVIRONMENTAL SERVICES The facility shall require that environmental services (housekeeping) provide the following: (1) 24 hour a day availability of personnel or supplies and equipment for the cleaning of patient rooms, patient care equipment, and the cleaning…

10A NCAC 13B .5105 STERILE SUPPLY SERVICES The facility shall provide for the following: (1) decontamination and sterilization of equipment and supplies; (2) monitoring of sterilizing equipment on a routine schedule; (3) establishment of policies and procedures for the use of dis…

SECTION .5200 - PSYCHIATRIC SERVICES 10A NCAC 13B .5201 PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES: APPLICABILITY OF RULES The rules contained in this Section shall apply to all psychiatric and substance abuse services provided by any facility. History Note: Authority G.S. 131E-79; …

10A NCAC 13B .5202 DEFINITIONS APPLICABLE TO PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES (a) "Certified counselor" means an alcoholism, drug abuse or substance abuse counselor who is certified by the North Carolina Substance Abuse Professional Certification Board. (b) "Certified subs…

10A NCAC 13B .5203 STAFFING FOR PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES (a) General Requirements: (1) A physician shall be present in the facility or on call 24 hours per day. The medical appraisal and medical treatment of each patient shall be the responsibility of a physician; …

10A NCAC 13B .5204 PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES RECORD REQUIREMENTS (a) In addition to the general record keeping requirements of 10A NCAC 13B .3906, specialized assessment and treatment plans for individuals undergoing psychiatric or substance abuse treatment are as f…