North Carolina Administrative Code

10A NCAC 13B .3703 APPOINTMENT (a) The governing body may grant, deny, renew, modify, suspend, or terminate medical staff membership and clinical privileges after consideration of the recommendation made by the medical staff in accordance with the bylaws established by the medica…

10A NCAC 13B .3704 Establishment and categories of medical staff membership (a) The medical staff shall be established in accordance with the bylaws of the facility and organized in accordance with the bylaws, rules, and regulations of the medical staff. After considering the rec…

10A NCAC 13B .3705 MEDICAL STAFF BYLAWS, Rules, and REGULATIONS (a) The active medical staff shall develop and adopt, subject to the approval of the governing body, a set of bylaws, rules, and regulations to establish a framework for self-governance of medical staff activities an…

10A NCAC 13B .3706 ORGANIZATION AND RESPONSIBILITIES OF THE MEDICAL STAFF (a) The medical staff shall be organized to accomplish its required functions as established by the governing body and medical staff bylaws, rules, and regulations and provide for the election or appointmen…

10A NCAC 13B .3707 MEDICAL ORDERS (a) No medication or treatment shall be administered or discontinued except in response to the order of a member of the medical staff in accordance with policies, rules, and regulations established by the facility and medical staff and as provide…

10A NCAC 13B .3708 MEDICAL STAFF RESPONSIBILITIES FOR QUALITY IMPROVEMENT REVIEW (a) The medical staff shall have in effect a system to review care provided at the facility by members of the medical staff, to assess quality, to provide a process for quality improvement, and to mo…

SECTION .3800 - NURSING SERVICES 10A NCAC 13B .3801 NURSE EXECUTIVE (a) Whether the facility utilizes a centralized or decentralized organizational structure, a nurse executive shall be responsible for the coordination of nursing organizational functions. (b) A nurse executive sh…

10A NCAC 13B .3802 NURSING STAFF (a) Licensed nurses and other nursing personnel shall be qualified by training, education, experience and demonstrated abilities to provide nursing care within their scope of practice. (b) Staffing schedules which reflect personnel assignment by d…

10A NCAC 13B .3803 NURSING POLICIES AND PROCEDURES (a) Nursing policies and procedures shall be available to the nursing staff in each nursing care unit and service area and shall include the following: (1) method of noting diagnostic and therapeutic orders; (2) method of assigni…

10A NCAC 13B .3804 PATIENT CARE (a) Each patient's need for nursing care related to his or her admission shall be determined by a registered nurse. Patient needs shall be reassessed when warranted by the patient's condition. (b) Each patient's nursing care shall be based upon ass…

SECTION .3900 - MEDICAL RECORD SERVICES 10A NCAC 13B .3901 ORGANIZATION (a) The facility shall establish a medical record service. It shall be directed, staffed and equipped to accurately process, index, and file all medical records. Orientation, on-the-job training and inservice…

10A NCAC 13B .3902 MANAGER (a) The medical records service shall be directed and supervised by a qualified medical records manager. If the manager is not a registered record administrator or an accredited records technician, the facility shall retain a person with those qualifica…

10A NCAC 13B .3903 PRESERVATION OF MEDICAL RECORDS (a) The manager of the medical records service shall maintain medical records that were created when the patient was an adult, whether original, computer media, or digital archived for 11 years following the discharge of an adult…

10A NCAC 13B .3904 PATIENT ACCESS The manager of medical records shall provide patients or patient designees, when requested, access to or a copy of their medical records, or both. Upon the death of a patient, the executor of the decedent's estate, or in the absence of an executo…

10A NCAC 13B .3905 PATIENT MEDICAL RECORDS (a) Hospital management shall maintain medical records for each patient treated or examined in the facility. (b) The medical record or medical record system shall provide data for each episode of care and treatment rendered by the facili…

10A NCAC 13B .3906 CONTENTS (a) The medical record shall contain sufficient information to justify the diagnosis, verify the treatment and document the course of treatment and results accurately. (b) All in-patient records shall include the following information: (1) identificati…

10A NCAC 13B .3907 MEDICAL RECORDS REVIEW The medical staff shall review medical records periodically for completeness and shall: (1) establish requirements regarding completion of medical records, including a system for disciplinary actions for those who do not complete records …

SECTION .4000 - OUTPATIENT SERVICES 10A NCAC 13B .4001 ORGANIZATION (a) The facility shall establish and maintain outpatient care services in accordance with the facility's written mission statement. (b) The relationship of outpatient services to other divisions within the facili…

10A NCAC 13B .4002 STAFFING (a) The director of outpatient services shall require that ambulatory care services are staffed with sufficient personnel in accordance with a written plan. (b) The responsibility for the delivery of outpatient services by the professional staff shall …

10A NCAC 13B .4003 POLICIES AND PROCEDURES (a) The provision of outpatient services shall be guided by written policies and procedures which shall be developed by the facility and approved by the medical staff. The policies and procedures shall be reviewed by the medical staff at…

10A NCAC 13B .4004 OUTPATIENT SURGICAL AND ANESTHESIA SERVICES (a) When surgical or anesthesia services are provided in an outpatient setting, the facility shall require that the medical staff approve all types of surgical procedures to be offered. The facility shall maintain and…

10A NCAC 13B .4005 MEDICAL RECORDS (a) The manager of outpatient services shall require that a record of outpatient care and services for each patient is maintained either in the ambulatory care services or medical records department. (b) The facility shall develop a system of id…

SECTION .4100 - EMERGENCY SERVICES 10A NCAC 13B .4101 EMERGENCY RESPONSE CAPABILITY REQUIRED The medical staff of each facility shall require that facility personnel are capable of initiating life-saving measures at a first-aid level of response for any patient or person in need …

10A NCAC 13B .4102 CLASSIFICATION OF OPTIONAL EMERGENCY SERVICES (a) Any facility providing emergency services shall classify its capability in providing such services according to the following criteria: (1) Level I: (A) the facility shall have a comprehensive, 24-hour-per-day e…

10A NCAC 13B .4103 PROVISION OF EMERGENCY SERVICES (a) Any facility providing emergency services shall establish and maintain policies requiring medical screening, treatment and transfer services for any individual who presents to the facility emergency department and on whose be…

10A NCAC 13B .4104 MEDICAL DIRECTOR (a) The governing body shall establish the qualifications, duties, and authority of the director of emergency services. Appointments shall be recommended by the medical staff and approved by the governing body. (b) The medical staff credentials…

10A NCAC 13B .4105 NURSING (a) Level I and Level II emergency services shall have one or more registered nurses assigned and on duty within the emergency service area at all times. (b) A Level III emergency service shall have a registered nurse available on at least an on-call, i…

10A NCAC 13B .4106 POLICIES AND PROCEDURES Each emergency department shall establish written policies and procedures that specify the scope and conduct of patient care to be provided in the emergency areas. They shall include the following: (1) the location, storage, and procurem…

10A NCAC 13B .4107 EMERGENCY RECORDS (a) The facility shall require all levels of emergency departments to maintain a continuous control register on each patient seen for services which shall include at least the name, age, sex, date, time, and means of arrival, nature of complai…

10A NCAC 13B .4108 OBSERVATION BEDS When observation beds are used, the facility shall implement written policies and procedures that address the type of patient use, the mechanism for providing appropriate clinical monitoring, the length of time services may be provided in this …

10A NCAC 13B .4109 TRANSFER (a) The facility shall establish and implement protocols for stabilization and transportation of emergency patients. (b) A facility with specialized capabilities, such as burn units, shock-trauma units and neonatal intensive care units, shall not refus…

10A NCAC 13B .4110 DISASTER AND MASS CASUALTY PROGRAM (a) The facility shall describe: (1) the level of emergency services available during an external disaster; (2) the emergency department's role in the facility's external disaster plan; (3) procedures to be followed in the eve…

SECTION .4200 - SPECIAL CARE UNITS 10A NCAC 13B .4201 ORGANIZATION (a) The governing body shall approve the type and scope of special care units. (b) The facility shall document the relationship of the special care units to the other departments within the hospital, including cha…

10A NCAC 13B .4202 MEDICAL STAFF (a) The governing body shall provide that each special care unit or group of similar units be directed by qualified members of the medical staff whose clinical and administrative privileges have been approved by the governing board. (b) The govern…

10A NCAC 13B .4203 NURSING STAFF The supervision of nursing care for each special care unit shall be provided by a qualified registered nurse and shall include the following: (1) unit-specific orientation and competency evaluation for each staff member; (2) a staffing plan based …

10A NCAC 13B .4204 POLICIES AND PROCEDURES (a) The facility in conjunction with the medical and nursing staff shall develop written policies and procedures which guide the provision of care in a special care unit. These policies and procedures shall be approved by the medical sta…

SECTION .4300 - MATERNAL - NEONATAL SERVICES 10A NCAC 13B .4301 ORGANIZATION MATERNAL SERVICES (a) The governing body shall approve the scope of obstetric services offered based upon the level of patient need, qualifications of the credentialed staff, and resources of the facilit…

10A NCAC 13B .4302 MEDICAL STAFF MATERNAL SERVICES (a) The medical staff shall require that each birth be attended by a physician or certified nurse midwife who has documented evidence of current competence and appropriate privileges. (b) At all times medical staff with obstetric…

10A NCAC 13B .4303 NURSING SERVICES MATERNAL SERVICES (a) The nurse executive or the decentralized nursing management staff shall designate a registered nurse who has education, training, and experience in obstetrical care as supervisor of obstetrical services. (b) A registered n…

10A NCAC 13B .4304 POLICIES AND PROCEDURES MATERNAL SERVICES (a) The provision of patient care shall be guided by written policies and procedures developed by the medical and nursing staff and approved by the medical staff. (b) Written policies shall relate to at least the follow…

10A ncac 13B .4305 ORGANIZATION OF NEONATAL SERVICES (a) The governing body shall approve the scope of all neonatal services and the facility shall classify its capability in providing a range of neonatal services using the following criteria: (1) LEVEL I: Full-term and pre-term …

10A NCAC 13B .4306 MEDICAL STAFF OF NEONATAL SERVICES The medical staff shall require that the director or other designated physician in charge of the neonatal special or intensive care unit has training and experience in care of the neonate. History Note: Authority G.S. 131E-79;…

10A NCAC 13B .4307 NURSING STAFF OF NEONATAL SERVICES (a) The nurse executive or the decentralized nursing management staff shall designate a registered nurse who has training and experience in the care of neonates as supervisor of neonatal services. (b) A registered nurse shall …

10A NCAC 13B .4308 POLICIES AND PROCEDURES OF NEONATAL SERVICES (a) The provision of neonatal care at all levels shall be guided by written policies and procedures developed and approved by the medical and nursing staffs. (b) The policies and procedures shall include but are not …

SECTION .4400 - RESPIRATORY CARE SERVICES 10A NCAC 13B .4401 ORGANIZATION (a) The governing body shall appoint a medical director of the respiratory care service who is an anesthesiologist, pulmonologist or other qualified physician. (b) The facility shall appoint a qualified ind…

10A NCAC 13B .4402 STAFFING (a) Staffing numbers shall be determined by the types and complexities of the services offered. (b) The director of the service shall provide for the availability of trained respiratory technicians, Certified Respiratory Therapy Technicians, registry e…

10A NCAC 13B .4403 POLICIES AND PROCEDURES The facility shall establish and maintain written policies and procedures for the services offered. These shall include but are not limited to: (1) scope of services and treatment offered; (2) medication administration; (3) cleaning, ass…

SECTION .4500 - PHARMACY SERVICES AND MEDICATION ADMINISTRATION 10A NCAC 13B .4501 PROVISION OF SERVICE The facility shall provide for pharmaceutical services which are administered in accordance with the pharmacy laws of North Carolina including but not limited to G.S. 90 and G.…

10A NCAC 13B .4502 PHARMACIST (a) The pharmacy service shall be directed by a pharmacist licensed by the State of North Carolina. If a facility has a limited service as defined by the N.C. Board of Pharmacy, a part-time director of pharmacy shall have responsibility for control a…

10A NCAC 13B .4503 STAFF The director of pharmacy shall be assisted by additional pharmacists and such other personnel as the activities of the pharmacy may require to meet the pharmaceutical needs of the patients served. History Note: Authority G.S. 131E-79; Eff. January 1, 1996…