W. Va. Code R. § 64-12-10 - Adjunct Diagnostic Services and Treatment Departments

10.1. General Requirements.

10.1.1. The hospital shall develop and maintain all ancillary diagnostic and treatment departments in accordance with section 5 of this rule.

10.1.2. The hospital shall locate ancillary patient departments conveniently to provide services to all patient populations.

10.1.3. A waiting area for patients shall provide for patient comfort and confidentiality.

10.1.4. The hospital shall provide toilets for ambulatory patients and the public.

10.1.5. The hospital shall ensure that all ancillary diagnostic services and treatment departments shall maintain current policy and procedure manuals approved by the medical staff. These manuals shall be reviewed and revised, as necessary, but at least, every three years.

10.1.6. All outpatient specialty services such as outpatient surgery and cardiac catheterization laboratory shall be equipped and maintained according to current professional standards.

10.2. Laboratory Department.

10.2.1. The hospital shall maintain, either directly or through contractual agreement with a certified laboratory, adequate laboratory services to meet the needs of the patients.

10.2.2. The hospital shall ensure that all laboratory services provided to patients are performed in a facility certified in accordance with 42 C.F.R. §493, and the 1988 Clinical Laboratory Improvement Amendments (CLIA).

10.2.3. Emergency laboratory services shall be available 24 hours a day.

10.2.4. Laboratory personnel shall be in sufficient numbers for the scope and complexity of services provided.

10.2.5. The hospital shall provide laboratory personnel with in-service training appropriate to the type and complexity of the services offered on a regularly scheduled basis as defined by hospital policy.

10.2.6. The hospital shall provide space for administrative services and clean-up and decontamination of equipment.

10.2.7. A written description of services provided shall be readily available to the medical staff.

10.3. Blood and Blood Products.

10.3.1. The hospital shall maintain a process for procurement, safekeeping, and transfusion of blood and provide that blood products are provided or readily available.

10.3.2. Blood shall be obtained, processed, stored, and administered under the supervision of a pathologist or designated physician.

10.3.3. The hospital shall make arrangements for procurement, transfer, and availability of blood types not ordinarily kept at the hospital.

10.3.4. Blood storage facilities in the hospital shall have an adequate temperature alarm system that is regularly inspected according to hospital policy.

10.3.5. The hospital shall evaluate blood use through the hospital quality improvement program. A pathologist, designated physician, or both shall be included in this evaluation.

10.3.6. The hospital shall ensure that all transfusion-related fatalities are investigated and reported as required by the provisions of 21 C.F.R. §606.170.

10.3.7. The hospital shall ensure that the laboratory is properly registered, if appropriate, as required by the Federal Food, Drug, and Cosmetic Act, 42 C.F.R. §417.124(2)(i)(ii)(iii)(iv).

10.3.8. The hospital shall have a process to take action if it has received or administered HIV blood or blood products in accordance with 42 C.F.R. §482.27.

10.4. Radiology and Imaging Service.

10.4.1. The hospital shall maintain, or have available, diagnostic radiology services to meet the needs of the patients.

10.4.2. If therapeutic and diagnostic services are provided, they shall be administered according to professionally approved standards for safety and personnel qualifications.

10.4.3. Radiology services shall only be provided according to a practitioner's orders consistent with state law, as authorized by the medical staff and the governing body.

10.4.4. Radiology services shall be under the medical direction of a qualified full-time, part-time, or consulting radiologist. A qualified radiologist is a Doctor of Medicine or Osteopathy who is qualified by education and experience in radiology and is licensed by the West Virginia Board of Medicine or West Virginia Board of Osteopathy. A radiologist's responsibilities shall include:

10.4.4.a. Ensuring that radiology reports are signed by the practitioner who interpreted them;

10.4.4.b. Enforcing safety and infection control standards;

10.4.4.c. Assigning duties to radiology personnel based on their training, experience, and licensure when applicable;

10.4.4.d. Ensuring files, scans, and other image records are secure, retrievable, and maintained for a minimum of five years; and

10.4.4.e. Providing in-services and training to radiology personnel including management of radiation hazards and equipment safety, etc.

10.4.5. A radiologist shall interpret all imaging tests, except in cases where the medical staff has determined through its credentialing process that a test can be interpreted by another physician who has equal training and expertise in performing and interpreting certain designated tests.

10.4.6. Proper safety precautions shall be maintained against radiation hazards in compliance with the Department of Health Legislative Rule, Radiological Health Rules, 64CSR23, including:

10.4.6.a. Adequate shielding for patients, personnel, and facilities; and

10.4.6.b. Appropriate storage, use, and disposal of radioactive materials.

10.4.7. The hospital shall make periodic inspections of equipment according to hospital policy and any identified hazards shall be corrected promptly.

10.4.8. The hospital shall periodically check radiology service personnel, and other appropriate personnel, by the use of exposure meters or badge tests, according to hospital policy, to determine the amount of radiation exposure to which they may have been exposed.

10.4.9. Only radiology technologists or other individuals licensed in West Virginia or other individuals approved by hospital policy may operate radiology equipment and administer procedures pursuant to W. Va. Code §30-23-1, et seq.

10.4.10. The radiology service area shall have at least:

10.4.10.a. One radiographic room with adequate radiology equipment;

10.4.10.b. A darkroom unless a 100 percent filmless environment negates the need for a darkroom;

10.4.10.c. An office, viewing facilities, and film filing cabinets for both active and inactive records. This may be in one room in a small radiology department;

10.4.10.d. Dressing booths with an adjoining toilet and lavatory for patients;

10.4.10.e. Waiting space under the supervision of qualified personnel for patients using stretchers or wheelchairs;

10.4.10.f. A utility area with a sink and counter space; and

10.4.10.g. Supply and equipment storage space.

10.4.11. Therapeutic radiology and radiological isotopes, if provided, shall be provided according to current national professional standards.

10.5. Rehabilitation Service.

10.5.1. The hospital, if it provides rehabilitation, physical therapy, occupational therapy, audiology, sports medicine, or speech pathology services, shall organize those services and make staff available to ensure the health and safety of patients.

10.5.2. If any or all of the services referenced in subdivision 10.5.1. are provided, they shall be provided by a sufficient number of staff who meets the qualifications specified by the medical staff, consistent with state law. The number of qualified staff is based upon the type of patients treated and the frequency, duration, and complexity of treatment required.

10.5.3. Each service, whether provided through a single discipline department or within a multi-discipline department, shall function with established lines of authority and responsibility that ensure accountability in patient care and administrative matters regarding the provision of the service.

10.5.4. Each service shall be accountable to an individual who directs the overall operation of the service.

10.5.5. The director of the services shall have the necessary knowledge, experience and capabilities to properly supervise and administer the services. An individual may serve as director of more than one service either as the director of a multi-service department or as the director of single service departments. The director may serve on either a full-time or part-time basis.

10.5.6. A qualified professional defined by medical staff policy, consistent with state law, shall:

10.5.6.a. Evaluate each patient;

10.5.6.b. Initiate the plan of treatment; and

10.5.6.c. Instruct and supervise supportive personnel.

10.5.7. The space and equipment required shall depend upon the services provided.

10.5.8. The hospital shall provide services in accordance with a written plan of treatment and in accordance with written orders of practitioners authorized by the medical staff.

10.5.9. The hospital shall ensure that the plan of treatment includes treatment goals and type, amount, frequency, and duration of services and shall be revised when appropriate.

10.6. Respiratory Care Services.

10.6.1. If the hospital provides respiratory care services, the scope of the diagnostic and therapeutic services offered shall be defined in writing and meet the needs of the patients.

10.6.2. Respiratory care services shall be under the medical direction of a physician licensed by the West Virginia Board of Medicine or West Virginia Board of Osteopathy with the knowledge and experience to supervise and administer the services. The director may serve on either a full-time or part-time basis.

10.6.3. The hospital shall employ adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with state law.

10.6.4. The hospital shall deliver services in accordance with medical staff directives.

10.6.5. The hospital shall provide services only in accordance with the written orders of practitioners authorized by the medical staff.

10.6.6. The hospital shall designate in writing the personnel qualified to perform specific procedure and the amount of supervision required for these individuals.

10.6.7. The hospital shall designate in writing the personnel who are qualified to provide direct supervision.

10.6.8. If blood gases or other clinical laboratory tests are performed in the respiratory care unit, the unit shall meet the requirements for clinical laboratories with respect to management, adequacy of facilities, proficiency testing, and quality control, according to 42 C.F.R. §482.27(a), (b), (c), and (f).

10.7. Additional Services.

If the hospital does not have morgue and autopsy facilities available at the hospital, the hospital shall maintain written agreements with an area mortuary, when available, or another hospital for these services to be provided.

10.8. Organ Procurement Responsibilities.

The hospital shall have and implement written protocols that ensure compliance with Condition of Participation: Organ, tissues, and eye procurement, 42 C.F.R. §482.45.

Notes

W. Va. Code R. § 64-12-10