1. (a) Radiology.

   1. (1) Each hospital shall have shockproof diagnostic X-ray facilities.

   2. (2)

      1. (A) Radiological services shall be under the direction of a physician who is a member of the medical staff.
      2. (B) The physician director shall be certified or eligible for examination by the American Board of Radiology.
      3. (C)

2. (i) At a minimum, a board-certified radiologist shall be available on a consultative basis.

   1. (ii) Documentation of the radiologist’s visits shall be required.

   2. (3) Radiological services shall be supervised by a technologist who:

      1. (A) Is qualified by experience or education; and
      2. (B) Has at least two (2) years’ technical experience.

   3. (4) A radiologic technologist with at least two (2) years’ training shall be:

      1. (A) On duty twenty-four (24) hours; or
      2. (B) On call at all times.

   4. (5) Radiologic staff who use the radiologic equipment and administer procedures shall have:

      1. (A) Written verification of training; and
      2. (B) Approval in writing by the physician director.
   5. (6) Radiologic technologists shall not independently perform fluoroscopic procedures.

   6. (7)

      1. (A) Radiologic staff who administer agents for diagnostic purposes shall have written verification of training.

      2. (B) A current list of radiology employees who administer agents for diagnostic purposes shall be:

         1. (i) Approved by the physician director; and
         2. (ii) Maintained by the facility.
   7. (8) Radiology personnel who participate in direct patient care shall maintain competency in life support measures or the equivalent.

   8. (9)

      1. (A) Clinically relevant educational programs shall be conducted at regularly scheduled intervals with not less than twelve (12) per year.

      2. (B) There shall be evidence of:

         1. (i) Program dates;
         2. (ii) Attendance; and
         3. (iii) Subject matter.

   9. (10)

      1. (A) Policies and procedures for the department shall have evidence of ongoing review and/or revision.

      2. (B) The first page of each manual shall have the:

         1. (i) Annual review date; and
         2. (ii) Signature of the department and/or person or persons conducting the review.

      3. (C) Policies and procedures shall include:

         1. (i) Job descriptions for every type of employee;
         2. (ii) A written list of all tests/procedures performed by the radiology department, and the list shall be available to the medical staff;
         3. (iii) Infection prevention and control measures;
         4. (iv) The holding of patients;
         5. (v) Orientation practices for new employees;
         6. (vi) Operation of equipment;
         7. (vii) Management of an adverse reaction;
         8. (viii) Cleaning and disinfecting procedures; and
         9. (ix) Posting of signs.

   10. (11) Radiology personnel shall receive yearly instruction in:

       1. (A) Safety precautions; and
       2. (B) Managing emergency radiation hazards and accidents.

   11. (12) A documented preventive maintenance and quality control program shall include:

       1. (A) Radiology personnel shall follow the dosimetry requirements identified in the Rules for Control of Sources of Ionizing Radiation, 20 CAR pt. 3;

       2. (B)

          1. (i) Preventive maintenance for all diagnostic and therapeutic radiologic equipment to ensure a safe working condition.
          2. (ii) Safety and calibration checks shall be made according to manufacturer’s directions, not exceeding one (1) year intervals;

       3. (C) Annual inspection of all leaded gloves, aprons, and similar protective devices at least once a year with documentation to include the:

          1. (i) Name of the examiner;
          2. (ii) Identification of the protective device examined; and
          3. (iii) Results plus corrective action taken;
       4. (D) Documentation of safety, calibration, and inspection checks maintained for the life of the equipment; and

       5. (E) Remedial and corrective action recorded in response to equipment “down time”, with documentation to include the:

          1. (i) Piece of equipment involved;
          2. (ii) Time/date malfunction occurred;
          3. (iii) Action taken; and
          4. (iv) Time/date when the equipment became operational.
   12. (13) X-ray films shall not be stored in radiologic examination rooms.
   13. (14) X-ray films shall be filed according to a recognized filing system.

   14. (15) X-ray prescription/work requests shall:

       1. (A) Be authorized by a written and signed physician’s order; and

       2. (B) Include the following:

          1. (i) Identification of the patient;
          2. (ii) Date the test was ordered;
          3. (iii) Physician’s name;
          4. (iv) Concise statement as to the reason why the X-ray/test was ordered; and
          5. (v) Originator’s signature.

   15. (16) The radiologic report shall be:

       1. (A) Signed by a physician; and
       2. (B) Placed in the medical record.

   16. (17)

       1. (A) The radiological services shall have an ongoing QA/PI program that addresses patient care issues.

       2. (B) A mechanism for reporting results of audits shall be provided, to include:

          1. (i) Indicators monitored;
          2. (ii) Thresholds/standards;
          3. (iii) Results;
          4. (iv) Corrective plan/corrective action taken; and
          5. (v) Follow-up.
   17. (18) This part establishes requirements for radiology that are in addition to, not in substitution of, the Department of Health Rules for Control of Sources of Ionizing Radiation.
   18. (19) Actual X-ray film shall be retained for five (5) years.

   19. (20)

       1. (A) X-ray films and reports shall be stored in a room that is equipped with a smoke detection system.
       2. (B) An extinguishing system shall be made available.
   20. (21) Locked security shall be ensured for the written reports maintained in the X-ray file when the storage area is not under the direct supervision of radiology personnel.
   21. (22) Dual image viewing shall be available in the OR, ER, and radiology areas.
   22. (23) Facilities shall maintain the capacity to view X-ray films.

3. (b) Nuclear medicine services.

   1. (1) Nuclear medicine procedures shall be under the direction of a physician, qualified in nuclear medicine, who is a member of the medical staff.

   2. (2) Nuclear medicine services shall be supervised by a nuclear medicine technologist who has:

      1. (A) Completed certification requirements; and
      2. (B) At least two (2) years’ technical experience.

   3. (3) Nuclear medicine staff who use the equipment and administer procedures shall have:

      1. (A) Written verification of training; and
      2. (B) Approval in writing by the physician director and medical staff.

   4. (4) All radioactive materials shall be purchased, stored, administered, and disposed of in a manner consistent with the:

      1. (A) Requirements of the Department of Health Rules for Control of Sources of Ionizing Radiation; or
      2. (B) Specific condition of a radioactive material license issued pursuant to this part.

   5. (5)

      1. (A) The policy and procedure manual shall be reviewed annually and revised as necessary.

      2. (B) Included in the manual shall be a cover page with:

         1. (i) Signatures of those reviewing the manual; and
         2. (ii) A month/day/year of review.

      3. (C) The policies and procedures shall include:

         1. (i) Job description for each employee;
         2. (ii) A list of tests/procedures performed by nuclear medicine;
         3. (iii) Safety practices;
         4. (iv) Management of an adverse reaction;
         5. (v) Orientation for new employees;
         6. (vi) Operation of equipment;
         7. (vii) Cleaning and disinfecting procedures;
         8. (viii) Posting of signs;
         9. (ix) Quality control;
         10. (x) Quality assurance/performance improvement;
         11. (xi) Cleanup of spills;
         12. (xii) Receipt/disposal of radioactive materials; and
         13. (xiii) A radiation safety plan.
   6. (6) All nuclear medicine personnel who participate in direct patient care shall maintain competency in life support measures.

   7. (7)

      1. (A) There shall be a documented preventive maintenance and quality control program:

         1. (i) Monitoring of nuclear medicine personnel for exposure to radiation shall be integrated over a period not to exceed one (1) month;
         2. (ii) Nuclear medicine personnel shall follow the dosimetry requirements identified in the Rules for Control of Sources of Ionizing Radiation;
         3. (iii)
4. (a) (a) All nuclear medicine equipment shall be maintained in safe working condition.

5. (b) (b) Preventive maintenance, safety, and calibration checks shall be made according to manufacturer’s directions, not to exceed one-year interval;

   1. (iv) Documentation of all safety, calibration, and inspection checks shall be maintained for the life of the equipment; and

      1. (v) Remedial and corrective action shall be recorded in response to equipment “down time.”

      2. (B) Documentation shall include the:

         1. (i) Piece of equipment involved;
         2. (ii) Time/date malfunction occurred;
         3. (iii) Action taken; and
         4. (iv) Time/date when equipment became operational again.
   2. (8) The nuclear medicine “hot lab” shall be kept locked when not under the direct supervision of authorized personnel.
   3. (9) There shall be an emergency eye wash available in the nuclear medicine “hot lab”.
   4. (10) All nuclear medicine staff who administer agents for diagnostic purposes shall have written verification of training and approval by the physician director and individual or individuals supervising the training.

   5. (11)

      1. (A) Clinically relevant educational programs shall be conducted on regularly scheduled intervals at not less than twelve (12) per year.

      2. (B) There shall be evidence of:

         1. (i) Program dates;
         2. (ii) Attendance; and
         3. (iii) Subject matter.

   6. (12) All nuclear medicine requests shall:

      1. (A) Be authorized by a written and signed physician’s order; and

      2. (B) Include the following:

         1. (i) Identification of the patient;
         2. (ii) Date;
         3. (iii) Physician’s name;
         4. (iv) Originator’s signature; and
         5. (v) Reason/justification for the test.

   7. (13)

      1. (A) The nuclear medicine report shall be signed by a physician.
      2. (B) The original shall be placed in the medical record.
   8. (14) Films shall not be stored in radiologic or nuclear medicine examination rooms.

   9. (15) The storage of nuclear medicine films shall comply with the guidelines under this section.

      1. (c) Guidelines for mobile services.
   10. (1) The governing body and medical staff shall approve the provisions for establishing services in accordance with the following criteria:

   11. (2) General considerations.

       1. (A) The installation is governed by the following Department of Health publications:

          1. (i) This part; and
          2. (ii) Rules for Control of Sources of Ionizing Radiation;

       2. (B) Approvals shall be granted by the Department of Health:

          1. (i) Division of Health Facilities Services; and
          2. (ii) State Radiation Control Agency and the Division of Emergency Management;
       3. (C) The mobile service provider shall maintain fire, theft, general, and professional liability insurance;

   12. (3) Operating policies.

       1. (A) All examinations shall be authorized by a written and signed physician’s order.
       2. (B) Examinations shall be performed under the direction of and interpreted by a qualified physician with documented training or experience who is a member of the hospital’s medical staff.
       3. (C) Examinations shall be performed by a licensed radiologic technologist.

       4. (D) The radiology department shall maintain current policies and procedures for use of the mobile units to include:

          1. (i) Infection prevention; and
          2. (ii) Control and safety.
       5. (E) All personnel who administer agents for diagnostic purposes shall have written verification of training and approval by the physician director and individual or individuals supervising the training.
       6. (F) Hospital personnel shall transport patients to and from the mobile unit according to hospital safety policies.
       7. (G) Oxygen and emergency medical supplies shall be maintained and readily available.
       8. (H) The hospital pharmacy may provide necessary medical supplies including contrast media, but proper handling and control of dated items shall be ensured.
       9. (I) A log of all patients shall be maintained.
       10. (J) Films shall be maintained in the same manner as X-ray films.
       11. (K) Personnel who participate in direct patient care shall be competent in life support measures.
       12. (L) Contracted services shall be under current agreement and the contractor shall fulfill all requirements of this section; and
   13. (4) Refer to 20 CAR § 41-155, physical facilities — imaging suite.

Codification Notes: “ER” means emergency room. "OR" means operating room.