Section 157.74. Administrative requirements.

 

(1)   General. The registrant shall be responsible for directing the operation of the x-ray systems under their administrative control. The registrant or the registrant's agent shall ensure the requirements of this section are met. An x-ray system shall meet the provisions of this subchapter to be operated for diagnostic or screening purposes. All images, hard copy or electronic, shall be interpreted by a licensed practitioner for the patient record.

(2)   Radiation safety requirements.

(a) Each individual who operates x-ray equipment shall be instructed in the safe operating procedures for each specific device and be competent in the safe use of the equipment as determined by the registrant.

(b) A chart shall be available near the control panel of a diagnostic x-ray system that specifies, for all examinations performed with that system, all of the following information:

1. Patient's body part to be examined and anatomical size, body part thickness or, for pediatrics, age versus technique factors to be utilized.

2. Type and size of the film or film-screen combination to be used.

3. Type and focal distance of the grid to be used, if any.

4. Except for dental intra-oral radiography, source to image receptor distance to be used.

5. Type and location of placement of patient shielding to be used.

(c) The registrant of a facility shall create and make available to x-ray operators written safety procedures, including patient holding procedures and any restrictions of the operating technique required for the safe operation of the particular x-ray system. The operator shall be able to demonstrate familiarity with these procedures.

(d) Only the staff, ancillary personnel or other persons required for the medical procedure or training may be in the room during the radiographic exposure. Other than the patient, the following applies to all persons in the room:

1. All persons shall be positioned such that no part of the body will be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material. If the hands must be in the beam and unprotected, a ring badge on the hand in the beam shall be worn unless contraindicated by the clinical procedure.

2. All persons, including any patients who cannot be removed from the room, shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or shall be so positioned that all parts of the person's body are at least 2 meters from all of the following:

a. The tube head.

b. The direct beam.

c. The nearest part of the examined patient's body being struck by the useful beam.

3. Operators of c-arm configuration units which do not operate at a tube current in excess of 0.2 mA are exempt from the requirement to wear a leaded apron, provided the operator wears a personnel dosimeter as required under s. DHS 157.25 (2) .

(e) Gonad shielding of not less than 0.5 millimeter lead equivalent material shall be used for human patients who have not passed the reproductive age during radiographic procedures in which the gonads are in the useful beam, except for cases in which the shielding would interfere with the diagnostic procedure or for computed radiographic examinations.

(f) Persons may not be exposed to the useful beam except for healing arts purposes and unless such exposure has been authorized by a licensed practitioner of the healing arts. Deliberate exposure for any of the following purposes is prohibited:

1. Exposure of a person for training, demonstration or other non-healing arts purpose.

2. Exposure of a person for healing arts screening, except as authorized by the department.

(g) When a patient or film must be provided with additional support during a radiation exposure, all of the following applies:

1. The human holder shall be instructed in personal radiation safety and protected as required by subd. 2. Written safety procedures are required.

2. In those cases where the patient must hold the film, any portion of the body other than the area of clinical interest struck by the useful beam shall be protected by not less than 0.5 millimeter lead equivalent material.

3. Each facility shall have leaded shielding garments and devices available in sufficient numbers to provide protection to all personnel who are involved with x-ray operations and who are otherwise not shielded.

4. Leaded shielding garments and devices shall be fluoroscopically or radiographically inspected at least every 2 years for defects and replaced if defective.

5. If visual inspection reveals possible defects, radiographic or fluoroscopic inspections shall be performed.

(h) Procedures and auxiliary equipment designed to minimize patient and personnel exposure commensurate with the needed diagnostic information shall be utilized, as follows:

1. The speed of the screen and film combinations used shall be of a speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens may not be used for any routine diagnostic radiological imaging, with the exception of veterinary radiography and standard film packets for intra-oral use in dental radiography.

2. The radiation exposure to the patient shall be the minimum exposure required to produce images of good diagnostic quality.

3. An x-ray system may not be utilized in a procedure where the source to patient distance is less than 30 centimeters, except for a veterinary system, bone density unit or a unit granted an exemption by the US food and drug administration.

4. If grids are used between the patient and the image receptor to decrease scatter to the film and improve contrast, the grid shall meet all of the following requirements:

a. Be positioned with tube side facing the in right direction, and grid centered to the central ray.

b. Be of the proper focal distance for the SIDs being used. Grids shall be of the proper ratio to adequately reduce scatter for the procedure being performed.

c. Antiscatter grids or an appropriate air gap technique to reduce scatter to the image receptor shall be used for all x-ray examinations of the human torso utilizing stationary x-ray equipment for patients 12 years of age or older.

(i) All persons associated with the operation of an x-ray system are subject to the requirements of s. DHS 157.22 (1) , (5) , (7) and (8) .

(j) A person proposing to conduct a healing arts screening program may not initiate a program without the department's prior approval. When requesting approval, the person shall submit the information outlined in Appendix M. If any information submitted to the department becomes invalid or outdated, the department shall be immediately notified.

(k) All facilities performing mammography shall meet the requirements of 21 CFR 900 , US food and drug administration, Mammography Quality Standards Act.

(L) A registrant that uses two or more therapeutic radiation machines for human use shall establish a radiation safety committee consisting of at least three members to oversee the use of all therapeutic radiation machines. The committee shall include an operator authorized by the registrant, a representative of the institution's management, and the radiation safety officer. If the institution has a radiation safety committee established under s. DHS 157.61 (1) (e) , this committee may be designated to oversee the use of all therapeutic radiation machines, if an operator authorized by the registrant is appointed to this committee.

(3)   X-ray image processing equipment and processing procedures.

(a) Film.

1. Each installation using a radiographic x-ray system for human diagnosis or screening and using analog image receptors shall have available suitable equipment for handling and processing radiographic film according to the film and chemistry manufacturer's instructions.

2. Quality control and maintenance procedures shall be performed on a regular schedule according to the device manufacturer's recommendations.

3. X-ray film processing control tests shall be performed and analyzed on days when human patient films are being processed and prior to the processing of the first films of the day, except dental and podiatry facilities. If analysis shows that the image quality has declined, corrective action shall be taken prior to processing patient films.

4. X-ray film processors in dental and podiatry facilities shall be tested at least once a week.

(b) Digital imaging systems.

1. Each installation using a digital radiographic x-ray system for human diagnosis or screening shall have available suitable equipment for handling and processing the radiographic digital image according to the manufacturer's instructions.

2. Quality control and maintenance procedures shall be performed on a regular schedule according to the device manufacturer's recommendations. If analysis shows that the system test results fall outside the device manufacturer's recommended limits corrective action shall be taken prior to performing patient examinations.

(4)   Other requirements.

(a) Pass boxes, if provided, shall be constructed to exclude light from the darkroom when cassettes are placed in or removed from the boxes and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

(b) The darkroom shall be light tight with proper safelights so that any film type in use exposed in a cassette to x-radiation sufficient to produce an optical density from one to 2 when processed may not suffer an increase in density greater than 0.1, or 0.05 for mammography, when exposed in the darkroom for 2 minutes with all safelights on. This test shall be performed at least once every 6 months. If used, daylight film handling boxes shall preclude fogging of the film. Darkrooms typically used by more than one person shall be provided a method to prevent accidental entry while undeveloped films are being handled or processed.

(c) Film shall be stored according to the manufacturer's requirements and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light tight container.

(d) Film cassettes and intensifying screens shall be inspected periodically and shall be cleaned and replaced as necessary and consistent with the manufacturer's instructions to best assure radiographs of good diagnostic quality.

(e) Outdated x-ray film may not be used for diagnostic radiographs.

(f) Film developing solutions shall be prepared using instructions given by the manufacturer and maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

CR 01-108 : cr. Register July 2002 No. 559 , eff. 8-1-02; CR 06-021 : am. (2) (b) (intro.), (g) 3., 4., (3) (c) and (4) (b), cr. (2) (d) 3. and (g) 5. Register October 2006 No. 610 , eff. 11-1-06; CR 09-062 : am. (2) (g) 4. and (3) (title), cr. (2) (L), (3) (a) (title) and (b), renum. (3) (a) to (d) to be (3) (a) 1. to 4. Register April 2010 No. 652 , eff. 5-1-10.

Note

This chart may be electronic in the form of pre-programmed controls. Microsoft Windows NT 6.1.7601 Service Pack 1 The procedure for requesting permission to conduct screening x-ray examination is in Appendix M. Microsoft Windows NT 6.1.7601 Service Pack 1 Leaded shielding garments and devices include aprons, gloves, vests, skirts, thyroid shields and gonadal shields. Microsoft Windows NT 6.1.7601 Service Pack 1