X-ray Equipment Inspection
Inspection
The X-ray Program is responsible for inspecting facilities that use x-ray equipment and businesses that install x-ray equipment in Ohio. Health physics inspectors travel throughout Ohio performing inspections on approximately 7,300 x-ray machines at 3,300 facilities annually.
Quality Assurance Items Reviewed at Inspection
-Current certificate of registration
-Regulations applicable to facility type
-Prior violations and corrective action review
-Notice-to-Employees postings
-Operator training
-Personnel monitoring
-Radiologic licenses
-Preventative maintenance
-Quality control tests: daily, monthly, quarterly
-Area radiation surveys
-X-ray equipment inventory
-X-ray equipment safe operating procedures
-X-ray equipment receipts, transfers and disposals
-Fluoroscopic equipment: tests by the medical physicist (radiation expert)
-Computed tomography equipment: tests by the medical physicist (radiation expert)
-Radiation therapy equipment: tests by the medical physicist (radiation expert)
-Any self-referral approval letters
-Any Food & Drug Administration (FDA) X-ray equipment variances
X-ray Equipment Tests Performed at Inspection
-Exposure, kVp and timer reproducibility
-kVp and timer accuracy
-Half-value layer
-Exposure switch position and function
-Entrance-skin exposure for examination
-Collimator and light field congruency
-Collimator beam size an alignment factors
-Safety interlocks
Inspection Time
It takes approximately 45 minutes to 1 hour to review the quality assurance documents and 15 to 20 minutes for every x-ray unit at small facilities. Hospital inspections take 1-5 days based on facility size and the organization of their documents.
Inspection Frequency
|
Facility Type |
Interval |
|
Assembler |
3 years |
|
Chiropractic |
3 years |
|
Clinic |
3 years |
|
Dental |
5 years |
|
Educational |
3 years |
|
Hospitals |
2 years |
|
Mobile Health Care |
2 years |
| Non-Medical | 3 years |
| Physician | 3 years |
| Podiatry | 3 years |
| Veterinary | 3 years |
Inspection Fee
The following is a listing of the current radiation-generating equipment inspection fees.
| Inspection type | Fee |
| Assembler | $380.00 |
| Dental | $155.00 |
| Each Additional Dental | $77.00 |
| First Medical Radiologic | $307.00 |
| Each Additional Radiographic | $163.00 |
|
First Radiation Therapy < 250 kVp |
$307.00 |
|
Each Additional Radiation Therapy < 250 kVp |
$163.00 |
|
|
|
|
Each Radiation Therapy > = 250kVp |
$610.00 |
|
Each Veterinary |
$240.00 |
|
Each Non-Medical Analytical or Cabinet |
$120.00 |
|
Each Non-Medical Radiographic |
$240.00 |
|
Each Non-Medical > 250 kVp |
$610.00 |
| Hospital 1-10 Tubes |
$960.00 |
|
Hospital 11-25 Tubes |
$1,800.00 |
|
Hospital > 25 Tubes |
$2,640.00 |
General Documents
The following are public guidance documents to assist facilities in preparation for inspections.
|
Guidance Documents |
Revision Date |
|
5/08 |
|
|
5/08 |
|
|
No Approvals for Self-Referral CT Scans – |
10/28/12 |
| 1/20 | |
| Rule Listing by Facility Type |
2/19 |
| 11/17 |
Rule Guidance
The following are public guidance documents to assist facilities in preparation for inspections and give a general explanation for how to comply with a rule.
*Guidance for rule numbers without a hyperlink are currently under development.
Guidance Chapter 3701:1-66 - Medical Radiation-Generating Equipment
3701:1-66-02 - General administrative requirements Revision Date 12/27/19
3701:1-66-04 - Quality assurance program Revision Date 12/27/19
3701:1-66-05 - Radiographic equipment Revision Date 12/27/19
3701:1-66-06 - Dental equipment Revision Date 12/27/19
3701:1-66-07 - Fluoroscopic equipment Revision Date 12/27/19
3701:1-66-08 - Mammography equipment Revision Date 12/27/19
3701:1-66-10 - Computed tomography equipment Revision Date 12/27/19
3701:1-66-11 - Bone densitometry equipment Revision Date 12/27/19
3701:1-66-17 - Medical screening and research Revision Date 12/27/19
Guidance Chapter 3701:1-67 - Therapy Radiation-Generating Equipment
3701:1-67-02 - General administrative requirements
3701:1-67-04 - Quality management program
3701:1-67-05 - Therapy equipment < 1 MV
3701:1-67-06 - Therapy equipment = or > 1 MV
3701:1-67-07 - Survey and dosimetry instruments
3701:1-67-08 - Shielding design and survey requirements
3701:1-67-09 - Quality assurance
3701:1-67-10 - Electronic brachytherapy
3701:1-67-11 - Other uses for electronic RGE for therapeutic purposes
3701:1-67-12 - Unintended treatment deviations and medical events
Guidance Chapter 3701:1-68 - Non-Medical Radiation-Generating Equipment
3701:1-68-02 - General requirements Revision Date 8/22/18
3701:1-68-03 - Radiographic systems Revision Date 12/31/18
3701:1-68-04 - Analytical systems Revision Date 11/7/18
3701:1-68-05 - Particle accelerator systems Revision Date
3701:1-68-06 - Cabinet systems Revision Date 6/5/19
Contact us
Inspection questions or complaints may be directed to any of the following:
Mailing Address:
Ohio Department of Health
Bureau of Environmental Health and Radiation Protection – X-ray Program
246 North High Street – 7th floor
Columbus, OH 43215
E-mail: Bradiation@odh.ohio.gov
Telephone: (614) 644-2727
Fax: (614) 466-0381
