From run-of-the-mill intraoral x-ray systems to CT scanners and elaborate 3D imaging machines – radiographic machines, in whatever form or size, are a staple in every dental office.
In Ontario, all radiographic machines (x-rays) are governed by the Healing Arts Radiation Protection Act, R.S.O. 1990, c. 2 (often called “HARP“). HARP is administered by the Ministry of Health and Long-Term Care (the “Ministry“). If you are the owner of x-ray machinery or about to become one, HARP applies to you!
How Does HARP Affect You?
Owners of x-ray equipment need to submit or re-submit applications for approval when:
- purchasing new or used x-ray machinery;
- relocating existing x-ray machinery;
- replacing existing x-ray machinery (other than routine maintenance);
Applications generally need to include floor plans and schematics and every owner of x-ray machinery must designate a person to be a radiation protection officer (“RPO“) who will be responsible for establishing and maintaining procedures and quality tests for the safe operation of the x-ray equipment, ensuring that the equipment is maintained and meets the standards prescribed by HARP and ensuring that all x-ray operators are qualified according to HARP.
Dental offices undergo regular quality testing by approved inspectors annually and upon alteration or servicing of the machine. However, quality testing (such as photographic quality control) must be conducted every operational day by the RPO.
Sections 20(4) and 20(5) of HARP state that an inspector may enter your practice “at all reasonable times” to inspect the x-ray equipment and do whatever tests and records examinations necessary to ascertain whether your practice is in compliance with the provisions of HARP, including having the appropriate approvals for your x-ray machinery.
Records Retention
Upon inspection, you may be asked to produce certain records and information about the x-ray machinery, the qualification of the RPO, previous inspections, etc. Because of these requirements, the Ministry recommends that the following records be kept by owners of x-ray machinery:
- up to date approved plan for radiation shielding;
- quality test results up to 6 years old;
- x-ray equipment registration (Form 1); and
- proof of staff qualifications to operate x-ray machinery (such as valid professional membership to RCDSO)
It is advised by the Ministry that upon purchasing a dental practice, the purchaser (and/or the purchaser’s lawyer) should acquire all the above records in order to be compliant with HARP.
What Happens if You Don’t Comply With HARP
The Ministry-appointed inspector or the Director of the Ministry may make certain orders to ensure that you comply with the provisions of HARP and that your x-ray machinery is safe to operate.
Section 24 of HARP makes non-compliance with an order or other contraventions of HARP a criminal offence punishable by fine or imprisonment.
For an individual who is convicted for the first time, the penalty is up to a $25,000 fine and/or 12 months imprisonment. Subsequent offences can carry a fine of up to $50,000 and/or 12 months of imprisonment. Corporations may be liable anywhere from $50,000 up to $200,000 depending on whether it is a first or subsequent offence.
How to Comply
The X-Ray Inspection Service (often called “XRIS“) is the branch of the Ministry responsible for dealing with applications under HARP.
They can be reached by mail at: Ministry of Health and Long-Term Care, X-Ray Inspection Service, 1075 Bay Street, 11th Floor, Toronto, Ontario, M5S 2B1
By fax at: 416-327-8805
By email at: xris@ontario.ca
The Ministry has placed their forms online and has developed a useful information brochure for owners and operators of x-ray facilities.
If you need help navigating the XRIS forms or becoming/remaining compliant with HARP, contact DMC. We are your dental legal team.
