Inspections of X-Ray Facilities for Medical Diagnostic Purposes
At SCI performs Inspections in X-Ray Installations for Medical Diagnostic Purposes, with the objective that they exercise their activity under the total and absolute legality. Our Technical Unit for Radiological Protection (UTPR), recognized by the Nuclear Safety Council (CSN), performs the following services in the medical radiodiagnostic facilities:
UTPR’S ROLE IN MEDICAL RX FACILITIES
Quality control of X-Ray equipment
On an annual basis, the UTPR of SCI conducts a Quality Control of its customers’ X-ray Emitting Equipment, to ensure the production of images of the best possible quality for diagnosis and that the doses received by patients are as low as reasonably achievable, while respecting the general aspects of radiological protection.
Quality control is performed in accordance with the procedures set forth in the Spanish Protocol for Quality Control in Radiodiagnosis, applying the tolerances established therein and in Royal Decree 1976/1999.
In the event that the values obtained exceed the tolerances established for a piece of equipment, the facility managerdetermine, taking into account the evolution of the patient dose and radiographic image quality indicators, the actions to be taken: revision of the equipment, more frequent quality controls, alteration of work procedures, temporary suspension of the equipment until it is repaired, etc…
Measurement of radiation levels
The SCI’s UTPR performs annually, and whenever the usual working conditions are modified or any irregularity affecting radiation protection is detected, the monitoring of the Radiation levels at workplaces and in the surrounding areas accessible to the public, in the areas where RX facilities of its customers.
Estimation of incoming dose to patients
Annually, SCI’ s UTPR performs a Patient Dose Estimate for one of the most frequently performed scans for each of the X-ray machines at its customers’ facilities. This estimate is determined by a specialist in hospital radiophysics.
Preparation of documentation for registration or modification of X-ray facilities.
As indicated in Royal Decree 1085/2009, of July 3, 2009, approving the Regulations on the installation and use of X-ray equipment For medical diagnostic purposes, the Owner of the Facility must declare before the competent Body of the Autonomous Community, the medical diagnostic X-ray facility before it is put into operation, and when there are changes in the equipment or the incorporation of additional equipment, generators or tubes, the change of location of the facility and the modification in the general layout of the facility.
It must also notify the competent body of the Autonomous Community of the change in ownership, as well as the cessation of activities, which must be accompanied by documentation that accredits the destination of the equipment.
When requested by a client, SCI’ s UTPR will take care of the necessary documentation for the registration or modification of a medical diagnostic RX facility, as long as the facility complies with the requirements of R.D. 1085/2009. Part of this documentation will be a certificate of conformity of the installation issued by the UTPR.
Development of radiation protection program
The Royal Decree 1085/2009, of July 3, 2009, which approves the Regulation on the installation and use of electrical and electronic devices. X-rays for medical diagnostic purposes, establishes the obligation for all medical radiodiagnosis facilities to define and implement an Radiation Protection Program, which establishes all the operating and performance standards required to comply with the Regulation on Health Protection against Ionizing Radiation.
The objective of this Program is to ensure that doses to workers and the public are kept as low as reasonably achievable and that, in all cases, they remain below the dose limits established in the legislation.
SCI’ s UTPR prepares the Radiation Protection Program for its clients’ facilities and monitors compliance with it.
Development of quality assurance program
Royal Decree 1976/1999, of December 23, 1999, which establishes the quality criteria in radiodiagnosis, establishes the obligation to develop a Quality Assurance Program, in accordance with national or international protocols, for X-ray facilities for medical diagnostic purposes.
SCI’ s UTPR prepares the Quality Assurance Program for its clients’ facilities whenever requested by the client.
Certificate of Conformity for X-Ray Installations
SCI’ s UTPR issues the periodic Certificate of Conformity of its clients’ RX installations, as indicated in R.D. 1085/2009. This certificate states:
That the material characteristics included in the current inscription of the installation in the registry of X-Ray Installations for Medical Diagnosis are maintained.
That the Facility’s Radiation Protection Program is being complied with, indicating, if applicable, the deviations observed.
The periodicity of this certificate will depend on the type of installation in question. R.D. 1085/2009 establishes the classification of installations and the frequency of issuance of the certificate according to the type of installation.
Periodic report to the CSN
R.D. 1085/2009 indicates, depending on the type of facility, whether the licensee of the facility must submit a report to the CSN, as well as the frequency with which this must be done.
SCI’ s UTPR performs periodic reports on all those clients who have authorized it to do so.
The contents of the report are:
Certificate of conformity of the installation.
Certificates of verification after interventions or repairs of RX equipment.
Summary of the dosimetry of the exposed personnel of the facility.
Results of annual verifications of the radiation levels of workstations and adjacent areas accessible to the public.
This report is sent in the first quarter of the following period, taking into account the periodicity indicated for the different types of installations.
The UTPR, when requested by the client, calculates the necessary shielding for the installation. These shields are intended to protect both healthcare personnel and the patients who visit them by lowering the level of radiation exposure in accordance with the law in force.
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