Vassileva QA

Ministry of Health National Centre of Radiobiology and Radiation Protection Radiation Protection in Medicine
Jenia Vassileva
CONTENT
Quality Assurance definition QA aspects and content Quality control program
J. Vassileva
Sofia, 12-14 October 2006
Quality ?
Is this image of high quality? Is this image of enough quality? Is it possible to be better? Is it necessary to be better?
J. Vassileva
Quality ?
Effective diagnosis right diagnosis in time diagnosis Effective treatment
Positive effect on a patient outcome

J. Vassileva Sofia, 12-14 October 2006
Quality = effective diagnosis

Image production Image interpretation
Visualization capability
J. Vassileva
Diagnostic accuracy
Quality = effective diagnosis

Visualization capability Diagnostic accuracy
Image quality =Useful diagnostic content

=
depends on:
imaging modality; equipment:
depends on:
knowledge and experience; availability of patient history availability of other clinical information diagnostic criteria; viewing conditions
availability; performance; operation

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Radiation risk Radiation risk

Risk of ionizing radiation depends on:
imaging modality; equipment:
performance; operation;
human factor:
education and training safety culture

Quality in Diagnostic Radiology
Image quality
Radiation doses
Price
QUALITY ASSURANCE (QA)

Quality Assurance
an organized effort by the staff operating a facility to ensure that the diagnostic images produced by the facility are of sufficiently high quality so that they consistently provide adequate diagnostic information at the lowest possible cost and with the least possible exposure of the patient to radiation
World Health Organization
Radiation Protection Optimization

ALARA = As Low As Reasonably Achievable In relation to any particular source within a practice, the magnitude of individual doses, the number of people exposed, and the likelihood of incurring exposures where these are not certain to be received should all be kept as low as reasonably achievable, economic and social factors being taken into account
International Commission on Radiological Protection
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Aim of Quality Assurance

QA is a vital part of radiological protection Because most procedures causing medical exposures are clearly justified and because the procedures are usually for the direct benefit of the exposed individuals, less attention had been given to the optimization of protection in medical exposure than in most other applications of radiation sources. As a result there is considerable scope for dose reduction in diagnostic radiology
ICRP 60
Radiation Protection and QA

IAEA: International Basic Safety Standards,
IBSS-96
EC: Medical Exposure Directive
97/43 Euratom
Bulgaria: Ordinance of the Ministry of Health No30 from
31 October 2005 for Protection of Individuals at Medical Exposure, State Gazette No 91 of November 15, 2005
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Quality Assurance
All those planned and systematic actions necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily complying with agreed standards.
EC Directive 97/43 Euratom BG Ordinance 30/2005
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CONTENT
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Quality Assurance
QA is a management tool, which aims to ensure that every exam in the radiology department is necessary and appropriate to the medical problems and that is performed:
according to the accepted clinical protocols; by adequately trained personnel; with properly selected and functioning equipment; to the satisfaction of patients and reference physicians; in safe conditions; at minimum costs.
Quality Assurance programs

Aspects: Regulations; Organization, administration, Physical and technical aspects Education and qualification Economical
Two components:
Quality management Quality control

J. Vassileva
Quality Management
Administrative procedures or management actions designed to verify that: the quality control techniques are performed properly and according to a planned timetable, the results of these techniques are evaluated promptly and accurately, the necessary corrective measures are taken in response to these results.
Quality Management
Quality administrative procedures also include : the assignment of responsibility for quality assurance actions; the establishment of standards of quality for equipment in the facility; the provision of adequate training; the selection of the appropriate equipment for each examination.
Quality Control (QC)

The set of operations (programming, coordinating, implementing) intended to maintain or to improve quality. It covers monitoring, evaluation and maintenance at required levels of all characteristics of performance of equipment that can be defined, measured, and controlled
EC Directive 97/43 Euratom BG Ordinance 30/2005
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Quality Control
Series of standardized tests developed to verify that: the equipment is operating satisfactorily; to detect changes in X-ray equipment function from its original level of performance. Quality control Equipment performance assessment Patient doses measurement Image quality assessment
Quality Assurance
Policy-making Administration Implementation Training and education
Equipment performance assessment Patient doses measurement Image quality assessment
At country level At hospital level At facility level

Who is involved?
At country level
regulatory authority scientific and professional organizations
Bulgaria: Ministry of Health

Ordinance No30 from 28 June 2004 for Quality Standard in Medical Imaging, State Gazette 76/31.08.2004 Ordinance No22 from 31 October 2005 for Protection of Individuals at Medical Exposure, State Gazette 91/15.11.2005
Who is involved?
At hospital level
hospital administration radiologists radiographers service engineers medical physicists
Proper education and training Good interaction and information exchange

Medical Physics Expert

Selecting and quality control of the equipment Providing advisory services and instruction on physical aspects and radiation protection
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Medical Physics Expert

BG NH Ordinance 30/2005 requires: Hospitals with more than 20 X-ray units should have at least one medical physicist Other hospitals should contract part time medical physicist Specialised departments performing interventional procedures, pediatric departments and screening centers should obtain permanent medical physics expert consultation
Radiology Department QA Program

Basic Safety Standards IAEA EC Directive 97/43 Euratom BG Ordinance 30/2005 Registrants and licensees shall establish a comprehensive Quality Assurance program for medical exposures with the participation of a medical physics experts
J. Vassileva

Should include written plan of action outlining policies and procedures Should cover:
QC testing techniques Administrative procedures to verify that:
the tests are performed regularly and correctly; the results evaluated promptly and accurately; the necessary actions taken
Should include recommendations regarding:
the responsibility for QA action, staff training, equipment standards, selection of the equipment for each examination
J. Vassileva

QA programs for medical exposures shall include : Procedures for proper selection of equipment Measurements of the physical parameters of the radiation generators and imaging devices at the time of commissioning and periodically thereafter Verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment

QA programs for medical exposures shall include : Verification of the appropriate physical and clinical factors used in patient diagnosis Written records of relevant procedures and results Regular and independent quality audit reviews of the quality assurance program
J. Vassileva
Quality Assurance
Policy-making Administration Implementation Training and education
Equipment performance assessment Patient doses measurement Image quality assessment
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CONTENT
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Radiology Department QC Program

QC programme includes : The selection of the equipment The quality control of equipment and accessories The evaluation of patient doses The adoption of optimised technique procedures
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Equipment Selection
How must an x-ray system be specifically designed for interventional radiology/cardiology? Recommended technical specification Joint WHO/IRH/CE workshop 1995 (1) : Arc system (X-ray tube below table) Overcouch image intensifier HF generator > 80 kW generator
Equipment Selection
Recommended technical specification Joint WHO/IRH/CE workshop 1995 (2) : Heat capacity of X-ray tube adequate to perform all anticipated procedures without time delay Focal spot: cardiology 1.2/0.5 mm Minimum focus skin distance 30 cm Automatic collimator to the size of the I.I. surface. Additional filtration Removable grid Pulsed fluoroscopy modes
neuroradiology 1.2/0.4 mm peripheral vascular 1.2/0.5 mm
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Equipment Selection
Recommended technical specification Joint WHO/IRH/CE workshop 1995 (3) : Image intensifier:
Cardiology: 25 cm; Neuroradiology: 30 cm; max. dose rate Peripheral vascular: 35-40 cm
Max. dose rate at the entrance surface of 25 cm Image Intensifier: (BG MH Ordinance 30/2005) Low dose rate mode available
in normal mode 0.8 Gy/s in high dose mode 1 Gy/s
Equipment Selection
Recommended technical specification Joint WHO/IRH/CE workshop 1995 (4) : 2 x magnifications Image hold system Flexibility for AEC (IMAGE or DOSE weighted) Source intensifier distance tracking Roadmapping (use of a reference image on which the current image is overlayed) Region of Interest (ROI) fluoroscopy: a low noise image in the centre is presented surrounded by a low dose (noisy) region.
Equipment Selection
Recommended technical specification Joint WHO/IRH/CE workshop 1995 (5) : Use of audible dose or dose rate alarms is not considered appropriate (cause of confusion) Dose-area product (DAP) meter Display of :
fluoroscopy time, total DAP (fluoroscopy and radiographic) estimated skin entrance dose.
Provision of Staff protective shielding
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Equipment Selection
Recommended technical specification Joint WHO/IRH/CE workshop 1995 (5) : All instrumentation and switches clearly labeled Maximum size of image store Availability of an automatic injector is desirable Concave couch top for patient comfort Means of patient immobilization
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Equipment Quality Control

Type test
(BG MH Ordinance 30/2005) Acceptance test (performed by the supplier) To ensure correct operation of safety features To verify that the conditions of contract have been met Commissioning tests To ensure that the equipment is ready for clinical use Routine constancy (periodical) tests To detect significant changes in performance during use
Written protocols are required!

Quality Control Program

STAGE
E quipm ent selectio n
W HAT TO DO?
S pe cification and contract
W H O TO DO?
D epa rtm ent m ana gem e nt
W HEN TO DO?
A t plannin g an d contractin g
Instalation
A cceptan ce tets
Installer
A fter installation befo re putting in ope ration A t putting in ope ration P erio dically M inim um yea rly
P utting in ope ration
C om m issio ning
M edical p hysics exp ert
C linical use
R outine con stan cy tests A cceptan ce test
M edical p hysicist/ techn ologists
R epair
S ervice
A fter re pair B efore putting in ope ration
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Commissioning tests
BG MH Ordinance 30/2005 To ensure that the equipment satisfy national requirements for clinical use (Appendix 8) Extensive performance measurements to ensure that the equipment will perform satisfactorily in clinical practice. Establish baseline values as a reference for future routine quality control tests. Need to be performed when major items have been replaced e.g. X-ray tube, image intensifier, etc. Performed by Medical Physics expert For the equipment in use an initial test to be performed in maximum 2 years after the enforcement of the Ordinance
Commissioning tests
Tube and generator:
Tube voltage accuracy and reproducibility Filtration Focal spot size Radiation/image field size and virtual collimation: Alignment of the X-ray field with the Image Intensifier (with image visible on the TV monitor)
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Commissioning tests
Dosimetric characteristics:
Dose rate at the entrance surface of a phantom under automatic exposure control (AEC) - on all field sizes and commonly used fluoroscopy options (high dose rate, pulsed rate, etc.) Dose rate at the input face of the image receptor under AEC - on all field sizes and commonly used fluoroscopy options (high dose rate, pulsed rate, etc.) Dose per image at the input face of the image receptor under automatic fluorographic (acquisition) exposure control
Commissioning tests
Image quality
High contrast resolution
BG MH Ordinance 30/2005:
1,0 lp/mm for > 30 cm II; 1,2 lp/mm for 27-30 cm II 1,4 lp/mm for 23-25 cm II
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Commissioning tests
Image quality
Low contrast resolution
4 % contrast
Commissioning tests
Image quality
Image Distortion
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Commissioning tests
Monitors
Resolution Greyscale
Not regulated
Routine Constancy Tests

They ensure the constancy of the good performance of a radiological installation Tests undertaken:
regularly (minimum once per year) after maintenance after repairs to detect any change in the equipment performance
The same parameters and methods used for commissioning tests Any deviation from the baseline values necessitates further investigation Performed by medical physicist or other staff of the department
Routine constancy Tests

BG MH Ordinance 30/2005: Two action levels: - remedial level - suspension level
Suspension level Remedial level Baseline Remedial level Suspension level
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Stop clinical use Correction action needed Optimal work Optimal work Correction action needed Stop clinical use
x x x x x

Parameter to be tested
1
Level of expertise
2
Minimal frequency
3
Remedial level (Criteria for normal work)

4
Suspension level (Criteria for safety work)

5
Equipment in use: if doesnt meet the criteria for safety work should be withdrawn immediately from clinical use and replaced New equipment should meet all the criteria In 5 years after enforcement of the Ordinance all radiological equipment should meet ALL the requirements

Quality control of Lead Aprons
J. Vassileva

Lead Aprons should always be put away properly in order to avoid them getting damaged!
J. Vassileva

J. Vassileva
Evaluation of patient doses

Regular constancy testing ensures that the patient dose is kept at an optimum level as a number of constancy tests are directly related to patient dose. A gradual increase in input dose rate to an image intensifier would result in an increase in patient doses but would be detected and corrected by appropriate regular testing. The ultimate check on whether patient doses are indeed acceptably low is to make direct assessments of dose on groups of patients and to compare the results with some acceptable standard.
Evaluation of patient doses

Dosimetric parameters 1 For stochastic effects estimation
Dose area product (DAP) - measurements Effective dose calculations
2For deterministic effects
Entrance surface (skin) dose TLDs film
small Si-sensors
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Optimised Technique Procedures

QA is not just about producing quality images it also requires those images to be produced at acceptable dose levels. Directive 97/43: Diagnostic Reference Levels (DRLs) These levels are expected not to be exceeded when good and normal practice regarding diagnostic and technical performance is applied
DIMOND Reference levels DAP (Gycm2) Minutes fluoroscopy Number of frames
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CA 57 6 1270
PTCA 94 16 1355

FDA Recommendations for IR (1994) http://www.fda.gov/cdrh/fluor.html To establish standard operating procedures and clinical protocols for each specific type of procedure performed. To know the radiation dose rates for the specific fluoroscopic system and for each mode of operation used during the clinical protocol. To assess the impact of each procedure's protocol on the potential for radiation injury to the patient.
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FDA Recommendations for IR (1994) http://www.fda.gov/cdrh/fluor.html To modify the protocol, as appropriate, to limit the cumulative absorbed dose to any irradiated area of the skin to the minimum necessary for the clinical tasks, and particularly to avoid approaching cumulative doses that would induce unacceptable adverse effects To use equipment that aids in minimizing absorbed dose To enlist a qualified medical physicist to assist in implementing these principles in such a manner so as not to adversely affect the clinical objectives of the procedure
Clinical Audit
Systematic examination or review of medical radiological procedures which seeks to improve the quality and the outcome of patient care through structured review whereby radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices where indicated and the application of new standards if necessary at local level (internal audit) at national level (external audit) -BG MH Ordinance 30/2005 and Medical Standard on Diagnostic Imaging requires external clinical audit to be performed each 2 years -Accreditation requirements for hospitals
Conclusion
Many physical, technical and subjective factors affect greatly patient dose and image quality in interventional radiology/cardiology. The equipment used in these fields should be part of a rigorous quality assurance programme. Practitioners should be aware of such recommendations.
Quality Assurance is:
a vital part of radiological protection an open system it is develop with implementation in clinical practice of new techniques and new imaging methods
J. Vassileva

Vassileva QA

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Ministry of Health National Centre of Radiobiology and Radiation Protection Radiation Protection in Medicine

Sofia, 12-14 October 2006

Sofia, 12-14 October 2006

Positive effect on a patient outcome

Quality = effective diagnosis

Quality = effective diagnosis

Image quality =Useful diagnostic content

availability; performance; operation

Radiation risk Radiation risk

education and training safety culture

Quality in Diagnostic Radiology

QUALITY ASSURANCE (QA)

Radiation Protection Optimization

Sofia, 12-14 October 2006

Aim of Quality Assurance

Radiation Protection and QA

EC: Medical Exposure Directive

Bulgaria: Ordinance of the Ministry of Health No30 from

Sofia, 12-14 October 2006

Sofia, 12-14 October 2006

Sofia, 12-14 October 2006

Quality Assurance programs

Quality management Quality control

Quality Control (QC)

Sofia, 12-14 October 2006

Policy-making Administration Implementation Training and education

Equipment performance assessment Patient doses measurement Image quality assessment

At country level At hospital level At facility level

Bulgaria: Ministry of Health

Proper education and training Good interaction and information exchange

Medical Physics Expert

Sofia, 12-14 October 2006

Medical Physics Expert

Radiology Department QA Program

Sofia, 12-14 October 2006

Radiology Department QA Program

Should include recommendations regarding:

Radiology Department QA Program

Radiology Department QA Program

Sofia, 12-14 October 2006

Policy-making Administration Implementation Training and education

Equipment performance assessment Patient doses measurement Image quality assessment

Sofia, 12-14 October 2006

Sofia, 12-14 October 2006

Radiology Department QC Program

Sofia, 12-14 October 2006

Sofia, 12-14 October 2006

in normal mode 0.8 Gy/s in high dose mode 1 Gy/s

Provision of Staff protective shielding

Sofia, 12-14 October 2006

Sofia, 12-14 October 2006

Radiology Department QC Program

Sofia, 12-14 October 2006

Equipment Quality Control

Written protocols are required!

Quality Control Program

P utting in ope ration

M edical p hysics exp ert

R outine con stan cy tests A cceptan ce test

M edical p hysicist/ techn ologists

A fter re pair B efore putting in ope ration

Sofia, 12-14 October 2006