Department of Health

DEPARTMENT OF HEALTH DIRECTORATE: RADIATION CONTROL CODE OF PRACTICE FOR USERS OF MEDICAL XRAY EQUIPMENT (Code: Diagnostic Use)WEB ADDRESS:

http://www.doh.gov.za/department/radiation/01.html 2

INDEX Page no.1. INTRODUCTION 3 2. ABBREVIATIONS AND DEFINITIONS 4 3. LICENSING 6 Application for Licences 6 Installations 6 Acceptance Tests 6 Disposal / modification of x-ray equipment 7 New / modified premises 7 Responsible person 7 Change of responsible person 7 4. RESPONSIBILITIES OF LICENCE HOLDER / RESPONSIBLE PERSON 8 Keeping of patient records 8 Keeping of equipment records 9 Submission of acceptance test results 9 5. OPERATORS 10 Operators of mammography units 10 6. RADIATION WORKERS 11 Pregnant radiation workers 11 Appointment of a radiation worker 11 Medical examinations 12 Monitoring 12 Termination of employment 13 Appointment of radiation workers by a new employer 13 Radiation Occurrences 13 7. RADIATION PROTECTION 14 Basic protection principles 14 Protection of patients 14 Protection of pregnant patients 15 Protection of women of reproductive capacity 15 Protection of paediatric patients 15 Protection of non-radiation personnel and public 16 Protection of persons holding patients 16 8. PREMISES REQUIREMENTS 17

9 RADIATION WARNING SIGNS, NOTICES AND LIGHTS 17 10. ANNEXURE A 18 11. CONTACT DETAILS 19 12. REFERENCES 20 3

1. INTRODUCTION This Code sets out requirements and recommendations for radiation safety associated with the use of medical diagnostic x-ray equipment. The Hazardous Substances Act, 1973 (Act 15 of 1973) and Regulations (No R1332 of 3 August 1973) govern the safe use of medical x-ray equipment in South Africa. Requirements from the Act and Regulations are incorporated in this Code. Further requirements are taken from source material listed in the section of References. Whenever compliance with a requirement in this Code is mandated the word must / shall is used. The word should indicate a practice that is recommended but not mandatory at this stage. Where a given technology or practice is not specifically covered by this Code, guidance in matters of radiation protection should be sought from the Department of Health: Radiation Control. The Licensee shall be responsible for ensuring that corrective action takes place on items of non-compliance with this Code. The Act does not allow any person to use radiation equipment unless he/she holds a licence under the Act for that purpose. This Code does not cover the use of x-rays for dental and veterinary diagnosis. This Code must be read in conjunction with DOH Guideline documents as listed in Annexure A of this Code. All forms and guidelines are available at:http://www.doh.gov.za/department/radiation/01.html Licensing.DOH Guideline documents: http://www.doh.gov.za/department/radiation/01.html Codes of Practice Electronic products Ionising Radiation

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2. ABBREVIATIONSACT Hazardous Substances Act, 1973 (Act 15 of 1973) DOH Department of Health HPCSA Health Professions Council of South Africa IER Individual Equipment Record mSv milliSievert TLD Thermo Luminescent Dosimeter NTP Nuclear Technology Products PRMD Personal Radiation Monitoring Device SABS South African Bureau of Standards SANAS South African National Accreditation System SDR Supplementary Diagnostic Radiographer QA Quality Assurance QC Quality Control

DEFINITIONSActinic marking Permanent transfer of patient data / identification on to the film prior to processing ALARA As Low As Reasonably Achievable Controlled area A controlled area is a limited access area in which the occupational exposure of personnel to radiation is under the supervision of an individual in charge of radiation protection. This implies that access, occupancy and working conditions are controlled for radiation protection purposes Department Department of Health Diagnostic QC Requirements for licence holders with respect to Quality Control Test for diagnostic x-ray imaging systems 5 Inspection Bodies An organisation approved by the Department of Health to perform acceptance and QC tests on diagnostic x-ray equipment Radiation worker Any person who is potentially exposed as a result of his/her occupation to more than three tenths of the occupational dose limit Regulations Regulations relating to the Control of Electronic Products (No R1332 of 3 August 1973) X-ray unit An electronic product that is designed, manufactured or assembled with the primary purpose of producing x-rays 6

3. LICENSING3.1 The Regulations concerning to the Control of Electronic Products require that a joint product and premises licence be obtained for x-ray equipment before it may be installed and commissioned. (a) Licences are not transferable and are issued: To a specific person or institution;

for specific equipment and its application, and for a specific premises. (b) Licences are issued subject to the Regulations concerning to the Control of Electronic Products and the application of specific conditions. (c) Licence holders must verify the accuracy of the information displayed on the licence issued and communicate any inaccuracies to the DOH.

Application for licences (Form RC001)3.2 It is the responsibility of the prospective user of an x-ray unit to apply for a licence by completing and submitting an application form. Accurately completed forms will ensure processing of the applications without undue delay. The import / manufacture licence number and technical information required on the form must be obtained from the supplier / distributor of the x-ray unit. Allow 30 days for processing of applications.

Installations3.3 The installation of an x-ray unit may only commence after a licence to install the unit has been issued.

Acceptance tests(Refer to Diagnost QC document on DOH website see Annexure A.1) 3.4 Only Inspection Bodies approved by DOH may perform acceptance tests on x-ray equipment. A list of approved Inspection Bodies and scope of the licences are available on the DOH website. 3.5 New Units When a new unit is installed, acceptance tests must be performed by the supplier of the x-ray unit and the results recorded on the prescribed form and filed in the IER of the unit. 3.6 Pre-owned units The prospective user must ensure that acceptance tests are performed. Granting of a licence to use a unit is subject to submission of the results of the tests to DOH. When an existing licenced unit is moved to a new premises (building) or room, prior to use, acceptance tests must be performed on the unit and the results submitted to DOH. 7

Disposal / modification of x-ray equipment (Form RC002)3.7 The licence holder must apply for and obtain permission from DOH by submitting a

completed form RC002 prior to cancellation, modification, disposal and/or sale of x-ray equipment. Particulars regarding the type of disposal, e.g. sale, dismantling, disappearance or storage of a unit, must be furnished to DOH before the cancellation of the licence will be effected.

New / modified premises (Form RC002)3.8 The licence holder must apply for and obtain permission prior to: (a) modification of any licensed premises or layout of equipment on such premises, and/or (b) change of licensed premises (building) or equipment moved to other rooms within the same building.

Responsible person3.9 The licence holder must appoint a responsible person that has adequate knowledge and experience in the field of radiation protection in general. The appointed person is responsible to the licence holder for the safe use of the x-ray equipment (see also par 4). 3.10 The person appointed must be qualified in either of the following categories and registered with the Health Professions Council of South Africa (HPCSA): Radiography; Radiology; Medical Physics, or Chiropractics. 3.11 The responsible person must be appointed in writing indicating the scope of the actions delegated by the licence holder.

Change of responsible person (Form RC002)3.12 The licence holder must notify DOH of a change in responsible person by submitting a completed form RC002. 8

4. RESPONSIBILITIES OF LICENCE HOLDERS / RESPONSIBLE PERSONS4.1 The licence holder of a diagnostic x-ray facility is ultimately responsible for: (a) The entire scope of radiation safety, for the equipment and premises for which he/she holds a licence; (b) fulfilment of all related statutory requirements, and (c) compliance to conditions specified in the licence. 4.2 The licence holder / responsible person must ensure that:

The equipment and the facilities, in which such equipment is installed and used, meet all applicable radiation safety standards; The equipment is maintained and functions properly; The equipment is used and maintained only by competent and appropriately trained persons / personnel; Applicable Quality Control (QC) tests are performed at the prescribed frequencies as stipulated in Diagnost QC document on DOH website (see Annexure A1); The required QC equipment is provided; Ensure that radiation surveys to monitor safe performance of equipment and to monitor radiation levels in work areas are undertaken; Radiation workers (occupationally exposed persons) are identified and issued with personal radiation monitoring devices (PRMDs); The appropriate protective clothing, devices and equipment is provided to personnel and properly used; Radiation safety rules are communicated to and followed by all personnel; Operational procedures are established and maintained to ensure that the radiation exposure to workers, patients and public is kept as low as reasonable achievable (ALARA) without compromising the diagnostic efficiency of the result, and Workers are educated in the hazards and risks of ionising radiation.

Keeping of patient records4.3 Records must be kept and available for inspection purposes by DOH. 4.4 A record / register must be kept of all patients undergoing x-ray examinations. The record / register must be preserved for 5 years and contain the following information: surname, name, date of birth or ID number / age and gender; date of examination; brief clinical indication of the examination; type of examination; number of exposures (repeat exposures included) and fluoroscopy time, dose results (if available) and the name of the person performing the fluoroscopy procedure. 9

Keeping of equipment records4.5 IER must be kept and contain all required information as stipulated in Diagnost QC document on DOH website - see Annexure A.1. 4.6 Radiation worker record (see par 6.3)

Submission of acceptance tests results to DOH4.7 Acceptance test results of pre-owned of x-ray units must be submitted to DOH

following installation (see par 3.6). 10

5. OPERATORS5.1 Only the following persons who are appropriately trained and registered with the HPCSA in Radiography and Radiology, may operate x-ray equipment and perform examinations within their appropriate scope of practice: Radiographer Supplementary Diagnostic Radiographer (SDR): - May only work in a Government hospital / or an institution operated or subsidised by government or provincial authority or by the South African Chamber of Mines (Refer to Medical, Dental and Supplementary Health Services Professions Act, 1974 (Act no 56 of 1974) Annexure 7) - Supplementary diagnostic radiographers must be supervised, at least once a week, by a qualified registered radiographer Chiropractor Radiologist

Operators of mammography units5.2 With effect from 1 July 2009 mammography examinations shall only be performed by qualified radiographers in possession of a recognised additional qualification (post graduate) in mammography. Details of accredited courses can be obtained from the Professional Board for Radiography and Clinical Technology at the HPCSA. 11

6. RADIATION WORKERS6.1 Dose limits for radiation workers and publicApplication Occupational Public Effective dose 20 mSv per annum, not more than 100 mSv over a periods of 5 years (not more than 50 mSv in any one year) 1 mSv per annum Annual equivalent dose to the lens of the eye 150 mSv 15 mSv skin 500 mSv 50 mSv hands and feet 500 mSv --------

6.2 A radiation worker must be older than 18 years. However, if a radiation worker in training is younger than 18, but older than 16, such worker must work under direct supervision. 6.3 The holder of the licence must keep records of the following for a period of 10 years for each radiation worker:

(a) The monthly dose reports furnished by the monitoring service provider(s) (SABS / NTP) and (b) results of medical examinations. (c) RC008 forms (see par 6.5, 6.8 & 6.9)

Pregnant radiation workers6.4 When pregnancy has been diagnosed the women shall not be allowed to work under working conditions where the maximum equivalent dose limit of 2 mSv to the women's abdomen (lower trunk) for the remainder of the pregnancy could be exceeded. Pregnant radiographers shall continue to be monitored in the prescribed manner. Taking into account the specific working conditions, pregnant radiographers must be issued with a direct reading pocket alarm dosimeter, and in so doing prevent that such women are unwittingly exposed to radiation. The employer should provide continuous education as to the risks to the foetus and actual dose levels in the various working environments. Radiation workers, especially young females, must at all time and not only when pregnant, be well versed in the uses of ionisation radiation. (Refer to Guideline document on DOH website Annexure A.2) 6.5 Appointment of radiation workers (Form RC008) (a) A form RC008 (only parts A, C and D) must be completed for each radiation worker. 12 (b) The completed form RC008 must be kept in the licence holders register. Note: Licence holders are no longer required to submit form RC008 or inform DOH of any change in the register as stipulated in Regulation III.4 (b) & (c). 6.6 Medical examinations of radiation workers (a) Before any person is appointed as a radiation worker, he/she must undergo a medical examination. (b) Medical examinations for radiation workers should follow general occupational medical practice for determining fitness for work. (c) Each radiation worker will be required to undergo a medical examination in the event of the following: When a radiation occurrence / incident resulting in an abnormally high dose, is suspected to have taken place or has been confirmed; when a medical practitioner deems it necessary; when such an examination is considered necessary either by the regulatory authority or the holder of the licence and when the radiation worker suspects that his/her health has been, or will be

adversely affected by occupational factors. Note: Annual medical examinations are no longer required by DOH but it remains the prerogative of the licence holder should he/she deems it necessary. 6.7 Monitoring of radiation workers (a) The licence holder must ensure that all radiation workers are issued with a personal radiation monitoring device (PRMD) For correct positioning of the PRMD refer to guideline document on DOH website see Annexure A.3 (b) Application forms for a PRMD can be obtained directly from the following current monitoring service providers: NTP Radioisotopes (Pty) Ltd SABS Holdings (Pty) Ltd Commercial Section Radiation Protection Services 012-3055129 ( ) 012-4286493 ( ) 012-3055137 (Fax) 012-4286685 (fax) [email protected] [email protected] (c) The service provider will forward the radiation dose records to the licence holder on a monthly basis or after a radiation occurrence. The dose records must be kept for 10 years. (d) The licence holder must ensure that the service provider replaces PRMDs at regular intervals not exceeding 32 days. 13 6.8 Termination of employment as a radiation worker (a) When the employment of a radiation worker is terminated the licence holder must ensure that the form RC008 (only parts A, B & D) is completed in duplicate. (b) The form RC008 must be preserved in the licence holders register and the a copy given to the worker in question. (c) The records must be preserved for a period of 10 years from the date of the last entry. Note: Licence holders are no longer required to inform the DOH of any change in the register as stipulated in Regulation III.4 c. 6.9 Appointment of radiation workers by a new employer (a) The licence holder must obtain the form RC008, completed by the previous employer, from the radiation worker. (b) The procedure outlined in paragraphs 6.5, 6.6 & 6.7 must then be followed. 6.10 Radiation occurrences (Form RC010) (a) Details of any radiation occurrence or suspected radiation occurrence must immediately be reported to the Director: Radiation Control on form RC010. 14

7. RADIATION PROTECTIONBasic radiation protection principles are based on: The justification of the practice No radiation examination shall be adopted unless the benefit is outweighed by the associated risk. The optimisation of protection

Radiation doses from medical exposures and those received by the public and occupationally exposed persons must be kept as low as reasonable achievable (ALARA), economic and social factors taken into account. Limitation of individual dose and risk All medical applications of ionising radiation must be managed in such a way that radiation doses to occupationally exposed person and members of the public do not exceed the specified dose limits (see par 6.1). 7.1 Protection of patients (a) All medical exposures should be subject to the principles of justification and optimisation. (b) X-ray examinations shall not be performed unless there are valid clinical indications. (c) Examinations on children shall require a higher justification since such patients may be more sensitive to radiation. (d) Obtain previous x-ray images to minimise the taking of repeat films. (e) Screening programmes of asymptomatic persons shall not be instituted unless approved by DOH. (f) Licence holders should be aware of the approximate patient radiation doses. Reference dose levels should be introduced for applications in diagnostic x-ray examinations as performed in their facilities. (g) When appropriate consider other modalities such as MRI or ultrasound which do not use ionising radiation. (h) Examinations with potential high patient doses such as CT examinations should only be carried out after a proper clinical justification by the radiologist. (i) For each projection select the highest kilovoltage (KV) and fastest film-screen combination compatible with the image quality requirements of the examination. (j) The primary beam shall be collimated at all times. 15 (k) Means to permanently transfer patient identification, prior to processing of the images, must be provided. (l) Radiation examinations may only be requested by: A medical practitioner or any appropriately trained and registered health professional. (Refer to the Guideline document on DOH website Annexure A.4) 7.2 Protection of pregnant patients (a) X-ray examinations must be justified and only essential views performed. (b) Alternative imaging modalities, especially ultrasound for obstetric procedures, shall be used where appropriate. An x-ray examination shall not be performed to assess foetal development where ultrasound facilities are available. (c) X-ray pelvimetry shall not be performed on a routine basis. (d) For examinations where the primary beam unavoidably irradiates the foetus, the methods of minimising dose shall be used as appropriate, and particular attention shall be given to:

minimising the number of views; strict beam collimation; using higher kVp settings; using fast image recording media ; where practicable, using PA projections in preference to AP projections. 7.3 Protection of women of reproductive capacity (a) X-ray examinations involving the exposure of the abdomen of women likely to be pregnant shall be avoided unless there are strong clinical indications for the examination. (b) In order to minimise the possibility of unintentional exposure to the embryo / foetus, notices must be posted at several places within the radiology facility. The notices shall contain wording similar to or having the same meaning as the following: If you might be pregnant notify the radiographer before your x-ray examination. 7.4 Protection of paediatric patients The longer life expectancy of children results in greater potential for the manifestation of possible harmful effects of radiation. In addition to the requirements in this Code for patients in general (see par 7.1), the following requirements for paediatric x-ray examinations shall be observed: (a) For a given procedure each view shall be examined, where practical, before deciding whether to take a further view; (b) fluoroscopy shall in general be used only when radiography will not provide the information required and (c) there shall be strong justification for x-ray procedures involving high doses such as CT (Refer to Guideline document on DOH website see Annexure A.5). 16 7.5 Protection of non-radiation personnel and members of the public (a) Members of the public are not allowed to enter controlled areas unsupervised. (b) Non-radiation personnel or members of the public shall not remain in the xray room during any x-ray procedure unless they are required to be in attendance. (c) The occasional use of nonradiation personnel to give assistance, particularly in ward or theatre radiography, is acceptable but shall involve the full use of protective clothing, devices and techniques to minimise personnel dose. Care shall be taken to ensure that the same non-radiation personnel are not always involved. Women who are pregnant shall not be used in this role. 7.6 Protection of persons holding patients or image receptors (a) No person shall hold a patient, x-ray film cassette, or other imaging equipment or x-ray tube head in position during exposures unless it is otherwise impossible to obtain a diagnostically useful image and not merely that it is a matter of convenience. (b) Holding of patients or x-ray film cassettes during exposure shall be done by

persons accompanying the patient in preference to non-radiation personnel; and by non-radiation personnel in preference to radiation workers. Nonradiation personnel should be chosen on the basis of a roster, i.e. it shall not be the same person who does the holding. No pregnant women or young persons (under the age of 18) shall do any holding. (c) Any persons holding patients or film cassettes in position during an x-ray examination shall wear a lead rubber apron and wherever practicable, lead rubber gloves. No part of the holders body shall be in the primary beam, even if covered with protective clothing. 17

8. PREMISES REQUIREMENTSRefer to guideline document on DOH website: General Guidelines with regard to the design of x-ray rooms (See Annexure A.6)

9. RADIATION WARNING SIGNS, NOTICES AND LIGHTS AT ENTRANCES TO X-RAY ROOMS9.1 Appropriate radiation warning signs and notices must be displayed and required warning lights in working order: (a) Fixed units: A radiation warning sign and warning notice, X-RAYS - NO UNAUTHORISED ENTRY must be displayed at all entrances leading to the rooms where X-ray units are installed. (b) Mobile units: A radiation warning sign and warning notice, X-RAYS - NO UNAUTHORISED USE must be displayed on the control panel of the X-ray units. (c) Warning lights for CT & Fluoroscopy units (excluding theatres): A red warning light, which is only activated when the beam is on and when fluoroscopy is in progress, must be mounted in a conspicuous place outside the entrance to the x-ray rooms. (Refer to Guideline document on DOH website see Annexure A.7) 18

10. ANNEXURE A1. Diagnost QC Requirements for licence holders with respect to Quality Control tests for diagnostic x-ray imaging systems. 2. Management of pregnant radiographers and other staff members. 3. Personnel monitoring when a lead rubber apron is worn medical and veterinary use of x-ray equipment. 4. Request for medical examinations. 5. FDA Public Health Notification: Reducing radiation risk from computed tomography for paediatric and small adult patients 2 November 2001.

6. General guidelines with regard to the design of x-ray rooms. 7. Display and format of radiation warning signs at entrances to rooms containing x-ray units. 19

11. CONTACT DETAILSOffices Postal address Street address Tel & Fax Head OfficeBellville

Private Bag X62 Bellville 7535 c/o Kort & Vrede Str 2nd Floor Louwville Place Bellville 7530 021-9486162 021-9461589 Regional OfficePretoria

PO Box 977 Pretoria 0001 5th Floor MBA Building 527 Church Street Pretoria 0002 012-3416322 012-3411651 Regional OfficeDurban

PO Box 4301 Durban 4000 6th Floor, Room 604 85 On Field Building Field Street Durban 4001 031-3072111 031-3076099 WEB ADDRESS: http://www.doh.gov.za/department/radiation/01.html 20

12. REFERENCES1. Australian Government. Australian Radiation Protection and Nuclear Safety

Agency, 2008. Radiation Protection in Medical Applications of Ionizing Radiation. Publication No. 14. http://www.arpansa.gov.au 2. International Commission on Radiological Protection, 1991. 1990 Recommendations of the International Commission on Radiological Protection. ICRP Publication 60 Vol 21/1-3. Pergamon Press. http://www.icrp.org 3. International Commission on Radiological Protection, 2000. Pregnancy and Medical Radiation. ICRP Publication 84 vol 30/1. Pergamon Press. http://www.icrp.org 4. New Zealand Ministry of Health, National Radiation Laboratory, 1994. Code of Safe Practice for the use of x-rays in Medical Diagnosis. NRL C5. http://nrl.moh.govt.nz 5. South Africa, 1973. Hazardous Substances Act, 1973 (Act of 15 of 1973). http://www.doh.gov.za/department/radiation/01.html Act & Regulations 6. South Africa, 1973. Regulations Concerning the Control of Electronic Products. Regulation Gazette No 3991. http://www.doh.gov.za/department/radiation/01.html Act & Regulations

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International Journal for Quality in Health Care 2:213218 (1990) 1990 International Society for Quality in Health Care

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QUALITY ASSURANCE IN DIAGNOSTIC RADIOLOGYFOR ITS OWN SAKE OR THAT OF THE PATIENTE. T. HenshawIntegrated Radiological Services Limited ,RPS Centre 42 Rodney Street, Liverpool L1 9AA, UK

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X-Ray departments are expensive to equip and Scopus Links run. This paper illustrates how a quality Citing Articles via CrossRef assurance programme may help to limit the wastage of resources. The production of good Google Scholar quality medical X-ray images is extremely complex and can only be guaranteed by Articles by Henshaw, E. T. implementing some form of quality assurance Search for Related Content programme. The exposure of patients to X-rays also entails a risk of radiation injury and a PubMed quality assurance programme is necessary in order to limit this risk to a level as low as reasonably practicable. Because of this, in Articles by Henshaw, E. T. countries within the CEC, legislation now requires such a programme to be implemented. Social Bookmarking The aims of a QA programme are defined, and the implications arising from these aims are discussed. The role of international What's this? organisations in helping to achieve these aims is also discussed. The pitfalls of a QA programme in radiology are also identified particularly: (1) the tendency to carry out a large programme and acquire a considerable amount of data so that the original aims are obscured; (2) the possibility of carrying out tests which are expensive to perform and are not cost effective and (3) the failure to adapt constantly the content of the QA programme to the ever changing needs of the local department and the radiological community

generally. The various components of a QA programme are presented together with illustrations of their possible impact on the standard of work of the X-ray department. These include: (1) resource management through film reject analysis; (2) patient dose measurements; (3) equipment inspection programme; (4) equipment maintenance programme; (5) training and education of staff. Indications are given of the potential savings derived from a QA programme together with approximate estimates of the cost of operating such a programme. Keywords: Quality assurance, radiology, cost effectiveness, dosimetry, equipment maintenance, training, resource management Accepted for publication June 16, 1990.

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X Ray Department Quality Assurance ProgramsRecent governmental regulations for required maintenance and repair of x-ray equipment have become much more stringent. For example, facilities in the State of Maryland are now required to have annual maintenance on their x-ray equipment performed by a service provider registered with the State of Maryland. Fines will be assessed on facilities failing to have this annual maintenance. In addition, the State of Marylands new policy on periodic inspections is as follows: If any violations are cited at a facility, even if they are corrected, the facility will receive a monetary penalty. Under prior Maryland regulations, a fine

would not normally be imposed if required repairs were completed within a 10-day grace period. For more information on the new Maryland regulations please read this article by Steve M. Deaver B.S., R.T. Some service providers consider annual maintenance to consist of taking a few exposures, lubricating moving parts, checking connections, and other fairly simple tasks. Our annual maintenance includes a great deal more. When we are finished, you will receive a sevenpage report of the work done, test results, recommendations and comments.

The following is a partial list of the work that Omni Imaging will perform, in addition to the routine work done by others:Administrative/Facility Documentationy y y

Check for an adequate technique chart Check for technique factors indicated at the control panel Check log of human holders

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Processor transit time Processor temperatures Check for proper service log Fog test for the darkroom

These are just a few of the checks that we perform during our Quality Assurance check up. At Omni Imaging we help our clients maintain their equipment to the high standards that your patients deserve. Our service engineers work in Maryland, Pennsylvania, Northern Virginia, Washington D.C., Delaware and parts of West Virginia.

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Diagnostic X-Ray Imaging Quality Assurance: An Overview PART II Hospital Diagnostic Imaging Quality Assurance Program Review

Survey WorksheetsFacility: Address: Radiology Manager: QC Technologist: QA Co-ordinator: Reviewer: Date:

Abbreviations: (D) Daily (W) Weekly (SM) Semi-Monthly(M) Monthly (Q) Quarterly (SA) Semi-Annually (A) Annually (N) Never (H) High (M) Medium (L) Low (N) NoneContents 1. Hospital and radiology Department Quality 7. Equipment Performance Records and Record Keeping Assurance Committees 1.1 Hospital QA Committee 8. Equipment Appraisal and Replacement Policy 1.2 Radiology Department QA Committee 9. Standardization of Exposure 2. Quality Assurance Training 9.1 Radiographic Positioning 3. Equipment Specification Writing 9.2 Loading factors 4. Quality Control Testing 9.3 Entrance-Skin-Exposure 5. Equipment Acceptance Testing 10. Acceptance criteria for Diagnostic Radigrams 6. Quality Control Testing 11. Reject-Repeat Analysis Program 6.1 X-Ray Equipment QC 12. Summary of Quality Assurance and Quality 6.2 Photographic Equipment QC Control Document Assessment

2 1. Hospital and Radiology Department QA Committees1.1. Hospital Quality Assurance Committee (QAC) 1. Does the hospital have a QAC? ................................................................................................ Y/N 2. Does the hospital have documented QA program? .................................................................... Y/N 3. Is a copy of the hospital organization available (showing level of responsibility and reporting order)? ......................................................................................... Y/N Comments:

1.2. Radiology Department Quality Assurance Committee 1. Does the radiology department have a QAC? ........................................................................... Y/N 2. Does the radiology department QAC have an overall strategy with clearly defined work plans?........................................................................................................................... Y/N 3. Does the radiology department have a documented QA program? ............................................. Y/N If yes, is a copy of the QA manual available? ........................................................................... Y/N 4. Radiology QAC members: Radiology administrator: Medical physicist: Chief x-ray technologist: Quality control technologist: Hospital service engineer: Private consultants: Others: Comments:

35. Radiology department QA program review and reporting structure: Who reviews the radiology QA program? Review schedule: .................................................................................(M) (Q) (SA) (A) (N) Is a summary of the radiology QAC audit plan available? ................................................ Y/N Describe the radiology QAC program reporting structure: 6. Is a copy of the radiology department's organization chart available (showing the level of responsibility and reporting order)? ....................................................................... Y/N 7. Does the radiology QAC serve as an advising committee to give direction, training and/or advice on QA and QC protocols to other hospitals?..................(M) (Q) (SA) (A) (N) If yes, which hospitals? 8. Is a member of the department's QAC on the hospital QAC? : .................................................... Y/N Comments: 2. Quality Assurance Training 1. Is QA training available? ......................................................................................................... Y/N 2. Type of QA training: In-house: Other hospitals: Outside agency: Special courses: Refresher courses: Other: 3. What priority level is placed on QA training? ..........................................................(H) (M) (L) (N) Comments:

43. Equipment Specification Writing 1. Is the QAC involved in equipment specification writing?........................................................... Y/N 2. Does QC technologist participate in equipment specification writing? ....................................... Y/N 3. Who does equipment specification writing? (QAC?, private consultants?, etc.)

4. Is a copy of documented equipment specification writing guidelines available?......................... Y/N 5. Do equipment specifications include acceptance testing criteria?.............................................. Y/N 6. Is a copy of the equipment specification document sent out for tender for the last x-ray unit purchased by the hospital available? . ................................................... Y/N Comments: 4. Quality Control Test Equipment List 1. Are QC test equipment available? ............................................................................................ Y/N 2. List QC test equipment used: (including manufacturer, model and calibration date): Processing test equipment: Manufacturer Model Calibration Date sensitometer: densitometer: thermometer: stop watch: graduated transparent beaker: darkroom fog test tool: Radiographic test equipment: Manufacturer Model Calibration Date exposure and exposure rate meter: full range of ionization chambers: electronic irradiation time measuring device: electronic x-ray tube voltage measuring device:

5collimator and beam alignment tool: aluminum filters: film screen contact wire mesh: star focal spot patterns: Tomography phantoms: Manufacturer Model Calibration Date tomogram scale: tomogram aperture plate: full range body part phantom: uniform density phantom: resolution phantom: step wedge: Image Intensifier test tools: Manufacturer Model Calibration Date full range of lead (resolution) test patterns: low contrast resolution test tool: high contrast resolution test tool: Video test equipment: Manufacturer Model Calibration Date oscilloscope: scope camera: video waveform monitor: video signal generator: photometer: General purpose test equipment: Manufacturer Model Calibration Date chart recorder: other:

65. Equipment Acceptance Testing

1. Does the QAC have an equipment acceptance testing policy? .................................................... Y/N 2. Who does the equipment acceptance testing (manufacturer, in-house, private consultants)?: 3. Equipment acceptance test results recorded?............................................................................ Y/N 4. Equipment acceptance test results kept for QC base data? ........................................................ Y/N 5. Is a copy of equipment acceptance testing results available? ................................................... Y/N Comments: 6. Quality Control Testing The following are general questions regarding the QC testing program and the QC technologists responsibilities. Further information, about x-ray imaging equipment QC testing, i.e., specific tests, test devices and frequency of testing, is collected based on information from "Radiographic Quality Control, Minimum Standards" from the CAMRT, Appendix A of NCRP Report No.99 and "Diagnostic X-ray Equipment and Facility Survey" of Health Canada publication 94-EHD-184. Questions are listed in a separate survey form. 6.1 X-Ray Equipment Quality Control 1. QC responsibilities (persons in charge and reporting order): Radiology department QC program: QC testing: QC record keeping: QC data evaluation: Equipment control parameter setting: Equipment repair and services decisions:

72. Does the x-ray department have a documented equipment QC test protocol manual? ................. Y/N If yes, is a copy of the equipment QC test protocol manual available?....................................... Y/N Does the manual include QC test protocol for the following equipment? : General radiographic equipment?................................................................................ Y/N Fluoroscopic equipment?............................................................................................ Y/N Special procedures equipment?................................................................................... Y/N Mammographic equipment?........................................................................................ Y/N CT equipment?........................................................................................................... Y/N Mobile fluoroscopic equipment? ................................................................................. Y/N Dedicated procedure equipment? ................................................................................ Y/N Film processors? ........................................................................................................ Y/N Other? : 3. Is the QC testing done by a private consulting agent? .............................................................. Y/N If yes, who? Reporting protocol: Consultant objectives: Radiation safety survey of equipment? Equipment specification writing? Acceptance testing?

QC testing of equipment? Advisor on QA program? Frequency of consultant contract: ............................................................... (M) (SA) (A) (N) Is copy of consultant contract objectives available? ........................................................ Y/N 4. QC technologist available? :.................................................. (Full-time), (Part-time), (Occassional) To whom does the QC technologist report? :

85. Does the QC technologist have a specific QC test schedule? ...................................................... Y/N If yes, how strictly is it followed? QC testing schedule priority level:...........................................................................(H) (M) (L) (N) Is a copy of the equipment QC test schedule available?............................................................. Y/N QC test schedule (time spent): h/d; d/w; w/m Consequences of not meeting the QC schedule: 6. QC technologist responsibility x-ray rooms darkrooms processors radiographic tubes fluoroscopic tubes mobile units mammography units CT units other 7. How much time spent testing equipment (number of tubes, hours/unit)? General radiography? Fluoroscopy? Special procedure equipment? Mammography? CT? General film processors? Dedicated film processors? Other: 8. Does QC technologist have adequate time to carry out QC test required? ................................... Y/N 9. Does QC technologist have adequate time to evaluate results of QC tests performed?................. Y/N 10. Does QC technologist have adequate time to update and maintain QC records?.......................... Y/N 11. Are samples of QC tests records (blanks) available?................................................................. Y/N

912. QC test reporting: To whom are QC test results reported?..................................................................................... Y/N What is the reporting structure? Priority of QC reporting:.........................................................................................(H) (M) (L) (N) Consequences of late reporting: 13. QC testing review activity: Is equipment QC test program audited?..................................................(W) (M) (Q) (SA) (A) (N) Review method of audit: Is a copy of the QC audit plan available? ................................................................................. Y/N Consequences of bad reviews: 14. Is QC testing training available for the QC technologist? ........................................................... Y/N If yes, where? when?

15. Is QC technologist shared with other hospitals? ........................................................................ Y/N If yes, list hospital and days per week: 16. Is the Hospital QC performance compared with other large city hospitals?................................ Y/N If yes, who and frequency: Hospital (M) (Q) (SA) (A) (N) Comments: 6.2. Photographic Equipment Quality Control The following are general questions regarding the photographic QC testing program and the QC technologists responsibilities. Further information, about photographic equipment QC testing, i.e., specific tests, test devices and frequency of testing, is collected based on information from "Radiographic Quality Control, Minimum Standards" from the CAMRT, Appendix A of NCRP Report No.99 and "Diagnostic Xray Equipment and Facility Survey" of Health Canada publication 94-EHD-184. Questions are listed in a separate survey form. 1. Number of automatic processors: 2. Number of dedicated processors: 3. Processor sensitometric evaluation performed?................................................... (D) (W) (SM) (N)

104. Is the developer temperature verified using a thermometer?................................. (D) (W) (SM) (A) 5. Replenishment rates checked? ............................................................................ (D) (W) (SM) (N) 6. Transport time checked? .................................................................................... (D) (W) (SM) (N) 7. Is the manufacturer's time/temperature chart followed? ........................................................... Y/N 8. Are film processors cleaned regularly? ........................................................ (D) (W) (SM) (M) (N) 9. Preventive maintenance program for the processor?................................................................. Y/N 10. Are the cassette screens cleaned regularly? ...................................(D) (W) (SM) (M) (SA) (A) (N) 11. Are screen contact tests done? ........................................................... (W) (SM) (M) (SA) (A) (N) 12. Safelight integrity verified? .......................................................................... (W) (M) (SA) (A) (N) 13. Darkroom fog test?...................................................................................... (W) (M) (SA) (A) (N) Comments: 1. Does the radiology department have a silver recovery program?............................................... Y/N 2. Who is in charge of the silver recovery program? 3. Is silver recovery done for all automatic processors? ............................................................... Y/N 4. Does the hospital have a policy on effluent disposal? ............................................................... Y/N

5. Are the developer and fixer treated before going to effluent...................................................... Y/N 6. What happens to old or reject-repeat radiograms? Comments: 7. Equipment Performance Records and Record Keeping 1. Are equipment performance records kept? ............................................................................... Y/N 2. Do the equipment performance records include acceptance testing results?............................... Y/N 3. Are the initial and current radiation safety surveys reports available?....................................... Y/N 4. Are the current year QC tests and results recorded?.................................................................. Y/N 5. Are the past year QC tests and results recorded? ...................................................................... Y/N 6. Are the equipment repairs and servicing recorded (frequency and costs)? ................................. Y/N 7. Is the equipment down time recorded? ..................................................................................... Y/N

118. Is a copy of the equipment performance record available? ....................................................... Y/N Comments: 8. Equipment Appraisal and Replacement Policy 1. Does the QAC have an equipment appraisal and replacement policy? ........................................ Y/N 2. Planned budget allocations for future purchases?..................................................................... Y/N 3 Describe the equipment appraisal and replacement policy budget strategy: 4. Is a copy of the equipment appraisal and replacement policy available ..................................... Y/N 9. Standardization of Exposure 9.1. Radiographic Positioning 1. Is a standard radiographic positioning manual available in each room? .................................... Y/N If no, is it easily accessible? .................................................................................................... Y/N Is a copy (sample) of radiographic positioning manual available? ............................................ Y/N Comments: 2. Current condition of the radiographic positioning manual (indicate on a scale of 1 to 5): 12345 Poor - - - Good Disorganized - - - Tidy Ambiguous - - - Clear Vague - - - Precise Incomplete - - - Comprehensive Neglected - - - Updated Comments: 3. Does the radiographic positioning manual provide instructions about: body part to be x-rayed?.......................................................................................... Y/N number of projections required?............................................................................... Y/N size of image receptor to use? .................................................................................. Y/N

12part rotation? .......................................................................................................... Y/N tube angle?.............................................................................................................. Y/N central ray location? ................................................................................................ Y/N source-to-image receptor distance? .......................................................................... Y/N detail of structures to be shown?.............................................................................. Y/N general instructions for positioning?......................................................................... Y/N illustrations? ........................................................................................................... Y/N Comments: 4. Radiographic positioning manual update: Is the radiographic positioning manual updated?...................................................................... Y/N Who authorizes changes? Are changes reported through QAC reporting channels?............................................................ Y/N Are changes unreported and adopted?...................................................................................... Y/N Comments: 9.2. Loading Factors 1. Is there a loading factors chart (or manual) posted in each x-ray room? ................................... Y/N Is a copy (sample) of loading factors manual available?........................................................... Y/N 2. Current condition of Loading Factor charts (indicate on a scale of 1 to 5): 12345 Poor - - - Good Disorganized - - - Tidy Ambiguous - - - Clear Careless - - - Precise Incomplete - - - Comprehensive Neglected - - - Updated Comments: 3. Does the loading factors chart contain the following information? : patient thickness?............................................................................................... Y/N

13child/adult technique?......................................................................................... Y/N optimum kVp?.................................................................................................... Y/N optimum time, mA, mAs or automatic exposure control? ..................................... Y/N focal spot size? ................................................................................................... Y/N grid/no grid? ....................................................................................................... Y/N film-screen combination? .................................................................................... Y/N Comments: 4. Is the loading factors chart strictly followed?........................................................................... Y/N If not, why? 5. Loading factors chart changes: Is the loading factors chart updated or changed to compensate for equipment or processor problems? ........................................................................................................... Y/N Who sets the loading factors chart factors? Who authorizes the loading factors chart changes? Are the loading factors chart changes reported to QC technologist?........................................... Y/N Are changes unreported and adopted?...................................................................................... Y/N Comments: 9.3. Entrance-Skin-Exposure (ESE) 1. Are the ESEs measured for:

each diagnostic procedure?........................................................................................ Y/N each x-ray room? ...................................................................................................... Y/N each fluoroscopic procedure?..................................................................................... Y/N each fluoroscopic room?............................................................................................ Y/N List the ESE procedures measured: 2. Is the ESE schedule reviewed : ............................................................................. (M) (SA) (A) (N) 3. Are the ESEs recorded in the QC log book?............................................................................... Y/N

14If yes, 1) is a copy (sample) of the radiographic ESE record for each room available?............. Y/N 2) is a copy (sample) of the fluoroscopic ESE record for each room available? ............. Y/N 4. Is there an ESE comparison with other major city hospitals? If yes, who? How often? (M) (Q) (SA) (A) (N) Comments: 10. Acceptance Criteria for Diagnostic Radiograms 1. Have acceptance criteria for diagnostic radiograms established? .............................................. Y/N 2. Do the acceptance criteria cover the following points: 1) the visibility of predetermined landmarks clearly defined for each view? ............................. Y/N 2) an acceptable density range measured at predetermined anatomical landmarks? .................. Y/N 3) also include three limits of acceptability clearly defined where: a) the x-ray technologist forwards radiogram to radiologist for reporting? ...................... Y/N b) or the x-ray technologist consults with the radiologist? .............................................. Y/N c) or the radiogram is rejected and a repeat is done?....................................................... Y/N 3. Are the acceptance criteria followed by technologist? .............................................................. Y/N 4. Are the acceptance criteria reviewed?...................................................................................... Y/N Frequency of review: ....................................................................................(M) (Q) (SA) (A) (N) 5. Are acceptance criteria compared with that of other major city hospitals? ................................ Y/N 6. If yes, Who?, How often? .............................................................................(M) (Q) (SA) (A) (N) 7. If a QA criteria has not been established against which standard are the radiograms checked when the radiologist is not available? (e.g., evening or weekends) How does that affect the repeat rate when the radiologist does become available?

158. Is a copy of the acceptance criteria available? ......................................................................... Y/N Comments: 11. Reject-Repeat Analysis Program (RRAP) 1. Does the radiology department have a comprehensive RRAP? ................................................... Y/N 2. Is a copy of the documented RRAP parameters available? ......................................................... Y/N 3. Who sets the RRAP parameters? : 4. Reject-Repeat Analysis parameters:

patient positioning patient motion radiograms too dark radiograms too light artifacts tomographic scout radiograms fog static medical reasons processor malfunction mechanical quality control films clear black film Good radiograms Other ___ Total waste Total rejects Total repeats Comments: 5. Do the RRAP results show how many rejects or repeats were acceptable and should not have been repeated? ............................................................................................... Y/N 6. Are the RRAP results posted?................................................................................................... Y/N 7. Is the repeat percentage analysis evaluated: per technologist? per room? ..................................................... Y/N 8. What is the current reject-repeat rate? 9. What is the reject-repeat rate for the last six months? : 10. What corrective action is used to reduce the reject-repeat rate?

1611. Reject-repeat rate is based on what workload? 12. What is radiology department total workload? 13. Is the RRAP compared with other hospitals?............................................................................. Y/N If yes, who? How often?: ..............................................................................(M) (Q) (SA) (A) (N) Note: RRAP should look at three separate categories: 1) Total waste films: all films in the scrap bin? .............................................................. Y/N 2) Total rejects: all films except clear and QC films? ...................................................... Y/N 3) Total repeats: only those where an additional radiogram was made? ........................... Y/N RRAP should not include radiograms from special procedures areas (cardiovascular, neurological copy, nor subtraction films.) Comments: 12. QA/QC Document Assessment (Summary) The following (current) documents should be collected as examples for assessing the Radiology Department's QA/QC program. Section Reference Documents 1.1.3. Hospital organization chart (with reporting order) 1.2.3. Radiology department QA manual 1.2.5. Summary of radiology departments QAC audit plan 1.2.6. Radiology departments organization chart (with reporting order) 3.4. Equipment specification writing guidelines 3.6. Equipment specification document (e.g., last purchase) 4.2. List of all QC test equipment 5.5. Equipment acceptance test results 6.1.2. Equipment QC test protocol manual 6.1.3. QC consultant contract objectives 6.1.5. Equipment QC test schedule 6.1.11. Sample QC test records (blanks)

176.1.13. QC audit plan 7.8. Equipment performance record 8.4. Equipment appraisal replacement policy

9.1.1. Radiographic positioning manual (sample) 9.2.1. Loading factors chart (sample) 9.3.3. ESE (sample list of ESEs recorded and date in QC log for radiographic and fluoroscopic examinations for each room) 10.8. Acceptance criteria for diagnostic radiograms 11.2. Reject-Repeat Analysis Program parameters

http://www.hc-sc.gc.ca/ewh-semt/alt_formats/hecs-sesc/pdf/pubs/radiation/qax_ray_image-aq/qa-x_ray_image-aq-eng.pdf

Guidelines1995/1

NRL Report

for Quality Assurancein Radiation Protectionfor Diagnostic X-Ray Facilities:Large X-Ray Facilities

J L Poletti

GUIDELINES FOR QUALITY ASSURANCE IN RADIATION PROTECTION FOR DIAGNOSTIC X-RAY FACILITIES: LARGE X-RAY FACILITIESNATIONAL RADIATION LABORATORY MINISTRY OF HEALTH CHRISTCHURCH NEW ZEALAND

CONTENTSPage ABSTRACT 1 INTRODUCTION 1 2 IMPORTANT CONCEPTS FOR QA PROGRAMMES 3 3 SPECIFIC REQUIREMENTS FOR LARGE FACILITIES 5 3.1 Automatic film processors 6 3.2 X-ray generators 7 3.3 X-ray tubes 8 3.4 Automatic exposure controls (AEC) 9 3.5 Light beam diaphragms (LBD) 9 3.6 X-ray cassettes 9 3.7 X-ray image intensifier systems 9 3.7.1 Image intensifiers 11 3.7.2 Fluoroscopic television chains 12 3.8 Fast film changers 12 3.9 Cine systems and small format cameras 12 3.10 Digital subtraction imaging (DSI) systems 13 3.11 Computed tomography scanners 14 3.12 Mammography machines 15 3.13 Tomography machines 15 3.14 Mobile radiographic equipment 15 3.15 Mobile image intensifier equipment 16 3.16 Grids 16 3.17 Protective equipment 16 3.18 Darkrooms 16 3.19 Viewboxes 16 3.20 Technique charts 17 3.21 Dose measurements 17 3.22 Approval of the QA programme 17 4 AN OUTLINE QA PROGRAMME FOR LARGE FACILITIES 17 BIBLIOGRAPHY 21 .

ABSTRACTThe Code of safe practice for the use of x-rays in medical diagnosis (NRL C5 ) requires that each x-ray facility has an appropriate quality assurance (QA) programme in radiation protection. The objective of the quality assurance programme is to ensure accurate diagnosis and to ensure that doses are kept as low as reasonably achievable. In addition the quality assurance programme should ensure compliance with NRL C51 at all times. This requires an in-house system of regular checks and procedures. These guidelines are intended to assist x-ray facilities to comply with the NRL C5 requirement, by outlining the features considered to be appropriate for a QA programme. The concepts involved in QA programmes are described, and details are given of the types of tests to be performed. An indication of QA equipment required is given, and suggested test frequencies are outlined.1

1 INTRODUCTIONFor the purposes of these guidelines, a large x-ray facility is defined as having at least one of the following (in addition to general radiography rooms): - More than one fluoroscopy room - More than one film processor - A mammography machine - A digital fluoroscopy system - A CT scanner The use of ionizing radiation in New Zealand is controlled by the Radiation Protection Act (1965). Licences under this Act may be granted for a number of purposes, including medical diagnosis. All licences for the use of x-rays for medical diagnosis include a condition that the requirements of the Code of safe practice for the use of x-rays in medical diagnosis (NRL 1 C5 ) are met. Among the requirements of NRL C5 are a quality assurance programme in radiation protection. The objective of the quality assurance programme is to ensure accurate diagnosis and to ensure that doses are kept as low as reasonably achievable. In addition the quality assurance programme should ensure compliance with NRL C51 at all times. This requires an in-house system of regular checks and procedures as detailed in these guidelines. In addition, and completely independent from the quality assurance programme, each facility is required to have a complete radiation protection survey performed at least once every four years. For those facilities with image intensifier systems, a CT scanner or mammography machine, these must be done every two years. The radiation protection survey is intended to focus on radiation safety and checks for compliance with the appropriate requirements of NRL C5. As part of this, the radiation protection survey acts as an external independent audit of the quality assurance programme. The tests and measurements made during a radiation protection survey cannot be considered to be part of the quality assurance programme. The radiation protection survey is currently performed free of charge to the facility by NRL staff. A qualified health physicist is also permitted to do radiation protection surveys, provided that the protocol and equipment used are acceptable to NRL. A comprehensive radiation protection quality assurance programme requiring some test equipment is appropriate for large facilities (as defined above). The general requirements for a quality assurance programme in radiation protection, as given in NRL C5 and of relevance to large x-ray facilities, are summarised as follows: (Note that should and shall have specified meanings within NRL C5, but not elsewhere in these guidelines.) 1 The principal licensee for any facility that uses x-rays for medical diagnosis shall ensure that a suitable programme of quality assurance (with respect to radiation protection), is instituted and maintained. 1

2 The programme shall ensure as a primary goal, accurate and timely diagnosis. As secondary goals the programme shall ensure minimisation of radiation exposure and risk and of discomfort and cost to patient and community. These secondary goals shall always be balanced against the primary goal. 3 The programme shall comprise such routine checks and procedures as are required to give reasonable confidence in the continuing compliance with this Code of Practice. The programme shall be approved by a qualified health physicist, to ensure that the quality control procedures are sufficient to ensure compliance with this Code. The programme shall include quality control of x-ray film processing facilities. Note: A programme is not to be confused with a radiation protection survey. 4 There shall be a well-defined responsibility and reporting structure, appropriate to the size and scope of the facility. Each staff member shall routinely review the results of checks for which they are responsible and report summary results to their superior. Any anomalous check shall be reported immediately. Each staff member shall be responsible for the maintenance of the programme by any personnel under his/her control. 5 Procedures should be standardised and set down in protocols or local rules (a quality assurance manual) wherever possible. 6 All equipment shall be checked at suitable regular intervals to ensure it is operating within suitable tolerances of accuracy and consistency. The tests performed and their frequency shall be approved by a qualified health physicist. All measurements and maintenance shall be recorded in an equipment log. As well as routine tests any faults or breakdowns shall be logged and reported to superiors. 7 Acceptance tests shall be performed on all new equipment to (a) ensure that it meets the manufacturer's specifications; (b) ensure that it complies with this Code; (c) establish baseline data for subsequent quality assurance. 8 Control charts shall be established for all parameters measured. Control limits shall be established for all parameters. If a measured value of any parameter exceeds a control limit, action shall be taken to correct the parameter. 9 A retake analysis shall be performed at regular intervals to monitor the effectiveness of the programme. 10 The frequency with which a particular parameter is tested should be determined by both the likelihood and the consequences of an error beyond the acceptable tolerances. 2

11 The programme should conform to the procedures and tolerances given in NCRP report 99 (National Council on Radiation Protection and Measurements, 1988)2 or Assurance of quality in the diagnostic x-ray department3. 12 The programme for CT facilities should include the recommendations given in IEC 12234

2-6 . It should be noted that a properly implemented QA programme will result in significant benefits. These will include reduced costs due to reduced repeat rates, increased accuracy of diagnosis, reduced equipment down-time and increased morale and job satisfaction for staff5,6,7,8.

2 IMPORTANT CONCEPTS FOR QA PROGRAMMESAcceptance testingWhenever a new piece of equipment is installed, acceptance tests should be performed. This may take a few days for complex equipment9. The purposes of the acceptance tests are threefold. - First it is important to check that the equipment meets the specifications set out in the purchase contract with the supplier. (For this reason it is important that purchase contracts clearly state the requirements for the equipment.) - Second, the acceptance tests establish baseline values for the parameters that are to be monitored during the QA programme. - Third, the acceptance tests will show whether the machine complies with the requirements of NRL C5, at installation.

Control chartsOnce baseline values for the QA parameters have been established a system has to be set up to ensure that these parameters are maintained to within acceptable tolerances. Control charts are an essential part of the system7. A control chart is a plot of the measured parameter with time. A typical control chart is shown in figure 1. The control chart has three horizontal lines, giving the desired value of the parameter and the allowable limits. The desired value is determined from the acceptance tests, or from tests made at the start of the QA programme (first ensuring that the equipment is performing correctly). Allowable limits may come from many sources, such as published protocols, regulatory requirements, or the effects on other parameters that may be affected. 3

Figure 1. An example of a control chart1/2/942/2/943/2/944/2/945/2/948/2/949/2/9410/2/9411/2/9412/2/9415/2/9416/2/9417/2/9418/2/9419/2/9422/ 2/9423/2/9424/2/9425/2/9426/2/94889092949698100ValueLower limitUpper limitControl

valueDate

Each time a measurement is made the result is plotted on the control chart. Whenever a parameter goes outside the control limit, the measurement should be repeated. If no mistake has been made and the parameter is still out of control, then immediate action must be taken to correct the parameter. If this is not done, then the entire QA programme is a waste of time. It is sometimes possible to observe trends in the data that suggest that a parameter will become out of control in the near future (as in the example above). It is advisable to take corrective action at this stage, rather than to wait until the parameter is out of control.

Reject/retake analysisA reject is defined as any film rejected by the department as scrap for any reason7,10,11. A retake is a patient film that has to be retaken because of an error. Retakes are only a part of all rejected films. Rejects may be due to three main causes. 1 Retakes 2 Films wasted due to other causes, such as fogging, equipment breakdowns, etc 3 Trial films to establish exposure settings that are not viewed by a radiologist as part of the diagnosis. (For example, some films in a tomo-graphic series.) Analysis of the rejected films over a period of time will enable causes of rejects to be determined and improvements to be made. The more detailed the analysis performed, then the more information will be obtained. The simplest approach is just to collect all rejects and to express the rate as a percentage of all films used. This gives a baseline value for the reject rate for future reference. 4

This may be done continually, or for shorter periods on a regular basis. The minimum period should be at least six weeks. The first two weeks' results are generally discarded to eliminate the "startup effect". If the rejects are sorted by work area or room, then corrective action may be directed to where it is most needed. If they are categorised by reason for rejection, then effort may be directed at reducing the most common errors. Further subdivision by anatomical region may help determine which examinations are causing the most difficulty. Finally, analysis by staff member may be used to direct training to staff with difficulties in particular areas.

Equipment logsEach x-ray room should have an equipment log7. To be recorded in this log are the dates and details of all QA corrective action, breakdowns and routine servicing. This should include, if possible, an estimate of the downtime.

Responsibility for the QA programmeIn every department, a particular person should be assigned the overall responsibility for the QA programme7. Clearly, this person should be familiar with all the x-ray equipment and with the principles of radiology quality assurance. Where appropriate, it is well worthwhile to establish a committee to oversee the programme. This committee should include representatives of all the areas involved, MRTs, radiologists, medical physicists, service personnel and management. (Note that NRL C5 requires that the QA programme be approved by a qualified health physicist or directly by NRL.)

The QA manualThe procedures involved for the entire QA programme must be recorded in a manual12. This is to ensure that all tests are carried out in a consistent and reproducible manner. If not, then parameters may appear to be out of control, where in fact the change was due to differences in the measurement technique. Clearly the manual should be readily available to all personnel concerned.

Staff trainingAt the start of the QA programme, staff will need to be given sufficient training to carry out the QA procedures for which they are responsible. Periodic refresher training will be required also during the programme to keep staff up to date with development of the programme and to provide feedback on its effectiveness and acceptability to staff.

3 SPECIFIC REQUIREMENTS FOR LARGE FACILITIESAll equipment and accessories need to be included in the QA programme, although the frequencies may be very different for each item. This chapter describes the parameters that need to be tested for each item of equipment and gives the suggested frequency of tests. Where appropriate, recommendations for 5

test equipment are given. Specific step-by-step descriptions and tolerance values of all the tests are not given. Such detailed information may be found in many of the publications listed in the bibliography. In many cases the tolerances required may be determined from the requirements of NRL C5. In any case the qualified health physicist may choose appropriate frequencies where specific guidance is not given elsewhere. Note that QA measurement instruments or systems are available from a number of manufacturers. These generally combine kVp, dose and time measurement capabilities, and in some cases are computer interfaced and have QA reporting software. The cost of such instrumentation is small compared to the cost of the x-ray equipment and is well justified. It is essential that all test equipment be calibrated on a regular basis. NRL may be consulted if necessary for details of equipment calibration.

3.1 Automatic film processorsOf all equipment in x-ray departments, film processors cause the greatest proportion of rejects7,10,13,14. Consequently, QA of film processors will give the greatest improvement in reject rate. Therefore, film processor QA should be the first priority of any QA programme and will probably form a major share of the work of the programme. Processor QA must be performed daily to be fully effective. The principles of processor QA are simple and well described in many documents2,3,15,16,17,18,19,20. The first step is to ensure that the processor is operating correctly at the start of the programme, usually by cleaning, replacing chemicals and checking the replenishment rates and developer temperature. A light sensitometer should then be used daily to expose test films that are processed without delay20,21. Measurements of the densities with a densitometer are then made to give base+fog, mid density (speed) and contrast indexes which are plotted on the control charts. Systems that automate much of this procedure are commercially available. (Note that special measures are required for modern low-crossover films, or films with different emulsion speeds on each side.) If any parameter is found to be out of control, corrective action must be taken. The appropriate action may often be determined by consulting trouble-shooting charts. (Charts are generally supplied by x-ray film or film processor manufacturers.) These show the action to be taken, for example, if contrast and speed are down but fog is up. Control charts and test films should be stored for future reference, and a log book should be kept for each processor. Two further items are important for processor QA. The first is that the test films must always come from the same box of film, to eliminate variations between film batches. Second, when the box is almost empty, a new box should be started in parallel, to check for differences. It may be necessary to adjust the control chart values if the new batch is slightly different or even to reject the batch of film, if it is too far out of control. (It has happened!) 6

3.2 X-ray generatorsPeak kilovoltageThe most important parameter to monitor is the peak kilovoltage, since small drifts in the kVp can significantly alter the film density. Large x-ray facilities should have some form of kVp instrument. Either an inferential digital kVp meter or an Ardran and Crooks type penetrameter22,23 may be used. Alternatively, a qualified health physicist may be contracted to make kVp and other measurements requiring expensive equipment. Depending on the age and stability of the generator, kVp measurements should be made at least annually, and in addition, after servicing, and if a drift in kVp is suspected for any reason.

Linearity with mA/mAsGood linearity will ensure that the same film blackening can be obtained for the same mAs, regardless of the mA/time combination used. To assess linearity a dosemeter is required7, although results of reduced accuracy may be obtained using film24. Depending on the age and stability of the generator, linearity measurements should be made at least annually, after servicing, and if unpredictable results are being achieved with changes in mA.

Reproducibility of mAsIt is clearly important that the film blackening should always be the same for a given machine setting. Good reproducibility is therefore essential for consistent radiography. Reproducibility may be assessed using a dosemeter7, although results of reduced accuracy may be obtained using film24. The standard deviation should not exceed 5% of the mean dose1.

Exposure timer accuracy and reproducibilityThese contribute to mAs linearity and reproducibility. Many instruments are available with time measurement capabilities, while a spinning top may be used for one- and two-pulse machines7,17.

Waveform monitoringIncreasing numbers of test devices are capable of displaying the x-ray output and/or the kVp waveform. It is strongly recommended that the waveform be checked at a range of generator settings whenever the full set of tests is done25.

Regular x-ray generator testsAll of the above tests for kVp, linearity, reproducibility and exposure timer require the use of test equipment and in many cases will require the services of a qualified health physicist26. Therefore, in order to provide a quick check on the entire radiographic system that is easily performed by radiography staff, it is recommended that a stepwedge exposure test be performed periodically. Although such a test is not likely to be able to provide a diagnosis for any equipment problems, it will show whether there have been any changes since the previous test. The stepwedge exposure frequency should be as determined by a qualified health physicist, depending on the age and stability of the equipment. 7

Weekly tests may be appropriate for older machines, while monthly to quarterly may be more appropriate for modern equipment. The design of a suitable stepwedge is given in figure 2. This may easily be constructed from layers of 2.5 mm aluminium. (NRL may be able to supply suitable wedges should there be sufficient demand.) This should be radiographed using an mAs for which the image of the thickest part of the wedge is just discernible above the base+fog density. For single phase machines with 2.5 to 3.0 mm total filtration, 80 kVp should be used, while for three-phase and medium frequency machines 70 kVp should be used. An 18 x 24 or 24 x 30 cm cassette may be used. (If a higher kVp is typically used for a particular room, then a 1 mm Cu plate added to the wedge may be appropriate.) The cassette, each side of the wedge, must be shielded with lead or lead rubber. The kVp, mAs and FFD required for this should be recorded in the QA manual and should be used for all subsequent tests, unless there is some change to the x-ray machine or film processing. In this case a new mAs should be determined for subsequent tests. The first image should be kept in a safe place and used as a reference image to compare with the subsequent images. While the images may be assessed by eye the use of a densitometer is preferable.End viewSide viewTop view50 mm220 mm3.0 mm AluminiumOptional 1 mm Cu plate

Figure 2. Design for a stepwedge suitable for QA of x-ray machines In the event that the image differs markedly from the reference image, then the reason should be sought. If there has been no change in processing conditions, as determined by the daily processor QA, then there could be a fault in the x-ray machine.

3.3 X-ray tubesFiltrationThe filtration must comply with the NRL1 requirement for greater than 2.5 mm Al equivalent in the primary beam. To measure the total filtration, a set of high purity aluminium filters and a dosemeter are required. The half value layer should be measured at a known kVp and the total filtration inferred from an appropriate 8

chart27. It may be possible to inspect the tube assembly to establish that filtration complies, by adding up the equivalent filtration of each component, plus any added filtration. Filtration needs to be measured at acceptance testing and then only after servicing or modification to the tube assembly.

LabellingNRL C5 requires that the focal spot position be marked, to enable radiation protection survey measurements to be made accurately and consistently. A label is also required, giving the specifications of the tube. This should be checked at acceptance testing and after major servicing.

3.4 Automatic exposure controls (AEC)Significant reductions in the retake rate may be achieved through consistent use of AEC for all exposures28. However, this can only be achieved if the AEC device itself is correctly adjusted and is included in the QA programme. A simple device for streamlining the AEC