radiation protection in nuclear medicine

1. Quality Assurance IAEA Training Material Radiation Protectionin Nuclear Medicine

2. OBJECTIVE To become familiar with the concepts of Quality Assurance in radiation protection in nuclear medicine and procedures for reviewing and assessing the overall effectiveness of radiation protection 3. Content

General principles

Organization of QA

Administrative routines

Occupational and Medical exposure

Instrumentation

Education and training

4. Part 9. Quality Assurance Module 9.1. General principles IAEATrainingMaterialonRadiation Protectionin Nuclear Medicine 5. BSS 2.29. Quality assurance programmes shall be established that provide, as appropriate: a) adequate assurance that the specified requirements relating to protection and safety are satisfied; and ` b) quality control mechanisms and procedures for reviewing and assessing the overall effectiveness of protection and safety. 6. Meaning for medicalexposure that: II.22.Registrants and licensees shall establish a comprehensive quality assurance programme for medical exposures with the participation of appropriate qualified experts in the relevant fields, such as radiophysics or radiopharmacy, taking into account the principles established by the WHO and the PAHO. 7. QA-PROGRAMME OBJECTIVES

Improvement in the quality of the

diagnostic information.

* Use of minimum amount of radionuclide

activity to ensure the production of the

desired diagnostic information.

* Effective use of available resources

8. BSS II.23. Quality assurance programmes for medical exposuresshall include: a) measurements of the physical parameters of the radiation generators, imaging devices and irradiation installations at the time of commissioning and periodically thereafter, b) verification of the appropriate physical and clinical factors used in patient diagnosis or treatment; c) written records of relevant procedures and results d) verification of the appropriate calibration and conditions of operation of dosimetry and monitoring equipment; and e) as far as possible, regular and independent quality audit review of the quality assurance programme for radiotherapy procedures. 9. QUALITY ASSURANCE (definition) all those planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given requirements for quality (ISO) 10. QA and QC

Quality Assurance is the overall process which is supported by Quality Control activities

Quality Control describes the actual mechanisms and procedures by which one can assure quality

11. QUALITY Quality of a practice is to fulfil the expectations and demands from: Patient Clinician Yourself 12. QUALITY ASSURANCE Protection Safety OVERALL QUALITY Diagnostics Therapy 13. QUALITY DEFINE OBJECTIVES How many times should the nurse be allowed to drop the child? What is an acceptable sensitivity and specificity? 14. NUCLEAR MEDICINE SERVICE Primaryservice Secondary service Nuclear medicine examination or treatment facilities patient care waiting time staff reporting competence experience optimisation radiopharmaceuticals methods examination technique instrumentation etc etc 15. QUALITY ASSESSMENT Communication with theclient (patient, clinician). Expectations Acceptable level Reality 16. Clinical problem

RadiopharmaceuticalInstrumentation

Diagnosis and therapy with unsealed sources NUCLEAR MEDICINE 17. QUALITY ASSURANCE PROGRAMME Aquality assurance programme in nuclear medicine should ideally include: Procedure(i.e patient history and signs, diagnostic question, appropriateness of investigation, contraindications) Planning of procedure(i.e reliable administrative procedures, patient information, patient preparation) Clinical procedure(i.e approved suppliers and materials, storage, preparation, clinical environment, patient handling and preparation, equipment performance, acquisition protocols, waste disposal) Training and experienceof nuclear medicine specialists, physicists and technologists and others involved Data analysis(i.e processing protocol, equipment performance, data accuracy and integrity) Report(i.e. data, image review, results and further advice) General outcomes(i.e clinical outcome, radiation dose, patient satisfaction, referring physician satisfaction) Audit 18. Module 9.2. Organization Part 9. Quality Assurance IAEATrainingMaterialonRadiation Protectionin Nuclear Medicine 19. ORGANIZATIONS International bodies Recommendations. Interlaboratory comparison programmes. Education and training. National organizations National guidelines, codes of practice etc. Interlaboratory comparison programmes. Education and training. Industry Assistance in acceptance tests. Documentation. Training. Maintenance. Professional associations Supporting QA-programmes Establishing working groups Education and training 20. LOCAL ORGANIZATION Hospital manager (licensee) QA committee QA-group nuclear medicine (chief technician, physicist, physician, pharmacist) 21. QA Committee Membership

Must represent the many disciplines within the department

Should be chaired by the Head of Department

As a minimum must include a medical doctor, a physicist, a technologist and an engineer responsible for service and maintenance

Must be appointed and supported by senior management

Must have sufficient depth of experience to understand the implications of the process

Must have the authority and access to the resources to instigate and carry out the QA process

22. Quality Assurance Committee

Should represent the department

Should be visible AND accessible to staff

Oversees the entire Quality Assurance program

Writes policies to ensure the quality of patient care

Assists staff in tailoring the program to meet the needs of the Department (using published reports as a guide)

Monitor and audit the program to ensure that each component is being performed and documented

23. Module 9.3. Administrative routines Part 9. Quality Assurance IAEATrainingMaterialonRadiation Protectionin Nuclear Medicine 24. ADMINISTRATIVE ROUTINES Request Patient idand care Computer evaluation Diagnostic report Examination Method 25. REQUEST It is the responsibility of thenuclear medicine specialist that the study requested by the referring physician is justified . Special attention must be paid to studiesrequested for children and pregnant women. Are therealternative methods e.g. ultrasound, MRI etc.? Communication, on a regular basis, between the referring clinician and the nuclear medicine specialist is very important. 26. PATIENT

Identification of the patient

Information about the examination

including premedications

Waiting for the examination

A fully informed and motivated patient is the basis for a successful examination as well as a staff well educated in care of the patient. 27. YOUNG PATIENTS ..should also be informed and motivated 28. PATIENT MOVEMENT 29. PATIENT MOVEMENT moving moving moving 30. Policies and Procedures Manual

Reviewed (typically) yearly

This manual contains clear and concise statements of all the policies and procedures carried out in the department

Updated as procedures change

Policies and Procedures Manual 31. Policies and Procedures Manual

As a minimum, sections should exist for

Administrative procedures

Clinical procedures

Radiation safety

32. Policies and Procedures Manual

It must be signed off by the Head of Department and appropriate section heads

It is important that all staff have ownership to the manual - it should reflect the opinions of all and be agreed to by all

A list of all copies of the Manual and their location must be kept to ensure that each copy is updated

33. METHODS Methods should be in accordance with accepted practices Study name: Bone scan Preparation of patient: Empty bladder Radiopharmaceutical: Tc99m-MDP Route of administration: IV injection Activity: 400 MBq Type of examination: Whole body scan Views: AP, PA Scanning speed: 10 cm/minute Collimator: Scanning Window setting: 140+/-20% keV Positioning of patient: Supine Presentation of result: Images in BW on film.Original and filtered. 34. METHODS Static?Tomographic? Dynamic? 35. METHODS Tl-201Tc-99m 25 mSv8 mSv 36. QUALITY ASSURANCE COMPUTER EVALUATION

Efficient use of computers can

increase the sensitivity and

specificity of an examination.

software based on published and clinically tested methods

well documented algorithms

user manuals

training

software phantoms

Analysis of the programme code

Phantom studies

Simulated examinations

Reference data (normal material)

Clinical evaluation

Q C Application programmes 38. Bone scan phantom 39. Thyroid phantom 40. 41. DIAGNOSTIC REPORT Patient identification Date and type of study Radiopharmaceutical and activity Study results - e.g. a graph or a series of images Objective description of findings Diagnostic conclusion and recommendations Avoid adjectives like possible, probable, likely etc. They can never be interpretated by the referring physician. The diagnostic conclusion should be more quantitative e.g. by using a probability statement. 42. QUALITY ASSURANCE METHOD Patient follow-up. Correlation with other available surgical, pathological, clinical and anatomic information. False positives? False negatives? 43. Society of Nuclear Medicine Procedure Guideline for General Imaging The final judge of any analytical method is a clinical audit: the correctness and impact of the decisions made with respect to any method and process. 44. RECORDS

Authorization certificate and documentation supporting the corresponding application, and also any correspondence between the licensee and Regulatory Authority;

Name of the person authorizedand responsible for the RPP;

Individual doses (current and prior work history);

Results of area surveys;

Equipment and instrument QC tests and calibration;

Inventory of unsealed and sealed sources;

Incident and accident investigation reports;

Audits and reviews of the radiation safety programme;

Installation, maintenance and repair work;

Facility modification;

45. RECORDS (cont)

Training provided (initial and continuing), including the following information:

Name of the person(s) who delivered the instruction ortraining;

Name of the person(s) who received the instruction ortraining;

Date and duration of the instruction or training;

List of the topics addressed; and

Copy of the certificates of training.

Evidence of health surveillance of workers;

Waste disposal ;

Transportation:

Package documentation;

Package surveys;

Transfer/receipt documents; and

Details of shipments dispatched

Patient records; and

Patient discharge surveys for patients receiving radionuclide therapy.

46. Module 9.4. Occupational and medical exposure Part 9. Quality Assurance IAEATrainingMaterialonRadiation Protectionin Nuclear Medicine 47. EXAMINATION Request Patient idand care Computer Evaluation Diagnostic report Examination Method 48. Patient The patient shall always be confident that a nuclear medicine examination and therapy is performed correctly and with highest possible quality regarding both diagnostics/therapy and safety. 49. Medical exposure

Choice of examination

Determination of technical parameters

Optimization of administered activity

Methods of reducing the absorbed dose

Quality control of equipment and radiopharmaceutical

Quality assurance of methods

Safe routines to avoid misadministration

50. Factors affecting medical and occupational exposure Receipt and storage Preparation Contamination Radioactive waste Detection (QC equipment) Administration 51. QUALITY CONTROL RADIOPHARMACEUTICALS

Radionuclide purity (other radionuclides?)

Radiochemical purity (labelling efficiency)

Chemical purity (toxic substances?)

Sterility

Absence of pyrogens

Responsibility of the approved manufacturer and supplier 52. QUALITY ASSURANCE RADIOPHARMACEUTICALS

Quality control of radiopharmaceuticals.

Written and trained procedures in preparation and

safe handling of radiopharmaceuticals

Use of a unique code which guarantee the ability

to trace the origin of all components in the preparation.

Records ofradionuclides, kits etc.

Labeling of vials and syringes.

Measurement of activity.

53. PREPARATION OF RADIOPHARMACEUTICALS Tc99m-MDP 22375 447SC 1997-09-287.40

Use a transparent vial shield

Put the kit in the shield

Add Tc99m and finish the

preparation

Measure the activity

Write the label and put it on

the vial shield

Check the kit and the label on

the vial shield. Same radiopharma-

ceutical?

54. DISPENSING RADIOPHARMACEUTICALS Tc99m-MDP 400 MBq 400928-3336 1997-09-28 07.45 SC

Check kit and vial shield label

Correct radiopharmaceutical?

Draw the required volume

Measure the activity

Write the label and put it on

the syringe shield

55. INJECTING RADIOPHARMACEUTICALS

Patient name?

Patient identification number?

Pregnant?

Breastfeeding?

Check the request form

Check the label of the syringe.

Correct radiopharmaceutical

for the required examination?

Correct activity?

Inject!

56. Worker The worker should always feel confident that he/she has the necessary training in order to perform his/her duty. The worker should feel that he/she gets the necessary support from the licensee in matters concerning working situation and safety. 57. FACTORS AFFECTING QUALITY

Design of facility

Safe receipt and storage of unsealed sources

Safe handling of unsealed sources

Management of radioactive waste

Safety equipment

Personal monitoring

Health surveillance

Workplace monitoring

Emergency procedures

Local rules

Training and experience of staff

58. EDUCATION OF STAFF Correct use of equipment Close15 cmWrong setting of energy window 59. Module 9.5. Instrumentation Part 9. Quality Assurance IAEATrainingMaterialonRadiation Protectionin Nuclear Medicine 60. How to get a new Gamma camera? Step 1 61. PURCHASE GROUP

Nuclear medicine specialist

Nuclear medicine technologist

Medical physicist

Medical engineer

Person from the hospital administration

62. How to open the safe? Careful analysis of the need and state the reasons for the purchase of the gamma camera

Establishment of a nuclear medicine service

Increased volume of patients

The technical performance is not good enough

for new methods

No spare parts available

Unrepairable

63. How many cameras? As an example ,let us assume that in a certain region of a country having a stable population of 150000 there are plans to establish a nuclear medicine facility. The mean number of examinations in the country is 15 per 1000 population and year but the new department should be designed to fulfil a future need of 20 per 1000 population, which means that the total number of examinations will be 3000 per year or 60 per week 64. Basic calculation *) depends on the type of camera 65. Result Number of cameras If we assume that the number of hours per week a gammacamera can be effectively used for patient examinations to be 28 (70% of 40) then the number of cameras should be 66/28=2.4. This figure should be further corrected by taking into account the time needed for regular maintenance of the equipment as well as unplanned stops due to different failures. 66. End of step 1 No! Yes! 67. Let the vendor define Your needs andmake the selection Step 2 Write a tenderdocument and distribute it to the vendors 68. Choice of equipment

Type of procedure to be undertaken

Technical specifications

Manufacturer

Spare parts

Service and maintenance

User and service manuals

Local user

Service and maintenance

Education and experience of staff

Siting of the instrument

Ease, reliability and safety in operation

69. Siting of equipment

Sufficient space

Electrical power

Environmental factors (temperature,

humidity, air pollution)

Structural shielding

Background radiation

70. MAINTENANCE

Regular maintenance will result in:

Increased availability of equipment

Increased quality by better performance

Increased safety

Increased lifetime of equipment

71. Maintenance procedures

should include consideration of the following:

Overall management of the maintenance programme. This is often

provided by the medical physicist in co-operation with the RPO;

Measures to prevent the use of equipment during periods of

maintenance;

Notification of the medical physicist whenever there is a repair,

regardless of its importance.The physicist must assess whether any

tests or measurements are to be made and whether the equipment is

operating satisfactorily before it is used with patients;

Provision of a service contract covering preventative maintenance,

particularly when equipment parts and expertise areprovided by the

manufacturer;

Maintenance of a service recordduring the lifetime of the equipment

or for a duration specified by the Regulatory Authority.

72. EQUIPMENT

Well trained staff with access to manuals

and other documentation.

Quality control program.

Regular maintenance.

NEEDS FOR EFFICIENT USE 73. Purpose of tendering The purpose of tendering for gamma cameras is to assess the best match between the requirements of the clinical department and the equipment available and not necessarily to buy the 'best camera. 74. What do we want? Hardware One, two or three detector heads? Round, square or rectangular detector? Crystal thickness? Collimators? Whole body scanning? PET-option? Transmission source? 75. What do we want? Computer & software Acquisition modes? Application programmes? Network? Storage capacity? Backup? 76. What do we want? More... Education and training Payment Warranty Reliability Service and maintenance List of users Manuals and other documentation Time of delivery Upgradability Quality control equipment Acceptance test 77. The tender document should therefore include:

System overview

Contact persons

Commercial specifications

Technical specifications

Data acquisition and processing

Electrical and mechanical safety (national regulations)

Documentation

Service organization

Installation and acceptance testing

78. What shall the vendor specify?

Commercial specifications:

Payment

Warranty

Liability insurance for installers

Right to refuse or remove equipment

Value of the old camera

Hardware:

Crystal size and shape

PM-tubes

Gantry dimension and weight

Gantry movements, including auto-contour

Electrical power requirements

Imaging table

Collimators and method of change

Shielding of detector

Operating console

Energy windows

Energy range

Safety features

Motion control

Technical performance:

Linearity

Uniformity (different energies, different angles)

Energy resolution

Spatial resolution (intrinsic and system, planar and tomographic)

Count rate performance

Center of rotation

Multiple window spatial positioning

System sensitivity (planar and tomographic)

Point source sensitivity

Computer system:

Acquisition modes

Basic application programmes

Clinical application programmes

Quality control programmes

DICOM-standard

Network and communication

Printers

Storage and backup of patient data

What shall the vendor specify? 82. What shall the vendor specify?

..and more:

User lists and site visits

Reliability (e.g. 95%)

Service response time and follow up

Training now and later

Service manuals

Upgradability

Delivery, setup and installation date

Floor loading, elevators and doors

Electrical requirements

83. End of step 2 Distribute the tender documents to the vendors RELAX! 84. Step 3 The decision: Which camera fulfills our requirements? 85. The decision

Can the camera and the computer software be used

efficiently for all types of intended examinations?

Are the technical specifications satisfactory?

Is the camera easy to handle?

Is the price reasonable?

Is the manufacturers service organization satisfactory?

Is the required training OK?

86. Site visits 87. The decision- End of step 3 Manufacturer 1 + price + technical parameters - service - computer system Manufacturer 2 + price - technical parameters + service - computer system We want that one!! 88. Step 4

Make a clear and detailed specification of the implementation agreement.

Which are the users responsibilities?

Which are the vendors responsibilities?

Which documents are valid?

Date of delivery?

Mode of payment?

Warranty?

Sign the contract Make the installation Perform an acceptance test 89. QUALITY CONTROL EQUIPMENT Acceptance / reference testing. Measurements to assess whether instrumentation comply with its specifications. Manual available. Routine testing. Performed to maintain high quality and standard of the equipment. Analysis of results. Is the observed result significantly different from the reference testing? Is the observed result due to errors in the QC procedure? Records. 90. Acceptance tests X-ray installations 171 Passed 10 Passed after minor corrections 123 Not passed 38 (SSI 1992) 91. QC GAMMA CAMERA AcceptanceDailyWeeklyYearly Uniformity P T T P Uniformity, tomography P P Spectrum display P T T P Energy resolution P P Sensitivity P T P Pixel size P T P Center of rotation P T P Linearity P P Resolution P P Count losses P P Multiple window pos P P Total performance phantom P P P: physicist,T: technician 92. Module 9.6. Education and training Part 9. Quality Assurance IAEATrainingMaterialonRadiation Protectionin Nuclear Medicine 93. How to achieve a high standard of safety in a hospital?

Safety culture

Support from the hospital management

Well educated staff

Local radiation protection organization

Quality assurance programme

Use of authorized services

Continuing education and training

Arrangements for individual

monitoring and health surveillance

Records

Documented local rules and procedures

94. Education and Training are essential for aradiation protection programme

As part of a the implementation of a Radiation Protection Programme (IAEA TECDOC 1040, 2.2.1): Early in the process a decision should be made about additional training required for the hospital staff

The relevant plan should include who, where and when shall be trained.

95. Responsibility of the licensee

BSS 2.30.: Provision shall be made for reducing as far as practicable the contribution of human error to accidents and other events that could give rise to exposures, by ensuring that:

(a) all personnel on whom protection and safety depend be appropriately trained and qualified so that they understand their responsibilities and perform their duties with appropriate judgement and according to defined procedures;

96. Education

All staff in nuclear medicine must have appropriate education to perform their duties

For radiation protection purposes this affects particularly:

Radiation Protection Officer

Physician

Qualified Expert (Medical Physicist)

Nuclear Medicine Technician

97. Education and training

Personnel shall be instructed in radiation protection before assuming duties:

the conditions of the licence;

safe use and operation of equipment;

instructions that should be provided to patients and patient helpers;

institutional radiation protection policies and procedures (including emergency practice drills);

the local QA programme and QC procedures;

the results of review and analysis of incidents and accidents that have occurred in the institution or elsewhere.

98. A note of qualifications of others

There should also be a process in place which ensures that outside contractors on whom radiation protection may depend (e.g. service engineers) are appropriately trained and qualified.

99. EDUCATION AND TRAINING In addition to the staff working within the nuclear medicine department, the following staff should receive instruction from the RPO: nurses in wards with radioactive patients; staff who do not belong to the nuclear medicine practice but need to enter controlled areas; and staff who transport radioactive patients or radioactive materials within the institution. 100. EDUCATION AND TRAINING * Basic and continuing training for those who have responsibilities for the operation of the equipment or for preparations of radiopharmaceuticals. * Advanced training for physicians, physicistsand radiochemists. * Continuing education for those who have operational responsibilities in a nuclearmedicine facility. 101. Continuing Education

It is essential for all staff to have regular updates on radiation protection aspects

Continuing education must be documented

102. Education and Training

If the number of professionals is too small to justify setting up a training course, then international co-operation programs may be used

Distance learning programs may be useful

A course such as the present may play an important role...

103. EDUCATION AND TRAINING Continuing education in annual refresher training courses, and whenever there is a significant change in duties, regulations, terms of the license, or type of radioactive material or instruments used . Topics should be selected from a syllabus which has been approved by the RPC.Today we will talk about Patient safety 104. Radiation protection training programme

Basic radiation physics.

Biological effects of radiation.

International standards in Radiation Protection

Responsibility and duties.

Safe handling of radioactive materials.

Occupational radiation protection.

Medical exposure.

Management of radioactive waste.

Protection of the public.

Emergency preparedness.

Organization of radiation protection

105. Training Record The records should include the following information: (a)Name of the person(s) who delivered theinstruction or training; (b)Name of the person(s) who received the instructionor training; (c)Date and duration of the instruction or training; (d) List of the topics addressed; (e)Copy of the certificates of training 106. Education & Training

The Regulatory Authority should establish training curricula for (for example) :

members of the RPC

relevant physicians

medical physicists

laboratory staff

107. The role of Regulatory Authority

Require key personnel (named in RPP) to be duly accredited/qualified and to have adequate training in radiation protection.

Specify/approve minimum training standards/syllabus content for radiation protection training courses.

Provide training courses, perhaps in conjunction with other contributors, if courses are otherwise unavailable in the country.

108. Continuous Quality Improvement

CQI - many other acronyms are available for this

Part of virtually all QA systems

Improved methods are documented in clinical trial reports.

Quality assurance protocols are continuously under development in many countries

Regular Quality Assurance meeting for all members of a Section

Continuing education - lectures, workshops, journal clubs and must be available for all staff

109. And finally: QA is not a threat, it is an opportunity

It is essential in a QA program that all staff feel free to report errors

A non threatening environment must exist

Reward honesty with encouragement

Education is the key, not punishment

110. What is this? Communication! 111. Questions? 112. DISCUSSION How should the quality of a nuclear medicine practice be measured? 113. DISCUSSION Discuss the responsibilities in QA for the different members of the nuclear medicine staff . 114. DISCUSSION

Which one of the following practices has the highest quality of the practice:

The most modern equipment and unqualified persons running it.

Old equipment and qualified people running it.

115. Where to Get More Information