Quality Management for Radiological Equipment

Quality Management for Quality Management for Radiological EquipmentRadiological Equipment

David Huang, PhD, DABRDavid Huang, PhD, DABRChief, Medical PhysicsChief, Medical Physics

Memorial Sloan-Kettering Cancer Memorial Sloan-Kettering Cancer CenterCenter

IntroductionsIntroductions

Every patient with cancer deserves Every patient with cancer deserves to receive the best possible to receive the best possible management to achieve cure, long-management to achieve cure, long-term tumor control or palliationterm tumor control or palliation

Every patient comes for diagnosis Every patient comes for diagnosis deserves to receive the correct deserves to receive the correct diagnosis with minimum side effect diagnosis with minimum side effect from radiation to get a earlier from radiation to get a earlier detection of diseasedetection of disease


Radiation equipment is a great device for Radiation equipment is a great device for diagnostics and treatment, however, the diagnostics and treatment, however, the nature of radiation may cause radiation-nature of radiation may cause radiation-induced side effects to the patientsinduced side effects to the patients

Balance between “Benefit” and “Risk” is Balance between “Benefit” and “Risk” is an essential for radiation equipment usean essential for radiation equipment use

Cost effectiveness also an important issue Cost effectiveness also an important issue under nowadays medical environmentunder nowadays medical environment


The comprehensive Quality The comprehensive Quality Management program has clinical, Management program has clinical, physical, and administrative physical, and administrative components and its implementation components and its implementation requires the team work of all personnelrequires the team work of all personnel

The physician, physicist, and The physician, physicist, and technologist along with other member technologist along with other member of the team should collaborate on of the team should collaborate on developing a written QA program for developing a written QA program for Quality Management programQuality Management program


The QA program details the quality The QA program details the quality control tests and procedures, their control tests and procedures, their frequency, the action criteria, the frequency, the action criteria, the records required and the personnel records required and the personnel required to perform themrequired to perform them

The QA program should have a QA The QA program should have a QA committee and include a feedback committee and include a feedback mechanism to that committee so that mechanism to that committee so that the cause of any shortcomings can be the cause of any shortcomings can be addressed and correctedaddressed and corrected


JCAHO requires that QA in radiation JCAHO requires that QA in radiation field be a part of the hospital’s QA field be a part of the hospital’s QA program, and more recently, that a program, and more recently, that a program of continuous quality program of continuous quality improvement be implementedimprovement be implemented

JCAHO states that “the physician JCAHO states that “the physician director of the radiation services is director of the radiation services is responsible for ensuring that the QA responsible for ensuring that the QA program is implementedprogram is implemented


A policies and procedures manual is A policies and procedures manual is required by JACHO. It should be required by JACHO. It should be updated as procedure changed, and updated as procedure changed, and should be reviewed once per year and should be reviewed once per year and signed and dated by the appropriate signed and dated by the appropriate section headsection head

External review of the QA programs External review of the QA programs and procedures by qualified experts is and procedures by qualified experts is an important aspect of a quality auditan important aspect of a quality audit

QA Test of Radiation QA Test of Radiation EquipmentEquipment

Test Category:Test Category:

-Safety-Safety

-Mechanical-Mechanical

-Dosimetry-Dosimetry

-Image Quality-Image QualityTest Frequency:Test Frequency:

Daily, Weekly, Monthly, Quarterly, Daily, Weekly, Monthly, Quarterly, Semi-annual, and AnnualSemi-annual, and Annual

Radiation Therapy EquipmentRadiation Therapy Equipment

TG Reports are good TG Reports are good references/standards for QA proceduresreferences/standards for QA procedures

Federal and States start to monitor Federal and States start to monitor Linac QA as well as Co-60 machineLinac QA as well as Co-60 machine

For new machine, you need to submit For new machine, you need to submit Acceptance/commissioning results and Acceptance/commissioning results and radiation survey resultsradiation survey results

Inspector visit site once per year for Inspector visit site once per year for Policy/procedure manual and QA Policy/procedure manual and QA recordsrecords

Radiology Equipment QARadiology Equipment QA

TG reports are also good TG reports are also good reference/standard for QA proceduresreference/standard for QA procedures

Inspector visits site once per year for Inspector visits site once per year for policy and procedure manual and QA policy and procedure manual and QA recordrecord

Special requirement for Mammograph Special requirement for Mammograph unit, QA procedure, personnel unit, QA procedure, personnel qualification, site accreditation…qualification, site accreditation…

MR is monitored by medical societyMR is monitored by medical society

General Items for RadiologyGeneral Items for Radiology

Film Darkroom QA:Film Darkroom QA:

-Darkroom environment-Darkroom environment

-Viewbox QC-Viewbox QCProcessor QA:Processor QA:

-Chemical activities-Chemical activities

-Processor cleaning process-Processor cleaning process

-Processor monitoring-Processor monitoring

QC of Radiographic/FluoroscopicQC of Radiographic/FluoroscopicEquipment Equipment

Visual inspectionsVisual inspectionsEnvironment inspectionsEnvironment inspectionsPerformance testing:Performance testing:

Reproducibility of exposure, Focal spot Reproducibility of exposure, Focal spot size, Filtration check, kVp accuracy, size, Filtration check, kVp accuracy, mA linearity, High- and low-contrast mA linearity, High- and low-contrast resolution, Spatial resolution, SSD, resolution, Spatial resolution, SSD, distortion, image noise…..distortion, image noise…..

NY State Guidelines for CT QANY State Guidelines for CT QA

PurposePurpose

The Department of Health has The Department of Health has implemented this program to reduce implemented this program to reduce radiation exposure, optimize radiation exposure, optimize diagnostic image quality and foster diagnostic image quality and foster facility involvement in the facility involvement in the responsibility for Quality Assurance responsibility for Quality Assurance (QA)(QA)


ALARAALARA

This guideline has been established This guideline has been established on the ALARA principle to ensure that on the ALARA principle to ensure that the benefits of ionizing radiation the benefits of ionizing radiation exceed the risks to the individual and exceed the risks to the individual and the public health and safetythe public health and safety


Limits and StandardsLimits and Standards

The control limits and standards used in The control limits and standards used in this guide have been taken from this guide have been taken from Federal Performance Standard for Federal Performance Standard for Diagnostic X-ray Equipment Diagnostic X-ray Equipment (21CFR1020), Part 16, and AAPM Report (21CFR1020), Part 16, and AAPM Report #74. Equipment problems should be #74. Equipment problems should be documented and shall be corrected documented and shall be corrected with appropriate documentation within with appropriate documentation within thirty (30) days of discoverythirty (30) days of discovery


Responsibility:Responsibility:

Large facilities can absorb the Large facilities can absorb the responsibilities and structure for CT responsibilities and structure for CT QA into their existing committee that QA into their existing committee that is responsible for overseeing is responsible for overseeing diagnostic radiologydiagnostic radiology


Responsibility:Responsibility:

For small facilities, radiation safety and For small facilities, radiation safety and QA is the responsibility of the physician QA is the responsibility of the physician who registers the equipmentwho registers the equipment

The responsibility for CT equipment The responsibility for CT equipment PM/QC testing falls upon several PM/QC testing falls upon several professional groups, Medical Physicists, professional groups, Medical Physicists, Radiologic Technologist, in-house Radiologic Technologist, in-house engineering, and manufacturer service engineering, and manufacturer service representativesrepresentatives


RecordsRecords

- Manual- Manual

- Equipment Records- Equipment Records

- Processor and Sensitometer Logs- Processor and Sensitometer Logs

- QC Records for Test Equipment- QC Records for Test Equipment

- radiation Safety Policies and - radiation Safety Policies and ProceduresProcedures


Equipment MonitoringEquipment Monitoring

Each facility shall have QC tests to Each facility shall have QC tests to monitor equipment performance and monitor equipment performance and maintain records of data collectedmaintain records of data collected

If at the time of inspection, If at the time of inspection, significant equipment malfunctions significant equipment malfunctions are found, the facility may be are found, the facility may be required to perform more frequent required to perform more frequent testing to ensure good diagnostic testing to ensure good diagnostic image qualityimage quality


Equipment MonitoringEquipment Monitoring

This guide describes a basic Radiation This guide describes a basic Radiation Safety/QA Program and represents only Safety/QA Program and represents only a portion of the QC tests your facility a portion of the QC tests your facility may choose to perform as part of your may choose to perform as part of your individual programindividual program

Appropriate QC testing must be Appropriate QC testing must be conducted whenever major conducted whenever major maintenance (X-ray tuble replacement) maintenance (X-ray tuble replacement) or a change in equipment operation or a change in equipment operation (software change) occurs(software change) occurs


Equipment Monitoring: each day of Equipment Monitoring: each day of operationoperation

- Equipment functioning: check any - Equipment functioning: check any malfunction, evaluate the mechanical malfunction, evaluate the mechanical and and electrical safetyelectrical safety

- CT number accuracy of water, Image - CT number accuracy of water, Image noise, noise, Image uniformity, and Artifact Image uniformity, and Artifact evaluation evaluation shall be performed daily shall be performed daily using a common using a common technique setting with technique setting with a head size a head size phantomphantom


Equipment Monitoring: monthlyEquipment Monitoring: monthly

- Image slice thickness or Slice - Image slice thickness or Slice sensitivity sensitivity profileprofile

- Slice positioning accuracy- Slice positioning accuracy

- CT number scale accuracy- CT number scale accuracy

- Hard copy device- Hard copy device


Equipment Monitoring: semi annuallyEquipment Monitoring: semi annually

- Dose profile width- Dose profile width

- Spatial resolution- Spatial resolution

- Low contrast detestability- Low contrast detestability

Equipment Monitoring: annuallyEquipment Monitoring: annually

- Patient dose- Patient dose


Equipment Monitoring: on installation Equipment Monitoring: on installation of new tubeof new tube

All weekly and monthly tests must be All weekly and monthly tests must be completed before patient completed before patient examinations commence. All semi-examinations commence. All semi-annual and annual tests must be annual and annual tests must be completed within thirty days of tube completed within thirty days of tube replacementreplacement


Equipment Monitoring: on installation Equipment Monitoring: on installation of new unitof new unit

Same as new tube, plusSame as new tube, plus

- Half-value layer- Half-value layer

- Radiation protection survey- Radiation protection survey

- Scan protocols- Scan protocols

- Log book- Log book

Mammography Quality Standards Mammography Quality Standards ActAct

Before 1992, quality standards for Mammo. Before 1992, quality standards for Mammo. were the responsibility of individual agencieswere the responsibility of individual agencies

ACR began a voluntary Mammo. ACR began a voluntary Mammo. Accreditation Program (MAP) in 1987Accreditation Program (MAP) in 1987

The Mammo. Quality Standards Act (MQSA) The Mammo. Quality Standards Act (MQSA) passed on Oct. 27, 1992passed on Oct. 27, 1992

This law requires all facilities (except VA This law requires all facilities (except VA hospital) be accredited by an approved hospital) be accredited by an approved accreditation body and certified by the accreditation body and certified by the Secretary of the Health and Human Service Secretary of the Health and Human Service to legally provide Mammo service.to legally provide Mammo service.

MQSAMQSA

Accreditation of Mammo. facilities by private Accreditation of Mammo. facilities by private nonprofit organization (ACR) or State nonprofit organization (ACR) or State agencies that have met the standards agencies that have met the standards established by FDAestablished by FDA

An annual Mammo. facility physics survey, An annual Mammo. facility physics survey, consultation, and evaluation performed by a consultation, and evaluation performed by a qualified medical physicistqualified medical physicist

Annual inspection of Mammo. facility by Annual inspection of Mammo. facility by FDA-certified federal and state agenciesFDA-certified federal and state agencies

Establishment of initial and continuing Establishment of initial and continuing qualification standards for MD, Physicist, qualification standards for MD, Physicist, Technologist, and InspectorTechnologist, and Inspector

MQSAMQSA

Specification of board or organization Specification of board or organization eligible to certify the adequacy of training eligible to certify the adequacy of training and experience of Mammo. personneland experience of Mammo. personnel

Establishment of quality standards for Establishment of quality standards for Mammo. equipment and practicesMammo. equipment and practices

Establishment of a National Mammo. QA Establishment of a National Mammo. QA Advisory Committee (NMQAAC) to advise Advisory Committee (NMQAAC) to advise FDA of appropriate quality standardsFDA of appropriate quality standards

Standards governing record keeping for Standards governing record keeping for exam files and requirements for Mammo. exam files and requirements for Mammo. reporting and exam notification by reporting and exam notification by physicianphysician

MQSAMQSA

Specific regulations for accrediting bodiesSpecific regulations for accrediting bodies General facility provision: specific guidelines of General facility provision: specific guidelines of

Mammo. report, definition of the responsibilities Mammo. report, definition of the responsibilities of facility personnel, review of Mammo. Medical of facility personnel, review of Mammo. Medical outcomes audit data at least every 12 outcomes audit data at least every 12 months…months…

Personnel regulations for interpreting Personnel regulations for interpreting physicians, medical physicists, and physicians, medical physicists, and mammographersmammographers

New equipment requirements to reduce the New equipment requirements to reduce the cost of replacing or retrofitting equipment cost of replacing or retrofitting equipment before its normal replacement datebefore its normal replacement date

Quality Control ResponsibilitiesQuality Control Responsibilities

Radiologist (Interpreting Physician)Radiologist (Interpreting Physician)

- the primary responsibility for Mammo. - the primary responsibility for Mammo. QC is the lead interpreting physicianQC is the lead interpreting physician

Medical PhysicistMedical Physicist

- responsible for the QC evaluation of the - responsible for the QC evaluation of the Mammo. equipmentMammo. equipment

Radiologic Technologist (Mammographer)Radiologic Technologist (Mammographer)

- responsible for QC measurements of the - responsible for QC measurements of the Mammo. equipmentMammo. equipment


Medical Physicist’s dutiesMedical Physicist’s duties

- Visual inspection of Mammo. Assembly- Visual inspection of Mammo. Assembly

- Collimation assessment- Collimation assessment

- Focal spot size- Focal spot size

- kVp reproducibility- kVp reproducibility

- Beam quality assessment- Beam quality assessment

- Timer accuracy- Timer accuracy

- AEC systems- AEC systems


Medical Physicist’s duties (continue)Medical Physicist’s duties (continue)

- Uniformity of screen speed - Uniformity of screen speed

- Breast entrance exposure- Breast entrance exposure

- Average glandular dose- Average glandular dose

- Image quality evaluation- Image quality evaluation

- Artifact evaluation- Artifact evaluation

- Collimation- Collimation


Mammographer’s dutiesMammographer’s duties

- Daily: - Daily:

Darkroom cleanliness Darkroom cleanliness

Processor quality controlProcessor quality control

- Weekly:- Weekly:

Screen cleanlinessScreen cleanliness

Viewboxes and viewing conditionsViewboxes and viewing conditions


Mammographer’s duties (continue)Mammographer’s duties (continue)

- Monthly: - Monthly:

Phantom image Phantom image

Visual inspection: SID, Field light…Visual inspection: SID, Field light…

- Quarterly:- Quarterly:

Repeat analysisRepeat analysis

Archival qualityArchival quality


Mammographer’s duties (continue)Mammographer’s duties (continue)

- Semiannual: - Semiannual:

Darkroom fog Darkroom fog

Film-screen contactFilm-screen contact

CompressionCompression


FDA inspectionFDA inspection

- Equipment performance: - Equipment performance:

Collimation systemCollimation system

Entrance skin exposure and exposure Entrance skin exposure and exposure reproducibilityreproducibility

Beam quality measurementBeam quality measurement

Phantom image quality evaluationPhantom image quality evaluation

Processor evaluation and darkroom Processor evaluation and darkroom fog fog measurementmeasurement

- Records- Records

MammographyMammography QC/QA QC/QA

Quality control and quality assurance Quality control and quality assurance for mammographic equipment and for mammographic equipment and procedures are mandatory for procedures are mandatory for compliance with MQSA.compliance with MQSA.

Proper documentation of these Proper documentation of these procedures is essential for a facility procedures is essential for a facility to remain accredited to perform to remain accredited to perform mammographic proceduresmammographic procedures

QA/QC in Nuclear MedicineQA/QC in Nuclear Medicine

JCAHO states:JCAHO states:

There shall be quality control policies There shall be quality control policies and procedures governing nuclear and procedures governing nuclear medicine activities that assure medicine activities that assure diagnostic and therapeutic reliability diagnostic and therapeutic reliability and safety of patients and personneland safety of patients and personnel

Gamma Camera Quality ControlGamma Camera Quality Control

Energy resolution and photopeaking: Energy resolution and photopeaking: daily and before each new daily and before each new radionuclide usedradionuclide used

Counting rate limits: dailyCounting rate limits: dailyField uniformity: daily, after repairField uniformity: daily, after repairSpatial resolution: weekly, after repairSpatial resolution: weekly, after repairSpatial linearity: weekly, after repairSpatial linearity: weekly, after repairSensitivity: quarterlySensitivity: quarterly

SPECT Camera Quality ControlSPECT Camera Quality Control

Uniformity correction flood : weeklyUniformity correction flood : weeklyCenter of Rotation: weekly for every Center of Rotation: weekly for every

collimator used for tomographycollimator used for tomographyPixel size: monthlyPixel size: monthlyCine to detect patient motion: after Cine to detect patient motion: after

each patient acquisitioneach patient acquisition

PET Quality ControlPET Quality Control

Radial, tangential, and Axial Radial, tangential, and Axial resolutionsresolutions

SensitivitySensitivityLinearityLinearityUniformityUniformityAttenuation accuracyAttenuation accuracyScatter determinationScatter determinationDead time correctionsDead time corrections

Conclusions and SuggestionsConclusions and Suggestions

For high standards Radiotherapy, we need For high standards Radiotherapy, we need a comprehensive QA program for RTa comprehensive QA program for RT

Lots of new treatment techniques and new Lots of new treatment techniques and new treatment equipment are implemented treatment equipment are implemented clinically for Radiotherapy, to make use of clinically for Radiotherapy, to make use of these techniques and equipment these techniques and equipment “efficiently”, we need a comprehensive QA “efficiently”, we need a comprehensive QA program for RTprogram for RT

To improve the treatment outcomes while To improve the treatment outcomes while lower the treatment side effect, we need a lower the treatment side effect, we need a comprehensive QA program for RTcomprehensive QA program for RT


““ Benefits vs Risks” is always an essential Benefits vs Risks” is always an essential for diagnostic radiology. To make benefit for diagnostic radiology. To make benefit “over” risk for any diagnosis in radiology, “over” risk for any diagnosis in radiology, we need a comprehensive QA program for we need a comprehensive QA program for radiology and nuclear medicineradiology and nuclear medicine

Patient dose now becomes a “major” Patient dose now becomes a “major” concern for people undergo diagnosis with concern for people undergo diagnosis with radiation, especially for routine checkout. radiation, especially for routine checkout. For this concern, we need a For this concern, we need a comprehensive QA program for radiology comprehensive QA program for radiology and nuclear medicineand nuclear medicine


The new study from NIH shows that “there The new study from NIH shows that “there is always a risk from radiation, doesn’t is always a risk from radiation, doesn’t matter how small amount of radiation matter how small amount of radiation received”, therefore, radiation safety to received”, therefore, radiation safety to the patients and staffs becomes more the patients and staffs becomes more important than ever. To assure the important than ever. To assure the radiation safety issue in the medical radiation safety issue in the medical radiation fields, we need a comprehensive radiation fields, we need a comprehensive QA program for Radiotherapy, Diagnostic QA program for Radiotherapy, Diagnostic Radiology, and Nuclear Medicine Radiology, and Nuclear Medicine


In US, Government and accreditation agencies In US, Government and accreditation agencies now mandate procedures to ensure that now mandate procedures to ensure that equipment is functioning within accepted equipment is functioning within accepted standards and that it is operated properly.standards and that it is operated properly.

Such procedures must be also appropriately Such procedures must be also appropriately documented.documented.

Because of increasing QA tasks for Because of increasing QA tasks for technologists, they now need additional technologists, they now need additional knowledge. The ARRT has recognized this knowledge. The ARRT has recognized this need by offering an advanced level need by offering an advanced level examination in Quality Management in 1997.examination in Quality Management in 1997.


My suggestions are, and I am willing to help if My suggestions are, and I am willing to help if there is a necessity:there is a necessity:

- A team to study the feasibility of “QA program - A team to study the feasibility of “QA program implementation” for Radiology and Nuclear implementation” for Radiology and Nuclear MedicineMedicine

- A team to address the “outline of QA program”- A team to address the “outline of QA program”

- A team to develop the QA technique as user’s - A team to develop the QA technique as user’s reference reference

- A team from overseas to exchange the - A team from overseas to exchange the experience and to provide updated informationexperience and to provide updated information

Questions?

Documents

Quality Management for Radiological Equipment