QUALITY CONTROLQUALITY CONTROL

For the TechnologistFor the Technologist

TECHNOLOGIST TECHNOLOGIST RESPONSIBILITIESRESPONSIBILITIES

DAILYDAILY Darkroom Darkroom

CleanlinessCleanliness SensitometrySensitometry

WEEKLYWEEKLY Screen CleanlinessScreen Cleanliness Viewbox cleanlinessViewbox cleanliness Phantom ImagingPhantom Imaging

MONTHLYMONTHLY Visual ChecklistVisual Checklist

QUARTERLYQUARTERLY Repeat/Reject Repeat/Reject

AnalysisAnalysis Fixer RetentionFixer Retention

SEMIANNUALLYSEMIANNUALLY CompressionCompression Film/Screen ContactFilm/Screen Contact Darkroom FogDarkroom Fog

DARKROOM CLEANLINESSDARKROOM CLEANLINESS

NEVER:NEVER:Carpet a darkroomCarpet a darkroomStore boxes or cartons and never open Store boxes or cartons and never open

ALWAYS:ALWAYS:Have shelving with doorsHave shelving with doorsReplace filters and service air Replace filters and service air

conditioning conditioning Wipe countertops with damp clothWipe countertops with damp clothWipe film trays with anti-static solutionWipe film trays with anti-static solutionUse a black lightUse a black light

SENSITOMETRYSENSITOMETRY

Must use same box of filmMust use same box of filmMust be performed before clinical filmsMust be performed before clinical filmsCheck Developer temperatureCheck Developer temperatureFlash sensitometric strip on emulsion sideFlash sensitometric strip on emulsion sideSpeed and Contrast Index within +/-.15Speed and Contrast Index within +/-.15B+F within +/-.03B+F within +/-.03Developer within +/-.5 degreesDeveloper within +/-.5 degrees

SENSITOMETRYSENSITOMETRY

When data falls outside of the limitsWhen data falls outside of the limits

TrendsTrends

DocumentationDocumentation

SCREEN CLEANLINESSSCREEN CLEANLINESS

Clean when 3-4 specks shownClean when 3-4 specks shownUse Antistatic solutionUse Antistatic solution4x4 rayon or lintless 100% cotton pads4x4 rayon or lintless 100% cotton padsWipe in circular motion from center outWipe in circular motion from center outLet dryLet dryUse one of many tools available to get Use one of many tools available to get

rid of dustrid of dustCheck with black lightCheck with black light

VIEWBOXESVIEWBOXES

Clean weekly to remove dust, Clean weekly to remove dust, smudges, etcsmudges, etc

Change bulbs every 12-18monthsChange bulbs every 12-18months

Test luminance with light meter (not Test luminance with light meter (not required by MQSA)required by MQSA)

PHANTOM IMAGINGPHANTOM IMAGING

Monitors whole systemMonitors whole systemSimulates a 4.5 cm compressed breastSimulates a 4.5 cm compressed breastConsists of 6 nylon fibers, 5 oxide Consists of 6 nylon fibers, 5 oxide

specks, 5 tumor massesspecks, 5 tumor massesShould be performed:Should be performed:

After any serviceAfter any serviceAfter changes in chemistry or filmAfter changes in chemistry or filmWhenever changes in image quality Whenever changes in image quality

suspectedsuspected

PHANTOM PROCEDUREPHANTOM PROCEDURE

AEC placed same as a 4.5 cm breastAEC placed same as a 4.5 cm breast4mm acrylic disc placed away from 4mm acrylic disc placed away from

objectsobjectsBackground density: center, 1.2 OD Background density: center, 1.2 OD

+/-.2+/-.2Density difference: .4 +/-.05 for films Density difference: .4 +/-.05 for films

at 28kVpat 28kVpChart mAs to evaluate reproducibility Chart mAs to evaluate reproducibility

(should not vary more than +/-.15)(should not vary more than +/-.15)

PHANTOM ANALYSISPHANTOM ANALYSIS

Must see 4 fibers, 3 specks, 3 masses Must see 4 fibers, 3 specks, 3 masses (10)(10)

Can vary +/-1 but no lower than 10 Can vary +/-1 but no lower than 10 objects.objects.

Viewed:Viewed:By same personBy same personSame time of daySame time of dayOn same viewboxOn same viewboxUnder same viewing conditionsUnder same viewing conditionsUsing same type of magnifying lensUsing same type of magnifying lens

VISUAL CHECKLISTVISUAL CHECKLIST

Takes inventory of room to ensure Takes inventory of room to ensure safety, comfort and conveniencesafety, comfort and convenience

FIXER RETENTIONFIXER RETENTION

Performed right after daily strip on Performed right after daily strip on emulsion side in clear areaemulsion side in clear area

Place drop of fixer and let sit 2 Place drop of fixer and let sit 2 minutes (do not expose to bright light)minutes (do not expose to bright light)

Blot dry and place on white cardboardBlot dry and place on white cardboardCompare to chart. No more than Compare to chart. No more than

5ug/cm squared (3 on the chart) 5ug/cm squared (3 on the chart)

REASONS FOR ELEVATED REASONS FOR ELEVATED FIXERFIXER

Inadequate wash water flow rateInadequate wash water flow ratePartially depleted fixer (enough Partially depleted fixer (enough

activity for clearing but not enough for activity for clearing but not enough for hardening)hardening)

Insufficiently hardened emulsion Insufficiently hardened emulsion retains too much fixer for wash to retains too much fixer for wash to remove.remove.

RESULT: Degrades stability of imageRESULT: Degrades stability of image

FIXER CORRECTIONFIXER CORRECTION

Increase fixer replenishmentIncrease fixer replenishment

Increase water flowIncrease water flow

REPEAT/REJECT ANALYSISREPEAT/REJECT ANALYSIS

To evaluate reasons films are To evaluate reasons films are repeatedrepeated

Points out insufficiencies, wastePoints out insufficiencies, waste

Can improve efficiencyCan improve efficiency

REPEAT ANALYSIS REPEAT ANALYSIS PROCEDUREPROCEDURE

Quarterly and at least 250 patients Quarterly and at least 250 patients examinedexamined

Films are categorizedFilms are categorized

ACR states number of repeats should ACR states number of repeats should be no greater than 5%.be no greater than 5%.

WAKE UP! ITS OVER!WAKE UP! ITS OVER!

COMPRESSIONCOMPRESSION

Image quality and safety testImage quality and safety test

Test in both power drive and manualTest in both power drive and manual

MQSA states 25 – 47 lb rangeMQSA states 25 – 47 lb range

How does compression improve How does compression improve quality?quality?

Decrease scatterDecrease scatterDecrease doseDecrease doseDecrease patient motionDecrease patient motion Increase contrastIncrease contrast Increase uniformity of breast tissueIncrease uniformity of breast tissue Increase image sharpness by Increase image sharpness by

decreasing thickness thus decrease decreasing thickness thus decrease focal spot degradationfocal spot degradation

COMPRESSION PROCEDURECOMPRESSION PROCEDURE

Place towelPlace towelPlace scalePlace scalePlace friend’s (soon to be enemy’s) Place friend’s (soon to be enemy’s)

breast on top of scalebreast on top of scaleCompress in power mode until it Compress in power mode until it

stops (never mind the screaming of stops (never mind the screaming of your new enemy)your new enemy)

Compress in manual until it stops Compress in manual until it stops (same as above)(same as above)

COMPRESSION PROCEDURECOMPRESSION PROCEDURE

Place towelPlace towelPlace scalePlace scalePlace several towels on top of scalePlace several towels on top of scaleCompress in power until it stopsCompress in power until it stopsCompress in manual until it stopsCompress in manual until it stops

FILM/SCREEN CONTACTFILM/SCREEN CONTACT

Performed on all new cassettes and/or Performed on all new cassettes and/or semi-annualsemi-annual

More critical than general radiographyMore critical than general radiography

Highlights areas of decreased sharpnessHighlights areas of decreased sharpness

Fine 30-40 copper wire mesh screen Fine 30-40 copper wire mesh screen usedused

FILM/SCREEN CONTACT FILM/SCREEN CONTACT PROCEDUREPROCEDURE

Clean cassettesClean cassettesLet sit for 15 minutesLet sit for 15 minutesEmploy 25-28kVp, no grid, manual Employ 25-28kVp, no grid, manual

mas with .5 secondsmas with .5 secondsPaddle all the way up with acrylicPaddle all the way up with acrylicWire mesh on top of screenWire mesh on top of screen

FILM/SCREEN ANALYSISFILM/SCREEN ANALYSIS

.7-.8OD near chest wall.7-.8OD near chest wallStand 3-6ft backStand 3-6ft back If densities over 1 cm appear, clean If densities over 1 cm appear, clean

and retest.and retest.Remove if large density still appears.Remove if large density still appears.Several small densities acceptable.Several small densities acceptable.

DARKROOM FOGDARKROOM FOG

Inspect with all lights offInspect with all lights offBe aware of luminescent or Be aware of luminescent or

phosphorescent itemsphosphorescent itemsUse radiation exposed filmUse radiation exposed filmMQSA states fog should be no >.05 MQSA states fog should be no >.05

OD when exposed for 2 min.OD when exposed for 2 min.Problems usually lie in safelight Problems usually lie in safelight

position or filtersposition or filters

DARKROOM PROCEDUREDARKROOM PROCEDURE

Load cassette in total darknessLoad cassette in total darkness Expose phantom to 1.0 ODExpose phantom to 1.0 OD Inspect safelightsInspect safelights Turn off lights, inspectTurn off lights, inspect Remove film, insert into template Remove film, insert into template

emulsion upemulsion up Expose sections to safelightsExpose sections to safelights Run film then measure densities on each Run film then measure densities on each

side of linesside of lines

SafelightsSafelights

Filters should correspond with green light Filters should correspond with green light sensitive filmsensitive film

Lamps ~4 ft from work areaLamps ~4 ft from work area Wratten 1 or 2, Kodak GBX-2 good Wratten 1 or 2, Kodak GBX-2 good

examples of filtersexamples of filters No >15watt bulb in overhead fixtureNo >15watt bulb in overhead fixture No >7.5 watt in closer fixturesNo >7.5 watt in closer fixtures Printing on filter should face outPrinting on filter should face out Change filters every 1-2 yearsChange filters every 1-2 years

AIR QUALITYAIR QUALITY

Temperature: 70 degrees FTemperature: 70 degrees F

Humidity: 30-50%Humidity: 30-50%

Ventilation: for image quality and Ventilation: for image quality and technologists’ healthtechnologists’ health

PROCESSOR MAINTENANCEPROCESSOR MAINTENANCE

Developer temperatureDeveloper temperature Increase can cause fogIncrease can cause fog Decrease can result in:Decrease can result in:

Decrease in film speed and contrastDecrease in film speed and contrastHigher dose to ptHigher dose to pt

Fixer temperatureFixer temperature Decrease can affect archival of filmDecrease can affect archival of film

Wash-water temperatureWash-water temperature Can cause biological growth in tankCan cause biological growth in tank Can affect developer and fixer temps, improper Can affect developer and fixer temps, improper

washwash

PROCESSING CONTINUED…PROCESSING CONTINUED…

Chemical replenishmentChemical replenishmentRates inconsistent when processor left Rates inconsistent when processor left

on and not usedon and not usedCheck solution levelsCheck solution levels

PROCESSING: STANDARDPROCESSING: STANDARD

Typically used for general Typically used for general radiographyradiography

Faster cycle time (usually 90sec)Faster cycle time (usually 90sec)

Developer immersion ~23 sec Developer immersion ~23 sec

Can accommodate single and doubleCan accommodate single and double

PROCESSING: EXTENDEDPROCESSING: EXTENDED

Difference from standard is Difference from standard is developer immersion time (~45sec)developer immersion time (~45sec)

““Push” more contrast and speed Push” more contrast and speed from the filmfrom the film

Less exposure needed with increase Less exposure needed with increase in film speedin film speed

Increase in tube lifeIncrease in tube lifeDownfall is an increase in noiseDownfall is an increase in noise

TYPES OF PROCESSORSTYPES OF PROCESSORS

Small desktopSmall desktopDISADVANTAGESDISADVANTAGES

Straight-through require careful adjustments Straight-through require careful adjustments to replenishmentto replenishment

Developer not sprayed evenlyDeveloper not sprayed evenly

ADVANTAGESADVANTAGESCost, small, fewer rollers, two developer Cost, small, fewer rollers, two developer

stations,stations,Less chance of oxidationLess chance of oxidation

TYPES OF PROCESSORSTYPES OF PROCESSORS

Large stand-aloneLarge stand-aloneDISADVANTAGESDISADVANTAGES

Artifacts from rollersArtifacts from rollersSpaceSpace

ADVANTAGESADVANTAGESAgitates chemicals which increases supply Agitates chemicals which increases supply

of fresh chemicalsof fresh chemicals

ARTIFACTSARTIFACTS

ProcessingProcessingEnvironmentalEnvironmentalHandlingHandlingPositioningPositioningEquipmentEquipment

SENSITOMETRIC STRIP SENSITOMETRIC STRIP Establishing the baselineEstablishing the baseline

Expose and process 5 stripsExpose and process 5 stripsAverage readings for temporary baseAverage readings for temporary baseProcess one strip per day for 5 daysProcess one strip per day for 5 days

If strip is out of tolerance, correct and If strip is out of tolerance, correct and repeatrepeat

Watch for trend due to seasoning effectWatch for trend due to seasoning effectAverage these 5 strips for new baseAverage these 5 strips for new baseBaseline maintained unless film, Baseline maintained unless film,

chemistry or processing alteredchemistry or processing altered

CROSSOVERCROSSOVER

Performed when changing box of filmPerformed when changing box of film

10-12 sheets remaining in old box10-12 sheets remaining in old box

Do not perform after processor Do not perform after processor cleaningcleaning

CROSSOVER PROCEDURECROSSOVER PROCEDURE

Perform in total darknessPerform in total darkness Expose 5 old and 5 newExpose 5 old and 5 new Alternate old and new Alternate old and new Distinguish old from newDistinguish old from new Measure steps used in daily QCMeasure steps used in daily QC Average 5 readings from each boxAverage 5 readings from each box Subtract old from newSubtract old from new Add/Subtract results to/from original aim Add/Subtract results to/from original aim

valuesvalues

CROSSOVER RESULTSCROSSOVER RESULTS

Results must be within +/- .10Results must be within +/- .10

If greater than .15 difference, contact If greater than .15 difference, contact film manufacturer representativefilm manufacturer representative

(D(Dudes udes PPrefer) (refer) (SSex, ex, VViolence and iolence and PPartying) artying) over (over (VVisiting) (isiting) (RRelatives elatives FFor) (or) (CChristmas hristmas DDay ay FFeasts.)easts.)

QUALITY ASSURANCEQUALITY ASSURANCE

Defined as all those planned and Defined as all those planned and systematic actions necessary to systematic actions necessary to provide high image quality.provide high image quality.

QUALITY MANAGEMENTQUALITY MANAGEMENT

Part of the management function which Part of the management function which determines and controls quality policy.determines and controls quality policy.

Making appointmentsMaking appointments Call back protocolCall back protocol Obtaining previous mammogramsObtaining previous mammograms Patient educationPatient education Patient intakePatient intake Problem solvingProblem solving

QUALITY CONTROLQUALITY CONTROL

The set of operations necessary to The set of operations necessary to maintain or improve quality.maintain or improve quality.

QUALITY SYSTEM QUALITY SYSTEM

Assignment of responsibilityAssignment of responsibilityEstablishment of standardsEstablishment of standardsStaff trainingStaff trainingProper documentation of proceduresProper documentation of proceduresQC of equipment at installation and QC of equipment at installation and

throughout its lifethroughout its life

MQSA of 1992MQSA of 1992

As of Oct 1, 1994, all mammography As of Oct 1, 1994, all mammography facilities in the U.S. (except those of Dept facilities in the U.S. (except those of Dept of Veterans Affairs) were required to be of Veterans Affairs) were required to be certified by the FDA as meeting certified by the FDA as meeting mammography quality in order to lawfully mammography quality in order to lawfully continue to perform Mammography.continue to perform Mammography.

Goal: to assure that Mammography is safe Goal: to assure that Mammography is safe and reliable to allow detection of breast CA and reliable to allow detection of breast CA in its earliest most treatable stages.in its earliest most treatable stages.

MQSA REGULATIONSMQSA REGULATIONS To operate lawfully, a mammography To operate lawfully, a mammography

facility must be certified by the FDA.facility must be certified by the FDA. In order to be certified, a facility must first In order to be certified, a facility must first

be accredited by a federally-approved be accredited by a federally-approved private nonprofit or state accreditation private nonprofit or state accreditation body.body.

To be accredited, the facility must undergo To be accredited, the facility must undergo periodic review of clinical images; surveyed periodic review of clinical images; surveyed annually by a medical physicist; meet annually by a medical physicist; meet standards for personnel qualifications, standards for personnel qualifications, equipment QA programs, and record equipment QA programs, and record keeping and reporting.keeping and reporting.

Facility must undergo annual inspections.Facility must undergo annual inspections.

ACCREDITATIONACCREDITATION

A survey form completed by facilityA survey form completed by facilityPhantom images submitted to evaluate Phantom images submitted to evaluate

image qualityimage qualityDosimeter visible on phantom and dose Dosimeter visible on phantom and dose

measuredmeasuredClinical images submitted for evaluationClinical images submitted for evaluationOnce initial paperwork approved, facility Once initial paperwork approved, facility

submits 30 days of processor QC stripssubmits 30 days of processor QC strips

CERTIFICATIONCERTIFICATION

Awarded by the FDA as providing Awarded by the FDA as providing quality mammography services. quality mammography services.

This is awarded upon accreditation This is awarded upon accreditation by a federally-approved accreditation by a federally-approved accreditation body: ACR; States of Arkansas, body: ACR; States of Arkansas, California, and IowaCalifornia, and Iowa

RESPONSIBLE INDIVIDUALSRESPONSIBLE INDIVIDUALS

TECHNOLOGISTTECHNOLOGISTRADIOLOGISTRADIOLOGISTPHYSICISTPHYSICIST

Interpreting Physicians Interpreting Physicians Initial QualificationsInitial Qualifications

• State licenseState license• Diagnostic radiology certification Diagnostic radiology certification OROR 3 3

months of formal trainingmonths of formal training• 60 hours of category I CME in 60 hours of category I CME in

mammographymammography• 240+ mammograms interpreted under 240+ mammograms interpreted under

direct supervisiondirect supervision In the 6 months immediately prior to In the 6 months immediately prior to

independent interpretation independent interpretation OROR If board certified at first allowable time, within If board certified at first allowable time, within

the last 2 years of residencythe last 2 years of residency

Interpreting PhysiciansInterpreting PhysiciansContinuing RequirementsContinuing Requirements

• Continuing experienceContinuing experience Interpret at least 960 examinations / 24 Interpret at least 960 examinations / 24

monthsmonths

• Continuing educationContinuing education At least 15 category I CME credits / 36 monthsAt least 15 category I CME credits / 36 months At least 6 of the 15 CME units must be in each At least 6 of the 15 CME units must be in each

mammographic modality usedmammographic modality used

• 8 hours of training in each mammographic 8 hours of training in each mammographic modality before independent usemodality before independent use

Radiologic TechnologistsRadiologic TechnologistsInitial QualificationsInitial Qualifications

• State license State license OROR certified by FDA- certified by FDA-approved bodyapproved body

• 40 hours of documented 40 hours of documented mammography trainingmammography training

• Performing at least 25 examinations Performing at least 25 examinations under direct supervisionunder direct supervision

• 8 hours of training in each 8 hours of training in each mammographic modality to be used mammographic modality to be used

Radiologic TechnologistsRadiologic TechnologistsContinuing RequirementsContinuing Requirements

• Continuing experienceContinuing experience At least 200 examinations / 24 monthsAt least 200 examinations / 24 months

• Continuing educationContinuing education At least 15 CEUs / 36 monthsAt least 15 CEUs / 36 months At least 6 of the 15 CEUs must be in At least 6 of the 15 CEUs must be in

each mammographic modality usedeach mammographic modality used

• 8 hours of training in each 8 hours of training in each mammographic modality used before mammographic modality used before independent useindependent use

Radiologic TechnologistsRadiologic TechnologistsReestablishing QualificationsReestablishing Qualifications

• Continuing experienceContinuing experience Complete 25 examinations under direct Complete 25 examinations under direct

supervisionsupervision

• Continuing educationContinuing education Bring total continuing education credits Bring total continuing education credits

up to 15 CEUs / 36 monthsup to 15 CEUs / 36 months

Medical PhysicistsMedical PhysicistsInitial RequirementsInitial Requirements

• Licensed or approved by a State Licensed or approved by a State OR OR Certified by FDA-approved bodyCertified by FDA-approved body

• Master’s or higher degree in a physical Master’s or higher degree in a physical sciencescience

• 20 semester hours of physics 20 semester hours of physics • 20 hours of documented mammography 20 hours of documented mammography

survey training survey training • One facility and 10 units surveyedOne facility and 10 units surveyed• 8 hours of training in each modality 8 hours of training in each modality

surveyed before surveying surveyed before surveying independentlyindependently

Medical PhysicistsMedical PhysicistsAlternative Initial Requirements*Alternative Initial Requirements*• Licensed or approved by a State Licensed or approved by a State OROR

Certified by FDA-approved bodyCertified by FDA-approved body

• Maintained active statusMaintained active status

For physicists who were qualified under the interim regulations

Medical PhysicistsMedical PhysicistsAlternative Initial Requirements* Alternative Initial Requirements*

(cont.)(cont.)• Prior April 28, 1999, have:Prior April 28, 1999, have:

Bachelor’s degree in physical science Bachelor’s degree in physical science with at least 10 semester hours of with at least 10 semester hours of physicsphysics

40 hours of documented mammography 40 hours of documented mammography survey training survey training afterafter earning the earning the bachelor’s degreebachelor’s degree

One facility and 20 units surveyed One facility and 20 units surveyed afterafter earning the bachelor’s degreeearning the bachelor’s degree

Medical PhysicistsMedical PhysicistsContinuing RequirementsContinuing Requirements

• Continuing experienceContinuing experience Survey at least 2 facilities and 6 units / Survey at least 2 facilities and 6 units /

24 months24 months

• Continuing educationContinuing education At least 15 CEUs / 36 monthsAt least 15 CEUs / 36 months

• 8 hours of training in any modality 8 hours of training in any modality before surveying independentlybefore surveying independently

MANUALMANUAL

QC MANUALQC MANUALQA MANUALQA MANUAL

QA MANUALQA MANUAL

Details of acceptanceDetails of acceptancePersonnel qualifications and Personnel qualifications and

documentations.documentations.Department policyDepartment policySafety standards Safety standards BiohazardsBiohazards

QC MANUALQC MANUAL

The QC manual is pertinent to ease The QC manual is pertinent to ease the inspection process. It lists:the inspection process. It lists:

Test procedures Test procedures Test frequenciesTest frequenciesTest standards Test standards Unacceptable results as listed as well Unacceptable results as listed as well

as the corrections made for them.as the corrections made for them.