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QUALITY CONTROL For the Technologist TECHNOLOGIST RESPONSIBILITIES DAILY DAILY Darkroom Cleanliness Darkroom Cleanliness Sensitometry Sensitometry WEEKLY.

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Presentation on theme: "QUALITY CONTROL For the Technologist TECHNOLOGIST RESPONSIBILITIES DAILY DAILY Darkroom Cleanliness Darkroom Cleanliness Sensitometry Sensitometry WEEKLY."— Presentation transcript:

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2 QUALITY CONTROL For the Technologist

3 TECHNOLOGIST RESPONSIBILITIES DAILY DAILY Darkroom Cleanliness Darkroom Cleanliness Sensitometry Sensitometry WEEKLY WEEKLY Screen Cleanliness Screen Cleanliness Viewbox cleanliness Viewbox cleanliness Phantom Imaging Phantom Imaging MONTHLY MONTHLY Visual Checklist Visual Checklist QUARTERLY QUARTERLY Repeat/Reject Analysis Fixer Retention SEMIANNUALLY SEMIANNUALLY Compression Film/Screen Contact Darkroom Fog

4 DARKROOM CLEANLINESS NEVER: NEVER: Carpet a darkroom Carpet a darkroom Store boxes or cartons and never open Store boxes or cartons and never open ALWAYS: ALWAYS: Have shelving with doors Have shelving with doors Replace filters and service air conditioning Replace filters and service air conditioning Wipe countertops with damp cloth Wipe countertops with damp cloth Wipe film trays with anti-static solution Wipe film trays with anti-static solution Use a black light Use a black light

5 SENSITOMETRY Must use same box of film Must use same box of film Must be performed before clinical films Must be performed before clinical films Check Developer temperature Check Developer temperature Flash sensitometric strip on emulsion side Flash sensitometric strip on emulsion side Speed and Contrast Index within +/-.15 Speed and Contrast Index within +/-.15 B+F within +/-.03 B+F within +/-.03 Developer within +/-.5 degrees Developer within +/-.5 degrees

6 SENSITOMETRY When data falls outside of the limits When data falls outside of the limits Trends Trends Documentation Documentation

7 SCREEN CLEANLINESS Clean when 3-4 specks shown Clean when 3-4 specks shown Use Antistatic solution Use Antistatic solution 4x4 rayon or lintless 100% cotton pads 4x4 rayon or lintless 100% cotton pads Wipe in circular motion from center out Wipe in circular motion from center out Let dry Let dry Use one of many tools available to get rid of dust Use one of many tools available to get rid of dust Check with black light Check with black light

8 VIEWBOXES Clean weekly to remove dust, smudges, etc Clean weekly to remove dust, smudges, etc Change bulbs every 12-18months Change bulbs every 12-18months Test luminance with light meter (not required by MQSA) Test luminance with light meter (not required by MQSA)

9 PHANTOM IMAGING Monitors whole system Monitors whole system Simulates a 4.5 cm compressed breast Simulates a 4.5 cm compressed breast Consists of 6 nylon fibers, 5 oxide specks, 5 tumor masses Consists of 6 nylon fibers, 5 oxide specks, 5 tumor masses Should be performed: Should be performed: After any service After any service After changes in chemistry or film After changes in chemistry or film Whenever changes in image quality suspected Whenever changes in image quality suspected

10 PHANTOM PROCEDURE AEC placed same as a 4.5 cm breast AEC placed same as a 4.5 cm breast 4mm acrylic disc placed away from objects 4mm acrylic disc placed away from objects Background density: center, 1.2 OD +/-.2 Background density: center, 1.2 OD +/-.2 Density difference:.4 +/-.05 for films at 28kVp Density difference:.4 +/-.05 for films at 28kVp Chart mAs to evaluate reproducibility (should not vary more than +/-.15) Chart mAs to evaluate reproducibility (should not vary more than +/-.15)

11 PHANTOM ANALYSIS Must see 4 fibers, 3 specks, 3 masses (10) Must see 4 fibers, 3 specks, 3 masses (10) Can vary +/-1 but no lower than 10 objects. Can vary +/-1 but no lower than 10 objects. Viewed: Viewed: By same person By same person Same time of day Same time of day On same viewbox On same viewbox Under same viewing conditions Under same viewing conditions Using same type of magnifying lens Using same type of magnifying lens

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14 VISUAL CHECKLIST Takes inventory of room to ensure safety, comfort and convenience Takes inventory of room to ensure safety, comfort and convenience

15 FIXER RETENTION Performed right after daily strip on emulsion side in clear area Performed right after daily strip on emulsion side in clear area Place drop of fixer and let sit 2 minutes (do not expose to bright light) Place drop of fixer and let sit 2 minutes (do not expose to bright light) Blot dry and place on white cardboard Blot dry and place on white cardboard Compare to chart. No more than 5ug/cm squared (3 on the chart) Compare to chart. No more than 5ug/cm squared (3 on the chart)

16 REASONS FOR ELEVATED FIXER Inadequate wash water flow rate Inadequate wash water flow rate Partially depleted fixer (enough activity for clearing but not enough for hardening) Partially depleted fixer (enough activity for clearing but not enough for hardening) Insufficiently hardened emulsion retains too much fixer for wash to remove. Insufficiently hardened emulsion retains too much fixer for wash to remove. RESULT: Degrades stability of image RESULT: Degrades stability of image

17 FIXER CORRECTION Increase fixer replenishment Increase fixer replenishment Increase water flow Increase water flow

18 REPEAT/REJECT ANALYSIS To To evaluate reasons films are repeated Points Points out insufficiencies, waste Can Can improve efficiency

19 REPEAT ANALYSIS PROCEDURE Quarterly and at least 250 patients examined Quarterly and at least 250 patients examined Films are categorized Films are categorized ACR states number of repeats should be no greater than 5%. ACR states number of repeats should be no greater than 5%.

20 WAKE UP! ITS OVER!

21 COMPRESSION Image quality and safety test Image quality and safety test Test in both power drive and manual Test in both power drive and manual MQSA states 25 – 47 lb range MQSA states 25 – 47 lb range

22 How does compression improve quality? Decrease scatter Decrease scatter Decrease dose Decrease dose Decrease patient motion Decrease patient motion Increase contrast Increase contrast Increase uniformity of breast tissue Increase uniformity of breast tissue Increase image sharpness by decreasing thickness thus decrease focal spot degradation Increase image sharpness by decreasing thickness thus decrease focal spot degradation

23 COMPRESSION PROCEDURE Place towel Place scale Place friend’s (soon to be enemy’s) breast on top of scale Compress in power mode until it stops (never mind the screaming of your new enemy) Compress in manual until it stops (same as above)

24 COMPRESSION PROCEDURE Place towel Place towel Place scale Place scale Place several towels on top of scale Place several towels on top of scale Compress in power until it stops Compress in power until it stops Compress in manual until it stops Compress in manual until it stops

25 FILM/SCREEN CONTACT Performed on all new cassettes and/or semi-annual Performed on all new cassettes and/or semi-annual More critical than general radiography More critical than general radiography Highlights areas of decreased sharpness Highlights areas of decreased sharpness Fine copper wire mesh screen used Fine copper wire mesh screen used

26 FILM/SCREEN CONTACT PROCEDURE Clean cassettes Clean cassettes Let sit for 15 minutes Let sit for 15 minutes Employ 25-28kVp, no grid, manual mas with.5 seconds Employ 25-28kVp, no grid, manual mas with.5 seconds Paddle all the way up with acrylic Paddle all the way up with acrylic Wire mesh on top of screen Wire mesh on top of screen

27 FILM/SCREEN ANALYSIS.7-.8OD near chest wall Stand 3-6ft back If densities over 1 cm appear, clean and retest. Remove if large density still appears. Several small densities acceptable.

28 DARKROOM FOG Inspect with all lights off Inspect with all lights off Be aware of luminescent or phosphorescent items Be aware of luminescent or phosphorescent items Use radiation exposed film Use radiation exposed film MQSA states fog should be no >.05 OD when exposed for 2 min. MQSA states fog should be no >.05 OD when exposed for 2 min. Problems usually lie in safelight position or filters Problems usually lie in safelight position or filters

29 DARKROOM PROCEDURE Load cassette in total darkness Expose phantom to 1.0 OD Inspect safelights Turn off lights, inspect Remove film, insert into template emulsion up Expose sections to safelights Run film then measure densities on each side of lines

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31 Safelights Filters should correspond with green light sensitive film Filters should correspond with green light sensitive film Lamps ~4 ft from work area Lamps ~4 ft from work area Wratten 1 or 2, Kodak GBX-2 good examples of filters Wratten 1 or 2, Kodak GBX-2 good examples of filters No >15watt bulb in overhead fixture No >15watt bulb in overhead fixture No >7.5 watt in closer fixtures No >7.5 watt in closer fixtures Printing on filter should face out Printing on filter should face out Change filters every 1-2 years Change filters every 1-2 years

32 AIR QUALITY Temperature: 70 degrees F Temperature: 70 degrees F Humidity: 30-50% Humidity: 30-50% Ventilation: for image quality and technologists’ health Ventilation: for image quality and technologists’ health

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34 PROCESSOR MAINTENANCE Developer temperature Developer temperature Increase can cause fog Increase can cause fog Decrease can result in: Decrease can result in: Decrease in film speed and contrast Decrease in film speed and contrast Higher dose to pt Higher dose to pt Fixer temperature Fixer temperature Decrease can affect archival of film Decrease can affect archival of film Wash-water temperature Wash-water temperature Can cause biological growth in tank Can cause biological growth in tank Can affect developer and fixer temps, improper wash Can affect developer and fixer temps, improper wash

35 PROCESSING CONTINUED… Chemical replenishment Chemical replenishment Rates inconsistent when processor left on and not used Rates inconsistent when processor left on and not used Check solution levels Check solution levels

36 PROCESSING: STANDARD Typically used for general radiography Typically used for general radiography Faster cycle time (usually 90sec) Faster cycle time (usually 90sec) Developer immersion ~23 sec Developer immersion ~23 sec Can accommodate single and double Can accommodate single and double

37 PROCESSING: EXTENDED Difference from standard is developer immersion time (~45sec) Difference from standard is developer immersion time (~45sec) “Push” more contrast and speed from the film “Push” more contrast and speed from the film Less exposure needed with increase in film speed Less exposure needed with increase in film speed Increase in tube life Increase in tube life Downfall is an increase in noise Downfall is an increase in noise

38 TYPES OF PROCESSORS Small desktop Small desktop DISADVANTAGES DISADVANTAGES Straight-through require careful adjustments to replenishment Straight-through require careful adjustments to replenishment Developer not sprayed evenly Developer not sprayed evenly ADVANTAGES ADVANTAGES Cost, small, fewer rollers, two developer stations, Cost, small, fewer rollers, two developer stations, Less chance of oxidation Less chance of oxidation

39 TYPES OF PROCESSORS Large stand-alone Large stand-alone DISADVANTAGES DISADVANTAGES Artifacts from rollers Artifacts from rollers Space Space ADVANTAGES ADVANTAGES Agitates chemicals which increases supply of fresh chemicals Agitates chemicals which increases supply of fresh chemicals

40 ARTIFACTS Processing Environmental Handling Positioning Equipment

41 SENSITOMETRIC STRIP Establishing the baseline Expose and process 5 strips Expose and process 5 strips Average readings for temporary base Average readings for temporary base Process one strip per day for 5 days Process one strip per day for 5 days If strip is out of tolerance, correct and repeat If strip is out of tolerance, correct and repeat Watch for trend due to seasoning effect Watch for trend due to seasoning effect Average these 5 strips for new base Average these 5 strips for new base Baseline maintained unless film, chemistry or processing altered Baseline maintained unless film, chemistry or processing altered

42 CROSSOVER Performed when changing box of film Performed when changing box of film sheets remaining in old box sheets remaining in old box Do not perform after processor cleaning Do not perform after processor cleaning

43 CROSSOVER PROCEDURE Perform in total darkness Perform in total darkness Expose 5 old and 5 new Expose 5 old and 5 new Alternate old and new Alternate old and new Distinguish old from new Distinguish old from new Measure steps used in daily QC Measure steps used in daily QC Average 5 readings from each box Average 5 readings from each box Subtract old from new Subtract old from new Add/Subtract results to/from original aim values Add/Subtract results to/from original aim values

44 CROSSOVER RESULTS Results must be within +/-.10 Results must be within +/-.10 If greater than.15 difference, contact film manufacturer representative If greater than.15 difference, contact film manufacturer representative

45 (Dudes Prefer) (Sex, Violence and Partying) over (Visiting) (Relatives For) (Christmas Day Feasts.) (Dudes Prefer) (Sex, Violence and Partying) over (Visiting) (Relatives For) (Christmas Day Feasts.)

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

48 QUALITY MANAGEMENT Part of the management function which determines and controls quality policy. Part of the management function which determines and controls quality policy. Making appointments Making appointments Call back protocol Call back protocol Obtaining previous mammograms Obtaining previous mammograms Patient education Patient education Patient intake Patient intake Problem solving Problem solving

49 QUALITY CONTROL The set of operations necessary to maintain or improve quality. The set of operations necessary to maintain or improve quality.

50 QUALITY SYSTEM Assignment of responsibility Assignment of responsibility Establishment of standards Establishment of standards Staff training Staff training Proper documentation of procedures Proper documentation of procedures QC of equipment at installation and throughout its life QC of equipment at installation and throughout its life

51 MQSA of 1992 As of Oct 1, 1994, all mammography facilities in the U.S. (except those of Dept of Veterans Affairs) were required to be certified by the FDA as meeting mammography quality in order to lawfully continue to perform Mammography. Goal: to assure that Mammography is safe and reliable to allow detection of breast CA in its earliest most treatable stages.

52 MQSA REGULATIONS To operate lawfully, a mammography facility must be certified by the FDA. To operate lawfully, a mammography facility must be certified by the FDA. In order to be certified, a facility must first be accredited by a federally-approved private nonprofit or state accreditation body. In order to be certified, a facility must first be accredited by a federally-approved private nonprofit or state accreditation body. To be accredited, the facility must undergo periodic review of clinical images; surveyed annually by a medical physicist; meet standards for personnel qualifications, equipment QA programs, and record keeping and reporting. To be accredited, the facility must undergo periodic review of clinical images; surveyed annually by a medical physicist; meet standards for personnel qualifications, equipment QA programs, and record keeping and reporting. Facility must undergo annual inspections. Facility must undergo annual inspections.

53 ACCREDITATION A survey form completed by facility A survey form completed by facility Phantom images submitted to evaluate image quality Phantom images submitted to evaluate image quality Dosimeter visible on phantom and dose measured Dosimeter visible on phantom and dose measured Clinical images submitted for evaluation Clinical images submitted for evaluation Once initial paperwork approved, facility submits 30 days of processor QC strips Once initial paperwork approved, facility submits 30 days of processor QC strips

54 CERTIFICATION Awarded by the FDA as providing quality mammography services. Awarded by the FDA as providing quality mammography services. This is awarded upon accreditation by a federally-approved accreditation body: ACR; States of Arkansas, California, and Iowa This is awarded upon accreditation by a federally-approved accreditation body: ACR; States of Arkansas, California, and Iowa

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56 RESPONSIBLE INDIVIDUALS TECHNOLOGIST TECHNOLOGIST RADIOLOGIST RADIOLOGIST PHYSICIST PHYSICIST

57 Interpreting Physicians Initial Qualifications State license State license Diagnostic radiology certification OR 3 months of formal training Diagnostic radiology certification OR 3 months of formal training 60 hours of category I CME in mammography 60 hours of category I CME in mammography 240+ mammograms interpreted under direct supervision 240+ mammograms interpreted under direct supervision  In the 6 months immediately prior to independent interpretation OR  If board certified at first allowable time, within the last 2 years of residency

58 Interpreting Physicians Continuing Requirements Continuing experience IIIInterpret at least 960 examinations / 24 months Continuing education AAAAt least 15 category I CME credits / 36 months AAAAt least 6 of the 15 CME units must be in each mammographic modality used 8 hours of training in each mammographic modality before independent use

59 Radiologic Technologists Initial Qualifications State license OR certified by FDA- approved body State license OR certified by FDA- approved body 40 hours of documented mammography training 40 hours of documented mammography training Performing at least 25 examinations under direct supervision Performing at least 25 examinations under direct supervision 8 hours of training in each mammographic modality to be used 8 hours of training in each mammographic modality to be used

60 Radiologic Technologists Continuing Requirements Continuing experience Continuing experience  At least 200 examinations / 24 months Continuing education Continuing education  At least 15 CEUs / 36 months  At least 6 of the 15 CEUs must be in each mammographic modality used 8 hours of training in each mammographic modality used before independent use 8 hours of training in each mammographic modality used before independent use

61 Radiologic Technologists Reestablishing Qualifications Continuing experience Continuing experience  Complete 25 examinations under direct supervision Continuing education Continuing education  Bring total continuing education credits up to 15 CEUs / 36 months

62 Medical Physicists Initial Requirements Licensed or approved by a State OR Certified by FDA-approved body Licensed or approved by a State OR Certified by FDA-approved body Master’s or higher degree in a physical science Master’s or higher degree in a physical science 20 semester hours of physics 20 semester hours of physics 20 hours of documented mammography survey training 20 hours of documented mammography survey training One facility and 10 units surveyed One facility and 10 units surveyed 8 hours of training in each modality surveyed before surveying independently 8 hours of training in each modality surveyed before surveying independently

63 Medical Physicists Alternative Initial Requirements* Licensed or approved by a State OR Certified by FDA-approved body Licensed or approved by a State OR Certified by FDA-approved body Maintained active status Maintained active status For physicists who were qualified under the interim regulations

64 Medical Physicists Alternative Initial Requirements* (cont.) Prior April 28, 1999, have: BBBBachelor’s degree in physical science with at least 10 semester hours of physics 44440 hours of documented mammography survey training after earning the bachelor’s degree OOOOne facility and 20 units surveyed after earning the bachelor’s degree

65 Medical Physicists Continuing Requirements Continuing experience Continuing experience  Survey at least 2 facilities and 6 units / 24 months Continuing education Continuing education  At least 15 CEUs / 36 months 8 hours of training in any modality before surveying independently 8 hours of training in any modality before surveying independently

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67 MANUAL QC MANUAL QC MANUAL QA MANUAL QA MANUAL

68 QA MANUAL Details of acceptance Details of acceptance Personnel qualifications and documentations. Personnel qualifications and documentations. Department policy Department policy Safety standards Safety standards Biohazards Biohazards

69 QC MANUAL The QC manual is pertinent to ease the inspection process. It lists: The QC manual is pertinent to ease the inspection process. It lists: Test procedures Test procedures Test frequencies Test frequencies Test standards Test standards Unacceptable results as listed as well as the corrections made for them. Unacceptable results as listed as well as the corrections made for them.

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