KonicaCR数位乳房影像及X光摄影仪品质保证校验纪录表.docx

Konica CR數位乳房影像及X光攝影儀品質保證校驗紀錄表
A.日常性(非年度)品質保證作業每週、每季及每半年實施:
1.每日乳房攝影數位影像系統檢查(Daily Operational Checks)(RTQm-1).………….….2
2.假體影像品質控制表(Phantom Image Quality Chart) (RTQm-2)………….………...…3
3.影像板片匣檢視與清潔紀錄表(Image Cassette and Plate Check) (RTQm-3).…………4
4.影像顯示器與閱片箱清潔紀錄表(Monitor and Viewbox Check Chart) (RTQm-4)…...5
5.系統設備檢查與清潔品管表(Visual Inspection Chart) (RTQm-5)…………………..…6
6. 乳房攝影品管清單(A) (RTQc-1a)、(B) (RTQc-1b) ……………………………….…...7、8
7.重照影像紀錄表、分析表(Repeat Analysis Chart) (RTQm-6a、RTQm-6b)……....…9、10
8.壓迫力測試表(Compression Force Test Chart) (RTQm-7)………………..…………...11
9. 每季每半年乳房攝影品管清單(RTQc-2) ……..…………………………………...…12
B.定期性(年度)品質保證作業每年實施:
10.房攝影單元組件檢查表(Physical Inspection Chart) (MPQm-8)………….…….…....13
11.暗雜訊評估表(Dark Noise Check Chart) (MPQm-9)……………………….….….…14
12.殘影評估(Ghost Image Evaluation Chart) (MPQm-10)….…………………….….…..15
13.管電壓準確性與再現性評估(kVp Accuracy and Reproducibility Evaluation
Chart) (MPQm-11) ……………………………………………………….….…….....16
14.自動曝光控制效能評估表(AEC Performance Check Chart) (MPQm-12)…........…...17
15.系統假影評估表(System Artifact Evaluation Chart) (MPQm-13)…….…….….…….18
16.影像板感光均勻度評估表(Image Plate Response Uniformity Check Chart) (MPQm-14)……………………………………………………………..……….....…..19
17.影像顯示器品質管制表(Monitor Quality Control Chart) (MPQm-15)……..………..20
18.印像機品質管制表(Printer Quality Control Chart) (MPQm-16)…………….…….…20
19.閱片裝置及閱片環境評估表 (ViewBoxes and Viewing Condition Evaluation Chart) (MPQm-17)……………………………………………………...….…………..20
20.解析度評估表(Spatial Resolution Evaluation Chart) (MPQm-18)…..………….….…21
21.假體影像品質評估表(Phantom Image Quality Chart) (MPQm-19)……………….…22
22.幾何失真測試表(Geometric Distortion Check Chart) (MPQm-20)….…………..…...23
23.S值對應顯示測試(S-Value Response Indicator Check Chart) (MPQm-21)…….……24
24.準直儀狀況評估(Collimator Assessment Check) (MPQm-22)……………………….25
25.射束品質的評估及半值層測定表(Beam Quality Evaluation and HVL
Measurement) (MPQm-23)…………………………………………………...……....26
26.乳房入射曝露、自動曝露控制的再現性、平均乳腺劑量和輻射輸出評估 (MPQm-24) …………………….……………………………………………...……....27

品質保證校驗紀基本資料

一、數位影像系統︰
　　　製造廠商︰Konica-Minota 型號︰ ___________________

二、X光攝影儀︰
　　　 製造廠商︰ 　　　　　　　　 型號︰ ___________________

三、影像顯示器︰
　　　製造廠商︰ 　　　　　　　 　 型號︰ ___________________

四、印相機︰　　　
製造廠商︰ 　 　　　 型號︰ ___________________
每日乳房攝影數位影像系統檢查(Daily Operational Checks) ( RTQm-1)
Site: Date:
Equipment:
X-ray unit manufacturer /Model :
( Frequency: Daily)
A . X-ray Unit Evaluation
Pass
Fail
1
Free-standing unit is mechanically stable

2
All moving parts move smoothly, without obstructions to motion

3
All locks and detents work properly

4
Image receptor holder assembly is free from vibrations

5
Image receptor slides smoothly into holder assembly

6
Image receptor is held securely by assembly in any orientation

B. CR Control Area Evaluation
Pass
Fail
7
CR Acquisition Monitor is free of blemishes and

8
REGIUS login screen is displayed and no errors are reported

9
No errors are displayed on the R190 Reader

10
Technique chart is in place

11
Exposure switch is in place

C. Imaging Cassettes and Plates (Place the R190 Reader into “Deep” erase mode)
Pass
Fail
12
Insert each cassette into the Reader for erasure

13
Following erasure the cassettes should be stored in a radiation shielded location to prevent fogging of the imaging plate from scatter radiation

Performance Criteria:
All evaluation items are met.
All Cassette are returned.

Comments:

假體影像品質控制表(PHANTOM IMAGE QUALITY CHART )(RTQM-2)

影像板片匣檢視與清潔紀錄表(Image Cassette and Plate Check)(RTQm-3)
廠牌︰____________________型號︰_______________________年份 ___________________年 (實施頻率:每週)
Date
IP# 1
IP# 2
IP# 3
IP# 4
IP#5
IP#6
IP#7
IP#8

Performance Criteria: All evaluation items are met.

改善措施:

影像顯示器與閱片箱清潔紀錄表(Monitor and Viewbox Check Chart) (RTQm-4)

廠牌︰____________________型號︰_______________________年份 ___________________年 (實施頻率:每週)
Date
　 　 Radiologist’s Monitor
CR Console
Viewbox
Ｍonitor 1
Monitor 2
Monitor 3
Monitor 4
Monitor
Viewbox 1
Viewbox 2

Performance Criteria: All check items are met.

改善措施:

系統設備檢查與清潔品管表(Visual Inspection Chart) (RTQm-5)

X-ray Unit: CR Model:_ _ Year:_ (Frequency: Monthly)
Month
1
2
3
4
5
6
7
8
9
10
11
12
Date

Initials

Gantry:
Angulation Indicator

Locks (all)

Field Light

Smoothness of motion

Inspect all paddles for cracks

Control Panel:
Switches/indicators

Display

Technique charts

Cleaning:
X-rayUnit

All Image Plate

Monitors

View Boxes

Pass: P Fail: F Dose not Apply: N/A

Performance Criteria: All inspection items are met.

Comment:

乳房攝影品管清單（A）

每日/每週檢視 (RTQc-1a)

乳房攝影品管清單（B）
每月檢視(RTQc-1b)

重照影像紀錄表(Repeat Analysis Chart-a)(RTQm-6a)

重照影像分析表(Repeat Analysis Chart-b) (RTQm-6b)

壓迫力測試表(Compression Force Test Chart) (RTQm-7)

X-ray Unit Brand/Model：___________________________ (Frequency: Semi-Annual)
Date
Auto (11.4-20.4 kg)
Manual (11.4-20.4 kg)

Pass
Fail
Pass
Fail

Remarks

Date
Action

每季每半年乳房攝影品管清單 (RTQc-2)
Quarterly/Semi-Annual Record of Check
Year
Month

Date

Initials

Repeat Analysis

Compression

Auto

Manual

Manual

Radiologist Review

Physicist Review

Comments:

乳房攝影單元組件檢查表(Physical Inspection Chart) (MPQm-8)

Site: Date:
Equipment:
X-ray unit manufacturer /Model :

Mammographic Unit Assembly Evaluation
Pass
Fail
1
Free-standing unit is mechanically stable

2
All moving parts move smoothly, without obstructions to motion

3
All locks and detents work properly

4
Image receptor holder assembly is free from vibrations

5
Image receptor slides smoothly into holder assembly

6
Image receptor is held securely by assembly in any orientation

7
Compressed breast thickness scale accurate to ±0.5 cm, reproducible to ±2mm

8
Patient or operator is not exposed to sharp or rough edges, or other hazards

9
Operator technique control charts are posted

10
Operator protected during exposure by adequate radiation shielding

11
All indicator lights working properly

12
Auto -decompression can be overridden to maintain compression (and status displayed)

13
Manual emergency compression release can be activated in the event of a power failure

14
Collimator Light >160 Lux

15
Compress Force 11.4-20.4kg

Performance Criteria: The unit is stable. All mechanical movements should be smooth and normal.
Lock and release mechanisms operate properly. Compression thickness display is accurate within 0.5cm
of true value. Operator and patient safety are preserved during normal operation. All lights, indicators,
and audio signals function properly. Patient Surfaces are clean and free from of excessive wear. No errors
are displayed on the unit

Comments:

暗雜訊評估表(Dark Noise Check Chart) (MPQm-9)

Konica CR Reader型號：___________年份__________年 (實施頻率:每年)
影像板片匣編號
(IP#)
Displayed 5000 S-Value
改善措施
Dark Noise 1
Dark Noise 2
Pass
Fail
Pass
Fail

Performance Criteria: The acquired image should display an ‘S’ value of 5000.

Comments:

殘影評估表(Ghost Image Evaluation Chart) (MPQm-10)

kVP: mAs:
Konica CR Reader型號：___________年份__________年 Phantom Model: (實施頻率:每年)
影像板片匣編號
(IP#)
Dark Noise2
無潛像(Y/N)
Invisible Ghost Image
改善措施
　Pass
　Fail

Performance Criteria: The Dark Noise2 image should be free of any latent image. There should
be no imaged object pattern recognizable from the erase 1 image present in the erase 2 image.

Comments:

管電壓準確性與再現性評估(kVp Accuracy and Reproducibility Evaluation Chart）
(MPQm-11)
　　kVp測量儀廠牌/型號：_____________________IP# (實施頻率:每年)
Nominal kVp 設定

準則
Focal spot　大小

Exposure time(秒)

mA

mAs

測量kVp值：
1

2

3

4

平均kVp

標準差(SD)

% Error

≦±5%
CV(SD/平均kV)

≦0.02
Additional kVp measurements (if needed)
5

6

7

8

9

10

Recalculated:
平均kVp

標準差(SD)

平均kVp-Nominal kVp

0.05 X Nominal kVp

% Error

≦±5%
CV(SD/平均kV)

≦0.02

Action Limit: If the mean kVp differs from the nominal by more than ±5% of the nominal kVp,
or if the coefficient of variation exceeds 0.02, then seek service correction.

自動曝光控制效能評估表(AEC Performance Check Chart) (MPQm-12)

AEC Sensor Position:
Stability and Reproducibility
Image Model: Small Receptor(Bucky)
Focal Spot: Large
mA:
Phantom Thickness
IP #
AEC Model
Target/Filter
Density Control
mAs
mR
S-Value

Exposure 1

Exposure 2

Exposure 3

Exposure 4

Average

SD

CV

Criteria: The coefficient of variation should be ≤ 5% for mAs and mR.

Phantom Thickness
IP #
AEC Model
Target/Filter
Density Control
S-Value

2 cm

4cm

6cm

Sav

Smax-Smin

Sv

Sv=〔(Smax-Smin)/Sav〕x100%

Criteria: Sv should be ≤ 20%

Comment:

系系統假影評估表(System Artifact Evaluation Chart) (MPQm-13)

Attenuator規格 :
Attenuator厚度:
kVp設定:
Density control 設定:
X光機廠牌：_______________________型號：________________年份 ______年 (實施頻率:每年)
Image receptor size
　18x24cm
24x30cm

陽極靶(Target)

濾片(Filter)

焦點(Focal spot)

Film OD

有可見的Artifacts ?

Hard Copy 洗片機?

Hard Copy 印像機?

可接受的?

敘述

CR 影像板

可接受的?

敘述

X-ray儀器?

可接受的?

敘述

ACTION LIMIT:
如果假影足影響臨床影像診斷品質，則在未排除或改善以前該設備應停止使用，
並聯絡相關廠商處理。

影像板感光均勻度評估表(Image Plate Response Uniformity Check Chart)
kVp: (MPQm-14)
Konica CR Reader型號：___________年份__________年 Phantom Model: (實施頻率:每年)

IP #
mAs
OD
S-Value
≦15% of S average
改善措施
Pass
Fail

Average

Criteria: The reported S value of the individual images should be with in +/- 15% from the mean value

Comments:

影像顯示器品質管制表(Monitor Quality Control Chart) (MPQm-15)
廠牌：____________________型號：_______________________年份 ___________________年 (實施頻率:每年)

　　Radiologist’s 影像顯示器

Ｍonitor 1
Monitor 2
Monitor 3
Monitor 4

影像顯示器雜訊條紋
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

影像顯示器閃爍
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

影像顯示器陰影
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

黑白對比可辨識
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

0%小方形區5%灰階可辨識
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

100%小方形區95%灰階可辨識
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

最大亮度值符合廠商規格
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

亮度理想值符合廠商規格
Y　Ｎ
Y　Ｎ
Y　Ｎ
Y　Ｎ

原製造廠商QA程序執行

Performance criteria: 5% and 95% grayscale patches should be visible

印像機品質管制表(Printer Quality Control Chart) (MPQm-16)
廠牌：____________________型號：_______________________年份 ___________________年 (實施頻率:每年)

　數值
Pass
Fail
　　 改善方法
最大光密度值(Dmax)

最小光密度值