QC Pal
Quality Control Software
ESECO Speedmaster
730 ESECO RD
Cushing OK 74023
(800) 331-5904
(918) 225-1266
(918) 225-1284 (FAX)
Contents
Contents1
System Requirements2
Features3
Installation5
Daily Use6
Registration6
General operating information6
1st Time Startup7
Add A New Processor8
Read Reference9
Read Control9
Plot Control10
Diagnostics10
Define Schedule Tasks11
Daily Schedule Tasks11
Repeat Analysis12
Appendix A
Film Processing Test Procedures13
System Requirements
The QC Pal software comes on a CD.
It will run on Windows 95, 98, 2000, Me, NT, and XP.
5 Meg of free hard drive space is required.
Features
Quality Control for film processors
* Unlimited number of processors
* User defined processor limits
The user can define for each processor:
The processor name
Plot names (Contrast, Speed)
Action and operating limits
Steps to use
* Reference
Reference values are stored for each processor
These can be entered or read from a densitometer
* Crossover
Changing to a new batch of film is simple with automated crossover procedure
* Read Control
Daily readings are made and stored
* Control plot
View day to day variations of the control strip readings
* 21 Step plotting
View each day’s 21-step plot of the control readings
* Diagnostics
When the control plot is not within operating limits, Diagnostics will evaluate and suggest probable causes
Select “File, Print” to print whatever window is currently displayed
Quality Control for the lab
* Schedule Tasks
Periodic tasks can be scheduled.
The tasks are defined with a name, frequency and an optional reference value.
Daily, the task list is shown and any tasks that are overdue will be flagged.
This can be used for daily procedures.
Also, any other frequency can be used. (Monthly, 180 days, etc.)
Quality Control for X-ray procedures
* Repeat analysis
Maintain data for causes for repeated or discarded x-rays.
Enter the names of possible repeats. (Motion, too light, etc.)
Enter number of films for each reason and enter the total number of films.
The percentages for each item will display.
Installation
Insert the CD into the CD drive
It should automatically run the setup program.
If it does not automatically run, double click My Computer and select the CD drive. Double click “Setup” and the setup program will run.
Follow the on-screen instructions.
Selecting “Next” for each choice is the best way to quickly install it.
Both the QC Pal and SM-10T densitometer drivers will install.
A new Icon will be added to your desktop.
Daily Use
Registration
When the QC Pal is installed, it is started as a demo version. This demo will run a full-featured version for 21 days. Before the 21 days has expired, contact ESECO for your Register Key. This is a unique number for your computer that will allow the demo mode to end and the registered version to begin.
If you purchased the software just supply your name, company, and the USER-ID displayed in the “License Manager” window.
If you have not yet purchased the software, you will also need to supply payment information.
General operating information
Many of the common functions can be selected from the Tool bar on the right side of the screen.
All of the functions can be selected from the pull down menus across the top of the screen.
Generally, when you finish a function such as entering values, click the SAVE or OK button to close the window.
Some display windows can scroll through previous and next day data.
Diagnostics, View Ref/Control, View 21-step, and Schedule Tasks have arrows along the bottom of the screen that are used to scroll through the days.
1st Time Startup
The first time you run the QC Pal program, it will prompt with “1st time startup?”.
Click Yes.
The Help mode will be turned on which shows information about each function that you select.
The Communications setup screen will display. Select the com port that your densitometer is connected to. If you are not using the serial output on your densitometer, select “none”.
Select SAVE after the com port is selected.
The Preferences window will display. This includes the “License Manager” It should show that the 21-day demo started and there are 21 days remaining. It shows the USER-ID that you will provide to receive your Register Key. This window will display each time you start the program until the program is registered.
A processor named Startup is automatically created You can use this file for initial testing to view some of the functions that available.
Add A New Processor
Select File, Add New Processor.
Enter a name for the processor.
Usually the plot names, action limits, and operating limits are suitable. If needed, change these items to meet your requirements.
Enter the steps to use for each plot value. This is determined by processing and reading a film as described in Appendix A. Read this section carefully. Some of this information could vary depending on your installation or the state in which you reside.
After all information is entered on this screen, click ADD and the processor will be added.
Other than the processor name, all of this information can be changed later by selecting Edit, Processor Definitions.
Read Reference
The first time you establish reference readings, you can read 1 exposed film or you can read several films and average them. Select Reference Readings or Average from the Toolbar or from the pull down menu “Edit”
Read the 21 steps and enter the processor temperature. Select “Read Avrg 2” to read the next strip if averaging. Click OK when finished reading strips.
The reference readings that you just created can be viewed by selecting “View Ref/Control”.
A 21-step plot of these reference values can be viewed by selecting “View 21 step”.
These reference values will be used for each control strip that you read until another reference strip is entered or read.
Later, when a new batch of film is to be used, the crossover procedure is used to read some of the old batch, and some of the new batch. Typically, 5 films from the old and new are used. However, the reading procedure is flexible to allow any number of films.
Read Control
Select Daily, Read Control.
Read the 21 steps and enter the processor temperature. Click OK.
The Plot Control window will display automatically.
Plot Control
Select Daily, Plot Control.
A comment can be entered for the current day.
On the plot, each day that has a comment will show a “C” above the plot. Click on the “C” to see the comment.
When a plot is outside of the action limits, this is indicated by a red “*” under the plot.
If you read a control strip again on the same day, the subsequent strip will replace the first strip for that day.
Diagnostics
When a plot is outside of the action limits, you can select Diagnostics. This will display a list of probable causes for the out-of-control plot. A confidence factor is displayed that is a relative indicator of the closeness of the match of this plot to the plot definition data.
The first time Diagnostics is selected, the display will ask “Diagnostics first time. Create Diagnostics data file? C:\Windows\ESECODiag.txt” Select Yes and the data file for diagnostics will be created in the location indicated. This is a text file that you can edit if you want to add or modify defined processor problems. The data in the file contains documentation on the format of the data.
Define Schedule Tasks
You can define tasks that should be done periodically.
Select Edit, Define Schedule Tasks.
Enter the Task name for up to 10 tasks. Enter the frequency of occurrence in days.
If there is a reference value associated with this task, such as room temperature, check the Ref box, enter the reference value and a high and low value for the action limits on a plot.
Click Defaults to automatically enter some predefined tasks. These can be cleared if they do not meet your needs.
Click Clear to clear all fields and start over.
Daily Schedule Tasks
Each day select Daily Schedule Tasks.
From this screen you indicate that you performed the task by entering your initials in the “Initials” field. If there is a value associated with the task, enter it here also.
The Task screen displays and indicates if any tasks are over due.
The number of days overdue is shown in red.
If there are tasks that can be plotted (reference values used) you can click Plot or Plot Next to view the graph.
Repeat Analysis
Repeat analysis allows you to maintain up to 3 databases of information about repeated and discarded films.
Select Tools, Repeat Analysis.
To set this up initially, select 1 of the 3 data sets. Enter a description name for the data set. This could be a lab name and a range of dates, i.e. “Main Lab Jan – Mar 2003”.
Enter the repeat reasons that could be causes for films to be repeated or discarded.
Enter the total films for the period.
Enter the number of films repeated or discarded for each reason.
The display constantly updates the percentages as data is entered.
Click SORT to view the list sorted by percentage.
The data is automatically saved when you select another data set or exit this window.
Appendix A
Film processing test procedures
Automatic Film Processors
Processing conditions must be tested before processing patient films or at least once per week. The test consists of exposing film to a known intensity of light, processing the film and comparing the film to a known standard. Under processed or over processed films can lead to misdiagnosis, excessive patient exposure and increased operating costs. Properly exposed and processed films are required for proper patient care. Over exposing the patient to radiation and under processing the film is a serious problem.
There are two methods that may be used for this testing:
A. Sensitometer/densitometer
B. Penetrometer
Put fresh chemistry into the processor and mix fresh chemistry for the replenishment tanks if provided. For small tabletop processors, operate the processor for two days to season the chemistry. For larger processors, operate the processor for five days. Seasoned chemistry is more stable than fresh chemistry and will give a more consistent test result. Seasoning requires about 5 14"x17" equivalent films for small processors and 25 for larger processors.
A. Sensitometer/densitometer method.
1. A sensitometer is a device designed to expose one or both surfaces of the film to a preset light source, imprinting an image of graduated density steps on the film.
2. A densitometer is a device designed to pass light through the processed film and measure the intensity of the light as it passes through the graduated density steps on the processed film.
3. By charting the density of specified steps, the operator can determine whether the processor has changed since the last test. If the processor has changed by more than an acceptable amount, usually one step on a 21-step sensitometer or 0.15 density, then a determination of the cause of the change needs to be made before patient films can be processed. A processor must be within control specifications established by the test procedure before patient films are processed.
4. Establishing a correct baseline is critical to the proper testing. The following steps can be used to establish your baseline charts:
a.Needed tools:
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1. Thermometer. This should be a non-mercury thermometer, either electronic or dial type capable of determining temperature of the developer to within 0.5 degree F. A common fever thermometer can be obtained at any variety store. These have sufficient range and accuracy to be used for testing the processor developer temperature. Thermometers in processors are seldom accurate or consistent. You need to verify the actual temperature and make adjustments accordingly.
2. A simulated light source (sensitometer) that is capable of exposing the film using either blue or green light.
3. A densitometer to measure density of the film.
4. Quality control film. This box of film should be used exclusively for quality control. It must be the same type of film you use for your patient exams. If you routinely use only 14X17 film, the QC film may be 8X10 so long as it is the same type of film. Also, film is either blue sensitive or green sensitive, depending on the type of screens you use in your cassettes. You must use film that is compatible with your screens for proper exposure. If you do not know what screens you have, contact your x-ray service supplier.
5. Processor quality control charts. These charts are useful tools for graphically plotting the QC values and determining trends or out of control values. Charts generally come with the QC kits and a sample is attached to this packet.
b. The sensitometer is used to expose your test film.
1. Set the “blue/green” switch to the type of film you are using. In the darkroom with the lights off, insert the edge of the film into the slot on the sensitometer. Some are a “clam shell” design and you press the top down onto the film to activate the light source. Rotate the film 180 degrees and expose the opposite edge of the film.
2. Some films are more sensitive on one side of the film and exposing opposite sides will invalidate the results. Turn the film over and expose the ends of the film rather than the long edges, if one side of the film differs significantly from the other. Always use the same side to measure the density. You can choose the high reading side or the low reading side but you must be consistent. You must always use the same side of the film for testing. Always orient the film box the same way when removing the film. Mark one side to the box with a heavy marker and always keep that side up or down when removing the film from the box.
3. Process the film by placing the film on the feed tray. Always place the film on the same side of the feed tray and always have the same side of the film facing up. Sensitometry films must be processed each day for five days to establish your “Aim Points”.
4. When the film comes out of the processor, measure the density as follows:
a. Measure the density of the steps numbers 8 to 14 on each of the exposed strips on each film. Record the values and average the value for each film at each density step.
b. Add the five values for each film on each step and divide by five to obtain the average for all five days.
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c. Determine which step will be used for the speed or Mid Density (MD) value by selecting the step that is closed to a density value of 1.20 but not less than 1.10. This can be over1.20. Plot this point on the chart at the MD line and write this value on the chart.
d. Next, select the density steps that will be used to determine the contrast or Density Difference (DD) value. Select the density step with a value of not more than 2.20. Then, select the density step with a value of not less than 0.45. Subtract the lower value from the higher value to determine the DD. Record the density step numbers and the density difference on the chart on the line that represents the operating level for contrast.
e. Measure the base plus fog value by measuring the density in an unexposed portion of the film. If this value exceeds 0.23, you may have a darkroom fog problem with light leaks or improper safe lights.
f. Establish control limits for speed (MD), contrast (DD) and base plus fog. For the MD and DD values, the range should be +/- 0.20 density and for base plus fog should be no greater than 0.03.
g. Developer temperature can also be plotted on the charts.
Once the chart has been established, each test film must be plotted on a QC chart before the patient films are processed for that day. If the processor is “out of control”, determine the cause and correct the problems before processing the patient film. This may require adjusting the temperature or adding fresh chemistry. Small tabletop processors are more prone to fluctuations than larger models. Write the date of each test on the chart. QC films need to be processed only on days when patient films are being processed.
B. Penetrometer method (Step-Wedge)
Tools needed
1. Penetrometer
2. Thermometer
3. Densitometer (preferred but not required)
This test method may be used but is not the preferred method. A densitometer should also be acquired to measure the base plus fog values to determine whether there are any light leaks in the darkroom. If inspection results by the department inspectors show that this method is ineffective, facilities will be required to obtain the test tools for the sensitometer/densitometer method.