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Microscan QC and Maintenance

By Diane Reed,2014-05-19 23:59
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B. New lots of MicroScan developer chemicals will be subjected to quality control checks prior to use for patient isolates

    Combat Support Hospital

    Clinical Microbiology, Baghdad, Iraq

    Dade MicroScan System QC and Maintenance

1. PRINCIPLE:

     The goals of Quality Control and Maintenance of the MicroScan system components are:

     A. Ensure proper performance of the antimicrobial agents, substrates, and developer chemicals used for unknown

    clinical isolates.

     B. Ensure precision and accuracy of the autoSCAN-4 instrument.

     C. Ensure proper function of the RENOK inoculation device and other devices used with the MicroScan system.

     D. Ensure reliability and retrieveability of identification and susceptibility data.

2. MICROSCAN QC AND MAINTENANCE POLICIES:

     A. New lots of MicroScan Combo plates will be subjected to quality control checks prior to use for patient isolates

     B. New lots of MicroScan developer chemicals will be subjected to quality control checks prior to use for patient

    isolates

     C. Whenever possible, only unexpired Combo panels and developer chemicals will be utilized. If no in-date Combo

    panels or developer chemicals are available, the New Lot and Monthly quality control procedures outlined

    below will be performed weekly.

     D. Day of use and weekly maintenance procedures will be performed as outlined below.

     E. Refer to the LabPro Manual, Sections 4, 6, and 11 and the autoSCAN-4 Service Manual for additional information

    and procedures

3. DAY OF USE QC AND MAINTENANCE:

     A. QC Diagnostics

     1) After you have loaded a panel into the panel block of the autoSCAN-4 instrument drawer, a dialog box pops

    up prompting the operator to perform QC Diagnostics. Click on the QC Diagnostics button.

     2) The QC diagnostics performed automatically by the autoSCAN-4 are:

     a) PROM Checksum a test that checks for a corrupted reader program. Failure of this test indicates

    that the CPU board needs to replacement.

     b) RAM Memory Check All panel data gathered by the CPU is temporarily stored in RAM before

    being sent to the PC. The autoSCAN-4 RAM must be working properly for panel analysis. Failure of

    this test indicates that the CPU board assembly needs replacement.

     c) Power Supply Voltages confirms that the voltages generated are at their proper rating

     d) Light Source tests whether the lamp is functional or is burned out

     e) A/D Photoboard tests the function of the A/D and photoboard including gain, offset, and slope.

     f) Color Wheel checks the function of the color wheel including advancement from filter to filter,

    homing, and continuous motion

     g) Drawer Motion checks for proper function of the drawer assembly including open/closed status,

    optical interruption when drawer is open, and continuous motion

     3) Fan check listen to make sure the fan is operating.

     B. Calibration

     NOTE: calibration must be performed every 24 hours or whenever the autoSCAN-4 is turned off

     1) Checks the wavelengths of the individual filters used for reading the MicroScan panels

     2) Click on the Calibrate button to begin the operation

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     C. After you have performed both the QC Diagnostics and Calibration, print a copy of both reports. Review printout

    for error messages. Only proceed with patient unknowns if both diagnostics were successful. If either report

    indicates and error, exit the Lab Pro system, turn off the autoSCAN-4 briefly, then back on. Repeat diagnostics and

    calibration.

4. WEEKLY MAINTENANCE:

     A. Clean the Diffuser Plate

     1) Remove the drawer front plate

     2) Remove metal clips on the panel block that retain the diffuser plate. Note that the clips are mirror images of

    each other and are not interchangeable.

     3) While wearing gloves, remove the diffuser plate. Clean the smooth side of the plate with alcohol. NOTE: a

    scratched or stained diffuser plate MUST be replaced.

     4) Replace the clean diffuser plate, making sure that the notched end is in the right, rear position

     5) Replace the retaining clips. Make sure that the clips hook over the front of the panel block

     NOTE: It is very important not to get grease, oil, or fingerprints on the diffuser plate always wear gloves

    when handling the plate

     B. Clean the Photodiode Shield

     1) Turn off the autoSCAN-4

     2) Open the unit cover and push the plate drawer in slightly

     3) While wearing gloves, slide the shield out towards you. Clean the plate with alcohol. NOTE: a scratched

    or stained photodiode shield MUST be replaced

     4) Replace the shield so that the front of the shield is flush with the front of the instrument.

     5) Close the instrument cover

     NOTE: It is very important not to get grease, oil, or fingerprints on the photodiode shield always wear

    gloves when handling the shield

5. NEW LOT AND MONTHLY QUALITY CONTROL:

     NOTE: see Appendix for QC organism stock maintenance

     A. MicroScan Gram-Positive Breakpoint Combo 20 Panels

     1) For every new lot prior to use and at least monthly, the MicroScan Gram-Positive Breakpoint Combo 20

    panels will be tested for appropriate function using the following organisms:

     a) S. aureus ATCC 29213

     b) E. faecalis ATCC 29212

     c) S. bovis ATCC 49147

     d) M. luteus ATCC 49732

     2) Testing these 4 organisms provides quality control checks for the panel substrates and antimicrobial agents

    and for the developer chemicals

     B. MicroScan Gram-Negative Breakpoint Combo 30 Panels

     1) For every new lot prior to use and at least monthly, the MicroScan Gram-Negative Breakpoint Combo 30

    panels will be tested for appropriate function using the following organisms:

     a) E. coli ATCC 25922

     b) P. aeruginosa ATCC 27853

     c) K. oxytoca ATCC 49131

     d) P. vulgaris ATCC 49132

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     2) Testing these 4 organisms provides quality control checks for the panel substrates and antimicrobial agents

    and for the developer chemicals.

     C. Procedure

     1) Updating Developer Chemical Lot Numbers

     a) On the Command Center, click QC Order Entry

     b) On the QC Order Entry Read menu, click autoSCAN-4/Manual Reagent Lot Numbers

     c) Position the pointer in the appropriate reagent box and type the new lot number. Repeat this step to

    add or edit additional reagent lot numbers.

     d) Click OK to save the new reagent numbers and return to the QC Order Entry window

     2) Add a New QC Order

     a) On the Command Center, click QC Order Entry icon and the QC Order Entry window appears.

     b) Type the lot number in the Lot # box, and press Enter.

     1] If the lot number does not exist, the pointer positions in the Panel Type box

     2] If a matching lot number is found, the information for that lot appears

     3] If you want to add a new QC order for the same lot with a different received date, click New

    Lot/Shipment

     4] If more than one QC order with the same lot number is found, the Duplicate Lot Numbers

    dialog box appears. Select the desired lot number or click New Lot/Shipment to add a new

    QC order with the same lot number.

     c) In the Panel Type box, type the panel code and press the Tab key or click the Panel Type Lookup

    button. Double-click a panel in the Test Groups table and press the Tab key.

     d) In the Received Date box, type the date the panel shipment was received or click the Calendar

    button and then double-click a day

     e) Click Save

     3) Add QC Organisms

     a) Click on Identification and MIC Test Battery in the QC Order area, and then click Accept Order

    on the toolbar (angled Petri dish with a checkmark icon)

     b) LabPro creates an isolate for each organism in the selected test battery and adds the isolates to the QC

    Isolate/Order list. NOTE: If a test battery in the QC Order area is unavailable, test batteries have not

    been customized for the panel type. See the LabPro Manual, Administrator’s Guide, for detailed

    procedures on how to add a QC test battery.

     c) Click an isolate to select it, and then click autoSCAN-4 Read

     4) Print QC Results

     a) On the Command Center, click the QC Review and Edit icon. The QC Review and Edit Search

    window appears.

     b) In the Search Type area, click Lot #

     c) Click on the drop-down list to select the desired lot number

     d) Click on the Find icon (binoculars)

     e) In the QC Isolates for Lot# list, select the isolates (click while holding Control) and click Print

6. LABPRO DATABASE BACKUP

     A. It is important to backup the LabPro Database file. Frequently backing-up the patient and QC information in the

    database will prevent loss of this data in the event of hard-drive or other PC failure.

     B. Database backup should be performed at least bi-weekly using the Zip drive included with the MicroScan system

    PC

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     C. Procedure

     1) Close all LabPro applications except the Command Center

     2) Insert the backup disk into the Zip drive

     3) Click Utilities on the Command Center, and the Utilities window appears

     4) Double-click System, and then double-click Backup. The Backup dialog box appears

     5) Check the Destination box. Make sure that the external Zip drive is specified

     a) To select a different drive, click the Destination Browse button (…). Double-click the appropriate

    items until the drive and directory you want displays in the Save in: box.

     b) Click Save

     6) Click Backup

     7) When you finish backing up the database, click Close

     8) On the Utilities window, click the Close button

     9) Remove the Zip disk from the drive

     D. Alternate procedure

     1) Close all LabPro applications except the Command Center

     2) Insert the backup disk into the Zip drive

     3) Double-click on My Computer

     4) Double-click on LabProData (D:)

     5) Double-click on the MicroScan folder

     6) Double-click on the LabPro folder

     7) Right click on the DSMNT.GDB file and select Copy

     8) Use the Back button until you return to the My Computer window

     9) Double-click on the Removable Disk (E:) drive

     10) Right click anywhere in the Zip drive window and select Paste

     11) The popup message “This folder already contains a file named „DSMNT.GDB‟. Would you like to

    replace the existing file?” Click on the Yes button.

7. REFERENCES:

     A. Operator’s Guide, MicroScan LabPro Manual. Dade Behring, 9020-6656, Revision A, 2002.

     B. Administrator’s Guide, MicroScan LabPro Manual. Dade Behring, 9020-6656, Revision A, 2002.

     C. MicroScan autoSCAN-4 Service Manual. Dade Behring, 9020-6468, Revision A, 1999.

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Appendix. QC Organism Stock Maintenance

1. PRINCIPLE:

     Microorganisms may lose certain biochemical properties when repeatedly sub-passaged in vitro. The loss of these

    properties may result in aberrant phenotypic and antimicrobial susceptibility results when used for quality control checks. To

    maintain fresh, metabolically robust QC organisms, use one of the procedures below.

2. SUPPLIES AND EQUIPMENT:

     A. Culti-Loops lyophilized microorganisms store at 4C until the expiration date

     B. Blood agar or Chocolate agar plates

     C. Sterile inoculating loops

     D. 35-37C incubator

3. PROCEDURE:

     A. Recovery of Lyophilized Stocks

     1) Warm the required number of blood agar plates by placing in a 35C incubator for 1 hour

     2) Remove a Culti-Loop from its foil package and then remove the red sheath from the loop

     3) Lay the loop flat on the warm agar surface for 10-15 seconds, pressing gently onto the surface of the media.

    Rehydration of the loop will appear as a clear bead of moisture upon lifting the loop from the agar. NOTE:

    The black film does not have to completely dissolve from the loop for growth of the organism to occur.

     4) Streak for isolation. Incubate plate(s) at 35C for 18-24 hours

     5) Pass the organism to a second blood agar plate and incubate overnight. The organism is now ready for use

    in QC procedures.

     B. Maintenance of QC Organisms follow steps A.1)-5) above each time a QC operation is to be performed

4. REFERENCES

     A. Culti-Loops package insert. CHRISOPE Technologies, Revision 10/97. nd B. Isenberg, Henry D. ed. Clinical Microbiology Procedures Handbook, 2 edition. ASM Press, Washington D.C.,

    2004. pages 14.2.21-14.2.23.

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