Procedure: Validation and Calibration of Equipment
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Policy QEQMI02002.11 Page 1 of 3 Department of Microbiology Quality Manual Section: Equipment Subject Title: Equipment Validation Procedure Prepared by: QA Committee Original Date: December 22, 2003 Issued by: Laboratory Manager Revision Date: Approved by: Laboratory Director Annual Review Date: May 31, 2013
Purpose: The objective is to ensure an optimal working instrument providing accurate qualitative and/or quantitative results prior to implementation. Validate and calibrate all equipment used in the department. This will be done on site prior to implementation of the item to ensure that it meets the manufacturer’s performance claims. Where possible the department will use control material of known values for calibration and quality control of the instruments. Commercial control material will be used when available. If commercial control is not available, known positive and negative material will be used.
Procedure: 1. All tests on the instrument should be validated on newly acquired instruments before they are placed into routine use. 2. A validation study will be performed to compare results with the existing methodology where applicable. 3. The number of samples used for validation depends on: the manufacturer’s recommendation regulatory guidelines such as NCCLS, QMPLS, CAP the prevalence of the disease the availability for an external validation panel 4. All validation test runs will include external and internal controls. 5. Samples with discrepant results will be sent to a Reference Laboratory for further investigation. 6. The acceptance of the new method/equipment/instrument depends on the review of all comparison results.
UNIVERSITY HEALTH NETWORK /MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
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D:\Docs\2017-12-16\060ae20cde52fbd24139d26dcac5c7ae.doc Policy QEQMI02002.113 Department of Microbiology Quality Manual Section: Equipment Subject Title: Equipment Validation Procedure
7. Instruments that have undergone repairs and preventive maintenances should be re-validated by running both external and internal controls. These controls must fall within the acceptable limits. Test LIS interface if applicable. 8. Embedded software updates must be validated according to the manufacturer’s instructions. The LIS officers must be informed of all such updates so that they can validate results sent through all interfaces.
UNIVERSITY HEALTH NETWORK /MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked against the document (titled as above) on the server prior to use.
D:\Docs\2017-12-16\060ae20cde52fbd24139d26dcac5c7ae.doc Policy QEQMI02002.113 Department of Microbiology Quality Manual Section: Equipment Subject Title: Equipment Validation Procedure
Record of Edited Revisions
Manual Section Name: Equipment
Page Number / Item Date of Revision Signature of Approval Annual Review March 1, 2004 Dr. T. Mazzulli Annual Review March 1, 2005 Dr. T. Mazzulli Annual Review July 23, 2006 Dr. T. Mazzulli Annual Review April 26, 2007 Dr. T. Mazzulli Annual Review June 16, 2008 Dr. T. Mazzulli Annual Review June 16, 2009 Dr. T. Mazzulli Annual Review June 11, 2010 Dr. T. Mazzulli Annual Review May 31, 2011 Dr. T. Mazzulli Annual Review May 31, 2012 Dr. T. Mazzulli Annual Review May 31, 2013 Dr. T. Mazzulli
UNIVERSITY HEALTH NETWORK /MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY
NOTE: This is a CONTROLLED document. Any documents appearing in paper form that are not stamped in red "MASTER COPY" are not controlled and should be checked against the document (titled as above) on the server prior to use.
D:\Docs\2017-12-16\060ae20cde52fbd24139d26dcac5c7ae.doc