Department of Microbiology
Quality Manual
Section: Request and Notification of LIS Changes
Prepared by: LIS Committee
Issued by: Laboratory Information System
Approved by: Laboratory Director
Policy QIMMI03004.09
Page 1 of 3
Subject Title: Auto-verification of
Results in Soft
Original Date: January 21, 2004
Revision Date: November 3, 2008
Annual Review Date: May 31, 2013
PURPOSE: To describe the Auto-Verification of results Policy for the Soft Modules.
PROCEDURE:
1. Auto-verification (i.e. without the intervention of technologists) is a feature of
the LIS that enables the system to automatically verify testing results. Results
must be within normal ranges and must not exceed panic or absurd ranges
and/or must not be accompanied by any abnormal instrument flags.
2. A selection of any of these criteria can be made on an individual instrument
basis.
3. Normal ranges, unique to the instrument and methodology used, are
determined by the medical professional staff and based on literature review.
4. Results once auto-verified are ready to be released to the referring physicians.
5. The LIS Officer is responsible for ensuring that the mechanism for accuracy of
auto-verification is tested annually.
6. Documentation for annual testing of auto-verification will be kept on file.
7. The auto-verification policy must be reviewed, approved and documented
annually by the Pathologist-in-Chief and Director of Pathology and Laboratory
Medicine/ Microbiologist-in-Chief or designate.
8. If changes are made to the auto verification rules after initial testing and
documentation, the process is re-verified as to its accuracy.
9. Upon notification of a problem with either test method, analytic instrument or
the autoverification program, an LIS officer may immediately suspend the
autoverification program.
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:\533568930.doc
Department of Microbiology
Quality Manual
Section: Request and Notification of LIS Changes
Policy QIMMI03004.09
Page 2 of 3
Subject Title: Auto-verification of Results in
Soft
Related Documents
Document Name
Document Number
Testing of Auto verification of Results
Request Notification of LIS Changes Process
Implementation of Changes to Soft Applications
Approval Procedure for Changes to Soft
Evaluation of Change for LIS Request
QIMMI03005
QIMM103000
QIMMI03003
QIMMI03002
QIMMI03001
Revision History
This information is required for annual review.
Date
June 11, 2010
Version
#*
Review, Revised
by, position
QIMMI03
004.07
Dr. T. Mazzulli,
E. Cudek
(Sr.LISO),
J.Jamieson (Sr.
LISO)
Change(s) made
Created Document
T. Mazzulli, MD FRCPC
_________________________________
Signature
Date
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:\533568930.doc
Department of Microbiology
Quality Manual
Section: Request and Notification of LIS Changes
Policy QIMMI03004.09
Page 3 of 3
Subject Title: Auto-verification of Results in
Soft
Record of Edited Revisions
Manual Section Name: Auto-verification of Results in Soft
Page Number / Item
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Annual Review
Date of Revision
May 26, 2004
May 26, 2005
July 12, 2006
August 9, 2007
October 30, 2008
October 30, 2009
May 31, 2011
May 31, 2012
May 31, 2013
Signature of
Approval
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
Dr. T. Mazzulli
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:\533568930.doc