Department of Microbiology
Quality Manual
Section: Process Control
Prepared by: QA Committee
Issued by: Laboratory Manager
Approved by: Laboratory Director
Form QPCMI12001.09
Page 1 of 3
Subject Title: New
Method/Test/Project/Change
Implementation Checklist
Form
Original Date: July 22, 2003
Revision Date: April 20, 2007
Annual Review Date: May 31, 2013
Purpose:
This checklist provides a guide to identify items to be considered before implementation of any
change or new method, test or new project.
Procedure:
1. New method/project/test has to be previously approved in principle at the Senior Staff
Meeting.
2. Complete this form prior to implementation of a new test/methodology/project/change to
identify action items
3. Present the completed form at the Departmental Operations Meeting.
Name of New Method/Test/Project or Change: _______________________________________
Date: _____________
Approximate volume (if applicable): _______________
Requested by: _________________
Originated from (Service/Client):__________________
Approved by: ______________________ Approved date: ________________________
Project Leader: _____________________
Item
Consultation with stakeholders
Specimen Transportation requirement
Specimen Management requirement
Workflow issues
Space/Bench requirement
Action needed:
Responsible by:
Status
Human Resources requirement:
- hire
- Labour/management negotiation?
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:\533563025.doc
Department of Microbiology
Quality Manual
Section: Process Control
Item
Supply/Equipment requirement
Financial requirement
Billing procedure
LIS requirement:
- Interface to HIS
 Cerner
 Misys
 Meditech Bacrest
 Meditech RVH
- HIS setup
- interface to instrument
- test setup
- report setup
- workload setup
- Softstore setup
Changes to Procedure Manual
Training requirement
Communication about implemented
change:
- with clients
- with other department(s)
- with staff
- with specimen management at:
 UHN
 MSH 6th floor
 CHC
 Ajax/Pickering
 Bridgepoint
- with call centre
- update web site - SOP
- lab dictionary
For new test, send
application/notification to:
 Ontario Laboratory Licence
 QMP-LS Ontario Lab
Accreditation
 College of Pathologists
Form QPCMI12001.09
Page 2 of 3
Subject Title: New
Method/Test/Project/Change
Implementation Checklist
Form
Action needed:
Responsible by:
Status
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:\533563025.doc
Department of Microbiology
Quality Manual
Section: Process Control
Item
Form QPCMI12001.09
Page 3 of 3
Subject Title: New
Method/Test/Project/Change
Implementation Checklist
Form
Action needed:
Responsible by:
Status
Post implementation audit(s)
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:\533563025.doc