Department of Microbiology Quality Manual / Policy QITMI00000.11 / Page 1 of 4
Section: Quality Manual / Subject Title: Introduction
  1. Overview of the facility and Quality Management System (QMS) manual

The Shared Microbiology Department firmly believes that quality is the basis of healthcare excellence. It is the platform that combines all of the elements of structure, process and outcome. The department has prepared a quality manual that describes and outlines all of the quality processes and procedures designed to meet our quality standards. The quality system ensures that this laboratory has processes that are efficient, effective and meet regulatory requirements.

The Shared Service Department of Microbiology is a partnership of the Mount Sinai Hospital (MSH) and University Health Network .The department provides services to our four home hospitals and many other hospitals and organizations through a fee for service arrangement. This arrangement may be a full service contract or a one-off specimen. Among the institutions served by the Shared Service are Baycrest Center for Geriatric Care, Toronto Rehabilitation Institute, Bridgepoint Hospital, Centre for Addiction and Mental Health, Toronto Grace Health Centre, Ontario Government and many organ donor programs.

The department is under the leadership of Dr. Tony Mazzulli, who has put together a team of professionals devoted to providing the best quality service possible. In addition to Dr. Mazzulli, there are two other Medical Microbiologists directly involved in the operations of the department.

The day to day functions of the department are directed by the Administrative Director, Katherine Wong and the Supervisor Pauline Lo.

All of the above are supported by a caring team of technologists, technicians, Laboratory Information System support personnel and clerical assistants.

  1. The overall scope and use of the QMS manual

This manual has been written in accordance with the CLSI guideline GP26-A3 & HS01-A2 Quality System Model for Healthcare, ISO 10013/ISO 15189 and the OLA/QMP-LS guidelines. The manual establishes policies on a core set of twelve Quality System Essentials (QSEs). The overall scope and use of the manual is as follows:

  1. The policies set out in this manual are mandatory for all staff members. The QSEs are explained to and made easily available to the staff.
  2. The QMS manual policies are linked and aligned with the policies and processes of our client hospitals.
  3. The document serves as an introduction of the Shared Service’s quality system to our clients, regulatory and professional bodies.
  4. This manual has been prepared with input from all staff. The Quality Team and Dr. Mazzulli are responsible for all updates and its contents.
  5. In order to reflect the current best practices and continuous improvement, changes or additions to the manual are documented on the revision history table for each QSE.
  6. The document will be reviewed within one year from date of issue.
  7. This manual is a controlled document and unauthorized alterations and copies must not be made.
  1. QMS Manual Preparation, review and approval
  • Prepared and reviewed by the Quality Team, Management Team and laboratory staff.
  • Reviewed by the Quality Team
  • Reviewed and authorized by Dr. Tony Mazzulli

The QMS Manual will be reviewed annually or if there is a change in practice that affects an existing QSE.

  1. Quality Management contact personnel

Dr. Tony Mazzulli - Tel. 416-586-4695

Ms. Katherine Wong - Tel. 416-586-8538

Mrs. Pauline Lo – Tel. 416-586-3147

Ms. Suzie Ho, Quality Coordinator – Tel. 416-586-4800 ext. 7637

The mailing address for all of the above is:

Department of Microbiology

Room 1488, Mount SinaiHospital

Toronto, Ontario, Canada

M5G 1X5

5. Mission Statement

The department is committed to providing quality microbiological services to all of its constituents and customers.

6. Objectives

The department will:

  • provide consultative services in Clinical Microbiology, Infectious Diseases and Infection Control
  • provide a venue for the training of Laboratory Technologists, Technicians Medical Microbiology and Infectious Disease residents, and other health care professionals as required
  • engage in relevant clinical research and methods development
  • employ a quality assurance program to ensure the proper handling, processing and reporting of patient results
  • ensure that all specimens processed by the department have clinical utility and that the reports are meaningful to our customers
  • foster an environment that will encourage the staff to take part in educational opportunities and to participate in research projects
  • ensure that the working environment and laboratory equipment is constantly monitored to ensure the safety of the employees and visitors
  1. Quality Policy

The management of the department is committed to continuous improvement in order to provide our employees with the tools and resources necessary to deliver quality microbiological services that meet the expectations of our patients and clients.

Record of Edited Revisions

Manual Section Name:

Page Number / Item / Date of Revision / Signature of Approval
Annual Review / October 31, 2003 / Dr. T. Mazzulli
Annual Review / March 5, 2005 / Dr. T. Mazzulli
Annual Review / July 23, 2006 / Dr. T. Mazzulli
Annual Review / May 2, 2007 / Dr. T. Mazzulli
Annual Review, personnel edited / June 16, 2008 / Dr. T. Mazzulli
Annual Review / June 04, 2009 / Dr. T. Mazzulli
Updated TML/MSH to UHN/MSH / June 04, 2009 / Dr. T. Mazzulli
Annual Review / June 04, 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
Annual Review / May 7, 2014 / Dr. T. Mazzulli

Record of Edited Revisions.doc

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

T:\Microbiology\New Manual\Live Manual\Quality Manual\Quality Manual Introduction QITMI00000.doc