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QUALITY MANUAL
Program Co-chairs
Dr. Bernard Fernandes, MD, FRCPC
Joanne Bishop MLT, B. A.
Rita Kandel, MD, FRCPC
Pathologist-in-Chief and Medical Director
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QUALITY MANUAL
TABLE OF CONTENTS
Introduction:
a. Overview of the facility, and quality manual
b. History
c. The overall scope and use of the quality manual
d. Quality manual preparation, review and approval
e. Information about facility
Page 4
Organization:
a. The scope of services / tests offered
b. Vision, Mission Statement, Values
c. Quality Statement
d. Quality Objectives
e. Regulatory, Accreditation and External Quality Assessment Programs
f. Organizational Charts & Floor Plans
g. Overall Operational Processes
Page 6
Personnel Policy:
a. Responsibility
b. Components
Page 10
Equipment Policy:
a. Purpose
b. Responsibility
c. Processes
d. Instrument Selection
e. Performance Characteristics
f. Identification
g. Installation
h. Validation and Verification
i. Calibration and Maintenance
Page 11
Purchasing and Inventory:
a. Purpose
b. Process
c. Records
Page 13
Process Control:
a. Purpose
b. Responsibility
c. Method Implementation
d. Quality Control
e. Changing an Established Process
Page 13
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f. Examples of Supporting Documentation
g. Records
Information Management: Document & Records Control:
a. Scope
b. Documents and Records
c. Laboratory Information Systems
d. Processes
Page 15
Incident Management:
a. Definition and Types of Incidents
b. Patient Safety Goals
c. Processes
Page 18
Facilities & Safety:
a. Scope
b. Responsibilities
Page 20
Process Improvement and Assessments:
a. Purpose
b. Opportunities for Improvement
c. Management Review
d. Preventive and Corrective Actions
e. Responsibilities
Page 21
Service & Satisfaction:
a. Responsibility
Page 23
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INTRODUCTION
Overview of the facility & quality manual
The Pathology and Laboratory Medicine (PLM) department of Mount Sinai Hospital (MSH) believe that
quality is the hallmark of our healthcare excellence. It is the platform of all functional elements of
structure, process and outcome. As such, the department has prepared a quality manual that describes
the quality management system and refers reader(s) to the appropriate processes and procedures. The
system ensures that the laboratory services are efficient, effective and meet regulatory requirements.
The department continually strives for excellence while meeting and exceeding the needs of our
patients and healthcare personnel.
History
Mount Sinai Hospital is an internationally recognized academic ~500 bed healthcare centre affiliated
with the University of Toronto. Reflecting its academic strengths and Centres of Excellence, the
hospital’s priority programs include, Surgical Oncology, Musculoskeletal Disease, Inflammatory Bowel
Disease, Urgent and Critical Care, and Women’s and Infants, as well as the Samuel Lunenfeld Research
Institute.
The year of 2008 marked the 85th anniversary of Mount Sinai Hospital, Toronto and the 60 th anniversary
of its laboratories. The laboratory services began in a second floor broom closet in the original Mount
Sinai Hospital, 100 Yorkville Avenue, staffed by a part-time pathologist, Dr. Harold Pritzker, and a parttime secretary/laboratory technician/ECG technician. Today, with more than 35 medical/scientific
staff, ~300 support staff and more than 40 graduate students and post-doctoral fellows, the
department of Pathology and Laboratory Medicine at Mount Sinai Hospital enjoy a superb international
reputation for service quality, safety and innovation.
From the laboratory bench to the patient bedside, the hospital’s integrated activities focus on
delivering quality, compassionate patient care and contribute to the development of innovative
approaches to ensure accurate and timely diagnosis, delivery of effective health care and disease
prevention through research and teaching.
The overall scope and use of the quality manual
The manual, in accordance with the CLSI/NCCLS guideline GP26-A4, ISO 15189 and OLA/QMP-LS
requirements, establishes policies on a core set of twelve quality system essentials (QSEs). These QSEs
are integrated in overall patient care laboratory processes that reflect our values and good laboratory
practice culture in the healthcare services.
The principles of `Documentation Pyramid’ are used to set and to maintain the intent of PLM/MSH
direction. The overall scope and use of the QMS manual is as follows:
a. The policies set out in this manual are mandatory for all staff members, encompassing all
laboratory processes and management activities. The document is explained, and made easily
available, to all staff.
b. The QMS manual policies are linked and aligned with overall hospital policies and processes.
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c. Other procedures not covered by this manual are contained in the documents issued by PLM
and Mount Sinai Hospital.
d. The document serves as an introduction of the PLM quality system to our clients (both internal
& external), regulatory and professional bodies.
e. The initial adoption of the manual, as well subsequent reviews and changes, is authorized by
the Medical Director responsible for the departments.
f. The manual is prepared with input from medical section heads, members of quality committee
(QMS), administrative director, and others as appropriate.
g. The Manager, Quality Systems has the exclusive responsibility for the manual, its contents and
changes.
h. The document will be reviewed regularly to ensure that it continues to be relevant to reflect
our current practices and conforms to the appropriate current industry standards.
i. The manual is a controlled document and unauthorized alterations and copies must not be
made. (Any document appearing in paper form - unauthorized/photocopy is not controlled and
should be checked against the server e-file version in PARADIGM prior to use)
QMS Manual Preparation, Review and Approval
The quality manual is prepared and reviewed by the quality committee, and management staff.
Reviewed, authorized and approved by Medical Director or designate.
Information about facility
Mailing Address of PLM:
Pathology and Laboratory Medicine (Suite 6-500)
Mount Sinai Hospital
600 University Avenue, Toronto, Ontario, Canada M5G 1X5
Quality Management contact personnel:
Position
Name
Medical Director
Vice President
Administrative Director, PLM
Quality Program Director, PLM
Manager, Quality Systems
Dr. Rita Kandel
Ms. Debbie Fischer
Norma Layno
Dr. Bernard Fernandes
Joanne Bishop
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ORGANIZATION
It is the hospital policy to incorporate quality into its organization through active participation of the
senior management, department heads, administrative directors, medical doctors,
biochemists/scientists, managers and technical supervisors from all sections in establishing and
maintaining a quality & safety culture. Management will take a leadership role in developing policies
for each of the quality essentials, ensuring that adequate processes are in place for effective
implementation and monitoring the effectiveness of the quality system through internal audits and
annual management review of the quality system.
The scope of services/tests offered
The department of Pathology & Laboratory Medicine, located mainly on the 6th floor has undergone
considerable changes and re-configuration in recent years to become more service-oriented with
special emphasis on quality and rapid turn-around time. The PLM department have at present,
approximately 300 medical and scientific, technical, administrative, clerical and systems support staff
with a network of sections and units as described below. All services use the same laboratory
information system (LIS - SCC) with appropriate support arrangements.
The principal functions of the Department of Pathology and Laboratory Medicine is as follows:
a. To provide clinically relevant (to meet patient needs and needs of clinical personnel
responsible for patient care), cost effective and leading edge clinical laboratory services of the
highest quality in
 Anatomical pathology (Surgical pathology, Immunohistochemistry, Electron Microscopy,
Autopsy, Morphometry, Metabolic bone, Placenta evaluation)
 Cytopathology
 Division of Diagnostic Medical Genetics Program: Molecular Genetics, Cytogenetics, In
Situ Hybridization
 Biochemical Genetics
 Biochemistry (General chemistry, Special chemistry, Urinalysis, Toxicology)
 Hematopathology (General hematology, Coagulation, Hemoglobin studies, Bone marrow
aspirates)
 Transfusion Medicine
 Point-of-Care Testing
 Flow Cytometry
 Diagnostic Immunology
 Prenatal: Maternal serum screening
 Phlebotomy
 Andrology: Semen Analysis / Body fluid analysis
These services are provided to Mount Sinai Hospital in-/out-patients and other external
healthcare clients.
b. To provide timely and value-added professional consultation to Mount Sinai Hospital clinicians
and professionals from other institutions.
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c. To promote enhanced patient care and reduced length of stay through appropriate laboratory
utilization and continuous quality improvement.
d. To provide medical and scientific education for University of Toronto postgraduate and
graduate students, undergraduate medical and dental students, residents, fellows, elective and
selective students and technical education for community college medical laboratory
technology students.
Numerous staff members of Pathology and Laboratory Medicine collaborate with the Samuel Lunenfeld
Research Institute of Mount Sinai Hospital to develop and participate in research projects in
regenerative medicine, musculo-skeletal diseases, endocrinology and molecular pre-disposition to
breast and gastro-intestinal cancers and perinatal and placental pathology. The departments have
access to the facilities of the Samuel Lunenfeld Research Institute which is located on the 8th, 9th and
10th floors of the hospital and at 60 Orde Street.
Vision, mission statement, values:
Mount Sinai Hospital: `Our Vision, Our Mission, Our Values
http://info2/policies/generalmanual/organization/ia5/view
PLM [Paralink:<PLM Goals and Objectives>]
Strategic Initiatives are included as part of the Management Meeting Minutes, Quality and Operations
Council Meeting minutes.
Quality Statement
In keeping with the vision and mission statement of our hospital, the Department of Pathology and
Laboratory Medicine is committed to providing high quality professional diagnostic, research and teaching
services using the philosophy and principles of Total Quality Management (TQM) / Continuous Quality
Improvement (CQI). To accomplish this, we:
a. Seek the views of our clients and peers within the hospital and the community.
b. Ensure that we always provide a service which meets their ever-changing needs.
c. Meet all applicable regulatory, statutory and contractual agreements, and relevant
national/international professional practice standards.
d. Evaluate/assess the work processes for risks and improve all activities, optimizing the overall
operation of the department.
e. Create an environment (Healthy Workplace) in which all staff derive satisfaction from their work
and are proud to be associated with the department by:
 Removing barriers (undue pressures, conflicts) between our staff in all areas and at all
management levels in order to promote mutual trust, confidence, respect, cooperation and
to build team-work.
 Ensuring that they know how to perform their tasks properly and in a manner which best
fulfills the aims of the department/hospital.
 Ensuring that all policies/procedures are accessible and communicated to all personnel. (It is
required that all staff familiarize themselves with the PLM QMS and apply it at all times)
 Encouraging programs of education, research and development, and self-improvement to
help each staff member achieve his/her best with appropriate allocation of resources for the
QMS and service operations.
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Quality Objectives
Quality
a.
b.
c.
d.
e.
f.
Objectives for Pathology and Laboratory Medicine include:
Support diagnosis, prevention and management of disease states.
Generate information having clinical utility and optimal impact on health outcomes.
Meet pre-determined targets for accuracy, reproducibility and traceability.
Strive to minimize error.
Are timely, safe, efficient, cost-effective
Focus on client satisfaction and continual improvement
Regulatory, Accreditation & External Quality Assessment Programs
To assure students, clients and healthcare personnel, that the departments have established an
excellent record of strict compliance with regulatory and professional practice standards that is
maintained on an on-going basis:
Regulatory and Accreditation Certificates
a. Ontario Laboratory Accreditation Program (OLA) based on ISO 15189, Quality Management
Program – Laboratory Services (QMP-LS), Ontario Medical Association (OMA). Successfully
completed November 2008. Certification valid until April 2013. [Paralink:<QMPLSAccreditationCertificate exp 2013>]
b. Laboratory Licence # 4194, Ministry of Health and Long-Term Care, Ontario. Expiry date April
01, 2013. [Paralink:<MSH Laboratory Licence Expires April 2013>]
c. Laboratory Accreditation Program (LAP), College Of American Pathologists (CAP), On-site
inspection June 15, 2011. Fully accredited until June 27, 2013.[Paralink:]
d. Acute Care Standard-8 (Laboratory), Canadian Councils For Health Services Accreditation
(CCHSA), Hospital Acute care Standards. Accreditation Canada – New ROPS.
e. American Association Of Tissue Banks (AATB).
f. Health Canada, Tissue Program.
g. Food and Drug Administration, Department of Health and Human Services, U.S. Good
Laboratory Practice (cGLP) standards for clinical and pre-clinical research laboratory services
based on U.S. Federal Register, 21 CFR Part 58.
In keeping with Ontario Ministry of Health and Long Term Care, and CAP requirements, PLM commits to
the immediate notification of both organizations in the following circumstances:
1. investigation of to laboratory by a government entity
2. adverse media attention related to laboratory performance
3. change in laboratory test menu (must occur prior to starting patient testing)
4. change in location, ownership or directorship of the laboratory
Additional terms of accreditation by the CAP are listed in the laboratory's official notification of
accreditation and must be adhered to. They include notification of CAP regarding the following:
5. The laboratory being subject to a validation inspection
6. Discovery of actions by laboratory personnel that violate national, state or local regulations
In addition, the laboratory must:
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7. Provide an inspection team comparable in size and scope if requested by CAP
8. Cooperate with CAP when the laboratory is subject to a CAP investigation or inspection
9. Adhere to the Terms of Use for the CAP Certification Mark of accreditation
Teaching Site Accreditations
a. Certificate Of accreditation in Medical Laboratory Technology Training. The Michener Institute
for Applied Health Sciences and Partner Sites
b. Certificate Of accreditation in Medical Laboratory Technology Training. St. Lawrence College
and Partner Sites.
c. Certificate Of accreditation in Medical Laboratory Technology Training. University of Ontario
Institute of Technology and Partner Sites.
d. Canadian College of Medical Genetics Accreditation
e. CCMG Committee - Recognized training site in Cytogenetics.
f. Michener Diagnostic Cytology Program Accreditation.
External Quality Assessment Programs: Highlights
a. Quality Management Program – Laboratory Services (QMP-LS), OMA, Toronto
 Mandatory External Quality Assessment Program (EQA). For complete Testing Program, visit
QMP-LS website. http://www.qmpls.org
b. College Of American Pathologists (CAP). 325 Waukegan Road, Northfield, IL 60093-2750
1. Inter-laboratory Proficiency Testing Surveys, Q-probes & Education Case Studies including:
Biochemistry, Hematopathology, Transfusion Medicine, Immunopathology, Flow Cytometry,
Point of Care Testing, Anatomic Pathology - Performance Improvement Program,
Immunohistochemistry, Autopsy Cytopathology - Cervicovaginal & Non-Gynae,
Cytogenetics, Molecular Pathology, Andrology, Maternal Serum Screening, Instrumentation,
Linearity surveys, etc., as well as Audio conferences, Laboratory Inspection Checklists
c. The European Molecular Genetics Quality Network (EMQN), National Genetics Reference
Laboratory, c/o Regional Molecular Genetics Laboratory, St. Mary's Hospital, Hathersage Road,
Manchester M13 0JH, UK.
 EQA registrations: Hereditary non-polyposis colon cancer (HNPCC); Y-Chromosome
microdeletion
d. Vitamin D External Quality Assessment Scheme (DEQAS), London, UK.
e. Canadian Immunohistochemistry Quality Control – CIQC, Path & Lab Medicine, Royal University
Hospital, Saskatoon, SK. www.ciqc.ca
f. UK NEQAS (ICC & FISH) External Quality Assessment Scheme-2007: Module 1: Breast Pathology
HER2 FISH (3 runs/year); Module 2: Breast Pathology HER2 IHC (4 runs/year)
A full listing and record locations are located in Paradigm [Paralink:<Audit of External Proficiency
Testing Programs>]
Organizational Charts & Floor Plan
Organizational charts are available and provide an insight into the internal structure of the department
as well as how the department relates to the organization as a whole.[Paralink:<Pathology &Lab
Medicine Org Chart>]
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Floor Plans are available in the Organization folder of Paradigm.
Overall Operational Process
Each laboratory service has established the operational process with a flow chart(s) for each working
area with an annual review and revision.
Each laboratory section maintains communication structure based on day-to-day operational needs
through local staff meetings and in-service educational sessions. In keeping with the patient safety
plan, all hand-off communications/responsibilities (e.g. pending specimens, tests and patient care
issues, significant medical information) are managed effectively when there is a staff change in work
shift or a case transferred from one pathologist to another with an opportunity for asking and
responding to questions.
PERSONNEL
Personnel policies are under the control of the Human Resources department of the hospital. PLM has
established and maintained a planned and systematic initial orientation/training and competency
assessment process to verify and document that personnel have, and can demonstrate, the necessary
knowledge, skills, judgment and professional conduct to perform their respective duties.
The policy sets direction for appropriate selection of new staff as per service (tasks) requirements,
orientation/training, assessment of competence after initial training and periodically thereafter, and
provides opportunities for professional growth of laboratory personnel.
Responsibility
In collaboration with the hospital Human Resources department, the laboratory’s management recruits,
hires, trains, manages and assesses its personnel. Individual laboratory supervisors and medical section
heads participate and provide input where appropriate.
Laboratory personnel are responsible for maintaining individual competence, documenting required
continuing training and maintaining their licence to practice (regulatory college), as required.
Components
Job qualifications
PLM sets qualifications for the education, experience and skills for each job
title in the laboratory in accordance with regulatory and accreditation
requirements.
Job Descriptions
PLM establishes and maintains the job descriptions for each job title in the
laboratory, that include required qualifications and job duties/tasks. Job
Descriptions are found in Paradigm.
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Orientation
The hospital provides a general orientation program for new employees. PLM
has department-specific orientation programs that is linked and aligned with
the hospital program. Training/re-training because of changes in the work
processes (and extended leave) is also provided, as applicable.
Competence
A process for competency assessment [Paralink:<Competency Assessment
Policy>]after initial training and periodically thereafter is established.
Employees are encouraged to seek opportunities to improve assigned tasks
where appropriate. Employees must successfully demonstrate competence in
their assigned role/tasks. Failure to demonstrate competence is managed on
an individual basis with corporate support.
Continuing Education
PLM supports and provides opportunities for continuous learning and encourage
employees to seek on their own as well. This fosters employee growth, meets
professional practice requirements and improves customer service. Professional
development is included in performance assessment in which employee input is
sought and appropriate direction and support is given.
The hospital has taken the initiative to provide funding for part-time degree
programs and advanced studies.
Personnel Policies
In keeping with the hospital HR policies, PLM has developed and established
department/discipline specific personnel policies, e.g. hiring, performance
appraisal, grievance, end of employment, vacation time, dress code, etc.
Hospital policies are found on the Mt. Sinai Intranet; PLM policies are found in
Paradigm.
Performance Reviews
Technical staff performance reviews are conducted via an automated system.
The Halogen system sends reminders to set goals, review goals, review
performance and complete an annual interview. The program opens annually
and target dates for completion are pre-set. Since there is no access to files
once the completion date is past any unfinished performance reviews may be
printed and completed manually. However, such completion will not be
reflected in the recorded completion statistics released by Human Resources.
PLM’s completion rate should exceed 85% each year.
EQUIPMENT
PLM has established and maintained a policy on equipment and instruments to ensure continued
support & service with a commitment to using equipment best suited for the needs of our patient
population. This is in alignment with the hospital’s purchasing policies available through the intranet.
Purpose
The policy provides direction to ensure that all equipment and instruments, whether leased or
purchased, used in each laboratory section, are properly selected for the intended use, installed,
calibrated, verified, operated and maintained according to established procedures and manufacturer’s
instructions. Energy use and other potential environmental impacts including future disposal are also
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considered in the selection process. Any additional regulations/accreditation requirements for specific
healthcare services are also followed. The process “Equipment Purchase Process[Paralink:<Equipment
Purchase Process>]” is available, however may be modified based on direction of the finance
department and the purchasing agent.
Upon acquisition, each equipment or instrument is uniquely identified. Installation by the manufacturer
must be certified and documented for its safe working condition and application. The laboratory
validates and verifies the instrument functions according to established procedures, including, if
applicable, LIS interfacing before use in a clinical service environment.
Trained individuals (either laboratory personnel and/or manufacturer’s service engineers) will carry out
all routine calibration, maintenance and preventive service of equipment according to manufacturer’s
instructions including computer hardware/software updates. All of the above activities will be
documented and reviewed by supervisory personnel. In addition, all troubleshooting, repairs and post
repair activities (verification of suitability for return to service) are documented and records kept until
two years after the instrument or equipment is decommissioned. Criteria and mechanism for retiring
outmoded or obsolete equipment are defined.
It must be noted that when information reasonably suggests that a laboratory instrument, reagent or
other device (such as an accessory device used for phlebotomy or specimen collection) has or may have
caused or contributed to a patient death or serious patient injury, it must be reported to Health
Canada (Health Products and Food Branch). If the event is death, the report is made both to Health
Canada and the device manufacturer. If the event is serious patient injury, the report may be made to
the manufacturer only, unless the manufacturer is unknown, in which case the report must be
submitted to Health Canada. Reports must be submitted on: Medical Devices Problem Report Form Health Products and Food Branch Inspector.
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/md_prob_reprap_incident_im-eng.php
This is done within 10 days of the incident, i.e., from the time medical personnel become aware of the
event.
Responsibility
Laboratory directors and Medical/Scientific section heads
Management
Supervisory/Charge medical laboratory technologist
Medical laboratory technologists
Manufacturer – where appropriate
Installation
The manufacturer’s specifications pertaining to space, ventilation, humidity, temperature, water
quality type, potential hazards and other requirements are to be verified on installation by the
manufacturer’s representative. Critical instruments must be protected from power interruptions. A
document of certification is issued to the laboratory attesting to the fact that proper function of the
instrument was verified and that it is ready for use in the live environment.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
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Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
Validation and Verification
Procedures for validation and verification of processes are to ensure that the required performance and
function of the instrument are met before implementation which includes the review and approval
process by the scientific staff.
Calibration and Maintenance
Calibration procedures and frequency of calibration are performed according to manufacturer’s
instructions and recommendations. In addition, PLM uses CAP calibration verifiers to ensure that
instrument performance is comparable with other users.
A service contract for preventive maintenance and service calls are set up for each instrument in
addition to maintenance procedures performed by trained laboratory personnel. All records are kept in
the Maintenance Log book or in the common instrument records maintained by the assigned medical
secretary.
PURCHASING AND INVENTORY
PLM mechanisms for the purchase of desired quality laboratory consumables, reagents and inventory
management are aligned with the hospital purchasing policy/process. PLM establishes selection of
qualifying suppliers, approved vendor listing, contract review and a system for verifying incoming
critical materials based on industry standards. It is an established practice to use all consumable goods
as per manufacturer’s specifications. To ensure continual (24/7) laboratory service, a backup system is
defined locally for all methodologies that are in current use. The PLM department has established good
relations with providers of materials and services.
Purpose
All laboratory consumables/goods including reagents and quality control material used in the
performance of patient testing are handled in a consistent manner to ensure that patient testing is not
compromised. Critical supplies/reagents (e.g., time- and temperature-dependent) are handled as per
requirements.
Process




Purchasing & inventory process flowcharts
MSH receiving process
Purchasing guidelines, as appropriate
Laboratory specific procedures: storage, monitoring of inventory, standing orders, QC, etc.
Records



Purchase contracts, agreements
Inspection and testing of received materials
Inventory logs, critical material checks
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
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Quality Management System
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Approved By:
Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed

Vendor evaluation documentation, as applicable
PROCESS CONTROL
PLM department has established and maintain the policy on process control.
Purpose
PLM policy is to identify the operational processes, define them through flowcharting, and validate
them to ensure that the processes work as expected to meet regulatory/accreditation, customer
requirements and organizational needs. The quality manual, hospital general manual, laboratory
procedure manuals and safety manual will establish process requirements and ensure standardization
across PLM. This also applies to service contracts with external facilities (e.g., referral laboratories)
that impact PLM services.
Responsibility
The management staff develop and maintain the processes for the quality system essentials (QSEs).
The individual section staff (medical/scientific staff, charge technologists, supervisors and working
staff) will analyze, develop and maintain their individual laboratory section work processes. These
process flowcharts will be supported by appropriate laboratory procedures.
Method Implementation:
a. Identification and procurement of the necessary resources.
b. (Analysis and design of work processes to ensure needs & expectations of clinical
programs/customers).
c. Documentation of the process and supporting procedures.
d. Validation that the process works as intended, and internal and external quality control as per
standard practice.
e. Control of changes to established processes with documentation.
f. Use of statistical tools to monitor process performance using established quality indicators.
g. Performance of corrective actions with root cause analysis, as appropriate.
Medical significance of non-conforming laboratory analyses is always considered. After thorough review
and where appropriate, the requesting physicians are notified.
The departments have established appropriate service contracts as per regulatory requirements with
external facilities to ensure that on-going clinical service needs are met. Appropriate process
documentation is defined for the selection, use and monitoring of referral laboratories. This includes
professional consultants for their clinical services.
Quality Control
PLM establishes and maintains a quality control program to verify test method performance. The
quality control included as part of the laboratory procedure manuals will be used to detect
errors/trends, and where needed, process controls will also be included to prevent errors.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
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Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
Changing an established process
PLM uses project management tools to design, develop, and review changes to established quality and
operations processes so that both the QSEs and path of workflow are routinely considered (please refer
to QSE: Process Improvement)
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
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Quality Management System
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Approved By:
Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
Examples of Supporting Documents
a. Process Validation [Paralink:<Process Validation>]
b. Individual laboratory section work process flowcharts, RRL QA checklist, Verification of
Clerical/Analytical Error [Paralink:<Verification of Clerical & Analytical Functions>]
c. Validation that customer needs & expectations are met by the services offered
d. Validation of performance specifications for equipment & supplies
e. Quality Control Program: Internal & External programs, review, QC Plan
f. Point of care testing policy/process/procedures
g. How to Write Procedures - SOP How To Write SOP[Paralink:<How to Write an SOP>], Technical
SOP Template[Paralink:<Technical SOP Template>], Non-Technical SOP template [Paralink:<Non
Technical SOP TEMPLATE>]
h. Specimen rejection: Unacceptable Specimens [Paralink:<Unacceptable Specimens>]
i. Process of providing consistent services: Reporting Of[Paralink:<Reporting Of Results Policy>],
Critical Result Reporting Process[Paralink:<Critical Result Reporting Process>], Critical Result
Procedure[Paralink:<Critical Result Reporting Policy>]
j. Process for changing an established procedure: CQI Plan form
k. Appropriate statistical tools: Quality Improvement Activities
l. Process to ensure that regulatory and/or industry standards are met
m. Process to ensure an adequate and safe work environment
n. Selection and Monitoring of Referral laboratory and consultant: Referral Laboratory
[Paralink:<Selection and Monitoring of Referral Laboratories Process>][Paralink:<Selection and
Monitoring of Referral Laboratories and Consultants Procedure>]
Records
a.
b.
c.
d.
e.
New method evaluation & validation data
Internal & external QC data, appropriate review, corrective actions – if applicable
Referral Lab records
Annual review of processes & laboratory procedures
Safety audit reports
INFORMATION MANAGEMENT: DOCUMENT AND RECORDS CONTROL
Purpose
The intent of this policy is to provide direction for effectively managing and maintaining PLM’s
documents and records to ensure that only current approved documents are available for use during
the performance of all laboratory activities.
Scope
This policy applies to all staff within the PLM department and applies to all documents that have been
developed by PLM, authorized by the Medical Director/designee, given an effective date for
distribution and use.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
PATHOLOGY & LABORATORY MEDICINE
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Name:
Version No:
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Rita Kandel, Dr
Uncontrolled When Printed
Responsibility
Quality Manager

to establish and maintain the document control system
Managers/Designate







to create, review and approve all necessary documents and forms
to follow approved processes for the receipt of new or replacement versions of documents
to place hard copy documents in designated controlled locations
to follow approved processes for the development, archiving and destruction of documents
or records
to ensure obsolete documents or records are promptly removed
to ensure all staff have access to documents they need to perform their work
to manage the storage and retrieval of all required documents and records

to follow document controlled processes and procedures
Staff
Policy Statement
The Pathology and Laboratory Medicine department is committed to developing, maintaining and
archiving controlled documents and records to support organizational objectives and facilitate the
management of our operations and quality management system.
This quality practice provides direction for staff to use only controlled documents in their work and to
generate and handle records in a standardized and consistent manner. It is to ensure that only those
policies and procedures that are current, standardized, and authorized are used, and that outdated
documents are appropriately identified and archived.
Documents and Records
Documents and records are used for quality, financial, historical and legal purposes. They help to
facilitate our service to meet high standards of patient care, regulatory and accreditation requirements
and quality audits.
Document management software (PARADIGM II) is used in PLM for document control. All of the current
documents and records are stored using this software platform for easy accessibility as well for timely
review & revision. This quality practice assures that our stakeholders and staff use the most current
documents and /or records for use in their specific activities. The document management software
ensures consistency across departments in keeping with current document control standards.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
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Quality Management System
Prepared / Reviewed By:
Approved By:
Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
Document Development, Approval and Revision
Documents are developed in Paradigm II using one of the standard templates, with the approved font
Trebuchet MS size 10 or 11.
Processes and procedures are validated prior to approval and implementation. In order to validate a
procedure the author will distribute the procedure to individuals working in the intended environment
for use. The individuals will review the process or procedure in a step wise fashion and return
corrections back to the author. In cases where a functional process requires changes rather than the
written process, the manager or designate will ensure all staff receives appropriate communication
and/or training prior to implementation. Once a final draft has been validated and accepted by the
reviewer and author, both must sign the final draft.
Documents are approved electronically through completion of action items in Paradigm
[Paralink:<Document Authorization and Related Action Item Procedure>]
The revision process ensures that only authorized changes are made to approved documents, that all
changes are reviewed and approved before use, and that all copies of the document in use reflect the
change. Routine changes to documents are made as they occur and approved prior to implementation.
Documents are revised as needed and changes are identified through use of the document. All changes
to documents are approved by the approvers and re-issued as a new version.
Documents are reviewed on an annual basis to ensure that they are still correct, complete and current.
This review is scheduled and tracked through Paradigm.
All process and procedures for the use of the document control system are available in Paradigm in the
folder “Document Control”
Laboratory Information Systems
A Laboratory Information System (LIS) is available for the receipt of orders, entry and transmission of
results. Policies, processes and procedures are in place. The system allows review of entered data
before accepting results.
There are policies, processes and procedures for modifications to a filed result. A LIS procedure manual
(electronic version and a hardcopy as backup) written in plain language and understandable to the
users is available.
The LIS officer is responsible for system maintenance, operation and support. The LIS has security
levels that prevent unauthorized modification to the systems maintenance. Appropriate documentation
is maintained of version use with inclusive dates, and validation of upgrades before live
implementation. There is a process in place for computer systems downtime to ensure that continual
operation will be maintained.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
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Quality Management System
Prepared / Reviewed By:
Approved By:
Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
All process and procedures for the use of the LIS are available in Paradigm in the folder “Laboratory
Information System” or the relevant department.
INCIDENT MANAGEMENT (Non-conformities)
PLM is committed to promoting and maintaining a safe environment for patients, visitors and staff. All
incidents are investigated promptly and consistently. The process is non-punitive in nature and the
intent is not to affix blame but to identify system issues, gaps and deficiencies and implement the
necessary improvements. It is recognized that human performance is greatly influenced by
environmental or system factors. Issues related to accountability for deviation from professional
standards may be identified in the review but are not the focus of this policy.
The incident reporting system is an organized process to capture, analyze, and report on untoward
events that do not conform to established policies, processes and procedures.
The system allows for classification of events/incidents and trend analysis for process improvement.
The key elements and processes in place are as follows:
a.
b.
c.
d.
e.
f.
g.
Detection
Documentation
Investigation for root cause (where applicable)
Remedial/Corrective action
Reporting
Follow-up & communication
Statistical analysis for trending, bench marking
The policy is aligned with the hospital’s Safety Reporting program and is applicable to all laboratory
sections and support services.
Types and Definitions of Incidents:
Any incident on an MSH patient that has a direct impact on patient safety OR originates outside of the
laboratory are entered into the Patient Safety database. The incidents in this system are graded as:
a. Type I – Critical; Incident that results in serious undesirable and unexpected outcome involving
actual or potential loss of life, limb or function. The incident could cause embarrassment/risk to
the hospital with potential legal ramifications and/or broad media coverage.
b. Type II – Severe; Incident where there is a potential harm (not immediate) to a patient/visitor.
Actual adverse event with successful intervention and outcome.
c. Type III – Moderate; Incident where there is no harm to patient/visitor. Minor self-limiting adverse
outcome with minor intervention required. X-ray and lab tests (if performed) remain normal or
unchanged.
d. Type IV – Minor; Incident where there is no harm to patient/visitor. No clinical significance or no
known adverse outcome.
e. Near Miss Good Catch; An error was caught and remedied before an incident occurred.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
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Approved By:
Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
Incidents that occur within the laboratory, and involve samples from non-Mt. Sinai patients, are not
entered into the Patient Safety database but instead documented on the PLM incident Investigative
form. This system is entirely paper-based.
The same grading system as described above is used in the PLM incident report form system. Any
occurrence that meets the following criteria should be documented:
a.
b.
c.
d.
e.
Negative impact on patient care
Negative impact on laboratory practice (financial or legal)
Equipment malfunction when adversely affect patient samples
Accident: a major unplanned event that causes harm.
Complaint: Any issue of concern or dissatisfaction raised by a customer/patient/physician. All
complaints are attended and documented.
f. Deviation: Any variation (nonconformity) from approved operating procedures that may or may not
affect the quality of the product or service. This may be planned or unplanned, and result in EQA
survey flags.
g. Error: An incident that represents a deviation from applicable standards or established
specifications that is typically considered within the realm of control of the laboratory, e.g.,
reporting wrong results, specimen mix-up, dilution, privacy breach, reporting errors, misdiagnoses,
lost samples, mislabeled/misidentified samples, improperly collected samples, incomplete/invalid
test runs, ID and reporting errors, etc. (See incident investigative form for an extended list). Can
be grouped into pre-analytical, analytical, and post-analytical.
Patient Safety Goals
In keeping with the laboratory accreditation program, PLM has established four major patient safety
goals:
a. Improve patient and sample identification.
b. Improve verification and communication of life-threatening or life-altering information (e.g.,
critical result reporting).
c. Improve identification, communication and correction of errors.
d. Improve integration and coordination of the laboratory's patient safety role within the health care
provision network (care-givers).
All PLM staff are responsible for properly identifying and reporting/documenting accidents, errors,
nonconformities, and complaints. Any verbal or written complaints from the service users (clients) are
immediately attended to, documented and resolved. Staff are also encouraged to communicate any
concerns or complaints with respect to the quality of patient testing and safety. The incident reporting
process[Paralink:<Incident Report Process>]is aligned with the hospital policy/procedure is available in
Paradigm.
The management report, submitted annually for review by the Medical Director/Designee may include
a summary of the incident statistics.
PLM has the official CAP sign posted prominently regarding the reporting of quality concerns to CAP. It
is internal policy for staff to report quality or safety concerns directly to local laboratory supervisory
personnel and higher management first. However, staff may communicate with the CAP office directly
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
PATHOLOGY & LABORATORY MEDICINE
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Approved By:
Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
in strict confidence only if the quality/safety concerns are not addressed by the PLM management
team. This (concern) activity is recognized as non-punitive by the management of PLM.
Processes
MSH Intranet: Safety Reporting System
MSH Intranet: Occupational Health and Safety
Incident Report Process[Paralink:<Incident Report Process>]
Incident Investigative Form [Paralink:<Incident Investigative Form>]
Incident Reporting[Paralink:<Incident Reporting>]
Investigation of Reported Incidents[Paralink:<Investigation of Reported Incidents>]
FACILITIES AND SAFETY
The PLM department works with supporting departments, e.g., building services, Fire Marshall, within
the hospital that provide advice, direction, and maintenance to ensure a safe, healthy working
environment for all personnel.
The departments promote active participation of all staff including the hospital Joint Health and Safety
Committee representatives. The objective of this program is to prevent and minimize, to the greatest
extent possible, all risks to the safety, health and well-being of all employees, patients and visitors.
This program also ensures compliance with federal/provincial legislation, local municipality by-laws
and related regulations.
Scope
This policy is applicable to all laboratory sections and support services of PLM.
Responsibility
The decentralized safety program is based upon the principle that while administration has the
responsibility to ensure a safe and healthy work environment, each employee shares responsibility and,
a. complies with all safety policies, emergency plans and standard operating procedures as
specified in the Safety Manual.
b. reports to his/her supervisor and safety officer any health & safety concerns.
c. promptly reports work-related accidents, injuries, or illnesses to his/her supervisor.
PLM is responsible for ensuring a working relationship with the engineering department and other
services to:
a. establish processes for routine maintenance, construction and renovation of physical
environment to maximize safety to staff, patients, visitors in accordance with
regulatory/industry standards.
b. support compliance with safe work practices.
The laboratories:
a. maintain a safety committee and a safety manual,
b. have a designated safety officers(s),
c. have representation on the MSH Joint Occupational Health & Safety Committee, and
d. have a union representative
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
PATHOLOGY & LABORATORY MEDICINE
STANDARD OPERATING PROCEDURE MANUAL
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Name:
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Approved By:
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Rita Kandel, Dr
Uncontrolled When Printed
PLM Health & Safety committee is responsible for:
a. recommending and monitoring standards of practice, policies, and procedures
b. periodic audits (intra- and inter-laboratory)
c. documentation and review of safety concerns, accidents, etc.
d. annual review of safety manual
Manager/Supervisor/Charge Technologist:
a. ensures that work activities are conducted safely and according to established standards
b. ensures that all employees under his/her supervision receive proper orientation, training and
instruction in safe work practices and are made aware of hazards associated with their work in
accordance with legislative requirements
c. ensures that personal protective equipment or other safety devices are used as appropriate
d. ensures that all laboratory equipment is maintained and operated in accordance with
manufacturer’s recommendations and instructions
e. promotes employee awareness and understanding of possible workplace hazards
f. promptly reports and documents all work-related injuries and illness
g. maintains a current list of all hazardous materials under control and makes the MSDS readily
available to staff
h. implements and documents appropriate preventive and corrective actions for noted
deficiencies
i. works together with the Safety Officers/committee in their efforts to promote and maintain a
safe and healthy workplace
j. participates in the annual review of the Safety Manual
k. supports employee participation in health and safety training
PLM provides safety training programs for the following:
a. Emergency procedures: Fire safety, Spills, disaster, etc.
b. Biological safety and standard precautions
c. Infection prevention and control
d. Chemical safety (WHMIS)
e. Radiation safety
f. Transportation of Dangerous Goods (TDG)
PROCESS IMPROVEMENT AND ASSESSMENTS
The PLM department recognizes that the need for improvement exists inherently in all processes, and
accordingly uses multiple tools to initiate and monitor process improvements.
Purpose
Direction is provided for achieving continual improvement through the use of established quality
management tools and by identifying new opportunities to improve patient care. Changes to
operational processes resulting from corrective action investigations are documented, implemented
and followed-up for effectiveness under the direction of the laboratory director.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
PATHOLOGY & LABORATORY MEDICINE
STANDARD OPERATING PROCEDURE MANUAL
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Name:
Version No:
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Date:
Status
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Quality Management System
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Approved By:
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Rita Kandel, Dr
Uncontrolled When Printed
Tools to Initiate and Monitor Process Improvements
a. Collection and analysis of data regarding incidents (nonconformities), including trends;
b. Client feedback e.g., physicians, patients, external customers, employees and others
(interviews, complaints, surveys);
c. Performance on external assessments (governmental, accreditation or other);
d. Performance on quality indicators (e.g., patient safety indicators);
e. Performance on internal quality audits;
f. Management review;
g. Benchmarking information;
h. Review of policies and procedures;
i. Strategic planning
j. Reports from other areas in the organization;
k. Any other source that suggests a difference between customer needs and organizational
delivery.
Management Review
A retrospective management review done at appropriate intervals summarizes and evaluates the
status, adequacy, effectiveness and efficiency of the Quality Management System for the purpose of
continual improvement. This formal review and assessment provided to the laboratory director and key
management personnel by the quality staff assists the management in decision making for the
promotion of quality improvements. A management review procedure [Paralink:<Management Review
Procedure>]is available in Paradigm.
Responsibility
Medical Director: Annual review of Quality program; laboratory processes/procedures; Statistics on
quality indicators; patient care outcomes, surveys; performance review (audits)
Medical Section Head: Periodic and annual review of Incident management
indicators/statistics/complaints; discipline specific process review; quality controls (internal &
external); performance review (customer satisfaction surveys); laboratory procedure review
(methodology, clinical relevance); Quality Assurance measures; turn-around times.
Charge Technologist/Supervisor/Manager: Assigned process review; Daily & periodic quality control
review; ongoing competency assessments; Adherence to good laboratory practice; quality assurance
measures; Quality indicators; laboratory procedure review.
Technologists/Technicians: Conformance with established standards of practice; Problem
identification, documentation & reporting; Meeting quality and patient safety goals.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed
PATHOLOGY & LABORATORY MEDICINE
STANDARD OPERATING PROCEDURE MANUAL
Document
Name:
Version No:
Effective
Date:
Status
Page 24 of
24
Quality Manual
1.14
6/4/2013
CURRENT
Document Type & No.
Section/ Subsection:
Document 16574
Quality Management System
Prepared / Reviewed By:
Approved By:
Joanne Bishop
Rita Kandel, Dr
Uncontrolled When Printed
SERVICE AND SATISFACTION
PLM is to be responsive and accountable to the internal and external clients, e.g., patients, physicians,
nurses, allied healthcare professionals, healthcare professionals, other healthcare facilities, and
students to ensure that their service needs are met and to increase satisfaction with the PLM services.
Details are found in the document “Survey Procedure[Paralink:<Survey Procedure>]”.
The staff of PLM are committed to work with stakeholders to ensure and improve where necessary
stakeholder satisfaction with products and services. The front-line measurables of the service are
found in our ability to:
a. Provide prompt availability of consultation on any product or service;
b. Report findings of any examination deemed urgent and appropriately identified by Client as
soon as possible by telephone, fax or other electronic report transmission;
c. Communicate changes to laboratory test methodologies, reference range changes, etc.
d. Further strengthen and enhance current services.
Responsibility
a. Medical director/management to review the data periodically
b. Quality Manager to ensure appropriateness of mechanism and periodic review & follow-up
c. Technical, management and medical staff responsible for the area to assess needs of their
clients and set up appropriate procedures to assess satisfaction.
Any document appearing in paper form is uncontrolled and should be checked against the master electronic current version prior to use.
Only original printed material with the “CONTROLLED” water mark may exist in designated locations. The controlled printed document
should only be used when the electronic version is unavailable. Unauthorized photocopies or alterations of this document are uncontrolled
documents.Uncontrolled When Printed