IM (PORTANT TEMPLATE Quality Manual

QUALITY MANUAL
LABORATORY SERVICES
FACILITY NAME(S)
Page 1 of 40
QUALITY SYSTEM
TABLE OF CONTENTS
1.0 INTRODUCTION 2
1.1 Scope 2
1.2 Distribution 2
1.3 Revisions 2
2.0 GLOSSARY 3
3.0 GENERAL INFORMATION 3
3.1 Vision 3
3.2 Mission 3
3.3 Organizational Values 3
3.4 Organization Identity 3
4.0 QUALITY SYSTEM 4
4.1 Quality Policy 4
4.2 Quality Objectives 4
4.3 Quality System Essentials 4
4.4 Quality Plan 4
5.0 QUALITY SYSTEM ESSENTIALS 5
5.1 QSE: Organization Policy 5-7
5.2 QSE: Resources Policy 8-10
5.3 QSE: Equipment Policy 11-14
5.4 QSE: Supplier and Customer Issues Policy 15-17
5.5 QSE: Process Control Policy 18-22
5.6 Overall Blood Bank/Transfusion Service Path of Workflow 22
5.7 QSE: Documents and Records Policy 23-26
5.8 QSE: Deviations, Non conformance and
Complications Policy 27-31
5.9 QSE: Assessments Policy 32-34
5.10 QSE: Process Improvement through Corrective
and Preventive Action Policy 35-38
5.11 QSE: Facilities and Safety Policy 39-40
EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

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LABORATORY SERVICES
FACILITY NAME(S)
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1.0 INTRODUCTION:
1.1 SCOPE:
This document describes the overall quality system used by

[facility(ies)/district] and is a mandatory requirement of the system. The
manual defines the quality policy and quality objectives as well as
management’s commitment to quality.
The quality system of the laboratory testing areas listed below is based on the
following guidelines and standards:
LABORATORY DEPARTMENT APPLICABLE STANDARD/GUIDELINES

• CSA Z902-04 Blood and blood
component standard
• Canadian Society for Transfusion
Medicine Standards for Hospital
Transfusion Services Version 1-
Blood Transfusion Service
September 2004
• Canadian Society of Medical
Laboratory Science Standard of
Practice and Code of Professional
Conduct
Water Testing • CANP4D ISO/IEC 17025:1999
General Requirements for the
Competence of Calibration and
Testing Laboratories
Hematology • CSA Z15189-03 Medical
Chemistry Laboratories: Particular
Microbiology Requirements for Quality and
Histotechnology Competence
1.2 DISTRIBUTION:
The quality manual is distributed to [location of all manuals].
1.3 REVISIONS:
The quality manual is reviewed and revisions made on a yearly basis to

ensure they reflect current best practices and continuous improvement.
Documentation of revisions are located [location].

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LABORATORY SERVICES
FACILITY NAME(S)
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2.0 GLOSSARY:
The terms and descriptions used within this quality manual are generally
defined in;
o CSA Z902-04 Blood and blood components standard
o CANP4D ISO/IEC 17025:1999 General Requirements for the
Competence of Calibration and Testing Laboratories
o ISO 15189:2003 Medical Laboratories-Particular Requirements for
Quality and Competence
3.0 GENERAL INFORMATION:
3.1 VISION:
Insert facility vision statement here.
3.2 MISSION:
Insert facility vision statement here.
3.3 ORGANIZATIONAL VALUES:

The following values guide all activities of laboratory services within
[facility(ies)].
List all values of your organization/district.
3.4 ORGANIZATION IDENTITY:

The following facilities are part of District Health Authority [insert district
number] and are active members within the quality system described by this
quality manual
Facility Name Location

Enter facility(ies) name Enter facility(ies) location

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LABORATORY SERVICES
FACILITY NAME(S)
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4.0 QUALITY SYSTEM:
4.1 QUALITY POLICY:

Insert laboratory facility’s quality policy
4.2 QUALITY OBJECTIVES:

Insert laboratory facility’s quality objectives
4.3 QUALITY SYSTEM ESSENTIALS:

Quality System Essentials outline the fundamental elements within the Quality
System and define the policy for each essential. The Quality System
Essentials are:
o Organization
o Resources
o Equipment
o Supplier and Customer Issues
o Process Control
o Documents and Records
o Deviations, Nonconformances, and Complications
o Assessments
o Process Improvement Through Corrective and Preventative Action
o Facilities and Safety
(Refer to Section 5 for more detailed information.)
4.4 QUALITY PLAN

The quality plan is developed by [insert facility’s members responsible for
developing the quality plan] and is in accordance with current CSA Z902-04
Blood and blood components standard, CANP4D ISO/IEC 17025; 1999,
ISO 15189:2003 Medical Laboratories-Particular Requirements for Quality and
Competence and any other accrediting or regulating bodies which the
facility(ies) are maintaining compliance. The quality plan is reviewed yearly
and is accepted by the [insert facility’s requirements].

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LABORATORY SERVICES
FACILITY NAME(S)
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5.0 QUALITY SYSTEM ESSENTIALS:
See following Quality System Essential Charts.
5.1 QSE: Organization Policy
Policy The blood bank/transfusion service has

clearly defined and documented the parties
responsible for the provision of blood, blood
components, and services, and the relationship
of individuals responsible for key quality
functions.
Purpose This policy provides direction for the processes

and procedures to organize, maintain, and
monitor the blood bank/transfusion service
quality system.
Responsibility • The blood bank/transfusion service

executive management has the authority
and is responsible for:
− the blood bank/transfusion service
operations,
− compliance with these standards and
applicable laws and regulations, and
− participating in management review of
the quality system.
• The blood bank/transfusion service
medical director has the authority and is
ultimately responsible for:
− all medical and technical policies and
procedures affecting laboratory personnel
and test performance
− or consulted in policies that relate to the
care and safety of donor and/or
transfusion recipients.
− quality assurance, ensuring appropriate
use of resources in the transfusion service
− ensuring compliance with CSA Z902-04
Blood and blood components standard,
CSTM Standards for Hospital Transfusions
Services and any other appropriate
regulations

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LABORATORY SERVICES
FACILITY NAME(S)
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managers, supervisors, and staff are
responsible for:
− reporting to the authorities defined in the
facility’s structure, and
− following all policies, processes, and
procedures as written.
• The Blood Transfusion Committee is
responsible for:
− Defining blood transfusion policies as
appropriate to local activities
− Ensuring regular evaluation of blood
transfusion practices
− Setting criteria for ordering practices,
utilization, administration policies and the
ability of service to meet recipient needs
− Recommending corrective measures
− Disseminating transfusion medicine
information and education
− Evaluating reports of adverse transfusion
events and transfusion errors within the
facility(ies) and also federally and
provincially
− Reviewing available alternatives to
allogeneic blood transfusion
Medical Director The blood bank/transfusion service has a

medical director who is a licensed physician and
qualified by training and/or experience in blood
banking/transfusion services.
Emergency Operations The blood bank/transfusion service maintains

Plans emergency operations plans to respond to the
effects of disasters.
Quality System The blood bank/transfusion service maintains a

defined, documented, and implemented quality
system and trains all personnel in its application.
Quality Specialist The blood bank/transfusion service has

designated a person—who reports to executive
management—to supervise the quality system.

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LABORATORY SERVICES
FACILITY NAME(S)
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Management Reviews The blood bank/transfusion service management

assesses the effectiveness of the quality system
through scheduled management reviews.
Policies, Processes, and The blood bank/transfusion service maintains

Procedures a process for the approval of all medical and
technical policies, processes, and procedures.
The blood bank/transfusion service maintains
written quality and operational policies,
processes, and procedures.
The blood bank/transfusion service staff
members are trained to follow the written
policies, processes, and procedures.
a process for capturing justification and pre-
approval of any exceptions to established
policies, processes, and procedures.
Supporting Documents:
Identification
Document Title Location
Number
Blood bank/Transfusion Service
Organization Chart

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LABORATORY SERVICES
FACILITY NAME(S)
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5.2 QSE: Resources Policy
Policy The blood bank/transfusion service provides

adequate resources to perform, verify, and
manage all activities in the blood
bank/transfusion service. Where necessary, the
blood bank/transfusion service collaborates with
the Human Resources Department in these
processes.

and procedures to effectively manage the blood
bank/transfusion service resources.
Responsibility • The Human Resources Department is

responsible for:
− Assessing candidate resumes for
qualifications and work experience prior to
the interviewing process to identify
appropriate candidates
− Maintaining records of staff qualifications,
previous work experience and
documentation of facility required
orientation and training requirements
Medical Director is responsible for:
− Ensuring sufficient staffing complements
to carry out all tasks according to
operating procedures
manager/supervisor is responsible for:
− Ensuring personnel have documented
education, training, experience, and skills
to perform assigned duties prior to hire
− Developing and maintaining job
descriptions of all positions within the
Blood Transfusion Service
− Ensuring appropriate training is provided,
assessed, documented and approval given
for each staff member to perform
procedures
− Ensuring competency assessment is
performed, assessed and documented

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LABORATORY SERVICES
FACILITY NAME(S)
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staff is responsible for:
− Performing all processes and procedures
according to defined policies, processes
and standard operating procedures
− Performing all requirements of the training
process, requesting retraining as required
and determining readiness for competency
assessment
Human Resources The blood bank/transfusion service employs an

adequate number of qualified individuals.
Qualifications and Job descriptions define appropriate qualifications

(defined as: education, training, and experience)
Job Descriptions
for each position and are kept current.
Personnel performing critical tasks are qualified
based on appropriate education, training, and
experience.
Training The blood bank/transfusion service maintains a

process for identifying training needs.
The blood bank/transfusion service also
maintains a process for training all personnel
who perform activities affecting quality.
Competence The blood bank/transfusion service maintains

processes for evaluating competence after initial
training and for evaluating continued
competence at specified intervals.
Personnel Records The blood bank/transfusion service and/or

Human Resources maintains personnel records
for each employee.
The following records are kept for those
authorized to perform or review critical
processing steps:
– names,
– signatures,
– initials or identification codes,
– inclusive dates of employment, and
– supporting documents.

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LABORATORY SERVICES
FACILITY NAME(S)
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Identification
Number

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FACILITY NAME(S)
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5.3 QSE: Equipment Policy
Policy The blood bank/transfusion service identifies

equipment that is critical to the provision of
blood, blood components, [tissue], and services
and ensures that calibration, maintenance, and
monitoring of equipment conforms to these
standards and other specified requirements.

bank/transfusion service instruments,
equipment, and computer systems.
Responsibility • The Biomedical Engineering

department is responsible for:
− Providing services relating to repair and
calibration of equipment
• The Refrigeration department is
responsible for:
− Providing services relating to repair and
calibration of refrigeration equipment
• The Contracted Equipment
Maintenance supplier is responsible for:
− Providing services related to repair and
calibration of equipment as defined in an
agreement contract with the facility
• The Information Technology (IT)
department is responsible for:
− Providing services for repair and upgrades
to the computer system and associated
devices used as the information system of
the facility
− Selection and procurement of equipment
− Ensuring validation is performed and
acceptable prior to initiation of equipment
− Reviewing and acceptance of validation
protocols
− Ensuring acceptability of installation,
maintenance and calibration results

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LABORATORY SERVICES
FACILITY NAME(S)
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− Reviewing and acceptance of calibration,

maintenance and conformance of
equipment records
− Developing, reviewing and maintaining the
equipment essential of the quality system
Quality Specialist is responsible for:
− Equipment identification
− Developing and ensuring performance of
validation protocol
− Assessing acceptability of validation
results and follow-up actions
− Ensuring performance of installation,
maintenance and calibration procedures
prior to use, after repairs and at
prescribed intervals
− Assessing acceptability of calibration
− Assessing acceptability of maintenance
− Developing, reviewing and maintaining all
policies, processes, procedures, forms and
documents related to preparation and
maintenance of the equipment essential
− Performing validation processes and
procedures according to defined standard
operating procedures
− Interpreting results for acceptability and
immediately reporting all non conforming
results to the Quality Specialist
− Performing preventative maintenance
procedures according to defined policies,
processes and standard operating
procedures
− Interpreting results for acceptability and
immediately reporting all non conforming
results to the Quality Specialist
− Performing corrective actions according to
standard operating procedures and/or

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LABORATORY SERVICES
FACILITY NAME(S)
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direction from the Quality

Specialist/Laboratory Manager/Supervisor
− Ensuring that all validation and
preventative maintenance records are
forwarded to the Quality Specialist upon
completion
− Performing all quality control procedures
according to defined standard operating
procedures
Equipment Selection − The blood bank/transfusion service

maintains a process for defining the
selection criteria for equipment.
− Equipment is qualified for its intended
use.
− Devices and equipment are validated.
− Equipment (including computer hardware)
is used in conformance with
manufacturer’s written instructions.
Equipment Identification Critical equipment is given unique identification.
Monitoring The blood bank/transfusion service maintains a

process and schedule for monitoring all critical
equipment
Calibration Critical equipment is calibrated and adjusted

− prior to use,
− after activities that may affect the
calibration, and
− at prescribed intervals.
Calibration equipment is used that has adequate
accuracy and precision.
Conformance Assessment of conformance of blood, blood

components, [tissue], and services is made
when equipment is found to be out of
calibration.
Storage Devices − The blood bank/transfusion service

maintains storage devices that have the
capacity and design to ensure that the
proper temperature is maintained.

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LABORATORY SERVICES
FACILITY NAME(S)
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− The blood bank/transfusion service

maintains a process to monitor and
record the temperature of storage
devices.
Warming Devices Warming devices are equipped with a visible

thermometer and a warning system to detect
malfunctions and prevent hemolysis or other
damage.
Alarm Systems Storage devices are equipped with alarm

systems.
The blood bank/transfusion service maintains a
process for immediate investigation and
appropriate corrective action upon activation of
the alarm system.
Equipment Records The following records are kept:

− equipment identification,
− results of calibrations and follow-up
actions,
− results of maintenance and follow-up
actions,
− temperature readings of temperature-
regulated equipment, and
− validation results
Identification
Number

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LABORATORY SERVICES
FACILITY NAME(S)
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5.4 QSE: Supplier and Customer Issues Policy
Policy The blood bank/transfusion service evaluates

the ability of suppliers of critical materials and
services to consistently meet agreed upon
requirements.

and procedures to effectively manage the
quality of the blood bank/transfusion service
purchased critical materials and services.
Responsibility • The [non-Blood Bank/Transfusion Service]

Department is responsible for:
−
− Determining qualification requirements
and acceptability of vendors
− Reviewing, changing and accepting
vendor agreements
− Final review and acceptance of
documentation related to receipt,
inspection and testing of incoming critical
supplies and services
− Review of deviations, corrective actions
taken and assessment of appropriateness
− Developing, reviewing and maintaining
the supplier and customer issues essential
of the quality system
Quality Specialist is responsible for:
policies, processes, procedures, forms
and documents related to preparation and
maintenance of the supplier and customer
issues essential
− Reviewing documentation related to
receipt, inspection and testing of
incoming blood, blood components,
critical supplies and services
− Determining appropriate corrective action
for any deviations related to incoming

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LABORATORY SERVICES
FACILITY NAME(S)
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blood, blood components, critical supplies

and services
− Ensuring non conforming blood, blood
components and critical supplies are
quarantined according to established
procedures
− Contacting suppliers as necessary for
advice and reconciliation
− Assessing complaints and determining
corrective actions as appropriate in
accordance with management
− Performing receipt, inspection and testing
of incoming, blood, blood components,
critical supplies and services according to
defined policies, processes and
procedures
− Interpreting testing results, reporting non
conforming results and damaged supplies
to the Quality Specialist and forwarding
completed documentation to the Quality
Specialist
Supplier Qualification The blood bank/transfusion service evaluates

and participates in the selection of suppliers.
Tests or services are performed in laboratories
that are:
• accredited by Health Canada, AABB, ISO or
other equivalent accrediting body,
• licensed and/or registered by the Health
Canada (FDA).
process to ensure that containers and solutions
used for collection, preservation, and storage of
blood and components meet or exceed
applicable Health Canada (FDA) criteria.
process to ensure that reagents used for
required tests on blood samples meet or exceed
applicable Health Canada (FDA) criteria.

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Agreements The blood bank/transfusion service maintains a

process to define supplier and customer
expectations in agreements for obtaining or
providing blood, blood components, [tissue],
critical materials, or services.
process to review and incorporate changes in
agreements for obtaining or providing blood,
blood components, [tissue], critical materials, or
services.
Incoming Receipt, The blood bank/transfusion service maintains

Inspection, processes for receiving, inspecting, and testing
(as necessary) incoming blood, blood
and Testing
components, [tissue], plasma derivatives, and
critical materials before acceptance or use.
Failure to Meet The blood bank/transfusion service maintains a

Requirements process to report to management with
contracting authority instances when a supplier
fails to meet specified requirements.
Records Records are kept of the following:

− qualifications of suppliers,
− agreements,
− incoming receipt, inspection, and testing
(as needed), and
− qualifications of containers, solutions
and reagents.
Identification
Number

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LABORATORY SERVICES
FACILITY NAME(S)
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5.5 QSE: Process Control Policy
Policy The blood bank/transfusion service

maintains policies, validated processes and
procedures to build quality into the provision of
blood, blood components, tissue, and services,
and carries out these activities under controlled
conditions.

bank/transfusion service entire path of workflow
from donation to final dispensation.

Medical Director is responsible for:
− The approval of all medical and technical
policies, processes and procedures
affecting laboratory personnel and test
performance
− Or consulted in the development of all
policies related to the care and safety of
recipients and donors as appropriate
− All quality assurance and appropriate use
of resources within the blood bank/blood
transfusion service
− Ensuring compliance with the CSA Z902-
04 Blood and blood components standard
− Developing, reviewing and maintaining
the process control essential of the quality
system
− Ensuring all policies, processes and
procedures for identification,
documentation, review and approval
provide control of all processes
− Ensuring an appropriate proficiency
testing program is in existence with
review and approval processes
− Ensuring a quality assurance program is
in existence with review and approval
processes

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FACILITY NAME(S)
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− Critical supplies and/or suppliers are

controlled
− Traceability of all critical elements is
maintained
• The Quality Specialist is responsible for:
policies, processes, procedures, forms
and documents related to preparation and
maintenance to ensure all processes are
in control
− Develop, advocate performance, review,
initiate corrective action(s) and approve
all validation activities for policies,
processes and procedures
− Ensuring appropriate quarantine
processes are initiated when appropriate
− Review, initiate corrective action(s) (as
appropriate) and/or approve all quality
control and proficiency testing
− Ensures proficiency testing is performed
by all staff and documentation of
performance is maintained
staff are responsible for:
− Performing processes and procedures
− Interpreting testing results, reporting non
conforming results to the Quality
Specialist and forwarding completed
documentation to the Quality Specialist
for all quality control testing, blood and
blood components, critical supplies or
services
− Performing any corrective actions as
defined by standard operating procedures
or by the Quality Specialist/Laboratory
Manager/Supervisor
− Performing proficiency testing according
to defined regimens, interpreting results
obtained and reporting any unusual or
non conforming results to the Quality

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LABORATORY SERVICES
FACILITY NAME(S)
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Specialist
− Identifying and informing the Quality
Specialist of any problems, issues, etc.
related to policies, processes or
procedures that may affect the safety and
quality of blood, blood components,
services
Change Control The blood bank/transfusion service maintains a

process to develop new processes and
procedures and to change existing ones.
New or changed processes or procedures are
validated prior to implementation.
New or changed processes or procedures are
implemented under controlled conditions.
Proficiency Testing The blood bank/transfusion service participates

in a proficiency testing program for each analyte
tested by the facility.
The blood bank/transfusion service has a system
to determine the accuracy and reliability of test
results for which no CMS-approved program is
available.
When expected results are not achieved, results
are reviewed and/or corrective action is taken
where appropriate.
Quality Control The blood bank/transfusion service maintains a

comprehensive quality control program to verify
reagents, equipment, and procedures function
as expected.
Results are reviewed and/or corrective action
taken where appropriate.
Use of Materials The blood bank/transfusion service uses all

materials in accordance with the manufacturers’
written instructions.
All deviations from manufacturer’s written
instructions are tested and validated with
appropriate documentation and acceptance
criteria prior to implementation.
Sterility The blood bank/transfusion service uses aseptic

methods to minimize the risk of microbial
contamination of blood, blood components,

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tissue, or plasma derivatives.

The blood bank/transfusion service uses sterile
and pyrogen-free transfusion equipment and
solutions that come into contact with blood,
blood components, tissue, and plasma
derivatives.
The blood bank/transfusion service uses single-
use transfusion equipment whenever possible.
Identification and The blood bank/transfusion service maintains a

Traceability means to identify individuals who perform each
critical step in collection, processing,
compatibility testing, and distribution of blood
and blood components.
identification and traceability of all blood, blood
components, tissue, plasma derivatives, critical
materials, laboratory samples, and donor and
patient records.
processes for labeling processed components
and modified components.
Inspection The blood bank/transfusion service maintains

processes for handling, storage, distribution,
and transportation of blood, blood components,
[tissue,] samples, and critical materials to
prevent damage, limit deterioration, and meet
requirements for storage, transportation, and
expiration.
Operations The blood bank/transfusion service maintains

written processes and procedures for all
operations in its path of workflow.

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FACILITY NAME(S)
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5.6 Overall Blood Bank/Blood Transfusion Service Path of Workflow
Receiving Requests Pretransfusion Issue Administration Record

Inventory Testing Management
Identification
Number

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LABORATORY SERVICES
FACILITY NAME(S)
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5.7 QSE: Documents and Records Policy
Policy The blood bank/transfusion service ensures

documents are identified, reviewed, approved,
retained and records are created, stored, and
archived in accordance with record retention
policies.

and procedures to create, identify, approve,
review, retain, store, and archive the blood
bank/transfusion service documents and
records.

− Developing, reviewing, approving and
maintaining processes for document
control including identification, review,
approval, retention, storage and archival
processes
− Reviewing and approving all documents
generated through quality assurance
procedures, training, competency,
proficiency testing, changes and revision
to policies, processes and procedures
− Development of policies, processes and
procedures relating to the document
control essential
− Reviewing documents generated through
quality assurance procedures, equipment
preventative maintenance, validation,
training, competency and proficiency
testing for completeness and acceptability
− Reviewing documents generated through
corrective actions and assessing for
acceptability
− Ensuring complete traceability of all blood
and blood components from receipt to
dispense or discard and including all
quality assurance testing documentation
− Ensuring complete traceability of all
critical supplies and services from receipt

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through to use, including all quality

assurance testing documentation
− Ensuring all policies, processes,
procedures, documents and records are
reviewed, updated, stored, retained and
archived according to described document
control processes
• The blood bank/blood transfusion
service staff are responsible for:
− Performing document control processes
− Ensuring documents and records are
completed according to defined
procedures and forwarded to the Quality
Specialist
− Ensuring all corrective actions taken are
documented, interpreted and forwarded
to the Quality Specialist
Master List The blood bank/transfusion service maintains a

master list of policies, processes, procedures,
forms, and labels.
Document Formats The blood bank/transfusion service uses

standardized formats for policies, processes, and
procedures.
Review and Approval The blood bank/transfusion service maintains a

process for review and approval of new and
revised documents before they are used.
Annual Review The blood bank/transfusion service maintains a

process for annual review of unchanged
documents.
Current Documents The blood bank/transfusion service maintains a

process to ensure only current and valid
documents are available at locations where
activities essential to meeting regulatory and
accreditation requirements are performed.
Obsolete Documents The blood bank/transfusion service maintains a

process to identify and archive obsolete
documents.

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Creation of Records The blood bank/transfusion service provides

instructions so the actual result of each test
observed is recorded immediately and the final
interpretation is recorded upon completion of
testing.
Record Management The blood bank/transfusion service maintains

processes and procedures for identifying,
collecting, indexing, accessing, filing, storage,
and disposition of its records.
processes and procedures to ensure records are
complete, retrievable in a period of time
appropriate to the circumstances, and protected
from accidental or unauthorized destruction or
modification.
processes for access to records to prevent
unauthorized access and ensure confidentiality.
record-keeping system that allows for:
− traceability of any unit of blood or blood
component from its source to final
disposition,
− review of records applying to the specific
component, and
− investigation of adverse reactions
manifested by the recipient.
Record Retention The blood bank/transfusion service follows a

record retention schedule which meets
applicable regulatory, accreditation, and
organizational requirements.
Copies of Records The blood bank/transfusion service maintains a

process for making, identifying, and verifying
copies of records prior to the destruction of
original records.
Computer System The computer system is used only for the

applications that have been designed, tested,
and validated.
processes and procedures for:

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• The introduction of new software,

hardware, or databases, and
• Modifications of existing software,
hardware, software, or databases.
Computer System Records The blood bank/transfusion service maintains

records of the following:
− validation of system software, hardware,
databases, and user-defined tables,
− fulfillment of applicable life-cycle
requirements,
− numerical designation of system versions
with inclusive dates of use, and
− monitoring of data integrity for critical
data elements.
Alternative System The blood bank/transfusion service maintains an

alternative system and periodically tests it to
Computer down time
ensure continuous operation in the event that
Procedures
computerized data and computer-assisted
functions are unavailable.
Computer System Personnel responsible for the management of

Regulations the computer systems comply with the
regulations that affect the systems’ use.
Back-Up The blood bank/transfusion service and/or IT

department maintains processes and procedures
for routine back-up of all critical data.
Identification
Number

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5.8 QSE: Deviations, Nonconformance

and Complications Policy
Policy The blood bank/transfusion service identifies,

assesses, investigates, and monitors deviations
from or failures to meet specified requirements
and reports deviations in accordance with
specified requirements including risk
management, Canadian Blood Services, Health
Canada and Nova Scotia Provincial Blood
Coordinating Program as appropriate.

and procedures to document, investigate, track,
analyze, and take corrective action on events,
components, or services that fail to meet
specified requirements.

medical director is responsible for:
procedures meet or exceed regulatory
requirements
− Consulted in the assessment and
recommendations for corrective actions
− Ensuring timely evaluation of adverse
reactions and appropriate reporting
according to defined processes
− Pre-approval of exceptions to policy,
processes and procedures on a case-by-
case basis including documentation
− The development of policies, processes
and procedures to identify, assess,
investigate, and monitor deviations and
non conformances related to blood, blood
components, critical supplies and services
− The assessment and acceptability of all
reports, corrective actions and
documentation
− The development of appropriate auditing
mechanisms to ensure compliance with
policies, processes, procedures and

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regulating bodies
• The Blood transfusion committee is
responsible for:
− Evaluation of adverse reaction and
transfusion error data
− Evaluation of provincial and federal reports
of adverse events
− Recommendations for corrective measures
and practice changes
− Ensuring appropriate audits are conducted
on a routine basis
− Trending data and developing reports
related to deviations, non conformances,
errors and accidents
− Ensuring non conforming blood, blood
components, critical supplies and services
are quarantined according to defined
processes
− Ensuring all appropriate notifications are
made in response to adverse reactions
according to defined processes
maintenance of the deviations, non
conformance and complications essential
− Assessment of all deviation reports,
determination and implementation of
corrective actions and approval of
corrective action reports
− Forwarding all reports for final review and
approval to the blood bank/transfusion
service manager/supervisor
service staff is responsible for:
− Documenting and implementing corrective
action(s) as defined by policies, processes
and standard operating procedures and/or
by the Quality Specialist/Laboratory
Manager/Supervisor.

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FACILITY NAME(S)
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− Forwarding all completed documents to

the Quality Specialist
− Reporting all non conformances, errors
and accidents immediately upon discovery
to the Quality Specialist
− Quarantining blood, blood components,
plasma derivatives, critical supplies and
equipment according to defined policies,
processes and procedures or by direction
of the Quality Specialist/Laboratory
Manager/Supervisor
Nonconformances The blood bank/transfusion service maintains

processes and procedures for the evaluation and
disposition of nonconforming:
− blood, blood components, [tissue], plasma
derivatives, critical materials, services
These processes and procedures ensure that any
of the above that do not conform with specified
requirements are prevented from unintended
distribution or use, and that any nonconforming
blood, blood components, plasma derivatives
[and tissue] are segregated.
Quarantine, Retrieval, and The blood bank/transfusion service maintains

Recall processes and procedures for
• quarantine, retrieval, and recall of
nonconforming blood, components, [and
tissue], and
• notification of nonconforming services.
Released Nonconforming The blood bank/transfusion service maintains

Blood, Components, [or processes and procedures for evaluating blood,
Tissue] components, [or tissue] that are determined
after release not to conform with specified
requirements to determine the effect of the
nonconformance on the quality of the product.
Fatal Reactions The blood bank/transfusion service maintains

processes and procedures for reporting serious
and fatal donor or transfusion recipient adverse
reactions to outside agencies as required
including Health Canada, Canadian Blood
Services and Nova Scotia Provincial Blood
Coordinating Program.

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LABORATORY SERVICES
FACILITY NAME(S)
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Adverse Donor Reactions The blood bank/transfusion service maintains

processes and procedures to identify, assess,
investigate, and monitor adverse reactions to
the blood donation process during autologous
blood donations.
Suspected Recipient The blood bank/transfusion service maintains

Complications processes and procedures for the detection,
reporting, and evaluation of suspected
complications of transfusion including:
• immediate notification of the transfusion
service and responsible physician,
• prompt evaluation of all suspected
transfusion complications,
• review by the blood bank or transfusion
service medical director, and
• immediate notification of Canadian Blood
Services, the Nova Scotia Provincial Blood
Coordinating Program or facility collecting
autologous donations when a complication
occurs that is suspected to be due to an
attribute of the donor or unit of blood or
component.
Immediate Complications The blood bank/transfusion service maintains

processes and procedures for the evaluation of
immediate transfusion complications in a
manner not to delay proper clinical management
of the patient.
The process indicates under which
circumstances additional testing is required and
what testing will be performed.
Interpretation of The blood bank/transfusion service maintains a

Immediate Complications process and procedures for interpreting the
evaluation, documenting in the patient’s medical
record, and where serious, immediate reporting
to the patient’s physician.
Delayed Transfusion The blood bank/transfusion service maintains a

Recipient Complications process and procedures for performance of
testing, evaluation, and reporting to the
patient’s physician if a delayed transfusion
reaction is detected or suspected.

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FACILITY NAME(S)
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Look-back The blood bank/transfusion service maintains a

process and procedures for identifying recipients
of blood or components from donors
subsequently found to have or be at risk for
relevant transfusion-transmitted infections and
to notify the recipient’s physician and/or
recipient, where appropriate.
Transfusion-Transmitted The blood bank/transfusion service maintains a

Diseases process for reporting and investigating
suspected cases of transfusion-transmitted
diseases and for reporting the identity of any
implicated donor units to the supplier.
Records The blood bank/transfusion service maintains

records of the following:
− reported deviations,
− nature of nonconformances and
subsequent actions taken for
nonconforming blood, blood
components, [tissue], plasma
derivatives, critical materials, and
services,
− suspected transfusion complications,
and
− interpretations of the evaluations of
suspected immediate and delayed
complications.
Identification
Number

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LABORATORY SERVICES
FACILITY NAME(S)
Page 32 of 40
5.9 QSE: Assessments Policy
Policy The blood bank/transfusion service obtains

external assessments at defined intervals and
schedules and conducts internal assessments of
operations and the quality system.

and procedures that give the blood bank/blood
transfusion service data and information about
its :
− compliance with requirements
− effectiveness of its operations and quality
system.
Responsibility • Executive management is responsible

to:
− Review all internal and external audit
reports
− Or consulted in the development of
internal and external assessment policies,
− Ensuring compliance with regulatory
requirements
− Reviewing audit reports and consulted in
determining appropriate corrective
action(s) to improve performance
− Or consulted in accreditation audit
responses to regulatory bodies
• The blood transfusion committee is
responsible for:
− Determining intervals for internal audits
− Assessing audit reports related to blood
transfusion practice and recommend
appropriate corrective action(s) or
changes in practice
• The internal auditing team is
responsible for:
− Conducting a full quality system audit at
defined intervals according to policies,

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FACILITY NAME(S)
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− Generating a report of the audit outcomes
• The blood bank/transfusion services
manager/supervisor are responsible
for:
− Developing policies, processes and
procedures defining internal and external
auditing requirements
− Reviewing audit reports and determining
corrective actions if required
− Developing appropriate response reports
to accrediting organizations as appropriate
− Determining appropriate audits according
to deviation, non conformance, error and
accident trending data
maintenance of the assessments essential
− Reviews all audit reports for determination
of effective corrective action(s) in
response to audit deficits
− Initiates corrective action(s) as
appropriate
− Re-audits process after defined period to
determine effectiveness of initiated
corrective action(s)
− Performing processes and procedures
− Initiate corrective action(s) defined by
processes and procedures and/or
according to requirements of the Quality
− Providing information and performing
standard operating procedures upon
request from auditing teams, accreditors,
etc. during an audit process

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LABORATORY SERVICES
FACILITY NAME(S)
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− Collecting audit data internally as required

by the Quality Specialist

Management of
process to review results of external and internal
Assessment Results
assessments with personnel in the areas that
were assessed.
Corrective Actions Corrective actions are developed and

implemented using a defined problem resolution
process. The implementation and effectiveness
of corrective actions are verified.
Review of External and The blood bank/transfusion service maintains a

Internal Assessments process for review by executive management of
results of external and internal assessments and
associated corrective actions.
Blood Utilization The blood bank/transfusion service maintains a

blood transfusion committee that monitors
transfusion practices for all categories of blood
components.
Identification
Number

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LABORATORY SERVICES
FACILITY NAME(S)
Page 35 of 40
5.10 QSE: Process Improvement through

Corrective and Preventive Action Policy
Policy The blood bank/transfusion service collects and

analyzes data about its quality system to
determine where preventive and corrective
actions are needed and follows up on
implementing the necessary preventive or
corrective actions.

and procedures for identification and
development of preventive actions for
anticipated quality problems and corrective
actions for known quality problems.

procedures meet regulatory requirements
− Or consulted in the development of
appropriate policies, processes and
procedures to facilitate process
improvement
manager and supervisor are responsible
for:
− Developing policies, processes and
procedures defining process improvement
mechanisms through corrective and
preventive actions
− Reviewing and approving all process
improvement initiates and accompanying
documentation
− Determining quality indicators to be
assessed and monitored
maintenance of the process improvement
essential
− Developing, collecting, assessing and
reporting quality indicator data as

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LABORATORY SERVICES
FACILITY NAME(S)
Page 36 of 40
appropriate
− Developing and initiating appropriate
improvement processes and procedures as
determined through quality indicators
− Developing, initiating and reporting
process audits as defined by processes
and procedures
− Performs investigations of incidents,
errors, accidents, non conformances,
customer complaints and other issues as
appropriate and develops reports
according to defined processes and
procedures
− Ensures corrective action(s) are reviewed
for acceptability and forwards to blood
bank/transfusion service
manager/supervisor for approval
− Conducts reassessment of corrective
action(s) taken to ensure expectations are
met
− Participating in identifying and
implementing preventive and corrective
actions when asked to do so.
− Performing corrective action(s) as
requested by the Quality
− Reporting and documenting errors,
accidents, non conformances, complaints
and other issues to the Quality Specialist
Documenting Events The blood bank/transfusion service maintains a

process for documenting:
and Complaints
− incidents, errors, accidents, and other
issues that may require reporting to
outside organizations,
− reports of nonconformances discovered
during daily work operations, and
− complaints from donors, patients, or

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LABORATORY SERVICES
FACILITY NAME(S)
Page 37 of 40
health care professionals.
Investigation of The blood bank/transfusion service maintains a

process for investigating nonconformances
Nonconformances
related to:
and Complaints
− blood, blood components,
− tissue,
− plasma derivatives, and
− critical materials and services.
process for investigating each customer
complaint.
Determining Corrective The blood bank/transfusion service uses a

Action defined process for determining the corrective
action needed to eliminate the cause(s) of
nonconforming incidents, errors, and accidents.
Evaluating Corrective The blood bank/transfusion service evaluates

Action corrective actions taken to verify their
effectiveness.
Identifying Potential The blood bank/transfusion service reviews the

Problems following sources of information to detect
opportunities for actions that would prevent
potential problems:
− results of internal/external assessments,
− complaint files,
− results of proficiency testing,
− quality control records, and
− quality indicator data.
Determining Preventive The blood bank/transfusion service uses a

Action defined process for determining the preventive
action required to eliminate the cause(s) of
potential problems.
Evaluating Preventive The blood bank/transfusion service:

Action
− initiates needed preventive actions,
− applies controls to the involved
processes, and
− evaluates the preventive actions taken

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LABORATORY SERVICES
FACILITY NAME(S)
Page 38 of 40
to verify their effectiveness.
Quality Monitoring The blood bank/transfusion service has

identified quality indicators to monitor the
performance of selected blood bank/transfusion
service processes and maintains processes and
schedules for collection and evaluation of quality
indicator data.
Identification
Number

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LABORATORY SERVICES
FACILITY NAME(S)
Page 39 of 40
5.11 QSE: Facilities and Safety Policy
Policy The blood bank/transfusion service provides safe

and adequate environmental conditions in the
workplace that meet local, provincial, and
federal regulations, where applicable.

and procedures needed to implement and
monitor safe work practices to protect donors,
patients, employees, and volunteers.
Responsibility All blood bank/transfusion service medical

and technical staff are responsible for:
− Following all required safety practices and
procedures and to report unsafe conditions
in the workplace.
− Participating in any facility requirements
for safety training and competency
assessment
Safe Environment The blood bank/transfusion service has designed

and organized its quarters, environment, and
equipment, and implemented appropriate
processes to maintain safe operations.
Biologic, Chemical, The blood bank/transfusion service maintains a

process for monitoring adherence to biological
and Radiation Safety
and chemical safety requirements and
standards.
Discard of Blood, The blood bank/transfusion service maintains

procedures for the handling and discard of
Components [and Tissue]
blood, components [and tissue] that minimize
the potential for human exposure to infectious
agents.

QUALITY MANUAL
LABORATORY SERVICES
FACILITY NAME(S)
Page 40 of 40
Identification
Number

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QUALITY MANUAL

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

This document describes the overall quality system used by

LABORATORY DEPARTMENT APPLICABLE STANDARD/GUIDELINES

The quality manual is distributed to [location of all manuals].

The quality manual is reviewed and revisions made on a yearly basis to

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

3.0 GENERAL INFORMATION:

3.3 ORGANIZATIONAL VALUES:

List all values of your organization/district.

3.4 ORGANIZATION IDENTITY:

Facility Name Location

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

4.0 QUALITY SYSTEM:

4.1 QUALITY POLICY:

4.2 QUALITY OBJECTIVES:

4.3 QUALITY SYSTEM ESSENTIALS:

(Refer to Section 5 for more detailed information.)

4.4 QUALITY PLAN

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

5.0 QUALITY SYSTEM ESSENTIALS:

See following Quality System Essential Charts.

5.1 QSE: Organization Policy

Policy The blood bank/transfusion service has

Purpose This policy provides direction for the processes

Responsibility • The blood bank/transfusion service

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

• The blood bank/transfusion service

Medical Director The blood bank/transfusion service has a

Emergency Operations The blood bank/transfusion service maintains

Quality System The blood bank/transfusion service maintains a

Quality Specialist The blood bank/transfusion service has

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

Management Reviews The blood bank/transfusion service management

Policies, Processes, and The blood bank/transfusion service maintains

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

5.2 QSE: Resources Policy

Policy The blood bank/transfusion service provides

Purpose This policy provides direction for the processes

Responsibility • The Human Resources Department is

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

• The blood bank/transfusion service

Human Resources The blood bank/transfusion service employs an

Qualifications and Job descriptions define appropriate qualifications

Training The blood bank/transfusion service maintains a

Competence The blood bank/transfusion service maintains

Personnel Records The blood bank/transfusion service and/or

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

5.3 QSE: Equipment Policy

Policy The blood bank/transfusion service identifies

Purpose This policy provides direction for the processes

Responsibility • The Biomedical Engineering

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

− Reviewing and acceptance of calibration,

EFFECTIVE DATE/DOCUMENT NUMBER/VERSION

direction from the Quality

Equipment Selection − The blood bank/transfusion service

Equipment Identification Critical equipment is given unique identification.

Monitoring The blood bank/transfusion service maintains a

Calibration Critical equipment is calibrated and adjusted

Conformance Assessment of conformance of blood, blood