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



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

Blood Transfusion Service

• CSA Z902-04 Blood and blood component standard

• Canadian Society for Transfusion Medicine Standards for Hospital Transfusion Services Version 1-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 Chemistry Microbiology Histotechnology

• CSA Z15189-03 Medical Laboratories: Particular Requirements for Quality and 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].




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




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].




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




• The blood bank/transfusion service 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 Plans

The blood bank/transfusion service maintains 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.




Management Reviews The blood bank/transfusion service management assesses the effectiveness of the quality system through scheduled management reviews.

Policies, Processes, and Procedures

The blood bank/transfusion service maintains 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.

The blood bank/transfusion service maintains a process for capturing justification and pre-approval of any exceptions to established policies, processes, and procedures.

Supporting Documents:

Identification

Number Document Title Location

Blood bank/Transfusion Service Organization Chart




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.

Purpose This policy provides direction for the 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

• The blood bank/transfusion service Medical Director is responsible for:

− Ensuring sufficient staffing complements to carry out all tasks according to operating procedures

• The blood bank/transfusion service 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




• The blood bank/transfusion service

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

Job descriptions define appropriate qualifications (defined as: education, training, and experience) 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.





Identification Number

Document Title Location




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.

Purpose This policy provides direction for the processes and procedures to effectively manage the blood 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




− Reviewing and acceptance of calibration,

maintenance and conformance of equipment records

− Developing, reviewing and maintaining the equipment essential of the quality system

• The blood bank/transfusion service 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 results and follow-up actions

− Assessing acceptability of maintenance results and follow-up actions

− Developing, reviewing and maintaining all policies, processes, procedures, forms and documents related to preparation and maintenance of the equipment essential

• The blood bank/transfusion service staff is responsible for:

− 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




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.




− 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







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.

Purpose This policy provides direction for the processes 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

• The blood bank/transfusion service Quality Specialist is responsible for:

− Developing, reviewing and maintaining all 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




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

• The blood bank/transfusion service staff is responsible for:

− 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).

The blood bank/transfusion service maintains a 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.

The blood bank/transfusion service maintains a process to ensure that reagents used for required tests on blood samples meet or exceed applicable Health Canada (FDA) criteria.




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.

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

Incoming Receipt, Inspection,

and Testing

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

Failure to Meet Requirements

The blood bank/transfusion service maintains a 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.







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.

Purpose This policy provides direction for the processes and procedures to effectively manage the blood bank/transfusion service entire path of workflow from donation to final dispensation.

Responsibility • The blood bank/transfusion service 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




− Critical supplies and/or suppliers are

controlled

− Traceability of all critical elements is maintained

• The Quality Specialist is responsible for:

− Developing, reviewing and maintaining all 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

• The blood bank/transfusion service staff are responsible for:

− Performing processes and procedures according to defined policies, processes and standard operating 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




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,




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 Traceability

The blood bank/transfusion service maintains a means to identify individuals who perform each critical step in collection, processing, compatibility testing, and distribution of blood and blood components.

The blood bank/transfusion service maintains identification and traceability of all blood, blood components, tissue, plasma derivatives, critical materials, laboratory samples, and donor and patient records.

The blood bank/transfusion service maintains 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.




5.6 Overall Blood Bank/Blood Transfusion Service Path of Workflow

Receiving Requests Pretransfusion Issue Administration Record Inventory Testing Management







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.

Purpose This policy provides direction for the processes and procedures to create, identify, approve, review, retain, store, and archive the blood bank/transfusion service documents and records.

Responsibility • The blood bank/transfusion service manager/supervisor is responsible for:

− 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




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 according to defined policies, processes and standard operating procedures

− 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.




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.

The blood bank/transfusion service maintains 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.

The blood bank/transfusion service maintains processes for access to records to prevent unauthorized access and ensure confidentiality.

The blood bank/transfusion service maintains a 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.

The blood bank/transfusion service maintains processes and procedures for:




• 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

Computer down time Procedures

The blood bank/transfusion service maintains an alternative system and periodically tests it to ensure continuous operation in the event that computerized data and computer-assisted functions are unavailable.

Computer System Regulations

Personnel responsible for the management of 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.







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.

Purpose This policy provides direction for the processes and procedures to document, investigate, track, analyze, and take corrective action on events, components, or services that fail to meet specified requirements.

Responsibility • The blood bank/transfusion service medical director is responsible for:

− Ensuring all policies, processes and 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




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

− Developing, reviewing and maintaining all policies, processes, procedures, forms and documents related to preparation and 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

• The blood bank/blood transfusion 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.




− 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 Recall

The blood bank/transfusion service maintains processes and procedures for

• quarantine, retrieval, and recall of nonconforming blood, components, [and tissue], and

• notification of nonconforming services.

Released Nonconforming Blood, Components, [or Tissue]

The blood bank/transfusion service maintains processes and procedures for evaluating blood, 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.




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 Complications

The blood bank/transfusion service maintains 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 Immediate Complications

The blood bank/transfusion service maintains a 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 Recipient Complications

The blood bank/transfusion service maintains a process and procedures for performance of testing, evaluation, and reporting to the patient’s physician if a delayed transfusion reaction is detected or suspected.




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 Diseases

The blood bank/transfusion service maintains a 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.







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.

Purpose This policy provides direction for the processes 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

• The blood bank/transfusion service medical director is responsible for:

− Or consulted in the development of internal and external assessment policies, processes and procedures

− 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,




processes and procedures

− 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

− Developing, reviewing and maintaining all policies, processes, procedures, forms and documents related to preparation and 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 according to defined policies, processes and standard operating procedures

− Initiate corrective action(s) defined by processes and procedures and/or according to requirements of the Quality Specialist/Laboratory Manager/Supervisor

− Providing information and performing standard operating procedures upon request from auditing teams, accreditors, etc. during an audit process




− Collecting audit data internally as required

by the Quality Specialist

Management of Assessment Results

The blood bank/transfusion service maintains a process to review results of external and internal 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 Internal Assessments

The blood bank/transfusion service maintains a 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.







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.

Purpose This policy provides direction for the processes and procedures for identification and development of preventive actions for anticipated quality problems and corrective actions for known quality problems.

Responsibility • The blood bank/transfusion service medical director is responsible for:

− Ensuring all policies, processes and procedures meet regulatory requirements

− Or consulted in the development of appropriate policies, processes and procedures to facilitate process improvement

• The blood bank/transfusion service 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


− Developing, reviewing and maintaining all policies, processes, procedures, forms and documents related to preparation and maintenance of the process improvement essential

− Developing, collecting, assessing and reporting quality indicator data as




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 Specialist/Laboratory Manager/Supervisor

− Reporting and documenting errors, accidents, non conformances, complaints and other issues to the Quality Specialist according to defined policies, processes and standard operating procedures

Documenting Events

and Complaints

The blood bank/transfusion service maintains a process for documenting:

− 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




health care professionals.

Investigation of

Nonconformances

and Complaints

The blood bank/transfusion service maintains a process for investigating nonconformances related to:

− blood, blood components,

− tissue,

− plasma derivatives, and

− critical materials and services.

The blood bank/transfusion service maintains a process for investigating each customer complaint.

Determining Corrective Action

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

Evaluating Corrective Action

The blood bank/transfusion service evaluates corrective actions taken to verify their effectiveness.

Identifying Potential Problems

The blood bank/transfusion service reviews the 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 Action

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

Evaluating Preventive Action

The blood bank/transfusion service:

− initiates needed preventive actions,

− applies controls to the involved processes, and

− evaluates the preventive actions taken




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.







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.

Purpose This policy provides direction for the processes 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,

and Radiation Safety

The blood bank/transfusion service maintains a process for monitoring adherence to biological and chemical safety requirements and standards.

Discard of Blood,

Components [and Tissue]

The blood bank/transfusion service maintains procedures for the handling and discard of blood, components [and tissue] that minimize the potential for human exposure to infectious agents.








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