EHNRI Quality Manual

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

Laboratory Quality Manual Table of Contents

I. Introduction – Approval, etc

II. Introduction Documents

III. Quality Policies

IV. Operational Policies

V. Master List – Process Documents

VI. Master List – Standard Operating Procedures

VII. Reference Documents

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I. ............................................................................ INTRODUCTION Document Number Document Title Page

I -1 Introduction and Purpose I - 2 Description and Role of Departments I – 3 Vision, Mission and Value Statements I – 4 Scope of Operations

II. ........................................................................... QUALITY POLICIES

Document Number Document Title Page

QP- 1.1.1 Quality Policy Statement and Quality Goals QP-1.1.2 Director General’s Review of Quality Systems QP-1.1.3 Director General’s Review of the Quality

Manual

QUALITY SYSTEM ESSENTIALS QP-1.2.1 Documents and Records Policy QP-1.2.2 Personnel Policy QP-1.2.3 Equipment / Reagents / Supplies Policy QP-1.2.4 Purchasing and Inventory Policy QP-1.2.5 Process Control Policy QP-1.2.6 Information Management Policy QP-1.2.7 Occurrence Management Policy QP-1.2.8 Assessment Policy: Internal and External QP-1.2.9 Process Improvement Policy QP-1.2.10 Service and Satisfaction Policy QP-1.2.11 Facilities and Safety Policy

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III. ......................................................................... OPERATIONAL POLICIES

OP – 2 ORGANIZATION Document Number Document Title Page

OP-2.0 Administrative Organizational Chart OP-2.1 Department Organizational Structure OP-2.2 Department Operational Committees

Terms of Reference OP-2.2.1 Laboratory Executive Committee OP-2.2.2 Laboratory Administration Committee

OP – 3 PERSONNEL Document Number Document Title Page

Orientation, Training and Competency OP-3.1 Orientation Program OP-3.2 Training and Initial Competency OP-3.3 Competency Assessment Program OP-3.4 Continuing Education

Job Descriptions

OP – 4 DOCUMENTS & RECORDS Document Number Document Title Page

OP-4.1 Management and Numbering of Documents OP-4.2 Quality and Policy Document Template OP-4.3 Process Document Template OP-4.4 Technical Procedure (SOP) Template OP-4.5 Form Template OP-4.6 Retention Directives for Laboratory OP-4.7 Guidelines for Citing References OP-4.8 Document Creation, Review, Change and

Deletion Request Process

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OP – 5 EQUIPMENT, REAGENTS, SUPPLIES Document Number Document Title Page

OP-5.1 Balance Calibration OP-5.2 Pipette Calibration OP-5.3 Reagent Water Quality OP-5.4 Environmental Monitoring Program OP-5.5 Handling, Storage and Transport of Equipment,

Reagents and Supplies

OP-5.6 Alerts and Product Recalls OP-5.7 Centrifuge Maintenance Program

OP – 6 PROCESS CONTROLS

Document Number Document Title Page OP-6.1.1 Laboratory Path of Workflow OP-6.1.2 Specimen Acceptance and Rejection OP-6.1.3 Specimen Label Requirements OP-6.1.4 Process for Mislabeled/Unlabeled Specimens OP-6.1.5 Laboratory Test Utilization OP-6.1.6 Retention Directives – Diagnostic Material OP-6.2.1 Technical Procedures (SOPs) OP-6.2.2 Method Validation Guidelines OP-6.2.3 Reference Ranges OP-6.3.1 Critical Results Reporting OP-6.3.2 Critical Values OP-6.3.3 Discrepant and Corrected Results OP-6.3.4 Final Report

OP – 7 QUALTY ASSURANCE

Document Number Document Title Page OP-7.1 Internal QC Program OP-7.2 External QC Program OP-7.3 Planning and Selection of Quality Control Rules

and Procedures

OP-7.4 Establishing Target Values for QC OP-7.5 Documentation and Review of QC Results

OP – 8 QUALITY IMPROVEMENT Document Number Document Title Page

OP-8.1.1 Continuous Quality Improvement OP-8.1.2 Quality Improvement Plan Template OP-8.2.1 Non-conforming Laboratory Events

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OP – 9 PURCHASING AND INVENTORY Document Number Document Title Page

OP – 10 INFORMATION MANAGEMENT Document Number Document Title Page

OP – 11 FACILITIES AND SAFETY Document Number Document Title Page


TITLE: Introduction and Purpose Revision Date: Document Number: I-1 Status: Draft Section: QMS - Introduction Page: 1 of 1

NOTE: This is a CONTROLLED document for internal use only.

INTRODUCTION AND PURPOSE This Quality Manual outlines and references the policies of Ethiopian Health and Nutrition Research Institute (EHNRI)) as it relates to its commitment to the implementation of the laboratory quality management system. This Quality Manual is issued and controlled by EHNRI and defines the Quality Management System in effect across the Institute at all levels within the laboratories. It applies to all activities and personnel within the institute and conforms to relevant international standards (ISO15189/17025) for laboratory services. Its purpose is to describe and document the Quality Management System of EHNRI through Quality Policies that meet the requirements of regulations and standards for accreditation, and to ensure that the laboratory consistently delivers the highest standard of service.

This Manual serves as a reference for laboratory personnel on all Quality System matters, providing direction to general policies, processes and responsibilities that authorize and govern the creation of subsidiary quality-related documentation and activities. Many of these documents can be found within other existing manuals that are referenced throughout. All staff shall be educated in the use and application of the Quality Manual policies and be advised of any changes. The Quality Manual also provides comprehensive evidence to all customers, suppliers and employees that the EHNRI is committed to establishing and maintaining acceptable levels of measurable quality in its services. The Quality Manual is issued under the authority of the Director General and is maintained as a controlled document. The Director General is responsible for review and approval of the Quality Manual and ensuring compliance.


TITLE: Description and Role of EHNRI Revision Date: Document Number: I-2 Status: Draft Section: QMS - Introduction Page: 1 of 2


DESCRIPTION AND ROLE OF EHNRI

Ethiopian Health and Nutrition Research Institute (EHNRI)) is responsible for the provision of high level diagnostic laboratory testing services for patients and specimens referred from all Regional and Federal Health facilities. In addition to being the largest clinical laboratory it provides specialized testing and diagnostic consultation for the entire country.

EHNRI, through the authority of, and coordination by the Regional Laboratory Capacity Building Directorate (RLCBD), demonstrates and provides leadership and support to:

• Standardize integrated laboratory services for the national laboratory system • Improve the capacity of the Regional/Federal Laboratories • Expand and strengthen the External Quality Assessment Programs • Expand and strengthen standardized training programs for laboratory personnel and other health care

workers • Improve the management of equipment service and maintenance. • Develop a Laboratory networking and implementation of an LIS system

To support the efforts of ENHRI and RLCBD, each laboratory will identify a minimum of one individual to work with RLCBD to manage the Quality Program at that location. This individual will report directly to the Director of the Directorate for matters relating to quality.

Above all, EHNRI’s role is to enhance the quality system management of national laboratories.

Director General, EHNRI

Fax: +251 1127547424

Phone: +251 112754647

Website: www.ehnri.gov.et

TITLE: Description and Role of the Department Revision Date: July 31, 2008 Document Number: I-2 Status: Current Section: QMS - Introduction Page: 2 of 2

Prepared by: Eugene Smith Authority: Dr. J. G. Heathcote

NOTE: This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the electronic version prior to use.

Ethiopian Health and Nutrition Research Institute

Addis Ababa, Ethiopia

TITLE: Vision, Mission and Value Statements Revision Date: Document Number: I-3 Status: Draft Section: QMS - Introduction Page: 1 of 1


Vision

“To See Healthy, Productive and Prosperous Ethiopians”

Mission

“To protect and promote the health of the Ethiopian people by addressing

priority public health and nutrition problems through problem focused

research, public health emergency management, establishing and

maintaining quality laboratory system”

Ethiopian Health and Nutrition Research Institute (EHNRI)) is an organization that will:

• Facilitate patient testing by providing diagnostic services of the highest standard • Provide leadership in laboratory medicine in the country through continuing professional

development and consultative services • Educate the public in matters of health and diseases • Expand knowledge about health and disease through operational research • Foster a mutually respectful and safe work environment • Strengthen and manage services for Public Health Emergency • Production of biological products and vaccines • Manage effectively the resources required for the achievement of its goals. •

• We value collaboration, accountability, respect and excellence. VALUES

• We believe in working as a team within all of our laboratories and in partnership with other healthcare professionals.

• We accept responsibility for the performance of our laboratories and the effective use of our resources.

• We will treat each other with consideration and communicate with honesty and openness. • We endeavour to be leaders in the performance of diagnostic services and in our educational and

research activities.



TITLE: Scope of Operations and Services Revision Date: Document Number: I-4 Status: Draft Section: QMS - Introduction Page: 1 of 4


SCOPE OF OPERATIONS AND SERVICES Ethiopian Health and Nutrition Research Institute (EHNRI)) consists of following laboratories providing full services :

• Tuberculosis Laboratory • Parasitology • Clinical Chemistry • Clinical Bacteriology • Hematology • HIV Molecular Laboratory • Pathology • Rabies Diagnostics • Public Health Chemistry • Public Health Bacteriology • Influenza Laboratory • National Polio Laboratory • Central Reception

The laboratories at the EHNRI provide service Monday thru Friday from 0800 to 1700. Clinical Chemistry Laboratory

The Clinical Chemistry laboratory is a general laboratory performing testing in: General Chemistry (includes routine chemistry and endocrinology) The laboratory operates under the leadership and guidance of the Director of the Infectious and Non-Infectious Diseases Research Directorate.

1. General Hematology

Hematology Laboratory The Hematology laboratory is comprised of:

2. Flow Cytometry The laboratory operates under the leadership and guidance of the Director of the Infectious and Non-Infectious Diseases Research Directorate.



Clinical Bacteriology

The Clinical Bacteriology laboratory is comprised of: 1. Clinical Bacteriology 2. Molecular Bacteriology 3. Mycology 4. Media Preparation and Distribution

The laboratory operates under the leadership and guidance of the Director of the Infectious and Non-Infectious Diseases Research Directorate.

1. Clinical Parasitology

Parasitology

The Clinical Parasitology laboratory is comprised of:

2. Molecular Parasitology 3. Entomology


1. HIV Sequencing (HIV Genotype)

HIV Molecular Laboratory

The HIV Molecular laboratory is comprised of:

2. HIV Drug Resistance 3. HIV Viral Load and DNA-PCR


1. TB Culture and Sensitivity

Tuberculosis Laboratory

The Tuberculosis laboratory is comprised of:

2. TB Line Probe Assay The laboratory operates under the leadership and guidance of the Director of the Infectious and Non-Infectious Diseases Research Directorate.

1. Rabies Diagnosis

Rabies Diagnostic Laboratory

The Rabies Diagnostic laboratory is comprised of:

2. Vaccine Production and distribution The laboratory operates under the leadership and guidance of the Director of the Vaccine Production Research Directorate.



- Sample preparation and examination

Pathology Laboratory

The Pathology laboratory includes:


1. Phlebotomy

Central Reception

The centralized specimen reception is comprised of:

2. Accessioning 3. Specimen/Sample collection and receiving 4. Result Distribution The central reception operates under the leadership and guidance of the Director of the Regional Laboratory Capacity Building Directorate.

Reporting Priority Laboratory Results: High priority results are reported as each test is completed to the physician’s office, nursing unit, clinic, or referring hospital. These reports are ......... Critical results are phoned in person by the technologist or laboratory physician.

Final Printed Reports: Final copies of laboratory results are printed each day.

• Patient Registration

Laboratory Information System

Ethiopian Health and Nutrition Research Institute (EHNRI)) uses the PolyTech Laboratory Information System (LIS). Each area uses the appropriate module(s) from the LIS depending on the test menu and services offered. The modules currently available are Core, Collections, General Laboratory, Microbiology.

The LIS is involved in all aspects of the laboratory cycle including:

• Specimen Accessioning • Specimen Collections (lists, verification, …) • Specimen Receiving and Processing • Analysis (both Automated and Manual) • Reporting and Charting • Workload/Utilization Management



The LIS is also responsible for providing and storing daily and monthly audits: • Work Centre Activity Report • Daily/Monthly Workload Reports • Critical Change Reports • Chart Print Listings • Error Correction Reports • Result Review Reports

Other features or solutions implemented on the LIS include:

• Autoverification – system verification of laboratory tests that meet established criteria • Medical Device Interfaces – currently interfaced to different medical laboratory devices in the

laboratories at all sites



TITLE: Quality Policy Statement and Quality Goals Revision Date: Document Number: QP-1.1.1 Status: Draft Section: Quality Management System Page: 1 of 1


Purpose To define the intentions and direction of the Ethiopian Health and Nutrition Research Institute’s quality management system (QMS) in a quality policy statement.

Policy

EHNRI shall outline its commitment to good professional practice, compliance with continuous improvement of the QMS, the scope of its service and the objectives and goals of the QMS by establishing a Quality Policy Statement and Quality Goals. The Quality Policy demonstrates EHNRI’s commitment to quality with clear leadership by management.

Quality Policy Statement Ethiopian Health and Nutrition Research Institute is committed to:

• Continuously improving service with focus on the needs and expectations of clients. • Providing the highest standards of analytical service to clients. • Establishing and maintaining appropriate Quality Objectives and Goals that are relevant and practical. • Ongoing evaluation of the quality of service to its clients, in so far as staff resources and support services

allow. • Open communication with clients to ensure expectations are met. • Ensuring all laboratory personnel are familiar with and implement quality management system policies,

processes and procedures at all time. • Conformity with ISO standards 15189 and 17025, and accreditation requirements.

Quality Goals The quality objectives and goals of EHNRI’s Quality Management System are:

• Quality systems are in place and are documented, communicated, understood and implemented and that the systems are adequately reviewed and audited.

• Personnel are qualified, trained and competent to perform assigned duties. • Processes are validated and subject to adequate quality control and quality assurance assessments. • Equipment, supplies and services are functioning properly and/or meet required specifications. • Required documents and records are maintained. • Facilities are adequate to carry out processing activities.

References

ISO15189-03Medical Laboratories-Particular Requirements for Quality and Competence; 4.2.3:5



TITLE: Director General’s Review of the Quality Management System (QMS)

Revision Date:

Document Number: QP-1.1.2 Status: Draft Section: Quality Management System Page: 1 of 4


Purpose To provide guidelines for reviewing the status, suitability and effectiveness of the Quality Management System..

Policy

The Director General shall evaluate and analyze practices for introducing necessary changes or improvements to the QMS. All documented policies and relevant records shall be reviewed and a list of action plans for improvements will be produced and documented. Copies of the summary information shall be circulated to laboratory directors and staff in keeping with existing policy and procedures. Supporting Statements

Step Action 1. Design and document the process and procedures

The Director General coordinates the review. The process will include: • A list of representatives that will participate • A description of the frequency of the reviews • An outline of what will be reviewed (the inputs) • An outline of how the outputs will be addressed with defined responsibilities • A description of how to monitor the effectiveness of the identified action plans • An outline of the record of the review • A description of how the outcomes will be communicated to staff

2. Prepare a schedule: The Director General’s review of the QMS shall occur at least annually.

3. Define the inputs: The Director General’s review includes, but is not limited to:

• Suitability of policies • Reports from personnel • Outcome of recent internal and external audits • Status of the previous action items • Results of inter-laboratory comparisons and proficiency testing • A review of collected quality indicator data • Feedback, including complaints and other comments from physicians, patients and other

clients • Any changes in the volume and type of work undertaken • Review non-conformances including the status of corrective and preventive actions taken • Evaluation of suppliers


Revision Date:



4. Conduct the review meeting: The meeting follows an agenda in which the minutes become a documented record. All inputs are analyzed to determine if the target has been realized, the action has been adequate or if further improvement can be achieved. An action plan is designed for all identified improvements that defines responsibility for follow-up, timelines for completion and delineates a mechanism to evaluate its effectiveness.

5. Complete follow-up: The Director General will manage the follow-up process to ensure targets are met and the findings are appropriate. Follow-up information is compiled and documented for presentation at subsequent review meetings.

6. Assess the success: All follow-up action plans are assessed to ensure desired outcomes have been achieved. If evidence from these outcomes does not support the quality policy and goals, further action plans are developed with the policy statement and goals revised as appropriate.

7. Maintain the records: Records of the review include but are not limited to:

• The agenda • Minutes attached with provided information files • Action plans with delegated responsibility and defined timelines

8. Communicate the results: A summary report of outcomes is prepared and communicated to all laboratory directors and staff so they can realize the contribution of their data collection is to the betterment of EHNRI. Information may also be shared with relevant clients, patients, physicians and other departments.


Revision Date:



DIRECTOR’S REVIEW OF THE QUALITY SYSTEM Process: The Director shall review EHNRI’s quality management system at planned intervals to ensure its continuing stability, adequacy and effectiveness. The review shall include assessing opportunities for improvements and the need for changes to the quality goals.

o Results of Audits o Customer Feedback & Complaints o QC/PT Results o Status of Preventive Actions and Corrective Actions o Follow up on Action (Previous Meetings) o QMS Changes or Suggestions o Quality Indicators o Suitability of Policies o Reports from Managerial and Supervisory Personnel o Change in Volume and Type of Work Undertaken

o Discuss Agenda Items o Decide on Required Actions o Set Responsibilities o Set Dates for Completion or Monitoring o Changes to the QMS o Monitoring Actions o Improvement of the QMS & Processes o Identify Resource Needs o Communicate/Distribute Report

ATTENDEES: Deputy General Directors Directorate Directors

MEETING (Held annually or as indicated

by the Director General)

MINUTES/ACTIONS (Issued within 3 days of meeting,

maintained by the Director General)

AGENDA (Issued by the Director General)

PROCESS

OUTPUT

INPUT


Revision Date:



Responsibility

Director General ensures that the following happen on a regular basis:

• Review meetings are scheduled and conducted • Meeting agendas are prepared • Data and information supporting agenda items is prepared and collated • Actions to improve the effectiveness of the QMS are identified • Action plan responsibilities are delegated • Timelines for completion of action plans are defined • Progress of action plans is monitored • Policy statement and goals are revised as appropriate • Summary report of outcomes are prepared • Outcomes with appropriate personnel are communicated • Reports on the performance of the QMS including improvements required

are prepared • Review meeting minutes are recorded and maintained

Directorate Director

• Actively participates in the review meeting • Prepares action plans as applicable to their • Completes action plan assignments in a timely fashion • Collects and analyze information and data pertaining to the suitability and

effectiveness of the QMS • Assesses opportunities for improvements to the QMS • Revises policy statement and goals as appropriate • Communicates outcomes to appropriate personnel

Supporting Documents

Document Name Document # Document Location Director General’s Review of the Quality System Form

QP-1.C (Form) Quality Manual

References Fry, C., Crawford, L. Management review – take a good look yourself. QMP-LS News 2008: No125, 1-4. ISO15189-03, Medical laboratories – Particular requirements for quality and competence.


TITLE: Directorate Directors’ Review of the Quality Manual

Revision Date:



Purpose

To provide guidelines for the Laboratory Directors’ review and implementation of the Quality Manual

Policy

A Quality Manual is a document stating EHNRI’s intentions for operating the quality system. It includes quality policies with supporting operating policies for all areas of EHNRI affected by the quality system. These policies authorize the Laboratory Directors to implement processes and procedures within the boundaries specified in the Quality Manual. In order to reflect the current best practices of EHNRI and work towards continuous quality improvement, changes or additions to the Quality Manual are managed by the Laboratory Directors. The Quality Manual shall be reviewed on a regular basis and the review will be documented. These processes shall be coordinated by the Director of the Regional Laboratory Building Capacity Directorates.

Supporting statements

The Quality Manual is used to communicate EHNRI’s expectations for quality and demonstrate compliance with IS) and accreditation requirements The Director General shall review, approve and ensure compliance with the Quality Manual The Quality Manual shall be reviewed, signed and dated annually by the Director General and Directorate Directors.

Responsibility

Director General • Reviews, approves and ensures compliance with the Quality Manual

Directorate Directors • Implements changes to the Quality Manual as determined from the review

• Maintains all record documentation • Reviews the Quality Manual as per existing policy • Forwards the review to the delegated staff for record retention

and implementation of changes to the Quality Manual • Identifies and implements opportunities for improvement

TITLE: Directorate Directors’ Review of the Quality Manual

Revision Date:

Document Number: QP-1.1.3 Status: Section: Quality Management System Page: 2 of 2



Document Name Document # Document Location Quality Policy Statement and Quality Goals QP-1.1.1 Quality Manual Director General’s Review of the Quality System QP-1.1.2 Quality Manual Retention of Records and Diagnostic material OP-4.60 Quality Manual

References

Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007, Section II.C.3 ISO15189-03Medical Laboratories-Particular Requirements for Quality and Competence; 4.12.1:10.



TITLE: Documents and Records Revision Date: Document Number: QP-1.2.1 Status: Draft Section: Quality System Essentials Page: 1 of 3


Purpose

To provide guidance and direction for the processes and procedures used in managing the EHNRI’s documents and records.

Policy

Written policies, processes and procedures are documents that communicate information to those who perform laboratory tasks. EHNRI utilizes a documents and records management system to create, control and maintain laboratory documents and records in accordance with existing administrative policies, regulatory and accreditation requirements. This is managed by establishing responsibility, purpose, content and accessibility, format, standard terminology and retention schedule of all documents and records. Standardized appearance, layout and content of documents and records is used to increase staff understanding and provide consistency throughout the Institute.


Document Creation EHNRI uses a standardized format for creating documents. Document Control EHNRI manages document control by:

Establishing an index of all published documents, identifying current, complete and abridged versions and including their distribution.

Establishing a master file that contains the current version as well as previous versions of all documents.

Having a unique identifier on all documents. Establishing a process to prevent the accidental use of

obsolete documents. Having authorized versions of documents available when

required. Establishing a process for making changes to existing

documents. Document Review and Approval EHNRI follows a process for the review and approval of

documents prior to implementation and distribution, and periodically thereafter.

Document Distribution EHNRI maintains a distribution list of all documents and ensures that personnel identified in this list receive updated documents and return or destroy obsolete documents.

Document Archiving, Storage Documents are archived electronically, stored in a manner that prevents loss, damage or unauthorized access and can be retrieved as required.

Record Retention and Disposal Records are stored for a designated period of time in a location that will allow easy retrieval and will prevent loss or damage.



Retention and disposal of records is defined in the Retention of Documents and Diagnostic Materials Policy.

Record Review and Approval The Directorate Director, or designee, reviews and approves the content of patient records and reports.

Record Change Alterations to records are verified by the person making the change.

Responsibility

Director General • Reviews and approves new or changed quality management policy documents and records

• Reviews and approves management and operational policy

Directorate Director • Develops and implements policies, processes and procedures for document and record management

• Ensures compliance with management and operational policy, process and procedure documents and records

• Ensures compliance with retention times for documents and records

Team Leader • Reviews and approves quality management documents • Develops and implements policies, processes and

procedures for document and record management and records

• Ensures staff compliance with management and operational policy, process and procedure documents and records

• Ensures staff compliance with retention times for documents and records

• Notifies staff of new or changed documents and records Quality Officer • Collaborates with the Regional Laboratory Capacity

Building Directorate to create, review new or changed documents and records, and train staff

• Develop, implement and maintain a Document Control System

• Collaborate with Team Leader to ensure compliance with established policies and procedures.

Laboratory Staff • Create and change documents and records as assigned • Review and use new or changed documents and records



Supporting Documents This policy is supported by the following policies and Processes

Document Name Document # Document Location Documents and Records Management and Numbering of Documents OP-4.1 Quality Manual Quality and Policy document Template OP-4.2 Quality Manual Process template OP-4.3 Quality Manual Technical Procedure (SOP) Template OP-4.4 Quality Manual Form Template OP-4.5 Quality Manual Retention Directives for Laboratory Records and Diagnostic Material OP-4.6 Quality Manual

Guidelines for Citing References OP-4.7 Document Creation, Review, Change and Deletion Request Process OP-4.8 Quality Manual

Use and Printing of Controlled Documents pending Storage, Archiving and Retrieval of Documents pending Document Control Log pending

References Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007 NCCLS. Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition. NCCLS document GP26-A3 (ISBN 1-56238-553-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004. NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.


TITLE: Personnel Policy Revision Date: Document Number: QP-1.2.2 Status: Draft Section: Quality System Essential Page: 1 of 3


Purpose

To provide guidance for the processes to effectively manage the EHNRI’s human resources according to established personnel policies and applicable contractual agreements.

Policy

Employees are a valuable asset to the laboratory. The Human Resource Management and General Service Directorate ensures the hiring of qualified personnel and the provision of well-defined job descriptions. EHNRI thru its HRM directorate provides orientation, training and competency assessment programs including continuing education and staff performance appraisals.

Supporting Statements and Personnel Process

Job Descriptions and Qualifications Job descriptions outlining qualifications, duties and responsibilities are

provided to technical, non-technical and support staff. Orientation EHNRI provides General Orientation to new employees. Training Staff are provided with training in the work processes and procedures

that comprise their respective duties to ensure they are competent to perform them in a quality manner.

Competency Competence of staff is assessed and documented initially after training and periodically thereafter.

Continuing Education Programs for continuing education and professional development are supported and/or provided by EHNRI to ensure personnel maintain, develop and increase their skills.

Performance Appraisals Performance Appraisals are conducted at regular intervals. The Directorate Director develops objectives using the Performance and Development Plan.

Personnel Records The HRM Directorate maintains original copies of confidential personnel records of all employees. The Directorate Directors shall maintain copies of said records

Other Resources Staff collaborates with Human Resources Management Directorate, and other offices such as Safety.

TITLE: Personnel Policy Revision Document Number: QP-1.2.2 Status: Draft Section: Quality System Essentials Page: 2 of 3


Responsibility

Director General • Has the qualifications to assume responsibility • Ensures there are adequate staff resources to perform all

laboratory functions • Approves current job descriptions

Directorate Director • Has the qualifications to assume responsibility • Manages the recruitment and hiring of qualified personnel • Ensures there are adequate staff resources to perform all

laboratory functions • Develops and approves job descriptions • Ensures personnel are trained and competent to perform their

duties and responsibilities • Supports and provides resources for continuing education • Participates in performance appraisal program

Laboratory Team Leader • Have the qualification and required certification to carry out their duties and responsibilities

• Ensures personnel are trained and competent to perform their duties and responsibilities

• Maintains documentation on employee training and competency assessments

• Supports and provides resources for continuing education • Participates in performance appraisal program

Quality Officer • Identifies and prioritizes training needs • Collaborates with the Regional Laboratory Capacity Building

Directorate to ensure timely and effective training is planned, conducted and documented.

• Collaborates with Team Leader to ensure compliance with established policies and procedures.

Laboratory Staff • Have the qualification and required certification to carry out their duties and responsibilities

• Participates in the orientation, training and competency processes

• Participates in continuing education • Participates in performance appraisal program • Maintains external continuing education records

Human Resources Management • Provides general orientation for new employees • Provides personnel policies that are available to employees • Maintains original confidential personnel records • Manages the recruitment and hiring of qualified laboratory

personnel • Offers continuing education opportunities

TITLE: Personnel Policy Revision Document Number: QP-1.2.2 Status: Draft Section: Quality System Essentials Page: 3 of 3



This policy is supported by the following policies and Processes Document Name Document # Document Location Laboratory Orientation OP-3.1 Quality Manual Training and Initial Competency OP-3.2 Quality Manual Competency Assessment Program OP-3.3 Quality Manual Continuing Education OP-3.4 Quality Manual Performance Appraisals OP-3.5 Quality Manual Competency Assessment Documentation Process OP-3.6 Performance Management pending Job Descriptions Director General pending Director of Directorates pending National Quality Officer pending Laboratory Quality Officer pending Team Leader pending Training Specialist pending Laboratory Technician pending Administrative Assistant pending Medical Transcriptionist pending Secretary pending Pathology Assistant pending Booking and Administrative Clerk pending

References

Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007 NCCLS. Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition. NCCLS document GP26-A3 (ISBN 1-56238-553-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004. NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.



TITLE: Equipment, Reagents, and Supplies Revision Date: Document Number : QP-1.2.3 Status: Draft Section: Quality System Essential Page: 1 of 3


Purpose

To provide guidance and direction for the processes and procedures related to the receiving, management and disposal of laboratory equipment, reagents and supplies.

Policy

EHNRI will ensure that all laboratory equipment, reagents and supplies are installed, calibrated, maintained and used in accordance with the manufacturer’s instructions, as well as all additional accreditation and regulatory requirements. EHNRI will have consistent processes for installing, calibrating, operating, maintaining, and troubleshooting equipment, as well as for obtaining service when needed. Supporting Statements and Equipment Process

Selection and Acquisition The Laboratory Directorates in collaboration with the Directorate of

Planning and Finance will establish a mechanism to determine criteria and methods for the selection and acquisition of new equipment, reagents and supplies.

Installation EHNRI will establish criteria and methods for equipment installation. Identification EHNRI will establish a means to uniquely identify each piece of

laboratory equipment. Validation EHNRI will develop a validation mechanism prior to implementation

of equipment to ensure that it performs as intended and periodically thereafter as required.

Calibr ation Program EHNRI will develop a means to establish a program for the calibration and due date for laboratory equipment.

Operation EHNRI will ensure that Standard Operating Procedures (SOP) for laboratory equipment are established, implemented, maintained and regularly updated according to regulatory guidelines and standards.

Maintenance Program

EHNRI will ensure that SOPs and logs for equipment maintenance are established, implemented, maintained and regularly updated according to regulatory guidelines and standards.

Troubleshooting, Service and Repair EHNRI will develop a process to remove defective (or suspected to be defective) equipment from service, and also a process to verify proper equipment performance before returning it to service. Troubleshooting guidelines and records shall be established and maintained.

Decommissioning and Disposal

EHNRI will develop criteria and a process for retiring and disposing of outmoded or obsolete equipment.

Equipment Files and Records

EHNRI will maintain records of history related to the life and decommissioning for each piece of equipment.

TITLE: Equipment, Reagents and Supplies Revision Date: Document Number : QP-1.2.3 Status: Draft Section: Quality System Essential Page: 2 of 3


Responsibility

Director General Ensure adequate resources are available to fulfill laboratory needs for equipment, reagents and supplies

Directorate Director 1. Ensure there is a program established for the management of equipment, reagents and supplies.

2. Collaborates with Directorate of Planning and Finance in the acquisition of equipment, reagents and supplies

3. Collaborate with the Regional Laboratory Capacity Building Directorate on the validation process

4. Review and approve validation protocols. 5. Ensures the validation process is performed.

Quality Officer and Team Leader 1. Identify needs for equipment, reagents and supplies. 2. Develops validation protocols 3. Ensures implementation of validation process 4. Collaborate with Director and Team Leader to ensure

compliance with established policies and procedures. Laboratory Staff 1. Participates in the validation process.

2. Participates in the maintaining of equipment, reagents and supplies.


This policy is supported by the following documents: Document Name Document # Document Location Balance Calibration OP-5.1 Quality Manual Pipette Calibration OP-5.2 Quality Manual Reagent Water Quality OP-5.3 Quality Manual Temperature and Humidity Monitoring and Alarm Program

OP-5.4 Quality Manual

Handling, Storage and Transport of Equipment, Reagents and Supplies


Medical Device and Product Alerts OP-5.6 Quality Manual Centrifuge Management Program OP-5.7 Quality Manual Equipment Records and Logs pending Equipment Management pending Control of Inventory Purchasing, Receipt, Storage and Validation of Reagents and Supplies

pending

Inventory Receipt, Reconciliation, and Storage Form

pending

Inventory Control Process pending Equipment Management Program pending

References

TITLE: Equipment, Reagents and Supplies Revision Date: Document Number : QP-1.2.3 Status: Draft Section: Quality System Essential Page: 3 of 3





TITLE: Purchasing and Inventory Revision Date: Document Number: QP-1.2.4 Status: Draft Section: Quality System Essential Page: 1 of 2

NOTE: This is a CONTROLLED document for internal use only

Purpose

To provide guidance and direction for the processes and procedures related to purchasing and inventory control of laboratory reagents, supplies and services.

Policy

Effective inventory control is expected to increase efficiency by providing an uninterrupted flow of materials needed to operate the laboratory. Laboratory Directorates in collaboration with the Directorate of Planning and Finance will identify the supplies and services used and define the criteria to be met by the vendors for each supply and service. EHNRI shall ensure processes are established for receiving, inspecting and testing (where necessary) purchased materials and for managing inventory.

Supporting Statements and Purchasing and Inventory Process

Identification of Materials and Services

EHNRI identifies materials and services needed to operate the laboratory and develops a system for their validation, control and management.

Vendor Qualification EHNRI establishes a system to evaluate and select vendors of equipment, supplies and services.

Purchase Agreements and Review EHNRI has a system to define, document, periodically review and make changes to purchase agreements.

Inspection and Testing of Received Materials

EHNRI has a system to receive, inspect (and test where needed), accept, store and inventory incoming materials.

Storage and Handling of Materials EHNRI has a system of handling and storage of reagents and supplies to monitor expiry dates, product condition and acceptability upon receipt, and ensures all products are manually labeled with receipt-date upon entering them into inventory.

Product Changes by Manufacturer EHNRI has a process ensuring product notifications from manufacturers are identified and handled appropriately and in a timely manner.

Inventory Management EHNRI ensures there is an inventory control process that addresses appropriate inventory levels, such as minimum inventory and safety stock requirements, inventory rotation to ensure the oldest stock is used before the newest, and stock levels that trigger re-order. This process includes a written record of inventory levels and usage.

Vendor Evaluation EHNRI has a mechanism for vendor evaluation and feedback.

TITLE: Purchasing and Inventory Revision Date: Document Number: QP-1.2.4 Status: Draft Section: Quality System Essential Page: 2 of 2


Responsibility Director General • Ensure adequate resources are available to maintain supplies

and equipment service. • Ensure a purchasing and inventory control process is

established for EHNRI Directorate Director and Team Leader • Identify services and supplies needed to operate the directorate

laboratories. • Collaborate with the Planning and Finance Directorate to

evaluate and select appropriate vendors of equipment, supplies and services.

• Collaborate with RLCBD in order to implement policies, processes and procedures for purchasing, receipt, and management of inventory in the laboratory.

• Collaborate with Planning and Finance Directorate in the documentation and periodic review of, and changes to, purchase agreements.

Quality Officer • Collaborate with Director and Team Leader to ensure compliance with established policies and procedures.

Laboratory Staff • Ensures fiscally responsible use of reagents and supplies. • Monitors inventory and reports to appropriate person when

inventory levels need to be adjusted.


This policy is supported by the following documents: Document Name Document # Document Location Purchasing Policies pending Purchasing of Supplies pending

References

National Committee for Clinical Laboratory Standards. Inventory Control Systems for Laboratory Supplies; Approved Guideline. NCCLS document GP6-A (ISBN 1-56238-228-4). NCCLS, 771 East Lancaster Avenue, Villanova, Pennsylvania 19085, 1994.


TITLE: Process Control Revision Date: Document Number: QP-1.2.5 Status: Draft Section: Quality System Essential Page: 1 of 4


Purpose

To provide guidance and direction for the effective management of process control.

Policy EHNRI ensures that all laboratories establish, adhere to, and continually review detailed, clearly written procedures for all elements of its pre-analytical, analytical, and post-analytical processes. This ensures that consistent, productive and efficient operations will meet the needs of our patients and clients, and that the Institute will comply with regulatory body requirements. Supporting Statements and Process Control Laboratory Practice EHNRI Laboratories conduct operations in accordance with current

laboratory practice as applicable: Good Laboratory Practice (cGLP), Good Clinical Laboratory Practice (cGCLP), Good Clinical Practice (cGCP), Good Manufacturing Practice (cGMP)

Specimen Collection Manual EHNRI provides a Specimen Collection Manual to all appropriate specimen collection facilities.

Technical Procedures EHNRI ensures that well written technical procedures (SOPs) are available in the document control system, as well as in all work areas, to ensure consistency in performance. Technical procedure manuals are reviewed by appropriate personnel.

Reference Ranges Reference ranges are established or validated for each test performed in the EHNRI. Review of reference ranges occur as required.

Validation of Methods and Procedures

Validated methods are used to confirm that processes and procedures meet established criteria for performance.

Quality Control & Intra/Inter Laboratory Comparisons

EHNRI develops and implements a quality control program. The program ensures comparability of results across all sites (inter), as well as comparability of results on analyzers at the same site (intra).

External Proficiency Testing EHNRI participates in programs of external proficiency testing to verify that the intended quality of results is achieved.

Critical Values EHNRI establishes critical values for examination results that are life threatening, and has a process to ensure that critical results are communicated in a timely manner.

Turn Around Times EHNRI establishes turnaround times for each test as appropriate. Retention of Specimens & Reported Results

Specimens and reported results are retained as per Retention of Documents and Diagnostic Material Policy.

Communicable and Reportable Diseases

EHNRI complies with legislated requirements for reporting communicable and reportable diseases

Resolution of Discrepant Results EHNRI has a process to deal with discrepant results. Corrected Reports EHNRI documents alterations to records or results with the date, time and

the individual who made the changes.



Responsibility

Director General

• Reviews and approves quality policies and ensures implementation of and compliance with said policies

Directorate Director and Team Leaders

• Ensure the development and implementation of a quality control program, and define acceptance/rejection criteria.

• Assess, justify, add or remove tests to/from the laboratory’s test menu • Ensure that all procedures are validated to confirm that they are suitable

for their intended use and that they work as expected. • Review and approve technical policies, processes and procedures • Establish and periodically review reference ranges. • Participate in accreditation • Maintain an updated specimen collection manual • Ensure that written standard operating procedures (SOP) for all steps in the

path of workflow are available to appropriate staff. • Assist with the establishment of turnaround times for each examination • Review internal and external quality assessment results and the corrective

action taken as a result of the root cause analysis Quality Officer • Collaborate with Director and Team Leader to ensure compliance with

established policies and procedures. • Collaborate with RLCBD to ensure compliance with laboratory regulations

and standards. Laboratory Staff • Adhere to the EHNRI policies, processes and procedures

• Performs QC, reviews and reports QC and takes corrective action when required

• Participates in the validation process • Participates in accreditation activities as assigned




Document Name Document # Document Location Documents and Records Retention of Records and Diagnostic Material OP-4.6 Quality Manual Pre-Analytical Laboratory Path of workflow OP-6.1.1 Quality Manual Specimen Acceptance and Rejection OP-6.1.2 Quality Manual Specimen Label requirements OP-6.1.3 Quality Manual Process for Mislabeled/Unlabeled Specimens OP-6.1.4 Quality Manual Laboratory Test Utilization OP-6.1.5 Quality Manual Specimen Acceptance, Cancellation and Canned Text comments pending

Requisition, Verbal and Add-On Tests pending Specimen Collection pending List of Examination Procedures pending Implementation Of a New Test pending New Test Implementation Form pending Transportation of Dangerous Goods pending Transport of Specimens pending Analytical Technical Procedures (SOPs) OP-6.2.1 Quality Manual Method Validation Guidelines OP-6.2.2 Quality Manual Reference Ranges – General OP-6.2.3 Quality Manual Review of Technical Procedure Manuals pending STAT Lists pending Job Aid Guidelines pending Post-Analytical Critical Results Reporting OP-6.3.1 Quality Manual Critical Values OP-6.3.2 Quality Manual Discrepant Results OP-6.3.3 Quality Manual Final Report OP-6.3.4 Quality Manual Results Management pending Release of Laboratory Report pending Communicable and Reportable Diseases pending Release of Specimens for Legal Purpose pending



References



NoYes

PHASE lInventory Planning

PHASE llSystems Development

PHASE lllProcurement

PHASE lVManagement

ItemIdentification

Product Demographics

Frequencyof Evaluation

ModeratePriority

HighPriority

Low Priority

Lab SectionItem Lists

StorageInventoryRequisition

Start

Start

WorkingInventory

Supply Network

• Purchasing• Receiving• Accounts Payable• Suppliers

Stores

• Central• Sectional• Refrigerated• Special

Supplies AnalysisIdentification/Classification

MeasuringInventory

Controlling Inventory

Receipt

SupplyOrdering

ControllingInventory

Supplies AnalysisForms

InventoryControlCards

Master SupplyLists

YesNo


TITLE: Information Management Revision Date: Document Number: QP-1.2.6 Status: Draft Section: Quality System Essential Page: 1 of 3


Purpose To provide ease of access and dissemination of accurate and reliable laboratory test results and interpretations to customers in a timely and secure manner.

Policy Patient information is private and confidential. EHNRI employs Information Technology Services to ensure security for data access, integrity of data transmission and provision for information availability during downtime.

Supporting Statements

Paper-based records EHNRI maintains manual Information Management Systems in

compliance with laboratory standards, when electronic records are not available and as back-up to computer LIS systems.

Confidentiality EHNRI establishes systems to ensure confidentiality of all patient records both manual and electronic.

Computer Environment EHNRI provides a clean and well-maintained environment for the operation of computers and computerized equipment that complies with vendor specifications.

Computer Access & Security Processes are in place to prevent unauthorized access to patient information in the LIS and laboratory instruments.

Data Entry and Reporting Mechanisms are in place to identify individuals who enter, verify and release patient information.

Data Retrieval and Storage Archived patient results are able to be retrieved within a time frame consistent with patient care needs. Back-up data storage media are properly labeled and stored within both the IT unit at EHNRI and an offsite storage facility.

Data Integrity Data integrity is verified by comparing patient information on reports with original requisition and input. Periodic reviews and verification of auto-verification processes by LIS and laboratories are conducted and documented.

Requests for Information Established processes and procedures are in place for the handling of requests for patient information/test results.

Computer Downtime Downtime procedures are in place to ensure the availability of patient test results during hardware or software failure.

Change Approval The IT Unit Chief or designate approves all significant changes in LIS. Computer Procedures Policies, procedures and processes are in place for change control,

training, and downtime. Computer Validation The laboratories ensure computer programs and/or changes are

validated prior to implementation. Records of the validation process and the results are maintained in the IT Unit of the Institute.

TITLE: Information Management Revision Date: Document Number: QP-1.2.6 Status: Draft Section: Quality System Essentials Page: 2 of 3


Computer System Maintenance System maintenance and back-up is performed by the IT Unit on a regularly scheduled basis.

Responsibility

Director General • Reviews and approves all computer and LIS policies that may affect patient care.

• Ensures adequate resources are readily available. Directorate Director and Team Leader • Ensure appropriate automated systems and processes are in

place to provide health care providers with accurate and timely information to manage patient care.

• Ensures staff compliance with all computer and LIS policies and procedures.

• Work with both the IT Unit and Laboratory Informatics Group (LIG) to ensure all tests are built appropriately in order to report results, interpretations, and reference ranges.

Laboratory Informatics Group (LIG)

• Collaborates with IT Unit to maintain the Laboratory Information System.

• Validates and verifies new software for LIS. • Builds and/or makes changes to LIS procedures and

documents same. • Provides training when new processes and/or procedures are

implemented in LIS. • Develops policies for implementation of a LIS system

Quality Officer • Collaborates with Director and Team Leader to ensure compliance with established policies and procedures.

• Collaborates with RLCBD to ensure compliance with laboratory standards.

Laboratory Staff • Follows established policies, procedures, and processes for entering, verifying and releasing patient information/results in LIS

• Notifies appropriate individuals when computer problems are identified.

Information Technology Unit • Maintains and performs back-up procedures for the LIS on a regularly scheduled basis.

• Collaborates with the LIG • Initiates fan-out when the LIS requires shutdown or restarting.

TITLE: Information Management Revision Date: Document Number: QP-1.2.6 Status: Draft Section: Quality System Essentials Page: 3 of 3



Document Name Document # Document Location Safety & Facilities QP- 1.2.11 Quality Manual LIS Manual (includes Downtime Procedures) pending LIS Downtime Notification/Fan -Out pending

References




TITLE: Occurrence Management Revision Date: Document Number: QP-1.2.7 Status: Draft Section: Quality System Essential Page: 1 of 3


Purpose

To provide guidance for the laboratory to effectively manage occurrences that may place patients at risk.

Policy

EHNRI identifies, investigates and reports adverse events in accordance with the Patient Safety Reporting. EHNRI classifies, analyzes and trends information from non-conformance events and complaints and identifies the need for root cause analysis and opportunities for process improvement. Definitions Adverse event: An unexpected and undesired incident directly associated with the care or services provided to

the patient that does, or can be reasonably expected to, negatively affect the patent’s physical and/or psychological health and/or quality of health

Non-conformance or occurrence: Something that happens that does not conform to established policies, processes or procedures

Root cause: The basic cause or contributing other factors at the root of the event; a root cause analysis focuses on systems and processes

Supporting Statements and Occurrence Processes

Identification and Reporting

Staff recognize adverse and nonconforming events and initiates reports. Adverse events and laboratory non-conformances (NCE) are documented and reported to the team leader.

Remedial Action The person who identifies an adverse or non-conformance event takes immediate action to rectify the problem and documents action taken

Corrective Action Action is taken to eliminate the root cause of a detected non-conformance Preventive Action Action is taken to eliminate the cause of a potential non-conformance Investigating and Documenting

EHNRI investigates adverse and non-conformance events and assigns staff to take corrective action when required to eliminate the root cause.

Classifying All events are classified into adverse or non-conformance events according to level of severity of harm to patient and work processes involved.

Analysis and Data Presentation

EHNRI analyzes the data from Patient Safety Reports and NCE for trends and patterns.

Directorate review and referral to Process improvement

The Directorate Directors reviews and prioritizes information for follow-up that may include resource allocation or process improvement initiatives.

Complaint resolution EHNRI has processes to resolve written and verbal complaints and respond to feedback from clients.

Just culture EHNRI supports a just culture where staff is willing to report adverse events and nonconformities without fear of punishment.


NOTE: This is a CONTROLLED document for internal use only. .

Responsibility

Director General

• Ensures implementation of and compliance with policies and supporting documents

• Ensures adequate staff resources are available to perform all laboratory functions

Directorate Director • Ensures that all non-conforming events are investigated, documented,

corrected and reported • Assesses all patient safety reports and reports to Director General

Team Leaders

• Determines root cause of occurrences • Prepares statistical or summary reports and forwards to appropriate

groups for review and improvement • Implements and monitors improvements to processes and procedures

Quality Officer

• Ensures that all non-conforming events are investigated, documented, corrected and reported

• Determine root cause of occurrences • Maintains records of all non-conformance events for the purpose of

tracking • Prepare statistical or summary reports and forwards to appropriate groups

for review and improvement • Collaborates with RLCBD to monitor and evaluate occurrence

management data, root cause analysis and corrective actions.

Laboratory Staff

• Know and follow policies and procedures • Document and report adverse events and non-conformances according to

established policies and procedures. • Identify, classify, initiate corrective action.


NOTE: This is a CONTROLLED document for internal use only. .


Document Name Document # Document Location Nonconforming Laboratory Events OP-8.2.1 Quality Manual Laboratory Nonconforming Event Process Table pending Laboratory Nonconforming Event Report Form pending Laboratory Nonconforming Event Training Form pending

References

Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007, Section II.D.5-6

CAN/CSA-Z15189-03 Medical Laboratories – Particular Requirements for Quality and Competence; 4.8-4.9 Clinical and Laboratory Standards Institute (CLSI). Management of Nonconforming Laboratory Events; Proposed Guideline. CLSI document GP32-P



TITLE: Assessments - Internal / External Revision Date: Document Number: QP-1.2.8 Status: Draft Section: Quality System Essential Page: 1 of 3


Purpose

EHNRI’s assessment activities are conducted to identify how well laboratories are performing, and to ensure compliance with requirements.

Policy

The quality activities shall be identified, measured and monitored for all major processes in laboratory operations. Action shall be taken when the information from audits, quality indicators or external assessments demonstrates unacceptable performance. Periodic audits of operation and the quality management system (QMS) can demonstrate discrepancies between laboratory documents and actual operating procedures.


Internal Audits • QMS audits are periodically performed under the direction from the Director, and chaired by an individual outside the laboratory, to ensure operations continue to comply with QMS.

• The audit assesses compliance with internal policies, processes and procedures as well as any applicable regulations and requirements.

Quality Indicators • Quality indicators are established for pre-analytical, analytical, and post-analytical activities with measurable outcomes.

• Quality indicators are monitored on an ongoing basis to evaluate the department’s performance and improvements of service offered.

• The findings are documented and reported. • Action is taken on indicators that demonstrate unacceptable

performance. External Assessment

• EHNRI Laboratories participate in external assessment programs, appropriate for the lab specialty (Proficiency Testing, PT).

• Laboratories review and evaluate results and initiate corrective action when observed results do not meet program acceptability criteria.

• Results are reported per program requirements; to the Laboratory Management; to RLCBD; and to EHNRI Senior Management.



Responsibility

Director General • Reviews and approves internal audit policies • Ensures there are adequate staff resources to perform internal audits

Directorate Director • Develops and implements quality indicators • Ensures quality indicators are monitored, documented, reported and actions

taken as required • Ensure that management audits are regularly conducted • Reviews and follows up on action plans related to QMS audits • Initiate audits with Team Leaders on a regular basis

Team Leaders

• Establishes and trains audit teams • Reviews and follows up on action plans related to QMS audits • Develops and implements quality indicators

Quality Officer • Collaborates with the RLCBD to manage the internal assessment program Laboratory Staff • Participate in the measurement of the quality indicators

• Participate in audits of the QMS Supporting Documents

Document Name Document # Document Location Process to Manage EQA Quality Manual Quality Indicators pending Internal Quality Audits pending Corrective and Preventive Actions pending Root Cause Analysis Flowchart pending Root Cause Analysis Template pending

References

NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.




TITLE: Process Improvement Revision Date: Document Number: QP-1.2.9 Status: Draft Section: Quality System Essential Page: 1 of 3


Purpose

To provide guidance for the laboratory to assess and improve the quality of laboratory services provided.

Policy

EHNRI identifies opportunities for preventing problems through process improvement and monitoring of outcomes of patient care. EHNRI pursues continuous quality improvement (CQI) by using the five quality components, Quality Planning (QP), Teamwork (QT), Monitoring (QM), Improvement (QI) and Review (QR). EHNRI uses an established improvement process to take corrective action for recognized process problems, review all processes to identify potential sources of non-conformances for preventive action and evaluates the effectiveness of improvement actions taken.

Supporting Statements and Improvement Processes

Quality Planning EHNRI has processes that anticipates and identifies problems and plans strategies, goals, objectives and tasks through a review of current and foreseeable customer needs.

Quality Teamwork

EHNRI exercises leadership, empowerment, cooperation, and analytical skills through effective, team-based decision making. EHNRI has standards of expected performance for team-based quality decision making, quality team training and assesses team capabilities and skills.

Quality Monitoring EHNRI has processes for ongoing monitoring of pre-analytical, analytical and post-analytical activities to meet customer satisfaction, based on measurable quality indicators that characterize the most important processes on a prioritized, cost-effective basis.

Quality Improvement

EHNRI identifies and resolves current problems in processes as evidenced by quality indicator surveillance data that exceed their predetermined thresholds (corrective action); and identifies and improves processes that require improvement to satisfy a prioritized customer need (preventive action).

Quality Review EHNRI has a process to assess corrective and preventive actions by reviewing quality reports, opportunities for improvement and improvements in outcomes.



Responsibility

Director General

• Ensures availability of adequate staff resources to perform all laboratory functions

• Reviews the Quality Management System implementation on a regular basis

• Ensures the Implementation of and compliance with the twelve quality system essentials (QSE)

• Facilitates systematic improvement through the sequential exercising of the five quality components (QP, QT, QM, QI, QR)

• Reviews the Quality Manual on a periodic basis


• Implements and sustains continuous process improvement • Ensure staff have sufficient education, training, resources, time and

empowerment to achieve CQI • Practice quality assurance (QA) by measuring effectiveness of processes

through selection and monitoring of indicators • Approve process improvement actions developed and provide resources

for implementing actions • Prepares annual quality report for laboratory by QSE and submits to

Director General • Prepares annual report documenting activities and outcomes and submits

to Director General • Establishes an internal audit program, an external peer assessment

program and an external benchmarking program • Identifies, measures and controls the cost of quality

Team Leaders and Quality Officers

• Develops and reviews ENRI’s mission, vision and strategic planning in relation to customer needs and satisfaction

• Performs specific operational functions either routinely or ad hoc depending on the extent and nature of the problem or opportunity.

• Designs, trains and maintains a team- skills training curriculum and schedule

• Prepares a Quality Report documenting status of action plans • Uses the Quality Report to identify opportunities for process

improvement and to prioritize the processes needing improvement • Collaborate with RLCBD to select appropriate improvement process and

action plan necessary to resolve the problem • Implements the action plan • Measure and report the quality outcome • Provides guidance and recommends resources to solve highlighted

problems • Provides input to their Directorate Director

Laboratory Staff

• Know and follow quality control (QC) policies and procedures • Understand teamwork essentials such as structure, behaviour and

opportunity finding and analytical problem-solving skills • Take active role in the CQI process, use initiative and work with others to

anticipate and solve quality process problems




Document Name Document # Document Location Continuous Quality Improvement OP-8.1.1 Quality Manual Continuous Quality Improvement Process OP-8.1.2 Quality Manual Quality Improvement Plan Template OP-8.1.3 Quality Manual Nonconforming Laboratory Events OP-8.2.1 Quality Manual Director’s Review of the Quality System QP-1.2 Quality Manual Director’s Review of the Quality Manual QP-1.3 Quality Manual Laboratory Nonconforming Event Process Table pending Laboratory Nonconforming Event Report Form pending Laboratory Nonconforming Event Training Form pending

References

Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007, Section II.D.7 15189-03 Medical Laboratories – Particular Requirements for Quality and Competence; 4.10-4.12 Clinical and Laboratory Standards Institute (CLSI). Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline-Second Edition. CLSI document GP22-A2


TITLE: Client Service And Satisfaction Revision Date: Document Number: QP-1.2.10 Status: Draft Section: Quality System Essential Page: 1 of 2


Purpose

To ensure the satisfaction of various client groups with EHNRI’s services.

Policy

EHNRI shall actively seek and measure the satisfaction of its internal (including staff) and external clients. EHNRI’s operational processes and procedures shall align with the respective needs of these clients. When feedback, from a survey or through a complaint, indicates the need for improvement, actions are taken to improve the service. Supporting statements Client complaints

EHNRI receives and responds to complaints

Satisfaction surveys EHNRI conducts satisfaction surveys with internal and external clients on a regular basis, including staff.

Monitoring EHNRI monitors trends related to compliments and complaints from clients

Responsibility

Director General • Establishes excellent relationships with both internal and external clients • Ensures processes to measure client satisfaction levels related to laboratory

service are implemented Directorate Director and Team Leader

• Identifies opportunities for process improvement • Ensures documentation and management of complaints • Ensures client satisfaction surveys are conducted on a regular basis • Analyses and documents survey results • Undertakes improvement actions as indicated from survey results • Ensures staff have the necessary skills to provide excellent client service

Quality Officer • Collaborate with Director, Team Leader and RCLBD to monitor, evaluate and address customer needs and level of satisfaction..

Laboratory Staff • Ensures documentation and management of complaints • Participates in the client satisfaction surveys as both a client and facilitator to

other clients • Participates in improvement actions • Provides excellent customer service to internal and external clients

TITLE: Client Service and Satisfaction Revision Date: Document Number: QP-1.2.10 Status: Draft Section: Quality System Essential Page: 2 of 2



Document Name Document # Document Location Service and Satisfaction Survey pending Customer Complaint Process pending Customer Service Complaint Form pending

References

Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007 NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.


TITLE: Safety and Facilities Revision Date: Document Number: QP-1.2.11 Status: Draft Section: Quality System Essential Page: 1 of 4


Purpose To provide a laboratory work environment for staff that ensures safe work practices, promotes personal wellness, and safety to the patients and environment. The laboratory’s physical facilities are constructed and maintained to support its activities. Policy Safety in the workplace is vital to keeping employees healthy and able to continue working. The Institute collaborates with various institutions including Fire and Safety, Infection Control, and Maintenance Services, and ensures compliance with Occupational Health and Safety Regulations. The Institute also ensures the design and location of its physical facilities are appropriate to support quality work, safety of personnel, patient and environment.

Supporting Statements

Safety Officer The Safety Officer supports laboratory management on issues

concerning safety. A safety officer is designated for each laboratory. Safety Committee The Laboratory Services Safety Team (LSST), with representation

from all laboratories, meets on a regular basis to address safety concerns throughout the Institute.

Safety Manual A safety manual, specific to the Institute is available to all staff. Safety Procedures Safety procedures appropriate to the work environment are written and

enforced. Safety Audit A safety audit is conducted annually by LSST. Safety Inspections Members of the LSST conduct safety inspections at the Institute on a

regular basis. Safety Records Results of inspections, audits and corrective actions are documented

and communicated to EHNRI Management. Hazards Identification Hazardous areas are clearly identified through signage, or by labeling

in the case of biological or chemical hazards. Reporting of Incidents/Accidents Incidents/ accidents are reported to the immediate supervisor. A

Workplace Incident Form is completed and given to the laboratory/site safety officer for remedial action as required.

Safety Training Safety training is an integral part of orientation for new staff. Refresher and/or remedial training is provided to staff as needed or as required by regulation.

Personnel Responsibilities Staff is responsible for consistent implementation of appropriate infection control procedures when working with patient samples. Staff works in accordance with established safety policy, processes and

TITLE: Safety & Facilities Policy Revision Date: Document Number: QP-1.2.11 Status: Draft Section: Quality System Essential Page: 2 of 4


procedures, as defined in the Laboratory Safety Manual and other manuals where applicable.

Protective Equipment The Institute provides personal protective equipment (PPE) of proper fit (e.g. lab coats, gowns, gloves, goggles, masks, safety glasses, face shields) to staff and visitors as needed for safety protection.

First Aid and Emergency EHNRI ensures that first aid and emergency practices are in compliance with the requirements of available national regulations. Emergency first aid is available 24/7.

Dangerous Materials Storage and disposal of dangerous materials are in accord with relevant regulations and safety lab practices.

Chemical Safety Chemicals used in the Laboratory are labeled, stored, handled and disposed of in compliance with safety regulations and generally accepted safe laboratory practice.

Visitors Visitors to the Laboratory are made aware of hazards they may encounter.

Electrical Safety In conjunction with Safety Inspections, electrical cords are checked for damage and portable equipment checked for grounding. Adequate and dependable (uninterrupted power) is available to provide for all laboratory equipment.

Fire Safety Fire exits are clearly identified and kept clear. Fire alarms, appropriate portable extinguishers and flammable spill kits are maintained in good working order and available to staff for use. Flammable liquids are stored in limited amounts in appropriate containers in compliance with relevant regulations.

Location & Design The location and design of the laboratory supports the tasks carried out and optimizes workflow to ensure a safe and efficient workplace.

Environmental Conditions Environmental conditions are monitored and recorded to ensure test results and automated equipment are not affected. Ambient temperature and humidity are controlled within limits required by laboratory instrumentations and methods.

Access There is no unauthorized access to the laboratory. Hazardous areas or areas having a controlled environment are regulated. There is also effective separation between laboratory sections that perform incompatible activities.

Storage Separate storage areas and conditions are adequate for samples, equipment, reagents, supplies, documents and records.

Computer Environment The Institute provides a clean and well-maintained environment for computer equipment that complies with vendor specifications.



Responsibility

Director General • Ensure laboratory safety policies are implemented and enforced • Ensures availability of adequate resources to perform all laboratory safety

functions Directorate Director & Team Leader

• Ensures safety manuals and training are available to staff. • Ensures compliance with safety policies and procedures. • Maintains an inventory of hazardous materials present in the workplace

along with current Material Safety Data Sheets (MSDS). • Review accident/incident reports to ensure corrective/preventive action is

taken. • Ensures a sufficient number of employees are certified in the Transport of

Dangerous Goods (TDG) when transporting or preparing for transport biological material and dangerous goods.

• Ensures the location, design and environmental conditions conform to EHNRI policies and regulatory requirements.

Quality Officer • Collaborate with Director, Team Leader and Safety Officer to ensure all regulations, policies and procedures are enforce.

• Collaborates with RLCBD to ensure compliance with laboratory standards. Laboratory Staff

• Participate in safety orientation and training as required. • Use appropriate PPE as necessary. • Read the Safety Manual and comply with safety policies. • Use safe work practices and other safety processes to ensure the protection

of themselves, coworkers, patients and the public from exposure to sources of danger.

• Participates in audits and inspections as required. Safety Officers

• Report safety deficiencies to supervisor or manager. • Provide safety orientation and training to staff. • Review Workplace Incident Reports. • Perform safety audits and inspections.

LSST

• Ensures all laboratories undergo safety audits and inspections annually. • Acts as a resource to mediate controversial safety issues. • Review and maintains the Safety Manual • Performs audits and inspections as required.

Engineering/Maintenance Services

• Collaborates with the laboratory to plan for new or renovated facilities. Maintains facility services for ventilation, electrical, plumbing, painting, and carpentry.




This policy is supported by the following policies: Document Name Document # Document Location Laboratory Safety Manual pending Fire Safety Program pending Workplace Hazard Identification & Safety Inspections & Compliance

pending

Personal Protective Equipment pending MSDS pending Safety Checklists pending Workplace Incident Form pending Maintenance request form pending

References


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TITLE: Department Organizational Structure Revision Date: Document Number: OP-2.1 Status: Draft Section: Organization Page: 1 of 2


Purpose To define the organizational and management structure of EHNRI Policy The laboratory is a complex and challenging workplace which requires expertise in organization, management and communication to direct it successfully. EHNRI shall establish accountability by developing an organizational structure that allows efficient operation of the laboratory. Supporting statements Organizational Chart • EHNRI describes its administrative structure through an organizational

chart (OP-2.0) • The organizational chart provides a blueprint for laboratory action and

communication by clarifying areas of authority and responsibility. • Each laboratory develops an organizational chart following established

lines of authority and responsibility that are specific for their laboratory area.

• The organizational structure is kept current by making personnel changes to the charts as needed.

Responsibility Director General Reviews and approves policy

Directorate Director Develops organizational charts specific to areas of responsibility Updates laboratory’s organization chart for the Quality Manual

References CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 5.1.1:12.



TITLE: Operational Committees Revision Date: Document Number: OP-2.2 Status: Current Section: Organization Page: 1 of 2


Purpose

To provide guidelines for the establishment and operation of committees.

Policy

EHNRI shall have Operational Committees that provide leadership, planning and direction to achieve and maintain the highest quality of laboratory services.

Supporting statements Operational Committees EHNRI maintains Operational Committees to support the

management and administrative functions of the EHNRI and include:

a. Senior Management Committee b. Tender and Procurement Committee c. Discipline Committee d. Employment Committee e. Safety Committee f. Quality Task Force g. National Laboratory Accreditation Steering Committee

Ad hoc Committees Ad hoc committees or sub-committees are created when

necessary to investigate quality improvement initiatives or other projects. These committees are usually short-term and disbanded when the project is completed.

Authorization The Director General or Deputy and the Directorate Directors

can authorize the establishment or discontinuance of all Operational Committees.

Terms of Reference All committees establish Terms of Reference that include purpose, membership and meeting procedures.

Confidentiality All committee members respect confidentiality by keeping discussions confidential unless otherwise agreed.

Decision Making Committee decisions are reached through consensus after fair and open discussions.

Conflict of Interest Committee members are expected to disclaim any potential conflict of interest and, if necessary, excuse themselves from the meeting until the discussion is over.

Meeting Minutes Minutes reflecting attendance, subjects discussed and actions to be taken are kept at all meetings.

Annual Report Each Operating Committee prepares an annual report containing a summary of activities.

TITLE: Operational Committees Revision Date:

Document Number: OP-2.2 Status: Current Section: Organization Page: 2 of 2



Document Name Document # Document Location Senior Management Committee pending Tender and Procurement Committee pending Discipline Committee pending Employment Committee pending Safety Committee pending Quality Task Force pending National Laboratory Accreditation Steering Committee

pending

References

CAN/CSA-Z15189-03Medical Laboratories-Particular Requirements for Quality and Competence; 5.1.4



TITLE: Orientation Program Revision Date: Document Number: OP-3.1 Status: Draft Section: Personnel Page: 1 of 2


Purpose

To acquaint new staff with a personal and physical introduction to the laboratory and facility environment.

Policy

EHNRI’s Orientation Program is designed to welcome new individuals to the laboratory and facility, to introduce them to the culture, mission, vision and values of the laboratory and to communicate pertinent information. Definitions New Staff: employees new to a laboratory (for the purposes of this document, this includes medical staff, as well

as technical and administrative staff)

Supporting statements EHNRI General Orientation New staff shall receive General Orientation to EHNRI Staff Transfer Staff transferring to a new laboratory shall participate in the

orientation process for that laboratory Laboratory Orientation Each laboratory shall establish orientation procedures; provide

orientation to new and transferring staff. Laboratory orientation shall be completed within two weeks of employment.

.

Orientation Process

Orientation Program What Happens EHNRI • New staff attend as per Orientation Policy Laboratory Orientation • Acquainted new staff with

o EHNRI’s mission, values and quality policy statement and goals

o Laboratory tours o Laboratory organizational chart o General safety o Laboratory’s policies o Work schedules

TITLE: Orientation Program Revision Date: Document Number: OP-3.1 Status: Draft Section: Personnel Page: 2 of 2


Responsibility

Team Leader • Develop, implement and maintain laboratory orientation program • Ensure new staff are provided with computer program access • Ensure appropriate documentation is completed

Laboratory Staff • Participate openly in all orientation programs • Notify the appropriate individual if further information is required

Supporting Documents Document Title Document # Location Orientation Program pending Retention Directives for Laboratory Records and Diagnostic Material


Safety Orientation Checklist for New Staff

pending

References

CSTM. Standards for Hospital Transfusion Services. Version 2 - September 2007; 2.12 - 2.14:13. Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007, Section I.B.11.1, X.A.1, X.D.1



TITLE: Staff Training and Initial Competency Revision Date: Document Number: OP-3.2 Status: Draft Section: Personnel Page: 1 of 3


Purpose

To ensure that staff understand the sequence of work activities and the instructions for completing them properly.

Policy

EHNRI’s Staff Training and Initial Competency Program is designed to assess and provide appropriate training for staff new to the laboratory, for staff when new or revised processes and procedures are implemented and when retraining needs have been identified. Definitions New Staff: employees new to a laboratory Competency: the ability to do a job correctly and safely, to demonstrate application of skills and knowledge and

to recognize and solve minor problems without assistance. Procedure: written work instructions that specify a way to carry out an activity, examination or step in a process. Process: series of inter-related steps involved in an activity or examination that uses resources and is managed

to transform inputs into outputs. Training: process to provide and develop knowledge, skills, and behaviors to meet requirements. Preceptors/Experts: staff who have accurate knowledge of the processes and procedures involved, who regularly

perform the procedures in which they instruct others and who demonstrate an ability to carry out the process or procedure safely and effectively following applicable instruction.


Training and Initial Competency Each laboratory shall establish training and initial competency processes and procedures required to fulfill the responsibilities and duties of the position.

• For new staff, to learn work processes and procedures • For all staff when organizational, Directorate or technological

changes affect work processes. Retaining Retaining shall be provided for staff according to the following criteria:

• Absence from the laboratory for more than six months • Training needs are identified such as repeated problems or

identified deficiencies in performance. Training and Competency Records

Each laboratory shall maintain records of training, retraining and competency results.



Training Development Process Each Laboratory shall implement a training process based on these four stages of development.

Stage Description 1. Training needs identified • Work processes and procedures identified for training. 2. Training guides developed • Objectives, methods and materials are identified and

developed. 3. Training is implemented • Preceptors are identified.

• Training is conducted. 4. Training outcomes evaluated • Training effectiveness is evaluated.

• Staff experience and feedback is evaluated. • Training is documented.

Training Program Content Training programs shall cover processes and procedures for work activities in keeping with accreditation requirements. The following table delineates components that may be part of a laboratory training program.

Training Component Contents Quality • Quality Management System

• Quality Manual • Quality Control Program • Quality Assurance Program • Patient Safety Reporting and Laboratory Non-Conformance

Reporting • Customer Service Program • Quality Indicators • Quality Initiatives and Improvements • Path of workflow (pre-analytical, analytical and post-analytical)

Computer • Laboratory Information System (LIS) • Services including e-mail, word processing, databases,

spreadsheets, etc. • Other computer applications used (document control,

continuing education, etc) Safety • See Orientation Program Work Processes and Procedures • Process in the path of workflow in which the staff member

works • Procedures performed



Responsibility

Directorate Director and Team Leader • Develop, implement and maintain a training and initial

competency program • Ensure all appropriate documentation is completed • Determine initial competency of staff • Approve staff for job task performance • Provide remedial training and education • Assess staff competency and report to laboratory management

Laboratory Staff • Participate openly in the training and initial competency program

• Notify the appropriate individual if further training or education is required

• Complete all training documentation and review results with preceptors and laboratory management

• Provide feedback and suggestions to improve the training and initial competency process

Preceptors/Expert • Provide staff training • Ensure all appropriate documentation is completed

Supporting Documents Document Title Document # Document Location Laboratory Orientation Program pending Competency Assessment Policy OP-3.3 Quality Manual Competency Assessment Procedure pending Training Checklist pending

References

NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004. NCCLS. Training and Competence Assessment; Approved Guideline—Second Edition. NCCLS document GP21-A2 (ISBN 1-56238-531-3). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004. CAN/CSA-Z15189-03 Medical Laboratories – Particular Requirements for Quality and Competence; 4.1.5, 4.2.4, 4.12.5, 4.13.3, 5.1.2, 5.1.4, 5.1.6, 5.1.11 Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007, Section I.B.5.1, I.B.10, I.B.11.2, I.B.13.2, IX.B.4, IX.F.7, IX.F.7.2, X.A.1


TITLE: Competency Assessment Program Revision Date: Document Number: OP-3.3 Status: Draft Section: Personnel Page: 1 of 3


Purpose

To ensure ongoing competency of staff

Policy

EHNRI’s Competency Assessment Program ensures that processes and procedures shall be established for monitoring staff who conduct pre-analytical, analytical and post-analytical phases of testing to verify their continued competency throughout employment. The Program also identifies the needs for remedial training or continuing education to improve skills. Definitions Competency: the ability to do a job correctly and safely, to demonstrate application of skills and knowledge and

to recognize and solve minor problems without needing assistance. Preceptors: staff who have accurate knowledge of the processes and procedures involved, who regularly perform

the procedures in which they instruct others and who demonstrate an ability to carry out the process or procedure safely and effectively following applicable instruction.

Supporting statements Competency Assessment Program

• assesses all competencies and addresses employee preparation, theoretical testing, practical examination and post-evaluation review;

• is consistently applied to both technical and non-technical staff and takes an educational rather than a disciplinary approach;

• identifies and addresses competency issues; • provides performance feedback to employees and identifies systems or

processes that require improvement; • demonstrates to employees, employers, inspectors and clients that personnel

are qualified to perform work activities.

Competency Assessments • Competency assessments shall be performed and documented on all staff annually, or as required, ensuring quality patient care.

• Each laboratory shall establish competency processes and procedures. Failure to demonstrate competency

• When there is clear evidence that a competency requirement as defined by the laboratory is not met, a staff member shall not perform that procedure until remedial action has been taken and the staff member is deemed competent to perform that procedure.

• If, after re-education and remedial training, the employee still does not meet the competence requirement, further action will be taken which may include supervisory review of work, re-assignment of duties or other action deemed appropriate.



Materials and Methods The materials and methods used to assess staff competency may include, but are not limited to, the following:

• Direct observation of: o test process or procedure o instrument maintenance and function checks o recording and reporting of test results and problems

• Review of: o worksheets, Quality Control records, Proficiency Testing results and maintenance records o problem solving skills (e.g. resolving equipment or testing problems) o results from testing of practice materials such as patient samples or assigned unknown specimens

Responsibility Directorate Directors and Team Leaders

• Develop, implement and maintain an ongoing competency assessment program

• Ensure all appropriate documentation is completed an retained according to policy

• Initiate remedial measures when competency issues are identified • Conduct progress meetings with staff • Provide remedial training and education

Laboratory Staff • Participate openly in the competency assessment program • Notify the appropriate individual if further education/training is required • Complete competency documentation and review with laboratory

management • Accept and perform assigned assessment tasks • Record all results and sign/date the appropriate documents • Accept remedial measures when competency needs are identified

Preceptors • Assess staff competency and report to management • Ensure documentation is complete

Supporting Documents : Document Title Document # Document Location Training and Initial Competency Policy OP-3.2 Quality Manual



References

Schiffens, J, Bush, V. A four-part approach to competency assessment; Clinical Laboratory Improvement Consultants, Chicago (IL); 2002 Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007, Section I.B.10, XI.B.12

CAN/CSA-Z15189-03 Medical Laboratories – Particular Requirements for Quality and Competence; 4.1.2:4; 5.1:2-3. NCCLS. A Quality System Model for Health Care – Second Edition; Approved Guideline. NCCLS document HS1-A2, November 2004; 5.2:18. NCCLS. Training and Competence Assessment; Approved Guideline—Second Edition. NCCLS document GP21-A2 (ISBN 1-56238-531-3). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.



TITLE: Continuing Education Revision Date: Document Number: OP-3.4 Status: Draft Section: Personnel Page: 1 of 3


Purpose

To support continuing education (CE) for laboratory staff.

Policy

A continuing education program is an important element of an effective quality management system. This policy provides guidance to maintain, develop, and increase the knowledge, skills, performance and attitude required by laboratory staff. CE tools utilized in the clinical laboratory may include internal and external opportunities such as seminars, courses and workshops. Supporting Statements Staff Participation • EHNRI provides education and learning opportunities to all laboratories.

• ENRI improves the dissemination of CE by establishing a network of CE contacts from each laboratory

CE Programming • EHNRI decreases the duplication of CE programs through effective coordination and communication of CE activities

• EHNRI documents internal CE programs offered and staff attendance in said programs..

Definitions Internal CE: CE opportunities provided by EHNRI. External CE: CE opportunities provided by organizations external to EHNRI. Seminar: a presentation where information on a specific knowledge or skill is given before a targeted audience. Course: a number of seminars, meetings or other matter dealing with a subject or topic of interest. Workshop: an intensive educational program for a group of people that focuses on techniques and skills in a particular field.



Continuing Education Process

ACTIVITY WHAT HAPPENS Internal Continuing Education • Staff attend CE sessions as laboratory operations and scheduling

permit • Staff access current reference materials • Staff present educational sessions

External Continuing Education • Staff forward requests to Management with o Details of cost o Specifics of activity o Benefits to individual and Institute

• Management review requests for o Cost and available funding o Scheduling o Access to CE resources o Relevance

• Decision communicated to staff Responsibility Directorate Directors and Team Leaders

• Facilitate CE opportunities/resources • Establish and maintain attendance logs for internal CE sessions • Review CE requests

Quality Officer • Collaborates with Director, Team Leader and RLCBD to identify, coordinate appropriate CE opportunities for all staff.

Laboratory Staff • Search and participate in CE opportunities • Document attendance of internal CE • Submit CE request and claim forms as required • Maintain records of external CE • Share learning experiences with peers • Keep current with technological advancements

Supporting Documents Document Title Document # Locations Travel Policy pending

Laboratory Continuing Education Request Form

pending

Attendance Log

pending



References NCCLS. Application of a Quality Management System Model for Laboratory Services; Approved Guideline – Third Edition. NCCLS document GP26-A3 November 2004;6.3:19

CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 5.1.9:14 Jansen RT, Blaton V, Burnett D, Huisman W, Queralto JM, Serah Z et al. Essential Criteria for Quality Systems of Medical Laboratories. Section 4.3. European Communities Confederation of Clinical Chemistry. Eur J Clin Chem Clin Biochem 1997;35(2):126.



TITLE: Management and Numbering of Documents Revision Date: Document Number: OP-4.1 Status: Draft Section: Documents and Records Page: Page 1 of 4


Purpose

To provide guidance in the management and control of documents and records in the laboratory.

Policy

EHNRI ensures that documents and records are managed and controlled from creation or receipt to archive according to established processes that reflect the laboratory’s commitment to quality. All documents in use are written in approved standardized formats. EHNRI will document and record the structure for creating and numbering all documents. This numbering system will identify the type of document, its code number as well as the clinical discipline.

Supporting Statements Document Control System Shall include:

• An index of all published documents, identifying current, complete and abridged versions and their distribution

• A master list that contains current versions as well as previous versions of all documents.

• A unique identifier on each document. • A process for making changes to existing documents. • A process for the review and approval of documents prior to

implementation, distribution and periodically thereafter. • A process to prevent accidental use of obsolete documents. • Established retention times for archived documents.

Document Identification System

The following process shall be used for numbering the document:

• Select the document type, either policy, technical process, procedure of form • Assign a document type, Quality Policy, Operational or Laboratory

Policy, Technical Process or Form. • Locate the appropriate template for the type of document • Use a standardized numbering system for all documents



Supporting Statements (continued)

Approvals • Prior to issue, authorized personnel approve all document released to Laboratory staff as part of the Quality Management System.

• There shall be evidence that the appropriate individual(s) has approved the document.

Document Type Approved by: Quality Management Documents Director General Laboratory Technical Procedures and related templates and forms


Standardized Identifiers

Depar tment Code Type of Document Code Chemistry CHE Quality Policy QP Pathology PAT Quality Audit QA TB Laboratory TB Operational Policy (includes

Organization and Personnel) OP

Hematology HEM Bacteriology BAC Parasitology PAR Mycology MYC Technical Processes & Procedures TP HIV HIV Forms F Rabies Diagnostic Laboratory RDL Public Health Laboratory PHL LIS LIS Safety SAF Shared Services SHS

Document Identification Examples

Document Type Unique Identifier Document Type Unique Identifier Quality Policy QP-# Operational Policy OP-# Hematology Form HEM-F-# HIV Lab Technical

Process HIV-TP-#

Chemistry Technical Procedure

CHE-TP-# TB Laboratory Form TB-F-#



Responsibility Dir ector General • Reviews and approves new and revised quality management policy

documents. Dir ector ate Dir ector • Reviews and approved new and revised technical and operational documents

and records. • Director may designate another technically qualified individual to perform

this function. • Collaborates with Team Leader, Quality Officer and RLCBD to establish and

maintain the document control system by: o Developing document and record management processes and

procedures. o Creating, reviewing and revising quality management policy, process

and procedure documents. o Establishing retention times for documents and records. o Distributing and notifying staff of new and changed documents and

records Team Leader • Reviews documents according to an established schedule, ensuring document

processes and procedures are implemented. Quality Officer • Reviews technical documents to ensure compliance with applicable

regulations and standards. Laboratory Staff • Create, revise, review and retain documents and records as assigned. Supporting Documents

Document Title Document # Document Location Policy Document Template OP 4.2 Quality Manual

Process Template OP 4.3 Quality Manual Technical Procedure Template (SOP) OP 4.4 Quality Manual Form Template OP 4.5 Quality Manual New Document Creation, Review, and Approval Process

pending

Document Distribution and Notification Process pending Use and Printing of Controlled Documents pending Creation and Maintenance of Master File//Index Process pending Record Retention Process and Directives OP 4.6 Quality Manual



Refer ences

NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004 NCCLS. Clinical Laboratory Technical Procedure Manuals; Approved Guideline—Fourth Edition. NCCLS document GP2-A4 (ISBN 1-56238-458-9). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA 2002. CAN/CSA Z15189-03 Medical Laboratories – Particular requirements for quality and competence Quality Management Program – Laboratory Service, Ontario Laboratory Accreditation (OLA) Requirements, Version 4, December 2007 Bastic, N. editor. The ISO 15189:2003 essentials – a practical handbook for implementing the ISO 15189:2003 standard for medical laboratories. 1st ed. Mississauga (ON): Canadian Standard Association; 2004.


TITLE: Quality and Policy Document Template Revision Date: February 14, 2008 Document Number: OP-4.2 Status: Current Section: Documents and Records Page: 1 of 1


< INSERT EHNRI HEADER>

Purpose Insert short purpose statement or reason for the policy to exist Policy Describe policy and to whom it applies Supporting statements Specific topic Insert any explanatory text that supports the policy and the reason for its

existence Responsibility

Position Title

Identify responsibilities

Supporting Documents List any related documents, within EHNRI Document Title Document # Document Location References List any references that may apply


Addis Ababa, Ethiopia TITLE: Process Document Template Revision Date: Document Number: OP-4.3 Status: Section: Documents and Records Page: 1 of 1



TITLE

What Happens

Who is responsible Supporting documents

1)

2)

3)


TITLE: Technical Procedure (SOP) Template Revision Date: Document Number: OP-4.4 Status: Draft Section: Documents and Records Page: 1 of 4



TITLE

Purpose

This procedure provides instructions…

Abbreviations

Materials

Reagents

Reagents preparation: Reagents stability and storage:

Supplies

Equipment

Sample

Sample type Amount required Transport and

Storage Stability



Limitations: Sample retention:

Special Safety Precautions

Maintenance

Use table if necessary

Step Action

Calibration

Calibrator Level Stability Frequency Preparation

(y/n)

Calibrator preparation: Note:

Quality Control

Control Level Stability Frequency Preparation

(y/n)

Control preparation: Note:

Procedure



Step Action

Step Action

Calculation

Result Interpretation

Expected Values

Analyte Reference Range Toxic range Analytical Range

Units Male Female

Limitations

Procedural Notes

Principle



Clinical Utility

Related Procedures and Documents

Reference


TITLE: Form Template Revision Date: Document Number: OP-4.5 Status: Draft Section: Documents and Records Page: 1 of 1



TITLE


TITLE: Retention Dir ectives for Laboratory Records Revision Date: Document Number : OP-4.6 Status: Draft Section: Documents and Records Page: 1 of 6


Purpose

To provide guidance for the retention of laboratory records.

Policy Laboratory records are retained to ensure there is an audit trail for review.. EHNRI is committed to effective records management that meets standards for retention, protection of privacy, confidentiality, maintenance, optimization of space and disposal at the proper time. This applies to all records, regardless of format, whether they are maintained in hard (paper) copy, electronically or in some other fashion.


Retention Time Per iod Retention time periods are established for all records that comply with

accreditation and regulatory requirements.

Retention Guidelines 1. Overall implications of retention and disposal of records are considered within legal, ethical and research frameworks.

2. Retention guidelines represent the minimum standards for retention of records 3. Laboratories may choose to exceed these minimum requirements based on

availability of space and other clinical factors.

Record Storage Records are stored in a suitable environment to prevent loss, unauthorized access, damage or deterioration due to the effects of factors such as temperature fluctuation, water or fire.

Retention Times:

TITLE Retention Directives for Laboratory Records Revision Date:

Document Number : OP-4.6 Status: Draft Section: Documents and Records Page: 2 of 6


The following minimum requirements meet or exceed those recommended by professional and regulatory standards. Section 1 includes all general pathology records. See sections 2 – 9 for specific discipline records having different retention periods or special requirements.

1.0 GENERAL LABORATORY

RECORD MINIMUM DURATION OF RETENTION 1.1 Accessioning/Phlebotomy

1.1.1 Aliquot Collection Labels 1 week 1.1.2 Daily Counts Discard when entered 1.1.3 Phone Log for Couriers Indefinitely 1.1.4 Physician Authorization to Collect Blood 4 months 1.1.5 Specimen Receiving Logs Indefinitely

1.2 Proficiency Testing Results 2 years

1.3 Generated Worksheets Reports 1.3.1 Electronic Worksheet (LIS) 1 year 1.3.2 Paper-based Worksheets 1 year

1.4 IQC Result LIS-indefinitely 1.5 IQC results (Paper) 2 years

1.6 Electronic Management Reports 1 year on-line/indefinite storage on DVD 1.7 Equipment Maintenance Life of instrument + 3 years

1.8 Financial Reports/Variances/Workload/Statistics 5 years

1.9 Inventory Sheets 5 year

1.10 Laboratory Methods/Manuals 20 years (archive electronically)

1.11 Patient Reports (LIS) Indefinite storage on DVD 1.12 Patient Reports-Method Specific Refer to specific SOP

1.10.1 Patient Report off Instrument Discard after results verified 1.10.2 Patient Report off Instrument and Discard after results verified

waiting for differential

1.13 Personnel Records

1.13.1 Daily Sign-in Sheets 1 year + current year 1.13.2 Evening/Weekend Duties Checklist Discard after completion 1.13.3 Holiday Rotation Records 4 years 1.13.4 HR data (PA, attendance mgt, discipline) Duration of staff employment 1.13.5 Mileage and Parking Claim Sheets 1 year + current year




1.13.6 OT Records and Books 1 year + current year 1.13.7 Standby and Callback Records 1 year + current year 1.13.8 Time Capture/Daily Attendance 1 year + current year 1.13.9 Time-off and Vacation Requests 1 year + current year 1.13.10 Work Schedules/Shift Change Requests 1 year + current year

1.14 Phone Records 1 year + current year 1.15 Fax Records (Patient records/reports) Refer to Method Specific SOP’s 1.16 Purchasing Documents

1.13.1 Packing Slips 1 year 1.13.2 PO Contracts Length of contract + 1 year 1.13.3 Reconciliation Receipt Record 1 year

1.17 Quality Control/Quality Assurance 1.14.1 QC Records (LJ graphs, cumulative 2 years

summaries, temperature charts, corrective action, etc)

1.14.2 Control assay sheets that come with 2 Years QC product

1.14.3 Intra-laboratory Examination Comparison 2 years 1.14.4 QC Review Sheets 2 years 1.14.5 Working Copies of External Surveys/PT’s 2 Years

1.18 Quality Management Documents

1.18.1 Audits 3 years 1.18.2 Committee minutes 3 years 1.18.3 Communication memos 5 years 1.18.4 Complaints/compliments 7 years 1.18.5 Court Cases Indefinite 1.18.6 Equipment Calibration 3 years

(pipettes, balances, etc.) 1.18.7 Management Reviews of QMS 3 years 1.18.8 Method/Process Validations Life of instrument + 3 years 1.18.9 NCE (lab nonconformance events) 7 years 1.18.10 Obsolete Records 10 years 1.18.11 Quality Improvement Records 3 years 1.18.12 Records of External Inspections, 3 years

Accreditation and Peer Reviews 1.18.13 Referral Lab Agreements and Contracts Duration of contract + 2 years 1.18.14 Register of Referral Specimens 3 months 1.18.15 Software Application Validation Records Life of instrument + 3 years 1.18.16 Supplier Qualification Record 3 years 1.18.17 Terms of References for Committees As long as committee exists: revised

version supersedes previous edition




1.19 Records of analysis, calculations and Interfaced: unnecessary observations affecting the result and Manual or other: 1 year laboratory report (or electronic version)

1.20 Reference Laboratory Results Refer to test specific guidance

1.21 Research Proposal Requests/Protocols/ Indefinitely Agreement Letters/Invoices

1.22 Safety Records

1.22.1 Eyewash/Shower Checklists 5 years 1.22.2 Workplace Audits 5 years

1.23 Staff Education and Competencies

1.23.1 Accessioning Error Records Indefinitely 1.23.2 Competency Records Indefinitely 1.23.3 CE Records/Attendance Logs Indefinitely 1.23.4 Education Requests Indefinitely 1.23.5 Quiz Result Indefinitely

2.0 SHARED SERVICES at Central Reception

RECORD MINIMUM DURATION OF RETENTION

2.1 Central Specimen Collection (CSA) 2.1.1 Fax Transmission Confirmations 6 months 2.1.2 Monthly Requisition Tally Sheets 1 year + current year 2.1.3 Problems Sheets (attach to requisition) 1 year 2.1.4 Way Bills for Referred-out Testing Management decision 5.1.5 Referred Out Problems (Sample/reports) 5 years

2.2 Central Reporting

2.2.1 Fax Requests for missing Reports 1 year 2.2.2 Laboratory Reporting Mail Out Records 1 year 2.2.3 Notification Records for LIS Downtime 2 years 2.2.4 Physician Addition/Change records 4 months

2.3 Blood Collection 2.3.1 Patient Comment Cards 2 years + current year 2.3.2 Suggestion Box Comments 2 years + current year




3.0 TRANSFUSION SERVICE


3.1 Operational Reports 3.1.1 Teardowns, Pending test Reports, Current + previous day

Unit Status, Expired Units, Final Dispositions Transfer of Products

3.1.2 Blood Status, Operating Room Lists, Current + previous month ABO Recheck of Red Cells 3.1.3 Autologuous Designated Units, 1 month

Dispensed Prior to Receipt Reports 3.1.4 Free text history Indefinitely

3.2 Statistical Reports 3.2.1 Workload, transfer of products 2 years 3.2.2 Month end TDR, BSR, FDL current month + previous month 3.2.3 Transfusion Report, Product Utilization, 5 years

Received Days to Outdate, Expired units to Outdate, Transfer of Product, Pooled Products

3.2.4 Canadian Blood Services Reports 5 years 3.2.5 Final Disposition Reports 1 year

3.3 Quality Assurance Reports 3.3.1 Result Review current + previous day 3.3.2 Blood Bank Exception, Product Correction, 5 years

Pre-wastage, C/T Ratios 3.3.3 Error Corrections, Lookback/Traceback Indefinitely

Notifications, Product Recalls 9.3.4 Transfusion Committee Reports 5 years 9.3.5 Inspection of Incoming Reagents 5 years 9.3.6 Physician and Staff Signatures Indefinite

3.4 Patient Records

3.4.1 Patient Records Indefinite 3.4.2 Emergency Drug Release, Special access Products Indefinite 3.4.3 Transfusion Requests and Dispense Vouchers 1 year 3.4.4 Transfused Tags Current + previous month 3.4.5 Patient Transfusion Records Indefinite


3.5 Process Analysis and Computer Records

9.5.1 Program Development Indefinite 9.5.2 Validation Reports Indefinite 9.5.3 Installation Reports Indefinite 9.5.4 System Maintenance & Operations Indefinite




Responsibility

Directorate Directors and Team Leaders • Establish and periodically review retention directives. • Ensure adequate and appropriate storage space is

available. Quality Officer • Ensures policies and procedures are in compliance with

regulations and standards. Laboratory Staff • Retains records and specimens according to established

processes. • Prepares suitable specimen aliquots for storage.


Document Name Document # Document Location

Refer ences

College of American Pathologists, Laboratory Accreditation Newsletter. March 2001 National Pathology Accreditation Advisory Council, Retention of Laboratory Records and Diagnostic Material, 3rd Edition, 2002. Ontario Association of Medical Laboratories, Guidelines for the Retention of Laboratory Records & Materials, CLP020-001, Revised June 2006. Canadian Society of Cytology, Guidelines for Practice and Quality Assurance in Cytopathology, 3rd Revision, January 2005. Canadian Association of Pathologists, The Retention and Use of Human Biologic Materials, November, 2005. Canadian Standards Association, Z902-04 Blood and Blood Components, Mississauga, Ont. March 2004. Nova Scotia Association of Clinical Laboratory Managers, Retention of Laboratory Records and Diagnostic Material, November 2007


TITLE: Guidelines for Citing Reference Material Revision Date: Document Number: OP-4.7 Status: Draft Section: Documents and Records Page: 1 of 2


Purpose To provide guidelines for citing references in laboratory documents using the Vancouver format. These guidelines will produce consistency in the form, style and structure of referencing material. Policy When written scientific documents are developed in the laboratory it is essential that the material used in their preparation has been cited appropriately in the reference listing. This reference list includes all items cited in the document in the order in which they have been used.

According to the Clinical and Laboratory Standards Institute (CLSI), “Procedures need to reference the source of the information, where applicable. The references may originate from any of the following:

• Manufacturer’s product literature such as package inserts and operator’s manuals; • Text books; • Published standards and guidelines; • Laboratory policy manuals; • Unpublished information obtained from experts in the field and • Applicable regulations.”

Other sources of information can be obtained from journals, CD-ROMS, pamphlets, internet sources and conference presentations. It is well known that citing references acknowledges the material supporting the document thus giving credibility to the document.

(1)

(2)

Although accreditation standards do not stipulate which format to be used, the Vancouver style is the preferred method based on CLSI guidelines which clearly states “references should be listed in a standard medical format, using the style of the Journal of the American Medical Association…. (1, 3) This is the Vancouver format.

TITLE: Guidelines for Citing Reference Material Revision Date: Document Number: OP-4.7 Status: Draft Section: Documents and Records Page: 2 of 2



The following Vancouver style is to be incorporated when citing reference material in laboratory documents: Wilson, CRM. Hospital-wide quality assurance models for implementation and development. 1

Books with author: sted. Toronto (ON): W.B. Saunders Company Canada Ltd.; 1978.

Westcott, RT, editor. The certified manager of quality/organizational excellence handbook. 3

Book, editor only: rd ed. Milwaukee (WI): American Society for Quality; 2006.

The University of Queensland Library. References/Bibliography Vancouver style [Online]. 2005 [cited 2008 Feb 04] Available from:

Website:

URL:http:/www.library.uq.edu.au/useit Heart and Stroke Foundation. Dietary fat and cholesterol [pamphlet]. The Heart and Stroke Foundation; Item No. 44819

Pamphlet:

ICON 25Package Insert:

hCG Immunochemical test for hCG in urine and serum. Fullerton (CA): Beckman Coulter Inc.; 2004

RapidTMAna II system. Lenexa (KS); Remel; 2004 Shematek, G. Laboratory safety – starting early. CJMLS 2006; 68(2): 87-88 Journal Article: Shematek, G, Wood,W. Laboratory safety CSMLS guidelines. 6CD-ROM:

th ed. Hamilton

(ON): Canadian Society for Medical Laboratory Science; 2006 (Clinical and Laboratory Standards Institute. Laboratory Documents: Development and Control; Approved Guideline – Fifth Edition. CLSI document GP2-A5 [ISBN 1-56238-600-X]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne Pennsylvania 19087-1898 USA, 2006) Please note this is a modified version of the Vancouver style but is recommended and suggested for citing purposes by the CLSI.

CLSI Guidelines:

Responsibility All laboratory personnel who prepare documents are responsible for employing the Vancouver style of citing reference material References

1. (Clinical and Laboratory Standards Institute. Laboratory Documents: Development and Control; Approved Guideline – Fifth Edition. CLSI document GP2-A5 [ISBN 1-56238-600-X]. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne Pennsylvania 19087-1898 USA, 2006) 2. The University of Queensland Library. References/Bibliography Vancouver style [Online]. 2005 [cited 2008 Feb 04] Available from URL:http:/www.library.uq.edu.au/useit 3. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication [Online]. 2006 [cited 2008 Feb 4] Available from: URL:http:/www.icmje.org

http://www.library.uq.edu.au/useit

http://www.library.uq.edu.au/useit

http://www.icmje.org



TITLE: Document Creation, Review and Change Process Template

Revision Date:

Document Number: OP-4.8 Status: Draft Section: Documents and Records Page: 1 of 1


SECTION A Document Title: Document Number: Requested By: Version Number: Date Initiated: Document Type: Form Policy Procedure Other Check one: Changed Document New Document Are any related documents affected? Yes No If yes, list here. Also prepare additional document change request form.

This section must be complete before changes will be made Reason for Creation/Revision/Review: Change From: Change To: If no changes recommended, forward to Team Leader Is a copy of requested revisions attached? Yes No Attach copy to form Indicate in reason above, if electronic copy e-mail to appropriate authority level SECTION B Will any document be obsolete following the creation or change of that document? Yes No If yes list here. Is training required? Yes No Notify Director SECTION C The following activities shall be carried out in the order listed

Document Control Process Activity Authority Initials Date

Changes approved Quality Officer Changes approved Team Leader Changes approved Directorate Director Changes approved (if required) Director General



TITLE: Calibration of Balances Revision Date: Document Number: OP-5.1 Status: Draft Section: Equipment, Reagents and Supplies Page: 1 of 2


Purpose

To provide guidance for calibration of balances. Policy

EHNRI shall have a calibration and verification program for balances. This program shall meet applicable accreditation and regulatory standards. Supporting statements

Identification Balances are identified using the unique identifier from the Equipment Inventory Record

Calibration status Each laboratory identifies the calibration status and indicates due date of next calibrations.

Operation Balances are operated, maintained and verified by trained personnel using approved processes and procedures.

Maintenance Schedules, instructions and records are maintained for maintenance, calibration and verification. All documentation is maintained according to the Retention Directives for Laboratory Records and Diagnostic Material policy.

Non-conformances Processes are in place to identify and address non conformances.

Responsibility Director General • Reviews and approves all Equipment, Reagents and Supplies policies

• Ensures appropriate resources are available. Directorate Directors and Team Leaders

• Oversees the approved calibration program • Develops implements and updates/maintains the documentation of the

balance calibration program. • Ensure that processes, procedures and documentation related to the balance

calibration are performed. • Review revised or changed documents • Notifies laboratory staff of revisions or changes to this policy.

Quality Officer • Ensures policies and procedures are in compliance with standards. • Develops implements and updates/maintains the documentation of the

calibration program. • Monitors calibration data for acceptability • Reviews all non conformances and corrective actions

Laboratory Staff • Follows all processes and procedures in the calibration program • Identifies non conformances and notifies the appropriate personnel • Performs corrective actions as assigned • Completes necessary documentation. • Reviews revised or changed documents.

TITLE: Calibration of Balances Revision Date: Document Number: OP-5.1 Status: Draft Section: Equipment, Reagents and Supplies Page: 2 of 2

Prepared by: Authority:



Document Name Document # Document Location Equipment, Reagents and Supplies QP-1.2.4 Quality Manual Retention of Records and Diagnostic Material OP-4.6 Quality Manual Nonconforming Laboratory Events OP-8.2.1 Quality Manual Laboratory Nonconforming Event Report Form OP-8.2.2 Quality Manual

References

ISO 15189:2007(E) Medical Laboratories-Particular Requirements for Quality and Competence; 4.2.5:6; 5.3.2:15; 5.3.4:16; 5.3.11:17; ISO/IEC. ISO/IEC 17025:2005(E) General Requirements for the Competence of Testing and Calibration Laboratories 2005; 5.5.6:16.



TITLE: Calibration of Pipettes Revision Date: Document Number: OP-5.2 Status: Draft Section: Equipment, Reagents and Supplies Page: 1 of 2


Purpose

To provide guidance for calibration of pipettes. Policy

The laboratory shall have a calibration and verification program for pipettes. This program shall meet applicable accreditation and regulatory standards. Supporting statements Identification Pipettes are identified using the unique identifier from the Equipment Inventory

Record. Calibration status Each laboratory identifies the calibration status and indicates due date of next

calibrations. Operation Pipettes are operated, maintained and verified by trained personnel using approved

processes and procedures. Maintenance Schedules, instructions and records are maintained for maintenance, calibration and

verification. All documentation is maintained according to the Retention Directives for Laboratory Records and Diagnostic Material policy.

Non-conformances Processes are in place to identify and address non conformances.

Responsibility Director General • Reviews and approves all Equipment, Reagents and

Supplies policies • Ensures appropriate resources are available.

Directorate Director and Team Leaders • Oversee the approved calibration program • Ensure that processes, procedures and documentation

related to the pipette calibration are performed. • Review all non conformances and determines corrective

action • Review revised or changed documents • Develops implements and updates/maintains the

documentation of the pipette calibration program. • Notifies laboratory staff of revisions or changes to this

policy. Quality Officers • Ensures policies and procedures are in compliance with

standards. • Develops implements and updates/maintains the

documentation of the calibration program. • Monitors calibration data for acceptability • Reviews all non conformances and corrective actions

TITLE: Calibration of Pipettes Revision Date: Document Number: OP-5.2 Status: Draft Section: Equipment, Reagents and Supplies Page: 2 of 2


Laboratory Staff • Follows all processes and procedures in the calibration program

• Identifies non conformances and notifies the appropriate personnel

• Performs corrective actions as assigned • Completes necessary documentation. • Reviews revised or changed documents.


Document Name Document # Document Location Equipment, Reagents and Supplies QP-1.2.4 Quality Manual Retention Directives for Laboratory Records and Diagnostic Material


Nonconforming Laboratory Events OP-8.2.1 Quality Manual Laboratory Nonconforming Event Report Form OP-8.2.2 Quality Manual

References

ISO/IEC 17025:2005(E) General Requirements for the Competence of Testing and Calibration Laboratories 2005;5.5.6:16. CAN/CSA-Z15189-03Medical Laboratories-Particular Requirements for Quality and Competence; 4.2.5:6; 5.3.2:15; 5.3.4:16; 5.3.11:17;


TITLE: Reagent Water Quality Monitoring Program

Revision Date:

Document Number: OP-5.3 Status: Draft Section: Equipment, Reagents and Supplies Page: 1 of 2


Purpose

To provide guidance for assuring the quality of water used in laboratory testing.

Policy

EHNRI shall operate a water quality monitoring program. This program shall ensure that the class of water available for analytical procedures meets the criteria as described by the Clinical and Laboratory Standards Institute (CLSI).

Supporting statements Class of Water The class of water required for a given purpose is defined. The water testing program

ensures that specifications are met for the defined class.

Standard Water purification system design conforms to the standards as stated in CLSI document C3-A4. Water from purification systems is validated for suitability in a given application.

Maintenance Maintenance and sanitation, with appropriate documentation, is accomplished using

established processes and procedures.

Results Results of testing are maintained and subjected to trend analysis. All non conformances and corrective actions are documented.

Responsibility Director General • Reviews and approves Reagent Water Quality policy

• Ensures appropriate resources are available. Directorate Director and Team Leaders

• Ensure that processes, procedures and documentation related to the reagent water quality are performed.

• Review all non conformances and determines corrective action • Review revised or changed documents • Notifies laboratory staff of revisions or changes to this policy.

Quality Officer • Ensures policies and procedures are in compliance with standards. • Develops implements and updates/maintains the documentation of the water

quality monitoring program. • Monitors results for acceptability • Reviews all non conformances and corrective actions

TITLE: Reagent Water Quality Revision Date: Document Number: OP-5.3 Status: Section: Equipment, Reagents and Supplies Page: 2 of 2


Laboratory Staff • Follows all processes and procedures in the reagent water quality program • Identifies non conformances and notifies the appropriate personnel • Performs corrective actions as assigned • Completes necessary documentation. • Reviews revised or changed documents.




Nonconforming Laboratory Events OP-8.2.1 Quality Manual Laboratory Nonconforming Event Report Form OP-8.2.2 Quality Manual

References Clinical and Laboratory Standards Institute (CLSI). Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved Guideline—Fourth Edition. CLSI document C3-A4 (ISBN 1-56238-610-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006. ISO/IEC 17025:2005(E) General Requirements for the Competence of Testing and Calibration Laboratories 2005; 5.5.6:16. CAN/CSA-Z15189-03Medical Laboratories-Particular Requirements for Quality and Competence; 4.2.5:6; 5.3.2:15; 5.3.4:16; 5.3.11:17;



TITLE: Environmental Monitoring Program Revision Date: Document Number: OP-5.4 Status: Section: Equipment, Reagents and Supplies Page: 1 of 2


Purpose

To provide guidance for effective monitoring of equipment temperature, humidity and alarm systems.

Policy

EHNRI shall ensure that the monitoring of temperature, humidity and alarm systems is implemented when indicated by applicable accreditation and regulatory standards, where valuable assets are at risk, or when laboratory management determines it is necessary.

Supporting statements Monitoring requirements

1. The equipment inventory record identifies equipment that requires monitoring. 2. Applicable standards and manufacturers’ recommendations are used to indicate

the frequency of monitoring as well as the limits of non conformances.

3. Calibrated or traceable thermometers and hygrometers are used. 4. When alarms are required, there are processes and procedures for establishing

alarm limits and responding to alarms. 5. Reference temperature and humidity monitoring devices are annually calibrated to

a traceable standard. 6. Other thermometers are traceable and accuracy is verified annually against the

reference devices.

Documentation All documentation is maintained according to the Retention Directives for Laboratory Records policy.

Non-conformances Each laboratory has processes to identify and address non conformances.

TITLE: Environmental Monitoring Program Revision Date:



Responsibility

Director General • Reviews and approves all Equipment, Reagents and


Directorate Director and Team Leaders • Ensure that processes, procedures and documentation related to the Temperature and Humidity Monitoring and Alarm program are performed.

• Establish acceptable ranges for monitoring and alarm systems

• Review revised or changed documents • Notifies laboratory staff of revisions or changes to this

policy. Quality Officer • Ensures policies and procedures are in compliance with

standards. • Develops implements and updates/maintains the

documentation of the environmental monitoring program. • Monitors results for acceptability • Review all non conformances and determines corrective

action Laboratory Staff • Follows all processes and procedures in the Temperature

and Humidity Monitoring and Alarm program. • Identifies non conformances and notifies the appropriate

personnel • Performs corrective actions as assigned • Completes necessary documentation. • Reviews revised or changed documents.


Document Name Document # Document Location Equipment, Reagents and Supplies QP-1.2.4 Quality Manual Retention of Records and Diagnostic Material OP-4.6 Quality Manual Nonconforming Laboratory Events OP-8.2.1 Quality Manual Laboratory Nonconforming Event Report Form OP-8.2.2 Quality Manual

References

CAN/CSA-Z15189-07 Medical Laboratories-Particular Requirements for Quality and Competence; 5.2.5



TITLE: Handling, Storage and Transport of Equipment, Reagents and Supplies

Revision Date:



Purpose To ensure the integrity of equipment, reagents and supplies is maintained at all times.

Policy

EHNRI shall handle, store and transport all equipment, reagents and supplies in a safe manner to ensure they are maintained within optimal conditions.

Supporting statements Maintaining integrity All equipment, reagents and supplies are safely handled, stored and transported

according to manufacturer’s recommendations or internal standards to ensure quality during use, repair or transport.

Removing from service Processes and procedures are established for the decontamination, disassembly

and assembly of equipment being sent out for service, storage or disposal. Appropriate documentation and retention of records is maintained.

Returning to service EHNRI ensures that equipment sent out from the laboratory is functioning

correctly before being put back in service.

Staff training Staff receive training on the safety features of equipment operations and the handling and storage of associated chemicals.

Safety Appropriate safety precautions are observed by staff when handling, storing,

transporting or disposing of equipment, reagents and supplies.

Responsibility

Director General • Reviews and approves policy

• Ensures appropriate resources are available Directorate Directors and Team Leaders • Ensure that processes, procedures and documentation

are performed • Review revised or changed documents • Notifies laboratory personnel of revisions or changes

to this policy

TITLE: Handling, Storage and Transport of Equipment, Reagents and Supplies

Revision Date:



Quality Officer

• Ensures policies and procedures are in compliance with regulations, standards and manufacturers’ instructions.

• Review all non conformances and determines corrective action

Laboratory Staff • Follows all processes and procedures in the handling, storage and transport of equipment, reagents and supplies

• Identifies non conformances and notifies the appropriate personnel

• Performs corrective actions as assigned • Completes necessary documentation • Reviews revised or changed documents


Document Name Document # Document Location Equipment, Reagents and Supplies QP-1.2.4 Quality Manual – Volume 1 Retention Directives for Laboratory Records and Diagnostic Material

OP-4.10 Quality Manual – Volume 1

References

CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 5.3.12

CLSI. Protection of Laboratory Workers From Occupationally Acquired Infections; Approved Guideline - Third Edition.CLSI document M29-A3March 2005; 11:64-73.



TITLE: Medical Device and Product Alerts Revision Date: Document Number: OP-5.6 Status: Draft Section: Equipment, Reagents and Supplies Page: 1 of 3


Purpose To provide guidance in the management of medical device and product alerts.

Policy Equipment and products that have been recalled by manufacturers, suppliers or other sources, or are cited for a potential hazard may pose a significant health and safety risk to patients and staff. EHNRI ensures all alerts are effectively managed by establishing protocols for their receipt, distribution, resolution and documentation in a timely and appropriate manner. Definition Alert: “Alert” is a form of communication that warns users of a medical device or product of a problem or hazard that compromises patient care or worker safety. Alerts include manufacturer safety notices, corrective actions, product recalls and/or withdrawals that are typically issued by the manufacturer or a regulatory or independent agency. Supplier: Provides information and tracking (Alerts Tracker) about medical device alert, reagents and recalls.

Supporting statements Notification of alerts 1. EHNRI receives notification of alerts from the manufacturer.

2. EHNRI promptly distributes these alerts for investigation throughout the laboratory.

3. EHNRI ensures that purchase and sales agreements include a provision for alerts.

Response Plan 1. A response plan, detailing the steps necessary to process the alert, is developed. The plan includes location of the equipment/product, end-users affected, resources required, timelines for completion and appropriate documentation.

2. Alerts contain identification of the product and problem or hazard, instructions on what should be done and a means of reporting. The manufacturer or supplier should provide sufficient information necessary for the laboratory to identify the scope of the equipment/product alert and potential areas that may be affected.

3. EHNRI investigates the alert and prepares a report of the actions taken. The procedure for replacing affected equipment/product will be verified with the respective vendor. The final report is forwarded to the Director General for review and is retained according to the Retention Directives for Laboratory

TITLE: Medical Device and Product Alerts Revision Date: Document Number: OP-5.6 Status: Section: Equipment, reagents and Supplies Page: 2 of 3


Records and Diagnostic Material policy. 4. Each laboratory maintains inventories of equipment, reagents and supplies to

facilitate the investigation of alerts. 5. EHNRI will take action to enable recovery of services in the event equipment/

product is lost due to an alert or recall.

Staff Training EHNRI provides training to staff responsible for investigating alerts.

Reporting Team Leaders and Quality Officers will provide reports yearly and at the time of any major quality review. These reports may include information on the number of alerts and impact on the provision of service.

Responsibility Director General • Reviews and approves new or changed policy

• Communicates with clients affected by product alerts Directorate Directors and Team Leaders • Receives alert notifications

• Initiates and reviews alert investigations • Communicates with clients affected by alerts • Reviews and retains the completed response plan • Provides training for designated staff • Notifies staff of any revisions to the policy

Quality Officer • Receives alert notifications in the absence of the Team Leader

• Provides an annual report on alerts for the Quality Council

Laboratory Staff • Participates in alerts investigations • Completes required documentation




Alert Response Plan Process OP-4.12 Quality Manual Medical Device and Product Alerts Response Plan Report Template


TITLE: Medical Device and Product Alerts Revision Date: Document Number: OP-5.6 Status: Section: Equipment, reagents and Supplies Page: 3 of 3


References

Clinical and Laboratory Standards Institute (CLSI). A Model for Managing Medical Device Alerts (Hazards and Recalls) for Healthcare Organizations; Approved Guideline. CLSI document HS11-A (ISBN 1-56238-590-9). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005.


TITLE: Centrifuge Management Program Revision Date: Document Number: OP-5.7 Status: Draft Section: Equipment, Reagents and Supplies Page: 1 of 2


Purpose

To provide guidance for the management of centrifuges. Policy

EHNRI shall have a centrifuge management program. To meet applicable accreditation and regulatory standards, the program shall include training, maintenance, periodic operational evaluation and requirements for replacement. Supporting statements Procurement Centrifuges are procured using approved processes and guidelines.

Installation 1. Each centrifuge is entered into the equipment inventory record and assigned a

unique identification number. 2. An initial inspection is completed by qualified personnel before a centrifuge is

placed into service.

Training Operators receive training on centrifuge operating principles, hazards, best practices, maintenance and troubleshooting.

Operation 1. Standard Operating Procedures are developed and used for the operation of centrifuges.

2. Checklists are available to assure centrifuge parameters are set properly and that visual inspection of the bowl, rotor and accessories and /or routine disinfection is performed as specified.

Maintenance 1. All scheduled operational and preventive maintenance is performed and documented. 2. A yearly inspection by qualified personnel is included as part of the preventive maintenance program. 3. All centrifuges are evaluated periodically to assure reliability, safety and suitability for the workload and procedures performed.

Replacement A replacement program is developed to ensure centrifuges are replaced as required.

Responsibility Director General, or designee • Reviews and approves all Equipment, Reagents and


Directorate Directors and Team Leaders • Oversee the approved centrifuge management program. • Ensure that processes, procedures and documentation

related to the centrifuge program are performed.

TITLE: Centrifuge Management Program Revision Date: Document Number: OP-5.7 Status: Draft Section: Equipment, Reagents and Supplies Page: 2 of 2


• Review revised or changed documents • Develop a replacement program • Notifies laboratory staff of revisions or changes to this

policy. Quality Officer • Ensures compliance with standards, policies, procedures

and manufacturers’ instructions. • Review all non conformances and determines corrective

action Laboratory Staff • Follows all processes and procedures in the centrifuge

management program. • Identifies non conformances and notifies the appropriate

personnel • Performs corrective actions as assigned • Completes necessary documentation. • Reviews revised or changed documents.


Document Name Document # Document Location Equipment, Reagents and Supplies QP-1.2.4 Quality Manual Retention of Records and Diagnostic Material OP-4.10 Quality Manual Nonconforming Laboratory Events OP-11.B.2 Quality Manual Laboratory Nonconforming Event Report Form OP-11.B.4 Quality Manual Centrifuge Operating Procedure pending Centrifuge Guidelines and Checklists pending

References ISO. ISO 15189:2007(E) Medical Laboratories-Particular Requirements for Quality and Competence; 4.2.5:6; 5.3.2:15; 5.3.4:16; 5.3.11:17; 15.15 ISO/IEC. ISO/IEC 17025:2005(E) General Requirements for the Competence of Testing and Calibration Laboratories 2005; 5.5.6:16. Canadian Society for Medical Laboratory Science. Shematek GM, WoodW. Laboratory Safety. CSMLS Guidelines. 6th Ed. Hamilton: CSMLS; 2001; 4.2:9.


TITLE: Laboratory Path of Workflow Revision Date: Document Number : OP-6.1.1 Status: Draft Section: Process Control – Pre-Analytical Page: 1 of 3


Purpose

To describe the sequential activities and identify work processes in the path of workflow for a clinical specimen to proceed through each phase of the laboratory testing process.

Policy

EHNRI has a defined path of workflow that represents the sequence of activities from the receipt of a requisition for service, through the provision of that service and any necessary follow-up consultation.

Supporting statements Identifying and Managing the Path of Workflow

1. EHNRI flowcharts its work processes to clearly identify the sequence of work activities (Appendix 1). These flowcharts are used as tools for training new staff, or when dealing with non-laboratory personnel.

2. The Laboratories shall follow a sequence of work processes by developing a detailed flowchart specific to their area.

3. Processes in EHNRI’s path of workflow begin with the request for service or testing and ends with the provision of test results and interpretations to its customers.

4. Personnel, involved along the entire path of workflow, are trained in their respective work processes and procedures and perform them competently to ensure EHNRI’s best contribution to quality patient care and effective Public Health Emergency Management.

Quality System Essentials (QSEs)

EHNRI applies Quality System Essentials (QSEs) to manage the path of workflow to ensure quality and patient safety.



Results Report Results Archiving Specimen Management

EHNRI Laboratory Path of Wor k Flow

Lab Information System (LIS) Statistics

Review of Test Request Customer Registration and Billing Specimen Collection Specimen Transport Specimen Receipt Specimen Processing

Quality System Essentials: Foundations that apply to all operations in the path of workflow

Customer

Laboratory

Services

Pre-Analytical Post-Analytical Information Management

PATHS OF WORKFLOW

Specimen Testing Results Review and Interpretation

Analytical

Organization Personnel Equipment Purchasing and Inventory Facilities and Safety

Process Control Documents and Records Information Management

Assessments Process Improvement Occurrence Management Customer Satisfaction

The Measurements The Work The Laboratory




Document Name Document # Document Location Training and Initial Competency OP-3.2 Quality Manual Competency Assessment Program OP-3.3 Quality Manual

Refer ences

Managing Laboratory Quality – A Systematic Approach, Berte, L.M., Lab Medicine, Volume 35, Number 10 [online]. October 2004 [cited 29 September, 2008]. Available from URL:http:/www.labmedicine.com

http://www.labmedicine.com


TITLE: Specimen Acceptance and Rejection Revision Date: Document Number: OP-6.1.2 Revision: Draft Section: Process Control – Pre-Analytical Page: 1 of 4


Purpose

To establish guidelines and minimum requirements for the acceptance or rejection of specimens processed within EHNRI. If a specimen is not properly labeled and identified, EHNRI cannot be confident that the specimen comes from the patient identified on the requisition. If specimens do not meet the appropriate time and transport requirements, erroneous results may lead to incorrect diagnosis and treatment of the patient.

Policy EHNRI shall ensure that:

• All specimens accepted by the laboratory are suitable for testing to ensure a quality test result. • All rejected specimens are denoted by standardized cancellation comments and report phrases (LIS

Markers). Standardized comments may be edited to fit the situation. • The safety of all laboratory personnel is maintained.

A record will be kept of all rejected specimens. Opportunities for improvement will be identified through periodic audits of rejection rates. If a compromised specimen must be accepted (irretrievable), a comment will be placed on the patient’s report to indicate the nature of the problem. Definitions Irretrievable: Difficult or impossible to retrieve or repeat



Supporting statements Specimen Labelling Requirements

1. Specimens are clearly identified with a legible patient’s legal name and a minimum of one other identifier as listed below: 1.1. Billing or free number 1.2. LIS generated number 1.3. Other unique identifiers associated with a patient may include:

1.3.1. Passport number 1.3.2. Driver’s license

1.4. Exception: Unique codes in the case of anonymous testing may be used in place of legal name. No second unique identifier required.

2. Specimens have the date of collection handwritten on each specimen label. 3. The time of collection is recorded for time sensitive samples.

Specimen type Specimens must be of the correct sample type and submitted in the correct

container.

Requisition Specimens are accompanied by a requisition as per the requirements stated in the Requisition Policy.

Transportation Requirements

Specimens are transported as per requirements stated in the Transport of Specimens Policy.

Receipt/Handling Specimens are received and processed in the laboratory within prescribed time-lines for collection/centrifugation/processing as established by each laboratory division.

Rejection Criteria Each laboratory division establishes specimen rejection criteria and procedures appropriate for the individual test requirements.

Exceptions 1. Specimens not meeting the minimum requirements as stated above may be accepted by each laboratory division under the following circumstances. 1.1. The test is TIME SPECIFIC and delay for a new specimen would

compromise patient care (i.e. drug levels). 1.2. The specimen has been acquired through an invasive procedure or is

irretrievable (i.e. Sterile Body Fluids, tissue specimens, pathology sample).

1.3. Specimens submitted are from a patient in a life threatening situation. 1.4. Additional exceptions according to individual laboratory’s policies. 1.5. When compromised or irretrievable specimens are accepted for

processing, a signature must be obtained from the person responsible for specimen collection.

.



Responsibility Director General • Reviews and approves policy. Directorate Directors and Team Leader

• Ensure staff receives specimen acceptance and rejection training.

• Review, revise and implement the policy. • Review and approve the Specimen Collection Handbook.

Quality Officer • Ensures compliance with policies, standards • Monitors quality indicators and works with Team Leader

and staff on process improvement. Laboratory Staff • Assesses the acceptability of a specimen before it is

processed. • Notifies the patient care area/physician if a specimen is

rejected. • Enters the appropriate cancellation codes, report phrases

and standardized text comments into LIS. • Files Patient Safety or Laboratory Nonconforming.

reports.

Supporting Documents Document Name Document # Document Location Mislabelled/unlabelled Laboratory Specimens for Diagnostic Testing

pending

Specimen Collection –Manual or Handbook pending Specimen Collection Process pending Accidental Exposure to Blood and/or Potentially Infectious Body Substances

pending

Microbiology Specimen Rejection Policy pending Accessioning User Reference Manual pending Sample Integrity and Rejection Policy pending Interacting and Handling Medical-Legal Samples/Requests CHE-10-002

pending

Internal Audit Reporting Policy pending Specimen Collection Policy TTS-P700.302 pending Specimen Adequacy A.1.3 pending Hemolyzed Blood Samples, Management of CC 85-026 pending



References 1. Clinical and Laboratory Standards Institute. Procedure for Handling and Processing of Blood

Specimens: Approval Guidelines H18-A3, 3rd

edition. Wayne, PA: NCCLS: 2004.

2. Clinical and Laboratory Standards Institute. Procedures for the Collection and Diagnostic Blood Specimens by Venipuncture; Approved Standard H3-A5, 5th

edition. Wayne, PA: NCCLS; 2003.


TITLE: Specimen Label Requirements Revision Date: Document Number: OP-6.1.3 Revision: Section: Quality Manual Page: 1 of 2


Purpose

To establish guidelines for the proper labeling criteria of all samples to be processed within EHNRI. Policy

EHNRI shall ensure that:

• All specimens accepted by the laboratory are suitable for processing. • All rejected specimens are denoted with cancellation codes, report phrases and standardized text comments

as appropriate to the situation. Standardized text comments may be edited to fit the situation if necessary.

Definitions Irretrievable: Difficult or impossible to retrieve or recover. Supporting statements Label Information 1. Specimens are clearly identified with a legible patient’s legal name and a minimum

of one other identifier as listed below: 1.1. DOB 1.2. Billing number

2. Specimens are labelled by the collector at the time and point of collection.

3. Specimens are labelled with the date of collection on each label. 4. The time of collection is recorded for time sensitive samples.

Label Placement 1. Labels are applied in such a way as not to interfere with the opening/closing of the specimen container.

2. Labeling shall not interfere with bar-coded labels on the original specimen

container.

3. When placing a secondary label over an original label, the secondary label is placed so that the full name of the patient on the original label is still visible on the specimen

Aliquot Labels All specimen aliquots, portions and slides are traceable to the original requisition and specimen.

Slides Slides are labelled as outlined in section 1.0 and the date of collection (time is not required).

Exceptions Specimens not meeting the minimum labeling requirements as stated above may be accepted according to the Specimen Acceptance and Rejection policy

TITLE: Specimen Label Requirements Revision Date: Document Number: OP-6.1.3 Revision: Section: Quality Manual Page: 2 of 2


Responsibility

Director General • Reviews and approves policy Directorate Director and Team Leader • Ensures staff receive specimen labeling training

• Reviews and revises policy Quality Officer • Ensures compliance with policies, standards

• Monitors quality indicators and works with Team Leader and staff on process improvement.

Laboratory Staff • Assesses the suitability of the label • Notifies appropriate area when specimen is rejected due to

unacceptable labeling • Enters appropriate markers/comments in LIS • Completes PSR/NCE reports when required


Document Name Document # Document Location Process for Mislabelled Laboratory Specimens for Diagnostic Testing.

OP-6.1.4

Unlabeled Laboratory Specimens for Diagnostic Testing. pending Specimen Collection Manual pending Specimen Collection Process. pending Microbiology Specimen Rejection Policy. pending Specimen Collection Policy pending Specimen Receipt, Centrifugation, Separation, Labelling and Storage

pending

Specimen Acceptance and Rejection 6.1.2 pending Rejected Sample Report pending Sample Integrity and Rejection Policy pending

References 1. Clinical and Laboratory Standards Institute. Procedure for Handling and Processing of Blood Specimens:

Approval Guidelines H18-A3, 3rd

edition. Wayne, PA: NCCLS: 2004.

2. Clinical and Laboratory Standards Institute. Procedures for the Collection and Diagnostic Blood Specimens by Venipuncture; Approved Standard H3-A5, 5th

edition. Wayne, PA: NCCLS; 2003.


TITLE: Process for Mislabeled/Unlabeled Specimens Revision Date: Document Number: OP-6.1.4 Status:Draft Section: Process Control – Pre-Analytical Page: 1 of 1


Purpose: To provide instructions for the proper handling of mislabeled and unlabeled specimens Definition Mislabeled Specimen The patient identification on the specimen does not match the identification on the requisition

Is the specimen

Refer to list of Irretrievable specimens for each division

Mislabeled Unlabeled Unlabeled Mislabeled

o Receive and cancel the specimen in the LIS system or Log Book

o Document the communication in the LIS using standardized LIS comments

Notify the patient care area to inform them of the rejection

Patient Safety or Lab Non-conformance Report filed

o Notify the patient care area to inform them of the compromised sample.

o Personnel from the area must come to lab to identify and label the specimen and sign appropriate record log

Document the compromised sample and who identified using standardized LIS comments

If there is no patient identification process the specimen as per divisional requirements; do not report results until specimen is identified. Store the specimen under the appropriate conditions in the event it is identified.

Personnel from the area must come to lab to identify and label the specimen and to sign appropriate record log

Retrievable

Irretrievable

A mislabeled or unlabeled specimen is received in the Laboratory. (Patient Misidentification)

NO YES


TITLE: Laboratory Test Utilization Revision Date: Document Number : OP-6.1.5 Status: Draft Section: Process Control – Pre-Analytical Page: 1 of 3


Purpose

A regulated process of test introduction, replacement or removal with monitoring of ordering patterns will ensure the requirements of the customers are met while allowing the Institute to organize the use of staff expertise and instrumentation while exercising fiscal responsibility.

Policy

This policy provides guidance for the regulation, control and coordination of the introduction, replacement or removal of tests from its published menu and the monitoring of ordering practices. This will be done by the Directorate in consultation with clinicians and healthcare providers and approved by EHNRI’s Management. Supporting Statements Introduction of a New Test

Before a new test is introduced and approved in the laboratory, the following guidelines shall be followed:

• Explain the reason(s) for the test, its clinical relevance and whether the test is accepted practice for its intended use.

• Determine if required instrumentation is in place. • Determine the costs of the test. • Determine if the test can be introduced within the existing staff numbers or if

additional staff are required. • Determine the degree of technical expertise required for analyzing the test. • Prepare and send a report to the EHNRI Management for review and approval. • Set a time frame for introduction if the test is approved. • Include in test menu and communicate to users.

Change in Test Availability

Before a test is replaced, removed or decreased in frequency, the following guidelines shall be followed:

• Explain the impact on workload, workflow and laboratory budget. • Determine if the test will be required on a STAT basis if reduced in frequency. • Evaluate the impact on reagent stability and instrumentation utilization if the

test is to be reduced. • Perform a cost analysis if the test is to be replaced or decreased in frequency. • Conduct an assessment of impact on clients. • Prepare and send a report to the EHNRI Management for review and approval. • Set a time frame for reduction, replacement and/or removal of the test. • Make changes known to users.

Monitor ing Test Utilization

To monitor the test ordering practices and patterns of clinicians and healthcare providers, the Laboratory Management shall follow these guidelines:

To determine the top problematic test(s) in each area: • Obtain divisional and site reports from Laboratory Informatics Group (LIG) on

TITLE: Laboratory Test Utilization Revision Date: Document Number : OP- 6.1.5 Status: Section: Process Control – Pre-Analytical Page: 2 of 3


a quarterly basis • Compare previous quarterly report for any significant increase/decrease in test

orders. • Contact the appropriate physician group(s) and inform them of the findings. • Address any problems that may be caused by the increase, decrease, or removal

of a test. • Work with the Laboratory Informatics Group (LIG) to establish rules and

guidelines for rejection of duplicate specimen requests. • The Quality Officer will Include and/or update rules and guidelines in the

laboratory’s Specimen Rejection Policy. • Prepare a report and send to those concerned.

NOTE: It is noted that for each introduction, replacement or removal of a laboratory test, extensive revision of quality management documents, timely notification of laboratory users and LIS involvement is required.

Responsibility Director General • Reviews and approves the policy

• Allocates and approves resources Directorate Directors and Team Leaders • Approve the introduction, replacement or removal of

laboratory tests • Notify clinicians and other health care providers of changes

to the laboratory test menu • Provide reports and documentation for the introduction,

replacement or removal of laboratory tests • Determine problematic tests • Liaison with LIG to create rules to reject duplicate specimen

testing • Contacts physicians to obtain input on ordering practices • Assesses and justifies the addition, replacement or removal of

tests to the laboratory menu

Quality Officer • Reviews and revises related operational policies when additions or changes to LIS Rules occur

Laboratory Informatics Group • Manipulates LIS database to accommodate test addition, replacement or removal requests

• Creates Rules for rejection of duplicate specimen requests • Provides statistics and data by developing appropriate LIS

programs

TITLE: Laboratory Test Utilization Revision Date: Document Number : OP- 6.1.5 Status: Section: Process Control – Pre-Analytical Page: 3 of 3



Document Name Document # Document Location Physician’s Laboratory Handbook (Test Menu) pending

Refer ences

Rubin, B, Pfaller, M, Kemp, J. Strategies to Affect Laboratory Utilization, Laboratory Medicine, Sept 2002 Model Compliance Plan for Clinical Laboratories, Federal Register, Vol 63, No.163, August 1998


TITLE: Retention Dir ectives for Diagnostic Mater ials Revision Date: Document Number : OP-6.1.6 Status: Draft Section: Process Control Page: 1 of 4


Purpose

To provide guidance for the retention of diagnostic material.

Policy Diagnostic materials are retained to ensure there is an audit trail for review, confirmation of specimen integrity or identity and to allow additional testing to be done on the original specimen once the report is received by the requesting practitioner. EHNRI is committed to effective diagnostic materials management that meets standards for retention, protection of privacy, confidentiality, maintenance, optimization of space and disposal at the proper time. Supporting statements Retention Time Per iods Retention time periods are established for all diagnostic material that comply with

accreditation and regulatory requirements.

Retention Guidelines 1. Overall implications of retention and disposal of diagnostic material are considered within legal, ethical and research frameworks.

2. Retention guidelines represent the minimum standards for retention diagnostic

material. Laboratories may choose to exceed these minimum requirements based on availability of space and other clinical factors.

Storage Requirements Materials are stored in a suitable environment to prevent loss, unauthorized access, damage or deterioration due to the effects of factors such as temperature fluctuation, water or fire.

Retention Limitations 1. It is recognized that it may not be possible to retain certain specimens and that in some procedures all of the material collected may be consumed during the testing.

2. Appropriate aliquots or prepared material may be retained in lieu of the entire

original specimen. Medico-legal requirements

Specimens collected for medico-legal purposes may have separately specified retention requirements

Retention Times:

TITLE Retention Directives for Diagnostic Mater ials Revision Date:

Document Number : OP-6.1.6 Status: Draft Section: Documents and Records Page: 2 of 4


The following minimum requirements meet or exceed those recommended by professional and regulatory standards. Section 1 includes all general pathology specimens. See sections 2 – 9 for specific discipline records and specimens having different retention periods or special requirements.

1.0 CLINICAL CHEMISTRY

MATERIAL MINIMUM DURATION OF RETENTION

1.1 Urine Specimens 1.1.1 Aliquots of 24-hr urine (2-8°C) Until testing completed + 2 days 1.1.2 Routine urinalysis Discard after specimen verified 1.1.3 Urine for pregnancy testing 2 days

1.2 Blood gas results generated from instruments 5 year

not interfaced and require manual LIS input

1.3 Routine serum/plasma (2-8°C) 2 days

1.4 CSF and body fluids (2-8°C) 2 days

1.5 Instrument calibration Records 1 year + current year

2.0 HEMATOLOGY MATERIAL MINIMUM DURATION OF RETENTION

2.1 Blood Specimens

2.1.1 Coagulation (2-8°C) 2 days 2.1.2 EDTA bloods (2-8°C or RT) 2 days

2.2 Bone Marrow Reports 20 years 2.3 Bone Marrow Slides 20 years

2.4 Peripheral Blood Smear

2.4.1 Abnormal (room temperature) 1 year 2.4.2 Normal (room temperature) 7 days

2.5 Special Test Booking Dates 1 year

3.0 MICROBIOLOGY RECORD/MATERIAL MINIMUM DURATION OF RETENTION

3.1 Original Specimen

3.1.1 Blood culture vials After final activity report (FAR) checked 3.1.2 Non-sterile specimen (RT) Discard according to SOP 3.1.3 Plates with growth or no visible growth (RT) After FAR checked 3.1.4 SAF stools (RT) 2 weeks after final report




3.1.5 Skin scrapings (RT) 3 weeks 3.1.6 Sterile fluids, referred-in identification 2 weeks

specimens, blood transfusion specimens (4°C) 3.1.7 TB sediments (4°C) 8 weeks 3.1.8 Tissue and CSF (-20°C) 1 month frozen

3.2 Positive Isolates

3.2.1 MSRA, VRE, ESBL, Amp C, H. influenza, 1 year S. pneumoniae, N. meningitidis (-70°C)

3.2.2 Significant isolates from blood cultures, 1 year CSF, intraocular and transfusion specimens (-70°C)

3.2.3 Enteric pathogens (RT) 1 year 3.2.4 N. gonorrhoeae (-70°C) 1 year 3.2.5 H. pylori (-70°C) 1 year 3.2.6 M. tuberculosis (-70°C) 10 years 3.2.7 Non-tuberculosis mycobacterium (-70°C) 1 year 3.2.8 Yeast isolates resistant to fluconazole 1 year

(-70°C) 3.2.9 Nocardia species (-70°C) 1 year 3.2.10 All survey and referred-in isolates (-70°C) 1 year 3.2.11 Dimorphic fungi (-70°C) 1 year 3.2.12 Mycology isolates-genus level (RT) 1 month 3.2.13 Mycology isolates-speciated (RT) after FAR’s are checked

3.3 Virology

3.3.1 Original tissue (-70°C) 1 month 3.3.2 Routine specimen (4°C) 2 weeks after final report 3.3.3 Positive specimen 1 year 3.3.4 Positive isolates and 1 year

1st

3.3.5 Slides (RT) 1 week after final report positive passage (-70°C)

3.4 Immunology

3.4.1 Original specimen/whole blood (4°C) 1 week after final report 3.4.2 Aliquot (4°C) 2 weeks after final report

4.0 TRANSFUSION SERVICE

MATERIAL MINIMUM DURATION OF RETENTION

9.6 Blood Specimens 9.6.1 Routine specimens 14 days 9.6.2 Pre-admission specimens 30 days




Responsibility

Directorate Directors and Team Leaders • Establish and periodically review retention directives. • Ensure adequate and appropriate storage space is

available. Quality Officer • Ensures policies and procedures are in compliance with

regulations and standards. Laboratory Staff • Retains specimens according to established processes.

• Prepares suitable specimen aliquots for storage.


Document Name Document # Document Location

Refer ences

College of American Pathologists, Laboratory Accreditation Newsletter. March 2001 National Pathology Accreditation Advisory Council, Retention of Laboratory Records and Diagnostic Material, 3rd Edition, 2002. Ontario Association of Medical Laboratories, Guidelines for the Retention of Laboratory Records & Materials, CLP020-001, Revised June 2006. Canadian Society of Cytology, Guidelines for Practice and Quality Assurance in Cytopathology, 3rd Revision, January 2005. Canadian Association of Pathologists, The Retention and Use of Human Biologic Materials, November, 2005. Canadian Standards Association, Z902-04 Blood and Blood Components, Mississauga, Ont. March 2004. Nova Scotia Association of Clinical Laboratory Managers, Retention of Laboratory Records and Diagnostic Material, November 2007



TITLE: Technical Procedures (SOPs) Revision Date: Document Number: OP-6.2.1 Status: Draft Section: Process Control - Analytical Page: 1 of 7


Purpose

To establish a uniform process for the development, implementation and review of technical procedures for EHNRI. Policy

Technical procedures, also known as standard operating procedures (SOPs), are written documents that describe methods or techniques in sufficient detail to ensure the quality, reliability and integrity of test results. EHNRI shall have a written documents for each technical procedure performed in the laboratory. Technical procedures, an integral and critical part of the EHNRI’s quality system, shall be used to:

• Improve quality by ensuring consistent, repeatable activities. • Facilitate training by providing technical staff with references for specific tasks. • Comply with standards by implementing checklists for training, audits and inspections. • Reduce safety risks and other hazards by specifying how to avoid and prevent them. • Evaluate technical operations by reviewing procedures for relevancy and adequacy.

Supporting statements Structure 1. All technical procedures for analytical testing performed in EHNRI are developed in

accordance with regulatory requirements based on published methods and recommended guidelines from regional, national or international organizations.

2. Technical procedures are written clearly, concisely and consistently by laboratory staff that are knowledgeable in the activity or are qualified to perform the task.

Content 1. Technical procedures must include the following information where applicable: 1.1. Purpose 1.2. Abbreviations 1.3. Materials 1.4. Sample 1.5. Special Safety Precautions 1.6. Maintenance 1.7. Calibration 1.8. Quality Control 1.9. Procedure 1.10. Calculation 1.11. Result Interpretation 1.12. Expected values 1.13. Limitations 1.14. Procedural Notes 1.15. Principle 1.16. Clinical Utility 1.17. Related Procedures and Documents 1.18. References 1.19. Appendixes and attachments

Guidelines for preparing technical procedures are found in Appendix 1.



2. Manufacturer’s instructions may be used as part of a written technical procedure provided any modification reflects the procedure as performed in the laboratory.

3. Associated logs or forms, specimen collection instructions or other documents related to the procedural change are developed and communicated to the appropriate health care providers.

Supporting/Reference Material

1. Technical manuals of current procedures, either in hard copy or electronic format, are readily accessible or made available to staff at workstations where the activity is performed.

2. Job aids or abridged instructions may be used at the workstation provided they correspond and refer to a technical manual or procedure and are part of the document control system.

Validation All procedures developed in-house must be validated for their intended use. Approval Each technical procedure is reviewed for accuracy and approved with the signature of

the authorizing person prior to implementation. Implementation 1. Implementation of new or revised technical procedures is communicated to all

testing personnel prior to the implementation date. 2. Each Directorate documents that testing personnel (by individual name) have

reviewed and understood the changes and have been trained as necessary. Review Process 1. Technical procedures are reviewed annually for completeness and alignment with

current practice or to determine whether the procedure is needed. 2. The Department also evaluates the effectiveness of its technical operations and

makes changes to any technical procedure, training activity or monitoring process as required.

3. EHNRI identifies potential sources of error in technical processes and procedures and takes action to mitigate occurrences when and wherever possible.

Document Management System

EHNRI has a laboratory document management system, to provide: • A master list of technical procedures currently in use. • A master file that contains the historical record of the current and all previous

versions of the document. • The removal of obsolete or retired procedures from circulation and the

identification of them as obsolete. • An archival system that maintains obsolete procedures and records for 10 years.

Client Access Clients of the EHNRI have access to analytical methods, procedures and performance specifications on request. They are advised in writing prior to the implementation of any significant changes to procedures, specifications or interpretation of test results that may impact on their practice.



Responsibility

Director General • Review, revise and approve technical procedures • Communicate significant changes to clients

Directorate Directors and Team Leaders

• Ensures operations and activities in their area have established technical procedures

• Reviews, revises and approves technical procedures • Develops documents related to procedure changes and

notifies appropriate healthcare providers Quality Officers

• Provides and maintains the technical procedure template and format

• Oversees the numbering, retention, indexing , revision and archiving of technical procedures

• Reviews draft documents for compliance with regulations, standards, manufacturers’ instructions and related policies.

Laboratory Staff • Identifies the need for development or revision of technical procedures

• Writes technical procedures as assigned • Reviews and revises technical procedures • Follows approved technical procedures


Document Name Document # Document Location Training and Initial Competency OP-3.2 Quality Manual Competency Assessment Program OP-3.3 Quality Manual Technical Procedure Template OP-4.4 Quality Manual Retention Directives for Laboratory Records and Diagnostic Materials


Review of Technical Procedure Manuals OP-8.2 Quality Manual

References

Accreditation Canada, Laboratory and Blood Bank Standards, Qmentum Program 2009, 10.1-10.9 CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 5.5.1:20, 5.5.3:20. Clinical and Laboratory Standards Institute (CLSI). Laboratory Documents: Development and Control; Approved Guideline—Fifth Edition. CLSI document GP2-A5 (ISBN 1-56238-600-X). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 2006



Appendix 1: Instructions for Using the Procedure Template

Purpose

Insert a brief description of why this document is being written. The purpose shall begin with “This procedure provides instructions…”

Abbreviations

Insert all abbreviations or acronyms used in the document. e.g. CC= Clinical chemistry Anti-TPO Ab= Antithyroid peroxidase antibody ME= Medical Examiner RT= Room Temperature

Materials

Reagents

List all reagents used to perform the procedure.

Name, manufacturer, number

Reagents preparation: Step-by-step instructions for reagent preparation. Reagents stability and storage:

Supplies Include all supplies and consumables required to perform the procedure. e.g. disposable pipettes pipette tips cotton swab test tubes

Equipment List equipment used to perform the procedure. Name, manufacturer, model

Sample

List all acceptable sample types that apply to this analyte.

Sample type Amount required Transport and Storage

Stability

Source and

Time and



container type temperature Limitations: Hemolysis, lipemia, interfering substances, etc. Sample retention: Samples are discarded after __ days.

Special Safety Precautions

Only insert additional safety requirements that are not covered by the routine lab procedures listed in the safety manual. Shall include, “Refer to Clinical Chemistry Safety Manual for standard safety procedures”. Describe use of personal protective equipment required.

Maintenance

Refer to instruction manual where possible. Should include instructions for maintenance and troubleshooting guidelines. Maintenance log sheet shall be included as appendix to the procedure. Use table if necessary

Step Action

Calibration

Calibrator Level Stability Frequency Preparation

(y/n) Name, manufacturer, number

Time and temperature

Calibrator preparation: Step-by-step instructions for calibrator preparation Note: Shall include troubleshooting required when expected results are not achieved.

Quality Control

Control Level Stability Frequency Preparation

(y/n) Name, manufacturer, number

Time and temperature

Control preparation: Step-by-step instructions for control preparation



Note: Shall include troubleshooting required when expected results are not achieved

Procedure

Step-by-step instructions which exactly describe how the procedure is done.

Step Action

Step Action

Calculation

Include any calculations required and an example of how to perform.

Result Interpretation

Procedure for reporting. Interpretation of results that will require follow up (i.e. decision and critical range including reporting procedure, dilutions of sample that exceed method limitations)

Expected Values If different sample type used, more than one table may be required.

Analyte Reference Range Toxic range

Analytical Range

Units Male Female

Limitations

If applicable include possible sources of error, interfering substances, analytical sensitivity and specificity, etc.

Procedural Notes

Any helpful information that does not fit in above categories.

Principle

Brief description of chemical reaction.



Clinical Utility

Brief description of use in diagnosis.

Related Procedures and Documents

List all documents referred to in this procedure, any documents that could require change if this document is changed. Document can be included as hyperlinks (has to be created once the document is saved in the approved documents folder). e.g.

• Clinical Chemistry Safety Manual • Routine Chemistry Downtime Procedure • Operator’s Manual • Forms • Worksheet

Reference

List all references used to create document.



TITLE: Method Validation Guidelines Revision Date: Document Number: OP-6.2.2 Status: Draft Section: Process Control - Analytical Page: 1 of 3


Purpose To provide guidelines on method validation for EHNRI.

Policy EHNRI shall use only validated methods to ensure examination processes perform according to the laboratory’s requirements or the manufacturer’s claims or, for in-house tests, according to its intended use. The validations shall be as inclusive as necessary to meet the standards in the appropriate field of application. All laboratories shall document the validation process in a report that includes the validation protocol, procedures, identification of key aspects evaluated, and provisions for interpretation, conclusion or recommendation. Supporting Statements Method Validation 1. Method validation provides evidence of the following:

1.1. Accuracy: Verification of accuracy is the process of determining that the

system is producing clinically valid patient results. This is determined by assaying materials with assigned values, comparing patient results with a method of long-standing use, verifying results from inter- laboratory survey specimens or splitting specimens with another laboratory.

1.2. Precision: An assessment of the method/instrument is conducted to ensure

that adequate precision performance is obtained. This is determined by running replicates of a specimen or quality control material over a period of time. The mean, standard deviation (SD) and coefficient of variation (CV) are then calculated from the data which is used to determine within-run SD acceptability.

1.3. Sensitivity: The manufacturer’s claimed sensitivity of the new analyte and/or

instrument is validated. This is demonstrated by using successive dilutions of a previously analyzed patient specimen or control.

1.4. Dilution Functionality: This is performed to determine the recovery of an

analyte on dilution. This validation ensures auto dilution or reduced and/or increased volume procedures that may be an integral part of the instrument function as specified by the manufacturer.

1.5. Carryover Studies: An assessment of potential carry-over from one

specimen to another is performed by following the manufacturer’s instructions and acceptability limits.

1.6. Specificity: This is the ability to deal with interfering substances. The

Department only performs interference validation in the absence of any claims by the manufacturer. This will then be verified by running specimens



spiked with hemoglobin, bilirubin or lipids or by using patient material with known conditions.

1.7. Linearity: A linearity assessment of the analyte and/or instrument is

determined to validate the manufacturer’s claims as to the analytical measuring range of the instrument. The linearity for each assay is verified by analyzing calibrators and controls of variable, known concentrations. After verification of the measurable range, the reportable range is established which represents the upper and lower limits for reporting patient values.

1.8. Reference Interval Verification: Reference intervals are obtained for the

local population as a result of differences that are encountered due to sex, age, environment and ethnicity. The choice of reference range can be from documented literature, manufacture-suggested ranges, or existing laboratory ranges or the Department may perform a full normal value study to establish its own range. If published ranges are used, they are validated by analyzing specimens from healthy non-diseased individuals. Parallel tests are also performed to confirm reference intervals for controls when changing reagents or Quality Control lot numbers.

Scheduling Validation studies are performed any time a new instrument or methodology is implemented, an existing instrument or method is changed or instruments are repaired or updated within the laboratory

Validation Process 1. A validation protocol, using the approved format, is developed that describes the number and source of the specimens to be used, the principles behind the new and reference methods being used with applicable references and the criteria for acceptance of the new method.

2. The Directorate Director or designate approve each validation protocol and summary report before patient testing is initiated.

3. Upon approval, the validation process is incorporated into a technical operating procedure with appropriate staff training and education.

4. Following the study, a validation report is prepared describing what was done, any deviation from the protocol and the summary of results with a decision as to whether the new method is acceptable.

5. Each laboratory prepares a validation discrepancy report for investigation and resolution of discrepant results or deviations from the validation protocol.

Record Retention Documentation of validation studies, including the data, is maintained according to EHNRI’s Retention Directives for Laboratory Records and Diagnostic Material policy.



Client Notification ns and other affected members of the health care team are notified when new laboratory

are implemented that may result in changes to patient management, preparation and n collection. This notification also includes a listing of substances or conditions that with the test.

Responsibility

Director General • Approves validation protocols and summary reports

• Notifies physicians and other health care members of any new laboratory services


• Develop policies, processes and procedures related to new methodologies • Approve validation protocols and summary reports • Train and educate staff • Notify physicians and other health care members of any new laboratory

services • Ensure Divisional and Site methodologies and instruments are validated • Establish performance acceptability and reference range criteria

Quality Officers • Develop method validation protocols • Investigate and resolve discrepant results • Retain appropriate documents and data

Laboratory Staff • Participates in the validation process as assigned


Document Name Document # Document Location Method Validation Process OP-8.8 Quality Manual Validation Protocol Template OP-8.9 Quality Manual Validation Discrepancy Report Template OP-8.10 Quality Manual Retention Directives for Laboratory Records and Diagnostic materials


Linearity Procedure pending Precision Procedure pending Method Comparison pending

References Ontario Laboratory Accreditation (OLA) Requirements, Version 4 December 2007, V1.2 ISO 15189:2007(E) Medical laboratories – Particular requirements for quality and competence, 4.6.2:8, 5.5.2:20


TITLE: Reference Ranges Revision Date: Document Number: OP-6.2.3 Status: Draft Section: Process Control - Analytical Page: 1 of 3


Purpose

To provide guidelines for establishing reference ranges that meet requirements for reliability and usefulness.

Policy Reference ranges are important decision support tools used by health care providers in the interpretation of laboratory data to help define the clinical status of a patient. EHNRI shall establish and validate reference ranges that, where applicable, are reflective of our current population. Supporting statements Establishing Reference Ranges

1. Each laboratory develops reference intervals, either health-associated or decision-based, using a systematic process that takes into account the various influences on the measured laboratory test results.

2. The protocol for establishing reference ranges is to perform a reference

interval study of samples collected from a sufficient number of appropriate reference individuals to yield a minimum of 120 samples for analysis, by nonparametric means, for each partition (e.g., sex, age range).

3. The laboratories may adopt or transfer reference ranges from the

literature, manufacturers’ suggested intervals, data mining (Bhattacharya method) or other laboratories provided the analytical methods are identical and an abbreviated verification study is performed.

Review Process Reference ranges are reviewed on a regular basis, when changes have been

made to the existing method or pre-examination procedure or when there is reason to suspect the established range is no longer valid.

Client Notification EHNRI communicates any change in reference ranges to all affected health

care providers in an appropriate manner. This may be with a temporary footnote on results, memorandum to clients or other defined methods.



Process for Establishing a Reference Range: STEP PROCESS 1. Define the analyte Include a brief description of the analyte, the clinical utility,

biological variation and major variations in form. 2. Define the method Include a description of the method used, the accuracy base,

analytical specificity and, if possible, evidence that the assay is working as specified by the manufacturer and remains stable over time.

3. Define pre-analytical factors Document any important pre-analytical considerations together with any actions taken in response to the interference.

4. Define the principle Document the principle behind the reference interval (i.e. 95% confidence limit) and make available to clients if required.

5. Describe the data sources Document the data sources including number of subjects, nature of subjects (how defined), important exclusions, relevant pre-analytical factors, statistical measures, outliers excluded, analytical method and traceability of method.

6. Define partitioning Document considerations of partitioning based on sex and age etc. including when partitioning is not performed.

7. Define number of significant figures

State the degree of rounding of the reference range limits with the reasons for the conclusions.

8. Define clinical significance Confirm the validity of the proposed reference range with clinical clients. Record the people involved in the decision-making process and engage them again in any re-consideration of the interval at a later time.

9. Decision and implementation Document the factors used to determine the final decision on the upper and lower reference limits. Describe the process of communicating the change to clients.

Responsibility

Director General • Review, revise and approve reference ranges

• Collaborate with Medical Staff to ensure validity of ranges • Communicate to clients any changes to reference intervals


• Develops protocols for determining reference ranges • Documents and records data used in validation studies • Prepares report on reference range process

Laboratory Staff • Assists in study as assigned • Analyzes specimens and collates data




Document Name Document # Document Location Reference Ranges – All Labs pending

References

NCCLS. How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline—Second Edition. NCCLS document C28-A2 ,Wayne, Pennsylvania USA 2000. Jones, G., Barker, A., Reference Intervals. Clinical Biochemist Reviews, August 2008: 29 (Supplement (i)): S93-S97.


TITLE: Critical Results Reporting Revision Date: Document Number : OP-6.3.1 Status: Draft Section: Process Control – Post-Analytical Page: Page 1 of 2


Purpose To outline the requirements for the timely reporting and notification of critical results. Policy

A critical test result is urgent information that will likely affect patient health or treatment. EHNRI shall ensure that all critical results are confirmed and communicated, without error, to those responsible for the care of the affected patient in a time-frame that is reasonable for proper diagnosis and treatment. Definitions Critical Test: A laboratory test of crucial importance to a decision affecting immediate patient care, whether the results are normal or abnormal. Critical Value: A laboratory test result that indicates a life-threatening condition requiring urgent medical intervention.

Supporting Statements Critical Test Values Critical test values are defined by the policies of each laboratory division

and are posted for individual tests in the technical manuals. Reporting Critical Values

1. EHNRI immediately communicates all critical results, including those determined by reference laboratories, to clinical personnel responsible for patient care.

2. To verify accuracy, all critical test values given verbally to the healthcare

provider must be read-back by the recipient to the laboratory person making the call.

3. All critical laboratory results must be called to the physician or patient

care area unless otherwise directed by laboratory policy. In the event that a critical value is not called, a comment must be made in the LIS system indicating the reason why the critical result was not called.

4. Each laboratory will implement a defined process outlining procedures

for the reporting and documenting of critical results. A contingency plan, detailing the sequence of notification, is followed in the event the attending physician is unavailable. The on-call Divisional physician is notified and determines the significance of the result and whether further action is required.

TITLE: Critical Results Reporting Revision Date: Document Number : OP-6.3.1 Status: Draft Section: Process Control – Post-Analytical Page: Page 2 of 2


5. A Patient Safety Report must be completed for each occurrence when a

physician or patient care area cannot be reached.

Process Improvement Each laboratory conducts critical result audits to determine if a need for improvement exists in the timeliness of critical result reporting. When identified, appropriate action plans will be implemented, monitored and measured for effectiveness

Responsibility Director General • Collaborate with medical staff to define critical values

• Review and revise related policies, processes and procedures Directorate Director and Team Leader

• Ensures processes and procedures are in place for critical result reporting

• Reviews and revises related policies, processes and procedures • Conducts periodic audits on critical result reporting

Quality Officer • Ensures compliance with policies, standards • Monitors quality indicators and works with Team Leader and staff on

process improvement. Laboratory Staff • Report all critical results to physician/patient care area as quickly as

possible • Document communication of critical results in LIS • Notify the appropriate laboratory physician if problems are

encountered with the reporting of critical results • Maintain confidentially of patient data

Supporting Documents Document Name Document # Document Location Release of Laboratory Report pending Critical Results Procedure, Chemistry pending Critical Results Procedure, Hematology pending Critical Laboratory Values pending

References

Laboratory Documents: Development and Control: Approved Guidelines – Fifth Edition. CLSI document GP2-A5 March 2006; 9.3:17; 9.3.3:19. Application of a Quality management System Model for Laboratory Services: Approved Guideline – Third Edition. NCCLS document GP26-A3 November 2004: 5.3.1:12.


TITLE: Critical Values Revision Date: Document Number : OP-6.3.2 Status: Draft Section: Process Control – Post-Analytical Page: 1 of 2


Purpose

To identify and develop a listing of critical values for laboratory tests.

Policy

EHNRI shall establish a list of critical values that is used by laboratory personnel to decide when to notify physicians and other health care providers of potentially life-threatening medical situations. Definitions Critical Test: a laboratory test critical to patient care decisions whether the results are normal or abnormal Critical Value: a laboratory test result that indicates a life-threatening condition that may be corrected by appropriate and timely intervention Critical (Irretrievable) Specimen: a specimen that is difficult or impossible to retrieve or repeat

Supporting statements Critical Value Cr iter ia Critical value criteria are defined by EHNRI in conjunction with the Medical

Staff. A list of critical tests, critical values and critical specimens is found in Appendix 1, 2 and 3.

Notification Processes and procedures are in place for immediate notification of critical

results to appropriate health care providers when results fall within the established critical ranges.

Review EHNRI annually reviews the listing of critical tests, critical values and critical

specimens and makes appropriate changes when required.

Responsibility

Directorate Directors and Team Leaders • Work with Medical Staff to develop critical listings • Review and revise critical listings on a regular basis • Ensure staff are trained in critical result communication

process • Enforce policies and procedures

Quality Officer • Ensures compliance with policies, standards • Monitors quality indicators and works with Team Leader and

staff on process improvement.

TITLE: Critical Values Revision Date: Document Number : OP-6.3.2 Status: Draft Section: Process Control – Post-Analytical Page: 2 of 2



Document Name Document # Document Location Critical Results Reporting 6.3.1 Quality Manual – Volume 2

References

CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 5.8.7:24; 5.8.8:24. NCCLS. Application of a QualityManagement SystemModel for Laboratory Services; Approved Guideline – Third Edition. NCCLS document GP26-A3 November 2004;5.3.2:12


TITLE: Discrepant and Corrected Results Revision Date: Document Number : OP-6.3.3 Status: Draft Section: Process Control – Post-Analytical Page: 1 of 2


Purpose

To outline the requirements for the management of discrepant and corrected results

Policy

EHNRI shall ensure all discrepant test results are investigated for clarification and resolution and that the appropriate healthcare provider is notified of any amended or corrected report. Definition Discrepant Result: A result that is significantly different when repeated or a difference in interpretation that may impact patient care.

Supporting statements Managing Discrepant / Corrected Results

EHNRI has processes in place to correlate differing results of related examinations, to correct erroneous results and to investigate concerns from physicians on the validity of reported test results.

Traceability of Corrected Results

1. Reports that display “corrected” results clearly indicate that the new result is replacing a previously reported incorrect result.

2. Computer records allow for the retention of the original and corrected entry with

both becoming part of the permanent patient record. Results that have been available for clinical management decisions are retained in subsequent cumulative reports and are clearly identified as having been revised.

3. When corrections are made to reported results, the laboratory record indicates the

date, time (if appropriate) and the identity of the person who made the change. Notification of Corrected Results

The appropriate healthcare personnel are informed of the correction and the laboratory record indicates the identity of the person making the call and the identity of the person receiving the corrected results.

TITLE: Discrepant and Corrected Results Revision Date: Document Number : OP-6.3.3 Status: Draft Section: Process Control – Post-Analytical Page: 2 of 2


Responsibility


• Work with Medical Staff to develop a process for communication of discrepant and corrected results

• Review and revise discrepant and corrective result on a regular basis • Ensure staff are trained in discrepant and corrective result communication

process Quality Officer • Ensures compliance with policies, standards


Laboratory Staff • Communicate the need to correct results to the Team Leaders quickly as possible

• Document corrected results and actions taken • Notify the appropriate laboratory physician if problems are encountered

with the reporting of corrective results • Maintain confidentially of patient data • Fill out NCE report


Document Name Document # Document Location Final Report OP – 6.3.4 Quality Manual Retention Directives for Laboratory Records and Diagnostic Materials


References

CAN/CSA – Z15189-03 Medical laboratory particular requirements for quality and competence, 5.8.15-16

Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition. NCCLS document GP26-A3 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.



TITLE: Final Report Revision Date: Document Number : OP-6.3.4 Status: Draft Section: Process Control – Post-Analytical Page: Page 1 of 2


Purpose To outline the required format and content of the final report. Policy EHNRI shall ensure that the final report contains all necessary patient identification, laboratory and testing information in a legible, interpretable and accurate manner and is readily available to those involved in the care of the patient.

Supporting Statements Final Repor t For mat 1. EHNRI collaborates with users of laboratory services to develop standardized

patient report formats. 2. The final report uses language, syntax and nomenclature as recommended by

international, national or professional organizations. 3. The final report includes:

3.1. The name and address of the Institute and the laboratory where the tests were performed.

3.2. The name, billing number and unique LIS generated number for the patient. 3.3. The type of specimen and interpretation of the test. 3.4. Comments on quality of the specimen, if the condition of the sample

compromises the result. 3.5. The collection date and time of the specimen. 3.6. The date and time of the release of the report. 3.7. A clear identification of the examination performed; the results with

designated units of measure and reference intervals and limitation remarks. 3.8. An interpretation of results, if appropriate. 3.9. The signature of a designated Laboratory Supervisor who is authorized to

release the final report. Repor t Review The content and format of all generated patient reports is reviewed, revised, if

required, and approved by the Director on a regular basis.

Generating Repor t A final report is generated when the last of the requested work is completed and is distributed to the ordering physician either printed hard cop, electronically, by standard mail or fax.

Recor d Retention Final reports are maintained by EHNRI as outlined in Section 1.10 of the Retention

Directives for Laboratory Records and Diagnostic Materials policy.

TITLE: Final Report Revision Date: Document Number : OP-6.3.4 Status: Draft Section: Process Control – Post-Analytical Page: Page 2 of 2


Responsibility

Director General • Reviews and approves policy Directorate Director • Reviews and revises policy

• Authorizes the release of all final reports • Collaborates with laboratory users to develop final report

format • Ensures documentation is complete to release final report

directly to patients Team Leader • Quality Officer • Ensures compliance with policies, standards


Laboratory Information System (LIS) Database Coordinators

• Build new or make changes to the existing final report format


Document Name Document # Document Location Retention Directives for Laboratory Records OP-4.6 Quality Manual Release of Laboratory Report pending Quality Manual

Refer ences

Application of a Quality Management System Model for Laboratory Services; Approved Guidelines – Third Edition. NCCLS document GP26-A3 November 2004; 5.3.2:12. CAN/CSA-Z15189-03 Medical Laboratories- Particular Requirements for Quality and Competence; 5.8.3:22; 5.8.5:24; 5.4.7:19; 5.8.4:23; 5.8.13:24; 5.8.2:22; 5.8.9:24; Annex B.5.4:30.


TITLE: Internal Quality Control Program Revision Date: Document Number: OP-7.1 Status: Draft Section: Quality Assurance Page: 1 of 3


Purpose

To design internal quality control systems (IQC) which verify the attainment of the intended quality of results.

Policy EHNRI shall implement and use internal quality control programs designed to detect analytical errors that can invalidate the reliability of patient care results. Established IQC processes, including Westgard rules, biological variation limits, Levey-Jennings charts, and statistical methods for interpretation are used to monitor the analytical quality of the testing examination. Patient results are only released when EHNRI ensures that results are correct and Quality Control (QC) levels are within range. Supporting Statements Target values

Acceptable quality control limits and ranges for each examination shall be established using repetitive testing with statistical measurement. Clear target values for the mean of each new lot number of control material shall be determined by the laboratory and specified in the SOP. Manufacturer’s stated values for controls shall be used only as guides.

Target values shall be established for each new lot number prior to use. New lots of quality control material must be analyzed for each analyte in parallel with the control material in current use to determine laboratory established target values.

QC rules Quality control (QC) rules shall be applied before reporting patient data. Decisions shall be made by inspecting and charting QC results on a written/graphic record, or a computerized system can be used to determine acceptability. QC rules and acceptance criteria shall be established for each test procedure and specified in the divisional SOP. Internal QC rules shall be designed to detect random and systematic error. Multiple QC rules shall be used to decrease the probability of false rejection.

Corrective action is required when QC results fall outside defined expectations and shall be included in SOPs.

Qualitative tests A positive and negative control shall be run according to the manufacturer’s instructions and/or at minimum weekly. For tests that are batched and performed only periodically, positive and negative controls shall be run as the test procedure is used.

Quantitative tests The number and concentration of quality control specimens shall be sufficient to determine proper operation over the range of interest. The concentrations of analyte shall be focused at clinically relevant levels.



Quality control samples shall be analysed at least once within each user-defined

analytical run. See discipline/instrument specific standard operating procedures (SOP) for definition of user-defined analytical run.

Control of Reagents Processes shall be in place to assure that all reagents used, whether purchased or

prepared by the laboratory, are appropriately controlled. There shall be documentation that new reagent lots and shipments are checked against prior lots or known standards before or concurrent with being placed in service.

QC Tracking Mechanisms

Levey-Jennings charts or other QC tracking mechanisms shall include or refer to logs that contain the following information, as appropriate:

• Time scale based on number of runs • Full range of control limits indicated as grid lines at +/- 1, 2, and 3 Standard

Deviations (SD) (mean and SD lines identified with their concentrations) • Analyte name, • Identification of instrument/method, • Identification of QC material and level, • Lot number(s) and expiry date(s) of QC material, • Reagent and calibrator lot numbers, • Date of each data point, • Record of corrective actions, • Identification of the technologist performing and assessing QC.

Corrective Action Processes and procedure(s) for QC rule violation shall be defined for each laboratory discipline. This shall include, but are not exclusive to:

• Criteria for rejecting a run, • Method-specific troubleshooting or corrective action guidelines, • Criteria for the acceptance of patient data from runds wherein a statistical rule

may have been violated.

Definitions and Abbreviations

QC – Quality control SOP – Standard Operating Procedures



Responsibility Director General • Reviews and approves IQC policies

• Ensure IQC programs are in place Directorate Directors • Review and approve discipline specific QC policies, processes and

procedures • Review monthly QC reports and initiate corrective action plans as

appropriate Team Leaders • Review monthly QC reports and initiate corrective action plans as

appropriate • Develop and assign QC rules • Establish total QC strategies • Ensures staff are trained in QC procedures

Quality Officers • Validates all QC material before usage • Trains staff in QC procedures • Reviews QC results on a periodic basis • Performs advanced QC troubleshooting • Reviews and revises QC policies, processes and procedures • Prepares QC reports for management review

Laboratory Staff • Adhere to IQA policies, processes and procedures • Analyze the IQA material • Troubleshoots failed QC results • Inform technical specialist or designate of problem QC issues • Review and revise QC policies, processes and procedures

Supporting Documents Document Title Document # Document Location Process Control Policy QP-1.2.5 Quality Manual

Shipment Acceptance (Supply Verification) Policy

pending

Shipment Acceptance Process pending

References

ISO 15189:2003 - Medical laboratories: particular requirements for quality and competence


TITLE: External Quality Assessment Program Revision Date: Document Number: OP-7.2 Status: Draft Section: Quality Assurance Page: 1 of 4


Purpose

To provide guidelines for selecting appropriate external quality assessment (EQA) programs that encompass the extent and complexity of services provided. Policy EHNRI participates in EQA programs, including independent and inter-laboratory assessments, to safeguard and improve the quality of patient care. EQA assesses EHNRI’s performance against established standards to ensure the highest quality of laboratory services is provided to our users and patients. EHNRI also uses EQA as an educational tool to appraise and benchmark performance as well as to monitor improvement. Supporting Statements

Types of proficiency samples Suitable reference material must be used, if available, from approved EQA providers (see Appendix 1). Reference materials shall have a similar matrix to the patient sample. When an EQA provider is not available, the Director or designate shall develop a mechanism for determining testing proficiency

Frequency of use

The frequency of the program shall be determined by the EQA provider(s) and at least annually

Processing of EQA Samples EQA samples shall be treated as much as possible in the same manner as patient samples (i.e. run the same number of times that patient samples are routinely tested). EQA testing shall be rotated among laboratory personnel.

EQA Tracking Mechanisms

Each laboratory shall document and record results from EQA programs by using the External Quality Assessment (EQA) Management Form. EQA results are initially assessed by the quality assurance designate in each laboratory to determine acceptability and to initiate corrective action, if required.

Communication of results Results must be communicated to all management and laboratory staff within two weeks of receipt. Each step of the communication and review process must be documented

Acceptance Criteria Laboratories must meet the proficiency acceptance criteria required by the EQA provider.

Remedial/Corrective/Preventive Action

The laboratory shall act upon and document problems or deficiencies identified by EQA programs by completing a



Nonconforming Laboratory Event (NCE) report. These records are retained according to the Retention Directives for Laboratory Records and Diagnostic Material policy.

Test Process • Receipt by divisional Quality Assurance Technologist or Technical Specialist, as appropriate.

• Visual inspection of proficiency material(s). • Proficiency test (PT) accessioning. • Distribution of samples to appropriate test area for processing

and workup. • Test results entered in LIS and final chart printed by the Quality

Assurance technologist, Technical Specialist, as appropriate • PT results reported to EQA provider.

Process for follow-up on unacceptable results

• PT report received by divisional Team Leader or Quality Officer, as appropriate.

• Report reviewed by Team Leader or Quality Officer, as appropriate.

• Root cause analysis performed and corrective action taken, as appropriate.

• Results and corrective action are reviewed by Director or designate and communicated to management and laboratory staff.

• Deficiencies identified by root cause analysis and corrective action(s) shall be reviewed by EHNRI and additional recommendations made, as appropriate.

• Deficiencies and corrective actions shall be communicated to the Director, Team Leaders, and laboratories involved.

Definitions EQA – External quality assurance PT – Proficiency testing



Responsibility Director General • Reviews and approves EQA policies Directorate Directors • Ensure the development and implementation of EQA programs

• Reviews EQA results and communicates to staff Team Leaders • Reviews external quality assessment results and the corrective action taken

as a result of the root cause analysis • Develops, reviews and revises EQA policies, processes and procedures • Prepare EQA reports for the Institute

Quality Officers • Accession EQA Material • Distribute EQA material for processing • Collate and return results to the EQA provider • Review returned EQA results • Establish appropriate remedial and corrective action plans for unacceptable

EQA results • Prepare EQA reports for the Quality Council • Develop, review and revise EQA policies, processes and procedures

Laboratory Staff • Adhere to EQA policies, processes and procedures • Analyze the EQA material • Give EQA results to the technical specialists for review and collation


Document Name Document # Document Location Process Control Policy QP-1.2.5 Quality Manual Nonconforming Laboratory Events OP-8.2.1 Quality Manual External Quality Assessment (EQA) Management Form

pending

Process for Managing External Quality Assessment Programs


Retention Directives for Laboratory Records and Diagnostic Material


References

Clinical and Laboratory Standards Institute. Management of Nonconforming Laboratory Events; Proposed Guideline (GP32-P), 2007; 27(13).

Capital District Health Laboratories Quality Management Self-Assessment Check-list 2005. CAN/CSA-Z15189-03Medical Laboratories-Particular Requirements for Quality and Competence; 5.6.4



Appendix 1 External Quality Assessment Service Providers Anatomical

Pathology Blood

Transfusion Chemistry Hematology Microbiology Community

Labs

AccuTrak Centre (Benchmarking) •

Beckman Instruments (Benchmarking) •

Bio-Rad Laboratories • •

Canadian Immunohistochemistry Survey • • • Immunology

Cancer Centre Prevention Program Cytology

CALA Environmental

CMPT Environmental •

CAP • • • • • •

Health Metrx Canada •

Interlaboratory Quality Assurance Program (Benchmarking) •

Laboratoire de Santé Publique du Québec Malaria Slides Malaria Slides

National Laboratory for HIV Immunology Flow Cytometry

•

National Laboratory for HIV Reference Services HIV Virology

National Microbiology Laboratory Vir/Mol

NRCM •

NWRI Environmental

Ontario Ministry Her2 QA program •

Public Health Agency of Canada Molecular

QMP-LS Flow Cytometry •

St. Joseph's Healthcare Charlton Campus Molecular

Tech Chek • •

UCLA International HLA DNA Exchange HLA

UK NEQAS Toxicology

Viral EQA (NML) •

Viral EQA (CDC) •


TITLE: Planning and Selection of Quality Control Rules and Procedures

Revision Date:

Document Number : OP-7.3 Status: Draft Section: Quality Assurance Page: 1 of 5


Purpose

To provide guidance related to the planning and selection of quality control (QC) rules and procedures for quantitative laboratory tests.

Policy

EHNRI shall establish, adhere to and continually review quality control of assays to ensure the quality of patient results. Definitions Accuracy: Trueness or closeness of the agreement between the result of a measurement and a true value. Analytical Run: An interval (usually a period of time or series of measurements) within which the accuracy and precision of the measuring system is expected to be stable. Bias: The difference between the expectation of the test results and the accepted reference values. Imprecision: Random dispersion of a set of replicate measurements or obtained values characterized by standard deviation or coefficient of variation. Measurement procedure: Set of operations specifically described with the object of determining a value of a quantity (equivalent terms include assay and method). Normalized OPSpecs Charts: Charts used to show the relationship between the quality required for a test and the imprecision and accuracy observed for a method. Precision: The closeness of agreement (reproducibility) between independent measurement results obtained under specified conditions. Sigma-metrics QC Selection Graphs: Graphs used to show the probability for rejection on the y-axis and the critical systematic error on the x-axis. Total Allowable Error: An analytical quality requirement that sets a limit for the imprecision (random error) and bias (systematic error) that is tolerable in a single measurement or single test result. Total Quality Control Strategy: A formulated plan to evaluate statistical and non-statistical components to identify factors whose residual risks are monitored by appropriate quality control measures.


Revision Date:



Supporting Statements Quality Requirements Laboratories define quality requirements for each laboratory test; when applicable,

specifications are based on total allowable error (TEa), medical applications and biological variation

Precision and Accuracy

The laboratory assesses and monitors the precision and accuracy of the measurement procedure to ensure the acceptability of the test for its intended use and that it meets manufacturers’ claims.

Quality Control (QC) Procedures

The laboratory designs and selects quality control procedures (control rules, number and frequency of control measurements) that have high error detection and low false positive rejection rates, by using graphic tools such as Sigma-metrics QC Selections graphs and Normalized OPSpecs charts to describe how to:

• Determine the amount of analytical error allowed without compromising the TEa. • Evaluate the precision and bias of the method. • Determine the size of medically significant errors. • Establish performance targets for bias, imprecision and total error • Determine the length of an analytical run • Determine the number of control measurements in an analytical run. • Establish control limits • Respond to out-of-control situations with appropriate troubleshooting guidelines.

Total Quality Control Strategy (TQC)

A total quality control (TQC) strategy is formulated to ensure the desired quality of analytical testing is obtained during routine operation. TQC incorporates statistical QC (SQC) such as control rules, number and frequency of control measurements and non-statistical components such as preventive maintenance, instrument function checks, performance validation data and patient data checks.

QC Rules Review EHNRI reviews and evaluates QC rules and procedures at regular intervals for effectiveness and initiates changes when appropriate. Indicators, including run rejection rate, bias, imprecision scores and frequency of calibrations may be used to monitor this process.

Five Quality Components

The five quality components of planning, teamwork, monitoring, review and improvement are used throughout the planning and selection process to ensure maximum quality of laboratory testing. (Appendix 1)


Revision Date:



Responsibility Director General • Reviews and approves quality policies

• Allocate and approve resources Directorate Directors • Define the quality requirements for each laboratory test

• Approve policies and processes for selecting QC rules and procedures for quantitative assays

• Use appropriate selection tools to determine QC rules and numbers of control measurements for each test

• Establish and review TQC strategies • Ensures the quality requirements for each laboratory test is defined

Team Leader/Quality Officers

• Ensures staff are knowledgeable in the QC procedure selection • Monitor the TQC strategies • Uses appropriate selection tools to determine QC rules and numbers of

control measurements for each test • Establishes and reviews TQC strategies • Implement quality improvement by identifying changes in imprecision

and inaccuracy Laboratory Staff • Determine the precision and accuracy of the method

• Monitor the daily QC activities and notify Team Leader/Quality Officers of changes in precision and accuracy


Document Name Document # Document Location Process Control Policy QP-1.2.5 Quality Manual Internal Quality Control Program OP-7.1 Quality Manual Establishing Target Values for Quality Control OP-7.4 Quality Manual Continuous Quality Improvement OP-8.1.1 Quality Manual


Revision Date:



Refer ences NCCLS. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second edition. NCCLS document EP5-A2 (ISBN 1-56238-542-9). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA 2004. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition. NCCLS document EP9-A2 (ISBN 1-56238-472-4). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2002. Clinical and Laboratory Standards Institute (CLSI). Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006. Westgard, J.O., Assuring the Right Quality Right Good Laboratory Practices for Verifying the Attainment of the Intended Quality of Test Results, 1st ed. Madison (WI): Westgard QC, Inc. 2007 Cooper, G., Gillions, T., Producing Reliable Results in the Medical Laboratory – Using a Quality System Approach and ISO 15189 to Assure the Quality of Laboratory Examination Procedures, 1st ed. Irvine (CA): Bio-Rad Laboratories, 2007


Revision Date:



APPENDIX 1: Process for planning and selecting QC rules and procedures

Q

Q

Q Planning: Define quality requirements

Monitoring: Measure QC indicators

Q Q

Q

Teamwork: Design TQC strategies

Improvement: Initiate changes when needed

Quality Goal: QC Rules/Procedures

Review: Assess QC data/records


TITLE: Establishing Target Values for Quality Control

Revision Date:

Document Number: OP-7.4 Status: Draft Section: Quality Assurance Page: 1 of 2


Purpose

To provide guidelines for establishing expected values and limits for quality control (QC) material for quantitative tests.

Policy

EHNRI shall calculate the means and standard deviations for acceptable QC performance for each lot number of control material in a test and monitor the values as part of the QC Planning. Supporting Statements Values and Limits 1. EHNRI establishes expected values and limits for each lot number of control

material prior to use, by repetitive parallel testing with a validated control sample currently in use. Published values are used for informational purposes only.

2. Values and limits are calculated from results collected over a specified period of

time to include variations that affect test performance such as maintenance, calibration, reagent lots and operator techniques. The recommendation is to use 20 results obtained on separate days, then calculating the cumulative values every 20 results until the cumulative values reflect 100 results.

3.The established values for each test are monitored at regular intervals for

relevance and effectiveness to ensure that changes in the test system have not altered the values. An inter-laboratory QC program is used to monitor performance characteristics when available.

4.Each laboratory establishes QC rules and procedures specific to their

requirements

TITLE: Establishing Target Values for Quality Control

Revision Date:



Responsibility Director General • Reviews and approves QC policies

• Ensures appropriate resources are available Directorate Directors and Team Leaders

• Reviews QC data • Approves QC target values and ranges

Quality Officers • Determine/calculates target values, ranges, CV, SD data from QC material

• Plan parallel testing for QC material Laboratory Staff • Analyzes QC material as assigned for statistical data

• Runs QC material in parallel testing Supporting Documents

Document Name Document # Document Location Process Control Policy QP-1.2.5 Quality Manual Internal QC Program OP-7.1 Quality Manual Planning and Selection of Quality Control Rules and Procedures


References

CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline – Third Edition, CLSI document C24-A3 June 2006;8.6.2:12.



TITLE: Documentation and Review of Quality Control Revision Date: Document Number: OP-7.5 Status: Draft Section: Quality Assurance Page: 1 of 2


Purpose

To provide guidelines for reviewing and documenting Quality Control (QC) results

Policy EHNRI shall review, evaluate and document results of QC testing for each laboratory test to determine if the analytical process meets performance specifications and if patient results may continue to be reported.


QC interpretation and evaluation

Each laboratory has defined guidelines for QC interpretation and evaluation and how to handle detected QC warnings or failures. Unacceptable QC results are investigated for trends or patterns that have occurred, or are occurring, with the measurement procedure.

Staff Training Training on QC interpretation and corrective/preventive action is provided to all staff upon hire and on a recurring basis.

QC Failure 1. QC results that fall outside established laboratory performance specifications are reviewed, verified and documented.

2. When a QC failure is identified, violated control rules are verified and a root cause investigation is initiated. The reporting of patient results is withheld until the root cause is found, corrective action has resolved the problem and the test system is brought back into operational specification.

3. A record of investigation, root cause and corrective/preventive actions is maintained according to EHNRI policy. Records on performance outliers are reviewed at regular intervals and serve as opportunities for continued improvement within EHNRI.

4. Each laboratory prepares an annual summary of quality control failures, their root causes, corrective and preventive actions taken, and indicator performance (total error, frequency of calibration, run rejection rate) observed since the last EHNRI Review. The report is used to approve and implement changes in the quality system as required.

POCT QC

All operators of a point-of-care device ensure and document that QC materials have been tested and are within specification as established by the Institute and/or the device manufacturer.

TITLE: Documentation and Review of Quality Control

Revision Date:



Responsibility

Director General • Reviews and approves QC policies

• Ensures appropriate resources and training are available Directorate Directors and Team Leaders

• Review QC data and indicator results at regular intervals • Discontinue patient testing if system is not operating within

specifications • Determine if patient results can be released or if the assay or

portion of the run needs to be repeated when QC problem resolved

• Verify long-term effectiveness of any corrective action • Deal with complaints and other inputs from clients • Prepare annual QC report

Quality Officers • Train staff on how to interpret and evaluate QC • Review unacceptable QC results • Initiate root cause analysis • Perform and document correction action • Monitor performance indicators

Laboratory Staff • Analyzes QC material as assigned for statistical data • Informs appropriate personnel of unacceptable QC results


Document Name Document # Document Location Process Control Policy QP-1.2.5 Quality Manual Internal QC Program OP-7.1 Quality Manual Planning and Selection of Quality Control Rules and Procedures


Retention Directives for Laboratory Records and Diagnostic Material


Root Cause Analysis pending Corrective and Preventive Actions pending

References

CLSI. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline – Third Edition, CLSI document C24-A3 June 2006;8.6.2:12. Cooper, g., Gillions, T.,Producing Reliable Test Results in the Mdical Laboratory, 1st Edition, Bio-Rad Laboratories, Inc., Irvine, Cal., 2007. CAN/CSA 15189:03 - Medical laboratories: particular requirements for quality and competence, 5.6.1-3.


TITLE: Process for Managing External Quality Assessment Programs

Revision Date:

Document Number : OP 7.6 Status: Draft Section: Quality Assurance Page: 1 of 2

Purpose

This process delineates the activities involved for managing external quality assessment schemes.


Document Name Document # Document Location Assessments: Internal & External QP-1.2.8 Quality Manual External QC Program OP-7.2 Quality Manual Nonconforming Laboratory Events OP-8.2.1 Quality Manual

Refer ences

ISO 15189:2007(E) Medical Laboratories-Particular Requirements for Quality and Competence; 5.6.4:22. ISO/IEC. ISO/IEC 17025:2005(E) General Requirements for the Competence of Testing and Calibration Laboratories 2005. Laboratory and Specimen Collection Centre Licensing Act, Revised Statutes of Ontario, Laboratories Regulation 682, 1990. QMP-LS. Standards of Practice Guidelines: Gynecologic Cytology. December 2000;11.7:13. CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 5.6.4:22.

TITLE: Process for Managing External Quality Assessment Programs

Revision Date:

Document Number : OP 7.6 Status: Draft Section: Quality Assurance Page: 2 of 2


Management of the External Quality Assessment Process

External Quality Assessment SERVICE PROVIDER

1. Clinical material dispatched to

EHNRI laboratory

External Quality Assessment EHNRI Laboratory

2. Clinical material received by the laboratory

3. Clinical material examined by the laboratory and the results recorded

4. Results of the examination returned to the External Quality Assessment PROVIDER

7. EHNRI laboratory’s reviews its performance in relation to the performance of all participating laboratories and takes action to remedy any problems

5. Results from all participating laboratories analyzed and a report prepared

6. Report indicating the performance of the laboratory’s results in relation to the performance of all participating laboratories sent to EHNRI laboratory


TITLE: Continuous Quality Improvement Revision Date: Document Number: OP-8.1.1 Status: Draft Section: Process Improvement Page: 1 of 5


Purpose

To ensure that EHNRI has processes that enhances effectiveness, efficiency and customer satisfaction through continuous quality improvement (CQI).

Policy

EHNRI continuously evaluates and improves the processes used to provide the highest quality laboratory services to enhance patient care. EHNRI uses team-focused planning, ongoing monitoring, improvement and review to minimize cost, redundancy and injury to achieve CQI.

Supporting statements CQI Approach EHNRI achieves CQI by using the five quality components, Quality

Planning (QP), Teamwork (QT), Monitoring (QM), Improvement (QI) and Review (QR).

CQI Strategies 1. Audits and management reviews are assessed annually to determine

compliance. When opportunities for improvement are identified, the laboratory designs a Performance Improvement Plan to determine possible solutions, implement changes, measure the results and monitor effectiveness.

2. Quality indicators are monitored that measure the Total Testing Process

(TTP) including all pre-analytical, analytical and post-analytical activities.

3. EHNRI participates in external quality assurance (EQA) proficiency

testing programs and benchmarks results to our peers in methodology and instrumentation to gather information regarding our deviation from the group mean, imprecision and trending biases. EHNRI uses appropriate corrective and preventive actions to continuously improve the level of performance. EHNRI participates in quality control (QC) and quality assurance (QA) programs, based on discipline specific requirements, to ensure the accuracy and reliability of patient results and reports. When QC and QA performance does not meet established specifications remedial actions for improvement are taken and documented including evaluations, solutions implemented and staff training.

4.External assessments are conducted as part of accreditation to assess the

service’s compliance with standards.



5.EHNRI provides opportunities with its clients through satisfaction surveys and complaint resolution processes. When feedback, from a survey or through a complaint, indicates the need for improvement, actions are taken to improve the service.

6.EHNRI encourages staff to identify system and process problem areas

and to make suggestions to improve efficiency, competency and service in those areas.

7.EHNRI regularly evaluates its ethical conduct to ensure it complies with

all regulations and standards that affect its service.

Performance Improvement Plan (PIP)

EHNRI uses a standardized performance improvement plan and various quality tools to plan, implement and monitor the effects of continuous quality improvement initiatives. This plan, based on a modified Shewhart Plan, Do, Check, Act (PDCA) cycle, demonstrates that improvement programs start with careful planning, result in effective action and return to careful planning in a continuous cycle. EHNRI uses the Performance Improvement Plan when:

• Starting a new improvement project. • Developing a new or redesigning a process, product or service • Defining a repetitive work process • Planning data collection and analysis in order to understand problems or determine root cause • Implementing any change

The Performance Improvement Plan provides a simple problem solving or project cycle visualized in a circular model consistent with the concept of continuous improvement.



F O C U S

The Performance Improvement Plan

The Nine Steps involved in the Performance Improvement Plan include: F – Find a process to improve O – Organize a team that knows the process C – Clarify the current knowledge of the process U – Uncover the root cause of variation and poor outcome S – Select the process improvement Then Plan, Do, Check and Act Plan

Plan the process improvement when an opportunity is presented Do

Do the improvement, data collection and analysis by carrying out small-scale study

Check

Check and review the results and identify the lessons learned

Act

Act by adopting, adjusting or abandoning the change and use what was learned to begin the cycle again



Responsibility Director General • Reviews and approves quality policies

• Approves new and revised CQI policies and processes • Leads the accreditation process

Directorate Directors / Team Leaders and Quality Officer

• Ensures CQI process is established and implemented • Ensure staff are knowledgeable in the CQI process • Review discordant audit results and the corrective action

taken as a result of an investigation • Review quality indicators for suitability and effectiveness • Review EQA results for non compliances and trending

shifts to improve lab performance • Resolve complaints and communicate results to clients • Ensure implementation of laboratory QC programs • Participate in accreditation activities

Laboratory Staff • Perform duties according to current policies, processes and procedures

• Perform, review and report QC and initiate corrective action when appropriate

• Act on problems and make suggestions for improvement • Monitors and measures quality indicators


Document Name Document # Document Location Process Improvement QP-1.2.9 Quality Manual Client Service and Satisfaction QP-1.2.10 Quality Manual Retention Directives for Laboratory Records and Diagnostic Material


Continuous Quality Improvement Process OP-8.1.2 Quality Manual Quality Improvement Plan Template OP-8.1.3 Quality Manual



References CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 4.1.5:4; 4.15.1:11; 4.15.2:12; 4.2.3:5; 5.1.4:13. American Society for Quality. Project Planning and Implementing Tools: The Shewhart Plan-Do-Check-Act Cycle [online]. Cited 2008 Sept 8. Available from: URL:http:/www.asq/learn-about-quality NCCLS. A Quality Management System Model for Health Care; Approved Guideline - Second Edition. NCCLS document HS1-A2 November 2004; 2.1. NCCLS. Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline -Second Edition. NCCLS document GP22-A2 November 2004;4:4-5. NCCLS. Application of a Quality Management System Model for Laboratory Services; Approved Guideline – Third Edition. NCCLS document GP26-A3 November 2004;6.2:19

http://www.asq/learn-about-quality


TITLE: Continuous Quality Improvement Process Revision Date: Document Number: OP-8.1.2 Status: Draft Section: Process Improvement Page: 1 of 2


Purpose

This process provides direction for the use of established quality management tools to achieve continuous quality improvement.

Definitions Corrective Action: Action taken to eliminate the root cause of a detected nonconformance. Preventive Action: Action taken to eliminate the cause of a potential nonconformance. Audit: Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which requirements are fulfilled. Quality Indicator: Defined data to monitor the quality system. Supporting Documents

Document Name Document # Document Location Process Improvement QP-1.2.9 Quality Manual Continuous Quality Improvement OP-8.1.1 Quality Manual

TITLE: Continuous Quality Improvement Process Revision Date: Document Number: OP-8.1.2 Status: Draft Section: Process Improvement Page: 2 of 2


PREVENTIVE ACTION CORRECTIVE ACTION

Review non conformances

Determine the root causes of non conformances

Evaluate the need for corrective action to ensure non conformances do not re-occur

Determine and implementing corrective action taken

Record the results of corrective action taken

Review the effectiveness of corrective action taken

Non conformances

Potential non conformances

Review the effectiveness of preventive action taken

Record the results of preventive action taken

Determine and implement preventive action taken

Evaluate the need for preventive action to ensure that non conformances do not occur

Determine the root causes of potential non conformances

Potential non conformances

Review laboratory data and information to determine where potential non conformances

exist

CONTINUOUS QUALITY IMPROVEMENT

EVALUATION activities include: o RESOLUTION OF COMPLAINTS

o INTERNAL AUDIT

o ASSURING THE QUALITY OF

EXAMINATIONS (particularly participation in external quality assessments)

and…

o Periodic review of requests and samples o Assessment of user satisfaction

o Staff suggestions

o Quality indicators

o Quality Initiatives

o Review by external organizations


TITLE: Quality Improvement Plan Template Revision Date: Document Number: OP-8.1.2 Status: Draft Section: Quality System Essential Page: 1 of 3

NOTE: See Appendix I for explanation of Sections.

<INSERT EHNRI HEADER>

QUALITY IMPROVEMENT PLAN

Quality Improvement Plan Name: Author: Date Team Members:

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Purpose of Improvement: Scope: Improvement Objectives:


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Measures Curr ent Per fo rmance

Goal

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Change Concept to Implement

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Individual Roles & Responsibilities Communication Str ategy Review Schedule Risks


Appendix 1

Performance Improvement Plan Guidelines for Completion

Performance

Improvement Plan Name

The name of the process improvement or quality initiative.

Team Members A listing of the people (and respective areas of expertise) that have allocated time to assist with the project.

Purpose of Improvement

A statement that clearly defines the goals of the project. What is the team trying to accomplish? If the improvement plan is complex, several statements may be required.

Scope Are there constraints or limitations within the purpose of the improvement? What is the team responsible for, what are they not responsible for?

Improvement Objective A specific statement of a desired short-term condition or achievement.

Measures Data that will indicate if the improvement had its desired effect. It must include current information, as well as a goal.

Change Concepts to Implement

A list of changes instituted for improvement.

Individual Roles & Responsibilities

A detailed listing of Team Members responsibilities. This will ensure proper accountability and structure.

Communication Strategy

This section outlines the tools and processes used to communicate process improvement information.

Review Schedule This section is key to making the process improvement plan manageable by clearly defining the dates and deliverables for the quality initiative.

Risks Potential risks associated to the improvement plan (or not doing the plan).



TITLE: Nonconforming Laboratory Events Revision Date: Document Number: OP-8.2.1 Status: Draft Section: Occurrence management Page: 1 of 17



Purpose

The purpose of this policy is to outline methods for reporting and managing nonconforming laboratory events, to ensure patient/client safety and continually improve the laboratory testing process. The purpose of reporting laboratory nonconforming events is to create a culture of safety within the organization by establishing a reporting and management system for actual and potential (near miss) adverse events, including the appropriate follow-up.

Policy

EHNRI will develop and maintain a comprehensive system of identification, investigation and correction of events with potential adverse outcomes. Supporting statements

Step Action

1. Develop the Laboratory Nonconforming Event Reporting Process: The Director, in collaboration with Team Leaders, will initiate and maintain the Laboratory Nonconforming Event Reporting Process.

2. Develop and maintain an event investigation process:

3. Develop and maintain a management review process and process improvement process for long-term corrective action:

4. Analyze the data: Compile event data

TITLE: Nonconforming Laboratory Events Revision Date: Document Number: OP-8.2.1 Status: Draft Section: Occurrence Management Page: 2 of 17



Step Action

5. Select presentation tool: Use tables for data that does not lend itself to graphical presentation. Use graphs to plot data that is time related, i.e. comparing data from one period to another. Use line graphs for plotting data that is time-related (comparing data from one period to another).

6. Report the data: Report the data to the appropriate groups/personnel as indicated in the process for each audit.

7. Retain

Responsibility It is the responsibility of all laboratory staff to identify and report nonconforming events. The Director General, Directorate Directors, Team Leaders and Quality Officers will ensure that nonconforming events are processed through the appropriate reporting system and that measures are taken to prevent and correct nonconforming events.

RESPONSIBILITY

All laboratory staff

• Participating in the detection, reporting, correction and prevention of near misses, complaints and nonconforming events.

• Reporting areas of nonconformance to the technical specialist or laboratory management as required.

• Making suggestions for improvement.

Team Leaders and Quality Officers

• Developing and implementing a standardized occurrence reporting system • Developing and implementing a system for classifying and tracking

occurrences. • Reporting trends and identifying opportunities for improvement. • Promoting a just culture where employees know that they should divulge

their errors so that others will learn and the information will be used to prevent future adverse events.

• Investigating non-conformances as it applies to their area, handling of non-conformances, dealing with the recall of results or any remedial actions.

Directorate Directors

• Encouraging the reporting of nonconforming events. • Soliciting input for correcting and preventing errors. • Establishing and promoting a non-punitive environment for employees to

report nonconforming events.




Director General

• Evaluating suggestions for improvement of nonconforming events to laboratory management.

• Promoting a non-punitive environment for employees to report nonconforming events.

• Authorizing resumption of examinations as it applies to their area.

Classification of Nonconforming Events Refer to Appendix 1: Nonconforming Event Reporting Process Table Nonconforming Laboratory Event Process

What happens Who is Responsible Supporting Documents

Consider the medical significance of non conforming laboratory events • Notify the requesting clinician/patient care area

where indicated. • Document each episode of non-conformance.

• Technical Specialists • Lab Management

(Director, Team Leader • Staff

Define and take corrective action immediately • If necessary, examinations should be halted and

reports held as necessary. • Results of non conforming examinations already

released are amended and error corrected in LIS. • Testing should be continued on comparable

system.

• Technical Specialists • Service Chiefs • Lab Management • Staff

If incorrect reports have been released: • The clinician/patient care area must be notified and

the reports are corrected. Results of non-conforming examinations already released are amended and error corrected

• Technical Specialist • Lab Management

(Director, Team Leader)

Process for Corrective Action includes: • Investigation to determine underlying root causes

of the problem. • Corrective actions shall be appropriate to the

magnitude of the problem and risks encountered. • Results of any corrective action shall be reviewed

by Laboratory Management to ensure that corrective actions taken were effective in overcoming the problem originally defined.

• Changes implemented to operational processes

• Technical Specialist • Laboratory Management

( Director, Team Leader).




What happens Who is Responsible Supporting Documents

resulting from corrective action investigations shall be documented.

Root cause Analysis and Corrective Actions are taken: • When non-conformance is detected, consideration

should be given to auditing the relevant testing process


(Director, Team Leader)

Corrective Actions

Review each episode of non-conformance: • Trends in non-conformance shall be monitored to

allow implementation of corrective action. • Each episode of non-conformance will be reviewed

by Operations teams/Laboratory Management.


(Director, Team Leader) • Staff

Corrected and Preventive Action

Laboratory Non-conforming Event Reports will be filed as indicated:

• All non-conforming events shall be maintained in the Problem Log Manager Component of the document control system.

• Appropriate staff

Lab Nonconforming Event Procedure

Definitions:

Corrective action: Action to eliminate the (root) cause of a detected nonconforming event. Event: Unexpected and undesired incident associated with the quality, appropriateness or timeliness of laboratory testing that affects or has the potential to affect the care or services provided to patients/clients on whom testing is performed.

Just culture: Term used to describe a balance between the need to hold individuals accountable for their actions and the need to maintain a learning environment where there is frank and honest discussion of operational problems. A just culture encourages an atmosphere of trust in which people provide essential safety-related information and in which they recognize unacceptable performance.




A just culture supports:

• Reporting of adverse events. • Learning from adverse events. • Promoting open discussions of adverse events. • Improving and implementing change(s) based on patterns and trends. • Developing “blame-free/blame-worthy” organization policies to manage adverse events and

support patient safety but not penalize staff for reporting. • Investigations that are fair and free of bias regardless of the event outcome or hindsight. • Ensuring feedback to staff.

A just culture does NOT support:

• Lack of accountability. • Intentional acts or sabotage. • Disciplinary issues such as theft of chemicals or equipment. • Knowingly failing to report a serious adverse event.

Near-miss: Term used to describe any process variation that did not affect an outcome, but for which a recurrence carries a significant chance of a serious adverse outcome. Synonyms: close-call Non-conformance event: The non-fulfillment of a specified requirement. Synonyms: accident, adverse event, error, event, incident, non-conformance, occurrence. Patient Safety: The state of continually working toward the avoidance, management, and treatment of unsafe acts within the healthcare system. Preventive Action: Action taken to eliminate the cause of a potential nonconformity or other undesirable potential situation. Remedial Action: Action taken to correct a recognized nonconformance. Remedial action usually does not address or remove the root cause of the problem. Risk: The probability of danger, loss or injury within the healthcare system.




Root-cause analysis: Process for identifying the basic or causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. Sentinel Event: An unexpected event involving the death or serious physical or psychological injury, or the risk of serious physical or psychological injury. Supporting Documents

OP-11.B.3 Laboratory Nonconforming Event Process Table OP-8.2.2 Laboratory Nonconforming Event Report Form OP-11.B.5 Laboratory Nonconforming Event Training Form

References NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. NCCLS document HS1-A2 [ISBN 1-56238-554-2]. NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

Appendix 1 LABORATORY NONCONFORMING EVENT PROCESS TABLE

ABBREVIATIONS:

PSR Patient safety report NCE Laboratory nonconforming event report QC Quality control TAT Turn-around time




DEFINITIONS: Critical (sample or test result) Irretrievable sample or test result that requires immediate medical attention (life-threatening). Critical test results are defined by the laboratory responsible for testing. Examples: Tissue Spinal fluid Timed samples such as blood cultures Blood gases Non-critical (sample or test result) Sample that can be recollected without surgical intervention and that does not place the patient at risk of harm. Examples: Venous blood sample Urine Stool Wound cultures

Specimen transport Transported by EHNRI employee (e.g. porter, lab staff) or couriers contracted by EHNRI to deliver samples from clinics and referral centres. Specimen transport NOT EHNRI initiated . Specimens transported to EHNRI by a courier contracted by the referring site.

Department of Pathology and Laboratory Medicine

Capital District Health Authority Halifax, Nova Scotia

TITLE: Laboratory Nonconforming Events Revision Date: March 14, 2008 Document Number: OP- Status: Draft Section: Quality Management Page: 8 of 17

Prepared by: Eugene Smith / Judy Arbique Authority: Dr. J. G. Heathcote NOTE: This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the electronic version prior to use.

NONCONFORMING EVENT

INPATIENT/AMBULATORY PATIENT SAMPLE

REFERRED PATIENT SAMPLE CANCELLATION

CODE EXPLANATION CRITICAL NON-CRITICAL CRITICAL NON-CRITICAL

Pre-analytical Events occurring during pre-analytical phase (specimen collection/transport/processing)

Unacceptable requisition PSR NCE NCE NCE Incomplete/illegible information on requisition Outcome: Delay or inability to perform testing

Incorrect test orders PSR

NCE

NCE

NCE

Test not ordered by provider Wrong test ordered by provider Outcome: Delay or inability to perform testing

Specimen collection delay

PSR

NCE

N/A

N/A Delay in sample collection

Outcome: Delay in analysis Specimen recollection required

PSR

NCE

NCE

NCE

Incorrect/expired container Specimen integrity / volume problem Sample leaking/broken





NONCONFORMING EVENT



CODE EXPLANATION CRITICAL NON-CRITICAL CRITICAL NON-

CRITICAL Pre-analytical Events occurring during pre-analytical phase (specimen

collection/transport/processing)

Specimen labeling (not reported) PSR NCE

NCE

NCE

Sample mislabeled Sample label missing Sample label incomplete Sample label illegible Sample label does not match requisition/LIS test order Outcome: Delay in testing and result reporting

Specimen labeling (results reported) PSR PSR

PSR

PSR

Sample mislabeled Sample label missing Sample label incomplete Sample label illegible Sample label does not match requisition/LIS test order Outcome: Test result reported before error recognized

Specimen transport (CDHA initiated) PSR NCE PSR NCE

Sample loss, breakage, delay No sample for test ordered Compromised transport (e.g. temperature requirements not acceptable)

Specimen transport (NOT CDHA initiated) PSR NCE NCE NCE

Sample loss, breakage, delay No sample for test ordered Compromised transport (e.g. temperature requirements)





NONCONFORMING EVENT




Pre-analytical Events occurring during pre-analytical phase (specimen collection/transport/processing)

Specimen accession/handling

PSR

NCE

PSR

NCE Sample loss, breakage, delay in laboratory

Specimen integrity PSR

NCE

NCE

NCE

Specimen leaking Insufficient formalin Clotted sample Hemolysed sample Possible contamination Incomplete filling of blood tubes Specimen too old

Specimen volume PSR NCE NCE NCE Insufficient sample for analysis

One identifier/Absence of unique identifier PSR NCE

NCE

NCE

Name only Name and date of birth Unique identifier only

Delay in testing/reporting PSR PSR NCE NCE Miscellaneous factors that results in delay testing/result reporting





NONCONFORMING EVENT




Analytical Events occurring during analytical phase (testing/analysis/examination)

Testing not performed correctly Test results not affected

PSR

NCE

PSR

NCE

Incorrect reagent Expired reagent SOP not followed Outcome: Delay or potential delay in reporting critical results

Testing not performed correctly Test results affected but NOT reported)

PSR

NCE

PSR

NCE

Incorrect reagent Expired reagent Failure to follow procedure Outcome: Delay or potential delay in reporting critical results

Testing not performed correctly Test results affected AND reported)

PSR

PSR

PSR

PSR

Incorrect reagent Expired reagent Failure to follow procedure Outcome: Real/potential client/patient harm

Failure to follow procedure Test results affected but NOT reported

PSR NCE

PSR

NCE Technical procedure not followed. Outcome: Delay or potential delay in reporting critical results

Failure to follow procedure Test results affected AND reported

PSR

PSR

PSR

PSR Technical procedure not followed.

Outcome: Real/potential client/patient harm

Testing delayed / TAT not met

PSR

PSR

PSR

PSR

Laboratory established turn-around time not met Outcome: Delay or potential delay in reporting critical results





NONCONFORMING EVENT





QC not performed correctly Test results unaffected

PSR

NCE

PSR

NCE Outcome: Delay or potential delay in reporting

critical results

QC not performed correctly Test results affected but NOT reported

PSR

NCE

PSR

NCE Outcome: Delay or potential delay in reporting

critical results

QC not performed correctly Test results affected AND reported

PSR

PSR

PSR

PSR Test result may or may not have been affected


Test results released before testing completed

PSR

PSR

PSR

PSR Regardless of whether patient/client is affected


NONCONFORMING EVENT


REFERRED PATIENT SAMPLE

CANCELLATION CODE EXPLANATION





CRITICAL NON-CRITICAL CRITICAL NON-CRITICAL Analytical Events occurring during analytical phase

(testing/analysis/examination)

Reagent problem Test results unaffected

PSR

NCE

PSR

NCE

Product expired Change in lot number unrecognized Recalled product lot number Reagent prepared improperly Reagent stored improperly Outcome: Delay or potential delay in reporting critical results

Reagent problem (Test results affected but NOT reported)

PSR

NCE

PSR

NCE

Product expired Change in lot number unrecognized Recalled product lot number Reagent prepared improperly Reagent stored improperly Outcome: Delay or potential delay in reporting critical results

Reagent problem Test results affected AND reported

PSR

PSR

PSR

PSR

Product expired Change in lot number unrecognized Recalled product lot number Reagent prepared improperly Reagent stored improperly Outcome: Real or potential patient harm

Calibration errors Test results unaffected

PSR

NCE

PSR

NCE Outcome: Delay or potential delay in

reporting critical results Calibration errors Test results affected but NOT reported

PSR

NCE

PSR

NCE Outcome: Delay or potential delay in

reporting critical results Calibration errors Test results affected AND reported

PSR

PSR

PSR

PSR Outcome: Real or potential patient harm





NONCONFORMING EVENT





Equipment problem Test results unaffected

PSR

NCE

PSR

NCE

Fluctuating power supply Deterioration of photometric light source Bubbles in reagent lines Unstable ambient temperature Outcome: Delay or potential delay in reporting critical results

Equipment problem Test result affected but NOT reported)

PSR

NCE

PSR

NCE

Fluctuating power supply Deterioration of photometric light source Bubbles in reagent lines Unstable ambient temperature Outcome: Delay or potential delay in testing and reporting of critical results

Equipment problem Test result affected AND reported

PSR

PSR

PSR

PSR

Fluctuating power supply Deterioration of photometric light source Bubbles in reagent lines Unstable ambient temperature Outcome: Real or potential client/patient harm

Testing/reporting delays PSR NCE PSR NCE Events that result only in delay of analysis or reporting

NONCONFORMING


REFERRED PATIENT SAMPLE

CANCELLATION CODE EXPLANATION





EVENT CRITICAL NON-CRITICAL CRITICAL NON-CRITICAL

Post-analytical Events occurring during post-analytical phase (result reporting/communication)

Interpretation of results Results not affected

PSR

NCE

PSR

NCE

Results misinterpreted Calculation error Outcome: Delay or potential delay in result reporting of critical results

Interpretation of results Results affected but NOT reported

PSR

NCE

PSR

NCE

Results misinterpreted Calculation error Outcome: Delay or potential delay in reporting of critical results

Interpretation of results Test results affected AND reported

PSR

PSR

PSR

PSR

Results misinterpreted Calculation error Outcome: Real or potential patient/client harm

Interpretation of results Amended pathology reports PSR PSR PSR PSR

Results misinterpreted – report reviewed by Service Chief of AP and appropriate pathologists Outcome: Real or potential patient/client harm

Data entry/Clerical error Test results not affected

PSR

NCE

PSR

NCE

Errors during entry of test result Outcome: Delay or potential delay in reporting of critical results

Data entry/Clerical error Test results affected but NOT reported

PSR

NCE

PSR

NCE

Errors during entry of test result Outcome: Delay or potential delay in reporting of critical results

Data entry/Clerical error Results affected AND reported

PSR

PSR

PSR

PSR

Errors during entry of test result Outcome: Real or potential patient/client harm





NONCONFORMING EVENT




Post-analytical Events occurring during post-analytical phase (result reporting/communication)

Delay in transmission/communication of test results PSR PSR/NCE PSR PSR/NCE Delay in results

Outcome: Real or potential patient/client harm Error in transmission/communication of test results

PSR PSR PSR PSR Wrong provider Error in communication between information system and electronic medical number

Failure to report critical/alert value PSR PSR PSR PSR Results not communicated Outcome: Real or potential patient/client harm

Delay in reporting PSR PSR PSR PSR Miscellaneous factors that results in delay testing/result reporting





NONCONFORMING EVENT




Other miscellaneous Events that do not fit analytical phases Purchasing / stores NCE NCE NCE NCE Receiving / delivery NCE NCE NCE NCE Vendor problem NCE NCE NCE NCE Waste management NCE NCE NCE NCE Environment / housekeeping NCE NCE NCE NCE Inventory NCE NCE NCE NCE LIS system problems NCE NCE NCE NCE

If test results delayed or the potential for harm to the patient/client results, report to Patient Safety Reporting system. If events result in real or potential harm to laboratory staff, report to SAFE, NOT PSR, unless the event involves a critical sample that requires recollection in which case, the event is reported to SAFE and PSR. If questioning whether event should be reported, contact the Quality Coordinator.