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 I -1 I-2 I3 I4 Document Title Introduction and Purpose Description and Role of Departments Vision, Mission and Value Statements Scope of Operations Page

II. ........................................................................... QUALITY POLICIES Document Number QP- 1.1.1 QP-1.1.2 QP-1.1.3 Document Title Quality Policy Statement and Quality Goals Director Generals Review of Quality Systems Director Generals Review of the Quality Manual QUALITY SYSTEM ESSENTIALS Documents and Records Policy Personnel Policy Equipment / Reagents / Supplies Policy Purchasing and Inventory Policy Process Control Policy Information Management Policy Occurrence Management Policy Assessment Policy: Internal and External Process Improvement Policy Service and Satisfaction Policy Facilities and Safety Policy Page

QP-1.2.1 QP-1.2.2 QP-1.2.3 QP-1.2.4 QP-1.2.5 QP-1.2.6 QP-1.2.7 QP-1.2.8 QP-1.2.9 QP-1.2.10 QP-1.2.11

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III. ......................................................................... OPERATIONAL POLICIES OP 2 ORGANIZATION Document Title Administrative Organizational Chart Department Organizational Structure Department Operational Committees Terms of Reference Laboratory Executive Committee Laboratory Administration Committee

Document Number OP-2.0 OP-2.1 OP-2.2 OP-2.2.1 OP-2.2.2

Page

Document Number OP-3.1 OP-3.2 OP-3.3 OP-3.4

OP 3 PERSONNEL Document Title Orientation, Training and Competency Orientation Program Training and Initial Competency Competency Assessment Program Continuing Education Job Descriptions

Page

Document Number OP-4.1 OP-4.2 OP-4.3 OP-4.4 OP-4.5 OP-4.6 OP-4.7 OP-4.8

OP 4 DOCUMENTS & RECORDS Document Title Management and Numbering of Documents Quality and Policy Document Template Process Document Template Technical Procedure (SOP) Template Form Template Retention Directives for Laboratory Guidelines for Citing References Document Creation, Review, Change and Deletion Request Process

Page

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OP 5 EQUIPMENT, REAGENTS, SUPPLIES Document Number Document Title 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 Title Laboratory Path of Workflow Specimen Acceptance and Rejection Specimen Label Requirements Process for Mislabeled/Unlabeled Specimens Laboratory Test Utilization Retention Directives Diagnostic Material Technical Procedures (SOPs) Method Validation Guidelines Reference Ranges Critical Results Reporting Critical Values Discrepant and Corrected Results Final Report OP 7 QUALTY ASSURANCE Document Title Internal QC Program External QC Program Planning and Selection of Quality Control Rules and Procedures Establishing Target Values for QC Documentation and Review of QC Results

Page

Document Number OP-6.1.1 OP-6.1.2 OP-6.1.3 OP-6.1.4 OP-6.1.5 OP-6.1.6 OP-6.2.1 OP-6.2.2 OP-6.2.3 OP-6.3.1 OP-6.3.2 OP-6.3.3 OP-6.3.4

Page

Document Number OP-7.1 OP-7.2 OP-7.3 OP-7.4 OP-7.5

Page

Document Number OP-8.1.1 OP-8.1.2 OP-8.2.1

OP 8 QUALITY IMPROVEMENT Document Title Continuous Quality Improvement Quality Improvement Plan Template Non-conforming Laboratory Events

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OP 9 PURCHASING AND INVENTORY Document Number Document Title

Page

Document Number

OP 10 INFORMATION MANAGEMENT Document Title

Page

Document Number

OP 11 FACILITIES AND SAFETY Document Title

Page

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

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.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

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TITLE: Description and Role of the Department Document Number: I-2 Section: QMS - Introduction

Revision Date: July 31, 2008 Status: Current 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 Document Number: I-3 Section: QMS - Introduction Revision Date: Status: Draft 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.

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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Hematology Laboratory The Hematology laboratory is comprised of: 1. General Hematology 2. Flow Cytometry The laboratory operates under the leadership and guidance of the Director of the Infectious and NonInfectious Diseases Research Directorate.

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TITLE: Scope of Operations and Services Document Number: I-4 Section: QMS - Introduction Clinical Bacteriology The Clinical Bacteriology laboratory is comprised of: 1. Clinical Bacteriology 2. Molecular Bacteriology 3. Mycology 4. Media Preparation and Distribution

Revision Date: Status: Draft Page: 2 of 4

The laboratory operates under the leadership and guidance of the Director of the Infectious and NonInfectious Diseases Research Directorate. Parasitology The Clinical Parasitology laboratory is comprised of: 1. Clinical Parasitology 2. Molecular Parasitology 3. Entomology The laboratory operates under the leadership and guidance of the Director of the Infectious and NonInfectious Diseases Research Directorate. HIV Molecular Laboratory The HIV Molecular laboratory is comprised of: 1. HIV Sequencing (HIV Genotype) 2. HIV Drug Resistance 3. HIV Viral Load and DNA-PCR The laboratory operates under the leadership and guidance of the Director of the Infectious and NonInfectious Diseases Research Directorate. Tuberculosis Laboratory The Tuberculosis laboratory is comprised of: 1. TB Culture and Sensitivity 2. TB Line Probe Assay The laboratory operates under the leadership and guidance of the Director of the Infectious and NonInfectious Diseases Research Directorate. Rabies Diagnostic Laboratory The Rabies Diagnostic laboratory is comprised of: 1. Rabies Diagnosis 2. Vaccine Production and distribution The laboratory operates under the leadership and guidance of the Director of the Vaccine Production Research Directorate.

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TITLE: Scope of Operations and Services Document Number: I-4 Section: QMS - Introduction Pathology Laboratory The Pathology laboratory includes: Sample preparation and examination

Revision Date: Status: Draft Page: 3 of 4

The laboratory operates under the leadership and guidance of the Director of the Infectious and NonInfectious Diseases Research Directorate. Central Reception The centralized specimen reception is comprised of: 1. Phlebotomy 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 physicians 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.

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

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TITLE: Scope of Operations and Services Document Number: I-4 Section: QMS - Introduction

Revision Date: Status: Draft Page: 4 of 4

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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Purpose To define the intentions and direction of the Ethiopian Health and Nutrition Research Institutes 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 EHNRIs 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 EHNRIs 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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Director Generals Review of the Quality Management System (QMS) Document Number: QP-1.1.2 Section: Quality Management System Revision Date: Status: Draft 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 1. Action 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 Prepare a schedule: The Director Generals review of the QMS shall occur at least annually. Define the inputs: The Director Generals 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

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TITLE: Director Generals Review of the Quality Management System (QMS) Document Number: QP-1.1.2 Section: Quality Management System 4.

Revision Date: Status: Draft Page: 2 of 4

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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. 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. 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. 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 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.

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TITLE: Director Generals Review of the Quality Management System (QMS) Document Number: QP-1.1.2 Section: Quality Management System

Revision Date: Status: Draft Page: 3 of 4

DIRECTORS REVIEW OF THE QUALITY SYSTEM Process: The Director shall review EHNRIs 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.
INPUT AGENDA (Issued by the Director General)
o o o o o o o o o o Results of Audits Customer Feedback & Complaints QC/PT Results Status of Preventive Actions and Corrective Actions Follow up on Action (Previous Meetings) QMS Changes or Suggestions Quality Indicators Suitability of Policies Reports from Managerial and Supervisory Personnel Change in Volume and Type of Work Undertaken

PROCESS

MEETING (Held annually or as indicated by the Director General)

o o o o Discuss Agenda Items Decide on Required Actions Set Responsibilities Set Dates for Completion or Monitoring

OUTPUT

MINUTES/ACTIONS (Issued within 3 days of meeting, maintained by the Director General)

o o o o o

Changes to the QMS Monitoring Actions Improvement of the QMS & Processes Identify Resource Needs Communicate/Distribute Report

ATTENDEES:
Deputy General Directors Directorate Directors

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TITLE: Director Generals Review of the Quality Management System (QMS) Document Number: QP-1.1.2 Section: Quality Management System Responsibility Directorate Director

Revision Date: Status: Draft Page: 4 of 4

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 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 Director Generals Review of the Quality System Form 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. Document # QP-1.C (Form) Document Location Quality Manual

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Directorate Directors Review of the Quality Manual Document Number: QP-1.1.3 Section: Quality Management System Revision Date: Status: Draft Page: 1 of 2

Purpose To provide guidelines for the Laboratory Directors review and implementation of the Quality Manual Policy A Quality Manual is a document stating EHNRIs 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 EHNRIs 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 Directorate Directors Reviews, approves and ensures compliance with the Quality Manual 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

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TITLE: Directorate Directors Review of the Quality Manual Document Number: QP-1.1.3 Section: Quality Management System

Revision Date: Status: Page: 2 of 2

Supporting Documents Document Name Quality Policy Statement and Quality Goals Director Generals Review of the Quality System Retention of Records and Diagnostic material 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. Document # QP-1.1.1 QP-1.1.2 OP-4.60 Document Location Quality Manual Quality Manual Quality Manual

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Purpose To provide guidance and direction for the processes and procedures used in managing the EHNRIs 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.

Supporting statements
Document Creation Document Control EHNRI uses a standardized format for creating documents. 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. EHNRI follows a process for the review and approval of documents prior to implementation and distribution, and periodically thereafter. 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. Documents are archived electronically, stored in a manner that prevents loss, damage or unauthorized access and can be retrieved as required. Records are stored for a designated period of time in a location that will allow easy retrieval and will prevent loss or damage.

Document Review and Approval

Document Distribution

Document Archiving, Storage

Record Retention and Disposal

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TITLE: Documents and Records Document Number: QP-1.2.1 Section: Quality System Essentials

Revision Date: Status: Draft Page: 2 of 3

Record Review and Approval Record Change

Retention and disposal of records is defined in the Retention of Documents and Diagnostic Materials Policy. The Directorate Director, or designee, reviews and approves the content of patient records and reports. Alterations to records are verified by the person making the change.

Responsibility
Director General Laboratory Staff 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 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 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. Create and change documents and records as assigned Review and use new or changed documents and records

Team Leader

Quality Officer

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TITLE: Documents and Records Document Number: QP-1.2.1 Section: Quality System Essentials

Revision Date: Status: Draft Page: 3 of 3

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 OP-4.6 Quality Manual Diagnostic Material Guidelines for Citing References OP-4.7 Document Creation, Review, Change and Deletion OP-4.8 Quality Manual Request Process 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 GuidelineSecond Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Purpose To provide guidance for the processes to effectively manage the EHNRIs 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 Orientation Training Job descriptions outlining qualifications, duties and responsibilities are provided to technical, non-technical and support staff. EHNRI provides General Orientation to new employees. 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. Competence of staff is assessed and documented initially after training and periodically thereafter. 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 are conducted at regular intervals. The Directorate Director develops objectives using the Performance and Development Plan. The HRM Directorate maintains original copies of confidential personnel records of all employees. The Directorate Directors shall maintain copies of said records Staff collaborates with Human Resources Management Directorate, and other offices such as Safety.

Competency Continuing Education

Performance Appraisals

Personnel Records

Other Resources

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TITLE: Personnel Policy Document Number: QP-1.2.2 Section: Quality System Essentials

Revision Status: Draft Page: 2 of 3

Responsibility
Director General Laboratory Staff Has the qualifications to assume responsibility Ensures there are adequate staff resources to perform all laboratory functions Approves current job descriptions 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 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 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. 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 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

Directorate Director

Laboratory Team Leader

Quality Officer

Human Resources Management

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TITLE: Personnel Policy Document Number: QP-1.2.2 Section: Quality System Essentials

Revision Status: Draft Page: 3 of 3

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

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 GuidelineSecond Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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Ethiopian Health and Nutrition Research Institute

Addis Ababa, Ethiopia

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

Pur pose 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 manufacturers 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. EHNRI will establish criteria and methods for equipment installation. EHNRI will establish a means to uniquely identify each piece of laboratory equipment. EHNRI will develop a validation mechanism prior to implementation of equipment to ensure that it performs as intended and periodically thereafter as required. EHNRI will develop a means to establish a program for the calibration and due date for laboratory equipment. EHNRI will ensure that Standard Operating Procedures (SOP) for laboratory equipment are established, implemented, maintained and regularly updated according to regulatory guidelines and standards. EHNRI will ensure that SOPs and logs for equipment maintenance are established, implemented, maintained and regularly updated according to regulatory guidelines and standards. 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. EHNRI will develop criteria and a process for retiring and disposing of outmoded or obsolete equipment. EHNRI will maintain records of history related to the life and decommissioning for each piece of equipment.

Installation Identification Validation

Calibr ation Pr ogr am Oper ation

Maintenance Pr ogr am

Tr oubleshooting, Ser vice and Repair

Decommissioning and Disposal Equipment Files and Records

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

TITLE: Equipment, Reagents and Supplies Document Number : QP-1.2.3 Section: Quality System Essential

Revision Date: Status: Dr aft Page: 2 of 3

Responsibility
Director General Directorate Director Ensure adequate resources are available to fulfill laboratory needs for equipment, reagents and supplies 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. 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. 1. Participates in the validation process. 2. Participates in the maintaining of equipment, reagents and supplies.

Quality Officer and Team Leader

Laboratory Staff

Supporting Documents
This policy is supported by the following documents: Document Name Balance Calibration Pipette Calibration Reagent Water Quality Temperature and Humidity Monitoring and Alarm Program Handling, Storage and Transport of Equipment, Reagents and Supplies Medical Device and Product Alerts Centrifuge Management Program Equipment Records and Logs Equipment Management Control of Inventory Purchasing, Receipt, Storage and Validation of Reagents and Supplies Inventory Receipt, Reconciliation, and Storage Form Inventory Control Process Equipment Management Program Refer ences
NOTE: This is a CONTROLLED document for internal use only.

Document # OP-5.1 OP-5.2 OP-5.3 OP-5.4 OP-5.5 OP-5.6 OP-5.7

Document Location Quality Manual Quality Manual Quality Manual Quality Manual Quality Manual Quality Manual Quality Manual

pending pending pending pending pending pending

TITLE: Equipment, Reagents and Supplies Document Number : QP-1.2.3 Section: Quality System Essential

Revision Date: Status: Dr aft Page: 3 of 3

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 GuidelineSecond Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

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

EHNRI identifies materials and services needed to operate the laboratory and develops a system for their validation, control and management. EHNRI establishes a system to evaluate and select vendors of Vendor Qualification equipment, supplies and services. EHNRI has a system to define, document, periodically review and Purchase Agreements and Review make changes to purchase agreements. Inspection and Testing of Received EHNRI has a system to receive, inspect (and test where needed), accept, store and inventory incoming materials. Materials EHNRI has a system of handling and storage of reagents and supplies Storage and Handling of Materials 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. EHNRI has a process ensuring product notifications from Product Changes by Manufacturer manufacturers are identified and handled appropriately and in a timely manner. EHNRI ensures there is an inventory control process that addresses Inventory Management 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. EHNRI has a mechanism for vendor evaluation and feedback. Vendor Evaluation Identification of Materials and Services

NOTE: This is a CONTROLLED document for internal use only

TITLE: Purchasing and Inventory Document Number: QP-1.2.4 Section: Quality System Essential

Revision Date: Status: Draft Page: 2 of 2

Responsibility
Director General Directorate Director and Team Leader Ensure adequate resources are available to maintain supplies and equipment service. Ensure a purchasing and inventory control process is established for EHNRI 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. Collaborate with Director and Team Leader to ensure compliance with established policies and procedures. Ensures fiscally responsible use of reagents and supplies. Monitors inventory and reports to appropriate person when inventory levels need to be adjusted.

Quality Officer Laboratory Staff

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

NOTE: This is a CONTROLLED document for internal use only

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Supporting Statements and Process Control

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) EHNRI provides a Specimen Collection Manual to all appropriate specimen Specimen Collection Manual collection facilities. EHNRI ensures that well written technical procedures (SOPs) are available Technical Procedures 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 are established or validated for each test performed in the Reference Ranges EHNRI. Review of reference ranges occur as required. Validation of Methods and Validated methods are used to confirm that processes and procedures meet established criteria for performance. Procedures EHNRI develops and implements a quality control program. The program Quality Control & Intra/Inter Laboratory ensures comparability of results across all sites (inter), as well as comparability of results on analyzers at the same site (intra). Comparisons EHNRI participates in programs of external proficiency testing to verify External Proficiency Testing that the intended quality of results is achieved. EHNRI establishes critical values for examination results that are life Critical Values threatening, and has a process to ensure that critical results are communicated in a timely manner. EHNRI establishes turnaround times for each test as appropriate. Turn Around Times Retention of Specimens & Specimens and reported results are retained as per Retention of Documents and Diagnostic Material Policy. Reported Results Communicable and Reportable EHNRI complies with legislated requirements for reporting communicable and reportable diseases Diseases Resolution of Discrepant Results EHNRI has a process to deal with discrepant results. EHNRI documents alterations to records or results with the date, time and Corrected Reports the individual who made the changes. Laboratory Practice

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

TITLE: Process Control Document Number: QP-1.2.5 Section: Quality System Essential

Revision Date: Status: Draft Page: 2 of 4

Responsibility
Director General Directorate Director and Team Leaders Quality Officer Laboratory Staff Reviews and approves quality policies and ensures implementation of and compliance with said policies Ensure the development and implementation of a quality control program, and define acceptance/rejection criteria. Assess, justify, add or remove tests to/from the laboratorys 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 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. 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

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

TITLE: Process Control Document Number: QP-1.2.5 Section: Quality System Essential

Revision Date: Status: Draft Page: 3 of 4

Supporting Documents
Document Name Documents and Records Retention of Records and Diagnostic Material Pre-Analytical Laboratory Path of workflow Specimen Acceptance and Rejection Specimen Label requirements Process for Mislabeled/Unlabeled Specimens Laboratory Test Utilization Specimen Acceptance, Cancellation and Canned Text comments Requisition, Verbal and Add-On Tests Specimen Collection List of Examination Procedures Implementation Of a New Test New Test Implementation Form Transportation of Dangerous Goods Transport of Specimens Analytical Technical Procedures (SOPs) Method Validation Guidelines Reference Ranges General Review of Technical Procedure Manuals STAT Lists Job Aid Guidelines Post-Analytical Critical Results Reporting Critical Values Discrepant Results Final Report Results Management Release of Laboratory Report Communicable and Reportable Diseases Release of Specimens for Legal Purpose Document # OP-4.6 OP-6.1.1 OP-6.1.2 OP-6.1.3 OP-6.1.4 OP-6.1.5 pending pending pending pending pending pending pending pending OP-6.2.1 OP-6.2.2 OP-6.2.3 pending pending pending OP-6.3.1 OP-6.3.2 OP-6.3.3 OP-6.3.4 pending pending pending pending Quality Manual Quality Manual Quality Manual Document Location Quality Manual Quality Manual Quality Manual Quality Manual Quality Manual Quality Manual

Quality Manual Quality Manual Quality Manual Quality Manual

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

TITLE: Process Control Document Number: QP-1.2.5 Section: Quality System Essential

Revision Date: Status: Draft Page: 4 of 4

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 GuidelineSecond Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

PHASE l Inventory Planning

PHASE ll Systems Development

PHASE lll Procurement

PHASE lV Management

Supplies Analysis Forms Start

High Priority

Item Identification

Product Demographics

Frequency of Evaluation

Moderate Priority

Master Supply Lists

Yes Requisition

Supply Network Purchasing Receiving Accounts Payable Suppliers Receipt

Inventory Control Cards

No Storage Inventory Working Inventory

No

Yes

Stores Low Priority Lab Section Item Lists Start Central Sectional Refrigerated Special

Supplies Analysis Identification/Classification

Measuring Inventory

Controlling Inventory

Supply Ordering

Controlling Inventory

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Information Management Document Number: QP-1.2.6 Section: Quality System Essential Revision Date: Status: Draft 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. EHNRI establishes systems to ensure confidentiality of all patient records both manual and electronic. EHNRI provides a clean and well-maintained environment for the operation of computers and computerized equipment that complies with vendor specifications. Processes are in place to prevent unauthorized access to patient information in the LIS and laboratory instruments. Mechanisms are in place to identify individuals who enter, verify and release patient information. 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 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. Established processes and procedures are in place for the handling of requests for patient information/test results. Downtime procedures are in place to ensure the availability of patient test results during hardware or software failure. The IT Unit Chief or designate approves all significant changes in LIS. Policies, procedures and processes are in place for change control, training, and downtime. 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.

Confidentiality Computer Environment

Computer Access & Security Data Entry and Reporting Data Retrieval and Storage

Data Integrity

Requests for Information Computer Downtime Change Approval Computer Procedures Computer Validation

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

TITLE: Information Management Document Number: QP-1.2.6 Section: Quality System Essentials Computer System Maintenance

Revision Date: Status: Draft Page: 2 of 3 System maintenance and back-up is performed by the IT Unit on a regularly scheduled basis.

Responsibility
Director General Laboratory Staff Information Technology Unit Reviews and approves all computer and LIS policies that may affect patient care. Ensures adequate resources are readily available. 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. 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 Collaborates with Director and Team Leader to ensure compliance with established policies and procedures. Collaborates with RLCBD to ensure compliance with laboratory standards. Follows established policies, procedures, and processes for entering, verifying and releasing patient information/results in LIS Notifies appropriate individuals when computer problems are identified. 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.

Directorate Director and Team Leader

Laboratory Informatics Group (LIG)

Quality Officer

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

TITLE: Information Management Document Number: QP-1.2.6 Section: Quality System Essentials

Revision Date: Status: Draft Page: 3 of 3

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

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 GuidelineSecond Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Occurrence Management Document Number: QP-1.2.7 Section: Quality System Essential Revision Date: Status: Draft 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 patents 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 Remedial Action Corrective Action Preventive Action Investigating and Documenting Classifying Staff recognize adverse and nonconforming events and initiates reports. Adverse events and laboratory non-conformances (NCE) are documented and reported to the team leader. The person who identifies an adverse or non-conformance event takes immediate action to rectify the problem and documents action taken Action is taken to eliminate the root cause of a detected non-conformance Action is taken to eliminate the cause of a potential non-conformance EHNRI investigates adverse and non-conformance events and assigns staff to take corrective action when required to eliminate the root cause. All events are classified into adverse or non-conformance events according to level of severity of harm to patient and work processes involved. EHNRI analyzes the data from Patient Safety Reports and NCE for trends and patterns.

Analysis and Data Presentation The Directorate Directors reviews and prioritizes information for follow-up that may Directorate review and referral to Process include resource allocation or process improvement initiatives. improvement EHNRI has processes to resolve written and verbal complaints and respond to feedback Complaint resolution from clients. EHNRI supports a just culture where staff is willing to report adverse events and Just culture nonconformities without fear of punishment.
NOTE: This is a CONTROLLED document for internal use only.

TITLE: Occurrence Management Document Number: QP-1.2.7 Section: Quality System Essential

Revision Date: Status: Draft Page: 2 of 3

Responsibility
Director General Directorate Director Quality Officer Ensures implementation of and compliance with policies and supporting documents Ensures adequate staff resources are available to perform all laboratory functions Ensures that all non-conforming events are investigated, documented, corrected and reported Assesses all patient safety reports and reports to Director General 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 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. 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.

Team Leaders

Laboratory Staff

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

TITLE: Occurrence Management Document Number: QP-1.2.7 Section: Quality System Essential

Revision Date: Status: Draft Page: 3 of 3

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Supporting statements 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

External Assessment

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 departments performance and improvements of service offered. The findings are documented and reported. Action is taken on indicators that demonstrate unacceptable performance. 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.

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

TITLE: Assessments - Internal / External Document Number: QP-1.2.8 Section: Quality System Essential

Revision Date: Status: Draft Page: 2 of 3

Responsibility
Director General Directorate Director Reviews and approves internal audit policies Ensures there are adequate staff resources to perform internal audits 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 Establishes and trains audit teams Reviews and follows up on action plans related to QMS audits Develops and implements quality indicators Collaborates with the RLCBD to manage the internal assessment program Participate in the measurement of the quality indicators Participate in audits of the QMS

Team Leaders Quality Officer Laboratory Staff

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

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

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

TITLE: Assessments - Internal / External Document Number: QP-1.2.8 Section: Quality System Essential

Revision Date: Status: Draft Page: 3 of 3

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

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. 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. EHNRI has processes for ongoing monitoring of pre-analytical, analytical and postanalytical activities to meet customer satisfaction, based on measurable quality indicators that characterize the most important processes on a prioritized, cost-effective basis. 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). EHNRI has a process to assess corrective and preventive actions by reviewing quality reports, opportunities for improvement and improvements in outcomes.

Quality Teamwork

Quality Monitoring

Quality Improvement

Quality Review

NOTE: This is a CONTROLLED document for internal use only

TITLE: Process Improvement Document Number: QP-1.2.9 Section: Quality System Essential

Revision Date: Status: Draft Page: 2 of 3

Responsibility
Director General Directorate Director Laboratory Staff 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 Develops and reviews ENRIs 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 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

Team Leaders Officers

and

Quality

NOTE: This is a CONTROLLED document for internal use only

TITLE: Process Improvement Document Number: QP-1.2.9 Section: Quality System Essential

Revision Date: Status: Draft Page: 3 of 3

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

NOTE: This is a CONTROLLED document for internal use only

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Purpose To ensure the satisfaction of various client groups with EHNRIs services. Policy EHNRI shall actively seek and measure the satisfaction of its internal (including staff) and external clients. EHNRIs 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 Satisfaction surveys Monitoring EHNRI receives and responds to complaints EHNRI conducts satisfaction surveys with internal and external clients on a regular basis, including staff. 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 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 Collaborate with Director, Team Leader and RCLBD to monitor, evaluate and address customer needs and level of satisfaction.. 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

Directorate Director and Team Leader

Quality Officer Laboratory Staff

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

TITLE: Client Service and Satisfaction Document Number: QP-1.2.10 Section: Quality System Essential

Revision Date: Status: Draft Page: 2 of 2

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

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Safety and Facilities Document Number: QP-1.2.11 Section: Quality System Essential Revision Date: Status: Draft 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 laboratorys 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 Safety Committee The Safety Officer supports laboratory management on issues concerning safety. A safety officer is designated for each laboratory. The Laboratory Services Safety Team (LSST), with representation from all laboratories, meets on a regular basis to address safety concerns throughout the Institute. A safety manual, specific to the Institute is available to all staff. Safety procedures appropriate to the work environment are written and enforced. A safety audit is conducted annually by LSST. Members of the LSST conduct safety inspections at the Institute on a regular basis. Results of inspections, audits and corrective actions are documented and communicated to EHNRI Management. Hazardous areas are clearly identified through signage, or by labeling in the case of biological or chemical hazards. 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 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. 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

Safety Manual Safety Procedures Safety Audit Safety Inspections Safety Records Hazards Identification Reporting of Incidents/Accidents

Safety Training

Personnel Responsibilities

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

TITLE: Safety & Facilities Policy Document Number: QP-1.2.11 Section: Quality System Essential

Revision Date: Status: Draft Page: 2 of 4 procedures, as defined in the Laboratory Safety Manual and other manuals where applicable. 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. 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. Storage and disposal of dangerous materials are in accord with relevant regulations and safety lab practices. Chemicals used in the Laboratory are labeled, stored, handled and disposed of in compliance with safety regulations and generally accepted safe laboratory practice. Visitors to the Laboratory are made aware of hazards they may encounter. 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 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. The location and design of the laboratory supports the tasks carried out and optimizes workflow to ensure a safe and efficient workplace. 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. 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. Separate storage areas and conditions are adequate for samples, equipment, reagents, supplies, documents and records. The Institute provides a clean and well-maintained environment for computer equipment that complies with vendor specifications.

Protective Equipment

First Aid and Emergency

Dangerous Materials Chemical Safety

Visitors Electrical Safety

Fire Safety

Location & Design Environmental Conditions

Access

Storage Computer Environment

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

TITLE: Safety & Facilities Policy Document Number: QP-1.2.11 Section: Quality System Essential

Revision Date: Status: Draft Page: 3 of 4

Responsibility
Director General Quality Officer Ensure laboratory safety policies are implemented and enforced Ensures availability of adequate resources to perform all laboratory safety functions 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. 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. 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. Report safety deficiencies to supervisor or manager. Provide safety orientation and training to staff. Review Workplace Incident Reports. Perform safety audits and inspections. 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. Collaborates with the laboratory to plan for new or renovated facilities. Maintains facility services for ventilation, electrical, plumbing, painting, and carpentry.

Directorate Director & Team Leader

Laboratory Staff

Safety Officers

LSST

Engineering/Maintenance Services

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

TITLE: Safety & Facilities Policy Document Number: QP-1.2.11 Section: Quality System Essential

Revision Date: Status: Draft Page: 4 of 4

Supporting Documents
This policy is supported by the following policies: Document Name Laboratory Safety Manual Fire Safety Program Workplace Hazard Identification Inspections & Compliance Personal Protective Equipment MSDS Safety Checklists Workplace Incident Form Maintenance request form Document # pending pending Safety pending pending pending pending pending pending Document Location

&

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 GuidelineSecond Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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

TB, Other Bacterial & Mycot ic Diseases Research Team Malaria & Other Parasitic & Vector-born e Diseases Research team
HIV & Other Viral Diseases Research Team

Director of Infectious & Non-infectious Diseases Research

Health Care Research Team

Non-Infectious Disease Research Team Zoonotic disease research team Food Science & Tech Research Team Director of Nutrition & Food Science Research Nutrition Research Team Traditional & Modern Medicine Research Tea Director of Traditional & Modern Medicine Research
D/D/G for RTT

Legal office

Audit & inspection

Ethics & Anticorruption Office

Director of Regional Laboratories Capacity Building

Vaccines & Diagnostic Reagent Production Team

Director of Vaccine & Diagnostics Production

Director of Compliance

Technology Transfer & Research Translation Team

Director of Technology Transfer & Research Translat ion

D/D/G for PHEM

Director General

Director of Preparedness, Early Warning, Response & Recovery Team

Public Relation Office

Scientific & Ethical Review Office

Planning, Monitoring & Evaluation Income & Disbursement team Accounting Register team

Director of Planning and Finance

Procurement & Property Administration Team

Human Resource Management

Director of HRM & genera service

Transport & general service team

Ethiopian Health and Nutrition Institute Addis Ababa, Ethiopia

TITLE: Department Organizational Structure Document Number: OP-2.1 Section: Organization Revision Date: Status: Draft 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 Directorate Director References CAN/CSA-Z15189-03 Medical Laboratories-Particular Requirements for Quality and Competence; 5.1.1:12. Reviews and approves policy Develops organizational charts specific to areas of responsibility Updates laboratorys organization chart for the Quality Manual

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Operational Committees Document Number: OP-2.2 Section: Organization Revision Date: Status: Current 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 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. The Director General or Deputy and the Directorate Directors can authorize the establishment or discontinuance of all Operational Committees. All committees establish Terms of Reference that include purpose, membership and meeting procedures. All committee members respect confidentiality by keeping discussions confidential unless otherwise agreed. Committee decisions are reached through consensus after fair and open discussions. Committee members are expected to disclaim any potential conflict of interest and, if necessary, excuse themselves from the meeting until the discussion is over. Minutes reflecting attendance, subjects discussed and actions to be taken are kept at all meetings. Each Operating Committee prepares an annual report containing a summary of activities.

Ad hoc Committees

Authorization

Terms of Reference Confidentiality

Decision Making Conflict of Interest

Meeting Minutes

Annual Report

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

TITLE: Operational Committees Document Number: OP-2.2 Section: Organization

Revision Date: Status: Current Page: 2 of 2

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

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Purpose To acquaint new staff with a personal and physical introduction to the laboratory and facility environment. Policy EHNRIs 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 Staff Transfer Laboratory Orientation New staff shall receive General Orientation to EHNRI Staff transferring to a new laboratory shall participate in the orientation process for that laboratory 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 EHNRI Laboratory Orientation What Happens New staff attend as per Orientation Policy Acquainted new staff with o EHNRIs mission, values and quality policy statement and goals o Laboratory tours o Laboratory organizational chart o General safety o Laboratorys policies o Work schedules

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

TITLE: Orientation Program Document Number: OP-3.1 Section: Personnel

Revision Date: Status: Draft 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 Participate openly in all orientation programs Notify the appropriate individual if further information is required

Laboratory Staff

Supporting Documents Document Title Orientation Program Retention Directives for Laboratory Records and Diagnostic Material Safety Orientation Checklist for New Staff Document # pending OP-4.6 pending Location Quality Manual

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Purpose To ensure that staff understand the sequence of work activities and the instructions for completing them properly. Policy EHNRIs 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: Competency: employees new to a laboratory 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. written work instructions that specify a way to carry out an activity, examination or step in a process. series of inter-related steps involved in an activity or examination that uses resources and is managed to transform inputs into outputs. process to provide and develop knowledge, skills, and behaviors to meet requirements.

Procedure: Process:

Training:

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

Retaining

Training and Competency Records

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

TITLE: Staff Training and Initial Competency Document Number: OP-3.2 Section: Personnel Training Development Process

Revision Date: Status: Draft Page: 2 of 3

Each Laboratory shall implement a training process based on these four stages of development. Stage 1. Training needs identified 2. Training guides developed 3. Training is implemented 4. Training outcomes evaluated Description Work processes and procedures identified for training. Objectives, methods and materials are identified and developed. Preceptors are identified. Training is conducted. 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 Quality Safety Work Processes and Procedures Contents 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) Laboratory Information System (LIS) Services including e-mail, word processing, databases, spreadsheets, etc. Other computer applications used (document control, continuing education, etc) See Orientation Program Process in the path of workflow in which the staff member works Procedures performed

Computer

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TITLE: Staff Training and Initial Competency Document Number: OP-3.2 Section: Personnel

Revision Date: Status: Draft Page: 3 of 3

Responsibility Directorate Director and Team Leader Preceptors/Expert 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 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 Provide staff training Ensure all appropriate documentation is completed

Laboratory Staff

Supporting Documents Document Title Laboratory Orientation Program Competency Assessment Policy Competency Assessment Procedure Training Checklist References NCCLS. A Quality Management System Model for Health Care; Approved GuidelineSecond 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 GuidelineSecond Edition. NCCLS document GP21A2 (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 Document # pending OP-3.3 pending pending Document Location Quality Manual

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Competency Assessment Program Document Number: OP-3.3 Section: Personnel

Revision Date: Status: Draft Page: 1 of 3

Purpose To ensure ongoing competency of staff Policy EHNRIs 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 Program Assessment Failure to competency demonstrate 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 shall be performed and documented on all staff annually, or as required, ensuring quality patient care. Each laboratory shall establish competency processes and procedures. 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.

Competency Assessments

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

TITLE: Competency Assessment Program Document Number: OP-3.3 Section: Personnel

Revision Date: Status: Draft Page: 2 of 3

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

Laboratory Staff

Preceptors

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 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 Assess staff competency and report to management Ensure documentation is complete

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

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

TITLE: Competency Assessment Program Document Number: OP-3.3 Section: Personnel

Revision Date: Status: Draft Page: 3 of 3

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; 5.1:23. NCCLS. A Quality System Model for Health Care Second Edition; Approved Guideline. NCCLS document HS1A2, November 2004; 5.2:18.

NCCLS. Training and Competence Assessment; Approved GuidelineSecond Edition. NCCLS document GP21A2 (ISBN 1-56238-531-3). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Continuing Education Document Number: OP-3.4 Section: Personnel Revision Date: Status: Draft 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

CE Programming

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 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: Course: a presentation where information on a specific knowledge or skill is given before a targeted audience. 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.

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

TITLE: Continuing Education Document Number: OP-3.4 Section: Personnel

Revision Date: Status: Draft Page: 2 of 3

Continuing Education Process ACTIVITY Internal Continuing Education WHAT HAPPENS Staff attend CE sessions as laboratory operations and scheduling permit Staff access current reference materials Staff present educational sessions 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

External Continuing Education

Responsibility Directorate Directors and Team Leaders Quality Officer Laboratory Staff Facilitate CE opportunities/resources Establish and maintain attendance logs for internal CE sessions Review CE requests Collaborates with Director, Team Leader and RLCBD to identify, coordinate appropriate CE opportunities for all 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 Travel Policy Laboratory Continuing Education Request Form Attendance Log Document # pending pending pending Locations

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

TITLE: Continuing Education Document Number: OP-3.4 Section: Personnel

Revision Date: Status: Draft Page: 3 of 3

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.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Pur pose 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 laboratorys 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. Suppor ting Statements Document Contr ol 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. 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

Document System

Identification

NOTE: This is a CONTROLLED document for inter nal use only.

TITLE: Management and Numbering of Documents Document Number: OP-4.1 Section: Documents and Records Supporting Statements (continued) Appr ovals

Revision Date: Status: Draft Page: Page 2 of 4

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 Directorate Director and related templates and forms Standar dized Identifier s

Depar tment Chemistry Pathology TB Laboratory Hematology Bacteriology Parasitology Mycology HIV Rabies Diagnostic Laboratory Public Health Laboratory LIS Safety Shared Services

Code CHE PAT TB HEM BAC PAR MYC HIV RDL PHL LIS SAF SHS

Type of Document Quality Policy Quality Audit Operational Policy Organization and Personnel)

(includes

Code QP QA OP

Technical Processes & Procedures Forms

TP F

Document Identification Examples Document Type Quality Policy Hematology Form Chemistry Procedure Technical Unique Identifier QP-# HEM-F-# CHE-TP-# Document Type Operational Policy HIV Lab Technical Process TB Laboratory Form Unique Identifier OP-# HIV-TP-# TB-F-#

NOTE: This is a CONTROLLED document for inter nal use only.

TITLE: Management and Numbering of Documents Document Number: OP-4.1 Section: Documents and Records Responsibility Dir ector Gener al Dir ector ate Dir ector

Revision Date: Status: Draft Page: Page 3 of 4

Team Leader Quality Officer Labor ator y Staff

Reviews and approves new and revised quality management policy documents. 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 Reviews documents according to an established schedule, ensuring document processes and procedures are implemented. Reviews technical documents to ensure compliance with applicable regulations and standards. Create, revise, review and retain documents and records as assigned.

Supporting Documents Document Title Policy Document Template Process Template Technical Procedure Template (SOP) Form Template New Document Creation, Review, and Approval Process Document Distribution and Notification Process Use and Printing of Controlled Documents Creation and Maintenance of Master File//Index Process Record Retention Process and Directives Document # OP 4.2 OP 4.3 OP 4.4 OP 4.5 Document Location Quality Manual Quality Manual Quality Manual Quality Manual

pending pending pending pending

OP 4.6 Quality Manual

NOTE: This is a CONTROLLED document for inter nal use only.

TITLE: Management and Numbering of Documents Document Number: OP-4.1 Section: Documents and Records

Revision Date: Status: Draft Page: Page 4 of 4

Refer ences NCCLS. A Quality Management System Model for Health Care; Approved GuidelineSecond 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 GuidelineFourth 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.

NOTE: This is a CONTROLLED document for inter nal use only.

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

< INSERT EHNRI HEADER> TITLE

What Happens Who is responsible Supporting documents

1)

2)

3)

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

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TITLE: Technical Procedure (SOP) Template Document Number: OP-4.4 Section: Documents and Records

Revision Date: Status: Draft Page: 2 of 4

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
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TITLE: Technical Procedure (SOP) Template Document Number: OP-4.4 Section: Documents and Records

Revision Date: Status: Draft Page: 3 of 4

Step

Action

Step

Action

Calculation

Result Interpretation

Expected Values Analyte Reference Range Male Female Toxic range Analytical Range Units

Limitations

Procedural Notes

Principle

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

TITLE: Technical Procedure (SOP) Template Document Number: OP-4.4 Section: Documents and Records Clinical Utility

Revision Date: Status: Draft Page: 4 of 4

Related Procedures and Documents

Reference

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

< INSERT EHNRI HEADER> TITLE

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Retention Dir ectives for Labor ator y Recor ds Document Number : OP-4.6 Section: Documents and Records Revision Date: Status: Dr aft Page: 1 of 6

Pur pose 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. Suppor ting statements Retention Time Per iod Retention time periods are established for all records that comply with accreditation and regulatory requirements. 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. Recor d Stor age 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 Guidelines

Retention Times:
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TITLE Retention Dir ectives for Labor ator y Recor ds Document Number : OP-4.6 Section: Documents and Records

Revision Date: Status: Dr aft 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 1.1.2 1.1.3 1.1.4 1.1.5 Aliquot Collection Labels Daily Counts Phone Log for Couriers Physician Authorization to Collect Blood Specimen Receiving Logs 1 week Discard when entered Indefinitely 4 months Indefinitely 2 years

1.2 1.3

Proficiency Testing Results Generated Worksheets Reports 1.3.1 1.3.2 Electronic Worksheet (LIS) Paper-based Worksheets

1 year 1 year LIS-indefinitely 2 years 1 year on-line/indefinite storage on DVD Life of instrument + 3 years 5 years 5 year 20 years (archive electronically)

1.4 1.5 1.6 1.7 1.8 1.9 1.10

IQC Result IQC results (Paper) Electronic Management Reports Equipment Maintenance Financial Reports/Variances/Workload/Statistics Inventory Sheets Laboratory Methods/Manuals

1.11 1.12

Patient Reports (LIS) Patient Reports-Method Specific 1.10.1 1.10.2 Patient Report off Instrument Patient Report off Instrument and waiting for differential

Indefinite storage on DVD Refer to specific SOP Discard after results verified Discard after results verified

1.13

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

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TITLE Retention Dir ectives for Labor ator y Recor ds Document Number : OP-4.6 Section: Documents and Records
1.13.6 1.13.7 1.13.8 1.13.9 1.13.10 1.14 1.15 1.16 OT Records and Books Standby and Callback Records Time Capture/Daily Attendance Time-off and Vacation Requests Work Schedules/Shift Change Requests

Revision Date: Status: Dr aft Page: 3 of 6

1 year + current year 1 year + current year 1 year + current year 1 year + current year 1 year + current year 1 year + current year Refer to Method Specific SOPs

Phone Records Fax Records (Patient records/reports) Purchasing Documents 1.13.1 1.13.2 1.13.3 Packing Slips PO Contracts Reconciliation Receipt Record

1 year Length of contract + 1 year 1 year

1.17

Quality Control/Quality Assurance 1.14.1 1.14.2 1.14.3 1.14.4 1.14.5 QC Records (LJ graphs, cumulative 2 years summaries, temperature charts, corrective action, etc) Control assay sheets that come with 2 Years QC product Intra-laboratory Examination Comparison 2 years QC Review Sheets 2 years Working Copies of External Surveys/PTs 2 Years

1.18

Quality Management Documents 1.18.1 1.18.2 1.18.3 1.18.4 1.18.5 1.18.6 1.18.7 1.18.8 1.18.9 1.18.10 1.18.11 1.18.12 1.18.13 1.18.14 1.18.15 1.18.16 1.18.17 Audits Committee minutes Communication memos Complaints/compliments Court Cases Equipment Calibration (pipettes, balances, etc.) Management Reviews of QMS Method/Process Validations NCE (lab nonconformance events) Obsolete Records Quality Improvement Records Records of External Inspections, Accreditation and Peer Reviews Referral Lab Agreements and Contracts Register of Referral Specimens Software Application Validation Records Supplier Qualification Record Terms of References for Committees 3 years 3 years 5 years 7 years Indefinite 3 years 3 years Life of instrument + 3 years 7 years 10 years 3 years 3 years Duration of contract + 2 years 3 months Life of instrument + 3 years 3 years As long as committee exists: revised version supersedes previous edition

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TITLE Retention Dir ectives for Labor ator y Recor ds Document Number : OP-4.6 Section: Documents and Records
1.19 Records of analysis, calculations and observations affecting the result and laboratory report (or electronic version) Reference Laboratory Results Research Proposal Requests/Protocols/ Agreement Letters/Invoices Safety Records 1.22.1 1.22.2 1.23 Eyewash/Shower Checklists Workplace Audits

Revision Date: Status: Dr aft Page: 4 of 6

Interfaced: unnecessary Manual or other: 1 year Refer to test specific guidance Indefinitely

1.20 1.21 1.22

5 years 5 years

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

2.0

SHARED SERVICES at Central Reception

RECORD MINIMUM DURATION OF RETENTION

2.1 2.1.1 2.1.2 2.1.3 2.1.4 5.1.5 2.2

Central Specimen Collection (CSA) Fax Transmission Confirmations Monthly Requisition Tally Sheets Problems Sheets (attach to requisition) Way Bills for Referred-out Testing Referred Out Problems (Sample/reports) Central Reporting 2.2.1 2.2.2 2.2.3 2.2.4 Fax Requests for missing Reports Laboratory Reporting Mail Out Records Notification Records for LIS Downtime Physician Addition/Change records 1 year 2 years 4 months 1 year 6 months 1 year + current year 1 year Management decision 5 years

2.3

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

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TITLE Retention Dir ectives for Labor ator y Recor ds Document Number : OP-4.6 Section: Documents and Records 3.0 TRANSFUSION SERVICE
RECORD 3.1

Revision Date: Status: Dr aft Page: 5 of 6

MINIMUM DURATION OF RETENTION

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 Statistical Reports 3.2.1 Workload, transfer of products 3.2.2 Month end TDR, BSR, FDL 3.2.3 Transfusion Report, Product Utilization, Received Days to Outdate, Expired units to Outdate, Transfer of Product, Pooled Products 3.2.4 Canadian Blood Services Reports 3.2.5 Final Disposition Reports 1 year Quality Assurance Reports 3.3.1 Result Review 3.3.2 Blood Bank Exception, Product Correction, 5 years Pre-wastage, C/T Ratios 3.3.3 Error Corrections, Lookback/Traceback Notifications, Product Recalls 9.3.4 Transfusion Committee Reports 9.3.5 Inspection of Incoming Reagents 9.3.6 Physician and Staff Signatures Patient Records 3.4.1 Patient Records 3.4.2 Emergency Drug Release, Special access Products 3.4.3 Transfusion Requests and Dispense Vouchers 3.4.4 Transfused Tags 3.4.5 Patient Transfusion Records 2 years current month + previous month 5 years 5 years

3.2

3.3

current + previous day Indefinitely 5 years 5 years Indefinite Indefinite Indefinite 1 year Current + previous month Indefinite

3.4

RECORD 3.5

MINIMUM DURATION OF RETENTION

Process Analysis and Computer Records 9.5.1 Program Development 9.5.2 Validation Reports 9.5.3 Installation Reports 9.5.4 System Maintenance & Operations

Indefinite Indefinite Indefinite Indefinite

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TITLE Retention Dir ectives for Labor ator y Recor ds Document Number : OP-4.6 Section: Documents and Records

Revision Date: Status: Dr aft Page: 6 of 6

Responsibility Directorate Directors and Team Leaders Supporting Documents Document Name Document # Document Location Establish and periodically review retention directives. Ensure adequate and appropriate storage space is available. Ensures policies and procedures are in compliance with regulations and standards. Retains records and specimens according to established processes. Prepares suitable specimen aliquots for storage.

Quality Officer Laboratory Staff

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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Guidelines for Citing Reference Material Document Number: OP-4.7 Section: Documents and Records Revision Date: Status: Draft 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: Manufacturers product literature such as package inserts and operators manuals; Text books; Published standards and guidelines; Laboratory policy manuals; Unpublished information obtained from experts in the field and Applicable regulations. (1) 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. (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.

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

TITLE: Guidelines for Citing Reference Material Document Number: OP-4.7 Section: Documents and Records

Revision Date: Status: Draft Page: 2 of 2

Supporting statements The following Vancouver style is to be incorporated when citing reference material in laboratory documents: Books with author: Wilson, CRM. Hospital-wide quality assurance models for implementation and development. 1sted. Toronto (ON): W.B. Saunders Company Canada Ltd.; 1978. Book, editor only: Website: Westcott, RT, editor. The certified manager of quality/organizational excellence handbook. 3rd 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: 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 ICON 25hCG 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 Shematek, G, Wood,W. Laboratory safety CSMLS guidelines. 6th 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.

Pamphlet: Package Insert:

Journal Article: CD-ROM:

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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Document Creation, Review and Change Process Template Document Number: OP-4.8 Section: Documents and Records Revision Date: Status: Draft Page: 1 of 1

SECTION A Document Title: Document Number: Requested By: Version Number: Date Initiated: Document Type: Form Policy Procedure 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? Notify Director Yes No

Other

SECTION C

The following activities shall be carried out in the order listed Document Control Process Authority Quality Officer Team Leader Directorate Director Director General

Activity Changes approved Changes approved Changes approved Changes approved (if required)

Initials

Date

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

Non-conformances Responsibility Director General Directorate Directors and Team Leaders

Balances are identified using the unique identifier from the Equipment Inventory Record Each laboratory identifies the calibration status and indicates due date of next calibrations. Balances are operated, maintained and verified by trained personnel using approved processes and procedures. 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. Processes are in place to identify and address non conformances.

Quality Officer

Laboratory Staff

Reviews and approves all Equipment, Reagents and Supplies policies Ensures appropriate resources are available. 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. 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 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.

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

TITLE: Calibration of Balances Document Number: OP-5.1 Section: Equipment, Reagents and Supplies

Revision Date: Status: Draft Page: 2 of 2

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

Prepared by:

Authority:

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: Calibration of Pipettes Document Number: OP-5.2 Section: Equipment, Reagents and Supplies Revision Date: Status: Draft 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 Calibration status Operation Maintenance Pipettes are identified using the unique identifier from the Equipment Inventory Record. Each laboratory identifies the calibration status and indicates due date of next calibrations. Pipettes are operated, maintained and verified by trained personnel using approved processes and procedures. 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. Processes are in place to identify and address non conformances.

Non-conformances

Responsibility Director General Quality Officers Reviews and approves all Equipment, Reagents and Supplies policies Ensures appropriate resources are available. 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. 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

Directorate Director and Team Leaders

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

TITLE: Calibration of Pipettes Document Number: OP-5.2 Section: Equipment, Reagents and Supplies

Revision Date: Status: Draft 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.

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Reagent Water Quality Monitoring Program Document Number: OP-5.3 Section: Equipment, Reagents and Supplies Revision Date: Status: Draft 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. 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 and sanitation, with appropriate documentation, is accomplished using established processes and procedures. Results of testing are maintained and subjected to trend analysis. All non conformances and corrective actions are documented.

Standard

Maintenance

Results

Responsibility Director General Directorate Director and Team Leaders Reviews and approves Reagent Water Quality policy Ensures appropriate resources are available. 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. 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

Quality Officer

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

TITLE: Reagent Water Quality Document Number: OP-5.3 Section: Equipment, Reagents and Supplies

Revision Date: Status: 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.

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

References Clinical and Laboratory Standards Institute (CLSI). Preparation and Testing of Reagent Water in the Clinical Laboratory; Approved GuidelineFourth 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;

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Environmental Monitoring Program Document Number: OP-5.4 Section: Equipment, Reagents and Supplies Revision Date: Status: 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 Non-conformances All documentation is maintained according to the Retention Directives for Laboratory Records policy. Each laboratory has processes to identify and address non conformances.

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

TITLE: Environmental Monitoring Program Document Number: OP-5.4 Section: Equipment, Reagents and Supplies

Revision Date: Status: Draft Page: 2 of 2

Responsibility Director General Quality Officer Laboratory Staff Reviews and approves all Equipment, Reagents and Supplies policies Ensures appropriate resources are available. 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. 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 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.

Directorate Director and Team Leaders

Supporting Documents Document Name Equipment, Reagents and Supplies Retention of Records and Diagnostic Material Nonconforming Laboratory Events Laboratory Nonconforming Event Report Form References CAN/CSA-Z15189-07 Medical Laboratories-Particular Requirements for Quality and Competence; 5.2.5 Document # QP-1.2.4 OP-4.6 OP-8.2.1 OP-8.2.2 Document Location Quality Manual Quality Manual Quality Manual Quality Manual

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Handling, Storage and Transport of Equipment, Reagents and Supplies Document Number: OP-5.5 Section: Equipment, Reagents and Supplies Revision Date: Status: Draft Page: 1 of 2

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 manufacturers recommendations or internal standards to ensure quality during use, repair or transport. 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. EHNRI ensures that equipment sent out from the laboratory is functioning correctly before being put back in service. Staff receive training on the safety features of equipment operations and the handling and storage of associated chemicals. Appropriate safety precautions are observed by staff when handling, storing, transporting or disposing of equipment, reagents and supplies.

Removing from service

Returning to service

Staff training

Safety

Responsibility

Director General Directorate Directors and Team Leaders

Reviews and approves policy Ensures appropriate resources are available Ensure that processes, procedures and documentation are performed Review revised or changed documents Notifies laboratory personnel of revisions or changes to this policy

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

TITLE: Handling, Storage and Transport of Equipment, Reagents and Supplies Document Number: OP-5.5 Section: Equipment, Reagents and Supplies Quality Officer Laboratory Staff Supporting Documents

Revision Date: Status: Draft Page: 2 of 2 Ensures policies and procedures are in compliance with regulations, standards and manufacturers instructions. Review all non conformances and determines corrective action 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 Equipment, Reagents and Supplies Retention Directives for Laboratory Records and Diagnostic Material References

Document # QP-1.2.4 OP-4.10

Document Location Quality Manual Volume 1 Quality Manual Volume 1

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.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

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

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

TITLE: Medical Device and Product Alerts Document Number: OP-5.6 Section: Equipment, reagents and Supplies

Revision Date: Status: 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 Reporting EHNRI provides training to staff responsible for investigating alerts. 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 Directorate Directors and Team Leaders Laboratory Staff Reviews and approves new or changed policy Communicates with clients affected by product alerts 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 Receives alert notifications in the absence of the Team Leader Provides an annual report on alerts for the Quality Council Participates in alerts investigations Completes required documentation

Quality Officer

Supporting Documents Document Name Equipment, Reagents and Supplies Retention Directives for Laboratory Records and Diagnostic Material Alert Response Plan Process Medical Device and Product Alerts Response Plan Report Template Document # QP-1.2.4 OP-4.6 OP-4.12 OP-4.13 Document Location Quality Manual Quality Manual Quality Manual Quality Manual

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

TITLE: Medical Device and Product Alerts Document Number: OP-5.6 Section: Equipment, reagents and Supplies References

Revision Date: Status: Page: 3 of 3

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 1-56238-5909). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 190871898 USA, 2005.

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Centrifuge Management Program Document Number: OP-5.7 Section: Equipment, Reagents and Supplies Revision Date: Status: Draft 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 Installation Centrifuges are procured using approved processes and guidelines. 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. Operators receive training on centrifuge operating principles, hazards, best practices, maintenance and troubleshooting. 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. 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. A replacement program is developed to ensure centrifuges are replaced as required.

Training

Operation

Maintenance

Replacement

Responsibility Director General, or designee Reviews and approves all Equipment, Reagents and Supplies policies Ensures appropriate resources are available. Oversee the approved centrifuge management program. Ensure that processes, procedures and documentation related to the centrifuge program are performed.

Directorate Directors and Team Leaders

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

TITLE: Centrifuge Management Program Document Number: OP-5.7 Section: Equipment, Reagents and Supplies Quality Officer Laboratory Staff Supporting Documents Document Name Equipment, Reagents and Supplies Retention of Records and Diagnostic Material Nonconforming Laboratory Events Laboratory Nonconforming Event Report Form Centrifuge Operating Procedure Centrifuge Guidelines and Checklists

Revision Date: Status: Draft Page: 2 of 2

Review revised or changed documents Develop a replacement program Notifies laboratory staff of revisions or changes to this policy. Ensures compliance with standards, policies, procedures and manufacturers instructions. Review all non conformances and determines corrective action 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 # QP-1.2.4 OP-4.10 OP-11.B.2 OP-11.B.4 pending pending

Document Location Quality Manual Quality Manual Quality Manual Quality Manual

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.

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Laboratory Path of Wor kflow Document Number : OP-6.1.1 Section: Pr ocess Contr ol Pr e-Analytical Pur pose 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 Path of Wor kflow 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 EHNRIs 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 EHNRIs best contribution to quality patient care and effective Public Health Emergency Management. EHNRI applies Quality System Essentials (QSEs) to manage the path of workflow to ensure quality and patient safety. Revision Date: Status: Dr aft Page: 1 of 3

the

Quality System Essentials (QSEs)

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TITLE: Labor ator y Path of Wor kflow Document Number : OP-6.1.1 Section: Pr ocess Contr ol Pr e-Analytical

Revision Date: Status: Dr aft Page: 2 of 3

EHNRI Labor ator y Path of Wor k Flow

Customer Laboratory Services

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

Analytical
Specimen Testing Results Review and Interpretation

Post-Analytical
Results Report Results Archiving Specimen Management

Information Management
Lab Information System (LIS) Statistics

PATHS

OF

WORKFLOW

Quality System Essentials: Foundations that apply to all operations in the path of workflow
The Labor ator y Organization Personnel Equipment Purchasing and Inventory Facilities and Safety The Work Process Control Documents and Records Information Management The Measur ements Assessments Process Improvement Occurrence Management Customer Satisfaction

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

TITLE: Labor ator y Path of Wor kflow Document Number : OP-6.1.1 Section: Pr ocess Contr ol Pr e-Analytical

Revision Date: Status: Dr aft Page: 3 of 3

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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Specimen Acceptance and Rejection Document Number: OP-6.1.2 Section: Process Control Pre-Analytical Revision Date: Revision: Draft 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 patients report to indicate the nature of the problem.

Definitions Irretrievable: Difficult or impossible to retrieve or repeat

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

TITLE: Specimen Acceptance and Rejection Document Number: OP-6.1.2 Section: Process Control Pre-Analytical Supporting statements

Revision Date: Revision: Draft Page: 2 of 4

Specimen Labelling 1. Specimens are clearly identified with a legible patients legal name and a Requirements 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. Drivers 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. Specimens are accompanied by a requisition as per the requirements stated in the Requisition Policy. Specimens are transported as per requirements stated in the Transport of Specimens Policy. Specimens are received and processed in the laboratory within prescribed timelines for collection/centrifugation/processing as established by each laboratory division. Each laboratory division establishes specimen rejection criteria and procedures appropriate for the individual test requirements. 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 laboratorys policies. 1.5. When compromised or irretrievable specimens are accepted for processing, a signature must be obtained from the person responsible for specimen collection.

Requisition Transportation Requirements Receipt/Handling

Rejection Criteria Exceptions

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

TITLE: Specimen Acceptance and Rejection Document Number: OP-6.1.2 Section: Process Control Pre-Analytical

Revision Date: Revision: Draft Page: 3 of 4

Responsibility Director General Directorate Directors and Team Leader Reviews and approves policy. Ensure staff receives specimen acceptance and rejection training. Review, revise and implement the policy. Review and approve the Specimen Collection Handbook. Ensures compliance with policies, standards Monitors quality indicators and works with Team Leader and staff on process improvement. 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.

Quality Officer

Laboratory Staff

Supporting Documents Document Name Mislabelled/unlabelled Laboratory Specimens for Diagnostic Testing Specimen Collection Manual or Handbook Specimen Collection Process Accidental Exposure to Blood and/or Potentially Infectious Body Substances Microbiology Specimen Rejection Policy Accessioning User Reference Manual Sample Integrity and Rejection Policy Interacting and Handling Medical-Legal Samples/Requests CHE-10-002 Internal Audit Reporting Policy Specimen Collection Policy TTS-P700.302 Specimen Adequacy A.1.3 Hemolyzed Blood Samples, Management of CC 85-026 Document # pending pending pending pending pending pending pending pending pending pending pending pending Document Location

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TITLE: Specimen Acceptance and Rejection Document Number: OP-6.1.2 Section: Process Control Pre-Analytical

Revision Date: Revision: Draft Page: 4 of 4

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.

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Specimen Label Requirements Document Number: OP-6.1.3 Section: Quality Manual Revision Date: Revision: 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 patients 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. 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 All specimen aliquots, portions and slides are traceable to the original requisition and specimen. Slides are labelled as outlined in section 1.0 and the date of collection (time is not required). Specimens not meeting the minimum labeling requirements as stated above may be accepted according to the Specimen Acceptance and Rejection policy

Label Placement

Aliquot Labels Slides Exceptions

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

TITLE: Specimen Label Requirements Document Number: OP-6.1.3 Section: Quality Manual

Revision Date: Revision: Page: 2 of 2

Responsibility Director General Directorate Director and Team Leader Quality Officer Reviews and approves policy Ensures staff receive specimen labeling training Reviews and revises policy Ensures compliance with policies, standards Monitors quality indicators and works with Team Leader and staff on process improvement. 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

Laboratory Staff

Supporting Documents Document Name Process for Mislabelled Laboratory Specimens for Diagnostic Testing. Unlabeled Laboratory Specimens for Diagnostic Testing. Specimen Collection Manual Specimen Collection Process. Microbiology Specimen Rejection Policy. Specimen Collection Policy Specimen Receipt, Centrifugation, Separation, Labelling and Storage Specimen Acceptance and Rejection 6.1.2 Rejected Sample Report Sample Integrity and Rejection Policy Document # OP-6.1.4 pending pending pending pending pending pending pending pending pending Document Location

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.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Process for Mislabeled/Unlabeled Specimens Document Number: OP-6.1.4 Section: Process Control Pre-Analytical Revision Date: Status:Draft 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

Retrievable Irretrievable

A mislabeled or unlabeled specimen is received in the Laboratory. (Patient Misidentification) Refer to list of Irretrievable specimens for each division YES Mislabeled 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 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 Unlabeled

Is the specimen NO

Mislabeled

Unlabeled

Notify the patient care area to inform them of the rejection

o Receive and cancel the specimen in the LIS system or Log Book o Document the communication in the LIS using standardized LIS comments Patient Safety or Lab Nonconformance Report filed

Document the compromised sample and who identified using standardized LIS comments

NOTE: This is a CONTROLLED document for inter nal use only.

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Labor ator y Test Utilization Document Number : OP-6.1.5 Section: Pr ocess Contr ol Pr e-Analytical Revision Date: Status: Dr aft Page: 1 of 3

Pur pose 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 EHNRIs Management.

Suppor ting Statements Intr oduction 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. 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. 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

Change in Availability

Test

Monitor ing Utilization

Test

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

TITLE: Labor ator y Test Utilization Document Number : OP- 6.1.5 Section: Pr ocess Contr ol Pr e-Analytical NOTE:

Revision Date: Status: 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 laboratorys Specimen Rejection Policy. Prepare a report and send to those concerned.

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 Directorate Directors and Team Leaders Reviews and approves the policy Allocates and approves resources 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 Reviews and revises related operational policies when additions or changes to LIS Rules occur 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

Quality Officer Laboratory Informatics Group

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

TITLE: Labor ator y Test Utilization Document Number : OP- 6.1.5 Section: Pr ocess Contr ol Pr e-Analytical

Revision Date: Status: Page: 3 of 3

Supporting Documents Document Name Physicians Laboratory Handbook (Test Menu) Document # Document Location

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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Retention Dir ectives for Diagnostic Mater ials Document Number : OP-6.1.6 Section: Pr ocess Contr ol Revision Date: Status: Dr aft Page: 1 of 4

Pur pose 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. 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. Stor age Requir ements 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. 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. Specimens collected for medico-legal purposes may have separately specified retention requirements

Retention Guidelines

Retention Limitations

Medico-legal r equir ements

Retention Times:
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TITLE Retention Dir ectives for Diagnostic Mater ials Document Number : OP-6.1.6 Section: Documents and Recor ds

Revision Date: Status: Dr aft 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 Until testing completed + 2 days Discard after specimen verified 2 days 5 year 2 days 2 days 1 year + current year

1.1

Urine Specimens 1.1.1 Aliquots of 24-hr urine (2-8C) 1.1.2 Routine urinalysis 1.1.3 Urine for pregnancy testing Blood gas results generated from instruments not interfaced and require manual LIS input Routine serum/plasma (2-8C) CSF and body fluids (2-8C) Instrument calibration Records

1.2 1.3 1.4 1.5

2.0

HEMATOLOGY
MATERIAL MINIMUM DURATION OF RETENTION 2 days 2 days 20 years 20 years 1 year 7 days 1 year

2.1 2.1.1 2.1.2 2.2 2.3 2.4 2.5

Blood Specimens Coagulation (2-8C) EDTA bloods (2-8C or RT) Bone Marrow Reports Bone Marrow Slides

Peripheral Blood Smear 2.4.1 Abnormal (room temperature) 2.4.2 Normal (room temperature) Special Test Booking Dates

3.0

MICROBIOLOGY
RECORD/MATERIAL MINIMUM DURATION OF RETENTION

3.1

Original Specimen 3.1.1 3.1.2 3.1.3 3.1.4 Blood culture vials Non-sterile specimen (RT) Plates with growth or no visible growth (RT) SAF stools (RT) After final activity report (FAR) checked Discard according to SOP After FAR checked 2 weeks after final report

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TITLE Retention Dir ectives for Diagnostic Mater ials Document Number : OP-6.1.6 Section: Documents and Recor ds
3.1.5 3.1.6 3.1.7 3.1.8 3.2

Revision Date: Status: Dr aft Page: 3 of 4

3 weeks 2 weeks 8 weeks 1 month frozen

Skin scrapings (RT) Sterile fluids, referred-in identification specimens, blood transfusion specimens (4C) TB sediments (4C) Tissue and CSF (-20C)

Positive Isolates 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8 3.2.9 3.2.10 3.2.11 3.2.12 3.2.13 MSRA, VRE, ESBL, Amp C, H. influenza, S. pneumoniae, N. meningitidis (-70C) Significant isolates from blood cultures, CSF, intraocular and transfusion specimens (-70C) Enteric pathogens (RT) N. gonorrhoeae (-70C) H. pylori (-70C) M. tuberculosis (-70C) Non-tuberculosis mycobacterium (-70C) Yeast isolates resistant to fluconazole (-70C) Nocardia species (-70C) All survey and referred-in isolates (-70C) Dimorphic fungi (-70C) Mycology isolates-genus level (RT) Mycology isolates-speciated (RT) 1 year 1 year 1 year 1 year 1 year 10 years 1 year 1 year 1 year 1 year 1 year 1 month after FARs are checked

3.3

Virology 3.3.1 3.3.2 3.3.3 3.3.4 Original tissue (-70C) Routine specimen (4C) Positive specimen Positive isolates and 1st positive passage (-70C) 3.3.5 Slides (RT) Immunology 3.4.1 3.4.2 Original specimen/whole blood (4C) Aliquot (4C) 1 month 2 weeks after final report 1 year 1 year 1 week after final report 1 week after final report 2 weeks after final report

3.4

4.0

TRANSFUSION SERVICE
MATERIAL MINIMUM DURATION OF RETENTION 14 days 30 days

9.6

Blood Specimens 9.6.1 Routine specimens 9.6.2 Pre-admission specimens

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TITLE Retention Dir ectives for Diagnostic Mater ials Document Number : OP-6.1.6 Section: Documents and Recor ds

Revision Date: Status: Dr aft Page: 4 of 4

Responsibility Directorate Directors and Team Leaders Establish and periodically review retention directives. Ensure adequate and appropriate storage space is available. Ensures policies and procedures are in compliance with regulations and standards. Retains specimens according to established processes. Prepares suitable specimen aliquots for storage.

Quality Officer Laboratory Staff

Supporting Documents 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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Technical Procedures (SOPs) Document Number: OP-6.2.1 Section: Process Control - Analytical Revision Date: Status: Draft 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 EHNRIs 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. 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.
NOTE: This is a CONTROLLED document for internal use only.

Content

TITLE: Technical Procedures (SOPs) Document Number: OP-6.2.1 Section: Process Control - Analytical

Revision Date: Status: Draft Page: 2 of 7

2. Manufacturers 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. All procedures developed in-house must be validated for their intended use. Each technical procedure is reviewed for accuracy and approved with the signature of the authorizing person prior to 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. 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. 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. 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.

Validation Approval Implementation

Review Process

Document Management System

Client Access

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

TITLE: Technical Procedures (SOPs) Document Number: OP-6.2.1 Section: Process Control - Analytical

Revision Date: Status: Draft Page: 3 of 7

Responsibility Director General Directorate Directors and Team Leaders Quality Officers Laboratory Staff Review, revise and approve technical procedures Communicate significant changes to clients 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 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. Identifies the need for development or revision of technical procedures Writes technical procedures as assigned Reviews and revises technical procedures Follows approved technical procedures

Supporting Documents Document Name Training and Initial Competency Competency Assessment Program Technical Procedure Template Retention Directives for Laboratory Records and Diagnostic Materials Review of Technical Procedure Manuals Document # OP-3.2 OP-3.3 OP-4.4 OP-4.6 OP-8.2 Document Location Quality Manual Quality Manual Quality Manual Quality Manual 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 GuidelineFifth 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

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TITLE: Technical Procedures (SOPs) Document Number: OP-6.2.1 Section: Process Control - Analytical

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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 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 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

Abbreviations

Materials

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
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Time and

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container type Limitations: Hemolysis, lipemia, interfering substances, etc. Sample retention: Samples are discarded after __ days.

temperature

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 Name, manufacturer, number

Level Stability Time and temperature

Frequency

Preparation (y/n)

Calibrator preparation: Step-by-step instructions for calibrator preparation Note: Shall include troubleshooting required when expected results are not achieved. Quality Control Control Name, manufacturer, number Control preparation: Step-by-step instructions for control preparation
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Level Stability Time and temperature

Frequency

Preparation (y/n)

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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 Male Female Toxic range Analytical Range Units

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.

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TITLE: Technical Procedures (SOPs) Document Number: OP-6.2.1 Section: Process Control - Analytical

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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 Operators Manual Forms Worksheet

Reference

List all references used to create document.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Method Validation Guidelines Document Number: OP-6.2.2 Section: Process Control - Analytical Revision Date: Status: Draft 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 laboratorys requirements or the manufacturers 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 manufacturers 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 manufacturers 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
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TITLE: Method Validation Guidelines Document Number: OP-6.2.2 Section: Process Control - Analytical

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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 manufacturers 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. 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 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. Documentation of validation studies, including the data, is maintained according to EHNRIs Retention Directives for Laboratory Records and Diagnostic Material policy.

Scheduling

Validation Process

Record Retention

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TITLE: Method Validation Guidelines Document Number: OP-6.2.2 Section: Process Control - Analytical

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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 Develop method validation protocols Investigate and resolve discrepant results Retain appropriate documents and data Participates in the validation process as assigned

Directorate Directors and Team Leaders

Quality Officers

Laboratory Staff

Supporting Documents Document Name Method Validation Process Validation Protocol Template Validation Discrepancy Report Template Retention Directives for Laboratory Records and Diagnostic materials Linearity Procedure Precision Procedure Method Comparison 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 Document # OP-8.8 OP-8.9 OP-8.10 OP-4.6 pending pending pending Document Location Quality Manual Quality Manual Quality Manual Quality Manual

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Reference Ranges Document Number: OP-6.2.3 Section: Process Control - Analytical 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. 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. Revision Date: Status: Draft Page: 1 of 3

Client Notification

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TITLE: Reference Ranges Document Number: OP-6.2.3 Section: Process Control - Analytical Process for Establishing a Reference Range: STEP 1. Define the analyte 2. Define the method

Revision Date: Status: Draft Page: 2 of 3

3. 4.

Define pre-analytical factors Define the principle

5. Describe the data sources

6.

Define partitioning

7. Define number of significant figures 8. Define clinical significance

9. Decision and implementation

PROCESS Include a brief description of the analyte, the clinical utility, biological variation and major variations in form. 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. Document any important pre-analytical considerations together with any actions taken in response to the interference. Document the principle behind the reference interval (i.e. 95% confidence limit) and make available to clients if required. Document the data sources including number of subjects, nature of subjects (how defined), important exclusions, relevant preanalytical factors, statistical measures, outliers excluded, analytical method and traceability of method. Document considerations of partitioning based on sex and age etc. including when partitioning is not performed. State the degree of rounding of the reference range limits with the reasons for the conclusions. 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. 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 Assists in study as assigned Analyzes specimens and collates data

Directorate Directors and Team Leaders Laboratory Staff

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TITLE: Reference Ranges Document Number: OP-6.2.3 Section: Process Control - Analytical

Revision Date: Status: Draft Page: 3 of 3

Supporting Documents
Document Name Reference Ranges All Labs Document # Document Location

pending

References NCCLS. How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved GuidelineSecond 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.

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Cr itical Results Repor ting Document Number : OP-6.3.1 Section: Pr ocess Contr ol Post-Analytical Revision Date: Status: Dr aft 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 Reporting Critical Values Critical test values are defined by the policies of each laboratory division and are posted for individual tests in the technical manuals. 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.
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TITLE: Cr itical Results Repor ting Document Number : OP-6.3.1 Section: Pr ocess Contr ol Post-Analytical

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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 Directorate Director and Team Leader

Quality Officer

Collaborate with medical staff to define critical values Review and revise related policies, processes and procedures 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
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 Release of Laboratory Report Critical Results Procedure, Chemistry Critical Results Procedure, Hematology Critical Laboratory Values 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. Document # pending pending pending pending Document Location

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Cr itical Values Document Number : OP-6.3.2 Section: Pr ocess Contr ol Post-Analytical Revision Date: Status: Dr aft Page: 1 of 2

Pur pose 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 Cr itical 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. 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. EHNRI annually reviews the listing of critical tests, critical values and critical specimens and makes appropriate changes when required.

Notification

Review

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 Ensures compliance with policies, standards Monitors quality indicators and works with Team Leader and staff on process improvement.

Quality Officer

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TITLE: Cr itical Values Document Number : OP-6.3.2 Section: Pr ocess Contr ol Post-Analytical

Revision Date: Status: Dr aft Page: 2 of 2

Supporting Documents Document Name Critical Results Reporting Document # 6.3.1 Document Location Quality Manual Volume 2

Refer ences 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

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

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Discr epant and Corr ected Results Document Number : OP-6.3.3 Section: Pr ocess Contr ol Post-Analytical Revision Date: Status: Dr aft Page: 1 of 2

Pur pose 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 Discr epant / Cor r ected 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. 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. 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.

Tr aceability of Cor r ected Results

Notification of Cor r ected Results

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TITLE: Discr epant and Corr ected Results Document Number : OP-6.3.3 Section: Pr ocess Contr ol Post-Analytical

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Responsibility Quality Officer

Directorate Directors and Team Leaders

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 Ensures compliance with policies, standards Monitors quality indicators and works with Team Leader and staff on process improvement.

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

Supporting Documents Document Name Final Report Retention Directives for Laboratory Records and Diagnostic Materials Document # OP 6.3.4 OP-4.6 Document Location Quality Manual Quality Manual

Refer ences 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 GuidelineThird Edition. NCCLS document GP26-A3 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Final Report Document Number : OP-6.3.4 Section: Pr ocess Contr ol Post-Analytical Revision Date: Status: Dr aft Page: Page 1 of 2

Pur pose 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. The content and format of all generated patient reports is reviewed, revised, if required, and approved by the Director on a regular basis. 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. Final reports are maintained by EHNRI as outlined in Section 1.10 of the Retention Directives for Laboratory Records and Diagnostic Materials policy.

Repor t Review

Gener ating Repor t

Recor d Retention

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TITLE: Final Report Document Number : OP-6.3.4 Section: Pr ocess Contr ol Post-Analytical

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Responsibility Director General Directorate Director Team Leader Quality Officer Reviews and approves policy 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 Ensures compliance with policies, standards Monitors quality indicators and works with Team Leader and staff on process improvement. Build new or make changes to the existing final report format

Laboratory Information System (LIS) Database Coordinators

Supporting Documents Document Name Retention Directives for Laboratory Records Release of Laboratory Report Document # OP-4.6 Document Location Quality Manual Quality Manual

pending

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.

NOTE: This is a CONTROLLED document for internal use only

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Internal Quality Control Program Document Number: OP-7.1 Section: Quality Assurance Revision Date: Status: Draft 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. Manufacturers 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

Quantitative tests

A positive and negative control shall be run according to the manufacturers 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. 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.

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TITLE: Internal Quality Control Program Document Number: OP-7.1 Section: Quality Assurance

Revision Date: Status: Draft Page: 2 of 3

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 Reagents of 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. 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. 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.

QC Tracking Mechanisms

Corrective Action

Definitions and Abbreviations QC Quality control SOP Standard Operating Procedures

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TITLE: Internal Quality Control Program Document Number: OP-7.1 Section: Quality Assurance

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Responsibility Director General Directorate Directors Team Leaders

Quality Officers

Reviews and approves IQC policies Ensure IQC programs are in place Review and approve discipline specific QC policies, processes and procedures Review monthly QC reports and initiate corrective action plans as appropriate 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 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
Adhere to IQA policies, processes and procedures Analyze the IQA material

Laboratory Staff

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 Process Control Policy Shipment Acceptance Verification) Policy Shipment Acceptance Process

Document # QP-1.2.5 (Supply pending pending

Document Location Quality Manual

References ISO 15189:2003 - Medical laboratories: particular requirements for quality and competence

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: External Quality Assessment Program Document Number: OP-7.2 Section: Quality Assurance Revision Date: Status: Draft 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 EHNRIs 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 The frequency of the program shall be determined by the EQA provider(s) and at least annually 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. 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. 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 Laboratories must meet the proficiency acceptance criteria required by the EQA provider. The laboratory shall act upon and document problems or deficiencies identified by EQA programs by completing a

Frequency of use

Processing of EQA Samples

EQA Tracking Mechanisms

Communication of results

Acceptance Criteria Remedial/Corrective/Preventive Action

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TITLE: External Quality Assessment Program Document Number: OP-7.2 Section: Quality Assurance

Revision Date: Status: Draft Page: 2 of 4

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. 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.

Process for follow-up unacceptable results

on

Definitions EQA External quality assurance PT Proficiency testing

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TITLE: External Quality Assessment Program Document Number: OP-7.2 Section: Quality Assurance

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Responsibility Director General Directorate Directors Team Leaders

Reviews and approves EQA policies

Quality Officers

Laboratory Staff

Ensure the development and implementation of EQA programs Reviews EQA results and communicates to staff 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 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 Adhere to EQA policies, processes and procedures Analyze the EQA material Give EQA results to the technical specialists for review and collation

Supporting Documents
Document Name Process Control Policy Nonconforming Laboratory Events External Quality Assessment (EQA) Management Form Process for Managing External Quality Assessment Programs Retention Directives for Laboratory Records and Diagnostic Material Document # QP-1.2.5 OP-8.2.1 pending OP-7.6 OP-4.6 Document Location Quality Manual Quality Manual

Quality Manual Quality Manual

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
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TITLE: External Quality Assessment Program Document Number: OP-7.2 Section: Quality Assurance

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Appendix 1 External Quality Assessment Service Providers

Anatomical Pathology AccuTrak Centre (Benchmarking) Beckman Instruments (Benchmarking) Bio-Rad Laboratories Canadian Immunohistochemistry Survey Cancer Centre Prevention Program CALA CMPT CAP Health Metrx Canada Interlaboratory Quality Assurance Program (Benchmarking) Laboratoire de Sant Publique du Qubec National Laboratory for HIV Immunology National Laboratory for HIV Reference Services National Microbiology Laboratory NRCM NWRI Ontario Ministry Her2 QA program Public Health Agency of Canada QMP-LS St. Joseph's Healthcare Charlton Campus Tech Chek UCLA International HLA DNA Exchange UK NEQAS Viral EQA (NML) Viral EQA (CDC) Toxicology HLA Flow Cytometry Molecular Molecular Environmental Cytology Environmental Environmental Malaria Slides Flow Cytometry Malaria Slides HIV Virology Vir/Mol Blood Transfusion Chemistry Hematology Immunology Microbiology Community Labs

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Planning and Selection of Quality Contr ol Rules and Pr ocedur es Document Number : OP-7.3 Section: Quality Assur ance 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: Status: Dr aft Page: 1 of 5

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TITLE: Planning and Selection of Quality Contr ol Rules and Pr ocedur es Document Number : OP-7.3 Section: Quality Assur ance

Revision Date: Status: Dr aft Page: 2 of 5

Supporting Statements Quality Requirements Precision and Accuracy Quality Control (QC) Procedures
Laboratories define quality requirements for each laboratory test; when applicable, specifications are based on total allowable error (TEa), medical applications and biological variation 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. 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 Sigmametrics 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. 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. 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. 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)

Total Quality Control Strategy (TQC)

QC Rules Review

Five Quality Components

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TITLE: Planning and Selection of Quality Contr ol Rules and Pr ocedur es Document Number : OP-7.3 Section: Quality Assur ance

Revision Date: Status: Dr aft Page: 3 of 5

Responsibility Director General Directorate Directors Laboratory Staff Reviews and approves quality policies Allocate and approve resources 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 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 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

Team Leader/Quality Officers

Supporting Documents Document Name Process Control Policy Internal Quality Control Program Establishing Target Values for Quality Control Continuous Quality Improvement Document # QP-1.2.5 OP-7.1 OP-7.4 OP-8.1.1 Document Location Quality Manual Quality Manual Quality Manual Quality Manual

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TITLE: Planning and Selection of Quality Contr ol Rules and Pr ocedur es Document Number : OP-7.3 Section: Quality Assur ance

Revision Date: Status: Dr aft Page: 4 of 5

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 GuidelineSecond 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 GuidelineThird Edition. CLSI document C24-A3 (ISBN 156238-613-1). 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

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TITLE: Planning and Selection of Quality Contr ol Rules and Pr ocedur es Document Number : OP-7.3 Section: Quality Assur ance

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APPENDIX 1: Process for planning and selecting QC rules and procedures

P lanning:

Q Q
I mprovement:
Initiate changes when needed

Define quality requirements

Q
Q uality G oal:
QC Rules/Procedures

Q
T eamwork:
Design TQC strategies

R eview:
Assess QC data/records

M onitoring:
Measure QC indicators

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Establishing Target Values for Quality Control Document Number: OP-7.4 Section: Quality Assurance Revision Date: Status: Draft 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

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TITLE: Establishing Target Values for Quality Control Document Number: OP-7.4 Section: Quality Assurance

Revision Date: Status: Draft Page: 2 of 2

Responsibility
Director General Directorate Directors and Team Leaders Quality Officers Reviews and approves QC policies Ensures appropriate resources are available Reviews QC data Approves QC target values and ranges Determine/calculates target values, ranges, CV, SD data from QC material Plan parallel testing for QC material Analyzes QC material as assigned for statistical data Runs QC material in parallel testing

Laboratory Staff

Supporting Documents Document Name Process Control Policy Internal QC Program Planning and Selection of Quality Control Rules and Procedures Document # QP-1.2.5 OP-7.1 OP-7.3 Document Location Quality Manual Quality Manual Quality Manual

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.

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Documentation and Review of Quality Control Document Number: OP-7.5 Section: Quality Assurance Revision Date: Status: Draft 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.

Supporting statements
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. Training on QC interpretation and corrective/preventive action is provided to all staff upon hire and on a recurring basis. 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. 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.

Staff Training QC Failure

POCT QC

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TITLE: Documentation and Review of Quality Control Document Number: OP-7.5 Section: Quality Assurance

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Responsibility
Director General Directorate Directors and Team Leaders Reviews and approves QC policies Ensures appropriate resources and training are available 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 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 Analyzes QC material as assigned for statistical data Informs appropriate personnel of unacceptable QC results

Quality Officers

Laboratory Staff

Supporting Documents Document Name Process Control Policy Internal QC Program Planning and Selection of Quality Control Rules and Procedures Retention Directives for Laboratory Records and Diagnostic Material Root Cause Analysis Corrective and Preventive Actions 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. Document # QP-1.2.5 OP-7.1 OP-7.3 OP-4.6 pending pending Document Location Quality Manual Quality Manual Quality Manual Quality Manual

CAN/CSA 15189:03 - Medical laboratories: particular requirements for quality and competence, 5.6.1-3.

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Pr ocess for Managing Exter nal Quality Assessment Pr ogr ams Document Number : OP 7.6 Section: Quality Assur ance Revision Date: Status: Dr aft Page: 1 of 2

Pur pose This process delineates the activities involved for managing external quality assessment schemes. Suppor ting Documents Document Name Assessments: Internal & External External QC Program Nonconforming Laboratory Events Document # QP-1.2.8 OP-7.2 OP-8.2.1 Document Location Quality Manual Quality Manual 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: Pr ocess for Managing Exter nal Quality Assessment Pr ogr ams Document Number : OP 7.6 Section: Quality Assur ance

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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

5.

Results from all participating laboratories analyzed and a report prepared

4.

Results of the examination returned to the External Quality Assessment PROVIDER

6.

Report indicating the performance of the laboratorys results in relation to the performance of all participating laboratories sent to EHNRI laboratory

7.

EHNRI laboratorys reviews its performance in relation to the performance of all participating laboratories and takes action to remedy any problems

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Continuous Quality Improvement Document Number: OP-8.1.1 Section: Process Improvement Revision Date: Status: Draft 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). 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 services compliance with standards.
NOTE: This is a CONTROLLED document for internal use only.

CQI Strategies

TITLE: Continuous Quality Improvement Document Number: OP-8.1.1 Section: Process Improvement

Revision Date: Status: Draft Page: 2 of 5

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.

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TITLE: Continuous Quality Improvement Document Number: OP-8.1.1 Section: Process Improvement

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S
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 The Performance Improvement Plan

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TITLE: Continuous Quality Improvement Document Number: OP-8.1.1 Section: Process Improvement Responsibility Director General

Revision Date: Status: Draft Page: 4 of 5

Directorate Directors / Team Leaders and Quality Officer

Laboratory Staff

Reviews and approves quality policies Approves new and revised CQI policies and processes Leads the accreditation process 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 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

Supporting Documents
Document Name Document # QP-1.2.9 Process Improvement QP-1.2.10 Client Service and Satisfaction Retention Directives for Laboratory Records OP-4.6 Document Location Quality Manual Quality Manual Quality Manual Quality Manual Quality Manual

and Diagnostic Material Continuous Quality Improvement Process Quality Improvement Plan Template

OP-8.1.2 OP-8.1.3

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TITLE: Continuous Quality Improvement Document Number: OP-8.1.1 Section: Process Improvement References

Revision Date: Status: Draft Page: 5 of 5

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-CheckAct 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

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Continuous Quality Improvement Process Document Number: OP-8.1.2 Section: Process Improvement 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. Revision Date: Status: Draft Page: 1 of 2

Quality Indicator: Defined data to monitor the quality system.

Supporting Documents

Document Name Process Improvement Continuous Quality Improvement

Document # QP-1.2.9 OP-8.1.1

Document Location Quality Manual Quality Manual

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TITLE: Continuous Quality Improvement Process Document Number: OP-8.1.2 Section: Process Improvement

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EVALUATION activities include:

o RESOLUTION OF COMPLAINTS o INTERNAL AUDIT o ASSURING THE QUALITY OF EXAMINATIONS (particularly participation in external quality assessments) and

CORRECTIVE ACTION
Potential non conformances
Non conformances Review non conformances Determine the root causes of non conformances

PREVENTIVE ACTION
Review laboratory data and information to determine where potential non conformances exist

Potential non conformances

Determine the root causes of potential non conformances

Evaluate the need for corrective action to ensure non conformances do not re-occur

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 Record the results of corrective action taken Determine and implementing corrective action taken

Evaluate the need for preventive action to ensure that non conformances do not occur Determine and implement preventive action taken Record the results of preventive action taken

Review the effectiveness of corrective action taken

Review the effectiveness of preventive action taken

CONTINUOUS QUALITY IMPROVEMENT

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Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Quality Improvement Plan Template Document Number: OP-8.1.2 Section: Quality System Essential NOTE: See Appendix I for explanation of Sections. <INSERT EHNRI HEADER> QUALITY IMPROVEMENT PLAN Quality Improvement Plan Name: Author: Date Revision Date: Status: Draft Page: 1 of 3

Team Members:

Purpose of Improvement:
WHAT ARE WE TRYING TO ACCOMPLISH?

Scope:

Improvement Objectives:

TITLE: Quality Improvement Plan Template Document Number: OP-8.1.2 Section: Quality System Essential
Measur es 1. 2. 3. 4. 5. 6.

Revision Date: Status: Draft Page: 2 of 3

Cur r ent Per fo rmance Goal

HOW WILL WE KNOW A CHANGE IS AN IMPROVEMENT? WHAT CHANGES CAN WE MAKE THAT WILL RESULT IN IMPROVEMENT?
HOW WILL WE MANAGE THE IMPROVEMENT PROJECT?

Change Concept to Implement

Individual Roles & Responsibilities

Communication Str ategy

Review Schedule

Risks

TITLE: Quality Improvement Plan Template Document Number: OP-8.1.2 Section: Quality System Essential

Revision Date: Status: Draft Page: 3 of 3

Appendix 1 Performance Improvement Plan Guidelines for Completion

The name of the process improvement or quality initiative.

Performance Improvement Plan Name

Team Members A listing of the people (and respective areas of expertise) that have allocated time to assist with the project. 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. Are there constraints or limitations within the purpose of the improvement? What is the team responsible for, what are they not responsible for? A specific statement of a desired short-term condition or achievement. Data that will indicate if the improvement had its desired effect. It must include current information, as well as a goal. A list of changes instituted for improvement. A detailed listing of Team Members responsibilities. This will ensure proper accountability and structure. This section outlines the tools and processes used to communicate process improvement information. This section is key to making the process improvement plan manageable by clearly defining the dates and deliverables for the quality initiative. Potential risks associated to the improvement plan (or not doing the plan).

Purpose of Improvement

Scope

Improvement Objective

Measures

Change Concepts to Implement Individual Roles & Responsibilities Communication Strategy Review Schedule

Risks

Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia

TITLE: Nonconforming Laboratory Events Document Number: OP-8.2.1 Section: Occurrence management

Revision Date: Status: Draft 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 1. Action Develop the Laboratory Nonconforming Event Reporting Process: The Director, in collaboration with Team Leaders, will initiate and maintain the Laboratory Nonconforming Event Reporting Process. Develop and maintain an event investigation process: Develop and maintain a management review process and process improvement process for longterm corrective action: Analyze the data: Compile event data

2. 3.

4.

Prepared by:

Authority:

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.

TITLE: Nonconforming Laboratory Events Document Number: OP-8.2.1 Section: Occurrence Management

Revision Date: Status: Draft Page: 2 of 17

Step 5.

6. 7.

Action 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). Report the data: Report the data to the appropriate groups/personnel as indicated in the process for each audit. 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 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. 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. 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.

All laboratory staff

Team Leaders and Quality Officers

Directorate Directors

Prepared by:

Authority:

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.

TITLE: Nonconforming Laboratory Events Document Number: OP-8.2.1 Section: Occurrence Management

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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 Consider the medical significance of non conforming laboratory events Notify the requesting clinician/patient care area where indicated. Document each episode of non-conformance. 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. If incorrect reports have been released: The clinician/patient care area must be notified and the reports are corrected. Results of nonconforming examinations already released are amended and error corrected 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 Prepared by: Who is Responsible Technical Specialists Lab Management (Director, Team Leader Staff Technical Specialists Service Chiefs Lab Management Staff Supporting Documents

Technical Specialist Lab Management (Director, Team Leader)

Technical Specialist Laboratory Management ( Director, Team Leader).

Authority:

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.

TITLE: Nonconforming Laboratory Events Document Number: OP-8.2.1 Section: Occurrence Management What happens 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 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. 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.

Revision Date: Status: Draft Page: 4 of 17 Who is Responsible Supporting Documents

Technical Specialists Lab Management (Director, Team Leader) Technical Specialists Lab Management (Director, Team Leader) Staff

Corrective Actions

Corrected and Preventive Action Lab Nonconformin g Event Procedure

Appropriate staff

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 safetyrelated information and in which they recognize unacceptable performance.

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TITLE: Nonconforming Laboratory Events Document Number: OP-8.2.1 Section: Occurrence Management

Revision Date: Status: Draft Page: 5 of 17

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.

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TITLE: Nonconforming Laboratory Events Document Number: OP-8.2.1 Section: Occurrence Management

Revision Date: Status: Draft Page: 6 of 17

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 GuidelineSecond 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 NCE QC TAT Patient safety report Laboratory nonconforming event report Quality control Turn-around time

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TITLE: Nonconforming Laboratory Events Document Number: OP-8.2.1 Section: Occurrence Management

Revision Date: Status: Draft Page: 7 of 17

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.

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Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
NONCONFORMING EVENT Pre-analytical Unacceptable requisition Incorrect test orders Specimen collection delay Specimen recollection required PSR PSR PSR PSR NCE NCE NCE NCE NCE NCE N/A NCE NCE NCE N/A NCE INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 8 of 17

REFERRED PATIENT SAMPLE CRITICAL NON-CRITICAL CANCELLATION CODE EXPLANATION Events occurring during pre-analytical phase (specimen collection/transport/processing) Incomplete/illegible information on requisition Outcome: Delay or inability to perform testing Test not ordered by provider Wrong test ordered by provider Outcome: Delay or inability to perform testing Delay in sample collection Outcome: Delay in analysis Incorrect/expired container Specimen integrity / volume problem Sample leaking/broken

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 9 of 17

REFERRED PATIENT SAMPLE NONCRITICAL CRITICAL

NONCONFORMING EVENT Pre-analytical

CANCELLATION CODE

EXPLANATION Events occurring during pre-analytical phase (specimen collection/transport/processing) 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 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 Sample loss, breakage, delay No sample for test ordered Compromised transport (e.g. temperature requirements not acceptable) Sample loss, breakage, delay No sample for test ordered Compromised transport (e.g. temperature requirements)

Specimen labeling (not reported)

PSR

NCE

NCE

NCE

Specimen labeling (results reported)

PSR

PSR

PSR

PSR

Specimen transport (CDHA initiated) Specimen transport (NOT CDHA initiated)

PSR

NCE

PSR

NCE

PSR

NCE

NCE

NCE

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
NONCONFORMING EVENT Pre-analytical Specimen accession/handling PSR NCE PSR NCE INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 10 of 17

REFERRED PATIENT SAMPLE CRITICAL NON-CRITICAL CANCELLATION CODE

EXPLANATION Events occurring during pre-analytical phase (specimen collection/transport/processing) Sample loss, breakage, delay in laboratory Specimen leaking Insufficient formalin Clotted sample Hemolysed sample Possible contamination Incomplete filling of blood tubes Specimen too old Insufficient sample for analysis Name only Name and date of birth Unique identifier only Miscellaneous factors that results in delay testing/result reporting

Specimen integrity

PSR

NCE

NCE

NCE

Specimen volume One identifier/Absence of unique identifier Delay in testing/reporting

PSR PSR PSR

NCE NCE PSR

NCE NCE NCE

NCE NCE NCE

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
NONCONFORMING EVENT Analytical Testing not performed correctly Test results not affected Testing not performed correctly Test results affected but NOT reported) Testing not performed correctly Test results affected AND reported) Failure to follow procedure Test results affected but NOT reported Failure to follow procedure Test results affected AND reported Testing delayed / TAT not met INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 11 of 17

REFERRED PATIENT SAMPLE CRITICAL NON-CRITICAL CANCELLATION CODE EXPLANATION Events occurring during analytical phase (testing/analysis/examination) Incorrect reagent Expired reagent SOP not followed Outcome: Delay or potential delay in reporting critical results Incorrect reagent Expired reagent Failure to follow procedure Outcome: Delay or potential delay in reporting critical results Incorrect reagent Expired reagent Failure to follow procedure Outcome: Real/potential client/patient harm Technical procedure not followed. Outcome: Delay or potential delay in reporting critical results Technical procedure not followed. Outcome: Real/potential client/patient harm Laboratory established turn-around time not met Outcome: Delay or potential delay in reporting critical results

PSR

NCE

PSR

NCE

PSR

NCE

PSR

NCE

PSR

PSR

PSR

PSR

PSR

NCE

PSR

NCE

PSR

PSR

PSR

PSR

PSR

PSR

PSR

PSR

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
NONCONFORMING EVENT Analytical QC not performed correctly Test results unaffected QC not performed correctly Test results affected but NOT reported QC not performed correctly Test results affected AND reported Test results released before testing completed PSR NCE PSR NCE INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 12 of 17

REFERRED PATIENT SAMPLE CRITICAL NON-CRITICAL CANCELLATION CODE EXPLANATION Events occurring during analytical phase (testing/analysis/examination) Outcome: Delay or potential delay in reporting critical results Outcome: Delay or potential delay in reporting critical results Test result may or may not have been affected Outcome: Real/potential client/patient harm Regardless of whether patient/client is affected Outcome: Real/potential client/patient harm

PSR

NCE

PSR

NCE

PSR PSR

PSR PSR

PSR PSR

PSR PSR

NONCONFORMING EVENT

INPATIENT/AMBULATORY PATIENT SAMPLE

REFERRED PATIENT SAMPLE

CANCELLATION CODE

EXPLANATION

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
CRITICAL Analytical NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 13 of 17

CRITICAL NON-CRITICAL Events occurring during analytical phase (testing/analysis/examination) 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 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 Product expired Change in lot number unrecognized Recalled product lot number Reagent prepared improperly Reagent stored improperly Outcome: Real or potential patient harm Outcome: Delay or potential delay in reporting critical results Outcome: Delay or potential delay in reporting critical results Outcome: Real or potential patient harm

Reagent problem Test results unaffected

PSR

NCE

PSR

NCE

Reagent problem (Test results affected but NOT reported)

PSR

NCE

PSR

NCE

Reagent problem Test results affected AND reported Calibration errors Test results unaffected Calibration errors Test results affected but NOT reported Calibration errors Test results affected AND reported

PSR

PSR

PSR

PSR

PSR PSR PSR

NCE NCE PSR

PSR PSR PSR

NCE NCE PSR

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
NONCONFORMING EVENT Analytical INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 14 of 17

REFERRED PATIENT SAMPLE CRITICAL NON-CRITICAL CANCELLATION CODE EXPLANATION Events occurring during analytical phase (testing/analysis/examination) Fluctuating power supply Deterioration of photometric light source Bubbles in reagent lines Unstable ambient temperature Outcome: Delay or potential delay in reporting critical results 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 Fluctuating power supply Deterioration of photometric light source Bubbles in reagent lines Unstable ambient temperature Outcome: Real or potential client/patient harm Events that result only in delay of analysis or reporting

Equipment problem Test results unaffected

PSR

NCE

PSR

NCE

Equipment problem Test result affected but NOT reported)

PSR

NCE

PSR

NCE

Equipment problem Test result affected AND reported Testing/reporting delays

PSR PSR

PSR NCE

PSR PSR

PSR NCE

NONCONFORMING

INPATIENT/AMBULATORY PATIENT SAMPLE

REFERRED PATIENT SAMPLE

CANCELLATION CODE

EXPLANATION

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
EVENT Post-analytical Interpretation of results Results not affected Interpretation of results Results affected but NOT reported Interpretation of results Test results affected AND reported CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 15 of 17

CRITICAL NON-CRITICAL Events occurring during postanalytical phase (result reporting/communication) Results misinterpreted Calculation error Outcome: Delay or potential delay in result reporting of critical results Results misinterpreted Calculation error Outcome: Delay or potential delay in reporting of critical results Results misinterpreted Calculation error Outcome: Real or potential patient/client harm Results misinterpreted report reviewed by Service Chief of AP and appropriate pathologists Outcome: Real or potential patient/client harm Errors during entry of test result Outcome: Delay or potential delay in reporting of critical results Errors during entry of test result Outcome: Delay or potential delay in reporting of critical results Errors during entry of test result Outcome: Real or potential patient/client harm

PSR

NCE

PSR

NCE

PSR

NCE

PSR

NCE

PSR

PSR

PSR

PSR

Interpretation of results Amended pathology reports Data entry/Clerical error Test results not affected Data entry/Clerical error Test results affected but NOT reported Data entry/Clerical error Results affected AND reported

PSR

PSR

PSR

PSR

PSR PSR PSR

NCE NCE PSR

PSR PSR PSR

NCE NCE PSR

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.

Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL

Revision Date: March 14, 2008 Status: Draft Page: 16 of 17

REFERRED PATIENT SAMPLE CRITICAL NON-CRITICAL

NONCONFORMING EVENT Post-analytical Delay in transmission/communication of test results Error in transmission/communication of test results Failure to report critical/alert value Delay in reporting

CANCELLATION CODE

EXPLANATION Events occurring during post-analytical phase (result reporting/communication) Delay in results Outcome: Real or potential patient/client harm Wrong provider Error in communication between information system and electronic medical number Results not communicated Outcome: Real or potential patient/client harm Miscellaneous factors that results in delay testing/result reporting

PSR PSR PSR PSR

PSR/NCE PSR PSR PSR

PSR PSR PSR PSR

PSR/NCE PSR PSR PSR

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Authority: Dr. J. G. Heathcote

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Department of Pathology and Laboratory Medicine Capital District Health Authority Halifax, Nova Scotia
TITLE: Laboratory Nonconforming Events Document Number: OPSection: Quality Management
INPATIENT/AMBULATORY PATIENT SAMPLE CRITICAL NON-CRITICAL NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE

Revision Date: March 14, 2008 Status: Draft Page: 17 of 17

REFERRED PATIENT SAMPLE CRITICAL NON-CRITICAL NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE NCE

NONCONFORMING EVENT Other miscellaneous Purchasing / stores Receiving / delivery Vendor problem Waste management Environment / housekeeping Inventory LIS system problems

CANCELLATION CODE

EXPLANATION Events that do not fit analytical phases

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.

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Authority: Dr. J. G. Heathcote

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