Assuring Quality in Laboratory Performance

1. Assuring Quality in Laboratory Performance Introduction Laboratory Quality Systems

2. Accurate, reliable lab testing essential to all aspects of health care

3. Emphasis for CDC Global AIDS Program Surveillance Prevention activities � VCT, MTCT Care and treatment Blood safety Opportunistic infections � STI, TB Note that not only HIV testing is involved, very broad range of testing is needed for these activities. Care and treatment � wide range of hematology and chemistry tests. Many microbiology tests. Need many tests in support of the new President�s initiative. Although many kinds of testing, often done in the same laboratory, under the same management. An integrated approach offers many advantages, saves resources, results in improvement in all testing. Note that not only HIV testing is involved, very broad range of testing is needed for these activities. Care and treatment � wide range of hematology and chemistry tests. Many microbiology tests. Need many tests in support of the new President�s initiative. Although many kinds of testing, often done in the same laboratory, under the same management. An integrated approach offers many advantages, saves resources, results in improvement in all testing.

4. Achieving high performance of laboratories Lab assessment in GAP-supported countries indicates quality assurance deficits Many GAP-supported countries have begun efforts to improve quality assurance programs Requests for training and assistance often focus on quality assurance issues Lab assessments conducted by teams, have been done in many GAP countries Examples of kinds of problems: Poorly maintained equipment 2. Lack of quality control, EQA 3. Poor or no documentation Specimen management problems � for example, transport of specimens and surveillance Many anecdotal examples: QC out of range, just adjust the patient values 6. �we are providing erroneous data� Zimbabwe EQA system. 120 labs last year, now 105. Each survey, approximately 50% return results, but not same set for each event. Over time, approximately 20% of labs consistently participate. Many countries have little to no EQA available beyond national reference labs. Perceived need within the countries where we work � requests for help. Botswana laboratory assessment, 2001. APHL/CDC. Quality assurance needs identified QC gaps � visited labs indicate that QC material is on hand. Frequently: do not use with every run, do not keep permanent records of results, no analysis of data. Zambia � if QC reads out, adjust patient results to match. Documents and records a big problem � very often only basic register kept, no info on reagents, controls, personnel. At least one lab where used a worksheet, reported results, could not produce any permanent record of results. No recognition of need for monitoring Tanzania analysis by Nicholas Crisp � perhaps 46% ? of all lab results erroneous Many of these problems recognized at the national level � requests for help and training for putting in place a quality assurance program/quality management system to help improve process Lab assessments conducted by teams, have been done in many GAP countries Examples of kinds of problems: Poorly maintained equipment 2. Lack of quality control, EQA 3. Poor or no documentation Specimen management problems � for example, transport of specimens and surveillance Many anecdotal examples: QC out of range, just adjust the patient values 6. �we are providing erroneous data� Zimbabwe EQA system. 120 labs last year, now 105. Each survey, approximately 50% return results, but not same set for each event. Over time, approximately 20% of labs consistently participate. Many countries have little to no EQA available beyond national reference labs. Perceived need within the countries where we work � requests for help. Botswana laboratory assessment, 2001. APHL/CDC. Quality assurance needs identified QC gaps � visited labs indicate that QC material is on hand. Frequently: do not use with every run, do not keep permanent records of results, no analysis of data. Zambia � if QC reads out, adjust patient results to match. Documents and records a big problem � very often only basic register kept, no info on reagents, controls, personnel. At least one lab where used a worksheet, reported results, could not produce any permanent record of results. No recognition of need for monitoring Tanzania analysis by Nicholas Crisp � perhaps 46% ? of all lab results erroneous Many of these problems recognized at the national level � requests for help and training for putting in place a quality assurance program/quality management system to help improve process

6. Systems Approach Ensure quality of overall process Detect and reduce errors Improve consistency within and between laboratories Contain costs So, what do we achieve with a systems approach? In response to the need for improvement, decided that an initiative to develop, build on, and implement laboratory systems in GAP-supported countries is a high priority for laboratory support group. So, what do we achieve with a systems approach? In response to the need for improvement, decided that an initiative to develop, build on, and implement laboratory systems in GAP-supported countries is a high priority for laboratory support group.

7. GAP Laboratory Quality Systems Initiative Encourage all GAP countries to use quality system concept Provide assistance in development of national quality systems Provide training materials for use locally Provide long-term technical support for quality system development and implementation

8. Steps in Development of Quality Systems Initiative Develop framework for common approach Training materials � CDC/APHL workgroup Workshops Present framework Provide information on training Encourage development and implementation of national quality systems plan

9. Steps in Development of Quality Systems Initiative Train the trainer Continued technical support for all elements Long-term process

10. Framework Common definitions Importance of ISO philosophy Aim for simplicity Emphasis on performance, not process Convey importance of systems approach

11. Organization of Training Materials Modular Designed for use by local staff Includes facilitator�s guide, content outline, PowerPoint presentation, exercises, supplementary materials, references

12. Timeline First workshop, 17 African countries invited: Botswana, July 28 � August 1 Initial training modules in preparation Workshop for Asian GAP countries: 2004 On-going activities � long-term project

13. Quality�. Quality Assurance Quality Control Quality Improvement Quality Indicators Quality System Quality Management Use ISO definitionsUse ISO definitions

14. Total Quality Management First described Feigenbaum in 1957 Since 1980�s, important management theory in industry and business W. Edwards Deming,14 points for quality improvement Joseph Juran, 85/15 rule

15. TQM Philosophy Derived from earlier concepts of: Quality control � applies statistical methods to monitor specific service outcomes Quality assurance � applies a framework for establishing quality standards

16. TQM Definition Not limited to standard setting and quality control Is concerned with all aspects of organizational management, continuous effort Concentrates on processes as well as products Centered on quality, long-term success User satisfaction a priority

17. ISO 9000 Family International Organization for Standardization Guidance for quality in manufacturing and service industries Has broad applicability, many kinds of organizations can use

18. ISO Documents - Laboratory ISO 9001:1994 Quality Systems � Model for QA in design, development production, installation, and servicing ISO/FDIS 15189 � Quality management in the clinical laboratory (1998) ISO/IEC 17025 � General requirements for the competence of testing and calibration labs (1998)

19. Other Sources for Standards NCCLS � National Committee for Clinical Laboratory Standards National standards Organizational standards CLIA � Clinical Laboratory Improvement Amendments

20. Quality Management All activities of the overall management function that determine quality policy objectives, implement them by means such as quality planning, quality control, quality assurance, and quality improvement within the system (NCCLS)

21. Quality System Organizational structure, resources, processes and procedures needed to implement quality management (ISO, NCCLS)

22. Quality Assurance Planned and systematic activities to provide adequate confidence that requirements for quality will be met (ISO) Includes IQC, EQA, pre-analytic phase, test standardization, post-analytic phase, management, and organization (WHO, 1992)

23. Quality Control Operational techniques and activities used to fulfill requirements for quality (ISO) Internal quality control (IQC) � set of procedures for continuously assessing laboratory work and the emergent results; immediate effect, should actually control release of results (WHO, 1981)

27. Quality System Essentials NCCLS : Quality System Model for Health Care (HS1-A) NCCLS: Application of a Quality System Model for Laboratory Services (GP26-A2) Model uses 12 essentials, based on the 20 quality system elements in ISO 9001 Simplifies, uses language more familiar to laboratories

28. Comparison: NCCLS Quality System Model to ISO 9001

29. Quality System Essentials Organization Management responsibility Personnel Training and competency assessment Equipment installation and maintenance, calibration Purchasing and inventory Organization Policies. Support from the top levels, involve all persons, conform with any regulatory requirements Process. QA program, define scope of authority and responsibility of QA coordinator and others; allocate sufficient resources, Quality Manual. Personnel Job descriptions Orientation, training, and continuing education programs Employee competence and performance Equipment Proper selection, appropriate use Installation and initial calibration Mechanisms for maintenance, service, repair, include timetables Require routine calibration Troubleshooting Review of documentation Purchasing and Inventory Define criteria for products and services to be purchased System for receiving, inspectding, accepting, storing and inventorying incoming materials Maintain inventory System to connect materials to appropriate patients activities or records Process control This category includes much of what many people consider to be traditional quality assurance All operations or processes Method evaluation and validation Technical procedures or SOPs Specimen management: collection, preparation, storage, etc Quality control procedures External quality assessment, including proficiency testing Information management May be manual or computerized Standardization Privacy, confidentiality Accessibility, retrievalOrganization Policies. Support from the top levels, involve all persons, conform with any regulatory requirements Process. QA program, define scope of authority and responsibility of QA coordinator and others; allocate sufficient resources, Quality Manual. Personnel Job descriptions Orientation, training, and continuing education programs Employee competence and performance Equipment Proper selection, appropriate use Installation and initial calibration Mechanisms for maintenance, service, repair, include timetables Require routine calibration Troubleshooting Review of documentation Purchasing and Inventory Define criteria for products and services to be purchased System for receiving, inspectding, accepting, storing and inventorying incoming materials Maintain inventory System to connect materials to appropriate patients activities or records Process control This category includes much of what many people consider to be traditional quality assurance All operations or processes Method evaluation and validation Technical procedures or SOPs Specimen management: collection, preparation, storage, etc Quality control procedures External quality assessment, including proficiency testing Information management May be manual or computerized Standardization Privacy, confidentiality Accessibility, retrieval

30. Quality System Essentials Process control validation, quality control, proficiency testing, specimen management Information management Documents and records Occurrence Management document and take corrective action Documents and records: Develop uniform format for each document type, including standardized format for forms Develop and implement a system for document revision, approval, and distribution Manage patient test records Maintain a document storage, retrieval, and destruction system Occurrence management Collect information about systematic problems Establish a process to detect and document all problems Analyze the problem Internal assessment Conduct periodic assessment of the quality system and operations Compare to internal and external benchmarks Are requirements being met � gap analysis Process Improvement Many sources of information: customers, occurrence management, internal audits, external assessments Use a problem-solving process; identification, analysis, root cause of problem, ideas for solutions, implementation, monitoring Service and satisfaction 1. Actively seek information on both internal and external satisfaction. Documents and records: Develop uniform format for each document type, including standardized format for forms Develop and implement a system for document revision, approval, and distribution Manage patient test records Maintain a document storage, retrieval, and destruction system Occurrence management Collect information about systematic problems Establish a process to detect and document all problems Analyze the problem Internal assessment Conduct periodic assessment of the quality system and operations Compare to internal and external benchmarks Are requirements being met � gap analysis Process Improvement Many sources of information: customers, occurrence management, internal audits, external assessments Use a problem-solving process; identification, analysis, root cause of problem, ideas for solutions, implementation, monitoring Service and satisfaction 1. Actively seek information on both internal and external satisfaction.

31. Quality System Essentials Internal assessment Process improvement Revise process based on information gathered Service and satisfaction Health care providers, patients Facilities and Safety Design for proper flow and ergonomics Safety of staff, others, environment