How do we achieve excellent performance in the laboratory

1. How do we achieve excellent performance in the laboratory? The importance of quality systems

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

3. Quality Assurance Definitions 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)

4. Quality Control Definitions 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)

6. Quality System Essentials Organization Personnel Equipment Purchasing and inventory Process control (validation, quality control, proficiency testing, specimen management)

7. Quality System Essentials Information management Documents and records Occurrence management Internal assessment Process improvement Service and satisfaction Facilities and safety

9. Organization Support from the top level of the organization Involve all persons in the organization Conform with any regulatory requirements

10. Organization Plan and organize the quality program Define scope of authority and responsibility of quality coordinator and other staff in the organization Allocate sufficient resources to maintain quality requirements Develop, distribute, implement a Quality Manual

11. Personnel Develop job descriptions (duties and responsibilities) Provide orientation, training, and continuing education programs Assess employee competence and performance

12. Equipment Select equipment and assure appropriate use Provide for installation and initial calibration Set up mechanisms for maintenance, service, and repair, including timetables Require routine calibration Provide information for troubleshooting Regularly review all documentation When we talk about equipment, include the Laboratory Information System or should the LIS be a separate item? Do GAP labs have LISs?When we talk about equipment, include the Laboratory Information System or should the LIS be a separate item? Do GAP labs have LISs?

13. Purchasing and Inventory Define criteria for products and services to be purchased Establish a system to receive, inspect, accept, store and inventory incoming materials Assess and maintain inventory Establish a system to connect materials to appropriate patients, activities, or records

15. Process ControlWhat is it? Concerns all operations of the laboratory Examples: Method evaluation, validation procedures, SOPs Specimen management Quality control External quality assessment

16. Basic Elements of Process Control Providing written policies and procedures Managing specimens Implementing a quality control program Participating in external quality assessment programs Reporting results Introducing new methods Using statistical tools

17. Process Control:Specimen Management Request forms Specimen - identification throughout process collection (including patient preparation) receipt and accessioning rejection criteria processing transport storage

18. Process Control:Method Evaluation Role of central purchasing body Assure that method works in your setting Perform parallel testing, monitor new tests over time

19. Process Control:Standard Operating Procedures Update standard operating procedures regularly Have current SOPs available at the worksite Ensure that all laboratory staff follow SOPs exactly

20. Process Control: Quality Control Provide written description of QC program Select materials, determine frequency of use Evaluate control results daily and over time Establish and use acceptance criteria Take corrective action, provide for troubleshooting Document, document, document

21. Process Control:External Quality Assessment (EQA) Select appropriate proficiency testing programs Perform blind rechecking or sample splitting Conduct on-site evaluation and review Evaluate overall performance Take corrective action Document

22. Information Management Managing incoming and outgoing information Standardization of information capture Privacy and confidentiality of patient information Competency in relevant computer skills Word processing Spreadsheet Database

23. 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

24. Occurrence Management The process of dealing with laboratory problems and errors as they occur Perform in a timely manner Provide information to those affected by the problem or error

25. Occurrence Management:How? Collect information about systematic problems Establish a process to detect all problems Analyze the problem, take corrective action Keep records

26. Internal Assessment Self- evaluation ISO standards provide specific process for Internal Audit

27. Internal Assessment:How? Conduct periodic assessment of the quality system and laboratory operations Compare to internal and external benchmarks Are requirements being met? � �gap analysis�

28. Gap Analysis Identify gaps, areas of weakness in laboratory Prioritize by � Considering the quick fixes first Determining what would have the greatest positive impact Develop a plan for addressing needs

29. Process Improvement A systematic and periodic approach to improving laboratory quality Design a study so that results can be statistically measured, if possible Set a timeline, one study each 6 months or year

30. Process Improvement Use available information to select topic for study: customers, complaints occurrence management � identified errors internal audits � problems found external assessments

31. Process Improvement Use a problem-solving process: identification, analysis, root cause of problem, ideas for solutions, implementation, monitoring

32. Service and Satisfaction Actively seek information on both internal and external satisfaction Customer surveys Focus groups Use information in process improvement Value and reward staff providing good service

33. Facilities and Safety Assure that facilities, testing and storage areas, are adequate in order to produce reliable testing Ensure an adequate and safe work environment Meet all regulatory environmental requirements This is a major topic, and one would need several days in order to fully explore all aspects. We will not attempt to do so in this workshop, but want to point out the great importance of adequate facilities, as well as safety for both laboratory staff, and others who may come in contact with materials, air, etc. from the laboratory. This is a major topic, and one would need several days in order to fully explore all aspects. We will not attempt to do so in this workshop, but want to point out the great importance of adequate facilities, as well as safety for both laboratory staff, and others who may come in contact with materials, air, etc. from the laboratory.

34. Who is responsible for Quality? EVERYONE IN THE LABORATORY! Laboratory management must commit to meeting quality needs Laboratory personnel must follow all quality assurance procedures

35. Sources of Laboratory QA Guidance and Information