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)

5
Quality System
Quality Assurance
Quality Control
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

8
The Quality Assurance Cycle
Pre-Analytic
Patient/Client Prep Sample Collection
Personnel Competency Test Evaluations
Reporting

• Data and Lab Management
• Safety
• Customer Service

Post-Analytic
Sample Receipt and Accessioning
Record Keeping
Sample Transport
Quality Control
Testing
Analytic
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

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

14
(No Transcript)
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 ControlSpecimen Management

• Request forms
• Specimen - identification throughout process
• collection (including patient preparation)
• receipt and accessioning
• rejection criteria
• processing
• transport
• storage

18
Process ControlMethod Evaluation

• Role of central purchasing body
• Assure that method works in your setting
• Perform parallel testing, monitor new tests over
  time

19
Process ControlStandard 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 ControlExternal 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 ManagementHow?

• 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 AssessmentHow?

• 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

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

• World Health Organization (WHO)
• International Organization for Standardization
  (ISO)
• NCCLS
• CDC guidelines
• Professional accrediting organizations
• National standards regulations