# Presentation: 360172

## How do we achieve excellent performance in the laboratory?

- The importance of
- quality systems

## Quality System Definition

- Organizational structure, resources, processes and procedures needed to implement quality management (ISO, NCCLS)

## 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)

## 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)

## Quality System

**Quality System**

**Quality Assurance**

**Quality Control**

## Quality System Essentials

- Organization
- Personnel
- Equipment
- Purchasing and inventory
- Process control (validation, quality control, proficiency testing, specimen management)

## Quality System Essentials

- Information management
- Documents and records
- Occurrence management
- Internal assessment
- Process improvement
- Service and satisfaction
- Facilities and safety

## The Quality Assurance Cycle

**The Quality Assurance Cycle**

- Pre-Analytic

- Analytic

- Post-Analytic

**Data and Lab Management**
**Safety**
**Customer Service**

- Patient/Client Prep
- Sample Collection

- Sample Receipt and Accessioning

- Sample Transport

- Quality Control

- Record Keeping

- Reporting

- Personnel Competency
- Test Evaluations

- Testing

## Organization

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

## 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

## Personnel

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

## 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

**Notes:**
When we talk about equipment, include the Laboratory Information System or should the LIS be a separate item?  Do GAP labs have LISs?

## 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

## Slide 14

## Process ControlWhat is it?

- Concerns all _*operations*_* *of the laboratory
- Examples:
- Method evaluation, validation procedures, SOPs
- Specimen management
- Quality control
- External quality assessment

## 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

## Process Control:Specimen Management

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

## Process Control:Method Evaluation

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

## 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

## 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

## 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

## 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

## 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

- 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

## Occurrence Management:How?

- Collect information about systematic problems
- Establish a process to detect all problems
- Analyze the problem, take corrective action
- Keep records

## Internal Assessment

- Self- evaluation
- ISO standards provide specific process for Internal Audit

## 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”

## 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

## 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

## Process Improvement

- Use available information to select topic for study:
- customers, complaints
- occurrence management – identified errors
- internal audits – problems found
- external assessments

## Process Improvement

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

## 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

## 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

**Notes:**
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.  

## 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

## 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