# Presentation: 243827

## Assuring Quality in Laboratory Performance

- Introduction
- Laboratory Quality Systems

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

## Emphasis for CDC Global AIDS Program

- Surveillance
- Prevention activities – VCT, MTCT
- Care and treatment
- Blood safety
- Opportunistic infections – STI, TB

**Notes:**
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.

## 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

**Notes:**

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

## 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

## Systems Approach

- Ensure quality of overall process
- Detect and reduce errors
- Improve consistency within and between laboratories
- Contain costs

**Notes:**
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.

## 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

## 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

## Steps in Development of Quality Systems Initiative

- Train the trainer
- Continued technical support for all elements
- Long-term process

## Framework

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

## Organization of Training Materials

- Modular
- Designed for use by local staff
- Includes facilitator’s guide, content outline, PowerPoint presentation, exercises, supplementary materials, references

## 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

## Quality....

- Quality Assurance
- Quality Control
- Quality Improvement
- Quality Indicators
- Quality System
- Quality Management

**Notes:**
Use ISO definitions

## 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

## 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

## 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

## ISO 9000 Family

- International Organization for Standardization
- Guidance for quality in manufacturing and service industries
- Has broad applicability, many kinds of organizations can use

## 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)

## Other Sources for Standards

- NCCLS – National Committee for Clinical Laboratory Standards
- National standards
- Organizational standards
- CLIA – Clinical Laboratory Improvement Amendments

## 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)

## Quality System

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

## 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)

## 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)

-  **QUALITY CONTROL**

**QUALITY ASSURANCE**

**QUALITY SYSTEM**

-      **QUALITY   **
** ****M****ANAGEMENT**

**Stages of Quality - Hierarchy**

## Quality System

**Quality System**

**Quality Assurance**

**Quality Control**

## 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

## 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

## Comparison:  NCCLS Quality System Model to ISO 9001

## Quality System Essentials

- Organization
- Management responsibility
- Personnel
- Training and competency assessment
- Equipment
- installation and maintenance, calibration
- Purchasing and inventory

**Notes:**
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, retrieval

## Quality System Essentials

- Process control
- validation, quality control, proficiency testing, specimen management
- Information management
- Documents and records
- Occurrence Management
- document and take corrective action

**Notes:**
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. 

## 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