# Presentation: 038816

## Laboratory Quality SystemsAssuring Quality in Laboratory Performance

**Introduction and Overview **
**John Elliot**

- WHO Collaborating Centre

- PPTC, Wellington, NZ

## Laboratory Testing Impacts Nearly Everyone

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

- PPTC, Wellington, NZ

## How do we achieve QUALITY [excellent] performance in the laboratory?

- PPTC, Wellington, NZ

## QUALITY is ACHIEVED BY:

- Determining the customer’s precise requirements
- Ensuring that all resources, facilities and skills required to meet the customer’s requirements are available
- Planning, documenting and implementing management procedures to ensure that the customer’s requirements are met consistently
- Ensuring that staff are trained and provided with the resources to do the job right the first time

- PPTC, Wellington, NZ

## QUALITY is ACHIEVED BY: [cont]

- Ensuring that all activities are undertaken correctly
- Ensuring that when things go wrong, effective corrective action is taken to avoid repetition of errors
- Undertaking regular reviews and audits of all processes
- Total and organised commitment from management

- PPTC, Wellington, NZ

## Slide 6

- PPTC, Wellington, NZ

## QUALITY MANAGEMENT SYSTEMOverview

**QUALITY MANAGEMENT SYSTEM****Overview**

- PPTC, Wellington, NZ

## QUALITY MANAGEMENT SYSTEMPreanalytical

- PPTC, Wellington, NZ

## QUALITY MANAGEMENT SYSTEMAnalytical

- PPTC, Wellington, NZ

## QUALITY MANAGEMENT SYSTEMPostanalytical

- PPTC, Wellington, NZ

## 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
- Testing

- Record
- Keeping

- Reporting

- Personnel Competency
- Test Evaluations

- PPTC, Wellington, NZ

## Advantages of a Systems Approach

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

- PPTC, Wellington, NZ

**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.

## A Systems Approach to Quality

-    Considers all components within a 	system
-     Identifies the connection and relationship 	(e.g., cause and effect) among the 	components

- Example: the human body system
- A headache may be caused by disorder of other components in the system

- PPTC, Wellington, NZ

## AAPI Laboratory Quality Systems Initiative

- Encourage all AAPI laboratories to use quality system concept
- Provide training and materials for use locally
- Provide technical assistance and support for quality system development and implementation

- PPTC, Wellington, NZ

## 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 quality systems plan

- PPTC, Wellington, NZ

## Steps in Development of Quality Systems Initiative

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

- PPTC, Wellington, NZ

## Organization of Training Materials

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

- PPTC, Wellington, NZ

## Framework

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

- PPTC, Wellington, NZ

## ISO 9000 Family

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

- PPTC, Wellington, NZ

## 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)

- PPTC, Wellington, NZ

## NCCLS: A Quality  System Model for Health Care  (HS 1-A)

- Lays out quality system model
- Has applicability to all health care systems, including laboratory
- Describes 12 quality system essentials
- Applies quality design consistent with ISO 9000 series

- PPTC, Wellington, NZ

## NCCLS: Quality System Model for Laboratory Services (GP 26-A2)

- Laboratory application document for quality system
- Provides “how-to,” examples
- Assists lab in improving processes
- Describes path of workflow
- Relates to HS1-A

- PPTC, Wellington, NZ

## Slide 23

- PPTC, Wellington, NZ

## Comparison:  NCCLS Quality System Model to ISO 9001

- <date/time>

**Comparison:  NCCLS Quality System Model to ISO 9001**

## Quality System Definition

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

- In other words... all activities which contribute to quality
-  of testing, directly or indirectly.** **

- PPTC, Wellington, NZ

## QUALITY ASSURANCEDEFINITION

**All planned and systematic actions necessary to provide adequate confidence that goods or services will satisfy the customer’s needs.**

- PPTC, Wellington, NZ

## QUALITY ASSURANCEanother definition

*The right result, **	*at the
*Right time,* 		on the
*Right specimen,**	*from the
*Right patient,* 	with result interpretation 				based on
*Correct reference data, *and at the
*Right price*

- PPTC, Wellington, NZ

## EXTERNAL QUALITY ASSESSMENT (EQA)

- EQA REFERS TO A SYSTEM IN WHICH THE PERFORMANCE OF A LABORATORY IS ASSESSED
_***PERIODICALLY***_***   *****AND   **_***RETROSPECITIVELY***_
- BY AN INDEPENDENT OUTSIDE AGENCY TO INDICATE TO THE LABORATORY STAFF WHERE THERE MAY BE SHORTCOMINGS AND HENCE INDICATES A NEED FOR IMPROVING AND/OR CHANGING IQC PROCEDURES.

- PPTC, Wellington, NZ

## 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)

- PPTC, Wellington, NZ

## INTERNAL QUALITY CONTROL (IQC)

**IQC REFERS TO THE SET OF PROCEDURES UNDERTAKEN BY THE LABORATORY STAFF FOR THE**
_***CONTINUOUS ***_**AND **_***IMMEDIATE***_** **
**MONITORING OF LABORATORY WORK IN ORDER TO DECIDE WHETHER THE RESULTS ARE RELIABLE ENOUGH TO BE RELEASED.**

- PPTC, Wellington, NZ

## Quality System

**Quality System**

**Quality Assurance**

**Quality Control**

- PPTC, Wellington, NZ

## IMPLEMENTATION of the QUALITY SYSTEM

- Planning what is to be done
- Documenting the plan
- Implementing the plan
- Periodically auditing procedures to ensure the plan is still working and being used
- Reviewing the plan periodically to confirm its continuing effectiveness

- PPTC, Wellington, NZ

## QUALITY SYSTEM MANUAL

**Policies**

**Processes**

**Procedures**

**QUALITY SYSTEM MANUAL**

**“****what to do”**

- “**how** **it happens”**

- “**how** **to do it”** -  (**SOPs**)

- PPTC, Wellington, NZ

## IF IT IS NOT WRITTEN DOWN IT DID NOT HAPPEN!!!

- PPTC, Wellington, NZ

## Quality System Essentials

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

- PPTC, Wellington, NZ

**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/verification, quality control, proficiency testing, specimen management
- Information management
- Documents and records
- Occurrence Management
- Document and take corrective action

- PPTC, Wellington, NZ

**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

- PPTC, Wellington, NZ

## Organization

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

**A culture **
**committed **
**to quality**

**Quality policy **
**& standards**

**Clearly defined**
**responsibility**
** ****& accountability**

**Sufficient**
**resources**

- PPTC, Wellington, NZ

## Personnel

**Retention**

**Human resource**
**planning**

**Hiring**

**Performance**
**management**

**Training**

**Supervision**

- PPTC, Wellington, NZ

## Equipment Management

**Maintenance,**
**service & repair**

**Selection**

**Acquisition**

**Installation &**
**initial calibration**

**Troubleshooting**

**Disposition**

- PPTC, Wellington, NZ

## Purchasing and Inventory

- <date/time>

**Purchasing and Inventory**

**Inventory**
**management**

**Procurement**

**Receiving**

**Storage**

**Record**
**keeping**

## Process Control

- <date/time>

**Process Control**

**External**
**Quality**
**Assessment**

**Standard **
**operating**
**procedures**

**Specimen**
**management**

**Quality**
**control**

## Information Management

- <date/time>

**Information Management**

**Information**
**flow**

**Data collection**
**& management**

**Computer**
**skills**

**Patient privacy &**
**confidentiality**

## Documents and Records

- <date/time>

**Documents and Records**

**Document**
**storage/retrieval**

**Standardized**
**forms**

**Document**
**destruction**

**Document**
**distribution **

**Document**
**approval**

## Occurrence Management

- <date/time>

**Occurrence Management**

**Written **
**procedures for**
**addressing errors **

**Corrective**
**actions**

**Occurrence**
**records**

**Occurrence**
**reporting**

## Assessment

- <date/time>

**Assessment**

**Internal audit **
**or self**
**evaluation**

**External **
**evaluation**

**Improvement**
**measures**

## Process Improvement

- <date/time>

**Process Improvement**

**On-going**
**data**
**collection**

**Improvement**
**measures**

## Service and Satisfaction

- <date/time>

**Service and Satisfaction**

**Monitoring **
**Customer**
**satisfaction**

**Process **
**improvement**

**Rewards**

## Facilities and Safety

- <date/time>

**Facilities and Safety**

**Testing and**
**storage**
**areas**

**Safety practice**

**Safety **
**procedures**
**& records**

## WHO IS RESPONSIBLE FOR QUALITY?

- To be responsible for Quality in **YOUR LABORATORY**

- PPTC, Wellington, NZ

## LABORATORY MANAGEMENT MUST COMMIT TO MEETING QUALITY NEEDS, ESTABLISH POLICIES, PROCESSES AND PROCEDURES

EVERY STAFF MEMBER IS RESPONSIBLE FOR THE QUALITY OF THEIR WORK.

EVERY STAFF MEMBER MUST BE AWARE OF THE QUALITY OBJECTIVES AND POLICIES OF THE LABORATORY 

**EVERY STAFF MEMBER IS RESPONSIBLE FOR THE QUALITY OF THEIR WORK.**
**EVERY STAFF MEMBER MUST BE AWARE OF THE QUALITY OBJECTIVES AND POLICIES OF THE LABORATORY **

- PPTC, Wellington, NZ

## Sources of Laboratory QS Guidance and Information

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

- PPTC, Wellington, NZ