# Presentation: 038769

## Assuring Quality in Laboratory Performance

**Introduction and Overview **
**Laboratory Quality Systems**

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

## Accuracy and Reliability

**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

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

**The importance of quality systems**

## 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**

## Organization of Training Materials

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

## Framework

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

## 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)**

## 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**

## 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**

## Comparison:  NCCLS Quality System Model to ISO 9001

## 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**
**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**

## 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**

## Personnel:Competency Assessment

**Assess employee competence on each procedure the technician performs**
**initially **
**periodically thereafter**
**Identify retraining needs**
**Record all activities  **

**Notes:**
The purpose of competency assessment is to determine if employees have maintained and continue to demonstrate the techniques and skills for which they were trained

Procedures include total testing process: pre-, post- and analytic phases

## 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**

## 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**