# Presentation: 446087

## Overview of Quality Assurance

## Quality....

**Quality Assurance**
**Quality Control**
**Quality Improvement**
**Quality Indicators**
**Quality System**
**Quality Management**

**Notes:**
Use ISO definitions

## Why Is Quality Assurance of Testing Important ?

**Ensuring quality is the foundation of everything we do **
**Sets the standard for level of quality**
**Everyone expects high quality**
**Provides means to prevent, detect and correct problems **
**Becomes the core of a monitoring,  evaluation, & improvement system**
**Cost effective**

***Even the simplest of testing is not foolproof***

## 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

## Why do errors occur? 

**Some causes include:**
**No written procedures**
**Written procedures not followed **
**Training is not done or not completed**
**Checks not done for transcription errors**
**Individual responsibilities unclear**
**Errors can occur throughout the testing process**

**Notes:**
Once root cause is identified, steps can be taken to take corrective action.
What about QC not performed, no EQA, failure to maintain/calibrate equipment, old/deteriorated reagents, temperature problems (room temp too high), improper storage of reagents.  Do we want to include these kinds of things?

## Pre-analytic errors...examples include:

**Patient misidentification**
**Specimen mislabeled or unlabeled**
**Incorrect or compromised specimen**
**Inappropriate specimen transport conditions**
**Specimen processed incorrectly**
**Specimen stored inappropriately before testing**
**Wrong test(s) ordered**

## Analytic errors...examples include:

**Test system not calibrated**
**Results reported when control results out of range **
**Improper measurements of specimen and/or reagents**
**Reagents prepared incorrectly**
**Reagents stored inappropriately or used after expiration date**
**Instrument maintenance not done**
**Dilution and pipetting errors**

## Post-analytic errors...examples include:

**Transcription error in reporting**
**Report sent to the wrong location**
**Report illegible**
**Information system not maintained**

## Basic Elements of QA

**Organization**
**Personnel**
**Facilities, equipment, reagents and supplies**
**Policies and Procedures**
**Process control**
**Documents and records**
**Audits / Process improvement**

**Notes:**
Also referred to as Quality System Essentials in NCCLS GP26A

## Basic Elements of QA - Organization

**Planning and organizing a QA program**
**Defining scope of authority and responsibility of QA coordinator and other staff in the organization**
**Allocating resources to maintain quality requirements**
**Developing, Distributing, Implementing a Quality Manual**

**Notes:**
There will be great interest in Botswana re how to develop a quality manual.

## Basic Elements of QA - PERSONNEL

**Developing job descriptions (duties and responsibilities)**
**Providing training and continuing education programs**
**Assessing employee competence **

## PERSONNEL Competency Assessment

**Assess employee competence on each procedure the tech performs**
**Initially **
**Periodically thereafter**
**Identify retraining needs**
**Document 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

## Basic Elements of QA – Facilities, Equipment, Reagents and Supplies

**Ensure an adequate and safe work environment**
**Validate performance of equipment, reagent and supplies**
**Perform equipment maintenance, troubleshooting, service and repair**
**Establish a system to receive, inspect, accept, store and inventory incoming materials**
**Ensure safe working environment**

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

## Basic Elements of QA – Policies and Procedures 

**Method Evaluation**
**Specimen and Test Management**
**Quality Control**
**External Quality Assessment (EQA)**

## Policies and Procedures –Specimen and Test Management

**Request forms**
**Specimen **
**collection (including patient preparation, as necessary)**
**receipt and accessioning**
**rejection criteria**
**processing**
**transport**
**storage**
**Positive specimen identification throughout the testing process**

## Policies and Procedures  - Quality Control

**Written description of QC program**
**Should include all phases of testing process**
**Calibration requirements**
**Selecting or developing in-house control materials and determining frequency of use**
**Evaluating daily control results and monitoring over time**
**Using acceptance criteria**
**Troubleshooting and taking corrective action**
**Documentation**

## Slide 17

## Policies and Procedures  - External Quality Assessment (EQA)

**Selecting and enrolling in appropriate Proficiency Testing (PT) programs**
**Zimbabwe National Quality Assurance Program (ZINQAP)**
**Other national, international, or regional programs**
**Blind Rechecking**
**On-site evaluation and review**
**Evaluating performance**
**Taking corrective action**
**Documentation**

## Basic Elements of QA –Process Control

**Ensuring written policies and procedures are available in all work areas **
**Introducing new methods**
**Managing specimens and documentation of testing **
**Developing and implementing a quality control program**
**Using statistical tools**
**Participating in external quality assessment programs**
**Reporting results**

## Quality System Documentation –Quality Manual

**Policies**

**Processes**

**Procedures**

- Quality System Documentation –Quality Manual

**“****what to do”**

- “**how** **it happens”**

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

**Notes:**
Use of templates
Writing and approval process

Written policies should available for overall intentions and directions defined by the organization 
Standard Operating Procedures (SOPs) should be written for all critical steps in the laboratory’s processes

## Basic Elements of QA -Documents and Records Why Record?

**Minimized chances of error through clarity of instructions – Technical Procedures**
**Sharing of information**
**Revisit information; reference**
**Quality Assurance monitoring -  continuous action/service**
**Remember ! – Records should serve a purpose**
**Diagnostic, Research, Surveillance**
**Management tool**
**Policy and planning**

**Notes:**
A number of reasons exists for recording laboratory information:
Sharing of information  - checks and balances (supervisory review)
Periodic reports (monthly, annual) will allow the bigger picture to be seen.

Management tool: 
Forecast community and program testing needs
Budgeting
Determine Personnel needs
Determine Technology and training needs
Justify requests for resources
Productivity and performance evaluation

 Policy making
Assess health care resource utilization
Predict health care personnel and facility needs
Predict funding needs

## Quality System Documentation –Sample QA Records

**Standard operating procedures**
**Specimen log book**
**Laboratory workbooks/sheets**
**Instrument printouts – Maintenance records**
**QC / EQA records**
**Personnel **
**Patient test reports**
**Quality improvement records**

**Notes:**
Workbooks should include:  specimen identification, person performing tests 
Training or personnel
	Training checklists, competency assessment documentation ,Continuing education or in-service training)
Quality Improvement Records:
	Monitoring reports

Focus on accuracy and detail
Focus on clarity and legibility
Check ! Recheck!
Always focus on testing objective
Patient Management
Public Health Management

## Basic Elements of QA -Documents and Records

**Developing uniform format for each document type, including standardized format for forms **
**Developing and implementing a system for document revision, approval and distribution**
**Managing patient test records **
**Maintaining a document storage, retrieval and destruction system **

## Basic Elements of QA –AUDITS AND PROCESS IMPROVEMENT

**Monitoring quality indicators and results of QA activities**
**Developing criteria for and performing internal audits**
**Developing and documenting corrective action**
**Identifying opportunities for and achieving improvements**
**Investigating and managing complaints and occurrences that could adversely affect patients, employees, or visitors**

## Who is responsible for Quality?

**EVERYONE IN THE LABORATORY!**
**Laboratory management must commit to meeting quality needs.**
**Laboratory personnel must follow QA procedures.**

## QA ResponsibilitiesWho, in your organization, has responsibility for...

**Communicating commitment to and/or advocating for quality**
**Planning, implementing, and evaluating the QA Program**
**Providing QA resources such as **
**Funding, staffing, QC materials, PT/EQA**
**Identifying and assigning responsibilities**
**Training employees in QA/QC operations**
**Performing and documenting competency assessments**
**Conducting audits - compliance to the QA program Identifying and implementing improvements**

## Gap Analysis

**Determine the gaps in your QA program**
**Prioritize filling these gaps by –**
**Consider doing the quick fixes first**
**Determine what would have the greatest  positive impact**
**Develop a plan for addressing your QA needs**
**Organize a QA committee**

## Sources of Laboratory QA Guidance and Information

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