1. Overview of Quality Assurance

2. Quality…. Quality Assurance Quality Control Quality Improvement
Quality Indicators
Quality System
Quality Management
Use ISO definitions

3. 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

4. Analytic The Quality Assurance Cycle Pre-Analytic Post-Analytic
Patient/Client Prep
Sample Collection
Personnel Competency
Test Evaluations
Reporting
Data and Lab Management
Safety
Customer Service
Post-Analytic
Sample Receipt and Accessioning
Record Keeping
Sample Transport
Quality Control
Testing
Analytic

5. 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
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?

6. 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

7. 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

8. Post-analytic errors… examples include:
Transcription error in reporting
Report sent to the wrong location
Report illegible
Information system not maintained

9. Basic Elements of QA Organization Personnel
Facilities, equipment, reagents and supplies
Policies and Procedures
Process control
Documents and records
Audits / Process improvement
Also referred to as Quality System Essentials in NCCLS GP26A

10. 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

11. Basic Elements of QA - PERSONNEL
Developing job descriptions (duties and responsibilities)
Providing training and continuing education programs
Assessing employee competence

12. PERSONNEL Competency Assessment
Assess employee competence on each procedure the tech performs
Initially
Periodically thereafter
Identify retraining needs
Document all activities
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

13. 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
When we talk about equipment, include the Laboratory Information System or should the LIS be a separate item?

14. Basic Elements of QA – Policies and Procedures
Method Evaluation
Specimen and Test Management
Quality Control
External Quality Assessment (EQA)

15. 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

16. 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

18. Policies and Procedures - External Quality Assessment (EQA)
Selecting and enrolling in appropriate Proficiency Testing (PT) programs
Blind Rechecking
On-site evaluation and review
Evaluating performance
Taking corrective action
Documentation

19. 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

20. Quality System Documentation – Quality Manual
“what to do”
Policies
“how it happens”
Processes
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
“how to do it” - (SOPs)
Procedures

21. 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
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

22. Quality System Documentation – Sample QA Records
Standard operating procedures
Specimen log book
Laboratory workbooks/sheets
Instrument printouts – Maintenance records
QC / QA records
Personnel
Patient test reports
Quality improvement records
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

23. 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

24. 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

25. Who is responsible for Quality?
EVERYONE IN THE LABORATORY!
Laboratory management must commit to meeting quality needs.
Laboratory personnel must follow QA procedures.

26. 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
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

27. 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

28. Sources of Laboratory QA Guidance and Information
World Health Organization (WHO)
International Standards Organization (ISO)
NCCLS
CDC guidelines
Professional & accrediting organizations
National standards & regulations