Overview of Quality Assurance

Quality…. Quality Assurance Quality Control Quality Improvement Quality Indicators Quality System Quality Management 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

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

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?

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 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

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

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

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

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 “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

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

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

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 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