lecture 11 Flashcards
what is QUALITY
-Providing a service that is accurate, timely and sustainable
-Refers to the satisfaction of needs and expectations of users (clinicians) and customers (patients)
-Repeat work is wasteful and adds cost
-Should be putting out the “best” result you can generate
-Should be continuously monitoring and improving upon testing, efficiency, reporting & entire processes.
Quality control - quality assurance - quality cost management - quality management system - total quality management
QUALITY CONTROL what is it
-Individual activities used to fulfill requirements for quality and regulatory compliance
-Reduces variation in results, ensures reliability of lab data/results
-Detects errors –acts as an early warning system
-Ensures Personnel competency
-Every technologist responsible for QC
internal QC of reagents media chemical
external of supplier selection , service performance
FREQUENCY OF QC
- based on manufacturer recommendation or CLSI guidelines
Equipment QC varies with each piece- Example: temperatures taken daily but biosafety airflow control is yearly
Reagent QC for every new shipment, lot#, daily or in some instances every time the test is performed
Media QC done by manufacturer but certain high performance or complex media must still be retested weekly
Susceptibility testing QC outlined in CLSI – must use ATCC strains
Personnel competency must be controlled – proficiency testing, proof of education level, peer review of results
All new testing or changes in testing must go through validation process
QC REPORTING & FAILURE
-All QC testing must be recorded either electronically or as a hard paper copy
-Must include results with date & initials.
-Must also record steps taken to rectify QC failure.
Basic Steps to take if QC fails:
1.Review steps in procedure
2.Check expiry dates & storage conditions
3.Check purity of ATCC stock
4.Repeat test
5.Inform the Senior or Quality manager – all staff
IF QC FAILS
- investigate by reviewing all steps, all expiry dates, correct supplies/reagents, incubation conditions, measurements (McFarland reading), transcription errors.
Repeat QC -Do not repeat with same ATCC cultures unless you are sure the QC problem was due to human error
Notify Senior Staff - All staff need to know if equipment, reagent or media is malfunctioning!
Do not report any patient test results or release supplies into use if QC failed or repeat testing continues to fail
Notify Physicians of delay, notify supplier if from new shipment
Call in Equipment service person to fix malfunctions
Consequences of poor QC
Repeat tests = wasted reagents more costly
Delay in reporting & in diagnosis -poor quality patient care
QUALITY ASSURANCE (QA)
-Activities to verify QC is done properly
-Looks at broader measures and monitors of laboratory performance like analytical as well as pre & post analytical processes
-Usually performed by a Senior or Quality manager
Purpose of QA:
Ensure QC are being performed and documented
Improve process performance
Evaluate corrective actions
Prevent re-occurrence
QA includes follow up for failed QC:
Ensure that corrective steps are followed and problem is solved
Return product, order new or get supplies from another source, place faulty equipment out of service.
QA Activities
-Performing external proficiency tests
-Internal audits of lab processes
-Monitor turn around time (TAT)
-Audit/review staff
QA TOOLS - flow charts, cause and effect, fishbone, histograms , scatter diagrams
LAB PROCESSES INCLUDED IN QA
Analytical activities: actual lab testing
Pre-analytical activities: before the specimen
reaches the lab
-Test ordering patient prep, specimen collection, identification and transport
- “garbage in, garbage out”. accurate timely patient results can only be obtained if the proper specimens are collected
Post-analytical activities: after testing –with results
Result transcription, delivery, review & action taken
QUALITY COST MANAGEMENT
Methods that allows an organization to determine:
-how resources are used for activities to prevent poor quality
- quality of the organization’s products or services
-Cost is not just monetary- There is also a cost to patient care & reputation of hospital
QUALITY MANAGEMENT SYSTEM
-Formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives
-Involves continued improvement of all processes
- Quality Manual & Departmental operating manuals
12 quality system essentials to address
Organization
Personnel
Equipment
Purchasing & Inventory
Process Control
(Pre & Post Analytical)
Documentation & Records
Occurrence Management
Assessments
Process Improvement
Facilities & Safety
LIS
Customer Service
TOTAL QUALITY MANAGEMENT
-The big picture
- organization’s goals, objectives and quality requirements
-Integrate all aspects of health care
-All employees and departments are included –quality is everyone’s business
