Quality Flashcards
What is a quality management system?
A collection of processes focussed on meeting customer requirements and enhancing satisfaction.
Define EQA
External quality assurance/assessment
Ensures all labs testing the same sample will give the same results
6 “Rights”
ie, how to keep customers satisfied
Test - keep them up-to-date and improve them
Sample
Patient
Result - with accuracy, advice/interpretation
Doctor/requestor
Timeframe
Detect and respond to errors
Benefits of a QMS
- Safety (patient, public, staff, environment), error reduction
- Accreditation and funding
- Efficiency, productivity, TAT
- Reputation - perception of competency, commercial benefits
- Comparability of results
Absolute requirements of a QMS
Management system to establish and support policies and objectives that cover the following processes that make up the quality framework:
1. Personnel
2. Facilities and safety
3. Documents
4. Testing process
5. Information (results)
6. Non-conformances and improvement
7. Supplies
8. Equipment
Roles of a quality manager
No longer specifically demanded by lSO15189.
Coordinates quality management activities
Act as an interface between lab and accreditation body
Assist with interpretation of stds
Translate standards into practical aspects of lab work
May also be responsible for other compliance matters
- biological containment
- pt complaints
- health and safety
- environmental
Components of the quality framework
- Documents - policies, procedures, records - creation, retention, storage, disposal
- Personnel - induction, competency, authorisation, continuing education
- Facilities, safety - pre-analytical, testing, storage, staff facilities
- Equipment - selection, acceptance, use, maintenance, calibration, traceability
- Reagents and consumables - selection, acceptance, storage, records (lot, expiry)
- Service agreements - interactions with other entities
- Process requirements - testing, IQC, EQA
- Information - control and management
- Non-conformities and improvements
Obtaining the right result requires
- Unambiguous methods
- Reagents in date
- Operators know what they are doing and adhere to the method
- Accurate documentation of results
- Testing of known samples
- Assurance of analytical quality (IQA, EQA, clinical validation)
Ensuring the right patient requires
- 3 identifiers
- Unique lab no. for each speci
- Checking the speci details match the request form
Pre-analytical factors
Dr request
Patient prep
Speci collection
Speci transport
Speci processing
Post-analytical factors
Result validation (comments)
Report generation (RIs/clinical decision limits)
Receipt of report by Dr
Interpretation
Clinical advice based on results
Action taken
QC activities
Ongoing instrument standardisation checks
Instrument maintenance
Analysis of control material
Statistical or graphical assessment of results from control material
Internal clinical/technical audit
T or F: Participation in an EQA program is required in order to maintain accreditation for all labs in Australasia
True
Define audit
A systematic, independent process of gathering objective evidence to determine whether specified criteria are being met.
Types of audit
Spot - made after events/incidents, or simply to ensure a process has occurred that should have
Examination/witness - confirm that actual procedure matches documented procedure (used by assessors)
Vertical - follows a sample through the entire testing system
Horizontal - done by accreditation bodies; assesses quality and competency of a department against ISO15189 criteria
