PRMLS - Finals 6 Flashcards
2 STANDARD ORGANIZATIONS FOR QUALITY ASSURANCE
ISO - CLSI
ISO MEANS
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
CLSI
CLINICAL AND LABORATORY STANDARDS INSTITUTE
WHICH STANDARD ORGANIZATION IS USED BY MANY FIELDS
ISO
WHICH STANDARD ORG IS USED BY MEDICAL FIELD
CLSI
OLD NAME FOR CLSI
NCCLS
REFERS TO THE SATISFACTION OF NEEDS AND EXPECTATION
QUALITY
EXPECTATION OF THE (2)
USERS OF THE LAB
COSTUMERS OF THE LAB
QUALITY IS ____
ZERO DEFECT
8 ELEMENTS OF TOTAL QUALITY
ETHICS
INTEGRITY
TRUST
TRAINING
TEAMWORK
LEADERSHIP
RECOGINITION
COMMUNICATION
QUALITY CONTROL DEFINITION IS BASED ON
ISO 9000: 2000
PART OF QUALITY MANAGEMENT FOCUSED ON FULFILLING QUALITY REQUIREMENTS
QUALITY CONTROL
OVERALL PROCESS OF ENSURING QUALITY CARE
QUALITY ASSURANCE
ENUMERATE DEFINITION OF QUALITY THRU TIME (3)
1950-1950 = QUALITY CONTROL -SEPERATING GOOD FROM BAD
1960-1980 = QUALITY ASSURANCE - INSPECTION SHIFTED TO PRODUCTION PROCESS
1980-2000 = QUALITY MANAGEMENT - QUALITY IS DEFINED, PLANNED
LIABILITIES (3)
ADMINISTRATIVE
CRIMINAL
CIVIL
SOURCE OF LIABILITIES (4)
ETHICS OF MT IN PH
CIVIL CODE OF THE PH
REVISED PENAL CODE
SPECIAL LAWS
FATHER OF STATISTICAL QC / BASIS FOR WESTGARD RULE
WALTER SHEWHART
“QUALITY IS FREE. POOR QUALITY IS EXPENSIVE”
PHILIP CROSBY
WHAT DID PHILIP CROSBY SAID
QUALITY IS FREE. POOR QUALITY IS EXPENSIVE
INTRODUCED USE OF STATISTICAL TOOL
EDWARDS DEMING
PARETO PRINCIPLE / QUALITY IS A CONTINOUS PROCESS
JOSEPH JURAN
THE 80/20 RULE AKA?
PARETO PRINCIPLE
SET OF ACTIVITIES THAT AIMS TO MAINTAIN HIGHEST DEGREE OF EXCELLENCE
QUALITY ASSURANCE PROGRAM
WHAT DOES TQM AND CQI MEAN?
TOTAL QUALITY MANAGEMENT
CONTINOUS QUALITY IMPROVEMENT
QUALITY MANAGEMENT PROGRAM THAT INCLUDES EACH COMPONENT
TQM AND CQI
LAW OF QAP
RA 4688
AS PER RA 4688, WHAT ARE THE TYPES OF QAP
INTERNAL AND EXTERNAL QAP
DEFINE RA 4688
ALL CLINICAL LABORATORIES SHALL HAVE A FUNCTIONAL QAP
QAP FOR TECHNICAL PROCEDURES, INPUTS, PROCESSES, OUTPUTS (REAGENTS ETC)
INTERNAL QAP
QAP BASED ON WHAT AO ? (2)
AO 59 S.2001
AO 27 S.2007
THE CL SHALL PARTICIPATE IN AN EXTERNAL EQAP
EXTERNAL QAP
REQ FOR QAP TO SUCEED (3)
TOP MANAGEMENT SUPPORT
WILLINGNESS TO CHANGE
COST EFFECTIVENESS
LABORATORY TESTS ARE INFLUENCED BY (3)
LAB ENVIRONMENT
KNOWLEDGEABLE STAFF
COMPETENT STAFF
QUALITY CONTROL
COMMUNICATIONS
RECORD KEEPING
EVERYTHING THAT PRECEDES ACTUAL TEST
PRE ANALYTICAL
EVERYTHING RELATED TO ACTUAL TESTING PROCESS
ANALYTICAL
EVERYTHING THAT COMES AFTER ANALYSIS
POST ANALYTICAL
ABILITY TO DETECT SLIGHT DIFFERENCES
SENSITIVITY
ABILITY TO DETERMINE SOLELY THE COMPOUND
SPECIFICITY
INDICATES HOW CLOSE TO TRUE VALUE
ACCURACY
INDICATES HOW CLOSE TESTS TO EACH OTHER (REPRODUCIVITY)
PRECISION
SOLUTION THAT CONTAINS KNOWN AMOUNT OF ANALYTE
STANDARDS
CAN BE ACCURATELY WEIGHED TO PRODUC A SOLUTION OF KNOWN CONCENTRATION
PRIMARY STANDARD
TYPES OF STANDARD
PRIMARY AND SECONDARY
A SUBSTANCE OF LOWER PURITY
SECONDARY STANDARD
USED TO SET VALUE USING LABORATORY’S METHOD / SUBSTANCE W/ ASSIGNED VALUE
CALIBRATOR
WHO CREATES CALIBRATOR
MANUFACTURERS
ARITHMETIC AVERAGE
MEAN
MINIMUM OF __ IF CALCULATING STANDARD DEV?
20
STATISTICAL EXPRESSION OF DISPERSION OF VALUES
STANDARD DEVIATION
SIMPLIFIED COMPARISON OF SD
COEFFICIENT OF VARIATION
TESTS PRECISION AND VARIABILITY?
TESTS ACCURACY?
- COEFFICIENT OF VARIATION
- MEAN
VALUE OF OBSERVATION
PERCENTAGE
PATH OF WORKFLOW
- PERSONNEL
- EQUIPMENT
PURCHASING AND INVENTORY - PROCESS CONTROL
- INFORMATION MANAGEMENT
- DOCUMENTS
- OCCURRENCE MANAGEMENT
- LABORATORY ASESSMENT
- PROCESS IMPROVEMENT
- COSTUMER SERVICE
MOST IMPORTANT IN EQUIPMENT
CALIBRATION
