QUALITY IN LABORATORY Flashcards
MOTHER NOTES + GRAND FINAL COACHING
MOST WIDELY USED APPROACH to QUALITY IMPROVEMENT in the healthcare
PDCA CYCLE
another term for PDCA CYCLE
DEMING CYCLE
provides both a management philosophy or organizational development and a management process for improvement of quality in all aspects of work
TOTAL QUALITY MANAGEMENT
necessary to standardize the remedy, establish measures for performance monitoring, and ensure that the performance achieved satisfies quality requirements
QUALITY PLANNING
includes processes, policies, practices, and procedures that define how all aspects of work are done
QUALITY LABORATORY PROCESS
involves statistical control procedures as well as nonstatistical checks, e.g. linearity checks, temperature monitors, reagent and standard checks
QUALITY CONTROL
concerned with broader measures of laboratory performance including TAT, px identification, spx collection, and test utility
QUALITY ASSESSMENT
provides a structured problem-solving process to help identify the root cause of a problem and a remedy for that problem
QUALITY IMPROVEMENT
a comprehensive set of policies, procedures, and practices that are followed to ensure that a laboratory’s results are reliable
QUALITY ASSURANCE
ensures that a particular test method is working properly and that results of that test are reliable; part of QA
QUALITY CONTROL
includes record keeping, maintenance and calibration of equipment, PROFICIENCY TESTING, quality control, and training of personnel
QUALITY ASSURANCE
NEARNESS OR CLOSENESS OF THE ASSAYED VALUE to the true or target value
QUALITY ASSURANCE
3 types of studies that ESTIMATE ACCURACY
- RECOVERY
- INTERFERENCE
- SAMPLE COMPARISON
pair of medical decision points that span limits of results EXPECTED FOR A DEFINED HEALTHY POPULATION
REFERENCE INTERVAL
in verifying a reference interval, how many study individuals are required?
20
how many study individuals are needed when establishing a reference interval?
120
FRIST STEP IN METHOD EVALUATION; usually done by running two control materials twice a day over a 10-day period
PRECISION STUDY
involves spiking a sample with a known amount of an analyte and determining how much of it can be detected by the method in the presence of other compounds in the matrix
RECOVERY STUDY
ability of an analytical method to MEASURE ONLY THE ANALYTE OF INTEREST
SPECIFICITY
SPECIFIC KAY ISA LANG IYANG PANGITAON!!! (murag ako sakong crush 😂)
ability of an analytical method to MEASURE THE SMALLEST CONCENTRATION OF THE ANALYTE
SENSITIVITY
mabagting dayon kay sensitive ang ears, kiligon pag madungog si crush
ability of an analytical method to give repeated results on the sample sample that agree with one another
PRECISION
the degree by which a method is easily repeated
PRACTICABILITY
SOLUTION OF KNOWN CONCENTRATION
STANDARD
intervals with accepted values with upper or low limits
CONTROL LIMITS
constant result (on the sample) after repeated test
PRECISION or REPRODUCIBILITY
ability of an analytical method to maintain accuracy and precision over an extended period of time
RELIABILITY
lowest amount of analyte accurately detected by method
LIMIT OF DETECTION
range of analyte that a method can quantitatively report allowing dilution, concentration, pretreatment to extend AMR
CLINICAL REPORTABLE RANGE
ability of an analytical method to **DETECT THE PROPORTION OF INDIVIDUALS WITH THE DISEASE ** 🤕
DIAGNOSTIC SENSITIVITY
range of analyte concentration that is DIRECTLY MEASURED WITHOUT ❗ DILUTION, CONCENTRATION, AND PRETREATMENT
ANALYTIC MEASUREMENT RANGE (AMR)
quantifies how useful a test is
DIAGNOSTIC EFFICACY
common cause of IMPRECISION
ERRORS IN TECHNIQUE
common cause of INACCURACY
CHANGE IN TESTING PROCESS
common cause of RANDOM ERRORS
POOR TECHNIQUE and MALFUNCTIONING EQUIPMENT
random error is…
IMPRECISION
systematic error is…
INACCURACY
involves the analysis of 2 LEVELS OF CONTROL EVERY 24 HOURS
INTERNAL QUALITY CONTROL
initial control limits are established by analyzing controls for AT LEAST 20 CONSECUTIVE DAYS OR RUNS
IQC
important for the DAILY MONITORING of accuracy and precision of analytical methods
IQC
involves testing blind samples (uknown conc of analytes) sent periodically by regulatory agencies to participating laboratories
EXTERNAL QUALITY ASSESSMENT
important for the LONG-TERM ACCURACY of analytical methods
EXTERNAL QUALITY ASSESSMENT
include test requisition, px preparation, px ID, spx collection, labeling, spx transport, spx reception, handling and preparation
PRE-ANALYTICAL
include reagents, preventive maintenance of equipment, calibration, analysis of samples, and QC
ANALYTICAL
include verification of calculations and reference ranges, flagging and notification of panic/critical values, delta checks, reporting of results, and interpretation
POST-ANALYTICAL
an algorithm in which a current laboratory result is COMPARED WITH RESULTS OBTAINED ON A PREVIOUS SPECIMEN from the SAME PX
DELTA CHECK
PROBABILITY of an individual HAVING THE DISEASE if the result is abnormal
POSITIVE PREDICTED VALUE
PROBABILITY of an individual WITHOUT HAVING THE DISEASE if the result is within the reference range
NEGATIVE PREDICTIVE VALUE
a CUSTOMER-DRIVEN quality improvement through work monitoring, detecting deficiencies, and correcting them
TOTAL QUALITY MANAGEMENT (TQM)
management process to continue providing healthcare services to cater the px’s needs
CONTINUOUS QUALITY IMPROVEMENT (CQI)
DMAIC
DEFINE, MEASURE, ANALYZE, IMPROVE, CONTROL
FOCUS
FIND, ORGANIZE, CLARIFY, UNDERSTAND, SELECT
PDSA
PLAN, DO, STUDY, ACT
PDCA
PLAN, DO, CHECK, ACT
QMS
QUALITY MANAGEMENT SYSTEM
CQI
CONTINUOUS QUALITY IMPROVEMENT
TQM
TOTAL QUALITY MANAGEMENT
NFPA
NATIONAL FIRE PROTECTION ASSOCIATION
OSHA
OCCUPATIONAL SAFETY and HEALTH ADMINISTRATION
CLIA ‘88/1988
CLINICAL LABORATORY IMPROVEMENT AMENDMENT
OSHA 1983
HAZARD COMMUNICATION STANDARDS
OSHA 1991
BLOOD PATHOGEN STANDARDS
OSHA 1990
OCCUPATIONAL EXPOSURE TO HAZARDOUS CHEMICALS IN THE LABORATORY
EQAS
EXTERNAL QUALITY ASSURANCE SERVICES
NEQAS
NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME
a set of management practices that AIM TO IMPROVE EFFICIENCY and REDUCE WASTE
LEAN
a framework for improving quality, efficiency, and performance in a process management system
SIX SIGMA
is a TEAM-FOCUSED MANAGERIAL APPROACH that seeks to improve performance by ELIMINATING WASTE AND DEFECTS
LEAN SIX SIGMA
LSS (LEAN SIX SIGMA) STEPS
DMAIC
DMADV
DEFINE, MEASURE, ANALYZE, DESIGN, VERIFY
the simplest statistic used to describe the SPREAD OF DATA ABOUT THE MEAN
RANGE
it is calculated by subtracting the smallest observation or value from the largest
RANGE
it is the MOST COMMONLY USED statistic in the laboratory setting DESCRIBING THE DISPERSION OF GROUPS OF SINGLE OBSERVATIONS
STANDARD DEVIATION
is a comparison of the relative variability in two sets of values
CV
a plot that COMPARES RESULTS OBTAINED FROM DIFFERENT LABS
YOUDEN/TWIN
uses V-Mask for EARLIEST INDICATION OF SYSTEMATIC ERROR (TREND)
CUMULATIVE SUM (CUSUM)
a graphic representation of the acceptable limits of variation
SHEWHART LEVY-JENNINGS