QUALITY MANAGEMENT SYSTEM Flashcards
Most widely used approach to quality improvement in healthcare.
PDCA cycle
Management philosophy and process aimed at improving quality in all aspects of work.
Total Quality Management (TQM)
Framework component necessary to standardize remedies, establish performance measures, and ensure quality requirements are satisfied.
Quality Planning (QP)
Framework component defining processes, policies, practices, and procedures for all work aspects.
Quality Laboratory Processes (QLP)
Statistical control procedures and non-statistical checks like linearity checks and temperature monitors.
Quality Control (QC)
Broad measures of laboratory performance including TAT, patient identification, and specimen collection.
Quality Assurance (QA)
Structured problem-solving process for identifying root causes and remedies for problems.
Quality Improvement (QI)
Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.
Six Sigma
Indicators of Six Sigma performance improvement.
Improved performance, quality, bottom line, customer, and employee satisfaction
Five steps of Six Sigma (DMAIC).
Define, Measure, Analyze, Improve, Control
Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.
Lean
Lean categories of waste.
Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing
Lean-Six Sigma belt designation for those who understand the basics.
Yellow Belt
Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.
Green Belt
Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.
Black Belt
Lean-Six Sigma belt designation for experienced advisers and coaches.
Master Black Belt
Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.
Quality Assessment/Quality Assurance
Phase involving test requisition, patient preparation, specimen collection, and transport.
Pre-analytical
Phase involving reagents, equipment maintenance, calibration, and quality control.
Analytical
Phase involving calculation verification, delta checks, reporting, and interpretation.
Post-analytical
Algorithm comparing current lab results to previous results from the same patient.
Delta Check
Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.
Six Sigma
Indicators of Six Sigma performance improvement.
Improved performance, quality, bottom line, customer, and employee satisfaction
Five steps of Six Sigma (DMAIC).
Define, Measure, Analyze, Improve, Control
Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.
Lean
Lean categories of waste.
Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing
Lean-Six Sigma belt designation for those who understand the basics.
Yellow Belt
Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.
Green Belt
Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.
Black Belt
Lean-Six Sigma belt designation for experienced advisers and coaches.
Master Black Belt
Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.
Quality Assessment/Quality Assurance
Phase involving test requisition, patient preparation, specimen collection, and transport.
Pre-analytical
Phase involving reagents, equipment maintenance, calibration, and quality control.
Analytical
Phase involving calculation verification, delta checks, reporting, and interpretation.
Post-analytical
Algorithm comparing current lab results to previous results from the same patient.
Delta Check
Lean-Six Sigma belt between Yellow and Green belts.
Blue Belt
Phase where errors like inappropriate test requests, illegible handwriting, and delayed orders occur.
Pre-analytical
Phase where errors like incorrect tube, patient ID, or specimen volume occur.
Specimen acquisition (Pre-analytical)
Phase with issues like instrument calibration problems, interfering substances, or contaminated controls.
Analytical measurement
Phase where poorly written procedures and reagent deterioration can affect results.
Analytical measurement
Phase where errors like illegible, delayed, or incorrect transcription of reports occur.
Test reporting (Post-analytical)
Phase where interfering substances are not recognized or precision limitations are overlooked.
Test interpretation (Post-analytical)
Error in the pre-analytical phase caused by incorrect specimen transport conditions.
Improper transport conditions
Analytical phase error caused by poorly written procedures and calibration errors.
Instrument not calibrated correctly
Post-analytical error when previous values are unavailable for comparison.
Previous values not available
Phase where incorrect specimen collection time or conditions affect results.
Specimen acquisition (Pre-analytical)
Error caused by contaminated control solutions or deteriorating reagents.
Analytical measurement
Phase with errors involving inappropriate sensitivity, specificity, or recognition of test limitations.
Test interpretation (Post-analytical)
Ability to maintain accuracy and precision over an extended period despite changes in equipment, reagents, and personnel.
Reliability
Closeness of a result to the true or actual value.
Accuracy
Ability to produce closely agreeing results, expressed as coefficient of variation.
Precision
Type of precision measured within a single run.
Repeatability (Within-run precision)
Precision measured between runs or laboratories.
Reproducibility (Between-run/Interlab precision)
Number of control levels analyzed daily in internal quality control.
At least 2 levels every 24 hours
Duration required to establish initial control limits in internal QC.
At least 20 consecutive days or runs
Blind samples periodically sent to laboratories to test performance.
External Quality Assessment/Proficiency Testing (NEQAS)
Regulatory body sending unknown concentration analytes to participating laboratories.
National Reference Laboratory
Formula for the standard deviation index (SDI).
(Lab Result − Group Mean) / Group SD
SDI value indicating poor laboratory performance.
SDI > 2
Error caused by unpredictable chance events, affecting precision.
Random Error
Westgard rules violated by random error.
1(2s), 1(3s), R(4s)
Example causes of random error.
Improper sample mixing, pipetting error, temperature fluctuations
Error that occurs in a predictable pattern, influencing results in one direction.
Systematic Error
Westgard rules violated by systematic error.
2(2s), 4(1s), 8(1s), 10(mean)
Systematic error affecting all results regardless of analyte concentration.
Constant Error
Systematic error proportional to the analyte concentration.
Proportional Error
Examples of causes for systematic error.
Reagent deterioration, calibration error, dirty photometer
Type of error caused by faulty instrument stability, e.g., voltage fluctuations.
Random Error
Type of error resulting from contaminated control solutions or unstable reagent blanks.
Systematic Error
Abrupt change in control values accumulating on one side of the mean for 6 consecutive days; indicates systematic error.
Shift
Gradual change in control values increasing or decreasing over 6 consecutive days, passing through the mean; indicates reagent deterioration.
Trend
Highly deviating control values caused by random or systematic errors.
Outliers
Chart that plots the algebraic sum of differences between QC results and the mean on the y-axis against the run number on the x-axis.
CUSUM Chart
Plot used for interlaboratory comparison of monthly means by plotting one sample’s mean on the y-axis and another sample’s mean on the x-axis.
Tonks-Youden Plot
Major cause of a shift pattern in QC charts.
Calibration error or standard solutions
Major cause of a trend pattern in QC charts.
Systematic deterioration of reagents
Most commonly used QC chart.
Shewhart Levey-Jennings Chart
Rule where one control value exceeds ±2 SDs from the target value; serves as a warning rule.
1(2s)
Rule where one control value exceeds ±3 SDs from the target value; indicates random error.
1(3s)
Rule where the range between two control levels within a run exceeds 4 SDs; indicates random error.
R(4s)
Rule where two consecutive values or two QC samples exceed 2 SDs in the same direction; indicates bias.
2(2s)
Rule where four consecutive control values exceed 1 SD from the target value; indicates bias trend.
4(1s)
Rule where ten consecutive control values are on the same side of the mean; indicates bias trend.
10x̅
Rule where eight consecutive values for the same QC sample exceed 1 SD in the same direction; indicates bias trend and rejects the run.
8(1s)
Chart that uses cumulative sum of SDI to monitor systematic errors.
CUSUM
Chart that uses exponentially weighted moving averages to detect trends and biases.
EWMA
Rule where two out of three control values exceed the same mean ±2 SDs; rejects the run.
2 of 3(2s)
Rule where three consecutive control values exceed the same mean ±1 SD; rejects the run.
3(1s)
Rule where six consecutive control values are on the same side of the mean; rejects the run.
6x̅
Error type indicated by 1(2s), 1(3s), and R(4s) rules.
Random error
Error type indicated by 2(2s) rule.
Bias
Error type indicated by 4(1s) and 10x̅ rules.
Bias trend
Error type indicated by 8(1s), CUSUM, and EWMA charts.
Bias trend
Decision for a run when the 1(2s) rule is triggered.
Accept the run
Decision for a run when other Westgard rules are triggered.
Reject the run
Hierarchy of controls from most effective to least effective.
Elimination, Substitution, Engineering controls, Administrative controls, PPE
Action to physically remove a hazard in the workplace.
Elimination
Action to replace a hazard with a less dangerous one.
Substitution
Action to isolate people from a hazard using physical barriers or other engineering solutions.
Engineering controls
Action to change the way people work to reduce exposure to hazards.
Administrative controls
Action to protect workers using gear like gloves, gowns, and masks.
PPE
Most important means of preventing the spread of infection in a laboratory setting.
Hand washing
CDC guideline for proper handwashing duration.
At least 30 seconds
Correct sequence of donning PPE.
Gown, Mask/Respirator, Goggles, Gloves
Correct sequence of doffing PPE.
Gloves, Goggles, Gown, Mask
Type of biosafety cabinet that sterilizes only the air to be exhausted and does not protect the work surface.
Class I
Biosafety cabinet used in microbiology to sterilize air flowing over infectious material and to be exhausted.
Class II
Biosafety cabinet providing the highest level of personnel protection and used for extremely hazardous organisms.
Class III
Decontamination solution for body fluid spills in the lab.
5.25% NaOCl or 10% chlorine bleach (1:10 dilution)
First step in the protocol for managing blood spills in the laboratory.
Wear gloves and a laboratory coat
Action to take after absorbing liquid blood or serum from a spill.
Clean the spill site with a diluted bleach solution
Action to take with disposable materials used for decontamination after a spill.
Place in a biohazard container
How to decontaminate non-disposable equipment after a body fluid spill.
Soak overnight in diluted bleach, rinse with methyl alcohol and water
How to dispose of disposable glassware or supplies that have come in contact with blood.
Autoclave or incinerate
Radiation with wavelength less than 400 nm used in biologic safety cabinets for germicidal purposes.
Ultraviolet
Wavelength range for general illumination.
400–700 nm (Visible spectrum)
Radiation with wavelength greater than 700 nm used for heat lamps, lasers, and vein selectors.
Infrared
Wavelength range for microwave energy used to accelerate tissue staining.
3 µm–3 mm (Microwaves)
Radiation with frequency greater than 1 cm used in radiofrequency coils in ICP–MS.
Low frequency
Used for materials that give off harmful vapors and provides personnel protection only.
Fume hood
Formerly known as MSDS, a major source of information about chemicals written by manufacturers; revised format consists of 16 sections.
SDS
Section in SDS that provides information about the chemical’s identity, such as its name, synonyms, and recommended uses.
1: Identification
Section in SDS that provides information on the hazards associated with the chemical, such as toxicity or environmental impact.
2: Hazard identification
Section in SDS that contains details about the chemical ingredients in the product.
3: Ingredients information
Section in SDS that provides procedures for handling the chemical in case of exposure or ingestion.
4: First aid procedures
Section in SDS that provides firefighting guidelines for the chemical.
5: Fire-fighting procedures
Section in SDS that outlines measures to be taken in case of an accidental release of the chemical.
6: Accidental-release measures
Section in SDS that provides guidelines on the proper handling and storage of the chemical.
7: Handling and storage
Section in SDS that details the exposure controls and personal protection for the chemical, including TLV and PEL.
8: Exposure controls and personal protection
Term for a chemical property where the substance absorbs water when exposed to air.
Hygroscopic
Section in SDS that provides information about the chemical’s stability and reactivity.
10: Stability and reactivity
Section in SDS that provides toxicological information, including potential effects such as carcinogenicity, mutagenicity, or teratogenicity.
11: Toxicological information
Section in SDS that provides guidelines for ecological impact and safe disposal of the chemical.
12: Ecological information
Section in SDS that provides guidelines for proper chemical disposal.
13: Disposal considerations
Section in SDS that provides information on the transport regulations of the chemical.
14: Transport information
Section in SDS that outlines the regulatory requirements related to the chemical.
15: Regulatory information
Section in SDS that contains any additional information not included in the previous sections.
16: Other information
Health hazard classification with the highest level of danger, potentially deadly.
4 - Deadly
Health hazard classification indicating extreme danger.
3 - Extreme danger
Health hazard classification indicating hazardous material.
2 - Hazardous
Health hazard classification indicating slightly hazardous material.
1 - Slightly hazardous
Health hazard classification indicating a normal, non-hazardous material.
0 - Normal material
Fire hazard classification for a material with a flashpoint below 73°F.
4 - Below 73°F
Fire hazard classification for a material with a flashpoint below 100°F.
3 - Below 100°F
Fire hazard classification for a material with a flashpoint below 200°F.
2 - Below 200°F
Fire hazard classification for a material with a flashpoint above 200°F.
1 - Above 200°F
Fire hazard classification for a material that will not burn.
0 - Will not burn
Specific hazard indicating an oxidizer.
Oxy - Oxidizer
Specific hazard indicating an acid.
ACD - Acid
Specific hazard indicating an alkali.
Alk - Alkali
Specific hazard indicating a corrosive material.
Cor - Corrosive
Specific hazard indicating a material that reacts with water.
W - White line (Water reaction)
Specific hazard indicating nuclear radiation risk.
Radiation - Nuclear sign
Reactivity classification indicating that the material may detonate.
4 - May detonate
Reactivity classification indicating that shock and heat may detonate the material.
3 - Shock and heat may detonate
Reactivity classification indicating a violent chemical change.
2 - Violent chemical change
Reactivity classification indicating instability if heated.
1 - Unstable if heated
Reactivity classification indicating stability.
0 - Stable
Action steps in the event of a fire: Rescue, Alarm, Contain, Extinguish/Evacuate.
Fire hazard actions
Steps for operating a fire extinguisher.
Pull pin, Aim nozzle, Squeeze trigger, Sweep nozzle
Class of combustibles that includes ordinary materials like wood, paper, and cloth.
A - Ordinary combustibles
Extinguishers used for Class A fires (ordinary combustibles).
Pressurized water (A), Dry chemical (ABC)
Class of combustibles that includes flammable liquids like grease, gasoline, and paints.
B - Flammable liquids
Extinguishers used for Class B fires (flammable liquids).
Dry chemical, Carbon dioxide (BC), Halon
Class of combustibles that includes electrical equipment like motors and switches.
C - Electrical equipment
Extinguishers used for Class C fires (electrical equipment).
Dry chemical, Carbon dioxide, Halon
Class of combustibles that includes flammable metals like magnesium and sodium.
D - Flammable metals
Extinguishers used for Class D fires (flammable metals).
Metal X (special dry chemical) or sand
Class of combustibles for materials that may result in detonation, which cannot be extinguished.
E - Arsenal or materials liable to detonation
Class of fire hazard for combustible cooking media, like oils and fats in commercial kitchens.
K - Combustible cooking media
Extinguisher used for Class K fires (combustible cooking media).
Liquid designed to prevent splashing and cool the fire
