QUALITY MANAGEMENT SYSTEM Flashcards
1
Q
Most widely used approach to quality improvement in healthcare.
A
PDCA cycle
2
Q
Management philosophy and process aimed at improving quality in all aspects of work.
A
Total Quality Management (TQM)
3
Q
Framework component necessary to standardize remedies, establish performance measures, and ensure quality requirements are satisfied.
A
Quality Planning (QP)
4
Q
Framework component defining processes, policies, practices, and procedures for all work aspects.
A
Quality Laboratory Processes (QLP)
5
Q
Statistical control procedures and non-statistical checks like linearity checks and temperature monitors.
A
Quality Control (QC)
6
Q
Broad measures of laboratory performance including TAT, patient identification, and specimen collection.
A
Quality Assurance (QA)
7
Q
Structured problem-solving process for identifying root causes and remedies for problems.
A
Quality Improvement (QI)
8
Q
Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.
A
Six Sigma
9
Q
Indicators of Six Sigma performance improvement.
A
Improved performance, quality, bottom line, customer, and employee satisfaction
10
Q
Five steps of Six Sigma (DMAIC).
A
Define, Measure, Analyze, Improve, Control
11
Q
Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.
A
Lean
12
Q
Lean categories of waste.
A
Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing
13
Q
Lean-Six Sigma belt designation for those who understand the basics.
A
Yellow Belt
14
Q
Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.
A
Green Belt
15
Q
Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.
A
Black Belt
16
Q
Lean-Six Sigma belt designation for experienced advisers and coaches.
A
Master Black Belt
17
Q
Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.
A
Quality Assessment/Quality Assurance
18
Q
Phase involving test requisition, patient preparation, specimen collection, and transport.
A
Pre-analytical
19
Q
Phase involving reagents, equipment maintenance, calibration, and quality control.
A
Analytical
20
Q
Phase involving calculation verification, delta checks, reporting, and interpretation.
A
Post-analytical
21
Q
Algorithm comparing current lab results to previous results from the same patient.
A
Delta Check
22
Q
Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.
A
Six Sigma
23
Q
Indicators of Six Sigma performance improvement.
A
Improved performance, quality, bottom line, customer, and employee satisfaction
24
Q
Five steps of Six Sigma (DMAIC).
A
Define, Measure, Analyze, Improve, Control
25
Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.
Lean
26
Lean categories of waste.
Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing
27
Lean-Six Sigma belt designation for those who understand the basics.
Yellow Belt
28
Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.
Green Belt
29
Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.
Black Belt
30
Lean-Six Sigma belt designation for experienced advisers and coaches.
Master Black Belt
31
Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.
Quality Assessment/Quality Assurance
32
Phase involving test requisition, patient preparation, specimen collection, and transport.
Pre-analytical
33
Phase involving reagents, equipment maintenance, calibration, and quality control.
Analytical
34
Phase involving calculation verification, delta checks, reporting, and interpretation.
Post-analytical
35
Algorithm comparing current lab results to previous results from the same patient.
Delta Check
36
Lean-Six Sigma belt between Yellow and Green belts.
Blue Belt
37
Phase where errors like inappropriate test requests, illegible handwriting, and delayed orders occur.
Pre-analytical
38
Phase where errors like incorrect tube, patient ID, or specimen volume occur.
Specimen acquisition (Pre-analytical)
39
Phase with issues like instrument calibration problems, interfering substances, or contaminated controls.
Analytical measurement
40
Phase where poorly written procedures and reagent deterioration can affect results.
Analytical measurement
41
Phase where errors like illegible, delayed, or incorrect transcription of reports occur.
Test reporting (Post-analytical)
42
Phase where interfering substances are not recognized or precision limitations are overlooked.
Test interpretation (Post-analytical)
43
Error in the pre-analytical phase caused by incorrect specimen transport conditions.
Improper transport conditions
44
Analytical phase error caused by poorly written procedures and calibration errors.
Instrument not calibrated correctly
45
Post-analytical error when previous values are unavailable for comparison.
Previous values not available
46
Phase where incorrect specimen collection time or conditions affect results.
Specimen acquisition (Pre-analytical)
47
Error caused by contaminated control solutions or deteriorating reagents.
Analytical measurement
48
Phase with errors involving inappropriate sensitivity, specificity, or recognition of test limitations.
Test interpretation (Post-analytical)
49
Ability to maintain accuracy and precision over an extended period despite changes in equipment, reagents, and personnel.
Reliability
50
Closeness of a result to the true or actual value.
Accuracy
51
Ability to produce closely agreeing results, expressed as coefficient of variation.
Precision
52
Type of precision measured within a single run.
Repeatability (Within-run precision)
53
Precision measured between runs or laboratories.
Reproducibility (Between-run/Interlab precision)
54
Number of control levels analyzed daily in internal quality control.
At least 2 levels every 24 hours
55
Duration required to establish initial control limits in internal QC.
At least 20 consecutive days or runs
56
Blind samples periodically sent to laboratories to test performance.
External Quality Assessment/Proficiency Testing (NEQAS)
57
Regulatory body sending unknown concentration analytes to participating laboratories.
National Reference Laboratory
58
Formula for the standard deviation index (SDI).
(Lab Result − Group Mean) / Group SD
59
SDI value indicating poor laboratory performance.
SDI > 2
60
Error caused by unpredictable chance events, affecting precision.
Random Error
61
Westgard rules violated by random error.
1(2s), 1(3s), R(4s)
62
Example causes of random error.
Improper sample mixing, pipetting error, temperature fluctuations
63
Error that occurs in a predictable pattern, influencing results in one direction.
Systematic Error
64
Westgard rules violated by systematic error.
2(2s), 4(1s), 8(1s), 10(mean)
65
Systematic error affecting all results regardless of analyte concentration.
Constant Error
66
Systematic error proportional to the analyte concentration.
Proportional Error
67
Examples of causes for systematic error.
Reagent deterioration, calibration error, dirty photometer
68
Type of error caused by faulty instrument stability, e.g., voltage fluctuations.
Random Error
69
Type of error resulting from contaminated control solutions or unstable reagent blanks.
Systematic Error
70
**Abrupt change** in control values accumulating on **one side of the mean** for 6 consecutive days; indicates systematic error.
Shift
71
Gradual change in control values increasing or decreasing over 6 consecutive days, **passing through the mean**; indicates reagent deterioration.
Trend
72
Highly deviating control values caused by random or systematic errors.
Outliers
73
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
74
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
75
Major cause of a shift pattern in QC charts.
Calibration error or standard solutions
76
Major cause of a trend pattern in QC charts.
Systematic deterioration of reagents
77
Most commonly used QC chart.
Shewhart Levey-Jennings Chart
78
Rule where one control value exceeds ±2 SDs from the target value; serves as a warning rule.
1(2s)
79
Rule where one control value exceeds ±3 SDs from the target value; indicates random error.
1(3s)
80
Rule where the range between two control levels within a run exceeds 4 SDs; indicates random error.
R(4s)
81
Rule where two consecutive values or two QC samples exceed 2 SDs in the same direction; indicates bias.
2(2s)
82
Rule where four consecutive control values exceed 1 SD from the target value; indicates bias trend.
4(1s)
83
Rule where ten consecutive control values are on the same side of the mean; indicates bias trend.
10x̅
84
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)
85
Chart that uses cumulative sum of SDI to monitor systematic errors.
CUSUM
86
Chart that uses exponentially weighted moving averages to detect trends and biases.
EWMA
87
Rule where two out of three control values exceed the same mean ±2 SDs; rejects the run.
2 of 3(2s)
88
Rule where three consecutive control values exceed the same mean ±1 SD; rejects the run.
3(1s)
89
Rule where six consecutive control values are on the same side of the mean; rejects the run.
6x̅
90
Error type indicated by 1(2s), 1(3s), and R(4s) rules.
Random error
91
Error type indicated by 2(2s) rule.
Bias
92
Error type indicated by 4(1s) and 10x̅ rules.
Bias trend
93
Error type indicated by 8(1s), CUSUM, and EWMA charts.
Bias trend
94
Decision for a run when the 1(2s) rule is triggered.
Accept the run
95
Decision for a run when other Westgard rules are triggered.
Reject the run
96
Hierarchy of controls from most effective to least effective.
Elimination, Substitution, Engineering controls, Administrative controls, PPE
97
Action to physically remove a hazard in the workplace.
Elimination
98
Action to replace a hazard with a less dangerous one.
Substitution
99
Action to isolate people from a hazard using physical barriers or other engineering solutions.
Engineering controls
100
Action to change the way people work to reduce exposure to hazards.
Administrative controls
101
Action to protect workers using gear like gloves, gowns, and masks.
PPE
102
Most important means of preventing the spread of infection in a laboratory setting.
Hand washing
103
CDC guideline for proper handwashing duration.
At least 30 seconds
104
Correct sequence of donning PPE.
Gown, Mask/Respirator, Goggles, Gloves
105
Correct sequence of doffing PPE.
Gloves, Goggles, Gown, Mask
106
Type of biosafety cabinet that sterilizes only the air to be exhausted and does not protect the work surface.
Class I
107
Biosafety cabinet used in microbiology to sterilize air flowing over infectious material and to be exhausted.
Class II
108
Biosafety cabinet providing the highest level of personnel protection and used for extremely hazardous organisms.
Class III
109
Decontamination solution for body fluid spills in the lab.
5.25% NaOCl or 10% chlorine bleach (1:10 dilution)
110
First step in the protocol for managing blood spills in the laboratory.
Wear gloves and a laboratory coat
111
Action to take after absorbing liquid blood or serum from a spill.
Clean the spill site with a diluted bleach solution
112
Action to take with disposable materials used for decontamination after a spill.
Place in a biohazard container
113
How to decontaminate non-disposable equipment after a body fluid spill.
Soak overnight in diluted bleach, rinse with methyl alcohol and water
114
How to dispose of disposable glassware or supplies that have come in contact with blood.
Autoclave or incinerate
115
Radiation with wavelength less than 400 nm used in biologic safety cabinets for germicidal purposes.
Ultraviolet
116
Wavelength range for general illumination.
400–700 nm (Visible spectrum)
117
Radiation with wavelength greater than 700 nm used for heat lamps, lasers, and vein selectors.
Infrared
118
Wavelength range for microwave energy used to accelerate tissue staining.
3 µm–3 mm (Microwaves)
119
Radiation with frequency greater than 1 cm used in radiofrequency coils in ICP–MS.
Low frequency
120
Used for materials that give off harmful vapors and provides personnel protection only.
Fume hood
121
Formerly known as MSDS, a major source of information about chemicals written by manufacturers; revised format consists of 16 sections.
SDS
122
Section in SDS that provides information about the chemical's identity, such as its name, synonyms, and recommended uses.
1: Identification
123
Section in SDS that provides information on the hazards associated with the chemical, such as toxicity or environmental impact.
2: Hazard identification
124
Section in SDS that contains details about the chemical ingredients in the product.
3: Ingredients information
125
Section in SDS that provides procedures for handling the chemical in case of exposure or ingestion.
4: First aid procedures
126
Section in SDS that provides firefighting guidelines for the chemical.
5: Fire-fighting procedures
127
Section in SDS that outlines measures to be taken in case of an accidental release of the chemical.
6: Accidental-release measures
128
Section in SDS that provides guidelines on the proper handling and storage of the chemical.
7: Handling and storage
129
Section in SDS that details the exposure controls and personal protection for the chemical, including TLV and PEL.
8: Exposure controls and personal protection
130
Term for a chemical property where the substance absorbs water when exposed to air.
Hygroscopic
131
Section in SDS that provides information about the chemical's stability and reactivity.
10: Stability and reactivity
132
Section in SDS that provides toxicological information, including potential effects such as carcinogenicity, mutagenicity, or teratogenicity.
11: Toxicological information
133
Section in SDS that provides guidelines for ecological impact and safe disposal of the chemical.
12: Ecological information
134
Section in SDS that provides guidelines for proper chemical disposal.
13: Disposal considerations
135
Section in SDS that provides information on the transport regulations of the chemical.
14: Transport information
136
Section in SDS that outlines the regulatory requirements related to the chemical.
15: Regulatory information
137
Section in SDS that contains any additional information not included in the previous sections.
16: Other information
138
Health hazard classification with the highest level of danger, potentially deadly.
4 - Deadly
139
Health hazard classification indicating extreme danger.
3 - Extreme danger
140
Health hazard classification indicating hazardous material.
2 - Hazardous
141
Health hazard classification indicating slightly hazardous material.
1 - Slightly hazardous
142
Health hazard classification indicating a normal, non-hazardous material.
0 - Normal material
143
Fire hazard classification for a material with a flashpoint below 73°F.
4 - Below 73°F
144
Fire hazard classification for a material with a flashpoint below 100°F.
3 - Below 100°F
145
Fire hazard classification for a material with a flashpoint below 200°F.
2 - Below 200°F
146
Fire hazard classification for a material with a flashpoint above 200°F.
1 - Above 200°F
147
Fire hazard classification for a material that will not burn.
0 - Will not burn
148
Specific hazard indicating an oxidizer.
Oxy - Oxidizer
149
Specific hazard indicating an acid.
ACD - Acid
150
Specific hazard indicating an alkali.
Alk - Alkali
151
Specific hazard indicating a corrosive material.
Cor - Corrosive
152
Specific hazard indicating a material that reacts with water.
W - White line (Water reaction)
153
Specific hazard indicating nuclear radiation risk.
Radiation - Nuclear sign
154
Reactivity classification indicating that the material may detonate.
4 - May detonate
155
Reactivity classification indicating that shock and heat may detonate the material.
3 - Shock and heat may detonate
156
Reactivity classification indicating a violent chemical change.
2 - Violent chemical change
157
Reactivity classification indicating instability if heated.
1 - Unstable if heated
158
Reactivity classification indicating stability.
0 - Stable
159
Action steps in the event of a fire: Rescue, Alarm, Contain, Extinguish/Evacuate.
Fire hazard actions
160
Steps for operating a fire extinguisher.
Pull pin, Aim nozzle, Squeeze trigger, Sweep nozzle
161
Class of combustibles that includes ordinary materials like wood, paper, and cloth.
A - Ordinary combustibles
162
Extinguishers used for Class A fires (ordinary combustibles).
Pressurized water (A), Dry chemical (ABC)
163
Class of combustibles that includes flammable liquids like grease, gasoline, and paints.
B - Flammable liquids
164
Extinguishers used for Class B fires (flammable liquids).
Dry chemical, Carbon dioxide (BC), Halon
165
Class of combustibles that includes electrical equipment like motors and switches.
C - Electrical equipment
166
Extinguishers used for Class C fires (electrical equipment).
Dry chemical, Carbon dioxide, Halon
167
Class of combustibles that includes flammable metals like magnesium and sodium.
D - Flammable metals
168
Extinguishers used for Class D fires (flammable metals).
Metal X (special dry chemical) or sand
169
Class of combustibles for materials that may result in detonation, which cannot be extinguished.
E - Arsenal or materials liable to detonation
170
Class of fire hazard for combustible cooking media, like oils and fats in commercial kitchens.
K - Combustible cooking media
171
Extinguisher used for Class K fires (combustible cooking media).
Liquid designed to prevent splashing and cool the fire
