QUALITY MANAGEMENT SYSTEM Flashcards

1
Q

Most widely used approach to quality improvement in healthcare.

A

PDCA cycle

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2
Q

Management philosophy and process aimed at improving quality in all aspects of work.

A

Total Quality Management (TQM)

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3
Q

Framework component necessary to standardize remedies, establish performance measures, and ensure quality requirements are satisfied.

A

Quality Planning (QP)

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4
Q

Framework component defining processes, policies, practices, and procedures for all work aspects.

A

Quality Laboratory Processes (QLP)

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5
Q

Statistical control procedures and non-statistical checks like linearity checks and temperature monitors.

A

Quality Control (QC)

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6
Q

Broad measures of laboratory performance including TAT, patient identification, and specimen collection.

A

Quality Assurance (QA)

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7
Q

Structured problem-solving process for identifying root causes and remedies for problems.

A

Quality Improvement (QI)

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8
Q

Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.

A

Six Sigma

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9
Q

Indicators of Six Sigma performance improvement.

A

Improved performance, quality, bottom line, customer, and employee satisfaction

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10
Q

Five steps of Six Sigma (DMAIC).

A

Define, Measure, Analyze, Improve, Control

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11
Q

Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.

A

Lean

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12
Q

Lean categories of waste.

A

Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing

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13
Q

Lean-Six Sigma belt designation for those who understand the basics.

A

Yellow Belt

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14
Q

Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.

A

Green Belt

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15
Q

Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.

A

Black Belt

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16
Q

Lean-Six Sigma belt designation for experienced advisers and coaches.

A

Master Black Belt

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17
Q

Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.

A

Quality Assessment/Quality Assurance

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18
Q

Phase involving test requisition, patient preparation, specimen collection, and transport.

A

Pre-analytical

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19
Q

Phase involving reagents, equipment maintenance, calibration, and quality control.

A

Analytical

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20
Q

Phase involving calculation verification, delta checks, reporting, and interpretation.

A

Post-analytical

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21
Q

Algorithm comparing current lab results to previous results from the same patient.

A

Delta Check

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22
Q

Approach based on statistics and quantitative measurements to reduce test errors or DPMOs.

A

Six Sigma

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23
Q

Indicators of Six Sigma performance improvement.

A

Improved performance, quality, bottom line, customer, and employee satisfaction

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24
Q

Five steps of Six Sigma (DMAIC).

A

Define, Measure, Analyze, Improve, Control

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25
Q

Approach designed to reduce waste, increase efficiency, and improve customer satisfaction.

A

Lean

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26
Q

Lean categories of waste.

A

Defects, overproduction, waiting, non-utilized talent, transport, poor inventory, excess motion, excess processing

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27
Q

Lean-Six Sigma belt designation for those who understand the basics.

A

Yellow Belt

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28
Q

Lean-Six Sigma belt designation for team members contributing 20% of their time to QI projects.

A

Green Belt

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29
Q

Lean-Six Sigma belt designation for leaders dedicating 100% of their time to QI projects.

A

Black Belt

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30
Q

Lean-Six Sigma belt designation for experienced advisers and coaches.

A

Master Black Belt

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31
Q

Process ensuring quality results by monitoring preanalytical, analytical, and postanalytical phases.

A

Quality Assessment/Quality Assurance

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32
Q

Phase involving test requisition, patient preparation, specimen collection, and transport.

A

Pre-analytical

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33
Q

Phase involving reagents, equipment maintenance, calibration, and quality control.

A

Analytical

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34
Q

Phase involving calculation verification, delta checks, reporting, and interpretation.

A

Post-analytical

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35
Q

Algorithm comparing current lab results to previous results from the same patient.

A

Delta Check

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36
Q

Lean-Six Sigma belt between Yellow and Green belts.

A

Blue Belt

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37
Q

Phase where errors like inappropriate test requests, illegible handwriting, and delayed orders occur.

A

Pre-analytical

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38
Q

Phase where errors like incorrect tube, patient ID, or specimen volume occur.

A

Specimen acquisition (Pre-analytical)

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39
Q

Phase with issues like instrument calibration problems, interfering substances, or contaminated controls.

A

Analytical measurement

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40
Q

Phase where poorly written procedures and reagent deterioration can affect results.

A

Analytical measurement

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41
Q

Phase where errors like illegible, delayed, or incorrect transcription of reports occur.

A

Test reporting (Post-analytical)

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42
Q

Phase where interfering substances are not recognized or precision limitations are overlooked.

A

Test interpretation (Post-analytical)

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43
Q

Error in the pre-analytical phase caused by incorrect specimen transport conditions.

A

Improper transport conditions

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44
Q

Analytical phase error caused by poorly written procedures and calibration errors.

A

Instrument not calibrated correctly

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45
Q

Post-analytical error when previous values are unavailable for comparison.

A

Previous values not available

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46
Q

Phase where incorrect specimen collection time or conditions affect results.

A

Specimen acquisition (Pre-analytical)

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47
Q

Error caused by contaminated control solutions or deteriorating reagents.

A

Analytical measurement

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48
Q

Phase with errors involving inappropriate sensitivity, specificity, or recognition of test limitations.

A

Test interpretation (Post-analytical)

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49
Q

Ability to maintain accuracy and precision over an extended period despite changes in equipment, reagents, and personnel.

A

Reliability

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50
Q

Closeness of a result to the true or actual value.

A

Accuracy

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51
Q

Ability to produce closely agreeing results, expressed as coefficient of variation.

A

Precision

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52
Q

Type of precision measured within a single run.

A

Repeatability (Within-run precision)

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53
Q

Precision measured between runs or laboratories.

A

Reproducibility (Between-run/Interlab precision)

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54
Q

Number of control levels analyzed daily in internal quality control.

A

At least 2 levels every 24 hours

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55
Q

Duration required to establish initial control limits in internal QC.

A

At least 20 consecutive days or runs

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56
Q

Blind samples periodically sent to laboratories to test performance.

A

External Quality Assessment/Proficiency Testing (NEQAS)

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57
Q

Regulatory body sending unknown concentration analytes to participating laboratories.

A

National Reference Laboratory

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58
Q

Formula for the standard deviation index (SDI).

A

(Lab Result − Group Mean) / Group SD

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59
Q

SDI value indicating poor laboratory performance.

A

SDI > 2

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60
Q

Error caused by unpredictable chance events, affecting precision.

A

Random Error

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61
Q

Westgard rules violated by random error.

A

1(2s), 1(3s), R(4s)

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62
Q

Example causes of random error.

A

Improper sample mixing, pipetting error, temperature fluctuations

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63
Q

Error that occurs in a predictable pattern, influencing results in one direction.

A

Systematic Error

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64
Q

Westgard rules violated by systematic error.

A

2(2s), 4(1s), 8(1s), 10(mean)

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65
Q

Systematic error affecting all results regardless of analyte concentration.

A

Constant Error

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66
Q

Systematic error proportional to the analyte concentration.

A

Proportional Error

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67
Q

Examples of causes for systematic error.

A

Reagent deterioration, calibration error, dirty photometer

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68
Q

Type of error caused by faulty instrument stability, e.g., voltage fluctuations.

A

Random Error

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69
Q

Type of error resulting from contaminated control solutions or unstable reagent blanks.

A

Systematic Error

70
Q

Abrupt change in control values accumulating on one side of the mean for 6 consecutive days; indicates systematic error.

A

Shift

71
Q

Gradual change in control values increasing or decreasing over 6 consecutive days, passing through the mean; indicates reagent deterioration.

A

Trend

72
Q

Highly deviating control values caused by random or systematic errors.

A

Outliers

73
Q

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.

A

CUSUM Chart

74
Q

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.

A

Tonks-Youden Plot

75
Q

Major cause of a shift pattern in QC charts.

A

Calibration error or standard solutions

76
Q

Major cause of a trend pattern in QC charts.

A

Systematic deterioration of reagents

77
Q

Most commonly used QC chart.

A

Shewhart Levey-Jennings Chart

78
Q

Rule where one control value exceeds ±2 SDs from the target value; serves as a warning rule.

A

1(2s)

79
Q

Rule where one control value exceeds ±3 SDs from the target value; indicates random error.

A

1(3s)

80
Q

Rule where the range between two control levels within a run exceeds 4 SDs; indicates random error.

A

R(4s)

81
Q

Rule where two consecutive values or two QC samples exceed 2 SDs in the same direction; indicates bias.

A

2(2s)

82
Q

Rule where four consecutive control values exceed 1 SD from the target value; indicates bias trend.

A

4(1s)

83
Q

Rule where ten consecutive control values are on the same side of the mean; indicates bias trend.

A

10x̅

84
Q

Rule where eight consecutive values for the same QC sample exceed 1 SD in the same direction; indicates bias trend and rejects the run.

A

8(1s)

85
Q

Chart that uses cumulative sum of SDI to monitor systematic errors.

A

CUSUM

86
Q

Chart that uses exponentially weighted moving averages to detect trends and biases.

A

EWMA

87
Q

Rule where two out of three control values exceed the same mean ±2 SDs; rejects the run.

A

2 of 3(2s)

88
Q

Rule where three consecutive control values exceed the same mean ±1 SD; rejects the run.

A

3(1s)

89
Q

Rule where six consecutive control values are on the same side of the mean; rejects the run.

A

6x̅

90
Q

Error type indicated by 1(2s), 1(3s), and R(4s) rules.

A

Random error

91
Q

Error type indicated by 2(2s) rule.

A

Bias

92
Q

Error type indicated by 4(1s) and 10x̅ rules.

A

Bias trend

93
Q

Error type indicated by 8(1s), CUSUM, and EWMA charts.

A

Bias trend

94
Q

Decision for a run when the 1(2s) rule is triggered.

A

Accept the run

95
Q

Decision for a run when other Westgard rules are triggered.

A

Reject the run

96
Q

Hierarchy of controls from most effective to least effective.

A

Elimination, Substitution, Engineering controls, Administrative controls, PPE

97
Q

Action to physically remove a hazard in the workplace.

A

Elimination

98
Q

Action to replace a hazard with a less dangerous one.

A

Substitution

99
Q

Action to isolate people from a hazard using physical barriers or other engineering solutions.

A

Engineering controls

100
Q

Action to change the way people work to reduce exposure to hazards.

A

Administrative controls

101
Q

Action to protect workers using gear like gloves, gowns, and masks.

A

PPE

102
Q

Most important means of preventing the spread of infection in a laboratory setting.

A

Hand washing

103
Q

CDC guideline for proper handwashing duration.

A

At least 30 seconds

104
Q

Correct sequence of donning PPE.

A

Gown, Mask/Respirator, Goggles, Gloves

105
Q

Correct sequence of doffing PPE.

A

Gloves, Goggles, Gown, Mask

106
Q

Type of biosafety cabinet that sterilizes only the air to be exhausted and does not protect the work surface.

A

Class I

107
Q

Biosafety cabinet used in microbiology to sterilize air flowing over infectious material and to be exhausted.

A

Class II

108
Q

Biosafety cabinet providing the highest level of personnel protection and used for extremely hazardous organisms.

A

Class III

109
Q

Decontamination solution for body fluid spills in the lab.

A

5.25% NaOCl or 10% chlorine bleach (1:10 dilution)

110
Q

First step in the protocol for managing blood spills in the laboratory.

A

Wear gloves and a laboratory coat

111
Q

Action to take after absorbing liquid blood or serum from a spill.

A

Clean the spill site with a diluted bleach solution

112
Q

Action to take with disposable materials used for decontamination after a spill.

A

Place in a biohazard container

113
Q

How to decontaminate non-disposable equipment after a body fluid spill.

A

Soak overnight in diluted bleach, rinse with methyl alcohol and water

114
Q

How to dispose of disposable glassware or supplies that have come in contact with blood.

A

Autoclave or incinerate

115
Q

Radiation with wavelength less than 400 nm used in biologic safety cabinets for germicidal purposes.

A

Ultraviolet

116
Q

Wavelength range for general illumination.

A

400–700 nm (Visible spectrum)

117
Q

Radiation with wavelength greater than 700 nm used for heat lamps, lasers, and vein selectors.

A

Infrared

118
Q

Wavelength range for microwave energy used to accelerate tissue staining.

A

3 µm–3 mm (Microwaves)

119
Q

Radiation with frequency greater than 1 cm used in radiofrequency coils in ICP–MS.

A

Low frequency

120
Q

Used for materials that give off harmful vapors and provides personnel protection only.

A

Fume hood

121
Q

Formerly known as MSDS, a major source of information about chemicals written by manufacturers; revised format consists of 16 sections.

A

SDS

122
Q

Section in SDS that provides information about the chemical’s identity, such as its name, synonyms, and recommended uses.

A

1: Identification

123
Q

Section in SDS that provides information on the hazards associated with the chemical, such as toxicity or environmental impact.

A

2: Hazard identification

124
Q

Section in SDS that contains details about the chemical ingredients in the product.

A

3: Ingredients information

125
Q

Section in SDS that provides procedures for handling the chemical in case of exposure or ingestion.

A

4: First aid procedures

126
Q

Section in SDS that provides firefighting guidelines for the chemical.

A

5: Fire-fighting procedures

127
Q

Section in SDS that outlines measures to be taken in case of an accidental release of the chemical.

A

6: Accidental-release measures

128
Q

Section in SDS that provides guidelines on the proper handling and storage of the chemical.

A

7: Handling and storage

129
Q

Section in SDS that details the exposure controls and personal protection for the chemical, including TLV and PEL.

A

8: Exposure controls and personal protection

130
Q

Term for a chemical property where the substance absorbs water when exposed to air.

A

Hygroscopic

131
Q

Section in SDS that provides information about the chemical’s stability and reactivity.

A

10: Stability and reactivity

132
Q

Section in SDS that provides toxicological information, including potential effects such as carcinogenicity, mutagenicity, or teratogenicity.

A

11: Toxicological information

133
Q

Section in SDS that provides guidelines for ecological impact and safe disposal of the chemical.

A

12: Ecological information

134
Q

Section in SDS that provides guidelines for proper chemical disposal.

A

13: Disposal considerations

135
Q

Section in SDS that provides information on the transport regulations of the chemical.

A

14: Transport information

136
Q

Section in SDS that outlines the regulatory requirements related to the chemical.

A

15: Regulatory information

137
Q

Section in SDS that contains any additional information not included in the previous sections.

A

16: Other information

138
Q

Health hazard classification with the highest level of danger, potentially deadly.

A

4 - Deadly

139
Q

Health hazard classification indicating extreme danger.

A

3 - Extreme danger

140
Q

Health hazard classification indicating hazardous material.

A

2 - Hazardous

141
Q

Health hazard classification indicating slightly hazardous material.

A

1 - Slightly hazardous

142
Q

Health hazard classification indicating a normal, non-hazardous material.

A

0 - Normal material

143
Q

Fire hazard classification for a material with a flashpoint below 73°F.

A

4 - Below 73°F

144
Q

Fire hazard classification for a material with a flashpoint below 100°F.

A

3 - Below 100°F

145
Q

Fire hazard classification for a material with a flashpoint below 200°F.

A

2 - Below 200°F

146
Q

Fire hazard classification for a material with a flashpoint above 200°F.

A

1 - Above 200°F

147
Q

Fire hazard classification for a material that will not burn.

A

0 - Will not burn

148
Q

Specific hazard indicating an oxidizer.

A

Oxy - Oxidizer

149
Q

Specific hazard indicating an acid.

A

ACD - Acid

150
Q

Specific hazard indicating an alkali.

A

Alk - Alkali

151
Q

Specific hazard indicating a corrosive material.

A

Cor - Corrosive

152
Q

Specific hazard indicating a material that reacts with water.

A

W - White line (Water reaction)

153
Q

Specific hazard indicating nuclear radiation risk.

A

Radiation - Nuclear sign

154
Q

Reactivity classification indicating that the material may detonate.

A

4 - May detonate

155
Q

Reactivity classification indicating that shock and heat may detonate the material.

A

3 - Shock and heat may detonate

156
Q

Reactivity classification indicating a violent chemical change.

A

2 - Violent chemical change

157
Q

Reactivity classification indicating instability if heated.

A

1 - Unstable if heated

158
Q

Reactivity classification indicating stability.

A

0 - Stable

159
Q

Action steps in the event of a fire: Rescue, Alarm, Contain, Extinguish/Evacuate.

A

Fire hazard actions

160
Q

Steps for operating a fire extinguisher.

A

Pull pin, Aim nozzle, Squeeze trigger, Sweep nozzle

161
Q

Class of combustibles that includes ordinary materials like wood, paper, and cloth.

A

A - Ordinary combustibles

162
Q

Extinguishers used for Class A fires (ordinary combustibles).

A

Pressurized water (A), Dry chemical (ABC)

163
Q

Class of combustibles that includes flammable liquids like grease, gasoline, and paints.

A

B - Flammable liquids

164
Q

Extinguishers used for Class B fires (flammable liquids).

A

Dry chemical, Carbon dioxide (BC), Halon

165
Q

Class of combustibles that includes electrical equipment like motors and switches.

A

C - Electrical equipment

166
Q

Extinguishers used for Class C fires (electrical equipment).

A

Dry chemical, Carbon dioxide, Halon

167
Q

Class of combustibles that includes flammable metals like magnesium and sodium.

A

D - Flammable metals

168
Q

Extinguishers used for Class D fires (flammable metals).

A

Metal X (special dry chemical) or sand

169
Q

Class of combustibles for materials that may result in detonation, which cannot be extinguished.

A

E - Arsenal or materials liable to detonation

170
Q

Class of fire hazard for combustible cooking media, like oils and fats in commercial kitchens.

A

K - Combustible cooking media

171
Q

Extinguisher used for Class K fires (combustible cooking media).

A

Liquid designed to prevent splashing and cool the fire