Podcast
Questions and Answers
What agency approves new test methodologies, instruments, and reagents before they are available for purchase by consumers?
What agency approves new test methodologies, instruments, and reagents before they are available for purchase by consumers?
FDA
How often should biological safety hoods be inspected?
How often should biological safety hoods be inspected?
What is the minimum number of standards required for a standard curve?
What is the minimum number of standards required for a standard curve?
3
Define Osmolal gap
Define Osmolal gap
Signup and view all the answers
What is the maximum magnification using a brightfield microscope?
What is the maximum magnification using a brightfield microscope?
Signup and view all the answers
What is the most accurate pipette for reconstituting control material?
What is the most accurate pipette for reconstituting control material?
Signup and view all the answers
Which unit of measure refers to 10^-3?
Which unit of measure refers to 10^-3?
Signup and view all the answers
What is the calculated cholesterol/HDL ratio given the following results?
Cholesterol 225 mg/dL
HDL 75 mg/dL
What is the calculated cholesterol/HDL ratio given the following results? Cholesterol 225 mg/dL HDL 75 mg/dL
Signup and view all the answers
200 microliters of patient serum is diluted with 800 microliters of saline. What is the final dilution?
200 microliters of patient serum is diluted with 800 microliters of saline. What is the final dilution?
Signup and view all the answers
What is the calculated LDL cholesterol given the following lipid profile results?
Triglycerides 190 mg/dL
Cholesterol 225 mg/dL
HDL 75 mg/dL
What is the calculated LDL cholesterol given the following lipid profile results? Triglycerides 190 mg/dL Cholesterol 225 mg/dL HDL 75 mg/dL
Signup and view all the answers
How is relative centrifugal force calculated?
How is relative centrifugal force calculated?
Signup and view all the answers
A chain of custody is required for all of the following:
A chain of custody is required for all of the following:
Signup and view all the answers
A chain of custody is required for all of the following, EXCEPT:
A chain of custody is required for all of the following, EXCEPT:
Signup and view all the answers
What federal legislation regulates most clinical laboratories?
What federal legislation regulates most clinical laboratories?
Signup and view all the answers
What is the level of complexity of most testing performed in clinical laboratories?
What is the level of complexity of most testing performed in clinical laboratories?
Signup and view all the answers
How often does CLIA require clinical laboratories to have inspections?
How often does CLIA require clinical laboratories to have inspections?
Signup and view all the answers
Which laboratories are NOT required to participate in proficiency testing?
Which laboratories are NOT required to participate in proficiency testing?
Signup and view all the answers
Which proficiency testing (PT) results do not meet the CLIA performance criteria?
Which proficiency testing (PT) results do not meet the CLIA performance criteria?
Signup and view all the answers
Which one of the following is an example of alternate proficiency testing?
Which one of the following is an example of alternate proficiency testing?
Signup and view all the answers
All of the following are pre-analytical errors except which one?
All of the following are pre-analytical errors except which one?
Signup and view all the answers
Solvents that are extremely volatile and produce vapors that can accumulate and ignite should be
Solvents that are extremely volatile and produce vapors that can accumulate and ignite should be
Signup and view all the answers
As Sally was performing an experiment, something splashed into her eye. What should she do immediately?
As Sally was performing an experiment, something splashed into her eye. What should she do immediately?
Signup and view all the answers
Proper ____ _____ is one of the most important ways to prevent the spread of infection and the spread of antibiotic-resistant bacteria.
Proper ____ _____ is one of the most important ways to prevent the spread of infection and the spread of antibiotic-resistant bacteria.
Signup and view all the answers
The term "Standard Precautions" refers to a concept of bloodborne disease control, which requires that all human blood and other potentially infectious materials:
The term "Standard Precautions" refers to a concept of bloodborne disease control, which requires that all human blood and other potentially infectious materials:
Signup and view all the answers
All of the following are pre-analytical errors:
All of the following are pre-analytical errors:
Signup and view all the answers
Which one of the following is the most common analytical error?
Which one of the following is the most common analytical error?
Signup and view all the answers
What is the most common post-analytical error?
What is the most common post-analytical error?
Signup and view all the answers
How often must a procedure be reviewed?
How often must a procedure be reviewed?
Signup and view all the answers
How often must thermometers be checked against the NIST thermometer?
How often must thermometers be checked against the NIST thermometer?
Signup and view all the answers
In which manual are the directions for running quality control for a specific assay kept?
In which manual are the directions for running quality control for a specific assay kept?
Signup and view all the answers
Following equipment maintenance, when is quality control suggested?
Following equipment maintenance, when is quality control suggested?
Signup and view all the answers
What is the most common reason for a control value to be outside of 3SD?
What is the most common reason for a control value to be outside of 3SD?
Signup and view all the answers
If one control is outside the 95% confidence limits, then what is the most appropriate remedial action to take initially?
If one control is outside the 95% confidence limits, then what is the most appropriate remedial action to take initially?
Signup and view all the answers
Where should an unopened container of methanol be stored?
Where should an unopened container of methanol be stored?
Signup and view all the answers
After preventative maintenance by field service, which one of the following is recommended?
After preventative maintenance by field service, which one of the following is recommended?
Signup and view all the answers
According to CLIA, who is responsible for specimen processing, test performance, and reporting test results?
According to CLIA, who is responsible for specimen processing, test performance, and reporting test results?
Signup and view all the answers
Which one of the following is NOT a job duty of the testing personnel?
Which one of the following is NOT a job duty of the testing personnel?
Signup and view all the answers
All of the following are job duties of testing personnel:
All of the following are job duties of testing personnel:
Signup and view all the answers
Which one of the following is not required to be kept in the employee's personnel records?
Which one of the following is not required to be kept in the employee's personnel records?
Signup and view all the answers
All of the following are required to be kept in the employee's personnel records:
All of the following are required to be kept in the employee's personnel records:
Signup and view all the answers
Which one of the following statements concerning CEUs is false?
Which one of the following statements concerning CEUs is false?
Signup and view all the answers
Who is responsible for monitoring trends for corrected reports in the laboratory?
Who is responsible for monitoring trends for corrected reports in the laboratory?
Signup and view all the answers
Tracking and trending customer complaints concerning the laboratory is a responsibility of which area?
Tracking and trending customer complaints concerning the laboratory is a responsibility of which area?
Signup and view all the answers
Which federal required employee competency be evaluated at least semiannually during the first year the individual tests patient specimens. Thereafter, competency assessment must be performed at least annually.
Which federal required employee competency be evaluated at least semiannually during the first year the individual tests patient specimens. Thereafter, competency assessment must be performed at least annually.
Signup and view all the answers
Which federal agency issues regulations to ensure employee safety?
Which federal agency issues regulations to ensure employee safety?
Signup and view all the answers
OSHA Hazard Communication Standard requires original container labels to contain all of the following information EXCEPT which one?
OSHA Hazard Communication Standard requires original container labels to contain all of the following information EXCEPT which one?
Signup and view all the answers
OSHA Hazard Communication Standard requires original container labels to contain all of the following information:
OSHA Hazard Communication Standard requires original container labels to contain all of the following information:
Signup and view all the answers
Which federal agency requires safety training during new employee orientation and annually thereafter?
Which federal agency requires safety training during new employee orientation and annually thereafter?
Signup and view all the answers
Which plan minimizes personnel exposure to hazardous chemicals?
Which plan minimizes personnel exposure to hazardous chemicals?
Signup and view all the answers
Which bloodborne pathogens are of greatest risk to laboratorians?
Which bloodborne pathogens are of greatest risk to laboratorians?
Signup and view all the answers
All of the following are components of the OSHA Tuberculosis plan:
All of the following are components of the OSHA Tuberculosis plan:
Signup and view all the answers
All of the following are components of the OSHA Tuberculosis plan EXCEPT:
All of the following are components of the OSHA Tuberculosis plan EXCEPT:
Signup and view all the answers
When a fire occurs, when should the hospital operator be notified of the fire?
When a fire occurs, when should the hospital operator be notified of the fire?
Signup and view all the answers
Which federal agency regulates disposal of biohazardous waste?
Which federal agency regulates disposal of biohazardous waste?
Signup and view all the answers
Which federal agency regulates facilities that use radioisotopes?
Which federal agency regulates facilities that use radioisotopes?
Signup and view all the answers
Which federal agency regulates the disposal of hazardous chemicals and biohazardous wastes?
Which federal agency regulates the disposal of hazardous chemicals and biohazardous wastes?
Signup and view all the answers
Which labor law requires an employer to provide reasonable accommodations to a wheechair-bound employee?
Which labor law requires an employer to provide reasonable accommodations to a wheechair-bound employee?
Signup and view all the answers
Which federal agency is responsible for enforcing employment discrimination laws?
Which federal agency is responsible for enforcing employment discrimination laws?
Signup and view all the answers
Which federal law defines the minimum wage and overtime compensation?
Which federal law defines the minimum wage and overtime compensation?
Signup and view all the answers
Which agency is responsible for enforcing equal pay for equal work?
Which agency is responsible for enforcing equal pay for equal work?
Signup and view all the answers
Title VII, which prohibits discrimination, is part of which labor law?
Title VII, which prohibits discrimination, is part of which labor law?
Signup and view all the answers
Which federal agency regulates packaging, labeling, and transportation of biological products?
Which federal agency regulates packaging, labeling, and transportation of biological products?
Signup and view all the answers
Which law required the Department of Health and Human Services to establish standards for protected health information?
Which law required the Department of Health and Human Services to establish standards for protected health information?
Signup and view all the answers
What do the etched rings on the top of a pipette mean?
What do the etched rings on the top of a pipette mean?
Signup and view all the answers
What is the accuracy of a volumetric pipette?
What is the accuracy of a volumetric pipette?
Signup and view all the answers
What is the term used to describe a 99.95% purified chemical that can be measured directly referred to as?
What is the term used to describe a 99.95% purified chemical that can be measured directly referred to as?
Signup and view all the answers
What is a solution in which the molecules of solute in the solution are in equilibrium with excess undissolved molecules referred to as?
What is a solution in which the molecules of solute in the solution are in equilibrium with excess undissolved molecules referred to as?
Signup and view all the answers
What is the pH of pure water?
What is the pH of pure water?
Signup and view all the answers
Which statistical term most specifically describes analytical precision?
Which statistical term most specifically describes analytical precision?
Signup and view all the answers
Quality control should be performed and monitored to ensure which one of the following?
Quality control should be performed and monitored to ensure which one of the following?
Signup and view all the answers
What is the term used to describe material with physical and chemical properties closely resembling the test specimen and containing concentrations of the substance being measured?
What is the term used to describe material with physical and chemical properties closely resembling the test specimen and containing concentrations of the substance being measured?
Signup and view all the answers
A procedure has a 2SD variation from a mean value. How many values from a normal population will 2SD include?
A procedure has a 2SD variation from a mean value. How many values from a normal population will 2SD include?
Signup and view all the answers
To produce reliable results, how long should a patient fast before having blood drawn for lipid studies?
To produce reliable results, how long should a patient fast before having blood drawn for lipid studies?
Signup and view all the answers
How is a 10% bleach solution to disinfect the work area made?
How is a 10% bleach solution to disinfect the work area made?
Signup and view all the answers
Reactivity is what color diamond using the National Fire Protection Agency code?
Reactivity is what color diamond using the National Fire Protection Agency code?
Signup and view all the answers
What is a substance that minimizes any change in hydrogen ion concentration?
What is a substance that minimizes any change in hydrogen ion concentration?
Signup and view all the answers
Who are the testing personnel for proficiency samples?
Who are the testing personnel for proficiency samples?
Signup and view all the answers
Which type of specimen provides the fastest turnaround time?
Which type of specimen provides the fastest turnaround time?
Signup and view all the answers
If the mean for BUN is 18.0 and one standard deviation is 0.15, then what is the acceptable range for this control?
If the mean for BUN is 18.0 and one standard deviation is 0.15, then what is the acceptable range for this control?
Signup and view all the answers
If the mean for BUN is 18.0 and one standard deviation is 0.13, then what is the coefficient of variation?
If the mean for BUN is 18.0 and one standard deviation is 0.13, then what is the coefficient of variation?
Signup and view all the answers
The total protein is 7.2 g/dL. The serum protein results are:
Albumin 53.0% 3.8 g/dL
Alpha1 3.6% 0.3 g/dL
Alpha2 11.0% 0.8 g/dL
Beta 17.6% 1.2 g/dL
Gamma 14.8% 1.1 g/dL
What is the A/G ratio?
The total protein is 7.2 g/dL. The serum protein results are: Albumin 53.0% 3.8 g/dL Alpha1 3.6% 0.3 g/dL Alpha2 11.0% 0.8 g/dL Beta 17.6% 1.2 g/dL Gamma 14.8% 1.1 g/dL What is the A/G ratio?
Signup and view all the answers
Flashcards
FDA
FDA
The agency that approves new test methodologies, instruments, and reagents.
Biological safety hood inspection frequency
Biological safety hood inspection frequency
Biological safety hoods should be inspected annually.
Minimum standards for a standard curve
Minimum standards for a standard curve
The minimum number of standards required for a standard curve is 3.
Osmolal gap
Osmolal gap
Signup and view all the flashcards
Maximum magnification of brightfield microscope
Maximum magnification of brightfield microscope
Signup and view all the flashcards
Most accurate pipette for control material
Most accurate pipette for control material
Signup and view all the flashcards
Milli-
Milli-
Signup and view all the flashcards
Cholesterol/HDL ratio calculation
Cholesterol/HDL ratio calculation
Signup and view all the flashcards
Final dilution from serum and saline
Final dilution from serum and saline
Signup and view all the flashcards
LDL cholesterol calculation
LDL cholesterol calculation
Signup and view all the flashcards
Relative centrifugal force formula
Relative centrifugal force formula
Signup and view all the flashcards
Chain of custody
Chain of custody
Signup and view all the flashcards
Federal legislation for clinical labs
Federal legislation for clinical labs
Signup and view all the flashcards
Laboratory inspection frequency by CLIA
Laboratory inspection frequency by CLIA
Signup and view all the flashcards
Waived testing laboratories
Waived testing laboratories
Signup and view all the flashcards
CLIA performance criteria failure
CLIA performance criteria failure
Signup and view all the flashcards
Alternate proficiency testing example
Alternate proficiency testing example
Signup and view all the flashcards
Pre-analytical errors
Pre-analytical errors
Signup and view all the flashcards
Emergency from chemical exposure
Emergency from chemical exposure
Signup and view all the flashcards
Importance of hand washing
Importance of hand washing
Signup and view all the flashcards
Standard Precautions concept
Standard Precautions concept
Signup and view all the flashcards
Most common analytical error
Most common analytical error
Signup and view all the flashcards
Most common post-analytical error
Most common post-analytical error
Signup and view all the flashcards
Preventive maintenance documentation retention
Preventive maintenance documentation retention
Signup and view all the flashcards
Flash point definition
Flash point definition
Signup and view all the flashcards
Combustible and flammable liquids
Combustible and flammable liquids
Signup and view all the flashcards
GLI of lab records
GLI of lab records
Signup and view all the flashcards
Study Notes
FDA Approval
- The FDA approves new test methodologies, instruments, and reagents before sale to consumers.
Biological Safety Hood Inspection
- Biological safety hoods should be inspected annually.
Standard Curve Standards
- A minimum of 3 standards are required for a standard curve.
Osmolal Gap Definition
- Osmolal gap is the difference between measured and calculated osmolality in a patient's blood.
Brightfield Microscope Magnification
- The maximum magnification using a brightfield microscope is 1000X.
Control Material Pipetting
- Glass volumetric pipettes are the most accurate for reconstituting control materials.
Metric Prefix (milli)
- Milli- represents 10⁻³.
Cholesterol/HDL Ratio Calculation
- Given cholesterol of 225 mg/dL and HDL of 75 mg/dL, the ratio is 3.0.
Serum Dilution Calculation
- 200 µL serum diluted with 800 µL saline results in a 1:5 final dilution.
LDL Cholesterol Calculation
- To calculate LDL, use the formula: Total cholesterol - HDL - (Triglycerides/5).
- For given values, LDL is approximately 112 mg/dL.
Relative Centrifugal Force Calculation
- Relative centrifugal force (RCF) is calculated using: 1.118 x 10⁻⁵ x r x rpm².
Chain of Custody Requirements
- A chain of custody is required for legal blood alcohol, pre-employment drug screens, and paternity testing.
Chain of Custody Exclusion
- A chain of custody is not required for fetal fibronectin.
CLIA Regulation
- Clinical Laboratory Improvement Amendments (CLIA) regulate most clinical laboratories.
Laboratory Testing Complexity
- Most clinical laboratory tests are moderately complex.
CLIA Inspection Frequency
- CLIA requires inspections every 2 years.
Exempt Laboratories from Proficiency Testing
- Laboratories performing waived tests are not subject to proficiency testing requirements.
Failed Proficiency Testing
- Laboratories failing the same analyte in 2 consecutive proficiency tests do not meet CLIA criteria.
Alternate Proficiency Testing
- Split samples sent to another facility using the same test method is an example of alternate proficiency testing.
Pre-analytical Errors
- Ordering a lab test under the wrong patient number, patient misidentification, or mislabeling an add-on test are pre-analytical errors.
- Transcription error during manual result entry is a pre-analytical error.
Solvent Storage
- Extremely volatile solvents (like methanol) should be stored in explosion-proof refrigerators.
Eye Injury Response
- Immediately flush the eye with eyewash for 15 minutes after a chemical splash.
Infection Prevention
- Proper hand washing is crucial for preventing infection and antibiotic-resistant bacteria spread.
Standard Precautions
- Treat all human blood and other potentially infectious materials as if known to be infectious for HIV or HBV or other bloodborne pathogens.
Analytical Errors
- Not checking specimen integrity is a common analytical error.
Post-analytical Errors
- Clerical errors are the most common post-analytical errors.
Procedure Review Frequency
- Procedures must be reviewed annually.
Thermometer Calibration Frequency
- Thermometers must be checked against the NIST thermometer annually.
Quality Control Procedure Manual Location
- Quality control procedures for specific assays are outlined in the operating procedure manual.
Quality Control After Maintenance
- Quality control is suggested after preventative maintenance by field service.
Causes of Control Values Outside 3SD
- Random error is the most common reason for a control value being outside of 3SD.
Remedial Action for Out-of-Range Controls
- Repeat the control test initially.
Methanol Storage
- Unopened methanol containers should be stored in a flammable safety cabinet.
Post-Maintenance Verification
- Verification of QC results after preventative maintenance is recommended following field service.
CLIA Personnel Responsibility
- Testing personnel are responsible for specimen processing, test performance, and reporting test results.
Non-Testing Personnel Duties
- Interpretation of highly complex testing is not a job duty of testing personnel.
Required Employee Records
- Job competency training checklists, remedial action documentation, and annual performance appraisals are required for employees records.
- Continuing education documents are typically not required for employee personnel records.
CEU Mandates
- CEUs are not mandated by the College of American Pathologists.
Complaint Monitoring
- Quality assurance is responsible for monitoring complaints and trends in corrected test results.
OSHA Safety Training
- OSHA mandates safety training during new employee orientation and annually.
Chemical Hygiene Plan
- A chemical hygiene plan minimizes personnel exposure to hazardous chemicals.
Greatest Bloodborne Pathogen Risk
- Hepatitis B and HIV pose the highest risk to laboratory personnel.
OSHA Tuberculosis Plan Components
- All employees with patient contact must be fit tested, PPD skin tests for all employees, positive PPD employees must have annual chest x-rays are components of the OSHA Tuberculosis plan
OSHA Tuberculosis Plan Exclusion
- Employees are not exempt from respirator fit tests in the OSHA Tuberculosis plan.
Fire Notification
- Notify the hospital operator after pulling the fire alarm.
Biohazardous Waste Disposal Regulation
- The Environmental Protection Agency (EPA) regulates the disposal of biohazardous waste.
Radioisotope Facility Regulation
- The Nuclear Regulatory Commission (NRC) regulates facilities using radioisotopes.
Hazardous Materials Disposal Regulation
- The EPA is responsible for regulating the disposal of hazardous chemicals and biohazardous waste.
Disability Accommodation
- The Americans with Disabilities Act requires employers to provide reasonable accommodations for employees with disabilities.
Employment Discrimination Enforcement
- The Equal Employment Opportunity Commission (EEOC) enforces employment discrimination laws.
Minimum Wage and Overtime Compensation
- The Fair Labor Standards Act defines minimum wage and overtime compensation.
Equal Pay Enforcement
- The Fair Labor Standards Act (FLSA) enforces equal pay for equal work.
Title VII
- The Civil Rights Act addresses discrimination.
Biological Product Packaging Regulation
- The Department of Transportation (DOT) regulates the packaging, labeling, and transportation of biological products.
Health Information Standards
- The Health Insurance Portability and Accountability Act (HIPAA) established standards for protected health information.
Pipette Etching
- Etched rings on pipettes indicate the last drop must be blown out manually.
Volumetric Pipette Accuracy
- Volumetric pipettes have an accuracy of 1:1000.
Primary Standard
- A 99.95% purified chemical, measurable directly, is a primary standard.
Saturated Solution
- A saturated solution is one where solute and undissolved solute are in equilibrium.
Pure Water pH
- Pure water has a pH of 7.0.
Analytical Precision Term
- The coefficient of variation most specifically describes analytical precision.
Quality Control Purpose
- Quality control ensures reliability in test results.
Control Material Characteristics
- Control material is similar to the test specimen and has known concentrations of the measured substance.
Statistical Range of Values (2SD)
- 95.5% of values from a normal distribution are captured within 2SD of the mean.
Patient Fasting
- Patients should fast for 12-16 hours before blood being drawn for lipid studies.
Bleach Solution Preparation
- A 10% bleach solution is made by adding 100 mL bleach to 900 mL water.
Reactivity Diamond Color
- Reactivity is indicated in yellow using the National Fire Protection Agency (NFPA) code.
Buffer Definition
- A buffer minimizes changes in hydrogen ion concentration.
Proficiency Testing Personnel
- Any personnel performing the test are responsible for proficiency testing samples.
Fastest Turnaround Specimen
- Whole blood specimens typically have the fastest turnaround time.
BUN Acceptable Range
- For a BUN mean of 18.0 and standard deviation of 0.15, 95% range = 17.7 to 18.3 mg/dL.
Coefficient of Variation Calculation
- For a BUN mean of 18.0 and standard deviation of 0.13, the coefficient of variation is 0.72%.
A/G Ratio Calculation
- To calculate the A/G ratio, divide albumin by the sum of globulins. For given values, the A/G ratio is approximately 1.1
Temperature Conversion Formulas
- Fahrenheit to Celsius: °C = 5/9(°F - 32)
- Celsius to Fahrenheit: °F = 9/5(°C + 32)
Beer's Law Formula
- A = 2 - log(%T)
Centrifugation Speed Measurement
- A tachometer measures the speed (RPM) of centrifugation.
Pipette Blowout Instruction
- A blowout pipet requires expelling the last drop of liquid.
Pipettes included in transfer pipettes
- Transfer pipettes include volumetric, Ostwald-Folin, Pasteur, and automatic macropipets or micropipets
Labware Recalibration
- Class A labware does not require recalibration by the lab.
Thermometer Calibration Frequency (CLSI)
- CLSI recommends NIST-certified thermometer calibrations annually.
Reflex Tests Description
- Reflexed tests are procedures where additional tests are automatically initiated by an initial test.
QA Components
- Quality control is a physical activity to monitor analytical processes during the analytical phase only.
QA Process
- Quality assurance involves monitoring and evaluation of laboratory testing for quality improvement.
Maintenance Record Keeping
- A laboratory must maintain complete documentation on scheduled and unscheduled maintenance, service records, and calibrations for 2 years.
Personnel Competency Evaluation
- Personnel competency for testing must be evaluated at least semiannually during the first year of patient specimen testing, then annually thereafter.
CMS Complaint Evaluation
- CMS complaints are investigated, and site-specific complaints are evaluated locally.
Flash Point
- The flash point is the lowest temperature at which a liquid gives off enough vapor to form an ignitable mixture with air.
Combustible Liquid Definition
- Combustible liquids have flash points at or exceeding 100°F (37.8°C).
Flammable Liquid Definition
- Flammable liquids have flash points below 100°F (37.8°C).
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
Test your knowledge on essential laboratory techniques and calculations, including FDA approval processes, standard curve requirements, and various biochemical calculations. This quiz covers critical aspects of laboratory safety and measurement accuracy, crucial for students and professionals in the field.
