Quality Control/Quality Assurance Flashcards
Vaccination for which of the following shall be made available to all employees who have occupational exposure unless the employee has been previously vaccinated, has tested immune, or has medical contraindictions?
a. EBV
b. HBV
c. HIV
d. TB
b. HBV
Personal protective equipment includes all of the following except:
a. disposable lab coat
b. face mask
c. powder-free gloves
d. self-sheathing needles
d. self-sheathing needles
Prior to disposal, contaminated needs should be:
a. bent, broken, and recapped
b. placed in biohazard bags
c. put in rigid puncture proof containers
d. rinsed in a 10% bleach solution
c. put in a rigid puncture proof containers
Mandatory safety training programs should:
a. be provided at initial assignment to tasks where risk of exposure exists
b. be updated annually
c. include instruction of recognition and control of hazards
All of the below:
a. be provided at initial assignment to tasks where risk of exposure exists
b. be updated annually
c. include instruction of recognition and control of hazards
The symptoms of an allergic reaction to latex include:
a. itchy eyes
b. nasal congestion
c. skin irritation
All of the below:
a. itchy eyes
b. nasal congestion
c. skin irritation
Material safety data sheets:
a. are only required for acutely toxic substances
b. are only required for carcinogens, mutagens, and teratogens
c. provide information on exposure to blood-borne pathogens
d. should be kept on file and readily accessible
d. should be kept on file and readily accessible
Pressurized glass cylinders should be:
a. capped when not in use
b. properly secured
c. stored in well-ventilated areas
All of the above:
a. capped when not in use
b. properly secured
c. stored in well-ventilated areas
Experiment and work surfaces can be decontaminated with:
a. 5% formalin
b. 10% household bleach solution
c. 3:1 methanol:acetic acid
d. 0.4% potassium chloride
b. 10% household bleach solution
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Describe Random Error
due to chance and exists in all measurements.
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Describe systematic error
systematic error influences values consistently in one direction
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describe active error
active error occurs at the interface between a laboratorian and the patient samples
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describe latent errors
latent errors are related to the organization or design of a laboratory.
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This type of error is due to chance and can exist in all measurements.
random error
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This type of error influences values consistently in one direction.
systemic error
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This type of error occurs at the interface between a laboratorian and the patient sample.
active error
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This type of error is related to the organization or design of a laboratory.
Latent Error
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Name six sources of variation (factors that affect the measurement of an analyte):
- sample error
- random analytical error
- method or instrument bias (analytical systemic error)
- operator error
- sample (day-to-day variation within a single patient)
- patient (patient variation - race, sex, age, health status)
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Using Westgard Rules, when would use a run as a warning and why?
1(2S) - accept the run; use as a warning when one control results exceeds 2 SD
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Name Four Common Types of Error.
Random Error exists in all measurements and is due to chance.
Systematic error influences values consistently in one direction.
Active error occurs at the interface between a laboratorian and the patient samples.
Latent errors are related to the organization or design of a laboratory.
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Prime Costs
= direct labor + direct materials
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conversion costs
= direct labor + section overhead
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full production costs
= direct labor + direct materials + section overhead
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Ready to Serve Costs
= section overhead + collection and reporting + general laboratory overhead
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Fully Loaded Costs
= prime costs + ready to serve costs
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Describe Direct Costs.
those costs directly assigned to the production of a product, and in the case of a laboratory, the product is a billable test result. Includes consumables and supplies required to perform the test, technical labor related to performing the test and QC related to the test, and apportioned and depreciation equipment costs.
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Describe Indirect Costs
those costs not directly involved with the production of a billable test.
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Describe some of the items included in indirect costs.
costs to acquire specimens and bill for tests,major component is personnel costs,personnel time of those not performing the tests (ie. supervisor, phlebotomists, secretaries), office supplies,billing costs,courier service
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Describe Variable Costs
those costs which change with production volume
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Describe Fixed Costs
those costs that do not change with production volume
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Describe some of the items included in Fixed Costs
lease on equipment,building costs (rent, utilities),technologists needed for coverage regardless of work level,administrative overhead (client services, sales, marketing),management related supplies
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Describe three items included in administrative overhead.
client services, sales, and marketing
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Describe Prime Costs.
director labor and direct material costs which are necessary to produce a billable result.
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Describe Conversion Costs.
those costs necessary to produce a billable result without considering cost of materials.
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What 6 items must be included as part of a laboratory QC program according to federal regulations (CLIA ‘88)?
- follow manufacturer’s instructions
- have a procedure manual describing processes for testing
- perform calibration procedures once every 6 months.
- perform control procedures using at least 2 levels of controls for each day of testing.
- document remedial action
- maintain QC records for 2 years.
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What are two of the most common plots that can be used to visually keep tract of changes in test performance over time?
Levey-Jennings and Cusum plots.
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What set of rules can be used to assist in making determinations on whether an assay should be discarded and/or re-run?
Westgard Rules
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Describe a Levey-Jennings Plot.
plot of control results on the y-axis versus time on the x-axis
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What three characteristics are monitored by a Levey-Jennings plot?
- dispersion (increased frequency of both high and low numbers)
- trend (progressive drift of reported values from a prior mean)
- shift (an abrupt change from the established mean)
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Describe a trend, which can be monitored using a Levey-Jennings plot.
a trend is a progressive drift of reported values from a prior mean
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Describe dispersion in terms of a Levey-Jennings plot.
Dispersion - increased frequency of both high and low numbers
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Describe shift in terms of a Levey-Jennings plot.
Shift - an abrupt change from the established mean
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Describe a Cusum plot.
The expected (or assigned) value is subtracted from the actual value each da of measurement and this difference is summed together over time. When control data are randomly scattered about their expected mean value, the cusum will wanter above and below zero, yeilding a horizontal line. When a systemic error is present, the cusum value will steadily increase above or below zero.
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What plot is useful to distinguish systematic error?
Cusum plot
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How can a cusum plot be used to determine systematic error?
When control data are randomly scattered about their expected mean value, the cusum will wander above and below zero. When systematic error is present, the cusum value will steadily increase above or below zero.
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Westgard Rules are also referred to as …
multirule QC
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Westgard rules are used to decide:a. if there is systematic errorb. if there is random errorc. if the run is in-control or out-of-controld. if the QC for a run passed
c. if the run is in-control or out-of-control
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If only a single criterion or single set of control limits is used for an analytical run, name one QC procedure that can be used.
A single-rule Levey-Jennings char with control limits set as either mean plus or minus 2 standard devisions (2s) or the mean plus or minus 3s.
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What QC procedure can be used when there are 2 to 4 control measurements per run?
Westgard Rules
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Describe the control rule: 1(3s)
A run is rejected when a single control measurement exceeds the mean plus or minus 3s control limit.
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True or False: Under CLIA ‘88, not all laboratories are required to implement a quality assurance program to monitor and evaluate the overall quality of lab services.
False
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Describe a Quality Assessment program.
Used to monitor and evaluate the overall quality of laboratory services.
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What are the three main purposes for having a quality assessment program?
- assess and improve the reliability and efficiency of the laboratory.
- ensure the highest possible quality of service is provided
- comply with regulatory requirements.
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True or False: A Quality Assessment Program does not have to address pre-analytical phases of laboratory operation.
False; a QA program must include all phases of laboratory operations including pre-analytical, analytical, and post-analytical.
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True or False: A laboratory must have written policies and procedures dealing with their quality assurance program.
True
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Name the five major goals associated with a quality assessment program.
- ensure policies and procedures are effective and comply with lab laws and regulations
.2. ensure accurate, reliable, and efficient performance of tests and test reporting. - improve overall quality
- ensure a safe environment for patients and staff.
- meet the physician’s need for rendering a diagnosis and treatment of patients
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Define “Critical indicators”.
processes or events that reveal how well the laboratory is functioning
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Where in CLIA ‘88 can you find information describing specific areas of the laboratory that must be monitored by critical indicators?
CLIA ‘88, Subpart M
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What 8 categories should always have critical indicators?
- appropriate utilization of services
- competency of personnel
- observed or reported incidents
- proficiency testing
- quality control
- Safety
- test management and performance
- user satisfaction
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What members of the laboratory should discuss the quality assurance reviews?
lab staff, lab director, and lab management
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The scope of a Quality Assurance procedures should address what aspects of the plan?
Who, What, Where, When, Why and How
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The HOW question addresses what portion of a Quality Assurance plan?
The method that will be used to collect the data to evaluate the critical indicator threshold or expectations.
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Name some examples of methods used to address the critical indicators of a Quality Assurance plan.
chart audits, laboratory test log reviews, corrective, remedial action log reviews, QC record reviews.
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Describe what elements are in a Quality Assurance plan.
Elements are the policies and procedures associated with each phase of testing.
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What represents the WHAT of a QA plan?
elements (policies and procedures associated with each phase of testing) are used to determine the critical indicators.
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What is an element?
the policies and procedures associated with each phase of testing
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What factor plays a role in determining the number of elements and critical indicators that will be reviewed as part of a lab’s QA program?
The size and type of the laboratory.
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Give a few examples of elements in the pre-analytical phase.
- patient preparation
- specimen collection
- specimen labeling and accessioning
- specimen preservation and storage
- test requisitions
- relevance of test requests
- specimen rejection criteria and actions initiated
- confirmation of oral requests
- evaluation and verification of employee competence, knowledge, and skills
- safety
- procedure updates and reviews
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Name two critical indicators for the pre-analytical phase element Patient Preparation.
- nonfasting - lipid profile2. written instructions
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Name two critical indicators for the pre-analytical phase element Specimen Collection.
- unlabeled tubes2. hemolyzed specimens
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Name two critical indicators for the pre-analytical phase element Specimen Labeling and Accessioning.
- Mislabeled specimens2. Tracking system for referred specimens
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Name two critical indicators for the pre-analytical phase element Specimen Preservation, Transport, and Storage.
- preservatives for 24-hour urines2. storage instructions for specimens
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Name two critical indicators for the pre-analytical phase element Test Requisitions.
- Completeness of requisition forms2. Supplemental information provided when required (ex. PAP smears)
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Name two critical indicators for the pre-analytical phase element Relevance of Test Requests.
- Request consistent with diagnosis2. Age and gender appropriateness
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Name two critical indicators for the pre-analytical phase element Specimen Rejection Criteria and Actions Initiated.
- Specimen integrity acceptable2. Proper Patient preparation
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Name two critical indicators for the pre-analytical phase element Confirmation of Oral Requests.
- Oral request followed by a written within 30 days2. Written request consistent with oral request
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Name two critical indicators for the pre-analytical phase element Evaluation and Verification of Employee competence, Knowledge, and Skills.
- Competency assessment program that covers all disciplines2. Effective remedial training provided for unsatisfactory competencies
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Name two critical indicators for the pre-analytical phase element Safety.
- Employee training is up-to-date2. Safety Data Sheets (MSDS) are complete and up-to-date
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Name two critical indicators of the pre-analytical phase element Procedure Updates and Reviews.
- Annual review has been performed
- All necessary revisions have been completed
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Name two critical indicators of the analytical phase element Instrument Monitoring.
- preventative maintenance is consistent with manufacturer’s recommendations2. function checks performed according to schedule
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Name two critical indicators for the analytical phase element Calibration and Calibration Verification Activities.
- Calibration and/or calibration verification performed according to manufacturer’s recommendation2. Calibration when indicated based on quality control data