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
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Name two critical indicators for the analytical phase element Quality Control Evaluations.
- Number and level of controls is appropriate for complexity2. Control ranges appropriate for each assay
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Name two critical indicators for the analytical phase element Proficiency Testing Results.
- When available, PT performed on all analytes2. Appropriate corrective action taken for all failed PT analytes
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Name two critical indicators for the analytical phase element Comparative Analysis for Multiple Analyte Methodologies/Multiple Locations.
- Comparisons performed for each method at all sites2. Relevant criteria established for result comparison
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Name two critical indicators for the post-analytical phase element Appropriateness and Acceptability of Test Results.
- results within reportable range for the test2. reference ranges appropriate for patient population
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Name two critical indicators for the post-analytical phase element Completeness of Test Reports.
- patient name, laboratory name, test result with units, and normal range included2. results reported for all tests ordered
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Name two critical indicators for the post-analytical phase element Timely Reporting of All Test Results Including STAT Turnaround Time.
- Results reported within established turnaround time2. Critical values reported within established timeframe
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Name two critical indicators for the post-analytical phase element Accuracy and Reliability of Test Reporting Systems.
- Investigation of corrected reports2. Reports sent to appropriate physician/department
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Name two critical indicators of the post-analytical phase element Appropriate Storage and Retrieval of Records of Test Results.
- Reports accessible and may be promptly retrieved
- Records stored for required interval
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Name two critical indicators for the post-analytical phase element Problems in Communicating with Physicians or other Health Care Workers.
- mechanism available for communication of complaints2. effectiveness of corrective action for complaints
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Name two critical indicators for the post-analytical phase element Complaint Investigation and Evaluation and Corrective Actions Initiated.
- Mechanism available for communication of complaints2. Effectiveness of corrective action for complaints
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Name two critical indicators for the post-analytical phase element Compliance with Regulatory Requirements.
- Accreditation requirements met2. Safety requirements met
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Name two critical indicators for the post-analytical phase element User Satisfaction Monitors.
- Effective mechanisms established to monitor physician satisfaction2. Effective mechanisms established to monitor patient satisfaction
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Name two critical indicators for the post-analytical phase element Incident Reports.
- Incident reporting system established2. Follow-up to incidents evaluated for effectiveness
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Name three critical indicators for the post-analytical phase element Review of QA Reports with Staff.
- QA findings are reported to staff periodically2. Operating changes resulting from QA are reported to staff in a timely manner3. Review property/accident reports monthly
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Once a critical element has been identified for each element, what are the three threshold or limits that must be identified?
- the data that needs to be collected2. the time period to be covered3. the limits of acceptability
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What is the WHERE portion of a QA plan?
These are all the sites of a laboratory. These sites may include satellite clinics, draw sites, or stat laboratories.
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HOW can a laboratory achieve its QA plan?
A checklist that is reviewed monthly or quarterly can be used to cover many of the critical indicators. A log book of complaints that can be reviewed. A planned audit of patient charts can also be used to identify critical indicators.
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WHO should perform the Quality Assurance reviews?
The WHO will depend on the size of the laboratory.
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What seven items of information should be included in the documentation of QA activities?
- Date of QA review, complaint or problem2. initials or name of the person conducting the review or investigating a complaint or problem3. scope or method of the review4. analysis of the problem5. written documentation of any corrective action taken6. a description of the effectiveness of the corrective action and date of the follow-up review7. documentation that the QA review has been discussed with the lab staff, director, and manager(s)
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How long should a lab retain QA documents?
2 years
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What is the purpose of laboratory Compliance Plans?
to assist hospitals, health systems, and their agents in devising internal controls that effectively foster adherence to applicable federal and state laws and regulations to program requirements of federal, state, and private health plans.
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What are the seven primary principals and elements of a lab Compliance Plan?
- Written policies, procedures, and standards of conduct that promote the lab’s commitment to compliance.2. A chief compliance officer and compliance committee with overall responsibility for developing, monitoring, updating, and enhancing the program.3. education and training of all employees4. ways that individuals can report suspected compliance violations anonymously5. a system to respond to allegations of illegal or improper activities and take appropriate disciplinary action against employees involved.6. internal monitoring, audits, and other evaluative methods to assess compliance efforts and reduce problems.7. investigation and correction of identified problems, as well as development of policies governing employment or retention of individuals sanctioned for healthcare fraud.
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What codes are important for identification of medical necessity?
ICD-9 codes (soon ICD-10)
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What is one thing the lab can do to assist with monitoring medical necessity?
the lab can develop a method to monitor test utilization over time to ensure that physicians are ordering only medically necessary tests.
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Who is responsible for identification of appropriate ICD-9 codes?
the lab should only use ICD-9 codes obtained from the ordering physician.
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What codes are used to designate diagnostic information?
ICD-9 or ICD-10
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True or False: Laboratories should use past information or computer programs that automatically insert ICD-9 codes without physician information.
False
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True or False: Laboratories should only bill for appropriate automated multi-channel chemistry tests.
True
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True or False: Laboratories should only bill for tests that were both ordered and performed.
True
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True or False: Laboratories are permitted to perform ‘standing orders’.
True, but the lab must monitor their continued validity.
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What is the formula to calculate relative centrifugal force?
RCF = 1.118x 10-5x rx rpm21.118 x 10-5 = constant (determined from angular velocity)r = radius in cmrpm = revolutions per minute (speed)
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What type of instrument is used to determine the accuracy of the speed of a centrifuge?
tachometer
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What organization maintains the national standards for temperature?
National Institute of Standards and Technology (NIST)
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NIST
National Institute of Standards and Technology
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Describe the NIST calibrated thermocouple thermometer.
The thermocouple thermometer is a NIST Standard Reference Material (SRM) constructed from gold versus platinum (Au/Pt), calibrated on the International Temperature Scale. It is supplied with integral lead wires and a protective sheath.
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What are the two methods that can be used for pipet calibration?
gravimetric and volumetric
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How is gravimetric pipet calibration performed?
The weight of water is proportional to the volume dispensed by the pipet. Adjustments are made to the pipet based on the measured weight.
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What does gravimetric pipet calibration verify?
It verifies the accuracy of the amount of water that is dispensed by the pipet.
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What does volumetric pipet calibraion verify?
It verifies the accuracy of the amount of dye pipetted into a specific volume of water, which is then read by a spectrophotometer.
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How is volumetric pipet calibration performed?
A specific amount of dye is pipetting into a known volume of water and read by a spectrophotometer. Adjustments to the pipet are made based on the difference in absorbance readings.
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What is the difference between gravimetric and volumetric calibration of pipets?
Gravimetric calibration looks at the weight of the water as proportional to the volume dispensed by the pipet, while volumetric calibration looks at the difference in absorbance readings to make adjustments.
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Name some examples of temperature-regulated equipment.
heat blocks, water baths, room temperature, refridgerators, and freezers.
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What three systems of measurement are used in the United States?
- English (inches, feet, and yards)2. Metric (decimal system, all in multiples of 10)3. International System of Units (SI) (based on 7 units; meter, kilogram, second, mole, kelvin, ampere, candela)
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In SI units, what is the measurement for length?
International System of Units for length is meter.
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In SI units, what is the measurement for mass?
The International System of Units for mass is kilogram.
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In SI units, what is the measurement for time?
The International System of Units for time is second.
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In SI units, what is the measurement for amount of substance?
The International System of Unit for amount of substance is Mole.
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In SI units, what is the measurement for temperature?
The International System of Units for temperature is Kelvin.
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In SI units, what is the measurement for electric current?
The International System of Units for electric current is Ampere.
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In SI units, what is the measurement for luminous intensity?
The International System of Units of measurement for luminous intensity is candela.
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SI System Prefix for Pico
10-12
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SI System Prefix for Micro
10-6
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SI System Prefix for Nano
10-9
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SI System Prefix for Milli
10-3
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SI System Prefix for Deci
10-1
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SI System Prefix for Deka
101
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SI System Prefix for Kilo
103
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SI System Prefix for Mega
106
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SI System Prefix for Giga
109
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What is the mathematical formula for conversion of temperature from fahrenheit to celsius?
C = 5/9 (F-32)
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Convert 95 degrees Fahrenheit to Celsium.
C = 5/9 (95-32)=5/9 x 63= 35 C
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Convert65 degrees Fahrenheit to Celsium.
C = 5/9 (65-32)= 5/9 x 33= 18.3 C
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What is a Confidence Interval?
A confidence interval is an estimated range of values calculated from the mean and standard deviation. It estimates the statistical probability of values falling above or below the mean value on a normal bell-shaped Gaussian curve. Often expressed as a percentage.
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What does a Confidence Interval estimate?
the statistical probability of values falling above or below the mean value on a normal bell-shaped Guassian curve.
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Given a mean (X) of 9.8 and a standard deviation (SD) of 0.2, calculate the 95% CI for the control.
= X + 2 SD= 9.8 + 2 (0.2)= 9.8 + 0.4= 9.8- 0.4 = 9.4=9.8 + 0.4 = 10.2
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What is the formula for a 68% Confidence Interval?
X + 1 = 68%
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What is the formula for a 95% Confidence Interval?
95% = X + 2 SD
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What is the formula for a 99% Confidence Interval?
99% = X + 3 SD
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What is the coefficient of variation (CV)?
ratio of the standard deviation to the arithmetic mean
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What is the formula for Coefficience of Variation (CV)?
CV = (SD/mean) x 100
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What is the calculated coefficient of variation for the following:mean = 200 SD = 5
CV = (SD/mean) x 100= (5/200) x 100= 2.5%
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What is standard deviation (SD)?
the root mean square deviation of the values from their mean;orthe square root of the variance
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Define a Chain of Custody.
Chain of custody refers to the chronological documentation, and/or paper trail, showing the procurement, custody, control, transfer, analysis, and disposition of the specimen.
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What is the purpose of a chain of custody?
a chain of custody form is required for any specimen used as legal evidence in court.
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Describe Accreditation.
Accreditation is a voluntary process by which a non-governmental agency grants recognition to an organization that has achieved a set of predetermined standards.
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Describe Licensure.
Licensure is a mandatory process by which some states grant permission to an individual or organization to engage in a given occupation.
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Computer Network
collection of computers and other hardware interconnected by communication channels that allow sharing of resources and information.
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Network
collection of computers and other hardware interconnected by communication channels that allow sharing of resources and information.
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LAN
Local Area Network
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Local Area Network
computer network that interconnects computers in a limited area such as a health care facility, using network media.
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HIS
Hospital information system
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Hospital Information System
comprehensive, integrated information system designed to manage the medical, administrative, financial, and legal aspects of a hospital and its service processing.
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LIS
Laboratory Information System
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Laboratory Information System
series of computer programs that process, store, and manage data from all stages of laboratory process
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EMR
Electronic Medical Record
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Electronic Medical Record
computerized medical record created in a health care organization
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intranet
computer network that uses internet technology to share information, operational systems or computing services within an organization
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HTML
HyperText markup Language
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HyperText Markup Language
main markup language for displaying web pages and other information that can be displayed in a web browser.
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What is the main markup language that can be used to display web pages and other information to be displayed in a web browser?
HyperText Markup Language (HTML)
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HTTP
HyperText Transfer Protocol
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HyperText Transfer Protocol
HTTP is an application protocol for distributed, collaborative, hypermedia information systems. it is the foundation of the world wide web.
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CPOE
Computerized Provider Order Entry (CPOE)
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Computerized Provider Order Entry (CPOE)
CPOE is a computerized process for health care providers to electronically enter and order medical procedures and laboratory tests based on a predetermined algorithm.
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CPT
Current Procedural Terminology
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What is the purpose of Current Procedural Terminology (CPT) codes?
The purpose of CPT is to provide a uniform language accurately describing medical, surgical, and diagnostic services.
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Do CPTcodes serve as a type of communication nationwide within the health care industry?
yes
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Name two reason that a CPT code might have a modifier.
- a service or procedure has both a technical and professional component2. a service or procedure was performed by more than one physician and/or in more than one location
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What does a -26 CPT code modifier stand for?
26 - Professional Component
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What does a -59 CPT code modifier stand for?
59 - Distinct Procedural Service
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What does a -91 CPT code modifier stand for?
91 - Repeat Clinical Diagnostic Laboratory Test
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In the interpretation of a Levey-Jennings plot, what does shift refer to?
6 consecutive points on one side of the mean
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In the interpretation of a Levey-Jennings plot, what does trend refer to?
6 consecutive points increasing or decreasing that may cross the mean
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What three types of error are included as sources of variation?
- sample error2. random analytical error3. operatory error
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What are the six sources of variation?
- sample error2. random analytical error3. operatory error4. method or instrument bias5. sample or day-to-day variation within a single patient6. patient (race, sex, age, health status)
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What is a laboratory’s main method for external quality control?
Proficiency Testing
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What does proficiency testing verify?
A laboratory’s accuracy
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Proficiency testing specimens should be testing by whom in the lab?
routine testing personnel during routine testing
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Should proficiency testing samples be tested with patient samples?
yes
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Should aliquotes of proficiency samples be saved?
yes, in the case that a re-assay is necessary
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Define a reference range.
A reference range is a collection of normal values for a constituent of clinical interest.
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OHSA
Occupational Safety and Health Administration
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GHS
The Globally Harmonized System of Classification and Labelling of Chemicals
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Name two examples of common reflex tests?
- positive sickle screen reflexes to Hgb electrophoresis2. positive ANA (antinuclear antibodies - allergies) test reflexes an ANA profile3. positive urinalysis results to a urine culture
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What is the definition of reflex testing?
The test is performed on a patient sample only after a particular analyte is abnormal or outside of a predetermined range.
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CPT
Current Procedural Terminology
What organizations are approved to supply PT materials?
AAB, API, and CAP
Who does one enroll in PT through?
Health and Human Services (HHS) via CMS
If you are found to intentionally send out your PT, what will happen?
The laboratory license will be revoked for one year.
What must all laboratories have in place for improvement as part of their QA plan?
documentation of all performance improvement projects, records for 2 years
PI
Performance Improvement
