Laboratory Management Test 2 Review Weeks 7-11
Given the mean of 30 and the standard deviation of 13, what is the coefficient of variation? Answer to the nearest tenth.
(SD/Mean) x 100 = 43.3
Controls should be different in composition from the patient specimen.
FALSE
Laboratory scientists and other health care workers handling patients or patient specimens are required to PPD skin testes for TB every six months.
FALSE
Sharps injuries are uncommon.
FALSE
Which of the following organizations approve waived tests for home use?
FDA
Match the workforce generation with the valued characteristic it brings to the workplace. Question multitaskers and have a sense of community live to work and are competitive live their own way and are ethnically diverse work to live and are independent loyal to company and are dedicated to service
Gen y-ers (millenials) (1981-1994) Baby boomers (1946-1964) gen z-ers (1995- present) Gen x-ers (1965- 1980 Traditionalists (1922-1945)
Match NFPA colors to descriptions of hazards: Question Blue Diamond Red Diamond Yellow Diamond White (clear, no color) Diamond
Health hazard Flammability hazard Instability hazard Special hazard
Accuracy describes:
How close a test result is to the true value
Which of the following explains the primary use of Levey-Jennings charts?
Identification of outliers, trends, and shifts in data that may indicate a malfunction or other problem
Process Definition Document is created with the main purpose of...
To outline goals and objectives of your process, as well as key stakeholders and process owner
A Levey-Jennings chart is created to analyze a set of data. The last consecutive eight data points gradually move downward away from the mean. What type of aberration would this be considered?
Trend
Match the term with the correct description. Question a gradual change in the control sample results a sudden and sustained change in one direction in control sample values when random error or lack of precision increases
Trend Shift Dispersion
POCT is also known as near-patient testing.
True
The cost per test of point-of-care testing is often more than volume routine lab testing, however, POCT reduces overall patient costs.
True
________________ traces the current workflow starting with the customer and working backward to identify value-add and non-value-add activities at each stage of production.
Value stream mapping
One of three quality-control results for an instrument violates the 12s rule. What is the proper course of action?
Refrain from running patient specimens until resolution of the problem
Which of the following should NOT be considered an important requirement when adopting a new POCT method?
Requires significant technical skill
The following is a Levey-Jennings chart measuring a single control.What Westgard Rule is violated in this chart? There are two points above the +2SD
Rule 2v2s
Information related to hazards associated with chemicals in the workplace must be provided in:
SDS - safety data sheet
Which process provides continuous process improvement through the following steps: define the need, measure process to find errors, analyze the data to confirm errors, improve the process to reduce errors, and control the process to prevent future errors?
SIX SIGMA
An example of a preanalytical error is:
Specimen obtained from the wrong patient
What are the rules, as stated by CLIA, for the number and frequency of control tests that a laboratory should run on a qualitative assay?
A test of one positive and one negative control must be run at least once per day
Which of the following factors influence Process Design?
ALL of the above -size and setting of the laboratory, as well as test priority -equipment, test methodology and overall staffing -regulatory and accreditation requirements
What is Quality Management System?
ALL of the above: resources, processes, procedures and organizational structure required for quality management it is a culture QMS is all including summary of your laboratory quality activities
How does one calculate the mean of a data set?
Add at the values together and divide the sum by the number of values
Sources of variance or error include:
Age of a specimen, Procedural factors, Physical activity level of a patient
Quality assessment programs include:
All of the above. a. patient identification. b. specimen procurement. c. specimen transportation and processing procedures.
Universal Precautions requires that all blood and body fluids must be handled as if they are infected.
TRUE
The following are necessary roles in Process Management Team except...
Technical specialist (the necessary roles are Team leader, Team member, scribe and timekeeper
Which of the following sets of data would be bimodal?
The one with two numbers that appear most frequently ex. 2, 2, 5, 6, 9, 9, 10, 12, 15, 17, 19
On the SDS, what is covered in the Transport information?
classification of chemical for shipping and transportation
Main purpose of Six Sigma process management tool is...
continuous improvement methodology to measure and eliminate defects in your process
Match the personality type with its corresponding description. Question People-focused and acting (get appreciated) Task-focused and thinking (get it right) People-focused and thinking (get along) Task-focused and acting (get it done)
expressive analytical amiable driver
The following are useful and necessary steps during the investigation of Nonconforming Event Management EXCEPT...
review of hiring practices to ensure we do not hire personnel that make mistakes
Match each of the elements of McKinsey's 7S model of organizational design with its corresponding description. Question Guiding principles and aspirations shared by employees that work for the organization. A diverse and multigenerational workforce. How managers approach and interact with their employees. Formal and informal processes and procedures that make the organization function. That which communicates the organization's mission. The necessary expertise needed to perform tasks in the workplace. The grouping and relationships of how tasks are divided and coordinated.
shared values staff style systems strategy skills and competencies structure
Most appropriate tool to assist you with appropriate laboratory layout is...
spaghetti diagram
Quality Assurance testing in the pre-analytical phase includes all of the following, EXCEPT:
specimen testing (this is the analytical phase)
How would you define Staffing?
staffing is a selection, hiring, training, and retaining of laboratory professionals
The statistical parameters to measure central tendency include all of the following, EXCEPT:
standard deviation (central tendency is mean, median, and mode)
An automated cell counter consistently produces red blood cell readings that are 20% too low. What type of error is this considered?
systematic
The following is a Levey-Jennings chart. Which of the following is the best conclusion based on the circled data?
the data violate the westgard rule of 10x so the recent run must be rejected
What does the mode of a data set represent?
the value that occurs most frequently
A certificate of registration is issued to a laboratory.........
to enable the entity to conduct moderate of high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations
A facility that does not admit TB patients but may perform initial assessment and diagnosis would be categorized as ___________.
very low risk
Over-the-counter tests kits are in which CLIA category?
waived
Required regulation of clinical laboratories is achieved by the:
Clinical Laboratory Improvement Amendments of 1988
Which of the following statements correctly applies to the 8/80 workweek rule? (Choose all that apply)
-Can only work 8 hours in a day (any time over 8 hours in a day will be paid as overtime) -Limits the number of hours per day but NOT the number of days in a row -Only allowed in critical healthcare setting
Match the appropriate biosafety level (BSL) with the appropriate associated description. Question open bench work Associated with human disease & pose moderate hazards to personnel & the environment Airlock entry, shower exit, special waste disposal Mycobacterium tuberculosis
BSL 1 BSL2 BSL4 BSL3
Place the following phases of LEAN Six Sigma's process which can be used for inventory management (QSE#5).
1. SORT 2. SET IN ORDER 3. SHINE 4. STANDARDIZE 5. SYSTEMATIZE
Given the following data set, calculate the mean. Answer to the nearest tenth. {11, 25, 21, 22, 11, 16}
17.7
The minimum time that should be spent washing hands with soap is:
20 seconds
You are provided the following set of data: 20, 21, 28, 42, 43, 43, 50 Which value represents the median of this data set?
42
Given the following CLIA scoring sheet, to which category would the scored method be assigned? adds up to be 13
> 12 is high complexity
Which of the following is true about Rule 12s?
A control will violate the rule approximately once in every 20 acceptable runs
This figure demonstrates the universal _______________ symbol.
Biohazard
All of the following are considered high-risk bloodborne pathogens to laboratory scientists, EXCEPT:
CMV (high-risk bloodborne pathogens are HIV, HEP b, and Hep C
Never use a CO2 extinguisher on this type of fire.
Class A fire
Process Design must fulfill the following except:
It must reflect preferences of laboratory personnel (It SHOULD be cost effective, needs to reflect organizational needs and budgets, must ensure that your process produces quality results)
Which process ensures continuous process improvement through waste reduction while respecting the workplace staff?
LEAN
A combined approach to process management that sustains procedures by standardizing a process of sorting -straightening-shining (cleaning) the workplace environment.
Lean Six Sigma- 5S
OSHA stands for:
Occupational Safety and Health Administration
Which of the following process management tools was developed by Walter Shewhart in the 1920s to simplify and guide workers at the Western Electric company on practicing continuous improvement objectives? This model was used to identify a problem, execute a plan, monitor the process, and then act with a solution.
PDCA (PDSA)
According to QSE#2 Customer Focus, laboratory customers are...
Patients, clinicians, community and regulatory agencies
The definition of a biohazard is:
Potentially infectious materials or agents
Match the phase of testing with its corresponding description. Question Processes involved before the sample is actually tested in the laboratory Processes within the lab itself that involve the actual testing of the specimen Processes between completion of the analytic process and receipt and follow-up by the physician.
Pre analytical analytical post analytical
According to the CLSI, main stages of the Laboratory Path of Workflow are...
Pre-examination, examination, and Post-examination
Effective Fire Prevention plan should address the following:
Preparedness, training, and mitigation and response in case of fire, including drills
First letter - letter "P" - in acronym "PASS" for appropriate operation of fire extinguisher stands for?
Pull the pin
Which of the Quality System Essentials requires that the laboratory define its legal identity?
QSE #1 Organization
Which of the Quality System Essentials will address temperature and humidity of your laboratory environment?
QSE #3 Facilities and Safety
Which of the Quality System Essentials requires initial as well as on-going employee competency assessments?
QSE #4 Personnel
Which of the Quality System Essentials will address supplies storage and management?
QSE #5 Purchasing and Inventory
Which of the Quality System Essentials requires the implementation of calibration and maintenance programs?
QSE #6 Equipment
Which of the Quality System Essentials requires the supervision of "the who does what and when"?
QSE #7 Process managment
Which of the Quality System Essentials requires the establishment of who performs specific functions on different computer systems?
QSE# 9 Information Management
According to QSE#3 Facilities and Safety the following safety programs must be implemented in every laboratory except...
Radiation Safety
Root Cause Analysis focuses on...
a systematic approach to identifying causal factors that resulted in the NCE. focuses on systems and process, not on the individual performance, objective is to identify potential improvements in the processes or systems that would decrease the likelihood of such events in the future.
What is Workflow?
an outline of a series of activities that are necessary to complete a task
Which of the following procedures is classified as highly complex testing but is sometimes performed as POCT?
gram staining
Main purpose of LEAN process management tool is...
it is a methodology of continuous improvement and elimination of waste in your process
What is Process Design?
it is an activity of determining workflow and implementation requirements for a particular process
The following plot is a Levey-Jennings chart. Which of the following is true about the data point noted by the arrow?
it is an outlier
What is Quality Control?
it is method control and on-going effort to maintain the integrity of the process and reliability of the outcome
Which of the following is a crucial feature of a substance used as a control?
it should mimic the chemical and physical properties of a typical patient specimen
The FDA is evaluating a method which would require maintenance by individuals with special knowledge, skills, and abilities. This procedure would be classified as:
level cannot be based solely on this information
A laboratory technician measures the concentration of serum glucose in a sample ten times and obtains the following results: 32, 84, 84, 86, 87, 87, 88, 89, 89 Which of the following is most impacted by the presence of the outlier value?
mean
Which of the following terms can be defined as the organization's purpose, calling, or reason for existence?
mission
What is a major disadvantage of just reporting the mean, median, and mode of a data set?
none of these values tell how widely dispersed the data are around it
A Class A fire is:
ordinary combustibles
According to the CLIA general requirements for non-waived testing, what additional policies or procedures must be in place in addition to following manufacturer's directions?
policies and procedures for pre-analytical, analytical, and post-analytical testing associated with the testing
The normal range for a given test is 1.5 - 2.0. Your control tests results are as follows: 2.2, 2.2, 2.2, and 2.2. This is an example of what parameter?
precision
