Exam 2 Flashcards
Which of the Quality System Essentials requires initial as well as on-going employee competency assessments?
QSE#4 Personnel
Root Cause Analysis focuses on…
Systems and processes, not on the individual performance Usually the payment is determined based on each service provided
Systematic approach to identifying casual factors that resulted in the NCE
Identification of potential improvements in processes or systems that would decrease the likelihood of such events in the future or at least, reduce their severity
All of the Above (*)
What is Quality Control?
It is method control and on-going effort to maintain the integrity of the process AND reliability of the outcome
Place the following phases of LEAN Six Sigma’s process which can be used for inventory management (QSE#5).
4.
STANDARDIZE - set up standards for a consistently organized workspace and determine needed quotas of supplies as a comparison standard.
1.
SORT - keep only the necessary items in the workplace and discard unused inventory items.
5.
SYSTEMATIZE - maintain and review standards and set up efficient inventory procedures to quickly tally supplies.
3.
SHINE - clean the work area so it is neat and tidy and you can find additional inventory supplies.
2.
SET IN ORDER - arrange items in a logical order to quickly identify supplies and promote efficient workflow.
Required regulation of clinical laboratories is achieved by the:
Clinical Laboratory Improvement Amendments of 1988
Match the phase of testing with its corresponding description.
-
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.
C.
Processes involved before the sample is actually tested in the laboratory
A.
Processes within the lab itself that involve the actual testing of the specimen
B.
Processes between completion of the analytic process and receipt and follow-up by the physician.
A.
Analytical phase
B.
Postanalytical phase
C.
Preanalytical phase
An example of a preanalytical error is:
Specimen obtained from the wrong patient
What is Quality Management System?
Resources, processes, procedures and organizational structure required for quality management
It is a CULTURE
QMS is all including summary of your laboratory quality activities
All of the above (*)
According to QSE#2 Customer Focus, laboratory customers are…
Patients and Clinicians
Patients only
Community and Regulatory agencies
All of the Above (*)
Which of the Quality System Essentials requires that the laboratory define its legal identity?
QSE#5 Organization
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 makes mistakes
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
According to QSE#3 Facilities and Safety the following safety programs must be implemented in every laboratory except…
Radiation Safety
Quality assessment programs include:
Patient identification
Specimen procurement
Specimen transportation and processing procedures
All of the above (*)
Effective Fire Prevention plan should address the following:
Preparedness, training, and mitigation and response in case of fire, including drills
Which of the Quality System Essentials requires the supervision of “the who does what and when”?
QSE#7 Process Management
Which of the Quality System Essentials requires the establishment of who performs specific functions on different computer systems?
QSE#10 Information Management
According to the CLSI, main stages of the Laboratory Path of Workflow are…
Preexamination, examination, and post-examination
Which of the Quality System Essentials will address temperature and humidity of your laboratory environment?
QSE#3 Facilities and Safety
An automated cell counter consistently produces red blood cell readings that are 20% too low. What type of error is this considered?
systematic
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.
The following is a Levey-Jennings chart.
The data violate the Westgard Rule of 10x; so the recent run must be rejected.
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
One of three quality-control results for an instrument violates the 1 2s rule. What is the proper course of action?
Refrain from running patient specimens until resolution of the problem.
Controls should be different in composition from the patient specimen.
False
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
Which of the following is true about Rule 1 2s?
A violation of this rule should result in rejection of the recent runs.
Sources of variance or error include:
Age of a specimen
Procedural factors
Physical activity level of a patient
All of the above (*)
The statistical parameters to measure central tendency include all of the following, EXCEPT:
standard deviation
Accuracy describes
How close a test result is to the true value
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.
Match the term with the correct description.
IV.
a gradual change in the control sample results
I.
a sudden and sustained change in one direction in control sample values
V.
when random error or lack of precision increases
I.
shift
II.
trend or drift
III.
mode
IV.
central tendency
V.
dispersion
Which of the following sets of data would be bimodal?
2, 2, 5, 6, 9, 9, 10, 12, 15, 17, 19
What does the mode of a data set represent?
The values that occurs that most frequent
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
You are provided the following set of data:
Which value represents the median of this data set?
42
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.
Quality Assurance testing in the pre-analytical phase includes all of the following, EXCEPT:
specimen testing
How does one calculate the mean of a data set?
Add all the values together and divide the sum by the number of values
Which of the following organizations approve waived tests for home use?
FDA
Which of the following procedures is classified as highly complex testing but is sometimes performed as POCT?
gram staining
POCT is also known as near-patient testing.
True
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 FDA is evaluating a method which would require maintenance by individuals with special knowledge, skills, and abilities. This procedure would be classified as:
high complexity
A certificate of registration is issued to a laboratory………
to enable the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations.
The cost per test of point-of-care testing is often more than volume routine lab testing, however, POCT reduces overall patient costs.
True
Over-the-counter tests kits are in which CLIA category?
Waived
Which of the following should NOT be considered an important requirement when adopting a new POCT method?
Requires significant technical skill
Process Design must fulfill the following except:
It must ensure that your process produces quality results
Which of the following factors influence Process Design?
Size and setting of the laboratory, as well as test priority
Equipment, test methodology and overall staffing
Regulatory and accreditation requirements
All of the Above *
Match the personality type with its corresponding description.
D.
People-focused and acting (get appreciated)
B.
Task-focused and thinking (get it right)
A.
People-focused and thinking (get along)
C.
Task-focused and acting (get it done)
A.
amiable
B.
analytical
C.
driver
D.
expressive
Match each of the elements of McKinsey’s 7S model of organizational design with its corresponding description.
B.
Guiding principles and aspirations shared by employees that work for the organization.
C.
A diverse and multigenerational workforce.
F.
How managers approach and interact with their employees.
G.
Formal and informal processes and procedures that make the organization function.
D.
That which communicates the organization’s mission.
B.
The necessary expertise needed to perform tasks in the workplace.
E.
The grouping and relationships of how tasks are divided and coordinated.
A.
shared values
B.
skills and competencies
C.
staff
D.
strategy
E.
structure
F.
style
G.
systems
How would you define Staffing?`
Staffing is a selection, hiring, training, and retaining of laboratory professionals
What is Process Design?
It is an activity of determining workflow and implementation requirements for a particular process
What is Workflow?
It is an outline of a series of activities that are necessary to complete a task
Main purpose of Six Sigma process management tool is…
Continuous Improvement methodology to measure and eliminate defects in your process
Which of the following terms can be defined as the organization’s purpose, calling, or reason for existence?
mission
________________ 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
Which process ensures continuous process improvement through waste reduction while respecting the workplace staff?
LEAN
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
Most appropriate tool to assist you with appropriate laboratory layout is…
Spaghetti diagram
Match the workforce generation with the valued characteristic it brings to the workplace.
D.
multitaskers and have a sense of community
B.
live to work and are competitive
E.
live their own way and are ethnically diverse
C.
work to live and are independent
A.
loyal to company and are dedicated to service
A.
traditionalists (1922-1945)
B.
baby boomers (1946-1964)
C.
gen x-ers (1965-1980)
D.
gen y-ers (millenials) (1981-1994)
E.
gen z-ers (linksters) (1995-present)
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
Which of the following statements correctly applies to the 8/80 workweek rule?
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 settings
Main purpose of LEAN process management tool is…
It is a methodology of continuous improvement and elimination of waste in your process
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
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
The following are necessary roles in Process Management Team except…
technical specialist
A Class A fire is:
Ordinary combustibles
The minimum time that should be spent washing hands with soap is:
20 seconds
Universal Precautions requires that all blood and body fluids must be handled as if they are infected
true
On the SDS, what is covered in the Transport information?
classification of chemical for shipping and transportation
The definition of a biohazard is:
Potentially infectious materials or agents
OSHA stands for:
The Occupational Safety and Health Administration
Sharps injuries are uncommon
false
All of the following are considered high-risk bloodborne pathogens to laboratory scientists, EXCEPT:
Cytomegallovirus
Information related to hazards associated with chemicals in the workplace must be provided in:
Safety Data Sheets
Match the appropriate biosafety level (BSL) with the appropriate associated description.
A.
open bench work
B.
Associated with human disease & pose moderate hazards to personnel & the environment
D.
Airlock entry, shower exit, special waste disposal
C.
Mycobacterium tuberculosis
A.
BSL 1
B.
BSL 2
C.
BSL 3
D.
BSL 4
First letter - letter “P” - in acronym “PASS” for appropriate operation of fire extinguisher stands for?
Pull the pin to unlock the fire extinguisher
A facility that does not admit TB patients but may perform initial assessment and diagnosis would be categorized as ___________.
very low risk
Never use a CO2 extinguisher on this type of fire.
Class A fire
Laboratory scientists and other health care workers handling patients or patient specimens are required to PPD skin testes for TB every six
months.
false
Blue Diamond (A)
Red Diamond (B)
Yellow Diamond (C)
White Diamond (D)
A. Health hazard
B. Flammable
C. Instability
D. Special
Coefficient of Variation (CV)
s/x *100%
Preanalytical phase
includes tasks involved before the sample is actually tested in the laboratory (physician orders and their implementation, patient preparations and specimen collection, specimen identification, lab accessioning, etc)
Analytical phase
includes processes within the lab itself that involved the actual testing of the specimen (preparation of the specimen for testing, testing the specimen, performance and interpretation of quality, control on reagents and instrumentation)
Postanalytical phase
includes processes between completion of the analytic process and receipt and follow-up by the physician (reporting of results, receipt and review of results by physician, interpretation and action taken based on results, specimen and results storage)
Latent errors
errors that have occurred as a result of another issue in the lab such as not having sufficient staff to process samples in an accurate and timely manner
Active errors
failing to identify a patient before phlebotomy, missing blood vessels during phlebotomy, errors with collection tubes, errors with transportation system, etc
Controls
in order to determine if there is non-random error in the analytic measurement of patient specimens, surrogate specimens are used to stimulate clinical samples from patients. a minimum of 20 data points are needed to ensure validity and controls are usually run once a day or per shift for at least one month
Dispersion measures
range and standard deviation, acceptable intervals for lab controls are set at +/- 2SD
Precision
indicated by a tight group of values above and below the mean
Imprecision
indicated by a wider distribution of values above and below the mean
Shift
a set of values that consistently stay above or below the mean, without a tendency to increase or decrease, for at least 6 consecutive days
Trend
a set of values that gradually increase or decrease and continue in this pattern for at least 6 consecutive days
1 2S multirule
1 control value exceeds the mean +/- 2SD. this rule is often used as a “warning” rule and should trigger careful inspection of control data
1 3S multirule
1 control value exceeds the mean +/- 3SD
2 2S multirule
2 consecutive control values are on the same side of the mean and exceed the mean +2SD or -2SD
4 1S multirule
4 consecutive control values are on the same side of the mean and exceed +1SD or -1SD (shift)
R 4S multirule
1 control value exceeds the mean +2SD and the next control value exceeds -2SD within the run
10X mutirule
10 consecutive control values are on the same side of the mean
Compliance
a requirement to meet an organizational, federal or professional standard in order to maintain standing with the standards organizing body
Organizations that require compliance
CMS, OSHA, FDA, TJC, CAP, COLA, AABB
Quality management system (QMS)
a system of resources, processes, procedures, and organizational structures required for quality management
Quality assurance (QA)
describes a set of systematic measures that seek to ensure customer satisfaction and instill confidence in the product or services available
Quality improvement
implementation of deliberate changes in the process or processes to improve the reliability of achieving results
QSE 1-Organization
legal identity, functional work divisions to optimize workflow, personnel roles, organizational structures
QSE 2- Customer focus
External customers might be patients, healthcare practitioners, other departments, regulatory agencies or insurance payers. Internal customers might be laboratory personnel, support services and administration
QSE 3- Facilities and safety
all laboratory leaders are responsible for providing safe work environment and all laboratorians are responsible for using safe practices
QSE 5- Purchasing and inventory
Inventory system: the kanban system is a simple workflow management technique that can assist with managing inventory, lean 6 method (sort, set in order, shine, standardize and systematize)
Laboratory safety programs
biosafety, chemical hygiene, hazardous waste management, fire prevention, emergency management, occupational health, radiation safety (may not need if lab doesn’t have a blood bank irridiator or similar)
QSE 4- Personnel
lab leadership needs to work with HR to establish: job qualifications and job descriptions, orientation and onboarding, and management of personnel training.
Once onboarding and training are completed, employee competency is to be assessed.
Results reporting
the lab must have a policy for reporting all normal, abnormal and critical results
Waived testing
an easily-performed, simple test with a low risk of erroneous or inaccurate results and poses no reasonable risk of harm to the patient, as long as the test is performed correctly
Nonwaived testing
all other laboratory testing that is not waived or PPM is sufficiently complex
Moderate complexity test score
less than or equal to 12
High complexity test score
more than 12
Personnel requirements in moderate and high complexity labs
lab director, technical consultant or (for high complexity only ->supervisor), clinical consultant and testing personnel
Certificate of waiver
issued to a laboratory to perform only waived tests
Certificate for provider-perfomed microscopy (PPM)
issued to a lab in which a physician, mid-level practitioner or dentist performers tests other than microscopy. also permits waived test
Certificate of registration
issued to a laboratory that enables the entity to conduct moderate or high complexity testing or both until the entity is determined by survey to be in compliance with CLIA regulations
Certificate of Compliance
issued to a lab after an inspection that finds the lab to be in compliance with all applicable CLIA requirements
Certificate of accreditation
issued to a lab on the basis of the lab’s accreditation by an accreditation organization approved by HCFA
Bloodborne pathogens that pose greatest risk in lab
Hepatitis B, Hepatitis C, HIV
BSL 1
this standard is used while working with infectious agents not known to cause disease in healthy humans
BSL 2
this standard is used while handling infectious agents of moderate potential hazard to personnel. required when processing specimens of blood or body fluids
BSL 3
this standard is used while handling infectious agents of serious or potentially lethal disease via inhalation such as tuberculosis
Class A fire
involve common combustibles such as wood, paper, cloth, rubber trash and plastic. Extinguisher type: water, foam, dry powder, wet chemical
Class B fires
involve flammable liquids, solvents, oil, gasoline, paints, lacquers, and other oil based products. Extinguisher type: foam, dry powder, CO2
Class C fires
Flammable gasses such as butane and methane. Extinguisher type: dry powder
Class D fires
flammable metals such as lithium and potassium. Extinguisher type: dry powder
Class F fires
deep fat dryers, extinguisher: wet chemical
Electrical fires
computers and generators, extinguisher: dry powder, CO2
