Exam 2

which of the followign organizations approve waived tests for home use?

FDA

which of the followign is true about rule 1 2s?

a control will violate the rule approximately once in every 20 acceptable runs

staff

a diverse and multigenerational workforce

which process provides continuous process improvement through the following steps: define the need, measure process to find errors, analyse the data to confirm errors, improve the process to reduce errors, and control the process to prevent future errors?

SIX SIGMA

health hazard

blue diamond

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

required regulation of clinical laboratories is achieved by the:

clinical laboratory improvement amendments of 1988

main purpose of six sigma process management tool is...

continuous improvement methodology to meaasure and eliminate defects in your process

lab scientists and other ealth care workers handling patient or patient specimens are requireed to PPD skin tests for TB every six months

false

sharps injuries are uncommon

false

systems

formal and informal processes and procedures that make the organization function

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

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

information related to hazards associated with chemicals in the workplace must be provided in:

safety data sheets

which of th efollowing factors influence process design?

size and setting of the lab, as well as test priority equipment, test methodology and overall staffing regulatory and accreditation requirements

most appropiate tool to assist you with appropriate lab layout is...

spaghetti diagram

quality assurance testing in the pre-analytical phase includes all of the following:

specimen identification specimen transport specimen collection

an example of a preanalytical error is:

specimen obtained from the wrong patient

how would you define staffing?

staffing is a selection, hiring, training, and retaining of lab professionals

an automated cell counter consistently produces red blood cell readings that are 20% too low. what type of error is this considered?

systematic

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

driver

task-focused and acting - get it done

analytical

task-focused and thinking - get it right

the following are necessary roles in process management team:

team leader team members scribe and timekeeper

strategy

that which communicates the organization's mission

structure

the grouping and relationships of how tasks are divided and coordinated

skills and competencies

the necessary expertise needed to perform tasks in the workplace

OSHA stands for:

the occupational safety and health administration

what does the mode of data set represent?

the value that occurs most frequently

a certificate is issued to a lab...

to enable the entity to conduct moderate or high complexity laboratory testign or both until the entity is determined by survey to be in compliance with the CLIA regulations

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-jenings 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 thsi be considered?

trend

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

universal precautions requires that all blood and body fluids must be handled as if they are infected

true

which of the following should be considered an important requirement when adopting a new POCT method?

uses a small blood sample rapid turnaround time accuracy and precision of results comparible with cenral lab testing

__________ traces the current workflow starting with the customer and working backward to identify value-add and non-value-add ativities at each stage of production.

value stream mapping

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

dispersion

when random error or lack of precision increases

special hazard

white diamond

gen x-ers (1965-1980)

work to live and are independent

instability hazard

yellow diamond

phases of LEAN six sigma's process which can be used for inventory management (QSE#5):

1. sort - keep only necessary items in the workplace and discard unused inventory items 2. set in order - arrange items in a logical order to quickly identify supplies and promote efficient workflow 3. shine - clean the work area so it is neat and tidy and you can find additional inventory supplies 4. standardize - set up standards for a consistently organized workspace and determine needed quotas of supplies as a comparison standard 5. systematize - maintain and review standards and set up efficient inventory procedures to quickly tally supplies

the minimum that should be spent washing hands with soap is:

20 sec

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? thsi model was used to identify a problem, execute a plan, monitor the process, and then act with a solution.

PDCA

which of the quality system essentials requires the establishment of who performs specific funcitons on different computer systems?

QSE#10 information management

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 requires that the laboratory define its legal identity?

QSE#5 organization

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 essentials requires the supervision of "the who does what and when"?

QSE#7 process management

central tendency

a gradual change in the control sample results

shift

a sudden and sustained change in one direction in control sample values

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

how does one calculate the mean of a data set?

add all 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

BSL4

airlock entry, shower exit, special waste disposal

BSL2

associated with human disease and pose moderate hazards to personnel and the environment

which of the followign procedures is classified as highly complex testign but is sometimes performed as POCT?

gram staining

shared values

guiding principles and aspirations shared by employees that work for the organization

all the following are considered high-risk bloodborne pathogens to lab scientists:

hep b hep c human immunodeficiency virus

accuracy describes:

how close a test result is to the true value

style

how managers approach and interact with their employees

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

what is process design?

it is an activity of determining workflow and implementation requirements for a particular process

what is quality control?

it is method control and on-going effort to maintain the integrity of the process and reliability of the outcome

main purpose of LEAN process management tool is...

it is methodology of continuous improvement and elimination of waste in your process

what is workflow?

it is the outline of a series of activities that are necessary to complete a task

which of the following is crucial feature of a substance used as a control?

it should mimic the chemical and physical properties of a typical patient specimen

a combined approach to process management that sustains procedures by standardizing a process of sorting-straightening-shining the workplace environment.

lean six sigma - 5s

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 informaiton

baby boomers (1946-1964)

live to work and are competitive

gen z-ers (linksters) (1995-present)

liver their own way and are ethically diverse

traditionalists (1922-1945)

loyal to company and are dedicated to service

the statistical parameters to measure central tendency include all of the following"

mean median mode

which of the following terms can be defined as the organization's purpose, calling, or reason for existence?

mission

gen y-ers (millenials) (1981-1994)

multitaskers and have a sense of community

BSL3

mycobacterium tuberculosis

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

BSL1

open bench work

a class a fire is:

ordinary combustables

quality assessment programs include:

patient identification specimen procurement specimen transportation and processing procedures

according to quality management system essentials #2 customer focus, laboratory customers are...

patients and clinicians patients only community and regulatory agencies

expressive

people-focused and acting - get appreciated

amiable

people-focused and thinking - get along

according to CLIA general requirements for non-waived testign, 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 definition of a biohazard is:

potentially infectious materials or agents

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

according to CLSI, main stages of the laboratory path of workflow are...

preexamination, examination, and post-examination

effective fire prevention plan should address the following:

preparedness, training, and mitigation and response in case of fire, including drills

preanalytical phase

process involved before the sample is actually tested in the laboratory

analytical phase:

process within the lab itself that involve the actual testing of the specimen

postanalytical phase

processes between completion of the analytical process and receipt and follow-up by the phycisian

first letter "P" in acronym "PASS" for appropriate operation of fire extinguisher stands for?

pull the pin to unlock the fire extinguisher

according to QSE#3 facilities and safety the following safety programs must be implemented in every laboratory except...

radiation safety

flammability hazard

red diamond

one of three quality-control results for an instrument violates the 1 2s rules. what is the proper course of action?

refrain from running patient specimens until resolution of the problem