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Quality Management System Questions & Answers
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Quality Management System Questions & Answers What are quality system essentials? -areas in which clinical labs are inspected, accredited and/or licensed -aline with ISO15189, international standards that specifies the requirements and competence in a lab -provide universal guidelines that are ...

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  • December 29, 2024
  • 6
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • quality management system questions answers
  • what are the 12 quality system essentials 1 docu
  • what does quality assurance look at monitoring

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  • Laboratory management
  • Laboratory management

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Quality Management System Questions
& Answers
What are quality system essentials? - answer -areas in which clinical labs are
inspected, accredited and/or licensed
-aline with ISO15189, international standards that specifies the requirements and
competence in a lab
-provide universal guidelines that are applicable to any size lab in any dispute

What are the 12 quality system essentials? - answer 1. Documents and records
2. Organization
3. Personnel
4. Equipment
5. Purchasing and inventory
6. Process management
7. Information management
8. Non-conforming event management
9. Assessments-internal and external
10. Continual improvement
11. Customer focus
12. Facilities and safety

What does quality assurance look at ? - answer -monitoring, improving or eliminating
errors
-the best people to make those observations and have conservation about change are
the people involved in the processes everyday

Risk management identifies ? - answer -areas within clinical, financial, and
environmental settings that can have an effect on intended outcomes

To evaluate when problems occur and identify strategies for improvement, steps
outlined in ISO 15189 are similar to what steps used in troubleshooting out of control
events? - answer 1. Recognize a problem in the process
2. Identify potential causes
3. Determine if a recent change made an impact
4. Figure out a plan to improve the process
5. Implement the plan
6. Review effectiveness of the change by evaluating through review or audit
7. Adjust the plan based on the results of the review

Within each assessment for change the lab must be able to do what? - answer -
identify, measure, and control the cost of quality in each of the paths of workflow

, How do current trends in evidence-based lab medicine and collaborative patient care
help to resolve issues? - answer -identifying where testing is appropriate, how the
test results impact treatment and what benefits can be found
-ie: many screenings test such as Point of care testing are being introduced as a way to
decrease diagnosis time, use healthcare resources more effectively, reduce lab costs
and help speed up initial treatment

PICOT - answer P: identify the patient population/test
I: identify the point of interest or change. Often an idea based on discovery that a
process/test isn't working as well as it could in relation to patient care
C: choose a patient group or test that you want to compare to
O: what is the outcome of the question you are asking.
T: timeframe that you will use before analyzing your results

What is another strategy used to assess quality improvements? - answer -using
SMART goal setting
-involves formulating a plan, identifying how that plan will impact a needed change, and
then setting out to achieve that goal
-used for goal setting for safety compliance

SMART stands for goals which are? - answer S: specific-what exactly is the concern
needing reviewed/fixed
M: measurable-how can we assess the improvement that is made?
A: attainable-what type of time frame can we use to realistically meet our goals
R: relevant-how important is the goal for organization or is it a single event?
T: timely-is there a realistic timeframe to complete the goal?

Documents and reports includes? - answer -labs must have documents in place for
staff: policies, procedures and processes outlining how to do tasks relevant to their
scope of practice
-these are instructions or manuals that lab professional are expected to follow to ensure
procedures are done correctly

Criteria to meet these standards for documents and records includes? - answer -
periodic review of documents for correctness
-any revisions if present, should be made by designated staff member
-document formatting should look the same
-step-by-step process must be in place for writing new procedures
-new procedures are appropriately review and authorized by senior staff
-old versions of methods should be kept for specific timeframe

Criteria to meet organizational standards includes? - answer -quality manual is in
place within the organization
-a specialist in the area of quality (quality manager) works to maintain and improve
quality within the organization

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