1 Quality in the Clinical Lab

Question 1

Name 5 things lab results must be

Answer 1

1. Be valid
2. Be applicable
3. Be timely
4. Be cost efficient
5. Cause no patient harm

Question 2

What does quality in the lab guarantees?

Answer 2

Ensures that the needs and expectation of the users (physicians and nurses) and customers (patients) are met

Question 3

Define the clinical laboratory’s path of workflow

Answer 3

The process that changes a physician’s order in a test result

Question 4

For the pre - analytical phase, what are its 4 processes?

Answer 4

1. Test ordering
2. Specimen collection
3. Specimen transport
4. Specimen receipt and processing

Question 5

For the analytical phase, what are its 3 processes?

Answer 5

1. Test performance
2. Review of test results (delta checks/ auto verification is performed)
3. Interpretation of test result

Question 6

For the post analytical phase, what are its 2 processes?

Answer 6

1. Test result reporting
2. Specimen management

Question 7

From the lowest level to the highest level (upper management), what are the 5 stages of quality?

Answer 7

1. Quality control - Foundation level which everything is based on
2. Quality assurance - involved in plans/ policies/ procedures/ training
3. Quality system - maintains/ improves lab processes to meet goals
4. Quality management - focuses on financial impact
5. Total quality management - goal is customer satisfaction

Question 8

Define delta check

Answer 8

It is a part of the review of test results in analytical. Compares test results to a patient’s previous results to detect errors. Results that are different will be followed up before reporting

Question 9

Define auto verification

Answer 9

Is a part of the review of test results in analytical. Is when lab instruments are interfaced to a computer to check the lab results automatically. The results must fall within defined parameters set by the lab.