QUALITY CONTROL QUESTIONS AND ANSWERS
Monitor and evaluate outgoing/overall quality of the total testing process and the
effectiveness of its policies and procedures? - Answers - Quality Assurance
Identifies and corrects problems and ensure the accurate, reliable, and prompt reporting
of tests results. Also, it ensures the adequacy and competency of staff. - Answers -
Quality Assurance
Ensures accuracy and reliability of EACH PATIENT SAMPLE measurement..
It also achieve positive patient outcomes by identifying and controlling errors? - Answers
- Quality Control
What are the possible errors that can be identified by quality control? - Answers - - Pre-
Analitical
-Analytical
-Post-Analitical
Wat are analytical errors? - Answers - * instrument malfunction
* lack of maintenance on instrument
* inadequate environmental control such as:
-electrical supply
-water supply
-temperature
* inadequate operator training
* incorrect calibration
* used of compromised reagent
What are the Pre-Analytical errors? - Answers - - errors that happen before the analysis
of the sample. E.g.:
* Sample taken from wrong patient
* wrong sample analyzed
* wrong test ordered or performed
* patient sample not properly collected
* patient sample not properly preserved
* incorrect patient instruction or preparation
What are Post-Analytical errors? - Answers - * Wrong result reported or charted
* Computer Error
-manual entry
-instrument interface to LIS
- Transmission to HIS
*Incorrect interpretation of tests results provided to clinician
*Incorrect patient normal ranges
, "Golden Rule of Medical Laboratory Technology" - Answers - " No result is better than
the wrong result "
What are the goals of Quality Control? - Answers - -100% Error Detection!
-0% False Rejection
-Identify where the error comes from
-Correct error
What does CLIA 88 Stands for? - Answers - Clinical Laboratory Improvement
Amendments of 1988
In what year was CLIA effective? - Answers - in 1994
Under CLIA: - Answers - -Health and human services regulations apply to almost all
laboratory tests of human specimens.
-Based on test complexity and risk factors
- CLIA certification, inspection and sanctions
-Proficiency testing, quality control, personnel
CLIA Regulations? - Answers - is the requirements for moderately or highly complex
quantitative tests.
Eg:
* 2 level of control material per day
* Normal, or abnormal is at clinician deception point
* Test in same manner as Patient Sample
* Detect Error from environmental or operator factor
* Verify/Establish a new test system's method performance.
Is the process of testing and adjusting a test system to provide a KNOWN
RELATIONSHIP between the measurement response and the value of the substance
being measured? - Answers - Calibration
Is a material that monitors daily stability of the test system by comparing the result with
an expected range of values? - Answers - Control
Commercial control serum pools? - Answers - Lyophilized serum
Stabilized low-temperature (-70 C) liquid serum
Negative for hepatitis and HIV required by FDA
Urine and CSF controls for those procedures
Monitor and evaluate outgoing/overall quality of the total testing process and the
effectiveness of its policies and procedures? - Answers - Quality Assurance
Identifies and corrects problems and ensure the accurate, reliable, and prompt reporting
of tests results. Also, it ensures the adequacy and competency of staff. - Answers -
Quality Assurance
Ensures accuracy and reliability of EACH PATIENT SAMPLE measurement..
It also achieve positive patient outcomes by identifying and controlling errors? - Answers
- Quality Control
What are the possible errors that can be identified by quality control? - Answers - - Pre-
Analitical
-Analytical
-Post-Analitical
Wat are analytical errors? - Answers - * instrument malfunction
* lack of maintenance on instrument
* inadequate environmental control such as:
-electrical supply
-water supply
-temperature
* inadequate operator training
* incorrect calibration
* used of compromised reagent
What are the Pre-Analytical errors? - Answers - - errors that happen before the analysis
of the sample. E.g.:
* Sample taken from wrong patient
* wrong sample analyzed
* wrong test ordered or performed
* patient sample not properly collected
* patient sample not properly preserved
* incorrect patient instruction or preparation
What are Post-Analytical errors? - Answers - * Wrong result reported or charted
* Computer Error
-manual entry
-instrument interface to LIS
- Transmission to HIS
*Incorrect interpretation of tests results provided to clinician
*Incorrect patient normal ranges
, "Golden Rule of Medical Laboratory Technology" - Answers - " No result is better than
the wrong result "
What are the goals of Quality Control? - Answers - -100% Error Detection!
-0% False Rejection
-Identify where the error comes from
-Correct error
What does CLIA 88 Stands for? - Answers - Clinical Laboratory Improvement
Amendments of 1988
In what year was CLIA effective? - Answers - in 1994
Under CLIA: - Answers - -Health and human services regulations apply to almost all
laboratory tests of human specimens.
-Based on test complexity and risk factors
- CLIA certification, inspection and sanctions
-Proficiency testing, quality control, personnel
CLIA Regulations? - Answers - is the requirements for moderately or highly complex
quantitative tests.
Eg:
* 2 level of control material per day
* Normal, or abnormal is at clinician deception point
* Test in same manner as Patient Sample
* Detect Error from environmental or operator factor
* Verify/Establish a new test system's method performance.
Is the process of testing and adjusting a test system to provide a KNOWN
RELATIONSHIP between the measurement response and the value of the substance
being measured? - Answers - Calibration
Is a material that monitors daily stability of the test system by comparing the result with
an expected range of values? - Answers - Control
Commercial control serum pools? - Answers - Lyophilized serum
Stabilized low-temperature (-70 C) liquid serum
Negative for hepatitis and HIV required by FDA
Urine and CSF controls for those procedures
