The laboratory testing cycle encompasses all activities starting from a medical doctor writing a laboratory request up to the time the results are generated and become useful information for the treatment and management of patients.
The phases of laboratory testing include the pre-analytic, analytic, and post-analytic.
The pre-analytic phase of laboratory testing is a crucial part of the process and laboratory professionals have no direct involvement in this process.
Pre-analytic errors, if not spotted, can cause serious problems further down the line.
The analytical phase refers to the situations and actions that take place prior/during the collection, during the processing/storage/transportation of the specimen, quality control, patient preparation, accurate paperwork, data entry.
The analytical phase includes the performance of the tests that have been ordered, which includes maintenance and calibration of laboratory equipment and instruments, testing and performing quality control measures, and training of laboratory personnel performing the test.
The quality laboratory includes two major components: Internal Quality Assurance System (IQAS) and External Quality Assurance System (EQAS).
EQAS is a system for checking performance among clinical laboratories & is facilitated by designated external agencies, with NRL being the DOH-designated EQAS.
Errors may arise during the post-analytical phase due to incorrect calculations, delayed turnaround time for results, results returned to the wrong individual, and results not being reported.
Errors may arise during the analytical phase due to issues with verification and quality control of performance specs, collaboration errors, reagent mistakes, errors stemming from manual pipetting, and interference from unidentified antibodies.
In the EQAS procedure, an unknown sample is sent to a clin lab and results are sent back to the NRL.
Quality laboratory encompasses all activities performed by laboratory personnel to ensure reliability of test results.
IQAS includes day-to-day activities that are undertaken in order to control factors or variables that may affect test results, and regular review & audit of results are done in order to identify weaknesses & consequently perform corrective actions.
The post-analytical phase includes the processes associated with recording and reporting of laboratory results, storage and/or disposal of specimens after testing, and provider and patient notification of test results.
The post-analytical phase is the final stage of the testing process where test results are reviewed by clinicians, results should be promptly released, and it is important for critical results to make critical health decisions for the patients.
External quality control specimens are sent to clinical laboratories from external sources.
Quantitative results in clinical laboratories are the range of expected results.
Internal quality control indicators are commonly used in qualitative testing.
A certificate of performance is issued to the participating clinical laboratory.
Precision in clinical laboratories is the reproducibility of results specific for the machine.
Mathematical errors can occur in clinical laboratories due to clinician errors in preparation and processing.
Qualitative results in clinical laboratories can be either a negative or positive result.
A reference solution that comes with a kit or may be purchased separately can be used to compare the results of specimen to the data provided.
Competency testing in clinical laboratories is a method to evaluate the personnel who perform the laboratory tests, by direct observation, or by introducing mock specimens with known values into the patient load and evaluating the results and documentation after the test is complete.
If the test is not valid, the internal quality control indicator does not develop properly.
Internal quality control specimens are used in clinical laboratories.
Proficiency testing in clinical laboratories is a method to measure the performance of a laboratory externally.
Internal quality control indicators are usually a color indicator that is part of the individual testing kits.
Accuracy in clinical laboratories is how close the result produced for that test is to the real value.
If results of external quality control specimen are not as expected, the kit or reagent cannot be used to test patient samples until the problem has been identified and solved.
Mistakes caused by staff fatigue can also be a problem in clinical laboratories.
Internal quality control indicators in clinical laboratories show that the test process was valid, but they do not provide a test result.
Trouble shooting in clinical laboratories involves checking the expiration of kits, verifying storage of kits, checking the maintenance of instruments, and doing other necessary steps.