In recent years, the concept of quality monitoring for laboratory testing has broadened beyond quality control focused on the analytic phase, to encompass the entire spectrum of the testing process from the physician’s order through the final report. The impetus for this has been the realization that “up to 70% of all errors made in laboratory testing occurs during the pre-analytic phase, most of which arise from problems in patient preparation, sample collection, transportation, and preparation for analysis and storage.” 1
It is somewhat surprising to think that we are just now recognizing the importance of quality monitoring in the pre-analytic phase. However, unlike the analytic and post analytic phases, the processes of the pre-analytic phase often involve personnel that are not under the direct supervision of the laboratory, making it more challenging to control.
In house, laboratories must check the orders received for accuracy and completeness. One thing that is often overlooked is the importance of providing correct instructions to the patient for the self-collection of specimens. Patients may need to fast, observe specific guidelines such as the clean catch urine procedure, or collect samples over a 24 hour period prior to testing. Not following the correct instructions for sample collection has a direct impact on the quality of the samples received.
Next, the specimen labeling system and patient identification procedures must be in place and followed. It is imperative that labs utilize at least two unique identifiers for the correct identification of patients and their specimens.
For phlebotomy related tasks, it is recommended that labs assess the competencyof all drawing staff, whether they are part of the laboratory or not. This includes nurses, respiratory therapists, medical assistants, anyone who draws blood or collects other specimens for laboratory testing. It is a good idea to track all rejected specimens, making sure to specify the reason for the rejection. For example, an increase in the number of samples rejected for insufficient quantity; for hemolysis; wrong vacutainer utilized, and so on, may point to a phlebotomy training issue that needs to be addressed.
Equally important is specimen handling and transport. A specimen collected properly is not going to be of use if it is not handled and transported correctly. Are specimens centrifuged and aliquoted within the specified time? How about refrigeration or freezer requirements if testing cannot be performed immediately?
Specimens received from outside collection sites pose a different risk for laboratories. Upon receipt of specimens, utilize a checklist to ensure that all the above requirements have been met prior to accepting the specimen. A specimen rejection policy is a must.
Your Quality Assessment plan should include evaluations of all phases of the testing process to ensure that errors detected have been addressed effectively.
(1) Quality Indicators To Detect Pre-Analytical Errors In Laboratory Testing http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3428256/