Volume 36 Number 2 | April 2022

Patient Safety Corner

Georgia Vega, MBA, MLS(ASCP)CM, ASCLS Patient Safety Committee

Georgia Vega“Out of sight, out of mind.” Until recently, that phrase could easily describe laboratorians. As medical laboratory professionals work mainly in the background, a common source of career dissatisfaction is feeling overlooked by our patients and healthcare colleagues. How can we make ourselves more visible? There are opportunities available within our CLIA-regulated responsibilities that we must leverage to step outside of the laboratory where statistics show our expertise is greatly needed.

All phases of testing (i.e., pre-analytic, analytic, and post-analytic) are regulated under Clinical Laboratory Improvement Amendments (CLIA). As a profession, the tendency is to primarily focus on the analytic and post-analytic portion of our responsibilities as these phases fall more closely within our perceived level of designated oversight. In the pre-analytic phase of testing, where 60 to 70 percent of diagnostic errors occur1, we manage to the extent of oversight allowable through laboratory-staffed phlebotomy. With other non-laboratory staff who must perform sample collection outside of the laboratory, we offer a specimen collection manual. But is that enough?

“It is critical that laboratory professionals work collaboratively with other healthcare partners as subject matter experts in the pre-analytic phase of testing.”

In working closely with many nurses and medical assistants throughout my career, the extent of phlebotomy training they expressed they received in their respective programs was minimal. Knowledge of order of draw, sources of interferences that could affect test results, or how the anticoagulants or additives in the tube can negatively impact a test result if poured from one tube to the other, is often not part of their curriculum. Nor is an understanding of the importance of tube inversion after sample collection or why it is needed, or the difference between clotting and hemolysis. At a magnet nursing institution, phlebotomy training conducted by nursing educators in the unit consisted of asking a new hire, “Have you drawn blood before?” and observing a venipuncture with the measure of success being, blood in the tube. Could this lack of training for non-laboratory specimen collectors and the laboratory’s lack of oversight in the units contribute to a vast number of errors occurring in the pre-analytic phase of testing? I would argue yes.

The laboratory’s responsibility to oversee the pre-analytic phase of testing is codified in Title 42, Chapter IV, Subchapter G, Part 493, Subpart K. §493.1240 Condition: Pre-analytic Systems states, “[…] The laboratory must monitor and evaluate the overall quality of the pre-analytic systems and correct identified problems as specified in §493.1249 for each specialty and subspecialty of testing performed.” §493.1249 Standard: Pre-analytic Systems Quality Assessment states, “(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the pre-analytic systems specified at §§ 493.1241 through 493.1242. (b) The pre-analytic systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of pre-analytic systems quality assessment reviews with appropriate staff. (c) The laboratory must document all pre-analytic systems quality assessment activities.” There is no indication that our responsibility for pre-analytic quality stops with non-laboratory specimen collectors.

It is critical that laboratory professionals work collaboratively with other healthcare partners as subject matter experts in the pre-analytic phase of testing. Doing so will allow for more visibility to our profession and a gained appreciation outside of the laboratory as sources of knowledge and support. At the same time, this is an opportunity to positively impact patient care. If leveraged effectively, this can also lead to increased laboratory positions including advancement opportunities due to the need for training program development and oversight.

  1. Cornelia Mrazek, Giuseppe Lippi, Martin H Keppel, Thomas K Felder, Hannes Oberkofler, Elisabeth Haschke-Becher, Janne Cadamuro Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions, Biochem Med (Zagreb) 2020 Jun 15; 30(2): 020502. Published online 2020 Jun 15. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7271754/ Accessed: January 24, 2022.
  2. 42 CFR 493 – Laboratory Requirements, https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-K?toc=1 Accessed: January 23, 2022.

Georgia Vega is Senior Director of Laboratory Services at Legacy Community Health in Houston, Texas. She has 16 years of laboratory experience, both on the bench and leading teams, in reference, hospital, and clinic laboratories.