Last Friday was a typical Friday – random odd issues arose which needed immediate responses. Both of the technologists who are trained and competent to perform a very low volume, but rapidly needed specialized test were out of the laboratory, one on vacation and one sick. Of course, a sample with a request for that test came in to the lab. I gloved and gowned and went to perform the necessary extraction and analysis. As I was working, a technologist in the main lab stopped by and asked me if I were competent to perform the test. I responded with a blank stare – probably not quite an appropriate response. However, if I personally have developed a test from scratch and put it through all the extensive, required CLIA validations and evaluations, if I wrote the procedure and trained all the techs who perform the test, am I competent to perform it? And that question is entirely aside from the question of whether I have been shown to be competent via the regulatory requirements. Who signs off on me?
Standard laboratory practices, as well as the regulatory agencies laboratories operate under, make certain that we perform tests correctly in order to ensure accurate and reproducible results. Patient care relies heavily on lab test results, and so getting the correct answer to the physician in a timely manner is paramount in our work. To ensure correct performance of a test, each person performing the test must be shown to be “competent” to perform the test. Competency assessment is a big part of laboratory medicine. There are multiple different methods for determining competency, such as direct observation, blind testing of known samples, computer based training, written exams, etc. Regulatory agencies suggest more than one method of determining competency be used for each competent employee to ensure accurate results. During initial training of an employee, direct observation is generally used, perhaps in conjunction with blind testing of known specimens.
In routine lab work and routine point of care testing there usually is someone available to determine whether a person is competent to perform a test. For example a nurse performing a glucose on a glucometer may be signed off as competent by her “super-user” or nurse-educator, who was signed off as competent by the laboratory technologist in charge of point of care testing, who may have been signed off by a company representative initially. Later the lab technologist may be signed off by his or her laboratory colleagues, who in turn are signed off by him or her. There is essentially always someone competent to sign off the competency of the next person.
But what about laboratory developed tests (LDTs)? This is like asking who trains the trainer. Can I now not perform this test until one of the techs I trained directly observes me run it and signs off that I’m competent?
Okay, all you folks developing LDTs. I’m interested to hear your take on this question.