How to Succeed in MS

The prospect of bringing mass spectrometry (MS) to the clinical laboratory is exciting. In my experience, implementing new technology and tests into a lab opens up tremendous opportunities. It is, however, not an easy undertaking and you will need to be aware of many potential pitfalls. Some examples of important things to consider are selecting the right test for the right patient population, justifying the cost, hiring the right personnel, and choosing the best instrument for your needs. All need careful consideration during the justification and preparation phase.

The first step is to choose the right test. Different from other platforms, such as immunoassays, liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems are very specific and can provide definite answers, which is why many patients can benefit from results from MS analysis. Confirmation testing of drugs of abuse and screening for inborn errors of metabolism are good examples; specific compounds are identified or quantified using mass spectrometry to provide definitive answers in drug testing and to elucidate complicated metabolism pathways. LC-MS/MS can also offer high sensitivity when examining testosterone and other steroid hormones. Therefore, the first step is to select well-documented tests that will suit your patient population at your institution.

A financial justification is most likely needed for implementing an MS system. The capital expenses have been a challenge for most institutions as LC-MS/MS systems are expensive. Fortunately, their operation costs are relatively low. The financial justification is usually based on savings from send-out costs. A great place to start is to evaluate the test volume and send-out costs for potential assays to be implemented on LC-MS/MS. If the sample volume is right, the cost per test can be significantly lower than sending them out. Typically, you can use a return on investment (ROI) calculation, as shown below:

Although the savings gained by bringing tests in-house are easy to calculate using charge per test and the test volume, calculating the ROI can be more complicated, primarily because not all benefits are monetary. For example, reduced turnaround time, control over the sample process, and reduced transcription error by processing the samples in-house can have an enormous benefit to patients, but translating these into financial benefit for the institution is difficult. Typically these non-monetary benefits are listed as separate considerations.

In addition to this challenge, personnel needs and training are difficult factors to deal with when starting an MS lab, mainly because most clinical laboratory professionals won’t be familiar with the technique. MS analyses are not as straightforward as those performed using automated clinical chemistry analyzers. In particular, samples need to be processed manually before analysis, and the results need to be reviewed before reporting. This requires someone with extensive knowledge in clinical chemistry, sample preparation, LC, MS and a number of other areas of expertise.

You can broadly group clinical MS laboratory staff into three categories – day-to-day operators (the largest population), troubleshooting personnel (a smaller number) and a few experts. It is not necessary to enforce these categories in the lab and some overlapping will be very helpful for coverage and flexibility. However, the skills and experience should match these expectations. Finding the right people can be difficult, especially when starting a laboratory.

Typically, you can train a good medical technologist to run basic assays on an LC-MS/MS system within a few months. Also, being a member of an LC-MS/MS laboratory can advance staff careers, which proves useful for recruiting talented technologists. Troubleshooters will hopefully emerge and develop within the laboratory through continuous training and personal efforts. Experts provide method development and validation and are responsible for training others in the laboratory. The best “expert” candidates usually have extensive experience, creativity and attention to detail.

Overall, LC-MS/MS has become a powerful platform that has been proven to enhance clinical practice in many areas. It is not an easy undertaking to implement this technology. While it is appealing to bring it in-house, it is important to know that it may not be feasible to do so for all laboratories and sending out samples to a reference laboratory may be a better choice. When done correctly, though, the rewards and benefits far outweigh the costs and efforts. The ultimate goal is to have access to this advanced technology for the betterment of patient care.