MOLECULAR DIAGNOSTICS :: MASS SPECTROMETRY


Types and Rates of Error in the 3 Stages of the Laboratory Testing Process Type of Error


Phase of Total Testing Process


Pre-analytical • Inappropriate test request


• Order entry errors • Misidentification of patient • Inappropriate container • Sample collection error and inadequate transport • Inadequate sample/anticoagulant volume ratio • Insufficient sample volume • Sorting and routing errors • Labeling errors


Analytical • Equipment malfunction Post-analytical


• Sample mix-ups/interference • Undetected failure in quality control • Procedure not followed • Failure in reporting


• Erroneous validation of analytical data • Improper data entry


Figure 2. Types and Rates of Errors in the 3 Stages of the Laboratory Testing Process Source: Lippi G Guidi GC . Risk management in the pre-analytical phase of laboratory testing. Clin Chem Lab Med. 2007;45:720–727.


laboratories, which lessens productivity and increases turnaround time for many clinical applications.12


Assay methods are


often lab-developed tests (LDTs) whose development and implementation can be challenging. To establish accurate and re- producible MS-based LDTs, a laboratory requires a significant level of expertise. Consequently, LC-MS/MS has not gained traction in hospital laboratories as much as had been anticipated a decade ago.13


today’s immunoassay systems and can be operated by ordinarily trained technicians. Progress toward such solutions will make the analytical powers of LC-MS/MS useful for clinical medicine and will reduce the barriers of entry, increase scalability, and enable the LC-MS/MS platform to be ac- cessible and implemented in routine clini- cal laboratories.2,12


While it will maximize


When asked to identify the key chal- lenges hospital laboratories are facing, staff- ing (26%) was identified as the top priority.14 The Bureau of Labor Statistics has projected a nationwide increase in demand for medical and clinical laboratory technologist of 13% between 2016 and 2026, while at the same time current vacancy rates remain high, averaging 7.2%.15


Limited access to


this kind of expertise and extensive tech- nical training requirements has hindered further growth and implementation of this platform in the clinical lab.12


Automation of LC-MS/MS in clinical laboratories It’s broadly accepted that advances in automation will be paramount to break through this bottleneck and increase the appeal for LC-MS/MS in routine use.12


The next level of automation has to aim at system solutions with features of practicability that are similar to those of


walk-away time and increase throughput, total automation requires other consid- erations such as a broad test menu, the availability of commercial assay kits, standardization and results harmoniza- tion, and timely technical services.12


Key


specifications of a future plug-and-play LC-MS/MS–based clinical analyzer system should include the following elements:2,12 1. Random access /multichannel mode 2. Handling of standard clinical labora- tory sample tubes 3. Bar code reading of tubes for positive identification – bi-directional interface to local LIMS 4. Complete and closed management of ready-made solvents 5. Ready-to-use and bar code identified internal standards 6. Comprehensive auto-start, auto-tuning, auto-validation, and auto-QC functions 7. Comprehensive control of all subsystems 8. Auto-maintenance feature 9. Flexible equipment acquisition models beyond just capital purchase options


7%–13% Rates 46%–68.2%


10. 24-hour technical support and short turnaround time service will be essential, for smooth operation and to minimize downtime. Such solutions of automation are helpful to increase throughput, avoid sources of gross errors, increase the productivity and reliability of analyses, and reduce hands- on time of skilled technicians.2


Overcom-


ing challenges with staffing, fluctuations in testing volumes, improving turnaround times, and reducing errors and costs are all proven benefits that have fueled the adoption of laboratory automation. The po- tential for error reduction is an important benefit of these types of solutions (Figure 2). Published data suggest that 24% – 30% of laboratory errors influence patient care, while actual or potential patient harm occurs in 3% – 12% of cases.15


18.5%–47% Conclusion


Indeed LC-MS/MS can close substantial gaps in the parameter portfolio of labora- tory medicine by allowing routine analyses on a reference method level of accuracy and by facilitating comprehensive testing panels.2


While LC-MS/MS is making its


way into many clinical laboratories, it is still limited to specialty laboratories and many challenges prevent it from being implemented routinely.12


The ability to


offer LC-MS/MS in a random-access high-volume analyzer will improve both turnaround times, as well as improve sensitivity and specificity of the assays.13 But, going forward, will fully auto- mated IVD platforms become the only way LC-MS/MS testing is implemented in the clinical lab? It’s unlikely that will be the case. In 2019, a small survey of hospital LC-MS laboratory directors were asked whether they would transition all clini- cal mass spectrometry testing to a closed, fully automated Food and Drug Admin- istration (FDA)-approved LC-MS/MS system if one became available — only one respondent would choose replace- ment. 13


More than half said they would


retain their open-access, lab-developed LC-MS/MS tests and continue to develop additional LDTs, as well as using a fully automated closed LC-MS/MS system. In the near future, MS platforms may be differentiated into two categories: one would be the current existing system for esoteric and low-volume laboratory devel- oped tests; the second category would be a basic model sold as a medical device for high-volume and well-defined tests such as vitamin D, drugs of abuse screening and confirmation, and immunosuppres- sant drugs. The latter category may achieve higher-level automation and standardiza-


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