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In this time of budget cuts and personnel shortages, every line item and full-time equivalent in our budgets is scrutinized and must be justified. To bring new molecular technologies into our labs, we must be able to present a cost-benefit analysis to our laboratory leaders and administrators demonstrating the positive impact these technologies have on our laboratories, our patients and our bottom line.
This article will highlight a few items to consider when evaluating molecular testing options, and give some practical solutions to help in this process.
Rationale
Why should we bring molecular testing into our labs? It may seem easier to just send our samples to a reference laboratory and let it deal with evaluating and implementing these seemingly complicated tests. However, there are quite a few good reasons for bringing these tests in-house, and it can be done cost effectively, if you do your homework. As with most any test a laboratory brings in-house, implementing molecular assays can enhance the service level the laboratory is able to extend to patients and providers. Performing these tests within your laboratory can decrease turnaround time and, in some instances, reduce complicated billing issues arising when using a third-party laboratory.
Implementing these tests allows your laboratory to retain control of the specimen and ensure the quality of the testing process. This is important for several reasons. First, and probably the most basic, there is no risk of lost or damaged specimen samples due to courier transportation. This also allows the laboratory to monitor all quality control and quality assurance processes.
Performing these tests in-house also allows the laboratory to have ownership of the information and data produced from this testing. Having patients' test information all in one place makes it easier for providers to find the information and use it to make informed decisions about patient care. It also gives the laboratory access to statistical information regarding these tests, which may serve to advance the laboratory's molecular service.
Choosing a Starting Point
Not every test or method works in every lab, and only your lab staff can decide what is right in your unique situation. The best place to start is with your current patient population and specimen volume.
As a cytopathology supervisor, my personal experience with molecular tests began with the samples that had the largest volume in our department-Pap tests. As human papilloma virus (HPV) testing emerged as recommended molecular testing in conjunction with Pap test collection, our laboratory evaluated our ability to cost effectively bring this testing in-house and implemented an HPV test.
Your lab might be affiliated with a busy urology clinic that may have a lot of urine samples requiring testing for recurring bladder cancer. Maybe your lab operates a fine needle aspiration clinic from which you collect breast aspirates suitable for testing Her2/neu status. There may be an oncology clinic down the hall interested in UGT-1A1 testing for their colon cancer patients or evaluating circulating tumor cells (CTC) for patient prognostic testing.
Think outside the box and explore the testing possibilities your laboratory possesses. Think about the patients and providers you serve, and how you could serve them better with the right molecular tests.
Personnel Requirements
After the sample/test selection is complete, the most important item to consider when choosing a molecular testing platform is personnel. As defined by CLIA '88, individuals may only perform high complexity tests authorized by the laboratory director and requiring a degree of skill commensurate with the individual's education, training or experience, and technical abilities. Before selecting any platform, laboratory leaders must ensure the proper personnel are in place, or acquired, to perform the test. Here are some examples of things to consider when selecting testing personnel:
- State licensure: Some states have strict requirements of who can perform molecular testing. Make sure the personnel you would like to perform molecular testing are able to do so under your state's licensure laws and regulations.
- Molecular background: Although it is not a CLIA requirement to have specific molecular training to perform most tests, some molecular background is essential in troubleshooting and validating molecular assays. Molecular pathology certification, offered by the ASCP Board of Registry, is an option for employees to demonstrate competency in this area.Another option is the successful completion of a molecular diagnostics certification program. Many colleges now offer these programs, several of them online, from which employees can gain molecular training.
- Skill: Small reagent volumes for some manual platforms may challenge even the most skilled technologists. Additionally, environmental factors we may sometimes overlook, like small variations in a testing procedure or how a workspace is disinfected, can have a huge effect on the performance of molecular tests. It is important personnel performing these tests have the disposition to work in this type of environment.
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