Urine GCMS

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afdoc18

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I have heard varying things about the feasibility and reimbursement of purchasing your own GcMS machine for the office. Have also heard some stuff about a company out of Tennessee that sets up the lab for you and runs it? Anyone able to shed some light on this? I'm in a two MD and two NP practice where we do about 50 urines a week....although that number will be increasing....

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I have often considered the same thing, but cannot fathom how one might implement this successfully from a private practice perspective. From the research I conducted, it was cheaper and easier to find a suitable lab - willing to negotiate and/or will let you specify certain testing batteries and/or certain detection limits. While I am sure any company offering to set-up a “lab” in-office can make quite a sales-pitch, there are many things which would make it quite time-consuming as well as prohibitively expensive. My main concerns would be the following:

1) To start, GC/MS instrumentation is not cheap, and beyond the initial installation, the unit would need to be calibrated and serviced periodically to make sure it was performing as expected – ie validated.

2) Sample processing is another concern. Many of the standardized (NIDA/SAMHSA) accepted methods require relatively extensive processing prior to injection on the GC – i.e. liquid-liquid or solid-phase extraction, followed by acid hydrolysis to remove glurcoronidated species, and/or derivatization to enhance detection/s/n. Would this be done else-where? All the ancillary equipment as well as lab reagents and consumables would be an additional financial burden. At 50+ urines a week, you would probably require 1 or 2 technicians to ensure sample throughput. Furthermore, being in pain management, your testing battery would far exceed the “federal 5”. This being the case, different sample preparation is likely necessary depending upon if you are assaying for the semi-synthetics, or full synthetics not to mention benzos/THC etc.

3) A final consideration would surround chain-of-custody and reporting of results. In today’s litigious society, I would want to have all my bases covered on the off-chance a disgruntled patient desired to contest results etc. While the laboratory software has made great leaps from when I used it, interpretation of results can be rather confounding at times. Who would perform data review and sign-off on results? Would you purchase freezers to store urine retains in case retesting was required?

These are just a few of my primary concerns with setting-up office-based testing beyond simple immunoassay. Throwing a GC-MS in the corner of the office is a far-cry from a gMP lab with validated equipment. I would be very interested in learning how a company would deal with these issues. If anyone has implemented this, or something similar, I would love to know more details about the setup… Best of luck
 
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