As an MLS and current laboratory manager, I will tell you that it is completely unreasonable to start a non-clinic attached lab. And at that, reimbursements are minuscule for most tests. I am the sole tech/manager etc. for a urology clinic. We run only PSAs and urine Micro. The net per sample is somewhere around $15 and it only works because a urology clinic pumps out a hundred of each of those a week. I wanted to bring other testimgbin house, but reimbursement is so small for all but the specialized/costly tests. CMP is about 55¢ per sample net, CBC is $1.25, UA is 15¢ etc etc.
Upfront costs for a lab will be immense. Between $20-45 thousand per instrument just For the smallest used instrument you can think of. You will need one for chem, heme, coag, immuno, UA and microscopy....Everything associated with micro (Fume hood, incubators etc.) You will need a $4-9 thousand annual service contract on each of those instruments, $2-10 thousand of consumables per instrument annually, you will need a facility which will cost who knows how much, you will need to purchase an EMR that links to the clinic you want to connect to along with the LIS (this will all be around $20-50 thousand plus annual fees depending on the EMR. You will also need proficiency testing ($200 per TEST per year)
Overall, you are looking at an up front cost of several hundred thousand dollars plus several tens of thousands annually in consumables and contracts. This is BEFORE staff. You will need no fewer than 3 techs to operate a full lab, preferably 5 or more so that there can be rotating schedules. You will also need 2 billing staff. Possibly a driver to collect samples, unless you want the techs to make that part of their job. Additionally, one person who is in charge of your QA program, community outreach, temp monitoring, supply ordering etc. Basically, you also have something like 6-10 full time staff to pay for. And you have NONE of the infrastructure or support that would be provided from being attached to a hospital, clinic or satalite facility.
There is a reason why Lab Corp and Quest are taking over everything from clinics, and even some hospitals. You NEED capital in the lab industry and you need massive volumes.
My lab at the clinic I work at only works because we only run 1 immono test and I convinced our board to purchase a fully automated micro system. Even then, we barely make anything on the micro, we only got it for reduced turn around time from our previous 5-7 days with send outs down to 2-4 days in house. That amount of supply is manageable for one person and the amount of billing was easy enough to Spears across the clinics current billing staff. And note, I didn’t start a lab by myself, they already had the instrument and wanted a tech part time (set my own schedule, perfect for being a college student). I did, however, jump through hoops to bring urine micro in house, however as stated it was not for the profits but after hearing one patient went septic after an 11 day turn around time without even reporting a gram stain that I just wanted our patients to have better care.
Overall, to answer your initial question, you would need a PhD in clinical laboratory sciences and past supervisory experience in each lab department you intend on pursuing. What I would do is instead get a masters in laboratory management to lead credence to and provide support for the bank to loan you hundreds of thousands of dollars and then find a pathology group who would be willing to supervise as laboratory director for a nominal fee.
However, as stated before, there is a reason that “start up laboratory” is not really a thing. The reference labs that are already in place WILL provide a better and cheaper solution and I would not recommend doing this plan.