Never thought...

Never thought I would say this but I hope Millennium tears Ameritox a new one with this lawsuit.

http://pathologyblawg.com/pathology-news/pathology-vendors/ameritox/millennium-laboratories-goes-after-ameritox-both-barrels-new-lawsuit/

 

You can really see that ML has very immature leadership to put such things in a suit.

I can name 5 offices that ML does the same for.

It's just plain childish

 

Childish or not it's illegal and will hopefully level out the playing field. This sh*t needs to stop now and I have a feeling this suit will change the industry.

 

This will level out the playing field. Negative confirmations and those ordering them are getting hit, not just the labs. The doctors are going to be pisssssssssseeeedddd. They are hitting up one ordering account to the tune of SIX MILLION DOLLARS!

http://floridahealthcarelawfirmblog....ting/#more-943

"The case is very instructive because imbedded in it are compliance related suggestions, some of which may not be apparent to many healthcare service providers, like:

Confirmatory testing of negative POCT results requires the healthcare provider has documented clinical reasons to believe the negative POCT was inaccurate or inconclusive.

Clinical labs must have a compliance program to detect and prevent healthcare providers from performing unnecessary POCT and ordering unnecessary confirmatory testing.

A clinical lab may not offer below market value POCT tests and consulting agreements in order to induce healthcare providers to refer tests.

Labs may not waive patient financial responsibility to induce healthcare providers to refer urine specimens to the lab."

 

Good thing you can copy and paste, However…

Negative confirmations still need to be completed. It's well known that POC and EIA are not very accurate and therefore confirmation should always be completed.

 

All EIA should be confirmed because it is unreliable? So EIA ia a bad test, and the confirmations need to be run every time? The FDA should stop approving these tests. Bad FDA. Since they are so horrible, why do EIA as a first step at all? Oh yeah. Ka-Ching! $$$$$$$$$$$ $$$$$$$$$$$$ $$$$$$$$$$$$$ Perhaps you should use EIA to confirm your superior testing always by Mass Spec?

 

You are way off base. Been brainwashed

 

By all means…show me documentation that backs up your statement and proves that EIA is accurate enough to ever be used in a court of law?

I will be waiting...

 

Why engage an idiot? Your statement about "always" is inaccurate. It doesn't take a lab to confirm everything. Your company doesn't focus on courts either. Fear is the company way to sell and intimidate.

 

Looks like I've engaged the idiot…you still haven't backed up your statement. Unless you have documented proof then shut your mouth.

Still waiting...

 

Lets put it back on you. Show everyone where it says what you wrote:
"Negative confirmations still need to be completed. It's well known that POC and EIA are not very accurate and therefore confirmation should always be completed. "

The term "always" is what needs to be proven. Also, you suggest confirming negatives is standard. Please share all references to support that.

As far as my supporting documentation, lets try: "medically necessary"

 

Anything can be "medically necessary". Try again. And to bounce back my original question is a chicken sh*t move.

 

Read the package insert of the IA POC test. It clearly states that due to cross reactivity it causes false positives and false negatives and one must not make medical decision's based on IA POC screen's. The package insert of all POC screening cups say that all results must be confirmed with mass spec. You are correct in that IA POC cups are worthless and there is no need for them if they have to be confirmed everytime to rule out false positives and false negatives. The only reason doctors use IA POC cups is for $$$$$$$$$$$$$$! They are total garbage and they will not hold up in court.

 

Read the package insert of a POC cup. It clearly states that medical decisions can not be made on these screens due to cross reactivity. It talks about the high risk of false positives and false negatives. The package insert of the IA POC says that due to cross reactivity the screening results must be confirmed with mass spec. You are correct in that IA POC tests are garbage! Why screen if the package insert says it has to be confirmed. Docs use POC IA testing only for the $$$$$$$$! They do not even look at the results because they know they will be wrong.

 

You pick and choose for your argument. What about the PIs that state "clinical consideration and professional judgment MUST be applied"?
If a doctor walks in the room and asks the patient if they smoked and they admit, it needs confirmation? Didn't the patient confirm it? It that confirmation test reasonable and medically necessary?
Other PIs do read that to get a "confirmed result" a more specific method "must" or "should" be used. They do not say a confirmed result must be obtained. These are very different statements.
You also assume that the doctor or mid-level failed to do other things necessary to determine if that result is correct. If the patient displays behavior and physical characteristics consistent with use, the combination of their observation, knowledge and the test result CAN be used after "clinical consideration and professional judgment".
If someone whose has no history of substance abuse tests negative on the screen, what is the medical need for testing them? POC IA is used as a reasonable screen in a timely manner. It has value beyond the $20. Testing and not using the results is not medically necessary and they should be audited and asked for the $$ back. Just like the labs who set confirmation target numbers for each cup.

 

Providers can not make medical decisions like discharging a patient if the results have a chance of being incorrect. POC screens work off of antibody-antigen complexes that compete for binding sites on the dip stick. Many compounds have similar structures which create false postives and false negatives on the screening cups. Providers hold themselves legally liable if they make a medical decision based off of a screen that can be wrong (ie. protonix and THC). I understand your thoughts on your THC example but providers are looking for a quantification for this compound. THC is a 3 strike and you are out offense at most offices. This compound is highly lipid bound and can stay in the system for up to 30 days or more depending on the patients metabolism and body weight. They look for continued quantification elimination ng/ml after the confirmed positive. Another reason confirmation is a must is that more than looking for negative illecit drugs we look for positive prescribed drugs to prevent diversion. POC screening cups do not test for many of the prescribed drugs and the ones they do test for do not pick up the different nor metabolites. This leaves the patient testing negative for a prescribed drug and accused of diversion when the patient was actually taking the prescribed med. If we made medical decisions based off of screening cups we would be out of business because we would have falsely accused everyone for diversion and discharged them. POC screening cups are great for work place testing because the employer does not care if you are taking your prescribed drug (Hydrocodone)that they DO NOT know about. They do well with just screening illecit's but more is needed for pain management testing. A dirty unreliable screen is OK for the point of care but a provider has to confirm if they plan on doing anything with the results.

 

I agree that MOST non-specific screening for a prescribed product needs at least one confirm. You don't have to confirm negative point of care results for drugs of abuse in the patient assessed at low risk.
While you provide some legitimate comments, your focus on "always" confirm and confirm everything remains incorrect.
It is apparent that you like to learn. Search and read what is developing in the legal world, insurance companies and the government. They don't agree with your "confirm everything" philosophy. They have more money, more resources and the facts on their side. Don't get sucked into the labs money earning marketing ploys and battling each other.
Clinicians are allowed to make medical decisions with a legitimate purpose, acting in the usual course of medical practice, and taking reasonable efforts to prevent abuse and diversion. There is no legal requirement for confirmation. The idea that a patient cannot be discharged without a confirmation test is simply not accurate. Medical and clinical decision making requires far more skill than a laboratory or point of care test. Where some labs have done the whole industry wrong is allegedly recommending numerous confirms, and charging too much.

 

Well at least we agree on "MOST" non-specific screening for a prescribed product...We are taking baby steps... I guess we will have to agree to disagree on the other. If in the future you need a heart cath to determine open heart surgery on yourself please advise the medical team to do a "SCREEN" rather than the actual confirmed catheterization quantifying the actual blockage and wheter it is the LAD or the RAD artery. They can base your open heart surgery off of the "stetoscope screen". Its very comparable to a screening POC cup. They both have a high percentage of false positives and false negatives but you should be alright. Once they open you up and see that you are clear and actually did not need the bypass they will just stitch you up and you will be on your way. No big deal... Better you than me...I know you are going to say, "you can not compare an open heart surgery to drug testing" but you can. These patients are suffering everyday with excruciating pain and they deserve to be told an accurate result. Not a result that has a high probability of being wrong. They go to a professional doctor of medicine who has specialized in pain to get accurate results not results that "could possibly" be accurate. They could very easily be discharged from their pain management therapy based off of unscientific incorrect screening results and struggle for the rest of their lives. I know you do not think that is anything to care about but you obviously have not been in chronic pain. You seem to have the insurance companies views and not care about the patient and that is OK.... to each his own. Do not get sucked into believing screening has a medical purpose in pain management. It is great for employee/workplace testing but is too unreliable for pain management. I understand your position on cost but I am thinking more on a scientific level. Maybe they can reduce the confirmation reimbursement to that of a screening... Would you still think a screen is better if the cost was the same? In regards to your comments on insurance companies, the legal world and the government you must be new to healthcare. They try to control healthcare by telling the actual medical doctor(someone who actually went to medical school) how to treat their patients. The insurance companies do not even know the difference between a screen and a confirm. They just know the cost difference. Its all about the money to them and not about the actual health of the patient. They are not the one's that are going to have to be legally liable when the provider discharges a patient and accuses them of diversion when they were actually taking it. They are not the ones that are going to have to discharge a 80 year old women for SCREENING positive for THC when she actually was just taking a proton pump inhibitor for her gastric reflux. I know this is not open heart surgery but serious inaccuracies can happen if you base your practice off of screens. More than that the provider will have to start mowing lawns because he will not have any patients left. They all will have screened negative for their prescribed drug and accused of diversion. Its not a marketing ploy... facts are facts...science is science. Screens are unreliable and you can not base any decision off of them. I actually think screens are the problem. The doctors should not be able to bill for such unscientific garbage. They do not even use the results because they know they are wrong. The only reason providers screen is for the $$$. You say there is no legal requirement to confirm... There is no legal requirement to get an actual confirmed cath before an open heart bypass surgery but I believe there is an ethical and moral obligation to know beyond a shadow of a doubt that before a sternotomy is performed there is confirmed evidence and it is medically necessary. In closing... screens suck and confirms are medically necessary if you are a provider and want to stand behind your medical decision. You maybe correct though...With all of this governmental data Obamacare may be pushing those "stethoscope screens" for open hearts in the near future if its all about cost and not about patient care.

 

If in the future, if you have to be screened by ELISA for HIV, and the screen comes back negative, the lab will not confirm the negative screen by Western Blot, another antibody based screen, but considered definitively a negative test. Further testing is not considered necessary. Don't get lost in the lack of some sensitivity by some benzodiazepine reagents in a study Millennium funded as being the basis of confirming every screen result, positive or negative. Screen by Mass Spec only if you believe it is the best possible screen, ands stop billing for the the "horrible and faulty" EIA screens.

Good science, and good use of health care dollars, and agrees with everything you you say.

 

I do not know anything about a Millennium study....I have just seen the faulty screen results first hand. I saw a patient test positive for COC on a POC screen a couple weeks ago. Thankfully the provider knew screening results were a preliminary result and needed to be confirmed per the screening PI. The provider sent the sample for confirmation before he had to make the decision to discharge the patient from his practice. The confirmation results came back negative for COC. The patient did not get discharged off of a faulty unreliable screening result because the provider was educated enough to know a screen is unreliable has has a high percentage of false positives and false negatives. This is just one example of thousands why the screening cup PI says to get confirmation and the screening results are just preliminary.