Raritan the next Theranos

[anonymous]

It's well known routine PM's and QC are delayed daily to get specimens through. When will the first deficiencies be documented and made public ?

 

[anonymous]

It's well known routine PM's and QC are delayed daily to get specimens through. When will the first deficiencies be documented and made public ?

If it will save a nickel, we will cut any corner.

 

[anonymous]

with EH being banned, it is time the WSJ investigates the short cuts and off FDA label use of reagents and controls in Raritan.

 

[anonymous]

LDTs are perfectly acceptable under CFRs. The difference is we got the fancy spreadsheets and incomprehensible statistical analytical methods to prove that the method works.

 

[anonymous]

It's well known routine PM's and QC are delayed daily to get specimens through. When will the first deficiencies be documented and made public ?

Prove it. According to all the Pm charts and machine electronic records signed by our underpaid slaves we are the pinnacle of laboratory science.

 

[anonymous]

LDTs are perfectly acceptable under CFRs. The difference is we got the fancy spreadsheets and incomprehensible statistical analytical methods to prove that the method works.

Westgard rules to the rescue 22s 4x WHOOO lean = don't give a fuck about QC being out its just a statistical anomaly

 

[anonymous]

I would agree if the assays were validated as an LDT with the "statistical controls" however they are not submitted as LDT.

Additionally it criminal not to run the appropriate levels of control, do PM, or run QC in accordance with standard laboratory practices.

 

[anonymous]

Nobody cares. Docs don't care about patients. Just give them any old result that they can file. We are all gonna die anyway.

 

[anonymous]

http://www.marketwatch.com/story/th...employees-2016-07-10?siteid=yhoof2&yptr=yahoo

Doctors don't care, insurance companies don't care, ...but disgruntled employees who've been mistreated for years that can gather documented proof that this place is run on fear, deception and manipulation of statistics can grab a paycheck that they would never need to work again.

Bill knows, and He would settle every one of these quick, why not cash out.

 

[anonymous]

I would agree if the assays were validated as an LDT with the "statistical controls" however they are not submitted as LDT.

Additionally it criminal not to run the appropriate levels of control, do PM, or run QC in accordance with standard laboratory practices.

Wow. Ignorance to the max. A good 75% of the tests at any clinical lab are LDTs. Meaning labcorp sets the controls and appropriate reference values: high, low, and critical values according to what labcorp needs. You need to read up on 21 CFR 864.4020(b). Basically all lab tests except bloodbank, tb, hives, etc can be LDTs utilizing class 1 ASRs.

This also means labcorp chooses what standards and controls to use and what statistical bullshit to justify results all with no input needed from the FDA. Criminal or not you have no proof or evidence of wrongdoing unless you film 24/7 which is why there are no cameras in the lab working area.

Goodluck. Labcorp is airtight. You'd have to dig pretty deep to find anything egregious. NYS tried and tries everytime and the only thing they could try to cite labcorp was on "unqualified lab assistants operating instruments." HAHAHA. Took QA 2 seconds to blast that back to Wadsworth and had that poor inspector running back to his momma with his tail between his legs. Yeah goodluck.

 

[anonymous]

Wow. Ignorance to the max. A good 75% of the tests at any clinical lab are LDTs. Meaning labcorp sets the controls and appropriate reference values: high, low, and critical values according to what labcorp needs. You need to read up on 21 CFR 864.4020(b). Basically all lab tests except bloodbank, tb, hives, etc can be LDTs utilizing class 1 ASRs.

This also means labcorp chooses what standards and controls to use and what statistical bullshit to justify results all with no input needed from the FDA. Criminal or not you have no proof or evidence of wrongdoing unless you film 24/7 which is why there are no cameras in the lab working area.

Goodluck. Labcorp is airtight. You'd have to dig pretty deep to find anything egregious. NYS tried and tries everytime and the only thing they could try to cite labcorp was on "unqualified lab assistants operating instruments." HAHAHA. Took QA 2 seconds to blast that back to Wadsworth and had that poor inspector running back to his momma with his tail between his legs. Yeah goodluck.

LCA skips running controls regularly and justifies it statistically. This is not an LDT. Plan and simple, there is not enough equipment to run that many patients a night. ROCHE, Sysmex, DiaSorin have enough info to put this into the light, but they wouldn't.

 

[anonymous]

Wow. Ignorance to the max. A good 75% of the tests at any clinical lab are LDTs. Meaning labcorp sets the controls and appropriate reference values: high, low, and critical values according to what labcorp needs. You need to read up on 21 CFR 864.4020(b). Basically all lab tests except bloodbank, tb, hives, etc can be LDTs utilizing class 1 ASRs.

This also means labcorp chooses what standards and controls to use and what statistical bullshit to justify results all with no input needed from the FDA. Criminal or not you have no proof or evidence of wrongdoing unless you film 24/7 which is why there are no cameras in the lab working area.

Goodluck. Labcorp is airtight. You'd have to dig pretty deep to find anything egregious. NYS tried and tries everytime and the only thing they could try to cite labcorp was on "unqualified lab assistants operating instruments." HAHAHA. Took QA 2 seconds to blast that back to Wadsworth and had that poor inspector running back to his momma with his tail between his legs. Yeah goodluck.

Elizabeth Holmes was certain she was right too.

 

[anonymous]

Is Labcorp really accepting 34% of Medicare for UHC contract?

How can they operate a lab at that costs, you still need people to run instruments and QC

What will they report to PAMA?