LabCorp “is now concurrently conducting an investigation and re-processing the samples of the affected customers,” 23andMe told its customers. As a result, 23andMe is “deliberating” …on… “completely automating the sample analysis, and implementing further checks of the data before it gets loaded into customer accounts.” Reading between the lines, it appears that the company no longer has faith in LabCorp’s test results. Based on my personal experiences and that of those posting on this site, LabCorp always claims to be investigating the matter when something goes wrong. I have yet to see something come out of any of their investigations and wonder if they’ll actually do something about it this time.

23andMe is a retail DNA testing service provider that is partially owned by Internet giant Google. They provide the patient a test kit. The patient then collects their own saliva samples and the company sends it to LabCorp for DNA testing. LabCorp provides the results to 23andMe who then provides the results to the patient through their website. They claim that they do not provide medical advice to their patients. 23andMe has recently and suddenly become a target of an investigation by Congress.  As a result, the company announced that it will soon begin providing genetic counseling to new and existing customers.

The United States Department of Labor is investigating Labcorp for not being in compliance with their affirmative action plan and for discriminating against certain sectors of the population. In a recent letter received by LabCorp Sucks from a former employee, the U.S. Department of Labor, Employment Standards Administration’s Office of Federal Contract Compliance Programs requested that their Jacksonville, Florida office consider the allegations made by the former employee when conducting future compliance evaluations of Laboratory Corporation of America

If Laboratory Corporation of America (LabCorp) is found to not be in compliance and fails to correct the problems, they can be sanctioned and could even be restricted from participating in the Medicaid and Medicare program, two major income sources for the Laboratory company. LabCorp can also be prohibited from participating in other government programs, including the CHAMPUS program (The Civilian Health and Medical Program of the Uniformed Services) that provides laboratory services to government employees, and to Veterans Administration program beneficiaries. LabCorp currently contracts with all these government programs to provide reference laboratory services to program participants. Since many HMOs that serve the beneficiaries of these federal programs also contract with LabCorp, the HMOs would also be restricted from using LabCorp. The loss in business could be in the hundreds of millions and could be catastrophic to LabCorp stock (NYSE: LH).

LabCorp’s discrimination problems have been well known to company insiders. The company has various lawsuits pending and has had to settle others by paying out millions. In a recent Florida case, LabCorp even had to fire the law firm representing them after accusations of obstruction of justice by the firm.

LabCorp’s total revenues for the fourth quarter rose to $1.17 billion, up from $1.12 billion the year before. For the full year, the company had profits of $543.3 million, up from earnings of $464.5 million in 2008. The increase also includes all the income from the labs that Labcorp has acquired.

Labcorp also announced that it will be spending $250 Million to buy back shares of their own stock. Labcorp’s Chairman and CEO David King said “ We remain optimistic about the growth opportunities that lie ahead for us in 2010, and we are well positioned to capitalize on them.”  I highlight the word lie because while he was making the statement, he was filing with the Securities and Exchange Commission that he had just sold shares of LabCorp stock and pocketed over $171,960 in profits. You would think that when the head of a company announces positive results and claims to be “optimistic about the growth opportunities” he would be buying stock, not selling it. But then he owns lots of LabCorp stock and could have sold for other reasons.

One thing that LabCorp CEO David P. King didn’t boast about is that of a rumored investigation of LabCorp by the US Department of Labor, Employment Standards Administration, Office of Federal Contract Compliance Program. According to posts in CafePharma.com, LabCorp’s Florida operations are in trouble. They had to settle an employment lawsuit at a rumored cost of about $2.7 Million. In addition, they have a pending Federal lawsuit from a former employee that has not gone too well for them. With allegations of witness tampering and obstruction of justice, LabCorp has had to fire the law firm that was handling the case. The posts include the following:

OFCCP would like to hear from those who have been discriminated against based on a protected characteristic. (personal info removed) A formal recommendation has been made for an investigation of LCA Florida. Those who aren’t afraid to get their hands dirty, write:

US Department of Labor
Employment Standards Administration
Office of Federal Contract Compliance Program
Charles E Bennett Federal Building
400 West Bay Street
Room 939
Jacksonville, Florida 32202

or call:

(904) 351-0551

SUBJECT: LABCORP CONDUCT IN FLORIDA.

 All correspondence is confidential. 

Well that was last month. Just a few days ago Labcorp went to the state and local governments in North Carolina for a handout of taxpayer money.  LabCorp wants to consolidate its billing operations and if it selects Greensboro as the location of the new facility, it would receive nearly $900,000 in taxpayer money. That’s free money from the taxpayers that will never be repaid.

He would like to hear from you if:

1. Your insurance company processed a claim for LabCorp services, and

2. LabCorp or LCA Collections billed you for a balance higher than the patient responsibility amount shown on your insurance company’s Explanation of Benefits (EOB), and

3. You paid the balance, or any portion thereof.

You can contact Mr. John Hoevel by emailing him at lab@hoevellaw.com. All emails will be kept confidential and you may have an opportunity to recover some of those over-billings.

If you are a LabCorp employee who knows about this or any other unethical practice by LabCorp, please contact Mr. Hoevel. Your statements can be very useful in stopping unethical actions by LabCorp and you and your job will be fully protected by the law under the Whistleblower Act. You might even get a reward.

I received this email from Natasha today. I don’t know what I would do if this LabCorp lab error occurred during a blood test on my child. It is devastating news that no one should have to endure as a result of a lab error.

Angelman Syndrome - Click for Large Image

LabCorp diagnosed my son with a rare genetic disorder called Angelman Syndrome by a Methylation blood work test. This syndrome is characterized with mental retardation, lack of speech, and seizures just to name a few symptoms. Our family was devastated, and we grieved for months.

When he got in to see a neurologist, he ordered another test to get more information about which type of the syndrome he may have. This test came back negative. We were shocked, but tried not to get our hopes up too high because we did not know which test was accurate. When we finally got in to see the geneticist, he ordered another round of genetic testing, this time a more detailed test called a cgh, as well as the original test. All negative.

LabCorp told the genetic counselor that they think they switched his blood. For privacy reasons they wont tell us anything, but assured her that they would try and find the child who really has this condition. As relieved as we were to have the good news, we are so angry for this mix up happening in the first place. Months and months of our lives were taken from us, and I still have not received one phone call from Lab Corp. We are unsure how to proceed from here. Anyway, this is an EXTREMELY abbreviated version of the story. Please let me know if you would like more information, I will do anything to help, no family should go through what we experienced.

My recommendation to Natasha is that she find a lawyer and sue LabCorp for punitive damages. A blood test lab error of this magnitude should be sufficient grounds for a lawsuit. One that I am sure LabCorp would settle quickly before the news quickly spreads and their testing service loses even more credibility.

The days between getting LabCorp’s lab results and finding out about LabCorp’s error were probably Natasha’s worst days of her life. No health services provider has the right to do  this to anyone. It’s obvious that Laboratory Corporation of America understands money, so they should pay for their mistake. In addition, government regulators should step in so that this never happens again.

U.S. labs employ 309,000 clinical workers, including 145,890 medical technicians who’s job entails running simple diagnostic tests, and 163,270 medical technologists who perform more complex tests. Technicians in the United States earn an average $17.36 an hour, or $36,110 a year. Technologists make $25.20 an hour, on average, or $52,410 a year. Technologists  require training comparable to that of a nurse, but earn less and have less chances of advancement. Besides low wages, job issues also compound the LabCorp problems.

Hospitals employ 97,370 medical technologists, that’s nearly 60 percent of the total. They also employ 64,300 technicians, or 44 percent. Hospitals tend to pay better for these jobs and therefore demand higher standards.

What does it all mean? Just read what their employees are saying in LabCorpSucks.com and that will give you an idea of how they feel about their employer. Another problem at LabCorp is the disproportionate amount of male to female managers. While a majority of the techs are female, the majority of the managers are males. It’s ripe for government action and sanctions under anti-discrimination laws.

WINSTON-SALEM, N.C. — April 11, 2009, A Triad medical company said it mistakenly faxed almost a dozen pages of personal patient information to the wrong number.The lab test results were sent from LabCorp, and were meant to go to Winston-Salem Health Care. Instead, they went to Leigh Ambruso’s home insurance office.

“I don’t know how to read test results,” she said. “I know enough to know I wasn’t supposed to have this information.”

For six days LabCorp sent information from about 12 patients to Ambruso’s fax machine. Originally, she said, she didn’t think anything of it. “I just want people to know this is happening,” she said.

But the faxes kept coming. Ambruso said she explained the error to someone at Winston-Salem Health Care who was supposed to get the information. “She said, ‘Do me a favor and fax them to me,’” Ambruso said.

She said she finally had enough and realized the fax was violating the Health Insurance Portability and Accountability Act (HIPAA). “I said, ‘If you send me one more fax, I’m going to call the patient and tell them I have their personal information,’” Ambruso said.

One of the patients….William Dull said he was anxiously waiting on results to determine if his cancer remained in remission. “It’s very upsetting,” Dull said. “It’s not being handled like it should be.”

No one at LabCorp would talk on camera. The company eventually responded.

“The fax number has been corrected in our computing systems to prevent similar incidents in the future,” the company said in a statement.

A Winston-Salem Health Care representative said that the company takes the security and confidentiality of patient information very seriously. “We appreciate the caller’s efforts to bring this situation to LabCorp’s attention so that it could be addressed,” a company representative said. Winston-Salem Health Care said it is still investigating the mix-up.

The FDA warning letter and possible criminal and civil action against LabCorp could be the beginning of the end for Laboratory Corporation of America. I say this because as one government agency moves against them, there are possibly other government agencies that might step up to further investigate other allegations against the company. It’s about time that this regulatory oversight process start. For too long LabCorp has focused on the buck as opposed to the law and the required quality standards. In my own opinion, it is a company that is out of control.

Here’s the FDA story:

WASHINGTON, Oct 8 (Reuters) – Laboratory Corp of America (LH.N: Quote, Profile, Research, Stock Buzz) is violating the law by selling an ovarian cancer screening test without regulatory approval, U.S. health officials said on Wednesday.

The OvaSure test does not fall in a category that can be sold without prior clearance from the agency, the Food and Drug Administration said.

“Because you do not have marketing clearance or approval from the FDA, marketing OvaSure is in violation of the law,” the agency said in a letter dated Sept. 29.

The agency told the company to “take prompt action to correct these violations.”

LabCorp spokesman Eric Lindblom said the company was “disappointed” by the letter.

“We are currently in discussions with the FDA over the next steps and of course we share the FDA’s determination to assure patients are protected,” he said.

The company started selling the blood test in June, saying it could detect early-stage ovarian cancer in high-risk women.

The FDA letter was posted on the FDA website. You can read the full letter by clicking here.

LabCorp shares (NYSE: LH) fell nearly 1.8 percent today to close at $60.63 on the New York Stock Exchange.

The US Food and Drug Administration is looking more closely at an ovarian cancer test from Laboratory Corporation of America after deciding that the existing data did not support the test’s commercial use.

 

The FDA Office of In Vitro Device Evaluation and Safety has asked Labcorp to discuss with the agency the utility of its OvaSure Yale test, after it learned that the performance characteristics of the test were based on research that is not representative of the intended pool of patients.

 

In a letter to Labcorp dated August 7, OIVD Director Steve Gutman wrote that the scientific community would not view the study as sufficient to establish performance characteristics for high-risk women who may have ovarian cancer.

 

“Based on our review of your promotional materials and the research,” Gutman wrote, “… we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health.” Gutman told Labcorp that OIVD would like to talk to the company about offering the test, and any other strategies the company may have for validating the test.