Federal Case against BioLife Plasma
Challenging HIPAA Exlusion
Currently there is a Federal lawsuit against BioLife Plasma where a Texas donor who happened to know a lot about HIPAA got banned for a false positive hepatitis B result When his attorney confirmed that plasma centers had lobbied to make sure they don't fall under HIPAA, he questioned how that was even possible.🤷
He saw a medical doctor who screened him and recorded vitals and other diagnostic info including history in with his demographics and therefore created or added to a "medical record".🤔
The lab electronically transmitted his lab results to the National Donor Deferral Registry (NDDR) and to the local plasma center (45 CFR Part 160 and Subparts A and C of Part 164) who then printed out deferral notification paperwork which had the company's form version date on it showing it hadn't been updated in years. This made him wonder what else was outdated and he asked for copies of his registration paperwork to see what he actually signed when he first came to BioLife. There were delays and refusals saying a manager had to do it or some other excuse and when he called them out citing HIPAA deadlines, they of course said they're not covered under HIPAA.
He provided the center copies of multiple subsequent tests showing he wasn't currently positive for hepatitis B and never had been nor had had a recent vaccination for hep B that could have caused the false positive.
When he requested they update their records and the NDDR citing the specific right he thought he had under HIPAA 45 CFR § 164.526 and Texas Health and Safety Code § 181.102, and they ignored or refused his requests.
So he had our legal consultant look at everything and it turned out not only were the donor's waivers and authorizations and rights in his paperwork predating the most recent FDA guidelines, but the actual lab tests they performed and their interpretation of the results had also been considered scientifically obsolete and had alternate recommendations under updated industry standards.
The deferral notification also had said called their "medical providers" with any questions and to talk to his own doctor about his results. Referring someone based on a diagnostic test result to is practicing medicine (when they lobbied lawmakers that they were not providing any medical service). They don't give everyone their results and say show them to your doctor.
So he sued BioLife. Just to cover his bases he made very specific requests for copies of his records, a log of disclosures of his information (45 CFR § 164.528), and to correct his records this time citing each appropriate HIPAA rule. BioLife's attorney's intercepted that request and told the donor's attorney to tell him to stop making HIPAA requests. Refusing to process requests for copies of and corrections to medical records and Protected Health Information (PHI) is also a violation of both HIPAA and of Texas Occupations Code § 159.006.
During the suit, BioLife offered a monetary settlement for damages but would not remove what they knew was incorrect information on their records and at the NDDR, thus leaving the donor with the continual stigma of having records reporting he had hepatitis. A federal court agreed to take the case and the legal consultant found some new strategies that may make this the strongest suit yet.
This is just one example of why we're here and how important it is to share your story and your paperwork. Maybe our legal consultant will find something in your situation that might help.