The Braun Case: Good clinical practice, steroid (PED) abuse testing, and HIPAA violations

I heard Dan Patrick pontificate on the Ryan Braun situation today. Apparently these sports commentators have Ph.D.s, JDs, and a host of other professional degrees, at least in their own minds.

They also do not need to reveal sources (talk about a slippery slope; what if the source is their dog, ie made up).  Patrick kept referring to "I was told", and "sources".  He made these points:

• Bruan had some huge quantity of synthetic testosterone in his urine.  (actually his T:E as reported was 20:1; 5:1 is usually the cut off for suspicions)
• The issue should not be chain of custody
• Braun should not pursue legal remedies, what what he sue for?  (defamation for a beginning)
• That the chemists are always ahead of the testers (ah he has a Ph.D. in biochemistry now)
• And that big names are enrolling in an MD lead PED program to beat the system (assuredly based on the East German Doping Machine, chuckles)

In medicine laboratory and clinical, the procedure and the processing is vitally important.  If a sample is mishandled, or stored incorrectly, or allowed to warm up (in some cases) the lab values may be in error, and not reliable.  Biologic molecules can decompose, enzymes can metabolize substances, results may be affected.  For experiments, freezers are monitored for constant temperature, labels are clear, and the process is transparent.  If there is a breech, the data is discarded, or should be.

And even then..

Example, I knew of a patient who was told by a physician of standing that he had Hepatitis C, based on high bilirubin.  That was the only value.  I looked at the lab, astonished to hear the conclusions, because nothing else appeared in line with Hep C.  There is a natural variant called Gilbert's Disease where a person walks around with elevated bili.  On retesting that was exactly what the patient manifest - Gilbert's and not Hep C.  So he was given a 'death sentence' based on one lab value.

Thus if there is a breach in protocol, the test is invalid, and it did not happen.  No you cannot reconstruct the results, forget it.  Check out the post on DNA analysis.  Degrdation of lab tests here, here and here.

What is the ideal temp for urin storage?  See below.  The average refergerator is from 35-38C.  And is the household refergerator certified for storage?  BIG OOPS!

But multiple sources said the sample was not shipped for testing as soon as possible, as required by the drug testing policy, and instead was kept in a cool place in the sample collector's home. Sources told ESPN legal analyst Lester Munson that the collector left Braun's sample on a desk in a Tupperware container and left it there for two days.

In retrospect, this was an easy case to arbitrate if the above were true.  Throw out the sample.

So why were Braun's values 'leaked' to the press -- who is going to distort the issue, and hold some kind of kangaroo court on it?  Could this be a HIPAA violation (Health Information Portability Accountability Act)

The Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) establishes, for the first time, a set of national standards for the protection of certain health information. The U.S. Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).¹ The Privacy Rule standards address the use and disclosure of individuals’ health information—called “protected health information” by organizations subject to the Privacy Rule — called “covered entities,” as well as standards for individuals' privacy rights to understand and control how their health information is used. Within HHS, the Office for Civil Rights (“OCR”) has responsibility for implementing and enforcing the Privacy Rule with respect to voluntary compliance activities and civil money penalties.

A major goal of the Privacy Rule is to assure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being. The Rule strikes a balance that permits important uses of information, while protecting the privacy of people who seek care and healing. Given that the health care marketplace is diverse, the Rule is designed to be flexible and comprehensive to cover the variety of uses and disclosures that need to be addressed.

Clearly there was a breach of confidentiality, unless Bruan gave his consent to releaqse information to ESPN.  The issue is 'covered entitiy'.  Is MLB a 'covered entity' testing employees for drug abuse? Sounds like one law firm may answer positively.

The new Health Insurance Portability and Accountability Act rule on privacy scheduled to go into effect on April 14 may reach as far as the disclosure of information about workplace drug testing and substance abuse management. The Standards for Privacy of Individually Identifiable Health Information, known as the Privacy Rule, generally will prevent "covered entities" from disclosing protected health information to non-covered entities without authorization from the subject of the protected health information. The disclosure requirements may apply to many collection facilities, laboratories, Medical Review Officers and other service providers who analyze and review applicants' and employees' drug and alcohol test results.

"Covered entities" under HIPAA must require employers using their services to provide HIPAA-compliant authorization before releasing drug and alcohol test results (i.e., protected health information) for employees and job applicants. Forms currently being used by employers for this purpose may not meet the requirements of the regulations which identify the key components and specifics for the authorization form. Additionally, the forms must be signed by the employees or applicants. As a practical matter, since HIPAA compliance ultimately falls on the shoulders of the "covered entity," the collection facility, laboratory or Medical Review Officer may have its own authorization form for employers.

In addition to the release of test results, other aspects of an employer's substance abuse policy may require use of a HIPAA-compliant authorization form. For example, when an employee enters into substance abuse rehabilitation, an employer may require progress reports from the substance abuse professional who evaluated and treated the employee. If the substance abuse professional is a "covered entity" under HIPAA, the employer may then be required to have the employee sign a specific HIPAA-compliant authorization form permitting the release of the "personal health information", i.e., the substance abuse professional's records, to the employer.

Baseball has cited HIPAA to assure privacy in medical matters before.

The polyps have bothered Rivera recently. Yankees general manager Brian Cashman, citing HIPAA privacy laws, has declined to talk about the issue because it is not baseball-related.

In fact it is reported MLB requires players to sign a HIPAA statement.  Athough this author doesn't think it is a HIPAA violation, I have been on hospital boards that rang up people for far less a HIPAA violation, This might be a MALIGNANT HIPAA violation.

My conclusions:

• If there was a violation in laboratory protocol THIS LAB RESULT, THIS SAMPLE DID NOT EXIST
• Ryan Bruan's attorney's should be looking at defamation and HIPAA violations.  An HIPAA violations not a laughing matter.

I still say Braun should not expose those abs, which are quite unusual for baseball....  ^^

References:

German documentation of tampered doping urine samples.

From this paper:  Detecting the Administration of EndogenousAnabolic Androgenic Steroids
Christiane Ayotte (name sound familiar, she is head of the Montreal Lab)

2.3 Stability of Urinary Steroid Conjugates
Testosterone glucuronide is known to be stable in urine for at least 1 year when the
specimen is stored below –20C (Venturelli et al. 1995; Robards and Towers 1990),
while one study reported the formation of free testosterone and free dihydrotestosterone
in urine samples kept at 18 and 37C (Kjeld et al. 1977). Testosterone and
epitestosterone conjugates are stable for months in sterile urine kept at 4C and
–20C (Jime´nez et al. 2006), while the addition of a bacteriostatic agent was
required to preserve their integrity in urine samples kept at 4C and 37C for a
week (Saudan et al. 2006). Spiked in sterile urine, authentic standards of androsterone,
etiocholanolone, testosterone, epitestosterone sulfates and glucuronides are
stable even upon incubation at 37C; dehydroepiandrosterone-3b-sulfate, like other
sulfoconjugated steroids, is less stable showing partial deconjugation. Since samples
are not collected under sterile conditions, skin bacteria and intestinal microflora
(staphylococci, enterobacteria, E. coli, etc.) are often present. Delays in
delivering the samples to the laboratory and improper refrigeration during transportation and storage may offer good conditions for microbial growth; the effects on the urinary steroids are easily detectable and consist mainly in the hydrolysis of the steroid conjugates and in oxidoreductive reactions leading to
the abnormal presence of steroids in the free form and the accumulation of 5aand
5b-androstan-3,17-dione, the b-isomers being more rapidly altered. Signs of
microbial degradation should obviously be absent to ensure the accurate measure
of the steroid profile (Ayotte et al. 1996, 1997; Hemmersbach et al. 1997).

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