RE: specimen containers and HIPPA (HIPAA)
My previous responses to a similar query:
"Whether a specimen container -- or for that matter, a disposable bedside
pitcher, tissue box, or emesis basis -- that has the patient's name on it
qualifies as 'health information' is open to honest debate. Certainly, no
test results are recorded on the specimen container, and other than the fact
that it can be deduced that the patient with that name had a laboratory test
at some point in time, it seems to be stretching the definition of 'health
information' to include specimen containers... It is difficult to believe
that the crafters of the bill intended for laboratory workers to expose
themselves to additional infectious risk by obliterating the names from
discarded specimen containers, especially when there are additional federal
regulations mandating the proper disposal of such waste."
Harty-Golder B. MD, JD. HIPAA'S effect on laboratory waste disposal.
2001;July:14-5. Liability and the Lab column.
As a practical matter, such specimen containers can not be used for the
kinds of illegal purposes that prompted the HIPAA legislation in the first
place. IMHO, it is inconceivable that such non-deidentified specimen
containers pose any risk to patient confidentiality and privacy, as there is
no way to link the patient to the test outcome by dumpster-diving alone.
Labs should not go to cost-ineffective lengths to avoid a problem that
doesn't exist in reality.
And from the same article previously referenced (Harty-Golder B. MD, JD.
HIPAA's effect on laboratory waste disposal. 2001;July:14-5. Liability and
the Lab column.):
"Absent a clear ruling to the contrary or an exception defined in rule or
policy, the fact that failure to meet HIPAA's standards can result in
significant monetary penalties, (up to $250,000 per incident, depending on
the circumstances), has made most consultants and compliance officers err on
the side of caution."
So, it's not surprising that lawyers include "Other" in their list of HIPAA
do's and don'ts. Such conservative advice protects them. This issue
reminds me of the attorney who originally recommended that labs not bill
Medicare for unsat Paps without knowing anything about the process by which
a Pap smear is called unsatisfactory. She reversed her position after being
educated. I think the original HIPAA formulators just didn't think about
this particular issue. After all, there must have been a bunch of them.
Have you seen all the pages that comprise HIPAA? It's sobering to say the
Nonetheless, until Congress provides funding for the compliance police to
check whether labels have been de-identified on discarded medical specimen
containers, I don't think there's any practical consequences to not
de-identify such containers. Remember the window of opportunity for
would-be patient information thieves to act is small: the time between the
specimen container is put in biohazard bag and the time the bag is hauled
away to be disposed of in a manner prescribed by law. Of course, the perp
could always hijack the waste management truck and rifle through the
contents. And then what? Look up a randomly-selected patient's name in the
phone book, call, and ask her the results of her ThinPrep Pap test?
Of course, the usual disclaimers apply: I'm not a lawyer, I'm not a policy
maker, it's my personal opinion, etc., etc. It's tough to be rational in an
From: Kari Bradshaw [mailto:email@example.com]
Sent: Thursday, November 21, 2002 3:59 PM
Subject: specimen containers and HIPPA
I would like to know how people are disposing of their specimen containers.
Our retained tissue is eventually sent for incineration. However, the
specimen containers with the patients' names and other information are
rinsed and thrown away in the trash. During the grossing of small specimens
that submitted in full, the containers are also tossed. Trying to remove
the labels is nearly impossible and time prohibitive. What is the correct
approach under the HIPPA Privacy Rule? Would it be sufficient to send the
labeled container to the incinerator also? I have a very thick,
comprehensive book on the implementation of HIPPA, but it's not of much use
in regard to specimen containers and labels that contain patient
information. Thanks in advance.
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