CLIA waived tests

Manky Badger · medicine forum Guru Wannabe Joined: 01 May 2005 Posts: 158

"fake name" <fake account> wrote in message
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fake name · medicine forum beginner Joined: 20 Jun 2006 Posts: 2

I remember when I as a student were sent to collect a sample from a
patient - I came and called out his name - "yes sir" - I repeated my
question - and he repeated his yes sir.
I asked for his birth day - and he answered yes sir.
I still hadn't got suspicious, so I asked if he was born on - and specified
his birth day - yes sir.

When collecting the blood was done - iI offered him a good day - yes sir.

In those days bracelets with identification was not used for anyone else
but babies on that hospital.
As you might have figured out the patient was not the one I was supposed to
draw blood from - and all he would say whatever you'ld say was "yes sir".

This was not even a labelling error - it was a plain stupid mistake.
If I learned anything from that? You bet!!!

JEDilworth · medicine forum addict Joined: 06 May 2005 Posts: 87

It never ceases to amaze me what nonlab people will do to samples just to
"get it done." Apparently some sort of result is what is sought, not
necessarily the right or best result for the patient. I cannot understand
this way of thinking.

My daughter is in pre-nursing courses, and I am slowly attempting to guide
her in the ways of the lab. My first wave of brain washing has to do with
labeling of specimens. I told her she will NEVER get in trouble with the lab
if she labels specimens immediately at the bedside before she even walks
away from the patient. I'll work on other issues as she gets to them Smile

.

The labelling issue is another one that sometimes is treated fast and loose
by nonlab personnel. [I just tubed it to you - can you send it back and I'll
put a label on it?] Most of the time, when I call up to convey the "no
label" findings, the nurses just groan. I know they're overworked and busy.
Collecting a urine/sputum/stool is just another hassle that they have to
cross off their huge "to do" lists. Our lab will absolutely not accept any
re-collectable specimen that is unlabelled or mislabelled. If it's a one
time specimen (surgical, CSF, tissue, etc.) they must bring a form from
nurse management signed by their manager and then sign another form in the
lab saying that they are responsible for labelling. We are across the street
and in the basement so it's quite a trek to get to us to do this. I've heard
of some labs requiring the offender to appear in front of a pathologist to
label specimens!

I'm sure everyone out there has a no-label story. The bottom line here is
that lab work is complicated. Adherence to the rules provides an analytical
result that can be trusted by the patient's physician. Once the specimen
reaches the lab, we have many other hoops to go through before a result gets
charted. However, we have to depend on other people to do it right at the
patient's bedside before the specimen gets in our hands. It really is a team
effort.

Judy Dilworth, M.T. (ASCP)
Microbiology

"Marsha" <marsha.mank@verizon.net> wrote in message
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Marsha · medicine forum beginner Joined: 11 Apr 2005 Posts: 4

I concur with John and Judy, QC and instrument maintenance is of utmost
importance in the reporting of laboratory results. Especially with K. Also
of importance is the manner the specimen is obtained. The specimen cannot
be hemolyzed because of the release of K from ruptured cells into the serum
which causes an falsely elevated K, often times to level which is clearly
not compatible with life. Nor can the sample be obtained with a purple top
EDTA tube. EDTA which contains K will also falsely elevate K.
I had a case where the emergency room nurse thought her serum separator tube
would be rejected due to be a short draw. She simply poured specimen from
the already collected purple top into the serum separator tube. We had a
dickens of a time troubleshooting the sample which gave us repeated answers
of greater than the instruments range. (And you cannot dilute samples to get
a result. Of course the Calcium was also nonexistent due to its being
cleaved by EDTA Smile

.Needless to say the patient had to be redrawn.

Marsha Mank MT(ASCP)

JEDilworth · medicine forum addict Joined: 06 May 2005 Posts: 87

John's right. There's a lot more to doing lab work in-house than the average
nurse or non-laboratorian realizes. You must adhere to equipment
maintenance. You must keep records of lot numbers of reagents or strips, and
record QC results on all of them. You cannot decide you "don't have time"
for QC because

a) the doc needs these results NOW and the machine isn't calibrated and/or
they haven't been done today, or you only have one strip left but you need 3
to do the patient and a high and low control
b) new lot numbers of reagents need to be QC'd probably upon receipt.
Records have to be kept of all of this
c) All your nurses have to be trained to do these tests and they all must
realize how important the QC is. This, for some reason, is a particularly
difficult concept for nurses. I'm not being mean. Nurses have learned
different priorities than lab techs have and QC is not included in nurses
training.
d) Stock of reagents must be rotated and kept at proper storage temperatures
[see story below]

The reason I'm going into this in detail is that, at one time, I was a
marketing rep for a regional reference laboratory. I was also a registered
MT at the time. One of our clients was doing in-house testing (a clinic) and
needed "help" with the lab portion of their operation. I was asked to look
into it since the clinic was in my territory. Even though I had worked
mostly in microbiology, I had performed lab work in other departments and
was familiar with QC. There was a piece of equipment at the time called an
Ames Seralyzer - probably a precursor to the I-STAT. Each of the tests
performed on the Seralyzer had a separate reagent strip. It was pretty scary
to find out that they were reporting tests on expired strips that had never
been quality controlled. The equipment had not been maintained and there
were no records of maintenance, even though their manual clearly stated what
needed to be periodically cleaned, etc. I won't even go into how horrifying
their attempts at microbiology were.....

I have another anecdote passed on from another tech who helped a doc's
office do testing. One day she was called to check on the potassium levels
that they were performing in-office. All the results were low (six or seven
patients). When she went over there she found they hadn't calibrated the
machine NOR had they run the QC (QC costs money and you can't charge for
it). Luckily they had saved the patient samples. When she calibrated and
retested they were all normal. I still wonder why the doctor didn't question
why everyone that morning had low potassiums (in critical range)? Was the
money all he cared about???

The last story involves an incident when I worked as a tech at the above
mentioned private lab before I went into marketing. A pediatrician's office
across the hall kept a pregnancy kit on-hand for surreptitious pregnancy
testing of teen patients who found themselves pregnant. They were sure that
one of their kids was pregnant but their test was coming out negative. They
brought the urine over to me to test. My test showed a definite positive.
When I went to investigate their kit was EXPIRED. It also had been stored on
the shelf at room temperature and NOT in the refrigerator, which was clearly
stated on the box. I nicely pointed out the problems to them.

If you're not willing to set up a program to do all the proper things to
test patients, many of whom are severely ill and deserve correct results,
please keep sending your lab work out to lab professionals.

Judy Dilworth, M.T. (ASCP)
Microbiology

John Gentile · medicine forum beginner Joined: 30 Apr 2005 Posts: 40

On 2006-06-14 02:58:11 -0400, "res" <Res1r09@hawaiiantel.net> said:

res · medicine forum beginner Joined: 14 Jun 2006 Posts: 1

I am just wondering, is there a test for potassium (K+) that is waived by
CLIA? How about BUN and Creat?

We are a dialysis center thinking to do tests in house instead of sending to
a lab.

Thanks
Res

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