Minutes from our
August 4, 2004 Meeting
first meeting in 2004 of the Tri-State POC Network was to be
held in Lansing , Michigan on April 6 but due to lack of
response was canceled.
The second meeting for 2004 was held at the Radisson
Hotel in Alsip, Illinois on Wednesday, August 4, 2004 from 9:00
AM t 3:00 PM.
The meeting was attended by 67 registered healthcare
professionals and representatives from the program sponsors and
vendors: Abbott, Bayer Diagnostics, Biosite, Fisher, IL, MAS,
RDI and Roche.
meeting commenced with opening remarks by Darlene Sobucki, founder
of the Tri-State POC Network.
Members of the core group include:
Wendy Denk, Ingalls Hospital, Harvey, IL; Gil Salas, Univ
of Illinois – Chicago, Chicago, IL; Darlene Sobucki, Advocate
Trinity – Chicago and Advocate South Suburban, Hazel Crest, IL.
first presenter for the day, Dr. Gregory Shipp, was sponsored by
His presentation, “POCT
– Impact on Patient Outcomes” included the objectives:
the need for POCT patient outcome studies, impact of POCT patient
outcome studies, how to execute a patient outcomes study, review
of the POCT literature, and recent and upcoming POCT patient
outcomes studies. Most clinicians know their patient’s outcomes
have improved with faster therapeutic turnaround times but there
have not been many studies or much literature written to
demonstrate or support this except for glucose and coumadin
Clinicians now need to perform clinical studies and create
literature and will need to work with the laboratorians to
institute appropriate, accurate and precise POCT.
Dr. Shipp presented an example of an outcome study
performed at Miami Children’s Hospital; Miami, FL: “Goal
Directed Therapy and Point-of-Care Testing Improve Outcomes After
Neonatal and Infant Congenital Heart Surgery”.
This study indicated an earlier intervention equaled a
better prognosis thanks to POCT.
second topic, “Controlling
Quality”, was presented by Kevin Fallon, PhD and
sponsored by Instrumentation Labs.
Dr. Fallon asked the key questions: How do we manage
something we can’t explain?
What is quality?
Is it measurable? When do you know if you don’t have it?
When do you know if you do have it?
Can there be too much or too little?
He stated a starting point would be to answer questions
such as: Does it meet CLIA requirements? And how much error would
be acceptable? As physicians act immediately on a POCT result,
there should be more emphasis placed on quality for POCT and that
quality requirements vary for therapeutic or diagnostic testing.
His discussion included how to validate performance using
Sigma metrics, a demonstration of standard statistical evaluation
vs sigma, and iQM (Intelligent Quality Management, a continual
monitoring of instrument functionality).
And to answer the question How much error would you say is
Dr. Fallon says that 1% error is equal to 4 Sigma.
He stated that lost luggage and Firestone tire failure have
a 4 Sigma.
If we say 1% error is acceptable in healthcare that means
we are equal to Firestone or lost luggage.
Obviously, 1% Quality in healthcare is NOT acceptable.
an Italian buffet lunch, we listened to the “Guru” Sharon
“An Update on POCT: CLIA, JCAHO, CAP Regulations”, was
once again informative.
She said that CLIA 2003 had no changes for waived testing
other than manufacturer’s directions need to be followed.
As for non-waived, moderate and high complexity were one
and the same.
an analyte on a PT wasn’t scored, some action needs to be
taken and not ignored;
accuracy of manual entries into a LIS must be ensured and the
date and time collected included;
test after 2003 must have verification of performance
recommended downloading the Federal Register for the CLIA 2003
for JCAHO and CAP, neither agency will follow the CLIA ’03
requirements until 2005.
Beginning in 2005, JCAHO will require verification for
moderate (nonwaived) complexity tests.
For 2004, the Elements of Performance (EP) are new as is
the Tracer methodology with the focus on quality and patient
changes include for Blood gas, one QC @ 8 hours and one low and
one high must be run @24 hours of patient testing; in hematology,
2 levels @ 24 hours for automated instruments.
And, as usual, the discussion of AMR, CRR and Calibration
The AMR is the range of analyte values that a method can
DIRECTLY measure without dilution, concentration or pre-treatment
that is not part of the usual assay process. CRR is the range that
a method can report ALLOWING for specimen dilution, concentration,
or other pre-treatment.
Calibration Verification confirms that the calibration
remains valid (calibration verification and AMR can be determined
at the same time).
CAP’s view on Method Correlation: include all
instruments, established subsets for each method can be compared,
and patient samples should be used for comparison.
And if your hospital has tests performed by physicians only
and they are currently under the lab’s CLIA number, get them out
from under the lab’s CLIA number and get them their own CLIA
fourth presentation, “Urine
Ratio Testing”, was sponsored by Bayer and presented by
Dr. Abraham Thomas.
Dr. Thomas stated that >350,000 people have kidney
failure which require dialysis and that number is on the rise.
He said that early stages of Chronic Kidney Disease (CKD)
can be detected thru lab testing and early treatment can delay the
progress of CKD as well as cardiac problems.
He further described the benefits of ratio testing in a
random urine sample in evaluating and monitoring CKD rather than
using the traditional 24 hour urine collection.
A random urine for protein and creatinine can be used as
the ratio is close to that of the 24 hour collection.
He did say that the use of a “spot” urine sample might
not work well for a large body mass, such as a body builder, so
the traditional collection would need to be used.
He also recommends getting an early sample from children to
detect early signs of CKD.
final presentation, "Perinatal
Rapid Testing Implementation in the State of
Illinois", was presented by Ann Staton.
The new law will affect all pregnant women in Illinois and
will be in effect in July, 2005.
The new law states that all pregnant women will be
counseled and offered a HIV test and the results will be
documented in the patient report.
If there is no documentation the test was performed or if
the mother refuses the test, the baby will be tested and treated
if the results are positive.
All positives will be confirmed by Western Blot.
If the patient is known to be HIV positive, pre-treatment
will be offered to prevent transmission to the baby.
Lab has to oversee the HIV rapid test but the test can be
performed as a POCT as it is a waived test
Pharmacy has to have IV AZT and AZT available for immediate use.
There will be a team of nurses/educators talking to all
facilities in the State of Illinois to discuss the law and
requirements as well as help in implementation of the program
next meeting will be December 1, 2004
at the Radisson Hotel in Alsip (will be the Doubletree in
December), a vendor fair is planned.