Minutes from our
August 4, 2004 Meeting

The 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.

The 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.

The first presenter for the day, Dr. Gregory Shipp, was sponsored by Abbott.  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 monitoring.  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.  

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The 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 acceptable?  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.

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Following an Italian buffet lunch, we listened to the “Guru” Sharon Ehrmeyer, PhD.  Sharon’s presentation, “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.  Other highlights: 

  • If an analyte on a PT wasn’t scored, some action needs to be taken and not ignored;

  • the accuracy of manual entries into a LIS must be ensured and the date and time collected included; 

  • any test after 2003 must have verification of performance specification.

She recommended downloading the Federal Register for the CLIA 2003 regulations.  

As 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 safety.  

CAP 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 Verification.  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 number!

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The 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.

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The 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 and 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

The next meeting will be December 1, 2004 at the Radisson Hotel in Alsip (will be the Doubletree in December), a vendor fair is planned.

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