Minutes from
QC, Influenza, CHF and More
at the April 13 Meeting of the
Tri-State POC Network!

The spring meeting for 2005 was held at the Doubletree Hotel in Alsip, Illinois on Wednesday, April 13 from 8:30 AM to 4:00 PM.  The meeting was attended by 113 registered healthcare professionals and 11 students from Rush University as well as representatives from the program sponsors and vendors: Dade, Instrumentation Laboratory, 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 group had the privilege of listening to two presentations by James Westgard, PhD (sponsored by IL).  The first presentation, “QC Review: Principles, Practices and Problems” was presented in the morning session and the second presentation “QC On-board and Beyond” later in the afternoon.  During the QC Review presentation, Dr. Westgard discussed the evolution of Methods & QC and now that instruments have changed, the QC methods of the past no longer apply.  Unfortunately, the lab continues to practice the same old methods of QC (2 SD, CLIA minimums, etc) and while the lab may be in compliance, the instruments/methods may not be in control.  He entertained the group by his story of doing an inspection and while reviewing QC data, stumbled across the documentation: repeated, repeated, got lucky.  His suggestion is to select the right QC procedure (define the quality required for the test, evaluate method imprecision and inaccuracy, determine the size of medically important errors or calculate the method’s sigma metric and select control rules to maintain 90% or greater error detection) and implement that QC procedure right (implement a variety of control rules, use cumulative estimates when calculating the  online real-time monitoring for immediate error detection). Some Don’ts of QC: Don’t use 2SD control limits, Don’t use bottle values to calculate control limits, Don’t use medical decision limits as control limits, Don’t use the same control rules for all tests, Don’t just repeat the controls, Don’t rely on electronic QC alone and Don’t eliminate statistical QC in POC applications. A for the Dos: Do define quality required for each test, Do select QC procedures to minimize false rejections, DO select QC procedures to detect medically important errors, Do adopt modern QC planning tools, Do standardize QC operations, Do calculate control limits for your own laboratory data, Do provide computer support to analyze and interpret QC data, Do reject out of control runs, identify problems and eliminate cause and Do adopt a Total QC strategy to maximize cost-effectiveness of QC.


The second of Dr. Westgard’s presentations, “QC On-board and Beyond”, continued from the earlier presentation and focused on how to tie QC and Sigma metrics to on-board iQM (Intelligent Quality Management).  By using iQM, problems should be detected by the first patient. (iQM was discussed in the morning by Kevin Fallon, PhD, note next paragraph.)


Kevin Fallon, PhD first introduced the concept of iQM to us in August of 2003 when he gave a presentation on the then-new Gem Premier 3000.  He outlined how there are two approaches to quality management: the traditional method where a sample with a correct known value is analyzed and the future approach where an instrument’s computer can automatically check performance of each component that can contribute to error.  With the GEM Premier 3000, by using QC, you are measuring a change, by using iQM, you are measuring a delta variance.  If the iQM system detects a delta, it performs further checks and if possible, initiates a process to “fix” the problem unlike the more traditional method of not “catching” an error until QC is initiated hours later.


Following break, Michael Costello, PhD presented “Rapid Detection of Viral Respiratory Pathogens”.  He said the decision for the selection of respiratory viral rapid detection methods should be based on the sensitivity (high positive predictive value), specificity (High negative predictive value), complexity (special training or FTEs needed), utility (TAT, diagnostic value, prevalence, sample required) and cost (medical and financial value of the assay).  During non-epidemic times, rapid tests should be used for the negative predictability as the rapid tests only have reliable positive predictive value during an outbreak.  The best way of increasing any rapid Influenza or RSV test is to ensure that the optimal specimen is being taken.


Michael Neu, MT(ASCP), POCTE (Dade) discussed “The Natriuretic Peptides and Congestive Heart Failure”.  After providing an outline of heart disease in the US and presenting the statistics for Cardiovascular disease, Mike discussed using the Natriuretic Peptides (ANP, BNP and CNP) as a CHF marker.  An ideal marker for CHF management should be highly sensitive and specific for HF, able to be reproduced and standardized across different labs, the CV should be low enough across range that small changes in level reflect true changes in clinical status, changes reflect changes in clinical status and in prognosis, easy to perform and analyze and not significantly influenced by gender, age or race. Mike provided a comparison between the BNP and the proBNP, identified who has what method (Dade, DPC, Abbott, Biosite, Shionogi, J&J-Ortho) and the intended use of the NT-proBNP method on the Stratus.


Sharon Ehrmeyer, PhD, provided an update on “POC: CLIA,  JCAHO & CAP Regulations”, always a welcome topic amongst laboratory professionals. CLIA: The biggest change for waived testing is that all sites must now follow all manufacturer’s suggestions and that nonwaived test methods must have performance specifications validated or established for unmodified, FDA-cleared or approved systems. The nonwaived test method QC must monitor the complete analytical process, QC is performed every 24 hours (1 level every 8 hours for blood gas testing and 2 levels every 8 hours for coagulation testing), calibrate or check calibration every 6 months or when major change in reagents, instrument components, etc (except PT, ACT).  Sharon informed the group that there is a new concept introduced in the State Operation’s Manual, Equivalent Quality Control (EQC), not to be confused with Electronic Quality Control.  JCAHO has introduced the Tracer Methodology that focuses on improvement, patient safety and quality and beware of unannounced inspections in 2006.   CAP: New and changed checklists are due to be out by September 2005.


A raffle for a GEM Premier 3000 was sponsored by Instrument Laboratory and the lucky winner was Dee Cook from Memorial Medical Center in Springfield.  There were additional raffles and for those that won something, congratulations!  For the rest of us, we’ll hope for better luck next time.


The next meeting will be November 2, 2005 at the Doubletree Hotel in Alsip.

Serving Illinois, Indiana, and Michigan, our December meeting will provide an excellent educational opportunity for all who attend. So make your plans today!

Core Members:

  • Wendy Denk MT(ASCP) , Ingalls Memorial Hospital

  • Gil Salas MT(ASCP) , University of Ill. At Chicago Medical Center

  • Darlene Sobucki RN,CLS(NCA) , Advocate Trinity & South Suburban Hospitals

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