October 10, 2007
Meeting Recap...


The 2007 fall meeting and Vendor Fair was held at the Doubletree Hotel in Alsip, Illinois on Wednesday, October 10 from 9:00 AM to 3:00 PM.  The meeting was attended by 52 registered healthcare professionals and representatives from: Abbott, BD, Biosite, Dade, Hemocue, Instrumentation Laboratory, Inverness-Biostar, ITC, Lifescan, MAS, Nova, Quidel, Radiometer, Randox, RNA, Roche, Siemens and Telcor.

The meeting commenced with opening remarks by Joanne McEldowney, RN.  Members of the core group include:  Wendy Denk, Ingalls Hospital, Harvey, IL; Joanne McEldowney, RN, Univ of Illinois – Chicago, Chicago, IL; Gil Salas, Univ of Illinois – Chicago, Chicago, IL. 

The session started with a two hour vendor fair giving the participants the opportunity to speak with representatives from twenty vendors and to view what is available in the POC testing arena.  As always, the Tri-State POC Network offers their thanks for the support of the vendors who make it possible for the group to keep meeting twice a year. 

Following the vendor fair and prior to lunch, Lisa Montes, BS, MLT(ASCP) presented “Warfarin Monitoring: Best Practices and Entering a New Frontier”. This presentation offered 1 PACE credit and was sponsored by ITC.  Lisa gave a history of coagulation, reviewed basic coagulation, discussed POCT methodologies from the “Stone Age” (1986) to current devices, and reviewed the current regulatory standards.   There are two types of PT/INR methodologies, mechanical clot detection (elapsed time between the start of test to completion in seconds) and electro-chemical detection (PT seconds and INR are calculated).  Devices today may be CLIA waived (ITC Pro Time 3, Roche CoaguChek S/XS and HemoSense INR Ratio) or Moderate complexity with lockouts and connectivity (ITC Response, ITC Signature + & Elite, and Abbott i-STAT).  There are 8 steps to system validation which must be performed to meet regulatory requirements: demonstrate system accuracy, determine/verify reference ranges, verify reportable range (AMR), demonstrate system precision, verify calibration, create policies and procedures, create a “Quality” procedure and training.  Lisa warns that it is important to remember that analysis using a different methodology will not produce the same results and that coagulation is not chemistry and variations exist even in lab to lab comparisons.  What is the acceptable variation?  According to the International Organization for Standards guidelines: an INR range <2.0 should demonstrate a < 0.5 INR lab vs. POC INR; and INR range 2.0 – 4.5 should demonstrate a < 30% change between lab and POC INR.

New for 2008 is the JCAHO requirement for Medication Safety to reduce the likelihood of patient harm associated with the use of anticoagulation therapy. As a result of this Patient Safety Goal,  Pharmacy will be required to have Policies on anticoagulation in place by 2009.  Warfarin therapy, heparin, LMW heparin (Lovenox) will need to have protocols written and in place by 2009.  What is on the horizon for anticoagulant testing includes: LMWH, Platelet function testing, genetic testing for warfarin therapy, and new pharmacologic agents. 

Following lunch, Sharon Ehrmeyer, PhD, presented “POC Strategies for Success: Building/Managing a Quality Program”.  Sharon has been a speaker for us on numerous occasions and we thank Dade Behring and Roche for sponsoring her so that we may once again learn from her knowledge of regulatory processes.  As she says, we cannot ignore the “elephant” in the room (a.k.a the Inspectors) but we can certainly benefit from an inspection.  Leadership is important for Quality Laboratory testing.  Leadership facilitates “self-evaluations, promotes learning (what are we doing? How are we doing it? Why are we doing it? Can we do it better?) and promotes the 8 “Rights” : Right test, Right patient, Right specimen, Right time, Right “Handling”, Right Result, Right patient record and Right response.  Three keys to eliminating quality failures is through QA and CQI processes: detection, correction and prevention.

New for 2007 – TJC: QC.1.77: Lab validates electronic or internal monitoring systems prior to use for routine QC.  Do the validation immediately, document the validation and get it signed by the Medical Director.  As for CAP, there have been changes made for waived testing.  CAP now recognizes waived testing and treats it differently and checklists are customized for the particular organization. With the POC.07300 – 10/31/06 checklist for non-waived testing: daily controls for quantitative and qualitative tests, validation adequacy of limiting daily QC to internal controls and frequency of external controls.  Both TJC and CAP are adamant about patient safety and have made safety a major inspection focus.  Sharon recommends looking for problems, identifying problems in your laboratory and correcting those problems will lead to fewer deficiencies during an inspection.  Tools to use: be objective, perform mock reviews and inspections (CLIA Certificates, QA/QI/QM plans, personnel training/competency, up to date SOP, proficiency testing, reagents, maintenance, documentation and safety goals), use systematic approaches to meeting requirements, used tracers (such as following a Potassium from order to completion following pre-analytic, analytic and post analytic phases).

As has become the custom, there was a mini raffle in which three lucky attendees walked away with a gift certificate compliments of Inverness.  Congratulations to Gail Paremba (Gottlieb), Lourdes Hinton (Provident Hospital) and Linda Bernhardt (Advocate Christ Hospital).

The next meeting will be April 2, 2008 at the Doubletree Hotel in Alsip.

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