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. |