Wednesday October 2nd, 2013
The 2013 Fall meeting with
Vendor fair was held at the Doubletree Hotel in Alsip,
Illinois on Wednesday, October 2nd from 8:30 AM to 3:00
PM. The meeting was attended by 45 registered healthcare
professionals and sponsored by Alere and Nova
Biomedical. Registered vendors included: Alere, BD,
Beckman Coulter, Fisher HealthCare, Helena Laboratories,
Innovative Medical Systems, Nova Bio-Medical, PTS Inc/CardioChek,
The meeting commenced with opening remarks by Gil Salas.
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 and Sandra Curran, Univ
The first session, “Update from CAP – What is New for
CAP Accreditation”, was presented by Jean Ball and was
was sponsored by Alere. There has been a globalization
of the CAP checklists so there will be checklist
questions for laboratories subject to US regulations
added. The new checklists will also include R.O.A.D
notes stating what is required and what evidence is
needed for compliance. If the statement says MUST, that
is a requirement; if the statement states evidence of
compliance, these are EXAMPLES of what could be
The ALL COMMON checklist will now contain the Reagents
and Quality Sections. Also added to the ALL COMMON is
COM.04050 – Unusual Laboratory Results and how to handle
the manual entry results.
The POC Checklist POC.06900 refers to Competency
Assessment. Citations will be given for not using the 6
elements for non-waived testing, not documenting the
initial two assessments in the first year and not
believing that these requirements apply to non-laboratorians.
As to WHO can assess moderate complex testing personnel,
assessment needs to be performed under a Technical
Consultant. Respiratory Therapists need to be assessed
by a MD or MT if the therapist does not have a BS.
Moderate complex testing personnel must have a diploma
or transcript and primary source verification on file.
There will be an audio conference in November discussing
IQCP that will be replacing EQC, effective 1/1/14; EQC
will expire 1/1/16.
New checklist additions will be released in April 2014
and then in spring of 2015. The 2015 checklist may
require two wet controls each day of testing. If there
are any questions about the new checklists, contact Jean
Bell at email@example.com.
Following the Vendor Fair and lunch, “Hospital Point of
Care Glucose Testing – Challenges and Performance
Expectations” was presented by T. Scott, PhD, DABCC,
FACB Director of Medical & Scientific Affairs, North
America, Nova Biomedical and sponsored by Nova
There are a variety of glucose devices available and Dr.
Scott's presentation focused on the hospital based strip
devices and the special applications related to
hospitals. There were four areas addressed:
ED: evaluation not the
unconscious patient, hyper and hypo-glycemic patient
and DKA patient
Critical Care: hyper-glycemic
Nursery: efficacy of
nutritional management and hypoglycemia
In 2013, the FDA indicated
that guidelines are in the making for tighter accuracy
(currently the variance is +/- 15%). CLSI standard
POCT12-A3 is specifically written to address the use and
evaluation of glucose meters used in the hospital to be
+/- 12.5% variance and under 75 mg/dL to be +/- 15 mg/dL.
The meters must be validated for the patient populations
where they will be used (nursery, critical care, OR).
Pre-analytic challenges include: improper dosage,
specimen collection, storage of strips. Education will
be needed to address the errors.
Anaytic errors are structurally similar substances that
can interfere with the electrochemical substances such
as maltose interference that could lead to a false
hyperglycemia or for increase hematocrits resulting in
decrease glucose levels or decrease hematocrits and
increased glucose levels.
Questions may be sent to
Sandra Curran led the Roundtable Discussions.
What has your lab done and
how is your policy worded on the use of the meters
on critically ill patients since the meters have not
been specifically approved for this use? Dr. Scott
provided some examples to validate the meters: use
routine samples arterial or venous and perform the
glucose on the ABG analyzer, the glucometer and the
chemistry analyzer and record the hematocrit as
IQCP – Individualized QC
Plan (information only as some did not know)
Lab Competency Assessments
– not the same as a performance evaluation
Has your hospital included
you lab in their risk analysis? CLSI is writing a
guideline document to include POCT in disaster
What, if any, is your lab
participation in INR home monitoring, instruments or
home glucose meters?
How have your laboratories
been handling the interim CAP self inspection. Has
anyone requested that data from you?
There will be no spring
meeting; the next meeting with a Vendor Fair will be
October 8, 2014 at the Doubletree Hotel in Alsip.
Wendy Denk, MT(ASCP)