April Meeting Minutes
April 1, 2009
The 2009 spring meeting was held
at the Doubletree Hotel in Alsip, Illinois on Wednesday, April 1
from 9:00 AM to 3:00 PM. The meeting was attended by 44 registered
healthcare professionals and representatives from Genzyme, ITC, J&J,
Lab Supply Company, MAS, Radiometer, and Roche.
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 first topic, “Is Your Lab
Competency Assessment a Competent Assessment?”, was presented by
Jean Ball, MBA, MT(HHS), MLT(ASCP), Lead Inspection Specialist,
CAP. When asked “who is happy doing competencies?”, there were TWO
responders! As in 2 out of the 44 attendees! Competency is defined
as well qualified, capable, fit – NOT sufficient or adequate.
Assessment is to estimate or determine the significance, importance
of or value of and is determined by the process EVALUATE. Jean also
stated you must differentiate between training and education and
realize there is a difference between competency and
education/training. When asked what was considered “acceptable” by
the attendees, the level of acceptance was stated to be 80% or
better for their competency assessment. Jean stated that anything
less than 100% is unacceptable and that there has to be a plan of
corrective action to retrain and reassess the employee’s competency
(GEN.5700). Her comment was if you knew a lab accepted 20% error,
would you willingly bring your loved one to that lab when there was
a 20% chance the results might be in error? Competency must be
assessed following training, at 6 months and 12 months the first
year, and annually thereafter. And competency assessment isn’t just
for new employees but for every new test or instrument that is
different or when a new skill has been added. This includes bench
techs, POCT testers, working supervisors – and who assesses the
assessors? The assessor is to be validated by the Medical Director
who attests to the competency of the assessor by a formal statement
on the evaluation form. How can we assess competency? There are
three kinds of programs: home grown (quizzes, observation, record
review, demonstration, trouble-shooting), commercially available
(such as CAP) and hybrid (obviously a combo of the other two). And
why must we assess? Because “every number is a life”.
Following break, the group
gathered at one of the four round table topics: recent
experiences (that one was led by me after my most traumatic
inspection of my professional life!), critical values, PPM and
instruments/connectivity. These discussions have proven to be
helpful to the group so they will become an item on future agendas.
Following lunch, Dr. Jill
Huppert, MD, M.P.H., sponsored by Genzyme, presented “Beyond the
Wetmount: Improving the Diagnosis of Vaginal Infections”. The
objectives for the presentation: review the evidence linking vaginal
infections and health outcomes, understand the benefits and
limitations (including sensitivity and specificity) of new
diagnostic tests and discuss the implications of these tests on
screening and treating vaginitis. Why do a wet mount? Do vaginal
infections cause symptoms or signs? Are vaginal infections self
limited or associated with future problems? What is the evidence
linking vaginal infections and health concerns? Is wet mount
enough? There are three common conditions: Candida, Trichomonas,
and Bacterial vaginosis. Dr. Huppert discussed all three conditions
as well as methods of screening and testing.
The final presentation “Regulatory
Compliance Update” was presented by Diana Blanco, MT, SC (ASCP),
Manager of Clinical Applications, ITC. Diana discussed the
Implementation of a system: Precision, Trueness/Accuracy, AMR vs CRR,
Correlations (Type 1 and 2), Calibration, and Reference Ranges. She
also provided information on error and risk management, regulations,
the future, and inspection time.
Imagine Precision as the
Bull’s Eye of a target. Precision must be measured on each
instrument before general use by using 10 normal and 10 abnormal
samples if using control material or “spiked” matrix-appropriate
material. The degree of acceptable variance (CV%) is determined by
the manufacturer. Accuracy/Trueness is how close to the
“reference” value is the measured result. The manufacturer’s
specifications are used as the standard for acceptability. Accuracy
is also performed on ALL instruments, is performed over a minimum of
5 days/minimum of 20 samples, NEVER done in a single day to
accommodate variables in the testing environment. Analytical
Measurement Range (AMR), established by the manufacturer,
reflects the entire range of detection and must be included in the
written procedure manual for the POC test. Clinical Reportable
Range (CRR), or linearity, is validation of the operating range
of each POC instrument. A matrix-appropriate material rather than a
single analyte material is to be used and linearities need to be
evaluated on all instruments at 6 month intervals. Clot-based
assays for precision, accuracy and linearities present their own
challenges/problems and manufacturer’s recommendations must be
followed. Correlation Type 1: method correlation when
changing to a new system. Correlation Type 2; Instruments
are compared to each other AND the corresponding laboratory method
at 6 month intervals (clot based analyzers can use a single
instrument designated as the “key” that functions as the in-house
method). Calibration: moderate complexity has some
calibration but less than the Clinical Laboratory environment,
waived testing has no external calibration. Finally, Reference
Ranges are determined by testing healthy individuals
(non-hospitalized) that represent the population of the particular
geographic area. Determining reference ranges for Pediatric
patients presents a unique set of variables, for example pediatric
cardiology patients are not an adult in miniature.
And if you are having trouble
getting compliance from the non-laboratorian? Mention the word
“LIABILITY”, that’s the key to compliance.
The next meeting with a vendor
fair will be October 14, 2009 at the Doubletree Hotel in Alsip.
Respectfully Submitted,
Wendy Denk, MT(ASCP)
