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)

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