Wednesday October 2nd, 2013

8:00am-3:00pm
DoubleTree Hotel, Alsip, Illinois

Meeting Minutes

 

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, and Siemens.

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 of Illinois.

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 used/presented.

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 jball@cap.org.

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 Biomedical.

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:

1. ED: evaluation not the unconscious patient, hyper and hypo-glycemic patient and DKA patient

2. Critical Care: hyper-glycemic control

3. Nursery: efficacy of nutritional management and hypoglycemia

4. Floors: monitoring

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 sisbell@novabio.com

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 well.

• 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 planning.

• 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.

Respectfully Submitted,

Wendy Denk, MT(ASCP)