Bay Area Point of Care Coordinators

Regulatory Challenges -
A Recap of the Spring 2006 Bay Area Point-of-Care Coordinators Meeting

 

The Bay Area Point of Care Coordinators (BAPOCC) recently held their Spring meeting in Walnut Creek, CA. Striving to offer an event that delivered significant value to its members and avoid another “dry” seminar, Robyn Medeiros, QA/POCT/Education Manager at El Camino Hospital and Susan Woo, CLS, MT(ASCP)M of Kaiser Permanente collaborated with RNA Medical to secure quality control industry renowned professor, author and AACC speaker, Sharon L. Ehrmeyer, Ph. D. as the keynote speaker to anchor the day’s event. Professor Ehrmeyer delivered two very interactive and informative presentations, the first on recent updates in POC testing regulatory requirements and the second on building a quality control program for POCT. She emphasized the need for all laboratories and POC testing areas to develop a rigorous quality control program and to approach electronic and automatic QC programs with caution. In her presentation, Dr. Ehrmeyer stated that “there is a very important role for external liquid QC and that will never go away.”

Also presenting topics were Howard Koo, Regional Director of Laboratory Quality and Compliance, from Kaiser Permanente and Jackie Coleman, Ph. D., Sr. Clinical Scientist, for Accumetrics. Mr Koo talked about the unique requirements of the state of California with regard to laboratory quality and regulatory requirements. He also emphasized that quality control is more than a matter of compliance; it is critical to patient safety. Dr. Coleman presented a lively discussion of how the Accumetrics VerifyNow™ assay is used to determine the level of patient response to aspirin or Plavix® therapy. Peer-reviewed studies were presented that show by assessing a patient's level of platelet inhibition, therapies can be adjusted, as well as bleeding levels predicted, providing an improved outcome for the patient.

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Rounding out the day’s events was a panel discussion that featured Professor Ehrmeyer, Mr. Koo, Valerie Ng, Ph. D., M.D., Director of the Clinical Laboratory at Alameda County Medical Center and Mr. Randy Byrd CTO/VP R&D from Bionostics, RNA Medical’s parent company. Many of the questions focused on gaining an understanding of how to reconcile CLIA, CAP, JCAHO, COLA and California state requirements. A significant number of questions surrounded the quandary of when, where and how to employ electronic and automatic QC offered on many of the newer blood gas analyzers. The general consensus was that there is still a significant amount of interpretation required by the laboratory, but that patient safety is paramount.

During the meeting, RNA Medical announced its newest quality control offering, the Safe-Wrap Combo Blood Collection Tube, used for the collection of capillary blood samples for use with i-STAT™ blood gas, electrolyte, and chemistry cartridges requiring either 95 μL or 65 μL of sample. These tubes are Mylar®-wrapped glass capillaries that have been treated with calcium-balanced lithium heparin.

Also sponsoring this fast moving and well-attended event were Abbott POC, Accumetrics and Triad Associates. Attendees received continuing education credits for Dr. Ehrmeyer’s and Mr Koo’s presentations.

For information on this or future events contact Paul Shea, Director of Sales and Business Development at www.RNAMedical.com.

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Return to PointofCare.net Home Page • Last updated:  06/27/2006