Judy O'Rourke

Judy O’Rourke

As I’m writing, the Supreme Court has just ruled on health care reform—keeping its provisions largely intact. This welcome news for our industry comes on the heels of Congress passing the FDA Medical Device User Fee Bill. I’m sure both decisions will be widely discussed at the AACC annual meeting, which is still weeks away.

A Health Insurance Portability and Accountability Act of 1996 (HIPAA) enforcement deadline relating to electronic transactions—which had been extended 6 months to ease the transition for facilities—ended June 30. All HIPAA-covered entities must by now have adopted the Version 5010 standards, which is an update to the previous Version 4010/4010A. The Centers for Medicare & Medicaid Services (CMS) says that any electronic transactions from July 1 on not using Version 5010 will be rejected.

The American Academy of Microbiology recently issued its newest colloquium report, titled “Bringing the Lab to the Patient: Developing Point-of-Care Diagnostics for Resource Limited Settings.” Communication between stakeholders is cited as a key to the success of point-of-care diagnostic tests (POCTs), which continue to gain ground in the testing marketplace. The report is free and available to all at bit.ly/Lgk8Zf. As the acute needs of hospital patients increase, POCT for blood gases and other critical care tests is also expanding. An increasing number of blood gas/critical care analyzers is being used at the point of care to provide improved turnaround times for urgent tests such as blood gases and chem, helping to address the overcrowding crisis in emergency departments.

Growing use of point-of-care testing requires that devices are more automated. Biosensors on many analyzers provide top-notch accuracy through their analytical measurement range, and computerized self-monitoring of the analysis and calibration cycle provides accurate analyzer performance.

Aiming to provide the highest quality of patient care faster and more precisely while stymied by staff shortages, budget constraints, and increasing testing volume, clinical labs may cast a longing eye at automation to help rev up their operations.

While labs span all points on the continuum, from full manual labor to total lab automation, most fall somewhere in between. Most labs in the mature market have adopted fully automated analyzers, but not necessarily full automation. Semiautomated labs have become more commonplace, with small hospitals eyeing their automation options. With more labs heading in the direction of total lab automation, tasks such as those in the pre- and postanalytic areas may be automated, helping labs to leverage and stretch their resources.

Judy O’Rourke
Editor, CLP
, (619) 659-1065