Helping clinical laboratories meet proficiency testing needs

Dec. 22, 2016
Daniel C. Edson President,American Proficiency Institute


American Proficiency Institute (API) President: 1991—present
Surveys (Proficiency Testing) Manager, College of American Pathologists: 1980—1990.

MS, Michigan State University; received 2004 Distinguished Alumni Award. BS, Medical Technology, Central Michigan University

I am on the Board of Trustees at Munson Medical Center, a 390-bed regional referral hospital in Traverse City, MI. Prior to that, I was Board President of a free medical clinic serving the uninsured in northwest Michigan. I also enjoy bicycling, scuba diving, and cross-country skiing.

If you were explaining the American Proficiency Institute (API) to someone who is not familiar with the organization, how would you characterize its areas of expertise? What major services does API provide? API offers customer-focused, world-class service in all aspects of proficiency testing. We have more than 20,000 subscribers and continue to grow each year. Labs appreciate the personal attention they receive from our dedicated staff—from the live person who answers each phone call to the onsite shipping department to the paperless options available to them. API receives many accolades for our other major services, including Remedial PT, Troubleshooting samples, Verification programs, and free Continuing Education. We never forget that our primary mission is to help all laboratories perform accurate, reliable tests.

How does API serve the needs of labs of different types—for example, POLs, hospital-affiliated labs, clinics? We offer labs more than 600 analyte options in a menu-driven format so they can order the right option for their lab size. In the U.S., about 75 percent of the physician office and clinics and 50 percent of the hospitals utilize API for their proficiency testing needs. This requires us to tailor our services for that wide range of education and expertise with such a diverse client base.

On your website, you tell potential enrollees, “Every aspect of your proficiency testing is controlled by you.” Can you expand on that for MLO’s readers? We try to make proficiency testing as painless as possible. Labs can choose to go “paperless” for any of these three parts—PT result forms, results submission, and evaluation review—via our website. They can also choose to upload their PT results using DataDirect, a free, innovative process that uploads PT results from their laboratory information system (LIS) directly to API.

Laboratories can also customize their shipments. If they do not want to receive everything in one package, we can split the shipments by department (for example, Routine Chemistry, Point of Care, Respiratory Therapy). This way API sorts the samples and instructions for the lab before they leave our facility, and each department gets the samples they want.

New laboratory tests pose challenges related to proficiency testing. What are some novel proficiency testing samples that API has developed to meet those challenges? In the last two years we have developed dedicated molecular programs (including panels for blood pathogens, GI, respiratory, and meningitis) for multiplex methods, as well as specific molecular programs for Group A strep, Group B strep, Bordetella pertussis, MRSA, VRE, M. tuberculosis, Mycoplasma pneumoniae, and HSV 1 and 2.

Each of these new sample types takes time and money for the front-end science and pilot studies before our vendors can begin production. It can be a challenge to predict how many labs will order each of these unique new programs!

How has API responded to changes in regulatory requirements that affect its enrollees? Only 25 percent of today’s analytes are actually “regulated” by the Centers for Medicare and Medicaid Services (CMS). We have been working with the Centers for Disease Control and Prevention (CDC) and CMS for several years as they prepare to release new CLIA guidelines for analytes that were not part of the original CLIA 1988 regulations but play an important part in today’s medical decision making (e.g., troponins, BNP, tumor markers, D-dimer, and hemoglobin A1C). We have also collaborated with other PT providers to provide historical data and suggestions on grading criteria for newly regulated analytes, as well as revisions to current analytes that should be revised.

Please tell us about the benefits of API’s ongoing collaboration with the American Society for Clinical Pathology (ASCP) and The Joint Commission. API, ASCP, and The Joint Commission formed “LabAdvantage” in 2002 to offer labs a combined package of laboratory accreditation services, customized proficiency testing, and scientific educational programs. LabAdvantage subscribers receive additional discounts for their participation. In addition, all laboratory scientists at facilities that use API can receive up to 20 free continuing education credits each year.

How do larger industry trends impact API’s work—for example, automation and LIS interoperability, the trend toward personalized medicine, and the aging of the clinical laboratory workforce, with the accompanying shortages of med techs? We at API saw how the trends toward personalized medicine and a decline in the medical technologist/clinical laboratory scientist work force would require more output from fewer people.  To help our customers deal with this, API introduced DataDirect so that, using their own LIS or middleware, labs can transmit the proficiency testing results directly to us. This has been a game changer—no more transcription errors (which are the number one cause of PT failure)—and besides making proficiency testing truly accurate, immediate, and paperless, it saves valuable hours of time for the clinical laboratory workforce. We are proud that hundreds of laboratories use this option for submitting PT results.