First CAP clinical laboratory accreditation in Chile

What does it take for a laboratory without any experience with, or neighbors who know anything about, the College of American Pathologists (CAP) accreditation and whose staff is not fluent in English, to obtain CAP accreditation?

The Specialty Clinical Laboratory at Clínica Dávila Hospital in Santiago, Chile received its College of American Pathologists (CAP) accreditation last December 11th, the first full-service clinical laboratory ever to be so accredited in Chile.

It was no small task, considering the language and cultural environment. Carlos Vega MT, the Administrative and Technical Director, drove this initiative despite the absence of a professional with knowledge of CAP accreditation in the country with whom to consult, and despite significant language barriers (CAP accreditation questions do not have an official Spanish translation). In addition, during 2018, while preparing for the accrediting inspection, the lab endured a hospital-wide 45-day strike, changed its chemistry instrumentation from Ortho to Roche, its middleware, its laboratory information system (LIS), its quality management data system and its laboratory Quality Manager, who left to join a commercial firm.

Despite these odds, the Clínica Dávila Specialty laboratory prevailed due to the strong culture and tradition of quality championed for years by Mr. Vega, an impressively competent staff and a strong resolve.

Carlos Vega (third from right), Dr. Cecilia Tapia, Laboratory Director (second from left) and some of the laboratory leaders preparing for the CAP inspection in April 2018

I am fortunate to have worked with this impressive group of laboratory professionals, personally during trips in April and September 2018, and remotely during the year, helping them translate their solid culture of quality into practices that are familiar to me. While language represented a barrier to some, it was the ability to internalize the pragmatic and rather literal style of quality that I practice in New York that underlies their success. 

The Dávila laboratory was already ISO 15189 accredited and, after a professional absence of more than four decades, I struggled with the extensive documents the laboratory had created to achieve that accreditation and with the rather philosophical emphasis on general principles and concepts prevalent in my native country of poets. It took many repetitions until they understood that the detailed requirements in the CAP accreditation questions meant exactly what was written. No more, no less. Much of the changes in documents consisted in trimming them down and in the simple measure of making them instantly available.

I will summarize my impression of the general differences between CAP and ISO 15189 accreditation in my next blog.