Leading the Way With Accreditation in a Country of Firsts

By Patria Rivas Clinical Lab | Case Study

A Beacon for Top Quality Standards in the Dominican Republic

Occupying the eastern half of the West Indian island of Hispaniola, the Dominican Republic is often referred to as the “Cradle of the Americas.” The country’s bustling capital, Santo Domingo, housed the first permanent European settlement in the Americas and was Spain’s first capital in the New World, established by Christopher Columbus. Not surprisingly, historic firsts abound throughout the country and it’s hard to take a stroll without witnessing and experiencing New World milestones. Indeed, among the many firsts preserved in Santo Domingo are the first street (Calle las Damas); the first university (Santo Tomas de Aquino University, founded 1538); the first cathedral (Santa Maria la Menor Cathedral, founded 1540); and the first castle (Alcazar de Colon, built in 1512 by decree of Diego Columbus—Christopher’s son). Most recently, Santo Domingo found itself boasting another first—courtesy of the efforts of Laboratorio Clínico Lic. Patria Rivas, the city now hosts the first and only laboratory accredited by the American Association of Blood Banks (AABB) for Relationship Testing Activities in Latin America.

Founded in 1966 by Patria Rivas, the Patria Rivas Clinical Lab originally consisted of one room, with basic blood chemistry equipment, in the Dr. José Pérez Clinic. In 1991, Patria opened a standalone location and installed new equipment, which allowed her to broaden the scope of services offered. Her lab became the first in the country to perform DNA paternity testing.

“About 31 percent of households in the Dominican Republic are run by single mothers,” notes Patria, who is still involved in the lab’s day-to-day operations. “Historically, accurate DNA testing to establish paternity has been out of reach for most of the population. When I started this lab, my goal was always to be able to hold it to the standards of the best international institutions. I saw a real need for DNA testing that could be trusted.”

Today, most labs in the Dominican Republic still charge upwards of $500 to send DNA samples to U.S.-based operations. In addition to the exorbitant cost—which few Dominicans can afford—many hands are involved in the chain of custody of the samples.

In the 1990s, Patria’s daughter Vilma Diaz followed in her mother’s footsteps. After graduating from college in Santo Domingo and doing post-graduate work at Spanin’s Santiago de Compostela University, Vilma joined the staff of the lab full-time and became its president. She shared her mother’s devotion to accuracy—even more so after the O.J. Simpson trial.

A Simpson Lesson

DSC_0156_resizedDuring the 1995 trial of O.J. Simpson the defense argued that lab procedures had so thoroughly contaminated the blood evidence collected at the crime scene that any DNA analysis of the blood would be unreliable. Extremely serious patterns of contamination in the Los Angeles Police Department’s PCR (polymerase chain reaction) analysis were found in other tests. A few years later, Vilma heard about this first-hand during a training with one of the DNA experts who testified for the Simpson defense.

“I walked away from that training in awe of the power of lab results,” says Vilma. “We decided then and there that we would pursue full accreditation and not just meet quality control expectations, but strive to exceed.”

Around the same time, Dr. Blanca Odette García, a professor at the Universidad Autonoma de Santo Domingo (Autonomous University of Santo Domingo—UASD) was named director of accreditation and certification and worked closely with Patria and Vilma to ensure the lab met the requirements for ISO 9001:2000, an internationally recognized quality standard.  While the lab was pursuing these accreditations, Vilma heard about a company in Westbrook, Maine that manufactured a system for pipette calibration—one of the most crucial elements in ensuring accurate test results—that was not subject to the errors common to the traditional gravimetric method.

Like most labs in the Dominican Republic, Patria Rivas Laboratory would regularly ship its pipettes to the U.S. for calibration. The lab would sometimes opt to discard and replace pipettes exhibiting questionable performance, instead of dealing with the time constraints of shipping critical-use instrumentation to another country. Both options were costly and time consuming, so Vilma contacted Artel to find out more about the company’s PCS Pipette Calibration System.

Artel Lands in Santo Domingo

The Artel PCS is a compact, bench-top system which uses photometry to make fast, NIST-traceable measurements – in a working lab environment- of pipette delivery volumes, from as low as 100 nL to 5000 µL. The system features an easy-to-use screen-based interface that guides the user through the calibration process. In 2008, Artel’s PCS Product Manager, Dr. Bjoern Carle, arrived in Santo Domingo to install the PCS at the Patria Rivas Laboratory and conduct on-site training—helping staff with pipetting technique (a skill universal to laboratories) as well as use of the Artel system.

“Both Patria and Vilma really understood the importance of accurate results,” says Dr. Carle. “They’re running a world-class lab—for them it’s almost a matter of national pride to be able to show that their quality standards often surpass accreditation requirements.”

Since liquid transfers by pipettes are such common laboratory tasks, the critical importance of these steps towards the quality of a final test result is often overlooked, regardless of lab location. For instance, in January 2007, the Food and Drug Administration (FDA) sent out approximately 1,000 letters to various labs in the U.S. regarding the lack of reproducibility in assays.  The lack of accurate and precise pipetting results is a common cause for such deficiencies in assay reproducibility. Patria Rivas’ investment in the Artel PCS enabled the lab to take control of its results—a key ingredient not just in achieving its accreditation goals, but in maintaining its hard-earned reputation as a trustworthy lab.

These days, the PCS has a room of its own at the Patria Rivas Clinical Laboratory—the Calibration Office. Since acquiring the system, the lab has also achieved ISO 9001 certification from AENOR (Spanish Association of Standards and Certifications) and IQNet (International Certification Network), in addition to its AABB accreditation.

Used in conjunction with the Artel Pipette Tracker pipette management software, the PCS automates data collection during calibrations, facilitates calibration scheduling, and generates reports for regulatory compliance. The Pipette Tracker software minimizes manual data entry and eliminates the risk of transcription errors because results are automatically logged in a database.

“The PCS has helped us to become more efficient without sacrificing the high standard of quality control and accuracy we hold our lab to,” says Vilma. “The accreditations we’ve received are a testament to the development of the scientific community in this country. My hope is that we can set an example for other labs in the Dominican Republic and beyond—first world standards are not unattainable.”