12/1/2012 7:00 AM
By Ann Wilmer Delaware Correspondent
Maryland Department of Agriculture’s Animal Health Diagnostic Laboratories in Salisbury and Frederick are among the first in the U.S. to secure accreditation for meeting international standards for specific infectious disease tests.
The accreditation was awarded by the American Association for Laboratory Accreditation (A2LA), a nonprofit international laboratory accreditation organization.
“Three years ago, we told our animal health staff that we wanted these labs to be A2LA accredited,” said Agriculture Secretary Buddy Hance. “We already knew they were doing a high quality job, but we wanted to be able to document it according to standard international practices so there would be no question.”
To qualify for accreditation, the two laboratories had to demonstrate through detailed documentation that they adhere to strict internationally recognized standards and protocols when conducting the accredited tests. The standard is: International Organization for Standardization (ISO) 17025:2005 and the World Organization for Animal Health (OIE) Quality Standard and Guidelines for Veterinary Laboratories: Infectious Diseases, 2008.
An ISO standard is a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. The World Organization for Animal Health is part of the United Nations. ISO/OIE standards are related to animal health and veterinary laboratory requirements.
MDA’s animal health labs have long been accredited by the USDA.
Dr. Tom Jacobs, assistant state veterinarian, said that while USDA standards are rigorous, the standards and guidelines required for an OIE certification are even more stringent and far reaching.
“If USDA is the silver standard then this is the gold standard,” he said.
It took three years for the staff and management of the animal health labs to document their quality management system in accordance with international standards. Jacobs said the process began with a two-day training program that involved everyone from Maryland Deputy Secretary of Agriculture Mary Ellen Setting to the lab technicians who actually perform the diagnostic tests under the supervision of scientists at the lab.
The lab in Frederick also screens for avian influenza but focuses primarily on horses and food-producing livestock, receiving its accreditation for contagious equine metritis (CEM) isolation and identification
The Salisbury lab specializes in testing for avian influenza as well as salmonella. Shore residents will recall that it was the outbreak of avian influenza several years ago that resulted in restrictions of visitors to poultry farms and extra precautions being taken when authorized visitors went from one farm to another for fear of spreading the disease. Destroying diseased birds was an expensive, but necessary, precaution with a severe economic impact in some parts of Maryland and Delaware.
“Anyone in a poultry-growing area recalls the avian influenza scare a few years back,” said Julie Oberg, MDA media spokesperson. “The threat is always out there and that’s why we do these tests. It’s proactive, intended to prevent disease. As poultry exports become more important to the industry, accreditation that meets international standards is critical.”
Poultry is the largest agricultural sector in Maryland, accounting for 40 percent of all farm receipts, Hance said. The animal health laboratories conduct two critically important functions for this industry: surveillance testing for avian Influenza for poultry flocks before processing and testing environmental samples for salmonella to comply with federal regulations.
In 2011, MDA laboratories conducted 11,579 tests for avian influenza, the vast majority being pre-slaughter testing of healthy birds.
A seal of approval from the American Association for Laboratory Accreditation attests that an organization follows a documented quality management system that meets international standards for everything from the calibration of machinery to technical competency for conducting accredited tests.
In a prepared statement, Maryland Gov. Martin O’Malley said that taking steps to obtain A2LA accreditation indicates how sophisticated and forward thinking Maryland’s agriculture industry has become.
Both labs were already approved to conduct numerous tests by the USDA’s National Veterinary Services Laboratories (NVSL) as part of the National Animal Health Laboratory Network, including avian influenza, salmonella and CEM -- federally designated as “national diseases of concern.” All laboratory scientists and technicians have been required to pass annual proficiency tests conducted by NVSL, which are also pre-requisites for achieving ISO-OIE laboratory accreditation. The laboratories can also provide back-up services for USDA and other states if there is a disease outbreak.
The new ISO-OIE accreditation, however, requires much more comprehensive, detailed documentation of every facet of laboratory testing - from how often staff members are trained to how samples are collected, handled, transported, processed, tested and disposed. Laboratory equipment must be maintained and calibrated on set schedules to ensure it is working properly.
Even processes that have no direct impact on the lab tests - such as how supplies are ordered and received - must be carefully documented to ensure that the best laboratory practices are being adhered to, as defined and required by the international standard. All documents must be retained for five years.
“We know we do a good job. Now the rest of the world knows we do a good job,” said Dr. Claudia Osorio, director of the Salisbury Animal Health Lab. “Our diagnostics are done in the right environment and everything is being checked. Even our equipment is being calibrated according to a specific calibration method. It holds us accountable to a higher recognized laboratory standard. It is all about documented quality control.”
Both laboratories also serve as basic sentinel clinical laboratories for the Maryland Department of Health and Mental Hygiene. Sentinel clinical laboratories are capable of analyzing or referring specimens that may contain microbial agents or biological toxins of serious public health consequence.
MDA plans to expand the panel of diagnostic tests covered by accreditation.
“Accreditation is a journey, not a destination,” said Dr. Guy Hohenhaus, state veterinarian with agency oversight of the animal health laboratory system. “Inherent in accreditation is the commitment to maintain and improve quality management systems over the long term.”
Several additional tests are being considered for inclusion in the 2013 audit.