Introduction
The PEER Committee approved a preliminary investigation into operations of the Board of Animal Health's Veterinary Diagnostic Laboratory after receiving correspondence from a legislator expressing concern, based upon specific allegations of laboratory errors, that lab services have deteriorated to unacceptable levels. After determining the validity of these allegations, PEER sought to determine if quality assurance controls were adequate to ensure clinical laboratory operations which would reduce the chance of such errors occurring.
MISS. CODE ANN. Section 69-15-11 (1972) requires the Board of Animal Health to "maintain a complete and adequate diagnostic clinic at Jackson capable of rendering quick and accurate diagnoses of disease conditions of animals and livestock, including but not limited to cattle, horses, sheep, swine, poultry and pets."
Overview
The state's animal health interests include meeting farmers' economic need for healthy livestock, flocks, and ponds, as well as addressing animal health concerns of veterinarians and the animal owners they serve. These animal health interests are placed at risk if the Board of Animal Health or its Veterinary Diagnostic Laboratory fails to ensure quality in the lab's diagnostic testing.
In reviewing a series of allegations about problems at the Veterinary Diagnostic Laboratory, PEER verified several cases in which serious laboratory errors had occurred. Further review revealed that the lab has not established the systems needed to ensure proper testing and to check the accuracy of its results, particularly in the facility's chemistry and microbiology laboratories. This lack of quality assurance controls has compromised the Board of Animal Health's ability to address the state's animal health interests.
The work of a diagnostic laboratory entails exercise of professional judgment in selection of tests to be run, testing agents to be used, and interpretation of results. To ensure that rigorous science is taking place, a lab must establish systems to address those scientific concerns. A lab's technical personnel should develop policies specifying conditions under which control tests should be run, if samples should be split to obtain second opinions, if further testing should be conducted, and if the advice of other diagnosticians should be sought. Because the Veterinary Diagnostic Laboratory has not established a comprehensive system for ensuring the accuracy of its results, errors are less likely to be detected and corrected than would be the case if a full system of controls were in place.
The lab's recent involvement in testing related to the quality of food for human consumption has substantially increased the risk associated with errors and problems in judgment. The lab has no specific authority to conduct food-related tests and has not developed the strict quality assurance systems needed to ensure accuracy in food-related testing. Several of the errors PEER confirmed during this review occurred in the lab's food-related testing programs. Legislation enacted during the 1998 session specifically prohibits the lab from conducting food-related tests in the future. The same legislation places the lab under a newly created Veterinary Diagnostic Laboratory Board composed of individuals with technical expertise in clinical operations.
The Veterinary Diagnostic Laboratory is accredited by the American Association of Veterinary Diagnostic Laboratories and it employs many highly qualified professionals, but in order to remain an important resource for farmers and veterinarians, the Veterinary Diagnostic Laboratory must consistently provide accurate, well-documented results. The seriousness of the lab's quality control deficiencies calls for immediate intervention by its newly created board to establish systems for preventing and detecting errors that could negatively impact animal health.
Errors Identified in Allegations and Confirmed by PEER
PEER identified errors in the Veterinary Diagnostic Laboratory's work affecting animal health, as well as errors with implications for the quality of food for human consumption.
Prior to initiating fieldwork for this review, PEER received several allegations involving falsified test results, misdiagnoses, and improper testing procedures at the laboratory. Subsequent fieldwork substantiated these allegations. Such errors indicate that the Veterinary Diagnostic Laboratory cannot ensure proper clinical operations which would fulfill the laboratory's statutory mission of rendering quick and accurate diagnoses of disease conditions of animals.
° PEER noted laboratory errors that were potentially costly to farmers and misleading to veterinarians.In order to render "quick and accurate diagnoses of disease conditions," laboratory personnel are charged with running the appropriate tests on samples and analyzing results to provide diagnoses to local veterinarians, county agents, or livestock owners.
As exemplified by the cases below, lab operations currently do not ensure accuracy. PEER found cases of falsified test results, misdiagnoses, and improper testing procedures, including the following.
-- A lab chemist failed to run a test needed to evaluate the health status of a dog and entered into the record the results of a test that he had conducted several days earlier on a different dog.
-- Although other Veterinary Diagnostic Laboratory tests strongly suggested copper toxicity in a lamb, a chemist conducting a copper analysis of tissues from the same animal did not question his test's negative results nor did he check his results to resolve the apparent contradiction.
° PEER noted laboratory errors with human-health implications.The Board of Animal Health exceeded its statutory mission by assuming food-related testing operations when it began conducting antibiotic residue and E. coli testing in the spring of 1997 for the Department of Agriculture and Commerce's Meat Inspection Program. The board's staff assumed these operations without developing operating procedures to govern such, which contributed to the errors noted below.
-- The lab's chief microbiologist directed laboratory staff to utilize the wrong size control disc in antibiotic residue testing, which caused test results to be inconclusive.
-- The lab's chief microbiologist required lab personnel to conduct E. coli testing on samples believed to be adulterated with chlorine, which invalidated the E. coli test results, violated federal Food Safety and Inspection Services principles, and could have created a public health risk.
-- The Board of Animal Health's Lab Director required a veterinarian to sign poultry health certificates without conducting the appropriate poultry examinations for such certificates, which violates American Veterinary Medical Association policies.
Major Quality Control Problems in Animal-Health-Related Testing and in Food-Related Testing
By failing to establish control systems needed to ensure the technical quality of its testing, the lab has jeopardized the board's effectiveness in accomplishing its animal health mission, as well as the effectiveness of the state and federal governments in promoting human health.
PEER's preliminary fieldwork substantiated lab employees' allegations of falsified test results, misdiagnosis, and improper testing procedures. PEER reviewed the lab's quality assurance procedures and controls to determine whether they were adequate to ensure clinical operations which would prevent and detect errors such as those PEER verified. The absence of such controls demonstrates the potential for other errors to occur without detection.
° The chemistry lab has failed to implement experimental controls which would help ensure the accuracy and integrity of chemistry testing.Lab personnel should run a control standard to verify or regulate a scientific experiment by conducting a parallel experiment or by comparing with some other standard. The Veterinary Diagnostic Laboratory did not establish a policy in its chemistry lab that controls be run on all tests until January 1998.
° The risks associated with the Veterinary Diagnostic Laboratory's failure to establish an effective quality control system were heightened in June 1997 when the microbiology lab began conducting food-related tests. However, the microbiology lab did not establish quality control procedures to ensure the accuracy and integrity of new testing associated with the processing of food for human consumption.When the microbiology lab assumed food-related testing in 1997 for the Meat Inspection Program, the lab's managers did not develop standard operating procedures and quality control procedures for antibiotic residue testing, not did they develop quality control procedures for E. coli testing.
Recommendations1. The Lab Director of the Veterinary Diagnostic Laboratory should implement the American Association of Veterinary Laboratory Diagnosticians' recommendation that the lab appoint a quality control coordinator. The Lab Director should also establish a quality control committee, to be chaired by this quality control coordinator, comprised of one representative from each of the seven specialty labs, to develop, implement, and annually review quality assurance and control procedures of the Veterinary Diagnostic Laboratory. Such control procedures should be approved by the Lab Director and by the Veterinary Diagnostic Laboratory Board, which was established by House Bill 1584.
2. The Board of Animal Health should comply with MISS. CODE ANN. Section 5-11-1 et seq. (1972) in its transfer of resources to the Veterinary Diagnostic Laboratory Board on July 1, 1998, as provided for in House Bill 1584, 1998 Regular Session. MISS. CODE ANN. Section 5-11-1 et seq. (1972) provides for a transition authority to develop plans to facilitate the transfer of an agency's duties and responsibilities to another agency.
3. The Veterinary Diagnostic Laboratory Board, Lab Director, and Quality Control Committee should adopt proper quality assurance controls before the Veterinary Diagnostic Laboratory initiates any new testing procedures. Further, the Lab Director should insure the proper training of Veterinary Diagnostic Laboratory personnel in new clinical procedures prior to the lab offering such procedures to its clients.
4. The Lab Director should not require any Veterinary Diagnostic Laboratory personnel to certify the clinical health of any animal which has not been examined by that person. The Lab Director should propose revisions in "Mississippi's Disease Reporting Procedures" relevant to flock health certificates to the United States Department of Agriculture's Area Veterinarian in Charge.
5. The Veterinary Diagnostic Lab, as well as any other clinical lab in the state, should not conduct testing on samples believed to be adulterated. Rather, the lab should require the submission of other samples from the submitting authority.
6. In compliance with House Bill 1584, the Veterinary Diagnostic Laboratory should not conduct any regulatory testing for food purposes.
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