Does proficiency testing meet its objective

The objectives of proficiency testing are to determine the appropriateness of procedural protocols, to evaluate the laboratory personnel’s ability to perform these analyses satisfactorily, and to ensure that the results generated by any laboratory are correct and that the analyses are relevant to the clinical situation (6, 7). These objectives are endorsed by every responsible laboratory scientist who strives to obtain accurate, meaningful results as rapidly and as cost-effectively as technology permits. In microbiology, proficiency testing measures the competence of staff and the use of procedures applied and performed to recognize the causative agent(s) of an infectious process and, when indicated, to provide guidance for therapy. Proficiency testing advocates must remember that the measure of a laboratory is its ability to provide meaningful information for a physician treating a patient (1). This also must be the goal of proficiency testing; unfortunately, proficiency testing is not always successful in this respect. The design of proficiency test specimens must represent the reality encountered in the clinical laboratory. An appreciable number of specimens submitted for microbiological analysis originate from or near areas populated normally by a wide variety of microorganisms; sometimes the collection procedure cannot avoid the risk of contamination with exogenous organisms from usually contaminated areas. This situation is not commonly reflected in proficiency test samples. Often, the specimen allegedly emanating from a specific anatomic locus contains monomicrobic representatives of species not frequently encountered in such specimens. The directions accompanying the proficiency test demand identification to the species level and antimicrobic susceptibility testing on isolates from specimens that ordinarily might not be so treated in the routine of most laboratories since such information is not pertinent to the needs of the physician of record or for infection control. Indeed, correct identification to the species level or identification of unusual, not necessarily pathogenic isolates appears to be the goal of proficiency testing. However, in reality such efforts often do not reflect the needs of the clinician to treat the patient satisfactorily (2, 4). The inclusion of antimicrobic agents in the susceptibility screen apparently reflects the preferences of the testing agency, not those of the formulary of the medical facility. Also, reluctance of the test agencies to accommodate emerging methodologies to detect and identify organisms is detrimental to laboratories’ efforts to remain au courant. Testing agencies demand that proficiency test specimens be analyzed in the same manner as clinical specimens. No argument can be advanced against testing proficiency specimens in this fashion. However, the dire consequence of failure, namely, loss of license, puts an entirely different facade on proficiency specimens. The laboratory’s failure to reach the same consensus as that of the reference laboratories does not necessarily reflect on the quality of the testee laboratory. Variables such as the quality of the specimen, transportation, environmental conditions, and human error can all impact on the laboratory’s efforts to perform at an acceptable level. But, more importantly for the goal of proficiency testing, the extraordinary efforts to reach an accurate result on the part of the laboratory staff are understandable but defeat the purpose of the proficiency tests. As quoted by Mason (3), the National Council of Health Laboratory Services (5) recognized these potentially adverse effects and stated, “Emphasis on proficiency testing tends to encourage conformity to poor but widely used methods and it promotes cheating and other methods to obtain the correct value.” Rather than the draconian measure of potential loss of license, an investigation by the agency in concert with the laboratory is a more constructive approach, especially if the laboratory’s previous performances have been unassailable. Another troublesome and important aspect of the problem is the presence of several agencies demanding that medical facilities eager to be certified or to comply with the governmental dicta participate in each of several programs at considerable cost for the privilege to participate in the testing program. For example, state or municipal health departments and the College of American Pathologists leave directors and administrators no choice. Laboratories must duplicate the proficiency efforts to no advantage but the financial gain of each of these agencies. In addition to the redundancy of agencies, each participating laboratory is burdened by rather frequent repetitious testing in each of the specialties in clinical microbiology. We cannot understand the rationale for monitoring laboratories with an established excellent performance record at least three times a year. No statistical evidence has been presented to support the need for this frequency; however, its concomitant adverse financial effect is apparent. Laboratory inspections are conducted by government or professional agencies intent on establishing compliance with the guidelines perceived by each organization as appropriate for minimal laboratory performance. There cannot be a disagreement with the concept that inspection is beneficial to ensure appropriate performance and interpretation of tests as well as adherence to laboratory protocols, including quality control, personnel qualifications, and required safety considerations. However, it is common for a laboratory to be subjected to inspection by several agencies, each of which has its own agenda, attitude, and fees. This needless duplication leads to confusion and waste of limited time and money in an already overburdened laboratory struggling to preserve rapidly diminishing resources. The charge of the clinical laboratory is to * Corresponding author. Mailing address: Long Island Jewish Medical Center, 270-05 76th Ave., New Hyde Park, NY 11040. Phone: (718) 470-7531. Fax: (718) 962-6410.