Medical laboratorians, including clinical laboratory scientists (medical technologists [MTs]) and clinical laboratory technicians (medical laboratory technicians [MLTs]), fill a critical role in meeting both health-care and public health needs by providing testing results and information that assist with diagnosing and treating various medical conditions. In 2006, according to the U.S. Department of Labor, Bureau of Labor Statistics, there were approximately 167,000 MTs and 151,000 MLTs nationally.1
These medical laboratorians perform many different tests of varying complexities using a variety of technologies. The quality of testing and results obtained by laboratorians has a tremendous impact on patient treatment and outcomes, as errors in testing can have a disastrous impact on patient health. Errors occur at higher-than-desirable rates in each of the preanalytical,2,3
phases of testing, and these errors occur despite the presence of quality control and quality assurance (QA) procedures.
It is critical for patient health that those who perform laboratory tests have a complete and thorough understanding of quality systems. There are currently multiple documents and standards that help guide laboratories' and laboratorians' work on quality control, QA, and quality management systems. Organizations such as the International Organization on Standardization,11
the Clinical and Laboratory Standards Institute (CLSI, formerly the National Committee on Clinical Laboratory Standards),12
and the College of American Pathologists13
are well-known organizations that establish guidelines and standards for laboratory quality. In addition, each laboratory often has in place its own set of internally generated standards, policies, and procedures that it follows with regard to laboratory quality.
Prior to 1967, laboratory quality standards were either state specific or voluntary. The passing of the Clinical Laboratory Improvement Amendments of 1967 (CLIA 1967) improved this by providing new standards for clinical laboratory testing; however, it did not address testing outside of laboratories, such as testing performed in doctors' offices. It also left gaps with respect to testing consistency among different sites and proficiency testing. In the 1980s, laboratory errors involving Papanicolaou-smear testing were exposed in the news media14
and provided an impetus for the enactment of CLIA 1988, which addressed and improved many of the quality and testing-related inadequacies of CLIA 1967.15,16
Since then, other standards and policies, such as those from CLSI, the International Organization on Standardization, and the College of American Pathologists, have been developed and may be in place.
In 1988, the Institute of Medicine established three core functions for public health: assessment, policy development, and assurance.17
If one acknowledges that quality laboratory practices are an essential component of both the health-care and public health systems within the United States, then it is reasonable to apply the three functions to a statewide laboratory system. This study attempts to measure the “assurance” aspects of laboratory quality as seen by those who work daily in medical laboratories throughout Vermont.
In Vermont clinical laboratories, laboratory professionals work in different organizational settings, have different levels of educational and professional credentials, possess a range of professional experience, and have different levels of on-the-job responsibilities. These laboratory professionals are predominantly baccalaureate educated and professionally credentialed.18
Historically, there has been no standardized tool used to gauge or track the status of the medical laboratory profession.
We report the results of a survey conducted in 2005, which investigated the knowledge and perceptions of quality systems by medical laboratorians in Vermont. We hypothesized that there are sufficient quality systems guidelines, which have been promulgated by the CLSI to ensure accuracy, reliability, and safety in laboratory testing. However, many laboratory professionals may not be well trained in or are not aware of existing quality standards. This could potentially lead to substandard levels of proficiency and, ultimately, inferior testing quality and outcomes. Further, this variability in quality systems knowledge and perceptions may be attributable, at least in part, to the hypothesized variables—namely, education level, job responsibilities, professional credentials, experience of the laboratorian, and type of organization in which the laboratorian works. We examine the awareness, knowledge level, and perceptions of existing quality control, QA, and quality management systems by laboratory professionals in Vermont. We also provide a baseline from which subsequent studies can be performed and compared. Future evaluations will allow researchers to track trends and changes that may influence the quality of laboratory testing.