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This article reports on a survey of medical laboratorians' knowledge of quality systems in their workplace and their perceptions about the effect of job function, education and training, professional credentials, and experience on the overall quality of testing and results.
The Medical Laboratory Workforce Survey was designed and conducted in Vermont in 2005. Surveys were distributed to all laboratorians working in Clinical Laboratory Improvement Amendments-regulated laboratories throughout Vermont. Results were analyzed for statistical significance using the Fisher's exact test for overall group comparisons.
Laboratorians perceived that they were generally knowledgeable about the quality systems in place in their laboratories (96% considered themselves familiar with quality assurance [QA] measures in their laboratory), but meeting quality objectives and perceptions of factors that impact quality measures in the laboratory were variably influenced by the laboratorians' years of experience, professional credentials, organization type, and job title. Almost half (47%) of laboratorians said they did not have a role in deciding the QA measures, whereas 77% felt they had a significant impact on meeting the QA objectives.
Not all laboratorians feel that they play a significant role in assuring quality or influencing quality measures used in the laboratory. All laboratorians should be encouraged to take an active approach to influence quality systems in the laboratory to ensure the highest quality health care possible.
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 analytical,4–10 and postanalytical3 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.
The 2005 Medical Laboratory Workforce Survey was constructed using the CLSI quality guidelines as the primary guide for question development. In addition to querying laboratorians about their knowledge and perceptions of quality systems, the survey also garnered important demographic data regarding the status of the medical laboratory workforce in Vermont.19 Participants answered questions that were designed to inquire about their knowledge of quality systems, specifically as they pertain to CLSI document GP26-A3, “Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition.”20 For the purpose of this survey, QA measures are defined as those activities that are necessary for an organization to meet its quality objectives. These measures are often part of a quality system or plan. QA measures may include QA procedures, standards, and guidelines in place in a laboratory. Two individuals (one from CLSI and a second who is credentialed as a quality systems manger by the American Society for Quality) reviewed the survey for validity. The survey was also piloted among laboratorians in an academic medical center laboratory in a neighboring state, and the study was approved by the University of Vermont Institutional Review Board.
Because there is no licensure of medical laboratorians in Vermont, it was not possible to identify all practicing medical laboratorians. It was first necessary to identify all laboratories that came under CLIA regulations and ask the laboratory directors to identify all laboratorians who were performing either moderate- or high-complexity testing (under the CLIA definitions) at their laboratory. The laboratory directors, in turn, distributed the surveys to all identified laboratorians, and their supervisors or laboratory managers, under their charge. Surveys were voluntarily completed and returned anonymously to the University of Vermont. The survey was distributed in March 2005 to 474 laboratorians employed in Vermont.
We used the Fisher's exact test for the overall group comparisons. If significant, we examined cell Chi-square statistics. We adjusted the alpha for two pairwise comparisons (percent agreed and percent don't know); the χ2 was, therefore, considered significant only if >5.024 (p≤0.02).
There were 235 survey respondents for a 50% response rate. Of the respondents, 52 (22%) identified themselves as working in an academic medical center. Seventy-nine percent had an MLT or MT credential; the remaining respondents were not credentialed. The majority had a bachelor's degree (n=140, 60%). Additionally, the data revealed an experienced laboratory workforce: 56 (24%) had fewer than 10 years of experience, 48 (20%) had worked 11 to 20 years, and 130 (55%) had more than 20 years of experience (Table).
Generally, respondents agreed that their laboratory had a full range of QA measures (94%), had oriented staff in QA measures (85%), used QA measures based on federal regulations (95%), and had additional higher standards (88%), as well as guidance by the parent organization (74%). There were a few significant group differences. Laboratorians with MLT credentials responded differently than their colleagues to the statement, “My laboratory has QA measures based on higher performance standards of national or international organizations” (Figure 1A, p=0.03). Significant differences were seen when comparing responses to the same statement by laboratorians' years of professional experience (Figure 1B), with those having fewer than 10 years of experience being less likely to agree (χ2=5.67, p=0.02), compared with their more experienced colleagues.
The type of organization also had a significant impact on whether laboratorians were subject to higher than minimal QA standards (established for the purpose of this survey as those required by CLIA 1988), as respondents from organizations other than academic medical center laboratories or community hospital laboratories were more likely to disagree (Figure 1C, χ2=7.79, p=0.01). Additionally, bench laboratorians were less likely than supervisors to know that their laboratory had QA measures guided by the quality system of the parent organization (Figure 2, χ2=5.21, p=0.02).
Respondents had some negative perceptions about whether several different factors have an impact on meeting QA objectives. One-quarter to one-third of respondents felt neither education level (27%), experience (25%), nor credentials (38%) had a significant impact. Not too surprisingly, there were significant group differences: 80% of those holding the MT credential, compared with 56% of the other laboratorians, perceived level of education as having an impact on meeting QA objectives (Figure 3, p<0.001). Forty-five percent of laboratorians with fewer than 10 years of experience, compared with 19% of more experienced laboratorians, disagreed that laboratorians' number of years of experience had an impact on meeting QA objectives (Figure 4, χ2=8.38, p=0.004). Non-certified laboratorians were more likely than those who were certified to respond “don't know” to the impact of having a credential (Figure 5, χ2=5.02, p=0.02).
Nearly three-fourths of respondents agreed that vacancy (72%) and turnover rate (74%) had an impact on meeting QA standards. Additionally, MLT-credentialed professionals had a different pattern of responses (p=0.03) to the question about the impact of turnover rates (Figure 6).
While a large majority of laboratorians (96%) considered themselves familiar with the QA measures in their laboratory, nearly half (47%) of the respondents said they did not have a role in deciding the QA measures; however, the majority (77%) agreed that they had a significant impact on meeting the QA objectives. Experience was associated with the perception of being involved in the QA process (Figure 7A, p=0.001), as was organization setting (Figure 7B): 78% of laboratorians who worked in organizations that were neither academic medical center laboratories nor community hospital laboratories agreed that they were directly involved in deciding the QA measures used in the laboratory vs. 45% of their counterparts (χ2=6.28, p=0.01). Additionally, 80% of supervisors (Figure 7C) were personally involved in deciding the QA measures, compared with 42% of all others (χ2=9.40, p=0.002). Supervisors were also most likely to feel they had a significant impact on meeting the QA objectives of the laboratory, as only 5% disagreed, compared with 22% of all other laboratorians (Figure 8, χ2=5.00, p=0.02).
Finally, while the vast majority of respondents (92%) perceived that their supervisors were knowledgeable about clinical laboratory practice, the percentage of respondents that replied “don't know” was significantly higher among respondents from “other” organizations (7%), compared with respondents from either academic medical center laboratories or community hospital laboratories (0.5%, Figure 9, χ2=6.72, p=0.01).
We conducted this study to assess the perceptions and knowledge of clinical laboratory professionals in Vermont regarding QA systems in the clinical laboratory. This was the first survey of its kind in Vermont, querying clinical laboratory professionals about their knowledge of QA measures in the laboratory and perceptions of how different variables impact those quality measures. A surprising demographic finding was the level of experience (the majority had more than 20 years) in this statewide sample.
It is interesting to note that education level did not have any impact on either the knowledge or perception of QA measures in the clinical laboratory. However, laboratorians holding the MT credential (the credential associated with higher education levels) were more likely to agree that education level, professional credential, and turnover rates were factors that significantly impacted the laboratory's ability to meet QA objectives. These perceptions may be a function of selective perception/self-reinforcement or may be based in fact. This warrants further investigation.
It is important to report that the vast majority of all respondents agreed that their laboratory had a full range of QA measures, which are part of a comprehensive quality plan (94%) and were based on federal (CLIA) regulations (95%). Further, 96% of respondents agreed that they were familiar with the QA measures used in their laboratory. Interestingly, even though most laboratorians responded positively, 51% felt they were not involved in deciding the QA measures used in the laboratory, and more than 20% either disagreed or did not know if they personally had a significant impact on meeting the QA objectives of the laboratory. This disconnect is of concern because if laboratorians performing the actual tests on patient samples are not involved in the decision-making process regarding QA measures on the tests in which they are expert, or if one in five laboratorians doesn't feel they are part of meeting the QA measures in the laboratory, this could possibly lead to indifference in testing and a feeling of not being fully vested in their profession.
This study was undertaken in a small, predominantly rural state, having only one academic medical center. The results of similar studies in states having different demographic profiles may be different. However, the survey itself provides a tool that may be used to analyze quality and perceptions of quality by clinical laboratory professionals in areas outside of Vermont. Additionally, care must be taken when interpreting data regarding comparisons of laboratorians having different job titles. The categories of job titles compared were supervisor, bench laboratorian, or other. The category of “other” had a small population of respondents (n=11); therefore, these analyses should be interpreted cautiously. Additionally, there may be bias because only 50% of laboratorians responded. It is possible that nonrespondents may have lower investment in QA.
Laboratorians were generally knowledgeable about the quality measures in place in their laboratories. However, differences in perception of quality in the laboratory were noted, based on years of experience, professional credentials, job title, and the type of organization in which they work. It is disturbing that not all laboratorians perceive that they play a significant role in determining quality measures or are involved in assuring quality in the laboratory. All laboratorians, regardless of education, credentials, years of experience, organizational setting, or job position, should take an active role in both assuring laboratory quality and determining appropriate quality measures. This may need to be reinforced in the education and/or training processes for all laboratorians.
The survey used in this study provides a tool to understand laboratorians' perceptions of existing quality systems and quality measures, as well as uncover perceptions of factors that affect quality in the laboratory. The survey, either in its present or modified form, could be administered more broadly to assess the degree to which quality systems have been implemented in clinical laboratories. Certainly, this information can be used to provide direction when implementing laboratory quality training or in the development of new policies and procedures designed to improve the quality of health care provided by clinical laboratories and positively impact public health on the statewide level. It also provides a baseline from which subsequent studies can be performed and compared, and it will allow the tracking of trends and changes that may influence the quality of laboratory testing.
This work was supported in part by a grant from the U.S. Department of Health and Human Services, Health Resources and Services Administration (HRSA) (HRSA grant #1R1CRH03426-01-0), and from a grant from the College of Nursing and Health Sciences, University of Vermont. The authors thank Robert Ross, PhD, for help in developing the survey and Colleen Thomas, MS, for assistance with the data analysis.