The objective of this study is to define quality in the microbiology clinical laboratory including its major components. Toward's this end, this study will examine what constitutes quality in the laboratory setting and will list and discuss the activities in the laboratory that are designed to assure quality from collection of specimen to reporting.
Quality management in the clinical microbiology field was initiated in the decade of the 1960s with government and professional societies alike introducing proficiency testing and laboratory inspection and accreditation programs. It is reported that there were many laboratory scientist and pathologists "independently active and creative in expanding efforts to monitor and improve practices." (Bartlett, et al., 1994, p.1) The emphasis in the beginning was on intralaboratory process with attention later shifting to such as "physician ordering, specimen collection, reporting, and use of information." (Bartlett, et al., 1994, p.1)
I. Quality Management
Quality management in the laboratory is in part dependent on indicators being monitored that demonstrate evidence of how laboratory resources are being utilized and how this utilization benefits care of patients. It is reported, "Continuous quality improvement should be introduced which consists of a more thorough assessment of doing the right things vs. The wrong things in terms of customer demand and satisfaction and studying the cumulative effect of error when responsibility is passed from one person to another." (Bartlett, et al., 1994, p.1) It is reported that effective training and ongoing education does more to ensure quality and prevent errors that surveillance is able to ensure. (Bartlett, et al., 1994, paraphrased)
It is reported that the introduction of Medicare and Medicaid resulted in government efforts to regulate costs as well as to ensure health care quality. In order to ensure that the system was not financially abused and that laboratory results were of high quality the U.S. Congress passed the federal Clinical Laboratory Improvement ACT (CLIA 67) in 1967 and the Centre for Medicare and Medicaid Services, formerly the federal Clinical Laboratory Improvement Act was created "…as part of the Department of Health and Human Services to oversee the enforcement of the CLIA 67 regulations as well as to verse the Medicare and Medicaid programs" (Sharp and Elder, 2004, p.1) The microbiology laboratory must have Standard Operating Procedures (SOPs) for the reasons stated as follows:
(1) To improve and maintain the quality of laboratory service to patients and identify problems associated with poor work performance.
(2) To provide laboratory staff with written instructions on how to perform tests consistently to an acceptable standard in the laboratory.
(3) To help avoid short-cuts being taken when performing tests.
(4) To provide written standardized techniques for use in the training of laboratory personnel.
(5) To facilitate the preparation of a list and inventory of essential reagents, chemicals and equipment.
(6) To promote safe laboratory practice. (Arora, 2004, p.1)
Arora (2004) reports that SOPs must be "written and implemented by a qualified experienced laboratory officer, and followed exactly by all members of staff." (p.1) In addition each SOP must be assigned a title and identification number and must be signed and dated by an authorized individual. The Standard Operating Procedures must provide a description and appropriate use of microbial investigations, as well as the proper filing of the request form, specimen collection and transport and checks upon the specimen and request form reaching the laboratory since all of these may impact the results accuracy." (p.1)
III. CLIA 67
A requirement of CLIA 67 was for only hospitals and clinical laboratories adherence to "strict quality control, proficiency testing, test performance, and personnel standards." (Sharp and Elder, 2004, p.1) Every testing facility was required to have a certificate and was subject to a compliance inspection on an annual basis. CLIA 67 impacted on those laboratories engaged in interstate commerce and covered somewhere around 12,000 laboratories which were primary commercial and hospital laboratories leaving laboratories in physicians' offices and other small health care facilities unregulated for the most part. Less than 10% of all clinical laboratories were under government requirements on meeting minimum standards of quality before 1988 with a great deal of patient testing performed in laboratories that were not under minimum quality standards. Driving the passage of the Clinical Laboratory Improvement Amendments of 1998 were media concern surrounding cytology testing service quality and most particularly related to Pap smears. (Sharp and Elder, 2004, paraphrased) The Wall Street Journal published articles in the 1980s that reported that women had died from uterine and ovarian cancer due to the misreading of Pap smear tests as well as exposing PAP mills and questioning laboratory quality generally. (Sharp and Elder, 2004, paraphrased)
IV. CLIA 88
The CLIA 88 regulation is reported to have "unified and replaced past standards with a single set of requirements that applied to all laboratory testing of human specimens." (Sharp and Elder, 2004, p.1) Standards for laboratory personnel including quality control (QC) and quality assurance "were established based on test complexity and potential harm to the patient." (Sharp and Elder, 2004, p.1) The CLIA identified employee training and competency as a primary component of ensuring test results of high quality and CLIA set out requirements relating to the performance and documentation of training of personnel along with competency testing that was ongoing.
V. Six Areas for Laboratory Assessment of Competency
Six areas identified by CLIA for laboratory assessment of competency include the following:
(1) Direct observation of routine patient test performance;
(2) Monitoring the recording and reporting of test results;
(3) review of intermediate test results; QC records, proficiency testing results and preventive maintenance records;
(4) Direct observation of performance of instrument maintenance and function checks
(5) assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and (6) Assessment of problem-solving skills. (Sharp and Elder, 2004, p.1)
VI. College of American Pathologists Study (1996)
The College of American Pathologists conducted a study in 1996 for measuring compliance with CLIA 88 regulations and measured employee competence assessment practices in departments of pathology and laboratory medicine. The study objectives were the measure of institutional competency assessment practices to measure the compliance of institutions to their own practices and to determine the specimen-processing personnel's competency. The study was comprised by three parts including a questions relating to current competency assessment practices, evaluation of compliance with the practices using personnel records, and a written appraisal of the competence of five institutions that participated in the CAP 1996 QProbes program. The results demonstrated as follows:
"89.2% of institutions had a written competency plan and that of those, 90.3% used their plan for microbiology. Approximately 98% of institutions reported reviewing employee competence at least annually; this consisted of direct observation in 87.5% of laboratories surveyed, review of test or QC results in 77.4%, review of instrument preventive maintenance in 60%, written testing in 52.2%, and other methods of assessment in 20.8%."
Conclusions of the study reported that "opportunities for improvement in employee competency assessments were numerous. Toward these improvements, the CAP provided several suggestions, which included the suggestion that direct observation can be used for assessing technical skills (as can patient and QC specimens), judgment and analytical decision-making processes, and teaching and training of personnel. (Sharp and Elder, 2004, p.1) Additionally noted by the CAP was that "…communication, judgment, and analytical decision making are essential skills that are rarely evaluated but that when they are evaluated, written testing should be used since interpretation of these skills using direct observation is highly subjective. In addition, the CAP recommended that laboratory employees who fail an assessment should not be allowed to perform these tasks if the competency assessment is a valid test of their skills, knowledge, and abilities." (Sharp and Elder, 2004, p.1) Finally, the CAP stated conclusions that written testing "was the one method of evaluation with the poorest compliance; thus, it did not recommend that written testing be used as an element of a competency assessment plan unless it can be performed consistently or is used as part of an assessment of communication and judgment skills." (Sharp and Elder, 2004, p.1)
VII. Code of Federal Regulations Requirements
Competency assessment in the clinical laboratory was mandated in U.S. law in 1988 as part of CLIA 88, is published in the Federal Register as part of the code of Federal Regulations (CFR) which sets out the requirements for initial training verification, initial competency assessment and ongoing competency assessment of laboratory personnel. The CFRs relating to competency assessment in the clinical laboratory are as follows[footnoteRef:1]: [1: As a brief explanation of the regulation titles, the number "42" indicates "Public Health," CFR stands for "Code of Federal Regulations," "493" indicates "Laboratory Requirements," and the numbers "1445" or "1451" are the section standards. These standards were enacted on 28 February 1992, amended on 19 January 1993, and revised on 1 October 2002. They can be accessed online at www.gpoaccess.giv/cfr/Index/html. Included below are the pertinent CFRs relating to competency assessments in the clinical laboratory.]…