Quality Management in the Clinical Microbiology Laboratory

Introduction and History of Quality Management

The objective of this paper is to define quality in the clinical microbiology laboratory, including its major components. Toward this end, it examines what constitutes quality in the laboratory setting and discusses the activities designed to assure quality from specimen collection through result reporting.

Quality management in clinical microbiology was initiated in the 1960s when government bodies and professional societies introduced proficiency testing and laboratory inspection and accreditation programs. There were many laboratory scientists and pathologists "independently active and creative in expanding efforts to monitor and improve practices" (Bartlett et al., 1994, p. 1). The initial emphasis was on intralaboratory processes, with attention later shifting to "physician ordering, specimen collection, reporting, and use of information" (Bartlett et al., 1994, p. 1).

Quality management in the laboratory is in part dependent on indicators that demonstrate how laboratory resources are being utilized and how that utilization benefits patient care. As Bartlett et al. (1994) state, "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" (p. 1). Effective training and ongoing education do more to ensure quality and prevent errors than surveillance alone (Bartlett et al., 1994).

The introduction of Medicare and Medicaid prompted government efforts to regulate healthcare costs and ensure quality. To prevent financial abuse and ensure high-quality laboratory results, the U.S. Congress passed the federal Clinical Laboratory Improvement Act (CLIA 67) in 1967. The Centers for Medicare and Medicaid Services — formerly operating under the original CLIA framework — were created "as part of the Department of Health and Human Services to oversee the enforcement of the CLIA 67 regulations as well as to oversee the Medicare and Medicaid programs" (Sharp and Elder, 2004, p. 1).

The microbiology laboratory must maintain Standard Operating Procedures (SOPs) for the following reasons:

Background and Standard Operating Procedures

(1) To improve and maintain the quality of laboratory service to patients and to 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.

(3) To help avoid shortcuts 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). Each SOP must be assigned a title and identification number and must be signed and dated by an authorized individual. The SOPs must provide a description and appropriate use of microbial investigations, as well as guidance on 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 factors may impact the accuracy of results (Arora, 2004).

CLIA 67 required hospitals and clinical laboratories to adhere to "strict quality control, proficiency testing, test performance, and personnel standards" (Sharp and Elder, 2004, p. 1). Every testing facility was required to hold a certificate and was subject to a compliance inspection on an annual basis. CLIA 67 affected laboratories engaged in interstate commerce and covered approximately 12,000 laboratories — primarily commercial and hospital laboratories — leaving laboratories in physicians' offices and other small healthcare facilities largely unregulated. Before 1988, less than 10% of all clinical laboratories were subject to government requirements for minimum quality standards, meaning a substantial proportion of patient testing occurred in facilities operating below those minimum thresholds.

CLIA 67 and CLIA 88 Regulatory Framework

The passage of the Clinical Laboratory Improvement Amendments of 1988 was driven in large part by media concern over the quality of cytology testing services, particularly Pap smears. The Wall Street Journal published articles in the 1980s reporting that women had died from uterine and ovarian cancer due to the misreading of Pap smear tests, while also exposing so-called "Pap mills" and questioning overall laboratory quality (Sharp and Elder, 2004).

The CLIA 88 regulation "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). CLIA identified employee training and competency as a primary component of ensuring high-quality test results and established requirements for the performance and documentation of personnel training along with ongoing competency testing.

Six areas identified by CLIA for laboratory assessment of competency include:

(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 instrument maintenance and function checks;

(5) Assessment of test performance through 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)