The Effective Performance of the Microbiological Laboratories Worldwide - Essay Example

?A Comparison of Quality Assurance, Quality Control, and Continuous Quality Improvement as pertaining to the Microbiological laboratory. Standards for Quality assurance are an efficient way of maintaining the effective performance of diagnostic laboratories worldwide. And as in any discipline, it is necessary to upgrade these standards as advances become available. The quality of a laboratory test is generally considered to be synonymous with its accuracy and its precision. To be specific, these terms relate to how reliable the results are, and whether and how different outcomes can be reproduced. Often in microbiology, quality goes beyond technical perfection to take into consideration speed, the cost, and the how clinically useful or relevant the test is. Laboratory tests in general can prove exorbitant. As progress in medicine advances, they tend to use up an increasing proportion of the health budget. Quality concerns are becoming increasingly important in microbial, and various other diagnostic laboratories. But the simple term of Quality is no longer sufficient alone, and we must now develop mechanisms to assure customers, the general public and, of course, ourselves of the continuing quality of our service. Moving towards a quality-assured system is challenging, requiring an exacting attention to detail in all areas of a laboratory's working and organization. QUALITY ASSURANCE Quality Assurance is the systematized observation and monitoring to evaluate the various aspects of a project, service or facility including laboratories to maximize the probability that minimum quality standards are being met by multiple stages of the production process. QA cannot absolutely guarantee the production of perfect products. Systematized Microbiological investigations are critical in the treatment, diagnosis, monitoring/surveillance of infectious diseases and policies relevant to the selection and use of antimicrobial drugs. It is, of course, essential that laboratory results and reports are correctly interpreted through standards of both precision and accuracy. Challenges to these necessary objectives include the high cost of reagents and culture media, lack of reasoned, systematic approach to the selection and use of microbiological investigative techniques, and limitations in the procurement of trained technical staff and clinical microbiologists. For Quality Assurance to meet modern expectations of safety, precision, and professionalism, there must be a systemized approach at every aspect of the lab’s operations. Not only should stringent standards be the norm in terms of functional testing modalities; but the procedures must also influence the lab’s decision making process from step one. The World Health Organization provides Quality Assurance Guidelines for Specimen Collection and transportation; standards for personnel, the laboratory procedural manual, QC records and documentation, a referral process for specimens, patient reports where applicable, equipment standards, media standards, and external quality assessments. QA is more of a higher-level process-control operating at all stages; in laboratories of many disciplines. What is the process used to create the functional agents; the deliverables, or the laboratory results? This is Quality Assurance. It is external to the process itself in many cases. Other examples of Quality Assurance: Process Checklists Project Audits Methodology Standards Development Plans for integration of improvements Control of procedural errors in the laboratory Regular schedule of testing for equipment and culture media Documentation of media sources including lot numbers Documentation of sterilization procedures and pH measurements Documentation of preparation and expiration dates Documentation of positive and negative control testing Procedures for the inspection of damaged, commercial media or equipment Procedures and documentation for reagent storage Proper records and documentation of previous testing articles Results of the QC process Procedures for the reporting of out-of-control observations QC corrective actions taken Monthly QC records review Proper structure of procedural manuals Quality Assurance can be described temporally as well; QA regulates the diagnostic, creation process before the product is developed; the opposite being true for pure QC. The standards that ensure the right result, at the right time, on the right specimen, for the right patient. (Arora, 2003) In addition, an integral component of QA is the requirement that all laboratories maintain Standard Operating Procedures, or a bench manual. Thy must be written and implemented by a qualified laboratory officer and implemented by all staff members as faithfully as possible. Each specific procedure must be entitled and numerically referenced; and signed by at least one of the authors. SOP’s must determine appropriate use of reagents and equipment, and define the chain of custody for the transport and handling of microbial specimens, as well as proper documentation of patient data on specimen containers. SOP’s serve the following additional purposes: 1.) Improving the quality of laboratory services to patients and minimizing the consequences of poor performance. 2.) Instructions for consistent laboratory results. 3.) To minimize the implementation of ‘short cuts’ that might jeopardize performance standards. 4.)To provide written standardized techniques for the training of new laboratory personnel. 5.) To list appropriate reagents and equipment, and the standards by which they should be maintained. 6.) To promote safe laboratory practice. QUALITY CONTROL Quality control is a specific, internal means of control by which errors are accounted for after an initial phase of the production, or diagnostic process is complete. Ideally, when meaningful results have been achieved, quality control can be implemented to check for ‘mechanical’ process errors, and to ensure adherence to objective standards outlined in Quality Assurance procedures. QC is the ‘nuts-and-bolts’ testing of the material substance itself, the chemical verification that all reagents and testing modalities are functioning physically within defined parameters. QC ensures that the function of the laboratory proceeds in a means that will yield useful results and control for errors. QA is concerned with ensuring that these tests in fact occur, verifying their performance and documentation. Integral to the reporting of any data for a microbiology laboratory is the quality of the culture media used. Quality of media directly affects any inferences or observations extrapolated from the appearance and traits of microorganism colonies. Without the right chemical composition and condition, the behavior of growing colonies cannot be reliably predicted. Checking of various parameters of culture media such as growth supporting characteristics, physical traits, gel strength and the possibilities of contamination allow the necessary quality assessments. There are different systematic methods to verify these parameters. A meticulous performance of quality control of culture media assures the best chance of reasonable precision in reporting. Media quality directly depends upon the disposition of raw materials used therein. Even water itself must not be exempt from QC requirements; as it can often harbor interfering contaminant organisms. Chemical verification must also be conducted, to isolate and prevent factors that can interfere (or enhance) the growth of microorganisms. Water pH must be accounted for, as well as the presence of copper. Copper has been found to have antibiotic properties, inhibiting the growth of many bacteria. There should be a protocol to test for copper conductivity in pre-media water supplies for this reason. Conductivity should be limited to 15 µS (microsiemens) While the water should be acidic, it should not drop below 5.5 pH. (Bridson, 1998) Another potential for contamination is the Petri dish itself, and the quality by which it was produced. If Ethylene Oxide was used for sterilization it may interfere with microbial growth, amounts should be no greater than 1 µg/g. Gas Chromatograph methods are the preferred means to test for EtO. (Page, 1996) Autoclaving must be performed once the media has been formulated based upon the type of organisms to be screened for. The primary goal of which must be to create the combination of temperature and pressure necessary to kill bacterial endospores. (Fell et al. 2002) (Gould et al. 1967) The Clinical Laboratory Improvement Amendments (CLIA) regulations at 493.1256 and 493.1261 instruct laboratories to perform quality control on all testing systems and microbiology reagents. The subsequent results of the quality control analysis must meet both laboratory’s and manufacturer’s standards for acceptability. The laboratory must then document the resulting measurement, observation of quality control, or reaction. The quality control records should include lot numbers, date prepared or opened, and expiration dates. Under the guidelines of QA, mentioned above, laboratories must verify the purity and function of commercially-prepared reagents, identification systems, and chemical-embedded testing disks, (such as inducible resistance D-tests, and antibiotic-embedded disks for resistance testing.) and other systems for the identification and classification of positive or negative activity. Instrumentation and diagnostic tests that rely upon blood products or blood samples should also be subject to testing via Quality control. Other examples of specific products that must be screened for Quality Control are as follows: Bacitracin Catalase Cefinase Coagulase plasma Mycology germ tube tests (positive reactivity only) (Ortho-phenol beta-galactosidase) ONPG Optochin Oxidase Spot indole X and V factor (positive reactivity only) (Dwelle et al. 2009) Staining materials must also be checked for functionality on a regular basis. Fluorescent and immunohistochemical stains must be checked for positive and negative reactivity prior to every usage. Gram stain reagents must be checked each week of use, most other types of staining reagents must be checked for proper reactivity each day. (Dwelle et al. 2009) Reagents testing for Beta-lactamase activity (ability to cleave the Beta-lactamase ring) must be checked for positive and negative reactivity. In short, Quality control amounts to the physical testing of a product, and the reagents and equipment used to test the product, on a regular basis, to minimize the possibility of errors. Quality assurance does not perform physical tests, but is concerned with documentation that these tests have occurred. CONTINUOUS QUALITY IMPROVEMENT Continuous quality improvement, CQI is in essence, the fostering of an atmosphere in which workers and administrators strive constantly to improve quality standards. It builds upon traditional methods of Quality assurance to provide objective data that will lead to an improvement of processes. It is a management philosophy at odds with the old maxim of – “If it ain’t broke, don’t fix it.” The goal is to maintain high quality, but to contribute to an ongoing evaluation by which laboratory methods will consistently improve. QCI is a systematic approach, using proven methods to enhance overall quality of a service or laboratory endeavor towards the goal of higher-quality service. It relies on a corporate culture of proactive, continuous learning. CQI should be integrated into the core values and mission statement of the agency, laboratory, healthcare organization, etc.   It is aided by the active inclusive participation of staff at all levels throughout the improvement process. CQI is not a time limited project or initiative. It is the continuous process by which an organization executes decisions and evaluates its progress.  Creating a comprehensive CQI system requires significant time and effort. When the organization chooses to implement CQI, it is with the expectation that the process will go through several intermediate stages of evolution and development. Thus, the implementation of CQI requires sustained and commitment towards ongoing improvement by the institution’s leadership. Quality itself can be defined as meeting patient and customer expectations, and where possible – exceeding them. Serving patient and clinician needs is the definition of success in the microbial laboratory where mistakes do occur; we must be cognizant of the likelihood that fault lies not with personnel per se, but with the process. When honest technicians of professional conduct do not perform satisfactorily; that process itself must be examined for flaws or oversights. A process of small, incremental changes as needed creates an environment of continuous refinement in the ongoing pursuit of laboratory excellence. These improvements are most beneficial when integrated into the standard means for doing business. All laboratory personnel, including Health Care providers, must to learn how to improve the care and results that they give. Continuous quality improvement (CQI) is a theory and practice not limited only to the microbial laboratory, but used in a variety of disciplines to guide improvement. The question is how best to teach it, as a discipline on its own. It may be hypothesized that a systematic methodology to improve study habits and lifestyle would increase the awareness of learning professionals towards a familiarity with an improvement-oriented methodology. Some studies use the starting point that ‘quality is personal’, learning professionals should be tasked to work on personal change and improvement. The purpose was to learn methods and tools for improvement in their personal life and enable them to transfer and use this knowledge in their professional work. A study involving nursing students indicated that, for 75% of those surveyed, Continuous Quality Improvement yielded positive changes in both their professional work and personal lives. (Kyrkjebo et al. 2003) A commitment to QCI is more than just a platitude; studies indicate that where such policies exist, nosocomial infection rates have dropped significantly. Urinary tract infections and central venous catheter infections dropped significantly over a five-year study involving 1,764 patients in a hospital where a commitment to QCI was ongoing. (Misset, et al 2003) Results like these have prompted many hospitals to adopt a policy of continuous quality improvement as a means of injecting the scientific method into every aspect of institutional and laboratory management, no longer simply the province of formalized research studies. The benefits being improved patient care, and efficiency in basic operations. With this commitment, it is possible to create a statistical procedure for hypothesis evaluation to detect acute variations as they may pertain to nosocomial bacterial infections in hospitals or laboratories. Otherwise, an ongoing, systematic analysis of trends may not become a priority. Continuous Quality Improvement is a theory for change, and model for ongoing improvement – some models suggest a list of basic questions for administrators and professionals to use as they prepare themselves for the establishment of a comprehensive QCI policy: 1.) What are the goals of this institution? 2.) How will we know what changes equate to improvement? 3.) To what extent are changes possible that may result in improvement? (Langley et al. 1994) A study by Batalden and Stolz describes the types of knowledge that must be connected to achieve continuous improvement. The first may be described as Professional knowledge, which includes the functional details of technical disciplines such as chemistry, or microbiology. A second body of knowledge may be understood as Profound knowledge – which consists of four elements: 1.) Knowledge of the institution as a system of production 2.) Knowledge of deviations in personnel, products, and processes 3.) Knowledge of the psychologies involved with the work itself 4.) Knowledge of the psychologies of change 5.) Knowledge to link Theory with Action. (Langley et al, 1994) (Deming, 2000) Once this profound knowledge is linked with the professional knowledge of microbiology, and other disciplines, the time is ripe for action and change. (Deming, 2000) Instruction for quality improvement requires other educational opportunities not found in a classroom setting. The new QCI skillsets must eventually be utilized where needed, through practice in the workplace, or laboratory. Skills are best learned when they are integrated with practical disciplines, and a balance must be achieved between practical training and theoretical instructions. Donald Schon in a 1987 article outlines and approach that combines applied science with principles of coaching to achieve this link between theory and practice. Ultimately, in the microbial laboratory and other institutions, Quality Control is essential for the maintenance of the standards of production that allow professionals to stand by their results. But for QC to adequately function, it must have Quality assurance, as the impetus to ensure that the necessary physical tests and documentations are performed as required. But once these needs are satisfied, it is not yet time to rest on our laurels as professionals and cease development. For through an ongoing process of improvement, the quality, efficiency, and effectiveness of our labors can be continuously refined. References Arora, DR. (2004) Quality assurance in microbiology. Indian J Med Microbiol 2004;22:81-6 Basu S, Pal A, Desai PK. Quality control of culture media in a microbiology laboratory. Indian J Med Microbiol 2005;23:159-63 Bridson, E.Y. (1998) Culture Media In : The Oxoid Manual 8th edn. OXOID England: Limited Hampshire; 1998. p. 2-8 Deming W.E. (2000) The New Economics For Industry, Government, Education, 2nd edn. The MIT Press, Cambridge, MA. USA Dwelle, Terry M.D. Bartz, Darleen Ph.D. Pritschet, Bruce. Weidner, Bridget. Heilman, Shelly.Peterson, Rocksanne. (2009) Microbiology Quality Control. CLIA bits.Division of Health Facilities North Dakota Department of Health. Engbaek, K. Heuck, C. Piot, P. Rohner, P. World Health Organization. (2003) Basic Laboratory Procedures in Clinical Bacteriology,(2003) the Health Library for Disasters (HeLiD) Pan American Health Organization, Regional Office of the World Health Organization. Fell, Nicholas F.Pellegrino, Paul M.Gillespie, James B. (2002) HIGH SENSITIVITY DETECTION OF BACTERIAL ENDOSPORES VIA TB PHOTOLUMINESCENCE ENHANCEMENT U.S. Army Research Laboratory, Optics Branch 2800 Powder Mill Rd., Adelphi, MD 20783 Gould, G.W. Hurst, A. (1969) The Bacterial Spore (Academic Press, New York, 1969). Illinois Department of Public Health. Continuous Quality Improvement 101 http://www.luhs.org/depts/emsc/quality1.htm Accessed 5/26/2011. Last reviewed June 8, 2006. 1995-2005 Loyola University Health System. All rights reserved. Kyrkjebo, Jane Mikkelsen. MS RN. Hanestad, Berit Rokne PhD RN. (2003) Personal improvement project in nursing education: learning methods and tools for continuous quality improvement in nursing practice. 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(2000) Quality Assurance: Principles and Practice in the Microbiology Laboratory Public Health Laboratory Service, UK, 2000. ISBN 0-091144-452, ?25.00. Read More