Qa is associated with the three phases of quality assurance. Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process that produces patient results. This document details the writing, control, and distribution of microbiological test methods mtm for use in the gmp microbiology lab. Quality assurance qa is the total process whereby the quality of laboratory reports can be guaranteed. This manual has been designed to ensure quality assurance, including biosafety, in. Quality control of culture media in a microbiology. Quality assurance for microbiology in feed analysis laboratories. Part of quality control in microbiology is to keep the records of training to show that an analyst knew how to perform the task properly. Wed like to understand how you use our websites in order to improve them. Clinical microbiology laboratories may also use our protocol to validate culture media obtained from different suppliers.
Testing of media using standard protocol can save time and resources. Quality assurance is a planned system of control measures that enables management to ensure that the analytical data produced in the laboratory are valid. Pineapple research station k erala agricultural university, vazhakulam686 670, muvattupuzha. Bioburden contamination control is a critical aspect of pharmaceutical, medical device and personal. The result may be a patient result or it may be a quality control qc. Quality in the clinical microbiology laboratory clinical. Previous updates in this series presented information on the use of clinical microbiology tests and the role of the clinical microbiology laboratory for the diagnosis of infectious disease.
The term quality control covers that part of qa, which primarily concerns the control of errors in the performance of tests and verification of test results. Because the microorganisms used in this class are potentially harmful bl ii, no eating or drinking is allowed in the lab. Internal quality control internal quality control consists of all the procedures undertaken by a laboratory for the continuous evaluation of its work in order to ensure the consistency of results daytoday and their conformity with defined criteria. Home online lab manual quality control quality control methods including vitek qc, kirby bauer qc, etest qc, and serology qc. If using a kit, consult the manufacturers qc recommendations. Up to now, the focus has been on surveillance of laboratory procedures.
This chapter addresses the control of the analytical process in the laboratory, as distinct from meeting the typical analytical needs of a specific project. When a diagnostic test is performed in the medical laboratory, the outcome of the test is a result. Internal quality control is a set of procedures undertaken by the staff of a laboratory to ensure quality from the collection of specimens, the performance of the test as well as the analysis of results, with the procedure being planned, ordered and followed. A discussion of the centers for disease control and prevention standard precautions for avoiding transmission of bloodborne pathogens is included. Management and quality assurance in the microbiology laboratory lecturer. The importance of quality control in laboratory testing. Quality control of laboratory materials world health organization. This lab exposes students to various methods heat, uv radiation, antibiotics and chemicals used to kill bacteria and other microbes. Only media which provide an equal or better recovery capacity should be validated and introduced in the lab s routine. Internal lab qc reports from six microbiology units of a laboratory service showing differences in outcomes that indicate concern for quality control. Department of microbiology clinical laboratory manual. The term quality control covers that part of qa, which. Qc all new lots of identification cards once when received in the lab. Quality assurance in microbiology dr arora indian j med.
Quality assurance for microbiology in feed analysis. Cqi and pi seek to improve patient care by placing the emphasis s on not mistakes in the first place. Clean the lab table before and after lab with the 10% bleach solution provided. Quality control m ust be perf ormed according to man ufacturer instr uctions. Quality controls for microbiology lab equipment and lab. Quality of the specimen specify specimens rejection criteria eg. In the next decade, qa programs will broaden to include the entire process from a physicians test order to interpretation of laboratory results. Internal and external quality control in the medical microbiology laboratory article pdf available in african journal of clinical and experimental microbiology 194 august 2018 with 4,162 reads.
Microbiology quality control qc technician biotech careers. Each laboratory must have sops, sometimes referred to as the local laboratory bench manual. Cardinal health lab briefings is an educational webinar series that provides clinical insights, industry information, and hot topic updates across a variety of diagnostic related issues. Quality control refers to the process of detecting analytical errors within the lab to ensure both the reliability and accuracy of test results in order to provide the best possible patient care. Principles and practice in the microbiology laboratory there has been considerable revision, with the addition of several sections and many new contributors. If you are allergic to any antibiotics please inform the instructor immediately. Outline a qa program for the microbiology laboratory to include all phases of infectious disease diagnosis, and differentiate between external and inhouse qa audit programs. Or included in the bench manual for those who are new to the lab. The purpose of this update is to provide an overview of how clinical microbiology laboratories assure that the results of these tests are accurate, precise, and reproducible. Assuring the quality of clinical microbiology test results. The following procedure and protocol manuals are provided for our microbiology laboratory and are available as an educational reference for other laboratories. After the training the participants will be able to. Unreliable performance can result in misdiagnosis, delayed treatment and increased costs due to retesting etc.
The backbone of the book is a series of chapters addressing quality assurance issues in each area of the laboratory. To learn these, they can follow training procedures, which lay out in writing the best way to perform tasks. This handbook is intended to provide a comprehensive reference on laboratory quality management system for all stakeholders in health laboratory processes, from management, to administration, to benchwork laboratorians. Pdf internal and external quality control in the medical. Local and international approaches to obtaining safe food 3. February 15, 2002 vitek quality control follow schedule generated from lis for frequency of qc. To introduce quality assurance, all activities in the laboratory that affect the production of analytical data must be.
Bring efficiency through best practice to microbiology quality control testing safeguarding the purity and identity of quality control organisms through proper maintenance is critical to achieving accurate control results for culture media and reagents. Approach to quality management in microbiology laboratories. Quality control of culture media in a microbiology laboratory. Chapter 4 metrology covers precision and the related term accuracy purity assay.
Control products can be animal in origin, aqueous solutions or a commercially prepared organic matrix. Atcc reference strains are an essential component of quality control testing procedures and process validation, and serve as relevant tools in the research and development of new methods for testing food. These documents have been developed specifically for our institutions and may not be appropriate for implementation in other settings. Microbiology quality control technicians are responsible for assuring quality of the product through all daytoday operations. Cardinal health sponsors these webinars with support from leading industry experts and opinion leaders. Quality control qc the term qc covers that part of qa, which primarily concerns the control of errors in the performance of tests and verification of test results. To maintain internal links, we recommend the use of microsoft internet explorer. Microorganisms can be inhibited or killed by a variety of chemical agents and by chemical changes in their physical environment. Case 4 qc 22010 was a streptococcus pneumoniae isolate grown from the ear swab received from a 66yearold man.
Please examine the contents of table 1 before proceeding to the next section. Mandatory microbiological criteria which are written into law or government. Microbiology quality control thermo fisher scientific us. Quality control provides quantitative estimates of analysis and measurement controls that can be used to determine compliance with project objectives. Fda puts out a bam manual which has more depth and ther are several others worth looking into. They assist the biomanufacturing plant by evaluating raw materials, other supplies and the finished, packaged product. Ensure reproducible clinical test results and consistent microbiology testing for pharmaceuticals and food products with stringent quality control methods and quality control material that you can trust. Biochemistry and reproducibility interlaboratory variability. Microbiology module quality control in microbiology microbiology 148 notes tqm evolved as an activity to improve patient care by having the laboratory monitor its work to detect deficiency and subsequently correct them. The pertinent issues necessary for the establishment of quality assurance in the microbiology laboratory are discussed.
Since it was first published in 1991 under the title quality control. Quality control qc in diagnostic microbiology is a matter of effective, efficient, accurate. The validity of any microbialbased assay is dependent upon minimally passaged, fully characterized control organisms. A laboratory for the biological, microbiological, immunological, chemical. By using such tests, laboratories may improve their capacity to isolate fastidious microorganisms.
Microbiology quality control thermo fisher scientific ng. General microbiology laboratory wls labs, biol 3317 isbn. Qc must cover all aspects of every procedure within the department. Sop for entry and exit into quality control laboratory. Microbiology microbiology quality assurance programs are in a transition period. The quality management system in a microbiology laboratory. Microbial control laboratory exercise materials from the. In a recent qc compliance study in ontario, it was found that nccls qa recommendation was not followed at all. Gain efficiencies in qualitative quality control of clinical, food, and pharmaceutical products.
Quality in diagnostic microbiology semantic scholar. The quality control qc of media used in clinical microbiology laboratory remains critical for accurate and acceptable isolation of pathogens from infected patients. The lab manual includes a registration code to access mcgraw hill virtual labs extra credit in canvas. Compare the maintenance of reference quality control stocks in bacteriology, mycology, mycobacteriology, virology, and parasitology. These gmp training courses are tailored specifically to the needs of the microbiology and the quality contamination control functions for annual gmp training. Microbiological laboratory techniques target group. Quality issues are becoming increasingly important in diagnostic laboratories. It is essential that the quality of media be safeguarded to have a successful microbiology laboratory. Lab analysts need to know the right way to perform tasks. Laboratory quality assurance according to isoiec17025 clause 5.
Microbiological laboratory quality assurance apec fscf ptin. Biol 230 laboratory manual the grapes of staph table. They ensure compliance to common good manufacturing practices. Quality control quality control is a vital part of quality assurance all labs benefit from quality control in terms of confidence in and reproducibility of test results recording and monitoring test variables such as temperature, reagents, controls and equipment function allows one to look objectively and retrospectively at. Microbiology lab supplies microbiology quality control. Microbial control lab materials this is the main page for the microbial control laboratory topic of an 8week introductory college microbiology class.
All courses cover basic gmp with an emphasis on lab operations and contamination control and are tailored specifically to sterile or nonsterile needs. Quality control in microbiology linkedin slideshare. Apply to quality control supervisor, quality control manager, quality technician and more. Quality controls for microbiology thermo scientific quanticult plus pseudomonas aeruginosa atcc 9027 obtain fast and accurate identification of microbiological organisms with real biological organisms growing on fresh enriched microbiological culture media. Control of microbial growth by radiation and antibiotics. Quality control suggestions based on epa, standard methods, and iso 113 suggestions, microbiologics has developed a list of suggested strains for use in a water microbiology laboratory s quality control program. Principles and practice in the microbiology laboratory. Quality assurance in the microbiology laboratory springerlink. This handbook covers topics that are essential for quality management of a public health or clinical laboratory.
609 589 931 818 1293 126 78 163 1434 455 473 1502 584 1273 835 77 198 653 527 1091 146 1148 740 1005 605 1139 1164 153 492 1232 865 710