Clinical microbiology laboratory quality management and standard operation procedure

Date of publication:2010-1   Press: People's military medical   Author:Zhang Xiuming Lan Haili Lu Lanfen   Pages´╝Ü526  

Quality is the eternal theme of. Clinical examination quality is directly related to the diagnosis and treatment of the patient, how to improve the medical laboratory quality management and detection technology capabilities to ensure inspection quality, has become the core issue of discipline construction of medical laboratory. "Special requirement of medical laboratory quality and ability --" (ISO15189) international standards, providing a scientific method for quality management in medical laboratory, laboratory accreditation system for medical laboratory provides an effective way to social proof of its detection technology. Many laboratories have to obtain the laboratory accreditation as a quality and technical management objectives. Guangdong Province Zhongshan People's Hospital (Zhongshan Hospital Affiliated to Zhongshan University Medical Center) began preparations for medical laboratory accreditation in 2004 2007, won the August China National Accreditation (CNAS) issued by: ISO15189:2003 accreditation certificate, become the standard accreditation of medical laboratories by the national ninth. In 2008, according to the "medical laboratory quality and accreditation standards" (CNASCLO2:2008) the improvement of the quality management system, and in 2008 November passed the supervisory review and expansion of the assessment, in 2009 April won the CNAS issued by ISO15189.2 007 certificate of accreditation, accreditation through the project 273, professional fields covering clinical blood and body fluids, clinical examination biochemical, clinical immunology test and clinical microbiology testing 4 professional, is by far the country through the recognition of most medical laboratory. Clinical microbiology laboratory is an important branch of laboratory medicine. The microbial test itself has certain subjectivity, experience, influence factors of test results, the clinical microbiology laboratory to standardization, standardization. Therefore, the clinical microbiology laboratory in accordance with the ISO15189 quality management system and through the laboratory accreditation is even more necessary. "Clinical microbiological quality management standard and inspection procedures" in accordance with the ISO15189 quality system standard to establish and guide books on job requirements to compile. The book according to microbiology laboratory work flow, followed by the introduction of the Medical Laboratory of clinical microbiology laboratory quality management documents, preparation of reagents and culture media, the operation and maintenance of equipment, collection, approval and inoculation treatment program, all samples, the microbial identification procedures, all kinds of testing, testing related antigen antibody, antimicrobial susceptibility test procedure, the sample processing report and inspection, quality assurance and so. The book includes 114 standard operating procedures (SOP) and 61 quality and technical records, is we are in preparation for laboratory accreditation process in the crystallization of collective wisdom and experience. In view of the domestic clinical microbiological examination of standard operating procedures, less to collect books, the book presents to the readers, and we write "medical laboratory quality management and accreditation practice", "clinical test method evaluation", "the specimen collection", "Handbook of clinical biochemistry laboratory quality management and standard operation procedure" together formed a series of monographs, aiming for is planning or preparation for laboratory accreditation of medical laboratories to establish a quality management system and provide reference to write standard operating procedures. The editor of standard understanding ability is limited, can hardly be avoided shortcomings and mistakes in the book, please readers and expert criticism, and made valuable suggestions to make up for deficiencies. The laboratory has been a testing laboratory of Peking Union Medical College Hospital, Wuhan Tongji Hospital and guidance and help in preparation for laboratory accreditation, has been the strong support of Zhongshan People's Hospital, functional departments at all levels of leadership, clinical and laboratory medicine center of all my colleagues, thanks.

The book is divided into 11 chapters, discusses the management system documents, preparation of reagents and culture media, the operation and maintenance of equipment, collection, approval and inoculation, processing of various specimens, identification procedures of various microorganisms, various identification test, associated antigen antibody test, antimicrobial susceptibility test results, sample processing report and inspection, quality assurance and so. The book with the related international and national standards of medical laboratory. The book is comprehensive, the format specification, the language easy to understand, easy to understand, strong operability. Book with a lot of chart, which can be directly used for the clinical microbiology laboratory personnel reference. The book is the laboratory quality management system establishment and application for laboratory accreditation an important reference book.
Catalogue of books

Evaluation of training and assessment of sixth section staff capacity first chapter management file section structure of second section management system of third section of various personnel duty fourth day post responsibility system in section fifth and section seventh of employees authorized and clinical communication program eighth service commitment ninth day work flow chart tenth environmental monitoring management program section eleventh species management program: the twelfth section report of infectious pathogens, storage and transportation of medical waste disposal program thirteenth program fourth bio safety management in Cheng Xudi chapter two reagent and medium preparation section of commonly used medium preparation procedure section second commonly used reagent preparation procedure chapter third equipment operation, maintenance section MicroScan microbial identification and drug sensitivity analyzer operation program second MicroScan microbial identification and drug sensitivity analyzer maintenance procedure third BacT / Alert120 automated microbial culture system operation procedure fourth BacT / Alert120 automatic microbial culture instrument maintenance procedure section fifth biological safety cabinets use and maintenance procedures sixth day high Pressure sterilizer usage and maintenance procedure section seventh photoelectric nephelometer using and maintenance procedure section eighth electric thermostatic water bath box use and maintenance procedure section ninth microscope using and maintenance procedure section tenth electronic balance the use and maintenance of program eleventh high-speed centrifuge use and maintenance program section twelfth UV the lamp use and maintenance program section thirteenth electrothermal high-temperature inoculation sterilizer usage and maintenance procedure section fourth drug pipettes use and maintenance procedure section fifth constant temperature incubator use and maintenance procedure sixteenth ordinary refrigerator and freezer using and maintenance procedure chapter fourth specimen collection, approval and with the first day of specimen collection, transportation and preservation program section second specimens of nuclear and vaccination program section third emergency sample processing procedure chapter fifth various specimen processing procedure section 1 blood and bone marrow specimens handling procedures second CSF specimens handling procedures third urine specimens handling procedures fourth phlegm and lower respiratory tract specimens The processing program of section fifth stool specimens of sixth section handler pus and wound specimens handling procedures seventh puncture fluid specimen processing program eighth catheter specimen processing section ninth genital specimens process section tenth eye, ear, nose, throat specimen processing program eleventh nails, dander, hair samples the processing program of section twelfth specimens from thirteenth day process various specimens smear test procedure in section fourth nosocomial infection surveillance specimen processing program sixth chapter various microbial identification procedure section 1 of Enterobacteriaceae identification procedure section second non fermenting bacteria identification procedure section third Vibrionaceae bacteria identification procedure section fourth gram positive cocci identification procedure section fifth Neisseria and Branhamella identification procedure section sixth gram positive aerobic and facultative anaerobic bacteria identification procedure section seventh rare gram negative small bacilli identification procedure section eighth anaerobic bacteria identification procedure ninth L bacterial identification procedure section tenth Mycobacterium and Nocardia identification procedure section eleventh fungi The identification procedure section twelfth mycoplasma culture and drug sensitivity tests of seventh kinds of identification test procedure chapter first section MicroScanNC31, NUC33 test procedure second MicroScanPC20 test procedure third API20E test procedure fourth API20NE test procedure fifth API20Strep test procedure sixth APINH test procedure seventh APICoryne test procedure eighth API20A test procedure ninth API20CAux test procedure tenth APIStaph test procedure in section eleventh Gram staining procedure section twelfth ink staining procedure section thirteenth acid fast staining procedure section fourth oxidase test procedures in section fifth, catalase test procedure in section sixteenth rapid latex agglutination test for detection of Staphylococcus aureus test procedure seventeenth CAMP the test procedure in section eighteenth Aupu Tuoxin test procedure in section nineteenth bacitracin sensitivity test procedure in section twentieth Haemophilus factor test procedures eighth chapter related antigen antibody detection of Chlamydia trachomatis antigen detection section Procedure second Salmonella diagnostic serology test procedure in section third Shigella diagnostic serology test procedure fourth 0157:H7 Escherichia coli diagnosis serological test procedure in section fifth, Ot group Vibrio cholerae 0139 diagnostic serologic test procedure chapter ninth antibiotics susceptibility test section of MicroScan microbial identification and drug susceptibility analysis of drug sensitivity test procedure second disk diffusion susceptibility test procedure third E-test susceptibility test procedure in section fourth of yeast like fungi ROSCO drug sensitive test procedure in section fifth of Staphylococcus to oxacillin, vancomycin resistant and inducible clindamycin resistance test procedure in section sixth of vancomycin and high level aminoglycoside resistance in Enterococcus the detection procedure section seventh of Enterobacteriaceae producing extended spectrum beta lactamases screening and confirmatory test procedure in section eighth penicillin resistant Streptococcus pneumoniae detection procedure section ninth penicillin sensitive staphylococci detection procedure section tenth beta lactamaseThe detection procedure section eleventh carbapenemase producing Enterobacteriaceae bacteria screening and confirmatory test procedures tenth chapter report and test specimen processing section of microbiological test report program section second microbial test critical value reporting procedures in third day test specimen storage and handling procedures fourth bacterial drug resistance monitoring procedures chapter eleventh quality assurance section MicroScan microbial identification and drug sensitivity analyzer quality control section second microbial culture system to monitor the quality of the program in section third of the autoclave quality monitoring program section fourth diagnostic reagent quality control section fifth medium quality control procedure sixth API reagent quality control section seventh disk diffusion susceptibility test quality control program eighth E-test susceptibility test quality control section ninth yeast like fungi ROSCO drug sensitive test quality control section tenth indoor quality control procedure eleventh day room quality assessment program section twelfth quality assurance procedures section thirteenth quality improvement procedures in Appendix A of medical laboratory quality and accreditation criteria appendix B medical laboratory quality and ability of clinical microbiology laboratory accreditation criteria in the field of appendix C of pathogenic microorganism laboratory bio safety management regulations
Chapter excerpt

Illustration: 4.1.4 on the received samples and sterile, reagent, respectively, according to the specified location, there are obvious separation. The used tube, plate, culture etc. all high-risk waste should be timely sterilization before leaving the laboratory. 4.2 facilities of the management of 4.2.1 laboratory facilities shall meet the "bio safety lab.Construction technical specification "(GB50346-2004) requirements and after acceptance, bio safety, dust, noise, vibration, electromagnetic shielding, radiation protection, grounding resistance are in line with the equipment and the requirements of test standard. 4.2.2 precision testing equipment according to the requirements placed on solid ground or experimental platform, adjacent to a large instrument do not have vibration source, heat, radiation, harmful dust and gas, the equipment has three levels of maintenance system according to the instructions provided, and implementation and the corresponding record. 4.2 specimens of -3 storage and cold storage, preservation reagent large water bath box, incubator, low temperature refrigerator, temperature control equipment to provide the use and maintenance of the system, monitor the temperature of the thermometer should be point to point calibration, when the temperature is out of control due to emergency treatment measures. Air conditioning system 4.2.4 microbial were independent, the establishment of 3 negative pressure chamber and a 2 pressure chamber, need to adjust the temperature and humidity and non circulating clean air in the chamber, inlet filtration system by hospital air conditioning class each week for cleaning and maintenance. 4.2.5 biological safety cabinet shall be placed with the correct use and maintenance, regular monitoring of performance to ensure security purposes. 4.2.6 for the autoclave sterilization should be required to place a dirt, use, maintenance, the correct exercise regular quality monitoring. 4.3 environmental management requirements of 4.3.1 according to the laboratory test items or equipment requirements, establish the laboratory environment control conditions, staff every day to monitor the environmental temperature and humidity and record. The storage of food and eating not within 4.3.2 laboratories, any operation can not wear and remove contact lenses is not conducive to their own biological safety protection. 4.3.3 after the end of the work to deal with related work table, regional, samples, reagents, finishing, to ensure that the environmental conditions of the neat and orderly. 4.3.4 shall be equipped with corresponding memory space, in order to ensure complete preservation of documents, books, records and test results. 4.3.5 has a separate hand washing pool, a skin disinfectant and chlorine containing disinfectant, for there are disinfected biological pollution. 4.3.6 laboratory with eye wash, to face, eyes, nose and other pollution timely treatment purposes, but should be checked regularly, ensure its effective use. 4.3.7 indoor air daily ultraviolet light disinfection, to the regular monitoring of the disinfection effect, and recorded in the "Laboratory of Zhongshan People's Hospital medical center of UV disinfection records".
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"Clinical microbiological quality management standard and inspection procedures": Medical Laboratory Accreditation of reference books
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User reviews
  •   Write very detailed, laboratory certification preparation work
  •   The book wrapped in plastic, very new, very good quality!
  •   Very useful, quality is also very good.
  •   It is helpful to improve the inspection technology.
  •   A useful book, if there is a word version, direct gear down with good
  •   Something good, the price is not expensive, of course, help units to buy, ha ha
  •   More practical, can be used to improve entry.
  •   For SOP, has a certain reference significance for the book.
  •   Mainly they unit certification work SOP summary, can refer to, but is not practical.

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