Click on the CAIVD to focus on our laboratory biosafety considerations
In addition to Laboratory Department of electrical equipment, a large number of highly toxic, flammable and explosive dangerous goods every day, accept all kinds of potentially infectious specimens may involve a, B, C, D, E hepatitis, AIDS, measles, rubella and epidemic encephalitis B, epidemic cerebrospinal meningitis, malaria, dysentery, syphilis, typhoid and paratyphoid fever, cholera and other infectious diseases, which requires the laboratory should put safety in the first place.
In order to ensure the safety, the design should be strictly in accordance with the relevant industry standards and laws and regulations to assemble the layout, especially the work flow, the distribution of the work area is reasonable will directly affect the safety of the laboratory. Safe passage, fire facilities, hydropower management and prevention of mouse anti mosquito, biological safety cabinet, vents, exhaust, drainage, automatic equipment, disinfection equipment layout should have a sense of control in detail, to ensure that qualified.
(1) the guiding principles for the occupational exposure protection of medical staff in the Ministry of Health (2004.6.1)
(2) the Ministry of construction, GB, the national standard for building technology standards for biosafety laboratories (2004.9.1) ()
(3) the State Administration of quality supervision, inspection and quarantine and the National Standardization Management Committee GB19489-2008 General requirements for laboratory biosafety (2008) mandatory national standards
(4) the State Council Decree No. 424 of pathogenic microbiology laboratory bio safety regulations (2004.11.12)
(5) the law on the prevention of infectious diseases in People’s Republic of China (Revised Edition) (2004.12.1)
The Ministry of Health (6) No. 45 human infected highly pathogenic bacteria (virus) or sample transport management regulations (2005.5.20)
(7) directory of pathogenic microorganisms for human infection (2006.1.10)
The Ministry of Health (8) No. 50 human infection of highly pathogenic microorganism lab and biosafety safety approval procedures
The Ministry of agriculture (9) No. 52 highly pathogenic animal pathogenic microorganisms laboratory bio safety management measures for the examination and approval of (2005.5.20)
(10)国家环境保护总局32号令《病原微生物实验室生物安全环境管理办法》（2006.5.1） (11) 常用化学危险品贮存通则（GB 15603-1995）(12)国务院445号令：《易制毒化学品管理条例》（2005.11.1）(13)中国合格评定国家认可委员会CNAS-RL05《生物安全认可准则》（2008.8.1）(14) 中华人民共和国卫生行业标准WS/T 249-2005《临床实验室废物处理原则》二医学实验室质量管理体系的合理建立
(10) the State Environmental Protection Administration Decree No. 32 microbiological laboratory bio safety environmental management measures (2006.5.1) (11) the use of chemical dangerous goods storage general (GB 15603-1995) (12) of the State Council Decree No. 445: precursor chemicals management regulations (2005.11.1) (13) China National Accreditation CNAS-RL05 biological safety accreditation standards (2008.8.1) (14) to establish a reasonable quality management system of People’s Republic of China health industry standard WS\/T 249-2005 clinical laboratory waste treatment of the principle of two medical laboratory
How to establish a set of scientific, standard, standardized quality management system, so that it can be normal operation and continuous improvement, is a very important and very confused question of each medical laboratory management workers.
Although there are many medical laboratories also set up their own quality management system, but is a mere formality, there are a lot of problems in the process such as: the laboratory management personnel or staff are not familiar with the standard documents and standard compilation does not match between the quality manual and process documents, risks in the process of formation file control, operation instruction is not refined or not according to the manufacturer’s requirements for the preparation, the risk is not timely corrective measures did not give continuous improvement. So, how do we avoid or eliminate these problems?
Most experts recommend using quality management method of PDCA cycle principle throughout the medical laboratory, to establish its system can be divided into four processes: P (LAN): planning and preparation of the quality management system; D (o): the preparation and operation of the quality management system documentation; C (Heck): Supervision and inspection the quality management system; A (ction): with the improvement of the quality management system.
Planning and preparation of quality management system
Quality management system planning and preparation is the key to the successful establishment of quality system, the main work includes:
1, all members of the medical laboratory to study the concept of quality management system, methods, objectives and related international standards, so that it can recognize the importance of the establishment of advanced quality management system.
2, clear medical laboratory management system quality policy and objectives. Medical laboratory should develop a quality policy that is in line with its own characteristics, determine the quality objectives around the quality policy, standardize the quality management, and standardize the quality activities.
3, to determine the organizational structure of medical laboratory. The organizational structure of the medical laboratory should be clear, affiliation with external and internal should be clear, the post responsibility, should be established, so that the Department staff can carry out their duties, mutual coordination and mutual supervision.
The operation of quality management system
The quality management system in the operation of the various activities may deviate, in order to ensure the effective operation of the quality management system, from the following points should be taken seriously:
1, document training. Need to develop a detailed training plan, and according to the training plan to complete the training content. Training should be carried out after the assessment, for the assessment of unqualified personnel need to re training and assessment, to meet the management requirements.
2, document management. Quality management system document management needs to develop a clear, documented procedures for the management of all quality management system documents and information control. Mainly include: document preparation, review, approval, the use of documents management; electronic document management.
3, process management. It is the difficulty of the quality management system of medical laboratory. Its contents include: pre inspection process, inspection process and inspection process. Before the inspection process is to determine the results of the test, true, accurate, the premise of its personnel involved in addition to the inspectors, but also including the medical staff and the patients themselves. The problem of any link can lead to the error of the test result. Selection, verification and validation to make inspection procedures for inspection in the course of establishing procedural documents in accordance with the Medical Laboratory of its own, formulate quality control rules effectively and accurately determine the authenticity of judgment or evaluation of the test results, and to take preventive measures did not reach such expected standards of the implementation of corrective measures in a timely manner. The quality control of the inspection process is the quality control measures which can provide the real, accurate and correct inspection report for the clinic in time after the completion of the sample detection. When the omission of this link, will make the process (process inspection and test management) come to naught.
Supervision and inspection of quality management system
In order to ensure the quality management system suitability, adequacy and effectiveness of patient care and support, improve and improve the shortage of quality management system in the construction of the medical laboratory should establish internal audit plan, inviting external agencies for review, regular management review. Internal audit or external agency review of the main audit system documents and accreditation standards, the effectiveness of the implementation of the system documents. Through the internal audit in system construction, operation process of nonconformity or potential nonconformity, and timely and effectively rectification, quality management system has been further improved to meet the development needs of the laboratory.
Quality management system documentation
Quality management system documentation is an important work of quality system. Quality management system documents can be divided into: quality manual, quality system procedures, work instructions (standard operating procedures), record form.
1, the quality manual is a programmatic document according to the actual conditions in the laboratory to write, is a core part of the quality management system documentation in the architecture, which mainly describe the quality management system, organizational structure, clear quality policy and quality objectives, roles and responsibilities of each position to determine the support program and the quality management system.
2, the quality system program is the elements of the quality manual deployment and specific expression, should have strong operability, the system file and a connecting role.
3, work instructions (standard operating procedures) is the quality system procedures supporting documents and refinement, medical laboratory technicians engaged in the work of specific inspection guidance.
4, record form is a record of the process state and process results, it is an important basis for quality management, information management is an important part of.
Improvement and improvement of quality management system
Through the supervision and inspection of the quality management system, the problems existing in the medical laboratory are found in time, which is the key point of the implementation of the next cycle of quality management system. To identify the cause of the nonconformity in the system, to assess the need for corrective actions, to take corrective actions and to record the results of corrective actions to prevent non conformance. For potential nonconformity in the system, determine the cause, evaluate the needs of preventive measures, take preventive measures, and record the results of preventive measures to prevent the occurrence of nonconformity. The laboratory shall continually improve the effectiveness of the quality management system through the implementation of management reviews. Only continuous improvement, to ensure that the laboratory quality management system is running well.
Therefore, if the reasonable of medical laboratory quality management system planning and design, in the operation of quality management system, to document the learning process management, control, supervision and inspection regularly, the risk of corrective and preventive. This will make the quality management system for a long time in a continuous improvement, continuous improvement of the state, greatly improving the quality and capacity of medical laboratories. 33 level general hospital accreditation and laboratory accreditation
Recently, many of the province’s top three hospitals will usher in a new round of three general hospital accreditation, according to the implementation of the general hospital accreditation standards for the implementation of the three, the third hospital laboratory will also be subject to review. On the other hand, more and more hospital laboratory in China application by the National Accreditation Committee (referred to as CNAS English) organization of the laboratory accreditation inspection department director, there may be some confusion, three grade comprehensive hospital accreditation and laboratory accreditation are the same, and the differences also reflected in what place.
A grade three general hospital accreditation issued by the Ministry of health in April 22, 2011 three level general hospital accreditation standards (2011 Edition) (Wei Yi tube 2011 No. 33), the evaluation standard policy basis for the September 1, 1994 promulgation of the medical institutions management regulations, the provisions of article forty-first national accreditation system medical institutions, experts from the review committee in accordance with the measures for evaluation of medical institutions and evaluation criteria, comprehensive evaluation of medical practice, the medical service quality. The evaluation methods and evaluation standards of medical institutions shall be formulated by the administrative department of public health under the state council.
In the evaluation standards, the United States JCI, Japan, Taiwan, Hongkong and other countries and regions of the hospital accreditation evaluation experience. In order to enhance the operability evaluation standards, strengthen the daily management and continuous quality improvement to guide the hospital, provide the basis for health administrative departments at all levels to strengthen the supervision and evaluation work, organization of the Ministry of health experts wrote the implementation of accreditation standards for grade three general hospital rules. Rules are set up in the 7 chapter of the 73 section of the 378 standards and monitoring indicators.
The implementation rules for the entire hospital review, covering the whole process of hospital comprehensive management and medical service, the fourth chapter improved medical quality safety management and continuous in section sixteenth clinical laboratory management and continuous improvement for the hospital review, this section includes 7 big 29 small clause clause.
From the evaluation criteria of Introduction to historical background can be seen, the review of grade three general hospital is dominated by the health administrative departments, comprehensive review and organize experts to review medical institutions, medical service ability, all three general hospitals must accept the assessment, inspection department as part of the hospital to accept the review.
Review of grade three comprehensive hospital is the national comprehensive deepening reform of the medical and health system, and actively and steadily push forward the reform of public hospitals, and gradually improve a measure evaluation evaluation system of our hospital, the purpose is to promote medical institutions to strengthen its construction and management, improve medical quality, ensure medical safety, improve medical services, to better fulfill their social responsibilities and duty, improve the medical service level and ability of whole industry.
Two, laboratory accreditation of laboratory accreditation? Accreditation is the process by which an organization gives formal recognition of the ability of an organization to perform a specific task. Authoritative institutions in China refers to the China National Accreditation Committee for conformity assessment, which is authorized by the China Accreditation Administration to carry out laboratory accreditation. Laboratory accreditation refers to authorized institutions in accordance with relevant international standards or national standards, the implementation of review of laboratory confirmed that meet the requirements of relevant standards, to further prove its related inspection activities engaged in technical and management ability, and issue a certificate of recognition.
According to the recognized standard for the international standard is drafted by international experts, and the strict procedures, technical requirements and advanced management concept, medical laboratory quality management system established in accordance with the guidelines of the requirements for medical laboratory technical review based on the international standard ISO15189 standard for medical laboratory quality and ability of the special the equivalent transformation of the national standard CNAS-CL02 medical laboratory quality and accreditation standards (ISO 15189, IDT) and in clinical chemistry, clinical hematology, clinical osology inspection, clinical immunology, clinical microbiology, qualitative test and molecular diagnostic laboratory information system 8 files.