The main problems of clinical testing and how to solve the proposal

The government requires medical institutions should be less investment to provide patients with the necessary medical services, the testing laboratory, is to minimize the cost of providing patients with timely, accurate and reliable test reports, but the actual situation is not so. At present, some hospitals only pay attention to the income and profitability of the laboratory, ignoring the necessity, rationality and reliability of the test, mainly in (1) in order to increase revenues for more laboratory tests or test items; (2) the use of inexpensive but high rebates or even reagents not approved by the state on the market; (3) do not pay attention to the establishment of a quality assurance system of testing, do not participate in the inter-room quality assessment program does not carry out indoor quality control; (4) the purchase of price more than the price of the test, but not the quality of the test, but the quality of the test. (4) the purchase of low-priced second-hand instruments of poor quality assurance. The existence of the above problems has led to the instability and unreliability of some test results, affecting the quality of care. The following is a brief report on the main problems within the Department of Laboratory Medicine, between laboratories in hospitals and independent laboratories for social services. First, the laboratory lags behind in internal management, quality control laxity In recent years, the hardware environment of the laboratory has improved greatly, the quality of the test personnel has also been improved, but the internal management of our department lags far behind the developed countries, the main reason for this is that some hospital directors simply see the laboratory as an auxiliary department and did not recognize the importance of the test medicine in modern medicine, do not pay attention to the test of the Construction, especially the construction of software. Laboratory director's excitement is also mainly in the laboratory hardware construction, ignoring the quality management, quality management of the laboratory is the core of quality control, quality control of science is very strong, there are procedural documents, operating manuals, quality control records, error registration and a lot of paperwork to be done, but the vast majority of laboratories are too troublesome and unwilling to do, and even some of the laboratory to control the accuracy and stability of the instrument and the control of quality control of standardized goods and goods Do not buy, fabricated quality control chart to deceive the hospital and testing center; some hospital leaders do not understand how the quality of testing should be managed, only purely economic benefits as a measure of the department's good or bad indicators, resulting in some of the Department of Laboratory only pay attention to the economic benefits and ignore the quality of the final loss is the country and the patient. Second, the test department set up confusion, the formation of adverse competition, affecting the quality of testing This type of problem is particularly prominent in large and medium-sized hospitals, according to the survey in Beijing, Shanghai, in addition to individual national hospitals in addition to the Department of Laboratory Sciences has no fewer than 30 clinical laboratories to the patient to issue a report, and even a hospital with the same laboratory project there are a few laboratories competing for the patient's situation, so that patients are at a loss, and individual departments and even to give the doctor a referral fee to attract patients. Individual departments even give doctors referral fees to attract patients. With the development of laboratory medicine science, by the Department of Laboratory Medicine to cover all the hospital testing program is not possible, in order to save medical resources, some special projects in the clinical laboratory both to do scientific research and carry out clinical testing of this is not wrong, but due to the clinical laboratory business is not under the leadership of the Department of Laboratory Medicine, its quality control and quality assurance can only be self-restraint and no external supervision. Such as drug concentration test most of the hospital pharmacy to carry out, it is understood that the national drug concentration test laboratory in more than 500, the Ministry of Health Clinical Laboratory Center (Clinical Laboratory Center) from 1992 to carry out the quality control and evaluation of the test to date, there are only less than 50 laboratories to participate in this activity, less than 1/10 of the total number of similar cases there are many more, due to the lack of clear documentation to carry out clinical testing of the laboratory should not be used for research and clinical testing. Documentation to carry out clinical testing laboratories should be how to manage the scope and strength of the test center to monitor the constraints, can not give full play to its role. Third, the development of independent laboratories to carry out socialized services lack of standardization, guiding documents Whether in developed or developing countries, independent laboratories have existed for many years, and a set of sound supervision and management measures, it has been proved that the provision of independent laboratories to provide socialized services to save health resources, to supplement the hospital's experimental projects, to carry out high-tech and provide fast service, and so on, has played a positive role. By the state, hospitals and patients *** with the recognition of China's health administration has been encouraging and advocating the development of socialized clinical testing services over the years, but due to the policy and the hospital fee system, so that the development of the work has been greatly constrained. With the gradual deepening of the reform of the national health care system, the socialization of clinical testing services is also a major trend, Yangzhou City Clinical Laboratory Center from the mid-80s to carry out social services, and has achieved good results. However, it should be noted that some businesses are also optimistic about this market, investment and equipment and hospital cooperation, the establishment of cooperative laboratories in hospitals to open up to the community, such as a company in the country to establish a network of radioimmunization centers, some companies have established a polymerase chain reaction laboratory network, each network has hundreds of hospitals involved, such laboratories mainly have the following characteristics: (1) the establishment of laboratories in the hospitals (1) the establishment of laboratories in hospitals can avoid the approval and supervision and management of health administrative departments and environmental protection departments; (2) for profit-making purposes, the use of their own production of unregistered instruments and reagents, to avoid the audit and approval of the State Drug Administration; (3) the laboratory set up non-standardized, low-quality personnel, can be made to make up; (4) no quality control measures, do not participate in the inter-laboratory quality assessment and do not carry out indoor quality control. This type of laboratory is actually in a management vacuum, recently found in Beijing, a company invested in the radioimmunity room individual test personnel do not do the laboratory fabricated reports, false, fraudulent, cheating hospitals and patients. There is also a class of laboratories open to the community, is mainly engaged in scientific research within the hospital laboratories, such laboratories open to the public is no cause for criticism, but individual laboratories to exploit the loopholes in the management of hospitals, in the name of scientific research to apply for instruments and reagents, and then used for commercial testing services, the charges can be reduced to half of the charges set by the Beijing Municipality, the reason is that the reagents and instruments are cost-neutral, so that state-owned assets in disguise, the state-owned assets of the hospitals, the hospitals, the hospitals, the hospitals and the patients. This is a disguised state-owned assets into their own pockets, the vast majority of such laboratories do not have strict quality control measures. Although there are not many independent laboratories open to the public, they are developing rapidly and many problems have emerged. Fourth, the solution to how to solve these problems, we believe that the best and most effective solution is to establish and improve the relevant laws, regulations and departmental rules, the implementation of clinical laboratory accreditation of medical institutions, laboratory accreditation system can be the U.S. CLIA88 (U.S. Laboratory Management Legal Document) as a reference or to the International Organization for Standardization (ISO) Guideline 25 for accreditation basis, Guideline 25 from the organization and Guideline 25 evaluates and accredits laboratories in 11 aspects: organization and management, quality system audit and review, personnel, facilities and environment, equipment and standard substances, measurement traceability and calibration, calibration and testing methods, sample handling, records, certificates and reports, subcontracting, external support services and supplies, and complaints, etc. The Chinese government has already adopted this standard and established the "National Laboratory Accreditation Committee" (NLAC) under the State Bureau of Technical Supervision (SBTS). "The National Laboratory Accreditation Committee has been established under the State Bureau of Technical Supervision (SBTS) and has been accrediting laboratories in various industries in China, and it is said that they are currently considering accreditation of hospital laboratories. The Beijing Municipal Bureau of Technical Supervision is already preparing to accredit the laboratories of medical institutions in Beijing in May this year, and the Shanghai Municipal Bureau of Technical Supervision is also considering the matter. The Center believes that hospital laboratories serve a special population, different from the average consumer, secondly, hospital laboratories and other laboratories in the traceability of quantitative values are very different, and thirdly, the Ministry of Health on the hospital laboratory in the inter-room quality assessment and indoor quality control of many years of experience and practice, has its own particularities. ProCTC suggests that the Department of Health should start early on the management and supervision of this work, accreditation can take the following principles. 1 Laboratory accreditation standards can be developed on the basis of ISO Guideline 25, taking into account the characteristics of clinical testing laboratories. 2 for medical institutions and blood collection agencies within the laboratory accreditation can be taken on a voluntary basis, the maturity of an accredited one, do not go in a flurry. 3 The principle of mandatory accreditation of clinical laboratories to carry out socialized services. 4 The establishment of the accreditation system for assessors, all reviewers are required to go through off-the-job training and pass a special exam, the exam passers into the assessor expert database, each review from the expert database then extracted assessors.