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1、述评 Our experience and commentaries on improving clinical laboratory services in China Li-ming BAO1， 2 （1. Sino-US Joint Clinical and Molecular Laboratory， Fudan University，Shanghai 200032， China； 2. Division of Human Genetics， Cin- cinnati Children s Hospital Medical Center and University of Cincinn
2、ati College of Medicine， Ohio 45229， USA） KEY WORDS Genetic testing；Laboratories，hospital；Quality control；Total quality management；China The Sino-US Joint Clinical and Molecular Laboratory（JCML）is a comprehensive clinical research laboratory with main focus on study of hematopoetic diseases includin
3、g myelodysplastic syndrome，leukemias and lymphomas. The JCML is located in the Shanghai Medical College of Fudan University（formerly Shanghai Medical University） in Shanghai，China and was established as part of a large multi-center，international study of benzene health effect in China that is sponso
4、red by the international consortium on benzene health effect. The JCML conducts the studies in the areas of histopathology，hematology，flow cytometry，clinical cytogenet- ics， fluorescence in situ hybridization（FISH） ， clinical molecular pathology， cell culture， and tissue preservations. The JCML is e
5、quipped with state-of-art laboratory testing instruments and supplied with high quality reagents. Some of the major instruments include the first in the nation five-laser flow cytometry for immunophenotyping analysis， digital imaging systems for chromosome and FISH analysis，the Discovery s system fo
6、r automatic FISH sample preparations，automatic blood analyzer，large cell culture and tissue preservations facility. Since its inception in 2003，the JCML has established working relationship with 28 major hospitals in Shanghai to conduct the world largest study of hematopoietic diseases including mye
7、lodysplasia，leukemias and lymphomas according to the World Health Organization（WHO）classification. By combining morphology，immunphenotyping and genetics analyses，the JCML offers world-class quality of laboratory testing that were rarely available in China. The JCML has become the center for clinical
8、 molecular study of hematological diseases in China and the world. During the past 2 years，the JCML served over 1 500 patients suspected of having hematological disorders and gath- ered a large amount of valuable clinical data. The study has already resulted in several publications in international
9、journals. Here，we would like to share some of our experiences in practicing laboratory testing in China according to international standards. At the very beginning of the laboratory-building process，we fully realized that even the 2-million-US-dollar a- vailable for us at that time for setting up la
10、boratory infrastructure would not guarantee a first-class laboratory. The key would be dedicated and competent staff and effective operational management. Therefore，staff training and continuing improvement have always been top priority in the JCML. Most of our laboratory staff had no prior experi-
11、ence in clinical laboratory when they joined the JCML. The key laboratory staff members received extensive training in clinical laboratory testing in clinical laboratories in the United States. They not only learned the techniques and methodologies related to the clinical tests，but more importantly
12、practice those in the context of high standard quali- ty control and quality assurance. All the laboratory directors have had oversea experience and one of them is also currently directing a clinical laboratory in the United States. We spent over one and an half years on staff training， developing a
13、nd validating testing procedures，and setting up QC/ QA programs prior to accepting patient samples. In JCML，we adopted many guidelines set by the US College of American Pathologists（CAP）and American College of Medical Genetics（ACMG） . For instance，we follow the ACMG guidelines for clinical genetics
14、laborato- ries for our genetic analysis. In many occasions，these mean extra works such as setting up more cell cultures，ana- lyzing more cells and having more controls that may otherwise not needed according to local practice. The JCML has detailed written procedures for all the tests it performs an
15、d most of the tests are analyzed by at least two laboratory technologists. Each step of analysis is detail recorded. The testing results are reviewed by both Chinese and US ex- perts. The laboratory tracks major testing technical parameters such as monthly abnormal rates and culture failure rates. A
16、ll of these require either additional resources or additional training on laboratory staff. But the benefits are evident，problems are often identified at early stage and resolved before they become significant issues. Most impor- tantly，the patients receive high quality reliable testing results. For
17、 example，our leukemia bone marrow cytogenet- ics analysis success rate is over 95% and AML chromosomal abnormality rate is over 64%. These numbers along with many others are better even compared to most of the laboratories in the United States. The JCML is very much involved in the sample collection
18、 process. We know that this is critical for having good testing results. The laboratory provides hospitals with sampling collection kits and other necessary supplies and rea- gents. The JCML has a team of three designated members who go to hospitals to work with physicians on sample collection and t
19、o perform initial sample process before being transported to the laboratory. The goal at JCML is to do as thorough analysis on each sample as possible. For instance，the JCML does FISH screening analysis on all patients suspected of having myeloid disorders using a panel of probes. In many cases， add
20、itional FISH probes may be added to characterize chromosomal abnormalities suggested by either conventional Corresponding author s e-mail， liming. bao cchmc. org 52 北京大学学报 （医学版） JOURNAL OF PEKING UNIVERSITY （HEALTH SCIENCES） Vol.38 No. 1 Feb. 2006 cytogenetics analysis，pathology or immunophenotyping
21、 analysis. PCR-based molecular analysis may also be added to further define genetic aberrations. Just FISH testing alone，the JCML performs about 300 -400 FISH tests each month for hematological diseases. The JCML has become one of the largest FISH laboratories in China in study of hematological dise
22、ases. We realize the importance of timely reporting on testing results in practice of evidence-based medicine. All the efforts are made at the JCML to reduce the test reporting time or turn-around-time（TAT） . TAT is the interval be- tween the time the sample is received at the laboratory and the tim
23、e the test result is reported. The JCML has a tri- age system to prioritize testing based on patient s clinical conditions and testing results. In JCML，most tests are completed within 7 days. Even for time-consuming and technical challenging studies such as bone marrow and lymph node cytogenetic ana
24、lysis，results are usually available within 7 days. The average of 7-day TAT for cancer cytogenetics analysis places the JCML at the top tiers among the peers in the world. With the advantages of all tests performed in a centralized location at the JCML，we are able to collaborate morphology，immunophe
25、notyping and genetics studies when comes to final diagnosis. Laboratory reports include a summary of all the testing results along with individual test reports with detailed information for each analysis. The reports outline the clinical significance of the laboratory findings and in some cases，reco
26、mmendations and sugges- tions for future studies are also included. The JCML has an Oracle-based，fire-wall protected database that plays important roles in data process and la- boratory operations. From the time the sample is log-in at the laboratory to the time the results are reported，the sample p
27、rocesses and status of the tests are managed through the database. The database which is accessible through the Internet makes it possible for directors to review testing results remotely if needed. This allows the tes- ting results being reviewed promptly. Finally， this bilingual database is also e
28、ssential for conducting a large interna- tional collaborative study that is often involved investigators from different countries. All patient-related materials and clinical information including cell pellets，slides，DNA and RNA samples， paperwork and electronic information etc are permanently stored
29、 in secured locations in the laboratory. During past few years，we were fortunate to be able to make some positive contributions to improve clinical la- boratory testing in China. We witnessed great strides made in the field of clinical laboratory testing in China. Pa- tients and physicians have been
30、 embracing high quality clinical laboratory testing and are demanding better. But at the time，we also met many challenges and just like many other laboratories in China do. The followings are some thoughts on what may need to be addressed to improve clinical laboratory services in our nation. First，
31、we feel that better nationwide guidelines for clinical laboratories would be helpful. Such guidelines may list detailed standards for personnel qualification，quality assurance and quality control programs，proficiency pro- grams，manual and procedures，personnel safety etc. Such guidelines should lay b
32、etter groundwork for setting up guidelines for special clinical testing. With a rapid growth of clinical laboratory testing services both in state-run hospitals and medical centers and privative commercial settings，it becomes more and more urgent to have such standards to control quality and to prom
33、ote healthy growth of the field across the nation. The news from the recent International Symposium on Genomic Medicine in Shanghai that the Chinese National Center for Clinical Laborato- ries was in the process in drafting a blueprint of national guidelines for clinical laboratories similar to the
34、US NCCLS is very promising. Along the same line are nationwide guidelines for clinical genetics laboratories. Although the American College of Medical GeneticsStandards and Guidelines for Clinical Genetics would serve as a good reference，thoughtful discussions and thinking processes will have to tak
35、e place order to have guidelines and standards that reflect Chi- nese practices and values. Other important issues such as safe-guide for patient genetics information and measures against genetics discrimination should also be important parts of the guidelines. The guidelines should be estab- lished
36、 in accordance with common international clinical laboratory/ testing practices. By doing so，our clinical tes- ting results and clinical studies will not only meet higher standards but also make it easier to communicate with the rest of the world s medical genetics community. Furthermore，the guideli
37、nes should also promote international col- laborations on medical genetics research. All the proposed guidelines and standards can not be fully implemented in laboratory practices if they are not parts of requirements for clinical laboratory accreditations and certifications. Therefore，these guideli
38、nes should be developed in collaborative fashion with consensus between professional organizations and government regulatory a- gencies. The checklists for inspections and certifications of clinical laboratories should be consistent with the pro- posed national guidelines and standards. Nationwide p
39、roficiency testing programs for genetic testing would be helpful to standardize genetic testing prac- tices in China. Currently，some laboratories participate in oversea programs such as CAP in the United States and United Kingdom National External Quality Assessment Scheme in Clinical Cytogenetics i
40、n Great Britain. China s own nationwide inter-laboratory proficiency testing programs for genetics testing should include a list of the tests for the diseases commonly tested in China and be consistent with the Chinese clinical laboratory standards. Such pro- grams should be affordable and serve as
41、important tools for quality control and improvement. Although the concept of evidence-based molecular medicine is being more and more accepted，there are still many doctors and healthcare administrators who have not fully appreciated roles of molecular testing in modern med- 62 北京大学学报 （医学版） JOURNAL O
42、F PEKING UNIVERSITY （HEALTH SCIENCES） Vol. 38 No. 1 Feb. 2006 ical practices. Efforts could be made in several fronts. First is to update medical school curriculums with current knowledge on medical genetics and molecular medicine. Molecular pathology should be important training compo- nent for pat
43、hologists and graduate students. Second，molecular medicine should be incorporated into continuing ed- ucation materials for physicians. It is equally important to increased awareness of general public on the roles of medical genetics and molecular medicine in patient care. Nationwide standardized tr
44、aining and/ or residency programs on medical genetics and interdisciplinary special- ties such as molecular pathology should be important part of the efforts to train next generation of medical geneticists and other molecular medicine practitioners. The programs which may be first established at sel
45、ected major medical centers in the nation should offer related courses and prepare trainees with adequate clinical and laboratory experi- ences in respective specialties. The trainees are expected to pass standardized certification examinations after com- pletion of the training. One of the keys to
46、accomplish these goals is to recognize medical genetics as an independent clinical specialty. Such recognition will attract and retain the best and the brightest into this promising field. There were several significant developments along that direction. Professor ZHANG Si-zhong and the Chinese Soci
47、ety of Medical Genetics made a proposal to recognize medical genetics as a clinical specialty. Peking University estab- lished a new Peking University Center of Medical Genetics（PUCMG）directed by Professor Nanbert ZHONG and its plans to launch China s first medical genetics and genetic counseling pr
48、ograms for their medical students. Finally， medical communities and pharmaceutical companies should work more closely with government regula- tory agencies to facilitate the processes of introducing latest medical technologies and testing reagents to our patient care. We believe that this should be
49、done in the ways that patient safety would not be comprised. Although there are many challenges ahead，we are confident that in the era of evidence-based medicine and genomic medicine，clinical laboratory testing and genetic testing are going to continue to strive. As the results，we will be able to provide even better laboratory testing services to our patients and to continue to make significant con- tributions to the world medical community. We are living very exciting period in the history of medicine. （Acknowledgement： The author would like to express gratituele to Professo