Quality assurance of computerized system for GLP laboratory / 药物评价研究

In view of the characteristics of the computerized system,the key points in the quality assurance (QA) of the computerized system was discussed and summarized combined with the requirements of the GLP laboratory in Europe and America.The validation of computerized system,the control during the use of computerized system,period maintenance and safety protection of computerized system,archives of electronic data was discussed,expecting to provide reference for the management of computerized system in Chinese GLP laboratory which is generally not high currently.The experiences were obtained as follow:Through repeated inspection and review,the problem was found and set as the risk point;a targeted QA inspection plan was made focusing on the risk-based inspection and the QA inspection plan was timely adjusted according to the problems,which ensures the pertinence and validity of the QA inspection.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2008) / 임상검사와정도관리

Two trials of external quality assessment were performed in 2008. The first and the second trials assessed by three test categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items using immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 437 institutions in the first trial survey and 476 institutions in the second survey.Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 437 and 476 laboratories and the response rate were 94.6% and 98.7% in 2008. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Some analyzers of a few test items showed variations of the test results of the same control material probably due to personal factors of the institution. 4. Workshops titled "Quality control of Immunoassay" and " Quality control of tumor markers" were held on September 5, 2008 and December 3, 2008 in cooperation with Annual Autumn Academic Conferences of Clinical laboratory and Quality Control and Immunoserology Subcommittee. The quality of the participating laboratories seems to be thought being continuously improved. And, this year, about 51 laboratories are newly participated to our Immunoassay Subcommittee.

New Fiduciary Plate and Orientation Marker for High Energy Radiation Therapy / 대한방사선종양학회지

PURPOSE: A new fiduciary plate and orientation marker have been devised to assist the quality assurance (QA) procedures for port films in radiation therapy department. The plate is used in conjunction with the film/cassette combination during weekly QA procedures, at Seoul National University Hospital (SNUH), in order to verify treatment fields in high energy radiation therapy. MATERIALS AND METHODS: A new fiduciary plate was fabricated using an acrylic plate, cerrobend, standard blocking tray and mercury. The acrylic plate had the dimension of 1x25x25 cm, with two fiduciary markers. The plate was rigidly attached onto the standard blocking tray, thus making it easier to set the fiduciary plate to the center of the radiation field of the linear accelerator. The plate had two 2-mm vertical and horizontal lines, with the minor scales in 2-cm steps. The orientation marker was a small mercury filled disk, which was inserted into the plate. RESULTS: The geometrical structure of the lines in the plate makes it easier to correlate two different images between the simulation and port films. The marker clearly indicated the orientation of the film, for example, the anterior, posterior, left, right and various oblique orientations, without the placement of a conventional orientation marker. Also, the new orientation marker could easily be applied to the simulator by placing the small orientation marker onto the image intensifier or in front of the film/cassette holder. CONCLUSIONSs: The new fiduciary plate appears to be useful in verifying the treatment fields, and the new orientation marker makes the film orientation simple, which is expected to lower the block fabrication errors.

Review and Discussion of QA Detection of Modern Medical Equipment / 医疗卫生装备

The history of QA detection in the modern medical equipment which evolves in at home and PLA's hospital are reviewed, the detection works and some derived achievements in which the QA detection center of the wide-scale medical equipment of whole armed forces in past 10 years are introduced to discuss the problems in the QA detection of the modern medical equipment.