2015年 · 第95卷第12期

With the rapid development of science and technology, clinical laboratory testing instruments and methods have made revolutionary progress, but the satisfaction of the service objects-clinical medical care and patients has not fundamentally changed. This makes laboratory workers begin to think and seek a scientific management method to continuously improve the quality of laboratory test results to meet the increasing needs of customers. International standards such as the International Organization for Standardization (ISO) and the American Society of Pathologists (CAP) are constantly coming into our field of vision. In particular, the National Health and Family Planning Commission officially promulgated the Administrative Measures for Clinical Laboratories in Medical Institutions on June 1, 2006, which clearly defines the definition of medical laboratory as "a laboratory that performs hematology, biology, chemistry, microbiology, biophysics, immunology, blood immunology, cytology and other tests on various specimens taken from the human body, and provides clinical medical testing services". Article 20 stipulates that "clinical laboratories of medical institutions shall provide interpretation and consultation services of clinical test results". This change has changed the working orientation and concept of medical laboratories^[1]It also makes clinical laboratory managers start to look at the quality assurance measures of clinical test results from a systematic perspective and formulate overall solutions. Regardless of the standard selected, or to meet the basic requirements of the Administrative Measures for Clinical Laboratories in Medical Institutions, a comprehensive quality management system must first be established-that is, the core of inspection quality assurance, and effectively operated and continuously improved. The construction of medical laboratory quality management system has been implemented internationally for many years. It has been proved by practice that it has played a very positive role in standardizing laboratory management, ensuring the quality of inspection results and improving the quality of personnel^[2]。 According to the present situation of quality management in medical laboratories, solve the problems existing in quality management, and guide medical laboratories to carry out quality management more systematically and scientifically, so as to promote the continuous improvement of service quality and enhance the core competitiveness of medical laboratories^[3,4]。

The annual San Antonio Breast Cancer Conference (SABCS) was held as scheduled from December 9 to 13, 2014. The event brought together 8,000 scholars from more than 90 countries and regions around the world to share the annual feast in the field of breast cancer diagnosis and treatment. The conference announced important research results in the fields of basic breast cancer medicine, translational medicine, adjuvant treatment of early breast cancer and treatment of advanced breast cancer, which are here to share and discuss with you.

Clinical biochemistry (hereinafter referred to as biochemistry) tests are of great significance for the diagnosis and outcome of diseases. With the development of medical career, clinicians have put forward higher requirements for obtaining accurate test results. However, compared with the practice of applying supporting systems to ensure the traceability and comparability of measurement abroad, the common coexistence of supporting systems and non-supporting systems in China makes many laboratories unable to effectively guarantee the traceability of measurement. Metrological traceability refers to the characteristic of linking a measurement result or value of a measurement standard to a prescribed reference standard, usually a national standard or an international standard, through an uninterrupted chain of comparison with a prescribed degree of uncertainty^[1]。 Non-supporting system, also called self-built system in China^[2]That is, the laboratory selects calibrators, instruments, reagents, testing procedures and other components from different sources to establish a testing system. However, the self-built system cannot maintain the metrological traceability of the original system, which affects the consistency of biochemical test results between different systems and different laboratories. Therefore, how to improve the accuracy of inspection results, especially the accuracy of non-supporting system inspection results, so as to better ensure the inspection quality and comparability of results is a realistic problem faced by many medical institutions.

Thyroid cancer is the most common malignancy of the endocrine system, accounting for the first place in head and neck malignancies, accounting for about 3% of all malignancies, and has a high incidence in women. Thyroid cancer includes papillary thyroid cancer, follicular thyroid cancer, undifferentiated thyroid cancer, and medullary thyroid cancer. In recent years, the incidence of thyroid cancer in China has been increasing year by year. Although the overall death rate from thyroid cancer has remained flat, the absolute number of deaths from thyroid cancer each year is rising. With the increasing incidence of thyroid cancer, researchers pay more and more attention to the basic research of thyroid gland. In recent years, great progress has been made in the research on the mechanism of thyroid cancer. However, at present, the deeper basic research on thyroid cancer is still being explored, so the following hot issues are listed for discussion and research.

The American Society for Clinical and Laboratory Standardization (CLSI) has been working to develop a series of documents for evaluating clinical testing methods. It adopts a unique consensus process in developing relevant standards and guidelines, including the establishment, endorsement and publication of protocols, extensive, detailed and comprehensive commentary on relevant documents, and revision of documents based on user comments to ensure their adaptability, etc^[1]。 CLSI first introduced EP9-P (proposed guideline) in January 1986, EP9-T (tentative guideline) in April 1993, and then revised EP9-A (approved guideline) in December 1995^[2]。 Subsequently, it was revised three times, namely EP9 – A2 of September 2002^[3]EP9 – A2 – IR (interim revision), July 2010, and the latest version EP9 – A3, August 2013^[4], namely, Method Alignment and Offset Assessment with Patient Samples: Approved Guidelines – Third Edition, EP9 – A3 provides manufacturers and clinical laboratories with the latest methodological alignment and offset assessment guidelines. The author will briefly introduce its basic structure, main uses, comparison requirements, experimental scheme, statistical methods and other contents for peers' reference.

sodium pyruvate has not been used in clinic except for a few clinical trials. Because it has many excellent biological characteristics such as improving cellular hypoxia tolerance, it is suitable for clinical prevention and treatment of hypoxic lactic acidosis (LA). It has important theoretical significance and application value in critical care medicine.

Trauma, burns, abnormal pigmentation and scars are common skin lesions, which cause great physical pain, mental stress and economic burden to patients. How to restore the normal shape and function of damaged skin is one of the common problems faced by burns, cosmetology and plastic surgery. Autologous skin grafting has always played an important role in the repair of skin defects. With the advancement of medical science and technology, a new technology – ReCell^®Cell autologous in vitro regeneration technology (hereinafter referred to as ReCell^®Technology) has been widely used in skin wound repair in the fields of burn, cosmetology, plastic surgery and other fields because of its characteristics that autologous skin cell suspension can be obtained without culture, and has achieved certain results, which are summarized below.

Myelodysplastic syndromes (MDS) are a group of highly heterogeneous malignant clonal diseases of the hematopoietic system that involve abnormal changes in multiple genes in multiple steps. The main manifestations are abnormal development of one or more lines of myeloid cells of bone marrow, ineffective hematopoiesis leading to refractory anemia or pancytopenia and increased risk of evolving into acute myeloid leukemia^[1]。 The 2008 WHO hematological tumor classification system classified MDS as one of the five major categories of myeloid tumors. Since the 1990s, the incidence of MDS has been increasing significantly, especially in people over 70 years old. The annual incidence of MDS has increased from (2~12) to (30~50) /100 000, much higher than that of acute myeloid leukemia (AML) and myeloproliferative tumors (MPN)^[2]。 Therefore, the understanding and in-depth research of MDS is increasingly important.