Shanghai clinical laboratory center is a technical support unit authorized by the Shanghai municipal health and family planning commission to conduct quality supervision, guidance and service in clinical laboratories of medical institutions throughout the city. Its predecessor was a small health laboratory under the public works ministry, which was founded in 1871. In 1926, it became Shanghai public health institute (later renamed as Health laboratory institute under Shanghai municipal health bureau).
In 1953, based upon the food hygiene and drug testing inspections, the institution was separated into Shanghai health and epidemic prevention bureau, and Shanghai institute of drug control, while the task of biological products testing was incorporated into the Shanghai institute of biological products. In January 1954, the medical examination part was merged with several private laboratories to establish the Shanghai medical laboratory. 1955 saw the set up of the Central blood bank. In 1971, the medical testing department merged into the Shanghai sixth people's hospital, and the central blood bank merged into the Shanghai institute of biological products. The Shanghai medical laboratory was restored in January 1979. In 1984 it became a collaborating center for reagent production of the WHO. In August 1985 it was renamed as Shanghai centre for clinical laboratory (SCCL). The Shanghai clinical laboratory quality control centre was founded in January 1999, thus making it one of the earliest and most professional quality control centers in Shanghai. The center is located on Hongshan Road, Pudong New Area, No. 528. It has a total area of 9932m2, with the ground area of 7510m2.
The center currently employs 121 staff members among whom 97 are regular employees, 1 is a PhD supervisor, 2 are masters supervisors, 45 of them hold a masters degree or above and 22 are high-ranking technical professionals. Up until now, a total number of six senior experts have been receiving special allowances from the State Council. The center has 15 departments performing either administrative or professional duties. The Shanghai Yihua medical technology Co., Ltd. editorial department, "Laboratory Medicine", is directly attached to the center.
After SCCL had created the clinical laboratories quality management system (guideline 25) in June 2002, it was approved by the Chinese national accreditation board for laboratories (CNAL), and in 2004 it became known as ISO 17025 and has been improved continuously ever since. In February 2017, it passed the re-evaluation control of the Chinese national accreditation service for conformity assessment (CNAS) and maintains its technical capability of 72 testing items.
In November 2011, the center was accredited by the International union for clinical chemistry (IFCC) and was formally established as first-level reference laboratory for HbA1c. After the 12 laboratories in Europe, the United States and Japan, this is the first laboratory of its kind in developing countries and the first in reference testing laboratory in China.
In September 2012, the PTP Quality Management System (ISO17043) established by the center was first accredited by CNAS. In March 2016, it was re-evaluated and 295 inter-laboratory quality assessment projects were conducted in 2016, among them, 118 are accredited projects and are now applying for additional accreditation.
In October 2013, the reference measurement laboratory quality management system (ISO15195) created by the center was accredited for the first time by CNAS. The 7 accredited enzymatic items are: alanine aminotransferase (ALT), aspartate aminotransferase (AST), α-amylase (AMY), creatine kinase (CK), γ-glutamyl transferase (GGT), lactate dehydrogenation enzyme (LDH), and alkaline phosphatase (ALP). After the re-evaluation in February 2017, the list was completed with 2 more items, namely creatinine (Cr) and glycated hemoglobin.
In August 2017, the center became member of JCTLM. The center was formally approved by JCTLM, and the list of items continued to grow, now including creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH) , gamma glutamyltransferase (GGT),alkaline phosphatase (ALP) and namely creatinine (Cr) and glycated hemoglobin ,a total amount of 9.
SCCL is the practice center for Shanghai Jiaotong university school of medicine and cooperates with Shanghai health medical college. It is also the "East China talent training alliance" leading unit.
Since 2011, the center has won the honorary title of "Shanghai cultural unit" for three consecutive years.