Shanghai center for clinical laboratory is a technical support unit authorized by the Shanghai municipal health commission to conduct quality supervision, guidance and service on clinical laboratories of medical institutions throughout the city. Its predecessor was a small health laboratory under the Public Concession Works Bureau, which was founded in 1871. In 1926, it became Shanghai public health laboratory institute (later renamed as Health laboratory institute under Shanghai municipal health bureau).
In 1953, based upon the food hygiene and drug inspections function, the institution was separated into Shanghai health and epidemic prevention station, and Shanghai institute of drug control, while the function of biological products inspection was incorporated into the Shanghai research 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 research institute of biological products. The Shanghai medical laboratory was restored in January 1979. In 1984 it became a collaborating center for reagent production of WHO. In August 1985 it was renamed as Shanghai center for clinical laboratory (SCCL). The Shanghai clinical laboratory quality control center was founded in January 1999, making it one of the earliest professional quality control centers in Shanghai. The center is located at No. 528 Hongshan Road, Pudong New Area, Shanghai. It has a total area of 9932 m², with the ground area of 7510 m².
The center currently has 121 staffing，among which 1 is a PhD tutor, 2 are master tutor, 45 of them hold a master degree or above and 22 own senior professional title. 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 magazine editorial department of "Laboratory Medicine", Shanghai yihua medical technology co., ltd. are directly attached to the center.
After the clinical laboratories quality management system (guideline 25) established by SCCL was first approved by the Chinese national accreditation board for laboratories (CNAL) in June 2002, in 2004 it became known as ISO17025 and has been improved continuously ever since. In February 2017, it passed the re-evaluation of the Chinese national accreditation service for conformity assessment (CNAS) and maintained its technical capability of 72 testing items.
In November 2011, the center was accredited by the International federation of clinical chemistry and laboratory medicine (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 first-level reference laboratory of testing in China.
In September 2012, the PTP Quality Management System (ISO17043) established by the center was first accredited by CNAS. In March 2016, it past re-evaluation. 295 inter-laboratory quality assessment projects were conducted in 2016, among them 118 are accredited projects and additional accreditations are being applying.
In October 2013, the reference measurement laboratory quality management system (ISO15195) established 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 supplemented 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, with 9 items in total including creatine kinase (CK), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP) and namely creatinine (Cr) and glycated hemoglobin.
SCCL is the practice center for Shanghai jiaotong university school of medicine and cooperates with Shanghai university of medicine & health sciences. It is also the leading unit of "East China inspection talent training alliance".
Since 2011, the center has won the honorary title of "Shanghai civilized unit" for three consecutive years.