Abstract:

Objective To study the status of PTP system in laboratory medicine,through collecting and analyzing the nonconformities during the assessment of proficiency testing provider（PTP）accreditation in laboratory medicine. Methods The nonconformities during the assessment of PTP accreditation in laboratory medicine were collected and categorized according to the criteria of PTP accreditation （CNAS CL-03）. The occurrence frequency of nonconformities was calculated and compared. Results There were 68 nonconformities in 11 on-site assessments against the criteria of PTP accreditation,involving 15 clauses of CNAS CL-03. Among them,76.0% was against technical requirements,and 24.0% was against management requirements. For technical requirements,nonconformities were most frequently reported against Clause 4.2（personnel）,4.4（proficiency testing scheme）,4.6（proficiency testing operation scheme） and 4.7（datum analysis and result evaluation）.For management requirements,nonconformities were most frequently reported against Clause 5.1（organization）. Conclusions The most frequently found nonconformities are Clause 4.2,4.4,4.6 and 4.7,which are the main directions needed to be focused to establish, develop and improve the quality management system of PTP in laboratory medicine.

Key words: Proficiency testing provider, Accreditation, Laboratory medicine