Note: The language below was abstracted from Sections 2.4 and 2.5 of the 2003 NELAC Standard.
2.4 LABORATORY ENROLLMENT IN PROFICIENCY TESTING PROGRAM(S)
Required Level of Participation
To be accredited initially and to maintain accreditation, a laboratory shall participate in two single-blind, single-concentration PT studies, where available, per year for each field of proficiency testing for which it seeks or wants to maintain accreditation. Laboratories must obtain PT samples from a PTPA-approved PT Provider. Each laboratory shall participate in at least two PT studies for each field of proficiency testing per year unless a different frequency for a given program is defined in the appendices.
Requesting Accreditation
At the time each laboratory applies for accreditation, it shall notify the Accreditation Body which field(s) of testing it chooses to become accredited for and shall participate in the appropriate PT studies. For all fields of proficiency testing, including those for which PT samples are not available, the laboratory shall ensure the reliability of its testing procedures by maintaining a total quality management system that meets all applicable requirements of Chapter Five of the NELAC standards.
Reporting Results
Each laboratory shall authorize the PT Provider to release all accreditation and remediation results and acceptable/not acceptable status directly to the Primary Accreditation Body, and the PTPA, in addition to the laboratory.
2.5 REQUIREMENTS FOR LABORATORY TESTING OF PT STUDY SAMPLES
The samples shall be analyzed and the results returned to the PT Provider no later than 45 calendar days from the opening of the study (i.e., first day that samples are shipped or available to laboratories. The laboratory's management and all analysts shall ensure that all PT samples are handled (i.e., managed, analyzed, and reported) in the same manner as real environmental samples utilizing the same staff, methods as used for routine analysis of that analyte, procedures, equipment, facilities, and frequency of analysis. When analyzing a PT sample, a laboratory shall employ the same calibration, laboratory quality control and acceptance criteria, sequence of analytical steps, number of replicates and other procedures as used when analyzing routine samples.
Restrictions on Exchanging Information
Laboratories shall comply with the following restrictions on the transfer of PT samples and communication of PT sample results prior to the time the results of the study (routine or supplemental studies) are released:
a) A laboratory shall not send any PT sample, or a portion of a PT sample, to another laboratory for any analysis for which it seeks accreditation, or is accredited;
b) A laboratory shall not knowingly receive any PT sample or portion of a PT sample from another laboratory for any analysis for which the sending laboratory seeks accreditation, or is accredited;
c) Laboratory management or staff shall not communicate with any individual at another laboratory
(including intracompany communication) concerning the PT sample; and
d) Laboratory management or staff shall not attempt to obtain the assigned value of any PT sample from their PT Provider.
Maintenance of Records
The laboratory shall maintain copies of all written, printed, and electronic records, including but not limited to bench sheets, instrument strip charts or printouts, data calculations, and data reports, resulting from the analysis of any PT sample for five years or for as long as is required by the applicable regulatory program, whichever is greater. These records shall include a copy of the PT study report forms used by the laboratory to record PT results. All of these laboratory records shall be made available to the assessors of the Accreditation Body during on-site audits of the laboratory.
