310 CMR, § 42.07 - Criteria for Certification

(1) Proficiency Testing. Satisfactory performance in the proficiency testing program is accomplished when the analytes in a category are correctly identified and acceptably quantified. Criteria for acceptability shall be set by the Department for each analyte in each discipline and category. Continued unsatisfactory performance in the analysis of an analyte within a category may result in revocation of certification for that analyte.

(2) Inspections.

(a) The Department may conduct an inspection of each laboratory to determine whether or not the laboratory meets the Department's standards for performing analyses in the matrices, disciplines, and categories for which certification is sought or is obtained.

(b) The Department shall consider the following factors in determining whether to certify or continue certification of a laboratory:

1. Education and experience of laboratory personnel;

2. Adequacy of laboratory facilities and equipment;

3. Adherence to Department-approved methodology and quality assurance/quality control procedures;

4. Adherence to Department-approved methods of handling and reporting data;

5. Adequacy of safety equipment and training; and

6. Any other factors the Department deems relevant to the determination of the ability of a laboratory to operate in a professional manner.

(c) If the Department issues a report of deficiencies found during an inspection of a laboratory, the laboratory shall have 90 days from the date of issuance of the report to take the necessary corrective actions specified in the report and submit documentation of such corrective action to the Department.

Notes

310 CMR, § 42.07

Amended by Mass Register Issue 1325, eff. 11/4/2016.