37.12.336    QUALITY ASSURANCE

(1) A licensed laboratory must develop and implement a quality assurance program that is an integrated system of activities involving planning, quality control, quality assessment, reporting, and quality improvement to ensure that its services meet its standards of quality with its stated level of confidence.

(2) The quality assurance program must address the type of testing activities the licensed laboratory undertakes and how quality assurance activities may change with changes in sample volumes. The quality assurance program must include a quality assurance plan and documentation of quality assurance activities.

(3) As part of its quality assurance program, each licensed laboratory must develop and adhere to a quality assurance plan. The laboratory must include and address the following essential items in the quality assurance plan:

(a) listing of key individuals, laboratory organization and lines of responsibility;

(b) position descriptions;

(c) evaluation of staff competency;

(d) staff training;

(e) general quality control procedures;

(f) frequency of proficiency testing;

(g) proficiency testing audit handling;

(h) reporting of proficiency testing results;

(i) analytical methods and SOPs with annual reviews and dates of revisions of the methods and SOPs;

(j) sample handling procedures;

(k) data reduction, validation, reporting, and verification (an SOP may be referenced);

(l) record keeping, quality assurance review of data, and reporting of results;

(m) equipment operation and calibration;

(n) physical facility factors that may affect quality;

(o) corrective action policy and procedures;

(p) definitions of terms used in the quality assurance plan;

(q) frequency and procedure of quality reviews and the content of reports to the laboratory director; and

(r) frequency, procedure, and documentation of preventive maintenance.

(4) For chemistry laboratories the plan must also include:

(a) calibration procedures for chemistry (an SOP may be referenced);

(b) instrument performance checks;

(c) laboratory reagent blanks, and field or trip blanks;

(d) field or laboratory matrix replicates;

(e) reference samples;

(f) laboratory fortified blanks and laboratory fortified matrix spikes;

(g) initial demonstration of method capability and use of control charts; and

(h) qualitative identification and confirmation of contaminants.

(5) As part of the quality assurance program, the laboratory must document and retain records for a period of five years demonstrating that it has maintained compliance with its quality assurance program. The laboratory may be requested by the department to provide quality assurance data to monitor compliance.

History: 50-1-202, MCA; IMP, 50-1-202, 75-6-106, MCA; NEW, 1999 MAR p. 291, Eff. 2/12/99; AMD, 2011 MAR p. 2286, Eff. 10/28/11.