Code of Maine Rules › 10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES › 144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL › Chapter 263 - MAINE COMPREHENSIVE AND LIMITED ENVIRONMENTAL LABORATORY ACCREDITATION RULE › Section 144-263-9 - LABORATORY POLICIES AND PROCEDURES

Current through 2024-29, July 17, 2024
A.
Quality assurance manual
1. A
				laboratory must possess and follow a written manual of quality
				assurance.
2. The manual may
				include separate procedures or incorporate documents by reference.
3. The manual or its separate procedures must
				contain the following:
a. Document
				title;
b. Identification on each
				page to ensure that the page is recognized as part of the manual and clear
				identification of the end of the manual;
c. The laboratory's name and
				address;
d. Identification of the
				laboratory's approved signatories;
e. A revision number;
f. A date indicating when the revision became
				effective;
g. A table of contents,
				applicable lists of references, glossaries and appendices;
h. All maintenance, calibration and
				verification procedures used by the laboratory in conducting tests;
i. Major equipment, support equipment and
				reference measurement standards (e.g., NIST traceable thermometers and
				weights);
j. Verification
				practices, which may include proficiency testing programs, use of reference
				materials, internal QC processes and inter-laboratory comparisons;
k. Procedures for reporting analytical
				results;
l. The organization and
				management structure of the laboratory, its place in any parent organization
				and relevant organizational charts;
m. Procedures to ensure that all records
				required under this rule are retained, as well as procedures for control and
				maintenance of documentation through a document control system that ensures
				that all SOPs, manuals or documents clearly indicate the time period during
				which the procedure or document was utilized;
n. Job descriptions of key staff and
				reference to the job descriptions of other laboratory staff;
o. Procedures for achieving traceability of
				measurements;
p. A list of all
				methods under which the laboratory performs its accredited or provisionally
				accredited testing;
q. Procedures
				for ensuring that the laboratory reviews all new work to ensure that it has the
				appropriate facilities and resources before commencing such work;
r. Procedures for handling samples, including
				subcontract testing;
s. Procedures
				for collection and transportation of samples, if the laboratory provides this
				service;
t. Procedures to be
				followed for feedback and corrective action whenever testing discrepancies are
				detected or departures from documented policies and procedures occur;
u. Policy for permitting departures from
				documented policies and procedures or from standard specifications;
v. Procedures for handling
				complaints;
w. Procedures for
				protecting confidentiality (including national security concerns) and
				proprietary rights;
x. Procedures
				for data review to include both technical review for accuracy, as well as a
				careful review for accuracy regarding transcription or other errors in
				reporting;
y. Procedures for
				internal audits;
z. Procedures for
				establishing that personnel are adequately experienced in the duties they are
				expected to carry out, as well as procedures for providing necessary
				training;
aa. A policy addressing
				the use of unique electronic signatures, where applicable; and
bb. A description of how data accuracy and
				precision are determined for each accredited method and analyte within each
				test category; for example, establishing control limits, preparing control
				charts and performing calculations.
4. The manual must be reviewed periodically
				and updated when necessary. Documentation of the review process must include
				the scope of the review, identification and signature of the reviewer, as well
				as the date the review was completed.