Current through Register Vol. 49, No. 13, September 23, 2024
A. A
laboratory must possess and follow a written manual of quality
assurance.
B. The manual may
include several separate procedures or incorporate documents by
reference.
C. The manual or its
separate procedures must contain:
(1)
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;
(2) the laboratory's name;
(3) a revision number; and
(4) a date indicating when the revision
became effective.
D. The
manual must be reviewed periodically and updated when necessary. Documentation
of the review process must include the scope of the review, identification of
the reviewer, and the date the review was completed.
E. At the time of application, a laboratory
must submit a copy of the manual, including documents incorporated by reference
if these documents are not generally available to the commissioner. Each
subsequent revision of the manual or any of its separate procedures must be
submitted to the commissioner in its entirety no later than 30 days after the
effective date of the revision.
F.
Unless a laboratory justifies why an item is not applicable, the manual must
incorporate the quality assurance practices described in parts 4740.2087 and
4740.2089, including but not limited to policies and procedures used to:
(1) determine continual compliance with parts
4740.2010 to 4740.2120;
(2) collect
and transport samples, including containers and preservatives according to part
4740.2087, subpart 1;
(3) track
samples from the time the laboratory receives them through the time the samples
are disposed, including chain-of-custody procedures for samples requested to be
processed for possible legal action according to parts 4740.2087, subparts 2
and 3; and 4740.2097;
(4) track the
purity and acceptability of laboratory standards and reagents, including the
laboratory's source of reagent grade water according to part
4740.2089;
(5) maintain functional
equipment, including routine maintenance performed and scheduled according to
parts 4740.2091, subpart 2; and 4740.2093, subpart 2;
(6) determine data accuracy and precision for
each certified method and analyte within each test category, for example,
establishing control limits, preparing control charts, and performing
calculations, according to the applicable provisions of parts 4740.2100 to
4740.2120;
(7) validate data
conversion, transcription, and reporting according to part 4740.2095;
(8) accept or reject samples according to
part 4740.2087, subpart 3;
(9)
correct unacceptable proficiency testing results according to part 4740.2070,
subparts 9 and 10, or perform quality control checks according to the
applicable provisions of parts 4740.2087 to 4740.2120;
(10) record changes in training and education
of laboratory personnel, including on-the-job training relevant to analysis and
reporting of results according to part 4740.2099;
(11) subcontract testing; and
(12) address client complaints.
G. A laboratory must routinely
evaluate and document the effectiveness of its quality system to ensure that
requirements for certification in parts 4740.2010 to 4740.2120 are
met.
