Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4740 - LABORATORIES; ACCREDITATION REQUIREMENTS
Part 4740.2087 - SAMPLE HANDLING, RECEIPT, AND ACCEPTANCE
Universal Citation: MN Rules 4740.2087
Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1. Handling samples.
A. A laboratory must have procedures for the
transportation, receipt, handling, protection, storage, retention, and disposal
of samples. The procedures must include provisions necessary to protect the
integrity of the sample and to protect the interests of the laboratory and the
client.
B. A laboratory must have a
system for identifying samples. The sample's identification must be retained
throughout the life of the sample in the laboratory. The identification system
must be designed and operated so as to ensure that samples cannot be confused
physically or when referred to in laboratory documentation. The identification
of samples must accommodate a subdivision of groups of samples and the transfer
of samples between laboratories.
C.
Upon receipt of samples, the condition, including any abnormalities or
departures from specified conditions as described in the laboratory's quality
assurance manual, must be recorded. When there is doubt as to the suitability
of a sample for environmental testing, when a sample does not conform to the
description provided, or when the environmental test required is not specified
in sufficient detail, the laboratory must consult the client for further
instructions before proceeding and must maintain a written record of the
discussion.
D. When an insufficient
amount of sample is received, a laboratory may choose to subsample if
subsampling would not cause loss of sample integrity. Information concerning
the insufficient amount of sample and any decision to subsample must be
indicated with the test results.
E.
A laboratory must have procedures and appropriate facilities for avoiding
deterioration, contamination, loss, or damage to the sample during storage,
handling, preparation, and testing.
F. When samples require storage under
specified environmental conditions, the conditions must be maintained,
monitored, and recorded. When a sample or a portion of a sample is to be held
secure, a laboratory must have arrangements for storage and security that
protect the condition and integrity of the secured samples or portions
concerned.
G. Samples, sample
fractions, extracts, leachates, and other products of sample preparation must
be kept in storage units, such as cabinets, refrigerators, or freezers, that
are separate from the storage units for all standards, reagents, food, and
other potentially contaminating sources. Samples must be stored in such a
manner to prevent contamination between samples.
Subp. 2. Sample receipt protocols.
The following items must be verified and the results documented:
A . all samples that
require chemical preservation are considered acceptable if the laboratory
verifies that the preservation meets the requirements of the approved method. A
laboratory must implement procedures for checking chemical preservation before
sample preparation or analysis except for methods where postanalysis
preservation checks are required to ensure that sample integrity is not
compromised. When specified in permit, program, or rule, chemical preservation
must be verified upon receipt; and
B. a laboratory must maintain chronological
records, either paper-based or electronic, such as a log book or database, to
document receipt of all samples, including the number and types of containers
received for each field of testing. The records must include:
(1) the client and project name, if
applicable;
(2) the date and time
of laboratory receipt;
(3) a unique
laboratory-assigned identification code;
(4) the signature, initials, or equivalent
electronic identification of the person making the entries;
(5) the field identification code, which
identifies each container, linked to the laboratory-assigned identification
code in the sample receipt log;
(6)
the date and time of sample collection, linked to the sample container and to
the date and time of receipt in the laboratory;
(7) the requested field of testing, linked to
the laboratory-assigned identification code; and
(8) any comments resulting from inspection
for sample rejection, linked to the laboratory-assigned identification
code.
Subp. 3. Sample acceptance policy.
A. A laboratory must have a written sample
acceptance policy that clearly outlines the circumstances under which samples
will be accepted or rejected by the laboratory. Data from samples that do not
meet the laboratory's criteria must be recorded in an unambiguous manner
clearly defining the nature and substance of the deviation from acceptable
procedures.
B. A laboratory's
sample acceptance policy must be made available to sample collection personnel
and must address, at a minimum:
(1)
documentation, including sample identification; location, date, and time of
collection; collector's name; preservation type; sample type; and any special
remarks concerning the sample;
(2)
sample labeling, to include unique identification, and a labeling system for
the samples with requirements concerning the durability of the labels (water
resistant) and the use of indelible ink;
(3) use of appropriate sample
containers;
(4) adherence to
specified holding times;
(5)
adequate sample volume to perform the requested tests and relevant quality
control determinations; and
(6)
procedures to be used when samples show signs of damage, contamination,
inadequate preservation, or loss of integrity.
C. If the sample does not meet the sample
receipt acceptance criteria listed in the laboratory's quality assurance
manual, the laboratory must retain correspondence and records of conversations
concerning the final disposition of rejected samples or fully document any
decision to proceed with the analysis of samples not meeting acceptance
criteria. The report of samples analyzed without meeting the sample acceptance
criteria must indicate, at a minimum, the condition of the samples on the
chain-of-custody, transmittal form, or the laboratory receipt documents in
addition to appropriately qualifying the analysis data on the final
report.
Statutory Authority: MS s 144.97; 144.98
Disclaimer: These regulations may not be the most recent version. Minnesota may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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