Iowa Administrative Code
Agency 641 - Public Health Department
Chapter 154 - Medical Cannabidiol Program
Rule 641-154.52 - Recordkeeping Requirements
Universal Citation: IA Admin Code 641-154.52
Current through Register Vol. 47, No. 6, September 18, 2024
(1) Data package. A laboratory shall create a data package for each analytical batch of primary samples that the laboratory analyzes. The data package shall contain at minimum the following information:
a. The name and address of the laboratory
that performed the analytical procedures;
b. The names, functions, and signatures
(electronic or handwritten) of the laboratory personnel who performed the
primary sample preparation, analyzed the primary samples, and reviewed and
approved the data;
c. All primary
sample and analytical batch quality control sample results;
d. Raw data for each primary sample
analyzed;
e. Instrument raw data,
if any was produced;
f. Instrument
test method with parameters;
g.
Instrument tune report, if one was created;
h. All instrument standard calibration
data;
i. Test-method worksheets or
forms used for primary sample identification, characterization, and
calculations, including chromatograms, sample-preparation worksheets, and final
datasheets;
j. The quality control
report with worksheets, forms, or copies of laboratory notebook pages
containing pertinent information related to the identification and traceability
of all reagents, reference materials, and standards used for
analysis;
k. The analytical batch
sample sequence;
l. The field
sample log; and
m. The
chain-of-custody form.
(2) Review of data package. After the laboratory has compiled a data package, an individual at the laboratory who was not previously involved in the creation of the data package shall:
a. Assess the analytical results for
technical correctness and completeness;
b. Verify that the results of each analysis
carried out by the laboratory are reported accurately, clearly, unambiguously,
and objectively;
c. Verify that the
measurements can be traced back; and
d. Approve the measurement results by signing
and dating the data package prior to release of the certificate of analysis by
the laboratory.
(3) Data package record retention. The entire data package shall be stored by a laboratory for a minimum of five years and shall be made available upon request by the department or the requester of the laboratory testing.
(4) Other records. A laboratory shall maintain all documents, forms, records, and standard operating procedures associated with the testing of medical cannabidiol.
a. A laboratory shall maintain
analytical testing laboratory records in such a manner that the analyst, the
date the analysis was performed, the approver of the certificate of analysis,
the reviewer and approver of the data package, the test method, and the
materials that were used can be determined by the department.
b. Records shall be stored in such a way that
the data may be readily retrieved when requested by the department.
c. All testing laboratory records shall be
kept for a minimum of five years, unless otherwise noted in these
rules.
d. The department shall be
allowed access to all electronic data, including standards records, calibration
records, extraction logs, and laboratory notebooks.
e. A laboratory shall keep and make available
to the department the following records related to the testing of medical
cannabidiol:
(1) Personnel qualification,
training, and competency documentation, including but not limited to
résumés, training records, continuing education records,
analytical proficiency testing records, and demonstration of competency records
for laboratory work. These records shall be kept current.
(2) Method verification and validation
records, including method modification records, method detection limit and
quantitation limit determination records, ongoing verification records such as
proficiency test records and reference material analysis records.
(3) Quality control and quality assurance
records, including the laboratory's quality assurance manual and control charts
with control limits.
(4)
Chain-of-custody records, including chain-of-custody forms, field sample logs,
sample-receipt records, sample-description records, sample-rejection records,
laboratory information management system records, sample-storage records,
sample-retention records, and disposal records.
(5) Purchasing and supply records,
equipment-services records, and other equipment records, including purchase
requisition records, packing slips, supplier records, and certificates of
analysis.
(6) Laboratory equipment
installation records, maintenance records, and calibration records. These
records shall include the date and name of the person performing the
installation of, calibration of, or maintenance on the equipment, with a
description of the work performed, maintenance logs, pipette calibration
records, balance calibration records, working and reference mass calibration
records, and daily verification-of-calibration records.
(7) Customer service records, including
customer contracts, customer requests, certificates of analysis, customer
transactions, customer feedback, records related to the handling of complaints
and nonconformities, and corrective action pertaining to complaints.
(8) Nonconforming work and corrective action
records, including corrective action, nonconformance, nonconformities resolved
by correction, customer notification of nonconformities, internal
investigations, implementation of corrective action, and resumption-of-work
records.
(9) Internal-audit and
external-audit records, including audit checklists, standard operating
procedures, and audit observation and findings reports. These records shall
include the date and name of the person performing the audit.
(10) Management review records, including
technical data review reports and final management-review reports. These
records shall include the review date and the name of the reviewer.
(11) Laboratory data reports, data review,
and data approval records, including instrument and equipment identification
records, records with unique sample identifiers, analysts' laboratory notebooks
and logbooks, traceability records, test-method worksheets and forms,
instrumentation-calibration data, and test-method raw data. These records shall
include the analysis date and the name of the analyst.
(12) Proficiency testing records, including
the proficiency test schedule, proficiency tests, data-review records,
data-reporting records, nonconforming work and corrective actions, and quality
control and quality assurance records related to proficiency testing.
(13) Electronic data, backed up data, records
regarding the protection of data, including unprocessed instrument output data
files and processed quantitation output files, electronic data protocols and
records, and authorized personnel records.
(14) Security data, including
laboratory-security records and laboratory-access records,
surveillanceequipment records, and security-equipment records. These records
shall be stored for at least one year.
(15) Traceability, raw data, standards
records, calibration records, extraction logs, reference materials records,
analysts' laboratory notebooks and logbooks, supplier records, and certificates
of analysis, and all other data-related records.
(16) Laboratory contamination and cleaning
records, including autoclave records, acid-wash logs and records, and general
laboratory-safety and chemical-hygiene protocols.
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