5 Colo. Code Regs. § 1005-7-9

Current through Register Vol. 47, No. 24, December 25, 2024

Rule 5 CCR 1005-7-9 - [Effective 1/14/2025] Natural Medicine Testing Facilities: Quality Assurance and Quality Control

9.1Quality Assurance Program Required. A Natural Medicine Testing Facility must establish, monitor, and document the ongoing review of a quality assurance program that is sufficient to identify problems in the laboratory preanalytic, analytic and postanalytic systems when they occur and must include, but is not limited to:

9.1.1 Review of instrument preventive maintenance, repair, and troubleshooting; Corrective Actions documentation must be performed by the laboratory director or designated quality assurance manager on an ongoing basis to ensure the effectiveness of actions taken over time;

9.1.2 Review by the Natural Medicine Testing Facility director or designated quality assurance manager of all ongoing quality assurance; and

9.1.3 Review of the performance of validated methods used by the Natural Medicine Testing Facility to include calibration standards, controls and the Standard Operating Procedures used for analysis on an ongoing basis to ensure quality improvements are made when problems are identified or as needed.

9.1.4 Review of Nonconformance reports at an appropriate specified frequency. Nonconforming work which is deemed high impact must be reviewed at least monthly until a resolution is reached and a root cause identified. High impact nonconforming work may include, but is not limited to, any situation in which the laboratory is in violation of the rules outlined herein or where the quality of the data released is impacted..

9.2Quality Control Measures Required. A Natural Medicine Testing Facility must establish, monitor and document on an ongoing basis the Quality Control measures taken by the Natural Medicine Testing Facility to ensure the proper functioning of equipment, validity of Standard Operating Procedures and accuracy of results reported. The Natural Medicine Testing Facility must ensure that appropriate quality assurance and Quality Control measures are performed and documented as necessary for the specific methodology. Such Quality Control measures must include, but shall not be limited to:

9.2.1 Documentation of instrument preventive maintenance, repair, troubleshooting and Corrective Actions taken when performance does not meet established levels of quality;

9.2.2 Review and documentation of the accuracy of automatic and adjustable pipettes and other measuring devices when placed into service and annually thereafter;

9.2.3 Cleaning, maintaining, verifying, and calibrating as needed the analytical balances and in addition, verifying the performance of the balance annually using certified weights to include three or more weights bracketing the ranges of measurement used by the Natural Medicine Testing Facility;

9.2.4 Annually verifying working thermometers against a certified reference thermometer. Certified reference thermometers shall be calibrated traceable to the SI (International System of Units) through NIST, or equivalent by an ISO/IEC 17025 accredited calibration laboratory with a listed certification date;

9.2.5 Recording temperatures on all equipment when in use where temperature control is specified in the Standard Operating Procedures, such as water baths, heating blocks, incubators, ovens, refrigerators, and freezers;

9.2.6 Properly labeling reagents as to the identity, the concentration, date of preparation, storage conditions, lot number tracking, expiration date and the identity of the preparer;

9.2.7 Avoiding mixing different lots of reagents in the same analytical run;

9.2.8 Performing and documenting a calibration curve with each analysis using at minimum five calibrators throughout the reporting range;

9.2.8.1 The laboratory shall not remove data points from within a calibration range while still retaining the extreme ends of the calibration range. If a calibration point fails, the laboratory must re-prepare and re-analyze the calibration standard;

9.2.8.2 The laboratory must use an appropriate curve-fitting algorithm (e.g. linear, quadratic, with or without weighing.) The acceptance criteria for concentrations of the calibration standards shall adhere to the recovery requirements outlined in Rule 7.10; and

9.2.8.3 The lowest calibration level shall not be greater than the applicable regulatory limit.

9.2.9 For qualitative analyses, analyzing, at minimum, a negative and a positive control with each batch of Samples analyzed;

9.2.10 For quantitative analyses, analyzing, at minimum, a negative and two levels of controls that challenge the linearity of the entire curve;

9.2.11 Using a control material or materials that differ in either source or, lot number, or concentration from the calibration material used with each analytical run;

9.2.12 For multi-Analyte assays, performing and documenting calibration curves and controls specific to each Analyte, or at minimum, one with similar chemical properties as reported in the analytical run;

9.2.13 Analyzing an appropriate Matrix blank and control with each analytical run, when available;

9.2.14 Analyzing calibrators and controls in the same manner as unknowns;

9.2.15 Documenting the performance of calibration standards and controls for each analytical run to ensure the Acceptability Criteria as defined in the Standard Operating Procedure is met;

9.2.16 Documenting all Corrective Actions taken when unacceptable calibration, control, and standard or instrument performance does not meet Acceptability Criteria as defined in the Standard Operating Procedure;

9.2.17 Maintaining records of validation data for any new or modified methods to include; accuracy, precision, analytical specificity (interferences), LOD, LOQ, and verification of the linear range;

9.2.18 Performing testing that follows the current Standard Operating Procedures for the test or tests to be performed;

9.2.19. The LOQ must be 50% of the limit or less for all Analytes within all assays;

9.2.20. Duplicate Sample results shall not exceed 30% relative percent difference (RPD); and

9.2.21. LOD and LOQ must be scientifically valid and experimentally determined.

9.3Nonconforming Work: A Natural Medicine Testing Facility shall have a documented system by which it investigates Nonconformances within its quality management system. This system must include a standardized process for documenting Nonconformances which must include, but shall not be limited to, the following items:

9.3.1 A detailed description of what occurred to include, as appropriate, instrument ID, sample ID, batch ID, SOP number or title, Quality Control failure, client complaint, and date of occurrence;

9.3.2 An estimate of the severity of the consequences of the Nonconformance;

9.3.3 The impact of the Nonconformance;

9.3.4 Persons responsible for any part of the generation or review of the nonconforming work;

9.3.5 A thorough investigation to determine a root cause of the Nonconformance by a prescribed analysis process, to include the person(s) assigned to the root cause investigation and associated deadlines for completion;

9.3.6 A list of any analytical batches that were impacted and a list of Sample results recalled;

9.3.7 Whether or not work was stopped;

9.3.8 Corrective and/or Preventative Actions identified to include deadlines and the person(s) assigned to implement the action and actual dates of implementation;

9.3.9 The Nonconformance report must not be closed until all identified Corrective and Preventative Actions are implemented. The closed report shall be reviewed, signed, and dated by the Natural Medicine Testing Facility director or delegated quality assurance manager; and

9.3.10 An assigned deadline for future review to evaluate the effectiveness of Corrective and Preventative Actions.

9.4Laboratory Reanalysis. A Natural Medicine Testing Facility must establish a policy regarding the retesting of client Samples. For the purposes of this rule, retesting does not include reanalysis of samples performed because quality control requirements were not met as described in the applicable standard operating procedure.

9.4.1 Reanalysis policies must specify the laboratory testing must be performed on the same homogenized Sample submitted to the Natural Medicine Testing Facility and include criteria by which the original result is confirmed or invalidated. The Natural Medicine Testing Facility must contact the submitting client when reanalysis is performed. A Natural Medicine Testing Facility shall follow the Nonconforming work process outlined in Rule 9.3 for every reanalysis.

9.4.1.1 Prior to reporting a result that differs from the original data point, a Nonconformance for retests outlined in Rule 9.3 must be submitted to the Department and the Colorado Department of Revenue.

9.4.1.2 Failure to do a scientifically valid investigation, a root cause analysis, or monthly review of open Nonconformances where no root cause has been determined will be considered a violation of rule.

9.4.3 Multiple amended test results for the same cause or same test type may indicate that test results are not accurate, precise, or scientifically valid. In the event of three or more invalidated results within a six month period, the Natural Medicine Testing Facility shall evaluate all relevant aspects of the pre-analytic, analytic, and post-analytic systems to determine the source of the error and implement Corrective Actions.

9.4.4 Failure to complete the Nonconforming work process outlined in Rule 9.3 in a manner that is sufficient to identify and prevent the recurrence of analytical errors is cause for suspension or revocation of certification for the affected test category.

5 CCR 1005-7-9

47 CR 24, December 25, 2024, effective 1/14/2025