Back in the Lab: CCD Issues NCAs to Two New Mexico Testing Labs
The (CCD) of New Mexico has taken significant regulatory action against two testing laboratories, Bluebonnet Labs LLC and CristoClear Labs, citing numerous violations that could severely impact their ability to operate. These cases highlight persistent struggles within the state's testing sector, underscoring the challenges faced by labs in meeting strict compliance standards.
Violations Against Bluebonnet Labs
During a November 2024 inspection, Bluebonnet Labs LLC was found to have committed 11 regulatory violations, including lapses in storage, documentation, training, and operational practices. These violations include:
Improper Storage of Samples
Failure to store samples securely and in conditions that prevent degradation or contamination.
Rule: 16.8.2.48 (E)(1) & (2) NMAC.
Improper Storage of Reagents and Solutions
Mixing old samples with reagents and standards, risking contamination.
Rule: 16.8.2.48 (I) NMAC.
Failure to Maintain Laboratory Premises
Poor cleanliness, lack of organization, and insufficient equipment for laboratory operations.
Rule: 16.8.2.48 (G) NMAC.
Falsifying Certificates of Analysis (COAs)
Listing a non-operational location as the testing site on compliance documents.
Rule: 16.8.2.48 (L)(i) NMAC.
Failure to Document Samples in the Track-and-Trace System
Inadequate documentation of samples within the state-mandated system.
Rule: 16.8.7.15 (L)(3) NMAC.
Failure to Maintain Equipment and Facility Standards
Lacking essential equipment and proper facilities for accurate sample testing.
Rule: 16.8.2.48 (G) NMAC.
Inadequate Record-Keeping
Missing records for test results, equipment maintenance, and training.
Rule: 16.8.7.15 (L)(4) & 16.8.2.47 (D) NMAC.
Unapproved Changes to Testing Methods
Making material changes to instruments and methods without CCD approval.
Rule: 16.8.2.44 (B)(1)(b)&(c) NMAC.
Lack of Required Training Policies
Failure to provide and document training programs for employee safety and equipment use.
Rule: 16.8.2.47 (B)(1), (2) & (3) NMAC.
Failure to Maintain Employee Training Records
Inability to produce documentation of completed training or refresher courses.
Rule: 16.8.2.47 (C) NMAC.
Noncompliance with Video Surveillance Requirements
Failure to maintain a compliant video surveillance system and provide footage for inspections.
Rule: 16.8.2.10 (D) & (E) NMAC.
CristoClear Labs: Struggling to Get Licensed
While Bluebonnet Labs faces potential license revocation, CristoClear Labs struggles to enter the market. The CCD has issued a Notice of Contemplated Action to deny CristoClear Labs' application for a testing laboratory license due to repeated failures to meet regulatory standards.
Core Violation: Inability to meet Initial Demonstration of Capability (IDC) standards, which ensure a lab's ability to produce accurate and reliable testing results.
Despite multiple submissions and resources provided by the CCD, CristoClear’s IDC failed to meet minimum standards for method calibration, accuracy, and detection limits.
The CCD has offered CristoClear Labs a chance to request a hearing to address these deficiencies. However, their repeated failure to meet compliance benchmarks casts doubt on their ability to secure licensure.
A Broader Concern: New Mexico’s Testing Infrastructure
With only six licensed testing facilities statewide, the challenges faced by Bluebonnet Labs and CristoClear Labs expose deeper issues within New Mexico’s testing framework. As of December 2024, the state reported 590,781 plants in production, underscoring the critical need for robust testing infrastructure to handle increasing demand.
Key concerns include:
Strict Compliance Standards: High regulatory demands pose challenges for under-resourced facilities.
Operational Complexities: Labs require specialized tools, highly trained personnel, and adherence to rigorous protocols.
Market Strain: Fewer labs could lead to delays, higher costs, and bottlenecks across the supply chain.
The CCD’s strict enforcement highlights the importance of maintaining high standards, but the strain on the system points to a need for better support, training, and infrastructure investment. Without these changes, the state risks further constricting its already limited testing capacity, potentially impacting the growth and reliability of the broader market.
