LARA-MMFLA Bulletin Release Guidelines for Safety Compliance Facilities 7-6-18

[KLAW Blog]

A new advisory bulletin has been issued by the Bureau of Medical Marihuana.

Proficiency Testing Guidelines for Safety Compliance Facilities.

Released July 5, 2018

The Medical Marihuana Facilities Licensing Act (MMFLA) and the May 30, 2018 Emergency Rules require the Dept of Licensing and Regulatory Affairs to establish a proficiency testing program and designate safety compliance facility participation.

A safety compliance facility shall analyze proficiency test (PT) samples using the same procedures with the same number of replicate analyses, standards, testing analysts and equipment as used for marihuana product testing. The following proficiency testing must be performed by Safety Compliance Facilities (SCFs) annually:

• SCFs will need to complete one set of PT samples for all tests on their scope of accreditation.
• Proficiency test results must be conveyed as numerical accuracy percentages, not simply as PASS/FAIL results. Actual PASS/FAIL results must be calculated based on accuracy thresholds generated by reproducibility studies specific to each assay.
• Safety Compliance Facilities may use any ISO 17043 accredited laboratory for their testing needs. There are several ISO 17043 accredited laboratories where samples can be purchased, including The Emerald Test, NSI Lab Solutions, Sigma-Aldrich and Absolute Standards Inc.
• For parameters where there are currently no commercially available PT samples, SCFs should send samples (as blind samples) to another licensed SCF who performs testing by the same or similar methodology. The results should then be compared. A passing grade for the PT requires a score of at least 80%.
• Copies of all proficiency testing (both acceptable and unacceptable) results need to be sent to the department for review via email: LARA-BMMR-Enforcement@michigan.gov. Please indicate in the subject line “Proficiency Testing Results for Review-SCF Name.”

 

It is also available at the following link…PDF Document

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