Medical Cannabis Project PCC Certification Phase: Close Out February 27, 2019 Terry Reusser, DOH CIO Kenny Vigil, MCP Director Twila Kunde, Deputy Director, SLD Helene Minot, Project Manager 1190 S. St. Francis Drive • Santa Fe, NM 87505 • Phone: 505-827-2613 • Fax: 505-827-2530 • nmhealth.org
Outline Overview Certification History Budget & Expenditures Background Project Goals Certification History Budget & Expenditures Lessons Learned Close Out Summary
Overview Initial Goals: Technical Objectives: Establish a QA lab at the DOH Scientific Laboratory Division (SLD) to test Cannabis products Add functionality to Bio Track application to support the growing business needs including web based patient on-line application functionality. Technical Objectives: Upgrade LabWare to perform testing of cannabis products Upgrade 5 instruments Add 16 tests Capture additional LNPP’s business locations Add “<“ symbol for lab result tracking Batch size limit Unit calculations within the Seed to Sale lifecycle
Certification History Funding Source: 11415 Other State Funds/Other Revenue (Operating budget) Date Phase Amount 11/27/2017 Initiation $234,988 2/28/2018 Planning $ 15,000 5/23/2018 Implementation $ 225,000 Total $474,988
Budget & Expenditures Project Deliverable Budget Costs Project Manager Contract $196,522 $173,590 IV&V $ 38,466 $38,466 Bio Track Enhancements $ 10,000 $0 LabWare Deliverable $230,000 $224,000 Total $474,988 $436,056 Under Budget $38,932
Lessons Learned Laboratory methods for Cannabis testing were not in place prior to the Labware implementation Ensure methods are validated prior to upgrading the Laboratory Information Management System (LIMS). Testing and validation must be completed before system changes are implemented. SLD staff unable to commit their time to only this project due to other mandated testing. During system testing this added stress, as they had to juggle regular work Dedicate technical (SLD lab staff) to only analytical method validation to ensure target production dates are met. Due to being a cross division project, the PM did not have access to lab staff. Access to staff in all departments to ensure tasks are tracking to meet project schedule.
Close Out Summary Project Accomplishments: LabWare was upgraded and configured Interfaces for 4 instruments were configured ELISA Abraxis – not interfaced; but can test Cannabis Validated 5 tests for operations E-coli (flower and edibles) Salmonella (flower and edibles) Loss on drying (flower) Total Aerobic Count (edibles) Staph aureus - Non-USP and USP (edibles) Seven (7) additional tests are in process of validation and method development for flower, concentrates, oils and edible product types. Bio Track added 6 extra address locations to track LNPP business locations at no charge. Notification of SLD’s operational readiness for Cannabis testing sent to Licensed Non Profit Producers (LNPP’s).
Close Out Summary Project Budget Project Completion $38,932 under budget Project Completion 2 month delay