RFI DOR17006 Lab Profeciency.pdf

Request for Information

# DOR17006/Lab Proficiency

April 6, 2017

RFI DOR17006/ Lab Proficiency

Glossary of Terms

This Request for Information (RFI) contains references to many terms and acronyms that are unique and specific to State and Department systems. The following glossary is presented to offer a quick reference for the reader who may not be familiar with all of these terms.

Certified Vendor An approved Vendor whose key personnel and support personnel have been found suitable by MED, and who has entered into a contract with the Department to provide proficiency testing.

CDPHE Colorado Department of Public Health and Environment

Concentrate A specific subset of retail Marijuana that was produced by extracting cannabinoids.

Cultivation A licensed business where Marijuana plants are grown, harvested and packaged.

Department Colorado Department of Revenue

Infused Product A product that is comprised of Marijuana and other ingredients and is intended for use or consumption, such as, but not limited to, edible product, ointments, and tinctures.

Infused Products Manufacturer A licensed business that may produce Infused Products or Concentrates but are not authorized to sell directly to consumers.

Licensee A person or business that has been approved for a state license by MED. This includes occupational badge holders, stores, Cultivations, Infused Products Manufacturers, Testing Facilities, and transporters.

MED Marijuana Enforcement Division, Colorado Department of Revenue

Marijuana All parts of the plant of the genus cannabis whether growing or not, the seeds thereof, the resin extracted from any part of the plant, and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or its resin, including Marijuana concentrate, that is cultivated, manufactured, distributed, or sold by a licensed Marijuana establishment.

Proficiency Testing Program A process designed to evaluate the ability of a MED Licensed Testing Facility to accurately conduct MED’s required testing on Marijuana.

PTP 3rd Party Proficiency Testing Provider, an independent company that will implement and provide a Proficiency Testing Program on behalf of the State.

RFI This Request For Information

State State of Colorado, including all state agencies

Testing Facilities MED licensed business permitted to conduct laboratory tests on

Marijuana according to Colorado Statutes and MED regulations.

Vendor Person or company who is responsive to the RFI

I. ADMINISTRATIVE INFORMATION

As provided in Colorado Revised Statutes 12-43.3-202 (2.5)(a)(I)(A) & 12-43.4-202 (3)(a)(IV)(A), the Colorado Department of Revenue, Marijuana Enforcement Division (MED), is responsible for establishing a Marijuana testing and certification program to ensure at a minimum that products sold for human consumption do not contain contaminants injurious to health. In addition, 12-43.3-405 (2) & 12-43.4-405 (2) C.R.S.

grant authority for MED to promulgate rules related to acceptable testing practices to include testing standards and quality control analysis. MED Rules M 703 & R 703 outlines the certification requirements that a licensed testing facility must meet in order to perform tests in a particular testing category. Specifically, MED Rules M 703 (B)(6) & R 703 (B)(6) require a licensed testing facility to successfully participate in a MED approved Proficiency Testing Program in order to obtain and maintain certification. Further, MED Rules M 707 & R 707 require a licensed Testing Facility to participate in a Proficiency Testing Program.

MED is seeking information regarding proficiency testing services for licensed Testing Facilities. MED is seeking qualified Vendors to perform the proficiency testing for the licensed Testing Facility community.

Information any interested party wishes to submit will be done so voluntarily and with the understanding that this RFI is for information gathering purposes. The Department shall be under no obligation to pay for any information and ideas submitted in response to this RFI or any of the costs incurred by any party as a result of this RFI. The Department may elect to use all or part of the information submitted as a response to this RFI to create a Certified Vendor List. This RFI is exempt from procurement code. No formal solicitation will be issued nor are remedies available.

The purpose of this RFI is to gather information that will be used to determine the viability of using multiple testing labs for lab proficiency testing; determine benefits that may be afforded by using multiple testing labs; and potentially create a Certified Vendor List, identifying the Vendor(s) who are qualified to perform proficiency testing services to meet the needs of MED. Based on the responses received, MED may ultimately determine NOT to structure the proficiency testing services along the lines of a Certified Vendor List.

This is a no cost contract to the State. Prices/costs provided are for informational purposes. At any time during the term of the contract, including any extensions, the Department may request disclosure of the Vendor’s current pricing structure. A Vendor’s pricing must be uniform statewide.

The information that follows is intended to provide background information and provide general expectations of performance.

MED is responsible for the regulation and enforcement of the commercial medical and retail Marijuana industry. Its mission is to administer and enforce medical and retail Marijuana laws and regulations in a fair and equitable manner through efficient and effective fiscal and operational management policies, operable enforcement strategies and collaborative partnerships with stakeholders that establish public trust and value in the agency. MED does that through background checks, licensing, field enforcement, and analysis of data.

Currently, MED rules require the categories of Marijuana including retail Marijuana, retail Marijuana Concentrates, and retail Marijuana products to be tested. The required testing includes testing to determine the potency of each category as well as contaminant testing to include both microbial and residual solvent testing. Additional testing may be required in the future to include metals, pesticides, or other chemicals and/or contaminants. Also, medical Marijuana is required to be tested in the test type of potency only.

Under federal law, Marijuana is a Schedule 1 Narcotic, and it is illegal, under Title 18 of US Code to manufacture, distribute or sell Marijuana. Nevertheless, the U.S. Department of Justice has issued guidance, as recently as 2013, which established federal law enforcement priorities to focus on the most critical threats to public safety, namely diversion of Marijuana out of state, the involvement of criminal enterprises in the regulated market, and the use of Marijuana by minors.

As of January 1, 2017 there were 14 licensed Testing Facilities that could potentially conduct tests and participate in a Proficiency Testing Program. In addition, there were approximately 1,400 Cultivations and 500 Infused Product Manufacturers that could potentially be required to send test samples for testing if both retail and medical testing were required. Medical testing can only be required once proficiency testing has been completed in the particular test type and corresponding category of Marijuana. Since flower bud potency is the only category and test type that licensees have successfully participated with regard to proficiency testing, that is the only current required test for the medical industry.

An important aspect of the regulated Marijuana industry in Colorado is the implementation of effective testing regulations. Those regulations require a program for Testing Facilities licensed by MED to successfully participate in a Proficiency Testing Program. A 3rd Party Proficiency Testing Provider (PTP) would be approved by Colorado Department of Public Health and Environment (CDPHE) and MED to evaluate MED’s licensed Testing Facilities. CDPHE and MED require Testing Facilities to participate in a Proficiency Testing Program three times per year, per test type, per Marijuana category. Successful participation in proficiency testing is required for Testing Facilities to earn or maintain certification for each category of testing. A licensed Testing Facility would be required to cover all costs associated with the Proficiency Testing Program and could choose to participate with any PTP on the certified list. The licensed Testing Facility must follow all standards, as determined by CDPHE and MED. The PTP will submit the results and analysis to CDPHE for their evaluation and CDPHE will recommend to MED continued or revoked certification.

A. Inquiries

Inquiries regarding this process, the submission of general or specific information, including the need for any information from MED staff, and any and all other questions shall be submitted in writing. The Purchasing Agent shall be the sole contact for any inquires. Vendors should not reach out to MED staff.

Email is the acceptable and preferred format for inquiries. The deadline for inquiries is Monday April 17, 2017, at 12:00pm MT.

Inquiries must be sent to:

Elizabeth Hewes, Purchasing Agent Colorado Department of Revenue Email: elizabeth.hewes@state.co.us

B. Submission of RFI Responses

Please send responses to:

Elizabeth Hewes, Purchasing Agent Colorado Department of Revenue 1375 Sherman, RM 336 Denver, CO 80203 Email: elizabeth.hewes@state.co.us

Responses to the RFI must be received on or before Tuesday April 25, 2017 at 1:00pm MT, and may be submitted via email. Responses submitted past the deadline may not be considered.

In addition to providing answers to the specific questions in Sections III, the information and ideas submitted may also address, in general terms, any features, conditions or provisions the Vendor feels should be considered that would generate additional value in terms of effectiveness and efficiency in regulating Colorado’s licensed commercial Marijuana industry.

C. Meetings/Presentations

Vendors responding to this RFI may be invited to present to Department personnel.

However, the Department does not guarantee that submission of information by a Vendor will result in a scheduled meeting.

Meetings with the Department may begin upon receipt of responses from Vendors.

Tentatively, presentations/ site visits will be conducted the week of May 15, 2017.

The exact dates and times will be coordinated and mutually agreed upon by the Department and the Vendor, with the Department making the final decision in the absence of mutual agreement. The Purchasing Agent shall be the sole contact for any meetings. Vendors should not reach out to MED staff.

D. Disclosure of Responses

The Department reserves the right for information submitted in response to this RFI to be reviewed by other entities within state government, and potentially with a consultant for purposes of compiling and analyzing possible options. In the event that a contract is awarded on the basis of the RFI process, materials will be made available for public disclosure after award of the contract. Otherwise, the materials submitted in response to this RFI will not be publicly disclosed until the RFI has been formally closed. At such time, all materials will be made available for public disclosure with the exception of those materials determined by the Department to be confidential and/or proprietary (as identified in Section I. E below).

mailto:elizabeth.hewes@state.co.us mailto:elizabeth.hewes@state.co.us

E. Confidential/Proprietary Information

Any restrictions on the use or inspection of material contained within the response shall be clearly stated in the response itself. Written requests for confidentiality shall be submitted by the Vendor, with the response, along with justification for considering the materials confidential/proprietary. The Vendor must state specifically what elements of the proposal are to be considered confidential/proprietary and/or considered to be intellectual property of the respondent.

Confidential/proprietary information must be readily identified, marked and packaged separately from the rest of the materials. Co-mingling of confidential/proprietary and/or intellectual property and other information is NOT acceptable. Neither a response, in its entirety, nor response price information will be considered confidential and proprietary.

The Purchasing Agent will make a written determination as to the apparent validity of any written request for confidentiality. In the event the Department does not concur with the Vendor's request for confidentiality, the written determination will be sent to the Vendor. Ref. Section 24-72-201 et. seq., C.R.S., as amended, Public (open) Records.

II. REQUIREMENTS

• The PTP must, at a minimum, be accredited as a proficiency testing provider meeting the requirements of ISO/IEC 17043:2010 General Requirements for Proficiency Testing.

• If PTP subcontracts with another proficiency testing provider for manufacturing of samples and/or analysis of the participant results, this subcontractor must, at a minimum, be accredited as a proficiency testing provider meeting the requirements of ISO/IEC 17043:2010 General Requirements for Proficiency Testing.

• The PTP must demonstrate an ability to create and distribute samples as well as evaluate proficiency testing results in accordance with the guidelines and protocols issued by CDPHE and MED. PTP may be asked to assist CDPHE and MED in the development of the final guidelines and protocols.

• The PTP must provide samples to Testing Facilities for each test type and category of Marijuana for the proficiency testing events that a Testing Facility participates in.

This includes but is not limited to potency and microbial contaminant testing for flower, concentrates, and edibles, in addition to residual solvent testing for concentrates.

• The PTP must have the ability to collect data from testing results to evaluate Testing Facility participation.

• The PTP must provide the Testing Facility results from the proficiency testing event to the participating laboratory, as well as to CDPHE and MED.

• The PTP will recover all costs through fees assessed to testing facilities. No fees will be assessed to the State.

• The PTP will be required to enter into a contract with the State. The contract to be executed is included as an attachment to this RFI (see attachment labeled Draft Contract). The Vendors signature on the Confirmation of Offer (see attachment labeled Confirmation of Offer) is confirmation that the Vendor understands and acknowledges that participation in the Proficiency Testing Program will require a contract between the State and the Vendor containing the terms and conditions in the attached contract. Vendor agrees to all terms and conditions of the contract and agrees to sign the contract as is, with no modifications. If the Vendor submits any contractual modifications with its proposal, the State may deem that as non-acceptance of the contract and may disqualify the Vendor from consideration. The State, at its sole discretion, may propose contract modifications. The State does not intend to include the Vendors entire proposal as an exhibit to the resulting contract. The State reserves the right to request any or all of the Vendors to resubmit specific portions of their proposal relative to the needs of the contract and performance of services. This process may require redaction and/or rewrite of proposals

III. SOLICITATION OF INFORMATION

PLEASE RESPOND, IN WRITING, TO EACH OF THE ITEMS BELOW:

1. Identify the point-of-contact for any questions or concerns relative to this response. Provide name, title, address, telephone number, and email addresses.

2. Provide description of your organization’s capabilities, with particular attention to the services identified in this RFI. Please include any innovative or unique approaches or practices that might differentiate your solution.

3. Provide detailed information if your organization plans or is considering partnering or otherwise affiliating with other Vendors, subcontractors or other organizations or individuals to provide support to meet requirements.

4. Provide proof of your accreditation status as a proficiency testing provider. If subcontracting out all or part of the services, provide proof of the subcontractor’s accreditation status as a proficiency testing provider.

5. Demonstrate years of experience in proficiency testing services requested in the

RFI.

6. Describe the categories of Marijuana proficiency testing offered. Include the target analytes (chemical components or species), whether the test is quantitative or qualitative, and the sample matrix type(s).

7. Describe the number of Marijuana proficiency testing events that your organization currently offers per year per testing category.

8. Describe the types of samples used, or that would be used, to conduct the program (Marijuana and/or non-Marijuana samples).

9. If using Marijuana samples, describe the process for obtaining those samples.

10. Describe the sample preparation process including the location of sample prep, storage, and distribution of samples to Testing Facilities.

11. Describe how the results of the tests would be provided to each of the stakeholders.

12. Provide an executive summary or copies of any key policies, programs, procedures and instructions that ensure quality of service.

13. Describe generally any internal and external controls and procedures which ensure the physical security of the Testing Facilities, and ensure the security of samples during transport.

14. Provide a detailed description of staff knowledge and experience for principals and support personnel sufficient to support the services outlined. Education and training should be addressed. Knowledge and experience should include proficiency in testing and any requirements unique to Colorado.

15. Describe any relationship of Vendor with Licensees. Additionally, describe and document any activity or work performed or anticipated to be performed, or proposed, by the Vendor, in the cannabis business space, whether in Colorado, nationally, or internationally.

16. The Department may disqualify a Vendor if the Department determines that an

Vendor or its owners, officers, directors, or partners cannot pass a criminal background check. Describe how your lab employees are screened. If awarded, employees may be submitted to a criminal background check at the Vendor’s expense.

17. Indicate your organization’s ability to meet with the Department and present information within the scope of this RFI. This may include site visits, oral presentations, and/or physical demonstrations as deemed necessary by the Department. The purpose of the visits, presentations, and demonstrations is to allow the Department the opportunity to gain a better understanding of the Vendor’s business and services. Note: Vendor is responsible for all costs associated with such a presentation.

18. Provide estimated pricing for lab proficiency testing. Please use the attached pricing sheet.

19. Identify and explore other issues or challenges relevant to this RFI that would be helpful to MED.

20. Confirm acceptance of State contract. If modifications are being proposed, please provide suggested modifications with your response.