70-66500-26-78396_Sole_Source_Determination - Charm Sciences, Inc.pdf.PDF

Docusign Envelope ID: 64B8900F-4826-874D-823C-013A6C22BAD4

2026 Sole Source Form

STATE OF NEW MEXICO

SOLE SOURCE REQUEST AND DETERMINATION FORM

A sole source determination is not effective until the sole source request for determination has been posted for thirty (30) calendar days without Protest and subsequently approved in writing by the State Purchasing Agent. The foregoing requirement is regardless of whether the sole source request for determination has been signed by the Agency.

I. Name of Agency: Department of Health

Agency Chief Procurement Officer: Vincent Lujan Telephone Number: 505-623-1168

Agency Contact for this request: John Mondragon Email Address John.mondragon@doh.nm.gov/505-383-9078

II. Name of prospective Contractor: Charm Sciences Inc.

SHARE Vendor Number (must be active): 0000005880 Address of prospective Contractor:

659 Andover Street Lawrence, MA 01843-1032 Phone: 1-978-687-9200; Fax: 1-978-687-3216 Contact Name, Telephone Number and Email Address:

Dawn Stead, 310-744-5495, dawns@charm.com

Amount of prospective contract before tax: $59,154.58 Year 1 TBD - 06/30/27 $14,139.52 Year 2 07/01/27 - 06/30/28 $14,563.83 Year 3 07/01/28 - 06/30/29 $15,000.64 Year 4 07/01/29 - 06/30/30 $15,450.59

Estimated tax amount (tax is subject to change): Taxes included in total

III. Term of prospective contract: Four (4) Years upon signature Note: Please refer to §13-1-150 for contract term limits.

If this is an amendment request to an existing contract, include current sole source posting number issued by SPD:

The Environmental Microbiology Department processes dairy samples submitted to the Biological Sciences Bureau on a weekly basis. All methods and instrumentation must be approved by the FDA or the laboratory risks the loss of accreditation. Charm consumables and instruments are not only approved for use by the FDA but have proven to provide accurate and reliable data which assists the New Mexico Department of Agricultures (NMDA) determination of safe dairy sales to New Mexicans. It is critical to continue testing New Mexico dairies for antibiotic contamination to avoid harming consumers who may be allergic to antibiotics

IV. If this is a Sole Source for new or existing IT software licensing subscription(s), Agency is required to upload the Contractor’s draft Service Level Agreement (SLA) with the Sole Source online submission. NA

V. Agency is required to provide the detailed scope of work (or amendment) for this sole source. Scope of work must match the scope included in the services determination and Horizons declination.

Charm Sciences instruments function strictly with Charm Sciences consumables. To meet the required parameters of all dairy antibiotic testing, requires the use of Charm instruments and their associated consumables. All antibiotic testing and procedures have been validated by lab personnel based on approved FDA methods. To continue providing the New Mexico dairy industry with efficient analysis and data regarding submitted milk samples, the Environmental Microbiology Department requires the specified consumables for the instruments to function. Without Charm consumables, SLD will be unable to meet all testing requirements for NMDA. Without the appropriate materials, testing will come to a standstill and will unnecessarily jeopardize the health of New Mexicans with sensitivity to antibiotics who consume dairy products. Furthermore, the New Mexico dairy industry may be subject to financial strain since the ability to transport and sell dairy products is tied to the overall quality and safety of the milk samples tested by SLD.

VI. Provide a detailed explanation of the criteria developed and specified by the agency as necessary to perform and/or fulfill the contract and upon which the state agency reviewed available sources. (Do not use “technical jargon;” use plain English. Do not tailor the criteria simply to exclude other contractors if it is not rationally related to the purpose of the contract.

Consumables provided by parties other than Charm Sciences are not compatible with Charm instrumentation. Results may be subject to errors or inaccurate reading. Charm Sciences is the sole source for reagents and consumables for Charm Sciences instruments.

VII. Provide a detailed, sufficient explanation of the reasons, qualifications, proprietary rights or unique capabilities of the prospective contractor that makes their company the only source capable of providing the required professional service, general service, construction or item(s) of tangible personal property. (Please do not state the source is the “best” source or the “least costly” source. Those factors do not justify a “sole source.”)

It has been determined that Charm Sciences is the sole manufacturer and vendor for the Charm Sciences dairy analysis instruments approved by the FDA. The vendor is intimately familiar with their instruments, is the sole source of factory produced consumables, and has in the past provided proven high-quality service and maintenance for SLD instrumentation. Furthermore, FDA has approved few products for conducting the various tests that SLD utilizes for dairy sample analysis. It is unknown whether other companies and manufacturers will begin producing compatible consumables and reagents for Charm instruments in the future. Charm Sciences is the exclusive manufacturer of consumables, approved by the Food and Drug Administration (FDA), for dairy testing. Charm instrumentation requires consumables solely produced by Charm Sciences Inc. There are no alternative manufacturers or vendors that can provide PAS-ISO-100NSK KIT

ALKPHOS/ DAIRY/ ISO PROCEDURE/ NO STND/ 100T, LF-SLBL-EZ-100K KIT LF/

SL/ BETALACTAM/ MILK/ EZ/ 100T, LF-TET-SL-100K KIT LF/ TETRACYCLINE/

MILK/ 300PPB/ 100T, LF-SL3-100K KIT LF/ CHARM 3 SL3/ BETALACTAM/ MILK/

100T, and SULFA-100K KIT SULFONAMIDE/ MILK/ 100KIT.

VIII. Provide a detailed, sufficient explanation of how the professional service, general service, construction or item(s) of tangible personal property is/are unique and how this uniqueness is substantially related to the intended purpose of the contract.

The choice of test system or reagents that will be used to test for milk requires extensive research regarding the products being considered. This knowledge is based on keeping up with the latest information obtained by laboratory managers from other states when attending conferences, reviewing notices from the Food and Drug Administration (FDA) and contacting vendors to determine their requirements and pricing. The cost of the reagents and any instruments used are also considered to ensure that the laboratory can stay within budget.

Once this decision is made, the laboratory must then validate tests to ensure confidence and reliability in the test results provided by the accredited/certified laboratory (SLD), the laboratory must first validate its specific test methods to prove they are reliable and meet certain standards. The laboratory must then follow the validated procedures without any modifications whenever the test is run. Any deviation from the methods and specific materials used in the validation procedure requires a re-validation of the testing method before it can be used by SLD. The SLD is prohibited from performing tests using that method until the new validation is completed with the substituted testing materials and the substituted materials are proven to perform similarly or better than those used in the current validated method.

Additional validations are costly and interfere with testing for months, adversely affecting antibiotic contamination control and prev3ention as well as the health and safety of the public. Therefore, SLD must utilize those specific supplies and materials that were used in procedures approved by the FDA.

IX. Provide a narrative description of the agency’s due diligence in determining the basis for the procurement, including procedures used by the agency to conduct a review of available sources such as researching trade publications, industry newsletters and the internet;; contacting similar service providers; and reviewing the State Purchasing Divisions’ Statewide Price Agreements. Include a list of businesses contacted (do not state that no other businesses were contacted), date of contact, method of contact (telephone, mail, e-mail, other), and documentation demonstrating an explanation of why those businesses could not or would not, under any circumstances, perform the contract; or an explanation of why the agency has determined that no businesses other than the prospective contractor can perform the contract.

Fisher Healthcare, one of the largest laboratory equipment and supply distributors in the US, was contacted. Sales representative, Cecille Sanchez, informed SLD that they were not a vendor of any Charm Sciences equipment or materials via email on April 6th, 2026.

Charm Sciences Inc., the manufacturer of Charm Sciences dairy instruments, was asked if they work with any biomedical distributors for sales of their products and instruments. The VP of Technical Services, Stephen Holmes, sent a sole source certification confirming Charm Sciences to be the sole producer, vendor, and distributor of Charm Sciences products on January 27th, 2026.

Agency certifies this sole source submission complies with NMSA 1978, Sections 13-1-28 through 13-1-199, the New Mexico Administrative Code (NMAC) and Governmental Conduct Act, NMSA 1978, Sections 10-16-1 through 10-16-18.

Certified by: Date:

Agency Chief Procurement Officer

Certifying Legal Sufficiency by: Date:

Agency Legal/General Counsel

Agency Approval by: Date:

Cabinet Secretary/Agency or Entity Head or Designee

APPROVED: Date:

State Purchasing Agent

If this sole source is being submitted by a governmental agency or governmental entity not under the authority of the State Purchasing Agent, the State Purchasing Agent’s signature is not required. The signature line may be removed from this form or marked as N/A. Hard Copy Documentation for Courtesy Postings do not need to be submitted to SPD for approval.