Q502--5 Year Firm-Fixed Price Blanket Purchase Agreement Heart Biopsy Transplant Testing- KASHI MMDx or Equal

DEPARTMENT OF VETERANS AFFAIRS

VA MEDICAL CENTER, SALT LAKE CITY, UT

STATEMENT OF WORK

Kashi MMDx- Heart Transplant Rejection Blood Test Reporting, or Equal

Introduction

Department of Veterans Affairs, Veterans Health Administration, Salt Lake City VA Medical Center (VAMCSLC), 500 Foothill Drive, Salt Lake City, Utah 84148 has a requirement for heart transplant rejection testing. The contract will be awarded as a firm fixed price blanket purchase agreement with a five-year ordering period.

Scope of Work

The Contractor will provide post-transplant Molecular Microscope Diagnostic System (MMDx) Expression test offered by the Kashi reference laboratory, or equal. The Kashi MMDx test, or equal, is utilized to determine if a heart post-transplant patient is rejecting their transplanted organ.

Description

The contractor shall be responsible for performing laboratory testing, analysis, and result interpretation on behalf of the VAMSLC facility in accordance with the terms, conditions, and provisions outlined thereof. These services shall include the performance of molecular analytical testing as defined by the contractors reference test manual, the reporting of molecular analytical test results, and consultative services as required to assimilate the full scope for patient care.

The services performance shall include specialized Kashi molecular analytical testing with varying levels of support services depending on the unique characteristics presented by each individual ordering activity.

The contractor shall perform testing entirely upon their premises.

Tests will be performed and reported within established vendor turnaround times.

The contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations as they pertain to a licensed clinical laboratory.

The contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements.

The contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge.

Notwithstanding, anything to the contrary in this Agreement or otherwise,The contractor shall not release patient records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All patient records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient's records. This provision shall survive termination of this Agreement.

The required highly specific molecular testing reference laboratory services include but are not limited to the identified required test menu testing, specimen preparation and storage of clinical laboratory specimens, performance of analytical testing; reporting of analytical test results; and consultative services.

Schedule of Services

Description/Part Number

Qty

KASHI report from MMDx testing, or equal

30

General Requirements

The contractors standard price list of all testing services available along with the price to be billed to the VHA for each testing service shall reflect that which is listed in their GSA price list.

The price list, at a minimum, shall include the following data elements:

CPT code

Product Name/Description

Price

Test description, including reference ranges and units of measurement

Maximum turn-around-time (TAT) shall not exceed 48 hours from specimen receipt. Â

Test Result Reporting

The Contractor shall provide encrypted and/or secured electronic transmission (i.e., fax and/or on-line web access) of all completed and/or partial test results to the ordering activity within published turnaround time (TAT), except where specified.

All payments shall be made in arrears (30 days) upon receipt of a proper invoice. Invoices must contain at a minimum the following information. The contractor shall provide this information on one original invoice:

i. Invoice Number

ii. Date of Service

iii. Test Description and CPT Code

iv. Unit cost

v. Total cost

Mandatory Requirements

Licensing and Accreditation: Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined. The contractor shall have all the licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988.

The contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America prior to contract award. In addition, the contractor shall be responsible for providing a written guarantee or evidence that all subcontractors have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award. Any proposed subcontractor changes during the contract performance period must have prior approval by the Contracting Officer (CO).

The Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA).

The contractor will provide and maintain quality assurance programs which meet federal regulations for laboratory operations. The contractor will be certified by the College of American Pathologist under the CLIA.

The contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the contractor or any employees, within 24 hours of notification of an investigation or suspension.

Contractor Personnel: The contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, CLIA certification, or clinical pathology certification. The contractor shall provide a copy of renewed licenses/certificates to the Contracting Officer before expiration.

In response to this announcement, please provide the information below. If this information is not provided, then it will be assumed the entire requirement cannot be met:

NAICS Code: 621511

Company Name:

Address:

UEI (Unique Entity ID) Number:

Contact Name:

Phone No.:

Email:

Business Size Information - Select all that applies:

Small Business

Emerging Small Business

Small Disadvantaged Business

Certified under Section 8(a) of the Small Business Act

HUBZone

Woman Owned

Certified Service-Disabled Veteran Owned Small

Veteran Owned Small Business

Large Business

FSS/GSA Contract Holder:

Yes No

FSS/GSA Contract Number:

Effective Date/ Expiration Date:

Proposed solution is listed and available on the above FSS/GSA Contract:

Yes No

Available pricing structure of proposed solution (select all that are applicable below):

Pricing Model

Please Indicate Availability Below: (Yes / No / NA)

All on FSS

Open Market only

Mix of FSS & Open Market

(CPRR) Cost Per Reportable Result

Cost Per Test(CPT)

Reagent Rental Agreement

Equipment Rental with Reagent Purchase

Fixed Monthly Charge

Other: (Please explain)

Federal Acquisition Regulation (FAR) Market Rearch Questions:

Buy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a:

Domestic end product? _____________ (%)

Foreign end product? _______________ (%)

Questions for Small Businesses ONLY:

Limitations on Subcontracting (FAR 52.219-14) What percentage of the work would be subcontracted to another company? ________ If > 0, what is company s business size: __________

If subcontracting, what added value do you offer (FAR 52.215-23): _______________________________

Nonmanufacturer Rule (FAR 52.219-33):

Does your company manufacturer these proposed items? [Â ] yes [Â ] no

Does your company exceed 500 employees? [Â ] yes [Â ] no If yes, list # of employees: _________

Does your company primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied? [Â ] yes [Â ] no

Does your company take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? [Â ] yes [Â ] no

Does your company supply the end item of a small business manufacturer, processor or producer made in the United States, or obtains a waiver of such requirement pursuant to paragraph (b)(5) CFR 121.406. [Â ] yes [Â ] no If yes, what is the manufacturer s name? ________________

The information submitted shall contain the company s business size status. This is a request for information and sources only, which may or may not lead to a future solicitation. This is not a request for quote (RFQ). No questions will be answered. The VA will not pay for any information received resulting from this sources sought notice. Requests for copies of a solicitation shall not be honored or acknowledged. Information should be forwarded to the Contracting Officer. If your organization can provide all services of this potential requirement and is interested in this opportunity, please respond to Lindsey Zwaagstra, Lindsey.Zwaagstra@va.gov, Contracting Officer, Department of Veterans Affairs, NCO 19, 6162 S. Willow Drive, Suite 300, Greenwood Village, Colorado 80111 and NCO19lab@va.gov  with a statement describing your capabilities and completed table above. The capability statement shall include a point of contact, complete mailing address, telephone number, email address and state the company s business size status. The deadline for this information to be received is 15:00 PM Mountain Time, 11/07/2025.