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

Description

{"description":"DEPARTMENT OF VETERANS AFFAIRS\nVA MEDICAL CENTER, SALT LAKE CITY, UT\n\nSTATEMENT OF WORK \nKashi MMDx- Heart Transplant Rejection Blood Test Reporting, or Equal\n\nIntroduction\nDepartment 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.\nScope of Work\nThe 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. \nDescription\nThe 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.\nThe 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.\nThe contractor shall perform testing entirely upon their premises.\nTests will be performed and reported within established vendor turnaround times.\nThe 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.\nThe contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements.\nThe contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge.\nNotwithstanding, 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.\nThe 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. \nSchedule of Services\nDescription/Part Number\nQty\nKASHI report from MMDx testing, or equal\n30\n\nGeneral Requirements\nThe 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. \n\nThe price list, at a minimum, shall include the following data elements:\nCPT code\nProduct Name/Description \nPrice\nTest description, including reference ranges and units of measurement\nMaximum turn-around-time (TAT) shall not exceed 48 hours from specimen receipt.  \n\nTest Result Reporting\n\nThe 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. \n \nAll 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:\n\ni. Invoice Number\nii. Date of Service\niii. Test Description and CPT Code\niv. Unit cost\nv. Total cost\n\nMandatory Requirements\nLicensing 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.\nThe 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). \nThe Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA).\nThe 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.\nThe 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.\nContractor 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.\nIn 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: \nNAICS Code: 621511\nCompany Name:\nAddress:\nUEI (Unique Entity ID) Number:\nContact Name:\nPhone No.:\nEmail:\nBusiness Size Information - Select all that applies:\nSmall Business\nEmerging Small Business\nSmall Disadvantaged Business\nCertified under Section 8(a) of the Small Business Act\nHUBZone\nWoman Owned\nCertified Service-Disabled Veteran Owned Small\nVeteran Owned Small Business\nLarge Business\nFSS/GSA Contract Holder:\nYes No \nFSS/GSA Contract Number:\n\nEffective Date/ Expiration Date:\n\nProposed solution is listed and available on the above FSS/GSA Contract:\nYes No \nAvailable pricing structure of proposed solution (select all that are applicable below):\nPricing Model\nPlease Indicate Availability Below: (Yes / No / NA)\nAll on FSS\nOpen Market only\nMix of FSS & Open Market\n(CPRR) Cost Per Reportable Result \n\n\n\nCost Per Test(CPT)\n\n\n\nReagent Rental Agreement\n\n\n\nEquipment Rental with Reagent Purchase\n\n\n\nFixed Monthly Charge\n\n\n\nOther: (Please explain)\n\n\n\nFederal Acquisition Regulation (FAR) Market Rearch Questions:\nBuy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a:\nDomestic end product? _____________ (%)\nForeign end product? _______________ (%)\nQuestions for Small Businesses ONLY:\nLimitations 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: __________\nIf subcontracting, what added value do you offer (FAR 52.215-23): _______________________________\nNonmanufacturer Rule (FAR 52.219-33):\nDoes your company manufacturer these proposed items? [ ] yes [ ] no\nDoes your company exceed 500 employees? [ ] yes [ ] no If yes, list # of employees: _________\nDoes your company primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied? [ ] yes [ ] no\nDoes your company take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? [ ] yes [ ] no\nDoes 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. [ ] yes [ ] no If yes, what is the manufacturer s name? ________________ \n\n\nThe 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. \n\n"} Solicitation Number: 36C25926Q0048 Type: Sources Sought Base Type: Sources Sought NAICS: 621511 Classification Code: Q502 Response Deadline: 2025-11-07T15:00:00-07:00 Office Address: Greenwood Village, CO Place of Performance: Salt Lake City, UT, 84148 POC: Lindsey Zwaagstra, Lindsey.Zwaagstra@va.gov, 303-712-5733 {"description":"DEPARTMENT OF VETERANS AFFAIRS\nVA MEDICAL CENTER, SALT LAKE CITY, UT\n\nSTATEMENT OF WORK \nKashi MMDx- Heart Transplant Rejection Blood Test Reporting, or Equal\n\nIntroduction\nDepartment 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.\nScope of Work\nThe 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. \nDescription\nThe 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.\nThe 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.\nThe contractor shall perform testing entirely upon their premises.\nTests will be performed and reported within established vendor turnaround times.\nThe 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.\nThe contractor shall provide individual patient-chartable test result reports meeting Clinical Laboratory Improvement Amendments (CLIA) requirements.\nThe contractor shall provide all appropriate requisition forms and unique supplies needed for specialized collection of samples, at no additional charge.\nNotwithstanding, 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.\nThe 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. \nSchedule of Services\nDescription/Part Number\nQty\nKASHI report from MMDx testing, or equal\n30\n\nGeneral Requirements\nThe 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. \n\nThe price list, at a minimum, shall include the following data elements:\nCPT code\nProduct Name/Description \nPrice\nTest description, including reference ranges and units of measurement\nMaximum turn-around-time (TAT) shall not exceed 48 hours from specimen receipt.  \n\nTest Result Reporting\n\nThe 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. \n \nAll 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:\n\ni. Invoice Number\nii. Date of Service\niii. Test Description and CPT Code\niv. Unit cost\nv. Total cost\n\nMandatory Requirements\nLicensing 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.\nThe 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). \nThe Contractor policies and procedures shall comply with the Health Insurance Portability and Accountability Act (HIPAA).\nThe 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.\nThe 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.\nContractor 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.\nIn 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: \nNAICS Code: 621511\nCompany Name:\nAddress:\nUEI (Unique Entity ID) Number:\nContact Name:\nPhone No.:\nEmail:\nBusiness Size Information - Select all that applies:\nSmall Business\nEmerging Small Business\nSmall Disadvantaged Business\nCertified under Section 8(a) of the Small Business Act\nHUBZone\nWoman Owned\nCertified Service-Disabled Veteran Owned Small\nVeteran Owned Small Business\nLarge Business\nFSS/GSA Contract Holder:\nYes No \nFSS/GSA Contract Number:\n\nEffective Date/ Expiration Date:\n\nProposed solution is listed and available on the above FSS/GSA Contract:\nYes No \nAvailable pricing structure of proposed solution (select all that are applicable below):\nPricing Model\nPlease Indicate Availability Below: (Yes / No / NA)\nAll on FSS\nOpen Market only\nMix of FSS & Open Market\n(CPRR) Cost Per Reportable Result \n\n\n\nCost Per Test(CPT)\n\n\n\nReagent Rental Agreement\n\n\n\nEquipment Rental with Reagent Purchase\n\n\n\nFixed Monthly Charge\n\n\n\nOther: (Please explain)\n\n\n\nFederal Acquisition Regulation (FAR) Market Rearch Questions:\nBuy American Act (FAR 52.225) What percentage of the proposed product (including leases) is a:\nDomestic end product? _____________ (%)\nForeign end product? _______________ (%)\nQuestions for Small Businesses ONLY:\nLimitations 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: __________\nIf subcontracting, what added value do you offer (FAR 52.215-23): _______________________________\nNonmanufacturer Rule (FAR 52.219-33):\nDoes your company manufacturer these proposed items? [ ] yes [ ] no\nDoes your company exceed 500 employees? [ ] yes [ ] no If yes, list # of employees: _________\nDoes your company primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied? [ ] yes [ ] no\nDoes your company take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice? [ ] yes [ ] no\nDoes 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. [ ] yes [ ] no If yes, what is the manufacturer s name? ________________ \n\n\nThe 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. \n\n"}