36C25026Q0549.docx

Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 10 Lobby M, Suite 2200 24 Frank Lloyd Wright Drive Ann Arbor, MI 48105

POINT OF CONTACT*

Contract Specialist Jessica Bryant Jessica.Bryant5@va.gov 734-845-5295

PLACE OF PERFORMANCE

Richard L. Roudebush VA Medical Center

ATTN: Pathology and Laboratory

1481 W. 10th Street

Indianapolis IN

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Sources Sought Notice

THIS IS NOT A SOLICITATION, THIS IS A SOURCES SOUGHT NOTICE ONLY and is issued in accordance with Federal Acquisition Regulation (FAR) 10 Market Research, to conduct market research. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. This Sources Sought Notice is issued solely for information and planning purposes and does not constitute a solicitation or guarantee to issue a solicitation in the future. This Sources Sought Notice does not commit the Government to contract for any supply or service. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Not responding to this Sources Sought Notice does not preclude participation in any future solicitation, if issued. This announcement and its contents is based on the best information available at this time and is subject to future modification.

Purpose and Objectives The Richard L. Roudebush VA Medical Center located at 1481 W. 10th Street, Indianapolis, IN 46202 requires specialized fungal disease testing services and eight (8) hour STAT testing in accordance with the Performance Work Statement (PWS) and test list. The Government intends to award a base plus four (4), one year, option years.

This Sources Sought Notice is being issued by the Veterans Health Administration (VHA), Network Contracting Office (NCO) 10 located in Ann Arbor, MI as part of market research for planning purposes. A draft copy of the PWS and required test list with estimated quantities are attached and is the only information available at this time.

The applicable NAICS Code is 621511 – Medical Laboratories Size Standard - $41.5 Million Product Service Code is Q301 – Medical – Reference Laboratory Testing

Responses:

Please submit your response in accordance with the following instructions:

a) Responses are due by 5/29/2026 at 10:00 AM EDT.

b) Responses shall be submitted via email to Jessica.Bryant5@va.gov

a. Subject line of the email shall include this Sources Sought Notice Number – Fungal Diagnostic Services – Firm Name

b. Complete sections C-G

c. Submit this document with any relevant attachments

c) Contractor Point of Contact to include:

a. Name:

b. Title:

c. Phone:

d. Email:

d) Company Information to include:

a. Name:

b. Address:

c. DUNs Number:

d. Tax ID Number:

e. Business Size:

e) Business Size/Type: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), 8(a), Hub Zone Small Business, Women Owned Small Business (WOSB), Small Disadvantaged Business (SDB), Small Business, or Large Business.

a. All prospective Contractors are reminded that in accordance with FAR 4.11 they shall be registered in the System for Award Management (SAM) database located at http://www.sam.gov and shall complete annual Representations and Certifications in SAM prior to any offer.

b. FOR SDVOSB/VOSB ONLY: Please note that if responding as SDVOSB or VOSB, your company must be registered in the SBA Small Business Search (SBS) database, which is available at: https://www.sba.gov/partners/contracting-officials/small-business-procurement.

c. Please include a copy of your SDVOSB/ VOSB Certification with your response.

f) Contractors Federal Supply Schedule Contract that carries the desired services.

a. If you do not have a Federal Supply Schedule contract, you shall state “open market”:

b. Provide the Schedule:

c. Provide your GSA/FSS/SAC Contract Number:

d. Provide the SIN(s) for reference laboratory testing:

e. If any of the items are not on your GSA/FSS contract you will mark which items are open market.

g) Contractor shall respond to the following questions as part of the requirements in the PWS:

Y N (check yes or no)

a. ☐☐ Are you able to comply with all the requirements listed in the PWS section C(a)?

b. ☐☐ Is your laboratory fully licensed/accredited and actively engaged in providing the specific services and laboratory testing outlined in the PWS section C(b)?

c. ☐☐ Is your laboratory licensed/ accredited by the College of American Pathologists (CAP), The Joint Commission (JTC), or any other licensing and/or accreditation as required by law in order to perform the required testing listed in the PWS?

d. ☐☐ Is your laboratory certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act of 1988?

e. ☐☐ Is your Laboratory Director an American Board of Pathology, certified Pathologist or American Board of Bioanalysis, certified Bio-analyst?

f. ☐☐ Do you have at least three years of experience providing laboratory services and at least one year experience in transporting biomedical materials?

g. ☐☐ Do you have all the CLIA certifications for the analyte specialties and sub-specialties listed in the PWS section C(b)(ii)(3)(a)?

h. ☐☐ Are you able to comply with the quality review requirements in the PWS section C(h)?

i. ☐☐ Are you able to provide on-site processing staff in accordance with the PWS section C(j)?

j. ☐☐ Are you able to provide the equipment, data management system, security, and connectivity requirements in accordance with the PWS section C(k)?

k. ☐☐ If awarded a future contract, do you plan to utilize a Sub-Contractor? If so, please provide the following information.

a. Company Name:

b. Address:

c. POC Email:

d. DUNs Number:

e. Business Size:

f. Describe work to be completed by the Sub-Contractor:

g. Describe work to be completed by Contractor:

l. ☐☐ Does the Sub-Contractor have all the appropriate licensure and accreditation mentioned above?

h) Contractor shall provide CLIA certificate of accreditation listing analyte specialties and sub-specialties listed in the PWS section C(b)(ii)(3)(a) for itself and for its Sub-Contractor.

i) Contractor shall provide a letter from the Sub-Contractor that demonstrates that the Sub-Contractor agrees to perform all tests not performed by the Contractor, to include those tests that the Contractor is not certified to provide itself.

j) Contractor shall include any relevant comments for any attachments, if applicable.

k) Include a copy of an official quote for the following services as required in PWS.

8/1/2026 -7/31/2027 Option 1 8/1/2027 -7/31/2028 Option 2 8/1/2028 -7/31/2029 Option 3 8/1/2029 -7/31/2030 Option 4 8/1/2030 -7/31/2031

DRAFT

Performance Work Statement (PWS): MiraVista Fungal Diagnostic Services

Part I: General Information

A. INTRODUCTION

The Richard L Roudebush VA Medical Center (RLR VAMC), Pathology and Laboratory Medicine Service, requires specialized fungal disease testing services for a base plus four (4), one-year, option years. Contractor shall perform all tests required herein and provide STAT testing within 8 hours, as required.

As Indiana's tertiary care facility, Indianapolis RLR VAMC receives referrals from VA facilities at Ft. Wayne and Marion, Indiana, and from several Community Based Outpatient Clinics (CBOC). The Microbiology/Serology Section of the RLR VAMC Laboratory is an integral part of the pathology department that performs infectious disease testing. The mission of the RLR VAMC laboratory is to complete diagnostic testing in support of patient care. Fungal disease tests that are outside the scope of the RLR VAMC’s capabilities are outsourced. The required laboratory tests are not performed in-house for reasons such as low testing volume, specialized equipment which is not available in-house and some of the required tests are proprietary laboratory developed tests (LDTs) by MiraVista.

Fungi can cause a variety of illnesses, the worst being pneumonia, systemic mycosis and fungal meningitis. The treatment for fungi infection is different than bacterial infection so quick accurate results to differentiate are necessary. The testing will be performed on serum, plasma, urine, bronchoalveolar lavage (BAL) or cerebrospinal fluid (CSF) specimens for RLR VAMC.

B. Scope of work Specimens must be picked up and delivered to the testing facility using the contractor’s own ground transportation services and tested within a specified time limit for specimen integrity. The Contractor shall provide commercial medical reference laboratory services.

The goal of this contract is to improve patient care by decreasing turn-around times, increasing efficiency within the lab and maximize cost effectiveness to the government; which will increase the quality of care received by patients at the RLR VAMC and associated facilities.

Part II: Requirements A. General Requirements The Contractor shall provide all the following fungal laboratory testing and analysis services specifically, quantitative antigen and antibody testing by enzyme immunosorbent assay (EIA) for the following required tests:

· Platelia™ Aspergillus Galactomannan EIA

· MVista® Histoplasma Antigen Quantitative EIA

· MVista® Blastomyces Quantitative EIA

· MVista® Coccidioides Quantitative EIA

· Fungitell® Beta-D Glucan Colorimetric Assay

· MVista® Histoplasma Antibody IgG, IgM EIA

· MVista® Pulmonary Fungal Pathogen Panel, PCR

· MVista® Pneumocystis DNA, PCR

· MVista® Histoplasma DNA, PCR

· MVista® Blastomyces DNA, PCR

· MVista® Coccidioides DNA, PCR

The Contractor shall be responsible for performing preanalytic processing, analysis, and result interpretation for clinical specimens as requested by RLR VAMC. Services shall include the pickup and transportation of clinical laboratory specimens to the contractor’s laboratory, the performance of analytical testing as defined by the Contractor’s reference test manual, the reporting of analytical test results, and consultative services as required to assimilate the full scope of its laboratory operations to the ordering facility.

The contractor shall provide a streamlined process and must be able to perform all fungal testing listed in the Price/Cost Schedule of this agreement.

Services shall be ordered by an ordering officer designation by the Contracting Officer. Results shall be delivered to the site designated via electronic transmission or fax on the task order and in accordance with standards, clauses, and provisions of this contract.

The Contractor shall be responsible for transporting the samples in such a manner as to ensure the integrity of the specimen.

The Contractor must ensure that employees providing customer services under this contract are able to read, write and speak English fluently, with sufficient clarity, to effectively communicate with personnel from the Government-owned laboratory when necessary.

The selected reference laboratory will be responsible for the security and integrity of specimens and for compliance with all Health Insurance Portability and Accountability Act (HIPAA) provisions.

Lab General Qualifications Only fully licensed and accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this Performance Work Statement (PWS) will be considered. The contractor shall have all licenses, permits, accreditations, and certificates required by law. The reference laboratory must be licensed and accredited by the College of American Pathologists (CAP) 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 Act of 1988.

The Contractor shall maintain current accreditation and notify the Contracting Officer of any lapse in state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certification. The Contractor shall provide a copy of the renewed licenses and certificates to the Contracting Officer before expiration.

The Contractor must ensure that all testing and supervisory personnel, including the Medical Director, assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the College of American Pathology (CAP) accreditation standards.

The Medical Director of the contracting facility must be a licensed Physician with suitable qualifications and experience to direct a laboratory in providing testing under this contract according to CLIA and CAP standards. The Contractor must submit a copy of the professional certification and licensure of the Laboratory Director and Medical Director to the COR with the proposal. Also copies of all certifications and licenses for the Technical Supervisors of the Primary Contractor’s laboratory must be submitted with the proposal.

The Contractor shall provide a copy of all relevant permits, licenses, and certificates 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 subcontractors performing services hereunder must meet the same requirements as the prime contractor. Proof of the above required certifications, accreditations, licenses, etc. must be furnished to the Contracting Officer Representative (COR). Any proposed subcontractor changes during the contract performance period must have prior approval by the Contracting Office (CO). Changes to the requirements will be executed by a bilateral modification to the contract.

All laboratory testing services must be rendered by individuals fully qualified by the Federal, State and local laws. The laboratory must hold all legally required licenses, certifications, and accreditations in accordance with Federal statutes and implement regulations and those of the state in which the laboratory is located.

Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA). Neither the Contractor, nor any of its employees, will disclose private medical information concerning patients to third parties other than those personnel designated by the Government to receive patient results. Results will be handled as private medical records.

Client Service personnel must be accessible by toll-free telephone to assist Government staff in tracking test results, modifying test requests, obtaining information regarding specimen requirements, requesting emergency courier service, using the provided computer system, and other applicable related issues or problems that may arise in the performance of work under this contract.

The Contractor must only conduct business with designated Government personnel listed as points of contact (POCs). Names of authorized personnel will be provided to the Contractor by the Government, in writing, and updated as necessary throughout the contract period.

The Contractor must designate and submit in writing the name and telephone number of a full-time contract manager and alternate to the Contracting Officer. The contract manager will be responsible for the satisfactory performance of the required services. They will meet, as necessary, with the RLR VAMC COR or designee to discuss immediate administrative, technical issues, and problem areas. The contract manager shall ensure all monthly invoices are reviewed for accuracy and delivered in accordance with the terms of this Statement of Work.

Malpractice Liability Insurance The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate to the Contracting Officer with a required insurance coverage of $1,000,000.00 per occurrence.

The Contactor shall notify the CO in writing of any malpractice investigation, licensure, or certification suspension which relate to the Contractor or any employees within 24 hours of notification of an investigation or suspension.

Specimen Tracking System and Notification Processes The Contractor shall promptly notify the ordering facility of lost or missing specimens or amended reports. A ten (10) business day notice shall be given to the ordering facility of any test changes via email or electronic communication.

Information to be provided by the Contractor includes:

· Test-specific specimen collection and preservation requirements for each test or analyte;

· Test-specific method and interpretation for each test or analyte;

· Test-specific method reference ranges, adjusted for age, sex, or race, when required;

· Test-specific method sensitivity and specificity, when required; and

· Test-specific schedule of performance and maximum turn-around-time for each test.

Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units). In the event of any change, this information will be provided to the COR at least 10 business days prior to the Contractor’s change. Changes to procedures with less than 14 days notice will be made only with the agreement of the Government COR.

In the event the Contractor changes the assay procedures or a critically important component of an assay, the Contractor shall notify the Contracting Officer and the COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the Contracting Officer. The Contractor is liable for excess procurement costs.

The Contractor shall provide the status of pending test results upon inquiry providing the direct phone numbers to the specific lab area and the laboratory location performing the test.

The Contractor shall notify the ordering facility via phone within two (2) hours of problem identification in the instances mentioned below to allow the ordering facility’s send out technologist to decide the best course of action for the sample.

· The sample is too short to run

· The sample does not give results due to sensitivity issues with the currently used test method.

· If the sample testing is delayed due to the current platform testing being “down.”

· The sample is rejected per customer service.

· Adding/Canceling Testing Contractor shall allow additional testing or "add-ons" to be ordered on specimens held in storage. Added tests are authorized via telephone with a follow-up faxed test request form. Contractor shall allow to cancel or change test request if necessary.

Procedure Guidelines The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. Upon request by the CO or COR, the Contractor will make available quality assurance information on specific testing procedures for review.

Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the Government unless otherwise indicated by the ordering facility’s personnel.

The Contractor shall whenever applicable or relevant make a distinction between tests that are FDA approved vs. research only use (RUO), in vitro diagnostic (IVD), investigational use only (IUO), life science research (LSR), or Emergency use authorization (EAU). In such cases, the distinction shall be printed on each result sheet.

Supplies The Contractor shall provide an electronic or paper laboratory user manual to include defined testing methodology and reference ranges for each test.

The Contractor shall provide all necessary supplies normally provided to its commercial customers, not limited to the following:

The Contractor shall contact the COR within a maximum of five (5) business days after award of task order or Blanket Purchase Agreement, to coordinate the furnishing and delivery of specimen collection and transportation, furnish written instructions to Government personnel for sample preparation, applying barcode labels, packing samples, preparing paperwork, and transshipping transport containers necessary to meet the requirements established under the terms of this contract.

Test Results The Contractor shall provide a courier to pick-up and transport the samples to the testing facility within the allowable time limits placed by the contracting facility. The results shall be telephonic and fax in accordance with the testing specifications defined in the Contractor’s commercial specimen collection guide, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day).

Routine Testing The Contractor shall provide routine test results to the ordering facility in accordance with the testing specifications defined in the Contractor’s commercial specimen collection guide, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day). Test procedures requiring a TAT longer than 48 hours (excluding the above exceptions) shall be identified by the Contractor before contract award and approved by the Contracting Officer.

Reporting of Results A report is defined as a printed final copy of laboratory testing results. This report shall be received by remote terminal where applicable. If results are previously telephoned, the report must include the name of the individual notified of the results.

Each test report shall at minimum indicate the following information:

Test results will be faxed to the Send-Outs Section direct, FAX: 317-988-4380. Any positive results on the following tests are a critical result and will be phoned to the main laboratory at 317-988-3134.

Specimen Retention Upon completion of the testing, the Contractor shall retain all specimens as required by regulatory agencies (RA). Upon request by the ordering facility COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the contractor shall retain specimens, after all testing has been completed: clinical specimens seven (7) days.

Documentation The Contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the contractor personnel’s own signature to the documents and validating their contents.

Service and Maintenance The account representative or consultant must be available telephonically, or in person by appointment, as needed, to help troubleshoot, service the account, and introduce new tests, etc.

The Contractor shall provide telephone number(s) and contact person to be used by the ordering facility to make specimen problem inquiries and problem solving at all times including weekends and holidays. The Contractor shall include names and telephone numbers of the technical directors and pathologists available for consultation.

The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to the ordering facility upon adverse action by a regulatory agency. The Contractor shall advise the ordering facility with a two (2) week advanced notice of any changes in methodology, procedure, reference ranges and any new tests introduced.

In the event that the contractor changes the assay procedure or a critically important component of an assay, the Contractor shall notify the Lab prior to the intended change. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the CO.

Contract Quality Assurance/Quality Control The Contractor Facility’s methodologies (defined as the principal of the method and the references) and quality control procedures may be examined by representatives of the government at any time during the life of the contract.

The Contractor shall comply with all applicable OSHA, Federal and State laws and regulations as required for performing the type of services required.

Delivery Specimen Pick-up Times The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the ordering facility.

The ordering facility COR or designee shall notify the Contractor during weekends and Federal Holidays, via telephone, when a pick-up courier is required.

The Contractor shall send a courier to check and log all samples before leaving the shipping area. The test list/requisition/work document will contain pertinent shipping information and patient demographics required by the Contractor. The Contracting Courier shall provide:

· For proper transporting of specimens under required conditions to ensure viability for testing.

· Possess applicable training to meet bloodborne pathogen and IATA/DOT regulations for transport of biological and infectious specimens.

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Sources Sought Notice