36C25227Q0071.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

36C252 115 South 84th Street, Suite 101 Milwaukee WI 53214-1476

POINT OF CONTACT*

Joni Dorr Contracting Officer

PLACE OF PERFORMANCE

FHCC

3001 Green Bay Road

North Chicago IL

ADDITIONAL INFORMATION

SOURCES SOUGHT SYNOPSIS

The Department of Veterans Affairs is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support a requirement for Blood Don Services for the following Veterans Integrated Service Network (VISN) 12 facility: Captain James A. Lovell Federal Health Care Center (FHCC) in North Chicago, IL. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 621511 – Medical Laboratories.

THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred.

Requirements:

Provide blood donor panel testing services to meet regulations set forth by the Food and Drug Administration (FDA), Association for the Advancement of Blood & Biotherapies (AABB), College of American Pathologists (CAP), The Joint Commission (TJC), Occupational Safety and Health Administration (OSHA), Center for Disease Control (CDC) and Prevention, and Department of Defense Instruction (DoD Inst). See Statement of Work on the following page for details.

If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address if applicable, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort and documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

The government will evaluate market information to ascertain potential market capacity to provide services consistent in scope and scale with those described in this notice and otherwise anticipated.

BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES, SOLE SOURCED OR PROCURED THROUGH FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 10:00am Local (Central) Time on November 3, 2026. All responses under this Sources Sought Notice must be emailed to joni.dorr@va.gov.

Statement of Work Blood Donor Panel Testing

Captain James A. Lovell Federal Health Care Center (FHCC), located at 3001 Green Bay Road, North Chicago, IL requires blood donor panel testing services, as detailed in the Blood Donor Panel Testing section, to meet regulations set forth by the Food and Drug Administration (FDA), Association for the Advancement of Blood & Biotherapies (AABB), College of American Pathologists (CAP), The Joint Commission (TJC), Occupational Safety and Health Administration (OSHA), Center for Disease Control (CDC) and Prevention, and Department of Defense Instruction (DoD Inst). The Contract shall be a five (5) year Ordering Period with five (5) one-year priced periods to be tasked off of at the discretion of the Government.

SCOPE

Contractor shall provide all labor, expenses, materials, tools, test equipment, analytical testing, supervision, expertise, and travel necessary to provide blood donor panel testing services. Any and all travel required by the Contractor to complete blood donor panel testing shall be covered by this Contract and shall not be separately charged to the Government.

CONTRACT ORDER PERIOD

Contract shall be a five (5) year Ordering Period with five (5) one-year priced periods.

CONFORMANCE STANDARDS AND LICENSURE

Contractor shall continuously hold current and valid Government licenses, permits, and approvals as required by FDA, CAP, Clinical Laboratory Improvement Amendments (CLIA), AABB, and/or other State regulatory agencies as it pertains to transporting/testing samples, and the reporting of specified tests to include infectious diseases, as appropriate, and as mandated by federal and state statutes. Contractor shall maintain valid certifications during the performance period of this Contract. All current permits, licenses, and certifications copies of the Contractor and if applicable, subcontractor shall be provided via email to the Contracting Officer Representative (COR) or designee(s) upon award and upon recertification, if applicable.

Contractor shall notify the Contracting Officer’s Representative (COR) or designee(s) in writing within twenty-four (24) hours, upon its loss of any required certification, accreditation or licensure.

Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification and ensure all laboratory testing staff comply with minimum Federal, State, and local law qualifications and requirements.

Contractor shall ensure all testing and supervisory personnel at all Contractor-owned, affiliate, or subcontracted laboratories assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations’ and State standards.

BLOOD DONOR PANEL TESTING AND ESTIMATED QUANTITIES

Anti-HIV1,O/HIV 2, p24 Combo Hepatitis B Surface Ag Anti-Hepatitis B Core Anti-HTLV 1/HTLV 2 Serologic Test Syphilis Anti-Hepatitis C Virus 2.0 ABO & Rh Typing Red Cell Alla-Antibody Screen HBV, HCV, HIV by mini pool NAT

31,000 (6,200/YR)

REQUIRED TASKS

Failure to provide services as indicated in Statement of Work may result in an unacceptable performance evaluation.

General

1. Contractor shall provide specimen shipment containers at their cost, including transportation, to the FHCC.

2. FHCC shall provide transportation/courier services of prospective donor/patient specimens to the Contractor.

3. Contractor shall perform analytical testing of samples within the specified timeframe.

4. Contractor shall provide reports on analytical test results within the specified timeframe.

Description of Test Information

1. Contractor shall make available either through electronic catalog or upon request the following information:

a. Requisition form requirements

b. Alphabetized test name list

c. Test order code

d. Specimen collection and preservation requirements

e. Test method employed (indicate if testing performed in duplicate) and interpretations

f. Test specific sensitivity, specificity and interferences, when required

g. Result code

h. Test critical values, if any

i. Policy for critical value notification

j. CPT coding

k. Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of the specimen shipment container by the Contractor and receipt of results reports by FHCC.

l. Schedule of test performance (specific days of week indicated)

m. Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory shall be cited).

2. Contractor shall notify the Contracting Officer’s Representative (COR) or designee(s) via email more than thirty (30) calendar days prior to any modifications to the required testing.

3. The Contractor shall provide product information on new test(s) offered by the Contractor. Updated test information shall be provided to the COR or designee(s) via email once test validation is complete.

Specimen Preparation and Storage for Blood Donor Panel Testing

1. Contractor shall provide the Contracting Officer’s Representative (COR) or designee(s) via email with the test manufacturer’s specimen preparation and storage requirements prior to the start of the contract to ensure proper specimen handling.

2. Upon receipt of the specimen shipment container, Contractor shall be responsible for handling and storing specimens in such a manner to ensure the integrity of the specimen and suitability for testing according to the test manufacturer’s specimen preparation and storage requirements.

3. FHCC shall label each set of donor specimens with a unique Donation Identification Number (DIN).

Blood Donor Panel Testing

1. Contractor shall provide the full range of clinical testing capabilities to execute required blood donor panel tests, including new and updated panels, if applicable. All blood donor panel testing shall be executed in accordance with standard industry practices.

2. All test methods shall be FDA approved. Any non-FDA approved method being performed shall have a documented validation plan submitted to the COR or designee(s) via email more than thirty (30) calendar days prior to implementation. When validation is completed, the validation results shall be submitted to the COR or designee(s) via email.

3. Contractor shall ensure the accurate and timely performance, as defined in Reporting of Results section, of blood donor panel testing services on specimens provided by FHCC.

4. Contractor shall notify the FHCC Donor Center leadership team via email (contact information shall be provided to Contractor upon award of contract) of specimens cancelled due to unacceptability (e.g. volume, specimen container, identification, loss of specimen) within twenty-four (24) hours of receipt of specimen shipment container.

Reporting of Results

1. Each test report shall include laboratory testing results in both of the following formats:

Format 1. Example Test Results Report

Format 2. Example Data Transfer File

2. Test result files shall be delivered to the FHCC Donor Center leadership team via email (contact information shall be provided to Contractor upon award of contract) within the prescribed timeframe stated below

a. Blood Donor Panel Testing – within twenty-four (24) hours of receipt of the specimen shipment container

b. Confirmation Testing – within seven (7) calendar days of the initial reactive result.

PERFORMANCE STANDARDS

Performance standards of the Contractor shall be evaluated by the COR. Performance standards to be evaluated shall include quality aspects representative to the testing processes of pre-analytical, analytical, and post-analytical variables and shall include a description of monitoring and evaluation activities. All services performed under this contract shall meet the performance standard showing 95% of tests are resulted and reported within twenty-four (24) hours of receipt of specimen shipment container.

HOURS OF OPERATION

FHCC shall ship specimens to the Contractor Monday through Friday via priority overnight commercial courier service at FHCC expense and shall be received by the Contractor Tuesday through Saturday, with weekend and National Holidays included to ensure performance standards are met.

Contractor shall have a Point of Contact (POC) available via phone and email to address any issues that may arise during normal business hours, Monday through Friday, 7:00am – 3:30pm Local (Central) Time, excluding Federal Holidays, which include:

Independence Day

Any other day specifically declared by the President of the United States to be a Federal Holiday When one of the above designated legal holidays falls on a Sunday, the following Monday shall be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday shall be observed as a holiday by U.S. Government agencies.

Contractor must respond by phone or email to the COR or designee within sixty (60) minutes after receiving telephone notification.

NEW PANELS

If new or updated blood donor panels are required, these panels may be added to the contract as needed upon notification of the Contracting Officer (to be documented in writing via contract modification). All blood donor panel testing services shall be considered within scope for bilateral modification.

IMPLEMENATION OF SERVICES AND INSPECTION

Services shall begin upon award period of performance start date. Failure to provide timely implementation may result in grounds for termination of the contract. Contractor shall provide name(s) and telephone number(s) of Contractor employees who shall serve as a point of contact throughout the contract performance period upon award and within one (1) business day of a replacement to the COR via email.

FHCC Blood Donor Center Executive Management, the Navy Blood Program Office, and the Armed Services Blood Program Office reserves the right to physically inspect the Contractor facility at any time during the award period to ensure the Contractor’s compliance with accreditation and quality assurance practices and requirements. FHCC shall not be liable for any expenses incurred by the Contractor as a result of these inspections.

Sources Sought Notice