Q301-- Organ Donor Blood Testing New Requirement -VA Pittsburgh Healthcare System

SOURCES SOUGHT NOTICE: The Department of Veterans Affairs, Network Contracting Office 4 (NCO 04), is conducting a market survey to identify potential sources to provide HIV-1/HCV/HBV NAT and West Nile virus (PCR) testing on blood samples for the VA Pittsburgh Healthcare System (VAPHS) University Drive Campus, 4100 Allequippa St., Pittsburgh, PA 15240.

This notice is issued for informational planning purposes only and is not a request for quote or announcement of a solicitation. Submitting information for this notice is voluntary and VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice. No solicitation is available at this time. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.

The purpose of this market research is to identify capable sources that are both experienced and qualified to provide HIV-1/HCV/HBV NAT and West Nile virus (PCR) testing on blood samples sent by the VA Pittsburgh Healthcare System in accordance with statement of work. THE VENDOR MUST BE LOCATED WITHIN A 50-MILE RADIUS OF THE VA PITTSBURGH SO THAT SAMPLES CAN BE DELIVERED AND TESTING PERFORMED WITHIN 24 HOURS.

The North American Industry Classification System Code (NAICS) is 621511 Medical Laboratories, and the small business size standard is $41.5 million for this type of effort.

Vendors must be registered in the System for Award Management (SAM) at https://www.sam.gov and shall complete electronic annual representations and certifications in SAM prior to award of contract. If you are responding as a Service-Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses (SDVOSB s and VOSB s), your company must be registered in VETBIZ and maintain a current certification (https://www.vetbiz.va.gov).

CAPABILITY STATEMENT AND DOCUMENTATION:

Companies are to provide a summary of your firm s capabilities, experience, and knowledge in providing these services. Sources are asked to provide the following information:

1. Company information:

Company Name

Company Address

Company uei SAM

Company NAICS Code(s)

Point of Contact Name

Point of Contact Phone Number

Point of Contact Email Address

Company Website (if available)

2. The North American Industry Classification System Code (NAICS) is 621511 Medical Laboratories, and the small business size standard is $41.5 million.

Based on this information, please indicate whether your company is a:

Service Disabled Veteran Owned Small Business (SDVOSB)

Veteran Owned Small Business (VOSB)

8(a)

HUB Zone Small Business

Women Owned Small Business

Small Disadvantaged Business (SDB)

Small Business Concern

Large Business

3. Provide a summary of your firm s Ability/ Capability to meet the services described in this notice (see attached SOW).

4. Government contracts for these services in the last 3 years. Include:

Government Agency

Contract Number

Dollar Value

Period of Performance

Government Point of Contact Information (name, email, phone number)

Information regarding your company s capacity and capability to provide such services are to be submitted electronically on or before Monday, 02/20/2023 addressed to Christa Stine, Contract Specialist christa.stine@va.gov.

DRAFT/DESCRIPTION/SPECIFICATIONS/WORK STATEMENT (SOW)

Statement Of Work: HIV-1/HCV/HBV NAT and West Nile virus (PCR)

General Scope:

The vendor shall perform HIV-1/HCV/HBV NAT and West Nile virus (PCR) testing on blood samples sent by the VA Pittsburgh Healthcare System. The VA Pittsburgh Pathology and Laboratory Medicine Service department is seeking these tests. The HIV-1/HCV/HBV NAT test is a panel that includes 3 assays: human immunodeficiency virus (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV). West Nile virus (PCR) testing will also be performed along with the before mentioned panel. All assays will be run on the patient sample that is sent to the vendor.

Blood samples labelled with at least two patient identifiers will be submitted by the VA Pittsburgh laboratory in sterile red top vacutainer tubes with no additives and purple top vacutainers containing EDTA as an anticoagulant. The samples will be shipped directly to the vendor from the VA Pittsburgh processing department.

Results will be faxed to the VA Pittsburgh at 412-360-1075 within one business day upon receipt of sample.

Vendor must be CLIA, FDA and PA Department of Health certified during the time frame of this agreement.

Testing must be available on a 24/7 basis.

The vendor must be located within a 50-mile radius of the VA Pittsburgh so that samples can be delivered, and testing performed within 24 hours.

Estimated Usage

Description of Services

Annual Quantity

Unit

NAT Panel (Ultrio)

20

Each

West Nile Virus (PCR)

20

Each

Vendor Information Requirements:

Patient information (pursuant to all regulations dealing with patient privacy) will be provided at the time of the order. This information will be used to calculate usage for billing and submitting test results. Vendor agrees to notify the point of contact (POC) who is the Ancillary Testing Supervisor, of any changes to testing information including, but not limited to, reference ranges, sample requirements or delays in testing. Vendor will work with POC to schedule any required training or education.

Government Furnished Property:

The government will furnish no property to the vendor.

Term Of Contract:

This will be a one-year base contract beginning 08/01/2023 with four, one year option years. No service shall be performed by the contractor after the end date until the Contracting Officer authorizes such services in writing.

Legal Requirements Related to Medical Records/Privacy And Confidentiality:

Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security, use, and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).Â

Records created by the Contractor in the course of treating patients under this contract are the property of VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.

The treatment and administrative patient records created by, or provided to, the Contractor under this contract are covered by the VA system of records entitled Patient Medical Records VA (24VA19), which is available at http://www.rms.oit.va.gov/SOR_Records/24VA19.asp

The Contractor is required to comply with Title 48 of the Code of Federal Regulations, Part 24.101-24.104 Protection of Privacy and Freedom of Information . When responding to a veteran s request that copies of records is released to a third party, the Contractor shall refer the veteran to VA for release of records. The Contractor is responsible for complying with VHA, Joint Commission, HIPAA, and other applicable external regulatory agency regulations.

Neither the VA nor the Contractor has the legal authority to require that a patient provide his/her Social Security Number to the VA as a condition for receiving medical care under Title 38, United States Code. If the patient does not provide a Social Security Number, the VA will assign a unique identification number to the patient.

Delivery Location

Patient results are to be faxed to 412-360-1075

Pittsburgh Healthcare System

University Dr

Pittsburgh, PA 15240