Q515--Renal Biopsy- Nephropathology 4 year IDIQ

This is a SOURCES SOUGHT notice for market research purposes only to determine the availability of qualified small business, woman-owned small business, HUBZone, small disadvantaged, Veteran-owned small business (VOSB), or service-disabled Veteran-owned small business (SDVOSB) sources capable of providing the full range of services described below. This is NOT a request for proposals or quotes. Responses should be provided via email to Melanie.Hawley@va.gov no later than 2 pm central time on August 21, 2023 (no telephone responses) with Subject line to include Response to 36C25623Q1712. Responses will be used to determine the appropriate acquisition strategy for a potential future acquisition; therefore, responses should provide clear and convincing evidence of capability and qualification to provide/perform the identified services. Please clearly identify any information to be considered sensitive or proprietary. Respondents will not be notified of the results of the market research.

PROVIDE: STAT Renal Transplant Biopsy Services for the Department of Veterans Affairs, Southeast Louisiana Veterans Health Care System (SLVHCS) located at 2400 Canal Street, New Orleans, LA 70119. Contractor must be fully licensed and accredited laboratory in full compliance with CLIA regulations. Below are sections of the Statement of Work:

SCOPE

The Contractor shall be able to provide all listed supplies for sample collection and shipment.

The Contractor shall provide door to door courier packaging and pick up of testing samples. This will be on a Monday-Friday basis, including emergency weekend and holiday services if needed. Schedule changes (including but not limited to Vendor holidays) must be agreed upon by the SLVHCS P&LMS Anatomic Pathology Supervisor in advance.

Routine, primary mechanism for test result reporting shall be by secure fax (number provided after award) located in the Pathology and Laboratory Medicine Service. Vendor will discuss results of case with submitting Pathologist by phone. Access to a web portal for complete case review shall also be available.

The Contractor shall perform to the standards in this contract.

SALIENT CHARACTERISTICS: STAT Renal Transplant Biopsy Services

All testing performed must be FDA approved.

All testing must be performed according to the manufacturer s instructions or, changes to manufacturers instructions have been appropriately validated and documented as required by accrediting agencies.

All Biopsy Services performed under this agreement shall be performed at the Contractor s submitted CLIA Accredited Laboratory.

Testing:

Status of Ordered Testing inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

Technical Expertise:

Test utilization inquiries where information is required as to appropriate use of the test shall be addressed within two business hours of initial call.

Result interpretation inquiries shall be addressed within four business hours of initial call.

Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

Information Technology Expertise for questions or issues regarding LOINC and test codes, reports and website assistance.

Renal Transplant rejection is a potentially life-threatening condition for the Veteran patient which requires STAT review and STAT reporting of biopsied renal tissue in order to provide guidance on treatment of transplant patients. Nephropathology is a rare specialty that is difficult to find commercially.

Due to the urgent nature of this requirement, contractors will be required to demonstrate their ability to provide services with their response to this notice. New contract award is expected to be prior to October 1, 2023, as current services expire September 30, 2023. The Government anticipates making a firm-fixed price contract for this requirement for four (4) years. This will be procured using FAR 13.106 Simplified Acquisition Procedures.

The NAICS code applicable to this notice is 621511, Medical Laboratories, and the small business size standard applicable is $41.5 Million.

INTERESTED CAPABLE SOURCES TO PROVIDE:

1) Company name, address, point of contact, phone number, e-mail address, tax Id, DUNS number, SAM UEI number.

2) SAM registration and/or ORCA as evidence of size status.

3) Veteran-Owned/Service-Disabled Veteran-Owned Small Businesses, evidence of registration in Veteran Small Business Certification (sba.gov) if applicable.

4) GSA/FSS Schedule contract, if applicable.

5) Brief capability statement (no more than 5 pages) with enough information to clearly demonstrate the capability to provide the full range of required services, and information on past performance providing recent and relevant services.

6) In the event that a set-aside procurement for VOSB or SDVOSB concerns is determined the appropriate acquisition strategy for a potential future acquisition, provide information on capability to adhere to VAAR Clause 852.219-75 or 852.219-76 (http://www.va.gov/oal/library/vaar/), (i.e., contractor will not pay more than 50% of the amount paid by the government to it, to firms that are not verified VOSBs/SDVOSBs-refer to paragraph 3 above), as applicable.

Identify any other companies owned (wholly or in part) by the owners of this business who provide services under the same or a related NAICS code.

Identify any other companies owned (wholly or in part) by the owners of this business who provide services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); provide the certification type (SDVOSB/VOSB), Federal Identification Numbers, and state of incorporation for each.

Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? YES _______ NO ________ If yes, please identify which companies are considering a Joint Venture and the ownership of each company.

DISCLAIMER

This Sources Sought Notice (SRC) is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this SRC that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this SRC.