36C26226Q1347.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Contract Specialist Diaz, Marcos Marcos.Diaz@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

THIS REQUEST FOR INFORMATION (RFI) – SOURCES SOUGHT IS ISSUED SOLELY FOR MARKET RESEARCH AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION.

ON DEMAND/ON SITE TECHNICAL SUPPORT FOR PREVENTIVE MAINTENANCE INSPECTIONS AND CORRECTIVE REPAIRS

1. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research only to make appropriate acquisition decisions and to gain knowledge of Small Business Capability, including Service Disabled Veteran Owned Small Businesses and Veteran Owned Small Businesses (SDVOSB/VOSB) interested and capable of performing the work.

2. The NAICS for this requirement is NACIS 621511 – Medical Laboratories.

3. Interested and capable Contractors should respond to this notice not later than 07:00AM PST on 18 Aug 2026. by providing the following via email only to Diaz, Marcos, Contract Specialist, at Marcos.Diaz@va.gov.

Use Sources Sought # 36C26226Q1347 on all correspondence for this Sources Sought.

The results of this market research will assist in the determination if a set-aside is in the best interest.

Please provide the applicable information below:

Company Name:

DUNS Number:

Address:

Point of Contact Name:

Phone No:

Email:

Business size information

Select all that applies:

Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HubZone Woman Owned Certified Service-Disabled Veteran Owned Small Business (registered in VetBiz.gov) Veteran Owned Small Business (registered in VetBiz.gov)

FSS/ GSA Contract Number

Effective Date / Expiration Date

NASA SEWP Contract Number

Effective Date / Expiration Date

4. SDVOSB/VOSB respondents.

Please indicate if you would utilize a subcontractor in performing the requirement and supply the information below. Yes ☐ No ☐ Please complete this information for sub-contractor.

Company Name:

DUNS / UEI Number:

Address:

Contact Name:

Phone No:

Email:

Sub- contractor Business size information

Select all that applies:

Small Business Emerging Small Business Small Disadvantaged Business Certified under Section 8(a) of the Small Business Act HubZone Woman Owned Certified Service-Disabled Veteran Owned Small Business (registered in VetBiz.gov) Veteran Owned Small Business (registered in VetBiz.gov)

Statement of Work:

1. OBJECTIVE

The specific objective of this contract is to award a single Blanket Purchase Agreement (BPA) contract to provide Semen analysis and post vasectomy testing on samples provided using a unique mail-in kit collection system. The reference laboratory testing will be for all facilities within Health Service Area (HSA) 5.3 (previously known as HSA 5.3 ).

The Contractor shall provide the following services to each healthcare system:

A. Sample Processing: Provide specimen collection materials, appropriate transportation, and storage of specimens to ensure specimen integrity for all test orders. Safety Data Sheets will be provided to sites as appropriate for supplies containing hazardous chemicals.

B. Business Review: Provide a statistical analysis of the HSA 5.3 facilities’ workload test volumes and assist in the monitoring of ordering trends and utilization patterns.

C. The contractor will provide full test kits, logistical support for patients, and reporting tools for clinicians. This service includes:

1. Mail-in semen analysis kits validated for room temperature stability up to 52 hours.

2. Post-vasectomy testing kits with unlimited retesting until absence of sperm is resulted in subsequent semen specimens.

3. Full clinic portal access for reviewing and uploading results to EHR.

4. Replacement kits at no charge if test results are delayed or invalid or kits are expired.

2. SCOPE OF WORK

HSA 5.3 is comprised of VA Medical Centers, VA Outpatient Clinics (OPC), and VA Community-Based Outpatient Clinics (CBOC). Services provided to HSA 5.3 under the resultant BPA contract shall include shipping of specimens to the Contractor’s laboratory(s), the performance of analytical testing as defined by the Contractor's reference test manual, the reporting of analytical test results and business review services HSA 5.3 laboratory operation.

All requirements and provisions defined in the specifications of this solicitation apply to any laboratory (i.e. branch, division, sub-contractor, etc.) performing reference testing on behalf of the Contractor.

It is possible that during the life of this contract that HSA 5.3 might add additional facilities within the California, Arizona, or New Mexico geographic areas that will require the services specified in the Statement of Work. The Government shall have the right to unilaterally modify this BPA contract to add any new facilities in those geographic areas during the BPA period of performance and the Contractor shall provide the services described in the Statement of Work to those facilities. The prices charged for services provided to any new facilities shall adhere to the prices agreed upon should an award be made to an offeror after a valid solicitation. When additions occur, a modification to the BPA will be executed notifying the Contractor of the new facility to be serviced.

3. PARTICIPATING HSA 5.3 HEALTHCARE SYSTEMS

VA LONG BEACH HEALTHCARE SYSTEM

5901 E. Seventh St Long Beach, CA 90822

VA LOMA LINDA HEALTHCARE SYSTEM

11201 Benton Street Loma Linda, CA 92357

VA SAN DIEGO HEALTHCARE SYSTEM

3350 La Jolla Village Drive San Diego, CA 92161

VA GREATER LOS ANGELES HEALTHCARE SYSTEM

11301 Wilshire Blvd.

Los Angeles, CA 90073

VA ALBUQUERQUE HEALTHCARE SYSTEM

1501 San Pedro Dr. SE Albuquerque, NM 87108

VA NORTH ARIZONA HEALTHCARE SYSTEM

500 AZ-89

Prescott, AZ 86301

VA PHOENIX HEALTHCARE SYSTEM

650 E Indian School Rd.

Phoenix, AZ 85012

VA SOUTHERN ARIZONA HEALTHCARE SYSTEM

3601 S 6th Ave.

Tucson, AZ 85723

4. DESCRIPTION OF SERVICES

A. SAMPLE PROCESSING: Each facility will provide properly prepared laboratory specimens, identified and labeled for testing. The Contractor shall provide an adequate supply of specimen collection materials for such testing, including all materials required for specialized handling as dictated by the Contractor’s reference laboratory's specimen collection requirements, (e.g. dry ice, stabilizing tablets, ice packets, etc). The Contractor shall transport and store specimens in such a manner as to ensure the integrity of the specimen. The Contractor shall provide additives required for collection of specimens in unit packages to facilitate collection at Community Based Outpatient Clinic’s (CBOC) and Outpatient Clinics (OPC). Material Safety Data Sheets will be provided by the Contractor to sites as appropriate for supplies containing hazardous chemicals (e.g. boric acid tablets, acids).

B. SPECIMEN TESTING: The Contractor shall provide testing of patient specimens as requested by HSA 5.3 facilities.

C. FAR 52.212-4(c) CHANGES: SOW: Services determined by the Contracting Officer to be within the general scope of the contract or PRODUCT ADD-ON: The VA may have a need for additional testing over the life of the contract that are not currently on the Price Schedule or FACILITY: The VA may add any new location incorporated into HSA 5.3 . Any of these changes shall be made in accordance with FAR 52.212-4(c) Changes, shall not necessitate new solicitation proceedings.

5. PATIENT TEST REPORT

A patient test report is defined as a printed final copy of laboratory testing results or host-to-host VPN electronic transmission of test results. This report will be received by VPN computer interfaced to the VistA Laboratory Package. Contractor shall make all results retrievable via Secure Web Portal; in addition to providing the Web Portal, Contractor may send also send results via fax to a secure facsimile. Specifications outlining the requirements of the computer interface to the VistA Laboratory Package, including computer hardware, maintenance and supply requirements are defined in Section B.14 Technical Data Requirements – B. Interface Telecommunication Requirements.

A. PATIENT TEST REPORT: At a minimum, the Contractor shall provide the following information on each laboratory test report/result:

1. Patient's name

2. Date of Birth

3. Test ordered

4. Date/time of specimen collection

5. Date/time test completed

6. Test result

7. Reference intervals

8. If applicable, toxic and therapeutic ranges

9. Flagged abnormal

10. Critical Value

11. Reference laboratory specimen number

12. Name and address of testing laboratory

13. Any other information that may indicate a questionable validity of test results

14. Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing The Contractor shall provide test results, either by hard copy or electronic report transmission via electronic portal or fax to each site.

B. CLIENT SERVICES: Contractor shall provide Client Services for at least 8 hours per day, Monday through Friday to address inquires such as test availability, specimen collection, storage, transport requirements, addition or cancellation of testing, and the ordering of supplies. During normal business hours, the Contractor shall provide access to medical experts to address laboratory test interpretation, testing recommendations, and education regarding testing options.

6. ADMINISTRATIVE REPORTS - MONTHLY

MONTHLY REPORTS: The Contractor shall provide the reports listed below in a downloadable Excel format. Each healthcare system shall receive a facility specific report and HSA 5.3 Leadership shall receive a single cumulative document to include all HSA 5.3 healthcare system.

A. TEST UTILIZATION REPORT: Contractor shall provide a statistical analysis of the HSA 5.3 facilities workload testing volumes to assist in the monitoring of ordering trends and utilization patterns. The analysis shall include:

1. Tests performed

2. Test Order Code

3. Test volumes

4. Associated cost per test

7. BUSINESS REVIEW REPORT:

A. BUSINESS REVIEW: The Contractor shall provide an annual business review in downloadable MS Excel format. Each healthcare system shall receive a facility specific report and HSA 5.3 Leadership shall receive a single cumulative document to include all HSA 5.3 healthcare system.

8. REQUIREMENT FOR SHIPPING SERVICES

A. GENERAL

The Contractor shall provide CLIA certified and FDA registered prepackaged mail-in kits for which Contractor provides laboratory services.

1. All report data the Contractor exports and submits to the facility shall be Health Information Portability and Accountability Act (HIPAA) compliant.

2. Gel packs included to stabilize and maintain temperature within the test kit. Summer and winter packs are used for seasonality.

3. Non-Toxic preservative used in transport kits.

4. Able to store kits at room temperature.

B. DESCRIPTION OF SERVICES

1. To procure semen analysis and post-vasectomy mail-in testing kits. The contractor will provide full test kits, logistical support for patients, and reporting tools for clinicians. This service includes:

a. Mail-in semen analysis kits validated for room temperature stability up to 52 hours.

b. Post-vasectomy testing kits validated for room temperature stability up to 7 days, with unlimited retesting until absence of sperm is resulted in subsequent semen specimens with full semen analysis after the 3rd attempt.

c. Full clinic portal access for reviewing and uploading results to EHR.

d. Replacement kits at no charge if test results are delayed or invalid or kits are expired.

2. Reportable Parameters

a. Post-Vasectomy analysis

· Volume in mL

· Concentration of Azoospermia in cells/mL

· Count of Azoospermia in cells/ejaculate

· To include centrifuged specimen analysis in cases of cryptozoospermia.

b. Semen Analysis

· Total motility in millions/ejaculate

· Volume in mL

· Concentration in millions/mL

· Motility in %

· Morphology in %

· Total count in millions/ejaculate

9. REQUIREMENTS

1. The Contractor shall provide safe transport of all biological substances. This shall include the proper receipt, distribution, storage and security of patient specimens in accordance with all federal regulations governing the safe transport of these materials including the following, which are incorporated herein by reference:

a. Department of Transportation 49 CFR Parts 171-180 – Hazardous Materials: Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule.

b. Department of Health and Human Services 42 CFR Parts 72 and 73 – Interstate Shipment of Etiologic Agents and Select Agents and Toxins

c. Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens

d. HIPAA Privacy Rule 45 CFR Parts 160 1nd 164.

2. Contractor shall comply with all state and local regulations that are applicable to the services it provides.

3. The Contractor shall implement procedures that ensure the accountability and integrity of all biological substances from the point of possession to the point of delivery.

4. The Contractor shall ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging and environmental control procedures suitable to specimen type and distances transported.

5. The Contractor shall provide an adequate supply of materials necessary for the efficient, organized and coordinated receipt, transport, and delivery of specimens (e.g. bags, temperature condition stickers, transportation receipt forms, rigid-sided containers, dry ice, coolers, incubators, etc.). Upon request, the Contractor shall provide temperature integrity tracking data.

10. SPECIFICATIONS

B. LICENSURES: Contractor shall perform specimen testing only in fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing described in this BPA contract. The reference laboratory must be licensed/accredited by the College of American Pathologists (CAP) as well as any other state regulatory agencies as mandated by federal and state law. In addition, the Laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA) and VA Directives 1106, 1106.01 and 1106.2 For each laboratory used, Contractor shall provide copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America.

As these documents are reissued or reworded, the Contractor shall supply a copy to the Contracting Officer and each HSA 5.3 facilities. The above documents must also be supplied for each reference laboratory that is a subcontractor of the Contractor.

11. SECURITY

A. DATA SECURITY REQUIREMENTS

The Contractor shall be responsible for the security and integrity of specimens and for the compliance of all Health Insurance Portability and Accountability Act (HIPAA) provisions. Additionally, the Contractor shall be afforded access to the HSA 5.3 VistA and shall be responsible for ensuring the proper credentialing of employees interacting with HSA 5.3 personnel. Contractor shall adhere to all Information Technology Security requirements as set forth in VA Handbook 6500.6, which is incorporated herein by reference; vendor shall adhere to Appendix C and Appendix D and submit proper documentation as required.

B. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor shall adhere to the security requirements in the approved MOU/ISA established between the Contractor and VA.

12. GENERAL INFORMATION

A. CONTRACTOR’S PROGRAM MANAGER: The Contractor shall provide a Program Manager who shall be responsible for managing the performance of work. The name of this person shall be designated in writing to the Contracting Officer. The Contractor’s program manager shall have full authority to act for the Contractor on all matters relating to daily operations of this contract.

Name:

Address:

Phone No.:

Fax No.:

Email:

B. CONTRACTOR EMPLOYEES: The Contractor shall not employ any person for work on this contract if such employee is identified to the Contractor as a potential threat to the health, safety, security, and general well-being of the public.

13. PERIOD OF PERFORMANCE

End of Statement of Work

Please note that if VA’s pending market research establishes that two or more VOSB or SDVOSB, who are certified in the Small Business Administration website at SBA - Dynamic Small Business Search, can perform the services, VA will set aside the underlying solicitation per 38 U.S.C. §8127.

All Offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) database found at https://www.sam.gov. Registration must include Representations and Certifications.

--End of Sources Sought Announcement--

Sources Sought Notice