36C26220Q0454-002.docx

Statement of Work- Greater Los Angeles Healthcare System

1. Introduction

The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to the VA Greater Los Angeles Healthcare System and VA Long Beach Healthcare System for IHC slide preparation.

1.1 Background

VA Greater Los Angeles Healthcare System and VA Long Beach Healthcare System are part of the Desert Pacific Healthcare Network (VISN 22), and is one of the most diversified tertiary health care providers in the VA. It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research. It also boosts one of the largest and most diverse patient populations in the VA system.

The Department is currently implementing new instrument for IHC testing. This is a very difficult and time-consuming task as each antibody requires validation. Until the instrument within the department has been fully validated the section requires outside assistance in completing the IHC slides.

2. Scope

Estimated Period of Performance.

Base year: 05/01/2020 – 04/30/2021 Option 1: 05/01/2021 – 04/30/2022 Option 2: 05/01/2022 – 04/30/2023 Option 3: 05/01/2023 – 04/30/2024 Option 4: 05/01/2024 – 04/30/2025

The contractor will be responsible for the following:

1. Contractor shall pick up prepared patient material from the Anatomic Pathology department located at 11301 Wilshire Blvd. Los Angeles, CA 90073 and 5901 East 7th St. Long Beach, CA 90822.

2. Contractor shall provide prepacking and shipping material to send slides for processing specimens.

3. Contractor shall prepare Global IHC/ISH/Special stain, PDL1 along with Pathologist interpretation.

4. Contractor shall prepare the IHC/ISH/Special Stain slides as indicated by the selections on the pre-filled requisition forms that include all service identified in the schedule.

5. Contractor shall receive IHC specimens and provide IHC slide making and staining services.

6. Contractor shall return all special stain slides and PDL1 slides with Pathologist report within 24 hours of picking up the specimen.

Additional Requirements:

1. Global IHC/ISH/Special Stain with Pathologist reporting must offer the following:

a. Semi-quantitative

b. Quantitative

c. Qualitative

d. Infectious Disease

e. Infectious Disease special stain

2. Must have extensive menu for IHC/ISH/Special Stains (Technical only).

3. Certifications, Proficiency and Testing

a. Contractor must have CAP or Joint Commission accreditation

b. Contractor must conduct proficiency testing for PDL1

c. Contractor must utilize QC reports for special stains for review Vendors:

1. Must produce sample QC reports for special stains for review.

2. Must provide evidence of proficiency testing for PDL1.

3. Must provide CAP accreditation certificate.

CPTs Included but not limited to:

1. 88360 Global (FDA antibody clone PD-L1 for Keytruda™, Opdivo™, Tecentric™, etc.)

2. 88341TC (IHC Qualitative, Add’l single antibody stain) Technical

3. 88342TC (IHC Qualitative, Initial single antibody stain) Technical

4. 88344TC (IHC Qualitative, Multiplex antibody stain) Technical

5. 88360TC (IHC Semi-Quant, Single antibody stain) Technical

6. 88361TC (IHC Quantitative, Computer assisted, Single antibody stain) Technical

7. 88364TC (IHC by ISH, Add’l antibody stain) Technical

8. 88365TC (IHC by ISH, Initial antibody stain) Technical

9. 88312TC (Special Tissue Stain)

Specific Requirements:

1. Special Stains, tech only; no Pathologist interpretation needed.

2. Global IHC, with Pathologist interpretation (less than 10% of workload).

3. 24 hour turnaround time for slides and reports. This requires the slides to be at the VA facility within 24 hours and the report available within 24 hours.

4. Vendor is responsible for courier pickup and next day delivery of slides.

5. Computer Assisted Image analysis.

6. Digital pathology slide scan.

7. Online order entry.

8. Extensive IHC menu >250 Antibodies.

9. Provide QC Report for each case submitted.

10. Must provide STAT pickup as needed.

3. Hours of Operation

· Normal tour-of-duty hours at VAGLAHS is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. However, the service is operating 24/7 and as such there may be instances in which the vendor’s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.

· In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”

When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.

4. Travel

· All travel shall be responsibility of the vendor.

· Whenever possible, conference calls and video conferencing should be used.

5. Security

7.1 Information Security

· The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor’s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation.

· The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 “SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES” sited in section C. Contract Clauses

(a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov

(b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov

7.2 Contract Personnel Security

All contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Security and Investigations Center (07C). The level of background security investigation will be in accordance with VA Directive 0710 dated September 10, 2004 and is available at: http://www.va.gov/pubs/asp/edsdirec.asp (VA Handbook 0710, Appendix A, Tables 1 - 3). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award, and are to be completed and returned to the VA Security and Investigations Center (07C) within 30 days for processing. Contractors will be notified by 07C when the BI has been completed and adjudicated. These requirements are applicable to all subcontractor personnel requiring the same access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed, but the contractor will be responsible for the actions of those individuals they provide to perform work for the VA. In the event that damage arises from work performed by contractor personnel, under the auspices of the contract, the contractor will be responsible for resources necessary to remedy the incident.