P09 RENAL TRANSPLANT and ROUTINE BIOPSY PROCESSING SOW.pdf

STATEMENT OF WORK

Title of Project: Renal Transplant and Routine Biopsy Processing

Background: James J. Peters VA Medical Center requires Renal Transplant Services and Routine Renal Tissue Biopsies processing for special stains, Immunohistochemistry (IHC), Electron Microscopy (EM), and analysis and diagnosis by a Renal Pathologist. This service is required for routine and transplant patients’ management. The pathology is to be performed on Renal Tissue Biopsies Pre- and Post- Transplant.

Scope of Work:

The Contractor must provide the services required under this Statement of Work on the day/time the Renal Biopsy Tissue is received. The annual number of Renal Biopsies is estimated on previous years. The estimated annual number of renal biopsies to be sent for processing and analysis is 50.

The fresh Renal Tissue obtained surgically from a routine procedure or Renal Transplant recipient, must be picked up at the JJP VAMC by the courier service.

The Renal Biopsy Tissue from routine or transplant recipient must be processed, and slides must be made and stained for Light Microscopy, Immunohistochemistry, and Electron Microscopy. When renal tissue is received before 12:00 PM, the Contractor must provide a preliminary analysis (report) on the same day, no later than 6:00 PM that day.

Renal tissue received on Saturday, or after hours (emergency), the Contractor must provide a preliminary analysis (report) as soon as possible, but no later than the following day.

Period of Performance: performance shall be for Base plus four years.

BASE YEAR: 9/1/ 2025 - 8/31/2026

Line Item

Description/Part Number Qty Unit Price

Amount

1 Gross & Micro Exam Report (CPT 88305) 23 $91.00 $2,093.00 2 Special Stains (x 4 units for adult cases) (CPT 88313) - 3 Parts 23 $199.50 $4,588.50 3 Immunofluorescence Initial stain (CPT 88346) 23 $105.00 $2,415.00 4 Immunofluorescence each additional (CPT 88350) - 7 Parts 23 $759.50 $17,468.50 5 Electron Microscopy (CPT 88348) 23 $486.50 $11,189.50

Total $37,754.50

OPTION ONE: 9/1/ 2026 - 8/31/2027

Line Item

Description/Part Number Qty Unit Price

Amount

1 Gross & Micro Exam Report (CPT 88305) 23 $91.00 $2,093.00 2 Special Stains (x 4 units for adult cases) (CPT 88313) - 3 Parts 23 $199.50 $4,588.50 3 Immunofluorescence Initial stain (CPT 88346) 23 $105.00 $2,415.00 4 Immunofluorescence each additional (CPT 88350) - 7 Parts 23 $759.50 $17,468.50 5 Electron Microscopy (CPT 88348) 23 $486.50 $11,189.50

Total $37,754.50

OPTION TWO: 9/1/2027 – 8/31/2028

Line Item

Description/Part Number Qty Unit Price

Amount

1 Gross & Micro Exam Report (CPT 88305) 23 $91.00 $2,093.00 2 Special Stains (x 4 units for adult cases) (CPT 88313) - 3 Parts 23 $199.50 $4,588.50 3 Immunofluorescence Initial stain (CPT 88346) 23 $105.00 $2,415.00 4 Immunofluorescence each additional (CPT 88350) - 7 Parts 23 $759.50 $17,468.50 5 Electron Microscopy (CPT 88348) 23 $486.50 $11,189.50

Total $37,754.50

OPTION THREE: 9/1/2028 – 8/31/2029

Line Item

Description/Part Number Qty Unit Price

Amount

1 Gross & Micro Exam Report (CPT 88305) 23 $91.00 $2,093.00 2 Special Stains (x 4 units for adult cases) (CPT 88313) - 3 Parts 23 $199.50 $4,588.50 3 Immunofluorescence Initial stain (CPT 88346) 23 $105.00 $2,415.00 4 Immunofluorescence each additional (CPT 88350) - 7 Parts 23 $759.50 $17,468.50 5 Electron Microscopy (CPT 88348) 23 $486.50 $11,189.50

Total $37,754.50

OPTION FOUR: 9/1/2029 -8/31/2030

Line Item

Description/Part Number Qty Unit Price

Amount

1 Gross & Micro Exam Report (CPT 88305) 23 $91.00 $2,093.00 2 Special Stains (x 4 units for adult cases) (CPT 88313) - 3 Parts 23 $199.50 $4,588.50 3 Immunofluorescence Initial stain (CPT 88346) 23 $105.00 $2,415.00 4 Immunofluorescence each additional (CPT 88350) - 7 Parts 23 $759.50 $17,468.50 5 Electron Microscopy (CPT 88348) 23 $486.50 $11,189.50

Total $37,754.50

Type of Contract: Firm Fixed Price

Place of Delivery:

James J. Peters VA Medical Center 130 West Kingsbridge Road Bronx, NY 10468 Pathology Laboratory, Histology 2B-37

Place of Performance:

Designated pick up locations are:

a) Histology Laboratory, room 2B-37-100, Monday- Friday, 8:00 AM to 4:30 PM.

b) Specimens obtained Monday-Friday after 4:30 PM and on Saturdays will be picked up in the Core Laboratory, room 2B-15-100.

Other Related Services (Not Included in the Scope of Work):

Any services not expressly stated in this Statement of Work are not authorized. No person, including the COR or any other VA personnel may request additional work be performed by the

Contractor, except for the Contracting Officer. Any added services performed that are not authorized by the Contracting Officer will be considered inclusive.

Contract language to include:

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

1. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

2. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

3. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

4. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

2. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

c. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

d. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

a. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

b. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

3. TRAINING

c. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training.

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

d. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

e. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.