Ventana IHC and SS SOW FY24.pdf

Naval Medical Center Laboratory Department

San Diego, California 92134

Automated Immunohistochemistry Slide Stainer Automated Special Stainer

STATEMENT OF WORK

1.0 INTRODUCTION

1.1 Organization:

The Naval Medical Center San Diego (NMCSD) and its affiliated Branch Medical Clinics (BMCs) located in San Diego, California are responsible for providing members of the U.S. Armed Forces and their dependents with reliable, high-quality health care. In addition to maintaining premier health care providers military beneficiaries, NMCSD is responsible for supporting the histology workload for NH Camp Pendleton, NH 29 Palms and NH Lemoore.

1.2.1 Background and Objective:

The NMCSD immunohistochemistry (IHC) Laboratory stains over 8000 IHC slides and 1000 Special Stain slides per year. The equipment in place is operated on a cost-per-test basis and is owned by Roche Diagnostics. The Laboratory acquired two new BenchMark Ultra autostainers in 2019, but the autostainers were never fully validated (the Lab has recently completed the validation processes for the 105 stains that are performed by the IHC Lab). The Lab has continued to use the BenchMark Ultra autostainers acquired in 2014 while validating the 2019 BenchMark Ultras. Ventana/Roche has continued to service the older equipment even though they are no longer contractually obligated to do

so. The 2019 BenchMark Ultras are therefore essentially new equipment, having been used solely for the staining of validation slides (approximately 600 total slides per instrument, the equivalent of one month of normal workload).

The Laboratory would like to continue to use the instruments acquired in 2019 under a new contract, as replacing them with new autostainers would require new expensive and time-consuming validation studies and waste the work that is now close to completion.

Adding to the IHC contract will be the introduction of two (2) new Ventana/Roche BenchMark Special Stainers. Once validated, these units will replace the Dako Artisan Special Stainers currently in use. The BenchMark Special Stainers will be housed along side the Ultras and operate using the same computer platform. The computer platform has the capacity to operate up to six (6) individual staining units.

The Dako Artisan Special Stainer contract will not be renewed, resulting in cost savings due to a lower cost per test pricing by Ventana than offered by Dako. Removal of the Dako Artisan Special Stainers frees up valuable bench space in the Histology lab, space that is needed to function in a more efficient, streamlined manner.

2.0 REQUIREMENT

2.1 Task Description and Deliverables:

1) The equipment and reagents shall be in compliance with OSHA requirements.

2) The vendor will remove the current Ventana Benchmark ULTRA Staining Modules

(serial # 312809 and 312765) within 60 days of completion of the validation studies, leaving the two newer staining modules (serial # 317923 and 317952) in place.

3) The vendor will supply, and install, two new BenchMark Special Staining Modules.

4) The vendor will supply all required reagents and special staining kits to begin the validation process.

5) The vendor will retain title to the four automated stainers. At the end of the fourth option year, NMCSD can retain title at no additional charge.

6) In the event of a significant release of new technology, NMCSD can exercise the option to upgrade to the new technology with a pricing to be determined and mutually agreed upon by both parties.

Immunostainer Hardware

1) The equipment must be freestanding.

2) The equipment must have a compact footprint, with two units capable of fitting in a space measuring 72” wide x 46” deep. Must not exceed 68” in height.

3) The equipment must include the operating module.

4) The equipment must be fully automated from dewaxing to counterstaining.

5) Each staining module must have a minimum independent 30 slide capacity and capable of completing up to 90 slides per 8-hour shift per stainer.

6) The equipment must support staining of immunohistochemistry immunofluorescence and in-situ hybridization (ISH) at the same time on the same instrument.

7) The equipment must be “open” with regard to antibody selection and use. That is, antibodies from various manufacturers must be usable in the equipment.

8) The staining unit must perform single, double, triple and immunofluorescent stains in any combination.

9) The equipment must employ some methodology for the minimization of tissue loss.

Special Stainer Hardware

1) The equipment must be freestanding.

2) The equipment must have a compact footprint, with two units capable of fitting in a space measuring 72” wide x 46” deep. Must not exceed 68” in height.

3) The equipment must include the operating module.

4) The equipment must be fully automated from dewaxing to counterstaining.

5) Each staining module must have a 20 slide capacity.

6) The equipment must support special staining routine special stains and silver special stains at the same time on the same instrument.

7) The equipment must employ some methodology for the minimization of tissue loss.

Reagents, consumables

1) Through a cost per test contract, the contractor will provide all reagents and other consumables (with the exception of a small percentage of antibodies, which may be purchased from other sources) necessary for IHC, IF, ISH staining, and Special Staining at NMCSD.

2) A Reagent Usage Agreement (RUA) is the basis by which NMCSD will be required to order a minimum number of detection kits per year. The annual committed volumes to execute this contract is 11,200 slides per year for IHC and 1,500 for Special Stains. This constitutes the floor of the contract.

3) The contractor will provide reagents with an average of 18-24 months shelf-life and a minimum shelf-life (outdate) of no less than 1 year from receipt of antibody at

NMCSD.

4) Vendor capable of supplying a robust profile of antibodies in their catalog that can be ordered under contract.

5) Vendor capable of supplying a robust profile of special stains in their catalog that can be ordered under contract.

6) Vendor must be able to supply FDA-approved antibodies with corresponding companion diagnostics (pharmaceutical) such as Herceptin for HER2-neu.

Other Accessories

1) The contractor will provide the requisite software and peripherals for the use of the operating and staining modules.

Value Added Services

1) The contractor will make a technical support hotline available.

2) The contractor will provide all software upgrades at no charge during the term of the agreement.

3) The contractor will provide all maintenance on-site under the cost per slide agreement so that no maintenance costs will be shifted to the government during the tenure of the contract.

4) No charge for the shipping costs for consumables and reagents as long as the orders do not exceed an average of two shipments per month.

Training and Technical Support

1) The Contractor must act in accordance with commercial practices.

2) The vendor will provide two training slots at no additional charge to the government. The vendor will be responsible for all costs associated with the transportation to and from San Diego to Indianapolis, IN, lodging and meals.

2.2 Task Personnel Requirements

2.2.1 U.S. Citizenship:

U.S. citizenship is required.

2.2.2 Technical and Personal Skills:

All technical staff and service engineers employed by the contractor must have backgrounds in engineering, science, or laboratory technologies. The contractor must provide a rigorous training and credentialing program used to assess competency of and proficiency for those skills necessary to successfully trouble shoot and fix analyzers before being assigned to an account to provide such services.

3.0 Classification - Unclassified

Privacy Act Statement:

“Pursuant to Title 5 United States Code 552a(m)(1), the contractor and all employees of the contractor working under this contract are required to comply with the requirements of 5 U.S.C. 552a (“The Privacy Act of 1974”).

5.0 Travel:

No travel required by NMCSD personnel aside from the off-site training as noted above for the two NMCSD histotechnicians.

6.0 Period of Performance:

Base year with four option years with base year date to begin once contract is awarded.

Proposed base year is 1 July 2024 – 30 June 2025.

7.0 Personal Services

NON PERSONAL SERVICES STATEMENT:

Contractor employees performing services on the stainers under this order will be controlled, directed, and supervised at all times by management personnel of the contractor.

Contractor management will ensure that employees properly comply with the performance work standards outlined in the statement of work. Contractor employees will perform their duties independent of, and without the supervision of, any Government official or other Defense Contractor. The tasks, duties, and responsibilities set forth in the task order may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and

37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

8.0 Invoice Schedule

Contractor may invoice monthly in arrears.

Invoices shall be submitted once a month for services rendered, shipping, during the previous month. No more than one invoice may be submitted per month. Invoices must identify the invoicing period. If charges against more than one line item have occurred during the invoicing period, all charges must be combined into one invoice and correlated with a specific CLIN item listed in the purchase request. Specific invoicing instruction will be provided in the contract award. The contractor’s failure to include the necessary information or a more frequent invoice submission than authorized will result in invoices being rejected. Payment will be processed by Wide Area Work Flow (WAWF).