36C24425Q0288_1.docx

Special Notice

GENERAL INFORMATION

Network Contracting Office 4 Wilmington VA Medical Center 1601 Kirkwood Highway

POINT OF CONTACT*

Contract Specialist Yazmin Alvarez yazmin.alvarez@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

*= Required Field

INTENT TO SOLE SOURCE

In accordance with FAR 6.302-1 Only One Responsible Source and No other Supplies or Services will satisfy agency requirement. The Corporal Michael J. Crescenz VA Medical Center (CMCVAMC) intends to negotiate a Sole Source Award with Roche Diagnostics Corporation. They are located at 9115 Hague Rd, Indianapolis, Indiana 46256-1025. Roche shall provide: all resources necessary to accomplish the deliverables described in this Performance Work Statement (PWS). The contractor shall be responsible for the following:

This scope requires the contractor to furnish the (CMCVAMC), with FDA approved for clinical use laboratory instrument(s) system(s), UPS(s), services, maintenance, consumables, reagents, for the completion of in house testing for HPV Genotype, HCV Viral Loads, HBV Viral Loads, and HIV Viral Loads testing on one testing platform for the life of the contract on a fully automated amplification and detection for polymerase chain reaction (PCR) testing platform, with sample in and results out capability. All things necessary to operate the contractor’s equipment, hardware and software upgrades, training for personnel and equipment maintenance necessary to fulfill the test requirements.

a. Task One: HPV Genotype, testing instrument and Reagents:

• The contractor shall provide general instrument with characteristics including being able to run HPV Genotyping based assays on one RT-PCR technology-based platform in batch sizes of 24 or 96 or random access, that can run in less than one hour. The system must identify least the listed variants HPV 16 and HPV 18 while concurrently detecting the rest of the high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The instruments provided must be able to purify DNA, RNA, and viral nucleic acids from a wide range of starting materials using magnetic glass particle technology with test-specific reagents. Bar-coded data entry capabilities that allow B-directional interface for host connection to connect to LIS. To provide accurate, dependable regulatory compliant, reproducible, actionable patient results that can transfer to the patient electronic medical record in an our or less. Reagents should be ready to use, consolidated to include analyte and contamination controls to reduce reagent storage needs. On a platform that is the newest and most reliable with no daily maintenance required and minimal pre and post analytic sample preparation steps required with confined extraction processing. The sample results must be reported in the industry standard units, with sensitivity ranges that allow for inclusion of the entire clinically significant range for identification.

Deliverable 1: Instrument and Consumables

b. Task Two: HCV Viral Loads, HIV Viral Loads, and HBV Viral Loads

• The contractor is required to furnish Philadelphia VAMC laboratory instrument(s) system(s), reagents, and UPS(s) to include detection kits for HCV Viral Loads, HIV Viral Loads, and HBV Viral Loads for the life of the contract. The detection kits will be determined by user based on tests performing fully automated, on a continuous load IVD platform featuring sample in and results out capability necessary to operate the contractor’s equipment, hardware and software upgrades, training for personnel and equipment maintenance necessary to fulfill the test requirements. Bar-coded data entry capabilities that allow B-directional interface for host connection to connect to LIS. To provide accurate, dependable regulatory compliant, reproducible, actionable patient results that can transfer to the patient electronic medical record in an hour or less. Reagents should be ready to use, and consolidated to include analyte and contamination controls to reduce reagent storage needs. On a platform that is the newest and most reliable with less than 15 minutes of daily maintenance required and minimal pre and post analytic sample preparation steps required with confined extraction processing. The sample results must be reported in the industry standard units, with sensitivity ranges that allow for inclusion of the entire clinically significant range for identification.

Deliverable 2: Instrument and consumables

c. Task Three: Functionality and Performance Specifications:

• AmpErase incorporated in every reaction to prevent against carry-over amplicon

• Real-time PCR detection, up to 3 assays at a time

• Offers HIV primers and probes that are used to amplify the gag and LTR regions

• A novel dual-probe approach for HCV viral load test

• In vitro nucleic acid amplification test for the quantitation of hepatitis C virus RNA genotypes 1 to 6 in human EDTA plasma or serum.

• Dual-target HIV testing design.

• Able to quantify HIV-1 RNA from 20 - 10,000,000 copies/mL

• Able to quantify HCV RNA from 15 – 1×108 IU/mL

• Detects HBV genotypes A-H and pre-core mutants.

• Able to reuse reagents to avoid reagent waste.

• An Internal Control/Quantitation Standard (IC/QS) incorporated into each individual sample and is carried through the sample preparation.

• Controls are included as part of the kit, not separately.

• FDA approved for parallel processing capabilities, with the ability to run multiple assays in parallel.

• Overnight operation capabilities.

• Instrument reagents are ready-to-use pre-packaged, bar-coded cassettes.

• Confined extraction processing to reduce aerosolization.

• Power characteristics 100 to 125 and 200 to 240 VAC

• B-directional interface for host connection to connect to LIS, sending results to the LIS

• Computer system (CPU, Monitor, Keyboard, Printer,), UPS for all instruments for the life of the instruments.

• The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste.

• The system should not require monitoring during a run and should be 100% “walk-away” system.

d. Task Four - TRAINING OF OPERATING PERSONNEL:

The contractor shall provide the services of a qualified technical person, at the time of new equipment installation and at such time designated by Contracting Officer (CO) or Contracting Officer's Representative (COR) to on-site orientation and training to designated personnel in: (1) operation and care of equipment; 2 techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under contract guarantee clause.

Deliverable 3: On-site training to staff for instrument all instrument user requirements.

e. Task Five-Installation procedures:

The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the installation may be suspended until such time as the cause of delay has been eliminated.

Deliverable 4: Completely installed instrument validated and ready for patient testing.

f. Task six: Maintenance and Service:

The contractor shall provide maintenance (labor and parts) to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services. Preventive maintenance by contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment. Repairs shall be performed within 24 hours after notification that the equipment is inoperative. The scheduled maintenance and service shall be performed by a qualified engineer with notice to the Contracting Officer Representative (COR). CMC VAMC, PHILADELPHIA normal business hours are 6:00 am - 6:00 p.m., excluding weekends and holidays. Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification. The contractor will provide all parts and labor needed to repair the malfunction. The travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the Government during this period.

The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

The NAICS code for this procurement is 325413. The size standard is 1,000 employees.

Interested parties that can meet the capabilities and requirements, may identify their interest and submit quotations. This notice of intent is not a request for quotations. Interested parties who believe they can meet the requirements, must submit information about their capabilities no later than NOON EST, 02/13/2025. All information shall be provided at no cost, or obligation to the Government.

No solicitation will be made available. Information must be sent to the Contract Specialist, yazmin.alvarez@va.gov. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely at the discretion of the Government. If no responses are received, the Contracting Department will proceed with the sole source negotiation with Roche.

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