SPECIAL NOTICE
66 -- NOTICE OF INTENT TO SOLE SOURCE ThinPrep T5000 Processor (New)
- Notice Date
- 5/29/2021 8:36:03 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 248-NETWORK CONTRACT OFFICE 8 (36C248) TAMPA FL 33637 USA
- ZIP Code
- 33637
- Solicitation Number
- 36C24821Q0830
- Archive Date
- 06/28/2021
- Point of Contact
- Janice Fornaro, Contracting Officer, Phone: 727-398-9335
- E-Mail Address
-
janice.fornaro@va.gov
(janice.fornaro@va.gov)
- Awardee
- null
- Description
- Special Notice - Notice of Intent to Award a Sole Source Procurement The Department of Veterans Affairs, Veterans Health Administration, Veterans Integrated Service Network (VISN) 8, Network Contracting Office 8, intends to award a firm-fixed price purchase order to Hologic, Inc., 35 Crosby Drive, Bedford, MA 01730 for procurement of the following: One (1) ThinPrep T5000 Processor. ThinPrep® T5000 Processor - Is the only conventional method of Pap smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions (Low-grade Squamous Intraepithelial Lesions, High-grade Squamous Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses. No other automated processor can meet the level of quality and throughput as the ThinPrep® T5000 processor. Salient Characteristics Hologic ThinPrep 5000 Processor for Gynecologic, Non-gynecologic, and Urine Specimen Equipment: Hologic ThinPrep 5000 Processor (Part# 71362-001) GENERAL REQUIREMENTS: The ThinPrep 5000 Processor (or equal) must Include the following Components and Features: Shall be a fully automated slide preparation, including automated capping and de-capping of machines/equipment vials, chain of custody verification and slides directly output into stainer-ready racks Shall be a benchtop unit with Built-in touchscreen. Must have an input carousel for up to 20 samples per batch. Must include waste bottle Must include fixative bath with staining rack Must include filter waste bin Must be able to check vial and slide Identification (ID) Must be able to pick up the vial and filter Must be able to deposit slides into the fixative bath The processor must support the preparation of: Gynecologic specimens for use with the equipment s Pap test, and subsequent imaging by the equipment s Imaging System, or samples for gynecologic cytology screening. Must be able to collect non-gynecologic specimens for general cytologic screening. Must have urine specimens used in conjunction with the equipment s Urine Collection Kit. The dimensions must not exceed: Height 40 inches Width 40 inches Depth 36 inches Operating Temperature / Humidity must be: 16-32° C or 60-90° F 20% 80% RH, non-condensing Must have power requirements 100-130 VAC at 50-60 Hz, 240 Watts Installation: The vendor must provide installation support for the completion of all required validation documents / correlation studies CAP guidelines. The Vendor must provide Standard Operating Procedures (SOP s) for the instrument operation, quality control, and maintenance. The Vendor must provide Safety Data Sheets (SDS) for all reagents, supplies, and consumables associated with the instrument operation. Training: The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, and sufficient to the size and scope of the facility s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Shall include the cost of the training program in the installation cost. For off-site key operatory training (2 operators), the vendor must agree to pay all associated costs to attend the training (flight, baggage, lodging, meals, and transportation). Upgrades: During the life cycle of the equipment, the Contractor shall provide to the Government all hardware and software upgrades i.e. new version of software, correction of hardware defect, etc., that are customarily provided to equivalent commercial customers at no cost to the Government. Ancillary support equipment: The Contractor shall provide to the Government all ancillary components that are customarily provided to equivalent commercial customers with the model of equipment offered, including but not limited to, starter kits, LIS interface, automation track line connectivity. Commercial Offerings: The Contractor shall provide the Government laboratories any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. template for writing standard operating procedures (SOPs), PC of their procedure / user manuals, an on-line procedure manual in the instrument software, training documents, competency sheets, validation protocols including documentation of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), test case scenarios and any other material necessary to comply with current Good Manufacturing Practice (cGMP) standards, etc. Characterization of hazardous waste: The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et al. The description shall address the following: Waste toxicity (Reference 40CFR261.11 and 40CFR261.24) Waste ignitability (Reference 40CFR261.21) Waste corrosivity (Reference 40CFR261.22) Waste reactivity (Reference 40CFR261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40CFR261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40CFR261.33) Implementation/transition timeframe: The transition period for the awarded Contractor to have all instrumentation installed and operational is 90 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. It is preferred that at least 1 key operator attends training prior to the installation of the equipment. Service: 1-year manufacturer included + 4yr extended service DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C248-21-AP-2903 Contracting Activity: Department of Veterans Affairs, VISN 8, C.W. Bill Young VA Medical Center Medical Center. Purchase request #516-21-2-213-0167. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: ThinPrep T5000 Processor, fully automated slide preparation, including automated capping and de-capping of ThinPrep vials, chain of custody verification and slides directly output into stainer-ready racks. The estimated amount of the processor is $90,250.00. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Hologic, Inc., a large business, is the manufacturer of the ThinPrep® T5000 processor and it is the only conventional method of Pap smear preparation for use in screening for the presence of atypical cells, cervical cancer, or its precursor lesions (Low-grade Squamous Intraepithelial Lesions, High-grade Squamous Intraepithelial Lesions), as well as all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses. No other automated processor can meet the level of quality and throughput as the ThinPrep® T5000 processor. Due to the training aspect included with the purchase, Hologic is obligated to provide the training under their FDA approval and cannot utilize any distributors for their diagnostic products. All interactions and training will be performed by certified Hologic employees. Hologic currently does cytology business with over 80 VAMCs primarily through open market contracts. Description of market research conducted and results or statement why it was not conducted: Market Research conducted via catalog, internet, VIP (veteran information pages). Further market research revealed that other VA s have recently issued an Intent to Sole Source or sole sourced this T5000 Processor on beta.SAM.gov. West Haven, CT issued their Intent to Sole Source, for the T5000 Processor, 36C241-689-21-1-782-10034, on 02/26/2021 03/03/2021 and received no responses. A sole source award was recently made on 04/26/2021, 36C248621P0873, by the Hampton VA for the T5000 Processor. A sole source awarded, by VISN-7, Augusta, GA on 02/23/2021, 36C24721P0425 for the T5000 Processor. A Sources Sought notice was issued by C.W. Bill Young on beta.SAM.gov, 36C24821Q0930, unrestricted, on 05/07/2021 and closed on 05/14/2021, no responses were received except from Hologic, Inc. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ Name: Janice Fornaro Date: 05/19/2021 Title: Contracting Officer
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-
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- Record
- SN06016877-F 20210531/210529230101 (samdaily.us)
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