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6515--Notice of Intent to Sole Source - ThinPrep 2000 Processor

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36C24921Q0578Federal

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The Department of Veterans Affairs, through Network Contracting Office 9, intends to award a sole source contract to Hologic, Inc. for the procurement of the ThinPrep 2000 system, a specialized automated slide preparation device used in cervical cancer screening and cytology testing. This equipment replaces traditional Pap smear methods, producing thin, uniform cell samples on microscope slides for pathologist review. The ThinPrep 2000 is unique in that it processes FDA-approved tests for both Pap and HPV from a single vial and creates slides that are read in one direction, enhancing diagnostic accuracy. It operates via mechanical, pneumatic, and fluidic systems carefully controlled by microprocessors to ensure consistent sample preparation. The system boasts a throughput of about 25 samples per hour, with the capacity to handle up to 50,000 samples annually within a typical work shift. The contract, expected to be awarded around September 10, 2021, falls under NAICS code 325413, with a small business size standard of 1,000 employees. Although this notice signals intent to award without competitive bidding, other suppliers may submit capability statements by September 3, 2021, to propose brand name or equivalent products that meet the stringent requirements, including OEM warranty and service provisions. Any non-manufacturer suppliers must provide OEM authorization to ensure compliance with warranty and maintenance standards. All software, warranty, and maintenance services will be rooted in the original equipment manufacturer's terms and the use of OEM-certified technicians and approved parts. Submissions are to be made electronically to the Contracting Officer, Stephen A. Clabough, for consideration, though the government retains sole discretion in awarding the contract.

General Info

VA plans sole source contract to Hologic for ThinPrep 2000 cervical cancer screening system.

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

TN

Set-Aside

NONE

Documents

2

Notice of Intent to Sole Source - ThinPrep 2000 Processor - 36C24921Q0578

DOCX, Low priorityspecial-notice
Low

Notice of Intent to Sole Source - ThinPrep 2000 Processor 36C24921Q0578

DOCX, Low prioritypresolicitation
Low

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 249-NETWORK Contract Office 9 (36C249)
Contacts1 person available
OfficeMURFREESBORO, TN, 37129, USA
Office AddressMURFREESBORO, TN, 37129, USA
Contacts
Stephen A. ClaboughContracting Officer

Full Description

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UNITED STATES DEPARTMENT OF VETERANS AFFAIRS NETWORK CONTRACTING OFFICE 9 NOTICE OF INTENT TO SOLE SOURCE - In accordance with Federal Acquisition Regulation (FAR) 13.106-1(b)(1)(i) and on behalf of the Louisville VA Medical Center, Network Contracting Office (NCO) 9 intends to negotiate on a sole source basis with Hologic, Inc., located at 250 Campus Drive, Marlborough, MA 01752-3020, for the provision of a Thin Prep 200 system. The rationale basis for the sole source acquisition is that Hologic, Inc. is the only responsible source that can provide a ThinPrep® 2000. This processor is for the replacement of a 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 and thinprep slide preparation for non-gyn body fluid specimens. The samples are collected, processed, transferred, and fixed onto microscope slides in preparation for staining, cover slipping and screening. The processor produces thin, uniform preparations of cells on ThinPrep microscope slides. These slides are read by pathologists for examination and cancer diagnosis. The ThinPrep® 2000 is: An automated slide preparation unit/processor that can process FDA-approved tests for both Pap and HPV testing from a singular vial; and A processor that makes slides that require to be read in one direction rather than the slide being screened once horizontally and second time vertically. In addition to the numbered characteristics above, the salient characteristics of this requirement are as follows: Utilizes mechanical, pneumatic and fluidic principles for cell dispersion, collection and transfer. Dispersion: A rotary drive mechanism gently disperses samples. Collection: A pneumatic/fluid system, controlled by a microprocessor, monitors cell collection. Transfer: Computer-controlled position and positive air pressure facilitate transfer of cells to the ThinPrep microscope slide. Instrument dimensions: Width 46 cm/18" Height 50 cm/19.5" Depth 38 cm/15 Throughput: Approximately 25 samples per hour. Up to 50,000 samples per year within a single 8-hour shift. Weight: 19 kg/41 lb (approx.) Waste container: Width 15 cm/6 Height 43 cm/17 Depth 15 cm/6 Operating temperature: 15-32°C / 59-90°F Operating humidity: 20% - 90% RH non-condensing Electrical Voltage: 100/120 VAC at 2 amps 220/240 VAC at 1 amp Frequency: 47-63 Hz Power maximum: 200 watts This acquisition is anticipated to take place on or about September 10, 2021. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112 with a small business size standard of 1000 employees. This notice of intent is not a request for offers. However, all responsible sources may submit a capabilities statement stating how the source can provide a brand name or equal product with the needed warranty while considering the Non-Manufacturer Rule, Buy American Act, and Trade Agreements Act. If the interested source is not the Original Equipment Manufacturer (OEM) of the proposed equipment, said source must submit with the capability statement a letter from the manufacture stating that the interested source is an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM s terms and conditions. The maintenance shall be provided by original equipment manufacturer (OEM)-certified technicians and shall use only OEM-approved replacement parts and proprietary software, as applicable All capability statements received by the closing date of this synopsis will be considered by the government. A determination by the government not to compete based on responses to this notice is solely within the discretion of the government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Stephen A. Clabough at stephen.clabough@va.gov. Capability statements are due not later than 1200 CT on 03 September 2021. No phone calls will be accepted. Government Point of Contact: Stephen A. Clabough Contracting Officer Stephen.Clabough@va.gov

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