6632--Automated Cytology CPT

Statement of Need (SOW)

To procure an automated cytology processing system, reagents, and supplies for the James A. Haley Veterans' Hospital, Department of Pathology and Laboratory Medicine Service. The system must be FDA-approved and capable of processing cellular material using liquid-based technology for cytological examination.

• Provide automated cytology processing systems (Hologic® ThinPrep 5000 Processor and Hologic® ThinPrep Genesis with slide printer).

• Supply all necessary reagents and consumables for system operation, including calibration, linearity testing, controls, disposables, and instrument parts.

• Offer on- and/or off-site training for end-users and key operators.

• Provide delivery and installation of equipment at no additional charge.

• Perform system installation, maintenance coordination, and supply procurement.

• Estimated annual sample processing volume: 2,000 GYN (ThinPrep Pap Tests) and 7,000 ThinPrep Non-Gynecological specimens.

• Reagent quality must meet proficiency testing standards of the College of American Pathologists and The Joint Commission.

• Contractor must provide technical assistance for correlation studies at no additional cost.

• Equipment must be new and meet specified technical requirements (dimensions, capacity, automation features).

• Preventative maintenance must be performed according to manufacturer's instructions and completed within 2 weeks of the due date.

• Response time for technical support: within 3 days for on-site, 24 hours for telephone.

• Equipment downtime: 10% or more of normal working days in a calendar month may result in a request for replacement.

• Prolonged downtime (48 consecutive hours or more) may result in assessed damages.

• Place of performance: James A. Haley Veterans' Hospital, Tampa, Florida.

• Period of performance: Not explicitly stated in this document, but implies ongoing supply and service.

• All equipment provided must be new.

• System shall NOT interface with the VA network.

• Contractor must provide technical procedures in CLSI format on diskette.

• All shipping costs for reagents, consumables, supplies, and equipment are the contractor's responsibility.

• Emergency supply delivery required within 24 hours for defective or unsuitable supplies.

• Contractor is responsible for all inspections and tests to substantiate contract conformity.

• Contractor must comply with all applicable records management laws and regulations, including NARA and Privacy Act.

• Contractor personnel require background investigations and must comply with VA information security and privacy language.

Solicitation / RFP / RFQ

This document is a solicitation for Automated Cytology CPT (Cytology Preparative Technology) equipment. The Department of Veterans Affairs (VA), Network Contracting Office 8 (NCO 8), is seeking to procure this equipment.

• The primary deliverable is Automated Cytology CPT equipment.

• Specific details regarding technical requirements or performance standards are not fully detailed in this excerpt but are likely contained within the attached "D.1 Statement of Need" document.

• The solicitation number is 36C248-26-AP-3075.

• The Product Service Code (PSC) is 6632.

• The North American Industry Classification System (NAICS) Code is 334516.

• Specific submission instructions and evaluation criteria are not detailed in this excerpt. Potential bidders should refer to the full solicitation package.

• The "BASE NOTICE TYPE" is listed as "ARCHIVE", and "RECOVERY ACT FUNDS" is marked as "N". No specific set-aside information is provided in this excerpt.

• This opportunity references two attached documents: "D.1 Statement of Need" and "P03 Single Source Justification MPT to SAT_Redacted". Bidders should consult these attachments for comprehensive details.

• The contracting office is located at 8875 Hidden River Pkwy Ste 160A, Tampa, FL 33637.

• The Point of Contact is David Griganavicius, Contract Specialist, at david.griganavicius@va.gov or 813-796-2945.

Other / Unclassified

This document is a "Single Source Justification" for the Department of Veterans Affairs, James A. Haley Veterans' Hospital. It justifies the procurement of the ThinPrep T5000 Processor, an automated slide preparation system, on a sole-source basis.

This document is relevant to potential bidders as it explains why a specific piece of medical equipment (ThinPrep T5000 Processor) is being procured through a single source. It highlights:

• Urgent and Compelling Need: An emergency situation arose due to the departure of the assigned Contracting Officer, creating an immediate need for support and preventing a longer-term solution.
• Impact on Operations: The ThinPrep systems are described as the only conventional method for Pap smear preparation, essential for detecting cervical cancer and other cytologic diagnoses. Failure to procure this system expeditiously poses an unacceptable risk to patient life, health, and safety, directly impacting patient care, diagnosis, and treatment.
• Sole Source Rationale: Hologic is identified as the sole proprietary manufacturer and domestic distributor of the ThinPrep systems. Market research on SAM.gov indicated the requirement is sole-sourced to Hologic.
• Procurement Details: The Contracting Activity is VISN 8, NCO 08, James A. Haley Veterans' Hospital. The justification is made in accordance with RFO FAR 12.102(a).