6632--Polymedco OC Auto Sensor

Description

{"description":"Notice of Intent to Award Sole Source\n\nPLEASE READ THIS NOTICE CAREFULLY AS IT CONSTITUTES THE ONLY NOTICE THAT WILL BE PUBLISHED.\n\n\nThe Network Contracting Office (NCO) 16, located at Galleria Financial Center, 5075 Westheimer Rd., Suite 750, Houston, Texas 77056, in support of Central Veterans Healthcare System (CAVHS), intends to solicit and award a Sole Source, Firm-Fixed-Price, contract to one (1) large business source, Polymedco.\n\nPolymedco\n510 Furnace Dock Road\nCortlandt Manor, New York 10567\n\nCAVHS needs one (1) OC-SENSOR DIANA FOBT Analyzer. Currently in use is the Polymedco OC-Auto Micro 80 analyzer to perform fecal immunochemical testing (FIT) for the detection of fecal occult blood in Veterans. Polymedco is sunsetting the OC-Auto Micro 80 platform and associated service/support, necessitating transition to the OC-Auto Sensor Diana analyzer while maintaining compatibility with existing FIT collection vials.\n\nEquipment Specifications:\nGeneral analytical requirements:\nMust be a moderate-complexity FIT method for fecal occult blood testing.\nMust be fully automated and support continuous loading of samples during operation.\nMust support use of closed sampling bottles and Polymedco FIT collection vials.\nThroughput and capacity:\nMust have a throughput of approximately 280 tests per hour to support high-volume screening workloads.\nMust accommodate at least 150 samples on board (e.g., 15 racks of 10 samples each) or equivalent sample capacity.\nPhysical and environmental requirements:\nMust fit within an allocated bench space not to exceed approximately 30in x 30in x 30in; configuration and placement must be suitable for Room 2D159 at CAVHS.\nApproximate instrument dimensions of about 630mm x 630mm x 560mm (22in x 24.8in x 22in) and maximum net weight of roughly 133lb are acceptable or better, provided the unit fits in the defined space and meets site requirements.\nPower requirements shall be approximately 100-240V, 50/60Hz, 500VA, suitable for standard medical laboratory power outlets.\nAnalytical method and optical system:\nMust use latex agglutination immune-turbidimetry (or equivalent latex-based turbidimetric technology) for the detection of human hemoglobin in stool samples.\nLight source should be an LED with wavelength near 600nm or manufacturer-specified equivalent, with thermostatic reaction block (approximately 37 ) and suitable reagent block temperature control.\nData management and interfaces:\nMust provide integrated bar-code reading for sample and reagent identification to reduce transcription errors and support automated result reporting.\nMust be able to interface with VistA or Cerner (or the current VA enterprise Laboratory Information System (LIS) in use at CAVHS at the time of implementation) using appropriate communication protocols.\nMust be compatible with Data Innovations middleware or other VA-approved middleware solutions used by CAVHS for result routing and rules-based processing.\nMust provide onboard data management, including storage of at least 100,000 patient results or equivalent, and the capability to produce Levy-Jennings control charts for quality control monitoring.\nCalibration and quality control:\nCalibration must be straightforward to perform and stable over a manufacturer-recommended interval, minimizing frequency of recalibration while maintaining accuracy.\nCalibrators must be traceable to a recognized national standards organization as required by Clinical and Laboratory Standards Institute (CLSI) and/or the College of American Pathologists (CAP).\nThe instrument must support multi-level quality control materials, statistical QC monitoring and programmable QC rules suitable for CAP-accredited laboratories.\nUser interface and automation features:\nMust provide a touch-screen graphical user interface with a color display for operation and monitoring.\nMust include automatic start, automatic wash, and automatic shutdown functions to support standardized daily workflows and maintenance.\nMust support STAT sample handling or STAT mode to prioritize urgent samples.\nRegulatory compliance:\nThe analyzer and test system must be FDA-cleared for the intended use of occult blood testing and comply with applicable 21 CFR regulations.\nThe device must meet VA and local CAVHS policies for medical device connectivity, electrical safety, and cybersecurity.\n\nThe North American Industry Classification (NAICS) code for this acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The size standard is 1,000 employees.\n\nThis procurement is being conducted under Revolutionary FAR Overhaul (RFO) Federal Acquisition Regulation (FAR) Parts 12.102(a) Restricting Competition and FAR 5.101 Presolicitation Notice. This notice is not a request for quotes, but rather a notice of intent to sole source.\n\nThe anticipated award date is 26 March 2026. The Government intends to award a Firm-Fixed-Price contract.\n\nPlease note that this is not a request for competitive quotes and is being posted for information purposes only. The Government does not anticipate receiving responses to this notice. However, interested parties who disagree with this action may submit a letter of interest that demonstrates their firm s technical expertise, an original equipment manufacturer (OEM) authorization letter to sell/distribute OEM products. Interested vendors shall communicate how their product is compatible with existing fecal immunochemical testing (FIT) collection vials and VISN-wide standardization initiatives. Interested vendors shall communicate if their product is domestic or non-domestic. The Government reserves the right to verify any request for additional documentation submitted.\n\nInterested parties shall identify their interests, provide OEM authorization, personnel certifications/training as mentioned in Section V of this document, and demonstrate their capabilities to meet the Government s requirements. They must respond to this notice within fifteen (15) calendar days of the publication of this notice. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government.\n\nInterested parties may identify their interest solely via email to Contract Specialist, Carmyn E. Williams at Carmyn.Williams@va.gov no later than Monday, 09 March 2026 at 10:00 AM Central Standard Time (CST). When responding to this announcement, respondents should include 36C25626Q0383 Notice of Intent in the subject line.\n\nLate responses may not be accepted. No telephone inquiries will be accepted, nor will phone calls be returned. Only emailed responses will be considered. Information received will be used solely for determining whether to conduct competitive procurement. A determination not to compete with this proposed acquisition based upon response to this notice is at the sole discretion of the Government.\n"} Solicitation Number: 36C25626Q0383 Type: Presolicitation Base Type: Presolicitation NAICS: 334516 Classification Code: 6632 Response Deadline: 2026-03-09T10:00:00-05:00 Office Address: RIDGELAND, MS Place of Performance: North Little Rock, AR, 72114 POC: Carmyn E Williams, Carmyn.Williams@va.gov, 713-799-0795 {"description":"Notice of Intent to Award Sole Source\n\nPLEASE READ THIS NOTICE CAREFULLY AS IT CONSTITUTES THE ONLY NOTICE THAT WILL BE PUBLISHED.\n\n\nThe Network Contracting Office (NCO) 16, located at Galleria Financial Center, 5075 Westheimer Rd., Suite 750, Houston, Texas 77056, in support of Central Veterans Healthcare System (CAVHS), intends to solicit and award a Sole Source, Firm-Fixed-Price, contract to one (1) large business source, Polymedco.\n\nPolymedco\n510 Furnace Dock Road\nCortlandt Manor, New York 10567\n\nCAVHS needs one (1) OC-SENSOR DIANA FOBT Analyzer. Currently in use is the Polymedco OC-Auto Micro 80 analyzer to perform fecal immunochemical testing (FIT) for the detection of fecal occult blood in Veterans. Polymedco is sunsetting the OC-Auto Micro 80 platform and associated service/support, necessitating transition to the OC-Auto Sensor Diana analyzer while maintaining compatibility with existing FIT collection vials.\n\nEquipment Specifications:\nGeneral analytical requirements:\nMust be a moderate-complexity FIT method for fecal occult blood testing.\nMust be fully automated and support continuous loading of samples during operation.\nMust support use of closed sampling bottles and Polymedco FIT collection vials.\nThroughput and capacity:\nMust have a throughput of approximately 280 tests per hour to support high-volume screening workloads.\nMust accommodate at least 150 samples on board (e.g., 15 racks of 10 samples each) or equivalent sample capacity.\nPhysical and environmental requirements:\nMust fit within an allocated bench space not to exceed approximately 30in x 30in x 30in; configuration and placement must be suitable for Room 2D159 at CAVHS.\nApproximate instrument dimensions of about 630mm x 630mm x 560mm (22in x 24.8in x 22in) and maximum net weight of roughly 133lb are acceptable or better, provided the unit fits in the defined space and meets site requirements.\nPower requirements shall be approximately 100-240V, 50/60Hz, 500VA, suitable for standard medical laboratory power outlets.\nAnalytical method and optical system:\nMust use latex agglutination immune-turbidimetry (or equivalent latex-based turbidimetric technology) for the detection of human hemoglobin in stool samples.\nLight source should be an LED with wavelength near 600nm or manufacturer-specified equivalent, with thermostatic reaction block (approximately 37 ) and suitable reagent block temperature control.\nData management and interfaces:\nMust provide integrated bar-code reading for sample and reagent identification to reduce transcription errors and support automated result reporting.\nMust be able to interface with VistA or Cerner (or the current VA enterprise Laboratory Information System (LIS) in use at CAVHS at the time of implementation) using appropriate communication protocols.\nMust be compatible with Data Innovations middleware or other VA-approved middleware solutions used by CAVHS for result routing and rules-based processing.\nMust provide onboard data management, including storage of at least 100,000 patient results or equivalent, and the capability to produce Levy-Jennings control charts for quality control monitoring.\nCalibration and quality control:\nCalibration must be straightforward to perform and stable over a manufacturer-recommended interval, minimizing frequency of recalibration while maintaining accuracy.\nCalibrators must be traceable to a recognized national standards organization as required by Clinical and Laboratory Standards Institute (CLSI) and/or the College of American Pathologists (CAP).\nThe instrument must support multi-level quality control materials, statistical QC monitoring and programmable QC rules suitable for CAP-accredited laboratories.\nUser interface and automation features:\nMust provide a touch-screen graphical user interface with a color display for operation and monitoring.\nMust include automatic start, automatic wash, and automatic shutdown functions to support standardized daily workflows and maintenance.\nMust support STAT sample handling or STAT mode to prioritize urgent samples.\nRegulatory compliance:\nThe analyzer and test system must be FDA-cleared for the intended use of occult blood testing and comply with applicable 21 CFR regulations.\nThe device must meet VA and local CAVHS policies for medical device connectivity, electrical safety, and cybersecurity.\n\nThe North American Industry Classification (NAICS) code for this acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The size standard is 1,000 employees.\n\nThis procurement is being conducted under Revolutionary FAR Overhaul (RFO) Federal Acquisition Regulation (FAR) Parts 12.102(a) Restricting Competition and FAR 5.101 Presolicitation Notice. This notice is not a request for quotes, but rather a notice of intent to sole source.\n\nThe anticipated award date is 26 March 2026. The Government intends to award a Firm-Fixed-Price contract.\n\nPlease note that this is not a request for competitive quotes and is being posted for information purposes only. The Government does not anticipate receiving responses to this notice. However, interested parties who disagree with this action may submit a letter of interest that demonstrates their firm s technical expertise, an original equipment manufacturer (OEM) authorization letter to sell/distribute OEM products. Interested vendors shall communicate how their product is compatible with existing fecal immunochemical testing (FIT) collection vials and VISN-wide standardization initiatives. Interested vendors shall communicate if their product is domestic or non-domestic. The Government reserves the right to verify any request for additional documentation submitted.\n\nInterested parties shall identify their interests, provide OEM authorization, personnel certifications/training as mentioned in Section V of this document, and demonstrate their capabilities to meet the Government s requirements. They must respond to this notice within fifteen (15) calendar days of the publication of this notice. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government.\n\nInterested parties may identify their interest solely via email to Contract Specialist, Carmyn E. Williams at Carmyn.Williams@va.gov no later than Monday, 09 March 2026 at 10:00 AM Central Standard Time (CST). When responding to this announcement, respondents should include 36C25626Q0383 Notice of Intent in the subject line.\n\nLate responses may not be accepted. No telephone inquiries will be accepted, nor will phone calls be returned. Only emailed responses will be considered. Information received will be used solely for determining whether to conduct competitive procurement. A determination not to compete with this proposed acquisition based upon response to this notice is at the sole discretion of the Government.\n"}