Inactive

Section B.2 is replaced in its entirety with the following (revisions in red text): B.2 DESCRIPTION OF REQUIREMENT Introduction: The VA Palo Alto Healthcare System (VAPAHCS) requires a contract vehicl... Section B.2 is replaced in its entirety with the following (revisions in red text): B.2 DESCRIPTION OF REQUIREMENT Introduction: The VA Palo Alto Healthcare System (VAPAHCS) requires a contract vehicle for Immunohistochemistry (IHC), In-Situ Hybridization (ISH), and Special Staining system to support the Pathology and Laboratory service. This system shall have a cost per reagent pricing structure which covers the cost of the reagents, instruments, service, and VA PAHSC staff training. The system shall provide tissue slides that are stained and read by pathologists to diagnose cancer and other pathological diseases. High quality stains and a high degree of automation is required for expanding workload in large referral center VA laboratory. Definitions: Immunohistochemistry (IHC) is a technique for identifying cellular or tissue constituents (antigens) relating to cancer and diseases by means of antigen-antibody interactions, with the antibody label coming from the reagent. In Situ Hybridization (ISH) techniques allow the demonstration of specific nucleic acid sequences (genes) in their cellular environment. Special staining techniques demonstrate the presence (or absence) of a celluar component that helps a pathologist diagnose cancer or a disease. Minimum Requirements: Instrumentation / Analyzer: Two (2) IHC-ISH analyzers capable of the following: Perform immunohistochemistry(IHC) and in situ hybridization (ISH) stains with the full range of techniques (immunohistochemical, immune special ISH, SISH, immunofluorescence, counterstain, titration) simultaneously on one instrument, Perform pre-processing (deparfination, bake) on the analyzers, Be fully automated (robotic) after adding samples to unit, Have STAT capability while other testing is in progress, Have ability to add slides while instrument is running other tests, Have ability to add or change reagents while instrument is running other tests, Have bar code tracking of samples and reagents, Have IHC turnaround time of 2.5 hours or less, Be a freestanding floor model to fit in existing VAPAHCS laboratory space of approximate dimensions 45 W x 32 D x 62 H. Two (2) Special Stains analyzers capable of the following: Perform special histology stains: AFB, alcian yellow, congo red, diastase, steiner, GMS, iron, PAS, reticulum, Stiner II, trichrome, Have the capacity to complete 20 slides in 30 minutes, including online baking/depar with ready to use reagents.  Turnaround time will vary depending on protocol.  Have a high degree of automated features for tracking patient slides, reagents, waste, maintenance, Single slide heating (independent control) and liquid cover slip technology, Have bar code tracking of slides, Be a free standing floor model. Data & System Management/Interface to support all provided instrumentation, capable of the following: Allow user to view status of patient tests during instrument operation, Have lab instrument and Contractor remote link support for troubleshooting and software upgrades, Have connectivity of IHC-ISH and Special Stain analyzers to data management system. The equipment models being quoted shall be in current production as of the date a quote is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Upgrades. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the initial contract vehicle; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment. The Contractor shall provide, install and maintain through the life of the contract vehicle, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Reagents / Tests: Shall have current FDA approved menu of IVD antibodies for IHS-ISH tests that will detect breast, prostate, lung and hemopathology cancers, Shall have the ability to provide IHC-ISH reagent markers from specialized companies that sometimes have proprietary reagents, Shall have a variety of special stains typically used in a histology laboratory (refer to 3.b.i.), Shall have fully automated assays without manual pre-treatment, Shall come in small kit sizes available whenever possible (less than 50 tests) to eliminate wastage/expired reagents. Instrument Service and Support: Provide technical and customer support service 24-hours, 7 days per week to provide troubleshooting support and to escalate the dispatch service personnel. Service Representatives shall be onsite within 24-48 hours based off of escalation, Provide off site training for at least one (1)1 key operator and onsite training as needed. Implementation and Installation: Contractor shall coordinate with VAPAHCS staff to coordinate installation requirements, to include electrical, plumbing, and space requirements, Contractor is responsible for all freight and shipping costs of all instrumentation, Contractor shall provide an implementation plan that details the resources, time frame, plan to install the requested instrumentation and data & system management interface, Contractor shall provide all validation reagents, supplies, etc. upon initial installation. Deliverables: Contractor shall provide a detailed monthly ordering report to the VAPAHCS to track reagent and contract spend rate. Additional information maybe be requested in monthly reports as determined by VAPAHCS and the Contracting Officer. Standard and Quality of Performance - Analyzers: This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract vehicle is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted at an effectiveness level of 90% or more. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. Standard and Quality of Performance Reagents, Delivery, Service, Etc.: Contract will be monitored relative to the quality of stains, timeliness of supply delivery, timeliness of service, when required, and submission of invoices.

Inactive

DESCRIPTION OF REQUIREMENT Introduction: The VA Palo Alto Healthcare System (VAPAHCS) requires a contract vehicle for Immunohistochemistry (IHC), In-Situ Hybridization (ISH), and Special Staining syst... DESCRIPTION OF REQUIREMENT Introduction: The VA Palo Alto Healthcare System (VAPAHCS) requires a contract vehicle for Immunohistochemistry (IHC), In-Situ Hybridization (ISH), and Special Staining system to support the Pathology and Laboratory service. This system shall have a cost per reagent pricing structure which covers the cost of the reagents, instruments, service, and VA PAHSC staff training. The system shall provide tissue slides that are stained and read by pathologists to diagnose cancer and other pathological diseases. High quality stains and a high degree of automation is required for expanding workload in large referral center VA laboratory. Definitions: Immunohistochemistry (IHC) is a technique for identifying cellular or tissue constituents (antigens) relating to cancer and diseases by means of antigen-antibody interactions, with the antibody label coming from the reagent. In Situ Hybridization (ISH) techniques allow the demonstration of specific nucleic acid sequences (genes) in their cellular environment. Special staining techniques demonstrate the presence (or absence) of a celluar component that helps a pathologist diagnose cancer or a disease. Minimum Requirements: Instrumentation / Analyzer: Two (2) IHC-ISH analyzers capable of the following: Perform immunohistochemistry(IHC) and in situ hybridization (ISH) stains with the full range of techniques (immunohistochemical, immune special ISH, SISH, immunofluorescence, counterstain, titration) simultaneously on one instrument, Perform pre-processing (deparfination, bake) on the analyzers, Be fully automated (robotic) after adding samples to unit, Have STAT capability while other testing is in progress, Have ability to add slides while instrument is running other tests, Have ability to add or change reagents while instrument is running other tests, Have bar code tracking of samples and reagents, Have IHC turnaround time of 2.5 hours or less, Be a freestanding floor model to fit in existing VAPAHCS laboratory space of approximate dimensions 45 W x 32 D x 62 H. Two (2) Special Stains analyzers capable of the following: Perform special histology stains: AFB, alcian yellow, congo red, diastase, steiner, GMS, iron, PAS, reticulum, Stiner II, trichrome, Have a special stains turnaround time of 20 slides in 20 minutes or less, Have a high degree of automated features for tracking patient slides, reagents, waste, maintenance, Single slide heating (independent control) and liquid cover slip technology, Have bar code tracking of slides, Be a free standing floor model. Data & System Management/Interface to support all provided instrumentation, capable of the following: Allow user to view status of patient tests during instrument operation, Have lab instrument and Contractor remote link support for troubleshooting and software upgrades, Have connectivity of IHC-ISH and Special Stain analyzers to data management system. The equipment models being quoted shall be in current production as of the date a quote is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Upgrades. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the initial contract vehicle; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment. The Contractor shall provide, install and maintain through the life of the contract vehicle, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Reagents / Tests: Shall have current FDA approved menu of IVD antibodies for IHS-ISH tests that will detect breast, prostate, lung and hemopathology cancers, Shall have the ability to provide IHC-ISH reagent markers from specialized companies that sometimes have proprietary reagents, Shall have a variety of special stains typically used in a histology laboratory (refer to 3.b.i.), Shall have fully automated assays without manual pre-treatment, Shall come in small kit sizes available whenever possible (less than 50 tests) to eliminate wastage/expired reagents. Instrument Service and Support: Provide 24-hour, 7 days per week customer service, Provide onsite service and arrive within 4 hours of emergency calls placed Mon-Fri between 7 am 3 pm, Provide off site training for at least one (1)1 key operator and onsite training as needed. Implementation and Installation: Contractor shall coordinate with VAPAHCS staff to coordinate installation requirements, to include electrical, plumbing, and space requirements, Contractor is responsible for all freight and shipping costs of all instrumentation, Contractor shall provide an implementation plan that details the resources, time frame, plan to install the requested instrumentation and data & system management interface, Contractor shall provide all validation reagents, supplies, etc. upon initial installation. Deliverables: Contractor shall provide a detailed monthly ordering report to the VAPAHCS to track reagent and contract spend rate. Additional information maybe be requested in monthly reports as determined by VAPAHCS and the Contracting Officer. Standard and Quality of Performance - Analyzers: This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract vehicle is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted at an effectiveness level of 90% or more. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. Standard and Quality of Performance Reagents, Delivery, Service, Etc.: Contract will be monitored relative to the quality of stains, timeliness of supply delivery, timeliness of service, when required, and submission of invoices.