6640--PAP Testing

Page 4 of 15 This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) UIE number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below Work to be performed: .. Scope of Procurement: INTENT: it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish a Blanket Purchase Agreement (BPA) for a CPT Liquid based PAP testing instrumentation for GYN and Non GYN samples, and associated reagents. The BPA shall be a single vendor award for Cost Per Test placement of both instrumentations. The contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed in Attachment A and awarded in the final BPA. Additional instrumentation and reagents may be added to the BPA as new technology becomes available on the market. ORDERS: This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders issued under the BPA by authorized individuals. PRICES AND TERMS: VISN 15 will provide an estimated volume by reagent/supplies as reflected in Attachment A for each individual medical center. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY. If Contractor offers a family of analyzers, the technical evaluation panel will determine if instrumentation proposed meets needs of using facility. TERM OF AGREEMENT: This will be a single contractor award, firm-fixed price BPA with one base plus four one-year options. VISN 15 intends to establish the Base year of the agreement for the period of 11/1/2023 through 10/30/2024. Award is needed in September; two (2) months prior to expiration of current contract to allow for delivery, installation, training, and completion of validation studies required by laboratory standards. ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile, or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. DELIVERY TERMS: The delivery terms for all items ordered under the BPA will be FOB Origin. Contractor will make shipping arrangements and prepay all shipping and handling costs. Contractor will promptly replace all Products lost or damaged in shipment. Contractor will be responsible for all disputes with the shipper and all insurance claims related to the shipment. General Requirements: The desired instrumentation and associated reagents shall have the capability of performing as defined in the statement of work. The desired instrumentation and associated reagent shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A. The Contractor is required to provide a continuously stocked inventory of reagents, controls, and supplies required to ensure that patient care operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards, and control containers. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. Definitions: Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. MOU - The VA utilizes a Memorandum of Understanding (MOU) to document the terms and conditions for sharing data and information resources in a secure manner. The following supporting information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. Additionally, the MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnection. ISA -Technical details on how the interconnection is established or maintained are included within the Interconnection Security Agreement (ISA). A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems; to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections. Reagent Menu: Refer to Attachment A for desired reagent menu and estimated annual volumes. This solicitation uses a Brand Name or Equal Description of the product required. This permits prospective contractors to offer products other than those specifically referenced by brand name. Specifications/Salient Characteristics Ability to provide two primary analyzers for each site. Primary analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. Back-up Analyzer; equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e., reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Additional primary analyzers required for the performance of daily workload are not considered back-ups for the purposes of consumables, reagents, etc. Operational Features- The instrumentation offered shall have the following: Must be FDA approved for Liquid Based Cytology testing. The capability to automate preparation of liquid based PAP testing for both GYN and non GYN samples. Technical Features: Liquid Based PAP Testing for GYN and non-GYN samples shall: Utilize thin layer technology. Utilize one slide per case. Provide for standardization of processing, allowing for less variation from slide to slide and less potential for error. Utilize PAP collection device that is used in conjunction with the instrumentation but be approved for adjunctive HPV testing. Ability to upload up to 20 thin samples Ability to accommodate up to 20 slides and filters Ability to be walkaway instrument Ability to match the slide with vial automatically Ability to uncap/decap vial automatically Ability to load/unload samples automatically Hardware Features: The instrumentation shall have the following: All monitors/screens will clearly display information in all light conditions. An uninterruptible power supply (UPS) for each instrument provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. Analyzers must be bench top in design. Cerner Compatibility Statement Vendors providing a bid to this requirement shall provide a Cerner Compatibility Statement (CCS)from the OEM of the equipment. The CCS must include the following: An OEM attestation that the product proposed is Cerner verified. The statement must be dated within 60 days of the quote to ensure it is recent and accurate. A list of VA healthcare organizations that have deployed the device/system with the Cerner EHR. Details related to any data to be transmitted to Cerner. The statement must provide an OEM point of contact for questions or concerns related to Cerner compatibility. The proposal must declare if the device/system does not connect to the network or electronic medical record. Vendor bids that do not include a CCS directly from the OEM will be disqualified. All devices running windows must be Windows 10 OS at the time of award. Method Performance/Validation Requirements: Method Optimization shall be at the expense of the Contractor, shall include reagents, and be consistent with current College of American Pathologists (CAP) standards and Federal regulations. Validation for each analyte. A minimum of 5 samples, shall be run by the present and the proposed method. Studies shall be at the expense of the vendor. Vendor should provide their proposed implementation plan. Implementation/Transition timeframe: The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 60 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted plan shall not exceed 60 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations. Failure of the contractor to confirm to the transition period shall be considered as sufficient to terminate BPA for cause under the Termination for Cause clause of the BPA. At the end of 60 days from award of the BPA, the awarded contractor shall have full and sole responsibility for services under the awarded BPA. Other Requirements: Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Support Features-The equipment models being offered shall be in current production as of the date this offer is submitted. 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. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer 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. Commercial offerings. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g., Computer disc containing their procedure manual in CLSI format or an online procedure manual in the instrument software. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories, and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. Training. Upon Installation: The Contractor shall provide advanced (key operator) instrument training program for at least two operators per facility at no charge to the Government that is coordinated with and timely with the equipment installation, 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 troubleshooting and repair. Thereafter: The Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant. Unlimited on-site training should be available for training of new staff member, when instrumentation upgrades occur or when deemed necessary as a follow-up to troubleshooting of an instrument or staining issue. Service Requirements Equipment Preventative Maintenance/Repair Service: The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, offered according to the following terms: Phone support will be available Monday Friday 8:00 AM to 5:00 PM. All services for this contract must meet manufacturer s performance and technical specifications, Federal Regulations, FDA device certification and other specifications that may apply such as National Electric Code (NEC), Life Safety Code (LSC), the Joint Commission (JC), and VA Regulations. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified, date and time of arrival serial number, type and model number of equipment, time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Contractor must provide the appropriate service documentation to no additional expenses. Contractor shall provide hardcopy proof, upon request by COR, that contracting entity is a certified manufacturer service provider and that technicians are current in device certification training. Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than 24 hours. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. Each notification for an emergency repair service call shall be treated as a separate and new service call. The contractor shall provide maintenance both remotely (via off site service location) and on site, to include all replacement parts, software updates, labor, travel expenses, tools, test equipment, shipping costs, insurance costs for shipment and other incidentals necessary to maintain or restore the listed equipment to maintain or restore the listed equipment to operating specifications which meet or exceed the manufacturer s specifications. All parts used must be new or factory rebuilt for that model and type of device. In-house Biomedical engineering will provide first look response to all trouble calls. Vendor will repair or replace the instrument within ten (10) working days after receipt of the malfunctioning instrument. COR will notify contractor when services are needed. Contractor will resolve the issue by one or more of the following: shipment of new or factory rebuilt parts to Customer with appropriate instructions for installation of the parts on an exchange basis, shipment of new or reconditioned replacement instrument that is at least functionally equivalent to the original instrument on an exchange basis, shipment of a new, in-service, or reconditioned instrument that is at least functionally equivalent to the original instrument on a temporary loan basis, assistance of authorized distributors or service technicians or issuance of a return material authorization for Customer to return the instrument or defective component for repair or replacement. Upon receipt by Customer of the replacement part or replacement instrument, the original part or instrument becomes property of the vendor and shall be returned by customer to vendor. Customer shall pay to vendor the retail value of the replacement part or Instrument if vendor does not receive the original part within twenty (20) days after customer s receipt of the replacement part or replacement analyzer. Upgrades: The Contractor shall provide upgrades to the equipment hardware, bidirectional interface, and software to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government if sites are interested. 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 the software, correction of a hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace the model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; 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 agreement, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. universal interface equipment. 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, etc. Characterization of waste: The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated. The determination and 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) Solid Waste (Reference 40 CFR261.2) Exclusions (Reference 40 CFR261.4) The Contractor will provide written instructions and training material to ensure VHA Laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the Contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR 261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F,U,K and P) found in 40 CFR 261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e., mercury, thimerasol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with Contractor response: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH (Total) Flash Point (to higher than 200F) BOD; biochemical oxygen demand The documentation the Contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system. Standard and Quality of Performance: This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] 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 in any BPA at an effectiveness level of 90% or more. If equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue 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 more than the minimum of 100 hours. The government will maintain daily records to satisfy the requirements of this paragraph 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. [reference: master FSS ] Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. Government s Responsibility: The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Ownership of Equipment: Title to the equipment shall remain with the contractor. All accessories (unused consumables, etc.) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. The vendor/contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any vendor/contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. Prior to termination or completion of this BPA, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor while performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Medi...