SOW.pdf

STATEMENT OF WORK

1. DESCRIPTION AND REQUIREMENTS OF THE CONTRACT

1.1 This is a Blanket Purchase Agreement Contract (BPA) pursuant to Federal Acquisition Regulation

(FAR) Part 12 and FAR Part 13.303 for the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22. This BPA is for a Cost Per Test (CPT) system that shall provide all Immunohistochemical (IHC) and In-situ hybridization (ISH) related testing within VISN 22. This BPA requires that the contractor shall provide a system that can conduct all testing as outlined in Attachment A. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed in 1.6. However, as requirements change, facilities within VISN 22 may be added or deleted by supplemental agreement between the Government and the Contractor.

1.2 This BPA does not obligate any funds. The Government is obligated only to the extent of authorized delivery/task orders (DO/TO) issued under the BPA by contracting officers (CO) for VISN 22 and the minimums established under section 1.3 which will be obligated via authorized DO/TO’s. All products ordered under DO/TO’s shall be subject to the terms and conditions of this BPA.

1.3 VISN 22 has provided estimated requirements in Attachment A. Additional items may be added to this BPA that are related to the use of IHC/ ISH requirements. All attachments identified in section D are hereby incorporated into this document as a part of the document itself, however this document shall supersede any conflicts of terms and conditions present in Section D attachments that may arise.

1.4 The BPA base period shall be for a period of five (5) years. Within the duration of this BPA, each facility may place orders within the ordering base and exercised options period of the BPA.

1.4.1 Base Period: (TBD upon award, target date of 09-15-2025)

1.5 Delivery Orders issued shall be identified by BPA Number (To Be Determined upon award).

1.6 Participating Facilities: (Additional Facilities within VISN 22 may be added to this contract with an exercise of a supplemental agreement between the CO and Contractor. Line items within the schedule should reflect the overall volume of all sites below and should take into consideration the potential addition of future facilities within VISN 22.

1.6.1 VA Loma Linda Healthcare System | 11201 Benton Street Loma Linda, CA 92357

1.6.2 VA Albuquerque Healthcare System | 1501 San Pedro Dr SE, Albuquerque, NM 87108

1.6.3 VA Phoenix Healthcare System | 650 E. Indian School Road Phoenix, AZ 85012

1.1 Schedule of Supplies and Services - Completed Attachment A shall serve as the Schedule of

Supplies and Services. All attachments identified in the table of contents shall be incorporated as a part of this contract document.

1.1.1 Cost Per Test in this BPA is defined as – Individual billing cost on a per test basis inclusive of all reagents, consumables, instrumentation, standard shipping, labor/services and installation as defined throughout section 1.7.

1.1.2 Attachment A, Tab 1, “VISN CPT” shall provide CPT pricing based upon other tabs in the Schedule which are also reflected in Column C. Column E provides the Total CPT for every test for years one (1) through five (5) of the BPA. The cost of instrumentation, software (not including annual licenses), other equipment and installation shall only apply to years one (1) – five (5) of the CPT or when the initial five (5) year volume is reached.

1.1.3 Attachment A, Tab 2, “EST ANNUAL SITE VOL” provides estimated test volumes for all minimally required tests under this BPA. These volumes are based upon current usage and utilize a 5% repeat rate and a 3% increase in volume as reflected in Tab 1.

1.1.4 Attachment A, Tab 3, “REAGENTS CPT” provides a component of the total Cost Per Test under column B for each required test. The amounts listed in column B only refer to the cost of reagents and consumables required to run a test and is reflected in Tab 1. Column D clearly identifies that exact quantities of reagents and consumables needed to a run a single test.

1.1.5 Attachment A, Tab 4, “INSTRUMENTS” provides what instrumentation and related equipment the contractor shall provide and their individual associated costs. Column L shall provide total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.1.6 Attachment A, Tab 5, “OTHER” provides what ancillary items and other items the Contractor shall provide as a part of the CPT. Also include training slot costs and other related services. Column L shall provide total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.1.7 Attachment A, Tab 6, “SERVICE” provides the CPT cost of service/maintenance and software licenses for duration of the BPA under column M.

1.1.8 Attachment A, Tab 7, “INSTALL” provides the cost of initial installation and a clear description of all installation activities. Column C provides total costs and an individual five (5) year CPT cost that is reflected on Tab 1.

1.1.9 Attachment A, Tab 8, “IND ITEM COST” provides the individual cost of all items within the CPT and items available to optionally purchase individual separate from the CPT.

1.1.9.1 Also includes the cost expedited shipping as individual line items by facility.

1.1.9.2 Includes the cost of additional training slots beyond the initial amount offered under the CPT.

1.2 Introduction and Scope of Required Specifications

1.2.1 The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work for all IHC and ISH.

The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meeting the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

1.2.2 Equipment must maintain or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory as defined by volumes in Attachment A.

1.2.3 The Contractor is required to provide a continuously stocked inventory of reagents, standards, antibodies, secondary stains, consumable supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment 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. Unexpected changes in methodology/technology shall be at the expense of the Contractor.

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.

1.2.4 Equipment: All equipment shall be new, state-of-the-art, and not recertified nor refurbished, and equal to the number of items necessary to meet the volume and service needs for each station. Equipment shall be acquired for each of the stations located at the following VISN 22 facilities: See section 1.6 and Attachment A.

1.2.5 Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for IHC/ISH equipment, supplies and related services.

1.3 Definitions

1.3.1 Cost per Test (CPT) – Individual billing cost on a per test basis inclusive of all reagents, consumables, instrumentation, standard shipping, labor/services and installation as defined throughout section 1.7. CPT pricing is billed per test as per Attachment A and Section 1.7.

1.3.2 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 in order 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.

1.3.3 Contractor Middleware System – Generally a separate component/ computer that electronically links the testing instrumentation to manage data, results and workflow. (Not to be confused with Data Innovations or Dawning).

1.3.4 Throughput – The speed that the equipment processes and/or operates reported in units per hour.

1.3.5 TEST MENU: Refer to Attachment A Tab 1 and 2 for test menu and estimated annual volumes by laboratory.

1.4 Instrumentation Requirements

1.4.1 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 technical specifications of this contract.

1.4.2 Contractor shall provide an Integrated Clinical Laboratory IHC and ISH Instrumentation in accordance with the Attachment A.

1.4.3 Fully automated instrument with the defined capabilities:

1.4.3.1 Baking

1.4.3.2 Deparaffinization

1.4.3.3 Cell Conditioning

1.4.3.4 Staining

1.4.3.5 IHC

1.4.3.6 ICC

1.4.3.7 ISH

1.4.3.8 SISH

1.4.3.9 DISH

1.4.3.10 Immunofluorescence

1.4.3.11 Multi-parameter IHC (double, triple)

1.4.3.12 Counter Stain

1.4.3.13 Titration

1.4.4 Instrument(s) provided shall have sufficient capacity and throughput to meet the volume and service demands as defined in Attachments A Tab 2 during peak workload analysis.

The solution should allow for 3% growth in volume per year for the term of the contract with options.

1.4.5 Instrument(s) shall have the ability to function properly in arid climates with humidity thresholds as low as 10%.

1.4.6 Instrument(s) shall have the ability to function properly and consistently in high altitude climates above 5,000 feet.

1.4.7 The capability of performing analysis on 100% of the required tests listed in section Attachment A with consistent stain quality that can be validated by Pathologists for each station regardless of altitude and climate.

1.4.8 A total instrument footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

1.4.9 System shall include a stain status display for staff review and workflow management for all integrated (linked) testing instrumentation. All monitors/screens will clearly display information in all light conditions.

1.4.10 Capability of barcode interface programming capability with the Laboratory Information System.

1.4.11 Random access capability.

1.4.12 The ability to continuously load patient slides for staining.

1.4.13 Ability to add/remove reagents without interrupting cases in process.

1.4.14 Flexibility to add/remove slides without impacting workflow.

1.4.15 The capability of incorporating third party stains on the instrument.

1.4.16 Instruments must offer easy to read, printable staining reports.

1.4.17 Instruments must have barcoded reagents that can be scanned on the instrument in all light conditions.

1.4.18 Instruments must have capability to ensure that one can’t use reagents if they are expired or if the volume of the reagents is insufficient to complete the run.

1.4.19 Instrument must have a reaction chamber that allows for full slide coverage.

1.4.20 Instruments must have easy slide insertion- with no extra pieces to position.

1.4.21 Instruments must automatically track insufficient reagent quantity and alert for tests remaining.

1.4.22 Button and barcodes automatically register and locate staining kits and slides.

1.4.23 Instrument must have independently functioning slide staining chambers to preserve sample integrity and eliminate the need for batch runs.

1.4.24 Minimum of 35 reagent positions.

1.4.25 Individually temperature-controlled slide drawers with continuous access to slides improves throughput.

1.4.26 Process up to 90 slides in 8 hours, or 120 slides with an overnight run.

1.4.27 Ability to add “STAT” requests with no interruption to routine runs.

1.4.28 The IHC platform(s) must be capable of completing multiple runs during an 8 hour day.

More than one platform shall be provided if necessary to maintain volume and service needs.

1.4.29 Simultaneous IHC, ISH, SISH, DISH, Dual Stain, and FITC slide processing and titration.

1.4.30 Ultimate Reagent Access (URA) provides frequent access to reagent.

1.4.31 Optimized protocols with flexible options including variable incubation times and temperatures.

1.4.32 Vendor must offer prepackage bulk solution reagent kits with no mixing

1.4.33 Continuous access to bulks and waste for improved workflow.

1.4.34 The IHC platform require provisions to reduce exposure to harmful chemicals to staff and the environment by deactivating DAB

1.4.35 Remote support with approved MOU/ISA for trouble shooting and training.

1.4.36 On-site training provided for each user.

1.4.37 Cost of service to be included in pricing for each instrument provided to meet service needs. (1st year instrument is under warranty and service is included in the remaining 4 years). Vendor must include preventive maintenance visits according to regulatory requirements, such as CLIA and TJC, decontamination visits to site to repair instrument when down, and technical support call line as part of the contract.

1.4.38 Printers and Other Support Items (Support Items)

1.4.38.1 A printer(s) that has the capability of printing inventory reports, protocol usage, and lot to lot confirmations. The contractor must repair or replace the printer if malfunctioning within 24 hours for the duration of the contract.

1.4.38.2 An uninterruptible power supply (UPS) with line conditioner 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.

1.5 Software, Connectivity and Conformance Standards

1.5.1 Instrument Software – Internal to testing instrumentation that provides/maintains the following:

1.5.1.1 Ability to monitor instrument performance.

1.5.1.2 Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records.

1.5.2 Interface

1.5.2.1 The contractor hardware and software proposed solution meets all VA

Information Security, Hardware, Software and Network requirements (See attachment VA 6500). Any wireless equipment must be FIPS 140-2 compliant as well, and contractor must provide the FIPS 140-2 certification for any wireless equipment upon request.

1.5.2.2 Must be compatible with specimen tracking systems, universal interface.

1.5.2.3 Upon request, the Contractor shall provide support for connecting to a specimen tracking system, including, but not limited to data lines, adapters, and licenses.

1.5.3 Connectivity and Conformance

1.5.3.1 The Contractor supplies responses to required documents in order to add systems to the VA network including but not limited to the VA Form 6550, Access Control List (ACL) Communication Protocol, MSD2, and the Risk Analysis Tool.

1.5.3.2 The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network (Windows 10 and Server 2012/2016).

1.5.3.3 Any software solutions supplied and installed on VA workstations by the contractor must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must be within 2 lifecycles of the most recent TRM approved version. Or the contractor must have the capability obtain a TRM approval without impacting installation timeframes in section 4.

https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx.

1.5.3.4 If providing remote support, the Contractor must have a Memorandum of Understand/Information Security Agreement (MOU/ISA) with the VA or the capability to obtain an MOU/ISA without impacting installation timeframes in section 4.

https://vaww.portal2.va.gov/sites/infosecurity/FY15CRISPAudit/CR

ISPRemediationContract/WorkSite/SitePages/MOU- ISA_Version2.aspx

1.6 Support Features

1.6.1 Service Maintenance / Warranty

1.6.1.1 The Contractor shall be able to provide equipment repair and preventative maintenance on all primary instrumentation and ancillary equipment within the provided system(s) according to manufacturer specifications, and laboratory regulatory bodies, such as CLIA, CAP, VA National Enforcement Office, and TJC.

1.6.1.2 The contractor provides a technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour

1.6.1.3 All equipment, including ancillary equipment, repair service shall be provided Monday through Friday from 8:00a.m. to 4:00p.m local time. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. If one analyzer is down service converts to 24/7 to maintain all operations. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time shall be no more than 4 hours. Delivery of parts and equipment to fix instrumentation must be within Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date or more frequently based on instruments’ performance.

1.6.1.4 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.

Cause (i.e. user error, part failure, etc…) Each notification for an emergency repair service call shall be treated as a separate and new service call.

1.6.1.5 The Contractor shall provide, install, maintain, and repair through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. UPSs with line conditioner, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, deionizers, filters, preventative maintenance and repair, 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, validation materials, tables/stands, etc.

1.6.1.6 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 on- line procedure manual in the instrument software.

1.6.1.7 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.

1.6.2 This section 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 go live 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 the BPA at an effectiveness level of 90% or more.

1.6.2.1 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.

1.6.2.2 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 at no charge 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.)

1.6.2.3 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.

1.6.2.4 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.

1.6.2.5 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.

1.6.2.6 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 may be made by the COR and contracting officer to replace the malfunctioning equipment with new equipment at no additional charge. 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 contract. The same terms and conditions apply to ancillary/support equipment provided under this BPA, i.e., water system, printers, UPS, etc.

1.6.2.7 The Contractor shall provide a warranty for all items and services provided under the BPA for the duration of the BPA and all associated delivery orders

1.6.3 Reports

1.6.3.1 All reports of validation and optimization must be approved by the medical director. Additional studies will be at the expense of the contractor until results meet the criteria defined by the medical director.

1.6.4 Training

1.6.4.1 The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility’s services. The CPT shall include key operator training for minimally 2 operators per each instrument installed. Training shall be provided on the operation of the system, data manipulation, and basic trouble shooting and repair.

Thereafter, the Contractor shall provide training for minimally two operators 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.

1.6.4.2 In addition, operator training shall be provided by Contractor on-site for all operators on all shifts (day shift: 0700 – 1530, evening shift: 1500 – 2330 and midnight: 2300 – 0730 local time), as applicable.

1.6.4.3 Additional onsite training will be provided 60-90 days after instrumentation’s go live date.

1.6.4.4 Contractor shall at minimum provide on-site training for up to 8 hours per site as requested by the facility.

1.6.4.5 Contractor will provide example policies and procedures such as standard operating procedure templates.

1.6.5 Waste

1.6.5.1 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 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR

§261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed)

(Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4)

1.6.5.2 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.

1.6.5.3 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, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review.

1.6.5.4 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

1.6.6 Upgrade/Updates: The Contractor shall provide updates 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 updates” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update 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 BPA; however, it does refer to significant changes in the hardware operational capability. Should the VISN decide to upgrade their current equipment ie. - replacement of existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

2. PACKAGING & MARKING

2.1 Packaging

2.1.1 All equipment and supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

2.2 Marking

2.2.1 All items shall be marked clearly with the BPA Number, Delivery Order Number, Obligation number and delivery location within the hospital ie.

Emergency Room. For major Equipment, the Obligation number shall begin with an A after the station number ie. 600A20000. All other service items shall be marked with a C number ie. 600C20001. The Delivery Order number shall have a format similar to this example: 36C26223N1234.

3. DELIVERIES & PERFORMANCE

3.1 Installation/Implementation

3.1.1 Implementation/transition timeframe: All sites shall have complete installation and go live of their system within one year of award of this BPA.

3.1.2 Contractor shall execute an implementation plan which includes:

3.1.2.1 Installation - Contractor shall make every effort to conduct a concurrent implementation at all sites with weekly collaborative meeting.

Contractor shall provide a dedicated project manager throughout the entire implementation. Installation shall also include conversion of all current data minimally including operator profiles.

3.1.2.2 Testing- Shall include at minimum a test of all analytes in addition through all testing phases (pre- analytical, analytical, and post-analytical). In addition, training must be provided to all sites.

3.1.2.3 Acceptance-Must meet the approval requirements of accrediting agencies and laboratory medical director approval at each facility to meet accreditation standards.

3.1.2.4 Go-Live- Dedicated project management and technical support must be available above the requirements the day of go-live at each site for 3 days.

3.1.2.5 Post Go-Live Follow Up- Check-in should include at least two weeks and 30 days after go-live date.

3.1.2.6 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. This applies to equipment as well as additional or replacement equipment placed under the terms and conditions of this BPA. The Contractor shall perform/, to the satisfaction of the Government, all validation studies including method comparison with current analyzer, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all statistical analysis as stated in the Method Performance/Validation section below and provide a hard copy of data in an organized, clearly comprehensible format.

3.1.2.7 Onsite Go live Instrument Support Requirements shall consist of 2 days of continuous support. Daily onsite support for a total of five business days for each phase of implementation.

3.1.3 Must support successful implementation.

3.1.4 Method Performance / Validation

3.1.4.1 The Contractor will assist (if needed) each VA Histology laboratory optimize each non-predictive factor assay. Note: Contractor will not help with laboratory-developed predictive marker assays.

3.1.4.2 Method performance/comparison shall be at the expense of the Contractor, shall include all reagents, and consumables to meet the validation standards defined by CLIA. standards and Federal regulations. All studies performed will be appropriate for the test menu of the respective laboratory to include histology, cytology, and bone marrow specimens (decalcified tissue). as applicable and must be approved by the medical director.

3.1.4.3 For initial analytic validation of non-predictive factor assays, each VA Histology laboratory should test a minimum of 10 positive and 10 negative cases. When a specific marker is less than 20 validation cases, the laboratory Medical Director will determine the quantity of cases to be sufficient for clinical service. The laboratory will add cases as an “on-going validation to meet the criteria of 10 positive and 10 negative cases. For initial analytic validation of all laboratory-developed predictive marker assays, (HER2, ER, PgR), each VA Histology laboratory should test a minimum of 20 positive and 20 negative cases. When a specific marker is less than 40 validation cases, the laboratory Medical Director must document the rationale for that decision. Note: Positive cases must include the expected clinical results (expression levels).

3.1.4.4 For initial analytic validation of all laboratory-developed predictive marker assays (with the exception of HER2, ER and PgR), each VA Histology laboratory should test a minimum of 20 positive and 20 negative tissue cases. When a specific marker is less than 40 validation cases, the laboratory Medical Director must document the rationale for that decision. Note: Positive cases must include the expected clinical results (expression levels).

3.2 Completion of Contract

3.2.1 Ownership of Equipment - Title to the equipment shall remain with the Contractor unless otherwise agreed. 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.

3.2.2 The 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 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.

3.3 Delivery: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in section 1.6.

3.3.1 The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility.

3.3.2 All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m local time. and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, BPA number, shipping address, delivery location, items/quantity ordered and items/quantity shipped. Standard orders shall be delivered within no more than 30 working days after receipt or placement of order.

3.3.3 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.

4. CONTRACT ADMINISTRATION DATA

4.1 Ordering, Invoice and Payment

4.1.1 The Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities shall place orders:

Name:

Address:

Phone No:

Fax No:

Contact:

Email:

For Accounts Receivable Name:

Contact:

Email:

4.1.2 Payment Address: The Contractor shall submit in arrears a completed individual itemized invoice in accordance with the address below.

VA Finance Center PO Box 149971 Austin, TX 78714

4.1.3 Invoice Information: The following information shall be listed on all invoices (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor).

4.1.3.1 Facility’s Name and address where service was provided

4.1.3.2 BPA Number (For Example :VA262-BP-0001)

4.1.3.3 Delivery Order Number (For Example: VA262-12-J-0001)

4.1.3.4 Obligation Number (For Example: VA600-C27001)

4.1.3.5 A Line Item break down of usage for example:

4.1.3.6 Line item 1 GI Scope Lease: 1 MO at $400.00

4.1.3.7 Line item 4 GI Service Maintenance: 1 MO at $10.00

4.1.3.8 Include the period of time that is being invoiced for in the invoice.

4.1.3.9 BPA Holder’s Internal Contract number (if applicable)

4.1.3.10 Include point of contact for concerns and questions. Contractor must name a specific person, phone number and email.

4.2 BPA Program Manager

4.2.1 The Contractor shall provide an BPA program manager who shall be responsible for the performance of the work under the BPA. In addition, the program manager shall act as the main focal point of communication between the Contracting Officer and the Contractor. The name of this person shall be designated in writing to the Contracting Officer. The program manager shall have full authority to act on behalf of the Contractor on all contractual/BPA matters relating to daily operation of the BPA.

Company Name:

Contact Name:

Email:

4.3 Hours of work

4.3.1 The BPA shall include a minimum five (5) days a week, 8:00a.m. to 4:00p.m local time, full-service agreement to include all necessary service calls.

Contractor shall also provide technical support via phone seven (7) days a week, twenty-four (24) hours a day. After hours and weekends in person service are chargeable as per line items within Attachment A.

4.3.2 Any service performed during other than normal work hours must be approved in advance by the facility COR or CO.

4.3.3 Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the COR in advance as approved in the delegation of authority. The rates shall be chargeable as per Attachment A.

New Year’s Day January 1st Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day First Monday in September Columbus Day Second Monday in October Veteran’s Day November 11th Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

4.3.4 When a National Holiday falls on a Sunday, the following Monday shall be observed as a

National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

5. SPECIAL BPA REQUIREMENTS

5.1 Physical Security and Facility Considerations

5.1.1 Identification, Parking, Smoking and VA Regulations (For any onsite services):

5.1.1.1 The Contractor employees and/or

Subcontractors shall wear visible identification at all times while on the premises of the facilities within the VISN. Identification shall include but not be limited to a company identification card, which shall include the company name, employee name, title, and a photograph of the employee.

5.1.1.2 It is the responsibility of the Contractor

to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section.

The will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

5.1.1.3 Any interior or exterior doors that shall

be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit.

At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person.

Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

5.1.1.4 Contractor personnel are required to

check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the COR. The Contractor’s staff shall also be required to sign in and out each day at a designated location determined by the COR.

5.1.1.5 The Contractor agrees that none of its

officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government

5.1.1.6 Smoking is prohibited inside any buildings at facilities within VISN 22.

5.1.1.7 Possession of weapons is prohibited.

Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

5.1.1.8 The Contractor shall not allow his/her

employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

5.2 Information Technology Security Considerations

5.2.1 Prior to termination or completion of this

Contract, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this Contract 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 Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the Contract.

5.2.2 All electronic storage media used on non-VA

leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the Contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier.

Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the Contract.

5.2.3 Bio-Medical devices and other equipment or

systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the contractor at the end of lease, for trade-in, or other purposes. The options are:

5.2.3.1 Contractor must accept the system without the drive;

5.2.3.2 VA’s initial medical device purchase

includes a spare drive which must be installed in place of the original drive at time of turn-in; or

5.2.3.3 VA must reimburse the company for

media at a reasonable open market replacement cost at time of purchase.

5.2.4 Due to the highly specialized and sometimes

proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

5.2.5 The equipment contractor must have an existing

BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact;

and

5.2.6 Any fixed hard drive on the device must be non-

destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or Contract.

5.2.7 A statement needs to be signed by the Director

(System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

5.2.8 In addition, please see Attachment H for

additional Information Technology terms and conditions. All terms and conditions of Attachment I shall apply to this BPA.