Attachment B. SOW.docx

STATEMENT OF WORK VISN 22 Hematology Indefinite-Deliver Indefinite-Quantity (IDIQ),

2.1.1 Introduction to Required Specifications

2.1.0 The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supply, disposables and any other materials required to properly perform tests on the VA owned 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. Reagent expiry dates of 6 months or better is required to the maximum extent practicable when allowed by production methods (calibrators and control material is generally excepted). Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notifications 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 Contracting Officer Representative (COR). These individuals shall be identified upon award of the IDIQ.

Special Handling for Emergency Orders of Supplies: If 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.

Industry Standards – Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Hematology equipment, supplies and services.

2.2 Definitions

2.2.1 Cost per Test (Hereafter referenced as CPT) –includes the following:

· Reagents (amount needed to perform the total of tests specified by the participating facility for the fiscal year), controls, consumables, service, parts, training, and standard shipping.

2.2.2 Consumable and Reagent Definition: The contract must include all supplies, reagents consumables required for operation of the analyzer system. This includes all reagents, calibrators, controls for the CBC analyzer and slide maker stainer (SMS). This includes consumable hardware such as needles, probes, syringe tips, automated pipette tips/ and supplies. This includes printer ribbons for specialty printers such as SMS slide printers, Stains, buffers, diluents, and cleaners. This includes supplies for ancillary equipment such as water system filters, membranes and polishers, uninterruptable power supplies, air filters, light bulbs, specialty barcode labels.

2.2.4 Complete Blood Count (Hereafter referenced as CBC) and:

2.2.5 Automated Differential (Hereafter referenced as DIFF) and reticulocyte

2.2.7 Business Associate Agreement (Hereafter referenced as BAA) - A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, 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 everyone 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.

2.3 Operational/Technical Features: The instrumentation offered shall provide the following capabilities:

2.3.1 The vendor shall supply reagents, supplies and consumables for the performance of the tests and volumes outlined in Attachment A on the VA owned equipment that are brand name or equal to the Sysmex reagents. The list of reagents, supplies and consumables includes the items below but would not be limited to.

2.3.2 The vendor shall provide replacement parts and consumables for the VA owned instrumentation listed in Attachment A for the performance, service, and maintenance of the instrumentation. The list of parts, supplies and consumables includes the items below but would not be limited to.

2.3.3 Vendor shall supply cost for yearly software licenses of the products defined in Attachment A.

2.4 Service and Maintenance Plan –

2.4.1 The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation and any incremental support equipment, e.g., water system, offered according to the following terms:

2.4.2 A technical assistance center shall be available by telephone 24 hours per day. Technical assistance shall be available within an hour.

2.4.3 Equipment repair service shall be provided five days a week from 07:00AM to 07:00PM. Service will include a technician on site within four hours of call for service. Circumstances such as all equipment completely non-functional will convert service to 24 hours per day, 7 days per week. The service and support must include the digital morphology review system, as well as the analyzer, automation track, slide maker stainer and any middleware solutions, and ancillary equipment such as water conditioners and air filters.

2.4.4 Equipment repair service response time shall be no more than four hours from time of call. For parts that are not immediately available replacement parts will be available within 24 hours.

2.4.5 Preventive maintenance will be performed as required per manufacturer’s requirements or more frequently based off instrument performance.

2.4.6 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

· Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

· Repair details and replaced items.

· Cause (i.e., user error, part malfunction, etc…)

· Each notification for an emergency repair service call shall be treated as a separate and new service call.

2.4.2 2.4.3 2.4.4 2.4.5 2.4.6

2.4.7 The Contractor shall provide, install, maintain, and repair through the life of the IDIQ, as indicated, 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, tables/stands, etc.

2.4.8 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.

2.4.9 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

2.5 Training.

2.5.2 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.

2.5.3 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), as applicable.

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

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

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

2.6 Upgrade/Updates –

2.6.2 The Contractor shall provide updates to both the equipment hardware and software to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government.

2.6.2.1 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, i.e., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

2.6.3 The operating system must match the current requirements of the VA system and will be updated upon request as they become commercially available and at the same time as they are being provided to commercial customers.

2.6.4 Vendor shall provide the government the option to replace any equipment that has the following issues below at no additional charge including all installation associated startup costs.

2.6.4.1 Cumulative Downtime of more than 10% in any given month calculated on an hourly basis

2.6.4.2 More than three repeated equipment failures within a month of the same type of failure

2.6.4.3 More than five repeated equipment failures within a quarter of the same type of failure

2.6.5 Lemon Clause - Swab of instrumentation due to service exceeding X per year, the instrument may be exchanged at no cost to the government

2.7 Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter’s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. At the end of each BPA year (base and each option), an annual report of sales by participating facility as well as a VISN total will be provided. In addition, a total BPA sales/savings report will be provided at the expiration of the BPA, to include any extensions. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. These reports will be in an Excel spreadsheet, multiply tabs may be used, to include a VISN summary tab. Attachment C may be used as a template to provide these quarterly reports.

2.4 2.5 2.6 2.7

2.8 Data/Instrument Management System

2.8.2 See Section 6.3 for Information Technology Requirements

2.8.3 Interface Requirements

2.8.4 The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A).

2.8.5 The Contractor shall provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A.

2.8.6 The Contractor is responsible for everything leading up to the middleware including any incremental fee required to add additional equipment (e.g., licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

2.8.7 The vendor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500). Any wireless equipment must be FIPS 140-2 compliant as well.

2.8.8 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.

2.8.9 If there are software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA Laboratory Interface Middleware.

2.8.10 Contractor must have existing VA MOU/ISA prior to award which must include remote monitoring and support. Contractor should use remote monitoring to prevent instrument or testing issues as possible in addition to troubleshooting and support. The Contractor shall include a copy of the MOU/ISA as part of their quote with the file named “VA MOU/ISA”. The Contractor shall provide all hardware and software in order to implement the remote support system.

2.8.11 Sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.

2.8.12 Patient status display for technologist review and workflow management for all integrated (linked) testing instrumentation.

2.8.13 Ability to retransmit patient records to universal interface system in case of interface outage.

2.8.14 Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing)

2.8.15 Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology).

2.8.16 Technology must interface to VA licensed Data Innovations Instrument Manager sending all appropriate information in order to complete auto verification rules processing within the VA licensed IM.Preferred, but not required, that no additional middleware be necessary to connect instruments beyond the VA licensed DI IM.

2.8.17 Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

2.8.18 Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow. This shall include sending personnel back on site to optimize the analyzer, automation and data management work flows six months and twelve months after the system has gone live.

2.8.19 Optimization must include supplier to provide minimum staffing levels for pre-analytical, analytical, and post-analytical test performance.

2.8.20 When requested, the contractor shall help sites implement an auto verification from the VA licensed DI IM middleware rules package.

2.8.21 The vendor shall provide all hardware and software in order to connect the system to the existing VA network. If vendor provides remote technical assistance, must be approved with an ISA/MOU and vendor shall provide all hardware and software in order to implement the remote technical assistance solution.

2.8.22 Remote Access: The Contractor may include remote access features into their maintenance and service plan. To activate this particular function, the Contractor shall first receive approval from the VISN Information Security Officer (ISO) and the approval of the VA Office of Cyber Information Security (OCIS).

2.8.23 Ancillary support equipment - The Contractor shall provide, install, and maintain, as indicated, 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.

· The vendor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below).

· The vendor shall provide all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below.

· If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g., licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with Data Innovations and ultimately VistA. If there are any software upgrades in the instrument during its life, the

· Contractor is responsible for seeing that the interface can accommodate any changes in the data stream connected to VistA.

2.8.23.1 Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g., Computer disc containing their procedure manual or an on-line procedure manual in the instrument software.

2.9 Characterization of Hazardous Waste

2.9.2 The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The 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)

· The Contractor shall provide a written guide describing the proper disposal and care of all reagents, consumables, and equipment.

· The Contractor shall also provide their own reports of effluent studies associated with their instrument.

· The Contractor shall also provide documentation to the VISN concerning any items in this acquisition that contain cyanide.

· Vendor shall supply all applicable SDS sheets for the reagents and chemicals used by the system.

What you want in the proposals other than their basic writeup

Pricing Sheet

· Includes cost of when equipment will be removed from CPT based upon meeting volumes and require contractor to provide what volume is required to meet this item

· Completed spreadsheet

· Broken out costs to include – service, equipment, reagents/consumables

· Identify which consumables not included in CPT

· Identify additional costs for one-time charges

· Moving analyzer

· Additional training

· Maint/Repair outside of service plan Installation Installation Plan - Equipment installation requirements must be assessed and included in the proposal (e.g., construction, electrical and/or plumbing). Any requirements not identified in the proposal; the contractor will be responsible for all associated charges.

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