Attachment B - SOW.docx

ATTACHMENT A - STATEMENT OF WORK

VISN 22 Infectious Molecular Pathology IDIQ Introduction The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to VISN 22 sites (see below).

Background The VISN22 Pathology and Laboratory Medicine Service is in need of reagents, consumables and services to support infectious disease testing on the Roche Cobas 5800 systems.

1. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

1.1. SCOPE OF PROCUREMENT:

1.1.1. The base period shall be for a period of 1 year with four one-year options.

1.1.2. The following facilities currently within VISN22, and future facilities that fall under the authority of NCO22, may be added or deleted to this agreement with an exercise of a supplemental agreement between the government and the contractor.

1.1.2.1. Participating facilities:

1.1.2.1.1. VA Greater Los Angeles Healthcare System (GLAVAHCS)

1.1.2.1.2. VA Long Beach Healthcare (LBVAHCS)

1.1.2.1.3. VA Northern Arizona (NAVAHCS)

1.1.2.1.4. VA Loma Linda Healthcare System (LLVAHCS)

1.1.2.1.5. VA Albuquerque (NMVAHCS)

1.1.2.1.6. VA Phoenix Healthcare System (PVAHCS)

1.1.2.1.7. VA Southern Arizona Healthcare System (SAVAHCS)

1.1.3. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, 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 shall 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 shall be forwarded to the designated individuals determined at contract award.

1.1.4. 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.

1.2. DEFINITIONS:

1.2.1. Cost per Kit (CPK) - Contractors are required to provide a price for each kit that can be used on its equipment to run each test. The per kit price shall include costs covering (1) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Roche Cobas 5800 necessary for the generation of reporting of a test result and (2) training for Government personnel. (3) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) shall be billed as annual line items and not included in the cost per kit. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

1.2.2. 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 receive, 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. SALIENT CHARACTERISTICS AND GENERAL REQUIREMENTS

2.1. TEST MENU

2.1.1. The capability of performing analysis on 100% of the tests listed in Attachment A. All assays should be FDA cleared and compatible with the VA owned Roche Cobas 5800 molecular instrument. Assays should be equal to or equivalent to the following assays:

2.2. ACCESSORIES

2.2.1. Evalyn brush, product number 9032959190, that is part of the FDA clearance for self-collection of HPV testing

2.3. REAGENTS and CONSUMABLES

2.3.1. Ready to use reagents. No preparation requirement. Reagents able to be directly loaded with tracking performed by RFID chips. Ready to use reagents with minimal preparation requirements allow Medical Laboratory Technicians in the operation and testing instead of Medical Technologists which helps relieve the impact on staffing.

2.3.2. Minimal reagent calibration required.

2.3.3. Contractor to provide expiration dates of at least 6 months for reagents.

2.3.4. Vendor shall provide on-board reagent and supply stability timeframe for 1.2.3 test menu.

2.3.5. Vendor shall provide reagent and supply stability off-board timeframe after on-board use for 1.2.3 test menu.

2.3.6. Reagents must be pre-calibrated.

2.3.7. Contractor shall provide assayed quality control material at a minimum of three levels: low positive, high positive and negative for quantitative testing and negative and positive for qualitative.

2.3.8. Contractor shall supply reagents and consumables to support third-party assay testing for Candida auris as indicated by the test volumes in Attachment A.

2.3.9. The instrument's IVD-cleared assays shall be classified as CLIA Moderate Complexity. HIV Viral Load test must have the following features:

2.3.9.1. The HIV test must be designed with dual target amplification – two regions are targeted, which are highly conserved and not drug targets.

2.3.9.2. The HIV test must include a QS (Quantitation Standard) that acts as an internal control and is co- amplified with the target for the purpose of titer calculations within each reaction.

2.3.9.3. Uracil-N-glycosylase or similar enzyme must be included in each reaction to ensure degradation of carry-over amplicon from prior reactions.

2.3.9.4. The HIV viral load test must have a linear range of as low as 20 copies/mL up to 10,000,000 copies/mL

2.3.9.5. The HIV test must require a small amount of initial sample

2.3.9.6. The HIV test must have a moderate complexity classification.

2.3.10. HCV Viral Load test must have the following features:

2.3.10.1. The HCV Viral Load must be a monitoring assay with a confirmatory claim to be used as an aid in diagnosis of HCV infection.

2.3.10.2. The HCV test must have a dual probe design that provides built in redundancy against current and potential future polymorphisms

2.3.10.3. The HCV test must have a moderate complexity classification.

2.3.10.4. The HCV test must require a small amount of initial sample.

2.3.10.5. Uracil-N-glycosylase or similar enzyme must be included in each reaction to ensure degradation of carry-over amplicon from prior reactions.

2.3.10.6. The HCV viral load test must have a linear range of as low as 15 IU/ml – 100,000,000 IU/ml

2.3.10.7. The HCV test must include a QS (Quantitation Standard) that acts as an internal control and is co-amplified with the target for the purpose of titer calculations within each reaction.

2.3.11. HPV must include a primary screening claim and have a cellularity control (Beta globin) to ensure effective sample collection.

2.3.12. CT/NG – Must contain an internal control to help prevent reporting false negative results.

2.4. REPORTABLE RANGE REQUIREMENTS

2.4.1. All quantitative VL assays: HIV Viral Load, HCV Viral Load, HBV Viral Load, assays– Contractor shall provide accurate high and low reportable range limits.

2.5. REPORTS

2.5.1. 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. 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 contract. Attachment A may be used as a template to provide these quarterly reports.

2.6. SUPPORT FEATURES

2.6.1. Equipment Preventative Maintenance/Repair Service. For base year, the following activities will be covered under equipment warranty. For subsequent years, 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:

2.6.2. Service Requirements

2.6.2.1. 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.

2.6.2.2. Equipment repair response time shall be no more than 24 hours.

2.6.2.3. Service agreement to cover 7 days per week, business hours (8AM-4:30PM local time)

2.6.2.4. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

2.6.2.5. 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:

2.6.2.5.1. Date and time notified

2.6.2.5.2. Date and time of arrival

2.6.2.5.3. Serial number, type, and model number of equipment

2.6.2.5.4. time spent for repair, and

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

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

2.6.2.8. Staff must be Roche trained and certified to work on Roche instrumentation.

2.6.2.9. Staff must be Roche certified to work on the Roche Cobas 5800s.

2.6.3. Upgrades:

2.6.3.1. The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability.

2.6.4. Ancillary support equipment :

2.6.4.1. The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

2.6.5. Interface Requirements

2.6.5.1. 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.

2.6.5.2. The Contractor shall provide any and 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.

2.6.5.3. 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.

2.6.5.4. 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 VA computerized hospital information system.

2.6.5.5. 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 going to the VA computerized hospital information system.

2.6.5.6. The Contractor shall provide remote support which requires a VA national MOU/ISA between Contractor and VA prior to award. Contractor shall include a copy of the current, valid MOU/ISA as part of their quote with the file named “VA MOU/ISA”.

2.6.5.7. 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. electronic procedure manual in CLSI format or an on-line procedure manual in the instrument software. If available, software for QC trending and positivity rate tracking.

2.6.5.8. 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. Documentation shall be submitted as an attachment to the Contractor’s quote and the file shall be named “Characterization of Waste – Section 2.6.5.8.”.

2.6.5.9. The determination and description shall address the following:

2.6.5.9.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24)

2.6.5.9.2. Waste ignitability (Reference 40 CFR §261.21)

2.6.5.9.3. Waste corrosivity (Reference 40 CFR §261.22)

2.6.5.9.4. Waste reactivity (Reference 40 CFR §261.23)

2.6.5.9.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31)

2.6.5.9.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33)

2.6.5.9.7. Solid Waste (Reference 40 CFR §261.2)

2.6.5.9.8. Exclusions (Reference 40 CFR §261.4)

2.6.5.9.9. 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 shall fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

2.6.5.10. 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 shall be determined and documented. Any mercury containing reagents shall 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, thimerosal and formaldehyde) shall be developed and SDS sheets shall 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 shall be included with Contractor response:

2.6.5.10.1. Chromium (Total)

2.6.5.10.2. Cyanide (Total)

2.6.5.10.3. Lead (Total)

2.6.5.10.4. Mercury (Total)

2.6.5.10.5. Nickel (Total)

2.6.5.10.6. Silver (Total)

2.6.5.10.7. Zinc (Total)

2.6.5.10.8. Arsenic (Total)

2.6.5.10.9. Selenium (Total)

2.6.5.10.10. Tin (Total)

2.6.5.10.11. pH

2.6.5.10.12. Flash point (to higher than 200°F)

2.6.5.10.13. BOD; biochemical oxygen demand

2.6.5.10.14. 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. Documentation shall be submitted as an attachment to the Contractor’s quote and the file shall be named “Description of Waste – Section 2.6.5.10.”.

2.6.5.11. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

2.6.5.12. Upon award of a contract, the transition period for the awarded contract to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

2.6.5.13. At the end of 90 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract.

2.6.6. Standard and Quality of Performance - This paragraph establishes a standard of quality performance that shall be met before any replacement equipment listed on the delivery order or contract is accepted by the Government. This 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 contract at an effectiveness level of 90% or more.

2.6.6.1. 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.

2.6.6.2. 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 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.)

2.6.6.3. 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.

2.6.6.4. 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.

2.6.6.5. 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.

2.6.6.6. During the term of the contract, shall the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment.

2.6.6.7. 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.

2.6.6.8. 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.

2.6.6.9. The Contractor shall 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 shall purge all patient sensitive information prior to departure from the facility.

2.6.6.10. Prior to termination or completion of this contract, Contractor/subcontractor shall 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 shall 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 shall be sent to the VA Contracting Officer within 30 days of termination or completion of the contract.

2.6.6.11. 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 shall 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 shall be returned to the VA for sanitization or destruction or the Contractor/subcontractor shall self-certify that the media has been disposed of per 6500.1 requirements. This shall be completed within 30 days of termination or completion of the contract or disposal or return of the IT equipment, whichever is earlier.

2.6.6.12. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information shall not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are:

2.6.6.12.1. Contractor shall accept the system without the drive;

2.6.6.12.2. VA’s initial medical device procurement includes a spare drive which shall be installed in place of the original drive at time of turn-in; or

2.6.6.12.3. VA shall reimburse the company for media at a reasonable open market replacement cost at time of purchase.

2.6.6.12.4. 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;

2.6.6.12.5. The equipment Contractor shall have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and

2.6.6.12.6. Any fixed hard drive on the device shall 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.

2.6.6.12.7. 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 Information Security Officer (ISO) needs to maintain the documentation.