Final SOW - Roche Cobas CPT 6800.5800 - FY24_27.docx

STATEMENT OF WORK – Roche Cobas Reagents, Supplies and CPRR

I. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

A. BPA LANGUAGE

1. INTENT: The Department of Veterans Affairs, VISN 1, Pathology and Laboratory Medicine Service (P&LMS) Molecular and Virology Department at VA West Haven requires FDA approved reagents and supplies compatible with the VA owned Roche COBAS 6800 for Specialized Virology and Molecular testing. In addition, VA West Haven requires backup instrumentation to the Roche COBAS 6800.

As requirements change, facilities within VISN 1 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market.

2. ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals.

3. PRICES AND TERMS: VISN 1 will provide an estimated volume by test. Pricing is based on these estimated test volumes. The Government does not guarantee volumes as listed; they are estimates ONLY.

4. TERM OF AGREEMENT: This will be a single award, 3-year fixed price BPA, with the option for a 6-month extension, and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor’s FSS contract. In addition, where a new FSS contract replaces Contractor’s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 1 intends to establish the base year of the agreement for the period of 11/7/2023 through 11/6/2027

5. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity; V797D-70105.

6. ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile, or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.

B. SCOPE OF PROCUREMENT:

1. FDA approved Reagents and Supplies compatible with the VA owned Roche COBAS 6800

a. The Contractor is required to provide a continuously stocked inventory of assay kits, supplies and consumables required to properly perform testing 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 assay kits and reagents.

b. The annual quantity is only an estimate. Volumes may vary during the life of the agreement.

c. Pricing to include Instrument Service, including service coverage for weekends and holidays.

d. All reagents should have the longest outdates possible, preferably 6 months before expiration when received on-site.

e. SDS – Safety Data Sheets are required. Any product formulation changes must be accompanied with an updated SDS.

f. Unexpected changes in methodology/technology shall be at the expense of the Contractor.

g. 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, lab chiefs, and the VISN 1 program office.

h. 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.

i. All pricing includes FOB destination with 2-day shipping upon order.

j. The test kits will be shipped and replenished in quantities as requested on an as-needed basis.

2. Back up instrumentation to the VA owned Roche COBAS 6800.

a. This analyzer will be acquired as a Cost per Test (CPT). Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation, and removal of equipment at no additional charge.

b. The desired instrumentation shall have the capability of performing and reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to meet 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).

c. The Contractor is required to provide a continuously stocked inventory of assay kits, supplies and consumables required to properly perform testing 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 assay kits and reagents.

d. Reagent and supplies must be compatible/interchangeable with the Roche COBAS 6800.

e. The annual quantity is only an estimate. Volumes may vary during the life of the agreement.

f. All reagents should have the longest outdates possible, preferably 6 months before expiration when received on-site.

g. SDS – Safety Data Sheets are required. Any product formulation changes must be accompanied with an updated SDS.

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

i. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations and will follow the NCL New Instrument/New Test Policy attached. These validation requirements are applicable to all new testing analyzers.

j. Unexpected changes in methodology/technology shall be at the expense of the Contractor.

k. 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, lab chiefs, and the VISN 1 program office.

l. 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.

m. Training. The Contractor shall include 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 and minimally equivalent to the terms and conditions for training defined in the Contractor’s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room, and board for each participant.

n. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation (including the Cobas 6800 that is already in place) and any incremental support/ancillary equipment, e.g., water system, printers, etc. offered according to the following terms:

i. Service Requirements

1. Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date. Maintenance will be coordinated and performed at a mutually acceptable time with the laboratory supervisor and clinically engineering staff.

2. Daily, weekly, and monthly maintenance will be performed by the end users. All other scheduled maintenance (i.e., quarterly, tri-annually, annually) will be performed by the vendor.

3. A technical assistance center shall be available by telephone 24 hours per day, 7 days per week, 365 days a year, with a maximum call back response time of 30 minutes.

4. Follow-up calls from a Field Service Engineer, when necessary, shall have a maximum call back response time of 1 hour.

5. Equipment repair service shall be provided at a mutually acceptable time coordinated with the laboratory staff. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

6. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call within 5 days. The report shall include, as a minimum, the following:

a. date and time notified

b. date and time of arrival

c. serial number, type, and model number of equipment

d. time spent for repair, and

e. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

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

o. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These upgrades will include any current/future VA mandated hardware or software requirements. 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 BPA; however, it does refer to significant changes in the hardware operational capability.

p. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate each analyzer independently as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumables, preventative maintenance and repair including, all parts, etc.), keyboard, mouse, printers 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.

q. Interface Requirements-

i. 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.

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

iii. 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.

iv. A VHA Form 6550 must be completed by the contractor and VA approved.

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

s. 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.

i. 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, thimerosal, and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

ii. Barium, Cadmium, Chromium, Copper, Cyanide, Lead, Mercury, Nickel, Silver, Zinc, Arsenic, Selenium, Tin, pH, Flash point (to higher than 200°F), BOD; biochemical oxygen demand.

iii. 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.

t. Implementation timeframe - The implementation shall be completed no later than 120 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 120-day timeframe if the extension is through no fault of the Contractor and is a result of delays due to the Government.

u. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in any proposal at an effectiveness level of 90% or more.

i. 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.

ii. 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.)

iii. 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.

iv. 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.

v. 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.

vi. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer 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. The same terms and conditions apply to ancillary/support equipment provided under this BPA, i.e., water system UPS, etc.

v. Security Requirements- The Contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing information.

w. 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.

i. 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.

ii. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.6, 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 or completion of the BPA.

iii. 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 6500.6, Electronic Media Sanitization upon: (i) completion or termination of the BPA 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 retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.6 requirements. This must be completed within 30 days of termination or completion of the BPA or disposal or return of the IT equipment, whichever is earlier.

iv. 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:

1. Contractor must accept the system without the drive.

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

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

v. 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.

1. The equipment Contractor must 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. 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 BPA.

3. 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.

Estimated Testing Volumes –

Description

Estimated Annual Qty (For both instruments)