Attachment B.docx

ATTACHMENT B – SALIENT CHARACTERISTICS

VISN 22 Infectious Molecular Pathology Equipment Purchase for WHISE Grant Funding

A. INTRODUCTION/DESCRIPTION OF REQUIREMENT

1. SCOPE OF PROCUREMENT:

1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined within this statement of work. The instrument will be able to simultaneously perform the complete profile as described below and 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).

1.2. Equipment shall maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory.

1.3. If Contractor offers a family of analyzers, VISN 22 technical evaluation panel will determine if instrumentation proposed meets needs of using facility.

1.4. Equipment shall be acquired at participating facilities within VISN 22. The following facilities currently within VISN 22, and future facilities that fall under the authority of NCO 22, may be added, or deleted to this agreement with an exercise of a supplemental agreement between the Government and the Contractor. All facilities included in VISN 22 PLMS:

1.4.1. VA Greater Los Angeles Healthcare System | 11301 Wilshire Blvd, Los Angeles, CA 90073

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

1.4.3. VA San Diego Healthcare System | 3350 La Jolla Village Dr, San Diego, CA 92161

1.4.4. VA Long Beach Healthcare System | 5901 E. 7th Street, Long Beach, CA 90822

1.4.5. VA Phoenix Healthcare System | 650 E Indian School Rd, Phoenix, AZ 85012

1.4.6. VA Prescott Healthcare System | 500 North Hwy 89, Prescott, AZ 86313

1.4.7. VA Tucson Healthcare System | 3601 S 6th Ave, Tucson, AZ 85723

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

2. DEFINITIONS:

2.1. Equipment Purchase: Acquisition of an equipment to be owned by the VA Healthcare system hospitals.

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 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. Parameter definitions –

2.3.1. High throughput molecular analyzer

B. SALIENT CHARACTERISTICS AND GENERAL REQUIREMENTS

1. TEST MENU:

1.1. The proposed equipment must be capable of performing HPV analysis and FDA cleared per grant requirements.

1.1.1. Primary screening

1.1.2. Thin-Prep Sample specimens

1.1.3. FDA approved for self-collect HPV molecular testing in a health care setting per WHISE grant funding requirements, as funding for purchase will be provided by this grant. Laboratory Developed Test (LDT) is not acceptable.

2. GENERAL REQUIREMENTS:

2.1. Technical Features - The instrumentation shall be approved by the Food and Drug Administration (FDA) and shall have the following:

2.2. Equipment must be FDA approved to meet WHISE grant requirements.

2.3. Due to limited space, instrument dimensions must fit within the following:

2.3.1. Footprint less than: 60 x 80 x 48 inches (W x H x D)

2.4. Must include all necessary software licenses for operation.

2.5. Ability to monitor instrument performance.

2.6. On board reagent inventory system.

2.7. Vendor shall have the capability to provide limited carryover.

2.8. Ready to use reagents with no mixing or preparation requirements allow Medical Laboratory Technicians in the operation and testing instead of Medical Technologists which helps relieve the impact on staffing.

2.9. No reagent calibration required.

2.10. Ability to load sufficient reagents to complete a run, with the ability to load/add reagents while the instrument is running.

2.11. On board reagent stability sufficient to accommodate both high volume (>100 per shift) and low volume (1 sample plus required controls per 24-hour period).

2.12. Reagents able to be directly loaded with tracking performed by RFID chips.

2.13. On board reagent refrigeration or temperature-controlled environment.

2.14. Walkaway time 8 hrs. when running at full capacity.

2.15. No daily maintenance.

2.16. Ability to perform partial or full runs without significant wasting of reagents.

2.17. Need to be able to create up to 3 aliquots from a single sample.

2.18. Open channel capability for the performance of laboratory developed tests.

2.19. Ability to run more than 4 different tests simultaneously.

2.20. Capability to detect out of range quality control.

2.21. Ability to automatically program the performance of QC testing.

3. HARDWARE FEATURES - Instrumentation to Include the Following:

3.1. Moderate complexity CLIA designation.

3.2. An on-board monitor/screen.

3.3. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID).

3.4. An uninterruptible power supply with line conditioner for each instrument provided.

3.5. Primary tube sampling. Option to direct load ThinPrep primary vial.

4. OPERATION The instrumentation offered shall have the following:

4.1. Direct loading of wide variety of different tube types without presorting requirements or need to sort by assay type.

4.1.1. ThinPrep vial

4.1.2. Primary tube

4.1.3. Secondary tube

4.2. Ability to view on-board reagent and consumable inventory.

4.3. Minimum of up to three freeze/thaw cycles when stored frozen at ≤18C for repeats, new lot comparisons, method comparisons.

4.4. Must have a visual notification of instrument status (example i.e., if supplies are missing, if immediate action is required to avoid sample loss, or if an instrument hardware error has occurred).

4.5. Instrument must have both built in physical and chemical contamination control measures.

4.6. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment shall be minimal and require a minimum amount of handling.

4.7. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

4.7.1. The accuracy of the barcode reading shall have less than a 1% failure rate.

4.7.2. Equipment shall be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

4.7.3. Equipment shall accept, at a minimum, 13 characters in specimen identifier that is alphanumeric.

4.7.4. to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

5. SUPPORT FEATURES:

5.1. Commercial marketing. The equipment models being offered shall be in current production and FDA cleared for self-collect HPV testing, as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

5.2. Training. 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. 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 two (2) operators per facility per year at the discretion of the VA 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. Contractor may offer two (2) classroom training slots for each participating VA location (base year only) in lieu of in-depth on-site or virtual training, for which the Contractor shall cover the cost of airfare, room and board for each participant traveling off-site. Follow up to classroom training in the base year and any subsequent option years (if requested) will occur on-site with a Field Application Specialist (FAS) in a train-the-trainer model (minimum 2 operators per facility) or virtual training. Training paths may be unique to each VA location.

6. INTERFACE REQUIREMENTS:

6.1. Contractor shall have and maintain a current Memorandum of Understanding/Information Security Agreement (MOU/ISA) with the VA to provide remote support assistance, diagnostics and systems monitoring capabilities. Vendors not having a current agreement shall agree to completing an MOU/ISA for this purpose at the vendor’s expense.

6.2. 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.

6.3. 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. Information necessary to make the determination for type and amount of interfacing equipment is supplied.

6.4. 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.

6.5. The vendor hardware and software proposed solution meets all VA Information Security, Hardware, Software and Network requirements (VA 6500)

6.6. 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.

6.7. 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.

6.8. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed 90 days for the transition of all services under the awarded requirement including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the requirement.

7. STANDARD AND QUALITY OF PERFORMANCE

7.1. This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the requirement 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 requirement at an effectiveness level of 90% or more.

7.2. 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.

7.3. 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.)

7.4. 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.

7.5. 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.

7.6. 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.

7.7. 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 POC 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.

7.8. 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.

7.9. Ownership of Equipment – This will be a purchase requirement in which the equipment will be owned by the VA healthcare system hospitals.

7.10. 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.

7.11. Prior to termination or completion of this requirement, Contractor/subcontractor shall not destroy information received from VA, or gathered/created by the Contractor in the course of performing this requirement 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 requirement.

7.12. 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 requirement 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 requirement or disposal or return of the IT equipment, whichever is earlier.

7.13. 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:

7.14. Contractor shall accept the system without the drive.

7.15. 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

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

7.17. 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; 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 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 contract.

7.18. 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.

7.19. VA Information and Information System Security / Privacy.