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TAB 1
| ATTACHMENT A | | | |
| 1) EQUIPMENT/INSTRUMENTS | | | |
| The automated blood culture instrument system shall continually monitor and promote the growth of bacterial broth cultures in aerobic and anaerobic environments. Automated loading and unloading blood culturing systems will allow for a more standardized consistency of care for the patient’s specimens. Specimens are monitored on a given frequency with updates to staff upon detecting positive and negative cultures. | | | ***Please identify where in your offer the salient characteristics are met (i.e document name, page numer, paragraph, etc.)*** |
| SALIENT CHARACTERISTICS | Meets | Does Not Meet | |
Must be a self-contained, continuous monitoring, freestanding model.
Must be a closed system and maintain a continuous temperature.
Must be 100-120V certified.
Must have the ability to provide remote support.
| Must provide additional support material that is routinely provided (i.e. CLSI documents, operators manual and validation materials). |
| Instrument system must have minimum capacity to hold/incubate 400 blood culture bottles. |
| Instrument system must be able to utilize plastic blood culture bottles. |
| Must be a computerized instrument system. |
| Must have automated monitoring of blood culture bottles with immediate, active (e.g. audible alarm) notification of microorganism growth based upon preprogrammed criteria and notification of termination of maximum programmed incubation period when no microorganism growth is detected. |
| Must have an operator extension of programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring. |
| Must include a varied selection of blood culture bottle configurations, antimicrobial agent removal resins and formulations capable of maximizing growth potential of various microorganisms (e.g. aerobic and anaerobic bacteria, yeast) shall be available. |
| Liquid media should have characteristics which support growth of microorganisms in the presence of antimicrobial agents. |
| Must provide 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 must be minimal and require a minimal handling. |
| Must provide an operational system that is automated and provides continuous unattended testing throughout the testing cycle for a minimum of five (5) days. |
| Must include a remote alarm system capable of alerting for positives in a separate workspace that are not within audible distance to the instrument alarm. Vendor to install alarm system at no cost to the government. |
| Must provide earthquake brackets at no cost to the government and assist the hospital’s structural staff with installation as needed. |
| Must provide detection of fill volume per aerobic and anaerobic bottles at the time of loading with alerts when the bottles are underfilled or overfilled (Blood volume detection is a significant variable for recovering microorganisms from patients with sepsis. Both underfilled and overfilled bottles effect the recovery of the organisms). |
| The instrument system must be capable of processing delayed entry inoculated bottles up to 24 hours, or provide appropriate data that supports the capability. |
| Must have the ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. |
| Instrument system must be able to produce blood-level reports, blood contamination, blood determination time from the embedded software. |
| Instrument system must be FDA-approved for in-vitro diagnostic use and be FDA cleared for sterile body fluids and can accommodate body fluids other than blood (synovial, pleural, peritoneal, bone marrow, etc). |
| Contractor must provide and install any and all equipment to fully operate the analyzer as defined in these specifications (e.g. cabinetry to support/house the analyzer, if necessary, UPS device(s) and universal interface equipment, etc). All ancillary components that are customarily sold or provided with the model of equipment proposed (e.g. starter kits, tables/stands, etc.) must be provided. |
Contractor must provide 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.
The accuracy of the barcode reading must be less than a 1% failure rate. Equipment shall be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment shall accept, at a minimum, 13 characters in specimen identifier that is alphanumeric.
| System must have autoloading and unloading of barcoded samples without opening the instrument door. System shall auto unload negative and positive bottles and discard them to free up additional bottle capacity. Autoloading and unloading is required to reduce hands on time and errors. |
| Contractor must provide documentation on waste characteristics. |
| Contractor must be able to deliver and install systems within 90 days of receiving a contract and systems must be validated within 15 days of installation. |
| Contractor must provide all startup reagents covering the seeded and parallel blood culture studies, and provide the protocols to perform both blood culture studies. |
| Contractor must be able to surrender the hard drive to the VA upon removal of any system. |
Instrument system must be able to interface with VISTA using an approved and released instrument manager driver.
Instrument system must be able to interface with Data Innovations Instrument Manager software using an approved and released instrument manager driver.
Instrument system must have the following features: 1) System will allow connection to solicited fully configurable interface and allow host query or bidirectional communication, 2) LIS communication ability must reside within the instruments operational software, 3) System should be able to interface at a minimum of 100 mb/s, 4) Performance must be in compliance with all applicable VA, state, federal and local laws and regulations.
Contractor supplied software must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must be within 2 lifecycles of the most recent TRM approved version. https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx
All hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network (Windows 10 and Server 2016).
Contractor must have a Memorandum of Understanding and Interconnection Security Agreement (MOU-ISA) on file with the VA, or be able to receive and maintain one during the life of this project (see Attachment B).
| Contractor must have a Business Associate Agreement (BAA) on file with the VA, or be able to receive and maintain one during the life of this project (see Attachment B). |
| Contractor must provide an blood culture instrument system training program. Training shall include the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide off-site training for two operators per facility at inception and one per year (for each year of the remaining contract) at the discretion of the VA for each model of instrumentation placed (which shall include the cost of airfare, room and board for each participant as follows: 1st off-site training prior to arrival of the instrument, 2nd off-site training after arrival of the instrument and a group training on-site in each facility. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. |
| Contractor must include a one-year warranty on new equipment. |
Instrument must fit in an area of 80" (W) x 40" (D) x 80" (H) with 2" of clearance on both sides and rear. There will be 40" of clearance to the front of the instrument.
| 2) MAINTENANCE/SERVICE AGREEMENTS | | | |
| SALIENT CHARACTERISTICS | MEETS | DOES NOT MEET | ***Please identify where in your offer the salient characteristics are met (i.e document name, page numer, paragraph, etc.)*** |
| A technical assistance center must be available by telephone 24 hours per day, seven per week, with a maximum call back response time of one hour. | | | |
| Equipment repair response time must be no more than 24 hours, a technician must be onsite within 24 hours of initial request. | | | |
| Preventative maintenance must be performed as frequently as published in manufacturer’s operators manual and within 2 weeks of the scheduled due date. | | | |
| A malfunction incident report must be furnished to the Laboratory upon completion of each repair call. | | | |
| Must provide updates to both equipment hardware and software in order to maintain the integrity of the system and state-of–the-art technology. Software upgrades must 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 and correction of hardware defect. This does not refer to replacing the original piece of equipment; however, it does refer to significant changes in the hardware operational capability. Additionally, this requirement applies to VA mandated hardware and software requirements. | | | |
| Must define daily, weekly and monthly maintenance tasks and identify which tasks are user level and service level. | | | |
| 3) PLASTIC BOTTLES | | | |
| SALIENT CHARACTERISTICS | MEETS | DOES NOT MEET | ***Please identify where in your offer the salient characteristics are met (i.e document name, page numer, paragraph, etc.)*** |
| Plastic Aerobic Bottles: The bottles must have antibiotic neutralization capabilities for antimicrobial agents for recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids. These bottles must be FDA cleared and approved for both blood and body fluid samples. | | | |
| Plastic Anaerobic Bottles: The bottles must have antibiotic neutralization capabilities for antimicrobial agents for recovery and detection of anaerobic and facultative anaerobic microorganisms from blood and other normally sterile body fluids. These bottles must be FDA cleared and approved for both blood and body fluid samples. | | | |
TAB 2
| DELIVERY LOCATIONS | ESTIMATED ANNUAL STATION VOLUMES AEROBIC/F | ESTIMATED ANNUAL STATION VOLUMES ANAEROBIC/LYTIC | QUANTITY OF INSTRUMENTS BASED ON STATION VOLUMES & INSTRUMENT WITH MIN CAPACITY OF 400 BOTTLES | UNIT PRICE | EXTENDED PRICE |
| 1) EQUIPMENT - VISN 22 WEST | | | | | |
| VA Long Beach Healthcare System | 8395 | 8395 | EA | | |
| 5901 East 7th Street | | | | | |
| Long Beach, CA 90822 | | | | | |
| VA Loma Linda Healthcare System | 6700 | 6700 | EA | | |
| 11201 Benton Street | | | | | |
| Loma Linda, CA 92357 | | | | | |
| VA San Diego Healthcare System | 9250 | 9250 | EA |
| 3350 La Jolla Village Drive | | | |
| San Diego, CA 92161 | | | |
| VA Greater Los Angeles Healthcare System | 7900 | 7900 | EA |
| 11301 Wilshire Boulevard | | | |
| Los Angeles, CA 90073 | | | |
| 1) EQUIPMENT - VISN 22 EAST | | | |
| VA Southern Arizona Health Care System | 5500 | 5500 | EA |
| 3601 South 6th Avenue | | | |
| Tucson, AZ 85723 | | | |
| VA Phoenix Health Care System | 9000 | 9000 | EA |
| 650 East Indian School Road | | | |
| Phoenix, AZ 85012 | | | |
| VA New Mexico Health Care System | 5572 | 5572 | EA |
| 1501 San Pedro SE | | | |
| Albuquerque, NM 87108 | | | |
| 2) MAINTENANCE/SERVICE - VISN 22 WEST | | | |
| Option Year # 1 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 West | | | |
| Performance period one year after delivery | | | |
| Option Year # 2 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 West | | | |
| Performance period two years after delivery | | | |
| Option Year # 3 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 West | | | |
| Performance period three years after delivery | | | |
| Option Year # 4 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 West | | | |
| Performance period four years after delivery | | | |
| 2) MAINTENANCE/SERVICE - VISN 22 EAST | | | |
| Option Year # 1 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 East | | | |
| Performance period one year after delivery | | | |
| Option Year # 2 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 East | | | |
| Performance period two years after delivery | | | |
| Option Year # 3 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 East | | | |
| Performance period three years after delivery | | | |
| Option Year # 4 - | XXXXXXXXXXXXXXXXX | XXXXXXXXXXXXXXX | EA |
| Maintenance/Service Agreements for all instruments in VISN 22 East | | | |
| Performance period four years after delivery | | | |
| 3) PLASTIC BOTTLES - VISN 22 ALL | ANNUAL VOLUMES - ALL STATIONS | CONFIGURATION - BOTTLES PER BOX | NUMBER OF BOXES BASED ON VOLUMES | UNIT PRICE | EXTENDED PRICE |
| Aerobic/F | 52,317 | | BX | | |
| Anaerobic/Lytic | 52,317 | | BX | | |
