Inactive

The West Texas VA Health Care System (WTVAHCS) in San Antonio, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or other small business sou... The West Texas VA Health Care System (WTVAHCS) in San Antonio, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), or other small business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB, or small business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON PM Central Time, March 18, 2019. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov. Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope. DISCLAIMER This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE: West Texas VA Healthcare System is in need of replacement analyzers to perform Urinalysis testing on our patient population. The vendor shall provide a Cost Per Reportable Result (CPRR) program to include the equipment, service, consumables, reagents, controls and calibrators necessary to operate system(s). This CPRR program will not include barcodes, tubes and paper. Training and associated expenses for 2 key operator(s) per instrument is included (training will be used within 12 months of instrument installation). DEFINITIONS/ACRONYMS A. CO - Contracting Officer C. Contractor and/or Supplier/Installer - Company performing work under this contract. D. NFPA - National Fire Protection Association. E. VAMC - Department of Veterans Affairs Medical Center F. VAH - Department of Veterans Affairs Hospital G. JACHO - Joint Commission on Accreditation Of Healthcare Organizations H. FSE - Field Service Engineer/Technician I. UL -Underwriters Laboratoriesft J. OSHA Occupational, Safety and Health Administration K. OEM Original Equipment Manufacturer EQUIPMENT REQUIREMENTS 1) Specifications of component equipment as set forth in this section are minimum specifications, unless otherwise stated, and shall not be construed as limiting the overall quality, quantity or performance characteristics of items furnished in the system. The Contractor Furnished Equipment (CFE) shall meet or exceed the minimum requirements and shall be held responsible for the supply, performance and overall quality of the contractor s furnished equipment. 2) All equipment to be supplied under this specification shall be the newest and the most current model of a standard product of a manufacturer of record. A manufacturer of record shall be defined as a company whose main occupation is the manufacture for sale of the items of equipment and which: a) Maintains a factory production line. b) Maintains a stock of replacement parts for the item. c) Maintains engineering drawings, specifications, operating manuals and maintenance manuals. d) Has published and distributed descriptive literature and equipment specifications on the equipment. 3) Urinalysis equipment must meet the following specifications: a) The vendor will provide each facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing. Tests shall be vendor supported. The analyzer must be able to perform all assays listed in number 18. b) Equipment shall have accurate capability of monitoring reagent usage. c) The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, UPS, interface boxes and surge suppressors. Any items excluded by the vendor shall be delineated in their technical proposal. The cost of the excluded items shall be incorporated in the quote. d) Must meet performance and characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). e) Sufficient capacity to meet the volume and service demands of a minimum of 5,000 samples per month. The analyzer must be able to perform testing on low volume specimens down to 4 mls of sample. f) Bi-directional, bar coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system/and or Cerner LIS system for real time data transmissions. Interfacing requirements to be provided by the vendor: Instrument LIS physical connection and translation (drivers). Must be compatible with Dawning Technologies system, Vista, and Cerner Information Systems. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer g) The total equipment footprint, when installed, must not negatively impact the functionality/operations of the Pathology & Laboratory Service nor will it require significant and/or costly infrastructure changes. The available space is 50 inches wide X 30 inches deep. h) Printer with capability of printing a chartable patient report with the complete patient results on a single sheet. i) Uninterruptible power supply for the analyzer. j) Automated sampling system. All analyzers must have primary tube sampling capability and be able to sample directly from aliquot containers and specimen tubes of various sizes with no sample preparation necessary. k) Analyzer shall have diluting capability with the analyzer calculating the final result. l) System shall accept urine, and other body fluids. m) System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. n) System shall have a design that removes the possibility of reagent or sample carryover, or at the very least have a mechanism in place that notifies the technician of the possible carryover. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data the instrument installed. Vendor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. System must have documented evidence that there is no reagent carryover interference with other onboard assays. o) Must process specimens through all steps so that specimen does not have to be carried by human hands between the components of the analyzer. p) The analyzers must have a comprehensive QC Program for all tests which includes at a minimum the following options: QC files with automatic calculations of mean and standard deviation of individual lots with data storage. The ability to view and print daily and monthly QC results The ability to view and print Levy Jennings graphs On-line documentation of out of range QC QC acceptance criteria built in q) Equipment shall be able to store and retransmit records (at least 24 hours of maximal instrument throughput) in case of interface downtime. Must have ability to backup and store patient data on external media. r) Must be able to perform assays listed below without manual confirmation with at least >98% of our samples. GENERAL CHEMISTRY ASSAYS Glucose Protein Bilirubin Urobilinogen pH Blood Ketones Specific Gravity Nitrite Leukocyte Esterase Color Clarity Microscopic Identifications Red Blood cells White Blood cells White Blood cell clumps Squamous Epithelial cells Renal/Transitional Epithelial cells Bacteria Mucous Sperm Crystals Yeast Hyaline casts Granular casts Cellular casts s) Vendor shall list the reagents and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution. t) Vendor shall list the reagents/waste receptacles requiring treatment before disposal. Vendor shall also list all reagents/waste that is considered above normal toxicity and/or hazard. u) Remote monitoring, maintenance and/or troubleshooting software that electronically transmits critical operational and administrative information will not be granted. INSTALLATION AND VALIDATION 1) Vendor shall move instruments, free of charge, to final testing location upon completion of validation process. 2) Vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of staff. Test counts for billing will begin after review/approval of all correlation/linearity studies performed at installation. 3) The vendor shall provide all installation/set-up and when bringing new tests on-line, a technical support specialist who shall perform all validation studies including: installation/setup, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) normal range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. This service shall be available during regular office hours (0800-1700) on a 5 days/week basis. 4) Throughout the life of the agreement, the vendor shall provide assistance to the user with setup, maintenance, and troubleshooting user-defined assays as additional tests are identified and utilized. TRAINING 1) The vendor shall provide key operator training for a minimum of two users per instrument with on-site training available to remaining users on all tours with competency assessment performed and documented. Key operator training shall be arranged by the vendor and include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. 2) Vendor shall provide/install/train users on any data management system with either off site or in-house training. 3) Vendor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals (also available on computer disk format). Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) format. SERVICE AND MAINTENANCE 1) Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm). The support service shall follow-up all down time calls within 1 hour. 2) The vendor shall provide a twenty-four hour/seven-day service hotline with technical support. 3) The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. 4) The vendor shall supply engineering controls if necessary for any heat, humidity, or noise issues that may result from use of the proposed system. 5) Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally). 6) Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level. 7) For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals INTERFACE 1) Transfer of data is bidirectional and will occur in the following manner: VISTA (LIS) INSTRUMENT DATA INNOVATIONS 2) The following data fields will be collected: Prime ID Specimen ID Patient ID Priority Action code Sample type Collect date Collect time Creation date Creation time Last name First name Middle name Sex Birthday Location Analyzer Station Test name 3) Data is transferred from VISTA to a Data Innovations Middleware (DI) device which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the DI which then sends the result back to VISTA in the appropriate format. 4) All testing is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access and verify codes. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks in locked drawers behind locked doors) per regulations. Data will be available to providers using CPRS system. 5) The above PPI will stay on the instrument s hard drive for about one month and then will be written over by new patient data. At the end of the contract the hard drive and any other data storing devices will be removed from the instrument and be taken to IRM for disposal. OTHER 1) Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the order. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria satisfactorily to the user. 2) The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. 3) The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other vendor related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. 4) In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed. 5) This order should assist the Department of Veterans Affairs to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. 6) There following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals: Benzene Carbon tetrachloride Chloroform Dichloromethane Methyl ethyl ketone Toluene Methyl isobutyl ketone Xylenes Tetrachloro-ethylene Cadmium 1,1,1-Trichloro-ethane Chromium Trichloro-ethylene Cyanide Lead Mercury Nickel COMPLIANCE WITH THE GENERAL SAFETY REGULATIONS 1) All Contractors and Subcontractors performing services for the Government shall comply with all Occupational Safety and Health Administration (OSHA), State, County and Municipal Safety and Occupational Health Standards and any other applicable rules and regulations. Also, all Contractors and Subcontractors shall be held responsible for the safety of their employees and any unsafe acts or conditions that may cause injury or damage to any persons or property within and around the work site area under this contract. 2) All ladders, scaffolding, tools, equipment, personal protective equipment, etc. shall be OSHA approved for the work to be performed. Contractor shall use caution signs as required by OSHA Regulations. Caution signs shall be on-site on commencement of Contract. 3) The Contractor shall purchase and issue all chemicals in their original containers. Materials that require precautionary warnings shall have affixed to all containers such labels or markings as are prescribed by law, regulatory agencies or this Contract. Any violation of OSHA may be subject to default action. 4) Contractor shall furnish to the COR two (2) copies of Safety Data Sheets (MSDS), for all products proposed for use, a minimum of seven (7) days prior to beginning service, for approval. Contractor must update copies of the SDS on an annual basis. In addition, each time a new chemical product is proposed to be introduced into the facility, a copy of that product's SDS must be provided to the COR for approval, prior to the product being used at the facility. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: 1) The Contractor's FSEs shall wear visible identification at all times while on the premises of the VAMC. It is the responsibility of the contractor to obtain and pay for parking. The VAMC does not provide any parking. The VAMC will not invalidate or make reimbursement for parking violations or charges for the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. 2) Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. HOURS OF OPERATION Normal hours of operations at the VAMC are Monday through Friday from 8:00 am to 4:30 pm, excluding holidays. All work will be performed during normal hours of coverage unless requested or approved by Chemistry Supervisor or his designee. Federal Holidays observed by the VAMC are: New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Independence Day Christmas Day LINE ITEM ITEM DESCRIPTION Average Use these For proposal A001 WEST TEXAS UA CHEMISTRY CPRR 16700 A002 WEST TEXAS MICROSCOPIC CPRR 8900 Estimated yearly UA and Microscopic counts for CPRR BPA Estimates based on yearly counts over the previous 3 years. Historically counts have remained consistent; however, counts may increase 1 to 3 percent over the next five years.