SPECIAL NOTICE
Q -- Amarillo Lab Biomerieux (BioFire) Supplies
- Notice Date
- 6/12/2024 12:15:44 PM
- Notice Type
- Special Notice
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25724Q0723
- Response Due
- 6/19/2024 12:00:00 PM
- Archive Date
- 06/26/2024
- Point of Contact
- Joshua Weisman, Contract Specialist, Phone: (432) 213-7094
- E-Mail Address
-
joshua.weisman@va.gov
(joshua.weisman@va.gov)
- Awardee
- null
- Description
- AMARILLO VA HEALTH CARE SYSTEM PATHOLGOY AND LABORATORY MEDICINE SERVICE BIOFIRE CONUSMABLES, SUPPLIES, REAGENTS AND SERVICE STATEMENT OF WORK (SOW) A. SCOPE The Amarillo VA Health Care System (AVAHCS) has a need for a Firm Fixed Price, Indefinite Delivery/Indefinite Quantity (IDIQ) contract for brand name reagent kits compatible with the government owned Bio Fire Film Array TORCH 4 instrumentation in the Microbiology Laboratory of Pathology & Laboratory Medicine Service at Thomas E. Creek VA Hospital in Amarillo, TX 79106 and government owned Bio Fire Film Array TORCH 2 instrumentation at the Lubbock Community Based Outpatient Clinic, Lubbock, TX 79145. These reagents/supplies/consumables must be FDA Approved for Film Array Panel testing for a comprehensive set of pathogens. These panels aid in quickly identifying the correct pathogen and ensure appropriate treatment, patient management and help decrease infectious diseases which can lead to severe illness or death. B. VENDOR RESPONSIBILITIES 1. The Vendor shall provide, in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, reagents/supplies/consumables/service negotiated on GSA contracts to enable AVAHCS to accurately and efficiently process microbiology identification of patient samples using the Film Array TORCH 4 among a list of bacteria and viruses as required by sample submitted. 2. The Vendor shall provide the ability to automatically ship reagents monthly to the Amarillo VAHCS. 3. The Vendor shall provide the ability to ship reagents on an As Needed basis to the Amarillo VAHCS. 4. The vendor shall ship all the reagents/supplies/consumables as noted in Attachment A. to: (a) Amarillo VA Health Care System (b) Lubbock CBOC 6010 Amarillo Blvd., West 3510 4th St. Amarillo, TX 79106 Lubbock, TX 79145 Attention: Laboratory Attention: Laboratory 5. The following laboratory personnel shall be granted responsibility to order supplies, reagents, consumables, service, repair, and maintenance on behalf of the COR. The AMA Microbiology Technical Specialist and/or AMA or LUB Laboratory Manager(s) so long as they can provide the current PO number. 6. The Vendor shall provide the facility with the most current Food and Drug Administration (FDA) approved reagents/supplies/consumables necessary for the microbiology testing of patient samples for the identification of bacteria and viruses. 7. The kits must be compatible with the Bio Fire Film Array TORCH 4 and TORCH 2 system base box MPN HTFA-ASY-0001 and the Bio Fire Film Array TORCH Duplex box MPN HFTA ASY-0002 for both AMA and LUB Microbiology labs. 8. The Vendor must acknowledge receipt of order within 24 hours and provided estimated shipping timeframe. 9. The Vendor must be able to provide an as needed continuous stock of inventory of the below listed reagents. 10. The Vendor must be able to provide an Emergency plan in case reagents are found to be defective and unsuitable for use at no additional cost. a. 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 they have failed to comply with the requirements for routine supply delivery, the vendor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. b. 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 as required to allow operations of the Microbiology Laboratory equipment for one week (under normal Government test load volume) so testing is not delayed. If additional requests for emergency supply delivery is 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. c. The vendor shall reimburse the facility for the total reference laboratory 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 or any other product issues. The assessed damages shall be applied to the invoice in the form of a credit or deduction. 11. All requirements and provisions defined in the specification of this solicitation will apply to any vendor, i.e., branch, division, sub-Vendor, etc. supplying parts or reagents on behalf of the Vendor. 12. The kits must be maintained and delivered following all Federal and State regulations as applicable. 13. The Vendor shall encompass all costs associated to perform quality control, calibration and correlation study testing that is prescribed by National Committee for Clinical Laboratory Standards (NCCLS). 14. The Vendor shall provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. The system must have documented evidence that there is no reagent carryover interference with other onboard assays. 15. The Vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. 16. The Vendor shall supply information regarding any hazardous chemicals. 17. The Vendor shall list the reagents, controls, and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution. 20. The Vendor shall list the reagents/waste receptacles requiring treatment before disposal. 21. The Vendor shall also list all reagents/waste that is considered above normal toxicity and/or hazard. 22. The Vendor shall not (at this time) include remotely monitored maintenance or troubleshooting software programs that electronically transmits critical operational and administrative information from instruments to our internal systems via a secure Internet connection. This option may be added at a later date. This secure, encrypted technology will enable transfer of key logs, report generation, and remote services developments. It should also offer the potential to improve inventory management by enhanced troubleshooting information made available to a technical support group, a portal to access instrument logs, files, maintenance information, software version, proactive instrument operations monitoring, predictive instrument maintenance, and QC data collection for peer review. 23. The Vendor shall provide, at no cost to the Government, at installation/set-up and/or when bringing new tests online, a technical support specialist who shall perform all validations studies including: a. Start-Up Reagents 1). The Vendor shall provide all reagents, calibrators, controls, linearity material, consumable/disposable items, parts, accessories, and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish equipment/analyzers for operation, for performance of acceptance testing at no additional charge to the Government. 2). This applies to all equipment/analyzers as well as additional or replacement equipment/analyzers placed under the terms and conditions of the contract. 24. General Duties, Requirements, and Expectations: a. Be professionally competent to handle required duties. b. Work with staff to ensure safety measures are in place and documented. c. Services provided under the terms of this contract are required to be in compliance with the manufacturer daily, weekly, monthly, and as needed maintenance after the 1 year warranty has expired. C. PERIOD OF PERFORMANCE 1. Five one-year ordering periods (60 months). D. BILLING 1. The Vendor shall submit all invoices in arrears. 2. Invoices shall be submitted electronically through to OB10 website: http://www.ov10.com/us/en/#&panel1-1. 3. Payment will be made by VA FSC, Austin, Texas 30 days after receipt of a proper invoice. 4. General information to include on invoices: a. Submission of a proper invoice including facility name, address, and phone number. b. Type of reagent/service performed. c. Quantity d. Date(s) of service or Period of Performance e. Purchase Order number f. Price g. Invoices can be refused if any of the information in section D.4. a-f is missing. h. Both AMA and LUB laboratories will be using the same PO number, but for each location a new a separate invoice shall be required. Payment for both AMA and LUB laboratories invoices will be the responsibility of the AMA COR. E. SITE VISIT 1. Site-visits shall not be scheduled or conducted without the coordination of the Contract Specialist and/or Contracting Officer Representative (COR). 2. Contact the Contract Specialist and/or Contracting Officer Representative (COR).for more information. F. NORMAL WORKING HOURS & ACCESS TO SITE The Vendor Repair Service Technician shall check-in with the AVAHCS Police Service before proceeding to the Laboratory Department. This check-in is mandatory. The Vendor shall schedule on-site services with the COR during normal working hours between Monday and Friday, 8:00 a.m. and 5:00 p.m., local time, excluding Federal Holidays. Work outside of Normal Business Hours is not authorized. Legal Holidays Observed: a. New Year s Day Martin Luther King President s Day Memorial Day Independence Day Juneteenth Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day b. Please note that holidays falling on Saturday will be observed on the preceding Friday; holidays falling on Sunday will be observed on the following Monday. G. INTERFACE 1. Transfer of data is bidirectional and will occur in the following manner: VISTA (LIS) DATA INNOVATIONS INSTRUMENT 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 Secure Network Interface (SNI) device, which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the SNI which then sends the result back to VISTA in the appropriate format. 4. Patient testing is performed by Amarillo VAHCS Respiratory department staff and the Pathology & Laboratory Medicine Service staff using appropriate procedures, to access and verify codes. 5. 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. 6. The above Protected Patient Information (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. H. 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 contract. 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 other analyzer(s) that can produce the required criteria satisfactorily to the user. 2. Vendor shall notify the Bio-Medical department for removal the hard drive on any trade in analyzers and turning it over to the VA for destruction prior to removal of any analyzer. 3. 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 4. This contract should assist the Amarillo VA Health Care System to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. The 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 Chloroform Methyl ethyl ketone Methyl isobutyl ketone Tetrachloro-ethylene 1,1,1-Trichloro-ethane Trichloro-ethylene Lead Nickel Carbon tetrachloride Dischloromethane Toluene Xylenes Cadmium Chromium Cyanide Mercury I. PRIVACY / SECURITY OF VA SENSITIVE INFORMATION 1. The Vendor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. 2. The Vendor will not have access to Patient Health Information (PHI), nor will they have the capability of accessing patient information during the services provided to the VA. 3. There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.]. 4. The C&A requirements do not apply, and that a Security, Accreditation Package is not required. 5. The Vendor shall not have access to VA Desktop computers, nor will they have access to online resources belonging to the Government while conducting services. If removal of equipment from the VA is required, any memory storage device, such as hard drives, solid state drives and non- volatile memory units will remain in the VA control and will not be removed from the VA custody. 6. Upon completion or termination of the contract, the Vendor shall either provide all copies of all VA information to the VA or certify that has destroyed all copies of all VA information as required by VA in a method specified by VA, at VA s option. a. Medical records of any kind including notes shall be returned to the VA. b. Where immediate return or destruction of the information is not practicable, the Vendor will return or destroy the information within 30 days of completion or termination of the contract. c. All provisions of this contract concerning security and protection of VA information that is the subject of this contract will continue to apply to information for as long the Vendor retains it, regardless of whether the contract has been completed or terminated. 7. Prior to any disclosure pursuant to a court order, the Vendor shall promptly notify VA of the court order upon its receipt by the Vendor, provide VA with a copy by fax or email, whichever is faster, and notify by telephone the VA individual designated in advance to receive such notices. a. If the Vendor cannot notify VA before being compelled to produce information under court order, the Vendor will notify VA of the disclosure as soon as practical and provide a copy of the court order, including a copy of the court order, a description of the records provided pursuant to the court order, and to whom the Vendor provided the records under the court orders. b. If the VA determines that it is appropriate to seek retrieval of information released pursuant to a court order before the Vendor notified the VA of the court order, the Vendor shall assist VA in attempting to retrieve the VA information involved. 8. All Vendor employees and all subcontractor employees are subject to the same level of investigation as VA employees who have access to VA sensitive information. The level of background investigation commensurate with the level of access needed to perform the Statement of Work (SOW). a. The Vendor shall bear the expense of obtaining background investigations. b. If the investigation is conducted by the Office of Personnel management (OPM) the Vendor shall reimburse the VA within 30 days from receipt of a bill of collection. c. The Vendor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and area able to read, write, speak and understand the English language. ATTACHMENT A. Item # Description/Part Number* Estimated Annual Minimum Qty/kit 423640 BCID Verification Kit 1 FLM1-ASY-0130 GI VERIFICATION KIT 1 FLM1-ASY-0145 ME VERIFICATION KIT 0 RFIT-ASY-0116 KIT, FILMARRAY GI PANEL, 30 TESTS/kit 25 RFIT-ASY-0118 KIT, FILMARRAY ME PANEL, 30 TESTS/kit 0 RFIT-ASY-0144 KIT, FILMARRAY PNEUMO PANEL, 30 TESTS 10 RFIT-ASY-0147 KIT, BIOFIRE BCID PANEL,30 TESTS 10 423742 KIT, BIOFIRE RP2.1 PANEL, 30 TESTS 70
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