SOURCES SOUGHT
66 -- Cost-per-Test Blood Gas Analyzers
- Notice Date
- 1/24/2019
- Notice Type
- Synopsis
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 22;4811 Airport Plaza Drive;Suite 600;Long Beach CA 90815
- ZIP Code
- 90815
- Solicitation Number
- 36C26219Q0319
- Response Due
- 1/30/2019
- Archive Date
- 3/1/2019
- Point of Contact
- Contract Specialist
- Small Business Set-Aside
- N/A
- Description
- THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), 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 RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 334516 (size standard of 500 Employees). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can at a minimum meet the following statement of work with a brand name or equal product and service for Cost-Per-Test (CPT) Blood Gas Analyzers for the VA New Mexico Healthcare System and the Greater Los Angeles Healthcare System: VISN 22 Medical Centers New Mexico VA Healthcare System VA Greater Los Angeles Healthcare System Base year plus an additional 4 one-year options period: May 1, 2019 through April 30, 2024 SCOPE: New Mexico VA Health Care System (NMVAHCS) and VA Greater Los Angeles Healthcare Systems (VAGLAHS) require a cost-per-test blood gas system that performs a comprehensive panel of pH, blood gas, oximetry, electrolyte and metabolite testing. The system must be FDA approved to perform pH testing of pleural fluids. The intent of the Pathology & Laboratory Medicine Service (P&LMS) is to provide continuous, accurate results in the management of respiratory and metabolic disorders. The lactate result may be used as part of an initial evaluation of someone who is suspected of having sepsis. In a person being treated for an acute condition, such as sepsis, shock or heart attack or a chronic condition, such as severe congestive heart failure, lactate levels may be ordered at intervals to help monitor hypoxia and response to treatment. The desired proposal (analyzers, reagents, quality control materials, service and maintenance agreement, and training) will be on a cost-per-test basis. Should include additional pricing sheet for additional required supplies needed. The length of the contract would be for the base year (during the validation process and possible patient testing if the analyzers pass validations) and four subsequent optional years of patient testing. Current approximate annual testing volumes for New Mexico VA Healthcare System: 4,898 Lactic acid tests 731 Ionized calcium tests 1733 Arterial blood gases/co-oximetry *NMVAHCS would like the option to add an IDMS creatinine to support the needs of our emergency room (estimated yearly volume unavailable at this time) Current approximate annual testing volumes for VA Greater Los Angeles Healthcare System: 11,485 Lactic Acid 9,632 Ionized Calcium 7624 Arterial Blood Gasses/Co-oximetry Prior to solicitation, NMVAHCS and VAGLAHS, P&LMS may request a visual demonstration of each vendor s instrument (whether on a mobile unit, a visit to a local laboratory or via a video). A portion of the final evaluation will be based upon the information obtained during this visual demonstration. At a minimum, the vendor must be able to supply equipment/software to meet the following requirements: GENERAL REQUIREMENTS The vendor shall provide the most current FDA approved Blood Gas platform available. The parameters that must be offered are pH (arterial and venous blood and pleural fluid), pCO2, pO2, ionized calcium, lactate, IDMS Creatinine, and oximetry (sO2, O2 Hgb, CO Hgb, and MetHgb). The vendor will provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing. There should be a redundancy in instrumentation so as that there is always an analyzer available (24/7) for patient testing due to the critical nature of the need for rapid patient results. 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, and surge suppressors. Also, to include any engineering controls necessary to maintain proper drainage, operating temperature (minimizing impact of heat and humidity), and minimizing noise levels. Any items excluded by the vendor shall be delineated in their technical proposal. The cost of the excluded items shall be incorporated in the price proposal. EQUIPMENT FUNCTIONALITY All analyzers must have primary whole blood tube/syringe sampling capability. The analyzers must have an on-board Quality Control Program or supporting software that provides the ability to monitor QC. System shall have a design that removes or mitigates the possibility of reagent or sample carryover. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed. System shall have positive sample identification via barcode to reduce possible sources of error/delay. Analyzer reports shall have at a minimum two patient identifiers (i.e. Patient Name, Specimen ID). Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime. Interfacing requirements to be provided by the vendor: Instrument LIS physical connection and translation (drivers). Must be compatible with Data Innovations system. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer Vendor shall list the reagents and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution. INSTALLATION AND VALIDATION Vendor shall move instruments, free of charge, to final testing location upon completion of validation process. 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. At installation/set-up, a technical support specialist shall assist with all validation studies including: installation/set-up, 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 on a 5 days/week basis. Throughout the life of the agreement, the vendor shall provide assistance to the user for all maintenance and troubleshooting issues and additional testing as needed. TRAINING The vendor shall provide comprehensive primary user training for a minimum of two users per instrument and training available to remaining users with competency assessment performed and documented. Vendor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals (also available in editable electronic format). Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) format. SERVICE AND MAINTENANCE 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. If both analyzers become inoperable service support and on-site service will be available 24/7. The vendor shall provide a service report within 72 hours of all preventative maintenance and service repair performed by the vendor. The vendor shall provide a service hotline with technical support. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. 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). 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. 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. OTHER 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 another analyzer(s) that can produce the required criteria satisfactorily to the user. 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 and onsite user training. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. 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, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. In the event 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. This contract should assist the NMVAHCS and VAGLAHS to pursue the goal of being good stewards 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 Carbon tetrachloride Chloroform Dischloromethane Methyl ethyl ketone Toluene Methyl isobutyl ketone Xylenes Tetrachloro-ethylene Cadmium 1,1,1-Trichloro-ethane Chromium Trichloro-ethylene Cyanid Lead Mercury Nickel INFORMATION SECURITY REQUIREMENTS The C&A requirements do not apply and a Security Accreditation Package is not required. The Contractor is subject to the provisions of the Health Insurance Portability and Accountability Act (HIPAA), the Privacy Act of 1974, as well as all applicable VA laws and regulations. The Contractor shall keep confident the contents of all medical documents entrusted to its care. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. The Contractor shall immediately notify the VA Healthcare Systems (VAHCS) Contracting Officer and the VAHCS Information Security Officer of any actual or suspected loss, release or compromise of any VHACS document or electronic information under its control. Any breach must be reported within one hour which is in accordance with the following: VA 6500 Handbook page 56: (b) Procedure: Users will immediately report any incident of theft, loss, or compromise of VA sensitive information or information systems to the ISO and/or PO and supervisor. VA 6500 Handbook page 65: (4) (r) VA employees, contractors, subcontractors, and volunteers must immediately report to his or her VA supervisor and the local ISO any incident of theft, loss, or compromise of any VA sensitive information, VA equipment or device, or any non-VA equipment or device used to transport, access, or store VA information. The ISO will promptly report the incident (within one hour) to the VA-NSOC in accordance with the OI&T Incident Management procedures. 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 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract 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 returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. 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 vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; (2) VA s initial medical device purchase 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. (4) 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; (a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and (b) 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 preapproved and described in the purchase order or contract. (c) 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 ISO needs to maintain the documentation. Figure 1 BAA RADIOMETER CONTRACTOR TRAINING If contractor employees and subcontractor employees require access to VA information and VA information systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training. (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access. National Rules of Behav. Contractor Rules of Behav Mandatory TMS Train RECORDS MANAGEMENT The contractor shall be responsible for creating, maintaining and disposing of only those Government required records. If requested by the NMVAHCS COR, the contractor shall provide the original record, or a reproducible copy of any such record, within two (2) business days of receipt of the request. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI) N/A Other Pertinent Information or Special Considerations None Place of Performance New Mexico VA Healthcare Systems (NMVAHCS) Pathology and Laboratory Medicine Service (113) 1501 San Pedro SE Albuquerque, NM 87108 VA Greater Los Angeles Healthcare Systems (VAGLAHS) Pathology and Laboratory Medicine Service 11301 Wilshire Blvd Los Angeles, CA 90073 Period of Performance Base Year: 5/1/2019 through 4/30/2020 Option Year 1: 5/1/2020 through 4/30/2021 Option Year 2: 5/1/2021 through 4/30/2022 Option Year 3: 5/1/2022 through 4/30/2023 Option Year 4: 5/1/2023 through 4/30/2024 Brand Name Information: Line Item Item Number Description QTY UNIT 1 N/A BASE YEAR: 05-01-2019 through 04-30-2020 Cost-per-test Blood Gas Analyzers ABL827 to include (2) instruments, consumables, and services. 12 MO 2 N/A OPTION YEAR 1: 05-01-2020 through 04-30-2021 Cost-per-test Blood Gas Analyzers ABL827 to include (2) instruments, consumables, and services. 12 MO 3 N/A OPTION YEAR 2: 05-01-2021 through 04-30-2022 Cost-per-test Blood Gas Analyzers ABL827 to include (2) instruments, consumables, and services. 12 MO 4 N/A OPTION YEAR 3: 05-01-2022 through 04-30-2023 Cost-per-test Blood Gas Analyzers ABL827 to include (2) instruments, consumables, and services. 12 MO 5 N/A OPTION YEAR 3: 05-01-2023 through 04-30-2024 Cost-per-test Blood Gas Analyzers ABL827 to include (2) instruments, consumables, and services. 12 MO The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested and capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (6) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract number. (7) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (8) Please provide general pricing of your products/solution for market research purposes. (9) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? (10) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. (11) Please provide your DUNS number. *** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items" meet all the salient characteristics. Responses to this notice shall be submitted via email to Carol.Evans3@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Wednesday January 30, 2019 at 5:00 p.m. PST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (24-JAN-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
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