Amendment 0001 Attachment - Questions and Answers.xlsx
XLSX spreadsheet 24 KB Posted
- Attached to
- Nationwide Infusion Pump Requirement Federal contract opportunity
- Solicitation number
- 36C24125R0070_1
About this file
This file is an Amendment 0001 Questions and Answers document for a VA solicitation for Nationwide Infusion Pump Requirements (Solicitation #36C24125R0070_1). The procurement seeks to acquire infusion equipment across the VA enterprise, including large volume pumps (LVP), syringe pumps, and patient controlled analgesia (PCA) pumps and associated software. The solicitation is unrestricted, with a NAICS code of 339112 and a small business size standard of 1,000 employees. Key technical requirements include FDA-approved devices with wireless communication capabilities, operating on currently supported operating systems, FIPS 140-2 or 140-3 certified wireless networking, and compatibility with Oracle Health's CareAware Platform.
The contract will be an Indefinite Delivery/Indefinite Quantity (IDIQ) with a five-year ordering period from October 1, 2025, to September 30, 2030, with a total maximum quantity of $100 million. Offerors must provide detailed technical specifications, including operating manuals, device specifications, configuration options, cleaning instructions, and maintenance guides. The VA will evaluate proposals based on technical acceptability, with fair opportunity competition for subsequent delivery orders. Potential offerors were required to submit questions by 10:00 AM EST on May 14th, 2025, with responses provided through amendments. The solicitation emphasizes ongoing support, including parts availability, vulnerability fixes, and upgrades for the useful life of the devices.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 36C24125R0070 0003.docx | DOCX document | |
| Amendment 0003 Attachment - Questions and Answers.xlsx | XLSX spreadsheet | |
| 36C24125R0070 0002.pdf | ||
| Amendment 0001 Attachment - Revised FAR 52.212-1 Instructions to Offerors.pdf | ||
| Amendment 0001 Attachment - Revised FAR 52.212-2 Evaluation.pdf | ||
| 36C24125R0070 0001.pdf | ||
| Amendment 0001 Attachment - Revised Statement of Work.pdf | ||
| Solicitation Attachment A - Pricing Worksheet.xlsx | XLSX spreadsheet | |
| Solicitation Attachment C - VA Directive 6550 Appendix A.pdf | ||
| Solicitation Attachment B - NEMA MDS2 Worksheet.xlsx | XLSX spreadsheet | |
| 36C24125R0070.pdf |
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| ID | Paragraph (reference Combined Synopsis/Solicitation, SOW, or Attachments) | Page Number | Section Title | Paragraph Number | Offeror's Questions | Government Response |
| 1 | Solicitation Attachment C - VA Directive 6550 Appendix A | 1 | With respect to Question 1.17 of Solicitation Attachment C, VA 6550, Appendix A – i.e., “If no, does the vendor support the installation of FIPS 140-2 or 140-3 wireless cards?”, please explain how this clause will be used and applied for Infusion Pump FDA Class II performance standards? | The status of the FIPS 140-2 or 140-3 certification number provided in the 6550 Appendix A field 1.17 will be verified on the National Institute of Standards and Technology (NIST) website. It is the responsibility of the manufacturer to comply with FDA regulations in determining if a new 510(k) is required any time changes are made to a medical device. | ||
| 2 | Solicitation Attachment C - VA Directive 6550 Appendix A | 1 | With respect to Question 1.17 of Solicitation Attachment C, VA 6550, Appendix A – i.e., “If yes, what is the FIPS 140-2 or 140-3 certification number?”, will the offered Infusion Pump devices requiring wireless connection require a “device” NIST FIPS certificate? | Devices using 802.11 wireless networking require a FIPS certification number at either the device or wireless card level. If vendors are in-progress with achieving FIPS compliance and provide evidence in the IDIQ submission, the requirement is partially met. In order to fully meet this requirement and be eligible to potentially receive a delivery order award, FIPS 140-2 or 140-3 certification at the device or wireless card level is required. | ||
| 3 | Combined Synopsis/Solicitation | 6 | B.1 Contract Administration Data | Section B.1 of the solicitation states “the total maximum quantity of supplies and services that the Government can order under each IDIQ contract will not exceed $100M.” solicitation at page 6. Given that this is an enterprise-wide contract with a five-year ordering period, the useful life of some pumps, and existing recalls, this does not appear to be a sufficiently large ceiling amount for a complete fleet replacement. How did the VA arrive at this limit? Will the VA consider increasing the limit? | An independent government cost estimate was developed based on the agency's expected needs over the next five years considering which VA faciliites will require fleet replacements, the useful life of available products in the market, and possible expansions at facilities during the ordering period. VA believes no updates are necessary. | |
| 4 | SOW | 7 | B.1 Large Volume, Syringe and PCA Pumps | Section B.1.1 of the Technical Requirements states “the pump shall be FDA approved.” solicitation at page 7. How will the FDA ensure compliance with this requirement over the course of the contract? For example, if an offeror makes any material changes to its proposed pumps during the contract term – including, but not limited to, changes to the proposed pumps’ Operating System – governing regulations require the offeror to obtain a new FDA 510K clearance for its pumps. How will the VA ensure that the awardee will obtain new FDA 510(K) clearances when required, and provide “FDA approved” pumps over the life of the contract? Will the VA prohibit offerors from making change to pumps that could jeopardize the FDA clearance that applies to an offeror’s pumps at the time of award? | The FDA has quality and compliance programs that ensure medical devices in the United States remain safe and effective throughout their lifecycle. Regulations address complaint investigations and other post-market surveillance performance. It is the manufacturer’s responsibility to maintain regulatory compliance and notify VA if at any point there are barriers to meeting this requirement (before procurement and while in use). Any changes may require an updated or new VA Directive 6550 Appendix A to be submitted. | |
| 5 | SOW | 7 | B.1 Large Volume, Syringe and PCA Pumps | Section B.1.2 states “parts, consumables, and product support shall be available for the useful life of the device. Section B.1.3 states “remediation, vulnerability fixes, and upgrade services pertaining to recalls and medical device correction notices shall be available at no-cost to VA for the useful life of the device.” Assuming the Infusion System and device is not discontinued for patient safety by FDA recall, is there a minimum period a device purchased 30 September 2030 must be supported to help define useful life of the device? Can a device be end of sale by the manufacturer before 30 September 2030? | Useful life, synonymous with service life, is defined as the time that a device is expected to remain functional and supported by the manufacturer after placed into use. This period of time is defined by the manufacturer. The manufacturer is responsible for end of sale dates. It is not in the best interest of the government to procure medical devices with a known end of sale or end of service life that will occur before the end of the estimated useful life. | |
| 6 | SOW | 7 | B.1 Large Volume, Syringe and PCA Pumps | Section B.1.3 states “remediation, vulnerability fixes, and upgrade services, pertaining to recalls and medical device correction notices shall be available at no-cost to VA for the useful life of the device.” See solicitation at page 7. How will the VA, a VISN, or a VA facility, address existing recalls when evaluating proposals and selecting awardees at the IDIQ contract level? How will the VA address subsequent recalls? For example, how will the VA, a VISN or a VA facility address recalls when deciding what equipment can be ordered under an IDIQ TO/PO? Will the VISNS, or other VA activities, be permitted to order pumps that become subject to a recall after the award of the IDIQ contracts? | VA will follow recall guidance published by the manufacturer and FDA. If, at any point, a medical device on the IDIQ contract is recommended to be removed from use with no available remediation, the manufacturer shall notify the Contracting Officer immediately. Appropriate steps will be taken to remove the impacted device from contract. The severity of recalls can vary and will be handled accordingly with the manufacturer. | |
| 7 | SOW | 7 | A. Requirement Overview | 2 | Section B.2.A requires integration with the Electronic Health Record (“EHR”) system at each VA facility or VISN. See solicitation at page 7 (“the contractor shall provide technical support for the installation of each device as well as integration with the quality improvement, medication management, reporting infrastructure and Electronic Health Record (EHR) system at each VA facility (or VISN, if applicable)”). However, the solicitation is silent about VA sites using legacy VistA EHR. Does the VA expect or require that infusion devices integrate with VistA? | VistA and Computerized Patient Record System (CPRS) integration is not a requirement. The solicitation has been revised accordingly, as needed. |
| 8 | SOW | 8 | B.3 Syringe Pump | The solicitations requires the use of Oracle. Specifically, section B.3.5 states “the pump shall be validated by Oracle Health’s CareAware Platform to support medical device integration.” Solicitation at page 8; see id. at page 13 (requiring offerors to provide “evidence of Oracle Health’s CareAware Platform validation for specified device eval workflows and infusion management solutions, including successful bidirectional communications”); id. at page 44 (requiring “evidence of validation by Oracle Health’s CareAware Platform to support medical device integration for applicable pumps”). Is this a realistic requirement given that: (1) it will be years before all VAMCs are using Oracle; and (2) based on EHRM delays and implementation challenges, Oracle will not be fully operational in 5 years? | The complete deployment of the Federal EHR system at all VA medical centers is estimated as early as 2031. The applicable infusion pumps shall be validated by Oracle Health’s CareAware Platform to support medical device integration. Validation status will be evaluated upon receipt of responses to each fair opportunity solicitation. Validation of Oracle Health CareAware Platform is required regardless of whether the VA facility purchasing the devices is or is not using Oracle at the time of responding to the fair opportunity solicitation. | |
| 9 | SOW | 7 | B.1 Large Volume, Syringe and PCA Pumps | Section B.1.2 states “parts, consumables, and product support shall be available for the useful life of the device.” See solicitation at page 7. Can the VA please define the “useful life” of a device? For example, is “useful life” determined by the OEM or VA? Failure to define this term could allow manufacturers to discontinue offering a device - as well as its software, components, support, and training - within a few years of award, on grounds that the device’s useful life has expired. Lack of an express definition could also allow certain VA sites to redefine the term in such a manner that enables them to refuse to replace the pumps they are using and potentially jeopardize integration with other devices and the larger VA network. | Useful life, synonymous with service life, is defined as the time that a device is expected to remain functional and supported by the manufacturer after placed into use. This period of time is defined by the manufacturer. | |
| 10 | Combined Synopsis/Solicitation | When read together, the solicitation provisions regarding the useful life of pumps and devices, and those requiring supported operating systems create some ambiguity that requires some clarification. |
Sections B.1.2 and B.1.3 reference the “useful life” of pumps and devices. See solicitation § B.1.2 at page 7 (“parts, consumables, and product support shall be available for the useful life of the device”); solicitation § B.1.3 (“Remediation, vulnerability fixes, and upgrade services pertaining to recalls and medical device correction notices shall be available at no-cost to VA for the useful life of the device”).
Section D and solicitation Attachment C address Operating Systems. Section D.3.1 states “the infusion pumps shall run on an operating system currently supported by the operating system manufacturer.” Section 1.16 of solicitation Attachment C, VA 6550 Appendix A, prohibits the procurement of devices with “unsupported operating systems,” which are defined as “OSs that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e. no further security patches will be released for the OS by the manufacturer after the OS end-of-life nor will be available by other methods such as extended warranty purchases from the OS manufacturer).”
Windows Server 2019 officially ended mainstream support. While Microsoft will continue to provide security updates until January 9, 2029, the operating system is not receiving new features or bug fixes. SQL Server 2019 and earlier ended mainstream support and extended end date is January 8, 2030. In light of the foregoing solicitation provisions, this raises the following question:
| a. Can the VA clarify the useful life of pumps and devices running on Windows Server or SQL Server 2019? | The useful life is defined by the manufacturer. Currently Microsoft Server (MS) 2019 Long Term Servicing Channel (LTSC) is in the security support period until 1/9/2029. Once an Operating System (OS) and SQL database server becomes unsupported (and cannot be patched), it presents a higher risk and is therefore prohibited to be procured. This is in accordance with VA Directive 6550. | |||
| 11 | Combined Synopsis/Solicitation | In reference to ID 10 above, can the VA clarify the minimum Microsoft Server year/version the VA will accept for 510(K) device offerings for this submission? | The timelines for Active Support, Security Support and Extended Security Updates vary by release. For all releases of Microsoft OS, the VA will only procure new systems running an actively supported or security supported OS. | |
| 12 | Combined Synopsis/Solicitation | In reference to ID 10 above, would an infusion pump or device running Windows Server or SQL Server 2019 meet the requirement of section D.3.1? | At this time, yes. The requirement is met until end of the support period. Under Microsoft’s current timelines, MS 2019 LTSC is in the security support period until 1/9/2029 and SQL Server 2019 is in the security support period until 1/8/2030. | |
| 13 | Combined Synopsis/Solicitation | In reference to ID 10 above, is an Infusion System with FDA 510(K) clearance - tested and evaluated with Windows Server and SQL Server 2019 or earlier be acceptable under the terms of this solicitation and eligible for award of an IDIQ contract with a period of performance starting on October 1, 2025 and ending on September 30, 2030? | MS 2019 LTSC and SQL Server 2019 are currently supported. Procurements after the end of the support period indicated in the response to ID 12 are prohibited because it would not meet the D.3.1 requirement. | |
| 14 | Combined Synopsis/Solicitation | In reference to ID 10 above, is there a time period within which a pump or a device purchased September 30, 2030 must be supported to help define useful life of the device? | The useful life is defined by the manufacturer. The OS requirement is separately driven by VA’s cybersecurity posture. Once an OS becomes unsupported (and cannot be patched), it presents a higher risk and is therefore prohibited to be procured. This is in accordance with VA Directive 6550. | |
| 15 | Combined Synopsis/Solicitation | In reference to ID 10 above, if not otherwise impacted by external factors (e.g., an FDA recall, or patient safety concerns), can an offeror propose a pump or device with a manufacturer end of sale date, or useful life date, of September 30, 2030, and still be eligible for award? Would such a pump/device meet the solicitation “useful life” and Operating System requirements and be eligible for award? | The useful life is defined by the manufacturer. The manufacturer is responsible for end of sale dates. It is not in the best interest of the government to procure medical devices with a known end of sale or end of service life that will occur before the end of the estimated useful life. As previously clarified in ID 11, the timelines for Active Support, Security Support and Extended Security Updates vary by release. For all releases of Microsoft OS, the VA will only procure new systems running an actively supported or security supported OS. | |
| 16 | Combined Synopsis/Solicitation | Does VA require secondary medication capability? If so, what are the accuracy requirements, and do they follow ISMP recommendations? | Primary/secondary is applicable to infusion pumps utilizing a gravimetric (vs. volumetric) pumping mechanism. Accuracy requirements are not defined by ISMP and will be evaluated through review/analysis of 510(k) documents by the purchasing facility. |
ISMP recommends a secondary IV infusion management systems that is not dependent on head height differential, but states in absence of this technology, the infusion library can be configured to enable primary only administration for specific medications/fluids.
| 17 | SOW | 9 | B.5 IV Stands | Does the VA require offerors’ to propose IV stands? Section B.5 sets forth specifications for IV stands, “should the contractor provide IV stands with the VA’s purchase of infusion equipment.” Solicitation at page 9. The use of the term “should” suggests that offerors are not required to provide IV stands. However, section 4.d of the Addendum to Far 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services, states that offerors shall provide with their submission a “complete list of consumables and supplies required for startup and operation.” Solicitation at page 44. IV stands are required for startup and operation. Please explain whether offerors must offer or provide IV stands them, and whether offerors must price them separately. | IV stands are not required to be provided. If acceptable, most VA medical centers plan to utilize their existing fleet of stands. However, if specific IV stands must be utilized with the offeror’s infusion pumps, which should be indicated in the complete list of consumables and supplies required for startup and operation, procurement of IV stands may be required. Please price the IV stands separately. |
| 18 | SOW | 8 | B.1 Large Volume, Syringe and PCA Pumps | Section B.1.14 states “any serviceable pump shall have the ability to be maintained by qualified VA biomedical technicians.” This statement is vague. Does this mean that the VA requires access to proprietary hardware, firmware, and software? What will the “qualified VA biomedical technician” require to maintain the pumps? What qualifications must the VA technician possess? Will the awardee be required to train VA technicians? If so, how many technicians must the awardee train and at what intervals? At what locations must technicians be trained? What assumptions should offerors make regarding this requirement so that they can intelligently structure their offers and compete on an even playing field? | Serviceable medical equipment refers to the repair and/or preventive maintenance of one or more parts. Maintenance frequency and procedures according to the Original Equipment Manufacturer (OEM) will be followed. If the OEM does not require preventive maintenance, this requirement does not apply. Offerors should assume that biomedical technicians have the industry standard qualifications, such as Certified Biomedical Equipment Technician (CBET). More information can be found in Section E, Training Requirements. Specifics, such as number of technicians that require training and locations, will be provided for each VA medical center in the fair opportunity solicitation. Biomedical Technician training offerings will be assessed upon receipt of response to each fair opportunity solicitation. |
| 19 | Combined Synopsis/Solicitation | The solicitation does not require integration with Alarm Management Systems. This is a commonplace industry requirement. Why has the VA not included this in its requirements? Will the VA add integration with Alarm Management Systems as a requirement? | No, there are various clinical communication/workflow platforms throughout the VA. Alarm management integration via the national IDIQ contract is not required. | ||
| 20 | SOW | 8 | Sections B.2.6 and B.3.5 state “the pump shall be validated by Oracle Health’s CareAware Platform to support medical device integration. Validation status will be evaluated upon receipt of response to each fair opportunity solicitation.” Please explain the delivery order process and how the Oracle Health CareAware validation status will be evaluated upon receipt of response to each fair opportunity solicitation? If Oracle is not available for integration at a hospital facility, will this be a requirement? | Oracle Health CareAware validation status will be evaluated at time of proposal submission in response to the RFP and at time of submission of offers in response to the fair opportunity solicitations. This evaluation is a simple verification for compliance. Even if Oracle is not available at a facility, the validation still needs to take place so the device is ready when Oracle becomes available. | |
| 21 | SOW | 8 and 9 | B. Technical Requirements | For Syringe Pumps, Section B.3.1 states “the infusion library/dataset can be transmitted to the pump wirelessly.” For PCA Pumps, Section B.4.1 states “the infusion library/dataset can be transmitted to the pump wirelessly or via a wired connection.” Today, the VA utilizes the Syringe Pump wirelessly or via a wired connection, like the PCA Pump. Can the VA explain the reason for the difference in infusion library/dataset management between the Syringe Pump and PCA Pump? Will the VA change the Syringe Pump requirement to equal the PCA Pump requirement, as utilized today? | Changes to a PCA pump library are very infrequent compared to expected changes for a large volume or syringe device library. Manually updating large numbers of pumps quarterly requires resources that create barriers to timely updates. Inventory of PCA pumps is generally far less than large volume and expected low frequency of changes makes a manual data transfer feasible. While this section impacts the transfer of the data set, it is important to note that interoperability between the Federal EHR and large volume and syringe pumps is required. |
| 22 | SOW | 9 | B.4 PCA Pumps | Section B.4.6 states that a “history of medication doses delivered to the patient and total amount over a specified time must be readily accessible to the end user.” See solicitation at page 9. Please identify the “end user.” | End user is defined as a member of the health care team (provider, nurse, pharmacist) participating in the care of the patient. |
| 23 | SOW | Section B.7.1 states “pumps enabled to communicate wirelessly with the VA network will also be able to provide any stored data in this manner on-demand, without manufacturer-imposed access restrictions.” See solicitation at page 10 (emphasis added). Since the solicitation requires all pumps to communicate wirelessly. See §§ B.2.1, B.3.1, B.4.1, D.3.2, it is unclear what the above, italicized language means. The solicitation also refers to “wireless devices,” see solicitation at page 10, and “wireless capable devices,” see solicitation at pages 11, 14. What are the distinctions between each of these three terms? | The requirements do not state that all pumps must communicate wirelessly, only large volume and syringe pumps. Pumps enabled to communicate wirelessly, wireless devices, and wireless capable devices are synonymous with 802.11 wireless networking devices. If the medical device supports wireless network connections, the FIPS 140-2 or 140-3 certification requirement applies. | ||
| 24 | SOW | 10 | B.7 Reporting | Section B.7.1 refers to data stored on pumps. See solicitation at page 10 (“Pumps enabled to communicate wirelessly with the VA network will also be able to provide any stored data in this manner on-demand, without manufacturer-imposed access restrictions”) (emphasis added). Is this stored data subject to HIPAA protections? Must it be encrypted at a level above that provided by the pump Operating System software? | Data stored on the infusion pump is required to maintain data at rest encryption. |
| 25 | SOW | 10 | B.7 Reporting | Section B.7.2 states “CQI data will be robust and reports will include established metrics to optimize DERS and improve infusion safety.” Solicitation at page 10. This provision further states “metrics defined by the Institute for Safe Medication Practices shall be considered standard of care for reporting and available at no additional cost.” Id. Since the VA is incorporating into the solicitation the metrics defined by the Institute for Safe Medication Practices, will the VA consider incorporating the infusion safety standards of the FDA and industry? | Infusion safety standards go well beyond the focus of this section, which is infusion pump CQI data (usage and alerts). ISMP was determined to be the most concise reference for these metrics and was included in the Statement of Work for that reason. |
| 26 | SOW | 10 | C. Integration and Project Management | Section C is titled “Integration” and Project Management, yet it does not contain integration requirements. Is the VA planning on adding integration requirements? | No, “integration” is not required. The solicitation has been revised accordingly, as needed. |
| 27 | SOW | 11 | D. Information Security | Section D.3.1 states “the infusion pumps shall run on an operating system currently supported by the operating system manufacturer.” Solicitation at page 11. Does this mean that the infusion pumps must run on an Operating System supported by the manufacturer at the time of award? What if, during the contract term, an Operating System is rendered no longer usable (e.g., through development of a new Operating System, recall, or a vulnerability assessment)? How will the VA, VISNs and VA facilities address such an occurrence? Will VISNs and VA activities be permitted to order pumps with a discontinued Operating System via the fair opportunity PO/TO procurements? Will the VA, VISNs, or VA facilities be permitted to order pumps using a new operating system developed after the award? What if the offeror introduces a new Operating System during contract performance, and the new Operating System requires new or updated hardware or firmware? Will VISNs and VA activities be permitted to order such pumps? Will these entities be permitted to order new hardware or firmware in order to accommodate the new Operating System? | Yes, the discrete device must run on an OS currently supported by the manufacturer at the time of procurement in accordance with the D.3.1 requirement. Unforeseen events that render an OS unusable may require a modification to the IDIQ contract. The details and final decision is made by the Contracting Officer on a case-by-case basis. |
VA is prohibited from procuring systems with unsupported or discontinued OSes in accordance with VA Directive 6550.
It is the manufacturer’s responsibility to maintain regulatory compliance and notify VA if at any point there are barriers to meeting the OS requirement. Any changes may require an updated or new VA Directive 6550 Appendix A to be submitted. The VA will work with the manufacturers to make appropriate updates to documented risk profiles of any medical devices currently in use.
| 28 | SOW | 11 | D. Information Security | Section D.3.1 state “the infusion pumps shall run on an operating system currently supported by the operating system manufacturer.” Windows Server 2019 and earlier officially ended mainstream support. While Microsoft will continue to provide security updates until January 9, 2029, the operating system is not receiving new features or bug fixes. SQL Server 2019 and earlier ended mainstream support and extended end date is January 8, 2030. An awarded IDIQ contract will have a five-year ordering period (1 Oct 2025 thru 30 Sep 2030). VA 6550, Appendix A prohibits procurement of devices with unsupported operating systems. Unsupported operating systems are OSs that are not supported by the manufacturer and have reached the end of the OS lifecycle as published by the OS manufacturer (i.e. no further security patches will be released for the OS by the manufacturer after the OS end-of-life nor will be available by other methods such as extended warranty purchases from the OS manufacturer). Assuming the IDIQ award is effective 1 October 2025 and ending 30 September 2030, is an Infusion System with FDA 510(K) clearance tested and evaluated with Windows Server 2019, SQL Server 2019 or earlier acceptable? What is the minimum OS requirement? | MS 2019 LTSC and SQL Server 2019 are currently supported. Procurements after the end of the support period indicated in the response to ID 12 are prohibited because it would not meet the D.3.1 requirement. The timelines for Active Support, Security Support and Extended Security Updates vary by release. For all releases of Microsoft OS, the VA will only procure new systems running an actively supported or security supported OS. | |
| 29 | SOW | 11 | D. Information Security | Section D.3.2 states “the infusion pumps or wireless cards shall be FIPS 140-2 or FIPS 140-3 certified if using 802.11 wireless networking.” Solicitation at page 11. This permits offerors to obtain FIPS 140-2 or FIPS 140-3 certification solely for the wireless card they will use with their pumps or devices, instead of obtaining FIPS 140-2 or FIPS 140-3 certification for the combination of the wireless card and the pump or device which will use the wireless card, as required by FDA 510(K) guidelines and regulations, and by NIST FIPS accreditation testing and evaluation regulations for Infusion Pump Devices. | ||
| Please explain why the above quoted language of section D.3.2 does not violate FDA 510(K) guidelines and regulations, and/or NIST FIPS accreditation testing and evaluation regulations for Infusion Pump Devices. | It is the responsibility of the manufacturer to comply with both the FDA regulations in determining if a new 510(k) is required and the NIST FIPS certification requirements. | |||||
| 30 | SOW | 11 | D. Information Security | In reference to ID 29 above, please identify the authority that permits only an offeror’s wireless card – and not the combination of its wireless card and the pump or device in which the card will be used – to be FIPS certified. | The NIST Cryptographic Module Validation Program confirms that a cryptographic module that has already been issued a FIPS 140-2 or FIPS 140-3 validation certificate may be incorporated or embedded into another product. A product that uses an embedded validated cryptographic module cannot claim itself to be validated; only that it utilizes an embedded FIPS 140-2 or 140-3 validated module. | |
| 31 | SOW | 12 | H. Performance Period | Section H states “delivery, installation, training, and integration will be evaluated at time of response to each fair opportunity solicitation.” Solicitation at page 12. This language is vague. How will these factors be evaluated? Against what will they be evaluated – a published standard, the content of other offers, etc.? | The solicitation has been revised accordingly, as needed. | |
| 32 | SOW | 13 | I. Ordering Procedures | Section I states that “all IDIQ contractors will be provided a fair opportunity to compete for each order unless an order is supported by an approved exception to fair opportunity justification.” Solicitation at page 13 (emphasis added). What constitutes an “an approved exception to fair opportunity justification”? | Please see FAR 16.505(b)(2). |
| 33 | SOW | 13 | I. Ordering Procedures | In reference to ID 32 above, are the “approved exceptions to fair opportunity justification” existing, published exceptions? Can they be created during the evaluation? If the former, where are they published? If the latter, who can create the exceptions and who must approve them? | Please see FAR 16.505(b)(2). |
| 34 | SOW | 13 | I. Ordering Procedures | In reference to ID 32 above, does a VISN’s, or VA facility’s desire to continue using a particular manufacturer’s pumps and/or devices constitute an exception to fair opportunity solicitation? | Please see FAR 16.505(b)(2). |
| 35 | SOW | 14 | J. References | Section J identifies the following as “References”: |
Institute for Safe Medication Practices (ISMP). ISMP Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps. ISMP; 2020. https://www.ismp.org/node/972.
| What does the designation of the above as “References” mean? What is the import of these documents? Must offerors comply with the substance of these “References”? Will offerors be more highly rated if they comply with the substance of the “References”? | Offerors must meet specific requirements within the Statement of Work, some of which are directly referenced in the citation listed. There is no expectation to comply with all recommendations listed within the referenced guidelines. Evaluations will be conducted pursuant to the terms of the solicitation. | |||||
| 36 | SOW | 14 | J. References | In reference to ID 35 above, can the VA identify which elements of ISMP are of particular importance in this procurement and in the PO/TO procurements? | ISMP standards that are of particular importance are in Section B.7.2 of the Statement of Work, including requirements B.7.2.1 – B.7.2.9. | |
| 37 | SOW | 14 | J. References | In reference to ID 35 above, can the VA define the minimum Infusion Pump flow rate accuracy requirement? Is the minimum +/- 5% industry standard for all ranges? | There is not a specified minimum requirement for accuracy. For large volume and syringe pumps respectively, please see requirements B.2.3 and B.3.2 for flow rate precision specifications. | |
| 38 | Combined Synopsis/Solicitation | 44 | E.1 Addendum to FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services | In section E.1, Addendum to FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services, paragraph 4.a states: |
Product brochures, technical specification sheets, and information for each proposed product solution, which shall include, but not be limited to, the following: a. For hardware evaluation: operating manual and device specifications including configuration options, cleaning instructions, and maintenance guides.
| Will the VA evaluate the substance of the offerors’ “hardware evaluation: operating manual and device specifications including configuration options, cleaning instructions, and maintenance guides” as part of the IDIQ procurement? | Yes. | |||||
| 39 | Combined Synopsis/Solicitation | 44 | E.1 Addendum to FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services | In reference to ID 38 above, will the VA evaluate the substance of the offerors’ “hardware evaluation: operating manual and device specifications including configuration options, cleaning instructions, and maintenance guides” as part of the PO/TO procurements? | Yes, pursuant to the terms of the fair opportunity solicitations for award of delivery orders (DOs). Please see revised SOW ordering procedures, which state, in part, that offers in response to the fair opportunity solicitations will be evaluated to determine whether they provide any additional benefits to the Government, including that: |
SPECIFICATIONS. The Government will assess the offeror’s product brochures, technical specification sheets, and other information presented for each proposed product solution, including warranty coverage, training offerings, allowable values for dose and concentration limits, and Dose Error Reduction System Software, against the technical requirements listed in the Statement of Work to determine whether the offer provides any advantages to the Government by exceeding the minimum requirements.
| 40 | Combined Synopsis/Solicitation | 44 | E.1 Addendum to FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services | In reference to ID 38 above, Will the VA evaluate the substance of these items, or just conduct a pass/fail evaluation? | VA will evaluate a proposed device's hardware in response to both the RFP and fair opportunity solicitations. For the RFP responses, evaluation will consist of a determination as to whether the proposed device is technically acceptable or not. For fair opportunity solicitations, VA will consider the potential benefits of a device's hardware specifications that may exceed the minimum requirements. | |
| 41 | Combined Synopsis/Solicitation | 54 | E.12 52.212-2 Evaluation—Commercial Products and | |||
| Commercial Services | Section E.12 states “each fair opportunity solicitation will identify the selection criteria for the applicable order.” Can the VA identify the minimum evaluation criteria that will be considered in the fair opportunity procurements? For example, can the solicitation be amended to state that “[a]t a minimum, each fair opportunity procurement will evaluate . . .”? | The solicitation has been revised accordingly to identify the minimum evaluation criteria that will be considered in the fair opportunity procurements. | ||||
| 42 | Combined Synopsis/Solicitation | In general, the VA does not address in the solicitation how it plans to manage new product releases and certificates post-IDIQ award? Will new devices be automatically added to the IDIQ and certificates accepted? Will the VISNS, or other VA activities, be permitted to order new product releases post-IDIQ award? | New product releases after award can potentially be added to the IDIQ contract through a modification. The details and final decision is made by the Contracting Officer on a case-by-case basis. |
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