MODIFICATION
36 -- Medical Oxygen Generation System (MOGS) IDIQ Contract - Amendment 2 - Attachment 4: Solicitation Questions and Answers
- Notice Date
- 7/18/2016
- Notice Type
- Modification/Amendment
- NAICS
- 333912
— Air and Gas Compressor Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-16-R-0001
- Point of Contact
- Lisa Zarick, Phone: 3016192336
- E-Mail Address
-
lisa.m.zarick.civ@mail.mil
(lisa.m.zarick.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- This document includes the questions and Government responses for this solicitation This solicitation amendment has been completed to incorporate a new Attachment, edit the APPs, and add additional language to FAR Provision 52.212-2. As a result of Amendment 2 to the solicitation, posted on 18 July 2016, the questions received in response to the solicitation have been posted along with the Government responses to each question. All questions and answers are listed below but are also available as an MS Word document incorporated as Attachment 4 to the solicitation. An SF30 Solicitation Amendmendment has also been posted as a result of this amendment which reflects edits to the MECs/APPs as well as the FAR Provision 52.212-2 - EVALUATION - COMMERCIAL ITEMS. The following are the questions and answers regarding solicitation W81XWH-16-R-0001. Offerors should refer to page 59 of the SF1449 solicitation attachment (or page 9 of the latest SF30 solicitation amendment) which states that an Offeror is not required to meet all of the Additional Performance Parameters (APPs) in order to receive a rating of at least "Acceptable" for the Phase Two Evaluations Factors. Therefore, the responses provided below are based on the stated APPs as these reflect the Government's expectation for an outstanding technical rating for the following Phase Two evaluation factors: Suitability, Reliability and Maintainability (RAM), Interfaces, and Safety. Note that the aforementioned amendment includes additional language regarding the best value tradeoff source selection procedures which will be utilized for the Phase Two evaluation. Through the use of these procedures, the Government may elect to award to other than the lowest priced Offeror, or other than the Offeror with the highest rated non-price proposal. Q1: We can offer a proposal for an Oxygen System and are willing to apply for 510(k) for it. However, we cannot predict the exact timeline for the approval and really are on mercy of the FDA inspector for the timeline. Will you consider our proposal, if at the time of awarding the contract we are still in the process of FDA 510(k) approval? Are there any ramifications if FDA inspector does not approve the system for 510(k) for some reason, while the contract has been awarded? A1: As stated on page 30 of the SF1449 solicitation, under 1.1.b. of the Minimum Essential Characteristics (MECs), the proposed system "shall be U.S. Food and Drug Administration (FDA) approved as a medical device and manufactured consistent with Quality System Regulation (QSR) at the time of contract award." Therefore, we cannot award to an Offeror for a device that is not FDA cleared at the time of award Q2a: The elevation at which the MOGS is operating will affect the size of the air compressor required for the system. For example, a 15 HP compressor will work up to 2,000 feet, whereas from 2,000 to 5,000 feet a special 15 HP air compressor would be required. From 5,000 up to 10,000 feet a 20 HP air compressor would be required. Larger air compressors affect layout, power requirements, heat removal, among other things. Additionally, a variable speed drive (VSD) air compressor option would be mandatory for this higher elevation. In order to adequately design the MOGS please advise on the elevation requirements and the highest elevation that the MOGS will need to operate. Q2b: What will be the design conditions for the system? We need this information to accurately determine the price for the system. For a system that will be used at sea level, a smaller air compressor is required than for a system that will be used at an elevation above sea level. Bigger the air compressor, higher will be the power consumption. It is not possible to design one system that can be used at all the elevation levels. A2: A likely operating location once systems are acquired, Bagram Airfield, Afghanistan is listed at 4,895 ft. Therefore, the Army may conduct operational (environmental) tests in accordance with MIL-STD-810G as part of the Phase Two field test at any elevation within the manufacturer's stated specifications of the device. Losses of throughput (or special care required for operation) above that elevation, will be considered along with other elements of the proposal, and should be detailed in the technical proposal. Note that the Suitability section (2.1.) of the Additional Performance Parameters have been edited to include the requirement for the system to operate up to 5,000 feet elevation (see page 4 of the SF30 solicitation amendment). Note that this solicitation will result in an Indefinite Delivery Indefinite Quantity contract and therefore, the specifics regarding the exact locations at which the system will operate are not known at this time. Q3: Additional information regarding ambient temperature is needed to accurately determine the price for the system. A system operating at low ambient temperatures might not need chiller and aftercooler. Whereas system operating at 120 deg. F at high relative humidity levels will require a chiller, aftercooler and bigger filters. Also, for higher operating temperatures, air compressor cost is significantly higher than at normal ambient conditions. So it is critical to know the exact location or the ambient conditions to design the system. A3: As stated on page 32 of the SF1449 solicitation, under 2.1.i. of the Additional Performance Parameters (APPs), "the system shall operate in ambient temperatures of 0° to 120° F and ability to operate up to 130° F is desired." Note that the priority at these higher temperatures would be to supplying oxygen directly to the patients as filling cylinders likely would not occur in such extreme temperatures. In terms of possible locations that these systems will be used, operation in humid, tropical locations such as the Caribbean and coastal regions along the Persian Gulf is very likely. For example, USAMMA operates a medical equipment depot, from which these systems could be shipped, in Qatar. Therefore. during the Phase Two field test, the Army may conduct operational (environmental) tests in accordance with MIL-STD-810G at any conditions within the manufacturer's stated specifications of the device. Losses of throughput (or special care required for operation) at the extremes of the ranges cited will be considered along with other elements of the proposal, and should be detailed in the technical proposal. Note that this solicitation will result in an Indefinite Delivery Indefinite Quantity contract and therefore, the specifics regarding the exact locations at which the system will operate are not known at this time. Q4: There are several extreme weather conditions stated in section 2.1 - Additional Performance Parameters. How likely these will be the operating weather conditions? A4: While the most extreme conditions cited are possible, extreme conditions are, by their nature, less likely. Losses of throughput (or special care required for operation) at the extremes of the ranges cited will be considered along with other elements of the Offeror's proposal, and should be detailed in the technical proposal as the source selection procedures utilized for Phase Two will best value tradeoff. Note that this solicitation will result in an Indefinite Delivery Indefinite Quantity contract and therefore, the specifics regarding the exact locations at which the system will operate are not known at this time. Q5: Will this be just a cylinder filling plant or an additional product outlet required to also provide oxygen at 50-60 psi as stated in section 1.1 - Minimum Essential Characteristics. If both options are desirable, will there be a situation when product oxygen will be used for some purpose while the cylinders are being filled? This will determine the size of the oxygen compressor needed. A5: As stated on page 31 of the SF1449 solicitation, under 2.1.a. of the Additional Performance Parameters (APPs), "the system shall be able to simultaneously fill cylinders and provide patient oxygen. Priority shall be given to providing patient oxygen." We cannot discontinue oxygen supply to patients while cylinders are being filled. Q6: Suitability (p.31, Section 2.1): What is the minimum number of cylinders that must be filled simultaneously? A6: As stated on page 33 of the SF1449 solicitation, under 2.3.f. of the Additional Performance Parameters (APPs), "the system shall interface with the high-pressure Hospital Oxygen Backup System (HOBS) (uses Swagelok QTM series quick-connect) via hoses provided with the system." This system has eight "H" cylinders in a manifold. Q7: Suitability (p.31, Section 2.1): What is the minimum number of cylinders to be filled per day and their size? A7: Small "D" size cylinders that can readily be carried by a single person are the most common ones used by the Army, but filling of large cylinders is likely. Proportions of small and large cylinders would depend on the mission. Once someone is working to fill cylinders in a deployed location, it is reasonable to assume that they would work continuously for several hours. The detailed test plan that will be provided with the Phase Two instructions will include specific information. Q8: Operational temperature (p.32, Section 2.1.i): Can the MOGS utilize external attachments/devices (e.g. snorkels and/or vents) from the enclosure to dissipate heat? A8: Such attachments are not prohibited, but would need to be deployable with the system in a reasonable fashion. While the MOGS system must operate outdoors in a broad range of conditions, operation in an area with limited headroom is also possible. Q9: Storage temperature (p.32, Section 2.1 n): Can the MOGS utilize heaters or similar devices to assist with cold weather storage? A9: During the Phase Two field test, the systems will be tested in accordance with MIL-STD-810G. The most likely exposure of the MOGS system to extreme temperature conditions is in storage. While the military services take precautions to protect medical equipment, exposure to extreme cold in storage, without benefit of heaters is quite possible in forward locations or in air shipment. Based on the actual location that the system is operating, the system may not have the option to be stored in a heated warehouse or be plugged in for cold weather storage. Q10: Storage temperature (p.32, Section 2.1 n): To the extent the MOGS is stored and/or unused for long periods of time in extreme weather temperatures, can a storage maintenance prerequisite (e.g. battery replacement, electronic checks, system evaluations) be incorporated as part of the normal startup procedures? A10: Reasonable precautions and procedures to take the MOGS out of storage or maintain it in storage cited will be considered along with other elements of the proposal, and should be detailed in the technical proposal. Such precautions and procedures should also be included in the system manuals submitted with the proposal. However, the expectation is that the system should be able to be removed from long-term storage without damage that a medical maintainer cannot prevent or fix. Q11: Refer to section 2.3., Interface: Can the MOGS allow for cylinder filling outside of the MOGS enclosure via high pressure flex hose connection? A11: As stated on page 33 of the SF1449, 2.3.a., the MOGS must be able to fill both small "D" Cylinders and larger "H "cylinders. Therefore, it seems unlikely that the larger cylinders could be filled while inside the MOGS enclosure. Q12: Refer to section 2.3., Interface: Will the charging system require a fragmentation protection and if so, what is the minimum size of the fragmentation box? A12: We have no explicit requirement for fragmentation protection for cylinder filling incorporated within the charging system. Cylinders may be secured for filling in a number of different ways. Q13a: Refer to section 2.3., Interface: Can the MOGS control panel be mounted external to the MOGS enclosure? Q13b: Refer to section 2.3., Interface: Does the MOGS control panel need to be environmentally protected and operated outside of the MOGS enclosure? A13: The system is intended to operate as a single device with controls as part of the device, whether surface mounted or recessed. Controls must meet the same environmental requirements as the device itself. Q14: Refer to section 2.3., Interface: The solicitation requires that the MOGS delivers 50-60 psi of oxygen to the mobile medical facility. What is the type of connector or connection to the mobile medical facility? Is there a requirement for a multi-connection manifold mounted to the MOGS? A14: Per the Additional Performance Parameters (page 33, 2.3.e.), the system shall interface with the low-pressure Patient Oxygen Distribution System (PODS) or Surgical Suite Oxygen Distribution System (SODS) (uses Swagelok QC series quick-connect) via hoses provided with the system. As a result of this amendment the acronyms for PODS and SODS have been spelled out within the APPs. Q15: During usage and maintenance what is the minimal footprint of open space around the MOGS? A15: The MOGS could be operated in a variety of environments, including a warehouse, a tent, or outdoors without protection, the footprint will have to include both ventilation and sufficient room to perform maintenance without moving the system unnecessarily. Minimum clearances required to operate and maintain the proposed system should be specified in the operator's manual, and the Army will set up the system in accordance with the manual. Q16: Refer to Reliability and Maintainability (p.32, Section 2.2 d): Are the tools in the BMET tool kit required to meet the Berry Amendment standards? A16: The BMET tool kit is the standard toolkit issued to the maintainers in the field and not something that the Government is requesting as part of this requirement. The list of items included the BMET tool kit (listed as Attachment 1 to the solicitation) is provided for informational purposes to allow Offerors to review the tools available to the USAMRAA field maintainers and determine if additional non-standard or proprietary tools are required for the setup, operation, and maintenance of the proposed system. These tools will make up the tool kit described under 2.2.d. on page 32 of the solicitation and are subject to the Berry Amendment. However, in accordance with PGI 225.7002-1(a)(1)(ii)(2)(C) the requirement to buy hand or measuring tools produced in the United States does not impose any restriction on the source of the components of the hand or measuring tools. Q17: For the Phase One Technical Proposal, Section 1 Executed Solicitation Documents, are we to include a signed copy of the entire SF1449 solicitation package with no pricing in the schedule, or are we to include a signed copy of the SF1449 cover page along with the representations and certifications pages from the solicitation package? A17: Either option is acceptable however, providing only the SF1449 cover page along with the representations and certifications pages from the solicitation package is preferred. You are correct that pricing is not a requirement for the Phase One proposal. Q18: Page 50 Section 4.3 lists the requirements for the Technical Proposal, including addressing how the MOGS complies with each element of the PWS and MECs. This section also asks whether our MOGS solution meets any of the APPs. Responding to specific APPs during the Phase One Technical Proposal seems to contradict the instructions outlined on page 48 of the solicitation. Specifically on page 48 it states that Phase One "evaluation will be based on whether or not the proposed systems meets all the Minimum Essential Characteristics (MECs)...and Performance Work Statement (PWS)." There is no references to addressing APPs. Please advise whether we are required to address the APPs in our Phase One technical response or if the APPs are to be addressed in Phase Two. A18: Offerors are not required to address the APPs in the Phase One Proposal in order to receive a technically acceptable rating. Offerors are invited to include this information in the Phase One proposal for the purposes of demonstrating to the Government evaluators how the proposed system meets or exceeds the minimum requirements. However, page 53, section 5.1.1. (of the SF1449 solicitation) includes instructions for preparing updates to the Phase One Technical Proposal to include the details to demonstrate how the proposed MOGS meets or exceeds any of the APPs, etc. Q19: Are the APPs used as part of the evaluation process for Phase One? It seems from Section 1.1 on page 57 that only the PWS and MECs will be evaluated during Phase One, but the Technical Acceptability Section 4.3 on page 50, requests a response to how our MOGS meets any of the APPs. Please advise. A19: Additional Performance Parameter are not used as part of the evaluation process for Phase One. As stated on page 57 under 1.1. Factor 1 - Technical Acceptability, there is no impact on an Offeror's Technical Acceptability rating if an Offeror does not provide documentation demonstrating how the proposed systems meets the Additional Performance Parameters. Q20: For the Phase One Technical Proposal, do you want offerors to provide a complete list of items referenced in subparagraph (i), (ii) and (iii) on pages 50-51? Or in the alternative, do you merely want "a statement or other means of demonstrating" our ability to provide the required lists as described? A20: A statement confirming that an Offeror is able to provide this information is acceptable. For example, on page 51, bullet g under section 4.3. (of the SF1449 solicitation) includes the information that should be included in the required Operator's instruction manual, maintenance service manuals. Part of this list are "parts, tools, test equipment, and consumables lists." Therefore, a statement can be provided indicating that this information is included within these manuals. However, as section 5.2.1. (on page 54) includes the requirement to provide itemized pricing for the consumables, repair and replacement parts, and all special tools within the price proposal, the Government is not requiring these itemized lists as part of both Phase One and Phase Two. Therefore, a statement confirming an Offeror's ability to provide this information is acceptable for the purposes of the Phase One evaluation.
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