SPE2D1-15-R-0001_AMENDMENT_0004.pdf

SOLICITATION SPE2D1-15-R-0001 AMENDMENT 0004

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(1.) I have a question on Attachment #3 Discount & Pricing Information. Item 6 on that document is a bit confusing, as it reads:

6. Installation and Instruction (Training) Provisions

Submit your standard commercial installation and instruction provisions, or specify where they may be found in your catalog or price list included with this offer.

Provide the percentage (or percentage range) or the catalog list price that your STANDARD COMMERCIAL GUARANTEE is valued at: _____ OR from _____ to _____.

I'm wondering if it's a typo where it asks for the value of the Standard Commercial Guarantee.

Should that be the value of Installation and Instruction Provisions? Standard Commercial Guarantee is covered in number 5.

DLA/VA RESPONSE: See revised Attachment #3 (v.2) addressed in section (1.) of Amendment 0003.

(2.) Page 41, IX. GOVERNMENT INSPECTION, ACCEPTANCE, AND PAYMENT TERMS AND CONDITIONS/(b) Final Inspection/Acceptance. The term “Substantial Clinical Use” was removed from the Acceptance clause of the current contracts because “substantial” was vague and disputable. We request that the clause be modified to replace “Substantial Clinical Use” with “Clinical Use” in all instances. If the clause will not be modified, please provide a measurable definition of “substantial clinical use”.

DLA/VA RESPONSE: See section (3.) of Amendment 0003.

(3.) Page 51, XII. CONTRACT AND DELIVERY ORDER PRICING REQUIREMENTS/(e) Government Audits. The paragraph contains the sentence, “Outside of audits at time of award the Government reserves the right to invoke audits during the life of a contract.” We request its removal. The standard for Commercial Item procurements is Comptroller General Examination of Record; that clause is included elsewhere in the RFP. The fixed-price contract review is limited as well, considering vendors are being paid a pre-determined price and price reasonableness is determined at the outset. If the sentence is not removed, please clarify what audits the Government is contemplating in this language and the basis from which those audit rights derive.

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DLA/VA RESPONSE: The language is not being removed. The Government reserves the right to invoke VA IG Audits at Contracting Officers’ request. This may include but is not limited to, validating EPA adjustments, supporting the evaluation of product addition requests, and other pricing evaluation.

(4.) Page 52, XIII. Item Addition and Deletion/(a) Item Additions. The RFP states, “At any time during the performance of this contract, the Contractor may request addition of new items.”

Currently both DLA Troop Support and VA NAC limit contractors to one quarterly submission for new items. Is that restriction truly lifted for the new contracts?

DLA/VA RESPONSE: There is no restriction on the number of requests. However, based on workload, quality of supporting information and/or number of requests; the Contracting Officer may implement other procedures/restrictions on the number of submissions.

(5.) Page 49, XI. Equipment Requirements/(h) Repair Parts for Deployable Systems. The text states, “To affect efficient, easy purchase of repair (spare) parts by the Government, it is highly desired that vendors include all such spare parts in their price book.”

a. Repair part numbers change very frequently. How often can the Government support changes and updates to the price book for them?

DLA/VA RESPONSE: See response to question #4 above.

b. Can the Government guarantee payment will be made if the part number changes between ordering and shipping/invoicing?

DLA/VA RESPONSE: No. Vendors are only authorized to provide the Government the part numbers specified in a delivery order or in a delivery order modification.

(6.) Statement of Work Section X, a) Operational Time (page 44) states that Unit must be operable and available for use 95% of the normal operational time until expiration of the warranty. Does this requirement include deployable equipment and OCONUS sites?

DLA/VA RESPONSE: Yes, the same requirement applies for OCONUS sites and deployable locations.

(7.) Statement of Work Section X, c) Emergency and Routine Maintenance (page 45) states that an onsite response time of 4 hours is required during work hours. Please clarify:

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1. Is the intention of this language to include software only products?

DLA/VA RESPONSE: No

2. Some of our products are handled through depot service (where equipment is replaced with a loaner or new system). Would the 4 hour onsite response time requirement apply to these?

DLA/VA RESPONSE: Yes

3. Does an onsite response time of 4 hours apply to OCONUS and deployable systems?

DLA/VA RESPONSE: Yes, for OCONUS locations such as Hawaii, Alaska, and US territories. For other OCONUS locations the requirement does not apply and the onsite response time will be established in the specific delivery order. For deployable situations, if the equipment is being delivered and put into clinical use at a CONUS medical facility the requirement would apply. Once the deployable system is relocated from that medical facility, the requirement would no longer apply.

(8.) Statement of Work XIV. Extended and Turnkey Installation Requirements, c) Turnkey Installation, 5) Shielding (page 55).

1. Will the VA’s Registered Physicist of record determine and provide the documents outlining the calculations for the lead shielding requirements for the imaging system?

DLA/VA RESPONSE: Yes, unless physicist services are otherwise specified as a vendor provided service in the turnkey requirements.

(9.) Statement of Work XVII. Information Technology Requirements, IT Contract Security (page

61) states that the VA Configuration Guidelines are available upon request.

1. Will the Government please provide the VA Configuration Guidelines?

DLA/VA RESPONSE: See VA Handbooks 6500 and 6550 at http://www1.va.gov/vapubs/search_action.cfm?dType=2.

(10.) Statement of Work XVII. Information System Design and Development (page 62 – page

64) identifies systems that are designed or developed for, or on behalf of VA, at non-VA facilities are systems specifically designed/custom-made for the VA.

1) Please confirm that these requirements are not applicable to commercial-off-the-shelf products and systems.

DLA/VA RESPONSE: No, the requirements, as outlined in the Information System Design and Development section, apply to COTS products.

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(11.) Can MRI-safe patient monitors be included in the new contracts, as MRI accessory items?

DLA/VA RESPONSE: Yes, these are within scope of the program

(12.) Per our conversation, we would like to know, if we need to complete Appendix C Conformance Checklist (starting on Page 39 – Attachment 1) as part of our submission.

DLA/VA RESPONSE: Yes, the checklist must be completed.

(13.) STATEMENT OF WORK XI. EQUIPMENT REQUIREMENTS – (f.) SERVFICE BULLETINS: Recently, the FDA has encouraged contractors to adopt an email system for submitting recall and update notices. (1) In light of this FDA guidance, is email submission an acceptable form of delivery?

DLA/VA RESPONSE: Yes, email submissions are acceptable. See section (4.) of Amendment 0003.

(14.) STATEMENT OF WORK X. WARRANTY – (a.) OPERATIONAL TIME & (c.)

EMERGENCY AND ROUTINE SERVICE: Warranty uptime requirement states that “Operational time is considered from 7:00 am to 10:00 pm. Monday through Friday”. However, paragraph (c.) Emergency and Routine service states “All service covered by Warranty shall be provided during normal Government work hours (8:00 am – 5:00 pm, Monday through Friday, excluding federal holidays). In essence, downtime is being calculated outside of the hours that a vendor is authorized to provide service and could result in a vendor being unable to meet the uptime requirement. Additionally, the operational time doesn’t exclude federal holidays.

(1) Will the operational times (a.) be modified to reflect the authorized service hours in section (c.)?

(2) Will the downtime calculation be modified to only reflect those hours that are included in the authorized service hours in section (c.)?

DLA/VA RESPONSE: No, the requirement will not be changed. The two requirements referenced in this question are not the same.

(15.) Comment: STATEMENT OF WORK XI. EQUIPMENT REQUIREMENTS – (d.)

APPLICATION SOFTWARE AND OPERATING SYSTEM REQUIREMENTS:

The requirement that equipment must be fitted with the latest operating system (OS) “major release currently available for purchase in the commercial marketplace or no older than one release prior to the latest major release” poses potential safety and security concerns as well as

6 | P a g e continuity of operations concerns. In our experience, major Commercial OS releases are seldom more secure or stable than prior versions initially, often for several years. We strongly recommend the Government reconsider the practical feasibility of allowing installed and stable OS versions to continue to be used and serviced until the newer versions are deemed safe and secure as well as to allow the contractor the ability to develop a transition plan that maintains and ensures continuity of operations.

Recommendation: Strongly recommend that the Government consider modifying the requirement with recommended, or similar to, language as indicated in italics below:

Application software (e.g. image acquisition, manipulation, reconstruction, analysis, display, etc.), and any Off the Shelf commercial Operating System (OS) necessary for operation and maintenance of the system being purchased, are to be provided by the contractor. The OS should be the latest major release currently available for purchase in the commercial marketplace or no older than one release prior to the latest major release. Older releases may be considered acceptable if authorized in writing by the requesting facility and approved by the Contracting Officer. Application software updates compatible with the offered system's hardware shall be kept current at no additional cost to the Government as long as the equipment is in use. Once the OEM makes a new OS major release available for purchase in the commercial marketplace, the system purchased cannot be connected to an installation’s network with that latest major release until it is deemed safe and secure by agency security experts and the vendor through a formal certification and accreditation process. The vendor shall implement an OS transition plan which includes a prudent sunset period for support of the then-current installed OS (irrespective of the release version). In addition, this transition plan shall ensure continuity of operations. OS versions which have reached end of life and are no longer supported by the OEM will not be eligible for a waiver. As part of the transition plan, the vendor must provide an operating system that will be able to be updated with continuous security patches until the new OS can be supplied. For the purpose of this clause…..

DLA/VA RESPONSE: The Government is unable to accept this recommendation.

(16.) Question: STATEMENT OF WORK XII. CONTRACT AND DELIVERY ORDER PRICING REQUIREMENTS – (2.): The Government states that the vendors shall complete and provide Attachment #3 as part of this initial proposal and provide updates throughout the life of any resultant contract.

(1) Are the updates required only to include information for product lines or systems to be added to the Price Book?

DLA/VA RESPONSE: No. The attachment must be updated whenever there are changes to commercial pricing.

(2) If not, since pricing and discounting are established at time of award and notwithstanding the Economic Price Adjustment clause, could you please provide an example of why an update to Attachment #3 would be required?

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DLA/VA RESPONSE: This is required for a number of purposes including support for EPA provisions and in order for Contracting Officer to make a determination that the vendor’s price is still fair and reasonable prior to option exercise.

(17.) Under section XI(f) on page 47, can the service bulletins be sent via e-mail?

DLA/VA RESPONSE: See section (4.) of Amendment 0003.

(18.) In reference to section XVI on page 57, can you please provide a list of the restricted facilities that will require security clearances?

DLA/VA RESPONSE: No such list is available. Vendors need to inquire at each facility or Service Logistics Offices as security requirements are subject to change.

(19.) Under section XVII(c) on page 57, please provide clarification as it relates to security/privacy awareness training. In particular, what is included in the training, where would it take place, how long would it take, and how much does it cost? Additionally, if a vendor is able to do their own training, where can they get a copy of the required content?

DLA/VA RESPONSE: Vendors need to inquire at each facility or Service Logistics Offices as security requirements are subject to change.

(20.) ls the DLA/VA NAC willing to enter into negotiation with vendors if exceptions are taken to some of the terms and conditions?

DLA/VA RESPONSE: In accordance with FAR Part 15 and the Solicitation on page 72, section g, the Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror’s initial offer should contain the offeror’s best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer;

and waive informalities and minor irregularities in offers received.

(21.) What is the expected warranty requirements under the construction services and systems?

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DLA/VA RESPONSE: There is no construction services and systems section in the solicitation.

The warranty section in the solicitation applies to equipment and any incidental services.

(22.) XI Equipment Requirements: b.) Operator training. Can you clarify that this is referring to ‘clinical’ in nature rather than ‘service’?

DLA/VA RESPONSE: Operator training is for the clinical users of the system so the system can be operated correctly.

(23.) Page 9 - FAR Clause 52.212-4(p) – Limitation of Liability:

Please confirm that each vendor’s liability is limited to the price actually paid by the DLA/VA for the product or service

DLA/VA RESPONSE: No. This section of the clause only addresses consequential damages resulting from any defect or deficiencies in accepted items, unless otherwise provided by an express warranty.

(24.) Page 13 – FAR Clause 52.230‐5 - Covenant Against Contingent Fee:

Please confirm that pursuant to FAR Clause 3.404, this clause does not apply to commercial items.

DLA/VA RESPONSE: Clause is being removed via section (6.) of Amendment 0003.

(25.) Page 13 – FAR Clause 52.215‐2 - Audit and Records – Negotiation:

Please confirm that pursuant to FAR Clauses 15.209(b) and 15.303‐1, this clause does not apply to commercial items.

DLA/VA RESPONSE: Clause is being removed via this via section (7.) of Amendment 0003.

(26.) Page 17 – DFAR Clause 252.209‐7001 - Disclosure of Ownership or Control by the Government of a Terrorist Country: Please confirm that DFAR Clause 252.209‐7001 is a reserved section.

DLA/VA RESPONSE: Clause is being removed via section (8.) of Amendment 0003.

(27.) Page 37 – Section III - Contract Administration:

Please add the VA’s local delegation of authority of order under $50k to this section of the Solicitation

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DLA/VA RESPONSE: No delegation of ordering authority is included in the solicitation.

(28.) Pages 37-38 – Section V - Delivery Requirements: Please consider adjusting this timeline to avoid delivery date modifications. Instead of a timeline, a range of time may be beneficial to the government to avoid multiple delivery date mods.

DLA/VA RESPONSE: The Government is unable to accept this request.

(29.) Page 38 – Section VI - Delivery Order Placement Procedures:

The evaluation criteria for order selection will be tailored to each requirement. Pricing will always be a factor in order selection. Low price technically acceptable or trade-off factors may be used to make delivery order selections.

Clarification requested – the VA currently uses a best value evaluation system with trade-offs (language below). Will this change in the new contract?

Evaluation factors:

The evaluation factors are: 1) Availability of required features (Technical and Functional); 2) Availability of Service; 3) Vendor Past Performance; and 4) Price

All non-price factors when combined are significantly more important than price.

DLA/VA RESPONSE: Delivery order placement procedures will be specified in accordance with FAR Part 16 and page 38, section VI of the Solicitation.

(30.) Page 44 – Section X - Warranty, Subsection (b): At a minimum, the Contractor shall provide a one-year warranty from the date of Government acceptance.

The solicitation has conflicting information on the warranty start date. Please change this section to read the same as Page 41 - any applicable warranty period will commence on the date the notice of readiness for inspection

DLA/VA RESPONSE: The date of the notice of readiness for inspection is not always the same as the warranty effective date. See section (5.) of Amendment 0003.

(31.) Pages 46-47 – Section XI – Equipment Requirements, Subsection (e)(1):

All equipment and related peripherals contracted for shall be state-of-the-art technology Clarification requested: Please clarify that the term “state-of-the-art” includes all current products sold in a commercial market. It is not the government’s intention to buy a basic system, but expect delivery of a premium model.

DLA/VA RESPONSE: The term “state-of-the-art” has already been defined as “"the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation.” It may not include all products sold in the commercial marketplace and is not necessarily related to the difference between a “basic” and “premium” model.

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(32.) Page 50 – Section XII – Contract and Delivery Order Pricing Requirements, Price justifications:

Clarification requested: Please clarify that invoices and/or GPO comparisons may be required to justify the price justifications.

DLA/VA RESPONSE: Yes, invoices will be required and GPO comparisons may be required.

(33.) Page 51 – Section XII – Contract and Delivery Order Pricing Requirements, Country of manufacture for parts. Our products are sold and meet the TAA clause as a system not as individual parts, please change the pricelist to reflect the country of end product manufacture of the systems on contract.

DLA/VA RESPONSE: See section (11.) of Amendment 0003.

(34.) Page 53 – Section XIV – Extended and Turnkey Installation Requirements, Subsection (b)(4): Site preparation work necessary to provide for fully functional system, not specifically identified in the Work Statement, but required for operation, is the responsibility of the contractor Clarification requested: The contractor shall draft its Work Statement to provide for the site preparation for a fully functional system based on the information known at the time of preparing the quote

DLA/VA RESPONSE: The Government is unable to accept the requested change.

(35.) Page 54 – Section XIV – Extended and Turnkey Installation Requirements, Subsection (c)(3): Unless otherwise specified, all materials used in the turnkey installation effort shall be new and of first rate quality.

Clarification requested: Unless otherwise specified, all materials used in a turnkey installation effort shall be new and of first rate quality, unless the Customer asks Contractor to reuse any materials.

DLA/VA RESPONSE: See section (9.) of Amendment 0003.

(36.) Page 55 – Section XIV – Extended and Turnkey Installation Requirements, Subsection (c)(3)(vi):

Clarification requested: Vendors shall take reasonable care and precaution by surveying installation sites to determine the acceptability of the facility power and grounding system(s).

The term “surveying” will not include a time-related study. However, after Vendors makes a determination that facility power and grounding systems are acceptable, if site preparation and

11 | P a g e construction is not being subcontracted by the Vendor, its responsibility will be limited to quoting and supplying a UPS or other power generation system if requested by the Government.

DLA/VA RESPONSE: This requirement is under Section (c) Turnkey Installation, and therefore would apply only to those delivery orders where the Contractor is required to perform Turnkey Installation. Accordingly, the requirement will remain unchanged.

(37.) Page 55 – Section XIV – Extended and Turnkey Installation Requirements, Subsection (c)(5): Shielding type, thickness and placement in floor(s), wall(s) and/or ceiling(s) shall be determined by the Contractor's American Board of Radiology (ABR) registered physicist Clarification requested: Shielding type, thickness and placement in floor(s), wall(s) and/or ceiling(s) shall be determined by the Contractor’s American Board of Radiology (ABR) registered physicist, unless, in order to save cost, these determinations shall be made by a qualified physicist available at the site.

DLA/VA RESPONSE: See section (10.) of Amendment 0003

(38.) Page 56 – Section XIV – Extended and Turnkey Installation Requirements, Subsection (c)(5)(iii): For RF shielding, Contractor shall furnish the service of an independent testing laboratory , approved by the Contracting Officer, to verify the integrity of the RF shielded enclosure. Contractor shall certify that the testing laboratory is equipped and staffed to perform field tests of RF shielded enclosures, and perform these test as a normal service. Upon completion of the imaging equipment installation and RFsealing of the shielded room the independent testing laboratory shall test the RF shield in accordance with industry standards. All testing shall be performed with shield room door(s) closed and the imaging equipment operating under full range of load conditions. Test reports shall be submitted to the Contracting officer and the on-site Government point of contact. All deficiencies shall be rectified and work affected by such deficiencies shall be completely retested at the Contractor's expense.

Clarification requested: The RF shield is tested after it is built and after delivery of the magnet prior to operation, by the RF shield vendor. When we are reusing an existing RF Shield, it is tested prior to doing any work, then again after repairs/modifications, and then again after the magnet is delivered.

(39.) Page 74 – Special Instructions for the Submission of Proposal Information, Subsection (f):

Clarification requested – Since the products may change between the solicitation response and the final award, and as documented in the current imaging contract, please clarify - Certification of 510K submission received, certification will be provided upon request.

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(40.) Page 75 – Special Instructions for the Submission of Proposal Information, Subsection (j):

Clarification requested: Please clarify “system trees” are requested to identify the segments of a full system. Commercial product datasheets and brochures may meet the same needs

DLA/VA RESPONSE: Commercial product datasheets and brochures may be used to identify the segments of a full system. Furthermore, utilizing a block diagram to identify the segments of a full system can be used versus system trees.

(41.) Your guidance would be appreciated. Our company, $^%$^%$%$^%$^% , provides maintenance service worldwide on &^*&^*^&^ and ^%^%&^%^&%*%’ CT, MRI, and PET/CT Imaging Systems. We don’t provide the actual new equipment but we do provide Independent Service Organization (ISO) maintenance services on this equipment once the initial warranty period has expired. We are an alternative to the Original Equipment Manufacturer maintenance services. We have existing CT, MRI, and PET/CT maintenance service contracts with government facilities at the ^&^*&^*&^(*^ and others.

I realize that the predominant goal of this solicitation is the acquisition of new imaging modality equipment and warranties. As a provider of ISO maintenance services, there does not seem to be an exclusion that would prohibit us from submitting a bid to provide on-going CT, MRI, and PET/CT maintenance service for equipment manufactured by ^&^&^*&^(*& and ^*&^&*^&*^& once the manufacturer’s warranty has expired. Could you provide some clarification on this situation as we do plan to provide a quotation for on-going maintenance services?

DLA/VA RESPONSE: There is no exclusion on offering third party maintenance under the program.

(42.) (*()&*&*&(*& would like clarification regarding Attachment 3 - (Discount and Pricing Information) - Please define how you want the value percentage of Questions 5 -7 calculated. An example would be helpful.

DLA/VA RESPONSE: The value percentage is the percentage of list price the item is valued at.

It also indicated that vendors can provide catalog list price instead of the value percentage.

(43.) I forgot to ask this question, our standard practice in our proposal response, is to respond or clarify directly in a copy of the solicitation. Do you have a preference if we respond directly in the solicitation or include our clarifications in a proposal letter format?

DLA/VA RESPONSE: Only the representations and certifications should be completed and submitted directly within the solicitation. All other responses/clarifications to the solicitation

13 | P a g e should be submitted separately in the vendor's proposal, with any clarifications clearly identified as such with full references provided to the applicable page/section of the solicitation for which the clarification applies. Other portions of a vendor's proposal should be labeled to match section headings (a.) thorough (o.) of the Special Instructions for the Submission of Proposal Information, on pages 74 through 76 of the solicitation.

(44.) Another question....p 49 of 100 of the Solicitation, XII:

1. The contractor will be required to submit invoices to substantiate prices and discounts...given to commercial customers within similar purchasing environments...equal size to the Federal Govt"....We do not have customers of equal size to the Federal Government, but we have sold to individual US military bases, etc. ...is that what you want to see?

Or just our largest sales (sometimes to private businesses)?

DLA/VA RESPONSE: Only commercial invoices should be provided. Individual sales to the Government will not be sufficient.

(45.) Can we include an attachment/matrix to the Attachment 3’s for this bid, as opposed to completing a separate sheet for each category.

DLA/VA RESPONSE: Yes, attachments may be provided along with Attachment #3.

(46.) In our response, do you truly want a hard copy PO of the price books, commercial and attachment 5, or do you only want these electronically on the CD?

DLA/VA RESPONSE: No. The price book and commercial price list should only be submitted electronically via CD/DVD.

(47.) I have been completing my review with management and they asked me about the contractor's right to cancel the contract. I've reviewed the agreement and cannot locate an out clause for the contractor. Is there one? If so could you please direct me to it.

DLA/VA Response: There is no such clause in the solicitation.

(48.) The worksheet asks for commercial customer name and invoice info for the products we would be selling with this contract. As a private company, we prefer to keep our customer names private. Are we obliged to give the customer names, or can we just give invoice number and pricing info?

DLA/VA Response: Unredacted invoices with customer name are required. Please review pages 49-52 of the solicitation for required information.

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(49.) I think this is it – your paperwork says Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions or commercial items for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately. Can you explain what is meant by “offer”? We are listing all parts and pieces and pricing. Did you want quotes for systems with certain configurations? In addition to the price/part list?

DLA/VA Response: This is standard FAR language. A vendor may submit multiple offers if applicable, but is not required to do so. The Government does not desire separate offers for systems with certain configurations nor separate price/part lists.

(50.) For clarification, is Attachment #5 required for this RFP? This looks to be the pricing file template.

DLA/VA Response: This will constitute the offered pricing and the pricing of any resultant contract. Previous Amendment 0001 clarifies which tab must be completed.

(51.) Is this file #4 a file to submit pricing? Not sure what you may be looking for in this file.

This is called a quote, but we have a number of systems that could qualify. So we do not submit this Attachment 4 for the RFP?

DLA/VA Response: Attachment #4 only applies for quoting Government requirements after award and no action is needed as part of the RFP.

(52.) Except as provided herein, all terms and conditions remain unchanged and in full force and effect. The original closing date is not extended.