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1.Question: Is there a projected date when the contract, once awarded, would be operational?? We are trying to give our IT department an idea of when we’d need this capability to be operational.Answer:? We are projecting the operational; capability to begin between late November 2016 and January 2017. However it is not possible to predict with any certainty at this time.2.Question: For clarity, could you please verify that in order to propose the addition of a particular product that was not on Attachment D.2, we only need to create a Pricing Schedule (a Sub-CLIN) for the proposed product on the applicable tab on Attachment D.1?? There is no separate document or advance notice that you require regarding additional products we would like to propose?? Should we keep the same estimated quantities stated for that CLIN on the new Pricing Schedule (sub-CLIN) for the proposed product?Answer: See E.2 Instructions to offerors3.Question: Are the estimated quantities based upon historical purchasing by the VA of particular HCPCS/L Codes?? Additional explanation of the quantities estimated, or maybe a more detailed forecast, would assist us in determining pricing.?Answer: They are a projection based on historical purchases by VA but?we have not received projections from the Department of Defense. Since items will be prescribed as needed by each patient, it is very difficult to project how many of each specific device will be required each year. Please see 52.212-2 Evaluations as it describes how we will determine the estimated quantities for all awarded items. Also, note that this solicitation is for IDIQ contract(s) and those are used for estimated and uncertain quantities.4.Question: Vendor X will be proposing additional products on Attachment D.1, and therefore will be providing descriptive literature for those items offered.? In what format would the VA prefer those materials?? Would a document with URL links to various electronic materials suffice or should we provide PDFs of all literature? Answer: Both please5.Question: Several of our products are complex and contain several part numbers. Some of these products are selected through configurators to ensure all the needed parts are included on the order and other parts are bundles of parts numbers.? In both cases the PO may state one part number but the invoice will show several part numbers that make up that item.? In this ordering system does [sic] the line items on the PO need to match exactly the line items on the invoice including exactly matching the price? Or is there some flexibility when matching the PO to the invoice?Answer: The part number(s) you provide should be for the main item. The part number is for our reference and is not used for invoice matching.6.Question: Similar to the above question, what level of detail for part numbers are needed? For example the 1C60 Triton foot is actually hundreds of part numbers representing the exact side, size, color, etc., such as 1C60=R28-3-P/4N, which is the part that is ordered on the PO and it appears on the invoice along with the 2 sub components of 1C60=R28-3-P/0 and 2C6=R28/4N.? For pricing information and for ordering information which level of detail is needed?? Answer: See answer to #5, above. At this time we are only collecting part numbers that are returned on the invoice for future use. The numbers are not stored in ROES. 7.Question: What product information is needed to be loaded and maintained in this ordering system?? Product images, descriptions, documentation, etc.?? From an IT perspective, what EDI message standard would this contract require compliance with? Answer: You will be required to submit a product data file and technical specification sheets in .pdf format products included in your contract. The format for the product data file is set forth in the document entitled “Artificial Limbs Data Text File” included in this amendment. The text file will include the name of the appropriate .pdf appropriate for the product data so that they can be matched in ROES to the actual .pdf file.. 8.Question: A few of the descriptions of the Otto Bock liners on Attachment D.2 are too general for us to pin point exactly which liner is considered approved.? For the three below, could you verify whether we have listed the applicable part number/material number for the liners that were considered approved?L5673 Locking Liner ProductPrimary Stated FeaturePart No./Material No.Silicon LLsilicone, durable, low to moderate activity level 3,6mm x15sizesx6Y70Standard Pro LLsilicone, durable, low to moderate, matrix level 3,6mm x15sizesx6Y42TFsilicone full matrix, low to moderate active. x6Y80Answer: You would need to submit prices for each (size/descriptor) if there is price variation or one price as a group if there is no price variation.9.Question: The list of approved products needs to be updated as some products have been discontinued and others have been added. How do we note that in our Bid? Answer: If the item has been discontinued then annotate that on the item that has replaced it. If an item is truly not manufactured anymore and there is no replacement please annotate that in a memo or list so we can adjust our list of items.10.Question: The list of approved products includes main items, what about accessories such as those listed in section B.12. in the contract draft?Answer: We would interpret this to mean all accessories associated with an approved item are also approved.11.Question: Bid says feet must be available sizes 22-30.? Will feet be excluded that are not available in the full range?Answer: (Please see B.12 Group 1 (PF) c.1. in Amendment 2) Must be at least foot size 24-30cm for male feet and at least 22-28cm for female feet (may also offer smaller and larger sizes).12.Question: Bid requires control devices and PDA’s to be included with the foot or knee.? Does that include all brands? Answer: Yes, unless specific items are listed as exempt. 13.Question: Must each MPK include a PDA or can we offer with and without option?Answer:? You may offer a “with” and a “without” option.14.Question: Do electronic devices need to be serialized?Answer:? Serial numbers are only required on Group 1, Prosthetic Feet and Group 2, Prosthetic Knee Units, and then, only if it is your standard commercial practice.15.Question: There is no L5999 foot tab, can we add that for ProFlex and RKXC? Answer: You may propose a new item for evaluation under the suggested LCode as long as you send in all the required information for items not currently listed in D.2. OK for Proflex as L5999, however we could not locate RKXC on your web site.16.Question: Only one item will be awarded, Must bidders choose between offering bundled packages vs individual? Answer: The RFP states that “shall include any and all associated microprocessor(s), motor(s), power source (battery)(s) and control device (e.g. PDA), and control software as applicable.” ?However, see answer to question #13, above.??17.Question: Can Non-listed items be added?Answer: Yes, see Section E.2 for instructions on the submission of non-listed items. 18.Question: Will there be a process for adding new products as they come out during the Term- Custom Dermo liners, Iceform liner, etc?Answer: Yes, amendment 2 adds a clause for technology refreshes.19.Question: Will only ROES orders be considered “on Contract”?? If ROES is optional for DOD, when are DOD items considered “Off contract”? Answer: ROES is the only contractually authorized ordering mechanism for any resulting awards for these requirements. ROES will be mandatory for ordering from these contracts. Orders not coming through ROES are to be considered “open market” or by some other contracting arrangement. 20.Question: Will off-contract require same pricing as on-contract?Answer: We do not address items we are not putting under contract. The objective of this RFP is to obtain contract pricing for the terms specified.21.Question: Shipping is set at FOB destination with no exception for expedited orders. ?Can exceptions be made and how?Answer: In accordance with FAR Part 47.304-1(f) shipments will be on an FOB destination basis, whether expedited shipping or regular shipping. We are requiring contract prices to include transportation costs. It is our belief that requests for expedited shipping will be rare as well as shipments to OCONUS locations. Also, see answers to questions 30, 32 and 33. 22.Question: For Company hosted Product training, are there any attendee/selection requirements?Answer: See Section B.16. The individuals must be DOD or VA employees to receive any training under the resulting awards since those are the only two agencies authorized. Training is intended for those that would be involved with the prescription of the devices and continuing care.23.Question: For the additional discount (Rebate) Is the Base figure only for “on contract’ items?? Is the additional rebate on sales above the base figure or back to dollar one?Answer: It is not required to offer this Rebate. However, if offered it shall be consistent with your commercial practice and it would only apply to this contract. 24.Question: We follow ISO 13485 which is based on ISO 9001 plus additional requirement. ?Does that need to be noted in the agreement?Answer: We will be amending the RFP to reflect acceptance of ISO 9001 and/or 13485. See amendment changes. 25.Question: How are any (if any) exceptions to the terms be noted?Answer: If you are referring to the FAR and VAAR terms and conditions, those are required by law and/or regulation and no exceptions will being entertained. If you are referring to portions of the statement of work, those should be detailed in your technical proposal. If the evaluation of your proposal determines them to be unacceptable, your proposal may be rejected.26.Question: The bid is to be submitted via a CD.? Is a flash drive acceptable? Answer: No. VA network security procedures prohibit use of flash drives that are not encrypted using VA-approved encryption technology. Submission on CD is required as stated.27.Question: When do you expect awards to be announced?Answer: After evaluations are complete and internal reviews and approvals are obtained. We are not able to predict an answer this question at this time. Also see answer to question #1, above.28.Question: When do you expect to go live? Answer: See above answer to question #1.29.Question: Will ROES training/technical support be available to contractors? Answer: Yes. The IT group that manages ROES is located at the DALC and does offer support to vendors that have current contracts with the DALC. 30.Question (Part 1): Please clarify C.3 52.211—9 Desired and Required Delivery Schedule Answer: We will be removing this clause and clarifying the delivery requirement to 5 days for CONUS delivery and 7 days for OCONUS delivery under B.11 Delivery.Question (Part 2): Is this to mean when an item would be delivery after receipt of purchase or does this means when after award of contract will contractor be available to accept purchase orders?? The contract after award and knowing which lines the contractor will be awarded.? Then knowing which items to setup in their IT systems to receive orders for and establishing processing receive order and transmit required data that will take a reasonable period of time.? Normally there is an implementation time (45-90 days) after award of a contact.? Will there be an implementation period on this contract.Answer: Yes, there will be an implementation period but that has not been defined as of yet since this product line is a new effort for DALC and we have no historical timeline to use as a guide. 31.Question: When items are covered on multiple L Code, how should these items be annotated on the bid tables.Answer: See attachment #1 under sample CLIN.32.Question: Will orders be potentially received from all U.S. territories including American Samoa, Guam, Philippines, Puerto Rico and Virgin Islands? Answer: Orders are likely to be received from the VA facility in Puerto Rico, but not likely from American Samoa, Guam, Philippines or the Virgin Islands?33.Question: Will the 5 day delivery schedule required for deliveries to U.S. territories.Answer: ? The requirement will be changed to 5 days CONUS and 7 days OCONUS. See answer to question #30, part 1, above.34.Question: Is the $25,000 Guaranteed Minimum for each 12 month period or $25,000 for the base year and any option periods combined?? Answer: The $25K guarantee is for the entirety of the contract, the entire projected 5 years.35.Question: Will the government pay freight for expedited deliveries?Answer: See above answer to question #21. 36.Question: On B.12 (a) there is a reference to serialized according to FDA regulatory standards 21 CFR 801.420; however the CFR cover hearing aids aid devices.? If a prosthetic foot, knee or liner is not currently serialized by the manufacturer dos that make that item ineligible for award under this contract.Answer: See above answer to questions 6 and 7. If serialization is not your standard commercial practice it is not necessary. The requirement will be changed.37.Question: Page 32, Volume II Technical Proposal we could not locate an attachment titled IT/Interfacing Requirements.? We only locate attachment D.4 electronic transaction record layouts. Answer: That is the correct attachment we will amend to correct this. Additionally see document entitled “Artificial Limbs Data Text File” being added to Attachment D.4 by this amendment.38.Question: Will the implementation of this contract roll out all VA Orthotics and Prosthetics facility at the same time or will there the a phase roll out of facilities.Answer: The intent is to have this available to all facilities at the same time. We cannot guarantee that this is what will happen though as this is an initial attempt to standardize the process for the agencies so there could be some variations in the pacing of agency adoption as this is rolled out. 39.Question: Will there be a requirement to provide Data Sets for the lines that each contractor is awarded.? If so, what are the format and submission requirements for the Data Sets?Answer: See answer above to questions #7 and #37. All items will be included in the data text file.40.Question: Is there an allowance for items on Backorder or is this contract fill or kill?Answer: Your PO acknowledgement shall indicate if the item is on backorder and then the clinician will make the determination to wait for the backordered item or cancel and order another item. 41.Question: Electronic Transaction Records Layout – Document is there a proposed methodology (electronic/manual) for maintaining parts and pricing?? If so, please elaborate.Answer: This will be a function of the data text file. Language is added via Amendment 2 to provide a mechanism for the periodic (once every 6 months) introduction of new products, under B.21 Technology Refresh and Exchange. Contractors will need to keep the file up to date, particularly as technology is refreshed or updated. Also, see answer above to question #7.???? 42.Question: When new VA facility is added to the contract how will contractor be notified? Answer: The ordering clinic and delivery clinic address will be on the order placed through the ROES system. 43.Question: Electronic Transaction Records Layout - Document???????? Purchase Orders what is different about a routine versus priority purchase order, i.e., field indicator.Answer: This is how the facility would identify an expedited “priority” order. 44.Question: How will the contractor accept or reject the Expedited Order?Answer: The PO acknowledgement would show the status indicator as “pending shipment” for acceptance or “not available” for rejection.45.Question: VA791-16-R-0116-008.xlsx????????? Invoices; Can Invoice numbers contain a dash (-) to allow for backorders? ?Are there specific invoice requirements for backorders?Answer:? Invoices can only be submitted for items that have shipped. Your PO acknowledgement would indicate the status as “backordered” for ordered but unshipped items. ??? 46.Question: VA791-16-R-0116-008.xlsx????????? Invoices;?? what are the requirements for the certification record?? Is this a separate document? Answer: Your invoice needs to include the certification statement. It is not a separate document.?47.Question: VA791-16-R-0116-009.xlsx????????? Invoice Reject File; how is invoice rejections resolved, change to original invoice, and issuance of credit or debit?? Can you provide various examples?Answer: There is a specific invoice reject format that will be returned to the vendor. They are expected to make corrections and return the invoice in a new invoice file with a new invoice number.48.Question: VA791-16-R-0116-011.xlsx????????? Return Authorization; ?? Can the return authorization number contain a dash, i.e., 25789-00?? Will an Order Acknowledgement document suffice?Answer: ?There is a specific record format for a return authorization. The RA number may contain a dash but must adhere to length requirements. See return Authorization layout in Attachment D-4.?49.Question: Does “trial period includes 1 model change” mean the clinician can change the foot or knee for a different model from the same line (ex. Change a highlander foot with spring category 4 for the same highlander but with spring category 7) or does it mean they can exchange the foot or knee for a totally different type (ex. Change a total knee with hydraulics to a 3R80 from O.B.)? What does “one change with the package” mean?? The solicitation states the trial period will not change as a result of requested modification or replacement.? Does that mean the 30 days starts over after modification/replacement or does not start over??Answer: The trial period requirement is being removed by Amendment 2.50.Question: Upon review the manufacturers listed on the product list for knees, 8 of the 11 manufacturers listed do not have trial periods.? Since only 27% of the manufacturers have a trial period, it appears this is not “industry standard” for knees.? Answer: The trial period requirement is being removed by Amendment 2.51.For feet 9 of the 11 manufacturers have trial periods, being that 82% have a trial period we can safely say this is “industry standard”. For those manufacturers that do not allow trail period would the VA consider using loaner units instead of having a trial period? Answer: The trial period requirement is being removed by Amendment 2.52.Many of the O&P suppliers on the approved item list have stated that they do not have ISO 9001 certifications, but ISO 13485.? Is it possible that the VA will accept ISO 13485 in lieu of ISO 9001?Answer: We have amended the solicitation to read ISO 9001 and/or 13485. Also see answer to question #24, above. 53.Question: In lieu of a Trail Period would the VA consider using loaner units instead?Answer: The trial period requirement is being removed by Amendment 2.54.Question: Will the VA be returning items after the 30 days period after purchase?? If so, will the VA pay restocking fees for returning items after the 30 day window?Answer: No, if a 30-day period has passed the Government will not return the item in question.55.Question: Will items returned during the trial period be in resalable condition? Answer: The trial period has been deleted. Our intent is to return all items that need to be returned, in a condition that would allow for resale.56.Question: There are a few of the knees we listed that are now manufactured in China, unless you say otherwise I will NOT submit those knees.Answer: If the items are approved by the technical evaluation team and, if acquisition of them is in accordance with the Trade Agreements Act they may be accepted (Note: This applies to all products manufactured outside of the U.S.).57.Question: I was wondering if would could sent the package out by Friday (would this meet your deadline requirements?)Answer: (Note: this question was posed when the proposal due date was Friday, September 2, at 4:00pm) We cannot ensure the delivery of your proposal and do not take responsibility for it until we have received it. The proposal must be received by the date and time specified by the RFP or any amendment that may change that date and time. 58.Question: The proposal asked to send it out on a CD will this still be the preferred method? Answer: Yes, CD is the method identified for proposals. Also see answer to question #26, above.59.Question: Also we are an ISO 13485 certified company (Which is for medical devices) is this acceptable in lieu of ISO 9000?Answer: We have amended the RFP to reflect acceptance of ISO 9001 and/or 13485. See answer to questions #25 and #52, above.60.Question: Would you clarify the difference between CLIN worksheets 1AA and 1AB etc. on the Pricing Submission worksheet – the assumption is that they are for multiple products in the same L-Code….is that correct? Answer: That is correct; it is for offering more than 1 item under an L-Code.61.Question: Would you confirm that there will be multiple awards per L-Codes? Answer: We anticipate multiple awards under every L-Code but only one award per specific make and model. We cannot say for certain as we aren’t at the award stage but we do anticipate multiple awards per CLIN (L-Code).62.Question: We have recently changed our item numbers on some of the prosthetic liners.? They are similar profile, just different fabric color and distal connection.? May I include these in the bid as well? As the original numbers will be discontinued over the next 1.5 years.Answer: Yes you may include them, however please identify the associated items for any transition so we are able to update our records. This shall be in accordance with the technical refresh language added by this amendment. 63.Question: I noticed the delivery date is 5 days from the date of order. When the bid is awarded, will the supplier have adequate time to adjust inventory where necessary?Answer: There will be an implementation period after contract awards are made to allow all parties involved a reasonable amount of time to prepare for incoming orders. ................
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