36C10G18R0003-031.xlsx
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- 36C10G18R0003 Biologics
- Solicitation number
- 36C10G18R0003
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This document contains a pre-solicitation notice and related federal contract opportunity for biologics and biological implants. The Department of Veterans Affairs intends to issue a solicitation to establish multiple award IDIQ contracts for various types of biologics and biological implants used in surgeries and medical procedures. Products must be FDA approved and labeled in accordance with ISBT 128. Biological implants must be tracked from source to ensure patient notification for recalls. The government anticipates awarding up to 30 contracts under a one year base period and four one-year options. A draft RFP will be posted on December 15th for industry feedback, with a final RFP on December 31st. The solicitation will remain open continuously for one year with proposal submission cut-off dates in February, May, August and November 2018. All responsible sources must register in SAM under NAICS code 339113.
36C10G18R0003 Response to Vendor Questions 36C10G18R0003 .xlsx
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Sheet1
| Questions and Responses |
| Solicitation 36C10G18R0003 Biologics and Biologic Implants |
| Number | Page No. | Section Number | Question | Response | |||
| 1 | How will the orders flow? Will the VA order through Prime Vendors, and the PV send the orders to the Contractor to fulfill and drop ship to the VA? Please provide a flow chart of the proposed ordering process. | See Section 5.4 Ordering for ordering flow. Attachment 3 – Excel Price-Cost Schedule, TAB 2 – MSPV Participation, is merely an indication that offeror is willing or not willing to participate in the MSPV program. If willing, then the authorized Government Prime Vendor and awardee shall have agreement (terms and conditions regarding time, quantity, method of delivery, payment terms, and chargeback agreements) determined between awardee and Government Prime Vendor subject to coordination and final approval by the Government. | |||||
| 2 | How will the billing be processed? Through the Prime Vendor or direct from the Contractor? | See response to Question 1.A above. | |||||
| 3 | If Prime Vendors are used, is it the expectation that the PV will waive the administration fee? | The Distribution Fee charged by the Medical Surgical Prime Vendor (MSPV) Prime Vendor will apply and be chraged. | |||||
| 4 | 28 | C.12 SAC 16-01 | |||||
| a. | Will the 3% Service Level Agreement Fee be in addition to the .05% Industrial Funding Fee? | There should be no Industrial Funding Fee (IFF) fee since this is not a schedule purchase. | |||||
| 5 | 74 | Volume II - Price | Define Most Favored Government Customer, does this include DoD, IHS, VA, etc.? What is the time period, last 12 months, if other please provide the time frame? Also, customers that receive favorable pricing typically enter into future purchase commitments. Will this procurement lead to purchase commitments from VA customer? | See Section 5.4.6 Authorized to Purchase “ …/ Other Governmental Agencies will require an interagency agreement with the Department of Veterans Affairs to place orders against this IDIQ.” Currently there are no interagency agreements in effect. This procurement only guarantees the minimum commitment identified in Section 1.6 Contract Minimum and Maximum Dollar Values. | |||
| 6 | 8 and 12 | 3.1.15/5.2.3 | Of the three issuing agencies for the UDI labeling, is there a preference on which one to use? | Per Section 3.1.5 and 5.2.3, allograft products must be labeled using ISBT 128, while xenograft products may use any of the three standards. | |||
| 7 | 8 and 12 | 3.1.15/5.2.3 | Will the FDA implementation schedule for the UDI be followed? Please add or describe the schedule and implementation goals. | Yes, the Food and Drug Administration (FDA) implementation schedule for UDI will be followed. | |||
| 8 | How will the volume of the manufacturers be evaluated? If it ran through another vendor will that only be counted for the manufacturer? | ||||||
| Up until June 30, 2017, Vendor A's product SKUs were filled by Vendor A and Vendor Be. Please confirm that all Vendor A's SKUs will be attributed to Vendor A the manufacturer and that the other vendor will not be given credit for those sales in the evaluation as a basis for an award. | Products can only appear on one contract, either on a manufacturers contract or distributors contract but not on both. | ||||||
| 9 | 5 | 1.4.1 | Typically products shipped to the VA do not have patient ID associate with the order. Will the VAs start providing so this can be included? | There will no change to current order and shipping labeling requirements. | |||
| 10 | 5 | 1.4.2 | Is Microsoft Office encryption not an option? | No. | |||
| 11 | 8 and 73 | 3.1.5 / g (certifications) | The products being offered are Human Cell, Tissue, and Cellular Tissue Products (HCT/Ps) (as defined in the Food and Drug Administration (FDA) regulations 21 CFR Part 1271 and Section 361 of the Public Health Services Act (PHS Act). | 3.1.4 All Allograft products shall be Food and Drug Administration (FDA) approved and labeled in accordance with the International Standard for Blood and Transplant (ISBT) 128, which is the global standard for the identification, labeling, and information transfer of Human allograft medical products. Xenograft products may use any of the three currently FDA approved Unique Device Identifiers (UDI) including GS1 and HIBCC. Biological implants must be tracked from human donor or animal source at each step of distribution to implantation so that all patients who receive a biological implant by the VA can be notified of a recall subject to the evaluation by appropriate medical personnel. | |||
| They do not require FDA premarket approval or clearance. | |||||||
| A product is eligible for regulation as a 361 HCT/P solely under Part 1271 if it meets the criteria in 21 CFR 1271.10 and is not subject to premarket clearance or approval. | |||||||
| The products being offered meet all of the four criteria of HCT/Ps: | |||||||
| *Minimal manipulation | |||||||
| *No synthetic carrier added | |||||||
| *For homologous use | |||||||
| *Local implementation, direct to site: no systemic effect and not dependent on the metabolic activity of cells for its primary function |
| We understand ISBT 128 labeling is required for biological drugs and devices. It is currently not required for 361 HCT/P's. | ||||
| 1. Are we still required to follow the ISBT labeling? | ||||
| 2. If we implement, do we need to go back and relabel existing product using ISBT 128? | ||||
| 12 | 9 | 3.3.2 | Can the contract term be less than 60 months? | No. |
| 13 | 12 and 13 | 5.2.2 / 5.2.5.1 | The solicitation states that contractor shall offer "state-of-the-art" biologics/new products (pg12); however it also states that new additions will not be accepted during the 1st twelve months after award. Can you please clarify the process if a new product or version of the product becomes available during the first year of the contract? | During the first year of the contract award no new additions will be accepted for consideration of inclusion in the contract. |
| 14 | 14 and 38 | 5.2.5.2 / C.15 52.216-2 | Can you clarify price increases? Page 14 states only downward price changes are allowed but page 38 addresses price increases. | Section C.15 Economic Price Adjustment allows both price decrease and increase. No price increase will be considered in year one of the contract. |
| 15 | When is anticipated award effective date? | The latest anticipated award effective date will be 30 September 2018 with awards made on incremental basis dependent upon technical evalulation and fair and resonable pricing. | ||
| 16 | Please provide guidance for manufacturer response to solicitation that includes distribution through a named distributor. | We do not understand question and no response is provided. | ||
| 17 | Once all companies have been awarded for the IDIQ 36C10G18R0003 will there be a particular order in which each company will be allowed to provide the required supplies. For example a rotation of companies, lowest price, first response, etc.? | Orders will be placed by respective VA Medical Center based upon clinician determination as to best result for patient outcome. | ||
| 18 | Volume III requires an explanation of how large business will ensure that they sub contract out to small businesses. If your company is already considered a small business how would you suggest we respond to Volume III? As a small business we feel our company is adequately able to fulfill all supply orders for the entire duration of the contract with no assistance from other companies. How would you suggest we incorportae these details into our proposal and possibly into Volume III? | If offferor is a small business then Volume III is not required to be submitted. | ||
| 19 | Can reps and certs be completed in SAM or do they need to be attached as part of the submission? | Reps and Certs may be completed in SAM. | ||
| 20 | Our quality assurance plans are provided by our manufacturer, do you want his provided in our technical response or are you looking for a quality assurance surveillance plan from the company itself? | See Section 5.11.2 as contractor (offeror) shall monitor performance in accordance with company plan. | ||
| 21 | The soliciatation states under Delivery/Guidelines/Regulations, on pages 16-18, it talks about the different measures of payment for the awarded company based on a dollar value. What proof is needed to be shown in the proposal that the company is able to accept credit card payment? | Offeror is assumed to accept credit card payment unless exception is taken to this requirement. | ||
| 22 | 6 | 1.7.4 | Should Section B.11 read B 5.11? | Yes. See Amendment to solicitation conformed copy. |
| 23 | 8 | 3.1.5 | In regards to the "All allograft products shall be Food and Drug Administration (FDA) approved " statement, Do you consider products regulated solely as "361 products" FDA approved? (Regulated under 21 CFR 1271.3(d)(1) and Section 361 of the PHS Act). | See response to Question 8 above. |
| 24 | 9 | 3.2.1 | Should B.6 (delivery schedule) read B 5.6 Delivery Schedule? | B.6 should be B.5.6(delivery requirements) see Amendment to solicitation conformed copy. |
| 25 | 17 | 5.6.6 | Is it the intention of this IDIQ to have a unilateral Consignment Agreement or will a separate bilateral Consignment Agreement be negotiated by an authorized Medical Facility CO placed against the IDIQ? | Consignment agreements are bi-lateral and enetered into by each VA Medical Center if desired. |
| 26 | Attachment 6 | K & M | Should one of the sections be deleterd due to a duplication? | Yes. See Amendment to solicitaion. |
| 27 | Attachment 6 | L & N | Should one of the sections be deleterd due to a duplication? | Yes. See Amendment to solicitaion. |
| 28 | 12 | B5.4 | What impact will the MPT increase from $3500-$10K have on this RFP. Will it apply | Yes it will apply. |
| 29 | 40 | D1 | Would a detailed sales report, by facility, be acceptable vs. PO#/patient names/SSN for implants (HIPPA concerns) | D.1 is Invoice Inquiry Tracker for vendor to submit when payment inquiry is made and information is required for VA to research inquiry. |
| 30 | 69 | E16 | Please clarify the reason for the two submission dates | To ensure adequate number of responses by offers to anticipate maximum number of awards. If maximum number of awards are achieved after first submission date then the solicitation will be canceled. |
| 31 | 28 | C12A | Will the SLA Fee remain 3% for this RFP and will it be paid separately, each Quarter | Yes. |
| 32 | General Question | Will the awarding of this IDIQ affect ECAT eligibility? | VA IDIQ is separate and not part of DLA ECAT. | |
| 33 | General Question | When is award to be announced / made effective? | Each award will be annocuned when signed by the Contracting Officer and be effective upon award. | |
| 34 | 15 | 5.5 | Is the SLA fee in replacement of IFF or are they separate? | See response to Question 4 above. |
| 35 | Tech. Spreadsheet | What is the difference is Section L verses Section N? Letter of Commitment for Manufacturers | See response to Question 27 above. | |
| 36 | 1 | B | on Technical Sheet, answer YES for the same sheet? | Yes. |
| 37 | 15 | 5.5 | QSR template. Will you provide a template? | Yes. Template will be provided after contract award. |
| 38 | General Question | Vendor C recently acquired Vendor D. We are currently adding allVendor D products to the Vendor C FSS Schedule but it is still in modification. Should we submit 2 bids: 1 for Vendor C and it's products and 1 for Vendor D and it's products OR should Vendor C submit 1 bid and include all Vendor C and Vendor D products on that bid? | This solicitation is separate from FSS so 1 offer should be submitted with all products that prime vendor intends to offer for sale VA within scope of requirements. | |
| 39 | 13 | 5.2.3 | There are a few references to 510K approval throughout the solicitation document. Certain Human Cell and Tissue Based Products are regulated under Section 361 of the Public Health Service Act. Can we assume that 510K and 361 approval references are idential as appropriate for the type of biologic product offered? | See response to Question 8 above. |
| 40 | 17 | 5.6.4 | This paragraph reads, in part, that the supplier must be able to deliver any offered product within a few hours, seven days a week. This would appear to require the suppliers to have representative coverage of each VA medical center, each with the ability to deliver product within hours of a call. Is this the intent of this requirement? | Yes. |
| 41 | 73 | Vol I.g.1 | Does this requirement for lab certification apply to sterility testing? | Yes. |
| 42 | 5 | 1.4.2 | Do all Departments within the VA have access to view emails sent using Virtru Pro Program? | Virtru Pro Program emails contain the necessary ability for receipients to read. |
| 43 | 6 | 1.7.2 | What is the process if vendors request clarification on CDR's before responding? How quickly should the COR/POC respond to those types of requests? Will the Government consider assigning a local point of contact to coordinate questions/concerns and/or proposed resolutions with? Could the COR/POC decide to withdraw the CDR if additional facts made available warrant it? | The vendor will request clarification and the COR will reach out to the local medical center for information. The CDR is not withdrawn but if it is baseless, it is not held against the vendor. |
| 44 | 10 | 3.5.6 | Per paragraph 3.5.6 of the solicitation, the contractor is required to purchase, at their own expense, and install on contractor owned systems a specific brand of encryption software. This solicitation utilizes FAR part 12 policies and procedures and per FAR part 12 the Contracting Officer shall not include additional terms and conditions in a solicitation for commercial items in a manner that is inconsistent with customary commercial practice unless a waiver is approved in accordance with agency procedures. The solicitation will result in a commercial contract and commercial contracts shall follow commercial practices. We assert that the mandatory purchase, installation and use of a specific brand name of software is inconsistent with commercial customary practices and we request this requirement be removed from the solicitation. | No. Due to the requirement to encrypt PHI and PII information this is necessary for electronic exchange of information. |
| 45 | 18 | 5.6.6.7 | Consignment Agreement periodic inventories are currently left at the discretion of each particular VISN, but this solicitation requires quarterly inventories with a copy to the Contracting Officer. In our experience, the Government assigns inventory points of contact(s), usually within Logistics, and a local COR is assigned to develop initial inventories, in addition to validating periodic inventories. Will these methods be utilized for this requirement? If VISNs will continue to have discretion on the management of Consignment Agreement inventories, we recommend removal of the quarterly periodic inventory requirement. | No. If a Consignment Agreement is enetered into with VAMC the inventory is furnished to the ORDER LEVEL CO and COR not the contract award CO. |
| 46 | 73 | G.(4) | Pursuant to 21 CFR 801 and 21 CFR 830, commercial manufacturers of allograft products are required to adhere to FDA UDI labelling standards, which includes but is not limited to ISBT 128. As this solicitation is for commercial items subject to FAR part 12, the requirement of an exclusive labelling requirement for allograft products is inconsistent with customary commercial practices for allograft labelling and FDA regulations. Further, otherwise requiring the allograft manufacturer to certify its conversion from its current FDA compliant UDI system to ISBT 128 within one year, and the costs associated with this conversion, is also inconsistent with customary commercial practices. We request VAAR 852-211-172 and solicitation to be modified to permit product labelling to meet current FDA labelling standards. | See response to Question 8 above. |
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