ATTACHMENT G - RFP QUESTIONS SPREADSHEET.xlsx
XLSX spreadsheet 23 KB Posted
- Attached to
- 4610--Dialysis Systems and Associated Maintenance Services and Consumables (VA-21-00023786)
- Solicitation number
- 36C10G21R0019
About this file
This document includes a government file containing questions and answers related to a solicitation for dialysis systems and associated maintenance services and consumables. Key details include:
The Department of Veterans Affairs requires dialysis systems including water purification and distribution systems, integrated water purification and dialysate delivery systems, hemodialysis systems, continuous renal replacement therapy systems, and peritoneal dialysis systems. The solicitation allows for the purchase of systems for in-center use and leasing of systems for home use. Questions cover delivery locations, payment methods, system sizes and configurations, definitions of terms, training requirements, and other contractual and technical issues. Clarification is provided around regulatory requirements, notification procedures, and responsibilities of VA facilities and vendors.
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Other files
| File | Type | Posted |
|---|---|---|
| 36C10G21R0019 0001.docx | DOCX document | |
| ATTACHMENT A - SOW -- Final 6-14-2021.pdf | ||
| ATTACHMENT C - PAST PERFORMANCE QUESTIONNAIRE_update.docx | DOCX document | |
| 36C10G21R0019 0001.docx | DOCX document | |
| ATTACHMENT F - TECHNICAL RESPONSE MATRIX.pdf | ||
| ATTACHMENT C - PAST PERFORMANCE QUESTIONNAIRE.docx | DOCX document | |
| ATTACHMENT E - UNIVERSAL REQUIREMENTS.pdf | ||
| ATTACHMENT D - MTRs.pdf | ||
| ATTACHMENT A - SOW.pdf | ||
| ATTACHMENT B - Pricing Schedule.xlsb.xlsx | XLSX spreadsheet | |
| 36C10G21R0019_2.docx | DOCX document |
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Text version
Sheet 1
| Document | Document Section Reference | Question | Response to Question | |
| SOW | 4. ADDITIONAL REQUIREMENTS FOR LEASE/RENTAL SYSTEMS (FOR HOME USE) | 1. 4. C – Delivery: Contractor shall deliver systems and consumables (Including Dialysis Solutions) directly to the ordering Medical Facility? Wouldn’t this only be the cycler and in-center use consumables? Usually the consumables are sent directly to veterans home. | Modified SOW Section 4c: Contractor shall deliver systems and consumables (Including dialysis solutions) to the ordering Medical Facility or Veterans home at the direction of the VA at the time of order placement. | |
| RFP | General | The solicitation says multiple award, can there be two different vendors awarded for supplying the same supplies? | Yes, there can be two or more different vendors awarded for supplying the same category of products/supplies. | |
| SOW | 4. ADDITIONAL REQUIREMENTS FOR LEASE/RENTAL SYSTEMS (FOR HOME USE) | 4. J – Invoicing: If veteran is set up in middle of month, the charges shall be prorated to only the days used in the month. Currently the manufacturer prorates the cycler cost to when it’s sent in, but the facilities typically send to the veterans home a full order with some reserve to account for physician changes to the prescription on new patients. | Generically speaking, charges shall be prorated to only the days used in the month. Specific situations will be determined with the ordering facility at the time of order placement. | |
| SOW | B.1 CONTRACT ADMINISTRATION DATA | Under the SOW, it states: “A Government Purchase Card is the preferred method of payment for home use orders. As a result, the Contractor shall accept the Government Purchase Card VISA Level II for payment and charge separately each Veteran specific order.” | ||
| Which way will vendors submit payment requests? | Vendors will submit payment requests IAW government purchase card payment procedures. Vendors will follow the procedures as provided by the ordering facility at the time of order placement. | |||
| Pricing Schedule | All-inclusive consumable pack for Non-Pharmaceutical peritoneal dialysis system? Do you want one price to include all Dialysate, Cartridge, and all ancillaries? Not Line item pricing? Do you want the same for All-inclusive consumable pack for Pharmaceutical peritoneal dialysis system, with any medications needed included in price? | Vendors shall provide one price, but provide a list of the products that are included in the all-inclusive pack. This applies to non-pharmaceutical and pharmaceutical all-inclusive packs. | ||
| SOW | Page 17 Section 5. a) 4) Sizing | Company offers 12 different sizes of Central Water Treatment Systems. These sizes will overlap the 3 sizing criteria included in the RFP : 1 – 12 station; 13 – 25 stations; 26 – 38 stations; 38 – 51 stations. We want to quote all of our different sizes so that these prices can be reviewed in the RFP. We can stipulate which sizes fulfill which of the ranges in the RFP and the criteria we have used for those sizes. Please note, in addition to the number of stations in a facility other equipment can consume product water (i.e. bicarb and acid mixers and maintenance stations) Is this plan acceptable? | Please respond IAW the RFP in providing four prices for four sytem size ranges (1-12, 13-25, 26-38, 39-51). Additional size and price information can be provided however VA will determine whether this information will be considered. | |
| RFP | page 125, Vol 4-Solicitation , Offer and Award Documents - item #2 under instructions | We don’t find where we can print a registration certificate. Does the following suffice? If not can someone advise on how to print what is needed? | The Offeror is required to return a copy of the certification with their offer or complete the annual representations and certifications electronically at the System for Award Management (SAM) at https://www.sam.gov. If SAM is completed, the Offeror shall provide a copy of their SAM record. If you require assistance, please contact https://sam.gov/content/help | |
| Attachement D | attachment “d”, MTR regarding Item #4 (which is also called out in Attachment “B”, Pricing Schedule, lines 14-17) | a. | What are the scenario’s under which you are looking to lease? For example, to have as a transitional system, during an upgrade to a new install, a brand new install by which the site is just leasing for a period of time? | |
| b. | Second question, same item number: What type of system are you looking to lease: a complete system: including pretreatment, RO, post treatment? It’s not specific with regards to the expectation. | |||
| c. | Third question same item number: what leasing terms are you looking for? 24 months, 36 months, etc? | Each of the scenarios referenced applies: transitional system, during an upgrade to a new install, a brand new install by which the site is just leasing for a period of time. The types of systems include a complete system: including pretreatment, RO, and distribution. The terms of lease include: monthly lease for short term duration (1-3 months), 6-month lease, 12-month lease, 24-month lease. | ||
| Attachement B | CLIN 0001AA / AB / AC | 1. | The cells in columns “Discount %” and “Discount Unit Price” and “Total Quoted Price” are not presenting the value in the right fashion. See above. The math does not add up, etc.. Are you fixing it or do we fix it? | |
| 2. | On May 10th I asked this same question regarding “total quoted price”, and was answered that “Total Quoted Price” includes the discount. The above formula still does not illustrate that. Again, do we adjust the formula to reflect or leave it alone? | The offeror shall submit an accurate proposal that includes showing the Discount percentage appropriately. | ||
| Attachement B | CLIN 0001AA / AB / AC | the vendor is asked to provide a single price for a very wide range in size of system, 1-12, 13-25 ,etc. . Items within these 3 configurations will vary in size, etc. For example, the price of a 25 station system will be more than a 13 station configuration. Thus the VA will be overpaying for a smaller system in any of these 3 ranges. Question is: are the prices in column “Unit Price” fixed for any system ranging from 13 to 25? | The prices are fixed for each range of system size: four prices for four sytem size ranges (1-12, 13-25, 26-38, 39-51). | |
| RFP | B.3 Price/Cost Schedule, starting page 8 | Since there is a pricing schedule Attachment B, do we also fill in the Unit Price/Amount on pages 8-83? Thus listing the same pricing for both documents? | ||
| Please advise if “yes” we fill in the pricing in the Solicitation document, or we don’t. thank you. | Complete the pricing schedule only (Attachment B). | |||
| RFP | Universal Requirements for all systems, services, consumables | Item aa. Shipping and Delivery: | ||
| Question: Please design “all orders” in the first sentence. Do you mean a complete system, parts, etc? please provide specifics. | Each order placed shall be delivered in total, to include all items that are part of that particular order. | |||
| RFP | Page 17, B.3 | What does “supply” mean in the following CLIN descriptions 0005AB, 0005AC, 0006AD and 0006AE: All-Inclusive (Portable Integrated/Hemodialysis) System Maintenance, Testing, and Supply Agreement? | These CLINs refer to Maintenance, Testing and Supplies/Consumables IAW SOW Section 3. | |
| RFP | Page 20, B.3 PRICE/COST SCHEDULE | Does “CRRT” mean only FDA approved devices that have a CRRT trademark or does it apply to FDA approved devices that can perform continuous extended renal replacement therapy? Limiting to a trademark could be considered restrictive. Requiring or describing an FDA approved treatment capability is the recommended language that would provide the Government the most flexibility and options for care and appropriate treatment for patients. | Modified SOW Section 5h: Continuous / Extended Renal Replacement Therapy. Continuous / Extended Renal Replacement Therapy applies to devices with FDA clearance to perform IAW SOW Section 5. VA makes no reference to "trademark" in this requirement. | |
| RFP | Page 84, C.1. (a)(1) | What is a reasonable time? Any historical precedence for information? | The FAR does not specify the definition of reasonable time in 52.212-4 (a)(1) | |
| RFP | Page 89, C.2 52.216-18 ORDERING | Is this date range still accurate? Can orders be issued prior to the contract award date? | Modified RFP: The clause has been updated to state orders can be issued at contract award. | |
| RFP | Page 93, C.7. VAAR 852.212-70 | What, if any, EPA actions/requests can a vendor make based upon raw material pricing changing over the life of the contract? | EPA clauses are not included in this procurement. | |
| RFP | A recent Biden executive order for social economic adjustment effective January 30, 2022, requires some federal contractors to raise minimum wage to $15/HR. Question: Will this be a requirement incorporated into this contract? If so, will economic price adjustments be allowed to help support the increase in operational costs? | EPA clauses are not included in this procurement. | ||
| RFP | Page 103, C.12.6.c. | With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. Request clarification on a situation where the contractor/subcontractor, “should have known of a breach of such information”. Seeking a better definition or will it be contained in any anticipated BAA or in current VA information security documentation? | These requirements, when applicable, will be documented and defined in a Business Associate Agreement between the VA and the vendor post contract award. The BAA would be required under certain circumstances where PII/PHI is a factor. The VHA Privacy Office would guide the BAA process post contract award. | |
| RFP | Page 105, C.12.9.b | The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. | ||
| Subcontractor has hundreds of employees, can additional time be provided for completing training certificates and certification of signing the Contract Rules of Behavior following the initiation of the contract? | As this section only applies to contractor employees and subcontractor employees requiring access to VA information and VA information systems, it should only affect a small number of contractor and subcontractor employees that require this access. That subgroup shall complete the referenced requirements before being granted access to VA information and its systems. | |||
| RFP | Will a separate leasing agreement be included in any contract award (for home hemodialysis system)? Can a vendor submit proposed leasing language with their solicitation response? | A leasing agreement will be included in contract award. A vendor may submit proposed leasing language. VA is not obligated to accept that language. | ||
| RFP | Will 52.232-25 Prompt Payment and 52.213-1 Fast Payment Procedure apply to SDVOSB companies in the invoicing/payment procedures and processes? | Federal Government invoicing standard is Net 30 | ||
| MTR | Page 9, h. | We recommend and request the below wording to be modified to: “Continuous Extended Renal Replacement Therapy (CRRT) System” in order to provide VA the greatest leeway in evaluating offered product against this criteria. | Modified SOW Section 5h: Continuous / Extended Renal Replacement Therapy. | |
| MTR | Page 10, j. | What qualifies as lightweight? Does a carrying case refer to a shipping crate? What if manufacturer eliminated the cart and carrying case in order to decrease cost and complexity for care giver and patients? What if the dialysis system is mobile and is capable of easy and safe movement within a space and/or easily transported because of the mobile nature of the product; i.e. inherent product design? | Lightweight indicates that the system mobility shall be manageable by a patient. A carrying case does not refer to a shipping crate. A carrying case may not be applicable for all systems. | |
| MTR | Page 11, k. | What qualifies as lightweight? Does a carrying case refer to a shipping crate? What if manufacturer was able to eliminate a cart and carrying case in order to decrease cost and complexity for care giver and patients? What if the dialysis system is mobile and is capable of easy and safe movement within a space and/or easily transported because of the mobile nature of the product; i.e. inherent product design? | Lightweight indicates that the system mobility shall be manageable by a patient. A carrying case does not refer to a shipping crate. A carrying case may not be applicable for all systems. | |
| SOW | Page 7, o | Is it therefore safe to assume that, facilities who decide on purchasing Outset’s Tablo technology can disregard? | The Universal Requirements Section of the SOW applies to all Systems, Services, and Consumables, including Outset's Tablo technology. | |
| SOW | Page 12, y | To factor in freight, are we able to provide OCONUS pricing separate from CONUS pricing (to factor in higher freight costs into the system price for OCONUS, and not impact pricing to CONUS facilities)? If not, can we provide freight cost at time of order? | A CONUS versus OCONUS rate is acceptable. | |
| SOW | Page 9, h.4 | We recommend the below wording be modified to: “Shall include all components of the hemodialysis system in one portable device including blood pump and tubing, heparin pump and syringe holder pre filter and post-filter infusion ports, blood pressure sensors, blood pressure cuff, dialysate pump, bicarbonate connector, membrane, lockable wheels, manual hand crank.” | Modified SOW Section 5f: Shall include all components of the hemodialysis system in one portable device including blood pump and tubing, heparin pump and syringe holder pre filter and post-filter infusion ports, blood pressure sensors, blood pressure cuff, dialysate pump, bicarbonate connector, membrane, lockable wheels, manual hand crank. | |
| Universal Requirements | Page 7, s.2 | a. | Is home veteran expected to use USB device for prescription? Or is prescription expected to transfer over the connected (WiFi or Ethernet) Tablo device? | |
| b. | We assume VA/Home veteran would be responsible for providing adequate connectivity for Tablo device. Request confirmation. | |||
| c. | When Tablo devices are moved among VA locations or different veteran's home, Outset requires that VA informs about location and patient using the specific Tablo device. Request confirmation. | |||
| d. | Outset identifies treatment using MRN#. Please confirm that VA will have an appropriate process in place to always input correct MRN# for the prescription. | |||
| a. It is expected that a USB device will be used for prescriptions as well as transfer of prescriptions over the connected Tablo device, To Be determined by the VA in conjuction with the vendor. b. VA is responsible for providing adequate connectivity IAW SOW Section 4g. c. VA will provide location and patient notification as Tablo devices are transferred to/from veterans/locations. d. VA will have an appropriate process in place for MRN accounting. |
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