The VA Pittsburgh Healthcare System (VAPHS) intends to negotiate on a Sole Source basis with NxStage Medical, Inc., 439 S. Union Street, 5th Floor, Lawrence, MA 01843, to award a Multiple Year (Base and Two Option Year) contract to them, to furnish NxStage Medical, Inc. Hemodialysis supplies, and deliver them directly to VAPHS patient's homes to be used with NxStage Dialysis Machines that are in patient's homes, and perform ancillary services to assure proper dialysis treatment. It is essential to purchase the following NxStage Medical, Inc. supplies, and to purchase them from NxStage Medical, Inc., for the reasons stated in the attached Sole Source Justification Memorandum. Total Est. Annual Amount: $76,800 Total Base and Two Option Year contract amount: $230,400. Estimated Period of Performance: Base Year: 9/30/2015 through 09/29/2016 Option Year One: 9/30/2016 through 09/29/2017 Option Year Two: 09/30/2017 through 09/29/2018 List of items that can be purchased and Scope of Work: PF-17-N-6-SUP 6x week 17L PF-20-N-4-SUP 4x week 20L PF-20-N-5-SUP 5x week 20L PF-20-N-6-SUP 6x week 20L PF-20-N-7-SUP 7x week 20L PF-20-N-E-SUP EOD 20L PF-25-N-4-SUP 4x week 25L PF-25-N-5-SUP 5x week 25L PF-25-N-6-SUP 6x week 25L PF-25-N-7-SUP 7x week 25L PF-25-N-E-SUP EOD 25L PF-30-N-4-SUP 4x week 30L PF-30-N-5-SUP 5x week 30L PF-30-N-6-SUP 6x week 30L PF-30-N-7-SUP 7x week 30L PF-30-N-E-SUP EOD 30L PF-35-N-4-SUP 4x week 35L PF-35-N-5-SUP 5x week 35L PF-35-N-6-SUP 6x week 35L PF-35-N-E-SUP EOD 35L PF-40-N-4-SUP 4x week 40L PF-40-N-5-SUP 5x week 40L PF-40-N-6-SUP 6x week 40L PF-40-N-E-SUP EOD 40L PF-50-N-4-SUP 4x week 50L PF-50-N-5-SUP 5x week 50L PF-50-N-6-SUP 6x week 50L PF-50-N-E-SUP EOD 50L PF-60-N-4-SUP 4x week 60L PF-60-N-5-SUP 5x week 60L PF-60-N-6-SUP 6x week 60L PF-60-N-E-SUP EOD 60L Part # Tx Freq & Volume Discount off Contract Price EXPRESS (Bags) for the NxStage System One EX-15-N-4-SUP 4x week 15L EX-15-N-5-SUP 5x week 15L EX-15-N-6-SUP 6x week 15L EX-15-N-7-SUP 7x week 15L EX-15-N-E-SUP EOD 15L EX-20-N-4-SUP 4x week 20L EX-20-N-5-SUP 5x week 20L EX-20-N-6-SUP 6x week 20L EX-20-N-7-SUP 7x week 20L EX-20-N-E-SUP EOD 20L EX-25-N-4-SUP 4x week 25L EX-25-N-5-SUP 5x week 25L EX-25-N-6-SUP 6x week 25L EX-25-N-7-SUP 7x week 25L EX-25-N-E-SUP EOD 25L EX-30-N-4-SUP 4x week 30L EX-30-N-5-SUP 5x week 30L EX-30-N-6-SUP 6x week 30L EX-30-N-7-SUP 7x week 30L EX-30-N-E-SUP EOD 30L EX-35-N-4-SUP 4x week 35L EX-35-N-5-SUP 5x week 35L EX-35-N-6-SUP 6x week 35L EX-35-N-E-SUP EOD 35L EX-40-N-4-SUP 4x week 40L EX-40-N-5-SUP 5x week 40L EX-40-N-6-SUP 6x week 40L EX-40-N-E-SUP EOD 40L EX-45-N-4-SUP 4x week 45L EX-45-N-5-SUP 5x week 45L EX-45-N-6-SUP 6x week 45L EX-45-N-E-SUP EOD 45L Part # Tx Freq & Volume Discount off Contract Price PureFlow SL for the NxStage System One S^ HF-20-N-4-SUP 4x week 20L HF-20-N-5-SUP 5x week 20L HF-20-N-6-SUP 6x week 20L HF-20-N-E-SUP EOD 20L HF-20-N-O-SUP 2 On 1 Off 20L HF-25-N-4-SUP 4x week 25L HF-25-N-5-SUP 5x week 25L HF-25-N-6-SUP 6x week 25L HF-25-N-E-SUP EOD 25L HF-25-N-O-SUP 2 On 1 Off 25L HF-30-N-4-SUP 4x week 30L HF-30-N-5-SUP 5x week 30L HF-30-N-6-SUP 6x week 30L HF-30-N-E-SUP EOD 30L HF-30-N-O-SUP 2 On 1 Off 30L HF-40-N-4-SUP 4x week 40L HF-40-N-5-SUP 5x week 40L HF-40-N-6-SUP 6x week 40L HF-40-N-E-SUP EOD 40L HF-40-N-O-SUP 2 On 1 Off 40L HF-50-N-4-SUP 4x week 50L HF-50-N-5-SUP 5x week 50L HF-50-N-6-SUP 6x week 50L HF-50-N-E-SUP EOD 50L HF-50-N-O-SUP 2 On 1 Off 50L HF-60-N-4-SUP 4x week 60L HF-60-N-5-SUP 5x week 60L HF-60-N-6-SUP 6x week 60L HF-60-N-E-SUP EOD 60L HF-60-N-O-SUP 2 On 1 Off 60L SAK-401 Consumables PureFlow SL SAK, 60L Lactate 45 mEq/L, 1K^ SAK-402 Consumables PureFlow SL SAK, 60L Lactate 40 mEq/L, 1K^ SAK-403 Consumables PureFlow SL SAK - 50L Lactate 45 mEq/L, 1K^ SAK-404 Consumables PureFlow SL SAK - 60L Lactate 45 mEq/L, 2K^ SAK-405 Consumables PureFlow SL SAK - 40L Lactate 45 mEq/L, 1K^ SAK-406 Consumables PureFlow SL SAK - 50L Lactate 45 mEq/L, 2K^ SAK-407 Consumables PureFlow SL SAK - 50L Lactate 40 mEq/L, 1K^ NC4012* Documentation NxStage System One and NxStage System One S Chronic Cycler Users Guide NC5342* Documentation PureFlow SL User Guide for System One S^ STATEMENT OF WORK FOR HOME HEMODIALYSIS: (1) Background: Dialysis, required as a life-sustaining treatment for End Stage Renal Disease (ESRD), is a service provided by VA Pittsburgh Healthcare System (VAPHS) as part of the veterans medical benefits package described in Title 30 of the Code of Federal Regulations (38 CFR 17.38). Short daily dialysis is a renal replacement treatment option associated with a decreased number of side effects and a higher quality of life for patients. Travel to the VAPHS dialysis unit 5-6 days per week is a hardship for many patients and short daily dialysis is often performed at home. Home hemodialysis equipment must be designed for ease of set up, training, and use, must plug into a standard electrical outlet and drain without plumbing changes, and must function without a separate water purification system. In addition, the dialysis equipment must be compact, lightweight, and portable so that the patients may have the freedom to travel with their dialysis equipment. The company should provide products such as carrying cases and pre-packaged, pre-mixed dialysate. Therefore, VAPHS requires a contract for supplies and accessories (including training) for the Nxstage System One and Pureflow SL which are separately purchased by VA Prosthetics Dept (as durable medical equipment) for VAPHS patients in the renal dialysis home program, pursuant to appropriate clinical prescription. The supplies and accessories included in the Schedule of Supplies and Services within will be ordered and shipped directly to veteran patients at their homes. (2) Contractor Responsibilities- general: A. Supplies and Accessories: The contractor will provide all supplies, accessories, and education components, needed to permit successful execution of home hemodialysis by the patient in their home (see Schedule of Supplies or Services and Prices/Costs). In order to facilitate this process, the contractor will, at a minimum, provide all materials required to perform home hemodialysis including expendable supplies and accessories delivered directly to the patient's home on a regular (as need) schedule. Supplies will be delivered on a monthly basis. Medical staff and patients will have 24/7 access to company representatives for clinical and technical advice. B. Supplies and Accessories: The contractor will provide all Nxstage System One and Pureflow SL supplies and accessories needed to permit successful execution of home hemodialysis training by patients who will train at the VAPHS dialysis clinic when necessary. Medical staff will have 24/7 access to company representatives for clinical and technical advice. C. The contractor must offer 24/7 expert clinical, technical, and customer support services to the patient. They must also offer a 24/7 swap program whereby malfunctioning or non-functioning equipment is replaced immediately so that missed hemodialysis treatments are minimized. D. The contractor must also provide training and support to the dialysis unit staff. They must provide on-site clinical training to the dialysis unit physicians and nurses on the proper use, maintenance, and troubleshooting of the dialysis equipment. Any time there is an upgrade or change to the equipment, the company must return on-site to educate and train the staff. They must provide the dialysis unit with high quality training and educational materials in order for the staff to most effectively train the home hemodialysis patients. The company should also provide the dialysis unit with sample program materials such as flow sheets, polices, procedures, and orders to streamline the home hemodialysis program implementation process. (3) FDA Requirement: The contractor will provide dialysis equipment (through Prosthetics) that has met FDA requirements and obtained FDA approval for home use. (4) All-inclusive source: All items required for home hemodialysis will be provided under the contract inclusive of expendable supplies and accessory items, and Nxstage System One and Pureflow SL equipment may be ordered for delivery to the VAPHS. (Nxstage equipment for home use will be separately purchased by VA Prosthetics Dept. as in (1) above). All supply and accessory items will be delivered directly to the patient's home. (5) Invoices: Invoices shall be submitted in arrears, monthly. The Contractor will submit invoices covering the supplies provided under this contract. Sums due the Contractor will be paid upon receipt of properly prepared invoices. Invoices for payment should be submitted in the following manner: 1. Submitted monthly per patient 2. Should include invoice number, contract number, and purchase order number. 3. Should include patient's name, separate line items listed and date of order. 4. Line item information should include: item number, name, description, quantity, unit cost and total cost as described below. Date Item # Item Desc. Quantity Unit Cost Total Cost (6)Delivery and set-up: Supplies and accessories (A) are delivered directly to the home. They are brought inside and stacked in a room, closet, garage, etc by the vendor. All supplies, regardless of amount, will be brought inside of the patient's home. Any fees required for this service will be paid by VAPHS. Equipment, supplies and accessories (B) are delivered directly to the VAPHS. (7) Patient Education and Support: Contractor will provide VA staff with high quality training and educational materials in order for VA staff to most effectively train the home hemodialysis dialysis patients. Upon award, the contractor will provide the VA Dialysis unit with appropriate support materials which it has developed and utilizes for consistency and QA; such as flow sheets, policies, procedures, supply order forms, and physician orders, in order to streamline the home program. (8) VAPHS Staff Education: The contractor must provide training and support to the dialysis unit staff. Upon contract award, the Contractor's proposed training program content will be reviewed by the Nurse Manager and the Section Chief of Renal. All materials must meet with the approval of both persons before the content will be considered acceptable. The training must occur at the University Drive campus, VA Pittsburgh Healthcare System. Training will be comprehensive and should include all aspects of set-up, use, maintenance, cleaning, troubleshooting, and reference materials. Any time there is an upgrade or change to the equipment, the contractor must return on-site to educate and train the staff. (9) Term of Contract: This contract is effective April 1, 2014 (or date of award, if later) through March 31, 2015. The Contracting Officer reserves the right to exercise two (2) one-year option periods. The contract is subject to the availability of VA funds. (10) Contract Monitoring Procedures: Performance will be evaluated and monitored by the VAPHS Home Dialysis Program Coordinator (currently Tina Ward, BSN, RN-BC). The VA official responsible for verifying contract compliance and verifying invoices is the COR for Medicine Service Line (currently Kaneen Allen, Business Manager). The COR will furnish a statement in writing to the Contracting Officer at close out of the contract to include a summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed. A summary evaluation of contractor performance, based upon the compliance or noncompliance of contract requirements as evidenced in the monitoring procedures shall be forwarded by the monitoring official to the Contracting Officer prior to exercising any option year. This Notice of Intent is not a request for competitive proposals. Parties may identify their interest; accompanied by supporting literature, to the Contracting Officer no later than 4:00PM on 09/21/2015. Responses should be sent to both
[email protected] and
[email protected]. No telephone responses will be accepted. Information received will be for the purpose of determining whether or not to conduct a competitive procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer. The NAICS Code for this procurement is 339112, and the Small Business Size Standard for this NAICS Code is 500 employees. Contracting Office Address: Attn: Department of Veterans Affairs Pittsburgh Healthcare System, Contracting Officer, 1010 Delafield Road, (90C-A), Pittsburgh, Pennsylvania 15215-1802 Point of Contact (s): Ronald Mazzei, Contract Specialist. Phone 412-822-3770. Michael J. Lamb, Contracting Officer. Phone 412-822-3766.