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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 17, 2016 FBO #5168
DOCUMENT

65 -- Peritoneal Dialysis System - Attachment

Notice Date

1/15/2016
 

Notice Type

Attachment
 

NAICS

334510 — Electromedical and Electrotherapeutic Apparatus Manufacturing
 

Contracting Office

U.S. Department of Veterans Affairs;Strategic Acquisition Center;10300 Spotsylvania Ave;Fredericksburg VA 22408
 

ZIP Code

22408
 

Solicitation Number

VA11916Q0096
 

Response Due

2/11/2016
 

Archive Date

4/11/2016
 

Point of Contact

Maurice D. Christian
 

E-Mail Address

work
(maurice.christian@va.gov)
 

Small Business Set-Aside

N/A
 

Description

The Department of Veterans Affairs (VA) Strategic Acquisition Center (SAC) intends to solicit a five year Firm-Fixed Price (FFP) multiple-award Blanket Purchase Agreement (BPA) for leasing of Peritoneal Dialysis System (PDS) and dialysate solutions. The NAICS code for this acquisition is 334510, Electromedical and Electroterapeutic Apparatus Manufacturing. Further information will be provided in solicitation VA119-16-Q-0096, which is anticipated to be posted on Federal Business Opportunities (FBO) on or approximately 2/1/2016. Any firm wishing to submit comments/concerns should email Maurice Christian at maurice.christian@va.gov and Brian Love at brian.love@va.gov. STATEMENT OF WORK AND/OR OTHER TERMS AND CONDITIONS FOR PERITONEAL DIALYSIS SYSTEMS 1.0BACKGROUND The Department of Veterans Affairs (VA) has a need for a national contractual vehicle that will allow for the lease of Peritoneal Dialysis machines and purchase of compatible solutions and consumables used for renal replacement therapy. These devices are intended to treat renal failure, partially replacing kidney function by removing metabolic wastes and excess fluid through selective diffusion and osmosis across the peritoneum. These machines and associated solutions are used by the patients in the hospital, clinic and home settings. 2.0SCOPE The Contractor shall provide the Peritoneal Dialysis machine, under a lease agreement (also referred to as the Cycler), the required dialysates (solutions), and consumable products as purchased items. The Contractor shall provide delivery, set up (when indicated), technical support for patients and clinical staff, and clinician training for use of the System. The Contractor shall supply only the latest generation of Peritoneal Dialysis machines in compliance with the Food and Drug Administration (FDA) regulations for medical devices. In addition, the Contractor shall identify and update medical devices via a Technology Refresh program. The Contractor shall provide full maintenance (preventative, repair, and/or urgent replacement and terminal cleaning for returned equipment) for the Peritoneal Dialysis machines to make the systems fully functional for their intended use and to manufacturer's specifications. The Contractor shall provide initial and on-going training for operational use to doctors, clinicians, and biomedical staff at each site. The Contractor shall maintain an inventory of items leased to include certification for safety acceptance, all repair history and hours of use. The Contractor will provide 24/7 technical support for cycler issues. 3.0APPLICABLE DOCUMENTS The following references apply to this requirement and shall be adhered to by the Contractor on all items offered. 3.1CFR - Title 21-Food and Drugs, Chapter I-Food and Drug Administration, Department of Health and Human Services, Subchapter H-Medical Devices, Part 814-Premarket Approval of Medical Devices. 4.0REQUIREMENTS The Contractor shall deliver products and supplies to medical facilities and home dialysis patients as indicated in each delivery order. The contractor shall work from an established order and delivery scheduled that has set days identified. The Contractor shall deliver the appropriate supplies and equipment needed for peritoneal dialysis treatments. The Contractor shall ensure that all equipment and systems provided are fully operational to manufacturer's specification and free from defect. The Contractor shall provide the Peritoneal Dialysis Systems defined by the Minimum Technical Requirements (MTRs) identified in Appendix A, Peritoneal Dialysis Systems and Peritoneal Dialysate Solution Minimum Technical Requirements (MTRs). 4.1Program Management and Quality Control The Contractor shall ensure that all requirements in this Statement of Work (SOW) are met and shall provide quality control measures that ensure continued performance and schedule. The Contractor shall ensure all medical devices, products, supplies, consumables and materials are approved in accordance with the pre-market notification process under the Food and Drug Administration (FDA) 510K Program and labeled accordingly. Contractor shall report all recalls, removals, modifications and safety notices from the manufacturer, distributor and FDA, and provide immediate notice (within 48 hours) to the Contracting Officer and the facility point of contact and the VHA Product Recall Office for any notices identified for medical devices, products, supplies, consumables and materials. 4.2Inspection and Acceptance The Contractor shall provide Peritoneal Dialysis Systems (supplies and machine) directly to the patient or as applicable to the ordering medical facility. The Contractor shall notify VA Logistics or facility appropriate contact 3 days prior to delivery and arrival to a facility. 4.3Operating Manuals The Contractor shall provide 508 compliant manual (digital format) covering full operational use (in language understood by patients and healthcare professionals). The Contractor shall ensure that manuals include the care, handling, set-up, and cleaning of all Peritoneal Dialysis Systems. 4.4Service or Repairs The Contractor shall provide exact loaner/replacement cyclers as needed by each medical facility or shipped to the patients' home, within 1 business day following request for service and repairs by either the VA or the dialysis patient. The Contractor shall provide their most current contact information to medical facilities and the at home patient. Contact information shall be provided for a 24 hours/7 days (including all holidays) contact line or point of contact incase, VA or patients may need to seek immediate resolution regarding repairs or maintenance. If the Contractor's technical personnel are not available to address concerns at the time contact has been initiated, technical personnel are required to provide a response within 3 hours of the service call. 4.5Preventative Maintenance The Contractor shall provide the VA with written documentation, user manuals, and standard operating procedures that are consistent with guidelines set by the Joint Commission, and Association for the Advancement of Medical Instrumentation (AAMI) to ensure proper routine cleaning of all Peritoneal Dialysis Systems. 4.6Product Removal, Recall and Safety If any medical device, product, supplies, consumables or materials provided under contract requires modification (including instructions for use), is removed, recalled or issued a safety notice by the Contractor, manufacturer, or if any required modification, removal, recall, or safety notice is suggested or mandated by a regulatory or official agency (e.g., FDA), the Contractor shall immediately notify the Contracting Officer and each facility POC via email, or by the most expeditious manner possible. Notification contents shall include, but not be limited to: 1.Complete item description and/or identification (e.g., serial numbers, lot numbers, expiry dating), order numbers from customers, and the contract number assigned as a result of an award on this solicitation. 2.Reasons for modification(s), removal, recall or safety notice. 3.Necessary instructions in order to obtain return for credit, replacement or corrective action. 4.A list of all agencies and/or VA facilities notified. In addition, the Contractor will provide a written corrective action plan which shall be taken by the Contractor if the above should occur within 7 calendar days of receipt of such notification. Any product recalled or removed from use by the Contractor, manufacturer or regulatory agency (e.g., FDA) for any reason, shall be returned to, and replaced by the Contractor or manufacturer at no cost to the facility. Should any product under this contract become unavailable, back ordered, either temporarily or permanently, the Contractor shall provide the facility with 24 hour notification thereof, offering possible substitutions and/or alternative sources, to afford the facility adequate opportunity to approve or reject offered substitution and/or make other procurement arrangements. In addition to the aforementioned parties being notified the contractor must also notify the VHA Product Recall Office at the below address: Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 4.7Technology Refresh Technology refresh requirements are applicable to the BPA only and not the orders/leases thereunder. All devices offered shall be state-of-the-art technology at the time of initial delivery for each order/lease. "State-of-the-art" is defined as the most recently designed components that are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the solicitation. Products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. If upgrades of devices, new accessory devices, or software become available after award of this BPA or an order/lease the contractor may add or substitute them for the awarded items following evaluation and approval by the Contracting Officer of Record and/or designee upon mutual execution of a modification to this BPA. The contractor shall provide to the contracting officer the following information prior to the end of the BPA annual review. A list of specific awarded items that shall be added or updated. Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/ disadvantages of the items involved. The Contracting Officer will provide the information to his or her designee for review and approval. Upon approval, the contract will be modified at the end of the annual review to acknowledge the updated items. 4.8Patient Prescriptions The Contractor shall supply only those products and supplies medically prescribed by the authorized Department of Veteran Affairs provider(s) and indicated on the delivery order. The Contractor shall establish a method to identify the specific items to be delivered for each patient on an ordering form or electronic ordering process. 4.9Ordering Procedures The Contractor shall perform in the manner consistent with standard business subject to, but not limited to or by, the requirements of this section and/or any other section of the awarded contract, or as otherwise directed by the Contracting Officer his/her authorized representative, as applicable and appropriate. All orders will be placed on an as needed basis, either in writing or by phone (followed up in writing) from the Contracting Officer's Representative (COR) or facility dialysis department ordering official. The Contractor shall not substitute any items and shall not increase or decrease quantities ordered. Order numbers will be provided by each facility at the time the order is placed. Home peritoneal dialysis patients may work with the vendor to establish appropriate ordering of peritoneal dialysis supplies, with a purchase order being obtained prior to supply order finalization. Purchase Order Numbers will be provided by each ordering facility directly to the Contractor prior to placing any orders. The Contractor shall invoice each facility individually citing the facility name, location, purchase order number and account number. Facilities will verify deliveries by developed or developing standard internal procedures. Facilities are not authorized to enter into any additional agreement, contract, or understanding with the Contractor. Only the Contracting Officer has the authority to make changes to the terms and conditions of the contract and will be made only by written agreement by both parties in accordance with FAR 52.212-4(c). 5.0PICK-UP, RETURN, AND CREDIT OF UNUSED/DAMAGED SUPPLIES Due to the nature of these supplies, the contents are subject to damage in transit. All orders must be counted and inspected for damage prior to acceptance of delivery from carrier. Exception will be noted on the freight bill. The driver will countersign the freight bill. Exceptions must be reported within two (2) business days to the Contractor's designed customer service representative in order to receive all authorized credits. All returns must be arranged through the Contractor's customer service department. All products returned to the contractor must have a Return Good Authorization (RGA) number. Any product returned without a corresponding RGA number shall not be credited. Disposables that have not been stored in a sanitary manner or in accordance with product storage statements cannot be returned or credited. Verification of proper storage may be required for credit. Disposables provided at no charge are not eligible for credit, but are still subject to the terms of this contract. Prior to notification and approval by the Contractor each facility is required to return any disposables that are eligible for credit. Requests for return must include an accurate count of product and must be accompanied by matching documentation (i.e. a delivery or invoice). Disposables shipped in error by the Contractor must be reported within five (5) business days and returned within thirty (30) days of shipment to receive one hundred percent (100%) credit. Disposables ordered in error by the facility will be reported within five (5) business days and returned within thirty (30) days of shipment to receive one hundred percent (100%) credit, with the exception of peritoneal dialysis solutions returned from home patients (which may not be returned for credit). All such returns must be arranged through the Contractor's customer service department. Disposables returned after thirty (30) days of shipment but within ninety (90) days of shipment shall be considered excess stock. Return of excess stock must be arranged through the Contractor's customer's service department and the Government will be responsible for return shipping. Disposables returned after ninety (90) days from shipment are not eligible for credit. Excess stock shall be eligible for return or credit under the following circumstances: a.Excess stock with less than three (3) months remaining to expiration may not be returned for credit. b.Excess stock returned from a hospital or center shall credited at fifty (50%). Excess stock returned from Home peritoneal dialysis patients; with the exception of peritoneal dialysis equipment (which may not be returned for credit) shall be credited at fifty percent (50%) only in the instances of death, transplantation, or permanent return to center. 6.0PACKAGING AND MARKING Items must be adequately packaged to prevent damage during shipping, handling and storage. Delivered products and supplies shall contain the complete contract number, order number and shipping address. The contract number will be provided upon award. Order number will be provided by each facility at the time the order is placed. A packing list/slip shall be enclosed with each shipment indication the order number, items, unit of issue, items/quantity ordered and items/quantity shipped. Packing list will not be placed on box as to cover the product description of the expiration dates. 7.0DELIVERIES OR PERFORMANCE Unless otherwise specified, all orders shall be delivered complete and within seven (7) to ten (10) calendar days with emergency deliver available for 24 hour shipment within the CONUS and 48 hours OCONUS after receipt of order. If an order cannot be delivered complete, or within the time frame arranged, the Contractor shall immediately notify the facility ordering official. Delivery may be rescheduled if it can be determined by the ordering official that patient care will not be disrupted. It is the responsibility of the Contractor to comply with the decision of the ordering official. The Contractor shall be responsible for delivery to the appropriate location in the U.S., Puerto Rico, Philippines and Guam specified by the ordering facility. This includes, but is not limited to, off-loading of delivery vehicle, and transporting/carriage to specific location (e.g. warehouse, office, room within a building/home, or other such site as directed). The Contractor shall provide the necessary means to accomplish such delivery, nor shall the Government be required to accept shipment should the Contractor or his designee is unable to make delivery as required. Furthermore, the Government assumes no liability nor shall incur any costs for reshipment due to the Contractor's or his designee's failure to deliver due to the non-availability of the necessary delivery equipment as exemplified herein. Home Delivery: When delivering supplies to a patient's home, upon receipt of the order, the Contractor shall contact the patient to arrange the day and time for delivery within the time frame(s) arranged by the ordering official. Deliveries shall be made to the patient's home in cooperation with the patient. Contractor delivery personnel shall obtain Proof of Delivery (POD) by having the home patient sign and date the delivery ticket. The Contractor shall not leave supplies, equipment or consumables without acceptance of delivery by the patient. The Contractor shall attach legible copies of the signed delivery tickets to the respective invoices submitted for billing. The Contractor shall rotate any existing stock to the front and place new stock behind. ? Appendix A. Peritoneal Dialysis Systems Minimum Technical Requirements (MTRs) PERITONEAL DIALYSIS SYSTEMS TECHNICAL SPECIFICATIONS:METHOD OF EVALUATION: Peritoneal Dialysis Cycler SAMPLES REQUIRED MTR 1Must be FDA approved per: Code of Federal Regulations Title 21Literature Review MTR 2Must have available equipment/supplies to perform continuous ambulatory peritoneal dialysis (CAPD) Literature Review MTR 3Must perform continuous cyclic peritoneal dialysis (CCPD)Literature Review MTR 4Must have options for programmable treatment modalities providing for daytime exchanges, nighttime cycling and fill/drain volume specificationsLiterature Review MTR 5Must be a portable unit that can be transported by the patientLiterature Review MTR 6Must have a stable power source and emergency backup power source for power outages Literature Review MTR 7Must be able to be used in the preferred type of settings: Hospital; dialysis clinic; home Literature Review MTR 8Vendor must provide a replacement system with a 24hours turn around Literature Review MTR 9Approx. weight (kg): 12-13Literature Review MTR 10Must be able to operate for (hours): 10-12 hours continuouslyLiterature Review MTR 11Provide documentation of Electromagnetic Compatibility compliant to the EIC 60601-1-2 standard Literature Review MTR 12Must have solution warming capabilities and a safety mechanism to prevent overwarming of solutionsLiterature Review MTR 13System must have an alarm system that detects maximum/minimum pressures within the internal circuitry, temperature parameters and low/high drain & fill volume Literature Review MTR 14System must have a protective system minimizing air infusionLiterature Review MTR 15System must have a protective system preventing increased intraperitoneal volume (IIPV)Literature Review MTR 16Must have a range fill volume of 0 to 3 itemsLiterature Review Intended Use: These devices are intended to treat renal failure, partially replacing kidney function by removing metabolic wastes through selective diffusion across the peritoneum. These devices consist of a machine that performs automated dialysis cycles or continuous cyclic peritoneal dialysis (CCPD) PERITONEAL DIALYSATE SOLUTION TECHNICAL SPECIFICATIONS:METHOD OF EVALUATION: Item: CAPD solutions TECHNICAL EVALUATION MTR 1Packaging states solution is sterile.Literature Review MTR 2Packing states one-time use only.Literature Review MTR 3Packaging states expiration date, lot number, and composition. Literature Review MTR 4Literature shows FDA approval.Literature Review MTR 52 Liters with 1.5% - 4.25% dextrose Literature Review MTR 92.5 Liters with 1.5% - 4.25% dextrose Literature Review MTR 113 Liters with 1.5% - 4.25% dextrose Literature Review MTR 14CAPD bags have prespike bag availabilityLiterature Review MTR 15Integrated drain line Literature Review MTR 16Low & Standard Calcium DialysateLiterature Review Intended Use: Provide Peritoneal Dialysis Systems used for renal replacement therapy. These are intended to treat renal failure, partially replacing kidney function by removing metabolic wastes and excess fluid through selective diffusion and osmosis across the peritoneum. PERITONEAL DIALYSATE SOLUTION TECHNICAL SPECIFICATIONS:METHOD OF EVALUATION: Item: CCPD solutionsTECHNICAL EVALUATION MTR 1Packaging states solution is sterile.Literature Review MTR 2Packing states one-time use only.Literature Review MTR 3Packaging states expiration date, lot number, and composition. Literature Review MTR 4Literature shows FDA approval.Literature Review MTR 52 - 6 liter bags, 1.5% - 4.25% dextroseLiterature Review MTR 6Low & Standard Calcium Dialysate Literature Review Intended Use: Provide Peritoneal Dialysis Systems used for renal replacement therapy. These are intended to treat renal failure, partially replacing kidney function by removing metabolic wastes and excess fluid through selective diffusion and osmosis across the peritoneum.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/ac27c78556702a5a3afc04eee7632106)
 

Document(s)

Attachment
 

File Name: VA119-16-Q-0096 VA119-16-Q-0096_Synopsis.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2510153&FileName=VA119-16-Q-0096-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2510153&FileName=VA119-16-Q-0096-000.docx

 

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Record

SN03993971-W 20160117/160115234242-ac27c78556702a5a3afc04eee7632106 (fbodaily.com)
 

Source

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