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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 19, 2013 FBO #4408
DOCUMENT

65 -- Regional Custom Packs - Attachment

Notice Date

12/17/2013
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Service Area Office, Central Region 10F;708 South Third Street;Suite 108E;Minneapolis MN 55415
 

ZIP Code

55415
 

Solicitation Number

VA240C14I0003
 

Response Due

12/27/2013
 

Archive Date

2/10/2014
 

Point of Contact

Nicole Lindstrom
 

Small Business Set-Aside

N/A
 

Description

REQUEST FOR INFORMATION (RFI) FOR CUSTOM SURGICAL PACKS THIS NOTICE IS NOT A REQUEST FOR PROPOSAL (RFP), BUT AN ANNOUNCEMENT OF AN INDUSTRY DAY(S). There is no commitment by the Department of Veterans Affairs (VA), SAO Central Region to issue a solicitation, make an award, or to be responsible for any monies expended by any interested parties in support of this effort. The Department of Veterans Affairs is neither committed nor obligate to pay for information provided, and no basis for claims against VA shall arise as a result of a response to this request for information. SAO Central Region Custom Sterile Surgical Packs Industry Day (One-on-One Sessions) Date/Time: Tuesday, January 7, 2014 - 1:00PM - 5:00PM Wednesday, January 8, 2014 - 8:00 M - 5:00PM Thursday, January 9, 2014 - 8:00AM - 1:00 PM Location: Embassy Suites Indianapolis Downtown 110 W. Washington Street Indianapolis, IN 46204 Description: The Industry Day(s) is being conducted in accordance with Federal Acquisition Regulation (FAR) 15.201(e) as part of market research as a forum to discuss with small and large businesses and to obtain feedback on acquisition strategies related to the SAO Central Region Custom Surgical Pack program. The objective of the Industry Day is to obtain input from industry representatives with expertise in and knowledge for implementation and management of a custom procedure surgical pack program. In addition, the Industry Day Conference is to provide preliminary information on SAO Central Region's anticipated technical requirements, business/contract considerations, acquisition approach as well as allowing each contractor the opportunity to express their technical, contractual and procedural concerns in regards to the Custom Surgical Pack program, requirements, and acquisition strategy. The Industry Day Conference will also provide an opportunity for contractors to ask questions and for interested firms to network with each other. One-on-One Sessions: VA will conduct forty-five minute one-on-one meetings with contractors. Participants are encouraged to bring samples, with the understanding that the participants are responsible of disposing of the samples that are provided. Each contractor shall provide one (1) written copy of their entire presentation to the following address NLT January 2, 2014 at 2:00 pm CST: Department of Veterans Affairs SAO Central Region ATTN: Custom Sterile Surgical Pack Team 708 S. Third Street Suite 108E Minneapolis, MN 55415 Registration Requirements: Companies of all sizes are invited, registration to attend Industry Day(s) is mandatory. Registration will begin on Tuesday, December17, 2013 and will end on or before Friday, December 27, 2013 by 2:00 pm (CST). Due to budgetary and time restrictions, only the first 25 contractors to register will receive one-on-one meetings. Registration may end prior to Friday, December 27, 2013 if full capacity is reached. Registration will be handled on a first come, first served basis. Vendors will not be allowed to register on the day of the event or be permitted to attend a session without a reservation. Reservations are not transferable. Registration to attend must be completed via email to VHACOSAOCentralRegionContractStaff@va.gov. Please provide your name, organization/company, phone number, number of attendees (limited to 4), and email address. Please note, attendance/participation at the Industry Day Conference is encouraged, but is not a prerequisite for participation in any solicitation that may eventually result from the conference. Please do not attend without confirmation of a reservation. The reservation confirmation will only be provided from the above noted email addresses. All questions regarding the Industry Day Conference should be directed in writing via email to Nicole Lindstrom at nicole.lindstrom@va.gov or Julie Willie at julieann.willie@va.gov. Requirements (Draft): A. The Contractor shall provide for each custom pack a lot number to allow for clear tracking of all packs and products. The Contractor shall insure that the manufacturer and lot number of each component item is traceable. The Contractor shall provide copies of the standard operating procedures governing batch control, product tracing, component manufacturing lot numbering, and written policies and/or procedures on component recalls. (1) Association for Advancement of Medical Instrumentation (AAMI) must validate the sterilization process. This validation must be performed, at a minimum, annually. The validation must be sent to the Contracting Officer upon annual inspection. (2) Component bioburden, sterility tests, and residual tests are to be performed by contract laboratories at contractor's expense. (3) Prior to sterilization, products shall be assembled in controlled rooms, which are open only to authorized personnel with proper attire. (4) Pack assembly shall be performed inside an environmentally controlled, limited access room. The room shall be maintained under positive air pressure and all surfaces cleaned minimally every two hours or as designated by local facility requirements. The Contractor shall have a sanitation program that monitors levels of microbial contamination regularly. (5) All aspects of the assembly, packaging and sterilization must adhere to the quality control standards set by the FDA. The Contractor must be registered with the FDA. (6) The Contractor assumes the responsibility and liability for the sterility and quality of the product when properly used and handled by the Government. (7) Re-sterilization of any product is prohibited. (8) The Contractor must have in-house sterilization capability or have, as a minimum, two (2) contract sterilization partners. The in-house or contract sterilization partners must be ISO9001:2000 (International Organization for Standardization) certified and undergo routine FDA inspections. (9) All component products shall be inspected upon arrival at the Contractor's plant and checked for damage and unacceptable expiration dates. (10) Contractor is responsible to have continual maintenance performed on all sterilizing equipment. (11) Quality assurance staff shall include personnel familiar with operating room procedures, infection control practices, aseptic techniques and sterilization methods. Verification documentation shall be provided with proposal. B. Component Parts: Components are listed as DO NOT SUBSTITUTE due to the requirements of the specific medical center staff and are required due to the specific instruments currently being used in the operating room or other circumstances. The substitution or changing of these specific items would require the changing of instruments or equipment in order to utilize the substitute of an alternative item. (1) Should an equal product be substituted in lieu of that specified, the product line must specify which item is equal and substituted for which item and be approved by the medical center prior to substitution. If no substitution of an equal product is offered, it will be presumed the offeror will provide the pack as specified. (2) All component items required for the tray/pack are to be provided by the Contractor. (3) All packs are to use hard white plastic base trays and components parts to reduce ETO (Ethylene Oxide) residue and eliminate possible particulate contamination from Styrofoam. ETO tape/indicator is to be affixed to the outer wrap and tray where applicable. All packs are to be double wrapped and to be provided with an additional plastic over wrap (gas pouch). This over wrap is to be considered a dust cover only. (4) Quantitative data must be available to show that the materials for surgical gowns and drapes provide an effective barrier to microbes. The materials must meet the American Society for Testing and Materials (ASTM) requirements for barrier protection, including blood borne pathogens, microbial challenge, as well as hydrostatic pressure with resistance to tears, abrasion and stains. All materials must be lint-free and meet or exceed the requirements of the National Fire Protection Regulations for flammability in Part 1610 of the Code of Federal Regulations. (a) Materials shall be of a soft, memory-free type that precludes shifting of drapes. (b) Material shall be non-abrasive and free of toxic ingredients, non-fast dyes and noxious odors. (c) Materials shall be non-glare and of a color that minimizes distortion from reflected light. (d) Gowns shall fit and allow freedom of movement. Gowns shall have stockinet cuffs, raglan sleeves and welded or stitched seams. (e) Gowns and drapes shall maintain an environment appropriate to body temperatures. (5) When cloth towels are specified, they are to be absorbent, disposable or towels made of 100% cotton, pre-washed with x-ray detectable loop. (6) All components must be Latex Free unless specified otherwise by the using facility. All packs must be labeled on the outside covering that the pack is Totally Latex Free. (7) Recalls: The Contractor shall have a documentation system for component product trace ability and lot number recordings for product recalls. The Contracting Officer must be notified immediately by telephone (with written notice to follow within five (5) calendar days) if affected by a product recall. If the recalled component is unavailable for further production of the custom pack(s), no substitutions will be made by the Contractor without written authorization of the Contracting Officer. C. Unavailability of Component Parts: Should a component part become unavailable which will temporarily or permanently delay the production of the pack(s), the Contractor shall immediately notify the Contracting Officer's Representative (COR) and the Contracting Officer by telephone (with written notice to follow within five (5) calendar days) of the situation and the anticipated length of delay. No deletions or substitutions will be made without written authorization from the Contracting Officer. If it is necessary and authorization is obtained to substitute a component, the substitution must be of the same or greater quality and will be at no additional cost to the Government. If the component will be out of stock for a prolonged period of time and the using service chooses to have the pack assembled without the product, written authorization must be given by the Contracting Officer. The cost of the pack must be adjusted to reflect the change. D. Packaging: Unless otherwise specified in the specification, the product shall be packed in substantial containers of the type, size and kind commonly used within the industry for this purpose. The container(s) will be constructed as to insure acceptance and safe delivery by common carriers, at the lowest rate, to the point of delivery designated by each facility. Items must be packaged adequately to prevent deterioration and damage during shipping, handling and storage. All packs must be labeled on the outside as Totally Latex Free. (1) Each pack shall have a label specifying the manufactured date of the pack and the expiration date of any dated products. This label, located inside of each pack, shall also contain an itemized listing of all components, including quantities. (2) All outer packages must contain the complete contract number and delivery order number in addition to the shipping address. The contract number will be provided upon notice of contract award. A delivery order number will be assigned by each participating facility for the fiscal year, annually or per order, during the life of the contract. (3) A packing list/slip shall be enclosed with each shipment indicating the contract number, delivery order number, items and quantity ordered and items and quantity shipped. (4) Any pack determined to be defective (e.g. contains expired components, sterility has been compromised, etc.), through no fault of the Government, shall be returned to the Contractor at the Contractor's expense. Full credit or replacement shall be made to the Government. Quality Assurance: A. The Custom Sterile manufacturing facilities must be registered and in good standing with The Food and Drug Administration and ISO9001:2000 certified (International Organization for Standardization). ISO, CEN (European Committee for Standardization), AAMI (Association of the Advancement of Medical Instrumentation), and AORN (Association of Operating Room Nurses) are other Industry standards that must be met. Per FAR 25.4, Trade Agreements, each end product is certified as a U.S.-made, designated country, Caribbean Basin country, or NAFTA country (Canada or Mexico) end product. B. A "Quality System Program" to prevent non-conformances at all product/service stages from design through distribution must be utilized. It is designed to comply with the requirements of ISO9001:2000 (International Organization for Standardization), 21 CFR 820 (Code of Federal Regulations), EN 46001 (European Nations Quality Standards), and United States regulations regarding the sales and distribution of medical products. C. The Custom Sterile Surgical Pack program must provide certain measures in the manufacturing of the kits. 1) Product specifications including video images, bills of material, biological evaluations, component specification, and identification of critical design and process parameters. These include how the parameter is to be met. 2) Production process specifications, including the appropriate equipment specification, production methods, production procedures, compatibility of the design with current systems and equipment. 3) Quality assurance procedures and specifications, i.e., quality plan, including quality assurance checks used and the quality testing apparatus, fixtures, resources, skills, subjective standards and documentation used. 4) Packaging and labeling specifications, including methods and processes used. 5) Sterilization requirements and methods. 6) Testing requirements and methods. Delivery Requirements: A. All delivers are FOB Destination to the requesting medical facility: Supplies shall be delivered to the destination warehouse unloading platform, or receiving dock, at the expense of the Contractor. The Government shall not be liable for any delivery, storage, demurrage, accessorial, or other charges involved before the actual delivery (or "constructive placement" as defined in carrier tariffs) of the supplies to the destination.. If motor carrier (including "piggyback") is used, supplies shall be delivered to truck tailgate at the unloading platform of the consignee, except when the supplies delivered meet the requirements of Item 568 of the National Motor Freight Classification for "heavy or bulky freight." When supplies meeting the requirements of the referenced Item 568 are delivered, unloading (including movement to the tailgate) shall be performed by the consignee, with assistance from the truck driver, if requested. If the contractor uses freight forwarded for less than carload shipments, the contractor shall ensure that the carrier will furnish tailgate delivery, when required, if transfer to truck is required to complete delivery to consignee. B. The Contractor shall- (1)(i) Pack and mark the shipment to comply with contract specifications; or (ii) In the absence of specifications, prepare the shipment in conformance with carrier requirements; (2) Prepare and distribute commercial bills of lading; (3) Deliver the shipment in good order and condition to the point of delivery specified in the contract; (4) Be responsible for any loss of and/or damage to the goods occurring before receipt of the shipment by the consignee at the delivery point specified in the contract; (5) Furnish a delivery schedule and designate the mode of delivering carrier; and (6) Pay and bear all charges to the specified point of delivery. C. All deliveries for this contract shall be FOB Destination only. Deliveries shall be made within seventy-two (72) hours from receipt of order by contractor from the ordering facility. Industry Day Questions: The Contractor's shall provide responses to the following questions that will be addressed during the one-on-one meetings: (see attachment)
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/b5ec89ae3c84197a37a2dc4d5884f358)
 

Document(s)

Attachment
 

File Name: VA240C-14-I-0003 VA240C-14-I-0003_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1130180&FileName=VA240C-14-I-0003-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1130180&FileName=VA240C-14-I-0003-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03253786-W 20131219/131217235858-b5ec89ae3c84197a37a2dc4d5884f358 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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