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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 30, 2017 FBO #5698
DOCUMENT

65 -- VISN 2 North Surgical Custom Packs - Attachment

Notice Date

6/28/2017
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;400 Fort Hill Ave.;Canandaigua NY 14424
 

ZIP Code

14424
 

Solicitation Number

VA24217Q0811
 

Response Due

7/7/2017
 

Archive Date

7/22/2017
 

Point of Contact

Sam A DeMuzio
 

E-Mail Address

93-7735<br
 

Small Business Set-Aside

Service-Disabled Veteran-Owned Small Business
 

Description

This is Sources Sought announcement only this is not a Request for Quote. The purpose of this notice is to conduct market research and obtain information from qualified vendors with special interest. No solicitation is being issued at this time. This notice shall not be construed as a commitment by the Government to ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. All responses must be received by Friday, June 7, 2017 by 2:00PM (EST) to the point of contact listed below. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The U.S. Department of Veterans Affairs, Network Contracting Office 2, and the VA Western New York Healthcare System in Canandaigua, NY anticipate a purchase order for the following item: Items: Sterile Surgical Packs The appropriate NAICS Code is 339113. Interested vendors are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the System for Award Management (SAM) database prior to award of a contract. A formal RFQ may be issued upon receipt of information pertaining to this Sources Sought Notice. If you are capable of providing the required item, please send your responses via email NLT Friday, June 7, 2017 by 2:00PM (EST), to Sam DeMuzio, Contracting Officer, at sam.demuzio@va.gov. This acquisition implements a 100% set aside for SDVOSB. The NAICS Code is 339113; size standard is 750 employees. Responses to this notice shall include the following: (a) company name, (b) address, (c) socio-economic status, (d) point of contact, (e) phone, fax, and email, (f) DUNS number, (g) Cage Code,   (h) Tax ID Number, and must  provide a capability statement that addresses the organizations qualifications and ability  to perform as a contractor and provide the commodities described below. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.   Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov.  Requests for information and resultant responses shall be submitted directly to the contracting officer, Sam DeMuzio at sam.demuzio@va.gov. NO TELEPHONE CALLS WILL BE ACCEPTED. 1. PURPOSE. The purpose of this procurement is to purchase Custom Sterile Surgical Packs for VISN2 North Medical Centers located in Buffalo, Syracuse and Albany. 2. PROJECT SCOPE. The Contractor shall provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations, to provide Custom Sterile Surgical Packs for the following medical centers within VISN 2: Albany Stratton VA Medical Center, 113 Holland Ave, Albany, NY 12208 VA Western New York Healthcare System, 3495 Bailey Ave, Buffalo, NY 14215 Syracuse VA Medical Center, 800 Irving Ave, Syracuse, NY 13210 3. CONTRACTOR PERFORMANCE 3.1. 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. 3.1.1. 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. 3.1.2. Component bio-burden, sterility tests, and residual tests are to be performed by contract laboratories at contractor's expense. 3.1.3. Prior to sterilization, products shall be assembled in controlled rooms, which are open only to authorized personnel with proper attire. 3.1.4. 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. The Contractor shall have a sanitation program that monitors levels of microbial contamination regularly. 3.1.5. 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. 3.1.6. The Contractor assumes the responsibility and liability for the sterility and quality of the product when properly used and handled by the Government. 3.1.7. Re-sterilization of any product is prohibited. 3.1.8. 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 IS09001:2000 (International Organization for Standardization) certified and undergo routine FDA inspections. 3.1.9. All component products shall be inspected upon arrival at the Contractor's plant and checked for damage and unacceptable expiration dates. 3.1.10. Contractor is responsible to have continual maintenance performed on all sterilizing equipment. 3.1.11. 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. 3.2. 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. 3.2.1. 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. 3.2.2. All component items required for the tray/pack are to be provided by the Contractor. 3.2.3. All packs are to use hard 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. 3.2.4. 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 (NF PR) for flammability in Part 1610 of the Code of Federal Regulations. 3.2.4.1. Materials shall be of a soft, memory-free type that precludes shifting of drapes. 3.2.4.2. Material shall be non-abrasive and free of toxic ingredients, non-fast dyes and noxious odors. 3.2.4.3. Materials shall be non-glare and of a color that minimizes distortion from reflected light. 3.2.4.4. Gowns shall fit and allow freedom of movement. Gowns shall have stockinet cuffs, raglan sleeves and welded or stitched seams. 3.2.4.5. Gowns and drapes shall maintain an environment appropriate to body temperatures. 3.2.5. When cloth towels are specified, they are to be absorbent, disposable or towels made of 100% cotton, pre-washed with x-ray detectable loop. 3.2.6. 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. 3.2.7. 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. 3.3. 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 Healthcare Representative 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. 3.4. 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 the 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. 3.4.1. 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. 3.4.2. 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 the facility for the fiscal year, annually or per order, during the life of the contract. 3.4.3. 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. 3.4.4. 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. 4.0 PRODUCTION AND SUPPLY. The Government requires the Contractor to undertake production of such quantities of the product as are necessary to reasonably assure the Government of an uninterrupted supply of the product based upon the estimated quantities provided. 5.0 DELIVERY PERIOD AND QUANTITIES 5.1 Contractor will have 30 days from contract award date to deliver the estimated monthly usage quantities as specified below, thereafter; supplies will need to be delivered within 3 business days from the time order is placed. This time frame does not include emergencies. Please see the chart referenced below: Albany Description EA/PK Est. Annual Usage Major Pack CS/3 480 Minor Pack CS/4 1200 Cysto Pack CS/10 360 Total Joint Pack CS/4 192 AAA pack   CS/2 6 Arthroscopy Pack CS/4 144 Syracuse OR SET UP PACK CS/5 300 CASES Cysto Pack CS/5 240 CASES KNEE ARTHRO PACK CS/3 60 CASES HIP PACK CS/5 120 CASES EYE PLASTIC PACK CS/3 12 CASE NEURO PACK CS/2 156 CASES Cardiac cath Manifold CS/5 70 CASES ANGIO PACK CS/5 192 CASES Buffalo Major Basin CS/5 1893 packs Vascular Pack CS/4 45 packs CABG Pack CS/1 72 packs LAP III CS/8 331 packs LAP II CS/8 85 packs Left Heart CS/4 742 packs Podiatry CS/4 288 packs Vascular Pack CS/4 399 packs Hip CS/2 83 packs Knee CS/2 118 packs 6.0 QUALITY ASSURANCE. 6.1. The Custom Sterile manufacturing facilities must be registered and in good standing with The Food and Drug Administration and IS09001:2000 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. 6.2. 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. 6.3. The Custom Sterile Surgical Pack program must provide certain measures in the manufacturing of the kits. 6.3.1. 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. 6.3.2. Production process specifications, including the appropriate equipment specification, production methods, production procedures, compatibility of the design with current systems and equipment. 6.3.3. 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. 6.3.4. Packaging and labeling specifications, including methods and processes used. 5.3.5. Sterilization requirements and methods. 6.3.5. Sterilization requirements and methods. 6.3.6. Testing requirements and methods. 6.4. Warranty/Maintenance: Proper instructions for disposal or trade out, as well as shipment back to Prime Vendor (if applicable). All packs will be required to have a shelf life of a year; at 6 months (if the expiration date is applicable) if packs haven t been used, would like option trade clause at no cost within 30 days of expiration, the VA would then receive another custom pack with a year shelf life or new expiration date. Custom packs must be able to be rotated to provide an up to the date service to the veteran. Also assist in the reduction of cost or avoid disposal of custom packs. (BASED UPON INDUSTRIAL STANDARDS) 6.5. Special Material Requirements: 6.5.1 Ensure that the supplies in the custom pack meet the American Trade Act (***in that a certain percentage of those supplies used are not made by China or other non-compliant suppliers) 6.5.2 The customer has the right to request changes to the contents of the custom pack. The customer understands all previously made packs must be used before the new custom pack is manufactured and made available for use. 6.5.3 All custom packs will be sterilized using acceptable techniques that comply with Veterans Affairs policies, prior to shipment to a VISN 2 facility. 6.5.4 All custom packs should be wrapped in a protective, clear wrapping plastic to ensure the pack is protected during shipment. 6.5.5 Each custom pack will have a contents list displaying all the supplies that are listed in that pack along with the quantities. It should be placed in the pack so a user can see it. 6.5.6 Any Other Requirements unique to the solicitation. 6.5.7 Due to unforeseen surgical procedures, par levels may change from time to time. It is highly recommended that the customer and vendor review these levels on a quarterly basis to ensure stock levels are maintained adequately. 6.5.8 If a vendor experiences difficulty at any point with manufacturing a custom packs, they will advise the customer in advance to ensure customer can make other arrangements. Examples could be back orders of supplies, or other unforeseen circumstances.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/CaVAMC532/CaVAMC532/VA24217Q0811/listing.html)
 

Document(s)

Attachment
 

File Name: VA242-17-Q-0811 VA242-17-Q-0811.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3619842&FileName=VA242-17-Q-0811-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3619842&FileName=VA242-17-Q-0811-000.docx

 

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

Record

SN04561516-W 20170630/170628235253-20045e987fea92fd6467a6b894d9eda8 (fbodaily.com)
 

Source

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

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