SUPPLEMENT B - SCOPE OF WORK - Veterans Affairs



FedBizOppsCombined Synopsis/Solicitation Notice*******CLASSIFICATION CODESUBJECTCONTRACTING OFFICE'S ZIP-CODESOLICITATION NUMBERRESPONSE DATE (MM-DD-YYYY)ARCHIVE DAYS AFTER THE RESPONSE DATERECOVERY ACT FUNDSSET-ASIDENAICS CODECONTRACTING OFFICE ADDRESSPOINT OF CONTACT(POC Information Automatically Filled from User Profile Unless Entered)DESCRIPTION*See AttachmentAGENCY'S URLURL DESCRIPTIONAGENCY CONTACT'S EMAIL ADDRESSEMAIL DESCRIPTION ADDRESSPOSTAL CODECOUNTRYADDITIONAL INFORMATIONGENERAL INFORMATIONPLACE OF PERFORMANCE* = Required FieldFedBizOpps Combined Synopsis/Solicitation NoticeRev. March 201065VA258-16-Q-0091-Custom Surgical Paks (Multi-Station)85014VA258-16-Q-009106-01-201660N339112Department of Veterans AffairsVISN/18PHX777 E. Missouri, Suite 300Phoenix AZ 85014THOMAS W MCKENDRYCONTRACT SPECIALIST602-795-4372SEE Scope of WorkTHOMAS.MCKENDRY@THOMAS.MCKENDRY@This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the FAR (Federal Acquisition Regulation) Part 13 and Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only Combined Synopsis/Solicitation requested and a written solicitation will not be issued. This announcement constitutes the only Combined Synopsis/Solicitation; quotations are being requested and no further solicitation will be made.The Combined Synopsis/Solicitation Number is: VA258-16-Q-0091 This Combined Synopsis/Solicitation is issued as an Request for Quotation (RFQ). The award will be FIRM FIXED PRICE, BLANKET PURCHASE AGREEMENT (BPA), not to exceed 90 Days. The Ceiling for this BPA is not to exceed, $149,999.00. The Government intends to award multiple BPA’s. This requirement is set aside 100% for Service Disabled Veteran Owned Small Businesses only.Quotes are due via email to the Contracting Specialist, Thomas W. McKendry at thomas.mckendry@ with VA258-16-Q-0091 Custom Packs in the SUBJECT line by 1500 MST 01 June 2016. NO EXCEPTIONS. Duns Number and Cage code are required with quote submission.Question Submission: Interested offerors may submit any questions concerning the solicitation prior to __1500 MST 25 May 2016__. Questions must be submitted by email to Thomas W. McKendry at thomas.mckendry@ with VA258-16-Q-0091 Custom Packs in the subject line. Questions not received within the time or format specified will not be considered. No telephonic requests will be entertained. All responses to questions will be emailed to all interested parties. All questions must be addressed to the Contracting Specialist only. Any other official may disqualify the offeror from submission of a quote. Offerors are encouraged to check the Federal Business Opportunity (FEDBIZOPS) website at for any amendments to this combined synopsis/solicitation. This acquisition is 100% set aside for Service Disabled Veteran Owned Small Business under NAICS: 339112 – 1000 Employees.For description of supplies needed, see attached Scope of Work.Quotes will be submitted in the following format:See attached P01_Custom_Packs.pdf. All pricing must be entered onto fields of the pdf and submitted with the response to the RFQ. The Combined Synopsis/Solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-88. Effective May 16, 2016.The provisions and clauses, which are incorporated herein by reference or full text, apply to this acquisition:FAR 52.212-2 Evaluation- Commercial Items (JAN 1999). Specifically (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:The Lowest Priced, Technically Acceptable Offeror will be afforded the opportunity for a Blanket Purchase Agreement. FAR 52.204-99 System for Award Management Registration(Deviation)FAR 52.212-3 Offeror Representations and Certifications-Commercial Items (APR 2016). Offerors shall include a completed copy of the provision with its offer.FAR 52.212-4 Contract Terms and Conditions (MAY 2015).FAR 52. 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (MAR 2016), paragraph (a) and the following clauses in paragraph (b) are not limited to 52.222-26, 52.222-35; 52.222-36, 52.222-37, the full text of the referenced FAR clauses may be accessed electronically at https: //far/.FAR 52.204-7 System for Award Management Registration (JUL 2013).VAAR 852.211-73 Brand Name or Equal.852.219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.New equipment only; no remanufactured or “gray market” or refurbished items. All items must be covered by the manufacturer’s warranty.Quote SHALL be good for 30 calendar days after close of Combined Synopsis/Solicitation. Shipping must be free on board (FOB) destination CONUS (Continental U.S.) which means that the seller must deliver the goods on its conveyance at the destination specified by the buyer, and the seller is responsible for the cost of shipping and risk of loss prior to actual delivery at the specified destination. The delivery location is: Southern Arizona VA Health Care System3601 S. 6th AvenueTucson, AZ 85748SUPPLEMENT B - SCOPE OF WORKSee attached document: P01_Custom_Packs.STATEMENT OF WORKPURPOSEThe Southern Arizona VA Health Care System Hospital in Tucson, AZ requires custom surgical packs in order to provide surgical services to Veteran patients. Custom surgical packs are comprised of various medical supplies for specific areas, e.g., Catheterization Lab, Operating Rooms, etc., within each facility.The Government intends to award up to two bridge Blanket Purchase Agreement (BPA) arising from this solicitation is intended to provide surgical packs to the Tucson Facility until such time as a regional contract can be awarded by the Western States Network Consortium (WSNC) Contract staff. The BPA is anticipated to be in effect for a period not to exceed 90 Days. SCOPEThe Vendor shall provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations, to provide Custom Sterile Surgical Packs/Custom Procedure Tray (CPT) and creation of new packs, as deemed necessary for the participating Government Healthcare facility. The nature of this Blanket Purchase Agreement typically requires numerous changes to, as well as discontinuance and replacement of, existing packs. The VISN 18 Contracting Officer reserves the right to make such changes, additions, and deletions to existing packs. VENDOR SPECIFIC TASKSThe Vendor shall provide for each custom procedure trays (CPT) a lot number to allow for clear tracking of all packs and products. The Vendor shall insure that the manufacturer and lot number of each component item is traceable. The Vendor 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. Following Blanket Purchase Agreement award, the Vendor will coordinate final components of each pack and obtain approval from the Contracting Officer before building/delivery begins.STERILIZATION REQUIREMENTSThe sterilization process (whether on site or off-site/outsourced) used by the Vendor, shall be validated on an annual basis by the Association for Advancement of Medical Instrumentation (AAMI. The validation must be sent to the Contracting Officer upon annual inspection.Independent contract laboratories shall perform component bioburden tests, sterility tests, and residual tests.Prior to sterilization, products shall be assembled in controlled rooms, which are open only to authorized personnel with proper attire.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 Vendor shall have a sanitation program that monitors levels of microbial contamination regularly. All aspects of the assembly, packaging and sterilization shall adhere to FDA quality control standards. The Vendor shall be registered with the FDA.The Vendor shall be both responsible and liable for the sterility and quality of the product when properly used and handled by the Government.Re-sterilization of any product is prohibited.The Vendor shall 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 certified and undergo routine FDA inspections. Upon arrival at the Vendor’s plant, all component products shall be inspected and checked for damage and unacceptable expiration dates.The Vendor shall guarantee the serviceability of all sterilizing equipment by either performing or insuring all required scheduled and unscheduled maintenance is performed. 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 PONENT PARTSListings are contained in the Attachment . The components are listed as Brand Name or equal for most items. The provision of the Brand Name or Equal clause contained in VAAR 852.211-73 applies. When exercising the options of supplying an item considered to be “equal”, the item shall be of equal size, dimensions, composition and quality to the brand named item specified.If the Vendor proposes an “equal” item, the Vendor shall specify which listed CPT component is being substituted and also provide complete specifications on the “equal” product If no substitution of an equal product is specified or offered, the offeror will notify the Agency, and then may provide the pack as specified.The Vendor shall provide all components required for each CPT.All packs shall be made of hard plastic base trays and components parts to reduce ETO (Ethylene Oxide) residue and eliminate possible particulate contamination from Styrofoam. ETO tape/indicator shall be affixed to the outer wrap and tray where applicable. All packs shall be double wrapped with an additional plastic over wrap (gas pouch). The over wrap shall be considered a dust cover only.Quantitative data shall be provided to demonstrate that the materials for surgical gowns and drapes provide an effective barrier to microbes. The materials shall 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 shall 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.Materials shall be of a soft, memory-free type that precludes shifting of drapes.Material shall be non-abrasive and free of toxic ingredients, non-fast dyes and noxious odors.Materials shall be non-glare and of a color that minimizes distortion from reflected light.Gowns shall fit and allow freedom of movement. Gowns shall have stockinet cuffs, raglan sleeves and welded or stitched seams.Gowns and drapes shall maintain an environment appropriate to body temperatures.When specified within a CPT, cloth towels shall be absorbent and either disposable or towels made of 100% cotton, pre-washed with x-ray detectable loop. All CPT components and wrappings shall be Latex Free unless specified otherwise by the using facility. All CPTs shall be labeled as “Totally Latex Free” on the outside covering.Unavailability of Component Parts: Should a component part become unavailable which will temporarily or permanently delay the production of the pack(s), the Vendor shall immediately notify the Contracting Officer’s Representative (COR) listed notification group (that will be provided) 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.Recalls: The Vendor shall have a documentation system for component product accountability and lot number recordings for product recalls. The Contracting Officer shall be notified immediately by telephone (with written notice to follow within five (5) calendar days) if a one/several CPT are 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 Vendor without written authorization of the Contracting Officer, with notification and approval of the listed notification group. D. CHANGES TO COMPOSITION/COMPONENTS OF CPT(S)Any participating Healthcare Facility may change individual component parts of the tray/pack after thirty (30) days of usage. Pricing and recommended requested changes will be forwarded to the Vendor by the facility COR. The Vendor shall be requested to consider all component part changes and provide a cost estimate of each item to be changed. The cost proposal will include costs plus an estimate for credit for deleted items. In accordance with FAR clause 52.212-4(d), changes may be made only by written agreement of the parties. Only the Contracting Officer has the authority to make changes to the Blanket Purchase Agreement. Changes will be made by Blanket Purchase Agreement modification/supplemental agreement.A Pack Change Worksheet shall be utilized for all pack changes. The change form includes all of the components, quantity and manufacturer detail for the affected pack.The sales representative (or equivalent) shall supply the COR with the completed change form. With the agreement of the two parties, each shall sign the change form.The signed change form shall be forwarded to the Contracting Officer for approval. Once approved by the Contracting Officer, the Contracting Officer shall issue a Blanket Purchase Agreement modification/supplemental agreement; the change shall be submitted to the Vendor for the next production run of that pack.The arrangement of the component parts in the tray/pack shall be coordinated by both the designees and COR. This coordination shall be prior to production by the Vendor. E. PACKAGINGUnless 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) shall be constructed to insure acceptance and safe delivery by common carriers, at the lowest rate, to the point of delivery for each facility. Items shall be packaged adequately to prevent deterioration and damage during shipping, handling and storage. All packs shall be labeled on the outside as Totally Latex Free. 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.All outer packages must contain the complete Blanket Purchase Agreement number and delivery order number in addition to the shipping address. The Blanket Purchase Agreement number shall be provided upon notice of Blanket Purchase Agreement 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 Blanket Purchase Agreement.A packing list/slip shall be enclosed with each shipment indicating the Blanket Purchase Agreement number, delivery order number, items and quantity ordered and items and quantity shipped.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 Vendor at the Vendor’s expense. Full credit or replacement shall be made to the Government.PRODUCTION AND SUPPLYThe Government requires the Vendor 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 an anticipated monthly usage. The Government may not obligate funds for product in inventory or production whenever the Blanket Purchase Agreement is terminated. The Vendor shall complete component pack changes within thirty (30) days, no longer than forty-five (45) days after written notification by the Contracting Officer. Due to the possible need for changes, the Government shall be obligated to only a thirty (30) day supply of packs manufactured at the time of the change acceptance and not exceeding the current fiscal obligation time period. In the event the Government terminates the Blanket Purchase Agreement, the Government will not be held responsible to procure the additional inventory. In the event of component changes only in any pack, the Government has sole discretion to purchase up to a maximum thirty (30) day usage of the current pack composition before the new pack composition is shipped. The Quality Assurance Department shall verify changes and ensure the product meets the Government specification.When additions or deletions occur, the Vendor shall provide the Contracting Officer with the costs of each individual component added or deleted at the time of the change or before written authorization by the Contracting Officer.As a fixed-price Blanket Purchase Agreement, it is reasonable to expect usage and/or requirements may change during the Blanket Purchase Agreement period. The Government reserves the right to negotiate with the Vendor to add and/or delete item(s) to pack components.QUALITY ASSURANCEThe Custom Sterile manufacturing facilities shall 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. “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.The Custom Sterile Surgical Pack program must provide certain measures in the manufacturing of the kits.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.Production process specifications, including the appropriate equipment specification, production methods, production procedures, compatibility of the design with current systems and equipment.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.Packaging and labeling specifications, including methods and processes used.Sterilization requirements and methods.Testing requirements and methods.VENDOR PERSONNELVendor’s Program Manager. The Vendor shall provide a Contract Manager who shall be responsible for the performance of work. The name of this person shall be designated in writing to the Contracting Officer. The Vendor’s program manager shall have full authority to act for the Vendor on all matters relating to daily operations of this contract.Vendor Employees. The Vendor shall not employ persons for work on this contract if such employee is identified to the Vendor as a potential threat to the health, safety, security, general wellbeing or operational mission of the installation and its population.The Vendor shall perform services in accordance with the ethical, professional and technical standards of the healthcare industry as consistent with VA and DoD Policy, Regulations and Procedures.INSPECTIONSThe Government may, at its option and expense, request an unrelated third party to inspect the packs provided by the Vendor. The Vendor shall repair, at the Vendor’s cost, any faults or omissions discovered by the inspection of the third party within fifteen (15) days when notified by the Contracting Officer. All routine inspection/acceptance will be performed at the delivery destination and in accordance with FAR clause 52.246-2 Inspection of Supplies - Fixed-Price.HOURS OF OPERATIONDelivery days are Monday through Friday, National Holidays excluded. Any delivery service performed during other than normal work hours must be approved in advance by the COR in writing. Each facility will specify its delivery hours and complete address.Holidays. The Vendor is not required to provide delivery services on the following National Holidays:Holiday Date(s) Month Independence Day4July Labor Day First MondaySeptember Columbus Day Second Monday October When a holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.ORDERING, INVOICE AND PAYMENTDeliveries will be made upon receipt of an individual delivery order (written) issued by the participating facilities. Each delivery order will state the quantity of packs required, delivery date, and delivery and billing address. A delivery order number will be assigned to each request for delivery against this Blanket Purchase Agreement.Vendor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities will place orders:Name: Address: Phone No.: Fax No.: Contact Name: Email: Name: Address: Phone No.: Fax No.: Contact Name: Email: The Vendor shall submit properly completed individual itemized invoices to the addresses designated by the facilities to receive invoices, in accordance with FAR clause 52.212-4 Contract Terms and Conditions – Commercial Items. In addition to the requirements of FAR 52.212-4(g), the invoice shall also include the facility’s name and address where the product is delivered and the delivery order number. The invoice address payment office shall be provided to the Vendor at time of delivery order placement by the order-placing facility. Additional information can be found in the Blanket Purchase Agreement administration section of the Blanket Purchase Agreement.No advance payments shall be authorized. Payment shall be made on a monthly basis for product provided during the billing month in arrears in accordance with FAR 52.212-4, para. (i) upon submission of a properly prepared invoice for prices stipulated in this Blanket Purchase Agreement for products delivered and accepted in accordance with the terms and conditions of the Blanket Purchase Agreement, less any deductions stipulated in this Blanket Purchase Agreement.Payment of invoices may be delayed if the appropriate invoices as specified in the Blanket Purchase Agreement are not completed and submitted as required.DELIVERY REQUIREMENTSAll deliveries for this Blanket Purchase Agreement shall be FOB Destination only, in accordance with clause 52.247-34. In case of an emergency, deliveries shall be made within twenty-four (24) to forty-eight (48) hours depending on the Government’s need using the Government purchase card. For emergencies, shipping costs will be based on common carrier rates such as but not limited to, United Parcel Service, United States Postal Service and FedEx published rates, by weight, from Vendors zip code to delivery location’s zip code. All other deliveries must be shipped within twenty-four (24) to forty-eight (48) hours and delivered within five (5) to seven (7) business days from receipt of order.The Government shall be held harmless against any or all loss, cost, damage, claim expense or liability whatsoever, because of accident or injury to persons or property of others occurring in the performance of this Blanket Purchase Agreement.The Vendor shall be responsible for all damage to property, which may be done by him, or any employee engaged in the performance of this Blanket Purchase Agreement.FURNISHED ITEMS AND SERVICESThe Government shall not provide the facilities, equipment, materials, or any products under this Blanket Purchase Agreement.The Vendor shall furnish and provide everything required to perform this Blanket Purchase Agreement in accordance with all of its terms.REQUIRED REGISTRATIONSCentral Contractor Registration (CCR)/System for Award Management (SAM): Pursuant to FAR Clause 52.212-4, para (t), Central Contractor Registration (CCR), after initial registration, the Vendor is required to update registration data as changes occur and must re-register annually to ensure all data remains current. Noncompliance with this requirement will preclude the exercising of any option periods that may be included herein and will be cause for termination of the Blanket Purchase Agreement at such time noncompliance is discovered. Refer to cited Clause for more detailsCALL LIMIT:The Single call limit for Primary and Alternate Shipping Officers is $100,000.00 per order. Calls may be placed daily, weekly, monthly depending on need.BPA CEILING:The ceiling for this BPA is not to exceed $150,000.00.DELIVERY INSTRUCTIONSSupplies will be ordered by individual Calls by each station. The warranted Contracting Officer or the delegated Ordering Officers listed below are the only individuals that are authorized to place Calls under this Blanket Purchase Agreement. Any Call received that is placed by anyone other than the individuals listed shall not be processed and the Contracting Officer shall be notified immediately. Any orders placed under $3,500.00 will be paid via credit card by each individual station. For orders over $3,500.00 an “A” numbered delivery order will be provided. All unauthorized deliveries, regardless of amount, will be processed through the ratification process.Authorized IndividualsSouthern Arizona VA Health Care System3601 S. 6th AvenueTucson, AZ 85748$3,500.00 and under: Any VA Government Credit Card HolderOver $3,500.00: Ordering Officer Primary: 1. Charles French - 520-629 – 4790 - Charles.French@ Ordering Officer Alternate: 2. Joseph Natoli – 520-792-1450 Ext 6244 - Joseph.Natoli@ ................
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