Breast Implant Supplies

Indian Health Service (IHS), Phoenix Area Office (PAO), Division of Acquisition Management (DAM)Place of Performance: Phoenix Indian Medical Center (PIMC), Phoenix, AZSolicitation No: 18-247-SOL-00012-2 Date Issued: March 26, 2018Due Date: Thursday, April 26, 2018, 4:00 PM MSTIssued by: Donovan Conley, Contract SpecialistEmail: donovan.conley@ihs.gov Telephone: 602-364-5174The Government intends to award one and three multiply award Firm-Fixed Price Indefinite Delivery Indefinite Quantity (IDIQ) contracts that will cover the period of performance for 12-months of breast implant supplies for a one base (1) year base year and the four (4) one (1) year options.Breast Implant SuppliesThe Indian Health Service (IHS), Phoenix Area Office (PAO), Division of Acquisition Management (DAM) intends to procure breast implant supplies for patients post breast mastectomies either malignant or benign, or asymmetries for post reconstructive

surgery. Supplies are to be delivered to the Phoenix Indian Medical Center, Integrated Surgical Services (ISS)/Operating Room (OR) Department in accordance with the Statement of Work (SOW) and terms and conditions of the contract.Place of Performance:Phoenix Indian Medical Center4212 North 16th StreetISS/OR DepartmentPhoenix, AZ 85016NOTICES:1. This is a Combined Synopsis/Solicitation.2. ISSUED AS FULL AND OPEN COMPETITIONThe NAICS Code/Size Standard: 339113 / 750 EmployeesSECTION I - COMBINED SYNOPSIS & SOLICITAION NOTICEThis is a combined synopsis/solicitation for commercial supplies prepared in accordance with the format in Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR Part 13, Acquisition Procedures; and as supplemented with additional information included in this notice. This announcement constitutes the only solicitations; proposals are being requested and a written solicitation will not be issued. The Solicitation Number is 18-247-SOL-00012-2. This solicitation document incorporates all mandatory commercial item provisions and clauses that are in effect through Federal Acquisition Circular (FAC) 2005-96 dated November 8, 2017.SECTION II - INSTRUCTIONS TO OFFERORS: ADDENDAFAR 52.212-1 INSTRUCTIONS TO OFFERORS - COMMERCIAL ITEMThis section specifies the format and content that offerors shall use in response to this Request for Proposal (RFP). Offerors shall submit a response that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided shall be precise, factual and complete. Legibility, clarity, completeness and responsiveness are important. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified below. Any proposal which does not meet the requirements of the solicitation may be determined to be substantially incomplete and may result in rejection of the offeror's entire proposal.The proposal shall be submitted in three separate sections:Volume I: Technical ProposalVolume II: Past Performance ProposalVolume III: Price ProposalA complete Volume I -Technical Proposal, Volume II - Past Performance Proposal, and Volume III - Price Proposal shall be submitted no later than the offer due date of April 26, 2018 at 4:00 PM MST. If any one proposal section is received past the stated closing date, the entire proposal will be considered late. No further consideration will be given to any offeror who submits any of the sections late in accordance with FAR 15.208(b).Volume I - Technical Proposal:A. Requirements: Offerors shall submit proposal specification information as stated in the Statement of Work under Paragraph Requirements. This shall include product specification, statement of understanding substitution or alterations, details on providing appointed representative, and provide all necessary documentation of FDA approved products or non-FDA products, and supplier manufacturer details.B. Ordering Procedures: Offerors shall submit a proposal of their order procedures as stated in the Statement of Work under Paragraph Ordering Procedures.C. Warranty: Offerors shall provide a proposal on their product's warranties.D. Delivery Days: Offerors shall provide the number of days of delivery after the receipt of order (ARO).Page limitation for Technical: The total number of pages shall not exceed twenty (20) pages, excluding the cover letter, title page and table of contents. If Technical contains more than the mandated page count then only the first twenty (20) pages will be evaluated.Volume II - Past Performance:Offerors shall provide recent and relevant contracts for the same or similar items for one or up to three (3) references within the last three (5) years. Contracts cited must be current, or have ended not more than three (5) years prior to the closing date of this solicitation. If the contract performance ended more than three (5) years prior to the closing date of the solicitation it will be determined not relevant.The data for each reference shall contain at a minimum the following:Company Name:___________________________________Address:_________________________________________Contact Name:_____________________________________Contact Telephone No:_______________________________Contact Fax No:_____________________________________E-mail Address:_____________________________________Contract Number (if applicable):________________________Supplies Provided:___________________________________Service Period:______________________________________Information Comments:_______________________________If the offeror does not possesses relevant past performance, the offeror shall submit a statement affirming that it possesses no relevant Past Performance.The Government may contact the POCs listed on the Past Performance Information Sheets. POCs must be either Government personnel (civil service or military) or employees of private sector clients with whom it has provided services. Information provided by or for POCs who work directly for the offeror or a teaming partner will be determined not relevant.The Government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided.Page limitation for Past Performance: The total number of pages shall not exceed five (5) pages, excluding a cover letter and title page. If Past Performance contains more than the mandated page count then only the first five (5) pages will be evaluated.Volume III - Price:The offeror shall include the following:• Completed "Pricing Schedule" that accompanies solicitation as an attachment.• Adequate price competition is expected for this acquisition. Offeror shall submit individual line item pricing for each item below. Offerors shall submit firm-fixed pricing for the requirement. Include commercial price lists; any applicable discounts, GSA/VA Contracts and F.O.B Destination to the Government. Offerors shall include estimated timeframe, after the receipt of order, for delivery of supplies.• Prices shall be good for 60 days.FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEM (JAN 2017)Registration in SAMVendors not registered in the System for Award Management (SAM) database at the time the requirement is to be awarded will not be considered. Vendors may register with SAM by going to the website - www.sam.gov. FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2017) is included by reference (full text is available electronically at http://www.acquisition.gov/far. A completed copy of this provision must be included with response. Offeror shall complete only paragraph (l) of this provision if the offeror has completed the annual representations and certifications electronically at https://www.sam.gov. If an offeror has not completed the annual representations and certifications electronically at the SAM website, the offeror shall complete only paragraphs (b) through (l) of this provision.Only written requests for additional information will be accepted. Notification of any changes shall be made only on theFedBizOpp website.Acknowledgement of solicitation number 18-247-SOL-00012-2 as well as all amendments (if applicable) must be made. Acknowledgement may be in the form of an email with the solicitation, signature on any amendments and the pricing schedule.QuestionsAny questions must be addressed to Donovan.Conley@ihs.gov by email only no later than January 29, 2018 at 12:00 PM MST.No phone calls will be accepted.ResponsesAll responses should be submitted electronically to Donovan.Conley@ihs.gov by 04:00 pm MST January 29, 2018 of the solicitation. The Volume I - Technical, Volume II - Past Performance, and Volume III - Price shall be submitted via e-mail only. Files shall be in Microsoft Word, Microsoft Excel or Adobe PDF only.Subject line should read: Solicitation #18-247-SOL-00012-2Emails shall be no larger than 10 MBAll proposals shall include the following information on its cover page:• Complete company name and address• Company POC including title, email address and phone number• Cage Code• DUNS Number• Place of ManufacturePeriod for Acceptance of OffersThe offeror agrees to hold the prices in its offer from for 60 calendar days from the date specified for receipts of offers within which offer may be accepted. .SECTION III - PRICE SCHEDULEThe Contractor shall furnish all required breast implant supplies as listed in the Pricing Schedule in accordance with the Statement of Work (SOW) and all other terms and conditions specified herein.a. Period of the Contract: One (1) base year and four (4) one (1) year options.b. The minimum amount the Government will acquire is $2,000.00 and the maximum value the Government will acquire is $150,000.00 under this contract.DELIVERY LOCATION:Phoenix Indian Medical Center4212 North 16th Street, Warehouse, Bldg-9Phoenix, AZ 85016.Phone: 602-263-1523Responsibility and Inspection: Unless otherwise specified in the contract or purchase order, the supplier is responsible for the performance of all inspection requirements and Quality Control (QC).PRICING SCHEDULE: See attachment 18-247-SOL-00012-2Total Award amount shall not exceed $150,000.00 for the base and option years.SECTION IV - STATEMENT OF WORK (SOW)Project Title: Breast Implant Supplies1. Requirements:Phoenix Indian Medical Center has a requirement for reconstruction breast implants and expanders. The contractor shall provide Saline and Gel breast implants and that are filled with a silicone gel or saline that holds together uniformly and retains a natural shape and texture that will resemble breast tissue. The implants must have a set-fill volume for predictable results. The breast implants are pre-filled to an appropriate volume that is required by the surgeon. Offerors shall provide a full complement of volume amounts ranging from 80cc to 800cc. Saline or Gel shall not be added or removed from the implant. Tissue expanders, used in breast reconstruction shall be designed to allow for differential expansion of the breast pocket (greater expansion in the lower portion of the breast). The expander should have an integral "injection port" that allows for simplified and more convenient expansion. Offerors shall provide at a minimum a 30mm port. However, a larger port entry point is optimal due to the potential patient risk should an expander puncture occur.The technical requirements shall include the styles described within the Price Schedule (See Section III, Price Schedule). Offerors shall provide their gel implant, saline implant and expander listing specifications for verification of the models, styles, profiles, catalog number, volume, width and projections along with their proposals.The Contractor shall not provide substitutions or alterations to the product to be ordered without the express written consent from the Contracting Office and the approval from PIMC. The Contractor shall make no adjustments, changes, deletions or additions to the list of products to be provided without a written contract modification from the Contracting Officer. Request for modification must be submitted in writing to the Contract Specialist as specified in the Instructions to Offerors.The Contractor shall provide product support to PIMC. The Contractor shall appoint a representative for the routine interactions with the PIMC. The Contractor shall provide a name, email address, and phone number for this individual. If the Contractor changes its appointed representative, it must notify PIMC in writing and provide the new representatives contact information. This individual shall be well-versed in the items provided by the Contractor under the contract and be able to address any technical issues/questions.The supplies shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver of medical products for use in the United States of America. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America. Offerors must notify the Contract Specialist identified in this requirement in the event there are any non-compliance issues with the product being supplied.Contractor shall be the original supply manufacturer, authorized dealer, authorized distributor or authorized reseller for the proposed supplies. Warranty and service are provided and maintained by the original supply manufacturer.2. Ordering Procedures:The Government will utilize a provisional ordering program. The Contractor shall be responsible on providing a worksheet for Ordering Officials to place implants and expanders orders. The Ordering Officials will provide the Contractor an order no earlier than 14 days before surgery. Orders shall be delivered FOB Destination. All unused implants and expanders must be returned within 30 days after surgery and the Contractor will provide prepaid return labels and phone number with their designated transportation carrier. No additional charges or shipping may be levied against the Government in order to meet this requirement and the cost of shipping/delivery will be included in the contract. The Contractor shall provide email notices to the COR and Ordering Officials to return unused implants and expanders. On the last day of month the Contractor shall provide PIMC an invoice for the ordered implants and expanders.The Government will issue Task Order(s) as the need arises either in a lump sum for the year or for individual emergencies. RFQ's may be issued to all awardees and award given to the best offerer or as time the requirement necessitates, the requirement may just be awarded as the Contracting Officer deems necessary. If an RFQ is issued, the evaluation criteria is lowest price.3. Estimated 1 Year Quantities by Category:Line Item Unit QuantityA. Expander With Tabs Each 3B. Expander Without Tabs Each 2C. Gel Sizers Each 2D. Saline Implants Each 3E. Gel Implants, Shaped Cohesive Each 8F. Gel Implants, Smooth Round Each 8SECTION V - BASIS FOR AWDARDFAR 52.212-2 EVALUATION - COMMERCIAL ITEMS (OCT 2014)(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:TechnicalPast PerformancePriceTechnical and past performance, when combined, are greater in importance than price.(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.ADDENDUM to FAR 52.212-2 EVALUATION - COMMERCIAL ITEMSBASIS OF AWARD: Award will be made on a firm fixed price basis and will be based on a scoring system recognizing all the factors as shown above. The Government intends to make an award based on initial offers, without discussions. As such, Contractors are encouraged to submit their best proposal as their initial offer. While the Government intends to award based on initial offers, the Government reserves the right to open discussions with all Contractors within the competitive range should the Contracting Officer make a determination that discussion would be in the best interest of the Government.The contract will be awarded to the offeror that presents the best value to the government. Technical and past performance when combined are greater in importance than price.The evaluation process shall proceed as follows:Initially, all technical proposals submitted by offerors will be evaluated. The past performance information provided will be validated by contacting the offeror's submitted information. The price proposal will be evaluated to determine a fair and reasonable price. An award shall be made to the offeror who's proposal represents the best overall value to the Government.The following factors shall be used to evaluate offers:TECHNICAL EVALUATION FACTORS:A. Requirements: Proposal specification information necessary for providing the required supplies as stated in the Statement of Work under Paragraph Requirements.B. Ordering Procedures: Proposal information necessary to provide the ordering procedures as stated in the Statement of Work under Paragraph Ordering Procedures.C. Warranty: Warranty information on all products.D. Delivery Days: Number of days.PAST PERFORMANCE EVLAUATION FACTORS:The Government will first evaluate the offeror's Past Performance references to determine whether the company has provided relevant Past Performance. A determination of relevant or not relevant will be made for each reference. A relevancy determination may be made based solely on the information provided on the past performance.Past performance information may be obtained from any other sources available to the Government, such as Past Performance Information Retrieval System (PPIRS) and interviews with Contracting Officer's Representatives/Technical Liaisons.The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure names and phone numbers of points of contact are verified and accurate. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror will not be evaluated favorably or unfavorably on past performance (FAR 15.305(a)(2)(iv)). The offeror will receive a neutral rating.Past Performance reference format:Company Name:___________________________________Address:_________________________________________Contact Name:_____________________________________Contact Telephone No:_______________________________Contact Fax No:_____________________________________E-mail Address:_____________________________________Contract Number (if applicable):________________________Supplies Provided:___________________________________Service Period:______________________________________Information Comments:_______________________________PRICE:Cost/price will be evaluated for reasonableness. The price must represent what a prudent person would pay when consideration is given to prices in the market. An award shall be made to the offeror whose proposal represents the best overall value to the Government.The Government will evaluate the proposals to determine the price fair and reasonableness in accordance with FAR 13.106-3(a).Offer must be good for 120 calendar days after submission.FOB Destination CONUS (Continental U.S.). Shipping charges shall be included in the purchase cost of the product. Sellers shall deliver the products on their own conveyance to the location listed on the award.RATING METHODSTechnical: Adjective Rating:One of the following ratings will be assigned.TECHNICAL RATINGSRating DefinitionExceptional Greatly exceeds all minimum requirements of the criteria; has a high probability of success; contains no weaknesses or deficiencies.Good Exceeds all the minimum requirements of the criteria; has an above average probability of success; contains no significant weaknesses and only minor, correctable weaknesses exist.Acceptable Meets all the minimum requirements of the criteria; has an average probability of success; no significant weaknesses and any deficiencies can be readily corrected.Marginal Fails to meet one or more of the minimum requirements of the criteria; low probability of success; major weaknesses and/or significant number of deficiencies existUnacceptable Fails to meet any of the minimum requirements of the criteria; proposal needs major revisions; very low probability of success.Past Performance Ratings:One of the following ratings will be assigned.PAST PERFORMANCE RELEVANCY RATINGSRating DefinitionVery Relevant Present/past performance effort involved essentially the same magnitude of effort and complexities this solicitation requires.Relevant Present/past performance effort involved much of the magnitude of effort and complexities this solicitation requires.Somewhat Relevant Present/past performance effort involved some of the magnitude of effort and complexities this solicitation requires.Not Relevant Present/past performance effort did not involve any of the magnitude of effort and complexities this solicitation requires.The combination of relevancy and recency, and performance documented by the information collected by the Government, will result in one of the following ratings:PAST PERFORMANCE RATINGSRating DescriptionAcceptable Based on the offeror's performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort, or the offeror's performance record is unknown (See note below.).Unacceptable Based on the offeror's performance record, the Government has no reasonable expectation that the offeror will successfully perform the required effort.SECTION VI - CONTRACT CLAUSES AND ADMINISTARTION DATA, See attachment 18-247-SOL-00012-2SECTION VII - PROVISIONS, See attachment 18-247-SOL-00012-2