6515--CUSTOM CATARACT SURGICAL PACK

This is a SOURCES SOUGHT for the Asheville NC VA Medical Center. Information collected during this Sources Sought may be used in a set aside. If a solicitation is issued, the Government will do so in accordance with Federal Acquisition Circular (FAC) 2022-04. The North American Industry Classification System (NAICS) number is 339112. The NAICS size is 1,000 employees. Any contractor that believes they are capable and desires to claim preference for small business status must be registered with the SBA at http://web.sba.gov/pro-net/ and meet the requirements of FAR 19.102. Any contractor that believes they are capable and desires to claim preference for veteran owned small business status must be registered with the VIP at https://vetbiz.va.gov/ as an SDVOSB or VOSB. A Contractor that proposes to provide a supply that is not manufactured by their organization (nonmanufacturer) shall meet the requirements of FAR 19.102(f). Contractors that deem themselves capable of meeting the requirement shall provide the below information to, Contract Specialist John Harmsen at [email protected] no-later-than Tuesday, June 9, 2022, at 12:00PM, EST, referencing 36C24622Q0661. Responses shall include: (1) Business Name and Address, (2) GSA/FSS/NAC Contract Number, if applicable (3) Point of Contact Name, Phone Number and E-mail Address (4) SAM # and NAICS code (5) Business Size SMALL or LARGE (6) Type of Business: service disabled veteran owned, veteran owned small business, 8a, HUBZone, woman-owned, etc. (7) A concern that is not a manufacturer of the supply shall provide the manufacturers name and size standard. If the concern is the manufacturer and the sole distributor, please provide documentation to that effect. Contractor must be registered with https://www.sam.gov To be considered SDVOSB/VOSB, must be registered in VIP http://web.sba.gov/pro-net/ Supplies are to include only a Trade Agreements Act, Free Trade Agreement Act or other covered trades act and Buy America Act compliant items. Items that are not TAA/BAA compliant must be clearly identified by the Contractor should the contractor choose to offer a quote if a RFQ is published. FOB is Destination. Delivery is to: Asheville VA Medical Center 1100 Tunnel Rd, Asheville, NC 28805. Please e-mail John Harmsen at [email protected] if you are capable of meeting this requirement. CUSTOM SURGICAL PROCEDURE PACKS CHARLES GEORGE VA MEDICAL CENTER (CGVAMC) STATEMENT OF WORK 1.0 BACKGROUND This is a firm-fixed price Purchase Order (PO), under which the contractor shall provide for the production and delivery of individualized custom procedure packs to be utilized by the CGVAMC in Asheville, North Carolina. The Custom Sterile Procedure Pack Program will include pack assembly/manufacture, sterilization, quality assurance, and packaging, contractor electronic communication ordering reporting, and delivery. Orders will be made for the custom trays as identified in Attachment 1 Pack Contents. All aspects of pack assembly, packaging and sterilization must adhere to the quality control standards set by the FDA. 2.0 SCOPE The Contractor shall provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations, to provide a Custom Sterile Procedure (Cataract) Pack for the Charles George VA Medical Center. The Government is seeking a Base Year plus four Option Years contract with the following Periods of Performance (PoP): Base Year: 1 June 2022 31 May 2023 Option Year 1 1 June 2023 31 May 2024 Option Year 2 1 June 2024 31 May 2025 Option Year 3 1 June 2025 31 May 2026 Option Year 4 1 June 2026 31 May 2027 3.0 IMPLEMENTATION PLAN The contractor shall submit a plan to the Contracting Officer (CO) and Contracting Officer s Representative (COR) outlining how it intends to implement the Custom Sterile Procedure Pack program within 30 calendar days after receipt of award notification. If the initial plan is disapproved, the contractor shall provide corrected plans, using the same time period above, until approved by the CO (1) During the implementation period, the contractor shall validate pack configuration to ensure compliance with facility specifications. Validation shall consist of, but not be limited to the following tasks: Configuration of components from Contract/Solicitation. Production of First Article Packs shall be required at the request of the COR. The disposal of the first article pack shall be the responsibility of the contractor. Delivery of first articles for testing and approval. Production of approved packs upon confirmation from the COR and CO. 4.0 TRANSITION PLAN 4.1 The Government intends to make awards at least 60 calendar days prior to the expiration date of any existing orders/contracts, or options thereof, which the new contract award(s) will replace. Full contract conversion means that the packs requested are available for delivery by the contractor. To ensure full contract conversion time has been allowed for continuity of supplies at required quality levels as well as anticipated inventory levels. Contract(s) shall begin no later than 60 calendar days from the date of award. The CGVAMC may have current inventory that will have to be exhausted prior to placement of orders, therefore orders for some packs may occur outside of the 60 day timeframe but the contractor shall be prepared upon request of new orders no later than 60 calendar days from award. 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 within 30 days of contract award and within two weeks of any pack conversion. 5.0 ORDERING The delivery order will be fully-funded within the limitations of fiscal law for Government contracts and the financial regulations of the Veteran s Health Administration (VHA). Orders will be made in accordance with the Ordering Procedures found in paragraph 6 of this SOW. 6.0 ORDERING PROCEDURES 6.1 Requests for delivery shall be issued by facsimile or electronic commerce methods, and only by the VA facility Points of Contact (POC), for the Contract Line Item Number (CLIN) Series outlined in the schedule of items identified in the awarded contract. 6.2 Requests for delivery shall contain at a minimum the following information: 6.2.1 Date of order; 6.2.2 CLIN, Description, Quantity, Unit Price, and Total Amount; 6.2.3 Delivery or Schedule; and 6.2.4 Place of Delivery 6.3 Upon receiving a request for delivery from the Facility POC, the Contractor shall deliver within two (2) business days for standard deliveries and within 24 hours for emergency deliveries, unless otherwise stated in the delivery order. 6.4 The Contractor shall have full-time representation to receive requests for delivery. The Government shall place delivery orders to the following: (Offeror to complete) a. Contact Person: b. Telephone Number: c. Fax Number: d. Department: e. Address: 7.0 PRODUCTION AND SUPPLY 7.1 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 an anticipated monthly usage. The Government may not obligate funds for product in inventory or production whenever the contract is terminated. The Contractor shall complete component pack changes within 30 days. Due to the possible need for changes, the Government shall be obligated to only a 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 contract, the Government will not be held responsible to procure the additional inventory. In the event of component changes in any pack, the Government agrees to purchase up to a maximum 30 day usage of the current pack composition before the new pack composition is shipped. 7.2 Changes to Composition/Components of Procedure Trays 7.2.1 The CGVAMC may change individual component parts of the tray/pack after an initial thirty (30) days of usage. Pricing and recommended requested changes will be forwarded to the Contractor by the Facility POC. The Contractor shall be required to consider all component part changes and provide a price estimate of each item to be changed. The price proposal will include price plus an estimate for credit for deleted items. In accordance with (IAW) 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 contract. Changes will be made by contract modification/supplemental agreement. 7.2.2 A Pack Change Worksheet shall be utilized for all pack changes. The change form shall include all of the components, quantity and manufacturer detail for the affected pack, including added items and subtracted items. The format of this form is at the discretion of the contractor, to be approved after award or at time of use. 7.2.3 The sales representative (or equivalent) shall supply the Facility POC with the completed change form. With the agreement of the two parties, each shall sign the change form. 7.2.4 The signed change form shall be forwarded to the CO. 7.2.5 Once approved by the CO, the CO will issue a contract modification/supplemental agreement; the change shall be submitted to the Contractor for the next production run of that pack. 7.2.6 The Contractor shall provide the facility with an electronic inventory report each month, which details: the number of packs on order, the current forecast, the three months average usage, the six-month average usage, the number of packs per case, and the cost of the pack. Trends must be communicated between the sales representative and the Facility POC with a mutual determination to adjust inventory levels. 7.2.7 The arrangement of the component parts in the tray/pack shall be coordinated by both the designees and the Facility POC. This coordination shall be prior to production by the Contractor. 7.2.8 Substitutions of items shall not be made without prior approval, in writing, to the Facility POC and approved by the CO via contract modification. 7.2.9 The Contractor s Quality Assurance shall verify changes and ensure the product meets the Government specification. When additions or deletions occur, the Contractor shall provide the CO with the costs of each individual component added or deleted at the time of the change or before written authorization by the CO. 7.2.10 It is reasonable to expect usage and/or requirements may change during the contract period. The Government reserves the right to negotiate with the Contractor to add and/or delete item(s) to pack components. 7.2.11 If for any reason the Contractor is unable to deliver the agreed upon packs, the contractor will provide (12) hour notice to the Facility POC. The contractor will find an alternative source and initiate a backup plan. 8.0 DELIVERY REQUIREMENTS 8.1 All deliveries will be made FOB Destination to the CGVAMC. Supplies shall be delivered to the destination warehouse unloading platform, or receiving dock, at the expense of the Contractor, except in the case of certain emergency orders. The Government will 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. 8.2 Pack deliveries shall be made within two (2) business days after receipt of order (ARO). 8.3 The contractor shall maintain, at a minimum, a 97% fill rate for all orders. Fill rates are calculated as described below. The contractor shall furnish fill rate reports quarterly to the contracting officer and the contracting officer shall independently verify the contractor s fill rate based on utilization data. 8.4 Fill-Rate Calculation. The contractor shall individually calculate the fill rate on a quarterly basis, based only on those packs ordered by the medical center, for which the contractor has been authorized to deliver. The Fill-Rate Level will be calculated as follows: 8.4.1 Fill Rate = Packs accepted by the Government / (Total Packs ordered Contractual Exceptions) 9.0 PACKAGING 9.1 Unless otherwise specified in the SOW, 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 ensure acceptance and safe delivery by common carriers 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 clearly labeled on the outside covering if they contain latex products. However, all products should be totally latex free, except where authorized by the Facility POC. 9.2 Each pack shall have a label specifying the manufactured date and sterilization 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, as well as any missing items that were approved to be left out by the Facility POC. Pack contents list must contain item, quantity, and country of origin information. Color coded packs, or some sort of visual cue to distinguish between pack types must be available upon request by the Facility POC at no additional charge. Expiration dating of all custom sterile procedure packs delivered under this program shall have a minimal shelf life of 12 months remaining upon delivery to the Government. Delivery of short-dated products may be approved as situations arise. 9.3 Each pack shall also have a separate label on the outside of the pack that includes the ordering station number and station specified pack name. 9.4 All outer shipping packages shall contain the complete contract number and delivery order number in addition to the shipping address. 9.5 Package content quality is the responsibility of the prime contractor, including items affixed to the outside of the pack (piggyback) and distributed as a part of the pack. 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. 9.6 The VHA is currently implementing Real Time Location Services (RTLS) throughout its Medical Centers nationwide. One component of the RTLS project includes cardiac catheterization lab supplies using RFID smart cabinets. The purpose is to track those high cost items for increased supply chain visibility and track invasive supplies using a unique device identifier to associate those supplies to a patient through a direct link with our Cart-CL documentation software. The application and use of RFID may expand beyond the CATH lab in future years. Cabinets currently in use include those manufactured by WaveMark, Solstice, and Terso. Where RFID Tags are specified, tags shall be Global Standards 1 (GS1) compliant and must be available in both UHF and HF technologies, as specified by the CGVAMC. Tags will be placed either on specified components or the packs, at the discretion of the ordering facility. 10.0 MANUFACTURING 10.1 STERILIZATION AND ASSEMBLY 10.1.1 The contractor shall ensure an individual lot number for each custom sterile procedure pack is assigned for clear tracking of all packs. The packing list shall include the manufacturer and lot number of each component item to ensure traceability. The contractor shall meet the following assembly and sterilization requirements: 10.1.2 The contractor shall validate the sterilization process, with the Association for Advancement of Medical Instrumentation (AAMI) at a minimum annually. The Contractor shall send the validation to the CO within 30 days of annual inspection completion. 10.1.3 All Component debris, sterility tests, and residual tests are to be performed by contract laboratories at contractor s expense. 10.1.4 The contractor shall guarantee prior to sterilization, the products shall be assembled in secure air controlled rooms, which are accessible only to authorized personnel with proper attire. International Association of Healthcare Central Service Material Management (IAHCSMM) (https://www.iahcsmm.org) and Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) provide guidelines for proper attire. 10.1.5 The Contractor shall follow current ISO (International Organization for Standardization) for Sterilization of health care products. 10.1.6 The contractor shall guarantee all aspects of the assembly, packaging and sterilization must adhere to the quality control standards set by the FDA. The Contractor (all entities in the production process) shall be registered with the FDA. 10.1.7 In accordance with the Executive Order 13514, dated October 5, 2009, the Contractor should consider earth friendly solutions, and provide a program that supports green purchasing. Contractor should provide a recycling program for re-useable items that are salvageable and recommend green product components when available. 10.1.8. The Contractor shall not provide re-sterilization of any single use product for resale to the VA. 10.1.9 The Contractor shall have in-house sterilization capability or have, the ability to provide sterilization services at all times. The in-house or contract sterilization partners shall be ISO9001:2000 (International Organization for Standardization) certified and undergo routine FDA inspections. 10.1.10 The contractor shall inspect all component products and check for damage and short dates. 10.1.11 The Contractor shall have continual maintenance performed on all sterilizing equipment. 10.1.12 The contractor shall provide quality assurance staff which shall include personnel familiar with operating room procedures, infection control practices, aseptic techniques and sterilization methods. 11.0 TRAY/BUNDLE CONSTRUCTION 11.1 All component items required for the tray/pack are to be provided by the Contractor. All component packaging will be removed from outer packaging to reduce steps in the operating/procedure room, unless otherwise required by the customer or the component manufacturer. 11.2 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. Biodegradable trays that have the same affect are acceptable. ETO tape/indicator is to be affixed to the outer wrap and tray where applicable. All custom packs should be sterilized in an approved packaging material with a plastic dust cover. Custom packs material must allow the sterilization of the contents, maintain sterility, and provide a way to remove the contents without contamination. Plastic dust covers should be sealed with a method of sealing which results in a complete seal that is tamper evident and allows for ease of aseptic presentation. Accessories used to secure custom packs should be chosen to allow penetration of the sterilization process, avoid constriction of the package and maintain package integrity. 12.0 NONAVAILABILITY OF COMPONENT PARTS 12.1 Should a component part become unavailable which will temporarily or permanently delay the production of the pack(s), the Contractor shall immediately notify the Facility POC 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. 12.1.1 At a minimum, the unavailability notification shall include the following information: 12.1.1.1 Complete item description, (product and lot number) and/or identification 12.1.1.2 Contract and Delivery Order 12.1.1.3 Reason for unavailability 12.1.1.4 If a direct recall was issued, the contractor shall include the manufacturer disposition instructions and level of recall. 12.2 Recalls: In accordance with the Safe Medical Device Act, (SMDA) the Contractor shall have a documentation system for component product traceability and lot number recordings for product recalls. The Contracting Officer and Facility POC must be notified immediately by telephone (with written notice to follow within five (5) calendar days) if affected by a product recall. The contractor shall also provide a method of identifying affected packs on the shelf such as a brightly colored sticker or other visual identifier within 24 hours so that VA may mark the existing pack identifying the recalled component(s). Vendor existing inventory will be marked using the same method provided to VA staff. If the recalled component is unavailable for further production of the custom sterile procedure pack(s), no substitutions will be made by the Contractor without written authorization of the CO. Pack conversions in the result of a recall shall adhere to the same timelines for change out as all other pack conversions. 12.3 The contractor shall notify the Facility POC and the CO of any Manufacturer Backorder (MBO). The status clearly states the reason for any unavailability of component parts due to MBO and shall indicate the length of time for replenishment by product supplier. The government retains the right to investigate the backorder situation to determine the cause of the backorder and to provide assistance to the Custom Sterile Procedure Pack contractor and the participating customers during the MBO period. 12.4 No deletions or substitutions will be made without written authorization from the Contracting Officer or delegated representative. 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 CO or Facility POC. The cost of the pack must be adjusted to reflect the change. In addition, the content listing will clearly identify any missing items approved to be left out by the VA. 13.0 QUALITY ASSURANCE 13.1 The Custom Sterile Procedure Pack manufacturing facilities must be registered and in good standing with The FDA and ISO9001:2000 certified 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. 13.2 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, 21 CFR 820 (Code of Federal Regulations), EN 46001, and United States regulations regarding the sales and distribution of medical products. At a minimum ISO9001:2000 Certification must be available at time of proposal submission, and continuously maintained throughout the duration of the contract. 13.3 The Government may, at its option and expense, request an unrelated third party to inspect the packs provided by the Contractor. The Contractor shall repair, at the Contractor s cost, any faults or omissions discovered by the inspection of the third party within fifteen (15) days when notified by the Facility POC. 13.4. The Government may, at its option and expense, inspect the contractor s manufacturing and distribution centers at least annually, within five working days upon request by the Facility POC. 14.0 DELIVERABLES The following table summarizes the deliverables outlined in this SOW. Document Title SOW Section Format Frequency AAMI Sterilization Annual Inspection Certificate SOW Section 11 AAMI's format Within 30 calendar days after annual inspection completion 15.0 PERFORMANCE MEASURES The following table summarizes the means by which contractor performance will be measured during the ordering period of the base IDIQ contract. Measures will be used to assess performance prior to exercising options and may be used in the submission of CPARS evaluations. Title Description Metric Note: Order Fill-Rate The contractor shall make delivery on all orders under this contract, within the terms of SOW Section 6 97% fillrate See SOW Section 6 for the method of calculation. Fill-Rate may be calculated at any time to verify if performance problems exist, but will likely be conducted once, annually, prior to option exercise. Order Accuracy The contractor shall make accurate deliveries. Accuracy is defined as delivering the correct types and quantities of bundles, as ordered. 97% Accuracy of all delivered items This metric will be calculated as: Accurate items/(Total items delivered- Contractual Exceptions). This metric may be calculated at any time to verify performance problems exist, but will likely be conducted once, annually, prior to option exercise. Pack Contents Accuracy A bundle that is missing a required component(s), by type or quantity will be considered one inaccurate item within the ordered inventory. 97% accuracy of all delivered surgical packs. This metric will be calculated as: Perfect Bundles/(Total Bundles delivered-Contractual Exceptions). This metric may be calculated at any time to verify if performance problems exist, but will likely be conducted once, annually, prior to option exercise 16.0 INVOICING 16.1 The Contractor shall submit invoices for routine requests as the requests are made and fulfilled. 16.2 Emergency deliveries will be invoiced under a separate obligation, for deliveries made in the previous month, through obligation to cover costs incurred in a future period, or through the use of Government Purchase Card for individual deliveries, as they occur. 17.0 GOVERNMENT-FURNISHED EQUIPMENT AND PROPERTY 17.1 No Government-furnished equipment or property is provided under this contract. Qty Mfg Description Alcon Parts 1 0065079515 BSS 15ML 2 80420020NS CANNULA,ANT CHAMBER,30G 4MM BEND TO TIP 1 200021351 CEN ACT .9 ULTRA 45BAL NO TRAY 2 8065-1038-99 DRAPE,FRONT PANEL,22X18 1 8065752885 INTREPID TRANSFORMER IA HP 1 8065977763 MONARCH III CARTRIDGE D 1 8888501246 SHIELD,EYE,PLASTIC,CLEAR 1 0065041130 SOLUTION,BETADINE 5% 30ML Non Alcon Parts 1 DRAPE,OPH,INCISE,51X51,W/PCH 1 CYSTOTOME,IRR,27G,ANGL 1 WIPE,INSTRUMENT,W/DRAIN 1 KNIFE,2.4MM,SLIT,45'ANG,DB,SAF 1 KNIFE,SIDE PORT,XSTAR,ANG,SAFE 2 NEEDLE,22GX1-1/2 2 SYRINGE,1ML,LL 3 SYRINGE,3CC LL 18 LABEL,WHITE,7/16X1-1/2 1 CANNULAR,ANT CHAMBER,20GA 2 CANNULA,ANT CHAMBER,27G,6MM 3 APPLICATOR,COTTON,WOOD,3",10S 1 COUNTER,NEEDLE,40-80,FOAM/MAG 2 GOWN,XLARGE,NON REINFORCED 1 GOWN,XLARGE,NR,W/TOWEL,WRAPPED 1 SYRINGE,10CC/12CC,LL 10 TOWEL,CLOTH,BLUE 2 TRAY,1PART,10X5X2,RECYCLABLE 1 TRAY,1PART,15X11X1,RECYCLABLE 2 WRAP,POLY/TISSUE,28X28 10 SPONGE,GAUZE,12PLY,4X8 10 SPONGE,GAUZE,16PLY,4X4 2 BOWL,SPONGE,NO LID,8OZ/250CC 3 COVER,ARM CHAIR 2 CUP,MEDICINE,2OZ/60CC 2 SPEARS,EYE,I SPEAR,6S 2 PAD, EYE, 1-5/8X2-5/8 OVAL 1 CANNULA,HYDRODIS(CHANG),27GX3/ 1 SKINMARKER,DUAL,TIP,PERM