6515--Tandem Autosoft Infusion Sets

?.## Pharmaceutical Statement of Requirements VA FORM 2237 #765-23-1-021-0002 AUTOSOFT TANDUM INFUSION SETS for HINES CMOP DELIVERY TERMS The Government reserves the right to cancel any quantities NOT delivered on or before the required date as specified in solicitation and purchase order. All products supplied under this contract must be shippable by the United States Postal Service (USPS) unless specifically identified otherwise by the vendor and accepted by the Contracting Officer. Failure of the vendor to notify the Contracting Officer of the non-shippable status of a product (usually due to flammability) will result in cancellation or return of the product at the offeror s expense. Shippable means the product must able to be shipped by the USPS when the Consolidated Mail Outpatient Pharmacy (CMOP) issues it to a patient. It DOES NOT mean that the product supplier must ship the product to the CMOP via USPS. The most cost effective method of shipping should be used for initial

delivery to the CMOP. For reconciliation purposes, all shipments must reference the original VA obligation number (i.e., 770A712345) even if purchased product is from another partnered company. This obligation number is referenced by CMOP receiving facility to verify receipt of items, and by the VA Fiscal Service Center to pay invoices submitted by vendor. Deliveries are to be coordinated by shipper with receiving CMOP facilities) to ensure deliveries occur within operational hours. Delivery may be required to multiple delivery points as specified on solicitation and purchase order. The contractor is to email tracking information to points of contact listed on Delivery Schedule in Section B of the solicitation and purchase order upon shipment of products. Carlos.Araghi@va.gov. ADDITIONAL TERMS PROPOSED BY CONTRACTOR: Any alternate National Drug Codes (NDCs) that vendors wish to quote shall be listed on the attached quote spreadsheet (where applicable). Acceptance prior to purchase order of any vendor-quoted NDC or Universal Product Code (UPC) shall be contingent on CMOP approval. If a line item indicates more than one NDC/UPC, vendor SHALL specify which NDC/UPC is used when quoting. If offering an alternate, vendor MUST indicate proposed alternate on the attached quote spreadsheet in the column titled ALTERNATE NDC (PKG SZ) and indicate bottle size in parentheses (i.e., 500 CT). ALL OFFERS SHALL BE SUBMITTED ON THE ATTACHED QUOTE SPREADSHEET. If the pre-approved alternate NDC is provided by the vendor, and if the unit size is different from the original unit requested, then the vendor must also adjust the final quantity accordingly. For example: Solicitation is for 100 quantities of 1000 CT bottles. Vendor submits quote for 500 CT. Quantity would need to be changed to 200. The quoted alternate terms or conditions shall be reviewed by the Contracting Officer and, if accepted, shall be included in the resulting purchase order. Alternate terms and conditions quoted elsewhere will not be considered, and will not be included in any resultant purchase order. BAR CODING All pharmaceutical products provided under the resulting purchase order shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC), Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC parameters including, but not limited to symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements. The bar code may be any linear bar code symbology, such as GS1-128 (formerly EAN.UCC), GS1 Data Bar (formerly RSS), or Universal Product Code (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN)). The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits, to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this section prior to shipping pharmaceutical products to any authorized ordering activity under this contract. The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the overwrap, the overwrap must contain the bar code. The bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus, it must not be printed across the perforations of a blister pack. When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in ladder orientation on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging. It is recommended that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date, the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Management Association (HDMA) guidelines shall be followed. THERAPEUTIC EQUIVALENCE Only products that have received, under the Federal Food, Drug and Cosmetic Act (FFDCA), a therapeutic equivalence code of A by the Food and Drug Administration (FDA) will be considered, unless all drugs in the family group are B rated. In that case, no purchase order will be made other than to the innovator unless the non-innovator offeror submits acceptable data demonstrating bioequivalence. RECALLS -- THIS IS FOR FSS ONLY If a drug recall is initiated for any drug provided under the resulting purchase order, regardless of whether it is a voluntary recall by the manufacturer or a recall required by FDA, or, if FDA withdraws their approval to manufacture any drug that is included on this purchase order, the following action shall immediately be taken by the vendor: Forward two (2) copies of the recall notification along with any pertinent information to: 1) Chief, Pharmaceutical Federal Supply Schedule Service (003A4B) VA National Acquisition Center P.O Box 76 Hines, IL 60141 Fax number: (708) 786-4974 2) Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Fax number: (708) 786-7894 3) Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5865 4) All authorized ordering activities that were sent shipments of the affected product(s). 5) All FSS ordering activities that were sent shipments of the affected product(s). RECALLS -- THIS IS FOR OPEN MARKET ONLY If a drug recall is initiated for any drug provided under the resultant purchase order, regardless of whether it is a voluntary recall by the manufacturer or a recall required by FDA, or, if FDA withdraws their approval to manufacture any drug that is included on the resultant purchase order, the following action shall immediately be taken by the vendor: Forward two (2) copies of the recall notification along with any pertinent information to: 1) Director, CMOP Acquisitions Veterans Health Administration Network Contracting Office (NCO15) 3450 South 4th Street Leavenworth, KS 66048-5012 Fax Number: (913) 684-0179 2) Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Fax Number: (708) 786-7894 3) Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5865 4) CMOP address shown in Block 15 of the Standard Form (SF) 1449 of the resultant purchase order. NATIONAL DRUG CODES Offerors shall provide a separate and distinct eleven-digit National Drug Code (NDC) number (e.g., 00012-3456-78) for each product proposed on the attached quote spreadsheet of the solicitation. Quotes that fail to provide the information required by this section by the solicitation closing date shall be rejected and shall receive no further consideration. FIRM COMMITMENT OF PRODUCT AVAILABILITY AND PRICE Just prior to purchase order, usually 24-hours, the Offeror shall be required to provide a firm commitment of availability and price. This commitment may be in the form of an email certifying availability or other document illustrating or showing availability. OTHER REQUIREMENTS Any package size ordered below 500 count is considered to be for Unit of Use issue and requires a Safety/Child Proof cap. The expiration dates of the pharmaceutical(s) shall be no less than 12 months from date of delivery. Substitutions of pack sizes must be approved in writing by the Contracting Officer prior to shipment Any change that deviates from the specific item requested must be approved by the Contracting Officer in writing. For example, the replacement of capsules for tablets or suspended action for extended release items will require approval prior to shipment. Partial deliveries of product must be approved in writing by the Contracting Officer prior to shipment Minimal lot numbers of product is required. More than three (3) lot numbers of product must be approved by the Contracting Officer in writing prior to shipment. A minimum bottle size is 100cc with a child safety type cap that does not exceed the diameter of the bottle. It must also have a cylindrical body and minimum of 5.75-inches circumference. It is incumbent upon the vendor to initiate any actions requiring the approval of the Contracting Officer. Failure to obtain Contracting Officer approvals may result in termination of purchase order in accordance with Federal Acquisition Regulation (FAR) clause 52.212-4 (Contract Terms and Conditions Commercial Items) as specified in solicitation and purchase order. All shipments shall come with a packing slip identifying Vendor name/address, VA Purchase Order Number (i.e., VA770-17-P-1234), VA Obligation Number (i.e., 770A12345), NDC, PRODUCTS, and LINE ITEM NUMBERS from the purchase order document. Documentation shall include Vendor s point of contact for reporting noted discrepancies, damages, or incorrect product. Invoice price must match purchase order price. Failure to supply this information may cause a delay with payment or rejection of the product if the order information is not readily apparent. All like products shall be packaged and shipped together. Breakable items shall be packaged appropriately with blister pack or bubble wrap. Requirements meeting case pack size will be shipped in the original manufactures packaging. Quantities less than case size may be shipped in repack boxes but must be clearly marked as repacks Vendor shall provide a return authorization and pickup for any damaged products or incorrect products received within one (1) week of request. For Awarded Vendor(s) Only to Complete DRUG SUPPLY CHAIN SECURITY ACT COMPLIANCE THIS APPLIES TO PRESCRIPTION PHARMACEUTICALS PROCUREMENTS ONLY www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm As of January 1, 2015, all suppliers of prescription drug products (i.e., products which have been approved and which may be dispensed only by prescription under section 503(b) of the FDCA), must comply with the provisions of The Drug Supply Chain Security Act (DSCSA), and all trading partners must be authorized as defined by this act.. The documentation must be provided with the product or prior to receipt and documentation must comply with the DSCSA. The documentation can be paper-based or electronic (i.e., Electronic Data Interchange [EDI], Electronic Product Code Information Services [EPCIS] or Abstract Syntax Notation [ASN] file format) to meet the requirements of the DSCSA. The TH (Transaction History), TI (Transaction Information) And TS (Transaction Statement) may be submitted by e-mail to the following group or groups as appropriate: VHACMOPProcurement/Logistics760@va.gov (Leavenworth CMOP) VHACMOPProcurement/Logistics761@va.gov (Chelmsford CMOP) VHACMOPProcurement/Logistics762@va.gov (Tucson CMOP) VHACMOPProcurement/Logistics763@va.gov (Dallas CMOP) VHACMOPProcurement/Logistics764@va.gov (Murfreesboro CMOP) VHACMOPProcurement/Logistics765@va.gov (Hines CMOP) VHACMOPProcurement/Logistics766@va.gov (Charleston CMOP) VHACMOPProcurement/Logistics770@va.gov (National CMOP) The documentation required is as follows: Transaction History (TH) A paper or electronic statement shall include the transaction information for each prior transaction for the subject product going back to the manufacturer of the product. Transaction Information (TI) A paper or electronic document containing: the proprietary or established name or names of the product; the strength and dosage form of the product as stated on the manufacturers label the National Drug Code number of the product; the container size; the number of containers; the lot number of the product; the date of the transaction; the date of the shipment, if more than 24 hours after the date of the transaction; the business name and address of the person from whom ownership is being transferred; and the business name and address of the person to whom ownership is being transferred. Transaction Statement (TS) A paper or electronic document stating, that the entity transferring ownership in a transaction: is authorized as required under the Drug Supply Chain Security Act; received the product from source that is authorized as required under the Drug Supply Chain Security Act; received transaction information and a transaction statement from the prior owner of the product, as required under section 582; did not knowingly ship a suspect or illegitimate product; had systems and processes in place to comply with verification requirements under Section 582; did not knowingly provide false transaction information; and did not knowingly alter the transaction history.