Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as su... This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. VA will conduct the procurement according to a combination of FAR Part 12, Acquisition of Commercial Items and Part 13, Simplified Acquisition Procedures as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 36C24522R0003 and is issued as a Request for Quotation (RFQ). (iii) The provisions and clauses incorporated into this solicitation document are those in effect through Federal Acquisition Circular 2021-07, fiscal year 2021. Provisions and clauses incorporated by reference have the same force and effect as if they were given in full text. The full text of the Federal Acquisition Regulations (FAR) and Veterans Affairs Acquisition Regulations supplement (VAAR) can be accessed on the Internet at http://www.arnet.gov/far (FAR) and http://vaww.appc1.va.gov/oamm/vaar (VAAR) (iv) This requirement will be set-a-side for Service-Disabled Veteran-Owned Small Businesses (SDVOSB). The North American Industry Classification System (NAICS) code is 325412, Pharmaceutical Preparation Manufacturing and the size standard is 1,250 employees. (v) VA Capital Health Care Network VISN 5 is seeking to establish a Multiple-Award Blanket Purchase Agreement (BPA) for Pharmaceuticals for a period of 5 years. This requirement consists of seventeen (17) line items: Item# Description/Dosage National Drug Code 1 Vigabatrin (Sabril) 500mg 67386-0111-01 2 Desmopressin (Stimate) 0.2mg 68462-0276-01 3 Treprostinil (Tyvaso) 0.6mg/(2.9ml) Kit 66302-0206-1 4 Alpha -1 proteinase Inhibitor (Zemaira) 1000mg 00053-7201-02 5 Alemtuzumab (Lemtrada) 12mg/1.2mg (10mg/ml) 58468-0200-1 6 Deferiprone (Ferriprox) 500mg 52609-0006-01 7 Deferiprone (Ferriprox) 500mg 52609-0007-05 8 Glutamine (Endari) 5 gram 42457-0420-60 9 Methadone Tab 40mg 00054-8538-25 10 Methadone tab 10mg 00054-4571-25 11 Methadone Liquid Cherry Oral 1000ml 00406-0527-10 12 Amifampridine (Firdapse) 10mg 69616-211-08 13 Immune Globulin (Hizentra) 2gm/10ml 44206-452-91 14 Immune Globulin (Hizentra) 4gm/20ml 44206-454-92 15 Immune Globulin (Hizentra) 10GM/50ml 44206-045510 16 Valbenazine (Ingrezza) Capsule 40mg 70370-1060-1 17 Valbenazine (Ingrezza) Capsule 80mg 70370-1080-1 STATEMENT OF WORK General Description: The purpose of this solicitation is to establish a VISN level Blanket Purchase Agreement (BPA) to be utilized throughout Veterans Integrated Service Network (VISN 5).  VHA Pharmacy Services are essential components of VA s health care system. The safe, appropriate, and cost-effective use of medications is the overarching goal of VA pharmacy programs. Deliveries will be made Monday through Friday from 8:00 am to 4:00 pm. Contractor shall provide emergency deliveries as requested by the VA Pharmacy Departments. Personnel assigned by the contractor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. Government Requirements: Drug Supply Chain Act (DSCSA) Compliances http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm424963.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 the act. The documentation must be provided with the product or prior to receipt and documentation must comply with DSCSA. The documentations 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) 3T Data. Refers to the Transaction History, Transaction Information, and Transaction Statement as defined in the DSCSA. Transaction History (TH) A statement, in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product. Transaction Information (TI) The components required to be present on the transaction statement include: Proprietary or established name(s) of the product Strength and dosage form of the product National Drug Code number of the product Container size Number of containers Lot number of the product (not necessary if shipped directly from the manufacturer to the vendor transferring it to the pharmacy) Date of transaction Date of shipment (if more than 24 hours after date of the transaction) Business name and address of the trading partner from whom ownership is being transferred Business name and address of the trading partner to whom ownership is being transferred Transaction Statement (TS). A statement, in paper or electronic form that the entity transferring ownership of a product in a transaction provides to the entity receiving ownership of the product. It contains the following information: A statement that the transferring entity is authorized as required under the DSCSA Received the product from an entity that is also authorized under the DSCSA Received 3T information from the prior owner of the product (if applicable) as required under section 582 of the DSCSA Did not knowingly ship a suspect or illegitimate product Had systems and processes in place to comply with the verification requirements under section 582 of the DSCSA Did not knowingly provide false transaction information Did not knowingly alter any previous 3T information Barcoding 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 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 If a drug recall is initiated for any drug provided under the resultant purchases order, regardless of whether it is a voluntary recall by the manufacturer of a recall required by FDA, or FDA withdraws their approval to manufacture any drug that is included on the resultant purchases order, the following action shall to taken by the vendor. Immediately upon receiving notice of the recall, the company shall notify all customers electronically receiving distribution of the product under this BPA using the most expeditious manner. The subject line shall include the name of the product being recalled. The company shall not ship recalled products to the customers. Expeditiously notify the following management offices of the Department of Veterans Affairs. Forward two (2) copies of the recall notification along with any pertinent information to: Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, Il 60141 Fax Number: (708) 786-7894 Manger, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPRSRecallsNotification@va.gov Phone Number: (734) 930-5865 At a minimum, the recall notification shall include the following information: Complete item description, (product number & lot number) and / identification along with the manufacturer and national drug code Contract and Delivery Order Number Reason for recall Disposition instructions. If a direct recall is issued, the company shall include the manufacturer disposition instructions. Level of recall The company will provide within their reporting system a report that provides historical data on purchases by the account for a specific item or NDC which will include actual lot numbers and expiration dates. The notification shall provide the product name (generic and trade), and level of recall (if available) must be included in the subject line. The company shall issue credit for any product where specified in accordance with the manufacturer recall. Administration: a.  Contractor shall bill upon acceptance of each delivery. b.  All services rendered will be itemized by date of service, Company will provide, and unit cost.             Security and Confidentiality: a. Responsible for maintaining Automated Data Processing (ADP) security. b. Responsible for maintaining patient information in the strictest confidence in accordance with the Privacy Act.                     Work Hours: The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services on a national holiday or during non-working hours as described below. Work hours: Monday through Friday, 8:00 am - 4:30 pm. Delivery orders that include products classified as controlled drugs: shall be packaged separately from the rest of the delivery order and in accordance with DEA requirements. Delivery orders that include products classified as hazardous drugs: as defined by National Institute of Occupation Safety and Health (NIOSH) and listed on the most current version of the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings must be identified by the company. The company will ensure hazardous drugs are packed and shipped in impervious plastic and packaged separately from the rest of the delivery order to segregate them from other drugs and to allow for safety in the receiving and internal transfer process. In addition, the company will mark or label the outermost packing as NIOSH Hazardous Drug to assist facilities in meeting the compliance requirements and in accordance with ASHP Guidelines on Handling Drug Hazardous Drugs and USP General Chapter <800> requirements. Delivery shall conform to drug integrity and storage as outlined in USP 1079 Delivery inspection and acceptance shall be performed in accordance with FAR 52.212.-4(a). The Government will witness products received at the loading dock ( or specified delivery location) and sign delivery receipt document before company driver departs. Witness of products received in no way waives the Government s rights under FAR clauses 52.212+4(a) Inspection and Acceptance. Ordering: Each authorized ordering facility will be responsible for its own order placement. For the Department of Veterans Affairs, order placement will be made by duly designated (in writing) Ordering Officers and / or warranted contracting staff. Delivery Orders: Orders normally will be placed by 5 p.m. delivery shall be required by 8:00 am the following workday. Due to the demands of the Medical Center care requirements, there shall be no restriction to the number of orders which may be placed by VA. In the event that the requirements may be determined in advance, a longer delivery time will be scheduled accordingly. The delivery order shall specify contract item (s) and quantity, time (s) of delivery and applicable VA obligation number. Orders can be placed orally by telephone and/or fax transmission. Delivery Location: VA Maryland Health Care System Beckley VA Medical Center Hershel Woody VA Medical Center- Huntington, WV Louise A. Johnson VA Medical Center- Clarksburg, WV Martinsburg VA Medical Center- Martinsburg, WV Washington DC VA Medical Center Deliveries will be made Monday-Friday (excluding holidays which are listed below) between the hours of 8:00 AM and 4:00 PM, except in the case of emergency. Federal Holidays are as follows and include any other days specifically declared by the President Of the United States to be deemed a holiday. New Year s Day Martin Luther King s Birthday Presidents Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Christmas Day Delivery Commitment: Time of delivery specified or mutually agreed to at the time of receipt of telephone order shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. Person Authorized to Place Orders: In addition to the Contracting Officer, the COR is authorized to place orders under this contract, as well as any Pharmacy procurement Technician employed by the VA Hospital. The services specified herein may be changed by written modification. The modification will be prepared by the VA Contracting Officer. The purpose of this solicitation is to establish VISN level blanket purchase agreement (BPA) utilized throughout Veterans Integrated Service Network (VISN 5). Period of Performance: December 1, 2021 November 30, 2026 The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. (vii) All material shall be delivered to one of the locations listed above. (viii) 52.212-1 Instructions to Offerors - commercial Items, applies to this acquisition. There are no addenda to the provision. (ix) 52.212-2, Evaluation - Commercial Items: FAR provision 52.212-2 does not apply to this solicitation. Award will be based on lowest price and meeting or exceeding Statement of Work requirements. (x) 52.212-3 Offeror Representations and Certifications - Commercial Items- the Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. (xi) 52.212-4 Contract Terms and Conditions - Commercial Items: applies to this acquisition. (xii) 52.212-5 Contracts Terms and Conditions Required To Implement Statutes or Executive Orders - Commercial Items; the following FAR clauses identified at paragraph (b) of FAR 52,204-10; 52.212.5 are considered checked and are applicable to this acquisition: 52.204-10, 52.209-6, 52.219-6, 52.219-8, 52.219-13, 52.219-28, 52.222-3, 52.222-19, 52.222-21; 52.222-26; 52.222-35, 52.222-36, 52.222-50, 52.223-18, 52.225-1, 52.225-3; 52.225-13, 52.232-34. (xiii) 52.217-8 Option to Extend Services, 52.217-9 Option to Extend the Term, 52.52.232-18 Availability of Funds, 52.232-19 Availability of Funds for Next Fiscal Year. Any additional contract requirement(s) or terms and conditions determined by the Contracting Officer to be necessary for this acquisition and consistent with customary commercial practices will be addressed as necessary. (xiv) Proposals/Quotes shall be submitted in writing to Chantey Bost at chantey.bost2@va.gov NLT 1600 on Monday, November 29, 2021. Questions are due NLT 1600 on Tuesday, November 23, 2021 eastern standard time. Quotes shall be submitted on company letterhead. Commercial format is encouraged. All proposals/quotes shall include the following information: Legal Business/Company Name (as it is indicated in www.sam.gov) DUNS Number Contract Number (if applicable) Warranty Information (Can be a separate attachment) Point of Contact Name Telephone number E-mail Address (xvi) Point of contact for this solicitation is Chantey Bost, chantey.bost2@va.gov . Inquires must be in writing via email. FAR Deviation Clause Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors September 30, 2021 PART 52 SOLICITATION PROVISIONS AND CONTRACT CLAUSES ***** Subpart 52.2 Text of Provisions and Clauses ***** [52.223-99 Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors. ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS (OCT 2021) (DEVIATION) Definition. As used in this clause - United States or its outlying areas means The fifty States; The District of Columbia; The commonwealths of Puerto Rico and the Northern Mariana Islands; The territories of American Samoa, Guam, and the United States Virgin Islands; and The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll. Authority. This clause implements Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors, dated September 9, 2021 (published in the Federal Register on September 14, 2021, 86 FR 50985). Compliance. The Contractor shall comply with all guidance, including guidance conveyed through Frequently Asked Questions, as amended during the performance of this contract, for contractor workplace locations published by the Safer Federal Workforce Task Force (Task Force Guidance) at https:/www.saferfederalworkforce.gov/contractors/. Subcontracts. The Contractor shall include the substance of this clause including this paragraph (d), in subcontracts at any tier that exceed the simplified acquisition threshold, as defined in Federal Acquisition Regulation 2.101 on the date of subcontract award, and are for services, including construction, performed in whole or in part within the United States or its outlying areas.