Augusta Bulk Oxygen Service Amendment 0005
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Pre-solicitation Notice The Veterans Health Administration (VHA), Veteran Integrated System Network (VISN) 7, Charlie Norwood VAMC, 1 Freedom Way, Augusta, GA. 30904 is establishing an ongoing require... Pre-solicitation Notice The Veterans Health Administration (VHA), Veteran Integrated System Network (VISN) 7, Charlie Norwood VAMC, 1 Freedom Way, Augusta, GA. 30904 is establishing an ongoing requirement for: Statement of Work Charlie Norwood VA Medical Center (Uptown & Downtown Campuses) Augusta Georgia Medical Grade Bulk Oxygen and Tank Rental 1. General 1.1. Services: This statement of work describes the requirements for leasing a bulk oxygen tank and the purchase of compressed oxygen for the Uptown and Downtown Division of the Charlie Norwood VA Medical Center (CNVAMC), Augusta, Georgia. 1.2. Period of Performance: This is for a one-year base contract with the possibility of four one-year option periods. The base year period of performance is October 01, 2023 September 30, 2024, or date of award. Base Year October 01, 2023 - September 30, 2024 Option Year 1 October 01, 2024 - September 30, 2025 Option Year 2 October 01, 2025 - September 30, 2026 Option Year 3 October 01, 2026 - September 30, 2027 Option Year 4 October 01, 2027 - September 30, 2028 1.3 Place Performance: Charlie Norwood VA Medical Center - UD 1 Freedom Way Augusta, GA 30904 Charlie Norwood VA Medical Center DD 800 Bailie Drive Augusta, GA 30901 1.4 Background: This statement of work describes the requirements for leasing a bulk oxygen tank and the purchase of compressed oxygen for the Uptown and Downtown Division of the Charlie Norwood VA Medical Center (CNVAMC), Augusta, Georgia. The CNVAMC currently has a requirement for the distribution and supply of medical-grade liquid bulk oxygen and tank rental. The requirement is for estimated quantities which may change based on actual need to support patient care, historically, the facility has used quantities up to but has not exceeded the requested amounts. 1.5 Acronyms and Definition: 1.5.1.1. C&A Certification and Accreditation 1.5.1.2. CFR Code of Federal Regulations 1.5.1.3. CNVAMC Charlie Norwood VA Medical Center 1.5.1.4. COR Contracting Officer s Representative 1.5.1.5. CGMP Current Good Manufacturing Practices 1.5.1.6. FDA Food and Drug Administration 1.5.1.7. ISO Information Security Officer 1.5.1.8. NFPA National Fire Protection Association 1.5.1.9. PII Personally Identifiable Information 1.5.1.10. PIV Personal Identification Verification 1.5.1.11. QASP Quality Assurance Surveillance Plan 1.5.1.12. U.S.P. United States Pharmacopoeia 1.5.1.13. VA Veterans Affairs or Department of Veterans Affairs 1.5.1.14. VHA Veterans Health Administration 1.5.2. Publications: 1.5.2.1. 21 CFR Part 201 1.5.2.2. NFPA 50 1.5.2.3. NFPA 99 1.5.2.4. VA Handbook 6500.1 1.5.2.5. VA Handbook 6500.2 1.5.2.6. VHA Handbook 2005-028 1.5.2.7. VHA Patient Safety Alert 2. Personnel 2.1. Key Personnel: Name Position License / Certification /Experience Percentage of Work Under Contract 3. Hours of Operation: 3.1. Business Hours 8:00am 4:30pm, Monday Friday, excluding Federal Holidays. Federal Holidays New Year s Day January 1st Martin Luther King s Birthday 3rd Monday in January President s Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran s Day November 11th Thanksgiving Day Last Thursday in November Christmas Day December 25th 3.1.2. Work schedule The Contractor shall be available during normal business hours of 8:00am 3:30pm, Monday Friday, excluding Federal Holidays to meet delivery requirements for non-emergent requests submitted by the government. 4. Government Responsibilities: 4.1.1. A Contracting Officer Representative (COR) will be designated, and is responsible for local contract administration issues such as ordering and providing specific delivery instructions. A letter of delegation that outlines the COR s specific responsibilities will be provided to the contractor at the time of contract award. 4.1.2. The government ensures proper and timely submission of orders to allow Contractor to meet required delivery date will provide a list to the Contractor of approved individuals who have authority to place orders against the awarded contract. 4.1.4. The government will provide a list of approved individuals who have the authority to receive and sign for the goods being delivered. 5. Contractor Performance Requirements and Responsibilities: The Medical-grade oxygen classified as a drug and must meet USP specifications. Bulk oxygen tanks are classified as a drug delivery device, and all contractors shall be registered with the Food and Drug Administration. The quantities are estimates of the facility s annual requirements. There is no express or implied guarantee that these quantities will be purchased. The base contract period shall be 01 April 2018 31 March 2019 or date of award. Please note that contracts that include the installation of contractor owned equipment shall include a 60-day transition period at the beginning and end of the contract period. The contract awarded shall include four (4) one-year option periods. Prior to first filling, contractor shall perform in-service training for facility personnel, such as the COR and any other personnel deemed appropriate by the Contracting Officer, to include the following facets for contractor owned and government owned systems: the refill procedure, and preventative maintenance support requirements that may be needed from the medical center systems, and an explanation of all the volume alarm and low pressure set-points. The contractor shall provide written procedures and training for VA staff protocols to accomplish emergency shutdowns or other sudden, unplanned termination of the refilling process. Contractor shall provide 24/7 emergency contact name(s) and telephone number(s). Prior to first filling, and annually thereafter, alarm set-point testing and written verification shall be presented through the use of a qualified third party expert per NFPA 99, 2018 Edition (http://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=99) for contractor owned and government owned systems. Any code deficiencies in the Medical Center s existing system, as defined by NFPA 50, 2001 Edition (http://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=50), 1.3.3, Bulk Oxygen System , shall be identified by the contractor. A detailed explanation of these deficiencies shall be presented in writing to the COR. Receipt of this written explanation shall be signed for by the COR. Prior to first filling, and annually thereafter, the contractor shall verify, in writing, the accuracy of all gauges on contractor owned tanks. If the gauge(s) are government owned, contractor shall provide, if requested after award, a written proposal with price to verify accuracy of the gauge(s). The Government may choose to exercise this option at its desire. Prospective Offerors are strongly encouraged to visit the bulk oxygen tank site at the facility prior to submitting an offer. The site visit will be scheduled with the Contract Specialist. Contractor shall provide for the following as outlined below: Bulk Oxygen Delivery weekly on Friday for the Downtown facility. Quantities are listed per 100 cubic feet. Actual quantity requested for the period identified is an estimated 120,000 cubic feet. Bulk Oxygen - Delivery monthly on Friday for the Uptown facility. Quantities are listed per 100 cubic feet. Actual quantity requested for the period identified is an estimated 6,000 cubic feet. Emergency Delivery Fee Two per division (2 Downtown and 2 Uptown) for the 12-month contract period. Bulk Oxygen monthly portable tank rental. Telemetry monthly rental for both tanks 1 each for both uptown and downtown in order that vendor may have constant awareness of levels in tanks at all times. 5.1.8. Contractor shall refer to delivery schedule (provided after award) which specifies order submission and delivery dates, to include alternate dates as a result of observed federal holidays. 6. Delivery of Medical Liquid Bulk Oxygen: Bulk Oxygen is ordered by and delivered to the individual ordering facility. Specific information regarding any unique delivery requirements is included in the solicitation Price Schedule. The contractor shall deliver medical-grade liquid oxygen within the time-frame specified in the schedule. The time-frame identified may be either the number of calendar days after receipt of the Government s order, the specific days of the week for delivery, the specific time intervals between deliveries, a specified reorder point, or other specified ordering and delivery methods. Upon award, delivery time-frame shall be discussed with site COR listed in the schedule, as sites shall have the option to establish an automatic delivery schedule. If the time frame for contractor delivery is not identified in the facility requirements, the contractor shall provide 24-hour notice prior to delivery or upon mutual agreement between the facility and contractor, alternate ordering/delivery methods such as pre-scheduled deliveries, calling for tank level readings, installing a telemetry unit, etc. may be arranged. If for any reason the contractor is unable to delivery at the agreed upon day or time, the contractor shall provide 24-hour notice to the COR, so that the facility can initiate an alternate backup action. In accordance with VHA Patient Safety Alert dated April 5, 2004. (https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1279) and VHA Directive 2005-028 (https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1279) dated June 24, 2005 all deliveries shall be monitored by a qualified and trained technical representative that will be designated by each facility. Contractor shall be provided with names and contact information of primary and back-up facility representatives. This applies to all deliveries regardless of time or day of execution. Tanks(s) shall be filled to maximum functional capacity at each refilling procedure unless otherwise specified in the facility requirements or as agreed upon in a written document signed and dated by the COR. At the time of each delivery, contractor shall provide a legible signed and dated written document that identifies the tank level prior to fill, the level after fill, and the quantity delivered. This document must be counter-signed by the facility representative supervising the delivery. Emergency delivery shall be provided within 24 hours after receipt of Government notification. Contractor shall respond to the facility by either telephone or email within one hour to confirm receipt of emergency notification to ascertain the nature of the emergency. Emergency status is determined by the Government when conditions warrant, such as an actuated main bulk tank low level alarm, imminent alarm condition, or system leak. Failure of the contractor to remain current with agreed delivery schedule and requirements does not constitute an emergency for purposes of charging an emergency delivery fee. 7. Quality Assurance Specifications and Requirements: Performance Indicators PWS Ref Performance Measure Acceptable Level of Quality Method of Assessment Incentive Regular weekly delivery of bulk oxygen Para 5.1.7, 6.1.1, & 6.2 Within time frame developed by COR and Vendor. 95% Visual Inspection/Observation and random inspection. Exercise option/contract renewal Respond to emergency calls within two hours. Para 5.1.7, 6.1.5. Within time frame developed by COR and Vendor. 95% Visual Inspection/Observation and random inspection. Exercise option/contract renewal Tank Rentals Para 5.1.7. & 6.1.3. Within time frame developed by COR and Vendor. 95% Visual Inspection/Observation and random inspection. Exercise option/contract renewal All medical gas manufacturers and fillers of medical gases shall be registered with FDA as drug manufacturers. All oxygen shall be manufactured, processed, packed, transported, and stored according to FDA s Current Good Manufacturing Practices (CGMP) regulations, and all labeling shall comply with FDA s labeling regulations (21 CFR Part 201 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201). Liquid bulk oxygen delivered under the contract shall be medical-grade and shall meet or exceed the standards cited in the current edition of the United States Pharmacopoeia/National Formulary (U.S.P.). A valid certificate of analysis shall be provided with each delivery of liquid oxygen. The certificate shall include, at a minimum: Supplier s name and complete address Name of the Product (i.e. Oxygen U.S.P.) An Air Liquefaction Statement where appropriate Lot number or other unique identification number Actual analytical results for full U.S.P. monograph testing. (A statement that only states that the product meets the minimum purity of 99.5%, etc. is not acceptable.) Test method used to perform the analysis. (A statement such as Meets U.S.P. specifications is not acceptable; nor would Tested via Servomex be acceptable since the specific model number is not provided.) Signature of authorized supplier representative and date. Material Safety Data Sheets shall be provided to the facility upon request. A copy of all inspection reports shall be provided to the facility COR upon the completion of any contractor owned or government owned bulk oxygen system inspections that are required by regulation. All contractor-owned equipment shall be maintained or repaired in accordance with NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites, 2001 and FDA s Current Good Manufacturing Practices (CGMP) Regulations (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm). 8. Contractor-Owned Equipment: 8.1.1. The facilities listed in the schedule as having contractor owned tanks, the contractor shall provide, install and maintain bulk oxygen tank(s) with appropriate back-up system(s). Through the duration of the contract, the contractor shall be liable for the integrity, suitability, and safety of contractor owned tank(s) that shall insure compliance with applicable regulations, standards and normal good practices. The tank capacity and reserve system shown in the schedule are minimum capacities required by the using facilities. Manifold, cylinders for the reserve supply, liquid converter, alarm switch, regulator, valves, level indicator, and any other devices or connections required for proper tie-ins with the facility s gas system shall be furnished by the contractor, without cost to the Government. The manifold or liquid converter shall deliver gas at a pressure and rate of flow adequate to supply the system. Each liquid oxygen storage container shall have an outlet that allows access for testing the purity of the oxygen. 8.1.2. All equipment and materials required to perform on the contract (other than what is specifically listed in paragraph 10, Government-Furnished Property) shall be provided by the contractor. Contractor owned equipment shall be installed, inspected and maintained by the contractor without additional cost to the Government. (i.e., all installation, inspection and maintenance costs shall be included in the contract s monthly equipment rental fee for the applicable facility.) Contractor owned equipment shall be kept in good operating condition and appearance, in accordance with applicable regulations, standards and normal good practices. The contractor shall be provided reasonable access to the bulk oxygen systems for this purpose. 9. Installation of Contractor-Owned Equipment: 9.1.1. Unless otherwise directed by the using facility, contractor owned equipment shall be installed by the first day of the period of performance (directed by Contracting Officer) and shall be connected to the medical gas system on that date; provided that the contractor shall be allowed a maximum of sixty calendar days after receipt of notice of award to complete installation. If the contractor s equipment replaces equipment already in use, the exchange of equipment shall be accomplished without interruption of gas supply to the using facility. Contractor installed equipment shall remain the property of the contractor and shall be removed upon termination of the contract when directed by the ordering facility and in full cooperation with the succeeding contractor so as to avoid interruption of gas supply. 9.1.2. No guarantee is given or implied that data included in the schedule regarding contractor owned equipment currently located at the facilities is complete and accurate as to the factors affecting the cost of furnishing and installing the required contractor owned tanks and appurtenances. Offerors are strongly encouraged to visit the facility sites prior to submitting an offer and take other steps as may be reasonably necessary to ascertain the nature and location of the work, and the general and local conditions which can affect the work or the cost thereof. Failure to do so shall not relieve offerors from the responsibility of estimating properly the difficulty and cost of successfully performing the work. Site visits may be arranged by contacting in the solicitation schedule. 10. Government-Owned Cylinders 10.1.1. Individual Agency Ownership of Cylinders: Government owned cylinders shall remain the property of the individual ordering (owning) agency and shall not be exchanged for other cylinders, either government-owned or contractor-owned, without authorization of the Contracting Officer Representative (COR) at the ordering agency. 11. Invoicing: 11.1.1. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor, validated by the Contracting Officer s Representative (COR), and submitted electronically through OB-10 (https://portal.tungsten-network.com/). 11.1.2. A properly prepared invoice shall contain: Invoice Number and Date services were provided Contractor s Name and Address Accurate Purchase Order Number Description of Supply or Service provided Total amount due 12. Special Contract Requirements PER REVIEW OF VA HANDBOOK 6500.6, CONTRACT SECURITY, APPENDIX A- INFORMATION SECURITY AND PRIVACY CHECKLIST: The C&A requirements do not apply and a Security Accreditation Package is not required. Acquisition of this service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information to the vendor There may exist exposure to VA sensitive information, in particular to sensitive personal information (SPI) while implementing contractual services Minimum Statutory Requirements Prohibition on unauthorized disclosure: Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). See VA Handbook 6500.6, Appendix C, paragraph 3.a. Requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COTR, the designated ISO, and Privacy Officer for the contract. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a Requirement to pay liquidated damages in the event of a data breach: Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs (see VA handbook 6500.6, appendix c, paragraph 7.a, 7.d) Prior Contract Number: 36C24719C0019
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