Inactive

Sources Sought Notice This is not a request for formal proposals or quotes, it does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses ... Sources Sought Notice This is not a request for formal proposals or quotes, it does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potentially qualified businesses interested in and capable of providing the required services. Documentation of technical expertise must be presented in sufficient detail for the government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone and email (e) UEI number (f) Cage Code (g) Type of small business, e.g., Services Disabled Veteran Owned Small Business, Veteran-Owned Small Business, 8(a), HUBZone, Women Owned Small Business, Small Disadvantaged Business, Small Business, or Large Business; and (h) Capability statement that addresses the organization s qualifications and ability to perform as a contractor for the work described below. This Sources Sought is for the VISN 15 VA Medical Centers who have a requirement for Compounding Services (see Attached Statement of Work, Common Supplies and Intravenous Therapy Agents List 2025 for details). Inpatient Pharmacy Address VISN 15 589 Kansas City, MO 4801 E. Linwood Blvd. Kansas City, MO 64128 VISN 15 589A4 Columbia, MO 800 Hospital Drive Columbia, MO 65201 VISN 15 589A5 Topeka, KS 2200 SW Gage Blvd. Topeka, KS 66622 VISN 15 589A6 Leavenworth, KS 4101 4th St. Trafficway Leavenworth, KS 66048 VISN 15 589A7 Wichita, KS 5500 E. Kellogg Drive Wichita, KS 67218 VISN 15 657 St. Louis, MO J. Cochran 915 N. Grand Blvd. St. Louis, MO 63106 VISN 15 657A0 St. Louis, MO J. Barracks 1 Jefferson Barracks Dr. St. Louis, MO 63125 VISN 15 657A4 Poplar Bluff, MO 1500 N. Westwood Blvd. Poplar Bluff, MO 63901 VISN 15 657GH Cape Girardeau, MO 711 S. Mount Auburn Rd. Cape Girardeau, MO 63701 VISN 15 657A5 Marion, IL 2401 West Main Street Marion, IL 62959 VISN 15 657GJ Evansville IN 6211 East Waterford Blvd. Evansville, IN 47715 The NAICS Code is 424210 with a Small Business size standard of 250 Employees. SDVOSB/VOSB vendors must be registered in the SBA VetCert database. Offerors capable of providing this service shall notify the Contract Specialist no later than (NLT) October 31, 2025, 1:00 pm CST via email at maria.owen2@va.gov All information is to be submitted via email to: maria.owen2@va.gov. Phone calls will not be accepted. STATEMENT OF WORK VISN 15 Hazardous and Non-Hazardous Pharmacy Compounded Sterile Preparation Contingency REQUIREMENT: The VA Heartland Health Care Network (VISN15) VAMC facilities listed below require compounding hazardous and nonhazardous sterile compounded intravenous products. These compounding services are necessary to provide intravenous therapy treatments to Veterans diagnosed with specific medical conditions. Compounding must be done at an FDA 503A complaint facility and meet all state and federal laws. This contract would be utilized primarily as a contingency plan in the event of downtime of sterile compounding areas and will improve resiliency of supply. The government anticipates awarding Firm-Fixed Price Blanket Purchase Agreements (BPA) for this requirement. There is no minimum price required. BACKGROUND: VHA compounding practice is governed by 1108.12, Management and Monitoring of Pharmaceutical Compounded Preparation. Within this document it is noted that VA pharmacy compounding practice must adhere to the standards under USP <797>, <800>, and <795> including the requirement that certification must occur, CETA standards must be followed, and delivery standards must be met. Correspondingly, after the 2012 national fungal outbreak, Congress established a new federal law under the Drug Quality and Safety Act (DQSA) that designates specific operational requirements to compound medications. VA facilities are categorized as 503A compounding pharmacy, and as such must comply with 21 U.S. Code § 353a - Pharmacy compounding. VISN 15 facilities are in the process of or are planning on upgrading/constructing compounding spaces to continuously meet standards mentioned above. When available, VISN 15 facilities utilize other VHA resources. When other VHA resources are unavailable, As such, VISN 15 requires an IDIQ Requirements contingency contract to provide hazardous and non-hazardous compounded intravenous products during planned or unplanned downtime of VA pharmacies sterile compounding areas for upgrades, construction or other reasons. PERIOD OF PERFORMANCE This procurement is for five (5) year ordering period, period of performance from 03/01/2025 02/28/31. PLACES OF PERFORMANCE Facility Name Address VISN 15 589 Kansas City, MO 4801 E. Linwood Blvd. Kansas City, MO 64128 VISN 15 589A4 Columbia, MO 800 Hospital Drive Columbia, MO 65201 VISN 15 589A5 Topeka, KS 2200 SW Gage Blvd. Topeka, KS 66622 VISN 15 589A6 Leavenworth, KS 4101 4th St. Trafficway Leavenworth, KS 66048 VISN 15 589A7 Wichita, KS 5500 E. Kellogg Drive Wichita, KS 67218 VISN 15 657 St. Louis, MO J. Cochran 915 N. Grand Blvd. St. Louis, MO 63106 VISN 15 657A0 St. Louis, MO J. Barracks 1 Jefferson Barracks Dr. St. Louis, MO 63125 VISN 15 657A4 Poplar Bluff, MO 1500 N. Westwood Blvd. Poplar Bluff, MO 63901 VISN 15 657GH Cape Girardeau, MO 711 S. Mount Auburn Rd. Cape Girardeau, MO 63701 VISN 15 657A5 Marion, IL 2401 West Main Street Marion, IL 62959 VISN 15 657GJ Evansville IN 6211 East Waterford Blvd. Evansville, IN 47715 PERFORMANCE REQUIREMENTS The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contingency IDIQ Requirements contract for all medications, diluents, fluids, IV Tubing, closed system drug transfer devices and any other compounding and administration supplies items deemed necessary for the provision of hazardous and non-hazardous compounded intravenous products. All sterile products will be aseptically compounded based on patient specific orders, in accordance with federal, state and local laws and any regulatory or accrediting bodies. Additionally, the vendor shall provide all deliveries and handling of materials and supplies to ensure appropriate storage conditions are maintained during shipment, to include segregated shipment and labeling for hazardous versus non-hazardous sterile compounds. PRESCRIPTION ORDERS: Orders will be submitted via secure network or fax. Once submitted, VA staff will confirm receipt of order with vendor by phone or email. Each prescription will include the following: Patient name Patient address (with first order for each patient) Patient phone number (with first order for each patient) Gender Date of birth Height Weight Allergies Drug dosage Diluent and volume Rate Administration/procedure date Prescribing physician/signature DELIVERY Orders submitted by the facilities by 2:00pm CST will be delivered by the vendor by 9:00am CST the following day. The vendor will ensure appropriate storage conditions are maintained during shipment for all materials and supplies. Compounded orders shall be transported via Courier, overnight mail service, or any other means necessary to ensure receipt prior to infusion date/time to the following locations. Inpatient Pharmacy Room # Address VISN 15 589 Kansas City, MO V2-710 4801 E. Linwood Blvd. Kansas City, MO 64128 VISN 15 589A4 Columbia, MO E001 800 Hospital Drive Columbia, MO 65201 VISN 15 589A5 Topeka, KS 1- A10 2200 SW Gage Blvd. Topeka, KS 66622 VISN 15 589A6 Leavenworth, KS B237 4101 4th St. Trafficway Leavenworth, KS 66048 VISN 15 589A7 Wichita, KS 101-3 5500 E. Kellogg Drive Wichita, KS 67218 VISN 15 657 St. Louis, MO J. Cochran Bldg 1, 4th Floor B405 915 N. Grand Blvd. St. Louis, MO 63106 VISN 15 657A0 St. Louis, MO J. Barracks JB 55 1st Floor,1c100 1 Jefferson Barracks Dr. St. Louis, MO 63125 VISN 15 657A4 Poplar Bluff, MO Bldg 1 Ground Floor, GB-007 1500 N. Westwood Blvd. Poplar Bluff, MO 63901 VISN 15 657GH Cape Girardeau, MO Rm 1106 711 S. Mount Auburn Rd. Cape Girardeau, MO 63701 VISN 15 657A5 Marion, IL Rm D109 2401 West Main Street Marion, IL 62959 VISN 15 657GJ Evansville IN Rm 1110.1 6211 East Waterford Blvd. Evansville, IN 47715 TECHNICAL INDUSTRY STANDARDS The Contractor shall conform to the standards established by: US Pharmacopeia (USP) as to USP 797, USP 800 The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement. Proof may also be furnished by the organization listed above certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards. Offerors may obtain the standards cited in this provision by submitting a request, including the solicitation number, title and number of the publication to: US Pharmacopeia (USP) selma.mitiche@usp.org The offeror shall contact the Contracting Officer if response is not received within two weeks of the request. 6. DESCRIPTION OF WORK The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contingency IDIQ Requirements contract for all medications, diluents, fluids, IV Tubing, closed system drug transfer devices and any other compounding and administration supplies items deemed necessary for the provision of hazardous and non-hazardous compounded intravenous products. All sterile products will be aseptically compounded based on patient specific orders, in accordance with federal, state and local laws and any regulatory or accrediting bodies, to include VA PBM evaluation of Outsourced 503B Compounding Pharmacy regulatory requirements and all required documents. The vendor will prevent risk of contamination, ensuring the safety and efficacy of compounded medications provided to Veterans. Additionally, the vendor shall provide all deliveries and handling of materials and supplies to ensure appropriate storage conditions are maintained during shipment. This contingency contract will allow VISN 15 pharmacies to continue to deliver essential compounded medications to patients without interruptions in the event of planned or unplanned downtime of VA pharmacies sterile compounding areas and when other VHA resources are unavailable. 7. DELIVERABLES The contractor shall furnish all necessary materials, supplies, equipment, and personnel to complete required tasks. CONTRACTOR FURNISHED MATERIALS. Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800, Drug Supply Chain Security Act (DSCSA) and federal law. All drugs and supplies are to be supplied by the Contractor. See attachment Common Supplies and Intravenous therapy Agents List. This list is not inclusive, and agents may be added or deleted as the mission needs change. Contractor shall invoice for billable units for the amount of medication utilized for each individual patient. Contractor shall follow USP 800 delivery standards for hazardous medications. Contractor shall provide USP 797 and USP 800 annual competencies of employees. Contractor shall provide current and past certification reports for the sterile compounding areas and compounding hoods. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected. All reports shall be submitted to facilities within 5 days of result/receipt. Reports will be submitted to V15CSPPharmacists@va.gov. Contractor shall provide monthly viability results. In the case of any failures, contractor shall provide action plans for corrections of deficiencies and testing results showing the failures have been corrected. All reports shall be submitted to facilities within 5 business days or result/receipt. Reports will be submitted to V15CSPPharmacists@va.gov. Shipping fees are included in the order and there is no additional cost for any items delivered for the weekend. All shipments for weekend delivery will be arranged as needed to ensure delivery can be successfully completed. b. GOVERNMENT FURNISHED MATERIALS AND SERVICES. The Government will provide a list of the common infusion medications to the contractor. See attachment Common Supplies and Intravenous Therapy Agents List. This list is not inclusive, and agents may be added or deleted as the mission needs change. The Government will include all patient information listed above with each order. The Government will submit all orders via secure network or fax. The Government will confirm receipt of order with vendor by phone or email. c. SPECIFICATIONS FOR COMPATIBILITY NEEDS: Bag Spike Rule: All chemotherapy, monoclonal antibody agents and protein kinase inhibitors. Primary IV Sets: BD Primary Set (REF 2426-0007) or interchangeable set. BD Low Sorbing Primary Set (REF 2260-0500) or interchangeable set. BD Lo Sorbing 1.2 micron Primary set (REF 10010453) or interchangeable set. BD Lo Sorbing 1.2 micron Primary set (REF 10010453) Secondary IV Set: BD Secondary Set (REF 10014881) or interchangeable set. In-line Filter: All necessary compounded materials per manufacturer recommendation. Filter Rules: Filter is required for Abatacept, Avelumab, Cabazitaxel, Cetuximab, Daratumumab, Durvalumab, Pembrolizumab, Ramucirumab, Siltuximab, and others as recommend by manufacturing guidelines. Special Priming: Prime tubing with non-hazardous base fluid prior to the addition of medication to the bag. Then transfer primed tubing to final bag prior to adding medications. Total Volume Calculations Overfills in IV Bags: Total volume included on the pharmacy label must include all additive volume, the base solution volume and overfill volume in the container (including the manufacturer s overfill of premixed base solution.) HD chemotherapies and monoclonal antibody agents will have volume adjusted to stated diluent volume (removing calculated overfill and volume of medication.) Close System Device: Equashield Pre-meds: None Other: Occasionally need fluoroucil 5-FU in WalkMed bags and in CADD Medication Cassette (REF 21-7002-24), Avanos C-series Homepumps (REF C270050, C100020, and C270020) interchangeable cassette and Routine 5-FU SMARTeZ Elastometric Pump (PMI Item# SE0002-100C, SE0005-270C, SE0002-270C). WORK HOURS Facility Name Work Hours VISN 15 589 Kansas City, MO Rm V2-710 is open to receive medications 24/7 VISN 15 589A4 Columbia, MO Rm E001 is open to receive medications 24/7 VISN 15 589A5 Topeka, KS Rm 1, Basement A10 is open to receive medications 24/7 VISN 15 589A6 Leavenworth, KS Bldg 89, Floor 2, B237 is open to receive medications 24/7 VISN 15 589A7 Wichita, KS Rm 101-3 is open to receive medications 24/7 VISN 15 657 St. Louis, MO J. Cochran Bldg 1, 4th Floor, Rm. B405 is open to receive medications 24/7 VISN 15 657A0 St. Louis, MO J. Barracks JB 55, 1st Floor, Rm 1c-100 is open to receive medications 24/7 (however, the building has restricted access after business hours) VISN 15 657A4 Poplar Bluff, MO Bldg 1, Ground Floor, Rm GB-007 is open to receive medications M-F 0800-1800 and Sat, Sun & holidays 0800-1630 VISN 15 657GH Cape Girardeau, MO Rm. 1106 is open to receive medications M-F 0730-1630 VISN 15 657A5 Marion, IL Bldg 42, Room D109 is open to receive medications 24/7 VISN 15 657GJ Evansville IN 1st Floor Pharmacy Room 1110.1 is open to receive medications M-F 0800-1630 CONTINGENCY PLANNING The Contractor shall have a contingency backup plan in the event that compounding facility is affected by any certification discrepancies, equipment malfunctions, natural disasters, or other matters affecting performance of the contract. Contingency locations must meet the same criteria as stated herein. VISN 15 facilities must be notified prior to dispensing any medications from contingency location, and daily until contingency is no longer required. COMPLIANCE WITH APPLICABLE LAWS AND REGULATIONS The contractor shall ensure that services and materials provided and delivered to the Government under this contract comply with USP 797, USP 800 and all other applicable laws, statutes, regulations and guidelines for manufacture and handling of hazardous and non-hazardous sterile compounding products. The contractor shall also ensure that all services provided under this contract comply with all Government mandated procedures, standards and requirements. QUALITY ASSURANCE SURVEILLANCE PROGRAM The Government will monitor the Contractor s performance under this contract with these performance objectives. Certificates and Assessments will be submitted to V15CSPPharmacists@va.gov. Task ID Indicator Standard Acceptable Quality Level Method of Surveillance General 1 Orders processed accurately Contractor shall ensure all orders are processed per prescription order 100% Labeling 2 Orders received prior to infusion date/time Contractor shall comply with all safety requirements 100% Validated receipt of order 3 Contractor maintains certifications required for compounding Contractor shall furnish copies of certificates and complete VHA PBM Assessment Annually 100% Validated receipt of certificates and/or assessment 8. SECURITY REQUIREMENTS INFORMATION SYSTEMS OFFICER, INFORMATION PROTECTION The contractor will not have access to VA desktops or laptop computers, nor will they have access to online resources belonging to the government while conducting services or providing products. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. PRIVACY OFFICER The contractor will have access to protected Patient Health Information (PHI), but it will not have the capability of accessing patient information during the services provided to the VA. Any questions from either party about the medication that will be compounded will use two patient identifiers to confirm the correct patient for that medication prior to any conversation taking place. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses are de-identified. 9. GENERAL ADMINISTRATION POINTS OF CONTACT (POCs). The vendor will contact the POC to schedule product delivery. Upon arrival, the vendor will contact the POC. Facility Name CSP POC E-Mail Address VISN 15 589 Kansas City, MO Christina.Mears@va.gov VISN 15 589A4 Columbia, MO Kellie.Ellyson@va.gov VISN 15 589A5 Topeka, KS Christopher.Kneidel@va.gov Erik.Leon@va.gov VISN 15 589A6 Leavenworth, KS Christopher.Kneidel@va.gov Morkisha.Dobard@va.gov VISN 15 589A7 Wichita, KS Clint.Owens@va.gov VISN 15 657 St. Louis, MO (J. Cochran and J. Barracks) Kara.Townsend@va.gov Margaret.Raisch@va.gov Jamie.Murphy@va.gov John.Callahan6@va.gov VISN 15 657A4 Poplar Bluff, MO Alicia.Heuiser@va.gov Kasey.Tubb@va.gov VISN 15 657GH Cape Girardeau, MO Vickie.Settle@va.gov Craig.Eaton@va.gov VISN 15 657A5 Marion, IL Lindsay.Oliveira@va.gov Shyannon.McFarland@va.gov VISN 15 657GJ Evansville IN Nick.Ratcliffe@va.gov John.Hays@va.gov CONTRACT ADMINISTRATION DATA. All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized, and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. NON-PERSONAL SERVICES. This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government. HOURS OF OPERATIONS. Business hours: Monday through Friday, 8:00 a.m. 4:30 p.m. National Holidays: The holidays observed by the Federal Government are: New Year s Day; Martin Luther King s Birthday; Presidents Day; Memorial Day; Juneteenth National Independence Day; Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving; Christmas; and Any other observed Federal holiday. CONTRACT PERFORMANCE MONITORING. The COR(s) and Subject Matter Experts (SMEs) may perform surveillance of services by any of the methods listed below: Observing actual performance Inspecting the services to determine whether the performance meets the performance standards Review of any other appropriate records When unacceptable performance occurs, the POC shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a POC to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s). If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government. Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government. viii. Training. All Contractor employees and subcontractor employees requiring access to VA information or VA information systems shall complete the following before being granted access to VA information and its systems: On an annual basis, successfully complete the VA Privacy and Information Security Awareness and VA Information Security Rules of Behavior training. On an annual basis, sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the VA Information Security Rules of Behavior for Organizational Users, relating to access to VA information and information systems. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access. The Contractor shall provide the Contracting Officer and/or the COR a copy of the training certificates and affirmation that VA Information Security Rules of Behavior for Organizational Users signed by each applicable employee have been completed and submitted within five (5) days of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and acknowledgement of the VA Information Security Rules of Behavior, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. xi. Subcontract flow down. The Contractor shall include the substance of this clause, including this paragraph (k), in subcontracts, third-party agreements, and BAAs, of any amount and in which subcontractor employees, third-party servicers/employees, and business associates will perform functions where they will have access to VA information (including VA sensitive information, i.e., sensitive personal information and protected health information), information systems, information technology (IT) or providing and accessing information technology-related contract services, support services, and related resources (see VAAR 802.101 definition of information technology-related contracts). 10. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.