Q201--TPN Prep and Delivery VAPS
THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AN... THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325412 (size standard of 1250 Employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Salient Characteristics and Statement of Work Background Information Total parenteral nutrition (TPN) is a way of supplying all the nutritional needs of the body by bypassing the digestive system and dripping nutrient solution directly into a vein. Parenteral nutrition (PN) solution is a sterile intravenous solution of protein, dextrose and fat in combination with electrolytes, vitamins, trace elements and water. The contents of the TPN solution are determined based on the age, weight, height, and the medical condition of the individual. Successful TPN requires frequent monitoring of the individual's weight, glucose (blood sugar) level, blood count, blood gasses, fluid balance, urine output, waste products in the blood (plasma urea) and electrolytes. Liver and kidney function tests may also be performed. The contents of the solution are individualized based on the results of these tests. All solutions contain sugar (dextrose) for energy and protein (amino acids). Fats (lipids) may also be added to the solution. Electrolytes such as potassium, sodium, calcium, magnesium, chloride, and phosphate are also included, as these are essential to the normal functioning of the body. Trace elements such as zinc, copper, manganese and chromium are also needed. Vitamins can be included in the TPN solution, and insulin, a hormone that helps the body use sugar, may need to be added. TPN is most frequently administered in a hospital, but under certain conditions and with proper patient and caregiver education, it is used at home for long-term therapy It is estimated that one or more veterans may require contract services (preparation of TPN solutions and product home delivery) as stated herein at any one time. The number of veterans will fluctuate during the term of the contract due to program enrollment. Some Veterans may remain with the program for the entire period of the contract and others only for a portion of such time. All invoices will be submitted monthly in arrears of services performed. Invoices should be combined for each patient per month: one invoice per patient per month. The Puget Sound HCS will provide all IV pumps, IV catheter care supplies, etc. The Puget Sound HCS will be responsible for training and education of the patient or caregiver on administering the TPN and PICC line care. The contractor has no responsibility for providing any training. Contract Requirements This contact request is for the preparation and delivery of TPN solution to the Veteran patients homes for home-based long-term Hyperalimentation (TPN) therapy. The patient s VA physician establishes the plan of treatment in consultation with the VA Puget Sound PIVOT (Program for I.V. Outpatient Therapy) pharmacist. The plan of treatment includes information on diagnoses, treatment including procedures and medications and precautions and limitations that affect the plan of care. The Contractor shall refer all medical and procedural questions asked by the patient to the VA Puget Sound PIVOT pharmacist. The VA Using Service will place the initial order for a new patient and will generally reorder the hyperalimentation weekly until patient is stable. Once patient is stable the reordering can be every two (2) weeks. If any adjustments in delivery time or date are needed, the Veteran patient will contact the Contractor directly. Multivitamins and other additives may be required. The Contractor is responsible for assessing the patient(s) inventory of hyperalimentation on a weekly (for new patients) or a two (2) week cycle basis, and balance the patient(s) inventory of hyperalimentation through single or multiple item shipments, as required. Preparation: Based on the treatment plan and direction from the VA physician and the PIVOT pharmacist, the contractor will prepare or oversee the preparation of the individualized formula to meet the nutritional needs of the patient. The TPN solution is mixed in a sterile environment and is packaged to maintain sterility. It comes mixed in a bag to be administered via IV. In the standard formula, carbohydrates provide most of the calories. Typically, about 4 to 5 mg/kg/min of dextrose is given. Standard solutions contain up to about 25% dextrose, but the amount and concentration depend on other factors, such as metabolic needs and the proportion of caloric needs that are supplied by lipids. Commercially available lipid emulsions are often added to supply essential fatty acids and triglycerides Formulas may also contain water, protein, fats, vitamins, and minerals. Essential amino acids (components of protein) and essential fatty acids (components of fat) are also included Basic TPN solutions are prepared using sterile techniques, usually in liter batches according to standard formulas. Solutions may be modified based on laboratory results, underlying disorders, or other factors. The contractor must be able to prepare/provide the solutions as directed. Normally, 2 L/day of the standard solution is needed. Delivery of TPN Solution to Patient The Contractor will provide direct delivery of the TPN solution to the patient to allow him/her to remain at home. Direct deliveries will be FOB Destination at the residence of the Veteran(s) located primarily in the State of Washington as specified at the time of the order. This does not preclude delivery to a skilled nursing facility if the Veteran is residing in a skilled nursing facility. The contractor is responsible for the appropriate temperature controls and other care of the product(s) during delivery and assuring patient actually receives the product (i.e., product is not left on porch). New prescriptions and prescription changes for patient(s) will be shipped to the patient(s) residence within twenty-four (24) hours. The time starts once the order is placed and the PIVOT Pharmacist notifies the contractor. Confirmation must be received from the contractor to the PIVOT Pharmacist once the order is placed. In the event of a national, regional or local emergency it is important that the Contractor can ensure that the patient will always have at least a 24-hour supply of the prescribed TPN solution on hand. The Contractor must provide the VA a copy of its Emergency Preparedness Plan to ensure continued service to hyperalimentation patients. Contract Administration: The Contractor must have a recognized accreditation such as Joint Commission Accreditation or Accreditation Commission for Health Care (ACHC). The C&A requirements do not apply and a Security Accreditation Package is not required. Invoices shall be submitted monthly in arrears of services performed, no later than 15 days following month of service, for payment to the VA and shall reference the name, address and social security number of the Veteran. Hyperalimentation products shipped to Veteran patient shall be itemized as listed on the contract for all deliveries made during the month of invoice under the terms of this contract and shall be for the full cost of such services. Do not combine two different months on the same invoice and submit only one invoice per patient per month, with products itemized by date provided. All product recalls, accidents, malfunctions, injuries and deaths related to the provision, delivery and use of Contractor-provided products and supplies will be immediately reported to the COR, the PIVOT pharmacist and to the product/supplies manufacturer. Privacy Officer Language for Statement of Work 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). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. Records Management Language 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. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.
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