6515--OsmoPRO MAX Automated Osmometer

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STATEMENT OF WORK (SOW) GENERAL INFORMATION Title of Project: Acquisition of one Automated Osmometer System for Pathology and Laboratory Medicine Service. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. The contractor shall provide all resources necessary to furnish, deliver, install, validate, and train Government personnel on one fully automated osmometer system for the Birmingham VA Health Care System (BVAHCS), Pathology and Laboratory Medicine Service. Birmingham VA Health Care System Room 3427 700 South 19th Street Birmingham, AL 35233The requested equipment will replace an outdated end-of-life osmometer system that is no longer eligible for manufacturer parts, repair, or service support. The contractor shall provide all required accessories, consumables, installation, validation support, warranty documentation, and technical support necessary for full operational capability. The equipment provided shall meet or exceed all Government-required salient characteristics.
Background: The Birmingham VA Health Care System currently utilizes an osmometer that has reached end-of-life status and is no longer supported by the manufacturer for parts, repairs, or service. Replacement of the existing system is required to maintain laboratory diagnostic testing capability within the Pathology and Laboratory Medicine Service. The requested automated osmometer system will improve operational efficiency through automation features including barcode scanning, reduced manual pipetting, direct primary tube sampling capability, continuous loading capability, and laboratory information system (LIS) interface capability.
Period of Performance: Delivery, installation, validation, and training shall be completed within sixty (60) calendar days after receipt of award (ARO). Scheduling shall be coordinated between the contractor and Birmingham VA Health Care System. Specific performance dates beyond the required completion window are not applicable to this equipment procurement. Work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).
Type of Contract: Firm-Fixed-Price
GENERAL REQUIREMENTS
For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, and along with associated sub-milestone dates. The contractor's subtask structure shall be reflected in the technical proposal and detailed work plan. All written deliverables shall be phrased in clear and concise language. Statistical and other technical terminology shall not be used without providing a glossary of terms. Where a written milestone deliverable is required in draft form, the VA will complete their review of the draft deliverable within _5_ calendar days from the date of receipt. The contractor shall have _5_ calendar days to deliver the final deliverable from date of receipt of the Government s comments. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in Section A.4 of this SOW.
Task One: The contractor shall provide one (1) fully automated osmometer system with all necessary accessories and components required for operation.
Deliverable One: One fully operational automated osmometer system, required accessories and operational components, and Initial consumables required for implementation
Task Two: The contractor shall provide on-site installation, setup, operational validation support, and user training for Birmingham VA Health Care System laboratory personnel.
Deliverable Two: Installation and setup documentation, Validation support documentation, and Training completion documentation
Task Three: The contractor shall provide warranty documentation, manufacturer documentation, and technical support information.
Deliverable Three: Manufacturer warranty documentation, technical support contact information, and User manuals and manufacturer documentation SCHEDULE FOR DELIVERABLES The contractor shall complete delivery, installation, validation, and training within sixty (60) calendar days after receipt of award.
Unless otherwise specified, all documentation shall be provided electronically.
If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor shall notify the Contracting Officer in writing, provide the reason for the delay, and identify the anticipated completion date.
This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response, in accordance with applicable regulations.
CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. REPORTING REQUIREMENTS Formal monthly progress reports are not required for this equipment procurement requirement. The contractor shall communicate installation scheduling, delivery status, and any performance issues directly with the Contracting Officer and designated Government point of contact as needed.
TRAVEL [If applicable] Travel associated with delivery, installation, validation, and training shall be included in the contractor s quoted price. GOVERNMENT RESPONSIBILITIES [If applicable] The Government shall provide reasonable access to the installation site, utilities, and appropriate workspace necessary for equipment installation and validation activities. The Government shall coordinate scheduling with contractor personnel and provide access to designated laboratory personnel for operational training. The Government will inspect the equipment upon delivery and installation to verify compliance with the requirements and salient characteristics identified in this Statement of Work. Final acceptance will occur after successful installation, operational verification, and completion of training.

CONTRACTOR EXPERIENCE REQUIREMENTS (Standard mandatory language for all task orders) The government will determine on a stated requirements (SR) basis what positions are considered key personnel. The contractor shall identify, by name, the key management and technical personnel who will work under this task order at the time the work is being negotiated.
If a key person becomes unavailable to complete the SR, the proposed Substitutions of key personnel shall be made only as approved directed by the Contracting Officer and the COR. The government will not dictate specific experience and education requirements of the employees initially proposed to perform the work stated herein. The contractor shall submit a resume of qualifications for the COR and all other direct employees proposed for the project. All Contractor employees will be approved by the COR prior to bringing on duty. If, at any time from date of award to the end of the contract, non-key personnel Contractor personnel are no longer available, HES/HIS reserves the right to review the qualifications of the proposed replacement personnel and to reject individuals who do not meet the qualifications set forth in the TLO. Team personnel proposed by the contractor should possess some of the following knowledge and/or skills: The contractor must notify VHA in advance and we will approve or reject proposed contractor key personnel for the performance of this contract. The contractor shall submit a resume of qualifications to the COR for key personnel and all other direct employees proposed for the project. All Contractor employees will be approved by the COR prior to bringing on duty. If, at any time from date of award to the end of the contract, Contractor personnel are no longer available, the VHA will approve the qualifications of proposed replacement personnel and will reject individuals who do not meet qualifications set forth herein. The contractor must inform the VHA COR and Project Manager/Task Manager when personnel are removed from the contract for any reason. The Contractor shall remove any employee from the performance of this contract within five (5) workdays of receiving notice from the Contracting Officer that the employee's performance is unsatisfactory. All Contractor employees are subject to immediate removal from performance of this contract when they are involved in a violation of the law, VA security, confidentiality requirements and/or other disciplinary reasons. The contractor must inform the VHA COR and Project Manager/Task Manager when personnel are removed from the contract for any reason. If a key person becomes unavailable to complete the SR, proposed Substitutions of key personnel shall be made only if approved by the COR and Project Manager. The contractor shall submit a resume of qualifications to the COR for all direct employees proposed for the project. All Contractor employees will be approved by the COR prior to bringing on duty. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS1 11.1 All contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access. Position Sensitivity The position sensitivity has been designated as ____________________ (Insert High Risk, Moderate Risk or Low Risk.) Background Investigation The level of background investigation commensurate with the required level of access is ____________ (Insert Background Investigation, Minimum Background Investigation or National Agency Check with Written Inquiries). Contractor Responsibilities The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship, and are able to read, write, speak and understand the English language. The contractor shall submit or have their employees submit the required forms (SF 86 or SF 85P, SF 85P-S, FD 258, Contractor Fingerprint Chart, VA Form. 0710, Authority for Release of Information Form, and Optional Forms 306 and 612) to the VA Office of Security and Law Enforcement within 30 days of receipt. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the affected employee from working under the contract. Failure to comply with contractor personnel security requirements may result in termination of the contract for default. If contractor will have access to VA Network, provide software upgrades or other VA sharing or disclosure of PHI or PII is given the contractor please include this statement: Contractor will be required to enter into a Business Associate Agreement (BAA) upon award of the contract, or a copy of national BAA is attached with this paperwork. (See VHA HIA BAA template) Not Required. [If the above (e.) applies then include this statement:] Contractor will be required to create an account in the Talent Management System (TMS) and take the Privacy & HIPAA training course #10203 before being given access and annually thereafter. 11.3 Government Responsibilities The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor, or to the contractor s employees, after receiving a list of names and addresses. Upon receipt, the VA Office of Security and Law Enforcement will review completed forms for accuracy and forward the forms to the office of Personnel Management (OPM) to conduct background investigations. The VA Office of Security and Law Enforcement will notify the CO, and contractor, of adjudication results received from OMB. Upon being notified about a favorable determination, the CO may issue a notice to proceed to the contractor. PROCEDURES FOR ACCESS: Access requirements to VA information systems by contractors and contractor personnel shall meet or exceed those requirements established for personnel as described in VHA directives. A written and signed request for user access by VHA management, or designee(s), constitutes management approval (sponsorship) to initiate a request for access to any sensitive automated information system. Access shall be granted to non-VA users only if the purpose for access meets criteria of the Privacy Act and VA Confidentiality Regulations and Transfer. Contractors personnel shall be required to sign in before starting work under this contract and abide by the VA Computer Access Security Agreement and Confidentiality Agreement. In the performance of official duties, the contractor's personnel may regular access to printed and electronic files containing sensitive information, which must be protected under the provisions of the Privacy Act of 1974, HIPAA and other applicable Federal laws and regulations. The employee is responsible for (1) protecting that information from unauthorized release or from loss, alternation or unauthorized deletion, and (2) following applicable regulations and instructions regarding access to computerized files, release of access codes, etc. as set out in a computer access agreement which the employee signs.
SALIENT CHARACTERSITICS: The proposed automated osmometer system shall: Utilize freezing point depression methodology Support direct sampling from primary tubes Include barcode scanning capability Reduce or eliminate manual pipetting requirements Support laboratory information system (LIS) interface capability Support quality control data management functionality Support continuous sample loading capability Include automated sample identification and traceability functionality Include on-site installation and setup Include operational and performance validation support Include on-site user training for laboratory personnel Include manufacturer warranty documentation Include technical support contact information Include a minimum one-year manufacturer warranty covering workmanship and parts