Inactive

This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this is to gain knowledge of potential qualified sources and their size relative to NAICS 541990, Standa... This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this is to gain knowledge of potential qualified sources and their size relative to NAICS 541990, Standard Size $15 Million. Responses will be used by the Government to make appropriate acquisition decisions. Responses are not considered responses to any potential solicitation announcement. Scope of Work The Central Arkansas Veterans Healthcare System (CAVHS). The contractor shall provide accreditation services for Research and Development Service and the Institutional Review Board. These standards will be performance-based using objective criteria and measurable outcomes to evaluate whether a Human Research Protection Program effectively implements the standards. Response to this notice should include a capability statement, and three (3) customer references to which you have provided similar services. All interested firms shall provide the following information: company name, address, point of contact, phone number, email address, capability statement, contract number, DUNS number, and business size pursuant to the NAICS Code 541990, Standard Size $15 Million. Responses to this notice shall be e-mailed to Jacqueline.Simpson3@va.gov. Telephone responses will not be accepted. Responses must be received in writing no later than Friday, March 29, 2019 at 11am CST. This notice is to assist the VA in determining sources only. A solicitation is not currently available. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Responses are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. DRAFT STATEMENT OF WORK Accreditation Services OBJECTIVE: Central Arkansas Veterans Healthcare System (CAVHS), is requesting for a contractor to provide accreditation services for at the Central Arkansas Veterans Healthcare System (CAVHS) in Little Rock, Arkansas. The contractor shall establish a partner-focused working relationship with the CAVHS Research and Development Service and the Institutional Review Board. The Research and Development Service, at the CAVHS requires courteous, professional and trained personnel to adhere to all principles, procedures and standards of the accreditation process. These personnel will: establish a partner-focused working relationship with the CAVHS Research and Development Service and the Institutional Review Board. demonstrate improved performance, reliability and timely service throughout the life of this contract. maintain the highest level of service consistent with the CAVHS mission. provide convincing proof that CAVHS is receiving superior service at a fair and reasonable price. SCOPE OF WORK: Contractor s Scope of Services shall include but not be limited to the following: Provide standards for protecting participants in human research that are clear, specific, and applicable to research across the full range of settings (e.g., university-based biomedical, behavioral and social science research, independent review boards, hospitals, government agencies, and others). The standards will address any special concerns (e.g., the use of vulnerable populations or heightened risk to privacy and confidentiality) that may arise in each setting. The standards will identify outcome measures that the CAVHS can use to assess and demonstrate quality improvement over time. These standards will be performance-based using objective criteria and measurable outcomes to evaluate whether a Human Research Protection Program effectively implements the standards. The evaluation will result in a grade of pass or fail for each standard and, where appropriate, will also include commendations or recommendations for meeting the standards. The accreditation process will provide a clear, understandable pathway to accreditation, along with equally clear pathways for appeal and the remediation of identified shortcomings. The accreditation process will be educational involving collegial discussion and constructive feedback. The accreditation process will also identify areas in which the Human Research Protection Program does not yet meet the standards and to give CAVHS the opportunity to discuss potential program improvements. The accreditation process will be responsive to changes, in federal regulations and to standards that will evolve, based on what AAHRPP learns from accrediting Organizations from research settings. AAHRPP will review all relevant, necessary and de-identified documentation as needed for accrediting the CAVHS. As part of the CAVHS re-accreditation review, there will be a site visit performed by AAHRPP accreditation professionals, which will be done once every five (5) years. Quality Assurance: The government shall evaluate the contractor s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is a Government only document primarily focused on what the Government must do to assure that the contractor has performed in accordance with the requirements of the contract. QUALITY CONTROL: Quality Control is the responsibility of the contractor. The Contractor is responsible for the delivery of quality services to the Government. The Contractor shall develop, implement and maintain an effective Quality Control System which includes a written Quality Control Plan (QCP). The QCP shall implement standardized procedure/methodology for monitoring and documenting contract performance to ensure all contract requirements are met. The Contractors QCP must contain a systematic approach to monitor operations to ensure acceptable services are provided to the Government. The QCP, as a minimum, shall address continuous process improvement; procedures for scheduling, conducting and documentation of inspection; discrepancy identification and correction; corrective action procedures to include procedures for addressing Government discovered non-conformances; procedures for root cause analysis to identify the root cause and root cause corrective action to prevent re-occurrence of discrepancies; procedures for trend analysis; procedures for collecting and addressing customer feedback/complaints. The contractor shall upon request provide to the Government their quality control documentation. Contract Administration and Performance Monitoring Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor. The Contracting Officer Representative (COR) and Program Manager (PM) will assist by monitoring contractor performance and reporting the findings to the Contracting Officer (CO). The COR shall be designated on the authority of the CO at the time of contract award to monitor all technical aspects of the contract. In no event is the COR empowered to change any of the terms and conditions of the contract. Changes in any section of this contract shall be made only by the CO pursuant to a properly executed modification. The types of actions within the purview of the COR s authority are to ensure that the Contractor performs the technical requirements of the contract, and to notify both the Contractor and the CO of any deficiencies observed. A memorandum of designation shall be issued to the COR and a copy shall be sent to the Contractor at the time of contract award setting forth in full the responsibilities and limitations of the COR. Performance Measures: a. ACCEPTABLE PERFORMANCE The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action. b. UNACCEPTABLE PERFORMANCE When unacceptable performance occurs, the COR shall inform the Contractor and the CO. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file. When the COR determines formal written communication is required, the COR shall prepare a Contract Deficiency Report (CDR) and present it to the Contractor's Point of Contact (POC). 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 COR. The Government shall review the Contractor's corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. Inherently Governmental Functions Contractor shall not perform any Inherently Governmental functions in accordance with FAR Part 7.5. Quality Assurance Contractors shall conform to quality assurance standards in accordance with best commercial practices, unless otherwise specified. QASP Preventive Maintenance Number Paragraph in PWS Indicator/Performance Standard Standard for Quality Level Acceptable Quality Level Method of Surveillance Incentive 1 Objective Requires courteous, professional to adhere to all principles, procedures and standards. 100% 100% Observation and random inspection. Positive past performance rating 2 Scope Evaluation requires commendations or recommendations for meeting the standards. 100% 100% Observation and random inspection. Positive past performance rating 3 Scope Re-accreditation review, requires a site- visit performed by accreditation professionals. 100% 100% Observation and random inspection. Positive past performance rating 4 Quality Control Contractor is responsible for the delivery of quality services to the Government. 100% 100% Observation and random inspection. Positive past performance rating CONTRACT DURATION and PLACE OF PERFORMANCE Location: CAVHS, 1300 West 7th Street, Little Rock, AR. 72205 The duration of the Contract shall be a Base year plus four (1) Option years. Effective Date of Contract: shall be the date on the Notice of Award. Tentative Commencement Date of Services: May 1, 2019. Normal Business hours are 8:00am 1:30pm, Monday through Friday excluding Federal Holidays. DELIVERABLES Deliverables listed below shall be normally submitted to the Chief, Research electronically or physically to the address in section 3 of this SOW and become the property of Central Arkansas Veterans Healthcare System (CAVHS). The COR, or other persons designated by the COR, may choose to have specified deliverables submitted directly to the COR electronically or physically to the address in section 3a of this SOW, and become the property of CAVHS. The vendor shall process the accreditation application from CAVHS for suitability, and provide guidance/direction regarding the assessment process, timelines, documents needed, and other instructions as necessary. The vendor shall conduct appropriate on-site assessments as routinely conducted by the vendor\during conformity assessments. The vendor shall conduct appropriate off-site assessments as routinely conducted by the vendor during conformity assessments. The vendor shall provide both written and verbal results of the assessment process, to include non-conformities, as routinely provided by the vendor during conformity assessments. These results should be provided in hard copy or electronic format. If warranted, the vendor shall award accreditation with an award date, and date of expiry. The vendor shall prepare timely and appropriate itemized invoices for work performed. The COR, or other persons designated by the COR, will review all draft and final deliverables within 10 business days to ensure accuracy, functionality, completeness, professional quality, and overall compliance with contract or task order requirements. The vendor shall ensure the accuracy and completeness of all deliverables. The Government will consider errors, misleading statements, incomplete and/or irrelevant information, excessive rhetoric, or repetition as deficiencies and the contractor shall make corrections at no additional cost. Marking and Delivery: The vendor and the COR will finalize the method in which report deliverables are to be submitted and marked for delivery. Report deliverables may be required to be submitted electronically and in hard copy. The list of deliverables is indicated above. All deliverables shall be in the format listed unless otherwise approved by the COR. SECURITY: This project requires privacy and confidentiality. End of Performance Work Statement