Maintenance Agreement for Storage and Distribution Services for Research and Pathology Reports and Pathology Paraffin Embedded Tissue Blocks and Tissue-Fixed Slides - 6 Month Extension

Document Type: Notice of Intent Contract Number: 75N91019P00657 - Modification P00002 Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E132, Bethesda, MD 20892, UNITED STATES Description: The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), the Laboratory of Pathology's (LP), Office of Acquisitions (OA) plans to procure on a sole source basis with EPL Pathology Archives, Inc. (EPL); 45610 Terminal Drive Sterling, VA 20166-4300 for refrigerated storage and distribution services for paper research and pathology reports and pathology paraffin embedded tissue blocks and tissue fixed slides. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b) (1)(i) using simplified acquisition procedures for commercial acquisitions and FAR 52.217-8 option to extend services. The North American Industry Classification System Code is 493120 and the business size standard is $25.5 million. This award will be a modification to existing contract number 75N91019P00657 to extend services for six (6) months under the authority of FAR 52.217-8 option to extend services. This will be awarded as a severable firm fixed price type contract. The base period of performance of twelve (12) months with one (1) 12-month option period will be extended for an additional six (6) months as follows: Base Period: September 1, 2019 through August 31, 2020 Option Period One: September 1, 2020 through August 31, 2021 Option to Extend Services: September 1, 2021 through February 28, 2022 It has been determined there are no opportunities to acquire green products or services for this procurement. BACKGROUND The NCI, CCR, LP provides diagnostic services for the Clinical Center at the National Institutes of Health. The department provides pathological diagnosis of specimens submitted incidental to standard care and clinical investigation of National Institutes of Health patients and submitted by outside health organizations. As a result of LP's clinical and research missions, pathology blocks, slides, images, and hardcopy patient reports must be stored and available indefinitely. LP must continue to store a certain portion of these patient materials offsite due to space limitations in Building 10. PURPOSE AND OBJECTIVE The purpose is to procure storage and distribution services for paper research, pathology reports, and pathology paraffin embedded tissue blocks and tissue fixed slides used in the NCI, CCR, LP. The objective is to procure the services of a local facility that is environmentally controlled and protected against hazards which provides GLP-compliant archive services and specializes in Pathology. The Contractor shall provide a 48-hour turnaround to provide the necessary reports or slides, which ensures adequate turnaround times for LP's services provided to NIH Researchers and Clinicians. Contract Requirements: SCOPE Contractor shall provide storage and distribution services for approximately 438.75 cubic feet (351 boxes) of paper research and pathology reports; and 1,670.12 cubic feet of pathology paraffin embedded tissue blocks and tissue-fixed slides. Materials shall be stored in a climate-controlled environment at the Contractor's Storage Facility for the period contracted. The Contractor shall provide facility access to the storage location(s) of any or all government patient materials. Contractor shall provide the return or delivery of all or a portion of the materials. CONFIDENTIALITY Contractor shall ensure complete patient confidentiality of material(s), Contractor has patient records in the form of pathology reports with identifiers (names, medical record numbers, case #s, age, sex, clinical histories) and shall not release to any third-party requesters, unless requested in writing by the Contracting Officer's Representative (COR). Contractor shall abide by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (45CFR 160 & 164) and the Federal Privacy Act of 1974. Government Personnel shall have access to the storage facility to review contents and storage location of Government materials. The Contractor shall provide facility access to the storage location(s) of any or all government patient Materials TRANSACTIONS Upon receipt of Government's written request (approximately 50 times per year) for the return, or delivery of all or a portion of the materials, Contractor shall return, or deliver such materials. Material retrieval and deliveries shall be completed by the Contractor within 48 hours of receipt. Method of notification being email with a purchase order attached for each written request. All materials stored are the sole property of NCI, CCR, LP. MAINTENANCE OF RECORDS Contractor shall maintain written records (inventory and transaction records) on Materials stored at the Contractor's Facility consisting of correspondence between Contractor and the government, information provided by the government on the type of material included in the Materials and designation of government's ownership of the Materials. The Government may review Contractor's records with respect to the materials stored, with the exception of locator codes, and copies may be obtained or originals inspected at Contractor's location. SERVICE EXCLUSIONS The contractor shall not be responsible for any lost/destroyed material due to Acts of God. PERSONNEL QUALIFICATIONS All Contractor employees who handle material(s) shall be trained in cGMP regulations and in the specific standard operating procedures for their activities. All Contractor Employees who maintain Government's material(s) shall be trained and acknowledge compliance with the HIPAA and Privacy Act. Contractor shall provide evidence that Personnel are qualified to handle the Government's material(s) and have been trained and acknowledged compliance with adherence to the laws that govern patient privacy. PAYMENT Payment shall be made monthly in arrears. Justification: The NCI, CCR, LP currently utilizes EPL for archiving these materials. The current contract 75N91019P00657 expires on August 31st, 2021. NCI, CCR, LP has an urgent need to continue these recurring services and it would be impractical to package, inventory, and transport these materials to another facility prior to contract expiration. For these reasons, the Government requires continued performance of services under the authority of FAR 52.217-8 Option to Extend Services for a period that shall not exceed 6 months. Under contract 75N91019P00657, the Option to Extend Services under the authority of FAR 52.217-8 was not evaluated as part of the initial competition. Therefore, the purpose of this justification is to satisfy the requirements of FAR 17.207(f) and provide reasonable justification for this modification pursuant to the procedures of FAR 13.106-1(b)(1)(i) for purchases not exceeding the simplified acquisition threshold. The Contracting Officer has determined that due to the urgency and dollar value below the simplified acquisition threshold only EPL is reasonably available to meet the Government's need. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 4:00 PM EST, on August 20, 2021. All responses and questions can be emailed to John Turner, Contracting Officer via electronic mail at john.turner@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91019P00657 on all correspondence.