Maintenance Agreement for the Storage and Distribution Services

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 Acquistions (OA) plans to procure on a sole source basis with EPL Pathology Archives; 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) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System Code is 493120 and the business size standard is $25.5 million. Only one award will be made as a result of this solicitation. This will be awarded as a severable firm fixed price type contract. The base period of performance shall be for twelve (12) months with one (1) 12-month option period as follows: Base Period: September 1, 2019 through August 31, 2020 Option Period One: September 1, 2020 through August 31, 2021 It has been determined there are no opportunities to acquire green products or services for this procurement. The Laboratory of Pathology (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. 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 Laboratory of Pathology, CCR, NCI. 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 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 Laboratory of Pathology, National Institutes of Health. 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. NCI has determined that EPL Pathology Archives is uniquely qualified to provide the needed storage and distribution services. EPL Archives facilities are environmentally controlled, protected against hazards, and the company provides GLP-compliant archive services. EPL is the only storage facility LP has utilized for archiving and all of its materials are presently located there. In addition to EPL's quality service history with the LP, it would be impractical and non-beneficial to NCI to relocate the materials. LP's materials have been stored at EPL for more than a decade and the cost it would take to package, inventory, and transport to another facility would be prohibitive. For the aforementioned reasons, EPL Pathology Archives is the only known source to meet the Government needs for this requirement. 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 2, 2019. All responses and questions can be emailed to Ronette Collins, Contract Specialist via electronic mail at ronette.collins@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: 75N91019Q00099 on all correspondence.