Inactive

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) intends to procu... The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) intends to procure, on a sole source basis, storage and distribution services for LP’s clinical patient paper reports archives and clinical and research specimens from EPL Pathology Archives, LLC (EPL), 45610 Terminal Drive, Sterling, Virginia 20166-4300. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). 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)(2); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System (NAICS) code is 493190 and the business size standard is $32 million. 1.0 BACKGROUND The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), 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 (NIH) patients and specimens 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. The LP must continue to store a certain portion of these patient materials offsite due to space limitations in building 10. The LP currently archives 438.75 cubic feet (351 boxes) of research documents and clinical patient records; 1,670.12 cubic feet of paraffin embedded pathology tissue blocks, and stained slides dating back to the 1980’s that are still requested for recruits and reviewed by clinical and research staff. The required services are for a continuation of storage and distribution of these materials. Materials are stored in Good Laboratory Practice (GLP) facilities that are environmentally controlled and protected against hazards. The Contractor provides facility access to the storage location(s) of any or all government patient materials and provides the return or delivery of all or a portion of the materials. 1.1 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 no more than 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. 2.0 SCOPE The 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. The Contractor shall ensure that all environmental hazards are prevented (e.g., protection from fire, flood, smoke, and insects). The Contractor shall provide facility access to the storage location(s) of any or all government patient materials. The Contractor shall provide the return or delivery of all or a portion of the materials. The Government may request retrieval of material(s) for clinical or research applications, and then returned to storage (tissue blocks & slides, and paper records). 3.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS 3.1 CONFIDENTIALITY The Contractor shall ensure complete patient confidentiality of material(s). The Contractor shall maintain patient records in the form of pathology reports with identifiers (names, medical record numbers, case #’s, age, sex, clinical histories) and shall not release material(s) to any third-party requesters, unless requested in writing by the Contracting Officer’s Representative (COR). The 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. All materials stored are the sole property of NIH, NCI, CCR, LP. 3.2 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, the Contractor shall return, or deliver such materials. Material retrieval and deliveries shall be completed by the Contractor within 48 hours of receipt the writer request. The anticipated method of notification is email. 3.3 MAINTENANCE OF RECORDS The Contractor shall maintain written records (inventory and transaction records) on materials stored at the Contractor’s facility. Records shall consist of correspondence between Contractor and the Government, information provided by the Government on the type of material included in the stored materials, and designation of Government’s ownership of the materials. The Government may review and obtain copies of the Contractor’s records upon request. 3.4 SERVICE EXCLUSIONS The Contractor shall not be responsible for any lost/destroyed material due to Acts of God. 3.5 PERSONNEL QUALIFICATIONS All Contractor employees who handle Material(s) shall be trained in Current Good Manufacturing Practices (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 Federal Privacy Act. Contractor shall provide evidence that personnel are qualified to handle the government’s Material(s) and have been trained and acknowledge compliance with adherence to the laws that govern patient privacy. 4.0 TYPE OF ORDER This is a Firm-Fixed-Price Purchase Order for severable services. Funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not roll over for use in other periods. 5.0 PERIOD OF PERFORMANCE The anticipated period of performance shall be for twelve (12) months plus four (4) twelve-month option periods as follows: Base Period: 09/01/2022 – 08/31/2023 Option Period 1: 09/01/2023 – 08/31/2024 Option Period 2: 09/01/2024 – 08/31/2025 Option Period 3: 09/01/2025 – 08/31/2026 Option Period 4: 09/01/2026 – 08/31/2027 6.0 PLACE OF PERFORMANCE All work shall be performed at the Contractor’s facility. 7.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR EPL facilities are environmentally controlled, protected against hazards, and provide GLP-compliant archive services. Additionally, EPL is located within the Washington–Baltimore metropolitan area and provides no more than a 48-hour turnaround of any requested items, which ensures adequate support to NCI researchers and clinicians. After contacting similar companies in the industry, the LP and Office of Acquisitions (OA) are unaware of another facility within a reasonable radius of the NIH Bethesda campus that provide all the required services. Utilizing a different vendor, including for partial services outside of the Washington–Baltimore metropolitan area, would incur substantial switching cost (package, inventory, and transport) and would significantly disrupt the projects being conducted by the LP. 8.0 RESPONSE INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party, especially a small business, believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in enough detail to allow NCI to determine if the party can perform the requirement. All responses must be submitted via email to Adam Hernandez, Contracting Officer at adam.hernandez@nih.gov. Responses are due no later than 3:00 P.M. ET Friday, May 13, 2022 (05/13/2022). 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 determining whether to conduct a competitive procurement. To receive an award, Contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov, and have Representations and Certifications filled out. Reference 75N91022Q00078 on all correspondence.