SPECIAL NOTICE
Q -- Tissue sample and medical record preparation for Sherlock-Lung study among never-smoking histologically confirmed lung cancer cases in Singapore
- Notice Date
- 8/21/2020 11:19:38 AM
- Notice Type
- Special Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- NIH National Cancer Institute Rockville MD 20850 USA
- ZIP Code
- 20850
- Solicitation Number
- 75N91020Q00176
- Response Due
- 8/26/2020 12:00:00 PM
- Archive Date
- 09/10/2020
- Point of Contact
- Megan Kisamore, Phone: 2402765261
- E-Mail Address
-
megan.kisamore@nih.gov
(megan.kisamore@nih.gov)
- Description
- 1.0�� �DESCRIPTION The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) plans to procure, on a sole source basis, tissue samples and medical records preparation for Sherlock-Lung study from the National University of Singapore, at 21 Lower Kent Ridge Rd., Singapore 119077, Singapore. 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)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the small business size standard is $16.5 million. � It has been determined there are no opportunities to acquire green products or services for this procurement.� 2.0�� �BACKGROUND� Globally, over a million people are diagnosed with lung cancer each year, making it the most common type of cancer in the world. In addition, lung cancer is the leading cause of cancer death among both men and women, accounting for ~25% of all cancer deaths in the United States (U.S.) and ~19% of cancer deaths worldwide. Since lung cancer in smokers is highly preventable and targeting strategies for lung cancer screening have focused on smokers, it is critical to develop a thorough understanding of nonsmoking lung cancer to develop rational strategies for screening, prevention, and treatment. Moreover, the characterization of the risk factors and endogenous processes involved in lung tumorigenesis may improve prevention of lung cancer also in smokers. Lung cancer in never-smokers includes approximately 10-25% of all lung cancers worldwide; ranks among the most common causes of cancer mortality; and, has a distinct natural history; high proportion of adenocarcinoma histology; likely different profile of oncogenic mutations; and response to targeted therapy compared to lung cancer in smokers. Although a few risk factors are known to contribute to the etiology of lung cancer in never smokers, a large fraction of cancer cases cannot be explained by established environmental and genetic risk factors, highlighting the need for research in this area. �One promising approach to identify the etiological factors involved in lung tumorigenesis in never smokers is based on the study of the �mutational signatures� that the exogeneous and endogenous processes leave on the tumor tissue and surrounding areas.� The U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Occupational and Environmental Epidemiology Branch (OEEB) is conducting an international whole-genome sequencing study of lung cancer tumors from never-smoking women in Asia, the U.S., Europe, South America and Africa to identify exposure-related mutational signatures to extend NCI�s findings, and will compare results with signatures identified in cases NCI is analyzing from China, Asia, the West, and other regions as part of the Sherlock-Lung study. Singapore has been selected as one of the key study sites for an epidemiology study of lung cancer etiology in Asia because of the presence of industries and a port which services thousands of ships per year that give rise to substantial occupational and environmental exposures to known lung carcinogens that are likely to produce distinct mutational signatures in lung tumors. These industrial facilities and the port are located in the Western part of Singapore.� 3.0�� �SCOPE To support the Sherlock-Lung study, the NCI requires at least 250 frozen tumor and at least 375 normal lung tissues and 125 blood samples from 125 never-smoking lung cancer cases who have surgery at hospitals that serve the populations in the Western part of Singapore. The Contractor shall obtain samples from stored frozen tumor tissue and adjacent normal lung tissue, a peripheral blood sample, an accompanying H & E diagnostic slide for each lung pathologic sample, a copy of the pathology report, and a digital copy of the CT scan from cases and send files to the NCI based on protocols that will be provided by NCI via email to the Contractor within 15 business days after award. All samples, pathology reports and CT scans shall be coded and shall not have any personally identifiable information (PII) attached. Shipping costs for biological samples shall not be included in the price quote. Shipping shall be coordinated with NCI using the NCI shipping service.� 4.0�� �PURCHASE ORDER REQUIREMENTS / TASKS The Contractor shall perform the following tasks: 4.1�� �Provide a monthly report to NCI, via email, containing the following: In the previous month number of cases, number of lung tissues, number of blood samples, number of supporting documents including pathology report and CT scan report, and number of data files with CT scan data. 4.2�� �Select 125 never-smoking histologically confirmed lung cancer cases of which at least 100 cases should have the adenocarcinoma histology with fresh-frozen tumor tissue and adjacent normal tissue samples from these 125 cases enrolled in Singapore. 4.3�� �Cut up at least 2 frozen tumor tissue samples with at least 50% tumor in each lung tumor from each of the 125 lung cancer cases and store it in 1.8ml sterile cryovials. Evaluate each lung sample by a H & E stained slide to demonstrate the percentage of tumor cells to NCI. All samples shall be coded and shall not have any PII attached. Prepare frozen lung tissue samples and H & E slides or a photomicrograph for all tumor lung tissue samples for shipment to NCI.� 4.4�� �Cut up at least 3 adjacent frozen normal lung tissue from each of the 125 lung cancer cases and store it in 1.8ml sterile cryovials. Evaluate for each lung sample a H & E stained slide to demonstrate the tissue is normal. All samples shall be coded and shall not have any PII attached. Prepare frozen lung tissue samples and H & E slide or a photomicrograph for all normal lung tissue samples for shipment to NCI.� 4.5�� �Prepare from each of the 125 lung cancer cases an aliquot of at least 1 ml of whole blood or a buffy coat sample derived from at least 1 ml of whole blood, or at least 2 ug of DNA derived from a buffy coat sample. All samples shall be coded and shall not have any PII attached. Prepare frozen samples for shipment to NCI according to protocol provided by NCI.� 4.6�� �Complete a study subject log (to be provided by NCI, in Excel file format) at the time of each sample shipment that includes the date of diagnosis, type of procedure used to obtain the sample, age and sex of study subject. Securely transmit to NCI.� 4.7�� �Details of 4.2 � 4.6 shall be provided to the Contractor in a protocol by NCI within 15 business days of award. 4.8�� �Submit an electronic copy of the pathology report, the pre-surgery CT scan report, and the CT scan itself from each subject to NCI. �All pathology reports and CT scans and CT reports shall be coded and shall not have any PII attached. Send securely electronic files to NCI.� 4.9�� �Complete the final study subject log (to be provided by NCI, in Excel file format) to include the date of diagnosis, type of procedure used to obtain the sample, age and sex of study subject. Securely transmit to NCI. 5.0�� �TYPE OF ORDER This is a firm fixed price purchase order.� 6.0�� �NON-SEVERABLE SERVICES The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 7.0�� �PERIOD OF PERFORMANCE The anticipated period of performance shall be 12 months from the date of award. � 8.0�� �PLACE OF PERFORMANCE All work shall be performed at the Contractor�s facility. 9.0�� �REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All electronic deliverables shall be submitted for review and comment by the Government�s technical point of contact (TPOC) (TBD at award), for a review period not to exceed fifteen (15) business days, in accordance with the following deliverables table below: DELIVERABLE & TASK# / DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS / DUE DATE 1. Task 4.1 - Monthly progress report in Excel workbook. Due:�1 month after award; and on the last day of each month thereafter. 2.�Task 4.2-4.6�-�Lung tissue and blood samples for first third of study subjects.�H&E slides or photomicrograph for each lung tissue samples for first third study subject samples, submitted as an electronic copy in the form of JPEG files. Study subject log in Excel workbook for first third of study subject samples. Due: Prepare shipments of lung and blood and H&E slides (or photomicrographs) and study subject log within approximately four months of award. 3.�Task 4.2-4.6� - Lung tissue and blood samples for second third of study subjects.�H&E slides or photomicrograph for each lung tissue samples for second third study subject samples, submitted as an electronic copy in the form of JPEG files. Study subject log in Excel workbook for second third of study subject samples. Due: Prepare shipments of lung and blood and H&E slides (or photomicrographs) and study subject log within approximately eight months of award. 4.�Task 4.2-4.6�-�Lung tissue and blood samples for final third of study subjects.�H&E slides or photomicrograph for each lung tissue samples for final third study subject samples, submitted as an electronic copy in the form of JPEG files. Study subject log in Excel workbook for final third of study subject samples.� Due: Prepare shipments of lung and blood and H&E slides (or photomicrographs) and study subject log fifteen (15) business days prior to purchase order expiration date. 5. Task 4.8� -�Electronic copy of pathology report in the form of PDF files; the pre-surgery CT scan report in the form of PDF files; and the CT scan as digital picture of Computed Tomograms.� Due: (15) business days prior to purchase order expiration date. 6. Task 4.9 -�Final study subject log in Excel workbook. Due:�(15) business days prior to purchase order expiration date. 10.0�� �INSPECTION AND ACCEPTANCE CRITERIA Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.� HHS guidance regarding accessibility of documents can be found at: http://www.hhs.gov/web/section-508/making-files-accessible/index.html;� Federal Government-wide guidance regarding accessibility of documents can be found at: https://www.section508.gov/best-practices, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF. 11.0�� �INVOICE SUBMISSION / PAYMENT Payment shall be made three times, after delivery and acceptance of 1) deliverable 2, 2) deliverable 3, and 3) deliverables 4-6, in accordance with section 9.0 above. Payment authorization requires submission and approval of invoices to the NCI TPOC and NIH Office of Financial Management (OFM). Electronic Email Submission: The current national emergency and the need to protect Federal and Contractor staff has resulted in a change to NIH�s invoice submission process. Effective Wednesday, April 1, 2020, all NIH contractors/vendors invoices should be sent electronically via email to the NIH OFM and the NIH Contracting Officer (CO) using the electronic submission instructions contained in Attachment #1. Electronic invoice submission shall remain in effect until the Government formally notifies the Contractor of a return to mail-in invoice procedures detailed in this purchase order. The National University Health System (NUHS) is an integrated academic public health system whose hospitals are located in the Western part of Singapore and serves patients who work in and live in proximity to industrialized sections of Singapore and Singapore�s port. Hospitals within the NUHS diagnose and conduct surgery for lung cancer patients within this region of Singapore, which is the only population within Singapore that can be studied because of its distinct occupational and environmental exposures. The National University of Singapore (NUS) is a comprehensive research university which is the designated academic component of the NUHS. Within the NUS, the Saw Swee Hock School of Public Health is the designated institution for public health research work including epidemiology. Further, the NUS Saw Swee Hock School of Public Health is the only institution within the NUHS that is designated to conduct epidemiology research and is the sole vendor in Singapore that has access to biologic samples including the required frozen lung tumor and normal lung tissues and blood samples from never-smoking lung cancer cases collected within NUHS hospitals for epidemiology research purposes. In addition, the NUS is the only vendor in Singapore that has the capability to conduct epidemiology studies of lung cancer within the NUHS hospital system due to the unique capabilities of its staff and experience in conducting epidemiologic public health research. It is also the sole School of Public Health in Singapore and has extensive expertise in conducting occupational and environmental epidemiology studies and coordinating multi-hospital studies of cancer, including lung cancer, within the NUHS hospital system.� The NCI conducted extensive internet and literature searches (i.e. PubMed and Scopus) and discussion with investigators and epidemiologists in Asia. The National University of Singapore is identified as the only existing vendor with access to the required samples from never-smoking lung cancer cases who are diagnosed and have surgery in hospitals within the NUHS. This notice is not a request for competitive quotation. However, if any interested party, especially a small business, believes it can meet the above requirements, it may submit a proposal/quote/capability statement for the Government to consider. The response 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. �All responses must be sent via email to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov by no later than 3:00 PM EST, on Wednesday, August 26, 2020 (8/26/20). 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 through SAM.GOV. Reference: 75N91020Q00176 on all correspondence.
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