Inactive

Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Bethesda, MD 20892, US... Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Bethesda, MD 20892, USA. Description: National Cancer Institute (NCI) Division of Cancer Control and Population Sciences (DCCPS), Surveillance Research Program (SRP) Data Quality, Analysis, & Interpretation Branch (DQAIB), plans to procure on a sole source basis Cancer PathCHART Database Developer Support Services for Unified Tumor Site- Histology Standards from the College of American Pathologists (CAP); 325 Waukegan Road; Northfield, IL 60093 USA. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated 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 541512 and the business size standard is $34.0M. Only one (1) award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract for non-severable services. The Period of performance is for one (1) year upon award of contract. It has been determined there are no opportunities to acquire green products or services for this procurement. The DCCPS both generates new knowledge and seeks to ensure that the products of cancer control research are effectively applied in all segments of the population. Through innovative research initiatives, leadership, and the synthesis of knowledge and its dissemination, we are building this program to be the nation's model for cancer control science. The SRP provides national leadership in the science of cancer surveillance as well as analytical tools and methodological expertise in collecting, analyzing, interpreting, and disseminating reliable population-based cancer statistics. This surveillance infrastructure benefits the public, policymakers, and scientists in understanding changes in cancer incidence and outcomes in all segments of the US population over time. The mission of the DQAIB is to provide essential information for tracking the nation’s progress against cancer and lead the analysis and interpretation of patterns and trends in population-based cancer surveillance data. It provides national leadership to the surveillance community in cancer data collection, quality improvement, education, analysis, interpretation, and reporting of cancer burden. The Cancer Pathology Coding Histology And Registration Terminology (Cancer PathCHART) initiative is a groundbreaking collaboration of 11 global and North American clinical (World Health Organization (WHO) / International Agency for Research on Cancer (IARC), American College of Surgeons, American Joint Committee on Cancer (AJCC)), pathology (International Collaboration on Cancer Reporting (ICCR), College of American Pathologists (CAP)), cancer registry (International Association of Cancer Registries, Surveillance, Epidemiology, and End Results (SEER), Center for Disease Control and Prevention National Program of Cancer Registries, Commission on Cancer), and cancer registrar (North American Association of Central Cancer Registries (NAACCR), National Cancer Registrars Association) organizations that aim to update and harmonize cancer surveillance standards for tumor site-morphology combinations, associated terminology and coding. To support the review, update, and harmonization of these standards, the CAP has developed the Cancer PathCHART database to hold, update, and output the single source of truth for cancer surveillance standards. This database also maps current tumor morphology terminology and site-morphology combinations across standards and stakeholder products, historical entities, and terminology to current versions within a given standard or stakeholder product. As the two most foundational data items collected about cancer patients and their diagnoses, tumor site and morphology regulate much of the subsequent data collected, such as tumor stage, biomarkers, grade, and treatment. If they are inaccurate, the remaining data items are misattributed. Not only is there variation over time in the terminology used by a single data standard to characterize site-specific tumor histologies and associated behavior, but also histology terms can vary across standards from different stakeholders at a given point in time. This variation can cause inconsistencies in cancer surveillance data captured. Systematic inaccuracies can result in misleading cancer statistics and trends. The Surveillance Research Program (SRP) at NCI supports the population-based SEER cancer registry system, is leading the Cancer PathCHART initiative, and provides the associated personnel infrastructure. Through this initiative, tumor site-morphology combinations and associated terminology and coding are being reviewed in a multiphase process (multilevel pathologist review, cancer registrar review, and a statistical impact analysis) to determine if tumor site-morphology combinations are valid (can be entered by registrars), impossible (cannot be entered by registrars), or unlikely (can be entered by registrars after they consult with the medical record and/or treating physician and override a data quality edit). The database for this initiative is housed with the College of American Pathologists. The primary objective of this project is to obtain support services for: a) a Structured Query Language (SQL) Developer to develop and optimize new and existing SQL queries and database schema and b) a Senior Medical Informaticist to train, aid, and oversee the SQL Developer in the design and development of the database for the Cancer PathCHART initiative. SQL queries, functions, and stored procedures need to be scripted, documented, and maintained to extract, transform, and load (ETL) Cancer PathCHART stakeholder product files with tumor site-morphology information into the Cancer PathCHART database; integrate this information into the relational database, determining and linking tumor site-morphology code combinations with associated terms and other related information; generate annual reports and change logs; identify and map site-specific terminology for tumor histologies across standards and within a given standard over time; and generate Pathologist Review Templates in Excel format to support efforts to review site-morphology combinations for validity. This SQL Developer will also load the results of the review process and produce source files for NCI staff to assist in the generation of the 2025 Cancer PathCHART ICD-O-3 Site Morphology Validation List (CPC SMVL) and 2026 CPC SMVL with all morphology terms for the CPC*Search webtool. The NCI SRP is the publisher of the CPC SMVL and associated morphology terminology for the CPC*Search webtool allowing users to search site and morphology terms, codes, and site-morphology validity status. Developer time will also contribute to ingestion and comparison of tumor terminology and codes in the ICD-O-4 beta file as well as associated ICD-O-3.2 to ICD-O-4 mapping, producing reports of changes in codes and/or terms that impact existing CPC SMVL standards. No human subjects data are involved in any of the tasks outlined in the Statement of Work. The database information referred to in this Statement of Work do not reflect aggregated or individual-level data. Rather, it is whether tumor entities are valid within a given tumor site or organ system. The SQL Developer will manage the Cancer PathCHART database architecture and contents. As stakeholders release tumor site-morphology standards and/or associated terminology and codes, the SQL Developer will ETL the source files for those standards into the Cancer PathCHART database; evaluate standards across stakeholder products for differences in terminology, coding, or combinations; and produce files for review by Cancer PathCHART-associated subject matter experts. The SQL Developer will import review results files, produce files with linked standards, codes, and terminology and will generate and provide files for NCI staff to generate Cancer PathCHART products, to include the Cancer PathCHART ICD-O Site Morphology Validation List and the associated standards file with associated WHO and ICD-O terminology. The SQL Developer will import the final Cancer PathCHART standards file generated by NCI staff. The Senior Medical Informaticist will supervise the Cancer PathCHART SQL Developer’s work. The SQL Developer and supervising Senior Medical Informaticist shall participate in 2 to 3 teleconferences per month conducted by NCI. The SQL Developer shall have expertise working with a Structured Query Language relational database design, SQL scripting, knowledge of oncology in general as well as Oncology Data Specialist coding responsibilities and the stakeholder products listed in the tasks below. The Senior Medical Informaticist shall be a physician with pathology informatics background and experience working with the Cancer PathCHART database and its contents. The Contractor shall perform the following technical requirements: Independently, and not as an agent of the Government, the Contractor shall furnish all of the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform this Statement of Work. Please note that the numbering of the following information is directly from a certain part of the SOW document, thus why it does not start with the number one (1). 4.1 ETL and integrate product source files with tumor site and morphology combinations from the Cancer PathCHART stakeholders and collaborators into the Cancer PathCHART database. 4.1.1 Import and integrate content from the following stakeholder products into the database: WHO Classification of Tumours series (5th edition and more recent); WHO International Classification of Diseases for Oncology (ICD-O-3.2 and later); NAACCR’s ICD-O working group Annotated Histology List; the ICD-O-3 Site/Histology Validation List; SEER Solid Tumor Manual rules and tables; United States Cancer Statistics database case counts by site, histology, and tumor behavior; histology terms and codes in the CAP electronic Cancer Protocols (eCPs); ICD-10-CM; ICD-11; and tumor sites and histologies listed in American Joint Committee on Cancer (AJCC) staging manual chapters (8th edition and later). 4.1.2 Conduct standard quality assessments to detect any discrepancies across stakeholder products in tumor site and morphology codes and terminology. Refer to Section 6.0 below for deliverable file requirements. The final format to be specified by the COR. 4.1.3 Produce files detailing the discrepancies listed in 4.1.2 that will be reviewed by subject matter expert pathologists and cancer registrars through the Cancer PathCHART initiative review process. 4.1.4 Import final determinations for discrepancies resolved by subject matter experts using reports produced as stipulated in 4.1.3. 4.2 Produce templates for review by subject matter experts designated by NCI. 4.2.1 Generate Excel files for pathologist review that include tumor histologies by site group with separate worksheets for (1) entities included in the ICD-O-3.2 with counts in the US Cancer Statistics (USCS) database between 2001 and the most recent year of USCS data, as well as any entities for which the Matrix Rule was used to assign behavior, along with WHO terms, (2) entities included in ICD-O-3.2 with no counts in the USCS database between 2001 and the most recent year of data along with associated WHO terms; and (3) new entities in any of the WHO Classification of Tumours books published in print (5th edition or more recent). 4.2.2 ETL the WHO International Classification of Diseases for Oncology, 4th Edition (ICD-O-4) beta file into the Cancer PathCHART database, compare the ICD-O-4 beta file terminology and codes to the existing ICD-O and WHO 5th edition information int eh Cancer PathCHART database, generate review templates for the NCI-led ICD-O Implementation Work Group, and incorporate suggested changes. 4.2.3 ETL the final WHO ICD-O-4 file into the Cancer PathCHART database, compare the ICD-O-4 file terminology and codes to the existing ICD-O and WHO 5th edition information in the Cancer PathCHART database, generate review templates for the NCI-led ICD-O Implementation Work Group, and incorporate suggested changes. 4.3 Import completed Pathologist Review Templates into Cancer PathCHART database and conduct data quality checks. 4.4 Produce source files that NCI staff will use to generate the 2026 CPC SMVL with tumor site and morphology standards for cancer surveillance on an annual basis. 4.4.1 Produce source files for NCI staff to generate the 2026 CPC SMVL using standards from the Cancer PathCHART database, listing all tumor site-morphology combinations with validity status (valid, impossible, or unlikely) as determined by the Cancer PathCHART review process. 4.4.2 Produce files for data quality edits and other purposes based on Cancer PathCHART information. 4.4.3 Generate the CPC Histology Lookup Table for cancer registry software. This table shall include standardized and cleaned data from the list of ICD-O histology codes, all associated terms and behaviors, morphology code diagnosis year implementation date and deprecation date (if applicable), and site-specificity (if applicable). This information will be harmonized across the five following resources: WHO Classifications of Tumours, NAACCR’s ICD-O working group Annotated Histology List, the SEER Solid Tumor Rules, CAP protocols and electronic Cancer Protocols (eCPs), and histology terms and codes included in AJCC Staging editions and systems chapters. 4.5 Annually ETL update stakeholder products and produce change logs documenting changes in tumor site-morphology combinations and associated terminology and coding. 4.6 Map site-specific terminology for tumor entities across standards and within a given standard over time. 4.7 Provide NCI staff (Liaison to the Content Work Group and Liaison to the Database Development Work Group) with access to the Cancer PathCHART database. 5.0 GOVERNMENT RESPONSIBILITIES The NCI Contracting Officer’s Representative (COR) is to provide the necessary information to the Contractor in order for them to complete Sections 4.0 and 6.0 of this SOW. 6.0 REPORT(S) / DELIVERABLES AND DELIVERY SCHEDULE Complete deliverables schedule listed below. All written deliverable products shall be submitted in draft format for review, comment and approval by the COR. Final copies of approved drafts shall be delivered to the COR within five (5) business days after receipt of the Government’s comments. All written draft and final deliverable products shall be submitted in electronic copy for review and comment. All deliverables shall be sent electronically as computer readable files, unless approved by the COR per the following deliverable schedule. DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE 4.1 Files loaded into Cancer PathCHART database #1 (Task 4.1.1) Email notification to COR that stakeholder product content has been imported and integrated into the Cancer PathCHART database 30 calendar days after new standard has been released #2 (Task 4.1.2) Computer readable file (Excel, CSV, or SAS) reporting discrepancies across stakeholder products in tumor site and morphology codes and terms. Final format to be specified by the COR 45 calendar days after new standard has been released for codes and 75 calendar days for terms #3 (Task 4.1.3) Computer readable review template (Excel) showing discrepancies reported in Task 4.1.2 with data fields for subject matter expert adjudication of each discrepancy 60 calendar days after new standard has been released for codes and 90 calendar days for terms #4 (Task 4.1.4) Email notification to COR that subject matter expert reviews of discrepancies have been imported and integrated into the Cancer PathCHART database 30 calendar days after subject matter expert review 4.2 Review templates generated for subject matter experts #5 (Task 4.2.1) Organ site group-specific Excel files for subject matter expert pathologist review 30 calendar days after discrepancy reviews imported and integrated into database #6 (Task 4.2.2) Excel review templates for ICD-O Implementation Work Group showing mapping of ICD-O-3.2 to beta version of the ICD-O-4, changes in site or morphology codes or terms between these two sources, and what sites the morphology codes were impossible in the CPC SMVL. Email notification to COR when completed review template has been ingested. 90 days after receipt of ICD-O-4 beta file #7 (Task 4.2.3) Excel review templates for ICD-O Implementation Work Group showing mapping of ICD-O-3.2 to ICD-O-4, changes in site or morphology codes or terms between these two sources, and what sites the morphology codes were impossible in the CPC SMVL. Email notification to COR when completed review template has been ingested. 90 days after receipt of ICD-O-4 final file #8 (Task 4.3) Computer readable file (Excel, CSV, or SAS) documenting findings from data quality checks on the imported review templates. Final format to be specified by the COR Within 30 calendar days of receiving completed review templates 4.4 Source files for CPC SMVL #9 (Task 4.4.1) Computer readable (Excel, CSV, or SAS) source files of tumor site, histology, behavior, terms, codes, validity standards, and year(s) were effective. Final format to be specified by the COR May 15, 2025 or sooner as designated by the COR #10 (Task 4.4.2) Computer readable files (Excel, CSV, or SAS) for data quality edits. Final format to be specified by the COR May 15, 2025 or sooner as designated by the COR #11 (Task 4.4.3) CPC Histology Lookup Table in computer readable formats (Excel, CSV, SAS, JSON, xml) May 15, 2025 or sooner as designated by the COR #12 (Task 4.5) Change logs showing changes between updated stakeholder products and existing standards in Cancer PathCHART database in computer readable formats (Excel, CSV, SAS, etc.) May 15, 2025 or sooner as designated by the COR #13 (Task 4.6) Computer readable file (Excel, CSV, SAS, etc.) showing mapping of site-specific terminology for site-morphology combination entities and associated coding May 15, 2025 or sooner as designated by the COR #14 (Task 4.7) Email notification to COR that NCI staff liaisons to the Content Work Group and the Database Development Work Group have been given access to the Cancer PathCHART database Within 30 days of the beginning of the Period of Performance 7.0 AWARD TYPE This is a firm fixed price, non-severable purchase order. 8.0 PERIOD OF PERFORMANCE The Period of Performance shall be for twelve (12) months from the date of the award. 9.0 PLACE OF PERFORMANCE All service shall be performed at the Contractor’s facility. 10.0 PAYMENT Payment shall be made _quarterly after satisfactory completion and acceptance of the deliverables stated in Section 6.0. Payment authorization requires submission and approval of invoices to the COR and the NIH Office of Financial Management (OFM), in accordance with the attached payment provisions. It is anticipated that these support services are to be provided by the College of American Pathologists (CAP). The Vendor is the only known source that can meet all of the technical requirements in the Statement of Work. The proposed Vendor is the ultimate authority on how tumors are reported and what information is contained in their electronic Cancer Protocols (eCPs) in North America. On staff, they have medical informaticians who created and are experts in the database for the Cancer PathCHART initiative, ingestion of tumor site-morphology combination standards from stakeholders into the database, generation of the standards review templates that the subject matter expert pathologists and registrars review to determine the Cancer PathCHART standards for cancer surveillance, and content of files that NCI uses to create the CPC SMVL and associated standards and terminology search webtool (CPC*Search). It is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition and would result in unacceptable delays in fulfilling the NCI’s programmatic requirements. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirements, 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 the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:30PM ET, on July 22, 2024. All responses and questions must be in writing emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.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. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference 75N91024Q00103 on all correspondence.