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Request for Information for: Clinical Data on Residents of Long-Term Care Facilities to Support CDC Programs and Emergency Response This is a Request for Information (RFI) only to obtain information r... Request for Information for: Clinical Data on Residents of Long-Term Care Facilities to Support CDC Programs and Emergency Response This is a Request for Information (RFI) only to obtain information requested herein. It is not a request for proposal and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this notice. All responses shall remain with the Government and will not be returned. A. Background and Need CDC needs access to analysis-ready clinical data for residents of long-term care facilities (LTCFs) for surveillance and epidemiologic studies in support public health programs and emergency response. LTCF residents represent a vulnerable population with a higher risk of poor health outcomes. Nationwide, over 2 million people reside in LTCFs, including skilled nursing facilities and assisted living facilities. Insights from analyses of clinical data about this unique and vulnerable population will inform national, state, and local public health programs, initiatives, and interventions to protect health and quality of life. CDC needs regular and ongoing access to comprehensive, longitudinal, person-level clinical and facility data for a large, nationally representative sample of LTCF residents throughout the United States. Comprehensive, person-level clinical data includes residents’ demographic characteristics, length of stay, diagnoses, medications, immunizations, allergies, vitals, assessments, and laboratory test results. Longitudinal data provides the ability to track residents across multiple stays within a facility and potentially across multiple stays at different facilities. The data will be used for studies on conditions or care during residents’ stay in institutionalized long-term care facilities. The data can be leveraged to address a range of CDC public health priorities, including risk factors for and outcomes of antibiotic-resistant infections, surveillance of antimicrobial and antibiotic use, respiratory viruses, blood pressure control, hypertension, diabetes, healthcare-associated infections, and many other chronic and infectious conditions that affect LTCF residents. Facility-level characteristics are important to better understand and account for factors associated with facility-level variability in risk of COVID-19 and other outcomes associated with healthcare quality. B. Purpose The purpose of this acquisition is for the CDC to obtain access to analysis-ready, comprehensive, de-identified, person-level clinical data for residents of LTCFs from Contractor. These data will be used by CDC personnel (defined as CDC employees, fellows, and subcontractors) to address public health priorities that focus on this unique and vulnerable population. These data will allow CDC personnel to conduct complex analysis on disease patterns, progression, and health outcomes; evaluate clinical guidelines uptake, treatments, and interventions; and conduct public health surveillance. CDC will share findings and reports generated using the data with other federal, state, local, territorial, and tribal governmental partners, non-governmental organizations, and the general public as needed to disseminate key information to stakeholders and the scientific community. CDC’s Requirements include: Contractor shall deliver the data to CDC using a secure method that is mutually agreeable to CDC and Contractor. Contractor shall ensure that all CDC data security and privacy regulations are followed. Contractor shall evaluate and notify CDC of all data elements known or suspected to contain individually identifiable health information (i.e., protected health information (PHI)). Ongoing access to data for a minimum of one year after termination of the contract to allow for continued or new analyses and completion and publication of analyses initiated during the period of performance. Regular: data are updated at a minimum of every 3-6 months. Timely: data have maximum lag of 30 days when first made accessible to CDC. A longer data lag be acceptable if it results in higher quality (i.e., more complete, clean, analysis-ready) data. Data dictionaries for each of the tables that include variable names, definitions for each variable, and algorithms and formulas for any derived variables. The data dictionary will include a note for potential PHI variables. Data use guide that provides sufficient detail about relational databases and how to relate similar variables across data sources, with a common use case example. Summary information for each data table with each data delivery that allow for comparison of key metrics for the updated data transmission. Summary information to include unit of analysis for each table (e.g., facility, resident, encounter/visit); number of observations; number of unique facilities, residents, or encounters/visits; ranges and averages of values; and number or proportion of missing values. HIPAA “limited”: data are prepared and delivered to CDC in accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to the level of a “limited” dataset according to 45 CFR 164.514(e). Timeframe: historical data beginning in 2017 through the most recent available. Training on data structures, variables, and use for both novice and advanced analysts, including data use and analytic techniques. Technical support and professional services. C. Requested Information Access to analysis ready, comprehensive, resident- and encounter-level clinical information, medication order and administration information, laboratory orders and results, and facility characteristics with weights. Data should be regular, timely, longitudinal, and limited. Please provide a response to ALL questions. Describe the composition of your company’s LTCF clinical data, including the source of clinical data; number, distribution, and characteristics of different LTCF types (e.g., nursing home, assisted living); geographic distribution; and representativeness of LTCFs nationally. Describe how your company would provide CDC with LTCF data and, if relevant, analytic tools. For example, by delivering analytic data files to CDC (for storage and analysis in CDC’s cloud environment) or by providing CDC staff with access to a data and analytics platform. Please provide details and dependencies (e.g., max number of CDC users on a platform). Describe the frequency of data updates that can be provided to CDC and the recency of data at the time of data delivery or update. Describe if there are any dependencies between frequency and recency of data and data quality. CDC requires comprehensive resident and encounter clinical data including the following. Describe how your company can meet this need and the quality of the data (e.g., completeness overall and variation by facilities or by facility type). Resident demographic characteristics, such as, age in years, race, ethnicity, language, disability, sex and/or gender (if possible, please clarify whether information represents sex at birth, sexual orientation, and gender identity), socioeconomic status, insurance type, and other indicators of social determinants of health. If available, information on residential location prior to LTCF admission. Room characteristics, including private vs. shared room and roommate data if available. Payer at resident or encounter level to assess over time. If available, any information on care provider. Encounter (or stays) and encounter types, including admission and discharge dates to assess short- and long-term stays, with a facility ID. Resident clinical data and/or health record data including but not limited to: allergy, vitals/biometrics, patient assessment with information to understand functional and cognitive limitations, observations, care profile, diagnosis and condition codes (ICD and SNOMEDs as available) with date of onset and date of resolution, listing(s) of comorbidities, procedure and/or treatment information, dates and status of discharge(s), dates and location (i.e., in or out of facility) of death (as available), and immunization, medication, and laboratory data as described below. Dates provided as mm/dd/yyyy for date of death, admission date, discharge date, dates of service, onset and diagnosis dates, and date medication/procedure ordered, completed, start, stop, scheduled, and performed. Describe how your company can provide immunization information including order dates and administration of immunizations within the LTCF stay as well as historic updated immunization history of the resident. Describe any validation or verification of immunization data that can ensure completeness. Describe how your company can provide medication order and/or administration data, including medication type (e.g., NDC code), route, strength, form, quantity, frequency, and associated dates, as well as prescribing indication. Describe how your company can provide comprehensive laboratory data (if available, including in-house testing) with results (qualitative and quantitative) and appropriate reference ranges (as appropriate) using standardized coding terminology such as LOINC, CPT, SNOMED, or other systems. Describe if and how your company can provide microbiology data (including specimen type, collection date, results, and susceptibility information). Describe what approaches or methods (e.g., date shifting) are applied to the data to meet criteria for a HIPAA “limited” dataset while retaining important resident demographic and clinical information. Describe how your company ensures data are high quality and analysis ready for end users (i.e., CDC analysts). Examples of relevant information include quality control checks, use of standard variables and code sets or a common data model (e.g., OMOP), use of medical coding systems (i.e., ICD-10-CM, CPT, SNOMED, NDC, LOINC, etc.), use of specific modules for medication and laboratory data, clear database organizational structures. Describe data quality and completeness by facility, the factors that affect data quality, and how users are able to assess quality and completeness from each facility. Describe how your company can provide facility characteristics that can be linked to resident-level data tables and elements. Facility characteristics of interest include: Facility type: skilled nursing, assisted living, independent living Facility location: 5- or 3-digit ZIP code; urban/rural MSA designation, and other information about the geographic area in which the facility/entity is located that relate to social and structural determinants of health. Facility number of beds, census over time, and any other information about room organization Facility-level resident information: % aged 65+ years, % aged 85+ years, % female, % short-stay and long-stay residents, and payer make-up Facility CMS Certification Number (CCN) or other standard facility identifier Facility ventilator capacity and number of ventilator capable beds Facility staffing data Facility status the affects availability of clinical data: open, closed, changed ownership, changed health record services, and dates of noteworthy changes Describe how your company can provide facility-level weights to calculate national estimates. Describe how your company can provide longitudinal resident data, including the ability to link resident’s records across time (within a facility and, ideally, across LTCF facilities within your dataset). Describe availability of a longitudinal resident ID unique to an individual over time (years) and ideally across facilities. Describe how your company can provide external clinical or registry data for LTCF residents, such primary care, specialty care, external laboratory testing information, hospital care, immunization registries, and death registry information using the consistent resident ID described above. Describe completeness of external data sources and verification and validation methods used by your company to ensure accuracy of data and of person-level linkages. Briefly describe the methods used for linking resident records across data sources. D. Instructions Responders to this RFI may include commercial or not-for-profit organizations, including teaming arrangements/partnerships or joint ventures. Please provide the following information on page 1 of your response: a. Unique Entity Identification Number b. Company Name c. Company Address d. Company Point of Contact, phone number and email address. e. Type of company under North American Industry Classification System (NAICS), as validated via the SAM. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contractor must be registered on the SAM located at http://www.sam.gov. General Capabilities Statements will not be accepted. Please submit detailed responses (e.g., not standard marketing materials and general capability statements) that meet the RFI objectives. The goal of the RFI responses is compile an enhanced understanding of strategic inputs. Product capability statements are not being sought. Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Answer all questions that are relevant or most meaningful to your organization’s operations. Please denote questions that are not applicable or intentionally skipped. The page limit is not to exceed 7 pages. Responses should be single-spaced in Times New Roman 12-point font. Specify whether these responses are for USG access only by writing “[For US Government Use Only]” at end of response. Please submit your final responses to this RFI no later than by 5:00 PM ET on 11/13/2023. Submit responses electronically, with subject “Clinical Data on Residents of Long-Term Care Facilities to Support CDC Programs and Emergency Response: [Company Name]” All information received in response to the RFI that is marked as proprietary will be handled accordingly. Email responses to Matt Guajardo at mguajardo@cdc.gov.