The Continuation of the Quality and Safety Review System (QSRS) Data Analysis

This is a Small Business Sources Sought notice (SBSS). This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small business; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 1. Project Description and Requirements: The Institute of Medicine report, To Err Is Human, revealed more than 15 years ago the extent of medical errors that occur in U.S. hospitals. Safety experts—including AHRQ, the Centers for Medicare & Medicaid Services (CMS), and other Federal partners—realized that hospitals needed to understand specifically how and where adverse events were occurring in order to prevent them. In response to this challenge, CMS created the Medicare Patient Safety Monitoring System (MPSMS) to measure the magnitude of adverse events among hospital patients covered by Medicare and to create a baseline to assess the impact of national patient safety initiatives. The MPSMS was transferred to AHRQ in 2009. This chart review-based surveillance system determined national rates for 21 types of adverse events, including certain hospital-acquired conditions (HACs), such as postsurgical complications and pressure ulcers but has some limitations that AHRQ is addressing with a new surveillance system. In 2012, AHRQ began developing the Quality and Safety Review System, known as QSRS, to replace MPSMS. The QSRS was developed, tested, and enhanced, and in 2020 it replaced the MPSMS. QSRS is an expandable and multi-functional software platform that is designed to detect adverse events from a sample of inpatient hospital medical records, calculate rates of adverse events, and provide detailed information about those adverse events. Utilizing AHRQ’s Common Formats for Surveillance (https://www.psoppc.org/psoppc_web/publicpages/surveillancecommonformats) as the specification for data collection, QSRS uses standardized definitions and algorithms to ensure an adverse event identified at one locality is the same as an adverse event identified elsewhere. QSRS data are collected through retrospective manual abstraction of inpatient records. Human abstractors answer questions to identify whether an adverse event occurred during a particular hospital stay. Overall, the QSRS will generate adverse event rates and trend performance over time. This primary purpose of this project is to analyze data that QSRS produces. These analyses fulfill multiple objectives: (1) The analysis directly contributes to developing the National Hospital Acquired Condition (HAC) report; (2) The analysis supports enhancement and operation of QSRS; and (3) The analysis of special studies provides evidence of patient safety and quality of care status of hospitals in the United States. Tasks include: Task 1.1 Analyze QSRS Data and Produce adverse event (AE) Rates. The Government will provide to the Contractor patient-identified abstracted data from the Centers for Medicare & Medicaid Services (CMS) Clinical Data Abstraction Center (CDAC) for analysis to detect AEs, as identified from medical records acquired through the existing CMS Quality Programs or related initiatives. Currently, the CY sample consists of approximately 26,400 Medicare charts. The contractor shall analyze the data and provide the findings. These findings include, but not limited to, the AE and patients at risk counts, rates, and confidence interval of rates. There are total of 35 specific AE measures and a composite measure in the analysis. Task 1.2 Compare rates with the previous year. The contractor shall compare the available data for the two most recently abstracted calendar year data. The comparisons will be made for all the 35 AE measures. Task 1.3 Analyze QSRS data to produce AE rates in support of the National HAC rate. The Contractor shall analyze QSRS data furnished by the Government to produce summary adverse event rates in specific areas. The analysis shall include two different composite rates and breakdown of these rates into 35 specific AE measures. Each of these rates shall be broken down into five different hospital types. Task 1.4 Develop and Implement a risk adjustment method for QSRS data. The Contractor shall develop a method that risk adjusts for key patient characteristics and key hospital characteristics. The development of this risk adjustment method will be based on previously established protocol and new information available from data abstraction and sampling plan. The risk adjustment method shall be applied to the QSRS data and risk-adjusted rates shall be produced for composite and specific AE rates described in tasks 1.1 and 1.3. Task 1.5 (Monthly) Quality Assurance of QSRS data and HAC rates. The contractor shall continue generating monthly HAC rates inherited from previous contract work. The Government will furnish the Contractor with the SAS programming of the quality assurance process. Following award, and after submitting complete and accurate personnel applications and security documentation, the Contractor shall be provided access to the monthly data of CY 2023. The monthly (and potentially weekly) control charts shall be produced each month in a continuous basis for the composite and specific AE measures. Task 1.6 Special Analyses/Study of QSRS Data. The Contractor shall prepare two reports on a special analysis of QSRS data based on available CY data as agreed upon between the COR and the contractor. For example, a study could compare adverse events pre-, during, and post- COVID, depicting the trends. The contractor shall design the study and analyze the data, develop reports, and prepare a manuscript for publication. Task 1.7 Develop and implement a process for AE measure-specific documentation and standardization. The contractor shall develop and implement a process to ensure AE measure-specific descriptions accurately reflect the needs and expectations of QSRS stakeholders (including, but not limited to, AHRQ, CMS, and the Common Formats Expert Panel convened by the Patient Safety Organizations Privacy Protection Center). Applying various methods, the contractor shall develop for each measure a clinical rationale, numerator and denominator statements, operational definition, and recommend necessary modifications to the current AE descriptions. Task 1.8 Analysis in support of determining weights of sample strata. The contractor shall utilize an existing method to determine the weight of each sample stratum of the sample. The Contractor shall implement the process in SAS programming. The Government will provide the contractor with previously developed method(s). Task 1.9 Activities in Support of Potentially Revising or Enhancing QSRS Measures. Based on direction from the COR, or COR-approved suggestions from the Contractor for appropriate areas of focus, the Contractor shall perform analyses in support of necessary ad hoc modifications or updates of QSRS abstractor instructions (including software help text) and/or AE measures including necessary changes to the algorithms. Examples of potential modifications would be those necessary to correct errors in the measures that have been identified as being associated with QSRS adverse events being under-counted (false negatives) or over-counted (false positives) based on the existing adverse event descriptions. Task 1.10. Develop and implement a process to ensure validity, reliability, and accuracy of the measures. The contractor shall review literature, consult with peers, gather evidence, and perform necessary analyses to develop the validity, reliability, and accuracy methods (or techniques) and implement these methods as part of the backend data analysis (in SAS or similar statistical programming). Task 1.11. Track and trend QSRS data. The Contractor shall develop and implement the methods developed in the base period to allow risk-adjusted trends based on QSRS adverse events to be tracked from available CY data as agreed between the COR and the contractor. Task 1.12 Additional Special Analyses/Study of MPSMS Data. The Contractor shall prepare and deliver to the COR one to two reports on special analyses of MPSMS data. This study should be performed so that they can serve as the basis for a paper to be submitted for publication in a peer-reviewed scientific journal. Task 1.13 Develop a methodology to determine weights of sample strata. The contractor shall develop a method to determine weight of each sample stratum of the sample. The Contractor shall implement the process in SAS programming. The Government will provide the contractor with previously developed method(s). The contractor may base the development of sampling weight determination method on the previously developed method(s). CORE COMPETENCIES – the following competencies are required for this project: The core competencies required for QSRS data analysis for HAC reporting include statistical programming for data analysis, reporting the analysis that includes descriptive and inferential statistics along with charts and tables, and clinically interpreting findings. The core competencies required for supporting QSRS enhancement and operation of QSRS system include reviewing patient records and drawing conclusions, reviewing AHRQ Common Formats for Surveillance documents for clinical interpretation and necessary modifications, reviewing QSRS abstraction help text and algorithms for necessary modifications, developing and running distinct statistical programming for quality assurance of QSRS data, risk adjustment, and sample strata weight determination. The core competencies required for special studies include designing and conducting the special studies, developing and running distinct statistical programming, connecting databases of various sources, and writing reports and manuscripts for publication in the top-tier medical journals. CAPABILITY CRITERIA – Capabilities will be reviewed based on the following criteria: History of key personnel having prior experience as a team in core competencies. Key personnel must include physician(s), nurse(s), and statistician(s)/data analyst(s) along with expertise in public health, pharmacy, epidemiology, and project management. The key personnel must have thorough understanding of (i) AHRQ Common Formats for Surveillance, (ii) QSRS algorithms used for data analysis, and (iii) QSRS help text for chart abstraction. The key personnel must be knowledgeable about CMS/AHRQ Medicare Patient Safety Monitoring System (MPSMS). The key personnel must have a thorough understanding of AHRQ and its current contractor’s publications on MPSMS. Proof of having necessary information technology (IT) resources to securely store and transmit information containing personal identifiable information (PII) and protected health information (PHI). Proof of having necessary statistical and other software that can perform all necessary statistical analyses for the tasks described in the SOW. Demonstrated physician and nurse expertise and experience in (i) patient chart review, (ii) health services research including secondary data analysis studies, and (iii) serving as the primary author and/or co-author of manuscripts published in top-tier medical journals. Demonstrated physician and nurse experience in providing clinical interpretation of analyzed data. Demonstrated physician and nurse experience in providing clinical expertise in development of IT solutions. Demonstrated statistician/data analyst expertise and experience in developing special statistical programming for (i) measures of association including modeling techniques and linking various models, (ii) risk adjustment for patient and hospital characteristics, (iii) determination of sample strata weights, and (iv) various control charts for quality assurance of the data. 2. Anticipated period of performance: The period of performance for this project is a base period of 12 months with 4, one year options. 3. Other important considerations: N/A 4. Information Sought: The tailored response to this Small Business Sources Sought notice should describe the requested information below. Respondents must provide, as part of their response, information concerning: a) Staff expertise, including their availability, experience, and formal and other training; b) Current in-house capability and capacity to perform the work; c) Corporate experience and management capability; d) Prior completed projects of similar size; and e) Examples of prior completed Government contracts, references, and other related information. Contractors must describe their capacity and experience as it relates to the project requirements (including CORE COMPETENCIES and CAPABILITY CRITERIA) described above. 5. Information Submission Instructions Interested qualified small business organizations should submit a tailored capability statement for this requirement. The cover page must include the following: UEI number Organization name Organization address Size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to NAICS code 541611 Technical point(s) of contact, including names, titles, addresses, telephone, and e-mail addresses. Any applicable Governmentwide Acquisition Contracting (GWAC) vehicle information (example: GSA Schedule and SIN) All Capability Statements sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to David Goodno, Contract Specialist, [email protected] in MS Word, or Adobe Portable Document Format (PDF), no later than 10:00 AM, January 19, 2023, the subject line shall read: “Sources Sought Notice HHS-AHRQ-SBSS-23-10002 (QSRS Data Analysis)”. Responses should not exceed 15 single-sided pages (including the cover page, all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. 6. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses to this notice will not be considered adequate responses to a solicitation. 7. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).