Sepsis mandatory reporting

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]Robert G. Badgett, M.D.[2]

Synonyms and keywords: sepsis syndrome; septic shock; septicemia

## Overview

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Several entities have instituted  mandatory reporting in their jurisdictions. These efforts are consistent with prior recommendations by the Academy of Medicine for mandatory reporting[1].

Program, owner, and year of implementation  | Method  | Impact  | Comments

|
|
|

SEP-1

Centers for Medicare and Medicaid Services
10/01/2015

| Public reporting at Medicare's Hospital Compare website | Not studied  | Complex and time-consuming for hospitals to collect data[2]
Bundled Payments for Care Improvement (BPCI)[3]

Centers for Medicare and Medicaid Services
2013

| Voluntary

Financial incentives

| No benefit after the first year of implementation[4] |
Rory's Regulations

State of New York[5]
2013

| Mandatory by law  | Reduced mortality as compared to controlled states. Approximately half of patients in control states were accrued after announcement of plans for SEP-1 but all patients were included before implementation of SEP-1[6] | Based on older SEPSIS-2[7]
Notes:

## Federal reporting

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Mandatory reporting of sepsis quality measures, "SEP-1" by Centers for Medicare and Medicaid Services was announced 08/2014 and implemented in 10/01/2015 as a value based purchase with the possibility of financial penalties[8][9][2]. Variations in hospital mortality contributed to the rationale for SEP-1[10]. As of 2017, 87% of eligible hospitals reported compliance measures with variation in rates of compliance[11].

Concerns about the reporting is the complexity of determining compliance as the documentation for chart reviews if 120 pages and may require 2-3 hours per chart to review[2]. The SEP-1 rule has been criticized for focusing on processes of care that are hard to measure rather than more easily measured rates and outcomes[2]. As an example, abstractions of clinical charts usually disagree over determining "time zero"[12].

Related is the voluntary Bundled Payments for Care Improvement (BPCI) initiative in 2013[3]. After the first 9 months of the BPCI, 88 of 2918 eligible hospitals participated in BPCI for sepsis[4]. No difference was found in the quality or costs of sepsis care[4].

## New York state reporting

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In 2013, the New York State Department of Health (NYSDOH) began mandatory state-wide reporting of quality measures (Rory's Regulations)[5][13][14]. This was in part due to the death in 2012 of Rory Staunton. Implementation was based on SEPSIS-2[7]. Subsequent reduction in mortality was associated with increased compliance to process measures[14]. The benefit may be specifically linked to speed of antibiotic administration; however, study of fluids examined when fluids were finished and not when fluids were started[15].

In a controlled study, the improvement of care in New York exceeded the improvement in control states that were only under the influence of CMS pressure[6].

## References

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1. ↑ Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. 5, Error Reporting Systems. Available from: https://www.ncbi.nlm.nih.gov/books/NBK225170/
2. ↑ 2.0 2.1 2.2 2.3 Klompas M, Rhee C (2016). "The CMS Sepsis Mandate: Right Disease, Wrong Measure". Ann Intern Med. 165 (7): 517–518. doi:10.7326/M16-0588. PMID 27294338.
3. ↑ 3.0 3.1 Bundled Payments for Care Improvement (BPCI) initiative: general information. Baltimore: Centers for Medicare and Medicaid Services, 2017 (http://innovation.cms.gov/initiatives/bundled-payments/opens in new tab)
4. ↑ 4.0 4.1 4.2 Joynt Maddox KE, Orav EJ, Zheng J, Epstein AM (2018). "Evaluation of Medicare's Bundled Payments Initiative for Medical Conditions". N Engl J Med. 379 (3): 260–269. doi:10.1056/NEJMsa1801569. PMID 30021090.CS1 maint: Multiple names: authors list (link)
5. ↑ 5.0 5.1 10 CRR-NY 405.4. Westlaw. Thomson Reuters [accessed 2019 Aug 13]. Available from: https://govt.westlaw.com/nycrr/Document/I4fe39657cd1711dda432a117e6e0f345
6. ↑ 6.0 6.1 Kahn JM, Davis BS, Yabes JG, Chang CH, Chong DH, Hershey TB; et al. (2019). "Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis". JAMA. 322 (3): 240–250. doi:10.1001/jama.2019.9021. PMC 6635905 Check `|pmc=` value (help). PMID 31310298.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)
7. ↑ 7.0 7.1 Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D; et al. (2003). "2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference". Intensive Care Med. 29 (4): 530–8. doi:10.1007/s00134-003-1662-x. PMID 12664219.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)
8. ↑ Centers for Medicare and Medicaid Services (CMS), HHS (2014). "Medicare program; hospital inpatient prospective payment systems for acute care hospitals and the long-term care hospital prospective payment system and fiscal year 2015 rates; quality reporting requirements for specific providers; reasonable compensation equivalents for physician services in excluded hospitals and certain teaching hospitals; provider administrative appeals and judicial review; enforcement provisions for organ transplant centers; and electronic health record (EHR) incentive program. Final rule". Fed Regist. 79 (163): 49853–50536. PMID 25167590.
9. ↑ Cooke CR, Iwashyna TJ (2014). "Sepsis mandates: improving inpatient care while advancing quality improvement". JAMA. 312 (14): 1397–8. doi:10.1001/jama.2014.11350. PMC 4813658. PMID 25291572.
10. ↑ Hatfield KM, Dantes RB, Baggs J, Sapiano MRP, Fiore AE, Jernigan JA; et al. (2018). "Assessing Variability in Hospital-Level Mortality Among U.S. Medicare Beneficiaries With Hospitalizations for Severe Sepsis and Septic Shock". Crit Care Med. 46 (11): 1753–1760. doi:10.1097/CCM.0000000000003324. PMID 30024430.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)
11. ↑ Barbash IJ, Davis B, Kahn JM (2019). "National Performance on the Medicare SEP-1 Sepsis Quality Measure". Crit Care Med. 47 (8): 1026–1032. doi:10.1097/CCM.0000000000003613. PMC 6588513 Check `|pmc=` value (help). PMID 30585827.CS1 maint: Multiple names: authors list (link)
12. ↑ Rhee C, Brown SR, Jones TM, O'Brien C, Pande A, Hamad Y; et al. (2018). "Variability in determining sepsis time zero and bundle compliance rates for the centers for medicare and medicaid services SEP-1 measure". Infect Control Hosp Epidemiol. 39 (8): 994–996. doi:10.1017/ice.2018.134. PMID 29932042.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)
13. ↑ Rory’s Regulations. Available at https://rorystauntonfoundationforsepsis.org/rorys-regulations-full-legal-document/
14. ↑ 14.0 14.1 Levy MM, Gesten FC, Phillips GS, Terry KM, Seymour CW, Prescott HC; et al. (2018). "Mortality Changes Associated with Mandated Public Reporting for Sepsis. The Results of the New York State Initiative". Am J Respir Crit Care Med. 198 (11): 1406–1412. doi:10.1164/rccm.201712-2545OC. PMC 6290949. PMID 30189749.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)
15. ↑ Seymour CW, Gesten F, Prescott HC, Friedrich ME, Iwashyna TJ, Phillips GS; et al. (2017). "Time to Treatment and Mortality during Mandated Emergency Care for Sepsis". N Engl J Med. 376 (23): 2235–2244. doi:10.1056/NEJMoa1703058. PMC 5538258. PMID 28528569.CS1 maint: Explicit use of et al. (link) CS1 maint: Multiple names: authors list (link)

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