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{{Sepsis}} | {{Sepsis}} | ||
{{CMG}} | {{CMG}}{{RGB}} | ||
{{SK}} sepsis syndrome; septic shock; septicemia | {{SK}} sepsis syndrome; septic shock; septicemia | ||
==Overview== | ==Overview== | ||
Mandatory reporting of sepsis quality measures | |||
Several entities have instituted [[Patient_safety#Mandatory_reporting | mandatory reporting]] in their jurisdictions. These efforts are consistent with prior recommendations by the [[Academy of Medicine]] for mandatory reporting<ref>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/</ref>. | |||
{| class="wikitable" | |||
! style="text-align: center; font-weight:bold; background-color:#c0c0c0;" | Program, owner, and year of implementation | |||
! style="text-align: center; font-weight:bold; background-color:#c0c0c0;" | Method | |||
! style="text-align: center; font-weight:bold; background-color:#c0c0c0;" | Impact | |||
! style="font-weight:bold; background-color:#c0c0c0;" | Comments | |||
|- | |||
| style="text-align: center;" | SEP-1<br/> | |||
[[Centers for Medicare and Medicaid Services]]<br/> | |||
10/01/2015 | |||
| style="text-align: center;" | Public reporting at Medicare's [https://www.medicare.gov/hospitalcompare/about/timely-effective-care.html Hospital Compare website] | |||
| Not studied | |||
| Complex and time-consuming for hospitals to collect data<ref name="pmid27294338"/> | |||
|- | |||
| style="text-align: center;" | Bundled Payments for Care Improvement (BPCI)<ref name="BPCI"/><br/> | |||
[[Centers for Medicare and Medicaid Services]]<br/> | |||
2013 | |||
| style="text-align: center;" | Voluntary | |||
Financial incentives | |||
|No benefit after the first year of implementation<ref name="pmid30021090"/> | |||
| | |||
|- | |||
| style="text-align: center;" | Rory's Regulations<br/> | |||
State of New York<ref name="rory"/><br/> | |||
2013 | |||
| style="text-align: center;" | 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<ref name="pmid31310298"/> | |||
| Based on older SEPSIS-2<ref name="pmid12664219"/> | |||
|- | |||
| colspan="4" | Notes: | |||
|} | |||
==Federal reporting== | |||
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<ref name="pmid25167590">{{cite journal| author=Centers for Medicare and Medicaid Services (CMS), HHS| title=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. | journal=Fed Regist | year= 2014 | volume= 79 | issue= 163 | pages= 49853-50536 | pmid=25167590 | doi= | pmc= | url=https://www.federalregister.gov/documents/2014/08/22/2014-18545/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the }} </ref><ref name="pmid25291572">{{cite journal| author=Cooke CR, Iwashyna TJ| title=Sepsis mandates: improving inpatient care while advancing quality improvement. | journal=JAMA | year= 2014 | volume= 312 | issue= 14 | pages= 1397-8 | pmid=25291572 | doi=10.1001/jama.2014.11350 | pmc=4813658 | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=25291572 }} </ref><ref name="pmid27294338">{{cite journal| author=Klompas M, Rhee C| title=The CMS Sepsis Mandate: Right Disease, Wrong Measure. | journal=Ann Intern Med | year= 2016 | volume= 165 | issue= 7 | pages= 517-518 | pmid=27294338 | doi=10.7326/M16-0588 | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=27294338 }} </ref>. Variations in hospital mortality contributed to the rationale for SEP-1<ref name="pmid30024430">{{cite journal| author=Hatfield KM, Dantes RB, Baggs J, Sapiano MRP, Fiore AE, Jernigan JA et al.| title=Assessing Variability in Hospital-Level Mortality Among U.S. Medicare Beneficiaries With Hospitalizations for Severe Sepsis and Septic Shock. | journal=Crit Care Med | year= 2018 | volume= 46 | issue= 11 | pages= 1753-1760 | pmid=30024430 | doi=10.1097/CCM.0000000000003324 | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=30024430 }} </ref>. As of 2017, 87% of eligible hospitals reported compliance measures with variation in rates of compliance<ref name="pmid30585827">{{cite journal| author=Barbash IJ, Davis B, Kahn JM| title=National Performance on the Medicare SEP-1 Sepsis Quality Measure. | journal=Crit Care Med | year= 2019 | volume= 47 | issue= 8 | pages= 1026-1032 | pmid=30585827 | doi=10.1097/CCM.0000000000003613 | pmc=6588513 | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=30585827 }} </ref>. | |||
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<ref name="pmid27294338">{{cite journal| author=Klompas M, Rhee C| title=The CMS Sepsis Mandate: Right Disease, Wrong Measure. | journal=Ann Intern Med | year= 2016 | volume= 165 | issue= 7 | pages= 517-518 | pmid=27294338 | doi=10.7326/M16-0588 | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=27294338 }} </ref>. 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<ref name="pmid27294338"/>. As an example, abstractions of clinical charts usually disagree over determining "time zero"<ref name="pmid29932042">{{cite journal| author=Rhee C, Brown SR, Jones TM, O'Brien C, Pande A, Hamad Y et al.| title=Variability in determining sepsis time zero and bundle compliance rates for the centers for medicare and medicaid services SEP-1 measure. | journal=Infect Control Hosp Epidemiol | year= 2018 | volume= 39 | issue= 8 | pages= 994-996 | pmid=29932042 | doi=10.1017/ice.2018.134 | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=29932042 }} </ref>. | |||
Related is the voluntary Bundled Payments for Care Improvement (BPCI) initiative in 2013<ref name="BPCI">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)</ref>. After the first 9 months of the BPCI, 88 of 2918 eligible hospitals participated in BPCI for sepsis<ref name="pmid30021090">{{cite journal| author=Joynt Maddox KE, Orav EJ, Zheng J, Epstein AM| title=Evaluation of Medicare's Bundled Payments Initiative for Medical Conditions. | journal=N Engl J Med | year= 2018 | volume= 379 | issue= 3 | pages= 260-269 | pmid=30021090 | doi=10.1056/NEJMsa1801569 | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=30021090 }} </ref>. No difference was found in the quality or costs of sepsis care<ref name="pmid30021090"/>. | |||
==New York state reporting== | |||
In 2013, the New York State Department of Health (NYSDOH) began mandatory state-wide reporting of quality measures (Rory's Regulations)<ref name="rory">10 CRR-NY 405.4. Westlaw. Thomson Reuters [accessed 2019 Aug 13]. Available from: https://govt.westlaw.com/nycrr/Document/I4fe39657cd1711dda432a117e6e0f345 </ref><ref>Rory’s Regulations. Available at https://rorystauntonfoundationforsepsis.org/rorys-regulations-full-legal-document/</ref><ref name="pmid30189749">{{cite journal| author=Levy MM, Gesten FC, Phillips GS, Terry KM, Seymour CW, Prescott HC et al.| title=Mortality Changes Associated with Mandated Public Reporting for Sepsis. The Results of the New York State Initiative. | journal=Am J Respir Crit Care Med | year= 2018 | volume= 198 | issue= 11 | pages= 1406-1412 | pmid=30189749 | doi=10.1164/rccm.201712-2545OC | pmc=6290949 | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=30189749 }} </ref>. This was in part due to the death in 2012 of Rory Staunton. Implementation was based on SEPSIS-2<ref name="pmid12664219">{{cite journal| author=Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D et al.| title=2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. | journal=Intensive Care Med | year= 2003 | volume= 29 | issue= 4 | pages= 530-8 | pmid=12664219 | doi=10.1007/s00134-003-1662-x | pmc= | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=12664219 }} </ref>. Subsequent reduction in mortality was associated with increased compliance to process measures<ref name="pmid30189749"/>. 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<ref name="pmid28528569">{{cite journal| author=Seymour CW, Gesten F, Prescott HC, Friedrich ME, Iwashyna TJ, Phillips GS et al.| title=Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. | journal=N Engl J Med | year= 2017 | volume= 376 | issue= 23 | pages= 2235-2244 | pmid=28528569 | doi=10.1056/NEJMoa1703058 | pmc=5538258 | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=28528569 }} </ref>. | |||
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<ref name="pmid31310298">{{cite journal| author=Kahn JM, Davis BS, Yabes JG, Chang CH, Chong DH, Hershey TB et al.| title=Association Between State-Mandated Protocolized Sepsis Care and In-hospital Mortality Among Adults With Sepsis. | journal=JAMA | year= 2019 | volume= 322 | issue= 3 | pages= 240-250 | pmid=31310298 | doi=10.1001/jama.2019.9021 | pmc=6635905 | url=https://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=31310298 }} </ref>. | |||
==References== | ==References== | ||
Latest revision as of 23:03, 21 April 2020
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Risk calculators and risk factors for Sepsis mandatory reporting |
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
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 |
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] |
Voluntary
Financial incentives |
No benefit after the first year of implementation[4] | |
| Rory's Regulations State of New York[5] |
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
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
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
- ↑ 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/
- ↑ 2.0 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.
- ↑ 3.0 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)
- ↑ 4.0 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.
- ↑ 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
- ↑ 6.0 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. - ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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.
- ↑ 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. - ↑ 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.
- ↑ Rory’s Regulations. Available at https://rorystauntonfoundationforsepsis.org/rorys-regulations-full-legal-document/
- ↑ 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.
- ↑ 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.