Exclusion/Exclude Explain

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Please clarify the exclusion of newborn/infant in the NICU who was not previously discharged from initial hospital stay.
Go to https://ny.sepsis.ipro.org/ and on the left side of the screen under "documents" there is a protocol guide and the exclusions are listed on pages 7-8. It is not necessary to login to the site to download these materials.

Do we collect data on patients excluded from the protocol?
Yes. If any of the adherence elements were applied the data would be collected. In addition, all demographic, co-morbidity, and severity variables would be reported.

Regarding fluids, when a patient has renal failure or heart failure and we cannot give 30 ml/kg what do we do? In institutions not following invasive protocol we cannot perform 6 hour bundle - does this reflect as non-compliance?
Several 'Clinical Contraindications' are present in the data dictionary related to IV or IO fluids. If the patient meets one of these criteria that exclude his/her from being treated according to your institution's severe sepsis/septic shock protocol, you should still record data for any components of the protocol they may have received. In addition, all demographic, co- morbidity, and severity variables would be reported. These patients will be included in all outcome measures. The Department has not yet determined whether they will or will not be included in adherence measures.

If patient has a DNR, is the case excluded? Do we need to submit any data on the case?

If the patient has advanced directives or a DNR in place prior to (or at) the development of severe sepsis or septic shock that preclude one or more elements of the protocol then the protocol is not reported. All demographic, severity, and co-morbidity data elements are still required to be reported for the patient.

Regarding clinical contraindications and protocol exclusions:

  • Does the chart have to have a written statement that the "the patient has end stage renal disease or congestive heart failure and is excluded from the sepsis protocol?"
  • If the patient is a known hemodialysis patient, would they then be excluded based on history?
  • If the chart shows that the patient is in decompensated heart failure, could I exclude this patient? Of course, I would still enter all interventions and results that were done during the course.
  • If it is a written statement that is required, could it be documented in the discharge summary or does it need to be during the window?


Several 'Clinical Contraindications' are present in the data dictionary. If the patient meets one of these criteria and there was clear documentation in the record at the time of treatment for severe sepsis/septic shock that they were excluded from your institution's protocol as a result of this contraindication, you should document that contraindication in this section. However any other protocol interventions that were applied should be documented in appropriate sections and all demographic, co-morbidity, and severity variables would be reported.

If a patient meets criteria for more than one exclusion i.e., 'Interventions clinically contraindicated' and 'Patient has advanced directives in place that precluded one or more elements of the protocol', which exclusion should be reported.
The Data Dictionary (Version 1.41) has been modified to permit reporting more than a single exclusion.

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