CMS Alignment FAQ's

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Case inclusion

Q: There are times when CMS reporting criteria is not met for a severe sepsis or septic shock case. Are we to report these cases to the NYSDOH portal?

A: Yes. The denominator for the NYSDOH data submission still requires reporting ALL cases of severe sepsis or septic shock INCLUDING cases identified through coding AND/OR other avenues (e.g., concurrent case identification; retrospective review; and so forth). Hospitals are NOT to be using the CMS method of selecting cases and adding DOH data elements to those cases. This would be an incorrect interpretation of the 2017 modification; the NYSDOH requires reporting ALL severe sepsis and septic shock cases regardless of how they are identified, even if they do not meet CMS reporting requirements.

Q: CMS has excluded transfers in from acute care facilities. Is NYS also excluding these cases? If not, will we be able to report on treatment provided at the transferring hospital?

A: The Department is still requiring to report transfer cases (i.e., any admission with severe sepsis or septic shock must be reported). For a few select adherence variables, treatment prior to arrival at your facility may be reported in your data capture. You must follow CMS specifications INCLUDING the requirement to have the medical record documentation in YOUR medical record to support data reporting. Examples are provided in the initial pages of the NYSDOH Data Dictionary v4.1.

Q: If we have a case that does not meet CMS reporting requirements but does meet NYSDOH reporting requirements, what do we use for severe sepsis presentation time or septic shock presentation time? The patient has severe sepsis but has fallen out of CMS reporting.

A: All cases of severe sepsis or septic shock are to be reported to the NYSDOH portal even if they fall out of CMS reporting requirements. In these instances, there will still be clinical documentation that confirms severe sepsis or septic shock. The datetime associated with this clinical confirmation should be reported as the start time.

Q: If a patient is not actually diagnosed for severe sepsis or septic shock, but there is documentation for sepsis, and when abstracting for CMS case meet criteria for severe sepsis, does this case get submitted to NYS?

A: The criteria for reporting cases to the NYSDOH will remain the same as in prior Department reporting. Hospitals are NOT to be using the CMS method of selecting cases and adding DOH data elements to those cases. Only cases of severe sepsis and septic shock are to be reported. Cases of sepsis that do not progress to severe sepsis or septic shock are not to be reported to the NYSDOH.

Q: The CMS-SEP- 1 guidelines for the element severe sepsis present state that viral infections and fungal infections are not acceptable sources of infection. If a viral or fungal source is the only documented source of infection, should these cases be reported?

A: If severe sepsis or shock was part of the patient's final diagnosis (beyond the bacterial vs. viral/fungal infection) then this case would need to be reported to the NYSDOH. All cases of severe sepsis or septic shock are to be reported regardless of the source of infection.

Q: Will those cases from viral or fungal infections be in our denominator?

A: If the clinicians at your facility determined that a patient had severe sepsis or septic shock with only viral/fungal infection source, it would still be in the denominator. The denominator is all severe sepsis/septic shock patients - not all patients with severe sepsis or septic shock except viral/fungal infection sources. That is a filter that CMS chose to apply for infections. However, the NYSDOH did not. So if a clinician determined that a patient has severe sepsis or septic shock and the only source of infection was viral or fungal, it would need to be reported.

Measures

Q: What are the measures now with the revised data dictionary? What is time zero (or start time)?

A: The revision to the measures is currently under development. It is likely that the data will continue to be presented with more than one time zero for the quarterly hospital reports.

Q: Sep-1 is an "all or none" measure. Will the DOH also report this way?

A: The Department will continue to report out individual measures within the bundle to assist hospitals in quality improvement efforts.

Q: CMS requires a repeat lactate within 6 hours if the lactate is > 2. Has the DOH aligned with that or are they still using >4 for the repeat lactate requirement?

A: The Department has not yet released measure details. Therefore, if you repeated your lactate, be sure to report the data in the data collection portal.

Fluids

Q: If there is NO initial hypotension, lactate level is NOT >= 4 mmol/L, and NO documentation of septic shock, would the fluid administration data element be left blank? And if left blank, would the 10 fluid assessment data elements also be left blank?

A: The Adult Crystalloid Fluid Administration data element must be answered (for adult cases). For this data element, if none of the 3 CMS criteria are present (initial hypotension, lactate >= 4mmol/L, or documentation of septic shock), then you would choose option 3 as the answer. The data element must be answered (unless the patient was excluded from the protocol), so option 3 is the most appropriate. Also by choosing option 3, you will not need to answer the fluid assessment data elements.

Q: We provided crystalloid fluids for a patient who did not meet the requirement for fluids (i.e., the patient did not have elevated lactate, hypotension, or septic shock). What is the correct data response? I don’t want to have to assess fluid responsiveness when fluids were not required.

A: The correct response for the NYSDOH data collection is option 3 = (No) Crystalloid fluids were not initiated prior to, at the time of, or after the presentation of Initial Hypotension, Initial Lactate Level Result >=4 mmol/L, or Documentation of Septic Shock, or unable to determine whether or not they were administered. Though you did provide fluids, you did not provide them for the conditions described. Fluid responsiveness data elements would not be required to be completed for option 3 data values.

Q: How is the “Fluid Challenge Performed” data element answered if there is no septic shock and therefore no time of septic shock presentation? Since we do not have septic shock what would the time frame be?

A: If a fluid challenge was not performed, then option "2 = (No) …" would be chosen. This is 1 of 10 fluid assessment data elements that must be answered if Adult Crystalloid Fluid Administration was answered with option "1 = (Yes) ..." If there was no presentation of septic shock, the time window would default to that which begins with completion of fluids and ends 6 hours after severe sepsis presentation.

Q: If a patient has severe sepsis and receives the correct amount of fluids but does not meet the criteria for septic shock -- what would be the appropriate answer for Crystalloid Fluid Administration? And if the answer is ‘yes’ and septic shock present is ‘no,’ would we be required to fill out the fluid assessment data elements?

A: From what you describe in your example scenario, a patient was deemed as having severe sepsis with initial hypotension and thus received the sufficient amount of crystalloid fluids. If so, then you would answer "Yes" for that fluid data element, and the fluid assessment data elements would still need to be answered (yes/no) as being completed or not. These will be required if fluids are reported as given - not just for those with septic shock.

Q: CMS has the one hour post 30 ml/kg bolus as the time period for the assessment for persistent hypotension. Is the DOH planning on hypotension assessment in the one hour post completion of the bolus and not the entire 6 hour window?

A: The assessment of persistent hypotension will be according to CMS specifications.

Q: Since the completion date/time for fluids is no longer required, will the abstractor follow the same guidelines for SEP 1 to determine fluid completion time in order to identify persistent hypotension?

A: The abstraction/reporting of the fluid administration data element will all be according to CMS specifications.

Q: In order to meet the CMS focused exam data element ALL 5 elements under the focused CMS exam have to be documented OR 2 or more elements from hemodynamic monitoring (which includes passive leg raise and bedside echo). Would DOH consider separating them out?

A: The abstraction/reporting of the various fluid assessment data elements will all be according to CMS specifications. Pleases refer to the CMS notes and guidelines. It is possible to provide reporting for each focused exam in quarterly reports, if this is valuable to the provider community.

Timing

Q: How will you handle patients who have all of the sepsis treatments initiated prior to "official" admission? Prior to this, all of the data elements fell out unless date/time was arrival to hospital. Won't that happen with this new guideline?

A: For a few select adherence variables, treatment prior to arrival at your facility may be reported in your data capture. You must follow CMS specifications INCLUDING the requirement to have the medical record documentation in YOUR medical record to support data reporting. Examples are provided in the initial pages of the NYSDOH Data Dictionary v4.1.

Q: With CMS, the date and time of presentation of severe sepsis is based on documentation of severe sepsis or meeting the three criteria, will this apply to DOH determination of presentation of severe sepsis as well?

A: The abstraction/reporting of the severe sepsis presentation data element will all be according to CMS specifications. Please refer to the CMS notes and guidelines.

Please also see above FAQ:

If we have a case that does not meet CMS reporting requirements but does meet NYSDOH reporting requirements, what do we use for severe sepsis presentation time or septic shock presentation time? The patient has severe sepsis but has fallen out of CMS reporting.

All cases of severe sepsis or septic shock are to be reported to the NYSDOH portal even if they fall out of CMS reporting requirements. In these instances, there will still be clinical documentation that confirms severe sepsis or septic shock. The datetime associated with this clinical confirmation should be reported as the start time.

Q: The Antibiotic Administration data element allows a window of “24 hours prior to or 3 hours following” the severe sepsis presentation. However, for the Antibiotic Administration Selection data element, the responses only refer to a time window of “3 hours following” and does not mention “24 hours prior to.” Does this mean that even if an antibiotic was given within that 24 hour window before severe sepsis presentation, we can’t say “Yes” to antibiotic selection?

A: The abstraction/reporting of the severe sepsis presentation data element will all be according to CMS specifications. Please refer to the CMS notes and guidelines.

Q: For Vasopressor Administration, the DOH data dictionary states that this data element must be completed unless the patient was excluded. The time window given by CMS relates to septic shock presentation time. If a patient does not progress to septic shock, our data abstractors don’t have a window with which to complete this element. Therefore, if the patient does not have septic shock, can we leave this field blank?

A: No, the Vasopressor Administration data element cannot be left blank (unless the patient was excluded from the sepsis protocol). If the patient did not progress to septic shock, the time window would default to 6 hours after severe sepsis presentation.

Miscellaneous

Q: Will the DOH align with CMS regarding Lactic acid level and platelet levels as this often causes confusion?

A: The Department will still require that the actual value of the initial lactate be reported, as described in the NYSDOH Data Dictionary v4.1. The platelet data element will remain a severity adjustment variable, and it will require a response as to whether the platelet count at the time presentation of severe sepsis was <150,000 cell/mm3.

Q: Please clarify the point about contaminated blood culture collections as not meeting the requirement as reportable. Clinicians may not know about contamination until days after treatment initiates.

A: Failed attempts or contaminated specimens are not allowed to be reported as "collected" for cases reported to the NYSDOH. This is not meant to affect clinician care - this only applies to the reporting of the quarterly data for the NYSDOH.

Q: If there was no delay in collecting a blood culture, how do I answer the Blood Culture Collection Acceptable Delay? According to the data dictionary, we are required to answer this if Blood Culture Collection = 1.

A: If there was no delay in the collection of a blood culture, then an "acceptable delay" did not occur. If an "acceptable delay" never occurred, then there would naturally be no documentation of any "acceptable delay". Therefore, the option stating "No - there is no documentation supporting an acceptable delay in the collection of a blood culture" would be the appropriate selection if a delay never occurred for a blood culture collection.

Q: Why are there no pediatric recommendations regarding use of vasopressors or persistent hypotension?

A:Recommendations now are to start vasopressors if no response to 3 or more boluses of fluids by 1 hour of presentation.

Q: The Department is very interested in continuing to expand upon pediatric measures as clinically relevant and determined by the medical literature. Re: LIP/MD documentation -- does this mean this documentation does not have to be LIP/MD and the abstractor can assess by any documentation?

A: All instructions regarding acceptable documentation for CMS SEP-1 variables will need to be followed as specified by CMS. For other NYSDOH data elements, please follow the usual abstraction processes as noted in the Data Dictionary v4.1.

Q: If protocol was not initiated for a reason (i.e., an excluded case), does a MD or other LIP have to document this?

A: Yes. If a patient met acceptable exclusion criteria, then documentation of that reason by a physician, advanced practice nurse, or physician assistant will need to be present in the medical records. Hospital sepsis management policies were developed consistent with the initial NYSDOH regulations.

Q: Will policies updated to reflect the CMS SEP-1 and revised NYS DOH variables have to be reviewed and approved by NYS DOH?

A: Yes. Any sepsis protocol with significant changes must be submitted for review at https://ny.sepsis.ipro.org.

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