While I understand some of the frustration associated with the looming CMS Core 
Measure reporting for sepsis, I am stumped by some of the sentiments in the 
post by Dr. Parekh. The organ failures indicative of SEVERE SEPSIS have not 
changed. Relying solely on lactate is not clinically sound. And to clarify, a 
lactate level of > 2.0, not 4.0, is defined as severe sepsis  and >/= 4.0 is 
septic shock. We have all seen pts who, despite being very ill, have normal 
lactate levels. Often it is a  case of sequestered lactate when hypo-perfusion 
is so profound that the levels don't even rise until wash-out is achieved by 
reperfusion. 

Second, I have listened to the arguments against "cook-book" medicine - and one 
could argue that complying with a core measure is such a practice - however the 
overwhelming evidence for the effectiveness of the sepsis bundles is still 
ignored by a large number of clinicians - SHAME ON US that we need an agency 
like CMS to force us to abandon 'practice-based evidence' apply sound 
principles to the care of sepsis pts. 
We have complied with similar guidelines for MI and stroke with good outcomes 
for pts - why not for this disease process that carries such peril. 
I think that the State of NY may have gone too far by creating laws around 
sepsis care, however desperate times........children, nor anyone for that 
matter, should  die as a result of our ignorance nor our egos. 

I will admit that this core measure is extremely complicated - as is the 
disease.  
The specifications describing Time-0 are very complicated - but the fact 
remains that if we recognize severe sepsis early and treat the pt properly in a 
timely fashion, it seems to me that the time requirements will be met. 

I also had hoped for a  step-wise approach to the measure that would begin with 
the severe sepsis bundle and progress to shock care. But the fact is that 
septic shock mortality is still unacceptably high - and often because of 
delayed or omitted care. 

I for one welcome the double-edged sword that is this measure. This is a wild 
ride and I am glad to have a front row seat. 

Namaste, 

MARY ANN BARNES-DALY RN BSN CCRN DC  | Clinical Performance Improvement 
Consultant
Sutter Health - Office of Patient Experience | 2200 River Plaza Drive, 
Sacramento, CA 95833
Mobile 916.200.5604| Office 916.286.6717  | [email protected] 

“You never change things by fighting the existing reality. To change something, 
build a new model that makes the existing model obsolete.”      ~R. Buckminster 
Fuller 

-----Original Message-----
From: Sepsisgroups [mailto:[email protected]] On 
Behalf Of Townsend, Sean, M.D.
Sent: Tuesday, September 15, 2015 11:35 AM
To: Ram Parekh
Cc: Allen, Gilman B; [email protected]
Subject: Re: [Sepsis Groups] Sepsis Core Measures Follow-up

While I appreciate many points of view, I can't engage in a reasoned discussion 
that brings out advantages and disadvantages to certain approaches if we must 
toss terms such as insanity, imposition, nefarious, unacceptable, misuse, and 
disastrous.

It would we useful, I think, to remember that such dialogue has been used since 
the inception of the Surviving Sepsis Campaign's efforts to improve care 14 
years ago, and the proof of the effect of such efforts is that mortality in 
Rivers' control arm was 46% versus 18.8 in ProCESS.

Working together carefully and patiently is an important tenet of our 
improvenent efforts.

As for the remarks below, I would simply note that the approach to antibiotics 
is fully supported in the 2012 SSC Guidelines, and those were endorsed by the 
infectious Disease Society of America.  The standard of broad spectrum 
antibiotics for a disease that carries lethal potential if you guess 
incorrectly is not in dispute.

Finally, the definitions if severe sepsis and shock have not changed.  How one 
*measures* persistent hypotension after fluid administration is the issue.  If 
the author has a measurement strategy to propose, I am certain we can carry 
this forward as a consideration.

On Sep 15, 2015, at 11:03 AM, Ram Parekh 
<[email protected]<mailto:[email protected]>> wrote:

Thank you, Dr. Allen, for speaking up on this insanity that is being imposed on 
hospitals and providers.

I'll add 2 more questions, and one comment.


 *   First, NS and LR are ok, but Isolyte is unacceptable. How is this 
possible? NS may cause harm, as you have already mentioned, and LR may affect 
trending lactates particularly in shock states, yet those are the only CMS 
sanctioned crystalloids, while balanced solutions like Isolyte or Plasmalyte do 
not qualify.

 *   Secondly, on what evidentiary basis and by what rationale have the Severe 
Sepsis and Septic Shock definitions been changed? Infection + 2+ SIRS + lactate 
> 4mmol/L has been been the Severe Sepsis definition since the Rivers EGDT 
trial and was also used in the RCT triumvirate of PROMISE, ARISE, and PROCESS. 
Now, this Severe Sepsis criteria has been subsumed by the 'Septic Shock' 
definition and the new Severe Sepsis definition includes a myriad of end organ 
surrogates such as platelet count and bilirubin level. Again, on what 
evidentiary basis are hospitals and providers being held to this arbitrary 
definition? The best evidence we have to date uses the Rivers definition of 
severe sepsis and septic shock, yet this has been scrapped in favor of a more 
complicated and arbitrary definition. Adding complexity is not in the best 
interest of patient care, if that is indeed the goal.

 *   And last, and most important, is the expectations involving broad spectrum 
antibiotics. This is a more nefarious reincarnation of the disastrous 
antibiotics for pneumonia CMS core measure. The effect this will have on 
antibiotic overuse and misuse will be disastrous.


On Tue, Sep 15, 2015 at 12:25 PM, Allen, Gilman B 
<[email protected]<mailto:[email protected]>> wrote:
Sean,

I attended your webinar on Sepsis Core measures last week and was left with a 
number of concerning questions:

1. If we are using the logic that “there is no evidence to show it doesn’t 
hurt” to justify follow-up physical exam measures for evaluation of response to 
resuscitation, then why does the same logic not apply to the use of Normsol and 
other chloride-balanced crystalloids? I would argue that there is a growing 
body of evidence that normal saline may indeed “hurt” (JAMA. 
2012;308(15):1566-1572.; Br J Surg 102 (1):24-36. Crit Care Med 2014; 
42:1585–1591.

2. In defending the use of many of these unproven metrics of volume 
responsiveness and distal perfusion, you described many of these measures as a 
“proxy” measure of “attentive evaluation” and intensive care.  I full agree, 
and practice this way.  I believe these measures help represent a collective 
epi-phenomenon of intensive and regimented care. Using the same reasoning, why 
then is there no provision in any of this for providers to document their own 
rationale for diverging from some of these restrictive mandates when judged to 
be clinically justified. Is this not also a worthy “proxy” of intensive and 
attentive care?

3. When does the clock really start ticking? Our hospitals still don’t have a 
solid and reliable answer to this question. Is it when the physician documents 
their suspicion of sepsis, 3 hours after a fever and hypotension? When blood 
cultures are first ordered one hour after the fever? Or when an MD orders 
Tylenol, a CBC, lactate, and blood cultures on someone he/she suspects may be 
either bleeding, in pain, or possibly infected post-Op? When do these types of 
patients really “declare” themselves septic.

The efforts to try to “capture” every element of Goal-directed care in an 
“all-or-none” pass/fail algorithm dooms itself from the beginning. Why didn’t 
CMS just start off with the 3 hour bundle, monitor how others do with the 6 
hour bundle, and try to figure out where (and why) their algorithm is 
succeeding, or failing, to capture (and enforce) best practice?

I’ve augured to my group that there is absolutely no excuse for not getting 
blood cultures, a lactate, and fluids on board within one hour of a high 
suspicion of sepsis. This is a low bar we should all be meeting, but probably 
aren’t. Why not simply start there, and work our way forward?

Gilman B. Allen, MD
Associate Professor
Department of Medicine
Director of Adult Critical Care Services University of Vermont / Fletcher Allen 
Healthcare HSRF 220, 149 Beaumont Ave Burlington, VT 05405-0075 
(802)656-9004<tel:%28802%29656-9004>
Fax: (802) 656-8926<tel:%28802%29%20656-8926>
[email protected]<mailto:[email protected]>

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