Focusing on the Goals of Sepsis Treatment: Early GOAL Directed Therapy

Recently CMS released a new guideline on Sepsis benchmarks, called SEP-1. The protocol calls for resuscitation with fluids and antibiotics and blood cultures and serial lactates if the patient has "severe sepsis" or "septic shock" but not "sepsis" alone (sirs plus suspected source). The deep dive into this guideline is reproduced below, for the purpose of highlighting that to be excluded the patient must have a specific order for "comfort care". A better deep dive is here  and here. 

 Now anyone who knows anything about CMS and medical review knows that if you write the words "comfort care" on the chart, the patient does not qualify for inpatient status unless they are on hospice, and that is not a benefit that can be elected in the 3-6 hour time period by an altered septic patient who cannot make decisions, and the hospital cannot admit them unless they are admitted to a hospice program through the hospice itself. Further, unless I am mistaken,  SEP-1 does not include "altered mental status" as evidence of 'end organ dysfunction" and medical delirium is common in patients with severe sepsis and septic shock. These patients are not good decision-makers. I reiterate that the words "comfort care" are not reimbursed for inpatient status as medically necessary. Medicare is a defined benefit plan that denies payments for non medically necessary patient convenience or comfort. 

From the reimbursement perspective, hospitals cannot bill inpatient claims for patients who are "comfort care". Patients who do not meet expectation of surviving beyond two midnights under the Medicare two midnight rules must be placed in observation, unless there is a reasonable expectation that they would survive more than two midnights and require medically necessary care. Palliative treatment in the inpatient setting for sepsis would be such a condition, only if the patient is reasonably expected to survive on admission, and with a near 40% mortality for sepsis, this is a big question. However, if this is the case, the treatment would be palliative, and therefore it would not for example be wise to give a 30 ml/kg bolus to a patient with an EF of 15% who has severe sepsis who does not want positive pressure ventilation or intubation. What is concerning is what the medical review criteria for auditors would be for these patients now that CMS has benchmarked the standard of care for patients with severe sepsis or septic shock and whether that gives ammunition to recovery audit contractors to deny claims. Further, these patients, DNR/DNI but not hospice, will apparently be quality and value based purchasing fallouts for the hospital UNLESS they have a comfort care order on the chart. This will have a hospital payment penalty in the not too distant future.  

The available data from the PROCESS , ARISE and  PROMISE studies do nothing to assist in answering the plight of the septic patient who needs palliative care and is not a candidate for aggressive resuscitation. These patients were all excluded from these trials. Recently, Ashley Shreves highlighted the question of what is a good death here and here. 

It is obvious that a delirious death from sepsis is not a good death, whether it is associated with EGDT or not. I would hope we would focus more on addressing the care of these patients whom we know will likely die and focus on the GOALS of end of life care for these patients as THERAPY. Unfortunately, with this new SEP-1 benchmark I am afraid there will be a push to really push patients into two different black and white groups, either full code with EGDT and SEP-1 benchmark, or comfort care. This push will come from hospitals who will be under payment pressure for meeting standards of care. There will be another push when patients who then have the "comfort care" order are denied from inpatient status and the claims will trend to observation care for patients not expected to survive two midnights and not on hospice. This will result in increased patient financial obligations and lack of effective palliative care for critically ill patients who are too sick to go home and not expected to die imminently in the Emergency Department unless the Emergency and Critical Care community is vocal in voicing our concerns on this issue to CMS. CMS must reform the way that patient needs are met at the end of life and how the payments to hospitals and providers are structured to match the care that is delivered, whether in hospital or out of hospital. 

CMS SEP-1 Guideline

Sepsis from CMS point of view is defined as SIRS plus suspected or documented infection, severe sepsis indicates some element of tissue hypoperfusion or end organ dysfunction and septic shock indicates the presence of a shock state (inadequate delivery of metabolites to meet tissue demand) as defined by failure of resuscitation with crystalloids. http://epmonthly.com/article/understanding-the-new-sep-1-sepsis-rollout/

The specific definition of severe sepsis for CMS purposes goes by certain criteria, notably not including “altered mental status” as a measure of end organ dysfunction and the specific criteria are a little different than what is noted in some trials. These are the definitions in the 2012 SCCM guidelines.

https://www.sccm.org/Documents/SSC-Guidelines.pdf

3 Hour and 6 Hour Benchmarks for Severe Sepsis and Septic Shock

The new CMS guideline for sepsis, termed SEP-1, calls for basic care elements within the first 3 hours of presentation of a patient with severe sepsis or septic shock, (each category having their own 3 hour and 6 hour clocks), but the time stamps and benchmarks do NOT apply to patients with sepsis only (they are in the denominator).

1. 1. draw lactate
2. 2. draw blood cultures
3. 3. administer antibiotics before 3 hours,
4. 4. if initial lactate is elevated above the lab reference, or there is hypotension to give a 30ml/kg crystalloid bolus before 3 hours.

This clock starts from the time that there is the earliest documentation of meeting sepsis criteria while the patient is in the hospital (SIRS plus a source) and can be from the nursing notes, triage vitals and triage statement, or later in the hospital stay (even on the floor). If the patient has only sepsis criteria first (SIRS plus suspected source) then LATER becomes hypotensive or has an elevated lactate, then the clock presumably only starts at the time those occur.

The second element requires by 6 hours of care

1. 1. apply pressors for persistent hypotension not responding to 30 ml/kg  to maintain MAP >65
2. 2. to perform volume status reassessment by 6 hours if there is persistent hypotension not responding to 30 ml/kg fluid bolus OR lactate greater than 4.0
3. 3. to redraw lactate only if elevated above lab upper limit of normal (even if below 4.0)

Notably absent is the old NQF requirements for CVP or ScVo2 measurement for patients who are persistently hypotensive or with elevated lactates, however this has been replaced by the “volume status reassesment” which can be met in the following way:

• Repeat focused exam (after initial fluid resuscitation) by licensed independent practitioner including vital signs, cardiopulmonary, capillary refill, pulse and skin findings

Or •

Two of the following:  

Measure CVP  

Measure ScvO2  

Bedside cardiovascular ultrasound  

Dynamic assessment of fluid responsiveness with passive leg raise or fluid challenge

http://www.qualityreportingcenter.com/wp-content/uploads/2015/09/IQR-Sepsis_20150910_vFINAL1.pdf

Specific guidelines about how these data are abstracted were reviewed in a CMS webinar on Oct 26  

http://www.qualityreportingcenter.com/event/october-26-2015-iqr-sep-1-early-management-bundle-severe-sepsis-septic-shock-part-iii-measure-updates-and-abstraction-guidance/

and an October 6, 2015 Webinar with Dr Townsend, Dr Tefera, and Dr Rivers was broadcast and a recording can be accessed here:

http://www.qualityreportingcenter.com/inpatient/iqr/events/

Importantly, patients are not excluded from these measure collections if they are DNR, they are only excluded if there is a specific order for comfort care in the first 3 hours for severe sepsis and the first 6 hours for septic shock.

Boris, the Robotic Car, Here to "Pickup and Dropov"

I asked my 2 year old son what t-shirt do you want to wear today and he said, "the Robot shirt".  Like most 2 year olds he has a fascination with robots, cars trucks and all sorts of other machines. His fascination is a mixture of fear and excitement;  Drones, he says, "no, no like it" but very excited by things like garbage trucks which to me are far more dangerous and smelly. 

Shortly after my son was born and I tried to take him hiking with a carrier pack I traded my Mini Cooper in for a Subaru. My Subaru is nothing like Bill Gottlieb's green station wagon which once haunted the streets of the meatpacking district in New York,  nor like the Volvo owned by Ikea magnate Ingvar Kamprad, nor like the Subaru Brat driven by Reagan before he became president.  

" I don't even like old cars.
I'd rather have a goddamm horse.
A horse is at least human,
for God's sake." -J.D Salinger

Mine is thoroughly modern, with Eyesight, obstacle avoidance, and adaptive cruise control, lane change warnings, such that I can just set the cruise control a little above the speed of traffic and it will keep up with the car in front of it. It almost drives itself, so every time I drive, I long for the time cars become driverless robot machines. For, once cars become driverless, instead of horseless carriages, they become removed of any nostalgic connections, animism or personification. For centuries, humans rode horses, then about three generations ago they stopped doing so, and the love of horseman for his steed needed to be channeled into something, it is my own personal theory that America's love affair with the car is less about their curves and the freedom to explore than some misplaced anachronistic devotion to their horse. Some authors cast the "love affair with the car" to a PR campaign by the auto industry  , and Daniel Lazare has described the dominance of auto industry in crafting the structure of the built environment epitomized in the freeway systems of the 50's and the idea of the automotive city advanced as an adaptation of English common law in which not all users of a right of way have equal rights, primacy being given to automobiles. This leftist  and to a degree anarchist viewpoint spews and fumes anger towards cars and their negative externalities, but seems to ignore the negative externalities which must be born by anyone who has to navigate horse poo, or deal with the negative externality of a mud stripe on one's back side when riding to work on a bicycle in a rain. No transport is perfect. No, I prefer to take the attitude that Americans love their cars because they were taught to love their horses, much like the Hindu love their sacred cows. I must admit, in fairness, that my surname literally means in Gaelic, a man who rides a horse, so this is coming from a biased source. 

Polishing the bumper of a monster
truck in a handicapped spot.

This theory that Americans love their cars much as appendages of themselves, in the way one loves one's pet, or horse is the only way that I can explain why in American culture, particularly in the suburban American cities west of the Mississippi and mostly in California, we have devoted a massive swath of the physical real estate footprint to cars. I think that it is because we think of the car as an extension of our self, it goes everywhere with us, we think of it as an expression of our personality, we live out of our cars. As cars were once extensions of ourselves, so too have phones, and selfies, become extensions of our selves in our narcissistic culture. The idea of robotic cars is closed connected to another utopian ideal, that of car sharing. In a former life, I did live in New York and did make use of Zip Car occasionally. Yet the car sharing mentality, like the bike sharing mentality, while certainly having it's merits, namely almost completely eliminating the need for parking in the public doman,  simply will not catch on in a self absorbed, individualistic culture that exists in America today. People will not be dropped off in driverless cars and then wait for the next one to come in an endless cycle of musical chairs shuffling from one driverless taxi to the next. As this man polishing his bumper demonstrates, Americans love their horses far too much. 

 I went to the doctor the other day, and as I was in the elevator going back to my car, I glanced at the emergency exit map for the property and snapped a photo of the map of the medical offices that sums it up fairly well, the majority of space on the property is taken up by cars.
Just imagine what the world would be like if, instead of using that space for cars, it could be dedicated to solutions for homelessness, or a market for healthy food co located with the doctor's offices, or gym space, or a park, or a community garden, just any number of wonderful uses instead of cars. As I walked to my car to go home, I wished I had not driven to the doctor's office, and as I listened to the radio program about the controversy around SANDAG's transportation plan , the controversy about carbon emissions and public transit in San Diego rumbled through the back burner of my mind like an N or Q train rolling over the Manhattan bridge at midnight. I thought back to all the ways my life has changed since I stopped using public transit. It is impossible basically to get around and make appointments on time without a private vehicle in California, yet it occurred to me that the only way to get me out of my car now is if the line in the Starbuck's drive through is too long, or there is literally no place to park. Driverless cars will change all that. 

If our streets and roads and highways are hot hostile expanses of noisy concrete and asphalt which drag all aesthetic appeal from any urban environment, think how this might change with driverless cars. Recently I had the opportunity recently to visit Rome a fitting example for the development of this idea, as all roads, to borrow a phrase, do lead to Caput Mundi. To see how things can change over centuries, consider the Piazza Navona. On the left, the Piazza Navona can be seen at dawn as the remnant of the inner ring of a large athletic competition arena, in which the dawn solitude makes it easy to imagine back to a time of cheering gladiators and chariots racing around that ring, much as cars today dominate urban streets.
To the right is a video of the Piazza Navona in late afternoon, from essentially the same vantage point, when it is swamped by pedestrians and tourists. Now imagine, the consequences if what used to be city streets clogged with cars and parking for the last fifty years became pedestrian avenues. Every main street and downtown district in the US would cease to have a requirement for parking on the main street with driverless cars, as cars could simply valet their occupants to the desired destination, and then be off to park in a single centralized urban parking garage, and summoned to wherever the owner desired once the pedestrian had finished their urban walkabout. Several years ago, I had a conversation with a friend who became the mayor of a small California city. One of the challenges facing the city was a debate as to whether the main street and downtown parking should be free, or should incur parking charges and meters, and at what cost.

The nature of this debate would be fundamentally different were driverless cars an option, as driverless cars could simply valet their occupants, and urban retail streets could be given over to outdoor cafes, beautiful fountains, gardens, and play areas for children. The regional planning budgets and frameworks for civic and regional planning are about to be thrown completely out the window when driverless cars become standard in the next decade,as referred to here, think of the disruptions the technological revolution will have on airport rental car parking garages, the city codes one must revise to turn a mega mall parking lot into a city park or a community farm, and the effect on housing in what are forecast to be the megacities of the future. One only has to look to Piazza Navona to see that the same space can look dramatically different when taken over by pedestrians, and that over the years, a public space can morph into many different uses.

Our ideas of parking garages might change dramatically if cars became driverless, as options to pack, store, and wedge cars systematically and by algorithm without the need for occupant egress could increase the efficiency of the parking process. Instead of being driven, cars could be hung via cable on the sides of buildings, stacked, and taken into deep underground storage locations with less need for ventilation due to the cars being driverless and, in the near future, with an emission free electric drive mechanism eliminating the need for underground ventilation almost entirely. 

As I walked around Roma and later, Firenze, I began to wonder how it was that people with

wheelchairs managed to navigate the city, with it's steps and difficult streets. It became clear to me that by having to navigate such a difficult urban terrain on foot, people became used to it and this kept them fit to a degree not found in the daily navigation tasks of American daily life. One of the possibilities that driverless cars open up is the idea that the village can be reclaimed by pedestrians, that package deliveries within villages and to stores can be achieved by small electric robotic trucks or drones operating from smaller distribution nodes, and that multiple small trips can be achieved on foot or bicycle and that one could walk around and send the robotic car to pick up preselected physical items from distribution points. In this way, rather than spending all of the time getting in and out of a car going from store to store, one could take a pleasant walk and spend time exercising while the robotic car met you at some location different from where you started. For example, one morning in Firenze I walked from my bed and breakfast to Piazzale Michelangelo. As I had no car, I was able to do so, and later take a taxi back in the evening. My daily routine and ability to walk wherever I liked could change quite a bit if, with the option of a driverless robotic car, I could at the end of the walk summon the car to pick me up with a fresh change of clothes and water, rather than having to spend my walk in a round trip pattern, exercise could head off wherever one wanted to go, being limited in no way by the need for a place to park at a trailhead, For example if I wanted to run along the Hudson river, I could in New York run from Battery Park and then up to Central Park and have my own robotic car meet me at the destination with a change of clothes for a morning meeting. In fact, the ability to configure internal space for multiple purposes, robotic cars in the future might have the ability to include a personal hygiene space, allowing for women to change outfits or even use the space to use a breastpump while taking a lunch break and then transport the breast milk for storage.

If we see further, it is because we are
standing on the shoulders of giants. -Isaac Newton

As I wedge my son into his rear facing car seat, I am confident that in the next two decades, as he becomes a driver himself, some of these changes will come to fruition, and the world we will see unfold before our eyes will be as breathtaking to us as geosynchronous satellite orbit would be to Galileo. I am also wondering what will be the fate of municipal bonds used to finance current construction projects that do not account for driverless cars in regional planning budgets of the future.