The American Academy of Neurology (AAN), the American Neurological Association (ANA), and the Child Neurology Society (CNS) have issued a position statement calling for laws to require a uniform definition of brain death (). They endorse legislation modeled after a Nevada statute, which specifically defers to current adult and pediatric Brain Death Guidelines and any future updates.
This is an issue near and dear to our hearts. Dr. Truax, along with Dr. Rick Munschauer, co-authored New York State’s first braindeath determination criteria in the mid-1990’s. These arose out of very practical considerations. At the University of Buffalo we had a consortium of teaching hospitals. Our neurology residents rotated through 6 hospitals. Unfortunately, they encountered different policies and approaches to braindeath determination at each hospital. That led us to convene local stakeholders to develop a uniform policy and approach for all our consortium hospitals.
Shortly after we had developed our local consortium guidelines, the New York State Department of Health convened a group of representatives from all over New York to address this issue. Dr. Fred Plum chaired the group’s sessions. We ended up adopting statewide the Buffalo criteria with a few modifications. These were the first official guidelines in New York. Dr. Truax subsequently served as the Department of Health’s spokesperson on the criteria for the next 10 years.
While the need for uniformity was the most compelling reason for development of such criteria, there were other important considerations as well. Prior to that work, most neurologists and neurosurgeons informally used the “Harvard criteria”, which had been developed years earlier. The Harvard criteria, in addition to demonstration of cessation of all brainstem and cortical function, required 2 EEG’s done 24 hours apart that demonstrated no evidence of electrocortical activity. They also required 2 neurological exams (24 hours apart) and that 2 neurologists or neurosurgeons be involved in confirmation of braindeath.
That led to several problems. One was that it had implications for organ donation and organ procurement (the long delay sometimes led to lack of viability of organs that might have been donated). The other major issue was that not all hospitals had ready availability of EEG’s and many, particularly small rural hospitals, did not have access to 2 neurologists or even any neurologists or neurosurgeons.
So, the criteria we developed included the usual bedside clinical determination of absence of both cortical and brainstem function and demonstration of lack of respiration when there was an adequate physiologic stimulus that should have caused respiration (we developed recommendations as to how to appropriately perform and interpret the apnea test). And we allowed use of a test demonstrating lack of intracerebral blood flow as a confirmatory test that might be particularly useful in those cases where adequate assessment of brainstem function was not possible (eg. in a patient with severe facial trauma). Of course, the criteria also required that factors such as hypothermia or presence of CNS depressant drugs be excluded. In practice, the criteria reduced the minimum period required for determination of braindeath from 24 hours down to 6 hours.
There was also another confounding factor. Though New York State already had a statute that stated braindeath equated to death (i.e. that once someone was declared braindead, they were officially dead), there were certain religious or cultural groups that did not accept the concept of braindeath. Hence, we required that all hospitals have in place a special accommodations for families of such religions. Usually this meant allowing families some time to spend with the patient after declaration of braindeath before the patient was actually removed from ventilatory support. Hospitals were required to specify what other treatments (IV fluids, feedings, antibiotics, vasopresors, etc.) would be suspended during that period.
New York State modified the braindeath determination criteria somewhat in the mid-2000’s and the AAN (American Academy of Neurology) published its updated braindeath determination criteria in 2010.
The new position paper states “The brain death standards for adults and children that are now widely accepted and used are the AANs 2010 Evidence-Based Guideline Update: Determining Brain Death in Adults () and the 2011 Guidelines for the Determination of Brain Death in Infants and Children ( ), issued by the Pediatric Section of the Society of Critical Care Medicine, the Sections of Neurology and Critical Care, the American Academy of Pediatrics and the Child Neurology Society.”
The current call for legislation is for all states to develop statutes that adopt the above criteria. To date, apparently only Nevada has formally adopted those criteria and gudelines.
AAN acknowledges that braindeath determination is a basically a clinical determination and that the primary role of any ancillary testing is to serve as a surrogate when portions of the clinical exam cannot otherwise be performed (for example, as above, due to severe facial trauma). AAN also reaffirms that, while accommodating for religious or cultural beliefs, there is no ethical obligation to provide medical treatment to a deceased person. The AAN position paper has a good discussion about how to handle such accommodations. It also makes recommendations for transfer of care when a physician has objections to the braindeath determination concept based on religious or moral conscience.
AAN also encourages the development of programs that train and credential physicians who determine brain death and that public and professional education be provided regarding brain death and its determination. We mentioned before that some small, rural hospitals may not have a neurologist or neurosurgeon on staff to make braindeath determnations. But each hospital can have other physicians trained to do braindeath determinations. We do recommend that each hospital not only adopt the criteria but specify which physicians will be credentialled and privileged to do those determinations and what criteria will be required for that credentialing.
We concur with the AAN position paper that it is desirable that all states adopt legislation that would make the determination and process for braindeath determination uniform throughout the US.
Russell JA, Epstein LG, Greer DM, et al. on behalf of the Brain Death Working Group. Brain death, the determination of brain death, and member guidance for brain death accommodation requests. AAN position statement. Neurology 2019; Published ahead of print January 02, 2019
Wijdicks EF, Varelas PN, Gronseth GS, Greer DM. Evidence-based guideline update: determining brain death in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2010 ; 74(23): 1911-1918 First published June 7, 2010
Nakagawa TA, Ashwal S, Mathur M, Mysore M, the Society of Critical Care Medicine, Section on Critical Care and Section on Neurology of the American Academy of Pediatrics, and the Child Neurology Society. Guidelines for the Determination of Brain Death in Infants and Children: An Update of the 1987 Task Force Recommendations. Pediatrics 2011; 128(3):
(reaffirmed April 2015) Pediatrics 2015; 135(4): 31105
A California hospital was fined $30,000 for overlooking a serious case of constipation that led to significant patient morbidity ( ). The patient did not have a bowel movement for 10 days. The patient had been prescribed numerous opioids known for causing constipation, yet, the facility waited 8 days after her last bowel movement to respond to her constipation symptoms. Ultimately, the patient had a toxic megacolon and required additional surgery.
CDPH noted the facility failed to develop a post-operative plan of care that included bowel care and failed to implement a care plan requiring assessment of pain medication side effects. It also failed to recognize a nursing diagnosis of severe constipation and intervene by promptly notifying the physician.
The patient was a 71 year old who was admitted to the hospital on 11/20/17 for lung surgery. A pre-operative note stated her last bowel movement was on 11/18/17. Post-operatively she was administered numerous opioid pain medications. She had no bowel movements postoperatively but a physician was first notified of the problem on 11/26/17. Then the physician’s orders for a stool softener and a twice daily laxative (milk of magnesia) were delayed 12 hours because the facility’s protocols for orders written after 9:00 AM defaulted to begin at 9:00 PM. Obstipation persisted and, on 11 /28/17, a nurse noted that the patient's abdomen was tender throughout, with no bowel sounds and was not passing gas. Multiple Fleet’s enemas were administered and the patient was given magnesium citrate and lactulose. After a soap suds enema on 11/29 there was “medium sized” bowel movement but a soap suds enema was repeated again with no results.
Multiple enemas followed by a Gastrografin enema and an attempt to try to decompress the bowel by use of suction through a tube were unsuccessful. White count progressively rose and follow up CT scan revealed persistent cecal dilatation. The patient returned to surgery on 11 /29/17 at 11 :30 PM to evacuate the colon, where it was discovered she had toxic megacolon (acute colonic distension characterized by a very dilated colon) with areas of ischemia.
Very timely was a recent article in ACP Hospitalist (Latorre, MD had given at American College of Gastroenterology 2018).) suggesting we approach constipation aggressively and offering tips on inpatient constipation (based on a talk Melissa
Dr. Latorre’s first tip is to be proactive. Rather than leaving orders for “prn” bowel care, she recommends standing orders for laxatives, with an opt-out policy to hold if the patient has had more than two bowel movements or is having diarrhea (keeping in mind that occasionally you might be fooled by “overflow” diarrhea).
She recommends both “induction” and “maintenance” therapies and “above” and “below” approaches. The induction phase may consist of an osmotic laxative such as polyethylene glycol, 17 g in 8 ounces of water, either two or three times a day, or colonoscopy prep if the patient can tolerate it. She avoids use of fiber or lactulose or oral stimulants upfront, because they may exacerbate symptoms like bloating, abdominal pain, and abdominal distension. From below, induction can include manual maneuvers and suppositories. “Glycerin may help to soften the stool and bisacodyl may help with rectal motility.” Once there has been a bowel movement, some enemas (mineral oil or tap water) may help.
Once the patient is eating again, a maintenance phase would include providing fiber, water or IV fluids, and oral laxatives. For those patients on opioids, an opiate-receptor antagonist may be indicated. Optimizing the patient's underlying medical condition is also important.
She also cautions that not all constipation is functional or opioid-induced. You always need to consider small-bowel obstruction, large-bowel obstruction, acute pseudo-obstruction, volvulus, toxic megacolon, and perforation. We especially refer you to our May 14, 2013 Patient Safety Tip of the Week “”.
She notes that postoperative ileus is also a common condition. But constipation beyond 4 days is of concern, particularly if two or more of the following are present: nausea, vomiting, inability to tolerate diet over the prior 24 hours, absence of flatus in the preceding 24 hours, abdominal distension, radiologic evidence. Management includes IV fluids, electrolyte repletion (especially potassium and magnesium), mobilization as tolerated, and nutritional support. Anti-emetics or laxatives may be needed for symptomatic relief. You should try to identify any drugs that may be exacerbating the problem. GI decompression might be appropriate for some patients (as we discussed in our column on Ogilvie’s Syndrome). Pharmaceutical interventions require some caution. Neostigmine is approved for acute pseudo-obstruction and large-bowel ileus but you must closely monitor patients for severe bradycardia and bronchospasm. Alvimopan is FDA-approved to accelerate upper and lower GI recovery following a partial small-bowel resection with primary anastomosis but carries a black box warning about the risk of myocardial infarction.
Butterfield also ends the ACP Hospitalist article with Latorre’s comment that chewing gum has also been reported to be of some benefit!
While we generally recommend that standardized order sets avoid “prn” orders for certain things that may not be necessary during a hospital stay (such as sleep medications), there are clearly patients at risk for constipation in whom proactive standing orders make sense. It is particularly important that such do address constipation in patients who are prescribed opioids, particularly following surgery. We like the approach Latorre has outlined.
CDPH (California Department of Public Health). Complaint Intake Number: CA00563555. CDPH 2018; December 6, 2018
Butterfield S. Approach constipation aggressively. An expert speaking at American College of Gastroenterology 2018 gave tips on inpatient constipation. ACP Hospitalist 2018; December 2018
We’ve reminded our anesthesiology colleagues in a couple columns that they have a role in preventing surgical site infections (see our December 28, 2010 Patient Safety Tip of the Week “August 2012 What's New in the Patient Safety World column “ ” and our ”).
Now SHEA (Society for Healthcare Epidemiology of America) has just published an expert guidance on “Infection prevention in the operating room anesthesia work area” ()
The recommendations for hand hygiene are that it should be performed, at a minimum:
· before aseptic tasks (eg, inserting central venous catheters, inserting arterial catheters, drawing medications, spiking IV bags)
· after removing gloves
· when hands are soiled or contaminated (eg, oropharyngeal secretions)
· before touching the contents of the anesthesia cart
· when entering and exiting the OR (even after removing gloves)
They also recommend anesthesia providers should consider wearing double gloves during airway management, remove the outer gloves immediately after airway manipulation, and remove the inner gloves and perform hand hygiene as soon as possible.
They recommend facilities locate alcohol-based hand rub (ABHR) dispensers at the entrances to ORs and near anesthesia providers inside the OR in order to promote frequent hand hygiene. Wearable ABHR dispensers with audible reminders increased the frequency of hand hygiene in several studies, as well as having the potential to decrease the incidence of HAI’s. They also stress the importance of delegating responsibility for filling of the ABHR dispensers to designated personnel and regularly ensure compliance with this practice.
They did not take a position on the question of whether applying ABHR’s over gloves that have been worn in a case is an acceptable alternative to removing the gloves, performing hand hygiene, and regloving with new sterile gloves (citing lack of evidence for or against).
They then had a series of recommendations regarding disinfection and/or sterilization of instruments and work areas:
Standard direct laryngoscope or video-laryngoscope reusable handles and blades should undergo high-level disinfection (at the minimum) or sterilization prior to use, or that reusable laryngoscopes are replaced with single-use standard direct laryngoscopes or video-laryngoscopes. Clean blades and handles should be stored in packaging appropriate for semicritical items designated for “high-level” disinfection.
High-touch surfaces on the anesthesia machine and anesthesia work area should
be cleaned and disinfected between OR uses with an EPA-approved hospital disinfectant that is compatible with the equipment and surfaces based on the manufacturers’ instruction for use. There should be prioritization of cleaning of the specific components
that are most likely to be contaminated. Monitoring equipment such as reusable blood pressure cuffs, pulse oximeter probes, electrocardiogram (ECG) leads, twitch monitor leads and sensors, and cables that are in physical contact with patients should receive high priority for thorough cleaning They note that single-use monitoring sensors may be useful for reducing the cleaning burden. The anesthesia machine work surface, gas flow controls, vaporizer dials, adjustable pressure limiting valve (APL), IV stands and fluid warmers, supply cart, and computer keyboard and mouse, are also examples of components that are particularly likely to be contaminated.
Then they make recommendation regarding IV’s, access ports, and other items related to vascular access and injection practices. Only disinfected ports should be used for intravenous access. Medication vials’ rubber stoppers and necks of ampules should be wiped with 70% alcohol prior to vial access and medication withdrawal. All central venous catheters (CVCs) and axillary and femoral arterial lines should be placed with full maximal sterile barrier precautions. Full maximal sterile barrier precautions include wearing mask, cap, sterile gown, and sterile gloves and using a large sterile drape during insertion. Peripheral arterial lines (eg, radial, brachial, or dorsalis pedis arterial lines) should be placed with a minimum of a cap, mask, sterile gloves, and a small sterile fenestrated drape.
IV drug injection recommendations include using syringes and vials for only one patient; and that injection ports and vial stoppers should only be accessed after disinfection. Any provider-prepared sterile injectable drugs should be used as soon as practicable following preparation. And the time between spiking IV bags and patient administration should be minimized.
After each case there should be cleaning and disinfection of computer keyboards and touchscreen computer monitors, using a hospital-approved disinfectant consistent with manufacturers’ recommendations. Cleaning and disinfection should also occur every
time there is obvious soiling or contamination of anesthesia work surfaces.
They also have recommendations for dealing with patients on contact isolation, including performing hand hygiene and using appropriate personal protective equipment (PPE), and performing environmental disinfection that follows recommendations regarding cleaning between cases, irrespective of an individual patient’s multidrugresistant organism status.
The recommendations also note the importance of leadership and champions and having goals to have an effective infection control program. They stress audit and feedback, particularly for hand hygiene practices.
The guidance was endorsed by the SHEA Board of Trustees, the American Academy of Anesthesiologist Assistants (AAAA), AANA, the Association for periOperative Registered Nurses (AORN), and APSF, with a letter of support from ASA.
There are a few things we would have liked to see in these guidelines as well. We still often see anesthesiologists (and other OR personnel) having lunch in the cafeteria wearing surgical “scrubs”. The guidance makes no mention about OR garb. Nor does it mention that OR garb should be laundered in the facility laundry, not taken home to be laundered. And it does not mention the role the anesthesia providers can play in limiting OR foot traffic and door opening, which are factors that can increase the risk of surgical infections. And perhaps some more comments about stethoscopes, given a recent article about widespread contamination of stethoscopes in ICU’s (Knecht 2018). And what about those everpresent cellphones?
Some of our other columns on handwashing and hand hygiene:
January 5, 2010 “ ”
December 28, 2010 “ ”
May 24, 2011 “ ”
October 2011 “ ”
March 2012 “ ”
August 2012 “ ”
October 2013 “ ”
November 18, 2014 “ ”
January 20, 2015 “ ”
September 2015 “ ”
November 2015 “”
April 2016 “”
August 2016 “”
September 2016 “”
July 18, 2017 “”
Some of our prior columns on HAI’s (hospital-acquired infections):
December 28, 2010 “ ”
October 2013 “ ”
February 2015 “ ”
April 2016 “”
September 2016 “”
November 2018 “”
December 2018 “”
January 2019 “”
Munoz-Price LS, Bowdle A, Johnston L, et al. Infection prevention in the operating room anesthesia work area. Infect Control Hosp Epidemiol 2018; Published online: 11 December 2018
Knecht VR, McGinniss JE, Shankar HM, et al. Molecular analysis of bacterial contamination on stethoscopes in an intensive care unit. Infect Control Hosp Epidemiol 2018; . published online December 12, 2018
As we pretty much anticipated (see our October 2018 What's New in the Patient Safety World column “”), the recent legislative initiative in Massachusetts to mandate nursing staffing levels failed. We were concerned that the uncertain costs of implementing this legislation would lead to it being voted down and that a potentially useful strategy for improving patient care would be lost. We felt it would have been more politically expedient for Massachusetts to have funded a semi-controlled study in which the state would select a representative sample of different types of hospital (academic, community, rural, etc.) and foot the cost of any upgraded staffing there (CMS and other third party payers could also have contributed to such funding) and then compare patient outcomes against all the other hospitals. But that didn’t happen and Massachusetts voted “no” on the proposal.
It’s been almost 2 decades since California passed the first law mandating minimum nurse:patient staffing levels. But we continue to debate this topic even today.
You’ll recall that a seminal study by Aiken and colleagues found that each additional patient per nurse was associated with a 7% increase in the likelihood of dying within 30 days of admission and a 7% increase in the odds of failure-to-rescue ( ).
Last year the results of a study assessing the impact of a Massachusetts law, which required a 1:1 or 2:1 patient-to-nurse staffing ratio in intensive care units were published (). The researchers compared staffing levels and mortality and certain patient complications between Massachusetts ICU’s and out-of-state ICU’s. There actually were only modest increases in ICU nurse staffing ratios in Massachusetts (from 1.38 patients per nurse before implementation to 1.28 patients per nurse after) and those staffing increases were largely mirrored in other states that did not have the mandate. Massachusetts ICU nurse staffing regulations were not associated with changes in hospital mortality within Massachusetts or when compared with changes in hospital mortality in other states. Complications and DNR orders also remained on either staffing levels or patient outcomes. We might have predicted that, because ICU’s are already staffed at high levels, we would not see much change.
But since then, there has been another study linking poor nursing staffing levels to increased patient mortality. A study in the UK (Griffiths 2018) looked at in-hospital mortality in relation to nursing staffing, comparing those with staffing levels above to those below the mean staffing level. They found the hazard of death was increased by 3% for every day a patient experienced RN staffing below the ward mean. Each additional hour of RN care available over the first 5 days of a patient’s stay was associated with 3% reduction in the hazard of death. And, days where admissions per RN exceeded 125% of the ward mean were associated with an increased hazard of death (aHR 1.05). Although low nursing assistant staffing was associated with increases in mortality, high nursing assistant staffing was also associated with increased mortality.
We fully support legislation that raises nurse:patient staffing ratios. But the issue is more complex than simple nurse:patient ratios. Those ratios do not take into account actual nurse workload nor do they take into account the fatigue factor that may accompany long work shifts or forced overtime. One factor that comes into play in those conditions is the concept of “missed nursing care” or “care left undone” (see our Patient Safety Tips of the Week for November 26, 2013 “ ” and May 9, 2017 “”).
We discussed the issue of nursing workload in detail in our Patient Safety Tips of the Week for March 6, 2018 “” and May 29, 2018 “”. In those columns we discussed the issue of how to best measure workload.
A prospective study in a level IV NICU in a Midwestern academic medical center evaluated the association between nurse workload and missed nursing care (eg, each 5-point increase in a nurse’s NASA-TLX rating during a shift was associated with a 34% increase in the likelihood of missing a nursing assessment for his or her assigned infants during the same shift). The authors conclude that subjective workload represents an important aspect of nurse workload that remains largely unmeasured despite high potential for intervention.). Workload was assessed each shift with objective measures (infant-to-nurse staffing ratio and infant acuity scores) and a subjective measure (the National Aeronautics and Space Administration Task Load Index [NASA-TLX]). They found a significant worsening association of increased NASA-TLX subjective workload ratings with odds of missed care (
Another study, conducted in the US (), surveyed nurses in almost 600 hospitals in 4 states and looked at factors that led to nurses giving their hospital poor or failing patient safety grades. A 1-unit increase in “engagement” lowered the odds of an unfavorable safety grade by 29%. Hospitals where nurses reported higher levels of engagement were 19% less likely to report that mistakes were held against them. And, nurses in poorly staffed hospitals were 6% more likely to report that important information about patients “fell through the cracks” when transferring patients across units.
Most of the studies on missed care have come from med/surg units or ICU’s. A recent study administered the MISSCARE questionnaire (see our May 9, 2017 Patient Safety Tip of the Week “”) to nurses in a cancer center (). Frequently perceived elements of missed nursing care were ambulation, turning every 2 hours, and care conference attendance. Surgical units reported 0.24 higher scores than medical units, and hematology units reported 0.26 lower scores than surgical units. The authors note that the findings suggest that perceived missed care in a comprehensive cancer center is similar to that in other hospital settings.
We continue to be strong believers that nursing staffing levels do influence patient outcomes. But as we’ve discussed in so many prior columns, there needs to be a match between staffing levels and nursing workload. Patient acuity is only one potential component of workload. In our prior columns we noted several tools that have been used as better measures of nursing workload. The time has come for a randomized study that compares current staffing practices with practices that take into account nursing workload. Such a study will not be easy to do. First, you need to decide the unit of randomization (will it be at the hospital level, or do you compare ICU vs. ICU, or med/surg unit vs. med/surg unit). Then you need to apply an appropriate measure of workload. And, the most difficult task will be determining how the intervention (that is, adjusting the nurse staffing each day or each shift based upon the workload measure) will be implemented. Lastly, it will be difficult to exclude some element of bias. We would anticipate that more nurses may try to be scheduled to work on the “intervention” units because they may anticipate a better work environment. The latter may be a reason to randomize at the hospital, rather than unit, level but it would likely be more difficult to account for confounding factors (patient severity, socioeconomic factors, etc.) at the hospital level.
Some of our other columns on nursing workload and missed nursing care/care left undone:
November 26, 2013 “ ”
May 9, 2017 “”
March 6, 2018 “”
May 29, 2018 “”
October 2018 “”
Aiken LH, Clarke SP, Sloane DM, et al. Hospital Nurse Staffing and Patient Mortality, Nurse Burnout, and Job Dissatisfaction. JAMA 2002; 288(16): 1987-1993
Law AC, Stevens JP, Hohmann S, et al. Patient Outcomes After the Introduction of Statewide ICU Nurse Staffing Regulations. Critical Care Medicine 2018; 46(10): 1563-1569
Griffiths P, Maruotti A, Recio Saucedo A, et al. on behalf of the Missed Care Study Group. Nurse staffing, nursing assistants and hospital mortality: retrospective longitudinal cohort study. BMJ Qual Saf 2018; Published Online First: 04 December 2018
Tubbs-Cooley HL, Mara CA, Carle AC, et al. Association of Nurse Workload With Missed Nursing Care in the Neonatal Intensive Care Unit. JAMA Pediatr 2018; Published online November 12, 2018
Brooks Carthon JM, Hatfield L, Plover C, et al. Association of Nurse Engagement and Nurse Staffing on Patient Safety. Journal of Nursing Care Quality 2019; 34(1): 40-46
Villamin C, Anderson J, Fellman B, et al. Perceptions of Missed Care Across Oncology Nursing Specialty Units. Journal of Nursing Care Quality 2019; 34(1): 47-53
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