Our March 15, 2016
Patient Safety Tip of the Week “Dental
Patient Safety” noted
numerous cases of death related to sedation in dental practices. The majority
of those cases occurred in pediatric patients. A recent article in Anesthesiology
News (Kronemyer
2016) noted that a KVUE TV “Defenders”
investigation (Pierrotti
2016) identified at least 85
patients in Texas who died shortly following dental procedures from 2010 to
2015. The Kronemyer article also notes that
the American Dental Association (ADA) guidelines on sedation do not
specifically address pediatric dental issues and that statewide regulations
regarding dental sedation and
anesthesia vary widely. That article notes that the ADA defers to the American
Academy of Pediatrics (AAP)/American Academy of Pediatric Dentistry (AAPD)
“Guideline for Monitoring and Management of Pediatric Patients During and After
Sedation for Diagnostic and Therapeutic Procedures.” Fortunately, the latter
guideline has just been updated (Coté 2016).
The updated guideline, which applies to not just dental
procedures but to sedation for all procedures, notes that children under the
age of 6 years (and especially those under the age of 6 months) are
particularly likely to suffer adverse events during sedation. It emphasizes
that there is a very narrow margin in children between the intended level of
sedation and much deeper sedation or anesthesia. Therefore, the practitioner
must be trained not only in moderate sedation but must have the skills to
rescue patients from such deeper levels. That would include the need for maintenance
of the skills needed to rescue a child with apnea, laryngospasm, and/or airway
obstruction, include the ability to open the airway, suction secretions,
provide continuous positive airway pressure (CPAP), perform successful
bag-valve-mask ventilation, insert an oral airway, a nasopharyngeal airway, or a
laryngeal mask airway (LMA), and, rarely, perform tracheal intubation. The
guidelines note these skills are likely best maintained with frequent
simulation and team training for the management of rare events. The guideline
has specific recommendations for when the intended level of sedation is
minimal, moderate, deep or general sedation.
The updated guideline emphasizes the role of capnography in appropriate physiologic monitoring and continuous observation by personnel not
directly involved with the procedure to facilitate accurate and rapid
diagnosis of complications and initiation of appropriate rescue interventions.
You’ll recall from our March 15, 2016
Patient Safety Tip of the Week “Dental
Patient Safety” that many of
the fatalities following sedation for dental procedures had the dentist or oral
surgeon both doing the procedure and monitoring the patient.
Patient safety considerations for procedural sedation begin
in advance of the procedure. There should be a careful preprocedure review of the patient’s underlying medical conditions and consideration
of how the sedation process might affect or be affected by such conditions. The
guideline specifically mentions that children with developmental
disabilities have been shown to
have a threefold increased incidence of desaturation compared with children
without developmental disabilities.
The SOAPME
mnemonic is used to help teams remember all the equipment and supplies needed
for conduct of safe sedation:
S Suction
O Oxygen;
an adequate reserve supply
A Airway; size-appropriate equipment to
manage a nonbreathing child
P Pharmacy;
drugs needed to support life and appropriate reversal agents
M Monitors;
size-appropriate oximeter probes/monitors appropriate for procedure
E Equipment;
a defibrillator with appropriately sized pads
Without going into details about specific drugs, the
guideline notes the importance of selecting
the lowest dose of drug with the highest therapeutic index for the
procedure. That choice should also depend on whether the procedure is expected
to be a painful or non-painful procedure. Knowledge
about the duration of action of the drugs is important in informing how
long a patient needs to be monitored after the procedure. That is especially
important when combinations of drugs are being used (eg.
a sedating agent and an analgesic or anxiolytic agent).
The guideline has specific recommendations for when the
intended level of sedation is minimal, moderate, deep or general sedation. One
critical point that should be of particular concern for dental practices, is
that use of moderate or deeper sedation shall include the provision of a person, in addition to the practitioner,
whose responsibility is to monitor appropriate physiologic parameters and
to assist in any supportive or resuscitation measures. While that individual
might also be responsible for assisting with interruptible patient-related
tasks of short duration, such as holding an instrument or troubleshooting equipment,
the primary role of that individual is
monitoring the patient. For deep sedation the sole role of the support
individual is to monitor the patient. In either case that individual should be
trained in and capable of providing advanced airway skills (eg,
PALS) and shall have specific assignments in the event of an emergency and
current knowledge of the emergency cart/kit inventory.
Monitoring is critical and should include the level of
patient’s ability to communicate (where assessable), heart rate, respiratory
rate, blood pressure, oxygen saturation, and expired carbon dioxide values (via
capnography) should be recorded, at
minimum, every 10 minutes in a time-based record. The guideline stresses use of
capnography but acknowledges that it may not be able to be used in some
procedures around the face, including many dental procedures.
The guideline discusses the needs for the emergency cart/kit
and backup emergency services access and availability.
The guideline has a
good discussion about the use of immobilization devices, such as the “papoose”
boards we mentioned in our March 15,
2016 Patient Safety Tip of the Week “Dental
Patient Safety”. Such must
be applied in such a way as to avoid airway obstruction or chest
restriction and the child’s head position and respiratory excursions should be
checked frequently to ensure airway patency. If an immobilization device is used,
a hand or foot should be kept exposed, and the child should never be left unattended.
The guideline discusses what should be documented before,
during, and after a procedure in which sedation is used and notes the
importance of careful attention to calculating doses of drugs or infusions
based on patient weight.
The guideline has a good discussion about discharge of the
pediatric patient following a procedure in which sedation is used. It
specifically highlights the dangers when a child is transported in a car seat
where there is a need to carefully observe the child’s head position to avoid
airway obstruction. Transportation in a car safety seat poses a particular risk
for infants who have received medications known to have a long half-life. When
there is only one adult to both drive and observe the child, there should be a
longer period of observation in the facility where the procedure occurred.
Discharge instructions should include details about what to look for, activity
levels, dietary restrictions, and include a 24-hour phone number to call if
necessary.
And while we have been emphasizing the application of the
guideline to dental procedures, remember it applies to all diagnostic and
therapeutic procedures. It has an excellent section on sedation in the MRI
suite, which is a very restricted environment and has needs for special
equipment and monitoring techniques as we have discussed in our numerous
columns on patient safety issues in the radiology and MRI suites.
This guideline was extremely well researched, with almost
500 references including the most up-to-date studies and reports. The authors
have produced very valuable recommendations that should improve the safety of
children undergoing sedation for procedures in a variety of settings. You’ll
find this very useful.
References:
Kronemyer B. Deaths of Children During Dental Procedures Raise Safety Concerns.
Anesthesiology News 2016; June 30, 2016
Pierrotti A. Defenders:
Investigating Dental Deaths. KVUE 2016; April 28, 2016
http://www.kvue.com/news/investigations/defenders/defenders-investigating-dental-deaths/158354392
Coté CJ, Wilson S, American
Academy of Pediatrics, American Academy of Pediatric Dentistry. Guidelines for
Monitoring and Management of Pediatric Patients Before, During, and After
Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics 2016;
138(1): e2016121
http://pediatrics.aappublications.org/content/138/1/e20161212
Print “August
2016 Guideline Update for Pediatric Sedation”
Last month we
discussed new guidelines on antibiotic stewardship (see our July 2016 What's New in the Patient Safety World column “NQF/CDC
Guideline on Antibiotic Stewardship”) and in our several other prior columns on antibiotic stewardship
listed below we’ve noted the overprescription of
antibiotics for inappropriate indications, both in hospitals and ambulatory
settings.
One such category
where inappropriate antibiotic prescribing is rampant is the upper respiratory
tract infection (RTI) that is usually self-limited and many of which are caused
by viruses so are not amenable to antibiotic treatment. Many primary care
practitioners remain concerned that failure to use antibiotics in such cases
may lead to adverse consequences in their patients. They often have the
impression that the primary reason for avoiding antibiotic prescribing is to
prevent development of antibiotic-resistant organisms and that such concern
applies to populations rather than to their individual patients. In fact,
that’s not true as we discussed in our November 2015 What's
New in the Patient Safety World column “Medications
Most Likely to Harm the Elderly Are…” that the medications most likely to
harm the elderly are antibiotics.
But it would be
reassuring to see a study showing that avoidance of antibiotics in such cases
is, in fact, safe. So a recent study done in 601 general practices in the UK
provides such welcome reassurance. Researchers used data from the UK Clinical
Practice Research Datalink (Gulliford 2016).
They found that general practices that
adopt a policy to reduce antibiotic prescribing for RTIs might expect a slight
increase in the incidence of treatable pneumonia and peritonsillar
abscess. However, there was no increase likely in mastoiditis, empyema,
bacterial meningitis, intracranial abscess, or Lemierre’s
syndrome.
They estimate that if
a general practice with an average list size of 7000 patients reduces the
proportion of RTI consultations with antibiotics prescribed by 10%, then it
might observe 1.1 more cases of pneumonia each year and 0.9 more cases of peritonsillar abscess each decade. They conclude that even
a substantial reduction in antibiotic prescribing was predicted to be
associated with only a small increase in numbers of cases observed overall, but
caution might be required in subgroups at higher risk of pneumonia.
An accompanying editorial (Del Mar 2016) also finds
some reassurance in these findings. Some rapid response letters (Rapid Response
2016) note the importance of adequate early followup
and cooperation of parents when treating pediatric patients. But another of the
rapid response letters reveals a critical root cause of overprescribing
antibiotics – the already harried general practitioner fears his workday will
become overburdened by patients returning for an additional evaluation.
In our July 2016
What's New in the Patient Safety World column “NQF/CDC
Guideline on Antibiotic Stewardship”) we noted that CMS has announced that hospitals will be required
to have antibiotic stewardship programs and demonstrate that they have reduced
inappropriate antibiotic usage (CMS
2016). Now The Joint Commission has also revised its standard regarding
antibiotic stewardship, effective January 1, 2017 (TJC,
2016).
Elements of the new
TJC standard for include:
As a reminder, the seven
CDC-defined core elements (CDC
2016) of a comprehensive antibiotic
stewardship program are:
The TJC prebulication document also provides links to some useful
tools, such as materials for educating patients and their families
See our columns listed below for ways to deal with the
problem of inappropriate antibiotic prescribing and antibiotic stewardship
programs both in the hospital and the ambulatory setting.
Some of our prior
columns on antibiotic stewardship:
References:
Gulliford MC, Moore MV, Little P,
et al. Safety of reduced antibiotic prescribing for self
limiting respiratory tract infections in primary care: cohort study
using electronic health records. BMJ 2016; 354: i3410 (Published 04 July 2016)
http://www.bmj.com/content/354/bmj.i3410
Del Mar C. Antibiotics for acute respiratory tract
infections in primary care. BMJ 2016; 354: i3482
(Published 05 July 2016)
http://www.bmj.com/content/354/bmj.i3482
Rapid Responses. Antibiotics for acute respiratory tract
infections in primary care. BMJ 2016; 354: i3482
(Published 05 July 2016)
http://www.bmj.com/content/354/bmj.i3482/rapid-responses
CMS (Centers for Medicare & Medicaid Services). CMS
Issues Proposed Rule that Prohibits Discrimination, Reduces Hospital-Acquired
Conditions, and Promotes Antibiotic Stewardship in Hospitals. June 13, 2016
https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2016-Fact-sheets-items/2016-06-13.html
TJC (The Joint Commission). New Antimicrobial Stewardship
Standard (Prepublication Requirements). June 24, 2016
https://www.jointcommission.org/assets/1/6/HAP-CAH_Antimicrobial_Prepub.pdf
CDC (Centers for Disease Control and Prevention). Core
Elements of Hospital Antibiotic Stewardship Programs. Page last updated: May
25, 2016
http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html
Print “August
2016 Some Reassurance on Antibiotic Stewardship”
Two recent studies
suggest that hand hygiene compliance rates are overestimated when healthcare
workers know they are being observed. The first, a California medical center
study presented at the 43rd Annual Conference of the Association for
Professionals in Infection Control and Epidemiology (APIC), found a difference
of more than 30 percent in hand hygiene compliance depending on whether or not
they recognized the auditors (APIC
2016a). The Hawthorne
effect, very loosely applied to imply that behavior changes when subjects know
they are being observed (our apologies to purists who will state that is not
the actual phenomenon observed at Western Electric), appears to result in an
overestimate of compliance with hand hygiene.
The second study, done in Canada, also showed a disparity
between healthcare worker compliance with hand hygiene observed covertly compared
to reporting by staff observers (Kovacs-Litman 2016). Moreover, there may be a disparity in the
phenomenon between physicians and nurses. Canadian researchers trained students
to covertly observe hand hygiene compliance and compared their assessments with
the formal compliance assessments done by hospital staff. The covert observers
noted hand hygiene compliance to be 50% compared to 83.7% reported by the
hospital staff. For physicians compliance reported by hospital auditors and
covert observers, respectively, was 73.2% vs 54.2%, whereas for nurses
compliance reported by hospital auditors and covert observers, respectively,
was 85.8% vs 45.1%.
Importantly, as we’ve often pointed out, the behavior of the
head of the team significantly influences the behavior of all the others. The
researchers noted that physician trainees had much better hand hygiene
compliance when their attendings cleaned their hands
than when they did not (79.5% vs. 18.9%).
Meanwhile, many hospitals have begun to use electronic
monitoring of hand hygiene compliance even though this technology has not yet been
shown to substantially reduce hospital infections. But a new study (Kelly 2016),
analyzing data from 23 inpatient units over a 33-month period found a
significant correlation between unit-specific improvements in electronic
monitoring compliance and reductions in methicillin-resistant Staphylococcus
aureus infection rates.
Another study presented at the recent APIC Annual Conference
found that showing hospital staff enlarged images of bacterial cultures similar
to those they might have on their hands increased compliance with hand hygiene
by 11-46% (APIC
2016b).
Of course, the attending physician serving as a role model
for hand hygiene and the use of visual imagery to promote hand hygiene are
forms of “nudges” (see our July 7,
2009 Patient Safety Tip of the Week “Nudge:
Small Changes, Big Impacts”). In
our April 2016 What's New in the Patient Safety World
column “Nudge:
An Example for Hand Hygiene”
we cited an article that showed location of hand sanitizers significantly
influenced their use by visitors (Hobbs
2016). The key finding was that when the hand sanitizers were placed in the
middle of the lobby (with limited
landmarks or barriers) visitors were 5.28 times more likely to use them.
So how about
locating hand sanitizers right on healthcare workers? Researchers at Darthmouth-Hitchcock Medical Center and UMass Memorial
Medical Center did just that (Koff
2016). They randomly assigned operating room environments to usual
intraoperative hand hygiene or to a personalized, body-worn hand hygiene
system. They found an 8-fold increase in anesthesia and circulating nurse
provider hand decontamination events above that of conventional wall-mounted
devices. However, use of the hand hygiene system was not associated with a
reduction in healthcare-associated infections.
Improving hand hygiene compliance rates remains a frustratingly
difficult endeavor in most healthcare facilities. But we can all learn from
successes elsewhere. Every little bit helps.
Some of our other
columns on handwashing and hand hygiene:
January 5, 2010
“How’s
Your Hand Hygiene?”
December 28, 2010 “HAI’s:
Looking In All The Wrong Places”
May 24, 2011 “Hand
Hygiene Resources”
October 2011 “Another
Unintended Consequence of Hand Hygiene Device?”
March 2012 “Smile…You’re
on Candid Camera”
August 2012 “Anesthesiology
and Surgical Infections”
October 2013 “HAI’s:
Costs, WHO Hand Hygiene, etc.”
November 18, 2014 “Handwashing
Fades at End of Shift, ?Smartwatch to the Rescue”
January 20, 2015 “He
Didn’t Wash His Hands After What!”
September 2015 “APIC’s
New Guide to Hand Hygiene Programs”
November 2015 “Hand
Hygiene: Paradoxical Solution?”
April 2016 “Nudge:
An Example for Hand Hygiene”
References:
APIC (Association for Professionals in Infection Control and
Epidemiology). The Hawthorne Effect hinders accurate hand hygiene observation,
study says. APIC News Release 2016; June 10, 2016
http://www.apic.org/For-Media/News-Releases/Article?id=d3702eac-c445-4641-9139-7d5545752905
Kovacs-Litman A, Wong K, Shojania KG, et al. Do physicians clean their hands?
Insights from a covert observational study. J Hosp
Med 2016; Early View 5 July 2016
http://onlinelibrary.wiley.com/doi/10.1002/jhm.2632/abstract
APIC (Association for Professionals in Infection Control and
Epidemiology). Seeing is believing: Visual triggers increase hand hygiene
compliance. APIC News Release 2016; June 9, 2016
http://www.apic.org/For-Media/News-Releases/Article?id=cfd082bd-7164-4f7c-ada7-6a6572885015
Hobbs MA, Robinson S, Neyens DM,
Steed C. Visitor characteristics and alcohol-based hand sanitizer dispenser
locations at the hospital entrance: Effect on visitor use rates.
Am J Infection Contol 2016;
44(3): 258-262
http://www.ajicjournal.org/article/S0196-6553%2815%2901158-X/abstract
Koff MD, Brown JR, Marshall EJ, et
al. Frequency of Hand Decontamination of Intraoperative Providers and Reduction
of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial
of a Novel Hand Hygiene System. Infect
Control Hosp Epidemiol
2016; 1-8 Published onlne June 7, 2016
Kelly JW, Blackhurst D, McAtee W, Steed C. Electronic hand hygiene monitoring as a
tool for reducing health care–associated methicillin-resistant Staphylococcus
aureus infection. Am J Infect Control 2016; Published
online: June 23, 2016
http://www.ajicjournal.org/article/S0196-6553(16)30340-6/pdf
Print “August
2016 Hand Hygiene: Who’s Watching? Does it Matter?”
We’ve done several columns (listed below) on the dangers of
home infusion therapy for cancer chemotherapy agents. In most cases the dangers
have arisen when an agent intended to be infused over several days is instead
infused over several hours, leading to toxicity and, in some cases, death.
But cancer chemotherapy is not the only type of home
infusion therapy that may be dangerous. ISMP Canada (ISMP
Canada 2016) recently did a column about a fatal case related to
intravenous vancomycin therapy in the home but their excellent recommendations
apply to almost any type of home infusion therapy.
The case described was a diabetic patient with a foot ulcer
who was receiving IV vancomycin at home after a hospital stay. Recommended
bloodwork, including trough vancomycin levels, was not done due to a faulty lab
requisition. The patient developed a rash, thrombocytopenia, and high serum
vancomycin levels as well as rising creatinine. He was rehospitalized
but despite IV fluids and platelet transfusions, he developed hypertensive
episodes, epistaxis and mental status changes and developed intracerebral
bleeding and ultimately died. The acute kidney injury was attributed to vancomycin
toxicity and the thrombocytopenia was also felt possibly related to the
vancomycin.
ISMP Canada makes recommendations that are appropriate not
only for home vancomycin infusions but also for any drug requiring therapeutic
drug monitoring. Good planning prior to discharge is critical. The prescriber
should decide whether an oral agent or an intravenous agent not requiring
therapeutic drug monitoring might be an alternative therapy. The team should
determine whether all the treatment and monitoring needs can, in fact, be met
with homecare (as opposed to followup in a hospital
ambulatory setting or continued inpatient admission). They should liaise with
the most responsible health care provider who will be responsible for ongoing monitoring
and assessment of the patient in the community prior to the patient’s discharge.
Copies of any laboratory requisitions and any special instructions should be
provided. Prescriptions and completed laboratory requisitions should be
provided and they recommend avoiding Friday bloodwork since results may be
delayed over weekends or holidays. Particularly important with potentially
nephrotoxic drugs like vancomycin is a review and possible adjustment of any
concomitant medications that might promote nephrotoxicity. The latest bloodwork
should be reviewed before administering each dose of the drug. In addition to
discussing the care plans with the home health agencies and/or community
pharmacists, it is important that the patient or family be educated on the
importance of getting the bloodwork done and what signs or symptoms should
raise concerns. Hospital pharmacists familiar with the therapeutic drug
monitoring should be part of the discharge team and may serve as the liaison
with community pharmacists where appropriate.
The article also has a link to ISMP Canada’s transitions
toolkit and checklist, a very valuable resource for facilitating safe
discharge of patients.
But what happens at home is not the only problem with home
infusion. ISMP (US) notes that home infusion therapies may also give rise to
problems when such patients are admitted to hospitals or emergency departments
(ISMP
2015). ISMP notes that patient safety can be jeopardized if the devices are
mishandled when filling, programming, attaching, and monitoring the pumps and
that the ambulatory pump marketplace is diverse, so the devices rarely have
standard components. Therefore, serious errors can occur when healthcare
providers are not familiar with these ambulatory pumps. The classic problematic
one is the insulin pump, as we’ve described in several columns, because the
vast majority of healthcare workers are not familiar with its use. Healthcare
workers may not know whether the pump is functioning properly nor how to get
replacement parts or batteries. There have also been cases where a physician
orders and a nurse gives a dose of insulin after a patient has administered a
dose without telling them. Every hospital should have a team headed by an
endocrinologist who can manage insulin pumps in the hospital. That may be a
challenge for rural hospitals, though use of telemedicine may help.
Our prior columns related to chemotherapy safety:
Some of our prior
columns on medication errors in other ambulatory settings:
June 12, 2007 “Medication-Related
Issues in Ambulatory Surgery”
August 14, 2007 “More
Medication-Related Issues in Ambulatory Surgery”
March 24, 2009 “Medication Errors in the OR”
October 16, 2007 “Radiology
as a Site at High-Risk for Medication Errors”
January 15, 2008 “Managing Dangerous Medications in the Elderly”
April 2010
“Medication
Incidents Related to Cancer Chemotherapy”
September 2010
“Beers
List and CPOE”
October 19, 2010 “Optimizing
Medications in the Elderly”
April 12, 2011 “Medication
Issues in the Ambulatory Setting”
June 2012 “Parents'
Math Ability Matters”
May 7, 2013 “Drug
Errors in the Home”
May 5, 2015 “Errors
with Oral Oncology Drugs”
September 15, 2015 “Another
Possible Good Use of a Checklist”
February 2016 “Avoiding
Methotrexate Errors”
April 19, 2016 “Independent
Double Checks and Oral Chemotherapy”
June 21, 2016 “Methotrexate
Errors in Australia”
References:
ISMP Canada. Gaps in Transition: Management of Intravenous
Vancomycin Therapy in the Home and Community Settings. ISMP Canada Safety
Bulletin 2016; 16(4): 1-5 June 28, 2016
https://www.ismp-canada.org/download/safetyBulletins/2016/ISMPCSB2016-04_Vancomycin.pdf
ISMP Canada. Hospital to Home - Facilitating Medication
Safety at Transitions. A Toolkit and Checklist for Healthcare Providers.
https://www.ismp-canada.org/transitions/
ISMP (Institute for
Safe Medication Practices). Ambulatory pump safety: Managing home
infusion patients admitted to the ED and hospital. ISMP Medication Safety
Alert! Acute Care Edition 2015; September 10, 2015
https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=118
Print “August
2016 Home Infusion Therapy Pitfalls”
Print “August
2016 What's New in the Patient Safety World (full
column)”
Print “August
2016 Guideline Update for Pediatric Sedation”
Print “August
2016 Some Reassurance on Antibiotic Stewardship”
Print “August
2016 Hand Hygiene: Who’s Watching? Does it Matter?”
Print “August
2016 Home Infusion Therapy Pitfalls”
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