Transcript see attachments - Keeping Kidney Patients Safe

Ensuring Safety in the Dialysis Realm
A medical director’s odyssey and
perspective
Paul E. Miller, MD
Definition of Patient Safety
• ‘Patient Safety: Freedom from accidental injury
stemming from the processes of health care. These
events include “errors,” “deviations,” and “accidents.”
Safety emerges from the interaction of the
components of the system; it does not reside in a
person, device or department. Improving safety
depends on learning how safety emerges from the
interactions of the components and processes that
minimize the likelihood of errors and maximize the
likelihood of intercepting them when they occur.
Patient safety is a subset of healthcare quality.’
• Quoted from the National ESRD Patient Safety Initiative
12/01/2001
“All that is great is simple”
J.w. von Goethe
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For nearly two decades I have observed repeat safety failures in diverse dialysis settings.
Since there is no magic bullet or panacea to assure enduring safety in dialysis, team commitment to harm
prevention for the entirety of every treatment is essential to mitigate safety failures.
Since the profession has not adequately shared working practical solutions, each safety team must create its own
strategy (often times with insufficient tools)—simplifying processes, closing safety gaps, and chipping away at
pervasive attitudes that impede patient safety.
P&Ps, however, are not pixie dust magical remedies to safety problems. Ingraining habits that always consider
patient safety is more meaningful (and less risky regarding liability) than dictating every action in dialysis through
complex and voluminous P&Ps (that dictate rather than guide actions)—especially considering high staff turnover
in dialysis.
Presented, from the vault of violations, is a compilation of humbling failure observations and experiences,
educational ideas, safety projects, perspectives and lessons learned.
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CAUTION: changing one aspect of a process may require adjustment elsewhere. It is important to consider the
“what if” scenarios and monitor the effects of changes. This information cannot be used as a substitute for
individualization of patient care by an appropriate prescriber. This is for information sharing purposes only.
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“What are we to do when the irresistible force of the need to offer clinical advice meets with the immovable
object of flawed evidence? All we can do is our best: give the advice, but alert the advisees to the flaws in the
evidence on which it is based.”
From the Oxford Center for Evidence Based Medicine http://www.cebm.net/?o=1025 Grades & Levels of Evidence
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MISSED: Missed Incidences of
Signals of Safety Explored in Dialysis
Cracking the code to prevent failure
mode
Paul E. Miller, MD
The Mystery
• Why were patients falling, bleeding, dying?
• Why were patients being transported to
emergency rooms from dialysis?
• Why were patients experiencing intolerance to
dialysis?
• Why wasn’t the MD notified of safety failures?
• Why couldn’t staff consistently execute
prescriptions as intended?
• Why were we failing to consistently protect
patients from harm?
Discovery Process
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Audits: reviewed safety practices, staffing characteristics and other aspects of care
and management—staffing ratios, experience and workflows
Reviewed: different protocols; frequency of rounding by nurse manager, medical
director, physician prescriber vs non-physician prescribers; frequency of vitals and
station visits; average clinic delivered time of dialysis; complexity of dialysis
prescriptions; formulary size; options for dialyzers and antibiotics; characteristics
including cost per treatment and days of dialysis operation
Collected on call questions & observations of failures in different settings
Analyzed the discrepancy in the frequency of failures with what was reported
Reviewed incenter labs and orders including post dialysis emergency room
encounters
Reviewed missed patient (SOS)—signals of safety
Observed dialysis patient care in acute, chronic and continuum of care encounters
Collected tips from patients, staff, and prescribers
Reviewed incidents, access complications, transitions to emergency rooms, cross
coverage calls, emails to staff and administration, and other reported concerns
Observations
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Set and forget attitudes included waiting for failure to respond—waiting for machine alarms to react to patient status.
RNs were assessing before and after and might only visit during dialysis to administer medications or respond to
problems.
Lack of: direction for safety limits including boundaries for safe care such as ulftrafiltration rate and total fluid removal
limits, minimum time prescriptions, prescribing limits for electrolytes, medication ceiling limits for ESAs, heparin, etc.
Technicians were handling things by traditional routine react and respond.
Lack of: recording & trending wrongfully suggested uneventful dialysis; simple visual reminders such as escalation
protocols; ingrained habits for detailed systematic approaches to patient safety at the chair side
Inconsistent escalation efforts; lack of checklists and algorithms for systematic approaches (beginning, end of day, before,
during, and after dialysis, problem oriented, etc)
Repeat failure episodes due to lack of effective problem solving and resolution assurance. Failure to consistently deliver
or execute prescriptions as intended by the prescriber: lack of attention to detail; unapproved adjustments to machines,
dialysis prescriptions (Rx), and knee-jerk dry weight changes were made on whims by staff (and patients).
Knee-jerk antibiotic usage: rampant, unnecessary, and without attending MD notification or follow-up
RN or nurse manager wrote admission/transient Rx without prescriber involvement
Kt/V, URR values were often misinterpreted by patients & staff leading to knee-jerk reactions: shortening time, dialyzer
size escalation, & incorrect advice from staff
Pause, interrupted or Stop Therapies: air alarm failures and loss of blood in clotted circuits were rampant with improper
set ups, access complications, and saline bags emptying. Multiple alarm resettings occurred for stop, pause, air
detection, venous, conductivity, critical or other alarms without appropriate timely escalation
Recurrent unexplained stop therapies caused by patient intentional clamping of blood lines underneath blankets
Observations
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Fall Risks: door stops, trash cans, and other obstructions in walk path; machine leakage and liquids on floor not
timely addressed; staff not escorting patients appropriately
Antibiotics, labs, diagnostic and other procedures were ordered by non-credentialed MDs and were not followed
up or approved by credentialed prescribers—lack of follow-up for complaints, problems, post dialysis events,
procedures, referrals and diagnostic tests. Use of electronic calendar for reminders was non existent.
Errors in dosing of Vancomycin & other antibiotics (abx) were common. Too little/too much without antibiotic
protocol oversight by hospital pharmacy services & incenter monitoring; prescriber cross-coverage errors
increased the failure rates of antibiotic dosing. Patients who received antibiotics in outpatient dialysis centers
received additional dosing once presenting to emergency rooms same day or different day of dialysis (reasons:
insufficient communication with no access to timely patient portal information or dialysis treatment encounter
forms; rush to administer abx in emergency room settings for time tracking)—efforts to improve communication
and reduce errors included handing patients a copy of treatment sheets with abx details and notifying ER if
patients were transitioning to ER from dialysis.
Staff used clotting substances from lab blood test tubes to promote hemostasis for access bleeding
Medication administration such as Vancomycin and IV iron were being administered without any flow rate
regulators and not according to safe time requirements—hypotensive episodes were occurring.
BP cuffs not appropriately fitted leading to inaccurate readings
Staff searched for orders to reduce HD time on evening shifts anticipating delays in NH or other transportation
services. Occasionally, staff waited for on call prescriber (unfamiliar with patients) to solicit a desired order that
differed from attending of record. These orders were often missed by attending through electronic order entry
that did not require co-signatures of attending (examples: allowing catheter lock with tissue plasminogen
activator [tPA] to remain until return to dialysis; shortening of dialysis; exceeding max UFR; allowing high sodium
concentration profiling)
Staff essentially encouraged sign off behavior by placing AMA/sign off forms at beginning of dialysis for patient
signatures designating the time desired for termination of dialysis
Observations
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Hemodynamics and intradialytic morbid events (IMEs): rescue saline administration, interrupted therapies,
cramps, hypotension, n/v, post dialysis episodes of care for emergency room visits, and other actions and
findings often considered as surrogates of patient clinical intolerance were not accurately reported or trended.
If captured, event description (severity, # episodes during same treatment) were not meaningfully trended.
Blood loss: clotted systems and dialyzers and post venipuncture bleeding episodes were common; there was a
lack of identifying, monitoring and escalating concerns for at risk bleeding patients with multiple blood thinners
or those exhibiting easy bruising and bleeding; failure to adequately secure lines including repositioning of
needles; clamps being used inappropriately on the visually impaired and others with contraindications
The perception of “safe in dialysis” was not realistic for staff nor consistent with the perceptions by the patients
they were serving
Process failure for identifying, escalating, and recording of adverse events and near misses led to inaccurate
reporting and reduced effectiveness of QAPI.
Antiquated data analysis and reporting contributed to safety failures. Failures of timely reporting episodes of
care were concerning.
Traditional and newly identified barriers that impede safety efforts were identified.
RNs, nurse managers failed to accompany rounding prescribers.
Transitions such as admits to rehab, NH, LTAC facilities: dialysis and other needs were missed for days
Newly designed safety projects by medical director were slow to move through the creeping committee process
Blood volume monitoring device effectiveness was reduced by inadequate monitoring and focus
Harm from unnecessary lower extremity arterial procedures in asymptomatic patients
Tourniquets for cannulation commonly misused and forgotten in place
Observations
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Angioaccess: HD access referral and catheter removal delays
Transient care and on-call coverage decisions were inconsistent and often not reported to
attending of record. Orders from on-call prescribers were not readily available to review (as
with co-signature orders) once electronic records started. No easily viewable longitudinal
charting existed (of a patient’s specific outstanding problems “to do list” for MD or others to
review at time of patient encounter or clinical review). Despite progress notes having
structure for effective systematic approaches as creatively designed for problem capture by
IT (problem oriented medical records), MDs, staff were not using SOAP notes appropriately.
Assessing care upon return to dialysis was inconsistent.
Advanced directives and resuscitative discussions were not consistently being delivered, and
not being discussed by attendings frequently enough especially for those patients in declining
health. Imminent safety failures for those unfortunate, yet, inevitable declining health
individuals were not timely addressed.
Admission of patients without medical director review led to inappropriate admissions of
high acuity patients that could not safely be treated in the outpatient dialysis settings. This
often consumed staff time for higher care attention needs in already challenging evening
shifts. Infectious transmission risks were concerning. Several patients were comfort care
appropriate and were not presented with those options prior to admission.
Formularies in hospitals and outpatient centers often times excluded nephrologist and
medical director involvement in the selection and safety surveillance processes.
Observations
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QAPI was sloppy. Some team members were quick to sabotage improvement projects using
misleading and inaccurate data. 4 hour minimum prescription led to reduced attempts at gaming
the system on lab testing days (treatments)—traditional efforts to convince patients to stay longer
just to make it appear that we were achieving goals
Abuse of medications such as IV anti-emetics and antihistamines: use not trended for quality and
safety analysis
GI preps not safely administered to patients including magnesium and phosphate-based
Complex mix and match prescriptions—changing dialysates at different hours
Hospitals refused to allow certain notification, admit, prn and transition standing orders because of
liability reasons—nurses could not adhere to requirements of lab notifications for critical labs
When standing orders were adopted by hospitals for dialysis patients and appropriate timely
communication with nephrology occurred, less chances for harm resulted: volume management;
medication reconciliation; missed dialysis; electrolyte imbalance; timely antibiotic administration;
and less unnecessary testing and procedures
Coordinating care in communities counts: emergency rooms often mismanaged dialysis patients—
early nephrology communication and direction reduced harm; we encouraged ER (and for any
transition in care) to call nephrology for immediate communication upon presentation
Focus fatigue and alarm fatigue were disturbing. “Going through the motions” was problematic
Observations
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Direct admissions often led to dangerous delays: patients not monitored safely, not receiving
antibiotics, dialysis or other care timely. Formulary options for rapidly administered antibiotics at
dialysis clinics were encouraged (prior to ER transfer for unstable septic appearing patients who
were not tolerating dialysis) instead of waiting hours to receive after leaving dialysis
Emergency room visits where patients were transferred directly to inpatient dialysis in hospital
prior to receiving RN assessment: failure to timely notify nephrology and on call dialysis nurse
immediately from ER led to dangerous delays; hand offs lacked effectiveness and urgent orders
were not timely acted upon (including abx) until hours later when patients transitioned from acute
dialysis to hospital rooms; patients were often assumed to be safe enough for dialysis in the
hospital dialysis acute program center hoping that their condition would improve after tx—
occasionally, patients were too unstable for the level of care that could be safely supported with
the dialysis staffing ratios
Emergency room and hospital staff failures when accessing PD and HD catheters: inadequate
infection control; high chest PD catheters accessed as HD catheters
Bladder indwelling catheters placed in anuric dialysis patients risked trauma and infections
Dialysis therapies in ICU settings: partially trained ICU staff led to safety failures
Parathyroid surgical patients: calcium carbonate dosing—prevention of constipation and alkalosis
monitoring required adjustment of prescription and increased stool softener approaches; holding
cinacalcet 1 week prior to sx
Attention to optimal volume status each treatment was lacking—failure to escalate, challenge,
adjust and record
Observations
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Patients were not adequately prepared prior to surgical procedures (example:
parathyroidectomy—cinacalcet not held or blood thinners) and attendings were
not aware of scheduled procedures
RN ramping of dialyzer size without prescriber input was problematic
Non-RN technicians were preparing and administering anticoagulation through
circuit
Aggregation of staff away from patients on treatment floor was problematic
LTAC patients in the outpatient setting were often unstable as well as infected
with multi-resistant organisms
Lab: errors, notification protocols, and validation methods were concerning;
(same color cap for test tubes for hemoglobin also for clearances led to
collection, preparation and lab analysis errors)
Testing of hemoglobins (Hgb) in volume excess states resulted in falsely low Hgb
levels, pseudo-resistant erythropoietin dx, and unnecessary ramping of ESA
dosing
Intravenous medication administration: infectious exposure risks (including
multi-use vial technique) and other safety concerns each dialysis
P&Ps were out of date, not practiced—just for show it seemed
Observations
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Large bore cannulation needle escalation caused greater bleeding episodes and trauma risks
Non-adherence for outpatient medications: sometimes ramping of doses resulted in problems when patients
decided to become more adherent—we transitioned more to oral observed therapy
Lack of ability to contact patients on call when notified by lab outside of dialysis clinic hours for bacteremia (or
other critical labs); uncertain if any treatment or appropriate treatment had been delivered
Back to back (two days in a row) dialysis did not consider dialysate prescriptions
Dialysis lines were crossing over patients and poorly secured for patient movement
Technicians and nurses were distracted: reading books, on phones, watching TV, gossiping, playing games
MDs would not respond timely to calls from units or conscientiously manage patient care
Infrequent or pass-through princess-waving prescriber rounds
Blood product transfusion practices were concerning; often, patients failed to show
Reuse processing and quality control were problematic
Blood draw and processing was problematic
Patients who should have stayed within close observation were allowed to be alone in waiting room prior to and
after dialysis
Medications such as aluminum based anti-ulcer therapies, metformin, and other contraindicated medications
were missed
More than one form of ESA in clinic resulted in mistakes when administered
Patients were allowed to leave treatment floor still holding accesses without verification of hemostasis
Observations
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Treatment sheets did not report verification of which dialysate, ultrafiltration or sodium profile administered
HD machine conductivity alarm ranges: tightening & more frequent validation reduced errors in delivery
No effective vascular access program including surveillance: AV access placement delays; excessive primary
failure rates
PD patients: missed signs for uremia and volume excess; non-adherence for treatments or self-administration of
ESAs and other medications; PD patients were stacking fluid.
Human factors errors were rampant
Pacemakers placed for hyperkalemia related reversible bradyarrhythmias, central lines, PICC lines, and
subclavian mediports placed compromising future dialysis access placement without nephrology involvement;
we educated CV and other surgeons, patients and others regarding preservation of patient pipelines for future
hemodialysis access
Efforts to transition patients faster from hospital settings to outpatient care have increased the episodes of care
resulting from patients too unstable and not medically suitable/optimized for return to outpatient dialysis.
Frequency of missed and incomplete dialysis sessions has increased with complex outpatient treatment plans
that included daily hyperbaric and other outpatient therapies—burden or scheduling conflicts that resulted in
patients deciding to skip or shorten dialysis.
Misconceptions from patients’ non-nephrology prescribers and emergency room physicians about the ability of
outpatient dialysis settings to safely care for unstable patients. There was a common misunderstanding that
outpatient dialysis clinics can easily manipulate dialysis schedules to handle such things as on demand dialysis
and daily dialysis for pericardial effusions; or, that every dialysis clinic has the ability to safely manhandle
severely obese mobility limited clients.
Prolonged outpatient hospital care for ARF dialysis patients led to increased errors as a result of fragmented
care without the continuity that exists in outpatient dialysis centers. Patients were cheated of quality care
especially with a lack of nephrology medical director oversight for acute dialysis programs. Patients
experienced hardships for travel which compromised employment and QoL.
Observations
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Manual transfer of handwritten treatment sheets to electronic documentation resulted in transcription
failures—subsequently, resulted in failures when treating staff did not recognize that post dialysis
weights were incorrectly entered and not detected; frequent inconsistent units of measure errors
Access complications and other episodes of care were being directed by “autopilot” protocols to
emergency rooms and interventional suites without MD involvement—this led to delayed definitive
access care and compromised catheter reduction and prevention strategies; sticking problematic
accesses; patients were not educated to protect future fistula routes or subclavian veins
Knee-jerk protocols (or orders by X-coverage MDs) changed dialysate baths without consideration for
lab errors or inconsistent lab results from usual patient labs—resulting in unintended management. The
effects of missed treatments and access complications were often not considered which may result in a
change from stable baseline labs—and usually do not warrant a change of stable prescriptions. Such
knee-jerk Rx changes risked prolonged exposure to patients until repeat testing; ramping of bicarbonate
was done without MD involvement and resulted in symptomatic alkalosis.
Missed signals of safety (trending and single signal abnormal lab results) resulted in response delays
Treatment sheets were being printed out prior to day of dialysis. Electronic prescribing protocol changes
and treatment sheet lab automatic population of results were sometimes missed. If internet system was
down, other patient information could also suffer gaps. We developed a clinic buddy system for faxing
over updated treatment sheets from another server region (which still was not a cure for major
outages).
Lack of updated identifying facial image (picture) corresponding to patient names on electronic records
increased the risk of confusion and communication mistakes by rounding prescribers and new team
members including during patient review conferences. Pictures of unstable patients as the image
changes over time on dialysis would have been beneficial for family patient conferences and advanced
directive discussions.
Observations
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Staff cut corners with access cleaning methods; infiltrations were rampant
Several medications were being missed as dangerously contraindicated or not followed closely enough for
monitoring levels or dose adjustment
Staff removed the tape securing access needles while high speed blood pumps ran which contributed to
infiltrations and blood loss episodes
Issues of concern were not being brought forward for timely escalation and were held until once a month QAPI
meetings for discussion. A lack of trending (including labs and IMEs) adversely affected problem solving
Repositioning of needles were done with insufficient consideration for infection control measures
Difficult access sticks: staff were sticking multiple times even on non-functioning accesses
Infiltrations of AV access as a result of faulty arm positioning (arms resting on arm rests of chair when body
positioning slumped lower in chair resulting in arm fatigue causing jerking of arm downward)
Dangerous medication ramping for heparin anticoagulation was being done without timely MD oversight &
without heparin Rx boundaries (missing recirculation access problems and early clotting of systems with air)
Laboratory results: delayed review by first line of defense clinic personnel and also prescriber; results often
misinterpreted as window in time results (not trending) and misstep actions occurred frequently. WBC and
platelet count changes often not captured
Problems with mathematical calculations for volume assessment and adjustments at machine level
Blood was not being returned when patients were disconnected from circuit for restroom breaks
RN initial assessment often did not occur until after first hour of dialysis; findings of no volume removal settings
even after long interdialytic periods for patients with no RRF was problematic
Patients who missed dialysis for several treatments were allowed to return to dialysis without assessment in
health status. When dialysis was missed for access or other reasons, MD was rarely contacted to assess urgency
and mitigate harm for those at most risk of sudden demise
Observations
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Disaster transient patients—unknown infectious status: machines not disinfected post treatment;
communication failures among outpatient facilities, ERs, and inpatient settings led to dangerously
prolonged waits for dialysis patients
Procedures: efforts to coordinate dialysis around procedures (not on same day) to avoid
complications were not a priority; often times, procedures were canceled as a result of not
receiving dialysis the day prior
Failed transplants—conversion to dialysis: immunosuppression not tapered timely
Anticoagulation: as patients were transitioned from catheter to AV access, reductions in heparin
were missed resulting in excess bleeding complications
Delays in prescribing ESAs, Iron and BMD treatment occurred—even when electronic dosing
protocols became available, enrolling new patients was delayed
Patients were receiving IV iron despite active infectious processes: IT team wisely responded with
automated intuitive actions that held IV iron dosing when infection suspected
RNs had more time to focus on patient care as e-Rx protocols & automated QAPI reports deployed.
Average use of ESAs reduced to < 2500 units/tx with e-Rx
Prescribers were able to focus on key quality trending parameters as IT data formats & autopopulation on treatment (Tx) sheets, encounter forms, and QAPI reports occurred
Refusal of some hospitals to establish nephrology safety and quality committees (and not having
quality nephrologist trained medical director oversight) led to inadequate quality improvement
efforts to augment community dialysis patient coordination of care
Observations
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Patients who were returning from hospitals and other encounters were often volume overloaded.
Accurate volume assessment and need for extra dialysis sessions within first week of return from
those transitions were missed resulting in repeat hospitalizations.
Optimal volume status assessment (dry weight) mismatching was widespread. Dry weights were
erroneously being adjusted for cramps without MD review; patients were becoming volume
overloaded—stacking fluid
Larger call groups: additional problems of not having consistency for who was being called to
report repeat failures. A lack of continuity presented challenges
Patient medicine and dialysis prescriptions were being renewed by RN without timely MD review
Early identification and isolation for preventing spread of contagious illnesses such as MRSA, VRE,
C. Diff, diarrhea and URIs were inconsistent.
Lack of complete commitment to excellence and safety in every action for every team member
Staff were transporting sharps several feet to reach containers
Inadequate dialysis: ultrafiltration only (dialysate bypass) therapies did not adhere to safe time
limits and boundaries; problematic dialysis was not escalated for immediate action to reduce
chances of harm from recirculating blood and hemoconcentration of electrolytes
Incenter stethoscope use ignored infection control practices especially for AV assessment
PD patients with unstable gait: large volume dwells risked fall harm during ambulation
Staff did not recognize the significance of change of patient status suggesting instability, or the
significance of when in dialysis events occurred (such as when IMEs occurred, early, mid, late or
post dialysis)
Observations
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Timely recognition, action, and follow-through beyond immediate problem solving to achieve sustained resolution and
prevention of recurrence were lacking.
Lack of communication throughout the team continuum; failure to immediately escalate concerns
Failure to follow P&Ps (ceilings; floors; limits; lack of systematic approaches using visual reminder aids)
Distractions (lack of focus on patient and task as hand)
Lack of staff and patient (overall team) training, engagement and commitment to the partnership for patient safety:
subsequent generation loss—critical gaps in training: technicians were training new nurses
Philosophies: that encourage reactive rather than proactive care approaches; that cheat patients of Time for the Dime;
that think of patients as out of sight, out of mind when they are not present in the facility
Lack of safe simplification of complex prescriptions & consolidation of standing orders led to recurring safety failure
events
Breaching safety thresholds with shock-and-awe treatments: electrolytes and solutes; volume assessment and rate of
removal; medication error and other exposure risks
Rogue prescribers and independent end-operator users and communication barriers including poor quality sound
transmission through cellular phones: failure opportunities without safe boundaries
Lack of prescribing oversight of non-experienced prescribers
On-call coverage failures for followup and inadequate information sharing
Too many options for medications, dialysates, standing orders and protocols for different prescribers; and therapies that
invite mistakes
Information sharing gaps: medications, compliance, and encounters or episodes of care. Perception of who is delegated
what role as prescribers across the continuum was a common cause of delays in treatment waiting on others rather than
handling in the facilities as was done in the past—medication prior-approvals added to that burden.
Reactive practices for disinfection of devices and water system waited for failures instead of preventing them
Unilateral administrative decisions regarding shortening supplies to 2 weeks became problematic for shortages and
disaster times
Observations
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Home program efforts initially were not fully supported & often discouraged by HD staff who feared
home growth would affect schedules and job security.
Some nurse managers avoided patient interaction and supervisory floor time by arriving late, hiding
in their offices most of the day, and leaving early. Clinics that had very engaged nurse managers on
the floor consistently performed better with less failure events.
Electrolytes were out of range from expected for patients presenting to emergency rooms after
dialysis representing mismatching of prescription to delivery of intended prescription.
Concerning lab results “ within range” were being missed regularly
With more than one dialysate buffer type bath and machines that defaulted to previous settings,
errors in delivery were rampant
Weekends and nights presented the most frequent episodes of care and safety failures: staff
inconsistency; lack of continuity; reduced MD, nurse manager and medical director presence; and
less staff experience contributed to the preventable failures. These shifts also had the highest at
risk patients.
Lack of adequate updated access to patient portal information
New patient education was inconsistent, drawn out, and without a systematic approach
Dips and spikes for anemia management—missing transfusions, ESAs stopped
Multiple alarm resetting occurred for stop/pause, air detection, venous, conductivity, critical or
other alarms: immediate escalation was inconsistent
Problem Solving and Practical Solutions
• Identify safety gaps, barriers, and research best practices
• Commonality regarding causal and contributing factors; execute
methods that maximize mitigation efforts for several hazards
• Refine surveillance and ongoing process improvement strategies:
select surrogates for clinical intolerance that are meaningful for
patient safety—short term and long term
• Reasoning and problem solving strategies: deductive reasoning,
inductive reasoning, question assumptions, reason by analogy
• Refining existing pathways, creating new algorithms, and simplifying
processes to improve safety and reduce errors in care
• Reducing extra steps that present extra risks of human error and
harm to patients: example—transitioned IV iron administration to
heparin pump which offered a non-FDA approved (albeit, well
studied for safety) approach for reducing the flow rate failures that
resulted in hypotensive episodes with IV iron
Barriers to improve safety
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Lack of awareness to the recurring safety failure problems: “Safe” perception that does not always consider harm
prevention, hemodynamic instability and clinical tolerance or intolerance
Lack of enough resources designated to IT and process improvement to add another project; no patient portal or
secured messaging system where all encounters could at least be partially captured and communicated
Patients, providers, prescribers, medical directors, administrators, and other team members including rogue
prescribers—traditional training and acceptance of mediocrity interfered with open mindedness for change
Failure to initiate, support, and sustain a culture-of-safety program at every level commensurate with ability
(including the utilization of electronic decision support, predictive analytics, and practical tools to assist the naked
eye as well as supporting a patient portal)
Patient engagement; recurring staff creep; staffing ratios & turnover; lack of adequate staff performance
Lack of safety certification training in dialysis; pervasive attitudes that corrupt effectiveness. Perception of value:
cost is too great for life saved—safety is not the priority.
Lack of a standardized safety and efficacy grading scale for scoring each dialysis session
No effective renal specific registry for adverse event reporting and failure analysis research
Top down administrative philosophies: marginalize medical director authority and involvement including selection
of devices and formulary; mandate governing body sign-off for safety programs that overrule/usurp MD—
perception that the governing body controls the safety process, not the medical director
Unprofessional competitive relationships that preclude non-medical director prescriber opinions and failure
observations from being taken seriously by staff
Lack of complete commitment to excellence and safety in every action
Insidious nature of dialysis safety failures preventing staff from perceiving adverse effects of actions
Medical directors and providers fear of losing patients by enforcing higher standards
Lab providers not executing e-alerts customized for prescriber preference and available to patients through
patient portals
Initial goals for safety improvement
identified
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Reduce the harm of hemodialysis: reduce intradialytic morbid events, improve patient perception &
clinical tolerance in dialysis (reduce intolerance)—prevent the shock-and-awe of therapies
Simplify prescriptions, consolidate protocols, prevent knee-jerk reactions, & reduce interrupted Tx’s
Re-educate staff to emphasize safe in every action, every step, all the time, all the way, throughout the
day—this involved reducing the distractions and improving the focus on patients
Crimp on Creep exhibited by staff over time; employ less Yes people and less minimalists
Set safety limits and boundaries for all aspects of care and ingrain the staff in the principles of safe
boundaries of care—(buoys and boundaries)
Improve the all eyes-on-patients and all hands-on-deck approaches especially during shift transitions
Improve communication within the clinic and beyond to outside encounters of care—reduce gaps
Reduce falls with the buddy system for escorting patients to and from stations
Reduce catheters; mitigate infection risks for button hole technique with extra steps of disinfection (and
avoidance of buttonhole technique at other unfamiliar locations such as at hospital, travel, or with
inexperienced personnel)
Consolidate medications, reduce excessive poly pharmacy, and identify categories of medications that may
pose additional risk to patients
Use proven e-prescribing protocols where possible to reduce human errors, delays, & time-to-treatment
Reduce blood loss episodes of care; educate patients about unnecessary procedures
Emphasize patient responsibility, home options, PD first and catheter last strategies
Early referral for education: new dialysis patient packet for systematic education and reduction in time for
action
Projects, Perils and Pearls
Clamp on Cramps in Dialysis:
Treading on Treacherous
Safety project to mitigate ischemic
injury in dialysis & reduce clinical
intolerance
Paul E. Miller, MD
Identified Need
• Patient discomfort and perception of QoL on dialysis
• Frequent cramps (prescribers were not aware) leading to excess
saline resuscitation and counteracting efforts to reduce sodium and
chloride loading (including avoidance of sodium profile variation or
modeling techniques)
• Prevention of intradialytic morbid events (IMEs)—cardiovascular
ischemic/instability events and patient harm caused by dialysis
therapies; often times, IMEs reoccurred during same treatment as
interventions did not focus on prevention/sustained resolution
• Increased sign-offs and no shows
• Missed mark for optimal volume status (dry weight) management
• Increased hospitalizations for volume overload
• Reduce factors such as cramps, shortened dialysis, and IV saline
administration which may adversely affect uremic acidosis
management
Strategy Summary
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SPOT-ON: Simplifying Prescriptions over Time
S^TOP: Safety at Top of the Hour RN Rounds
(PD first)—Home options Improve Patient Experience in Dialysis—(HO-i-PE)
Be Smart, Do Your Part—Health Begins at home Patient Engagement (dietary discretion emphasis)
e-ALERTS: Electronic Alerts for abnormal labs, episodes of care, return to dialysis, trending, and signals
of safety suggesting failures or impending doom in dialysis [proposed expansion of current safety alerts
system]
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SAFETY: Safety Assurances from Everyone Treating You—educational program
Developed new standard dialysate bath K 2.5, Mag 1.3—approach to reduce electrolyte shift risks
associated with longer therapies
Set boundaries—reduced HD alkali administration and administered oral bicarbonate daily therapies
Max BFR 400 and DFR 600, sodium (min 135, max 138), and UFR (max 10mL/Kg/Hour)
Minimum time on dialysis to 4 hours: Trading Time for Tolerance improved clinical tolerance of
Hemodialysis; allowed flexibility for increasing time through the Time Increase for Patient Safety
Standing orders
Dialysate temp 35; vitals monitored closely every 15 minutes and changes in trending escalated
Failure analysis of cramping episodes: identified cramps as early, mid, late and whether associated with
hypotension
30 day QAPI trending: cramps, hypotension, and UFR failures; each treatment shows UFR results
For the rare patient with unrelenting clinical intolerance—transitioned to PD if at all possible
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Results
• Dramatic improvement in clinical tolerance of dialysis and reduced
episodes of care
• Reduction in rescue saline use per treatment
• Improvement in lab values for patients
• Improvement in achieving optimal volume status
• Safety limit for total UF/hour (UFR at 10cc/hour/Kg) was objectively
monitored at each treatment and trended over time. Tickler with
maximum fluid removal was defaulted on each treatment sheet to
mitigate calculation errors and for those who have intolerance to
this rate (excessive large volume removals/hour or per treatment
for larger body size and other pertinent safety tickler information).
• Preventing knee-jerk dry weight adjustments and monitoring
leaving heavy were essential for reducing undesired consequences.
Extra treatment per month beneficial for some patients
SPOT-on:
Simplifying Prescriptions over Time
Safety project
Paul E. Miller, MD
Identified need and details
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Recurrent errors in executing therapies not as intended by prescriber
Knee-jerk reactions (changing of prescriptions) to labs that were problematic
Reduce ischemic episodes of care—to reduce harm and improve QOL post
treatments including TTR (time to recovery), we set all prescriptions at a minimum
of 4 hours and have the philosophy of “Get off the floor with 4”
Some patients sign-off; however, we have safely improved overall time on dialysis
4 hour minimum treatment prescription time (keep it low and slow); max BFR 400
(select BFR wisely if used above 400 as this resulted in worse patient symptoms).
Dialysate temperature lowering (standard 35)
Lower dialysate flow rate (DFR) 600 maximum: mitigated unexpected
ultrafiltration failures (resulting in IMEs, leaving heavy) using some dialysis
machines with higher DFRs
Oxygen therapy encouraged
Reduce BP medication use prior to HD and avoid certain classes such as nitrates
Once a month extra treatment offered to help reduce volume stacking and
consequences for those who are destined for self-destruction; staff have the
flexibility to increase time to safely remain within UFR limits
SPOT-on: Simplifying Prescriptions over Time
• Much more accuracy in what is prescribed (Rx) and what is delivered (dd)
• We individualize what we realistically can, consistently and safely, and
standardize what we can with similar scrutiny
• Simplified prescriptions, reduced need for extra human calculations and
adjustments; used lower (BFR, DFR, temperature, bicarbonate, sodium),
longer (Tx time), slower (UF rate), and higher (electrolyte concentration K,
Mag); administered oral bicarbonate therapy daily maintaining buffer
stores & reducing intradialytic shifts. Perceived clinical tolerance
improved as well as improved consistency of lab results.
• Default Rx: 2.25 Ca, 2.5 K+, 1.3 Mag; 35 temp—we avoid sodium variance
profiling or modeling
• Patients feel better with less episodes of care.
• Scheduling around increased times can be problematic for high volume
packed clinics. Anticipate more patients leaving heavy as maximum UFR is
lowered < 10cc/kg/hour if HD time is not increased sufficiently > 4 hours
SPOT-on: Simplifying Prescriptions over Time
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Every three months try two days in a row dialysis to assist with volume challenging
Daily stool softeners (unless loose stools) and sodium restriction
Encourage patients to lay back rather than sit up during treatments.
Frequent monitoring: symptoms, signs (15 minute vitals with set points for reducing BFRs and UFRs and
delta changes for HR & BP); recognize the symptoms and signs of impending doom (including new onset
cough, excessive yawning, dysphonia, ear fullness/ear popping pressure changes, HAs, n/v, cramping,
MS and visual changes, etc); set max UFR and total fluid removal limits; individualized ticklers for
patients with usual tolerance if < max UFR; increased time allowances as part of standing orders
Eating during and after (EAT—eat after treatment) is encouraged to help reduce the harm of electrolyte
and osmotic shifts
With the lengthened time and decreased heparin approach, we usually administer mid-treatment saline
infusion flush of (150 cc) especially if little intradialytic volume gained to ensure minimum ultrafiltration
rate. Anticoagulation has not been a problem with longer runs (non-reuse)
One size dialyzer: with longer times, we selected smaller dialyzer which may have been a factor that
helped reduce symptoms
Ultrafiltration profiling must be monitored closely: we discourage use other than linear to help prevent
errors in execution and prevent exceeding UFR if sign offs occur
Considerations for default 4 hour and
standard dialysate bath approaches
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Prescriber caution for excessive diuresis in patients with RRF & UOP resulting in potential increased sodium levels,
decreased Mag & K, and ICW-ECW shifts, which may worsen dialysis clinical intolerance. Patients may require added
interdialytic water and/or intradialytic volume to improve therapy tolerance and meet minimum ultrafiltration
requirements for machine and filter performance—reduce BFR, dialyzer size. Caution for ICW-ECW shifts with high
glucose levels.
Avoid larger dialyzers if able when time is increased (especially if BFR and DFR are ramped up) to help reduce rapid
osmotic and electrolyte shifts—consider using dialyzer escalation protocols or single dialyzer facility use.
Longer Tx duration may require lower bicarbonate, higher dialysate K and Mag (or liberalized dietary discretion and
supplementation/eating especially just prior to dialysis), lower BFRs and Na; nutritional status, frailty, dialysis vintage
RRF, and age, comorbid condition score, electrolytes, DM control, muscle mass and VoD should be considered
Anticoagulation: take it slow with ramping up since it has not been problematic. Our average heparin dose is < 2000
units/treatment (no reuse)
Comfort in chair: longer Tx times challenge patients; efforts to decrease discomfort using pillows under arms instead of
arm extensions on chair may reduce pause therapy episodes including needle dislodgement; pillows behind head and roll
pillows under ankles or knees while lying back in chair help with lower back complaints for some patients
Engage patients and family in any way possible for their therapies. Track sign off, early termination reasons—AMA form.
Require use of a calculator to help reduce errors
Increased surveillance revealed more reported episodes of care with cramps and hypotension until plan fully
implemented. Accurate trending over time including QoL perception, TTR, and clinical intolerance of therapy are
important for PI. Lower sodium may result in less tolerance if other factors are not adjusted accordingly.
Difficult challenges included convincing staff, patients and prescribers to avoid reducing time as Kt/V improved with the
increased time on dialysis.
Caution: rare opportunistic prescribers tried to advertise lower times and larger dialyzers to entice patients. We
overcame those conflicts through collaboration with nearby ethical medical directors, and by directly communicating the
safety reasons for increased time on dialysis with patients.
Pause & Interrupted Troubles, Stop Alarms &
Leaving Early Scenarios
• Efforts to reduce inadequate and inefficient
dialysis: reducing errors in set up; reducing
dialysis catheter temporary accesses and
access complications; reducing IMEs
S^TOP: Safety at Top of the Hour RN Rounds
Safety project
Paul E. Miller, MD
Identified need and details
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Missed opportunities to avert patient harm
S^TOP Check List
Escalation Procedures
Systematic Safety Surveillance of entire station
including patient and walk area environment
every visit to station by any staff member—
not just top of hour
• Hemodynamic trending and proactive changes
Findings
• Improved clinical tolerance and less hypotensive episodes.
Patients feel more secure with more focus on them.
• Accountability with oversight is needed to make sure staff
creep does not set in
• Harm prevention strategies for some patients will increase
leaving heavy occurrences and require extra therapies
• Checklists are great. However, too much information
overload distracts staff. The lists must be succinct, and
prompt staff at the point of care to remind them of the
critical thought processes. Our safety checks started out
with longer lists to train staff akin to training children how
to perform long division first.
OASIS
Systematic Dialysis Education Strategy
• Overview and Options (transplant, home, advanced
directives, etc)
Access—(ADAPT)
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• Support Services
• Individual Responsibility—(Priority in Patient
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Engagement Education)
Systems Education and Safety (Nutrition, Na, K, BMD,
volume, anemia, access care, fall prevention,
cardiovascular, immunizations and other prevention
strategies; Safety)
(HO-i-PE)
Home Options Improve Patient Experience with Dialysis
There’s Hope at Home in Dialysis
Paul E. Miller, MD
Home Dialysis Success
• In the beginning, we tried to expand home
dialysis offerings. It was challenging. As staff
ratios changed and expectations for excellence
with all the projects expanded, we ramped up our
efforts to initiate with PD or transition to home.
It has been a wonderful experience promoting
health, happiness, and independence at home
giving more hope to patients on dialysis. The
shifting towards home offset HD staffing ratio
concerns and staff turnover problems that risked
patient safety.
ASURE-CARE:
Assess Status Upon Return from Episodes of Care
Mitigate harm caused by gaps in information sharing
across the transitions of care and ensure readiness
for safe outpatient care
Paul E. Miller, MD
Identified need and details
• Admission of transient and other patients who were not stable or
appropriate for outpatient care
• Reduce re-hospitalization rates and information sharing gaps
• Prevent missed antibiotic dosing in transition and prescription
adjustments including anticoagulation and optimal volume status
• All patients called to prescriber and medical director for review
prior to admission—and prescriber upon first treatment for
validation of treatment prescription
• We have rigorous initial admission policy requirements. We needed
to treat each return to facility with similar scrutiny for risk
assessment and readiness to make sure we could meet mutually
agreeable realistic goals of therapy. Effective gate keeper strategies
were instituted and refined.
Information Sharing
• Each month, the big labs and a treatment sheet and encounter
summary note are transmitted to key providers for continuity of
care. Communication during transitions was improved by sending a
treatment sheet with prescription, medications, and key caution
in care ticklers to the areas of encounter at that time. Patients
were educated to always call us at the time of a new prescription
and remind us when presenting to the clinic for updates in care,
encounters, etc.
• If patients are admitted to a hospital, they are to call and ask the
clinic to participate in the coordination of care. We coordinated
with local emergency rooms to fax the encounter notes at the time
of ER discharge.
• IT has been great: Patient Portal is coming soon. For now, we
encourage patients to be engaged and keep with them the updated
information.
SAFETY: Safety Assurances from Everyone
Treating You
Team training to consider the
patient perspective
Paul E. Miller, MD
SAFETY: The Patient Perspective
• All team members are taught that safety is everyone’s
responsibility. Safety Assessments are everyone’s duty
including social workers and dieticians—all eyes on the
patient, station and surrounding environment.
• Behavior Based Safety (BBS) principles are emphasized
• Safety Assessments and Assurances from Everyone
Treating You it is what we want patients perceiving for
an improved sense of security, stronger trust in us
• Hazard Identification, Risk Assessment and Risk Control
• http://www.education.vic.gov.au/school/students/bey
ond/Pages/hazidentify.aspx
Safety Training
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Vitals every 15 minutes; specific direction regarding early recognition of impending
doom including changes/trending of vitals suggesting hemodynamic collapse.
Since the machines do not have adequate biofeedback reductions in ultrafiltration
and BFR, we had to pay closer attention to manually address these situations to
prevent ischemic harm to patients. Longer times on dialysis allowed us flexibility
in reducing BFRs and sodium.
Focus on task at hand: no longer were technicians allowed to do anything but
focus on patients and be present on floor directly engaged with patients rather
than performing non-direct patient care activities. We reduced distractions:
distractions are taught as that which leads to lack of focus—which results in
actions or inactions that kill. Adverse events, incidences, and near misses were
reviewed.
Revamped team safety training with safety checklists, safety rounds, and culture of
safety philosophies. Alarm resetting limits and escalation taught.
Caution-in-Care Ticklers added to each treatment sheet and carried over
Accountability at all levels was enforced.
Lab reviews required 6 month trending to mitigate missed signals of safety:
medical director trained staff regarding subtle changes to monitor
Problem Solving Strategies
• Categories of safety failures along the path to patient
add structure for team members on safety rounds
when using Problem Solving Strategies
• Hazard Risk Assessments
• Failure Analysis for devices and processes
• Event and fault tree analysis
• 5 Whys and What If analysis
• Root Cause Analysis
• Medical director reviews and approves all devices,
protocols, prn orders, processes, medications and
supplies to help reduce errors where possible
Guide for Medical Directors when
selecting devices in dialysis
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Does it improve safety and quality?
Does it mitigate extra human steps that are unfortunately required to make misaligned path-to-patient products and
processes safer?
Does it simplify the complexities that cause confusion and recurring safety breaches?
Does it align with all the other moving parts along the continuum of path to patient?
Does it support practical approaches that consistently achieve safe and quality care?
Is there a good plan of roll out, reliable surveillance and support to ensure consistent safe use?
How’s the manufacturer’s history of financial stability, training, retraining, reliability, integrity, response time, and service?
Is the device FDA approved and does AAMI have any specific caveat guidance regarding use?
What are the pros and cons of use? Is adequate training and ongoing support included?
Has there been enough use for the glitches and bugs to have been worked out?
How’s the device’s performance regarding downtime, recalls, reliability, warranty, maintenance, and support? What
upgrades are not included in basic support plans?
Is it cost effective?
Does it support superior and safe care for patients?
How does it differ from other devices in same class?
How long are you locked-in regarding the use of proprietary accessories to the device?
Are there other clinics in the region using the device, and what are their experiences with the device?
If accessories to device are needed, what are the delivery costs and details (especially if no nearby facilities use device)?
What unusual expertise is needed for maintenance and monitoring?
What disinfection type and schedule, if any, are required?
Are supply shortage risks for device accessories increased with no manufacturer competition?
Distractions Result in Actions that Kill
• Cellular phone and personal electronic device use
• Watching television; smoking breaks
• Staff aggregating at nurse’s station and away from floor
(losing focus and gaining distance)
• Speaking on phone while caring for patients
• Doing anything else rather than direct patient care actions
while patients are dialyzing including dialysis treatment
sheet computer entry, preparing set ups for next shift, and
educational modules
• Idle time is dangerous for staff…they need to be directed
for task completion; otherwise, attention failure will result
• Not monitoring closely, resulting in failure to recognize
early hemodynamic changes or signals—Focus Fatigue
FLARES
• We educated the staff to recognize impending doom, and act as flares for
early escalation and intervention.
• Focus (on the patient and the task at hand)
• Look/Listen (look at patient and station--not just the access-- then hone
in on the details; listen to patients as they breathe and as they speak
including what they are saying with their words and expressions)
• Ask/Acknowledge (ask how they feel, and acknowledge their needs and
complaints and monitor for symptom/sign improvement and resolution)
• Review/Record (review the prescription to ensure that it is being
delivered as intended; review trending hemodynamics for safety
parameters set by medical director and prescriber and record the review)
• Escalate as appropriate (alarms, concerns, questions, etc)
• Signal to patient with an empathetic kind smile; and if all ok a thumbs up;
and sign document/electronic signature of safety rounds
Recurring Safety Failures in the Acute
Dialysis Realm
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Lack of communication, nephrology oversight, nephrologist medical director,
appropriate procedures and following procedures
Missing the signals of safety
Optimal volume status—leaving heavy or new dry weight: not communicating with
HD center
Verbal prescriptions to non-dialysis nurses where errors in transcription and
bidirectional communication occur
Not validating prescription with MD at beginning of dialysis each session and not
notifying prescriber for any problems occurring with the session or reminding at
subsequent sessions to mitigate repeat failures
Failure to use adequate infection control techniques and proper button hole
techniques
Insufficient dialysis
Dialyzing patients in the extreme zones: severely elevated glucose levels to
“normalize” the labs not considering ICW-ECW shifts and status; severe acidosis
not considering total body electrolytes, effects of rapid acidosis correction, &
dialysate Rx selection
STOP-BLEED
Steps to overcome patient blood
loss episodes emerging from dialysis
Paul E. Miller, MD
Blood loss risks and considerations
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Thrombocytopenia—some clinics do not check platelets often and miss the rare, but serious
condition
Significant Bruising and Oozing: missing the opportunity to limit anticoagulation
Catheter ports: > 1,000 units/mL heparin increases risks of problematic systemic exposure
complications; during catheter placement and other surgical procedures or encounters, anesthesia
or other personnel commonly use the catheter and push prior to aspiration and instill higher
concentration of heparin for catheter locks
Failure to monitor reasons for oral anticoagulation and desired INR levels
Catheters and problematic AV access resulting in recirculation and early system clotting
Large bore dialysis cannulation needles; increased angle of needle to skin
Lost blood in circuits: recirculating too long without returning blood and not timely recognizing or
escalating for impending system clotting—(e.g., repeat alarms resetting; too much time spent
repositioning needles or withdrawing air bubbles from chamber; incorrect setups with excessive air
introduced in dialyzer and early clotting of system; interrupted or disconnected for other reasons
such as bathroom visits)
Dialyzing patients on same day as procedures including catheter insertion
Leg grafts and other accesses that are not held long enough post needle removal: when patients
advance pressure by using limbs, bleeding may initiate and not be recognized until much later
especially if leakage is underneath the skin. Chest or necklace grafts should be monitored for
bleeding risks closely.
Catheters: non-tunneled or non-secured catheters and thrombolytic catheter lock dwells
Blood Loss Mitigation Strategies
• Reduce Heparin (catheter concentration and intradialytic): heparin dosing
reviewed each month; above 5,000 units/treatment must be approved by
medical director
• Appropriate button hole technique
• Observe bleeding tendencies
• Review appropriateness of multiple blood thinner co-administration
• Avoid: unnecessary large bore cannulation needles, unstable positioning
of access arms & taping techniques, and inexperienced stickers for new or
tenuous accesses
• Avoid catheters and avoid dialysis on day of procedures
• Return blood early rather than repeat resetting of alarms on machines—
early escalation
• Educate and practice with patients regarding what to do for blood loss
episodes including stopping dialysis, holding sites, & post dialysis at home
Blood Loss Mitigation Considerations
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Too much heparin initiated from traditional beliefs and practices regarding
clearances and heparin (reuse/nonreuse)
Heparin not timely reduced when patients are receiving other meds such as
coumadin, antiplatelet or other "blood thinners”
Not reduced when patient changes from catheter to permanent access
Not reduced when patients have falls, procedures, hematomas or other
predisposing events or conditions
Inappropriate heparin ramping without physician input as a result of early clotting
of filters related to access recirculation or other access problems; heparin dose
increases and rarely decreases
Heparin dosing by nursing staff without safe boundaries, evidence-based
approaches, or quality assurance monitoring
Heparin is not adjusted for platelet count and easy bruising conditions, slow
hemostasis conditions, or for patients with GI or other bleeding risks
Recognizing clues that suggest acute blood loss for early mitigation efforts: ESA
dose above usual for 6 month average for patient; sudden drop in hemoglobin; or
new onset dark stools
Blood thinner use that is contraindicated for kidney failure patients
Securing Initial, Repositioned, and Exiting Needles
and other tips
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Observe for problems with tape not adhering or needle backing out: patient must be monitored closely—tracking
and recording efforts during remaining treatment
Warning signs must be escalated & problems safely and confidently resolved (not just over 1-2 minutes)
Efforts must be made to clear the surface of skin of any substance that is preventing the tape from adequately
adhering or interfering with needle positioning such as clothes or obstacles pulling on the needle, lines, or tape.
Once tape is removed, new tape for securing is required.
BFR must be reduced below 300 until the close monitoring is done and a gradual ramping to prescribed goal is
done in a safe and closely monitored manner over the next 1/2 hour.
If a needle has to be repositioned for backing out, escalate to nurse.
Caution with positioning of needles with larger angles to skin for deep tracking accesses and large limbs: these
are challenging to secure and may offer greater risk of dislodgement and access wall injury—escalate for
consideration for access revision and longer needle use.
No patient can hide their access at any time during dialysis.
Two needle sites simultaneously held by patients can lead to blood loss episodes. Two clamps at one time can be
unsafe especially for patients with visual impairment, frail, physically or mentally challenged (who may not be
suitable for holding or monitoring their own sticks). Clamps may present problems, and may not be used safely
for certain challenged patients.
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Experiencing a needle dislodgement leaves a lasting impression like a red SIREN screaming in the night.
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Resources:
http://www.edtnaerca.org/pdf/home/VNDpaper.pdf
Van Waeleghem J.P., Chamney M., Lindley E.J., Pancírová J. (2008). Venous needle dislodgement: how to minimise
the risks.
Journal of Renal Care 34(4), 163-168.
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Buoys, Boundaries, and Triggers in
Dialysis
Safety project: safe limits and escalation
protocols
Paul E. Miller, MD
Prompts and Reminders
• Placards laminated near station for rapid view
of parameters and escalation algorithms
• Prescribing limits
• Lab limits (parameters and delta changes),
and other aspects of care—boundaries and
guides for escalation
• Simple question or image poster prompt at
the scale for patients and staff
Angioaccess Intervention Management: AIM higher
ADAPT: Approaching Dialysis—Access Planning and Timing
Access management philosophies
for established and new patients
Paul E. Miller, MD
Race-to-Place
• Efforts to reduce HD catheter exposure time that
focus on shortening the time to effective
permanent access placement.
• Asking vascular surgeons to consider placing
patients on “stand-by” for canceled
appointments and surgeries to reduce time to
placement (often, surgeons feel no rush to place
AV accesses if patients are dialyzing successfully
with HD catheters; most surgeons do not
perceive the time of exposure failure risk of HD
catheters)
Avoid Vancomycin Overuse in Dialysis: AVOiD
Reduce antibiotic use in dialysis
Paul E. Miller, MD
Identified need and details
• Vancomycin use was problematic.
• Prescribed on whims; procedural MDs wanted the clinics to deliver
Vancomycin for everything including every post access intervention
• All Vancomycin prescriptions now have to be approved by medical
director. Oral trimethoprim/sulfamethoxazole is available for iffy
circumstances until next day review by MD if appropriate. Some
iffy circumstances include post dialysis access placement with
warm, red and swollen limbs or erythema surrounding exit site of
dialysis catheter
• As a result of low catheter rates (and avoidance of chronic infected
limb or chronic infected device antibiotic incenter treatment), we
go months without Vancomycin antibiotic administration.
Reducing Buttonhole Infections
Extra Step to Disinfect and Protect
Paul E. Miller, MD
Identified need and details
• Increased concern over infections
• Extra steps to disinfect and protect have
proven very effective at preventing infections
• Button hole procedures have been very
beneficial in our clinics with reduced
infiltrations, blood loss episodes, discomfort
and intolerance.
Managing Acidosis in Dialysis: MAiD Easy
Safety project using oral bicarbonate
and setting dialysis alkali dosing limits
Paul E. Miller, MD
Identified need, details and outcomes
• Higher machine settings for bicarbonate were not
achieving quality and safety goals. There was
often a mismatch of executed therapy and
intended prescription.
• Lab preparation techniques and testing were
problematic
• We initiated oral bicarbonate therapy and set
limits for maximum machine setting for
bicarbonate. The oral bicarbonate therapy is well
tolerated and helps reduce hyperkalemia
episodes.
Tale at the Scale
Listening to each patient’s story
Paul E. Miller, MD
Identified need and details
• Tell your tale at the scale is an educational
promotion to patients and staff to help reduce
information sharing gaps—information that
helps reduce safety failures such as missing
falls and blood loss episodes, patient
intolerance of dialysis, preferences and
concerns, medication changes, contagious
conditions, medical encounters, and
symptoms.
Dose After Dialysis
Capturing Events and Responding to
Recovery after Dialysis
Paul E. Miller, MD
Identified need and details
• Dose after dialysis started as a reminder to
capture experiences and events of patients
during and after dialysis. It later migrated into an
educational reminder to monitor the carry-over
effects or hangover after dialysis—the
perceptions of patients regarding time to
recovery to determine if their dosing of dialysis
needed improvement. With lengthened times,
focus on maintaining near normalcy, nutritional
support, reduced UFRs, and overall efforts to
reduce shock and awe of therapies, time to
recovery (TTR) has improved.
Be Smart, Do Your Part
Health Begins at Home—Priority in
Patient Engagement Education
Paul E. Miller, MD
Identified need and details
• Patient responsibility in care: patients can improve health and
reduce safety complications—daily stool softeners, oral bicarbonate
and dietary discretion reduce risk of hyperkalemia and improve
safety in uremic acidosis management. Avoiding sodium and
aluminum are emphasized. We educate that sodium is not just
what patients pour, but what’s sought & bought from the store or
brought through their door.
• Fall prevention, dental and foot care
• Access care: placement, monitoring and cleaning
• Medication adherence, preventive care, immunizations
• Patient engagement reduces errors & improves satisfaction. MD
emphasizes the patient role in care and safety: cognizant of
prescriptions, machine settings, processes; alert for changes and
monitor as neighborhood watch for others on dialysis.
• Other areas of compliance (TT, skips, sign offs)
Proaction for PD Satisfaction:
Backup HD for PD
• Intermittent backup HD runs reduced
hospitalizations, improved volume status,
prolonged home therapy options for patients,
and improved QoL.
Suggested resources for stewards of
safety that should be readily available
– sample outpatient dialysis clinic prescription template with safe
prescribing parameters, standing & prn orders, boundaries and limits
– sample P&Ps
– sample e-alerts notification, parameters and triggers
– sample list of commonly missed signals of safety in dialysis
– sample: safety lists, escalation tools, and reporting process
– sample: progress note and encounter form with prepopulated sections
– Educational podcasts for topics such as adverse events & near misses
– Discharge Orders for Transition Safety—(Connecting the Dots)
– Validating Acute Prescription Orders Unburdening RN in Acute Dialysis
– Practical Prescribing Tools and Pearls in Dialysis: A guide for the prescriber
and nurse for acute and chronic settings
– Hospital emergency room, admission and prn Sample Order Sets
– Inpatient Dialysis Sample Order Set
Validating Acute Prescription Orders Unburdening RN
in Acute Dialysis
• Call to prescriber at each presentation for dialysis after patient
assessment. For ARF patients, structured assessment was
instituted to reduce risks of compromising renal recovery and
prolonging unnecessary exposure to central venous lines—this was
especially important for the circumstances where prescribers were
unfamiliar with patients
• Minimum prescription validation: duration; access and specifics—
BFR, needle size and type or catheter lock details including
concentration of heparin or other; anticoagulation type, amount if
any and frequency; flushes; total removal volume, UF and other
profiling, and maximum rate—max UFR; parameters for calling MD;
specifics regarding use of any BVM devices, prn medications,
oxygen, or cardiac monitoring; dialyzer size; DFR; dialysate
temperature; type of dialysate: electrolytes—sodium, magnesium,
potassium, bicarbonate; medication administration; treatment
sheet faxing to outpatient center if appropriate
Discharge Orders for Transition Safety
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Correspond with outpatient facility through phone and fax for updating health information. Nephrologist
updating of patient status must be communicated with outpatient dialysis
Fax all labs, imaging reports, operative reports, hemodynamic monitoring reports (graphics), consults, H&Ps, D/C
summaries, transfusion histories, culture reports, last two dialysis treatment sheets, last nephrology progress
notes, d/c medication reconciliation, d/c instructions and appointments, d/c orders
Weigh patient after each dialysis (standing if able) and fax the last weight upon discharge and last post dialysis
weight if different
If prescribed Coumadin or coumarin, notify patient and center of next lab draw and who is responsible for
monitoring outpatient INR/PT; and reason for use, duration of therapy, and desired goals of therapy
Notify outpatient facility of last HD treatment to reduce skip treatments during transitions with consideration for
next day dialysis
If a dialysis catheter is placed, outpatient vascular access surgical or PD appointment must be made; no temporary
non-tunneled dialysis catheters are accepted into facilities
If transitioning to NH, SNIF, Rehab, or LTAC, notify nephrologist and facility upon admission to those facilities to
assist with continuity of care
Provide patient with contact information for on-call nephrology need
Notify outpatient dialysis facility of need for antibiotics, course of therapy, and reasons.
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Suggested Resources:
Care Transitions and Network 4 Resources
“Hospital to Dialysis Unit Transfer Summary”
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Suggested Resources
• Care Transitions and Network 4 Resources
• “Hospital to Dialysis Unit Transfer Summary”
• Tools/resources for hospital discharge
planners within the Fistula First tools (sect L)
• http://www.network13.org/QI_Reports.php
Suggested Resources
• Method to Assess Treatment Choices for
Home Dialysis (MATCH-D)
• www.homedialysis.org/match-d
• CDC Dialysis Checklists
• 5 Diamond Patient Safety Program
Suggested Reading
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JANUARY 31, 2001
Collaborative Leadership for ESRD Patient Safety
Phase 1 Report of the National Patient Safety Consensus for the Community of Stakeholders in
End Stage Renal Disease
The Role of Medical Directors in Dialysis Facilities: Series Editor : Robert A. Gutman: The Dialysis
Medical Director’s Role in Quality and Safety
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Alan S Kliger The dialysis medical director's role in quality and safety. Seminars in
dialysis 2007;20(3):261-4. Patient safety in the dialysis facility. Blood purification 2006;24(1):1921.
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Maintaining Safety in the Dialysis Facility
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CJASN November 2014 CJN.08960914Patient and facility safety in hemodialysis: opportunities and
strategies to develop a culture of safety.
Renee Garrick, Alan Kliger, Beth Stefanchi
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Suggested Resources
• AHRQ Safety Program for End-Stage Renal
Disease Facilities – Toolkit
• ESRD Toolkit Modules:
• Creating a Culture of Safety
• Clinical Care
• Using Checklists and Audit Tools
• Patient and Family Engagement
Miscellaneous comments regarding
safety in dialysis
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No poka-yoke device or fail-safe process in dialysis; dialysis is not a machine, it is a process
Not always about P&P, manufacturer’s mechanical faux pas or a pending technological fix
Good judgment, less risks, safety threshold parameters & escalation protocols, & simplifying the process
from path to patient
Caring attitudes, behavioral routines, attention to detail—prevention strategies
Accountability at all stages from path to patient and at all encounters
Training safety and process improvement concepts including pattern recognition
Avoiding knee-jerk algorithms that react with regurgitation; setting limits on certain prescribing aspects;
requiring escalation and validation protocols
Recognizing ominous signals & changes in status that suggest impending doom can only mitigate safety
failures if appropriate responses to these signals of safety (patient SOS signals) are timely executed and
followed through
Engaging entire team including patients is essential to achieve enduring success
Partnering with lab provider and IT for meaningful adjunct tools for mitigating safety failures
Select practical approaches that prevent patient harm while using therapies that always pose risks
Measuring safety in dialysis can be challenging—especially if harm is not understood, events are not
captured, reported, accurately characterized, and appropriately depicted using visually friendly trending
formats. Monitoring intolerance to dialysis using carefully selected surrogate markers including patient
perception is important for safety teams.
There is no universally adopted safety grading scale or system in dialysis for safety scoring of each
dialysis session; therefore, an all-hazards harm prevention strategy must guide the stewards of safety.
Miscellaneous comments regarding
safety in dialysis
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The timeline for safety progress in dialysis is populated with many innovations. Despite the advances, preventable safety
failures echo as recurring themes because traditional reactive philosophies undermine safety-first proactive efforts.
Effective safety programs require medical director engagement and prescriber, patient and entire team buy-in. Acute
programs that are not supervised by quality nephrologist medical directors compromise the continuum of care and safety
efforts of the outpatient dialysis programs.
Holistic approaches are necessary for optimal care.
Patient or prescriber refusal should not prevent future safety discussions using different approaches
P&Ps are like disaster plans and need to be routinely practiced, critiqued, and updated
Expecting nurses to consistently execute complex Rx’s and juggle disparate clinic standing and prn orders is unrealistic.
Such complex care, if necessary, is best delivered at home or in hospital settings with one-on-one focus
Categories of safety failures are well described in literature. The industry, however, has not adequately shared problemsolving strategies for some of the most preventable repeat patient harm events. A broadened focus on the culture of
safety presents opportunities for the industry to share experiences, practical solutions, working examples of algorithms,
QAPI projects, and P&Ps in an effort to advance the safety discussion from theory to practice for every dialysis realm.
Signals of safety in dialysis are commonly missed. Failure to timely recognize and respond risks harm to patients. Failure
of pattern recognition with small clinic numbers may preclude effective QIP for certain situations.
Expanded reporting of near miss and hard hit occurrences is important. Few internal safety registries exist which could
offer practical insights from the collective experiences.
Advanced safety certification could be part of credentialing processes for clinic prescribers and medical directors
A safety scoring mechanism or scale for each dialysis session is needed. If the 5 star ratings program were safety based,
there would be less fluff, and a lot more meaningful stuff aiding the dialysis stewards of safety.
After all, how meaningful are measurements of dialysis quality and success without consideration for patient safety,
clinical tolerance and intolerance?
Safety in Dialysis
“It Don’t Come Easy”
Richard Starkey (Ringo Starr) and George Harrison