June 2017 Pennsylvania Patient Safety Advisorypatientsafety.pa.gov/ADVISORIES/Documents/201706_home.pdfJune 2017 PENNSYLVANIA PATIENT SAFETY ADVISORY REVIEWS & ANALYSES 45 Frequent

Produced by ECRI Institute

and ISMP under contract

to the Pennsylvania

Patient Safety Authority

Vol. 14, No. 2

June 2017

PENNSYLVANIAPATIENT SAFET Y ADVISORY

REVIEWS & ANALYSES

45 Frequent Monitoring and Behavioral Assessment: Keys to the Care of the Intoxicated PatientIntoxicated patients and those under the influence of alcohol, regardless of care setting, pose unique challenges to health-care providers. Assessment and management of these patients are key elements to the care and prevention of harm for the intoxicated patient.

55 Errors Originating in Hospital and Health-System Outpatient PharmaciesWhile a majority of prescriptions dispensed daily in outpatient pharmacies will be correct, errors are known to occur. Error reduction strategies can be implemented in multiple stages of the prescription filling process including during triage and order entry, production, and point-of-sale.

64 Bullying in Healthcare: A Disruptive Force Linked to Compromised Patient SafetyBullying or aggressive behaviors between healthcare provid-ers, such as verbal abuse and intimidation, can be a threat to safe patient care. Facilities can work to institute effective policies with leadership support, educate staff and managers to recognize and handle bullying situations, and involve medi-cal staff leadership.

FOCUS ON INFECTION PREVENTION

71 Retained Bioburden On Surgical Instruments After Reprocessing: Are We Just Scraping the Surface?The design of medical devices, equipment, and instru-ments can provide ideal spaces for bioburden accumulation and subsequent development of surface biofilms. A quality improvement initiative in surgical instrument reprocessing may help to combat bioburden prevalence.

DATA SNAPSHOT

76 Radiology Contrast Concerns: Reports of Extravasation and Allergic ReactionsContrast media is used as an advanced imaging technique to improve diagnosis, and is generally safe and effective. However, knowledge of adverse reactions, prevention, preparation, and adequate response when a reaction occurs are essential to providing safe care to patients undergoing contrast-related studies.

OTHER FEATURES

80 Bridging the Gap between Work-as-Imagined and Work-as-Done

84 Saves, System Improvements, and Safety-II

Page ii Vol. 14, No. 2—June 2017©2017 Pennsylvania Patient Safety Authority

Pennsylvania Patient Safety Advisory

PATIENT SAFETY AUTHORITYBoard of DirectorsRachel Levine, MD, ChairRadheshyam M. Agrawal, MDJan Boswinkel, MDJohn Bulger, DO, MBADaniel Glunk, MDArleen G. Kessler, PharmD, MBA, RPhMary Ellen Mannix, MRPEStanton Smullens, MD, FACSLinda Waddell, RN, MSN, CJCP, CPPSEric H. Weitz, Esq.

StaffRegina M. Hoffman, MBA, BSN, RN, CPPS, Executive DirectorMichelle Bell, BSN, RN, FISMP, CPPS,

Director of Outreach and EducationChristina Hunt, MBA, MSN, RN, HCM, CPPS,

Director of Collaborative ProgramsHoward Newstadt, JD, MBA, Finance Director/CIOMegan Shetterly, MS, RN, CPPS, Senior Patient Safety LiaisonJoAnn Adkins, BSN, RN, CIC, Infection Prevention AnalystJeffrey Bomboy, BS, RN, CPPS, Patient Safety LiaisonKelly R. Gipson, BSN, RN, CPPS, Patient Safety LiaisonRebecca Jones, MBA, BSN, RN, CPHRM, CPPS, Patient

Safety Liaison and Special Assistant to the Executive DirectorRichard Kundravi, BS, CPPS, Patient Safety LiaisonChristopher Mamrol, BSN, RN, Patient Safety LiaisonMelanie A. Motts, MEd, BSN, RN, CPPS, Patient Safety LiaisonCatherine M. Reynolds, DL, MJ, BSN, RN, Patient Safety

LiaisonTerri Lee Roberts, BSN, RN, CIC, FAPIC,

Infection Prevention AnalystAlex Ulsh, Systems Administrator, Deputy CISORobert Yonash, RN, CPPS, Patient Safety LiaisonTeresa Plesce, Office ManagerKaren McKinnon-Lipsett, Administrative SpecialistShelly M. Mixell, Executive Director Assistant

Contact Information333 Market Street, Lobby Level Harrisburg, PA 17101Telephone: 717-346-0469Fax: 717-346-1090Website: http://patientsafety.pa.govE-mail: [email protected]

PENNSYLVANIA PATIENT SAFETY ADVISORYEllen S. Deutsch, MD, MS, FACS, FAAP, CPPS, EditorJohn R. Clarke, MD, Editor EmeritusWilliam M. Marella, MBA, MMI, Program Director

AnalystsTheresa V. Arnold, DPM, Manager, Clinical AnalysisSharon Bradley, RN, CICJames Davis, MSN, RN, CCRN, CIC, FAPICMichelle Feil, MSN, RN, CPPSEdward Finley, BSMichael J. Gaunt, PharmDMatthew Grissinger, RPh, FISMP, FASCPMary C. Magee, MSN, RN, CPHQ, CPPSChristina Michalek, BSc Pharm, RPh, FASHPSusan C. Wallace, MPH, CPHRM

AdvisorsMichael Cohen, ScD, MS, RPh, President, ISMPRonni Solomon, JD, Executive Vice President

and General Counsel, ECRI InstituteAllen Vaida, PharmD, Executive Vice President, ISMP

Production StaffJesse Munn, MBA, Managing EditorJulia Barndt, MAEloise DeHaan, ELSSusan LaffertyDawn ThomasJohn Hall, Manager, Printing ServicesTara Kolb, BFA, Manager, Media ServicesKristin Finger, BSSuzanne R. GehrisBenjamin Pauldine, MS

Contact InformationMailing address: PO Box 706 Plymouth Meeting, PA 19462-0706Telephone: 866-316-1070Fax: 610-567-1114E-mail: [email protected]

Editorial Advisory BoardMary Blanco, MSN, RN, CPHQ, Quorum Health CorporationLawrence M. Borland, MD,

Children’s Hospital of Pittsburgh of UPMC Dorothy Borton, BSN, RN, CIC, Einstein Healthcare NetworkAlbert Bothe Jr., MD, Geisinger Health SystemMark E. Bruley, BS, CCE, ECRI InstituteVincent Cowell, MD, Temple UniversityFrank M. Ferrara, MD, MBA, Wills Eye Surgery Center-

Plymouth MeetingCaprice C. Greenberg, MD, MPH, University of Wisconsin

School of Medicine and Public HealthDaniel Haimowitz, MD, FACP, CMDMary T. Hofmann, MD, Abington Hospital—Jefferson HealthJanet Johnston, JD, MSN, RNSandra Kane-Gill, PharmD, MSc, FCCM, FCCP,

University of Pittsburgh School of PharmacyHarold S. Kaplan, MD, Mount Sinai School of Medicine Michael L. Kay, MD, Wills Eye Hospital, Thomas Jefferson

University Hospital, Pennsylvania HospitalJohn J. Kelly, MD, FACP, Abington Hospital—Jefferson HealthMichael Leonard, MD, Kaiser Permanente, Institute for

Healthcare ImprovementJames B. McClurken, MD, FACC, FCCP, FACS, Temple

UniversityPatrick J. McDonnell, PharmD, FASHP Temple University

School of PharmacyDwight McKayFrancine Miranda, BSN, RN, FASHRM, Lehigh Valley HospitalDona Molyneaux, PhD, RN, Gwynedd-Mercy CollegeGina Moore, BSN, RN, CPHQ, Christiana Care Health ServicesSteve D. Osborn, Vice President, Saint Vincent Health CenterChristopher M. Pezzi, MD, FACS, Abington Hospital—Jefferson

HealthEric Shelov, MD, Children's Hospital of Philadelphia,

University of PennsylvaniaDean Sittig, PhD, University of TexasAmy B. Smith, PhD, Lehigh Valley Health NetworkNielufar Varjavand, MD, Drexel UniversityDebra J. Verne, MPA, RN, CPHRM, Penn State

Milton S. Hershey Medical CenterLinda Waddell, MSN, RN, CPPS, CJCP, Donald D. Wolff, Jr.,

Center for Quality Improvement and Innovation at UPMC Harold C. Wiesenfeld, MD, University of PittsburghZane R. Wolf, PhD, RN, FAAN, LaSalle University

School of Nursing and Health Sciences

ACKNOWLEDGMENTSThese individuals reviewed articles for Vol. 14, No. 2:

Melissa Adams, MS, UPMC and Pinnacle Treatment CenterMary Jane Casey, MBA, Penn MedicineGail Horvath, MSN, RN, CNOR, CRCST, ECRI InstituteSandra Kane-Gill, PharmD, MSc, FCCM, FCCP, University

of Pittsburgh, School of PharmacySheila Kelly, MD, St. Mary Medical CenterGregory J. Nadolski II, MD, University of PennsylvaniaGrena Porto, RN, ARM, CPHRM, ESIS ProClaimHolly Ricke, RN-BC, Wellspan Health, York HospitalKaren Ryle, MS, RPh, Massachusetts General HospitalAmanda Sivek, PhD, ECRI InstituteAmy B. Smith, PhD, Lehigh Valley Health Network/ University

of South Florida Morsani College of MedicineRenee Thompson, DNP, RN, CMSRN, RTConnections, LLCAlan Wartenberg, MD, FACP, DFASAM

OBJECTIVEThe Pennsylvania Patient Safety Advisory provides timely original scientific evidence and reviews of scientific evidence that can be used by healthcare systems and providers to improve healthcare delivery systems and educate providers about safe healthcare practices. The emphasis is on problems reported to the Pennsylvania Patient Safety Authority, espe-cially those associated with a high combination of frequency, severity, and possibility of solution; novel problems and solutions; and problems in which urgent communication of information could have a significant impact on patient outcomes.

PUBLISHING INFORMATIONThe Pennsylvania Patient Safety Advisory (ISSN 1941-7144) is published quarterly, with periodic supplements, by the Pennsylvania Patient Safety Authority. This publication is produced by ECRI Institute and the Institute for Safe Medication Prac-tices under contract to the Authority.

COPYRIGHT 2017 BY THE PENNSYLVANIA PATIENT SAFETY AUTHORITYThis publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration, provided the source is clearly attributed.

Current and previous issues are available online at http://patientsafety.pa.gov.

SUBSCRIPTION INFORMATIONThis publication is disseminated by e-mail at no cost to the subscriber. To subscribe, go to http://visitor. constantcontact.com/d.jsp?m=1103390819542&p=oi.

INDEX INFORMATIONThe Pennsylvania Patient Safety Advisory is indexed in NLM Catalog (http://www.ncbi.nlm.nih.gov/nlmcatalog), a service of the US National Library of Medicine and National Institutes of Health.

The Advisory is also indexed in the CINAHL® Plus and CINAHL Plus with Full Text databases.

CONTINUING EDUCATIONThe Pennsylvania Patient Safety Authority works with the Pennsylvania Medical Society to offer AMA PRA Category 1 Credits™ for selected portions of the Pennsylvania Patient Safety Advisory through the online publication Studies in Patient Safety. Go to http://www.pamedsoc.org to find out more about patient safety continuing medical education opportunities.

The Authority also works with the Pennsylvania State Nurses Association to offer nursing continuing educa-tion credits for selected portions of the Advisory. Go to https://ce.psna.org/continue-education/courses/ to view the course catalog.

CONSIDERATION OF SUBMITTED MANUSCRIPTSManuscripts consistent with the objectives of the Pennsylvania Patient Safety Advisory are welcome. For information and guidance about submission and instructions for authors, please contact the editor.

Scan this code with your mobile device’s QR reader to subscribe to receive the Advisory for free.

Pennsylvania Patient Safety AdvisoryVol. 14, No. 2—June 2017©2017 Pennsylvania Patient Safety Authority

Page 45

Frequent Monitoring and Behavioral Assessment: Keys to the Care of the Intoxicated Patient

Mary C. Magee, MSN, RN, CPHQ, CPPS Senior Patient Safety/Quality Analyst Pennsylvania Patient Safety Authority

Timothy Horine, BSN, RN Staff Nurse, Neuro-Cardiac ICU

Main Line Health-Bryn Mawr Hospital

INTRODUCTION

Intoxicated patients and those under the influence of alcohol, regardless of care setting, pose unique challenges to healthcare providers, who must manage patient aggression, gain cooperation with treatments, and monitor the patient for changes in condition, including gradual or acute deterioration.

The World Health Organization (WHO) estimates that 38.3% of the world’s popula-tion drinks alcohol. Individuals older than 15 years drink 6.2 liters on average per year, and globally, harmful use of alcohol causes about 3.3 million (5.9%) deaths every year.1 Two-thirds of American adults consume alcohol, up to 10% abuse it, and acute intoxication is associated with traffic accidents, domestic violence, homicide, and sui-cide.2 A 2014 survey conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA) noted that “24.7% of people ages 18 or older reported that they engaged in binge drinking* in the past month; 6.7% reported they engaged in heavy drinking in the past month.”4 In the United States, it is estimated that more than 600,000 emergency department (ED) visits are directly related to alcohol intoxication.5

The Centers for Disease Control and Prevention reports that excessive alcohol use is responsible for an annual average of 88,000 deaths and 2.5 million years of potential life lost. More than half of these deaths and three-quarters of the years of potential life lost were due to binge drinking.6

Nationally, Pennsylvania ranks in the top tertile† at 18.5% for age-adjusted prevalence of binge drinking among adults age 18 years or older and in the middle tertile at 7 drinks per occasion for the average largest number of drinks consumed by binge drink-ers on any occasion in the past month.3

Pennsylvania Patient Safety Authority analysts analyzed Serious Events associated with alcohol use, abuse, and intoxication in all care areas and found that failures or inade-quacies of assessing and monitoring were associated with patient harm. Analysts sought to describe the evidence-based best practices for the assessment and management of intoxicated patients.

METHODS

Analysts queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) data-base for event reports related to alcohol intoxication, including reports that described patients under the influence or abuse of alcohol in all acute level facilities, includ-ing hospitals, birthing centers, abortion clinics, and ambulatory surgical facilities in Pennsylvania submitted between January 1, 2005, and December 31, 2015. The follow-ing search terms were used to identify applicable events: alcohol, intoxicated, inebriate, ETOH, drunk, under the influence, unconscious, police, blood alcohol content, BAC, Narcan, sleep off, banana bag, and detox. The initial query resulted in 9,536 reports.

The query was re-run to exclude patients age 0 to 17 years (n = 349) because of the unique needs and different treatment approaches for this population, events occur-ring more than 24 hours after admission (n = 2,888), and events unrelated to alcohol

ABSTRACTWorldwide, harmful use of alcohol causes more than 3 million deaths per year. Two-thirds of American adults consume alcohol and up to 10% abuse it. In the United States every year, more than 600,000 emergency department visits are related to alco-hol intoxication. Pennsylvania ranks in the top third for binge drinking in the United States. Between January 1, 2005, and December 31, 2015, more than 9,500 alcohol-related events were reported to the Pennsylvania Patient Safety Authority through its Pennsylvania Patient Safety Reporting System. Review of narratives revealed 1,327 event reports involving acute alcohol intoxication in adults; 69 were identified as Serious Events, including deaths. Most events occurred in the emergency department. A majority of Serious Events involved patient falls. Other findings, such as seizures, com-bativeness, suicide-related, and leaving against medical advice occurred. Failures or inadequacies of assessing and monitoring intoxicated patients were identified as factors contributing to harm. Assessment and management of these patients—including screening and brief intervention—and behavioral assessment are key elements to the care and prevention of harm of the intoxicated patient. (PA Patient Saf Advis 2017 Jun;14[2]:45-54.)

Corresponding Author Mary C. Magee

R E V I E W S & A N A LY S E S

* Binge drinking is defined as four or more drinks for a woman or five or more drinks for a man on an occasion during the past 30 days.3† Tertile: Any of the two points that divide an ordered distribution into three parts, each containing a third of the population.7

Pennsylvania Patient Safety Advisory Vol. 14, No. 2—June 2017©2017 Pennsylvania Patient Safety Authority

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intoxication (n = 3,975; e.g., events classi-fied as skin integrity or transfusion, events involving staff or visitors, and events reporting only a past medical history of alcohol use). The revised query resulted in 2,324 reports. Analysts individually reviewed the event report narratives and excluded an additional 95 events unre-lated to alcohol intoxication. Of the three main “direct mechanisms of harm caused by alcohol consumption in an individual” presented in the WHO report, the ana-lysts focused on “intoxication, leading to impairment of physical coordination, con-sciousness, cognition, perception, affect or behavior,”1 because this mechanism of harm was the most prevalent in the PA-PSRS database.

Patients presenting for detoxification (n = 544) and those in withdrawal (n = 358; i.e., beyond the intoxication phase) were excluded unless the event nar-rative mentioned both intoxication and detoxification or withdrawal. The final sample size analyzed was 1,327 alcohol intoxication-related events.

Analysts conducted a review of the lit-erature and an Internet search to obtain epidemiological data and information on alcohol use and abuse and to identify assessment and care management strate-gies to reduce the likelihood of patient harm. Interviews with addiction special-ists were conducted to clarify and refine the approach to data analysis.

RESULTS

HarmThe Authority uses the harm level defini-tions as defined by the MCARE Act.8 Most events, 94.8% (n = 1,258)

were classified as Incidents (i.e., events, occurrences, or situations that could have injured the patient but did not) and 5.2% (n = 69) of the reports represented Serious Events (i.e., events causing temporary or permanent harm or death).*

Care AreaAs seen in Figure 1, most intoxicated patients presented to the ED. Of the 926 ED patients, 7.3% (n = 68) were admitted to the hospital and more than a third (34.8%, n = 322) eloped, left before treatment was completed, or left against medical advice. In certain ancil-lary departments (i.e., surgical services, imaging, and outpatient clinics), instances were noted in which testing, treatments, or surgeries were cancelled because of patients arriving under the influence of alcohol or intoxicated.

The following is an example of a cancellation†:

Upon arrival to the pre-op area for a scheduled surgical procedure, nursing staff noticed that the patient had an odor of alcohol. Upon further evaluation by anesthesia, the patient admitted to ingesting alcohol prior to the procedure. Surgeon notified and the surgery was cancelled in the inter-est of patient safety.

Ancillary departments comprised 7.4% (n = 98) of the care areas noted. Of the 98 ancillary department events, 82.6% reports originated from the laboratory. Failure to document or properly report critical alcohol serum lab results led to delays in care. The following is an example of an improperly reported critical value event:

A critical value for serum alcohol was not called and/or documented in the

computer system within the expected time frame.

Serious EventsOf the 5.2% (n = 69 of 1,327) events that were reported as Serious Events, the majority 72.5% (n = 50) as shown in Figure 2, were reported as harm score E (i.e., an event occurred resulting in tem-porary harm and required treatment or intervention).

Of the 69 Serious Events reported, 55.1% (n = 38) described delay or failure to observe, assess, or recognize change in condition as factors contributing to the harmful event. Reports of patient deaths accounted for 7.2% (n = 5 of 69) of the Serious Events and three of the five deaths were attributable to the aforementioned factors. The following are examples of Serious Events mentioning those factors:

Patient admitted to [unit] as a 302 ‡. Nurse returned to room after checking lab results to find patient [had eloped]. Authorities notified.

The patient was being evaluated for possible drug and alcohol overdose. When nurse came back into room, he noticed an empty pill bottle at the bedside. The patient [allegedly] ingested more than 30 benzodiaz-epine tablets.

The patient, who was under the influ-ence of alcohol, was being evaluated for right sided pain. The patient was in CT [unattended] and upon return to the ED the patient’s condition deteriorated, requiring intubation.

Patient admitted to a monitored unit with alcohol intoxication and other medi-cal co-morbidities. The patient went into a lethal cardiac arrhythmia and was * Serious Events are events, occurrences,

or situations involving the clinical care of a patient in a medical facility that either: (a) resulted in death, or (b) compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient.8

† The details of the PA-PSRS event narratives in this article have been modified to preserve confidentiality. None of these event narratives came from the co-author’s facility.

‡ A 302 commitment in Pennsylvania is an involuntary commitment into a mental health institute for emergency psychiatric evaluation.9


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found unresponsive a couple of hours later. The patient later died.

Associated findings. As seen in Figure 3, findings associated with intoxication men-tioned in some events are consistent with characteristics and behaviors of intoxicated patients.10-13 Seizure activity, including delirium tremens, was the most frequently mentioned finding. All of the patients experiencing seizure sustained a fall, with harm ranging from abrasion to fracture; eight occurred in non-psychiatric EDs and two on intermediate/specialty units.

Suicide, including suicide attempts and suicidal ideation, was the second most frequently mentioned finding. Of the two completed suicides, one followed an inpatient admission and subsequent ED visit; the other occurred in the facility.

Both patients had comorbid behavioral health diagnoses. The other patients sus-tained harm ranging from self-inflicted wounds to cardiac and respiratory arrest; Most suicide-related events occurred in non-psychiatric EDs. The following is an example of a suicide-related event:

The patient was brought to the ED with alcohol intoxication after a sui-cide attempt. Patient had been acting cooperatively until staff found patient with [equipment] cables [wrapped] around neck. Staff intervened and patient was placed on one-to-one observation.

Combativeness was the third most frequently mentioned finding. Half of the combative patients attempted to physically harm staff and half sustained

a dislocation or actual or probable frac-ture, two of which occurred as a result of physical restraint and the others sustained harm including lacerations; seven injuries occurred in the ED and one on an inpa-tient rehabilitation unit.

Patients who took sedative-hypnotics, opioids, or other drugs; ingested hand sanitizer or mouthwash; plus those who eloped account for 14.5% (n = 10) of the other findings mentioned. The majority of these 10 were ED patients.

Event type. As seen in Figure 4, the major-ity, 61% (n = 42 of 69), of Serious Events were falls; 64.3% (n = 27) of the 42 falls were unobserved. Of the 35.7% (n = 15) that were observed, staff attempted, unsuccessfully, to prevent the fall. Patients experiencing seizure activity accounted for

0

200

400

600

800

1,000

MS17

123

NUMBER

CARE AREA

926

98 92 88 56 48 15 4

Outpatientclinic

ImagingPsychiatric/rehabilitation

unit

Surgicalservices/labor anddelivery

Criticalcare/

intermediateunit

General andspecialty

unit

Ancillarydepartment

Emergencydepartment

Figure 1. Intoxication Events by Care Area (N = 1,327)

Note: Data reported through the Pennsylvania Patient Safety Reporting System, January 2005 through December 2015.


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23.8% (n = 10) of the 42 falls. Of the 27 unobserved falls, 7 patients experienced seizure activity, and of the 15 observed falls, 3 patients experienced seizure activity.

The following are examples of reported falls with harm events:

Patient was intoxicated, climbed over the side rails, fell to the floor, and landed on the left hip. X-ray con-firmed a fracture and patient went to surgery.

While standing for additional x-rays, the patient fell forward, landing on [her] face. The fall resulted in a laceration and a probable [cervical] fracture.

Patient was intoxicated upon arrival to ED and sustained a scalp laceration. CT showed an epidural hematoma. While waiting to be transferred to [an inpatient unit], the patient fell out of bed. A repeat CT showed an [increasing hematoma]. The patient was then admitted to a [critical care unit].

Reports of other/miscellaneous events accounted for 27.5% (n = 19 of 69) of the Serious Events. The following are examples of reported other/miscellaneous events that show a range of care chal-lenges with this patient population:

Patient was [intoxicated and violent] upon arrival to ED. The patient was placed in restraints and later found to have deep lacerations to torso. Broken glass was used by the patient to [self-inflict these injuries]. The patient was taken to the OR for exploratory surgery and there was no permanent injury sustained.

An [intoxicated] patient became [extremely violent]. Staff was unable to [verbally] de-escalate the situation and the patient began kicking and

0

2

4

6

8

10

12

MS17

125

NUMBEROF EVENTS

FINDING

Elope

ment/le

ft aga

inst

medica

l adv

ice

Ingest

ion of

hand

sanit

izer/m

outhw

ash

Contro

lled s

ubsta

nce

Comba

tiven

ess

Suici

de-re

lated

Seizu

re

109

8

5

32

Figure 3. Serious Events with Associated Findings (N = 69)

Note: Data Reported through the Pennsylvania Patient Safety Reporting System, January 2005 through December 2015; data is not mutually exclusive.

MS17

124

0

10

20

30

40

50

60NUMBER

HARM SCORE

E F G H I

50

13

0 15


Figure 2. Intoxication Events Reported as Serious Events By Harm Score (N = 69)


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punching staff and police officer used a Taser [to gain control of the patient].

A patient with a history of a psy-chiatric disorder was brought to the ED intoxicated. Patient was kept overnight for observation. During morning assessment patient denied that [her binge drinking] was a sui-cide attempt. Patient contracted for safety and was [agreeable to inpatient treatment]. [Several hours later,] the patient began yelling and started to vomit. [She] lost consciousness, [stopped breathing], and required intubation. A repeat ETOH [ethyl alcohol] level was elevated. Staff noticed an empty bag of hand sani-tizer in the trash. The patient was admitted to a [telemetry] bed.

DISCUSSION

Acute Symptom Assessment “A person is said to suffer from alcohol intoxication when the quantity of alcohol the person consumes produces behavioral or physical abnormalities.

In other words, the person’s mental and physical abilities are impaired.”1

In addition to observable impaired physi-cal and mental abilities, alcohol levels can be measured in the breath or blood. Studies have found, however, that the level of blood alcohol concentration (BAC) correlates poorly with physical and mental impairments depending on the alcohol tolerance of the individual.10,14,15 An overreliance on these concentrations may hinder healthcare providers’ abil-ity to protect these patients from harm. Assessment of signs and symptoms in

a person who has been drinking have proved effective in accurately determining alcohol intoxication, and the BAC can verify a patient’s report of intoxication.16

Teplin and Lutz’s Alcohol Symptom Checklist (ASC) is an observational measure of intoxication and is used in situations in which objective measures of alcohol are unavailable.17 The ASC is a reliable, easy, and efficient tool that can be used in lieu of a BAC when, for example, an intoxicated patient refuses diagnostic testing.17

In a 2013 study by Volz et al., the authors measured the effectiveness of a behavior-ally-based alcohol intoxication scale for assessing a patient’s readiness for transfer from the ED to the behavioral health unit “rather than relying solely on a BAC level.”14 Patients who met specific criteria in this behavioral scale were found to be medically stable after transfer.14

Failure to observe, assess, or recognize changes in patient condition were associ-ated with harmful events and deaths as identified and reported through PA-PSRS. Alcohol intoxication causes changes to several organ systems, including cardio-vascular, neurological, endocrine, and pulmonary; and the degree of impact depends on the amount of alcohol consumed and the patient’s tolerance level.2,18,19 Care of the patient is aimed at managing the intoxication symptomology, comorbidities, and acute injuries.

Treatment interventions include physi-ologic monitoring, frequent observation and rounding, supportive care, and prevention of harm or injury.18 Frequent rounding and direct observation, including waking sleeping patients to assess responsiveness, is associated with decreases in secondary harm.18,20

Reoccurrence Prevention – Screening and Brief InterventionImplementing screening for alcohol-dependent drinkers and providing brief

MS17

126

EVENT TYPE

PERCENTAGE

Patient self-harm

Medication error

Error related toprocedure/test/treatment

Complication related toprocedure/test/treatment

Other/miscellaneous

Fall

1.4

1.4

2.9

5.8

27.5

61.0

0 10 20 30 40 50 60 70 80

Figure 4. Intoxication-Related Serious Events by Event Type (N = 69)

Note: Reported through the Pennsylvania Patient Safety Reporting System, January 2005 through December 2015.


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intervention for those who screen posi-tive or at-risk for alcohol dependency is shown to reduce the quantity of alcohol consumed and re-visits to the ED.16,21-24 Varying levels of screening, brief interven-tion, and follow up may be incorporated into interactions with the intoxicated patient. Initial screening serves as the basis for determining appropriate intervention.

Screening and brief intervention is supported by the American College of Emergency Physicians (ACEP), the Emergency Nurses Association, and the American College of Surgeons’ Committee on Trauma, which “recom-mends that all trauma centers incorporate alcohol screening and brief intervention as part of routine trauma care” and those with “sufficient resources” discuss or offer follow-up options.16,25,26

Several screening tools are advocated, including a single alcohol screening ques-tion (SASQ), the Alcohol Use Disorders Identification Test (AUDIT), the Cutting down, Annoyance by criticism, Guilty feeling, and Eye openers (CAGE) ques-tionnaire, the CRAFFT Substance Abuse Screening Test, and the Paddington Alcohol Test.21,27-32 These evidence-based screening tools are tailored for time-pressed environments such as the ED and take into account the possibility of patient underreporting of alcohol intake.

Brief interventions are short counseling sessions. The goal of brief intervention is to help patients make decisions to lower their risk for alcohol-related incidents. Giving information and feedback about screening results helps point out the danger and educate patients on accept-able limits of alcohol intake. The Table identifies alcohol use screening tools and brief intervention resources found in the literature, the predictive trait of the tool, and which population they have been used to evaluate.

Understanding the patient’s perception of drinking helps enhance motivation to promote change in drinking habits.16,33 Giving advice and negotiating helps the patient take steps and commit to change.16 Following up reinforces the intervention and can include various forms of contact such as phone calls, appointments with primary care physicians, and referral to Alcoholics Anonymous.21,33 ED DIRECT is a mnemonic that helps providers remember components of this brief intervention.25 Supported by ACEP, ED DIRECT is administered in the ED to “at-risk” or “harmful” drinkers with a goal of speaking with a counselor while in the ED or referral to primary care or special-ized treatment program.25

Healthcare providers’ attitudes, biases, and perceptions of alcohol-intoxicated patients are associated with inadequate assessment and the lack of frequent monitoring and use of behavioral assessment scales.34-36 Ongoing staff education on the rationale and use of objective assessment scales and screening tools; in conjunction with edu-cation regarding their own attitudes and perceptions, are keys to successful imple-mentation of these useful strategies.34-36

Facility Recommendations to Improve Patient Safety A number of recommendations were submitted in event reports specific to reported challenges.

These recommendation examples are typi-cal of those proposed by facility staff for patients who fell:

Use fall precautions including a bed alarm and place patient on continu-ous observation.

Notify family. Perform neurologic assessments frequently, closer monitor-ing of patients who are at increased fall risk, and place the patient in a room closer to the nurse’s station.

Provide reminders to patient and family, maintain communication. Intoxicated patients should be assessed as high fall risk and those with gait disturbances shall have staff in attendance.

Patients who leave against medical advice (AMA) pose unique considerations for staff. As shown in these examples, facility staff feel obligated or are required to dis-charge these patients under supervision:

The patient was [insistent on leaving AMA]. [The patient was taken] into police custody to ensure [she] would not be a danger to [herself] or others.

The local police provided the [inebri-ated] patient transportation home.

The patient [was discharged] AMA accompanied by a friend.

Facility staff also note the need for fre-quent communication, closer observation, and follow-up phone calls as indicated in these examples:

When there is a delay, commu-nicating with the patient and family frequently may help decrease frustration.

Frequently monitor patients who have mentioned the desire to leave.

A follow up phone call was made to ensure the patient arrived at the treatment facility.

The ingestion of hand sanitizer is on the rise nationally,37 although not prevalent in the reported events submitted through PA-PSRS, where 1.6% of all events (n = 21 of 1,327) and 4.3% of Serious Events (n = 3 of 69) involved the ingestion of hand sanitizer or other ethanol-containing products. Intoxicated patients and those with alcohol use disorders are more likely to consume this product while in the hospital because of its availability. Although most instances

(continued on page 52)


Page 51

Table: Alcohol Use Screening and Brief Intervention Resources

RESOURCE DESCRIPTION POPULATION ADDRESSED

Single Alcohol Screening Question (SASQ)1

A single screening question for identifying hazardous drinking and alcohol use disorders.

The study focused on adult patients presenting to emergency departments within 48 hours of an injury.

Alcohol Use Disorders Identification Test (AUDIT)2,3

A screening instrument for proactive identification of hazardous and harmful alcohol consumption. The instrument is a 10-item questionnaire that covers the domains of alcohol consumption, drinking behavior, and alcohol-related problems.

The 1993 study focused on subjects recruited from representative primary health care facilities in six countries (age not specified).

The 2005 study focused on patients 18 years or older presenting to one of three hospital emergency departments within 48 hours of an injury.

Cutting down, Annoyance by criticism, Guilty feeling, and Eye-openers questionnaire (CAGE)3,4

A screening instrument for identifying a high likelihood of the presence of alcoholism.

The 1984 study focused on male patients in an alcoholism rehabilitation facility.

The 2005 study focused on patients 18 years or older presenting to one of three hospital emergency departments within 48 hours of an injury.

Car, Relax, Alone, Forget, Friends, Trouble questionnaire (CRAFFT)5

A screening instrument for identifying substance-related problems and disorders.

The study focused on adolescents, age 14 to 18 years, coming for routine medical care to an adolescent and young adult medical practice.

Paddington Alcohol Test (PAT) and brief intervention6,7

A screening instrument for identifying alcohol-related problems.

A referral to an alcohol health worker made while the patient is still in the emergency department.

The May 2004 study focused on adult patients presenting to the emergency department.

The October 2004 study focused on adult patients 18 years or older presenting to an emergency department and having a positive PAT screen.

Screening and brief intervention (BI) in the emergency department8

A review of four studies that offered brief interventions to patients, while still in the emergency department, whose injuries were alcohol-related. The effect of the BI was generally positive (i.e., patients decreased their alcohol consumption and alcohol-related negative consequences after the BI when assessed 3 to 12 months after their initial emergency department visit).

The studies focused on adolescent and adult patients 13 years or older admitted to an emergency department or trauma center.

Notes1. Williams R, Vinson DC. Validation of a single screening question for problem drinking. J Fam Pract. 2001 Apr;50(4):307-12. PMID: 11300981.2. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the alcohol use disorders identification test (AUDIT): WHO collaborative

project on early detection of persons with harmful alcohol consumption--II. Addiction. 1993 Jun;88(6):791-804. PMID: 8329970.3. Canagasaby A, Vinson DC. Screening for hazardous or harmful drinking using one or two quantity-frequency questions. Alcohol Alcohol. 2005 May-

Jun;40(3):208-13. Also available: http://dx.doi.org/10.1093/alcalc/agh156. PMID: 15797883.4. Ewing JA. Detecting alcoholism. The CAGE questionnaire. JAMA. 1984 Oct 12;252(14):1905-7. PMID: 6471323.5. Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr

Adolesc Med. 2002 Jun;156(6):607-14. PMID: 12038895.6. Patton R, Hilton C, Crawford MJ, Touquet R. The Paddington Alcohol Test: a short report. Alcohol Alcohol. 2004 May-Jun;39(3):266-8. PMID: 15082467.7. Crawford MJ, Patton R, Touquet R, Drummond C, Byford S, Barrett B, Reece B, Brown A, Henry JA. Screening and referral for brief intervention of alcohol-

misusing patients in an emergency department: a pragmatic randomised controlled trial. Lancet. 2004 Oct 9-15;364(9442):1334-9. PMID: 15474136.8. D’Onofrio G, Degutis LC. Screening and brief intervention in the emergency department. Alcohol Res Health. 2004-2005;28(2):63-72. PMID: 19006993.


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of intentional hand sanitizer inges-tion result in little or no harm to the patient, a literature review of published cases and a query of the National Poison Data System iden-tified cases of moderate to severe harm.38 The study suggests increasing awareness by healthcare providers of this growing problem and taking steps such as removing hand sanitizers from at-risk patients’ rooms and frequent patient monitoring.38

Although it was beyond the scope of this article to address the management of alco-hol withdrawal, the possibility cannot be ignored that an alcohol-dependent patient may remain in the ED or hospital long enough to be at high risk for develop-ing withdrawal even if presenting for an unrelated complaint.39 Researchers recom-mend that healthcare providers

be familiar with the care and management of alcohol withdrawal, including symptom recognition, medication regimens, and supportive care such as frequent monitor-ing, limiting sensory stimulation, and providing reassurance.19,39,40

LIMITATIONS

Relevant information is derived from the event type taxonomy and from free-text narratives; categorization and narra-tive detail were provided by PA-PSRS reporters.

Reporters may have used the terms “intoxication,” “detoxification,” and “withdrawal” interchangeably and in com-bination when providing the narrative detail. Analysts sorted the events based on the use of these terms as described in the methods section and every effort was made to classify events into these catego-ries accurately.

CONCLUSION

Caring for and safeguarding intoxi-cated patients poses unique challenges, including managing patient aggression, monitoring patients for deterioration, and gaining cooperation with treatments.

About 5% of the intoxication-related events reported to the Authority were Serious Events (i.e., events in which patients sustained harm). Pennsylvania acute level facilities reported that among intoxicated patients, the occurrence of falls, seizures, suicide attempts, combative-ness, and patients leaving against medical advice were common. Failure to adequately monitor and assess intoxicated patients contributed to the majority of harm experienced by these patients and in rare instances resulted in death. Behavioral assessments and frequent or continuous monitoring, supplemented by objective measurements such as blood alcohol con-centration in combination with symptom management, are key to avoiding harm and caring for these patients.

NOTES

1. Global status report on alcohol and health 2014. Geneva: World Health Organiza-tion (WHO); 2014. 86 p. Also available: http://www.who.int/substance_abuse/publications/global_alcohol_report/msb_gsr_2014_1.pdf?ua=1.

2. Cowan E, Su M. Ethanol intoxication in adults. In: UpToDate [internet]. Waltham (MA): UpToDate; 2014 [accessed 2014 May 07]. [8 p]. Available: http://www.uptodate.com.

3. Data and maps: Excessive drinking. [inter-net]. Atlanta (GA): Centers for Disease Control and Prevention (CDC); 2016 Sep 6 [accessed 2016 Oct 25]. Available: http://www.cdc.gov/alcohol/data-stats.htm.

4. National Survey on Drug Use and Health, 2013 and 2014. Rockville (MD): Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Behavioral Health Statistics and Quality; 2015 Sep 10. Table 2.46B - Alcohol use, binge alcohol use, and heavy alcohol use in the past month among

persons aged 18 or older, by demographic characteristics: percentages, 2013 and 2014. Also available: http://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs2014/NSDUH-DetTabs2014.htm#tab2-46b.

5. Pletcher MJ, Maselli J, Gonzales R. Uncomplicated alcohol intoxication in the emergency department: an analysis of the National Hospital Ambulatory Medical Care Survey. Am. J. Med. 2004 Dec 1;117(11):863-7. Also avail-able: http://dx.doi.org/10.1016/j.amjmed.2004.07.042. PMID: 15589492

6. Centers for Disease Control and Preven-tion (CDC). Alcohol-related disease impact (ARDI). [internet application]. Atlanta (GA): Centers for Disease Control and Prevention (CDC); [accessed 2016 Nov 09]. Available: https://nccd.cdc.gov/DPH_ARDI/default/default.aspx.

7. Tertile. [internet]. Burlingame (CA): Your Dictionary; [accessed 2016 Nov 09]. [1 p].

Available: http://www.yourdictionary.com/tertile.

8. Medical Care Availability and Reduc-tion of Error (MCARE) Act of March 20, 2002, P.L. 154, No. 13, Cl. 40.;Available: http://www.legis.state.pa.us/cfdocs/legis/li/uconsCheck.cfm?yr=2002&sessInd=0&act=13.

9. Q: What is a 302 commitment in Pennsylvania? [internet]. Reference.com; [accessed 2016 Dec 28]. [1 p]. Available: https://www.reference.com/government-politics/302-commitment-pennsylvania-a2780351abbc9039.

10. Olson KN, Smith SW, Kloss JS, Ho JD, Apple FS. Relationship between blood alcohol concentration and observable symptoms of intoxication in patients presenting to an emergency department. Alcohol Alcohol. 2013 Jul-Aug;48(4):386-9. Also available: http://dx.doi.org/10.1093/alcalc/agt042. PMID: 23690233

(continued from page 50)

http://www.yourdictionary.com/tertile

http://www.yourdictionary.com/tertile


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11. Ambrosius RG, Vroegop MP, Jansman FG, Hoedemaekers CW, Aarnoutse RE, van der Wilt GJ, Kramers C. Acute intoxication patients presenting to an emergency department in The Nether-lands: admit or not? Prospective testing of two algorithms. Emerg Med J. 2012 Jun;29(6):467-72. Also available: http://dx.doi.org/10.1136/emj.2010.106500. PMID: 21546510

12. Alcohol intoxication. [internet]. eMedi-cine.com; 2016 [accessed 2016 Nov 09]. [6 p]. Available: http://www.emedicine health.com/alcohol_intoxication/article_em.htm#alcohol_intoxication_facts.

13. Berger JT. Discharge against medical advice: ethical considerations and profes-sional obligations. J Hosp Med. 2008 Sep;3(5):403-8. Also available: http://dx.doi.org/10.1002/jhm.362. PMID: 18951403

14. Volz TM, Boyer KS. The development of a behaviorally-based alcohol intoxication scale. J Emerg Nurs. 2014 Jul;40(4):330-5. Also available: http://dx.doi.org/10.1016/j.jen.2013.09.008. PMID: 24182893

15. Roberts JR, Dollard D. Alcohol levels do not accurately predict physical or mental impairment in ethanol-tolerant subjects: relevance to emergency medicine and dram shop laws. J Med Toxicol. 2010 Dec;6(4):438-42. Also available: http://dx.doi.org/10.1007/s13181-010-0048-z. PMID: 20358415

16. American College of Surgeons Com-mittee on Trauma. Alcohol screening and brief intervention (SBI) for trauma patients. Chicago (IL): American College of Surgeons; 16 p. Also available: https://www.facs.org/~/media/files/quality%20programs/trauma/publications/sbirt-guide.ashx.

17. Teplin LA, Lutz GW. Measuring alcohol intoxication: the development, reli-ability and validity of an observational instrument. J Stud Alcohol. 1985 Nov;46(6):459-66. PMID: 4087907

18. Johnson JM. Last call: ethanol metabo-lism and the implications for emergency department clinicians managing patients with extreme ethanol intoxication. Adv Emerg Nurs J. 2009 Jul-Sep;31(3):221-7. Also available: http://dx.doi.org/10.1097/TME.0b013e3181afbf3a. PMID: 20118874

19. Sutton LJ, Jutel A. Alcohol withdrawal syndrome in critically ill patients: identifi-cation, assessment, and management. Crit Care Nurse. 2016 Feb;36(1):28-38. Also available: http://dx.doi.org/10.4037/ccn2016420. PMID: 26830178

20. Gardner B. Intoxication guideline. Der-byshire Healthcare NHS Foundation Trust; 2012 Feb. 12 p. Also available: www.derbyshirehealthcareft.nhs.uk/Easy-SiteWeb/GatewayLink.aspx?alId=4291.

21. Crawford MJ, Patton R, Touquet R, Drummond C, Byford S, Barrett B, Reece B, Brown A, Henry JA. Screen-ing and referral for brief intervention of alcohol-misusing patients in an emergency department: a pragmatic randomised controlled trial. Lancet. 2004 Oct 9-15;364(9442):1334-9. PMID: 15474136

22. Bernstein E, Bernstein JA. Chapter 12. Implementing brief interventions: a series of five papers. In: Cherpitel CJ, Borges G, Giesbrecht N, Hungerford D, Peden M, Poznyak V, Room R, Stockwell T, editors. Alcohol and injuries: emergency department studies in an international perspective. Geneva: World Health Orga-nization (WHO); 2009. p. 175-80. Also available: http://www.bu.edu/bniart/files/2011/02/SBIRT-implementing-intervention.pdf.

23. Verelst S, Moonen PJ, Desruelles D, Gil-let JB. Emergency department visits due to alcohol intoxication: characteristics of patients and impact on the emergency room. Alcohol Alcohol. 2012 Jul-Aug;47(4):433-8. Also available: http://dx.doi.org/10.1093/alcalc/ags035. PMID: 22493048

24. Johnson JA, Woychek A, Vaughan D, Seale JP. Screening for at-risk alcohol use and drug use in an emergency depart-ment: integration of screening questions into electronic triage forms achieves high screening rates. Ann Emerg Med. 2013 Sep;62(3):262-6. Also available: http://dx.doi.org/10.1016/j.annemerg-med.2013.04.011. PMID: 23688769

25. Alcohol screening and brief intervention in the emergency department. Irving (TX): American College of Emergency Physi-cians; 3 p. Also available: https://www.acep.org/Clinical---Practice-Management/Alcohol-Screening-and-Brief-Intervention-in-the-ED/.

26. Substance abuse (alcohol/drug) and the emergency care setting. Emergency Nurses Association; 2010. Also available: http://www.apna.org/files/public/substance_abuse_and_the_emergency_care_ setting.pdf.

27. Williams R, Vinson DC. Validation of a single screening question for problem drinking. J Fam Pract. 2001 Apr;50(4):307-12. PMID: 11300981

28. Canagasaby A, Vinson DC. Screen-ing for hazardous or harmful drinking using one or two quantity-frequency questions. Alcohol Alcohol.. 2005 May-Jun;40(3):208-13. Also available: http://dx.doi.org/10.1093/alcalc/agh156. PMID: 15797883

29. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harm-ful alcohol consumption--II. Addiction. 1993 Jun;88(6):791-804. PMID: 8329970

30. Ewing JA. Detecting alcoholism. The CAGE questionnaire. JAMA. 1984 Oct 12;252(14):1905-7. PMID: 6471323

31. Knight JR, Sherritt L, Shrier LA, Harris SK, Chang G. Validity of the CRAFFT substance abuse screening test among adolescent clinic patients. Arch Pediatr Adolesc Med. 2002 Jun;156(6):607-14. PMID: 12038895

32. Patton R, Hilton C, Crawford MJ, Tou-quet R. The Paddington Alcohol Test: a short report. Alcohol Alcohol. 2004 May-Jun;39(3):266-8. PMID: 15082467

33. D’Onofrio G, Degutis LC. Screening and brief intervention in the emergency department. Alcohol Res Health. 2004-2005;28(2):63-72. PMID: 19006993

34. Brosinski C, Riddell A. Mitigating Nurs-ing Biases in Management of Intoxicated and Suicidal Patients. J Emerg Nurs. 2015 Jul;41(4):296-9. Also available: http://dx.doi.org/10.1016/j.jen.2014.11.002. PMID: 25583427

35. Kabale BM, Nkombua L, Matthews P, Offiong BE. Healthcare professionals’ perceptions of alcohol-intoxicated trauma patients: implecations for healthcare delivery at South Rand Hospital emer-gency department. S Afr Fam Pract. 2013;55(4):398-402.


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36. Warren OU, Sena V, Choo E, Machan J. Emergency physicians’ and nurses’ attitudes towards alcohol-intoxicated patients. J Emerg Med. 2012 Dec;43(6):1167-74. Also avail-able: http://dx.doi.org/10.1016/j.jemermed.2012.02.018. PMID: 22525698

37. Hand sanitizer. [internet]. Alexandria (VA): American Association of Poison Control Centers (AAPCC); [accessed 2017 Apr 03]. [4 p]. Available: http://www.aapcc.org/alerts/hand-sanitizer/.

38. Gormley NJ, Bronstein AC, Rasimas JJ, Pao M, Wratney AT, Sun J, Aus-tin HA, Suffredini AF. The rising incidence of intentional ingestion of ethanol-containing hand sanitizers. Crit Care Med. 2012 Jan;40(1):290-4. Also available: http://dx.doi.org/10.1097/CCM.0b013e31822f09c0. PMID: 21926580

39. Stehman CR, Mycyk MB. A rational approach to the treatment of alcohol withdrawal in the ED. Am J Emerg Med. 2013 Apr;31(4):734-42. Also available: http://dx.doi.org/10.1016/j.ajem.2012.12.029. PMID: 23399338

40. Zerhouni O, Bègue L, Brousse G, Carpen-tier F, Dematteis M, Pennel L, Swendsen J, Cherpitel C. Alcohol and violence in the emergency room: a review and per-spectives from psychological and social sciences. Int J Environ Res Public Health. 2013 Sep 27;10(10):4584-606. Also available: http://dx.doi.org/10.3390/ijerph10104584. PMID: 24084671


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INTRODUCTION

The overall dispensing accuracy rate in community pharmacies is estimated to be 98.3% (77 errors among 4,481 prescriptions).1 Despite this level of accuracy, about 4 errors occur per day in a pharmacy filling 250 prescriptions daily. Extrapolating these numbers means that an estimated 64 million errors occur during the dispensing of 4 billion prescriptions annually in America’s pharmacies.2

Outpatient pharmacies operate in a variety of settings, including entities affiliated with or located within hospitals, health systems, and clinics as well as freestanding pharmacies. The pharmacists who staff these pharmacies provide a variety of services to the community, including dispensing prescriptions, administering immunizations, providing medication-therapy management, providing patient education, and making recommendations for over-the-counter medications.

When dispensing medications, pharmacists perform tasks that can be repetitive, yet require high levels of professional training and optimal performance under consider-able time constraints.3 Dispensing a prescription can involve more than 40 separate steps.4 Combine this with the numerous distractions from telephones, e-mails, cus-tomers, and the supervision of technicians, and a system emerges that is perfectly positioned to facilitate errors at any step in pharmacy dispensing process.

The outpatient pharmacy setting provides a unique problem, that errors might go unnoticed for months and may result in negative outcomes. Patients usually receive a 30-day supply of medication and possibly up to a 90-day supply with a prescription. If an error occurs, the patient may end up using the wrong therapy or wrong dose for a significant period of time.

Pennsylvania Patient Safety Authority analysts examined medication errors coded to have occurred in an outpatient pharmacy setting to determine the types of events, the steps in the pharmacy dispensing process in which the event occurred (when that infor-mation was available), and contributing factors.

METHODS

Analysts queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) database for errors from January 2005 through December 2016, looking for events that were categorized as occurring in a hospital’s outpatient pharmacy setting. To identify poten-tial event reports, analysts queried the care-area field for: Pharm*, Phar*, or Rx* and the care-area name field for: out*, comm*, reta*, or amb*. This query yielded 1,044 event reports. The medications involved in the reports were standardized to either their brand or generic name. A medication was considered to have reached the patient if the medication left the control of the pharmacy or pharmacy staff and was dispensed or delivered to the patient. Reporters assigned harm scores, which are adapted from the National Coordinating Council for Medication Error Reporting and Prevention harm index,5 and categorized events based on the type of error.

ANALYSIS

Event reports were categorized by their event type. The top five event types (Figure 1) comprised 69.9% of the reports. The top three event types were wrong drug, medica-tion list incorrect, and wrong dose/over dosage. The ages of the patients involved in the events were as follows: 9.8% (n = 102) involved pediatric patients (younger than 18 years of age), 73.6% (n = 769) involved adult patients (age 18 to 64), and 16.6% (n = 173) involved elderly patients (age 65 or older). More than half (56.2%; n = 587)

Errors Originating in Hospital and Health-System Outpatient Pharmacies

ABSTRACTAlthough a majority of prescriptions dispensed daily in outpatient pharma-cies will be correct, errors can occur. Prescriptions dispensed in an outpatient setting are usually for a 30- and occa-sionally a 90-day supply, which means that an error may not be intercepted for a month or longer, potentially causing patient harm. Analysts reviewed medica-tion errors reported to the Pennsylvania Patient Safety Authority that occurred in outpatient pharmacy settings. Of the 1,044 errors, the top three event types were wrong drug (19.6%, n = 205), medication list incorrect (17.0%, n = 178), and wrong dose/over dos-age (14.7%, n = 153). More than half (56.2%; n = 587) of the events reached the patient. Error-reduction strategies can be implemented in multiple stages of the prescription fill-ing process, including during triage and order entry, production, and point of sale. Counseling patients about their medication at the point of sale can intercept errors and help patients take their medications appropriately and safely. (Pa Patient Saf Advis 2017 Jun;14[2]:55-63.)

Corresponding AuthorMatthew Grissinger

Maximilian Straka, PharmD Patient Safety Analyst

Michael J. Gaunt, PharmD Sr. Medication Safety Analyst

Matthew Grissinger, RPh, FISMP, FASCP Manager, Medication Safety Analysis Pennsylvania Patient Safety Authority



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of the events reached the patient (Harm Score C – I; Figure 2). Analysts also iden-tified that 5.9% (n = 62) of the events submitted to the Authority involved deliv-ery of a prescription to the patient’s home or other location.

Wrong DrugWrong drug errors comprised 19.6% (n = 205) of all the errors, and 89.3% (n = 183) of these errors reached the patient. It should be noted that nearly half (48.3%, n = 99) of the reports did not provide the names of both medica-tions involved (e.g., the report only listed one drug when two drugs were involved) in the medication name fields. There were 105 different drugs mentioned in reports and 147 unique combination of drugs involved in wrong drug errors. The most common drug mentioned in reports of wrong drug errors was the opioid analgesic traMADol (10.7%, n = 22), of which the majority (68.2%, n = 15) were drug mix-ups with traZODone, an antidepressant. The next most common drug involved in wrong drug errors was metoprolol (5.4%, n = 11), with 72.7% (n = 8) of the mix-ups occurring between immediate release metoprolol tartrate and long-acting meto-prolol succinate.

The other wrong drug mix-ups worth noting were within drug classes rather than individual medications. Mix-ups between different oral contraceptive products comprised 7.8% (n = 16) of the errors. Mix-ups between different insulin products comprised 7.3% (n = 15). The remaining 68.8% (n = 141) of the errors involved at least 121 different medica-tions. Following are examples of wrong drug errors reported through PA-PSRS:*

Patient received traZODone instead of traMADol. After taking the dose, she fell on floor. She felt woozy and sleepy. Received multiple traZODone

* The details of the PA-PSRS event narratives in this article have been modified to preserve confidentiality.

EVENT TYPE

Wrong drug

NUMBER OF REPORTS

Medicationlist incorrect

Wrong dose/over dosage

Wrong dose/under dosage

Wrongpatient

MS17413

205(19.6%)

0

50

100

150

200

250

178(17.0%)

153(14.7%)

106(10.2%) 88

(8.4%)

Figure 1. Top Five Outpatient Pharmacy-Related Medication Error Event Types (N = 1,044)


NUMBEROF REPORTS

HARM SCORE

0

100

200

300

400

500

600

A B1 B2 C D E IF G H

32(3.1%)

33(3.2%)

392(37.5%)

480(46.0%)

106(10.2%)

0(0.0%)

1(0.1%)

0(0.0%)

0(0.0%)

0(0.0%)

MS17

415

Incident Serious Event

Reports of events that did not reach the patient (N = 457, 43.8%)

Reports of events that reached the patient (N = 587, 56.2%)

Figure 2. Harm Scores for Outpatient Pharmacy–Related Medication-Error Events (N = 1,044)

Notes: Data reported through the Pennsylvania Patient Safety Reporting System, January 2005 through December 2016. Percentages add up to more than 100% because of rounding.


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tablets. Called pharmacy to report error. Noticed tablets were different.

Patient received traZODone instead of traMADol in his dispensed medi-cation prescription. He actually took his wife’s medication that was also filled incorrectly.

Patient was prescribed triamcinolone and label was typed for triam-cinolone. Nystatin was dispensed. Nystatin did not help the patient’s poison ivy and additional predni-SONE was dispensed.

Patient received Singulair® [montelu-kast] 10 mg and Zyrtec® [cetirizine] 10 mg. Each bottle was labeled with opposite drug and directions. Patient had remaining Zyrtec from previous fill in her old bottle. Therefore, for a few days, she had been taking two Zyrtec tablets and no Singulair. She reported feeling a little drowsier than usual.

Two tablets of pravastatin 20 mg were found in a bottle of Paxil® [PARoxetine] 20 mg filled by the outpatient pharmacy. Pravastatin was in the robot and was exchanged out for Paxil. The pharmacist believes two tablets of the pravastatin must have remained behind when exchanging out for Paxil. The patient brought the incorrect tablets back [to the pharmacy] and the error will be addressed with next training to be sure robot is empty of all drugs when exchanging out.

Medication List IncorrectThe second most common event type selected by facilities was medication list incorrect (17.0%, n = 178). Within this category, analysts identified 15 different types of errors. The top error types were incorrect instructions (23.0%, n = 41), medication not discontinued (13.5%, n = 24), and wrong strength (13.5%, n = 24). See Figure 3. At least 80 different medications were involved in errors. Only SEROquel® (QUEtiapine; 12.4%,

n = 22), an antipsychotic agent, was involved in more than 10% of the medica-tion list incorrect events. Nearly 28% (n = 49) of the events involved antipsy-chotics, while 12.4% (n = 22) involved antidepressants. Following are some reported errors in which the medication list was incorrect:

Doctor wrote order for fentaNYL [transdermal system] 12 mcg/hr, change every 3 days, start today. Pharmacy had order in twice for today.

Oxazepam 10 mg ordered. Entered as ZyPREXA® (OLANZapine) 10 mg by mouth every 8 hours when neces-sary. The patient did not receive any Zyprexa.

Wrong Dose/Over DosageThe third most common event type was wrong dose/over dosage (14.7%, n = 153). In 36.6% (n = 56) of the events there was a two-fold overdose, while 3.9% (n = 6) involved a 10-fold overdose. Nearly 35% (n = 53) of the event reports did not have enough information to determine the

amount of drug the patient received. In 11.8% (n = 18) of the events, the actual product dose strength was correct, but the instructions would have had the patient take a higher dosage. Of these overdoses, 85.0% (n = 130) reached the patient. In 14.4% (n = 22) of these events, the patient took at least one dose of the medication. Discovery of some of these errors did not occur until the time of the patient’s first refill (11.8%, n = 18) or even months after the initial dispensing of the prescription (7.8%, n = 12). There were 98 different drugs mentioned in wrong dose/over dos-age reports, including vitamin D (5.2%, n = 8), metFORMIN (4.6%, n = 7), hydro-CHLOROthiazide (3.3%, n = 5), and lansoprazole (2.6%, n = 4).

The following are examples of reported wrong dose/over dosage events:

Directions on the label were to inject 0.4 mL (5,000 units) [epoetin alfa] via IV every 7 days. Actually, the cor-rect volume to inject for 5,000 units is 0.25 mL. Labs drawn to assess harm. No harm to patient.

MS17

416

ERROR TYPE

NUMBER OF REPORTS

Incorrect instructions

Medication notdiscontinued

Wrong strength

Missed order

Duplicate order

41(23.0%)

24(13.5%)

24(13.5%)

20(11.2%)

18(10.1%)

0 5 10 15 20 25 30 35 40 45

Figure 3. Top Five Types of Medication List Incorrect Errors (N = 178)



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A 60-year-old female was prescribed PROzac® [FLUoxetine] 20 mg by mouth, 2 capsules daily. Pt received 40 mg PROzac capsules (80 mg), which she took 2 of daily for one month. The doctor was notified by outpatient pharmacist.

A prescription for vitamin D 5,000 units daily was filled erroneously with 50,000 units daily, which the patient took for one month.

A prescription written for [methotrex-ate] 10 mg was entered as 10 tablets (25 mg dose). This prescription was refilled two more times. A [subse-quent] prescription was called in and filled correctly, but [the patient’s] mom kept giving as before. Error discovered after discussion with the patient’s mother and review of medications with her. Physician made aware of error. Confirmed that there was no patient harm.

Notified provider that he did not write out units and that the pre-scription for [insulin regular] was misunderstood as 150 units. Also, the pharmacist did not call to clarify the prescription with the provider and notified the social worker that the pre-scription could only be partially filled due to limited stock.

The pharmacist who was checking reports noticed an error [involving Lisinopril-hydroCHLOROthiazide] that perpetuated for 10 months. The physician’s office was contacted and since the patient was doing well, the decision was made to keep the dose as it had been dispensed and taken by the patient.

Wrong Dose/Under DosageUnder dosing was identified in 10.2% (n = 106) of the events. In 40.6% (n = 43) of the errors, the selected strength was half the prescribed strength. Incorrect drug strength was cited in 42.5% (n = 45) of the errors, 10.4% (n = 11) had incorrect

instructions leading to an under dose, and 4.7% (n = 5) had an incorrect quantity. More than 20% (n = 22) of the reports did not have enough information to determine the type or cause of the error. Although 78.3% (n = 83) of the errors reached the patient, only 20.8% (n = 22) of the incor-rect prescriptions were actually taken by the patient, with 11.3% (n = 12) of the patients taking the dose for at least one month. There were 71 different medica-tions involved in the errors, including lisinopril (5.7%, n = 6), levothyroxine (3.8%, n = 4), simvastatin (3.8%, n = 4), and furosemide (2.8%, n = 3).

Following are reported examples in which drugs were under dosed:

TraZODone 50 mg was processed and dispensed instead of 100 mg. The patient had trouble sleeping and noticed the pills were different but didn’t say anything. The error was caught on next refill.

The pharmacy received a prescription for tacrolimus 0.5 mg/mL electroni-cally and dose for the patient is 4 mg every 12 hours. Pharmacy filled pre-scription as tacrolimus 0.5 mg/mL, [take] 2 mL (1 mg) by mistake.

The patient was prescribed Lantus® [insulin glargine] 70 units subcutane-ous at bedtime as prescribed. The label and instructions were incorrectly listed as 30 units at bedtime. The patient has not required additional care or medication. No current lab work in computer system.

The patient’s mother called nursing for refill of medication [topiramate]. It was then discovered that the patient had been dispensed the wrong dosage and patient had been receiving wrong dose [for 3 days].

Wrong PatientWrong patient errors comprised only 8.4% (n = 88) of all events. Of these errors, 90.9% (n = 80) reached the

patient, although only two of the reports indicated that the patient had ingested the medication. Nearly 24% (n = 21) of the events occurred during the order entry phase, while 73.9% (n = 65) of the events occurred when dispensing the medications to the patient. More than a third (35.4%, n = 23) of the 65 errors that occurred when dispensing the medica-tion involved home delivery services. In fact, more than a third (37.1%, n = 23 of 62) of the events involving home delivery were wrong patient errors. Following are examples of wrong patient errors:

During the process of setting up home deliveries via courier, one patient received another’s medication via the mail, and vice versa. [The mix-up involved Xanax® (ALPRAZolam) and Truvada® (emtricitabine and tenofovir disoproxil fumarate)]. The patient realized that the patient name [printed] on the bottle was not hers and recognized the medication was not prescribed to her. She con-tacted the pharmacy and returned the medications to pharmacy via mail. The patient did not take any of the medication.

Two prescriptions were presented to staff—one for the husband and one for the wife. The husband was sup-posed to get citalopram and his wife was supposed to get metoprolol. The wife received both prescriptions in her name. She said she took one of the citalopram since her name was on it. Verified with the wife that she only took one dose. Incorrectly labeled bottle was brought back by the patient and replacement was given to her. The patient’s only complaint was that she was lightheaded and dizzy and that her blood pressure was a little elevated that day.

The patient received medication prescribed for another patient. The patient did not read label and took the medication for three months.


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DISCUSSION

There are many differences between inpatient and outpatient pharmacies. An inpatient pharmacist may fill orders for medications, monitor patient medication therapies, provide drug information, and prepare infusions. Outpatient pharma-cists provide many similar services (e.g., filling prescriptions, educating patients, administering immunizations, providing medication therapy management, calling doctor’s offices to get refills or clarify pre-scriptions) but are also tasked with calling insurance companies for reimbursement, completing transactions with customers at the point of sale, completing business reviews, and running a business.

The quantity of medication dispensed of any given prescription is different between outpatient and inpatient pharmacies. While inpatient pharmacies typically pro-vide one day’s worth of medications for a given patient in the hospital, in the outpa-tient setting, 30- and occasionally 90-day prescriptions are dispensed. Also, errors (e.g., wrong drug, wrong strength) that occur in the hospital setting have more opportunities to be caught by other prac-titioners before reaching the patient than in the outpatient setting. Outpatient dis-pensing errors frequently reach patients, who may fail to notice their prescription is not what it should be. In 12.7% (n = 33 of 259) of the wrong doses, both over and under dose, reports noted that patients took at least one dose of a medication that was not the correct strength or amount. Of these reports, 81.8% (n = 27 of 33) of the patients took at least one full month of the incorrect strength, and the error was found upon refill. In fact, 48.5% (n = 16 of 33) of patients were reported to have taken the incorrect strength for multiple months. For the wrong drug errors, 17.6% (n = 36 of 205) of patients who received the wrong drug took at least one dose of the medication, with 36.1% (n = 13 of 36) of the patients taking at least one month’s worth.

Wrong drug and wrong dose errors occurred during both the order entry and production stages of the dispensing process. Order entry is the stage in which the prescription details are entered or selected in the pharmacy computer sys-tem. Findings from other error reporting programs are similar to those identified in the events submitted to the Authority. For example, in one event, methotrexate, a high-alert medication (i.e., a medication that bears a heightened risk of harm if used in error), was incorrectly selected in the computer system instead of meto-lazone, a diuretic. The patient took the medication daily for one week until she developed mouth ulcers.6 In a second example, a wrong dose error was reported after a patient brought in a new prescrip-tion for oxyCODONE 5 mg. To expedite the dispensing process, the pharmacist copied the patient’s previous oxyCO-DONE 30 mg prescription. However, he failed to edit the product dose strength, leading to the patient receiving the wrong dose. The same pharmacist conducted the final verification immediately after completing order entry and filling the prescription, limiting the effectiveness of the check.7 Ideally, one person (e.g., phar-macy intern, pharmacy technician, second pharmacist) performs data entry for the prescription, allowing the verification pharmacist to perform a truly indepen-dent double check.

Analysts identified events in which the wrong drug or wrong strength of a medi-cation was selected from the pharmacy shelf during the production stage of the dispensing process. The production stage of the pharmacy workflow includes activi-ties such as retrieving the drug stock bottle from the pharmacy shelves, counting out the number of tablets to be dispensed, and applying the computer-generated prescription label to the prescription container. Similar medication errors have been repeatedly detailed in the literature. For example, an error occurred when the antidepressant Brintellix (vortioxetine,

brand name now Trintellix®) was retrieved from the pharmacy shelf instead of Brilinta® (ticagrelor), an antiplatelet agent. The two drugs were stored side by side, and the wrong product was selected. The patient fell and was admitted to a hospital with a periorbital hematoma after taking Brintellix for nine days.8 In another event, the incorrect strength of ARIPiprazole, an antipsychotic, was nearly dispensed to the patient. The bottles of ARIPiprazole 2 mg and ARIPiprazole 5 mg, both from the same manufacturer, looked alike with similar size, shape, color, and labeling. Additionally, the strength of each product was displayed in a small font size on the far right edge of the main panel of the label and could be missed if the bottle was turned slightly.9

Analysts identified that 8.4% (Figure 1) of the events submitted to the Authority were wrong patient errors; however, this error might be more common than indicated. A study conducted by the Institute for Safe Medication Practices (ISMP) found that a correctly filled pre-scription was given to the wrong patient at the point of sale once for every 1,000 prescriptions.10,11 With close to 4 billion prescriptions dispensed each year, an aver-age of seven wrong patient errors happens each month at every pharmacy across the United States. This number does not take into account a person getting the wrong medication because the wrong patient’s name was chosen when entering the prescription into the computer system. In addition to the potential harm from receiving another patient’s medications (e.g., administration of a contraindicated medication, omission of the correct medication, misuse of the incorrectly dis-pensed medication), a wrong patient error can result in a breach of protected health information.10

Wrong patient errors occur for several reasons. First, a mistake may be made when one patient’s medication is acci-dently placed in another patient’s bag


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for pickup.10 Another way a correctly filled medication can be given to a wrong patient is when pharmacy staff selects the wrong patient’s bag from the will call area and bypasses recommended ways of verifying a patient’s identity, such as using two patient identifiers.10 Failing to use two patient identifiers also reduces the likelihood that a pharmacy technician or pharmacist will catch wrong patient errors that occurred when entering the prescription into the computer system. Considering that only half of patients confirm their name on a prescription label, and only about three-quarters con-firm the medication’s name prior to use, this can result in a patient taking another patient’s medication.12

Another issue that predominantly affects the outpatient setting is the practice of delivering prescriptions to the patient’s home or location by courier or mail. Although delivery services can offer con-venience and help ensure homebound patients receive their medications, there are potential failure modes that could impact patient safety. The first issue is the inability to accomplish verification using two patient identifiers if the patient is not home or if the prescription is delivered by a commercial courier or through the mail. This may lead to a patient getting another person’s medication, an error identified in 35.4% of the wrong patient dispensing errors that involved delivery services. A second risk with home delivery is the decreased likelihood that the phar-macist provides education to the patient. Although a medication-information insert may be delivered to the patient with the prescription, the pharmacist is not imme-diately available to provide direct patient counseling. The pharmacist must take steps to contact and convey important medication information to the patient by telephone.13 If the medication has com-plex instructions for use or has dangerous side effects, this barrier to patient educa-tion can prove dangerous to the patient. This was the case in one event in which

a patient received a three-cycle supply of lomustine, a chemotherapeutic agent, from a mail-order pharmacy.14 However, the patient was to take one cycle’s worth of medication and then be reevaluated. To dispense the correct dose of lomustine 150 mg, the pharmacy sent three separate prescription bottles, one with 100 mg capsules, one with 40 mg capsules, and one with 10 mg capsules with the instruc-tions to take a dose from each bottle for a “total of 150 mg daily once per month as directed.” The patient, who did not receive counseling from the pharmacy, took the entire three-cycle (9 capsules) supply and died 6 weeks later. A major contributing factor to the event was that the pharmacy sent enough capsules for three cycles of therapy instead of just one.

An article published December 2016 in the Chicago Tribune highlighted the poten-tial shortcomings of current drug-drug interaction screening processes.15 For the article, reporters presented prescriptions with known contraindications to con-comitant use (e.g., a chronic cholesterol medication and an acute care antibiotic) and recorded the number of times interac-tion was missed. Among the community pharmacies presented with these prescrip-tions, the interaction was missed between 30% and 72% of the time. What makes this worrisome is that in each encounter, the prescriptions were filled at the same pharmacy. The rate of missed interac-tions and therapeutic duplications are likely to only be higher if the patient is filling prescriptions at different, unrelated pharmacies with non-interfaced computer systems (e.g., two different retail pharmacy companies, a mail order pharmacy and a local independent pharmacy). Access to the patient’s inpatient and outpatient medical record, which some hospital and health system outpatient pharmacies have, can help the pharmacists obtain a fuller picture of the patient’s health history and identify potential drug-related problem interactions and duplications.

Although automation can increase the efficiency of the dispensing process, it can also be involved in errors. There were sev-eral events submitted to the Authority in which look- or sound-alike drugs contrib-uted to wrong drug errors with the use of automation. For example, in one report, the traMADol cell or bin in the phar-macy robot was refilled incorrectly with traZODone. When wrong drug errors involving automation occur, the error can occur multiple times over the course of days, impacting multiple patients, until the error is discovered. This type of error, which can also include filling the cell with the incorrect drug strength, has also been reported in the literature. For example, a pharmacy technician inadvertently loaded one cell in a robot with two different med-ications.16 It was thought that she only scanned the first bottle of medication she added to the cell and skipped scanning the second bottle, which was a different medication. The patient discovered that the prescription vial contained two differ-ent medications and reported the error before the mistake caused any harm.

LIMITATIONS

In-depth analysis by the Authority of events involving hospital and health-system outpatient pharmacies is limited by the information reported through PA-PSRS, including the event descrip-tions. As with all reporting systems, the type and number of reports collected depend on the degree to which facil-ity reporting is accurate and complete. Although the narrative fields of the reports help analysts discern what hap-pened during the event, they often do not contain details describing how the event deviated from the standard operation, the specific stage of the pharmacy workflow process in which the error occurred, or which factors contributed to the event. It is important to note that these reports are from outpatient pharmacies affiliated with hospitals or health systems and the results of this study may not apply to other types of pharmacies.


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RISK REDUCTION STRATEGIES

One of the most important differences between the inpatient and outpatient pharmacy is the opportunity to intercept errors. Unlike inpatient settings, once an error occurs in an outpatient pharmacy, fewer healthcare practitioners handle the medication and can possibly intercept the error before it reaches the patient. The final dispensed prescription is in the control of the patient rather than a nurse or healthcare practitioner, as in an inpatient setting. Patients who do not notice an error in their prescription may continue to take the incorrect medication until either the pharmacy notices the error upon refill, or the patient experi-ences a treatment failure or other harm. This means that outpatient pharmacies and other stakeholders need to critically evaluate the systems in place, identify opportunities for improvement, and implement high-leverage risk reduction strategies. The reality that the patient is the final line of defense against error also means that outpatient pharmacies must engage patients to help identify and catch mistakes. Consider the strate-gies described below, which are based on a review of current literature, events reported to the Authority, and observa-tions from the ISMP.

Triage and Order Entry — Establish a policy that requires collec-

tion and use of the patient’s date of birth when the prescription is pre-sented to pharmacy staff and when selecting a patient in the pharmacy computer system.

— For prescriptions that are phoned to the pharmacy, use preprinted prescription phone pads that prompt the receiver to ask the caller for date of birth, allergies, and purpose of the drug.

— Flag patients with similar names in the computer system so that an alert will appear when these patients

are selected during order entry.10 If applicable, use a patient’s middle initial to differentiate patients with the same first and last name in the system. Use modifiers such as Jr. and Sr. when applicable.17

— When searching for a drug in the pharmacy computer system during order entry, type the drug name using the first four or five letters and its strength.18 Instruct pharmacy staff to not first retrieve the medica-tion stock bottle from storage and then scan the product’s barcode as a means to enter (or select) the drug in the pharmacy computer system. If the wrong product is selected from stor-age at order entry, there will be no opportunity to catch a potential drug selection error later in the dispensing process by scanning the barcode.

Production — Take the drug monograph or phar-

macy label to the shelf to get the drug and verify the National Drug Code (NDC) on the label matches the NDC on the bottle. Return drug stock bottles to shelves immediately after filling the prescription to avoid crowding the work counter.

— Implement barcode scanning to identify when the wrong product is selected from the shelf.19,20 Review compliance with barcode scanning to ensure staff complies with this safety step.19

— Require scanning of each stock bottle or package (e.g., inhaler, insulin car-ton) when more than one stock bottle or package is needed to fill a prescrip-tion or a cell in a dispensing robot.16

Verification — Use the original prescription or

an image of the original prescrip-tion when conducting verification and medication utilization review. Encourage the pharmacist to check

the data entry against the prescrip-tion rather than the vial, to guard against confirmation bias.

— For refills, check the scanned image of the original prescription, and verify the prescription is being dis-pensed correctly.21

— Enlist clinical staff to report inappro-priate or irrelevant alerts. An expert committee within the organization can review questionable or frequently overridden alerts, recommending system customizations and providing feedback to database providers.22

— Educate pharmacists on using the clinical decisions support (CDS) tools available in the pharmacy computer system. CDS tools are intended to support rather than replace the clinical judgment of the pharmacist.22

Point of Sale — Ask the patient to provide at least

two patient identifiers, including their full name and date of birth, when picking up prescriptions.10,11 This is important for all patients, even those well known to pharmacy staff. Compare the patient-provided identifiers to the information in the computer system or on the prescrip-tion receipt.

— Employ technological solutions to help ensure verification of the patient’s identity. One possibility is to build a blind prompt into the point-of-sale computer system that requires the pharmacy staff member to ask for the patient’s date of birth and then key punch it into the reg-ister.10 If the date of birth does not match the patient’s profile or is not entered, the transaction cannot be completed.

— Open the prescription bag and have the patient review the pharmacy labels and contents of each prescription container to


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verify that the medication is correct.10,11 The use of a will call system that employs clear plastic hanging bags to hold prescrip-tion containers and receipts awaiting pick up can facilitate this process.

— Provide patient education.10,11 Include a discussion of the medication’s purpose to help ensure the correct medication is being dispensed to the correct patient. When analyzing the events reported to the Author-ity, it appeared that many could have been caught if patient counseling had taken place.

— Employ scripted patient educa-tion and checklists, especially for high-alert medications, to aid in educating patients and to promote consistent discussions.6,23

— If the medication is being used off label, ensure that the patient understands why their doc-tor chose this medication for them.24,25

— Avoid asking a “yes” or “no” question when verifying the patient’s identity (e.g., by read-ing aloud the patient’s date of birth) or when providing patient education.10,13 Ask the person to supply the information so that you can confirm it. When asked “yes” or “no” questions, patients may answer “yes” and confirm the information presented was correct, only to take home someone else’s medication.

— If a friend or family member is picking up the patient’s pre-scription or it is delivered to the patient’s location, send instruc-tions for the patient to open the package at home, check the contents before taking any of the medication, and call the

pharmacist with any concerns or questions.10,13 For high-alert drugs or drugs with potentially harmful side effects, particularly if it is the first time the patient is receiving the medication, consider proactively calling the patient to review important information to reduce the risk of misuse.

Storage— Ensure stickers, labels, or

markings do not obscure the manufacturer’s barcode.26 Review inventories periodically to check that manufacturer’s barcodes are not covered up.

— Face labels forward when bot-tles are stored on the shelf.

— For look-alike products, explore ordering one of the medications from a different manufac-turer.20 Also, avoid labels that separate the strength from the product name.9 A good refer-ence to check for container label appearance is DailyMed, a service provided by the U.S. National Library of Medicine (http://dailymed.nlm.nih.gov/dailymed/index.cfm).

— Ensure look- and sound-alike names and packaging are suf-ficiently separated, regardless of normal alphabetical placement. Inform staff of the reasons for relocating these problematic drugs. Provide signage to direct staff to the storage site for relo-cated medications.20

— Use shelf dividers to keep stock separated and neatly organized on shelves.

— Add shelf talkers (a product or sign designed to call atten-tion to products on a shelf) at specific storage locations or use other strategies (e.g., Tall Man

lettering [see https://www.ismp.org/tools/tallmanletters.pdf]) to help staff identify look-alike medications or medication pairs that have been involved in dispensing errors.

Quality Processes— Have pharmacy managers or

medication safety officers peri-odically perform quality-control checks by observing the process at the different phases of the dispensing process, including the point of sale, to ensure adherence to standardized work practices.10,13

— Proactively conduct compre-hensive safety assessments of the systems in place in the pharmacy. One tool that can help pharmacies evaluate their current systems is the free 2017 Institute for Safe Medica-tion Practices Medication Safety Self Assessment® for Community/Ambulatory Pharmacy.27

— Develop and operate a con-tinuous quality improvement (CQI) program to enhance patient safety, identifying and evaluating quality-related events and constantly enhancing the efficiency and effectiveness of the structures and processes that determine the outcomes of med-ication dispensing and use.27

— Work with hospital or health-system information technology staff and health information technology vendors to establish access to the inpatient medical health record. Access to the patient’s full medical health record better enables the pharmacist to perform a full medication reconciliation and screening for interactions and duplications.


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CONCLUSION

With an estimated 64 million medica-tion errors occurring each year in the outpatient setting and an average of 87 outpatient medication errors reported to the Authority annually, the chance of a serious error harming a patient is a real possibility. In Pennsylvania 56.2%

(n = 587) of reported outpatient medication errors reached the patient. Outpatient pharmacies provide the last opportunity for a healthcare professional to intervene to ensure patients receive and take the correct medication in the correct manner. By reviewing patients’ medica-tions upon each fill and providing patient counseling, outpatient pharmacists can

make certain that patients are receiv-ing the correct therapy. Educating and empowering patients to engage in patient counseling can prepare them to serve as the final barrier in preventing errors from negatively impacting themselves and help ensure that they are getting the therapy they need.

NOTES

1. Flynn EA, Barker KN, Carnahan BJ. National observational study of prescrip-tion dispensing accuracy and safety in 50 pharmacies. J Am Pharm Assoc (Wash). 2003 Mar-Apr;43(2):191-200. PMID: 12688437.

2. Total number of retail prescription drugs filled at pharmacies (2015). [internet]. Menlo Park (CA): Henry J. Kaiser Family Foundation; [accessed 2017 Feb 20]. Avail-able: http://kff.org/other/state-indicator/total-retail-rx-drugs/?currentTimeframe=0.

3. Szeinbach S, Seoane-Vazquez E, Parekh A, Herderick M. Dispensing errors in com-munity pharmacy: perceived influence of sociotechnical factors. Int J Qual Health Care. 2007 Aug;19(4):203-9. Also avail-able: http://dx.doi.org/10.1093/intqhc/mzm018. PMID: 17567597.

4. Institute for Safe Medication Practices (ISMP). Root cause analysis workbook for community/ambulatory pharmacy. Hor-sham (PA): Institute for Safe Medication Practices (ISMP); 67 p. Also available: http://www.ismp.org/tools/rca/RCA-Complete.pdf.

5. NCC MERP index for categorizing medication errors. National Coordinating Council for Medication Error Reporting and Prevention; 2001. 1 p. Also available: http://www.nccmerp.org/sites/default/files/indexColor2001-06-12.pdf.

6. Methotrexate-metolazone mix-ups. ISMP Med Saf Alert Com/Amb. 2016 Jun;15(5):1-2.

7. Risk when copying old prescriptions. ISMP Med Saf Alert Com/Amb. 2015 Jun;14(6):1-2.

8. Name change needed to prevent more Brintellix-Brilinta mix-ups. ISMP Med Saf Alert Com/Amb. 2015 Aug;14(8):1-2.

9. Label characteristic contributes to errors. ISMP Med Saf Alert Com/Amb. 2016 Jan;15(1):3-4.

10. Open the bag to catch errors at the point-of-sale. ISMP Med Saf Alert Com/Amb. 2015 Jul;14(7):1-3.

11. Cohen MR, Smetzer JL, Westphal JE, Comden SC, Horn DM. Risk mod-els to improve safety of dispensing high-alert medications in community pharmacies. J Am Pharm Assoc. 2012 Sep-Oct;52(5):584-602. Also available: http://dx.doi.org/10.1331/JAPhA.2012.10145. PMID: 23023839.

12. Trettin KW, Narus E. Chapter 47. Imple-mentation of a VA patient-centered prescription label. In: Duffy VG, editor. Advances in Human Aspects of Health-care. Boca Raton (FL): CRC Press; 2012. p. 429-38.

13. Avoiding wrong-patient errors at the point-of-sale. ISMP Med Saf Alert Com/Amb. 2011 Feb;10(2):1-3.

14. With oral chemotherapy, we simply must do better. ISMP Med Saf Alert Com/Amb. 2014 Jul;13(7):1-4. Also available: http://www.ismp.org/Newsletters/ ambulatory/showarticle.aspx?id=8.

15. Roe S, Long R, King K. Pharmacies miss half of dangerous drug combinations. Chicago Trib 2016 Dec 15. Also available: http://www.chicagotribune.com/news/watchdog/druginteractions/ct-drug-inter-actions-pharmacy-met-20161214-story.html.

16. Robot workaround. ISMP Med Saf Alert Com/Amb. 2011 Aug;10(8):2.

17. Oops, sorry, wrong patient! A patient verification process is needed everywhere, not just at the bedside. ISMP Med Saf Alert Acute Care. 2011 Mar 10;16(5):1-5.

18. Institute for Safe Medication Practices. Look-alike generic names. ISMP Med Saf Alert Acute Care. 2016 Nov;21(22):3-4.

19. Do not let “Depo-” medications be a depot for mistakes. ISMP Med Saf Alert Com/Amb.2016 Mar;15(3):1-4.

20. Look-alike bottles. ISMP Med Saf Alert Com/Amb. 2017 Jan;16(1):2-3.

21. Always verify the original prescription when dispensing refills. ISMP Med Saf Alert Com/Amb. 2011 Feb;10(2):2.

22. Reynolds JL, Rupp MT. Improving clinical decision support in pharmacy: toward the perfect DUR alert. J Manag Care Spec Pharm. 2017;23(1):38-43. Also available: http://www.jmcp.org/DOI/abs/10.18553/JMCP.2017.23.1.38.

23. Opioid safety. ISMP Med Saf Alert Acute Care. 2014 Mar;13(5):1.

24. Safety briefs. ISMP Med Saf Alert Com/Amb. 2002 Oct;1(2):1.

25. Safety briefs. ISMP Med Saf Alert Com/Amb. 2003 May;2(4):2-3.

26. Don’t cover manufacturer’s barcode. ISMP Med Saf Alert Com/Amb. 2015 Nov;14(1):1.

27. Institute for Safe Medication Practices (ISMP). 2017 Institute for Safe Mediation Practices medication safety self assessment for community/ambulatory pharmacy. Horsham (PA): Institute for Safe Medication Practices (ISMP); 2017. 35 p. Also available: http://www.ismp.org/selfassessments/Community/2017/2017_ISMP_CommunityAmbulatory_ Pharmacy_Self_Assessment.pdf.


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Susan C. Wallace, MPH, CPHRM Patient Safety Analyst

Kelly Gipson, BSN, RN, CPPS Patient Safety Liaison

Pennsylvania Patient Safety Authority

INTRODUCTION

Patient safety officers (PSOs) from Pennsylvania facilities contacted the Pennsylvania Patient Safety Authority for information about workplace bullying to help healthcare workers address such behaviors. Bullying, a type of disrespect, is a threat to patient safety because it inhibits teamwork, obstructs communication, and impedes implemen-tation of new practices.1 A bullied healthcare worker may not speak up with pertinent clinical information or point out a safety problem to the team.2

Workplace bullying has increasingly become part of the national dialogue since the Joint Commission recommended adoption of a zero-tolerance policy toward bullying behaviors in 2008.3 The Workplace Bullying Institute defines bullying* as repeated mis-treatment of an intended target in one or more combinations of the following forms: verbal abuse; threatening, humiliating, or intimidating behaviors (including nonver-bal); or work interference (e.g., sabotage).4 The Joint Commission does not consider the following behaviors to be bullying: illegal harassment, discrimination, setting high workplace standards, having a different opinion, or giving constructive feedback.5

State legislators in 29 states, including Pennsylvania, and 2 territories have introduced bills to address workplace bullying.6 In addition, the American Nurses Association,7 the American College of Obstetricians and Gynecologists,8 and the Lucian Leape Institute at the National Patient Safety Foundation9 are among the institutions that have pub-lished position papers on this subject. The Institute for Safe Medication Practices (ISMP) conducted national surveys of healthcare workers about disrespectful behavior; results indicate that continued negative behaviors encountered by healthcare workers are influencing communication and suggest that healthcare facilities need to take fur-ther actions to address this issue.10

A 2010 Pennsylvania Patient Safety Advisory article on disruptive behavior reported delays in communication between clinicians could potentially compromise patient safety.11 The recent PSO inquiries prompted an updated analysis of events reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS), examination of the literature, and interviews of healthcare professionals who have explored this issue and taken steps towards decreasing bullying events.

METHODS

Analysts queried the PA-PSRS database for reports of events that occurred over a two-year period from July 1, 2014, through June 30, 2016, using the following keywords and derivations: bellig*, bully, coerc*, cried, cry, disrupt*, holler, in charge, intimidat*, profan*, refuse, repeated, rude, scream, threat, throw, upset, yell. The wildcard char-acter (*) ensured that the search also yielded events containing other word forms (e.g., disrupt* returns both disruptive and disruption). Events identified by relevant monitor codes to classify events were also included in the dataset.

Analysts manually reviewed the resulting set of 5,807 event report narratives to identify reports describing behaviors synonymous with bullying using the Workplace Bullying Institute definition. Event reports were then grouped into related categories by harm score, event type categories, event reporting taxonomy, and care area. Excluded were event reports addressing bullying by or toward patients.

Bullying in Healthcare: A Disruptive Force Linked to Compromised Patient Safety

ABSTRACTBullying or aggressive behaviors between healthcare providers, such as verbal abuse and intimidation, can be a threat to safe patient care. Bullying behaviors can inhibit team-work, obstruct communication, and delay implementation of new practices; it can interfere with patient care. This type of behavior may contribute to low worker morale, absenteeism, and high rates of staff turnover. A query of the Pennsylvania Patient Safety Reporting System (PA-PSRS) database revealed 44 events associated with bullying behaviors over a two-year period. Strategies to reduce bullying behaviors include scripting methods to speak up to bullying in an assertive manner, such as D.E.S.C. (i.e., describe, express, suggest, consequences); role playing through simulation to practice confront-ing a bully; instituting zero tolerance anti-bullying policies with leadership enforcement; and enhancing staff awareness of human resources and management support. (Pa Pat Saf Advis 2017 Jun; 14(2): 64-70.)

Corresponding AuthorSusan C. Wallace

* The term bullying may overlap with terms such as incivility; horizontal, lateral, or workplace violence; and unprofessional, disruptive, or disrespectful behavior.


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Analysts conducted a review of the litera-ture to identify prevalence and strategies to reduce bullying in healthcare facilities. Interviews were conducted with executive leaders, clinical practitioners, and nurse educators to identify best practices and resources to reduce bullying and patient harm.

RESULTS

Analysts identified 44 events describing bullying between healthcare providers including physicians, nurses, and techni-cians. Although analysts recognize that bullying represents repetitive behaviors over time, the examples in PA-PSRS dem-onstrate individual situations in isolation that, if repeated, could confirm bullying.

The identified events were reported in five event type categories with 56.8% (n = 25 of 44) reported in “other/miscellaneous,” followed by 27.3% (n = 12) reported in “error related to procedure/treatment/test” (Table 1).

Most of the events described overt bully-ing with no direct patient harm. Analysts found 77.3% (n = 34) of the PA-PSRS events involved a physician engaging in verbally abusive behavior. The remaining events (n = 10) involved a nurse or techni-cian. Twenty-seven percent (n = 12) of the events were witnessed by a patient.

Examination of event descriptions revealed five categories of bullying behav-iors based on the Workplace Bullying Institute definition. Analysts assigned some events to more than one category, resulting in 92 entries. The top two event categories in order of frequency were verbal abuse and intimidating behaviors (Table 2).

Analysis of care areas where bullying events were identified revealed three top areas where the events occurred: periop-erative care areas 29.5% (n = 13 of 44); medical/surgical units 25.0% (n = 11); and the emergency department 15.9% (n = 7; Figure).

Bullying EventsAnalysts interviewed a healthcare pro-vider who spoke to the Authority on the condition of anonymity and described a bullying situation over the course of 15 years involving a nursing supervisor.12 She described the supervisor as harsh and abrupt with others, who used condescend-ing tones, eye rolling, and deep sighing when new workers did not understand instructions.

At least two nurses left their positions in a month’s time after working with the supervisor, while other workers were afraid and avoided working with the individual, she said. Some repeat patients would request another nurse and indi-cated on questionnaires that the nurse was “mean,” she said.12 When the supervi-sor’s behavior was brought to leadership’s attention, the nurse said, it was not addressed. “We were told that this is just the way she is,” she said.

Examples of bullying events reported to the Authority in PA-PSRS are presented by category, as follows:*

Verbal abuse

Night nurse yelled at other nurses with a negative and aggressive atti-tude after she was questioned about her documentation of assessments done during her shift. She stated, “How dare I question her” after ask-ing for the information.

The radiology technician yelled at the nursing staff for not entering the procedure correctly [into the electronic health record]. This took place in front of the patient.

Table 2. Bullying Events by Description of Event* (N = 44)

CATEGORIES NUMBER OF EVENTS PERCENTAGE

Verbal abuse (e.g., rude behavior) 34 77.3

Intimidating behaviors (e.g., badgering) 32 72.7

Work interference (e.g., sabotage) 13 29.5

Humiliating behaviors (e.g., mimicking) 7 15.9

Threatening behaviors (e.g., frightening) 6 13.6

Note: As reported to the Pennsylvania Patient Safety Authority, July 1, 2014, through June 30, 2016.* These events total more than 100% because some reports described more than one event category.

Table 1. Bullying Events by Event Type* (N = 44)

EVENT TYPE NO. (%) OF EVENTS

Error related to procedure/treatment/test 12 (27.3)

Complication of procedure/treatment/test 5 (11.4)

Medication error 1 (2.3)

Transfusion 1 (2.3)

Other/miscellaneous 25 (56.8)

Note: As reported to the Pennsylvania Patient Safety Authority, July 1, 2014, through June 30, 2016.* Event types are defined by Pennsylvania Patient Safety Reporting System taxonomy and are assigned to events by healthcare facilities at the time of report submission.

* The details of the PA-PSRS event narratives in this article have been modified to preserve confidentiality. None of these specific event narratives came from facilities interviewed for this article.


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Intimidating behaviors

Patient admitted with bleeding and needed an order and consent for a blood transfusion. Physician refused to speak to the patient to obtain the consent and told the nurse that it would be the nurse’s fault if the patient dies. He repeated his order and hung up the phone.

Patient had been transferred from the cardiac care unit with stable vital signs. The patient’s pulse became irregular and blood pressure dropped. Patient was otherwise without symp-toms. [The nurse] called the physician and informed him of change in vital signs, and asked him if he wanted a cardiology consult. [The physician] told nurse several times [the nurse] was incompetent, never to call him

again and tell him what to do. No new orders were given.

Work interference

Physician was notified of a patient injury by the charge nurse. Due to a miscommunication about which patient was involved with the event, the physician thought the patient was a new admission. Physician fired off multiple questions and would not allow the nurse to answer her inquiries. The nurse tried again to give appropriate information about the injury [using the facility-approved format] and the physician again inter-rupted the nurse.

Nurse asked physician to perform medication reconciliation together [to prepare a patient for discharge] and physician refused. The nurse attempted to go through the list; however, the physician continued to

interrupt the nurse and stated every-thing was fine.

Threatening behaviors

Surgeon insisted on modifying equipment in a manner that was against hospital policy. After lengthy arguments between the healthcare workers, the surgeon refused to perform the procedure unless the modifications were made. The nurse stated she was being forced to practice contrary to hospital policy.

Humiliating behaviors

Nurse asked physician to re-sign a consent form since there was no wit-ness for the original consent. Instead of signing the form where it was indi-cated, the physician signed it on the witness line and stated to the nurse, “There, you have a witness.”

DISCUSSION

Impact of Bullying on Patient SafetyOf the 44 bullying events reported to PA-PSRS from July 1, 2014, through June 30, 2016, most occurred in the periop-erative area, involved physicians as the perpetrators, and included verbal abuse and intimidating behaviors. The small number of events reports over the two-year period may reflect a lack of recognition of bullying behaviors, particularly if they are covert; a reluctance to report for fear of retribution; and absence of a PA-PSRS category for bullying as it relates to patient safety.

Leape and colleagues propose that disre-spectful behavior causes the dysfunctional culture found in healthcare and inhibits progress in patient safety.1 He attributes this to the high stress environment found in healthcare, the hierarchical structure of the workforce, and the autonomous behavior of professionals who resist following safe practices.1 Disruptive behaviors can affect one’s ability to think clearly, making unsafe acts and errors more likely. Caregivers may even divert

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354

CARE AREA

NUMBER OF REPORTS

0 2 4 6 8 10 12 14

13(29.5%)

11(25.0%)

7(15.9%)

4(9.1%)

3(6.8%)

2(4.5%)

2(4.5%)

1(2.3%)

1(2.3%)Radiology

Cardiac intensive care unit

Transitional/step-down units

Labor and delivery units

Non-nursing clinical areas

Cardiac(invasive and noninvasive)

Emergency departments

Medical/surgical units

Perioperative care areas

Figure. Bullying Events By Care Area (N = 44)

Note: As reported to the Pennsylvania Patient Safety Authority, July 1, 2014, through June 30, 2016.


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their attention from the patient to that of self-protection, as evidenced by avoidance of the instigator.1 Bullying may inhibit cross-monitoring by team members who are reluctant to speak up.13

Understanding prevalence and con-

sequences. The Workplace Bullying Institute estimates that 27% of adult Americans have experienced workplace bullying and another 21% have witnessed it.14 A Joint Commission survey found 50% of nurses were victims of disruptive behaviors and 90% witnessed these behav-iors.3 Other researchers state the true number of bullying events is unknown, because it is often unrecognized and underreported.15

In ISMP’s 2013 survey, 4,884 healthcare workers (i.e., physicians, nurses, pharma-cists, quality/risk managers) responded that disrespectful behaviors most often encountered were as follows:16

— Negative comments about colleagues (73%)

— Reluctance or refusal to answer ques-tions or return calls (77%)

— Condescending language or demean-ing comments or insults (68%)

— Impatience with questions or hang-ing up the phone (69%)

— Reluctance to follow safety practices or work collaboratively (66%)

Compared with survey results from 10 years earlier, ISMP found disrespectful behaviors continue to be prevalent, with little improvement.10

Bullied workers may experience humili-ation and powerlessness in response to behaviors that range from the overt such as verbal outbursts and physical threats, to the subtle or covert such as eye rolling or purposefully holding back patient information.3,14 Bullying behaviors may contribute to low worker morale, absenteeism, and high rates of turnover of highly qualified staff.3,5 There is also a financial cost associated with bullying

such as training new staff, which is esti-mated at $100,000 per new hire.17

Evaluating the culture. In an interview with the Authority, Grena Porto, RN, ARM, CPHRM, vice president, risk man-agement, ESIS ProClaim, and a member of the Joint Commission’s Patient Safety Advisory Group, stated that as recently as 10 years ago, few people thought of bully-ing as a patient safety issue.13 Porto, who was instrumental in developing the Joint Commission’s Sentinel Event Alert on this topic, also stated that today, no one questions that bullying and other disrup-tive behaviors have a profound impact on patient safety.13

Hospitals can take the first step to deter-mine how bullying impacts patient safety in their facility, by administering the AHRQ (Agency for Healthcare Research and Quality) survey on the patient safety culture, which can be accessed at http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/index.html. Porto also recommends conducting focus groups of healthcare workers from various shifts and departments to gain a clearer understanding of the culture.13

Bullying on the Frontline. Bullying can occur in all areas of healthcare. It takes strong medical-staff leadership to tackle disruptive physician behavior, Porto said. “Depending on the situation, it may just mean sitting down with the physician over coffee,” she said. More serious episodes of bullying or repeated patterns of bullying behavior may require a stronger approach, including discipline and termination as appropriate.13 It is important to intervene early, tailor actions to the situation, and ensure that medical leaders are actively involved in the process, she said.13

Studies show yelling, insulting other healthcare workers usually of lesser status (i.e., medical students), and refusing to follow established policies are the most common types of behaviors reported for physicians.9 Behaviors of physicians found by analysis of the PA-PSRS events

included shouting and insulting language directed towards others in supporting positions (e.g., nurses, technicians).

Nurses can be compassionate to patients, but may also be “horrific” to each other, according to Renee Thompson, DNP, RN, CMSRN, CEO and president of RTConnections, LLC, based in Pittsburgh.18 Thompson, an author and expert about nurse bullying, said, “Every single day of my life, a nurse reaches out to me about being a target of bullying.”

Nurses work in extremely stressful situa-tions in which they are dealing with life and death in unpredictable circumstances, Thompson said.18 “We haven’t taught nurses good coping mechanisms,” she said. “So they lash out at each other and then that becomes their pattern.”

Working with a bully can be a huge distractor that impacts patient safety, Thompson said.18 “How can you really focus on your patient if you are worried about keeping out of harm’s way of the bully,” she said. “If you are uncomfort-able about being open and honest with someone, how can you share information about your patients? It stops the flow of information.”

Thompson advocates for training manag-ers about bullying behaviors.18 Frontline managers determine the culture in the nursing unit, but no one is teaching the frontline managers how to set expecta-tions with the staff, how to hold people accountable, and how to create a culture of professionalism, she said.

The Role of LeadershipLeadership support is crucial in intro-ducing, setting policy, and maintaining a successful anti-bullying program.3,13,18 Kendra Aucker, president and CEO, Evangelical Community Hospital, Lewisburg, PA, discovered that 30% of the employees who completed a sur-vey in 2015 measuring the “culture of respect” answered that abusive behavior


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was tolerated at the hospital, 25% were frequently bullied, and 40% found it unpleasant to work with other depart-ments.19 “I read this and couldn’t believe it,” she said. “I thought this was unaccept-able and we have to start now to address this.”

Aucker introduced policies on anti-bullying and respectful workplaces (http://patientsafety.pa.gov/pst/Pages/PSAPatientSafetyTopicList.aspx) for every level of the organization to help establish a safety system and culture.19 In addition, she met with about 1,100 employees over several months in informal meetings entitled “Coffee with Kendra” to get firsthand insight into the culture. “I was told about outbursts, shouting, passive-aggressive behaviors, and other ways we treated one another,” she said. “We would never achieve a higher level of patient care unless we changed our attitudes and our behaviors. There is an expectation in the way you treat the people you work with, and that translates to how you treat the people you care for.”

She worked in committees to alleviate some of the system problems causing frus-trations that lead to bullying behaviors, focused on the departments with the lowest survey scores, instituted training programs for staff and managers, wrote about the improvements in e-mail blasts, and talked about the issues in a “state of the union” address.19

With someone willing to listen and deter-mined to make changes, Aucker said, staff began speaking out about situations that could jeopardize patient safety. “The patient is the center of all that we do, and that includes our behavior,” she said.19 If employees could not change their behav-iors, then this was not the organization for them anymore, she said. A year after the survey, Aucker said improvement was mea-sured with an employee engagement survey, which found a 38% decrease in the per-centage of employees who felt disengaged.

“I am very proud of the work force,” she said. “Behavior isn’t always black and white, but you have to feel free to speak up and stand up for yourself if you feel you are a victim of bullying or bad behav-ior. You have to take responsibility for yourself and other people. While there is still lots of work to be done, patients are talking to us about how kind and helpful staff are to them.”19

It is imperative that hospitals develop a leadership team, including middle manag-ers and unit managers who can lead by example and model the desired behaviors, Porto said. “It is critical to understand that even managers and senior leaders are capable of bullying behavior, and organi-zations who fail to identify and address such behaviors in leaders cannot succeed in establishing a culture of safety,” Porto said.13

LimitationsLimitations of this study include scant detail in some PA-PSRS reports, the potential to misinterpret information in the narrative descriptions in the reports, and the possibility that reporters used terms not included in the search strat-egy. Although analysts recognize that bullying represents repetitive behaviors, PA-PSRS events demonstrate individual situations in isolation that, if repeated, could confirm bullying. Events may not be recognized as reportable by frontline staff if bullying is viewed as “normalized” behavior, because of the lack of a struc-tured data field for reporting bullying or employee events or because of fear of retribution. Bullying events, especially those in which there is physical harm between providers, may be reported as an Infrastructure Failure, which is not reported to the Authority.

RISK REDUCTION STRATEGIES

The following strategies suggested in the literature, and by anti-bullying groups and professionals, may be useful to healthcare

workers, managers, and senior leaders seeking to reduce bullying and other dis-ruptive behaviors.

All Healthcare Workers — Report and document bullying

behaviors through established protocols.20

— Review personal behaviors (e.g., do you sometimes ridicule or joke about a new or inexperienced co-worker?) and take steps to modify these behaviors (e.g., seek out an Employee Assistance Program.)18

— Learn scripting techniques to help stop a bullying situation such as D.E.S.C. (i.e., describe, express, sug-gest, consequences).21

— Think about strategies to handle a bullying situation (e.g., staff members feeling tensions rising, can call out, “Tempo!” as a reminder for everyone to calm down, or when a bullying situation occurs, have workers notify others so they can stand beside and support the bullied worker).22

— Know your healthcare facility’s policy and procedure on bullying, so you can refer to it and seek help, as needed.20

Managers — Observe staff at work and dur-

ing key interactions such as change-of-shift reports to identify patterns of unacceptable behavior or communication.13

— Appoint preceptors who will uphold a zero-tolerance policy for bullying behaviors and can serve as a resource for those on the receiving end of bul-lying behavior.13,23

— Ask senior leaders for educational classes on bullying for staff and managers.20

— Engage organizational staff mem-bers with expertise in this area (e.g., human resources experts) to be avail-able to staff, as needed.23


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— Know your facility’s policy and procedure addressing bullying, and enforce it in your department.20

— Place posters and fact sheets about bullying in your break and locker rooms.13,18

— Ensure each bullying incident is resolved in a manner that protects the person being targeted and enhances the overall unit or depart-mental culture.24

Senior Leaders — “Declare a new day” by not letting

past events disrupt new efforts, and move forward regardless of past events.25

— Survey the staff to establish a base-line about bullying behaviors in your facility and conduct ongoing monitoring.13,19

— Develop or review existing poli-cies and procedures on bullying, and make sure they follow current

state and federal standards and professional behavior standards.3,20 Recommended elements include zero tolerance, non-retaliation towards those who report/cooper-ate in investigations, responding to witness (e.g., patients), and defining disciplinary actions.3

— Ask for input from staff to ensure staff co-owns the process and expectations.23

— Establish a multi-disciplinary com-mittee of senior leaders, managers, and healthcare workers to review bullying events.3,10

— Encourage employees to report incidents of bullying, and provide feedback on these behaviors to all employees.19

— Offer educational programs on strategies for conflict resolution and encourage employees to participate.3

— Lead by example and model non-bullying behaviors.13

CONCLUSION

Analysts identified 44 bullying events reported through PA-PSRS over a two-year period; most occurred in the peri-operative area and were overt actions such as verbal abuse and intimidating behaviors. Limitations of reporting bully-ing behaviors are discussed and include lack of recognition of bullying behaviors, particularly if they are covert, and a reluc-tance to report for fear of retribution. Bullying behaviors may threaten the safe care of patients by inhibiting teamwork, obstructing communication, and delaying implementation of new practices. Studies show that bullying decreases morale and increases absenteeism and turnover of highly qualified staff. Studies suggest that hospitals take a focused look at these behaviors and institute effective policies with leadership support, educate staff and managers to recognize and handle bully-ing situations, and involve medical staff leadership.

NOTES

1. Leape LL, Shore MF, Dienstag JL, Mayer RJ, Edgman-Levitan S, Meyer GS, Healy GB. Perspective: a culture of respect, part 1: the nature and causes of disrespectful behavior by physicians. Acad Med. 2012 Jul;87(7):845-52. Also available: http://dx.doi.org/10.1097/ACM.0b013e318258338d. PMID: 22622217

2. Patterson K, Grenny J, McMillan R, Switzler A. Crucial conversations: tools for talking when stakes are high. 2nd ed. New York (NY): McGraw-Hill; 2012.

3. Behaviors that undermine a culture of safety. The Joint Commission; 2008 Jul 9. 3 p. (Sentinel Event Alert; vol. 40, Also available: https://www.jointcommission.org/assets/1/18/SEA_40.PDF.

4. The healthy workplace bill: the problem. [internet]. Workplace Bullying Institute; 2016 [accessed 2016 Dec 30]. [3 p]. Avail-able: http://healthyworkplacebill.org/problem/.

5. The Joint Commission. Bullying has no place in health care. Quick Saf. 2016 Jun;(24):1-4. Also available: https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_24_June_2016.pdf.

6. The healthy workplace bill: the states. [internet]. Workplace Bullying Institute; 2016 [accessed 2016 Dec 30]. [2 p]. Available: http://healthyworkplacebill.org/states/.

7. ANA position statement: Incivility, bullying, and workplace violence. Silver Spring (MD): American Nurses Association, Inc. (ANA); 2015 Jul 22. Also available: http://www.nursing-world.org/MainMenuCategories/WorkplaceSafety/Healthy-Nurse/bullyingworkplaceviolence/Incivility-Bullying-and-Workplace-Violence.html.

8. Committee on Patient Safety and Quality Improvement. Behavior that undermines a culture of safety. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2017 Jan. 4 p. (ACOG Committee Opinion;

no.683). Also available: http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Patient-Safety-and-Quality-Improvement/Behavior-That-Undermines-a-Culture-of-Safety.

9. Lucian Leape Institute. Through the eyes of the workforce: creating joy, mean-ing, and safer health care. Boston (MA): National Patient Safety Foundation; 2013. 40 p. Also available: http://www.npsf.org/?page=throughtheeyes.

10. Part II: Disrespectful behaviors their impact, why they arise and persist, and how to address them. ISMP Med Saf Alert. 2014 Apr 24;19(8):1-4. Also avail-able: http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=78.

11. Chain of command: when disruptive behavior affects communication and teamwork. Pa Patient Saf Advis. 2010 Jun 16;7 (Suppl 2):4-13. Also available: http://patientsafety.pa.gov/ADVISO-RIES/Pages/2010sup2_04.aspx.


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12. Anonymous. Conversation with: Pennsyl-vania Patient Safety Authority. 2016 Nov 1.

13. Porto G. (Vice president, risk manage-ment, ESIS ProClaim). Conversation with: Pennsylvania Patient Safety Author-ity. 2016 Nov 16.

14. Namie G, Christensen D, Phillips D. 2014 WBI U.S. Workplace Bullying Survey. Workplace Bullying Institute; 2014. 19 p.

15. Becher J, Visovsky C. Horizontal violence in nursing. Medsurg Nurs. 2012 Jul-Aug;21(4):210-3, 232. PMID: 22966523

16. Unresolved disrespectful behavior in healthcare practitioners speak up (again)-Part I. ISMP Med Saf Alert - Acute Care. 2013 Oct 3;18(20) Also available: http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=60.

17. Hubbard P. What can be done about hori-zontal violence? Alta RN. 2014;69(4):16-8. PMID: 24730120

18. Thompson R. (CEO and president, RTConnections, LLC). Conversation with: Pennsylvania Patient Safety Author-ity. 2016 Nov 17.

19. Aucker K. (President, CEO, Evangelical Community Hospital, Lewisburg, PA). Conversation with: Pennsylvania Patient Safety Authority. 2016 Oct 28.

20. ANA sets ‘zero tolerance’ policy for workplace violence, bullying. Position statement calls on health care employ-ers to implement violence prevention programs. Ala Nurse. 2015 Dec;42(4):17. PMID: 26749947

21. TeamSTEPPS® 2.0 Pocket Guide. (AHRQ Publication No. 14-0001-2). Rockville (MD): Agency for Healthcare Research and Quality; 2013 Dec. DESC Script. p. 31. Also available: http://www.ahrq.gov/teamstepps/instructor/ essentials/pocketguide.html#descscript.

22. Thompson R. What if the nurse bully is you? [internet]. Ft. Lauderdale (FL): NurseTogether.com; 2015 May 31 [accessed 2016 Dec 30]. [1]. Available: http://www.nursetogether.com/what-if-the-nurse-bully-is-you.

23. AONE Guiding Principles: mitigating violence in the workforce. Chicago (IL): American Organization of Nurse Execu-tives (AONE); 2014. 5 p. Also available: http://www.aone.org/resources/mitigat-ing-workplace-violence.pdf.

24. Johnson SL, Boutain DM, Tsai JH, Beaton R, de Castro AB. An exploration of managers’ discourses of workplace bullying. Nurs Forum (Auckl). 2015 Oct-Dec;50(4):265-73. Also available: http://dx.doi.org/10.1111/nuf.12116. PMID: 25597260

25. Porto G. Reining in a disruptive clinician. OR Nurse 2010. 2010 Nov;4(6):5-8.

Pennsylvania Patient Safety Advisory Page 71Vol. 14, No. 2—June 2017©2017 Pennsylvania Patient Safety Authority

INTRODUCTION

Imagine a basic tool used for performing a task, such as a chisel. The chisel is a raw powerful tool that one strikes with a hammer, commonly used for removing large chunks of material. A chisel has a handle for stabilization, a striking surface, and a flat, angled cutting edge. Not complex or compound, the chisel nowadays is usually fabri-cated from a single piece of hard metal, is easy to wipe off and sharpen, and maintains its cutting edge for long periods of use, requiring little maintenance. Now, imagine a tool designed for cutting delicate objects, such as a small pair of scissors. The chisel has one cutting edge that moves in one direction, whereas scissors have two cutting edges that move in opposite directions, requiring the addition of a hinge pin. The scissors require sharpening of two indexing edges, lubrication of the hinge pin, and a specific interface with the operator through the two handles. As the precision of work increases, tools seem to become more complex and require more care for proper opera-tion. Care and maintenance of complex tools, in turn, directly affects the quality of work when the tool is used.

The same principles can be applied to tools used for operations and procedures con-ducted on living beings. Tools evolve into instruments and devices as the complexity, delicateness, and success of a procedure increase, and their use directly influences a patient’s real or perceived wellbeing. The straight Hibbs chisel, used in orthopedic sur-gery to remove large pieces of bone, is made of smooth, high-quality stainless steel; with no material gaps, channels, or overlaps, and it is easy to clean, disinfect, and maintain. Compare the Hibbs chisel to the Pratt-Smith hemostatic forceps (Pratt hemostat), with the Pratt’s T-shaped, tube-like tip with precise, fine, serrated jaws, ratcheting handle, and smooth hinge action (see Figure 1). Based on its design and intended function (clamping delicate tissue) the Pratt hemostat has more nooks and crannies that are dif-ficult to adequately reprocess and facilitate the accumulation of bioburden. Thus, the design of medical devices, equipment, and instruments may provide ideal spaces for bioburden accumulation, and subsequent development of biofilm, especially if com-pound hinges, gaps, channels, or lumens are present.

BioburdenBioburden is “the degree of microbial contamination or microbial load; the number of microorganisms contaminating an object.”1 Colloquial clinical use of the term bio-burden includes both microscopic debris and debris that is visible to the naked eye and refers to tissue, body fluids, bacteria, or any other biologic material present on, or in, an instrument or device after use on, or in, a patient. Varying degrees of bioburden will be present on an object after use on a patient; the accumulation of bioburden on used equipment is unavoidable. Once bioburden is present on a surface, biofilm formation is not far behind.

BiofilmSurface bioburden to any degree facilitates the formation of biofilm. Biofilm is “a slime-enclosed community of bacterial colonies that is very difficult to eradicate even with the most powerful antibiotics or sterilizing systems. Biofilms can occur on any body surface, on teeth (as dental plaque), medical equipment, medical tubing, contact lenses and elsewhere.”2 It is important to note that biofilms can be visible to the naked eye in an aquatic or industrial environment, for example when pipes are fouled, but biofilms can also be microscopic and can develop on the surfaces of medical devices and equipment very rapidly (within minutes).3

Retained Bioburden On Surgical Instruments After Reprocessing: Are We Just Scraping the Surface?

ABSTRACTThe design of medical devices, equip-ment, and instruments can provide ideal spaces for bioburden accumula-tion and subsequent development of surface biofilms, especially if compound hinges, gaps, channels, or lumens are present. Many outcomes related to the use of poor-quality instruments are likely to go unrecognized, especially if the result of an event is latent in a patient’s course. To increase knowledge about the prevalence of reported events related to issues with surgical instru-ments, Authority analysts queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) database for acute care events associated with bioburden on surgical instruments reported from January 1, 2005, through December 31, 2015. Analysts then compared the results with Pennsylvania Health Care Cost Containment Council (PHC4) acute-care procedural denominator data from the same time frame. The results show an increase in the number of reported events over time, both in the number of reports per year and as a rate per 1,000 procedures. To combat the trend of increased bioburden preva-lence, a quality improvement initiative in surgical instrument reprocessing may need to occur. The operating room and its patients depend on the reprocessing department; operating room services simply cannot exist without an adequate flow of clean and sterile surgical instru-ments and equipment. Efforts should be considered to unify departments and processes around the care and main-tenance of mission-critical items, such as surgical instruments, devices, and equipment. (Pa Pat Saf Advis 2017 Jun; 14(2): 71-75.)

James Davis, MSN, RN, CCRN, CIC, HEM, FAPIC Senior Infection Prevention Analyst


F O C U S O N I N F E C T I O N P R E V E N T I O N

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Healthcare-Associated Infection and EndotoxinThe published literature has examples of healthcare-associated infections (HAIs) linked to instruments and equipment that have been processed appropriately but, because of their design, have proved to be difficult to clean and disinfect or steril-ize despite following the manufacturer’s cleaning instructions.4 Furthermore, there is evidence of infection transmis-sion when cleaning and sterilization procedures have not been adhered to, or where quality control has been poor.5 Several researchers have also noted the risk of endotoxin presence on surgical instruments, which may contribute to orthopedic prostheses loosening.6,7 The risk of complications and frequency of these types of events is difficult to deter-mine; peer-reviewed literature addressing the topic is lacking. Many adverse out-comes related to the use of poor quality instruments are likely to go unrecognized, especially if the result of an event is latent in a patient’s course.

METHODSTo help inform healthcare facilities about the prevalence of inadequate reprocessing of surgical instruments, Authority analysts queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) database to identify acute-care event reports associated with bioburden on surgical instruments reported from January 1, 2005, through December 31, 2015. The end of 2015 was the last complete data set at the time of the query for all data sets. Analysts then compared the resultant trend identified within PA-PSRS data with Pennsylvania Health Care Cost Containment Council (PHC4)* acute care procedural denomi-nator data within the same time frame to account for potential artifact within

PA-PSRS data, in the event that increased volume reporting affected prevalence trends. The PHC4 acute care procedural denominator data report was produced using operating room revenue codes within a claim record to capture and count the number of operating room revenue codes per claim record thereby arriving at the denominator of inpatient claim records. PA-PSRS event reports include a free-text narrative section for reporters to augment the event report. Analysts also compared reports and narra-tives to discern any recurrent themes.

Authority analysts interviewed six indi-vidual operating room clinicians from four hospitals in different regions in Pennsylvania. The interviewees were informed that the Authority had received reports of surgical instruments with bioburden and or debris present after reprocessing that were for use in operat-ing rooms. Interviewees were asked to describe rationales and possible explana-tions that they believed contributed to these events. Interviewees agreed to speak with the Authority on a guarantee of com-plete anonymity for themselves and their institutions. Interviews were conducted via phone and were structured in an open format without specific questions posed by the analyst.

RESULTS

Quantitative ResultsFigure 2 shows a general increase in the number of bioburden related events reported through PA-PSRS during the years 2005–2015. Figure 3 shows the rate of reported events per 1,000 inpatient claim records per year. Figure 3 mimics the trend identified in Figure 2 and dem-onstrates a general increase in bioburden prevalence per year, accounting for the number of patients. Figure 4 displays the rate of bioburden reports per 1,000 inpa-tient claim records by event type per year. Figure 4 further validates the initial trend of an increased bioburden prevalence over time isolated within PA-PSRS data.

The Hibbs Chisel has no areas that are difficult to clean and sterilize.

In contrast, areas on the Pratt Hemostat can be difficult to clean and sterilize, especially if processed without using a stringer.

MS17350

Figure 1. The Hibbs Chisel verses the Pratt Hemostat

* The Pennsylvania Health Care Cost Contain-ment Council (PHC4) is an independent state agency responsible for addressing the problem of escalating health costs, ensuring the quality of health care, and increasing access to health care for all citizens. While PHC4 has provided data for this study, PHC4 specifically disclaims responsibility for any analyses, interpretations, or conclusions.


Qualitative ExamplesThe following narratives from events reported through PA-PSRS are examples of the adverse impact ineffective cleaning and sterilization procedures can have in a clinical setting:*

Loaner instruments ran through washer decontaminator then wrapped and run through sterilizer. While setting up, staff noticed dried blood on the set.

While pushing bone graft into the instrument, a large piece of dried tissue from a previous case came out onto the field, contaminating the patient’s bone graft and set-up.

Debris from a prior procedure dislodged from the endoscope and floated into the ventricle, unable to retrieve. Ventricle flushed and patient placed on antibiotics.

Laminectomy with local bone graft. Staff noted that a sterilized instrument pan containing spinal instruments was found to be contami-nated with old bone and tissue from a previous case. The case was delayed.

Fragments of bone cement were observed in the patient’s knee, and the surgeon had not used cement. The scrub nurse noticed the instrument impactor in the set had cement from a previous case on it. Wound class was changed from 1 to 2.

Interview ResultsThe following problematic, common themes emerged during interviews with six individuals involved in surgical instru-ment reprocessing and use:

— Reprocessing staffing patterns not aligned with increases in surgical case loads

* The details of the PA-PSRS event narratives in this article have been modified to preserve confidentiality.

NUMBER OF REPORTS

YEAR2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

J. Other/MiscellaneousF. Complication of Procedure/Treatment/TestE. Error related to Procedure/Treatment/TestC. Equipment/Supplies/Devices

Event type

MS17351

0

50

100

150

200

250

300

84

44

15

52

49

42

56

36

35

77

59

32

173

79

56

126

62

65

1211

40

76

1311

65

82

1816

71

137

2013

81

151

20

21

89

106

Figure 2. Number of Bioburden Reports by Event Type

Note: Data submitted to the Pennsylvania Patient Safety Authority, 2005–2015.

RATE PER 1,000 INPATIENT CLAIM RECORDS

YEAR

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

MS17352

0.122

0.1670.140

0.179

0.262 0.249 0.241

0.306

0.434

0.488

0.443

0.0

0.1

0.2

0.3

0.4

0.5

Figure 3. Rate of Bioburden per 1,000 Inpatient Claim Records





— Unrealistic expectations related to reprocessing production pressure (demands for quicker turnaround of instruments)

— Subpar levels of surgical instrument stock

— Re-processors’ unfamiliarity with manufacturer’s instructions for use and care of instruments

— Operating room staff not con-sistently wiping, precleaning, or soaking instruments prior to sending for reprocessing

— Used surgical instrument trays sitting for prolonged periods of time before being sent for reprocessing

— The operating room and repro-cessing departments treated as separate teams—a lack of cohesive-ness between departments

— Lack of standardized training and education

— Poor workflow design in the repro-cessing department

— Inconsistent auditing of process mea-sures and quality indicators

When considering the quantitative and qualitative data, the explanations provided by the interviewees seem to deserve inves-tigation for quality improvement because the prevalence of events shows an upward trend over time. All interviewees stated that their individual hospitals were aware of and actively addressing the issue of surgical-instrument reprocessing quality.

LIMITATIONS

Limitations of PHC4 data on the pro-cedural denominator data report as per PHC4:8

“PHC4 data captures procedures that are performed per patient claim record. Also included on the claim record, when

applicable, are operating room revenue codes. The report was produced using operating room revenue codes within a claim record to capture and count the number of operating room revenue codes per claim record. One inpatient claim record may have one or more operating room revenue code associated with one or more procedures performed on the same day. For example, a hospitalized patient who had 6-procedures during the same day may have two operating room revenue codes reported/counted (one for general operating room service and another for minor operating room surgery).”

The analysts note the limitations of the PHC4 data collection method by using claim records and revenue codes. Thus, the bioburden rates per surgical procedure shown in Figure 4 might be lower than typical instrument bioburden prevalence per procedure in a clinical setting.

The Authority acknowledges that the interview data is of a limited nature and likely does not represent all conditions across Pennsylvania.

DISCUSSION

High-quality reprocessing of surgical instruments and equipment is a mission critical task. Although the interview evi-dence is limited, it must be considered that all interviewees noted some amount of separation and discordance between the operating room and reprocessing departments. The operating room and its patients depend on the reprocessing department; operating room services cannot exist without an adequate flow of quality surgical instruments and equip-ment. Efforts can be considered to unify departments and processes around the care and maintenance of mission criti-cal items, such as surgical instruments, devices, and equipment.

Figure 4. Rate of Bioburden per 1,000 Inpatient Claim Records, by Event Type

YEAR2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

J. Other/MiscellaneousF. Complication of Procedure/Treatment/TestE. Error related to Procedure/Treatment/TestC. Equipment/Supplies/Devices

Event type

RATE PER 1,000 INPATIENT CLAIM RECORDS

MS17353

0.0

0.1

0.2

0.3

0.4

0.5

.014

.007

.075

.026

.009

.003

.084

.072

.009

.010

.061

.060

.012

.012

.101

.055

.029

.005

.134

.095

.021

.010

.106

.111

.021.019

.069

.132

.023

.020

.116

.147

.032

.029

.127

.246

.037

.024

.149

.278

.038

.039

.167

.199



As demonstrated by the examples of the Hibbs chisel and Pratt hemostat, surgical equipment comes in all shapes and sizes, with varying levels of complexity. Based on the design and complexity level, some instruments may be inherently easier to clean and subsequently disinfect or sterilize appropriately. Reprocessing and operat-ing room staff need to have access to each instrument’s instructions for use that include particular methods for cleaning, care, disinfection, sterilization, and mainte-nance. As noted in the results, there have been many reports of debris lodged on and inside instruments, especially those with gaps, lumens, and channels. Once debris dries inside or on an instrument surface, the instrument becomes increasingly dif-ficult to clean; thus when cleaning starts at the point of use (in the operating room), removing debris at the point of reprocess-ing becomes more effective.9

Equipment design plays a vital role in determining how easily an effective, high-quality reprocessing method can be accomplished. There are examples in

the literature of infection transmission occurring after a device was processed according to the manufacturer’s instruc-tions, essentially due to device design that made adequate reprocessing dif-ficult.4 When purchasing equipment and instruments, the design and the entire use, reprocessing, and reuse cycle should be considered. An optimal approach would bring all users of an instrument to the table during the evaluation for purchase, to gather input on the features and design of the device. If reprocess-ing staff point out that the design of a device is problematic from a cleaning perspective, it may warrant evaluating equipment of a different design that can perform the same task. If there are no other alternatives, instructions about how to process the device need to be explored. For example, ultrasonic washers may be needed, or a facility may need to purchase more washers, adding time and cost to the process for a given piece of instru-mentation. The Authority has a sample tool available, providing equipment-pur-chasing guidance in terms of integrating

equipment into the work place. The tool is available with an accompanying Pennsylvania Patient Safety Advisory article at http://patientsafety.pa.gov/pst/Pages/PSAPatientSafetyTopicList.aspx.

The data presented in this article scrapes the surface on a multitude of factors that affect the critical task of reprocess-ing surgical instruments and equipment. Quantitative, qualitative, and expert interview data have been compiled to provide insight into the complexity of a process that affects patient outcomes, patient satisfaction, staff satisfaction, workflow, finance, and other variables. The data and concepts presented herein are intended to give facilities a starting point for self-assessment of the reprocess-ing continuum, inclusive of all users and departments that interact with surgical instruments and equipment, to find quality-improvement opportunities.

ACKNOWLEDGMENTSEdward Finley, BS, data analyst, Pennsylvania Patient Safety Authority, and PHC4 analytic staff contributed to data acquisition for this article.

NOTES

1. Bioburden. [internet]. Farlex Partner Medical Dictionary; 2012 [accessed 2017 Jan 09]. [1 p]. Available: http://medical-dictionary.thefreedictionary.com/bioburden.

2. The American Heritage® Medical Dic-tionary [internet]. Houghton Mifflin Company; 2007, 2004. [accessed 2017 Jan 10]. Biofilm. [1 p]. Available: http://medical-dictionary.thefreedictionary.com/biofilm.

3. Koseki H, Yonekura A, Shida T, Yoda I, Horiuchi H, Morinaga Y, Yanagihara K, Sakoda H, Osaki M, Tomita M. Early staphylococcal biofilm formation on solid orthopaedic implant materials: in vitro study. PLoS ONE. 2014;9(10):e107588. Also available: http://dx.doi.org/10.1371/journal.pone.0107588. PMID: 25299658

4. Centers for Disease Control and Prevention (CDC). Notes from the Field: New Delhi metallo-ß-lactamase-producing Escherichia coli associated with endoscopic retrograde cholangiopancrea-tography - Illinois, 2013. MMWR Morb. Mortal. Wkly. Rep.. 2014 Jan 03;62(51-52):1051. PMID: 24381080

5. Dancer SJ, Stewart M, Coulombe C, Gregori A, Virdi M. Surgical site infec-tions linked to contaminated surgical instruments. J Hosp Infect. 2012 Aug;81(4):231-8. Also available: http://dx.doi.org/10.1016/j.jhin.2012.04.023. PMID: 22704634

6. Goveia VR, Mendoza IY, Guimarães GL, Ercole FF, Couto BR, Leite EM, Stoianoff MA, Ferreira JA. Endotoxins in surgical instruments of hip arthro-plasty. Rev Esc Enferm USP. 2016 May-Jun;50(3):405-10. Also available: http://dx.doi.org/10.1590/S0080-623420160000400005. PMID: 27556710

7. Landgraeber S, von Knoch M, Löer F, Brankamp J, Tsokos M, Grabellus F, Schmid KW, Totsch M. Association between apoptotis and CD4(+)/CD8(+) T-lymphocyte ratio in aseptic loosening after total hip replacement. Int J Biol Sci. 2009;5(2):182-91. PMID: 19214244

8. Nelson JZ. (Supervisor, Special Requests, Pennsylvania Health Care Cost Contain-ment Council (PHC4), Harrisburg, PA). Personal communication. 2016 Oct 7. 4 p.

9. Standards of practice for the decon-tamination of surgical instruments. Littleton (CO): Association of Surgical Technologists (AST); 2009. 27 p. Also available: http://www.ast.org/uploaded-Files/Main_Site/Content/About_Us/Standard_Decontamination_%20Surgi-cal_Instruments_.pdf.


F R O M T H E D A T A B A S E


A Pennsylvania healthcare facility identified a neurological adverse event in a few patients within 8 hours of receiving an intravenous (IV) contrast agent for a radio-logic study. This facility, which used low osmolar, nonionic, monomer, and nonionic iso-osmolar dimer contrast in the studies, contacted the Pennsylvania Patient Safety Authority to inquire whether similar events were reported elsewhere in Pennsylvania. Analysts addressed the request through a focused analysis of radiology contrast events in hospitals of a similar size to the requesting hospital (i.e., hospitals with 300 beds or more).

Contrast media is used as an advanced imaging technique to improve diagnosis, and it is generally safe and effective.1 It is estimated that contrast media is used in mil-lions of radiological studies annually.2 Imaging studies that may require iodinated contrast media include x-ray studies, computed tomography (CT) scans, arteriograms, and interventional radiologic procedures.3 Iodinated contrast media is the most com-monly used IV contrast agent.4 An estimated 2% to 17% of patients receiving contrast media experience an adverse effect, regardless of the contrast type.4,5 Adverse reactions mostly occur with IV administration; however, they also occur with intra-arterial and nonvascular injections.3 Knowledge of adverse reactions, prevention, preparation, and adequate response when a reaction occurs are essential to providing safe care to patients undergoing imaging studies with contrast agents.2

METHODS

In response to the request, Authority analysts queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) to identify radiology contrast–related events in hospitals with 300 beds or more over a 2-year period, from January 2014 through December 2015. The following search terms and word roots were used to identify applicable events: procedu, omni, visip, power inject, contrast, mri, and mra. The query identi-fied more than 4,600 event reports. Analysts reviewed individual free text fields, such as the event narratives, using key terms including the following: MRI, contrast, power injection, study, procedure, infiltration, extravasation, allergic reactions, adverse events, Omnipaque®, and Visipaque™. Of the 4,609 events, 544 were excluded because they had no relevance to contrast administration (e.g., contrast was not given, or was men-tioned incidentally). The remaining 4,065 event reports addressed IV, oral, and enteral routes of contrast administration.

Analysts conducted an extensive review of the literature and an Internet search to obtain epidemiological data on the use of radiologic contrast media, adverse reac-tions, and treatments. A medical librarian assisted with a search for published articles indexed through July 31, 2016, in AccessMedicine, EBSCO Biomedical Reference, Embase, Google, Google Scholar, PubMed, Cochrane, Scopus, and UpToDate data-bases and search engines. Searches included terms such as radiocontrast agents, media, contaminate, neurological, microemboli, and stroke.

RESULTS

Harm and patient age. The majority of the event reports were Incidents (i.e., near miss event or events that reached the patient but did not result in harm or require additional interventions): 99.2% (n = 4,034 of 4,065). The remaining 0.8% (n = 31) events were Serious Events, in which an event reached the patient and resulted in harm—including severe extravasations, nephrotoxicity, and cardiac events—and required additional intervention.

Radiology Contrast Concerns: Reports of Extravasation and Allergic Reactions

Lea Anne Gardner, PhD, RN Senior Patient Safety Analyst

Pennsylvania Patient Safety AuthorityKelly Scott, BSN, RN

Oncology Breast Healthcare Nurse Navigator Penn Medicine

Mary C. Magee, MSN, RN, CPHQ, CPPS Senior Patient Safety Analyst


Corresponding AuthorMary C. Magee


Patients in the age group 50 to 59 years had the largest number of reported events (19.8%, n = 805) and patients 60 years or older accounted for 46.5% (n = 1,889) of reported events; these findings parallel findings in the study by Ha, Kim, and Sohn.6 Patients in the age group newborn to 18 years had the fewest number of events reported (2.1%, n = 87).

Radiology contrast route. Administration of IV radiology contrast was noted in 89.9% (n = 3,653 of 4,065) event reports. Oral or enteral routes were noted in 2.8% (n = 112) of the event reports, and the remaining events lacked a description of the route of contrast administration (7.4%; n = 300).

Adverse effect conditions. Not all patients experienced an adverse event and not all conditions caused or explained the adverse event. Almost two-thirds of the event reports (63.4%; n = 2,577 of 4,065) were related to IV contrast infiltrations or extravasations. Another 22.1% (n = 897) were related to allergic reactions. Analysts identified eight types of adverse effects associated with contrast media–related event reports (see Figure). Although less frequently reported, complications of oral contrast included vomiting (n = 8), with the potential for aspiration.

The most frequently reported body system affected was the integumentary system, due to the infiltrations and extravasations as noted above, followed by the renal sys-tem at 1.3% (n = 51 of 4,065). There were no reports of neurological adverse effect conditions in this period.

DISCUSSION

Adverse reactions. Acute reactions to contrast media, including allergic and allergic-like reactions, can be divided into three categories: mild, moderate, and severe.1,5,6 Mild symptoms typically include erythema, nausea, vomiting, pruritus, headache, and mild urticaria.4-6 Patients who experience mild reactions require

little intervention beyond routine patient care and monitoring and will typically recover in a few hours. Patients with mod-erate reactions may have any or all of the mild symptoms and additionally might exhibit bronchospasm, moderate urti-caria, chest pain, dyspnea, hypotension or hypertension, tachycardia or bradycardia, and other vasovagal responses. Patients with moderate reactions may require therapeutic intervention and monitor-ing, but most do not require admission. Severe reactions occured in fewer than 1% of patients who received contrast and happen quickly after administration of contrast, usually within 20 to 30 min-utes.4 Immediate intervention is required because severe reactions can be life- threatening. Severe reactions may include laryngeal edema, severe bronchospasm, seizure, convulsion, unresponsiveness, and death.4-6 Delayed reactions, those

appearing more than 30 minutes or within 7 days of receiving contrast, occur in 8% to 30% of patients, and the percentage depends on the molecular structure of the iodinated contrast given (e.g., ionic versus non-ionic monomers).5 Delayed reactions include rash, urticaria, flu-like symptoms, and polyarthropathy.1,5

Treating patients who have known con-trast allergies or patients at risk for an allergic reaction, such as those with prior sensitivity to contrast, includes preventa-tive interventions such as administering corticosteriods.2,5

An extensive literature search specifically addressing neurological adverse reactions was performed to address the initial inquiry into this topic. This search identi-fied no studies directly linking radiologic contrast media alone to neurological adverse reactions. Neurologic complica-tions, such as stroke and myocardial

Figure. Radiology Contrast Adverse Events (N = 4,065)

IV infiltrations/extravasations

n = 2,577

Miscellaneous(e.g., non-IV extravasation,medication errors)n = 184

Equipmentfailuresn = 53

Renal effectsn = 51

Wrong patient,procedure,route, or siten = 52

Adversereactionsn = 165

MS17

276

Order-relatedimplicationsn = 129

Allergicreactionsn = 897

Notes: As reported through the Pennsylvania Patient Safety Reporting System, January 2014 through December 2015. Total equals 4,108 because reporters could indicate more than one adverse condition.


F R O M T H E D A T A B A S E


infarction, can be associated with air embolism, and “clinically significant air emboli are potentially fatal”; they are most commonly associated with the use of power injectors.2,4

The literature search returned two older studies linking particulate matter with the risk of emboli formation and the pos-sibility of cardiac and neurologic adverse events.7,8 Winding studied angiographic contrast media in ampules and vials. Particles were found in all brands tested and the author recommended “contrast media be passed through a filter during administration.”7

Hirakawa and coauthors studied radio-graphic contrast media administered intravenously through an automatic injector and noted that “particulate con-tamination of the radiographic contrast media occurs as a result of the interaction with silicone and sulfur on the surface of the disposable syringe components. High speed injection increases the risk of contrast media contamination from the particulate matter after transfer from the vial to a disposable syringe.”8 A sampling of two package inserts for radiographic contrast media includes a standard rec-ommendation to “visually inspect the product for discoloration and particulate matter prior to administration.”9,10

Extravasation. These events occur when vascular access is compromised and the contrast media enters the surrounding tissue. Contrast media is toxic to sur-rounding tissues, especially skin, with a local inflammatory response that can peak in 24 to 48 hours.2 Pain (e.g., burn-ing or stinging) or swelling or tightness are the main patient complaints when extravasation occurs; however, some patients experience little or no discom-fort.2 Physical examination may uncover a site that is edematous, erythematous, and tender in mild cases and painful or blister-ing in moderate cases.2,4 Treatment for a

contrast-media extravasation is aimed at the clinical manifestations present and may include elevation of the affected extremity above the heart to promote reabsorption, application of either warm or cold compresses, and monitoring of the limb for several hours.2,4 Compartment syndrome is a severe injury that is more likely to occur after extravasation of larger volumes of contrast media.2 Physical assessment may uncover progressive swell-ing, increasing or severe pain, change in sensation, and decreased circulation.2,4 Medical follow up is recommended and surgical consultation may be warranted.2,4 The American College of Radiologists recommends “close clinical follow up for several hours for all patients experiencing an extravasation.”2

Risk factors. The following risk factors can predispose a patient to an adverse event: previous severe reaction to a con-trast agent, history of multiple allergies, asthma, dehydration, diabetes, renal disease, sickle cell anemia, polycythemia, myeloma, cardiac disease, thyroid disease (e.g., hyperthyroidism, carcinoma), anxi-ety, age older than 60 years, concomitant use of certain intra-arterial injections such

as papaverine, and certain medications such as beta blockers and metformin.2,5,6

As noted in the PA-PSRS data, patients age 60 years or older accounted for 46.5% of the event reports. Incidentally, the administration of metformin was reported in 26 of the event reports. Staff education on all risk factors including screening for patient age may help reduce the risk of an adverse event or reaction. Likewise, edu-cation on the importance of timing the administration of metformin relative to the administration of radiologic contrast media may help reduce likelihood of a delay in obtaining the contrast study and the risk of nephrology complications.

For a list of evidence-based resources on the safe use of radiologic contrast media, see “Safe Use of Radiologic Contrast Media.”

CONCLUSION

Although the administration of radiologic contrast media is generally safe, it is not without risks. As seen in the PA-PSRS data and literature, most adverse events are mild and do not result in permanent patient harm. Knowledge, prevention,

SAFE USE OF RADIOLOGIC CONTRAST MEDIA

Here are evidence-based resources outlining the safe use of radiologic contrast media, including risk factors, reactions, adverse effects, and treatment.

ACR Committee on Drugs and Contrast Media. ACR manual on contrast media. Ver-sion 10.2. Reston (VA): American College of Radiology; 2016. 124 p. Also available: https://www.acr.org/Quality-Safety/Resources/Contrast-Manual.

Beckett KR, Moriarity AK, Langer JM. Safe use of contrast media: what the radiolo-gist needs to know. Radiographics. 2015 Oct;35(6):1738-50. Also available: http://dx.doi.org/10.1148/rg.2015150033. PMID: 26466182.

Matthews EP. Adverse effects of iodine-derived intravenous radiopaque con-trast media. Radiol Technol. 2015 Jul-Aug;86(6):623-38; quiz 639-42. PMID: 26199435.


recognition, and prompt management of adverse reactions to radiologic contrast media can all contribute to providing safe care to patients undergoing contrast-related studies. Additionally, knowing the types and severity of radiology contrast

events that occur in a facility can guide staff in proactive prevention and screen-ing strategies and in implementing the appropriate responsive actions to mitigate patient harm.

ACKNOWLEDGEMENTSTimothy Horine, RN BSN, Staff Nurse, Neuro Cardiac ICU, Bryn Mawr Hospital, contributed to the data analysis for this article.

NOTES

1. Beckett KR, Moriarity AK, Langer JM. Safe use of contrast media: what the radiologist needs to know. Radiograph-ics. 2015 Oct;35(6):1738-50. Also available: http://dx.doi.org/10.1148/rg.2015150033. PMID: 26466182.

2. ACR Committee on Drugs and Contrast Media. ACR manual on contrast media. Version 10.2. Reston (VA): American College of Radiology; 2016. 124 p. Also available: https://www.acr.org/Quality-Safety/Resources/Contrast-Manual.

3. Hong SJ, Cochran ST. Immediate hyper-sensitivity reactions to radiocontrast media: Clinical manifestations, diagnosis, and treatment. In: UpToDate [internet]. Alphen aan den Rijn (The Netherlands): Wolters Kluwer; 2015 Oct 16 [accessed 2016 Oct 28]. Available: http://www.uptodate.com.

4. Matthews EP. Adverse effects of iodine-derived intravenous radiopaque contrast media. Radiol Technol. 2015 Jul-Aug;86(6):623-38; quiz 639-42. PMID: 26199435.

5. Siddiqi NH. Contrast medium reactions. In: Medscape Reference [internet]. New York (NY): WebMD, LLC; 2016 Jun 2 [accessed 2016 Oct 28]. [13 p]. Avail-able: http://emedicine.medscape.com/article/422855-overview.

6. Ha SO, Kim DY, Sohn YD. Clinical characteristics of adverse reactions to nonionic low osmolality contrast media in patients transferred from the CT room to the emergency room. Springerplus. 2016;5(1):929. Also available: http://dx.doi.org/10.1186/s40064-016-2380-5. PMID: 27386373.

7. Winding O. Intrinsic particles in angiographic contrast media. Radiology. 1980 Feb;134(2):317-20. Also available: http://dx.doi.org/10.1148/radiology. 134.2.7352208. PMID: 7352208.

8. Hirakawa M, Sendo T, Kataoka Y, Oishi R. High speed injection of radiographic contrast media induces severe particu-late contamination. Br J Radiol. 1999 Oct;72(862):998-9. Also available: http://dx.doi.org/10.1259/bjr.72.862.10673952. PMID: 10673952.

9. GE Healthcare Inc. Omnipaque (iohexol) Injection. Prescribing information. Princ-eton (NJ): GE Healthcare Inc.; 2010 May. 8 p.10.

10. GE Healthcare Inc. Visipaque (iodixanol) Injection. Bulk pack prescribing informa-tion. Princeton (NJ): GE Healthcare Inc.; 2008 May. 6 p.


O T H E R F E A T U R E S


To improve the safety and quality of healthcare, we try to understand and improve how healthcare providers accomplish patient care “work.” This work includes synthesizing information from a patient’s history and physical examination or from a handoff; per-forming tests or procedures; administering medications; and providing information so that patients can make the best choices for themselves. Sometimes this work flows very well and everyone is pleased with the results. Sometimes this work does not unfold in the way that was anticipated. Perhaps the patient’s condition is more complicated than usual, or perhaps a needed resource—a medication, a piece of equipment, available operating room time, or a consultant—is not readily available. Perhaps there is time pressure, or we encounter distractions and interruptions. Healthcare providers often complete tasks that are necessary for patient care despite obstacles in their path, and without necessarily reporting, let alone fixing, those obstacles.

Efforts to improve healthcare work will not succeed without recognizing that there is a difference between a theoretical construct of “work-as-imagined” and the reality of “work-as-done” (see Figure). Work-as-imagined is the illusory ideal state. Hollnagel describes work-as-imagined as what designers, managers, regulators, and authorities believe happens or should happen, which becomes the basis for design, training, and control. In contrast, work-as-done is what truly occurs and what people actually do dur-ing patient care.1

Although a complete and perfect understanding of work-as-done is a worthy goal, healthcare delivery is a complex adaptive system that is in constant evolution with fluid, dynamic changes.2-6 Complete understanding is an unattainable ideal. Work-as-imagined provides information based on conceptual processes; it can offer a valuable hypothetical construct of the work in question, and may be used to develop theoretical concepts and generalizable guidance. Work-as-imagined may not reflect actual condi-tions that impact patient care at the “sharp end,” the point in patient care that directly impacts patients. However, exploring the gap between work-as-imagined and work-as-done does afford opportunities to look at work through a variety of lenses, each of which provides complementary information. Each lens has attributes and limitations; a preliminary exploration of several potential lenses, such as “work-as-documented” and “work-as-observed,” follows.

With the blossoming of computer science, discrete event simulation can be used to analyze patient flow, predict demands for services, and mathematically model the impact of interventions on patient care processes. Standardized parameters for process components can be manipulated to calculate the effect of increasing patient volume or restructuring patient flow processes (e.g., change the triage process, add an ultrasound machine). Discrete event simulation can facilitate analysis of nonlinear interactions between variables and their intermediary agents; this could be considered “work-as-abstracted.”7

“Work-as-observed” occurs when care providers know they are being watched, whether informally by trainees or colleagues during patient care, or formally, such as dur-ing evaluations (e.g., certification examinations) or as participants in research. The well-known Hawthorne effect posits that participants modify their actions when they know they are being observed.8 As a consequence, the work that occurs during, for example, executive walkrounds, may not fully represent the work that occurs in normal situations.

Documentation, fundamentally linked to patient care activities, serves many masters. Documentation is used to communicate meaningful patient care information, support

Bridging the Gap between Work-as-Imagined and Work-as-Done

Ellen S Deutsch, MD, MS, FACS, FAAP, CPPS Editor, Pennsylvania Patient Safety Advisory

Medical Director, Pennsylvania Patient Safety Authority


billing, and provide medicolegal informa-tion. The accuracy and completeness of “work-as-documented” may be impacted by the skills and memory of the person documenting, the ease or challenge of the documentation process, and the temporal distance between the patient care event

and the opportunity to document. When a scribe is added to the documentation process, opportunities for incomplete understanding and miscommunication may arise. Understanding work-as-done by using administrative databases, chart

audits, and trigger tools9-12 relies on work-as-documented.

Claims are written demands for com-pensation for medical injury, which may be submitted by patients and their families because they have been advised

Figure. Facets of the Work Process




to sue; because they perceive physician dishonesty; because they seek informa-tion, resources for future medical costs, or revenge; or for other reasons.13,14 “Work-as-claimed” is a lagging indicator, often reflecting occurrences that are several years old.13,15 The relationship between medical malpractice events and medical malpractice claims is complicated and nonlinear.14 Some claims are without merit, whereas the majority of patients who sustain a medical injury as a result of negligence do not sue.13

Simulation uses manikins or other equip-ment to replicate patient care experiences, allowing healthcare workers to practice their skills without direct risk to patients.16 Simulations conducted in situ, in actual

patient care settings, provide a way to study and improve patient care processes while concurrently enhancing both team and individual patient care skills.17 A lim-itless variety of patient care processes can be simulated. Simulations may range from simple tasks such as transporting a patient into a new patient care area or conduct-ing a handoff, to complex tasks such as preparing to implement a new electronic health record module, implementing and maintaining a patient on extracorporeal membrane oxygenation (ECMO), activat-ing a protocol for massive transfusion, or conducting a disaster drill.18-21 “Work-as-simulated,” including skilled debriefing, may come the closest to replicating work-as-done, particularly for uncommon events.22

Because healthcare delivery is a complex adaptive system, understanding work-as-done is a daunting task, and no single perspective will provide the whole truth. In an extensive review of the advantages and limitations of different methods used to monitor patient safety, Sun asserts, “. . . different methods for detecting patient safety problems overlap very little in the safety problems they detect. These meth-ods complement each other and should be used in combination to provide a comprehensive safety picture of the health care organization.”23 Recognizing the attributes and limitations of each patient safety lens can help facilities develop a more comprehensive and realistic under-standing of work-as-done, which can then inform efforts to improve patient safety.

NOTES

1. Hollnagel E. Prologue: Why do our expec-tations of how work should be done never correspond exactly to how work is done? In: Braithwaite J, Wears RL, Hollnagel E, editors. Resilient Health Care. Vol. 3. Reconciling work-as-imagined and work-as-done. Boca Raton (FL): CRC Press, Taylor & Francis Group; 2017. p. xvii-xxv.

2. Vincent C. Patient safety. 2nd ed. Boca Raton (FL): CRC Press; 2010. 432 p.

3. Dekker S. Drift into failure: from hunting broken components to understanding complex systems. Farnham (UK): Ashgate Publishing, Ltd.; 2012.

4. Deutsch ES. More than complicated, healthcare delivery is complex, adaptive, and evolving. Pa Patient Saf Advis. 2016 Mar;13(1):39-40. http://patientsafety.pa.gov/ADVISORIES/Pages/201603_ 39.aspx.

5. Gell-Mann M. Complex adaptive systems. In: Cowan G, Pines D, Meltzer D, editors. Complexity: metaphors, models, and real-ity. Boston (MA): Addison-Wesley; 1994. p. 17-45.

6. Plsek PE, Greenhalgh T. Complexity science: the challenge of complex-ity in health care. BMJ. 2001 Sep 15;323(7313):625-8. PMID: 11557716. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1121189/.

7. Day TE, Al-Roubaie AR, Goldlust EJ. Decreased length of stay after addition of healthcare provider in emergency department triage: a com-parison between computer-simulated and real-world interventions. Emerg Med J. 2013 Feb;30(2):134-8. Also available: http://dx.doi.org/10.1136/emermed-2012-201113. PMID: 22398851.

8. Sedgwick P, Greenwood N. Understand-ing the Hawthorne effect. BMJ. 2015 Sep 04;351:h4672. PMID: 26341898. http://www.bmj.com/content/351/bmj.h4672.long.

9. Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, Whittington JC, Frankel A, Seger A, James BC. ‘Global trigger tool’ shows that adverse events in hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011 Apr;30(4):581-9. PMID: 21471476.

10. Mattsson TO, Knudsen JL, Lauritsen J, Brixen K, Herrstedt J. Assessment of the global trigger tool to measure, moni-tor and evaluate patient safety in cancer patients: reliability concerns are raised. BMJ Qual Saf. 2013 Jul;22(7):571-9. Also available: http://dx.doi.org/10.1136/bmjqs-2012-001219. PMID: 23447657.

11. Murphy DR, Meyer AN, Bhise V, Russo E, Sittig DF, Wei L, Wu L, Singh H. Computerized triggers of big data to detect delays in follow-up of chest imaging results. Chest. 2016 Sep;150(3):613-20. Also available: https://dx.doi.org/10.1016/j.chest.2016.05.001.

12. Westbrook JI, Li L, Lehnbom EC, Baysari MT, Braithwaite J, Burke R, Conn C, Day RO. What are incident reports telling us? A comparative study at two Australian hospitals of medication errors identified at audit, detected by staff and reported to an incident system. Int J Qual Health Care. 2015 Feb;27(1):1-9. Also available: http://dx.doi.org/10.1093/intqhc/mzu098. PMID: 25583702.

13. Studdert DM, Mello MM, Gawande AA, Gandhi TK, Kachalia A, Yoon C, Puopolo AL, Brennan TA. Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med. 2006 May 11;354(19):2024-33. Also available: http://dx.doi.org/10.1056/NEJMsa054479. PMID: 16687715.

14. Rothstein MA. Currents in contemporary bioethics. Health care reform and medi-cal malpractice claims. J Law Med Ethics. 2010 Winter;38(4):871-4. Also available: http://dx.doi.org/10.1111/j.1748-720X.2010.00540.x. PMID: 21105950.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1121189/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1121189/

http://dx.doi.org/10.1136/emermed-2012-201113

http://dx.doi.org/10.1136/emermed-2012-201113

http://www.bmj.com/content/351/bmj.h4672.long



http://dx.doi.org/10.1136/bmjqs-2012-001219


https://dx.doi.org/10.1016/j.chest.2016.05.001

https://dx.doi.org/10.1016/j.chest.2016.05.001

http://dx.doi.org/10.1093/intqhc/mzu098

http://dx.doi.org/10.1093/intqhc/mzu098

http://dx.doi.org/10.1056/NEJMsa054479

http://dx.doi.org/10.1056/NEJMsa054479

http://dx.doi.org/10.1111/j.1748-720X.2010.00540.x

http://dx.doi.org/10.1111/j.1748-720X.2010.00540.x


15. Kreidler M. 2016 Medical malpractice annual report. Olympia (WA): Wash-ington State Office of the Insurance Commissioner; 2016 Sep 1. 86 p. Also available: https://www.insurance.wa.gov/about-oic/reports/commissioner-reports/documents/2016-med-mal-annual- report.pdf.

16. Deutsch ES. Simulation in oto-laryngology: smart dummies and more. Otolaryngol Head Neck Surg. 2011 Dec;145(6):899-903. Also available: http://dx.doi.org/10.1177/0194599811424862. PMID: 21965444.

17. Lockman JL, Ambardekar A, Deutsch ES. Chapter 2.2. Optimizing education with in situ simulation. In: Palaganas JC, Maxworthy JC, Epps CA, Mancini ME, editors. Defining excellence in simulation programs. Philadelphia (PA): Wolters Kluwer; 2015. p. 90-8.

18. Geis GL, Pio B, Pendergrass TL, Moyer MR, Patterson MD. Simulation to assess the safety of new healthcare teams and new facilities. Simul Healthc. 2011 Jun;6(3):125-33. Also avail-able: http://dx.doi.org/10.1097/SIH.0b013e31820dff30. PMID: 21383646.

19. Patterson MD, Blike GT, Nadkarni VM. In situ simulation: challenges and results. In: Henriksen K, Battles JB, Keyes MA, Grady ML, editors. Advances in patient safety: new directions and alternative approaches. Vol. 3. Performance and tools. Rockville (MD): Agency for Health-care Research and Quality (AHRQ); 2008.

20. Patterson MD, Geis GL, LeMaster T, Wears RL. Impact of multidisciplinary simulation-based training on patient safety in a paediatric emergency department. BMJ Qual Saf. 2013 May;22(5):383-93. Also available: http://dx.doi.org/10.1136/bmjqs-2012-000951. PMID: 23258388.

21. Weintraub AY, Deutsch ES, Hales RL, Buchanan NA, Rock WL, Rehman MA. Using high-technology simulators to prepare anesthesia providers before imple-mentation of a new electronic health record module: a technical report. Anesth Analg. 2017 Jun;124(6):1815-9. PMID: 28207594.

22. Patterson M, Deutsch ES, Jacobson L. Chapter 13: Closing the gap between work-as-imagined and work-as-done. In: Braithwaite J, Wears RL, Hollnagel E, editors. Resilient health care. Vol. 3.

Reconciling work-as-imagined and work-as-done. Boca Raton (FL): CRC Press, Taylor & Francis Group; 2017. p. 143-52.

23. Sun F. Chapter 36: Monitoring patient safety problems. In: Shekelle PG, Wachter RM, Pronovost PJ, Schoelles K, McDon-ald KM, Dy SM, Shojania K, Reston J, Berger Z, Johnsen B, Larkin JW, Lucas S, Martinez K, Motala A, Newberry SJ, Noble M, Pfoh E, Ranji SR, Rennke S, Schmidt E, Shanman R, Sullivan N, Sun F, Tipton K, Treadwell JR, Tsou A, Vaiana ME, Weaver SJ, Wilson R, Winters BD. Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Evidence report/technology assessment no. 211, Agency for Healthcare Research and Quality. Evid Rep Technol Assess (Full Rep). 2013 Mar;(211):1-945. Also available: https://www.ncbi.nlm.nih.gov/books/NBK133411/#ch36.s9

https://www.insurance.wa.gov/about-oic/reports/commissioner-reports/documents/2016-med-mal-annual-report.pdf




http://dx.doi.org/10.1177/0194599811424862

http://dx.doi.org/10.1177/0194599811424862

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http://dx.doi.org/10.1097/SIH.0b013e31820dff30



https://www.ncbi.nlm.nih.gov/books/NBK133411/#ch36.s9

https://www.ncbi.nlm.nih.gov/books/NBK133411/#ch36.s9




SAVES, SYSTEM IMPROVEMENTS, AND SAFETY-II

“Saves, System Improvements, and Safety-II” is an occasional feature in the Pennsylvania Patient Safety Advisory, highlighting successes of healthcare workers in keeping patients safe. The Safety-II approach assumes that everyday performance variability provides adaptations needed to respond to varying condi-tions and that humans are a resource for system flexibility and resilience.

An Unexpected Problem: Was the Response Correct?

The following event report was submitted through the Pennsylva-nia Patient Safety Reporting System (PA-PSRS):*

A patient arrived for a routine after-hours radiologic study and expressed that she was not feeling well. As the study began, she indicated that she was having trouble breathing. The technician noted a decreasing oxygen saturation, and the patient described increased difficulty breathing. The techni-cian placed the patient on oxygen according to the organiza-tion’s [emergency response] policies and called 911. The technician monitored the patient until the ambulance crew arrived and took responsibility, and the patient was trans-ported to an acute care facility.

The facility praised the technician for acting promptly and correctly.

Healthcare providers sometimes encounter situations in which they respond to a patient’s unexpected deterioration but are unsure whether their actions were too aggressive. This technician may have wondered whether his or her actions on the patient’s behalf were medically correct and, further, whether those actions might prompt a reprimand for disrupting a scheduled study. This report provides an important example of reinforcing cor-rect actions. Learning from failures and errors is important, but successes also provide learning opportunities. Learning from success is particularly important when learners are unsure whether the success is a result of their abilities and efforts or occurred as a lucky outcome; such learning is important when the cost of errors is high.1 The Pennsylvania Patient Safety Authority applauds this facility for supporting the technician and for sharing their actions through PA-PSRS.

Note1. Ellis S, Davidi I. After-event reviews: drawing lessons from success-

ful and failed experience. J Appl Psychol. 2005 Sep;90(5):857-71. Also available: http://dx.doi.org/10.1037/0021-9010.90.5.857. PMID: 16162059.

* The details of the PA-PSRS event narrative in this article have been modified to preserve confidentiality.

http://dx.doi.org/10.1037/0021-9010.90.5.857

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The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (MCARE) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s website at http://patientsafety.pa.gov.

ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 50 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures, and drug technology.

The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community, including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.

THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS

PENNSYLVANIAPATIENT SAFET Y ADVISORY