Preventing Medical ErrorsVincent Hsu, MD, MPHHospital Epidemiologist

Assistant Director, Internal Medicine ResidencyFlorida Hospital

Florida Medical AssociationAug 4, 2017

2016-17Disclosures: none

2016: Another Study on Impact of Med Errors

Almost 20 Years After IOM

• 1999: To Err is Human• 44 to 98K deaths• SYSTEM fix

• Spurred first wave of changes in healthcare

• Science of patient safety is still evolving

Preventable Events In Hospitals• Office of Inspector General, reviewed 780 Medicare charts

• 27% experienced harm• 13.5% adverse events• 1.5% contributed to deaths (180K /year)• 44% of all harm events were preventable

https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf

James JT. J Patient Saf 2013;9: 122-128

Estimates of Errors Vary Wildly: Does it Matter?• NYT: Death by Medical Error:

Adding Context to Scary Headlines

• Contribute vs cause• Preventability• Complexity • Numbers should not detract

from the work that must be done

New York Times, August 2016 http://www.nytimes.com/2016/08/16/upshot/death-by-medical-error-adding-context-to-some-scary-numbers.html

Medical Errors Defined• Types of ME

• Diagnostic• Treatment• Prevention• Communication• Medication

• Adverse event: any injury from medical intervention

• Errors of comission vs omission• Not always well defined…

What Do Patients Think? Using Social Media• Of 1006 tweets, 99% were from patients or their family member

• 52% blamed physician, 16% hospital• Most common procedural (26%), medication (23%), diagnostic (23%),

surgical (14%)• Examples

• “…Hubby went in for what should have been a straight forward procedure. Surgeon screwed up and Brian died in my arms in February”

• “Nurse gave me the wrong shot!! OMG what if I died or what if something bad happened I mean I’m already sick #scared”

• “Just wanted to tell you all that I am going to be ok. The doctor made a mistake. I do not have cancer. Thank God!”

• “Love getting a letter that says my doctor messed up my leg by my lawyer and that we go to court in less than two months.”

Nakhasi A. et al. The potential of Twitter as a data source for patient safety. J Patient Saf 2016

No Signifcant Change in Harm Over 7 Year Period

Landrigan et al. N Engl J Med 2010; 363:2124-2134

Florida is Making Gains: 2015 FHA Quality Report

Florida Hospital Association http://fha.informz.net/FHA/data/images/FHA/2015QualityReport.pdf

Medical Errors in the Ambulatory Setting

• Less than 10% of studies• Ambulatory malpractice claims

account for almost half compared to acute care (30:1 OP to acute care visits), but

• Proportion ambulatory: acute care increasing

• Diagnostic as opposed to surgical• Lack of follow up of lab / radiology

resultsBishop TF JAMA 2011;305(23):2427-2431 doi:10.1001/jama.2011.813Smith PC. JAMA 2005;293:565-571

Disclosure of Medical Error

• Dr Yeung, a dermatologist, had just completed skin biopsy procedures on 2 patients and when he went to get an instrument tray for a third procedure, he realized that none of the instruments he used had been sterilized. He spoke to the clinic staff and looked at the sterilization test strips for all the trays and confirmed that none of the trays were sterile.

• Dr Yeung realizes that the risk of infection from the unsterilized equipment is very low, but blood-borne infections such as hepatitis and HIV could be transmitted. His dilemma is whether to tell the patients about the error and, if so, what to say.

Levinson W. JAMA. 2016;316(7):764-765. doi:10.1001/jama.2016.9136.

What Would You Do Next?

1. Do nothing; the risk for infection is low and telling the patients about the potential problems will cause undue anxiety.

2. Tell the patients there was an “adverse event” and offer a statement of regret.

3. Report it to the department that does root cause analysis of errors so future errors might be prevented.

4. Tell the patients the details of the mistake and apologize. Tell the patients that the hospital will investigate how it happened and that you will inform them of the outcome.

Levinson W. JAMA. 2016;316(7):764-765. doi:10.1001/jama.2016.9136.

Bottom Line• When errors occur, the patient should be

told about the error and an apology provided. Information about errors should never be withheld from patients.

• All personnel involved should participate in the review of the error and in solving any systems problems that contributed to the occurrence of the error.

• Contact the institution’s quality assurance department, risk management group, and/or malpractice carrier to inform them of the error.

How Medical Errors are Reported in the Hospital Setting

Physician:- Incident report to Risk Management- Consult with patient safety program

Institution: - Patient grievance- Global trigger tool

Code 15

Sentinel Event

Five Most Misdiagnosed Conditions, 20171. Cancer2. Neurologic / spine3. Cardiac / stroke4. Infectious / communicable (2016)5. Pulmonary (2016)

Rule 64B8-13.005, effective 2/29/16. https://www.flrules.org/gateway/notice_Files.asp?ID=17162227. Last accessed 8/1/2017

Diagnostic Errors: System & Provider-Related

• Diagnostic errors constituted 29% of malpractice errors –“failure to diagnose”

BMJ Qual Saf 2013; Online First 22 Apr 2013

doi:10.1136

1: Failure to Diagnose Breast Cancer• 2nd leading cause of female cancer deaths • 213,000 women diagnosed annually• 41,000 deaths annually• 1 in 8 chance of developing breast CA in

woman’s lifetime• Misdiagnosis of breast CA most prevalent reason

for physician malpractice lawsuits• 41% breast CA-related claims decided in

plaintiff’s favor (vs 29% all claims)

398 Initial Mammogram Findings

Of patients ultimately diagnosed with breast CA, 53% had an initial negative mammogramPIAA Breast Cancer Study, 1995-2002

450 Claimants Percentage by Age

74% of misdiagnoses involved pre- and peri-menopausal patients

PIAA Breast Cancer Study, 1995-2002

Most Common Physician Issues in Malpractice

PIAA Breast Cancer Study, 1995-2002

PIAA Breast Cancer Study, 2015

• Radiologists most common specialty for claims –mammography, followed by OB/GYN, IM, general surgery

• Diagnostic errors most common, followed by failure to supervise, delay in performance

• In 59% of claims, patients presented with something other than breast cancer as initial reason for medical visit

https://www.johnsonlambert.com/news-blog/2014/02/07/new-study-elucidates-impact-breast-cancer-diagnosis-and-treatment-medical

Lessons Learned

• Any woman of any age can have breast cancer• Any woman of any age must be fully screened

• Mammography• If necessary, ultrasound and biopsy• Correlate clinical and radiologic findings

• Do not depend on a negative mammogram alone if doubts or concerns by provider or patient

2. Neurological / Spine related issues

• Potential for irreversible neurologic damage• Neurologic emergencies

• Stroke: ischemic, hemorrhagic• Subarachnoid hemorrhage• Spinal cord injury• Status epilepticus

• Failure to perform an adequate neurologic examination

Red Flags for Acute Low Back Pain

HISTORY• Cancer• Unexplained weight loss• Immunosuppression• Prolonged steroid use• Intravenous drug use• Urinary tract infection• Pain increased or unrelieved by rest• Significant trauma related to age• Bladder or bowel incontinence• Urinary retention

PHYSICAL EXAM• Saddle anesthesia• Loss of anal sphincter tone• Major motor weakness in lower

extremities• Fever• Vertebral tenderness• Limited spinal range of motion• Neurologic findings persisting

beyond one month

3. Cardiac and Stroke-related Issues

• August 2000: 50y/o Filipino male presents to ED with nausea, HA, dizziness, double vision

• He was sent home with painkillers, diagnosed with sinusitis by unlicensed PA without an adequate history or neuro exam

• Returned to ED next day; diagnosed with CVA and had surgery to relieve cerebral edema

• In a coma for 3 months & permanently disabled• Case went to trial and plaintiff was awarded $217 million jury

award, largest in FL history

Stroke Misdiagnosis

• 3rd leading cause of death in U.S.• Risk factors similar to that of

heart disease• Factors involved in misdiagnosis

• Timeliness• Failure to do thorough H&P• Misreading of MRI / CT• Not giving TPA when indicated

(within 3 to 4.5 hours of symptom onset)

Cardiac Misdiagnosis

• Heart disease leading cause of death in the U.S. with about 700,000 deaths annually (29% of all deaths)

• PIAA Acute MI Study • Claims: 3rd most expensive

and 4th most prevalent• Most common root cause:

diagnostic error, especially ECG misinterpretation

4. Infection and Communicable Diseases

1. Recognize sepsis2. Prescribe antibiotics wisely3. Break transmission of communicable disease

The Impact of – and Difficulty in Recognizing – Sepsis• 150K deaths annually based on death certificates, but higher

based on admin claims• Present in ~10% of inpatients on admission, but contributes to

up to half of all hospital deaths in US• Requires critical thinking – no confirmatory lab marker• Sepsis may be “overdiagnosed” through administrative data as

a wastebasket term for anyone with inflammatory response• Early sepsis or even overt sepsis may present similarly to other

systemic conditions

CDC. MMWR 2016; 65(13): 342-45Liu V et al. JAMA 2014;312(1):90-92 doi:10.1001/jama.2014.580

Sepsis: Old Definitions Had Issues• 2001 SIRS (markers of inflammation) was oversensitive, not

specific• T>38, <36• HR >90• RR >20 or PaCO2 <32mm Hg• WBC >12K, <4K

• Almost half of hospitalized patients had SIRS, or an inflammatory response; think about your sepsis alert

• Severe sepsis, what we typically think of sepsis• Septic shock

Am J respir Crit Care Med 2015; 192:958-964

3rd International Consensus Definition (February 2016)• Re-appraised latest understanding:

life-threatening organ dysfunction caused by dysregulated host response to infection

• Removed severe sepsis• Septic shock is “really, really, really

bad” sepsis, i.e. high mortality (requires vasopressors MAP ≥65 mmHg and lactate >2 mmol/L, mortality >40%)

• Better but not perfect JAMA 2016; 315:801-10

SOFA, and qSOFA• Objective measurements of organ dysfunction

• Sequential organ failure assessment• best in ICU• ≥2 SOFA• Mortality ~10%

• qSOFA• RR ≥22• Altered mentation• Systolic BP <100• Best in ED/ wards

Sepsis Redefinition using SOFAPaO2/FiO2 (mmHg) SOFA score Bilirubin (mg/dl) [μmol/L] SOFA score

< 400 1 1.2–1.9 [> 20-32] 1< 300 2 2.0–5.9 [33-101] 2< 200 and mechanically ventilated 3 6.0–11.9 [102-204] 3< 100 and mechanically ventilated 4 > 12.0 [> 204] 4

Glasgow Coma Scale SOFA score Platelets×103/µl SOFA score13–14 1 < 150 110–12 2 < 100 26–9 3 < 50 3< 6 4 < 20 4

Mean Arterial Pressure OR administration of vasopressors required

SOFA scoreCreatinine (mg/dl) [μmol/L] (or

urine output)SOFA score

MAP < 70 mm/Hg 1 1.2–1.9 [110-170] 1dop <= 5 or dob (any dose) 2 2.0–3.4 [171-299] 2dop > 5 OR epi <= 0.1 OR nor <= 0.1 3 3.5–4.9 [300-440] (or < 500 ml/d) 3dop > 15 OR epi > 0.1 OR nor > 0.1 4 > 5.0 [> 440] (or < 200 ml/d) 4

Nonetheless, Sepsis Protocols Remains Valid• New definitions

• Do not change the need to identify early and treat early• Do not affect the CMS measures

• Early management (within 3 to 6 hours)• Stabilization of airway, breathing• Perfusion

• hypotension with fluids• Lactate

• Broad spectrum antimicrobials• Blood cultures first if possible• Guided by likely source and pathogens, if uncertain then vancomycin + broad

gram negative

• Concern about overuse of antibiotics? Not if critical thinking skills utilized

Many URIs are Viral, Even in Inpatient Setting

• Sinusitis• 90-98% viral• Abx if persistent >10d, severe >3-4d, double-sickening

• Pharyngitis: Abx only if rapid strep test• Bronchitis: Abx are not necessary• If bacterial suspected, get cultures• Use respiratory PCR to de-escalate

Chow AW. Clin Infect Dis. 2012;54:e72Shulman ST. Clin Infect Dis 2012’ 55: e86-102Gonzalez. Ann Int Med 2001; 134: 521-9

Break Transmission: Hand Hygiene

Break Transmission: Adhere to Appropriate Precautions

• Standard precautions• Transmission-based

• Contact: direct / indirect• Droplet (large, >5 µm)• Airborne (small, <5 µm)

• Endogenous or devices

Reexamine Role of PPE

JAMA Int Med Oct 12, 2015

How Common is Presenteeism among Healthcare Professionals?

Jena AB. Arch Intern Med 2012; 172: 1107-08

• 51% reported working with flulike symptoms at least once in the past year, 16% at least 3 times

• 30% admitted they or another ill colleague transmitted their illness to a patient

5. Missed Pulmonary Embolism• Headline: Woman, 21, killed by

Pill after nurse missed blood clot• CC: chronic chest pain and

breathlessness, on contraceptives

• Given ibuprofen and told to rest

http://www.express.co.uk/news/uk/636231/Woman-killed-Pill-nurse-missed-blood-clot

Pulmonary Embolism & DVT• Commonly misdiagnosed

• About 1/3 had delayed or misdiagnosis of PE• Among patients with DVT, 1/3 had asymptomatic PE

• Risk factors: prior thrombosis, recent major surgery, hospital admission, CVC, trauma, immobilization, malignancy, pregnancy, OCPs, tobacco

• Common sx: dyspnea (73), pleuritic pain (66), cough (37)• Common signs: tachypnea (54), calf /thigh swelling (47), tachycardia

(24), rales (18)• Lab tests are non-specific• CXR may be normal, but can also show atelectasis, parenchymal

abnormalities, pleural effusion, and cardiomegaly

Torres-Macho. Am J Emerg Med, 2013: DOI http://dx.doi.org/10.1016/j.ajem.2013.08.037

Approach to Diagnosing PE• Assess pretest probability – Wells Criteria (points)

• Symptoms of DVT (3)• No alternative diagnosis to better explain illness (3)• Tachycardia >100 (1.5)• Immobilization ≥ 3d (1.5)• Prior history of DVT or PE (1.5)• Hemoptysis (1)• Malignancy (1)

• D-dimer assay: sensitive, helpful for low or moderate probability• CT pulmonary aniogram, V/Q scan, lower extremity ultrasound• Treatment: anticoagulation

Score >6: High probabilityScore >=2 and

<=6:Moderate probability

Score <2: Low Probability

Error Prevention for Common Misdiagnosed Conditions• Investigate

• Complaints related to these conditions

• Risk factors related to those conditions

• Consider atypical symptoms and age considerations

• Document• H&P, phys exam, pertinent

negatives• Rationale for giving or

withholding treatment

• Review / follow up• All lab studies and compare

with previous• Avoid reliance on single test

result, esp if negative or equivocal

• Delinquent follow ups: establish system in writing

• Communicate• Consider referral• Educate patients re: risk factors

How Documentation Helps

• It provides proof you did the right thing• Supports idea you gave adequate thought and consideration to

the case• Tips

• Document your advice• Document thought process and differential• Legibility• NEVER, NEVER, alter after the fact• Don’t editorialize

Source: J. Davenport, MD JD accessed at http://www.aafp.org/fpm/20001000/33docu.html

Concepts to Improve Patient SafetyCommunicating and follow upManage fatigue & burnout

Case Presentation: No News May Not Be Good News• A 24 year-old male with no previous medical history was

admitted for 3 days of fever up to 103, headache 9/10, eye pain, photophobia and mild sore throat

• PMH: GERD and Crohn’s disease• Medications: omeprazole, Tylenol & Vicodin PRN• SH: No tobacco or drug use; social EtOH; no information about

sexual history or orientation is obtained• PE: T 102.1, HR 80, RR 18, BP 128/76, O2 100% RA

• No acute distress, no meningismus, no rash• Labs: CBC, CMP WNL

CP, continued

• The resident diagnoses patient with a viral syndrome; started on ceftriaxone and vancomycin

• Blood cultures drawn – eventually negative• Meningitis is ruled out with a lumbar puncture, which is negative• Monospot, beta strep group A are ordered and negative• An HIV PCR quantitative test is ordered

• The next day, patient is feeling better, 8/10. On hospital day 3, patient is discharged, with instructions to follow up with PCP and attending agrees

CP, continued

• Patient follows up with PCP…8 months after discharge.• He has 7 additional visits in his PCP office for URIs, physical

exams• 2 years after discharge, he spends time at Disney Gay Days,

gets screened for HIV by DOH via rapid test, which is positive• PCP looks back in the electronic medical record and finds that

HIV Quant VL is >10,000,000

Background: Laboratory Testing

• Adage: “If you ordered it, you own it”• Failure to follow up radiographic and laboratory testing is a

significant cause of medical errors• Fastest growing area of malpractice litigation involves failures or

delays in diagnosis• Up to 25% of these lawsuits are from avoidable failures in the test

follow-up system

Laboratory Testing in the Ambulatory Setting• Almost one quarter of all medical errors in ambulatory settings

are due to inadequate follow-up of abnormal test results• In one study, 15% of abnormal tests suggestive of diabetes

were never followed up by clinicians; about 9% of these patients had unrecognized (and untreated) diabetes

• In another, primary care practice over a 4-year period, the median time for follow-up for marked hyperkalemia was 3 days. In 14% of these cases, no follow-up occurred until patients returned for routine follow-up or they visited the practice for other reasons

Reasons for Missed Test Results

• Hospitalists and ED: “out of sight, out of mind”• Not because we don’t lack effort: physicians report spending

more than 70 minutes per day on test result management, reviewing more than 1000 results per week on average

• Largely a system problem: automated systems can help, but not every issue has an automated system solution

Root Cause Analysis

• Process to identify underlying (basic or causal) causes of medical error

• Focus on systems / processes, not individual• Seeks to answer

• What happened? What should have happened? • Why did it happen?• How can we prevent from happening again?• How do we know that our actions improved patient safety?

RCA Analysis Steps Overview

1. Get interdisciplinary team 2. Reconstruct sequence of events

• Review available data / documents / resources• Generate questions, perform site visits, interviews • Flow diagram: what happened?• Construct ideal sequence of events

3. Identify and categorize root causes and contributing factors

RCA Analysis Steps Overview

4. Develop and implement risk reduction strategy (action plan)• Stronger: physical, permanent, forced functions• Weaker: procedural, temporary• Avoid individual blame

5. Develop outcomes measurement6. Feedback to stakeholders, leadership, and regulatory

agencies

Improving Results Management and Implementing Solutions• Policies and systems to be designed for clear handoffs,

communication with the PCP• Hospitalists need to have a system to follow up lab tests on

discharged patients• Primary care physicians should have access to hospitalization

records

Have you had any of the following in the past week?• Skipped a meal• Worked without taking a break• Changed family / personal plans because of unexpected work

issues• Slept less than 5 hours

PhysicianBurnout, by

SpecialtyPhysicians more likely to have burnout vs control population (38% v 28%)

Shanafelt TD. Arch Intern Med. 2012;172(18): 1377-1385

Medscape 2015 Survey:

Causes of Physician

Burnout

http://www.consumerreports.org/cro/health/doctors-and-hospitals/what-you-dont-know-about-your-doctor-could-hurt-you/index.htm

http://www.vox.com/2016/3/15/11157552/medical-errors-stories-mistakes

The 2nd Victim• 400 physicians commit

suicide annually (2x non-physicians)

• 10% of MS4 & interns have suicidal thoughts

http://www.nytimes.com/2014/09/05/opinion/why-do-doctors-commit-suicide.html

Sean O’Rourke, 26 NYU Grad

Ways to Prevent Burnout• Cognitive-behavioral training (making time to unwind

physically and mentally)• Mindfulness stress reduction• Exercise• Hobbies

• Friendship and social support• Job control over work hours & schedule• Physician Support Services for your institution

Ruotsalainen JH et al. Preventing occupational stress in healthcare workers. Cochrane Database Syst Rev. 2014 13;11:CD002892Portoghese I. Saf Health Work 2014; 5(3): 152-157

In Summary

• Regardless of the estimates, more can be done to improve outcomes for patients by practicing safer medicine and preventing errors

• Cancer, pulmonary, infections, stroke / cardiac, neurologic• Transparency with patients• Good communication by following up of test orders• Optimize our own physical and mental conditions so we can

practice at our best, and avoid being the 2nd victim