prevention of medical errors fs 456.013(7)

Prevention of Medical Errors FS 456.013(7)

Presented byDebra Davidson, MJ, ARM, CPHRM

Patient Safety Department

A Risk Management Seminar for Physicians

Indiana Osteopathic Association December 8, 2012

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Disclosure

We would like to disclose that Debra Davidson, as an employee of The Doctors Company, has a financial interest in The Doctors Company, an organization that may have a direct interest in the subject matter of this CME presentation.

Prevention of Medical Errors / 2

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Course Objectives

At the conclusion of this presentation, participants will be able to:• Describe a root-cause analysis• Recite the most “misdiagnosed” conditions• Recognize medical error reduction and

prevention measures• Identify patient safety goals• Meet the requirements of FS 456.013(7)

Prevention of Medical Errors /

4Prevention of Medical Errors /

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Error Definition

• Adverse Event: Injury caused by medical management rather than

the underlying illness or condition of the patient

• Malpractice: Failure to exercise that degree of care used by

reasonably prudent physicians in the same or similar circumstances

• Medical Error:A preventable adverse event


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Prevalent Medical Errors

• Nosocomial Infections=103,000 deaths/year1

• Medication errors=1.5 million people/$3.5 billion2 • Medication errors=7,000 deaths/year2

• Allergic reactions=700,000 to ER/year3

• Simple errors=27,000 deaths/year4

• Wrong Surgeries=1,700-2,700/year5

• 1 in 20 admissions=preventable adverse event


1. IOM2. FHA/ASHRM 3. JAMA (10/2006)4. PIAA Newsbriefs 10.16.20065. Archives of Surgery (Sept. 2006)


“Errors must be accepted as system flaws,

not character flaws” —Lucien Leape, M.D.

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Root Cause Analysis

• Structured and process-focused framework• Credible and thorough • Active and latent–what, how, and why

Specific underlying causes Reasonably identifiable Controlled or influenced

• Generate specific recommendations

Primary aim: Avoid culture of individual blame


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R isk P o in ts

3 . _ ______

2 .________

1 .________

C orrec t iveM easu res

C linical

P ro cesses

3 . ___ ____

2 . _ ______

1 . ___ ____

C orrective M easu res

O rgan iza tional

S ys tem s

C ausa l Fac to rs

1 . T ype o f E rror

_______ ____

_____ ______

_____ ______

_____ ______

_____ ______

_____ ______

2 .

_____ __ ___ _ _____ __ ___ _

3 .

M ED IC A L ER R O R

Implementation

1. _______

2. _______

3. _______

Measurement of Effectiveness


Root Cause Analysis (continued)

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Root Causes—Medical Errors

• Communication factors• Unclear lines of authority • Highly variable settings• Varied health care processes• Time pressured environment• System deficiencies• Vulnerable defense barriers• Human fallibility

National Patient Safety Foundation


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Most Misdiagnosed Conditions

FAC 64B8-13.005(c) (MD)FAC 64B15-13.001(3)(f) (DO)*

Wrong site/wrong procedure surgery Cancer Cardiac conditions* Inappropriate opioid prescribing* Neurological conditions Acute abdomen related conditions Timely diagnosis of surgical complications Diagnosis of pregnancy related conditions


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Prevalent Types of Error

• Communication Errors

• System Errors

• Medication Errors


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Most prevalent root cause of medical errors is communication


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Communication Errors

• Failure to educate and inform• Miscommunication• Health literacy issues• Failed crucial conversations• Communication barriers

Physical Emotional Cultural


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Effective Communication

• Patients usually interrupted after ____?• On average, patient would speak _____?• Short-term investment=long-term payoff

Improved compliance Focused interactions Realistic expectations Enhanced rapport


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What’s the Trouble?

How doctors think.by Jerome Groopman, January 29, 2007 Most physicians already have in mind two or three possible diagnoses within minutes of meeting a patient.

Prevention of Medical Errors /The New Yorker

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Low Health Literacy

• 90 million people have literacy related health risks

• 1 out of 5 read at a _______ grade level

• 50 percent understand directions for taking medications correctly


www.npsf.org

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Clinician/Clinician Communications

• Referrals• Diagnosticians• Surgical clearance• Hospitalists• Hospitalization• Handoff: SBAR Report

Situation Background Assessment Response

Prevention of Medical Errors /CHAIN OF COMMAND

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Smart phones


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Communication Error Prevention

• Patient-centric culture• Awareness• Team building • Training• Protocols–checklists

• Eye contact• Slow down• Listen• Language• Visual aids• Limit and repeat• Ask Me 3• Verify with teach back


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Preventing Communication Errors

A patient education program designed to promote communication between health care providers and patients, in order to improve health outcomes.

• What is my main problem?• What do I need to do?• Why is it important for me to

do this?

www.askme3.org


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System Errors

• Increase with medical complexity and numbers involved

• Prevalent adverse events Missed diagnosis Improper performance–wrong surgery


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System Error: Missed Diagnosis

• Most prevalent conditions• Cancer• Cardiac• Neurologic condition• Acute abdomen• Complications–Pregnancy• Addiction, psychiatric conditions and diversion

Prevention of Medical Errors /American

Frequently a concurrent condition

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Missed Diagnosis Root Causes

• Personal bias• Haste• Misguided axioms• Poor history• Inadequate exam• Failed evaluation

and pursuit


• Inadequate follow-up system

• Failure to define parameters

• Inadequate assignment of care management

• Faulty communication of clinical concerns

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Missed Diagnosis: Cancer

• Most prevalent missed diagnosed condition 60%–Serious injury1

30%–Death1 50%–PCP1

2/3–Cancer1 30%–two or more clinicians


Annals of Internal Medicine 4/2006

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Missed Diagnosed Cardiac Conditions

93%–Chest pain59%–ECG ordered50%–ECG misdiagnosed20%–No studyGI most common diagnosis<31% attributed a cardiac origin

77%–Died as a result of dx and tx errors

PIAA AMI Claims Study


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Missed Diagnosis: Neurologic Condition

• Clinical examination Age Traditional vascular risk factors Significance of presenting complaints

• Vomiting Neurologic examination

• Gait testing• Vision

Fixation on other medical conditions

Prevention of Medical Errors /PIAA AMI Study

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Missed Diagnosis: Neurologic Condition (continued)

• Diagnostic testing Failure to perform brain imaging Failure to recognize limitations in imaging Failure to pursue other diagnostics Failure to consider in-hospital observation Failure to obtain neurologic consultation


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Missed Diagnosis: Acute Abdomen

• Appendicitis • Esophageal varices• Abdominal aortic aneurysm• Peptic ulcer disease• Hernia of abdominal wall• Cholecystitis/lithiasis• Ectopic Pregnancy• Diverticulosis• GERD


PIAA Data Sharing System Report 1985-2007

Encountered in 5-10% of all ER visits

• Renal stones• SBO• Hiatal hernia• PID• Pancreatitis• Colitis• IBS• Gastroenteritis

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Missed Diagnosis: Pregnancy and Its Complications

• Failure to diagnose Ectopic Pregnancy Gestational Diabetes Pre-Eclampsia/Eclampsia

• Failure to diagnose pregnancy prior to treatment Routine radiology Invasive diagnostics Medications deemed high-risk for pregnancy Other pertinent treatment initiatives


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Diagnostic Error Prevention

• Triage–H&P · • Evaluate and document signs and symptoms• Diagnostic pursuit–index of suspicion• Define parameters• Referral and follow-up ·• Clarify responsibilities • Manage non-compliance• Monitor follow-up appointments


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Diagnostic Error Prevention (continued)

• Childbearing–testing • Communicate and document plan

Education Diagnostics Treatment Follow-up

• Diagnostics Physician review Communicate Tracking/Recall


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Diagnostic Error Prevention (continued)

• Tracking and recall systems Failure to follow up diagnostic results–significant 80%–one delay in reviewing results over two months 1 in 5=delays >five times 30%–medical practices fail to document review Approximately 74 minutes/day managing results


Archives of Internal Medicine. 2009;169(17):1578-1586.

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Data Pending

SPECIMENS Pap C&S Biopsy

RADIOLOGY Chest X-ray MMG DEXA US

___ CT/MRI____


LABORATORY CMP BMP Electrolyte Panel Hepatic Function Panel Lipid Panel Obstetric Panel Hepatitis Panel CBC PT w/ INR Hemogram Amylase FSH Glucose________ PSA TSH_________ UA

Referral Notes/Records________ Referrals________ Records

Patient: Date: ___ ____

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System Error: Wrong Surgery

• 58% ambulatory settings • 29% in-patient OR • 13% other in-patient settings–ER, ICU • 76% wrong body part or site • 13% wrong patient• 11% wrong surgical procedure

________________________________________

• Communication–78% of cases• Orientation and training–45% of cases


Joint Commission on Accreditation of Healthcare Organizations

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Wrong Surgery Root Causes

• Communication breakdown• Poor patient preparation • Wrong information provided by patient/parent• Errors in consent form and medical records• X-ray interpretation and report language errors• Emergent situations• Unusual time pressure, equipment, or set-up• Morbid obesity• Multiple procedures–multiple surgeons • Clinician error


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Case Summary

• Two (F) patients scheduled for breast surgery on 2/14 by same surgeon

• Surgeon arrived after first patient prepped and draped • Performed (R) total mastectomy due to breast cancer• Enters holding area–met by nurse and informed that

his mastectomy patient was “ready”• First patient scheduled for right breast biopsy only • Suit• Disciplinary action


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Surgical Complications

• Most claims have acceptable medical complications• Failure to supervise/monitor post-op most prevalent

root cause of medical error • Prevalent post-op complications:

Infection Perforation Suture failure Bleeding

• Foreign body retention–res ipsa loquitur


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Case Summary

HX: 52 y/o male w/ hx of sleep apnea. Obese. Smoker.

Procedures: R inguinal hernia repair, abdominoplasty, blepharoplasty

Orders: Morphine 4 mg IV q 4 h prn. Valium 2 mg IV q 4-6 h prn. Monitor. I&O. SCDs. Ambulate ASAP.

Actual Care: Morphine 4 mg IV q 2 h. Valium 2 mg IV q 2 h.

Outcome: Patient agitated. Restless. Oxygen sats. dropped. SOB. Vomited. Aspirated. Respiratory arrest.

Code initiated unsuccessfully. Patient expired.


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Wrong-Site Surgery


FAC (2) “…requiring the team to pause.”(b) “…The notes of the procedure...”

Florida Statute 456.072(1)…“Performing or attempting to perform… … includes the preparation of the patient.

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Department of Health

• Wrong-Site Sanctions (first offense) Letter of Concern $5,000 fine Costs of investigation and processing (@$2,500) Five CME’s Risk Management One hour lecture–develop and deliver


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In the News…

Text of Duke's Letter to UNOS Explaining Transplant MistakesPosted: Feb 21, 2003 Durham, NC—The following letter was sent Friday to the United Network for Organ Sharing (UNOS).

Duke University Hospital has completed the initial phase review of the events related to the heart/lung transplant from donor _______. We provide the following to promote our joint efforts in the peer review of this incident and for the purpose of performance improvement.

We have concluded that human error occurred at several points in the organ placement process that had no structured redundancy.


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West Boca High cheerleader got fraction of drug needed, lawyer charges


http://www.legacy.com/PalmBeachPost/GB/GuestbookView.aspx?PersonId=106299559

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Surgical Error Prevention

• Identification• Technology–bar-coding/photo ID• Verification protocol • Mark site • Patient education and preparation• Consent/Education• Prophylactic ATB• Protocols• Training



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Surgical Error Prevention (continued)

• Document normal and abnormal findings• Pre and Post-evaluations• Pre and Post-diagnostics • Pre and Post-instruction• Follow-up• Supervision• Team building• Communications



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Medication Errors

• 6.5% in-patients–ADEs• Leading cause of harm in hospitals• 28% preventable• 62%–ordering and transcription



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Top Products—Medication Error

• Insulin• Albuterol• Morphine• Heparin• Cefazolin• Warfarin

Prevention of Medical Errors /MEDMARX/USP Drug Safety Review

• Furosemide• Levofloxacin• Vancomycin• KCI (potassium chloride)• Curare-type paralytics


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Medication Error Root Causes

• Illegibility• V.O. and T.O.• Abbreviations• Multiple medications• Multiple prescribers• Multiple “handoffs”


• Concentrations• LASA medications• Patient understanding• Monitoring• Unfamiliar medication•


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Coumadin or Avandia?


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Case Summary

CC: Decreased thyroid levelHx: 52 y/o female treated for three years with

Synthroid. Thyroid level dropped requiring increase in dosage.

Physician wrote order in progress notes for new dosage. MA transferred order from progress notes to prescription pad. Physician used abbreviation for micrograms. MA used abbreviation for milligrams.

Patient received overdose.


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Official JCAHO “Do Not Use” List

Do Not Use Potential Problem Use Instead

U (unit) Mistaken for “0” (zero), Write “unit”IU (International Unit) Mistaken for IV (intravenous)

or the number 10 (ten)Write “International Unit”

Q.D., QD, q.d., qd (daily)Q.O.D., QOD, q.o.d, qod(every other day), q.i.d. (four times daily)

Mistaken for each otherPeriod after the Q mistaken for“I” and the “O”mistaken for “I”

Write “daily”Write “every other day”Write “four times daily”

Trailing zero (X.0 mg)*Lack of leading zero (.X mg)

Decimal point is missed.2 2 mg 2.0 20 mg

Write “X mg”Write “0.X mg”


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Abbreviations, Acronyms, and Symbols

Do Not Use Potential Problem Use Instead> (greater than)< (less than)

Misinterpreted as the number “7” (seven) or the letter “L”Confused for one another

Write “greater than”Write “less than”

Abbreviations for drug names

Misinterpreted due to similar abbreviations formultiple drugs

Write drug names in full

Apothecary units Unfamiliar to manypractitioners. Confused with metric units.

Use metric units


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Abbreviations, Acronyms, and Symbols (continued)

Do Not Use

Potential Problem Use Instead

@ Mistaken for the number“2” (two)

Write “at”

μg Mistaken for mg (milligrams) resulting in one thousand-fold overdose

Write "mcg" or “micrograms”

cc Mistaken for U (units) whenpoorly written

Write "ml" or “milliliters”


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LASA Medications

• Klonopin (anti-anxiety)–Clonidine (anti-hypertensive) • Lanoxin (heart failure/AF)–Levoxine (Thyroid tx)• Evista (osteoporosis)–Avinza (extended release Morphine) • Alprazolam (anti-anxiety)–Lorazepam (anti-anxiety) • Lamisil (anti-fungal)–Lamictal (anti-seizure)

Prevention of Medical Errors /JACHO 2005 National Patient SafetyPA-PSRS Patient Safety Advisory

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LASA Medications

• Hespan (volume expander)–Heparin (ATC)• Omacor (triglyceride reducer–Amicar (enhances hemostasis)• CIPRO–CIPRO XR• VICODIN–VICODIN ES• Amaryl (antidiabetic)– Reminyl (Alzheimer’s treatment)• Reminyl renamed–Razadyne

Prevention of Medical Errors /JACHO 2005 National Patient SafetyPA-PSRS Patient Safety Advisory

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Case Summary

HPI: 22 y/o female c/o persistent abdominal pain

Hx: Appendectomy w/ p.o. nausea

Plan: Exploratory laparoscopy w/ Anzemet IV pre-operatively

Outcome: c/o abdominal pain, nausea, extreme panic apnea → cardiac arrest


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Zyrtec vs Zyprexa

LASA Medications


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Medication Error

HX: 9-month-old hospitalized w/ acute asthmatic bronchitis and pneumonia

Rx: IM administration of ATB at 75% of recommended adult dose

Outcome: ATB-induced ototoxicity–permanent deafness

RCA: “NOT FOR PEDIATRIC USE” on label and insert, Clark’s Rule 13%, no review, no parental warning


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Medication Error Prevention

• Electronic ordering or fax• Pre-printed scripts• Brand and generic names• Medication’s purpose • Limit V.O. and T.O.• Refill protocols• Medication history and current profile• Medication/Allergy alerts


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Medication Error Prevention (continued)

• Review chart• Caution with symbols, abbreviations, and

decimals (e.g., 0. and .0)• Storage and Labeling–LASA• Limit concentrations• Written information• Warnings • Delegation • Competency evaluation


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In the News…

• Hospital Accused of Overdosing Quaid's Twin Babies

• Cedars Allegedly Gave Infants 1,000 Times More Heparin Than Needed

• Posted: 8:40 AM EST November 21, 2007• Updated: 11:23 AM EST November 21, 2007


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Case Summary

CC: 76 y/o w/ shoulder rash

Hx: ED. CAD. ASCVD.

Dx: Ringworm

Tx: Ketoconazole 200 mg; Levitra 20 mg samples

Outcome: Patient expired seven days later– Acute cardiac episode


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MEDICATIONS Patient:______________________________________DOB: ______________________ Allergies: _______________________________________________________________ Date Medication Dose Frequency Samples Pharmacy Refill/MD Refill/MD Refill/MD Refill/MD


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ANTICOAGULANT THERAPY

PATIENT:_____________________________________________________________

DATE PT INR DOSAGE INSTRUCTIONS INITIALS


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Patient Safety Guidelines and Safety Systems

• Triage• Record keeping• Referral process• Track and follow-up• Assignment of care• Practice guidelines• Communication • Monitor• Education and training


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“Make it easy to do right and difficult to do wrong.”

- Dr. Lucian Leape


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Disclosing Medical Error

FS 456.0575–Duty to notify patients. Every licensed health care practitioner shall inform each patient, or an individual identified pursuant to FS. 765.401(1), in person about adverse incidents that result in serious harm to the patient.

Notification of outcomes of care that result in harm to the patient under this section shall not constitute an acknowledgment of admission of liability, nor can such notifications be introduced as evidence.


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Disclosing Medical Error (continued)

• Seek legal/risk management guidance• Communicate• Express concern/empathy• Do not blame• Present a plan• Confirm understanding• Document


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Documentation

• Date, time, and place • Individuals present • Informant(s)• Information conveyed

Known facts r/t Condition, treatment, occurrence

Immediate and long-term effects Current and future interventions


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Documentation (continued)

• Questions posed and responses• Offer of assistance• Treatment plan agreed upon• Agreement for follow-up meetings• Reason for incomplete disclosure• Follow-up


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2012 National Patient Safety Goals

• Patient ID• Medication safety

Reconciliation• Prevent infection• Prevent surgical mistakes• Communication• Patient risks

Recognition and response


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Click to edit Master title style

Click to edit Master text styles Second level

Third level– Fourth level

» Fifth level

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“The pessimist complains about the wind;

the optimist expects it to change; the realist adjusts the sails.”

--William Arthur Ward


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Your Role in Reducing Medical Error

• Establish culture• Promote effective team functioning• Anticipate the unexpected• Create an environment of trust and cooperation


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Mission Statement

Our Mission Is to Advance, Protect, and Reward the

Practice of Good MedicineFor further Patient Safety information,

please visit our Web site at:www.thedoctors.com


[email protected](800) 421-2368, ext. 4005

prevention of medical errors fs 456.013(7)

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