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Page 1: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

1

Page 2: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

Your Presenters Today Are…….2

Becky Simer RN BSNetwork Performance Improve Manager for p g

IA/NEPCA

And

Linda Ruble ARNP PA

Clinical Consultant for HRSA and IA/NEPCA

Page 3: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

Clinical Risk Clinical Risk Management: 101g

3

AN OVERVIEW PRESENTATIONF O R

MIDWEST CLINICIANS NETWORKMIDWEST CLINICIANS NETWORK

WEBINAR & PHONE

THURSDAY, OCTOBER 8, 2009

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DEFINITION of “RISK MANAGEMENT”4

RISK: The possibility of loss or injury; peril; a dangerous element

MANAGEMENT: The act or art of conducting or supervising something or the judicious means to supervising something or the judicious means to accomplish an end.

RISK IN HEALTHCARE: The probability that something undesirable will happen –implied need for avoidance.avoidance.

Page 5: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

THINK: Murphy’s LawTHINK: Murphy s Law

If 5

If something something

can go can go wrong, it wrong, it

will…will…

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SO, PREPARE!!!Our goal is to identify the y“dangerous elements” in our

i t environment, processes and products and products, and minimize the possibility of loss, injury, and…. (yes) peril.

6

Page 7: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

FTCA (Federal Tort Claims Act)( )Claims Data2004 - 20084

7

THERE ARE 937 FTCA DEEMED

HEALTH CENTERS, REPRESENTING

87% OF THE TOTAL NUMBER OF

HEALTH CENTERS (CY2009)

Page 8: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

HRSA National Medical ClaimsSTATE INFO:

h // h / / i i / /

Total Claims by Nature of Occurrence (2004 ‐ 2008)

https://eroom.hrsa.gov/eRoom/LearningCommunity/PCAroom/0_2e44 8

60

80

0

20

40

2004 2005 2006 2007 2008

Diagnosis  Related                   54 48 68 75 67

Obstetrics  Related                  55 68 57 55 73

Treatment Related                   54 31 25 53 59

Medication Related                  19 25 16 33 35

2004 2005 2006 2007 2008

Surgery Related                     7 14 15 10 22

NULL 24 22 3 15

Other Miscellaneous                  6 3 1 5

Page 9: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

HRSA Medical ClaimsStandard of Care Met or Not Met

Standard of Care (2004 ‐ 2008)9

133 126 92008

85 100 7

121 96 26

2006

2007

117 86 27

91 97 28

2004

2005

0% 20% 40% 60% 80% 100%

Met Not Met Unable to Determine

Page 10: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

HRSA Claims by Secondary Factors IdentifiedIdentified

Secondary Factors Identified (2004 ‐ 2008)

10

120

140

40

60

80

100

0

20

Documentation 106 100 80 120 139

Policies/Protocols/Procedures 103 77 65 125 114

2004 2005 2006 2007 2008

/ /

Training/Lack of Supervision 37 87 72 110 134

Communication 3 28 21 93 89

No Secondary Factors  Found 50 29 51 38 42

Referral  Issues/Recurring Complaint 15 5 4 39 19

St ffi /A il bil it /S h d li 24 4 8 9 18

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11

[FOR THIS PRESENTATION

ONLY]

This SymbolThis Symbol,

Represents

EMR

Project

Enhancement

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Primary Liabilities forPROVIDERSPROVIDERS

12

Lack of documentation of treatment

Inadequate work-up (based on accepted standards)

Acts of others (e.g. nurses) if exercising control

Failure to follow upFailure to follow up

Mistaken identity (provider and center)

Mi di i if b d i d i i d iMisdiagnosis, if based on inadequate examination and testing

Wrong diagnosis followed by improper treatment causing injury

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MORE Primary Liabilities for PROVIDERS13

Wrong treatment or procedure based on diagnosis.

Treatment outside field of competence (or not privileged for)Treatment outside field of competence (or not privileged for)

Abandonment (neglect or failure to follow up after the acute stage of illness – unilateral termination of the physician patient relationship without notice to the patient)

Failure to obtain full informed consent

Failure to see consultation or refer to a medical/surgical specialist

Use of unprecedented procedures, unless approved by a respectable minority of medical opinionp

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MORE Primary Liabilities for Providers

Failure to order diagnostic tests that are considered to be a

14

g“matter of common knowledge”

Failure to obtain results of diagnostic tests orderedFailure to obtain results of diagnostic tests ordered

Infections resulting from failure to utilize proper procedures or precautionsprecautions

Aggravation and/or activation of a preexisting condition if injury resultsresults

Premature dismissal or discharge of patient

Page 15: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

Primary Liabilities Primary Liabilities of NURSES

Administration of drugs inconsistent with prevailing statutes,

15

Administration of drugs inconsistent with prevailing statutes, nurse practice acts, or institutional policies

Failure to follow provider ordersFailure to follow provider orders

Failure to report significant concerns or changes in a patient’s condition

Failure to take correct verbal or telephone ordersFailure to take correct verbal or telephone orders

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A FEW More for NURSES…16

Patient burns

P ti t f llPatient falls

Failure to report defective equipmentFailure to report defective equipment

Failure to follow established policies or procedures

Negligent handling of patient valuables

Page 17: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

What About “Negligence”?17

As a basis for malpractice

• “Proper Care” is based on a defined standard established by law to protect others malpractice,

negligence means lack

law to protect others against harm; in medical malpractice, “proper care” is judged by peers;means lack

of proper or reasonable

y p

• “Reasonable Care” means there is both a rationale for doing and

careg

for not doing, and that rationale is the basis for decision making

Page 18: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

NEGLIGENT CONDUCT

Doing what a reasonable person would not do

18

Doing what a reasonable person would not do

Failure to do what a reasonable person would do:

• Exercise reasonable care• Protect or assist another

[Contributory negligence: A plaintiff’s proven contribution to his or her own harm, perhaps forcing f f it f l i ]forfeiture of claim]

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BURDEN OF PROOF forNEGLIGENCE

ALL THREE (3) elements must be proven!!! 19

1) BREACH of DUTY – Based on policies or procedures, or reasonable standards of care (laws, regulations, or peers)DUTY

Ensure patient’s safety throughout “transaction” (visit)Protect from foreseeable harmProtect from malpractice

2) MEASURABLE HARM -- (Injury)2) MEASURABLE HARM (Injury)

3) CAUSATION – (The breach of duty caused the injury)

Page 20: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

Highest Number of Claimsin AMBULATORY CARE by SPECIALTYin AMBULATORY CARE by SPECIALTY

Internal Medicine TOP ALLEGATIONS

20

TOP ALLEGATIONS• Failure to diagnose• Failure to perform

Family Practicep

surgery• Improper performance of

tests or procedures

Ob/Gyn

tests o p ocedu es• Delay in diagnosis• Improper management

of course of treatmentOb/Gyn of course of treatment• Failure to communicate • Lack of informed consent

Page 21: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

RISK MANAGEMENT is….

An ORGANIZATIONWIDE PERFORMANCE IMPROVEMENT PROCESS

21

IMPROVEMENT PROCESS

considered by most references to be one key component of the giant quality umbrella

Page 22: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

Risk management needs good outcomes; d t i d litgood outcomes require good quality

management

Quality

Management

22

g

Good

Risk Management

Good Outcomes

Page 23: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

QI and RM Share…

A commitment to eliminate or reduce problems in patient care and maximize patient safety

23

patient care and maximize patient safety

Concern for prevention of harm and loss

EFFECTIVE RISK MANAGEMENTS EMPHASIZES “HARM PREVENTION” FOR PATIENTS, HARM PREVENTION FOR PATIENTS,

VISITORS AND STAFF MORE

THAN FINANCIAL LOSS.

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RISK MANAGEMENT andRISK MANAGEMENT andQUALITY MANAGEMENT

GO “HAND-IN-HAND”

“QUALITY IS THE OPTIMAL

GO HAND IN HAND24

“QUALITY IS THE OPTIMAL ACHIEVEMENT OF THERAPEUTIC

BENEFIT AND AVOIDANCE OF RISK AND MINIMIZATION OF

HARM.”T H E J O I N T C O M M I S S I O N J O C O S S O

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QI and RM Share…

Improved processes for QI enhances RM

25

Improved processes for QI enhances RMBoth benefit from efficient resource utilization and minimal effort duplicationBoth are committed to reducing problems for patients and maximizing their safety and good careBoth are concerned for prevention of harm and loss.Both are concerned for prevention of harm and loss.

RISK MANAGEMENT and QUALITY IMPROVEMENT h t l have mutual “CAUSATIVE, POSITIVE CORRELATION”!!!

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CLINICALCLINICALRISK MANAGEMENT

FOR

26

FOR

AMBULATORY CLINICS

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RISK MANAGEMENT Specific toAmbulatory Clinics or Health Centers

Patient scheduling must be defined by written protocols.

27

Patient scheduling must be defined by written protocols.

Have clear guidelines for triage, especially for emergency d t i itand urgent visits

Missed appointments should be brought to the providerd doc mented in the medical eco dand documented in the medical record

Keep appointment records for as long as the clinic records are keptare kept

Maintain clear policies for triage or urgent visits and stick to themto them

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RISK MANAGEMENT Specific toAmbulatory Clinics or Health CentersAmbulatory Clinics or Health Centers

28

Have written policies for patient tracking of referrals and diagnostic follow up

• Log labs, diagnostic tests and referrals; keep tickler fileg g p• If serious and cannot contact patient, send certified letter

Keep tickler of recommended preventative testing and document informed refusals

• One role is held accountable for maintaining up-to-date follow up

Keep medication sheet in MR with date, name of med ordered, dose, quantity, # of refills, provider’s initials, staff initials, and any adverse reactions.

Document and check allergy status consistently

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RISK MANAGEMENT Specific toAmbulatory Clinics or Health Centers

Referrals

29

Referrals• Document referrals in chart with timeframes• Document conversations between providers• Send pertinent records• Include all patient communications• Develop procedure to monitor receipt of

consult reports• Providers must review and initial ALL

t b f ddi t MRreports before adding to MR

Page 30: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

Patient Education

Review all written materials for accuracy before adopting th

30

them

Create policies for readability regarding health literacy and l l di i i d i i lcultural diversity in education materials

Maintain a master file and archived files of all patient d l l h d deducation materials along with dates used

Have patients confirm understanding of instructions and p greturn demonstration if applicable

Ask provider and patients to sign off on important p p g pinstructions

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RM for Clinics

Give and get report after practice coverage. Put documentation in patient charts

31

Locum Tenens: Credentialing and privileging is essential, along with abbreviated orientation

Triage Policy and Telephone Protocols:

• Consider checklist form organized by S/S or pt. complaint• With triage, err on the site of caution with appointments. or referrals to

urgent care or ER• PULL CHART and check medical record if symptomatic

Receptionists can handle administrative calls but NURSES SHOULD HANDLE CALLS THAT INVOLVE PATIENTS WITH SYMPTOMS. These calls should be documented in the medical recordrecord.

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INFORMED CONSENT

Remains a persistent basis for liability claims

32

Remains a persistent basis for liability claims

Responsibility belongs to the care provider who is to conduct the proposed test or treatmentproposed test or treatment

Support staff may have the patient read but not sign, prior to the provider’s review with the patientprovider s review with the patient.

Exceptions:

• Life threatening illness or injury needing immediate attention• Patient cannot communication or take part in communication• There is no time to secure treatment authorization from someone else who is

l ll d t t ti t’ b h lflegally empowered to act on patient’s behalf.

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MEDICAL ERRORS

33

“ A N A C T O F C O M M I S S I O N ( D O I N G

S O M E T H I N G W R O N G ) O R O M I S S I O N

( F A I L U R E T O D O T H E R I G H T T H I N G ) T H A T ( F A I L U R E T O D O T H E R I G H T T H I N G ) T H A T

L E A D S T O A N U N D E S I R A B L E O U T C O M E O R

S I G N I F I C A N T P O T E N T I A L F O R S U C H A N S G N C N O N O S U C N

O U T C O M E ”

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“CATEGORIZATION” of Medical Errors

“A ti E ” t th “Sh E d” t

34

“Active Errors” or errors at the “Sharp End” occur at point of contact between a human and some aspect of the system (e.g. instrument, machine) or patient

“Latent Errors” or errors at the “Blunt End” occur through failures of organization, design, or layers of the g g , g , yhealthcare system affecting the human making contact

“Error Chain” is a series of events that lead to an Error Chain is a series of events that lead to an adverse outcome, typically uncovered by a “root cause analysis” (Swiss Cheese Model)

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Taking a Risk with Swiss Cheese Demonstration35

http://lessons.workforceconnect.org/reflib/defanp // g/ /

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The SWISS CHEESE ERROR Model36

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And “TYPES” of ERRORS

Error: Failure of a planned action to be completed as intended

37

p por use of a wrong plan to achieve an aim

Adverse Event: An injury resulting from a medical interventionAdverse Event: An injury resulting from a medical intervention

Serious Error: An error causing permanent injury or transient but potentiall life threatening harmbut potentially life-threatening harm

Minor Error: An error causing harm that is neither permanent nor life threateningnor life-threatening

Near Miss: An error that could have caused harm but did not, either by chance or interventioneither by chance or intervention

Page 38: Your Presenters Today Are……. - Training Source › Courses › CHC › risk... · 2012-06-15 · 6. FTCA (()Federal Tort Claims Act) Claims Data 2004 - 2008 7 THERE ARE 937 FTCA

Most Common Medical Errors (IHI)38

Missed and delayed diagnoses

Medication errors

Delayed reporting of results

Miscommunications during transitions in care

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UNDERLYING CAUSES ofMEDICAL ERRORS (IHI)

Communication problems

39

Communication problems

Inadequate information flow

H f l d blHuman factors-related problems

Patient-related issues

Organizational transfer of knowledge

Staffing patterns and workflowg p

Technical failures

Inadequate policies and proceduresInadequate policies and procedures

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SBAR (Situational Briefing Model)(Situational Briefing Model)

SBAR facilitates clear communication between staff

40

SBAR facilitates clear communication between staff and providers

SBAR is a standardized situational briefing model

BEFORE using SBAR and talking to provider:

• Assess the situation• Assess the situation• Know the primary diagnosis• Read recent progress notes, assessments, and labs• Have chart or medical record available• Have chart or medical record available

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SBAR (pronounced ‘S’-bar)

SITUATION (I d t t ll b t )

41

SITUATION – (I need to tell you about…)

BACKGROUNDBACKGROUND

ASSESSMENT -- (what has changed)ASSESSMENT -- (what has changed)

RECOMMENDATIONRECOMMENDATION

http://www.ihi.org/ihi/topics/patientsafety/safetygeneral/tools/sbartechniqueforcommunicationasituationalbriefingmodel.htmg

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MEDICATION ERRORS

42

EVENTS RELATED TO MEDICATIONS

A RE THE THIRD-LEADING CAUSE OF

DEATH IN THE US AFTER HEART

DISEASE AND CANCER

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MEDICATION Errorsin Clinics

Incorrect prescribed dosage

43

p g

Incorrect medication for diagnosis or condition

Multiple pharmacy prescriptions

Medication incompatibility

Inappropriate dispensing of sample medsInappropriate dispensing of sample meds

Illegible handwriting on prescriptionsg g p p

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Verbal Orders? No, no!!

Verbal orders (VOs) are a major cause of medication errors

44

VOs should be eliminated except in emergency situations

As an extra check, spell unfamiliar drug names, with “T for Tom” and “C for Charlie”

Pronounce each numerical digit separately saying “one six” instead of “sixteen” to avoid confusion with “sixtyconfusion with sixty

The receiver must ensure that the verbal order makes sense with the patient’s diagnosis

IF VOs are allowed, prescribers must enunciate; receiver should always repeat the order to the prescriber to avoid misinterpretation

The MANDATORY READ BACK policy is essential for critical lab results alsoThe MANDATORY READ BACK policy is essential for critical lab results also

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OTHER RISK MANAGEMENT RULESTO PREVENT MED ERRORS

Al t th i di ti f th di ti th d

45

Always put the indication for the medication on the order

Order should be complete including strength & concentration of medication, route, and rate of administration (if applicable)

Do not use any abbreviations or use very sparingly

NEVER use “DO NOT USE” abbreviations

Verbal orders are used in emergencies only

Script pads are locked and stored away from patient care

Never pre-sign or post-date prescriptions

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MORE MEDICATION ERROR RISK MANAGEMENT RULES

46

Track manufacturer lot numbers

Avoid samples (or review policies for RM)

Monitor expiration dates and remove outdates

Keep medication samples locked

L b f l i i h ld b Lot numbers of any samples given to patients should be recorded in the medical record

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High Risk Patient Populations

Renal/liver impairment

47

/ p

Pregnant/breastfeeding patients

Neonates

Elderly/chronically ill patientsde y/c o ca y pat e ts

Patients on multiple meds

Patients with multiple co-morbidities

Oncology patientsOncology patients

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It d tIt comes down toCOMMUNICATION

48

60% of med errors are caused by mistakes in interpersonal mistakes in interpersonal

communication. (Joint Commission)

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I t d ti t Introduction to National Patient Safety Goals

P R O V I D E D C O U R T E S Y O F T H E

J O I N T C O M M I S S I O N

y49

J O I N T C O M M I S S I O N

FOCUSING ON THOSE RELATED TO

MEDICATION ERRORSMEDICATION ERRORS

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Accurately & completely RECONCILE MEDICATIONS across the continuum of care (Goal 8)

“ h ( b ) f i h

50

“There (must be a) process for comparing the

patient’s current medications with those ordered

for the patient while under the care of the

organization.” g

The Joint Commission

http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/09_amb_npsgs.htm

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Medication Reconciliation

When a patient is referred to or transferred from one

51

porganization to another, the complete and reconciled list of medications is communicated to the next provider of service and the communication is documented.

When a patient leaves the organization’s direct care directly to his/her home, the complete & reconciled list of medications is

id d t th ti t’ k PCP th i i l f i provided to the patient’s known PCP, or the original referring provider, or a known next provider of service.

h i l h i i ’ l & When a patient leaves the organization’s care, a complete & reconciled list of the patient’s medications is provided directly to the patient & the patient’s family as needed, and this list is explained to the patient and/or family explained to the patient and/or family.

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“DO NOT USE” ABBREVIATION LISThttp://www.jointcommission.org/PatientSafety/DoNotUseList/

52

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There are TONS of TIPS for“Implementing Elimination of

Dangerous Abbreviations”…

HTTP://WWW JOINTCOMMISSION ORG/

g53

HTTP://WWW.JOINTCOMMISSION.ORG/

PATIENTSAFETY/N A T I O N A L P A T I E N T S A F E T Y G O A L S / A B B R _ T I P S . H T M

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L k Alik S d Alik M dLook Alike – Sound Alike Medsfor AMBULATORY CARE

“LASA” MEDICATIONS

54

LASA MEDICATIONS

HTTP://WWW.JOINTCOMMISSION.ORG/N R / R D O N L Y R E S / C 9 2 A A B 3 F A 9 B D 4 3 1 C 8 6 2 8N R / R D O N L Y R E S / C 9 2 A A B 3 F - A 9 B D - 4 3 1 C - 8 6 2 8 -

1 1 D D 2 D 1 D 5 3 C C / 0 / L A S A . P D F

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Confusing Drug Names

•Losec (Omeorazole) and Lasix (Frusemide)

55

•Avanza (Mirtazapine) and Avandia (Rosiglitazone)

C l b (C l ib) d C b (F h i )•Celebrex (Celecoxib) and Cerebyx (Fosphenytoin)

and Celexa (citalopram hydrobromide)

•Reminyl (Galantamine) and Amaryl (Glimepiride)

•Diamox (Acetazolamide) and Zimox (Amoxicillin)

•Lamisil (Terbeniafen) and Lamictal (Lamotrigine)

•Taxol (Paclitaxel) and Taxotere (Docetaxel)

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More Confusing Drug Names

Avandia (rosiglitazone) and Coumadin (warfarin)

56

Catapres (clonidine) and Klonopin(clonazepam),

Concentrated Roxanol and oral morphine liquid (traditional concentration)

Hydromorphone injection and morphine injection

Insulin products• Humalog and Humulin, Novolog and Novolin, Humulin and Novolin, Humalog and Novolog, Novolin

70/30 and Novolog Mix 70/30

Lorazepam (Ativan) and alprazolam (Xanax)

T ( i ) d T l l ( l l)Topamax (topiramate) and Toprol-xl (metoprolol).

Flagyl (metronidazole) and Glucophage (metformin)

Z ( l i ) d Z t ( ti i i )Zyprexa (olanzapine) and Zyrtec (cetirizine)

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RISK MANAGEMENT for “LASA’s”

Consider when adding to formulary

57

Use both brand names and generic names when possible

Change appearance of look-alikes on labels and records by bolding, highlighting, or enlarging the letters that are different

Change order on computer screens so they don’t appear consecutivelyChange order on computer screens so they don t appear consecutively

Store in different locations in pharmacyStore in different locations in pharmacy.

Employ independent double checks in dispensing: one interprets and enters into computer; another reviews the printed label against the original prescriptioncomputer; another reviews the printed label against the original prescription

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Who would imagine confusion between h d ?these two products?Zyrtec or Lipitor?

58

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How about even “high-risk di ti ”?medications”?

Avandia or Coumadin

59

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ISMP (I tit t f S f ISMP (Institute for Safe Medication Practices))

H A S P R O V I D E D A L I S T O F

60

HIGH ALERTMEDICATIONS

( S E E A T T A C H M E N T )

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HIGH ALERT HIGH ALERT MEDICATIONS

“ H I G H A L E R T M E D I C A T I O N S ” A R E D R U G S T H A T B E A R A

61

“ H I G H - A L E R T M E D I C A T I O N S ” A R E D R U G S T H A T B E A R A

H E I G H T E N E D R I S K O F C A U S I N G S I G N I F I C A N T P A T I E N T

H A R M W H E N T H E Y A R E U S E D I N E R R O R .

A L T H O U G H M I S T A K E S M A Y O R M A Y N O T B E M O R E

C O M M O N W I T H T H E S E D R U G S T H E C O N S E Q U E N C E S O F A NC O M M O N W I T H T H E S E D R U G S , T H E C O N S E Q U E N C E S O F A N

E R R O R A R E C L E A R L Y M O R E D E V A S T A T I N G T O P A T I E N T S .

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HIGH ALERT MEDICATIONShttp://www.ismp.org/Tools/highalertmedications.pdfp // p g/ / g p

62

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HIGH ALERT MEDICATIONS (ISMP):Purpose of Listp

Improving access to information about these drugs

63

Improving access to information about these drugs

Limiting access to high-alert medications

Using auxiliary labels and automated alerts

Standardizing the ordering, storage, preparation, and administration of these products

Employing redundancies such as automated or independent double checks when necessary

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THE RISK MANAGEMENTTHE RISK MANAGEMENTPLAN

64

AND ITS ESSENTIAL COMPONENTS!

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HRSA FTCA (Federal Tort Claims Act) DIRECTION

PAL 2009-05 (http://bphc.hrsa.gov/policy/pal0905/)

65

Application requires information on the following health center activities:

• Risk Management Systems• Board approved Quality Assurance/Quality Improvement Plan• Board approved Quality Assurance/Quality Improvement Plan• Clinical protocols• Patient records management• Patient follow up and tracking• Incident tracking and reporting• Incident tracking and reporting• Peer review/staff training

• Credentialing Systems• Primary Source Verification

V ifi ti f d ti d t i i b d tifi ti f i l f • Verification of education and training, board certification, professional references, health fitness,

• National Practitioner Data Bank (NPDB) query • Formal Privileging ProcessP f i l Li bilit Hi t• Professional Liability History

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RM Plan Should Include At Minimum:

Policy or statement of purpose

66

o cy o state e t o pu pose

Goals

Scope, including linkages with QM, case management, patient safety, and safety management

Authority and responsibilities of:

• Governing body• Administration• Physicians/Licensed Independent Practitioners• Risk Manager, Quality Manager, Patient Safety Officer(s), Case

Management Director, and other roles

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RISK MANAGEMENT PLAN: Additional Componentsp

C fid i li d C fli f I P li i

67

Confidentiality and Conflict of Interest Policies

Data sources and referrals

Documentation and reporting mechanisms

Integration of activities and information

P l iProgram evaluation

Organizational charts and flow charts as applicableO g pp b

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RISK MANAGEMENT PLAN: Standards68

FOR EXAMPLE:

Risk Management is a leadership (governing body, administration, g p (g g b y, ,medical/professional staff, management) activity linked to quality and safety

Regarding quality and safety, leaders are responsible for organization wide planning for structures and process, establishing priorities for Performance Improvement, including high-risk procedures.…., and designing new or modified processes, while implementing an integrated patient safety modified processes, while implementing an integrated patient safety program.

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Include Description of RM Model and SystemsSystems

DO include organizational model and/or vision (“just culture”) as well as

69

DO include organizational model and/or vision ( just culture ) as well as safety standards, audit practice, and guidelines for occurrence or incident reporting

DO describe tracking & analysis mechanisms for RM and QI

DO NOT use an originating occurrence reporting form itself in any peer review activities. Abstract important information onto a practical tool to utilize for the review

DO NOT document the name of the person originating the occurrence report. It is adequate to state that the issue originated in QM

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RM Models and Systemsy70

FOR SINGLE SITE OR MULTIPLE SITE

CLINIC SETTINGSCLINIC SETTINGS

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Organizational Models forRisk ManagementRisk Management

71

A RM Committee (may be closely linked to QI Committee: subcommittee or regular component of QI agenda)

A RM Director or Coordinator (may be part of QI or Compliance role)

S per isors and managers ork ith designated RM Lead • Supervisors and managers work with designated RM Lead to report occurrences and potential adverse events; possible risk factors; and department specific and organization wide safety initiativesorganization wide safety initiatives

Smaller Clinics: Center Manager or Director incorporates risk management plan into daily operations

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Clinical Risk Management Models

Early Warning System

72

Early Warning System

An organization-wide system to screen all patients

and systems for real or potential adverse incidents,

issues, and occurrences that might result in

increased risk to the organization and/or less than

optimal quality of care

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Clinical Risk Management Models

Generic Screens -- Used to concurrently screen every ambulatory

73

Generic Screens Used to concurrently screen every ambulatory patient encounter for given time periods. Covers all important aspects of a visit; or may be modified according to specific concerns or services

• A general adverse outcome criteria set serves a warning for a A general adverse outcome criteria set serves a warning for a claim or increased risk, which is then proactively addressed. This method is statistically effective in identifying nearly all occurrences.

Adverse Patient Occurrences (APOs) – Unexpected untoward events with actual or potential negative impact on the patient

Potentially Compensable Events (PCEs) -- Those APOs that might become claims based on the degree of actual or potential negative impact on the patienton the patient

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Clinical Risk Management Models forPredicting Adverse Eventsg

74

Use analysis and historical data to predict potential for adverse occurrence, degree of risk, and to estimate financial impact on the organization in case of occurrence

Prioritize risks by frequency, severity, and potential for reduction

Investigate potential risksInvestigate potential risks

Map processes and systems and analyze for risk reduction

Utilize PDSA’s to identify improved processes to eradicate identified risk

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DATA COLLECTION DATA COLLECTION AND ANALYSIS

75

COLLECTION AND ANALYSIS

OF RELATED DATA IS AN OF RELATED DATA IS AN

ESSENTIAL COMPONENT OF

ALL EFFECTIVE RISK

MANAGEMENT PLANS

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Continuous Measurementof Risk Management Dataof Risk Management Data

Occurrence reporting

76

Performance measures

Quality and utilization management screening

Surveillance, audits, and surveys

External review data/denials

Patient satisfaction/dissatisfaction and complaints/grievances

Financial audits and billing disputes (primarily financial but can overlap with clinical)

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Continuous Measurementof Risk Management Dataof Risk Management Data

Root Cause Analyses (RCA), Failure Mode and Effect Analyses , special studies

77

Grapevine information system and anonymous reporting

Physician/nurse referrals

Safety and other committees

Observation of daily operations and care

R i f Review of contracts

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Making the Data MEANINGFUL78

Analyze all data in a variety of relationships and perspectives to identify t d iktrends or spikes

Utilize PDSA’s or other improvement initiatives (start small and do pilots initiatives (start small and do pilots first) to address trends before they become big problems.become big problems.

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Other Significant RM Data

Review:

79

Review:• Any recent or current liability claims

C h ti t’ di l d • Cases where patient’s medical records are requested

• Case types identified through literature review, Case types identified through literature review, news media, or new state or federal law

• Practices that may create liability• ALL occurrence or incident reports

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OCCURRENCE Vs. INCIDENT?

Occurrence Reporting uses generic screening to

80

p g g gcatch APOs. RM determines which APOs may be PCEs • Supports ongoing data collection, tracking, trending, and

analysisanalysis• Allows timely intervention• Allows identification of areas for preventive action

Incident Reporting is the oldest method of risk identification and analyzing loss potential

Is largely anecdotal• Is largely anecdotal• Is an internal source for actual or potential compensable

events• Is historically an administrative documentation system • Is historically an administrative documentation system

and is generally considered “discoverable”

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Occurrence/Incident ReportTracking and Analysis

Set up an organizational system for

81

Set up an organizational system for tracking occurrences

According to service line• According to service line• According to problem or cause, or type of problem or

cause• Is advantageous to categorize in multiple ways to ensure

accurate tracking (systems, processes, time, place)• Use this as a tool to track and trend systems problems or y p

issues in certain services• Include categories for equipment problems and

medication problems, and ensure appropriate follow upp , pp p p

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National Patient Safety Foundation

82

E N C O U R A G E S A L L W O R K E R S T O A C C E P T

R E S P O N S I B I L I T Y F O R T H E S A F E T Y O F

T H E M S E L V E S T H E I R C O W O R K E R S T H E M S E L V E S , T H E I R C O W O R K E R S ,

P A T I E N T S A N D V I S I T O R S

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BREAK TIME / INTERMISSION83

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COMMUNICATION

Insurance claims administrators and medical 84

Insurance claims administrators and medical liability defense attorneys estimate that communication failure is a contributing factor in 80% of all professional claims and lawsuitsof all professional claims and lawsuits

In 20% of the cases, it is the primary reason for the filing of the lawsuit.

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Provider Communication

J O I N T C O M M I S S I O N H A S B U I L T S E V E R A L

85

J O I N T C O M M I S S I O N H A S B U I L T S E V E R A L S T R A T E G I E S T O I M P R O V E

P R O V I D E R C O M M U N I C A T I O N

I N T O

N A T I O N A L P A T I E N T S A F E T Y G O A L S

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E4 Component of Clinical Care

1) ENGAGEMENT

86

)Greet by name with patient fully clothed (both the patient and the provider)

Be curious about the personBe curious about the person

Learn person’s agenda, including goals and all complaints

2) EMPATHYValidate expressed fears, concerns, symptoms, and pain

Sit, maintain eye contact, remove physically barriers

Learn to have open and relaxed body language

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E4 Component of Clinical Care

3) EDUCATE – about the encounter, diagnosis, etiology,

87

treatment options and follow upAssess current knowledge

Assume there will be questionsAssume there will be questions

Reassure patients that there will be time available for them to ask questions

E ti t d t d i f ti id d b ki th t Ensure patient understands information provided by asking them to restate

4) ENLISTMENT –Invitation to patient to collaborate in decision making and compliance.

Many patients have a self diagnosis. Provide rationale for yoursy p g y

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ANGRY or DIFFICULT?

88

THIS IS NOT A TYPE OF PATIENT, BUT

A CLINICIAN EXPERIENCE. (SORRY…)

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The experience is based on interaction between the patient and the provider

Difficulties stem from frustrations (either

89

Difficulties stem from frustrations (either party), inflexibility, and misaligned expectationsexpectations

• Be aware that anger is expressed both verbally and non-verballynon verbally

• Acknowledge the patient’s anger or dissatisfaction.• Establish the goal to assist him or her in expressing

d l i i h b ibl and resolving concerns in the best possible manner• Allow the patient to express her/his anger in a

private area, away from other patients.p ate a ea, a ay o ot e pat e ts.

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Frustrating or Difficult Visits(continued)

Demonstrate empathy

90

Demonstrate empathy

Focus on content rather than delivery of patient’s message

Use self disclosure cautiously and when appropriate

After the patient has vented, respond by talking about those issues that can be readily resolved

Enlist patient in the problem solving and get his/her input before Enlist patient in the problem solving and get his/her input before determining plan of action

DOCUMENT EVERYTHING, omit nothing.

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How to Handle an Adverse Outcome or Potential Adverse Event

COMMUNICATION is an essential liability

91

yavoidance measure

DISCLOSURE is core in management of clinical crises, adverse outcomes, unanticipated events,

di l d di l i hmedical errors, and medical mishaps

F i h ld bli h d For consistency, centers should establish and use similar terms and nomenclature for DISCLOSURE

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DISCLOSURE METHODS

DISCLOSURE MODELSOne person (RM or QI)

DISCLOSURE STRATEGIES

92

One person (RM or QI)

Team Model (RM, Manager, Key Staff involved)

J i Ti Di l

STRATEGIESAcknowledgement that the event occurred

C i ti f tJust in Time – Disclose at the point of care or adverse event. This is the ideal model

Communication of regret

An apology

Objective statementsthe ideal model (transparency)

What occurred

Event is being investigated

Steps will be taken to avoid precurrence

Remain in close contact with pt. and family till resolvedp y

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“Best Practice” Communication93

Failure to communicate effectively is responsible for the vast majority of avoidable accidents

Replace top down communication with bi-directional i icommunication

A majority of healthcare workers regularly see colleagues break rules, make mistakes, fail to offer support, and/or appear critically incompetent. LESS THAN 20% SAY ANYTHING ABOUT IT!ABOUT IT!

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How to Implement a pReliable and Consistent

Occurrence Reporting System

O R

94

O R ,

“ P L E A S E D O N ’ T F I R E T H E M E S S E N G E R !

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MYTHS that PREVENTOCCURRENCE REPORTINGOCCURRENCE REPORTING

“If I can make it right it’s not an error ”

95

If I can make it right, it s not an error.

“If it’s not my issue it is not an error ”If it s not my issue, it is not an error.

“If another patient’s needs took priority over this, it is not an error ”error.

“A ‘Clerical’ (documentation) error is not a real med error.”

“If my actions prevent something worse, it is not an error.”

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C ti “JUST CULTURE f Creating a “JUST CULTURE of Safety”

“ T H E M E D I C A L C U L T U R E T H A T S I L E N T L Y T A U G H T

y96

“ T H E M E D I C A L C U L T U R E T H A T S I L E N T L Y T A U G H T

T H E A B C ’ S A S A C C U S E , B L A M E A N D C R I T I C I Z E I S

F A D I N G . R I S I N G I N I T S P L A C E I S A S A F E T Y

C U L T U R E E M P H A S I Z I N G B L A M E L E S S R E P O R T I N G ,

S U C C E S S F U L S Y S T E M S , K N O W L E D G E , R E S P E C T ,

C O N F I D E N T I A L I T Y , A N D T R U S T . ”

D R . T O M H E L L M I C H O F P A T I E N T S A F E T Y C O U N C I L

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For Decades, Occurrence Reports Often Ledto Termination

Staff were afraid to report errors or near misses for

97

errors or near misses for fear of repercussions to themselves or their co-workers.

If asked to fill one out by a i t ff f lt lik supervisor, staff felt like

there was automatic blame placed on the one pwho wrote or reported it.

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Transition from Punitive Responseto “Blameless” Reporting

There was an interim period in the late 80’s and 90’s

98

p 9termed a “non-punitive culture.” This raised concerns that people who acted recklessly would not be held

t bl Whil l d hi t lk d “ iti ” accountable. While leadership talked “non-punitive,” occurrence reporting continued to be avoided by many employees fearing repercussions and blame for employees fearing repercussions and blame for reporting errors.

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Creating the “JUST CULTURE” in Healthcare

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Lucien Leape, Harvard surgeon, father of recent patient safety movement, introduced the “just culture”… “Having a safety culture doesn’t mean there is no role for punishment. Punishment is indicated for willful misconduct reckless behavior indicated for willful misconduct, reckless behavior, and unjustified, deliberate violation of rules… but not for human error.”

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More on the “JUST CULTURE”David Marx, Attorney in HR and Organizational Development

Providers and Leaders in a ‘just culture’ must:

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Providers and Leaders in a just culture must:• Recognize that professionals make mistakes• Acknowledge that even professionals will use shortcutsg p• Support zero tolerance for reckless behaviors• Openly admit that, “I have made a mistake.”• Call out when they see risk• Call out when they see risk• Participate in a learning culture (where information about

mistakes and near misses is shared with others so they can prevent similar situations )prevent similar situations.)

• Must be sensitive to risk, as they try to identify where and how the next mistake might occur, and then work to prevent it form happeningit form happening.

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“SILENCE KILLS: THE SEVEN CRUCIALCONVERSATIONS IN HEALTHCARE”CONVERSATIONS IN HEALTHCARE

Book by Stacy Nelson, EdD: Referenced by Joint Commission recommendations—

il kill

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www.silencekills.com

This book and the study it details is the first attempt to This book and the study it details is the first attempt to link people’s ability to discuss emotionally and politically risky topics in a healthcare setting with ke es lts inkey results in:

Patient safety

Quality of careQuality of care

Decreased turnover in nursing

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This study identifies SEVEN categories of conversation which areof conversation which are…

especially difficult and at the same

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…especially difficult, and at the same time appear to be especially essentialfor people in healthcare to master:for people in healthcare to master:• Broken rules

Mistakes• Mistakes• Lack of support• Incompetence• Incompetence• Poor teamwork• Disrespectp• Micromanagement

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Benefits of “Tough” Conversations

The study shows that the 10% of healthcare workers

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The study shows that the 10% of healthcare workers who are confident in their ability to raise those “sensitive” concerns:

• Experience better patient outcomes• Work harder

A ti fi d• Are more satisfied• And are more committed to their jobs

A primary goal for healthcare leaders is to create an A primary goal for healthcare leaders is to create an environment that encourages open discussion and transparency in these sensitive conversations.

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Suggestions for Leadership to EncourageOpenness in “Sensitive” TopicsOpenness in Sensitive Topics

“Have you observed any actions or omissions that could have

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Have you observed any actions or omissions that could have caused patient harm but didn’t? Tell me about it.”

“Do you feel comfortable speaking to other care providers if you feel they are jeopardizing patient safety? Do you feel comfortable reporting lapses you observe in patient safety? Why or why not?”

“Can you tell me about a time when a patient was harmed? Tell me how you think that happened and your ideas on how we could prevent it from happening again ”prevent it from happening again.

Occurrences may appear to increase at first, but that is due to more honest and realistic reporting of actual and potential to more honest and realistic reporting of actual and potential adverse events.

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Leaders in Risk Management

Change Agent:

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Change Agent: • Uses PI processes for & in RM and RM processes for &

in PIin PI• Part of PI team: identifies RM and safety related issues

in PI projects and points them out constructivelyE hi th t ’ l ti • Encourages researching other centers’ solutions; frequently uses PDSA’s

• Actively opens up “silo” mentality in center or organization

• Uses a team-based model with all stakeholders involved in solutions, including patients when possibleo ed so ut o s, c ud g pat e ts e poss b e

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Leaders in Risk Management

Prioritize and advocate for safety above financial and

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yoperational goals

Encourage and reward identification, communication, and l ti f f t iresolution of safety issues

Provide for organizational learning from accidentsg g

Allocate appropriate resources, structure, and accountability to maintain safety systemsmaintain safety systems

Absolutely avoid modeling reckless behavior in any form or in management decisionsmanagement decisions

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Leadership Pitfalls107

B

Leadership Pitfalls

• Beware of introducing a NEW BE

• Beware of introducing a NEW risk by implementing a solution whose implications h t b f ll d W

A

have not been fully assessed.

• Do not change a process based AR

• Do not change a process based on one disastrous occurrence, without assessing a “special

i i ”E

cause variation.”

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High Quality Care is Safe Care108

Remember, it’s really all about

idi f providing safe, quality care for our

patientspatients.

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109

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Any questions, please feel free to call or write:p

110

Becky Simer, RN [email protected]

Linda Ruble, PA [email protected]@ianepca.com

(W)515-333-5014(C) 515-868-8458

[email protected](H) 515-255-4147(C) 515-778-3318 (Never

ll h d i i t answers cell when driving – a part of her personal risk management plan!)

THANK YOU!!!