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Copyright JCAHO 2001 1

PenchunSaenprasarn

Copyright JCAHO 2001 2

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Overall Req.

Multiple Req.

II 8 1.2 ��������������� �� ���������� ���������(Risk, Safety, and Quality Management System)

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Copyright JCAHO 2001 4

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Copyright JCAHO 2001 5

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� 4��%&� �* 4 (���A�&)!"���,�,�����A�&��$�? ' �����'('�'�>6?���%4FA#��$������%,'9�.&�9"� A����9�%:�-?������9#A�� %$8*�%(F'6�"%,''�>��$��,�,�����A�&4����.4�+(.� �%4�:��9:(�8�6?A��(��:��4��%&� �*4(��.) ��A ' �*%�8*�(� ��� ���(�8�%������+(;?���B�.�#���H��4��%&� �*4 (���A�&) $�9"+,���$��$ "��� �����%,'���A�&6?$���,�,��� '�<�$���$��- �.&��/�����0 4��%&� �* 4(���A�&)4<�$����$6�"4�����$I��

Copyright JCAHO 2001 6

� �� "6&& �B : the 5 “Ds”

DeathDiseaseDisabilityDiscomfort

Dissatisfaction

Copyright JCAHO 2001 7

� Patient Safety "#$%&()*$+,-./0+1,234$5"1673$+,-./0+1,8+8#$:;8/6=1++1,.1&>=?. +1,>@A46$B)6 5,C#+1,@;D>@A6 (A4>+E&F3*0,-5/1$+1,&;HI,)+J1 234$K/1"8I#&B)6F#$:;8/6L#$+1,,-..HI-+,-./0+1,(A48ME.)LE%&N0+1,8#$+)0>5LO+1,P%"R3$8,-@$K

� N0>SE$:II)RT K/1"8I#&B)6F#$:;8/65"1673$ +1,8,1U=1+#)0L,16(A4>+E&=1+#O.)LE>5LO,-5/1$>F1,).+1,.,E+1,@OB1R5,C#@B1/-+1,8,1U=1+B)6 #)0L,16 +1,.1&>=?. +1,>@A46$B)6 5,C#+1,@;D>@A6(A4=-+#N5>+E&+1,.1&>=?.L#:;8/6 K/1">@A6516L#(,)R6@E0

Copyright JCAHO 2001 8

- %(�7���09$�<�#��-�� (adverse event-AE) ��������������:����� �!"� #$��%&�'%$ (�)*+���,�#� �'%$���-�./0�123�*425�#6��7 ,1�2�38���!����� 9+����:� /&. ���& !��;�5�9�3<)=@/0N5D>+E&=1+K/1":E&RI1&N0+1,&;HI,)+J1 (medical errors)80% >+E&=1+K/1":E&RI1&F#$"0OJ6 K/1"I">5I/N0+1,L)&@E0N=@$:I:E&RI1&

- ������ (error) : ����C�2���������=2���.3!�����)�2+�� '�6#���%�D2E!.)�'�6#����C�2��E 7���./0����$����������%�#2��� #�!!*��& !��%�D2E!+�*./0%�D2E!

Copyright JCAHO 2001 9

� ����� �������������������������� ���� �� 2 � �!�� "����#

� +1,H+8D51>SE$.OKKI (person approach)� +1,H+8D51>SE$,-.. (System approach)

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Copyright JCAHO 2001 10

,��!(�:����AA���T %��"4�� 2 #44 �� K/1"I">5I/=,E$ (active failures) +1,+,-(\1%"8I#&B)6 `&6:;N5.,E+1,`&6L,$ >S0 K/1"RI)*$>:I#, :E&RI1& b0+^,->.A6.

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Copyright JCAHO 2001 11

����� �* 1 4��'�':����%���'%�8*�����"?.&� �����(���# �.3. 2539 - 2543

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Copyright JCAHO 2001 12

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Copyright JCAHO 2001 13

��S ��T�T�����

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Copyright JCAHO 2001 14

�%��L�'�KQU T�Q�����" ��S L�V��� T� �Q�

�%�%' �W������ '�KQ��!���� � "���T�Q��X �� � 'I

Copyright JCAHO 2001 15

�Y! ���"ZQ���%�� %���� ��V� ��ZQ�����

Z!�T�Q�[M��%'�!��Z!�T�Q�[M��%'�!�� ��I�������"�� ���I�������"�� �

I�" near miss I�"�����X miss

Copyright JCAHO 2001 16

� Do Right Things� Do Them Well� Better Chance for Good Outcomes.

Accreditation Represents a Risk Reduction Strategy

Copyright JCAHO 2001 17

WHO WHO World Alliance World Alliance for Patient for Patient SafetySafetyto address the problem of to address the problem of

patient safety worldwidepatient safety worldwide

Copyright JCAHO 2001 18

� The problem of adverse events in health care is serious� 10% of hospital patients suffer an adverse event each year (UK, New Zealand, Canada and Europe)

� 16.6% of hospital patients suffer an adverse event (Australian study)

� 98,000 hospital deaths every year through medical error (USA)

� 1.4 million hospital patients worldwide acquire HAI (at any given time)

� UK: 100,000 cases of HAI lead to 5,000 deaths a year� USA: 1 out of every 135 hospital patients acquires HAI

Copyright JCAHO 2001 19

“Human beings make mistakes because the

systems, tasks and processes they work in

are poorly designed.”

Dr Lucian Leape, testifying to the US President’s Commissionon Consumer Protection and Quality in Health

Copyright JCAHO 2001 20

The Ubiquitous Patient Safety Challenge

• Denial and cover-up remains common• Systems awareness is limited and the capability to re-design systems to be safer is growing but still limited

• Health care is dynamic and ever changing with new drugs, technology and chronic diseases

Copyright JCAHO 2001 21

World Health Assembly Resolution 55.18• Develop global norms and guidance• Promote evidence-based policies• Encourage patient safety research• Share best practices• Promote cultures of safety in health care organizations

Copyright JCAHO 2001 22

Overview of the Alliance� The Alliance was set up to support countries improve their

safety of care� The Alliance:

� Generates awareness and commitment: political, clinical, patient

� Engages global and regional partners: private, public, NGO

� Develops and shares knowledge: guidelines, standards, research data, solutions, reporting & learning

� Provides technical expertise to countries� Mobilises resources to implement country projects

Copyright JCAHO 2001 23

World Alliance on Patient Safety Strands• Global Patient Safety Challenge• Patients for Patient Safety• International Patient Safety Events Taxonomy

• Reporting Systems• Research• Dissemination of Patient Safety Solutions

Copyright JCAHO 2001 24

First Global Patient Safety Challenge

Copyright JCAHO 2001 25

The Global Challenge: Clean Care is Safe Care

• Overarching strategy• Focus on hand hygiene• Comprehensive Guidelines on Hand Hygiene

Copyright JCAHO 2001 26

Patients

Copyright JCAHO 2001 27

Harvard Practice

Medical Study

1984

Utah Colorado

Study 1992

Australian Quality in Healthcare Study 1992

Adverse events in British Hospitals

1999-2001

Danish Adverse Event Study

2001

Adverse Events in New Zealand Study 2002

Canadian Adverse Event Study

2004

French Adverse Event Study

2004

The Commonwealth Fund Survey

2005

Research for Patient Safety

Copyright JCAHO 2001 28

Research• Project on measuring patient harm in data-poor environments

• Development of international patient safety research agenda

• Candidate studies• Funding issues

Copyright JCAHO 2001 29

Solutions for Patient Safety

30

Errors and adverse events can result from a variety of issues atErrors and adverse events can result from a variety of issues at different levels different levels

within health carewithin health care——for example, at the level of government support (e.g. funding), for example, at the level of government support (e.g. funding),

the level of a healththe level of a health--care facility or system (e.g. structure or processes), or at thecare facility or system (e.g. structure or processes), or at the

point of intervention between patients and practitioners (e.g. hpoint of intervention between patients and practitioners (e.g. human error). The uman error). The

Solutions from this initiative will not address the broad underlSolutions from this initiative will not address the broad underlying causes of ying causes of

patient safety problems (e.g. inadequate resources), but rather patient safety problems (e.g. inadequate resources), but rather will be directed at will be directed at

the specific level where good process design can prevent (potentthe specific level where good process design can prevent (potential) human ial) human

errors from actually reaching the patient. Solutions, therefore,errors from actually reaching the patient. Solutions, therefore, will be intended to will be intended to

promote an environment and support systems that minimize the rispromote an environment and support systems that minimize the risk of harm k of harm despite the complexity and lack of standardization in modern headespite the complexity and lack of standardization in modern health care.lth care.

Copyright JCAHO 2001 31

Confusing drug namesConfusing drug names is one of the most common causes of is one of the most common causes of

medication errors and is a worldwide concern. With tens of medication errors and is a worldwide concern. With tens of

thousands of drugs currently on the market, the potential for erthousands of drugs currently on the market, the potential for error ror

created by confusing brand or generic drug names and created by confusing brand or generic drug names and

packagingpackaging is significant. The recommendations focus on using is significant. The recommendations focus on using

protocols to reduce risks and ensuring prescription legibility oprotocols to reduce risks and ensuring prescription legibility or the r the use of preprinted orders or electronic prescribing.use of preprinted orders or electronic prescribing.

Copyright JCAHO 2001 32

The widespread and continuing failures to correctly identify patThe widespread and continuing failures to correctly identify patients ients

often leads to medication, transfusion and testing errors; wrongoften leads to medication, transfusion and testing errors; wrong person person

procedures; and the discharge of infants to the wrong families. procedures; and the discharge of infants to the wrong families. The The

recommendations place emphasis on methods for verifying patient recommendations place emphasis on methods for verifying patient

identity, including patient involvement in this process; standaridentity, including patient involvement in this process; standardization of dization of

identification methods across hospitals in a health care system;identification methods across hospitals in a health care system; and and

patient participation in this confirmation; and use of protocolspatient participation in this confirmation; and use of protocols for for distinguishing the identity of patients with the same name.distinguishing the identity of patients with the same name.

Copyright JCAHO 2001 33

Gaps in handGaps in hand--over (or handover (or hand--off) communication between patient care off) communication between patient care

units, and between and among care teams, can cause serious units, and between and among care teams, can cause serious

breakdowns in the continuity of care, inappropriate treatment, abreakdowns in the continuity of care, inappropriate treatment, and nd

potential harm for the patient. The recommendations for improvipotential harm for the patient. The recommendations for improving ng

patient handpatient hand--oversovers include using protocols for communicating critical include using protocols for communicating critical

information; providing opportunities for practitioners to ask aninformation; providing opportunities for practitioners to ask and resolve d resolve

questions during the handquestions during the hand--over; and involving patients and families in the over; and involving patients and families in the handhand--over process. over process.

Copyright JCAHO 2001 34

Considered totally preventable, cases of wrong procedure or wrong site surgery are largely the result of miscommunication and unavailable, or

incorrect, information. A major contributing factor to these types of errors is the lack of a standardized preoperative process. The

recommendations to prevent these types of errors rely on the conduct of a preoperative verification process; marking of the operative site by the practitioner who will do the procedure; and having the team involved in

the procedure take a “time out” immediately before starting the procedure to confirm patient identity, procedure, and operative site.

Copyright JCAHO 2001 35

While all drugs, biologics, vaccines and contrast media have a While all drugs, biologics, vaccines and contrast media have a

defined risk profile, concentrated electrolyte solutions that ardefined risk profile, concentrated electrolyte solutions that are used e used

for injection are especially dangerous. The recommendations for injection are especially dangerous. The recommendations

address standardization of the dosing, units of measure and address standardization of the dosing, units of measure and

terminology; and prevention of mixterminology; and prevention of mix--ups of specific concentrated ups of specific concentrated electrolyte solutions. electrolyte solutions.

Copyright JCAHO 2001 36

Medication errors occur most commonly at transitions. MedicatioMedication errors occur most commonly at transitions. Medication n

reconciliation is a process designed to prevent medication errorreconciliation is a process designed to prevent medication errors at patient s at patient

transition points.transition points. The recommendations address creation of the most The recommendations address creation of the most

complete and accurate list of all medications the patient is curcomplete and accurate list of all medications the patient is currently takingrently taking——also called the also called the ““homehome”” medication listmedication list;; comparison of the list against the comparison of the list against the

admission, transfer and/or discharge orders when writing medicatadmission, transfer and/or discharge orders when writing medication ordersion orders;;

and communication of the list to the next provider of care wheneand communication of the list to the next provider of care whenever the ver the patient is transferred or discharged.patient is transferred or discharged.

Copyright JCAHO 2001 37

The design of tubing, catheters, and syringes currently in use iThe design of tubing, catheters, and syringes currently in use is s

such that it is possible to inadvertently cause patient harm thrsuch that it is possible to inadvertently cause patient harm through ough

connecting the wrong syringes and tubing and then delivering connecting the wrong syringes and tubing and then delivering

medication or fluids through an unintended wrong route.medication or fluids through an unintended wrong route. The The

recommendations address the need for meticulous attention to recommendations address the need for meticulous attention to

detail when administering medications and feedings (i.e., the ridetail when administering medications and feedings (i.e., the right ght

route of administration), and when connecting devices to patientroute of administration), and when connecting devices to patients s (i.e., using the right connection/tubing).(i.e., using the right connection/tubing).

Copyright JCAHO 2001 38

One of the biggest global concerns is the spread of Human Immunodeficiency Virus (HIV), the Hepatitis B Virus (HBV), and the

Hepatitis C Virus (HCV) because of the reuse of injection needles. The recommendations address the need for prohibitions on

the reuse of needles at health care facilities; periodic training of practitioners and other health care workers regarding infection control principles; education of patients and families regarding transmission of

blood borne pathogens; and safe needle disposal practices.

Copyright JCAHO 2001 39

One of the biggest global concerns is the spread of Human Immunodeficiency Virus (HIV), the Hepatitis B Virus (HBV), and the

Hepatitis C Virus (HCV) because of the reuse of injection needles. The recommendations address the need for prohibitions on

the reuse of needles at health care facilities; periodic training of practitioners and other health care workers regarding infection control principles; education of patients and families regarding transmission of

blood borne pathogens; and safe needle disposal practices.

Copyright JCAHO 2001 40

Solutions in Development

1. Preventing Patient Falls2. Preventing Pressure Ulcers3. Look-Alike Packaging and Labeling of

Medications4. Response to the Deteriorating Patient5. Communicating Critical Test Results6. Healthcare-Associated Infections:

Central Lines7. Apology and Disclosure8. Patient and Family Involvement

Copyright JCAHO 2001 41

������������������� ���

Risk Identification Risk assessment

Risk TreatmentRisk evaluation

Wilson + Tingle 1999

Copyright JCAHO 2001 42

� �������� ��-+,�#�!�����%-�����!���-!!����-./������0�& ���� �

���������� �� ���������� ��-������ ��-�/�����-1"��*��-��"����-������(2������!"�����)�)�

�����'�����

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��������������������������������� RM:05

Copyright JCAHO 2001 43

Copyright JCAHO 2001 44

Copyright JCAHO 2001 45

������4������5���#��� Jo. Wilson,1999, P 31.

������Screening

��=>�� Assessing

����� Planning

�5�� Caring

��=>�� ��Evaluation

�5��F��/��H�Patient

Nursing* Medical Paramedical

Support*Services

Hotel*Services

Management*Services

Copyright JCAHO 2001 46

������������������ ( (Service)Service)

����(������(�� ( (Care)Care)

������#�������#�

(Treatment)(Treatment)

Copyright JCAHO 2001 47

RMRMQAQA

CQICQI

Average ExcellenceBorderline

QUALITY OF CARE

ZONE OF QUALITY MANAGEMENT

# O

F H

OS

PIT

AL

SThe Total Quality Spectrum

lkdgf

�������&��������0��) �� %"��� ������������&��������0��) �� %"��� �����

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Copyright JCAHO 2001 48

Customer

Driven

Copyright JCAHO 2001 49

• ����� ����� *������ !���������

- ������!9�/������

- �%�� ��

- ���%���

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- ��� Expose

• �����&������� ��

- ������ ����; ���� !�%��22��

����� �������0�

Copyright JCAHO 2001 50

������������� ���������������� ��� � ������� ������ �����������������������������������

�� !�"� FMEA �'�(���)�����*+����),���������"�������� !+"��

!���� ����-��������� �� ������������. -���*+����),���*�"������/�� *�/����0����������--��'�(* ��������1��23��

� ����'� Clinical CQI

� ������0 � RCA �/�����������*,*����*+���� �'���/������

�*+����),������!�� *�/�����0"������� �2/����0�����00!3����0��������=�2��0�3 ������1. ���������� ��

Copyright JCAHO 2001 51

���������������� ���������������

��������������� Risk Monitoring

Risk Reassessment �����������#%��&���'(��(����������#%�� )����$* ���������� �(�������#%������+ ��*�,�����#%��$#%������-(.���/��01��(#���(.�

Status Meeting �/��$#�����������&����#%������*���2 �01��(�����

Risk Audit�/�������3�(*������������-(&)�$#%���.���#�����$"�)�4#����(�33�(�,���&)� ��-((�33�$���-%(�#����*�01���,�����$#%�(���*.��

Variance Analysis

Trend Analysis

���3�(*���&�������������&)�&����%�$#%�5�*���3���: (�33��/���������� �*�����2 �27�4 ��-('(*'�'(����

��#�*$#�*)������������� over time &��4����2 )���(���

Reserve Analysis ��#�*$#�*$��4����$#%����(�.��3�������*����#%�� ��*����#%��$#%�����-((�,�

http://www.anticlue.net

Copyright JCAHO 2001 52

���������������� ���������������Areas of Risk / Patient Safety

to be Monitored

General

Adverse Events

Mortality: Risk Adjusted, Standardized, Case Specific Fatality

SpecificHospital Associated Infection

Surgery & Anesthesia

Medication & Transfusion

By Services: ER, ICU, Maternal & Neonatal

High Risk Patients & Procedures

Environment & Equipment

Patient’s right, Ethic

Copyright JCAHO 2001 53

���������������� ���������������

Adverse Event & Error

Error (��� !�"��#�) �%�&��������������� &����%�&'(��������') ����*"�Adverse Event (&+,�����-���* %�.�'�����-) �%�&���������� ��,���

���&��"/.#����!0�'1�� &'(���� �%�&������!���-

ErrorAdverse

Event

Copyright JCAHO 2001 54

����� ����<�=����"�����������

1. P#�>P������>����4�#���������Q�>�R � ��!�S���!��� 2. ��=H�� ���>������PTS�P��!�S>�U�>���=��#�� ��� �� !����

��=�5��F��>�TS������ H�=� �H#���������Q�3. >P������V���������W�V#� ��=��!��������>P�S��

>�TS���������Q�4. 4�P��!������>�TS���������Q�5. ��������5�V������> � ��������Q�

Pronovost 2004 P. 59 - 68

Copyright JCAHO 2001 55

RM QA CQI is Power� �709"$����"��%'�'����'(����$%-�*��+, / 9$+,

� :0� �*�70 ����'+,$���s�'� +, / 9$+,

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Copyright JCAHO 2001 56

71K\1L#.F#$KOPKC# NS

�����A:���709".-"� +(%(F'�� �709"'��%��(& ����A������:��QA RM CQI$�+,.�#t(�+',����#��4��� '%���A���.&�

Copyright JCAHO 2001 57

RCA ANALYSIS

To get results, should we focus our behavior on the Y or X ?

“���������� X �� ���������������� Y ?”3.Analyze

4.Improve

���� Y

���� Dependent

���� Output

���� Effect

���� Symptom

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Y=1.Define

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(�������)

f (X)

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Copyright JCAHO 2001 58

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�.�. �.�. ��.�. ��.�. �.�. �.� �.�. .�. �.�. �.�. �.�. �.�.

CQI

P Systemic Link Chart (Moor)Y = f( x1 +x2 +x3……xn)

������/��������*�"��RM/CQI/QA

X=CQIx13 ���/�x2�.����*�x33 �����

CY=VAP

Copyright JCAHO 2001 59

$�(�$��)*��+��,-���������*������!����������� �"��0������-2��

I ���-2�� 1. �-2��/ !���"�� ? (*������!�����0�)

II %�$��/� 2. %��)�$�����������2����(�� ?

III ./��( 3. ���0� ���� �����0"? ����������(��!����?

��"��0�?

4. �����%������"� �9�& �(�����9����%�

Copyright JCAHO 2001 60

$�(�$��)*��+��,- (���)IV ������� �� 5. ��"���� )"������� 0&�-2�� ������

�G#H�/ ��!�� 3 �� ��

6. �������������� 0& (����)

Y=f(X1 X2 X3……XN)

7. ������K���%�

8. ���'������� 0&

9. ���������'����=;

10. &���'�*���������O��("���K���%��%�P��

Copyright JCAHO 2001 61

.'���"Root Cause Analysis (RCA)%#'����'(�#44 � �*%#'���:��#t(� (�8�-�%(�7�8>'s�':�����$.#�#��'+'���#H�A ����' ��$9#;<�-�%(�7:�����%��"�7A �����0 (�8�%(�7���0 �*9$�<�#��-�� �*�7'.��

62

Complying with the FMEA Requirements of the New Patient Safety Standards

Darryl S. Rich, Pharm.D., M.B.A., FASHP

Associate Director, Surveyor Development and ManagementJoint Commission

Copyright JCAHO 2001 63

New Patient Safety Standards

� It’s a leadership thing!� Manage variation in performance� Integrated patient safety program implemented

� Ongoing proactive program to identify risks to patient safety and reducing errors

� Patient safety is a high priority

Copyright JCAHO 2001 64

LD.5.2

� Leaders ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented.

Copyright JCAHO 2001 65

Requirements of LD.5.2

� At least annually, select at least one high-risk process for proactive risk assessment � such selection to be based, in part, on information published periodically by the Joint Commission that identifies the most frequently occurring types of sentinel events and patient safety risk factors

Copyright JCAHO 2001 66

High Risk Processes� PI.4.2 – Processes that involve risks or may result in sentinel events� Medication Use� Operative and other procedures� Use of blood and blood components� Restraint use� Seclusion, when a part of care� Care/services provided to high-risk populations� Resuscitation

Copyright JCAHO 2001 67

The Medication Use Process

Selection, Procurement, and Storage

Prescribing or Ordering, and Transcribing

Preparing and Dispensing

AdministrationMonitoring

Copyright JCAHO 2001 68

Requirements of LD.5.2

� Conduct a Failure Mode and Effects Analysis (FMEA)� Assess the intended and actual implementation of the process to identify the steps in the process where there is, or may be, undesirable variation (i.e., what engineers call potential "failure modes")

Copyright JCAHO 2001 69

RCA RCA RCA RCA ���� is a is a is a is a process,usually process,usually process,usually process,usually

reactive ,for identifying thereactive ,for identifying thereactive ,for identifying thereactive ,for identifying the

basic or causal factors that basic or causal factors that basic or causal factors that basic or causal factors that

underline variation in underline variation in underline variation in underline variation in

performance and which performance and which performance and which performance and which

can produce unexpected can produce unexpected can produce unexpected can produce unexpected

and and and and undesired adverse undesired adverse undesired adverse undesired adverse outcomes.outcomes.outcomes.outcomes.

70

Failure Mode and Effect Analysis

Copyright JCAHO 2001 71

Failure Mode and Effect Analysis

� ����������;���� �������& �����"�� ���'�������� !����&,$� Q, ��O���� ������ !�)"���������������"���O����� ��������� )�$�"� ������!�����%�&��& �����"���� ����*� �"�!����&,$�

Copyright JCAHO 2001 72

Failure :

���� ��� & �����"��&������ ������������������ ������������� ������� !������������ �O�0�%�& �������*��& ���������$�O�'��!������������; ��������'����!���O� ���% ����� �������������&���(�� �

Failure Mode: ����=����)��������

���#��&��& �����"���� ���&,$�(Failure))"����� �%� *�"� ��&���*%���0� ���� '�� ��& ���0�

����=����)�����������

���#��& �����"���� ���!����������� )"����%�����'������ ���!"����'������

Effect:'�&��& �����"���� �%"� ���� ���������1��0� ������ �� ��& �� '��%���R;���������� �(�� ������� ����(�� ������

Copyright JCAHO 2001 73

!���"����&��FMEA

� �����1,����*� &��& �����"���� ��!���&,$� ������%�&��& �����"����$�S

� �"�)�$1,������ 0&������� !����!��������*������������& �����"��

� �O�����������!��� �������<��'��%���R; ��������������"���O�����

Copyright JCAHO 2001 74

���������%;�) FMEA

� � ������� ������" '��%���R;��" ��������"��������������� ������0� ������������

� � �������� ������ ��������� '��%���R; ����������� � �'��%���R;�������������0� 1(����0��) ����� ����� �������=������ ��� �%�%"��!����%�

� ����!������� 0&�-2����9!��$� ����) �� ��/�����0"�� �-2�������"�����&,$����

� � �% ������������%�����/����������������������� �����("���-!!����

Copyright JCAHO 2001 75

��������� FMEA�� �������=����

� �O�������������& �������(Multi-disciplinary Teams)

� ��)��5-9 �� %������� �!���%"����"�����% ���O�'( ����������;%����#������� !��������������; �������1)�2��������;��& ��"��O���)��)� �����0�

� ���%1�������;����/������ )��!�

� ��)������ �����"��� ����) ���&���� �������� ������;

Copyright JCAHO 2001 76

FMEA Process Sequence

RPN

Detect

Occur

Sev

Actions Taken

12

Action Results 13Responsibility&Target Completion Date

11

Recommended Action(s)

10

RPN

9

Detec

8

Current Controls

7

Occur

6

Potential Cause(s) of Failure

5

Sev

4

Potential Effect(s) of Failure

3

Potential Failure Mode

2

Activity

1

Copyright JCAHO 2001 77

FMEA Basic Steps

1. ����1,��������������&�$�%���� % �����+,�#�(Flow chart)2. ����& �����"���� ��!!����&,$�(Potential Failure Mode)3. ����'�������� ��!!����&,$�(Potential Effects of

Failure)4. & �����"�������"���'������%"��� ��� ���������������������"

0��(Severity)5. ��0��O����%��� �O�0�0� �� ����� ���& �����"�� (Potential

Causes)6. *������������& �����"������ ������0�(Occurrence)7. ��=������ �) ����������& �����"�����-!!����(Current

Controls)8. �������1��������������%��!!��& �����"��(Detection)

Copyright JCAHO 2001 78

FMEA Basic Steps

9. ��������������� ���� ��!!����&,$�(Risk Priority Number)

10. ������������������/������� ���*���������������%��� !������

���& �����"�� ������������������=��������������(Recommended Actions)

11. ������'( ���'��)�� �������� ��������9! (Responsibility &Target Completion Date)

12. ��!����� 0� ����������� �(Actions Taken)

13. ���������� ������!�����������

Copyright JCAHO 2001 79

���%��� �O�0�0� �� !������ ���& �����"�������������

� 0"��������%��� )"��/�� T���� 0"�K���%�%����������K���%����

� 0"����������K���%����

� &�����#��� !���O��� ��!��0"0� ������.U����

� 0"����%��!���

� ���������K���%����'������

� �������� ��������������-2�� )"� ����� �������� ���0"�� ����������0�V�V

� &�$�%����"���� Q��Q �� ��������� ���������� ��� �

Copyright JCAHO 2001 80

���%��� �O�0�0� �� !������ ���& �����"�������������

� &����������� ���������� ����� ����'������� 0"�����,�����K���%����

� �-2���� �����&,$� 0"0� �������� 0&� ������;��-2�� )"�0"�� ��%�� �����("�������� �) ���0"0� V�V� �) ��� ����'�������

� 0"��������� ��� ������'��)�� ��������!�� )��!�� �*����0")��!�� V�V

Copyright JCAHO 2001 81

'�������� ��!!����!��& �����"��

� ����������� �������(�� ��� & ����������

� �-2���� �"�'�������������1��0� ��������������� �� ��& ��� ����������� ��������� ����������;%"��S

� �������������� �)���R;V�V

Copyright JCAHO 2001 82

��R;���������&��'������

� ����� A �%�����;Q, ��*������ !��"��� ������������� ��

� ����� B ������������� ��&,$� �%"���0"1,�'( �W��

� ����� C ������������� �����'( �W�� �%"0"����� '( �W��0� ������%���

� ����� D ������������� �����'( �W�� �"�'��� % ������./�������� ��� � ��!�"�0"������%���%"�'( �W��

Copyright JCAHO 2001 83

��R;���������&��'������

� ����� E ������������� �����'( �W���"�'��� ������%���)� ����� ���% ���������������#�

� ����� F ������������� �����'( �W���"�'��� ������%���)� ����� ���% �����*�������� ������("*�����������&,$�

� ����� G ������������� �����'( �W���"�'��� ������%���1�����"'( �W��

����� H ������������� �����'( �W���"�'��� % ��������)"��)���%

Copyright JCAHO 2001 84

FMEA is

� a team-base, systematic and proactive approach

� process or design can fail,why it might fail

� how it can be made safer.

Copyright JCAHO 2001 85

� Purpose FMEA for

JCAHO identify where

and when possible

system failures could occur

� To prevent those

problems before they happen

Copyright JCAHO 2001 86

FMEA *����������+&�� NASA ��)"���+���#�� 1950 0� ����&���0������%������ * � � � � �X � + .1972 � ��" � K� �� %� � � � North

American Automotive Operations &�����#�� Ford Motor !����$�0� ������'����"������0�������%;�) ��"������9� �����������+0��0� �� ����������%;�) FMEA ������"��%������

���X �+. 2002 0� �� �������������������� ��%�������&�� FMEA 0��) ���=����!���������

Copyright JCAHO 2001 87

Ex. Sample RCA

1.�����%�����;

1.1.1.1. '( %��!���������

2.2.2.2. RM ward RM ward RM ward RM ward

nursenursenursenurse

3.3.3.3. ������

4.4.4.4. ����;

������ member %��!����� ATGATGATGATG ��%( �9����"����0� 1 &�� !,��! ��� ������InchargeInchargeInchargeIncharge ���� ����� 14.30 �. ������ InchargeInchargeInchargeIncharge %��!� ���������1�����;�� 0� T���� ATGATGATGATG �"��������$�����0���$�0� �� 0�� !,������"�����;0� T���� ATGATGATGATG 0���&�� � ���!������ &�����"��� 1 &�� � 5 ml �� &��&����"� 5mg/ml ����T���$��� 1 &�� !�� 25 mg �%"����� �����;�� T�� ATG 5ATG 5ATG 5ATG 5 mg + NSS 100 ml dripmg + NSS 100 ml dripmg + NSS 100 ml dripmg + NSS 100 ml drip ����;0� T���� ATG ATG ATG ATG 25 mg + NSS 100 iv dripmg + NSS 100 iv dripmg + NSS 100 iv dripmg + NSS 100 iv drip �� ��"'( �W��

��� RCA�%�����;�� ���&,$�

2. �-2�� ����� �� ATGATGATGATG ���&���

Copyright JCAHO 2001 88

4.������ Failure Mode

---- ---- -%��!���& �(��"�����%�����

����� MAR

----Q��1�������& ��!

----���%���������� MAR

----

���� Mode �� �'�%"��-2�� (Potential effect) 1 �� Y !�������

Y2 9$9"%����$��� A+A MAR

Y1 :�"������4-�A:�$?&���$;?������'���%����$��

I\1&).,/"1x2x3321Potential effect

Copyright JCAHO 2001 89

7. �����������'����=+��%�;(Analysis and Action planning for Critical Failure Mode

$����%����$�� �*;?���� ;?�:'�"

31/1/487/1/480.@.=)01.4 "+(( �('�%�����4-�A:'�"�� ATG ��$� A.� � 7��� >���'���%����$��

1.+1,L,/=@#.K/1"7;+L#$+#0+1,>L,A6"61

6& �*%��":<>'����%�&�%��*$�' -�>'-7"

6?� A6�",�A

��4���$

Critical Failure

Mode

Copyright JCAHO 2001 90

���#��� '�& "��(�&$+'6?-?����7

����������

%��!�"��������������������������%��!�� ���������% �����

����,�

�(��)"������

�� ������

�����'�

��V^�� /^5�H��� ��V^�� / ����Q� ��V^��

�����'����=;%��!�)������

%������!�����0 ��$�%���

�� & �(�'( �W��/2�%�!������'����%���

Copyright JCAHO 2001 91

��0� �* 1 � 6?#��,��9 ����7 30 # ��6�� "��$($��9� .� �- *���#H�,��'� ���A�&9#y�"��+(%�&� 10.00 '. %�&� 10.30 '. ( �+4%�', �&� 4'(�7"%�' %��8*�� alarm monitor #"9�

Copyright JCAHO 2001 92

��0� �* 2� 6?#��,�����7 72 # ��6�� "Tonsillectomy ' *���? �*�8>'%�&�02.00 '. ���"?�'�>�.&� Xygoma .��

� 6?#��,�����7 80 # $������- A-' &8*'&$+'(��'>�� 3����.��

93

-�7#.'� ����� �� RCA

1. %��"%�8*���7'.��, }>��A��T2. � >� �$ 6?%��*��:����$Flow3. ��A7#��%"F'#t(�4. ��%����(���A�'��� �*%��*��:��5. (�47"!(�/���������%��"#t(�6. (�-�%(�7:��#t(�+(;<����7. ���('"�7 B3�-�����.�9:8. ��"��$6&9. ���('"%#'.'� ��#H�A ��('� ����$+($)

Copyright JCAHO 2001 94

Flow �������������

������������ ���� ER

���������� �����������

����� �� �������� ��!

!� ��

����� �� NICU

Failure Mode

-�!������� ��"�

Failure Mode

-IC �!���� �� �����

-�#$��� �!�%��&�

Failure Mode

-��������!���� ��%��!��

-�!� ID �� �

Failure Mode

-NICU�!���� ��%��!��

-�!�� '�!���!� ��!&��� ������ #$��!#��!�� ��!&(�

Copyright JCAHO 2001 95

��)�g��=�

�)���3/���� ��1. h��*i������ 30 j +������k,! �

�2g��� �������k, 8 ��/�� l���m.����0����)�*3" -��

���2��0�3 � ����2��0�3 � �� ������0�+��*+��m

2��0�3����0�m��+,�"��+�� 1. ��0����m�"��+���� ��������

!3���i!-�m����m2��0�3�� �)������-�����(�

��3� 1 5 ���� �'�(* 1. h��!3������� m��!�"����

Copyright JCAHO 2001 96

ni*�

1. h��m��!�"�����)���3/���� �� (refer)

Copyright JCAHO 2001 97

Step 1

� Construct a Detailed Flow Chart of the Process� Multi-disciplinary participation of all those involved in the process

� Allocate plenty of time for this step� Be as detailed and complete as possible� Learn the flow chart process and symbols

� Flow charting software can help

Copyright JCAHO 2001 98

Step 2

� Determine each step that can “fail” and how it can “fail”

PhysicianWrites Order

MedicationOrder

Order PulledFrom Chart

Order TranscribedBy Unit Clerk into

MAR

Order TranscribedBy Pharm Tech

Into Pharmacy System

NCR copy oforder sent topharmacy

Writing illegibleOrder incompleteNon-formulary drugUsed felt penConfusion abbrev. usedLook-alike drug orderedContrary to approved clinical protocol

Order not pulled inTimely manner

Transcription error

Copyright JCAHO 2001 99

-���'����0��������������� ��

�+���� ��3/���� �� ��0�+��*+�

1. ����2� ������m *1. ������1. h�� ����), *1.��������0�+��*+�

��������3/���� ��

*2.����2� �����2��� 2. ��3/���� �������m2��0�3 *2.�.!31. h��

�����0�m

3. ����2� ��1. h�� *3. �/������ ��.3 *3. !� ni*���0�+��*+�

*4.�+��������),

A B C

Copyright JCAHO 2001 100

���*���

��0m ��/m.�+ �� m.�+ ��/3��k�� m.�+ ��/�����3�

Failure 2 1 1

Mode 4 3 2

3

A B C

Copyright JCAHO 2001 101

Requirements of LD.5.2

� For each identified "failure mode" identify the possible effects on patients (what engineers call the "effect"), and how serious the possible effect on the patient could be (what engineers call the "criticality" of the effect)

Copyright JCAHO 2001 102

Step 3

� Determine the “effect” of each possible “failure”

Wrong drug, dose, freq, routeDoesn’t followed approved clinical protocol

Wrong drugLook alike drug name used

Wrong doseConfusing abbreviation used

Cannot be read on NCR copyUsed felt pen

More expensive therapyNon-formulary drug

Wrong dose, freq, routeIncomplete order

Wrong drug, dose, freq, routeIllegible handwriting

Copyright JCAHO 2001 103

Step 4� Determining how serious the possible effect(s) can have on the patient – criticality

� For each effect:� Estimate likelihood of failure (occurrence scale rank)� Estimate severity of failure (severity scale rank)� Estimate probability that failure is detected

(detection scale rank)

� Then compute criticality index � is product of above three or CI=OSR x SSR x DSR

Copyright JCAHO 2001 104

A�+����

1. ����2� ������m*2. ����2� �����2��������0�m3. ����2� ��1. h�� *4. �+��������),

���*��� ��0m ��/m.�+ ��

Failure mode 24

A

Copyright JCAHO 2001 105

Occurrence ScaleLikelihood Probability

� Remote (1) 1 in 10,000� No known occurrence

� Low (2, 3, 4) 1 in 5,000� Possible, but no known data

� Moderate (5, 6) 1 in 200� Documented but infrequent

� High (7, 8) 1 in 100 � Documented and frequent

� Very High (9, 10) 1 in 20 � Documented, Almost certain

Copyright JCAHO 2001 106

Severity ScaleOutcome possibilities

� Slight annoyance (1)� May affect the system

� Moderate System Problem (2, 3)� May affect the patient

� Major System Problem (4, 5)� May affect the patient

� Minor Injury (6)� Major Injury (7)� Terminal Injury or Death (8, 9)

Copyright JCAHO 2001 107

Detection ScaleLikelihood Probability

� Very High (1) 9 out of 10� Error always detected

� High (2, 3) 7 out of 10� Error likely to be detected

� Moderate (4, 5, 6) 5 out of 10� Moderate likelihood of detection

� Low (7, 8) 2 out of 10 � Low likelihood of detection

� Remote (9) 0 out of 10 � Detection not possible at any point

Copyright JCAHO 2001 108

Risk Priority Number: RPN

Severity = K/1",O0H,$ 0–10Occurrence = `#+1@>+E& 0-10Detection = K/1"@1"1,7N0+1,L,/==). 0-10

RPN = S x O x D= 7 x 3 x 5 = 105

Copyright JCAHO 2001 109

Step 4 (con’t)

� Rank prioritize the failure modes based on their criticality index.

Copyright JCAHO 2001 110

FMEA / RCA

5 >��.P���S2. �a�� ��5��V���W�V

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E

T

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OCC

Potential

Cause (S) of

Failure

S

EV

Potential

Effect(s)of

Failure

Potential

Failure

Mode

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Copyright JCAHO 2001 111

Example: Top 5 criticality-indexed failure modes*

� Having lethal drugs available on floor stock� Mistakes in math when calculating doses� Doses or flow rates for IV’s calculated incorrectly

� Not checking armbands before administration� Excessive drugs on nursing floor stock

*From: E. Williams and R. Talley “The Use of Failure Mode

Effects and Criticality Analysis in a Medication Error

Subcommittee” Hospital Pharmacy 1994 (Apr); 29(4): 331-338

Copyright JCAHO 2001 112

Requirements of LD.5.2

� For the most critical effects, conduct a root cause analysis to determine why the variation (the failure mode) leading to that effect may occur

Copyright JCAHO 2001 113

Step 5

� Conduct root cause analysis of top CI failure modesEquipment People

Environment Process

IllegibleHandwriting

Poor handwriting skills of MDMD not informed of need/P&P

No verification processNo list of unapproved abbrev.

Lack of MD order entryLack of Preprinted Order Sheets

Copyright JCAHO 2001 114

The three The three The three The three

levels of levels of levels of levels of causecausecausecause

Consequences

Action

Intent

Component Component Component Component

Causes Causes Causes Causes (Physical)(Physical)(Physical)(Physical)

Decision Roots (Human)

Deficiencies in

Organizational Systems (Latent)

The logic tree root system depicts the origin of failureThe logic tree root system depicts the origin of failureThe logic tree root system depicts the origin of failureThe logic tree root system depicts the origin of failure

115

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Copyright JCAHO 2001 122

Requirements of LD.5.2

� Redesign the process and/or underlying systems to minimize the risk of that failure mode or to protect patients from the effects of that failure mode

Copyright JCAHO 2001 123

Step 6

� Brainstorm actions that could reduce the criticality index starting with failure modes that have the highest CI value that:� Decrease likelihood of occurrence� Decrease the severity of effects� Increase the probability of detection

Copyright JCAHO 2001 124

Requirements of LD.5.2

� Pilot test and implement the redesigned process.

� Identify and implement measures (indicators) of the effectiveness of the redesigned process.

Copyright JCAHO 2001 125

Requirements of LD.5.2

� Implement a strategy for maintaining the effectiveness of the redesigned process over time.

Copyright JCAHO 2001 126

Note similarities to PI

� PI.2 The new/modified process is designed well.� PI.2.1 Performance expectations are established for new/modified processes

� PI.2.2 The performance of new/modified processes is measured

� PI.5 Improved performance is achieved and sustained over time

Copyright JCAHO 2001 127

Remember

� Take small bites – keep it simple.� FMEA on PCA

� Think: “what could possibly go wrong”� Or what has gone wrong frequently in past

� Any modification to the process, creates new risk points.

Copyright JCAHO 2001 128

Parting Thought

� On survey, JCAHO is currently not evaluating how good your FMEA process is.

� JCAHO is evaluating whether you used a proactive process (that includes the elements of the intent) to determine risk points and then took action to reduce the risk

129

Questions?