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Understanding  the  Founda0ons  of  Pa0ent  Safety  &      Applying  the  Principles  of  High  Reliability    

to  the  Healthcare  Environment  

Commun i c at i o n

Cu l t ure

Mindfulness Reliability

Laura  M.  Lee,  MS,  RN  Director,  Office  of  Pa6ent  Safety  and  Clinical  Quality  

Na6onal  Ins6tutes  of  Health  Clinical  Center  

Disclosures  

•  I  have  no  financial  interest  to  disclose.  

•  This  con6nuing  educa6on  ac6vity  is  managed  and  accredited  by  the  Professional  Educa6on  Services  Group  in  coopera6on  with  the  NIH  Pharmacy  Department.    PESG,    NIH,  and  all  accredi6ng  organiza6ons  do  not  support  or  endorse  any  product  or  services  men6oned  in  this  ac6vity.  

•  PESG  and  NIH  staff  have  no  financial  interest  to  disclose.  

Learning  Objec6ves  

•  Describe  the  magnitude  and  impact  of  errors  and  harm  in  healthcare;  specifically  in  the  medica6on  management  domain  

•  Discuss  how  the  principles  of  High  Reliability  Organiza6ons  can  be  applied  to  the  healthcare  and  pharmacy  environments  

•  Relate  how  an  organiza6on’s  culture  impacts  pa6ent  safety  and  describe  strategies  to  improve  an  organiza6on’s  safety  culture  

At  the  conclusion  of  this  ac/vity,  the  par/cipant  will  be  able  to:  

Obtaining  CME/CE  Credit  

If  you  would  like  to  receive  con6nuing  educa6on  credit  for  this  ac6vity,  please  visit:  

hSp://nih.cds.pesgce.com  

 

 

How  Safe  Is  Health  Care?     Bungee  Jumping  –  REALLY????  

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Clinical  Research:  Heightened  Responsibility  

Pa0ent  Care  

Clinical  Researc

h  COMPLEXITY

RISK

Healthcare  Complexity  •  Diversity  of  tasks  involved  in  the  delivery  of  pa6ent  care;  •  Dependency  of  health-­‐care  providers  on  one  another;  •  Diversity  of  pa6ents,  clinicians  and  other  staff;  •  Rela6onships  between  pa6ents,  health-­‐care  providers,  support  staff,  administrators,  family,  and  community  members;  

•  Vulnerability  of  pa6ents;  •  Impact  of  technology;  •  Clinical  research  mission  

Ac#ve  error:    An  error  that  occurs  at  the  level  of  the  frontline  operator  and  whose  effects  are  felt  almost  immediately        

Latent  error:      Organiza6onal  or  design  decisions  made  away  from  the  bedside  that  impact  the  care  and  contribute  to  the  occurrence  of  errors  or  allows  them  to  cause  harm  to  pa6ents.      

Sharp  end:    The  “actualizer”  of  the  process—the  person  actually  doing  the  task  (e.g.,  the  nurse  administering  a  medica6on;  the  surgeon  holding  the  scalpel)  

Blunt  end:    Parts  of  the  process  farther  away  from  the  ac6on  itself;  the  environment  in  which  we  deliver  healthcare.  

Preventable  event:    An  event  that  could  have  been  an6cipated  and  prepared  for,  but  that  occurs  because  of  an  error  or  other  system  failure  

The  Language  of  Harm  

Levels of defense

Medication

Allergy

Reason’s  Swiss  Cheese  Model  

Factors  that  Influence  Safety   Systems  

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•  An  interdependent  group  of  items  forming  a  unified  whole  

System  

•  A  system  in  which  there  are  so  many  interac6ng  parts  that  it  is  difficult,  if  not  impossible,  to  predict  the  behavior  of  the  system  based  on  knowledge  of  its  component  parts  

Complex  System  

Think:  Systems!  

Person  Approach  –  Focus  on  individual  –  Errors  are  a  product  of  carelessness  

–  Interven6ons:  •  Naming  •  Blaming  •  Shaming  

•  Retraining  

– Target  is  the  individual  

System  Approach  

–  Focus  on  condi6ons  and  environment  

–  Interven6ons:  •  Improving  the  system  

–  Targets    •  Pa6ent  and  provider  factors  •  Task  Factors  •  Technology  and  tool  factors  •  Team  factors  •  Environmental  factors  •  Organiza6onal  factors  

Person  vs.  System  

Culpable              Blameless  

Malicious  Act  

Fitness  for  Duty  Issue   System  

Failure  

Reckless  Behavior  

NO

YES YES YES NO

YES

NO

YES NO

YES

System  Failure  

At-­‐risk  Behavior  

YES

System  Failure  

NO

Managing Unsafe Events in the Clinical Center: A Strategic Model

NO NO Did  the  employee  act  inten6onally?  

Does  there  appear  to  be  evidence  of  

impairment  (e.g.,    ill  health,  substance  

abuse)?  

Did  the  employee  knowingly  violate  safe  procedures?  

Would  another  individual  from  the  same  professional  group  with  comparable  

qualifica6ons  and  experience,  behave  in  the  same  way?  

Were  the  consequences  as  

intended?  

Were  the  procedures  easy  to  understand  and  follow?  

Were  there  deficiencies  in  

training,  experience,  and  supervision?   Human  Factors  

Human factors refer to environmental, organizational and job factors, and human and

individual characteristics which influence behavior at work in a way which can affect

health and safety. Health and

safety-related behavior

Job

Individual

Organization INFLUENCE  

Human  Factors  &  Pa6ent  Safety     Human  Factors  

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Human  Factors  &  Pa6ent  Safety    

•  The  complexity  of  health  care  is  fraught  with  human  factors  issues  

•  Major  contributor  to  medical  error  

Processes Products

•  Individual  Characteris6cs  –  Knowledge,  skill  level,  experience,  intelligence,  

aitude,  fa6gue,  stress,  mo6va6on  

 

•  Nature  of  the  Work  –  Design  of  the  work  processes,  pa6ent  loads,  presence/absence  of  

teamwork,  complexity  of  treatments,  equipment  used,  interrup6ons  and  compe6ng  tasks,    

 •  Human-­‐System  Interfaces  

–  Pa6ent-­‐Device  interface,  Prac66oner-­‐Device  interface,  Micro-­‐system-­‐Device  interface,  Socio-­‐technical-­‐Device  interface,  equipment  loca6on,  sojware  control,  electronic  health  record  (CRIS)  

 

Human  Factors  

•  The  Physical  Environment  –  Architecture,  interior  design  and  layout,  

availability  and  placement  of  equipment,  work  flow  in  space,  ligh6ng,  noise,  temperature,  distrac6ons  

 •  Organiza6onal/Social  Environment  –  Authority/power  gradients,  group  norms  and  culture  ,  

communica6on/coordina6on,  “local”  procedures/prac6ce,  work  life  quality,  normaliza6on  of  deviance  

 •  Management  –  Organiza6onal  structure,  leadership,  staffing/pa6ent  load,  resource  

availability,  culture,  accountability  of  prac66oners,  employee  development  

 •  External  Environment  –  Clinical  research  environment,  poli6cal  pressures,  economic  pressures,  

public  awareness,  new  technology,  media  

Human  Factors  •  Gradual  process  in  which  an    unacceptable  prac6ce  or  standard  

becomes  acceptable    

•  Organiza6on/staff  become  so  insensi6ve  to  deviant  prac6ce  that  it  no  longer  feels  wrong  

•  As  the  deviant  behavior  is  repeated  without  catastrophic  results,  it  becomes  the  social  norm  for  the  person/team/organiza6on    

Normaliza6on  of  Deviance  

1.  Staff  believe  that  rules  are  not  well  conceived  and  inefficient  –  developed  by  those  who  are  not  in  the  trenches  of  care.  

2.  Staff  lack  of  knowledge  –    knowledge  is  imperfect  and  uneven    and  some  staff  may  not  even  know  the  reasons  for  the  prac6ce  and  procedure.  

3.  New  technologies  –    can  disrupt  ingrained  prac6ce  paSerns,  impose  new  learning  demands,  or  force  system  operators  to  devise  novel  responses  or  accommoda6ons  to  new  work  challenges.  

4.  Staff  belief  that  it  is  OK  to  break  a  rule  for  the  good  of  the  pa6ent.  

5.  Staff  belief  that  rules  don’t  apply  to  them  –  they  have  experience  and  can  be  trusted.  

6.  Staff  fear  about  speaking  up  when  deviant  behavior  is  observed.  

7.  Leadership  awareness  of  deviant  behavior  or  systems  problems  but  there  is  a    failure  to  bring  it  up  the  chain  of  command.  

Normaliza6on  of  Deviance  

Communica6on  

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0 20 40 60 80

Continuum of CareMedication Use

Care PlanningOperative Care

Information ManagementPhysical Environment

Human FactorsAssessmentLeadership

Communication

Ineffective communication

is a root cause in approximately

66% of Sentinel Events

Data Indicate….

•  Communica6on  is  the  “the  process  by  which  informa#on  is  clearly  and  accurately  exchanged  between  two  or  more  team  members  in  a  prescribed  manner  and  with  proper  terminology  and  the  ability  to  clarify  or  acknowledge  the  receipt  of  informa#on”  (AHRQ,  n.d.)    

Communication

Individual  Level  Barriers  •  Language  •  Lack  of  trust  •  Cultural  differences  •  Gender  difference  •  Mul6ple/split  loyal6es    •  Lack  of  team  experience    •  Distrac6ons    

Team or Microsystem Level Barriers •  Lack of well-articulated goals or purposes •  Role and leadership ambiguity •  Lack of structure or framework for

problem-solving •  Workload •  Power and authority •  Traditional hierarchical differentials •  Lack of leadership and vision •  Personal conflicts among team members •  Diffusion of responsibility •  Interprofessional rivalries •  Lack of effective information sharing

processes

Organizational Level Barriers •  Lack of leadership and vision •  Resource availability •  Legal constraints •  Rigid decision-making processes

Communication Barriers

The balance of decision-making power or the steepness of command hierarchy in a given situation

Authority/Power Gradients

Experienced/Leader

Inexperienced/Subordinate

STEEP

FLAT Peer Peer

Authority/Power Gradients

•  Most teams require some degree of authority gradient

•  Otherwise roles are blurred and decisions cannot be made in a timely fashion.

•  Healthcare environment is a very hierarchical world with inherent power distances

Authority/Power Gradients

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It  could  happen  here  -­‐  -­‐  -­‐  -­‐    •  Pharmacist  calling  a  physician  to  clarify  an  incorrect  inves6ga6onal  new  drug  order  is  met  with  anger  and  impa6ence  and  this  comment:        “And  when  did  you  get  your  medical  degree??”  

•  Fellow  afraid  to  ques6on  an  aSending’s  an6coagula6on  order  despite  her  certainty  that  the  order  was  wrong  

•  Opera6ng  room  staff  directed  by  senior  surgeon  to  flash  sterilize  unconven6onal  item  for  human  use    

Authority/Power Gradients

Express  Concern  

State  Problem  

Propose  Ac6on  

Reach  Decision  

Get  Person’s  ASen6on  

Cycle of Assertion

“Stop the line”

What is your “Safety Language”

HIGH  RELIABILITY  

High  Reliability  Organiza6ons  

•  An  error  or  lapse  in  safety  in  these  industries’  processes  can  result  in  tragic  outcomes  

•  Commercial  airlines,  aerospace,  and  nuclear  power  energy  are  among  the  most  risky  industries  but  are,  in  reality,  the  safest  enterprises  

•  We  approach  the  task  of  keeping  our  pa6ents,  staff,  and  organiza6onal  mission  safe  much  like  managing  an  airline  or  a  nuclear  power  plant  –  we  apply  the  five  principles  of  high  reliability  

•  Likewise,  a  lapse  in  proper  infec6on  control  in  the  care  of  a  pa6ent  with  Ebola  virus  infec6on  or  an  error  in  the  prepara6on  or  administra6on  of  a  high  risk  medica6on  can  be  catastrophic  from  a  personal  as  well  as  an  organiza6onal  perspec6ve  

Preoccupa6on  with  Failure  

•  We  all  need  to  be  the  “Eeyores”  of  the  healthcare  

•  Always  asking  about,  and  looking  for,  untoward  outcomes  that  could  result  from  our  care  processes  

•  We  ask  “WHY?,  WHY?,  WHY?,  WHY?,  WHY?  when  things  go  wrong  or  nearly  wrong  (e.g.,  near  miss)  

•  Tools  from  high  reliability  industries  help  us  iden6fy  risky  processes  and  behaviors  before  we  have  a  catastrophic  event  (e.g.  Failure  Mode  and  Effects  Analysis)  

•  Drilling  and  conduc6ng  “Day  in  the  Life”  drills/exercises  is  borne  of  this  Preoccupa0on  with  Failure  

Channeling  Your  Inner  Eeyore  

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Deference  to  Exper6se  

•  The  old  adage  “Father  knows  best”  does  not  rule  the  day    

•  Staff  involved  in  the  management  of  high  risk  procedures  and  the  care  of  complex  high  risk  pa6ent  pa6ents  (and  all  pa6ents,  for  that  maSer)  are  the  experts  about  how  the  processes  we  design  will  perform  -­‐  -­‐  or  more  importantly,  won’t  perform  –  and,  therefore,  play  the  lead  role  in  designing  processes  of  care  

•  A  challenge  is  managing  the  well-­‐inten6oned  “direc6ves”  of  staff  and  leadership  who  are  removed  from  day  to  day  bench-­‐side  or  bed-­‐side  care  but  have  a  vested  interest  in  the  care  of  pa6ents  

The  C-­‐Suite  Plays  Second  Fiddle  

Built-­‐In  Resiliency  

•  Every  organiza6on  must  develop  strategies  to  sustain  opera6ons  and  “bounce  back”  when  (not  if)  an  untoward  event  occurs    

I  Get  Knocked  Down  and  Get  Back  Up  Again  

•  The  ques6on  “What  if?”  needs  to  end  every  process  step  designed  in  the  care  of  high  risk  pa6ents    

o  What  if  a  pharmacists  dispenses  the  wrong  drug  or  if  a  staff  person  experiences  an  occupa6onal  exposure?  

o  What  if  the  public  has  a  nega6ve  reac6on  to  a  sen6nel  event  involving  a  medica6on  or  there  is  a  breach  in  technique?  

Sensi6vity  to  Opera6ons  

•  Leaders  and  staff  need  to  be  constantly  aware  of  how  processes  and  systems  affect  the  organiza6on  

•  “Safety  huddles”  should  be  used  liberally.    In  safety  huddles  staff  gather  briefly  (five  –ten  minutes)  to  discuss  issues/concerns  that  have  developed  over  the  course  of  their  tour  of  duty  

•  Each  employee  pays  close  aSen6on  to  opera6ons  and  maintains  awareness  as  to  what  is,  or  isn't,  working  

•  Leadership  huddles  are  equally  important  to  review  what  is  working  or  not  working  each  day  

Eyes  in  the  Back  of  My  Head  

Reluctance  to  Simplify  Processes  

•  Resist  simplifica6ons!      Look  beyond  the  obvious!  

•  The  me6culous  aSen6on  to  detail  in  the  complex  opera6ons  of  a  pharmacy  and  medica6on  management  is  an  example  

• May  be  beneficial  to  simplify  some  work  processes  but  avoid    failing  to  dig  deeply  enough  to  understand  an  issue    

The  Devil  is  in  the  Details  

•  The  ques6on:  “What  if?”  needs  to  end  every  process  step  designed  in  the  care  of  high  risk  processes  and  pa6ents    

Pa6ent  Safety  Culture  

An  organiza6on’s  values  and  behaviors  —modeled  by  its  leaders  and    

internalized  by  its  members  —    that  serve  to  make  pa6ent  safety  the  

overriding  priority.  

Pa6ent  Safety  Culture  •  Acknowledgment  of  the  high-­‐risk  nature  of  our  work;  

•  A  dogged  determina6on  to  achieve  safety;  

•  A  blame-­‐free  environment  where  individuals  are  able  to  report  errors  or  near  misses  without  fear  of  reprimand  or  punishment;    

•  A  commitment  to  learn  from  errors;  

•  Encouragement  and  expecta6on  of  collabora6on  across  departments  and  disciplines  to  solve  pa6ent  safety  problems;    

•  Leadership  commitment  to,  and  involvement  in,  pa6ent  safety.  

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Doing  it  RIGHT!  

“Error is the starting point;

not the conclusion” Sydney Dekker - “The Field Guide to Understanding Human Error”