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analytical errors in laboratory
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  1. 1. Quality Care and Patient SafetyMedical Error, Quality Care and Patient Safety: What is all the Fuss About? Jay Kalra MD, PhD, FRCPC,FCAHS Professor, Department of Pathology College of Medicine Royal University Hospital Saskatoon, Saskatchewan
  2. 2. Case ScenariosCase 1: 7 year old girl diagnosed with meningitisCase 2: 34 year female with 2 children with a breast nodule Cases diagnosed early, effectively treated and followed up
  3. 3. The Dark Side of Medicine/Health Care
  4. 4. Case ScenariosCase 1: 7 year old girl’s dosage of antibiotics misprescribed or miscalculatedCase 2: 34 year female’s margins of tumour missed, resulting in improper resection and the tumour persists
  5. 5. Objectives• The concept of medical error, quality care/patient safety in health care• Analyzing the system and human contribution in medical error generation• Evaluating the barriers and incorporating cultural changes - Culture of Safety• Understanding the scope and concept of error in clinical laboratories• Dilemma of error/adverse e vents and ethical issues : the concept of disclosure
  6. 6. ISO DEFINITION OF QUALITY “The degree to which a set of inherent characteristics fulfils requirements.” ISO 2000
  7. 7. DEFINING QUALITY OF CARE “ Quality of care is the degree to whichhealth services for individuals andpopulations increase the likelihood ofdesired health outcomes and are consistentwith the current professional knowledge.” - Institute of Medicine1990“ Whether individuals can access the healthstructures and processes of care whichthey need and whether the care iseffective.” - Campbell et al. 2000
  9. 9. Some General Definitions Error• A mistake• Something incorrectly done through ignorance or negligence• A state of incorrect belief Medical Error• Failure of a planned action to be completed as intended or the use of wrong plan to achieve an aim
  10. 10. Adverse Events An undesired outcome resulting from medical management rather than underlying condition of the patient NegligenceFailure in meeting the expected standards of care by an average qualified physician Patient Safety Freedom from accidental injury
  11. 11. Medical Error In The News
  12. 12. Medical Error in the NewsNearly a quarter of patients leaving hospitalsreport adverse events: study Feb. 2,2004 Complications hit one in eight hospitalized Canadians April 13, 2004
  13. 13. Medical Errors in the News Saskatoon Star Phoenix, Nov. 24, 2003
  14. 14. Saskatoon Star PhoenixNov. 24, 2003
  15. 15. Star PhoenixOctober 22, 2010 Star Phoenix October 23, 2010
  16. 16. Another Case Scenario• A 55 year old lady Mrs. Burns, waiting for surgical biopsy of breast• A physician with long waiting list and wait periods• Amidst the physician’s busy schedule, he enters the examining room and…• “ so how’s Mrs. Don doing today? Now let’s finish with that endometrial curettage today !”
  17. 17. Problems in Today’s Health Care • Case depicts eroding quality, patient safety and professionalism in todays practice
  18. 18. The Institute of Medicine (IOM) 1999• Health-care systems are responsible for the high prevalence of medical errors• The complexity of medicine - many opportunities for mistakes to occur• Improving patient safety and reducing medical errors must occur at every level of the system IOM Report: To Err is Human
  19. 19. Magnitude of the Problem The IOM Report (1999) “To Err is Human”• Medical errors cause between 44,000 – 98,000 hospital deaths in US per year Harvard Medical Practice Study (1991)• 4% of hospitalizations suffered injury, 14% of these injuries resulted in death British Studies• Medical errors result in 40,000 deaths per year in Britain, making it the third
  20. 20. Magnitude of the Problem Quality in Australian Health Care Study (1995) • Suggest 11% of deaths in Australia are related to medical errors Colorado and Utah Study (2000) • 3% hospitalizations suffered adverse events • 7% of adverse events resulted in deathsRoyal College of Physicians and Surgeons of Canada (RCPSC)
  21. 21. A Review of Literature on Patient Safety Study Yea Data Rate of Fatality Prime r source Adverse Rates events of Events concern Schimmel 1964 University 20% 8% Drugs and Hospital Dx Procedure sSteel et al. 1981 University 36% 2% Drugs and Hospital Dx Procedure s Brennan et 1991 New York 3.7% 13.6% Drugs and al. Hospitals SurgeryWilson et al . 1995 Hospitals 16.6% 4.9% Drugs and in Australia Surgery Thomas et 2000 Utah and 2.9 ± 0.2% 6.6 ± Drugs and al. Colorado 1.2% Surgery HospitalsVincent et al. 2001 British 10.8% 8% Surgery
  22. 22. The Canadian Scene Hospitalized Canadians Forster et al. 2004• One in eight affected by an adverse event – 12.7%• One in twenty affected by an preventable event – 4.8%• One in hundred died due to the event – 0.6%• Medications; Operative Complications; Nosocomial Infections were the main causes• 61% of the patients experienced the event before index hospitalization Baker et al., CMAJ, 2004• One in thirteen affected by an adverse event – 7.5%• One in thirty-five affected by a preventable event – 2.8%• One in sixty-seven died due to the event – 1.5%• Delayed diagnosis of cancer, heart disease; drug overdose; inadequate/faulty equipment; communication error; discharged too soon; surgical error (which damaged other organs) were the main causes
  23. 23. Everyone Makes Mistakes It must be accepted that human errors will occur at a level of between 1/1000 and 1/5000 events, and that this will increase in stressful situations.
  24. 24. Frequent Sites of Error Occurrence• Emergency rooms • Operating rooms • Pharmacies • Laboratories • Clinics Types of Error Leading to Adverse Events 40 30 Percentage 20 10 0 Performance Prevention Diagnosis Drug Tmt. System Unclassified Type of Error
  25. 25. Comparison of Risk in Health Care with other Industries HIGH RISK (>1/1000) MODERATELives Lost/ Year RISK HEALTH CARE MINIMAL RISK Driving (<1/100,000) Bungee jumping Commercial Chemical Aviation Manufacturing Nuclear Power Number of Encounters Modified from R. Amalberti and L. Leape
  26. 26. “ Error is not the monopoly of an unfortunate few” JAMES REASON, 2000
  27. 27. Adverse Event Aftermath Establishing a Theory Formal HUMAN Figuring out Investigations CULPABILITY ESTABLISHED Hours | Days | | | Weeks Months- YearsIncident investigation normally stops with human error by practitioners as the ‘cause’ of the event
  28. 28. Systems ErrorsFlaws in the systems and processes that contribute to most mistakes
  29. 29. TE ENVIRONMENTA YS S M L FACTORS - Fatigue HUMAN - Workload - EquipmentORGANIZATION - Physical INDIVIDUAL- Management agents -MistakesDecision/Policies - - NegligenceCommunication - -Hierarchy Incompetence - Inadequate - Violations Motivations ERRORContributory Factors for Error Occurrence
  30. 30. DILBERT
  32. 32. Woods and Cooks – Blunt and Sharp End Model Organizational / Institutional Policies,Procedures and Regulations Resources and constraints Practitioner Expertise Errors Actions Results Monitored process
  33. 33. Howreliable is your cognition?
  34. 34. Perception• We see what we expect to see• What we see depends on the context• We look for coherence and order
  35. 35. Cognitive error is quantifiableIt is the distance between your ears
  36. 36. Errors in Pathology and Laboratory Medicine• Enormous potential in diagnostic and other pathological activities• Routine quality assurance schemes inadequate in interferences
  37. 37. Physician’s Action BrainOrdering InterpretationCollection Reporting Identification Analysis Transportation Preparation Steps in the Performance of a Lab Test
  39. 39. Frequency of Errors in ClinicalLaboratories ONE IDENTIFIED ERROR EVERY 330 283-8300 EVENTS LAB RESULTS 900-2000 PATIENTS REASONS FOR THE VARIANCE •Different study designs •Process variability at specific times •Imperfect error detection methods •Differing frequency of errors from one facility to another
  40. 40. Stages of Errors in Clinical Laboratories Equipment Malfunction Reporting or Insufficient Sample Sample condition AnalysisIncorrect Pre Analytical Post Analytical Improper Analytical Sample Data (46-68.2%) (7-13.3%) (18.5-47%) Entry Incorrect Sample Identification Handling/ Turn Transport Around Times Sample Mix-Ups/ Interference Kalra J , 2004
  41. 41. Importance of Error Reduction in Clinical Laboratories • Clinical laboratories serve as the Base for modern medicine • Clinical laboratorians trained in quality assurance – ideal professionals to raise the bar in improved quality of care • Clinical laboratory processes- expert execution and delivery of critical information for clinical decision making • Over whelming dependence of clinicians on laboratory information
  42. 42. Case Scenario A Case of Data Misinterpretation• 36 year old female pregnant patient (first pregnancy)• Low protein S - Warned about significant risk of thrombosis• Clinician unaware of low protein S values in most pregnancies without risk of thrombosis – Lab test MISINTERPRETED OUTCOME : Woman terminates pregnancy
  43. 43. A Case Study in Medical Error 48 year oldAPRIL Abbott 1998 AxSYM f T4 TSH h/o – tiredness/wt. loss/ mental slowing R x 25 μg/ day – 200 μg/ day TSHJULY Bayer 1999 tT 4 TSH ACS- 180Urea/ BloodLytes Count f T4 f T3 TSH t T4 t T3 R x 250 μg Thyroxine given, patient felt (Abbott better AxSYM) Adapted from Clinical Chemistry, 2003
  44. 44. R x 250 μg Thyroxine given, patient felt betterSEPT Bayer 1999 ACS- 180 Thyroxine Binding Globulin f T3 TSH f T4 Sex Hormone Binding Globulin Normal Pituitary CT, Normal FSH/LH Serial measures R x 2 mg over 19 days Thyroxine f T4 f T3 TSH Interference in TSH assays confirmed by SERIAL DILUTION in TSH-free serum MARKED NON- LINEARITY Adapted from Clinical Chemistry , 20
  45. 45. Laboratory Error Reduction Critical in Patient Care Likelihood of Error Clinical Setting Recognition• Medication Error • Moderate to High• Technical/Procedural • High Error (Surgery)• Incorrect or Insufficient laboratory tests ordered • Low• Laboratory test misinterpretation • Low (misdiagnoses/inappropriate treatment)
  46. 46. Consequences of Laboratory Error Inappropriate Test Selection and Result Misinterpretation Increased Costs of Care Diagnoses delay with increasedLab tests and Professional Labor length of hospital stays Laboratory Error Loss of Physician and Clinical and emotional laboratory staff time in consequences frominterpretation of incorrect tests unnecessary procedures and misdiagnoses
  47. 47. Finally, don’t bank on newtechnology saving you…..
  48. 48. Questions• How many of us have made an Error? -What did you do?
  49. 49. You’ve made a mistake From Mark Fleming, St. Mary’s University Will it Yes Can you Yes Conceal it before show? hide it? anyone finds out No No Can you blame someone Yes else, or special circumstances? Bury No it Could an admission No Get in first with damage your career your version of prospects? events Yes Sit tight and hope the problem goes away Problem avoided
  50. 50. Rationale for Developing a Model for Clinical Laboratories• To re-ensure the primary goal of laboratory managements- Provision of Quality Laboratory Diagnostic Services• Absence of an uniform standardized model for clinical laboratories• Provision of specific policies, protocols, objectives and guidelines• Integration of research and ideas- prevention of fragmentation• Systemic and human factors accountability for laboratory errors and blunders
  51. 51. NON - PUNITIVE PREVENTIVECONFIDENTIAL Respectful of Patient Needs INDEPENDENT PROMPT Results Oriented Pillars of Error Reporting Systems Oriented
  52. 52. No Fault Model
  53. 53. Disclosure• Disclosure of Medical Errors/Adverse Events to patients is a challenge for heath care providers and institutions• Many studies have suggested that harmful medical errors are infrequently disclosed to patients/families
  54. 54. • Disclosure may be viewed as: – a part of informed consent process that enhances patient decision making – physicians ethical duty to tell the truth in the fiduciary physician-patient relationship• Open communication with patient about error is not seen as a common practice
  55. 55. Rationale for Disclosure• Adverse events are common in health care• Open and continuous communication with patients essential to ensure their partnership in health care• Patients right to receive accurate information to make informed decisions about their care• Disclosure of adverse events and discussion of details with patients is uncommon• The focus on enhancing quality care should be supplemented by policies of increased honesty and openness with patients
  56. 56. Barriers to Disclosure• Mentality / Attitude• Lack of Adequate Communication• Lack of a Model to follow• Threat of legal action• Threat of regulatory sanction• Lack of resources• Fatigue factor
  57. 57. Patient Disclosure The Who’s, When’s and What’s Who Should Disclose Who Should Disclose•The individual most appropriate to handle the discussion asidentified by the concurrence of the team•May be a doctor, nurse, manager, social worker, allied healthcare professional When to Disclose• Largely situation specific• As a general rule, disclosure should be made as promptly aspossible , and as appropriate given the patients medical andemotional condition
  58. 58. Patient Disclosure The Who’s, When’s and What’s What to Disclose• Disclosure is a process - a void speculating and state what is known at the time• Nature, severity and cause of the unanticipated outcome presented in a non-judgmental manner• Expression of regret about the unanticipated injury or result• Educate the patient and/ or patient family about the clinical implications of the unanticipated outcome and future plans
  59. 59. Canadian Progress on Disclosure of Adverse Events A Timeline April 2002 The College of Physicians and Surgeons of Saskatchewan is the first provincial authority in Canada to release a policy on disclosure of adverse events and errors that occur in the course of patient care September 2002 The College of Physicians and Surgeons of Manitoba approves a policy that requires full disclosure from the physician when harm occurs in the course of the patients medical care February 2003 The College of Physicians and Surgeons of Ontario approves a policy to disclose any harm that occurs during patient care
  60. 60. THE CANADIAN INITIATIVE Province Disclosur Year Key Points e Policy FormulatedSaskatchewan Yes 2002 Include an apology Manitoba Yes 2002 Avoid speculation Ontario Yes 2003 Patient can refuse discussion Quebec Yes - Integrated into code of ethicsNewfoundland Yes 2006 Not an admission ofand Labrador fault or liability Nova Scotia Yes 2008 Initiated quality assurance programs
  61. 61. Canadian Provincial Polices on Disclosure of Harm as of May 2009 .
  62. 62. International Progress on Disclosure of Adverse Events A Timeline July 2001 Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in USA implemented disclosure of unanticipated outcomes as a new accreditation standard July 2003National Health Services (NHS) of U.K unveils a plan making it statutory for doctors and managers to inform patients about a negligent act or omission that causes harmOffers a package in the form of remedial care, apologies and monetary compensation in return for waiving the right to litigate
  63. 63. International Progress on Disclosure of Adverse Events A Timeline July 2003 Australian Council for Safety and Quality in Health Care implemented a national standard for open communication in public and private hospital following an adverse event in health care Integration of disclosure with risk management analysis and investigation of critical event
  64. 64. Disclosure Follow Up• The follow up is an important step in the process• Should occur at the earliest possible opportunity• Patient should be given feedback on the progress and information about the event investigation• Patient and family offered opportunity to discuss with other relevant professional(s)• All previously unanswered queries are responded to
  65. 65. Failure to Disclose The Consequences• Broken Trust- Mutual respect and trust patients expect from their provider suffers• Ethical Challenge- Undermines the primary responsibility of the provider to their patient• Financial Factor- May increase the likelihood of a lawsuit and increase the punitive damage award
  66. 66. Our View• Error disclosure – standard of care• Disclose Promptly• Be a leader and accept responsibility• Assure and apologize• Outline a plan of management• Offer a second opinion• Emotional support• Document discussions• Protection from institutional retaliation
  67. 67. CONCLUSION Clinical Laboratories should:• Attain peak performance levels both in terms of medical error reduction and cost effectiveness• Incorporate modern quality management techniques towards enhancing patient safety• Adopt an approach of Designing (safer systems), Evaluating (success and benefits of the systems) and Practicing (these systems efficiently)• Measure their success in terms of ‘benefits’ accrued by the patient rather than the ‘less harm’ caused to the patient
  68. 68. Conclusions and Recommendations• Clinical laboratories should set the standard for error-resistant, robust and continually improving healthcare processes• Clinical laboratories must comprehensively understand clinician’s needs and strive to meet their expectations• Integration of laboratory medicine into overall clinical workflow is essential• Identify key areas for improvement and test all solutions before full implementation
  69. 69. Questions• So, You have made an Error? -What would you do NOW?
  70. 70. You’ve made a mistake From Mark Fleming, St. Mary’s UniversityTake ownership of the problem and assess the possible consequences Are they Yes Tell someone potentially senior immediately serious? No Take corrective action and inform those affected Co-operate fully to correct Investigate why the mistake the error and review occurred procedures Is there a flaw Yes Share your discovery and in the system? improve the process No Try and learn from your mistake Problem solved
  71. 71. Quality AuditPerformanc Evaluation e TAKE ACTION
  72. 72. Janet Casey
  73. 73. Quality Concepts Enhancing Patient Care• Quality system management (QC,CQI,QA)• Interdisciplinary quality indicators study• Biological variation and evidence based strategies/clinical guidelines studies• Utilization /risk management/concordance studies• Six sigma quality management• Educational and training programs
  74. 74. “We have tosee ourselves as servants of the patients, nottheir masters”Liam Donaldson, 2003
  75. 75. Acknowledgements • Dr K. Lorne Massey • Dr Harry Emson • Dr Ajay Nayar Rajeev Chadha, Maxim Gertle-Jaffe, Lyndon Entwistle Natasha Kalra, Heather Neufeld, Mabood Qureshi ,
  76. 76. THANK YOU