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LAB ERRORS
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LAB ERRORS

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analytical errors in laboratory …

analytical errors in laboratory
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  • In a normal state the outcomes of all these cases will be positive. In almost all cases patients show improvement and have been subjected to the best possible care.
  • However, there is an dark side of medicine to which, thankfully, only a small proportion of cases are exposed. Nevertheless, this is an side of medicine which is of utmost concern to one and all.
  • The child: can be a victim of an adverse event due to a misprescription of the dose of Abx by the physician, a miscalculation of the dose administered by the nurse or simply an dispensing mistake by the pharmacist. The female patient: can have an advanced metastasis lesion present simply because the margins of the tumor were missed or the surgeon improperly resescted the tumor living behind a focus of cancerous growth which further grew and gave rise to subsequent complications.
  • This definition proposed by the IOM has been widely accepted and used today. The term “health services” refers to wide array of services that affect health, including mental and physical illnesses. The term “individuals and populations” draws attention to the different perspectives that need to be addressed. The phrase “desired health outcomes” refers to outcomes that patients desire and highlights the crucial link between how care is provided and its affects on health. Interestingly, the definition emphasizes that high quality care increases the likelihood of beneficial outcomes. It reminds us that quality is not identical to positive outcomes and poor outcomes can still occur, despite the best possible care, because diseased can often defeats our efforts. A decade later Campbell et al. defined quality of care as…
  • The essential domains of quality of care co-incide with the specific areas that have to be improved. Safety: avoiding injuries to patients from the care that is intended to help them. Effective: providing services based on scientific knowledge to all who could benefit and refraining from providing services to those not likely to benefit. Patient centered: providing care to that is respectful of and responsive to individual patient preferences, needs and values and ensuring that patient values guide all clinical decisions. Efficiency: avoiding waste including waste of equipment, supplies , ideas and energy. Equitable: providing acre that does not vary in quality because of personal characteristics such as gender/ethnicity, geographic location and socio economic status. Accessibility:the most basic dimension of access to health structures is geographic/physical access. This may relate to geographical barriers to getting to healthcare facilities such as rurality or use of premises themselves such as access by disabled and elderly people.
  • Let me start with defining some of the key terms which will be used during the course of my task and our discussion Error per se according to Webster's can be defined as… Medical error has two components in its definition: - First part constitutes an error of execution (e.g. antibiotics were given properly but patient was known to have developed resistance to it, or during the repair of a hollow organ perforation a vessel was punctured leading to a massive hemorrhage) - Second part constitutes an error of planning, when the initial action plan of management may itself be wrong (e.g. a misdiagnosis resulting in incorrect treatment)
  • ADVERSE EVENTS – may not always be preventive. Whereas negligence is always preventive. Negligence is the failure to meet the standard of care reasonably expected of an average physician qualified to take care of the patient in question. The standard of care is assigned by various regulatory bodies.
  • IOM released its report in 1999 (“To Err is Human”). The report raised a lot of questions and public awareness soared with respect to errors in medicine when the media took a key interest in the area. It also prompted the then-President of the US, Bill Clinton, to create a committee to look into the report and impose its recommendations. The report has had major implications on health care delivery. Some of these implications are recognitions of the following factors…
  • IOM report is largely based on Harvard Medical Practice Study (HMPS); it quotes at the prevailing of errors in medicine , it can be estimated that nearly 48,000-98.000 deaths are caused by them in US/yr. HMPS (1991) -based on admission of New York hospitals in 1984. -they analyzed a total of 30,195 cases discharged from NY hospitals in 1984. -State wide incidence rates for adverse events were –3.7% (3.2-4.2) -2.6% of these adverse events caused permanent disability and 13.6 % caused deaths. - extrapolating this data to all the discharges in NY state they felt that out of a total of 2,671,863 patients discharged. 98.609 patients suffreed adverse events and a total of 28,179 adverse events had negligence attached to them.
  • QAHCS- 16.6 % (15.2-17.9) admissions are associated with an Adverse event -8.3% of admission were preventable errors. -13.7% (12.2-15.2) of theses adverse events resulted in permanent disability -4.9% (3.8-6) of the adverse events resulted in death -51% adverse events had high preventability. -adverse events associated with decision making associated with increased preventability, permanent disability and death. -errors of omission(52%) were twice as common as errors of commission (27%). extrapolating the data to all hospiatls in australia in 1992 : 470,000 admission and 3.3 million bed days attributed to adverse events. Utah and Colorado study: - the sample consisted of 15,000 non psychiatric discharges in Utah and colarodo Adverse events were noticed in 2.9% hospitalizations. -death in 6.6 % of these adverse events -8.8% of adverse events were due to negligence -operative adverse events constituted 44.9% of all the adverse events. Canadian statistics are as yet unavailable, and are awaited in the year of 2004.
  • Schimmel- Prospective study, YALE UNIVERSITY MEDICAL SERVICE OF THE GRACE NEW HAVEN COMMUNITY HOSPITAL. Steel et al. - Prospective study/ University Hospital, Boston university. Brennan et al. – retrospective record review/ New york hospitals. Wilson et al . - retrospective record review/ New south Wales and south Australian hospitals Thomas et al.- retrospective record review/ Utah and colarado hospitals. Vincent et al- retrospective review/ London area hospitals. ALSO SEE ATTACHED TABLE FOR MORE INFO.
  • According to HMPS-II, performance error has been cited to be the major cause for errors. PERFORMANCE includes such things as inadequate preparation of patient before procedure, inadequate monitoring after procedure, use of inappropriate or outmoded form of therapy, avoidable delay in treatment PREVENTION- failure to take precaution to prevent accidental injury/ failure to use indicated tests DRUG TREATMENT is an error in dose or method of use, failure of a proper follow up SYSTEM defective equipment or supplies, inadequate staffing, inadequate training or supervision
  • The slide shows comparison of health care with other industries. Health care falls in the high risk category in terms of number of people seeking medical attention and lives lost . Even though bungee jumping is in the same hi-risk category , but the number of people indulging in this activity is far less than the people falling sick and seeking medical care. Taking into account a very conservative approach even 0.1% of errors in medical care is unacceptable, simply keeping in mind the huge population seeking medical care every day.
  • This statement by Reason amplifies the belief that errors can be made by any individual and any setup. It does not occur only by incompetent professionals and even the smarter individuals are as prone to errors as any one else in an unsafe system
  • This is a typical scenario witnessed as an aftermath of an error: After an adverse event occurs, it takes a couple of hours to a few days to figure out what exactly occurred, and then is followed by an formal investigation which may take weeks to months to years to establish a cause for this error. In the meantime the investigators and organization have an theory established for the critical incident. Finally, when the investigators zero in on a human link and human factor to the incident, the enquiry is completed with the cause of error established as a human factor.
  • Cognitive psychologists and human factors experts have taught us that errors often happen because of condition beyond individual control- defects in the system in which we work that lead us to make mistakes. These system cause are the roots of all errors.
  • ENVIRONMETAL FACTORS: Fatigue-decreases work efficiency, fatigue and patient safety not compatible. Work over load- decreases commitment, increases fatigue Equipment- enhances and magnifies errors even at optimum functioning of humans Physical agents- sound,light and heat disturbances of normal human and equipment functioning. INDIVIDUAL: Mistakes- are in human nature Negligence- grossly unpardonable taken care by regulatory bodies/ professional bodies Incompetence- should be tackled at regulatory level for licensure purposes Violations- following of evidence based practices/guidelines and policies should be the norm. ORGANIZATRION: Management- lax/ inefficient/vague policies and guidelines encourage errors. Errors maximum in an organization where patient safety is not prioritized. Communication barriers Established hierarchy-restricted freedom in activity or questioning superiors decisions. INADEQUATE MOTIVATIONS:Inappropriate ethics, economic incentives, and lack of encouragement to practice patient safety may all encourage error making.
  • Practitioners work at the sharp end of the system. The blunt end of the system generates resources , constraints and conflicts that shape the world of technical work and produce latent failures. The practitioners like doctors and pilots are only operating at the sharper end of the pyramid and hence have relatively less control over the error generating mechanisms which can be better controlled by the organizational policies which form the base of the pyramid.
  • This slide shows a detailed synopsis of a patient as a result of interference in her TSH immunoassay. It illustrates the effect of an error on patient care and its cost.
  • She was treated with single dose of 2 mg thyroxine orally and hormone levels were measured over a period of 19 days. During a period of 2.5 years this patient had 15 clinical consultations with her primary care physician and specialists. 77 lab tests and Pituitary CT.The patient was treated with a high thyroxine dose unnecessarily for more than one year. It appears that interfering antibodies in her serum effected the TSH immunoassay.
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  • Non–punitive: punishment should not be the goal, error reduction should be the main focus. Preventive: in approach rather than punishment oriented Confidential: and it should be used only for the purpose of improving patient safety and reports should not be used as evidence against the reporter. Independent: of any external influence and not involved with licensure. Respectful of patient needs: should involve patient at all levels of decision making and patient should be notified of error occurrence. Prompt: it should be not delayed and hidden until discovered.
  • Health care providers and health care seekers should understand that medicine is a complex entity and that physicians are also prone to make mistakes and they are not infallible. The fact that an error has occurred is sometimes hidden because of this factor and the scare of losing license or malpractice claims or being subjected to peer review and ensuing punishments. The lack of appropriate communication due to language, hierarchy or simply not understanding a point of view expressed or misunderstanding the whole view. No clear cut guidelines or models established as far as errors are concerned No adequate funding or research directed towards this end.
  • CPSS: estimates that there are 10,000 adverse events in the province each year, 400 resulting in death. The policy of disclosure states “ every physician must as son as possible inform his/her patient or the legal guardian of all AE’s/errors/complications that may have occurred in the course of patient care. CPSM: When harm occurs in the course of a patient's medical care, the physician responsible for that patient (including weekend or vacation coverage) must discuss the event with the patient. The discussion should occur promptly, taking into account the patient's medical condition. CPSO: The purpose of this policy is to affirm the College's position that patients are entitled to be informed of all aspects of their health care. This includes the right of a patient to disclosure of harm that may have occurred to him or her in the course of receiving health care.
  • Saskatchewan- An apology or expression of sorrow is not intended as an admission of guilt or assigning o blame. Manitoba- The policy recognizes the importance of physician avoiding speculation and disclosing only what is known at time of discussion. Ontario- Although manadatory for the physician to report the adverse outcome, patient has a right to refuse discussion of the event. Then , physician absolved of the responsibility. Quebec- Lacks the formal system of disclosure of harm that other provinces have but the concept is integrated into their code of ethics. Nova Scotia and NFLD- are considering the implementation of a policy.
  • JCAHO- In 2001, a new pt safety standard was implemented for accredited hospitals that required the disclosure of all outcomes of care that was good or bad. NHS: Doctors and managers in the NHS were placed under a statutory "duty of candour" requiring them to tell patients when a negligent act or omission causes harm, under plans for sweeping reform of the clinical negligence system. A new NHS "redress scheme" will offer a compensation package of remedial care, apologies, and compensation up to £30 000 ($49 670; €43 170) without the need for litigation, and no-fault compensation for babies with severe birth related neurological damage. The redress scheme, to be administered by a new body based on the NHS Litigation Authority, is the key plank of Making Amends , the long awaited report from the chief medical officer, Professor Liam Donaldson.
  • -Physicians are taught that the foundation of the physician-patient relationship is trust, and trust is based in part on truthfulness. -Patients have rights and providers have responsibilities -Financial consequences involve admitting mistakes and incurring the associated compensatory costs or not admitting mistakes and incurring associated compensatory and punitive damages for the mistakes that are discovered later.
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  • Transcript

    • 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. 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. The Dark Side of Medicine/Health Care
    • 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. 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. ISO DEFINITION OF QUALITY “The degree to which a set of inherent characteristics fulfils requirements.” ISO 2000
    • 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
    • 8. DOMAINS IN QUALITY OF CARE SAFETY EFFICIENCY PATIENT CENTEREDNESS EFFECTIVENESS ACCESS EQUITABLE
    • 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. 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. Medical Error In The News
    • 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. Medical Errors in the News Saskatoon Star Phoenix, Nov. 24, 2003
    • 14. Saskatoon Star PhoenixNov. 24, 2003
    • 15. Star PhoenixOctober 22, 2010 Star Phoenix October 23, 2010
    • 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. Problems in Today’s Health Care • Case depicts eroding quality, patient safety and professionalism in todays practice
    • 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. 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. 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. 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. 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. 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. 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. 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. “ Error is not the monopoly of an unfortunate few” JAMES REASON, 2000
    • 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. Systems ErrorsFlaws in the systems and processes that contribute to most mistakes
    • 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. DILBERT
    • 31. The Reason: “Swiss Cheese” Model DECISION MAKERS INSTITUTIONAL SUPPORT SYSTEMLATENTFAILURE WORKING CONDITIONS EQUIPMENT CLINICIAN & PATIENTS Incident ACTIVE Trajectory FAILURE CRITICAL INCIDENT
    • 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. Howreliable is your cognition?
    • 34. Perception• We see what we expect to see• What we see depends on the context• We look for coherence and order
    • 35. Cognitive error is quantifiableIt is the distance between your ears
    • 36. Errors in Pathology and Laboratory Medicine• Enormous potential in diagnostic and other pathological activities• Routine quality assurance schemes inadequate in interferences
    • 37. Physician’s Action BrainOrdering InterpretationCollection Reporting Identification Analysis Transportation Preparation Steps in the Performance of a Lab Test
    • 38. Lab Request• ELIZABETH DOER and ELIZABETH DIER• WILLIAM SMYTH and WILLIAM SMITH• KELLY DAVIS and KELLY DAVIES
    • 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. 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. 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. 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. 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. 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. 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. 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. Finally, don’t bank on newtechnology saving you…..
    • 48. Questions• How many of us have made an Error? -What did you do?
    • 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. 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. NON - PUNITIVE PREVENTIVECONFIDENTIAL Respectful of Patient Needs INDEPENDENT PROMPT Results Oriented Pillars of Error Reporting Systems Oriented
    • 52. No Fault Model
    • 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. • 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. 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. 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. 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. 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. 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. 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. Canadian Provincial Polices on Disclosure of Harm as of May 2009 .
    • 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. 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. 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. 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. 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. 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. 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. Questions• So, You have made an Error? -What would you do NOW?
    • 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. Quality AuditPerformanc Evaluation e TAKE ACTION
    • 72. Janet Casey
    • 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. “We have tosee ourselves as servants of the patients, nottheir masters”Liam Donaldson, 2003
    • 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. THANK YOU

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