Effect of Lab Errors on Patient Care Prof. Dr.Asim Mumtaz Shalamar Medical & Dental College Lahore

Patient & Health care team

“To Err is Human” Building a Safer Health System Institute of Medicine : 1999 8th Leading cause of death 44000 – 98000 deaths per year Kohn L, Corrigan J, Donaldson M, eds. To Err Is Human:Building a Safer Health System. Washington, DC: National Academies Press; 2000.

60% to 80% of patient management decisions are based on lab data

IMPACT ON PATIENT Psychological Trauma Wrong Diagnosis Delay in Treatment Legal Issues Inappropriate Monitoring Wastage of Resources Prolonged hospital stay Financial burden

Laboratory Medicine Every sample is a PATIENT

Why Do Lab Errors Occur ? 22 Clinicians 10 Surgeons 6 Paediatricians 12 Pathologists

Answer “Lab errors mostly occur due to instrument malfunctioning or wrong reporting…”

Frequency of Lab Errors 46 – 68% Preanalytical 8 – 17 % Analytical 18 – 47% Postanalytical Effects of pre analytical errors on quality of laboratory medicine : J Clin Biochem. 2010; 26(1): 46-49. Errors in medicine and errors in laboratory medicine: What is difference? Blood transfuse. 2010; 8:79-81.

TYPES OF LAB ERRORS Analytical Postanalytical Preanalytical LATENT ERROR ACTIVE ERROR

Latent & Active Errors Latent Errors Active Errors poor design, incorrect installation, faulty maintenance, bad management decisions, and poorly structured organizations Active Errors occur at the level of the frontline operator effects are felt almost immediately

Examples of Latent Errors in Lab IT Lack of instrument interface with LIS Equipment Main chemistry analyzer is overloaded and has no backup. Work Environment Culture of multitasking leads to error-prone environment Policy and Procedures Flaws in Policies and procedures. Staffing Chronic understaffing on evening and night shifts leads to high error rate. leads to many active data entry errors leading to long delays when the instrument is down

Preanalytical Variables Voucher – Wrong entry Patient Identification & Preparation Physician Order Missed Sample site selection & preparation Improper venipuncture technique Sample Labeling Inappropriate Container Delayed & Improper transport of Sample to lab

Preanalytical Variables Sample Accessioning in Lab Water Bath Temperature variation Centrifugation Wrong Labeling of tubes for analysis Inappropriate Storage of samples

Analytical Variables Instrument Error-Malfunctioning Improper Calibration Pipetting error Lack of specificity of method

Postanalytical Variables Wrong Entry of Test Results Doctor/Ward Staff not informed about abnormal Results in time Report Signed Without Confirming Result Delayed turn around time (TAT)

Frequency of Errors (Six Months Data) Variable Private Hospital Lab Public Sector Hospital Lab Total Samples 127,500 90,000 Total No of Tests Performed 611,081 475,000 Total No. of Errors 1530 2540 Error Rate 1.2 % 2.82 % Preanalytical 70.4% (1078) 56.7% (1440) Analytical 12.1% (184) 14.9% (380) Postanalytical 17.5% (268) 28.4% (720)

Frequency of Errors (Six Months Data) Phases Indoor Outdoor Total Errors Preanalytical 784 (72.7%) 294 (27.2%) 1078 Analytical 103 (55.9%) 81 (44.02%) 184 Postanalytical 194 (72.3%) 74 (27.6%) 268

Pre Analytical Errors

Effect of Haemolysis on Tests INCREASED ALT AST LDH CK Lipase Mg Creatinine Potassium Phosphate Urea, protein Iron, Ammonia DECREASED Bilirubin Insulin Albumin

Effect of Lipaemia INCREASED DECREASED Glucose Phosphorus Bilirubin Uric acid Total protein HbA1c Fructosamine Triglycerides D-dimer ALT/ AST DECREASED Sodium (pseudohyponatremia) HDL cholesterol Ceruloplasmin Prealbumin Transferrin

Interchange of samples Effect of Pre Analytical Error : Wrong Identification Public Sector Hospital Lab Patient Name: Sadiq Ahmad Age: 65 yrs Ward: Male Medical Date: 1-3-2011 MR #: 3003455 Tests requested: Blood Sugar Fasting LFTs Patient Name: Mr. Sadiq Age: 62 yrs Ward: Male Medical Date: 1-3-2011 MR #: 3003465 Tests requested: LFTs RFTs Anti HCV HBsAg Interchange of samples

Impact on Patient Delay in diagnosis Delay in treatment Prolonged hospital stay Wastage of resources Patient inconvenience (Repeat Fasting)

Effect of Analytical Error Example : Public Sector Hospital Lab Patient Name: B/O ABC Age: 6 Days Ward: Peads MR #: 2778333 Test Requested: Bilirubin Total 10-2-2011 12-2-2011 13-2-2011 19.5 mg/dl 17 mg/dl 21.5 mg/dl Consequence: Disparity in result  EXCHNAGE TRANSFUSION ?

Effect of Post Analytical Error Example Private Hospital Lab Patient Name: Iftikhar Age: 35 yrs Ward: Emergency MR #: 2022556 Test Requested: Trop I Result Reported: 4.2 ng/ml Actual Result: 0.42 ng/ml Consequence: Hospital admission  financial burden  Psychological trauma to the patient

How To Improve

Error Identification Error Identification & Documentation Q Probes Q Track Continuous monitoring

What we can do? Implementation of systematic error tracking system in daily practice

Training & Monitoring Training of the Nursing Staff Continuous Training & Monitoring of Lab Staff SOP & Sample Rejection Criteria

Internal Quality Control Program External Quality Control Program Quality Assurance Program Internal Quality Control Program External Quality Control Program Certification & Accreditation

LIS & HIS Interpretation & Monitoring of Reports Main Analysers – LIS Availability of reports on HIS

How To Gain Strength Policies & Procedures Commitment Communication

Thank You