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Why is there a focus on medical errors  in laboratories?

Because approximately 60% to 70% of medical decisions related to diagnosis and treatment involve the laboratory, laboratory science can play a crucial role in ensuring patient-safety.

Medical errors could be  ERRORS OF DIAGNOSIS Errors of treatment Errors of prevention Miscellaneous

Laboratory testing is a highly complex process. We know it should be safe but sometimes errors happen…TO ERR IS HUMAN!!

They always used to talk about the  medical errors by physicians and nurses. Now, what happened?

The publication of the Institute of Medicine (IOM) report, To Err Is Human has changed everything.

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A 2014 study estimated that diagnostic errors happen about 12 million times per year in US outpatients.

More than 13 billion tests are performed in over 250,000 certified clinical laboratories each year in the US, making it likely everyone will each have at least 1 test done in their life.

The Institute of Medicine stated that most people will experience at least one diagnostic error in their life.

In the United States, there occurs 251,000 deaths per year because of errors in medical care.

Medical errors are the third leading cause of death, only after heart disease and cancer .

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Let’s See What’s Meant  By Laboratory Error….

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Source:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3689332/

Boniniet  al. in 2002 A diagnosis that is missed, wrong, or delayed, as detected by some subsequent definitive test or finding

International Organization for Standardization (ISO) Technical Report A defect occurring at any part of the laboratory cycle, from ordering tests to reporting, interpreting, and reacting to results

Check Out These Definitions Of Laboratory Error

Laboratory error is defined as any defect from ordering tests to reporting and interpretation of results.  Lab test failures contribute to delayed or wrong diagnoses and unnecessary costs and care. Laboratory errors have a reported frequency of 0.012-0.6% of all test results which in turn has huge impact on diagnosis and patient management.

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brain
Physician's
Interpretation
Ordering
Collection
Transportation
Laboratorian's
Analysis

Prof. George Lundberg described the laboratory testing as “brain-to-brain turnaround time loop”

Pre-Analytical Phase First, pre-analytical phase in which requirement for a test is determined, the test is ordered and the patient is identified.

Analytical Phase The pre-analytical phase is followed by specimen collection and transport to the laboratory. The specimen is prepared and tested in the analytical phase.

Postanalytical phase During the postanalytical phase, the results are reported to the individual who ordered the test and any action or intervention is undertaken.

That’s no longer the situation.  You’ll be surprised to know that pre-analytical and postanalytical phase are more prone to error!!

I always thought most errors occur in analytical phase, and paid attention to proper calibration and testing!

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Plebani  And  Carraro   (Clin. Chem. 1997)

Evaluation and characterization of errors occurring in a stat (emergency) laboratory.  Plebani  and  Carraro  reported that 189 out of 40490 tests were wrong. Most errors occurred in the preanalytical phase; only 13% occurred in the intra-analytical phase.

Pre-analytical  68% Intra-analytical 13% Post- Analytical 19%

189 out of 40490 tests (0,47%) were wrong in an  emercency  laboratory

Errors Occurring In The Different Analytical Phase:

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Types of Errors in the three phases of  Total Testing Process

Image result for unnecessary laboratory test cartoon

Inappropriate laboratory test requisition

Analytical phase Instrument not calibrated Specimens mix-up Incorrect volume of specimen Interfering substances present Instrument precision problems Delayed transportation of specimen Procedure not followed

Post-analytical phase Incorrect reference value Physician not notified of a panic or critical value Incorrect interpretation of lab results by physician  Incorrect data entry of lab results Instrument precision problems Dilution and pipetting errors Procedure not followed

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Minimize the laboratory errors by  Quality Management System

Two Standards Organizations  ISO CLSI International Organization for Standardization Clinical and Laboratory Standards Institute

ISO Documents – Laboratory ISO9001:2000 Quality Management System Requirements  Model for QA in design, development production, installation, and servicing.  ISO/IEC 17025:2005  General requirements for the competence of testing and calibration laboratories ISO15189:2007  Quality management in the clinical laboratory

Inadequate attention to detail Poor sample control  Poor results verification Quality control and assessment Understaffed Non-validated tests Poor workload management Time pressure Poor quality management

A laboratory is a complex system and all aspects must function properly to achieve quality.

The entire process of managing a sample must be considered:  The beginning: sample collection;  The end: reporting and saving of results; All processes in between

HS1-A2 A Quality Management System Model for Healthcare Describes quality system model, 12 essentials Aligns to ISO 15189 and parallels ISO9000 Applies to all healthcare systems

GP26-A3 Application of Quality Management System Model for Laboratory Services Describes laboratory application of quality system model Relates the path of workflow to the quality system essentials Assists laboratory in improving processes Relates to HS1-A2 and ISO 15189

Sample Transport Sample Collection Laoratory Analysis Report Creation PATH OF WORKFLOW Report  Transport Result Interpretation

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How to apply the six aims of the Institute of Medicine (IOM)  to improve health care quality within Laboratory Practice

According to The American Society for Clinical Laboratory Science (ASCLS)

Medical Laboratory Professionals are stewards of patient safety and must promote a culture of safety defined by the IOM as safe, effective, patient-centered, timely, efficient, and equitable practice.

IOM’s Aims Description Self care Avoiding injuries to patients Effective care Providing care based on scientific knowledge Patient- centered  care Providing respectful and responsive care that ensures that patient values guide clinical decisions Timely care Reducing waits for both recipients and providers of care Efficient care Avoiding waste Equitable care Ensuring that the quality of care does not vary because of characteristics such as gender, ethnicity, socioeconomic status, or geographic location

Source:  The American Society for Clinical Laboratory Science (ASCLS )

The aim of clinical laboratory science and the services it provides is to improve patients' lives during the total testing process.  Although each phase of the total testing process is important to safe care, increased efforts must be placed on evaluating diagnostic services by IOM measures of health outcomes:

Safe laboratory testing assures  care that avoids harm to patients and enhances safe care outcomes through error prevention, continuous process improvement, and appropriate care for each individual.

Effective care  uses scientific knowledge to limit overuse, underuse, and misuse of laboratory testing services.

Patient-centered laboratory care  is responsive to, and respectful of, patient preferences, needs, and values, and must include either face-to-face or written communication for patients about medical laboratory tests and patient rights.

Timely laboratory services  reduce wait times for patients and other providers of healthcare, so that the next step in care is not delayed.

Efficient laboratory services  avoid waste, which includes time, supplies, equipment, energy, and ideas.

Equitable laboratory services  do not vary in quality due to patient characteristics such as gender, ethnicity, geographic location or socioeconomic status, and are tailored for individual circumstances.

Provide evidence-based laboratory practice for effective healthcare

Apply quality improvement principles to healthcare processes to reduce opportunities for errors that could harm patients and to improve patient outcomes;

Use informatics as an essential component of their practice, due to advanced technology of laboratory testing systems and integrated systems to manage and communicate information for laboratory testing systems;

Bring laboratory testing expertise to interprofessional healthcare teams as they develop and provide standards of care.

Adopt these IOM competencies into daily practice

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12 Essentials of  Quality Management in Laboratory

PERSONNEL  –  Competent staff is the most important asset of a clinical laboratory. The quality management system must emphasize on training, motivation and engagement of the staff.

ORGANIZATION  –  The laboratory must have a formal quality management system that supports standardized procedures. Management must ensure a quality driven culture along with an effective monitoring framework.

EQUIPMENT  –   All laboratory equipment must be maintained properly.

PURCHASING AND INVENTORY  –  It is important to make sure that raw inputs and other supplies are of high quality consistently. Also, materials and supplies must be stored properly.

PROCESS CONTROL  – This includes collection, handling, method verification and process validation. Activities must be followed as per the standard protocol.

INFORMATION MANAGEMENT  –  All kinds of information and data must be managed in a manner that ensures accuracy, security, confidentiality and accessibility to only the authorized personnel.

ASSESSMENT  -  Laboratories must compare their performance with internal quality standards as well as with industry benchmarks.

OCCURRENCE MANAGEMENT   –  Laboratory must be able to detect the occurrence of any error or non-conformance. Investigations can be facilitated to identify the root cause of the errors and prevent their future occurrence.  .

DOCUMENTS AND RECORDS   –  Create standard operating procedures (SOPs) for each process. Ensure that the relevant documents are available at the working stations, and are maintained accurately and securely.

PROCESS IMPROVEMENT   –   Laboratories must practice continuous improvement of its processes.

CUSTOMER SERVICE  –  Laboratories should aim towards providing a positive customer experience through understanding the customers’ needs and make improvements by gathering customer feedback.

FACILITIES AND SAFETY  –  Laboratories should create comprehensive set of procedures and standards related to worker safety, lab security, and hazard containment procedures. This will help to ensure a safe, secure and clean environment.  .

Organization Personnel Equipment Purchasing And Inventory  Process Control  Information Management  Documents And Records  Occurrence Management  Assessment Process Improvement  Customer Service  Facilities And Safety

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Laboratory Services: 2020 National Patient Safety Goals

The purpose of the National Patient Safety Goals is to improve patient safety.

Source:  https://www.jointcommission.org/standards/national-patient-safety-goals/

Identify patients correctly Use at least two ways to identify patients. For example, use the patient’s name and date of birth. This is done to make sure that each patient gets the correct medicine and treatment.

Improve staff communication Get important test results to the right staff person on time.

Prevent infection Use the hand cleaning guidelines from the CDC or WHO. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.

Goal 1  Ensure Correct Patient and Sample Identification At the time of specimen  collection At the time of analysis At the time of result delivery

Goal 2 Ensure the verification and communication of laboratory results requiring action on the part of treating clinician

Goal 3  Ensure time outs are performed prior to starting procedures Correct test preparation Correct patient position Safety precautions based on patient history or medication use

Goal 4 Ensure the identification, communication and correction of errors

Goal 5 Improve integration and coordination of laboratory patient safety role within healthcare organizations and operations among the following groups: nursing, administration, points of care testing personnel, and providers

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Whenever a nonconformity is detected, follow the PDCA cycle.  This will  lead to automatic continual improvement.

It identifies and characterizes problems so investigations can be carried out, root causes identified, and improvement projects initiated, thus eliminating reoccurrence.  It is based on principles of quality management, risk management, and patient safety.

Source:  https://www.medlabmag.com/article/1287

While Considering The Degree Of Risk For A Non-conforming Event

A nonconformity is any occurrence that is not according to rules and/or expectations. Examples are deviation of critical environmental or equipment parameters, accidents, wrongly packed samples, stock outs, etc.

The Laboratory Must Learn From Every Nonconformity.

Implement the best solution ACT Identify your problems PLAN Study results CHECK Test potential solution DO

Risk  Impact Business Considerations Serious ham 1 patient or employee Serious Financial loss Moderate harm  5-10 patients or employees Moderate Financial loss Minimal harm 11-30 patients or employees Low Financial loss No harm  31-100 patients or employees No Financial loss  Harm near miss 100+ patients or employees Near miss for Financial loss

How to use non-conforming event management program?

Investigate the cause of the nonconformance

Determine if any action is needed and, if so, perform necessary action

Identify opportunities to improve the efficiency and effectiveness of work processes

Identify opportunities to reduce or eliminate risks and improve patient safety

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Pre-pre-analytical Legal compliance Pre-analytical IT/IS Analytical Total Testing  Process Post-analytical Employee Concern Post-post-analytical Client Complaint Safety   Recall Billing Administrative Proficiency  Testing Inspection  Finding

Pre-pre-analytical Analytical   Client Error-Ordering Calibration Issue Client Error-Specimen Contamination Contamination-Client SOP Deviation Specimen Receipt  Delay Expired  Reagent/Material Demographic  Error - Client Instrument  Downtime Mislabeled  Specimen(s) - Client Barcode  Issue Switched  Specimens - Client Lot Number  Issue Unlabeled  Specimen(s) - Client Inventory Shortage Improper Specimen Collection Rerun - Equipment  Failure Interface  Error Rerun – Inconsistent  Results Multiple Orders  on Specimen Rerun – QC  Failure No Manifest  Received  Misplaced /Misrouted Specimen No Shipment  Received  Lost  Specimen - Redraw No Specimen  Received  Lost  Specimen - Irreplaceable Recall Collection Container Technology/Computer Issue

Source: Jennifer Dawson; Electronic Non-Conforming Event Management, Medical Lab Management Magazine, May 2016 – Vol 5, No. 4 Page 16

Create a blame-free environment that focuses on processes and NOT PEOPLE

Use coaching and mentoring to obtain compliance with processes.

Focus on staff education and training to recognize and report potential non-conforming events

Management of Nonconforming Laboratory Events; Proposed Guideline (GP32-P), published by the Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS)

Useful guidelines to handle the problems that compromise the quality of laboratory services

An action taken to eliminate the initiating cause of a detected nonconformity.  Corrective action is designed to eliminate the reoccurrence of a nonconformity Preventive action is designed to eliminate the occurrence.

Section 5  Creating a Culture to Discover and Report Nonconforming Events, discusses the importance of creating the right environment for effective nonconformance management.  Section 12  Management Review and Referral to Process Improvement for Long-term Corrective Action, explains when a root cause analysis (RCA) should be performed.

What is corrective and preventative action?

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Don’t forget to include all personnel involved in the error for the analysis rather than speculate

Root cause analysis (RCA) is a structured study that determines the underlying cause(s) of adverse or non­conforming events (NCEs).  RCA focuses on systems, processes, and common causes that were involved in the adverse event.  It then determines ways to prevent recurrence by identifying potential improvements in systems and processes that should decrease the likelihood of repeating the event.  The Goals of Performing a Root Cause Analysis

What happened Why it happened What to do to prevent it from happening again Determine 3 things

Quality management system SOPs define responsibilities and authorities for the root cause investigation process.  Root cause investigation is a problem solving activity focused on the system, not the personnel.  Root cause investigation leads to corrective action, which is intended to prevent recurrence of nonconformance.  Preventive action is a proactive process intended to prevent occurrence of nonconformance.

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The ‘5 Whys’ is the simplest method for structured root cause analysis.  It is a question asking method used to explore the cause/effect relationships underlying the problem.  The investigator keeps asking the question ‘Why?’ until meaningful conclusions are reached.  It is generally suggested that a minimum of five questions need to be asked, although sometimes additional questions are required or useful, as it is important to ensure that the questions continue to be asked until the real cause is identified rather than a partial conclusion.

(1) Why  was the TOT too long? The controls were  expired and testing had to be  deplayed . (2)  Why were there no non-expired controls? The order  didn’t get shipped in time. (3) Why  didn’t it get shipped in time? The order  wasn’t place on time. (4)  Why wasn’t the order placed on time? The person  who normally does the ordering was out sick and there was no one designated as the backup.

Reference: Williams et al. BUMC PROCEEDINGS 2001;14:154-157

Event: The turn-around time for a test was too long

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Equipment  Process  People Materials Environment Management  EFFECT Secondary Cause Primary Cause

The system failure is described in a box to the right of the diagram.

Add Bones:  Categories (4 M’s)  Man Power (Personnel) Machines (Equipment) Materials (Reagents and Supplies) Methods  Primary Causes Secondary C auses

They are most useful when the ‘5 whys’ is too basic, for example, where a complex issue needs to be considered in bite size pieces or where there is a lot of data that needs to be trended. In the diagram, the various causes are grouped into categories (such as equipment, materials or processes) and the arrows in the image indicate how the causes cascade or flow toward the non-conformity. When to use a fishbone diagram:  When identifying possible causes for a problem When a team’s thinking tends to fall into ruts

Sample Integrity Lipemia Hemolysis Interfering  subtances Clotting Incorrect tube

Sample Presentation Bubbles  Inadequate volume

Reagent Degradation Shipping Storage Used past expiration Preparation

Quality Control Material Degradation Shipping Storage Used past expiration Preparation

Operator staffing Short staffing Correct staffing

Calibrator Degradation Shipping Storage Used past expiration Preparation

Instrument Failure Software failure Optics drift Electronic instability

Inadequate instrument Maintenance Dirty optics Contamination Scratches

Atmospheric Environment Dust Temperature Humidty

Utility Environment Electrical Water quality Pressure

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Failure mode and effect analyses (FMEA) on all the processes of the laboratory are one of the most important activities for continual improvement.  FMEA is a process analysis that helps you to get insight in potential sources of nonconformities, the probability that they happen and the severity of the consequences if they happen, and it offers you the opportunity to prevent them.

SEVERITY (S) OCCURRENCE (O) DETECTION (D) RATING Hazardous without warning Very high failure is almost inevitable Absolute uncertainty 10 Hazardous with warning Very high failure is almost inevitable Very remote 9 Very high High repeated failures Remote 8 High High repeated failures Very low 7 Moderate Moderate occasional failures Low 6 Low Moderate occasional failures Moderate 5 Very low Moderate occasional failures Moderately high 4 Minor Low relatively few failures High 3 Very minor Low relatively few failures Very high 2 None Remote failure is unlikely Almost certain 1

Failure Severity Probability Control Risk Wrong client selected at data entry 8 3 7 168 Client does not receive results, but are on web view 4 4 7 112

Table of Ranking – Severity, Occurrence, Detection

Step 5:  Calculate a Risk Priority (RPN) = S × O × D