RISK MANAGEMENT IN CLINICAL LABORATOR

RISK MANAGEMENT IN CLINICAL LABORATORY

In 1999 the Institute of Medicine (IOM) published a study entitled "To Err Is Human: Building a Safer Health System." Its estimate of the number of deaths and adverse outcomes caused by medical errors sent shockwaves throughout the healthcare community as well as the general population. Perhaps for the first time members of the healthcare community began to seriously look at the way healthcare is delivered and how the process could be improved to enhance patient safety.

Thus, one of the most beneficial results from the IOM study was that hospital workers and other healthcare providers realized that they urgently needed to fully and more effectively incorporate "risk" as a crucial component of their management. It is the goal of this course to present an overview of risk management with a clinical laboratory point of view and to hopefully show how risk management can improve the quality of care we give patients.

Definitions of Risk and Risk Management

A risk is a future event that may result in loss or injury. In healthcare, the future event specifically refers to injury to a patient (negative patient outcomes).

Risk management involves the creation of policies and procedures and the implementation of practices that are aimed at the prevention of future events that could result in negative patient outcomes. Basically, risk management is the process of making and carrying out decisions that will assist in the prevention of detrimental events. It also describes techniques used in the prevention of adverse consequences or losses if an unintended or unexpected event does occur. It is important to demonstrate how to analyze risks and what options a laboratory has in deciding how to deal with risks. Often, a critical incident that affects patient care is the result of multiple errors and system flaws that coincide.

Model of Accident Causation

Feasible Risk: Keep risks as low as reasonably practical. You can't make any process safer than is technologically and/or commercially possible.

Comparative Risk: Keep risks as low as other comparable risks. For instance, if the public accepts the risks of one activity, achieving that level of risk in another process is also acceptable. For instance, a risk question could be formulated like this: should healthcare be as safe as smoking, as safe as driving, or as safe as

flying?

De minimis Risk: Reduce risk until it is trivial. In safety culture, this goal is set as a probability of 10-6 or better.

Zero Risk: No risk is acceptable. Safety doesn't exist while there is still a chance of an accident with harmful consequences. Zero risk doesn't actually exist, of course, but nevertheless it can be adopted as a goal, and it is an particularly apt goal for certain tasks. For instance, a zero risk approach for the handling of nuclear weapons and reactors is probably a necessary one.[2]

Why Manage Risk?

Every director and manager is aware of that unexpected event are unavoidable at any point of time in a laboratory.Unfortunately, this negative unexpected events seriously affects on the effectiveness as well as the financial welfare of the laboratory which results into decrease output in terms of quality as well as quantity. Some of these negative events can have such devastating consequences that the sheer risk of them occuring cannot be left to chance. Occurrence of such event can be avoided using systematic and professional way of risk management.

The challenge is to assess and analyse the extent of risk and control risk in an appropriate and cost-effective manner. By using risk management strategies, the laboratory can approach risk in a structured and calculated manner.

Risk Reduction through Quality Systems and Improvement

• External Audits and EQA

• Internal Audits

• Preventive Actions

• Opportunities for Improvement

• Corrective Actions

Introduction to Patient Safety and Risk Exposures

Laboratory quality management and risk management plans that address processes in the preanalytic, analytic, and postanalytic phases of testing are key elements in ensuring patient safety. The preanalytic phase of testing includes all processes prior to the actual testing of a specimen. The analytic phase consists of all the processes involved in the testing of a specimen, and the postanalytic phase includes all the processes involved after test analysis. Clinical laboratories are engaged in the process of risk reduction all the time, but characterize it with different vocabulary.

Risk and the Clinical Laboratory

• Worker risk – Safety – Responsibility

• Patient risk – Patient Identification – Specimen Identification – Information – Analytic sensitivity and specificity – Report interpretation

• Laboratory risk – Financial – Liability    – Safety

Preanalytic Phase

A study that was published in 2002 concluded that 68 - 87% of laboratory errors occur in the preanalytic and postanalytic stages of the testing process with the majority occurring in the preanalytic phase.*

Steps in the pre-analytic phase occur both inside and outside the laboratory, and are performed by both laboratory and non-laboratory personnel. While the following list is not exhaustive, some of the most common sources of error in the preanalytic phase include:

Ø  Patient preparation - Patient not told to be fasting; improper or no instruction to patient on proper collection of specimen such as clean catch urine.

Ø  Patient injured during phlebotomy - Development of hematoma resulting in no specimen obtained for testing.

Ø  Requisition errors - Patient information missing, illegible, or on wrong patient; wrong tests ordered.

Ø  Patient identification - Patient incorrectly identified.

Ø  Labeling of specimen - Specimen not labeled or incorrectly labeled.

Ø  Preparation of specimen - Specimen centrifuged too long or not long enough; specimen placed in improper preservative.

Ø  Storage of specimen - Specimen not refrigerated or frozen as required or refrigerated when it should be at ambient temperature.

Ø  Shipment of specimen - Shipped at ambient temperature when it should have been shipped frozen; delay in shipment.

Ø  Accessioning process including preparation for analysis

Ø  Sorted into wrong batch; incorrect labeling.

Ø  Order entry - Incorrect data entered during manual entry of a test requisition.

Ø  Specimen sub-optimal - Not enough specimen for testing; visible hemolysis.

Ø  Contamination - Inadequate cleansing of venipuncture site resulting in contamination during blood culture collection.

Analytic Phase

Errors occur much less frequently in the analytic phase of laboratory testing than in either the preanalytic or postanalytic phases. The supposition of published studies on the error rate in this category is that the percentages remain low primarily because of:

Ø  The qualifications of testing personnel

Ø  Effectiveness of internal quality control programs and

Ø  External assessment practices which assist in identifying analytical errors and detecting possible sources.

Following is a list of examples of errors that may be encountered during the analytic testing activities. The list includes both human and instrumentation errors. While random errors (those that occur independently of the operator) may be encountered during the analytic phase, primarily listed are systematic errors. That is, errors those bias the measurement resulting from either instrument malfunctions or human mistakes.

Ø  Errors in quality control and verification of performance specifications.

Ø  Instrument malfunctions.

Ø  Calibration errors causing a direction of bias in results.

Ø  Manual pipetting errors.

Ø  Reagent errors.

Ø  Test interference caused by unsuspected antibodies.

Ø  Specimen interference i.e. failing to visually see sample was lipemic.

Ø  Math errors.

Ø  Staff errors in testing preparation and processing.

Ø  Inadequate staffing which may precipitate errors caused by fatigue.

Postanalytic Phase

Recently, significant attention has been focused on errors made during the postanalytic phase of laboratory testing and the impact errors made during this phase have on laboratory-related patient outcomes. Similar to the preanalytic phase, the postanalytic phase can be subdivided into those procedures that are within the laboratory, and those outside the laboratory; where the physician receives, interprets, and acts on the laboratory results. The examples listed below are limited to possible postanalytic errors that may occur within the laboratory and over which the laboratory has more control:

Ø  Laboratory results not verified before being reported.

Ø  Improper data entry or typing mistakes causing erroneous information to be reported.

Ø  Critical values not reported, or not reported in a timely manner.

Ø  Laboratory tests not reported or reported to the wrong health provider.(For example, poor communication to a patient's physician of the results of laboratory tests that are pending at the time of a patient's discharge.)

Ø  Lack of timeliness of reporting laboratory results (slow turnaround time).

Ø  Misinterpretation of an alphabetic flag in the result field (i.e. lower case "l" interpreted as the number "1".

Oral results misunderstood by receiving party- no "read back" requested to confirm that data was correctly received

Possible applications of Risk Management Procedures in the Medical Laboratory

• Patient Identification Errors

• Accession Errors

• Provision of new tests and services

Introduction to the Risk Management Process

Viewing risk management as a process helps set priorities and assists in ensuring a comprehensive risk management effort. There are several different approaches to the risk management process; the approach that is proposed in this course includes these five steps:

1.    Identify and analyze loss exposure.

2.    Consider alternative risk management treatments.

3.    Select what appears to be the best risk management treatment or combination of treatments.

4.    Implement the selected treatment(s).

5.    Monitor and improve the risk management program.

Identify and Analyze Loss Exposure

Risk management is the process by which the laboratory becomes aware of risk that can cause potential loss exposure. Loss could result from a variety of circumstances and, depending upon the circumstances, can be insignificant to catastrophic. Therefore, in addition to identifying the risk, it is also important to establish the severity of the risk by determining the probability of loss if the risk is not controlled. There are a variety of ways the laboratory can identify potential risks. The following methods are generally considered among the more effective methods.

Ø  Evaluating complaints from patients and clients

Ø  Reviewing incident reports

Ø  Evaluating deficiencies cited by accreditation or governmental  

inspections (external assessments)

Ø  Reviewing proficiency testing results

However, it is important to be sensitive to events or trends that may alert you to risk potential. For example, although continually monitoring the number of phlebotomies that are performed in a day may not be a normally effective method for evaluating risk, if there is a sudden staff shortage of phlebotomists or a sudden increase in hospital census, it may be worth evaluating the number of phlebotomies that are done because the risk potential may increase if the phlebotomy staff is overworked.

Failure Mode and Effect Analysis

Root cause analysis (RCA) is a method of error analysis that involves retrospective investigations. Error analysis, using a different conceptual strategy, may also involve prospective attempts to predict error modes.

One of the most commonly used prospective approaches is failure mode and effect analysis or FMEA. Root cause analysis is used primarily to examine the underlying contributors to an adverse event or condition. FMEA differs in that its primary use is to evaluate a process prior to its implementation. Its purpose is to identify ways in which a process might possibly fail with the goal being to eliminate or reduce the likelihood of such a failure (i.e., reduce risk).

In addition to describing a generic FMEA process, we will use an example specific to healthcare – HFMEATM – the Health Care Failure Mode Effects Analysis. This is an actual Risk Management tool that has been put into use in the VA system in 2001.

1. Create a map of the process, and use that to identify all hazards and harms that can occur at each step (a hazard is a potential source of harm, and hazards can result in multiple harms). We strive for a complete catalogue of all the possible hazards and harms. Typically this involves brainstorming by a team made up of the staff that actually performs the process.

2. Next, we assign a frequency or probability to each harm – estimating the likelihood that that any given outcome will occur. In some cases, this number is a ranking from 1 to 10, with 1 being very rare, and 10 being frequent. In the case of HFMEATM[3], this ranking isn't even a number, but is a general frequency (remote, uncommon, occasional, frequent):

Root Cause Analysis

Root cause analysis (RCA) is a structured study that determines the underlying causes of adverse events. 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.

Occurrences that may jeopardize patient safety must be investigated immediately and appropriate risk-reduction activities must be implemented. The most serious of these occurrences has been labeled by the Joint Commission as a sentinel event. A sentinel event is an unexpected event involving patient death or serious physical or psychological injury. A root cause analysis must be performed if a sentinel event occurs.
Another serious event that also requires investigation at the level of a root cause analysis is sometimes referred to as a near miss. A near miss is a process variation that did not result in patient death or serious injury, but a significant risk of one of these adverse outcomes was present and could occur if the same process variation was repeated.

Cause and Effect (Fishbone) Diagram Example

This type of diagram graphically helps identify and organize known or possible causes for a specific problem or area of concern.

In this theoretical example, the identified problem is a "near miss." Two units of RBCs were taken to the Dialysis unit for transfusion of two different patients. The first unit was hung by one clinical person and started just as another clinical person noticed that the unit that he/she picked up for transfusing another patient had the wrong identifying information. The blood was stopped immediately on the first patient.

Some of the benefits of constructing a "fishbone diagram" are that it:

Ø  Helps determine root causes using a structured approach.

Ø  Encourages group participation and utilizes group knowledge.

Ø  Indicates possible variations in a process.

Ø  Indicates areas where more data should possibly be collected.

The Fishbone Diagram

Examining Alternative Risk Management Treatments

Root cause analysis is a process for identifying factors that cause risks. It focuses primarily on systems and processes, not on individual performance. The process progresses from identifying causes to identifying potential strategies that could possibly be implemented to improve the system or activity (cause and effect). In other words, after determining what caused the risk in the first place the next step is to determine what can be done to stop the risk from happening in the future. This is referred to as loss prevention. Some examples of risk control treatments in loss prevention might include:

Ø  Staff education

Ø  Procedure revisions

Ø  Policy review

Selecting the best risk management treatments involves two steps. The first step requires that there be an attempt to forecast what effect or effects the suggested alternative risk treatments might have on the desired objective(s). The second step entails implementing one or more of the alternative treatments that not only meet the desired objective(s) but also meet the desired objective in a cost-effective manner.

Implement the selected treatment(s)

The selected alternative treatment or treatments are then implemented. Everyone who might be affected by the selected treatment(s) must be made aware of the implementation. The pareto chart is a useful tool during the implementation phase. It graphically summarizes and displays the importance of the cause or causes that have been identified in the fishbone chart and helps the laboratory staff determine which cause to focus on first.

Errors Related to Risk Management

When the need for root cause analysis arises, it is hoped that the investigative team will be receptive to all suggestions and proposals in addition to making a systematic analysis. Listed are three mistakes that commonly afflict the risk management process and consequently can affect positive outcomes. The risk control that should be applied is exposure avoidance.

Anchoring error: This term refers to the deliberative trap of allowing first impressions to exert undue influence on the risk analysis.

Confirmation bias: This is a tendency to focus on evidence that supports a working hypothesis rather than looking for evidences that supports an alternative solution.

Anchoring bias: This refers to the tendency to hold on to an initial solution even in the face of disconfirming evidence.

Pre-Employment Screening

Pre-employment screening is not an invasion of an applicant's private life. In a screening and credential verification program, the healthcare organization is seeking to confirm what an applicant has done in his or her professional career such as previous employment, criminal and civil records, credit history, driving records, educational credentials, and professional certifications. Potential employers are entitled to obtain job-related information in order to make the best possible hiring decision.

Healthcare organizations that fail to implement a risk management program, which includes pre-employment screening, could be eventually exposed to lawsuits, workplace violence, sexual harassment difficulties, theft, property damage, or loss of business. In addition to limiting these detrimental effects, other benefits of pre-employment screening may include:

Ø  Discouraging job applicants with falsified credentials from even applying.

Ø  Eliminating, to a degree, the uncertainty in the hiring process.

Ø  Demonstrating that the health care organization has taken reasonable steps in the hiring process; thus providing some protection in the event of a lawsuit.

Ø  Encouraging applicants to be op en and truthful on their applications and during the interview process.

Employee Competence Assessment

It is important that job-related performance standards be established for each position in the laboratory (e.g. medical laboratory scientist, medical laboratory technician, phlebotomist, and laboratory aide). The standards should be distinctly stated and clearly communicated (both in writing and verbally) to the employee so that the employee fully understands what is expected.

It is also important to remember that when performing an employee performance evaluation, an individual's performance must only be compared to the established performance standard.

If the employee's performance falls below an established performance standard, it should be clearly articulated to the employee where he/she needs to improve to meet the standard. The supervisor should then meet with the employee at established intervals to discuss whether the employee is making progress toward meeting the established standard.

In addition, it is important that supervisors understand how to conduct and properly document an evaluation. Documentation, however, should not be limited just to the annual or biannual evaluation review. Performance problems for all employees should be documented regularly. Apply policies consistently to all employees and in all situations; avoid inconsistent enforcement. Ensure that all personnel documentation is reviewed only by those individuals who have a "need to know." The review process is not to be a means for someone to publicly embarrass an employee.

To Conclude

Clinical laboratories perform many activities to reduce the risk of error. Most are done as “reactive” preventive activity. In current scenario clinical laboratories do not use the tools found helpful in risk management and time and skills of risk managers in incident investigation is not incorporated. Quality Management systems require application of preventive actions to reduce the opportunity for significant error. Tools established for assessing potential opportunities for risk would appear to fit preventive action needs. Laboratories can develop strategies to incorporate Risk Management techniques within the Quality Management system to prevent error

References:

1. ISO/DIS 31000 (2009). Risk management — Principles and guidelines on implementation. International Organization for Standardization.

2.  David Hillson; Ruth Murray-Webster (30 March 2007). Understanding and Managing Risk Attitude. Gower Publishing, Ltd. ISBN 978-0-566-08798-1.

3. http://en.wikipedia.org/wiki/Ishikawa_diagram

4. Safety aspects – Guidelines for the inclusion in standards ISO/IEC Guide 51: 1999” (Geneva: International Organization for Standardization, 1999)

5. CLSI. Laboratory Quality Control Based on Risk Management; Approved Guideline. CLSI Document EP23-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2011