Medical Error Prevention Patient Safety

Copyright and License Notice for PDF Courses

LabCE courses are provided in PDF format for the sole use of LabCE subscribers.

Distribution to non-subscribers is prohibited in every form, including electronic and print. Do not make multiple copies of this PDF file.

If you are an individual subscriber, you are the only person authorized to use this PDF file. Please do not redistribute it to others inside or outside your organization. Instead, please contact LabCE about obtaining an institutional subscription.

This Copyright and License Notice is part of the Terms of Service for LabCE. If you have any questions, please contact us.

LabCE retains all copyright to this course and all material contained therein.

Page 1 of 29

Copyright 2013 by MediaLab, Inc. All rights reserved.

Medical Error Prevention: Patient Safety

Authors: Catherine Otto, PhD, CLS(NCA); Garland Pendergraph, PhD, JD, SM(ASCP) Reviewer: Barbara Cebulski, MS, MLS(ASCP)CM

Page 2 of 29


Course Instructions

Please proceed through the course by clicking on the blue arrows or text links. Use the table of contents to monitor your progress. Your progress will be saved automatically as you proceed through the course, and you may later continue where you left off even if you use a different computer. You may encounter practice questions within the course, which are not graded or recorded.

Page 3 of 29


Course Info

This course carries the following continuing education credits:

● P.A.C.E. Contact Hours: 2.00 hour(s) Course Number: 578-012-11

● Florida Board of Clinical Laboratory Science CE - Medical Errors: 2.00 hour(s)

Page 4 of 29


Six aims of the Institute of Medcine (IOM) to improve health care quality.

State of Health Care Quality

Most medical interventions produce positive outcomes. Everyone expects to give and receive effective medical care. These expectations are routinely met by the health care community.

However, a 2000 publication from the Institute of Medicine, (IOM), To Err is Human: Building a Safer Health System, reported that between 44,000 and 98,000 individuals died while hospitalized in the United States in 1997 due to medical error. Deaths occurred due to medication errors, nosocomial infections, and other failures in the delivery of care.

For patients who do not die, yet experience a medical error during their hospital stay, at the minimum they experience repetitive testing and procedures and extended hospital stay. These increase overall costs to health insurance companies and individuals; at the worst, they may leave a patient with a comorbidity or disability. Using unnecessary resources to address these errors reduces opportunities to provide care for uninsured individuals, add new technology, or support new programs.

Although there has been a greater focus upon reducing errors in hospital settings, medical care delivered in outpatient and other non-hospital settings are not immune from error prone systems.

It has been several years since the IOM published To Err is Human, but the IOM's messages and recommendations continue to be opportune. Health care practitioners and patients may be more aware of these recommendations today, however, serious adverse events, including wrong site surgeries, medication errors, and nosocomial infections, continue to occur in health care organizations throughout the country.


Six Institute of Medicine Aims

In response to the publication of To Err is Human, the IOM published strategies in Crossing the Quality Chasm to reduce errors in health care and improve its quality. The IOM identified six aims for health care systems of the 21st century. Health care systems should be:

● Safe ● Effective ● Patient-centered ● Timely ● Efficient ● Equitable


Six Institute of Medicine Aims (continued)

Page 5 of 29


1. Health care that is safe "avoids injuries to patients from the care that is intended to help them."* Patients should not be harmed while receiving health care from events such as nosocomial infections, missed diagnosis, or other iatrogenic sequelae resulting from interaction with any aspect of the health care system.

2. Effective health care provides services based upon scientific knowledge to those who would benefit from that care and refrains from providing care to those who are not likely to benefit. Health care that is effective avoids underuse and overuse of services.

3. Patient-centered health care is care that is delivered in a manner that is "respectful of and responsive to individual's preferences, needs, and values." The principle of this aim is that it is patients' values that guide all clinical decisions, not those of the health care provider.

4. Health care that is timely "reduces waits and harmful delays for those who receive and those who provide care." Patients should receive care at the time when it would be most helpful in identifying the cause of their condition, followed by receiving interventions needed to treat those conditions.

5. Health care that is efficient avoids waste. This includes waste of equipment, supplies, ideas, energy and time, for both patients and health care practitioners.

6. Heath care that is equitable "does not vary in quality because of attributes such as gender, ethnicity, geographic location and socioeconomic status."

*Reference: Committee on Quality of Health Care in America. Crossing the Quality Chasm, A New Health System for the 21st Century. Washington, DC: National Academy Press. 2001.


Improving Effectiveness

Problems in health care quality have focused upon medical errors--harm to patients that resulted due to experiences with the health care system. However, safety--doing no harm; is only one aspect of the broad term that "patient safety" encompasses. Because the IOM has defined health care quality as "The degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge," its six aims include more than avoiding or reducing harm in the health care delivery process. Health care that is effective is one that does not perform more tests than necessary to diagnose and treat patients' conditions, yet appropriate and adequate tests are performed in order to diagnose and treat conditions in a timely manner. Scientific evidence is critical to identify appropriate tests and treatments so that overutilization, underutilization and misutilization of health care processes is limited.

Page 6 of 29



Focusing upon Patient-Centered Care and Timeliness

Patient-centered care focuses on ensuring that patient values guide decisions. For practitioners, patient-centered care encompasses these actions:

● Coordinating the services patients receive ● Communicating in a manner that patients understand ● Alleviating anxiety ● Reducing patients' pain ● Involving patients' family members in decision making if they have the role of caregivers

Timeliness is critical throughout the entire health care delivery process--beginning with time waiting on hold to make an appointment or to speak to a clinician, to waiting for an appointment, and receiving results of diagnostic procedures.

Health care practitioners experience similar waiting during the course of delivering care to their patients.


Preventing Medical Errors Through Patient Involvement

Patients and their families should be encouraged to become active participants in their health care and "speak up" when they have questions and concerns. In recent years, patients have become more aware and have been more cognizant of potential errors in their care.

Through the efforts of the Joint Commission in its "Speak Up" campaign, patients are encouraged to:

● Pay attention to the care they receive; making sure they receive the right treatments. ● Educate themselves about their diagnosis, medical tests, and treatment plans. ● Ask a trusted family member or friend to be their advocate when they cannot "speak up" for themselves. ● Know their medications and why they take them. ● Choose hospitals, clinics, surgery centers, and other health care organizations that undergo rigorous onsite

evaluation. ● Participate in all decisions about their health care and treatment.

Reference: Speak up: Help prevent errors in your care. Joint Commission website. Available at: http://www.jointcommission.org/topics/speakup_brochures.aspx. Click on "Topics" then "Speak Up." Accessed November 14, 2013.


Focusing upon Efficiency and Equity

Inefficiency wastes resources and results in rework. It can be improved by automating processes that are repetitive,

Page 7 of 29


such as using information systems; or it can be improved by limiting the amount of rework that is performed by addressing each situation as it arises.

The role of equity in the health care delivery system is to improve the health of the entire population and to provide that care without discrimination. The quality of care delivered to each individual should not vary due to personal characteristics such as gender, geographic location, and socioeconomic status.


Ungraded Practice Question

Which of the following are included in the Institute of Medicine (IOM) aims to improve the quality of health care in the United States?

Health care systems should be:

More than one answer is correct. Please select all correct answers



Which of the following are included in the Institute of Medicine (IOM) aims to improve the quality of health care in the United States?

Health care systems should be:

gfedc Centralized

gfedc Efficient

gfedc Effective

gfedc Profitable

gfedc Timely

gfedc Patient-centered

gfedc Physician-centered


gfedc Centralized

gfedc Efficient

gfedc Effective

gfedc Profitable

Page 8 of 29


Feedback

According to the IOM, health care systems of the 21st century should strive to be safe, effective, patient-centered, timely, efficient and equitable.

IOM aims within the context of quality clinical laboratory services.

Clinical Laboratory Services and Safety

The key to identifying whether clinical laboratory services provide safe health care is to determine the harm that ensues as a result of inappropriately delivered clinical laboratory services. Safe health care with respect to clinical laboratory services requires the reduction of opportunities for harm to the patient.

Harm can be a false-positive or false-negative test result, or it can be an adverse event as a result of an inappropriately performed venipuncture. Harm can also be defined as a delay in diagnosis or a patient receiving inappropriate treatment.


How might patient harm result from each of these problems related to clinical laboratory services? Consider your answer and then click on the defined problem to reveal the potentially harmful result(s) of the action or condition.

gfedc Timely

gfedc Patient-centered

gfedc Physician-centered

False-positive (laboratory test result is reported as positive when it is really negative) or false-negative test result (laboratory test result is reported as negative when it is really positive).

Page 9 of 29



How might patient harm result from each of these problems related to clinical laboratory services? Consider your answer and then click on the defined problem to reveal the potentially harmful result(s) of the action or condition.

Feedback


Clinical Laboratory Services and Effectiveness

Clinical laboratory services that are effective provide testing that benefits all those who receive it. It requires performing testing only when the sample is of adequate and of appropriate integrity--including timing of the collection. It requires using evidence (scientific knowledge) to establish how often a test should be performed during a hospitalization and removing antiquated and ineffective testing methodologies from the testing menu.

Increased turnaround time

Inappropriately performed venipuncture or skin puncture

False-positive (laboratory test result is reported as positive when it is really negative) or false-negative test result (laboratory test result is reported as negative when it is really positive).

Increased turnaround time

Inappropriately performed venipuncture or skin puncture

Page 10 of 29



Clinical Laboratory Services and Patient-Centered Care

Associating clinical laboratory services with patient-centered care may seem difficult as laboratory workers usually do not interact with patients. However, the first step to improving this aspect of health care quality is to shift the focus from specimens to patients. Although phlebotomists' efforts focus upon individual patients and the number they interact with on a daily basis, the remainder of medical laboratorians examine their services with respect to numbers of samples and billable tests. New methods need to be developed to measure numbers of patients served by clinical laboratory services.


Clinical Laboratory Services and Timeliness

Page 11 of 29


Measuring timeliness of clinical laboratory services is ingrained in medical laboratorians. Timeliness needs to be expanded to encompass more than the portion of the total testing process that occurs within the walls of the clinical laboratory. For example, a more accurate description of timeliness begins with the time from test order entry and also identifies how long it routinely takes for action to be taken after test results are sent to a clinician.


Clinical Laboratory Services and Efficiency

Efficiency with respect to clinical laboratory services is best described as avoiding repeated steps in the total testing process and decreasing rework. Ensuring that laboratory test results are available when clinicians need the results helps to insure that unnecessary repeat testing is not ordered nor performed.

Page 12 of 29



Clinical Laboratory Services and Equity

Equity in providing clinical laboratory services is best described as ensuring that services are not preferentially provided to one group of individuals over others.



Which of the following best defines "effective clinical laboratory services?"

Please select the single best answer

nmlkj Counting patients served instead of number of samples

nmlkj Using evidence to identify the best test to detect or diagnose a condition

nmlkj Determining how quickly laboratory tests are performed

nmlkj Avoiding repeated steps in the total testing process

Page 13 of 29




Which of the following best defines "effective clinical laboratory services?"


Feedback

Effective clinical laboratory services can be defined as, "Using evidence to identify the best test to detect or diagnose a condition."

Counting patients served instead of number of samples may improve patient-centered care.

Determining how quickly laboratory tests are performed is a measure of timeliness.

Avoiding repeated steps in the total testing process results in efficiency.

Recognizing problems (errors) that could occur in each phase of the total testing process

Medical Errors

Medical errors are mistakes medical professionals make in patient testing, care, or treatment. Categories of medical errors include:

● Failures of planned actions ● Mistakes of execution ● Use of wrong plans to achieve outcomes

There are two types of medical errors: Errors of commission Errors of omission

Errors of commission are medical errors involving wrong actions. Mislabeling a test specimen, drawing a blood sample from the wrong patient, or incubating a test at an incorrect temperature are all errors of commission.

Errors of omission are medical errors that occur when an individual fails to act. In the laboratory setting, errors of omission include such things as omitting a reagent in a test, failing to communicate a critical test result, failing to collect a timed test sample at the correct time.

nmlkj Counting patients served instead of number of samples

nmlkj Using evidence to identify the best test to detect or diagnose a condition

nmlkj Determining how quickly laboratory tests are performed

nmlkj Avoiding repeated steps in the total testing process

Page 14 of 29



Factors that Contribute to Medical Errors


Factors that Contribute to Medical Errors

Feedback


Total Testing Process

Medical errors are possible at any phase of patient care-- preanalytic, analytic, or postanalytic phase.

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.

Monitoring processes in all three phases of testing are key to ensuring patient safety and reducing the possibility of medical errors related to laboratory testing.


Multi-tasking

Automatic actions (automaticity)

Suboptimal work environment

Multi-tasking

Automatic actions (automaticity)

Suboptimal work environment

Page 15 of 29


Safe Preanalytic Component of Total Testing Process

A study that was published in 2002 concluded that the majority of laboratory errors occur in the preanalytic phase of testing.*

Steps in the preanalytic 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:

● Patient preparation ❍ Patient not told to be fasting ❍ Improper or no instruction to patient on proper collection of specimen such as clean catch urine

● Patient injured during phlebotomy ❍ Development of hematoma ❍ Nerve or tissue damage caused by improper technique or wrong-site venipuncture

● Requisition errors ❍ Patient information missing, illegible, or on wrong patient ❍ Wrong tests ordered

● Patient identification ❍ Patient incorrectly identified ❍ Specimen not labeled or incorrectly labeled

● Specimen integrity ❍ Not enough specimen for testing ❍ Visible hemolysis ❍ Inadequate cleansing of venipuncture site resulting in contamination during blood culture collection ❍ Specimen centrifuged too long or not long enough ❍ Specimen placed in improper preservative ❍ Specimen transported at the wrong temperature (eg, specimen that should be placed on ice immediately

after collection is transported at ambient temperature) ● Shipment of specimen

❍ Shipped at ambient temperature when it should have been shipped frozen ❍ Delay in shipment

● Order entry ❍ Incorrect data entered during manual entry of a test requisition

*Reference: Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory medicine. Clin Chem. 2002;48:691-698. Available at: http://www.clinchem.org/cgi/content/full/48/5/691#T2B. Accessed November 19, 2013.


Safe Analytic Component of Total Testing Process

Automation has improved the accuracy and improved the safety of the analytic component of the total testing process. However, it is still important to examine this portion of the process.

Following are 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 that bias the measurement resulting from either instrument malfunctions or human mistakes.

● Errors in quality control and verification of performance specifications

Page 16 of 29


● Instrument malfunctions ● Calibration errors causing a direction of bias in results ● Manual pipetting errors ● Reagent errors ● Specimen interference (eg, lipemia or hemolysis) ● Calculation errors ● Inadequate staffing which may precipitate errors caused by fatigue


Safe Postanalytic Component of Total Testing Process

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. Examples of errors that could occur in the postanalytic phase include:

● Laboratory results not verified before being reported. ● Improper data entry or typing mistakes causing erroneous information to be reported ● Critical values not reported, or not reported in a timely manner ● 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) ● Lack of timeliness of reporting laboratory results (slow turnaround time) ● Misinterpretation of an alphabetic flag in the result field (eg, 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 ● Abnormal test not recognized by the clinician ● Failure of clinician to order appropriate follow-up testing ● Failure of clinician to communicate test results and next steps to patient and family

In the postanalytic phase, the test result becomes information that the clinician must act upon. The test information and the action have an effect on the patient--either to benefit or harm the patient's health.

Tracking what occurs after laboratory test results are sent to clinicians is a new concept for clinical laboratorians. However, this mindset is important to truly measure the safety of clinical laboratory services.


Patient-Centered Preanalytic Component of Total Testing Process

Clinical laboratory test information is only as good as the sample collected. Providing education regarding the hows and whys of the process is respectful to the patient; it will improve sample integrity, and it may prevent medical errors. Allow time:

● For patients to ask questions ● To share information that is important to the sample collection process ● To describe post-venipuncture self-care information.

Page 17 of 29


This will enhance the patient-centered focus of clinical laboratory services.


Patient-Centered Analytic Component of Total Testing Process

In addition to tracking the number of tests performed or the billable tests performed, consider adding the number of patients who were served on a daily, weekly, and monthly basis in each of the clinical laboratory disciplines. Depending upon the laboratory and hospital information system, this may be tracked via accession numbers or encounter numbers. The very nature of collecting this type of data will change the clinical laboratorian's focus from specimen to patient. How many people received a laboratory intervention that day, that week, or that month?

Collecting other data such as the number and the subsequent rate of abnormal tests and critical test results will also provide valuable prevalence information for the population of patients served by the laboratory.


Patient-Centered Postanalytic Component of Total Testing Process

Immediately communicating critical test results to the clinical person who is in charge of the patient's care is a postanalytic patient-centered component of the total testing process. It is also important if the results are given verbally (ie, by phone) to go one step further and ask the person receiving the results to read back the patient information and test result(s).


Timely: Reduce Wait Times and Harmful Delays

Clinical laboratorians have been measuring and reporting turnaround times for decades. This has been valuable because tests have different levels of importance with respect to timeliness given patient's clinical situation or nature of the specimen. However, we do not have a standard definition of how to measure turnaround time. Is turnaround time defined as the time from when the clinician orders the laboratory test to the time when the clinician takes action on the test results? Or is it the time from when the sample is collected to the time the laboratory test result is reported to the clinician? Or is it something else?

Defining turnaround time as the time when the clinician orders the laboratory test to the time when the clinician takes action on the test results measures the total testing process. If clinical laboratorians are to improve the quality of health care by improving the quality of clinical laboratory services, determining the timeliness of action upon our services is an appropriate indicator to monitor. One method to calculate this would require auditing the medical records of a specified number of abnormal test results.

Page 18 of 29



Timely: Reduce Waits and Harmful Delays (continued)

There is extraordinary value in measuring turnaround times (TAT). However, it is important to be selective with respect to which tests to monitor. Consider monitoring TAT for tests performed for patients in surgery, intensive care units, emergency department and oncology. These areas customarily use laboratory test results immediately upon receipt. Thus, outliers for their respective TATs represent circumstances in which patient safety may be compromised.



Identify the phase of the total testing process in which each of these errors occurs.

Select the correct match for each item from the drop-down box



Identify the phase of the total testing process in which each of these errors occurs.

6Choose Incorrectly handled critical test value

6Choose Wrong test ordered

6Choose Incorrectly performed instrument calibration

6Choose Incorrecly collected sample

6Choose Incorrectly performed venipuncture

Select the correct match for each item from the drop-down box

6Choose Postanalytic Incorrectly handled critical test value

6Choose Preanalytic Wrong test ordered

6Choose Analytic Incorrectly performed instrument calibration

Page 19 of 29


Feedback

Preanalytic- Incorrecly collected sample, wrong test ordered, incorrectly performed venipuncture

Analytic- Incorrectly performed instrument calibration

Postanalytic- Incorrectly handled critical test value

Outcomes of patient safety errors with respect to clinical laboratory services.

Outcomes of Laboratory Services

Outcomes can be described as "what happened as a result of an action." The goal of health care is to improve the health of individuals who seek its services.

Considering this from a positive point of view, outcomes of laboratory services include:

● Living ● Getting well ● Improving health and function ● Being cured ● Receiving a proper diagnosis ● Going into remission ● Receiving a treatment or medication adjustment ● Being discharged from the hospital

Negative patient outcomes of laboratory services include:

● Inappropriate medical treatment ● Inappropriate medication adjustment ● Incorrect diagnosis ● Delayed diagnosis ● Delayed treatment

All of these negative outcomes require investigation. An unexpected event that has resulted in death or serious injury (physical or psychological) or an event that was averted, but may have resulted in death or serious injury (often referred to as a "near miss") must be investigated by performing a root cause analysis.


Reporting of Errors

6Choose Preanalytic Incorrecly collected sample

6Choose Preanalytic Incorrectly performed venipuncture

Page 20 of 29


A near miss should be handled non-punitively, if possible. One reason is so that personnel will freely report these occurrences without fear of being punished or fired. Another reason is that a process problem is usually due to either a process flaw or a managerial error. Perhaps sufficient safeguards are not in place to prevent an error, or perhaps personnel are not being assessed for the competencies they need to perform the job safely.

An environment of blame encourages a culture of secrecy about medical mistakes. Mandatory reporting laws have not overcome this secrecy, and they do not encourage efforts to find ways of avoiding errors. Error reduction requires a commitment from the community to recognize and acknowledge that medical errors most often indicate systems problems, not people problems.


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.


Root Cause Analysis (continued)

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:

● Staff education ● Procedure revisions ● Policy review


Root Cause Analysis Example

Page 21 of 29


One of the tools that can be used when performing a root cause analysis is the cause-and-effect diagram, which is often referred to as a "fishbone diagram" because of its appearance.

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 tranfusion 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:

● Helps determine root causes using a structured approach. ● Encourages group participation and utilizes group knowledge. ● Indicates possible variations in a process. ● Indicates areas where more data should possibly be collected.


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.

Page 22 of 29




A patient event occurs that results in a "near miss" (an event that was averted, but may have resulted in death or serious injury). The error was caught in time before serious injury occurred. Which of the following is an appropriate response to improve the process involved and patient safety?




A patient event occurs that results in a "near miss" (an event that was averted, but may have resulted in death or serious injury). The error was caught in time before serious injury occurred. Which of the following is an appropriate response to improve the process involved and patient safety?

nmlkj Perform a root cause analysis, document investigation, and implement appropriate risk-reduction processes.

nmlkj Be thankful that the patient was not seriously injured and hope it doesn't happen again.

nmlkj Fire the person who was responsible.


Feedback

The appropriate response to a near miss is to perform a root cause analysis, document the investigation, and implement appropriate risk-reduction activities.

A near miss may be an isolated incident, but it is important to perform a root cause analysis to understand what may have contributed to the error and what steps should be taken to prevent it from happening again, perhaps with a more dire outcome.

A near miss should be handled non-punitively, if possible. One reason is so that personnel will freely report these occurrences without fear of being punished or fired. Another reason is because a problem is usually due to either a process flaw or a managerial error. Perhaps sufficient safeguards are not in place to prevent an error, or perhaps personnel are not being assessed for the competencies they need to perform the job safely.

nmlkj Perform a root cause analysis, document investigation, and implement appropriate risk-reduction processes.

nmlkj Be thankful that the patient was not seriously injured and hope it doesn't happen again.

nmlkj Fire the person who was responsible.

Page 23 of 29


Sources of data to identify errors and patient outcomes

Monitoring Laboratory Processes to Prevent Medical Errors

Monitoring laboratory processes is a proactive approach to prevention of medical errors and assurance of patient safety. Safety, efficiency, and timeliness of clinical laboratory services can be defined and measured.

Select one or two processes for each phase of testing (preanalytic, analytic, and postanalytic). To identify areas to monitor for improvement, consider focusing upon those systems or disease processes in which clinical laboratory test information has the greatest impact. Or, consider those processes that are high volume, high cost, or high risk. The laboratory could also monitor those circumstances in which clinical laboratory test information is used immediately (ie, stat turnaround times). When information must be used immediately or without other data, it will have a more significant impact on the patient and may be more prone to error.


Data sources to identify errors

Variation in the total testing process is a valuable place to examine opportunities to improve clinical laboratory services. Incident reports describe a variation in process and from that report, opportunities for process modification to improve patient safety will be identified. Complaints from patients, clinicians and other health care practitioners provide similar information to make improvements in clinical laboratory services.

Outliers identified in turnaround time studies provide valuable information with respect to breakdowns in processes. Instead of disregarding outliers as just an aberration, use those situations as opportunities to examine how it occurred and identify methods to reduce those types of errors in process.



Which of these sources may be useful for identifying patient safety problems?


gfedc Cost per test

gfedc Complaints from patients

gfedc Outliers or variation in any monitored process

gfedc Incident reports

Page 24 of 29




Which of these sources may be useful for identifying patient safety problems?


Feedback

Incident reports describe a variation in process and from that report, opportunities for process modification to improve patient safety will be identified. Complaints from patients, clinicians and other health care practitioners are also sources that may identify patient safety problems. Outliers identified in turnaround time studies provide valuable information with respect to breakdowns in processes.

Evaluation of the cost per test may be useful for identifying inefficiency, but would not be a source of information for identifying patient safety issues.

Patient Safety Goals

The Joint Commission National Patient Safety Goals 2014 for Clinical Laboratories

The Joint Commission is an independent agency that accredits health care organizations and programs. Since 2001, the Joint Commission has published Patient Safety Goals with the intent of reducing medical/health care errors by focusing on patient safety issues.

The Joint Commission National Patient Safety Goals, effective January 1, 2014, that apply to clinical laboratories are:

● Use at least two patient identifiers when providing laboratory services. ● Report critical results of tests and diagnostic procedures on a timely basis to the right person. ● Comply with either the current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines or the

current World Health Organization (WHO) hand hygiene guidelines. Set goals for improving hand hygiene procedures.

These are not new goals for the laboratory to follow. Patient identification procedures and communication of laboratory test results were included in the first list of goals in 2003. Reducing health care-associated infections has been a goal since 2004.

Reference: The Joint Commission National Patient Safety Goals.

gfedc Cost per test

gfedc Complaints from patients

gfedc Outliers or variation in any monitored process

gfedc Incident reports

Page 25 of 29


http://www.jointcommission.org/standards_information/npsgs.aspx Accessed November 19, 2013.


National Patient Safety Goal: Identify Patients Correctly

Two patient identifiers should be used at any stage of the laboratory total testing process. This is of particular importance when collecting a patient sample. Examples of acceptable patient identifiers are:

● Individual's full name ● An individual-specific identifier, such as

❍ birth date ❍ hospital number ❍ medical record number ❍ other assigned unique identification number

If a patient is able to respond, it is also important to ask the patient to state his or her name.

Specimens must be labeled in the presence of the patient.



Which of the following is NOT an acceptable patient identifier to use prior to performing venipuncture procedures?




Which of the following is NOT an acceptable patient identifier to use prior to performing venipuncture procedures?

nmlkj Patient's complete name

nmlkj Birth date

nmlkj Hospital identification number

nmlkj Patient's room number

Page 26 of 29



Feedback

Patient's location in the hospital is not a unique identifier.

A patient's full name, birthdate, and hospital identification number are all acceptable forms of patient identification. However, remember that at least two forms of identification are needed. For an outpatient, name and birthdate could be used. For an inpatient who has a unique hospital or medical record number, it is best to use this number also as a positive identifier.


National Patient Safety Goal: Improve Staff Communication

Effective communication of critical results of laboratory tests to a licensed caregiver in a timely manner is required for this National Patient Safety Goal. The procedure must define critical results of laboratory tests, by whom and to whom critical laboratory test results are communicated, and the acceptable time between availability and reporting of critical laboratory test results. Following the development of the laboratory's "Communication of Critical Test Results" procedure, it must be monitored for compliance and timeliness.

Critical laboratory test results that are given over the phone must only be given to a clinical person (person in charge of the patient's care). The person who receives the result should be asked to read back the information that is given to verify that it was heard correctly. The person who reported the result, the person who was notified, and the date and time of notification should be documented along with the test result.


National Patient Safety Goal: Prevent Infection Through Hand Hygiene

Proper hand hygiene reduces the risk of health care-associated infections, which reduces the number of medical errors. Hand hygiene is a term that means cleansing of the hands by either washing with soap and water or by applying an antiseptic agent to the hands, such as an alcohol-based hand rub. The Centers for Disease Control and Prevention (CDC) has posted on its website guidelines from the World Health Organization (WHO) for proper hand hygiene techniques. These guidelines are included on this page as resources. They can also be found on the CDC website at: http://www.cdc.gov/handhygiene/Basics.html. Accessed November 19, 2013.

nmlkj Patient's complete name

nmlkj Birth date

nmlkj Hospital identification number

nmlkj Patient's room number

Page 27 of 29


Conclusion

Measurement and the Improvement of Clinical Laboratory Services

Although clinical laboratory services have been measuring the quality of its services with proficiency testing and accreditation programs for decades, there are always areas for improvement that can be realized by examining the total testing process with respect to errors and outcomes and improving effectiveness and patient-centeredness of our services. An analytical approach provides a foundation to examine laboratory processes with a goal of preventing medical errors.

References

References

Barr JT, Schumacher GE. Outcomes Assessment of Therapeutic Drug Monitoring: System and Patient Considerations in Schumacher GE. Therapeutic Drug Monitoring. Norwalk, CT: Appleton & Lange 1995, pp. 191-236.

Clinical and Laboratory Standards Institute (CLSI). Continual Improvement; Approved Guideline. 3rd ed. CLSI document QMS06-A3. CLSI. Wayne, PA: 2011.

Handwashing techniques.pdf [click to view / print] Adobe Acrobat PDF file

Alcohol-based hand rub technique.pdf [click to view / print] Adobe Acrobat PDF file

Clinical and Laboratory Standards Institute (CLSI). Quality Management System: A Model for Laboratory Services; Approved Guideline. 4th ed. CLSI document QMS01-A4. CLSI. Wayne, PA: 2011.

Committee on Quality of Health Care in America. To Err is Human, Building a Safer Health System. Washington, DC: National Academy Press. 2000.

Committee on Quality of Health Care in America. Crossing the Quality Chasm, A New Health System for the 21st Century. Washington, DC: National Academy Press. 2001.

Hand hygiene basics. The Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/handhygiene/Basics.html. Accessed November 19, 2013.

McDowell I, Newell C. General Health Status and Quality of Life in McDowell I, Newell C. Measuring Health, A Guide to Rating Scales and Questionnaires. New York: Oxford University Presss. 1996, pp.380-492.

The Joint Commission National Patient Safety Goals. http://www.jointcommission.org/standards_information/npsgs.aspx Accessed November 19, 2013.

Page 28 of 29


Page 29 of 29


Documents

Medical Error Prevention Patient Safety