Laboratory Administration & Management of Pathology Practices
Safety
Risk management
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PubMed Search: Risk management
Table of Contents
Definition / general | Essential features | Terminology | ICD coding | Risk identification | Risk assessment | Issue reporting | Risk treatment and prevention | Cultural attitudes towards risk | Surveillance | Overall risk management strategy | Diagrams / tables | Videos | Board review style question #1 | Board review style answer #1 | Board review style question #2 | Board review style answer #2Cite this page: Luu TD, Thao Doan T-P, Hassell LA. Risk management. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/labadminriskmanagement.html. Accessed December 4th, 2024.
Definition / general
- Risk in a laboratory context is defined by 5 factors: probability, outcome, significance, causal scenario and affected population; it refers to the likelihood of a laboratory error causing adverse consequences (Ann Saudi Med 2011;31:223)
- Risk management involves assessing risks and creating strategies to address them; it is a crucial part of the quality management system (QMS) in medical laboratories (Int J Health Care Qual Assur 2019;32:574, Cureus 2022;14:e32774)
Essential features
- Risk management includes
- Identifying potential risks associated with each phase (preanalytical, analytical and postanalytical) is especially useful for improving systems in pathology
- Assessing and reporting laboratory risks involves analyzing root causes, quantifying and prioritizing risks and ensuring accurate and timely error disclosure to patients
- Effective risk prevention, treatment and surveillance in laboratories require a combination of methods, systems and human factors to ensure consistency and quality
Terminology
- Diagnostic error is either failing to offer a timely and accurate explanation of a patient's health problem or to communicate that explanation (Adv Anat Pathol 2018;25:124)
- Failure mode and effect analysis (FMEA) involves identifying potential failure modes and assessing their effects to reveal possible issues and evaluate the impact of proposed changes on system design (Cureus 2024;16:e53393)
- Laboratory information system (LIS) / laboratory information management system (LIMS) are computerized systems that collect, process and store information produced by the laboratory (Accred Qual Assur 2023;28:167)
- Risk priority number (RPN) is determined by multiplying scores for severity (S), which assesses the potential harm from an error; likelihood of occurrence (O), which evaluates how probable it is for the risk to result in an error; and likelihood of detection (D), which measures the chances of detecting the error (Cureus 2022;14:e32774)
- Root cause analysis (RCA) asserts that every event may have multiple causes and utilizes a systematic approach to identify flaws, aiming to improve performance and achieve consistent outcomes (Cureus 2024;16:e53393)
- Human factor reliability analysis (HRA) is used to assess the impact of human factors on the reliability and security of a system (IEC 31010: Risk Management - Risk Assessment Techniques, 2nd Edition, 2019)
- Standard operating procedures (SOPs) are essential written step by step instructions designed to guide laboratory personnel in carrying out specific procedures accurately and consistently (PLoS Negl Trop Dis 2016;10:e0005053, WHO: Laboratory Quality Management System Handbook [Accessed 23 September 2024])
ICD coding
- ICD-10
- Z91.89 - other specified personal risk factors, not elsewhere classified
- Z57.9 - occupational exposure to unspecified risk factor
- Z60.9 - problem related to social environment, unspecified
- Z77.0 - contact with and (suspected) exposure to hazardous, chiefly nonmedicinal, chemicals
- Z77.1 - contact with and (suspected) exposure to environmental pollution and hazards in the physical environment
- Z77.2 - contact with and (suspected) exposure to other hazardous substances
- Z77.9 - other contact with and (suspected) exposures hazardous to health
Risk identification
- Not having a standard system for classifying errors may lead to differences in how errors are defined and managed, making it harder to handle and study them such as
- Contexts: research, nonresearch
- Impact: categories for the level of harm, ranging from no harm to harm
- Root causes: human factor or nonhuman factor
- Testing phase in which the error occurred is related to either the preanalytical, analytical or postanalytical phase
- Identifying potential risks according to testing phase (preanalytical, analytical and postanalytical) is especially useful for improving systems in pathology, specifically including
- Specimen: risks can arise during procedures such as sample collection, labeling, transportation and preparation
- System and method: risks relate to equipment and protocol used in laboratory
- Reagent and waste: risks can cause immediate harm or long term health issues through fire, explosions, poisoning and corrosion
- Environment: laboratories face multiple hazards, including biological, chemical and radioactive sources, with potential health impacts like toxicity and carcinogenic effects
- Personnel: human factors are crucial at every stage, from sample collection to result processing
- Other risks
- Results reporting
- Incorrect sending of results to the customer can occur due to falsification or negligent error
- Data loss can happen during receipt, transfer, processing and storage
- Even with data handling software, data can be violated or modified by error or deceit
- Impartiality / confidentiality: IT should identify risks from its activities, stakeholder relationships (top management representatives, clients, service providers, etc.) and staff interactions
- Digitalization
- Modern laboratories are becoming more reliant on computers and various electronic devices for their administrative tasks and analytical processes
- Possible risks involve the loss of data and the chance of unauthorized access to or alteration of raw data files produced by laboratory equipment
- There is also a risk of incorrect input of information into LIMS or quality standards for digital forensics
- Financial risk
- Cost pressures may lead to use of substandard methods or reagents
- Ignorance of costs or revenues
- Improper budgetary planning may lead to inability to update, replace equipment and sustain supplies
- Market risks may impair revenue stream
- Inability to retain staff due to shifts in employment market (Adv Anat Pathol 2018;25:124, Forensic Sci Int 2020;316:110486, Cureus 2022;14:e32774, Accred Qual Assur 2023;28:167, Forensic Sci Int Digit Investig 2020;32:200905)
- Results reporting
- Using questionnaires of good laboratory practices could identify risks (see risk identification questionnaire based on good laboratory practices table) (Cureus 2022;14:e32774)
Risk assessment
- Errors in pathology can vary from nonharmful to harmful and distinguishing them from adverse events is challenging
- Preanalytical errors, common yet often overlooked, can impact multiple patients due to batch processing issues
- Effective management and disclosure require robust systems for handling preanalytical errors and ensuring proper communication and accountability (Adv Anat Pathol 2018;25:124)
- Root cause analysis (RCA): there are various approaches to finding the root cause of risk (see Causal analysis)
- 5 whys: ask "why" 5 times to identify the final problem
- Fishbone diagram: includes 6 categories (personnel, material, method, machine, mission and management) to identify problem causes and plan actions with team input
- Failure mode and effect analysis (FMEA): identifies failure modes and their consequences, aiding proactive risk management and continuous improvement to enhance process, product and system reliability and quality
- Other methods
- Fault tree analysis (FTA): shows the problem like a tree, where the branches represent different causes and the main cause is found by looking at these branches
- Scatter chart employs dots: useful for finding relationships (whether positive, negative or none) between different factors
- Pareto chart: using both a line graph and a bar chart shows important problems based on their combined effects
- Define, measure, analyze, improve and control (DMAIC): this means identifying and measuring the problem, looking at the collected data to find the main causes, taking steps to improve and putting control measures in place
- 8 dimensional (8D) problem solving process: each D stands for a step in finding the main cause, creating solutions and stopping the problem from happening again (Cureus 2024;16:e53393, Int J Med Inform 2021;156:104584)
- Risk quantification: using the FMEA tool involves calculating the risk priority number (RPN) by assessing scores for severity, likelihood of occurrence and likelihood of detection (see scores for risk quantification table)
- RPN = S x O x D (range: 1 - 1,000) (Int J Prev Med 2018;9:7, Cureus 2022;14:e32774)
- Risk prioritization: the aim is to identify effects caused by risks, requiring attention to both RPNs and additional questions, as different outcomes may have the same RPN
- How critical is it in compromising patient safety?
- How imminent is the error?
- What impact could it cause immediately and in the future on the reputation of the laboratory?
- What are the expected financial losses to the laboratory?
- Does the risk have the potential to recur within the period of nonattention when it has not received priority? (Cureus 2022;14:e32774, Clin Chim Acta 2009;404:75)
Issue reporting
- For effective incident reporting, it should be precise, based on facts, comprehensive, descriptive and trustworthy; for instance
- Basic information: general details about the situation
- Location or surroundings: the place where it happened
- People impacted: those who were affected by the incident
- Injuries and how serious they are: types of injuries and their severity
- Witnesses: people who saw what happened
- Treatment given: medical care provided to the injured
- Damage to property and equipment: harm done to items or tools
- Events that took place: what happened during the incident
- Actions of those involved: what the people present did during the situation (Safety Culture: Incident Report Guide [Accessed 23 September 2024])
- Error disclosure to a patient for pathologists: it is important but challenging, requiring stratification based on the harm (physical and emotional) and the ability to meet reasonable care, which is divided into 4 groups
- No error (no harm and reasonable care): no disclosure to patient required
- Nonharmful error / near miss (no harm but reasonable care)
- Adverse event (harm but reasonable care): RCA / quality improvement efforts and consider discussion with patient
- Harmful error (harm and unreasonable care): create a disclosure team that could consist of individuals from risk management, patient relations, the healthcare quality department, patient safety officers, hospital or departmental leadership and peer support staff; conduct RCA / quality improvement efforts and inform the patient about the error using the framework below (acronym: AIR IT)
- Apology: an effective apology empathetically including personal or systems accountability
- Information: details related to the occurred event accurately
- Root causes: the primary and underlying reasons for the event, human mistakes and systemic factors (avoid conjecture)
- Impact: consequences for the quality of care and end results
- Targets for improvement: modifications to the process to minimize the risk of repetition and strategies for follow up
- Effective disclosure involves open communication, addresses legal and ethical aspects, improves organizational learning and requires personal connection and understanding of the error
- Despite challenges, solutions like simulation training and clinician pairing can help (Adv Anat Pathol 2018;25:124)
Risk treatment and prevention
- After completing the risk assessment stage, the risk shall be treated with options such as
- Avoiding risk or removing the risk source: when identified, risks should be completely eliminated as they may have direct effects on the reputation of the organization, such as RPN ≥ 100 or RPN < 100 with severity ≥ 9
- Taking or increasing risk to pursue an opportunity, changing the likelihood, changing the consequences: risks are repetitive and can never be completely eliminated as they are inherent to an existing system of operation
- Sharing the risk (through contracts, insurance)
- Maintaining the risk with a documented decision (Cureus 2022;14:e32774, Ann Saudi Med 2011;31:223, Accred Qual Assur 2023;28:167)
- Insurance in practice: pathologists need various insurance policies to manage professional / personal risks; therefore, securing appropriate coverage is crucial for addressing these diverse risks, namely
- Health, life and disability insurances suitable to handle personal risks based on personal needs and conditions
- Professional liability or medical malpractice insurance provides financial protection against claims of malpractice or professional negligence
- Errors and omissions insurance includes claims related to mistakes, neglect or failures in providing medical services, not covered by standard malpractice insurance
- Directors and officers liability insurance protects directors and officers of a pathology practice from employment practices liability, including harassment, discrimination suits and sometimes fiduciary liability (Wagar: Laboratory Administration for Pathologists, 2nd Edition, 2019)
- There are appropriate means to cope with detailed laboratory risks, specifically
- Specimen
- Key approaches include
- Creating clear, documented processes
- Improving training for staff
- Automating tasks where feasible
- Checking quality measures
- Boosting communication and teamwork among professionals
- Modern technologies like LIS, LIMS and 1D / 2D barcode reading automate data collection and tracking, significantly reducing manual handling and errors in specimen identification
- Regularly evaluating the storage capacity to handle sample volumes effectively and take necessary actions when capacity is exceeded (JAMIA Open 2020;3:530, N Engl J Med 2003;348:2526, Clin Chem Lab Med 2007;45:720, Accred Qual Assur 2023;28:167)
- Key approaches include
- System and method
- In house methods must be fully validated
- Laboratory general procedures based on international protocols with the latest version and use of certified analytes
- Laboratory internal and external quality control procedures
- Internal quality control involves daily checks using standards, control charts, blind samples and equipment checks, while managing and updating quality documents, addressing threats / opportunities and controlling corrective actions
- External quality control uses blind samples from external providers to independently verify test accuracy, demonstrate laboratory competence and identify issues in methods, equipment or personnel, necessitating thorough review and adherence to handling instructions (Crit Rev Clin Lab Sci 2022;59:586, Clin Chem Lab Med 2006;44:750, Accred Qual Assur 2023;28:167)
- Reagent and waste
- Chemical management plan: store chemicals by category in well ventilated areas, separate flammable from nonflammable materials, conduct frequent stock checks and use wooden trays for transportation and personal protective equipment (PPE)
- Waste disposal: recycle and dispose of chemicals correctly, such as neutralizing them before disposal
- Safety measures: install smoke alarms, fire extinguishers, surveillance cameras and emergency equipment such as showers and eyewash stations, while ensuring marked escape routes and the use of PPE
- Procedures and training: implement detailed procedures and clear instructions and provide appropriate training to personnel (Clin Biochem 2021;95:15, Accred Qual Assur 2023;28:167)
- Environment
- Risk estimates should be integrated into the analytical framework
- Executives must apply risk management theories to ensure safe and competent laboratory operations
- Laboratories need to assess potential errors and outline steps to detect and prevent them
- Proactive measures should be taken to avoid future adverse events (Arch Pathol Lab Med 2006;130:633, Clin Chem Lab Med 2006;44:750, Accred Qual Assur 2023;28:167)
- Testing personnel
- Human factor reliability analysis (HRA) assesses how human factors impact system reliability and security
- To mitigate human error, effective training and continuous supervision are recommended
- Automated systems, such as LIMS, can reduce human intervention and improve accuracy (Clin Chem Lab Med 2006;44:750, Clin Biochem 2017;50:864, Clin Chim Acta 2009;404:68, IEC 31010: Risk Management - Risk Assessment Techniques, 2nd Edition, 2019, Accred Qual Assur 2023;28:167)
- Other risks
- Results reporting
- Laboratories should implement multilevel data control procedures
- Data handling software must be verified and protected against tampering
- Integrating these processes into a LIMS can reduce manual errors, ensure data integrity / record failures and corrective actions
- Combining a LIMS with a web based reporting system can also speed up result reporting, improving client satisfaction and trust
- Documenting decision rules for test conformity declarations helps prevent false results (Clin Chem Lab Med 2006;44:750, Meas Tech 2011;53:1182, Accred Qual Assur 2023;28:167)
- Impartiality / confidentiality
- Laboratories need policies to protect confidentiality and handle breaches
- Upper management should lead and provide confidentiality training
- Confidential information must be securely stored with restricted access
- Electronic documents should be on secure networks
- Physical records must be protected from unauthorized access
- Effective communication helps avoid malpractice litigation
- HIPAA regulates electronic health records, secures protected health information (PHI), limits disclosure and requires patient consent, making compliance crucial for minimizing regulatory and malpractice risk (Accred Qual Assur 2017;22:103, Wagar: Laboratory Administration for Pathologists, 2nd Edition, 2019, Accred Qual Assur 2023;28:167)
- Digitalization
- Creating backups is a common method for preserving digital data
- Routine backups may not adequately protect critical data from forensic laboratories so adopting updated practices like digitized ledgers with global custody offers more secure and verifiable data tracking (Forensic Sci Int 2020;316:110486, Forensic Sci Int Digit Investig 2022;33:300976, Accred Qual Assur 2023;28:167)
- Financial risk
- Up to date cost information and strategic planning are essential for pricing services, managing finances and ensuring sustainability
- Top management must actively seek financial resources to meet the laboratory's human and infrastructure needs (Accred Qual Assur 2023;28:167)
- Results reporting
- Specimen
- Standard operating procedures (SOPs)
- SOPs are essential written instructions that ensure laboratory personnel perform procedures accurately and consistently
- SOPs maintain quality across all aspects of the QMS by connecting with elements such as organization, personnel, equipment, procurement, process control, biosafety and corrective / preventive actions
- SOPs are considered part of the documentation along with policies, processes and forms
- Purpose and benefits of SOPs
- Consistency: SOPs ensure uniform procedures, leading to reliable and reproducible results
- Accuracy: by providing detailed instructions, SOPs help reduce the likelihood of errors and variability in experimental outcomes
- Quality of data: SOPs contribute to high quality data by standardizing methods and techniques, which is vital for credible and trustworthy results
- Harmonization of practices: SOPs help align laboratory practices with established protocols, minimizing discrepancies between different operators and laboratories
- Error reduction: clearly defined procedures reduce user errors by guiding personnel through each step, which enhances the overall reliability of the results
- Training: SOPs serve as valuable training tools for new laboratory personnel, providing a clear reference for proper procedure execution
- Regulatory compliance: SOPs facilitate adherence to study protocols, regulatory requirements and international standards, such as those from the International Organization for Standardization (ISO) or U.S. Food and Drug Administration (FDA)
- International standards: SOPs ensure that laboratory practices meet international standards, fostering global consistency in scientific and clinical research
- Detailed outline for creating a well structured SOP (see detailed outline for creating a well structured SOP table)
- Results of the process should be recorded and reported throughout the organization
- This reporting provides information for decision making, enhances risk management activities and facilitates interaction with stakeholders
- All the above steps should be monitored and reviewed to ensure and improve the quality and effectiveness of risk management (Cureus 2022;14:e32774, Ann Saudi Med 2011;31:223, Accred Qual Assur 2023;28:167)
Cultural attitudes towards risk
- To ensure safety in laboratories, it is essential to
- Share safety knowledge with students or colleagues
- Properly label reagents, equipment and samples
- Use PPE appropriately
- Store and handle reagents, materials and samples correctly
- Decontaminate work areas and sterilize materials after use
- Dispose of solid and liquid waste in appropriate containers
- Regularly inspect laboratory safety conditions
- Wash hands with proper detergent after work
- Maintain accurate records of laboratory practices
- Adhere to all safety protocols to protect individuals and the environment
- Ensure the laboratory environment is safe for student practice
- Receive regular training on laboratory safety (Microbiol Insights 2023;16:11786361231174414)
Surveillance
- Surveillance helps to continuously evaluate the effectiveness of completed risk management activity (see scheduled quality assurance activities table) (Cureus 2022;14:e32774)
Overall risk management strategy
- Education and training programs
- Risk management plans should outline the training requirements for employees, including initial orientation, continuous professional development, yearly evaluations, competency assessments and training for particular incidents
- Patient and family complaints
- To improve patient satisfaction and reduce the likelihood of legal action, the risk management plan should detail the processes for recording and handling patient and family complaints, including response times, staff duties and required actions, while ensuring effective communication of this information
- Objectives and measurements
- Risk management plans should explicitly outline the objectives and advantages of the healthcare risk management strategy, including specific targets aimed at minimizing liability claims, sentinel events, near misses and overall risk related expenses
- Plan should also require comprehensive reporting on measurable and actionable information
- Communication strategy
- While encouraging open and spontaneous discussions is essential, the healthcare risk management plan should specify communication protocols, including methods for addressing risks and identifying relevant stakeholders, along with documentation of subsequent actions and follow up activities and clearly define reporting obligations to departments and executive leadership
- Plan should also promote a safe, blame free environment and offer options for anonymous reporting
- Backup plans
- Risk management plans should include backup plans for major failures and disasters, like problems with electronic health records (EHR), security breaches and cyberattacks; they should also prepare for emergencies like disease outbreaks, extended power outages and events such as terrorism or mass shootings
- Reporting procedures
- Each healthcare organization must implement an accessible system for recording, categorizing and monitoring potential risks and adverse events, along with protocols for required reporting
- Response and management (NEJM Catalyst: What Is Risk Management in Healthcare? [Accessed 26 September 2024])
- Healthcare risk plans must incorporate cooperative systems for managing reported risks and events, covering immediate response, follow up, documentation and prevention of recurrence
Diagrams / tables
Contributed by Tung D. Luu, M.D.
Process of risk management
5 whys strategy
Fishbone strategy
Guidelines for error disclosure to patients
Images hosted on other servers:
Risk identification
questionnaire
based on good
laboratory practices
Scores for risk quantification
Scheduled quality assurance activities
Detailed outline for creating a well structured SOP (PLoS Negl Trop Dis 2016;10:e0005053, WHO: Laboratory Quality Management System Handbook [Accessed 23 September 2024], Berte: QMS02-A6 - Quality Management System, 6th Edition, 2013)
| Title |
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| Purpose |
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| Scope |
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| Responsibilities |
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| Materials and equipment |
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| Procedure | Step by step instructions: detailed, sequential instructions on how to perform the procedure; each step should be clear, concise and easy to follow; it may include
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| Safety and compliance |
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| Documentation and records |
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| Troubleshooting |
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| References |
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| Revision history |
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Videos
Fundamentals of laboratory safety:
introduction to laboratory safety
Introduction to laboratory informatics:
life of a result - life of a specimen flow overview
Introduction to laboratory informatics:
life of a specimen - communicating results
Introduction to laboratory informatics:
life of a specimen - data quality
Introduction to laboratory informatics:
life of a specimen - what is a LIMS?
Basics of risk management
Board review style question #1
Prolonged specimen transportation time led to ischemia and resulted in whole tissue necrosis, precluding a definite diagnosis. According to the error disclosure recommendation, what steps should be taken in this scenario?
- Assemble a disclosure team, perform a root cause analysis (RCA) and disclose the issue to the patient using the AIR IT framework, including an apology
- Document the issue and request a new specimen from the patient, focusing on internal process improvements
- No disclosure is required; only improve specimen transportation protocols and conduct quality improvement efforts
- Perform an RCA and discuss the issue with the patient but do not assemble a disclosure team
Board review style answer #1
A. Assemble a disclosure team, perform a root cause analysis (RCA) and disclose the issue to the patient using the AIR IT framework, including an apology. This is a harmful error because the prolonged transportation could damage the specimen, potentially leading to incorrect diagnoses and inappropriate treatment for the patient. Answer C is incorrect because the issue involves significant harm to the patient, necessitating formal disclosure using the AIR IT framework. Answer D is incorrect because while RCA and patient discussion are important, not assembling a disclosure team misses a critical step in effectively managing and disclosing harmful errors. Answer B is incorrect because it does not address the need for formal disclosure of the harmful error to the patient, which is required in such situations.
Comment Here
Reference: Risk management
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Reference: Risk management
Board review style question #2
When faced with an image showing a bad immunohistochemistry (IHC) stain and the absence of internal positive control staining, according to the standard operating procedures (SOPs) structure, where should one first look for instructions on how to address this issue?
- Documentation and records
- Materials and equipment
- Procedure
- Troubleshooting
Board review style answer #2
D. Troubleshooting. This section is specifically designed to help identify and resolve problems encountered during the IHC process. It provides targeted guidance for dealing with issues like poor staining and missing internal positive controls. Answer B is incorrect because this section typically provides information on the materials and equipment required for the IHC procedure as well as ensuring you have the right tools, which does not address issues related to poor staining or missing controls directly. Answer C is incorrect because this section details the steps for performing IHC but does not include solutions for addressing problems encountered during staining. Answer A is incorrect because this section focuses on how to document and record the procedure and results, not on fixing issues with staining or controls.
Comment Here
Reference: Risk management
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Reference: Risk management
