Top 10 Medical Laboratory Mistakes and How to Prevent Them from Happening in Your Lab

“Mistakes Happen” is a common phrase in the US, but some mistakes are much more serious than others. That’s certainly the case when we turn our attention to healthcare, and in particular the medical laboratory, where even the most minor mistake can directly impact the well-being of a patient.

Diagnostic Errors and Preventable Deaths

Before listing the most common mistakes that occur within a medical lab, it’s first important to get a sense of scale. 

It’s estimated by some that medical error is the third most common cause of death in the US, with diagnostic-error accounting for 25% of those deaths. Just how many deaths actually occur each year due to medical error remains an open debate, as estimates range from 160,000 to 400,000 depending upon which published report you reference. 

We can dive ever deeper into the numbers with a report published by the National Institutes of Health. The report, titled the Measurement of Errors in Clinical Laboratories, concluded that 80 to 90% of all diagnoses are made based on laboratory test results and diagnostic (laboratory) errors are reported at a frequency of 0.012 to 0.6% for all diagnostic tests. 

Now measure that error rate against the estimated 7 billion clinical lab tests performed in the US each year and it’s clear that thousands of preventable deaths are occurring annually due to diagnostic error.  

The report also noted what we already know full well, and that’s that the diagnostic testing process is very complex. It involves various procedures, equipment, technology, and human expertise, and all of these elements need to come together seamlessly if we are to ensure accurate, precise, and timely diagnosis and treatment decisions for patients.

More Variables to Consider

Now that we’ve established that mistakes happen in the laboratory, it’s important to also mention a few other variables. The frequency and types of mistakes can vary widely depending on several factors, like the expertise of the clinical lab or pathology group’s personnel, the complexity of the tests performed, the effectiveness of laboratory information systems, and the quality control measures deployed by the lab.

Also noteworthy is the fact that the medical field as a whole is highly regulated, and that medical labs follow stringent requirements from regulatory bodies like the College of American Pathologists (CAP), the Clinical Laboratory Improvement Amendments (CLIA), and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Also, when inevitable mistakes do happen, they are investigated thoroughly to improve lab processes and prevent the same mistake from happening again.

Common and Preventable Laboratory Mistakes 

Thanks to high levels of complexity and massive volume, yes, some medical laboratory mistakes are inevitable. However, just as testing volumes continue to grow annually, one can argue that the technology and innovation present within advanced laboratory information systems (LIS) - the informatics workhorses that support lab workflow management - is keeping pace by providing LIS software solutions that not only flag diagnostic errors but also help prevent them from happening in the first place.

Here’s a list of common and preventable lab errors that can happen when clinical labs and pathology groups fail to put a premium on lab information systems (also known as pathology lab software) that excel in efficiency and compliance.

Data Entry Errors 

Ideally, medical labs would utilize modern laboratory information systems that digitally accept requisitions into the lab, but some labs still rely on manual transcriptions of test orders. This creates an opening for human error in the preanalytical stage. 

Prevention Strategies for Data Entry Errors

• Implement internal systems that require double entry of critical data (entered twice and cross-checked for inconsistencies).

• Have another team member do an independent verification of data entries.

• Integrate software that can assist by automatically flagging potential errors before they go downstream. 

• Periodically perform random audits of the department to identify workflow gaps and correct errors.

• Utilize input masking for data validation. An input mask is a string of characters that indicates the format of valid input values (examples: telephone numbers, zip codes, dates and times ).

• Incorporate a user-friendly order entry interface that intuitively simplifies data entry tasks (example: order entry interface drop-down menus).

Patient Identification Errors

Mistakes in patient identification can have severe consequences, causing specimens to be misattributed or mixed up. Given that each specimen must not only be correctly linked to a patient but also tracked through various stages of processing and testing, ensuring accurate identification is critical. A single error in this chain can result in misdiagnosis, incorrect treatment, and even worse, harm to the patient.

Prevention Strategies for Patient Identification Errors

• Assign a unique ID to every specimen as well as each specimen derivative (like tissue slides or paraffin blocks). This prevents mix-ups and ensures that each unique ID is able to be traced back to the original specimen and case.

• Implement a coding system that uses specific colors for visual differentiation of specimen types and urgency levels. 

• Utilize a two-point verification protocol that requires staff to verify patient data with two distinct data points (examples: name and date of birth).  

• Implement a robust and automated specimen tracking system to follow each specimen (and its derivatives) through every stage of processing. 

• Utilize lab software that triggers alerts when discrepancies or mismatches in patient data and specimen IDs are discovered. 

• Perform random audits and quality checks to make sure specimen tracking protocols are being followed. 

• Establish Standard Operating Procedures (SOPs) that clearly outline each step of the specimen handling and identification process.

• Develop a positive work environment that encourages the reporting of any mistakes and treats miscues or near misses as a learning opportunity.

• Encourage regular communication and feedback loops within the team to share knowledge and make improvements.

Mislabeling

This is a simple and preventable mistake at the preanalytical stage that can lead to delayed treatment and dire consequences. Like data transcription errors, mislabeling can largely be prevented by using a lab information system that supports barcode labels and the assignment of unique IDs for every specimen.

Prevention Strategies for Mislabeling

• Use the technology found in an advanced laboratory information system (LIS) to track specimens throughout their testing journey.

• Implement a barcoding system for both specimen containers and patient information.

• Establish a simple and standardized labeling procedure that’s easy for staff members to follow.

• Make comprehensive and ongoing training of staff a priority so the entire team is highly proficient and well prepared to effectively minimize errors.

• Implement a two-person verification system (example: one person collects the specimen and another person verifies the labeling information before moving forward with processing).

• Introduce a checklist as part of the lab workflow to ensure that all of the necessary steps in specimen collection and labeling are successfully completed before moving on to the next stage.

• Encourage open communication among team members so all staff members feel comfortable reporting potential errors or concerns without hesitation.

• Employ an adequate number of trained staff members (especially during peak hours) to handle the workload and minimize stress.

• Conduct a thorough investigation to get to the root cause whenever a mislabeling incident does occur.

• Develop a culture of continuous improvement and use feedback from mislabeling incidents to update and strengthen prevention protocols.

Specimen Swapping 

This is similar to mislabeling in that it’s very preventable with the right pathology lab software solution. Modern LIS systems support error-free specimen handling and the secure tracking of specimens from receipt through the recording of test results, which prevents the inadvertent swapping of samples and/or test results during processing.

Prevention Strategies for Specimen Swapping

• Use at least two unique patient identifiers (examples: name, date of birth, and medical record number) to verify the patient’s identity at every step of the testing process.

• Implement barcode or radio-frequency identification scanning (RFID) at multiple points in the testing workflow to ensure that the specimen and patient information match up.

• Separate the collection area for a particular test or department from others to prevent the  mixing up of specimens.

• Seal specimen containers with tamper-proof seals and regularly inspect the seals to make sure no tampering has taken place.

• Conduct regular training sessions that reinforce proper specimen identification techniques and procedures.

• Establish clear and open communication channels between specimen collection points and the lab.

• Install surveillance cameras in both specimen storage and processing areas to monitor staff activity and identify any irregular actions.

Contamination 

Any deviation from a clinical lab workflow or proper hygiene can introduce dangerous contaminants that put test results into question. High volume labs that rely on batch testing of specimens are most at risk, as are labs that lack proper training. Regular quality control (QC) checks and ongoing prevention protocol training can help protect the lab from contamination.  

Prevention Strategies for Contamination

• Make sure all staff members use proper hygiene, wear appropriate personal protective equipment (PPE), and regularly disinfect work surfaces.

• Avoid potential cross-contamination by restricting the movement of contaminated materials or equipment into designated clean areas.

• Regularly monitor and maintain good air quality and guard against the build up of dust, particles, or other potential contaminants.

• Establish a stringent cleaning and disinfection schedule for all lab surfaces, instruments, and other tools within the laboratory.

• Implement strictly followed protocols for the disposal of hazardous waste and contaminated materials.

• Perform regular maintenance and calibration checks on all lab instruments to ensure that they don’t malfunction and contaminate specimens.

• Maintain records that detail all procedures, including specimen handling and instrument maintenance.

• Conduct regular health checks for all lab personnel to identify and mitigate any potential sources of contamination (examples: infections or illnesses).

• Develop and communicate clearly understood protocols and conduct regular drills that reinforce how to respond to spills, accidents, or other urgent issues that could lead to contamination.

Expired Reagents

Reagents have a limited shelf life because their chemical properties change over time. Therefore, the use of expired reagents can adversely affect diagnostic test results. To avoid this mistake, it’s very important for labs to follow the manufacturer's guidelines regarding both reagent storage and reagent expiration dates. 

Prevention Strategies for Expired Reagents

• Regularly update and review the lab’s inventory records to identify and remove all expired reagents from the stock.

• Clearly label all reagents with their expiration dates plainly visible and easily accessible.

• Train lab staff to always take the reagents from the back of the room or shelf, ensuring older stock is always pulled and utilized first.

• Establish regular communications with the lab’s reagent suppliers to receive notifications from them about any upcoming expirations.

• Add software that’s built to track reagent expiration dates and issue alerts when it’s time to order more reagents.

• Conduct regular audits of what reagents are in stock to identify any expired items.

• Maintain detailed records and documentation of all purchased reagents, their usage, and their expiration dates.

• Appoint specific personnel the responsibility of monitoring expiration dates and overseeing timely reagent replacements.

Improper Storage 

Every sample has specific storage requirements. Failure to adhere to the requirements put forth by regulatory bodies can lead to a change in a sample’s composition and distorted test results. To prevent this, lab managers should build regular monitoring and quality checks into all storage protocols.

Prevention Strategies for Improper Storage

• Label all storage shelves, cabinets, and refrigerators to clearly indicate what items should be stored in each area.

• Regularly monitor and record temperatures in storage areas to ensure that what’s being stored remains within the recommended temperature range.

• Use humidity control systems if necessary to prevent moisture-related damage to any items in storage.

• Maintain good ventilation in storage areas to prevent any buildup of odors or fumes.

• Store all chemicals and hazardous materials in accordance with all regulations and safety guidelines.

• Conduct regular inspections of storage areas to detect any signs of leaks or contamination.

• Be sure to separate all incompatible materials to prevent hazards such as accidental reactions.

• Use security cameras and alarms to prevent unauthorized access and potential tampering.

• Make sure all specimens and reagents are packaged and sealed properly before going into storage.

• Develop and clearly communicate protocols for what actions should be taken to handle spills, leaks, or other emergencies in storage areas.

• Maintain accurate records of storage conditions, inventory, and inspection reports.

Improper Instrument Calibration 

Laboratory instruments need to be calibrated regularly to ensure that the readings they produce are accurate and reliable. Proper documentation of these calibration checks by qualified personnel helps ensure that the diagnostic results produced can be trusted.

Prevention Strategies for Improper Instrument Calibration

• Set up a regular calibration schedule for all lab instruments and base the schedule on the manufacturer's recommendations and regulatory requirements.

• Develop and communicate standard operating procedures for instrument calibration, outlining all steps and procedures.

• Assign calibration as a regular task for qualified technicians and give them the resources to stay current on the latest techniques and technologies.

• Regularly verify the accuracy of certified reference materials (CRMs) to ensure reliability of all calibration processes.

• Maintain certificates of calibration for reference and to demonstrate lab-wide transparency.

• Implement routine QC checks using all known standards and controls to verify accuracy.

• Consider investing in an automated calibration system that can standardize the process (and reduce potential human error).

• Keep a logbook near each instrument that indicates its calibration status and any upcoming calibration schedule.

• Address any suspected malfunctions and irregular readings promptly to maintain instrument performance integrity.

• Use business management software to schedule and track all calibration activities.

Neglecting Quality Control

Medical laboratories administer regular QC checks to help them identify and then correct any errors found within the analytical process. By identifying patterns and emerging trends through ongoing QC data analysis, labs can maintain the quality and accuracy of all test results. 

Prevention Strategies for Neglecting Quality Control

• Assign a quality manager the responsibility of overseeing and enforcing all quality control processes within the lab.

• Conduct regular training and implement education courses for lab personnel that highlight the importance of quality control.

• Develop clear and straightforward SOPs that detail all lab QC processes.

• Maintain accurate records of all QC activities.

• Participate in external testing programs to compare your lab’s proficiency and performance against other labs.

• Implement internal QC procedures (example: running control samples on a regular basis) to monitor the accuracy of the lab’s analytical processes.

• Conduct a thorough investigation for any QC failures or variances from the expected analytical results.

• Conduct regular maintenance and calibration checks on all lab instrumentation.

• Encourage all staff members to immediately report any concerns or issues related to quality control.

Inadequate Training

The importance of specialized training of lab personnel cannot be overstated. Highly trained staff can be relied on to correctly implement procedures and maintain quality whereas a lack of proper training can expose the lab to reliability and efficiency issues that can directly impact patient safety.  

Prevention Strategies for Inadequate Training 

• Develop structured and comprehensive training programs for all lab personnel that cover standard operating procedures, safety protocols, and instrument operation. 

• Provide enhanced training modules tailored to specific roles and responsibilities within the lab. 

• Pair new hires with experienced staff members who can provide guidance and mentorship, answer questions, and teach proper techniques.

• Support staff members with resources for attending workshops, conferences, and other training opportunities so they can stay updated with the latest techniques and technologies.

• Conduct skills assessments and evaluate competency levels for all lab personnel regularly.

• Introduce and utilize interactive training techniques such as simulations and group discussions to reinforce continuous staff improvement.

• Rotate staff members through different departments to cross-train and broaden their knowledge base and overall expertise.

• Periodically review all training records to ensure staff compliance and identify staff members who may require additional training.

• Build a supportive environment where staff members are encouraged to seek help and ask questions.

How Advanced LIS Systems Improve Laboratory Efficiency and Patient Safety

Advanced laboratory information systems (LIS) like LigoLab Informatics Platform expertly manage all lab information (patient and specimen data, plus test results). They also automate or simplify complex lab processes (like sample management, quality control, and compliance) that would otherwise leave the organization vulnerable to diagnostic errors that put test results into question. 

Going further, the LigoLab platform is unique in that it offers a single, embedded suite of LIS software applications designed to improve laboratory performance at the department level, the case level, and the specimen level. The platform is highly configurable and comprehensive, supporting pathology groups and clinical laboratories that specialize in every testing discipline, including:

• Anatomic Pathology
• Biochemistry
• Genomics
• Hematology
• Microbiology
• Molecular Diagnostics
• Serology
• Toxicology

The platform also includes modules for lab revenue cycle management (RCM) and direct-to-consumer lab testing (DTC), making LigoLab the only LIS company with an all-in-one lab informatics solution.

For labs interested in modernizing and efficiently scaling their businesses, the LigoLab platform offers not only the latest in technological advantages, but also pricing options to fit any budget.

To learn more about our pricing, click on the link below.

LigoLab’s Tiered Pricing Model for its LIS Platform Delivers a Tailored Fit and Maximum Value

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