Most people will experience at least one diagnostic error in their lives—including errors in lab tests in medical laboratories. A tiny error can lead to mistakes like mixing up a specimen and wrongly identifying a patient—with potentially catastrophic results.
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One requirement to help prevent errors like this from happening is putting a good, solid laboratory quality management system in place. Obviously, quality should be a high priority for your company.
The quality management requirements for laboratories in life sciences are extensive and touch on everything from equipment to customer service. W
With a firm understanding of the 12 essentials of quality management in laboratory environments, you'll be able to confidently lead your medical services team to new levels of excellence and avoid potentially life-threatening mistakes.
Quality Management in Laboratory Environments: The 12 Essentials
In a laboratory, it’s essential to follow and maintain a stringent quality control and quality management process. If it’s not adhered to properly, your laboratory risks losing its accreditation from regulatory bodies. Your laboratory QMS should cover all aspects of your processes and procedures. The model for the following 12 essentials is from the is from the Clinical and Laboratory Standards Institute (CLSI) and ISO 15189.
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Life science professionals take these 12 tenets very seriously because the cost of quality issues is so high. “Not fully implementing the 12 essentials of quality could lead to issues in the laboratory such as treatment complications or unnecessary treatment, delayed diagnosis, poor patient outcomes, increased cost in time and work, and unnecessary follow-up diagnostic testing,” said Tom Zafred, owner of Biomed Systems and Laba, a biobank management system.
1. Organization
The laboratory needs to be organized around a formal quality management system that supports consistent procedures. The management team and quality unit play an integral role in a quality-driven culture, along with structures for monitoring ongoing quality.
2. Personnel
Capable, qualified staff members are the single most important asset to a laboratory. Training, motivation, and engagement are key parts of the quality management system. You also need to document all of your training processes within your quality management system.
3. Equipment
Every piece of equipment used in the laboratory must be maintained to operate safely. Also, laboratories need to monitor how equipment is installed, which suppliers provide the equipment, any calibration processes, and when the equipment needs to be replaced to maintain the highest possible quality.
4. Purchasing and Inventory
Properly managing the supply chain is critical to ensure that raw inputs and other supplies are consistently high-quality. Inventory activities should verify that materials and supplies are stored in a way that protects integrity. Make sure you purchase inventory from suppliers who also follow a quality management system.
5. Process Control
Process control encompasses QC processes for testing, including:
- Collection
- Handling
- Method Verification
- Process Validation
If you're struggling with process control, design control software can dramatically improve internal efficiencies. Within the software, you can document all processes related to each step of quality control, such as the testing required for verification and validation or internal audits.
6. Information Management
The laboratory produces many forms of information, including QC test results, maintenance reports, and other data. Along with that, the lab processes patient information such as medical exams, results, and more. This data needs to be managed in a way that ensures all information is accurate, secure, confidential, and accessible to individuals with the right privileges, such as lab managers and leadership.
7. Documents and Records
Documents are a similar concept to information management, and there’s a significant overlap between these categories. One of the most essential lab documents is standard operating procedures (SOPs) to create a standard for each process. Documents need to be available at the point of work, maintained, accurate, and secure. Finding the right document management software should be a mission-critical focus for any growth-oriented life sciences company.
8. Occurrence Management
An “occurrence” is any error or non-conformance. A QMS software can help you detect these issues and facilitate investigations to discover the root cause and prevent reoccurrence. A laboratory QMS can also assist you if you’re going through an audit, as it’s much easier to document these occurrences and what you did to fix them.
9. Assessment
Assessment involves comparing laboratory performance to internal standards for quality or external data sets, such as industry benchmarks. Assessments include the activities of lab or QC managers, internal auditors, or external inspectors.
10. Process Improvement
A quality management system should support the continuous improvement of laboratory processes. Components of the QMS which support improvement can include quality assurance, quality control, and CAPA (occurrence management). We recommend investing in training management software to build and activate major improvements to internal processes.
RELATED READING: 12 Questions to Ask Before Buying an eQMS
11. Customer Service
Customer service is the ultimate goal of a laboratory. A laboratory’s QMS should support operations that consistently provide a positive customer experience through the production of consistently high-quality products or other missions. The laboratory needs to understand the customers and their needs and use customer feedback for improvement.
12. Facilities and Safety
Laboratories need a comprehensive set of procedures and standards to ensure a safe, secure, and clean environment. This includes physically securing the lab, containment procedures for hazards, worker safety, and ergonomics.
The Role of Software in Laboratory Quality Management
ISO and the CLSI don’t specify exactly how laboratories should maintain control over quality. They simply define a quality management system as “coordinated activities to direct and control an organization with regard to quality.” But in practice, achieving the 12 essentials of quality requires purpose-built software.
A laboratory quality management system needs all 12 of the essentials to support consistently high-quality operations, and systems to ensure these elements are working in sync. If your QMS is missing several elements, such as document control or physical security, the entire system can easily crumble. Similarly, if your QMS hits all the basics but you can’t coordinate between the essentials by understanding the bigger picture of quality trends or root causes, you’re at risk of error.
Software isn’t strictly required by ISO standards or regulatory agencies, but it makes creating and maintaining a QMS much simpler. The right software can help you avoid having to reinvent the wheel by building a QMS from the ground up. Maintaining coordinated quality processes with paper systems can lead to poor visibility and human error.
Qualio is the first cloud-based QMS for life sciences laboratories, built specifically in accordance with ISO and FDA best practices. It includes all the essentials to help fast-growing lab startups and scale-ups create a solid quality baseline. Learn more about our solution here.
August 2, 2022Chemical pathologyLab Tests The principles of quality assurance, quality control, and quality management are bases for good laboratory results and workings. Every test in the laboratory gives a result. To be sure about the accuracy of the result is not possible until it is verified by some means. It is the quality control that will give confidence about the result. This is the duty of the technicians to be sure about the accuracy of the test result.Quality assurance:
Quality assurance:
Quality assurance pillars
- Quality assurance is vital to the patients, and this will need:
- Quality can be assessed and monitored.
- Quality program development.
- Quality control improvement.
- Quality control is one of the components of quality assurance. Quality assurance will check the entire testing process and will check quality regularly.
- Quality can be assessed, monitored, and it can be improved.
Quality control
- It will ensure the accuracy and reproducibility of the lab’s various tests.
- QC checks the particular source of errors, estimates the magnitude of the errors, and alerts the laboratory personnel that quality has deteriorated.
- Quality control results will be acceptable when these are in the acceptable range of the error limits.
- Quality control (QC) results are unacceptable when these results show excessive errors and are out of the range.
- Quality control goals are:
- Accuracy.
- Precision.
- The total error of the chemical method.
Ideal properties of QC materials are:
- QC material should resemble human serum, plasma, blood, urine, and cerebrospinal fluid.
- QC material should be stable for prolonged periods without any interfering preservatives.
- QC material should be free of communicable diseases like bacteria, viruses, and fungi.
- QC material should have a known concentration of the analytes.
- QC material should be easy to store and dispense.
- QC material needs to be affordable and not too costly.
Quality control objectives are:
- QC provides continuous accuracy of the results.
- QC gives an early warning about the accuracy of the test so that early remedies may be taken to avoid great mistakes.
- QC compares the tests at a different time from the same control sera.
Many tools are used for quality control like:
- Procedure manuals.
- Maintenance schedules.
- Calibrations.
- Quality assurance program.
- Training.
Quality control will be different for the different disciplines of pathology:
- Quality assurance for the blood transfusion.
- Quality assurance for microbiology.
- Quality assurance for biochemistry.
- Quality assurance for surgical pathology.
- Quality control for hematology.
Quality control depends upon:
- The time between the collection and the performance of the test e.g.
- Leukocytes and RBCs utilize glucose and cause a steady decrease in glucose concentration.
- Specimen storage also causes an error in the result.
- Evaporation of the sample may cause the wrong result like electrolytes.
- Exposure to light affects the Bilirubin level.
- Refrigeration will affect lactate dehydrogenase (LDH).
- The clerical mistake may occur at any stage.
Quality control
Quality control purposes are:
- To maintain a continuous record of the precision of the tests.
- It gives an early warning of the control trends, and early action will be taken before a great mistake occurs.
- It provides valid judgment on the accuracy of results by comparison with the known sera.
- This is very important for automated analyzers to check their performance.
- Monitor the analytic process and help to find which method is more accurate.
- This also helps to evaluate the technologist’s skills.
- Determine analytical errors during analysis.
- Prevent incorrect patient values.
- The monitoring of the analytic values is compared with known standards and compared with their expected values.
Quality control of various terms used are:
- Accuracy means the true value of the analyte. This isn’t easy to define the true value of a substance.
- The value, in comparison to the known control, has some advantages.
- Precision is the measure of reproducibility for that particular test. A method may give excellent precision but poor accuracy.
- Mean is a basic statistical work, where this is the mean of the sum of data divided by the number of items.
- The mode is the value that occurs most frequently in a list of data items. It is not affected by extreme values.
- Standard deviation is a mathematical concept. This is very important because they are not acceptable if the mean values are outside of a standard deviation of >2.
- Median when the data is arranged in ascending or descending manner, the number that occupies the central position is median.
- Centile is the percentile; the value is greater than a specified percentage of the list of values.
Analytic factors can be minimized, which depends upon instrumentation and reagents.
- A schedule of daily and monthly preventive maintenance is needed for each instrument.
- Keep a check on water quality, power supply, calibration of electrical balance, and calibration of glassware and pipettes.
- Reagents and kits should be dated when received and when opened.
- Run new lots of the reagents with the old lot in parallel before being used for analysis.
- The primary standard is the most highly purified substance.
- The secondary standard is one whose concentration is determined by analysis and compared with the primary standard.
- Post-analytic errors are due to the recording and reporting of the results.
Analytic errors are separated into:
- Random errors affect precision and are the basis for varying differences between repeated measurements.
- The systematic error component indicates a constant difference, either increased or decreased. This may be caused by:
- Poorly made reagents or standards.
- Instrumentations defects
- Poorly written procedures.
Quality control material should be:
- Available in sufficient quantity.
- It should be stable during a period of a minimum of one year.
- Keep in small volumes.
- Its concentration should vary minimally.
- Their composition should not vary from vial to vial.
- Control material should be tested like the test sample.
External quality assessment:
- This is the program in which the specimens are subjected to other laboratories for analysis, and the individual laboratory results are compared.
Total quality management focuses on:
- Customer. The users are doctors and nurses, while customers are patients.
- Management commitment.
- Training of the workers.
- Measurement through quality improved tools.
- Quality improvement occurs when the problems are permanently eliminated. Issues arise from imperfect procedures, which are 85 %. The remaining 15% of cases need action and performance improvements of individual employees. So the main problems are management problems, and management has the power to change the work process.
Control of the preanalytical mistakes:
- Patients identification and labeling are critical. Barcode technology has reduced these mistakes, which are common in handwritten labels.
- Keep the record of the sample received and then when the report is ready.
- Check the request form, the test tube name, and the requested tests.
- Check the adequate amount of the sample.
- Observe if there is hemolysis or lipemic serum.
- Take the history of food intake, alcohol, drugs, smoking, stress, sleep, and posture because these factors may influence the result.
- Explain all instructions to the patient for the collection of the sample.
- Incorrect containers and incorrect preservatives will affect the result.
- Transport of the sample is very important and maybe critical to some of the tests.
- Processing the sample as separation of the serum, where centrifuge speed, temperature, and the person are important.
Errors in quality control:
Quality control errors in the laboratory are classified into:
- Random errors.
- These mistakes will increase the standard deviation.
- These are present in pipettes and volumetric glassware with manufacturing defects.
- There may be a defect in the instruments and spectrophotometer.
- There may be a defect in the cuvet temperature.
- There may be an effect of light, temperature, and evaporation on the serum or the plasma.
- There may be interference from other substances in the analyzed sample.
- Clerical errors are unavoidable and should not be accepted.
- Labeling the wrong name of the patients.
- Delay in the transport of the sample.
- Incorrect calculations.
- These can be avoided by:
- Well-trained staff.
- By good working organization.
- Well-designed worksheets.
- Thorough checking of the results.
- Systemic errors.
- These errors will displace the mean value in one direction, which may go up and down.
- There may be instability of the reagents.
- There may be an inaccuracy in the standards.
- If the method is nonspecific for the analysis.
- Analysis of analytes by the kinetic method at 340 nm is critical.
- Some errors encounter both systemic and random errors.