Strategies for successful quality management within the laboratory

For medical laboratories to provide accurate, consistent, and timely results to physicians and patients, lab directors and supervisors need to implement quality management systems. By doing so, management teams can reduce reagent and equipment costs, ease the burden on personnel, handle large amounts of documented data and results, and meet patient and client expectations.

A thorough understanding of International Organization for Standardization (ISO) standards, tools available to lab quality managers, and the 12 quality systems essentials established by the Clinical and Laboratory Standards Institute (CLSI) is crucial for successful quality management in the laboratory. Incorporating standardized building blocks and facility infrastructure at the highest standards can help laboratories with process improvement that will ensure they produce reliable diagnostic results for patients while avoiding costly errors.

Quality control is crucial in labs and ensures that all patient results and data are precise and accurate. A study by Ibrahim and colleagues found that unsatisfactory laboratory results stemmed from “clerical, methodological, technical problems with proficiency testing materials, and random errors.”¹

Therefore, lab leaders must find ways to implement quality control within the lab. Some ways that lab managers can implement quality control and management is through continuous improvement processes, control sample testing, monthly peer testing, and review with proficiency testing through accredited institutions like the ​​College of American Pathologists (CAP).² Other ways to ensure quality control are improving lab resources, immediately troubleshooting reagent and equipment problems, proactively training staff members, team building, and maintaining good communication with internal team members and external collaborations.^3,4

One of the best ways to improve quality management in laboratory settings is by implementing a laboratory quality management system (LQMS).

The ISO and the CLSI define a quality management system as “coordinated activities to direct and control an organization about quality.” For laboratory accreditation, a quality management system is typically required.

An LQMS supports three phases of a full laboratory environment:⁵

• Pre-analytic phase - sample preparation and transportation
• Analytic phase - activities during operational testing and research
• Post-analytic phase - reporting

Especially during times with an abnormally high influx of test samples, like during the COVID-19 pandemic, having a quality management system that can help improve lab workflow is critical for long-term success in public health. In addition, a quality management system can help mitigate risks and identify gaps. 

Overall, implementing a quality management system can:⁶

• Reduce errors
• Increase customer satisfaction
• Improve operations
• Increase accreditation assessment

ISO 9001

International Organization for Standardization (ISO) 9001 is a standard that focuses on quality management systems that are applicable to laboratories.⁷ It outlines requirements when an organization: 

• “needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements”⁷
• “aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity”⁷

These policies and procedures are generalized to any organization but can be used in the medical laboratory setting to further laboratory performance and improve workflow quality. Data from a retrospective study in over 160 Austrian laboratories showed that implementing and maintaining quality systems such as ISO 9001 can positively impact and improve laboratory testing performance and healthcare organizations by significantly reducing errors.⁸

ISO 15189

ISO 15189 is a document that describes the requirements for quality and competence in medical laboratories standards, specifically the structure of laboratory operations, and includes both management and technical requirements.^9,10 Management requirements focus on a quality management system for lab activities that can meet customer needs and areas for improvement, including organization and management responsibility, examination by referral laboratories, control of records, and evaluation and audits. 

Conversely, technical requirements for quality management in the laboratory focus on technical competency and standard operating procedures, including accommodation and environmental conditions, the quality of examination results, post-examination processes, and laboratory information management.

While ISO 15189 accreditation for laboratories can be a long process, implementing these standards can help reduce costs and catch errors before they occur while engaging personnel to ensure the highest results to help improve patient care.  

ISO 17025

ISO 17025 is a national and internationally recognized standard focusing on testing and calibration laboratories for demonstrating operational competency and the ability to generate quality test results.¹¹

ISO 17025 can provide multiple benefits to laboratories, including:¹²

• Increasing credibility
• Assuring compliance
• Validated performance
• Boost in clientele
• Reduced costs with improved timeliness
• Better efficiency

The role of a quality manager is to ensure that labs and personnel adhere to strict standards. These team leaders are responsible for guiding a lab’s activities such that every part of the lab, from reagents to equipment to personnel, is running as smoothly and efficiently as possible. There are several tools that can help leaders better implement quality assurance in their laboratories.
 

The Laboratory Quality Stepwise Implementation (LQSI) tool from The World Health Organization (WHO) 

Implementing laboratory management has been important for agencies like the WHO to help build LQMS for anticipating potential outbreaks and emergencies. Through training materials and other guidance documents, WHO has been able to strengthen laboratory standards and systems across the world.¹³ In 2014, WHO also launched the LQSI tool, a free website to help laboratories implement quality management systems.¹⁴ The goal is to help medical laboratories implement a quality management system and achieve accreditation that complies with ISO 15189.  

LQSI is available to all diagnostic labs for clinical or public health purposes and is separated by phases that can be implemented in a stepwise fashion. The four phases include:

• Ensuring operations are conducted correctly and safely

• Controlling and assuring quality and traceability

• Proper management, leadership, and organization

• Continued improvement for accreditation 

In 2018, Datema and colleagues evaluated LQSI to determine how the tool can effectively implement a quality management system.¹⁵ At the time, the tool was accessed by 130,986 unique users, with the top users located in India, the USA, Russia, and the Philippines. The results showed that the tool improved services provided by these laboratories and was associated with better clinical care and disease surveillance capacity.

Outside of the LQSI tool from WHO, there are several third-party LQMS software-based tools that lab managers can consider. While regulatory agencies do not require these software tools, they can be instrumental in adopting new automated processes to replace manual procedures. In some cases, these tools are cloud-based, which means that data limitations will not constrain labs and it also offers the ability to share results easily and securely with other labs.^16,17

Laboratory information management system (LIMS) 

Lab managers can also use LIMS, a software-based tool that manages samples and data. These tools can help improve the quality and timeliness of results that help support sample management and data tracking in addition to integrating reagents, instruments, and applications. For example, a recent study showed that taking an LIMS approach to managing non-clinical COVID-19 data demonstrated that this system can be utilized for future pandemics to accelerate medical developments through systematic data management.¹⁸

Multiple tools like LQSI and LIMS can be critical in advancing quality control within the laboratory. Lab managers must consider how these software-based approaches can decrease diagnostics errors and improve process control so patients can get accurate and reliable results.

Creating a quality management system is crucial in improving the reliability, accuracy, and timeliness of results in laboratory environments. The CLSI has created a set of 12 quality systems essentials that are the basis to ensure a laboratory's quality management system infrastructure is successful. The quality system essentials (QSE) are:^6,19

• Organization and leadership - activities of key leadership responsibilities to meet regulatory requirements
• Customer focus - meeting expectations of clients and customers
• Facilities and safety management - maintenance of programs and facilities
• Personnel management - recruiting and maintaining laboratory staff
• Supplier and inventory management - partnerships with suppliers and vendors
• Equipment management - upkeep and maintenance of equipment
• Process management - workflow requirements
• Documents and records management - managing procedural documents for workflow
• Information management - recordkeeping
• Nonconforming event management - identifying nonconformances and correcting problems
• Assessments - monitoring lab processes for functionality
• Continual Improvement - finding opportunities for improvement

Quality management in the laboratory and having a strategy for LQMS is vital to meet the expectations of customers, like patients and physicians, and to ensure that clients receive the highest quality results in a timely fashion. Lab directors can improve efficiency and productivity throughout the organization with a manageable workflow. Labs must adhere to compliance requirements and stay on course with the highest laboratory quality.