Quality Management in Laboratories

Quality is defined as conformance to requirements, not merely "goodness" or "elegance".
Quality Indicators are established measures used to assess an organization's performance and meeting expectations.
Eight Steps to Developing Successful Indicators: objective, methodology, limits, interpretation, limitations, presentation, action plan, exit plan.
Essentials for Implementation: Commitment, Planning, Structure, Leadership, Participation and Engagement, leading to Continual Improvement.

Laboratory Performance

Laboratory tests are influenced by: laboratory environment, knowledgeable staff, competent staff, reagents and equipment, quality control, communications, process management, occurrence management, and record keeping.
Laboratory errors cost in time, personnel effort, and patient outcomes.

Twelve Quality System Essentials

Organization: This includes human resources, job qualifications, job descriptions, orientation, training, competency assessment, professional development, and continuing education.
Personnel: The focus here is on the human capital of the lab, including their qualifications, training, and development.
Equipment: This encompasses acquisition, installation, validation, maintenance, calibration, troubleshooting, service and repair, and records.
Purchasing and Inventory: Includes vendor qualifications, supplies and reagents, critical services, contract review, and inventory management.
Process Control: Emphasizes quality control, sample management, method validation, and method verification.
Information Management: Focuses on confidentiality, requisitions, logs and records, reports, and computerized laboratory information systems.
Documents: This includes creation, revisions and review, control, and distribution.
Records: Involves collection, review, storage, and retention.
Occurrence Management addresses complaints, mistakes, problems, documentation, root cause analysis, immediate actions, corrective actions, and preventive actions.
Laboratory Assessment includes:
- External: Proficiency testing (EQA), inspections, and accreditations.
- Process Improvement: opportunities for improvement (OFIs), stakeholder feedback, problem resolution, risk assessment, preventive actions, and corrective actions.
Customer Service: Involves customer group identification, customer needs, and customer feedback.
Facilities and Safety: Focuses on a safe working environment, transport management, security, containment, waste management, laboratory safety, and ergonomics.

Information Management

Unique identifiers for patients and samples should be consistently used.
Standardized test request forms should be used for clarity and accuracy.
Logs and worksheets should be maintained to track sample flow, test results, and observations.
Procedures are needed to ensure data recording and transmission accuracy.
Protection against data loss is critical through backups and data recovery mechanisms.
Patient confidentiality and privacy must be strictly adhered to.
Effective reporting systems are necessary to generate comprehensive reports for analysis, decision-making, and communication of results.
Effective and timely communication amongst laboratory personnel and patients is critical.

Occurrence Management

Occurrence management (incident management) is essential for quality laboratory testing and results.
Simpler QMS automates recording and tracking of nonconformances, ensuring efficient handling of issues.
The system automates notifications and reminders for prompt action on identified issues.
Simpler QMS seamlessly links nonconformances to Corrective and Preventive Action (CAPA) processes.
The software allows for comprehensive monitoring of nonconformances by product, process, customer, equipment, or supplier.

Assessment

Internal Audits are conducted by laboratory personnel to identify and address weaknesses.
External Audits are conducted by external professionals for accreditation, certification, and licensing.
SimplerQMS offers a comprehensive CAPA management software solution to streamline corrective and preventive actions.

Customer Service

Customer satisfaction is paramount in the medical laboratory industry.
Laboratories should understand their clients, including patients, physicians, public health agencies, and the community.
The laboratory quality manager is responsible for measuring customer satisfaction, addressing issues, and implementing feedback systems.
Simpler QMS provides a complaint management solution to track, analyze, and resolve complaints.

Facilities and Safety

The laboratory workspace should be designed to accommodate workload, ensure quality, and prioritize personnel safety.
Neglecting laboratory safety leads to costs, reputational damage, customer loss, low staff retention, and increased human resource costs.
The laboratory manager is responsible for safety and quality, including lab design, risk assessment, and ensuring a safe environment.
Risk assessment is essential for managing and minimizing risks to employees.
Simpler QMS assists in identifying and assessing potential risks, developing risk mitigation plans, and implementing control measures.

Role of Laboratory Quality Management Software

Laboratory quality management software is designed to streamline and improve quality processes.
This software offers a comprehensive solution for managing laboratory operations, ensuring regulatory compliance and industry best practices.
It supports the 12 essential elements of the quality management system in medical laboratories.
SimplerQMS is specifically designed for life sciences, and provides robust support for compliance with various requirements.

SimplerQMS

SimplerQMS offers functionalities aligning with the 12 essential elements of a laboratory quality management system including: document management, employee training, nonconformance management, CAPA management, audit management, risk management, and more.
SimplerQMS is a fully validated solution, validated according to ISPE GAMP5 guidelines.