Laboratory Administration & Management of Pathology Practices

• A quality management system (QMS) can be defined as coordinated activities to direct and control an organization with regard to quality (WHO: Laboratory Quality Management System - Handbook [Accessed 10 July 2023])
• QMS helps coordinate and direct an organization's activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis

Contributed by Hai Duong Nguyen, M.D., M.Sc.

• The QMS model was developed by CLSI and is fully compatible with ISO standards
• Concept of the path of workflow is key to the QMS; it begins with the patient and ends with reporting and result interpretation (see Diagram 3)
• QMS model used here organizes all of the laboratory activities into 12 QSEs
  • Organization
  • Personnel
  • Equipment
  • Purchasing and inventory
  • Process control
  • Information management
  • Documents and records
  • Occurrence management
  • Assessment
  • Process improvement
  • Customer service
  • Facilities and safety
• 12 QSEs represent the most fundamental elements for maintaining quality, safety and efficiency throughout the laboratory's path of workflow (see Diagram 4)
• Diagram 1 provides a comprehensive framework for the development and implementation of an effective QMS in healthcare organizations
  • 12 QSEs provide specific guidance on how to achieve the principles in practice
  • 7 QM principles provide a broad framework for the development and implementation of a QMS
• Table below describes brief instructions for all aspects of a QMS; for detailed and specific instructions, please see the laboratory quality management system handbook by WHO (WHO: Laboratory Quality Management System - Handbook [Accessed 10 July 2023])

12 QSEs	Brief instructions
Documents and records	Creating and implementing new documents Revising existing documents Document control Reviewing, retaining, storing, retrieving and destroying records Modifying records
Organizational structure	Implementing a laboratory quality management system Organizational chart Identifying referral laboratories
Personnel	Maintaining adequate staff resources Job descriptions Documenting personnel qualifications Employee orientation and training Employee competency assessments Continuing education
Equipment	Equipment selection, acquisition, installation, identification and inventory Instrument validation studies Method comparison studies Carryover studies Preventive maintenance Calibration Equipment related service, troubleshooting and corrective actions Retiring instruments
Purchasing and inventory	Use of referral laboratory services Identifying and selecting vendors for supplies and reagents Purchasing supplies and reagents Handling supplies and reagents
Process control	Process identification and validation Specimen management Method validation / verification, reportable ranges and reference intervals Internal quality control
Information management	Patient confidentiality Accessing and using electronic information Reporting results Result modification Reporting delays Communicating result reporting changes Data storage and maintaining data integrity Backup systems
Occurrence management	Identifying and documenting occurrences Remedial actions and investigation of occurrences Analyzing occurrence information and referral for process improvement
Assessment	Internal quality indicator surveillance Internal audits External quality assurance and external proficiency testing External benchmarks Quality assessment report
Process improvement	Identifying opportunities for improvement Problems within processes and opportunities for improvement are identified and documented Root cause analysis and corrective / preventive action plans Quality improvement evaluation
Customer service	Provision of laboratory services Identifying and managing customer needs Managing customer complaints Monitoring customer satisfaction
Facilities and safety	Laboratory design Safety procedures, records and audits Safety training Safety equipment availability and use
Reference: WHO: Laboratory Quality Management System - Handbook [Accessed 10 July 2023]

What is the primary objective of a laboratory quality management system (QMS)?

1. Expand laboratory services
2. Improve patient outcomes
3. Increase laboratory efficiency
4. Reduce laboratory costs
5. Support evidence based decision making

B. Improve patient outcomes. A laboratory QMS is a comprehensive approach to ensuring that a laboratory's services are accurate, reliable and timely and that they meet the needs of patients and healthcare providers. The primary objective of a laboratory QMS is to improve patient outcomes by ensuring that laboratory testing is conducted according to established protocols, that results are accurate and reliable and that they are reported in a timely and efficient manner. Answers A, C, D and E are incorrect because while these may be important secondary objectives of a laboratory QMS, the ultimate goal is to improve patient care and outcomes.

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Reference: Quality management systems

Which of the following quality improvement tools is best suited for identifying the underlying causes of a recurring problem in a laboratory process?

1. Failure mode and effects analysis
2. Flow chart
3. Pareto chart
4. Root cause analysis
5. Statistical process control chart

D. Root cause analysis. Root cause analysis is a quality improvement tool that is widely used in the laboratory to identify the underlying causes of a recurring problem or issue. Root cause analysis involves a systematic process of investigation and problem solving, which helps to identify the fundamental reasons why a problem is occurring, rather than simply addressing the symptoms or immediate causes. Answers A, B, C and E are incorrect because while a statistical process control chart, failure mode and effects analysis, Pareto charts and flow charts are all useful quality improvement tools, root cause analysis is specifically designed to help identify and address the underlying causes of recurring problems in a laboratory process.

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Reference: Quality management systems