Perform Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Assessment using eAuditor

Performing Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) Assessment using eAuditor ensures a thorough evaluation of laboratory quality management systems, technical competence, documentation practices, biosafety, and compliance with ISO 15189 requirements while maintaining accuracy, reliability, and regulatory readiness.

1. Purpose of SLIPTA Assessment

The Stepwise Laboratory Quality Improvement Process Towards Accreditation assessment is designed to measure a laboratory’s progress toward international accreditation by evaluating compliance with quality and technical standards.

It enables laboratories to:

• Measure alignment with ISO 15189 and national regulatory requirements
• Identify gaps in quality management systems (QMS)
• Improve patient safety and test result reliability
• Strengthen documentation, process control, and risk management
• Prepare for formal accreditation audits
• Track improvement using a star-based rating system (0–5 stars)

Using eAuditor ensures assessments are standardized, evidence-based, and fully traceable.

2. Setting Up Stepwise Laboratory Quality Improvement Process Towards Accreditation Assessment Template in eAuditor

2.1 Assessment Details

Record the following in eAuditor:

• Laboratory name and department/section
• Location and facility type
• Date and time of assessment
• Assessor(s) name and designation
• Assessment type (baseline, surveillance, or pre-accreditation)
• Applicable standards (SLIPTA checklist version, ISO 15189 edition)

3. Management & Organization

3.1 Leadership and Structure

Evaluate whether:

• Organizational chart is available and current
• Clearly definr roles and responsibilities
• Laboratory management demonstrates commitment to quality
• Document and communicate quality objectives

3.2 Quality Policy

Verify that:

• A formal quality policy exists
• Staff are aware of the quality policy
• Review policy periodically

4. Document & Record Control

4.1 Documentation System

Check that:

• SOPs are approved, controlled, and accessible
• Remove obsolete documents from use
• Maintain version control

4.2 Records Management

Confirm that:

• Test records, QC logs, maintenance logs, and training records are maintained
• Records are protected from damage or unauthorized access
• Define retention schedule

5. Personnel Management

5.1 Staff Competency

Assess whether:

• Job descriptions exist for all staff
• Qualifications are verified
• Conduct competency assessments regularly

5.2 Training & Continuing Education

Verify:

• Document training plans
• New staff receive induction training
• Track ongoing professional development

6. Equipment Management

6.1 Equipment Inventory

Confirm that:

• Maintain equipment list
• Assign unique identification numbers
• Status labels (in service/out of service) are displayed

6.2 Maintenance & Calibration

Check whether:

• Preventive maintenance schedules exist
• Calibration records are available
• Equipment failures are documented and investigated

7. Process Control & Quality Assurance

7.1 Pre-Analytical Phase

Evaluate:

• Sample collection procedures
• Labeling and transportation controls
• Rejection criteria

7.2 Analytical Phase

Verify:

• Use validated test methods
• Internal quality control (IQC) is performed
• Staff follow SOPs strictly

7.3 Post-Analytical Phase

Confirm that:

• Result verification procedures exist
• Reports are accurate and timely
• Communicate critical results properly

8. Purchasing & Inventory Management

8.1 Supplier Evaluation

Check whether:

• Approved supplier list exists
• Review supplier performance
• Document contracts or agreements

8.2 Stock Control

Verify:

• Reagents are labeled and stored correctly
• Expiry dates are monitored
• Stock levels are tracked to avoid shortages

9. Information Management

9.1 Data Integrity

Assess whether:

• Laboratory information systems (LIS) are secure
• Data entry and result transmission are controlled
• Backup procedures are implemented

9.2 Confidentiality

Verify:

• Patient information is protected
• Access to records is restricted

10. Occurrence Management & Risk Control

10.1 Incident Reporting

Confirm that:

• Personnel report non-conformances and errors.
• Conduct root cause analysis.
• Personnel document corrective actions.

10.2 Risk Assessment

Check whether:

• Personnel identify risks to staff, patients, and processes.

• Personnel implement mitigation measures.

11. Internal Audits & Management Review

11.1 Internal Audits

Evaluate:

• Personnel maintain the audit schedule.
• Audits cover all QMS elements
• Personnel document the findings.

11.2 Management Review

Verify that:

• Personnel conduct reviews at planned intervals.
• Designated members record the action items and follow them up.

12. Biosafety & Facility Safety

12.1 Biosafety Practices

Check:

• Use of PPE
• Waste segregation and disposal
• Spill management procedures

12.2 Facility Conditions

Assess:

• Cleanliness and workflow design
• Emergency exits and signage
• Availability of safety equipment (fire extinguishers, eyewash stations)

13. Scoring, Non-Conformances & Corrective Actions in eAuditor

13.1 SLIPTA Scoring

Use eAuditor to:

• Assign scores per section
• Automatically calculate total score
• Determine star rating

13.2 Corrective Actions

Record in eAuditor:

• Non-conformances
• Root causes
• Assigned responsibilities
• Target completion dates
• Evidence of closure

14. Reporting & Continuous Improvement

14.1 Digital Reporting

Generate:

• SLIPTA scorecard reports
• Gap analysis summaries
• Management dashboards

14.2 Improvement Planning

Use results to:

• Develop quality improvement plans
• Prioritize high-risk gaps
• Monitor progress over time

Summary

The SLIPTA Assessment using eAuditor provides laboratories with a structured and evidence-driven method to evaluate quality management systems against ISO 15189 requirements. By digitizing checklist scoring, documentation review, equipment control, staff competency evaluation, biosafety checks, and corrective action tracking, laboratories gain clear visibility into compliance gaps and improvement priorities. This approach strengthens result accuracy, patient safety, regulatory confidence, and long-term accreditation readiness while enabling continuous monitoring of quality maturity through measurable star ratings.