Karamara General Hospital Laboratory Assessment

In a significant stride towards enhancing healthcare quality, the Karamara General Hospital Laboratory recently underwent a comprehensive assessment using the SLIPTA (Stepwise Laboratory Improvement Process Towards Accreditation) Framework. The audit, conducted by Zekarias Dagne and Mahdi Ismael, revealed remarkable progress, positioning the laboratory as a leader in regional diagnostic services.

A Strong Achievement: Two Stars and Rising

The Karamara General Hospital Laboratory achieved an impressive overall score of 246 out of 367 possible points, which translates to 67.5% compliance. This outstanding performance places the laboratory at a 2 Stars rating according to the SLIPTA star rating criteria (Version 03), which recognizes compliance between 65-74% (241-277 pts). This is a strong foundational achievement, indicating excellent progress in their quality journey and a clear commitment to international standards.

Pillars of Excellence: Extensive Strengths Noted

The assessment highlighted an extensive list of areas where Karamara General Hospital Laboratory demonstrates exemplary adherence to quality management systems. Their commitment is evident across numerous critical domains:

Robust Management System & Documentation: The laboratory boasts a 100% compliance in its legal entity documentation, a current and well-communicated quality manual, comprehensive document and records control (especially for internal documents), and easily accessible quality documents. Policies and objectives are established, acknowledged, and implemented at all levels, with proper management of discontinued quality documents.
Exemplary Leadership & Personnel Management: The laboratory shines with 100% compliance in its organizational code of conduct, effective deputization processes, and a fully implemented personnel management procedure. A clear duty roster and an up-to-date organizational chart are in place. The laboratory is directed by qualified and competent personnel who are fully authorized for specific activities, including method selection and result release. Procedures for personnel training, competency assessment, and performance review are all rigorously defined and implemented, supported by regular personnel meetings and comprehensive personnel records.
Outstanding Customer Focus: Karamara's commitment to patient and user satisfaction is evident with 100% compliance in advisory services provided by qualified staff, robust procedures for handling complaints and feedback (with records of resolution), and established processes for treating patients' well-being and samples with due care and respect. Their service agreements (including POCT) are well-defined and implemented, and laboratory information for patients and users is readily available and understood. A strong communication policy on delays and effective utilization of customer feedback further underscore their patient-first approach.
Comprehensive Equipment Management: The laboratory demonstrates 100% compliance in all aspects of equipment management, including access to required equipment, adherence to proper protocol (installation, labeling), training, competency, and authorization of users. Their procedures for validation, verification, and calibration are fully implemented and documented, ensuring metrological traceability. Routine user and external service maintenance are consistently performed and recorded, and manufacturer's operator manuals are readily available. Precautions are in place to prevent unintended adjustments, and defective/obsolete equipment is properly managed.
Proactive Quality, Risk & Supply Chain Management: The laboratory excels in internal audits (100% compliant), risk management (100% compliant in identification, action plans, and evaluation), and the use of quality indicators across pre-examination, examination, and post-examination processes, with outcomes consistently used for improvement. Their externally provided products and services and purchasing and inventory control procedures are 100% compliant, with thorough inventory control records, management review of supply requests, and efficient inventory systems (including FEFO practice and proper disposal of expired products).
Rigorous Process Control & Information Management: Karamara shows 100% compliance in continuity and emergency preparedness planning (with implemented and tested plans), pre-examination processes (including test request and sample receipt/handling), and documentation of examination procedures. Reagents and consumables acceptance testing is thorough, and Internal Quality Control (IQC) is performed, monitored, and reviewed with corrective actions. Comparability of examination results and monitoring/reviewing environmental conditions are also 100% compliant. Their participation in External Quality Assessment (EQA) is comprehensive, and procedures for verification/validation of examination methods and measurement uncertainty (MU) are fully established and documented. Biological reference intervals are well-defined. The reporting and release of results are robust, with legible, verified reports identifying authorizing personnel and containing all required elements, traceable to equipment. Their Laboratory Information System (LIS) procedure is well-defined, with securely archived data, clear authorities/responsibilities, and consistent verification after upgrades and maintenance records.
Effective Nonconforming Event Management & Continual Improvement: The laboratory demonstrates 100% compliance in its procedures for handling nonconforming work and nonconformities, including thorough documentation, root cause analysis, and corrective actions. Resumption of testing is properly authorized. Their commitment to continual improvement is also 100% compliant, with identified activities and communicated outcomes.
Comprehensive Facilities & Safety: Karamara's dedication to a safe and functional environment is reflected in 100% compliance across all safety aspects. This includes a defined laboratory safety procedure, adequacy of size and layout, distinct patient care areas, excellent housekeeping, appropriate physical work environment (ventilation, climate, wiring, backup power, water, signage), secured laboratory access, adequate storage areas, well-maintained facilities, properly used and certified safety cabinets, a comprehensive safety program, proper waste disposal, safe hazardous chemical handling, robust fire safety measures, regular safety audits, readily available safety equipment and PPE, implemented personnel vaccinations and post-exposure prophylaxis, thorough management of adverse incidents/injuries, comprehensive safety training for all personnel, a designated safety officer, and implemented biosecurity policies.

Areas for Further Refinement: Building on Success

While the laboratory has achieved significant milestones, the assessment also identified a few areas of partial compliance that, with focused attention, can further elevate their quality management system:

Document Control Record (50%): At the time of audit, no documented revision history was stated for all quality documents. This is crucial for tracking changes and ensuring personnel are using the most current versions.
Data Files (50%): Archived documents are not labelled, indexed, and retention time was not specified, which can hinder easy and timely retrieval of records.
Archived Patient Results Accessibility (50%): The laboratory has no access to get laboratory-specific archived results from the LIS system, and only Genexpert patient results are archived, not easily retrievable. This impacts patient care and data management.
Budgetary Projections (50%): Approved budget projection is available but did not incorporate resources for IQC, training, calibration, and other quality costs. This indicates a gap in comprehensive financial planning for quality assurance.
Routine Review of Quality and Technical Records (33.33%): All technical and quality records are not monitored at the time of assessment. This is a significant finding as it means the laboratory cannot consistently identify and address recurrent problems or evaluate new activities.
Management Review Inputs (33.33%): While a management review was conducted, some inputs like Fulfillment of objectives, performance of external providers, and risk management were not well reviewed. This limits the effectiveness of the management review process.
Service Supplier Performance Review (50%): Performance monitoring of external suppliers (including referral laboratories, technical consultants, and EQA providers) is not consistently conducted. This means the laboratory may not be adequately ensuring the quality of externally provided services.
Purchasing Specifications (50%): The laboratory does not consistently provide specifications for their services, supplies, and consumables when placing requisitions. This can lead to procurement of incorrect or suboptimal items.

Moving Forward: A Commitment to Continuous Improvement

The "2 Stars" rating is a testament to Karamara General Hospital Laboratory's strong commitment to quality. By systematically addressing the identified areas of partial compliance, particularly those related to comprehensive documentation control, data accessibility, and the thoroughness of review processes, the laboratory is well-positioned to further strengthen its quality management system. This ongoing dedication will ensure even higher standards of diagnostic services, contributing significantly to improved health outcomes for the community it serves.