Translating global standards to local practice: Comparing International Organization for Standardization 15189:2012 and 2022 with implementation insights from the National Accreditation Board for Testing and Calibration Laboratories 112 in India

Impartiality

Moving beyond a generic declaration, laboratories must continuously identify, document, and mitigate potential risks to impartiality, such as conflicts of interest or undue influence.

Confidentiality

Robust safeguards are mandated, including signed confidentiality agreements for all staff at recruitment, regular training, and formal agreements with patients to protect their information.

Patient rights and transparency

A key update is the extension of patient rights. Laboratories are now required to proactively inform patients of any incidents that caused or had the potential to cause harm (e.g., sample mislabeling or delays in reporting results). This commitment to transparency must be supported by mandatory documentation of the incident and the steps taken to mitigate its impact, ensuring accountability.

Implementation challenges and solutions

A common challenge observed during assessments is that laboratories often limit impartiality to a policy statement without demonstrating how risks such as conflicts of interest or undue influence are identified, monitored, and mitigated. Staff are not always sensitized to these risks, leading to gaps in practical implementation. To address this, laboratories should establish a structured process for ongoing risk assessment, train staff to recognize and report potential threats to impartiality, and implement monitoring systems with documented corrective and preventive actions.^[7]

Leadership and accountability

The laboratory director’s responsibilities are expanded to include risk management, with qualifications aligning with the laboratory’s disciplines. While overall responsibility remains with the director, duties can be delegated with clear documentation. Notably, NABL 112 allows for part-time directors (minimum 4 h/day) in small or micro laboratories. Furthermore, while ISO 15189 does not mandate a dedicated quality manager, NABL 112 specifies that the individuals responsible for the quality management system must be full-time employees, a significant adaptation for the Indian context.

Expanding operational scope and defining performance

The standard formally expands the scope of activities to include POCT, mobile laboratories, and off-site sample handling, requiring these services to meet the same rigorous standards as the main facility. To monitor performance within this expanded scope, laboratories must define measurable quality indicators across the entire testing cycle, enabling data-driven evaluation and continual improvement in service delivery. In addition, laboratories must actively engage with users regarding test selection and result interpretation and maintain documentation to demonstrate that advisory support has been provided.

Systematic risk management

A major addition in the 2022 standard is the requirement for a more structured and systematic approach to risk management. Laboratories must proactively identify, assess, and mitigate risks at every stage of testing, from specimen collection and transport to equipment performance, staff competency, and even supply chain reliability [Figure 2].^[8]

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Figure 2:

Laboratory risk management cycle.

Export to PPT

This process must be thoroughly documented, with mitigation measures recorded and reviewed annually or when processes change, ensuring proactive safeguarding of patient safety and result validity.

Implementation challenges and solutions

Laboratory directors, though permitted to delegate responsibilities, are often not visibly engaged in daily governance, weakening accountability. To address this, directors should actively participate in key activities such as quality indicator reviews, management meetings, and oversight of risk management.^[9] Another issue is incomplete risk management; many laboratories conduct risk assessments, but they often stop at identification without clearly documenting corrective actions or evaluating their effectiveness. To bridge this gap, laboratories should adopt a structured risk management cycle that not only identifies risks but also tracks mitigation measures, assigns responsibilities, and documents follow-up reviews to confirm effectiveness.^[9,10]

Human resources

Laboratories must ensure staff are qualified, trained, and competency-assessed, with roles defined through authorization matrices. Staffing levels must align with test complexity and volume, with requirements scaled for laboratory size: large facilities require full-time consultants per discipline, medium laboratories need core discipline consultants, and small/micro laboratories may employ part-time consultants (minimum 4 h/day) with proper documentation of attendance and activities.^[4]

Facility and safety

A greater emphasis is placed on a preventive, safety-oriented approach while retaining core requirements such as adequate space, separation of incompatible activities, and prevention of cross-contamination. Greater emphasis is now placed on staff safety, ergonomic design, and risk mitigation. Laboratories must implement measures such as noise monitoring, chemical ventilation, and ergonomic workspaces to reduce long-term health risks. Electrical safety is strengthened with biannual verification of power points and prohibition of unsafe extension cords. Clear separation of pre-examination and testing areas is required to prevent interference and ensure process clarity.^[4]

Equipment management

A rigorous, lifecycle-based approach is mandated for all equipment. Key requirements now include mandatory installation/operational/performance qualification for new or relocated devices and re-verification after significant changes. The scope of calibration is expanded to include POCT and non-analytical instruments (centrifuges, pipettes, incubators, and thermometers) with stringent requirements for traceability and data retention.^[4] Table 3 summarized the core requirements for equipment, calibration, and environmental safety.^[4]

Reagents and consumables

A structured, performance-based approach is required. This includes lot-specific acceptance testing (preferably with patient samples), use of Grade II water with documented water quality checks at defined intervals, and robust labeling and tracking systems for in-house reagents. Robust systems for tracking adverse incidents and recalls are mandatory, requiring documented investigations and corrective actions to ensure reagent integrity and patient safety.^[4]

External services and agreements

Laboratory accountability is extended to all outsourced services. Formal agreements are required with users and POCT operators, ensuring transparency about accredited tests. This includes providing users with a clear list of accredited and non-accredited parameters, along with their methods and turnaround times, and making a directory of services readily available. For referral testing, laboratories must maintain formal documentation, including the accreditation status of referral laboratories and signed memoranda of understanding. A risk-based approach to sample transport and the acceptance of telepathology (with quality safeguards) are now formally recognized.^[4]

Implementation challenges and solutions

Laboratories often fail to monitor vendors and referral laboratories at defined intervals, leading to unverified service quality. This can be addressed by establishing measurable vendor evaluation criteria and conducting regular, documented reviews. Upon receiving reagents and kits, checks for expiry, leakage, and transport temperature are sometimes overlooked; strict physical verification and its documentation upon receipt should be enforced before acceptance. Reagent lot verification is another weak area, where reliance on the manufacturer’s claims replaces laboratory-defined acceptance criteria; instead, laboratories should verify lots against their own past performance data. Competency assessment of staff is also inconsistently performed, with intervals not always defined; this requires a structured, standard operating procedure (SOP) driven approach with documented evaluations (NABL 112 B). Finally, equipment calibration is sometimes outsourced to non-recognized providers, which risks traceability; compliance can be ensured by using calibration laboratories accredited to ISO/IEC 17025, with proper documentation of metrological traceability.

Pre-examination

Now, this stage requires greater accountability from test request to sample receipt. Mandates include the clinical details on all requisitions, with oral requests permitted in emergencies, provided they are documented. Informed consent is required for procedures such as genetic testing or invasive sample collection. The handling of compromised samples (e.g., mislabeled, hemolyzed) must involve a documented risk assessment and clinical justification, with any associated risks communicated in the final report. Sample transport requires strict safeguards, including temperature control, triple packaging, and time-logging to ensure integrity and traceability.^[10] Laboratories retain responsibility for externally collected samples, formalized through agreements, competence checks, and audits. The scope now formally recognizes telepathology (with safeguards for traceability and image quality) and POCT, requiring clearly defined responsibilities between the central laboratory and clinical units.

Examination and quality assurance

Rigorous verification is required for new tests and after significant changes, including equipment repair or method updates. Validation is necessary when methods are modified, such as unlisted matrices, altered sample handling, reagent changes, or shifts between qualitative and quantitative use. Records must demonstrate performance specifications and fitness-for-purpose. ISO 15189:2022 allows quality control (QC) frequency to be risk-based, whereas NABL 112 requires two levels of internal QC (IQC): daily and once per shift in 24 × 7 laboratories. Control materials must be stable, matrix-compatible, and span the full analytical range. Daily performance is tracked with Levey-Jennings charts and Westgard rules with monthly recalculation of mean, SD, and coefficient of variation (CV%). If commercial controls are unavailable, validated alternatives such as duplicate testing, moving averages, or inter-laboratory exchanges must be used.

Participation in ISO 17043-accredited external quality assessment/proficiency testing programs is mandatory for all applicable tests, including POCT. Failures require documented corrective action and clinical impact review. Where formal programs are absent (e.g., for ammonia, glucose-6-phosphate dehydrogenase, blood gases), alternatives such as replicate testing, inter-laboratory comparisons, or clinical correlation studies must be adopted. Comparability studies across systems and locations are required at least twice yearly using 10-20 patient samples. Statistical tools such as regression analysis or Bland-Altman plots should be applied; clinically significant differences must trigger a review of reference intervals.^[11] NABL further requires histopathology-specific measures, correlating repeat specimens with prior slides, and comparison of frozen sections with final reports. Measurement uncertainty (MU) is mandatory for all quantitative tests, calculated using IQC (MU = CV% × 2). It must be regularly reviewed and applied in method verification, lot-to-lot kit checks, and threshold-based qualitative tests.

Clear, accountable, and traceable reporting

Reports must identify the authorized signatory and undergo documented review before release. Critical results must be clearly marked, and both critical and urgent results require prompt communication, documentation, and escalation protocols. All oral communications must be recorded, and policies for preliminary reporting are required for 24 × 7 laboratories.

Automated release is permitted for non-interpretative tests if systems are validated, outputs are labeled “Auto Verified,” and these systems must include safeguards for errors and downtime. Reports must contain unique patient and sample identifiers, collection and issue dates, laboratory and user identifiers, methodology, reference intervals, decision limits, and decision-support tools. Research tests must be clearly labeled, and all report amendments must be traceable, with revised results issued as separate documents linked to the original.

Robust information management

Information systems are a core laboratory responsibility. All systems, computerized, hybrid, and manual systems must be validated, documented, and secured against unauthorized access. Cybersecurity, downtime planning, and audit trails are mandatory. NABL 112 specifies practical steps: half-yearly laboratory information system (LIS) verification with at least 10 different test types, validation of analyzers- LIS/ hospital information system interfaces, role-based access control, and comprehensive audit trails linking user actions to data.

Implementation challenges and solutions

Laboratories often lack defined policies for oral requests, compromised samples, add-on tests, and the permissible window period for acceptance, leading to inconsistent handling and patient safety risks.^[5] To address this, explicit SOPs and staff training should guide specimen acceptance criteria and documentation. Another challenge is inadequate monitoring at specimen receiving, where checks for transport temperature, vial adequacy, and sample volume are overlooked. These must be systematically verified and documented, with periodic audits of sample transport using statistically adequate sample sizes. In reporting, many laboratories have no contingency plan for suspension of automated release, creating delays and risks to timely communication. A robust fallback plan should be in place, with manual verification of automated release and LIS processes using representative sample sets.^[5]

Proactive risk and opportunity management

Laboratories must now systematically identify and address risks to impartiality and quality, as well as opportunities for improvement. NABL 112 operationalizes this through documented risk registers and mitigation plans.

Structured corrective and improvement actions

A closed-loop process is mandated for handling nonconformities. Findings from incidents, audits, and feedback must lead to documented corrective actions, the effectiveness of which must be verified, ensuring issues are resolved and not just noted.

The effectiveness of the integrated management system is validated through regular evaluation:

Internal audits

Laboratories must conduct audits covering all processes, including sample collection and POCT, at least annually, with documented follow-up on findings.

Management review

Top management is required to periodically review the system’s suitability and effectiveness. These structured reviews must assess audit outcomes, risk assessments, corrective actions, and quality indicators, leading to documented decisions and resource allocation for improvement.

Implementation challenges and solutions

A common challenge is the inconsistent definition and documentation of quality indicators. Laboratories may select indicators without clearly specifying how they are measured, the formulas used, methods of data collection, frequency, or their presentation, which limits their usefulness for monitoring performance. To address this, SOPs should explicitly define each quality indicator, its calculation, collection process, and reporting frequency. Another challenge is the incomplete documentation of management review meetings. Minutes often lack details on discussion points, decisions made, assigned responsibilities, and timelines for action items.