Toward Conscious-State-Aware Quality Management in Clinical Laboratories: Integrating DPV~ICRDAM with FMEA and Sigma Metric

Abstract Background: Ramachandra, Madegowda, Pandey, Prashant, Shivashankar, & Kempegowda (2026) demonstrated that integrating Failure Mode and Effects Analysis (FMEA) with Sigma metrics substantially reduces laboratory errors across pre-analytical, analytical, and post-analytical phases. Yet their study identified persistent challenges: subjective risk-scoring variability, incomplete elimination of high-risk errors (particularly non-intimation of critical values), inadequate attention to the operator’s psychophysiological state, absence of a theoretical framework for the consciousness–performance relationship, and reliance solely on behavioural interventions such as staff training. These gaps point to a broader epistemological lacuna—the laboratory’s human substrate remains untheorised. Methods and Framework: We apply DPV~ICRDAM (Dvi-Pakṣādvaita Vedānta ≡ Inseparable-Complementary-Reflective Dual-Aspect Monism; Vimal, 2026c) to reinterpret each identified challenge. DPV~ICRDAM posits that all entities—including laboratory personnel—exist as Dual-Aspect States (DASs) characterized by inseparable subjective (s) and non-subjective (ns) aspects, governed by the Degree of Effective Māyā (DEM) on a continuum from maximal clarity (DEM < 27%, near-Nirguṇa Brahman) to high cognitive obscuration (DEM ≈ 100%). Results and Proposed Extensions: We propose a DEM-Aware Risk Priority Number (DEM-RPN) that augments standard FMEA scoring with a real-time operator-state parameter, a Dual-Aspect Quality Indicator (DAQI) that monitors both behavioural and psychophysiological markers of laboratory performance, and a Contemplative Intervention Protocol (CIP) grounded in DPV~ICRDAM’s ADS (Active Dynamic Self) framework to systematically lower DEM and thereby reduce subjective scoring variability and error-proneness. Conclusion: DPV~ICRDAM provides a rigorous philosophical–scientific foundation for moving laboratory quality management beyond behavioural compliance toward a consciousness-inclusive model of error prevention. The proposed extensions are testable, compatible with ISO 15189:2022, and open new avenues for interdisciplinary research at the intersection of clinical biochemistry, cognitive neuroscience, and consciousness studies. Keywords: FMEA; Sigma metrics; laboratory quality; DEM; DPV~ICRDAM; dual-aspect monism; Active Dynamic Self; consciousness; risk management; ISO 15189:2022