/**
 * ISO 15189:2022 Medical Laboratory Quality and Competence Compliance Pack
 *
 * ISO 15189:2022 (4th edition) is the international standard for quality and
 * competence in medical laboratories. It replaces ISO 17025-derived approaches
 * for the medical laboratory context and provides specific requirements for
 * quality management systems (QMS) combined with technical competence
 * requirements unique to clinical laboratory practice.
 *
 * Published by ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic
 * test systems). The 2022 edition (4th edition) is aligned with:
 *   - ISO 17025:2017 (General requirements for the competence of testing and
 *     calibration laboratories) — structural parent
 *   - ISO 22870:2022 (Point-of-care testing — Requirements for quality and
 *     competence) — extends ISO 15189 to POCT settings
 *   - ISO 9001:2015 (QMS principles — Annex SL harmonised structure)
 *
 * Recognized by national accreditation bodies:
 *   - CAP (College of American Pathologists) — USA (CAP accreditation aligns
 *     with ISO 15189 and runs alongside CLIA for high-complexity labs)
 *   - ANAB (ANSI National Accreditation Board) — USA (direct ISO 15189 accreditor)
 *   - A2LA (American Association for Laboratory Accreditation) — USA
 *   - COLA (Commission on Office Laboratory Accreditation) — USA
 *   - UKAS (United Kingdom Accreditation Service) — UK
 *   - DAkkS (Deutsche Akkreditierungsstelle) — Germany
 *   - DANAK (Danish Accreditation and Metrology Fund) — Denmark
 *   - COFRAC (Comité français d'accréditation) — France
 *   - NATA (National Association of Testing Authorities) — Australia
 *   - ILAC (International Laboratory Accreditation Cooperation) — MRA framework
 *
 * US regulatory context:
 *   CMS/CLIA (Clinical Laboratory Improvement Amendments, 42 CFR Part 493)
 *   governs clinical laboratory testing in the US. CAP + ISO 15189 accreditation
 *   satisfies CLIA requirements for high-complexity labs under the CMS deemed-
 *   status programme. CAP inspection + ISO 15189 are effectively run together
 *   for high-complexity clinical labs.
 *
 * Standard scope (ISO 15189:2022 main clauses):
 *   §4 General requirements — impartiality (§4.1) + confidentiality (§4.2)
 *   §5 Structural requirements — legal entity + lab director + governance
 *   §6 Resource requirements:
 *     §6.2 Personnel (competence + training + authorisation)
 *     §6.3 Facilities and environmental conditions
 *     §6.4 Equipment (selection, verification, calibration, metrological traceability)
 *     §6.5 Reagents and consumables (receipt + storage + acceptance testing)
 *     §6.6 Service agreements (request + referral + reporting agreements)
 *   §7 Process requirements:
 *     §7.2 Pre-examination (request + patient preparation + sample collection + reception)
 *     §7.3 Examination (validation + verification + IQC + EQA + uncertainty of measurement)
 *     §7.4 Post-examination (review + authorisation + reporting + release + correction)
 *     §7.5 Nonconforming work
 *     §7.6 Data control and information management
 *     §7.7 Complaints
 *     §7.8 Continuity of service
 *   §8 Management system requirements (Option A: full ISO 9001 QMS alignment;
 *       Option B: ISO 15189-internal QMS — either satisfies accreditation)
 *
 * Annexes:
 *   Annex A — Risk management for medical laboratories (ISO 14971 + ISO 22367)
 *   Annex B — Patient safety, ethics, and confidentiality
 *   Annex C — Examiner competence requirements (interpretive + analytical)
 *
 * Key technical competence concepts:
 *   Internal Quality Control (IQC) — continuous monitoring of examination
 *     performance using control materials; Westgard rules or equivalent;
 *     immediate IQC out-of-control action required before patient results
 *     reported (§7.3.7).
 *   External Quality Assessment (EQA) / Proficiency Testing (PT) — mandatory
 *     participation in schemes where available; per §7.3.4; performance
 *     compared against peers and targets.
 *   Validation vs Verification:
 *     Validation (§7.3.2) — confirms an in-house developed or modified
 *       examination procedure fulfils its intended purpose.
 *     Verification (§7.3.3) — confirms a commercially-supplied examination
 *       procedure performs as specified by the manufacturer in the lab's
 *       own environment.
 *   Uncertainty of Measurement (§7.3.6) — labs must evaluate and document
 *     measurement uncertainty for all quantitative examination results.
 *   Metrological traceability (§6.4.9) — calibration traceable to SI units
 *     or certified reference materials through an unbroken chain.
 *
 * Patient-record retention:
 *   20-year baseline (7300 days) — derived from medical record retention
 *   requirements across key jurisdictions: US HIPAA/CLIA (minimum 10 years
 *   post-reporting; CAP recommends 20 years for special tests; CMS CLIA
 *   high-complexity lab records minimum 2 years by regulation; state-law
 *   varies 5–10 years); EU GDPR + national laws (healthcare records 15-30
 *   years post last contact per NHS Wales; 10 years minimum Germany § 630f
 *   BGB; 30 years France clinical records); Australian Health Records Act
 *   (7 years post last service for adults). Conservative 20-year (7300 days)
 *   baseline chosen for cross-jurisdictional medical laboratory compatibility.
 *
 * Incident / event reporting:
 *   72-hour baseline (3 days) — derived from CAP/CLIA event reporting
 *   expectations + ISO 15189 §7.7 complaints/nonconforming work timelines +
 *   GDPR Art. 33 (72h data breach notification for any labs handling EU PHI).
 *   CAP Q-Probes and Q-Tracks programmes track sentinel-event timelines.
 *   CMS/CLIA deficiency reporting under 42 CFR §493.1101 does not impose
 *   a fixed hours-based notification window (investigation-driven), but
 *   immediate clinical action on patient-impacting IQC failures is required.
 *   72h is the common cross-programme baseline for formal notification.
 *
 * @connexum/ai-governance
 */
import { CompliancePack } from './index';
import { CategoryClassifiers } from '../classification/pack-driven-classifier';
/**
 * ISO 15189:2022 Medical Laboratory Quality and Competence Compliance Pack.
 *
 * Pack ID: 'iso-15189'
 * Jurisdiction: International — recognized by CAP (US), UKAS (UK), DAkkS (DE),
 *   COLA, ANAB, A2LA, DANAK, COFRAC, NATA, and all ILAC MRA signatories.
 *   CMS/CLIA-aligned via CAP deemed-status program for high-complexity labs.
 *
 * Guard-layer wiring:
 *   - G1-G4 (audit, logging, classification, session): always active
 *   - G5 (supply-chain): always active — PRC provider blocks; reagent/consumable
 *       vendor qualification; data sovereignty for clinical PHI
 *   - G6 (approval-queue): always active — examination result authorisation;
 *       IQC out-of-control release gate; EQA corrective action approval;
 *       non-conforming work approval before patient results released
 *   - G7 (attestation): always active — lab director attestation for IQC
 *       out-of-control release; clinical pathologist attestation for
 *       interpretive reports; examiner competence attestation (Annex C)
 *   - G8 (anomaly-detector): always active — IQC out-of-control immediate
 *       CRITICAL block (no patient results released until IQC passes);
 *       EQA failure signal detection; examination drift detection
 *   - G9 (transparency): always active — AI-generated interpretive content
 *       must be disclosed + reviewed by clinical pathologist; AI-assisted
 *       IQC rule checking must disclose model provenance
 *
 * Human-in-loop tier:
 *   - T1: Routine QMS records, pre-examination tracking, standard result
 *         reporting (qms-lead review)
 *   - T2: EQA performance failures, examination validation changes, personnel
 *         competence assessments (lab-director + clinical-pathologist sign-off)
 *   - T3: IQC out-of-control (immediate — lab-director + qms-lead + patient-
 *         safety-officer); sentinel events; accreditation non-conformities
 */
export declare const ISO_15189_PACK: CompliancePack & {
    categoryClassifiers: CategoryClassifiers;
};
//# sourceMappingURL=iso-15189.d.ts.map