Advisory and Interpretative Services under ISO 15189:2022: A Prospective Study of Patient-Initiated Laboratory...

ISO 15189:2022 requires accredited medical laboratories to establish advisory and interpretative services to support appropriate test selection, result interpretation, and effective utilization of laboratory examinations.Direct-to-consumer and patient-initiated laboratory testing is reshaping traditional healthcare communication. Patients increasingly seek direct consultation with laboratory physicians for test selection and result interpretation. This study describes the drivers, patterns and perceived value of such interactions in routine laboratory practice.

A prospective observational study was conducted over 12 months at a high-volume ISO 15189:2022 accredited referral laboratory. All unsolicited, patient-initiated advisory consultations with laboratory physicians were systematically documented using a structured logbook. Consultations were categorized by type (pre-examination advice, post-examination interpretation, clarification of abnormal findings, and resolution of inter-laboratory discrepancies). All abnormal or discordant results discussed during consultation had undergone analytical verification in accordance with internal quality control and validation procedures. Patient satisfaction was assessed using a 5-point Likert scale. Descriptive statistics were applied.

A total of 1,800 advisory consultations were recorded during the study period. The most common categories were postexamination interpretative consultation (35.6%) and clarification of abnormal results (28.3%), followed by pre-examination advice (20.0%) and resolution of inter-laboratory discrepancies (12.2%). Frequently discussed analytes included glucose profiles, lipid parameters, infectious disease serology, and screening tests. Satisfaction data were available for 1,625 consultations, with a mean score of 4.5 ± 0.6; 90% of respondents rated the consultation as satisfactory or very satisfactory.

These findings highlight the growing demand for professional laboratory interpretation in patient-initiated testing environments and support the inclusion of advisory consultations as a measurable quality indicator within laboratory management systems.