A consultancy's scope of service for this
program typically includes:
1.
GAP Analysis & Awareness Training
Initial Assessment: Auditing the existing
lab processes against the seven core chapters of the NABH Medical Laboratory
Standards.
Gap Report: Identifying deficiencies in
personnel, equipment, and process control.
Awareness Sessions: Training all lab
technicians, doctors, and support staff on the recent standards and their role
in the pre-analytical, analytical, and post-analytical phases.
2.
Documentation & System Design
Consultants assist in developing a
comprehensive quality management system, including:
SOP Development: Creating Standard
Operating Procedures for sample collection, handling, testing, and reporting.
Manual Preparation: Drafting mandatory
manuals for Organization and Management, Document Control, and Laboratory
Equipment.
Policy Formulation: Developing policies
for procurement of external supplies and services.
3.
Technical Implementation Support
Process Control: Standardizing protocols
for sample handling and testing to ensure reliable diagnostics.
Equipment Validation: Establishing records
for equipment maintenance and calibration to ensure accuracy.
Quality Control (QC): Implementing
internal and external quality control measures and tracking key performance
indicators (KPIs).
4.
Safety & Regulatory Compliance
Lab Safety Protocols: Implementing safety
measures to prevent contamination and clinical errors.
Statutory Compliance: Ensuring the lab
holds valid documentation, such as a Fire NOC, Pollution Control Board (PCB)
certificate, and valid Bio-Medical Waste (BMW) MOU.
Waste Management: Training staff on the
2026 rules for segregation and disposal of medical waste.
5.
Assessment Readiness & Portal Support
Portal Management: Facilitating the
digital application through the NABH Portal.
Internal Audits: Conducting mock
assessments and training core staff for the self-assessment toolkit (SAT).
NC Resolution: Assisting the lab in
closing any Non-Conformities (NCs) raised during the desktop or onsite
assessment within the required timeframe.
Comparison:
NABH Certification vs. NABL Accreditation
While many consultants offer both, they
serve different functions:
NABH Medical Lab Certification: Focuses on
standardizing core laboratory functions as an entry point for quality
improvement within a broader healthcare context.
NABL Accreditation: Concentrates on
technical competence and accuracy based on international standards like ISO
15189: 2022.
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