Expert guidance on CAP, CLIA, ISO 15189, COLA, TJC, and DNV accreditation — written by laboratory professionals for laboratory professionals worldwide.
Choosing the wrong laboratory compliance software costs laboratories thousands of hours and dollars. This buyer's guide helps lab directors evaluate platforms based on accreditation coverage, ease of use, data security, and total cost of ownership.
ISO 15189 is recognized in over 100 countries as the definitive standard for medical laboratory quality. This guide explains the 2022 revision requirements, how ISO 15189 compares to CAP and CLIA, and the path to accreditation for laboratories worldwide.
Choosing the wrong CLIA certificate category can result in CMS citations, billing denials, and even laboratory closure. This guide explains every CLIA certificate type, which tests fall under each category, and how to upgrade.
CAP accreditation is the gold standard for clinical laboratory quality. This guide walks through every section of the CAP checklist, the most common deficiencies inspectors find, and how modern compliance software eliminates manual tracking.
Temperature excursions are one of the most common CAP inspection deficiencies. This guide covers acceptable temperature ranges for every laboratory storage unit, documentation requirements, and the exact corrective action process inspectors expect to see.
Proficiency testing is a federal requirement for all CLIA-certified laboratories performing non-waived testing. This guide covers PT enrollment requirements, acceptable performance criteria, and how to write a PT corrective action that satisfies CMS and CAP inspectors.
The 2022 revision of ISO 15189 introduced significant changes to risk management, point-of-care testing, and patient-focused requirements. Here is what every lab director needs to know.
A poorly written CAPA is one of the most common reasons laboratories receive repeat deficiencies at inspection. This guide shows you exactly how to structure a CAPA that demonstrates systematic problem-solving and satisfies every accreditation body.
A quality management system is the foundation of every accredited laboratory. This guide covers the essential elements of a laboratory QMS and how to build one that satisfies CAP, CLIA, ISO 15189, and COLA requirements.
Westgard rules are the foundation of clinical laboratory quality control. This guide explains each rule, when to apply it, and how to document QC violations to satisfy CAP, CLIA, and ISO 15189 inspectors.
Corrective and preventive action (CAPA) is required by every laboratory accreditation body. Learn how to write CAPAs that satisfy inspectors and actually fix the root cause.
Proficiency testing (PT) is required by CLIA for all non-waived tests. This guide covers PT enrollment, result submission, failure analysis, and corrective action requirements.
Choosing the right laboratory compliance software is a critical decision. This buyer's guide covers the essential features, questions to ask vendors, and red flags to avoid.
UK clinical laboratories seeking UKAS accreditation must comply with ISO 15189. This guide covers UKAS requirements, the accreditation process, and how to prepare for a UKAS assessment.
Australian clinical laboratories seeking NATA accreditation must comply with ISO 15189. This guide covers NATA requirements, the accreditation process, and how to prepare.
Clinical laboratories in the UAE and Saudi Arabia must meet specific accreditation requirements. This guide covers DHA, HAAD, CBAHI, SFDA, and ISO 15189 requirements for Middle East labs.
Clinical laboratories handle protected health information (PHI) and are subject to HIPAA. This guide covers HIPAA requirements for labs, common violations, and how to maintain compliance.
Document control is required by every laboratory accreditation body. Learn best practices for SOP management, version control, approval workflows, and record retention.
Artificial intelligence is beginning to transform laboratory compliance — from predicting inspection deficiencies to automating QC analysis. Here is what AI can and cannot do for your lab today.