THE DEFINITIVE REFERENCE TO LABORATORY QUALITY MANAGEMENT: CLIA Compliance, Accreditation Standards, and Continuous Improvement Systems by Margaret Ellsworth

When compliance pressure hits, this is the reference you want open on your desk. Laboratory quality management is no longer a side task you handle between inspections. It is the operating system behind every accurate result, every defensible record, and every survey response that protects your laboratory from avoidable findings. When CLIA obligations, CAP checklist expectations, TJC survey demands, ISO 15189 requirements, personnel competency rules, PT performance, document control, and corrective action systems start colliding at once, most professionals do not need more theory. They need a practical answer they can use today. Built for people who carry the work. This book is written for laboratory directors, quality managers, compliance officers, technical supervisors, and section leaders who are responsible for keeping systems inspection-ready while still running a real laboratory. It does not talk around the problem. It shows what good compliance looks like in practice, what weak documentation looks like before an inspector cites it, and what to do next when a gap is already on your desk. Read more