CLIA Laboratory Compliance manual: Quality-System Frameworks, Proficiency-Testing Documentation,Personnel-Competency, Procedure-Manual Architecture, and Survey-Readiness Tools for Clinical Laboratory
Kindle Edition or EPUB + Converted PDF نویسندگان: Adrian Hartwell
جزئیات
فرمت: Kindle Edition or EPUB + Converted PDF تاریخ انتشار نسخه الکترونیکی : July 19, 2026
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لینک: https://www.amazon.com/dp/B0H9HC9MSX
17,678,000 تومان
زمان تحویل: حداکثر 24 ساعت
توضیحات
Build a CLIA compliance program you can document, audit, and defend — without hiring a consultant for every form.If you direct a moderate- or high-complexity clinical laboratory, the requirements never sit still: personnel qualifications, six-element competency, proficiency testing, written procedures, quality control, individualized quality control plans, document control, corrective action, and survey evidence. When a surveyor asks a simple question, the answer is usually somewhere — scattered across binders, drives, and personnel files. This manual turns that scramble into a system.An operating system, not a summaryEvery chapter connects a regulatory duty to the responsible role, the controlled document that proves it, its review cycle, its retention period, and exactly where the evidence lives. You build one Regulation-to-Evidence Crosswalk, then fill it in for each part of the laboratory.What you getA complete six-element competency system — forms, calendars, assessor checks, a completed example, remediation and reassessment.A full proficiency-testing lifecycle — enrollment through director review, failure investigation, effectiveness, and a referral-prevention checklist for CLIA's most dangerous mistake.A §493.1251 procedure-manual architecture mapping all fourteen required elements, with a complete worked procedure.Quality-control, quality-assessment, and IQCP tools built around the real testing cycle.A survey-ready evidence room — index, document-request tracker, interview preparation, and documented director oversight.A corrective-action engine that fixes the process, not just the paperwork, and a completed plan-of-correction example.48 build-ready tools — SOPs, forms, logs, checklists, decision trees, and reference tables — reproduced blank in a master library, each with customization fields.Careful where it countsThe manual separates binding regulation from nonbinding guidance, flags requirements that changed recently, marks date-controlled items to verify against the current source, and points you to professional help at the moments that call for it. It is an independent professional reference — not legal advice, and no template is presented as a guarantee of compliance.Written for laboratory directors, quality managers, technical supervisors, technical consultants, general supervisors, and compliance staff who would rather build it right than rebuild it after a survey.
17,678,000 تومان
زمان تحویل: حداکثر 24 ساعت