Internal QA Test Case Validation Checklist

Diagnostic labs & pathology

5.1 Personnel
Are educational qualifications, professional experience, and related HR records maintained for all staff?
Is an updated Job Description (JD) available for each employee with HR?
Does HR maintain the joining letter with employee’s Ethics & Patient Confidentiality declaration?
Are induction training records documented for every new hire?
Is training on sample accession documented for all staff?
Is on-the-job/departmental training record maintained for staff?
Is LIS (Laboratory Information System) training record maintained for all employees?
Has QMS (Quality Management System) training been conducted for all staff?
Are company-issued certificates of instrument-specific training available for relevant staff?
Is instrument-specific competency documentation available for all staff?
Are competency assessments for new joinees conducted after one month of joining?
Is practical competency of new joinees evaluated and recorded after one month?
Is direct observation of new joinees recorded after 6 months of joining?
Is 6-month competency record maintained for new employees?
Is annual competency assessment available for all staff?
Is annual practical competency record maintained for all staff?
Is annual direct observation record available for staff?
Are competency assessments for new pathologists documented?
Is annual competency record maintained for all pathologists?
Is an updated training checklist available for all pathologists?
Have technicians with more than 2 years of service completed CAP competency, with certificates filed?
Are CAP competency Q&A hard copies filed for new staff?
Have staff enrolled in CAP learning/error case studies, with certificates recorded?
Have phlebotomists completed Upside LMS e-learning modules, with records maintained?
Is annual safety training record available for all staff?
Are retraining records maintained for staff deemed non-competent?
Is vision (color discrimination) testing done for staff whose work requires it?
Is annual health check-up done for microbiology and molecular staff?
Is Hepatitis B immunization documented for all staff (individual & summary)?
Is COVID vaccination record available for all employees?
Is Tetanus immunization record available for all employees?
Is CME (minimum 2 per month with questionnaire/QA mail) record available?
Is the circular file with Read & Understood signatures available for all staff?
Are records of accidents and occupational hazard exposures maintained?
Are technicians trained in microscopy?
Is competency assessment for microscopy training of technicians documented?

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