Is there a documented program to ensure 6.4 that each person performing POCT maintains satisfactory levels of competence? Does the laboratory director oversee the 6.5 POCT program? Does the POCT program have an 6.6 organizational structure defining levels of responsibility? 7.0 TESTING Calibration The set of operations that – establish, under specified conditions, the 7.1 relationship between reagent system and the corresponding concentration value of an analyte. Does the POCT program follow 7.1.1 manufacturer’s instructions for calibration? Are the calibration results documented? 7.1.2 Linearity– The range of analyte values that a method can directly measure on the 7.2 specimen without any dilution, concentration or other pre-treatment not part of the usual assay process. Is the linearity validated for all POCT? 7.2.1 Is the linearity validation documented? 7.2.2 Does the POCT program have a procedure 7.2.3 for when results fall outside of the linear range? 8.0 Gas If blood gas analysis is performed outside of 8.1 the laboratory, is it under the supervision of the laboratory? Where are blood gas analyzers located 8.2 within the facility: Nursing stations 8.2.1 Emergency 8.2.2 Operating room 8.2.3 Intensive Care Unit 8.2.4 Neonatal 8.2.5 Outpatient areas 8.2.6 Other : 8.2.7
6.4 Is there a documented program to ensure that each person performing POCT maintains satisfactory levels of competence? 6.5 Does the laboratory director oversee the POCT program? 6.6 Does the POCT program have an organizational structure defining levels of responsibility? 7.0 TESTING 7.1 Calibration – The set of operations that establish, under specified conditions, the relationship between reagent system and the corresponding concentration value of an analyte. 7.1.1 Does the POCT program follow manufacturer’s instructions for calibration? 7.1.2 Are the calibration results documented? 7.2 Linearity– The range of analyte values that a method can directly measure on the specimen without any dilution, concentration or other pre-treatment not part of the usual assay process. 7.2.1 Is the linearity validated for all POCT? 7.2.2 Is the linearity validation documented? 7.2.3 Does the POCT program have a procedure for when results fall outside of the linear range? 8.0 Gas 8.1 If blood gas analysis is performed outside of the laboratory, is it under the supervision of the laboratory? 8.2 Where are blood gas analyzers located within the facility: 8.2.1 Nursing stations 8.2.2 Emergency 8.2.3 Operating room 8.2.4 Intensive Care Unit 8.2.5 Neonatal 8.2.6 Outpatient areas 8.2.7 Other :
CRA-F-05-15189-S-09-Point-of-Care%20Testing%20Inspection%20Checklist.docx