3.0 Specimen Collection Manual Is a specimen collection manual available at 3.1 all collection sites? Does the specimen collection manual include: 3.2 Patient preparation 3.2.1 Specimen type and amount (ie. midstream) 3.2.2 Proper handling (ie. Preservative 3.2..3 /anticoagulant) Labelling with patient and last name and 3.2.4 other identification Are there written criteria for specimen 3.2.5 rejection? Reagents 4.0 Are all reagents used within expiry date? 4.1 Are all reagents used according to 4.2 manufacturer’s instructions? Are all reagents labelled with: 4.3 Date of receipt 4.3.1 Date prepared or opened 4.3.2 Expiry date 4.3.3 Content and concentration 4.3.4 Are all reagents stored according to 4.4 manufacturer’s instructions? Are common interferences evaluated for all analytes measured with each reagent system or 4.5 is credible manufacturer’s information available? If are multiple components of a reagent kit, does the laboratory use components of 4.6 reagent kits only within the same kit lot, unless otherwise specified by the manufacturer? Prior to use, are new reagent lots checked 4.7 against old reagent lot? Instruments and Equipment 5.0 Is there a procedure for maintenance of all 5.1 instruments and equipment? Are the maintenance records reviewed by a 5.2 supervisor?
3.0 Specimen Collection Manual 3.1 Is a specimen collection manual available at all collection sites? 3.2 Does the specimen collection manual include: 3.2.1 Patient preparation 3.2.2 Specimen type and amount (ie. midstream) 3.2..3 Proper handling (ie. Preservative /anticoagulant) 3.2.4 Labelling with patient and last name and other identification 3.2.5 Are there written criteria for specimen rejection? 4.0 Reagents 4.1 Are all reagents used within expiry date? 4.2 Are all reagents used according to manufacturer’s instructions? 4.3 Are all reagents labelled with: 4.3.1 Date of receipt 4.3.2 Date prepared or opened 4.3.3 Expiry date 4.3.4 Content and concentration 4.4 Are all reagents stored according to manufacturer’s instructions? 4.5 Are common interferences evaluated for all analytes measured with each reagent system or is credible manufacturer’s information available? 4.6 If are multiple components of a reagent kit, does the laboratory use components of reagent kits only within the same kit lot, unless otherwise specified by the manufacturer? 4.7 Prior to use, are new reagent lots checked against old reagent lot? 5.0 Instruments and Equipment 5.1 Is there a procedure for maintenance of all instruments and equipment? 5.2 Are the maintenance records reviewed by a supervisor?
CRA-F-05-15189-S-02-Chemistry%20Inspection%20Checklist.docx