ORIGINAL ARTICLE Conformity evaluation checklists of API 20 E … 20 E... · Figure S2. API 20 E conformity evaluation checklist for reagents (n = 2).These API 20 E reagents require

ORIGINAL ARTICLE

Conformity evaluation checklists of API 20 E for ISO 15189:2012 internal auditing: an optimisation tool for medical laboratories

Supplementary material

Dennis Mok1, Rana Nabulsi2 and Sharfuddin Chowdhury3

1Medical Management Consulting, Birkdale, Australia, 2Dubai Health Authority, Dubai, United Arab Emirates and 3King Saud Medical City, Riyadh, Saudi Arabia

‡ The evaluation of ‘NIT 1 and NIT 2’ consists of two reagents: NIT 1 (acetic acid and sulfanilic acid in water) and NIT 2 (N,N-dimethyl-1-naphthylamine and acetic acid in water). § The evaluation of ‘VP 1 and VP 2’ consists of two reagents: VP 1 (potassium hydroxide in water) and VP 2 (-naphtol in ethanol). Figure S1. API 20 E conformity evaluation checklist for reagents (n = 4). These API 20 E reagents can utilise third-party commercially available quality control kits to support the verification process.

NOTE 1. The first column entitled ‘Reagents’ requires the internal auditor to enter the following information from records concerning the API 20 E reagents: ‘Batch code’ and ‘Use by date’ in the blue-shaded area. The second column entitled ‘Negative control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the API 20 E strip in the blue-shaded area; the quality control material in the yellow-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area. The third column entitled ‘Positive control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ information of the API 20 E strip in the blue-shaded area; the quality control material in the yellow-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area. The last column entitled ‘Acceptability’ requires the internal auditor to indicate: the grade of either ‘Acceptable’ or ‘Unacceptable’ in the blue-shaded area; and, the ‘Date’ that the evaluation was performed and the internal auditor’s ‘Person identification’ in the blue-bordered area. An acceptable result is applied when valid records are obtained in the first, second and third columns. NOTE 2. The recommended format for ‘Date’ and ‘Use by date’ is as specified in Subclause 4.1.2.2 of ISO 8601:2004.

Figure S2. API 20 E conformity evaluation checklist for reagents (n = 2). These API 20 E reagents require the medical laboratory to utilise its process for independent verification. NOTE 1. The first column entitled ‘Reagents’ requires the internal auditor to enter the following information from records concerning the API 20 E reagents: ‘Batch code’ and ‘Use by date’ in the blue-shaded area. The second column entitled ‘Negative control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the API 20 E strip in the blue-shaded area; the quality control material in the yellow-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area. The third column entitled ‘Positive control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the API 20 E strip in the blue-shaded area; the quality control material in the yellow-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area. The last column entitled ‘Acceptability’ requires the internal auditor to indicate the grade of either ‘Acceptable’ or ‘Unacceptable’ in the blue-shaded area; and, the ‘Date’ that the evaluation was performed and the internal auditor’s ‘Person identification’ in the blue-bordered area. An acceptable result is applied when valid records are obtained in the first, second and third columns.

NOTE 2. The recommended format for ‘Date’ and ‘Use by date’ is as specified in Subclause 4.1.2.2 of ISO 8601:2004.

Figure S3 (1 of 2).

Figure S3 (2 of 2). API 20 E conformity evaluation checklist for tests (n = 11). This checklist evaluates reactivities of tests subject to treatment with specified conditions of incubation (34 °C to 38 °C) and duration (18 h to 24 h) as well as reference equipment for monitoring the conditions.

NOTE 1. The first column entitled ‘Tests’ requires the internal auditor to enter the following information from records concerning the API 20 E strip tests: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ in the blue-shaded area.

The second column entitled ‘Negative control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; the treatment condition ‘Temperature limit’ and ‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.

The third column entitled ‘Positive control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; the treatment condition ‘Temperature limit’ and ‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.

The last column entitled ‘Acceptability’ requires the internal auditor to indicate: the grade of either ‘Acceptable’ or ‘Unacceptable’ in the blue-shaded area; and, the ‘Date’ that the evaluation was performed and the internal auditor’s ‘Person identification’ in the blue-bordered area. An acceptable result is applied when valid records are obtained in the first, second and third columns.

NOTE 2. The recommended format for ‘Date’ and ‘Use by date’ is as per specifications in Subclause 4.1.2.2 of ISO 8601:2004.

NOTE 3. Information considered valid to be recorded on the checklist only if the reference equipment meets the relevant conformance requirements for calibration as specified in ISO/IEC 17025:2017.

NOTE 4. The ‘Date’ that the evaluation was performed and the internal auditor’s ‘Person identification’ is presented once only in the last column in the blue-bordered, blue-shaded area.

Figure S4. API 20 E conformity evaluation checklist for tests (n = 5). This checklist evaluates reactivities of tests subject to application of the API 20 E reagent (Mineral Oil) and treatment with specified conditions of incubation (34 °C to 38 °C) and duration (18 h to 24 h) as well as reference equipment for monitoring the conditions.


The second column entitled ‘Negative control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; ‘Batch code’ and ‘Use by date’ of the API 20 E reagent (Mineral Oil) in the blue-bordered, blue-shaded area; the treatment condition ‘Temperature limit’ and ‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.

The third column entitled ‘Positive control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; ‘Batch code’ and ‘Use by date’ of the API 20 E reagent (Mineral Oil) in the blue-bordered, blue-shaded area; the treatment condition ‘Temperature limit’ and ‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.




Figure S5. API 20 E conformity evaluation checklist for tests (n = 3). This checklist evaluates reactivities of tests subject to application of the API 20 E reagents (JAMES, TDA as well as VP 1 and VP 2) and treatment with specified conditions of incubation and duration as well as reference equipment for monitoring the conditions.


The second column entitled ‘Negative control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; ‘Batch code’ and ‘Use by date’ of the API 20 E reagents (JAMES, TDA as well as VP 1 and VP 2) in the blue-bordered, blue-shaded area; the treatment condition ‘Temperature limit’ and ‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer(s) in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.

The third column entitled ‘Positive control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; ‘Batch code’ and ‘Use by date’ of the API 20 E reagents (JAMES, TDA as well as VP 1 and VP 2) in the blue-bordered, blue-shaded area; the treatment condition ‘Temperature limit’ and‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer(s) in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.




Figure S6. API 20 E conformity evaluation checklist for tests (n = 3). This checklist evaluates reactivities of tests subject to application of the API 20 E reagents (NIT 1 and NIT 2 as well as Zn) and treatment with specified conditions of incubation and duration as well as reference equipment for monitoring the conditions.


The second column entitled ‘Negative control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; ‘Batch code’ and ‘Use by date’ of the API 20 E reagents (NIT 1 and NIT 2 as well as Zn) if applied in the blue-bordered, blue-shaded area; the treatment condition ‘Temperature limit’ and ‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer(s) in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.

The third column entitled ‘Positive control’ requires the internal auditor to enter the following information from records: ‘Catalogue number’, ‘Batch code’ and ‘Use by date’ of the quality control material in the yellow-shaded area; ‘Batch code’ and ‘Use by date’ of the API 20 E reagents (NIT 1 and NIT 2 as well as Zn) if applied in the blue-bordered, blue-shaded area; the treatment condition ‘Temperature limit’ and ‘Serial number’ of the thermometer in the orange-shaded area; ‘Programmable start’ and ‘Serial number’ of the timer(s) in the orange-shaded area; and the ‘Date’ the activity was performed in the blue-shaded area.




Figure S7. Interpretation checklist of API 20 E conformity evaluation checklists. Final results can be presented for review at the completion of compilation of results.

NOTE 1. The last column entitled ‘Acceptability’ requires the internal auditor to indicate: the grade of either ‘Acceptable’ or ‘Unacceptable’ in the blue-shaded area; and, the ‘Date’ that the evaluation was performed and the internal auditor’s ‘Person identification’ in the blue-bordered area. An acceptable result is applied when the grade of ‘Acceptable’ is applied in the API 20 E conformity evaluation checklists (Figures S1 to S6).


Documents

ORIGINAL ARTICLE Conformity evaluation checklists of API 20 E … 20 E... · Figure S2. API 20 E conformity evaluation checklist for reagents (n = 2).These API 20 E reagents require