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| Both sides previous revision Previous revision Next revision | Previous revision | ||
| quality_manual [2025/01/27 04:17] – admin | quality_manual [2025/02/06 06:24] (current) – admin | ||
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| - | =====Header===== | + | =====Header===== |
| ^Name^Unique ID^Edition^Date of Edition^ | ^Name^Unique ID^Edition^Date of Edition^ | ||
| |Quality Manual|LSSTH/ | |Quality Manual|LSSTH/ | ||
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| The information will include as appropriate: | The information will include as appropriate: | ||
| - The location(s) of the laboratory, operating hours and contact information; | - The location(s) of the laboratory, operating hours and contact information; | ||
| - | - The procedures for requesting and the collection of samples; | + | - The procedures for requesting and the collection of samples; |
| - The scope of laboratory activities and time for expected availability of results; | - The scope of laboratory activities and time for expected availability of results; | ||
| - The availability of advisory services; | - The availability of advisory services; | ||
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| ===7.2.3.2 Oral requests=== | ===7.2.3.2 Oral requests=== | ||
| - | The laboratory will have a procedure for managing oral requests for examinations, | + | The laboratory will have a procedure for managing oral requests for examinations, |
| ===7.2.4 Primary sample collection and handling=== | ===7.2.4 Primary sample collection and handling=== | ||
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| ===7.2.4.1 General=== | ===7.2.4.1 General=== | ||
| - | The laboratory will have procedures for the collection and handling of primary samples. | + | The laboratory will have procedures for the collection and handling of primary samples. |
| Information will be available to those responsible for sample collection. Any deviation from the established collection procedures will be clearly recorded. The potential risk and impact on the patient outcome of acceptance or rejection of the sample will be assessed, recorded and shall be communicated to the appropriate personnel. The laboratory will periodically review requirements for sample volume, collection device and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte. | Information will be available to those responsible for sample collection. Any deviation from the established collection procedures will be clearly recorded. The potential risk and impact on the patient outcome of acceptance or rejection of the sample will be assessed, recorded and shall be communicated to the appropriate personnel. The laboratory will periodically review requirements for sample volume, collection device and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte. | ||
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| ==7.2.6.1 Sample receipt procedure== | ==7.2.6.1 Sample receipt procedure== | ||
| - | The laboratory will have a procedure for sample receipt [[Procedure for sample receipt]][[https:// | + | The laboratory will have a procedure for sample receipt [[Procedure for sample receipt]]that includes: |
| - the unequivocal traceability of samples by request and labelling, to a uniquely identified patient and when applicable, the anatomical site; | - the unequivocal traceability of samples by request and labelling, to a uniquely identified patient and when applicable, the anatomical site; | ||
| - Criteria for acceptance and rejection of samples; | - Criteria for acceptance and rejection of samples; | ||
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| ==7.2.7.1 Sample protection== | ==7.2.7.1 Sample protection== | ||
| - | The laboratory will have procedures and appropriate facilities for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage. | + | The laboratory will have procedures and appropriate facilities for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage. [[Documentary Procedures for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage]] |
| ==7.2.7.2 Criteria for additional examination requests== | ==7.2.7.2 Criteria for additional examination requests== | ||
| Laboratory procedures will include time limits for requesting additional examinations on the same sample. | Laboratory procedures will include time limits for requesting additional examinations on the same sample. | ||
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| ===7.3.1 General=== | ===7.3.1 General=== | ||
| - | 1. The laboratory will select and use examination methods which have been validated for their intended use to assure the clinical accuracy of the examination for patient testing. | + | 1. The laboratory will select and use examination methods which have been validated for their intended use to assure the clinical accuracy of the examination for patient testing. |
| - | + | ||
| **NOTE:** Preferred methods are those specified in the instructions for use of in vitro diagnostic medical devices or those that have been published in established/ | **NOTE:** Preferred methods are those specified in the instructions for use of in vitro diagnostic medical devices or those that have been published in established/ | ||
| Line 921: | Line 919: | ||
| ===7.3.2 Verification of examination methods=== | ===7.3.2 Verification of examination methods=== | ||
| + | [[DP for Verification of examination methods]] | ||
| - The laboratory will have a procedure to verify that it can properly perform examination methods before introducing into use, by ensuring that the required performance, | - The laboratory will have a procedure to verify that it can properly perform examination methods before introducing into use, by ensuring that the required performance, | ||
| - The performance specifications for the examination method confirmed during the verification process will be those relevant to the intended use of the examination results. | - The performance specifications for the examination method confirmed during the verification process will be those relevant to the intended use of the examination results. | ||
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| Biological reference intervals and clinical decision limits will be defined, and their basis recorded, to reflect the patient population served by the laboratory, while considering the risk to patients. {{https:// | Biological reference intervals and clinical decision limits will be defined, and their basis recorded, to reflect the patient population served by the laboratory, while considering the risk to patients. {{https:// | ||
| + | [[Biological Reference Interval]] | ||
| **NOTE:** Biological reference values, provided by the manufacturer can be used by the laboratory, if the population base of these values is verified and deemed acceptable by the laboratory | **NOTE:** Biological reference values, provided by the manufacturer can be used by the laboratory, if the population base of these values is verified and deemed acceptable by the laboratory | ||
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| {{https:// | {{https:// | ||
| {{https:// | {{https:// | ||
| + | [[Documentary Procedure for validation of examination of result]] | ||
| a) The laboratory will have an IQC procedure for monitoring the ongoing validity of examination results, according to specified criteria, that verifies the attainment of the intended quality and ensures validity pertinent to clinical decision making. | a) The laboratory will have an IQC procedure for monitoring the ongoing validity of examination results, according to specified criteria, that verifies the attainment of the intended quality and ensures validity pertinent to clinical decision making. | ||
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| ==7.3.7.3 External quality assessment (EQA)== | ==7.3.7.3 External quality assessment (EQA)== | ||
| - | |||
| - | {{https:// | ||
| {{https:// | {{https:// | ||
| {{https:// | {{https:// | ||
| + | [[Procedure for Storage, Preparation, | ||
| a) The laboratory will monitor its performance of examination methods, by comparison with results of other laboratories. This includes participation in EQA programmes appropriate to the examinations and interpretation of examination results, including POCT examination methods. | a) The laboratory will monitor its performance of examination methods, by comparison with results of other laboratories. This includes participation in EQA programmes appropriate to the examinations and interpretation of examination results, including POCT examination methods. | ||
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| ==7.4.1.2 Result review and release== | ==7.4.1.2 Result review and release== | ||
| - | Results will be reviewed and authorized prior to release. The laboratory will ensure that authorized personnel review the results of examinations and evaluate them against IQC and, as appropriate, | + | Results will be reviewed and authorized prior to release. The laboratory will ensure that authorized personnel review the results of examinations and evaluate them against IQC and, as appropriate, |
| ==7.4.1.3 Critical result reports== | ==7.4.1.3 Critical result reports== | ||
| - | {{https:// | + | [[7.4.1.3_critical_values|]]{{https:// |
| When examination results fall within established critical decision limits: | When examination results fall within established critical decision limits: | ||
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| === 7.4.2 Post-examination handling of samples === {{ https:// | === 7.4.2 Post-examination handling of samples === {{ https:// | ||
| - | }} | + | }}[[Documentary Procedures for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage]] |
| The laboratory will specify the length of time samples are to be retained following examination and the conditions under which samples are to be stored. The laboratory will ensure that after the examination, | The laboratory will specify the length of time samples are to be retained following examination and the conditions under which samples are to be stored. The laboratory will ensure that after the examination, | ||
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| ====7.5 Nonconforming work==== | ====7.5 Nonconforming work==== | ||
| - | The laboratory will have a process for when any aspect of its laboratory activities or examination results do not conform to its own procedures, quality specifications, | + | The laboratory will have a process for when any aspect of its laboratory activities or examination results do not conform to its own procedures, quality specifications, |