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quality_manual [2025/01/29 06:26] – adminquality_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/A/Central/P/8.3/1| 1 | 01-03-2023|    |Quality Manual|LSSTH/A/Central/P/8.3/1| 1 | 01-03-2023|   
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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. [[Documentary Procedure for Validation & Verification of  examination methods]] + 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/authoritative textbooks, peer-reviewed texts, or journals, or in international and national consensus standards or guidelines, or national or regional regulations. **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/authoritative textbooks, peer-reviewed texts, or journals, or in international and national consensus standards or guidelines, or national or regional regulations.
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 ===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, as specified by the manufacturer or method, can be achieved.   - 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, as specified by the manufacturer or method, can be achieved.
   - 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://docs.google.com/spreadsheets/d/14EYVZZ319vrkWjglrR6lMTO9gY5H101K/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Biological Reference Interval}} 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://docs.google.com/spreadsheets/d/14EYVZZ319vrkWjglrR6lMTO9gY5H101K/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Biological Reference Interval}}
 +[[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://drive.google.com/drive/folders/1HoEjDwAo4eTkVXzHEW3cRDpikJcD3lPX?usp=drive_link| LJ Semi, Electrolyte, ABG}} {{https://drive.google.com/drive/folders/1HoEjDwAo4eTkVXzHEW3cRDpikJcD3lPX?usp=drive_link| LJ Semi, Electrolyte, ABG}}
 {{https://docs.google.com/spreadsheets/d/1-nPoy9GocIFE-uPgR7dhmIscpc2_u4Cq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Abbott Calibration File}} {{https://docs.google.com/spreadsheets/d/1-nPoy9GocIFE-uPgR7dhmIscpc2_u4Cq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Abbott Calibration File}}
 +[[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://docs.google.com/document/d/1BzHs1ThpIlcTcWFsVWP9M-ZH1mta6zg8GxWjFm-UHuI/edit?usp=drive_link|7.3.7.3 Procedure for Storage, Preparation, Analysis, Result submission, RCA & Modification in EQAS}} 
  
 {{https://drive.google.com/file/d/1xqAM5lQqi_sbLSHGOd-uRU_Q_12nHv9w/view?usp=drive_link| EQAS Evaluation Criteria}} {{https://drive.google.com/file/d/1xqAM5lQqi_sbLSHGOd-uRU_Q_12nHv9w/view?usp=drive_link| EQAS Evaluation Criteria}}
  
 {{https://drive.google.com/drive/folders/1Ooqpnp3e8XUepdRu39WEJSbR960ozkEK?usp=drive_link| RIQAS Results}} {{https://drive.google.com/drive/folders/1Ooqpnp3e8XUepdRu39WEJSbR960ozkEK?usp=drive_link| RIQAS Results}}
 +[[Procedure for Storage, Preparation, Analysis, Result submission, RCA & Modification in EQAS]]
 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, available clinical information and previous examination results. Responsibilities and procedures for how examination results are released for reporting, including by whom and to whom, will be specified.{{https://docs.google.com/document/d/12V1VO7GpjHiwejVVpq6KjYYXb4uS_6flw7-tfHMWMv8/edit?usp=drive_link|Procedure for review & release of reports}}+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, available clinical information and previous examination results. Responsibilities and procedures for how examination results are released for reporting, including by whom and to whom, will be specified.[[Procedure for review & release of reports]]
  
 ==7.4.1.3 Critical result reports== ==7.4.1.3 Critical result reports==
  
-{{https://docs.google.com/document/d/1eIJ7Q0NoeO6lga92Gta9-jlC-ERzU5fa/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Critical values}}{{https://docs.google.com/document/d/1nqDQwiSYg6gbMLmVhjP51DZwi13jqchU/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Format Critical value register}}+ [[7.4.1.3_critical_values|]]{{https://docs.google.com/document/d/1nqDQwiSYg6gbMLmVhjP51DZwi13jqchU/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Format Critical value register}}
  
 When examination results fall within established critical decision limits: When examination results fall within established critical decision limits: