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quality_manual [2025/01/30 05:08] – 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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 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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 ==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: