^  Common Laboratory Information Related to Examinations  ^^ 
^purpose|Refer to reference literature|
^principle,method|Refer to reference literature|
^performance characteristics-trueness|Refer to reference literature. These are characteristic performance found during validation. Refer them to compare laboratory performance of the examination during independent verification of examination|
^performance characteristics-accuracy|:::|
^performance characteristics-precision-within batch|:::|
^performance characteristics-precision-across batch|:::|
^performance characteristics-precision-across laboratory|:::|
^performance characteristics-uncertainty|:::|
^performance characteristics-specificity,interference|:::|
^performance characteristics-sensitivity|:::| 
^performance characteristics-detection limit|:::|
^performance characteristics-quantitation limit|:::|
^performance characteristics-measuring interval|:::|
^performance characteristics-diagnostic specificity|:::|
^performance characteristics-diagnostic sensitivity|:::|
^type of sample|Refer to reference literature. Make appropriate entry in the [[http://10.207.3.240/view_scope.php|'scope' table of LIS]]|
^patient preparation|:::|
^container,additives|:::|
^pre-examination sample temperature|:::|
^Maximum duration from sample collection to examination|:::|
^time limits for requesting it as additional examination|:::|
^required equipment and reagents|Refer to reference literature. Write specific procedures in individual examination procedures, where required|
^environmental and safety controls|:::|
^calibration procedures (metrological traceability)|:::|
^procedural steps|:::|
^quality control procedures|:::|
^Calculation of results|:::|
^instructions for determining quantitative results when a result is not within the measurement interval|:::|
^interferences|Refer to reference literature.|
^performance requirements for the measurement uncertainty|{{:nchsls:c:biochemistry:document:03_clia.pdf|CLIA requirement }},{{ :nchsls:c:biochemistry:document:updated_clia_requirement.pdf |updated CLIA reuirement
}}, https://datainnovations.com/allowable-total-error-table, [[https://www.westgard.com/consolidated-goals-chemistry.htm]], [[https://www.westgard.com/biodatabase1.htm]]|
^review of estimates of measurement uncertainty|[[HTTP://12.207.3.240|LIS]]|Monthly review of uncertainty analysis}}|
^biological reference intervals or clinical decision values|{{si_unit_conversion_into_usual_unit_calculation.xls|Following table describe relationship between usual laboratory unit and SI unit}}.Refer to reference literature. Make appropriate entry of values and sources of information in the [[http://10.207.3.240|LIS]]|{{si_unit_conversion_into_usual_unit_calculation.ods|}}
^alert/critical values, where appropriate|:::|
^Communication of biological reference intervals or clinical decision values and changes thereof to clinicians and users|Follow procedure described in [[nchsls:c:biochemistry:document:06|Procedure for informing patients and users about the laboratory services]]|
^reportable interval of examination results|Refer to reference literature. Make appropriate entry of values and sources of information in the [[http://10.207.3.240|LIS]]|.
^laboratory clinical interpretation|Refer to reference literature|
^potential sources of variation|Refer to reference literature.|
^references|Maintain reference literature for examinations in electronic/physical form in the laboratory or any place readily accessible to laboratory|
^Special work desk instructions|Maintain special work desk instructions for examinations in electronic/physical form in the laboratory|  
^Procedure to communicate change in procedure, effect on results or their interpretations.|Follow procedure described in [[nchsls:c:biochemistry:document:06|Procedure for informing patients and users about the laboratory services]]|
^Independent verification of examination procedure by the laboratory|Refer to reference literature to obtain information from the manufacturer/method developer for confirming the performance characteristics of the procedure. [[http://10.207.3.240/NCHSLS/c/001%20Biochemistry/Records/009%20Internal%20Quality%20Control%20Records|Record and review]] laboratory performance before starting the examination and periodically there after|