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nchsls:c:biochemistry:document:common_laboratory_informations_related_to_the_examinations
^ 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 '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 | CLIA requirement ,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 | LIS | Monthly review of uncertainty analysis}} |
| biological reference intervals or clinical decision values | 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 LIS | |
| 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 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 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 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. Record and review laboratory performance before starting the examination and periodically there after |
nchsls/c/biochemistry/document/common_laboratory_informations_related_to_the_examinations.txt · Last modified: 2022/08/13 07:34 (external edit)
