实验室的检验报告必须具备哪些必要的说明?

2025-04-09 19:14:13
推荐回答(2个)
回答1:

一下是CAP Checklist 中要求的报告元素。
GEN.41096 Phase II
Does the paper or electronic report include the following elements?

1. Name and address of testing laboratory (see note below)
2. Patient name and identification number, or unique patient identifier
3. Name of physician of record, or legally authorized person ordering test, as appropriate
4. Date and time of specimen collection, when appropriate
5. Date of release of report (if not on the report, this information should be readily accessible)
6. Time of release of report, if applicable (if not on the report, this information should be readily accessible)
7. Specimen source, when applicable
8. Test result(s) (and units of measurement, when applicable)
9. Reference intervals, as applicable (see Note below)
10. Conditions of specimen that may limit adequacy of testing

NOTE: The address of an outside reference laboratory may be on the report, or available in other records from the reporting laboratory. A “reference laboratory” includes outside reference laboratories as well as any affiliated or special function laboratory that is separately accredited and has a different CLIA-88 registration number than the referring laboratory. The address of the reporting laboratory should be on the report.

Under some circumstances it may be appropriate to distribute lists or tables of reference intervals to all users and sites where reports are received. This system is usually fraught with difficulties, but if in place and rigidly controlled, it is acceptable.

Patient reports must state the name of the physician (or other legally authorized person) ordering the test(s) or a physician of record. In those institutions where there are multiple ordering physicians and/or frequent changing of attending physicians, the ordering physician should be easily identifiable through a computer audit trail or other records of the test order.

回答2:

具体参考iso17025的关于报告的技术要素,都列全了。