11.4 Information to accompany results and data to maintain in records

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Worksheets can document the details of all samples being tested and the composition of the test during any given procedure. Recording details of all variables in any particular test or assay will allow analysis and development of trends which can aid in troubleshooting and in verifying the quality and performance of test procedures. A review of a laboratory’s raw data can be especially helpful during an on-site review for the WHO accreditation process for the GMRLN.

Worksheets can be paper-based system, where variables are recorded by hand on a printed worksheet. For an electronic system, worksheets may be generated from the computer and may be partially generated from the programme associated with the test/assay. Information to be recorded on a worksheet include:

  • Type of test/assay
  • Date of test performed, date of reporting results
  • Name of operator, name of person validating test
  • Lot numbers and expiry date of reagents/kits
  • Reagent concentration and identity of diluent(s)
  • Sample identification, treatment, condition, date of collection
  • Control sample details: ID, date, lot number, reference value
  • Validity of test/assay
  • Results: raw data, calculated values/units
  • Interpretation and final result to be reported
  • Comments: record of any issues with assay and how they were resolved
  • Attachments: Raw data print outs, digital images if generated

There are certain points in data handling when it is easy for transcription errors to occur, such as during manual transfer of data from patient history forms to worksheets or databases, keyboard data entry into a computerized information system, or data entry from worksheets to reports. The laboratory should put processes in place to safeguard against errors at these points.

Sometimes it may be necessary to adopt formal checking processes to ensure the accuracy of data recording and transmission of handwritten or keyed information. One example of a simple checking process is to always have two people review data transcription to verify its accuracy.

A common error occurs when the date format varies from a referring laboratory. Always request countries to specify the format their dates are recorded in, for example DD/MM/YYYY. Although some commonly used databases can be programmed to allow automatic conversion of date formats, error checking is still advisable.

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