Author:Kurt Michael / Document Number: / Inf30-01
Effective (or Post) Date: / 1 Jan 2006
Review History / Date of last review: / 23 July 2010
Reviewed by: / Penny Stevens
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE.

EXAMPLES of RESULT REPORTING

Reporting of Results
1)
2)
3)
4) / The following areas are used to monitor the accuracy of released results and document corrective actions, if necessary:
  1. Compare result reporting vs. bench worksheet and/or instrument printout for discrepancies
  2. Monitor modified results, notification, frequency, approval, corrective steps taken
  3. Panic level determination & notification documentation
  4. Population normal ranges

Result modification / Amendment
1)
2)
3) /

An incorrect result needs to be modified and the correct result entered. Discrepancies are resolved immediately

1.All modified results must be brought to the attention of the ordering physician/clinic and documented.

2.The modified report must include the initials of the technologist and the lab supervisor as well as a brief explanation if appropriate

  1. Modified (amended) reports will be documented under the quality assurance monitoring.

Result Reporting Change
1)
2) /
  1. Changes in test methodology and /or reference ranges must be communicated to the ordering staff by a lab note or department memo.
  2. Changes must also be reported to the associated study administrators, as changes may have an effect on data analysis or safety reporting requirements.

EXAMPLE of Result Reporting

5.3.1.Result Reporting:

5.3.1.1.Initials of the person(s) who performed the test will be on the report, i.e on manual lab slip.

5.3.1.2.Criteria are established to report all critical test results to the physician ordering the test see individual assay SOP.

5.3.1.3.The laboratory supervisor, laboratory officer, will check all test results performed by trained personnel.

5.3.1.4.A copy of the test result should be maintained for at least two years

5.3.2.Result Review

5.3.2.1.The technologist/technicians performing the test will review all Instrument result print outs and sign off daily, the section head will review the results weekly and the lab supervisor and or the Laboratory officer will review monthly. Review of this documentation will occur to determine is any errors have occurred.
Daily the lab Supervisor will review quality control in the lab and initial/ date all forms that are reviewed ( compliance with College of American Pathologist Standards)

5.3.2.2.The following are general guidelines for each section:

Example of Critical Action Reporting

5.7.Critical Value Reporting

5.8.1.Communication of critical values will be reported verbally. The responsible personnel will notify the clinical investigator. If the clinical investigator is not available, site physician, site nurse, or clinical lab officer will be notified.

5.8.2.The laboratory personnel will document the critical value with date, time the critical value was encountered, the lab test, repeat of critical vale, name of the notifying personnel, and initial of responsible individual receiving critical results.All critical values will be placed in a folder and given to primary investigator or designee at the end of the day. Problems encountered in critical value notification will be referred immediately to the laboratory supervisor.

Modified Results Documentation Log for SOP Files

Lab NAME
Department / SOP No:
Supersedes: N/A
Effective Date:
Date/Time of original result / Patient Number / Test analyte / Old Result / Date/Time of new result / New Result / Date/Time contacted / Dr Contacted / Contacting tech Signature / Updated CRF / CRF amended by Signature