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               Documented Procedure for review and release of reports

Purpose: To manage post analytical processes in relation to the review, reporting and release of test results in clinical biochemistry Laboratory.

Responsibility: Laboratory technician, Resident doctors, authorized person, Section In charge

Review of all the reports are done manually by the authorized personnel.

Authorized personnel have responsibility to carry out following procedure

1. Review of patients report against IQC results
2. Review of patients report against Clinical History.
3. Review of patients report against Previous result.
4. Review of patients results with other parameter results of the same patient.
5. combination of all these information

Authorized personnel have responsibility to take decision

1. Release examination result for reporting
2. Repeat examination
3. Ask for repeat sample collection

See the graphs of each test one by one as the results are given by instrument. Following should be noted in Graphs,

1. OD
2. Pattern of graph.Any unusual presentation like,spike,reverse pattern of reaction direction,not achieving equilibrium, reaction curve is not linear in reading period.
3. Flag of test result.in case of any dilution, see the graph of before & after dilution.

Use following review criteria

1. If Result of potassium is very high - Check for sample hemolysis

In hemolyzed samples Potassium, SGOT, LDH, Total protein result will be High because RBC have higher concentration of these analytes as compared to serum. In hemolyzed samples Billirubin can be low as high Hb concentration breaks the azobilirubin complex.

1. High direct bilirubin in samples from neonatal ward should be informed to the doctor
2. If Total & Direct billirubin have the same value- give Indirect billirubin Below detection limit.
3. If the instrument is showing results as a less than value that means the patient's result for that analyte is below the detection limit of the instrument. For example Creatinine is <0.6 report it as a below detection limit of instrument.
4. If Creatinine below 0.6 - First check the result of Bilirubin. If It is < 15 mg/dl,give result as below detection.If it is > 15 mg/dl ,give comment that creatinine reporting cannot be done as a Hyperbillirubinemia Interfere with creatinine estimation.Comment: “Received sample is highly icteric. So, only limited Biochemistry is possible due to technical reason of methodology.”
5. If High potassium and low calcium- Check the blood clot in the vacutte, sample will not be clotted properly if EDTA contamination is there, call the doctor for transfer of sample from flouride or EDTA to plain vacutte & If transfer of sample was done then add comment ‘sample is rejected and send the repeat sample’.
6. If report of any patient having low value for all the analyte- Check the sample for proportion of cell part & serum, sample sample may be diluted
7. If the sample is highly lipemic- Verify the fasting status of the patient, if not ask for the fasting sample. Lipemic sample is due to high Triglyceride which is seen in Diabetic ketoacidosis. add comment ‘sample is highly lipemic, test can not be performed.’
8. If received any fluid sample which is thick in consistency, because of that aspiration of sample in the pipette is not possible. Add comment:
9. “As the sample is Heavily viscus, technically biochemistry parameter analysis is not possible. Highly turbid indicates the possibility of a high amount of pus cells or fibrin or proteins present in fluid. Kindly correlate clinically and send sample again.”
10. If Total Calcium < 8.6 or > 10.2 - Perform Albumin & give corrected Calcium value by following formula. Corrected Calcium = Measured total S. Calcium+ 0.8 (4 - Albumin)
11. If CSF microprotein result is > 600 mg/dl Perform the CSF protein estimation from The Total Protein Kit. The obtained result will be multiplied by 1000 since total protein is measured in gm/dL and CSF protein is estimated in mg/dL.
12. If UIBC is 0 OR Negative then add the remark as “UIBC below detection so TIBC can not be calculated and correlated clinically for any recent oral and parenteral iron therapy”.
13. If a variant window is detected on the HPLC graph, give the following comment. “An abnormal HPLC graph pattern has been found which might be caused by Hemoglobin D, Hemoglobin E & Hemoglobin S. As a result, the HbA1c result can not be accurately measured.
14. If area under curve is less than 3.5 lakh in HPLC Graph give following remarks. “Patient seems to be severely anemic so HbA1c reporting is technically not possible.

For compromised sample: If Sample is compromised like Inadequate sample, presence of interfering substance, icteric sample, lipemic sample, viscous sample , the authorized personnel will review, inform the concerned physician and after taking necessary action report will be released as compromised report with necessary remarks or sample may be rejected. Record:In case of sample rejection Maintain the record of rejection in soft copy attached here. Sample Rejection Record

For reporting of Critical Result: The test result of the parameters is in the critical range defined by the laboratory 7.4.1.3 Critical values7.4.1.3 Critical values The authorized personnel will review, inform the concerned physician and after taking necessary action, the report will be released as a critical report with necessary remarks. Above procedure will be documented in the critical alert register (Hard copy).

For Interim report: If authorized personnel are not available then the reports will be released as interim (provisional) reports, Final report will be provided if asked by requesting doctor or patient, or if there is a major discrepancy in between interim and final report.

Amendments to reported results The report requires revision, like in case of typographical error, sample run from vaccutte with wrong unique ID, due to systematic/random error, the authorized personnel will review, inform the concerned physician/user/patient and after taking necessary action report will be released as revised report with remarks of revision and reason of Amendments. Records: Both the reports are stored in the Amendments report file (Hard copy).

All reported results with patients demographic data of the last two years in the Laboratory Information System as a soft copy. LIS BACKUP