Institution Code:

Laboratory name Standard Operating Procedure (SOP) Version: no.

Location Date: of release
Head/Responsible person Reporting of test results Page: 1 of 9

1. Reporting of Test Results

2. Objectives and scope

This SOP describes the appropriate reporting of laboratory results from the
laboratory to the physician who requested the test or the Research Study contact
person through the laboratory’s supervisory chain. This will ensure that the result
reporting process is performed adequately and with appropriate quality control and
quality assurance in a manner that reduces errors or misreporting of results.

This SOP outlines critical values (Multi Drug Resistance, MDR and Extra Drug
resistance, XDR) and describes the reporting procedures.

This SOP applies to all laboratory staff, including QA unit, data unit, laboratory
manager and laboratory director

3. Abbreviations, definitions and terms

• N.A. Not Applicable

• QM Quality Manual
• SOP Standard Operating Procedure
• QA Quality Assurance Unit
• DST Drug Susceptibility Testing
• LJ Lowenstein-Jensen
• MGIT Mycobacteria Growth Indicator Tube
• AFB Acid-Fast Bacilli

4. Tasks, responsibilities and accountabilities

Task Responsible Accountable

Documenting Test result on (Worksheets, Lab techs Lab Manager
Laboratory books) completely and accurately
Review of test results on worksheets and lab Authorized Lab Manager
books reviewers
Ensure correct SOPs are followed while Lab Manager Lab Director
performing the tests and that test results are
valid and properly documented.
Ensure reports are accurately filled out and Data Admin Lab Manager
free from transcription inaccuracies before
final approval
Ensure that results are reported and sent to Data Admin Lab Manager
the appropriate people.
Final approval of results Lab Manager Lab Director
Results tracking done as results are Data Admin Lab Manager
generated, in the laboratory to ensure timely
reporting.
Right results are issued out to the right Data Admin Lab Manager

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Institution Code:
Laboratory name Standard Operating Procedure (SOP) Version: no.
Location Date: of release
Head/Responsible person Reporting of test results Page: 2 of 9

persons and signed up at collection and copies

kept for future reference
Filling out of Corrective Action Log, in the Responsible tech Lab Manager
event of assay failure.

5. Safety and environment

N.A.

6. Procedure

6.1 Reagents and Materials

N.A.

6.2 Review of Worksheets/Laboratory Registers

1. All procedure worksheets will be completed by the test operators as required by

the specific test procedures (SOPs).
2. The operators will check the test results and test validity and sign on the
worksheets.
3. The worksheets are then forwarded to the authorized reviewers, who specifically
look for the detection of clerical, analytical errors and unusual laboratory results.
4. If the review process reveals a failed test run, a corrective action log (See SOP
Corrective Action) must be filled out by the operator.
5. The reviewers approve test results and forward worksheets to data section for
entry.

6.3 Entry of Results in database

1. The data clerks will enter results forwarded to them by the authorized reviewers.
2. The person entering the result must verify that the result has been entered
correctly.
3. Data entered will consist of the following results.
a. Microscopy
b. Culture
c. DST
4. The data clerk will then print out preliminary results report
a. With AFB microscopy and/or positive cultures pending DST for (all studies
except for TSRS)
b. TC with AFB smear positive and HAIN results.
5. For results transmitted as preliminary report, the final report shall be forwarded.

6.4 Review of results report

1. The results report will be given to the reviewer and then the lab manager to
validate accuracy of information on report with raw data documents
(worksheets). The reports are signed and dated as proof of data review.

Source: GLI Stepwise Process towards TB Laboratory Accreditation

Institution Code:
Laboratory name Standard Operating Procedure (SOP) Version: no.
Location Date: of release
Head/Responsible person Reporting of test results Page: 3 of 9

6.5 Report forms

a. Report forms
1. Each report form includes (where relevant)
• Patient/client name and address
• Name and address of of the client/Health facility,
• Patient Identification number
• Sample quality, Date/time collected and received in the laboratory
• Name and address of the laboratory
• Clear and concise results of tests analyses
• Date/time of report issue
• Comment section
• Signature of title of the reviewer and Lab manager or authorized
deputy
2. Authorized Signatories
A controlled copy of the list of Approved Signatures is held by the Quality
manager whereupon the approving signatures for Reports can be
identified.

b. Logistics
1. All result reports have to be approved and signed by two authorities; the
technical reviewer and laboratory manager.
2. All generated report forms must go through a data accuracy check by the
data section and technical reviewer. Patient details are reviewed using the
request form. Technical reviewers use the reviewer guidelines.
3. The manager will review the comments on the reports to ensure that they
are accurate (e.g. quality or adequacy of primary sample which may have
compromised the results/interpretations.
4. The final report approval authority is the laboratory manager.
5. In the event that the laboratory manager is not available, the laboratory
delegated person will be authorized to complete the reporting process.

c. Copies and uncollected originals

1. For all result report forms, a photo-copy must be made.
2. The original will be sent to the physician/study that requested the test
while the photocopy will be kept at laboratory.
3. Uncollected originals will be filed at laboratory in a folder “Laboratory
Results for Dispatch” and communication will be made to the respective
parties such that results reports can be collected. The copy will be filed
according to laboratory number and in a chronological order.
4. Copies will be stored for at least 2 years before being removed. However
the laboratory will strive to retain these documents until archive space can
no longer allow. (refer to SOP Laboratory Data Archival)

d. Results report dispatch

1. The data clerks and the data administrator are responsible for issuing out
results to authorized personnel. The results for dispatch folder shall be
managed by the data section.

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Institution Code:
Laboratory name Standard Operating Procedure (SOP) Version: no.
Location Date: of release
Head/Responsible person Reporting of test results Page: 4 of 9

2. All results collected shall be photocopied and the original sent out while
the copy is retained at laboratory.
3. The collected/issued results shall be signed for in the “results dispatch
book” by the person picking up the results from laboratory.
4. It is the responsibility of the Data Administrator to ensure that all results
being issued are dully approved/signed and bear a laboratory stamp.

e. Guidelines for release of results directly to Patients

1. Under normal circumstances the laboratory is not supposed to release
results directly to the patients except in situations where the patient has
delivered the specimen and request form in person. If need arises the
case will be handled by the lab manager.

f. Quality Control
1. Laboratory test results
i. All test results and test validity are checked by test operator.
ii. Results are checked by authorized reviewers who specifically look
for the detection of clerical, analytical and unusual laboratory
results.
iii. The data reviewer verifies microscopy, culture and DST results
printed on report forms before forwarding to laboratory manager
for further approval.

2. Report forms
iv. 100% of reports are checked for accuracy of data and patient’s
information before results are sent out.

6.6 Procedures for immediate notification of MDR

a. Reporting Responsibility
1. The laboratory technician performing HAIN, MGIT and LJ DST are
responsible for bringing critical values (i.e MDR and XDR to the
IMMEDIATE attention of the laboratory Shipping Coordinator and/or lab
manager).
2. It is the responsibility of the Shipping coordinator to review the data for
the critical value and report to the appropriate person.
3. If the Shipping coordinator is not available, the critical value should be
reported to the lab manager.

b. Reporting Procedure
1. Critical values are MDR and XDR.
2. A contact list will be available in the beginning of the critical value log
notebook which lists the person and phone number to call, depending on
the clinic/study.
3. Once results have been verified and reviewed, the reporting person should
call the first person on the critical reporting list for the appropriate study.
4. Reporter should:
i. State that a critical value is being reported
ii. Give Patient Name and Patient ID of sample

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Institution Code:
Laboratory name Standard Operating Procedure (SOP) Version: no.
Location Date: of release
Head/Responsible person Reporting of test results Page: 5 of 9

iii. Give critical value (MDR or XDR)

iv. Get name of person critical value is reported to
5. Receiver of critical value must:
i. Repeat back patient Name and ID
ii. Critical Value
6. Once phone call is complete, reporter must fill out the critical value
reporting log, which is located in the laboratory (Appendix 1).

6.7 Turnaround Time

The
Method Expected TAT laboratory
Microscopy 2 working days endeavours to
LJ culture 9 weeks maximum keep its
MGIT culture 7 weeks maximum turnaround time
HAIN 3 days for tests as short
LJ DST 7 weeks as possible.
MGIT DST 14 days Turnaround times
are, however,
highly variable, depending on the type of test.

6.8 Notification of delayed examination to requester.

In cases where the results have been delayed to the to the extent that there is
significant compromise to patient care the lab manager will notify the requester
giving reasons for delay and the expected results date.

6.9 Results distributed by Telephone

It is not a policy of laboratory to report results using telephone except those

classified as critical values to authorized personnel. In the event that this has
occurred, the lab will follow up the verbal result with a properly recorded report
even in cases of critical values.

Telephones will also be used to send Short Message Service (SMS) to requesting
person in the peripheral labs by the data section. Microscopy, Culture and DST
results are sent out immediately they become available. A properly recorded
report follows.

6.10 Alteration of reports

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Institution Code:
Laboratory name Standard Operating Procedure (SOP) Version: no.
Location Date: of release
Head/Responsible person Reporting of test results Page: 6 of 9

1. If it is discovered that an erroneous result has been sent out to the physician, the
data section must notify laboratory manager or quality manager immediately.
2. If a new report is needed, the data section will generate a new report and mark it
as a “Corrected Report” and the erroneous report should be marked “erroneous
report.
3. Attach a memo to the new report, explaining reasons for the corrected report and
that date that the new report replaces.
4. Document error in corrective action log (CA log; see SOP Corrective Action). The
record must show the time, date and name of the person responsible for the
change. Original entries shall remain legible when alterations are made.
5. Maintain the CA log, a copy of the new and original report along with any
correspondence(s) to the physician or study that may arise.
6. File in the revised reports file.

7. Related documents

SOP Corrective Action

8. Related forms

N.A.

9. References

ISO 15189 Medical Laboratories – Particular requirements for quality and

competence
Quality Manual

10. Attachments / Annexes

Appendix 1, Critical value reporting log.

Appendix 2, Register of Approved Signatories

Source: GLI Stepwise Process towards TB Laboratory Accreditation

 Critical Value Reporting Log

Date Time Study Patient Name Patient ID # Value (MDR or Critical Value Critical Value Reported to: Time value Reporter
XDR) Read back by (name) reported Initials
clinic (Y/N)

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 NAME POSITION DATE SIGNATURE

REGISTER OF APPROVED SIGNATORIES

Source: GLI Stepwise Process towards TB Laboratory Accreditation

Lab Director/Date: ______________________________

Source: GLI Stepwise Process towards TB Laboratory Accreditation