726869990
Document type: SOP
Document code: TB 02-11
Confidentiality: none
1.
PURPOSE ............................................................................................................................... 2
2.
SCOPE .................................................................................................................................... 2
3.
RESPONSIBILITIES ............................................................................................................... 2
4.
CROSS REFERENCES .......................................................................................................... 2
5.
PROCEDURES ....................................................................................................................... 2
5.1 Entry of Results in database ............................................................................................................... 3
5.2 Review of results report ...................................................................................................................... 3
5.2.1 Report forms ................................................................................................................................ 3
5.3 Authorised Signatories ........................................................................................................................ 4
5.4 Reporting ............................................................................................................................................ 4
5.5 Copies and uncollected originals ........................................................................................................ 4
5.6 Results report dispatch ....................................................................................................................... 4
5.7 Guidelines for release of results directly to patients .......................................................................... 5
5.8 Procedures for immediate notification of MDR-TB ............................................................................ 5
5.8.1 Reporting Responsibility .............................................................................................................. 5
5.8.2 Reporting Procedure .................................................................................................................... 5
5.9 Turnaround Time ................................................................................................................................ 5
5.10 Reporting of urgent results ............................................................................................................... 6
5.11 Notification of delayed examination to requester............................................................................ 6
5.12 Release of results by or other electronic means............................................................................... 6
5.13 Verbal requests for results................................................................................................................ 7
5.14 Verification of transcribed results from referral laboratories .......................................................... 7
6. QUALITY CONTROL .............................................................................................................. 8
7. REFERENCES ........................................................................................................................ 8
8. CHANGE HISTORY ................................................................................................................ 8
This SOP template has been developed by FIND for adaption and use in TB laboratories
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1. PURPOSE
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.
2. SCOPE
This SOP covers all procedures pertaining to the reporting of results in the _________________TB
Laboratory.
3. RESPONSIBILITIES
This SOP applies to all laboratory technical staff, Quality Assurance, data clerks, supervisors and the
Head of the ___________________TB Laboratory:
Task
Documenting Test result on (Worksheets, Laboratory books) completely and accurately
Review of test results on worksheets and lab books
Ensure correct SOPs are followed while performing the tests and that test results are valid and properly documented.
Ensure reports are accurately filled out and free from transcription inaccuracies before final approval
Ensure that results are reported and sent to the appropriate people.
Final approval of results
Results tracking done as results are generated, in the laboratory to ensure timely reporting.
Right results are issued out to the right persons and signed up at collection and copies kept for future reference
Filling out of Corrective Action Log, in the event of assay failure.
4. CROSS REFERENCES
Responsible Accountable
Laboratory technical staff Supervisors
Authorized reviewers
Lab Manager
Data Admin
Data Admin
Lab Manager
Data Admin
Data Admin
Responsible tech
Lab Manager
Lab Director
Lab Manager
Lab Manager
Lab Director
Lab Manager
Lab Manager
Lab Manager
See: Document Matrix_TB 01-01_V1.0.doc
Corrective Action_form.doc
Occurrence Report_form.doc
Critical Result Reporting_form.doc
Location:
5. PROCEDURES
Approved Signatures_form.doc
Critical Result Log_form.doc

All procedure worksheets will be completed by the laboratory technical staff as required by the specific test standard operating procedures.
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
The laboratory technical staff will check the test results and test validity and sign on the worksheets.

The worksheets are then forwarded to the authorised reviewers, who specifically look for the detection of clerical, analytical errors and unusual laboratory results.

If the review process reveals a failed test run, a Corrective Action Form must be completed by the laboratory staff.

The reviewers approve test results and forward worksheets to the data clerks for entry.
5.1 Entry of Results in database

The data clerks or laboratory technical staff will enter results forwarded to them by the authorised reviewers.

The person entering the result must verify that the result has been entered correctly.

Data entered will consist of the following results:
 Microscopy
 Culture
 DST
 GeneXpert
 Genotype MTBDRplus

The data clerk will then print out preliminary results report.
5.2 Review of results report
The results report will be given to the reviewer and then the supervisor to validate accuracy of information on the report with raw data documents (worksheets). The reports are signed and dated as proof of data review.
5.2.1 Report forms
Each report form includes (where relevant):
Contents of a Laboratory Report

The test requested e.g. TB microscopy, culture and DST

Name of lab issuing the report. If done by a referral lab, the identity of the referral lab

Unique identification of the patient. At least 2 identifiers e.g. patient names, lab number, hospital number

Location of the patient e.g. TB ward, out patient
 Name or other unique identifier of the requester and the requester’s contact details e.g. name of clinician, or other authorized requester

Date of sample collection and time(when available and relevant to patient care);

Sample type e.g. sputum, fluid

Examination results reported in standard format understood by users

Reference ranges where applicable

Information required for interpreting results.

Comments e.g. quality or adequacy of sample which may have compromised the result e.g. salivary sputum

Identification of the person(s) who performed the tests, reviewed the results and person who authorized the release of the report. If any of these is not on the report, the information must be readily available when needed

Date and time of release of report.

Any other local requirements
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5.3 Authorised Signatories
A controlled copy of the list of Approved Signatures Form is held by the Quality Manager or the Head of the ___________________TB Laboratory. The Approved Signatures Form contains the names an signatures of reviewers, supervisors, and any other staff that have been approved to sign outgoing reports.
5.4 Reporting
 All result reports have to be approved and signed by two authorities; the technical reviewer and supervisor.
 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.
 The supervisor 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.
 The final report approval authority is the supervisor.
 In the event that the supervisor is not available, the laboratory delegated person will be authorised to complete the reporting process. It is prudent for each laboratory to identify more than one reviewer and/or supervisor to authorise reports.
5.5 Copies and uncollected originals
 For all result report forms a photo-copy must be made.
 The original will be sent to the physician/healthcare facility that requested the test while the photocopy must be kept at laboratory.
 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 chronological order.
 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 (see SOP Document Control).
See: Document Control_TB 02-11_V1.0.doc
Location:
5.6 Results report dispatch
 The data clerks and the data administrator are responsible for issuing out results to authorised personnel. The results for dispatch folder shall be managed by the data section.
 All results collected shall be photocopied and the original sent out while the copy is retained at laboratory.
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 The collected/issued results shall be signed for in the “results dispatch book” by the person picking up the results from laboratory.
 It is the responsibility of the Data Administrator to ensure that all results being issued are dully approved/signed and bear a laboratory stamp.
5.7 Guidelines for release of results directly to patients
Under normal circumstances the laboratory is not to release results directly to the patients except in situations where the patient has delivered the specimen and request form in person. If the need arises the case will be handled by a supervisor or the Head of the ________________TB Laboratory.
5.8 Procedures for immediate notification of MDR-TB
5.8.1 Reporting Responsibility
 The laboratory staff performing DST, GeneXpert and Genotype MTBDRplus are responsible for bringing critical results (i.e. MDR and XDR to the IMMEDIATE attention of their supervisor and/or the Head of the _________________TB Laboratory.
 It is the responsibility of the supervisor and/or the Head of the _________________TB Laboratory to review the data for the critical result and report to the appropriate person.
5.8.2 Reporting Procedure
 Critical results are those that pertain to the diagnosis of MDR-TB and XDR-TB.
 A contact list will be available in the beginning of the Critical Result Log Form which lists the person and phone number to call, depending on the health care facility.
 Once results have been verified and reviewed, the reporting person should call the designated person on the critical reporting list for that health care facility.
 Reporter should: o State that a critical result is being reported o ii. Give Patient Name and Patient ID of sample o iii. Give critical result (MDR or XDR) o iv. Get name of person critical result is reported to
 5. Receiver of critical result must: o Repeat back patient Name and Patient ID o Critical Result
6. Once phone call is complete, the reporter must complete the Critical Result Reporting Form.
5.9 Turnaround Time
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The _____________ laboratory endeavours to keep its turnaround time (TAT) for tests as short as possible. Turnaround times are, however, highly variable, depending on the type of test:
Method
Microscopy
LJ culture
MGIT culture
HAIN
LJ DST
MGIT DST
GeneXpert
Expected TAT
24 hours
9 weeks maximum
7 weeks maximum
3 days
7 weeks
14 days
24 hours
5.10 Reporting of urgent results
 The laboratory staff are responsible for bringing urgent results to the IMMEDIATE attention of their supervisor and/or the Head of the _________________TB Laboratory.
 It is the responsibility of the supervisor and/or the Head of the _________________TB Laboratory to review the data for the urgent result and report it to the appropriate person. . Once results have been verified and reviewed, the reporting person should call the requester of the urgent result.
 The reporter should: o State that an urgent result is being reported o ii. Give Patient Name and Patient ID of sample o iii. Give urgent result
 iv. Get name of person the urgent result is reported to
 Receiver of urgent result must: o Repeat back patient Name and Patient ID o ii. The urgent result
 Once phone call is complete, reporter must fill out the Critical Result Reporting Form.
5.11 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 Head of the ____________________TB Laboratory will notify the requester giving reasons for delay and the expected results date.
5.12 Release of results by or other electronic means
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It is not a policy of laboratory to report results using telephone except those classified as critical results to authorised personnel. In the event that this has occurred, the laboratory will follow up the verbal result with a properly recorded report even in cases of critical or urgent results.
If available, telephones will also be used to send Short Message Service (SMS) to requesting person in the peripheral laboratories. Microscopy, Culture, DST, GeneXpert and Genotype MTBDRplus results are sent out immediately they become available. A properly recorded report follows.
5.13 Verbal requests for results
Verbal requests for results by phone are common. Only results that are reviewed and deemed complete should be reported. If the reporter is unsure, they should consult a supervisor. For verbal result requests, the reporter should:
 Request the name and Patient ID
 Search the database or worksheets for the result.
 Reply to the requester with the following information:
 Give Patient Name and Patient ID of sample
 Give the result
 Receiver of the result must: o Repeat back Patient Name and Patient ID o Give the result
5.14 Verification of transcribed results from referral laboratories
Results received from referral laboratories need to verified before a report is generated:
 All test results and test validity are checked by the a supervisor.
 The supervisor verifies the following: o The Patient Name and Patient ID o The referral number from the laboratory and the referral number appearing on referral laboratory report are the same. o The results received are the for the test requested.
 The supervisor generates a report containing the referral results.
 The supervisor will review the comments on the reports to ensure that they are accurate.
 The final report approval authority is another supervisor and/or the Head of the
__________________TB Laboratory.
5.15 Release of results in the case of nonconformities
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 If it is discovered that an erroneous result has been sent out to the physician, the data section must notify the Head of the __________________TB laboratory or Quality Manager immediately.
 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".
 Attach a memo to the new report, explaining reasons for the corrected report and that date that the new report replaces.
 Document error on the Corrective Action Form. 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.
 Maintain the Corrective Action Form, a copy of the new and original report along with any correspondence(s) to the physician or health care facility that may arise.
 File in the revised reports file.
6. QUALITY CONTROL
6.1.1 Laboratory test results
 All test results and test validity are checked by test operator.
 Results are checked by authorised reviewers who specifically look for the detection of clerical, analytical and unusual laboratory results.
 The data reviewer verifies microscopy, culture, DST, GeneXpert and Genotype MTBDRplus results printed on report forms before forwarding to the supervisor for further approval.
8.
6.1.2 Report forms
All reports are checked for accuracy of data and patient ’s information before results are reported.
7. REFERENCES
 ISO 15189 Medical Laboratories – Particular requirements for quality and competence Quality
Manual.
CHANGE HISTORY
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