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RESULTS REPORTING
Confidentiality: none
Table of Contents
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............................................................................................... 6
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.............................................7
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.............................................................................................................. 9
This SOP template has been developed by FIND for adaption and use in TB laboratories
Release date: ddMMMyy
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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 laboratorys 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.
Responsible
Laboratory technical staff
Accountable
Supervisors
Authorized reviewers
Lab Manager
Lab Manager
Lab Director
Data Admin
Lab Manager
Data Admin
Lab Manager
Data Admin
Lab Manager
Lab Director
Lab Manager
Data Admin
Lab Manager
Responsible tech
Lab Manager
4. CROSS REFERENCES
See:
Location:
5. PROCEDURES
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.
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.
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
Name or other unique identifier of the requester and the requesters contact details e.g. name of clinician, or other authorized
requester
Date of sample collection and time(when available and relevant to patient care);
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
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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.
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.
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:
Location:
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.
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.
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
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
The laboratory staff are responsible for bringing urgent results to the IMMEDIATE attention of
their supervisor and/or the Head of the _________________TB Laboratory.
Once phone call is complete, reporter must fill out the Critical Result Reporting Form.
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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:
All test results and test validity are checked by the a supervisor.
The referral number from the laboratory and the referral number appearing on referral
laboratory report are the same.
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.
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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.
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.
7. REFERENCES
ISO 15189 Medical Laboratories Particular requirements for quality and competence Quality
Manual.
8.
CHANGE HISTORY
New version #
Old version
No. of
Description of changes
Source of
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/ date
# / date
changes
change request
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