Institution
Laboratory name
Location
Head/Responsible person / Standard Operating Procedure (SOP)
Reporting of test results / Code:
Version: no.
Date: of release
Page: 1of 8

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

•QMQuality Manual

•SOP Standard Operating Procedure

•QAQuality Assurance Unit

•DSTDrug Susceptibility Testing

•LJ Lowenstein-Jensen

•MGITMycobacteria Growth Indicator Tube

•AFBAcid-Fast Bacilli

4. Tasks, responsibilities and accountabilities

Task / Responsible / Accountable
Documenting Test result on (Worksheets, Laboratory books) completely and accurately / Lab techs / Lab Manager
Review of test results on worksheets and lab books / Authorized reviewers / Lab Manager
Ensure correct SOPs are followed while performing the tests and that test results are valid and properly documented. / Lab Manager / Lab Director
Ensure reports are accurately filled out and free from transcription inaccuracies before final approval / Data Admin / Lab Manager
Ensure that results are reported and sent to the appropriate people. / Data Admin / Lab Manager
Final approval of results / Lab Manager / Lab Director
Results tracking done as results are generated, in the laboratory to ensure timely reporting. / Data Admin / Lab Manager
Right results are issued out to the right persons and signed up at collection and copies kept for future reference / Data Admin / Lab Manager
Filling out of Corrective Action Log, in the event of assay failure. / Responsible tech / Lab Manager

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.
  4. Microscopy
  5. Culture
  6. DST
  7. The data clerk will then print out preliminary results report
  8. With AFB microscopy and/or positive cultures pending DSTfor (all studies except for TSRS)
  9. TC with AFB smear positive and HAIN results.
  10. 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.

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 personwill 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.
  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 alaboratory 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 patientsexcept 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
  2. All test results and test validity are checked by test operator.
  3. Results are checked by authorized reviewers who specifically look for the detection of clerical, analytical and unusual laboratory results.
  4. The data reviewer verifies microscopy, culture and DST results printed on report forms before forwarding to laboratory manager for further approval.
  1. Report forms
  2. 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

  1. Reporting Responsibility
  2. 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).
  3. It is the responsibility of the Shipping coordinator to review the data for the critical value and report to the appropriate person.
  4. If the Shipping coordinator is not available, the critical value should be reported to the lab manager.
  1. Reporting Procedure
  2. Critical values are MDR and XDR.
  3. 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.
  4. Once results have been verified and reviewed, the reporting person should call the first person on the critical reporting list for the appropriate study.
  5. Reporter should:
  6. State that a critical value is being reported
  7. Give Patient Name and Patient ID of sample
  8. Give critical value (MDR or XDR)
  9. Get name of person critical value is reported to
  10. Receiver of critical value must:
  11. Repeat back patient Name and ID
  12. Critical Value
  13. 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 laboratory endeavours to keep its turnaround time for tests as short as possible. Turnaround times are, however, highly variable, depending on the type of test.

Method / Expected TAT
Microscopy / 2 working days
LJ culture / 9 weeks maximum
MGIT culture / 7 weeks maximum
HAIN / 3 days
LJ DST / 7 weeks
MGIT DST / 14 days

6.8Notification 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.

6.9Results 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

  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 reportand that date that the new report replaces.
  4. Document error in corrective action log (CA log; see SOP Corrective Action). The record must show thetime, 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 ofthe 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 LaboratoryAccreditation

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

Critical Value Reporting Log

Source: GLI Stepwise Process towards TB LaboratoryAccreditation

NAME / POSITION / DATE / SIGNATURE

REGISTER OF APPROVED SIGNATORIES

Lab Director/Date: ______

Source: GLI Stepwise Process towards TB LaboratoryAccreditation