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Module 19 - Process MGT - Results Management

This module outlines the Quality Management System (QMS) requirements for handling laboratory results, including report attributes, content, review processes, and release protocols. It emphasizes the importance of accuracy, completeness, and confidentiality in reporting results, as well as the procedures for revising reports and using automated systems. Key messages highlight the necessity for authorized personnel to manage results and maintain a standardized reporting format to meet customer needs.

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Seifudin Usman
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8 views18 pages

Module 19 - Process MGT - Results Management

This module outlines the Quality Management System (QMS) requirements for handling laboratory results, including report attributes, content, review processes, and release protocols. It emphasizes the importance of accuracy, completeness, and confidentiality in reporting results, as well as the procedures for revising reports and using automated systems. Key messages highlight the necessity for authorized personnel to manage results and maintain a standardized reporting format to meet customer needs.

Uploaded by

Seifudin Usman
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Module 19

Process Management:
Results Management

Africa Centres for Disease Control and Prevention (Africa CDC)

Laboratory Quality Management Systems


One Health Approach
Learning Objectives
At the end of this module, participants will be able to
understand QMS requirements for handling results
including:
• Report attributes
• Report content
• Review of results process
• Release of results
• Automated selection and reporting of results where
applicable.
• How to revise reports
Module 19: Process Management_Results Management
The Quality Management System

Organization Personnel Equipment

Purchasing & Process Information


Inventory Management Management

Documents & Nonconforming


Assessments
Records Event
Management

Continual Customer Facilities &


Improvement Focus Safety

Module 19: Process Management_Results Management


Review of Results
• Authorised personnel must review the results of
examinations before release.
• Results should be evaluated against internal quality
control and available clinical information
• Check for completeness and timeliness
• Report should be concise, accurate, without any
ambiguity

Module 19: Process Management_Results Management


Reporting of Results
• Document a procedure to ensure the correctness of
transcription of laboratory results
• Reports must include the information necessary for the
interpretation of the examination results
• Notify the requester when an examination is delayed
that could compromise patient care
• There should be evidence that the communication on
delayed results reached the intended recipient
Module 19: Process Management_Results Management
Identification
Interpretative Report of
comments attributes Critical results

Error-free and
Comments on
complete
sample integrity

Module 19: Process Management_Results Management


Report Contents
• Title of report
• Identity of the laboratory that issued the report
• Patient identification and patient location on each page
• Identification of all tests performed the lab
• Identification of tests performed by a referral lab
• Name and contacts of the test requester / customer
• Date (and time, where applicable) of sample collection
• Date sample received
• Type of primary sample

Module 19: Process Management_Results Management


Report contents
• Measurement procedure, where appropriate
• Additions to deviations and exclusions from the method
• Test results, in SI units
• Biological reference intervals
• Clinical decision values
• Interpretation of results, where appropriate

Module 19: Process Management_Results Management


Report Contents
• Identification of the person(s) reviewing and authorising the
release of the report
• Date of the report and time of release
• Page number to the total number of pages
• Tests done as part of a research or developmental program
• Statement of conformity, as needed

Module 19: Process Management_Results Management


Specific test report requirements
• Information on specific test conditions, e.g.,
environment
• Statement of conformity with requirements or
specifications
• Measurement of uncertainty
• Opinions and interpretations
• Additional information as required by stakeholders

Module 19: Process Management_Results Management


Release of Results
The laboratory should have a procedure for:
• Who may release results and to whom
• Addresses compromised or unsuitable samples received
• What happens when results fall into alert/Critical category
o A physician is notified

o Records are maintained

• Recall of erroneous results

Module 19: Process Management_Results Management


Release of Results
• Results must be legible without mistakes
• Released to persons authorised to receive them.
• When interim reports are sent, the final report is always
forwarded to the requester.
• Addresses results sent by phone.

Module 19: Process Management_Results Management


Automated selection and reporting of results
• Only applicable to electronic lab information systems.
• If implemented:
o Procedure should be documented including criteria

for automated selection and reporting


o Criteria must be approved, readily available and

understood by all relevant staff;


o the criteria are validated for proper functioning

before use or after system updates.


Module 19: Process Management_Results Management
Automated selection and reporting of results
• There must be a process for indicating the presence of
sample interferences (e.g. hemolysis, icterus, lipaemia)
that may alter the results of the examination.
• There is a process for incorporating analytical warning
messages from the instruments into the automated
selection and reporting criteria, when appropriate.

Module 19: Process Management_Results Management


Revised reports
When the original report is revised, there should be written
instructions regarding the revision so that:
• Reason for amendments must be stated
• The revised report is clearly identified as a revision and includes
reference to the date and patient’s identity in the original report
• The user is made aware of the revision
• The revised version shows the date and time of the change, and
the identity of the person who revised the report.
• The original report entries remain in the record when revisions
are made
Module 19: Process Management_Results Management
Summary

• Review of results must consider IQC and clinical history


when available.
• Results must be complete, accurate, without ambiguity.
• Result report format should be standardised and meet
customer needs.
• Where automated selection and reporting is used, there
must be a procedure defining what is automatically sent
to clinicians.
• Revised reports must be traceable and reference to the
original report.
Module 19: Process Management_Results Management
Key messages
• Examination results are the key product of the laboratory.
• Only authorised personnel should release and amend results if
needed.
• Maintain strict confidentiality when handling results.

Module 19: Process Management_Results Management


Thank you

Module 19: Process Management_Results Management

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