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Reply 4 Assessment Assignment

1. The document contains the answers to 5 questions about quality management in a clinical laboratory. 2. For question 1, the respondent lists 10 steps for conducting an internal lab audit, including selecting auditors, defining the audit scope and activities, and implementing corrective actions. 3. For question 2, the respondent provides a checklist for auditing the pre-examination process, including policies and procedures for sample handling, storage, and acceptance criteria. 4. For question 5, the respondent lists 10 possible reasons for repeated poor performance on Gram stains in EQA, such as staff training issues, nonconformance to SOPs, and lack of quality control systems.

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128 views

Reply 4 Assessment Assignment

1. The document contains the answers to 5 questions about quality management in a clinical laboratory. 2. For question 1, the respondent lists 10 steps for conducting an internal lab audit, including selecting auditors, defining the audit scope and activities, and implementing corrective actions. 3. For question 2, the respondent provides a checklist for auditing the pre-examination process, including policies and procedures for sample handling, storage, and acceptance criteria. 4. For question 5, the respondent lists 10 possible reasons for repeated poor performance on Gram stains in EQA, such as staff training issues, nonconformance to SOPs, and lack of quality control systems.

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DAWOOD
Copyright
© © All Rights Reserved
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Download as DOCX, PDF, TXT or read online on Scribd
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Reply 4….

Assessment, Assignment 4

Q1. You are the quality manager in your laboratory, and you want to organize an
internal audit. What steps will you take?

Ans:

Following steps will be considered for performing Internal Lab Audits

1. Objective of the Audit. ...


2. Schedule for the Audit. ...
3. Auditors(s) selection for audit
4. Scope of audit
5. Preparation for the Audit. ...
6. Utilize a Patient Tracer. ...
7. Conduct of the Audit /Activities to Be Audited ...Pre analytical and Analytical
8. Preparation of an Audit Report/NC report ...
9. Implementation of Corrective Actions. ...
10. Evaluation of the Effectiveness of the Audit.

Q2. Create a checklist for conducting internal audits for the pre-examination
process.
Ans:
Checklist for conducting internal audits for the pre-examination process:

Preanalytical Review of:


• Temperature logs
• Sample receipt logs
• Sample rejection logs
• Sample quality logs
Policies and procedures for:
• Sample or patient identification verification
• Sample collection, handling, and transportation
• Sample receipt, preparation, and storage
• Sample acceptance and rejection criteria
• Chain of custody
• Data entry and review
Q3. List three measurable examples of quality indicators for each pre-
examination, examination and post-examination processes for your laboratory.

Ans:

Important quality indicators

Q4. List key EQA programs that you think your laboratory is missing and should
participate in.
Ans:
Following EQA program are available…
1. NEQAAP Pakistan
2. UK NEQAS
3. Biorad
4. Randox
5. EQALM
6. CAP
There are many tests for which EQA is needed
1. Immunophenotyping of Myelo and lymphoproliferative disorders
2. Tissue cross match for renal transplant
3. HLA typing by molecular methods
4. Serum FLCs

Q5. You are a newly appointed laboratory supervisor, while reviewing past EQA
results you notice poor Gram stain performance has occurred several times. How
would you investigate this problem? Write down your ideas.

Ans:
Possible reasons of repeated poor Gram staining:

1. Repeated changing of technician


2. Untrained staff
3. Nonconformance to SOP
4. Compromised reagent quality
5. Lack of supervision
6. No system of quality verification
7. Internal quality control system not being implemented
8. NCs not being raised in case of error
9. No system of Lab managers awareness regarding repeated poor quality
10. Lack of Quality indicators

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