Difference between revisions of "Quality"

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==Analysis==
==Analysis==
===Overview===
===Overview===
Quality issues are examined a number of different ways, e.g. root cause analysis, failure mode and effects analysis (FMEA).
Quality issues can be examined in a number of different ways.


A common way to break down error analysis is:  
Finding a problem:
{{familytree/start}}
*Root cause analysis.
{{familytree | | | | | | | | | A01 | | | | | |A01=Errors in pathology}}
{{familytree | | | | |,|-|-|-|-|+|-|-|-|-|.| |}}
{{familytree | | | | B01 | | | B02 | | | B03|B01=Pre-analytical errors|B02=Analytical errors|B03=Post-analytical errors }}
{{familytree/end}}


====Failure-potential analysis====
Anticipating problems:
Adapted from Ullman:<ref name=ullman>{{cite book |title=The mechanical design process |last= Ullman |first = David G. |authorlink= |coauthors= |year= 1997 |publisher= McGraw-Hill Companies Inc. |location= Toronto|isbn=0-07-065756-4 |page= |pages= |url= |accessdate=}}</ref>
*Failure mode and effects analysis (FMEA).
#Identify potential individual failures.
#Identify the consequences of those failures.
#Identify how the individual failures can arise.
#Identify the corrective action.


===General error analysis===
===General error analysis===
*Pathology errors happen any time from when the lab gets the specimen until after the report is issued.
Pathology errors happen any time from when the lab gets the specimen until after the report is issued.


When errors happen:
When errors happen:
*Work-up the problem.
*Work-up the problem.
**Where did the error occur?
**Where did the error occur? Pathologist error?
*Talk to the clinician.
*Talk to the clinician.
**If it is a ''[[critical diagnosis]]'' contact the most-responsible physician immediately... if they are unreachable call the physician on-call for the most-responsible physician... if the patient is out-of-town you may have to coordinate with the local emergency department.   
**If it is a ''[[critical diagnosis]]'' contact the most-responsible physician immediately... if they are unreachable call the physician on-call for the most-responsible physician... if the patient is out-of-town you may have to coordinate with the local emergency department.   
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*Amend the report(s).
*Amend the report(s).
*Remedy the source of error.
*Remedy the source of error.
A common way to break down error analysis is:
{{familytree/start}}
{{familytree | | | | | | | | | A01 | | | | | |A01=Errors in pathology}}
{{familytree | | | | |,|-|-|-|-|+|-|-|-|-|.| |}}
{{familytree | | | | B01 | | | B02 | | | B03|B01=Pre-analytical errors|B02=Analytical errors|B03=Post-analytical errors }}
{{familytree/end}}


====Pre-analytic errors====
====Pre-analytic errors====
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The implication of irregularies in the different classes are different. Problems in ''Class II'' tests are potentially more severe, as there is no internal control.
The implication of irregularies in the different classes are different. Problems in ''Class II'' tests are potentially more severe, as there is no internal control.
==Other==
===Failure-potential analysis===
Adapted from Ullman:<ref name=ullman>{{cite book |title=The mechanical design process |last= Ullman |first = David G. |authorlink= |coauthors= |year= 1997 |publisher= McGraw-Hill Companies Inc. |location= Toronto|isbn=0-07-065756-4 |page= |pages= |url= |accessdate=}}</ref>
#Identify potential individual failures.
#Identify the consequences of those failures.
#Identify how the individual failures can arise.
#Identify the corrective action.


==See also==
==See also==

Revision as of 15:32, 22 January 2012

Quality, in pathology, has got a lot of attention lately because there have been high profile screw-ups that lead to significant harm.[1]

General

The keys to quality are understanding the:

  1. Needs of the stakeholders (surgeons, oncologists, patients, other pathologists, the public at large).
  2. Processes.
  3. Developing measures of quality.
  4. Tracking the measures of quality.
  5. Understanding the causes of failures/adverse events in the context of the processes.

Analysis

Overview

Quality issues can be examined in a number of different ways.

Finding a problem:

  • Root cause analysis.

Anticipating problems:

  • Failure mode and effects analysis (FMEA).

General error analysis

Pathology errors happen any time from when the lab gets the specimen until after the report is issued.

When errors happen:

  • Work-up the problem.
    • Where did the error occur? Pathologist error?
  • Talk to the clinician.
    • If it is a critical diagnosis contact the most-responsible physician immediately... if they are unreachable call the physician on-call for the most-responsible physician... if the patient is out-of-town you may have to coordinate with the local emergency department.
  • Talk to the chief of pathology.
  • Incident report.
  • Reconstruct error.
    • Was it a specimen mix-up?
      • Is there another error?
  • Amend the report(s).
  • Remedy the source of error.

A common way to break down error analysis is:

 
 
 
 
 
 
 
 
Errors in pathology
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pre-analytical errors
 
 
Analytical errors
 
 
Post-analytical errors

Pre-analytic errors

  • Container mix-up - pre-lab & in-lab.
  • Block mix-up.
  • Slide mix-up - labels wrong.
  • Poor quality slides (fixation, processing, staining).
  • Lost specimen - can be potentially anywhere in the process.

Analytic errors

  • Interpretation wrong.
    • Factors:
      • Difficult case.
      • Technical factors (quality of slides).
      • Lack of clinical history.

Post-analytic errors

  • Wrong case signed-out.
  • Filing problem/lost report.
  • Interpretation of report problem (poorly written report, misinterpretation).

Error reduction

Various strategies can be employed:[2]

  • Training of staff - on error handling.
  • Computer order entry.
    • Avoid duplication fatigue.
    • Quick correlation with several identifying features.
      • Full name, sex, date of birth -- these all appear when one opens a case.
  • Barcode use.
    • Avoid transcription errors.
  • Clinical information entry required.
    • Allow correlation with test.
      • The interpretation may differ if the history says "screening coloscopy" versus "large cecal mass, anemia and weight loss" versus "breast cancer".

Other strategies:

  • Statistical process control.

Sources of error

  • "Human error".
    • Training.
    • Work flow.
  • Process gaps.
    • Process control.
    • Lack of redundancy.

Biopsy size

Very small tissue fragments are associated with a decreased diagnostic yield and an increased diagnostic uncertainty.

Immunohistochemistry

Main article: Immunohistochemistry

Work-up of suspected IHC problems:

  • Review controls (internal and external).
    • Isolated to case vs. larger problem?
      • Discuss with lab/make other pathologists aware of the issue.
  • Repeat test - to identify the cause.

IHC process:

  1. Ischemia time - warm ischemia, preparation of specimen.
  2. Fixation - under, over, defective fixative, not enough fixative.
  3. Processing prior to antibody binding, usu. heating (antigen retrieval).
  4. Antibody-antigen binding.
  5. Reporter molecule binding.
  6. Counterstaining.
  7. Interpretation problem.
    • Epitope cross-reactions - expected (e.g. CMV & HSV)[3], unexpected/unknown.

Notes:

  • Problems can arise at any step.

Classification of IHC tests

IHC tests are classified in a paper by Torlakovic et al.:[4]

  • Class I:
    • Adjunct to histomorphology.
    • Examples: CD45, S-100.
  • Class II:
    • Considered independent of the other information in the pathology report; thus, cannot be derived from other information in the report.
    • Used directly for treatment decisions.
    • Examples: ER, PR, HER2.

The implication of irregularies in the different classes are different. Problems in Class II tests are potentially more severe, as there is no internal control.

Other

Failure-potential analysis

Adapted from Ullman:[5]

  1. Identify potential individual failures.
  2. Identify the consequences of those failures.
  3. Identify how the individual failures can arise.
  4. Identify the corrective action.

See also

References

  1. ↑ URL: http://www.attorneygeneral.jus.gov.on.ca/inquiries/goudge/index.html. Accessed on: 1 March 2011.
  2. ↑ Fabbretti, G. (Jun 2010). "Risk management: correct patient and specimen identification in a surgical pathology laboratory. The experience of Infermi Hospital, Rimini, Italy.". Pathologica 102 (3): 96-101. PMID 21171512.
  3. ↑ Balachandran, N.; Oba, DE.; Hutt-Fletcher, LM. (Apr 1987). [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073 URL = http://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073/?tool=pubmed/ "Antigenic cross-reactions among herpes simplex virus types 1 and 2, Epstein-Barr virus, and cytomegalovirus."]. J Virol 61 (4): 1125-35. PMC [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073 URL = http://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073/?tool=pubmed 254073 URL = http://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073/?tool=pubmed]. PMID 3029407. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073 URL = http://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073/?tool=pubmed/.
  4. ↑ Torlakovic, EE.; Riddell, R.; Banerjee, D.; El-Zimaity, H.; Pilavdzic, D.; Dawe, P.; Magliocco, A.; Barnes, P. et al. (Mar 2010). "Canadian Association of Pathologists-Association canadienne des pathologistes National Standards Committee/Immunohistochemistry: best practice recommendations for standardization of immunohistochemistry tests.". Am J Clin Pathol 133 (3): 354-65. doi:10.1309/AJCPDYZ1XMF4HJWK. PMID 20154273.
  5. ↑ Ullman, David G. (1997). The mechanical design process. Toronto: McGraw-Hill Companies Inc.. ISBN 0-07-065756-4.
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