Quality
Quality, in pathology, has got a lot of attention lately because there have been high profile screw-ups that lead to significant harm.[1]
Analysis
Overview
Quality issues are examined a number of different ways, e.g. root cause analysis, failure mode and effects analysis (FMEA).
A common way to break down error analysis is:
| Errors in pathology | |||||||||||||||||||||||||||||||||
| Pre-analytical errors | Analytical errors | Post-analytical errors | |||||||||||||||||||||||||||||||
Failure-potential analysis
Adapted from Ullman:[2]
- Identify potential individual failures.
- Identify the consequences of those failures.
- Identify how the individual failures can arise.
- Identify the corrective action.
Error analysis
- Pathology errors happen any time from when the lab gets the specimen until after the report is isssued.
When errors happen:
- Work-up problem - where did it occur.
- Talk to clinican - if it is a critical diagnosis contact most-responsible physician... if unreachable physician on-call for the most-responsible physician.
- Talk to chief of pathology.
- Incident report.
- Reconstruct error.
- Is there another error? (What it a specimen mix-up?)
- Amend report(s).
- Remedy source of error.
Pre-analytic:
- Container mix-up - pre-lab & in-lab.
- Block mix-up.
- Slide mix-up - labels wrong.
- Poor quality slides (fixation, processing, staining).
Analytic:
- Interpretation wrong.
- Difficult case.
- Technical factors (quality of slides).
Post-analytic:
- Wrong case signed-out.
- Filing problem.
- Interpretation of report problem (poorly written, bad interpretation).
Error reduction
Various strategies can be employed:[3]
- 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".
- Allow correlation with test.
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
A paper by Torlakovic et al.[4] divides immunohistochemistry (IHC) tests into:
- 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.
See also
References
- ↑ URL: http://www.attorneygeneral.jus.gov.on.ca/inquiries/goudge/index.html. Accessed on: 1 March 2011.
- ↑ Ullman, David G. (1997). The mechanical design process. Toronto: McGraw-Hill Companies Inc.. ISBN 0-07-065756-4.
- ↑ 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.
- ↑ 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.