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Quality (view source)

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'''Quality''', in pathology, has got a lot of attention lately because there have been high profile screw-ups that lead to significant harm.<ref>URL: [http://www.attorneygeneral.jus.gov.on.ca/inquiries/goudge/index.html http://www.attorneygeneral.jus.gov.on.ca/inquiries/goudge/index.html]. Accessed on: 1 March 2011.</ref>
'''Quality''', in pathology, has got a lot of attention lately because there have been high-profile irregularities that lead to significant harm.<ref>URL: [http://www.attorneygeneral.jus.gov.on.ca/inquiries/goudge/index.html http://www.attorneygeneral.jus.gov.on.ca/inquiries/goudge/index.html]. Accessed on: 1 March 2011.</ref><ref>Judicial inquiry probes faulty breast cancer tests. CBC website. URL: [http://www.cbc.ca/news/background/cancer/inquiry.html http://www.cbc.ca/news/background/cancer/inquiry.html]. Accessed on: 30 January 2012.</ref>


==Analysis==
=General=
Quality issues are examined a number of different ways, e.g. root cause analysis, failure mode and effects analysis (FMEA).
The keys to ''quality'' are: 
#Understanding the needs of the stakeholders (surgeons, oncologists, patients, other pathologists, the public at large).
#Understanding the processes.
#Developing measures of quality.
#Tracking the measures of quality & assessing their validity.
#Understanding the causes of failures/adverse events in the context of the processes.
#Continually doing all of the above with the aim of improving outcomes - continuous quality improvement.


=Definitions=
==System documentation and description==
Quality Management Program-Laboratory Services (QMP-LS) defines a hierarchy of documentation:<ref name=qmpls_org>URL: [http://www.qmpls.org/LaboratoryAccreditation/OLAActivitiesEducationalTools/OLAPresentations/tabid/111/id/11/Default.aspx) http://www.qmpls.org/LaboratoryAccreditation/OLAActivitiesEducationalTools/OLAPresentations/tabid/111/id/11/Default.aspx)]. Accessed on: 18 April 2012.</ref>
*Policy.
*Process
*Procedures.
===Policy===
*High level document
*Describes rationale for processes, defines goals/objectives - includes parameters that can be measured.
===Process===
*Intermediate level document.
*Defines input and outputs, outlines the steps taken to achieve an objective - should ''not'' be overly detailed.
===Procedure===
*Low level document.
*Detailed line-by-line instructions - description of the workflow.
==Other==
===Quality control===
*Examines whether a process is hitting its target(s) for its measure(s) of quality.
In short: ''Does it hit the targets?''
===Quality assurance===
*Program to insure that a process is yielding the desired output(s).
In short: ''Does it produce the desired output?''
=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.
====The classic structural break down====
A classic structural break down for error analysis is:
{{familytree/start}}
{{familytree/start}}
{{familytree | | | | | | | | | A01 | | | | | |A01=Errors in pathology}}
{{familytree | | | | | | | | | A01 | | | | | |A01=Errors in pathology}}
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{{familytree | | | | B01 | | | B02 | | | B03|B01=Pre-analytical errors|B02=Analytical errors|B03=Post-analytical errors }}
{{familytree | | | | B01 | | | B02 | | | B03|B01=Pre-analytical errors|B02=Analytical errors|B03=Post-analytical errors }}
{{familytree/end}}
{{familytree/end}}
Note:
*This break down is arbitrary and ''in of itself'' most useful for answering exam questions.
*In a practical context, it is a frame work for classifying errors.  It is ''not'' useful for understanding the source of an error or addressing it.
====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).
==Sources of error==
*"Human error".
**Training.
**Work flow.
*Process gaps.
**Process control.
**Lack of redundancy.
==Types of errors==
Can be subdivided into the following groups:<ref>{{Cite journal  | last1 = Renshaw | first1 = AA. | title = Measuring and reporting errors in surgical pathology. Lessons from gynecologic cytology. | journal = Am J Clin Pathol | volume = 115 | issue = 3 | pages = 338-41 | month = Mar | year = 2001 | doi = 10.1309/M2XP-3YJA-V6E2-QD9P | PMID = 11242788 }}</ref>
*False-negative - missed diagnosis.
*False-positive - diagnosis made that on review considered not to be present.
*Threshold - difference of opinion regarding a diagnostic threshold.
*Type and grade.
*Missed margin.
*Other.
==Grading of errors==
May be subdivided by three groups:
*Grade 1: no consequence.
*Grade 2: possible consequence.
*Grade 3: definitely a consequence.


==Error reduction==
==Error reduction==
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*Training of staff - on error handling.
*Training of staff - on error handling.
*Computer order entry.
*Computer order entry.
**Avoid duplication.
**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.
*Barcode use.
**Avoid transcription errors.
**Avoid transcription errors.
*Clinical information entry required.
*Clinical information entry required.
**Allow correlation with testing.
**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".
*The use of algorithms to guide decisions where applicable.<ref>Kahneman D. ["Als wären wir gespalten": Der Psychologe und Nobelpreisträger Daniel Kahneman über die angeborenen Schwächen des Denkens, trügerische Erinnerungen und die irreführende Macht der Intuition]. Der Spiegel. Nr. 21. 2012. URL: [http://www.spiegel.de/spiegel/print/index-2012-21.html http://www.spiegel.de/spiegel/print/index-2012-21.html].</ref>
**Remove subjectivity.
**Increase objectivity, reproducibility.
 
==Dealing with diagnostic errors==
*Opinion is split on whether reports should be ''amended'' or ''addended'' - see ''[[sign out]]'' article.
 
=Measures of quality=
Any number of parameters can be used to measure quality. The when, where and how-often something is measured depends on the value-added.
 
===General measures of quality===
There are really only two:
#Timeliness, i.e. turn-around time (TAT).
#Error rate.
 
Note:
*1 and 2 can be examined/quantified in any number of ways.
*''Error'', in the context of a measurement, has to be defined.
 
===Internal measures of quality===
====Smaller categories====
Smaller categories - errors:<ref name=pmid19851132>{{Cite journal  | last1 = Nakhleh | first1 = RE. | title = Core components of a comprehensive quality assurance program in anatomic pathology. | journal = Adv Anat Pathol | volume = 16 | issue = 6 | pages = 418-23 | month = Nov | year = 2009 | doi = 10.1097/PAP.0b013e3181bb6bf7 | PMID = 19851132 }}</ref>
*Analytic: specimen identification & transport.
*Preanalytic/analytic: [[tissue processing]], e.g. [[fixation]], blocking, embedding, sectioning, staining.
*Analytic: interpretation.
*Postanalytic: reporting/report integrity.
 
=====Individual measures=====
Specific measures:<ref name=pmid19851132/>
*Preanalytic:
**Identification - numbers match requisition.
**Appropriate container.
*Analytic:
**Mislabeling.
**Interpretation errors - based on:
***Internal review.
****Cytology-histology correlation.
****Biopsy-resection correlation.
****Frozen section-permanent section correlation.
****Internal comparisons, e.g. ASCUS/LSIL between pathologists.
***External review.
****External standards/expected rate.
**Amended reports - captures several of the above.
*Postanalytic:
**Completeness of report.
**Critical diagnosis timely?
**Report delivered to appropriate person?
 
===External measures of quality===
====Benchmark====
*An external quality measure, i.e. a comparison to an outside group or agency.
**Slides are sent around from an external source:
***Lab has to stain 'em and send 'em back for an assessment.
***Pathologists render diagnoses on 'em and are given the (externally rendered) consensus diagnosis.
 
=Immunohistochemistry=
{{Main|Immunohistochemistry}}
 
===Classification of IHC tests===
IHC tests are classified in a paper by Torlakovic ''et al.'':<ref name=pmid20154273>{{Cite journal  | last1 = Torlakovic | first1 = EE. | last2 = Riddell | first2 = R. | last3 = Banerjee | first3 = D. | last4 = El-Zimaity | first4 = H. | last5 = Pilavdzic | first5 = D. | last6 = Dawe | first6 = P. | last7 = Magliocco | first7 = A. | last8 = Barnes | first8 = P. | last9 = Berendt | first9 = R. | title = Canadian Association of Pathologists-Association canadienne des pathologistes National Standards Committee/Immunohistochemistry: best practice recommendations for standardization of immunohistochemistry tests. | journal = Am J Clin Pathol | volume = 133 | issue = 3 | pages = 354-65 | month = Mar | year = 2010 | doi = 10.1309/AJCPDYZ1XMF4HJWK | PMID = 20154273 }}</ref>
*''Class I'':
**Results used by pathologists.
**Adjunct to histomorphology.
**Examples: CD45, S-100.
*''Class II'':
**Used by clinicans for treatment decisions.
**Considered independent of the other information in the pathology report; thus, cannot be derived from other information in the report.
**Examples: ER, PR, HER2, Ki-67, CD117, CD20.
 
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.
 
===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.


Other strategies:
IHC process:
*Statistical process control.
#Ischemia time - warm ischemia, preparation of specimen.
#Fixation - under, over, defective fixative, not enough fixative.
#Processing prior to antibody binding, usu. heating (antigen retrieval).
#Antibody-antigen binding.
#Reporter molecule binding.
#Counterstaining.
#Interpretation problem.
#*Known/expected epitope cross-reactions, e.g. [[CMV]] & [[HSV]].<ref name=pmid3029407>{{Cite journal  | last1 = Balachandran | first1 = N. | last2 = Oba | first2 = DE. | last3 = Hutt-Fletcher | first3 = LM. | title = Antigenic cross-reactions among herpes simplex virus types 1 and 2, Epstein-Barr virus, and cytomegalovirus. | journal = J Virol | volume = 61 | issue = 4 | pages = 1125-35 | month = Apr | year = 1987 | doi =  | PMID = 3029407 | PMC = 254073 |
URL = http://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073/?tool=pubmed }}</ref>
#*Unknown/unexpected epitope cross-reactions.


==Sources of error==
Notes:
*"Human error".
*Problems can arise at any step.
**Training.
 
**Work flow.
=Other=
*Process gaps.
==Data retention standards==
**Process control.
*There are data retention standards - how long results have to be retained.
**Lack of redundancy.
 
===College of American Pathologists===
*In the United States, there are standards from ''College of American Pathologists'' (CAP) and ''Clinical Laboratory Improvement Amendments'' (CLIA).<ref>URL: [http://www.cms.gov/clia/ http://www.cms.gov/clia/]. Accessed on: 1 April 2012.</ref>
 
Selected CAP and CLIA standards:<ref>URL: [http://home.ccr.cancer.gov/lop/intranet/policymanual/generalpolicy/CAPCLIA.asp http://home.ccr.cancer.gov/lop/intranet/policymanual/generalpolicy/CAPCLIA.asp]. Accessed on: 1 April 2012.</ref>
*Cytology slide (non-fine needle aspiration): 5 years from the exam date.
*Fine needle aspiration: 10 years from the exam date.
*Histopathology slides: 10 years from the exam date.
 
===Canadian Association of Pathologists===
The Canadian standards are higher than the US ones.
 
Summary of selected suggestions:<ref>URL: [http://cap-acp.org/guide_retention-human-biologic-material.cfm http://cap-acp.org/guide_retention-human-biologic-material.cfm]. Accessed on: 6 May 2012.</ref>
{| class = "wikitable sortable"
! Material
! Origin
! Suggested retention period
! Additional notes
|-
| Wet tissue
| surgical
| 4 weeks after final report
| -
|-
| Paraffin blocks
| surgical
| 20 years
| 50 years for paediatric cases
|-
| Slides
| surgical
| 20 years
| -
|-
| Wet tissue
| autopsy
| 3 months after final report
| Coroners'/medical examiner cases may be longer
|-
| Paraffin blocks
| autopsy
| 10 years
| Coroners'/medical examiner cases may be longer
|-
| Slides
| autopsy
| 10 years
| Coroners'/medical examiner cases may be longer
|-
|}
 
==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.


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


==See also==
=Quality standards organization=
There are a large number of organizations that have written standards for quality in laboratory medicine.
 
==International==
===International standards organization===
*Abbreviated ''ISO''.
 
Standard:
*ISO 15189:2007.<ref>URL: [http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=42641 http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=42641]. Accessed on: 18 April 2012</ref>.
**Published in 2007. Supersedes a standard published in 2003.
 
Note:
*Unfortunately one has to shell out money to get a peak at 'em.
 
==United States of America==
===Clinical laboratory improvement amendments===
*Abbreviated ''CLIA''.
*Published a multitude of standards & guidelines.<ref>URL: [http://www.cms.hhs.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/ http://www.cms.hhs.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/]. Accessed on: 18 April 2012.</ref>
 
===College of American Pathologists===
*Do laboratory accreditation.<ref>URL: [http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=laboratory_accreditation%2Faboutlap.html&_state=maximized&_pageLabel=cntvwr http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=laboratory_accreditation%2Faboutlap.html&_state=maximized&_pageLabel=cntvwr]. Accessed on: 18 April 2012.</ref>
 
==Canada==
===Canadian immunohistochemistry quality control===
*Abbreviated ''CIQC''.
*[https://ciqc.ca/Pages/default.aspx CIQC webpage (ciqc.ca)]
 
===Ontario===
*[[Institute for Quality Management in Healthcare]] - previously ''Quality Management Program - Laboratory Services''.
**Set-up by the ''Ontario Medical Assocation''.
 
==United Kingdom==
*National Pathology Benchmarking Service (NPBS).<ref>URL: [http://www.keele.ac.uk/pharmacy/general/npbs/ http://www.keele.ac.uk/pharmacy/general/npbs/]. Accessed on: 18 April 2012.</ref>
 
=See also=
*[[Critical values]].
*[[Critical values]].
*[[CAP checklists]].
*[[Tissue floater]].
*[[Histology artifacts]].
*[[Waffle diagnosis]].
*[[Workload measurement]].
*[[Anatomical pathology laboratory processes]].
=References=
{{Reflist|2}}


==References==
=External links=
{{Reflist|1}}
*[http://www.keele.ac.uk/pharmacy/general/npbs/ UK national benchmarking (keele.ac.uk)].
*[http://www.westgard.com/westgard-rules-and-multirules.htm Multirule quality control - (westgard.com)] - statistical process control explained for the mathematically challenged.


[[Category:Quality]]
[[Category:Quality]]
Michael
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