Difference between revisions of "Quality"

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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><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>
'''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>


=General=
=General=
The keys to ''quality'' are:   
The keys to ''quality'' are:   
#Understanding the beeds of the stakeholders (surgeons, oncologists, patients, other pathologists, the public at large).
#Understanding the needs of the stakeholders (surgeons, oncologists, patients, other pathologists, the public at large).
#Understanding the processes.
#Understanding the processes.
#Developing measures of quality.
#Developing measures of quality.
#Tracking the measures of quality & assessing their validity.
#Tracking the measures of quality & assessing their validity.
#Understanding the causes of failures/adverse events in the context of the processes.
#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.
#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=
=Analysis=
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*Grade 1: no consequence.
*Grade 1: no consequence.
*Grade 2: possible consequence.
*Grade 2: possible consequence.
*Grade 3: definitely a consequency.
*Grade 3: definitely a consequence.


==Error reduction==
==Error reduction==
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**Allow correlation with test.
**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 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.


Other strategies:
==Dealing with diagnostic errors==
*Statistical process control.
*Opinion is split on whether reports should be ''amended'' or ''addended'' - see ''[[sign out]]'' article.


=Measures of quality=
=Measures of quality=
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*''Error'', in the context of a measurement, has to be defined.
*''Error'', in the context of a measurement, has to be defined.


===Internal measures of quality===
====Smaller categories====
====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>
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>
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**Report delivered to appropriate person?
**Report delivered to appropriate person?


===Type of quality measures===
===External measures of quality===
====Benchmarking====
====Benchmark====
*An external quality standard.
*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=
=Immunohistochemistry=
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#Counterstaining.
#Counterstaining.
#Interpretation problem.
#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 |
#*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>  
URL = http://www.ncbi.nlm.nih.gov/pmc/articles/PMC254073/?tool=pubmed }}</ref>  
#*Unknown/unexpected epitope cross-reactions.
#*Unknown/unexpected epitope cross-reactions.
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=Other=
=Other=
==Data retention standards==
*There are data retention standards - how long results have to be retained.
===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==
==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>
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>
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==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.
=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=
=See also=
*[[Critical values]].
*[[Critical values]].
*[[CAP checklists]].
*[[CAP checklists]].
*[[Tissue floater]].
*[[Histology artifacts]].
*[[Waffle diagnosis]].
*[[Workload measurement]].
*[[Anatomical pathology laboratory processes]].


=References=
=References=
{{Reflist|2}}
{{Reflist|2}}
=External links=
*[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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