48,453
edits
(25 intermediate revisions by the same user not shown) | |||
Line 1: | Line 1: | ||
'''Quality''', in pathology, has got a lot of attention lately because there have been high profile | '''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 | #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= | ||
Line 88: | Line 117: | ||
*Grade 1: no consequence. | *Grade 1: no consequence. | ||
*Grade 2: possible consequence. | *Grade 2: possible consequence. | ||
*Grade 3: definitely a | *Grade 3: definitely a consequence. | ||
==Error reduction== | ==Error reduction== | ||
Line 103: | Line 132: | ||
**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. | |||
==Dealing with diagnostic errors== | |||
* | *Opinion is split on whether reports should be ''amended'' or ''addended'' - see ''[[sign out]]'' article. | ||
=Measures of quality= | =Measures of quality= | ||
Line 119: | Line 151: | ||
*''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> | ||
Line 147: | Line 180: | ||
**Report delivered to appropriate person? | **Report delivered to appropriate person? | ||
=== | ===External measures of quality=== | ||
====Benchmark==== | ====Benchmark==== | ||
*An external quality measure, i.e. a comparison to an outside group or agency. | *An external quality measure, i.e. a comparison to an outside group or agency. | ||
Line 184: | Line 217: | ||
#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. | ||
Line 192: | Line 225: | ||
=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> | ||
Line 201: | Line 287: | ||
==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= | ||
Line 211: | Line 336: | ||
=External links= | =External links= | ||
*[http://www.keele.ac.uk/pharmacy/general/npbs/ UK national benchmarking (keele.ac.uk)]. | *[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]] |
edits