Difference between revisions of "User:Shawndouglas/Sandbox"

From LIMSWiki
Jump to navigationJump to search
Line 14: Line 14:




* automated reflex testing: Some PIMS vendors include pre-loaded, customizable lists of reflex tests associated with certain pathology procedures and their associated diagnoses. Optimally, these reflex texts are automatically suggested at specimen reception, based on specimen and/or pathology test type.<ref name="NovoPathSoftware13">{{cite web |url=https://www.novopath.com/content/pdf/novopathbrochure.pdf |format=PDF |title=NovoPath - Software Advancing Patient Diagnostics |publisher=NovoPath, Inc |date=2013 |accessdate=05 September 2020}}</ref><ref name="PsycheWindo">{{cite web |url=https://psychesystems.com/enterprise-laboratory-information-software/windopath/ |title=WindoPath Ē.ssential |publisher=Psychē Systems Corporation |accessdate=05 September 2020}}</ref> Examples of pathology-driven reflex testing in use today include testing for additional biomarkers for non-small-cell lung carcinoma (NSCLC) adenocarcinoma<ref name="SundinPath19">{{cite journal |url=https://www.medlabmag.com/article/1619 |title=Pathology-Driven Reflex Testing of Biomarkers |journal=Medical Lab Management |author=Sundin, T. |volume=8 |issue=11 |page=6 |year=2019}}</ref>, HPV testing in addition to cervical cytology examination<ref name="FDANewApproaches19">{{cite web |url=https://www.fda.gov/media/122799/download |title=New Approaches in the Evaluation for High-Risk Human Papillomavirus Nucleic Acid Detection Devices |author=U.S. Food and Drug Administration |publisher=U.S. Food and Drug Administration |date=08 March 2019 |accessdate=05 September 2020}}</ref><ref name="StolerAdjunctive15">{{cite book |chapter=Chapter 9: Adjunctive Testing |title=The Bethesda System for Reporting Cervical Cytology |author=Stoler, M.H.; Raab, S.S.; Wilbur, D.C. |editor=Nayar, R.; Wilbur, D. |publisher=Springer |pages=287–94 |year=2015 |doi=10.1007/978-3-319-11074-5_9 |isbn=9783319110745}}</ref> (discussed further in "adjunctive testing"), and additional automatic testing based off routine coagulation assays at hemostasis labs.<ref name="MohammedDevel19">{{cite journal |title=Development and implementation of an expert rule set for automated reflex testing and validation of routine coagulation tests in a large pathology network |journal=International Journal of Laboratory Hematology |author=Mohammed, S.; Priebbenow, V.U.; Pasalic, L. et al. |volume=41 |issue=5 |pages=642–49 |year=2019 |doi=10.1111/ijlh.13078 |pmid=31271498}}</ref>
* '''automated reflex testing''': Some PIMS vendors include pre-loaded, customizable lists of reflex tests associated with certain pathology procedures and their associated diagnoses. Optimally, these reflex texts are automatically suggested at specimen reception, based on specimen and/or pathology test type.<ref name="NovoPathSoftware13">{{cite web |url=https://www.novopath.com/content/pdf/novopathbrochure.pdf |format=PDF |title=NovoPath - Software Advancing Patient Diagnostics |publisher=NovoPath, Inc |date=2013 |accessdate=05 September 2020}}</ref><ref name="PsycheWindo">{{cite web |url=https://psychesystems.com/enterprise-laboratory-information-software/windopath/ |title=WindoPath Ē.ssential |publisher=Psychē Systems Corporation |accessdate=05 September 2020}}</ref> Examples of pathology-driven reflex testing in use today include testing for additional biomarkers for non-small-cell lung carcinoma (NSCLC) adenocarcinoma<ref name="SundinPath19">{{cite journal |url=https://www.medlabmag.com/article/1619 |title=Pathology-Driven Reflex Testing of Biomarkers |journal=Medical Lab Management |author=Sundin, T. |volume=8 |issue=11 |page=6 |year=2019}}</ref>, HPV testing in addition to cervical cytology examination<ref name="FDANewApproaches19">{{cite web |url=https://www.fda.gov/media/122799/download |title=New Approaches in the Evaluation for High-Risk Human Papillomavirus Nucleic Acid Detection Devices |author=U.S. Food and Drug Administration |publisher=U.S. Food and Drug Administration |date=08 March 2019 |accessdate=05 September 2020}}</ref><ref name="StolerAdjunctive15">{{cite book |chapter=Chapter 9: Adjunctive Testing |title=The Bethesda System for Reporting Cervical Cytology |author=Stoler, M.H.; Raab, S.S.; Wilbur, D.C. |editor=Nayar, R.; Wilbur, D. |publisher=Springer |pages=287–94 |year=2015 |doi=10.1007/978-3-319-11074-5_9 |isbn=9783319110745}}</ref> (discussed further in "adjunctive testing"), and additional automatic testing based off routine coagulation assays at hemostasis labs.<ref name="MohammedDevel19">{{cite journal |title=Development and implementation of an expert rule set for automated reflex testing and validation of routine coagulation tests in a large pathology network |journal=International Journal of Laboratory Hematology |author=Mohammed, S.; Priebbenow, V.U.; Pasalic, L. et al. |volume=41 |issue=5 |pages=642–49 |year=2019 |doi=10.1111/ijlh.13078 |pmid=31271498}}</ref>


* adjunctive testing: Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."<ref name="SegensAdjunct11">{{cite web |url=https://medical-dictionary.thefreedictionary.com/adjunct+test |title=adjunct test |work=Segen's Medical Dictionary |date=2011 |accessdate=05 September 2020}}</ref> A common adjunctive test performed in [[cytopathology]] is HPV testing.<ref name="FDANewApproaches19" /><ref name="StolerAdjunctive15" /> The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology<ref name="FDANewApproaches19" />:
* '''adjunctive testing''': Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."<ref name="SegensAdjunct11">{{cite web |url=https://medical-dictionary.thefreedictionary.com/adjunct+test |title=adjunct test |work=Segen's Medical Dictionary |date=2011 |accessdate=05 September 2020}}</ref> A common adjunctive test performed in [[cytopathology]] is HPV testing.<ref name="FDANewApproaches19" /><ref name="StolerAdjunctive15" /> The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology<ref name="FDANewApproaches19" />:


<blockquote>In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.</blockquote>
<blockquote>In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.</blockquote>


:Some PIMS vendors allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process. However, ensure that any such solution is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.<ref name="StolerAdjunctive15" />
:Some PIMS vendors allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process.<ref name="TDHistoCyto">{{cite web |url=https://www.technidata-web.com/solutions-services/disciplines/anatomic-pathology |title=TD HistoCyto Livextens |publisher=Technidata SAS |accessdate=05 September 2020}}</ref> However, ensure that any such solution is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.<ref name="StolerAdjunctive15" />
 
* '''demand management''': Similar to test optimization or clinic decision support, demand management mechanisms help laboratories reduce the amount of unnecessary and duplicate testing they perform. Lang described what this process would look like in a system like a [[laboratory information management system]] (LIMS) in 2013<ref name="LangLab13">{{cite journal |title=Laboratory demand management of repetitive testing – time for harmonisation and an evidenced based approach |journal=Clinical Chemistry and Laboratory Medicine |author=Lang, T. |volume=51 |issue=6 |pages=1139–40 |year=2013 |doi=10.1515/cclm-2013-0063 |pmid=23420284}}</ref>:
 
<blockquote>When implementing a demand management tool it is important that the system used to manage a laboratory workload can correctly identify the patient and match requests with the patient’s medical record. Ideally there should be one unique identifier used (e.g., NHS number in the UK), which will allow the LIMS to interrogate the patient’s previous pathology result to allow identification of duplicate or inappropriate requests. If a subsequent request is blocked, then it is also important that there is real-time notification of a potential redundant test so that the requestor can make an informed choice on the clinical need of the test and if it is required to override the rule. It is important that there is a facility whereby the laboratory or requestor can record the reason for blocking a request or overriding the rule.</blockquote>


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}

Revision as of 17:24, 5 September 2020

Sandbox begins below

Broad feature set of a pathology information management solution

A pathology information management solution (PIMS) ...


  • automated reflex testing: Some PIMS vendors include pre-loaded, customizable lists of reflex tests associated with certain pathology procedures and their associated diagnoses. Optimally, these reflex texts are automatically suggested at specimen reception, based on specimen and/or pathology test type.[1][2] Examples of pathology-driven reflex testing in use today include testing for additional biomarkers for non-small-cell lung carcinoma (NSCLC) adenocarcinoma[3], HPV testing in addition to cervical cytology examination[4][5] (discussed further in "adjunctive testing"), and additional automatic testing based off routine coagulation assays at hemostasis labs.[6]
  • adjunctive testing: Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."[7] A common adjunctive test performed in cytopathology is HPV testing.[4][5] The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology[4]:

In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Some PIMS vendors allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process.[8] However, ensure that any such solution is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.[5]
  • demand management: Similar to test optimization or clinic decision support, demand management mechanisms help laboratories reduce the amount of unnecessary and duplicate testing they perform. Lang described what this process would look like in a system like a laboratory information management system (LIMS) in 2013[9]:

When implementing a demand management tool it is important that the system used to manage a laboratory workload can correctly identify the patient and match requests with the patient’s medical record. Ideally there should be one unique identifier used (e.g., NHS number in the UK), which will allow the LIMS to interrogate the patient’s previous pathology result to allow identification of duplicate or inappropriate requests. If a subsequent request is blocked, then it is also important that there is real-time notification of a potential redundant test so that the requestor can make an informed choice on the clinical need of the test and if it is required to override the rule. It is important that there is a facility whereby the laboratory or requestor can record the reason for blocking a request or overriding the rule.

References

  1. "NovoPath - Software Advancing Patient Diagnostics" (PDF). NovoPath, Inc. 2013. https://www.novopath.com/content/pdf/novopathbrochure.pdf. Retrieved 05 September 2020. 
  2. "WindoPath Ē.ssential". Psychē Systems Corporation. https://psychesystems.com/enterprise-laboratory-information-software/windopath/. Retrieved 05 September 2020. 
  3. Sundin, T. (2019). "Pathology-Driven Reflex Testing of Biomarkers". Medical Lab Management 8 (11): 6. https://www.medlabmag.com/article/1619. 
  4. 4.0 4.1 4.2 U.S. Food and Drug Administration (8 March 2019). "New Approaches in the Evaluation for High-Risk Human Papillomavirus Nucleic Acid Detection Devices". U.S. Food and Drug Administration. https://www.fda.gov/media/122799/download. Retrieved 05 September 2020. 
  5. 5.0 5.1 5.2 Stoler, M.H.; Raab, S.S.; Wilbur, D.C. (2015). "Chapter 9: Adjunctive Testing". In Nayar, R.; Wilbur, D.. The Bethesda System for Reporting Cervical Cytology. Springer. pp. 287–94. doi:10.1007/978-3-319-11074-5_9. ISBN 9783319110745. 
  6. Mohammed, S.; Priebbenow, V.U.; Pasalic, L. et al. (2019). "Development and implementation of an expert rule set for automated reflex testing and validation of routine coagulation tests in a large pathology network". International Journal of Laboratory Hematology 41 (5): 642–49. doi:10.1111/ijlh.13078. PMID 31271498. 
  7. "adjunct test". Segen's Medical Dictionary. 2011. https://medical-dictionary.thefreedictionary.com/adjunct+test. Retrieved 05 September 2020. 
  8. "TD HistoCyto Livextens". Technidata SAS. https://www.technidata-web.com/solutions-services/disciplines/anatomic-pathology. Retrieved 05 September 2020. 
  9. Lang, T. (2013). "Laboratory demand management of repetitive testing – time for harmonisation and an evidenced based approach". Clinical Chemistry and Laboratory Medicine 51 (6): 1139–40. doi:10.1515/cclm-2013-0063. PMID 23420284.