Difference between revisions of "User:Shawndouglas/sandbox/sublevel9"

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==Sandbox begins below==
==Sandbox begins below==
{{Infobox journal article
|name        =
|image        =
|alt          = <!-- Alternative text for images -->
|caption      =
|title_full  = The development and application of bioinformatics core competencies to improve bioinformatics training and education
|journal      = ''PLOS Computational Biology''
|authors      = Mulder, Nicola; Schwartz, Russell; Brazas, Michelle, D.; Brooksbank, Carth; Gaeta, Bruno; Morgan, Sarah L.;<br />Pauley, Mark A.; Rosenwald, Anne; Rustici, Gabriella; Sierk, Michael; Warnow, Tandy; Welch, Lonnie
|affiliations = University of Cape Town, Carnegie Mellon University, Ontario Institute for Cancer Research, Wellcome Genome Campus, University of New South Wales, University<br />of Nebraska at Omaha, Georgetown University, University of Cambridge, Saint Vincent College, University of Illinois at Urbana-Champaign, Ohio University
|contact      = Email: nicola dot mulder at uct dot ac dot za
|editors      =
|pub_year    = 2018
|vol_iss      = '''14'''(2)
|pages        = e1005772
|doi          = [http://10.1371/journal.pcbi.1005772 10.1371/journal.pcbi.1005772]
|issn        = 1553-7358
|license      = [http://creativecommons.org/licenses/by/4.0/ Creative Commons Attribution 4.0 International]
|website      = [http://journals.plos.org/ploscompbiol/article?id=10.1371/journal.pcbi.1005772 http://journals.plos.org/ploscompbiol/article?id=10.1371/journal.pcbi.1005772]
|download    = [http://journals.plos.org/ploscompbiol/article/file?id=10.1371/journal.pcbi.1005772&type=printable http://journals.plos.org/ploscompbiol/article/file?id=10.1371/journal.pcbi.1005772&type=printable] (PDF)
}}
{{ombox
| type      = content
| style    = width: 500px;
| text      = This article should not be considered complete until this message box has been removed. This is a work in progress.
}}
==Abstract==
[[Bioinformatics]] is recognized as part of the essential knowledge base of numerous career paths in biomedical research and healthcare. However, there is little agreement in the field over what that knowledge entails or how best to provide it. These disagreements are compounded by the wide range of populations in need of bioinformatics training, with divergent prior backgrounds and intended application areas. The Curriculum Task Force of the International Society of Computational Biology (ISCB) Education Committee has sought to provide a framework for training needs and curricula in terms of a set of bioinformatics core competencies that cut across many user personas and training programs. The initial competencies developed based on surveys of employers and training programs have since been refined through a multiyear process of community engagement. This report describes the current status of the competencies and presents a series of use cases illustrating how they are being applied in diverse training contexts. These use cases are intended to demonstrate how others can make use of the competencies and engage in the process of their continuing refinement and application. The report concludes with a consideration of remaining challenges and future plans.


==Introduction==
==2. Sample Management==
The need for bioinformatics education and training is immense, but it is also diverse. There is a wide range of audiences who are potential recipients of training, each of which has different needs in terms of what skills or knowledge they require and at what depth. For example, someone training to be a bioinformatics engineer (which we define as someone who will actively be involved in the development and application of bioinformatics algorithms) requires in-depth knowledge of existing algorithms, how they work, how to critically evaluate them, and how to interpret the results. By contrast, a bioinformatics user (which we define as someone making use of bioinformatics resources in an applied context, such as in medical practice) would need a basic level of understanding of the methods and a stronger focus on the interpretation of the outputs. In a recent publication<ref name="WelchApplying16">{{cite journal |title=Applying, Evaluating and Refining Bioinformatics Core Competencies (An Update from the Curriculum Task Force of ISCB's Education Committee) |journal=PLOS Computational Biology |author=Welch, L.; Brooksban, C.; Schwartz, R. et al. |volume=12 |issue=5 |page=e1004943 |year=2016 |doi=10.1371/journal.pcbi.1004943 |pmid=27175996 |pmc=PMC4866758}}</ref>, the ISCB Education Committee’s Curriculum Task Force described the potential for refinement and application of bioinformatics core competencies for different user groups. Here, we describe the further refinement of these competencies and provide a series of use cases illustrating their applications to different bioinformatics education and training programs globally.
{|
| STYLE="vertical-align:top;"|
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
|-
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
|-
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-1]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.1''' The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-2]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.2''' The system shall record the current and historical storage location for the laboratory's standards and reagents.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-3]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.3''' The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-4]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.4''' The system shall require the recording of a standard and reagent's first opening date.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-5]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.5''' The system shall allow only active standards and reagents to be shown as available for use.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-6]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.14]
  | style="background-color:white;" |'''2.6''' The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-7]
  | style="background-color:white;" |'''2.7''' The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-8]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.4.2]
  | style="background-color:white;" |'''2.8''' The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/7/331.17 7 CFR Part 331.17]<br />
[https://www.law.cornell.edu/cfr/text/9/121.17 9 CFR Part 121.17]<br />
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
[https://www.law.cornell.edu/cfr/text/42/73.17 42 CFR Part 73.17]<br />
[https://www.astm.org/Standards/E1492.htm ASTM E1492-11 4.2.1]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-9]
  | style="background-color:white;" |'''2.9''' The system should provide a means to manually or automatically track sample inventory amounts and status.
|-
  | style="padding:5px; width:500px;" |[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-10]
  | style="background-color:white;" |'''2.10''' The system shall be able to link test methods and specifications to standards and reagents.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84]<br />
[https://www.law.cornell.edu/cfr/text/21/211.166 21 CFR Part 211.166–7]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.40 21 CFR Part 212.40 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/212.61 21 CFR Part 212.61]<br />
[https://www.law.cornell.edu/cfr/text/21/212.70 21 CFR Part 212.70 (e)]<br />
[https://www.law.cornell.edu/cfr/text/21/225.58 21 CFR Part 225.58]<br />
[https://www.law.cornell.edu/cfr/text/21/226.58 21 CFR Part 226.58]<br />
[https://www.law.cornell.edu/cfr/text/21/606.65 21 CFR Part 606.65 (c)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.151 21 CFR Part 606.151]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-2-11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.3.2]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.5]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.5]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.7]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 17.22–25]
  | style="background-color:white;" |'''2.11''' The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
|-
|}
|}


==Development of core competencies for bioinformatics==
==3. Core Laboratory Testing and Experiments==
The ISCB Curriculum Task Force undertook the task of identifying some of the breadth of needs for bioinformatics education, as described in a series of reports from the task force. This effort arose first from a series of surveys of current training practice and desired training needs<ref name="WelchAReport12">{{cite journal |title=A report of the Curriculum Task Force of the ISCB Education Committee |journal=PLOS Computational Biology |author=Welch, L.R.; Schwartz, R.; Lewitter, F. |volume=8 |issue=6 |page=e1002570 |year=2012 |doi=10.1371/journal.pcbi.1002570 |pmid=22761560 |pmc=PMC3386154}}</ref>, which identified a set of broad categories of training needs but also widespread disparities across programs in what was taught, how, and for what intended target audiences. An outcome of these surveys was the need for identifying a set of core competencies as broad categories of skills and training that cross different programs and training needs and that can provide a basis for discussing similarities and differences between programs and desired outcomes. This led to a further effort to define a set of initial core competencies<ref name="WelchBioinformatics14">{{cite journal |title=Bioinformatics curriculum guidelines: toward a definition of core competencies |journal=PLOS Computational Biology |author=Welch, L.; Lewitter, F; Schwartz, R. et al. |volume=10 |issue=3 |page=e1003496 |year=2014 |doi=10.1371/journal.pcbi.1003496 |pmid=24603430 |pmc=PMC3945096}}</ref> that in turn led to an intensive program of community engagement to refine these competencies to better serve the breadth of needs of the bioinformatics training community.
{|
 
| STYLE="vertical-align:top;"|
There were three major steps in the development of the core competencies: (1) defining the competencies needed for using bioinformatics, (2) defining a variety of user profiles describing distinct subgroups in need of training, and (3) defining how the competencies will apply to each user profile (scoring). The core competency framework was developed through an iterative process with input from multiple parties from diverse backgrounds with a connection to bioinformatics. In order to gain a broader appreciation of which competencies the bioinformatics community considers relevant for different bioinformatics user profiles, the ISCB Curriculum Task Force has run several competency workshops (discussion sessions for defining the competencies and their applications) both at ISCB conferences and at other bioinformatics education venues such as the GOBLET (Global Organisation for Bioinformatics Learning, Education and Training) Annual General Meeting. Each iteration of a competency workshop has greatly enhanced not only the competencies themselves but also the definitions of the user profiles<ref name="WelchApplying16" /> and the competency-use case scoring mechanism.
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
 
|-
Initially, the mapping of bioinformatics competencies to audiences considered three major user profiles: (1) the bioinformatics user; (2) the bioinformatics scientist; and (3) the bioinformatics engineer. Early competency workshops quickly surmised that these user profiles were too narrow and did not adequately capture the breadth of roles requiring bioinformatics competency and curriculum. Participants spent much of the workshop time defining a bioinformatics user or distinguishing a bioinformatics scientist from a bioinformatics engineer. The use case roles were subsequently expanded to better embody the breadth of bioinformatics users, including physicians, lab technicians, ethicists and biocurators, scientists (which include the discovery biologist, academic bioinformatics researcher, and core facility scientist), and engineers (which may be a bioinformatician in academia, bioinformatician in research institute, or software engineer). This change allowed for subsequent workshop participants to self-select according to the category of user with which they most identified.
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
 
|-
With user profiles better defined, competency workshops then struggled with the competencies themselves and their definitions. Several early competency definitions appeared to overlap. For example, “Apply knowledge of computing appropriate to the discipline (e.g., effectively utilize bioinformatics tools)” closely resembled “Analyze a problem and identify and define the computing requirements appropriate to its solution (e.g., define algorithmic time and space complexities and hardware resources required to solve a problem).” Workshop participants helped to reduce the redundancy in our initial set of bioinformatics competencies from 20 competencies to a refined set of 16 competencies.
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
 
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
Competency workshops have additionally helped to revise the scoring of competencies for each user profile. Early workshops scored the applicability of a bioinformatics competency to a particular profile with a simple yes/no response, which did not allow for an appreciation of the depth of the competency necessary for a given profile. Such a scoring approach, while better than no score, would not be helpful when developing a curriculum for a specific user profile. Subsequent workshops used a graded scoring approach, with grades ranging from 1 (no competency required) to 4 (specialist knowledge required). This, too, proved too ambiguous to allow for meaningful discussion and classification. The scoring approach was thus revised again to the current model, which uses the Bloom’s Revised Taxonomy<ref name="AndersonATax01">{{cite book |title=A Taxonomy for Learning, Teaching, and Assessing: A Revision of Bloom's Taxonomy of Educational Objectives |editor=Anderson, L.W.; Krathwohl, D.R. |publisher=Pearson |pages=336 |year=2001 |isbn=9780801319037}}</ref> terms: knowledge, comprehension, application, analysis, synthesis, and evaluation. While the use of Bloom’s Taxonomy has been useful in mapping competency levels to each of the user profiles, this change required refinement of the competency list as several of the earlier competencies incorporated Bloom’s Taxonomy terms.
|-
 
  | style="padding:5px; width:500px;" |
Overall, competency workshops have been invaluable to the enhancement and refinement of the bioinformatics competencies. Through these workshops, the ISCB Curriculum Task Force has been able to construct a useful set of bioinformatics competencies that curriculum developers can use to develop, compare, and assess impactful bioinformatics training programs for a wide range of audiences and ultimately help establish bioinformatics skills in such audiences.<ref name="WelchBioinformatics14" />
[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (d)]<br />[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-1]<br />[https://www.iso.org/standard/56115.html ISO 15189:2012 5.3.2.7]
 
  | style="background-color:white;" |'''3.1''' The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
Table 1 reports the current state of the competencies developed and refined through this community engagement process. Tables 2–4 map these refined competencies to a broader set of personas, suggested over the course of the Task Force’s community engagement efforts, via Bloom’s Taxonomy terms. For reference, Table 5 provides examples and definitions of the Bloom's Revised Taxonomy terms. In the next section, we provide some examples of how the competencies have been applied in a variety of training contexts.
|-
 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.84 21 CFR Part 211.84 (e)]<br />[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-2]
==References==
  | style="background-color:white;" |'''3.2''' The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
{{Reflist|colwidth=30em}}
|-
 
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1252 42 CFR Part 493.1252 (d)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-3]
==Notes==
  | style="background-color:white;" |'''3.3''' The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
This presentation is faithful to the original, with only a few minor changes to presentation, spelling, and grammar. PMCID and DOI were added when they were missing from the original reference.
|-
 
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-4]
<!--Place all category tags here-->
  | style="background-color:white;" |'''3.4''' The system shall be able to check physical, control, and specification limits for an instrument sample.
[[Category:LIMSwiki journal articles (added in 2018)‎]]
|-
[[Category:LIMSwiki journal articles (all)‎]]
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-6]
[[Category:LIMSwiki journal articles on bioinformatics]]
  | style="background-color:white;" |'''3.5''' The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
[[Category:LIMSwiki journal articles on education]]
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-7]
  | style="background-color:white;" |'''3.6''' The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-8]
  | style="background-color:white;" |'''3.7''' The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-9]
  | style="background-color:white;" |'''3.8''' The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-10]
  | style="background-color:white;" |'''3.9''' The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
|-
  | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.8.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-11]
  | style="background-color:white;" |'''3.10''' The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
|-
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-12]
  | style="background-color:white;" |'''3.11''' The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
|-
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/42/493.1241 42 CFR Part 493.1241]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-13]<br />[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]
  | style="background-color:white;" |'''3.12''' The system should effectively alert users upon entry of out-of-specification test results.
|-
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (g)]<br />
[https://www.law.cornell.edu/cfr/text/21/606.160 21 CFR Part 606.160]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-3-14]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.1.2.3–4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.3.4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.8.1–4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.16]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 5.4.2]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 8.1.3]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.8]
  | style="background-color:white;" |'''3.13''' The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
|-
|}
|}

Revision as of 21:23, 19 September 2019

This is sublevel2 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead.

Sandbox begins below

2. Sample Management

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-2-1
EPA ERLN Laboratory Requirements 4.11.14 		2.1 The system shall record and maintain the chain of custody for the laboratory's standards and reagents.
ASTM E1578-18 C-2-2
EPA ERLN Laboratory Requirements 4.11.14 		2.2 The system shall record the current and historical storage location for the laboratory's standards and reagents.
ASTM E1578-18 C-2-3
EPA ERLN Laboratory Requirements 4.11.14 		2.3 The system shall allow the laboratory's previously standardized standards and reagents to be assigned a new standard value.
ASTM E1578-18 C-2-4
EPA ERLN Laboratory Requirements 4.11.14 		2.4 The system shall require the recording of a standard and reagent's first opening date.
ASTM E1578-18 C-2-5
EPA ERLN Laboratory Requirements 4.11.14 		2.5 The system shall allow only active standards and reagents to be shown as available for use.
ASTM E1578-18 C-2-6
EPA ERLN Laboratory Requirements 4.11.14 		2.6 The system shall allow standards and reagents to be flagged as no longer available for use by authorized personnel.
ASTM E1578-18 C-2-7 2.7 The system shall allow logically associated samples to be grouped together based on associated metadata such as sample type, test method, assigned user, and status.
ASTM E1578-18 C-2-8
EPA ERLN Laboratory Requirements 3.2
ISO/IEC 17025:2017 7.4.2 		2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.

7 CFR Part 331.17
9 CFR Part 121.17
21 CFR Part 211.84
42 CFR Part 73.17
ASTM E1492-11 4.2.1
ASTM E1578-18 C-2-9

2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.1.1
ASTM E1578-18 C-2-10 		2.10 The system shall be able to link test methods and specifications to standards and reagents.

21 CFR Part 211.84
21 CFR Part 211.166–7
21 CFR Part 211.194 (e)
21 CFR Part 212.40 (c)
21 CFR Part 212.61
21 CFR Part 212.70 (e)
21 CFR Part 225.58
21 CFR Part 226.58
21 CFR Part 606.65 (c)
21 CFR Part 606.151
ASTM E1578-18 C-2-11
EPA ERLN Laboratory Requirements 3.1.2.1
EPA ERLN Laboratory Requirements 4.3.2
EPA ERLN Laboratory Requirements 4.11.3.2
EPA QA/G-5 2.2.5
USDA Administrative Procedures for the PDP 8.5
WHO Technical Report Series, #986, Annex 2, 17.7
WHO Technical Report Series, #986, Annex 2, 17.22–25

2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.

3. Core Laboratory Testing and Experiments

Regulation, Specification, or Guidance Requirement

21 CFR Part 211.84 (d)
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.1.3.1
ASTM E1578-18 C-3-1
ISO 15189:2012 5.3.2.7

3.1 The system shall be able to record the identity of any standards and reagents used in laboratory testing, as well as for each sample or test during result entry. Linked to their identity should also be manufacturer and supplier information (such as certificates of testing); lot numbers; reception, preparation, and expiry dates; name of preparer; reliability testing results; and approval for use.
21 CFR Part 211.84 (e)
42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-2 		3.2 The system shall allow users to only select approved, non-expired standards and reagents for tests and experiments.
42 CFR Part 493.1252 (d)
ASTM E1578-18 C-3-3 		3.3 The system shall prevent standards, reagents, and other media from being used in testing if they would expire during the testing.
ASTM E1578-18 C-3-4 3.4 The system shall be able to check physical, control, and specification limits for an instrument sample.
ASTM E1578-18 C-3-6 3.5 The system should allow result entry for all tests linked to a single sample, as well as for multiple samples linked to a single test.
ASTM E1578-18 C-3-7 3.6 The system should allow user-definable result entry methods, e.g., uploading from a spreadsheet.
ASTM E1578-18 C-3-8 3.7 The system should allow outsourced samples to be tracked for aliquoting, chain-of-custody, results entry, and approval purposes.
ASTM E1578-18 C-3-9 3.8 The system shall allow the creation and assignment of retest workflow, while allowing the system or assigned user to determine the existence of a retesting due date and whether or not a new sample is required for the retest.
ASTM E1578-18 C-3-10 3.9 The system shall support, at a minimum, the floating point/real number, integer number, text, date, list, file, calculated, Boolean, and interval test result data types, allowing users to define the data type for specific test results.
AIHA-LAP Policies 2018 2A.7.8.2
ASTM E1578-18 C-3-11 		3.10 The system shall allow users to enter operators such as <, >, +, and - with numeric test results.
ASTM E1578-18 C-3-12 3.11 The system should allow inter- and intra-assay calculations to be performed, including the use of advanced math functions.
42 CFR Part 493.1241
ASTM E1578-18 C-3-13
EPA ERLN Laboratory Requirements 4.9.11 		3.12 The system should effectively alert users upon entry of out-of-specification test results.

21 CFR Part 211.194
21 CFR Part 212.60 (g)
21 CFR Part 606.160
ASTM E1578-18 C-3-14
EPA ERLN Laboratory Requirements 3.1.2.3–4
EPA ERLN Laboratory Requirements 3.2
EPA ERLN Laboratory Requirements 4.3.4
EPA ERLN Laboratory Requirements 4.8.1–4
EPA ERLN Laboratory Requirements 4.11.16
USDA Data and Instrumentation for PDP 5.4.2
USDA Data and Instrumentation for PDP 8.1.3
WHO Technical Report Series, #986, Annex 2, 15.8

3.13 The system shall be able to record a complete record of all data created in the course of a test or experiment, including instruments used, calculations performed, and associated graphs, charts, and spectra. The record should also be able to capture the signatures of those who performed the test or experiment, as well as those who reviewed the record for compliance purposes.
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