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==Sandbox begins below==
==Sandbox begins below==
{{Infobox journal article
|name        =
|image        =
|alt          = <!-- Alternative text for images -->
|caption      =
|title_full  = A review of the role of public health informatics in healthcare
|journal      = ''Journal of Taibah University Medical Sciences''
|authors      = Aziz, Hassan A.
|affiliations = Qatar University
|contact      = Email: Hassan dot Aziz at qu dot edu dot qa
|editors      =
|pub_year    = 2017
|vol_iss      = '''12'''(1)
|pages        = 78-81
|doi          = [http://10.1016/j.jtumed.2016.08.011 10.1016/j.jtumed.2016.08.011]
|issn        = 1658-3612
|license      = [http://creativecommons.org/licenses/by-nc-nd/4.0/ Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International]
|website      = [https://www.sciencedirect.com/science/article/pii/S1658361216301019 https://www.sciencedirect.com/science/article/pii/S1658361216301019]
|download    = [https://www.sciencedirect.com/science/article/pii/S1658361216301019/pdfft?md5=045bce391e357a16115e25d4ca6fc1ea&pid=1-s2.0-S1658361216301019-main.pdf https://www.sciencedirect.com/science/article/pii/S1658361216301019/pdfft] (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==
Recognized as information intensive, healthcare requires timely, accurate [[information]] from many different sources generated by health information systems (HIS). With the availability of information technology in today's world and its integration in healthcare systems; the term "[[public health informatics]]" (PHI) was coined and used. The main focus of PHI is the use of information science and technology for promoting population health rather than of individuals. PHI has a disease prevention rather than treatment focus in order to prevent chain of events or disease spread. Moreover, PHI often operates at the level of government rather than at the private sector. This review article provides an overview of the field of PHI and compares between paper-based surveillance systems and public health information networks (PHIN). The current trends and future challenges of applying PHI systems in KSA were also reported.


==Public health informatics: Introduction and definition==
==4. Results Review and Verification==
Public health informatics (PHI) is defined as the systematic application of information, computer science, and technology in areas of public health, including surveillance, prevention, preparedness, and health promotion. The main applications of PHI are 1. promoting the health of the whole population, which will ultimately promote the health of individuals<ref name="HoytHealth14">{{cite book |title=Health Informatics: Practical Guide for Healthcare and Information Technology Professionals |editor=Hoyt, R.E.; Yoshihashi, A.K. |publisher=Lulu.com |pages=534 |edition=6th |year=2014 |isbn=9781304791108}}</ref> and 2. preventing diseases and injuries by changing the conditions that increases the risk of the population.<ref name="ChenAReview14">{{cite journal |title=A Review of Data Quality Assessment Methods for Public Health Information Systems |journal=International Journal of Environmental Research and Public Health |author=Chen, H.; Hailey, D.; Wang, N.; Yu, P. |volume=11 |issue=5 |pages=5170-5207 |year=2014 |doi=10.3390/ijerph110505170 |pmid=24830450 |pmc=PMC4053886}}</ref> Basically, PHI is using informatics in public health data collection, [[Data analysis|analysis]], and actions. Emphasis on disease prevention in the population, realizing its objectives using a large variety of interventions, and work within governmental settings are aspects that make PHI different than other fields of [[Informatics (academic field)|informatics]].<ref name="YasnoffPublic2000">{{cite journal |title=Public health informatics: improving and transforming public health in the information age |journal=Journal of Public Health and Management and Practice |author=Yasnoff, W.A.; O'Carroll, P.W.; Koo, D. et al. |volume=6 |issue=6 |pages=67-75 |year=2000 |pmid=18019962}}</ref> The scope of PHI includes the conceptualization, design, development, deployment, refinement, maintenance, and evaluation of communication, surveillance, and information systems relevant to public health.<ref name="ChoiThePast12">{{cite journal |title=The past, present, and future of public health surveillance |journal=Scientifica |author=Choi, B.C. |volume=2012 |page=875253 |year=2012 |doi=10.6064/2012/875253 |pmid=24278752 |pmc=PMC3820481}}</ref> PHI could be considered one of the most useful systems in addressing disease surveillance, epidemics, natural disasters, and bioterrorism. The use of computerized global surveillance and data collection systems, such as [[health information exchange]] (HIE) and health information organization (HIO), could assist in population-level monitoring. This could help to avert the negative impact of a widespread global epidemic.
{|
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{| 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.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
[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-4-1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.5.1.4]
  | style="background-color:white;" |'''4.1''' The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]
  | style="background-color:white;" |'''4.2''' The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.
|-  
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68]<br />
[https://www.law.cornell.edu/cfr/text/21/211.100 21 CFR Part 211.100]<br />
[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (a)]<br />
[https://www.law.cornell.edu/cfr/text/21/211.188 21 CFR Part 211.188]<br />
[https://www.law.cornell.edu/cfr/text/21/211.194 21 CFR Part 211.194]<br />
[https://www.law.cornell.edu/cfr/text/45/170.315 45 CFR Part 170.315 (d)]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-3]<br />
[https://www.fbi.gov/services/cjis/cjis-security-policy-resource-center CJIS Security Policy 5.4.1.1]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf E.U. Commission Directive 2003/94/EC Article 9.2]<br />
[https://extranet.who.int/prequal/content/who-technical-report-series WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9]
  | style="background-color:white;" |'''4.3''' The system shall accurately maintain a full audit trail for modified results.
|-  
  | style="padding:5px; width:500px;" |
[https://www.law.cornell.edu/cfr/text/21/211.68 21 CFR Part 211.68 (b)]<br />
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. E-28–29]<br />
[[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3]<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 4.13.2.12]<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 5.9.4–5]<br />
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-4]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 3.2.6]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.11.4]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.7.1]<br />
[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 7.8.1.1]<br />
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP 10]
  | style="background-color:white;" |'''4.4''' The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-5]<br />
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements 4.9.11]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]<br />
[https://www.iso.org/standard/56115.html ISO 15189:2012 5.9.2]
  | style="background-color:white;" |'''4.5''' The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.
|-
  | style="padding:5px; width:500px;" |
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-4-6]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.2.10]<br />
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 2.4.1]<br />
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-6]
  | style="background-color:white;" |'''4.6''' The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.
|-
|}
|}


==Surveillance systems==
==5. Sample, Experiment, and Study Approval and Verification==
Surveillance in public health is the collection, analysis, and interpretation of data that are important for the prevention of injury and diseases. Through available data, possible early detection of outbreaks can be achieved through timely and complete receipt, review, and investigation of disease case reports. An inclusive surveillance effort supports timely investigation and identifies data needs for managing public health response to an outbreak or terrorist event.<ref name="MastrianInformatics17">{{cite book |chapter=Chapter 14: Informatics for Health Professionals |title=Informatics for Health Professionals |editor=Mastrian, K.; McConigle, D. |author=Kraft, M.R.; Androwitch, I.; Mastriak, K. et al. |publisher=Jones & Bartlett Learning |year=2017 |isbn=9781284102635}}</ref> Worldwide, governments are strengthening their public health disease surveillance systems, taking advantage of modern information technology to build an integrated, effective, and reliable disease reporting system.<ref name="WangEmergence08">{{cite journal |title=Emergence and control of infectious diseases in China |journal=The Lancet |author=Wang, L.; Wang, Y.; Jin, S. et al. |volume=372 |issue=9649 |page=1598-1605 |year=2008 |doi=10.1016/S0140-6736(08)61365-3}}</ref> A surveillance system, such as syndromic surveillance systems, could collect symptoms and clinical features of an undiagnosed disease or health event in near real time that might indicate the early stages of an outbreak or bioterrorism attack. For instance, local or regional public health departments could alert all the clinicians within an HIO about unique cases of a highly resistant infectious organism or a widespread of communicable diseases. Consequently, HIO can play an important role as part of PHI in providing available patient data in conditions of natural disaster when paper-based records might be destroyed or unavailable.
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==References==
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
{{Reflist|colwidth=30em}}
|-
 
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
==Notes==
|-
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. Otherwise, the article appears as originally posted, per the "no derivatives" portion of the license.
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
 
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
<!--Place all category tags here-->
|-
[[Category:LIMSwiki journal articles (added in 2018)‎]]
  | style="padding:5px; width:500px;" |[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-1]<br />[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP 5.9–10]
[[Category:LIMSwiki journal articles (all)‎]]
  | style="background-color:white;" |'''5.1''' The system shall accurately record details of a sample's final disposition.
[[Category:LIMSwiki journal articles on public health informatics]]
|-
  | style="padding:5px; width:500px;" |[https://www.aihaaccreditedlabs.org/Policies/Pages/default.aspx AIHA-LAP Policies 2018 2A.7.7.2]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-2]
  | style="background-color:white;" |'''5.2''' The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
|-  
  | style="padding:5px; width:500px;" |[https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160 (b)]<br />[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 C-5-3]<br />[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 6.1]
  | style="background-color:white;" |'''5.3''' The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
|-
|}
|}

Revision as of 17:13, 14 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

4. Results Review and Verification

Regulation, Specification, or Guidance Requirement

21 CFR Part 211.68 (b)
42 CFR Part 493.1241
ASTM E1578-18 C-4-1
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.4.1
ISO 15189:2012 5.5.1.4

4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.

ASTM E1578-18 C-4-2
EPA ERLN Laboratory Requirements 4.9.2
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.4.1
ISO 15189:2012 5.9.2

4.2 The system shall have the capability of automatically authorizing verification check tests and samples if they are within specification limits set by the instruments used to perform the tests.

21 CFR Part 211.68
21 CFR Part 211.100
21 CFR Part 211.160 (a)
21 CFR Part 211.188
21 CFR Part 211.194
45 CFR Part 170.315 (d)
ASTM E1578-18 C-4-3
CJIS Security Policy 5.4.1.1
EPA ERLN Laboratory Requirements 4.9.1 and 4.9.7
E.U. Commission Directive 2003/94/EC Article 9.2
WHO Technical Report Series, #986, Annex 2, 15.7 and 15.9

4.3 The system shall accurately maintain a full audit trail for modified results.

21 CFR Part 211.68 (b)
ABFT Accreditation Manual Sec. E-28–29
[AIHA-LAP Policies 2018 2A.7.7.2 and 7.7.3
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12
ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.9.4–5
ASTM E1578-18 C-4-4
EPA ERLN Laboratory Requirements 3.2.6
EPA ERLN Laboratory Requirements 4.9.2–3 and 4.9.11
EPA ERLN Laboratory Requirements 4.11.4
EPA QA/G-5 2.2.10
EPA QA/G-5 2.4.1
E.U. Annex 11-6
ISO 15189:2012 5.7.1
ISO/IEC 17025:2017 7.8.1.1
USDA Data and Instrumentation for PDP 10

4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.

ASTM E1578-18 C-4-5
EPA ERLN Laboratory Requirements 4.9.11
EPA QA/G-5 2.2.10
EPA QA/G-5 2.4.1
E.U. Annex 11-6
ISO 15189:2012 5.9.2

4.5 The system shall identify out-of-range results and clearly alert the appropriate individuals for further evaluation of the results.

ASTM E1578-18 C-4-6
EPA QA/G-5 2.2.10
EPA QA/G-5 2.4.1
E.U. Annex 11-6

4.6 The system shall allow for the comparison of entered results with pre-defined specification limits from master data, clearly alerting the user when the results exceed those specification limits.

5. Sample, Experiment, and Study Approval and Verification

Regulation, Specification, or Guidance Requirement
ASTM E1578-18 C-5-1
USDA Sample Processing and Analysis Procedures for PDP 5.9–10 		5.1 The system shall accurately record details of a sample's final disposition.
AIHA-LAP Policies 2018 2A.7.7.2
ASTM E1578-18 C-5-2 		5.2 The system should allow authorized personnel to view relevant metadata for results during the review and approval process, including the instruments and reagents used, raw data from instruments, and associated reports.
21 CFR Part 211.160 (b)
ASTM E1578-18 C-5-3
EPA 815-R-05-004 Chap. IV, Sec. 6.1 		5.3 The system should provide appropriate functions for specific sample statuses like "approved" and "rejected," including the ability to handle re-test, re-sampling, re-calculation, out-of-specification response and notification, and disposition functions.
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