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{{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
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| 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.
{|
| 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.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.
{|  
 
| STYLE="vertical-align:top;"|
The latest developments of public health informatics, such as [[geographic information system]]s (GIS), which use digitized maps from satellites or aerial photography, can be used to provide a large volume of data.<ref name="ChoiThePast12" /> This enables the combination of various information such as geographic location, trends, conditions, and spatial patterns. GIS along with the incorporation of mobile technology has proved to be useful in tracking infectious disease, public health disasters, and bioterrorism.
{| class="wikitable collapsible" border="1" cellpadding="10" cellspacing="0"
 
|-
==Paper-based surveillance==
  ! colspan="2" style="text-align:left; padding-left:20px; padding-top:10px; padding-bottom:10px;"|
Surveillance systems were mainly in the form of paper reports submitted from hospitals, physicians, and clinics to local health departments. In the United States, for example, these institutions forwarded their reports to a state level and eventually to the [[Centers for Disease Control and Prevention]] (CDC) through email or fax. The reports would reach their final destination to the World Health Organization (WHO). This system was not quite efficient due to the variation in type of data reported between states. In addition, the dependence on a paper-based system and the delay in the identification of diseases affected the response rate and management of outbreaks.
|-
 
  ! style="color:brown; background-color:#ffffee; width:500px;"| Regulation, Specification, or Guidance
Paper-based surveillance systems require exhaustive manual data entry and are often considered fragmented because data from different sections of a study are not collected or available. These documents are separately assessed as cases, clusters or trends and therefore are time consuming, limited by incomplete data collection and inadequate analytical capacity. Thus, they are incapable of providing timely information for public health action. Another drawback of paper-based surveillance systems is the vulnerability of the paper records, especially during cases of natural disasters. Further, these systems do not help in the globalization of trends or data.
  ! style="color:brown; background-color:#ffffee; width:700px;"| Requirement
 
|-  
==Modern surveillance systems==
  | 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]
Currently, there is a steady transformation into electronic surveillance systems delivering more timely data and information concerning a disease or a situation that can cause an outbreak. This transformation has been facilitated by the modern public health information network (PHIN), providing efficient information access and exchange among public health agencies at different levels. PHIN is standardized, allowing for efficient interoperability among different levels of public health entities.<ref name="HoytHealth14" /><ref name="YasnoffANat01">{{cite journal |title=A National Agenda for Public Health Informatics |journal=JAMIA |author=Yasnoff, W.A.; Overhage, J.M.; Humphreys, B.L. et al. |volume=8 |issue=6 |pages=535-545 |year=2001 |pmid=11687561 |pmc=PMC130064}}</ref> To put it in a simpler form, information in PHIN is shared through the network and can be stored and retrieved easily, and it could be tracked back to sources. Data shared through the network can be further analyzed to provide information that helps public health professionals and support their decision. Unlike paper-based surveillance systems, data in PHIN are stored digitally and are not easily destroyed.
  | style="background-color:white;" |'''5.1''' The system shall accurately record details of a sample's final disposition.
 
|-  
==Comparison between paper-based and electronic surveillance systems==
  | 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]
Generating adequate and meaningful data in a short time could not be achieved with paper-based surveillance systems because of the difficulty in retrieving the data. Furthermore, paper-based systems incur costs in terms of paper, labor, and space for storing. Paper-based data cannot be shared easily with other systems and are more susceptible to privacy and confidentiality breaches. The use of [[electronic health record]]s further enhances the early detection of cases, clusters, outbreaks, and trends of communicable diseases and environmental hazard exposures. These characteristics improve the chances of detection of disease surveillance, epidemics, natural disasters, and bioterrorism events. The use of systems, such as real-time outbreak detection systems, allows for the real time, daily detection, analysis, and dissemination of outbreak information to the targeted populations and agencies. The use of a geographic information system, such as HealthMap, has further improved the identification, monitoring, alerting, and responding to emerging diseases, pandemics, bioterrorism, and natural disasters, not only at the national but at the global level.<ref name="FanAmulti10">{{cite journal |title=A multi-function public health surveillance system and the lessons learned in its development: the Alberta Real Time Syndromic Surveillance Net |journal=Canadian Journal of Public Health |author=Fan, S.; Blair, C.; Brown, A. et al. |volume=101 |issue=6 |pages=454-8 |year=2010 |pmid=21370780}}</ref>
  | 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.
 
|-  
Real studied examples showed a clear difference between the paper-based surveillance system and PHIN. The examples proved that collecting information for disease surveillance using smartphone devices was faster and cheaper than paper-based surveys, which was considered the traditional way for collecting information about diseases. A surveillance study in Kenya about influenza and respiratory diseases was conducted using paper or smartphones surveys. This study included 2038 questionnaires, of which 1019 were paper based and 1019 were smartphone questionnaires. Researchers in this study found that 3% of smartphone questionnaires were incomplete compared with 5% of the paper-based questionnaires. Additionally, they found that seven of the paper-based questionnaires were duplicated, while no smartphone questionnaires were duplicated. Furthermore, uploading data from smartphone questionnaires took only eight hours, whereas it took 24 hours for paper-based questionnaires. Cost-wise, collecting and processing data from paper-based questionnaires was $61,830 and $45,546, respectively, for a smartphone questionnaire.<ref name="NjugunaDisease12">{{cite journal |url=https://www.healio.com/infectious-disease/practice-management/news/print/infectious-disease-news/%7Bd2f404e3-399e-428d-b821-653f73ddaf30%7D/disease-surveillance-via-smartphones-cheaper-faster-vs-paper-based-surveys |title=Disease surveillance via smartphones cheaper, faster vs. paper-based surveys |journal=Infectious Disease News |author=Njuguna, H.N. |volume=25 |issue=4 |pages=13 |year=2012}}</ref>
  | 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.
==Applications of PHI==
|-
Sources of data include sales records of over-the-counter (OTC) medication, rate of school absence combined with the rate of visits to the school clinic and behavioral factors associated with the transfer of sexually transmitted diseases. During epidemics and natural disasters public health reports are essential tools to estimate morbidity and mortality. In addition, surveillance data assist in the estimation of the resources and man power needed to handle these disasters. Bioterrorism is another concern where the public is exposed to sudden and uncontrolled circumstances of the biological agents' release. This was observed in the U.S. in the beginning of the twenty-first century, where letters containing anthrax spores had been mailed to different addresses in the country. This incident resulted in causalities and thousands of people who were at risk of exposure to the anthrax pathogen. It highlighted the weakness of public health surveillance systems at that time and urged authorities for more immediate actions. In addition, it raised several questions of the need to keep dangerous pathogens stored in the U.S. Army Medical Research Institute of Infectious Diseases. Public health infrastructures and surveillance systems became more prepared to detect and to take immediate actions if faced with similar situations. PHI played a role in the collection and analysis of real-time data that were introduced right after the bioterrorism attack.
|}
 
|}
The data can be either a direct stream or aggregated data over time that are sent periodically through a secured connection to the surveillance systems. Data are then analyzed and converted to information by the usage of statistical algorithms that detect anomalies that could help to identify outbreaks.<ref name="LombardoDisease07">{{cite book |title=Disease Surveillance: A Public Health Informatics Approach |author=Lombardo, J.S.; Buckeridge, D.L. |publisher=John Wiley and Sons |pages=488 |year=2007 |isbn=978-0-470-06812-0}}</ref>
 
 
PHI also played significant roles in responding to worldwide disasters, such as Hurricane Katrina and H1N1 influenza,11 shedding light on the importance and the role of public health in emergency disasters. This is realized by an up-to-date continuity of operations plan (COOP), which has an important role in preparation for disasters.12 This is achieved by collecting data, detecting a threat and responding to that threat correctly and suitable time.13 Hence, the main function of public health is to monitor and detect the population who is at risk and prevent them from facing diseases and outbreaks.
 
==References==
{{Reflist|colwidth=30em}}
 
==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.
 
<!--Place all category tags here-->
[[Category:LIMSwiki journal articles (added in 2018)‎]]
[[Category:LIMSwiki journal articles (all)‎]]
[[Category:LIMSwiki journal articles on public health informatics]]

Revision as of 17:13, 14 September 2019

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.