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[[File:COVID-22 Palmerston North posters MRD.jpg|right|280px]]Since it has started, the [[COVID-19]] [[pandemic]] has brought with it numerous challenges for society to face. How poised is a state and national government to truly lend assistance to its citizens in the face of a crisis? How does the increasing divide between the "haves" and "have nots," and the associated economic structures that lend to them, reveal the fragility of our society? What more can be done to fund epidemiology research? How can we improve our healthcare system to be better equipped to handle communicable disease response and better funded to provide more social services to a broader base of people? And what lessons can be learned from the successes and failures of providing accurate, responsive laboratory testing during pandemics?
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We've learned that the family of [[coronavirus]]es can be disruptive to humanity, having had past brushes with [[SARS]] and [[MERS]], yet we arguably [https://www.newscientist.com/article/mg24532724-700-we-were-warned-so-why-couldnt-we-prevent-the-coronavirus-outbreak/ haven't done enough] to research these and similar viruses to be more prepared. We were perhaps [https://doi.org/10.1098/rstb.2004.1487 fortunate in some ways] that SARS wasn't worse than it proved to be. However, responses by the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), and other organizations and agencies around the world during the SARS and MERS outbreaks laid the foundations for [[laboratory]] testing a novel coronavirus like [[SARS-CoV-2]]. [[Reverse transcription polymerase chain reaction|Reverse transcription PCR]] (RT-PCR) is again proving to be a useful diagnostic tool for identifying the virus in patient specimens. Other methods such as [[Lateral flow test|lateral flow assays]] (LFA) borrow from more rapid methods of identification, and other more rapid methods of testing such as antigen testing and reverse transcription [[loop-mediated isothermal amplification]] (RT-LAMP) lend additional support to testing. And while confusing—particularly given the unknowns surrounding the predictive ability of antibodies conferring immunity—serology antibody tests appear to have their place as well.  
==''Introduction to Quality and Quality Management Systems''==
{{ombox
| type      = content
| style    = width: 500px;
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
}}
The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.


These and related tests can be complex, as evidenced by the CLIA approval status of a strong majority of emergency use authorized (EUA) test kits. Performing these tests on complex instruments and then effectively using the data they provide require clear [[workflow]]s that can be at least partially automated. This is particularly vital given the paltry 13 percent of CLIA-certified U.S labs that are certified to perform moderate- and high-complexity testing. Additionally, given the value of test result data to governments agencies, [[Epidemiology|epidemiological]] researchers, and patients, it's important that reporting is clear, timely, and moderated. Laboratory informatics systems such as [[laboratory information management system]]s (LIMS) and [[laboratory information system]]s (LIS) can go a long way towards ensuring laboratory testing and reporting of communicable diseases goes smoothly.
;1. What is quality?
:''Key terms''
:[[Quality (business)|Quality]]
:[[Quality assurance]]
:[[Quality control]]
:''The rest''
:[[Data quality]]
:[[Information quality]]
:[[Nonconformity (quality)|Nonconformity]]
:[[Service quality]]
;2. Processes and improvement
:[[Business process]]
:[[Process capability]]
:[[Risk management]]
:[[Workflow]]
;3. Mechanisms for quality
:[[Acceptance testing]]
:[[Conformance testing]]
:[[Clinical quality management system]]
:[[Continual improvement process]]
:[[Corrective and preventive action]]
:[[Good manufacturing practice]]
:[[Malcolm Baldrige National Quality Improvement Act of 1987]]
:[[Quality management]]
:[[Quality management system]]
:[[Total quality management]]
;4. Quality standards
:[[ISO 9000]]
:[[ISO 13485]]
:[[ISO 14000|ISO 14001]]
:[[ISO 15189]]
:[[ISO/IEC 17025]]
:[[ISO/TS 16949]]
;5. Quality in software
:[[Software quality]]
:[[Software quality assurance]]
:[[Software quality management]]


Choosing just any [[Informatics (academic field)|informatics]] system and implementing it haphazardly in the laboratory doesn't automatically ensure improvements, however. Many elements of the system should be carefully considered. Does the system have a provider portal that is flexible in its ability to handle providers from many different healthcare facility types entering test orders and reviewing results? How well does it address the workflow of COVID-19 and other types of respiratory illness testing? Does it interface with the instruments you're using to test such illnesses, and at a reasonable cost? How well does it handle internal and external reporting requirements, as well as any data visualization and dashboarding you require? During outbreaks and pandemics, the system should improve your laboratory workflow, not slow you down. This includes the element of reporting, which is not only critical but also challenging even in relatively peaceful times of health. And how interoperable is the system with other clinical systems such as [[electronic health record]]s (EHR) and [[radiology information system]]s (RIS)? As we found out, academic and research laboratories wanting to assist with testing have at times been locked out due to their informatics system not interfacing cleanly with a hospital EHR.
<!--Place all category tags here-->
 
Hopefully this guide has provided important background in several areas, from COVID-19's historical impact and challenging health issues, to the current state of laboratory testing, reporting, and informatics applications being applied to fight its spread. As noted in the beginning, this pandemic and how humanity is dealing with it is rapidly changing us, as we try to keep up with ways to fend it off. That means information changes rapidly. An effort will be made to update this content as new information comes to light. In the meantime, stay safe and consider your informatics solutions with care.

Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

This book should not be considered complete until this message box has been removed. This is a work in progress.

The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems.

1. What is quality?
Key terms
Quality
Quality assurance
Quality control
The rest
Data quality
Information quality
Nonconformity
Service quality
2. Processes and improvement
Business process
Process capability
Risk management
Workflow
3. Mechanisms for quality
Acceptance testing
Conformance testing
Clinical quality management system
Continual improvement process
Corrective and preventive action
Good manufacturing practice
Malcolm Baldrige National Quality Improvement Act of 1987
Quality management
Quality management system
Total quality management
4. Quality standards
ISO 9000
ISO 13485
ISO 14001
ISO 15189
ISO/IEC 17025
ISO/TS 16949
5. Quality in software
Software quality
Software quality assurance
Software quality management


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