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Like any other communicable disease, laboratories handling specimens that are suspected or confirmed of containing the SARS-CoV-2 virus must take appropriate precautions to protect all stakeholders. This involves not only any in-house protocols for preventing contamination but also any official guidance that goes beyond or supersedes in-house protocols. Examples of guidance documents include the World Health Organization's ''[https://www.who.int/publications/i/item/WHO-WPE-GIH-2021.1 Laboratory biosafety guidance related to coronavirus disease (COVID-19)]'', the CDC's ''[https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19)]'', and the CDC's ''[https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-safety-practices.html Guidance for General Laboratory Safety Practices during the COVID-19 Pandemic]''. Additionally, it may be helpful to look to what other laboratories are doing. In a brief article published in ''The Lancet Microbe'', Choy highlights an International Federation of Clinical Chemistry and Laboratory Medicine Taskforce survey of biochemistry labs and how they've been mitigating biohazard risks associated with SARS-CoV-2. Actions include<ref name="ChoyChanges20">{{cite journal |title=Changes in clinical laboratory operations and biosafety measures to mitigate biohazard risks during the COVID-19 pandemic |journal=The Lancet Microbe |author=Choy, K.W. |volume=1 |issue=7 |pages=E273-E274 |year=2020 |doi=10.1016/S2666-5247(20)30168-3}}</ref>:
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* restricting laboratorian access to testing of suspected and confirmed COVID-19 patient samples;
==''Introduction to Quality and Quality Management Systems''==
* tightening of delivery and shipping procedures of suspected and confirmed COVID-19 patient samples;
{{ombox
* limiting add-on test requests for suspected and confirmed COVID-19 patients;
| type      = content
* increasing the frequency of disinfection; and
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* considering the expanded use of autoclaving before sample disposition.
| text      = This book should not be considered complete until this message box has been removed. This is a work in progress.
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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.


Additional aspects of operations that laboratory managers may wish to implement include "number of shifts per day, the number of staff per shift, total number of staff accessible to work in the laboratory, shift change frequency, team-splitting arrangements, and fixed work–rest days."<ref name="ChoyChanges20" /> Arranging staff into smaller teams while reducing the consecutive number of shifts worked may reduce risks; however, managers of labs struggling to meet turnaround times may feel like this isn't realistically possible. In the end, the safety of personnel must be of highest importance, even while trying to rapidly and accurately conduct COVID-19 testing.<ref name="ChoyChanges20" />
;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]]


==References==
<!--Place all category tags here-->
{{Reflist}}
 
==Citation information for this chapter==
'''Chapter''': 3. Adding COVID-19 and other virus testing to your laboratory
 
'''Edition''': Fall 2021
 
'''Title''': ''COVID-19 Testing, Reporting, and Information Management in the Laboratory''
 
'''Author for citation''': Shawn E. Douglas
 
'''License for content''': [https://creativecommons.org/licenses/by-sa/4.0/ Creative Commons Attribution-ShareAlike 4.0 International]
 
'''Publication date''': September 2021

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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