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[[File:LabMachines.jpg|right|400px]]Laboratories acquire data management software for many reasons, including improving accuracy, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface your systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.
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In many cases, a vendor's solution will have integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's interfaces are generally built on standardized communication tools, including messaging formats like [[Health Level 7]] (HL7).<ref name="Sinard06">{{cite book |url=https://link.springer.com/book/10.1007/0-387-28058-8 |title=Practical pathology informatics: Demystifying informatics for the practicing anatomic pathologist |author=Sinard, J. |publisher=Springer Science+Business Media |year=2006 |isbn=9780387280585}}</ref><ref name="MLOStaffInterfacing12">{{cite web |url=https://www.mlo-online.com/home/article/13004490/interfacing-the-lis |title=Interfacing the LIS |author=MLO Staff |work=Medical Laboratory Observer |publisher=Endeavor Business Media, LLC |date=01 August 2012 |accessdate=18 November 2021}}</ref> The HL7 messaging standards are particularly important to laboratory data management because they define how information is packaged and communicated from one party to another. Such standards set the language, structure, and data types required for seamless integration of various systems and instruments.<ref name="KimCreating05">{{cite web |url=http://www.kathykim.com/sitebuildercontent/sitebuilderfiles/ClinicalDataStandardsInHealthCare.pdf |archiveurl=https://web.archive.org/web/20170114055221/http://www.kathykim.com/sitebuildercontent/sitebuilderfiles/ClinicalDataStandardsInHealthCare.pdf |format=PDF |title=Creating Clinical Data Standards in Health Care: Five Case Studies |author=Kim, Katherine |publisher=California HealthCare Foundation |date=July 2005 |archivedate=14 January 2017 |accessdate=10 January 2020}}</ref> Health Level 7 describes the types of information communicated between such systems in the clinical environment as including "process control and status information for each device or analyzer, [as well as] each specimen, specimen container, and container carrier; information and detailed data related to patients, orders, and results; and information related to specimen flow algorithms and automated decision making."<ref name="HL711">{{cite web |url=http://www.hl7.org/implement/standards/product_brief.cfm?product_id=203 |archiveurl=https://web.archive.org/web/20170711070938/http://www.hl7.org/implement/standards/product_brief.cfm?product_id=203 |title=HL7 version 2.7 standard: Chapter 13 - Clinical laboratory automation |author=Health Level Seven International |date=2011 |archivedate=11 July 2017 |accessdate=18 November 2021}}</ref>
==''Introduction to Quality and Quality Management Systems''==
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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.


You may also want your laboratory informatics solution to be able to communicate with other software and databases. This is often done using [[application programming interface]]s (APIs) that depend on web services implementation protocols such as REST and SOAP.<ref name="MonusSOAP19">{{cite web |url=https://raygun.com/blog/soap-vs-rest-vs-json/ |title=SOAP vs REST vs JSON comparison [2019] |author=Monus, A. |work=Raygun |date=05 March 2021 |accessdate=18 November 2021}}</ref><ref name="LVAQuick18">{{cite web |url=https://www.labvantage.com/a-quick-guide-to-lims-web-services/ |title=A Quick Guide to LIMS Web Services |author=LabVantage Solutions |publisher=LabVantage Solutions, Inc |date=07 January 2018 |accessdate=18 November 2021}}</ref><ref name="GrandOneTool19">{{cite journal |title=One tool to find them all: A case of data integration and querying in a distributed LIMS platform |journal=Database |author=Grand, A.; Geda, E.; Mignone, A. et al. |volume=2019 |page=baz004 |year=2019 |doi=10.1093/database/baz004}}</ref> These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an [[enterprise resource planning]] (ERP) application. Perhaps the ERP system needs to create sample batches within the informatics solution, and when testing is done, have the results returned to the ERP. APIs and communication protocols make this happen.<ref name="LVAQuick18" />
;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|colwidth=30em}}

Latest revision as of 19:46, 9 February 2022

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Introduction to Quality and Quality Management Systems

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