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You've probably heard terms like "software as a service" and "public cloud," and you may very well be familiar with their significance already. However, let's briefly run through the terminology associated with cloud services and deployments, as that terminology gets used abundantly, and it's best we're all clear on it from the start. Additionally, the cloud computing paradigm is expanding into areas like "hybrid cloud" and "serverless computing," concepts which may be new to many.
===Broad feature set of a pathology information management solution===


Mentioned earlier was NIST's 2011 definition of cloud computing. When that was published, NIST defined three service models and four deployment models (Table 1)<ref name="MellTheNIST11" />:
A pathology information management solution (PIMS) ...


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  | style="background-color:white; padding-left:10px; padding-right:10px;" colspan="2"|'''Table 1.''' The three service models and four deployment models for cloud computing, as defined by the National Institute of Standards and Technology (NIST) in 2011<ref name="MellTheNIST11" />
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" colspan="2"|'''Service models'''
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Model
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Description
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Software as a Service (SaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|"The capability provided to the consumer is to use the provider’s applications running on a cloud infrastructure. The applications are accessible from various client devices through either a thin client interface, such as a web browser (e.g., web-based email), or a program interface. The consumer does not manage or control the underlying cloud infrastructure including network, servers, operating systems, storage, or even individual application capabilities, with the possible exception of limited user-specific application configuration settings."
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Platform as a Service (PaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|"The capability provided to the consumer is to deploy onto the cloud infrastructure consumer-created or acquired applications created using programming languages, libraries, services, and tools supported by the provider. The consumer does not manage or control the underlying cloud infrastructure including network, servers, operating systems, or storage, but has control over the deployed applications and possibly configuration settings for the application-hosting environment."
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Infrastructure as a Service (IaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|"The capability provided to the consumer is to provision processing, storage, networks, and other fundamental computing resources where the consumer is able to deploy and run arbitrary software, which can include operating systems and applications. The consumer does not manage or control the underlying cloud infrastructure but has control over operating systems, storage, and deployed applications; and possibly limited control of select networking components (e.g., host firewalls)."
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" colspan="2"|'''Deployment models'''
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Model
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Description
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Private cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|"The cloud infrastructure is provisioned for exclusive use by a single organization comprising multiple consumers (e.g., business units). It may be owned, managed, and operated by the organization, a third party, or some combination of them, and it may exist on or off premises."
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Community cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|"The cloud infrastructure is provisioned for exclusive use by a specific community of consumers from organizations that have shared concerns (e.g., mission, security requirements, policy, and compliance considerations). It may be owned, managed, and operated by one or more of the organizations in the community, a third party, or some combination of them, and it may exist on or off premises."
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Public cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|"The cloud infrastructure is provisioned for open use by the general public. It may be owned, managed, and operated by a business, academic, or government organization, or some combination of them. It exists on the premises of the cloud provider."
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Hybrid cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|"The cloud infrastructure is a composition of two or more distinct cloud infrastructures (private, community, or public) that remain unique entities, but are bound together by standardized or proprietary technology that enables data and application portability (e.g., cloud bursting for load balancing between clouds)."
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Nearly a decade later, the picture painted in Table 1 is now more nuanced and varied, with slight changes in definitions, as well as additions to the service and deployment models. Cloudflare actually does a splendid job of describing these service and deployment models, so let's paraphrase from them, as seen in Table 2.
* '''automated reflex testing''': Some PIMS vendors include pre-loaded, customizable lists of reflex tests associated with certain pathology procedures and their associated diagnoses. Optimally, these reflex texts are automatically suggested at specimen reception, based on specimen and/or pathology test type.<ref name="NPSoftware13">{{cite web |url=https://www.novopath.com/content/pdf/novopathbrochure.pdf |format=PDF |title=NovoPath - Software Advancing Patient Diagnostics |publisher=NovoPath, Inc |date=2013 |accessdate=05 September 2020}}</ref><ref name="PsycheWindo">{{cite web |url=https://psychesystems.com/enterprise-laboratory-information-software/windopath/ |title=WindoPath Ē.ssential |publisher=Psychē Systems Corporation |accessdate=05 September 2020}}</ref> Examples of pathology-driven reflex testing in use today include testing for additional biomarkers for non-small-cell lung carcinoma (NSCLC) adenocarcinoma<ref name="SundinPath19">{{cite journal |url=https://www.medlabmag.com/article/1619 |title=Pathology-Driven Reflex Testing of Biomarkers |journal=Medical Lab Management |author=Sundin, T. |volume=8 |issue=11 |page=6 |year=2019}}</ref>, HPV testing in addition to cervical cytology examination<ref name="FDANewApproaches19">{{cite web |url=https://www.fda.gov/media/122799/download |title=New Approaches in the Evaluation for High-Risk Human Papillomavirus Nucleic Acid Detection Devices |author=U.S. Food and Drug Administration |publisher=U.S. Food and Drug Administration |date=08 March 2019 |accessdate=05 September 2020}}</ref><ref name="StolerAdjunctive15">{{cite book |chapter=Chapter 9: Adjunctive Testing |title=The Bethesda System for Reporting Cervical Cytology |author=Stoler, M.H.; Raab, S.S.; Wilbur, D.C. |editor=Nayar, R.; Wilbur, D. |publisher=Springer |pages=287–94 |year=2015 |doi=10.1007/978-3-319-11074-5_9 |isbn=9783319110745}}</ref> (discussed further in "adjunctive testing"), and additional automatic testing based off routine coagulation assays at hemostasis labs.<ref name="MohammedDevel19">{{cite journal |title=Development and implementation of an expert rule set for automated reflex testing and validation of routine coagulation tests in a large pathology network |journal=International Journal of Laboratory Hematology |author=Mohammed, S.; Priebbenow, V.U.; Pasalic, L. et al. |volume=41 |issue=5 |pages=642–49 |year=2019 |doi=10.1111/ijlh.13078 |pmid=31271498}}</ref>


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* '''adjunctive testing''': Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."<ref name="SegensAdjunct11">{{cite web |url=https://medical-dictionary.thefreedictionary.com/adjunct+test |title=adjunct test |work=Segen's Medical Dictionary |date=2011 |accessdate=05 September 2020}}</ref> A common adjunctive test performed in [[cytopathology]] is HPV testing.<ref name="FDANewApproaches19" /><ref name="StolerAdjunctive15" /> The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology<ref name="FDANewApproaches19" />:
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  | style="background-color:white; padding-left:10px; padding-right:10px;" colspan="2"|'''Table 2.''' A more modern look at service models and deployment models for cloud computing, as inspired largely by Cloudflare
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" colspan="2"|'''Service models'''
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Model
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Description
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Software as a Service (SaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This service model allows customers, via an internet connection and a web browser or app, to use software provided by and operated upon a cloud provider and its computing infrastructure. The customer isn't worried about anything hardware-related; from their perspective, they just want the software hosted by the cloud provider to be reliably and effectively operational. If the desired software is tied to strong regulatory or security standards, however, the customer must thoroughly vet the vendor, and even then, there is some risk in taking the word of the vendor that the application is properly secure since customers usually won't be able to test the software's security themselves (e.g., via a penetration test).<ref name="CFWhatIsSoft">{{cite web |url=https://www.cloudflare.com/learning/cloud/what-is-saas/ |title=What Is SaaS? SaaS Definition |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Platform as a Service (PaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This service model allows customers, via an internet connection and a web browser, to use not only the computing infrastructure (e.g., servers, hard drives, networking equipment) of the cloud provider but also development tools, operating systems, database management tools, middleware, etc. required to build web applications. As such, this allows a development team to spread around the world and still productively collaborate using the cloud provider's platform. However, app developers are essentially locked into the vendor's development environment, and additional security challenges may be introduced if the cloud provider has extended its infrastructure to one or more third parties. Finally, PaaS isn't truly "serverless," as applications won't automatically scale unless programmed to do so, and processes must be running most or all the time in order to be immediately available to users.<ref name="CFWhatIsPlat">{{cite web |url=https://www.cloudflare.com/learning/serverless/glossary/platform-as-a-service-paas/ |title=What is Platform-as-a-Service (PaaS)? |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Infrastructure as a Service (IaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This service model allows customers to use the computing infrastructure of a cloud provider, via the internet, rather than invest in their own on-premises computing infrastructure. From their internet connection and a web browser, the customer can set up and allocate the resources required (i.e., scalable infrastructure) to build and host web applications, store data, run code, etc. These activities are often facilitated with the help of virtualization and container technologies.<ref name="CFWhatIsInfra">{{cite web |url=https://www.cloudflare.com/learning/cloud/what-is-iaas/ |title=What Is IaaS (Infrastructure-as-a-Service)? |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Function as a Service (FaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This service model allows customers to run isolated or modular bits of code, preferably on local or "edge" cloud servers, when triggered by an element, such as an internet-connected device taking a reading or a user selecting an option in a web application. The customer has the luxury of focusing on writing and fine-tuning the code, and the cloud provider is the one responsible for allocating the necessary server and backend resources to ensure the code is run rapidly and effectively. As such, the customer doesn't have to think about servers at all, making FaaS a "serverless" computing model.<ref name="CFWhatIsFunction">{{cite web |url=https://www.cloudflare.com/learning/serverless/glossary/function-as-a-service-faas/ |title=What is Function-as-a-Service (FaaS)? |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Backend as a Service (BaaS)
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This service model allows customers to focus on front-end application services like client-side logic and user interface (UI), while the cloud provider provides the backend services for user authentication, database management, data storage, etc. The customer uses APIs and [[software development kit]]s (SDKs) provided by the cloud provider to integrate customer frontend application code with the vendor's backend functionality. As such, the customer doesn't have to think about servers, virtual machines, etc. However, in most cases, BaaS isn't truly serverless like FaaS, as actions aren't usually triggered by an element but rather run continuously (not as scalable as serverless). Additionally, BaaS isn't generally set up to run on the network's edge.<ref name="CFWhatIsBackend">{{cite web |url=https://www.cloudflare.com/learning/serverless/glossary/backend-as-a-service-baas/ |title=What is BaaS? Backend-as-a-Service vs. serverless |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;" colspan="2"|'''Deployment models'''
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  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Model
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Description
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Private cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This deployment model involves the provision of cloud computing infrastructure and services exclusively to one customer. Those infrastructure and service offerings may be hosted locally on-site or be remotely and privately managed and accessed via the internet and a web browser. Those organizations with high security and regulatory requirements may benefit from a private cloud, as they have direct control over how those policies are implemented on the infrastructure and services (i.e., don't have to consider the needs of other users sharing the cloud, as in public cloud). However, private cloud may come with higher costs.<ref name="CFWhatIsPrivate">{{cite web |url=https://www.cloudflare.com/learning/cloud/what-is-a-private-cloud/ |title=What Is a Private Cloud? Private Cloud vs. Public Cloud |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Community cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This deployment model, while not discussed often, still has some relevancy today. This model falls somewhere between private and public cloud, allowing authorized customers who need to work jointly on projects and applications, or require specific computing resources, in an integrated manner. The authorized customers typically have shared interests, policies, and security/regulatory requirements. Like private cloud, the computing infrastructure and services may be hosted locally at one of the customer's locations or be remotely and privately managed, with each customer accessing the community cloud via the internet. Given a set of common interest, policies, and requirements, the community cloud benefits all customers using the community cloud, as does the flexibility, scalability, and availability of cloud computing in general. However, with more users comes more security risk, and more detailed role-based or group-based security levels and enforcement may be required. Additionally, there must be solid communication and agreement among all members of the community to ensure the community cloud operates as efficiently and securely as possible.<ref name="TucavkovWhat20">{{cite web |url=https://phoenixnap.com/blog/community-cloud |title=What is Community Cloud? Benefits & Examples with Use Cases |author=Tucakov, D. |work=phoenixNAP Blog |publisher=phoenixNAP |date=18 June 2020 |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Public cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This deployment model is what typically comes to mind when "cloud computing" is discussed, involving a cloud provider that provides computing resources to multiple customers at the same time, though each individual customer's applications, data, and resources remain "hidden" from all other customers not authorized to view and access them. Those provided resources come in many different services model, with SaaS, PaaS, and IaaS being the most common. Traditionally, the public cloud has been touted as being a cost-effective, less complex, relatively secure means of handling computing resources and applications. However, for organizations tied to strong regulatory or security standards, the organizaiton must thoroughly vet the cloud vendor and its approach to security and compliance, as the provider may not be able to meet regulatory needs. There's also the concern of vendor lock-in or even loss of data if the customer becomes too dependent on that one vendor's services.<ref name="CFWhatIsPublic">{{cite web |url=https://www.cloudflare.com/learning/cloud/what-is-a-public-cloud/ |title=What Is Hybrid Cloud? Hybrid Cloud Definition |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>  
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Hybrid cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This deployment model takes both private cloud and public cloud models and tightly integrates them, along with potentially any existing on-premises computing infrastructure. (Figure 2) The optimal end result is one seamless operating computing infrastructure, e.g., where a private cloud and on-premises infrastructure houses critical operations and a public cloud is used for data and information backup or computing resource scaling. Advantages include great flexibility in deployments, improved backup options, resource scalability, and potential cost savings. Downsides include greater effort required to integrate complex systems and make them sufficiently secure. Note that hybrid cloud is different from multicloud in that it combines both public and private computing components.<ref name="CFWhatIsHybrid">{{cite web |url=https://www.cloudflare.com/learning/cloud/what-is-hybrid-cloud/ |title=What Is Hybrid Cloud? Hybrid Cloud Definition |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Multicloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This deployment model takes the concept of public cloud and multiplies it. Instead of the customer relying on a singular public cloud provider, they spread their cloud hosting, data storage, and application stack usage across more than one provider. The advantage to the customer is redundancy protection for data and systems and better value by tapping into different services. Downside comes with increased complexity in managing a multicloud deployment, as well as the potential for increased network latency and a greater cyber-attack surface. Note that multicloud requires multiple public clouds, though a private cloud can also be in the mix.<ref name="CFWhatIsMulti">{{cite web |url=https://www.cloudflare.com/learning/cloud/what-is-multicloud/ |title=What Is Multicloud? Multicloud Definition |publisher=Cloudflare, Inc |accessdate=21 August 2021}}</ref>
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  | style="background-color:white; padding-left:10px; padding-right:10px;"|Distributed cloud
  | style="background-color:white; padding-left:10px; padding-right:10px;"|This up-and-coming deployment model takes public cloud and expands it, such that a provider's public cloud infrastructure can be located in multiple places but be leveraged by a customer wherever they are, from a single control structure. As IBM puts it: "In effect, distributed cloud extends the provider's centralized cloud with geographically distributed micro-cloud satellites. The cloud provider retains central control over the operations, updates, governance, security, and reliability of all distributed infrastructure."<ref name="IBMDistrib20">{{cite web |url=https://www.ibm.com/cloud/learn/distributed-cloud |title=Distributed cloud |author=IBM Cloud Education |publisher=IBM |date=03 November 2020 |accessdate=21 August 2021}}</ref> Meanwhile, the customer can still access all infrastructure and services as an integrated cloud from a single control structure. The benefit of this model is that, unlike multicloud, latency issues can largely be eliminated, and the risk of failures in infrastructure and services can be further mitigated. Customers in regulated environments may also see benefits as data required to be in a specific geographic location can be better guaranteed with the distributed cloud. However, some challenges to this distributed model involve the allocation of public cloud resources to distributed use and determining who's responsible for bandwidth use.<ref name="CostelloTheCIO20">{{cite web |url=https://www.gartner.com/smarterwithgartner/the-cios-guide-to-distributed-cloud/ |title=The CIO’s Guide to Distributed Cloud |author=Costello, K. |work=Smarter With Gartner |date=12 August 2020 |accessdate=21 August 2021}}</ref>
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[[File:Hybrid Cloud.svg.png|right|400px|thumb|'''Figure 2.''' A representation of hybrid cloud. The cloud on the left represents the public cloud, being fed to the organization's main building. The cloud on the right represents the organization's private cloud, which is spread across all business locations. The main building feeds access to the public cloud to its other locations through its private cloud.]]While Table 2 addresses the basic ideas inherent to these service and deployment models, even providing some upside and downside notes, we still need to make further comparisons in order to highlight some fundamental differences in otherwise seemingly similar models. Let's first compare PaaS with serverless computing or FaaS. Then we'll examine the differences among hybrid, multi-, and distributed cloud models.
<blockquote>In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.</blockquote>


====1.2.1 Platform-as-a-service vs. serverless computing====
:Some PIMS vendors allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process.<ref name="TDHistoCyto">{{cite web |url=https://www.technidata-web.com/solutions-services/disciplines/anatomic-pathology |title=TD HistoCyto Livextens |publisher=Technidata SAS |accessdate=05 September 2020}}</ref> However, ensure that any such solution is capable of feeding any adjunctive test results into the final report (see the subsection on this topic).
As a service model, platform as a service or PaaS uses both the infrastructure layer and the platform layer of cloud computing. Hosted on the infrastructure are platform components like development tools, operating systems, database management tools, middleware, and more, which are useful for application design, development, testing, and deployment, as well as web service integration, database integration, state management, application versioning, and application instrumentation.<ref name="BonifacePlat10">{{cite journal |title=Platform-as-a-Service Architecture for Real-Time Quality of Service Management in Clouds |journal=Proceedings of the Fifth International Conference on Internet and Web Applications and Services |author=Boniface, M.; Nasser, B.; Papay, J. et al. |pages=155–60 |year=2010 |doi=10.1109/ICIW.2010.91}}</ref><ref name="XiongScalable14">{{cite journal |title=Scalable Architectures for Platform-as-a-Service Clouds: Performance and Cost Analysis |journal=Proceedings of the 2014 European Conference on Software Architecture |author=Xiong, H.; Fowley, F.; Pahl, C. et al. |pages=226–33 |year=2014 |doi=10.1007/978-3-319-09970-5_21}}</ref><ref name="ViolinoWhat19">{{cite web |url=https://www.infoworld.com/article/3223434/what-is-paas-software-development-in-the-cloud.html |title=What is PaaS? Platform-as-a-service explained |author=Violino, B. |work=InfoWorld |date=19 July 2019 |accessdate=21 August 2021}}</ref> In that regard, the user of the PaaS need not think about the backend processes.


Similarly, serverless computing or FaaS largely abstracts away (think "out of sight, out of mind") the servers running any software or code the user chooses to run on the cloud provider's infrastructure. The user practically doesn't need to know anything about the underlying hardware and operating system, or how that hardware and software handles the computational load of running your software or code, as the cloud provider ends up completely responsible for that. However, this is where the similarities stop.  
* '''demand management''': Similar to test optimization or clinical decision support, demand management mechanisms help laboratories reduce the amount of unnecessary and duplicate testing they perform. The idea of using demand management to reduce unnecessary pathology testing has been around since at least the beginning of the twenty-first century, if not well before, in the form of decision support systems and order request menus of informatics systems.<ref name="RaoPath03">{{cite journal |title=Pathology tests: is the time for demand management ripe at last? |journal=Journal of Clinical Pathology |author=Rao, G.G.; Crook, M.; Tillyer, M.L. |volume=56 |issue=4 |pages=243–48 |year=2003 |doi=10.1136/jcp.56.4.243 |pmid=12663633 |pmc=PMC1769923}}</ref> Lang described what the process of demand management would look like in a system like a [[laboratory information management system]] (LIMS) in 2013<ref name="LangLab13">{{cite journal |title=Laboratory demand management of repetitive testing – time for harmonisation and an evidenced based approach |journal=Clinical Chemistry and Laboratory Medicine |author=Lang, T. |volume=51 |issue=6 |pages=1139–40 |year=2013 |doi=10.1515/cclm-2013-0063 |pmid=23420284}}</ref>:


Let's use Amazon's AWS Lambda serverless computing service as an example for comparison with PaaS. Imagine you have some code you want performed on your website when an [[internet of things]] (IoT) device in the field takes a reading for your environmental laboratory. From your AWS Lambda account, you can "stage and invoke" the code you've written (it can be in any programming language) "from within one of the support languages in the AWS Lambda runtime environment."<ref name="AWSServer17">{{cite web |url=https://d1.awsstatic.com/whitepapers/serverless-architectures-with-aws-lambda.pdf |format=PDF |title=Serverless Architectures with AWS Lambda: Overview and Best Practices |publisher=Amazon Web Services |date=November 2017 |accessdate=21 August 2021}}</ref><ref name="AWSLambda">{{cite web |url=https://docs.aws.amazon.com/lambda/latest/dg/lambda-runtimes.html |title=Lambda runtimes |publisher=Amazon Web Services |accessdate=21 August 2021}}</ref> In turn, that runtime environment runs on top of Amazon Linux 2, an Amazon-developed version of Red Hat Enterprise running as a Linux server operating system.<ref name="MoreloWhat20">{{cite web |url=https://linuxhint.com/what_is_amazon_linux_2/ |title=What is Amazon Linux 2? |author=Morelo, D. |work=LinuxHint |date=2020 |accessdate=21 August 2021}}</ref> This can then be packaged into a container image that runs on Amazon's servers.<ref name="AWSLambda" /> When a designated event occurs (in this example, the internet-connected device taking a reading), a message is communicated—typically via an API—to the serverless code, which is then triggered, and Amazon Lambda provisions only the necessary resources to see the code to completion. Then the AWS server spins down those resources afterwards.<ref name="TRServerless20">{{cite web |url=https://www.techrepublic.com/article/serverless-computing-the-smart-persons-guide/ |title=Serverless computing: A cheat sheet |work=TechRepublic |date=25 December 2020 |accessdate=21 August 2021}}</ref> Yes, there are servers still involved, but the critical point is the customer need only to properly package their code up, without any concern whatsoever of how the AWS server manages its use and performance. In that regard, the code is said to be run in a "serverless" fashion, not because the servers aren't involved but because the code developer is effectively abstracted from the servers running and managing the code; the developer is left to only worry about the code itself.<ref name="TRServerless20" /><ref name="FrulingerWhatIs19">{{cite web |url=https://www.infoworld.com/article/3406501/what-is-serverless-serverless-computing-explained.html |title=What is serverless? Serverless computing explained |author=Fruhlinger, J. |work=InfoWorld |date=15 July 2019 |accessdate=21 August 2021}}</ref>
<blockquote>When implementing a demand management tool it is important that the system used to manage a laboratory workload can correctly identify the patient and match requests with the patient’s medical record. Ideally there should be one unique identifier used (e.g., NHS number in the UK), which will allow the LIMS to interrogate the patient’s previous pathology result to allow identification of duplicate or inappropriate requests. If a subsequent request is blocked, then it is also important that there is real-time notification of a potential redundant test so that the requestor can make an informed choice on the clinical need of the test and if it is required to override the rule. It is important that there is a facility whereby the laboratory or requestor can record the reason for blocking a request or overriding the rule.</blockquote>


PaaS is not serverless, however. First, a truly serverless model is significantly different in its scalability. The serverless model is meant to instantly provide computing resources based upon a "trigger" or programmed element, and then wind down those resources. This is perfect for the environmental lab wanting to upload remote sensor data to the cloud after each collection time; only the resources required for performing the action to completion are required, minimizing cost. However, this doesn't work well for a PaaS solution, which doesn't scale up automatically unless specifically programmed to. Sure, the developer using PaaS has more control over the development environment, but resources must be scaled up manually and left continuously running, making it less agile than serverless. This makes PaaS more suitable for more prescriptive and deliberate application development, though its usage-based pricing is a bit less precise than serverless. Additionally, serverless models aren't typically offered with development tools, as usually is the case with PaaS, so the serverless code developer must turn to their own development tools.<ref name="CFWhatIsPlat" /><ref name="SandersServer19">{{cite web |url=https://www.zdnet.com/article/serverless-computing-vs-platform-as-a-service-which-is-right-for-your-business/ |title=Serverless computing vs platform-as-a-service: Which is right for your business? |author=Sander, J. |work=ZDNet |date=01 May 2019 |accessdate=21 August 2021}}</ref>
:Today, some PIMS are designed to allow configurable rules and parameters to check for duplicate and unnecessary tests at various levels (e.g., by test ID or catalog type, activity type, or some other order level).<ref name="MorrisDemand18">{{cite journal |title=Demand management and optimization of clinical laboratory services in a tertiary referral center in Saudi Arabia |journal=Annals of Saudi Medicine |author=Morris, T.F.; Ellison, T.L.; Mutabbagani, M. et al. |volume=38 |issue=4 |pages=299–304 |year=2018 |doi=10.5144/0256-4947.2018.299 |pmid=30078029 |pmc=PMC6086671}}</ref><ref name="DXCLab">{{cite web |url=https://www.dxc.technology/healthcare/offerings/139499/139776-dxc_laboratory_information_management_lims |title=DXC Laboratory Information Management (LIMS) |publisher=DXC Technology Services, LLC |accessdate=05 September 2020}}</ref>


====1.2.2 Hybrid cloud vs. multicloud vs. distributed cloud====
* '''consent management''': In clinical medicine, patients typically must sign a form indicating informed consent to medical treatment.<ref name="AMAInformed">{{cite web |url=https://www.ama-assn.org/delivering-care/ethics/informed-consent |title=Informed Consent |work=Code of Medical Ethics |publisher=American Medical Association |accessdate=22 September 2020}}</ref> Biobanking facilities, which store biospecimens, also must collect consent forms regarding how a patient's biospecimens may be used.<ref name="AveryBiobank18">{{cite web |url=https://www.biobanking.com/biobanking-consent-informing-human-subjects-of-the-possibilities/ |title=Biobanking Consent: Informing Human Subjects of the Possibilities |author=Avery, D. |work=Biobanking.com |date=16 July 2018 |accessdate=22 September 2020}}</ref> In all cases, these consent documents drive how and when certain actions take place. Though not common, some LIMS like LabVantage Pathology by Software Point<ref name="SPLabVantPath">{{cite web |url=https://softwarepoint.com/solutions/product/labvantage-pathology |title=LabVantage Pathology |publisher=Software Point Oy |accessdate=22 September 2020}}</ref> provide consent management mechanisms within their PIMS, giving pathologists the ability to quickly verify consent details electronically. In biobanking solutions, this consent management process may be more rigorous to ensure biospecimen donors' preferences and regulatory requirements are being carefully followed. For example, the system may need to be able to prevent further use of a biospecimen and trigger sample and data deletion protocols when a donor withraws their consent to use.<ref name="BikaNCV15">{{cite web |url=https://www.bikalims.org/downloads/bika-open-source-biobank-management-system/at_download/file |format=PDF |title=NCB-H3A Cape Town Biobank Management System - Functional Requirements Overview & Phase I Objectives |author=SANBI; Bika Lab Systems |publisher=Bika Lab Systems |date=20 November 2015 |accessdate=22 September 2020}}</ref>
At casual glance, one might be led to believe these three deployment models aren't all that different. However, there are some core differences to point out, which may affect an organization's deployment strategy significantly. As Table 2 notes:


* Hybrid cloud takes private cloud and public cloud models (as well as an organization's local infrastructure) and tightly integrates them. This indicates a wide mix of computing services is being used in an integrated fashion to create value.<ref name="CFWhatIsHybrid" /><ref name="HurwitzWhat21">{{cite web |url=https://www.dummies.com/programming/cloud-computing/hybrid-cloud/what-is-hybrid-cloud-computing/ |title=What is Hybrid Cloud Computing? |work=Dummies.com |author=Hurwitz, J.S.; Kaufman, M.; Halper, F. et al. |publisher=John Wiley & Sons, Inc |date=2021 |accessdate=21 August 2021}}</ref>
* '''case management and review''': Most PIMS provide a means for managing pathology cases, recorded instances of disease and its attendant circumstances.<ref name="FarlexCase12">{{cite web |url=https://medical-dictionary.thefreedictionary.com/case |title=case |work=Farlex Partner Medical Dictionary |date=2012 |accessdate=25 September 2020}}</ref> This includes the management of case history, a collection of data concerning an individual, their family, their environment, their medical history, and other other information valuable for analyzing, diagnosing, reviewing, or otherwise instructing others on the case.<ref name="MKECase03">{{cite web |url=https://medical-dictionary.thefreedictionary.com/case |title=case |work=Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition |date=2003 |accessdate=25 September 2020}}</ref> Having an information system to better manage data entry, data analysis, case tracking, and case storage may aid in secondary and internal case reviews before final report, which have been shown to improve diagnostic accuracies and overall experiential knowledge of pathologists.<ref name="HuckKnowledge15">{{cite book |chapter=Chapter 7: Knowledge, Training, and Experience |title=Error Reduction and Prevention in Surgical Pathology |author=Huck, A.; Nosé, V. |editor=Nakhleh, R.E. |publisher=Springer |pages=103–114 |year=2015 |isbn=9781493923397 |url=https://books.google.com/books?id=HXAKBwAAQBAJ&pg=PA103}}</ref> Aspects of case manamagement and review that a PIMS may handle include automatic case creation, automatic and priority case assignment, and automatic case tracking, as well as limit case acces based on user permissions, and send alerts for clinical history follow-ups and other case statuses.<ref name="LLAnatom" /><ref name="PIMSPathX">{{cite web |url=http://pathxlis.com/downloads/PDFs/PathX%20-%20Capabilities%20Brochure.pdf |format=PDF |title=PathX Laboratory Information System |publisher=Physicians Independent Management Services |accessdate=25 September 2020}}</ref><ref name="LBAperioPathDX">{{cite web |url=https://www.leicabiosystems.com/digital-pathology/manage/aperio-path-dx/ |title=Aperio Path DX - Case Management Software |publisher=Leica Biosystems Nussloch GmbH |accessdate=25 September 2020}}</ref> Note that a handful of vendors such as Leica Biosystems provide stand-alone case management solutions that can be integrated with instruments and other LIS systems.<ref name="LBAperioPathDX" />
* Multicloud takes the concept of public cloud and multiplies it. This indicates that two or more public clouds are being used, without a private cloud to muddy the integration.<ref name="CFWhatIsMulti" />
 
* Distributed cloud takes public cloud and expands it to multiple edge locations. This indicates that a public cloud service's resources are strategically dispersed in locations as required by the user, while remaining accessible from and complementary to the user's private cloud or on-premises data center.<ref name="CostelloTheCIO20" /><ref name="SPWhatIs21">{{cite web |url=https://www.stackpath.com/edge-academy/distributed-cloud-computing/ |title=What is Distributed Cloud Computing? |work=Edge Academy |publisher=StackPath |date=2021 |accessdate=21 August 2021}}</ref>
* '''workflow management''': The tools for workflow management have become increasingly common in PIMS and other laboratory informatics applications over the years, with the idea of using automation to improves efficiencies and accuracies in the lab. However, workflows and protocols can differ—sometimes significantly—from one pathology lab to another. Being able to configure workflow pathways in the PIMS to be compliant with required testing protocols is vital. This is especially important with the gradual transition to more digital pathology methods, where digitally sharing cases and automatically scanned slide images has great value.<ref name="XifinIsYour20">{{cite web |url=https://www.xifin.com/resources/blog/201912/your-lab-ready-ai-digital-pathology-workflow |title=Is Your Lab Ready for an AI Digital Pathology Workflow? |publisher=XIFIN, Inc |date=03 January 2020 |accessdate=25 September 2020}}</ref> As such, vendors such as Orchard Software and XIFIN provide solutions with configurable workflows to help labs translate their workflows into the system.<ref name="OSOrchPath" /><ref name="XIFINLabInfoSys">{{cite web |url=https://www.xifin.com/products/laboratory-information-system |title=Laboratory Information System |publisher=XIFIN, Inc |accessdate=25 September 2020}}</ref>
 
* '''speech recognition and transcription management''': Like other medical fields, pathologists may utilize dictation and transcription services within their workflow. This has traditionally involved the pathologist speaking while a transcriptionist manually records the words to paper, or the pathologist scribbling notes in shorthand, with the transcriptionist "translating" the notes to usable clinical documentation. This could include anything from specimen descriptions and diagnoses to pathology obsevations and procedure notes. PIMS vendors have over the years added more automated methods to such tasks in their solutions, however, such as speech recognition modules and transcription management tools that, for example, automatically assign recordings to a transcriber's pending work list.<ref name="NPSoftware13" /><ref name="SPLabVantPath" /><ref name="AspyraAnaPath" /><ref name="PIMSPathX" />
 
:It's important to note, however, though PIMS vendors may market the speech recognition component of their solution at being 99 percent effective, past studies have shown 88.9 to 96 percent accuracy, though with tiny annual gains as the technology matures.<ref name="HodgsonRisks16">{{cite journal |title=Risks and benefits of speech recognition for clinical documentation: A systematic review |journal=JAMIA |author=Hodgson, T.; Coiera, E. |volume=23 |issue=e1 |pages=e169–79 |year=2016 |doi=10.1093/jamia/ocv152 |pmid=26578226 |pmc=PMC4954615}}</ref><ref name="ZhouAnal18">{{cite journal |title=Analysis of Errors in Dictated Clinical Documents Assisted by Speech Recognition Software and Professional Transcriptionists |journal=JAMA Network Open |author=Zhou, L.; Blackley, S.V.; Kowalski, L. et al. |volume=1 |issue=3 |at=e180530 |year=2018 |doi=10.1001/jamanetworkopen.2018.0530 |pmid=30370424 |pmc=PMC6203313}}</ref> If speech recognition is being used in lieu of a hired transcriptionist, it's especially vital to add manual editing and review before reporting.<ref name="ZhouAnal18" /><ref name="MatthewsWhyMed19">{{cite web |url=https://www.healthitoutcomes.com/doc/why-medical-dictation-is-still-better-than-voice-recognition-for-now-0001 |title=Why Medical Dictation Is Still Better Than Voice Recognition ... For Now |author=Matthews, K. |work=Health IT Outcomes |date=20 December 2019 |accessdate=25 September 2020}}</ref>
 
* '''storage and tissue bank management''': Biorepositories and pathology laboratories go hand-in-hand. A significant example can be found with the relationship medical school biorepositories have with their pathology labs and departments, as with, for example, Duke University<ref name="DukeBiorep">{{cite web |url=https://pathology.duke.edu/core-facilities-services/biorepository-precision-pathology-center |title=Biorepository & Precision Pathology Center |publisher=Duke University School of Medicine |accessdate=22 September 2020}}</ref>, University of Illinois Chicago<ref name="UIC_UIHealthBio">{{cite web |url=https://rrc.uic.edu/cores/rsd/biorepository/ |title=UI Health Biorepository |publisher=University of Illinois Chicago |accessdate=22 September 2020}}</ref>, and the Icahn School of Medicine at Mount Sinai.<ref name="IcahnBiorep">{{cite web |url=https://icahn.mssm.edu/research/portal/resources/deans-cores/biorepository-and-pathology |title=Biorepository and Pathology |publisher=Icahn School of Medicine at Mount Sinai |accessdate=22 September 2020}}</ref> However, even small pathology laboratories must also responsibly store and track their specimens, blocks, and slides, as well as the storage variables affecting them. Any reputable laboratory informatics solution will be able to track the location of such items through barcode or RFID support, as well as allowing for the creation of named storage locations in the system. However, some informatics solutions like AgileBio's LabCollector go a step further, providing data logging modules that are capable of connecting to data logger hardware and other sensors that capture environmental storage information such as temperature, humidity, light level, carbon dioxide level, and pressure. When a variable is out of range, an alert can be sent and logged.<ref name="AgileBioDataLog">{{cite web |url=https://www.labcollector.com/labcollector-lims/add-ons/data-logger/ |title=Data Logger |publisher=AgileBio |accessdate=22 September 2020}}</ref> And full-fledged biorepository management LIMS may have all the bells and whistles, including randomized biospecimen location auditing.<ref name="AIBiobank">{{cite web |url=https://www.autoscribeinformatics.com/industries/biobank-management-systems |title=Biobank Management LIMS |publisher=Autoscribe Informatics, Inc |date=22 September 2020}}</ref>
 
* '''task management''': Task management is a typical feature of a laboratory informatics solution, giving laboratorians the ability to assign tasks to individuals or groups of individuals, including analyses, results review, and more. In pathology labs, additional task and even management may include, for example, case assignment, slide or block assignment, grossing, staining, or some other pathology task. Additionally, some may incorporate this task management and tracking into a dashboard, to facility timely access to short-term status individual cases and specimens, and long-term aggregate data about cases, workflow, and workloads.<ref name="HalwaniAReal16">{{cite journal |title=A real-time dashboard for managing pathology processes |journal=Journal of Pathology Informatics |author=Halwani, F.; Li, W.C.; Banerjee, D. et al. |volume=7 |at=24 |year=2016 |doi=10.4103/2153-3539.181768 |pmid=27217974 |pmc=PMC4872478}}</ref>
 
* '''billing management with code support''': Instead of turning to a separate billing solution, pathology labs can often turn to PIMS for billing management. Vendors of LIS and LIMS have recognized not only the value of adding billing management to their solutions but also the many benefits that come with tying in diagnosis and billing code support. For example, a pathologist scanning a specimen into the system can not only have a case automatically generated but also auto-generate diagnosis codes based on the specimen or slide's code. Additionally, as has been witnessed during the [[COVID-19]] pandemic, billing rules may change rapidly during extraordinary events, requiring rapid used-defined billing rule changes.<ref name="FerranteCOVID20">{{cite web |url=https://www.foley.com/en/insights/publications/2020/04/covid19-cms-monumental-changes-medicare-telehealth |title=COVID-19: CMS Issues Monumental Changes to Medicare Telehealth: What You Need to Know |author=Ferrante, T.B.; Goodman, R.B.; Wein, E.H. |work=Insights, a Foley & Lardner LLP Blog |date=03 April 2020 |accessdate=25 September 2020}}</ref> As such, support for CPT, ICD-10, SNOMED CT, and other types of autocoding are somewhat common in today's PIMS.<ref name="NPSoftware13" /><ref name="LLAnatom" /><ref name="PIMSPathX" /><ref name="AspyraAnaPath" />
 
* '''reflex and adjunctive test reporting''': Ensure that a PIMS is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.<ref name="StolerAdjunctive15" /> Be careful with simple color-coding of results for interpretation, as they can be easily misinterpreted, including by the colorblind. A combination of symbol with color will help limit such misinterpretation.<ref name="SundinPath19" />
 
* '''structured data entry''': The concept of structured data entry (SDE) is relatively simple, but it may still get taken for granted. At its core, SDE is all about ensuring that entered data is based on a set of predefined conditions or rules, usually implemented through standardized forms with pre-determined drop-down and auto-populated fields.<ref name="PHIIUnderst">{{cite web |url=https://www.phii.org/sites/default/files/resource/files/Understanding%20Clinical%20Data%20and%20Workflow%20Guide.docx |format=DOCX |title=Analyzing Clinical Data and Workflows - 4. Understanding Clinical Data and Workflow |work=EHR Toolkit |author=Public Health Informatics Institute |accessdate=22 September 2020}}</ref> This typically confers numerous advantages, including easier data entry, easier and more standardized reporting, decrease costs, improve translational research, and ensure better compatibility and integration across different information systems.<ref name="PHIIUnderst" /><ref name="BataviaUsing18">{{cite journal |title=Using structured data entry systems in the electronic medical record to collect clinical data for quality and research: Can we efficiently serve multiple needs for complex patients with spina bifida? |journal=Journal of Pediatric Rehabilitative Medicine |volume=11 |issue=4 |pages=303–09 |year=2018 |doi=10.3233/PRM-170525 |pmid=30507591 |pmc=PMC6491202}}</ref> As such, some PIMS vendors like NovoPath and Orchard Software describe their solutions as having SDE elements such as enabling intelligent auto-loading of diagnosis and billing codes during case loading, allowing input fields to be required, and synoptic reporting support.<ref name="NPSoftwarePDF">{{cite web |url=https://www.novopath.com/content/pdf/novopathbrochure.pdf |format=PDF |title=NovoPath - Software Advancing Patient Diagnostics |publisher=NovoPath, Inc |date=2013 |accessdate=22 September 2020}}</ref><ref name="OSOrchPath">{{cite web |url=https://www.orchardsoft.com/orchard-pathology.html |title=Orchard Pathology |publisher=Orchard Software Corporation |accessdate=22 September 2020}}</ref>
 
* '''synoptic reporting''': [[LIS feature#Synoptic reporting|Synoptic reporting]] involves a structured, pre-formatted "checklist" of clinically and morphologically relevant data elements that help make pathology reporting more efficient, uniform, and relevant to internal and external stakeholders. Another way to put this is that synoptic reporting is SDE applied to the pathology report, often based upon specific reporting protocols by professional or standards organizations like the College of American Pathologists (CAP).<ref name="LLAnatom">{{cite web |url=https://www.ligolab.com/solutions/anatomic-pathology-solution |title=Anatomic Pathology Solutions |publisher=LigoLab, LLC |accessdate=23 September 2020}}</ref><ref name="NPSoftwarePDF" /> Support for synoptic reporting methods is typical within PIMS solutions, including support for configurable templates that can be adapted to changing and custom reporting protocols.
 
* '''correlative and consultive reporting''': In the late 1930s, the concept of correlating pathology results with clinical observations (and pathology) was beginning to be addressed in student textbooks.<ref name="JAMATextbook40">{{cite journal |title=''Textbook of Pathology. A Correlation of Clinical Observations and Pathological Findings'' |journal=JAMA |volume=114 |issue=2 |page=184 |year=1940 |doi=10.1001/jama.1940.02810020088032}}</ref> Today, the concept remains integral in medical practice and toxicologic study reporting.<ref name="SmithConstruct16">{{cite journal |title=Constructing Comments in a Pathology Report: Advice for the Pathology Resident |journal=Archives of Pathology & Laboratory Medicine |author=Smith, S.M.; Yearsley, M. |volume=140 |issue=10 |pages=1023–24 |year=2016 |doi=10.5858/arpa.2016-0220-ED |pmid=27684971}}</ref><ref name="RamaiahInterp17">{{cite journal |title=Interpreting and Integrating Clinical and Anatomic Pathology Results: Pulling It All Together |journal=Toxicologic Pathology |author=Ramaiah, L.; Hinrichs, M.J.; Skuba, E.V. et al. |volume=45 |issue=1 |pages=223–37 |year=2017 |doi=10.1177/0192623316677068 |pmid=27879439}}</ref><ref name="AulbachOver19">{{cite journal |title=Overview and considerations for the reporting of clinical pathology interpretations in nonclinical toxicology studies |journal=Veterinary Clinical Pathology |author=Aulbach, A.; Vitsky, A.; Arndt, T. et al. |volume=48 |issue=3 |pages=389–99 |year=2019 |doi=10.1111/vcp.12772 |pmid=31556157}}</ref> On the clinical side, a pathologist may include the phrase "clinical correlation is recommended" and additional comments. And in some cases, a third-party pathology consultation, with their own respective comments, is involved with specimen analysis.<ref name="KaplanWhatIs14">{{cite web |url=https://blog.corista.com/corista-digital-pathology-blog/bid/389513/What-is-a-Pathology-Consultation-When-is-it-Used |title=What is a Pathology Consultation? When is it Used? |author=Kaplan, K. |work=Corista Digital Pathology Blog |date=19 June 2014 |accessdate=23 September 2020}}</ref> These correlative and consultive comments or reports play an important part in the overall final pathology report and should not be omitted, particularly if differing opinions are involved. Vendors such as Orchard Software, LigoLab, and Aspyra tout their solutions' ability to tie together multiple reports and comments across pathology disciplines and consultants into one concise report.<ref name="OSOrchPath" /><ref name="LLAnatom" /><ref name="AspyraAnaPath">{{cite web |url=http://aspyra.com/anatomic-pathology/ |title=Anatomic Pathology |publisher=Aspyra, LLC |accessdate=23 September 2020}}</ref>
 
* '''CAP Cancer Reporting Protocol support''': Previously mentioned was CAP and its reporting protocols. In particular, CAP has its Cancer Reporting Protocols, which the CAP describe as providing "guidelines for collecting the essential data elements for complete reporting of malignant tumors and optimal patient care."<ref name="CAPCancerProt20">{{cite web |url=https://www.cap.org/protocols-and-guidelines/cancer-reporting-tools/cancer-protocol-templates |title=Cancer Protocol Templates |publisher=College of American Pathologists |date=April 2020 |accessdate=23 September 2020}}</ref> In conjunction with its electronic Cancer Checklists (eCCs)<ref name="CAPeCC">{{cite web |url=https://www.cap.org/laboratory-improvement/proficiency-testing/cap-ecc |title=CAP eCC |publisher=College of American Pathologists |accessdate=23 September 2020}}</ref>, pathologists are able to integrate CAP cancer reporting protocols of tumors, resections, and select biopsies into their PIMS' workflow and ensure proper reporting outcomes. Some PIMS vendors (e.g., Orchard Software, LigoLab<ref name="OSOrchPath" /><ref name="LLAnatom" />) explicitly indicate their solution integrates CAP's eCC templates and reporting protocols into their solution.
 
* '''annotated organ mapping''': In the world of PIMS, organ mapping refers to the concept of placing location-specific diagnostic information from specimen analyses into an anatomical diagram, typically during reporting, to more clearly communicate the results of those analyses. PIMS vendor WebPathLab, Inc. demonstrates this concept well with its Auto Organ Map Module, which not only shows an organ map in the rport but also simplifies data entry for the pathologist using SDE.<ref name="WPLAuto19">{{cite web |url=https://www.youtube.com/watch?v=NLr5_pLgYpg |title=AutoProstateMap |work=YouTube |author=WebPathLab, Inc |date=22 April 2019 |accessdate=23 September 2020}}</ref><ref name="WPLGUAuto">{{cite web |url=http://webpathlab.com/solutions/gu-auto-organ-map/ |title=GU Auto Organ Map Module |publisher=WebPathLab, Inc |accessdate=23 September 2020}}</ref> They use the prostate as an example, and explain that "selecting the predetermined number of quadrants in the prostate &#91;diagram&#93;, the system autopopulates the specimen description to each corresponding quadrant, and autofills the text for the Gross Description field, leaving only the dimension of each core to be entered by the grosser." NovoPath and Psyche Systems Corporation are additional examples of vendors incorporating organ mapping into their PIMS.<ref name="PsycheWindo" /><ref name="NPSoftwarePDF" />
 
* '''stain panel and unstained/control slide support''': A positive control slide is typically used to qualitatively assess how well a non-hematoxylin-eosin (non-H&E) or "special" stain performs against a gold standard like H&E, and the positive control is usually included with manufactured unstained slides (e.g., see Newcomer Supply's [https://www.newcomersupply.com/documents/product-flyers/Control%20Slide%20Brochure.pdf control slide catalog]). These slides may be used in histopathology (gauging the manifestation of disease in a tissue) and immunopathology (gauging immune response through visualization of an antibody-antigen interaction in a tissue). In particular, immunopathology and its associated immunohistochemistry may turn to special stain panels, which utilize multiple immunochemical stains to visualize the presence of more than one biomarker expression at the same time.<ref name="ShieldImmuno96">{{cite journal |title=Immunocytochemical staining of cytologic specimens. How helpful is it? |journal=American Journal of Clinical Pathology |author=Shield, P.W.; Perkins, G.; Wright, R.G. |volume=105 |issue=2 |pages=157–62 |year=1996 |doi=10.1093/ajcp/105.2.157 |pmid=8607438}}</ref><ref name="MartinEval14">{{cite journal |title=Evaluation of intestinal biopsies for pediatric enteropathy: A proposed immunohistochemical panel approach |journal=American Journal of Surgical Pathology |author=Martin, B.A.; Kerner, J.A.; Hazard, F.K. et al. |volume=38 |issue=10 |pages=1387–95 |year=2014 |doi=10.1097/PAS.0000000000000314 |pmid=25188866}}</ref><ref name="TorbensonImmuno19">{{cite web |url=https://abdominalkey.com/immunohistochemistry-and-special-stains-in-liver-pathology/ |title=Chapter 4. Immunohistochemistry and Special Stains in Liver Pathology |author=Torbenson, M.S. |work=Abdominalkey |date=24 November 2019 |accessdate=23 September 2020}}</ref> Vendors like NovoPath and Integrated Business Solutions Group explicitly state their solution supports the management of these types of slides and stain panels.<ref name="NPSoftwarePDF" /><ref name="IBSGLabLion">{{cite web |url=https://www.lablion.com/lablion-lis-laboratory-information-system |title=LABLION Software Suite |publisher=Integrated Business Solutions Group, LLC |accessdate=23 September 2020}}</ref>
 
* '''grossing support''': In medical terms, the adjective "gross" means "visible without the aid of a microscope."<ref name="MWGross">{{cite web |url=https://www.merriam-webster.com/dictionary/gross |title=Gross |work=Merriam-Webster.com Dictionary |publisher=Merriam-Webster |accessdate=23 September 2020}}</ref> By extension, gross examination (i.e., grossing) involves a macroscopic visual assessment of a biospecimen before preparation for microscopy, in order to gleen diagnostic information. Grossing remains a valuable skill used in modern pathology.<ref name="RutgushreeGrossing18">{{cite journal |title=Grossing of tissue specimens in oral pathology - Elemental guidelines |journal=International Journal of Oral Health Sciences |author=Ruthushree, T.; Harsha, M.; Amberkar, V.S. |volume=8 |issue=2 |pages=63–7 |year=2018 |doi=10.4103/ijohs.ijohs_32_18}}</ref><ref name="SchubertTheArt19">{{cite web |url=https://thepathologist.com/inside-the-lab/the-art-of-grossing |title=The Art of Grossing: Gross examination underpins all diagnoses based on tissue samples – but is this vital skill given the credit it deserves? |author=Schubert, M.; Nashm C; McCoy, J. |work=The Pathologist |date=26 November 2019 |accessdate=23 September 2020}}</ref> Some PIMS provide a grossing menu for pathologists to scan in and include commentary about a gross examination of a specimen.<ref name="LLAnatom" />
 
* '''high-risk patient follow-up''': A 2015 study published in ''Annals of Family Medicine'' showed evidence that "patients with high clinical complexity and high risk of readmission" benefited from early outpatient follow-up.<ref name="JosztHigh15">{{cite web |url=https://www.ajmc.com/view/high-risk-patients-benefit-significantly-from-early-follow-up-post-hospital-discharge |title=High-Risk Patients Benefit Significantly From Early Follow-up Post Hospital Discharge |author=Joszt, L. |work=The American Journal of Managed Care |date=20 April 2015 |accessdate=23 September 2020}}</ref><ref name="JacksonTimeli15">{{cite journal |title=Timeliness of Outpatient Follow-up: An Evidence-Based Approach for Planning After Hospital Discharge |journal=Annals of Family Medicine |author=Jackson, C.; Shahsahebi, M.; Wedlake, T. et al. |volume=13 |issue=2 |pages=115–22 |year=2015 |doi=10.1370/afm.1753}}</ref> The authors concluded : "Follow-up within seven days was associated with meaningful reductions in readmission risk for patients with multiple chronic conditions and a greater than 20% baseline risk of readmission, a group that represented 24% of discharged patients." Presumably some health care systems are synthesizing that information into their patient workflows, likely through some sort of scheduled event and alert in their primary informatics system, e.g., an [[electronic health record]] (EHR) system.<ref name="FutrellHealth18">{{cite web |url=https://www.mlo-online.com/information-technology/lis/article/13009479/health-information-technology-can-support-population-health-management |title=Health information technology can support population health management |author=Futrell, K. |work=Medical Laboratory Observer |date=18 April 2018 |accessdate=23 September 2020}}</ref> Though not common, at least one PIMS vendor—LigoLab, LLC—indicates their solution helps address high-risk patient follow-up, though it's not clear how.<ref name="LLAnatom" />
 
* '''research animal support''': Non-clinical pathology and toxicology laboratories assisting with research and evaluation studies may be handling non-human specimens or even live research animals. Additional data about these animals, animal groups, and animal tissues may need to be carefully documented as part of a study. As such, some solutions such as Instem's Provantis preclinical pathology solution are designed to record specific animal and group identifiers, animal cross-reference information, organ weight ratios, palpable mass diagnoses, and other attributes for reporting.<ref name="InstemProvantis">{{cite web |url=https://www.instem.com/solutions/provantis/index.php#2 |title=Provantis: Integrated preclinical software |publisher=Instem LSS Limited |accessdate=23 September 2020}}</ref>


As such, an organization's existing infrastructure and business demands, combined with its aspirations for moving into the cloud, will dictate their deployment model. But there are also advantages and disadvantages to each which may further dictate an organization's deployment decision. First, all three models provide some level of redundancy. If a failure occurs in one computing core (be it public, private, or local), another core can ideally provide backup services to fill the gap. However, each model does this in a slightly different way. In a similar way, if additional compute resources are required due to a spike in demand, each model can ramp up resources to smooth the demand spike. Hybrid and distributed clouds also have the benefit of making any future transition to a purely public cloud (be it singular or multi-) easier as part of an organization's processes and data are already found in public cloud.


Beyond these benefits, things diverge a bit. While hybrid clouds provide flexibility to maintain sensitive data in a private cloud or on-site, where security can be more tightly controlled, private clouds are resource-intensive to maintain. Additionally, due to the complexity of integrating that private cloud with all other resources, the hybrid cloud reveals a greater attack surface, complicates security protocols, and raises integration costs.<ref name="CFWhatIsHybrid" /> Multicloud has the benefit of reducing vendor lock-in (discussed later in this guide) by implementing resource utilization and storage across more than one public cloud provider. Should a need to migrate away from one vendor arrive, it's easier to continue critical services with the other public cloud vendor. This also lends to "shopping around" for public cloud services as costs lower and offerings change. However, this multicloud approach brings with it its own integration challenges, including differences in technologies between vendors, latency complexities between the services, increased points of attack with more integrations, and load balancing issues between the services.<ref name="CFWhatIsMulti" /> A distributed cloud model removes some of that latency and makes it easier to manage integrations and reduce network failure risks from one control center. It also benefits organizations requiring localized data storage due to regulations. However, with multiple servers being involved, it makes it a bit more difficult to troubleshoot integration and network issues across hardware and software. Additionally, implementation costs are likely to be higher, and security for replicated data across multiple locations becomes more complex and risky.<ref name="CostelloTheCIO20" /><ref name="EntradasoftWhatIs20">{{cite web |url=http://entradasoft.com/blogs/what-is-distributed-cloud |title=What is Distributed Cloud |publisher=Entradasoft |date=2000 |accessdate=21 August 2021}}</ref>


==References==
==References==
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{{Reflist|colwidth=30em}}

Latest revision as of 13:27, 6 September 2021

Broad feature set of a pathology information management solution

A pathology information management solution (PIMS) ...


  • automated reflex testing: Some PIMS vendors include pre-loaded, customizable lists of reflex tests associated with certain pathology procedures and their associated diagnoses. Optimally, these reflex texts are automatically suggested at specimen reception, based on specimen and/or pathology test type.[1][2] Examples of pathology-driven reflex testing in use today include testing for additional biomarkers for non-small-cell lung carcinoma (NSCLC) adenocarcinoma[3], HPV testing in addition to cervical cytology examination[4][5] (discussed further in "adjunctive testing"), and additional automatic testing based off routine coagulation assays at hemostasis labs.[6]
  • adjunctive testing: Adjunctive testing is testing "that provides information that adds to or helps interpret the results of other tests, and provides information useful for risk assessment."[7] A common adjunctive test performed in cytopathology is HPV testing.[4][5] The FDA described this as such in 2003, specifically in regards to expanding the use of the Digene HC2 assay as an adjunct to cytology[4]:

In women 30 years and older, the HC2 High-Risk HPV DNA test can be used with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Some PIMS vendors allow users to manually add an adjunctive test to a primary pathology test, or in some cases this may be enabled as part of an automated reflex testing process.[8] However, ensure that any such solution is capable of feeding any adjunctive test results into the final report (see the subsection on this topic).
  • demand management: Similar to test optimization or clinical decision support, demand management mechanisms help laboratories reduce the amount of unnecessary and duplicate testing they perform. The idea of using demand management to reduce unnecessary pathology testing has been around since at least the beginning of the twenty-first century, if not well before, in the form of decision support systems and order request menus of informatics systems.[9] Lang described what the process of demand management would look like in a system like a laboratory information management system (LIMS) in 2013[10]:

When implementing a demand management tool it is important that the system used to manage a laboratory workload can correctly identify the patient and match requests with the patient’s medical record. Ideally there should be one unique identifier used (e.g., NHS number in the UK), which will allow the LIMS to interrogate the patient’s previous pathology result to allow identification of duplicate or inappropriate requests. If a subsequent request is blocked, then it is also important that there is real-time notification of a potential redundant test so that the requestor can make an informed choice on the clinical need of the test and if it is required to override the rule. It is important that there is a facility whereby the laboratory or requestor can record the reason for blocking a request or overriding the rule.

Today, some PIMS are designed to allow configurable rules and parameters to check for duplicate and unnecessary tests at various levels (e.g., by test ID or catalog type, activity type, or some other order level).[11][12]
  • consent management: In clinical medicine, patients typically must sign a form indicating informed consent to medical treatment.[13] Biobanking facilities, which store biospecimens, also must collect consent forms regarding how a patient's biospecimens may be used.[14] In all cases, these consent documents drive how and when certain actions take place. Though not common, some LIMS like LabVantage Pathology by Software Point[15] provide consent management mechanisms within their PIMS, giving pathologists the ability to quickly verify consent details electronically. In biobanking solutions, this consent management process may be more rigorous to ensure biospecimen donors' preferences and regulatory requirements are being carefully followed. For example, the system may need to be able to prevent further use of a biospecimen and trigger sample and data deletion protocols when a donor withraws their consent to use.[16]
  • case management and review: Most PIMS provide a means for managing pathology cases, recorded instances of disease and its attendant circumstances.[17] This includes the management of case history, a collection of data concerning an individual, their family, their environment, their medical history, and other other information valuable for analyzing, diagnosing, reviewing, or otherwise instructing others on the case.[18] Having an information system to better manage data entry, data analysis, case tracking, and case storage may aid in secondary and internal case reviews before final report, which have been shown to improve diagnostic accuracies and overall experiential knowledge of pathologists.[19] Aspects of case manamagement and review that a PIMS may handle include automatic case creation, automatic and priority case assignment, and automatic case tracking, as well as limit case acces based on user permissions, and send alerts for clinical history follow-ups and other case statuses.[20][21][22] Note that a handful of vendors such as Leica Biosystems provide stand-alone case management solutions that can be integrated with instruments and other LIS systems.[22]
  • workflow management: The tools for workflow management have become increasingly common in PIMS and other laboratory informatics applications over the years, with the idea of using automation to improves efficiencies and accuracies in the lab. However, workflows and protocols can differ—sometimes significantly—from one pathology lab to another. Being able to configure workflow pathways in the PIMS to be compliant with required testing protocols is vital. This is especially important with the gradual transition to more digital pathology methods, where digitally sharing cases and automatically scanned slide images has great value.[23] As such, vendors such as Orchard Software and XIFIN provide solutions with configurable workflows to help labs translate their workflows into the system.[24][25]
  • speech recognition and transcription management: Like other medical fields, pathologists may utilize dictation and transcription services within their workflow. This has traditionally involved the pathologist speaking while a transcriptionist manually records the words to paper, or the pathologist scribbling notes in shorthand, with the transcriptionist "translating" the notes to usable clinical documentation. This could include anything from specimen descriptions and diagnoses to pathology obsevations and procedure notes. PIMS vendors have over the years added more automated methods to such tasks in their solutions, however, such as speech recognition modules and transcription management tools that, for example, automatically assign recordings to a transcriber's pending work list.[1][15][26][21]
It's important to note, however, though PIMS vendors may market the speech recognition component of their solution at being 99 percent effective, past studies have shown 88.9 to 96 percent accuracy, though with tiny annual gains as the technology matures.[27][28] If speech recognition is being used in lieu of a hired transcriptionist, it's especially vital to add manual editing and review before reporting.[28][29]
  • storage and tissue bank management: Biorepositories and pathology laboratories go hand-in-hand. A significant example can be found with the relationship medical school biorepositories have with their pathology labs and departments, as with, for example, Duke University[30], University of Illinois Chicago[31], and the Icahn School of Medicine at Mount Sinai.[32] However, even small pathology laboratories must also responsibly store and track their specimens, blocks, and slides, as well as the storage variables affecting them. Any reputable laboratory informatics solution will be able to track the location of such items through barcode or RFID support, as well as allowing for the creation of named storage locations in the system. However, some informatics solutions like AgileBio's LabCollector go a step further, providing data logging modules that are capable of connecting to data logger hardware and other sensors that capture environmental storage information such as temperature, humidity, light level, carbon dioxide level, and pressure. When a variable is out of range, an alert can be sent and logged.[33] And full-fledged biorepository management LIMS may have all the bells and whistles, including randomized biospecimen location auditing.[34]
  • task management: Task management is a typical feature of a laboratory informatics solution, giving laboratorians the ability to assign tasks to individuals or groups of individuals, including analyses, results review, and more. In pathology labs, additional task and even management may include, for example, case assignment, slide or block assignment, grossing, staining, or some other pathology task. Additionally, some may incorporate this task management and tracking into a dashboard, to facility timely access to short-term status individual cases and specimens, and long-term aggregate data about cases, workflow, and workloads.[35]
  • billing management with code support: Instead of turning to a separate billing solution, pathology labs can often turn to PIMS for billing management. Vendors of LIS and LIMS have recognized not only the value of adding billing management to their solutions but also the many benefits that come with tying in diagnosis and billing code support. For example, a pathologist scanning a specimen into the system can not only have a case automatically generated but also auto-generate diagnosis codes based on the specimen or slide's code. Additionally, as has been witnessed during the COVID-19 pandemic, billing rules may change rapidly during extraordinary events, requiring rapid used-defined billing rule changes.[36] As such, support for CPT, ICD-10, SNOMED CT, and other types of autocoding are somewhat common in today's PIMS.[1][20][21][26]
  • reflex and adjunctive test reporting: Ensure that a PIMS is capable of feeding any adjunctive test results into the final report, along with the results from the primary tests. Using adjunctive HPV test results as an example, the report should optimally include details such as assay name, manufacturer, the HPV types it covers, results, and any applicable educational notes and suggestions.[5] Be careful with simple color-coding of results for interpretation, as they can be easily misinterpreted, including by the colorblind. A combination of symbol with color will help limit such misinterpretation.[3]
  • structured data entry: The concept of structured data entry (SDE) is relatively simple, but it may still get taken for granted. At its core, SDE is all about ensuring that entered data is based on a set of predefined conditions or rules, usually implemented through standardized forms with pre-determined drop-down and auto-populated fields.[37] This typically confers numerous advantages, including easier data entry, easier and more standardized reporting, decrease costs, improve translational research, and ensure better compatibility and integration across different information systems.[37][38] As such, some PIMS vendors like NovoPath and Orchard Software describe their solutions as having SDE elements such as enabling intelligent auto-loading of diagnosis and billing codes during case loading, allowing input fields to be required, and synoptic reporting support.[39][24]
  • synoptic reporting: Synoptic reporting involves a structured, pre-formatted "checklist" of clinically and morphologically relevant data elements that help make pathology reporting more efficient, uniform, and relevant to internal and external stakeholders. Another way to put this is that synoptic reporting is SDE applied to the pathology report, often based upon specific reporting protocols by professional or standards organizations like the College of American Pathologists (CAP).[20][39] Support for synoptic reporting methods is typical within PIMS solutions, including support for configurable templates that can be adapted to changing and custom reporting protocols.
  • correlative and consultive reporting: In the late 1930s, the concept of correlating pathology results with clinical observations (and pathology) was beginning to be addressed in student textbooks.[40] Today, the concept remains integral in medical practice and toxicologic study reporting.[41][42][43] On the clinical side, a pathologist may include the phrase "clinical correlation is recommended" and additional comments. And in some cases, a third-party pathology consultation, with their own respective comments, is involved with specimen analysis.[44] These correlative and consultive comments or reports play an important part in the overall final pathology report and should not be omitted, particularly if differing opinions are involved. Vendors such as Orchard Software, LigoLab, and Aspyra tout their solutions' ability to tie together multiple reports and comments across pathology disciplines and consultants into one concise report.[24][20][26]
  • CAP Cancer Reporting Protocol support: Previously mentioned was CAP and its reporting protocols. In particular, CAP has its Cancer Reporting Protocols, which the CAP describe as providing "guidelines for collecting the essential data elements for complete reporting of malignant tumors and optimal patient care."[45] In conjunction with its electronic Cancer Checklists (eCCs)[46], pathologists are able to integrate CAP cancer reporting protocols of tumors, resections, and select biopsies into their PIMS' workflow and ensure proper reporting outcomes. Some PIMS vendors (e.g., Orchard Software, LigoLab[24][20]) explicitly indicate their solution integrates CAP's eCC templates and reporting protocols into their solution.
  • annotated organ mapping: In the world of PIMS, organ mapping refers to the concept of placing location-specific diagnostic information from specimen analyses into an anatomical diagram, typically during reporting, to more clearly communicate the results of those analyses. PIMS vendor WebPathLab, Inc. demonstrates this concept well with its Auto Organ Map Module, which not only shows an organ map in the rport but also simplifies data entry for the pathologist using SDE.[47][48] They use the prostate as an example, and explain that "selecting the predetermined number of quadrants in the prostate [diagram], the system autopopulates the specimen description to each corresponding quadrant, and autofills the text for the Gross Description field, leaving only the dimension of each core to be entered by the grosser." NovoPath and Psyche Systems Corporation are additional examples of vendors incorporating organ mapping into their PIMS.[2][39]
  • stain panel and unstained/control slide support: A positive control slide is typically used to qualitatively assess how well a non-hematoxylin-eosin (non-H&E) or "special" stain performs against a gold standard like H&E, and the positive control is usually included with manufactured unstained slides (e.g., see Newcomer Supply's control slide catalog). These slides may be used in histopathology (gauging the manifestation of disease in a tissue) and immunopathology (gauging immune response through visualization of an antibody-antigen interaction in a tissue). In particular, immunopathology and its associated immunohistochemistry may turn to special stain panels, which utilize multiple immunochemical stains to visualize the presence of more than one biomarker expression at the same time.[49][50][51] Vendors like NovoPath and Integrated Business Solutions Group explicitly state their solution supports the management of these types of slides and stain panels.[39][52]
  • grossing support: In medical terms, the adjective "gross" means "visible without the aid of a microscope."[53] By extension, gross examination (i.e., grossing) involves a macroscopic visual assessment of a biospecimen before preparation for microscopy, in order to gleen diagnostic information. Grossing remains a valuable skill used in modern pathology.[54][55] Some PIMS provide a grossing menu for pathologists to scan in and include commentary about a gross examination of a specimen.[20]
  • high-risk patient follow-up: A 2015 study published in Annals of Family Medicine showed evidence that "patients with high clinical complexity and high risk of readmission" benefited from early outpatient follow-up.[56][57] The authors concluded : "Follow-up within seven days was associated with meaningful reductions in readmission risk for patients with multiple chronic conditions and a greater than 20% baseline risk of readmission, a group that represented 24% of discharged patients." Presumably some health care systems are synthesizing that information into their patient workflows, likely through some sort of scheduled event and alert in their primary informatics system, e.g., an electronic health record (EHR) system.[58] Though not common, at least one PIMS vendor—LigoLab, LLC—indicates their solution helps address high-risk patient follow-up, though it's not clear how.[20]
  • research animal support: Non-clinical pathology and toxicology laboratories assisting with research and evaluation studies may be handling non-human specimens or even live research animals. Additional data about these animals, animal groups, and animal tissues may need to be carefully documented as part of a study. As such, some solutions such as Instem's Provantis preclinical pathology solution are designed to record specific animal and group identifiers, animal cross-reference information, organ weight ratios, palpable mass diagnoses, and other attributes for reporting.[59]


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