The Clinical Informatics Resource Guide highlights resources that provide awareness and understanding of clinical informatics topics.

Clinical Informatics Resource Guide

VERSION 1.2.0.0 | ISSUE NO. 1 | 2018

Opinions expressed in this document are the authors’ own and do not necessarily reflect an endorsement by the CAP of any organization, equipment, reagents, materials, or services used by participating laboratories.

© 2018 College of American Pathologists. All rights reserved. None of the contents of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without the prior written permission of the publisher.

Table of Contents What is Clinical Informatics? 

Goals of this Resource Guide and How to Use It? 

What is the Clinial Informatics Resource Guide? 

How to Use This Clinical Informatics Resource Guide 

Versioning of the Clinical Informatics Resource Guide 

Clinical Informatics Resource Guide Revision Summary 

Editors and Contributors of the Clinical Informatics Resource Guide 

Section 1: Clinical Informatics - The Basics 

1.1 Overview 

1.2 What is Clinical Informatics and why is it important to me? 

1.3 How is Clinical Informatics different from Information Technology? 

Section 2: Understanding Information Technology Fundamentals 

2.1 The Basics 

2.1.1 What is an intranet? 

2.1.2 What is encryption? 

2.1.3 What is open source? 

2.1.4 What is HL7 and how does it relate to interfaces? 

2.1.5 What is Integrating the Healthcare Enterprise (IHE) and how does it relate to the laboratory? 

2.2 VPNs and Authentications 

2.3 Specimen Identification and Tracking Technologies 

2.3.1 What are the pros and cons of 1D and 2D bar coding? 

2.3.2 What are the differences, advantages and disadvantages of using RFID versus barcoding? 

2.3.3 How can barcodes and RFID be utilized in the Anatomic Pathology or Biorepository laboratory? 

2.3.4 How can barcodes and RFID be utilized in Transfusion Medicine, and are there additional uses for barcode and RFID technology within the laboratory? 

2.3.5 Insights from Adopters – Liron Pantanowitz, MD, FCAP 

2.3.6 Insights from Adopters – R. Ross Reichard, MD, FCAP 

2.3.7 Biometrics and Positive Patient Identification 

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2.3.8 Insights from Adopters – Raymond Aller, MD, FCAP

Section 3: Understanding Laboratory Data Structures and Information Exchange 

3.1 Vocabularies 

3.1.1 LOINC - What is it and why do I need it? 

3.1.2 SNOMED CT-What are the uses for this in my laboratory results? 

3.1.3 What do I need to know about the Dublin Core and Common Data Elements? 

3.1.4 What is UCUM (and why do I care)? Why is UCUM important? 

3.1.5 Are there guides I can use for implementing LOINC and SNOMED CT in my laboratory? 

3.1.6 Insights from Adopters – Alexis Byrne Carter, MD, FCAP 

3.2 Reporting Standards 

3.2.1 What is free-text versus structured reporting? 

3.2.2 What is cCDA and how is it used? 

3.3 Using Data for Purposes Beyond Reporting the Result 

3.3.1 How do I use my LIS to get performance metrics? (e.g. TAT) 

3.3.2 How can I use the data in my LIS to improve patient care? 

3.4 What is the CMS Medicare’s Quality Payment Program (QPP)? 

3.4.1 Insights from Adopters – Walter H. Henricks, MD, FCAP 

Section 4: Selecting and Installing a Laboratory Information System 

4.1 Selection and Purchasing Process 

4.1.1 How do I evaluate LISs, evaluate my needs, and write an RFP to determine the best LIS for an institution? 

4.1.2 Should I choose a stand-alone LIS or lab modules incorporated into the EHR? 

4.1.3 What are the performance and regulatory issues I need to be aware of when selecting a new LIS, and what things do I need to consider so that my new system will remain usable for many years? 

4.1.4 Insights from Adopters – John Sinard, MD, PhD, FCAP 

4.1.5 Insights from Adopters – Alexis Byrne Carter, MD, FCAP 

4.1.6 Insights from Adopters – Rajesh Dash, MD, FCAP and Alexis Byrne Carter, MD, FCAP 

4.2 Installation Process and Vendor Collaboration 

4.2.1 How do I assess current and future workflows and why is it important? 

4.2.2 What factors should be considered and what is involved to purchase / add / bring a new analyzer LIVE and on-line? 

4.3 Validation and Documentation Considerations 

4.3.1 How do I validate my LIS and what are the different types of testing used

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in LIS implementations? (unit, integration, parallel, post-go-live) 

4.3.2 How do I validate my specialty systems such as Digital Pathology, Whole Slide Imaging, and Next Generation Sequencing? 

4.3.3 How do I develop downtime processes and manage downtime in both planned and unplanned situations? 

4.3.4 What procedure manuals for LIS are required? 

4.3.5 What should I know about Informatics and Laboratory Developed Tests (LDTs)? 

4.4 Insights from Adopters – Mark Routbort, MD, PhD, FCAP 

Section 5: Integration and Management of Information Systems 

5.1 Interfaces and Middleware 

5.1.1 What are interfaces and middleware? 

5.1.2 How does my LIS interface with multiple EHRs? 

5.1.3 How does an LIS incorporate send-outs? 

5.1.4 How do I handle the electronic orders and results in an outreach setting? 

5.1.5 Are any implementation guides available from HL7 that provide interoperability standards for use with orders and results interfaces? 

5.1.6 What is auto-verification and how do I get it implemented? 

5.1.7 What is a synthesized and/or integrated (composite) disease report and how can I link to other systems? 

5.1.8 Will the reporting specialties—pathology and radiology-- join forces? Why would they? 

5.2 Managing the Test Compendium 

5.2.1 How do I change a test and test definition in my test compendium? 

5.3 Managing Test Patients 

5.3.1 What are the best practices for test patients in the system? 

5.3.2 What are the best practices for PT testing? 

5.3.3 How do I avoid PT being labeled as a referral? 

5.4 Clinical Decision Rules 

5.4.1 What clinical decision rules can the lab develop? 

5.5 Patient Portals 

5.5.1 What are patient portals and what are the requirements to access lab tests? 

Section 6: Accreditation and Regulatory Aspects of Information Systems 

6.1 What are the CLIA and LAP Accreditation Requirements? 

6.1.1 How do I maintain my computer facility, and what do I have to do if it is remote to my facility? 

6.1.2 What is the first downstream reporting system? 

6.1.3 How do I handle downtime for my electronic systems? 

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6.1.4 What are the regulatory requirements to implement autoverification?

6.2 Insights from Adopters – William Castellani, MD, FCAP 

6.3 Outsource Storage and the Cloud 

6.3.1 What exactly is cloud computing? 

6.3.2 What are the existing standards relevant to cloud computing? 

6.3.3 Are virtualization and cloud computing the same? 

6.3.4 Are there security guidelines specific for clinical laboratories using cloud application for in vitro diagnostic systems? 

6.3.5 What are the options for protecting privacy in cloud computing services? 

6.3.6 What concerns exist for outsourcing portions of organizational computing services to a public cloud? 

6.3.7 What legal issues and topics should be addressed in cloud computing contracts? 

6.3.8 How does “big data” relate to cloud computing? 

Section 7: Biobanking and Biorepositories 

7.1 Software Applications for Quality Biobanking 

7.2 Managing a Biobank 

7.3 Quality, Standards and Proficiency Testing 

7.4 Preanalytic Variables 

7.5 Integrating Biobanking Data into the practice of Medicine 

Section 8: Big Data and Metadata 

8.1 Big Data/Metadata 

8.1.1 What is metadata and what is its value? 

8.1.2 What is “big data” and what are its implications in my practice? 

8.1.3 Insights from Adopters – Ramy Arnaout, MD, DPhil, FCAP 

8.1.4 What is the role of precision medicine in cancer? 

8.1.5 What are the data sources for genomics? What are the challenges for capturing, storing and analyzing this information? 

8.1.6 Insights from Adopters – Philip C. Chen, MD, PhD, FCAP 

8.2 Cost Implications 

8.2.1 How can I view financial data from my institution to calculate downstream costs for what the laboratory does? 

8.2.2 What do I bring to the table that is valuable? 

8.3 The Value of Big Data in the Laboratory and in Value Based Care 

8.4 Insights from Adopters – Philip C. Chen, MD, PhD, FCAP 

8.5 Value of Informatics in the Laboratory 

8.5.1 How can I use informatics to determine cost-effectiveness and to better allocate resources? 

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Section 9: Futurematics 

9.1 Computational Pathology 

9.1.1 Anatomic Pathology 

9.1.2 Clinical Pathology 

9.1.3 Vision Statements 

9.2 Artificial Intelligence (AI) 

9.2.1 Tools 

9.2.2 Data Mining in Free Text 

9.2.3 Text Mining 

9.2.4 AI in Pathology Imaging 

9.3 Blockchain 

9.3.1 Blockchain in Healthcare Information Exchange (HIE) 

9.3.2 Blockchain in Population Health Research 

9.3.3 Blockchain in Interoperability 

9.4 Insights from Adopters – James Harrison, MD, PhD, FCAP 

Section 10: CAP Resources 

10.1 CAP Resource Guides 

10.2 CAP Cancer Protocols 

10.3 CAP Electronic Cancer Checklists (eCC) 

10.4 CAP LAP: Accreditation 

10.5 CAP’s Short Presentations on Emerging Concepts (SPECs) 

Section 11: CAP Clinical Informatics Educational Resources 

11.1 CAP Webinars 

11.1.1 Hot Topics in Pathology Webinars in 2017 and 2018 

11.1.2 Archived Non-CME Clinical Informatics Webinars 

11.2 CAP Annual Meeting 

11.3 CAP Education Resources 

11.4 Pathology Informatics Education for Residents (PIER) 

Section 12: Feedback 

How to Cite This Document 

Clinical Informatics Resource Guide Contributors 

Bibliography 

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