Forensics & Medical Examiner

Glossary

LabLynx Glossary of Terms

This page is a glossary of terms used in the LabLynx, Inc. Knowledge Base, with links to pages as available.

42 CFR part 493

This part of the US Code of Federal Regulations regulates clinical laboratories specifically. This regulation is administered primarily in the Health Insurance Portability and Accountability Act of 1996 (HIPAA) through the HHS and CMS. It’s important that the LIS support the laboratory’s compliance with [1]. CLIA licensing and compliance fulfills the majority of requirements, along with compliance with HHS/CMS directives and certifications.

API

Application Programming Interface. A language and message format used by an application program to communicate with the operating system or some other control program such as a database management system (DBMS) or communications protocol.[2] HealthCloudPOL interfaces with any other applications, databases or systems if they have one of these. Otherwise, file sharing is used, where one app creates a file somewhere and the other detects it and copies it over. HealthCloudHub is the hardware/software product used to integrate HealthCloudPOL with serial port instruments.

BAA

The Business Associate Agreement. HIPAA requires that any companies conducting business with a HIPAA-regulated entity must sign a BAA that ensures they comply with HIPAA regulations governing such relationships.

CAP

College of American Pathologists. The CAP inspects and accredits medical laboratories under deemed authority of the Centers for Medicare & Medicaid Services (CMS).[3]

Channel

A Channel, as used in relation to WebLIMS.com (and clinical informatics generally), is a bi-directional HL7 interface between a variety of platforms. It is used by the system to link an LIS with EHRs, instruments/devices, agencies, services, etc.

CLIA

The Clinical Laboratory Improvement Amendments of 1988. A United States federal statute and regulatory standards program that applies to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. See CLIA.

CLSI

Clinical and Laboratory Standards Institute. In 1968, 31 clinicians and laboratory scientists representing 15 organizations met to discuss ways of “improving what we are doing for patients” and to develop a formal consensus process for standardization. In 1977, CLSI was accredited by the American National Standards Institute (ANSI) as a voluntary consensus standards organization. At about the same time, CLSI became the home of the National Reference System for the Clinical Laboratory (NRSCL), a collection of broadly understood reference systems intended to improve the comparability of test results, consistent with the needs of medical practice.[4]

CMS

Centers for Medicare and Medicaid Services. The Centers for Medicare & Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (HHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, the State Children’s Health Insurance Program (SCHIP), and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (more commonly referred to as nursing homes) through its survey and certification process, clinical laboratory quality standards under the Clinical Laboratory Improvement Amendments, and oversight of HealthCare.gov.

COLA

Commission on Office Laboratory Accreditation. COLA was founded in 1988 as a private alternative to help laboratories stay in compliance with the new Clinical Laboratory Improvement Amendments (CLIA). In 1993, the Health Care Financing Administration (now CMS) granted COLA deeming authority under CLIA, and in 1997 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) (now called TJC) also recognized COLA’s laboratory accreditation program.[5]

Compatibility Mode

This is a setting in Web Browsers or other software that enables it to be backward-compatible with earlier versions of itself. For instance, in 2015, HealthCloudPOL works best with IE browser versions 8-10, so later versions should be set to “Compatibility Mode”. This is done in the Internet Options/Tools menu usually.

COTS

Commercial, off-the shelf. This refers to the standard template or reference software version that all variations, customizations, etc. for different customers are based upon. It is the original version of the app that is initially provisioned.

DNS

Domain Name System (or Service or Server). All URLs or website addresses are actually numeric IP addresss. The use of letters/words to make them make sense and be memorable for people means these need to be converted so we can type them in the address field of a web browser. DNS services provide this conversion.

EHR

Electronic Health Record. This refers to a system used to contain patient information, including PHI, test results, physician notes, etc. in a physician office, public health or hospital environment. It is often integrated, where possible and reasonable, with an LIS to reduce transcription errors and speed results receipt.

HCFA

HealthCare Financing Administration. See CMS.

Help Desk

The WebLIMS.com Help Desk. All LabLynx, Inc. accounts also are given a Help Desk account, where tickets may be submitted, interactively monitored, approved and closed for setup/implementation items or any additional services or features. Site address and login credentials are assigned upon becoming a LabLynx community member (customer or partner). More at Help Desk.

HHS

The U.S. Department of Health and Human Services. It is the cabinet-level government department that contains the Public Health Service, CDC, FDA, NIH, HRSA and CMS, among many other agencies.[6]

HIPAA

Health Insurance Portability and Accountability Act of 1996. This is a federal law regulating health insurance in the United States, impacting many aspects of clinical processes. In the realm of informatics, its effects fall mainly in the areas of protection of patient information, called “PHI” (Protected Health Information). See HIPAA.

HITECH

The Health Information Technology for Economic and Clinical Health Act. HITECH Act legislation was created in 2009 to stimulate the adoption of electronic health records (EHR) and supporting technology in the United States. [7]

Health Level 7

A set of international technical language standards for transfer of clinical and administrative data between software applications, databases, instruments/devices and other sources or recipients of information used by various healthcare providers.

JCAHO

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO, pronounced “Jay-co”). This is the former name of the current accreditation organization now called simply The Joint Commission (TJC).[8]

LabLynx Cloud Infrastructure

The “Cloud”[9] and “cloud computing” are the latest buzzwords in a longtime move toward storage of information on the Internet rather than on individual hard drives. It means that users don’t have to be in the data center[10] business just to use applications. The LabLynx, Inc. cloud infrastructure is a dedicated, custom-designed network of servers, SANs and related hardware and software housed in secure Tier 4 data centers, connected to additional global networks of the same standards and guaranteeing 100% uptime with full data protection, redundancy, load balancing, failover, backup and security that meet HIPAA, HITECH and all other applicable standards.

LabLynx Community Forums

One of the free benefits of being a LabLynx, Inc. customer is automatic access to its community groups. The Community Forums are online forums where customers can raise issues, discuss shared experiences, etc., regarding general issues or a specific LabLynx industry product.

Laboratory Informatics

Essentially simply the management of laboratory information, today this includes a myriad of aspects including not just instrument results, but also patient or client information (which can be HIPAA-regulated as PHI, or Protected Health Information), historic trends, integrations between systems/databases, instruments, agencies etc.

Laboratory Informatics Institute

The Laboratory Informatics Institute (LII) is a non-governmental organization and “a laboratory industry trade association for the education, standardization and promotion of the functional and professional areas of laboratory informatics.”[11] As well as providing educational resources, the LII also engages in advocacy of the use of laboratory informatics tools and publishes materials related to numerous types of scientific, health, and laboratory informatics. The LII was founded on July 17, 2006 by LabLynx CEO John Jones as an organization and trade association.[11]

LLXQMS

LabLynx Quality Management System – a Quality Management System, or QMS, is a collection of elements instituted within an organization to help ensure a standard of quality. From Wikipedia: “The International Organization for Standardization’s ISO 9001:2008 series describes standards for a QMS addressing the principles and processes surrounding the design, development and delivery of a general product or service. Organizations can participate in a continuing certification process to ISO 9001:2008 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e. planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis (FMEA).”[12] The LabLynx QMS includes a Quality Manual documenting SOPs for business practices, development and other processes, as well as cloud infrastructure management and maintenance, with backups, failure/recovery testing, etc.

LabVia

LabVia is the LabLynx, Inc. hardware/software product that provides multiple integration capabilities between webLIMS and other systems or devices, including EHR/EMRs, instruments, billing services, etc., especially in complex and/or serial-based situations. See LabVia.

Learning Center

A term referring to the section of the LabLynx [website area] that contains all of the online courses made available to LabLynx customers.

LES

A laboratory execution system or LES is a “computer system employed in the laboratory at the analyst work level to aid in step enforcement for laboratory test method execution,” according to the 2007 Annual Book of ASTM Standards.[13] The general purpose of the LES is to direct the user to follow specific steps to ensure the rigidity of the test method and and the process’ end results, though alternate workflow routes may be applied in specific circumstances. The LES may encompass this functionality and more, including tasks like enforcing standard operating procedures (SOPs), validating calculations and instrument interfaces, and acquiring or importing procedural data from other systems into one common system.[14]

LIS

Laboratory Information System – The medical industry version of a LIMS (Laboratory Information Management System – pronounced as a word). The two are essentially the same, with configuration of an LIS focusing on terminology, attention to HIPAA compliance and clinical workflows.

LIMS

Laboratory Information Management System – A laboratory information management system (LIMS) is a software-based laboratory and information management system that offers a set of key features that support a modern laboratory’s operations. The term includes LISs also, but tends to be the term more commonly used in all labs other than clinical (this is slowly changing).

LIMSforum

LIMSforum.com – a laboratory-, medical-, and science informatics-themed web portal community created by the Laboratory Informatics Institute[15] and a community group previously hosted on professional social networking website LikedIn, and later launched as a separate community with added resources such as training courses, apps and less restrictive inter-member communications and information sharing.[16] As of November 2015, the website functions as a web portal with access to a variety of industry content, including scientific and general knowledge, newsletters, blogs, online courses, news, job postings, and a product marketplace.[17]

ONC

The Office of the National Coordinator for Health Information Technology. Part of the U.S. Department of Health and Human Services (HHS), ONC is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information.[18]

PHI

Protected Health Information. This refers to patient information subject to the privacy requirements regulated by HIPAA. See HIPAA.

POL

Physician Office Laboratory. Growing trend where physicians’ offices choose to do certain tests onsite rather than sending out to a reference lab. Most opt for a handful of common tests of low complexity, requiring only a CLIA waiver license. A CLIA waived tests license is cheaper than licensing for CLIA testing, and thus suits physician offices, whose main business is seeing patients rather than testing. However, many POLs decide to purchase one or more major testing instruments like a blood or urine analyzer or more, adding to the number and complexity of the tests they offer. POLs may not, under CLIA rules, offer testing for outside entities (a la reference labs), otherwise they will no longer be classified as a POL and licensing requirements change accordingly. See more at Physician Office Laboratory.

PMS

Practice Management System. System used in physician offices to manage patients, appointments, etc. May also contain test results and/or other information. Where an EHR and/or LIS is used, it can be useful to integrate them.

QTS

The QTS Atlanta Data Center location is the primary site where the LabLynx, Inc. Cloud Infrastructure hosts clients and company sites. An information sheet is available at http://files.mylablynx.com/share/QTSAtlanta.pdf.

SA

The LabLynx, Inc. Sales Agreement.

SaaS

Software as a Service – basically, cloud-hosted software as opposed to software that must be loaded onto an individual computer.

SAN

Storage Area Network. The data storage component of a Cloud Infrastructure.

SiteUptime

All LabLynx Cloud Infrastructure sites are monitored 24/7/365 through SiteUptime monitoring services. Strategic LabLynx Support Team members are instantly alerted should any site not report as up and operational during continual checks at 5-minute intervals.

SSAE 16 SOC 2

American Institute of CPAs’ (AICPA’s) SOC (Service Organization Control) Reports standard for data centers, includes auditing reports which provide “a standard benchmark by which two data center audits can be compared against the same set of criteria”.

Statement on Standards for Attestation Engagements (SSAE) 16 is an auditing standard for service organizations, superseding SAS 70. The latter’s “service auditor’s examination” is replaced by a “Service Organization Controls” (SOC) report. SSAE 16 was issued in April 2010, and became effective in June 2011; many organizations which followed SAS 70 have now shifted to SSAE 16.

SSAE 16 is largely an American standard, but it mirrors ISAE 3402.[19] Similarly SSAE 16 has two different kinds of reports; a SOC 1 Type 1 report is an independent snapshot of the organization’s control landscape on a given day, whilst a SOC 1 type 2 report also adds a historical element, showing that controls were managed over time (typically 6 months).

SSAE 16 reporting can help service organizations comply with Sarbanes Oxley‘s requirement (section 404) to show effective internal controls covering financial reporting.[20] However, it is not limited to financial reporting; it can also be applied to other sectors, and is useful for datacenters in particular.[21]

And within the SOC 2 framework is a comprehensive set of criteria known as the Trust Services Principles TSP) that are composed of the following five (5) sections:

  • The security of a service organization’ system.
  • The availability of a service organization’s system.
  • The processing integrity of a service organization’s system.
  • The confidentiality of the information that the service organization’s system processes or maintains for user entities.
  • The privacy of personal information that the service organization collects, uses, retains, discloses, and disposes of for user entities.

URL

Uniform Resource Locator. Commonly known as a “web address” or “website address”. It’s the address users type into a web browser to access a website.

Web Browser

The computer application that allows users to access the Internet, and acts like a “window” to any web pages visited. These include Microsoft Internet Explorer (IE), Google Chrome, Apple’s Safari and Mozilla’s open source Firefox as by far the most common. As of 2015, the preferred browser for HealthCloudPOL is IE 10 or earlier, or later versions if set to Compatibility Mode. It also works well with Chrome IE emulator extensions.

WebLIMS

WebLIMS is the flagship Laboratory Informatics Management System (LIMS) of LabLynx, Inc., initially known as “ELab” and often simply “LabLynx”. It was initially introduced as the world’s first web browser-based LIMS in 1997, and LabLynx, Inc. was incorporated in 2000 to further develop and market it. It is characterized by offering a wide range of functionality based on configuration rather than having to write code, powered by a stable and robust core laboratory functionality that is universal to all labs. It is currently primarily utilized as a secure cloud-hosted system that vastly reduces time and cost of implementation and maintenance as compared to traditional onsite installs. It is available in pre-configured initial solutions to suit each industry, including clinical/diagnostics, environmental, manufacturing and a host of others. See Industry Solutions.

References

  1. 42 Code of Federal Regulations part 493 – Laboratory Requirements
  2. http://www.pcmag.com/encyclopedia/term/37856/api
  3. en.wikipedia.org/wiki/College_of_American_Pathologists
  4. http://en.wikipedia.org/wiki/Clinical_and_Laboratory_Standards_Institute
  5. http://www.cola.org/about
  6. https://en.wikipedia.org/wiki/United_States_Department_of_Health_and_Human_Services
  7. http://www.limswiki.org/index.php?title=HITECH.
  8. http://http://en.wikipedia.org/wiki/Joint_Commission
  9. http://www.limswiki.org/index.php/Cloud_computing |title=Cloud
  10. http://www.limswiki.org/index.php/Data_center |title=Data center
  11. 11.0 11.1 “Laboratory Informatics Institute Established”. Laboratory Informatics Institute, Inc. 17 July 2006. http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C. Retrieved 12 May 2014. 
  12. “Quality management system”. https://en.wikipedia.org/wiki/Quality_management_system. Retrieved 9 November 2015. 
  13. American Society for Testing and Materials (2007). Annual Book of ASTM Standards 2007. ASTM. p. 296. ISBN 0803142765. http://books.google.com/books?id=znlGAAAAYAAJ&q=%22laboratory+execution+system%22&dq=%22laboratory+execution+system%22&hl=en&sa=X&ei=YKUiUbHrE4O9ywHH_YC4BA&ved=0CDYQ6AEwAA. 
  14. Metrick, Gloria (January 2011). “QA/QC: ELNs Have Come a Long Way”. Scientific Computing 28 (1): 19. http://www.thefreelibrary.com/QA%2FQC%3A+ELNs+have+come+a+long+way%3A+realizing+the+full+potential+of…-a0272245303. Retrieved 18 February 2013. 
  15. “LIMSforum – The Laboratory Informatics Medical & Scientific Professional Community”. Laboratory Informatics Institute, Inc. 27 August 2015. Archived from the original on 31 August 2015. https://web.archive.org/web/20150831220936/http://www.limsforum.com/. Retrieved 31 August 2015. 
  16. “Laboratory, Scientific & Health Informatics Software Download Library added to the Linkedin.com LIMS Forum Group”. Laboratory Informatics Institute, Inc. 12 August 2009. http://www.limsfinder.com/BlogDetail.aspx?id=33719_0_3_0_C. Retrieved 31 August 2015. 
  17. “LIMSforum New Site”. http://www.limsforum.com. Retrieved 1 November 2015. 
  18. http://www.healthit.gov/newsroom/about-onc
  19. “SSAE 16 overview”. http://ssae16.com/SSAE16_overview.html. Retrieved 11 May 2015. 
  20. “SSAE 16 Overview”. Frost. http://www.frostssae16.com/overview/. Retrieved 11 May 2015. 
  21. “Why Data Centers Need SSAE 16”. http://www.datacenterknowledge.com/archives/2011/09/27/why-data-centers-need-ssae-16/. Retrieved 11 May 2015.