LIMSpec for the Physician Office Laboratory - Glossary and Standards

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As an aid to easy use of the Laboratory Informatic Institute's LIMSpec for the Physician Office Laboratory, a glossary of terms used is provided, along with a list of agencies and organizations whose standards apply to POL informatics, and standards and regulations cited on individual specifications.


Glossary

This page is a glossary of terms used in the LIMSpec for the Physician Office Laboratory, with links to other wikis or appropriate sites as available.


A Microsoft service that allows users to use a single sign-on username and password to access multiple things, like an application and the network or LAN on which it is located.


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.[1] An LIS or EHR should be able to interface 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.


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.


Cloud Hosting
The "Cloud" 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 business just to use applications. An example of a high quality cloud hosting infrastructure is a dedicated, custom-designed network of servers, SANs and related hardware and software housed in secure Tier 4 redundant data centers, and guaranteeing 99.9% uptime or better with full data protection and security.


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, the LabLynx POL LIS, HealthCloudPOL works best with IE browser versions 8-10, so later versions should be set to "Compatibility Mode". .


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.


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


A LAN is simply a group of computers linked in a local network. A common example is a home, shop or work wi-fi network.


The medical industry version of a LIMS (Laboratory Information Management System - pronounced as a word).


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


PPM
Provider-Performed Microscopy. This is one of a set of CLIA Test Categories based on complexity. It includes microscopy tests of moderate complexity, often performed along with CLIA-waived tests in many POLs.


RFI

302 Found

302 Found


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Basically, cloud-hosted software as opposed to software that must be loaded onto an individual computer.


SAN
Storage Area Network. A network of high-speed data storage devices used in environments where a large amount of data must be securely and reliably stored, such as a cloud-hosting infrastructure.


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.

Standards Organizations

Established in 1898 originally as the American Society for Testing and Materials, ASTM International is one of the largest voluntary standards developing organizations in the world. ASTM is a not-for-profit organization that provides a forum for the development and publication of international voluntary consensus standards for materials, products, systems and services. ASTM’s members, representing producers, users, consumers, government, and academia from more than 150 countries, develop technical documents that are a basis for manufacturing, management, procurement, codes and regulations. [2]


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


The CDC is a federal agency under the Department of Health and Human Services and is headquartered in unincorporated DeKalb County, Georgia, a few miles northeast of the Atlanta city limits. Its main goal is to protect public health and safety through the control and prevention of disease, injury, and disability.[4]


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.[5]


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.[6]


HCFA
HealthCare Financing Administration. See CMS.


It is the mission of the U.S. Department of Health & Human Services (HHS) to enhance and protect the health and well-being of all Americans. It states that it fulfills that mission by providing for effective health and human services and fostering advances in medicine, public health, and social services.[7]


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]


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.[9]

Standards and Regulations

Section of the United States CFR (Code of Federal Regulations) that pertains to clinical laboratory standards. It was the basis for the CLIA. The section of the federal regulations titled "Standards and Certification: Laboratory Requirements" is issued by the Centers for Medicare & Medicaid Services (CMS) to enact the CLIA law passed by Congress (see below). In general terms, the CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. The final CLIA'88 regulations were first published in 1992, phased in through 1994, and amended in 1993, 1995, and 2003.[10]


This is the listing of all United States federal administrative law. The CFR is divided into 50 titles that represent broad areas subject to federal regulation, with #42 pertaining to public health, and part 493 pertaining to clinical laboratories.


The Clinical Laboratory Improvement Amendments (CLIA) of 1988 is 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.[11]


CLIA Law
The Clinical Laboratory Improvement Amendments of 1988 statute is an amendment to the Public Health Services Act in which Congress revised the federal program for certification and oversight of clinical laboratory testing. Two subsequent amendments were made after 1988. The law continues to be cited as CLIA ’88 as named in legislation.[12]


CLIA-waived testingThese are laboratory tests which have been cleared by the FDA as not being subject to the CLIA regulations for more complex tests. "Waived" is its own CLIA test category, and constitutes the vast majority of tests performed currently in POLs. These are listed on the FDA site. [13]


These are a set of practices (GxP) that apply to (diagnostic) clinical labs that don't do research or trials (those have their own GxP standards).[14]


Specific Good Laboratory Practices for POLS or other locations that do CLIA-waived testing have been drawn up by the CLIA Committee and are available from the CDC.[15]


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. See http://www.limswiki.org/index.php?title=HITECH.


HL7
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.


A LIMSpec is a set of standard specifications for a laboratory data management system of some kind (including LIS, LIMS, SDMS, Lab Notebook, ELN, etc.) used to compare systems. The LIMSpec standards of assessment system was developed by the Laboratory Informatics Institute.


LOINC
The Logical Observation Identifiers Names and Codes is a common language (set of identifiers, names, and codes) for clinical and laboratory observations. Any LIS or lab data management system should support it.[16]


Meaningful use sets specific objectives that eligible professionals (EPs) and hospitals must achieve to qualify for Centers for Medicare & Medicaid Services (CMS) Incentive Programs. They are rolled out in three phases, 1-3, with Stage 1 in 2011-2012, Stage 2 in 2014 and Stage 3 in 2016.[17]


The Public Health Information Network is a CDC national initiative to increase the capacity of public health agencies to electronically exchange data and information across organizations and jurisdictions (e.g., clinical care to public health, public health to public health and public health to other federal agencies).[18]


Currently used variation is SNOMED - CT, or Systematized Nomenclature of Medicine - Clinical Terms. SNOMED CT is an extensive clinical terminology that was formed by the merger, expansion, and restructuring of SNOMED RT® (Reference Terminology) and the United Kingdom National Health Service (NHS) Clinical Terms (also known as the Read Codes). It is the most comprehensive clinical vocabulary available in English (or any language). SNOMED CT is concept-oriented and has an advanced structure that meets most accepted criteria for a well-formed, machine-readable terminology. It has been designated as a US standard for electronic health information exchange in Interoperability Specifications produced by the Healthcare Information Technology Standards Panel and has also been adopted for use by the US Federal Government, through the Consolidated Health Informatics (CHI) Initiative, for several clinical domains.[19]


Statement on Standards for Attestation Engagements No. 16, Reporting on Controls at a Service Organization, was finalized by the Auditing Standards Board of the American Institute of Certified Public Accountants (AICPA) in January 2010. SSAE 16 effectively replaces SAS 70 as the authoritative guidance for reporting on service organizations. SSAE 16 was formally issued in April 2010 and became effective on June 15, 2011. It is the main standard usually looked for when selecting a data center to house applications and data.[20]

References

  1. http://www.pcmag.com/encyclopedia/term/37856/api
  2. http://www.astm.org/ABOUT/faqs.html
  3. en.wikipedia.org/wiki/College_of_American_Pathologists
  4. https://en.wikipedia.org/wiki/Centers_for_Disease_Control_and_Prevention#cite_note-31
  5. http://en.wikipedia.org/wiki/Clinical_and_Laboratory_Standards_Institute
  6. http://www.cola.org/about
  7. http://www.hhs.gov/about/index.html
  8. http://http://en.wikipedia.org/wiki/Joint_Commission
  9. http://www.healthit.gov/newsroom/about-onc
  10. "42 CFR 493 - LABORATORY REQUIREMENTS". US Government Publishing Office. http://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html. Retrieved 5 Aug 2015. 
  11. http://www.limswiki.org/index.php/CLIA
  12. http://www.gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf
  13. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm
  14. http://www.who.int/tdr/publications/documents/gclp-web.pdf
  15. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5413a1.htm
  16. https://loinc.org/background
  17. http://www.healthit.gov/providers-professionals/meaningful-use-definition-objectives
  18. http://www.cdc.gov/phin/about/index.html
  19. http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html
  20. http://ssae16.com/SSAE16_overview.html