Pathology Informatics Standards and Web Resources

Welcome to the API's Standards and Resource Links page. We hope you will find it useful. Please send suggestions for new links and new content, as well as corrections and other comments to the API Administrative office.

Data Interchange Standards for Pathology and Health Care

HL7: Health Level Seven (HL7 see link "What is HL7?") is an ANSI-accredited health care standards development organization founded in the mid-1980s to promote messaging standards for clinical and administrative data, including LIS to HIS messaging standards. HL7 currently sponsors a broad range of standardization activities including the HL7 Version 3 Reference Information Model (RIM) and the HL7 Clinical Document Architecture (CDA). An updated CDA specification has recently been published.
LOINC®: Logical Observation Identifiers Names and Codes: A volunteer standards development activity at Regenstrief Institute for Health Care that provides a standard set of universal names and codes for identifying laboratory and clinical results. LOINC codes allow clinical results from many sources to be more readily merged for patient care, research or management use. The LOINC database currently contains about 32,000 terms, of which nearly 20,000 relate to laboratory testing.
DICOM: (Digital Imaging and COmmunications in Medicine) A standard developed by the American College of Radiology and the National Electrical Manufacturer's Association (ACR-NEMA) for communications between medical imaging devices. DICOM conforms to the ISO reference model for network communications and incorporates object-oriented design concepts. [From FOLDOC] More DICOM links can be found here.
ASTM: The American Society for Testing Materials E31 Committee's laboratory instrument interface standards are now listed as historical or withdrawn and are superceded by equivalent standards maintained by the National Committee on Clinical Laboratory Standards (NCCLS) that are available from the American National Standards Institute (ANSI)
IEEE 1073: The Institute of Electrical and Electronic Engineers IEEE 1073 Standard for Medical Device Communications (also sometimes called the Medical Information Bus or MIB) is a data communications standard for bedside patient connected devices. IEEE 1073 and the equivalent ISO 11073 have been accepted as a federal standard for point-of-care devices. IEEE 1073 is not used for laboratory instrument interfaces.
Other: International site with downloadable instrument interface software that may be used at no cost for non-commercial purposes.

eXtensible Markup Language (XML)

XML now serves as the conceptual and notational framework for all modern data interchange standards, structured documents, and the still-evolving world of "web services." The World Wide Web Consortium (W3C) is the official custodian of XML specifications, guidelines, software, and tools; and there are useful resources sites and tutorials at www.xml.com/? www.w3schools.com/ and www.xmlfiles.com/xml/

Pathology Reports and Structured Data in Pathology

The Association of Directors of Anatomic and Surgical Pathology (ADASP) describe The Standardization of the Surgical Pathology Report, and the CAP Laboratory Accreditation Checklists define additional requirements for computer-based pathology and laboratory reports. Synoptic reports in pathology are discussed extensively in the pathology literature (PubMed) and in a recent article in CAP Today. The CAP's protocols for cancer reporting are discussed in CAP Today, and CAP templates for tumor reporting are now available from SNOMED. Other useful resources include the Berman/Edgerton/Friedman article on TMA data structure ("The tissue microarray data exchange specification: a community-based, open source tool for sharing tissue microarray data."), and David Booker's presentations at APIII.

Regulation and Accreditation

CLIA: The Centers for Disease Control and Prevention (CDC) has a Clinical Laboratories Improvement Act page with a table of contents for the subparts of the regulations.?? The definitive CLIA document is from the Federal Register and is called the 2003 codification, and the official document can? be found at the Government Printing Office. CMS also maintains a CLIA site with guidelines and other materials. The requirements for laboratory reports are here.
CAP: The College of American Pathologists' (CAP) Laboratory Accreditation Checklists include questions regarding the LIS in the "Laboratory General" section.
HIPAA: The Centers for Medicare and Medicaid Services (CMS) has a "HIPAA home page" with related links including an FAQ, guidelines and others. The Privacy Rule and the Security Rule are available in multiple formats. There is additional information about the Privacy Rule is available at the HHS Office for Civil Rights, and the NIH has published information for researchers and requirements for research databases about the Privacy Rule.? The National Institute of Standards and Technology (NIST) has just published an Introductory Guide for Implementing the HIPAA Security Rule (NIST Special Publication 800-66) that "summarizes the HIPAA security standards and explains some of the structure and organization of the Security Rule. This SP helps educate readers about security terms used in the HIPAA Security Rule and to improve understanding of the meaning of the security safeguards set out in the Rule. This publication is also designed to direct readers to helpful information in other National Institute of Standards and Technology (NIST) publications on individual topics the HIPAA Security Rule addresses. Readers can draw upon these publications for consideration in implementing the Security Rule."
FDA: The Food and Drug Administration (FDA) regulates software that is part of medical devices, and software that is used by "blood establishments." FDA software regulation sites: General Principles of Software Validation: Final Guidance for Industry and FDA Staff: 2002 and FDA Blood Band Inspection Guide (includes computerization).
JCAHO: The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accredits health care organizations, including laboratories.
ISO 15189: An international laboratory standard of limited interest in the United States.

CAP Today LIS Review Series

Laboratory Information Systems (LIS) http://www.cap.org/apps/docs/cap_today/surveys/1103_LISsurvey.pdf
http://www.cap.org/apps/docs/cap_today/surveys/1101_lis.pdf
POL links
http://www.cap.org/apps/docs/cap_today/surveys/0203_SRSlinking.pdf
AP systems
http://www.cap.org/apps/docs/cap_today/surveys/0204_AP_Survey.PDF
http://www.cap.org/apps/docs/cap_today/surveys/0303_ap.pdf
http://www.cap.org/apps/docs/cap_today/surveys/0202_ap.pdf
Blood Bank Systems
http://www.cap.org/apps/docs/cap_today/surveys/1001_BloodBank.pdf

Other Laboratory Information System (LIS) Resources

LIS sites (e.g., http://www.limsource.com/products/lis/lisalpha.html
Patient record linking - datamining.anu.edu.au/projects/linkage.html
Manuals for old computer terminals: http://www.vt100.net/
PDA Standards for laboratory data: Hopkins document

11/17/2008