Book:Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research/Resources for selecting and implementing informatics solutions: Part 3: Industry and community resources/Standards, regulations, and guidance

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5.5 Standards, regulations, and guidance

The following represent some of the major instances of standards, regulations, and guidance documents affecting how medical diagnostic and research laboratories should operate. This collection doesn't represent every possibility but covers most of the significant options. In a few cases (e.g., the CLSI), there were too many items to list, and a link to the associated items was included instead.

Accreditation requirements

Accreditation requirement Description Relevant medical or research field(s) AAVLD Requirements for an AVMDL the laboratory accreditation requirements for the American Association of Veterinary Laboratory Diagnosticians Veterinary medicine ABFT Accreditation Manual the laboratory accreditation requirements for the American Board of Forensic Toxicology Forensic medicine - toxicology AIHA-LAP Policies 2021 the laboratory accreditation requirements for the American Industrial Hygiene Association Microbiology - environmental ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories the laboratory accreditation requirements for the American Society of Crime Laboratory Directors / Laboratory Accreditation Board; NOTE: ASCLD/LAB has since merged with the ANSI National Accreditation Board (ANAB) Forensic medicine COLA Laboratory Accreditation Standards the laboratory accreditation requirements of the Commission on Office Laboratory Accreditation See description JCI Laboratory Accreditation Standards the laboratory accreditation requirements for the Joint Commission International; applicable to microbiology, clinical chemistry, hematology, blood banking and transfusion, cytogentics, and immunology/serology labs See description NYS Department of Health - Clinical Laboratory Evaluation Program the laboratory accreditation requirements for New York State's "clinical laboratories and blood banks, including out-of-state facilities that accept clinical specimens collected in New York State" See description

Guidelines and recommendations

Guideline/Recommendation Description Relevant medical or research field(s) ACMG Standards and Guidelines for Clinical Genetics Laboratories guidelines from the American College of Medical Genetics on the laboratory "use of molecular techniques to examine heritable changes in the human genome"; a more recent version (2014) exists but may only be available to ACMG members Genetic diagnostics APHL Clinical Laboratory Preparedness and Response Guide guidelines from the Association of Public Health Laboratories and the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety Any ASM Sentinel Level Clinical Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases guidelines from the American Society for Microbiology on clinical (and any other) laboratories handling microorganisms and toxins of elevated risk to human health and public safety Any CDC Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories guidelines from the Centers for Disease Control and Prevention on biosafety practices in clinical diagnostic laboratories working with human and animal specimens Any CDC PHIN Messaging System guidelines from the Centers for Disease Control and Prevention on using the Public Health Information Network Messaging System Public health DAIDS Guidelines for Good Clinical Laboratory Practice Standards GLP guidelines from the NIH's Division of AIDS (DAIDS) for clinical research laboratories conducting testing that supports a clinical trial sponsored by DAIDS Clinical research ICAR 15 Data Exchange guidelines from the International Committee for Animal Recording for data management and transfer of animal data; though rare, may apply to the occasional veterinary laboratory Veterinary medicine NIST 800-53, Rev. 4 recommendations in the form of information security and privacy controls from the National Institute of Standards and Technology; these cybersecurity controls apply to federal systems, though they can be applied to non-federal systems just as readily Any WHO Good Clinical Laboratory Practice guidelines from the World Health Organization (WHO) for organizations performing testing for clinical trials as part of good clinical practice Clinical research

Regulations and legal requirements

Regulation or legal requirement Description Relevant medical or research field(s) 5 CFR Part 930.301 U.S. Code of Federal Regulation 5 CFR § 930.301 Information systems security awareness training program; this would affect medical diagnostic and research laboratories housed in executive agencies of the U.S. government, e.g., National Institutes of Health and Federal Bureau of Investigation See description 9 CFR Part 121 U.S. Code of Federal Regulation 9 CFR § 121 Possession, Use, and Transfer of Select Agents and Toxins; this would affect medical diagnostic and research laboratories interacting with specific biological agents and toxins that pose a threat to public and animal health and safety See description 18 U.S. Code Part 220 aka EKRA 18 U.S. Code § 220 Illegal remunerations for referrals to recovery homes, clinical treatment facilities, and laboratories; aka EKRA, this affects all laboratories and their sales and contracting activities, prohibiting kickbacks and payments based on number of referrals or tests, or the amount billed (and yes, this is getting prosecuted) Any 21 CFR Part 11 U.S. Code of Federal Regulation 21 CFR § 11 Electronic Records and Signatures; this would affect medical diagnostic and research laboratories of all types interacting with electronic records Any 21 CFR Part 606 U.S. Code of Federal Regulation 21 CFR § 606 Current Good Manufacturing Practice for Blood and Blood Components; this would affect medical laboratories collecting, processing, testing, storing, and distributing blood and blood components Blood banking and transfusion medicine 21 CFR Part 812 U.S. Code of Federal Regulation 21 CFR § 812 Investigational Device Exemptions; this would affect central and contract research laboratories conducting clinical investigations of medical devices Clinical research 29 CFR Part 1910.1030 U.S. Code of Federal Regulation 29 CFR § 1910.1030 Bloodborne pathogens; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to blood or other potentially infectious materials See description 29 CFR Part 1910.1096 U.S. Code of Federal Regulation 29 CFR § 1910.1096 Ionizing radiation; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to ionizing radiation sources such as x-rays, CT or CAT scans, PET scans, fluoroscopy, or any nuclear medicine procedures See description 29 CFR Part 1910.1200 U.S. Code of Federal Regulation 29 CFR § 1910.1200 Hazard communication; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper notification of the hazards the chemicals pose See description 29 CFR Part 1910.1450 U.S. Code of Federal Regulation 29 CFR § 1910.1450 Occupational exposure to hazardous chemicals in laboratories; this would affect medical diagnostic and research laboratories of all types that have occupational exposure risk to hazardous chemicals, requiring proper procedures and record-keeping related to workplace chemicals See description 42 CFR Part 73 U.S. Code of Federal Regulation 42 CFR § 73 Select Agents and Toxins; this would affect medical diagnostic and research laboratories "that possess SARS-CoV, Lujo virus, or Chapare virus" See description 42 CFR Part 493 aka CLIA Regulations U.S. Code of Federal Regulation 42 CFR § 493 Laboratory Requirements aka CLIA Regulations; this would affect all medical diagnostic laboratories and apply to select medical research laboratories See description 45 CFR Part 160 aka HIPAA Regulations U.S. Code of Federal Regulation 45 CFR § 160 General Administrative Requirements aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory "who transmits any health information in electronic form" See description 45 CFR Part 164 aka HIPAA Regulations U.S. Code of Federal Regulation 45 CFR § 164 Security and Privacy aka HIPAA Regulations; this would affect any medical diagnostic and research laboratory "who transmits any health information in electronic form" See description CJIS Security Policy U.S. Department of Justice's Criminal Justice Information Services Security Policy; this mandates the provision of "appropriate controls to protect the full life cycle of Criminal Justice Information" for "all entities with access to, or who operate in support of, FBI CJIS Division’s services and information" Forensic medicine (see description) U.S. state-specific laboratory licensing regulations an online U.S. state licensing map by Lighthouse Lab Services which links to state-specific licensing requirements and laws Any

Standards and specifications

Though not listed below, the Clinical and Laboratory Standards Institute (CLSI) has a mountain of standards for laboratories (though pricey). There are too many to list here, so see their standards repository on their website. Similarly, ASTM International has many other informatics standards that may apply to laboratories. See their Committee E13 on Molecular Spectroscopy and Separation Science and Committee E31 on Healthcare Informatics for more standards.

Standard or specification Description Relevant medical or research field(s) ASTM E1188-11 ASTM International's ASTM E1188-11 Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator; describes best practices for the "collection and preservation of evidence for further analysis" Forensic medicine ASTM E1459-13 ASTM International's ASTM E1459-13 Standard Guide for Physical Evidence Labeling and Related Documentation; describes best practices for managing chain of custody for physical evidence Forensic medicine ASTM E1492-11 ASTM International's ASTM E1492-11 Standard Practice for Receiving, Documenting, Storing, and Retrieving Evidence in a Forensic Science Laboratory; describes best practices for physical evidence management in order to protect the chain of custody for the evidence Forensic medicine ASTM E1578-18 ASTM International's ASTM E1578-18 Standard Guide for Laboratory Informatics; provides educational guidance on the many aspects of laboratory informatics, including "issues commonly encountered at all stages in the life cycle" of such systems Any DICOM Standard the National Electrical Manufacturers Association's (NEMA) Digital Imaging and Communications in Medicine (DICOM) standard "to transmit, store, retrieve, print, process, and display medical imaging information" Various ICD-10 and 11 Standard the World Health Organization's (WHO) International Statistical Classification of Diseases and Related Health Problems (ICD) standard for reporting diseases and health conditions; ICD-11 goes into effect 01 January 2022 Various ISO 15189:2012 International Organization for Standardization's ISO 15189:2012 Medical laboratories — Requirements for quality and competence; this standard "specifies requirements for quality and competence in medical laboratories" and is used for developing quality management systems and confirming laboratory competency Any ISO/IEC 17025:2017 International Organization for Standardization's ISO 17025:2017 General requirements for the competence of testing and calibration laboratories; this standard "specifies the general requirements for the competence, impartiality and consistent operation of laboratories" and is used for assuaging others to the competence of the lab Any LOINC Standard the Regenstrief Institute's Logical Observation Identifiers Names and Codes (LOINC) standard, "a common language (a set of identifiers, names, and codes) for identifying health measurements, observations, and documents" Various NAHLN HL7 Messaging Quick User Guide The Veterinary Terminology Services Laboratory, part of the Virginia-Maryland Regional College of Veterinary Medicine, and its National Animal Health Laboratory Network (NAHLN) HL7 Messaging standards; this user guide provides the participating veterinary laboratory assistance on using the HL7 messaging protocol and NAHLN standards in order to transmit data Veterinary medicine NYS Department of Health Clinical Laboratory Standards of Practice The New York State Department of Health, Wadsworth Center's Clinical Laboratory Standards of Practice; this is a two-part collection of laboratory standards for NYS labs and those non-NYS labs that handle specimens originating in NYS, though these standards could effectively be applied by any medical laboratory; includes standards for specialty laboratories Any SNOMED CT SNOMED International's Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) standard, for standardized medical terminology Various U.S. National Library of Medicine UMLS the Unified Medical Language System (UMLS), which "integrates and distributes key terminology, classification and coding standards, and associated resources to promote creation of more effective and interoperable biomedical information systems and services" Various VeNom Coding Group terminology VeNom Coding Group's VeNom Veterinary Nomenclature; this is a standardized veterinary terminology "for use in referral veterinary hospital electronic patient records and first opinion veterinary practice management systems" Veterinary medicine Veterinary Terminology Services Laboratory terminology options The Veterinary Terminology Services Laboratory (VTSL), part of the Virginia-Maryland Regional College of Veterinary Medicine, and its standardized terminology resources; the VTSL maintains a variety of standardized veterinary terminologies, including "the Veterinary Extension to SNOMED CT as well as subsets for the National Animal Health Laboratory Network, AAHA Diagnostic Terms and AAEP Diagnostic Terms" Veterinary medicine