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    Lab Guidelines: & Standards

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    Nelson Ariel Sierra Sierra
    The CLSI document AUTO10-A provides guidelines for laboratories to design, implement, validate and customize autoverification rules for clinical laboratory test results based on their patient population needs. It allows laboratories to develop their own rules to reflect their medical views in determining if results should be released or accepted. The guidelines encourage laboratories to automate the interpretation and disposition of most results, which can improve quality, consistency and turnaround time while increasing efficiency and reducing costs. Sysmex America purchased the document to better understand regulatory requirements around autoverification to help with software design, testing and implementation. A laboratory manager intends to use the guidelines to help meet accreditation standards as their laboratory implements a new LIS system with autoverification capabilities

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    Lab Guidelines: & Standards

    Uploaded by

    Nelson Ariel Sierra Sierra
    68 views2 pages
    The CLSI document AUTO10-A provides guidelines for laboratories to design, implement, validate and customize autoverification rules for clinical laboratory test results based on their patient population needs. It allows laboratories to develop their own rules to reflect their medical views in determining if results should be released or accepted. The guidelines encourage laboratories to automate the interpretation and disposition of most results, which can improve quality, consistency and turnaround time while increasing efficiency and reducing costs. Sysmex America purchased the document to better understand regulatory requirements around autoverification to help with software design, testing and implementation. A laboratory manager intends to use the guidelines to help meet accreditation standards as their laboratory implements a new LIS system with autoverification capabilities

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    labmed39-0209

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    The CLSI document AUTO10-A provides guidelines for laboratories to design, implement, validate and customize autoverification rules for clinical laboratory test results based on their patient population needs. It allows laboratories to develop their own rules to reflect their medical views in determining if results should be released or accepted. The guidelines encourage laboratories to automate the interpretation and disposition of most results, which can improve quality, consistency and turnaround time while increasing efficiency and reducing costs. Sysmex America purchased the document to better understand regulatory requirements around autoverification to help with software design, testing and implementation. A laboratory manager intends to use the guidelines to help meet accreditation standards as their laboratory implements a new LIS system with autoverification capabilities

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    68 views2 pages

    Lab Guidelines: & Standards

    Uploaded by

    Nelson Ariel Sierra Sierra
    The CLSI document AUTO10-A provides guidelines for laboratories to design, implement, validate and customize autoverification rules for clinical laboratory test results based on their patient population needs. It allows laboratories to develop their own rules to reflect their medical views in determining if results should be released or accepted. The guidelines encourage laboratories to automate the interpretation and disposition of most results, which can improve quality, consistency and turnaround time while increasing efficiency and reducing costs. Sysmex America purchased the document to better understand regulatory requirements around autoverification to help with software design, testing and implementation. A laboratory manager intends to use the guidelines to help meet accreditation standards as their laboratory implements a new LIS system with autoverification capabilities

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    Lab Guidelines

    & Standards
    Guideline Aims to Improve Autoverification
    Techniques value, laboratory information system [LIS] vendors began to
    DOI: 10.1309/CV5D0L80BWMQLXLV
    offer simpler versions, calling the process ‘autoverification.’
    “Realizing the great potential and improvements that can
    With increasing pressure to maintain adequate turn- be made with autoverification, several of us proposed the cre-

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    around times and to enhance the quality of results, clinical ation of a document on autoverification of clinical laboratory
    laboratories must develop new methods for increasing pro- test results to CLSI,” Dr. Neeley explained. A group of pro-
    ductivity with limited resources. Automated verification, fessionals with different experiences in autoverfication from
    or “autoverification,” has emerged as a tool for laboratories many areas, such as hospitals, reference laboratories, state
    whose goal is to streamline their processes while maintaining organizations, and industries, served on the CLSI committee
    the highest quality standards. charged with developing this guideline, which was published
    The Clinical and Laboratory Standards Institute (CLSI, in October 2006.
    formerly NCCLS) document Autoverification of Clinical Labora-
    tory Test Results; Approved Guideline (AUTO10-A) provides a Mass Appeal
    general framework that allows each laboratory to easily design,
    implement, validate, and customize rules for autoverification According to Dr. Neeley, “AUTO10-A is intended to
    based on its patient population needs. Additionally, supporting provide users with detailed knowledge about the power and
    sections discuss the different aspects of regulatory compliance value of autoverification in improving quality, laboratory
    and validation of algorithms that are essential to establishing efficiency, saving labor, and consistent results.
    and maintaining a modern autoverification system. “Modern autoverification software, either from LIS ven-
    According to William Neeley, MD, FACP, DABCC, dors or in the form of ‘middleware,’ has mass appeal because
    medical director, Detroit Medical Center University Labora- it does not tell the user how to practice modern laboratory
    tories, and chairholder of the CLSI committee that developed medicine, but allows each individual laboratory to develop its
    the document, “AUTO10-A gives the user the tools to develop own rules to reflect its medical views in determining whether
    algorithms or rules based on medical experience, which can be or not results should be released or accepted,” Dr. Neeley
    applied to every result. It’s as if a highly-competent director is said. “Applying these rules evenly throughout the day and
    personally reviewing every result that is coming out of the labo- night provides the highest degree of consistency and accuracy.
    ratory, but it is all done automatically. With modern autoveri- The process provides a high degree of real-time quality assur-
    fication, rules are written into the software so the technologist ance and consistency from one technologist to another.”
    does not have to memorize every idiosyncrasy. It enables one to Every quality laboratory already has a set of well-defined
    practice medicine more easily and consistently.” policies regarding how to interpret and handle most of its
    AUTO10-A is one of a series of 10 CLSI-approved results. “The autoverification guidelines encourage each labo-
    documents that address individual portions of an automated ratory to automate the interpretation and disposition for most
    laboratory system. It is intended for use by information sys- of these problems,” Dr. Neeley explained. “Most results can
    tem vendors; hospital, reference, independent, and physician be handled automatically by computer software. A good au-
    office laboratories; data management vendors; instrument toverification system can be configured to recognize unusual
    manufacturers; and those involved in point-of-care testing. sets of results that it can’t handle. These values are automati-
    cally referred to the supervisor to handle. The end result is
    Filling a Need the production of higher-quality and more-consistent results
    for patients in a shorter time. Simultaneously, overall labora-
    Many laboratory professionals used autoverification for tory efficiency significantly increases and costs decrease.”
    years before the term “autoverification” was coined. “I began
    using personal computers with our software to automatically A Valued Product
    analyze laboratory results,” Dr. Neeley said. “If problems were
    discovered, the results would not be released, and a printed Peter Osella, vice president of regulatory affairs/quality,
    message was provided to the technologist clearly identifying chief compliance officer, Sysmex America, Inc/Sysmex Re-
    the problem and providing a printed solution. We did this in agents America, was prompted to purchase AUTO10-A so his
    chemistry, immunochemistry, hematology, coagulation, and staff could better understand the regulatory requirements the
    urinalysis. This greatly increased productivity. company’s customers face with autoverification of laboratory
    “Other laboratory directors employed similar proce- results. “This standard aids in the company’s software design,
    dures,” Dr. Neeley continued. “We all recognized tremendous testing, and implementation phases,” Osella said.
    benefits, such as reducing errors and providing a more consis- “The document provides a more comprehensive view of how
    tent and thorough review of laboratory results. Because of the customers develop process maps and establish rule algorithms on

    labmedicine.com April 2008 j Volume 39 Number 4 j LABMEDICINE 209


    Lab Guidelines & Standards

    tests targeted for autoverification,” Osella said. “It has helped “I intend to use AUTO10-A as a primary source of verifica-
    us work more closely with laboratories to capture both pre- tion as the LIS system is implemented,” she said. “We employ
    analytic and analytic parameters to assist in rule settings.” CLSI documents to assist us in meeting College of American
    Osella recommends AUTO10-A to other laboratories, Pathologists (CAP) recommendations, and they provide a
    particularly if some of their medical device or middleware quality source of good laboratory practice that is unavailable
    vendors lack awareness of the regulatory and process chal- elsewhere.”
    lenges laboratories face with building and testing autoverifica-
    tion algorithms and rules.
    Of particular interest are Section 5 (regulatory/statutory
    obligations) and Section 6 (validation of algorithms), Osella
    noted. “By understanding these requirements in more detail, Karen Appold is an editorial consultant based in
    we can build some of these critical elements into our product Royersford, PA.
    designs and software verification and validation activities prior CLSI is a global nonprofit organization that promotes
    to release.” the development and use of voluntary consensus standards
    Rhonda Yarbrough, BS, MT(ASCP), laboratory services and guidelines within the health care community.

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    manager, U.S. Medical Center for Federal Prisoners, recently pur-
    chased a new LIS system with the capability of autoverification.

    Cytology Teaser No. 1

    210 LABMEDICINE j Volume 39 Number 4 j April 2008 labmedicine.com

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