Harmonization of critical values across the GTA hospitals

Critical values aid in the interpretation of patient test results.

Harmonization of critical values used by hospitals and their associated clinical laboratories across the GTA is essential to ensure consistency in the definition and identification of 'critical state' patients.

To assess the feasibility for harmonization of critical values across GTA, we are surveying Laboratory Medicine departments of hospitals in areas of:

  • Genetics
  • Chemistry
  • Hematology
  • Pathology

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Latest guidelines from the Harmonization of critical values working group

Biochemistry and Haematology Critical Values Policies Across the GTA

Harmonization of critical values
Jun 28, 2022

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This document summarizes our survey findings for policies and thresholds relating to critical values from hospitals within the Greater Toronto Area. This initial assessment into current critical values practices and thresholds will serve as a foundation for consensus recommendations related to critical values for clinical laboratories.

Laboratories Policies Survey: key findings

All surveyed institutions follow a similar framework with regards to critical values policies:

  • There is a defined list of tests that warrant having critical value(s) in place in consultation with clinical stakeholders
  • Critical results are primarily flagged/identified by the Laboratory Information System (LIS)
  • Laboratory staff are primarily responsible for immediate communication of critical values
  • The minimum information to be communicated to clinical staff includes test name, test result and patient name, all of which must be read back to laboratory staff
  • There is documentation of critical value communication primarily within the LIS

There is opportunity for improvement with respect to auditing and quality management for critical values systems across all institutions

  • The frequency and stakeholders involved with periodic audits of critical values is not well-defined across institutions
  • Few laboratories monitor quality indicators/measures such as:
    • Time elapsed between identification and receipt of critical results
    • Critical results flagging rates 

Critical Values Survey: key findings

Across 16 participating institutions, we identified a total of 93 tests within Biochemistry and Haematology/Coagulation with critical values - see the downloadable PDF for a full list of tests.

Of note, there was considerable variability for population-specific critical values across institutions.

  • Characteristics used to define a specific population included: sample type, age, inpatient/outpatient status, anticoagulant status

The following tests are likely to be “harmonizable” with respect to critical values within the GTA as they displayed the least variability across institutions:

Low Critical Value

  • pCO
  • pO
  • Glucose
  • Magnesium
  • Osmolality
  • Sodium
  • Fibrinogen
  • Neutrophils

High Critical Value

  • pCO
  • Bicarbonate
  • Calcium, total
  • Calcium, ionized
  • Osmolality
  • Phosphate
  • Hemoglobin
  • INR
  • Platelets
  • Gentamicin, pre-dose
  • Phenobarbital
  • Theophylline
  • Tobramycin, pre-dose
  • Vancomycin, pre-dose

Summary and recommendations

This initial assessment into current critical values practices and thresholds has identified commonalities and differences across GTA hospitals. Although it is premature to provide recommendations on the “appropriate” critical values policies, these findings will serve as a foundation for subsequent consensus building with key stakeholders.

The ultimate goal will be to develop and disseminate standardized critical values policies wherever appropriate and possible for the GTA.

Authors / contact

Compiled by

Dr. Felix Leung

Assistant Professor, Department of Laboratory Medicine & Pathobiology, University of Toronto, Clinical Biochemist, Mount Sinai Hospital

felix.leung@sinaihealth.ca

Contributors

Dr. Saranya K. Arnoldo
Assistant Professor, Department of Laboratory Medicine & Pathobiology, University of Toronto
Clinical Biochemist, William Osler Health System

saranya.arnoldo@williamoslerhs.ca

Dr. Daniel R. Beriault
Assistant Professor, Department of Laboratory Medicine & Pathobiology, University of Toronto
Head of Biochemistry, Unity Health Toronto

Daniel.Beriault@unityhealth.to

Dr. Davor Brinc
Assistant Professor, Department of Laboratory Medicine & Pathobiology, University of Toronto
Clinical Chemist, University Health Network

davor.brinc@uhn.ca

Dr. Paul Yip
Associate Professor, Department of Laboratory Medicine and Pathobiology, Sunnybrook Health Science Centre and University of Toronto

paul.yip@utoronto.ca

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Defining and reporting on critical values in genetics

Harmonization of critical values
Feb 8, 2022

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As part of an initiative to harmonize critical value reporting across genetic laboratories in the Greater Toronto Area (GTA), we sent a survey of 11 questions via email to genetic laboratory directors in Ontario in July 2019 and also September to October 2019 since there was a paucity of data for critical values in genetics.

Based on the data, the Council formulated proposed guidelines that were circulated to individuals from Ontariogenetic laboratory centres and respondents of the survey in November 2021, who supplied feedback.

We recommend all genetic laboratories consider implementing these guidelines into their critical value reporting.

Please supply any feedback on the guidelines or their implementation to Dr. Elaine Goh.

Critical patient type

  • Prenatal
  • Newborn
  • Oncology or
  • Expedited by the ordering physician

Critical results

  • Cytogenetics: Prenatal abnormal rapid aneuploidy testing or microarray findings
  • Molecular: Unexpected results, and pathogenic variants in prenatal setting (Indeterminate results taken off after feedback from Ontario genetic laboratory centres).

Reporting process

  • Insufficient or incorrectly labelled samples: Do not limit to reporting via mail
  • Critical results: Suggest in addition to routine process to either also call, email and/or fax the ordering provider.

Other resources on this topic

Authors / contact

Compiled by

Dr. Elaine Goh
Assistant Professor, Department of LaboratoryMedicine and Pathobiology, University of Toronto
Division Head of Clinical Genetics, Trillium Health Partners

elaine.goh@thp.ca

Contributor

Dr. James Stavropoulos
Assistant Professor, Department of Laboratory Medicine and Pathobiology, University of Toronto and Clinical Lab Director of Genetics at The Hospital for Sick Children

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Defining and Reporting on Critical Values in Genetics: A Laboratory Survey (Paper)

Harmonization of critical values
Jun 4, 2021

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As part of an initiative to harmonize critical value reporting across genetic laboratories in the Greater Toronto Area (GTA), we sent a survey of 11 questions via email to genetic laboratory directors in Ontario in 2019.

The report has been published in the Journal of Applied Laboratory Medicine: Goh ES, Stavropoulos DJ and Adeli K. 2021 

Defining and Reporting on Critical Values in Genetics: A Laboratory Survey

Authors / contact

Compiled by

Dr. Elaine Goh
Assistant Professor, Department of LaboratoryMedicine and Pathobiology, University of Toronto
Division Head of Clinical Genetics, Trillium Health Partners

elaine.goh@thp.ca

Contributor

Dr. James Stavropoulos
Assistant Professor, Department of Laboratory Medicine and Pathobiology, University of Toronto and Clinical Lab Director of Genetics at The Hospital for Sick Children

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View an update from the project team

We held a workshop on May 5, 2021, covering an update and discussion on the project, presented by Dr. Elaine Goh and Dr. Felix Leung.

Other available guidelines

GP47 Management of Critical- and Significant-Risk Results, 1st Edition

This guideline provides current best practice recommendations for developing and implementing a policy and procedures for the identification, reporting, and management of critical- and significant-risk laboratory results.

It emphasises management responsibilities such as development of the policy, the process, procedures, job descriptions, and monitoring systems that ensure effective reporting and compliance with regulatory requirements.

Relevant publications for further information

Establishing, harmonizing and analyzing critical values in a large academic health center. Hashim IA, et al. Clin Chem Lab Med 2014;52(8):1129-35. doi: 10.1515/cclm-2014-0029. PMID: 24622791.

Critical risk results – an update on international initiatives. Lam Q, et al. eJIFCC. 2016;27(1):66-76. PMID: 27683507.

Laboratory critical values policies and procedures: a College of American Pathologists Q-Probes Study in 623 institutions. Howanitz PJ, et al. Arch Pathol Lab Med. 2002;126(6):663-9. doi: 10.1043/0003-9985(2002)126<0663:LCVPAP>2.0.CO;2. PMID: 12033953.

Harmonization of critical result management in Laboratory Medicine. Campbell CA, et al. Clin Chim Acta. 2014;432:135-47. doi: 10.1016/j.cca.2013.11.004. PMID: 24246790.

Latest news

Sep 23, 2021
A team at the University of Toronto has just published the first study of Ontario genetics laboratories' practice of reporting critical values to help define standards for the industry.

No upcoming events were found.

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