Resources and recommendations from the LMP Quality Council

Originally published February 8, 2022. Updated and republished February 17, 2023.

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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 Ontario genetic 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.

Update to guidelines 2023

One year after this guideline was published, we emailed the participating laboratories to gather further feedback.

The Ontario laboratories indicated:

• they were following the guideline
• the guideline allows for standardization of practices across the Ontario genetics laboratories
• slight rewording of the critical results was needed which has been updated below and in the attached PDF download.

Critical patient type

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

Critical results

• Cytogenetics: Abnormal prenatal aneuploidy, microarray and susceptibility loci
• Molecular: Unexpected results, and pathogenic variants in prenatal setting 

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

• The report has also 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
• You can read about the project in a news story: Lab tests that impact lives: harmonizing critical values

Authors / contact

Compiled by

Dr. Elaine Goh
Assistant Professor, Department of Laboratory Medicine 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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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.

• Download the full Biochemistry and Haematology Critical Values document (PDF)
• Download the summary table (one page) only (PDF)

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

• pCO₂ 
• pO₂ 
• Glucose
• Magnesium
• Osmolality
• Sodium
• Fibrinogen
• Neutrophils

High Critical Value

• pCO₂ 
• 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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May 25, 2022

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Hosted by Dr. Paul Yip, the LMP Quality Council discuss putting quality indicators into action with the clinical core laboratory community. Speakers include Dr. Lusia Sepiashvili, Dr. Davor Brinc and Dr. Saranya Arnoldo.

Watch the recording on YouTube

Answer a survey about the project (5 mins)

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Survey of Current Practices for Quality Indicators in the Core Laboratory within the GTA

Quality indicators (QIs) are systematically measured data collected to monitor laboratory performance. They are an essential part of the quality management system that leads to process improvements and good decision-making. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has established the IFCC Model of Quality Indicators (MQI) framework to harmonize laboratory metrics, thereby informing better practices to improve patient safety. 

The LMP Quality Council sought to understand current practices within Greater Toronto Area (GTA) hospitals regarding QIs in the core laboratory environment (i.e. routine biochemistry and hematology testing). 

A preliminary consensus of 10 core laboratory QIs spanning the total examination process was the result of a survey in 2020. The data will allow the Council to make recommendations for laboratories to align their QIs and enable benchmarking among peers. 

Responses from 15 laboratories are summarized as follows:

• The monitoring of turnaround time (TAT) was employed by all (100%) of respondents that included testing for troponin (93%), INR (93%), WBC / CBC panel (86%), and potassium / electrolyte panel (86%). However, the individual definitions of TAT may be influenced by the timing interval within the examination process, the percentile threshold for test results, the locations monitored, and the target TAT itself. 
• The majority of laboratories reported the inclusion of QIs for: misidentification errors (93%), performance in EQAS-PT schemes (100%), hemolyzed samples (80%), incorrect fill levels (73%), notification of critical results (80%), and clotted samples (80%). However, the quantitative definition of individual QIs varied across users with few reflecting the IFCC recommended practice to express metrics as a percentage of a total number. Responses suggested that some of the above QIs were monitored informally or by an alternative means.
• The full adoption of all 10 QIs should be considered by GTA hospital laboratories, which are considered high priority by the IFCC for their impact on patient safety.  At the same time, metrics need to be standardized before meaningful assessment of quality can be made using quantitative QI data. Therefore, the LMP Quality Council recommends that laboratory stakeholders collaborate to achieve harmonization of these quality indicators.

Draft Recommendations for Key Core Laboratory Quality Indicators

This document summarizes the interim practice guidelines for clinical laboratory quality indicators as a result of surveys and engagement with laboratory professionals from the academic teaching hospitals affiliated with the University of Toronto. A standardized approach in this guideline will allow common benchmarks and identify priority areas for improvement efforts across hospitals in the GTA.

Key messages

Laboratories should include all of the following high-priority quality indicators for regular monitoring of critical processes that impact patient care.

Pre-Examination Phase:

• Misidentification errors
• Incorrect fill level
• Hemolysed samples
• Clotted samples

Intra-Examination Phase:

• Unacceptable performances in EQAS-PT schemes

Post-Examination Phase:

• Inappropriate turnaround time (TAT) for STAT potassium
• Inappropriate TAT for STAT INR
• Inappropriate TAT for STAT WBC
• Inappropriate TAT for STAT troponin
• Notification of critical results

Laboratories should report the quality indicators according to the IFCC harmonization model to enable comparability with performance benchmarks. 

Pre-Examination Phase:

• Percentage (number of events / total number of orders)

Intra-Examination Phase:

• Percentage (number of EQAS-PT flags / total number of survey challenges)

Post-Examination Phase:

• Percentage (number of released results outside the specified TAT / total number of released results)
• TAT: Time (minutes) at the 90th percentile (STAT)

Quality Indicator Performance Reports:

• Detailed reports should be prepared for laboratory monitoring on a monthly basis.
• Overall performance reports should be shared with stakeholders on a quarterly basis.

References

• Current Practices for Quality Indicators in the Core Laboratory within the GTA.
• IFCC model of quality indicators (MQI). Clin Chem Lab Med. 2017;55(10): 1478-1488. Defining a roadmap for harmonizing quality indicators in Laboratory Medicine: a consensus statement on behalf of the IFCC Working Group “Laboratory Error and Patient Safety” and EFLM Task and Finish Group “Performance specifications for the extra-analytical phases”

Authors / contact

Compiled by

Dr. Paul Yip

Associate Professor, Department of Laboratory Medicine and Pathobiology, Sunnybrook Health Science Centre and University of Toronto

paul.yip@utoronto.ca

Contributors

Paul Yip, Davor Brinc, Daniel Beriault, Felix Leung, Lusia Sepiashvili, Saranya Arnoldo, Cristiana Stefan, Nelson Cabral, Zeina Ghorab, Corwyn Rowsell, and Khosrow Adeli

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Disruptions in global supply chains due to COVID-19 have resulted in global supply constraints related to bloodcollection tubes. Supply constraints for blood collection tubes are expected to stabilize in the coming months. However, current shortages are impacting all healthcare organizations and there is a need for immediate action to conserve tubes.

Suggested conservation strategies are below.

Optimize

For Clinicians

• Do not order non-essential laboratory tests; critically assess the potential for a test result to impact immediate patient care before ordering.
• Avoid blood work in stable or asymptomatic outpatients.
• Avoid blood work in alternate level of care patients.
• Do not order routine standing orders and consider cancelling unnecessary standing orders.
• Do not perform annual screening blood tests unless directly indicated by the risk profile of the patient.
• Consider reviewing or pausing medical directives, order sets and order panels in clinical areas where blood work is drawn routinely (e.g. Emergency Department).
• Refer to Choosing Wisely Canada recommendations (below) for appropriate test utilization guidance for specific clinical situations.

For Laboratorians

• Laboratory medicine departments should consider validation of alternative blood collection tubes and supplies.
• Consider reviewing blood draw practices with local stakeholders to identify opportunities to reduce blood draws.
• Consider partnering with local laboratories to share supplies and off-set respective critical shortages.

Consolidate

For Clinicians

• Review previous laboratory test results including point-of-care test results that may have already included the test of interest, for e.g., glucose meter checks and electrolytes on blood gas analyzers.
• Whenever possible, add-on tests to existing blood draws.

For Phlebotomists and Laboratorians

• Follow laboratory guidelines on grouping tests on single tubes to make the most efficient use of tubes and collection.

Communicate

For all

• Engage with local laboratory medicine and procurement teams to gain awareness of the status of supplies, recommended usage, and validated alternatives.
• Ask your hospital or community laboratory for clarification on unnecessary tests and procedures.
• Connect with your local data analytics team to consider feasibility of development of a blood collection tube dashboard to best track supply and demand, send alerts, help inform the feasibility and safety of clinical care ramp up based on blood tube availability.

Other resources: Choosing Wisely Canada

• Conserving lab resources in primary care (PDF)
• Conserving lab resources in hospitals (PDF)

Contact

Dr. Michelle Sholzberg

References

• Ontario Association of Medical Laboratories
• Choosing Wisely Canada
• Ontario Association of Medical Laboratories
• Canadian Society of Clinical Chemists (CSCC)
• Canadian Association of Medical Biochemists (CAMB)

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Over the past several years, consensus has been built in Ontario regarding the essential quality indicators that should be monitored and reported by pathology laboratories. These indicators have been described in the Standards2Quality document co-authored by the OMA Lab Medicine Section and the OAP, and many indicators were subsequently mandated by the CCO/CPSO Quality Management Program (QMP). While the QMP has been discontinued, most labs have adopted routine monitoring of certain indicators as part of their standard practice.

Despite the general consensus around which indicators should be followed, there has been little effort to determine whether these indicators are defined, collected, and interpreted in a similar way between laboratories. The guidelines below focus on particular quality indicators based on findings from a survey that was circulated to laboratories in the greater Toronto area in April 2020.

Please supply any feedback on the guidelines or their implementation to the authors.

Intraoperative consultation (IOC) versus final diagnosis correlation

1. Assessment of IOC versus final diagnosis correlation should be recorded on all specimens that have had IOC performed.

The correlation should be between the IOC diagnosis and the final interpretation of the specific question being asked of the pathologist on the sample of organ or tissue given for frozen section.

Example

A sample of a liver lesion in a patient undergoing surgery for pancreatic carcinoma is sent for IOC. The pathologist performs a
frozen section and interprets the finding as “adenocarcinoma”. The pathologist who receives the final case agrees with the interpretation based on both the frozen section slide and the permanent section. 

This would be a concordant result.

Example

A lung wedge resection with a tumour is received for IOC, specifically assessment of the parenchymal margin. The pathologist renders their intraoperative assessment of “margin grossly negative” based on gross visual inspection; no frozen section was performed. On final pathology, the margin is histologically involved by tumour. 

This would be a discordant result.

Example

A minute sample of brain is sent for IOC to assess for lesional tissue, and a smear is performed. The pathologist's interpretation is “normal brain tissue”. Another specimen is sent by the surgeon for permanent section. The pathologist interpreting the final agrees with the interpretation of the smear, but the second specimen demonstrates a glioblastoma.

This would be a concordant result.

2. Assignment of final pathologistshould be based on IOC.

Different laboratories have developed their own approaches in terms of designating the final pathologist responsible for a case based on IOC. Some laboratories specifically assign cases to apathologist who did not perform the IOC to minimizebias in doing IOC vs final correlation.

Others routinely assign cases to the pathologist who performed the IOC. Either of these approaches may be pragmatically challenging for some departments; for example, departments where specimens are assigned by subspecialty for which there is a small subspecialty group or even a single pathologist responsible for a specimen type.

For cases that had an IOC, it is recommended that case assignment be performed as per routine case assignment protocols, without regard to who performed the IOC.

3. In addition to concordance, it is recommended that when discordances occur, the reason for discordance is documented.

Possible reasons may include interpretive, sampling, or technical errors, or the final diagnosis may have only been feasible using ancillary tests that could only be performed on permanent sections. This should be documented in the LIS, for the purposes of evaluating the IOC process and identifying areas for quality improvement.

4. When discrepancies occur, prompt assessment of the patient impact is important in order to mitigate harm to the patient involved, as well to consider possible measures to improve processes for the future.

Some discrepancies may not result in any impact or harm, while others may be categorized as minor or major impact.

Departments should develop and implement policies that provide guidance to pathologists regarding appropriate investigation and disclosure when an IOC discrepancy is deemed to have impacted patient care.

Turnaround time (TAT)

1. Overall TAT, incorporating all specimen types regardless of priority, is a commonly used quality indicator but is of limited utility as trends for specimen types that may have greater impact on patient care may be obscured.
2. Separation of specimens into a diagnostic biopsy category versus a resection category may be more helpful in determining meaningful TAT trends.
3. Specific exclusion of specimen types that tend to have longer TAT is not recommended. Some labs exclude “outlier” specimens, such as placentas or bone specimens requiring decal. These specimens may have impactful diagnoses, and thus TAT for them should be tracked as part of a quality assurance (QA) program.
4. Targeted TAT for particular specimen types may be of value to achieve specific institutional goals or to comply with regional targets.

Prospective reviews

1. Prospective reviews with another pathologist should be recorded for quality assurance purposes. This may also be of medicolegal value in challenging cases where a diagnosis is later disputed.
2. Various professional groups have developed different methods of recording prospective reviews. Most involve either recording directly in the pathology report or a QA module or retrieval flag in the lab information system. For optimal impact and transparency, recording the review in the pathology report, including the name(s) of the reviewer(s), is recommended.
3. The nature of the review should also be recorded; for example, if the review was based on assessment of all slides and ancillary studies or if it was a limited review based on selected slides.

Critical results

1. All pathology groups should have a list of critical results. These may be based on published lists (e.g. from ADASP) but maybe modified to reflect local practice. Such lists are not all-encompassing, and professional judgement still plays an important role in determining what constitutes a result that merits the immediate attention of the responsible physician.
2. Delivery of critical results must be prompt and to the physician responsible for management of the patient. While real-time discussion by telephone or in person is optimal, other electronic means of communication such as email may be acceptable provided that the message is promptly acknowledged by the recipient.
3. The fact that a critical result was delivered must be documented. Documentation should include what was communicated, when the message was delivered, and to whom the information was given. Ideally, this should be recorded in the pathology report. Other methods of recording in the lab information system may be useful for tracking purposes.

Authors / contact

Compiled by

Dr. Corwyn Rowsell
Associate Professor, Department of LaboratoryMedicine and Pathobiology, University of Toronto
Corwyn.Rowsell@unityhealth.to

Dr. Zeina Ghorab
Assistant Professor, Department of LaboratoryMedicine and Pathobiology, University of Toronto
zeina.ghorab@sunnybrook.ca

Contributors

Sakinah A Thiryayi, Paul Yip, Khosrow Adeli

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Cortisol assays are poorly standardized across different platforms and methods. A single cortisol cut-off for the ACTH Stimulation Test for adrenal deficiency often differs depending on the testing laboratory. Laboratories generally do not include thresholds for ACTH Stimulation Tests on their reports.

The list below provides the immunoassays used to assist Endocrinologists in the interpretation of cortisol levels where bias may exist between laboratories.

Please contact the laboratory’s biochemist for further information.

Key to Method Principle in table

• CMIA: Chemiluminescent Microparticle Immunoassay
• CLIA: Chemiluminescence Immunoassay
• ECLIA: Electrochemiluminescence Immunoassay

Manufacturer: Abbott

Manufacturer: Beckman

Manufacturer: Roche

Manufacturer: Siemens

References

Serum Cortisol: An Up-To-Date Assessment of Routine Assay Performance.

Screening for Nonclassic Congenital Adrenal Hyperplasia in the Era of Liquid Chromatography-Tandem
Mass Spectrometry.

Clinical implications for biochemical diagnostic thresholds of adrenal sufficiency using a highly specific
cortisol immunoassay. 

Authors / contact

Compiled by

Dr. Paul Yip

Associate Professor, Department of Laboratory Medicine and Pathobiology, Sunnybrook Health Science Centre and University of Toronto

paul.yip@utoronto.ca

Clinical lead

Dr. Julie Gilmour

Contributors

Khosrow Adeli, Saranya Arnoldo, Daniel Beriault, Lei Fu, Davor Brinc, Felix Leung, Hui Li, Zahraa Mohammed-Ali, Atoosa Rezvanpour, Lusia Sepiashvili, Kun-Young Sohn, Cristiana Stefan, Uvaraj Uddayasankar, Paul Yip

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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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We held a workshop on May 5, 2021, covering an update and discussion on the various projects of the LMP Quality Council.

Watch the recordings on Vimeo.

Video 1: Introduction and Quality Indicators

Clinical Laboratory Quality Indicators and harmonization across the GTA hospitals (part one of a Quality Council workshop)

Introduced by Dr. Khosrow Adeli and presented by Dr. Paul Yip and Dr. Corwyn Rowsell.

Video 2: Test Utilization

Appropriate laboratory test utilization to enhance patient safety and reduce waste (part two of a Quality Council workshop)

Presented by Dr. Michelle Sholzberg and Dr. Daniel Beriault.

Video 3: Harmonization of Critical Values

Harmonization of critical values across the GTA hospitals (part three of a Quality Council workshop)

Presented by Dr. Elaine Goh and Dr. Felix Leung.

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