Clinical Laboratory Quality Indicators and harmonization across the GTA hospitals

Quality indicators allow laboratories to quantify the quality of laboratory processes, which is fundamental to patient safety. Harmonization of quality indicators is necessary to ensure that all clinical laboratories define, report and benchmark according to defined quality standards.

We aim to harmonize quality indicators across hospital-based clinical laboratories in the GTA that identify areas for quality improvement and enable sharing of best practices.

We have:

  • Surveyed hospital-based clinical laboratories across the GTA (Core Lab Quality Indicators survey and Anatomic Pathology Indicators survey)
  • Promoted the IFCC Model of Quality Indicators as a framework
  • Developed a list of proposed harmonized indicators

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Latest guidelines from the quality indicators working group

Key Core Laboratory Quality Indicators

Clinical Laboratory Quality Indicators and harmonization
Apr 22, 2022

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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

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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Pathology Quality Indicator Guidelines

Clinical Laboratory Quality Indicators and harmonization
Feb 2, 2022

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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 list

Clinical Laboratory Quality Indicators and harmonization
Jan 18, 2022

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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

Laboratory Platform Method Biochemist contact
LifeLabs Architect CMIA Dr. Uvaraj Uddayasankar
Sickkids Architect CMIA Dr. Lusia Sepiashvili
CAMH Alinity CMIA Dr. Cristiana Stefan
UHN Alinity CMIA Dr. Vathany Kulasingam

Manufacturer: Beckman

Laboratory Platform Method Biochemist contact
Scarborough UniCel DxI CLIA Dr. Zahraa Mohammed-Ali
Mackenzie UniCel DxI CLIA Maria De Oliveira

Manufacturer: Roche

Laboratory Platform Method Biochemist contact
Dynacare Elecsys ECLIA Dr. Hui Li
Humber River Elecsys ECLIA Dr. Atoosa Rezvanpour
Markham Stouffville Elecsys ECLIA Dr. Daniel Beriault
Michael Garron Elecsys ECLIA Dr. Paul Yip
Mount Sinai Elecsys ECLIA Dr. Felix Leung
North York Elecsys ECLIA Dr. Paul Yip
Sunnybrook Elecsys ECLIA Dr. Lei Fu
Women’s College Elecsys ECLIA Dr. Felix Leung

Manufacturer: Siemens

Laboratory Platform Method Biochemist contact
Lakeridge Centaur XPT CLIA Dr. Rajeevan Selvaratnam
St. Michael’s Centaur XP CLIA Dr. Daniel Beriault
St. Joseph’s Centaur XP CLIA Dr. Daniel Beriault
Trillium Centaur XP CLIA Dr. Kun-Young Sohn
William Osler Atellica CLIA Dr. Saranya Arnoldo

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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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. Paul Yip and Dr. Corwyn Rowsell.

The Core Lab Quality Indicator survey

Fifteen hospitals responded to our Core Lab Quality Indicator survey. The data has been published and used to prepare an evidence-based guideline for GTA-wide implementation which is now open to consultation.

A similar survey was developed for Anatomic Pathology and circulated to hospitals which has now been published.

The team helping implement the recommendations includes

Other working groups of interest

The Canadian Society of Clinical Chemists (CSCC) Special Interest Group on Quality Improvement through Quality Indicators Monitoring aims to improve our laboratory processes producing national benchmarks, sharing our experiences and promoting standardization efforts.

This initiative is based on the collaboration of the CSCC and the Program of Quality Indicators Comparison of the Quebec Society of Clinical Biology (SQBC). With the Working Group on Laboratory Errors and Patient Safety of the IFCC as a collaborator, activities will be aligned with the international standardization effort in the QI field. 

The Education and Management Division (EMD) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has established a Working Group on “Laboratory errors and patient safety”.

Other available guidelines

QMS12 Developing and Using Quality Indicators for Laboratory Improvement, 2nd Edition

  • QMS12 shows you a step-by-step way to develop quality indicators to measure processes, so your lab can provide quality testing.

Relevant publications for further information

Harmonization of quality indicators in Laboratory Medicine. A preliminary consensus. Plebani M, et al. Clin Chem Lab Med 2014;52(7)951-8. doi: 10.1515/cclm-2014-0142. PMID: 24622792.

Harmonization of pre-analytical quality indicators. Plebani M, et al. Biochem Med. 2014;24(1):105-13. doi: 10.11613/BM.2014.012. PMID: 24627719.

Towards harmonization of quality indicators in Laboratory Medicine. Plebani M, et al. Clin Chem Lab Med 2013;51(1):187-95. doi: 10.1515/cclm-2012-0582. PMID: 23023884.

Quality indicators for the total testing process. Plebani, et al. Clin Chem Lab Med 2017;37(1):187-205. doi: 10.1016/j.cll.2016.09.015. PMID: 28153366.

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". Sciacovelli L, et al. Clin Chem Lab Med. 2017;55(10):1478-1488. doi: 10.1515/cclm-2017-0412. PMID: 28688224.

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.

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