Quality control (QC) in hematology laboratories ensures accurate diagnoses and patient safety. This article covers internal and external QC best practices, common challenges like variability and subjectivity, and how digital morphology with AI-driven decision support is improving outcomes.

Key Takeaways

• Laboratory Quality Control Impact: With laboratory results influencing ~80% of clinical management decisions, robust quality control (QC) systems are essential for analytical accuracy, result precision, and clinician confidence.
• Digital Integration Benefit: An integrated digital morphology and AI decision support ecosystem strengthens QC by delivering consistent, standardized, and reproducible results across laboratories and networks.

• Internal Quality control Benefits: Internal Quality Control (IQC), enabled by AI-driven tools, supports day-to-day operational reliability through standardized workflows, system performance monitoring, and standardizing morphological classification via high quality digital blood smear image review.
• Performance benchmarking: External Quality Control (EQC) provides objective benchmarking, proficiency assessment, and continuous improvement through inter-laboratory and peer comparison. AI-driven decision support enhances these workflows by continuously monitoring performance, flagging atypical findings, and supporting objective, rule-based classification.
• Reduced variability: Persistent challenges -variable smear preparation, operator-dependent interpretation, uneven expertise, and non-uniform screening criteria – drive inconsistent results and misclassification.
• AI Mitigation: AI decision support addresses these risks by providing objective pre-classification, rule-based alerts, and explainable recommendations for review.
• High Volume, High Quality Output: Automation integrated with digital microscopy, laboratory information system (LIS) combined with scalable training programs, enables laboratories to meet the growing test volumes, workforce constraints and rising expectations for quality outcomes with rapid turnaround times.

Quality control (QC) is the cornerstone of accurate and reliable diagnostic testing in hematology laboratories. By implementing both Internal Quality Control (IQC) and External Quality Control (EQC) measures, laboratories can achieve consistent performance and enhance diagnostic precision. ensuring accurate and precise processes to deliver reliable, reproducible, and relevant results. However, maintaining high standards comes with its own set of challenges.

Why is Quality Control so important in Hematology Laboratories?

Since laboratory results influence approximately 80% of clinical management decisions, implementing stringent quality control (QC) practices in haematology are essential.¹ The primary objective is to minimize errors that could lead to incorrect diagnoses or delayed treatments.¹

In hematology, QC aims to detect and address errors before results are reported, ensure test accuracy and precision, and build trust and confidence in the results for clinicians and patients.^1,2

By integrating automation, digital systems, and standardized protocols, laboratories can reduce error rates, enhance workflow efficiency, and prioritize patient safety.³

Within hematology laboratories, the implementation of a robust quality management system delivers several key benefits:¹

• Improved efficiency through reduced analytical errors, minimizing the need for repeat testing and conserving time, costs, and laboratory resources.
• Ongoing comparison of laboratory performance with peer institutions through internal and external quality control processes, supporting continuous improvement.
• Enhanced confidence in test results among clinicians, patients, laboratory management, and accreditation bodies.

What are the Best Practices in Quality Control in Hematology Laboratories?

Hematology laboratories must implement both internal (IQC) and external quality control (EQC) processes to achieve high-quality results.

Internal Quality Control (IQC)- Monitoring Accuracy within the Laboratory

IQC focuses on systematic methods to ensure test accuracy and reliability. Key aspects include:

• Standardized protocols help to ensure consistency in staining, fixation, and other preanalytical and analytical steps.⁴
• Routine checks are done to regularly assess hematology analyzers to ensure they function correctly.⁵
• Manual or Digital Blood Smear Review (MBSR): with microscopic analysis of well-prepared blood smears is done to verify results from hematology analyzers.⁶

External Quality Control (EQC): Learning Through Peer Comparison

EQC involves participating in external quality assessment schemes (EQAS) to compare laboratory performance with peers, helping to identify knowledge gaps and improve diagnostic accuracy.⁷

External quality control allows for the following benefits:^1,7

• Benchmarking: Comparing performance with other laboratories.
• Skill development: Training laboratory personnel to improve their diagnostic competencies.
• Error identification: Highlighting discrepancies in results for corrective actions.

What are the Key Challenges in Hematology Laboratory Quality Control?

Despite progress, laboratories face several hurdles in maintaining QC standards.

• Variability in Blood Smear Preparation Preparing high-quality blood smears is complex, influenced by factors such as storage time of blood samples before fixation, consistency in morphology across smears and staining procedures and reagent quality.⁸
• Subjectivity in Morphological Analysis Inherently subjective manual reviews demand high level technical expertise.6 Variability in training and experience can impact consistent and efficient application of peripheral blood smear (PBS) review criteria.⁴ Misclassification, such as identifying reactive lymphocytes as neoplastic cells, occurs in 10-26% of cases, highlighting the need for standardized training protocols.⁷
• Lack of Uniform Screening Criteria Key factors influencing which blood smears are sent for manual morphological review include the types of hematology analyzers utilized by the laboratories, staff expertise, laboratory workload volume, complexity of the laboratory services and financial constraints.6 Thus, only a subset of smear reviews are flagged for pathologist evaluation.^4,6

What solutions are available for Effective Quality Control in Hematology Laboratories?

Addressing the challenges of effective quality control in the haematology laboratory involves leveraging technology, training, and robust management systems.

1.Automation and Technology Integration

Modern hematology programs offer advanced features, such as:

• Self-check mechanisms for internal QC.⁶
• Digital microscopy systems to standardize morphological analysis.⁴
• Laboratory Information Systems (LIS) for streamlined data management and reporting.²

Automation reduces human error, improves accuracy, and speeds workflows, allowing laboratory staff to focus on complex analyses.^2,3

2. Comprehensive Training Programs Laboratory staff must stay current with best practices.³ Training programs should cover topics such as blood smear preparation and analysis, the identification of abnormal cell morphology as well as adapting to new digital and AI-based technologies and guidelines.
3. Establishing Context-Specific Criteria Standardized protocols for all stages -preanalytical, analytical, and postanalytical -should be implemented, including staining procedures and quality indicators.

What is the Role of Hematology Automation in Quality Control?

Hematology automation has transformed laboratory workflows by being able to rapidly and efficiently handle large sample volumes, minimizing subjective errors by reducing manual intervention and the ability of enhanced features to do automated flagging of abnormal results for review.

Where does the Future of QC in Hematology Laboratories lie?

Advancements shaping the future of quality control include:

• Digital Transformation: Adoption of digital microscopy and automation improves efficiency and reduces subjectivity.
• AI Integration: Artificial intelligence aids in morphological analysis, enhancing accuracy and consistency.
• Global Standardization: Universally accepted QC guidelines are gaining traction, ensuring uniformity across laboratories worldwide

Embracing these advancements will enhance diagnostic accuracy and contribute to better patient outcomes.

How is Scopio Labs Revolutionizing Peripheral Blood Smear (PBS)* and Bone Marrow Aspirate (BMA)** Evaluation and Improving Quality Control?

Scopio Labs’ Full-Field Digital Cell Morphology platform, powered by 100X high-resolution imaging, is setting a new standard. This fully digital, remote-capable workflow:^9,10,11

• Full-Field Digital Imaging: Provides detailed views of clinically relevant peripheral blood smear (PBS) areas and bone marrow aspirate (BMA) areas.
• Workflow Standardization & Turnaround Time Optimization: Streamlines workflows, reduces turnaround times, and enhances standardization, contributing to increased quality control.
• Remote Expert Collaboration: Enables real-time collaboration among hematology teams and remote experts via secure networks.

With Scopio Labs, hematology laboratories can significantly elevate their quality control practices.

Quality control is fundamental to the success of hematology laboratories. Effective QC is critical for ensuring the accuracy, precision, and reliability of test results. Addressing challenges such as standardization, subjectivity, and training gaps are essential for maintaining diagnostic excellence. By adopting innovations like automation, leveraging cutting-edge technology, as well as implementing robust internal and external quality management systems, laboratories can meet the demands of modern healthcare. These efforts ultimately improve patient outcomes and reinforce trust in laboratory medicine.

Disclaimers

* Scopio Labs’ Full-Field Peripheral Blood Smear application is CE marked and FDA-cleared, and its commercially available across the U.S., UK and Europe and other territories.

**Scopio’s Full-Field Bone Marrow Aspirate Application is CE-marked and cleared for sale in CE countries as well as in additional regions. Not commercially available in the US for in vitro diagnostic procedures.

***Scopio’s Full-Field remote capabilities are available through the secure hospital network.

FAQ

What quality control methods are used in hematology laboratories?

Quality control (QC) in hematology laboratories includes Internal Quality Control (IQC) and External Quality Control (EQC). IQC involves standardized protocols, routine performance checks, and manual blood smear review to verify automated results or digital blood smear review to accept or change AI-based classification and identification of cells.^4,5,6 EQC enables benchmarking against peer laboratories to identify discrepancies and improve diagnostic accuracy.⁷

How does digital technology enhance quality control in hematology labs?

Digital technology improves quality control by reducing subjectivity, standardizing morphological analysis, and minimizing human error12. Automation, digital microscopy systems, and laboratory information systems (LIS) support accurate result verification, automated flagging of abnormalities, streamlined workflows, and consistent data management across hematology laboratories. In addition, digital technology allows expert review from any location, not confined to the laboratory, as well as rapid turnaround time (TAT) and expert collaboration for challenging cases.

What role does staff training play in quality control for hematology labs?

Staff training is essential for maintaining quality control in hematology laboratories.³ Comprehensive training ensures consistent blood smear preparation, accurate morphological interpretation, and effective use of automated and digital systems.⁴ Ongoing education increases the comfort level of staff adapting to more digital workflows and automated technologies, reduces variability due to differences in expertise and supports adherence to evolving best practices and guidelines, as well as providing a valuable training tool.

How often should quality control checks be performed in hematology laboratories?

Quality control checks should be conducted on an ongoing and routine basis. Internal quality control includes regular system checks and result verification including expert review, if necessary before reporting,⁵ while external quality control is performed periodically through participation in assessment schemes, ensuring sustained accuracy, early error detection, and measurement of efficiency such as volume of samples and turnaround times to ensure consistent and increasingly efficient laboratory performance.1,7

How does Scopio Labs’ Full-Field Digital Morphology improve quality control?

Scopio Labs’ Full-Field Digital Cell Morphology platform captures all clinically relevant areas – from monolayer to feathered edge for Peripheral Blood Smear (PBS) and whole-slide imaging for Bone Marrow Aspirate (BMA) – at 100x resolution. This enables standardized morphological analysis, remote expert collaboration through secure hospital networks, and AI-powered pre-classification that reduces variability and supports consistent results across laboratories.

References

1. Sudarshan K, Das S, Hemalatha A, Raju K. Quality audit of haematology laboratory: Challenges and opportunities. Adv Hum Biol 2023;13:S75-9. doi: 10.4103/aihb.aihb_197_22 https:// journals.lww.com/adhb/fulltext/2023/05001/quality_audit_of_haematology_laboratory_.13.aspx
2. AlTamim AIZ, Alqurashy AAM,Alotaibi EAB, Albahlal AAM, Alsubaie AMA, Almutairi ALN, et al. Quality Assurance in Clinical Laboratories: Best Practices and Continuous Improvement Strategies. J Popl Ther Clin Pharmacol [Internet]. 2022;29(04):1365-74. Available from: https://www.jptcp.com/index.php/jptcp/article/view/5831
3. Mankar PD, Hatgaonkar K, Kohale MG, Wankhade RS, Bandre GR. Enhancing quality in hematology laboratory testing: A comprehensive review of preanalytical phase errors and prevention strategies. J Appl Hematol 2024;15:95-101. Available from: https://doi.org/10.4103/joah.joah_3_24
4. Moore M, Chen X, Sadigh S, Seifert R, Mindiola Romero AE, Pozdnyakova O, Courville EL. Evaluating pathologist practices in peripheral blood smear review: A comprehensive practice survey. Am J Clin Pathol. 2024:aqae091. doi: 10.1093/ajcp/aqae091.https:// pubmed.ncbi.nlm.nih.gov/39037433/
5. Goel S, Nisal AR, Raj A, Nimbargi RC. Analysis of hematology quality control using six sigma metrics. Indian J Pathol Microbiol. 2024;67(2):332-335. doi: 10.4103/ijpm.ijpm_352_23. https://pubmed.ncbi.nlm.nih.gov/38394423/
6. Comar SR, Malvezzi M, Pasquini R. Evaluation of criteria of manual blood smear review following automated complete blood counts in a large university hospital. Rev Bras Hematol Hemoter. 2017;39(4):306-317. doi: 10.1016/j.bjhh.2017.06.007. https://pubmed.ncbi.nlm.nih.gov/29150102/
7. Alcaraz-Quiles J, Molina Á, Laguna J, Rodríguez-García M, Gutiérrez G, Luis Bedini J, Merino A. Peripheral blood morphology review and diagnostic proficiency evaluation by a new Spanish EQAS during the period 2011-2019. Int J Lab Hematol. 2021;43(1):44-51. doi: 10.1111/ijlh.13319. https://pubmed.ncbi.nlm.nih.gov/32870604/
8. Vu QH, Van HT, Tran VT, Huynh TDP, Nguyen VC, Le DT. Development of a robust blood smear preparation procedure for external quality assessment. Pract Lab Med. 2021;27:e00253. doi:10.1016/j.plabm.2021.e00253. https://pubmed.ncbi.nlm.nih.gov/34458537/
9. Katz B-Z, et al. Evaluation of Scopio Labs X100 Full Field PBS: The first high-resolution full field viewing of peripheral blood specimens combined with artificial intelligence-based morphological analysis. Int J Lab Hematol. 2021;00:19. https://doi.org/10.1111/ijlh.13681
10. Bagg A, Raess PW, Rund D, Bhattacharyya S, Wiszniewska J, Horowitz A, Jengehino D, Fan G, Huynh M, Sanogo A, Avivi I, Katz BZ. Performance Evaluation of a Novel Artificial Intelligence-Assisted Digital Microscopy System for the Routine Analysis of Bone Marrow Aspirates. Mod Pathol. 2024 Sep;37(9):100542. doi: 10.1016/j.modpat.2024.100542. https://pubmed.ncbi.nlm.nih.gov/38897451/
11. Katz BZ, Benisty D, Sayegh Y, Lamm I, Avivi I. Remote Digital Microscopy Improves Hematology Laboratory Workflow by Reducing Peripheral Blood Smear Analysis Turnaround Time. Appl Clin Inform. 2022 Oct;13(5):1108-1115. doi: 10.1055/a-1957-6219. https://pubmed.ncbi.nlm.nih.gov/36208622/
12. Kim, H.; Hur, M.; d’Onofrio, G.; Zini, G. Real-World Application of Digital Morphology Analyzers: Practical Issues and Challenges in Clinical Laboratories. Diagnostics 2025, 15, 677. https://doi.org/10.3390/diagnostics15060677