About the Author(s)


Lamla L.-R. Siganagana Email symbol
Department of Health Science, Faculty of Chemical Pathology, University of KwaZulu-Natal, Durban, South Africa

Department of Health Science, Faculty of Chemical Pathology, Stellenbosch University, Cape Town, South Africa

Verena Gounden symbol
Department of Health Science, Faculty of Chemical Pathology, University of KwaZulu-Natal, Durban, South Africa

Department of Clinical Biochemistry, Hospital Galway, Galway, Ireland

Unathi Ngxamngxa symbol
Department of Health Science, Faculty of Chemical Pathology, University of KwaZulu-Natal, Durban, South Africa

Citation


Siganagana LL-R, Gounden V, Ngxamngxa U. Audit of handling haemolysed, lipaemic and icteric samples in KwaZulu-Natal chemical pathology laboratories. J Med Lab Sci Technol S Afr. 2026;8(1), a129. https://doi.org/10.4102/jmlstsa.v8i1.129

Original Research

Audit of handling haemolysed, lipaemic and icteric samples in KwaZulu-Natal chemical pathology laboratories

Lamla L.-R. Siganagana, Verena Gounden, Unathi Ngxamngxa

Received: 23 June 2025; Accepted: 19 Mar. 2026; Published: 25 June 2026

Copyright: © 2026. The Authors. Licensee: AOSIS.
This work is licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) license (https://creativecommons.org/licenses/by/4.0/).

Abstract

Background: Pre-analytical errors in laboratory testing, such as haemolysis (release of haemoglobin and intracellular components), icterus (elevated bilirubin), and lipaemia (high lipid levels) collectively known as high concentrations of lipids (HIL) are common. Their detection, reporting, and mitigation require proper protocols.

Aim: This study assessed practices in handling chemistry samples affected by HIL within public laboratories in KwaZulu-Natal (KZN), focusing on detection methods and rejection monitoring.

Setting: This study was conducted at the National Health Laboratory Service (NHLS) chemistry laboratory at Inkosi Albert Luthuli Central Hospital, Durban, South Africa, between 01 August 2021 and 31 October 2021.

Methods: Standardised questionnaires were distributed to NHLS laboratories in KZN. Data from the NHLS Central Data Warehouse (August 2021 – October 2021) were extracted for commonly ordered chemistry panels (urea, electrolytes, liver function tests) to review HIL reporting. Analysis was performed using Microsoft Excel.

Results: Detection and management of HIL samples varied. Most laboratories did not report HIL interference, even with abnormal results, potentially compromising patient care. Failure to disclose interference reduces accuracy and reliability, affecting diagnosis and treatment. Some laboratories rejected haemolysed samples regardless of severity. For icterus and lipaemia, many laboratories did not specify corrective measures such as ultracentrifugation, microcentrifugation, or dilution.

Conclusion: Practices for detecting and managing HIL interference are inconsistent across KZN laboratories. A lack of standardised reporting and unclear handling protocols for icterus and lipaemia highlight the need for improved guidelines to ensure reliable patient results.

Contribution: This study provides insight into how NHLS laboratories in KZN were handling specimens affected by HIL.

Keywords: pre-analytical errors; HIL; laboratory protocols; standardisation; interferences.

Introduction

Patient safety, as well as the correct diagnosis and management of medical conditions, rely on accurate and reliable laboratory results.1,2,3 Errors in patient results can occur in the pre-analytical, analytical and post-analytical phases of sample analysis.1,3 Medical laboratory standards, such as International Organisation for Standardisation (ISO) 15189:2022, require medical laboratories to consider and monitor pre-analytical sources of error to ensure accurate and high-quality results.3,4,5

About 46% – 68% of these errors occur in the pre-analytical phase.1,3 The most common pre-analytical errors are haemolysis, icterus and lipaemia (HIL).6,7,8 The presence of HIL interferes with the measurement of assays, leading to affected results and incorrect interpretation.9,10,11,12 The occurrence of interference depends on the analyte and assay used.10,13,14 It is important that laboratory staff handle interferences correctly, as HIL may either increase or decrease the concentration of various analytes.9 Pre-analytical errors can be avoided by educating and training clinicians on the appropriate methods of blood sample collection and using the correct needle size. Education and training of laboratory staff on how to detect and manage these errors will prevent adverse effects of these interferents on patients.15,16 Laboratories should have protocols for identifying and handling HIL interference on analytes that may be affected. This can be achieved by visual inspection or by employing automated measurement of HIL interference. Automated measurement is preferred because it is reproducible and objective.17,18,19 Proper management of pre-analytical errors requires monitoring through audit and incidence reporting. Laboratory information systems (LISs) provide an effective way to monitor and record pre-analytical errors.5,20

In most countries around the world and in South Africa, there is no standardisation of laboratory practices for measuring and handling HIL interferences.20,21 National Health Laboratory Service (NHLS) networks of 250 laboratories in South Africa offer pathology services to most of the population. The KwaZulu-Natal (KZN) region is the second largest in population, covering great distances after Gauteng province. It is vital that the handling of HIL be standardised across the region to ensure patient safety. This study aimed to describe practices in the KZN NHLS laboratories handling specimens affected by HIL, allowing for the development and implementation of standard protocols within the region.

Research methods and design

The study was conducted during the period from 01 August 2021 to 31 October 2021. Information regarding practices of identifying and handling samples affected by HIL was collected via a survey. Survey questionnaires were sent electronically and via mail to laboratory managers, supervisors and quality assurance supervisors at the 55 KZN NHLS laboratories that process chemistry samples. Questionnaires sent electronically via email included a link to an online questionnaire. The surveys were anonymised. The questionnaire utilised was adapted from the one used in a study by Najat et al.3 The purpose of their study was to evaluate the management of pre-analytical errors, including HIL. Laboratory personnel voluntarily took a survey that assessed if they were monitoring and recording pre-analytical errors and, if so, what were the means of detecting, management methods, and recording of these errors. For the purpose of continuing quality, laboratories were asked if they were interested in being trained on best practices for HIL management and participating in the internal quality control (IQC) programme.3

An estimate of the frequency of reporting on the presence of HIL for routine chemistry results was determined by extracting data for the two most requested chemistry test profiles: serum urea and electrolytes (U&E) and liver function tests (LFTs). Table 1 lists the tests contained in each panel, and Table 2 lists the reporting of HIL grading as used by the NHLS LIS Trakcare (Intersystems, Australia).

TABLE 1: Tests included in the urea and electrolytes and liver function test profiles.
TABLE 2: Haemolysis, icterus and lipaemia grading as reported on the National Health Laboratory Service Trakcare laboratory information system.

Anonymised test result data from the NHLS Central Data Warehouse (CDW) were extracted for the 3 months for the KZN region’s NHLS laboratories, covering all U&E and LFT profiles performed. This data included the patient’s date of birth, hospital number and medical record number, laboratory sample number, results for each test, date of sample collection, sample type, HIL results, rejection status and any other comments included by staff. Data integrity was assessed by checking a subset of results from the CDW extract against the results available on the NHLS LIS. Furthermore, the number of samples for each profile, as provided by CDW, was compared to the NHLS management reports to ensure that no significant quantities of data were missing and that there were no duplicates. The analysers used for the generation of U&E and LFT profiles within the province included the following analysers: Siemens Dimension and Atellica, Roche Cobas 501, Roche c311 and Beckman Coulter DXC series, with the latter two not having automated HIL indices.

Data on returned questionnaires were captured on a Microsoft Excel (Microsoft, United States [US]) spreadsheet (password-protected), and further descriptive statistical analysis was performed using Microsoft Excel (Microsoft, US).

Ethical considerations

Ethical clearance for this study was obtained from the University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) (Ethical clearance certificate number BREC/00002198/2020).

Results

Survey results
Respondent characteristics

A total of 70 questionnaires were distributed, and a total of 50 responses were received (response rate of 71%). The characteristics of responding laboratories are as follows: the majority of responses (n = 26; 52%) were received from laboratories based at district hospitals, followed by laboratories at regional hospitals (n = 15; 30%), with 12% (n = 6) from academic hospitals. Laboratory technologists constituted the majority of respondents (n = 34; 68%), followed by laboratory managers and then quality assurance supervisors or designates as illustrated in Figure 1.

FIGURE 1: Percentage distribution of job titles of respondents.

Most respondents indicated that their laboratories analysed 1000–3000 samples per day, with 500–1000 chemistry samples (see Figure 3). Fifty per cent of respondents were from ISO 15189 standard-accredited laboratories, and 98% (n = 48) of respondents indicated that their laboratories provided both inpatient and outpatient services. Sixty-six per cent of respondents (n = 33) utilised a Siemens chemistry platform, while 14% had Roche analysers, and a further 20% used Beckman chemistry instruments. All the respondents monitored and reported HIL for routine biochemistry tests, while 16% of respondents also reported these for toxicology and therapeutic drug monitoring tests as illustrated in Figure 2.

FIGURE 2: (a, b) The total number of samples received and analysed per day and the number of chemistry samples tested per day.

Handling of haemolysis, icterus and lipaemia samples

Thirty-two (64%) respondents indicated that their laboratories assessed HIL indices using visual inspection alone, 5 (10%) respondents indicated that this was performed by only analyser detection, and 13 (26%) respondents indicated their laboratories used both methods to determine the presence of HIL. Eighty per cent of respondents (n = 40) indicated that their laboratory employed colour charts to assist with the visual assessment of haemolysis. With regards to the description of how the laboratories handle haemolysed specimens: 78% (n = 39) of respondents indicated that only tests affected by haemolysis would be rejected, while only one respondent (2%) indicated that all the tests for the sample would be rejected.

Thirty-eight respondents provided feedback that their laboratories used specific cut-offs for different assays in their laboratory for HIL indices. The majority of respondents (60%) indicated their laboratories utilised HIL cut-offs as supplied by the manufacturer.

Interventions for the handling of lipaemic samples

The distribution of answers about procedures in the respondents’ laboratories for handling lipaemic samples is illustrated in Figure 3. Unfortunately, the respondents who indicated ‘other’ did not provide further details of what procedures were being used for lipaemic sample handling.

FIGURE 3: Handling of lipaemic samples as per responses on the questionnaire (Online Appendix 1).

Reporting of samples affected by haemolysis, icterus and lipaemia

Sixty-seven per cent of respondents (n = 47) indicated that pre-analytical errors, including the presence of HIL, were reviewed routinely. Less than half of these (n = 22 of 47) employed LIS reports (46%) to monitor. Seventeen respondents indicated that this was manually documented, and four respondents indicated that both the LIS and manual methods were used. The rest (n = 3) did not provide further details regarding monitoring. Respondents indicated the samples affected or rejected because of HIL were monitored by the following statistical measures, as illustrated in Figure 4.

FIGURE 4: Percentage distribution of different metrics used to monitor samples affected by haemolysis, icterus and lipaemia.

Interventions

The questionnaire also attempted to elicit which interventions laboratory staff would be interested in implementing in their laboratories. Sixty-eight per cent (n = 34) of respondents indicated that they would be interested in their laboratories enrolling in an external quality assurance scheme for pre-analytical errors, including HIL. Ninety-eight per cent of respondents indicated that they would be interested in receiving training on best practice guidelines regarding pre-analytical errors, via e-learning programmes on pre-analytical error monitoring and best practices.

Review of laboratory data

A total of 994 447 results for U&E and LFT were collectively extracted for the period of 01 August 2021 – 31 October 2021.

Haemolysis review

A total of 397 481 potassium results were reviewed from August 2021 to October 2021 to determine (1) the number of elevated potassium results and (2) the number of these that had haemolysis indices performed or commented on. A total of 79 266 elevated potassium results were noted for the period of review.

Results (n = 14 413) with elevated urea and/or creatinine levels along with hyperkalaemia were excluded from further analysis in order to eliminate patients with true hyperkalaemia of renal dysfunction from those with pseudo-hyperkalaemia.

It was noted that 64 853 (81.8%) results with hyperkalaemia had no comment regarding haemolysis or no H index reported on the LIS. Table 3 shows the distribution of potassium results and the number of results with haemolysis reporting.

TABLE 3: Summary of potassium results and presence of haemolysis reported.

From the 18% of results that had haemolysis reported on, comments were inserted by laboratories from one academic hospital, four regional hospitals and 26 district laboratories.

Table 4 demonstrates reporting patterns of laboratories in different levels of care. The results revealed that there was not much difference in the reporting of haemolysis in potassium results between laboratories in tertiary, regional and district hospitals in KZN. However, upon observation of laboratory data, the majority of haemolysis reports came from one laboratory in an academic hospital. Review of the laboratory also demonstrated that laboratories in community health clinics do not report haemolysis.

TABLE 4: Haemolysis reporting patterns on potassium results according to hospital level of care.
Lipaemia review

The Lipaemia index was assessed for a total of 818 701 sodium samples for the 3 months of the study. Sodium was chosen because it is a commonly measured analyte, and lipaemia is a negative interferent. A total of 114 791 (14%) hyponatraemia results were reviewed for reports of the presence or absence of lipaemia index reporting. Only 7.8% (n = 9051) of the hyponatraemia samples had a lipaemic index reported, as noted in Table 5. The presence of lipaemia was confirmed in 802 (8.8%) of the hyponatraemia results, and 8249 (91.1%) had no lipaemia present.

TABLE 5: Summary of hyponatraemia results and presence of lipaemia reported.
Icterus review

A total of 994 234 (LFT and LFT with U&E) samples were analysed for 3 months from NHLS laboratories in KZN province for possible icterus interference on the reported results (Table 6). The presence of icterus was assessed using elevated total bilirubin (≥ 34 umol/L) results as a marker of possible icterus interference, and out of 29 572 samples with total bilirubin ≥ 34 umol/L, 28 133 (95.1%) had no comment or index reported to indicate the presence or absence of icterus.

TABLE 6: Summary of icterus reported on total bilirubin results.

Discussion

This study audited the practices of handling HIL interferences in blood samples by chemical pathology laboratories within the NHLS in KZN province in South Africa. Our study revealed that different laboratories within the same region and organisation differ in their management of these common interferences. One of the findings was that the majority (64%) of respondent laboratories utilised visual inspection to determine HIL indices, even though they had automated analysers capable of measuring HIL indices. Factors contributing to the lack of automated HIL measurement could be attributed to some of the analysers being over 10 years old in the region, a lack of awareness or training regarding the utilisation of automated HIL indices, or a lack of standardised procedures within the organisation.

The assessment of the 3-month laboratory data revealed that the majority of the NHLS laboratories in KZN do not report HIL interference, even in the face of significantly abnormal results for an analyte that could potentially be affected by these interferences. Thirteen thousand five hundred and sixty potassium results out of 14 197 results in the range of 6 mmol/L – 7.9 mmol/L had no haemolysis reported, which is 90% of that range not necessarily all results.

Furthermore, reporting on interferences is not consistent within the laboratories that do report on HIL presence or absence. In addition, the survey results revealed that the detection and management of samples affected by HIL are not uniform or standardised across the region. This was also demonstrated in a study by Cadamuro et al. in laboratories across Europe, which revealed that about 14% of the laboratories were not reporting on HIL, and among those that reported the implementation thereof, differed. Their study also found that even though their laboratories have automated analysers that can detect HIL, 58% of laboratory respondents still used visual inspection, with some using both visual and automated detection.16 A study by Farrell et al. also noted that the laboratories were not taking full advantage of the automated analysers.22 This could be because of a lack of understanding of the effects of these interferences on patient results, as well as reliance on visual inspection, as the majority (64%) of the respondent laboratories utilise visual inspection to determine HIL indices. Additionally, a lack of standardised protocols has resulted in different practices for managing HIL interference among different laboratories in the region, as demonstrated by the survey results. Furthermore, although the survey was sent to laboratory managers, supervisors and quality assurance (QA) supervisors or designates, it was noted that the majority of respondents were not senior personnel in the laboratory and may not have been fully aware of the laboratory’s procedures.

Education and training are likely the first steps needed to improve these practices. The implementation of standardised protocols for the reporting and handling of specimens affected by HIL would assist in this regard.14,23,24 Challenges in grading HIL also need to be addressed. While the NHLS has standard reporting of HIL indices on laboratory reports, different suppliers grade these indices according to their own specifications. There is no standardisation of the quantitative concentrations of the index that are equivalent to the qualitative grading systems. These grading systems also differ for different instruments from the same manufacturer.15,17,25

The implementation of standardisation in detecting and reporting HIL indices would also allow for benchmarking against local and international laboratories. Thus, enabling laboratories performing below the benchmark to review and implement strategies to improve their performance.26 Along with standardisation in reporting HIL indices, ensuring adequate quality control for its performance is also important. Before the introduction of analyser reporting of HIL, verification of the method should be performed. Ongoing IQC analysis, as well as participation in proficiency testing for reporting of HIL, should be part of the requirements for reporting a HIL result. Unfortunately, utilisation of IQC was not assessed in the survey; however, anecdotal evidence from the region indicates that this is not common practice.

Recommendations following the study’s findings are to increase the utilisation of automated detection of HIL indices where available. In some instances, respondents were utilising analysers older than 10 years. This should be addressed by timely analyser replacement and planning thereof to ensure current technology benchmarks are being used. In addition, the inclusion of HIL indices as a mandatory field in the test set of the LIS for all chemistry test sets, or at least the most commonly requested tests, is recommended. This would require the reporting of the HIL index, as the result could not be verified without this field, and would also encourage a shift toward automated detection methods, which are less time-consuming. A standardised protocol for the region needs to be developed to include both the above-noted strategies and guidelines on handling the sample when the HIL flags are detected. Furthermore, on-site audits must be planned so that the training of laboratory staff and the identification of HIL challenges on analysers can be documented and addressed. To assist with remedial plans, laboratories in the region must be compared using statistical analysis to determine which laboratories have high incidences of not reporting HIL, and if the lack of reporting HIL is significant when compared to the benchmark.

The strength of this study lies in the practical evaluation of HIL handling using data from the NHLS CDW. Furthermore, laboratory staff’s knowledge of handling HIL was assessed using questionnaires. The limitation of this study was the non-return and incomplete questionnaires submitted. Additionally, the information gathered regarding processes in the laboratories was dependent on respondents’ answers, and no physical on-site audits were performed. Furthermore, where respondents indicated ‘other’ from the options provided, further details were not sufficiently prompted for further interrogation. Thus, the quality of answers received may be a further limitation. Additionally, data were extracted for only two chemistry testing panels (urea, electrolytes and LFTs) to determine practices of HIL reporting.

Conclusion

This study demonstrates the lack of standardisation in the region investigated regarding the detection and handling of HIL indices. It provides a relatively simple area for the laboratories to improve their provided services, and consequently, the overall quality management system.

Acknowledgements

This article is based on research originally conducted as part of Lamla L.-R. Siganagana’s master’s thesis titled ‘Audit of handling haemolysed, lipaemic and icteric samples in KwaZulu-Natal chemical pathology laboratories’, submitted to the University of KwaZulu-Natal in 2024. The thesis is currently unpublished and not publicly available. The thesis was supervised by Unathi Ngxamngxa and Verena Gounden. The thesis was reworked, revised and adapted into a journal article for publication. The author confirms that the content has not been previously published or disseminated and complies with ethical standards for original publication.

Competing interests

The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article.

CRediT authorship contribution

Lamla L.-R. Siganagana: Conceptualisation, Data curation, Formal analysis, Investigation, Methodology, Visualisation, Writing – original draft, Writing – review & editing. Verena Gounden: Methodology, Software, Supervision, Visualisation. Unathi Ngxamngxa: Supervision. All authors reviewed the article, contributed to the discussion of results, approved the final version for submission and publication, and take responsibility for the integrity of its findings.

Funding information

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Data availability

Data were extracted from NHLS Central Data Warehouse, for the KZN region, for commonly ordered chemistry panels (urea, electrolytes, and liver function tests) to review reporting of HIL indices. It contained patient names, results and institutions and cannot be made available for public viewing.

Disclaimer

The views and opinions expressed in this article are those of the authors and are the product of professional research. It does not necessarily reflect the official policy or position of any affiliated institution, funder, agency or that of the publisher. The authors are responsible for this article’s results, findings and content.

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