Introduction
The sudden onset of the COVID-19 pandemic caused countries in Africa to reflect on the state of their diagnostic healthcare systems and governance. In health science, these laboratory systems are characterised as ‘quality systems’, which are defined as the organisational structures, resources, processes and procedures needed to implement high-quality management. The term ‘quality management system’ refers to coordinated activities that direct and control an organisation in order to produce laboratory quality data. Acknowledging this about health systems has led me to discuss the ignored questions about the quality of COVID-19 data in private healthcare institutions, as opposed to government facilities, in Nigeria. Government facilities are structured and mostly have defined control processes, certainly when compared to the country’s private healthcare facilities. For this reason, government institutions, or ‘tertiary’ institutions, are considered the highest tier of Nigerian healthcare.
Therefore, the focus of this paper is to investigate the quality of data held by privately owned laboratories’ in Africa, in order to assess the accuracy of COVID-19 testing across the continent. This is fundamental, as misinterpreted test results can result in harm to patients due to misdiagnoses. Most governments found their facilities lacked the capacity for sufficient testing during the initial COVID-19 outbreak. This led to the instating of private facilities as polymerase chain reaction (PCR) test centres.
This article has been created through experiences and interviews with a number of people affected directly or indirectly by the virus and laboratory system. Both location and personal identity remain confidential for ethical reasons. Due to word limitations, only one case is discussed in detail.
A case study of laboratory X, Lagos.
Laboratory X is one of the leading private laboratories in Nigeria. Its official name has been concealed as it is found in almost all states in Nigeria, with a high number of referrals issued to patients by hospitals in Nigeria. It is one of the listed facilities for the recommended PCR COVID-19 testing carried out in Nigeria. A PCR test costs 51,400 naira, which is equivalent to 128 US dollars.
I had a discussion with a lady who told me of her recent experiences with this facility. Due to a family emergency, she was scheduled to travel to London and needed the PCR test before boarding. Airlines have made it a compulsory requirement that passengers have a negative COVID-19 PCR test before leaving and returning to Nigeria. She did a drive-through PCR test in Lekki, Lagos. The results were expected within 72 hours of having the test. However, there was a delay in the lady receiving her results, which resulted in her calling the laboratory to enquire. A few minutes later, a doctor called from the lab and reported that she had tested positive and that she should come back for a retest two weeks later.
The lady was devastated. She was also asymptomatic. She related to me her mixed feelings upon receiving the news, one of which was her fear that she had affected her whole family, whom she had visited one night before she was tested. Certain elderly members of her family have comorbidities (diabetes and hypertension).
A recent study presented at the annual meeting of the Radiological Society of North America reported that COVID-19 patients with hypertension and diabetes are at higher risk of neurological complications, such as bleeding on the brain and stroke. The reported mechanism of action indicates that COVID-19 first attacks the cells in the respiratory system, often leading to an inflammation of the lungs and a risk of contracting pneumonia. But the virus’s impact has also been felt in other bodily systems, such as the central nervous system. In the study, 81 patients underwent a brain scan, and the findings suggested that one in five were emergency or critical cases. These included strokes, brain bleeds and blocked blood vessels. Three patients died while admitted. At least half of the patients had pre-existing high blood pressure and/or type 2 diabetes. The study further showed that two-thirds of patients with critical results were of black origin. The aforementioned lady felt a wave of guilt at the possibility of having infected her elderly family, who were black and had comorbidities. This acknowledgement led to the patient having a sudden exacerbated peptic ulcer attack. She had a ten-year history of this. A peptic ulcer is defined as a sore in the lining of the stomach or first part of the small intestine (the duodenum).
When an individual suffers chronic peptic ulcers, it is known as peptic ulcer disease (PUD). Stress is a risk factor for aggravating symptoms of PUD. Along with her feelings of guilt, the patient’s recent diagnosis and the fact that that cancelling her flight would lead to unexpected expenses acted as stressors. She resorted to self-medication, as she realised she could not go to the hospital for care. She decided to do a telephone consultation with her doctor the next day, and it was recommended that she retake the test in another laboratory for confirmation. She reluctantly followed this advice at further expense. However, the next day her result was emailed to her as negative. This led the lady to email laboratory X and demand a copy of her result, which was originally reported to her over the phone. This is clearly a red flag. Ideally, patients should receive a copy of their test results irrespective of the status of the report, i.e., a laboratory result should be documented and sent by email, rather than only being delivered verbally to a patient. A few minutes later, she was called again by a laboratory X employee, who told her that there had been a mix-up and her result was negative. She further demanded a soft copy of her test result. However, it took two months for the test result to be emailed to her. During that time, she called a partner of the lab. Her money for the test was eventually reimbursed. However, irrespective of existing evidence of the expenses she incurred for flight cancellation, money spent on drugs to treat PUD, time wasted before receiving accurate PCR results and emotional strain due to the misdiagnosis, the lab refused further compensation.
What are the foreseen consequences of laboratory misdiagnosis?
The case study discussed above shows that there is a weakness in the testing capacity of some private laboratories in Nigeria. Similar stories were conveyed to me during my research. Families reported the following:
1. A lack of faith in some private laboratories in the Nigerian healthcare system due to:
a. unforeseen financial costs, as, in the first case, the lady paid 51,400 naira, and although that money was refunded after two months, she lost money on changed flights, doctor’s consultations and money spent on PUD treatment due to the misdiagnosis; and
b. indirect costs due to the emotional strain of a positive test, which triggered her peptic ulcer.
2. Time wasted in cancelling her flight and missing out on a scheduled, significant family event.
3. Presentation of forged COVID-19 test results. On further investigation, some Nigerians, who had similar first-hand experiences, recommended against a repeat COVID-19 test. This was due to a perceived exploitation of Nigerian citizens by private laboratories in relation to COVID19 testing. It was reported that laboratories appear to make money if patients repeat a false positive result or if they need a false negative result, after being declared positive by the lab. A few Nigerians said that they would rather pay a smaller sum to lab personnel in order to have a fake COVID-19 test result, rather than pay an initial 51,000 naira and be subjected to emotional trauma, additional financial cost and stigmatisation if given a false positive result.
This discovery is in line with a recent report from the Nigerian Presidential Taskforce that indicates that travellers are presenting fake COVID-19 test results.
Are there impunities for a failed healthcare system?
A variety of laboratory mistakes can occur while administering tests, handling specimens or interpreting and reporting test results. Therefore, misdiagnoses made by laboratories most commonly qualify as negligence, as opposed to medical malpractice, given the laboratorians’ relative distance from the patient. Such instances include:
• unreasonable delays in testing,
• contamination of lab samples,
• lack of sufficient follow-up testing,
• failure to act in light of lab results,
• further errors in the laboratory testing process,
• contaminated specimens,
• recording inaccurate information,
• conducting the wrong test,
• misinterpreting results,
• mislabelling test samples, and
• mixing up samples and labels.
A clearer definition of medical negligence was established by the State of New York’s Court of Appeals, in the case of Bleiler v. Bodnar, 65 NY2d 65, 72, 479 N.E.2d 230, 489 N.Y.S.2d 885 [1985]. In this case, the court defined medical malpractice as ‘negligent acts or omission . . . that constitutes medical treatment or bears a substantial relationship to the rendition of medical treatment by a licensed physician’. The initial part of the definition (‘acts or omission that constitutes medical treatment’) refers to the acts of a licensed physician. The second part of the definition (an act or omission that ‘bears a substantial relationship to the rendition of medical treatment’) relates to the degree of the acts and the omissions of other healthcare practitioners, such as laboratory personnel, but only if these acts and omissions bear a substantial relationship with the diagnosis or treatment of a particular patient.
However, the reported case in this article appears to show that some private laboratories believe they have the autonomy to act or omit laboratory diagnoses, as it is presumed that there are no impunities or sufficient checks and balances for negligence in the private laboratory system. For example, in the case of laboratory X, there was a misinterpretation of results and a poor turnaround time. There was a failure on the laboratory’s part to release the result. This took over a month, even after a reconfirmed misdiagnosis was made by the lab. In spite of this, the laboratory denied a complete refund to the patient. This act can be qualified as medical negligence, and in an ideal world, victims of medical laboratory errors would be eligible for compensation for:
• hospital bills, such as consultations with doctors;
• other expenses, such as money lost on flights;
• pain and suffering;
• disfigurement or disability, such as exacerbated PUD, due to wrong diagnoses; and
• wrongful death of a family member (not applicable in this case).
Conclusion
There should be properly executed health policies on turnaround time, accuracy and reliability for COVID -19 testing and also penalties for medical negligence (as perceived in similar laboratories).
Penalties for medical negligence would prevent increased infection rates caused by testing inaccuracies and strengthen the healthcare system. For instance, laboratory X only issued a refund to the patient after she threatened legal action. But the laboratory refused to pay the aforementioned additional costs, insisting that it is not their policy to compensate patients due to misdiagnosis.
These experiences have led me to question whether or not patients are aware of their human rights in relation to medical negligence in healthcare? The quality of healthcare data should be seen as a priority, as it is the route to treatment, recovery and the general wellbeing of every patient that walks into a healthcare facility in Nigeria.
The cost of private COVID-19 testing could be reduced in an effort to diminish the temptation for technicians to make deliberate misdiagnoses and to encourage citizens to actually do the test. Reports indicate that travellers avoid doing pre- and post-travelling COVID-19 tests in private labs in Nigeria.
In summary, misdiagnosis not only affects a patient psychologically and financially but may also have a detrimental impact on a patient’s physical health, as illustrated by the above case study. The quality systems discussed in this paper indicate that data on COVID-19 testing in private healthcare may need to be regulated by the Africa Centres for Disease Control and Prevention, as there are profound weaknesses in the organisational structure, resources, processes and procedures of some private laboratories. This is, of course, a case study, so it may be argued that, scientifically, its findings might not be generalised to all private laboratories in Nigeria or Africa. Therefore, more detailed investigation is required in this area.
