Why must docs jump hurdles, through hoops to qualify for COVID-19 testing?Monday, January 25, 2021
There have been some unfortunate utterances about COVID-19 testing and laboratories over the past few weeks. I will confine my discussion to medical practitioners.
All practitioners who perform the following point-of-care (POC) tests are, in fact, operating a laboratory. These POC tests include urine, glucose, pregnancy, HIV, dengue, to name a few.
Until now, there has never been any discussion of, or a certification process for, performing any of these tests for practitioners. Indeed, the status of “laboratory” has never been applied to these settings.
Lo and behold, in the middle of a coronavirus pandemic, with people ill and dying, the introduction of a COVID-19 antigen test is creating a requirement of accreditation for practitioners to perform this POC test. This is the same test the US Centers for Disease Control and Prevention (CDC) says is suitable for settings such as physician offices, urgent care facilities, pharmacies, school health clinics, long-term care facilities and nursing homes, as well as temporary locations, such as drive-through sites managed by local organisations ( https://www.cdc.gov/coronavirus/2019-ncov/lab/point-of-care-testing.html).
The same test for which CDC says specimen collection should be performed in a normal examination room with the door closed, and health care workers in the room should wear an N95 or equivalent or higher-level respirator (or face mask if a respirator is not available), eye protection, gloves, and a gown (https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html).
The CDC further advises on the handling of waste generated during testing for COVID-19 patients in the same manner as all other biohazardous waste in the laboratory. Currently, there is no evidence to suggest that this laboratory waste needs any additional packaging or disinfection procedures ( https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html#lab-waste).
In essence, what we have is a simple test which practitioners are more than adequately equipped to perform.
Medical practitioners are having to jump hurdles and through hoops to qualify to do this test to manage patients seen on a daily basis. Meanwhile, our visitors are being guaranteed access to this testing on demand, ironically, to satisfy CDC requirements for entry to the US.
The public discourse continues to reference test kits and associated testing in the marketplace as being illegal. Where are the “legal” kits? When will practitioners be allowed access to them? The Ministry of Health and Wellness (MoHW) was set to launch its kits in Jamaica from August 2020. Should we not have resolved these issues by now?
All POC kits have a margin of error and require appropriate discussion in delivering the result. A negative HIV or pregnancy test does not mean you are not pregnant or don't have HIV, it simply means the test has not detected it, and there are many reasons, including timing of the test in relation to activity, which may produce this result. A similar analogy applies to the COVID-19 antigen testing. All told, there are many relevant discussions to be had about the accuracy of COVID-19 antigen tests.
The antigen test is designed to be most beneficial in symptomatic patients. In light of the pandemic and the potential value of early detection, that stipulation for use has been waived ( https://www.cdc.gov/coronavirus/2019-ncov/lab/point-of-care-testing.html).
In other words, asymptomatic patients are being included for testing, which potentially has the effect of skewing the perception of accuracy of this test.
Operating on the edge is not new to practitioners. At present there is no legislation in Jamaica governing digital medical records or telemedicine. Are practitioners who engage in these activities illegal operators? Should they wait for legislation to catch up before embarking on required, acceptable, and efficient practice methods?
I support the MoHW in its efforts against COVID-19. The obvious solution is to make approved kits available and hold recipients accountable for appropriate reporting. We need urgent solutions to what is a divisive issue, and one which is taking far too long to resolve.
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