UNDER THE MICRCOSCOPE
Dr. Raymund W. Lo
I’d like to share my observations on the clinical laboratory regulations in the Philippines with the reprinting of my article which was published in the Philippine Journal of Pathology (Vol.6 No.2 December 2021), as this gives a background on the challenges faced by Clinical Pathology practitioners:
(Part I)
I write this article from my perspective of 34 years of practice in the Philippines having arrived in 1987 from my training in the United States of America. In my six years of training first in Anatomic and Clinical Pathology then in Immunopathology fellowship, I have witnessed the workings of laboratory regulation and accreditation in that country and was in culture shock when I started my practice here.
Laboratory automation was well underway in the Western hemisphere during my training. Hematology and chemistry at the forefront of this technological revolution. But other disciplines were starting to catch up. Locally, few tertiary labs were starting to automate. I was, of course, excited to begin revolutionizing the practice of Clinical Pathology.
I had not counted on the backward state of laboratory regulation locally. Under the Department of Health regulatory office, Bureau of Research and Laboratories (BRL), inspection visits to the tertiary labs that I was connected with (one private and one government hospital lab), the inspectors were engineers who came with a list of requirements that included asking for Benedict’s reagent (for blood sugar manual testing) even though we were already using automated chemistry methods. This stopped only 10 years ago, thankfully when the BRL was renamed Bureau of Health Facilities Services (BHFS), now the Health Facilities Services Regulatory Bureau (HFSRB).
The other issue is that there tends to be over regulation. Elsewhere, the emphasis is on accurate laboratory test results which is achieved through good quality assurance programs and performing satisfactorily on semi-annual proficiency testing. On-site inspections are geared towards these goals as well as the right physical set-up necessary to achieve these results. Our local regulatory agency tends to aim at including training programs which normally are the province of professional societies.
An example is HIV testing. When it was first proposed, you have to apply for a separate HIV testing license apart from the license to operate a clinical laboratory. To get the license, a medical technologist must have to attend and pass an HIV Proficiency training course which includes counselling patients. The course was being given by Research Institute of Tropical Medicine (RITM) on a limited basis, thus, only few medical technologists were licensed, severely limiting the number of labs that can perform HIV testing.
I had argued against these regulations. The HIV antibody (and subsequently the HIV antigen test) test was a routine serologic procedure that can be done on a manual or automated method either by EIA or ECLIA. To run these tests, one needs only to be conversant with the requirements for running the samples like any other serologic examination.
Secondly, the ruling ignores the role of the pathologist who is responsible for the test result ultimately.
Third, the medical technologist is not the best person to be counselling patients. It is the attending physician who orders the test. Putting the burden of counselling on the med tech is a disservice to the patient and takes the med tech away from his/her main job, which is to run the tests.
We now have a situation where the regulatory agency prescribes training which is often unavailable but labs are expected to comply. The offshoot is that the few medical technologists who had the training became highly sought after to be able to put up HIV testing in clinical labs, leading to a black market where these techs offer their licenses for a fee. (Addendum: The HIV training requirement was recently removed.)
The requirement for pre- and post-test counselling actually deterred patients from testing since it attaches a stigma to the disease which was what the regulation was supposed to remove. In other countries, one can simply walk into a lab and ask for the HIV test without any additional requirements. Some even offer anonymous testing.
All these factors — limited testing, counselling requirements and the attendant stigma attached may have led to the explosive increase in HIV cases we are seeing now in the Philippines.
Fast forward to today and not much has changed. With the SARS-CoV-2 pandemic, molecular laboratories for RT-PCR testing of the virus had to be set up quickly to enable adequate testing. Regulations governing the physical set up described a sample laboratory design with instructions on one way flow. It was not meant to be the template but when we submitted our design following the instructions, it was not allowed. No matter how we modified it, it all boiled down to just follow the sample design, no matter if the space configuration did not allow for it. That to and fro took all of one month, precious time wasted at the height of the pandemic.
(To be continued)