UNDER THE MICROSCOPE
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 II)
Training of pathologists was fortunately delegated to the Philippine Society of Pathologists Inc. (PSPI), rightly so since professional organizations should be conducting training and proficiency testing, as is being done in most countries.
Training of medical technologists was given to the Research Institute of Tropical Medicine (RITM) and the Philippine Genome Center (PGC), both government institutions engaged in SARS-CoV-2 testing exclusively in the early part of 2020. Unfortunately, both were much too busy with the routine testing, and in fact were overwhelmed by the volume of tests requested that medical technologist training was done on a limited basis, further exacerbating the shortage of available testing facilities. There are a number of private institutions already doing molecular testing that could have been requested to take part in medical technologist training but were largely ignored. Even today, formal training by these two institutions is required of analysts though training courses are still very limited. Yet, it is a mandatory requirement for renewal of licenses to operate. This puts the laboratories in a bind. They can’t get their staff trained due to the mandated institutions not offering the courses yet the regulatory agency rigidly requires it. Recently, the RITM has updated their training calendar to catch up with the backlog of required trainings.
The result is that no additional shifts to accommodate more testing can be opened by the laboratories. They are limited to the staff that have been previously trained. In the early days of the pandemic, the HFSRB allowed labs with previously trained staff to train their new recruits. That is no longer allowed. It speaks of yet again an inability to trust the pathologist and med tech staff to competently train their own new techs, something that is being done in all sections of the clinical laboratory. The RT-PCR technique has been elevated to an esoteric technique that requires formal training, like what was done with HIV testing earlier.
Now we are witnessing an effort by DOH to formulate new regulations for other molecular testing in all its forms: Infectious disease, cancer and genetic. Yet we have been practicing molecular pathology since the early 1990s. It is no longer exotic and is actually becoming part and parcel of clinical laboratory testing, much like ELISA and ECLIA were once deemed so advanced as to merit special training for HIV.
Many molecular tests are now very easy to perform. Cartridge-based molecular testing can even be done at point of care. Even Anatomic pathology practitioners do in-situ hybridization routinely for breast and other cancers. An offshoot of cancer molecular testing is that once identified, the protein that the gene codes for can also be targeted with immunohistochemistry.
Molecular testing is the future of clinical laboratory testing. If misguided regulations are put in effect, that may adversely affect progress of laboratory testing in the Philippines. We hope the DOH learns the lessons of the past so as not to repeat it in the future.
The regulatory agencies being burdened with many tasks and being short of technical staff should delegate tasks that can be done by others. It should coordinate with RITM and PGC to see if the assigned training tasks can be done properly and in due time. It should also tap private entities that are as capable as these agencies in trainings
There is hope in the establishment of the Office for Health Laboratories (OHL) which is headed by a pathologist. Since regulation will still be with the HFSRB, there should be regular meetings with the OHL, the PSPI and Philippine Association of Medical Technologists (PAMET) for updated implementation of regulatory policies based on current clinical laboratory progress in technology and knowledge.
In addition, the DOH should further strengthen its collaborative work with the Philippine Society of Pathologists Inc., and the Philippine Association of Medical Technologists in ensuring a smooth flow of licensing and compliance. The PSP and PAMET should be tapped for its members to assist the DOH inspection teams which will improve the process by better communication with the laboratory staff during inspection.
Currently, a Technical Working Group on Molecular Laboratory testing is working on the future provisions of future regulations. We wish it success for the seamless adaptation of molecular testing by local laboratories.