UNDER THE MICROSCOPE

Having practiced pathology for the past 35 years, I believe I have the perspective on how laboratory regulation is done in this country. I’ve witnessed many instances of dysregulation. 

A prime example is HIV testing, which was deemed to be so sophisticated it needed to be highly regulated, with a two-week training for medical technologists and a license separate  from the clinical laboratory. Since training slots were very limited, it prevented a lot of labs from performing HIV testing, which meant loss of access for many at risk for HIV. It also spawned a black market for HIV-licensed medtechs, whose licenses were lent to labs to perform HIV testing.

Recently, the DOH issued AO No. 2021-0037: New Rules and Regulations Governing the Regulation of Clinical Laboratories in the Philippines, which among others, mandates hospital-based tertiary laboratories to have anatomic pathology services, including histopathology.

Histopathology is the diagnosis of diseases by examining tissues taken from patients. The anatomic pathologist (trained for at least three years and board certified by the Philippine Society of Pathologists) takes slivers of tissues from, say, a tumor; each tissue is processed and cut in very thin sections, which are placed on a glass slide and stained so that these can be visualized under a microscope.

Tissue processing is done by a medical technologist called a histotechnologist/histotech, who is specifically trained for that purpose. Histopathology is taught in medtech schools, but students don’t get any practical experience during their internships, since very few labs have a histopathology section. Thus, to be proficient in slide preparation, one must undergo specialized training under an experienced histotechnologist.

The slide preparation must be very well done for the pathologist to read the sections. A poorly-prepared slide (too thick sections, poor processing, bad staining, folds, and holes) may result in a wrong diagnosis, which will affect the treatment of the patient. It will also result in malpractice cases against pathologists.

Setting up a histopathology section will require buying several million pesos worth of equipment, acquiring enough space, and hiring histotechnologists.

The rationale for the requirement, as gleaned from online discussions of pathologists, is to ensure fast turnaround times for histopathologic diagnoses. In many provinces, it takes two weeks to a month or more to get the histopath report. The intent is laudable, but is this the way to achieve the desired result?

Except for large hospitals with busy operating schedules, smaller hospitals have much fewer surgeries, thus, fewer surgical specimens to be processed into tissue sections. The financial return on processing few sections is low, so they must resort to batching, which means waiting for the appropriate number of specimens to be processed economically. That will cause delay in relaying the histopathologic diagnosis to the surgeon. Déjà vu?

It also means that the hospital will not be able to recoup its investment in histopath equipment within the ideal five-year return on investment. Retrofitting the lab to add space for the section will also be costly, and almost all labs, even the biggest, are hard-pressed for space.

Most problematic is the hiring of histotechnologists. At present, there is no existing training program for histotechnologists locally. Hence, hospitals have nowhere to send their techs for histopathology training.

If these untrained techs produce poor quality slides, it will lead to inaccurate diagnoses. Patients will not be treated properly, since wrong diagnoses lead to the wrong treatment. Surely, this is an outcome we don’t want.

I’ve seen my share of poor quality slides from cases referred for a second opinion. It’s easy to understand how the pathologist who reads these slides can be misled.  But I guess they have no choice, since these are the slides produced by their histotechs.

What we need at this point is to start an honest-to-goodness histopathology training program to start churning out well-trained histotechs to man our histopath labs currently in existence. After training the requisite number of histotechs, that will be the time to gradually require the larger hospitals to put up histopathology sections. Smaller hospitals without the specimen volume can send their samples to an accredited histopath lab and not be required to set up their own, as this is counterproductive.

There is a shortage of histotechs even in the big hospitals, since their histotechs, once trained, are almost immediately hired abroad, where they are in great demand. We have to continuously train new histotechs.

By the way, those inspecting labs should also be required to have the expertise and experience in clinical labs, and not simply be bureaucratic functionaries going by the book without consideration for the proper context and settings. Oftentimes, inspectors are simply plucked from the roster of DOH employees and made to perform tasks alien to their training. That affects their evaluation of labs. Results are going to be hit-or-miss, for sure!