Doctor uncovers misdiagnosis given to 800 women with uterine lesions

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In February 2021, a woman had a Pap smear performed at the Ebáis in her community. On the 11th of that month, the sample was analyzed at the National Cytology Center (CNC). The result was reported as normal and the insured was so informed.

Three months later, on May 14, the same sample was tested, with a dramatically different result: It had adenocarcinoma, a type of cervical cancer.

In the following two months, the situation was repeated with two other women, who were initially not found to have any problems and, after a second check-up, carried out three to four months later, it was determined that they had the same tumor.

Although there is no name for any of them, the cases are real and they are not the only ones. Just over 800 women received favorable reports from their pap smear and, after several months, were informed that there had been an error, since they did present lesions of varying severity in the uterus.

In this way, 15 cases of possible carcinomas were discovered. The samples from those patients were first analyzed between June 2019 and August 2021, but it was not until the second study that the problem was detected. In these cases, the fastest review took only one day. One lasted a year and a month. Another, year and four months.

Added to the list are 42 high-grade injuries and 755 low-grade injuries in samples that entered the CNE for the first time between April 2019 and September 2021; they were rescreened between May 2019 and March 2022.

815 undetected injuries

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These hundreds of erroneous diagnoses were denounced by Álvaro Echeverría, a doctor at the National Cytology Center itself, in a document that he delivered to the Internal Audit of the Costa Rican Social Security Fund (CCSS), on July 4, and of which he has a copy. The nation.

Until now, no Audit visits, interviews or analyzes have been carried out, despite the fact that for some patients this could imply lost time for the care of their illness.

In the case of the three patients with carcinoma, for example, the regulations of the Fund establish that no later than eight days after diagnosis they must undergo a colposcopy, a more rigorous examination that determines the stage of the disease to make decisions about treatment. .

“Adenocarcinomas are easily seen in a trained eye. This is seen by people who studied who are supposed to at least ask the pathologist for a review,” Echeverría said.

Meanwhile, women with possible carcinomas ran the risk that the large lesion could have evolved in a year and four months, which was the time that elapsed before the correct diagnosis was given. In these situations, colposcopy should be performed 30 days after diagnosis.

For Rodrigo Álvarez Ramírez, director of the National Cytology Center, these numbers of erroneous diagnoses respond “to quality control” carried out by the institution. He thus stated it when consulted by La Nación.

Arrangements were made to talk with the medical manager of the CCSS, Rándall Álvarez, and the entity’s auditor, Ólger Sánchez, but in neither case was the request heeded.

an unknown number

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One of the concerns of the complaining physician is that only a percentage of these samples will be rescreened, so what could have happened to those that did not undergo that second review. Will there be any with a large injury whose result has been given as normal? How much could a lesion grow without being treated until the woman’s next cytology?

Lesions can be treated before they turn into cancer, and the earlier the stage, the easier this procedure will be. However, if this is not done, the risk of developing malignant tumors is greater.

Added to this is another factor: this cancer does not give symptoms until it has already evolved a certain way and it could be too late.

In our country, approximately 320 cervical tumors are detected each year and some 140 women die from this cause, according to data from the National Tumor Registry and the National Institute of Statistics and Censuses (INEC).

‘This responds to quality control’

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The director of the CNC, Rodrigo Álvarez, recalled that international regulations indicate that at least 10% of the samples taken for cytology must be reviewed again. However, he indicated that since the pandemic forced these tests to be stopped for months, it was decided to do second reviews of all the tests that arrived.

“We left a year and a half ago. She sifted through what she had stored. Adding up the numbers, these lesions do not even represent 0.2% of the samples (…)”, asserted the doctor, for whom the discovery of the error was the product of “quality control”.

What has happened in these cases? Perhaps we are being efficient, it may be. That it was passed (the sample) to another person (for analysis) and then the accurate result would be obtained, thanks to quality control, ”he said.

“I understand the anguish for the woman. Let’s put the worst case scenario, that she turned out normal and it turned out to be cancer. But what would be worse? Let it evolve for a year or two and let it come to me with invasive cancer, or die? The system fulfilled its objective, to find people at risk,” she added.

Álvarez, who is a pathologist, indicated that quality control begins with the taking of the sample in the Ebáis, a procedure that the CNC does not have under its control.

“If it is badly taken, badly fixed, if it comes from there badly, it can give us a negative. It also depends on who saw the test. Sometimes new people come who have to be retrained from scratch. Or sometimes the best is the newest“, highlighted Álvarez.

How does the CNC work?

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International recommendations indicate that sexually active women should have a Pap smear once a year and not space them more than two apart.

In the Ebais, a piece of tissue is taken from the uterus and it is sent to the CNC for analysis. Samples of women from all over the country are studied there, except for Pérez Zeledón, where they have their own laboratory, according to Álvaro Echeverría.

At the CNC, specialists called cytotechnologists search the samples for evidence of lesions caused by the human papillomavirus (the main agent of cervical cancer). About 1,500 are received per day, although with the pandemic this number decreased “considerably”, since the levels prior to the health emergency have not yet been reached.

If anything suspicious is found, it is further analyzed by pathologists and, if confirmed, a notification is sent immediately to contact the woman and have her treated based on the type of injury she has.

When the pandemic arrived, teleworking began, according to Álvaro Echeverría, a doctor who reported the cytology problem to the Internal Audit of the CCSS. The 47 cytotechnologists took work per week and when they finished they left it in the CNC. According to his complaint, that lowered the quality controls.

The exam and the cancer in question

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A cytology is not the most reliable test to determine cervical lesions, and for this reason it is advisable to perform it frequently, so that what was not seen on one occasion can be seen the following year or two, or even three years. To understand we must be clear about two terms: sensitivity and specificity.

Sensitivity: The probability of a test to detect an infection in a person who does have the infection. In other words, the higher the sensitivity, the lower the risk that a negative result will be false (false negatives).

Specificity: The probability of a test ruling out an infection when you don’t have one. That is, to correctly identify healthy cases. In other words, the higher the specificity, the lower the risk that a positive result will be false (false positives).

The test seeks to determine if the cervix has lesions caused by the human papillomavirus (HPV). HPV is a sexually transmitted microorganism. Thirteen of its 150 types can infect cells of the cervix. A person could carry HPV without knowing it and, through different sexual practices, infect their partners.

Almost always, the human body fights the infection and clears it on its own. In these cases, the individual is not even aware that they had an infection, but sometimes lesions form that, over the years and if not treated, lead to cancer.

The papanicolau, then, seeks to follow up on the woman.

According to Álvarez, the sensitivity of a Pap smear is close to 50%. In other words, a “normal” result has a 50% chance of actually hiding a lesion that was not seen. The advantage is that the lesions usually evolve very slowly before reaching cancer, which allows them to be “captured” in subsequent tests.

However, Echeverría is emphatic that what was found in those reviews was too obvious for it to be rescreened.

“You see these sheets and you can’t let them go. It is to notify the pathologist to review them. Even the smallest and most minor injuries can be seen again. Although they are not fatal, the sooner they are detected, the better,” Echeverría stressed.

To future

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In recent years, efforts have been made to migrate towards tests that, instead of detecting a lesion caused by the virus, look directly for HPV. This is done mainly at the private level and in specific social security centers in the central Pacific and in Guanacaste where projects are carried out.

The advantages of this method are that the sensitivity is greater than 80% and it helps to detect early infections; even some more modern ones have a greater effectiveness. However, Álvarez warned that the perfect test does not exist, since the human component makes errors possible.

When will the test for the human papillomavirus be available throughout the country? The first step is to expand to the areas of Guanacaste and Puntarenas where it had not been reached. Then cover the whole country.

There are no dates for this, it depends on the requirements of the CCSS and the indications given by the Medical Management.