Inspectors find non-compliance with vaccination strategy at six institutions

Ljubljana – A report by the health inspectorate about compliance with the national vaccination strategy shows that the national strategy was not fully complied with in the vaccination of 297 persons at six health institutions. The Oncology Institute in Ljubljana stands out. The institutions say they have not received detailed instructions.

Due to suspicion that some institutions do not comply with the national vaccination strategy, following media reports suggesting that elderly relatives of staff were being vaccinated when there were not enough patients or staff to use up all the available vaccine, the Health Inspectorate visited 20 vaccination points and the Oncology Institute between 27 December and 16 January.

Inspectors were checking how many shots individual vaccination points requested, how many they received, how many people were inoculated, the structure of the persons vaccinated, and whether data are being entered into the e-register of vaccinated persons and reported side effects.

Inspectors found that in 14,144 cases the vaccination was conducted in line with the rules. But in 297 it was not. In most cases, individuals who were not on the priority list were vaccinated with the sixth dosage, obtained from the multidose vial of the Pfizer/BioNTech vaccine that needs to be diluted before use, as initially a bottle of the vaccine was registered for only five doses.

In the six institutions, the sixth dosage was administered to persons who are not medical staff, care home staff or older people but the staff’s relatives, partners or friends. The institutions responded by saying they had not received instruction on how to use the sixth dosage of the vaccine.

Such irregularities were happening until 20 January, but since then institutions are obligated to use all six dosages of the vaccine, Deana Potza from the Health Inspectorate told the press today.

The European Medicine Agency updated its guidelines on the use of the vaccine on 8 January, saying six and not just five shots should be obtained from a single vial.

According to Potza, a decree was issued when irregularities were detected, saying the vaccination must be used in line with the national strategy, and that the sixth dosage must be used for those first in line for vaccination.

The most irregularities were detected at the Oncology Institute, followed by the Velenje, Grosuplje and Domžale community health centres and the Jesenice and Nova Gorica general hospitals.

Responding to the report, the Oncology Institute said it had used all doses ordered and received for its staff. But since the sixth dose was also obtained from the bottle it had been offered to the closest relatives of the staff.

“Experts believe the Oncology Institute is an extremely vulnerable institutions in the Covid-19 epidemic because of the nature of the disease and treatment of our patients. Moreover, our data show that most infections among staff comes from their home environment,” the institute said.

The head of the Velenje centre, Janko Šteharnik told the STA the national strategy had been respected. He said in the first round of vaccination the instruction had been not to use the sixth dose, but the centre had decided to use it nevertheless. He said a large majority of those vaccinated with the sixth dose were older than 60.

The Jesenice hospital said first the staff had been invited to get inoculated but when not all of them responded, staff from the list for the second round had been invited. This happened at the beginning of the month, so other candidates who expressed interest were invited – retired medical staff, medical staff from other institutions and a few relatives of the staff.

Štefka Zaviršek from the Grosuplje community health centre said the instruction had not been precise enough, so all its staff, including technical staff, had been vaccinated. The list of candidates also had to be expanded at the last minute, as the centre had been informed it must use all six doses on the day of the vaccination. All persons added to the list were patients with chronic diseases but not all of them were older then 80, Zaviršek said.

The Domžale centre would not comment, as it had not received a decision of the Health Inspectorate yet.

The Ljubljana Medical Faculty, which confirmed for the STA to have vaccinated people who are not its staff, was not inspected, as it had not been on the list of vaccination points. But because of media questions about vaccination there, an inspection will be carried out, Potza said.

This week, inspectors visited 15 vaccination points to find that family members of staff and other individuals who are not yet eligible for vaccination were being vaccinated at three points.

Inspectors have also found that the data entered in the e-register in the last few weeks were incomplete in 86% of the cases. They proposed that institutions be obligated to enter data on vaccination within 24 hours after the inoculation.