NIK: Reliability of information during COVID-19 outbreak called into question

Key state authorities, in assessing the course of the COVID-19 epidemic, relied mainly on positive test results, as data on incidence (clinical symptoms) was not collected as of May 2, 2020. At the same time, the Minister of Health's supervision of the provision of complete and reliable data relevant to such an assessment was ineffective. The Minister did not present specific data to the Council of Ministers to justify the introduction of various restrictions, orders and bans, e.g. on the use of forests, beaches, etc. The health ministry spent nearly PLN 54 million on building and maintaining new ICT systems, meanwhile, some of them contained incorrect records on tests, hospitalizations, vaccinations and deaths. In addition, from November 2020 until the end of the audit in July 2023. The Minister of Health did not recruit for the position of Chief Sanitary Inspector, which was crucial for public health management during the COVID-19 epidemic, points out the NIK, which decided to look into the actions taken in the COVID-19 epidemic by key state institutions responsible for public health, including: Minister of Health and Chief Sanitary Inspector. The Chamber undertook the following inspections on its own initiative:

• 1 Operation of the National Patient Registry with COVID-19 (I/22/001/KZD),
• 2 Use of information resources by the Chief Sanitary Inspector to assess sanitary risks in connection with the COVID-19 epidemic (I/22/006/KZD),
• 3 Provision and use of information resources by the Minister of Health to assess the course of the COVID-19 epidemic (I/23/001/KZD).

Minister's weak oversight of IT systems

As of March 2020, health care information systems had limited functionality or were not fully implemented. Data relevant to assessing epidemic risk were scattered across seven different systems, collected at different frequencies and in different forms: electronic and paper. The Health Ministry's response to the situation was: the introduction of electronic reporting for laboratories and the construction of four new systems: Entry Records for Poland (EWP), the National Patient Registry ICT system with COVID-19, the Vaccine Distribution System, and the central electronic registration system for COVID-19 immunization. In the initial phase (at the beginning of March 2020), the EWP system covered only people coming to Poland, then it began to collect information on all people in the country.

The NIK audit found a number of deficiencies and errors in the recorded data, especially in the case of names, GTINs and batch numbers of COVID-19 vaccines. Errors in vaccine names occurred in more than 1.6 million cases, GTINs in about 70,000, and batch numbers in about 557,000 cases in the set of vaccinations registered in the system (about 58 million entries as of June 15, 2023). Significantly, only those entries that could not be assigned to any dictionary entry for the names and numbers above were considered erroneous after digital analysis. Thus, an interpretation of the data favorable to the Minister of Health was applied. There was also unreliable information regarding, for example, inoculation or testing for COVID-19 in deceased persons. Some of the entries in the EWP system indicated that people had been admitted to or discharged from the hospital who had already been dead, even for several years. The reasons for the above anomalies, according to the NIK, included the lack of data validation at the stage of data entry into the system and the failure to introduce automatic verifications of dates in the context of the chronology of events (e.g., test ordering and execution, and the dates of test ordering, hospital admission, vaccine admission compared to the date of death). According to the Ministry of Health, there was an emphasis on recording data on tests performed even at the expense of their quality, and validations were introduced gradually (e.g., for tests - in February 2021).

The Ministry of Health had no documented analysis of the need for new ICT systems, including in terms of the possibility of using or expanding existing solutions. Meanwhile, the construction and maintenance of new systems, including the National Patient Registry with COVID-19 (KRP) and the Vaccine Distribution System (SDS), among others, cost nearly PLN 54 million. The company that developed the SDS system was selected without a documented reconnaissance of the market for software developers. According to the NIK, this was an unreliable action, increasing the risk of mismanagement.

According to the Chamber, the problem with the reliability of data in ICT systems is, on the one hand, the result of the lack of dictionaries and automatic validation of data correctness, and on the other hand, ineffective supervision by the Health Ministry in this area. The head of the Ministry of Health did not make an effort to ensure that existing IT tools provide data verification and the removal of erroneous and incomplete records, and that the process of developing new solutions is carried out in the manner prescribed by the current legislation. Such a situation adversely affected the quality of information used to counter the epidemic.

Problematic regulations

Between 2020 and 2023, the head of the Ministry of Health issued a total of 13 regulations on declaring a state of epidemic emergency and a state of epidemic in the territory of the Republic, and then revoking them. The NIK negatively assessed the Minister's issuance of six regulations without a request from the GIS. This was an action inconsistent with the Uozz.

As of May 19, 2023. The Council of Ministers issued 101 ordinances introducing restrictions, orders and bans in connection with the state of epidemic emergency and epidemic condition, such as the prohibition of the use of green areas, including parks, beaches and forest areas. In 97 cases, the Health Minister was the proposer and author of the draft regulations. The NIK audit found that the head of the Health Ministry did not provide the Council of Ministers with specific data that would reliably justify the introduction of various types of restrictions (including, among others, freedom of movement). According to the NIK, vague statements contained in the justifications for the draft regulations under review (in six of eight cases) do not constitute reliable data justifying the scope of the solutions proposed by the Council of Ministers.

National Patient Register

The Minister of Health has appointed the Stefan Cardinal Wyszynski National Institute of Cardiology - National Research Institute (NIKARD) to maintain the National Registry of Patients with COVID-19. According to the Health Ministry's estimates, the annual cost of running the registry was expected to be nearly PLN 795,000.

The audit at NIKARD showed that in 2020-2021, the Institute correctly and as intended used the funds of the targeted grant from the state budget for the establishment and operation of the NCRP. However, these funds did not guarantee that the costs of its operation were covered in full. In 2020, more than 65% of it was financed from NIKARD's own funds.

The Institute violated the provisions of the Law on Research Institutes by failing to include the received earmarked grant in the 2020 financial plan. The NIK notes that planning the use of the earmarked subsidy provided by the Minister of Health was hampered because the contract for this purpose was transferred to the Institute almost six months after the launch of the production version of the KRP, while the funds did not reach the Institute's bank account until December 2020, eight months after the launch of the registry. According to the Health Ministry, NIKARD's operating costs for the KRP were financed by the Ministry in a total amount of more than PLN 2.2 million, including more than PLN 656,000 in a targeted grant and more than PLN 1.5 million from the COVID-19 Fund.

The National Patient Registry did not contain reliable personal and medical data on patient treatment. Indeed, despite the obligation, in 2020-2021, some treatment entities did not enter data into the registry (27% and 21%, respectively). The Institute, on the other hand, did not have the appropriate tools to enforce this obligation on them.

In order to mobilize treatment entities to submit data to medical registries, the Minister of Health amended the 2015 regulation on general terms and conditions of contracts for the provision of health care services. As a result of these changes, among other things, failure to submit data to the medical registry resulted in postponement of payment, and submission of incomplete data to the medical registry was tantamount to withholding payment of dues.

On May 5, 2023, the registry was taken over by the e-Health Center.

Failure to populate GIS functions and faulty data

On November 19, 2020, Jaroslaw Pinkas, who had held the position since September 1, 2018, was dismissed from the position of Chief Sanitary Inspector. However, as of the date of completion of the audit at the Ministry of Health (July 25, 2023), no recruitment for the GIS position had been carried out. The recruitment was not announced until January 4, 2024, i.e. more than three years after the position was vacated. The position of Chief Sanitary Inspector remained vacant throughout the epidemic. In the Chamber's opinion, such a situation indicated improper supervision by the Minister of Health over this body.

The failure to fill the position of Chief Sanitary Inspector, a key position in the management of the emergency, may have negatively affected the quality of information provided by this body. GIS analyses did not include assessments and conclusions, forecasts of the development of the epidemic or recommendations for the introduction and lifting of restrictions. In addition, the conclusions submitted by the GIS to the Minister of Health in connection with the declaration of an epidemic state (dated March 2020 and December 2021) and then an epidemic emergency (dated May 2022) were not supported by analyses justifying the changes. In the Chamber's opinion, the GIS, as a specialized state body, should support the Minister of Health or the Prime Minister in decision-making, especially when it comes to introducing, maintaining, abolishing certain obligations, orders or prohibitions.

The GIS did not have data on cases of the disease, because as of May 2, 2020, the PIS authorities did not collect information on the clinical manifestations of COVID-19 (i.e., cases of the disease). As of that date, obliged persons (i.e., physicians and laboratory diagnosticians, among others) were exempted by Cabinet decree from the statutory obligation to provide reports of suspected or diagnosed COVID-19 incidence when information on the order and result of the SARS-CoV-2 coronavirus test was entered into the EWP. Data in this regard were collected, while positive results of these tests were the basis for assessing the course of the epidemic.

In explanations submitted during the inspection, the Deputy GIS indicated, among other things, that both pathological states (i.e., infection, including asymptomatic, and symptomatic, i.e., morbidity) are referred to as "infectious disease." He stated that a positive test result was the only acceptable evidence of SARS-CoV-2 infection, both in asymptomatic infected persons and in those who developed pathological symptoms (became ill), and added that clinical symptoms cannot form the basis of a diagnosis with a high degree of certainty and, as such, cannot be a rationale for restricting constitutional freedom of movement by imposing isolation that lasts until such symptoms resolve. 

The NIK stresses that the introduction of this change was not justified in any way. On the other hand, as a consequence, information on the clinical signs of COVID-19 infection did not reach the PIS authorities. Before May 2, 2020, the results of laboratory tests were reported to the competent state sanitary inspector. In the opinion of the NIK, the lack of systematic collection of data on the incidence (clinical symptoms) by the PIS meant that the ability to forecast the impact of the epidemic was limited.

In addition, in May 2020. The Prime Minister's Office proceeded with the construction of the SEPIS ICT system for the State Sanitary Inspectorate. The main objective of the project was to prevent the spread of the COVID-19 outbreak, including by enabling GIS to manage information in real time. Construction of the system was completed at the end of 2021. However, the reliability of the data in SEPIS left much to be desired, as the system did not allow for checking its accuracy and completeness. The system also did not allow the creation of reports for other entities, and the presentation of information available to the user did not include data for the entire epidemic period. In 2022, more than PLN 6 million was spent on creating the SEPIS system.

Data on adverse reactions after COVID-19 vaccination (NOP) reported by the GIS to the Chancellery was unreliable and inconsistent with data in SEPIS. The Chief Sanitary Inspector in statements to the Chancellery showed, among other things, fewer severe cases of NOP than the reports published by the National Institute of Public Health PZH - National Research Institute based on data from SEPIS. According to the NIK, the scale of the discrepancies and the lack of verification of the data in terms of completeness and quality cast doubt on the reliability of the information provided by the GIS. Despite the discrepancies found at the beginning of the epidemic in the data submitted and collected manually, and the implementation of SEPIS, manual data sets continued to be created outside the system, without using the data entered into it and without verifying their accuracy. As of May 15, 2024, such flawed information, including the revised description of a post-vaccination reaction to "redness and brief soreness at the injection site," was still available on the government website:NOP - Adverse Vaccine Reaction. What is it and how often does it occur? - Gov.pl portal.

Conclusions of the NIK

In connection with the irregularities found, the NIK made the following post-inspection requests, among others:

To the Minister of Health on:

• Documenting the analysis of existing resources and the creation of new IT solutions in terms of the needs for their implementation, as well as carrying out documented market discernment in the case of selection of a contractor outside the competitive procedures - in order to justify the decisions made, taking into account the aspect of economy in the expenditure of public funds;
• Immediate announcement of recruitment for the GIS position;
• Entering dictionaries of names, EAN (GTIN) numbers and series of vaccines distributed under the NPSz into information systems;
• Organizing the database in terms of EAN (GTIN) numbers and series of vaccines distributed under the NPSz in order to uniquely identify medicinal products administered to individual patients;
• Eliminate cases of issuing regulations without obtaining the mandatory GIS application referred to in Article 46(2) of the Law on Prevention and Control of Infectious Diseases in Humans.

To the Chief Sanitary Inspectorate (GIS) for:

• Ensure that data reporting in the subject area covered by SEPIS is carried out only on the basis of data recorded in this system, verified for timeliness, correctness, completeness, and at the same time eliminate manual reporting of data that are subject to processing in the reference ICT system, as representing not only the burden of unnecessary, duplicative activities, but also as an area of risk of errors.

Source: NIK