The Public Ministry of Rio de Janeiro is investigating the sanitary and operational conditions of the laboratory that failed HIV tests that infected six people with the virus.
The agency opened the civil investigation against PCS Lab Saleme last Friday (11) and released the information this Tuesday morning (15).
The laboratory, located in the city of Nova Iguaçu, has already been closed by the Subsecretariat of Surveillance and Primary Health Care of the State Department of Health (SES-RJ).
The inquiry states that the investigation is necessary “to to determine whether the operation of the Saleme Laboratory is in accordance with the technical parameters, health standards and operational procedures that guide the performance of clinical and pathological analyses”.
The Public Prosecutor’s Office emphasizes that it is urgent to check whether the laboratory was contracted by other institutions or public bodies, which carry out laboratory tests with the company.
From this point on, the Prosecutor’s Office will determine the suspension of PCS Lab services with these institutions, until the failures in the exams prior to organ transplants are fully investigated.
The MPRJ has already issued a letter asking the company to stop providing services to UPAs Austin, Comendador Soares and Vila de Cava. Exams should not be carried out until the end of the investigations.
The ministry also requested that the Municipal Health Secretary of Nova Iguaçu forward documents and information within 10 days.
The civil investigation was initiated by the 1st Public Prosecutor’s Office for Collective Health Protection in Metropolitan Region I.
In addition to this investigation, the MPRJ also investigates the infection of patients with HIV, the alleged irregularities in the RJ transplant program and recommended that the SES-RJ improve conduct in the analysis of blood samples at the State Transplant Center (CET).
Read the PCS Lab Saleme position note below:
In a statement to the police today, Walter Viera, one of the partners at PCS Lab Saleme, stated that the preliminary result made by the laboratory’s internal investigation points to evidence of human error in the transcription of the results of two HIV tests.
His and Mateus Vieira’s defense vehemently repudiates the insinuation that there was a criminal scheme to forge reports in the laboratory, which has been operating in the market since 1969. The defense is confident that, after the clarifications provided by Walter, the Court will find it unnecessary to keep him arrested.
Matheus voluntarily presented himself and was released. He assured the authorities that he will testify when his defense has full access to the investigation files.
In relation to Jacqueline Iris Bacellar de Assis, PCS Lab clarifies that she presented unsuitable documentation (biomedical diploma and professional card with qualifications in pathology), inducing the laboratory to believe that she was competent to sign reports.
In the last 12 months, PCS Lab Saleme has performed more than 3 million exams. Since December 1st, when it began providing services to the Health Foundation of the Government of the State of Rio de Janeiro, the laboratory has purchased at least 900 tests to diagnose HIV in blood samples from organ donors, following recommendations from the Ministry of Health and the Anvisa.
As reported by the press, of the 286 samples submitted for new testing at HemoRio, 205 were negative for HIV, confirming the PCS Lab reports.
The laboratory reaffirms that it will provide all necessary support to the victims as soon as it has official access to their identities; and which is available to the authorities investigating the case.
Remember the case
Six patients were infected with the HIV virus after undergoing organ transplants in Rio de Janeiro. The tests of two organ donors were false negative, which resulted in the unprecedented case.
The laboratory responsible for the tests, PCS Lab Saleme, admitted signs of human error in the procedures, and is being investigated by the Civil Police of RJ, the Public Ministry of RJ, the Government of Rio de Janeiro and the Federal Police.
The laboratory was hired by the State Department of Health to test organ donors. The contract, signed by Fundação Saúde do RJ in December 2023, lasted 12 months and had a total value of more than R$11 million.
According to the CNN those infected are already aware and organs from another 288 donors are undergoing new testing in the state.
It is the first time that something like this has occurred in Brazil. In Rio de Janeiro alone, 16 thousand people have undergone transplants since 2006.
The laboratory contracted to carry out the test on donors had its contract suspended, and new tests will be carried out by Hemorio.
According to the Civil Police, the cases were caused by operational failure with the aim of making a profit. The statement is from the Civil Police Secretary, Delegate Felipe Curi.
This content was originally published in MP investigates sanitary conditions in laboratory that failed HIV tests in RJ on the CNN Brasil website.
Source: CNN Brasil
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