The National Health Surveillance Agency (Anvisa), together with the State and Municipal Health Surveillance of Rio de Janeiro and the National Transplant System (SNT), of the Ministry of Health, coordinate actions to investigate HIV contamination in six transplant patients in the State of Rio de Janeiro.
The case “is a serious occurrence”. In a note, Anvisa informed that “the priority was to monitor the recipients of the transplanted organs and determine the performance of new pre-transplant exams at the Árthur de Siqueira Cavalcanti State Institute of Hematology (Hemorio), in Rio.”
Additionally, as a preventive measure, the PCS Lab Saleme Clinical Pathology Laboratory was closed by the local Health Surveillance, with technical guidance from Anvisa, until the investigations were completed, focusing on the safety of transplants.
Anvisa also announced that investigations are ongoing involving state and municipal authorities in Rio, including Health Surveillance, the Ministry of Health and Anvisa. These institutions are working together to clarify the situation in favor of transplant safety. All related technical requirements must be strictly complied with in each phase, aiming for the health of patients and collective well-being.
Contract terminated
By means of a note, the Municipal Health Department of Nova Iguaçu (Semus) informed that the contract with the company PCS Laboratório Saleme was terminated in February this year, starting to be administered by the social organizations (OS) responsible for the basic care network of the municipality.
The contract between PCS and OS ended last Thursday (11), as soon as Semus received notification about the precautionary ban made by Anvisa in the laboratory based in Nova Iguaçu.
Semus will open an investigation. Any SUS patient who has undergone a test at PCS Saleme can return to the health unit that requested the test to request it again. To date, there is no record of patients contesting test results.
To avoid interrupting the service provided to patients who have scheduled exams, a new laboratory is being hired on an emergency basis.
Removal
Nova Iguaçu city hall also reported that doctor Walter Vieira, a licensed gynecologist in the city, is a partner in the PCS Lab Saleme laboratory. According to the city hall, Vieira held an unpaid position as president of the Steering Committee for Surveillance and Analysis of Maternal, Child and Fetal Deaths in Nova Iguaçu. Because he was one of the partners of the PCS Saleme laboratory – banned by Anvisa – the gynecologist was removed from his position this Friday (11).
The Public Ministry of the State of Rio de Janeiro (MPRJ) opened a civil investigation to investigate the irregularities reported in the transplant program in the State of Rio de Janeiro. An excerpt from the document states that, “today, numerous reports were published in the press reporting alleged contamination of six transplant patients by the HIV virus, based on false-negative tests from two donors, carried out by the Clinical Pathology laboratory. Doctor Saleme – PCS from Nova Iguaçu/RJ, hired by the Health Foundation/State Health Department in December 2023”.
The state Public Prosecutor’s Office (MP) asked the State Department of Health to send – within 15 days – a copy of the State Health Surveillance inspection report carried out at the Doutor Saleme Clinical Pathology Laboratory – PCS that led to the suspension of its activities, as well as investigations initiated based on reports of adverse events involving contamination of transplant recipients, due to false-positive results issued by the laboratory. The MP also wants Anvisa to also provide – within 15 days – a copy of the laboratory inspection report.
The civil inquiry was opened considering the public health policy that is the responsibility of the Public Ministry.
The MP clarified that the procedure is confidential, due to the involvement of sensitive patient data. And it is available to listen to affected families, receive complaints from anyone who feels aggrieved and provide individualized assistance to the parties involved. Complaints can be forwarded to the Ombudsman’s Office by form or by calling 127.
Regarding news that the Doutor Saleme Clinical Pathology Laboratory – PCS – is owned by the cousin of the former Secretary of State for Health, Dr. Luizinho, who holds a mandate as federal deputy for the PP, the Public Ministry said it will investigate the hiringforwarding the case to the Citizenship Justice prosecutors. The investigation must include the analysis of the damage caused by the service not provided properly and possible irregularities in the bidding process as a result of the aforementioned links.
Rigor in the investigation
The governor of Rio de Janeiro, Cláudio Castro, determined rigor and speed in investigations in the state’s transplant service.
In a statement, he said that “the failure of the transplant service in the state is an unacceptable and unprecedented situation. I determined total rigor and speed in the investigations. In addition to ongoing investigations at the Department of Health and the Health Foundation, the Civil Police have already opened an investigation to identify those responsible.”
Castro also said that, “from the beginning, we took all necessary measures and we will continue until the end so that this mistake never happens again. I want to ensure unrestricted support for affected transplant recipients. The State has a duty to assume its responsibility in this case.
I reiterate my commitment to preserving the safety of the state transplant system, which has already saved the lives of more than 16 thousand people”, lamented the governor.
