Larkin Community Hospital, Inc.

MIAMI, June 25, 2024 /PRNewswire/ -- Larkin Community Hospital Palm Springs Campus (LCHPSC) announced the opening of a new cardiac catheterization lab that will provide rapid and comprehensive care to hundreds of heart patients every year for life-threatening emergencies and scheduled cardiac procedures. The cardiac catheterization lab, will transform treatment for patients in the growing community of Hialeah by vastly improving access to cardiac care in the surrounding area. Dr. Brian Valle, has been named the Director of the LCHPSC Catheterization Lab and leads a team of twenty specialists including interventional cardiologists, nurses, and technicians. The hospital's interventional cardiologist are some of the most experienced in Miami Dade County. "Our team is thrilled that LCHPSC will now be a destination for world class cardiac care, by offering the advanced cardiac services of elective and emergency coronary intervention 24 hours a day, 7 days a week," explains Dr. Brian Valle. A catheterization lab or "cath lab" is critical for treating heart attack patients whose artery suddenly becomes blocked, leading to loss of blood flow in the heart muscle. They require an urgent, minimally invasive stenting procedure called percutaneous coronary intervention (PCI) that is performed in the cath lab. The stent serves as a scaffold to open the blocked artery and restores blood flow to preserve heart muscle function; otherwise, the heart may be permanently damaged. The life-saving and usually painless stenting procedure offers a quick recovery and return home, and improves a patient's quality of life. The LCHPSC Catheterization Laboratory also provides a variety of elective procedures for hundreds of additional heart patients. These include stenting for severely blocked coronary arteries that cause chest pain or shortness of breath; catheterizations to measure function in heart failure patients to better manage their symptoms; and implanting pacemakers and defibrillators in patients with abnormal heart rhythms. The experienced cardiac team at LCHPSC can also take care of STEMI patients. STEMI which stands for ST-Elevation Myocardial Infarction, is a serious heart attack caused by lack of blood flow to large areas of the heart. Our STEMI team is composed of Techs, Nurses, and Doctors all with extensive years of treating these complicated STEMI patients. Patients experiencing these critical types of heart attacks can get potentially lifesaving care by re-opening blocked arteries in less than 90 minutes, which is the national standard. "Larkin Community Hospital Palm Springs Campus has made significant strides in enhancing its cardiac care services. By expanding its Cardiology Division to include a full-service catheterization laboratory and taking care of STEMI patients, the hospital is equipped with advanced technology and highly trained staff to promptly diagnose and treat heart attack patients," says Yoely Hernandez, CEO at Larkin Community Hospital Palm Springs Campus. "This accomplishment not only demonstrates the institution's commitment to providing quality healthcare but also showcases its resilience in bouncing back from the challenges posed by the pandemic, especially in a city like Hialeah, which was hit particularly hard. It's indeed a remarkable achievement that reflects the dedication and efforts of everyone involved in our Hospital." SOURCE Larkin Community Hospital Palm Springs

The US Government Accountability Office has made four recommendations to the FDA and HHS to improve their oversight of institutional review boards’ (IRBs) own inspections of research studies, according to a new report . IRBs are meant to keep a sharp eye on the ethics and safety of research studies involving human patients, from behavioral studies to clinical trials, including overseeing overall conduct and maintaining data integrity. The FDA and the HHS’ Office for Human Research Protections (OHRP) oversees IRBs using either routine or for-cause inspections to make sure the IRBs, in turn, are following federal laws when they’re reviewing research that involves humans. The issue with the current system, according to the GAO, is that “few” of the 2,300 US-based IRBs are inspected by the HHS and FDA each year. The agencies also lack self-reflection, the GAO says in its report — the agencies haven’t taken a look at themselves to see if they are doing the necessary number of inspections or if how inspections are done should be changed to reduce risks to patients during trials. OHRP’s “aim” is to do three or four IRB routine inspections each year and the FDA has done, on average, 133 inspections annually between fiscal years 2010 and 2021. That might not be enough, according to the GAO. Neither agency is doing internal reviews to make sure that their work overseeing the IRBs is effective, with the report adding that “Such an approach would be consistent with federal risk management principles.” The GAO made three recommendations for HHS, including that the assistant secretary for HHS should make sure that protocol data collected in OHRP’s IRB registry are accurate and ensure that the OHRP conducts an annual risk assessment to determine whether the agency is doing enough routine IRB inspections. The secretary of HHS should make sure that the FDA and HHS look at whether the IRB is effective in protecting human patients by bringing together multiple stakeholders and potentially implement effectiveness measures or peer audits of IRB meetings and decisions, according to the GAO. The FDA is also included in the recommendations — the GAO says the FDA commissioner should conduct a risk assessment annually to make sure the agency is inspecting IRBs frequently enough. Just last month, the FDA warned an IRB in South Florida after the agency found the Larkin Community Hospital Institutional Review Board went against requirements by reviewing and approving research at meetings that did not have a majority of members present.

An institutional review board (IRB) for a hospital in South Florida has been hit with a warning letter from the FDA over concerns raised during an inspection late in 2021. The letter , sent earlier this month to Sima Marzban, the VP of research and academic affairs for the Larkin Community Hospital Institutional Review Board, states that an inspection was conducted in November to see if the hospital’s human studies complied with FDA requirements. The site was issued a Form ‘483, however, investigators noticed after reviewing the IRB’s response that it “did not adhere to applicable statutory requirements” that govern the protection of human subjects. Specifically, investigators took issue with how the IRB reviewed proposed research. The agency accused the IRB of reviewing and approving research at meetings in which a majority of members (including one “nonscientist”) were not present, going against requirements. In the response to the FDA, the IRB promised it would take steps to correct this, but the agency wasn’t completely satisfied. “We are unable to perform an informed evaluation of the IRB’s written response because you did not provide a corrective action plan that, if properly carried out, would prevent the recurrence of this type of violation in the future. Specifically, you did not provide sufficient details on the procedures you are initiating and how you will ensure that a majority of the IRB members, including at least one member whose primary concerns are in nonscientific areas, will be present at convened meetings when proposed FDA-regulated research is under review,” the letter said. The letter also said that the IRB did not maintain documentation of its activities, including a list of current members, and that it had failed to ensure its process for providing patients with information as a part of informed consent was up to code. More specifically, investigators accused the IRB of failing to make sure that the informed consent documents for two clinical trials contained a statement notifying the patient that their trial information “has been or will be submitted for including in the clinical trial registry databank.” The response to the FDA did note that “actions were in motion to establish best practices” and that future trial documents would include the statement. However, the letter notes that the response did not include an action plan for preventing the recurrence of this violation in the future. “Specifically, you did not provide sufficient details on the best practices you are establishing and how you will ensure that the ICDs will contain the statement,” the letter said. Endpoints News reached out to Larkin Community Hospital, but did not receive a response by press time.