VARISOURCE IX

Description of Event or Problem

(B)(6), MSC, QMP ASSISTANT HOSPITAL RADIATION PHYSICIST (B)(6) CANCER CENTER , (B)(6) MEDICAL CENTER. DECEMBER 31, 2024, DR. (B)(6) DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) U.S. FOOD AND DRUG ADMINISTRATION (B)(4). DEAR DR. (B)(6), I AM (B)(6), AN ASSISTANT HOSPITAL RADIATION PHYSICIST AT THE (B)(6) CANCER CENTER. I AM WRITING TO FORMALLY REQUEST THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) INVESTIGATE A CRITICAL COMPLIANCE AND PATIENT SAFETY ISSUE THAT OCCURRED ON (B)(6) 2022, WITHIN THE RADIATION ONCOLOGY DEPARTMENT AT (B)(6) MEDICAL CENTER. THIS INCIDENT INVOLVES THE FAILURE TO PERFORM MANDATORY PRE-TREATMENT SAFETY CHECKS ON A HIGH-DOSE-RATE (HDR) BRACHYTHERAPY SYSTEM, FOLLOWED BY THE FALSIFICATION OF RELATED DOCUMENTATION. INCIDENT OVERVIEW ON (B)(6) 2022, A CANCER PATIENT AT (B)(6) WAS TREATED USING THE VARISOURCE IX AFTERLOADER (SERIAL NUMBER (B)(6)), A HIGH-DOSE-RATE REMOTE AFTERLOADING SYSTEM USED TO DELIVER BRACHYTHERAPY TREATMENT. AS PART OF ESTABLISHED SAFETY PROTOCOLS, INCLUDING ADHERENCE TO 10 CFR 35, WHICH IS REGULATED BY THE NUCLEAR REGULATORY COMMISSION (NRC) AND THE (B)(4) RADIOLOGICAL HEALTH BRANCH, MANDATORY PRE-TREATMENT SAFETY CHECKS MUST BE PERFORMED AND DOCUMENTED BEFORE USE. HOWEVER, DURING AN AUDIT ON NOVEMBER 23, 2022, DR. (B)(6) AND I DISCOVERED THAT NO PRE-TREATMENT SAFETY CHECKS HAD BEEN CONDUCTED ON (B)(6) 2022. THE SYSTEM'S CONSOLE SHOWED NO ENTRIES FOR THAT DATE, INDICATING THAT THE REQUIRED CHECKS WERE NOT LOGGED. DESPITE THIS, DR. (B)(6) PHD, WHO WAS COVERING THE SERVICE ON THAT DAY, FALSIFIED THE RECORDS BY SIGNING AND DATING THE PRE-TREATMENT QA DOCUMENTATION, FALSELY INDICATING THAT THE SAFETY CHECKS HAD BEEN COMPLETED. KEY ISSUES THIS SITUATION RAISES SEVERAL CRITICAL CONCERNS: 1. DERELICTION OF DUTY: THE FAILURE TO COMPLETE THE MANDATED PRE-TREATMENT SAFETY CHECKS CONSTITUTES A SIGNIFICANT BREACH OF RESPONSIBILITY BY THE PERSONNEL INVOLVED, DIRECTLY JEOPARDIZING PATIENT SAFETY. 2. ENDANGERMENT OF PATIENT SAFETY: FAILING TO PERFORM THE NECESSARY SAFETY CHECKS BEFORE USING A HIGH-ACTIVITY RADIATION SOURCE POSES A SIGNIFICANT RISK TO THE PATIENT, POTENTIALLY EXPOSING THEM TO MALFUNCTIONS OR IMPROPER FUNCTIONING OF THE TREATMENT EQUIPMENT. 3. FALSIFICATION OF RECORDS: DR. (B)(6) SIGNED DOCUMENTATION FALSELY INDICATING THAT THE PRE-TREATMENT SAFETY CHECKS WERE CONDUCTED, DESPITE NO EVIDENCE THAT THE CHECKS WERE PERFORMED OR THAT HE EVEN LOGGED INTO THE SYSTEM ON THE DATE IN QUESTION. ACTIONS TAKEN UPON DISCOVERING THE DISCREPANCY, DR. (B)(6) AND I IMMEDIATELY REPORTED THE INCIDENT TO (B)(6) RADIATION ONCOLOGY DEPARTMENT LEADERSHIP, INCLUDING DR. (B)(6) (CHAIR) AND DR. (B)(6) (VICE-CHAIR), IN NOVEMBER 2022. I ALSO ADDRESSED THE ISSUE DIRECTLY WITH DR. (B)(6) ON JANUARY 5, 2023. DESPITE THESE EFFORTS, NO IMMEDIATE CORRECTIVE ACTIONS WERE TAKEN. IN RESPONSE, DR. (B)(6) ESCALATED THE MATTER TO THE (B)(6) COMPLIANCE OFFICE IN APRIL 2023. UNFORTUNATELY, NO MEANINGFUL RESPONSE WAS RECEIVED UNTIL MUCH LATER THAT YEAR. GIVEN THE LACK OF RESPONSE, DR. (B)(6) AND I CONTINUED TO PURSUE FURTHER AVENUES, INCLUDING REPORTING THE ISSUE TO THE (B)(6) RADIATION SAFETY OFFICER AND THE (B)(6) OFFICE OF THE PRESIDENT. DESPITE THESE ONGOING EFFORTS, THE INVESTIGATION AND NECESSARY CORRECTIVE ACTIONS WERE DELAYED FOR AN EXTENDED PERIOD. PART 1. WHISTLEBLOWER RETALIATION IN ADDITION TO THE GRAVE PATIENT SAFETY CONCERNS, I MUST REPORT INSTANCES OF RETALIATION FOLLOWING OUR ATTEMPTS TO REPORT THESE ISSUES. DR. (B)(6) WAS PLACED ON INDEFINITE LEAVE AND FACED UNDUE PROFESSIONAL CHALLENGES. MOREOVER, DESPITE THE SUBSTANTIATED ALLEGATIONS AGAINST HIM, DR. (B)(6) WAS PROMOTED TO INTERIM VICE-CHAIR OF THE (B)(6) MEDICAL PHYSICS DEPARTMENT. THIS RAISES SERIOUS CONCERNS ABOUT THE LACK OF ACCOUNTABILITY WITHIN THE DEPARTMENT. REGULATORY REPORTING THIS INCIDENT HAS BEEN REPORTED TO SEVERAL REGULATORY AGENCIES, INCLUDING THE NRC AND THE (B)(6) DEPARTMENT OF PUBLIC HEALTH'S RADIOLOGIC HEALTH BRANCH, DUE TO THE INVOLVEMENT OF HIGH-RISK RADIATION PROCEDURES AND THE FAILURE TO FOLLOW SAFETY PROTOCOLS. THE ISSUE REMAINS A SIGNIFICANT CONCERN, ESPECIALLY GIVEN THE POTENTIAL RISKS TO PATIENT POPULATIONS UNDER (B)(6), CMS, AND THE VETERAN'S ADMINISTRATION, WHICH ARE COVERED BY BOTH STATE AND FEDERAL REGULATIONS. PART 2 (CONTINUATION OF PART 1). CONCLUSION; THE FAILURE TO ADHERE TO SAFETY PROTOCOLS, FALSIFICATION OF RECORDS, AND RETALIATION AGAINST THOSE WHO ATTEMPTED TO REPORT THESE ISSUES REPRESENT A SERIOUS BREACH OF ETHICAL STANDARDS AND PATIENT SAFETY REGULATIONS. FURTHERMORE, THE LACK OF A TIMELY AND ADEQUATE RESPONSE FROM (B)(6) LEADERSHIP HAS EXACERBATED THE SITUATION. THEREFORE, I AM FORMALLY SUBMITTING THIS REPORT IN THE HOPE THAT THE FDA WILL CONDUCT A THOROUGH INVESTIGATION INTO THIS MATTER TO ENSURE THE SAFETY OF PATIENTS AND THE INTEGRITY OF MEDICAL PRACTICES WITHIN (B)(6) RADIATION ONCOLOGY DEPARTMENT. I HAVE ATTACHED RELEVANT DOCUMENTATION, INCLUDING SYSTEM SNAPSHOTS, QA FORMS, AND COPIES OF (B)(6) POLICIES AND PROCEDURES PERTAINING TO THIS ISSUE. BOTH INCIDENTS HAVE BEEN REPORTED TO THE APPROPRIATE NRC AND CDPH-RHB REGULATORY AGENCIES, THOUGH I HAVE YET TO RECEIVE ANY FEEDBACK OR UPDATES. WHILE THIS MAY BE DUE TO THE HOLIDAY SEASON, I AM CONCERNED THAT IT MAY ALSO BE LINKED TO A POTENTIAL CONFLICT OF INTEREST INVOLVING (B)(6), (B)(6) RADIATION SAFETY OFFICER, A FORMER EMPLOYEE OF THE (B)(6) DEPARTMENT OF PUBLIC HEALTH (RADIOLOGIC HEALTH BRANCH) AND THE NUCLEAR REGULATORY COMMISSION, AND HER OVERSIGHT OF RADIOACTIVE MATERIAL HANDLING IN (B)(6) REGION. AUTHORIZATION I WANT TO EXPRESS MY FULL AUTHORIZATION FOR THE FDA TO REVEAL MY IDENTITY AS PART OF THIS INVESTIGATION, AS I BELIEVE IT IS ESSENTIAL TO ENSURE ACCOUNTABILITY AND ADDRESS THIS MATTER COMPREHENSIVELY. PLEASE DON'T HESITATE TO CONTACT ME IF YOU HAVE ANY QUESTIONS OR NEED ADDITIONAL INFORMATION AT (B)(6). I TRUST THAT THE FDA WILL PRIORITIZE AN INVESTIGATION INTO THIS MATTER AND TAKE APPROPRIATE ACTIONS TO SAFEGUARD PATIENT WELFARE. SINCERELY, (B)(6), MSC ASSISTANT HOSPITAL RADIATION PHYSICIST (B)(6) CANCER CENTER. PART 3 (CONTINUATION OF PART 2).