Northern Westchester Hospital

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 17636 Based on medical record review, document review and interview, in one (1) of 20 medical records reviewed, it was determined the facility failed to (a) implement methods to prevent and control the transmission of infections within the hospital and between the hospital and other settings and (b) collaborate with the quality assessment performance improvement program on infection prevention and control issues. This was evident for MR #1. This failure placed patients, visitors, and staff at the hospital and members of the community at risk for contracting a reportable airborne communicable disease. Findings include: The facility failed to identify and appropriately screen a patient who had symptoms of a Tuberculosis infection when the patient was in the emergency department on 2/26/23 and 10/21/23 and (b) screen in a timely manner, patient(s), staff, and visitors who were exposed to a patient who had symptoms of a Tuberculosis infection. See findings at A 0749. The facility failed to ensure that the infection control program collaborated with the quality assessment performance improvement program to control the exposure and spread of the infection in the hospital and the community. See findings at A 0774.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 17636 Based on interview and document review, in one (1) of eight (8) incidents reviewed, it was determined the facility failed to conduct a complete investigation in a timely manner of a complaint related to a patient discharged from the facility who had Tuberculosis. Findings include: The document titled “Performance Improvement/Patient Safety Plan, 2023-2024” states, “In order to identify the factors that underlie or contribute to the undesirable variation in performance, the organization shall conduct a Root Cause Analysis (RCA). The multi-disciplinary RCA team is charged with analysis of the single event, identification of contributing factors, and the development of a root cause statement that when reliably corrected, will decrease the likelihood of a similar event. Additionally, cultural components, environmental and cognitive factors impacting the event shall be incorporated into the analysis.” Review of the incident log for 2023 revealed there was no data related to a complaint of patient discharged from the facility who had Tuberculosis. During an interview conducted on 11/30/23 at 9:55 AM with Staff A, Program Director Infection Prevention Committee, Staff A stated that a nurse from the County Department of Health (DOH) alleged during a phone call on 10/27/23, that a patient (MR #1) was treated and released from Northern Westchester Hospital with a communicable reportable disease (Tuberculosis) without the facility notifying the County Department of Health as required by New York State Public Health law. Staff A stated she sent an email that day (10/27/23) to the Director, Chief Medical Officer, the Infectious Disease Medical Doctor, Director of the Emergency Department, and the Director of Nursing in the Emergency Department. Staff A acknowledged that she had not taken any further action and that a root cause analysis would be done on 12/6/23. There was no evidence that the facility completed a root cause analysis to identify the issues and implement corrective actions to prevent recurrence. These findings were shared with Staff C, Director of Regulatory Affairs on 12/4/23 at approximately 3:15 PM.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 17636 Based on medical record review, document review and interview, in one (1) of 20 medical records reviewed, it was determined the facility failed to identify and screen staff, patients and visitors who were potentially exposed to an airborne reportable communicable disease. This was evident in MR #1. Findings include: The policy titled “Tuberculosis Screening, Repeat Testing, and Management of Occupational Exposures,” approved 6/2/22, states “When an individual meets the high or moderate risk category, they need post-exposure TB screening when not wearing an N95 respirator. High risk Health Care Personnel (HCP) individuals with the highest risk of transmission of M. tuberculosis perform the following activities for any duration of time such as: (4) induce sputum or other cough-generating procedures, and for moderate risk HCP: HCP who are directly involved in patient care or close patient contact. When an individual meets the moderate risk category, they need post-exposure Tuberculosis screening. This category includes HCP who are not performing aerosolizing procedures, but are assigned to the patient’s care area, (i.e., room or designated location when it is an open ward) and have close, direct patient contact for greater than: at least one (1) hour of cumulative exposure when the patient is smear positive for M. tuberculosis.” Review of MR #1 revealed this 73 year-old patient presented to the Emergency Department (ED) on 2/26/23 at 2:13 PM with complaints of cough x 2 months, not eating and weight loss. A significant finding was the chest x-ray read at 3:39 PM showed there was “mild to moderate perihilar infiltrates and patchy consolidation/atelectasis/effusion at the right base evident. Impression: mild to moderate perihilar interstitial infiltrates bilaterally. Patchy consolidation/atelectasis/effusion at the right base.” The patient was diagnosed with Pneumonia and discharged from the Emergency Department at 5:48 PM, more than three (3) hours after he arrived in the Emergency Department. The patient returned to the Emergency Department on 10/21/23 at 3:47 PM with hemoptysis x 2 days. The significant finding was a CT-Scan of the chest was performed and the radiologist noted at 8:03 PM “diffuse bronchiectasis. Extensive consolidative changes in the right lower lobe with multifocal areas of cavitating nodularity some of which communicates with the adjacent bronchus as well as innumerable nodular densities throughout the lung fields, right lung greater than the left, may represent extensive infectious or inflammatory etiology however neoplastic etiology cannot be ruled out.” The Emergency Department doctor documented at 8:15 PM that a CT-Scan of the chest showed “the patient has extensive consolidative changes and numerous cavitating nodules some of which communicate with the adjacent bronchus which likely explains hemoptysis.” The doctor also documented a message was sent to the radiologist to ask if the imaging is consistent with Pulmonary Tuberculosis. The radiologist documented an addendum note at 8:20 PM which indicated “Differential diagnosis includes fungal infection and Tuberculosis cannot be excluded.” The Emergency Department doctor documented “Sputum tests to include culture, fungal infection and AFB (acid fast bacilli for Tuberculosis detection) culture were ordered; however, patient is having difficulty producing sputum for the test. Will allow an additional 20 minutes or so for patient to attempt to produce some sputum, otherwise these tests will need to be performed in the outpatient setting.” The patient was discharged from the Emergency Department at 9:27 PM, almost six (6) hours after arrival to the facility. There was no evidence that airborne, or isolation precautions were implemented throughout either of the patient’s Emergency Department visits. The survey team arrived at the facility on 11/29/23 and notified the facility that the team would be conducting a survey for the Condition of Participation for Infection Prevention and Control and Antibiotic Stewardship Program. The following day, 11/30/23 at 10:11 AM, the Chief Medical Officer confirmed the facility’s failure to identify and report to the Department of Health MR #1’s Tuberculosis diagnosis. During an interview conducted on 11/30/23 at 11:50 AM with Staff D, Section Chief Pulmonary Program Director, confirmed the likelihood that the patient had Tuberculosis on the 2/26/23 and based on the findings on the x-ray should have been admitted and treated until three (3) negative sputum samples were obtained for Acid Fast Bacilli. On 11/30/23, the facility began to trace and screen staff that were exposed to the infectious patient; on 12/4/23 identified and screened a roommate and the roommate’s mother that were exposed to the patient. The facility failed to follow its policy and implement measures to minimize the risk of transmission of a communicable airborne disease and implement post exposure screening of staff, visitors, and other patients for a reportable communicable disease in a timely manner. These findings were shared with Staff C, Director of Regulatory Affairs on 12/4/23 at approximately 3:15 PM.”

“IC PROFESSIONAL COMMUNICATION QAPI CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (iii) Communication and collaboration with the hospital’s QAPI program on infection prevention and control issues. This Standard is not met as evidenced by: 17636 Based on document review and interview, it was determined the facility failed to ensure that the infection control program collaborated with the quality assessment improvement program to control the exposure and spread of an infection. Findings include: The document titled “Performance Improvement/Patient Safety Plan 2023-2024” states, “To achieve its goals, Northwell Health shall review and outline infection prevention activities and epidemiology methodologies that reduce the risk of acquisition and transmission of hospital acquired infections. Data concerning infections shall be systematically collected, analyzed, and regularly reviewed by organizational and hospital leadership. The reduction of hospital acquired infections shall be integrated into the Strategic Plan for Clinical Excellence and Quality/Patient Safety and shall provide a framework for reducing the risks of infection.” During an interview conducted on 11/30/23 at 9:55 AM with Staff A, Program Director Infection Prevention Committee, Staff A stated that a nurse from the County Department of Health (DOH) alleged during a phone call on 10/27/23 that a patient (MR #1) was treated and released from Northern Westchester Hospital with a communicable reportable disease (Tuberculosis) without the facility notifying the County Department of Health as required by New York State Public Health law. Staff A stated she sent an email that day (10/27/23) to the Director of the Chief Medical Officer, the Infectious Disease Medical Doctor, Director of the Emergency Department, and the Director of Nursing in the Emergency Department. Staff A confirmed the patient was in the Emergency Department on 2/26/23 and 10/21/23 with symptoms of a Tuberculosis infection. Staff A acknowledged that she had not taken any further action and that a root cause analysis would be done on 12/6/23, more than nine (9) months after the first potential exposure on 2/26/23 and more than six (6) weeks after the last exposure on 10/21/23. Review of the infection control minutes for 2023 revealed there was no documentation of patient MR #1 communicable disease incident. The staff, patient, visitors, and community exposure to MR # 1 Tuberculosis infection was not documented as being addressed at these meetings. Review of the quality assessment performance minutes for 2023 revealed there was no documentation that this incident was analyzed, or any corrective measures were discussed and implemented for the exposures. These findings were shared with Staff C, Director of Regulatory Affairs on 12/4/23 at approximately 3:30 PM.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 17636 Based on medical record review, document review and interview, in one (1) of 24 medical records reviewed, it was determined the facility failed to implement policies to perform an appropriate medical screening examination and provide stabilizing treatment to a patient. Findings include: Review of medical record #1 revealed a 73-year-old patient presented to the Emergency Department on 2/26/23 with complaint of cough and weight loss. Significant findings revealed the chest x-ray showed “mild to moderate perihilar interstitial infiltrates bilaterally. Patchy consolidation/atelectasis/effusion at the right base.” The patient was discharged home with prescriptions for Pneumonia. The patient returned to Emergency Department on 10/21/23 with complaints of hemoptysis and weight loss. A CT-scan showed the patient has extensive consolidative changes and numerous cavitating nodules some of which communicate with the adjacent bronchus. The patient was discharged from the Emergency Department with a prescription for an antibiotic. The facility failed to conduct an appropriate medical screening evaluation to determine whether an emergency medical condition existed before discharging the patient from the emergency department. See findings at A 2406. Review of medical record #1 identified, the patient returned to Emergency Department on 10/21/23, with complaint of hemoptysis. A CT-Scan showed extensive consolidative changes in the right lower lobe with multifocal areas of cavitating nodularity some of which communicates with the adjacent bronchus as well as innumerable nodular densities throughout the lung fields. The patient was given two (2) antibiotics then discharged from the Emergency Department approximately six (6) hours after arrival, with a prescription for an antibiotic. The facility failed to identify and provide appropriate stabilizing treatment for a patient who presented to the emergency department. See findings at A 2407.”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 17636 Based on medical record review, document review and interview, in one (1) of 24 medical records reviewed, it was determined the facility failed to provide an appropriate and complete medical screening examination for a patient. This was evident for medical record (MR) #1. Findings include: The policy titled “Emergency Treatment, Stabilization, Transfer of Patients and EMTALA (Emergency Medical Treatment and Active Labor Act),” reviewed 3/2020 states, “Every person who comes to a Northwell Health Emergency Department for examination or who presents elsewhere on the premises as defined above and states that he/she has an Emergency will be given an appropriate medical screening examination (MSE) to determine whether an emergency medical condition (EMC) exists.” Review of MR #1 identified this 73-year-old patient arrived at the Emergency Department (ED) on 2/26/23 at 2:13 PM with a complaint of cough x 2 months, not eating, no appetite and weight loss. The patient had a previous medical history of Hypertension and Diabetes Mellitus and the patient had seen a doctor who prescribed cough medication, but the cough had not improved. The patient’s triage revealed the height was 5’ 4” and the patient’s weight was 115 lbs. The patient was alert and oriented to person, place and time and his vital signs upon arrival were temperature 99.1F (normal 97F - 99F), pulse 103 (normal 60-100), respiration 18 (normal 12-20), B/P 165/78 (normal 90-120/50-90) and oxygen saturation was 96% (normal 96%-100%) on room air. The physical examination including lab tests were done, and swabs for viral infections were also negative. A chest x-ray read at 3:39 PM showed “mild to moderate perihilar infiltrates and patchy consolidation/atelectasis/effusion at the right base evident. Impression: mild to moderate perihilar interstitial infiltrates bilaterally. Patchy consolidation/atelectasis/effusion at the right base.” The patient was given Ceftin 500mg and Azithromycin 500 mgs (antibiotics) at 5:15 PM, orally, then discharged from the Emergency Department at 5:48 PM with a diagnosis of Acute Cough and Pneumonia; prescriptions for Ceftin 500mg twice per day x 7 days and Azithromycin 250mg daily x 4 days and instructions to follow-up with his primary doctor in one (1) week. There was no complete assessment of the weight loss and x-ray findings of the patchy consolidation at the right base of the lung. The patient returned to the Emergency Department on 10/21/23 at 3:47 PM, with complaint of hemoptysis (coughing up blood) x 2 days. The patient’s weight had decreased to 107 lbs. Diagnostic workup included a CT-Scan. The radiologist documentation at 8:03 PM, indicated the CT-Scan of the chest showed “diffuse bronchiectasis. Extensive consolidative changes in the right lower lobe with multifocal areas of cavitating nodularity some of which communicates with the adjacent bronchus as well as innumerable nodular densities throughout the lung fields, right lung greater than the left, may represent extensive infectious or inflammatory etiology however neoplastic etiology cannot be ruled out.” The Emergency Department’s doctor documented at 8:15 PM that a CT-Scan of the chest showed “the patient has extensive consolidative changes and numerous cavitating nodules some of which communicate with the adjacent bronchus which likely explains hemoptysis.” The doctor also documented a message was sent to the radiologist to ask if the imaging is consistent with pulmonary tuberculosis (TB). The radiologist documented an addendum at 8:20 PM indicating the “Differential diagnosis includes fungal infection and Tuberculosis cannot be excluded.” The Emergency Department doctor documented “Sputum tests to include culture, fungal infection, and AFB (acid fast bacilli to detect TB infection) culture were ordered; however, patient is having difficulty producing sputum for the test. Will allow an additional 20 minutes or so for patient to attempt to produce some sputum, otherwise these tests will need to be performed in the outpatient setting.” The patient was discharged from the Emergency Department at 9:27 PM with a prescription for Doxycycline (antibiotic) and a diagnosis of possible bacterial infection. “The primary diagnosis was hemoptysis with additional impression of pulmonary cavitary lesion, multiple pulmonary nodules, you may have a bacterial infection, fungal infection, Tuberculosis, inflammatory disease or lung cancer.” There was no documentation in the medical record that a complete and appropriate screening was provided for the symptoms presented. During interview of Staff F (Chief Medical Officer) conducted on 11/30/2023 at 10:11 AM, Staff F stated that Staff G, Program Director Infection Prevention Committee escalated this case to me about two weeks ago and the response from the emergency department was not appropriate. All the questions that should have been asked during the visit were not asked. The patient’s chart was empty. Furthermore, the patient was not isolated, not placed on airborne precautions and was then released back into the community when he should have been admitted. During an interview conducted on 11/30/23 at 10:40 AM with Staff A, the first Emergency Department doctor that saw the patient on 10/21/23, Staff A stated, “the patient did potentially have an emergency medical condition.” During an interview with Staff B, Section Chief, Pulmonary Program Director conducted on 11/30/23 at 11:50 AM, Staff B stated given the patient’s presentation with hemoptysis, the patient should have “been admitted, placed on airborne isolation, treated with oral antibiotics, and the staff should have collected AFB x 3 before discharging the patient from the hospital. We should have established how much blood and with the extent of the cavitation. If the patient had cancer the patient should also be admitted because of the bleeding, this is a priority.” These findings were shared with Staff C, Director of Regulatory Affairs on 12/1/23 at approximately 3:15 PM.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 17636 Based on medical record review, document review and interview, in one (1) of 24 medical records reviewed, it was determined the facility failed to (a) complete an appropriate medical screening exam and (b) initiate appropriate treatment determination before the patient was discharged from the Emergency Department. This finding was evident in medical record (MR) #1. Findings include: The policy titled “Emergency Treatment, Stabilization, Transfer of Patients and EMTALA (Emergency Medical Treatment and Active Labor Act),” reviewed 3/2020 states, “... A medical condition is stabilized when the hospital has provided sufficient treatment to assure, within reasonable medical probability that no clinical deterioration of the condition is likely to result from or occur during transfer or with respect to discharge, the treating physician has determined, with reasonable clinical confidence, that the emergency medical condition has resolved, and that continued care can be reasonably performed on an outpatient basis.” Review of Medical Record #1 identified this 73-year-old patient presented to the Emergency Department on 2/21/23 at 2:13 PM with complaints of cough x 2 months, no appetite and weight loss. Significant physical assessment finding was the patient’s weight of 115 lbs. Diagnostic workup showed the radiologist identified on a chest x-ray there was “mild to moderate perihilar infiltrates and patchy consolidation/atelectasis/effusion at the right base. Impression: mild to moderate perihilar interstitial infiltrates bilaterally. Patchy consolidation/atelectasis/effusion at the right base.” The patient was discharged from the Emergency Department at 5:48 PM that day after receiving stat doses of antibiotics and prescriptions for antibiotics to treat Pneumonia. The patient returned to the Emergency Department on 10/21/23 at 3:47 PM with a complaint of hemoptysis (coughing up blood) x 2 days. The patient’s weight had decreased to 107 lbs. The significant finding was the radiologist documentation at 8:03 PM that the CT-Scan of the chest showed “diffuse bronchiectasis. Extensive consolidative changes in the right lower lobe with multifocal areas of cavitating nodularity some of which communicates with the adjacent bronchus as well as innumerable nodular densities throughout the lung fields, right lung greater than the left, may represent extensive infectious or inflammatory etiology however neoplastic etiology cannot be ruled out.” The radiologist documented an addendum at 8:20 PM indicating the “Differential diagnoses includes fungal infection and Tuberculosis cannot be excluded.” The patient was discharged from the Emergency Department at 9:27 PM that night with a prescription for Doxycycline (antibiotic) and a diagnosis of “possible bacterial infection. The primary diagnosis was hemoptysis with additional impression of pulmonary cavitary lesion, multiple pulmonary nodules, you may have a bacterial infection, fungal infection, Tuberculosis, inflammatory disease, or Lung Cancer.” The facility failed to identify the extent of the patient’s medical symptoms and condition and make a determination for appropriate treatment. During an interview with Staff B, Section Chief Pulmonary Program Director conducted on 11/30/23 at 11:50 AM, Staff B stated given the patient’s presentation with hemoptysis, the patient should have “been admitted, placed on airborne isolation, treated with oral antibiotics, and the staff should have collected AFB x 3 before discharging the patient from the hospital. We should have established how much bleeding and with the extent of the cavitation the patient must be admitted.” These findings were shared with Staff C, Director of Regulatory Affairs on 12/1/23 at approximately 3:30 PM.”