Lakewood Ranch Medical Center

“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: 53733 Based on facility policy, medical record reviews, facility documents, and interviews, the facility failed to investigate, measure, analyze and track events in 3 of 3 events reviewed. Findings included: Review of the facility policy titled “Risk Management/Patient Safety Plan” last reviewed 5/21/25 ...III Roles and Responsibilities A. Responsibilities for Patient Safety and Risk Management...The Risk Director is responsible for implementation and oversight of LRMC’s internal risk management program....and will act as the Patient Safety Officer... G. Root Cause Analysis...RCA responsibilities (Risk/Quality) ...Conduct and be actively involved in the investigation, RCA[root cause analysis], and corrective action plan implementation process... Communicate the progress of the investigation, institutional barriers and finalized action plan to executive leadership. Monitor goals and progress towards completion of the correction Action Plans. 1. Review of the medical record for Patient #16 revealed that patient was admitted on 01/21/2025 for right ankle surgery. A right ankle surgical consent was completed, and the right ankle was marked. A review of the Adductor Canal Block of the Saphenous Nerve form on 1/21/2025 at 1:22 PM showed a block for the Left Ankle. “Right” was circled and then scratched out. Review of the Anesthesiology pain service consultation and procedure note dated 1/21/2025, showed left ankle procedure completed under general anesthesia. Review of the Facility’s investigation dated 2/12/2025 revealed that there was a breakdown between staff and providers”, the block was done in a different space (pre-op vs. OR [operating room]). There was a distraction during the case that created the breakdown. During an interview on 4/20/2026 at 2:55 PM, the Director of Surgical Services said the event was discussed. Audits have been performed with observations of every nerve block for every surgical patient. During an interview on 4/21/2026 at 10:00AM, the Director of Quality and Accreditation said Patient #16 was scheduled for a right ankle arthroscopy and then it was decided the patient would have a nerve block for pain control. The block was done in the operating room. The CRNA (Certified Registered Nurse Anesthetist) together with an orientee CRNA, were responsible for the nerve blocks on the thigh area. The surgeon and anesthesia marked the ankle prior to patient going to OR (operating room). The nerve block was completed. Soon after, the scrub tech noticed the block was on the wrong leg. After the Anesthesiologist was notified, the correct side was completed. During an interview on 4/21/26 at 2:08 PM, the Director of Surgical Services said the Pre-op Charge does the audits in pre-op. She was keeping them. She was checking them off on the schedules. She threw them away. We aren’t writing anything down. During an interview on 4/22/2026 at 12:11PM, the Director of Surgical Services disclosed that daily audits were completed for both events (January 2025 and January 2026.) For the January 2025 audits that were completed, they were completed in the operating room as this is where the issue occurred with the anesthesia time out. The audits started right after the January 2025 incident and continued until October 2025. We have those in OR Managers office in a box. The last month of the audit, the audits began tapering off as it became repetitious and held no value. After the January 2026 event, daily audits were completed in the pre-operative area for patients who had nerve block done. If the block was done in OR, the time out for the nerve block was not observed by the leaders. During an interview on 4/22/2026 at 2:34PM, the Director of Surgical Services explained that the action plan was geared toward making sure the time outs were done. It was geared towards a “yes” or “no” answer. We didn’t document each piece of the time out process. Only that it was completed. Any issues were addressed in real time. During the RCA we didn’t put together an audit tool or form. We just made sure that the audits were done. We had quite a few as we do every block. The Director of Surgical Services states there isn’t a form. He also explained that he personally does10 audits a month and presents the information from his audits to the Patient Safety Council. He stated, “you know how it is; you report only what you do?” During an interview on 4/23/2026 at 11:00AM, the Director of Risk Management (DRM) stated the audits are done by OR staff and are supposed to be reported at the Patient Safety Council meeting. She then said, “there isn’t anything turned into me.” The DRM revealed that the Surgical Services Director reports 100% of the audits for the time out process. During an interview on 4/23/2026 at 12:00PM, the Director of Surgical Services explained that during 2025 all of the audits that were completed, were saved in a box. When we had the 2026 event, we kept the audits for 3 weeks but decided to toss them out as they were just a bunch of papers. Review of the audits during the timeframe January 2025 through October 2025 reflect daily surgical schedules with patients’ names highlighted and checkmarks that identify who had nerve blocks and who was observed during the time out process. These are kept in a box in the OR managers office. 2. Review of Patient #6’s medical record revealed admitted on 01/16/2026 for right shoulder surgery and a time out was completed for right shoulder at 7:21AM. At 1:00 PM, the nursing note revealed the left upper extremity Strength-2-unable to move against resistance. At 11:59PM, the anesthesia note revealed the patients name, date of birth and surgical site marking were reviewed and compared to consent form to ensure accuracy. The patient was placed in a semi-upright position with head turned to opposite side of block. The left supraclavicular fossa and neck were prepped. During a discussion of the Facility’s investigation with the Director of Quality revealed the investigation was conducted on 1-27-2026 and it revealed the time out was done correctly but a disruption occurred as another physician needed to emergently use the ultrasound machine. They removed it from the room where the Patient #6 was located. It was returned shortly after being used but was brought back to the room and placed on the opposite side of the patient where it originated from. The time out was done prior to the surgery, but when the surgical process was disrupted, another time out was not completed. She disclosed the team followed the policy and protocol of time out, but a loophole was identified. The surgical services leadership and operating room team came up with a process to prevent reoccurrence by performing a time out immediately prior to any nerve block being performed. A process of auditing every nerve block would be completed to validate the process changes made and education were being followed. During an interview with the Director of Surgical Services, on 4/21/26 at 2:08 PM, he said there was a verbal corrective action sheet for the nurse involved. Education was the big piece of the corrective action. The education was reinforcement of what they already know. The Pre-op Charge does the audits in pre-op. He puts his audits in the Patient Safety portal. They talk about the audits. I report everything to Patient Safety. The Pre-Op Charge has the schedules. She highlights the [nerve] blocks so we can see them. We are doing 100%. She was keeping them. She was checking them off on the schedules. She threw them away. We aren’t writing anything down. During an interview on 4/23/2026 at 12:00 PM, the Director of Surgical Services explained when we had the 2026 event, we kept the audits for 3 weeks but decided to toss them out as they were just a bunch of papers. Review of the audits for January 2026 through April 2026 revealed there are only 3 weeks of audits during this timeframe, these represent daily surgical schedules with highlighted patients and checkmarks that identify who had nerve blocks and who was observed during the time out process. The Director of Surgical Services printed the daily surgical schedule from 1/27/2026 through current day (4/23/2026) and highlighted patients who had a block. During an interview on 4/20/2026 at 2:55PM, the Director of Surgical Services said he remembers the event clearly and the entire team has been diligent to prevent this from occurring again. Audits have been performed with observations of every nerve block for every surgical patient as well as huddles have been done daily discussing the process. He also referred further information regarding huddles and education to the manager. During a discussion on 4/21/26 at 1:26 PM the Peri-Operative Manager said the charge (charge nurse) in pre-op and myself, are watching the pre-op blocks. “We aren’t using an audit form. We have been doing them since January.” During an interview on 4/21/26 at 1:30 PM, the Pre-op Charge RN (Registered Nurse) said she watches 99% of the nerve block observations. She gets the schedule every morning and highlights all the blocks. They just started them in January. She checks them off. She disposes of them when she is done. There have been no concerns. We provided education and it has improved. We do the audits and re-educate the staff on what a time out is, what a nerve block is, what a procedure time out is. We have always had that in place. There is no change to the process. Just making sure they are following it to a “T”. During an interview on 4/21/26 at 1:41 PM, Staff J, Anesthesiologist said he is not comfortable talking about it. There was a break from when they did the first time out. It was reported to the risk manager and management team, and steps were taken to make sure it doesn’t happen again. If there is a break in the time out, it has to be done again. 3. Review of the medical record for patient #17 revealed on 2/7/2025 patient was admitted for active labor progressing to a completed natural delivery. On 2/7/2025 at 4:15PM, the OB Admission-Operative Report completed by the nurse midwife stated all gauze sponge, laps, instruments and needles were accounted for. 2/9/2025 at 7:32PM, the Nursing Progress note stated Patient #17 called nurse to room. She had passed gauze sponge in the toilet. Review of the post-partum/OB/GYN documentation 2/7/2025 15:36 PM through 2/9/2025 09:58PM revealed there is no documentation of vaginal packing and no reason noted for gauze sponge in the vagina. During an interview on 04/22/2026 at 1:22 PM, the Midwife stated the scrub tech is responsible for the count but as a team we all share the responsibility. Everyone was a part of the gauze count; the pre-count and post count matched. She said the entire team in the delivery room were baffled because the counts matched. They were counted a few times. She explained the new process is gauze is no longer in the delivery packs but remain on the delivery cart. ,”