St Josephs Community Hospital West Bend

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 50644 Based on record review and interview the facility failed to complete actions on their Safe Organization Analysis and Redesign (SOAR) Process by the due dates set in place for 1 out of 1 SOAR plans reviewed. Findings Include: Failed to complete actions on facility SOAR Process. See Tag A-0286.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 50644 Based on record review, observation and interview, the facility staff failed to ensure alcohol-based prepping solution (Chloraprep) was not pooled on drapes or linens, removing alcohol soaked linens prior to draping and allowed to dry per the manufacturer’s instructions for use for 2 of 12 patients (Patient #2 and #3) prepped prior to a sterile procedure; failed to address fire risk and preventions in a pre-surgical time out per policy and standards of practice for 2 of 12 (Patient #1 and #3) patients; and failed to prevent oxygen from getting trapped under surgical drapes when an open source of oxygen is being used in the presence of electrocautery for 2 of 12 (Patient #1 and #2) patients, resulting in a surgical fire with burns to Patient #1 in a total universe of 12 surgical patients. Findings Include: The facility failed to minimize surgical fire risk. See tag A-0951.”

“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: 50644 Based on record review and interview the facility failed to complete actions on their Safe Organization Analysis and Redesign (SOAR) Process by the due dates set in place for 1 out of 1 SOAR plans reviewed. Findings Include: A review of facility “Safe Organization Analysis and Redesign (SOAR) Process” (no date) revealed, “...Executive Sponsor to ensure timely completion of action plan by navigating barriers and facilitating connections...” A review of facility policy #5596 titled, “Patient Safety Event Reporting and Investigation Policy” last reviewed 9/6/2024 revealed, “...The SOAR action plan will be reviewed and approved by the Enterprise Safety Opportunity Response Team (SORT) Committee. The Committee will also provide oversight for the implementation and monitoring of the action plan...” Patient #1 suffered 2% thickness burns to face and neck on 02/12/2026 as the result of an intraoperative surgical fire. Patient safety, physicians and leaders met 2/12/2026 to discuss the events of the fire and conducted interviews. It was determined that a SOAR event needed to be initiated due to the patient safety risk assessment. On 02/13/2026 patient safety had a report off huddle and disclosed to the family and initiated the SOAR. A review of the facility’s SOAR in response to Patient #1’s event revealed the first meeting to discuss the contributing factors and action items occurred on 3/11/2026. Further review of the SOAR document revealed 8 identified action items were documented as to be completed on 3/29/2026 or completed. There was insufficient evidence found to verify completion of 6 of the 8 action items including, “Revise surgical time out workflow to include mandatory verbal fire risk assessment ...Update OR timeout poster/checklist to include fire risk assessment prompts ...Education to be completed with OR staff (RNs, surgical techs, anesthesia techs, anesthesia, surgeons) around use of poster ...Reinforcement of standardized draping guidelines for procedures with oxygen near the surgical field with surgeons and anesthesiology: to reduce the oxygen a yankauer will be placed with anesthesia ...implementing monthly surgical timeout audits to evaluate fire risk discussion and mitigation strategies ...update FMFH, FWB Fire Safety Plan and Facility Services Policies ...” During an interview on 3/31/2026 at 9:18 AM, OR RN T stated that no recent re-education has been done regarding fire safety. She stated they did a mock OR fire drill “a bit ago” but no additional education since then. During an interview on 3/31/2026 at 11:15 AM, CRNA W stated that the OR fire was brought up to their anesthesia team, but no formal education has been received since the event. During an interview on 3/31/2026 at 12:00 PM, ST V stated that there has been no recent education regarding fire risk after this event. During an interview on 3/31/2026 at 1:20 PM, OR Manager D and Surgery Director E stated that the fire event was brought up during OR huddles, but no official education has been completed regarding the action items in the SOAR including policy updates and re-education of fire safety or the timeout posters. They stated that there are still changes taking place with the annual drills and revisions to policies and posters that are still not live yet. During an interview on 3/31/2026 at 3:01 PM, Patient Safety Specialist FF stated that she has been facilitating the SOAR process. She stated that there have been policies being updated but are still in the review process and not implemented yet. She stated that there is an OR time out poster completed but hasn’t been rolled out yet because they are waiting on print shop and there will be education conducted on poster once that is complete. She stated there are upcoming staff meetings to educate on some of these updates including new policies once through review.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 50644 Based on record review, observation and interview, the facility staff failed to ensure alcohol-based prepping solution (Chloraprep) was not pooled on drapes or linens, removing alcohol soaked linens prior to draping and allowed to dry per the manufacturer’s instructions for use for 2 of 12 patients (Patient #2 and #3) prepped prior to a sterile procedure; failed to address fire risk and preventions in a pre-surgical time out per policy and standards of practice for 2 of 12 (Patient #1 and #3) patients; and failed to prevent oxygen from getting trapped under surgical drapes when an open source of oxygen is being used in the presence of electrocautery for 2 of 12 (Patient #1 and #2) patients, resulting in a surgical fire with burns to Patient #1 in a total universe of 12 surgical patients. Findings Include: Examples of surgical prep: A review of facility policy #2556 titled, “OR [Operating Room] Fire Safety Policy” last revised 6/4/2025 revealed, “Prevention:...Ensure alcohol-based skin prep solution does not soak into the patient’s hair or linens by placing sterile towels to absorb drips and runs during application...Ensure that alcohol-based skin prep solution is completely dry prior to draping, following manufacturer’s recommendations for dry times...” A review of “AORN [Association of Perioperative Registered Nurses] Guidelines for Perioperative Practice” 2026 Edition revealed, “...Prevent contact between fuel sources and ignition sources...When applying flammable skin antiseptic agents, prevent the solution from pooling under, on, or near the patient by...removing materials that become wet with the skin antiseptic agent before draping the patient and moving flammable antiseptic solution soaked materials away from ignition sources...Follow the skin antiseptic manufacturer’s IFU for the recommended minimum dry time and allow the agent to dry completely before applying sterile surgical drapes...” A review of “ChloraPrep 26 mL [milliliter] applicator” IFU’s [Information for Use] (no date) revealed, “Patient preoperative skin preparation...70% isopropyl alcohol...Do not drape or use an ignition source(e.g., cautery, laser) until the solution is completely dry for a minimum of three minutes on hairless skin and up to one hour in hair. Do not allow the solution to pool. Remove wet materials from the prep area...” During an observation of Patient #2 on 3/31/2026 starting at 9:52 AM, observed Patient #2 being brought to OR 2 for an open reduction internal fixation of 2nd toe with Surgeon DD. A stockinet and tourniquet were placed on Patient #2’s right mid-calf and Chloraprep (alcohol based skin prep) was used to prep Patient #2’s foot, ankle, and lower leg circumferentially. There was evidence that skin prep agent was present on the stockinet upon completion of the prep and was not removed prior to draping. No additional dry time was allowed for drying of a drape/linen as per IFU and no evidence that the stockinet was removed from Patient #2’s leg. Cautery was present and set at 35/35. During an observation of Patient #3 on 3/31/2026 starting at 10:19 AM observed Patient #3 being brought to OR 4 for a robotic inguinal hernia repair. Patient #3’s hair was clipped to right below the nipples and Patient #3 was prepped with Chloraprep from nipples to pubis, sheet to sheet. During prepping, the Circulating RN (Registered Nurse) prepped Patient #3’s hair that was not clipped above the nipple line and into the hairy groin area, completely covering it with prep. There was also prep that went on and underneath the warming device. Three minutes was waited for dry time, with no evidence of a longer dry time to allow for the prep in the hair to dry and no evidence of the saturated warming device being removed from Patient #3 prior to draping. The patient was then draped. During an interview on 3/31/2026 at 9:18 AM, OR RN T stated that for flammable prep solution, dry time and IFUs should be followed to decrease fire risk. She stated that there should be no pooling of prep solution and no prep solution left behind before draping. During an interview on 3/31/2026 at 9:41 AM, Surgery Director E stated that they follow AORN guidelines and that anesthesia is a contracted service and per their contract is to follow the facility policies and procedures. During an interview on 3/31/2026 at 11:27 AM, OR RN S stated that for Chloraprep, the dry time is 3 minutes and they should avoid getting prep in the hair or linens and if it does get on linens it should be removed from the patient. During an interview on 3/31/2026 at 11:49 AM, Surgical Assist (SA) R stated they need to follow dry times and IFUs for surgical preps and make sure there is no pooling or wet soaked drapes or linens. When asked about the dry time for hair SA R stated, “It might be a little longer per the IFU.” During an interview on 3/31/2026 at 12:00 PM, ST (Surgical Technologist) V stated that dry time wouldn’t change if Chloraprep was in a patient’s hair and that the bear huggers and blankets are just left on the patients if they have prep on them. Examples of failing to tent drapes: A review of facility policy #2556 titled, “OR Fire Safety Policy” last revised 6/4/2025 revealed, “Prevention: Involves awareness of the Fire Triangle...Prevention Practices: Avoid use of blow by oxygen. Prevent oxygen from getting trapped under surgical drapes by configuring drapes to allow for sufficient venting...” A review of “AORN Guidelines for Perioperative Practice” 2026 Edition revealed, “...configure surgical drapes placed near the patient’s head in a manner that allows the oxygen to flow freely and prevents accumulation under the drapes...” A review of Patient #1’s medical record revealed that a foreign body removal on the face and neck was attempted on 2/12/2026 by Surgeon X under MAC (monitored anesthesia care) anesthesia by CRNA (Certified Registered Nurse Anesthetist) Y and MDA (Medical Doctor of Anesthesia) Z. Patient #1 was brought to OR 3 at 1:48 PM. Patient #1 was positioned in supine position with the draping to expose the right side of the face and neck. Patient #1 was draped with the drape laying across Patient #1’s face. A review of Patient #1’s “Anesthesia Record” from 2/12/2026 starting at 1:48 PM written by CRNA Y and MDA Z revealed, “...2:11 PM Drape spark followed by complete ignition of simple mask, drapes over face, and pillow...” During an observation of Patient #2 on 3/31/2026 starting at 9:52 AM, observed Patient #2 being brought to OR 2 for an open reduction internal fixation of 2nd toe with Surgeon DD. Observed oxygen mask placed on Patient #2 with oxygen set at 10 Liters by CRNA BB. A drape was placed over the patient, up to mid oxygen mask of Patient #2’s head. The drapes were not tented to allow for removal of oxygen from the 10 L of oxygen flowing from the mask. During an interview on 3/31/2026 at 9:18 AM, OR RN T stated that draping should ensure that oxygen is not trapped underneath the drapes. During an interview on 3/31/2026 at 11:15 AM, CRNA W stated that he doesn’t do a “ton of head and neck cases” but would make sure to tent the drapes to allow oxygen to be released. During an interview on 3/31/2026 at 11:27 AM, OR RN S stated that anesthesia “typically tents the drapes to the IV (intravenous) poles but if there’s more people at the bedside then they don’t tent them.” Examples of failing to complete time-out fire risk assessment/prevention: A review of facility policy #5554 titled, “Time Out, Universal Protocol Policy” last reviewed 6/26/2024 revealed, “...Time Out elements include:...Patient Fire Risk Score (low vs. high), including the presence of ignition source(s), fuel(s), potential for an oxygen-enriched environment; and interventions implemented, as appropriate...” A review of “AORN Guidelines for Perioperative Practice” 2026 Edition revealed, “...As part of the preprocedural briefing process, the perioperative team should initiate a fire risk assessment to assess for the presence of the three elements of the fire triangle...The perioperative team should collaborate to implement interventions that address the fire risks identified during the assessment...Prevent contact between fuel sources and ignition sources...” A review of Patient #1’s medical record from 2/12/2026 of a foriegn body removal procedure revealed that a pre-incision timeout was performed at 1:58 PM along with a fire safety time out. There was no evidence of a fire risk level identified in the fire risk timeout and what preventions/interventions were done relating to the fire risk. There was no evidence that sterile water or saline were on the sterile field. During an observation of Patient #3 on 3/31/2026 starting at 10:19 AM observed Patient #3 being brought to OR 4 for a robotic inguinal hernia repair. A time out was completed at 10:51 AM and fire risk was not included as part of the time out including what preventions were available in the room to prevent a fire. An additional staff member then stepped in and asked about fire risk and the Circulating RN stated fire risk “low” which based on AORN standards would have been higher than a low risk because of the use of cautery, alcohol based skin prep and gases being used in the abdomen. During an interview on 3/31/2026 at 9:18 AM, OR RN T stated that they should have water on the sterile field and that oxygen should be decreased when using cautery to prevent surgical fires. OR RN T stated that saline and wet sponges should be on the sterile field and the fire risk and preventions should be discussed during the pre-incision time out. During an interview on 3/31/2026 at 11:27 AM, OR RN S stated that a fire safety time out is to be done before every procedure and that the fire risk gets charted in the patient record. She stated that there has to be water/saline in the room. During an interview on 3/31/2026 at 11:49 AM, SA R stated that to prevent surgical fires they should have water or saline on the sterile field,”

“LIFE SAFETY FROM FIRE CFR(s): 482.41(b) Life Safety from Fire This Standard is not met as evidenced by: 12316 Based on staff interview and record review on 02/20/2026, Froedtert West Bend Hospital, West Bend, failed to construct, install, and maintain the building systems to ensure safety of patients. Findings include The facility was found to contain the following deficiency. K711 - Evacuation and Relocation Plan As a result of the above deficiency, 42 CFR 482.41(b) Standard: Life Safety from Fire was NOT MET. See K-tag for details of the specific findings.”