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2323 N LAKE DR

MILWAUKEE, WI 53211

PATIENT SAFETY

Tag No.: A0286

Based on record review and interview staff failed to develop and implement a comprehensive corrective action plan and monitor the action plan for compliance in 1 of 1 adverse events reviewed (Patient (Pt) #1); in a total sample of 1 adverse event reviewed.

Findings Include:

Review of policy and procedure titled, "Event Reporting" last revised 03/14/2023 revealed the following:
- "The leader or designee of the department/nursing unit/medical group site whereby an event occurs is responsible for initiating investigation action, follow-up of all events, and tracking/trending of all events which occurred within..."
- "Specific events will be reviewed by the Safety Event Review Team (SERT) or SERT sub-team to determine the need for investigation or Root Cause Analysis (RCA) completion."

Review of policy and procedure titled, "Fire Plan and Fire Risk Assessment--Surgical Services and Procedural Areas" last approved 04/11/2023 revealed the following:
- "All aerosols, tinctures, and other flammable compounds will not be used in the presence of an ignition source."
- "Alcohol based skin prep solutions must be allowed to dry for at least 3 minutes..."

Review of policy and procedure titled, "Electrosurgery" last reviewed 06/12/2022 revealed the following:
- Policy Statement: "To provide guidance to perioperative personnel for the use and care of electrosurgical equipment...The expected outcome is the patient is free from signs and symptoms of electrical injury."

Review of Pt #1's incident report revealed on 02/28/2024 (no time), "Physician Assistant (PA B)...was applying Cavilon Barrier film (protects skin from irritation) for Wound Vac Dressing around the surgical site. Before the Cavilon was able to dry, (Surgeon A) used the Bovie at the surgical site which caused a fire. The entire surgical site caught fire and a small portion of the surgical drape, which lasted approx (approximately) 5 seconds. (PA B) and (Surgeon A) put out the fire with sterile towels which were at the field. (Surgeon A) and (PA B) examined the patient for injury and did not note any new injuries. Both (Surgeon A) and (PA B) finished putting on patient dressing and surgery was finished..."

Per interview with PA B on 05/10/2024 beginning at 1:27 PM, PA B stated that the surgical fire occurred after Pt #1's procedure had ended. PA B stated that Surgeon A completed Pt #1's wound debridement and PA B was prepping the skin to place a Wound Vac over the surgical site. PA B stated that she/he applied the barrier film (flammable when wet) to the surgical site and before it could dry, Surgeon A proceeded to use the Bovie Pen to stop a small bleed and this resulted in a "flash" fire. PA B stated that there is a risk for fire when the Bovie Pen (heat source) comes in contact with a flammable substance. PA B stated that there was no formal education/reinforcement provided and that the team talked about the incident and determined the Bovie would be taken "off the field" when using skin prep; PA B stated, "a verbal discussion was sufficient."

Per interview with Surgeon A on 05/10/2024 beginning at 5:10 PM, Surgeon A stated that PA B was applying skin prep for the placement of a Wound Vac and Surgeon A noticed there was bleeding coming from Pt #1's surgical site. Surgeon A attempted to use the Bovie Pen to stop the bleeding and this "sparked a fire." Surgeon A stated, "I don't know what I was thinking." Per Surgeon A, Surgeon A and PA B put the fire out with wet surgical towels and the patient was unharmed. Surgeon A stated that after the incident an action plan was developed for the Operating Room (OR) nurse to be responsible for unplugging the Bovie Pen when alcohol based skin prep was being applied to prevent an incident like this from occurring again.

Per interview with Director of Surgery C on 05/10/2024 beginning at 2:16 PM, Director C was informed of the incident immediately. Director C stated that she/he met with leadership, Quality, and Safety and determined that staff should unplug the Bovie Pen until the skin prep is dry. Director C stated that this was shared with staff (Registered Nurse (RN), First Assistants, Surgical Technicians) during safety huddles and a staff meeting. When asked if all staff were educated on the new process, Director C stated, "We were able to catch the majority of staff." Per Director C, she/he did not keep track of who attended the huddles. Director C stated that no formal education went out to the Surgeons/Providers; per Director C, the staff meeting and staff huddles captured the First Assistants, RNs, and Surgical Technicians. Director C stated that there is no documentation of staff conducting audits and monitoring to ensure that the OR staff are compliant with the new process.

Per interview with Quality Manager F on 05/10/2024 beginning at 3:13 PM, Manager F stated a Safety Event review team conducted a review of the incident (Nursing leadership, Provider leadership, Safety, Risk Management, and Quality) and the team determined that based on the facts a RCA was not necessary. Per Quality Manager F, the facility is unable to release the meeting minutes showing documented evidence of this incident review and investigation due to being protected information.

Review of the Daily OR Safety Huddles from 03/01/2024, 03/04/2024, 03/08/2024, 03/11/2024, and 03/12/2024 revealed documentation to "turn off" and/or "unplug" the Bovie Pen when applying skin prep using a "lollipop" (Chlorprep stick/swab--alcohol based skin prep); there was no documentation of which staff attended the Safety Huddles. There was no documentation of the education addressing the use of the Cavilon Barrier Film used for Wound Vac skin prep.

Review of the "Associate Meeting" power point slides dated 03/14/2024 revealed, "Reminder: Unplug bovie when using prep (skin prep)-do not plug it in until the dry time has elapsed. This is to prevent surgical fire." Review of the staff meeting attendance sheet revealed 11 RN's and 12 Surgical Technicians/First Assistants did not sign off as being in attendance for this meeting. There was no documentation of the education addressing the use of the Cavilon Barrier Film used for Wound Vac skin prep.

Per email correspondence with Quality Manager H on 05/13/2024 at 3:40 PM, when asked if all Surgeons and Providers who use the Bovie Pen during surgery have been informed of this incident and educated on the new process, Manager H responded that there was no documented evidence that this was shared with all Surgeons and Providers.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on staff interview and record review from 05/10/2024 through 05/14/2024, the Ascension Columbia St Mary's Hospital failed to construct, install, and maintain the building systems to ensure safety of patients.

Findings include:

The facility was found to contain the following deficiencies.
K711 - Evacuation and Relocation Plan
S948 - Other Physical Environment - Fire Report-1.-124.36

As a result of these deficiencies, 42 CFR Subpart CFR 482.41 Condition of Participation: Physical environment was NOT MET

See K-tags for details of the specific findings.

LIFE SAFETY FROM FIRE

Tag No.: A0709

Based on staff interview and record review from 05/10/2024 through 05/14/2024, the Ascension Columbia St Mary's Hospital failed to construct, install, and maintain the building systems to ensure safety of patients.

Findings include:

The facility was found to contain the following deficiencies.

K711 - Evacuation and Relocation Plan
S948 - Other Physical Environment - Fire Report-1.-124.36

As a result of these deficiencies, 42 CFR 482.41(b) Standard: Safety from Fire was NOT MET

See K-tags for details of the specific findings.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, record review, and interview surgery staff failed to ensure skin antiseptic (non-alcohol) was applied as per manufacturer's guidelines to ensure effective skin antisepsis prior to a surgical procedure in 1 of 1 surgery observation (Pt #2), in a total sample of 1 observation of surgery.

Findings Include:

Review of the manufacturer's guidelines for Bactoshield CHG (Chlorhexidine Gluconate) 4% (non-alcohol skin prep) revealed, "Patient Preoperative skin preparation: Apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel...Repeat procedure for an additional 2 minutes and dry with a sterile towel."

On 05/10/2024 beginning at 2:00 PM, while observing Pt #2's surgical procedure in the operating room (OR), observed Circulating Registered Nurse (RN) E applying skin antiseptic (CHG) to Pt #2's back prior to Pt #2's surgery. RN E applied the skin prep for 2 minutes then draped the patient; RN E did not dry the skin with a sterile towel and repeat the steps to ensure proper skin antisepsis as per the manufacturer's guidelines for use.

During interview with Surgery Director C on 05/14/2024 beginning at 12:30 PM, Director C observed Pt #2's surgery on 05/10/2024 and confirmed that RN E did not apply the skin antiseptic as per manufacturer's guidelines. Director C stated that OR staff should following the manufacturer's guidelines for use when applying skin antiseptic and ensure skin prep is dry before draping.