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Based on observation, interview, review of incident and medical record documentation for 1 of 1 surgical patient (Patient 1), review of manufacturer's instructions for surgical equipment and supplies, review of policies and procedures, review of surgical safety tools, review of fire safety and response documentation, review of equipment PM documentation, and review of product websites and other documentation it was determined that the hospital failed to ensure the provision of safe and appropriate care to patients in the hospital in a manner that complied with all Conditions of Participation.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A-0115 under CFR 482.13 - CoP: Patient's Rights.

2. Refer to the findings cited at Tag A-0263 under CFR 482.21 - CoP: Quality Assessment and Performance Improvement.

3. Refer to the findings cited at Tags A-0709 and A-0724 under CFR 482.41- CoP: Physical Environment.

4. Refer to the findings cited at Tags A-0940 and A-0951 under CFR 482.51- CoP: Surgical Services.

Based on observation, interview, review of incident and medical record documentation for 1 of 1 surgical patient (Patient 1), review of manufacturer's instructions for surgical equipment and supplies, review of policies and procedures, review of surgical safety tools, review of fire safety and response documentation, review of equipment PM documentation, and review of product websites and other documentation it was determined that the hospital failed to ensure each patient's right to receive care in a safe setting.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A-0144 under CFR 482.13(c) - Standard: Privacy and Safety.

2. Refer to the findings cited at Tags A-0709 and A-0724 under CFR 482.41- CoP: Physical Environment.

3. Refer to the findings cited at Tags A-0940 and A-0951 under CFR 482.51- CoP: Surgical Services.

Based on observation, interview, review of incident and medical record documentation for 1 of 1 surgical patient (Patient 1), review of manufacturer's instructions for surgical equipment and supplies, review of policies and procedures, review of surgical safety tools, review of fire safety and response documentation, review of equipment PM documentation, and review of product websites and other documentation it was determined that the hospital failed to fully develop and implement P&Ps that ensured each patient's right to receive care in a safe setting.

Findings include:

1. Refer to the findings cited at Tags A-0709 and A-0724 under CFR 482.41- CoP: Physical Environment.

2. Refer to the findings cited at Tags A-0940 and A-0951 under CFR 482.51- CoP: Surgical Services.

Based on observation, interview, review of incident and medical record documentation for 1 of 1 surgical patient (Patient 1), review of manufacturer's instructions for surgical equipment and supplies, review of policies and procedures, review of surgical safety tools, review of fire safety and response documentation, review of equipment PM documentation, and review of product websites and other documentation it was determined that the hospital failed to ensure that the QAPI program was effective to ensure the provision of safe and appropriate care to patients in the hospital.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tags A-0709 and A-0724 under CFR 482.41- CoP: Physical Environment.

2. Refer to the findings cited at Tags A-0940 and A-0951 under CFR 482.51- CoP: Surgical Services.

Based on interview and record review it was determined that the hospital failed to comply with the Life Safety From Fire requirements as indicated on the attached Fire Life Safety CMS 2567 SOD report.

Findings include:

1. Refer to the findings under Tag K-0711 on the Fire Life Safety CMS 2567 SOD report.

Based on interview, review of PM documentation for 4 of 6 Covidien electric cautery machines (ESUs) used in surgical services, and review of the hospital's equipment PM plan and policies and procedures and documents, it was determined that the hospital failed to ensure that all ESUs had undergone PM inspections in accordance with manufacturer's instructions or the hospital's AEM plan.

Findings include:

1. Refer to Findings 11.a. through 11.g. under Tag E-0951 in this report that reflects that surgical services "procedure cards" for all "Tracheostomy" procedures performed throughout the hospital specified required equipment included "ValleyLab Force FX" ESUs.

2.a. The policy and procedure titled "Preventive Maintenance Management Program" dated "effective" 10/28/2020 was reviewed. The document described processes for identification of equipment risk factors and risk levels, and assignment of the frequency of equipment PM inspections.

2.b. An untitled document that described PM and risk analysis data for the "ValleyLab Force FX" ESUs was reviewed. It reflected the justification for the current PM frequency of every two years assigned to that ESU model.

2.c. A "Standard Operating Procedure" document titled "Addition to Alternative Equipment Maintenance Program" dated as "last reviewed ... February, 2018" was reviewed. It reflected that the hospital's Covidien ValleyLab Force FX and FX-C ESU models were approved for an AEM program on 02/07/2018 with a change from the "Manufacturer Listed PM Frequency" of "Semiannual" (every six months) to a "PM Frequency" of "Biennial" (every two years).

3.a. PM records for a sample of Covidien ValleyLab model ESUs were reviewed:

3.b. The PM records for ValleyLab Force FX8 ESU #10-614949 reflected that the ESU was scheduled for "Annual" PM inspections. The record reflected the ESU was put into service on 03/07/2019 and that no PM inspections had been conducted since that time.

3.c. The PM records for ValleyLab FT 10 ESU #10-617589 was reviewed. During the review staff present confirmed this ESU was scheduled for "Annual" PM inspections. The record reflected the ESU was put into service on 05/02/2019, repairs were done in 12/2019 and cables were replaced in 01/2022. However, there was no documentation of annual PM inspections since the ESU had been put into service in 2019.

3.d. The PM records for ValleyLab FT 10 ESU #10-617590 reflected that the ESU was scheduled for "Annual" PM inspections. The record reflected the ESU was put into service on 05/02/2019 and that no PM inspections had been conducted since that time.

3.e. The PM records for ValleyLab FT 10 ESU #10-617591 reflected that the ESU was scheduled for "Annual" PM inspections. The record reflected the ESU was put into service on 05/02/2019 and repairs were done in 03/2021. However, there was no documentation of annual PM inspections since the ESU had been put into service in 2019.

4. The PM findings were confirmed during interview at the time of the review on 01/20/2023 beginning at 1015 with OHSU leadership and management staff from CTS, EHS, Facilities, and Regulatory Affairs. CTS staff stated that the lack of the annual PM inspections was result of a "database malfunction ... glitch."

Based on observation, interview, review of incident and medical record documentation for 1 of 1 surgical patient (Patient 1), review of manufacturer's instructions for surgical equipment and supplies, review of policies and procedures, review of surgical safety tools, review of fire safety and response documentation, review of equipment PM documentation, and review of product websites and other documentation it was determined that the hospital failed to ensure the provision of safe surgical services.

An urgent surgical procedure that involved the neck was performed while a patient was "awake." The patient sustained burns to the neck and head when sparks from the electric cautery device ignited a fire on the surgical drape that covered their face. The patient's neck and head areas had been prepped with a ChloraPrep 26 mL surgical skin prep applicator that contained "70% isopropyl alcohol" and that was prohibited by the manufacturer for use on the neck and head. The procedure, during which a spark producing cautery device was used, was performed while high-flow oxygen was being administered to the patient by a nasal cannula (NC).

Those conditions resulted in actual harm for Patient 1, and potential harm to other patients. It was determined that an IJ situation existed as at the time of this survey, because although the hospital had conducted an investigation and made "pending" plans, it had not taken immediate action to mitigate the immediacy of the situation to prevent recurrence for other patients while long-term, comprehensive corrective actions were being planned and implemented. Refer to Tag A-0000 at the beginning of this CMS 2567 report for details of the IJ identification, notification, removal plan approval, and verification of removal.

This Condition-level deficiency represents a limited capacity on the part of the hospital to provide safe and adequate care.

Findings include:

1. Refer to the findings cited at Tag A-0951 under CFR 482.51- CoP: Surgical Services.

2. Refer also to the findings cited at Tags A-0709 and A-0724 under CFR 482.41- CoP: Physical Environment.

Based on observation, interview, review of incident and medical record documentation for 1 of 1 surgical patient (Patient 1), review of manufacturer's instructions for surgical equipment and supplies, review of policies and procedures, review of surgical safety tools, review of fire safety and response documentation, review of equipment PM documentation, and review of product websites and other documentation it was determined that the hospital failed to ensure the provision of safe surgical services.

An urgent surgical procedure that involved the neck was performed while a patient was "awake." The patient sustained burns to the neck and head when sparks from the electric cautery machine (ESU) ignited a fire on the surgical drape that covered their face. The patient's neck and head areas had been prepped with a ChloraPrep 26 mL surgical skin prep applicator that contained "70% isopropyl alcohol" and that was prohibited by the manufacturer for use on the neck and head. The procedure, during which a spark producing cautery device was used, was performed while high-flow oxygen was being administered to the patient by way of a nasal cannula (NC).

Those conditions resulted in actual harm for Patient 1, and potential harm to other patients. It was determined that an IJ situation existed as at the time of this survey, because although the hospital had conducted an investigation and made "pending" plans, it had not taken immediate action to mitigate the immediacy of the situation to prevent recurrence for other patients while long-term, comprehensive corrective actions were being planned and implemented. Refer to Tag A-0000 at the beginning of this CMS 2567 report for details of the IJ identification, notification, removal plan approval, and verification of removal.

In addition, survey findings reflected that the surgical safety checklist policy and procedure and the surgical safety checklist tool had not been fully developed and were not aligned to ensure that all risks associated with surgical procedures were identified and mitigated by the surgical team. Further, EHR documentation did not clearly reflect that all aspects and elements of surgical safety specified in the hospital's policies and procedures, and process and checklist tools, were followed.

Findings include:

1. The entrance conference was conducted on 01/18/2023 beginning at ~1040 with approximately 17 OHSU staff that included the COO, CNE, CMO, and leadership and management staff from Surgical Services, Anesthesia, Patient Safety, Regulatory Affairs, Quality Management, EHS, and Facilities. During interview at that time the staff confirmed that a fire incident has occurred in an OR on 12/12/2022 and Patient 1 sustained burns on the head and neck as a result. They stated that on 12/13/2022 a comprehensive investigation and analysis of the incident was scheduled and occurred on 12/19/2022. They indicated that a number of opportunities for improvement were identified and were in various stages of planning and implementation as of the date of this survey.

2.a. Comprehensive documentation dated 12/12/2022 and 12/19/2022 for the incident that involved Patient 1 was reviewed. It included, but was not limited to, the following information:
* Patient 1 was seen in the ED on 12/12/2022 for acute respiratory distress, ENT specialty service was consulted and plans were made for an urgent awake tracheostomy in the OR to provide an airway.
* Prior to the procedure in the OR the patient's neck, earlobes and upper chest area were prepped with a "large" ChloraPrep applicator and a timer was set for 3 minutes to allow the site to dry.
* There were issues with the oxygen tubing crimping and getting in the way and concerns that the pt may be tiring out so pt was changed to high flow NC at 30L/min, 100% Oxygen.
* A timeout was held which included a discussion of the fire risk components of the procedure.
* A blue towel was draped over the patient's face.
* Upon beginning to use the cautery device, the surgeon noted more than normal sparking and requested the setting be lowered, sparking continued and the setting was lowered a second time.
* On third attempt to use the cautery device a spark ignited the blue surgical towel/drape and the NC tubing and a fire spread across the patient's face and hair.
* The towel/drape and NC cannula were removed from the pt's face, saline was poured on the fire, the oxygen was shut off and the cautery ESU was unplugged and moved away from the site.
* An overhead code red was not called and the fire alarm was not pulled.
* The team called in the trauma team to assist with assessment of the burns, a flexible bronchoscopy was used to inspect airway and no signs of injury were found.
* "Superficial" burns were assessed on the patient's cheeks, lips, and right-side neck; hair was singed on head, face, eyebrows, and eyelashes; and there were superficial thermal burns to both anterior nasal cavities.
* The patient was sedated and the tracheostomy resumed.
* Patient was transferred to the PACU.

The documentation included, but was not limited to, the following problem identification:
* Awake tracheostomy procedures are among the highest risk procedures for fires in an OR.
* Patient 1 was receiving 30L, 100% high flow nasal cannula. The anesthesia high flow devices do not have a blender on them allowing delivery of lower percentages of oxygen.
* The "larger" ChloraPrep applicator was used. It comes with a "recommendation" that is should not be used on the "head/face." The larger volume may increase the time for drying and increases the risk of pooling around the site potentially leaving a larger amount of alcohol on the field.
* The drape over the pt's face likely caused tenting of the oxygen around the surgical site.
* The oxygen source was not shut off 3-5 minutes prior to the use of the cautery.
* There was no announcement to the room that the cautery device was starting to be used.
* There was no team communication, except between the surgeons, that there were concerns about the cautery sparking, nor did the surgical team inquire about why surgeons requested the cautery be turned down. That would have provided opportunity to reevaluate the fire risk and discuss use of a bipolar device instead of a bovie.
* RACE was not executed. The fire alarm was not pulled, a code red was not called, and OHSU EHS, facilities, and Portland fire were not informed of incident until following day.
* The cautery pen was discarded after the incident, and all other equipment and supplies associated with the incident were not sequestered for evaluation and investigation until the next day.

Action items included, but were not limited to the following:
* Purchase blenders for anesthesia high flow devices.
* Eliminate use of large ChloraPrep applicators for "head/face" procedures.
* Develop procedure to reduce fire risk in awake patients to consider: use of wet drapes over patients' faces, discussion in team pause regarding shut off of oxygen prior to cautery use, use of bipolar cautery instead of bovie.
* Restart fire drill and simulations in the ORs
* Focused education to providers who perform tracheostomies

The documentation was not clear or complete as follows:
* The reference to the "larger" ChloraPrep applicator "recommendation" to not use on the "head/face" was not accurate as manufacturer's instructions, specified in the findings that follow below, clearly stated "do not use 26-ml applicator for head and neck surgery" and there was no language to reflect that was a suggestion or recommendation. Further, the incident documentation referred to "head/face" procedures instead of "head and neck" procedures specified by the manufacturer.
* The spaces next to the action items listed above for "When" the actions were planned to be implemented were blank. There was no documentation to reflect that any of those actions had been implemented as of the entrance date of the survey.

2.b. Additional documentation dated 01/19/2023 reflected that comprehensive corrective actions continued to be discussed and planned, however, it included the following actions items that had not been completed, or continued to be "pending," as of the entrance date of this survey.
* Eliminate use of large ChloraPrep applicators for prep in tracheostomy procedures.
* Develop and implement procedure to reduce fire risk during awake tracheostomies.
* Restart fire simulations in the OR. First planning meeting scheduled for 01/26/2023.
* Inservice and Grand Rounds for OR and medical staff education and discussion of the incident, action items, and best practices was planned for 01/23/2023.
* Two oxygen blenders ordered on 12/22/2022 had an expected delivery date of four to six weeks.

3.a. The current "Surgical Safety Checklist Policy" dated as "Effective" 10/13/2021 was reviewed. It included the following information and direction:

* "Surgical Safety Checklist is a patient safety communication tool utilized by the surgical team, in the perioperative environment to discuss important details about a surgical case at three distinct phases during surgery: Pre-induction (pre-procedural verification, marking the procedure site), Time Out (Team Pause) and Debriefing. The Surgical Safety Checklist is used to facilitate the surgical team discussion so that everyone is familiar about [sic] the case, and reduces reliance on memory for certain necessary interventions."

* Regarding the first phase of "Pre-induction (pre-procedural verification, marking the procedure site):"
"1. Pre-Procedural Verification Process ... The person caring for the patient will ensure that all relevant documents and studies are available prior to the start of the procedure and that they have been reviewed and are consistent with each other, with the patient's expectations, and with the team's understanding of the procedure. A pre-procedure verification checklist, hard copy or electronic, can be initiated at the time a procedure is scheduled and will be completed prior to the start of the procedure. The list will be used to review and verify the following items are available and accurately matched to the patient: i. Relevant documents: ...Accurately completed and signed patient informed consent as defined in the Consent Policy ..."

* Regarding the second phase of "Time Out (Team Pause):"
"4. Team Pause Prior to the Start of the Procedure
a. This is the final verification that the correct patient, site, procedure, positioning are identified appropriately, and agreed upon and, as applicable, all relevant documents, related information and necessary equipment are available.
b. The Team Pause will be conducted in the location where the procedure will be performed prior to starting the procedure.
c. The Team Pause is initiated by the Provider starting the procedure or circulating nurse (OR and procedure areas) and involves the immediate members of the procedure team (e.g., Proceduralist, Anesthesia Providers, Circulator and Scrub in the Operating Room, the nurse caring for the patient, and other participants as appropriate who will be participating in the procedure at its inception).
d. The Circulating Nurse or equivalent personnel in ambulatory, ancillary, inpatient areas when included in the procedure will be the final gatekeeper for ensuring that:
i. the Team Pause takes place in a fail-safe mode
ii. all members participate
iii. the Team Pause is complete, and all required elements are documented in the integrated health record.
iv. This person has the authority to prevent the procedure from starting until the Team Pause is properly executed. This person has the responsibility to report any variance via Patient Safety Intelligence.
e. The Team Pause will be conducted in a "fail-safe" mode. This means:
i. All activity in the room is suspended to the extent possible without compromising the safety of the patient until the final verification has been done.
ii. All members of the team are actively engaged in the Team Pause. If it is identified that members of the team in the room are not actively engaged in the pause, the pause must be restarted from the beginning.
iii. If anyone enters or exits the room during a team pause, the pause must be restarted from the beginning.
iv. The Team Pause involves verbal agreement between all team members. Any member of the team with concerns or unanswered questions is encouraged to speak up. If there is any discrepancy in the information identified by any member of the surgical team, all discrepancies or disagreements will be resolved before proceeding.
f. The Team Pause includes the following elements which are to be documented in the integrated health record along with the names of Team Pause participants:
i. Correct patient identity (checked against the consent form)
ii. Identification of the correct site and side(s) (checked against the consent form)
iii. Procedure to be performed (checked against the consent form)
iv. Proper patient position
v. Availability of appropriate diagnostic and radiology test results (e.g., radiology images and scans or pathology and biopsy reports)
vi. Relevant images and results are properly labeled and appropriately displayed
vii. Need for special medications or fluids for irrigation purposes
viii. Administration of prophylactic antibiotics if indicated
ix. Safety precautions based on patient history or medication use
g. In cases involving multiple procedures or more than one Service, the Team Pause will be repeated at the beginning of a new procedure."

The policy and procedure did not ensure that all safety concerns and risks associated with the procedure were identified and addressed by the surgical team, including risks of fire.

3.b. Regarding the third phase of "Debriefing:"
There was no information in the P&P about the "Debriefing" that was described in the P&P statement: "Surgical Safety Checklist is a patient safety communication tool utilized by the surgical team, in the perioperative environment to discuss important details about a surgical case at three distinct phases during surgery: ... Debriefing."

A "Surgical safety time-out documentation - debrief phase" document was reviewed. It reflected that "The debrief phase is outlined only the [sic] in the definitions section of the Surgical Safety Checklist Policy - there are not other policies or procedures that reference or further define the debrief." In an email from the ADRA on 01/26/2023 at 1335 they confirmed that "... no, the debrief is not outlined further in another policy."

4. The "2020 Surgical Safety Checklist: Team Pause (SOR) Before invasive positioning, procedure or incision" tool was divided into sections designated by the team member responsible for conducting each part of the "pause." It included the following prompt for staff:
* "State fire risks: Heat/ignition sources - Open oxygen sources - Alcohol skin prep, Site above xiphoid process"

Although the tool prompted staff to "State fire risks" there was no prompt for discussion about how such risks would be mitigated to prevent a fire, nor was there a prompt for review of actions in the event of a fire.

5. A "BD ChloraPrep Hi-Lite Orange 26 mL Applicator" that contained "70% v/v isopropyl alcohol" was reported and documented to be the surgical prep solution used for Patient 1. Review of the "BD" products website reflected that the 26 mL applicator was the largest of the sizes of ChloraPrep applicators produced. A sample of an unused applicator in its packaging was provided and observed. The package label included the following:

* A section of the package within a red border contained the words "WARNING FLAMMABLE" in large font within a solid red bar. The following directions were contained in that section:
* "Keep away from fire or flame.
* To reduce risk of fire, PREP CAREFULLY:
* do not use 26-ml applicator for head and neck surgery or on an area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
* solution contains alcohol and gives off flammable vapors
* avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
* do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
* do not allow solution to pool
* remove wet materials from prep area"
* The words "flammable vapors" and "Wet hair is flammable" used in this section were printed in red font.

* The "Active ingredients" section of the package identified "Isopropyl alcohol 70% v/v" as one of two ingredients.

* A second "Warnings" section of the package contained the following directions:
* "For external use only. Flammable, keep away from fire or flame.
* To reduce risk of fire, PREP CAREFULLY:
* do not use 26-ml applicator for head and neck surgery
* do not use on an area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
* solution contains alcohol and gives off flammable vapors
* avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
* do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
* do not allow solution to pool
* remove wet material from prep area"
* The words "flammable vapors" and "Wet hair is flammable" used in this section were printed in red font.

* The "Directions" section of the package repeated the following directions:
* "... Do not use 26-ml applicator for area smaller than 8.4 in. x 8.4 in. Use a smaller applicator instead.
* do not use 26-ml applicator for head and neck surgery ...
* do not allow solution to pool ...
* allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away ..."

* A danger/warning sign, depicted by an image of flames within a red, diamond shape, was printed on the package in two places.

6. The "ChloraPrep 26mL Applicator" with "70% isopropyl alcohol" manufacturer's instructions case leaflet was reviewed and included the following:
* "Safety points for products containing alcohol:
* Do not drape or use ignition source until solution is completely dry (minimum of 3 minutes on hairless skin)
* Hairy areas may take up to 1 hour to dry
* Do not allow solution to pool
* Remove wet materials from prep area ...
* Do not use 26mL applicator for head and neck surgery ...
* Keep solution out of eyes, ears and mouth ..."

7. A smaller/lesser volume sample of a "BD ChloraPrep Hi-Lite Orange 10.5 mL Applicator" that contained "70% v/v isopropyl alcohol" was provided and observed. The package label included the following, and did not prohibit use on the head and neck:
* A section of the package within a red border contained the words "WARNING FLAMMABLE" in large font within a solid red bar. The following directions were contained in that section:
* "Keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY:
* solution contains alcohol and gives off flammable vapors
* avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable.
* do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
* do not allow solution to pool
* remove wet materials from prep area"
* The words "flammable vapors" and "Wet hair is flammable" used in this section were printed in red font.

8. A "Job Breakdown Sheet" for "Process Name: Surgical Prep Dry Time" had an "Effective Date" of 03/14/2022. The document included the following information:
* "1. Complete surgical prep and announce start of dry time.
1.1. State the time by the minute.
· In anesthetizing locations, which use alcohol-based skin preparations, it is required to implement fire risk reductions strategies.
· This includes using the unit dose of skin prep solutions, following manufacture/supplier instructions and warnings for application of skin prep, using sterile towels to absorb drips and runs during application and then removing them from the anesthetizing location prior to draping, and documenting these activities in the medical record to verify that all of the above has occurred prior to initiating the surgical procedure."

* "2. Prior to draping, the scrub and surgeon should announce dry time complete.
2.1. Reference the current time and ensure 3 minutes has passed since the dry time started.
2.2. Visually inspect the prep site to ensure prep solution is dry (no drips/runs/pooling).
2.3. Exception: when a staff member is holding a heavy limb/head/etc., it is appropriate to drape prior to 3 min. It is required to ensure that the 3 min timeframe is complete prior to procedure start.
· Alcohol solutions give off flammable vapors.
· Chloraprep manufacturer instructions: 3 minutes minimum dry time for hairless skin, up to one hour in hair. Ensure incision site hair is dry and blot as needed.
· Do not drape or use an ignition source (e.g. cautery, laser) until the solution is dry.
· Holding a prepped limb/head/etc. is heavy and requires the staff to extend from their body (poor ergonomics) and could cause injury."

* "3. Document in EPIC
3.1. "Was skin prep dry prior to draping" yes/no
· This is required documentation as part of the site prep section
· Indicating yes confirms that fire risk mitigation strategies were completed."

9. The ESU manufacturer's user manual titled "User's Guide Valleylab Force FX Instant Response Electrosurgical Generator" was reviewed. Chapter 3, "Patient and Operating Room Safety," identified numerous dangers and warnings that included the following:
* "Danger: Explosion Hazard - Do not use electrosurgery in the presence of flammable anesthetics.
* Warning: Fire/Explosion Hazard - The following substances will contribute to increased fire and explosion hazards in the operating room:
· flammable substances (such as alcohol based skin prepping agents and tinctures)
· naturally occurring flammable gases which may accumulate in body cavities such as the bowel
· oxygen enriched atmospheres
· oxidizing agents (such as nitrous oxide [Np] atmospheres)
* The sparking and heating associated with electrosurgery can provide an ignition source. Observe fire precautions at all times. When using electrosurgery in the same room with any of these substances or gases, prevent their accumulation or pooling under surgical drapes, or within the area where electrosurgery is performed ...
* Warning: Fire/Explosion Hazard - Verify that all oxygen circuit connections are leak free before and during the use of electrosurgery. Verify that endotracheal tubes are leak free, and that the cuff is properly sealed to prevent oxygen leaks. Enriched oxygen atmospheres may result in fires and burns to patients or the surgical team."

10. The disposable cautery device manufacturer's instructions titled "Valleylab Pencil" included the following:
* "Warning ... Fire Hazard Do not place active accessories near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories which are activated or hot from use can cause a fire. Use the E2400 Accessory Holster to hold electrosurgical pencils and similar accessories safely away from patients, personnel, and surgical drapes. When not in use, place active accessories in a holster or in a clean, dry, nonconductive, and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns. Confirm proper electrosurgical generator power settings before proceeding with surgery. Use the lowest power settings to achieve the desired surgical effect."
* "Caution An improperly installed electrode may result in injury to the patient or operating room personnel by arcing at the electrode and pencil connection."

11.a. On 01/19/2023 the surgical services "procedure cards" for "Tracheostomy" procedures performed throughout the hospital were provided. Those "cards" were multi-page, electronic documents that contained the lists of supplies and equipment needed for each type of surgical procedure performed in the hospital. All of the tracheostomy procedure cards identified the use of 26 mL alcohol based solutions or did not specify the size at all.

11.b. The surgical services "procedure card" for "Tracheostomy" for the hospital's "Otolaryngology Surgery" service, the service responsible for Patient 1's surgical procedure, was provided. It reflected under "Review History" that it had last been reviewed by an RN on 01/04/2023 at 1448, after Patient 1's incident. The "Audit Trail" for that card reflected that prior to the 01/04/2023 review it had last been edited on 10/03/2022, prior to Patient 1's surgery. The document included the following information:
* "Applies to all surgeons" in that service.
* "Procedures" were identified as "Tracheostomy" and three other tracheostomy related procedures.
* "Equipment" included a "ValleyLab Force FX" ESU.
* The "Supplies" list lacked an item for the site prep.
* "Circulator Instructions" included: "Site Prep Chloroprep [sic]"

11.c. The surgical services "procedure card" for "Tracheostomy Percutaneous ..." for the hospital's "Otolaryngology Surgery" service reflected under "Review History" that it had last been reviewed by an RN on 02/11/2022. The document included the following information:
* "Applies to all surgeons" in that service.
* "Procedures" were identified as "Percutaneous Tracheostomy."
* "Equipment" included a "ValleyLab Force FX" ESU.
* "Supplies" included "Solution Prep 3M DuraPrep 74% Isopropyl Alcohol 0.7% Iodine Povacrylex 26ML 1 Step Self Contain"
* "Circulator Instructions" included: "Site Prep: duraprep or chloroprep [sic]"

11.d. The surgical services "procedure card" for "Tracheostomy" for the hospital's "Oral Surgery" service reflected under "Review History" that it had last been reviewed by an RN on 06/08/2022. The document included the following information:
* "Applies to all surgeons" in that service.
* "Procedures" were identified as "Tracheostomy" and eight other tracheostomy related procedures.
* "Equipment" included a "ValleyLab Force FX" ESU.
* "Supplies" included "Solution Prep 3M DuraPrep 74% Isopropyl Alcohol 0.7% Iodine Povacrylex 26ML 1 Step Self Contain"
* "Circulator Instructions" included: "Site Prep Chloraprep"

11.e. The surgical services "procedure card" for "Tracheostomy" for the hospital's "Cardiac Surgery, Thoracic Survey" service reflected under "Review History" that it had last been reviewed by an RN on 09/29/2022. The document included the following information:
* "Applies to all surgeons" in that service.
* "Procedures" were identified as "Tracheostomy" and one other tracheostomy related procedure.
* "Equipment" included a "ValleyLab Force FX" ESU.
* "Supplies" included "Solution Prep 3M DuraPrep 74% Isopropyl Alcohol 0.7% Iodine Povacrylex 26ML 1 Step Self Contain"
* "Circulator Instructions" included: "Site Prep: Duraprep or Chloroprep [sic]"

11.f. The surgical services "procedure card" for "Tracheostomy" for the hospital's "General Surgery, Acute Care Surgery" service reflected under "Review History" that it had last been reviewed by an RN on 12/01/2021. The document included the following information:
* "Applies to all surgeons" in that service.
* "Procedures" were identified as "Tracheostomy" and eight other tracheostomy related procedures.
* "Equipment" included a "ValleyLab Force FX" ESU.
* The "Supplies" list lacked an item for the site prep.
* "Circulator Instructions" included: "Iodophor Swab from Pack or Chloraprep"

11.g. The surgical services "procedure card" for "Tracheostomy Percutaneous ..." for the hospital's "General Surgery, Acute Care Surgery" service reflected under "Review History" that it had last been reviewed by an RN on 02/14/2022. The document included the following information:
* "Applies to all surgeons" in that service.
* "Procedures" were identified as "Percutaneous Tracheostomy."
* "Equipment" included a "ValleyLab Force FX" ESU.
* The "Supplies" list lacked an item for the site prep.
* "Circulator Instructions" included: "Site Prep Chloroprep [sic]"

11.h. In regards to the "3M DuraPrep ... 26ML" alcohol based prep solution identified in some of the cards above, the 3M DuraPrep website included similar warnings and restrictions to the ChloraPrep brand manufacturer's instructions specified in Finding 5 above. For example: Information on the 3M website for "Duraprep Surgical Prepping Solution, 8630, 26 mL" included "Do not use the 26 mL applicator for head and neck surgeries. The volume of liquid is difficult to control in this application. Instead, use the 6 mL applicator" and "Warning Flammable ... flammable vapors ... wet hair is flammable ..."

12.a. The EHR for Patient 1 reflected that they presented to the ED on 12/12/2022 with a "Chief Complaint" of "Airway Problem." The EHR included the following information about the patient's encounter:

12.b. The "ED Course and Medical Decision Making" note electronically signed by the ED physician on 12/12/2022 reflected that "Upon arrival to the emergency department the patient the patient had audible stridor but no angioedema or tongue swelling ... ENT was consulted and evaluated patient at bedside with a scope and found [patient] to have significant edema. They recommended admission to OR for tracheostomy. Patient was taken to OR ... Admit Requested: Dec 12, 2022 1:50 PM ... Plan, disposition and follow-up: - admit to OR with ENT for tracheostomy."

12.c. The "Anesthesia Preop Evaluation" electronically signed by the MD Anesthesiologist on 12/12/2022 at 1420 included, but was not limited to, the following information:
* "Procedure: Awake Tracheostomy"
* "Anesthesia type: General"
* "Pre-op diagnosis: Airway Obstruction"
* "Anesthesia Plan ... Emergent ..."
* "Anesthetic Technique ... MAC"
* "Anesthetic Considerations - Known difficult airway and Awake tracheostomy"
* "Informed Consent - PARQ and risks/benefits of anesthetic plan discussed with Patient"

The documentation was not clear or complete as there was no documentation to reflect what risks were discussed with the patient for this "awake" procedure that involved use of MAC and general anesthesia, including fire risks.

12.d. A form titled "Patient Informed Consent For Rendering of Medical Services/Surgical Services/Sedation" signed by Patient 1 and an MD on 12/12/2022 at 1423 was reviewed.
* Procedure was described as "awake tracheostomy, direct laryngoscopy"
* Pre-printed language on the form reflected: "The physician or practitioner has explained to me, in a way that I understand, the planned procedure or treatment, anticipated benefits, material risks or potential problems that might occur during the procedure or treatment or during recuperation as well as the likelihood of achieving our goals. He/she has also discussed alternative therapies, including no treatment, as well as the anticipated benefits and risks associated with those alternative treatments. The following are among the risks or concerns discussed: (Specific risks or concerns discussed with the patient)." A handwritten entry reflected "pain, bleeding, infection, voice changes, damage to surrounding structures."
* Pre-printed language on the form reflected: "I acknowledge and agree to the following statements marked by the Practitioner as applicable to my procedure: ... Sedation or anesthesia will be managed by the Anesthesiologist. The Anesthesiologist will discuss the risks, benefits and alternative and answer my questions prior to my procedure."

The documentation was not clear or complete as the consent form did not clearly reflect that all risks associated with this procedure were identified, including fire risks.

12.e. A six-page surgical "Case Information" document generated from the EHR for the "Awake Tracheostomy" performed on 12/12/2022 was reviewed. It included, but was not limited to, the following information:
* "Case Tracking Events
- Patient in OR 1450
- Procedure Start 1518
- Start Closing 1537
- Procedure Stop 1601
- Patient out of OR 1617"
* "Intraop Verification 1 information ... 12/12/2022 1455"
* "Anesthesia General"
* "Op Region Neck"
* "Site Prep
- Intraop Site Prep
- Site: Neck
- Laterality: [blank]
- Hair Removal: Not applicable
- Scrub/Paint Solutions (*denotes preferred): ChloraPrep
- Prepped by: Pre-Op Prep - Preparation Staff"

* "Timeouts ...
- Timeout type: Pre-incision ...
- Team Pause
- Preparation
- Correct site and side?: Yes
- Site Marking Visible?: Yes
- Availability of correct implants and any special equipmen