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Based on document reviews, observation, and interviews, it was determined that the Condition of Participation for Patient Rights was not met as evidenced by the hospital's failure to ensure a patient's right to receive care in a safe setting. A fire in the operating room occurred and it was determined that a 26-milliter (mL) applicator of ChloraPrep, a skin preparation solution, was used on a patient's neck and head area which was contrary to manufacturer's recommendation. The hospital failed to have a system in place to ensure the manufacturer's recommendation was followed and this failure had the potential to affect the safety of all patients undergoing procedures above the head and neck when this particular skin preparation solution was used.

Findings:

Standard: §482.13(c)(2) Patients Rights: Care in a Safe Setting also known as A-0144 - Based on document reviews, observation, and interviews, the hospital failed to ensure a patient's right to receive care in a safe setting as evidenced by the use of a 26-milliter (mL) applicator of ChloraPrep on a patient's neck and head area which was contrary to manufacturer's recommendation for 1 of 1 patients (Patient #1). The hospital's failure to have a system in place to ensure the manufacturer's recommendation was followed had the potential to affect the safety of all patients undergoing procedures above the head and neck when this particular skin preparation solution was used. See A-0144 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

Based on document reviews, observation, and interviews, the hospital failed to ensure a patient's right to receive care in a safe setting as evidenced by the use of a 26-milliter (mL) applicator of ChloraPrep on a patient's neck and head area which was contrary to manufacturer's recommendation for 1 of 1 patients (Patient #1). The hospital's failure to have a system in place to ensure the manufacturer's recommendation was followed had the potential to affect the safety of all patients undergoing procedures above the head and neck when this particular skin preparation solution was used.

Finding:

The Division of Licensing and Certification was notified, by the hospital, of the following incident: "On 10/23/2020, patient undergoing left neck lymph node. Patient was brought into OR Room 1 at 1000. Patient was prepped with ChloraPrep, surgery above xiphoid, cautery used, open oxygen source. Fire risk was evaluated, and patient scored a 3 out of 3 (highest risk). Patient prepped using CholraPrep (prep time unknown), patient was draped using 1 towel scrunched into neck and four towels surrounding surgical site, impervious drape used. Prep was observed dry by surgeon. At 1028, local was injected and procedure began. At or around 1030 cautery was used and immediately after surgeon and CST saw flames, and alerted the room to the presence of the fire. CST poured saline onto the fire; drapes removed. At the time of the use of cautery the oxygen was set to 6 liters via face mask. At 1033 patient was intubated. Provider noted per his assessment that the patient received what appeared to 2nd and 3rd degree burn on face including eyebrows and eyelids and tongue. Incision site closed procedure aborted. ENT called to consult and no burns in airway noted."

On 10/29/2020, an on-site investigation into this incident was initiated. The investigation revealed the following safety issue:

On 10/29/2020 at 12:40 PM, Operating Room Registered Nurse (OR-RN) #1, who prepared Patient #1 for his/her surgical procedure, was interviewed. On 10/29/2020, she stated she used a 26-mL applicator of ChloraPrep (a skin preparation solution) when preparing the patient's left neck area for the surgical procedure.

On 10/29/2020 prior to 3:20 PM, surveyors requested and observed a 26-mL ChloraPrep applicator. The warning on the manufacturer's label stated, "To reduce the risk of fire, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery ..."

On 10/29/2020 at 3:20 PM, in a discussion with the Assistant Vice President of Perioperative Services ("AVP"), it was pointed out to her the label on the 26-mL applicator of ChloraPrep stated, "Do not use 26-mL applicator for head and neck surgery". She stated she would check with the manufacturer for clarification.

On 10/30/2020 at 10:45 PM, OR-RN #1 again confirmed that a 26-mL applicator of Chloraprep was used.

An email, dated 10/30/2020 at 11:00 AM, from a representative of the manufacturer of the applicator to a representative of the Maine State Fire Marshal's Office was reviewed. The email stated, "As we discussed, the 26-ml ChloraPrep applicator is contraindicated for the head and neck area or for areas smaller than 8.4" x 8.4", per the label. This means Bard/BD [manufacturer] does not recommend. Choosing to do so will be off label and will be up to the physician/facility."

On 11/2/2020 at 11:15 AM, the AVP stated, "The use of 26-mL ChloraPrep for head and neck surgeries was discontinued today."