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Based on interview and documentation review it was determined that the Hospital had not yet fully implemented preventive actions to prevent future adverse patient events, associated with the endotracheal tube anchoring device.

Findings included:

Documentation indicated Patient #1, following surgery was unable to be extubated and remained on a ventilator, was returned to the SICU.

The SICU Nurse Manager was interviewed in person on 10/2010 at 8:40 AM. He/she said all SICU patient who were intubated had an endotracheal tube anchoring device utilized to secure the tube as was done in Patient #1 case. The endotracheal tube anchoring device was designed to be applied to a patient's face/cheeks with skin protecting adhesive pads attached to the device and was designed to prevent pressure wounds, by protecting the skin at the attachment site and allowed the endotracheal tube to be repositioned to prevent pressure wounds around the mouth and eliminated the need for anchoring the tube with adhesive tape. The device also prevented unexpected extubation. He/she said the anchoring device had been used at the Hospital for several years and there had never been a similar pressure wound associated with the device.

The Risk Manager was interviewed in person on 10/20/10, 10/21/10 and by telephone on 11/15/10.. The Risk Manager said a pressure wound on a patient's face had never occurred with this device prior to this event and the device had been in use at the Hospital for the last 3 years. This case had formally been reviewed. The Risk Manager said and documentation indicated the case was discussed with the SICU nursing staff highlighting the use of the device with patients with multiple risk factors.

The Manufacturers instructions for use of the Oral Endotracheal Tube Fastener device was reviewed. The instructions indicated the endotracheal tube fastener device provided a means to hold the endotracheal tube securely in place without the use of adhesive tape and allowed the repositioning of the tube in either direction along the device's track without removal of the device. The device was equipped with two skin barrier self adhering patches (DuoDerm) attached to the device to anchor the device to a patient's face and a neck band for securing the device in place. The instructions stated to minimize the risk of pressure injury inspect the patients lips and skin at least every 2 hours or more frequently if the Patient's condition dictates.

The Hospital policy that addressed assessment and reassessment of patients with potential risk for impaired skin integrity was reviewed. The policy stated all inpatients will have a skin risk assessment completed within 24 hours of admission and every 24 hours thereafter. A patient's risk is determined by a Braden Score.

Review of medical record documentation indicated Patient #1 was assess and reassessed per hospital policy and at times had a skin reassessment performed three or more times in a 24 hours period. However documentation did not indicate the endotracheal tube holder device or the skin associated with the device was inspected/assessed at 2 hours intervals as specified in the Manufacturers instruction.

The Staff Registered Nurse (RN#1) who had initially discovered and identified an area of concern on Patient #1's left cheek on 9/19/10, was interviewed in person on 10/21/10 at 10:10 AM. RN #1 said he/she had noticed an area along the top edge of the skin barrier patched attached to the endotracheal tube holder device on Patient #1's left cheek appeared bruised. RN #1 said he/she routinely checked the tube holder on a regular basis whenever he/she was in a patient's room who had the device.

Review of 9/19/10, 10:20 PM nursing documentation indicated there was an area of ecchymosis and excoriated skin under the endotracheal tube's DuoDerm anchoring patch on Patient #1's left cheek. The area was purple in color measuring 2 cm by 3 cm.

Review of 9/20/10, 9:39 AM nursing documentation indicated there was a 2 cm by 3 cm deep tissue pressure ulcer of Patient #1's face.

The Risk Manager said there was no specific line/field in the electronic medical record to enter documentation related to the endotracheal tube holder device. There was no way to track how often the device was changed or how often the device was assessed.

RN #1 said he/she and the respiratory therapist removed the tube holder and replaced the device positioning the new device in a different location on Patient #1's face. The area under the original barrier patch on the left cheek looked like a 2 centimeter (cm) by 2 cm bruise. The area was dark purple and the skin was still intact.

The Risk Manager said the incident was discussed with the SICU nursing staff, at which time the need to carefully check all patient's skin utilizing this device was highlighted.

The SICU Nurse Manager said the ICU Committee will be discussing the need for formal guidelines/policies and procedures related to the utilization of the endotracheal tube holder.

Based on documentation review it was determined the Hospital failed to ensure nursing care was provided to all patients as needed in one of twelve records reviewed.

Findings included:

The Manufacturer's instructions for use of the Oral Endotracheal Tube Fastener device was reviewed. The instructions stated to minimize the risk of pressure injury inspect the patients lips and skin at least every 2 hours or more frequently if the Patient's condition dictates.

Review of Patient #1's nursing documentation did not indicate the endotracheal tube holder device or the skin associated with the device was inspected/assessed every 2 hours as specified in the Manufacturer's instructions.

Based on documentation review it was determined the Hospital failed to ensure the medical record included assessments of the endotracheal tube anchoring device in one of twelve medical records reviewed.

Findings included:

Refer to A-288