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Based on observation, record review, interview, policy review, and review of manufacturer's instructions, the facility failed to ensure the appropriate size condom catheter was used to prevent skin breakdown.

See A392.

Based on observation, record review, interview, policy review, and review of manufacturer's instructions, the facility failed to ensure the appropriate size condom catheter was used to prevent skin breakdown. This affected two (Patients #1 and #3). The hospital census was 141.

Findings include:

1. Review of the medical record of Patient #1 revealed the patient presented to the emergency department (ED) on 06/15/24 at 4:28 PM with worsening shortness of breath over last couple of days. The patient was admitted to the Stepdown Unit at 9:22 PM. A nursing note at 10:16 PM stated the patient reported wearing a brief for incontinence at home.

Review of physician orders revealed an order to apply external urinary catheter The lines/drains/airways flow sheet revealed a size small condom catheter was applied by a staff Registered Nurse (Staff J) at 11:00 PM. The patient's skin around the genitalia was intact. A nursing assessment on 06/16/24 at 8:00 PM revealed the patient's penis was swollen. The condom catheter was removed at 10:00 PM. The reason for removal was compromised skin integrity. A wound nurse consult was ordered. A note composed by a wound nurse on 06/17/24 at 9:25 AM stated there was a new mucous membrane pressure injury over the lower and right lateral penis beneath the foreskin.

2. Review of the medical record of Patient #3 revealed the patient arrived to the ED from home on 06/20/24 at 11:09 AM with altered mental status and lethargy. The patient was admitted to the Intensive Care Unit at 5:33 PM.

Review of physician orders revealed an order to insert a Foley catheter on 06/20/24 at 3:38 PM. The patient was anuric in nursing assessments. The Foley catheter was inserted as ordered on 06/20/24 at 11:48 AM. A physician ordered for the Foley catheter to be discontinued on 06/21/24 and it was removed at 4:30 PM. A condom catheter was placed on 06/21/24 at 5:00 PM. The condom catheter was removed on 06/23/24 at 7:00 AM. A note on 06/24/24 at 8:45 AM composed by a wound care registered nurse stated a deep tissue injury on the penis due to the condom catheter was assessed.

During an observation on 08/06/24 at 4:00 PM, the supply room of the Stepdown/ICU Unit contained three storage bins containing condom catheters in sizes small, medium and large. During an interview on 08/06/24 at 4:00 PM, Registered Nurse Staff I stated she approximates the size when determining what size condom catheter to use on a patient. She said there are times when she starts out with a larger size and if there is no urine leaking around it, it is fine. If there is leaking noted, she goes down a size. Staff G, present during the tour, explained that all condom catheters are delivered to main campus from the manufacturer. Staff at main campus removes individual catheters and deliver them to this location. There is a measuring wheel that comes with the condom catheters, however, the wheel is not included with the delivery of condom catheters. There were no wheels to ascertain appropriate condom catheter sizes in the facility.

During an interview on 08/06/24 at 6:05 PM, Staff G confirmed that staff members did not follow either the facility policy or manufacturer's instructions as there is no measuring tool to ensure correct sizing for condom catheters. This resulted in hospital-acquired pressure injuries in two patients.

The facility policy titled "Indwelling and External Urinary Catheter Care, Maintenance & Removal Protocol", effective 12/17/19, stated an external urinary catheter is a drainage device that resides outside the body but allows for safe drainage of urine to a collection system. Staff members are instructed they must verbalize that the clinical indications for placement are urinary incontinence and limited mobility. Staff members are to use the sizing guide to determine the appropriate size. Condom catheters are to be changed at least every 24 hours.

According to the manufacturer instructions for the Bard condom catheter, the catheters are available in different sizes. Healthcare workers are instructed to measure the circumference of the penis at the base of the shaft. This is the place that the girth is the largest. It is important to ensure that the condom fit is secure but not too tight to avoid penile ulceration, scarring or penile tissue loss.