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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 Nursing Services was out of compliance.

A-0395 A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document review, the facility failed to ensure patients were assessed per physician's orders in three of three medical records reviewed where patients received Therapeutic Temperature Management (TTM) (Patient #2, #7, and #8). In addition, the facility failed to ensure established processes and guidelines for the management of female external catheters (a non-invasive way to manage urinary incontinence) were followed. Specifically, the facility failed to ensure female patients' external catheters were replaced as required per instructions for use (IFU). This failure was identified in one of one patients reviewed who had a female external catheter in use for more than 24 hours without being replaced (Patient #2).

Based on interviews and document review, the facility failed to ensure patients were assessed per physician's orders in three of three medical records reviewed where patients received Therapeutic Temperature Management (TTM) (Patient #2, #7, and #8). In addition, the facility failed to ensure established processes and guidelines for the management of female external catheters (a non-invasive way to manage urinary incontinence) were followed. Specifically, the facility failed to ensure female patients' external catheters were replaced as required per instructions for use (IFU). This failure was identified in one of one patients reviewed who had a female external catheter in use for more than 24 hours without being replaced (Patient #2).

Findings include:

Facility document:

The Therapeutic Temperature Management Protocol read, neuro checks (assessments conducted to determine nervous system impairment) are to be completed every one hour during cooling and warming phases.

References:

According to the Purewick Female External Catheter IFU the catheter was to be replaced at least every 8-12 hours or immediately if soiled with feces or blood. Placement and the patient's skin was to be assessed at least every two hours.

According to the Nursing Skills Sheet for External Female Catheter, Purewick position and perineal skin were to be assessed every two hours. Purewick was to be changed every 8-12 hours, earlier if needed.

1. The facility failed to ensure neuro checks were completed every one hour during therapeutic temperature management.

A. Record review revealed the patients' neuro status was assessed every four hours during their TTM treatment rather than every one hour as ordered by the provider.

a. A review of Patient #2's medical record revealed an order was placed on 10/7/21 at 4:00 p.m. for neuro checks to be completed every hour during warming and cooling phases of the TTM protocol. The order was discontinued on 10/9/21 at 11:13 a.m.

i. Review of the ICU assessment sheets in Patient #2's record revealed from 10/7/21 at 4:00 p.m. to 10/8/21 11:00 a.m., neuro assessments were completed every four hours.

b. A review of Patient #7's medical record revealed an order was placed on 2/6/22 at 11:00 p.m. for neuro checks to be completed every hour during the warming and cooling phases of the TTM protocol. The order was discontinued on 2/8/22 at 10:52 a.m.

i. Review of the ICU assessment sheets in Patient #7's record revealed from 2/6/22 at 11:00 p.m. to 2/8/22 at 11:00 a.m. neuro assessments were completed every four hours.

c. A review of Patient #8's record revealed an order was placed on 2/22/22 at 5:18 a.m. for neuro checks to be completed every 15 minutes. An additional order was placed on 2/22/22 at 7:00 a.m. for neuro checks to be completed every hour during the warming and cooling phases of the TTM protocol. Both orders were discontinued on 2/22/22 at 11:22 a.m.

i. Review of the ICU assessment sheets in Patient #8's record revealed from 2/22/22 at 5:18 a.m. to 11:22 a.m., neuro assessments were completed every four hours.

B. Interviews revealed during the TTM protocol, the patient was to be assessed every hour.

a. On 4/12/22 at 4:53 p.m., an interview was conducted with Registered Nurse (RN) #2. RN #2 worked in the ICU. RN #2 explained the TTM protocol was typically ordered when a patient experienced a cardiac arrest and did not have immediate neurological recovery. RN #2 stated neuro checks were to be completed on the patient every one hour. RN #2 stated there was a risk to patients if neuro assessments were not completed every hour.

b. On 4/13/22 at 9:15 a.m., an interview was conducted with Critical Care Provider (Provider) #3. Provider #3 stated TTM was when a patient was cooled, typically to 36 degrees Celsius, in order to create better neurological outcomes after a cardiac arrest. Provider #3 stated the patient was to be monitored every hour during the cooling phase of the TTM protocol, which was at least 24 hours. She further explained the neuro checks were to be completed to ensure there were no major changes in the patient's neuro status. Provider #3 stated it was important for the patient to be assessed during the TTM protocol because the patient was at risk for experiencing a change in condition such as a seizure, electrolyte imbalances, arrhythmias and even infection.

Findings in the medical records reviewed were in contrast to the TTM protocol which read neuro checks were to be completed every hour during the warming and cooling phases. Additionally, the medical records were in contrast to interviews conducted with staff which revealed neuro checks were expected to be completed every hour during TTM.


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2. The facility failed to ensure female external urinary catheters were changed every 8-12 hours in accordance with the catheter's IFU and facility expectations.

a. On review of Patient #2's medical record, the patient was admitted on 10/7/21. Review of the daily care/safety flow sheets revealed the patient had an external female catheter (Purewick) placed from 10/16/21 to 10/30/21.

According to the IFU's the external catheter was to be replaced every 8 to 12 hours or earlier if needed.

Continued review of Patient #2's medical record revealed no evidence the external female catheter was replaced on 10/16/21, 10/19/21, 10/20/21 - 10/24/21 and 10/26/21, 10/28/21 -10/30/21.

b. On 4/14/22 at 9:27 a.m., an interview was conducted with Registered Nurse (RN) #1 who worked with inpatients on the medical floor. RN #1 stated she was aware of the facility's expectation for external female catheters and stated the external female catheter was to be changed every shift or right away if it was soiled to ensure proper pericare (cleaning the private areas of a patient) and incontinence care.