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Based on medical record review, facility policy review, and staff interview, the facility failed to ensure staff nurses followed the current facility policy related to thermoregulation and followed a physician's order for monitoring vital signs (A0392).

Based on medical record review, facility policy review, and staff interview, the facility failed to ensure staff followed the current facility policy related to thermoregulation of the newborn and failed to follow a physician's order to monitor vital signs of one newborn admitted to the Special Care Nursery. This affected one patient, Patient #11.

Findings include:

Review of the medical record of Patient #11, an infant male, revealed the infant was born via cesarean section at 39.2 weeks gestation on 04/14/22 at 8:59 PM with Apgars of 9 at one minute and 9 at five minutes of life requiring no resuscitative measures beyond drying and stimulation. According to the Infant Vital Signs Flowsheet, at 9:04 PM, the infant's mother was holding him skin-to-skin while she remained in recovery from the cesarean section. At 9:59 PM, the infant was placed under a radiant warmer in the Special Care Nursery (SCN) as a Nurse Practitioner, was at the bedside performing the infant's initial assessment. The infant's skin was noted to be intact and within defined limits at the time of the assessment. The skin assessment further noted there were no rashes, petechiae, or other lesions, and the infant's skin was pink and well perfused.

Although the infant was noted to be having intermittent mild grunting, he was taken back to his mother's room for continued monitoring and bonding with his parents. At 11:40 PM, a Charge Nurse's Note (Staff G) stated: "Mild grunting/nasal flaring observed intermittently during transition period; recovery otherwise completed without complication. NNP at bedside at 2159 for full infant assessment with RN; no abnormalities/complications noted at that time. Following breastfeeding attempt at 2310, RN at bedside discussing feeding/pumping with mom. Infant placed in sleep sack in bassinet and noted to have increased continual grunting and nasal flaring as well as tachypnea. Pulse ox placed on R wrist with initial reading of 86%; did not rise above 91%. NNP phoned and updated on patient condition; NNP immediately to bedside. Infant taken to SCN."

A chest x-ray revealed the infant had a mild to moderate pneumothorax to the right side and he was placed on continuous positive airway pressure (CPAP) at 12:32 AM. After admission to the SCN, the medical record lacked documentation a staff nurse assessed and documented the infant's vital signs, documented the set temperature or skin temperature of the radiant warmer, or monitored the infant in any way until 4:00 AM, more than four hours after being transported to the SCN. At 4:00 AM, the Infant Vital Signs Flowsheet noted the infant's temperature was elevated at 100.4 degrees Fahrenheit. A nurse's comment at that time stated the NNP was notified but no new orders were given. The radiant warmer set temperature and skin temperature were noted on the Infant Vital Signs Flowsheet to both be 36 degrees Celsius (96.8 degrees Fahrenheit) at 4:00 AM.

At 8:00 AM, after a day shift SCN Staff Nurse (Staff I) began caring for the infant, a large blister-like wound measuring 4 cm x 5 cm was noted on the infant's lower back. The decision was made to transfer the infant to a tertiary facility for observation, evaluation, and management of the large wound to the back. According to the Medication Administration Record (MAR), the infant was medicated with Morphine 0.17 mg IV on 04/15/22 at 10:59 AM to treat the infant's pain. The infant was transferred to the tertiary facility on 04/15/22 at 11:00 AM.

Review of the medical record of Patient #11 from the tertiary facility revealed the infant remained an inpatient in the Neonatal Intensive Care Unit (NICU) for 10 days. On admission to the NICU, the infant's wound measured 7.5 cm x 5.0 cm with the top layer of skin sloughing off. The infant's wound was diagnosed as a partial thickness burn.

Staff G was interviewed via phone on 06/02/22 at 1:48 PM. Staff G recalled that Patient #11 became increasingly tachypneic, exhibiting signs of respiratory distress. Staff G stated that when she found the infant's oxygen saturation to be low, she called and informed the Neonatal Nurse Practitioner (Staff F) who ordered the Charge Nurse to transport the infant to the SCN for further assessment. Staff G reported that she placed the infant in the bassinet on wheels and transported the infant to the SCN. She then placed the infant in the Giraffe Omnibed Radiant Warmer where the NNP assessed the infant and made the decision to admit the infant to the SCN. According to the Charge Nurse, a trained SCN Staff Nurse, Staff H, was on-call for the SCN that night. Staff H was called in to care for the infants being admitted into the SCN. The Charge Nurse stated staffing was "hectic" but manageable. At almost the same time Patient #11 was admitted to the SCN, another infant was admitted to the SCN. Staff G reported having time to give a brief report to Staff H before having to attend another delivery in the OR. Staff G stated she placed the infant under the radiant warmer but could not recall if the radiant warmer was in automatic servo control mode (automatic servo control mode means the temperature in the warmer is automatically adjusted based on the temperature of the probe attached to the infant to a temperature set point that was initially set by staff) or manual control mode (manual control mode means that staff manually set the temperature in the warmer). She stated: "I honestly don't remember that detail."

Staff H, the SCN Staff Nurse, was interviewed on 06/02/22 at 1:49 PM. Staff H stated she was called in for additional staffing in the SCN on the night of 04/14/22 and arrived in the SCN at approximately 12:15 AM. Staff H stated that two infants were being admitted to the SCN when she arrived. Upon arrival, Staff H went into the room of Patient #11. Staff H stated that she was called from the room of Patient #11 to the room of the other infant almost immediately, as the other infant did not have IV access. Staff H explained that she was busy with the other infant until about 3:00 AM. When asked who was caring for Patient #11, Staff H stated: "I'm not sure who was in the room with that baby. That babe could have been alone for all I know."

An order to admit Patient #11 to the SCN with the SCN order set was noted at 12:11 AM on 04/15/22. The SCN order set included an order for initial vital signs within 15 minutes of admission to the SCN and then every hour for four hours.

The facility policy entitled "Thermoregulation of the Newborn", was reviewed on 06/02/22 at 11:23 AM. According to the policy, the goal of thermoregulation is to maintain a Neutral Thermal Environment, which minimizes heat loss
Thermoneutral conditions exist when heat production (measured by oxygen consumption) is minimum and core temperature is within the normal range.

* Thermal stable range for the newborn as defined at The Christ Hospital (TCH) is a temperature between
97.7 - 99.5 (36.3 - 37.4 degrees Celsius) axillary
* Air temperature in all nurseries should be maintained between 72-78 degrees Fahrenheit
* Axillary temperature should be utilized for all temperatures unless MD order obtained for alternate method

Ongoing Care

* Any temperatures outside of acceptable above range should be repeated in 30 minutes with documentation of measures taken. If a repeat temperature 30 minutes later is still out of range, notify physician.

Under the heading of management of a patient on a radiant warmer bed, the policy provided the following instructions:

1. Automatic Servo Control Mode

Patients on radiant warming beds should be maintained via servo skin control mode.

Radiant warmers should be prewarmed. Once infant is on radiant warmer, initial set point should be between 36.5-37.2 C.

Plug skin temperature probe into the warmer; secure temperature probe on infant's abdomen (over liver), chest, or lower back (over kidney) avoiding bony prominences using an approved temperature probe cover. Linen or other equipment should not cover probe.

Probe site should be in direct line with the heat source overhead.

2. Manual Control Mode

CAUTION! This mode should be used only under strict infant supervision for only brief periods of time
(i.e.-delivery room, bath, or procedure).

The policy instructs nursing staff that the warmer will alarm every 10 minutes while in the manual mode as
a reminder to prevent accidental over/under heating.

Under documentation, staff nurses are instructed to document the following with routine vital signs:

Skin temperature

Warmer temperature set point

Axillary temperature

Mode of control

Interview with Staff A on 06/3/22 at 3:00 PM confirmed that the medical record lacked documentation the physician's order was followed, as the infant's temperature was not assessed within 15 minutes of admission to the SCN and every hour for four hours. It was also confirmed that the medical record lacked documentation of the radiant warmer temperature set point, the mode of control, the skin temperature, and axillary temperature for more than four hours.

Based on record review and interview, the facility failed to ensure Giraffe OmniBeds located in the Special Care Nursery were maintained according to the manufacturer's instructions, which requires replacement of the fan motor every three years (A0701).

Based on review of the manufacturer's instructions for the Giraffe OmniBed Carestation, review of the equipment service reports, and staff interview, the facility failed to ensure two out of two Giraffe OmniBeds were maintained according to the manufacturer's instructions thereby ensuring the safety of newborns. This had the potential to affect all newborns receiving care in the Special Care Nursery.

Findings include:

The Giraffe OmniBed Carestation user manual was reviewed on 05/24/22 at 1:45 PM. According to the user manual, the device should be maintained in accordance with the procedures detailed in the manual. Service maintenance must be performed by a technically competent individual. The schedule list of minimum frequencies included replacement of the fan motor every three years. The fan motor circulates the air and heat in the unit.

The service history of the two Giraffe OmniBed Carestations located in the SCN was reviewed on 05/24/22 at 12:00 PM. According to the history, both OmniBeds were purchased and placed into service in 11/2017. The service history of Giraffe OmniBed #1 noted the fan motor was replaced on 12/23/21, more than a year after the fan motor should have been replaced. The service history of Giraffe OmniBed #2 revealed the unit was taken out of service on 04/20/22 after the unit was noted to be making a noise. Once the unit was taken out of service, an error message #25 was displayed indicating the fan motor needed to be replaced.

Patient #11, a full-term male infant born on 04/14/22, was admitted to the Special Care Nursery the morning of 04/15/22. The infant was placed in OmniBed #2. On 4/15/22 at 8:00 AM, the infant was found to have a large blister to his lower back. The infant was subsequently transferred to a tertiary facility on 4/15/22 where physicians diagnosed the wound as a partial thickness burn.

Interview with Staff A on 05/24/22 at 1:05 PM confirmed that the manufacturer's instructions were not followed, as the fan motors were not replaced every three years as required.