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Based on interview and record review, the facility failed to assess and intervene as it related to temperature monitoring and safe settings of an infant radiant warmer. As a result, a premature newborn (Patient 1) was placed under an unregulated radiant heat warmer after birth, suffered a temperature spike to 107.2?F (Fahrenheit), as well as partial burns (known as a second degree burn, which affects the top two layers of skin, the epidermis and hypodermis) and full thickness burns (known as a third degree burn, which involves destruction of the entire skin, extending into subcutaneous tissue, muscle, or bone) to the groin and thigh area.


The clinical record was reviewed with Administrative staff on 10/31/13. Patient 1 was born on 10/9/13 at 11:18 A.M. by Cesarean section. The baby was born premature at 24 weeks and weighed 510 grams (1 pound) at birth. Patient 1 was then admitted to the Neonatal Intensive Care Unit (NICU).

According to the NICU vital signs record, the first temperature documented of Patient 1 after birth was 96.8?F axillary (under the arm) at 12:01 P.M. Staff documented that the newborn was under the radiant warmer. At 1 P.M., the patient's temperature was unchanged at 96.8?F axillary. There was no temperature documented for another 2 hours, when at 3:15 P.M. the patient's temperature was 107.2?F, still under the radiant heat warmer. At 3:36 P.M., the patient's temperature was still elevated at 102.4?F. The next documented temperature was one hour later, at 4:35 P.M. when it returned to normal 98.2?F.

Four days after Patient 1 was born, according to a Family Conference Note, dated 10/13/13, the physician explained to Patient 1's parents that, "The groin which appeared to be typical bruising and edema combined with poor perfusion in a 24 week infant now appeared to be a burn likely from the heating element of the isolette..."

A burn specialist physician was consulted and documented on 10/15/13 that Patient 1 had "Partial thickness burns to right knee, pubic region and labial area." On 10/29/13, according to the progress note by the burn specialist, "She had a burn to the anterior torso, medial/anterior bilateral thighs and perineum. This was due to a heating lamp." The physician further documented, "All of the burn wounds were partial thickness except the perineum which is a full thickness injury to both labia tissue...and in the process of liquefactive necrosis" (dead tissue that becomes a liquefied).

On 11/14/13 at 2 P.M., Registered Nurse (RN) 1 stated during an interview that she received Patient 1 upon admission to the NICU. Per RN 1, she did not put the temperature probe on the baby right away. "I had set the radiant warmer to 50% output while in manual mode." According to RN 1, about 3 1/2 hours after admission, she took Patient 1's axillary temperature and it was 107.2?F. RN 1 shut off the warmer and saw the temperature probe sensor on the bed, not on the baby, and the radiant warmer still in manual mode.

During an interview on 11/14/13 at 3 P.M., the Director of Maternal/Child Services (DMCS) stated that the manual mode uses a continuous heat source from the radiant warmer set as a percentage by the nurse. The temperature probe does not communicate in this mode, but displays the baby's temperature. In the baby mode, the radiant warmer is controlled by the baby's temperature through a sensor probe on the baby's skin.

According to the DMCS, the radiant warmer setting was in manual mode for continuous radiant heat upon Patient 1's admission to the NICU. The DMCS stated that the setting should have been changed to baby mode, using the temperature probe on the baby to regulate the warmer. When Patient 1's temperature was found to be 107.2?F, the setting was not in baby mode but still in manual mode, so heat "was just coming out."

On 1/22/14 at 1:45 P.M., RN 2 was interviewed regarding the radiant warmer. According to RN 2, there is an alarm function in manual mode after the radiant warmer has been on for a period of time. There is an audible alarm and visual alarm that activates "Check baby" on the screen.

According to the manufacturer's instructions for the incubator/radiant warmer bed, "When operating as a radiant warmer...the manual mode requires constant attention. In the manual mode, you must take the responsibility for detecting changes in the environment or the patient condition requiring heater adjustments in response to these changes."

According to the facility's policy Admission Procedure to Neonatal Intensive Care Unit (NICU) for the Nursing Staff, dated 9/12, "Temperatures of all patients will be maintained within a neutral thermal environment." In addition, "Radiant warmer bed turned on to servo control (baby mode), temperature probe and adhesive probe cover attached...Check that servo control (baby mode) of warmer is set at 36.5-37.0? Celsius(97.7-98.6?F); and control set to skin." The policy further indicated, "Continue nursing assessment every 15 minutes until stable."