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Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.21, Quality Assessment and Performance Improvement, was out of compliance.

A-0286 - PATIENT SAFETY (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ...
(c) Program Activities .....(2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. Based on document review and interviews, the facility failed to conduct a timely investigation into the causative factors of a pediatric patient's death and implement preventative actions to prevent the recurrence of any found patient care issues in one of one medical records reviewed of a patient who died in the emergency department (ED).

Based on document review and interviews, the facility failed to conduct a timely investigation into the causative factors of a pediatric patient's death and implement preventative actions to prevent the recurrence of any found patient care issues in one of one medical records reviewed of a patient who died in the emergency department (ED). (Patient #2) (Cross-reference A-0395)

Findings include:

Facility guidance:

According to an educational slide show titled Presenting Pediatrics, provided by the prior ED educator (Educator #9), Intravenous (IV) Administration Guidelines: Age 18 years and younger, all medication fluids must be on a (IV) pump.

1. The facility failed to ensure education and preventative measures were put into place after being made aware of the possibility of an air embolism (blockage of blood supply caused by air bubbles in a blood vessel or the heart) contributed to the cause of death for a pediatric patient.

a. Review of Patient #2's medical record revealed the patient was 16 months old and presented to the facility on 8/24/22 at 1:37 p.m., with a chief complaint of fever and flu-like symptoms. At 2:14 p.m., the patient's vital signs (temperature, blood pressure, heart rate, and respiration rate) were documented within normal limits. Documentation at this time noted the patient acted age appropriate and the airway was patent.

According to the Emergency Provider Report, the patient was alert, attentive, and the lungs were clear to auscultation (listening to internal sounds of the body). The ED course (treatment plan) included: basic labs, cultures (tests to assess for bacteria or fungi in the body), and two IV fluid boluses (an IV infusion that runs quicker than a standard IV infusion).

The Emergency Provider Report continued with documentation of a reevaluation. According to the reevaluation, the provider was called into the room as the Patient #2 became suddenly lethargic and his lips turned blue. Patient #2's parents reported the patient was eating a cracker and drinking formula when his condition changed. Patient #2's skin became dusky (dark in color) and the heart rate decreased.

According to the Emergency Notes, at 6:15 p.m., the registered nurse (RN) was called to the room by the patient's parents due to increased lethargy. Three RNs responded and the provider was also called to the room. The patient was non responsive to pain stimuli. At 6:24 p.m., the patient was pulseless and apneic (cessation of breathing).

Review of the CPR Record revealed at 6:24 p.m., the patient had no pulse and chest compressions began. At 7:37 p.m., six hours after the patient presented to the ED, the patient was pronounced dead.

b. Review of Patient #2's autopsy report dated 11/11/22 revealed the causative factors of the patient's death included extensive air bubbles throughout the cerebral vasculature (veins located in the brain) and pulmonary edema (excess fluid in the lungs).

c. On 11/17/2022 at 10:47 a.m., an interview with RN #1 was conducted, who stated she began working in the ED in February of 2022. RN #1 stated she did not recall receiving training on administering medications to pediatric patients when she began working in the ED. RN #1 also stated she was trained in the ED to hang IV fluids to gravity when administering them, rather than through an IV pump (medical device that delivers IV fluids to the body in controlled amounts). She said the reason to hang fluids to gravity was to have them infuse quickly.

RN #1 said she recalled providing care to Patient #2 in the ED on 8/24/22. RN #1 stated when she prepared the IV fluid bags for administration, she punctured the insertion site of the IV bag and emptied an amount of fluid so that the remaining fluid in the IV bag matched the amount which was ordered. She stated she could not remember if she used an IV pump or hung the IV fluids to gravity. She stated she could not recall if she had used an IV pressure bag (a bag used to compress an IV bag to allow for the IV fluid to infuse quickly).

After the first bag of IV fluids infused, RN #1 stated she informed the parents that Patient #2 could eat, then she began the administration of the second bag of IV fluid. RN #1 stated a short time later, the patient's mother frantically asked for assistance. RN #1 stated when she entered Patient #2's room, he was unresponsive.

RN #1 stated facility leadership staff spoke with her the next day on the details of the incident. RN #1 stated she attended a debriefing after the event. She explained the debriefing included a discussion of what went well and what could be improved regarding the incident. She said the biggest takeaway from the debriefing was the need for better communication between pharmacy staff and ED staff during a code blue (medical emergency including respiratory or cardiac arrest). RN #1 stated she had received training on the care of pediatric patients after the incident. When asked if she had received training on the administration of IV fluids, RN #1 stated the facility provided training regarding the importance of verifying IV medication doses with another nurse. RN #1 stated she also recalled hearing the ED received a pediatric specific IV pump but she had not yet been trained to use it.

d. On 11/17/22 at 1: 33 p.m., an interview with ED charge nurse (RN #2) was conducted. RN #2 explained the standard process for infusing IV fluids on pediatric patients involved using an IV pump so that the specific volume to be infused could be entered into the pump. RN #2 stated it was not standard practice to manually empty IV fluid from the bag prior to the infusion because there would not be a way of knowing the precise amount of fluid wasted. RN #2 stated it was important to know the specific amount of IV fluid administered because a pediatric patient could become fluid overloaded much quicker than an adult patient, which could result in pulmonary edema, congestive heart failure, and death.

RN #2 stated she recalled assisting with the care of Patient #2 during the code blue event. RN #2 stated she initiated an IV infusion which contained norepinephrine (a medication that treats low blood pressure and heart failure). RN #2 stated she had to leave the patient's room in order to get an IV pump because there was no IV pump in the patient's room.

RN #2 stated she attended a debriefing after the code blue event occurred. She stated the cause of the patient's death was briefly mentioned, however, the discussion was primarily focused on the code blue event itself. RN #2 stated the outcome of the debriefing included education on pediatric codes. RN #2 stated she also recalled a discussion of using an IV pump for IV infusions during a team huddle.

i. Review of the huddle documentation provided by the facility revealed no evidence of a topic regarding using an IV pump for pediatric patients.

e. On 11/17/22 at 9:49 a.m., an interview with RN #3 was conducted, who stated she conducted the initial triage assessment for Patient #2 and assisted with the code blue event. RN #3 stated she had heard Patient #2's cause of death was possibly due to an air embolism. She was unsure where she gained this knowledge, but stated it was possibly from a team huddle.

RN #3 stated she had been trained to use an IV pump for IV fluids administration to pediatric patients. She stated she would not use a pressure bag to administer IV fluids to pediatric patients because pediatric patients should not receive fluids that fast unless they were undergoing a code blue event. She explained the reason for infusing IV fluids on an IV pump was because pediatric patients had smaller veins that could become infiltrated, and there was a risk of fluid overloading the patient if the fluids were not administered on an IV pump.

f. On 11/17/22 at 3:50 p.m., an interview with Paramedic #6 was conducted. Paramedic #6 explained her role included administering medications, including IV fluids, to patients in the ED on the night shift. Paramedic #6 stated the standard of care was to ensure all IV fluids administered to patients under the age of 13 were infused from an IV pump. Paramedic #6 stated the reason for using an IV pump was to monitor the amount of fluid being infused because pediatric patients were at a higher risk of becoming fluid overloaded. Paramedic #6 stated another reason to use an IV pump was to avoid the risk of the patient receiving an air embolism.

Paramedic #6 stated she had not been provided any education regarding the administration of IV fluids for pediatric patients after Patient #2's death.

g. On 11/21/22 at 8:53 a.m., an interview with ED physician (Physician) #7 was conducted. Physician #7 stated she was unable to provide guidance on the appropriate way to hang IV fluids because physicians did not perform that task. Physician #7 stated approximately three weeks after Patient #2's death, she had heard from another physician at the facility that the cause of Patient #2's death was possibly due to an air embolism. Physician #7 explained the most common cause of an air embolism was from air in an IV line which made its way into the venous system. Physician #7 stated once the air entered the venous system, it could travel to the heart, lungs, and brain, which would cause a lack of oxygen. Physician #7 stated when the brain received a lack of oxygen, symptoms similar to a stroke could occur.

h. On 11/21/22 at 9:39 a.m., an interview was conducted with ED educator (Educator) #8, who stated she began the role of ED educator on 10/31/22, and ED educator (Educator) #9, who stated she was the ED educator in August of 2022. Educator #8 stated hanging IV fluids to gravity for pediatric patient IV fluid administration was not a standard of practice that she would train staff on. She stated she trained staff to use an IV pump or to push fluids manually through a syringe when IV fluids were administered to pediatric patients. Educator #8 stated the reason for using an IV pump or syringe for administering IV fluids to a pediatric patient was to ensure the proper dose was given. Educator #8 further stated using an IV pump or syringe would be a more efficient and faster way to administer IV fluids than hanging IV fluids to gravity.

Educator #8 then stated she was made aware of Patient #2's code blue event and death, however, she had not provided any education to staff in response to the code blue or death .

Educator #9 reiterated the importance of using an IV pump to infuse IV fluids for pediatric patients was to ensure the proper dose was infused and to avoid fluid overloading the patient. Educator #9 stated she had not provided education about reducing the risk of a patient receiving an air embolism after the events surrounding the care of Patient #2.

i. A request was made to review any pediatric education provided to the ED staff after Patient #2's death. Upon the request, a slide show was provided which included the topic of IV fluid administration for pediatric patients. However, only six staff members attended the training, which was provided on 10/13/22, fifty days after the event occurred. Review of the current staff roster revealed a total of 54 nurses and nine paramedics were employed in the ED.

j. On 11/21/22 at 9:19 a.m., an interview with the ED manager (Manager) #10 was conducted. Manager #10 stated it was acceptable to infuse IV fluids to pediatric patients through an IV pump or by hanging to gravity.

This was in contrast with the facility's guidance and from all other interviews conducted throughout the survey.

She explained usually a pump would be selected because the amount of fluid infusing would be more precise than hanging the IV fluids by gravity. Manager #10 stated the risk of infusing IV fluid too quickly for a pediatric patient included increasing the patient's heart rate.

k. On 11/17/22 at 4:43 p.m., an interview with the vice president of the quality department (VP) #4 and the director of patient safety and risk (Director) #5 was conducted. VP #4 stated a serious event analysis (SEA) was conducted one week after Patient #2's death. VP #4 stated the SEA was not focused on determining the cause of death, but rather the process from the code blue event. VP #4 further stated the team that conducted the SEA decided they needed the autopsy report in order to move forward with the investigation. VP #4 stated the facility had not received the autopsy report at the point of the survey.

Director #5 stated the SEA included interviewing RN #1, who reported she hung the IV fluid bag to gravity in a pressure bag. Director #5 stated the team that conducted the SEA included a physician, Manager #10, an ED charge nurse, and three to four RNs, including RN #1. Director #5 stated the team had decided hanging an IV fluid bag to gravity in a pressure bag was an acceptable practice. This was in contrast with the facility's educational guidance and from interviews conducted throughout the survey.

i. Review of the Summary of Root Cause Analysis for Patient #2 dated 8/31/22 revealed there were no findings identified during the review which ultimately caused the event outcome. The report documented the autopsy was in progress and the facility was waiting for the final report from the coroner. The report read, the SEA focused on the response to the patient's changing condition and not the cause of death.

l. On 11/21/22 at 10:17 a.m., a second interview with the director of patient safety and risk (Director) #5 was conducted. Director #5 stated three to four days after Patient #2's death, the coroner contacted the facility and told him the patient's family was concerned that something may have happened with the IV infusion because Patient #2 stopped breathing right after the second bag of IV fluids was infused.

Director #5 stated that since it was determined the mechanism of hanging the IV fluids to gravity was deemed acceptable by the team conducting the SEA, there was no further investigation done into the possibility of the IV fluid administration contributing to the patient's death.

Director #5 then stated it was eye opening for him to hear that the interviews conducted throughout the survey consisted of different answers than what was determined from the SEA. He stated if he had gotten the same answers than what was provided in the interviews during the survey, he would have investigated the Patient #2's event as a sentinel event of a medication error.

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

A-0398 - All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). Based on document review and interviews, the facility failed to ensure a standardized process for administering intravenous (IV) fluids was established and adhered to in one of one patients reviewed who died while receiving care in the emergency department (ED).

Based on document review and interviews, the facility failed to ensure a standardized process for administering intravenous (IV) fluids was adhered to in one of one patients reviewed who died while receiving care in the emergency department (ED). (Patient #2) (Cross-reference A-0286)

Findings include:

Facility guidance:

According to an educational slide show titled Presenting Pediatrics provided by the prior ED educator (Educator #9), Intravenous (IV) Administration Guidelines: Age 18 years and younger, all medication fluids must be on a (IV) pump.

1. The facility failed to ensure staff infused IV fluids in accordance with facility guidance and expectations.

a. Review of Patient #2's medical record revealed the patient was 16 months old and presented to the facility on 8/24/22 at 1:37 p.m., with a chief complaint of fever and flu-like symptoms. At 2:14 p.m., the patient's vital signs (temperature, blood pressure, heart rate, and respiration rate) were documented within normal limits. Documentation at this time noted the patient acted age appropriate and the airway was patent.

According to the Emergency Provider Report, the patient was alert, attentive, and the lungs were clear to auscultation (listening to internal sounds of the body). The ED course (treatment plan) included: basic labs, cultures (tests to assess for bacteria or fungi in the body), and two IV fluid boluses (an IV infusion that runs quicker than a standard IV infusion).

The Emergency Provider Report continued with documentation of a reevaluation. According to the reevaluation, the provider was called into the room as the Patient #2 became suddenly lethargic and his lips turned blue. Patient #2's parents reported the patient was eating a cracker and drinking formula when his condition changed. Patient #2's skin became dusky (dark in color) and the heart rate decreased.

According to the Emergency Notes, at 6:15 p.m., the registered nurse (RN) was called to the room by the patient's parents due to increased lethargy. Three RNs responded and the provider was also called to the room. The patient was non responsive to pain stimuli. At 6:24 p.m., the patient was pulseless and apneic (cessation of breathing).

Review of the CPR Record revealed at 6:24 p.m., the patient had no pulse and chest compressions began. At 7:37 p.m., six hours after the patient presented to the ED, the patient was pronounced dead.

b. Review of Patient #2's autopsy report dated 11/11/22 revealed the causative factors of the patient's death included extensive air bubbles throughout the cerebral vasculature (veins located in the brain) and pulmonary edema (excess fluid in the lungs).

c. On 11/17/2022 at 10:47 a.m., an interview with RN #1 was conducted, who stated she began working in the ED in February of 2022. RN #1 stated she did not recall receiving training on administering medications to pediatric patients when she began working in the ED. RN #1 also stated she was trained in the ED to hang IV fluids to gravity when administering them, rather than through an IV pump (medical device that delivers IV fluids to the body in controlled amounts). She said the reason to hang fluids to gravity was to have them infuse quickly.

RN #1 said she recalled providing care to Patient #2 in the ED on 8/24/22. RN #1 stated when she prepared the IV fluid bags for administration, she punctured the insertion site of the IV bag and emptied an amount of fluid so that the remaining fluid in the IV bag matched the amount which was ordered. She stated she could not remember if she used an IV pump or hung the IV fluids to gravity. She stated she could not recall if she had used an IV pressure bag (a bag used to compress an IV bag to allow for the IV fluid to infuse quickly).

After the first bag of IV fluids infused, RN #1 stated she informed the parents that Patient #2 could eat, then she began the administration of the second bag of IV fluid. RN #1 stated a short time later, the patient's mother frantically asked for assistance. RN #1 stated when she entered Patient #2's room, he was unresponsive.

d. On 11/17/22 at 1: 33 p.m., an interview with ED charge nurse (RN #2) was conducted. RN #2 explained the standard process for infusing IV fluids on pediatric patients involved using an IV pump so that the specific volume to be infused could be entered into the pump. RN #2 stated it was not standard practice to manually empty IV fluid from the bag prior to the infusion because there would not be a way of knowing the precise amount of fluid wasted. RN #2 stated it was important to know the specific amount of IV fluid administered because a pediatric patient could become fluid overloaded much quicker than an adult patient, which could result in pulmonary edema, congestive heart failure, and death.

RN #2 stated she recalled assisting with the care of Patient #2 during the code blue event. RN #2 stated she initiated an IV infusion which contained norepinephrine (a medication that treats low blood pressure and heart failure). RN #2 stated she had to leave the patient's room in order to get an IV pump because there was no IV pump in the patient's room.

e. On 11/17/22 at 9:49 a.m., an interview with RN #3 was conducted. RN #3 stated she had been trained to use an IV pump for administering IV fluids to pediatric patients. She stated she would not use a pressure bag to administer IV fluids to pediatric patients because pediatric patients should not receive fluids that fast unless they were undergoing a code blue event. She explained the reason for infusing IV fluids on an IV pump was because pediatric patients had smaller veins that could become infiltrated, and there was a risk of fluid overloading the patient if the fluids were not administered on an IV pump.

f. On 11/17/22 at 3:50 p.m., an interview with Paramedic #6 was conducted. Paramedic #6 explained her role included administering medications, including IV fluids, to patients in the ED on the night shift. Paramedic #6 stated the standard of care was to ensure all IV fluids administered to patients under the age of 13 were infused from an IV pump. Paramedic #6 stated the reason for using an IV pump was to monitor the amount of fluid being infused because pediatric patients were at a higher risk of becoming fluid overloaded. Paramedic #6 stated another reason to use an IV pump was to avoid the risk of the patient receiving an air embolism.

g. On 11/21/22 at 9:39 a.m., an interview was conducted with ED educator (Educator) #8, who stated she began the role of ED educator on 10/31/22, and ED educator (Educator) #9, who stated she was the ED educator in August of 2022. Educator #8 stated hanging IV fluids to gravity for pediatric patient IV fluid administration was not a standard of practice that she would train staff on. She stated she trained staff to use an IV pump or to push fluids manually through a syringe when IV fluids were administered to pediatric patients. Educator #8 stated the reason for using an IV pump or syringe for administering IV fluids to a pediatric patient was to ensure the proper dose was given. Educator #8 further stated using an IV pump or syringe would be a more efficient and faster way to administer IV fluids than hanging IV fluids to gravity.

Educator #9 reiterated the importance of using an IV pump to infuse IV fluids for pediatric patients was to ensure the proper dose was infused and to avoid fluid overloading the patient. Educator #9 stated she had not provided education about reducing the risk of a patient receiving an air embolism after the events surrounding the care of Patient #2.

h. On 11/21/22 at 9:19 a.m., an interview with the ED manager (Manager) #10 was conducted. Manager #10 stated it was acceptable to infuse IV fluids to pediatric patients through an IV pump or by hanging to gravity.

This was in contrast with the facility's guidance and from all other interviews conducted throughout the survey.

She explained usually a pump would be selected because the amount of fluid infusing would be more precise than hanging the IV fluids by gravity. Manager #10 stated the risk of infusing IV fluid too quickly for a pediatric patient included increasing the patient's heart rate.

i. On 11/17/22 at 4:43 p.m., an interview with the vice president of the quality department (VP) #4 and the director of patient safety and risk (Director) #5 were interviewed. VP #4 stated a serious event analysis (SEA) was conducted one week after Patient #2's death.

Director #5 stated the SEA included interviewing RN #1, who reported she hung the IV fluid bag to gravity in a pressure bag. Director #5 stated the team conducting the SEA included a physician, Manager #10, an ED charge nurse, and three to four RNs, including RN #1. Director #5 stated the team had decided hanging an IV fluid bag to gravity in a pressure bag was an acceptable practice. This was in contrast with the facility's educational guidance and from interviews conducted throughout the survey.