HospitalInspections.org

The Condition of Participation for Patient Rights has not been met.

Based on clinical record reviews, observations, review of hospital documentation and interviews for two of six sampled patients (Patient #1 and Patient #2) reviewed for significant medication errors, the hospital failed to ensure care was provided in a safe setting when the patients received Intravenous (IV) fluids and medications that were not in accordance with physician orders resulting in significant harm to one patient and the death of another patient.



Please see A144

Based on clinical record reviews, observations, review of hospital documentation and interviews for two of six sampled patients (Patient #1 and Patient #2) reviewed for significant medication errors, the hospital failed to ensure care was provided in a safe setting when the patients received Intravenous (IV) fluids and medications that were not in accordance with physician orders resulting in significant harm to one patient and the death of another patient. The findings include:


a. Patient #1 was born at 31 3/7 weeks gestation on 8/1/20 at 12:17 PM via cesarean section.

A physician's order dated 8/1/20 directed D10W infusion at 4.1 ml/hr from 1:00 PM to 3:16 PM via peripheral Intravenous (IV).

A physician's order dated 8/1/20 directed to initiate ¼ normal saline with heparin 60 units/60 ml infusion - infuse via Umbilical Vein Catheter (UVC), and D10 with heparin 500 units/500 ml infusion - infuse via Umbilical vein Catheter (UVC).

Review of Patient #1's clinical record dated 8/1/20 identified the patient had an initial glucose level of 53 mg/dl (goal first 24 hours of life is 45-150 mg/dL), was started on IV fluids of 10% glucose (D10W) at 4.1 ml/hr at 1:00 PM and had a repeat blood glucose level of 54 mg/dl at 1:30 PM. An umbilical line was paced, and Patient #1 was started on Total Parenteral Nutrition (TPN) with intralipids (IL) and ¼ NS with heparin. The D10W IV was discontinued at 3:00 PM. Review of the clinical record indicated that at 4:00 PM on 8/1/20 the patient's glucose level was 600 mg/dl and upon assessment, RN #1 noted Patient #1 had inadvertently received approximately 200 ml of D10W. Laboratory results identified a sodium level of 82 mEq/L (goal 134-145 mEq/L) and a glucose level over 1000 mg/dl. The patient was transitioned to 40 cc/kg normal saline at 0.8 ml/hr via each umbilical artery catheter (UAC) and umbilical vein catheter (UVC). The clinical record indicated that Patient #1 experienced intermittent apneic episodes with increased oxygen requirements, was intubated and transferred to a higher level of care with significant hyponatremia and hyperglycemia.

Review of Patient #1's laboratory results identified glucose levels on 8/1/20 at 11:57 PM of over 600 mg/dl, 1,412 mg/dl on 8/2/20 at 1:05 AM, and over 685 mg/dl on 8/2/20 at 1:07 AM. Sodium levels of 82 mEq/L on 8/1/20 at 6:14 PM, 92 mEq/L on 8/1/20 at 9:01 PM and 107 mEq/L on 8/2/20 at 1:05 AM.

The Physician's History and Physical (H&P) note dated 8/1/20 at 3:48 PM indicated Patient #1 was born at 31 3/7 weeks gestation on 8/1/20 at 12:17 PM via Cesarean Section (CS) and was admitted to the neonatal Intensive Care Unit (ICU) because of prematurity. The H&P identified that at the time of delivery, Patient #1 was vigorous and cried spontaneously, the patient's exam was grossly within normal limits, an initial glucose level was 53 mg/dl, and was in no acute distress.

The Neonatal ICU Transfer Summary dated 8/1/20 at 8:22 PM described the significant event of excess fluid bolus administered to Patient #1 via peripheral IV when the team noted the infusion tubing was not clamped off at the time of tube removal from the pump. Approximately 200 ml of D10W was infused. Point of care glucose levels rapidly increased to over 500 mg/dl and laboratory values returned with a sodium level of 82 mEq/L and a glucose level of 1500 mg/dl. The Summary indicated that Patient #1 was intubated, placed on a ventilator, fluids were changed to normal saline and the patient was transferred to a higher level of care.

Review of the ICU admission note dated 8/1/20 at 11:33 PM indicated Patient #1 arrived at 10:37 PM and repeated laboratory blood work identified a sodium level of 106 mEq/L and the glucose level was unmeasurable (over 700 mg/dl). In addition, abnormal movements were noted and suspected to be seizures.

A neurology consult dated 8/2/20 at 12:35 AM indicated that Patient #1's pupils were sluggish but responsive, there was facial grimacing, strong eye closure, some tongue thrusting, and rudimentary sucking movements. The consult also indicated that a head ultrasound showed at least a grade 3 right sided and left sided germinal matrix hemorrhage, and a Magnetic Resonance Image (MRI) showed concern for cerebral edema and clear bilateral intraventricular hemorrhage (IVH). Differential diagnoses included seizures due to hyponatremia, tetany due to hypocalcemia, concern for cerebral edema, and the IVH was worrisome for future cerebral palsy and learning/cognitive deficits.

A review of Patient #1's clinical record (H&P's) dated 8/1 to 8/5/20 indicated nephrology was consulted for severe hyponatremia and free water overload and indicated there was no option for dialysis and recommended to administer 3% saline to correct the seizures and increase sodium. Neurology was consulted and suggested additional imaging to assess for cerebral edema infarction or herniation and indicated that the seizure activities improved with the administration of 3% saline. Pediatric endocrinology and cardiology were also consulted resulting in various treatment recommendations.

Review of a hospital investigation with the hospital's Quality and Safety and Performance Improvement representatives on 9/23/20 at 1:50 PM identified that RN #1 unloaded the D10W IV tubing from the IV pump before disconnecting the IV tubing from the patient, inadvertently unclamped the IV tubing when unloading it from the pump, and did not immediately troubleshoot the cause of Patient #1's hyperglycemia. The hospital investigation identified that there were no mechanisms in place to prevent the uncontrolled flow of IV fluid from the IV to Patient #1.

Interview with RN #1 on 9/23/20 at 2:10 PM indicated that on 8/1/20, Patient #1 was started on dextrose 10% (D10W) via a peripheral intravenous line and an umbilical line was placed. RN #1 indicated that after the umbilical line was placed, she switched from D10W to TPN and intra lipids (IL), turned off the pump with the D10W, applied the clamp, and removed the line from the pump, but left the IV line with the D10 connected to Patient #1. RN #1 stated that after starting Patient #1 on TPN and IL, she noted a blood glucose level of over 500 mg/dl. RN #1 reported the result to PA #1 who ordered to turn off the TPN, increase normal saline and repeat the glucose level in one hour. RN #1 indicated she was told that the high blood sugar may have been due to stress. RN #1 indicated that she realized that Patient #1 had continued to receive the infusion of the D10W fluids, in error, when she saw that the IV bag containing the D10W was low and the clamps on the tubing were opened. RN #1 indicated that she closed the clamps. RN #1 indicated that her practice was to disconnect an IV line after discontinuing fluids but indicated that she did not disconnect Patient #1's IV line on the day of the incident. RN #1 was unable to explain how the IV tubing clamp became unclamped causing an unintended bolus of D10W to Patient #1.

Interview with MD #1 (neonatologist) on 9/24/20 at 11:00 AM indicated he was informed by PA #1 of Patient #1's high glucose level and they started to trouble shoot by discussing the contents of the IV bags and double checking the glucose level. MD #1 indicated that troubleshooting at the bedside revealed that Patient #1 received a bolus of D10W and was hyponatremia and hyperglycemia. MD #1 stated that the plan was to monitor the infant and administer a hypotonic solution of sodium chloride. MD #1 indicated he had never experienced such high glucose levels in a neonate and stated the high levels were the result of volume (IV fluids) and not an issue with the metabolic process.

Interview with PA #1 on 9/24/20 at 11:28 AM indicated that Patient #1 had a peripheral IV with D10W infusing prior to a central line placement. PA #1 indicated that a routine hourly blood glucose level was obtained with a result of "over 500" mg/dl (machine was unable to report results) and a repeat glucose from the central line remained over 500 mg/dl. PA #1 consulted with MD #1 and was told to wait for 1 hour and repeat the blood glucose level. PA #1 indicated after an hour Patient #1's glucose remained high and she again spoke with MD #1, discussed treatments such as starting insulin and the possibility of the hyperglycemia being a stress reaction. PA #1 indicated the decision was to wait another hour. PA #1 indicated that approximately 20 minutes after consulting with MD #1, RN #1 discovered that the IV bag containing D10W was almost empty. At this time PA #1 indicated she contacted MD #1 for advice and spoke with Patient #1's family. PA #1 further indicated that laboratory blood work was obtained and resulted at 1500 mg/dl. The peripheral IV was disconnected and a central line of 1/4 normal saline with heparin was initiated. PA #1 indicated that Patient #1 was edematous, became apneic, was intubated and transferred to a higher level of care. PA #1 stated that after the incident a protocol for handling hyperglycemia was developed.

A review of the manufacturer's directions for unloading the Baxter IV administration sets directed to close the roller clamp to prevent free flow then close the side clamp and push in the keyhole until the door opens. When opening the pump door use only the slide clamp on the tubing loaded into the pump to prevent free flow.

The hospital was unable to provide a policy or procedure that addressed the process and steps used in safely engaging clamps to an IV line, disconnecting the IV line after discontinuing the fluids or on addressing hyperglycemia in the neonatal population.

Following this medication error, the hospital's corrective action included dissemination of a patient safety alert, return demonstration of skills by staff, sharing of the story with all campuses within the organization, and development of a policy addressing hyperglycemia in the neonate.





b). Patient #2 was born at 5:59 PM on 9/11/2020 at 28 5/7 weeks gestation at 970 grams via Cesarean Section secondary to placenta abruption.

The neonatal ICU admission note dated 9/11/20 at 7:42 PM indicated Patient #2 was admitted due to prematurity and respiratory distress. Patient #2 ' s glucose level on admission was 47 mg/dl and was receiving an IV infusion of D10W at 100 mg/kg/day. Patient #2 was receiving Continuous Positive Airway Pressure (CPAP) which required adjustment due to continued grunting during line placement and due to the continued grunting and retractions, Patient #2 was orally intubated, given curosurf, then extubated back to CPAP. The physical exam identified that neurologically Patient #2 was active with normal tone, normal reflexes and symmetrical movements.

A physician's order dated 9/11/20 at 6:38 PM directed IV dextrose 4 ml/hr.

A physician's order dated 9/11/20 at 8:15 PM directed ¼ NS with Heparin 100 units/100 ml 0.8 ml/hr.

Physician's order dated 9/11/20 at 8:55 PM directed D10W with heparin 500 units/500mls 1 ml/hr.

Physician's order dated 9/11/20 at 8:56 PM directed fat emulsion 20% 1g/k/day 0.2 ml/hr and neonatal TPN off hours premixed 2mls/hr.

Review of Patient #2's clinical record dated 9/11/20 indicated the patient was admitted to the NICU, placed on nasal CPAP and a peripheral IV was placed to the left foot. Patient #2's initial glucose level was 47 mg/dl and an IV of D10W was initiated at 4.1mls/hour. A venous/arterial line was placed and at 8:56 PM Patient #2 was started on TPN, intralipids (IL), and D10W with heparin. The D10W via peripheral IV line was discontinued at this time. At 9:15 PM Patient #2 experienced episodes of desaturations (decreased oxygen level) and bradycardia (low heart rate) requiring intubation, caffeine, epinephrine and high frequency ventilator. Patient #2's blood glucose level was noted to be 600 mg/dl and a reconciliation of the IV lines determined that the IV of D10W with heparin was not connected to the IV pump and was free flowing into the patient.

Review of Patient #2's laboratory results indicated glucose levels on 9/11/20 of 47 mg/dl at 6:24 PM, 53 mg/dl at 7:13 PM, 94 mg/dl at 8:34 PM, over 600 mg/dl at 10:13 PM, over 600 mg/dl at 10:19 PM, over 685 mg/dl at 12:00 AM on 9/12/20 and over 1,500 mg/dl at 12:02 AM on 9/12/20.

A review of the H&P note dated 9/12/20 indicated Patient #2 experienced respiratory distress syndrome (RDS), prematurity, and iatrogenic hypernatremia, hypercalcemia and hyperglycemia. A neurologic exam identified Patient #2 was at high risk for cerebral edema given fluid overload and hyponatremia. Further review indicated Patient #2 was on a high frequency oscillator ventilator and was minimally reactive to exam, edematous, twitchy, and shaking.

A nephrology note dated 9/13/20 at 11:43 AM indicated Patient #2 was with acute hyponatremia in the setting of inadvertent D10W with heparin bolus, remained critically ill and glucose levels were correcting. A neurology progress note dated 9/13/20 at 7:30 PM indicated Patient #2 was on continuous Electroencephalogram (EEG) monitoring and was receiving antiepileptics.

A progress note by the Epilepsy Service dated 9/13/20 at 9:33 PM indicated Patient #2 was on continuous EEG monitoring with preliminary report that indicated essentially stable seizure and interictal burden however background remained severely suppressed which indicated severe diffuse or multifocal dysfunction.

Review of the Plan of care overview for Patient #2 dated 9/14/20 at 5:41 PM indicated at 10:40 PM Patient #2 decompensated with oxygen levels in the 40's and did not respond to 100% oxygen, dopamine and epinephrine. A blood transfusion was initiated, the endotracheal tube was suctioned for a moderate amount of frank blood and chest compressions were initiated. The parents were at the bedside, and after discussion, cardiopulmonary resuscitation was stopped so they could hold Patient #2. Patient #2 was pronounced expired at 12:07 AM.

Interview and review of a hospital investigation with the Director of Quality and Safety and Director of Performance Improvement on 9/23/20 at 10:40 AM indicated that a review of the event determined that Patient #2 ' s IV of D10W was inadvertently loaded into the IV pump instead of the D10W with heparin and was connected to Patient #2 without performing line reconciliation. The director noted that D10W with Heparin was left flowing which inadvertently bolused Patient #2 with approximately 200 ml ' s of D10W with Heparin over a period of 1 hour and 15 minutes.

Interview with MD #2 on 9/24/20 at 10:00 AM indicated she was informed that Patient #2 was experiencing acute respiratory decompensation, was intubated, was not maintaining optimal oxygen saturations, and there was blood in the ET tube. MD #2 determined that Patient #2 required increased pressure to improve oxygen saturations, lungs were whited out, the abdomen was distended, and her thought at that time was pulmonary hemorrhage and respiratory distress syndrome. MD #2 indicated that a check of Patient #2's glucose level determined a level of over 600 mg/dl. MD#2 indicated that she saw two IV bags of D10W hanging, one bag with plain D10W and the second with heparin added. MD #2 traced the lines and noted that the IV of D10W with heparin was flowing by gravity into the umbilical line. MD #2 indicated that laboratory blood work identified a sodium level of 81 mEq/L and a glucose level of 1500 mg/dl, and that Patient #2's change in condition was as a result of pulmonary edema from the large fluid volume he/she received. Patient #2 was placed on an oscillator and transferred to a higher level of care.

Interview with RN #2 on 9/24/2020 at 10:30 AM indicated that when she hung Patient #2's IV fluids she inadvertently placed the plain D10W in the IV pump instead of the D10W with heparin. RN #2 stated that Patient #2 developed respiratory distress, was intubated and had a glucose level over 600 mg/dl. RN #2 indicated that the IV lines were traced, and it was determined that the D10W IV with heparin solution was free flowing into Patient #2. RN #2 stated staffing was adequate, Patient #2 was her only patient and she was not distracted on the day of the incident. RN #2 indicated she was trained on running, hanging, and tracing lines during NICU orientation but indicated she did not trace the lines on the day of the incident and stated going forward she would benefit from additional education in line reconciliation.

Interview with RN #3 (Professional Development and educator) on 9/23/20 at 11:41 AM indicated that pumps for infusion of IV fluids were used frequently and staff was trained according to the manufacturers' recommendations on the unit. RN #3 stated that IV tubing used in the NICU have remained the same for the past 2 years. RN #3 indicated IV skills are taught during orientation and at 14 weeks of orientation the nurse was able to care for stable intubated patients with central lines. RN #3 further stated, it was the expectation that after orientation, a staff member was able to prime, clamp, and perform line reconciliation.

Review of the Policy and procedures of 'Nursing Process and Plan of Care (Patient Assessment) indicated reconciliation of lines, drains, and airways is performed by tracing lines, drains and airways from the patient to the point of origin before connecting or reconnecting any device or infusion.

Review of the Peripheral Intravenous (PIV) Catheters Policy and Procedure indicated, for neonate and pediatric patients, infusion pumps are utilized when administering all intravenous non-push medications, blood/blood product transfusion and continuous infusions except when clinically appropriate for patients in the emergency department, pediatric post anesthesia care unit and pediatric intensive care unit.

Following this medication error, the hospital's corrective action included a patient safety alert indicating the importance of tracing all IV lines to the IV bags, removing all discontinued fluids from the work space (list of signed attestation by staff), institution of 2 nurse cross check for the initiation of fluids, and preparation of D10W with heparin in syringes instead of in bags. All nurses in the NICU are required to have second nurse cross check the IV fluid/medication management and line reconciliation with each administration, including the RN involved in this event. If a defect is identified, real time peer coaching will occur and a report to unit leadership is made. Leadership is auditing the practice on a weekly basis to ensure accurate performance.

The Condition of Participation for Nursing Services has not been met.

Based on clinical record reviews, observations, review of hospital documentation and interviews for two of six sampled patients (Patient #1 and Patient #2) reviewed for significant medication errors, the hospital failed to ensure that nursing care was provided in a safe setting when the patients received Intravenous (IV) fluids and medications that were not in accordance with physician orders resulting in significant harm to one patient and the death of another patient.


Please see A405

Based on clinical record reviews, observations, review of hospital documentation and interviews for two of six sampled patients (Patient #1 and Patient #2) reviewed for significant medication errors, the hospital failed to ensure that nursing care was provided in a safe setting when the patients received Intravenous (IV) fluids and medications that were not in accordance with physician orders resulting in significant harm to one patient and the death of another patient. The findings include:


a. Patient #1 was born at 31 3/7 weeks gestation on 8/1/20 at 12:17 PM via cesarean section.

A physician's order dated 8/1/20 directed D10W infusion at 4.1ml/hr from 1:00 PM to 3:16 PM via peripheral Intravenous (IV).

A physician's order dated 8/1/20 directed to initiate ¼ normal saline with heparin 60 units/60 ml infusion - infuse via Umbilical Vein Catheter (UVC), and D10 with heparin 500 units/500 ml infusion - infuse via Umbilical vein Catheter (UVC).

Review of Patient #1's clinical record dated 8/1/20 identified the patient had an initial glucose level of 53md/dl (goal first 24 hours of life is 45-150 mg/dL), was started on IV fluids of 10% glucose (D10W) at 4.1 ml/hr at 1:00 PM and had a repeat blood glucose level of 54 mg/dl at 1:30 PM. An umbilical line was paced, and Patient #1 was started on Total Parenteral Nutrition (TPN) with intralipids (IL) and ¼ NS with heparin. The D10W IV was discontinued at 3:00 PM. Review of the clinical record indicated that at 4:00 PM on 8/1/20 the patient's glucose level was 600 mg/dl and upon assessment, RN #1 noted Patient #1 had inadvertently received approximately 200 ml of D10W. Laboratory results identified a sodium level of 82 mEq/L (goal 134-145 mEq/L) and a glucose level over 1000 mg/dl. The patient was transitioned to 40 cc/kg normal saline at 0.8 ml/hr via each umbilical artery catheter (UAC) and umbilical vein catheter (UVC). The clinical record indicated that Patient #1 experienced intermittent apneic episodes with increased oxygen requirements, was intubated and transferred to a higher level of care with significant hyponatremia and hyperglycemia.

Review of Patient #1's laboratory results identified glucose levels on 8/1/20 at 11:57 PM of over 600 mg/dl, 1,412 mg/dl on 8/2/20 at 1:05 AM, and over 685 mg/dl on 8/2/20 at 1:07 AM. Sodium levels of 82 mEq/L on 8/1/20 at 6:14 PM, 92 mEq/L on 8/1/20 at 9:01 PM and 107 mEq/L on 8/2/20 at 1:05 AM.

The Physician's History and Physical (H&P) note dated 8/1/20 at 3:48 PM indicated Patient #1 was born at 31 3/7 weeks gestation on 8/1/20 at 12:17 PM via Cesarean Section (CS) and was admitted to the neonatal Intensive Care Unit (ICU) because of prematurity. The H&P identified that at the time of delivery, Patient #1 was vigorous and cried spontaneously, the patient's exam was grossly within normal limits, an initial glucose level was 53 mg/dl, and was in no acute distress.

The Neonatal ICU Transfer Summary dated 8/1/20 at 8:22 PM described the significant event of excess fluid bolus administered to Patient #1 via peripheral IV when the team noted the infusion tubing was not clamped off at the time of tube removal from the pump. Approximately 200 ml of D10W was infused. Point of care glucose levels rapidly increased to over 500 mg/dl and laboratory values returned with a sodium level of 82 mEq/L and a glucose level of 1500 mg/dl. The Summary indicated that Patient #1 was intubated, placed on a ventilator, fluids were changed to normal saline and the patient was transferred to a higher level of care.

Review of the ICU admission note dated 8/1/20 at 11:33 PM indicated Patient #1 arrived at 10:37 PM and repeated laboratory blood work identified a sodium level of 106 mEq/L and the glucose level was unmeasurable (over 700 mg/dl). In addition, abnormal movements were noted and suspected to be seizures.

A neurology consult dated 8/2/20 at 12:35 AM indicated that Patient #1's pupils were sluggish but responsive, there was facial grimacing, strong eye closure, some tongue thrusting, and rudimentary sucking movements. The consult also indicated that a head ultrasound showed at least a grade 3 right sided and left sided germinal matrix hemorrhage, and a Magnetic Resonance Image (MRI) showed concern for cerebral edema and clear bilateral intraventricular hemorrhage (IVH). Differential diagnoses included seizures due to hyponatremia, tetany due to hypocalcemia, concern for cerebral edema, and the IVH was worrisome for future cerebral palsy and learning/cognitive deficits.

A review of Patient #1's clinical record (H&P's) dated 8/1 to 8/5/20 indicated nephrology was consulted for severe hyponatremia and free water overload and indicated there was no option for dialysis and recommended to administer 3% saline to correct the seizures and increase sodium. Neurology was consulted and suggested additional imaging to assess for cerebral edema infarction or herniation and indicated that the seizure activities improved with the administration of 3% saline. Pediatric endocrinology and cardiology were also consulted resulting in various treatment recommendations.

Review of a hospital investigation with the hospital's Quality and Safety and Performance Improvement representatives on 9/23/20 at 1:50 PM identified that RN #1 unloaded the D10W IV tubing from the IV pump before disconnecting the IV tubing from the patient, inadvertently unclamped the IV tubing when unloading it from the pump, and did not immediately troubleshoot the cause of Patient #1's hyperglycemia. The hospital investigation identified that there were no mechanisms in place to prevent the uncontrolled flow of IV fluid from the IV to Patient #1.

Interview with RN #1 on 9/23/20 at 2:10 PM indicated that on 8/1/20, Patient #1 was started on dextrose 10% (D10W) via a peripheral intravenous line and an umbilical line was placed. RN #1 indicated that after the umbilical line was placed, she switched from D10W to TPN and intra lipids (IL), turned off the pump with the D10W, applied the clamp, and removed the line from the pump, but left the IV line with the D10 connected to Patient #1. RN #1 stated that after starting Patient #1 on TPN and IL, she noted a blood glucose level of over 500 mg/dl. RN #1 reported the result to PA #1 who ordered to turn off the TPN, increase normal saline and repeat the glucose level in one hour. RN #1 indicated she was told that the high blood sugar may have been due to stress. RN #1 indicated that she realized that Patient #1 had continued to receive the infusion of the D10W fluids, in error, when she saw that the IV bag containing the D10W was low and the clamps on the tubing were opened. RN #1 indicated that she closed the clamps. RN #1 indicated that her practice was to disconnect an IV line after discontinuing fluids but indicated that she did not disconnect Patient #1's IV line on the day of the incident. RN #1 was unable to explain how the IV tubing clamp became unclamped causing an unintended bolus of D10W to Patient #1.

Interview with MD #1 (neonatologist) on 9/24/20 at 11:00 AM indicated he was informed by PA #1 of Patient #1's high glucose level and they started to trouble shoot by discussing the contents of the IV bags and double checking the glucose level. MD #1 indicated that troubleshooting at the bedside revealed that Patient #1 received a bolus of D10W and was hyponatremia and hyperglycemia. MD #1 stated that the plan was to monitor the infant and administer a hypotonic solution of sodium chloride. MD #1 indicated he had never experienced such high glucose levels in a neonate and stated the high levels were the result of volume (IV fluids) and not an issue with the metabolic process.

Interview with PA #1 on 9/24/20 at 11:28 AM indicated that Patient #1 had a peripheral IV with D10W infusing prior to a central line placement. PA #1 indicated that a routine hourly blood glucose level was obtained with a result of "over 500" mg/dl (machine was unable to report results) and a repeat glucose from the central line remained over 500 mg/dl. PA #1 consulted with MD #1 and was told to wait for 1 hour and repeat the blood glucose level. PA #1 indicated after an hour Patient #1's glucose remained high and she again spoke with MD #1, discussed treatments such as starting insulin and the possibility of the hyperglycemia being a stress reaction. PA #1 indicated the decision was to wait another hour. PA #1 indicated that approximately 20 minutes after consulting with MD #1, RN #1 discovered that the IV bag containing D10W was almost empty. At this time PA #1 indicated she contacted MD #1 for advice and spoke with Patient #1's family. PA #1 further indicated that laboratory blood work was obtained and resulted at 1500 mg/dl. The peripheral IV was disconnected and a central line of 1/4 normal saline with heparin was initiated. PA #1 indicated that Patient #1 was edematous, became apneic, was intubated and transferred to a higher level of care. PA #1 stated that after the incident a protocol for handling hyperglycemia was developed.

A review of the manufacturer's directions for unloading the Baxter IV administration sets directed to close the roller clamp to prevent free flow then close the side clamp and push in the keyhole until the door opens. When opening the pump door use only the slide clamp on the tubing loaded into the pump to prevent free flow.

The hospital was unable to provide a policy or procedure that addressed the process and steps used in safely engaging clamps to an IV line, disconnecting the IV line after discontinuing the fluids or on addressing hyperglycemia in the neonatal population.

Following this medication error, the hospital's corrective action included dissemination of a Patient safety alert, return demonstration of skills by staff, sharing of the story with all campuses within the organization, and development of a policy addressing hyperglycemia in the neonate.




b). Patient #2 was born at 5:59 PM on 9/11/2020 at 28 5/7 weeks gestation at 970 grams via Cesarean Section secondary to placenta abruption.

The neonatal ICU admission note dated 9/11/20 at 7:42 PM indicated Patient #2 was admitted due to prematurity and respiratory distress. Patient #2's glucose level on admission was 47 mg/dl and was receiving an IV infusion of D10W at 100 mg/kg/day. Patient #2 was receiving Continuous Positive Airway Pressure (CPAP) which required adjustment due to continued grunting during line placement and due to the continued grunting and retractions, Patient #2 was orally intubated, given curosurf, then extubated back to CPAP. The physical exam identified that neurologically Patient #2 was active with normal tone, normal reflexes and symmetrical movements.

A physician's order dated 9/11/20 at 6:38 PM directed IV dextrose 4 ml/hr.

A physician's order dated 9/11/20 at 8:15 PM directed ¼ NS with Heparin 100 units/100 ml 0.8 ml/hr.

Physician's order dated 9/11/20 at 8:55 PM directed D10W with heparin 500units/500mls 1 ml/hr.

Physician's order dated 9/11/20 at 8:56 PM directed fat emulsion 20% 1g/k/day 0.2 ml/hr and neonatal TPN off hours premixed 2mls/hr.

Review of Patient #2's clinical record dated 9/11/20 indicated the patient was admitted to the NICU, placed on nasal CPAP and a peripheral IV was placed to the left foot. Patient #2's initial glucose level was 47 mg/dl and an IV of D10W was initiated at 4.1mls/hour. A venous/arterial line was placed and at 8:56 PM Patient #2 was started on TPN, intralipids (IL), and D10W with heparin. The D10W via peripheral IV line was discontinued at this time. At 9:15 PM Patient #2 experienced episodes of desaturations (decreased oxygen level) and bradycardia (low heart rate) requiring intubation, caffeine, epinephrine and high frequency ventilator. Patient #2's blood glucose level was noted to be 600 mg/dl and a reconciliation of the IV lines determined that the IV of D10W with heparin was not connected to the IV pump and was free flowing into the patient.

Review of Patient #2's laboratory results indicated glucose levels on 9/11/20 of 47 mg/dl at 6:24 PM, 53 mg/dl at 7:13 PM, 94 mg/dl at 8:34 PM, over 600 mg/dl at 10:13 PM, over 600 mg/dl at 10:19 PM, over 685 mg/dl at 12:00 AM on 9/12/20 and over 1,500 mg/dl at 12:02 AM on 9/12/20.

A review of the H&P note dated 9/12/20 indicated Patient #2 experienced respiratory distress syndrome (RDS), prematurity, and iatrogenic hypernatremia, hypercalcemia and hyperglycemia. A neurologic exam identified Patient #2 was at high risk for cerebral edema given fluid overload and hyponatremia. Further review indicated Patient #2 was on a high frequency oscillator ventilator and was minimally reactive to exam, edematous, twitchy, and shaking.

A nephrology note dated 9/13/20 at 11:43 AM indicated Patient #2 was with acute hyponatremia in the setting of inadvertent D10W with heparin bolus, remained critically ill and glucose levels were correcting. A neurology progress note dated 9/13/20 at 7:30 PM indicated Patient #2 was on continuous Electroencephalogram (EEG) monitoring and was receiving antiepileptics.

A progress note by the Epilepsy Service dated 9/13/20 at 9:33 PM indicated Patient #2 was on continuous EEG monitoring with preliminary report that indicated essentially stable seizure and interictal burden however background remained severely suppressed which indicated severe diffuse or multifocal dysfunction.

Review of the Plan of care overview for Patient #2 dated 9/14/20 at 5:41 PM indicated at 10:40 PM Patient #2 decompensated with oxygen levels in the 40's and did not respond to 100% oxygen, dopamine and epinephrine. A blood transfusion was initiated, the endotracheal tube was suctioned for a moderate amount of frank blood and chest compressions were initiated. The parents were at the bedside, and after discussion, cardiopulmonary resuscitation was stopped so they could hold Patient #2. Patient #2 was pronounced expired at 12:07 AM.

Interview and review of a hospital investigation with the Director of Quality and Safety and Director of Performance Improvement on 9/23/20 at 10:40 AM indicated that a review of the event determined that Patient #2's IV of D10W was inadvertently loaded into the IV pump instead of the D10W with heparin and was connected to Patient #2 without performing line reconciliation. The director noted that D10W with Heparin was left flowing which inadvertently bolused Patient #2 with approximately 200 ml ' s of D10W with Heparin over a period of 1 hour and 15 minutes.

Interview with MD #2 on 9/24/20 at 10:00 AM indicated she was informed that Patient #2 was experiencing acute respiratory decompensation, was intubated, was not maintaining optimal oxygen saturations, and there was blood in the ET tube. MD #2 determined that Patient #2 required increased pressure to improve oxygen saturations, lungs were whited out, the abdomen was distended, and her thought at that time was pulmonary hemorrhage and respiratory distress syndrome. MD #2 indicated that a check of Patient #2's glucose level determined a level of over 600 mg/dl. MD#2 indicated that she saw two IV bags of D10W hanging, one bag with plain D10W and the second with heparin added. MD #2 traced the lines and noted that the IV of D10W with heparin was flowing by gravity into the umbilical line. MD #2 indicated that laboratory blood work identified a sodium level of 81 mEq/L and a glucose level of 1500 mg/dl, and that Patient #2's change in condition was as a result of pulmonary edema from the large fluid volume he/she received. Patient #2 was placed on an oscillator and transferred to a higher level of care.

Interview with RN #2 on 9/24/2020 at 10:30 AM indicated that when she hung Patient #2's IV fluids she inadvertently placed the plain D10W in the IV pump instead of the D10W with heparin. RN #2 stated that Patient #2 developed respiratory distress, was intubated and had a glucose level over 600 mg/dl. RN #2 indicated that the IV lines were traced, and it was determined that the D10W IV with heparin solution was free flowing into Patient #2. RN #2 stated staffing was adequate, Patient #2 was her only patient and she was not distracted on the day of the incident. RN #2 indicated she was trained on running, hanging, and tracing lines during NICU orientation but indicated she did not trace the lines on the day of the incident and stated going forward she would benefit from additional education in line reconciliation.

Interview with RN #3 (Professional Development and educator) on 9/23/20 at 11:41 AM indicated that pumps for infusion of IV fluids were used frequently and staff was trained according to the manufacturers' recommendations on the unit. RN #3 stated that IV tubing used in the NICU have remained the same for the past 2 years. RN #3 indicated IV skills are taught during orientation and at 14 weeks of orientation the nurse was able to care for stable intubated patients with central lines. RN #3 further stated, it was the expectation that after orientation, a staff member was able to prime, clamp, and perform line reconciliation.

Review of the Policy and procedures of Nursing Process and Plan of Care (Patient Assessment) indicated reconciliation of lines, drains, and airways is performed by tracing lines, drains and airways from the patient to the point of origin before connecting or reconnecting any device or infusion.

Review of the Peripheral Intravenous (PIV) Catheters Policy and Procedure indicated, for neonate and pediatric patients, infusion pumps are utilized when administering all intravenous non-push medications, blood/blood product transfusion and continuous infusions except when clinically appropriate for patients in the emergency department, pediatric post anesthesia care unit and pediatric intensive care unit.

Following this medication error, the hospital's corrective action included a patient safety alert indicating the importance of tracing all IV lines to the IV bags, removing all discontinued fluids from the work space (list of signed attestation by staff), institution of 2 nurse cross check for the initiation of fluids, and preparation of D10W with heparin in syringes instead of in bags. All nurses in the NICU are required to have second nurse cross check the IV fluid/medication management and line reconciliation with each administration, including the RN involved in this event. If a defect is identified, real time peer coaching will occur and a report to unit leadership is made. Leadership is auditing the practice on a weekly basis to ensure accurate performance.