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SHARP MEMORIAL HOSPITAL 7901 FROST ST SAN DIEGO, CA 92123 June 20, 2013
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0208
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the professional nursing staff in the neo natal intensive care unit (NICU) consisting of RN P and RN D, failed to accurately assess an intravenous infusion. RN P and RN D did not implement nursing practice of manually tracing intravenous lines from source to to the patient. This resulted in a medication error in which the infusion of excess intravenous solution caused 1 of 48 sampled patients, Baby 1 to have critically high blood sugar levels, seizures, swelling and bleeding into the brain.

Findings:

Aspects of this report will predate the Complaint Validation Survey authorized by CMS date 6/18/13. The initial investigation was authorized under the State of California Licensing and Certification Division, Entity Reported Incident CA 312 starting 2/8/13.

On 1/22/13, the hospital's administration reported to the California Department of Public Health (CDPH) an incident related to the care and treatment of premature infant Baby 1. As reported by the hospital's administrative representative, on 1/17/13 an error related to the infusion of an intravenous nutritional solution occurred.

Per the physician progress dated 1/14/13 notes, Baby 1 was born at the facility on 1/14/13 prematurely and weighing 4.1 pounds. The physician identified Baby 1's needs at birth to include treatment for [DIAGNOSES REDACTED] (low blood sugar), respiratory distress. The neurologic assessment was documented as "appropriate for gestational age."

The physician's orders included the infusion of nutritional solutions (Total Nutritional Additives = TNA) via a catheter inserted in the umbilical vein. The review of the TNA labeling from 1/16/13 and 1/17/13, indicated a mixture of various electrolytes and minerals which were in a 10% percent dextrose solution to supplement Baby 1's nutritional needs and mitigate the hypoglycemic issues.

On 1/17/13 at 8:28 P.M., Physician R documented in Baby 1's medical record "I was notified that this infant was suspected have received and excessive amount of TPN, (TNA) was suspected to have severe hyperglycemia [high blood sugar], was exhibiting polyuria [excessive urine] and was pale and poorly perfused."

Physician R's assessment of Baby 1 provided the following, " The infant appeared hypovolemic [abnormally low volume of blood circulating through the body], was tachycardic [abnormally rapid heart rate], and had poor perfusion."

Physician R's ongoing assessment and documentation dated 1/17/13 at 11 P.M., described Baby 1 as "tremulous ... possibility of neonatal seizures." On 1/18/13 at 3 A.M., Physician R described Baby 1 as "appeared to show EEG evidence of seizure activity. The EEG events were associated with episodes of neonatal apnea [absence of breathing]. The infant was endotracheally intubated [breathing tube is placed into the windpipe through the mouth or the nose] and placed on mechanical ventilation. The infant has been loaded with Phenobarbital [anticonvulsant] then with Levetiracetam [used to help control certain types of seizures] due to persistent seizures."

Baby 1 had ultra sound done on 1/18/13, and revealed enlargement of the brain and bleeding into the brain. The ultra sound report indicated "worsening" of the bleeding in the brain and "post hemorrhagic [DIAGNOSES REDACTED]." [A buildup of fluid inside the skull that leads to brain swelling]

The above represented a significant change in the condition of Baby 1 and was not present at birth on 1/14/13.

Baby 1 was transferred to a pediatric hospital on [DATE] for further evaluation and treatment. The medical records from the pediatric hospital provided a drain was surgically placed into the brain of Baby 1 on 2/5/13 to aid in the displacement of fluid buildup. On 3/5/13, the physician concluded the following for Baby 1 in the discharge summary:

1. The ongoing use of anticonvulsant medications.
2. Follow-up care with a neurosurgeon related to the need for post- operative care of [DIAGNOSES REDACTED].

RN P was not interviewed due to the hospital's action of terminating the employ of RN P on 1/24/13, prior to the arrival of CDPH.

RN D was responsible for the care and treatment of Baby 1 beginning 1/17/13 at 7 P.M., and was interviewed on 3/1/13 at 7:45 A.M., related to the events on 1/17/13.

RN D stated she relieved RN P at approximately 7 P.M. on 1/17/13, and collaborated with RN P at the bedside of Baby 1. The exchange of information included the specific care needs of Baby 1, i.e., confirming physician orders of TNA intravenous fluids, infusion pumps are correctly labeled, and the intravenous lines (IV) were to be traced manually from point of source to site of infusion.

RN D stated upon assuming care of Baby 1 on 1/17/13 at approximately 7 P.M., she did not attend to the process of manually tracing of the IV lines from the source to input, but limited the process to a "visual" tracing only.

RN D stated at approximately 7:40 P.M., she checked the blood sugar level of Baby 1 using a hand held bedside device, and the device could not measure the blood sugar level because of a "high value" message alert. Another check of the blood sugar was done with the same results. RN D stated she alerted Nurse Practitioner M about the condition of Baby 1, and was directed to send a blood sample to the laboratory to confirm the blood sugar level of Baby 1.

Baby 1 was discovered to have blood sugar in excess of 1500 mg. Normal values for blood glucose range from 70 to 120 mg.

RN D stated during the initial assessment she failed to initiate the manual tracing of the intravenous line connections. RN D later discovered TNA bag #2, started by RN P on 1/17/13 at approximately 5:30 P.M., had tubing inserted into the infusion pump, but was not connected to Baby 1's intravenous port. The contents of the TNA bag # 2 bag were found to be dripping on the floor. RN D stated she found TNA bag #1 was not connected to any infusion pump, and had infused infusing into Baby 1 unregulated.

The NICU nurse manager was interviewed on 3/20/13 at 12:30 P.M., and stated the hospital's investigation related to the incident revealed TNA bag #1 was empty, and Baby 1 received approximately 60 cc's in excess solution as a result of the error.

The administration of the TNA solution to Baby 1 on 1/17/13 was not consistent with the hospital policy/procedure for Medication/Administration (# .99) related to "Right dose." The excess of 60 cc's TNA solution constituted the medication error.

The NICU nurse manager was re-interviewed on 6/20/13 at 8:20 A.M. related to the hospital's investigation of the incident. The infusion pumps were discovered to have a fail safe device (clamp) to stop any infusion of fluids when removed from the infusion pump. In order to override (open) the fail safe device it was necessary to manually open the clamp. The NICU nurse manager was asked if RN P offered any explanations related to how the fail safe device was overridden The NICU nurse manager stated RN P had no recall of what had happened after the intravenous TNA solution had been primed for administration. During the course of the needed interventions for Baby 1, the equipment related to the incident was not retained for further examination.

RN P was not interviewed due to the hospital's action of terminating the employ of RN P on 1/24/13, prior to the arrival of CDPH.