HospitalInspections.org

Based on observation, interview, review of the ED record of 1 of 1 Patient who received an IV paralytic medication in error (Patient 1), review of hospital policies and procedures, and review of other documentation, it was determined the hospital failed to ensure the patient's right to receive care in a safe setting. The hospital failed to ensure IV medication was correctly and appropriately prepared, labeled, and verified prior to being dispensed from the pharmacy and administered to Patient 1; and the hospital failed to ensure the RN supervised, monitored and evaluated Patient 1's condition after administering IV medications, including monitoring the patient's cardiac status and pulse oximetry, in accordance with physician orders, hospital policy, and professional medication references.

This Condition-level deficiency substantially limited the hospital's capacity to furnish care in a safe setting.

Findings include:

1. Refer to the findings identified under Tag A490, 42 CFR 482.25, the Condition of Participation for Pharmaceutical Services. That deficiency reflects the hospital's failure to ensure medication was appropriately prepared, labeled, and verified prior to being dispensed from the pharmacy and administered to Patient 1 in accordance with hospital policies and procedures.

2. Refer to the findings identified under Tag A385, 42 CFR 482.23, the Condition of Participation for Nursing Services. That deficiency reflects the hospital's failure to ensure the RN monitored and evaluated Patient 1's condition after administering IV medications to the patient, including monitoring the patient's cardiac status and pulse oximetry, in accordance with physician orders, hospital policies and procedures, and professional medication references.

29708

Based on observation, interview, review of the ED record of 1 of 1 Patient who received an IV paralytic medication in error (Patient 1), and review of hospital policies and procedures, it was determined the hospital failed to ensure the RN supervised, monitored and evaluated Patient 1's condition, including monitoring the patient's cardiac status and pulse oximetry, in accordance with physician orders, hospital policy, and professional medication references.

This Condition-level deficiency substantially limited the hospital's capacity to furnish care in a safe setting.

Findings include:

1. The ED record of Patient 1 was reviewed. The triage report electronically signed by the RN and dated 12/01/2014 at 1139 reflected that the patient presented to the ED on 12/01/2014 at 1133. The patient's chief complaint was recorded as "Confusion: recent brain surgery." The patient's vital signs at 1139 were recorded as blood pressure 146/92, temperature 36.6 C, pulse 77, and respirations 15. The patient's pulse oximetry was recorded as 97 percent on room air.

Additional vital signs were assessed by the RN at 1353 and 1440.

The record reflected that an order for continuous pulse oximetry monitoring was written by the physician on 12/01/2014 at 1236. The record reflected RN "Acknowledgement" of the order on 12/01/2014 at 1317, 41 minutes after the order was written. The "Vital Sign Report" reflected that pulse oximetry was assessed on 12/01/2014 at 1353 as 99 percent, and on 12/01/2014 at 1440 as 93 percent.

The record also reflected that an order for continuous cardiac monitoring was written by the physician on 12/01/2014 at 1236. The record reflected RN "Acknowledgement" of the order on 12/01/2014 at 1317, 41 minutes after the order was written. However, there was no documentation in the record that the RN implemented the continuous cardiac monitoring in accordance with the physician order.

The MAR reflected Lorazepam IV PRN, ordered by the physician, was administered by the RN on 12/01/2014 at 1307 and again at 1505.

In addition, the MAR reflected fosphenytoin IV, ordered by the physician, was administered by the RN on 12/01/2014 at 1520.

Also at 1520, the RN documented on the "Daily Focus Assessment Report" the following: "...Up to BR w/ minimal assist. Talkative, seems oriented, other than alittle (sic) forgetful. Steady on [his/her] feet."

The next documentation by the RN at 1602, 42 minutes later, reflected "...Pt found unresponsive, no pulse palpable, code Blue called."

Although two different IV medications were administered to Patient 1 within 15 minutes of each other on 12/01/2014 at 1505 and 1520, there was no evidence in the record to reflect that the RN observed and monitored the patient's condition and responses to those medications. There was no evidence that vital signs or pulse oximetry had been obtained between 1440 and 1602, when the patient was found unresponsive, and the continuous cardiac monitoring ordered by the physician at 1236 had not been implemented.

A consultation report dictated by a physician on 12/02/2014 at 0045 reflected the following: "...500 mg IV fosphenytoin was ordered. [Patient] did not complete the infusion as [patient] had cardiopulmonary arrest before it was completed. This was unwitnessed with report of anywhere from 10-20 minutes unobserved before [patient] was found obtunded with no pulse or respirations...Additional details were obtained from the nurse that took care of the patient in the ER. [He/she] reports that there was a change of shift around 1505, and patient was given 1 mg [Lorazepam]. [Patient] was awake and talkative around 1530 just prior to start of fosphenytoin infusion, and was accompanied by the nurse to the bathroom across the ER and back. [Patient] returned to bed, and the infusion was started around 1535...[Patient] was not on monitoring at the time. After about 25 minutes, the nurse went in and found [patient] obtunded, cyanotic, pulseless and not breathing and called a CODE..."

The physician discharge summary dictated by a physician on 12/03/2014 at 1243 reflected the following: "While in the emergency room...[Patient] was administered medication which inadvertently was rocuronium...The patient suffered cardiac and pulmonary arrest and was resuscitated. [Patient] was admitted to the ICU...[On 12/03/2014]...At approximately 10:10 the patient was taken off of mechanical ventilation and switched to comfort care. Approximately 55 minutes later, the patient expired."

2. Information about the anti-convulsant IV fosphenytoin which the RN documented as having administered, was reviewed on the Drugs.com website and dated 12/05/2014. It reflected the following: "WARNING...Careful cardiac monitoring is needed during and after administering intravenous Fosphenytoin sodium. Although the risk of cardiac toxicity increases with infusion rates above the recommended infusion rate, these events have also been reported at or below the recommended infusion rate. Reduction in rate of administration or discontinuation of dosing may be needed..."

In addition, the "Nursing 2013 Drug Handbook" reflected that for fosphenytoin IV the RN was to "Monitor patient's [heart rate and rhythm], blood pressure, and respirations continuously during maximum phenytoin level - about 10 to 20 minutes after end of fosphenytoin infusion. Severe [cardiovascular] complications are most common in elderly or gravely ill patients. If needed, decrease rate or stop infusion."

3. The hospital's policy and procedure titled "SCHS Medication, Administration, and Documentation" dated as effective 08/08/2014 was reviewed. The "Administration" section of the policy reflected the following requirements: "...The patient's response to any medication, and particularly one that is being given for the first time, is monitored by nursing staff for therapeutic or adverse effects. This monitoring includes, but is not limited to: Vital signs, lab values, blood levels, therapeutic ranges, and the patient's perceptions. Documentation of patient's response to all PRN medications is required."

4. A tour of the ED was conducted with the CNO on 01/14/2015 at 1720. Observations from the nurse's station, referred to by staff as "Pod 1," revealed that the room where Patient 1 was treated was directly across the hall.

5. An interview was conducted with the CNO on 01/16/2015 at 1010. He/she confirmed that the physician ordered continuous cardiac monitoring and continuous pulse oximetry monitoring for Patient 1. During the interview, the CNO acknowledged that although the RN initiated pulse oximetry, he/she discontinued it without an order to do so. He/she further confirmed that the RN never initiated continuous cardiac monitoring at all. In addition, the CNO acknowledged that if the patient had been on cardiac monitoring as ordered, an audible alarm would have sounded and alerted staff at the nurse's station when the patient's cardiac status declined.

Based on interview and review of documentation in 1 of 6 newborn medical records (Patient 12), it was determined that the hospital failed to ensure that a bilirubin laboratory report was maintained in the medical record to ensure that health care staff involved in care could access/retrieve the information in order to monitor the patient's condition and provide appropriate care.

Findings include:

1. The medical record for Patient 12 was reviewed with the Clinical Risk Coordinator present. The "Nursing Assessment Flowsheet" reflected that Patient 12 was born on 06/26/2013 at 0926.

A nursing progress note dated 06/27/2013 at 0515, recorded by an RN on the "Nursing Assessment Flowsheet", reflected that "PKU, bili...done in patient room."

A physician progress note dated as dictated on 6/27/2013 at 1052, reflected under "Laboratory Data" that the newborn had a "Total bilirubin 7.5 at 19 hours: High risk."

The medical record for Patient 12 included toxicology, cord blood ABO, Coombs, and PKU laboratory test reports. However, there was no evidence in the laboratory section, or elsewhere in the medical record, of a bilirubin laboratory report. There was no documentation in the medical record to explain the lack of a laboratory report when the RN had documented that he/she had obtained a blood sample for a bilirubin test. Nor was there laboratory documentation to support the bilirubin test result the physician referred to in his/her note.

The Clinical Risk Coordinator and Quality Management staff were interviewed on 01/15/2015 at approximately 1500 and confirmed the lack of a bilirubin laboratory report.

29708

Based on interview, review of the ED record of 1 of 1 Patient who received an IV paralytic medication in error (Patient 1), and review of hospital policies and procedures, it was determined the hospital failed to ensure a physician ordered medication was correctly and appropriately prepared, labeled and verified prior to being dispensed from the pharmacy and administered to Patient 1 in accordance with hospital policies and procedures.

This Condition-level deficiency substantially limited the hospital's capacity to furnish care in a safe setting.

Findings included:

1. The ED record of Patient 1 was reviewed. The triage report electronically signed by the RN and dated 12/01/2014 at 1139 reflected that the patient presented to the ED on 12/01/2014 at 1133. The patient's chief complaint was recorded as "Confusion: recent brain surgery."

The MAR reflected a physician order for administration of fosphenytoin IV dated 12/01/2014 at 1449. The MAR reflected the medication was administered by the RN on 12/01/2014 at 1520.

A history and physical report dictated by a physician on 12/01/2014 at 1802 reflected the following: "...[Patient] was given 0.5 gram of phenytoin (sic) and was going to be discharged according to the nurse that was caring for the patient. There was approximately a 20 minute interval when the patient was in the room by [himself/herself]...the patient was found apneic and blue as well as pulseless...A code blue was called..."

A progress note dictated by a physician on 12/02/2014 at 1412 reflected "After reviewing the events of the patient's arrest in the emergency room, it has become apparent the patient was given rocuronium instead of fosphenytoin in a bag which was miss-labelled (sic) and this is the cause of the patient's cardiac arrest..."

The discharge summary dictated by a physician on 12/03/2014 at 1243 reflected the patient's final diagnoses were as follows: Severe anoxic encephalopathy, myoclonic status epilepticus, cardiac arrest, and inadvertent administration of rocuronium.

Patient 1's ED record contained no physician's order for IV rocuronium, a paralytic medication.

2. Information about the paralytic IV rocuronium on the "Drugs.com" website dated 12/05/2014 was reviewed. It reflected the following: "Rocuronium is indicated as an adjunct to general anesthesia to facilitate rapid-sequence or routine tracheal intubation and to induce skeletal muscle relaxation during surgery or mechanical ventilation."

Information about the paralytic IV rocuronium on the "MPR" (Monthly Prescribing Reference) website dated 02/04/2015 was reviewed. It reflected the following: "Warnings/Precautions: To be administered under the supervision of experienced clinicians. Have intubation, artificial respiration, oxygen therapy and reversal agents available. Must be accompanied by adequate anesthesia or sedation. To prevent residual paralysis, should extubate only after neuromuscular block recovery."

The "Nursing 2013 Drug Handbook" does not contain information about rocuronium.

3. The hospital's policy and procedure titled "Staging for Sterile Compounding" dated "11/25/14" was reviewed. The policy required the following: "The pharmacist must inspect the finished prescription for correctness, clarity, package integrity, beyond use date, label the container(s), and initial the label."

4. An interview was conducted with the Pharmacy Operations Manager on 01/15/2015 at 1240. The manager stated that on 12/01/2014 at approximately 1450, the pharmacy department received a physician order for IV fosphenytoin for Patient 1. He/she stated that a pharmacy tech compounded IV rocuronium in error and placed the physician ordered fosphenytoin label on the IV medication bag that contained the rocuronium. The pharmacy tech gave the compounded medication to the pharmacist for verification. The pharmacist checked the compounded medication, initialed the label on the IV medication bag, and released the mis-labeled medication from the pharmacy to the ED for administration to Patient 1. The manager further stated "It was an incorrectly compounded medication. It set the nurse up for failure."

During the interview, the manager confirmed that pharmacy staff failed to follow pharmacy protocols for verification of medication orders and for checks of medication prior to release from the pharmacy. He/she acknowledged that as a result of these failures, rocuronium was incorrectly prepared, labeled, verified, and dispensed from the pharmacy for administration to Patient 1, in place of the ordered fosphenytoin.