HospitalInspections.org

Based on staff interview and record review the Condition of Participation: Patient Rights was not met as evidenced by the hospital's failure to ensure the provision of patient care was safely provided during an emergency procedure conducted in the Medical Intensive Care Unit for 1 applicable patient.

Refer to Tag: A - 0144 & 286

Based on staff interview and record review the hospital failed to ensure the provision of patient care was safely provided during an emergency procedure conducted in the Medical Intensive Care Unit for 1 applicable patient. (Patient #1) Findings include:

Per record review, Patient #1 sought treatment in the Emergency Department (ED) on 1/27/15 after experiencing 3 days of shortness of breath with constriction when breathing and complaining of not being able to catch a good breath, especially if attempting to ambulate. At the time of admission to the ED Patient #1, age 55, was hypotensive (low blood pressure) and required the assistance of BiPAP (Biphasic positive airway pressure) machine to assist with breathing. A portable chest x-ray taken at 1:03 PM confirmed Patient #1 was experiencing pulmonary edema and possible pneumonia and the patient was administered a diuretic to treat fluid retention and antibiotics for pneumonia. At 3:11 PM, Patient #1 was evaluated by Critical Care physicians and it was determined the patient required admission.

Per Progress Note, Patient #1 was transferred from the ED to the Medical Intensive Care Unit (MICU) at 4:20 PM. During the process of transferring the patient from the ED stretcher to the MICU bed, Patient #1 became obtunded (altered level of consciousness) and was in respiratory distress. Critical Care physicians rapidly responded and it was determined at approximately 4:25 PM Patient #1 required intubation for mechanical ventilation as a result of respiratory distress/compromise. Nursing staff obtained and brought to the patient's room the Rapid Sequence Intubation (RSI) medication box. Meanwhile Respiratory Therapists and physicians prepared intubation instruments and endotracheal tube for the RSI (a standard of care in emergency airway management for intubations not anticipated to be difficult when medications are administered simultaneously to render a patient unconscious to facilitate endotracheal intubation).

For the emergent intubation, the physician directed via verbal orders specific medications to be prepared by nursing which included Rocuronium 100mg (a neuromuscular blocker which provides skeletal muscle relaxation). The physician also ordered Ketamine100 mg (an anesthetic agent used for sedation/analgesic effect with a time to effect of 45 seconds to 60 seconds and duration of 10-20 minutes for correct dosing of 1 to 2 mg/kg). Both medications were ordered to be administered IV (Intravenously). Nurse #1, assigned to Patient #1 at the time of admission to MICU, documented s/he administered Rocuronium 100 mg at 4:46 PM followed by Ketamine. Although the physician had ordered Ketamine 100 mg. amounting to 1 cc of medication, Nurse #1 drew up the total amount of the multidose vial of 5cc/500 mg of Ketamine and subsequently at 4:46 PM administered the entire contents of the syringe totaling 500 mg to Patient #1. Per "Adult Resuscitation Record", at 4:53 PM Patient #1 was in cardiac arrest with Pulseless Electrical Activity (PEA) and chest compressions were started. Per Progress Note, Nurse #1 documents: "At approx 1650 - 1655 (4:50 - 4:55 PM), realization of overdose of ketamine realized and MD XXXX notified as well as charge nurse". Patient #1 received additional cardiac drugs, however resuscitation efforts were unsuccessful, the Code procedure efforts were ended and the patient was pronounced dead at 5:16 PM.

The attending physician's Progress Note for 1/27/15 at 21:15 states: "I was notified by his/her bedside nurse that the patient was mistakenly given a significantly larger dose of his/her induction agent of ketamine than I had ordered. I stated that Ketamine is ideally the agent we use for patients with cardiogenic shock or hemodynamic instability as it has the least effects on his/her hemodynamics and least likely to cause low blood pressure; however, I stated that this dose was higher than I had ordered and was concerned that it may have contributed to his/her poor outcome.....I could not be certain whether it caused his/her cardiac arrest, but I did note that it may not have helped."

Per interview on 3/17/15 at 9:30 AM, Nurse #1 confirmed that on 1/27/15 at the time of the RSI s/he had thought Patient #1 may require increasing doses of Ketamine to achieve the desired effect and therefore drew up more of the drug in the syringe in anticipation that the physician would order more to be administered during the procedure. However, Nurse #1 stated "In the moment, I thought I only had 100 mg. in the syringe". Nurse #1 stated the practice of drawing more medication than ordered by the physician was something s/he has done throughout his/her nursing practice while working in Critical Care.

The nursing practice of drawing up more medication then what was ordered was further confirmed by the Nurse Manager of MICU on 3/17/15 at 9:45 AM noting, a lot of nursing staff probably draw up more medication than what the physician has ordered, especially during an emergent patient situation. Per interview on 3/17/15 at 11:22 AM, MICU Nurse #2 stated when a physician gives a verbal order for a medication during an intubation or cardiac arrest, s/he would repeat the order back to the physician for confirmation. After preparing the medication a label is applied to the syringe which would state the drug, the amount drawn up in a syringe and the concentration of the drug. Nurse #2 also confirmed, at times, s/he would draw up extra medication then what was ordered. The ED Nurse Manager stated, during interview at 3:38 PM on 3/17/15, that although his/her practice, during RSI, was to draw up just the amount of medication ordered by the physician, there might be times when s/he would draw up more medication in the syringe in anticipation that they physician might order sequential doses.

Per interview on 3/17/15 at 2:05 PM, the Vice President (VP) of Nursing stated s/he was aware of the situation regarding the overdose of Ketamine by Nurse #1 in the MICU and had reviewed the Root Cause Analysis but presently had not provided any direction regarding the case. The VP of Nursing also stated the practice related to medications is "... you draw up what the order is and that is what is expected..." of nurses.

In addition, although a Root Cause Analysis (RCA) was developed on 1/29/15 and 3 action plans were formulated to improve patient safety and nursing practice, as of 3/17/15 none of the plans had been initiated. It was not until an Immediate Jeopardy was determined to exist on 3/18/15 the hospital took immediate corrective action to ensure patient safety by replacing Ketamine 500 mg multidose vials with 200 mg. vials in all RCI medication kits; Nursing Services received direction regarding drawing up only the dose ordered by providers and a review of "read back" process was reinforced.

Refer to Tags: A -0286; 0405 & 500

The Condition of Participation: Quality Assurance and Performance Improvement (QA/PI) was not met as evidenced by the failure of the hospital to implement an effective hospital-wide action plan after a significant adverse patient event had occurred.

Refer to Tag - A- 0286, 0405 & 500

Based on staff interview and record review there was a failure of Quality Assurance/Performance Improvement to effectively evaluate, fully analyze and fully implement immediate actions when a significant adverse patient event occurred. (Patient #1) Findings include:

On 1/27/15 Patient #1 was transferred from the ED to the Medical Intensive Care Unit (MICU) at 4:20 PM. During the process of transferring the patient from the ED stretcher to the MICU bed, Patient #1 became obtunded (altered level of consciousness) and in respiratory distress. Critical Care physicians rapidly responded and it was determined at approximately 4:25 PM Patient #1 required intubation for mechanical ventilation as a result of respiratory distress/compromise. Nursing staff obtained and brought to the patient's room the Rapid Sequence Intubation (RSI) medication box. Meanwhile Respiratory Therapists and physicians prepared intubation instruments and endotracheal tube for the RSI to secure an airway for Patient #1.

For the emergent intubation the physician directed via verbal orders specific medications to be prepared by nursing which included Rocuronium 100mg (a neuromuscular blocker which provides skeletal muscle relaxation). The physician also ordered Ketamine100 mg (an anesthetic agent used for sedation/analgesic effect with a time to effect of 45 seconds to 60 seconds and duration of 10-20 minutes for correct dosing of 1 to 2 mg/kg) Both medications were ordered to be administered IV (Intravenously). Nurse #1, assigned to Patient #1 at the time of admission to MICU, documented s/he administered Rocuronium 100 mg at 4:46 PM followed by Ketamine. Although the physician had ordered Ketamine 100 mg. amounting to 1 cc of medication, Nurse #1 drew up the total amount of the multidose vial of 5cc/500 mg of Ketamine and subsequently at 4:46 PM administered the entire contents of the syringe totaling 500 mg to Patient #1. Per "Adult Resuscitation Record", at 4:53 PM Patient #1 was in cardiac arrest with Pulseless Electrical Activity (PEA) and chest compressions were started. Per Progress Note, Nurse #1 documents: "At approx 1650 - 1655 (4:50 - 4:55 PM), realization of overdose of ketamine realized and MD XXXX notified as well as charge nurse". Patient #1 received additional cardiac drugs, however resuscitation efforts were unsuccessful, the Code procedure efforts were ended and the patient was pronounced dead at 5:16 PM.

The attending physician's Progress Note for 1/27/15 at 21:15 states: "I was notified by his/her bedside nurse that the patient was mistakenly given a significantly larger dose of his/her induction agent of Ketamine than I had ordered. I stated that Ketamine is ideally the agent we use for patients with cardiogenic shock or hemodynamic instability as it has the least effects on his/her hemodynamics and least likely to cause low blood pressure; however, I stated that this dose was higher than I had ordered and was concerned that it may have contributed to his/her poor outcome.....I could not be certain whether it caused his/her cardiac arrest, but I did note that it may not have helped." Shortly after the incident a "Safe Report" was filed (Adverse Event Report) and on 1/29/15 a Root Cause Analysis (RCA) was conducted which included staff involved in the event on 1/27/15 along with the Director for Critical Care, Medication Safety Coordinator, Director of Critical Care Nursing and a QA/PI consultant.

Per interview on 3/16/15 at 12:50 PM, the Director of Patient Safety and Advocacy stated issues identified during the RCA included the size and concentration of the multidose vial of Ketamine used by Nurse #1. An action plan included the Resuscitation Committee which included pharmacy would evaluate alternative concentrations of Ketamine such as 100 mg or 200 mg vials and standardize the dose vial throughout the hospital. This would provide a safety barrier in preventing to larger of a dose of Ketamine being drawn and administered during a RCI noting Nurse #1 had drawn and administered a dose greater then what was prescribed. The Director confirmed, although it had been 49 days since the death of Patient #1, changes had not been made to remove the 500 mg. multidose vials of Ketamine from the RCI medication boxes, in exchange for a reduced concentration. The Director stated one reason preventing the change was due to a Ketamine drug shortage and Anesthesia still needed to be consulted regarding the specific concentrations they require.

A second action plan was to developed policy practice guidelines for administering medications noting that Nurse #1 had drawn up a larger dose of Ketamine, deviating from the physician order. Per interview with Nurse #1 on 3/17/15 at 9:30 AM, Nurse #1 confirmed that on 1/27/15 at the time of the RSI s/he had anticipated Patient #1 would require more Ketamine due to the patient's weight so s/he decided to draw up more then what the physician had ordered. However, Nurse #1 stated "In the moment, I thought I only had 100 mg. in the syringe". Nurse #1 stated the practice of drawing more medication then ordered by the physician was something s/he has done throughout his/her nursing practice while working in Critical Care. Deviating form the physician's order during an emergent procedure was confirmed by the Nurse Manager of MICU on 1/17/15 at 9:45 AM as still presently going on with some nurses practicing in MICU.

A third action plan was reinforcing the "closed loop communication" process between physicians and the nurse during emergent procedures. The Director of Patient Safety and Quality confirmed Nurse #1 did repeat back to the physician what the verbal order was (Ketamine 100 mg) and acknowledged 100 mg. of Ketamine was being administered, however Nurse #1 pushed intravenously 500 mg.

When determining what had been enacted upon of the 3 areas identified from the RCA, it was confirmed multidose vials of Ketamine 100 mg/5cc still remained in all of the RCI medication boxes throughout the hospital. Per interview on 3/19/15 at 12:15 PM the Pharmacy Manager for Clinical Practice confirmed there was a drug shortage of Ketamine in December of 2009 and was resolved in 2010. The Manager further confirmed if asked in January 2015 to make a change in Ketamine vial concentrations, various drug concentrations were and still are available. Further confirming Anesthesia Services already has the Pharmacy department providing predawn syringes of Ketamine for specific needs within Anesthesia services.

A hospital wide education of nurses reinforcing standards of nursing practice regarding following physician orders and not drawing up more medication then what was ordered had not been addressed. Although the MICU Nursing Council meeting on 2/20/15 discussed the event of 1/27/15 there was a failure to implement a hospital wide directive to nurses regarding drawing up only what the physician has ordered. In addition, it was further confirmed by the Nurse Manager of MICU on 3/17/15 at 9:45 the nursing practice of drawing up more medication then what was ordered during an emergent procedure was probably still being performed by some nurses in MICU.

In regards to the "close loop communication", the Medical Director of Adult Critical Care Services confirmed on 3/18/15 at 10:15 AM although s/he has brought the incident to the attention of physicians practicing in MICU, reminding them to continue close communication practice with nurses involved during emergent procedures, s/he failed to share the incident and concerns with Surgical Intensive Care Unit (ICU) or to other directors who provide supervision where Ketamine may be used during RCI.

It was not until an Immediate Jeopardy situation was determined to exist, when the hospital made the necessary changes to assure care was provided in a safe setting. The mutidose vials of 500 mg of Ketamine were exchanged for 200 mg vials in all RCI medication boxes. Under the Direction of the VP of Nursing Services the standard of practice related to the administration of medications from a vial or ampule was reviewed and an educational module was developed and deployed throughout all nursing services. In addition, the module reinforced the practice of drawing up only the dose ordered, and the expectation that the "read back" will occur when preparing medications in the presence of and under the direction of the provider.

Based on staff interview and record review, the Condition of Participation: Nursing Services was not met based on hospital nursing staff's failure to follow physician orders for the administration of an intravenous medication and administering a dose greater then what was ordered.


Refer to TAG: A- 0405

Based on staff interview and record review, a Registered Nurse (RN) failed to prepare and administer a medication in accordance with the orders of the practitioner responsible for the patient's care and in accordance with hospital policy and standards of nursing practice for 1 of 10 applicable patients. (Patient #1) Findings include:

Per record review, Patient #1 sought treatment in the Emergency Department (ED) on 1/27/15 after experiencing 3 days of shortness of breath with constriction when breathing and complaining of not being able to catch a good breath, especially if attempting to ambulate. At the time of admission to the ED Patient #1, age 55, was hypotensive (low blood pressure) and required the assistance of BiPAP (Biphasic positive airway pressure) machine to assist with breathing. A portable chest x-ray taken at 1:03 PM confirmed Patient #1 was experiencing pulmonary edema and possible pneumonia and the patient was administered a diuretic to treat fluid retention and antibiotics for pneumonia. At 3:11 PM, Patient #1 was evaluated by Critical Care physicians and it was determined the patient required admission.

Per Progress Note, Patient #1 was transferred from the ED to the Medical Intensive Care Unit (MICU) at 4:20 PM. During the process of transferring the patient from the ED stretcher to the MICU bed, Patient #1 became obtunded (altered level of consciousness) and was in respiratory distress. Critical Care physicians rapidly responded and it was determined at approximately 4:25 PM Patient #1 required intubation for mechanical ventilation as a result of respiratory distress/compromise. Nursing staff obtained and brought to the patient's room the Rapid Sequence Intubation (RSI) medication box. Meanwhile Respiratory Therapists and physicians prepared intubation instruments and endotracheal tube for the RSI.

For the emergent intubation, the physician directed via verbal orders specific medications to be prepared by nursing which included Rocuronium 100mg (a neuromuscular blocker which provides skeletal muscle relaxation). The physician also ordered Ketamine100 mg (an anesthetic agent used for sedation/analgesic effect with a time to effect of 45 seconds to 60 seconds and duration of 10-20 minutes for correct dosing of 1 to 2 mg/kg) Both medications were ordered to be administered IV (Intravenously). Nurse #1, assigned to Patient #1 at the time of admission to MICU, documented s/he administered Rocuronium 100 mg at 4:46 PM followed by Ketamine. Although the physician had ordered Ketamine 100 mg. amounting to 1 cc of medication, Nurse #1 drew up the total amount of the multidose vial of 5cc/500 mg of Ketamine and subsequently at 4:46 PM administered the entire contents of the syringe totaling 500 mg to Patient #1. Per "Adult Resuscitation Record", at 4:53 PM Patient #1 was in cardiac arrest with Pulseless Electrical Activity (PEA) and chest compressions were started. Per Progress Note, Nurse #1 documents: "At approx 1650 - 1655 (4:50 - 4:55 PM), realization of overdose of ketamine realized and MD XXXX notified as well as charge nurse". Patient #1 received additional cardiac drugs, however resuscitation efforts were unsuccessful, the Code procedure efforts were ended and the patient was pronounced dead at 5:16 PM.

The attending physician's Progress Note for 1/27/15 at 21:15 states: "I was notified by his/her bedside nurse that the patient was mistakenly given a significantly larger dose of his/her induction agent of ketamine than I had ordered. I stated that Ketamine is ideally the agent we use for patients with cardiogenic shock or hemodynamic instability as it has the least effects on his/her hemodynamics and least likely to cause low blood pressure; however, I stated that this dose was higher than I had ordered and was concerned that it may have contributed to his/her poor outcome.....I could not be certain whether it caused his/her cardiac arrest, but I did note that it may not have helped."

Per interview on 3/17/15 at 9:30 AM, Nurse #1 confirmed that on 1/27/15 at the time of the RSI s/he had thought Patient #1 may require increasing doses of Ketamine to achieve the desired effect and therefore drew up more of the drug in the syringe in anticipation that the physician would order more to be administerd during the procedure. However, Nurse #1 stated "In the moment, I thought I only had 100 mg. in the syringe". Nurse #1 stated the practice of drawing more medication than ordered by the physician was something s/he has done throughout his/her nursing practice while working in Critical Care.

The nursing practice of drawing up more medication then what was ordered was further confirmed by the Nurse Manager of MICU on 3/17/15 at 9:45 AM noting, a lot of nursing staff probably draw up more medication than what the physician has ordered, especially during an emergent patient situation. Per interview on 3/17/15 at 11:22 AM, MICU Nurse #2 stated when a physician gives a verbal order for a medication during an intubation or cardiac arrest, s/he would repeat the order back to the physician for confirmation. After preparing the medication a label is applied to the syringe which would state the drug, the amount drawn up in a syringe and the concentration of the drug. Nurse #2 also confirmed, at times, s/he would draw up extra medication then what was ordered. The ED Nurse Manager stated, during interview at 3:38 PM on 3/17/15, that although his/her practice, during RSI, was to draw up just the amount of medication ordered by the physician, there might be times when s/he would draw up more medication in the syringe in anticipation that they physician might order sequential doses. However, per interview on 3/18/15 at 10:15 AM the Medical Director of Adult Critical Care Services acknowledged the drawing up of more medication by nurses then what the physician has ordered during an emergency procedure creates "...a potential for error".

Per interview on 3/17/15 at 2:05 PM, the Vice President (VP) of Nursing stated s/he was aware of the situation regarding the overdose of Ketamine by Nurse #1 in the MICU and had reviewed the Root Cause Analysis but presently had not provided any direction regarding the case. The VP of Nursing also stated the practice related to medications is "... you draw up what the order is and that is what is expected..." of nurses.

Per hospital policy Intravenous Medications; Preparation and Administration of : by RNs and LPNs published on 7/29/14 states " 3. A RN will administer medications via IV push as ordered by a physician and dispensed by the pharmacy."

The Condition of Particpaton: Pharmacy Services was not met due to the failure of Pharmacy Services to act in a timely manner to ensure patient safety by replacing high dose vials of Ketamine within all applicable and high risk areas throughout the hospital.


Refer to Tag A - 0500

Based on observations, interview and record review the Pharmacy Services failed to act in a timely manner to ensure patient safety by replacing high dose vials of Ketamine within all applicable and high risk areas throughout the hospital. (Patient #1) Findings include:

During an emergent intubation of a patient in MICU on 1/27/15 the physician directed via verbal orders specific medications to be prepared by nursing which included Rocuronium 100mg (a neuromuscular blocker which provides skeletal muscle relaxation). The physician also ordered Ketamine100 mg (an anesthetic agent used for sedation/analgesic effect with a time to effect of 45 seconds to 60 seconds and duration of 10-20 minutes for correct dosing of 1 to 2 mg/kg) Both medications were ordered to be administered IV (Intravenously). Nurse #1, assigned to Patient #1 at the time of admission to MICU, documented s/he administered Rocuronium 100 mg at 4:46 PM followed by Ketamine. Although the physician had ordered Ketamine 100 mg. amounting to 1 cc of medication, Nurse #1 drew up the total amount of the multidose vial of 5cc/500 mg of Ketamine and subsequently at 4:46 PM administered the entire contents of the syringe totaling 500 mg to Patient #1. Per "Adult Resuscitation Record", at 4:53 PM Patient #1 was in cardiac arrest with Pulseless Electrical Activity (PEA) and chest compressions were started. Per Progress Note, Nurse #1 documents: "At approx 1650 - 1655 (4:50 - 4:55 PM), realization of overdose of ketamine realized and MD XXXX notified as well as charge nurse". Patient #1 received additional cardiac drugs, however resuscitation efforts were unsuccessful, the Code procedure efforts were ended and the patient was pronounced dead at 5:16 PM.

Per interview on 3/16/15 at 12:50 PM, the Director of Patient Safety and Advocacy stated issues identified during the RCA included the size and concentration of the multidose vial of Ketamine used by Nurse #1. An action plan included the Resuscitation Committee which included pharmacy would evaluate alternative concentrations of Ketamine such as 100 mg or 200 mg vials and standardize the dose vial throughout the hospital. This would provide a safety barrier in preventing a larger dose of Ketamine being drawn and administered during a RCI, noting Nurse #1 had drawn and administered a dose greater then what was prescribed. The Director confirmed, although it had been 49 days since the death of Patient #1, changes had not been made to remove the 500 mg. multidose vials of Ketamine from the RCI medication boxes, in exchange for a reduced concentration. The Director stated one reason preventing the change was due to a Ketamine drug shortage and Anesthesia still needed to be consulted regarding the specific concentrations they require. Per observation in MICU on 3/17/15 at 8:40 AM, the RCI medication boxes still contained Ketamine 100 mg/5 cc multidose vials.

Per interview on 3/16/15 at 4:10 PM a pharmacist who is the medication safety coordinator confirmed s/he was involved with the RCA and was working on a action plan to replace the multidose vials of 500 mg of Ketamine. "We are pretty close to the result of having a 10 mg/ml vial and 20 cc vial (200 mg)" and further noting the ICUs never use more than 200 mg of Ketamine during an event. The pharmacist also acknowledged a shortage of Ketamine and that further discussions with Anesthesia Services was needed prior to making any changes in Ketamine concentration. The pharmacist further acknowledged proper medication administration is looking at the vial and making sure you have the right dose.

Per interview on 3/17/15 at 1:00 PM, the Chief of Anesthesiology acknowledged Anesthesia Services has 2 concentrations of Ketamine, 10 mg/1 cc and 100 mg/1 cc available for the provision of patient care. The Chief of Anesthesiology stated several years ago his/her service requested pharmacy to provide pre-drawn syringes of Ketamine, very low doses of Ketamine 0.1 and 0.2 mg/kg used as an adjunct to reduce opioid dosing. Anesthesia Services does have access to Ketamine 100 mg/1 cc in Pyxis (automated medication station) but there are alerts to assure the right dose is being used.

Per interview on 3/19/15 at 12:15 PM the Pharmacy Manager for Clinical Practice confirmed there was a drug shortage of Ketamine in December of 2009 and was resolved in 2010. The Manager further confirmed if asked in January 2015 to make a change in Ketamine vial concentrations, various drug concentrations were and still are available. Further confirming Anesthesia Services already has the Pharmacy department providing predawn syringes of Ketamine for specific needs within Anesthesia services. On 3/19/15 12:10 PM, the Pharmacy Manager for Clinical Practice confirmed Ketamine 500 mg mutidose vials had been removed from all the RCI boxes and replaced with 200 mg Ketamine vials.