HospitalInspections.org

The Condition of Participation for Medical Staff has not been met as evidenced by:

Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for 1 (Patient #5) of 10 patients with medication orders, the hospital failed to ensure that the "Hard to Enter Medication" order was authenticated by an authorized prescriber (AP) and failed to ensure that a complete intravenous (IV) "Hard to Enter Medication" was able to be entered into the electronic order entry system by the ordering practitioner to ensure that the patient received the intended medication at the intended dose. Patient #5 did not receive the intended dose of Amiodarone and as a result, was over medicated and expired.

Please refer to A347

Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for 1 (Patient #5) of 10 patients with medication orders, the hospital failed to ensure that the "Hard to Enter Medication" order was authenticated by an authorized prescriber (AP) and failed to ensure that a complete intravenous (IV) "Hard to Enter Medication" was able to be entered into the electronic order entry system by the ordering practitioner to ensure that the patient received the intended medication at the intended dose. Patient #5 did not receive the intended dose of Amiodarone and as a result, was over medicated and expired. The findings include:

Patient #5 was admitted to the hospital's Neonatal Intensive Care Unit (NICU) on 7/8/15 from another acute care hospital where the patient was delivered on 7/7/15 at 5:23 AM and had failed the Critical Congenital Heart Defect (CCHD) screen. Patient #5's diagnoses included transposition of the aorta (TGA), large ventricular septal defect (VSD), atrial septal defect (ASD), straddling mitral valve, mitral regurgitation, s/p atrial septostomy (7/18/15) and supraventricular tachycardia (SVT). Review of the clinical record identified that Patient #5 was receiving oral Propranolol and IV Adenosine for SVT treatment.
Review of the clinical record and interview with the Pediatric Cardiology Fellow, MD #9 on 8/11/15 at 12:00 PM identified that on the evening of 7/20/15, Patient #5 had an increase in the frequency of breakthrough SVT and required an IV Amiodarone loading dose. MD #9 indicated that in consultation with the Pediatric Cardiologist, MD #10, the decision was made to give a small IV loading dose of Amiodarone 2.5 mg/kg to be administered over 60 minutes.
Interview with PA #1 on 8/12/15 at 1:00 PM identified that per direction from MD #9, PA #1 ordered the Amiodarone IV through the hospital's CPOE system. Review of the medication orders entered by PA #1 indicated that the first IV Amiodarone order (197168815) was entered at 11:15 PM on 7/20/15 that directed IV bolus 8.98 mg, route: IV, frequency: bolus from syringe over 5 minutes. PA #1 indicated that he/she did not enter the bolus from syringe over 5 minutes in the original order. Interview with the Manager of Medication Safety on 8/12/15 at 1:45 PM identified that the frequency of the medication may have been a "default" entry auto-populated by the computer system.
MD #9 identified that he/she was called on 7/21/15 at 1:14 AM by PA #1, who reported that approximately half-way through the Amiodarone IV infusion, Patient #5 became severely bradycardic, apneic, with desaturation to the 30's and the Amiodarone infusion was stopped. Patient #5 was resuscitated for 2 hours, resuscitation efforts were unsuccessful and Patient #5 was pronounced expired on 7/21/15 at 3:14 AM. MD #9 identified that in consultation with pharmacy staff, it was identified that there had been an accidental misdosing (compounding error) of the Amiodarone.
Review of the clinical record and interview with PA #1 on 8/12/15 at 1:00 PM identified that Patient #5 weighed 3.59 kg and based on calculation, should have received a total of 8.98 mg of IV Amiodarone, but received approximately 75 mg in error.
Interview with Pharmacist #1 on 8/18/15 at 2:00 PM and 8/20/15 at 2:00 PM indicated that Patient #5's first Amiodarone order directed bolus from syringe in the CPOE system of the computerized medical record system EPIC. However, Pharmacist #1 identified that Patient #5 did not have an IV drip hanging for the bolus and the order did not have a rate and diluent ordered.
Pharmacist #1 identified that EPIC did not have (pediatric/newborn) Amiodarone IV available in the database selection in the order set. Pharmacist #1 communicated to PA #1 that he/she would have to manipulate the Amiodarone order in order to enter it into EPIC. According to policy, a Pharmacist is able to take a verbal order from an Authorized Prescriber (AP).
Pharmacist #1 attempted to customize the Amiodarone order, reentered it numerous times, and ultimately entered it as a "Hard to Enter Medication" on 7/20/15. The second IV Amiodarone order (197168821) was entered at 11:40 PM by Pharmacist #1 as "Hard to Enter Medication" that directed dose: 1 each, route: other, frequency: once and administering instructions: Amiodarone 8.98 mg/D5W 8.98 ml to infuse over 5 minutes as bolus. This order was discontinued by Pharmacist #1 at 11:50 PM.
The third IV Amiodarone order (197168822) entered at 11:50 PM by Pharmacist #1 directed 8.98 mg in dextrose 5% (DEHP-FREE) 100 ml (1mg/ml) peripheral line IV infusion (newborn), frequency: continuous over 1 hour. On interview, Pharmacist #1 identified that the IV Amiodarone order could not be entered correctly into the CPOE EPIC database system because the computerized medication system identified that the infusion rate was too high.
Pharmacist #1 entered the fourth Amiodarone order at 11:52 PM as "Hard to Enter Medication" (197168823), dose: 1 each, route: other. The order included instructions: Amiodarone 8.98 mg/D5W 8.98 ml, infuse over 1 hour. Pharmacist #1 identified that this order was finally accepted by the computer into DoseEdge (Pharmacy computerized IV compounding system) from EPIC.
Pharmacist #1 indicated that "Hard to Enter" orders were considered verbal orders. Review of the Orders for Patient Care or Research Policy identified in part, in all instances of verbal orders, the order was written down by Hospital staff authorized to accept and record verbal orders, read back to the prescriber and then entered as verbal orders in the clinical information system. Such orders were validated by an Authorized Prescriber (AP) with the next use of CPOE. Verbal orders shall meet all requirements of a Valid Order .... To be valid, an order must contain enough information for the staff to understand what was requested ...and must contain the name of the desired drug, the dose to be administered, the route and the frequency. Also, the policy indicated that no other caregiver has the authority, except under power of an approved protocol, to discontinue an active AP order.
Review of the clinical record identified that each of the Amiodarone orders dated 7/20/15: #197168821, #197168822 and #197168823 with the mode: "Ordering in Verbal with readback: cosign required," had not been electronically signed/authenticated by PA #1 until 8/4/15. Review of the Medication Management Policy identified that dating, timing and authenticating of standing orders and protocols by the ordering practitioner or another practitioner responsible for the patient's care was completed in accordance with professional standards of practice; law and regulation; hospital policies; and medical staff bylaws, rules and regulations.
Although the hospital failed to have a policy to address the process of entering "Hard to Enter" medications at the time of the event, review of the policy (dated July 31, 2015) Compounding IV Sterile Products Outside of DoseEdge: "Hard to Enter" IV Medication Orders identified that for an order to pass accurately into DoseEdge, the order screen must be built properly in EPIC to send all components into DoseEdge through an interface. "Hard to Enter" EPIC orders were considered compounding OUTSIDE of DoseEdge.
Review of Patient #5's clinical record, review of the "All Orders" printout dated 8/10/15 and interviews with hospital personnel failed to reflect that a complete and authenticated IV Amiodarone medication order was written/entered/maintained in the patient record. Amiodarone orders generated on 7/20/15 were not authenticated by PA #1 until 8/4/15 despite PA #1 accessing Patient #5's clinical record on 7/21/15 at 4:23 PM to document a discharge summary.
Patient #5's death certificate identified the cause of death as asystole due to complete cardiac heart block.

The Condition of Participation for Medical Record Services has not been met as evidenced by:

1. Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for 1 (Patient #5) of 10 patients with medication orders, the hospital failed to ensure that the "Hard to Enter Medication" order was authenticated by an authorized prescriber (AP) and failed to ensure that a complete intravenous (IV) "Hard to Enter Medication" was able to be entered into the electronic order entry system by the ordering practitioner to ensure that the patient received the intended medication at the intended dose. Patient #5 did not receive the intended dose of Amiodarone and as a result, was over medicated and expired.

2. Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for one (Patient #6) of 10 patients who underwent surgery, the hospital failed to ensure that the anesthesia intraprocedure grid/graph documentation provided essential details of patient monitoring when the patient's vital signs became unstable and/or failed to ensure that therapeutic measures of CPR were accurately documented and/or that the ambulatory surgical OR and anesthesia service had a policy or process in place to adequately document CPR measures.


Please refer to A467

1. Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for 1 (Patient #5) of 10 patients with medication orders, the hospital failed to ensure that a "Hard to Enter Medication" order was authenticated by an authorized prescriber (AP) and failed to ensure that a complete intravenous (IV) "Hard to Enter Medication" was able to be entered into the electronic order entry system by the ordering practitioner to ensure that the patient received the intended medication at the intended dose. Patient #5 did not receive the intended dose of Amiodarone and as a result, was over medicated and expired. The findings include:

Patient #5 was admitted to the hospital's Neonatal Intensive Care Unit (NICU) on 7/8/15 from another acute care hospital where the patient was delivered on 7/7/15 at 5:23 AM and had failed the Critical Congenital Heart Defect (CCHD) screen. Patient #5's diagnoses included transposition of the aorta (TGA), large ventricular septal defect (VSD), atrial septal defect (ASD), straddling mitral valve, mitral regurgitation, s/p atrial septostomy (7/18/15) and supraventricular tachycardia (SVT). Review of the clinical record identified that Patient #5 was receiving oral Propranolol and IV Adenosine for SVT treatment.
Review of the clinical record and interview with the Pediatric Cardiology Fellow, MD #9 on 8/11/15 at 12:00 PM identified that on the evening of 7/20/15, Patient #5 had an increase in the frequency of breakthrough SVT and required an IV Amiodarone loading dose. MD #9 indicated that in consultation with the Pediatric Cardiologist, MD #10, the decision was made to give a small IV loading dose of Amiodarone 2.5 mg/kg to be administered over 60 minutes.
Interview with PA #1 on 8/12/15 at 1:00 PM identified that per direction from MD #9, PA #1 ordered the Amiodarone IV through the hospital's CPOE system. Review of the medication orders entered by PA #1 indicated that the first IV Amiodarone order (197168815) was entered at 11:15 PM on 7/20/15 that directed IV bolus 8.98 mg, route: IV, frequency: bolus from syringe over 5 minutes. PA #1 indicated that he/she did not enter the bolus from syringe over 5 minutes in the original order. Interview with the Manager of Medication Safety on 8/12/15 at 1:45 PM identified that the frequency of the medication may have been a "default" entry auto-populated by the computer system.
MD #9 identified that he/she was called on 7/21/15 at 1:14 AM by PA #1, who reported that approximately half-way through the Amiodarone IV infusion, Patient #5 became severely bradycardic, apneic, with desaturation to the 30's and the Amiodarone infusion was stopped. Patient #5 was resuscitated for 2 hours, resuscitation efforts were unsuccessful and Patient #5 was pronounced expired on 7/21/15 at 3:14 AM. MD #9 identified that in consultation with pharmacy staff, it was identified that there had been an accidental misdosing (compounding error) of the Amiodarone.
Review of the clinical record and interview with PA #1 on 8/12/15 at 1:00 PM identified that Patient #5 weighed 3.59 kg and based on calculation, should have received a total of 8.98 mg of IV Amiodarone, but received approximately 75 mg in error.
Interview with Pharmacist #1 on 8/18/15 at 2:00 PM and 8/20/15 at 2:00 PM indicated that Patient #5's first Amiodarone order directed bolus from syringe in the CPOE system of the computerized medical record system EPIC. However, Pharmacist #1 identified that Patient #5 did not have an IV drip hanging for the bolus and the order did not have a rate and diluent ordered.
Pharmacist #1 identified that EPIC did not have (pediatric/newborn) Amiodarone IV available in the database selection in the order set. Pharmacist #1 communicated to PA #1 that he/she would have to manipulate the Amiodarone order in order to enter it into EPIC. According to policy, a Pharmacist is able to take a verbal order from an Authorized Prescriber (AP).
Pharmacist #1 attempted to customize the Amiodarone order, reentered it numerous times, and ultimately entered it as a "Hard to Enter Medication" on 7/20/15. The second IV Amiodarone order (197168821) was entered at 11:40 PM by Pharmacist #1 as "Hard to Enter Medication" that directed dose: 1 each, route: other, frequency: once and administering instructions: Amiodarone 8.98 mg/D5W 8.98 ml to infuse over 5 minutes as bolus. This order was discontinued by Pharmacist #1 at 11:50 PM.
The third IV Amiodarone order (197168822) entered at 11:50 PM by Pharmacist #1 directed 8.98 mg in dextrose 5% (DEHP-FREE) 100 ml (1mg/ml) peripheral line IV infusion (newborn), frequency: continuous over 1 hour. On interview, Pharmacist #1 identified that the IV Amiodarone order could not be entered correctly into the CPOE EPIC database system because the computerized medication system identified that the infusion rate was too high.
Pharmacist #1 entered the fourth Amiodarone order at 11:52 PM as "Hard to Enter Medication" (197168823), dose: 1 each, route: other. The order included instructions: Amiodarone 8.98 mg/D5W 8.98 ml, infuse over 1 hour. Pharmacist #1 identified that this order was finally accepted by the computer into DoseEdge (Pharmacy computerized IV compounding system) from EPIC.
Pharmacist #1 indicated that "Hard to Enter" orders were considered verbal orders. Review of the Orders for Patient Care or Research Policy identified in part, in all instances of verbal orders, the order was written down by Hospital staff authorized to accept and record verbal orders, read back to the prescriber and then entered as verbal orders in the clinical information system. Such orders were validated by an Authorized Prescriber (AP) with the next use of CPOE. Verbal orders shall meet all requirements of a Valid Order .... To be valid, an order must contain enough information for the staff to understand what was requested ...and must contain the name of the desired drug, the dose to be administered, the route and the frequency. Also, the policy indicated that no other caregiver has the authority, except under power of an approved protocol, to discontinue an active AP order.
Review of the clinical record identified that each of the Amiodarone orders dated 7/20/15: #197168821, #197168822 and #197168823 with the mode: "Ordering in Verbal with readback: cosign required," had not been electronically signed/authenticated by PA #1 until 8/4/15. Review of the Medication Management Policy identified that dating, timing and authenticating of standing orders and protocols by the ordering practitioner or another practitioner responsible for the patient's care was completed in accordance with professional standards of practice; law and regulation; hospital policies; and medical staff bylaws, rules and regulations.
Although the hospital failed to have a policy to address the process of entering "Hard to Enter" medications at the time of the event, review of the policy (dated July 31, 2015) Compounding IV Sterile Products Outside of DoseEdge: "Hard to Enter" IV Medication Orders identified that for an order to pass accurately into DoseEdge, the order screen must be built properly in EPIC to send all components into DoseEdge through an interface. "Hard to Enter" EPIC orders were considered compounding OUTSIDE of DoseEdge.
Review of Patient #5's clinical record, review of the "All Orders" printout dated 8/10/15 and interviews with hospital personnel failed to reflect that a complete and authenticated IV Amiodarone medication order was written/entered/maintained in the patient record. Amiodarone orders generated on 7/20/15 were not authenticated by PA #1 until 8/4/15 despite PA #1 accessing Patient #5's clinical record on 7/21/15 at 4:23 PM to document a discharge summary.
Patient #5's death certificate identified the cause of death as asystole due to complete cardiac heart block.
__________________


2. Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for one (Patient #6) of 10 patients who underwent surgery, the hospital failed to ensure that the anesthesia intraprocedure grid/graph documentation provided essential details of patient monitoring when the patient's vital signs became unstable and/or failed to ensure that therapeutic measures of CPR were accurately documented and/or that the ambulatory surgical OR and anesthesia service had a policy or process in place to adequately document CPR measures. The findings include:

Patient #6 was admitted to the hospital's ambulatory surgical OR on 1/6/15 at 6:14 AM for a right pars plana vitrectomy, endolaser and right scleral buckle. Review of the clinical record identified that the patient's past medical history included pneumothorax and dislocated shoulder; home medications included Lamictal and Depakote. Review of the anesthesia record and interview with the anesthesiologist, MD #14 on 9/9/15 at 9:20 AM identified that MD #14 completed the pre-procedure anesthesia evaluation and informed consent was verbally obtained. The primary anesthesia plan was ASA 2 and MAC. Anesthesia started at 7:40 AM and the procedure start time was 7:59 AM. Review of the anesthesia intraprocedure grid/graph dated 1/6/15 and interview with MD #14 identified that the patient's baseline heart rate was low 50's and RR was 12 (normal 12-20) with 2 liters of oxygen (O2) via nasal cannula (NC).

Review of the clinical record and interview with MD #14 on 9/9/15 at 9:20 AM identified that during the surgery Patient #6 became bradycardic twice (11:14 AM and 11:16 AM) due to eye manipulation (oculocardiac reflex). MD #14 could not recall what the patient's heart rate (HR) and/or the rhythm were at that time. MD #14 administered Atropine IV and indicated that Patient #6 did not respond to the Atropine administered at 11:16 AM. Patient #6 experienced a cardio/pulmonary arrest in the OR at 11:17 AM and cardiopulmonary resuscitation (CPR) was performed. The anesthesia report identified Patient #6 received a total of the following IV medications during the surgery (prior to the arrest): Versed 4 mg; Alfentanil 1000 mcg; Propofol 482.6 mg and Fentanyl 100 mcg. Patient #6 did not receive any reversal agents.

The anesthesia report identified Patient #6 received a total of the following IV medications during the surgery (prior to the arrest): Versed 4 mg; Alfentanil 1000 mcg; Propofol 482.6 mg and Fentanyl 100 mcg. Although some of the medications were documented on the intraprocedure grid/graph, the graph failed to reflect the IV Propofol 10mg/ml drip (mcg/kg/min), as well as the IV Propofol bolus 30 mg at 11:07 AM administered prior to the arrest. The IV Propofol drip was temporarily stopped then resumed at 11:02 AM, starting at a rate of 100 mcg/kg/min and then decreased to 50 mcg/kg/min at 11:08 AM and stopped at 11:14 AM.

Upon surveyor inquiry, MD #14 did not recall if the patient was breathing at 11:14 AM. However, the record indicated that the patient's RR was 0 from 11:12 AM - 11:16 AM with an oxygen saturation (SpO2) of 82-88% on 2L of O2 via NC. The oxygen was increased to 4L O2 via NC at 11:14 AM and the IV Propofol drip was discontinued. The record also identified that Patient #6's HR increased from the 50's to the 80's during that time. Patient #6's last blood pressure obtained was recorded at 11:09 AM, 110/70.

MD #14 identified that Patient #6 did not have a radial or carotid pulse at 11:17 AM. SpO2 was 48% and the O2 was increased to 10L. MD #14 called "anesthesia stat" and compressions were started at 11:18 AM. The record failed to reflect who performed compressions, how long the compressions were continued and/or if the compressions were effective. Although, MD #14 identified that initially he/she directed the code and that another anesthesiologist eventually took over, the record failed to reflect this change in management. Intubation was attempted several times. Patient #6's RR was 0 for 24 minutes, until 11:36 AM when intubation was successful. Manual ventilation was not documented.

CPR continued for 25 minutes. Paramedics were summoned and the patient was transferred to the main hospital ED at 11:53 AM. The clinical record identified that upon arrival to the ED, Patient #6 was coded again for approximately 50 minutes. The patient was vented, tissue plasminogen activator (tPA) was administered, therapeutic hypothermia and maximum pressor support were implemented. However, after discussion with the family, Patient #6 was made comfort measures only (CMO) and expired on 1/7/15 at 10:20 AM. Review of the autopsy report dated 2/20/15 indicated that the cause of death was hypertensive cardiovascular disease leading to cardio-pulmonary failure. Review of the record and interview with MD #14 identified that Patient #6's bradycardia and arrest were a result of the oculocardiac reflex.

Interview with the Chief of Anesthesiology on 8/13/15 at 2:00 PM identified that the anesthesia graph in the clinical record would capture "averages" of the respiratory rate (RR) and EKG rhythm in 15 minute intervals. The 10:45 AM - 11:00 AM interval identified the RR rate was 9 and the EKG identified normal sinus rhythm (NSR). The 11:00 AM - 11:15 AM interval indicated the RR was 0 and the EKG was NSR. The intraprocedure grid/graph failed to accurately reflect Patient 6's RR, IV propofol drip, and the patient's cardiac rhythm details within each of the 15 minute intervals.

Although the off-campus ambulatory surgical OR did not have a CPR policy or process in place to adequately document CPR measures, the hospital's Code Blue/White/254 Policy identified, in part the following: call a Code; dial 155; and a CPR flowsheet was used in all emergency situations to which the Code Blue/White team responds. MD responsibilities: manage code; assist with completion of the CPR evaluation sheet; and sign CPR flowsheet. RN responsibilities: activate code; apply AED; emergency equipment delivery; establish airway; ventilate with manual resuscitator bag; record treatment, medications administered and/or history of the events on the CPR Flowsheet; and complete CPR evaluation form immediately after a Code.

The record lacked a code resuscitation record (CPR Flowsheet) documenting Patient #6's arrest. The clinical record failed to reflect Patient #6's cardiac rhythm and/or rhythm strips of the critical event from 11:14 AM - 11:53 AM, and the record failed to reflect manual ventilation. MD #14's notation at 11:25 AM identified that Atropine x3, Epinephrine x4, Bicarb x1 and Calcium x1 were administered, but failed to reflect the administration times. The Medical Director of Quality Assurance, MD #1 indicated that the ambulatory surgical service did not need a CPR policy because "anesthesia" was present. However, the anesthesia record failed to reflect Patient #6's cardiac rhythm; manual ventilatory support and medication times during resuscitation and/or that the ambulatory surgical OR and anesthesia service had a CPR policy or process in place to adequately document CPR measures.

The Condition of Pharmaceutical Services has not been met as evidenced by:

Based on review of clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for 1 (Patient #5) of 10 patients with medication orders, the hospital pharmacy department failed to ensure that a policy was in place to direct the ordering of medications not found in the computerized medication order entry system and failed to ensure that a medication order for IV Amiodarone was compounded correctly which resulted in a overdose and death of a patient.


Please refer to A0501

Based on review of clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for 1 (Patient #5) of 10 patients with medication orders, the hospital pharmacy department failed to ensure that a policy was in place to direct the ordering of medications not found in the computerized medication order entry system and failed to ensure that a medication order for IV Amiodarone was compounded correctly which resulted in a overdose and death of a patient. The findings include:


Patient #5 was admitted to the hospital's Neonatal Intensive Care Unit (NICU) on 7/8/15 from another acute care hospital where the patient was delivered on 7/7/15 at 5:23 AM and had failed the Critical Congenital Heart Defect (CCHD) screen. Patient #5's diagnoses included transposition of the aorta (TGA), large ventricular septal defect (VSD), atrial septal defect (ASD), straddling mitral valve, mitral regurgitation, s/p atrial septostomy (7/18/15) and supraventricular tachycardia (SVT). Review of the clinical record identified that Patient #5 was receiving oral Propranolol and IV Adenosine for SVT treatment.
Review of the clinical record and interview with the Pediatric Cardiology Fellow, MD #9 on 8/11/15 at 12:00 PM identified that on the evening of 7/20/15, Patient #5 had an increase in the frequency of breakthrough SVT and required an IV Amiodarone loading dose. MD #9 indicated that in consultation with the Pediatric Cardiologist, MD #10, the decision was made to give a small IV loading dose of Amiodarone 2.5 mg/kg to be administered over 60 minutes.
Interview with PA #1 on 8/12/15 at 1:00 PM identified that per direction from MD #9, PA #1 ordered the Amiodarone IV through the hospital's CPOE system. Review of the medication orders entered by PA #1 indicated that the first IV Amiodarone order (197168815) was entered at 11:15 PM on 7/20/15 that directed IV bolus 8.98 mg, route: IV, frequency: bolus from syringe over 5 minutes. PA #1 indicated that he/she did not enter the bolus from syringe over 5 minutes in the original order. Interview with the Manager of Medication Safety on 8/12/15 at 1:45 PM identified that the frequency of the medication may have been a "default" entry auto-populated by the computer system.
MD #9 identified that he/she was called on 7/21/15 at 1:14 AM by PA #1, who reported that approximately half-way through the Amiodarone IV infusion, Patient #5 became severely bradycardic, apneic, with desaturation to the 30's and the Amiodarone infusion was stopped. Patient #5 was resuscitated for 2 hours, resuscitation efforts were unsuccessful and Patient #5 was pronounced expired on 7/21/15 at 3:14 AM. MD #9 identified that in consultation with pharmacy staff, it was identified that there had been an accidental misdosing (compounding error) of the Amiodarone.
Review of the clinical record and interview with PA #1 on 8/12/15 at 1:00 PM identified that Patient #5 weighed 3.59 kg and based on calculation, should have received a total of 8.98 mg of IV Amiodarone, but received approximately 75 mg in error.
Interview with Pharmacist #1 on 8/18/15 at 2:00 PM and 8/20/15 at 2:00 PM indicated that Patient #5's first Amiodarone order directed bolus from syringe in the CPOE system of the computerized medical record system EPIC. However, Pharmacist #1 identified that Patient #5 did not have an IV drip hanging for the bolus and the order did not have a rate and diluent ordered.
Pharmacist #1 identified that EPIC did not have (pediatric/newborn) Amiodarone IV available in the database selection in the order set. Pharmacist #1 communicated to PA #1 that he/she would have to manipulate the Amiodarone order in order to enter it into EPIC. According to policy, a Pharmacist is able to take a verbal order from an Authorized Prescriber (AP).
Pharmacist #1 attempted to customize the Amiodarone order, reentered it numerous times, and ultimately entered it as a "Hard to Enter Medication" on 7/20/15. The second IV Amiodarone order (197168821) was entered at 11:40 PM by Pharmacist #1 as "Hard to Enter Medication" that directed dose: 1 each, route: other, frequency: once and administering instructions: Amiodarone 8.98 mg/D5W 8.98 ml to infuse over 5 minutes as bolus. This order was discontinued by Pharmacist #1 at 11:50 PM.
The third IV Amiodarone order (197168822) entered at 11:50 PM by Pharmacist #1 directed 8.98 mg in dextrose 5% (DEHP-FREE) 100 ml (1mg/ml) peripheral line IV infusion (newborn), frequency: continuous over 1 hour. On interview, Pharmacist #1 identified that the IV Amiodarone order could not be entered correctly into the CPOE EPIC database system because the computerized medication system identified that the infusion rate was too high.
Pharmacist #1 entered the fourth Amiodarone order at 11:52 PM as "Hard to Enter Medication" (197168823), dose: 1 each, route: other. The order included instructions: Amiodarone 8.98 mg/D5W 8.98 ml, infuse over 1 hour. Pharmacist #1 identified that this order was finally accepted by the computer into DoseEdge (Pharmacy computerized IV compounding system) from EPIC.
Pharmacist #1 indicated that "Hard to Enter" orders were considered verbal orders. Review of the Orders for Patient Care or Research Policy identified in part, in all instances of verbal orders, the order was written down by Hospital staff authorized to accept and record verbal orders, read back to the prescriber and then entered as verbal orders in the clinical information system. Such orders were validated by an Authorized Prescriber (AP) with the next use of CPOE. Verbal orders shall meet all requirements of a Valid Order .... To be valid, an order must contain enough information for the staff to understand what was requested ...and must contain the name of the desired drug, the dose to be administered, the route and the frequency. Also, the policy indicated that no other caregiver has the authority, except under power of an approved protocol, to discontinue an active AP order.
Review of the clinical record identified that each of the Amiodarone orders dated 7/20/15: #197168821, #197168822 and #197168823 with the mode: "Ordering in Verbal with readback: cosign required," had not been electronically signed/authenticated by PA #1 until 8/4/15. Review of the Medication Management Policy identified that dating, timing and authenticating of standing orders and protocols by the ordering practitioner or another practitioner responsible for the patient's care was completed in accordance with professional standards of practice; law and regulation; hospital policies; and medical staff bylaws, rules and regulations.
Although the hospital failed to have a policy to address the process of entering "Hard to Enter" medications at the time of the event, review of the policy (dated July 31, 2015) Compounding IV Sterile Products Outside of DoseEdge: "Hard to Enter" IV Medication Orders identified that for an order to pass accurately into DoseEdge, the order screen must be built properly in EPIC to send all components into DoseEdge through an interface. "Hard to Enter" EPIC orders were considered compounding OUTSIDE of DoseEdge.
Review of Patient #5's clinical record, review of the "All Orders" printout dated 8/10/15 and interviews with hospital personnel failed to reflect that a complete and authenticated IV Amiodarone medication order was written/entered/maintained in the patient record. Amiodarone orders generated on 7/20/15 were not authenticated by PA #1 until 8/4/15 despite PA #1 accessing Patient #5's clinical record on 7/21/15 at 4:23 PM to document a discharge summary.
Patient #5's death certificate identified the cause of death as asystole due to complete cardiac heart block.

Based on review of the clinical records, review of hospital policy, review of hospital documentation and interviews with hospital personnel for one (Patient #6) of 10 patients who underwent surgery, the hospital failed to ensure that therapeutic measures of CPR were accurately documented and/or that the ambulatory surgical OR and anesthesia service had a policy or process in place to adequately document CPR measures. The findings include:

Patient #6 was admitted to the hospital's ambulatory surgical OR on 1/6/15 at 6:14 AM for a right pars plana vitrectomy, endolaser and right scleral buckle. Review of the clinical record identified that the patient's past medical history included pneumothorax and dislocated shoulder; home medications included Lamictal and Depakote. Review of the record and interview with the surgeon, MD #13 on 9/14/15 at 10:25 AM identified that Patient #6 had a pre-operative workup and was medically cleared (including an EKG and echocardiogram cleared by a cardiologist). Review of the anesthesia record and interview with the anesthesiologist, MD #14 on 9/9/15 at 9:20 AM identified that MD #14 completed the pre-procedure anesthesia evaluation and informed consent was verbally obtained. The primary anesthesia plan was ASA 2 and MAC. Anesthesia started at 7:40 AM and the procedure start time was 7:59 AM. Review of the anesthesia intraprocedure grid/graph dated 1/6/15 and interview with MD #14 identified that the patient's baseline heart rate was low 50's and RR was 12 (normal 12-20) with 2 liters of oxygen (O2) via nasal cannula (NC).

Review of the clinical record and interview with MD #14 on 9/9/15 at 9:20 AM identified that during the surgery Patient #6 became bradycardic twice (11:14 AM and 11:16 AM) due to eye manipulation (oculocardiac reflex). MD #14 could not recall what the patient's heart rate (HR) and/or the rhythm were at that time. MD #14 administered Atropine IV and indicated that Patient #6 did not respond to the Atropine administered at 11:16 AM. The anesthesia report identified Patient #6 received a total of the following IV medications during the surgery (prior to the arrest): Versed 4 mg; Alfentanil 1000 mcg; Propofol 482.6 mg and Fentanyl 100 mcg. Patient #6 did not receive any reversal agents.

Upon surveyor inquiry, MD #14 did not recall if the patient was breathing at 11:14 AM. However, the record indicated that the patient's RR was 0 from 11:12 AM - 11:16 AM with an oxygen saturation (SpO2) of 82-88% on 2L of O2 via NC. The oxygen was increased to 4L O2 via NC at 11:14 AM and the IV Propofol drip was discontinued. The record also identified that Patient #6's HR increased from the 50's to the 80's during that time. Patient #6's last blood pressure obtained was recorded at 11:09 AM, 110/70.

MD #14 identified that Patient #6 did not have a radial or carotid pulse at 11:17 AM. SpO2 was 48% and the O2 was increased to 10L. MD #14 called "anesthesia stat" and compressions were started at 11:18 AM. The record failed to reflect who performed compressions, how long the compressions were continued and/or if the compressions were effective. Although, MD #14 identified that initially he/she directed the code and that another anesthesiologist eventually took over, the record failed to reflect this change in management. Intubation was attempted several times. Patient 6's RR was 0 for 24 minutes, until 11:36 AM when intubation was successful. Manual ventilation was not documented.

CPR continued for 25 minutes. Paramedics were summoned and the patient was transferred to the main hospital ED at 11:53 AM. The clinical record identified that upon arrival to the ED, Patient #6 was coded again for approximately 50 minutes. The patient was vented, tissue plasminogen activator (tPA) was administered, therapeutic hypothermia and maximum pressor support were implemented. However, after discussion with the family, Patient #6 was made comfort measures only (CMO) and expired on 1/7/15 at 10:20 AM. Review of the autopsy report dated 2/20/15 indicated that the cause of death was hypertensive cardiovascular disease leading to cardio-pulmonary failure. Review of the record and interview with MD #14 identified that Patient #6's bradycardia and arrest were a result of the oculocardiac reflex.

Interview with the Chief of Anesthesiology on 8/13/15 at 2:00 PM identified that the anesthesia graph in the clinical record would capture "averages" of the respiratory rate (RR) and EKG rhythm in 15 minute intervals. The 10:45 AM - 11:00 AM interval identified the RR rate was 9 and the EKG identified normal sinus rhythm (NSR). The 11:00 AM - 11:15 AM interval indicated the RR was 0 and the EKG was NSR. The intraprocedure grid/graph failed to accurately reflect Patient 6's RR, IV propofol drip, and the patient's cardiac rhythm details within each of the 15 minute intervals.

Although the off-campus ambulatory surgical OR did not have a CPR policy or process in place to adequately document CPR measures, the hospital's Code Blue/White/254 Policy identified, in part the following: call a Code; dial 155; and a CPR flowsheet was used in all emergency situations to which the Code Blue/White team responds. MD responsibilities: manage code; assist with completion of the CPR evaluation sheet; and sign CPR flowsheet. RN responsibilities: activate code; apply AED; emergency equipment delivery; establish airway; ventilate with manual resuscitator bag; record treatment, medications administered and/or history of the events on the CPR Flowsheet; and complete CPR evaluation form immediately after a Code.

The record lacked a code resuscitation record (CPR Flowsheet) documenting Patient #6's arrest. The clinical record failed to reflect Patient #6's cardiac rhythm and/or rhythm strips of the critical event from 11:14 AM - 11:53 AM, and the record failed to reflect manual ventilation. MD #14's notation at 11:25 AM identified that Atropine x3, Epinephrine x4, Bicarb x1 and Calcium x1 were administered, but failed to reflect the administration times. The Medical Director of Quality Assurance, MD #1 indicated that the ambulatory surgical service did not need a CPR policy because "anesthesia" was present. However, the anesthesia record failed to reflect Patient #6's cardiac rhythm; manual ventilatory support and medication times during resuscitation and/or that the ambulatory surgical OR and anesthesia service had a CPR policy or process in place to adequately document CPR measures.