The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

METHODIST HEALTHCARE MEMPHIS HOSPITALS 1265 UNION AVE SUITE 700 MEMPHIS, TN 38104 Aug. 16, 2019
VIOLATION: PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT Tag No: A0145
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on standards of practice, review of hospital policies and procedures, document review, medical record review and interview, the hospital failed to ensure patients were free from all forms of abuse and neglect and received the necessary care and services to prevent physical harm when pharmacists failed to correctly calculate a dose of medication based on a verbal order, neglected to ensure a written order was completed for the medication, neglected to label the medication bag and syringes, and neglected to ensure all Pediatric Intensive Care Unit (PICU) Registered Nurses (RN) implemented medication policies and procedures pertaining to the administration of medications for 1 of 3 (Patient #1) patients reviewed who received Esmolol; which is a class II antiarrhythmic - an extremely short acting antiarrhythmic medication used for the management of hypertension and tachycardia (a faster than normal heart rate).

The failure of the hospital to ensure all staff involved with medication administration followed standards of practice and hospital policies and procedures to prevent physical harm to patients resulted in a fatal medication error for Patient #1 and placed all patients in a SERIOUS and IMMEDIATE THREAT of their health and safety and placed them in IMMEDIATE JEOPARDY for risk of serious injuries and/or death.

The findings included:

1. Medical record review for Patient #1 revealed the patient was admitted to the hospital Pediatric Intensive Care Unit (PICU) on 6/10/19 with diagnoses that included [DIAGNOSES REDACTED][DIAGNOSES REDACTED] (a rare disorder that causes blood vessel inflammation throughout the body), [DIAGNOSES REDACTED] Obstructive [DIAGNOSES REDACTED], (the heart muscle becomes thick and makes it harder for the heart to pump blood) and [DIAGNOSES REDACTED] (the blood takes longer to clot). The patient's weight was 30 kilograms (kg).

The Risk Manager confirmed any patient weighing less than 50 kg kilograms was treated as a pediatric patient regardless of the patient's chronological age, and would receive a smaller dose of medication than an adult.

On 6/12/19 at 7:33 AM Physician #7 wrote an order for Patient #1 to be started on an Esmolol drip for persistent tachycardia. The physician's order stated the patient was to receive Esmolol 25 micrograms (mcgs) per kilograms (kg) to infuse over 43.4 hours and to replace the Esmolol infusion bag every every 24 hours. The physician's order was verified as correct by the hospital Pharmacist.

Patient #1 continued to receive the Esmolol drip from 6/12/19 - 6/23/19 with each Esmolol drip dosage order during this time period verified as correct by a hospital Pharmacist.

On 6/24/19 at 12:37 AM Physician #7 suspended the Esmolol order (held the Esmolol drip and was not giving it). Review of the Medication Administration Record revealed Patient #1 did not receive the Esmolol after the medication was suspended.

On 6/28/19 at 10:05 AM Physician #7 completely discontinued the Esmolol.

Review of a physician progress note dated 7/27/19 revealed Physician #1 documented Patient #1's condition had worsened. Patient #1's heart rate had increased to around 120 beats per minute, the patient's respiratory rate was between 30 - 40 breaths per minute, and the patient's oxygen saturation (O2 Sat) was 73 (normal being 90 - 100). The physician documented Patient #1 needed to be intubated (a breathing tube inserted in the patient's airway) in order to supply the patient with more oxygen.

Preparations were made to intubate Patient #1 by having an echocardiogram (Echo) machine (an ultrasound that shows the movement of the heart) placed at the patient's bedside in order to monitor the patient's heart; and by having a special team (called a Harvey Team) on stand-by in the patient's room in case the patient's heart stopped beating.

On 7/27/19 at 5:13 PM Patient #1 was intubated successfully. The Echo machine showed the patient's heart movement with a heart rate of 139, the patient's Blood Pressure (BP) was 90/47, and the patient's O2 Sat was 86.

At 5:18 PM Patient #1's heart rate was 140, the patient's BP was left blank, and the patient's O2 Sat was 82.

Review of the Harvey Team form dated 7/27/19 at 5:18 PM revealed Registered Nurse (RN) #1 administered a 60 milliliter (ml) syringe of Esmolol to Patient #1 (to lower the patient's heart rate). There was no physician order on the Harvey Team form for the Esmolol or the name of a physician who had requested the nurse to administer the Esmolol. A bag of Esmolol labeled 2000 milligrams (mg) in 100 ml had been brought to Patient #1's room by Pharmacist #1.
RN #2 and RN #3 who were also in Patient #1's room, had drawn up a 60 ml syringe and a 40 ml syringe of Esmolol from the 2000 mg per 100 ml bag and given it to RN #1 to administer to the patient. There was no documentation of a physician order for the Esmolol bolus. (Later at 8:09 PM, Physician #1 wrote a note in the patient's medical record which stated she had decided to administer the Esmolol bolus at 5:18 PM but didn't know what dose to administer and didn't write an order).
The hospital failed to ensure a complete medication order with the does, strength and the name of the medication was written or electronically entered and was dated and timed for the administration of the Esmolol. There was no evidence the hospital staff double checked the amount of Esmolol to be administered. There was no documentation the RN had verified the dose and strength of the unfamiliar drug Esmolol before administration of the drug.

On 7/27/19 at 5:21 PM, three minutes after the RN had begun administering the Esmolol, the Harvey Team documented on the form that Patient #1's heart beat completely stopped and the patient was no longer breathing.

At 5:21 PM RN #1 began chest compressions on Patient #1 in an attempt to re-start the patient's heart rate and the Harvey Team attempted to resuscitate (revive a patient who's heart beat had stopped) Patient #1.

Attempts to resuscitate Patient #1 were unsuccessful and the patient was pronounced dead on 7/27/19 at 5:26 PM.

Surveyor observation of the Esmolol bag that had been used to draw-up and administer the 60 ml bolus of Esmolol to Patient #1 revealed the bag was labeled "2000 mg/100 ml".
Patient #1 had been administered a fatal dose of Esmolol totaling 1,200 mg (400 mg/kg). Instead of 60 ml of Esmolol, the patient should have been administered 0.15 ml of Esmolol.

2. During an interview on 8/13/19 at 10:05 AM in the hospital's Risk Office, Physician #1 confirmed she was the attending physician for Patient #1.
Physician #2 (Division Chief and fell owship Director), and Physician #3 (PICU fell ow) were also present during the interview.
Physician #1 was asked about the incident leading up to the Esmolol overdose for Patient #1.
Physician #1 stated she was not sure of the correct bolus dose for Esmolol and she asked Pharmacist #1 who was in Patient #1's room what would be the correct bolus dose. Pharmacist #1 left the patient's room, went to the pharmacy and brought back a bag of Esmolol.
Pharmacist #1 told Physician #1 the bolus dose of Esmolol should be 100 mcg/kg of body weight and based on Patient #1's weight of 30 kg the bolus dose would be 3,000 mcg, which would be 0.15 mL
Physician #1 was asked if she looked at the bag of Esmolol brought to the room by the Pharmacist and she stated that she did not.
Physician #1 stated Pharmacist #1 handed the bag of Esmolol to RN #2.
Physician #1 stated RN #2 asked Pharmacist #1 should the entire Esmolol bag be administered, and Pharmacist #1 said yes.
Physician #1 stated the RN drew up 2 syringes of the Esmolol from the bag until the bag was empty.
Physician #1 stated, "I am not sure if there was any questions regarding the dose...While Patient #1 was receiving the Esmolol, as I was watching the monitor and the Echo, her [Patient #1] heart rate got to 100 and I said stop. The first syringe [which was 60 ml] was empty but the second syringe [which was 40 ml] was not pushed [had not been given]...[Named Physician #4] a third year cardiologist was doing the Echo...He stated her heart is not squeezing, then he said give her a full dose [Epi - a medication to stimulate the heart ] because her heart is not squeezing. We could not palpate a rate, we started CPR [cardiopulmonary resuscitation]...The Nurse Practitioner [NP] was the first one to question the dose...I went to the pharmacy and spoke to [named Pharmacist #1 and #3]. I asked did we give too much Esmolol. Somehow we very quickly realized the bag was dosed in milligrams not in micrograms. Pharmacist #1 said she read it as micrograms".
Micrograms (mcg) would be a smaller dose than milligrams (mg).

During an interview on 8/14/19 at 11:06 AM in the hospital Risk office RN #3 was asked what his involvement was during the incident with Patient #1 and the Esmolol administration and RN #3 stated, "I drew up the Esmolol [into a syringe]".
RN #3 continued stating RN #2 also drew up some Esmolol into a syringe.
RN #3 stated, "1 had a 60 ccs [ml] and the other had 40 [ml]. We emptied the bag."

During a telephone interview on 8/14/19 at 11:27 AM RN #2 stated she was in Patient #1's room during the time the patient was intubated and when the patient's heart stopped beating. RN #2 stated she held the Esmolol bag while RN #3 drew up the first syringe with 60 ml of Esmolol, and RN #2 stated she had drawn up the second syringe with 40 ml of Esmolol.
RN #2 stated she did not look at the Esmolol bag to verify the dose in the bag.
RN #2 stated RN #1 was pushing it (giving the Esmolol to the patient intravenously) slow over 1 minute.
RN #2 stated that Physician #1 asked for someone check for Patient #1 for a heart rate and RN#2 stated, "I checked and didn't feel one...I did a femoral Doppler [an ultrasound machine that shows/measures blood flow] and no pulse..."

During a telephone interview on 8/14/19 at 2:36 PM in the hospital's Risk office RN #1 stated he was handed the Esmolol 60 ml bolus that had been drawn from the bag of Esmolol.
RN #1 stated he asked Pharmacist #1 and Physician #1 if he should give the whole 60 ml because it seemed like a lot.
RN #1 stated that the pharmacist and the physician looked at each other and the pharmacist stated, "Yes, the whole thing."
RN #1 stated that no one stopped to look at the Esmolol bag concentration.
RN #1 confirmed there was no label on the syringe.
RN #1 stated that he administered the entire 60 mL of Esmolol to Patient #1.

During an interview on 8/13/19 at 3:38 PM in the hospital's Risk office Pharmacist #3 was asked what happened with Patient #1 and the Esmolol bolus and the Pharmacist stated, "Pharmacist #1 came down [to the pharmacy] and said [Named Physician #4] had requested a bolus of Esmolol...Pharmacist #2 pulled [looked up] Esmolol in the computer and it said the loading or bolus dose was between 100 and 200 mcg/kg. We went with 100 [mcg/kg] and calculated 3,000 mcg, her weight was around 30 kg..."
Pharmacist #3 was asked if he discussed the volume and he stated, "we did not specifically discuss the volume. We discussed the dose. They left and went back to the room. Next thing [Named Pharmacist #2] said to me was [Named Pharmacist #1] needs you now...[Named Pharmacist #1] said to me - I think we gave the wrong dose. I asked her how much did you give. She stated about 50 ccs [ml] were given...maybe 5 minutes later...when we got back to the pharmacy we re-did the math. Patient #1 had received 333% too much...The concentration was not right I assumed...I heard 50 ccs [ml] went in."

During an interview on 8/14/19 at 12:03 PM in the hospital's Risk office Pharmacist #1 was asked to share her involvement with Patient #1 and the Esmolol. Pharmacist #1 stated that she looked at the bag of Esmolol after she walked into Patient #1's room and thought it read "2,000 mcg/100 mL".
Pharmacist #1 stated, "...I had never done a bolus with Esmolol before. I don't know that I have done an infusion for Esmolol. It's not super common."
Pharmacist #1 stated after the Esmolol had been administered to Patient #1 and after the patient's heart rate had stopped, she asked to see the Esmolol bag. Pharmacist #1 stated, "At that point I thought the bag was in micrograms, but I needed to double check it".
Pharmacist #1 was asked if she had looked at the bag a second time would she have noticed the concentration and she stated, "I don't think looking at the bag a second time would have changed anything. We all were unfamiliar with the dosing from the start."

The hospital neglected to list the medication Esmolol as a high risk medication which required a double-check system prior to administration; and failed to ensure physicians, pharmacists and nurses did not prepare and administer medications with unusual doses or unfamiliar medications prior to confirming the medication and dose with other qualified healthcare providers prior to administration.

Patient #1 had previously received an Esmolol drip during this hospitalization with no adverse outcomes. A hospital pharmacist had calculated and verified the Esmolol for the Esmolol drip the patient had received.

During an interview on 8/15/19 at 2:45 PM in the hospital's Risk office the Regulatory Manager (RM) when asked about writing orders for medications the RM stated the hospital taught all the physicians that any doses of emergency drugs administered during a patient cardiac arrest (a patient's heart stops beating) do not have to be a written order because the doses are listed on the Harvey Team Record. The RM stated the Harvey Team record was signed by the physician and put in the patient's chart, therefore it was considered a written order.
The RM confirmed the dose of Esmolol was not administered to the patient during the patient's cardiac arrest.
The RM confirmed the Esmolol was not on the list of emergency cardiac medications.
The RM confirmed the writing on the Harvey Team record that the patient received of 60 ml of Esmolol administered was not a complete physician order for the Esmolol.

During an interview on 8/15/19 at 10:45 AM in the hospital Risk office when asked what interventions had been put into place following the incident with Patient #1 and the Esmolol, the Director of Pharmacy stated she sent out an email the following Monday 7/29/19 at 4:05 PM (incident occurred on Saturday 7/27/19) to the hospital's pharmacy team that stated, "We have had a medication event involving Esmolol. Effective Immediately - Esmolol will require an order and label upon dispensing, even if needed in an emergency situation. If the pharmacist is entering the order, please enter through powerchart so that another pharmacist can verify..."

This email addressed only the drug Esmolol, no other antiarrhythmic medications. The Director of Pharmacy confirmed the email was sent only to this specific hospital's pharmacy team, and not to all the hospitals associated with this hospital's provider number.

The hospital Physician #1, RNs and Pharmacists failed to verify the dose or the concentration of the Esmolol in the bag and failed to ensue the correct dose that should be administered to Patient #1. Pharmacy was unable to verify the order because there was no written order entered in the medication ordering system.

Patient #1 should have received 100 mcg/kg times 30 kg = 3,000 mcg/0.15 mL. per the verbal order. (The verbal order did not identify the volume).
Patient #1 actually received 1,200,000 mcg/60 mL. This was a 400% overdose.

There was no written order in Patient #1's medical record for the Esmolol that was administered on 7/27/19 at 5:18 PM.

3. The "Tennessee Code Annotated Title 68...Chapter 11...Part 2..." documented, "...68-11-211..."Neglect" means the failure to provide goods and services necessary to avoid physical harm...". The hospital failed to provide medication administration according to hospital policies and procedures and standards of practice which resulted in a patient's death after receiving a fatal dose of Esmolol.

Review of State Operations Manual, Appendix A Survey Protocol, Regulations, and Interpretative Guidelines for Hospitals revealed, "...482.13(c)(3)...The intent of this requirement is to prohibit all forms of abuse, neglect (as a form of abuse) and harassment whether from staff... The hospital must ensure that patients are free from all forms of abuse, neglect, or harassment. The hospital must have mechanisms/methods in place that ensure patients are free of all forms of abuse, neglect... Abuse is defined as willful infliction of injury... This includes staff neglect... Neglect... is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness..."
The hospital staff neglected to ensure the correct dosage of the medication Esmolol and administered a fatal dose to Patient #1.

Review of the hospital's policy Double Check (Independent) of Specified High Risk Medications documented, "...An "independent double check"...is required only on SPECIFIED high risk medications...Double checking is only beneficial in preventing errors when the double check is performed independently...In the "Independent Double Check Process," the first provider is the one who prepares, dispenses, or administers the medication. The second provider verifies the preparation or administration is correct without receiving verbal instructions from the first provider...Double checks of medication that are not specified as high risk medications may be performed at the discretion of the provider (for example: unfamiliar with the medication, etc)...Calculations...First Provider...Independently calculates the following (as appropriate for order)...Dosage ordered safe with weight (verify in kg)...Volume to be administered (consider dosage ordered and concentration)...Second Provider independently calculates the same items as the first provider... Preparation...First Provider...Prepare labels as appropriate...High concentration label as appropriate...Drug name, dosage, route, rate...Medication concentration...Second Provider...Reviews independently after complete: Order/MAR...Original packaging...Prepared medication...All labels..."
The hospital failed to list the medication Esmolol as a medication that required a double check.

Review of a document titled "Esmolol" retrieved from the website for the National Center for Biotechnology Information (NCBI) revealed Esmolol (Esmolol hydrochloride) is indicated in sinus tachycardia. Esmolol is a class II antiarrhythmic agent. Esmolol is administered intravenously. The document further revealed that an overdose of Esmolol can result in signs of cardiac toxicity that include bradycardia, which is defined as any heart rate rhythm disorder below 60 beats per minute, asystole (no heart rate) and Pulseless Electrical Activity (PEA) which is no palpable pulse. The document further stated that pediatric dosages have been experimental and are not approved by the Food & Drug Administration (FDA).
The hospital failed to ensure the medication Esmolol was listed as a class II antiarrhythmic medication along with the signs/symptoms of [DIAGNOSES REDACTED]

Review of the document "ISMP (Institute for Safe Medication Practices) List of High-Alert Medications in Acute Care Settings...2018" documented, "...High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error...Classes/Categories of Medication...antiarrhythmic's, IV [Intravenous]..."
The hospital failed to list Esmolol as a High-Alert medication.

The hospitals antiarrhythmic class of medication for Esmolol (an extremely short acting antiarrhythmic medication used for the management of hypertension and tachycardia) was not listed in the hospital's policy as a high risk medication.

Review of the "Lippincott Manual of Nursing Practice 10th Edition" documented, "...NURSING ALERT: Unusual dosages or unfamiliar drugs should always be confirmed with the health care provider and pharmacist before administration. The nurse is ultimately accountable for the drug administered..."
The hospital failed to ensure nursing staff confirmed the dosage with the physician and the pharmacist prior to administering the medication.

Review of the document titled "Esmolol Hydrochloride in Water for Injection" retrieved from the FDA website revealed "bolus doses of Esmolol in the range of 625 mg. (milligrams) to 2.5 grams (12.5 to 50 mg/kg) have been fatal".
The hospital failed to recognize the range of Esmolol that would be fatal if administered. A fatal dose was administered to Patient #1.

A review of the hospital's policy Medication Administration documented, "...Before administration, the individual administering the medication verifies the following...Medication selected matched the medication order and product label...For weight based medications, the medication dose should be reviewed for appropriateness related to the patient's weight...6 rights (medication, patient, time, dose, route, indication). The 6 rights are validated by comparing the medication order or MAR [Medication Administration Record], the medication label(s) (including pharmacy label and manufacturer label when applicable)...Any questions regarding the medication should be resolved with the prescriber or other staff involved (ex: pharmacy etc.) prior to administration...DOCUMENTATION...Medications
...are documented on the MAR or a procedural document...the MAR should include the following information...Dose...Person that administered..."
The hospital failed to ensure the individual administering the medication verified the medication order, failed to ensure the correct dose, failed to ensure labels were affixed to the syringe prior to use, failed to ensure the medication was appropriate for Patient #1's weight, and failed to ensure the nurse documented in the MAR the dose that Patient #1 received.

A review of the hospital's Unified Medical Staff General Rules and Regulations revealed, "...A complete medication order will include the following: Date of order, name of drug...time of order, dose, dosing interval or frequency, route of administration...Legible signature of prescribing practitioner...or appropriate electronic signature...Medication orders must be dated and timed..."
The hospital failed to ensure a complete medication order was written or electronically entered and was dated and timed.

A review of the hospital's Clinical Pharmacist job description documented, "...Advises physicians, healthcare staff, students, residents and patients in the safe administration of medication...and ensures compliance with policies and procedures for medication safety, regulatory requirements, quality standards..."
The hospital failed to ensure the Clinical Pharmacist oversaw and advised the physician, the resident and healthcare staff in the safe administration of medication and ensured medication safety.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on standards of practice, hospital policies and procedures, observation and interview, the hospital failed to ensure the nursing services' approach to medication administration followed acceptable standards of practice and the hospital policies and procedures which promoted safety while administering medications and decreased the likelihood of medication errors.

The failure of the hospital to ensure nursing services implemented safety interventions during medication administration resulted in 1 of 3 (Patient #1) receiving a fatal dose of the medication Esmolol and placed all patients in a SERIOUS and IMMEDIATE THREAT and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death.

The findings included:

1. The hospital failed to ensure nursing standards of practice and medication policies and procedures were followed and implemented during medication administration of the drug Esmolol which resulted in the fatality of Patient #1.
Refer to A 395.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on standards of practice, review of hospital policies and procedures, document review, medical record review and interview, the hospital failed to ensure all Pediatric Intensive Care Unit (PICU) Registered Nurses (RN) implemented standards of practice and implemented medication policies and procedures pertaining to, preparing, administration and documentation of medication administration for 1 of 3 (Patient #1) patients reviewed who received Esmolol (a class II antiarrhythmic - an extremely short acting antiarrhythmic medication used for the treatment of hypertension and tachycardia). The 3 of 3 (RN #1, #2 and #3) RNs in the patient's room failed to look at the Esmolol bag to verify the dose, and strength of the Esmolol while preparing the medication for administration,

The failure of the hospital to ensure all nursing staff involved with medication administration followed standards of practice and hospital policies and procedures to prevent physical harm to patients resulted in a fatal medication error for Patient #1 and placed all patients in a SERIOUS and IMMEDIATE THREAT of their health and safety and placed them in IMMEDIATE JEOPARDY for risk of serious injuries and/or death.

The findings included:

1. Medical record review for Patient #1 revealed the patient was admitted to the hospital Pediatric Intensive Care Unit (PICU) on 6/10/19 with diagnoses that included [DIAGNOSES REDACTED][DIAGNOSES REDACTED] (a rare disorder that causes blood vessel inflammation throughout the body), [DIAGNOSES REDACTED] Obstructive [DIAGNOSES REDACTED], (the heart muscle becomes thick and makes it harder for the heart to pump blood) and [DIAGNOSES REDACTED] (the blood takes longer to clot). The patient's weight was 30 kilograms (kg).

The Risk Manager confirmed any patient weighing less than 50 kg kilograms was treated as a pediatric patient regardless of the patient's chronological age.

On 7/27/19 at 5:13 PM RN #1, RN #2 and RN #3 were in the room of Patient #1 while the patient was being intubated (a procedure where a tube is placed in the patient to help the patient breath better) successfully.

On 7/27/19 at 5:18 PM, Pharmacist #1 brought a bag of Esmolol to Patient #1's room and stated the patient should receive 3000 micrograms (mcgs), which equaled 0.15 milliliters (ml), of Esmolol to treat the patient's fast heart rate of 140. Micrograms is smaller than milligrams. RN #2 and RN #3 drew up 60 ml and 40 ml of Esmolol from the bag which was labeled 2000 milligrams per 100 ml bag of Esmolol. There was no documentation the 3 RNs observed the bag of Esmolol to verify the medication's name, strength and dose. There was no documentation of a physician's order for the Esmolol. There was no documentation the 3 RNs requested a physician's order, or verified the amount of Esmolol that should be administered to a Patient weighing 30 kg. Based on a verbal order from Pharmacist #1, RN #1 took the 60 ml syringe of Esmolol and administered it intravenously to Patient #1.

On 7/27/19 at 5:21 PM, three minutes after the RN had administered the Esmolol to the Patient #1, the Harvey Team staff ( a special team of healthcare staff trained in emergencies) documented Patient #1's heart beat completely stopped and the patient was no longer breathing.

At 5:21 PM RN #1 began chest compressions on Patient #1 in an attempt to re-start the patient's heart rate and the Harvey Team staff attempted to resuscitate the patient (revive a patient who's heart has stopped).

Attempts to resuscitate Patient #1 were unsuccessful and the patient was pronounced dead on 7/27/19 at 5:26 PM.

Surveyor observation of the Esmolol bag that had been used to draw-up and administer the 60 ml bolus of Esmolol to Patient #1 revealed the bag was labeled "2000 mg/100 ml".
Patient #1 had been administered a fatal dose of Esmolol totaling 1,200 mg (400 mg/kg).
After the Esmolol had been administered to the patient and after the patient had expired, based on correct pharmacy calculations of the drug Esmolol, Patient #1 should have only received 0.15 ml instead of the 60 ml the RN had administered to the patient.
Patient #1 had been administered a 400% overdose of the Esmolol.

2. During an interview on 8/13/19 at 10:05 AM in the hospital's Risk Office, Pharmacist #1 stated the bag of Esmolol was given to RN #2. Pharmacist #1 stated RN #2 asked if the entire 100 ml bag should be administered, and Pharmacist #1 said yes.
Physician #1 (who was also in the Patient's room during the procedure) stated the RN drew up 2 syringes of the Esmolol from the bag until the bag was empty.
Physician #1 stated, "I am not sure if there was any questions regarding the dose...While Patient #1 was receiving the Esmolol, as I was watching the monitor and the Echo, her [Patient #1] heart rate got to 100 and I said stop. The first syringe [which was 60 ml] was empty but the second syringe [which was 40 ml] was not pushed [had not been given...The Nurse Practitioner [NP] was the first one to question the dose..."

During an interview on 8/14/19 at 11:06 AM in the hospital Risk office RN #3 was asked what his involvement was during the incident with Patient #1 and the Esmolol administration and RN #3 stated, "I drew up the Esmolol [into a syringe]".
RN #3 continued stating RN #2 also drew up some Esmolol into a syringe.
RN #3 stated, "1 had a 60 ccs [ml] and the other had 40 [ml]. We emptied the bag."

During a telephone interview on 8/14/19 at 11:27 AM RN #2 stated she was in Patient #1's room during the time the patient was intubated and when the patient's heart stopped beating. RN #2 stated she held the Esmolol bag while RN #3 drew up the first syringe with 60 ml of Esmolol, and RN #2 stated she had drawn up the second syringe with 40 ml of Esmolol.
RN #2 stated she did not look at the Esmolol bag to verify the dose in the bag.
RN #2 stated RN #1 was pushing it (giving the Esmolol to the patient intravenously) slow over 1 minute.

During a telephone interview on 8/14/19 at 2:36 PM in the hospital's Risk office RN #1 stated he was handed the Esmolol 60 ml bolus that had been drawn from the bag of Esmolol.
RN #1 stated he asked Pharmacist #1 and Physician #1 if he should give the whole 60 ml because it seemed like a lot.
RN #1 stated that the pharmacist and the physician looked at each other and the pharmacist stated, "Yes, the whole thing."
RN #1 stated that no one stopped to look at the Esmolol bag concentration.
RN #1 confirmed there was no label on the syringe.
RN #1 stated that he administered the entire 60 mL of Esmolol to Patient #1.

3. According to RN.com, nurses are often the last "gatekeeper" in the administration process to prevent medication errors. It is important to take the time needed to ensure patient safety.
The essential environmental conditions conducive to safe medication practices include the right to complete and clearly written orders that clearly specify the drug, and dose. .

Review of the "Lippincott Manual of Nursing Practice 10th Edition" documented, "...NURSING ALERT: Unusual dosages or unfamiliar drugs should always be confirmed with the health care provider and pharmacist before administration. The nurse is ultimately accountable for the drug administered..."

A review of the hospital's policy Medication Administration documented, "...Before administration, the individual administering the medication verifies the following...Medication selected matched the medication order and product label...For weight based medications, the medication dose should be reviewed for appropriateness related to the patient's weight...6 rights (medication, patient, time, dose, route, indication). The 6 rights are validated by comparing the medication order or MAR [Medication Administration Record], the medication label(s) (including pharmacy label and manufacturer label when applicable)...Any questions regarding the medication should be resolved with the prescriber or other staff involved (ex: pharmacy etc.) prior to administration...DOCUMENTATION...Medications
...are documented on the MAR or a procedural document...the MAR should include the following information...Dose...Person that administered..."
The hospital failed to ensure the individual administering the medication verified the medication order, failed to ensure the correct dose, failed to ensure labels were affixed to the syringe prior to use, failed to ensure the medication was appropriate for Patient #1's weight, and failed to ensure the nurse documented in the MAR the dose that Patient #1 received.

Refer to A 145.
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on standards of practice, policies and procedures, observation and interviews, the hospital failed to ensue the Pharmaceutical services implemented procedures to minimize the risk of medication errors for 1 of 3 (Patient #1) who received a fatal dose of Esmolol based on the hospital Pharmacist's recommendation.

The failure of the hospital to ensure the Pharmaceutical services practiced in accordance with accepted professional principles resulted in a fatal medication error for Patient #1 who received a 400% overdose of Esmolol and placed all patients in a SERIOUS and IMMEDIATE THREAT and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death.

The findings included:

1. The hospital failed to ensure the Pharmaceutical services calculated and dispensed the correct amount of the drug Esmolol which resulted in the death of Patient #1.
Refer to A 491.
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on standards of practice, document review, medical record review and interview, the hospital failed to ensure Pharmacists correctly calculated a dose of medication based on a verbal order, failed to ensure a written order was completed and failed to label the medication bag and syringes pertaining to the preparation and administration of a medication for 1 of 3 (Patient #1) patients reviewed that received Esmolol (A class II antiarrhythmic - an extremely short acting antiarrhythmic medication used for the management of hypertension and tachycardia).

The failure of the hospital to ensure pharmacists correctly calculated a verbal order for the medication Esmolol, failure to obtain a written physician order for the Esmolol and failure to provide the medical and nursing staff with adequate information regarding the administration and dose of Esmolol resulted in a fatal medication error for Patient #1 and placed all patients in a SERIOUS and IMMEDIATE THREAT of their health and safety and placed them in IMMEDIATE JEOPARDY for risk of serious injuries and/or death.

The findings included:

1. Medical record review for Patient #1 revealed the patient was admitted to the hospital Pediatric Intensive Care Unit (PICU) on 6/10/19 with diagnoses that included [DIAGNOSES REDACTED][DIAGNOSES REDACTED] (a rare disorder that causes blood vessel inflammation throughout the body), [DIAGNOSES REDACTED] Obstructive [DIAGNOSES REDACTED], (the heart muscle becomes thick and makes it harder for the heart to pump blood) and [DIAGNOSES REDACTED] (the blood takes longer to clot). The patient's weight was 30 kilograms (kg).

The Risk Manager confirmed any patient weighing less than 50 kg kilograms was treated as a pediatric patient regardless of the patient's chronological age.

On 7/27/19 at 5:13 PM, Physician #1 and Pharmacist #1 were in the patient's room during a patient procedure. After the procedure had been successfully performed, the patient's heart rate was noted to be 140 beats per minute. Physician #1 questioned Pharmacist #1 what would be the bolus dose of Esmolol to be given to Patient #1 to decrease the patient's heart rate.

Pharmacist #1 went to the hospital pharmacy and brought a bag of Esmolol to the patient's room. The Pharmacist told the Physician based on the patient's weight of 30 kg, the patient would need 3000 micrograms (mcg) of the Esmolol bag. The bag of Esmolol that was brought to the patient's room by the Pharmacist was labeled 2000 milligrams per 100 ml. RN #2 and RN #3 who were in the patient's room, drew 2 syringes of Esmolol from the 2000 mg per 100 ml bag. There was 60 ml in one syringe and 40 ml in the 2nd syringe. The Esmolol bag was empty.

At 5:18 PM, RN #1 who was also in the patient's room, took the 60 ml syringe of Esmolol and asked Pharmacist #1 if the entire 60 ml should be administered to the patient and Pharmacist #1 stated "yes".

At 5:21 PM, three minutes following the administration of the 60 ml bolus of Esmolol, Patient #1's heart stopped beating and the patient stopped breathing.

Attempts to resuscitate (revive the patient's heart rate and breathing) Patient #1 were unsuccessful and the patient was pronounced dead on 7/27/19 at 5:26 PM.

Surveyor observation of the Esmolol bag that had been used to draw-up and administer the 60 ml bolus of Esmolol to Patient #1 revealed the bag was labeled "2000 mg/100 ml".
Patient #1 had been administered a fatal dose of Esmolol totaling 1,200 mg (400 mg/kg).
The patient should have received 0.15 ml of Esmolol instead of the 60 ml of Esmolol the Pharmacists instructed the RN to administer.

In an interview on 8/13/19 at 10:05 AM with Physician #1 the physician stated, "...The Nurse Practitioner [NP] was the first one to question the dose [of Esmolol]...I went to the pharmacy and spoke to [named Pharmacist #1 and #3]. I asked did we give too much Esmolol. Somehow we very quickly realized the bag was dosed in milligrams not in micrograms. Pharmacist #1 said she read it as micrograms".
Micrograms (mcg) would be a smaller dose than milligrams (mg).

During a telephone interview on 8/14/19 at 2:36 PM in the hospital's Risk office RN #1 stated he asked Pharmacist #1 and Physician #1 if he should give the whole 60 ml because it seemed like a lot.
RN #1 stated that the pharmacist and the physician looked at each other and the pharmacist stated, "Yes, the whole thing."

During an interview on 8/13/19 at 3:38 PM in the hospital's Risk office Pharmacist #3 was asked what happened with Patient #1 and the Esmolol bolus and the Pharmacist stated, "Pharmacist #1 came down [to the pharmacy] and said [Named Physician #4] had requested a bolus of Esmolol...Pharmacist #2 pulled [looked up] Esmolol in the computer and it said the loading or bolus dose was between 100 and 200 mcg/kg. We went with 100 [mcg/kg] and calculated 3,000 mcg, her weight was around 30 kg..."
Pharmacist #3 was asked if he discussed the volume and he stated, "we did not specifically discuss the volume. We discussed the dose. They left and went back to the room. Next thing [Named Pharmacist #2] said to me was [Named Pharmacist #1] needs you now...[Named Pharmacist #1] said to me - I think we gave the wrong dose. I asked her how much did you give. She stated about 50 ccs [ml] were given...maybe 5 minutes later...when we got back to the pharmacy we re-did the math. Patient #1 had received 333% too much...The concentration was not right I assumed...I heard 50 ccs [ml] went in."

During an interview on 8/14/19 at 12:03 PM in the hospital's Risk office Pharmacist #1 was asked to share her involvement with Patient #1 and the Esmolol. Pharmacist #1 stated that she looked at the bag of Esmolol after she walked into Patient #1's room and thought it read "2,000 mcg/100 mL".
Pharmacist #1 stated, "...I had never done a bolus with Esmolol before. I don't know that I have done an infusion for Esmolol. It's not super common."
Pharmacist #1 stated after the Esmolol had been administered to Patient #1 and after the patient's heart rate had stopped, she asked to see the Esmolol bag. Pharmacist #1 stated, "At that point I thought the bag was in micrograms, but I needed to double check it".
Pharmacist #1 was asked if she had looked at the bag a second time would she have noticed the concentration and she stated, "I don't think looking at the bag a second time would have changed anything. We all were unfamiliar with the dosing from the start."

2. Review of the American Society of Hospital Pharmacy (ASHP) Guidelines: Minimum Standard for Pharmacies in Hospitals revealed, "No medication should be administered to a patient unless medical and nursing personnel have been provided with adequate information about, and are familiar with, its therapeutic use, method of administration, potential adverse effects, and dosage...A direct copy of the prescriber's order, either hard copy (including facsimile) or prescriber-entered electronic transmission (preferred method), shall be received by the pharmacist. Oral orders should be avoided to the extent possible....

The hospital Pharmacists failed to provide medical and nursing personnel adequate information about the drug Esmolol and failed to obtain a direct physician's order for the Esmolol.

Refer to A 145.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on standards of practice, review of hospital policies and procedures, document review, medical record review, observation and interview, the hospital neglected to ensure patients' rights were protected by implementing measures to mitigate risks of potential fatal medication errors to patients receiving care in the hospital.

The failure of the hospital to mitigate risks associated with medication administration and ensure all patients received the necessary care and services to prevent physical harm placed all patients in a SERIOUS and IMMEDIATE THREAT and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death.

The findings included:

1. The hospital failed to ensure all staff who were involved with medication administration, followed standards of practice and policies and procedures related to medication administration in order to ensure each patient received the correct dosage of medication.
Refer to A 145.