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Based on interview and record review, the facility failed to ensure:

1. An order for a solution was transcribed and verified with the physician in accordance with the facility's policy and procedure, for one sampled patient (Patient 1), when Physician 1's verbal order for three bags of a tumescent solution (a very dilute solution of local anesthetic [lidocaine, medication to prevent pain] combined with epinephrine [a medication which could cause the narrowing of the blood vessels and used for emergency medical treatment] to Registered Nurse (RN) 1 was incorrectly entered on the electronic health record. The solution containing the incorrect amount of medication was prepared by the pharmacy, sent to the operating room, and was administered to Patient 1. (A 398); and

2. Medication was administered in accordance with the facility's policy and procedure (P&P), for one sampled patient (Patient 1), when three of the five tumescent bag solutions were not verified (process of checking the medication label against the physician's order on the electronic health record) by RN 1 with the physician prior to the administration of the medication to Patient 1. (A405).

The cumulative effect of these failures resulted in patients to not be provided safe and quality care to meet their needs and had the potential for harm for patients receiving medications.

Based on interview and record review, the facility failed to ensure an order for a solution was transcribed and verified with the physician in accordance with the facility's policy and procedure, for one sampled patient (Patient 1), when Physician 1's verbal order for three bags of a tumescent solution (a highly diluted solution of local anesthetic [lidocaine] combined with epinephrine [a medication which could cause the narrowing of the blood vessels and used for emergency medical treatment] to Registered Nurse (RN) 1 was incorrectly entered on the electronic health record. The solution containing the incorrect amount of medication was prepared by the pharmacy, sent to the operating room, and was administered to Patient 1.

This failure may have contributed to the medication error which resulted in Patient 1's admission to the Intensive Care Unit, experiencing cardiogenic shock (a life-threatening condition in which the heart suddenly cannot pump enough blood to meet the body's needs), and being transferred to another acute care facility for a higher level of care.

Findings:

During an interview on March 7, 2022, at 12:01 p.m., conducted with RN 1, RN 1 stated he was the circulating nurse for Patient 1's surgery on December 21, 2021. RN 1 stated when Physician 1 started the surgery, Physician 1 gave him a verbal order for three more bags of the tumescent solution with the same dose as the first two bags he ordered.

RN 1 stated when he put in the order in Patient 1's record, he put the lidocaine dose of 35 mg into the box for the epinephrine. RN 1 stated the order he put in was epinephrine 35 mg instead of 1.5 mg.

RN 1 stated he read back the order to Physician 1. RN 1 stated Physician 1 "...ignores me...won't even acknowledge...so no use of order read back to him."

RN 1 stated he followed the dose on the surgeon's preference card (a list of the medication with dosages preferred to be ordered by the physician). RN 1 state he interchanged the doses of lidocaine and epinephrine and "free-text" the dose on physician order on the electronic health record.

RN 1 stated the pharmacist called him to verify the order and he interrupted the pharmacist and told her to just follow the previous order because he was in the middle of the surgery.

During an interview on March 8, 2022, at 11:17 a.m., conducted with Physician 4, Physician 4 stated when a verbal order was given to the RN, the RN should read back the verbal order to the physician.

Physician 4 stated she expected the RN to read back the order if a medication order needed clarification. Physician 4 stated the physician should confirm it was the correct order.

Physician 4 stated not all of the RNs in the OR read back the verbal orders.

During a concurrent interview and record review, on March 9, 2022, at 10:40 a.m., conducted with Nurse Manager (NM) 1, Patient 1's record was reviewed. The "H&P (History and Physical)," indicated Patient 1 was admitted to the facility on December 21, 2021, for possible rupture of left breast implant (an artificial device surgically put in the breast to change its size, contour, and/or shape).

Further review of the record indicated the physician agreed to Patient 1's request for the removal and replacement of breast silicone implants, and liposuction (a type of fat-removal procedure used in plastic surgery).

Patient 1's "Order History," dated December 20, 2021, at 8:09 p.m., indicated, "...Lidocaine (medication for pain prevention)...10 mg/ml (milligram per milliliter, units of measurement) 1% (one percent) 35 ml, Epinephrine (a medication which could cause narrowing of blood vessels and used for emergency medical treatment) 1:1000 (one gram [unit of measurement] in 1000 ml of fluids) in sodium chloride 0.9% (sterile salt solution) 1000 ml infiltration solution ...1.5 mg in sodium chloride 0.9% (sterile salt solution) 1000 ml infiltration (the IV fluid or medication enters the surrounding tissue)...Ordering Mode: Transcribed from paper (copied from paper; a method of putting in a physician's order)..."

Patient 1's "Order History," dated December 21, 2021, at 8:23 a.m., indicated, "...Lidocaine...10 mg/ml 1% 10 ml, Epinephrine 1:1000...35 mg in LR (a kind of fluid which could be administered through the veins) 1000 ml infiltration (a 23.33-fold increase in the amount of epinephrine in each of the three bags compared to the tumescent solution ordered by the physician on December 20, 2021)...Ordering Mode: Transcribed from paper..."

Patient 1's "MAR (Medication Administration Record)," indicated, "...Documented by (name of RN 1)...Lidocaine...10 mg/ml 1% 10 ml, Epinephrine 1:1000...35 mg in LR 1000 ml infiltration... given...date:12/21/21 (December 21, 2021)...time: 1013 (10:13 a.m.)...comment: a total of 3 bags given...route: infiltration...site: surgical site...documented for (name of Physician 1)..."

Patient 1's "Op (Operating) Note," dated December 21, 2021, authored by Physician 1, indicated, "...Procedures: Breast implant removal...Breast augmentation (a surgical procedure to increase breast size)...liposuction (a fat-removal procedure used in plastic surgery)...

Addendum...At the beginning of the case, two bags of Tumescent were correctly ordered and dispensed by the pharmacy prior to starting the case according to the correct formula placed in my preference card (a list indicating the specific tools, supplies, room set-up, and medications the surgeon preferred to use for a particular type of surgical case) (which was also printed out and placed in plain site for visual confirmation)...Then, upon request of 3 (three) additional bags of Tumescent formulated EXACTLY the same as per my preference card, and as per the 2 (two) bags we have in the room. Circulating RN (nurse who would make the preparation for an operation and would continually monitor the patient and the staff during the procedure) placed an incorrect order with the wrong formula placing 35 mg of epinephrine in 1 L (liter) of Lactated Ringer's (LR, IV fluid) instead of the usual 1.5 mg with 35 ml of Lidocaine 1% and this was dispensed by the pharmacy, and then upon receipt into the operating room, it was confirmed to me that these were the tumescent bags received from the pharmacy as per my order. I had no reason to think otherwise, and thus this fluid mixture was then injected into the patient..."

Patient 1's "Discharge Summary," dated December 22, 2021, indicated, "...(Name of Patient 1)...who presented with acute respiratory failure with hypoxia (an absence of enough oxygen in the tissue to sustain bodily functions) after a breast implant repair...When the patient (Patient 1) was being extubated her blood pressure rose to a systolic above 190 (normal systolic blood pressure: 120 or below). She became hypoxic (blood having low amount of oxygen)...and required re-intubation (placement of a flexible plastic tube into the airway to help with breathing)...Cardiology (a physician who specialized in treating diseases of the heart) immediately consulted and recommended cardiac catheterization (a procedure in which a thin, flexible tube would be guided through a blood vessel to the heart to diagnose or treat certain heart condition) for possible etiology (cause) of patient's cardiogenic shock (life-threatening condition in which the heart could not pump enough blood to meet the body's needs)...Patient to be transferred to (name of another acute care facility) with a referral for ECMO (Extracorporeal membrane oxygenation, a technique of providing prolonged cardiac and respiratory support to a person whose heart and lungs were unable to provide the adequate amount of blood and oxygen to sustain life)...Upon further review a high-dose of epinephrine inadvertently given in the OR (operating room)..."

NM 1 stated the tumescent solution ordered on December 21, 2021, was entered by RN 1 as "transcribed from paper" instead of "verbal order."

NM 1 stated when the medication was ordered as "transcribed from paper", the order would not go to the physician's inbox which would have allowed the physician to review the order and a co-signature by the physician would not be required.

NM 1 stated there was no documentation the verbal order was read back to the physician.

NM 1 stated a verbal order would have a "Read-back (process of the nursing staff to read the order back to the physician for verification)." NM 1 stated if the order for the tumescent solution was read back to the physician, the medication error (increased amount of epinephrine in the solution) would have been noticed sooner rather than a day after the surgery was completed.

During a review of the facility's P&P titled, "Medication(s); Prescribing And Dispensing," revised on October 26, 2020, the P&P indicated, "...The order will be read back to physician and noted..."V.O.R.B." (verbal order read back) in the medical record...Medication orders should include...Dosage...For questions arising from a medication order...the pharmacist may write a clarification order after contacting the ordering physician..."

Based on interview and record review, the facility failed to ensure medication was administered in accordance with the facility's policy and procedure (P&P), for one sampled patient (Patient 1), when three of the five tumescent bag solutions (a very dilute solution of local anesthetic [lidocaine] combined with epinephrine [a medication which could cause the narrowing of blood vessels and used for emergency medical treatment] were not verified (process of checking the medication label against the physician's order on the electronic health record) by Registered Nurse (RN) 1 with the physician prior to the administration of the medication to Patient 1.

This failure may have contributed to the medication error which resulted in Patient 1's admission to the Intensive Care Unit, experiencing cardiogenic shock (a life-threatening condition in which the heart suddenly cannot pump enough blood to meet the body's needs), and being transferred to another acute care facility for a higher level of care.

Findings:

During an interview on March 7, 2022, at 12:01 p.m., conducted with RN 1, RN 1 stated he was the circulating nurse for Patient 1's surgery on December 21, 2021. RN 1 stated when Physician 1 started the surgery, Physician 1 gave him a verbal order for three more bags of the tumescent solution with the same dose as the first two bags he ordered.

RN 1 stated when he put in the order in Patient 1's record, he put the lidocaine dose of 35 mg into the box for the epinephrine. RN 1 stated the order he put in was epinephrine 35 mg instead of 1.5 mg.

RN 1 stated the pharmacist called him to verify the order and he interrupted the pharmacist and told her to just follow the previous order because he was in the middle of the surgery.

RN 1 stated he was very busy attending to the surgeon's requests during the surgery when Pharmacist 1 called him to verify the medication order. RN 1 stated he interrupted Pharmacist 1 and told the pharmacist, "Just follow previous order."

RN 1 stated the process for medication administration during surgery was for the RN to verify each of the patient's medications by looking at the label and comparing the medication label to the physician's order prior to giving the medication to the physician.

During a concurrent interview and record review, on March 9, 2022, at 10:40 a.m., conducted with Nurse Manager (NM) 1, Patient 1's record was reviewed. The "H&P (History and Physical)," indicated Patient 1 was admitted to the facility on December 21, 2021, for possible rupture of left breast implant (an artificial device surgically put in the breast to change its size, contour, and/or shape).

Further review of the record indicated the physician agreed to Patient 1's request for the removal and replacement of breast silicone implants (breast implant pre-filled with colorless oil like substance), and liposuction (a type of fat-removal procedure used in plastic surgery).

Patient 1's "Order History," dated December 20, 2021, at 8:09 p.m., indicated, "...Lidocaine (medication for pain prevention)...10 mg/ml (milligram per milliliter, units of measurement) 1% (one percent) 35 ml, Epinephrine (a medication which could cause narrowing of blood vessels and used for emergency medical treatment) 1:1000 (one gram [unit of measurement] in 1000 ml of fluids) in sodium chloride 0.9% (sterile salt solution) 1000 ml infiltration solution ...1.5 mg in sodium chloride 0.9% (sterile salt solution) 1000 ml infiltration (the IV fluid or medication enters the surrounding tissue)...Ordering Mode: Transcribed from paper (copied from paper; a method of putting in a physician's order)..."

Patient 1's "Order History," dated December 21, 2021, at 8:23 a.m., indicated, "...Lidocaine...10 mg/ml 1% 10 ml, Epinephrine 1:1000...35 mg in LR (a kind of fluid which could be administered through the veins) 1000 ml infiltration (a 23.33-fold increase in the amount of epinephrine in each of the three bags compared to the tumescent solution ordered by the physician on December 20, 2021)...Ordering Mode: Transcribed from paper..."

Patient 1's "MAR (Medication Administration Record)," indicated, "...Documented by (name of RN 1)...Lidocaine...10 mg/ml 1% 10 ml, Epinephrine 1:1000...35 mg in LR 1000 ml infiltration... given...date:12/21/21 (December 21, 2021)...time: 1013 (10:13 a.m.)...comment: a total of 3 bags given...route: infiltration...site: surgical site...documented for (name of Physician 1)..."

Patient 1's "Op (Operating) Note," dated December 21, 2021, authored by Physician 1, indicated, "...Procedures: Breast implant removal...Breast augmentation (a surgical procedure to increase breast size)...liposuction...

Addendum...At the beginning of the case, two bags of Tumescent were correctly ordered and dispensed by the pharmacy prior to starting the case according to the correct formula placed in my preference card...Then, upon request of 3 (three) additional bags of Tumescent formulated exactly the same as per my preference card (a list indicating the specific tools, supplies, room set-up, and medications the surgeon preferred to use for a particular type of surgical case), and as per the 2 (two) bags we have in the room. Circulating RN (nurse who would make the preparation for an operation and would continually monitor the patient and the staff during the procedure) placed an incorrect order with the wrong formula placing 35 mg of epinephrine in 1 L (liter) of Lactated Ringer's (LR, IV fluid) instead of the usual 1.5 mg with 35 ml of Lidocaine 1% and this was dispensed by the pharmacy, and then upon receipt into the operating room, it was confirmed to me that these were the tumescent bags received from the pharmacy as per my order. I had no reason to think otherwise, and thus this fluid mixture was then injected into the patient..."

Patient 1's "Discharge Summary," dated December 22, 2021, indicated, "...(Name of Patient 1)...who presented with acute respiratory failure with hypoxia (an absence of enough oxygen in the tissue to sustain bodily functions) after a breast implant repair...When the patient (Patient 1) was being extubated her blood pressure rose to a systolic above 190 (normal systolic blood pressure: 120 or below). She became hypoxic (blood having low amount of oxygen)...and required re-intubation (placement of a flexible plastic tube into the airway to help with breathing)...Cardiology (a physician who specialized in treating diseases of the heart) immediately consulted and recommended cardiac catheterization (a procedure in which a thin, flexible tube would be guided through a blood vessel to the heart to diagnose or treat certain heart condition) for possible etiology (cause) of patient's cardiogenic shock (life-threatening condition in which the heart could not pump enough blood to meet the body's needs)...Patient to be transferred to (name of another acute care facility) with a referral for ECMO (Extracorporeal membrane oxygenation, a technique of providing prolonged cardiac and respiratory support to a person whose heart and lungs were unable to provide the adequate amount of blood and oxygen to sustain life)...Upon further review a high-dose of epinephrine inadvertently given in the OR (operating room)..."

NM 1 stated during the surgery when a medication was ordered for a patient, the RN would prepare and verify the medication. The RN would then give the medication to the surgeon, and the surgeon would administer the medication to the patient.

NM 1 stated the RN who prepared and verified the medication bag label against the physician's order on the Medication Administration Record.

NM 1 stated each of Patient 1's tumescent solution bags should have been prepared and verified individually by RN 1.

NM 1 stated there was no documentation three of the five tumescent solution bags were verified by RN 1 with the physician.

NM 1 stated if RN 1 verified each of the tumescent solution bags, RN 1 would have noticed the incorrect dose of Epinephrine 35 mg in each of the three bags.

NM 1 stated there was no barcode scanning of medications in the OR. NM 1 stated the RNs would follow the same steps of verifying the medication manually instead of using the bar code scanning.

During a review of the facility's P&P titled, "Medication and Intravenous Fluids Administration Documentation Standards," revised on May 12, 2021, the P&P indicated, "...All medication administrations will be accomplished by scanning the medication and patient bar codes and validating the six patient rights - right route, med (medication), patient, time, dose and right documentation..."

Based on interview and record review, the facility failed to ensure a facility policy and procedure was developed for the use of intraoperative (during surgery) protocol orders (a set of orders for certain surgical procedures approved by the facility) on a physician's preference card (a list of preferences, including medications with preferred doses) entered by registered nurses (RNs), for two patients (Patient 1 and 9).

This failure resulted in delayed identification of Patient 1's medication error which resulted in Patient 1's admission to the Intensive Care Unit, experiencing cardiogenic shock (a life-threatening condition in which the heart suddenly cannot pump enough blood to meet the body's needs), and being transferred to another acute care facility for a higher level of care.

In addition, this failure resulted in medication errors to not be reviewed and authenticated (signed) by the physician, increasing the risk for medication errors and unsafe patient care for Patient 9 and other patients receiving medications included in the protocol orders.

Findings:

1. During a concurrent interview and record review, on March 9, 2022, at 10:40 a.m., conducted with Nurse Manager (NM) 1, Patient 1's record was reviewed. The "H&P (History and Physical)," dated December 21, 2021, indicated Patient 1 was admitted to the facility on December 21, 2021, for possible rupture of left breast implant (an artificial device surgically put in the breast to change its size, contour, and/or shape).

Further review of the record indicated the physician agreed to Patient 1's request for the removal and replacement of breast silicone implants (breast implant pre-filled with colorless oil like substance), and liposuction (a type of fat-removal procedure used in plastic surgery).

Patient 1's "Order History," dated December 20, 2021, at 8:09 p.m., indicated, "...Lidocaine (medication for pain prevention)...10 mg/ml (milligram per milliliter, units of measurement) 1% (one percent) 35 ml, Epinephrine (a medication which could cause narrowing of blood vessels and used for emergency medical treatment) 1:1000 (one gram [unit of measurement] in 1000 ml of fluids) in sodium chloride 0.9% (sterile salt solution) 1000 ml infiltration solution ...1.5 mg in sodium chloride 0.9% (sterile salt solution) 1000 ml infiltration (the IV fluid or medication enters the surrounding tissue)...Ordering Mode: Transcribed from paper (copied from paper; a method of putting in a physician's order)..."

Patient 1's "Order History," dated December 21, 2021, at 8:23 a.m., indicated, "...Lidocaine...10 mg/ml 1% 10 ml, Epinephrine 1:1000...35 mg in LR (a kind of fluid which could be administered through the veins) 1000 ml infiltration (a 23.33-fold increase in the amount of epinephrine in each of the three bags compared to the tumescent solution ordered by the physician on December 20, 2021)...Ordering Mode: Transcribed from paper..."

Patient 1's "MAR (Medication Administration Record)," indicated, "...Documented by (name of RN 1)...Lidocaine...10 mg/ml 1% 10 ml, Epinephrine 1:1000...35 mg in LR 1000 ml infiltration... given...date:12/21/21 (December 21, 2021)...time: 1013 (10:13 a.m.)...comment: a total of 3 bags given...route: infiltration...site: surgical site...documented for (name of Physician 1)..."

Patient 1's "Op (Operating) Note," dated December 21, 2021, authored by Physician 1, indicated, "...Procedures: Breast implant removal...Breast augmentation (a surgical procedure to increase breast size)...liposuction (a fat-removal procedure used in plastic surgery)...

Addendum: At the beginning of the case, two bags of Tumescent were correctly ordered and dispensed by the pharmacy prior to starting the case according to the correct formula placed in my preference card (which was also printed out and placed in plain site for visual confirmation). I visually confirmed these two bags with the team members including the circulating RN (nurse who would make the preparation for an operation and would continually monitor the patient and the staff during the procedure). Then, upon request of 3 (three) Additional bags of tumescent formulated EXACTLY the same as per my preference card, and as per the 2 (two) bags we have in the room. Circulating RN placed an incorrect order with the wrong formula placing 35 mg of epinephrine in 1 L of lactated Ringer's instead of the usual 1.5 mg with 35 mL of lidocaine 1% (one percent), and this was dispensed by the pharmacy, and then upon receipt into the operating room, it was confirmed to me that these were the tumescent bags received from the pharmacy as per my order, I had no reason to think otherwise, and thus this fluid mixture was then injected into the patient..."

Patient 1's "Discharge Summary," dated December 22, 2021, indicated, "...(Name of Patient 1)...who presented with acute respiratory failure with hypoxia (an absence of enough oxygen in the tissue to sustain bodily functions) after a breast implant repair...When the patient (Patient 1) was being extubated (breathing tube was removed), her blood pressure rose to a systolic above 190 (normal systolic blood pressure: 120 or below). She became hypoxic (blood having low amount of oxygen)...and required re-intubation (placement of a flexible plastic tube into the airway to help with breathing)...Cardiology (a physician who specialized in treating diseases of the heart) immediately consulted and recommended cardiac catheterization (a procedure in which a thin, flexible tube would be guided through a blood vessel to the heart to diagnose or treat certain heart condition) for possible etiology (cause) of patient's cardiogenic shock (life-threatening condition in which the heart could not pump enough blood to meet the body's needs)...Patient to be transferred to (name of another acute care facility) with a referral for ECMO (Extracorporeal membrane oxygenation, a technique of providing prolonged cardiac and respiratory support to a person whose heart and lungs were unable to provide the adequate amount of blood and oxygen to sustain life)...Upon further review a high-dose of epinephrine inadvertently given in the OR (operating room)..."

There was no documented evidence the tumescent solution ordered for Patient 1 on December 20 and 21, 2021, was authenticated by Physician 1.

NM 1 stated the tumescent solution ordered on December 20, 2021, was entered by the RN from Physician 1's preference card as "transcribed from paper" instead of "per protocol" orders. NM 1 stated the tumescent solution ordered on December 21, 2021, was entered by RN 1 as "transcribed from paper" instead of "verbal order."

NM 1 stated when the medication was ordered as "transcribed from paper", the order would not go to the physician's inbox which would have allowed the physician to review the order and a co-signature by the physician would not be required.

NM 1 stated a verbal order would have a "Read-back (process of the nursing staff to read the order back to the physician for verification)." NM 1 stated if the order for the tumescent solution was read back to the physician, the medication error (increased amount of epinephrine in the solution) would have been noticed sooner rather than a day after the surgery was completed.

NM 1 stated the tumescent solution ordered by RN 1 for Patient 1 was not authenticated by Physician 1 and the medication error was not identified until the next day (December 22, 2021) after a root cause analysis (a method of problem solving used for identifying the root cause of faults or problems) was conducted.

During an interview conducted with the Vice-President Chief Quality Officer (VP-CQO) on March 10, 2022, ar 12:23, p.m., the VP-CQO stated the facility did not have a policy and procedure on protocol orders being ordered by the nursing staff.

2. During a concurrent interview and record review, on March 9, 2022, at 11:15 a.m., conducted with NM 1, Patient 9's record was reviewed. Patient 9 was admitted to the facility on March 8, 2022, for the surgical procedure of an anterior cervical discectomy fusion (neck surgery involving removing damaged disks [rubbery pads between the bones of the spinal column] to relieve spinal cord pressure).

The physician's order, entered by a RN on March 7, 2022, indicated, "Ancef (antibiotic) 2 g (two grams) in sodium chloride 1,000 ml...as needed for surgical irrigation (the process of washing out an organ or wound with a continuous flow of water or medication)...Ordering mode: Transcribed from paper..."

Patient 9's Medication Administration Record (MAR) indicated the above prescribed medication was administered on March 8, 2022, at 8:53 a.m.

NM 1 stated there was no documentation indicating Patient 9's Ancef order for surgical irrigation was cosigned or authenticated by the physician.

NM 1 stated the Ancef order for surgical irrigation was entered by the RN from the physician's preference card (set of instructions for positioning, medications, supplies, and equipment required for a specific procedure) as "transcribed from paper" instead of "per protocol." NM 1 further stated when the medication was ordered as "transcribed from paper," a review and co-signature by the physician would not be required.

During an interview on March 10, 2022, at 11:56 a.m., conducted with the Chief Medical Officer (CMO), the CMO stated RNs enter medication orders the night before the patients' surgeries using the physician's preference card.

The CMO stated these medication orders from the physician's preference card should be entered as protocol orders so the physician can cosign and authenticate.

During an interview on March 10, 2022, at 12:10 p.m., conducted with the Vice President and Chief Quality Officer (VPCQO), the VPCQO stated the facility had not developed a P& P to address the process of ordering and authenticating protocol orders. The VPCQO stated the facility did not have a P&P regarding the process of entering medication orders from the physician preference cards.

Based on interviews and record review, the facility failed to provide pharmaceutical services that meet the needs of the patients as evidenced by the facility's failure to ensure medication orders were reviewed for appropriateness by pharmacists to prevent medication errors prior to dispensing and administration of medications, when a medication order for tumescent solutions (diluted solution) containing lidocaine and epinephrine were inaccurately entered in the electronic health record system, verified, and dispensed by pharmacists, resulting in Patient 1 receiving more than 20 times the amount intended by the prescriber. (A500)

The cumulative effect of the systemic problem resulted in the hospital's failure to ensure the provision of pharmaceutical services in a safe environment that met the needs of the patients.

Based on interview and record review, the facility failed to ensure medication orders were reviewed for appropriateness by pharmacists to prevent medication errors prior to dispensing and administration of medications, when a medication order for tumescent solutions (solution with small amount of epinephrine [a medication which could cause narrowing of blood vessels and used for emergency medical treatment] and lidocaine [medication for pain prevention] mixed with fluids) were inaccurately entered in the electronic health record system, verified, and dispensed by pharmacists, resulting in Patient 1 receiving three bags of solution containing more than 20 times the amount of epinephrine intended by the prescriber.

This failure resulted in Patient 1 receiving critical care management to stabilize the high blood pressure, maintain breathing via mechanical device, and treat cardiogenic shock (a life-threatening condition in which the heart suddenly cannot pump enough blood to meet the body's needs). This failure had the potential for harm for other patients receiving tumescent solutions containing dangerous drugs.

Findings:

On March 7, 2022, Patient 1 's medical record was reviewed and the following were noted:

1. The physician order on December 20, 2021, for two infiltration solution bags containing 35 ml (milliliter, unit of measure) of lidocaine 10 mg/ml (1%, one percent), 1.5 mg (milligram, unit of measurement) of epinephrine 1:1000 (one gram [unit of measurement] in 1000 ml of fluids) in sodium chloride 0.9% (sterile salt solution) 1000 ml infiltration solution, entered by Registered Nurse (RN) 10 in the electronic health record, authorized by Physician 1, and verified by Pharmacist 5.

2. The physician order, dated December 21, 2021, at 8:30 a.m., for three additional infiltration solution bags containing 10 ml lidocaine 1%, 35 mg of epinephrine 1:1000 in lactated ringer (a kind of fluid which could be administered through the veins) 1000 ml infiltration solution, entered by RN 1 on the electronic health record, authorized by Physician 1, and verified by Pharmacist 1. It was noted lidocaine 1% contained in this ordered batch of tumescent solutions decreased from 35 ml to 10 ml and epinephrine 1:1000 increased from 1.5 mg to 35 mg (a 23.33-fold increase in the amount of epinephrine in each of the three bags compared to the tumescent solution ordered by the physician on December 20, 2021).

3. The electronic Medication Administration Record (eMAR) indicated three 1000 ml lactated ringer tumescent solutions containing 10 ml lidocaine 1% and 35 mg epinephrine 1:1000 were administered to Patient 1 on December 21, 2021, at 10:13 a.m., and two 1000 ml sodium chloride 0.9% tumescent solutions containing 35 ml lidocaine 1% and 1.5 mg epinephrine 1:1000 were administered to Patient 1 on December 21, 2022, at 10:14 a.m.

4. The Medical staff-approved preference card (a list of medications, equipment and positioning preferred by specific physicians) for cosmetic liposuction (fat-removal procedure used in plastic surgery) by Physician 1 was reviewed and it included two bags of sodium chloride 0.9% 1000 ml solutions containing 35 ml lidocaine 1% plain and 1.5 ml (1.5 mg) epinephrine 1:1000.

5. Patient 1's "H&P (History and Physical)," signed on December 21, 2021 by Physician 1, indicated Patient 1 had a chief complaint of possible rupture of left breast implant and was admitted for possible bilateral capsulectomy (removing of the scar tissues surrounding breast implants), capsulotomy (partial removal of the scar tissues surrounding breast implants), replacement with smooth silicone implants, cosmetic liposuction, and possible fat grafting (surgical procedure in which fat would be transferred from one part of the body to another).

6. The "Op Note (Operative Note) Addendum," dated December 22, 2021, authored by Physician 1 indicated the surgical procedure was started on December 21, 2021, at 8:23 a.m., to perform breast implant removal, breast capsulotomy, and removal of retained foreign body on left breast, bilateral breast augmentation, silicone implant insertion cosmetic, liposuction trunk cosmetic (a type of liposuction), and fat graft transfer from trunk to bilateral breast.

In addition, the "Op Note" included, "...The procedure started on left left [sic.] breast...Tumescent was then infiltrated in the inferior lateral tissues of the chest, and throughout the left side of the abdomen and in the pillars of the breast, and allowed to sit there during closure of the breast to allow for adequate vasoconstriction (narrowing of the blood vessels)...Liposuction was performed of the lateral chest rolls...Attention was then paid a right breast [sic.], as tumescent was infiltrated into the lateral chest roll, inferior breast tissues, and right-side of the abdomen, this was allowed to settle and allowed for vasoconstriction while performing the right-sided breast surgery...Liposuction was performed at this to the right lateral chest wall and abdominal wall...During this time - anesthesia noted spike in blood pressure, however, there was no further tumescent that would be infused...About 100 ml of fat was reinjected into the upper medial breast tissue ...Patient was then extubated (breathing tube was removed), placed in abdominal binder (a wide compression belt used for support) over over [sic.] 5 mm foam and placed into overall a brassiere. Patient was noted to have difficulty breathing by the anesthesiologist and was then reintubated (breathing tube was placed again in the airway to allow assisted breathing). Patient was transferred to the ICU (intensive care unit, hospital unit for care of patients with life-threatening illnesses needing critical medical care) intubated. Total tumescent infiltrated was 4.5 L (four and a half liters, unit of measurement). Total aspirate (matter removed by suction) 2100 mL, total supernatant (liquid above a solid matter) 1100ml...

Addendum: At the beginning of the case, two bags of Tumescent were correctly ordered and dispensed by the pharmacy prior to starting the case according to the correct formula placed in my preference card (which was also printed out and placed in plain site for visual confirmation). I visually confirmed these two bags with the team members including the circulating RN (nurse who would make the preparation for an operation and would continually monitor the patient and the staff during the procedure). Then, upon request of 3 (three) Additional bags of tumescent formulated EXACTLY the same as per my preference card, and as per the 2 (two) bags we have in the room. Circulating RN placed an incorrect order with the wrong formula placing 35 mg of epinephrine in 1 L of lactated Ringer's instead of the usual 1.5 mg with 35 mL of lidocaine 1% (one percent), and this was dispensed by the pharmacy, and then upon receipt into the operating room, it was confirmed to me that these were the tumescent bags received from the pharmacy as per my order, I had no reason to think otherwise, and thus this fluid mixture was then injected into the patient subcutaneously (under the skin) as tumescent fluid. The initial 2 bags were utilized for the left side, and the latter 2.5 bags were used for the right side..."

7. The "Discharge Summary," dated December 22, 2021, indicated, " ...Patient (Patient 1) was seen today Plastic surgery (Physician 1) for a ruptured left breast implant shell (outer material around a breast implant [artificial material put in a breast to increase its size]) and tummy tuck (the removal of excess skin and fat from the abdomen), Per the surgeon, during the procedure the patient received all local anesthetic (medication to prevent pain) with lidocaine and epinephrine. Per Plastic surgery, patient received 2 L of fluid intravenously (administered in the vein) and 4 L with epinephrine tumescently (administered of the tumescent solution into the tissue during liposuction). When the patient was being extubated her blood pressure rose to a systolic above 190 (normal systolic blood pressure: 120 or below). She became hypoxic (blood having low amount of oxygen), started frothing at the mouth and required re-intubation. The anesthesiologist noted crackles (sound which could signify fluids in the lung) on lung auscultation. Patient subsequently became hypotensive (having low blood pressure) and taken to the ICU for critical care management.

Per patient 's husband, patient is healthy and otherwise did not have any home medication. He states he remembers a time when she had allergic reaction to iron (a kind of mineral). He states he does not know of any other allergy she has. This is never happened before [sic.]...He denies any cardiac history...

In the ICU patient was placed on norepinephrine (medication used in emergency to increase the rate and force of contraction of the heart) as she became hypotensive (low blood pressure). Central line and arterial (intravenous lines placed in the artery and large vein) were both placed in the ICU. Post op, Echocardiogram (ultrasound of the heart) showed ejection fraction (measurement of how much blood would leave the heart with each beat) of 32% (normal would be 55% to 75%) with a high sensitivity of troponin (a type of protein found in heart muscles which could be released into the blood when the heart muscle is damaged; normal level of 0-0.04 ng/ml [nanogram per milliliter, unit of measurement]; a high level could signify heart attack)) of 2885. Cardiology (medical practice which specialized with diseases of the heart) was immediately consulted and recommended cardiac catheterization (a procedure in which a thin, flexible tube would be guided through a blood vessel to the heart to diagnose or treat certain heart conditions) for possible etiology (cause) of patient 's cardiogenic shock (a life-threatening condition in which the heart could not pump enough blood to meet the body's needs). Subsequent troponin was 4535...Cardiology placed Impella device (device placed in the left venricle [one of the chambers of the heart] to help the heart pump blood into the body) to help with perfusion (delivery of blood into the small blood vessels) given severe cardiogenic shock.

Additionally, patient was found to be in DKA (diabetic ketoacidosis, serious complication of diabetes [abnormal blood sugar] which could occur when the body produced high levels of blood acids called ketones) with no previous diabetic history. Patient was started on insulin (medication for diabetes) protocol...Patient has required both dobutamine and norepinephrine (medications used to support blood pressure) to maintain adequate blood pressure...

Patient to be transferred to (name of other acute care facility) with a referral for ECMO (extracorporeal membrane oxygenation, a machine that replaces the function of heart and lung in critically ill patients)...

Upon further review, a high-dose of epinephrine inadvertently given in the OR (operating room) tumescently and subcutaneously (under the skin)..."

In an interview on March 7, 2022, at 11:20 a.m., conducted with Pharmacist 1 who reviewed and verified the tumescent solution ordered on December 21, 2021, Pharmacist 1 stated when Pharmacy Technician (PT) 1 questioned the doses for the tumescent solutions on December 21, 2021, she contacted RN 1 to verify the dose. Pharmacist 1 stated she documented the conversation and approved the order to be made by PT 1 after speaking to RN 1.

Pharmacist 1 stated when verifying the tumescent solution order, she was not familiar with the order, did not know what the appropriate dose ranges were for epinephrine and lidocaine in the solutions, and did not consult with any available pharmacy references.

Pharmacist 1 stated she did not know the tumescent solutions she verified contained more than 20 times the amount of epinephrine intended by the ordering physician.

Pharmacist 1 stated she was aware she could refuse to fill the order, if in her clinical judgment, the order could harm the patient.

In a concurrent interview, Pharmacist 2 stated EHR order sets for tumescent solutions did not have a hard stop (a process that would stop the prescribing, dispensing, or administering of medications which would likely be dangerous to the patient) and allowed users to free-text (staff allowed to type in answers to inquiries in the systems and forms) in the doses for epinephrine and lidocaine in the tumescent solutions.

In an interview on March 7, 2022, at 12 p.m., with RN 1, the circulating nurse who entered the second tumescent solution order for Patient 1, stated Physician 1, on December 21, 2021, ordered an additional three bags of tumescent solutions for Patient 1 and, with the help of Pharmacist 1, he was able to locate the tumescent solution build in the electronic health record system (EHR) and free-text in the doses of epinephrine and lidocaine.

RN 1 stated he told Pharmacist 1 to go by the last order when Pharmacist 1 called him later to question the tumescent solution doses he entered in the EHR on December 21, 2021.

RN 1 added Physician 1 should have planned ahead for an operation. Physician 1 did not confirm the tumescent solution when read back to him. Physician 1 did not verify the tumescent solution bags, and the other nurse spiking the tumescent bags should have verified the hanging tumescent solutions.

RN 1 further added it was his first time entering the tumescent solution order in the EHR and there should have been a hard stop to prevent errors since the EHR allowed to free-text in the doses.

In an interview on March 7, 2022, at 2:50 p.m., conducted with PT 1, PT 1 stated he consulted another technician and Pharmacist 3 about the amount of epinephrine required for the compounding (process of combining, mixing, or altering ingredients to create a medication) of the tumescent solutions because the amount of epinephrine ordered was unusually higher than he had seen before.

PT 1 stated Pharmacist 3, after talking to Pharmacist 1, brought the labels back to him indicating it was okay to compound (prepare the mixture) the solutions.

Review of the pharmacy compound log on March 7, 2022, indicated Pharmacist 4 checked the compounded tumescent solutions made by PT 1.

In an interview on March 8, 2022, at 10:15 a.m., conducted with Pharmacist 4, who performed the final check of the tumescent solutions compounded on December 21, 2021, before they were dispensed for Patient 1's procedure, stated the compounded solutions' labels were compared with the manufacturer 's labels on the medication vials and the volume of those medications used.

Pharmacist 4 did not state if the doses of lidocaine and epinephrine were checked for appropriateness, stating she could have been more proactive in reviewing the doses.

In an interview on March 8, 2022, at 11:15 a.m., conducted with Physician 4, the Chief of Plastic Surgery, Physician 4 stated prior to the dermatologist technique development and the use of the tumescent solutions, patients were bleeding out and dying. Physician 4 stated the tumescent solutions contained epinephrine to stop the bleeding and lidocaine to prevent pain.

Physician 4 stated doses of lidocaine in 1000 ml solution could be 20 ml, 70 ml, or as much as 100 ml and doses of epinephrine ranged between 1 mg and 2 mg, but no more than 2 mg per 1000 ml solution.

Physician 4 stated she had never seen a 35 mg epinephrine 1:1000 dose in 1000 ml solution and that she would never infuse that solution.

In an interview on March 9, 2022, at 9:30 a.m., conducted with Pharmacist 3, Pharmacist 3 stated the dose could not be right and brought the tumescent solution label to Pharmacist 1 who told her the dose was verified with a physician and it was what the physician wanted.

Pharmacist 3 stated Pharmacist 1 took the label and gave it to PT 1 to compound the solutions.

A review of the following undated three physicians' Preference Cards for cosmetic liposuction procedure for comparison indicated the dose of epinephrine in the tumescent solutions did not exceed 1 mg in 1000 ml solution bags:

Physician 2's cosmetic liposuction: "...Tumescent formula - to be mixed by Pharmacy 1000ml lactated ringers w/25cc (ml) of lidocaine 1% plain and Epi (Epinephrine) 1:1000 x 1cc vial (1cc vial equals 1 mg of epinephrine). May use up to three bags of Tumescent...;"

Physician 3's cosmetic liposuction: "...Tumescent Formula - 1000 ml LR (lactated ringer - injectable intravenous fluid containing electrolytes) with 30 ml 1% lidocaine, 1 ml (=1 mg) Epi 1:1000. Usually uses 2 liters for full body lipo (liposuction)...;"

Physician 4's cosmetic liposuction: "...Tumescence solution - Lidocaine 1% plain 50 ml + 1 mg/ml epi + NaCl (sodium chloride - salt) 1000 ml IV (intravenous) bag x 2 bags (For Mommy make over [set of operations to help a woman regain her body shape before pregnancy, which could include tummy tuck and liposuction] order 4 bags)..."

Review of the facility's policy and procedure titled, "Medication(s); Prescribing and Dispensing " last review, October 26, 2020, indicated:

"...When, in the professional judgment of the pharmacist, a problem exists with a medication order, the pharmacist will contact the ordering practitioner, obtain a telephone clarification order, write the order in the patient 's medical records... "

Review of the facility's policy and procedure titled, "Computer Order Entry," with the effective date of February 1, 2022, indicated:

"...Processing New Medication Orders...The pharmacist will enter or verify technician entered orders after...Review of appropriateness of the order in terms of...Medication use in the context of the patient 's clinical condition...Conforming to the approved indication for use or clinically accepted standard of practice...Dosage regimen, frequency and route of administration...

The pharmacist will contact the prescriber for any medication order that in the professional judgment of the pharmacist is inappropriate...

The order will not be entered into the computer until the pharmacist deems the order appropriate...In the event that an order is received with a problem, the pharmacist will perform an intervention to clarify the order by processing the clarification order after contacting the prescriber, or in accordance with approved EMC protocol...

If an impasse develops between the pharmacist and the prescribing physician, the pharmacist will document the events of the intervention, then...The pharmacist may process the order as written, or...The pharmacist may refuse to fill any order that is perceived to be harmful or not in the best interest of the care of the patient... "

The facility's policy and procedure titled, " Scope of Pharmacy Services, " with the effective date of February 2, 2022, indicated:

" Prescribing activities for hospital, emergency room, same day surgery, and infusion center patients...Pharmacist will review and approve of new medication orders for patients prior to medication administration to verify the order regarding appropriateness of...Conforming with the approved indication for use ...Dosage regimen, frequency and route of administration... "

Due to the failure of Pharmacy staff to readily identify the inappropriateness of the doses of epinephrine and lidocaine used in the tumescent solutions on December 21, 2021, which resulted in Patient 1 requiring critical care management and the transfer of the patient for mechanical intervention to treat cardiogenic shock, the survey team determined that an IJ (immediate jeopardy) situation existed on March 7, 2022, at 5:42 p.m., and was communicated to the hospital staff which included the Vice President for Ambulatory Division (VPAD), the Registered Nurse Quality Analyst (RNQA), the Vice President and Chief Quality Officer (VPCQO), the Administration Quality Director (AQD), and the Quality Director for Ambulatory (QDA).

On March 7, 2022, at 7:40 p.m., the facility provided an acceptable removal plan of immediate action that included the following:

"1. Suspension of Cases: Suspend all infiltrative tumescent anesthesia cases (operations using tumescent solutions to prevent pain) in the Operating Room effective 3-7-22 (March 7, 2022) until further notice. This will include a memorandum to all surgeons from the CMO (Chief Medical Officer) tonight 3-7-22 indicating all infiltrative tumescent anesthesia is suspended until further notice.

2. Nursing Workflow: Nursing orders are inactivated immediately 3-7-22 to prevent an RN from entering an infiltrative tumescent anesthesia order.

3. Pharmacist Education: the Director of Pharmacy...will ensure that all pharmacists are educated that tumescent anesthesia preparation in pharmacy is suspended immediately, 3-7-22. The CMO's general surgeon memo will also be posted in the immediate Pharmacy area. Further pharmacy education will be developed to address the clarification of tumescent orders with physicians. Pharmacist education will be documented.

4. Emergency Build: An emergent Electronic Health Record (EHR) build with a hard stop of preventing ordering of Epinephrine greater than 1.5 mg/liter will be created and implemented as soon as possible. Testing and validation of workflow will be required to implement this and will continue into 3-8-22 (March 8, 2022) until complete. An emergent Information Systems change control release of the final EHR workflow change will be implemented by the Chief Information Officer...Nursing Education will be completed as to the hard stop.

5. Plastic Surgery Section Meeting: A Plastic Surgery section meeting will be convened this week to determine standard lidocaine anesthesia dosing to accompany Epinephrine, this will be organized by the CMO...and Director of Medical Staff...Once the standard Epinephrine and lidocaine dosing is established, follow up Pharmacy and Nursing education will be completed."

On March 9, 2022, at 4:18 p.m., the implementation of the removal plan was verified onsite through observation, interview, and record review. The AQD, the QDA, and the VPCQO were notified that the immediate jeopardy was removed.