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Based on record reviews, interviews, and review of the hospital's governing body minutes, the hospital's Governing Body failed to ensure the Intensive Care Unit (ICU) operated in a responsible manner to ensure the safety of those patients receiving high risk intravenous infusion medications for 1 of 1 patient receiving Propofol. (Patient #1)

The findings are:

Cross Reference to 0063: The Governing Body failed to ensure specific patient care requirements were met for the administration of high risk intravenous infusion medications in the hospital's Intensive Care Unit receiving Propofol for 1 of 1 Patient. (Patient #1)

Based on record review and interview, the Governing Body failed to ensure specific patient care requirements were met for the administration of high risk intravenous infusion medications in the hospital's Intensive Care Unit for 1 of 1 patient receiving Propofol. (Patient #1)

The findings are:

Cross Reference to A 0392: The hospital's nursing services failed to ensure patients in the Intensive Care Unit (ICU) received assessment, monitoring, and high risk intravenous medications in a safe setting for 1 of 1 patient who received a high risk medication (Propofol) unsafely. (Patient #1)

On 01/20/2021 at 2:00 PM, review of the hospital's governing body minutes revealed the hospital's last governing body meeting was dated November 17, 2020. There was no other documentation of the governing body's involvement of the incident.

Review of the hospital's minutes, titled, "High Reliability Council Meeting Minutes" dated 01/12/2021 revealed in the section, "Clinical Risk Report", that "2 reportable safety events in November 2020 and 3 in December 2020". In the section, "Action, Evaluation", was documented "Received as Informational Only".

Review of the hospital's "Quality and Patient Safety Committee Minutes" dated 01/19/2021 revealed the same information that Clinical Risk Management documented in the "High Reliability Council Meeting Minutes" dated 01/12/2021.

On 1/20/2021 from 10:07 AM to 10:39 AM, the Clinical Risk Management Director (CRMD) revealed "Information from VERGE will be sent for nursing review for Root Cause Analysis (RCA). CRMD reported "The Root Cause Analysis (RCA) is in progress and was sent to the Board of Trustees. The CRMD reported he/she was off from 12/24/2020 through 12/27/2020 and the State Agency was notified of the patient's death on 12/30/2020. When asked about staff training since the incident on 12/24/2020, the CRMD reported Clinical Nursing ICU Director sent a memo to staff in the ICU via email and the hospital will have an article in the monthly training Topics In Patient Safety (TIPS).

Based on observations, record reviews, review of the hospital's policies and procedures, the hospital failed to ensure the patient's right to receive care in a safe setting for patients receiving medications through the intravenous infusion route for 1 of 1 patient in the hospital's Intensive Care Unit (ICU) receiving Propofol. (Patient #1)

The findings are:

Cross Reference to A 0144: The hospital failed to ensure patients in the Intensive Care Unit (ICU) received high risk intravenous medications in a safe setting for 1 of 1 patient who received a high risk medication (Propofol) without using a medication administration pump. (Patient #1)

Based on record reviews, interviews, and review of the hospital's policies and procedures, the hospital failed to ensure patients in the Intensive Care Unit (ICU) received high risk intravenous medications in a safe setting for 1 of 1 patient who received a high risk medication (Propofol) without using a medication administration pump. (Patient #1)

The findings are:

Cross Reference to A 0392: The hospital's nursing services failed to ensure patients in the Intensive Care Unit (ICU) received assessment, monitoring, and high risk intravenous medications in a safe setting for 1 of 1 patient who received a high risk medication (Propofol) unsafely. (Patient #1)

On 1/20/2021 at 10:15 AM, review of the nurse progress notes in Patient #1's chart dated 12/24/2020 at 4:50 AM revealed "Propofol 100 milliliters(mls) hung." Review of Patient #1's Medication Administration record dated 12/24/2020 at 4:50 AM verified "Propofol infused at 20.6 milliliters per hour." Propofol 100 milliliters infusing at 20.6 milligrams(mgs)/liter(L) should infuse over 4.8 hours. Review of the patient's Medication Administration Record (MAR) verified Propofol 100 milliliters(mls) was hung at 4:50 AM and again at 7:37 AM to infuse at 20.6 milliliters/hour. On 1/20/2020 at 10:15 AM, review of the hospital's Pyxis log revealed that Propofol 100 milliliters(mls) was removed from the Pyxis for Patient #1 at 4:49 AM on 12/24/2020 and again at 7:35 AM on 12/24/20. Documentation in the patient's medication administration record verified by the hospital's Pyxis system revealed a 100 milliliter bottle of Propofol was documented as administered at 4:50 AM on 12/24/2020 and was infusing via a medication pump at 20.6 milliliters per hour, and a second 100 milliliter bottle of Propofol was documented as administered at 7:37 AM . The second bottle of Propofol was not on a medication pump, but was connected directly into a port located on the intravenous tubing below the medication infusion pump. On 1/20/2021 from 9:16 AM to 9:34 AM, during an interview with Registered Nurse(RN) #1 who verified that he/she was assigned as the Charge Nurse on the 7:00 AM - 7:00 PM shift on 12/24/2020, RN #1 stated "both bottles of Propofol were empty when the patient coded". When the Clinical Nursing ICU Director was asked if it is safe practice for nurses to hang a bottle of Propofol by attaching the bottle directly to the intravenous tubing without a pump while the previously hung bottle of Propofol was still infusing, the ICU Director said "No, it is not common practice. I don't know of anybody who does that. It is not a safe practice."

On 1/20/2021 at 10:15 AM, review of the nurse notes in Patient #1's chart revealed the patient's vital signs were documented as:
12/24/2020 at 07:30 AM: Pulse- 90, Respiratory Rate(RR) - 26 (High), and Oxygen (O2) Saturation(Sat) - 80
12/24/2020 at 07:32 AM: Pulse - 90, RR - 24(H= High)), O2 Sats- 81, Blood Pressure(BP) - 165/71(H)
12/24/2020 at 07:40 AM: Pulse- 88, RR - 18, O2 Sats - 81, BP - 161/68(H)
12/24/2020 at 07:47 AM: Pulse- 82, RR - 14, O2 Sats- 84, BP- 161/68 (H)
12/24/2020 at 07:50 AM: Pulse - 85, RR - 18, O2 Sats- 83
12/24/2020 at 08:00 AM: Pulse - 89, RR- 25(H). O2 Sats- 87
12/24/2020 at 08:01 AM: Pulse - 88, RR - 26(H), O2 Sats 86, BP 169/67 (H)
12/24/2020 at 08:02 AM: Pulse - 89, RR - 26(H), O2 Sats- 76, BP 169/67 (H)
12/24/2020 at 08:10 AM: Pulse - 74, RR- 32(H), O2 Sats- 88
12/24/2020 at 08:17 AM: Pulse - 89, RR -27 (H), O2 Sats 82, BP- 174/67
12/24/2020 at 08:20 AM: Pulse - 78, RR - 25(H), O2 Sats - 81
12/24/2020 at 08:30 AM: Pulse - 77, RR - 0 (L= Low), O2 Sats - 72
12/24/2020 at 08:40 AM: Pulse - 62, RR - 0 (L), O2 Sats 79
12/24/2020 at 08:41 AM: Pulse - 64, RR -5(L), O2 Sats - 75, BP - 32/21/ (Low)
12/24/2020 at 08:42 AM: RR - 14 (L), O2 Sat 87, BP- 32/21 (L)
12/24/2020 at 08:43 AM: Pulse - 63, RR - 10 (L), O2 Sats - 80, BP - 58/32
12/24/2020 at 08:45 AM: Code Initiated

On 1/20/2020 at 10:15 AM, review of the nurse progress notes for 12/24/2020 for the 7:00 AM - 7:00 PM shift revealed there was no notification of the physician of the changes in the patient's vital signs until 8:40 AM. Review of the nurse progress note documented for 8:40 AM (created 12/24/2020 at 10:59 AM) showed "Respiratory Therapist is room, assessing pt.(patient). Oxygen saturation 70s on ventilator. Pt(Patient) noted to be hypotensive. Heart rate 64. Vital signs per monitor. Dr......paged. Dr....paged. Levophed ordered stat. Pt noted to be PEA(pulseless electrical activity - cardiac arrest in which the electrocardiogram shows a heart rhythm that should produce a pulse but does not), cyanotic, Pt now supine, compressions initiated. Code blue called. Epinephrine drip ordered stat. Physician to unit. Pt to receive vasopressin drip. Normal saline bolus initiated. See code blue sheet."

Review of the hospital form, titled, "Code Blue Flowsheet" revealed the the code event occurred on 12/24/2020 at 08:45 AM, was witnessed, and cardiac compressions were instituted because Patient #1 was pulseless. Monitoring at onset of the code was by ECG(Electrocardiagram), Pulse Oximeter, and ETCO2. The code sheet showed the patient was already intubated prior to the onset of the code. Documentation on the code form showed:
8:45 AM: BP 32/21, Rhythm PEA, ETCO2 14, and 1 ampoule Epinephrine administered;
8:48 AM: BP 192/133, 1 ampoule Epinephrine and 1 ampoule Sodium Bicarbonate administered;
8:51 AM: BP 218/84, Rhythm ST(Sinus Tachycardia) ETCO2 30, ROSC(Return of Circulation)/Epi(Epinephrine) gtt(drop);
8:58 AM: Rhythm PEA, 1 ampoule Epinephrine, 1 ampoule Calcium Chloride;
9:00 AM: BP 227/87, Rhythm SR (Sinus Rhythm), 1 amp Sodium Bicarbonate, ROSC/Levophed;
9:06 AM: Rhythm PEA, 1 ampoule Ephinephrine, 1000 mgs Calcium Chloride;
9:08 AM: Rhythm PEA, 1 ampoule Sodium Bicarbonate, ROSC SR/ST(Sinus Tachcardia) 109;
9:12 AM: Rhythm PEA, 1 ampoule Epinephrine, increase Epi 20 mcg(micrograms)/min(minute);
9:14 AM: Rhythm ST, ROSC; 09:20 AM bp 116/94, 1 ampoule Sodium Bicarbonate;
9:22 AM: Rhythm SR, ROSC;
9:27 AM: BP 82/45, Rhythm SR, 1 liter Normal Saline bolus, Vasopressin gtt;
9:28 AM: Rhythm PEA, 1 ampoule Epinephrine;
9:32 AM: Rhythm PEA, 1 ampoule Epinephrine,
9:33 AM: Rhythm ST, ROSC;
9:48 AM: Rhythm PEA, 1 ampoule Epinephrine;
9:51 AM: Rhythm PEA, 1 ampoule Epinephrine;
9:52 AM: Rhythm ST, ROSC;
9:57 AM: Rhythm PEA, 1 ampoule Epinephrine, 1 ampoule Sodium Bicarbonate, ROSC;
10:00 AM: BP 81/30, Rhythm PEA, 1 ampoule Epinephrine;
10:02 AM: BP 113/62, SR, ROSC/DNR(Do Not Resuscitate);
10:12 AM: Expired.

On 1/20/2020 at 10:15 AM, review of the Physician Discharge Summary in Patient #1's chart revealed "......I was called in am on Dec 24 after she had cardiopulm arrest. Code blue was called and CPR was performed for approximately 70 minutes. .....During CPR the Diprivan bottle was noted to be empty by nursing. Verge report(adverse event) placed to evaluate further. ...I also spoke with pharmacy and they spoke with anesthesia about treatment for Propofol excess and recommended supportive care......".

RN #1- Charge Nurse (7:00 AM - 7:00 PM/12/24/2020)
On 1/20/2021 from 9:16 AM to 9:34 AM, during an interview in the hospital board room with Registered Nurse (RN) #1, RN #1 verified that he/she was the charge nurse on the 7:00 AM to 7:00 PM shift on 12/24/2020. RN #1 reported he/she was in Room 4 taking care of that patient when he/she "heard the desk monitor alarms for low Blood Pressure (BP) for the patient's (Patient #1) room". RN #1 reported the "first alarm for the patient's(Patient #1) blood pressure alarmed when the RT was doing rounds and on the floor." RN #1 reported he/she went to the patient's (Patient #1) room and saw the Respiratory Therapist (RT#1) was already there. RN #1 said "I asked RT (RT #1) to "recycle the patient's bp (blood Pressure) to make sure the reading was not an error". RN #1 said "I asked the RT (RT #1) to check the pulse. The RT (RT #1) said he/she couldn't feel the pulse." RN #1 said staff "started ACLS(Advanced Cardiac Life Support) protocol until the physician got there." RN #1 said "Staff flipped the patient onto the patient's back. . RN #1 said "RN #2 said "Both bottles of Propofol were empty, and the safety clamp was open." RN #1 reported "I have hung tubing for the medication to be ready to go but it was not attached to the patient."

RN #2 (Assigned Nurse Day 7:00 AM - 7:00 PM/12/24/2020)
On 1/22/2021 from 2:38 PM to 2:44 PM, during an interview in the hospital board room with RN #2, RN #2 revealed he/she readied the bottle of Propofol and inserted the Propofol into the port of the patient's intravenous tubing at 7:30 AM because there wasn't much left in the bottle that was hanging. RN #2 said that he/she is unable to remember the rate of the infusion. When asked how long it took him/her to assess the patient (Patient #1), RN #2 reported "It was awhile before the patient's BP was low." RN #2 said "I sat down by the monitor to chart and saw the RT(RT #1) leaving the patient's room, and I asked the RT about the patient's Oxygen reading of 70%". When questioned about when he/she noticed the Propofol containers were empty, RN #2 said "When I got the crash cart and walked by the pump, I saw the old bottle was empty and the new bottle was empty with fluid in the tubing".

Hospital policy, titled, IV Medications Infusion Chart, dated 09/20/2019, reads, "IV medication infusion chart.
Purpose: to provide guidelines for the administration of medication infusions in non-life-threatening circumstances.
Policy:
1. Only nurses, physicians, and/or licensed independent practitioners may administer IV infusion medication.
2. In an emergency situation, any category B medication may be administered on all floors, if on telemetry and if a transfer to a higher level of care is anticipated by the physician
3. Physicians are prohibited from deviating from the guidelines and set forth in the adult IV infusion medication administration chart and administering medication themselves via IV infusion
4. Any LPN or RN may administer an IV infusion who has documented competency and the infusion is administered on the appropriate unit according to the infusion chart.
5. If an ordered infusion is not listed on the chart, contact pharmacy for any questions and to request update or chart at next pharmacy and Therapeutics committee meeting

Administration procedure:
1. Obtain medication from pharmacy.
2. Check medication and dose with physician order
3. Prepare medication if needed
4. Prior to administration of medication to any patient the patient identification will be verified using to patient identifiers.
5. In areas where the EMAR is used to document medication, the correct medication will be verified by scanning the patient's ID bracelet and the medication.
6. If the medication does not scan, stop and notify the pharmacy
7. Provide education to patient regarding medication purpose and possible side effects.
8. Wash hands and don gloves. Ensure proper monitoring equipment is in place.
9. Using chlorhexidine, scrub the hub on the port for at least 15 seconds. Allow to draw, approximately 30 seconds.
10. Administer five ml normal saline flush to clear line and ensure patency
11. Administer medication per IV infusion administration guidelines.
12. Flush with five ml normal saline upon completion of infusion
13. Document administration of medication on EMAR and any required monitoring during the administration in the patient care notes....".

Review of ACLS(Advanced Cardiac Life Support) revealed "PEA, formerly known as electromechanical dissociation, occurs in patients who have organized cardiac electrical activity without a palpable pulse. 11 The absence of mechanical contractions is produced by factors that deplete myocyte high-energy phosphate stores and inhibit myocardial fiber shortening, including hypoxia, ischemia, metabolic acidosis, and ionic perturbations (particularly potassium and calcium changes). Various causes of pulseless electrical activity include significant hypoxia, profound acidosis, severe hypovolemia, tension pneumothorax, electrolyte imbalance, drug overdose, sepsis, large myocardial infarction, massive pulmonary embolism, cardiac tamponade, hypoglycemia, hypothermia, and trauma."

Based on record reviews, interviews, and review of the hospital's policies and procedures, the hospital's nursing service failed to ensure patients in the hospital's Intensive Care Unit (ICU) received the necessary care and services for the assessment, monitoring, and safe administration of high risk medications via the intravenous route for 1 of 1 patient receiving high risk intravenous medications. (Patient #1)

The findings are:

Cross Reference to A 0392: The hospital's nursing services failed to ensure patients in the Intensive Care Unit (ICU) received assessment, monitoring, and high risk intravenous medications in a safe setting for 1 of 1 patient who received a high risk medication (Propofol) unsafely. (Patient #1)

Cross Reference to A 0405: The hospital's nursing services failed to ensure patients in the Intensive Care Unit (ICU) received the nursing care and services for safe administration of high risk intravenous medications for 1 of 1 patient. (Patient #1)

Based on record reviews, interviews, and review of the hospital's policies and procedures, the hospital's nursing services failed to ensure patients in the Intensive Care Unit (ICU) received assessment, monitoring, and high risk intravenous medications in a safe setting for 1 of 1 patient who received a high risk medication (Propofol) unsafely. (Patient #1)

The findings are:

Observations
On 1/20/21 from 8:29 AM and 8:56 AM, observations of the Intensive Care Unit (ICU) and Overflow Intensive Care with the Patient Safety Officer, Vice President of Nursing, Clinical Nursing Intensive Care Unit Director and Head Nurse. Observations of the INC showed intravenous poles with intravenous fluids were stationed in the hallway outside patient rooms. The intravenous poles had long extension tubing that extended from the from the hall into the patient rooms under doorways to the patient bed. There were 10 beds in the ICU and 4 overflow ICU beds located on a hall outside the main ICU. Alarms for monitors and intravenous infusion pumps were audible. The main monitor for vital signs was observed with different colored lights and pop-up alarms.

Patient #1 Record Review
On 1/20/2021 at 10:15 AM, review of Patient #1's chart revealed the 74 year old patient was admitted to Bed 3 in the hospital's main Intensive Care Unit (ICU) on 12/20/2020 at 7:00 PM from a skilled nursing facility with diagnoses of COVID, Hyperkalemia, Respiratory Failure, and Encephalopathy. Review of the ambulance transport company's report revealed "....patient's oxygen saturation on room air is 56% (percent), placed on 12 liters oxygen via venti mask, and oxygen saturation 88%." Review of the physician order dated 12/22/2020 at 11:21 AM showed "Propofol IV (Intravenous) Emulsion 1,000 milligrams (mgs) per 100 milliliters(mls) starting rate 5 micrograms (mcg)/kilogram (kg) /minute (min). Titrate every 5 minutes until RASS score is at goal unless otherwise specified by physician." The RASS (Richmond Agitation - Sedation Scale ( 10- point scale, with 4 levels of anxiety, one level denoting a calm and alert state, and 5 levels of sedation. ) The RASS Scale Score of "-2 indicates light sedation described as "Briefly (less than 10 seconds) awakens with eye contact to voice)"; -3 indicates moderate sedation described as "Any movement (but no eye contact) to voice"; -4 indicates deep sedation described as "No response to voice, but any movement to physical stimulation"; and - 5 indicates un-arousable described as "No response to voice or physical stimulation"." Review of the nurse notes dated 12/24/2020 at 7:30 AM revealed the patient's RASS scores were documented as -3 (moderate sedation).

On 1/20/2021 at 10:15 AM, review of the nurse progress notes in Patient #1's chart dated 12/24/2020 at 4:50 AM revealed "Propofol 100 milliliters(mls) hung." Review of Patient #1's Medication Administration record dated 12/24/2020 at 4:50 AM verified "Propofol infused at 20.6 milliliters per hour." Propofol 100 milliliters infusing at 20.6 milligrams(mgs)/liter(L) should infuse over 4.8 hours. Review of the patient's Medication Administration Record (MAR) verified Propofol 100 milliliters(mls) was hung at 4:50 AM and again at 7:37 AM to infuse at 20.6 milliliters/hour. On 1/20/2020 at 10:15 AM, review of the hospital's Pyxis log revealed that Propofol 100 milliliters(mls) was removed from the Pyxis for Patient #1 at 4:49 AM on 12/24/2020 and again at 7:35 AM on 12/24/20. Documentation in the patient's medication administration record verified by the hospital's Pyxis system revealed a 100 milliliter bottle of Propofol was documented as administered at 4:50 AM on 12/24/2020 and was infusing via a medication pump at 20.6 milliliters per hour, and a second 100 milliliter bottle of Propofol was documented as administered at 7:37 AM . The second bottle of Propofol was not on a medication pump, but was connected directly into a port located on the intravenous tubing below the medication infusion pump. On 1/20/2021 from 9:16 AM to 9:34 AM, during an interview with Registered Nurse(RN) #1 who verified that he/she was assigned as the Charge Nurse on the 7:00 AM - 7:00 PM shift on 12/24/2020, RN #1 stated "both bottles of Propofol were empty when the patient coded". When the Clinical Nursing ICU Director was asked if it is safe practice for nurses to hang a bottle of Propofol by attaching the bottle directly to the intravenous tubing without a pump while the previously hung bottle of Propofol was still infusing, the ICU Director said "No, it is not common practice. I don't know of anybody who does that. It is not a safe practice."

On 1/20/2021 at 10:15 AM, review of the nurse notes in Patient #1's chart revealed the patient's vital signs were documented as:
12/24/2020 at 07:30 AM: Pulse- 90, Respiratory Rate(RR) - 26 (High), and Oxygen (O2) Saturation(Sat) - 80
12/24/2020 at 07:32 AM: Pulse - 90, RR - 24(H= High)), O2 Sats- 81, Blood Pressure(BP) - 165/71(H)
12/24/2020 at 07:40 AM: Pulse- 88, RR - 18, O2 Sats - 81, BP - 161/68(H)
12/24/2020 at 07:47 AM: Pulse- 82, RR - 14, O2 Sats- 84, BP- 161/68 (H)
12/24/2020 at 07:50 AM: Pulse - 85, RR - 18, O2 Sats- 83
12/24/2020 at 08:00 AM: Pulse - 89, RR- 25(H). O2 Sats- 87
12/24/2020 at 08:01 AM: Pulse - 88, RR - 26(H), O2 Sats 86, BP 169/67 (H)
12/24/2020 at 08:02 AM: Pulse - 89, RR - 26(H), O2 Sats- 76, BP 169/67 (H)
12/24/2020 at 08:10 AM: Pulse - 74, RR- 32(H), O2 Sats- 88
12/24/2020 at 08:17 AM: Pulse - 89, RR -27 (H), O2 Sats 82, BP- 174/67
12/24/2020 at 08:20 AM: Pulse - 78, RR - 25(H), O2 Sats - 81
12/24/2020 at 08:30 AM: Pulse - 77, RR - 0 (L= Low), O2 Sats - 72
12/24/2020 at 08:40 AM: Pulse - 62, RR - 0 (L), O2 Sats 79
12/24/2020 at 08:41 AM: Pulse - 64, RR -5(L), O2 Sats - 75, BP - 32/21/ (Low)
12/24/2020 at 08:42 AM: RR - 14 (L), O2 Sat 87, BP- 32/21 (L)
12/24/2020 at 08:43 AM: Pulse - 63, RR - 10 (L), O2 Sats - 80, BP - 58/32
12/24/2020 at 08:45 AM: Code Initiated

On 1/20/2020 at 10:15 AM, review of the nurse progress notes for 12/24/2020 for the 7:00 AM - 7:00 PM shift revealed there was no notification of the physician of the changes in the patient's vital signs until 8:40 AM. Review of the nurse progress note documented for 8:40 AM (created 12/24/2020 at 10:59 AM) showed "Respiratory Therapist is room, assessing pt.(patient). Oxygen saturation 70s on ventilator. Pt(Patient) noted to be hypotensive. Heart rate 64. Vital signs per monitor. Dr......paged. Dr....paged. Levophed ordered stat. Pt noted to be PEA(pulseless electrical activity - cardiac arrest in which the electrocardiogram shows a heart rhythm that should produce a pulse but does not), cyanotic, Pt now supine, compressions initiated. Code blue called. Epinephrine drip ordered stat. Physician to unit. Pt to receive vasopressin drip. Normal saline bolus initiated. See code blue sheet."

Review of the hospital form, titled, "Code Blue Flowsheet" revealed the the code event occurred on 12/24/2020 at 08:45 AM, was witnessed, and cardiac compressions were instituted because Patient #1 was pulseless. Monitoring at onset of the code was by ECG(Electrocardiagram), Pulse Oximeter, and ETCO2. The code sheet showed the patient was already intubated prior to the onset of the code. Documentation on the code form showed:
8:45 AM: BP 32/21, Rhythm PEA, ETCO2 14, and 1 ampoule Epinephrine administered;
8:48 AM: BP 192/133, 1 ampoule Epinephrine and 1 ampoule Sodium Bicarbonate administered;
8:51 AM: BP 218/84, Rhythm ST(Sinus Tachycardia) ETCO2 30, ROSC(Return of Circulation)/Epi(Epinephrine) gtt(drop);
8:58 AM: Rhythm PEA, 1 ampoule Epinephrine, 1 ampoule Calcium Chloride;
9:00 AM: BP 227/87, Rhythm SR (Sinus Rhythm), 1 amp Sodium Bicarbonate, ROSC/Levophed;
9:06 AM: Rhythm PEA, 1 ampoule Ephinephrine, 1000 mgs Calcium Chloride;
9:08 AM: Rhythm PEA, 1 ampoule Sodium Bicarbonate, ROSC SR/ST(Sinus Tachcardia) 109;
9:12 AM: Rhythm PEA, 1 ampoule Epinephrine, increase Epi 20 mcg(micrograms)/min(minute);
9:14 AM: Rhythm ST, ROSC; 09:20 AM bp 116/94, 1 ampoule Sodium Bicarbonate;
9:22 AM: Rhythm SR, ROSC;
9:27 AM: BP 82/45, Rhythm SR, 1 liter Normal Saline bolus, Vasopressin gtt;
9:28 AM: Rhythm PEA, 1 ampoule Epinephrine;
9:32 AM: Rhythm PEA, 1 ampoule Epinephrine,
9:33 AM: Rhythm ST, ROSC;
9:48 AM: Rhythm PEA, 1 ampoule Epinephrine;
9:51 AM: Rhythm PEA, 1 ampoule Epinephrine;
9:52 AM: Rhythm ST, ROSC;
9:57 AM: Rhythm PEA, 1 ampoule Epinephrine, 1 ampoule Sodium Bicarbonate, ROSC;
10:00 AM: BP 81/30, Rhythm PEA, 1 ampoule Epinephrine;
10:02 AM: BP 113/62, SR, ROSC/DNR(Do Not Resuscitate);
10:12 AM: Expired.

On 1/20/2020 at 10:15 AM, review of the Physician Discharge Summary in Patient #1's chart revealed "......I was called in am on Dec 24 after she had cardiopulm arrest. Code blue was called and CPR was performed for approximately 70 minutes. .....During CPR the Diprivan bottle was noted to be empty by nursing. Verge report(adverse event) placed to evaluate further. ...I also spoke with pharmacy and they spoke with anesthesia about treatment for Propofol excess and recommended supportive care......".

Interviews
Clinical Nursing Director ICU
On 1/20/2021 at 9:02 AM to 9:15 AM, during an interview in the hospital board room with Clinical Nursing ICU Director, the Director revealed he/she worked the night shift from 7:00 PM on 12/23/2020 to 7:00 AM on 12/24/2020. The Director verified Patient #1 was his/her assignment for that shift. The Director reported that during the night, the patient (Patient #1) had "increased Oxygen demand with Oxygen saturation in the low 80s and was turned prone approximately around 2:00 AM and 4:00 AM to help her breathe which increased Oxygen saturation to upper 80s". The Director reported that she handed off the patient to RN #2 at shift change. The Director reported that he/she returned to the ICU Unit for the night shift on 12/24/2020 and was informed by RN #2 that the patient (Patient #1) expired. The Director stated that RN #2 said,"I know I clamped the tubing."

RN #1- Charge Nurse (7:00 AM - 7:00 PM/12/24/2020)
On 1/20/2021 from 9:16 AM to 9:34 AM, during an interview in the hospital board room with Registered Nurse (RN) #1, RN #1 verified that he/she was the charge nurse on the 7:00 AM to 7:00 PM shift on 12/24/2020. RN #1 reported he/she was in Room 4 taking care of that patient when he/she "heard the desk monitor alarms for low Blood Pressure (BP) for the patient's (Patient #1) room". RN #1 reported the "first alarm for the patient's(Patient #1) blood pressure alarmed when the RT was doing rounds and on the floor." RN #1 reported he/she went to the patient's (Patient #1) room and saw the Respiratory Therapist (RT#1) was already there. RN #1 said "I asked RT (RT #1) to "recycle the patient's bp (blood Pressure) to make sure the reading was not an error". RN #1 said "I asked the RT (RT #1) to check the pulse. The RT (RT #1) said he/she couldn't feel the pulse." RN #1 said staff "started ACLS(Advanced Cardiac Life Support) protocol until the physician got there." RN #1 said "Staff flipped the patient onto the patient's back. . RN #1 said "RN #2 said "Both bottles of Propofol were empty, and the safety clamp was open." RN #1 reported "I have hung tubing for the medication to be ready to go but it was not attached to the patient."

Respiratory Therapist #1
On 1/20/2021 from 3:46 PM to 4:02 PM, during a telephone interview in the hospital board room with Respiratory Therapist (RT #1), RT #1 verified he/she worked the 7:00 AM shift on 12/24/2020. RT #1 reported " I started in ICU Room 1. After donning PPE(Personal Protective Equipment), I entered ICU Room 3 and no alarms were going off. Nothing of concern". RT #1 said, "Ventilator setting and checks were routine were done". RT #1 said "I left Room 3, doffed the PPE, and donned clean PPE to enter room 4, but before I could enter Room 4, RN #1 asked me to check the alarms going off in Room 3. I went back into the room. No one asked me to go back in and no alarms were going off and there was nothing of concern." RT #3 reported after entering Room 3, the patient's "pressures were dropping. We got the patient rolled over and eventually started CPR (Cardiopulmonary Resuscitation). "

RN #2 (Assigned Nurse Day 7:00 AM - 7:00 PM/12/24/2020)
On 1/21/2021 from 8:56 AM to 9:18 AM, a telephone interview in the hospital board room was conducted with RN #2 who veriifed he/she was assigned to the patient (Patient #1) on the 7:00 AM - 7 PM shift on 12/24/2020. RN #2 reported he/she received a verbal report from Clinical Nursing ICU Director who was assigned to the patient on the 7 PM - 7 AM shift from 12/23/2020 to 12/24/2020. RN #2 reported the Clinical Nursing ICU Director told her the patient's Propofol would be "finished soon". RN #2 verified that he/she hung the second bottle of Propofol from the Pyxis for Patient #1 at 7:35 AM because the first bottle hung on the night shift was almost empty. RN #2 reported "The pump kept beeping, and I would gown up to go inside the room to assess why the patient's pump going off, but the pump just kept beeping. Maybe the alarm was occluded. I had the new line ready to switch over with the new tubing to connect to the patient, but the tubing was attached to the outside intravenous line. The patient was prone, and I asked RN #3 to help me hold the patient over so I could assess the medication line in the patient's left groin". RN #2 said "The intravenous pump was outside Room 3(Patient #1's room) and infusing at 40 mgs per hour, I think, and the bottle was very low". RN #2 said, "I left the ICU Unit and went to the Overflow unit to help RN #3 turn her patients". When RN #2 was asked if anyone was informed that he/she was leaving the ICU, RN #2 replied, "I asked RN #4 and RN #1 to keep an eye on the patient". RN #2 reported "When I walked back into the ICU, the patient's pump was still beeping." RN #2 said that when he/she assessed the patient's IV pump alarm, the pump alarm showed "still occluded." RN #2 said, "I sat down at the nurse station to chart. I looked at the monitor and the patient's (Oxygen)sats were going down." RN #2 said "I noticed the RT(RT #1) coming out of the patient's room, and I asked the RT(RT #1) about the patient's (Oxygen)sats, and asked if the RT (RT #1) had called the pulmonologist." RN #2 stated "I stood up and noticed the bp on the monitor was low. I asked RN #5 to check the patient's BP cuff. RN #5 went into the patient's room. RT #1 was already in the room with RN #1 by the door of the patient's room. RT #1 helped flip the patient back over." RN #2 reported "I went to get the crash cart and when I went by the medication intravenous pump for the patient (Patient #1), I saw both bottles of Propofol were empty. I turned off the pump, but it didn't register." RN #2 said "About 15 minutes into the Code, I was thinking the Propofol went in. I said that out loud." RN #2 said "RN #4 told me that he/she hit the restart button while I was gone, but he/she would have checked if the new bag was ready to hang.

RN #4 (7:00 AM - 7:00 PM/12/24/2020)
On 1/21/2021 at 10:18 AM to 10:42 AM, during an interview in the hospital board room with RN #4 , RN #4 verified he/she worked 7 AM to 7 PM on 12/24/2020. RN #4 reported "A lot was going on. Anxiety was high. It was very stressful. I was stressed to get my meds(medications) out. We help each other out. I remember her (RN #2) saying to keep an eye out." When asked about Patient 1's IV infusion pump, RN #4 reported "I heard it alarming. Might have been for occlusion. I hit restart and it goes automatic silence. Each IV infusion pump has 3 alarms: low battery, occlusion which is in red lettering, and air in line which is in yellow lettering".
RN #4 reported "I saw low BP(blood pressure) on the monitor. I asked (RN #2) about the patient's BP being low."

Clinical Nursing ICU Director
On 1/22/2021 at 9:06 AM, an interview in the hospital board room with Clinical Nursing ICU Director, the Director verified Propofol was documented on Patient #1's Medication Administration Record on 12/24/2020 at 4:50 AM and and again at 7:37 AM to infuse at 20.6 milliliters/hour.

Pharmacist #1
On 1/22/2021 from 1:05 PM to 1:14 PM, during an interview in the hospital board room with Pharmacist #1, he/she verified the dosage of Propofol 30 mcg(micrograms) per hour is infused at 20.6 ml per hour and at this dosage, a 100 ml bottle of Propofol would infuse "around 5 hours but not quite." Pharmacist #1 said, "Any changes in the dosage and rate of infusion shows up on the patient's MAR if nurses change the rates." Pharmacist #1 reported the MAR records the time when the medication is scanned and when the patient's bracelet is scanned.

Clinical Nursing ICU Director
On 1/22/2021 from 1:24 PM to 1:31 PM, during an interview in the hospital board room with Clinical Nursing ICU Director, the Director verified "If Propofol could have been titrated in between, the titration should have been documented". The Clinical Nursing ICU Director stated "If a bottle of 100 mls Propofol is started at 4:50 AM, the medication would be finished infusing around 9:50 AM, and at 8:50 AM that morning, there should have been an additional 20 mls in the bag". The Director reported that when he/she left at approximately 7:00 AM, the Propofol for Patient #1 was infusing at 20.6 ml per hour.

RN #2 (Assigned Nurse Day 7:00 AM - 7:00 PM/12/24/2020)
On 1/22/2021 from 2:38 PM to 2:44 PM, during an interview in the hospital board room with RN #2, RN #2 revealed he/she readied the bottle of Propofol and inserted the Propofol into the port of the patient's intravenous tubing at 7:30 AM because there wasn't much left in the bottle that was hanging. RN #2 said that he/she is unable to remember the rate of the infusion. When asked how long it took him/her to assess the patient (Patient #1), RN #2 reported "It was awhile before the patient's BP was low." RN #2 said "I sat down by the monitor to chart and saw the RT(RT #1) leaving the patient's room, and I asked the RT about the patient's Oxygen reading of 70%". When questioned about when he/she noticed the Propofol containers were empty, RN #2 said "When I got the crash cart and walked by the pump, I saw the old bottle was empty and the new bottle was empty with fluid in the tubing".

Policies and Procedures
Review of ACLS(Advanced Cardiac Life Support), revealed, "PEA, formerly known as electromechanical dissociation, occurs in patients who have organized cardiac electrical activity without a palpable pulse. 11 The absence of mechanical contractions is produced by factors that deplete myocyte high-energy phosphate stores and inhibit myocardial fiber shortening, including hypoxia, ischemia, metabolic acidosis, and ionic perturbations (particularly potassium and calcium changes). Various causes of pulseless electrical activity include significant hypoxia, profound acidosis, severe hypovolemia, tension pneumothorax, electrolyte imbalance, drug overdose, sepsis, large myocardial infarction, massive pulmonary embolism, cardiac tamponade, hypoglycemia, hypothermia, and trauma."

Hospital policy, titled, IV Medications Infusion Chart, dated 09/20/2019, reads, "IV medication infusion chart.
Purpose: to provide guidelines for the administration of medication infusions in non-life-threatening circumstances.
Policy:
1. Only nurses, physicians, and/or licensed independent practitioners may administer IV infusion medication.
2. In an emergency situation, any category B medication may be administered on all floors, if on telemetry and if a transfer to a higher level of care is anticipated by the physician
3. Physicians are prohibited from deviating from the guidelines and set forth in the adult IV infusion medication administration chart and administering medication themselves via IV infusion
4. Any LPN or RN may administer an IV infusion who has documented competency and the infusion is administered on the appropriate unit according to the infusion chart.
5. If an ordered infusion is not listed on the chart, contact pharmacy for any questions and to request update or chart at next pharmacy and Therapeutics committee meeting

Administration procedure:
1. Obtain medication from pharmacy.
2. Check medication and dose with physician order
3. Prepare medication if needed
4. Prior to administration of medication to any patient the patient identification will be verified using to patient identifiers.
5. In areas where the EMAR is used to document medication, the correct medication will be verified by scanning the patient's ID bracelet and the medication.
6. If the medication does not scan, stop and notify the pharmacy
7. Provide education to patient regarding medication purpose and possible side effects.
8. Wash hands and don gloves. Ensure proper monitoring equipment is in place.
9. Using chlorhexidine, scrub the hub on the port for at least 15 seconds. Allow to draw, approximately 30 seconds.
10. Administer five ml normal saline flush to clear line and ensure patency
11. Administer medication per IV infusion administration guidelines.
12. Flush with five ml normal saline upon completion of infusion
13. Document administration of medication on EMAR and any required monitoring during the administration in the patient care notes....".

Hospital policy, titled, "Adult Infusion Medication Administration Chart, effective 09/2019, reads, Propofol (Diprivan), Category B, vital signs, neurological function, cardiorespiratory depression(BP, pulse oximetry, ECG(Electrocardiogram), HR (Heart Rate), Propofol infusion syndrome (metabolic acidosis, hyperkalemia, rhabdomyolis, elevated CPK, enlarged liver, progression of cardiac/renal failure)....".

Based on record reviews, interviews, and review of the hospital's policies and procedures, the hospital's nursing services failed to ensure patients in the Intensive Care Unit (ICU) received the nursing care and services for safe administration of high risk intravenous medications for 1 of 1 patient. (Patient #1)

The findings are:

Cross Reference to A 0392: The hospital's nursing services failed to ensure patients in the Intensive Care Unit (ICU) received assessment, monitoring, and high risk intravenous medications in a safe setting for 1 of 1 patient who received a high risk medication (Propofol) unsafely. (Patient #1)

On 1/20/2021 at 9:02 AM to 9:15 AM, the ICU Clinical Director reported that she handed off the patient to RN #2 at shift change on 12/24/2020 at 07:00 AM. The Director reported that he/she returned to the ICU Unit for the night shift on 12/24/2020 at 7:00 PM and was informed by RN #2 that the patient (Patient #1) expired. The Director stated that RN #2 said,"I know I clamped the tubing."

On 1/20/2021 from 9:16 AM to 9:34 AM, during an interview in the hospital board room with Registered Nurse (RN) #1, RN #1 verified that he/she was the charge nurse on the 7:00 AM to 7:00 PM shift on 12/24/2020. RN #1 reported he/she was in Room 4 taking care of that patient when he/she "heard the desk monitor alarms for low Blood Pressure (BP) for the patient's (Patient #1) room". RN #1 reported the "first alarm for the patient's(Patient #1) blood pressure alarmed when the RT was doing rounds and on the floor." RN #1 reported he/she went to the patient's (Patient #1) room and saw the Respiratory Therapist (RT#1) was already there. RN #1 said "I asked RT (RT #1) to "recycle the patient's bp (blood Pressure) to make sure the reading was not an error". RN #1 said "I asked the RT (RT #1) to check the pulse. The RT (RT #1) said he/she couldn't feel the pulse." RN #1 said staff "started ACLS(Advanced Cardiac Life Support) protocol until the physician got there." RN #1 said "Staff flipped the patient onto the patient's back. . RN #1 said "RN #2 said "Both bottles of Propofol were empty, and the safety clamp was open." RN #1 reported "I have hung tubing for the medication to be ready to go but it was not attached to the patient."

On 1/21/2021 from 8:56 AM to 9:18 AM, a telephone interview in the hospital board room was conducted with RN #2 who veriifed he/she was assigned to the patient (Patient #1) on the 7:00 AM - 7 PM shift on 12/24/2020. RN #2 reported he/she received a verbal report from Clinical Nursing ICU Director who was assigned to the patient on the 7 PM - 7 AM shift from 12/23/2020 to 12/24/2020. RN #2 reported the Clinical Nursing ICU Director told her the patient's Propofol would be "finished soon". RN #2 verified that he/she hung the second bottle of Propofol from the Pyxis for Patient #1 at 7:35 AM because the first bottle hung on the night shift was almost empty. RN #2 reported "The pump kept beeping, and I would gown up to go inside the room to assess why the patient's pump going off, but the pump just kept beeping. Maybe the alarm was occluded. I had the new line ready to switch over with the new tubing to connect to the patient, but the tubing was attached to the outside intravenous line. RN #2 reported "I went to get the crash cart and when I went by the medication intravenous pump for the patient (Patient #1), I saw both bottles of Propofol were empty. I turned off the pump, but it didn't register." RN #2 said "About 15 minutes into the Code, I was thinking the Propofol went in. I said that out loud." RN #2 said "RN #4 told me that he/she hit the restart button while I was gone, but he/she would have checked if the new bag was ready to hang.

Clinical Nursing ICU Director
On 1/22/2021 at 9:06 AM, an interview in the hospital board room with Clinical Nursing ICU Director, the Director verified Propofol was documented on Patient #1's Medication Administration Record on 12/24/2020 at 4:50 AM and and again at 7:37 AM to infuse at 20.6 milliliters/hour.

Pharmacist #1
On 1/22/2021 from 1:05 PM to 1:14 PM, during an interview in the hospital board room with Pharmacist #1, he/she verified the dosage of Propofol 30 mcg(micrograms) per hour is infused at 20.6 ml per hour and at this dosage, a 100 ml bottle of Propofol would infuse "around 5 hours but not quite." Pharmacist #1 said, "Any changes in the dosage and rate of infusion shows up on the patient's MAR if nurses change the rates." Pharmacist #1 reported the MAR records the time when the medication is scanned and when the patient's bracelet is scanned.

RN #2
On 1/22/2021 from 2:38 PM to 2:44 PM, when asked when he/she noticed the Propofol containers were empty, RN #2 said "When I got the crash cart and walked by the pump, I saw the old bottle was empty and the new bottle was empty with fluid in the tubing".

Policies and Procedures
Review of ACLS(Advanced Cardiac Life Support), revealed, "PEA, formerly known as electromechanical dissociation, occurs in patients who have organized cardiac electrical activity without a palpable pulse. 11 The absence of mechanical contractions is produced by factors that deplete myocyte high-energy phosphate stores and inhibit myocardial fiber shortening, including hypoxia, ischemia, metabolic acidosis, and ionic perturbations (particularly potassium and calcium changes). Various causes of pulseless electrical activity include significant hypoxia, profound acidosis, severe hypovolemia, tension pneumothorax, electrolyte imbalance, drug overdose, sepsis, large myocardial infarction, massive pulmonary embolism, cardiac tamponade, hypoglycemia, hypothermia, and trauma."

Hospital policy, titled, IV Medications Infusion Chart, dated 09/20/2019, reads, "IV medication infusion chart.
Purpose: to provide guidelines for the administration of medication infusions in non-life-threatening circumstances.
Policy:
1. Only nurses, physicians, and/or licensed independent practitioners may administer IV infusion medication.
2. In an emergency situation, any category B medication may be administered on all floors, if on telemetry and if a transfer to a higher level of care is anticipated by the physician
3. Physicians are prohibited from deviating from the guidelines and set forth in the adult IV infusion medication administration chart and administering medication themselves via IV infusion
4. Any LPN or RN may administer an IV infusion who has documented competency and the infusion is administered on the appropriate unit according to the infusion chart.
5. If an ordered infusion is not listed on the chart, contact pharmacy for any questions and to request update or chart at next pharmacy and Therapeutics committee meeting

Administration procedure:
1. Obtain medication from pharmacy.
2. Check medication and dose with physician order
3. Prepare medication if needed
4. Prior to administration of medication to any patient the patient identification will be verified using to patient identifiers.
5. In areas where the EMAR is used to document medication, the correct medication will be verified by scanning the patient's ID bracelet and the medication.
6. If the medication does not scan, stop and notify the pharmacy
7. Provide education to patient regarding medication purpose and possible side effects.
8. Wash hands and don gloves. Ensure proper monitoring equipment is in place.
9. Using chlorhexidine, scrub the hub on the port for at least 15 seconds. Allow to draw, approximately 30 seconds.
10. Administer five ml normal saline flush to clear line and ensure patency
11. Administer medication per IV infusion administration guidelines.
12. Flush with five ml normal saline upon completion of infusion
13. Document administration of medication on EMAR and any required monitoring during the administration in the patient care notes....".

Hospital policy, titled, "Adult Infusion Medication Administration Chart, effective 09/2019, reads, Propofol (Diprivan), Category B, vital signs, neurological function, cardiorespiratory depression(BP, pulse oximetry, ECG(Electrocardiogram), HR (Heart Rate), Propofol infusion syndrome (metabolic acidosis, hyperkalemia, rhabdomyolis, elevated CPK, enlarged liver, progression of cardiac/renal failure)....".