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Tag No.: A0263
Based on review of meeting minutes, quality improvement data and staff interviews it was determined that the facility failed to maintain an effective, ongoing, hospital-wide, data driven quality assessment and performance improvement program which identified trends in bar code medication administration (BCMA) compliance to decrease medication errors and report on findings through the QAPI process.
Cross refer to A -0283 as it relates to the facility's failure to identify opportunities for improvement and change that led to improvements in compliance with BCMA when it was determined that 9 of 19 units failed to meet the target of 95% compliance.
Tag No.: A0273
Based on review of policy and procedures, meeting minutes, quality improvement data and staff interviews it was determined that the facility failed utilize data to identify opportunities for improvement, implement actions for improvement, and monitor for effectiveness when two (P#1 and P#5) of five (P#1, P#2, P#3, P#4, P#5) sampled patients were administered the incorrect medication.
Findings included:
A review of the facility's 'Patient Safety Plan 2023' revealed that Quality and system analyses are used to identify, analyze, and design measures to decrease the likelihood of medical errors and promote a learning environment of lessons learned through SAFERS, Safety Alerts, Good Catches, etc. The knowledge acquired through these reviews supports a High Reliability Organization (HRO). Continued review of the plan revealed that the goal of analyzing safety events was to determine the core contributing system factor to the adverse event, rather than focusing on human error. Tools used to support the analysis included root cause analysis, failure mode and effects analysis, 5 Whys, Cause and Effect diagram, etc.
A review of Quality Management System Oversight Committee (QMSOC) Meeting minutes for September 2022 through February 2023 revealed that BCMA data was included in the meeting minutes for December 2022. A review of the Pharmacy/Medication Safety Committee report included in the Quality Management Oversight Committee for November and December 2022 revealed that the year-to-date BCMA compliance facility-wide was 96%. The target compliance was 95%. Continued review revealed that BCMA compliance would continue to be monitored.
A review of an email dated 2/24/23 that included January 2023 BCMA compliance revealed that 8 of 19 units were below the target compliance of 95%.
A review of an email dated 3/6/23 that included February 2023 BCMA compliance revealed that 9 of 19 units were below the target compliance of 95%.
An interview was conducted with AMP DD on 3/23/23 at 9:49 a.m. in the conference room. AMP DD stated the bar codes were monitored monthly, and each unit was meeting up to 95 percent expectations.
Tag No.: A0385
Based on review of medical records, policy and procedures and staff interviews it was determined that the facility failed to implement an effective system for the safe preparation and administration of medications by the nursing staff. Specifically, two (P#1 and P#5) of five (P#1, P#2, P#3, P#4, P#5) sampled patients were administered the incorrect medication by a member of the nursing staff.
The findings include:
A review of P#1's medical record revealed on 12/20/22, P#1's physician orders were for an infusion of dobutamine when P#1 was found in cardiac arrest. Staff observed after a patient transfer that P#1 had received Cardizem instead of dobutamine as ordered. P#1 expired on 12/23/22.
A review of P#5's medical record revealed that he had been diagnosed with acute renal failure and found to have high potassium of 8.5 (normal 4.5-5.5) in his blood. It was determined that on 2/8/23, P#5 received the incorrect IV fluids which contained potassium. P#5 developed seizures and was transferred to the intensive care unit.
Cross refer to A-0405 as it relates to the facility's failure to ensure that medications were administered as ordered per a physician order.
Tag No.: A0405
Based on a review of policy and procedures, medical records and staff interviews, it was determined that the facility failed to ensure that medications were prepared and administered in accordance with physician orders and acceptable standards of practice when two patients (P#1 and P#5), of five (P#1, P#2, P#3, P#4, P#5) sampled patients were administered the incorrect medication.
Findings:
A review of the facility policy titled "Nursing Medication Order Transcription, Verification, and Administration," revised 11/29/2022, revealed the process by which medication orders were transcribed, verified, and administered. Further review of the policy revealed that medications would be administered by the nurse according to the "Six (6) Rights of Medication Administration."
i. Right patient
ii. Right drug
iii. Right dose
iv. Right route
v. Right time
vi. Right documentation
A detailed review of the policy stated the nurse would assess patient identification bands and allergy bands prior to medication administration and use two (2) identifiers prior to medication administration.
A review of the medical record (MR) revealed that Patient (P) #1 was a 64- year- old male who was diagnosed with paroxysmal atrial fibrillation (heart beats irregularly) and a dilated cardiomyopathy systolic heart failure (the heart is unable to pump blood efficiently ). P#1 also had a past medical history of coronary artery disease (obstruction in the artery that supplies the heart, limiting blood flow to the heart) and congestive heart failure (the heart is unable to pump blood efficiently). P#1 was admitted to the facility's inpatient unit on 12/11/22 at 9:28 a.m.
A review of P#1's history and physical examination dated 12/11/22 at 2:27 p.m. revealed a treatment plan that included dobutamine (medication to manage low blood pressure, for treating heart failure) for cardiogenic shock, rivaroxaban (blood thinner medication to prevent clot) and amiodarone (anti arrhythmia medication) for atrial fibrillation.
On 12/20/22 at 1:23 a.m., Registered Nurse (RN) BB documented that P#1 was found unresponsive at the bedside. No pulse was palpable, a code blue (emergency code for cardiac or respiratory arrest) was called, and chest compressions were started.
On 12/20/22 at 2:10 a.m., RN CC documented that P#1 arrived in the surgical intensive care unit (ICU) intubated (tube placed to assist breathing) with Medical Doctor (MD) GG at the bedside. RN CC documented that physician orders included dobutamine. RN CC observed that the intravenous (IV) pump was programmed for dobutamine with the rate as ordered; however, the medication bag being administered was labeled Cardizem (medication used to slow heart rate). RN CC documented that the medication was stopped, and MD GG was notified. Dobutamine was requested from the pharmacy.
A review of the progress notes dated 12/21/22 at 11:05 a.m., Nurse Practitioner (NP) HH noted that P#1 was found bradycardic (slow heart rate), essentially losing a pulse before the code blue event. Further review of the progress note revealed that P#1 was supposed to be on a dobutamine drip (IV medication); however, he was not on a dobutamine drip. Additionally, P#1 was noted to have a Cardizem drip running, which was labeled as a ketamine drip. The nursing staff was unsure how long P#1 was on the medication.
A review of the clinical notes dated 12/22/22 at 5:45 p.m. revealed that P#1 went apneic (stopped breathing), and his family was called. A review of P#1 death record revealed that P#1 was pronounced dead at the facility on 12/22/22 at 5:37 p.m. P#1 cause of death was cardiac arrest.
A review of P#5 MR Transfer Summary dated 2/9/23 revealed that P#5 was admitted to the facility on 2/8/23 with abdominal pain and difficulty urinating. P#5 was diagnosed with acute renal (kidney) failure and found to have high potassium of 8.5 (normal 4.5-5.5) in his blood. P#5 was placed on continuous bicarbonate infusion (medication for kidney function).
Further review of P#5's medial record revealed P#5 received potassium-containing fluids instead of the bicarbonate infusion ordered by the physcian. P#5 soon after developed seizures and was transferred to the ICU.
An interview was conducted with RN EE on 3/23/23 at 9:11 a.m. in the conference room. RN EE stated that she did not remember caring for P#1. RN EE further explained that administering medication included removing medication from the Pyxis (automated medication dispensing system), using the bar code scanner to scan the medication, and verifying the correct name, dose, frequency, and type of medication in the Medication Administration Record (MAR). RN EE said if the bar code scanner did not work correctly, staff were still required to follow the six rights of medication administration. RN EE stated if the process was followed accordingly, it would be unusual to administer the wrong medication to a patient.
An interview was conducted with Patient Safety Coordinator (PSC) AA on 3/23/23 at 9:23 a.m. in the conference room. PSC AA explained that the Patient Safety Unit team began investigating after being notified of the medication error. PSC AA and Manager of Patient Safety (AMP) DD conducted interviews separately with RN BB and RN CC. PSC AA said RN BB told AMP DD that she had been caring for P#1 for a couple of days, and P#1 had been on continuous dobutamine. However, there were issues with scanning the dobutamine. PSC AA said RN BB explained that she was hasty to see another patient, so she took the bag at the nursing station, which she thought was P#1's dobutamine and hung it in P#1's room. PSC AA stated that the facility did a root cause analysis (RCA), deemed the incident a serious safety event, and had several meetings with hospital leadership. PSC AA said the facility identified gaps in care, including vital signs being taken less often than required by policy for a patient on dobutamine. PSC AA explained that another gap identified was that the nurse did not scan medications as required. PSC AA recalled that scan reports across the units were reviewed to see if other staff were also not scanning medications but realized there were no scanning issues. PSC AA said they gave instructions on how often vitals should be taken for the patient and re-educated staff on vasoactive (blood vessels to get narrower or wider) work instructions. PSC AA further explained that RN BB received written disciplinary action and was required to attend medical-surgical education.
An interview was conducted with AMP DD on 3/23/23 at 9:49 a.m. in the conference room. AMP DD recalled that she was notified of a medication error with P#1 and went to the STICU to gather information about the incident. The STICU nurse (RN CC) reported finding the wrong bag of medication hung for P#1. RN CC said he took it down and notified MD GG. RN CC then started the correct medication. AMP DD interviewed RN BB and was told that she (RN BB) had P#1 for a couple of days. P#1 was at the hospital for cardiac ablation (procedure to correct heart rhythm problems). P#1 was started on dobutamine for low blood pressure. RN BB said it was a busy day, and another patient was upset, so she quickly grabbed the bag at the nursing station and hung it to prevent P#1's medication from running out. AMP DD said RN BB had previous issues with scanning dobutamine due to labeling issues, so she didn't scan the medication, hung it, and went to meet another patient. AMP DD said the wrong medication was started around 10:47 p.m. on 12/20/23. AMP DD further explained that around 1:43 a.m. on 12/21/23, P#1 coded (not breathing and/or no heartrate). AMP DD said the pharmacy department was notified after the incident, and education was provided to the staff to ensure that medications were correctly labeled. AMP DD said they talked to the staff, looked at the process, conducted a root cause analysis, discussed with hospital leaders, and the nursing leaders provided education on medication administration and bar code monitoring which was relayed to the nursing staff during huddles. AMP DD stated the bar codes were monitored monthly, and each unit was meeting up to 95 percent expectations.
An interview was conducted with the RN FF on 3/23/23 at 11:04 a.m. in the conference room. RN FF, a STICU nurse, recalled responding to the medical surgical unit when P#1 coded. RN FF further explained that upon bringing P#1 to the STICU, RN CC found the wrong medication (Cardizem) instead of dobutamine on P#1. RN FF said MD GG was notified, and the medication was immediately stopped. RN FF said she had not experienced issues with scanning medication. RN FF further explained that if she had an issue with scanning a medication, she would override the scanning and administer the medication manually using the five (5) rights.
An interview was conducted with RN BB on 3/23/23 at 11:19 a.m. in the conference room. RN BB explained that P#1 had been on a continuous dobutamine drip, the wrong medication was hung, and she had to call a code. RN BB further explained that P#1 was assigned to her; it was the fourth night she had cared for him. RN BB said she knew P#1 would get a new bag of continuous dobutamine and that she had been unable to scan dobutamine the previous weekend. She had to manually program the pump and chart on the medication record (MAR). RN BB said she hung what she thought was dobutamine; however, the medication hung was Cardizem. RN BB said she hung the wrong medication in a hurry and went to check on another patient who needed help. RN BB said she intended to document the medication in the MAR manually but didn't. RN BB said she would usually scan the patient's wristband, the medication, and the pump. RN BB said she would verify that the dosage, drug, and frequency of medication was correct. RN BB said the issue was with the medication labeling, not the bar code. RN BB said she was aware that the pharmacy should be called if there was a scanning issue; however, this was an ongoing issue. RN BB said the only solution to a medication, not scanning, was to enter the medication manually. RN BB said it might be helpful to put different stickers with different color codes to indicate different medications rather than a single white label. RN BB said she was required to attend a transitioning class and was currently in those classes.
An interview was conducted with RN CC on 3/23/23 at 11:55 a.m. in the conference room. RN CC explained that P#1 was brought from the medical-surgical unit to the STICU after coding. RN CC recalled that after P#1 arrived at the unit, he noted that Cardizem was hanging instead of the dobutamine programmed into the IV pump. RN CC said he immediately stopped the Cardizem and notified MD GG. RN CC recalled that dobutamine was obtained from the pharmacy. RN CC said he had no issue scanning medications. RN CC said he would have another staff cross-check medications and document manually if he had issues with the barcode scanner.
An interview was conducted with the NP HH on 3/23/23 at 12:22 p.m. in the conference room. NP HH said she was not present when P#1 coded, but she was informed that P#1 had coded overnight and was brought to the STICU upon her arrival the next morning. NP HH had been informed that RN CC had found the wrong medication being administered. NP HH stated that diltiazem had not been ordered, and MD GG said it got hung accidentally. NP HH said P#1 was completely obtunded (a reduced level of alertness) and on a ventilator. NP HH said some brain reflexes were intact, but he had no cough gag and was not withdrawing to pain.