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10628 PARK RD

CHARLOTTE, NC 28210

PATIENT SAFETY

Tag No.: A0286

Based on policy review, medical record review, medication error incident report and staff interviews, facility staff failed to analyze a medication error at the earliest opportunity for actions needed for improvement; and failed to monitor and track measures taken to prevent medication errors for 1 of 1 medication error reports reviewed (Patient #18).

Findings included:

Review of the facility's "2023 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT PLAN" revealed, "... The Quality and Equity of Care Committee (QEC) shall have primary responsibility for the following functions: ... 2.. Medical Error Reduction: The QEC shall: a) assure there is a process for measurable improvement in the reduction of medical errors through implementation of best practices; b) assure that the system for the identification of medical errors within the institution is effective; c) oversee the analysis of near misses within the institution to assure that the root cause(s) is identified, and appropriate preventative actions and mechanisms (including feedback and learning throughout the hospital) are implemented. 3. Quality Indicators: The QEC shall oversee measurement, and shall analyze and track quality indicators, including adverse patient events, and other aspects of performance. ..."

Review of the facility's "CARE EVENT REPORTING" policy approved 02/10/2022 revealed, "...The purpose of this system is to identify patient safety issues, potentially compensable events and opportunities for improvement. (Hospital system name) recognizes the importance of early identification and expects its employees to complete a CARE Event for any occurrence which occurs in the facility or on its premises that is not consistent with routine patient care or operation of the facility that either did or could directly result in injury to a patient or visitor. ... PROCEDURE: A. The person discovering, directly involved, or closest to the event should complete an online CARE Event Report within 24 hours. ... RESPONSIBILITIES: a. Management Responsibilities ... 3. Designated management person will review the email notification for completeness and conduct the initial investigation as needed. 4. Corrective action and follow-up will be overseen by the manager. Manager will contact any other departments involved and coordinate corrective efforts as needed. ..."

Medical record review on 07/10/2024 for Patient #18 revealed an 77 year-old female admitted on 01/19/2023 with acute metabolic encephalopathy (brain dysfunction causing confusion) due to hypoglycemia (low blood sugar level). Review of a physician's History and Physical dated 01/19/2023 at 2335 recorded a history of urinary retention and erythromelagia (a rare vascular peripheral pain disorder usually in the lower extremities). Review revealed the patient had hypoglycemia of unclear etiology with a plan to monitor blood sugar levels. Review of physician's orders revealed an order dated 01/20/2023 at 1742 for "carvedilol (Coreg) 25 milligrams (mg) two times daily. Hold for SBP (systolic blood pressure) less than 95 or heart rate less than 55. If dose is held, check heart rate and blood pressure Q 1HR X2 (every hour times two). If SBP greater than 95 and heart rate greater than 55, administer med. If not, call MD (medical doctor) for action." Review of the patient's electronic medication administration record (MAR) revealed Patient #18 was administered carvedilol 25 mg on 01/20/2023 at 1749 and 01/21/2023 at 1029. Review of a nursing note dated 01/21/2023 at 1600 recorded, "Patient's husband (name) brought to my attention that the patient should not be on Coreg (carvedilol), because oddly, this is his medication. She has never been on it before, and somehow it ended up on her Home Med List on admission. This was brought to the Attending MD's attention, (name) and the Charge Nurse (name). The med had already been given today, and it was d/c'd by the MD. The patient's HR (heart rate) dipped down in to the low 40s today, and the husband was particularly upset about this. (Name of staff member) went to the bedside to do another med rec and the husband seemed to be pleased with this." Review revealed the medication was discontinued on 01/21/2023 at 1632. Record review revealed the patient was discharged home on 02/05/2025.

Review of a "Care Event Notification" regarding Patient #18 documented a medication error that occurred on 01/21/2023. The event description revealed, "Pt (patient) was given Coreg (carvedilol), husband states she doesn't take it and it keeps coming up on her PTA (prior to arrival) med list. MD aware of pt. receiving med and d/c (discontinued). I spoke with med rec tech and med removed off home list. ... Extent of Harm: No Harm - Event reached Patient, but no harm. ..."

Interview on 07/11/2024 at 0930 with the manager of pharmacy tech services revealed a med rec tech had two lists that were reviewed to complete the patient's home medication list. The med rec tech verified with Patient #18 that she was taking carvedilol The home medication list was created based on that verification and the physician ordered the medication. Interview revealed the med rec tech had no concerns with the patients ability to verify the home meds. Interview revealed the patient was administered the medication. The patient's husband found the patient lethargic and asked what meds the patient had been given and told the nurse that carvedilol was not a medicine that she took. The nurse notified the physician and the medication was discontinued. An incident report was created and identified as "no harm" to the patient. Interview confirmed no action was taken as a result of medication error report.

Review of a grievance submitted on 03/08/2023 at 1543 by Patient #18's family member revealed he became aware of his wife being administered the wrong medication, carvedilol on January 7, 2023. He alleged that the carvedilol that she was administered was actually a medication that he (the husband) took that was prescribed by his cardiologist. The grievance recorded that the carvedilol was not on the home medication list that was given to the emergency department when the patient arrived. Further review of the narrative revealed, "... 05/11/2023 Received the following email: THM To whom would you like to send this message: ... Message: On March 8th of this year, I spoke with a representative of (hospital name) on a recorded line about three (3) incidents at (name of hospital) where my wife, (Patient #18 name), was a patient several times since August of 2022. In late March a letter addressed to my wife said an investigation was begun into the issues I had mentioned. My wife died on March 14th while in Hospice End of Life care. I would like to know what the results of your investigation were, and what changes (hospital name) has made to prevent the error made in administration of an unapproved medication to my wife. ..." Review of the "Responder Comments" revealed, "... Upon chart review the above medication (carvedilol) was ordered on her EMR (electronic medical record). ... 3/22/2023 - After reviewing the chart, I see that the patient had carvedilol listed on her medications by the pharmacy tech. This was continued by the physician. Dr. (name) the next day discontinued this medication. Do not feel that this causes any sort of adverse side effects. Care overall was appropriate. - (MD name) 3/23/2023- The patient had an order at the pharmacy that was filled 1-6-23 for carvedilol 25mg (milligrams) bid (twice a day). I had the med rec manager do a quick review. They're going to speak with the MRT (medication reconciliation tech) who completed the PTA (prior to admission) medications when he comes in at 1400. However she said there is a record of a prescription filled at the pharmacy for this patient. (Pharmacy Director) 09/27/23-Received letter addressed to (staff name) today as well as the previous letter attached. Called (Patient #18's husband) to confirm we received his letter and apologized for the perceived lack of follow-up. A call with (MD name) to discuss concerns was set up for today between 2-4 p.m. ..." Review of the notes recorded the call took place and the husband wanted to know what happened and what actions were taken to fix the problem and keep it from happening again. Review revealed the husband requested an in-person meeting. Continued documentation of the notes revealed, "... 10/04//23 - This case was reviewed by the Pharmacy Director and Manager of Pharmacy Technical Services. ... We will be submitting an Encompass Idea for (name of contract vendor). However, (name of contract vendor is a 3rd party vendor contracted through (name of electronic medical record company), not (name of hospital) so we don't have any influence over this program. ... (Name) is the MRT manager. She is reaching out to (corporate contacts) to determine what processes their Med Rec Techs use to establish competency for interview. I don't believe it is reasonable to expect the MRT to assess cognitive function, so we may need to have an interdisciplinary team to determine who can assess the patient, what patient needs the assessment, and how this can be communicated to the MRT team. ...10/10/23- An in person meeting was held with (Patient #18's) husband, (names of key staff members). (Name Director of Pharmacy) explained how the medication appeared to be in the patient's list. She also explained that the Med Rec Tech spoke with the patient, and it is documented that she said she was taking the medication. (Husband name) was happy about the explanation but had concerns regarding his wife being asked regarding her medications as she was in for Acute Metabolic Encephalopathy which causes confusion. We all agreed that there are opportunities with this process that we will start to work on. He was satisfied with the resolution and information given during the meeting. ..." Continued review revealed Patient #18's husband met with a group of hospital leaders on December 20, 2023 and discussed additional findings, "... (MD name) reviewed the complaint and acknowledged the gaps in the process that led to the medication error. He explained that (name of vendor) is a platform built into (name of electronic medical record system), and is a platform that only received information one way. Per his understanding, the community pharmacy listed the carvedilol on her medication list in error and removed it. However, the (name) platform accessed that information and did not "recognize" removal of that information. Therefore, when she was hospitalized, that medication showed up on her list in (electronic medical record program). (MD name) explained that this is a known issue. ... (Hospital name) has a number of containment strategies in place to avoid this error. ..." Review revealed a final Grievance response letter was sent to Patient #18's husband on 10/10/2023 (9 months after the medication error and 7 months after a grievance was filed).

Review of actions taken as a result of the grievance file investigation revealed the information from the patient's medication list collected electronically by the vendor that was in error was being escalated through corporate leadership to the vendor for an appropriate solution. Review of the actions taken received on 07/11/2024 included:
"1. New Process: Med Rec Techs to check in with primary RN prior to the med rec interview if the patient's cognitive status is questionable. (completed 10/23); 2. New Med Rec process note now includes confidence level - encourage care team (nursing, providers) to look at progress note to determine if additional review is needed when ordering/administering medications. (completed 10/23); 3. New Med Rec Tech Process: Implementing chart review (Assessment by RN, provider progress notes that day, ED (emergency department) H&P (History and Physical) etc.) for Med Rec Tech to identify AMS (Altered Mental Status) prior to completing Med Rec. (completed 11/23); 4. Educating Med Rec team on where GCS (Glasco Coma Scale), orientation scale (A&O x4 - alert and oriented times four), whether patient is poor historian; how to complete a quality chart review to determine if patient is appropriate to complete Med Rec interview accurately (completed 11/23); 5. New Med Rec Process: Add area in med tech process note to chart review was done (completed 2/23); 6. Communication (vendor) error to AVP of IAS Clinical Applications Management Team and Chief Information Officer - following up with (vendor name) to identify solution (completed 10/26/23); 7. Nursing Event Peer Review Referral - (completed 10/26/23); 8. Quality Assurance Improvement Committee (Medical/Provider Peer Review) - (completed 10/26/23)."

Interview on 07/11/2024 at 1145 with the manager of pharmacy tech services revealed there were no rosters of staff that completed the training regarding the new process for medication reconciliation. Interview revealed the training was done via MS TEAMS and in person around the first week in November 2023. Interview revealed all med rec techs were required to have the training and it was added to the onboarding for new med rec techs. Interview revealed there were quality medical record reviews done routinely since 2022 that included review of two per each med rec tech per month that were done in real time. Interview revealed there was no documentation of the monitoring of actions taken.

In summary, a medication error occurred in January 2023 with a medication error incident report documented. No actions were taken when the medication error incident report was reviewed. A grievance was filed in March 2023 and upon review, it was discovered that process changes were needed to prevent future medication errors. Actions were taken in October and November 2023 to improve processes related to medication reconciliation. No monitoring of those actions was documented. Review revealed a delay in making process improvements and monitoring those improvements.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on policy review, medical record reviews and staff interviews, nursing staff administered medication without following a physician's order to verify and hold the medication based on the patient's blood pressure and heart rate prior to administration for 3 of 6 sampled patients (Patient #38, #35, and #18).

Findings included:

Review of the facility's "Medication Administration Nursing" policy effective date 01/2023 revealed, "... I. POLICY This policy provides guidelines for medication administration in a safe manner following established policies and procedures. ... II. PERFORMED BY RN (registered nurse), LPN (licensed practical nurse), and other registered or certified professionals according to scope of practice or job description. ... IV. PREPARATION A. Review order, MAR (Medication Administration Record) and comments for special instructions and other parameters. ... VIII. Documentation ... B. Electronic MAR ... 3. Document as indicated for the medication (blood pressure, apical pulse, blood sugar, etc. ..."

1. Open medical record review on 07/11/2024 for Patient #38 revealed an 70 year-old male admitted on 07/05/2024 with a colovesicle fistula (an abnormal connection between the colon and bladder that can cause infection). Review of a physician's admission History and Physical dated 07/06/2024 at 1422 recorded the patient had a past medical history of type 2 diabetes, sleep apnea, depression, coronary artery disease, end stage renal disease on hemodialysis, chronic diastolic heart failure, hypertension, and multiple myeloma on chemotherapy. Review of physician's orders revealed an order dated 07/07/2024 at 0900 for "carvedilol (Coreg)(medication used to treat high blood pressure and heart failure) 25 milligrams (mg) two times daily. Hold for SBP (systolic blood pressure) less than 95 or heart rate less than 55. If dose is held, check heart rate and blood pressure Q 1HR X2 (every hour times two). If SBP greater than 95 and heart rate greater than 55, administer med. If not, call MD (medical doctor) for action." Review of the patient's electronic medication administration record (MAR) revealed Patient #38 was administered carvedilol 25 mg on 07/08/2024 at 1833. Record review revealed the last blood pressure and heart rate documented prior to administration of the carvedilol was on 07/08/2024 at 0800 (10 hours and 33 minutes prior to the medication administration).

Interview on 07/12/2024 at 1315 with RN #1 revealed she was the registered nurse that administered the carvedilol to Patient #38 on 07/08/2024 at 1833. Interview revealed the nurse was familiar with the medication and aware that the medication had parameters to hold the medication based on the patient's blood pressure and heart rate. The nurse stated the techs take the patient's vitals in the mornings and she stated she took the patient's vitals prior to administering the medication. The nurse reported she was "real careful with him (Patient #38) because he is on dialysis. Sometimes the (vital sign) machine acts out. His mentation was off that day." The nurse confirmed the last blood pressure or heart rate documented on the patient before she administered the carvedilol was at 0800. The nurse stated she wasn't sure why there was no blood pressure or heart rate readings documented on Patient #38 before she administered his carvedilol. She stated, "I don't like to give blood pressure medicine without checking the patient's blood pressure first."

Interview on 07/15/2024 at 1245 with the Chief Nurse Executive (CNE) revealed there was currently no policy in place defining a time frame to assess vital signs prior to medications that have hold parameters. The CNE stated she had reviewed the medical records for Patients #38, #35 and #18 and taking vital signs 4 hours or 8 hours prior to medication administration for meds that have hold parameters is not okay. She stated she was implementing vital signs are to be taken within 60 minutes of medication administration when hold parameters are ordered. Interview revealed nursing staff failed to evaluate the patient's vital signs as ordered prior to the medication administration.

2. Open medical record review on 07/11/2024 for Patient #35 revealed an 80 year-old male admitted on 07/08/2024 with shortness of breath and chest pressure. Review of a physician's History and Physical dated 07/08/2024 at 1022 recorded an assessment and plan that included, "Acute on chronic diastolic (congestive) heart failure ... Will diurese (process to excrete urine) patient, monitor vital signs, weight and intake and output closely. ... Primary hypertension - Continue home dose of ... carvedilol for heart failure ..." Review of physician's orders revealed an order dated 07/08/2024 at 1741 for "carvedilol (Coreg) 12.5 milligrams (mg) two times daily with meals. Hold for SBP (systolic blood pressure) less than 95 or heart rate less than 55. If dose is held, check heart rate and blood pressure Q 1HR X2 (every hour times two). If SBP greater than 95 and heart rate greater than 55, administer med. If not, call MD (medical doctor) for action." Review of the patient's electronic medication administration record (MAR) revealed Patient #35 was administered carvedilol 12.5 mg on 07/08/2024 at 1800. Record review revealed the last blood pressure and heart rate documented prior to administration of the carvedilol was at 1422 (3 hours and 38 minutes prior to the medication administration).

Interview on 07/12/2024 at 1400 with RN #2 revealed she was the registered nurse that administered the carvedilol to Patient #35 on 07/08/2024 at 1800. Interview revealed the nurse didn't remember the patient. The nurse stated she would "go by the most recent vital signs if they were done within the hour (prior to the carvedilol administration)." The nurse confirmed the most recent vital signs documented on Patient #35 were at 1422 prior to the administration of the Carvedilol at 1800. The interview revealed the nurse would expect the vital signs to be taken within 1 hour prior to administration of carvedilol.

Interview on 07/15/2024 at 1245 with the Chief Nurse Executive (CNE) revealed there was currently no policy in place defining a time frame to assess vital signs prior to medications that have hold parameters. The CNE stated she had reviewed the medical records for Patients #38, #35 and #18 and taking vital signs 4 hours or 8 hours prior to medication administration for meds that have hold parameters is not okay. She stated she was implementing vital signs are to be taken within 60 minutes of medication administration when hold parameters are ordered. Interview revealed nursing staff failed to evaluate the patient's vital signs as ordered prior to the medication administration.

3. Medical record review on 07/10/2024 for Patient #18 revealed an 77 year-old female admitted on 01/19/2023 with acute metabolic encephalopathy (brain dysfunction causing confusion) due to hypoglycemia (low blood sugar level). Review of a physician's History and Physical dated 01/19/2023 at 2335 recorded a history of urinary retention and erythromelagia (a rare vascular peripheral pain disorder usually in the lower extremities). Review revealed the patient had hypoglycemia of unclear etiology with a plan to monitor blood sugar levels. Review of physician's orders revealed an order dated 01/20/2023 at 1742 for "carvedilol (Coreg) 25 milligrams (mg) two times daily. Hold for SBP (systolic blood pressure) less than 95 or heart rate less than 55. If dose is held, check heart rate and blood pressure Q 1HR X2 (every hour times two). If SBP greater than 95 and heart rate greater than 55, administer med. If not, call MD (medical doctor) for action." Review of the patient's electronic medication administration record (MAR) revealed Patient #18 was administered carvedilol 25 mg on 01/20/2023 at 1749. Record review revealed the last blood pressure and heart rate documented prior to administration of the carvedilol was at 1556 (1 hour and 53 minutes prior to the medication administration). Review revealed the heart rate was recorded as 59 at 1556. Review of the patient's electronic medication administration record (MAR) revealed Patient #18 was administered carvedilol 25 mg on 01/21/2023 at 1029. Record review revealed the last blood pressure and heart rate documented prior to administration of the carvedilol was at 0719 (3 hours and 10 minutes prior to the medication administration). Review of the record revealed the heart rate was 51 (parameters to hold medication below 55) with a blood pressure of 117/80.

Interview on 07/11/2024 at 1100 with RN #3 revealed she was the registered nurse that administered the carvedilol to Patient #18 on 01/20/2023 at 1749 and on 01/21/2023 at 0719. Interview revealed the nurse didn't remember the patient. The nurse stated it was nursing judgement when to check the blood pressure and heart rate prior to administration of the carvedilol. She stated she would get the vitals within one hour and would re-check them if they were borderline. The nurse reviewed Patient #18's medical record and reported the vitals were documented on 01/20/2023 at 1556, over an hour prior to the medication administration with a heart rate of 59 (borderline. She stated, "I should have done a re-check." She reported the carvedilol was administered on 01/21/2023 at 1029 with vitals done at 0715 and a heart rate of 51, which was below the parameter to hold the medication. She stated, "The vitals were done 3 hours prior to the medication administration. I should have re-checked (the vitals)."

Interview on 07/15/2024 at 1245 with the Chief Nurse Executive (CNE) revealed there was currently no policy in place defining a time frame to assess vital signs prior to medications that have hold parameters. The CNE stated she had reviewed the medical records for Patients #38, #35 and #18 and taking vital signs 4 hours or 8 hours prior to medication administration for meds that have hold parameters is not okay. She stated she was implementing vital signs are to be taken within 60 minutes of medication administration when hold parameters are ordered. Interview revealed nursing staff failed to evaluate the patient's vital signs as ordered prior to the medication administration.

NC00215983, NC00215138, NC00212517, NC00207955, NC205152, NC00202881, NC00197457, NC00193890, NC00193330, NC00190916, NC00190514, NC00189076, NC00186441, NC00184941, NC00184738