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Based on observation, review of clinical records, review of facility policies and procedures, and interviews, the facility failed to honor patients' rights by failing to provide care in a safe setting including failure to ensure EKG (electrocardiogram) test results were reviewed for abnormalities and, when abnormalities are identified, ensure the results are communicated to the physician for possible interventions for three patients (#2, #7 and #9) of 6 patients reviewed for EKG results.

The hospital failed to report abnormal EKG results for three patients (Patient #2, #7, and #9), one of which (#2) died.. (refer to A0144) The noncompliance at the Condition of Participation of Patient Rights due to the hospital's failure to ensure that patients receive care in a safe setting resulted in Immediate Jeopardy. The Immediate Jeopardy began on 11/18/2022. The hospital was informed of the Immediate Jeopardy on 1/20/2023 at 2:30 p.m. and was ongoing as of the survey exit on 1/20/2023. On 1/19/23, 72 patients had EKG tests performed.

Cross reference to A0144

Based on observation, review of clinical records, review of facility policies and procedures, and interviews, the facility failed to provide patient care in a safe setting for three (Patient #2, #7 and #9) of six patients reviewed for nursing staff failing to review and report abnormal EKG (electrocardiogram) results. One patient (#2) with unidentified and unreported abnormal EKG results experienced cardiac arrest and died. Two other patients (#7 and #9) with unidentified and unreported abnormal EKG results did not experience adverse effects from the abnormality at the time.

The findings include:

The Critical Test Results and Values Policy and Procedure, effective date 5/10/2022 included the following: PURPOSE: To establish a mechanism for timely reporting of critical test results and values as defined by the medical staff. DEFINITIONS: Critical Test Results and Values: Critical test results and values are those results that require rapid communication of the results so the patients can be promptly treated. POLICY: A. All critical test results and values will be reported in a timely manner to the responsible provider. B. The Department of Cardiology, Laboratory, Radiology and Respiratory in collaboration with the Medical staff shall define: 1. Critical test results and values; 2. Reporting timeframes; 3. Measurement methodology. PROCEDURE: A. The technical or medical staff of Cardiology, Laboratory Radiology and Respiratory will convey critical test results and values via telephone or face-to face to: 1. Inpatient settings: a responsible provider, RN or LPN (Acute Care, Rehab). Algorithm for Cardiology; Defined Critical Test Results and Values 12 Lead ECG (Electrocardiogram)- 1. Ventricular Tachycardia -4 or more consecutive PVC's (premature ventricular contractions) 2. Long Pauses in Heart Rhythm (greater than 3.0 seconds). Reporting Flow Process - Cardiovascular Nurse/ sonographer/ Technologist to contact Responsible Provider; Reporting Timeframes - As soon as possible and not to exceed 45 minutes after being read.

The Pre-Procedure Testing for Patients Receiving Regional, MAC (managed anesthesia care) or General Anesthesia Policy and Procedure, effective date 8/16/2022 includes the following: PURPOSE: To provide testing guidelines for inpatients and outpatients who will receive regional, MAC, or general anesthesia for invasive or non-invasive procedures. POLICY: Pre-procedure testing will be determined after a review of patient history and type of procedure to be performed. PROCEDURE: 1. The patient scheduled for a procedure should have the following tests: Algorithm designated EKG for patient category including : age over 60 years; Cardiac Disease (MI- myocardial infarct (heart attack), CHF- congestive heart failure, Pacemaker/AICD (Automated Implantable Cardioverter Defibrillator); coronary stents; Pulmonary Disease (active COPD- chronic obstructive pulmonary disease, asthma, CHF, within one month previous abnormal); Diabetes; Hypertension; Morbid Obesity BMI (Body Mass Index) 50 or over; ESRD (End Stage Renal Disease) on Hemodialysis; Vascular Disease; Chemotherapy; Cardio/ Thoracic Surgery; OSA (Obstructive Sleep Apnea); Thyroidectomy, Radical Prostatectomy, Nephrectomy, CEA (carcinoembryonic antigen), AAA (abdominal aortic aneurysm) Fem/ Pop (Femoral Popliteal) Bypass; Drug and Alcohol Abuse. 2. All abnormal test results will be reviewed and addressed by the ordering physician when resulted.

The Pre-Procedure/Surgical Checklist and Assessment - Adult Policy and Procedure, effective 4/13/2021 includes the following: PURPOSE: To assure appropriate diagnostic tests, medication, assessment, treatments, and safety procedures are completed and documented in the electronic health record (EHR) prior to surgery/procedure.

The Assessment/Pre-Procedure Interview and Testing Policy and Procedure, effective 5/10/2021 included the following: PURPOSE: To establish assessment and interview criteria for patients undergoing Surgery/Procedures required for both inpatient and outpatients who will receive Regional, MAC or General anesthesia for invasive or non-invasive procedures. The guidelines will provide consistency of care for most patients and allow the physician to determine further studies based on their assessment of the patient. POLICY: All patients will be interviewed and needs assessed by an RN (Registered Nurse) prior to procedures requiring anesthesia. PROCEDURE: 2. Labs, EKG, CXR (chest x-ray) will be completed per surgeon/anesthesia orders. Anesthesia/ordering physician will be notified of abnormal results.

The Pre-Procedure Guide dated 2/27/2020 requires EKG for patient greater than 50 years or with cardiac history.

1. Review of hospital clinical records for Patient #2, a 70-year-old woman, admitted to the hospital general medical/surgical floor from the emergency room on 11/16/2022 for abdominal pain and diarrhea. After radiology testing, physician assessment and surgical consult, patient #2 was recommended to have surgery. Patient #2 was scheduled for a cholecystectomy (surgical procedure to remove the gallbladder) to be performed on 11/18/2022. On 11/18/2022 RN Staff A obtained a pre-operative EKG at 6:17 a.m. per pre-procedural checklist. The obtained EKG results printout documented, "Abnormal ECG (a.k.a. EKG); Heart Rate 88 beats per minute; Sinus Rhythm; Ventricular premature complex; Anterolateral infarct, acute vs recent; ST elevation, consider inferior injury." The printout results, indicating serious cardiac event, was placed in Patient #2's chart without review. The results of the abnormal EKG were not communicated to the physician or communicated to the oncoming 11/18/2022 dayshift nurse. The EKG was electronically signed by the physician on 11/18/2022 at 5:03 p.m., ten hours after EKG testing was completed. On 11/18/2022 Patient #2 deteriorated and the MET (Medical Emergency Team) was called at 9:48 a.m. RN Staff B and the physician were at bedside. Lab work was ordered, and a repeat EKG completed at 11:01 a.m., 4 hours and 44 minutes after the initial EKG with abnormal results. The 11:01 a.m. EKG results showed, "Abnormal EKG, sinus tachycardia; rate greater than 99; Right bundle branch block; Probable anterolateral infarct, acute; Probable acute inferior infarct" indicating Patient #2 was having a hear attack. Lab work resulted at 11:36 a.m. Lactic Acid was 5.8, high, with normal reference range 0.5 to 1.9 mmol/L, indicating low oxygen to the muscle tissue. At 12:27 p.m., the lab results for Troponin level was greater than 25,000, high, with normal reference range 0 to 0.04 ng/ml (globular protein involved in muscle contraction elevated when a heart attack occurs). At 12:39 p.m. a Code STEMI (ST Elevation Myocardial Infarction) was initiated (resuscitation for a heart attack). At 12:50 p.m. a repeat EKG results documented "Abnormal EKG; Sinus Tachycardia; Probable anterolateral infarct, acute; ST elevation, consider acute inferolateral infarct." At 1:04 p.m. cardiology consult at bedside ordered transfer of patient to another facility for cardiac catheterization (insertion of a narrow tube into the heart through an artery to examine how well the heart is functioning). At 1:24 p.m., Patient #2 had a Code Blue event. Full resuscitative efforts attempted and unsuccessful. Patient #2 died at 1:42 p.m. on 11/18/2022, seven hours and twenty-five minutes after the initial abnormal EKG.

2. Review of clinical records for Patient #7, a 60-year-old woman, showed the patient was admitted to the hospital on 1/13/2023 from the emergency room for abdominal pain and abdominal distention. After work up and testing it was determined Patient #7 had a small bowel obstruction that did not improve with rest. There medical team decided the patient needed surgery and set the surgical date for 1/16/2023. The patient had a pre-operative EKG which showed sinus Bradycardia (slower than expected heart rate, generally beating fewer than 60 beats per minute) at a rate of 57 beats per minute. Review of physician notifications showed the physician was not notified of the patient's slow heart rate. Patient #7 did not have a diagnosis of Bradycardia documented in the clinical records.

3. Review of clinical records for Patient #9, a 70-year-old male, admitted to the hospital on 1/15/2023 with admitting diagnosis of Cholecystitis (inflammation of the gallbladder). An EKG completed in the emergency room on 11/15/2023 at 1:03 p.m. documented, "Abnormal ECG; heart rate 78; sinus rhythm; Probable left atrial enlargement; nonspecific intraventricular conduction delay, probable anterolateral infarct, age indeterminate; abnormal T wave, consider Ischemia diminished blood supply to any tissue or organ of the body, causing a shortage of oxygen), lateral leads." A repeat EKG conducted as inpatient on 1/16/2023 at 11:29 a.m., prior to surgery, documented, "Abnormal EKG; heart rate 131 beats per minute; Atrial flutter with varied AV (artrioventricular) block; Left axis deviation; ST depression (heart's electrical signal/rhythm made up of five waves designated P, Q, R, S, T- ST segment appears abnormally low indicates severe coronary lesions), consider Ischemia inferior leads; Prolonged QT interval (measured interval Q to T spread widened out of normal range)." Review of the physician notifications showed the physician was not notified of the abnormal EKG.

On 1/17/2023 at 11:26 a.m. during an interview, Risk Manager Staff C confirmed that the hospital did not have a specific policy for abnormal EKG reporting. She said it is part of the nursing assessment to report anything abnormal, for example if the Blood Pressure was 200/110 mmHg then they would need to report to the physician.

On 1/17/2023 at 11:50 a.m., RN Staff D was interviewed about the EKG process. He said Certified Nursing Assistants (CNAs) do the majority of the EKGs, but the nurses can do them also. RN Staff D said patients had to have an EKG pre-operatively. He said the CNA completes the EKG and gives the paper rhythm strip printout to the nurse, who reviews the results. RN Staff D stated, "We aren't cardiac nurses but if there was something abnormal then we notify the MD". RN Staff D was unable to specify what results would be abnormal for which he would contact the physician.

On 1/17/2023 at 12:40 p.m. during an interview, RN charge nurse Staff E confirmed Patient #7 had an EKG prior to surgery. Patient #7's EKG printout was reviewed with RN Staff E and was asked if the physician had been notified about the sinus Bradycardia results. RN Staff E looked in the patient's clinical records and said, "I don't see any notifications. Her heart rate runs low so I don't think it is anything to be concerned about. She has been mostly in the 60's and 70's heart rate since she has been here." RN Staff E confirmed that the patient did not have a documented history of lower heart rates." RN Staff E confirmed she did not have a reference as to what abnormal EKG results needed to be communicated to the physician.

On 1/18/2023 at 1:20 p.m. during an interview, Risk Manager Staff F said, regarding Patient #2, the assigned nurse should have reviewed the results of the EKG and communicated immediately with the physician. The Risk Manager confirmed that the critical values policy does not adequately address abnormal EKG values which need to be communicated to the physician. She stated, "Not every abnormal result is going to get called to a doctor."

On 1/18/2023 at 2:50 p.m., the physician assigned to Patient #2 on 11/18/2022 (date of her death) was interviewed. The physician said he remembered the patient, and it was the first time he was assigned to cover her. He said he got a call from RN Staff B who said she could not get an oxygen reading and that she was going to call the MET team. RN Staff B said the patient was put on 2 liters of oxygen during the night shift the past night because the nursing staff could not get a good reading on the pulse oximeter (a noninvasive test that measures the oxygen saturation level of the blood). The physician said he knew something was wrong since it would not make sense for a Cholecystitis patient to suddenly need oxygen. He said he started the work up thinking maybe she was septic or something. He said when he saw the EKG, he saw it was different from baseline and thought it was right STEMI. He ordered lab tests for lactic acid and troponins. When they got those results, they started the transfer process for cardiac catheterization. The physician said this should not have been missed and should have been noticed on the night shift when the EKG was done. The physician stated, "I don't know if it would have made any difference since it was a complete blockage but who knows". The physician said he is not always notified for abnormal EKGs. He said, " When I come in, I double check all of the labs and results for my patients. If I place an order for imaging or anything else, they should notify me if the results are abnormal. I know not every doctor feels that way, but I do. Why order a pre-op EKG if you're not going to look at it."

On 1/18/2023 at 3:05 p.m., RN Staff B who was caring for Patient #2 on 11/18/22 was interviewed. RN Staff B confirmed that Patient #2 was scheduled for surgery on 11/18/22. She said the night nurse RN Staff A never said anything about an abnormal EKG and she did not look at the results since it was already completed and placed in the chart as part of pre-op. RN Staff B said during the cardiac event the EKG was repeated which showed the patient was having a heart attack. She said the patient died before she could be transfer to the other campus for cardiac catheterization. RN Staff B said it is the policy that any patient over 50 years old gets a pre-op EKG.

On 1/19/2023 at 10:20 a.m., RN Staff A who was assigned to care for Patient #2 on the 11/17/2022 nightshift was interviewed. RN Staff A said since the patient was having surgery there is a list of routine things to do. RN Staff A said around 10:00 p.m. to 11:00 p.m., she asked the CNA to do the EKG on Patient #2. RN Staff A said she realized towards the end of the shift that the EKG had not been done so she quickly did it at 6:17 a.m. RN Staff A stated, "Thinking it was routine I did not look at the EKG. Looking back, I should have looked at it. I just put it away in the chart." Speaking about the EKG process, RN Staff A said the CNAs usually do the EKG,. RN Staff A remarked, "Sometimes they bring the paper to the nurse and sometimes they don't it depends on the CNA". RN Staff A further stated, "I have only had a handful of routine EKGs since starting April 2022. Typically, I don't look at the EKG paper. I assumed the physician would go and look at them."

On 1/19/2023 at 3:00 p.m. in an interview, the Risk Manager Staff F, discussing the EKG process, said, "There is still a challenge with whether or not to do the EKG. Our policies need revision, and we need to have a clear plan for taking EKGs and for reporting the results. Which we don't have now."

On 1/20 /2023 at 12:30 p.m. in an interview, the Vice President of Operations/Chief Physician Executive said regarding the EKG process, "There, currently, is not a clear path for results to be reported by the staff. Sometimes the results are not read by cardiology and that piece might be missing. There are so many things going into play and that the decision to receive reports falls to the provider". The Chief Physician Executive further said, "I think we need to move to the physician and escalate in the right direction. Our policies will need to be revised to ensure we are identifying and addressing abnormal results".

On 1/20/2023 at 1:20 p.m., EKG Technician Staff G was interviewed about the process for EKGs. She said training included 2 weeks with a manager and supervisor. She said she was taught how to do an EKG and taught a bit about the rhythms. EKG Technician Staff G said, "The process is I get the order, go upstairs, print out the EKG, and give the printout to the nurse sometimes but not always. If I don't see anything critical, then I put it in the chart. We look at the old EKGs and use our judgement to decide if the EKG is something that needs to be escalated." EKG Technician Staff G said it could be hours before a nurse looks at the results. EKG Technician Staff G confirmed she completed the pre-op EKG for Patient #7 and Patient #9. She reviewed the printouts and said, "I would have put them in the chart and not given them directly to the nurse."

On 1/20/2023 at 1:30 p.m., RN Staff H who cared for Patient #7 on 1/16/23, when the EKG was performed was interviewed. RN Staff H said she had no idea about the Bradycardia and said that she does not routinely go check the EKGs done before surgery. She said there is not any guidance available for when to contact the physician.

Based on record review, interviews, review of facility documents, and review of policy and procedure, the hospital failed to ensure that clear expectations for patient safety were implemented by the Quality Assurance and Performance Improvement (QAPI) Program. The QAPI system failed to ensure a complete and thorough investigation of a serious sentinel event involving patient death relating to EKG (electrocardiogram) testing on 11/18/22 for one patient (Patient #2). The facility also failed to implement effecting staff education for reporting abnormal EKG results and failed to have consistent policies for addressing abnormal EKG results including physician notification of abnormal results.

The condition is not met due to the systemic failure to maintain a functioning QAPI system to investigate, track and trend, and implement measures to ensure a lack of nursing review of EKG reports and lack of reporting abnormal results to a physician leading to a serious sentinel event does not occur. A patient (#2) died several hours after having an abnormal EKG which was not reviewed or reported to a physician. The initial investigation did not audit any other patients with EKGs to see if all abnormal results were addressed appropriately, nor did the investigation determine if all nurses are reviewing EKG results when obtained. The hospital leadership has not educated the staff as to how to address abnormal EKG results and has not developed policies for reviewing and reporting abnormal EKG results. The noncompliance at the Condition of Participation of QAPI due to the hospital's failure to have an effective QAPI program resulted in Immediate Jeopardy. The immediate Jeopardy began on 11/18/2022. The hospital was informed of the Immediate Jeopardy on 1/20/2023 at 2:30 p.m. and was ongoing as of the survey exit on 1/20/2023. Other patients who require EKG testing have a likelihood of serious harm or death due to the hospital's ineffective QAPI program. On 1/19/23, 71 inpatients had EKGs performed. (Refer to A0286, A0144, A0395).

Based on record review, staff interview,review of clinical records, and review of facility policies and procedures the facility failed to effectively investigate an adverse incident and failed to develop and implement a performance improvement plan (PIP) with effective preventive actions for the adverse incident event reviewed for Patient #2. The facility could not ensure EKG (electrocardiogram) technicians and nursing personnel were following the requirements for patient care in a safe setting regarding reporting abnormal EKG results to prevent likely or actual serious harm or death to patients. Cross reference A0263..

The findings include:

Reporting Adverse Incident Policy and Procedure effective 3/22/2022 includes the following: PURPOSE: to provide guidelines for reporting Adverse Incidents in accordance with Florida law. POLICY: Florida Law requires the reporting of adverse incidents. The Risk Managers shall create Adverse Incident Reports in accordance with Florida Law. PROCEDURE: A. An adverse incident is an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which result in one of the following conditions: 1. Death; 2. Brain or spinal cord injury; 3. Surgical procedure on the wrong patient; 4. Performance of the wrong surgical procedure; 5. Wrong site surgical procedure; 6. Performance of a surgical procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition; ...D. When to report: (3) Certain types of adverse incidents known as Code 15 (The report that a hospital must make to the Agency for Health Care Administration for an adverse incident, according to Florida law) must be reported to the State within 15 days whether occurring in the hospital or arising from health care prior to admission. Immediate telephone notification of Risk Management / Legal Services is required for the following injuries or events resulting from an event over which health care personnel could exercise control, and which is associated with in whole or in part with medical intervention, rather than the condition for which such intervention occurred. (a) The death of the patient. .... F. Management Follow up Risk Management will collaborate with leadership staff to determine an appropriate follow-up plan.

On 1/18/23 records review of Patient #2 was completed with Risk Manager Staff F. Patient #2 was admitted to the facility on 11/16/2022 for abdominal pain and diarrhea. The Patient was diagnosed with Cholecystitis (inflammation of the gallbladder) and scheduled for surgery on 11/18/2022. On 11/18/22 at 6:17 a.m. an EKG was completed as part of pre-operative procedures by Registered Nurse (RN) Staff A on the Medical/Surgical unit. The EKG printout of results said, "Abnormal ECG (also known as EKG). Sinus Rhythm, Ventricular Premature complex, anterolateral infarct acute vs recent, ST elevation, consider inferior injury." (These results indicate a serious cardiac event.) Registered Nurse Staff A who completed the EKG, placed the report in the patient's chart but did not review the printed report and did not communicate the abnormal results to the physician. On 11/18/2022 at 09:48 a.m., RN Staff B was unable to obtain pulse oximetry (blood oxygen saturation rate) on Patient #2 and contacted the MET (Medical Emergency Team) calling for the CCO (Critical Care Outreach) Nurse to assess the patient with the physician at bedside. Patient #2's condition deteriorated. On 11/18/2022 at 11:01 a.m. a repeat EKG was done. The results stated, "Abnormal ECG, Sinus tachycardia; heart rate greater than 99 beats per minute; Right Bundle Branch Block; Probable anterolateral infarct, acute; Probable acute inferior infarct" indicating the patient was having a heart attack. On 11/18/2022 at 12:27 p.m. received lab results: Troponin (globular protein involved in muscle contraction elevated when a heart attack occurs) > 25,000 reference normal 0 - 0.04 ng/ml. The lab results indicated an acute cardiac event was occurring. On 11/18/2022 at 12:50 p.m. the EKG was repeated showing abnormal results. The physician ordered the patient to be transferred to another facility for a cardiac catheterization (insertion of a narrow tube into the heart through an artery to examine how well the heart is functioning). On 11/18/2022 at 1:24 p.m., before the patient could be transferred, Patient #2 experienced a CODE BLUE cardiac arrest. Resuscitative efforts failed and on 11/18/2022 at 1:42 p.m. Patient #2 died.

On 1/18/2023 records review of Patient #7 was completed with Risk Manager Staff F. Patient #7, a current inpatient, had an EKG completed on 1/16/2023 at 8:01 a.m. prior to inpatient surgery. The EKG results documented sinus Bradycardia (slow heart rate below normal minimum of 60 beats per minute) at a heart rate of 57 beats per minute. There is no nursing documentation of Bradycardia noted in the patient's record, and no documentation of communication with the physician about the result. The EKG report was placed in the patient's record and reviewed by the physician after 2 hours. Risk Manager Staff F said that not all Bradycardia needs to be reported to the physician. The Risk Manager confirmed there is no clear guidance for the nursing staff as to what abnormal results should be communicated to the physician and which do not require the contact. This patient had no adverse outcome.

On 1/18/2023 records review of Patient #9 was completed with Risk Manager Staff F. Patient #9, a current inpatient, had an EKG on 1/16/2023 at 11:29 a.m. The results printout documented, "Abnormal ECG; Atrial Flutter with varied AV block (atrioventricular); Left axis deviation; ST depression (heart's electrical signal/rhythm made up of five waves designated P, Q, R, S, T ST segment appears abnormally low indicates severe coronary lesions), consider Ischemia (diminished blood supply to any tissue or organ of the body, causing a shortage of oxygen), inferior leads; prolonged QT interval (measured interval Q to T spread widened out of normal range)." There is no nursing documentation of an abnormal EKG noted in the patient's record, and no documentation of communication with the physician about the result. The EKG report was placed in the patient's record and reviewed by the physician after 4 hours and 45 minutes. This patient had no adverse outcome.

On 1/17/2023 at 2:25 p.m. the Risk Manager Staff C was interviewed about the sentinel event involving Patient #2. Risk Manager Staff C said the original Patient Safety Report for the event on 11/18/2022 was vague and did not include that the first EKG at 6:17 a.m. had not been reviewed or reported to the physician. Due to the vagueness of the Patient Safety Report, the event was not identified as requiring an escalation to Risk Management for review and possible initiation of a Code 15 report. During a routine review of patient safety events, the severity of the 11/18/2022 event was identified and communicated to Risk Management on 12/29/2022. Risk Management submitted a Code 15 report as required on 1/10/2023. The Risk Manager described the initial investigation, completed by the Department Director, as focused on the individual nurse and the individual patient. There was no investigation at the time of the event of the implications for other patients with abnormal EKG results.

On 1/19/2023 at 9:30 a.m., the Nursing Director for 2 East and 2 West was interviewed regarding the death investigation conducted for Patient #2 on 11/18/2022. The Nursing Director said the investigation focused on the one nurse who did not review the EKG and therefore did not know the physician needed to be notified. The Nursing Director said she did not look at any other patient EKGs to ensure no other abnormal results were missed. She said on 11/30/2022 there was a more in-depth look at the investigation of the event but no other patient records were reviewed. The Nursing Director stated, "We did not think it was a process issue or system issue." The Critical Results and Values policy was reviewed with the Nursing Director. She stated, "The policy is very limited as to what the nurse should report. It is something we need to reconcile." In describing the Nursing Director responsibility for serious event investigation and reporting, the Nursing Director said her responsibility is getting the safety report completed, quality reviews, and then notify risk management. She said the person completing the investigation and the Risk Manager then have a call to discuss and determine if a RCA (Root Cause Analysis) is needed. She said the response to this event took so long, from 11/18 /2022 to 12/29/2022 for two reasons: The submitted safety report was vague in not stating the EKG report was not reviewed; Secondly, the quality department reviewer was not triggered to think the missed reading of the EKG and not notifying the physician was significant.

On 1/19/2023 at 12:15 p.m., the Nursing Director Intensive Care Unit (ICU), the assigned lead for RCA involving Patient #2 death on 11/18/22, was interviewed. She said the risk management team had a fact finding call on 1/3/2023 to plan for the RCA. The team felt this was a "one off" event with a newer nurse dealing with a patient that was vomiting and she did not look at the EKG report. The Nursing Director ICU said the next step in the RCA was to identify the participants. She said the first meeting to review the RCA after fact finding is scheduled for 1/26/23. Nursing Director ICU confirmed they did not look at the records of other patients having EKGs. She said they did not investigate if other staff are not reviewing the EKGs when done and not notifying physicians of abnormal results. She acknowledged the facility does not have clear guidance for staff as to when to contact the physician for an abnormal EKG.

On 1/19/2023 at 3:00 p.m. in an interview, Risk Manager Staff F said concerning the EKG process, "There is still a challenge with whether to do the EKG. Our policies need revision and we need to have a clear plan for taking EKGs and for reporting the results, which we don't have now." She acknowledged the investigation for this event was lacking even prior to risk management being aware of the event.

On 1/20 /2023 at 12:30 p.m. in an interview, the Vice President of Operations/Chief Physician Executive said regarding the EKG process, "There, currently, is not a clear path for results to be reported by the staff. Sometimes the results are not read by cardiology and that piece might be missing. There are so many things going into play and that the decision to receive reports falls to the provider". The Chief Physician Executive further said, "I think we need to move to the physician and escalate in the right direction. Our policies will need to be revised to ensure we are identifying and addressing abnormal results".

Based on observation, clinical record review, review of facility policies and procedures, and interviews, the facility failed to ensure Registered Nurses were reviewing EKG (electrocardiogram) results for abnormalities and communicating abnormal results to the physician in a timely manner. This lack of supervision resulted in a delay in review of EKG results and no physician notification of abnormal EKG results for Patient #2 on 11/18/2022 at 6:17 a.m. During this delay the patient's serious cardiac condition was not detected. Patient #2's condition deteriorated. The serious cardiac condition was identified with a repeat EKGs at 11:01 a.m. (4 hours and 43 minutes after the initial EKG was performed) and at 12:50 p.m. Patient #2 coded and died on 11/18/2022 at 1:42 p.m. On 1/17/2023 records reviewed for Patient #7 revealed on 1/16/2023 the patient had a pre-operative EKG which showed sinus Bradycardia (slower than expected heart rate, generally beating fewer than 60 beats per minute) with a rate of 57 beats per minute. Review of physician notifications showed the physician was not notified of the slow heart rate. Patient #7 did not have a diagnosis of Bradycardia documented in clinical records. There was no adverse outcome. Also, on 1/17/2023 records reviewed for Patient #9 revealed a pre-operative EKG printout on 1/16/2023 at 11:29 a.m. documented, "Abnormal EKG; heart rate 131 beats per minute; Atrial flutter with varied AV (atrioventricular) block; Left axis deviation; ST depression (heart's electrical signal/rhythm made up of five waves designated P, Q, R, S, T ST segment appears abnormally low indicates severe coronary lesions), consider Ischemia (diminished blood supply to any tissue or organ of the body, causing a shortage of oxygen) inferior leads; Prolonged QT interval (measured interval Q to T spread widened out of normal range)." Review of the physician notifications showed the physician was not notified of the abnormal EKG. There was no adverse outcome.

There was inadequate nursing oversight and a lack of nursing protocols for the reviewing and notification of abnormal EKG results. (Refer to A0286, A0395, and A0144)

The hospital's noncompliance with the Conditions of Participation of Nursing Services due to the hospital's failure to provide appropriate nursing oversight resulted in Immediate Jeopardy. The Immediate Jeopardy began on 11/18/2022. The hospital was informed of the Immediate Jeopardy on 1/20/2023 at 2:30 p.m. and was ongoing as of the survey exit on 1/20/2023. On 1/19/2023 there were 71 inpatient EKGs performed. Cross Reference to A0115 and A0263.

Based on observations, records review, interviews, and hospital policy review the hospital failed to ensure a Registered Nurse (RN) evaluated the care provided to patients in regard to reviewing the results of EKGs (electrocardiogram) performed by the RN or an EKG Technician on patients in the care of the RN. This lack of Registered Nurse reviewing EKG results and lack of communication with the Physician of abnormal results affected three patients (Patient #2, #7, and #9) of six inpatients sampled who had EKG tests performed. Patient #2 deteriorated over the next several hours after an EKG with abnormal results was performed but not reviewed and results not reported to the physician , suffered a cardiac arrest, and died. Two additional patients (#7 and #9) had abnormal EKG results which were not communicated to the physician. Both patients did not experience any adverse effects of the abnormality at the time. Cross reference A0385.

The findings include:

The Critical Test Results and Values Policy and Procedure, effective date 5/10/2022 included the following: PURPOSE: To establish a mechanism for timely reporting of critical test results and values as defined by the medical staff. DEFINITIONS: Critical Test Results and Values: Critical test results and values are those results that require rapid communication of the results so the patients can be promptly treated. POLICY: A. All critical test results and values will be reported in a timely manner to the responsible provider. B. The Department of Cardiology, Laboratory, Radiology and Respiratory in collaboration with the Medical staff shall define: 1. Critical test results and values; 2. Reporting timeframes; 3. Measurement methodology. PROCEDURE: A. The technical or medical staff of Cardiology, Laboratory Radiology and Respiratory will convey critical test results and values via telephone or face-to face to: 1. Inpatient settings: a responsible provider, RN or LPN (Acute Care, Rehab). Algorithm for Cardiology; Defined Critical Test Results and Values 12 Lead ECG- 1. Ventricular Tachycardia (4 or more consecutive PVC's premature ventricular contractions) 2. Long Pauses in Heart Rhythm (greater than 3.0 seconds). Reporting Flow Process - Cardiovascular Nurse/sonographer/Technologist to contact Responsible Provider; Reporting Timeframes - As soon as possible and not to exceed 45 minutes after being read.

The Pre-Procedure Testing for Patients Receiving Regional, MAC (managed anesthesia care) or General Anesthesia Policy and Procedure, effective date 8/16/2022 includes the following: PURPOSE: To provide testing guidelines for inpatients and outpatients who will receive regional, MAC, or general anesthesia for invasive or non-invasive procedures. POLICY: Pre-procedure testing will be determined after a review of patient history and type of procedure to be performed. PROCEDURE: 1. The patient scheduled for a procedure should have the following tests: Algorithm designated EKG for patient category including : age over 60 years; Cardiac Disease (MI- myocardial infarct (heart attack), CHF- congestive heart failure, Pacemaker/AICD (Automated Implantable Cardioverter Defibrillator), coronary stents); Pulmonary Disease (active COPD- chronic obstructive pulmonary disease, asthma, CHF, within one month previous abnormal); Diabetes; Hypertension; Morbid Obesity BMI (Body Mass Index) 50 or over; ESRD (End Stage Renal Disease) on Hemodialysis; Vascular Disease; Chemotherapy; Cardio/Thoracic Surgery; OSA (Obstructive Sleep Apnea); Thyroidectomy, Radical Prostatectomy, Nephrectomy, CEA (carcinoembryonic antigen), AAA (abdominal aortic aneurysm) Femoral Popliteal Bypass; Drug and Alcohol Abuse. 2. All abnormal test results will be reviewed and addressed by the ordering physician when resulted.

The Pre-Procedure/Surgical Checklist and Assessment - Adult Policy and Procedure, effective 4/13/2021 includes the following: PURPOSE: To assure appropriate diagnostic tests, medication, assessment, treatments, and safety procedures are completed and documented in the electronic health record (EHR) prior to surgery/procedure.

The Assessment/Pre-Procedure Interview and Testing Policy and Procedure, effective 5/10/2021 included the following: PURPOSE: To establish assessment and interview criteria for patients undergoing Surgery/Procedures required for both inpatient and outpatients who will receive regional, MAC or General anesthesia for invasive or non-invasive procedures. The guidelines will provide consistency of care for most patients and allow the physician to determine further studies based on their assessment of the patient. POLICY: All patients will be interviews and needs assessed by an RN (Registered Nurse) prior to procedures requiring anesthesia. PROCEDURE: 2. Labs, EKG, CXR (chest x-ray) will be completed per surgeon/anesthesia orders. Anesthesia/ordering physician will be notified of abnormal results.

The Pre-Procedure Guide dated 2/27/2020 documented EKG test for patient greater than 50 years or with cardiac history.

1. Review of hospital clinical records for Patient #2, a 70-year-old woman, admitted to the hospital to the general medical/surgical floor from the emergency room on 11/16/2022 for abdominal pain and diarrhea. Patient #2 was scheduled for cholecystectomy (surgical procedure to remove the gallbladder) on 11/18/2022. On 11/18/2022, RN Staff A obtained a pre-operative EKG at 6:17 a.m. per the hospital pre-procedural checklist. The obtained EKG results documented, "Abnormal ECG (a.k.a. EKG); Heart Rate 88 beats per minute; Sinus Rhythm; Ventricular premature complex; Anterolateral infarct, acute vs recent; ST elevation, consider inferior injury." The printout of these results indicating a serious cardiac event, was placed in Patient #2's chart without nursing review. The results were not communicated to the physician or the oncoming nurse for the dayshift on 11/18/2022. The initial EKG was electronically signed by the physician on 11/18/2022 at 5:03 p.m. ten hours after EKG testing was completed. On 11/18/2022, Patient #2 deteriorated, and the MET (Medical Emergency Team) was called at 9:48 a.m. by RN, Staff B. Lab work was ordered. A repeat EKG, completed at 11:01 a.m., showed, "Abnormal EKG, sinus tachycardia; rate greater than 99; Right bundle branch block; Probable anterolateral infarct, acute; Probable acute inferior infarct" indicating Patient #2 was having a heart attack. Patient #2 also had lab work results reported at 12:34 p.m.: Troponin (globular protein involved in muscle contraction elevated when a heart attack occurs) level was greater than 25,000, high, with normal reference range 0 to 0.04 ng/ml. Patient #2 had a Code Blue (resuscitation for a heart attack) event at 1:24 p.m. Full resuscitative efforts attempted were unsuccessful. Patient #2 died at 1:42 p.m. on 11/18/2022 seven hours and twenty-five minutes after the initial abnormal EKG.

2. Review of clinical records for Patient #7, a 60-year-old woman, showed the patient was admitted to the hospital on 1/13/2023 from the emergency room for abdominal pain and abdominal distention. After work up and testing it was determined Patient #7 had a small bowel obstruction that did not improve with rest and the medical team decided the patient needed surgery which was scheduled for 1/16/2023. Patient #7 had a pre-operative EKG which showed sinus Braycardia (slower than expected heart rate, generally beating fewer than 60 beats per minute) with a rate of 57 beats per minute. Review of physician notifications showed the physician was not notified of the patient's slow heart rate. Patient #7 did not have a diagnosis of Bradycardia documented in clinical records. There was no adverse outcome.

3. Review of clinical records for Patient #9, a 70-year-old male, admitted to the hospital on 1/15/2023 with admitting diagnosis of Cholecystitis (inflammation of the gallbladder). An EKG, completed in the emergency room on 11/15/2023 at 1:03 p.m., documented, "Abnormal ECG; heart rate 78; sinus rhythm; Probable left atrial enlargement; nonspecific intraventricular conduction delay, probable anterolateral infarct, age indeterminate; abnormal T wave, consider ischemia, lateral leads." A repeat EKG was performed as inpatient on 1/16/2023 at 11:29 a.m. in accordance with pre-operative protocols. The inpatient pre-op EKG results printout documented, "Abnormal EKG; heart rate 131 beats per minute; Atrial flutter with varied AV block; Left axis deviation; ST depression, consider Ischemia inferior leads; Prolonged QT interval." Review of the physician notifications showed the physician was not notified of the abnormal EKG. There was no adverse outcome.

On 1/17/2023 at 11:26 a.m. during an interview, Risk Manager Staff C confirmed that the hospital did not have a specific policy for EKG reporting. She said it is part of the nursing assessment to report anything abnormal, for example if the Blood Pressure was 200/110 mmHg then they would need to report to the Medical Doctor (MD).

On 1/17/2023 at 11:50 a.m., RN Staff D was interviewed about the hospital's EKG process. He said Certified Nursing Assistants (CNAs) do the majority of the EKGs, but the nurses can do them also. RN Staff D said patients had to have an EKG pre-op, the CNA gives the EKG paper rhythm strip printout to the nurse, who reviews the results. RN Staff D stated, "We aren't cardiac nurses but if there was something abnormal then we notify the MD." RN Staff D was unable to specify what results would be abnormal for which he would contact the physician.

On 1/17/2023 at 12:10 p.m., Certified Nursing Assistant Staff J was interviewed about the EKG process. The CNA said, "I run the EKG and then give the printout to the nurse so he/she can interpret it. Frankly, I am not sure what to look for on the EKG."

On 1/17/2023 at 12:40 p.m. during an interview, RN charge nurse Staff E confirmed Patient #7 had an EKG prior to surgery. Patient #7's EKG printout was reviewed with RN Staff E and was asked if the physician had been notified about the sinus Bradycardia results. RN Staff E looked in the patient's clinical records and said, "I don't see any notifications. Her heart rate runs low so I don't think it is anything to be concerned about. She has been mostly in the 60's and 70's heart rate since she has been here." RN Staff E confirmed that the patient did not have a documented history of low heart rates. RN Staff E confirmed she did not have a reference as to what abnormal EKG results needed to be communicated to the physician.

On 1/17/2023 at 12:50 p.m., RN Staff K was interviewed about the EKG process on the Medical/Surgical unit. She said the EKG is done prior to surgery as part of the pre-op protocol. RN Staff E said the nurses can enter the order for the EKG based on the protocol. RN Staff K said she was unclear about which abnormal EKG results she would contact the MD. RN Staff K said, "I am not sure, I would check with the charge nurse."

On 1/17/2023 at 1:05 p.m., RN Staff L was interviewed about Patient #9 who had a pre-operative EKG done on 1/16/2023 at 11:29 a.m. with abnormal results. RN Staff L said usually they would look for something in the patient's history, but upon reviewing the record, did not see any documentation. RN Staff L confirmed there was no documentation of physician notification for the abnormal EKG results. RN Staff L said, "Sometimes they discuss the results in rounds but then the information is not put into the system. We don't have a list, but we look at the previous EKGs and their history to decide what to call the MD with."

On 1/17/2023 at 3:20 p.m., Risk Manager Staff C was interviewed about abnormal results including Bradycardia for Patient #7. The Risk Manager said about ownership for an abnormal result and when to call the MD, "I would not want to make that determination either". She confirmed the policy is unclear and there is no guidance for nursing staff on communication of abnormal EKG results except for severe cardiac events.

On 1/18/2023 at 1:20 p.m. in an interview, Risk Manager Staff F said, regarding Patient #2, the assigned nurse should have reviewed the results of the EKG and communicated immediately with the physician. The Risk Manager confirmed that the Critical Values Policy does not adequately address abnormal values which need to be communicated to the physician. She stated, "Not every abnormal is going to get called to a doctor." She said the hospital will need to revise the policy.

On 1/18/2023 at 2:50 p.m. the physician assigned to Patient #2 on 11/18/2022 (date of her death) was interviewed. The physician said he got a call from RN Staff B who said she could not get an oxygen reading and that she was going to call the MET team. The physician said when he saw the EKG, he noted it was different from baseline and thought right STEMI (ST Elevation Myocardial Infarct - Heart Attack). I ordered lab tests for lactic acid and Troponin. The physician said this should not have been missed and should have been noticed on the night shift when the EKG was done at 6:17 a.m. The physician said he is not always notified for abnormal EKGs. The physician said, "If I place an order for imaging or anything else, they should notify me if the results are abnormal."

On 1/18/2023 at 3:05 p.m., RN Staff B who was assigned to care for Patient #2 on 11/18/22 dayshift was interviewed. RN Staff B confirmed that Patient #2 was scheduled for surgery on 11/18/22 and the night nurse RN Staff A never said anything about an abnormal EKG. RN Staff B said she did not look at the results since it was completed already as part of pre-op. RN Staff B said during the cardiac event, the EKG was repeated which showed the patient was having a heart attack and that the patient died before she could be transferred to the other campus for cardiac catheterization (insertion of a narrow tube into the heart through an artery to examine how well the heart is functioning). RN Staff B said it is the policy that any patient over 50 years old gets a pre-op EKG as part of the preoperative process.

On 1/19/2023 at 10:20 a.m., RN Staff A who was assigned to care for Patient #2 on the 11/17/2022 nightshift was interviewed. RN Staff A said since the patient was having surgery there is a list of routine things to do. RN Staff A said around 10:00 p.m. to 11:00 p.m., she asked the CNA to do the EKG on Patient #2. RN Staff A said she realized towards the end of the shift that the EKG had not been done so she quickly did it at 6:17 a.m. RN Staff A stated, "Thinking it was routine I did not look at the EKG. Looking back, I should have looked at it. I just put it away in the chart." Speaking about the EKG process, RN Staff A said the CNAs usually do the EKG,. RN Staff A remarked, "Sometimes they bring the paper to the nurse and sometimes they don't it depends on the CNA". RN Staff A further stated, "I have only had a handful of routine EKGs since starting April 2022. Typically, I don't look at the EKG paper. I assumed the physician would go and look at them."

On 1/19/2023 at 3:00 p.m. in an interview, the Risk Manager Staff F, discussing the EKG process, said, "There is still a challenge with whether or not to do the EKG. Our policies need revision, and we need to have a clear plan for taking EKGs and for reporting the results. Which we don't have now."

On 1/20 /2023 at 12:30 p.m. in an interview, the Vice President of Operations/Chief Physician Executive said regarding the EKG process there, currently, is not a clear path for results to be reported by the staff. She said sometimes the results are not read by cardiology and that piece might be missing. The Vice President said there are so many things going into play and that the decision to receive reports falls to the provider. She said, "I think we need to move to the physician and escalate in the right direction. Our policies will need to be revised to ensure we are identifying and addressing abnormal results".

On 1/20/2023 at 1:20 p.m., in an interview, EKG Technician Staff G discussing the EKG process said training includes 2 weeks with a manager and supervisor. She said she was taught how to do an EKG and a bit about the rhythms. EKG Technician Staff G said ," The process is I get the order, go upstairs, print out the EKG, and give to the nurse, sometimes but not always. If I don't see anything critical, then I put it in the chart. We look at the old EKGs and use our judgement to decide if the EKG is something that needs to be escalated." EKG Technician Staff G said it could be hours before a nurse looks at the results. EKG technician Staff G confirmed she completed the pre-op EKG for Patient #7 and Patient #9. She reviewed the printouts and said, "I would have put them in the chart and not given them directly to the nurse."

On 1/20/2023 at 1:30 p.m., RN Staff H who cared for Patient #7 on 1/16/23, the day of EKG was performed, was interviewed. She said she placed the EKG results in clinical record. She said she had no idea about the patient's Bradycardia and said that she does not routinely go check the EKG printouts done before surgery. RN Staff H confirmed that there is not guidance available for when to contact the physician or not about abnormal EKG results .