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ONE TRILLIUM WAY

CORBIN, KY 40701

GOVERNING BODY

Tag No.: A0043

Based on interview, record review, and review of facility policies, the Governing Body failed to be effective in governing the facility to prevent patient neglect. Review of Patient #2's medical record revealed the patient presented to the ED on 12/30/18 with a change in mental status. The facility failed to conduct a sepsis screening in accordance with facility policy. Subsequently, the facility failed to identify that the patient had signs and symptoms of sepsis and failed to take action based on the sepsis protocol. The facility admitted Patient #2 to the Behavioral Health Unit on 12/30/18 with diagnoses of Psychosis, Hypertension (high blood pressure), Urinary Tract Infection, and Tardive Dyskinesia. Although further review of Patient #2's medical record revealed the facility completed subsequent sepsis screenings after admission, the facility failed to identify that the patient had an infection, which resulted in the screenings being negative and no further action was taken. In addition, the facility failed to develop a plan to address/treat the patient's infection.

Further review of Patient #2's medical record revealed on 01/05/19 at approximately 6:10 PM, Patient #2 had chest pain. The facility failed to implement the facility's chest pain protocol and failed to develop a plan of care for the patient to address/treat/monitor the patient's chest pain. In addition, nursing staff notified Patient #2's physician that the patient's EKG and laboratory results were abnormal on 01/05/19; however, interview with the physician revealed she was not aware the test results "flagged" and thought they were in a "gray area." Subsequently, the physician stated she did not consult Cardiology for an assessment of the patient or ensure the chest pain protocol was implemented.

In addition, the patient had two other elevated Troponin levels on 01/06/19; however, there was no documented evidence that the patient's physician was notified.

On 01/08/19, Patient #2 collapsed in the shower and staff called a Rapid Response code at approximately 10:44 AM (a Rapid Response was to support hospital personnel outside the Emergency Department and Adult Critical Care Units with early intervention in adult inpatients or observation patients who demonstrated acute changes and/or were progressively deteriorating). However, staff did not respond and another Rapid Response was called at approximately 10:47 AM, followed by a Code Blue (a Code Blue is announced overhead when someone is not breathing and/or has no heartbeat) at 10:47 AM. Interviews revealed staff began CPR for Patient #2. However, the Emergency Department physician did not respond immediately to the Code Blue announcement, but had someone call to make sure he was needed before he responded. The Code Team began administering emergency medications at approximately 10:51 AM once the physician arrived. Patient #2 expired on 01/08/19 at 11:25 AM.

Interview with the CEO revealed he was aware of concerns regarding Patient #2's care at the facility and believed the facility had corrected the concerns. However, there was no documented evidence that the facility had taken action to address the deficient practice or was monitoring to ensure the deficiencies were corrected.

CHIEF EXECUTIVE OFFICER

Tag No.: A0057

Based on interview, record review, and review of facility policies, the Chief Executive Officer (CEO) failed to manage the hospital in an effective manner for one (1) of ten (10) patients (Patient #2). The CEO failed to ensure staff completed Sepsis Screenings/Protocols in accordance with facility policy; failed to ensure that physicians implemented the facility's chest pain protocol and that consultations were conducted as needed; failed to ensure physicians were notified of laboratory results; failed to ensure the Behavioral Health Unit developed plans of care for medical issues; and failed to ensure the facility's Quality Improvement Performance Improvement (QAPI) program was effective at identifying quality of care concerns and developing action plans to address the concerns.

The findings include:

Review of the facility policy titled, "Hospital Plan for the Provision of Patient Care," reviewed 11/19/18, revealed the president of the hospital would have necessary authority and responsibility to operate the facility in all its activities and departments, subject to such policies as may be adopted and such orders that may be issued by the Governing Board. The policy stated the President should act as the duly authorized representative of the Governing Board in all matters for which they have not designated some other person to act. The President would implement all policies and directives established by the Governing Board and work with the medical staff and all those concerned with the rendering of professional services to insure that the best possible care and services may be rendered to all patients.

1. Review of Patient #2's medical record revealed the patient presented to the facility's Emergency Department on 12/30/18 at 1:09 PM with complaints of increased depression, "found at church with no shoes, no socks and no coat today." Review of the triage sepsis screen revealed the patient had an "acutely altered mental status" and a heart rate above 90; however, without laboratory studies being conducted (blood glucose, White Blood Count (WBC), and BANDS), the triage nurse indicated Patient #2's sepsis screen was negative. Review of Patient #2's laboratory results dated 12/30/18 at 1:51 PM revealed the patient's WBC was elevated at 15.06 (normal range was 4.5-12.50 and greater than 12 is a possible sign of sepsis according to the facility's policy), Neutrophil % was 80.5 (normal range 30.0-70.0, an elevated level is an indicator of infection), and Glucose was 141 (normal range was 70-110 and greater than 140 was a sign of sepsis according to the facility's policy). Further review of laboratory results revealed the patient's urinalysis revealed the patient had two plus leukocytes (the presence indicates an infection). However, there was no documented evidence that staff completed another sepsis screening in the ED and/or identified the patient's signs and symptoms of sepsis nor implemented interventions in accordance with the sepsis protocol.

Further review of Patient #2's ED record revealed the patient was medically cleared for admission to the Behavioral Health Unit on 12/20/18 at 3:25 PM, with diagnoses of Psychosis, Hypertension (high blood pressure), Urinary Tract Infection, and Tardive Dyskinesia.

Review of Patient #2's treatment plan revealed the facility identified that the patient had behavioral health concerns; however, there was no documented evidence that the facility identified that the patient had a UTI nor developed interventions to address the infection; e.g., monitoring the patient, notifying the physician of changes, etc.

Review of Patient #2's nursing notes for 01/05/19 at 6:10 PM revealed the patient reported pain/discomfort in his/her chest that that was a "7" on a scale of 0-10. The nurse documented that the provider would be notified. According to the physician orders, an order was obtained for an EKG and troponin levels for the patient.

Review of Patient #2's EKG dated 01/05/19 at 6:38 PM revealed the patient had "T wave abnormality," to consider anterior and inferior ischemia (reduced blood flow), and had a prolonged QT interval. The EKG results revealed the test was abnormal.

Review of Patient #2's Troponin I results dated 01/05/19 at 7:43 PM revealed the patient's result was 0.296 ng/mL (the reference range for 0.04-0.779 ng/mL is "indeterminate range, suspicious of MI (heart attack), clinical correlation required." Further review revealed the patient's C-Reactive Protein on 01/05/19 at 7:56 PM was 5.72 mg/dL, which was listed as abnormal (greater than 2.0 mg/L indicates severe inflammation and can be elevated in acute or chronic inflammatory conditions, tissue injury, ischemia or infarction (decreased or lack of blood supply, such as what occurs with a heart attack), or infection).

Continued review of Nursing Notes revealed on 01/05/19 at 8:36 PM RN #1 notified Physician #6 via telephone regarding Patient #2's EKG results, cardiac marker results, and that the patient's chest pain had improved to a "5" on a scale of 0-10. The nurse documented no new orders were obtained. Continued review of Patient #2's care plan revealed no documented evidence that a care plan was developed/implemented to address the patient's chest pain or abnormal test results and no documented evidence that the chest pain protocol was implemented.

Further review of Patient #2's Troponin I results on 01/06/19 at 1:41 AM revealed the level was 0.231 ng/mL and on 01/06/19 at 8:03 AM the result was 0.251 ng/mL (a range 0.04-0.779 ng/mL indicated "indeterminate range, suspicious of MI, clinical correlation required." However, there was no documented evidence that staff notified Patient #2's physician of the Troponin results on 01/06/19.

Review of a progress note dated 01/06/19 at 2:24 PM revealed Physician #6 documented that Patient #2 had some tingling and dizziness and that his/her gait was unsteady. There was no documented evidence that Physician #6 addressed the patient's chest pain nor the EKG, troponin, and C-Reactive Protein results.

Interview with Physician #6 on 04/25/9 at 11:30 AM revealed she might not have recognized that Patient #2's laboratory results were elevated. Physician #6 stated, "I thought they were in the gray area, not elevated area." She also stated she normally reviewed test results and would contact Cardiology if an EKG or troponin level was abnormal. Physician #6 also stated she was aware the facility had a chest pain protocol and stated Nursing or a physician could implement the protocol; however, she stated the patient would have to be moved to another unit for telemetry (cardiac monitoring). The physician stated Patient #2 was not transferred because Cardiology was not consulted.

2. Review of Patient #6's medical record revealed the patient presented to the ED on 11/19/18 at 11:58 PM with complaints of bilateral lower extremity swelling, chest pain, abdominal pain and distension, nausea, vomiting, and diarrhea. The facility obtained a stool specimen for culture and the patient was discharged home. Further review revealed on 11/21/18, the facility obtained the results of the stool culture for Patient #6, which revealed Campylobacter antigens (when present, indicates a Campylobacteriosis infection is present which is often caused by foodborne illness). However, there was no documentation that the facility attempted to notify the patient of the results until 11/22/18, seven days later. Further review of the record revealed the patient did not answer at the home. There was no evidence the facility attempted to notify the patient of the results again until a certified letter was mailed to the patient on 12/05/18, fourteen days after the facility obtained the results of the culture.

3. Review of Patient #3's medical record revealed the patient presented to the ED on 07/08/18 and the facility obtained a specimen for a urine culture. Patient #3 was discharged home on 07/08/18. Further review revealed on 07/11/18, the facility obtained the urine culture result for Patient #3. The results of the culture revealed the patient had E. coli. However, the facility did not attempt to notify the patient via phone of the results until 07/19/18, which was unsuccessful. Further review revealed no further attempts were made to contact the patient until a letter was sent to the patient on 07/26/18.

Interview with the CEO on 04/25/19 at 6:15 PM revealed after the unexpected outcome involving Patient #2 the facility reviewed the incident and put together a plan of action to correct some issues the facility found during the review. The CEO stated that now all Behavioral Health staff are assigned roles during a code whether the code was for a Rapid Response or a Code Blue. The CEO also stated the facility made some minor changes to the Rapid Response Policy and Code Blue policy regarding who has to respond. Continued interview revealed the facility also put together a handoff communication system between physicians so that they had to report any patient issues/changes in conditions that had occurred while they are covering patients. The CEO also stated the Behavioral Health Unit re-educated all nursing staff on the chest pain protocol. Further interview with the CEO revealed that he was involved with all issues that he was made aware of and assisted each department with needed changes to ensure the safety of the patients at the facility. However, further interview with the CEO and review of documentation provided by the facility revealed no documented evidence that all staff were retrained regarding the facility's code policies including physicians of the facility; that physicians were educated regarding the facility's chest pain protocol or when to obtain a consultation; that staff were educated on accurately completing a sepsis screening in accordance with the facility's policy and taking necessary action based on the policy; or that nursing staff were educated regarding notifying providers of abnormal lab results or developing a care plan to address all patient concerns. Further interview with the CEO revealed the facility had also developed an action plan in approximately December 2018 because the facility identified that staff were not timely notifying patients of abnormal laboratory results after they were discharged from the ED. However, the CEO provided no evidence that the facility had identified the concern or that action had been taken.

PATIENT RIGHTS

Tag No.: A0115

Based on interviews, record review, and review of the facility's policies, it was determined the facility failed to protect and promote the rights of one (1) of ten (10) sampled patients (Patient #2). Review of Patient #2's medical record revealed the patient presented to the ED on 12/30/18 with a change in mental status. The facility conducted a sepsis screening during triage, prior to laboratory testing, and determined the screening was negative. However, review of Patient #2's laboratory testing revealed his/her white blood cell count and glucose were elevated and the patient had white blood cells in his/her urine (indicative of an infection). The facility failed to identify that according to their sepsis protocol the patient had signs and symptoms of sepsis; subsequently, the facility failed to take necessary actions based on the screening. The facility admitted Patient #2 to the Behavioral Health Unit on 12/30/18 with diagnoses of Psychosis, Hypertension (high blood pressure), Urinary Tract Infection, and Tardive Dyskinesia. However, the facility failed to develop a plan to address/treat the patient's infection. Although the facility completed subsequent sepsis screenings after admission, the facility failed to identify that the patient had an infection, which resulted in the screenings being negative and no further action was taken.

Further, record review revealed on 01/05/19 at approximately 6:10 PM, Patient #2 had chest pain. Registered Nurse (RN) #1 notified Physician #6 (a Psychiatrist) and obtained orders for an electrocardiogram (an EKG records the electrical activity of the heart) and Troponin level (proteins released when the heart muscle has been damaged). However, review of nursing notes revealed when the patient's EKG results came back "abnormal" and Patient #2's Troponin level was elevated, Physician #6 told RN #1 to continue to monitor Patient #2. There was no evidence the facility initiated the chest pain protocol or developed a care plan to address the patient's chest pain. In addition, the patient had two other elevated Troponin levels on 01/06/19; however, there was no documented evidence that the patient's physician was notified.

Further review of Patient #2's medical record revealed on 01/08/19, Patient #2 collapsed in the shower and staff called a Rapid Response announcement at approximately 10:44 AM (a Rapid Response was to support hospital personnel outside the Emergency Department and Adult Critical Care Units with early intervention in adult inpatients or observation patients who demonstrated acute changes and/or were progressively deteriorating). Interviews revealed staff from other units had not responded and another Rapid Response was called at approximately 10:47 AM, followed by a Code Blue (a Code Blue is announced overhead when someone is not breathing and/or has no heartbeat) at 10:47 AM. Interviews revealed staff began CPR for Patient #2. However, the Emergency Department physician did not respond immediately to the Code Blue announcement, but had someone call to make sure he was needed before he responded. The Code Team began administering emergency medications at approximately 10:51 AM once the physician arrived. However, Patient #2 expired on 01/08/19 at 11:25 AM.

PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT

Tag No.: A0145

Based on interviews, record review, and review of the facility's policies, it was determined the facility failed to protect one (1) of ten (10) sampled patients (Patient #2) from neglect. Patient #2 presented to the ED on 12/30/18 with a change in mental status. A sepsis screening was conducted during triage prior to laboratory testing and was documented as negative. When Patient #2 had laboratory testing, his/her white blood cell count and blood glucose were elevated and the patient had white blood cells in his/her urine (indicative of an infection); however, the facility failed to identify that according to their sepsis protocol that the patient had signs and symptoms of sepsis. Subsequently, the facility failed to take necessary actions based on the screening. The facility admitted Patient #2 to the Behavioral Health Unit on 12/30/18 with diagnoses of Psychosis, Hypertension (high blood pressure), Urinary Tract Infection, and Tardive Dyskinesia. However, the facility failed to develop a plan to address/treat the patient's infection. Although the facility completed subsequent sepsis screenings after admission, the facility failed to identify that the patient had an infection, which resulted in the screenings being negative and no further action was taken.

Further, on 01/05/19 at approximately 6:10 PM, Patient #2 had chest pain. Registered Nurse (RN) #1 notified Physician #6 (a Psychiatrist) and obtained orders for an electrocardiogram (an EKG records the electrical activity of the heart) and Troponin level (proteins released when the heart muscle has been damaged). However, when the patient's EKG results came back "abnormal" and Patient #2's Troponin level was elevated, Physician #6 told RN #1 to continue to monitor Patient #2. In addition, the patient had two other elevated Troponin levels on 01/06/19; however, there was no documented evidenced the patient's physician was notified. In addition, there was no evidence the facility implemented their Chest Pain Protocol or developed a care plan to address the patient's chest pain. On 01/08/19, Patient #2 collapsed in the shower and staff called a Rapid Response announcement at approximately 10:44 AM (a Rapid Response was to support hospital personnel outside the Emergency Department and Adult Critical Care Units with early intervention in adult inpatients or observation patients who demonstrated acute changes and/or were progressively deteriorating). However, staff from other units had not responded and another Rapid Response was called at approximately 10:47 AM, followed by a Code Blue (a Code Blue is announced overhead when someone is not breathing and/or has no heartbeat) at 10:47 AM. Interviews revealed staff began CPR for Patient #2. However, the Emergency Department physician did not respond immediately to the Code Blue announcement, but had someone call to make sure he was needed before he responded. The Code Team began administering emergency medications at approximately 10:51 AM once the physician arrived. Patient #2 expired on 01/08/19 at 11:25 AM.

The findings include:

Review of the facility policy titled, "Suspected Child/Adult Neglect/Abuse" revised 11/29/18 revealed the facility defined Adult Neglect as the deprivation of services by a care taker which are necessary to maintain the health and welfare of an adult.

Review of the facility policy titled "Rapid Response Team" revised 10/03/18 revealed the purpose of the Rapid Response Team was to support hospital personnel outside the Emergency Department and Adult Critical Care Units with early intervention in adult inpatients or observation patients who demonstrate acute changes and/or were progressively deteriorating. The rapid Response Team was not intended to bypass regular communication with the patient's physician or to remove the role of the primary care provider. Continued review of the policy revealed the patient's primary nurse would remain with the patient to assist with care, notify the primary physician, and provide information. The policy further stated the House Patient Care Manager, Respiratory Therapist, and an RN from the Critical Care Unit were required to respond and floor/department personnel would be available as needed to support initiatives as requested by the team.

Review of the facility policy titled "Code Blue" revised 07/11/16 revealed the purpose was to provide a unified emergency response team in order to optimize outcomes for persons having a cardiac and/or pulmonary arrest, excluding DNR patients. "Code Blue" would identify a cardiac and/or pulmonary arrest. The policy stated the Code Blue Primary Team would respond to the location STAT. All units that were designated for the team would assign a person to be on the Code Team. The policy stated if that person was unable to respond STAT, it was his/her responsibility to get another person to respond in their place. According to the policy, the Primary Team consisted of the ED Physician or Attending Physician, Critical Care RN, Telemetry Unit RN, Primary Nurse, Respiratory Therapist, and CNA/Designee from the code unit.

Review of the facility's policy titled "Adult Sepsis Bundle/Screening" dated 11/17/17 revealed the purpose of the policy was to provide guidelines for screening and management of sepsis, severe sepsis, and septic shock for adult patients. The policy stated the sepsis bundle followed evidence-based early recognition and guidelines for treatment for patients presenting to the ED and those with, or developing infections within the inpatient units. The policy stated sepsis is defined as at least two of the following signs and symptoms and a new or suspected infection: hyperthermia (temperature greater than 100.9) or hypothermia (temperature less than 96.8); tachycardia (heart rate greater than 90); white blood cell count greater than twelve or less than four; respiratory rate greater than 20; acute mental status changes; and hyperglycemia in the absence of Diabetes (greater than 140). The policy stated in the ED, the triage nurse would asses all patients via the ED Sepsis Screening tool by the criteria listed above. According to the policy, on the inpatient units, a nurse would assess and screen all inpatients for sepsis and severe sepsis every 12 hours utilizing the nursing electronic sepsis screening tool. If the patient screens positive, the physician is notified and the Nursing Sepsis Protocol is initiated and within three hours upon initial recognition lactic acid would be measure, blood cultures drawn prior to antibiotic administration, early and appropriate broad spectrum antibiotic administration, and IV fluids for hypotension or lactic acid greater than or equal to four.

Review of the facility's "Low Risk Chest Pain" protocol, undated, revealed the protocol required nursing staff to monitor the patients vital signs every 15 minutes until stable, then every four (4) hours; provide continuous cardiac monitoring; obtain a 12 Lead EKG "now" then every six (6) hours times two (2) and as needed for unrelieved or new chest pain; assess the patient's intake and output (every shift); weigh the patient (once for every occurrence), obtain Cardiac Labs (Serial Troponin) every six (6) hours times two (2), and as needed for unrelieved or new chest pain; and to insert and maintain an IV Saline lock.

Review of Patient #2's medical record revealed the patient presented to the facility's Emergency Department on 12/30/18 at 1:09 PM with complaints of increased depression, "found at church with no shoes, no socks and no coat today." Review of the triage assessment revealed on 12/30/18 at 1:09 PM Patient #2's vital signs were as follows: pulse was 109 (normal resting heart rate is 60-100), oxygen saturation was 96% on room air (normal is 95-100%), blood pressure was 144/87 (normal is less than 120/80), and respirations were 16 (normal resting respirations are 12-20). Review of the triage sepsis screen revealed the patient had an "acutely altered mental status" and heart rate above 90; however without laboratory studies being conducted (blood glucose, White Blood Count [WBC]), the triage nurse indicated Patient #2's sepsis screen was negative. However, review of Patient #2's laboratory results resulted on 12/30/18 at 1:51 PM revealed the patient's WBC was elevated at 15.06 (normal range was 4.5-12.50 and greater than 12 is a possible sign of sepsis according to the facility's policy), Neutrophil % was 80.5 (normal range 30.0-70.0, an elevated level is an indicator of infection), Glucose was 141 (normal range was 70-110 and greater than 140 was a sign of sepsis according to the facility's policy), and the patient's urinalysis revealed the patient had two plus leukocytes (the presence indicates an infection). However, there was no documented evidence staff completed another sepsis screening in the ED and/or identified the patient's signs and symptoms of sepsis and implemented interventions to treat/identify the infection.

Further review of Patient #2's ED record revealed the patient was medically cleared for admission to the Behavioral Health Unit on 12/20/18 at 3:25 PM, with diagnoses of Psychosis, Hypertension (high blood pressure), Urinary Tract Infection, and Tardive Dyskinesia.

Review of Patient #2's treatment plan revealed the facility identified the patient had behavioral health concerns; however, there was no documented evidence the facility identified the patient had a UTI nor developed interventions to address the infection; e.g. monitoring the patient, notifying the physician of changes, etc.

Review of Adult Sepsis Screening Tools revealed staff completed another sepsis screen for Patient #2 on 12/30/18 at 8:00 PM and indicated the patient had a WBC count greater 12000 or less than 4000 and that the patient had a blood glucose of greater than 140 without a Diabetes diagnosis. Although staff indicated the patient had two or more criteria present, staff documented the patient had no known or suspected infections and the screening was negative and no further action was taken. In addition, on 01/01/19 at 9:19 AM, staff indicated the patient had two or more criteria present (WBC and heart rate greater than 90); however, documented that the patient had no known or suspected infections and the screening was negative, which required no further action/testing to treat sepsis.

Further review of Adult Sepsis Screening Tools dated 12/31/18 at 7:21 AM and 7:40 PM, 01/01/19 at 7:40 PM, 01/02/19 at 7:30 PM, 01/03/19 at 9:09 AM and 7:35 PM, 01/04/19 at 7:36 AM and 9:00 PM, 01/05/19 at 6:10 AM and 8:00 PM, 01/06/19 at 8:00 PM, 01/07/19 at 7:24 AM and 8:00 PM, 01/08/19 at 7:51 AM, revealed staff completed the screening tools but documented the patient had no known or suspected infection on each screening. Further review revealed on 01/05/19 at 6:10 AM and 8:00 PM, 01/06/19 at 8:00 PM, 01/07/19 at 8:00 PM, staff documented that the patient had two or more indicators of sepsis present, but documented the patient had no known or suspected infection on each screening. Subsequently, the screenings were negative and no further action was taken as required by the facility's sepsis protocol.

Review of History and Physical (H&P) for Patient #2 dated 12/31/18 at 7:47 AM revealed the physician documented the patient had "depression, altered mental status and confusion bizarre behavior." Physician #2 documented that the patient's medications included: Buspar 10 mg three times a day (treats anxiety); Neurontin 300 mg three times a day (treats pain); Apresoline 100 mg take two times a day(treats high blood pressure); Norco 5/325 every 12 hours (treats pain); Lisinopril 40 mg daily (treats high blood pressure); Lopressor 50 mg two times a day (treats high blood pressure); and Seroquel 25 mg every night (antipsychotic medication). Continued review of the H&P revealed Physician #2 documented that Patient #2 had "Sinus tachycardia with the systolic murmur heard over the entire precordial area." Physician #2 documented the plan was to " ...hold back psychotropic medications at least temporarily" and to treat the patient's hypertension, UTI, and Tardive Dyskinesia.

Review of Patient #2's EKG report dated 12/30/18 at 4:48 PM revealed the patient's EKG was abnormal with Sinus Tachycardia (increased heart rate), Biatrial Enlargement (top chambers of the heart were enlarged), and an Anterior Infarct (heart attack) (age could not be determined).

Review of Physician orders revealed Physician #2 ordered a Cardiology consult for Patient #2 on 12/31/18 at 8:44 AM due to "EKG findings and significant systolic murmur over the entire pericardial area." Continued review of the Physician orders revealed another Cardiology consult was ordered by Physician #2 on 01/02/19 at 9:02 AM due to "follow up original consult, need medical clearance for ECT".

Review of a Cardiology Consult note completed by Physician #5 dated 12/31/18 at 11:33 AM revealed the physician was consulted to evaluate Patient #2's systolic ejection murmur (heart murmur), as well as an EKG that demonstrated biatrial enlargement and an old anterior myocardial infarct (heart attack). Physician #5 concluded that Patient #2 had a Systolic Ejection Murmur and EKG abnormalities and ordered a repeat EKG and echocardiogram.

Review of a Cardiology Progress Note Follow-Up dated 01/02/19 at 6:15 PM revealed Physician #5 documented that Patient #2 had a "systolic ejection murmur, despite recent normal echocardiogram, echocardiogram was repeated in view of the obvious murmur." The note stated that the patient's repeat EKG on 12/31/18 was "essentially completely normal confirming the etiology of the abnormalities on the first EKG to be misplacement of the chest leads on the chest wall." The cardiologist's impression was that the patient had no identified cardiac abnormalities.

Review of a Progress Notes dated 01/02/19 at 8:38 AM, 01/03/19 at 9:24 AM, 01/04/19 at 7:58 AM, and on 01/05/19 at 3:21 PM revealed Physician #2 documented Patient #2 was not consistently taking medications as ordered. In addition, on 01/03-05/19, he documented that the patient was refusing to eat and on 01/04-05/19 the patient refused to participate in the evaluation process. Further review revealed on 01/05/19, Physician #2 documented that the patient was lying in bed with his/her eyes mostly closed and would respond, "No." According to the Progress Notes, the physician continued medications to treat the patient and continued supportive nursing care.

Review of Patient #2's nursing notes for 01/05/19 at 6:10 PM revealed the patient had pain/discomfort in his/her chest that he/she rated at a "7" out of "10" rating. The nurse documented that the provider would be notified and to refer to new orders and the patient's Medication Administration Record. According to the physician orders, an order was obtained for an EKG and Troponin levels for the patient.

Review of Patient #2's EKG dated 01/05/19 at 6:38 PM revealed the patient had "T wave abnormality", to consider anterior and inferior ischemia (reduced blood flow), and had a prolonged QT interval. The EKG results revealed the test was abnormal.

Review of Patient #2's Troponin I test results dated 01/05/18 at 7:43 PM revealed the patient's result was 0.296 ng/mL (the reference range for 0.04-0.779 ng/mL is "indeterminate range, suspicious of MI (heart attack), clinical correlation required". Further review revealed the patient's C-Reactive Protein on 01/05/19 at 7:56 PM was 5.72 mg/L, which was listed as abnormal (greater than 2.0 mg/L indicates severe inflammation and can be elevated in acute or chronic inflammatory conditions, tissue injury, ischemia or infarction [decreased or lack of blood supply, such as what occurs with a heart attack], or infection).

Continued review of Nursing Notes revealed on 01/05/19 at 8:36 PM RN #1 notified Physician #6 via telephone regarding Patient #2's EKG results, cardiac marker results, and that the patient's chest pain had improved to a five on a scale of 0-10. The nurse documented no new orders were obtained. Continued review of Patient #2's care plan revealed no documented evidence that a care plan was developed/implemented to address the patient's chest pain or abnormal test results.

Interview with RN #1 on 04/18/19 at 11:50 AM revealed at approximately 6:00 PM on 01/05/19, Patient #2 complained of chest pain and the RN contacted Physician #6 (a psychiatrist). RN #1 stated Physician #6 ordered an EKG and cardiac markers and she notified the physician when the test results came back abnormal. She stated it was up to the physician to decide what treatment was needed. There was no documented evidence the chest pain protocol was initiated for Patient #2; subsequently, the patient's heart was not monitored continuously, vital signs were not obtained every fifteen minutes, and an IV was not started and maintained according to the facility's protocol.

Interview with RN #6 on 04/18/19 at 4:15 PM revealed she provided care to Patient #2 and recalled the patient refused medications and food/fluids, but to her knowledge she believed the patient was medically stable. According to the RN, after the patient complained of chest pain, that should have changed "everything." RN #6 stated when a patient's condition changed nursing staff had to contact the provider on call, who was a psychiatrist, and the psychiatrist determined when to involve a medical doctor in the patient's care.

Further review of Patient #2's Troponin I test results on 01/06/19 at 1:41 AM revealed the level was 0.231 ng/mL and on 01/06/19 at 8:03 AM the result was 0.251 ng/mL (a range 0.04-0.779 ng/mL indicated "indeterminate range, suspicious of MI, clinical correlation required". However, there was no documented evidence staff notified Patient #2's physician of the Troponin results on 01/06/19.

Review of a progress note dated 01/06/19 at 2:24 PM revealed Physician #6 documented that Patient #2 was dressed and sitting up in bed, had been eating better, and taking medications. The physician documented that initially patient was unresponsive, but was able to state he/she was "not [so] good." Continued review of the progress note revealed Patient #2 stated he/she had some tingling and dizziness. The physician documented that Patient #2's gait was unsteady and a sitter was ordered for the patient. Physician #6's plan was to continue supportive nursing care, to continue Ativan for catatonic symptoms, to continue Apresoline, Lisinopril, and Metoprolol for hypertension, and to continue nitrofurantoin for the patient's UTI. There was no documented evidence that Physician #6 addressed the patient's chest pain nor the EKG, Troponin and C-Reactive Protein results.

Interview with Physician #6 on 04/25/19 at 11:30 AM revealed she recalled being notified that Patient #2 had chest pain and recalled ordering an EKG and laboratory tests. Physician #6 initially stated she did not recall a nurse reporting the test results, but then stated a nurse notified her of the results. The physician stated when nursing called about test results, they routinely just gave her numbers and she may not have recognized the Troponin level was elevated. Physician #6 stated, " I thought they were in the gray area, not elevated area." She also stated she normally reviewed test results and would contact cardiology if an EKG or Troponin level was abnormal. However, Physician #6 stated she did not recall the patient's Troponin levels being elevated or "flagging" and thought they were in "a gray area". Physician #6 stated she would have consulted a cardiologist based on the test results if she had been aware they were high or that the EKG was different than the baseline EKG. Physician #6 stated she was aware the facility had a chest pain protocol and stated nursing or a physician could implement the protocol; however, she stated the patient would have to be moved to another unit for telemetry (cardiac monitoring). The physician stated Patient #2 was not transferred because cardiology was not consulted.

Review of a progress note dated 01/07/19 at 8:25 AM revealed Physician #2 documented Patient #2 "don't feel good." The note stated that Patient #2 remained in bed and did not want to get up, but was alert with a "markedly restricted and depressed" affect that was slightly improved since 01/04/19. Physician #2's plan was to decrease the patient's Ativan dosage that "is apparently causing difficulty with [his/her] gait". According to Physician #2's note, the patient had no reoccurrence of chest pain.

Review of a nursing note revealed on 01/07/19 at 8:26 AM, Patient #2 reported pain/discomfort that was bilateral/generalized all over and described as frequent and aching. The note stated Motrin was administered.

Review of a Progress Note dated 01/08/19 at 7:27 AM revealed Physician #2 documented Patient #2 "don't feel good." Physician #2 further documented that the patient had " ...some improvement since yesterday-affect remains restricted, latency of response less. Patient [himself/herself] states I've had trouble getting my words out. Gait improved [it is] still somewhat unsteady. Voices "tell me I've got to get better". According to the Progress Note, Patient #2 was having back pain that he/she rated five on a zero to ten scale and the physician reminded the patient that he/she had hydrocodone available if needed.

Interview with Physician #2 on 04/25/19 at 10:55 AM revealed he was Patient #2's primary care provider while he/she was hospitalized. Physician #2 stated Patient #2 was very "ill" not eating or sleeping and was depressed during the course of the patient's hospitalization. Physician #2 stated Physician #6 did not inform him of Patient #2's chest pain, abnormal EKG's, or cardiac markers when he returned to work on 01/07/19 (even though the physician documented on 01/07/19 that the patient had not experience any further chest pain). Physician #2 stated if the nursing staff had reported to him on 01/07/19 of the chest pain incident, he would have ordered a cardiac consult.

Continued review of Patient #2's Nursing Notes dated 01/08/19 at 12:18 PM revealed nursing staff was called to the shower room. The note stated Patient #2 was in the shower and was lethargic, not responsive to verbal commands, and had shallow respirations. The note stated a Code Rapid Response was called at 10:44 AM. Further review revealed Patient #2's blood pressure was 61/32, pulse was 114, and Blood Glucose was 153. The note revealed another Code Rapid Response was called at 10:47 AM. Further review revealed staff moved Patient #2 to a bed and the patient became completely unresponsive with no pulse; subsequently a Code Blue was called at 10:47 AM. According to the Nursing Note, Cardiopulmonary Resuscitation (CPR) was immediately started and an Intravenous (IV) line was started on the third attempt. Continued review of the Nursing Note revealed the code team arrived "at 10:51 AM at which time the team took command over Code Blue".

Review of the Code Sheet for Patient #2 revealed staff began administering emergency medications to resuscitate the patient at 10:52 AM on 01/08/19 (Epinephrine 1 mg) and was intubated at 10:56 AM. At 11:02 AM, the patient's vital signs were 61/32 with a heart rate of 44 and an intraosseous line (an IO is the process of injecting medications and fluids directly into the marrow of a bone when an IV is not available or not feasible) was started. Further review revealed at 11:18 AM the patient's next of kin was contacted to alert them of the patient's pending transfer to the critical care unit. At 11:22 AM, the patient's blood pressure was 187/34 and heart rate was 28. However, at 11:23 AM, Patient #2 had no left or right carotid pulse and no left or right radial pulse. The documentation revealed the code ended at 11:25 AM and the physician pronounced the patient dead.

Review of a Progress Note dated 01/08/19 at 4:45 PM revealed Physician #3 documented he was called to the psychiatry unit for a "Code Blue" for Patient #2. Patient #2's nurse reported the patient had been experiencing generalized weakness and his/her blood pressure had been running low. Patient #2 was in the shower "when [his/her] eyes just rolled back and [he/she] went unresponsive." Continued review revealed Physician #3 arrived with CPR already in progress, being bagged with 100 % oxygen via bag valve mask, with an oral airway in place. Patient #2 was pulseless, apneic (not breathing), unresponsive, cyanotic (blue), with dilated, unreactive pupils and Pulseless Electrical Activity. The Progress Note stated Advanced Life Support (ALS) protocol was followed. Continued review revealed Physician #3 documented that Patient #2 experienced pulseless electrical activity, a brief episode of ventricular fibrillation, periods of asystole, followed by more periods of pulseless electrical activity. Facility staff were able to briefly regain a pulse on more than one occasion, but a pulse was not sustained. The physician further documented that Patient #2 was intubated and received intravenous epinephrine, atropine, IV fluids, amiodarone, Levophed, and sodium bicarbonate. Nursing established an IV in the right upper extremity, which was initially patent but became nonfunctional. Nursing established another IV in the left upper extremity, and the physician was able to establish an intraosseous line in the right tibia. The physician documented that these were performed without interruption in the resuscitative effort and the resuscitative effort was continued exhaustively. According to the Progress Note, Patient #2's pupils remained dilated and unreactive and never showed any spontaneous respirations or neurological signs of life. Physician #2 documented that Patient #2 was showing an agonal PEA rhythm on the monitor and resuscitative effort was terminated and Patient #2 was pronounced dead.

Interview with Licensed Practical Nurse (LPN) #1 on 04/23/19 at 12:40 PM revealed she provided care for Patient #2 on 01/07/19 and on 01/08/19. LPN #1 stated that the patient did not get out of bed on 01/07/19 and it was reported that the patient had been refusing medications and food. Continued interview with LPN #1 revealed on 01/08/19 she recalled staff assisting Patient #2 to the shower and the next thing she knew, they were yelling for assistance. LPN #1 stated a code was called, but was not sure if it was a Code Rapid Response or a Code Blue. However, the LPN stated no one from outside the unit responded to the code. The LPN stated they called a code again and a staff member went to the doors and started letting people in the unit. In the meantime, LPN #1 stated that the Director of Behavioral Health was doing chest compressions and the lead RN was bagging Patient #2. LPN #1 stated that she was running back and forth getting IV supplies. LPN #1 stated that no one could get an IV started on Patient #2, but by that point, someone had let the Code Team in and the team took over. LPN #1 stated that as far as she was aware the facility did not conduct an investigation and no one had interviewed her regarding the incident with Patient #2 on 01/08/19.

Interview with the Director of Behavioral Health on 04/23/19 at 2:00 PM revealed she was in her office on the morning of 01/08/19 when nursing staff called her and the lead RN to the unit. The Director stated as soon as they arrived to the Unit, they heard an announcement for a Rapid Response. The Director stated at that time, Patient #2 was in the bathroom/shower. She stated she went for the crash cart and they moved Patient #2 from the shower to the nearest patient room. Then, the second call went out for the Rapid Response team. The Director stated once on the bed, Patient #2 had no pulse. She stated they began CPR and called for a Code Blue. She stated LPN #1, who worked on the unit, responded and began running to obtain IV supplies. The Director stated she was doing chest compressions and the lead RN was bagging Patient #2. The Director stated the House Supervisor and a nurse from the Critical Care Unit (CCU) then arrived and helped get the patient on a monitor. The Director further stated, "Someone finally let ED staff in [Physician #3] and [RN#4]" and they took over. Further interview with the Director revealed nursing staff and therapy staff developed plans of care for the patients on the Behavioral Health unit; however, it had not been practice to identify and address a patient's medical needs.

Interview with the House Supervisor on 04/23/19 at 2:39 PM revealed she was working on 01/08/19 when a Rapid Response was called. The House Supervisor stated as she was nearing the Behavioral Health Unit, a second Rapid Response was called. She stated a CCU nurse was behind her and a Security Guard let them in the door to the unit. She stated as they were entering, a Code Blue was called. Continued interview revealed when she got to the patient's room, staff were doing chest compressions and bagging the patient. The House Supervisor stated she then received a phone call from ED staff who asked if they needed to respond and she told them "Yes! Now!" The House Supervisor stated after the phone call, Physician #3, RN #4, and possibly one other nurse from the ED responded.

Interview with Registered Nurse (RN) #4 on 04/23/19 at 1:55 PM revealed she was one of the Emergency Department Nurses that responded to the Code Blue on 01/08/19. RN #4 stated that she and Physician #3 responded to the Behavioral Health Unit as other staff were entering the unit. RN #4 stated when she arrived in the room with Patient #2, nursing staff was attempting to gain IV access, but were having trouble so she took over and was successful in obtaining IV access. RN #4 stated Physician #3 intubated Patient #2 (placed a breathing tube in the patient's throat). However, despite their attempts the patient expired.

Interview with Physician #3 on 04/25/19 at 11:05 AM revealed he was working on 01/08/19 when a Code Blue was called on the Behavioral Health Unit. Physician #3 stated that when the code was called he had someone call and confirm that it was necessary for him to respond because to the best of his recollection, he had two (2) critical patients he was attending to in the ED. He stated he felt he needed to confirm that he was needed before he left the ED patients. Physician #3 stated once it was confirmed that he was needed, he went immediately and to the best of his memory, staff let him in the unit. Further interview with Physician #3 revealed he would not comment as to the cause of Patient #2's death. According to Physician #3, he was unaware of any policy changes/education since the incident.

Continued interview with Physician #6 on 04/25/19 at 11:30 AM revealed she discussed Patient #2's case with a Cardiologist after the patient expired, but stated she did not know the cause of the patient's death.

Interview with the Chief of Psychiatry on 04/25/19 at 12:05 PM revealed all patients admitted to the Behavioral Health Unit were medically cleared in the ED prior to admission to the Behavioral Health Unit. The Chief of Psychiatry stated once on the unit, the Psychiatrist was the primary care provider for all patients with "simple medical concerns" and psychiatric needs. Continued interview revealed whenever the psychiatrist had any questions or concerns regarding medical issues, the hospitalists at the facility were available for consultation. According to the Director, consultations had never been an issue or concern to his knowledge.

Interview with Patient #2's Family Member on 04/16/19 at 10:00 AM revealed that the facility contacted him and requested consent for electrical shock treatment for the patient and he declined that treatment option. Patient #2's Family Member stated the facility also reported to him that Patient #2 was not eating, drinking, or taking medications but did not discuss their course of treatment for those issues. Patient #2's Family Member further stated that he had a court date scheduled for 01/09/19 to obtain guardianship of Patient #2 and he had plans to move the patient to another facility for treatment. However, the patient passed away the day before the court date, 01/08/19. Patient #2's Family Member stated the facility notified him on 01/08/19 that the patient's cause of death was a "heart attack". Then, the facility contacted him sometime in March of 2019 and Physician #2 met with him and informed him that the facilit

QAPI

Tag No.: A0263

Based on interview, record review, and review of facility policies, it was determined that the facility failed to implement and maintain an ongoing, data driven Quality Assessment and Performance Improvement program that focused on indicators related to improved health outcomes. Patient #2 presented to the Emergency Department on 12/30/19 with mental status changes. The facility admitted the patient to the Behavioral Health Unit with diagnoses that included Psychosis and Urinary Tract Infection. Review of the patient's medical record revealed the patient collapsed in the shower on 01/08/19 and expired after resuscitation efforts were not successful. Review of the facility's quality indicators revealed the facility monitored indicators including sepsis and mortality. However, review of Patient #2's medical record revealed the facility failed to ensure staff completed Sepsis Screenings/Protocols in accordance with facility policy; failed to ensure physicians implemented the facility's chest pain protocol and consults were conducted as needed; failed to ensure physicians were notified of laboratory results; and failed to ensure the Behavioral Health Unit developed plans of care for medical issues. In addition, the facility failed to ensure staff timely reported the results of positive cultures to Patient #3 and Patient #6 after the patients were discharged from the facility's Emergency Department. Interview with the facility Chief Executive Officer revealed the facility reviewed Patient #2's medical record and believed the facility had taken necessary action to address their failures. However, the facility failed to provide evidence that the failures were identified, action was taken, or that the facility was assessing the effectiveness of any actions taken.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on interview, record review, and review of facility policies, it was determined that the facility failed to identify concerns with care, implement action to address the concerns, and evaluate actions to ensure care was improving. Patient #2 expired in the facility's Behavioral Health Unit on 01/08/19. Review of the facility's quality indicators revealed the facility monitored indicators including sepsis and mortality. However, review of Patient #2's medical record revealed the facility failed to ensure staff completed Sepsis Screenings/Protocols in accordance with facility policy; failed to ensure physicians implemented the facility's chest pain protocol and consults were conducted as needed; failed to ensure physicians were notified of laboratory results; failed to ensure the Behavioral Health Unit developed plans of care for medical issues. In addition, the facility failed to ensure staff timely reported the results of positive cultures to Patient #3 and Patient #6 after the patients were discharged from the facility's Emergency Department.

The findings include:

Review of the facility's Performance Improvement (PI) Plan approved 07/26/18 revealed the goal of the organizational wide PI plan was to guide the facility's efforts in providing healthcare, which produced positive outcomes, met all quality standards, and was cost effective. The policy stated the plan was designed to establish, organize, implement, monitor, and document evidence of an ongoing and systematic quality improvement process. According to the policy, the facility had a "Quality Steering Committee" that included senior leadership, executive directors, and an ADHOC Administrative Board Member. The functions of the committee included establishing expectations, plans, and managing the PI process; ensuring implementation of the processes to measure, assess, and improve the performance of processes; assuring that important processes and activities are measured, assessed, and improved systematically throughout the facility; evaluating actions to confirm they resulted in improvements; taking action when planned improvements are not achieved or sustained; etc. Continued review of the policy revealed the framework for quality improvement included the following components: defining the problem, mapping out the current process, identifying the cause of the problem, implementing and verifying the improvement, maintaining the solution, and starting the cycle again, to more closely meet or exceed the customers' expectations.

Review of the facility's Clinical Quality Indicators revealed the facility reviewed indicators that included, mortality, cardiac, and acute Myocardial Infarctions (MI or heart attack).

Review of Patient #2's medical record revealed the patient presented to the ED on 12/30/18 with a change in mental status. Review of the patient's triage sepsis screening revealed the patient's laboratory values were unknown and staff determined the screening was negative. However, review of Patient #2's laboratory testing dated 12/30/18, completed in the ED revealed the patient's white blood cell count and glucose were elevated and the patient had white blood cells in his/her urine (indicative of an infection). There was no documented evidence that the facility identified that the patient had signs/symptoms of sepsis, according to their sepsis protocol; subsequently, there was no documented evidence that the facility took necessary actions based on the screening.

The facility admitted Patient #2 to the Behavioral Health Unit on 12/30/18 with diagnoses of Psychosis, Hypertension (high blood pressure), Urinary Tract Infection, and Tardive Dyskinesia. However, further review of the patient's medical record revealed no documented evidence the facility developed a plan of care to address/treat the patient's infection. Although the facility completed subsequent sepsis screenings after admission, the facility failed to identify that the patient had an infection, which resulted in the screenings being negative and no further action was taken.

Further, record review revealed on 01/05/19 at approximately 6:10 PM, Patient #2 had chest pain. Registered Nurse (RN) #1 notified Physician #6 (a Psychiatrist) and obtained orders for an electrocardiogram (an EKG records the electrical activity of the heart) and Troponin level (proteins released when the heart muscle has been damaged). However, review of nursing notes revealed when the patient's EKG results came back "abnormal" and Patient #2's Troponin level was elevated, Physician #6 told RN #1 to continue to monitor Patient #2. There was no evidence the facility initiated their chest pain protocol or developed a care plan to address the patient's chest pain. In addition, the patient had two other elevated Troponin levels on 01/06/19; however, there was no documented evidenced the patient's physician was notified.

Further review of Patient #2's medical record revealed on 01/08/19, Patient #2 collapsed in the shower and staff called a Rapid Response announcement at approximately 10:44 AM (A Rapid Response was to support hospital personnel outside the Emergency Department and Adult Critical Care Units with early intervention in adult inpatients or observation patients who demonstrated acute changes and/or were progressively deteriorating) and at approximately 10:47 AM. Then, staff called a Code Blue (A Code Blue is announced overhead when someone is not breathing and/or has no heart beat) at 10:47 AM. Interviews revealed staff began CPR for Patient #2. However, the Emergency Department physician did not respond immediately to the Code Blue announcement. Interviews revealed the ED physician had someone call the Behavioral Health Unit to make sure he was needed before he responded. Further review of Patient #2's medical record revealed the Code Team began administering emergency medications at approximately 10:51 AM once the physician arrived. However, Patient #2 expired on 01/08/19 at 11:25 AM.

2. Review of Patient #6's medical record revealed the patient presented to the ED on 11/19/18 at 11:58 PM with complaints of bilateral lower extremity swelling, chest pain, abdominal pain and distension, nausea, vomiting and diarrhea. The facility obtained a stool specimen for culture and the patient was discharged home. Further review revealed on 11/21/18, the facility obtained the results of the stool culture for Patient #6, which revealed Campylobacter antigens (when present indicates a Campylobacteriosis infection is present which is often caused by foodborne illness). However, there was no documentation that the facility attempted to notify the patient of the test results until 11/22/18, seven days later, and it was noted that the patient did not answer the phone. There was no evidence the facility attempted to notify the patient of the results again until a certified letter was mailed to the patient on 12/05/18, fourteen days after the facility obtained the results of the culture.

Review of Patient #3's medical record revealed the patient presented to the ED on 07/08/18 and the facility obtained a specimen for a urine culture. Patient #3 was discharged home on 07/08/18. Further review revealed on 07/11/18, the facility obtained the patient's urine culture result for Patient #3. The results of the culture revealed the patient had E-Coli. However, the facility did not attempt to notify the patient via phone of the results until 7/19/18, which was unsuccessful. Further review revealed no further attempts were made to contact the patient until a letter was sent to the patient on 07/26/18.

Interview with the Infection Control Director on 04/17/19 at 2:20 PM and on 04/23/19 at 4:40 PM revealed she did not track or monitor infections in the ED. She stated the only responsibility that she had for the ED labs was to report communicable diseases to the Health Department.

Interview with the ED Medical Director on 04/23/19 at 8:16 AM revealed she expected patients to be notified of positive blood cultures within one to two days. She stated she monitored to ensure patients were notified of positive cultures; however, there was no evidence the ED Medical Director monitored how long it took staff to notify patients.

Interview with the CEO on 04/25/19 at 6:15 PM revealed after the unexpected outcome involving Patient #2, the facility reviewed the incident and put together a plan of action to correct some issues the facility found during the review. The actions included: assigning Behavioral Health staff roles during a code; making minor changes to the Rapid Response Policy and Code Blue policy regarding who has to respond; putting together a handoff communication system between physicians so that they had to report any patient issues/changes in conditions that had occurred while they were covering patients; and re-educating all nursing staff on the chest pain protocol. Further interview with the CEO revealed that he was involved with all issues that he was made aware of and assisted each department with needed changes to ensure the safety of the patients at the facility. Further interview with the CEO revealed the facility had also developed an action plan in approximately December 2018 because the facility identified that staff were not timely notifying patients of abnormal laboratory results after they were discharged from the ED. However, the facility failed to provide evidence that all staff were retrained regarding the facility's code policies including physicians of the facility. Further, the facility failed to provide evidence that physicians were educated regarding the facility's chest pain protocol or when to obtain a consultation; that staff were educated on accurately completing a sepsis screening in accordance with the facility's policy and taking necessary action based on the policy; and that staff were educated regarding timely notification of patients of abnormal laboratory results after they were discharged from the ED. In addition, there was no evidence the concerns were being monitored in the facility's QAPI Program.

NURSING SERVICES

Tag No.: A0385

Based on interview, record review and review of facility policy it was determined the facility failed to ensure services were supervised by a Registered Nurse (RN) for one (1) of ten (10) sampled patients (Patient #2). Review of Patient #2's medical record revealed the presented to the Emergency Department (ED) on 12/30/18 with a change in mental status. Review of the patient's ED record revealed the patient's white blood cell count was elevated and the patient had white blood cells in his/her urine (both indicative of an infection). The facility admitted Patient #2 to the Behavioral Health Unit on 12/30/19 with diagnoses that included a Urinary Tract Infection; however, review of the patient's care plan revealed the facility failed to develop a plan to address/treat the patient's infection.

In addition, further review of Patient #2's medical record revealed on 01/05/19 at approximately 6:10 PM, Patient #2 had chest pain and RN #1 contacted Physician #6 (a Psychiatrist) and obtained orders for an electrocardiogram (an EKG records the electrical activity of the heart) and troponin level (proteins released when the heart muscle has been damaged). Record review revealed Patient #2's EKG results came back "abnormal" and Patient #2's troponin level was elevated. Interview and record review revealed staff notified Physician #6 that Patient #2's EKG and initial Troponin level was abnormal and the physician told staff to continue to monitor the patient. However, there was no documented evidence that staff notified the Physician of On 01/08/19, Patient #2 collapsed in the shower and expired on 01/08/19 at 11:15 AM.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview, record review, and facility policy review, it was determined the facility failed to ensure a registered nurse supervised and evaluated the care for each patient. Patient #2 was admitted to the Behavioral Health Unit of the facility on 12/30/18. On 01/05/19 at approximately 6:10 PM, Patient #2 had chest pain and RN #1 contacted Physician #6 (a Psychiatrist) and obtained orders for an electrocardiogram (an EKG records the electrical activity of the heart) and troponin level (proteins released when the heart muscle has been damaged). Interview and record review revealed staff notified Physician #6 that Patient #2's EKG and initial Troponin level was abnormal and the physician told staff to continue to monitor the patient. However, there was no documented evidence that staff notified the Physician of Troponin results completed on 01/06/19 at 1:41 AM and on 01/06/19 at 8:03 AM that revealed abnormal levels. On 01/08/19, Patient #2 collapsed in the shower and the patient expired on the Behavioral Health unit on 01/08/19 at 11:25 AM.

The findings include:

Review of the facility policy titled, "Patient Assessment/Reassessment: Nursing, Nutrition, Social Services and Behavioral Health" reviewed 07/03/18 revealed the patient's diagnosis, treatment settings, and desire for treatment, along with a response to treatment, determined the scope and intensity of a reassessment. The policy stated reassessments would be of sufficient scope to identify potential or actual changes in the patient's condition and the patient's plan of care would be modified as necessary.

Review of the medical record for Patient #2 revealed the facility admitted the patient to the Behavioral Health Unit on 12/30/18, with diagnoses that included Psychosis, Hypertension, Urinary Tract Infection (UTI), and Tardive Dyskinesia.

Review of History and Physical (H&P) for Patient #2 revealed Physician #2 completed the H&P on 12/31/18 at 7:47 AM and documented the patient had "depression, altered mental status and confusion bizarre behavior." In addition, the physician documented that the patient had "Sinus tachycardia with the systolic murmur heard over the entire precordial area."

Review of Patient #2's EKG report dated 12/30/18 at 4:48 PM revealed the patient's EKG was abnormal with Sinus Tachycardia (increased heart rate), Biatrial Enlargement (top chambers of the heart were enlarged), Anterior Infarct (heart attack), but the age of the heart attack could not be determined.

According to a Cardiology Progress Note Follow-Up dated 01/02/19 at 6:15 PM, Patient #2 repeat EKG on 12/31/18 was "essentially completely normal confirming the etiology of the abnormalities on the first EKG to be misplacement of the chest leads on the chest wall". The cardiologist's impression was that the patient had no identified cardiac abnormalities.

Review of Patient #2's nursing notes for 01/05/19 at 6:10 PM revealed the patient had pain/discomfort in his/her chest that was a "7" out of "10" rating. The nurse documented that the provider would be notified and to refer to new orders.

Review of Patient #2's EKG dated 01/05/19 at 6:38 PM revealed the patient had "T wave abnormality", to consider anterior and inferior ischemia (reduced blood flow), and had a prolonged QT interval. The EKG results revealed the test was abnormal.

Review of the Troponin I results revealed on 01/05/18 at 7:43 PM, Patient #2's Troponin was 0.296 ng/mL (reference range was 0.04-0.779 ng/mL, which was an indeterminate range, suspicious of MI and clinical correlation required). Continued review of Nursing Notes revealed on 01/05/19 at 8:36 PM, RN #1 notified Physician #6 via telephone regarding Patient #2's EKG results, cardiac marker results, and that the patient's chest pain had improved (five on a scale of 0-10). The nurse documented no new orders were obtained.

Interview with Registered Nurse (RN) #1 on 04/18/19 at 11:50 AM revealed at approximately 6:00 PM on 01/05/19, Patient #2 complained of chest pain and the RN contacted Physician #6 (a psychiatrist). RN #1 stated Physician #6 ordered an EKG and cardiac markers and she notified the physician when the initial test results came back abnormal. RN #1 stated her shift ended at 7:00 PM that evening, but stayed later to complete her documentation and notify Physician #6 of Patient #2's first set of abnormal results before she went home.

Continued review of Patient #2's Troponin I results dated 01/06/19 at 1:41 AM revealed the level was 0.231 ng/mL and on 01/06/19 at 8:03 AM, the patient's Troponin was 0.251 ng/mL (reference range was 0.04-0.779 ng/mL, which was an indeterminate range, suspicious of MI, and clinical correlation required). However, there was no documentation that Patient #2's physician was notified of the test results.

An interview was attempted with RN #10 (who was working the night shift on 01/05-06/19 when Patient #2's abnormal Troponin level results returned) on 04/18/19 at 11:45 AM, 04/22/19 at 10:00 AM, and on 04/25/19 at 12:35 PM; however, attempts were unsuccessful and the RN did not return the phone calls.

Review of a progress note dated 01/06/18 at 2:24 PM revealed Physician #6 documented that Patient #2 was dressed and sitting up in bed, had been eating better, and taking medications. The physician documented that initially the patient was unresponsive, but was able to state he/she was "not [so] good." Continued review of the progress note revealed Patient #2 stated he/she had some tingling and dizziness. The physician documented that Patient #2's gait was unsteady and a sitter was ordered for the patient. Physician #6's plan was to continue supportive nursing care, to continue Ativan for catatonic symptoms, to continue Apresoline, Lisinopril, and Metoprolol for hypertension, and to continue nitrofurantoin for the patient's UTI. There was no documented evidence that Physician #6 addressed the patient's chest pain or the EKG and troponin results.

Continued review of Patient #2's Nursing Notes dated 01/08/19 at 12:18 PM revealed nursing staff was called to the shower room. The note stated Patient #2 was in the shower and was lethargic, not responsive to verbal commands, and had shallow respirations.

Review of a Progress Note dated 01/08/19 at 4:45 PM revealed Physician #3 documented he was called to psychiatry unit for a "Code Blue" for Patient #2. Patient #2's nurse reported the patient had been experiencing generalized weakness and his/her blood pressure had been running low. Patient #2 was in the shower "when [his/her] eyes just rolled back and [he/she] went unresponsive." Continued review revealed Physician #3 arrived with CPR already in progress. Patient #2 was pulseless, apneic (not breathing), unresponsive, cyanotic (blue), with dilated, unreactive pupils and Pulseless Electrical Activity. According to the note, despite resuscitation attempts, Patient #2 was pronounced dead.

Interview with Physician #6 on 04/25/9 at 11:30 AM revealed she recalled being notified that Patient #2 had chest pain and recalled ordering tests. Physician #6 initially stated she did not recall a nurse reporting the test results, but then stated a nurse notified her of the initial results. She also stated she normally reviewed test results and would contact cardiology if an EKG or troponin level was abnormal. However, Physician #6 stated she did not recall the patient's Troponin levels being elevated or "flagging" and thought they were in "a gray area".

Interview with Physician #2 on 04/25/19 at 10:55 AM revealed he was Patient #2's primary care provider while he/she was hospitalized. Physician #2 stated Patient #2 was very "ill" not eating or sleeping and was depressed during the course of the patient's hospitalization. Physician #2 stated Physician #6 did not inform him of Patient #2's chest pain, abnormal EKG's, or cardiac markers when he returned to work on 01/07/19 (even though the physician documented on 01/07/19 that the patient had not experienced any further chest pain). Physician #2 stated if the nursing staff had reported to him on 01/07/19 of the chest pain incident, he would have ordered a cardiac consult.

NURSING CARE PLAN

Tag No.: A0396

Based on interview, record review and review of facility policy, it was determined the facility failed to develop and keep current a care plan for one (1) of ten (10) sampled patients (Patient #2). Patient #2 presented to the ED on 12/30/18 with a change in mental status. The facility conducted laboratory testing that revealed the patient's white blood cell count was elevated and the patient had white blood cells in his/her urine (both indicative of an infection). The facility admitted Patient #2 to the Behavioral Health Unit on 12/30/18 with diagnoses that included a Urinary Tract Infection; however, the facility failed to develop a plan to address/treat the patient's infection.

In addition, on 01/05/19 at approximately 6:10 PM, Patient #2 had chest pain and RN #1 contacted Physician #6 (a Psychiatrist) and obtained orders for an electrocardiogram (an EKG records the electrical activity of the heart) and troponin level (proteins released when the heart muscle has been damaged). Patient #2's EKG results came back "abnormal" and Patient #2's troponin level was elevated. However, there was no evidence the facility developed a care plan to address the patient's chest pain or medical needs related to the chest pain and abnormal test results. On 01/08/19, Patient #2 collapsed in the shower and expired on 01/08/19 at 11:15 AM.

The findings include:

Review of the facility's policy titled "Interdisciplinary Care Plan/Education," effective 12/04/17 revealed each patient would have a Care Plan that was appropriate to his/her specific assessed needs. The Care Plan was required to be initiated on admission and should be individualized and revised based on ongoing assessment findings, the patient's response to treatment/interventions, and evaluation of progress toward outcomes. Continued review of the policy revealed care planning started with learning the patient's history, medical diagnosis, and assessment findings. Individualized goals would be added to the Care Plan based on identified patient need(s). The policy stated nursing would document goal progression at a minimum of every shift, including any change in patient condition.

Review of the facility's policy titled, "Patient Assessment/Reassessment: Nursing, Nutrition, Social Services and Behavioral Health" reviewed 07/03/18 revealed the patient's diagnosis, treatment settings and desire for treatment, along with a response to treatment, determined the scope and intensity of the reassessment. Reassessments would be of sufficient scope to identify potential or actual changes in the patient's condition and the patient's plan of care would be modified as necessary.

Review of Patient #2's medical record revealed the patient presented to the facility's Emergency Department on 12/30/18 at 1:09 PM. Review of Patient #2's laboratory results dated 12/30/18 at 1:51 PM revealed the patient's WBC was elevated at 15.06 (normal range was 4.5-12.50) and the patient's urinalysis revealed the patient had two plus leukocytes (both tests indicate the presence an infection). Further review revealed the facility admitted Patient #2 to the Behavioral Health Unit on 12/30/18, with diagnoses that included Psychosis, Hypertension, Urinary Tract Infection, and Tardive Dyskinesia.

Review of the care plan for Patient #2 dated 12/31/18 revealed the facility identified the patient had Coping/Psychosocial, Interdisciplinary Rounds/Family Conference, Individualization and Mutuality, Discharge Needs Assessment, Safety Considerations for self and others, Optimized Coping Skills in Response to Life Stressors, and Develops/Participates in Therapeutic Alliance to Support Successful Transition as concerns on the care plan. However, there was no evidence the facility developed a care plan for Patient #2 to address the patient's Infection.

Review of Patient #2's nursing notes for 01/05/19 at 6:10 PM revealed the patient had pain/discomfort in his/her chest that was a "7" out of "10" rating. The nurse documented that the provider would be notified and to refer to new orders. There was no documented evidence the patient's care plan was revised when the patient experienced chest pain.

Review of Patient #2's EKG dated 01/05/19 at 6:38 PM revealed the patient had "T wave abnormality", to consider anterior and inferior ischemia (reduced blood flow), and had a prolonged QT interval. The EKG results revealed the test was abnormal.

Review of the Troponin I results for Patient #1 revealed on 01/05/18 at 7:43 PM the result was 0.296 ng/mL, on 01/06/19 at 1:41 AM revealed the level was 0.231 ng/mL, and on 01/06/19 at 8:03 AM the patient's result was 0.251 ng/mL (reference range was 0.04-0.779 ng/mL indicates an indeterminate range, suspicious of MI and clinical correlation required). In addition, further review of Patient #2's laboratory results revealed the patient's C-Reactive Protein was abnormal on 01/05/19 at 7:56 PM was 5.72 mg/L (greater than 2.0 mg/L indicates severe inflammation and can be elevated in acute or chronic inflammatory conditions, tissue injury, ischemia or infarction [decreased or lack of blood supply, such as what occurs with a heart attack], or infection).

Continued review of Nursing Notes revealed on 01/05/19 at 8:36 PM, RN #1 notified Physician #6 via telephone regarding Patient #2's EKG results, cardiac marker results, and that the patient's chest pain had improved (five on a scale of 0-10). The nurse documented no new orders were obtained. However, there was no documentation a care plan was developed/implemented to address the patient's chest pain or abnormal test results.

Interview with Registered Nurse (RN) #1 on 04/18/19 at 11:50 AM revealed at approximately 6:00 PM on 01/05/19, Patient #2 complained of chest pain and the RN contacted Physician #6 (a psychiatrist). RN #1 stated Physician #6 ordered an EKG and cardiac markers and she notified the physician when the test results came back abnormal. RN #1 stated her shift ended at 7:00 PM that evening, but she stayed later to complete documentation and notified Physician #6 of the first set of abnormal results before she went home.

Attempts to interview RN #10 (who was working the night shift on 01/05-06/19 when Patient #2's Troponin levels were abnormal) were conducted on 04/18/19 at 11:45 AM, 04/22/19 at 10:00 AM, and on 04/25/19 at 12:35 AM without success.

Interview with RN #1 on 04/18/19 at 11:50 AM revealed that to her knowledge, nurses on the behavioral health unit did not address medical issues on a patient's plan of care. RN #1 stated she was unsure whether it was even an option.

Interview with the Director of Behavioral Health on 04/23/19 at 2:00 PM revealed nursing and therapy staff developed plans of care for the patients on the Behavioral Health unit; however, it had not been practice to identify and address the patient's medical needs on the plans of care.

Review of a Progress Note dated 01/08/19 at 4:45 PM revealed Physician #3 documented he was called to psychiatry unit for a "Code Blue" for Patient #2. Patient #2's nurse reported the patient had been experiencing generalized weakness and his/her blood pressure had been running low. Patient #2 was in the shower "when [his/her] eyes just rolled back and [he/she] went unresponsive." Patient #2 was pulseless, apneic (not breathing), unresponsive, cyanotic (blue), with dilated, unreactive pupils and Pulseless Electrical Activity. The Progress Note stated Advanced Life Support (ALS) protocol was followed. However, despite their efforts, Physician #2 documented that Patient #2 was showing an agonal PEA rhythm on the monitor, resuscitative effort was terminated, and Patient #2 was pronounced dead.

EMERGENCY SERVICES

Tag No.: A1100

Based on record review, interview, and review of the facility's protocol, it was determined the facility failed to ensure the emergency needs of patients was met for Patient #3 and Patient #6. Patient #3 and Patient #6 presented to the Emergency Department (ED) and the facility obtained cultures. The patients were discharged from the ED prior to receiving the results of the cultures, which were later determined to be positive. Interview with staff and review of the facility's protocol revealed the facility's protocol was to contact the patient via telephone to notify the patient of the adverse laboratory test results in order to ensure the patient received appropriate medical treatment as indicated. If unable to reach the patient via telephone, the facility sent the patient notification via regular and certified mail. However, based on the interviews and the protocol there was no specified time-frame to notify the patients.

On 07/11/18, the facility obtained a urine culture result for Patient #3 who the facility had discharged from the ED on 07/08/18. The results of the culture revealed the patient had E-Coli. However, the facility did not attempt to notify the patient via phone of the results until 7/19/18, which were unsuccessful. In addition, the facility did not send written notification via mail until 07/26/18.

On 11/21/18, the facility obtained stool culture results for Patient #6, which revealed Campylobacter antigens (when present indicates a Campylobacteriosis infection is present which is often caused by food-borne illness). However, the facility failed to notify the patient of the results via phone until 11/22/18 and documented the patient did not answer. The facility made no further attempt to contact the patient until 12/05/18 when a letter was sent.

EMERGENCY SERVICES POLICIES

Tag No.: A1104

Based on record review, interview, and review of the facility's policies, procedure and protocols, it was determined the facility failed to ensure the medical staff's responsibility of care continued to meet the needs of Patient #3 and Patient #6, who were provided care in the Emergency Department (ED). Interview with staff revealed the facility's protocol was to contact the patient via telephone to notify the patient of the adverse laboratory or diagnostic test results in order to ensure the patient received appropriate medical treatment. If staff are unable to reach the patient via telephone, the facility sends the patient notification via routine and certified mail.

On 07/11/18, the facility obtained a urine culture result for Patient #3 who the facility had discharged from the ED on 07/08/18. The results of the culture revealed the patient had E-Coli. However, the facility did not attempt to notify the patient via phone of the results until 7/19/18, which were unsuccessful. In addition, the facility did not send written notification via mail until 07/26/18.

On 11/21/18, the facility obtained stool culture results for Patient #6, which revealed Campylobacter antigens (when present indicates a Campylobacteriosis infection is present which is often caused by foodborne illness). However, the facility failed to notify the patient of the results via phone until 11/22/18 and documented the patient did not answer. The facility made no further attempt to contact the patient until 12/05/18 when a letter was sent via mail.

The findings include:

Review of a "Standard Worksheet/Job Instruction Sheet" not dated for the ED revealed each day the Mid-Level Provider (non-physician primary care providers such as nurse practitioners and physician assistants) would check their in-mail in Epic (the system utilized by the facility for electronic health records) for any abnormal test results received for previously discharged patients. If the provider identified any abnormal results, they were responsible for attempting to contact the patient three times, and document a note in the computer system regarding the contact prior to the end of their shift. Further, the worksheet stated the provider would generate a message in Epic, which would include a treatment plan for the patient. In addition, the worksheet stated the provider was to notify the ED office manager if contact with the patient was unsuccessful. The ED office manager would then be responsible to send the patient notification via regular and certified mail informing the patient to contact the ED and would make a note in Epic of the action taken. The worksheet did not detail timeframes for the provider to utilize when contacting patients was deemed necessary.

1. Review of Patient #6's medical record revealed the patient presented to the ED on 11/19/18 at 11:58 PM with complaints of bilateral lower extremity swelling, chest pain, abdominal pain and distension, nausea, vomiting and diarrhea.

Continued review of Patient #6's medical record revealed the physician ordered a stool culture for the patient on 11/20/18 at 1:38 AM, and the specimen was obtained from the patient on 11/20/18 at 1:51 AM. Continued review of the medical record revealed the laboratory notified the facility on 11/21/18 at 12:39 PM that Patient #6's stool culture was positive for Campylobacter antigens. However, the facility discharged Patient #6 on 11/20/18 at 5:36 AM prior to receiving the results of the stool culture.

Further review of Patient #6's record, revealed staff documented they attempted to call the patient on 11/22/18 at 8:07 PM, however the patient did not answer the phone and no further attempts were made to call the patient as required by the facility's worksheet. In addition, Patient #1's medical record revealed the facility did not send a letter to the patient's address regarding the results of the stool culture until 12/05/18 at 1:43 PM fourteen (14) days after the facility received the stool culture results, which indicated the presence of Campylobacter antigen. Review of the Certified Mail Receipt revealed the patient's family signed for the letter on 12/17/18.

Continued review of Patient #6's medical record revealed on 11/20/18 at 7:24 AM the patient called the ED regarding the certified letter. According to the record, staff advised the patient of the stool culture results and called in a prescription to the patient's pharmacy for an antibiotic.

Interview with Patient #6 on 04/23/19 at 2:15 PM revealed the patient stated that he/she had never received a call from the facility regarding the laboratory test results. However, the patient stated he/she did receive a certified letter from the facility regarding the laboratory test results approximately one month after the visit to the ED and stated, "By that time, I was feeling better".

2. Review of Patient #3's medical record revealed the patient presented to the ED on 07/08/18 with complaints of chest pain, left ankle pain and a headache after sustaining a fall four days prior. The record stated the patient had experienced nausea, vomiting and a syncopal (fainting) episode while using the toilet resulting in unconscious for approximately twenty (20) to thirty (30) minutes. Further review of the record revealed the facility obtained a urine sample from the patient on 07/08/18 at 6:56 PM. Further review of Patient #3's medical record revealed the laboratory notified the facility of the results of Patient #3's urine culture on 07/11/18 at 11:25 AM, which indicated the culture was positive for Escherichia Coli (E-Coli). However, the facility had discharged Patient #3 on 07/08/18 at 8:46 PM.

Continued review of Patient #3's medical record revealed there was no evidence found to indicate the facility attempted to contact the patient for notification of the culture results. On 07/19/18, eight (8) days after receipt of the urine culture, a physician documented "please notify [patient] and call in Augmentin (antibiotic)." According to the patient's record, after the physician made the documentation to contact the patient, a physician assistant (PA) documented that he attempted to call the patient three (3) times on 07/19/18, however, the PA documented he did not get an answer, but left a voice message. Further review of the record revealed there was no further attempts made to contact the patient via phone. Continued review revealed on 07/26/18, the facility sent a letter to the patient, which was signed for on 08/01/18, indicating receipt twenty (20) days after the facility obtained the results of the urine culture.