The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MEDICAL CENTER OF THE ROCKIES 2500 ROCKY MOUNTAIN AVE LOVELAND, CO 80538 May 11, 2020
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on the nature of the standard level deficiency, it was determined 482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance.

A-0749- The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews and document reviews, the facility failed to ensure staff followed Center for Disease Control (CDC) infection control guidelines by not actively screening health care personnel for signs and symptoms of COVID-19, a highly infectious disease, prior to the start of their shift. Additionally, the facility failed to follow CDC guidelines for the screening of visitors upon entry to the facility, to prevent the spread of COVID-19.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, interviews and document reviews, the facility failed to ensure staff followed Center for Disease Control (CDC) infection control guidelines by not actively screening health care personnel for signs and symptoms of COVID-19, a highly infectious disease, prior to the start of their shift. Additionally, the facility failed to follow CDC guidelines for the screening of visitors upon entry to the facility, to prevent the spread of COVID-19.

Findings include:

Reference:

According to the CDC's Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Health Care Settings, updated April 13, 2020, a facility should actively screen anyone entering the health facility for fever or symptoms of COVID-19. All healthcare personnel should be screened at the beginning of their shift by actively checking their temperature for the absence of fever and documenting the absence of symptoms consistent with COVID-19. Additionally, the facility should actively assess all visitors for symptoms of COVID-19 to include fever, shortness of breath (SOB) and cough upon entry to the facility. The visitor should not enter the facility if they have a fever or COVID-19 symptoms.

1. The facility failed to ensure healthcare personnel were actively screened prior to their shift to include, taking their temperature and documenting the absence of symptoms consistent with COVID-19 in order to prevent the spread of COVID-19.

a. On 5/4/20 at 1:02 p.m., an interview was conducted with Registered Nurse (RN #11) who was providing patient care on the cardiology unit. RN #11 stated she did not actively check her temperature prior to the start of her shift, nor did she document the absence of COVID-19 symptoms. RN #11 further stated no one at the facility actively screened her prior to the start of her shift.

b. On 5/7/20 at 3:02 p.m., an interview was conducted with the infection preventionist (IP #16). According to the facility's Infection Prevention and Control Plan, the role of the IP was to use evidence-based national guidelines to institute control measures to prevent the transmission of infectious diseases. IP #16 stated it was important to follow CDC guidelines because there was research behind the guidelines and the guidelines were evidence based. IP #16 stated the facility did not actively screen health care personnel prior to the start of their shift, rather staff were to self-monitor prior to coming to work.

c. On 5/7/20 at 2:30 p.m., the Assistant Director of Employee Health (Director #13) was interviewed. Director #13 stated staff self-monitored for symptoms and were not to report to work if sick. Director #13 was unable to confirm the facility's adherence to the outlined requirement as there was no active screening process for the health care personnel prior to their shift currently. Director #13 stated staff self-monitoring was acceptable under CDC guidance. Director #13 stated there was not a high risk to patients if the staff screening process was not followed due to social distancing measures and the requirement of staff to wear a surgical mask when providing patient care.

The process of staff self-monitoring and no active screening of staff outlined by Director #13 was in contrast to CDC guidelines which read, to decrease the spread of COVID-19, all healthcare personnel should be screened at the beginning of their shift to include checking their temperature for the absence of fever and document the absence of symptoms consistent with COVID-19.

d. Information provided by Employee Health was reviewed. The information read, due to the implementation of social distancing and requirement of a surgical mask to be worn by staff, temperature checks were not seen as required. The guidance from Employee Health stated staff were to not come to work with a fever of 100.4 F or greater and/or if the staff members was experiencing upper respiratory symptoms. The Employee Health information provided acknowledged employees were not actively taking temperatures prior to their shift at current time. The guidance was in contrast to CDC recommendations as stated above.

2. The facility failed to follow Center for Disease Control (CDC) recommendations by screening visitors entering the facility to prevent the transmission of COVID-19.

According to the CDC's Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Health Care Settings, updated April 13, 2020, the facility should actively assess all visitors for fever and COVID-19 symptoms upon entry to the facility.

a. On 5/4/20 at 11:30 a.m., surveyors entered the facility at the main hospital entrance. Observations upon entry revealed, the facility greeter did not ask surveyors any screening questions to ensure the surveyors were not experiencing symptoms of COVID-19. Furthermore, the surveyor's temperatures were not taken to ensure they were not experiencing any fever.

b. Review of the For Patients and Visitors sign posted at the facility read, all visitors will be screened for symptoms of COVID-19 before being allowed to enter. Visitors with any symptoms were not allowed to enter the facility.

c. On 5/6/20 at 4:10 p.m., an interview was conducted with Greeter #14. Greeter #14 stated she was responsible for ensuring visitors and patients had a mask on in order to prevent the spread of COVID-19. Greeter #14 stated she only screened patients or visitors entering the facility if they did not have a mask on. Greeter #14 stated if a visitor had a mask on, she would not ask the COVID-19 screening questions. Greeter #14 stated the previously stated process was her process and was not documented anywhere as guidelines to follow. Greeter #14 stated she did not screen surveyors because they were wearing face masks.

Greeter #14 stated it was important to follow the screening process to protect patients and staff members from COVID-19. The process followed by Greeter #14 was in contrast to CDC guidelines which recommended all patients and visitors should be asked if they were experiencing a fever, cough or SOB upon entering the facility. Visitors with symptoms should not be permitted in the facility.

d. On 5/7/20 at 2:10 p.m., and interview was conducted with Supervisor #15. Supervisor #15 stated she created the patient and visitor screening process guidance for the greeters. Supervisor #15 stated any person entering through the main entrance or emergency department (ED) should be screened to include asking if the person had a fever or was experiencing shortness of breath or a cough. Supervisor #15 stated if patients and visitors were not screened appropriately the result could be spread of COVID-19 in the facility. Supervisor #15 stated the screening process was not followed when surveyors entered the facility because the surveyors should have been screened. Additionally, Supervisor #15 stated every patient or visitor who entered the facility needed to be screened, regardless of if the person had a mask on or not.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation 482.13, PATIENT RIGHTS, was out of compliance.

A-0144 The patient has the right to receive care in a safe setting. Based on interviews and document review, the facility failed to ensure a safe environment of care for a patient. Specifically, a delay occurred in a patient receiving care after experiencing a lethal cardiac arrhythmia and the patient expired. This failure occurred in 1 of 1 code blue records reviewed (Patient #1).
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, the facility failed to ensure a safe environment of care for a patient. Specifically, a delay occurred in a patient receiving care after experiencing a lethal cardiac arrhythmia and the patient expired. This failure occurred in 1 of 1 code blue records reviewed (Patient #1).

Facility policy:

The Clinical Alarms policy read, staff should verify clinical alarm parameters are appropriate and audible on initiation and throughout care episodes. Life Sustaining Equipment/Crisis Alarms require immediate assessment/attention. Inattention to this alarm may result in a devastating clinical event including, but not limited to staff assist/code notification and lethal dysrhythmia/telemetry (red alarms). Suspend or silence options are used temporarily to assess the patient's condition and/or the cause of the alarm. This suspension contributes to diminishing alarm noise during active assessments. Clinical staff receive department-specific education on Clinical Alarm Systems. Systems and equipment education includes alarm purpose, operation, response, management of false and nuisance alarms and soft or customized alarm setting. Definitions include: Clinical Alarm: A patient generated or activated audible and/or visual notification that a patient's immediate physiological or health status is, or could be, life threatening. Equipment with clinical alarm systems include, but are not limited to: ECG monitors.

The Code Blue, Cardiac or Respiratory Arrest policy read, the facility shall maintain a coordinated mechanism to respond quickly and effectively in the event that any person on the premises has a cardiac or respiratory arrest (Code Blue). Procedure Details: Call the Code Blue Team for any person without a pulse or respiration or with acute hemodynamic instability and/or acute respiratory distress when intervention is required. Initiate cardiopulmonary resuscitation (CPR) and defibrillator application. The Registered Nurse (RN) will defibrillate (deliver electrical shock) shockable rhythms with the defibrillator depending upon location and competency of staff. An advanced cardiac life support (ACLS) trained nurse from the Emergency Department (ED) and Intensive Care Unit (ICU) will respond. The ICU RN is the Chief Code Blue Team Nurse, ensuring all team members assume a resuscitation role, each role is performed effectively, and coordinates resources and communication.

The Critical Care Adult Standing Orders, ACLS Guidelines for ICU read, for pulseless VT or VF, defibrillate with 200 joules. Repeat at 200 joules if dysrhythmia continues with two minutes of CPR between defibrillation's.

References:

The American Heart Association ACLS provider manual read, the interval from collapse to defibrillation is one of the most important determinants of survival from cardiac arrest. Early defibrillation is critical for patients with sudden cardiac arrest for the following reasons: Pulseless [DIAGNOSES REDACTED] (VT) rapidly deteriorates to ventricular fibrillation (VF). When VF is present, the heart quivers and does not pump blood. Electrical defibrillation is the most effective way to treat VF (delivery of a shock to stop the VF). The probability of successful defibrillation decreases quickly over time. VF deteriorates to asystole if not treated. The earlier defibrillation occurs, the higher the survival rate. When VF is present, CPR can provide a small amount of blood flow to the heart and brain but cannot directly restore an organized rhythm. The likelihood of restoring a perfusing rhythm is optimized with immediate CPR and defibrillation within a few minutes of the initial arrest. For every minute that passes between collapse and defibrillation, the chance of survival from a witnessed VF sudden cardiac arrest declines by 7% to 10% per minute if no bystander CPR is provided.

The Adult Cardiac Arrest 2015 Algorithm states to start CPR and attach a monitor/defibrillator. If the rhythm is VF or VT it is a shockable rhythm. A shock (defibrillation) should be delivered, then resume CPR for two minutes. Recheck rhythm after two minutes, determine if it is a shockable rhythm.

1. The facility failed to ensure staff did not pause alarms which would allow staff to be alerted and respond to a lethal cardiac arrhythmia. An unknown staff personnel paused the telemetry monitor in Patient #1's room. The patient experienced a lethal arrhythmia and due to the paused alarm, staff were not alerted to the lethal arrhythmia.

a. Interviews with staff revealed, on 4/22/20 at 3:39 p.m., Patient #1 developed [DIAGNOSES REDACTED]. Patient #1's telemonitor alarms had been paused and due to the paused alarm, staff responsible for monitoring the patient's telemonitor monitor were not alerted to the lethal arrhythmia.

i. On 5/6/20 at 11:36 a.m., an interview with Registered Nurse (RN) #3 was conducted. RN #3 stated she normally worked in the observation unit, but was acting as a safety companion sitter for Patient #1 on 4/22/20 in the Surgical Progressive Care Unit (SPCU). She stated Patient #1 had been agitated intermittently throughout her shift and did require frequent repositioning in the bed. RN #3 stated Patient #1 was agitated and as she was getting him settled in the bed, he froze with his eyes opened and did not respond when she called his name. She stated she did not feel for a pulse, but looked at the monitor and saw the patient was in [DIAGNOSES REDACTED] (VT), so she pulled the code blue button to get staff assistance. RN #3 stated she did not remember if she had paused the alarm or if it was sounding at the time he became unresponsive. RN #3 stated she had not received any education related to pausing cardiac alarms.

ii. On 5/6/20 at 1:15 p.m., RN #6 was interviewed. RN #6 was the charge nurse on duty in SPCU on 4/22/20. She stated the staff monitored their own telemetry monitors in the SPCU. RN #6 stated the monitor would alarm if a patient had an arrhythmia. She stated staff could silence the alarm when caring for a patient and the monitor would still sound if the patient had a lethal cardiac arrhythmia. RN #6 stated alarms could only be paused at the bedside by an RN who was actively monitoring the patient and their rhythm, since a paused alarm would not sound if the patient had a lethal cardiac arrhythmia. She stated on 4/22/20, she was at the nurse station discussing another patient's cardiac rhythm with staff when she went to the telemetry monitor to look at the rhythm. It was then, she noticed Patient #1 was in VT. RN #6 stated she remembered the event well because an alarm did not sound which was unusual for a VT rhythm. She stated she turned toward Patient #1's room and saw the code blue alarm on from Patient #1's room and the door closed. RN #6 stated she had not received any education related to pausing cardiac alarms.

b. Review of telemetry strips for Patient #1 revealed he presented with sustained VT on 4/22/20 at 3:39 p.m. The Code Blue record revealed a code blue was called at 3:41 p.m., two minutes after Patient #1 presented with VT.

c. Document review revealed Clinical Nurse Specialist (CNS) #8 had identified concerns related to Patient #1. On 4/28/20, CNS #8 had reviewed Patient #1's medical record, telemonitor strips and alarms. On conclusion of her review, CNS #8 had identified several concerns to include staff in Patient #1's room had paused the alarms leading staff who were responsible for the monitoring of Patient #1 to be unaware Patient #1 was experiencing a lethal cardiac arrhythmia.

On 5/6/20 at 2:45 p.m., Clinical Nurse Specialist (CNS) #8 was interviewed. CNS #8 stated she reviewed every code blue record. She stated when she reviewed Patient #1's code blue record which included a review of telemetry strips, she noticed alarms were paused on 4/22/20 at 3:39 p.m., which was two minutes before the code was initiated at 3:41 p.m. She stated she determined Patient #1 was in [DIAGNOSES REDACTED]at 3:39 p.m., and the alarm was paused from the monitor inside the patient room at that time. CNS #8 stated pausing the alarm instead of silencing the alarm was an over response, because staff would not be notified of a lethal cardiac arrhythmia. CNS #8 stated during the same minute the alarm was paused, at 3:39 p.m., Patient #1 changed into VT. She stated the alarm being paused is what resulted in the alarms at the nurse's station not to sound.

CNS #8 stated her role was to review the medical record and inform risk management what she had identified and what staff education needs were. She stated risk management then performed an investigation. She stated she did not interview staff, so she did not duplicate the risk management review effort. CNS #8 stated she finished her investigation within a couple of days and informed risk management the day her investigation was complete. She stated risk management was going to perform a root cause analysis (RCA) on who paused the alarms, therefore, no actions would take place until the RCA was completed.

d. On 5/7/20 at 1:02 p.m., an interview was conducted with Risk Management RN (RN) #9. RN #9 stated her role was to look at high harm events and patient harm issues and perform investigations to understand if the facility had a process problem. RN #9 stated CNS #8 brought her concerns about Patient #1 as soon as she had identified any concern related to the alarms being paused. RN #9 stated she reviewed the investigation CNS #8 had provided her and saw the delay in starting cardiopulmonary resuscitation (CPR) as a red flag. RN #9 stated she interviewed RN #3 and RN #6 to investigate the paused alarms. She stated she did not provide education, the RN's nurse manager would provide education. An RCA was scheduled for 5/22/20, one month after the event.

RN #9 stated managers were told to educate their staff about pausing alarms in a safety huddle after the event. Safety Huddle meeting minutes were reviewed from 4/22/20 to 5/7/20. There was no evidence the safety issue of paused alarms was discussed.

e. On 5/7/20 at 3:29 p.m., Manager of Regulatory Standards (Manager) #10 stated she was unable to provide evidence of staff education or process changes related to paused monitor alarms after the incident with Patient #1.

2. The facility failed to defibrillate Patient #1 until six minutes after presenting with [DIAGNOSES REDACTED] (VT, a lethal cardiac arrhythmia).

a. On 4/22/20 at 3:39 p.m., Patient #1 developed [DIAGNOSES REDACTED]. According to the Code Blue documentation, two minutes later, at 3:41 p.m., a code blue was called. The patient was not defibrillated until 3:45 p.m., six minutes after presenting with VT. This was not in accordance with facility policy and ACLS guidelines, which read for VT the patient should be defibrillated within two minutes and the earlier defibrillation occurs, the higher the patient survival rate. According to staff interviews, the patient was wearing defibrillator pads which led code responding staff to believe the patient had already been defibrillated.

b. On 5/6/20 at 1:15 p.m., RN #6 was interviewed. RN #6 was the charge nurse on duty in SPCU on 4/22/20. RN #6 stated once she became aware of the code blue she immediately responded to Patient #1's room. She stated she saw "textbook" VT on the cardiac monitor. She stated she could tell upon entering the patient's room he was not breathing, so another RN started chest compressions. RN #6 stated she did not check Patient #1's pulse and was not sure the other RN did either. RN #6 stated Patient #1 was wearing defibrillator pads prior to the code being called since they were placed earlier in the day.

RN #6 stated a code was always called for VT whether the patient had a pulse or not. She stated for VT with a pulse, the patient should be defibrillated. RN #6 stated she is not sure if Patient #1 was defibrillated, since she was the charge nurse of the unit, she was assisting other patients intermittently.

c. On 5/6/20 at 2:02 p.m., an interview with RN #7 was conducted. RN #7 was the ICU code nurse that responded to Patient #1's code blue on 4/22/20 at 3:41 p.m. She stated when she arrived at the room CPR was in progress. She stated Patient #1 already had defibrillator pads in place when she arrived. RN #7 stated Patient #1 had poor perfusion which made assessing for a pulse very difficult. She stated for VT arrest the treatment was defibrillation. RN #7 stated she did not pause CPR when she entered the room to assess the rhythm nor did she ask if the patient had been defibrillated. RN #7 stated she made an assumption the patient had been defibrillated. She stated she was not sure what staff did prior to arrival because she didn't ask. She stated the first rhythm she saw on the monitor was at 3:45 p.m., which was VF and the patient received a shock at that time.

According to the ACLS algorithm, Patient #1 should have received an electrical shock with each two minute assessment of a shockable rhythm.

RN #7 stated she was asked questions about Patient #1's code a couple days after by risk management. She stated she had not received any education following the event.

d. On 5/6/20 at 2:45 p.m., Clinical Nurse Specialist (CNS) #8 was interviewed. CNS #8 stated she reviewed every code blue record. She stated when she reviewed Patient #1's code blue record she noticed alarms were paused on 4/22/20 at 3:39 p.m., which was two minutes before the code was initiated at 3:41 p.m. The patient was not defibrillated until 3:45 p.m., which was six minutes after presenting with VT. CNS #8 stated she was not sure why Patient #1 was not defibrillated when the code team arrived at 3:41 p.m. She stated all critical care staff are trained in ACLS protocols, so she was not sure what happened with the responding RN. CNS #8 stated the RN responding to the code should have instructed staff to stop CPR when she entered the room to assess the patient's heart rhythm and not go off the report of what the other staff stated the heart rhythm was. CNS #8 stated all wide complex tachycardia with a heart rate of 150 beats per minute or more should be treated the same as VT which was defibrillation.

CNS #8 stated after her review she determined staff did not defibrillate appropriately to treat VT. She stated there had been no education or follow up to staff after the event. CNS #8 stated an RCA was scheduled and there would be no interventions until after the RCA. CNS #8 stated this code blue would be presented at the code committee meeting which met once a month.

e. On 5/7/20 at 3:29 p.m., Manager of Regulatory Standards (Manager) #10 stated she was unable to provide evidence of staff education or process changes related to paused monitor alarms.