Other·March 29, 2023

T22 DIV5 CH3 ART5 72523 Administrative Policies and Procedures (a) Written patient care policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved (b) All policies and procedures required of these regulations shall be in writing, made available upon request to physicians and other involved health professionals, patients or their representatives, employees and the public shall be carried out as written. Policies and procedures shall be reviewed at least annually, revised as needed and approved in writing by the patient care policy committee. On 8/27/19 at 7:30 a.m., an unannounced visit was conducted at the facility to investigate a complaint regarding an unexplained death at the facility. The Department determined the facility failed to adhere to established facility policy and procedures for care of Resident 1 when: 1. The secondary alarm (an auditory and visual notification system designed to alert staff of resident problems in the hallway) for a ventilator (a machine designed to provide mechanical breathing by moving air into and out of the lungs when a person is unable to perform the function for themselves) was disabled by facility staff. 2. The primary ventilator (on the machine itself) alarm was reduced to the minimum auditory level by facility staff; and 3. The parameter for the abnormal respiration (breathing) rate alarm for Resident 1 was set by facility staff at 60 breaths per minute, too high to be effective (normal adult respiratory rate at rest is 12-25 breaths per minute). These failures led to the brain injury and subsequent death of Resident 1 after his ventilator tubing (the tubing that carries air from the ventilator to the patient's lungs) became disconnected and deprived Resident 1 of oxygen necessary for life when the alarm system failed to protect Resident 1 because it was disabled by facility staff. Findings: Resident 1 had resided at the facility for approximately two years with diagnoses that included acute and chronic respiratory failure with hypoxia (not having enough oxygen in the blood); he was ventilator-dependent (must use a mechanical ventilator to breathe). The 8/9/19 Respiratory Assessment indicated Resident 1 was alert and cooperative, his color was pink, and his respiration rate was 26 on the ventilator. 1. During an interview with Licensed Vocational Nurse (LVN) 1 on 8/27/19 at 7:55 a.m., she stated on 8/15/2019 at the beginning of her shift around 6:30 a.m., as she was organizing her cart in front of room 408, she heard a pulse oximeter (device used to measure the oxygenation of the blood) alarm and ventilator alarm. LVN 1 stated she had never heard these 2 alarms go off at the same time (indicating Resident 1 was not receiving enough oxygen). She stated she looked up at the monitor mounted at the end of the hallway and noticed there was no reading. She stated she looked in Resident 1's room and noticed Resident's eyes were closed and his skin was pale. She stated she called out "[Resident 1]!" and noticed "...the [ventilator] tubing was disconnected from the ventilator..." She recalled the pulse oximeter and ventilator displays were both flashing and a whooshing sound was coming from the ventilator tubing. LVN 1 stated she reconnected the tubing, got the attention of the Respiratory Therapist (RT) 1, and they initiated CPR while a student RT was sent to the nurse station to initiate a code blue (a medical emergency situation when emergency medical services (EMS) is contacted, and emergency services are requested). During an interview with RT 2 on 9/24/19 at 10:55 a.m., she stated she had begun her shift at 6:00 a.m. on 8/15/2019, and had just finished speaking with the outgoing RT. Her cart was set up near the cart of LVN 1. She stated that is when LVN 1 got her attention regarding Resident 1, she could not remember seeing or hearing an alarm in the hallway. RT 2 stated the lights on top of the ventilator of Resident 1 were flashing (indicating an audible alarm should be heard). On 8/27/19, email correspondence with Vendor 1 (representative for the ventilator monitoring/alarm system company) included attached reports referred to as, "Room Detail" for the ventilator of Resident 1. The email from Vendor 1 stated, "We've double-checked the connection data and confirmed what shows in the reports". The Room Detail included the ventilator data from 8/11/19 through 8/15/19. The report indicated the hallway alarm, also known as the secondary alarm, for Resident 1 was disconnected on 8/14/19 at 10:02 a.m. and not reconnected until 8/15/19 at 7:00 a.m., 25 minutes after the initiation of the code blue for Resident 1. During a confirmatory phone interview with Vendor 1 on 8/27/19 at 1:25 p.m., he confirmed that Resident 1's alarm for the hall display was disconnected from 8/14/19 at 10:02 a.m. until 8/15/19 at 7:00 a.m., as indicated on the above-mentioned Room Detail report. During an interview with RT 1 on 8/27/19 at 8:20 a.m., he stated the hallway alarm system should sound if the ventilator tubes become disconnected. The facility policy and procedure titled "Clinical Alarms - Maintenance and Use of" dated 1/1/14, indicated, "All clinical alarms and medical equipment alarm systems utilized for patient care shall be properly operational and alarms are activated when the appropriate settings are in use." The facility policy and procedure titled "Ventilator Maintenance/Monitoring - Recommended Parameters" dated 1/1/14, stipulated, "A patient-ventilator maintenance/monitoring shall be performed by an RT every four (4) hours for those patients requiring mechanical ventilation for life support. Patient-ventilator checks for all other patients shall be performed every 4 hours. In addition, a check shall be performed: ... After any changes in ventilator settings..." Furthermore, the policy noted, "Patient-ventilator maintenance/monitoring shall be a documented evaluation of a mechanical ventilator and of the patient's response to mechanical ventilator support. This procedure is often referred to as a ventilator check...Objectives... Verify and document that alarms are operational prior to use and at least once per shift when the ventilator is in use...That alarms for airway disconnection and other system disturbances are functional and are set correctly and turned on." During an interview with RT 3 on 9/25/19 at 12:55 p.m., she stated there were 7 ventilator checks that they were performing (each shift to ensure all aspects of the ventilator are functional) prior to 8/15/19 but..."At that time we weren't doing [every] 1 [hour] checks to make sure the secondary alarm is plugged in...". 2. During a phone interview with Vendor 2 (representative for the ventilator company) on 9/9/19 at 10:40 a.m., he stated, upon inspection of Resident 1's ventilator machine on 9/9/19, the manually adjusted volume on the ventilator, which may be set from 1-10, was set at its lowest setting of 1. He could not state when the volume setting was adjusted or by whom. During an interview with RT 4 on 9/10/19 at 1:00 p.m., she stated, "The machine alarms should be [set] at 10, or full volume, because that is the first [ventilator] alarm." During a phone interview with LVN 2 on 9/9/19 at 1:40 p.m., she stated she participated in the code after she found out Resident 1 was unresponsive and "During the code, I didn't hear any alarms." During a phone interview with Registered Nurse (RN) 1 on 9/9/19 at 1:55 p.m., she stated, "I did not hear an alarm during the code." RN 1 stated she was on the unit in another resident's room. During an interview with RT 3 on 9/25/19 at 12:55 p.m., she stated there were 7 ventilator checks that they were performing (each shift to ensure all aspects of the ventilator are functional) prior to 8/15/19 but..."At that time we weren't doing [every] 1 [hour] checks to make sure the...primary alarm volume is set at 10." The facility policy and procedure titled "Ventilator Maintenance/Monitoring - Recommended Parameters" dated 1/1/14, indicated, "...Documentation shall include...Documentation that alarms can be heard in the surrounding patient care environment by staff." The Respiratory Therapists were responsible to document the presence of the alarms. 3. During a phone interview with Vendor 2 (representative for the ventilator company) on 9/9/19 at 10:40 a.m., he stated, upon inspection of Resident 1's ventilator machine on 9/9/19, the manually adjusted respiratory rate alarm, to notify staff of abnormal breathing, was set at 60 breaths per minute. 60 breaths per minute would have been too high to be effective as a normal adult respiratory rate at rest is 12-25 breaths per minute. During an interview with RT 3 on 9/25/19 at 12:55 p.m., when referring to the upper limit setting for respiration rate alarm, stated, "Everybody was at 45, that's where they should have been." During an interview with RT 4 on 9/10/19 at 1:00 p.m., when asked why the respiration rate alarm on the ventilator would be set at 60, she stated, "So it would not alarm." The facility policy and procedure title "Ventilators - Guidelines" dated 1/1/14, indicated, "Ventilator changes are to be made only with a physician's order and by the Respiratory Therapist. All changes must be documented (by the Respiratory Therapist) on the ventilator flow sheet...Routine ventilator rounds/checks are to be made and documented every six (6) hours on the ventilator flow sheet." A request was made to the Director of Nursing to provide documentation of primary and secondary alarm checks and respiration rate alarm changes; no documentation was provided. According to the Prehospital Care Report Summary (ambulance report), dated 8/15/2019, EMS arrived at the facility at 6:47 a.m. and found Resident 1 in his bed with facility staff performing (CPR). The report indicted EMS assessed his heart rhythm and found it to have electrical activity but not pumping blood, a condition called pulseless electrical activity, or PEA. CPR was continued and Resident 1 was provided air through his tracheostomy (an artificial opening into the trachea created for long-term use of a ventilator) via a bag-valve mask (a hand-held device used to provide artificial ventilation to patients who are not breathing or who are not breathing adequately). The report noted after 5 minutes of CPR, Resident 1 had a return of circulation, he was transferred onto a gurney and transported to a local hospital. During transport, it was noted, Resident 1 went back into cardiac arrest (a cessation of functional heart activity). The report indicated after 2 minutes of CPR and a dose of Epinephrine (a drug that increases heart rate and contractility and relaxes the smooth muscles around the lungs which improves breathing), Resident 1's circulation returned. The report noted EMS arrived at the local hospital at 7:06 a.m. According to the "ED Progress Note", filed on 8/16/19, upon examination at the hospital emergency department (ED), Resident 1's was described as obtunded (reduced reactivity to stimuli and reduced consciousness) and pupils were minimally reactive (typically pupils would be highly reactive to light). Resident 1 did not follow commands and he did not move his extremities. Resident 1's condition upon transfer from the ED to the intensive care unit (ICU) was documented as "guarded." The "H & P [History and Physical]" Note, dated 8/15/19, indicated upon arrival to the hospital Resident 1 was, "hypotensive (low blood pressure), hypothermic (low body temperature), and unresponsive". The note included the Physician's physical examination in the ICU of Resident 1 noting his mental status as, "spontaneous eye opening with no eye contact or visual pursuit". The nervous system assessment of Resident 1 was documented as the pupils were measuring at 3 mm and equally sluggish on both sides; he had no gag reflex (a reflex contraction of the back of the throat; it is a form of coughing to prevent choking) and did not withdrawal or posture when pain was applied to his extremities (the withdrawal reflex is involuntary and is meant to protect the body from damaging stimuli). Resident 1's deep tendon reflexes (large muscle contractions as a result of stimuli) were documented as flaccid (no movement) for all for extremities. The "Active ICU problems/plans" section of the H & P indicated, "1. Cardiac arrest. Likely due to a respiratory event. Initial rhythm unknown but patient was pulseless when found. Downtime is unknown but likely considerable given initial lactate [acid made in the body as a result of lack of oxygen] of 7.6 and hypoxic [without oxygen] myoclonus [shock-like contractions of muscle] ..." A discussion was documented in the H &P note regarding Resident 1's code status. The physician documented, "Discussed with patient's wife [name] and daughter [name]. Informed them patient is not a good candidate for aggressive resuscitation. We discussed partial code to avoid a traumatic end of life. They agreed.", "I informed family that goals of care will be revisited if 1) [Resident 1] deteriorates hemodynamically [inability to maintain appropriate blood pressure and/or heart rate to sustain life] or from respiratory standpoint despite maximum medical therapy, or 2) He fails to regain meaningful neurological recovery after TTM [targeted temperature management - a treatment that attempts to achieve and maintain a specific body temperature, for a specific period of time, in an effort to improve health outcomes during recovery after a period of stopped blood flow to the brain.]...They verbalized understanding." The hospital Discharge Summary, dated 8/22/19, indicated, "...On the morning of 8/15/19, [Resident 1] was found to be unconscious and pulseless. He was resuscitated x 2 and brought to the ED. He was found to be hypotensive, hypothermic, and unresponsive....", "... [Resident 1] has been unable to regain consciousness, except for spontaneous eye opening, no tracking or following commands....", and, "per family discussions, he was transitioned to comfort care (comfort focused care with no further resuscitative efforts) on 8/22/19 and passed away." The Certificate of Death, issued on 9/27/2019, listed Resident 1's immediate cause of death as, "Cardiac Arrest". The underlying causes leading to the immediate cause was listed as, "Acute on Chronic Respiratory Failure." An associated diagnosis was Anoxic Encephalopathy (which means "no oxygen" and is a condition where brain tissue is deprived of oxygen and there is global loss of brain function. In violation of the above cited standards, the facility failed to ensure written patient care policies and procedures were implemented to ensure that patient related goals and facility objectives are achieved. These violations, jointly, separately or in any combination, presented either an imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result, and were a direct proximate cause of death of a patient or resident.