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615 RIDGE RD

ROXBORO, NC 27573

GOVERNING BODY

Tag No.: A0043

Based on review of hospital policy, closed medical record review, and staff interview the hospital's leadership failed to provide oversight and have systems in place to ensure the protection of patients' rights and failed to have an organized nursing service to ensure the provision of patient care in a safe environment.

The findings include:

1. The hospital failed to ensure care in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to respond to a change in a patient's respiratory status, resulting in cardiac arrest and subsequent death of 1 of 3 patients admitted from the Emergency Department (Patient #1).

~cross refer to 482.13 Patient Rights Condition: Tag A0115

2. The hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations to ensure registered nursing staff supervised and evaluated patient care.

~cross refer to 482.23 Nursing Condition: Tag A0385

PATIENT RIGHTS

Tag No.: A0115

Based on review of hospital policy, closed medical record review, and staff interview, the hospital failed to protect and promote patients' rights for a safe environment for patients by failing to ensure care was provided in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to respond to a change in a patient's respiratory status, resulting in cardiac arrest and subsequent death of 1 of 3 patients admitted from the Emergency Department (Patient #1).


The findings include:

1. The hospital failed to ensure care in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to respond to a change in a patient's respiratory status, resulting in cardiac arrest and subsequent death of 1 of 3 patients admitted from the Emergency Department (Patient #1).

~cross refer to 482.13(c)(2) Patient Rights Standard: Tag A0144

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on review of the hospital's medical staff rules and regulations, hospital policy, closed medical record review, and staff interview, the hospital failed to ensure care in a safe setting by failing to ensure the nursing staff supervised and evaluated patient care by failing to respond to a change in a patient's respiratory status, resulting in cardiac arrest and subsequent death of 1 of 3 patients admitted from the Emergency Department (Patient #1).

Findings include:

Review of the hospital's Medical Staff Rules and Regulations revealed, "...ARTICLE XV. EMERGENCY DEPARTMENT SERVICE Section 1: General Policy... D. The Emergency Department Staff physicians will be allowed to write admission orders and admit to a Medical Staff physician's service only after calling that physician for verbal orders. The Medical Staff physician must countersign orders within forty-eight hours. The Medical Staff Attending Physician assumes complete responsibility and care for the patient, at the time the verbal orders are given, despite location of the patient..."

Review of the hospital's policy, "Rapid Response Team", revised 06/2012, revealed, "I. Purpose A. To quickly provide a multidisciplinary medical team approach (Respiratory Therapist, House Supervisor / Nurse Manager) to assess and treat a patient whose condition is deteriorating. In addition, the focus of this team shall be to provide support and education to staff as needed. B. To provide early and rapid intervention in order to promote better outcomes such as: reduced cardiac ad/or respiratory arrests in the hospital; reduced or more timely transfers to a higher level of care; reduced patient intubations; and reduced number of hospital deaths, etc... III. Definitions A. Rapid Response Team - A multidisciplinary team that responds to urgent patient situations throughout the hospital... IV. Policy A. The rapid response team shall be used for all areas outside Physician Services, Sleep Lab, ED (Emergency Department), OR (Operating Room) and PACU (Post Anesthesia Care Unit). This includes the Extended Care Unit. B. Adult Criteria for staff to call the Rapid Response Team is as follows... 4. Acute change in Respiratory Rate (less than 8 or greater than 28) or threatened airway 5. Acute change in oxygen saturation which reflects the percentage of red blood cells saturated with oxygen (level is less than 90% despite oxygen being utilized on the patient) 6. Acute change in Level of Consciousness..."

Review of the closed medical record of Patient #1 revealed a 62 year old female patient (Patient #1) who presented to the hospital's Dedicated Emergency Department (DED) with a chief complaint of chest pain, on May 13, 2015 at 1155. Record review revealed an initial Medical Screening Exam was performed by Medical Doctor (MD) #1, on May 13, 2015 at 1200. Review revealed initial vital signs of Blood Pressure (BP) 118/62 mmHg (millimeters of Mercury) (normal); Pulse 107 BPM (Beats Per Minute) (elevated); Respirations 18 RPM (Respirations Per Minute) (normal); Temperature 98.5 degrees Fahrenheit (normal); Pulse Oximetry 90 % (percent) on room air (decreased); and mental status: alert and oriented (normal); were obtained by Emergency Medical Technician Paramedic (EMTP) #1 on May 13, 2015 at 1202. Record review revealed treatment in the DED consisted of oxygen therapy, cardiac monitoring, 12 lead EKG (Electrocardiogram), Intravenous (IV) access, Albuterol and Atrovent (inhaled medications used to treat shortness of breath) Nebulizer Treatment, Lasix (a medication used to promote the excretion of excess fluid in Congestive Heart Failure) 40 mg (milligrams) IV administration, and Vancomycin (an antibiotic) 1000 mg IV infusion. Review revealed MD #1 consulted MD #2, a hospitalist, via telephone on May 13, 2015 at 1335, in reference to admitting Patient #1 for diagnosis of pneumonia (an infection of the lung) and hypoxemia (deficient oxygenation of the blood). Record review revealed a Bridge Admission Order Set, written on 05/13/2015 at 1345, by MD #1, who ordered, "...1. Admit to service of Dr. (MD #2), Diagnosis: Pneumonia, Status: Admit to Inpatient Services, Location: Med/Surg (Medical Surgical Unit)... Doctor listed above will write additional orders after seeing patient..." Visual inspection of the Bridge Admission Order Set revealed a section of orders with check boxes to issue orders for Monitoring, including cardiac monitoring, and pulse oximetry monitoring; vital sign check frequency, diet, activity, IV therapy, pain management medications, nausea management medications, and antibiotic agent medication. Record review revealed none of this section of the Bridge Admission Order Set was written in or checked. Record review revealed vital signs of BP 123/56 mmHg (normal); Pulse 97 BPM (normal); Respirations 20 RPM (normal); Temperature 97.8 degrees Fahrenheit (normal); Pulse Oximetry 91 % on room air (decreased); and mental status: alert and oriented were obtained by EMTP #1 on May 13, 2015 at 1357. Record review revealed Patient #1 was admitted to room 618 on May 13, 2015 at 1401. Record review revealed Patient #1 was assessed on May 13, 2015 at 1436 by Registered Nurse (RN) #1 who documented, "Pt (patient) transferred to med-surg from ER (Emergency Room) and walked with steady gait to bed. Pt remains anxious and is currently sitting on side of the bed. O2 (Oxygen) 2 LPM (Liters Per Minute) via NC (Nasal Cannula) in place." Record review revealed RN #1 assessed Patient #1's cognitive status as alert and oriented on May 13, 2015 at 1515. Record review revealed vital signs of BP 127/59 mmHg (normal); Pulse 129 BPM (elevated); Respirations 39 RPM (elevated); Temperature 96.1 degrees Fahrenheit (normal); and Pulse Oximetry 97 % (normal) on 3 LPM supplemental Oxygen via NC were obtained by Certified Nursing Assistant (CNA) #1 on May 13, 2015 at 1536. Record review revealed vital signs of BP 96/54 mmHg (decreased); Pulse 105 BPM (increased); Respirations 40 RPM (increased); Temperature 96.1 degrees Fahrenheit (normal); and Pulse Oximetry 88 % (decreased) on 3 LPM supplemental Oxygen via NC were obtained by CNA #1 on May 13, 2015 at 1827. Record review revealed a Nursing Note written by RN #2 on May 13, 2015 at 1930, "Assumed care of patient. Assessment completed. Pt very lethargic and resting at this time. Denied pain or discomfort. Watching TV (television). Will continue to monitor." Record review revealed no documentation that RN #2 reported a change in Patient #1's status to the attending physician. Record review revealed MD #2 entered Patient #1's room on May 13, 2015 at 1950 (5 hours, 45 minutes after admission to the unit) and found Patient #1 unresponsive and in cardiac arrest, at which time Cardiopulmonary Resuscitation (CPR) and Advanced Cardiac Life Support (ACLS) measures were initiated. Record review revealed an Adult Resuscitation Documentation Form recorded by RN #3, which stated, "Date/Time Event Recognized: 05/13/2015 / 1950... Witnessed: No... Age: 62... Hospital-wide response activated: Yes... Illness Category: Medical Cardiac... Condition when need for compressions/defibrillation Identified: Pulseless... Circulation 1st Rhythm Requiring Compression: Asystole... Compression Manual... AED Applied Yes... 1954: No Spontaneous Breathing, No Spontaneous Pulse, Epinephrine (a medication administered to treat pulseless) 1 mg administered IV, Comments: CPR continued. 1957: No spontaneous Breathing, No Spontaneous Pulse, Epinephrine 1 mg administered IV, Comments: CPR continued. 1959: No Spontaneous Breathing, No Spontaneous Pulse, Comments: V-Fib. 2002: No Spontaneous Breathing, No Spontaneous Pulse, Epinephrine 1mg administered IV, Comments: Asystole. 2005: Breathing: Assisted, Ventilation: Endotracheal Tube (a tube inserted into the trachea to assist ventilations in a patient with inadequate respiratory effort), Intubation: Time 2005, Size 7 1/2, Confirmation: Auscultation, Exhaled CO2 (Carbon Dioxide)... Epinephrine 1mg administered IV, Comments: CPR continued. 2006: No Spontaneous Breathing, No Spontaneous Pulse, Epinephrine 1mg administered IV, Comments: CPR. 2007: 1 Amp Bicarb (Sodium Bicarbonate, a medication administered for acidosis) administered IV, Comments: CPR continued. 2009: Comments: Pulse Felt. 2011: Epinephrine 1mg administered IV, Comments: 102/79 (BP), 80 HR (Heart Rate). 2015: Epinephrine 1mg administered IV, Comments: Lost Pulse. CPR continued. 2018: Comments: Asystole. 2019: Comments: CPR stopped. Record review revealed CPR and ACLS measures to be unsuccessful, and Patient #1 expired on May 13, 2015 at 2019. Record review revealed a History and Physical written on 05/13/2015 at 2347, by MD #2, who documented, "The patient is a 62-year-old female, who had been admitted to the hospital for recurrent pneumonia and was dispositioned to Med-Surg after receiving blood cultures and 1 g (gram) of IV Vancomycin. On my initial assessment, she was noted to be unresponsive, and pulseless, for which a code blue was called. The patient underwent resuscitation per the ACLS guidelines. Initial rhythm was asystole. Following two cycles of ACLS protocol, her rhythm was noted to be ventricular fibrillation for which she received a single shock at 120 joules. Repeat rhythm thereafter noted asystole. CPR continued for an additional three cycles whereupon rhythm check she was noted to have a perfusing rhythm of sinus tachycardia and a palpable pulse. At this point, the patient had been successfully intubated. Her post resuscitative care following return of spontaneous circulation revealed a blood pressure of 100/79 with a heart rate of 80. At that point, normal saline had been started as bolus therapy. In the ongoing post resuscitative care, the patient was noted to become bradycardic, ultimately losing her pulse with the reinitiation of ACLS protocol. During this second round of ACLS protocol, each of the three rhythm checks revealed asystole. After 10 minutes of continued resuscitation efforts on the ACLS protocol, the code was called. Time of death 20:19. Proximate cause of death: Sepsis from healthcare associated left lobar pneumonia..."

Interview with CNA #1 conducted on June 25, 2015 at 0930 revealed that RN #1 was in the hospital room while the vital signs were obtained on May 13, 2015 at 1827, and was aware of the results.

Interview was conducted on June 25, 2015 at 0945 with RN #1, who stated she was aware of the hospital's Rapid Response Team policy, however on May 13, 2015 Patient #1 had been experiencing frequent confrontations with family members present in the hospital room, and experiencing great emotional upset since she had been admitted from the ER. Interview revealed she believed Patient #1's deteriorating vital signs were a result from that family dynamic, not a worsening of her medical condition. Interview revealed she did not feel the Rapid Response Team was warranted at that time. Interview revealed that noting the decreased Pulse Oximetry reading, increased Respiratory Rate, and decreasing level of consciousness, the Rapid Response Team should have been activated. Interview confirmed the hospital's policy for initiating the hospital's Rapid Response Team was not followed. Interview revealed the Bridge Admission Order Set is considered admission orders for nurses upon a patient's arrival to their room, and if "Monitoring: Cardiac Monitoring" is not checked, the patient is not placed on a cardiac monitor. Interview revealed there are no other orders for hospital floor staff to follow until a Hospitalist writes further admission orders. Interview revealed the Bridge Admission Order Set often arrives with the middle section of the page (which addresses monitoring, vital sign check frequency, IV therapy, and medications) blank. Interview revealed normally the Hospitalists request the floor nurses to call them when the patient is on the way to the hospital room, and under normal circumstances the Hospitalist and patient arrive to the hospital room almost simultaneously. Record review revealed no documentation on MD #2's notification status when Patient #1 was transported to hospital room 618 from the Emergency Department.

Interview was conducted on June 25, 2015 at 12:30, with the Emergency Department Medical Director, who stated the Bridge Admission Order Set, "is a means to get the patient physically admitted." Interview revealed the expectation for the Emergency Department Physician is to perform a verbal report to the accepting Hospitalist, who dictates the type of bed and monitoring status of an admitted patient. Interview revealed generally the middle section of the Bridge Admission Order Set is left blank, with the expectation that the accepting Hospitalist is going to see the admitted patient upon arrival to their assigned room. Interview revealed when the admitted patient leaves the Emergency Room, the patient is the responsibility of the accepting Hospitalist.

RN #2 was not available for interview, as RN #2 had resigned employment with the hospital.

MD #2 was not available for interview.

NURSING SERVICES

Tag No.: A0385

Based on review of hospital policy, closed medical record review, and staff interviews, the hospital's nursing staff failed to have an effective nursing service providing oversight to ensure registered nursing staff supervised and evaluated patient care.

The findings include:

1. The nursing staff failed to supervise and evaluate patient care by failing to respond to a change in a patient's respiratory status, resulting in cardiac arrest and subsequent death of 1 of 3 patients admitted from the Emergency Department (Patient #1).

~cross refer to 482.23(b)(3) Nursing Standard: Tag A0395

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on review of hospital policy, closed medical record review, and staff interviews, the nursing staff failed to supervise and evaluate patient care by failing to respond to a change in a patient's respiratory status, resulting in cardiac arrest and subsequent death of 1 of 3 patients admitted from the Emergency Department (Patient #1).

Findings include:

Review of the hospital's policy, "Rapid Response Team", revised 06/2012, revealed, "I. Purpose A. To quickly provide a multidisciplinary medical team approach (Respiratory Therapist, House Supervisor / Nurse Manager) to assess and treat a patient whose condition is deteriorating. In addition, the focus of this team shall be to provide support and education to staff as needed. B. To provide early and rapid intervention in order to promote better outcomes such as: reduced cardiac ad/or respiratory arrests in the hospital; reduced or more timely transfers to a higher level of care; reduced patient intubations; and reduced number of hospital deaths, etc... III. Definitions A. Rapid Response Team - A multidisciplinary team that responds to urgent patient situations throughout the hospital... IV. Policy A. The rapid response team shall be used for all areas outside Physician Services, Sleep Lab, ED (Emergency Department), OR (Operating Room) and PACU (Post Anesthesia Care Unit). This includes the Extended Care Unit. B. Adult Criteria for staff to call the Rapid Response Team is as follows... 4. Acute change in Respiratory Rate (less than 8 or greater than 28) or threatened airway 5. Acute change in oxygen saturation which reflects the percentage of red blood cells saturated with oxygen (level is less than 90% despite oxygen being utilized on the patient) 6. Acute change in Level of Consciousness..."

Review of the closed medical record of Patient #1 revealed a 62 year old female patient (Patient #1) who presented to the hospital's Dedicated Emergency Department (DED) with a chief complaint of chest pain, on May 13, 2015 at 1155. Record review revealed an initial Medical Screening Exam was performed by Medical Doctor (MD) #1, on May 13, 2015 at 1200. Review revealed initial vital signs of Blood Pressure (BP) 118/62 mmHg (millimeters of Mercury) (normal); Pulse 107 BPM (Beats Per Minute) (elevated); Respirations 18 RPM (Respirations Per Minute) (normal); Temperature 98.5 egress Fahrenheit (normal); Pulse Oximetry 90 % (percent) on room air (decreased); and mental status: alert and oriented (normal); were obtained by Emergency Medical Technician Paramedic (EMTP) #1 on May 13, 2015 at 1202. Review revealed treatment in the DED consisted of oxygen therapy, cardiac monitoring, 12 lead EKG (Electrocardiogram), Intravenous (IV) access, Albuterol and Atrovent (inhaled medications used to treat shortness of breath) Nebulizer Treatment, Lasix (a medication used to promote the excretion of excess fluid in Congestive Heart Failure) 40 mg (milligrams) IV administration, and Vancomycin (an antibiotic) 1000 mg IV infusion. Review revealed MD #1 consulted MD #2, a hospitalist, via telephone on May 13, 2015 at 1335, in reference to admitting Patient #1 for diagnosis of pneumonia (an infection of the lung) and hypoxemia (deficient oxygenation of the blood). Record review revealed vital signs of BP 123/56 mmHg (normal); Pulse 97 BPM (normal); Respirations 20 RPM (normal); Temperature 97.8 degrees Fahrenheit (normal); Pulse Oximetry 91 % on room air (decreased); and mental status: alert and oriented were obtained by EMTP #1 on May 13, 2015 at 1357. Review revealed Patient #1 was admitted to room 618 on May 13, 2015 at 1401. Record review revealed Patient #1 was assessed on May 13, 2015 at 1436 by Registered Nurse (RN) #1 who documented, "Pt (patient) transferred to med-surg (Medical-Surgical Unit) from ER (Emergency Room) and walked with steady gait to bed. Pt remains anxious and is currently sitting on side of the bed. O2 (Oxygen) 2 LPM (Liters Per Minute) via NC (Nasal Cannula) in place." Record review revealed RN #1 assessed Patient #1's cognitive status as alert and oriented on May 13, 2015 at 1515. Review revealed vital signs of BP 127/59 mmHg (normal); Pulse 129 BPM (elevated); Respirations 39 RPM (elevated); Temperature 96.1 degrees Fahrenheit (normal); and Pulse Oximetry 97 % (normal) on 3 LPM supplemental Oxygen via NC were obtained by Certified Nursing Assistant (CNA) #1 on May 13, 2015 at 1536. Record review revealed vital signs of BP 96/54 mmHg (decreased); Pulse 105 BPM (increased); Respirations 40 RPM (increased); Temperature 96.1 degrees Fahrenheit (normal); and Pulse Oximetry 88 % (decreased) on 3 LPM supplemental Oxygen via NC were obtained by CNA #1 on May 13, 2015 at 1827. Record review revealed a Nursing Note written by RN #2 on May 13, 2015 at 1930, "Assumed care of patient. Assessment completed. Pt very lethargic and resting at this time. Denied pain or discomfort. Watching TV (television). Will continue to monitor." Record review revealed no documentation that RN #2 reported a change in Patient #1's status to the attending physician. Record review revealed MD #2 entered Patient #1's room on May 13, 2015 at 1950 and found Patient #1 unresponsive and in cardiac arrest, at which time Cardiopulmonary Resuscitation (CPR) and Advanced Cardiac Life Support (ACLS) measures were initiated. Record review revealed an Adult Resuscitation Documentation Form recorded by RN #3, which stated, "Date/Time Event Recognized: 05/13/2015 / 1950... Witnessed: No... Age: 62... Hospital-wide response activated: Yes... Illness Category: Medical Cardiac... Condition when need for compressions/defibrillation Identified: Pulseless... Circulation 1st Rhythm Requiring Compression: Asystole... Compression Manual... AED Applied Yes... 1954: No Spontaneous Breathing, No Spontaneous Pulse, Epinephrine (a medication administered to treat pulseless) 1 mg administered IV, Comments: CPR continued. 1957: No spontaneous Breathing, No Spontaneous Pulse, Epinephrine 1 mg administered IV, Comments: CPR continued. 1959: No Spontaneous Breathing, No Spontaneous Pulse, Comments: V-Fib. 2002: No Spontaneous Breathing, No Spontaneous Pulse, Epinephrine 1mg administered IV, Comments: Asystole. 2005: Breathing: Assisted, Ventilation: Endotracheal Tube (a tube inserted into the trachea to assist ventilations in a patient with inadequate respiratory effort), Intubation: Time 2005, Size 7 1/2, Confirmation: Auscultation, Exhaled CO2 (Carbon Dioxide)... Epinephrine 1mg administered IV, Comments: CPR continued. 2006: No Spontaneous Breathing, No Spontaneous Pulse, Epinephrine 1mg administered IV, Comments: CPR. 2007: 1 Amp Bicarb (Sodium Bicarbonate, a medication administered for acidosis) administered IV, Comments: CPR continued. 2009: Comments: Pulse Felt. 2011: Epinephrine 1mg administered IV, Comments: 102/79 (BP), 80 HR (Heart Rate). 2015: Epinephrine 1mg administered IV, Comments: Lost Pulse. CPR continued. 2018: Comments: Asystole. 2019: Comments: CPR stopped. Record review revealed CPR and ACLS measures to be unsuccessful, and Patient #1 expired on May 13, 2015 at 2019. Record review revealed a History and Physical written on 05/13/2015 at 2347, by MD #2, who documented, "The patient is a 62-year-old female, who had been admitted to the hospital for recurrent pneumonia and was dispositioned to Med-Surg after receiving blood cultures and 1 g (gram) of IV Vancomycin. On my initial assessment, she was noted to be unresponsive, and pulseless, for which a code blue was called. The patient underwent resuscitation per the ACLS guidelines. Initial rhythm was asystole. Following two cycles of ACLS protocol, her rhythm was noted to be ventricular fibrillation for which she received a single shock at 120 joules. Repeat rhythm thereafter noted asystole. CPR continued for an additional three cycles whereupon rhythm check she was noted to have a perfusing rhythm of sinus tachycardia and a palpable pulse. At this point, the patient had been successfully intubated. Her post resuscitative care following return of spontaneous circulation revealed a blood pressure of 100/79 with a heart rate of 80. At that point, normal saline had been started as bolus therapy. In the ongoing post resuscitative care, the patient was noted to become bradycardic, ultimately losing her pulse with the reinitiation of ACLS protocol. During this second round of ACLS protocol, each of the three rhythm checks revealed asystole. After 10 minutes of continued resuscitation efforts on the ACLS protocol, the code was called. Time of death 20:19. Proximate cause of death: Sepsis from healthcare associated left lobar pneumonia..."

Interview with CNA #1 conducted on June 25, 2015 at 0930 revealed that RN #1 was in the hospital room while the vital signs were obtained on May 13, 2015 at 1827, and was aware of the results of Patient #1's vital signs.

Interview was conducted on June 25, 2015 at 0945 with RN #1, who stated she was aware of the hospital's Rapid Response Team policy, however on May 13, 2015 Patient #1 had been experiencing frequent confrontations with family members present in the hospital room, and experiencing great emotional upset since she had been admitted from the ER. Interview revealed she believed Patient #1's deteriorating vital signs were a result from that family dynamic, not a worsening of her medical condition. Interview revealed she did not feel the Rapid Response Team was warranted at that time. Interview revealed that noting the decreased Pulse Oximetry reading, increased Respiratory Rate, and decreasing level of consciousness, the Rapid Response Team should have been activated. Interview confirmed the hospital's policy for initiating the hospital's Rapid Response Team was not followed.

RN #2 was not available for interview, as RN #2 had resigned employment with the hospital.

MD #2 was not available for interview.

NC00106969