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Based on observation, interview and document review, the Governing Body did not promote patient rights for 1 of 30 sampled patient (1) by failing to provide care in a safe setting. Patient 1, who was on a ventilator (a machine used to breathe for a patient through a tube inserted into the lungs), experienced a ventilator tubing disconnection. Nursing and respiratory staff failed to respond to the ventilator alarm for 12 minutes, resulting in serious harm to the patient. In addition, the hospital failed to inform 3 of 30 sampled patients (16, 17, 3) and/or responsible party of their rights to formulate an advanced directive. The hospital failed to show documented evidence of informed consent for 3 of 30 sampled (3, 5, 13). The hospital failed to ensure that the Quality Assessment and Performance Improvement (QAPI) Program tracked and analyzed data regarding staff's response to ventilator and other patient alarms. There was no data on the response times of staff to patient alarms or a Performance Improvement plan for alarm response. The hospital's policy did not establish clear expectations of safety regarding response to ventilator and other patient alarms for all patients. The hospital's Governing Body also failed to ensure that the Root Cause Analysis (RCA - method of identifying event causes, revealing problems and solving them) performed by the hospital, following an adverse event, was thorough and credible in the identification of opportunities for improvement. The hospital did not ensure that the nursing service provided for adequate supervision of all patients by a Registered Nurse (RN). The hospital did not ensure that complete nursing care plans were developed, followed, and updated for all patients.


Findings:


1. The hospital failed to protect and promote each patient's rights by not informing patients of their rights related to formulating advance directives and the right to informed consent. The hospital failed to ensure that all care was provided in a safe setting. (A Tag 115)


2. The hospital failed to ensure that the QAPI program included monitoring of alarm response time for ventilated patients. The hospital also failed to ensure that the Root Cause Analysis performed by the hospital, following an adverse event, was thorough and credible in the identification of opportunities for improvement. In addition, part of the action plan developed did address the issue identified by the RCA. (A Tag 263)


3. The hospital did not ensure that nursing staff assessed and addressed the care needs of all patients. (A Tag 385)


4. The hospital failed to ensure that respiratory services were provided in a safe and effective manner and according to acceptable standards of practice. (A Tag 1151)


The cumulative effect of this systemic practice resulted in the failure of the hospital to be in compliance with the condition of participation for Governing Body.

Based on observation, interview, record and document review, the hospital did not promote each patient's rights when:


1. The hospital failed to ensure that care was provided in a safe setting for one patient when multiple staff members failed to respond to a ventilator alarm (an alarm on a breathing machine that is designed to alert staff to a possible medical emergency) for 12 minutes that resulted in an anoxic brain injury (injury to the brain due to a lack of oxygen). (A Tag 144)


2. There was no evidence that the hospital promoted the rights of multiple patients to formulate an Advance Directive (a legal document which communicates a person's preference for medical care). (A Tag 132 # 1, 2, 3)

3. The hospital failed to following their own policy and procedure related informed consent (a process by which the hospital ensures that a patient has adequate knowledge prior to consenting to treatment). (A Tag 131 #1, 2, 3)


4. Soft wrist restraints were applied without a valid physician's order or per the hospitals policy and procedure. (A Tag 168).


The cumulative effect of these systemic problems resulted in the hospitals failure to deliver care in compliance with the Condition of Participation for Patient Rights to ensure patient safety.

Based on observation, interview, record and document review, the hospital did not ensure that an effective Quality Assessment and Performance Improvement program (QAPI) was implemented when the hospital:


Performed a Root Cause Analysis ((RCA - method of identifying event causes, revealing problems and solving them) following Patient 1's ventilator alarms that went unanswered for 12 minutes, that was not thorough or credible in the identification of possible causes that may have contributed to an adverse event. The RCA did not identify that the assigned licensed nurse to Patient 1, on the day of the ventilator event, had the most number of high acuity (the measurement of the intensity of care required for a patient accomplished by a registered nurse) patients assigned to her. In addition, the action plan did not completely address the identified areas of improvement related to the adverse event. (A Tag 286 # 1, 2)


In addition, the hospital's Quality Assessment and Performance Improvement (QAPI) Program failed to track and analyze data regarding staff response to ventilator alarms. Ventilator care is a high-volume and high-risk area for this hospital. The hospital did not establish clear expectations of safety regarding response to ventilator and other patient alarms for all patients. (A Tag 286 # 3)


The cumulative effect of this systemic practice resulted in the failure of hospital to deliver statutorily mandated compliance with the condition of participation for Quality Assessment and Performance Improvement to ensure a safe environment to all patients.

Based on observation, interview, record and document review, the hospital did not ensure nursing staff assessed and addressed the care needs of the patients when:


1. Multiple nursing staff did not respond to a patient's mechanical ventilator (machine used to ensure proper lung oxygenation) alarms for 12 minutes, which resulted in an anoxic brain injury (injury to the brain due to a lack of oxygen). (A Tag 395)


2. Pain reassessment was not performed in accordance with the hospital's policy and procedure for one patient. (A Tag 396 # 1)


3. Multiple care plans were not updated to reflect the current status of multiple patients. (A Tag 396 # 1, 2, 3, 4)


The cumulative effect of these systemic problems resulted in the hospitals failure to deliver care in compliance with the Condition of Participation for Nursing Services to ensure that care needs were met.

Based on observation, interview, record and document review, the hospital failed to ensure that 1 of 30 sampled patients (1) received respiratory care services in accordance with acceptable standards of practice. A paging system, "Oxinet" (an electronic paging system designed to send alerts to staff via a beeper device), sent multiple alerts to Respiratory Therapist (RT) 1 that went unanswered for 12 minutes. As a result of these failures, Patient 1 sustained an anoxic brain injury (injury to the brain due to a lack of oxygen) with a poor prognosis, per the patient's attending physician.


Findings:



1. Patient 1 was admitted to the hospital on 2/11/14 with diagnoses that included hypercarbic respiratory failure (failure of the oxygenation and carbon dioxide elimination in the lungs), pulmonary hypertension (increased pressure in the pulmonary arteries) and right-sided congestive heart failure (the right side of the heart doesn't pump blood to the lungs normally), per the History and Physical (H&P), dated 2/11/14. Per the same document, Patient 1 required a ventilator (machine designed to move air in and out of the lungs). According to the "Patient Care Notes", dated 2/11/14 at 11:00 P.M., Patient 1 was assessed as alert and oriented x 3 (name, place and time).


On 5/7/14 at 1:45 P.M., an interview was conducted with the Director of Quality Management (DQM) and the Chief Clinical Officer (CCO). The DQM and the CCO both acknowledged that an internal investigation had been started and that the event involving Patient 1 was due to human error and not ventilator malfunction. The DQM and CCO stated that multiple pages were sent to RT 1 and those pages went unanswered.


On 5/7/14 at 2:35 P.M., an interview was conducted with RN 6. RN 6 acknowledged that she had cared for Patient 1 prior to the event and that Patient 1 was alert, able to communicate her needs by writing and was able to use the call light. In addition, she was able to move her hands, arms and was able to eat meals by mouth. RN 6 stated that staff were required to respond immediately to a ventilator alarm.


On 5/7/14 at 2:40 P.M., an interview was conducted with the Director of Respiratory Therapy (DRT). The DRT stated that if the oxygen saturation (O2 sat- the amount of oxygen in the blood) and heart rate (pulse) fell outside of the preset parameters for a patient, it would send a page alert to the RT assigned to that patient.


On 5/7/14 at 2:55 P.M., a joint observation of Patient 1 was conducted with RN 2. Patient 1 was transferred to the Intensive Care Unit (ICU) after the ventilator event. RN 2 stated that Patient 1 was non-responsive except to painful stimuli. Per RN 2, Patient 1 would open her eyes but did not track or follow (neurological assessment tool used to check brain function in an unresponsive patient). Patient 1 did not demonstrate any purposeful movement and she was not on any medications that would inhibit purposeful movements. RN 2 stated Patient 1 had been administered Dopamine (intravenous medication to treat low blood pressure) intermittently since the ventilator event to maintain adequate blood pressure.


On 5/7/14 at 3:30 P.M., a joint observation of the ventilator used by Patient 1, at the time of the event, was conducted with the DRT. The DRT stated that the expiratory limb (tubing from the patient to the machine that filters carbon dioxide) was disconnected from Patient 1 at the time of the event. Using the ventilator, the DRT demonstrated the ventilators settings and parameters that were set for Patient 1 at the time of the event. The DRT then disconnected the expiratory limb. The ventilator alarm was heard within 4-seconds of the disconnection, and continued to alarm until reconnected.


On 5/8/14 at 4:15 P.M., a joint review of the Oxinet report, dated 5/5/14, was conducted with the DQM. The report revealed that RT 1 received 23 pages for Patient 1 related to a high pulse rate and O2 saturation decline. The DQM stated that RT 3 was assigned to Patient 1 on the night of the ventilator event, but RT 3's Oxinet pager did not included Patient 1. Instead, Patient 1 was assigned to RT 1's Oxinet pager. Therefore, Patient 1's ventilator alert pages were sent to RT 1 instead of RT 3.


On 5/8/14 at 3:21 P.M., an interview was conducted with RN 5 (a resource nurse). RN 5 heard the rapid response call and went to Patient 1's room. RN 5 stated that RT 3 came a few seconds after her. RN 5 stated that RT 3 informed her, that she (RT 3) saw Patient 1's expiratory limb disconnected at the Y connector (a Y shape tube that attaches the inspiratory and expiratory limbs to the patient).


On 5/8/14 at 4:22 P.M., an interview was conducted with RT 1. RT 1 denied that Patient 1 was assigned to him on the night of the ventilator event. RT 1 stated that he received pages from the Oxinet system for his assigned patients, but denied receiving any pages for Patient 1. RT 1 also stated, "It didn't matter if I didn't get a page for Patient 1, the nurses get the pages too and they should have responded." RT 1 denied any assignment changes during his shift.


On 5/8/14 at 4:55 P.M., an interview was conducted with RT 3. RT 3 stated that she was assigned to Patient 1 due to Patient 1's preference for female caregivers. RT 3 stated LVN 1 called her cellular phone to inform her that Patient 1 requested to be suctioned. RT 3 stated that she asked LVN 1, "Why are you calling me for suction?" RT 3 stated that LVN 1 responded, "I am busy and the patient is desaturating". RT 3 stated she heard the rapid response called shortly after the call ended. RT 3 stated that she went to Patient 1's room and noticed the expiratory limb was disconnected. RT 3 denied that she had received any pages for Patient 1 on her shift.


On 5/13/14 at 3:51 P.M., an interview was conducted with the UC. The UC took over TT 4's responsibility and made the pager assignments on the night of the ventilator event. The UC stated she took over the telemetry and Oxinet system at 5:30 P.M. and had made the pager assignments for the RTs. The UC stated that she had assigned Patient 1 to RT 1's pager per the assignment sheet she received from the day shift RT lead.


The hospital's policy and procedure titled, "Ventilator Patient Management", revised on 3/13, indicated that, "All healthcare staff will respond to ventilator alarms to determine cause and notify Respiratory Care when needed". This policy was not implemented when nursing staff and RT staff did not respond to Patient 1's ventilator alarms for 12 minutes.


The hospital document titled "Plan for the Provision of Patient Care", under "Respiratory Care/Cardiopulmonary", indicated "The Respiratory Care department will provide the following therapeutic and diagnostic services to inpatients: Ventilator management. These services will be provided in accordance with standards of care, standards of practice."


Per the "Respiratory Care Practice Act, Business and Professions Code, Sections 3700", indicated "3702. Practice of respiratory care; Components; 'Respiratory care protocols' Respiratory care as a practice means a health care profession employed under the supervision of a medical director in the therapy, management, rehabilitation, diagnostic evaluation, and care of patients with deficiencies and abnormalities which affect the pulmonary system and associated aspects of cardiopulmonary and other systems functions, and includes all of the following: (a) Direct and indirect pulmonary care services that are safe, preventive, and restorative to the patient."


On 5/12/14 at 10:02 A.M., an interview with DQM and the CCO was conducted. The CCO stated that when RT 1 did not respond to the patient's ventilator alarm or Oxinet alert pages for Patient 1, it was not in accordance to the professional standard of care.

2. The hospital's policy and procedure did not establish clear expectations of safety regarding response time to ventilator and other patient alarms for all patients. (A Tag 1160 #1).

3. The hospital failed to ensure a written policy and procedure was developed to provide clear direction to staff when there was an assignment change. (A Tag 1160 #2)

The cumulative effect of this systemic practice resulted in the failure of the hospital to deliver statutorily mandated compliance with the condition of participation for Respiratory Services to ensure that safe care were provided to all patients.

Based on observation, interview, record and document review, the hospital failed to ensure that their own policy and procedure related to consent was implemented for 3 of 30 sampled patients (3, 5, 13). This failure could result in the probability that the patients were not fully informed of their care options.


Findings:


1. Patient 3 was admitted to the hospital on 7/10/13 with diagnosess that included progressive quadriplegia (unable to move, feel both arms and legs) per the History and Physical (H&P), dated 7/10/13.


On 5/12/14 at 3:35 P.M., an observation of Patient 3 was conducted. Patient 3 was observed in bed with multiple family members at bedside. Patient 3's daughter stated that he was his own responsible party. The patient was alert, oriented and verbally communicative.


On 5/14/14 at 1:46 P.M., a review of Patient 3's medical record was conducted. The document "Consent to Treat", dated 7/10/13 at 3:30 P.M., was observed to have a box marked, "Patient is unable to sign above because: LOC (level of consciousness)". The hospital's document titled "Admissions Agreement/Conditions of Treatment", dated 7/10/13 at 3:30 P.M., indicated that, "pt. unable to sign due to LOC".


On 5/14/14 at 2:20 P.M., an interview was conducted with Registered Nurse (RN) 7. RN 7 stated that Patient 3 was a forensic patient (term used for an incarcerated patient) in the past but was no longer. RN 7 stated that Patient 3 was his own responsible party.


The hospital's policy and procedure titled "Consent to Admission and Treatment", revised date 11/13, indicated, "1. Consent forms are signed upon the patient's admission to the hospital as part of the admissions procedure. 2. Consent of the patient is ordinarily obtained...However, when the patient physically unable or legally incompetent to consent and no emergency exits, then consent much be obtained from the legal guardian. 3. Telephone calls are permitted for consent, if necessary, and are conducted via conference with two witnessed on the line."


On 5/14/14 at 2:18 P.M., an interview was conducted with the Admission Manager (AM). The AM stated if the admission staff was unsuccessful in contacting the patient's responsible party to complete and sign the admission packet, including the consent to treatment, at the time of admission, the admission staff should communicate to nursing any follow-up needed to ensure that the necessary documents were completed.


2. Patient 5 was admitted to the hospital on 3/11/14 with diagnosis of respiratory failure (failure of the oxygenation and carbon dioxide elimination in the lungs), per the History and Physical (H&P), dated 3/11/14.


On 5/14/14 at 10:40 A.M., a review of Patient 5's medical record was conducted. The medical record review had revealed that the hospital document titled "Consent to Treat", dated 3/11/14 at 3:04 P.M., indicated, "2x attempts no Pt. or family contact". However, the hospital document titled "Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures", dated 5/8/14, revealed that Patient 5's husband was contacted via telephone for the consent authorization of the procedure, dated 5/8/14.


On 5/14/14 at 11:12 A.M., an interview with Registered Nurse Case Manager (RNCM) was conducted. RNCM reviewed Patient 5's "Consent to Treat" form and "Informed Consent to Surgery or Special Diagnostic or Therapeutic Procedures" form, and stated that if the patient's husband was available to consent for the procedure, then the admission department should have followed up to have the remaining consents signed by the patient's husband.


The hospitals policy and procedure titled "Consent to Admission and Treatment" revised date 11/13 indicated, "1. Consent forms are signed upon the patient's admission to the hospital as part of the admissions procedure. 2. Consent of the patient is ordinarily obtained...However, when the patient physically unable or legally incompetent to consent and no emergency exits, then consent much be obtained from the legal guardian. 3. Telephone calls are permitted for consent, if necessary, and are conducted via conference with two witnessed on the line."


On 5/14/14 at 2:18 P.M., an interview was conducted with the Admission Manager (AM). The AM stated if the admission staff was unsuccessful in contacting the patient's responsible party to complete and sign the admission packet, including the consent to treatment, at the time of admission, the admission staff should communicate to nursing any follow-up needed to ensure that the necessary documents were completed.


3. Patient 13 was admitted to the hospital on 5/9/14 with diagnosis of acute renal failure (abrupt loss of kidney function) per the History and Physical (H&P), dated 5/9/14.


On 5/13/14 at 9:00 A.M., a review of Patient 13's medical record was conducted. The medical record review had revealed that the hospital document titled "Consent to Treat", dated 5/9/14 at 1:36 P.M., indicated that, "Patient is unable to sign above because: medical condition."


On 5/13/14 at 11:05 A.M., an interview was conducted with the Admission Coordinator (AC). The AC stated that the department call log indicated that two attempts were made to contact Patient 13's responsible party, on 5/11/14 and 5/12/14, with no returned call. The AC stated that the process now was to document on the form "attempt made x2 with no contact" and that the licensed nurses were to be made aware that if family were seen on unit, to let the Admission Department know.


The hospitals policy and procedure titled "Consent to Admission and Treatment" revised date 11/13 indicated, "1. Consent forms are signed upon the patient's admission to the hospital as part of the admissions procedure. 2. Consent of the patient is ordinarily obtained...However, when the patient physically unable or legally incompetent to consent and no emergency exits, then consent much be obtained from the legal guardian. 3. Telephone calls are permitted for consent, if necessary, and are conducted via conference with two witnessed on the line."


On 5/14/14 at 2:18 P.M., an interview was conducted with the Admission Manager (AM). The AM stated if the admission staff was unsuccessful in contacting the patient's responsible party to complete and sign the admission packet, including the consent to treatment, at the time of admission, the admission staff should communicate to nursing any follow-up needed to ensure that the necessary documents were completed.

Based on observation, interview, and record review, the hospital failed to ensure that the patient and patient's responsible party's right to formulate an Advance Directive (a legal document which communicates a person's preference for medical care) was implemented for 3 of 30 sampled patients (16, 17, 3). The hospital's failure to provide the patient and patient's responsible party information regarding an Advance Directive did not allow the patient and responsible party to exercise their right to formulate an Advance Directive. In the absence of an Advance Directive, the patients' wishes concerning provision of care in certain situations were difficult to determine.


Findings:


1. A tour of the hospital's Medical/Surgical unit on 3 East was conducted on 5/12/14 at 2:39 P.M. Patient 16 was observed in bed with eyes closed.

A review of Patient 16's medical record was conducted on 5/12/14 at 3:20 P.M. The patient was admitted to the hospital on 4/10/14 with diagnoses that included respiratory failure (failure of the oxygenation and carbon dioxide elimination in the lungs) per the History and Physical, dated 4/11/14. Further review of the medical record showed no evidence of the patient's Advance Directive. The hospital document titled "Advance Directive and Patient Self-Determination" was blank except for a note indicating, "2 x attempt no family contact", and a signature by an admission staff.


An interview with registered nurse (RN) 16 was conducted on 5/12/14 at 3:30 P.M. RN 16 stated that Patient 16 was non-verbal and was not able to make decision on his own. RN 16 stated that the patient's wife was very involved with the patient's care. RN 16 also stated that they would call the patient's wife if they need to communicate anything regarding the patient's care. RN 16 stated that if the wife was not available, they would leave a message and the wife always called back.


An interview with the Admission Coordinator (AC) and Admission Staff (AS) 17 was conducted on 5/13/14 at 11:15 A.M. AS 17 stated that if the patient did not have the capacity to make decisions, the admission staff would attempt to contact the responsible party twice. AS 17 stated that after the second attempt, the admission department would place the admission packet, which included the Advance Directive questionnaire, in the patient's medical record. AS 17 stated that the nurses would follow-up any documents that needed signature from the responsible party. The AC stated that it was not the nurse's responsibility to follow-up missing signatures in the admission packet. However, the AC stated that the nurses would just do it anyway. Both the AC and AS 17 were not able to verbalize any formal method of communication, between the admission department and nursing, regarding following up documents that required signature from the patient's responsible party. Both the AC and AS 17 were not able to explain why the advance directive questionnaire for Patient 16 was left blank when the patient's wife, according to RN 16, was very involved with the patient's care and had been reachable by phone when needed.


A review of the hospital's policy and procedure titled "Advance Health Care Directives" indicated that, "A written advance health care directive is a document that may authorize another person to make health care decisions for a patient when the patient is no longer able to make decisions for him/herself. The advance directive may contain information about a patient's desires concerning the health care decisions, particularly decisions concerning end-of-life care." The policy also indicated that, "Every patient admitted to the hospital is given written information at the time of admission concerning the individual's right to make decisions regarding his/her medical care. This includes the right to accept or refuse treatment and the right to formulate advance directives." Per the same policy, "3. If the patient is incapacitated (unable to make decision) at the time of admission, (name of hospital) will give advance directive information to a family member or surrogate." This policy was not implemented when there was no documented evidence that further attempts were made to ensure that the patient's responsible party was given information regarding an Advance Directive.


An interview with the Admission Manager (AM) was conducted on 5/15/14 at 10:20 A.M. The AM stated if the admission staff was unsuccessful in contacting the patient's responsible party to complete and sign the admission packet and the Advance Directive questionnaire at the time of admission, the admission staff should communicate to nursing any follow-up needed to ensure that the necessary documents were completed. The AM acknowledged that follow-ups should have been done to ensure that Patient 16's right to formulate an Advance Directive was provided.


2. A tour of the hospital's Medical/Surgical unit on 3 East was conducted on 5/12/14 at 2:45 P.M. Patient 17 was observed awake in bed.


A review of Patient 17's medical record was conducted on 5/14/14 at 9:25 A.M. Patient 17 was admitted to the hospital on 4/29/14 with diagnoses that included lung infection per the History and Physical, dated 4/30/14. Further review of the medical record showed no evidence of the patient's Advance Directive. The hospital document titled "Advance Directive and Patient Self-Determination" was blank except for a note indicating, "x 2 attempts to contact family, no response" and a signature by an admission staff.


A joint record review and interview with licensed vocational nurse (LVN) 16 was conducted on 5/14/14 at 9:25 A.M. LVN 16 stated that Patient 17 was alert and oriented to name, place and time. LVN 16 stated that the patient was able to make decisions on her own. LVN 16 acknowledged that the Advance Directive questionnaire was left blank. LVN 16 stated that the Advance Directive questionnaire should have been discussed with the patient because the patient was alert and oriented.


A review of the hospital's policy and procedure titled "Advance Health Care Directives" indicated that, "A written advance health care directive is a document that may authorize another person to make health care decisions for a patient when the patient is no longer able to make decisions for him/herself. The advance directive may contain information about a patient's desires concerning the health care decisions, particularly decisions concerning end-of-life care." The policy also indicated that, "Every patient admitted to the hospital is given written information at the time of admission concerning the individual's right to make decisions regarding his/her medical care. This includes the right to accept or refuse treatment and the right to formulate advance directives." Per the same policy, "1. This written information concerning the individual's right to make decisions regarding his/her medical care, including the right to accept or refuse treatment and the right to formulate advance directives is given to the patient at the time of each admission. 2. Documentation in the medical record will note whether or not the patient has executed an advance directive. Provision of care is not based on whether or not an advance directive has been executed." This policy was not implemented when there was no documented evidence that Patient 17 was given information regarding an Advance Directive.


An interview with the Admission Manager (AM) was conducted on 5/15/14 at 10:20 A.M. The AM stated if the admission staff was not able to communicate with the patient to complete and sign the admission packet and the Advance Directive questionnaire at the time of admission, the admission staff should communicate to nursing any follow-up needed to ensure that the necessary documents were completed. The AM acknowledged that follow-ups should have been done to ensure that Patient 17's right to formulate an Advance Directive was provided.








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3. Patient 3 was admitted to the hospital on 7/10/13 with diagnoses that included progressive quadriplegia (unable to move, feel both arms and legs) per the History and Physical (H&P), dated 7/10/13.


On 5/12/14 at 3:35 P.M., an observation of Patient 3 was conducted. Patient 3 was observed in bed with multiple family members at bedside. Patient 3's daughter stated that he was his own responsible party. The patient was alert, oriented and verbally communicative.


On 5/14/14 at 1:46 P.M., a review of Patient 3's medical record was conducted. There was no evidence that Patient 3 had an Advance Directive. Further review of the medical record revealed that the hospital document titled "Advance Directive and Patient Self-Determination", dated 7/10/13 at 3:32 P.M. for Patient 3, indicated that, "Pt. (patient) is incarcerated, unable to sign due to LOC (level of consciousness)".


On 5/14/14 at 2:20 P.M., an interview was conducted with Registered Nurse (RN) 7. RN 7 had acknowledged that Patient 3 was a forensic patient (term used for an incarcerated patient) in the past but was no longer. RN 7 stated that Patient 3 was his own responsible party.


An interview with the Admission Manager (AM) was conducted on 5/15/14 at 10:20 A.M. The AM stated if the admission staff was unsuccessful in contacting the patient's responsible party to complete and sign the admission packet and the Advance Directive questionnaire at the time of admission, the admission staff should communicate to nursing any follow-up needed to ensure that the necessary documents were completed. The AM acknowledged that follow-ups should have been done to ensure that Patient 3's right to formulate an Advance Directive was provided.


A review of the hospital's policy and procedure titled "Advance Health Care Directives" indicated that, "A written advance health care directive is a document that may authorize another person to make health care decisions for a patient when the patient is no longer able to make decisions for him/herself. The advance directive may contain information about a patient's desires concerning the health care decisions, particularly decisions concerning end-of-life care." The policy also indicated that, "Every patient admitted to the hospital is given written information at the time of admission concerning the individual's right to make decisions regarding his/her medical care. This includes the right to accept or refuse treatment and the right to formulate advance directives." Per the same policy, "3. If the patient is incapacitated (unable to make decision) at the time of admission, (name of hospital) will give advance directive information to a family member or surrogate." This policy was not implemented when there was no documented evidence that further attempts were made to ensure that the patient's responsible party was given information regarding an Advance Directive.

Based on observation, interview, record and document review, the hospital failed to ensure that 1 of 30 sampled patients (1) received care in a safe setting. Multiple staff members failed to respond to a ventilator alarm (an alarm on a breathing machine that is designed to alert staff to a possible medical emergency) for 12 minutes. In addition, a paging system, "Oxinet", (an electronic paging system designed to send alerts to staff via a beeper device), sent multiple alerts to Respiratory Therapist (RT) 1 and Licensed Vocational Nurse (LVN) 1, that went unanswered. As a result of these failures, Patient 1 sustained an anoxic brain injury (injury to the brain due to a lack of oxygen) with a poor prognosis, per the patient's attending physician.


Findings:


Patient 1 was admitted to the hospital on 2/11/14 with diagnoses that included hypercarbic respiratory failure (failure of the oxygenation and carbon dioxide elimination in the lungs), pulmonary hypertension (increased pressure in the pulmonary arteries) and right-sided congestive heart failure (the right side of the heart doesn't pump blood to the lungs normally), per the History and Physical (H&P), dated 2/11/14. Per the same document, Patient 1 required a ventilator (machine designed to move air in and out of the lungs). According to the "Patient Care Notes", dated 2/11/14 at 11:00 P.M., Patient 1 was assessed as alert and oriented x 3 (name, place and time).


On 5/7/14 at 1:45 P.M., an interview was conducted with the Director of Quality Management (DQM) and the Chief Clinical Officer (CCO). The DQM and the CCO both acknowledged that an internal investigation had been started and that the event involving Patient 1 was due to human error and not ventilator malfunction. The DQM and CCO stated that two Registered Nurses (RN), one of whom was the Charge Nurse (RN 3), were at the nursing station and heard the alarm, but did not respond. In addition, multiple pages were sent to RT 1 and LVN 1, and those pages went unanswered.

On 5/7/14 at 2:25 P.M., an observation was conducted of the room that Patient 1 was in at the time of the ventilator event. Patient 1's room was located on the medical/surgical floor and was located 13' from the nurses station per the measurement of the hospital maintenance staff. An external alarm box was located on the wall outside the door of Patient 1's room. The external alarm was tested, and delivered a loud beeping sound and flashing red light when activated. The alarm was audible and visible from the nursing station.


On 5/7/14 at 2:35 P.M., an interview was conducted with RN 6. RN 6 acknowledged that she had cared for Patient 1 prior to the event and that Patient 1 was alert, able to communicate her needs by writing and was able to use the call light. In addition, she was able to move her hands, arms and was able to eat meals by mouth. RN 6 stated that staff were required to respond immediately to a ventilator alarm.


On 5/7/14 at 2:40 P.M., an interview was conducted with the Director of Respiratory Therapy (DRT). The DRT stated that if a patient's oxygen saturation (O2 sat- the amount of oxygen in the blood) and heart rate (pulse) fell outside of a ventilator's preset parameters for that patient, a page alert, via a beeper device, would be sent to the RT and nursing staff assigned to that patient.


On 5/7/14 at 2:55 P.M., a joint observation of Patient 1 was conducted with RN 2. Patient 1 was transferred to the Intensive Care Unit (ICU) after the ventilator event. RN 2 stated that Patient 1 was non-responsive except to painful stimuli. Per RN 2, Patient 1 would open her eyes but did not track or follow (neurological assessment tool used to check brain function in an unresponsive patient). Patient 1 did not demonstrate any purposeful movement and she was not on any medications that would inhibit purposeful movements. RN 2 stated Patient 1 had been administered Dopamine (intravenous medication to treat low blood pressure) intermittently since the ventilator event to maintain adequate blood pressure.


On 5/7/14 at 3:30 P.M., a joint observation of the ventilator used by Patient 1, at the time of the event, was conducted with the DRT. The DRT stated that the expiratory limb (tubing from the patient to the machine that filters carbon dioxide) was disconnected from Patient 1 at the time of the event. Using the ventilator, the DRT demonstrated the ventilator's settings with parameters that were set for Patient 1 at the time of the event. The DRT then disconnected the expiratory limb. The ventilator alarm was heard within 4-seconds of the disconnection, and continued to alarm until reconnected.


On 5/8/14 at 4:15 P.M., a joint review of the Oxinet report, dated 5/5/14, was conducted with the DQM. Per the report, alerts concerning Patient 1's ventilator were sent via the Oxinet paging system, beginning at 3:22 A.M. and continuing through 3:30 A.M. The report revealed that RT 1 received 23 pages via the beeper device for Patient 1 related to a high pulse rate and O2 saturation decline. Per the same report, LVN 1 received 24 beeper pages for Patient 1. However, the DQM stated that RT 3 was assigned to Patient 1 on the night of the ventilator event, but RT 3's Oxinet pager did not include Patient 1. Instead, Patient 1 was assigned to RT 1's Oxinet pager. Therefore, Patient 1's ventilator alert pages were sent to RT 1 instead of RT 3.


On 5/8/14 at 12:51 P.M., an interview was conducted with RN 1. RN 1 was partnered with LVN 1 on the night of the ventilator event. Both RN 1 and LVN 1 were responsible for Patient 1's care. The LVN's scope of practice limited LVN 1's ability to perform certain duties to care for Patient 1. Therefore, RN 1, being the Registered Nurse, had ultimate responsibility for Patient 1's care. RN 1 stated she was at the nursing station and heard Patient 1's ventilator alarming. RN 1 stated, "It was just the vent alarm, it's not like the oxygen saturation alarm, so I didn't think anything of it". RN 1 stated that LVN 1 was seen going into Patient 1's room and then came out and called RN 1 for help. RN 1 went into Patient 1's room and found the patient unresponsive.


On 5/8/14 at 1:20 P.M., an interview was conducted with RN 3 (the Charge Nurse on the night of the ventilator event). RN 3 stated that she was at the nursing station from 2:45 A.M. through 3:30 A.M. She acknowledged that she heard "multiple" alarms sounding during this time period. RN 3 acknowledged that she did not respond to those alarms, as she was receiving a nursing report. In addition, she stated she saw LVN 1 enter the patient's room at some point. RN 3 stated that the telemetry technician (TT) 2 called the nursing station (unsure of time) and informed her that Patient 1 was "desaturating" (oxygen level in blood drops). Immediately following the phone call from TT 2, RN 3 heard LVN 1 come out of Patient 1's room and yell, "I need help, call rapid response (a process when a team of licensed staff responds to a medical emergency)." RN 3 called the Rapid Reponse Team.


On 5/8/14 at 2:00 P.M., an interview was conducted with LVN 1. LVN 1 was assigned to Patient 1. LVN 1 stated that the last page she received for Patient 1 was at 3:11 A.M., while providing care and repositioning the patient. LVN 1 denied receiving any other pages for Patient 1 after 3:11 A.M. LVN 1 stated, at some point during her shift (was unable to provide the exact time), RN 3 told her that Patient 1 was desaturating so she went into Patient 1's room and found Patient 1 unresponsive and cyanotic (bluish discoloration of the skin from a lack of oxygen). LVN 1 stated that she yelled to call a rapid response.


On 5/8/14 at 3:21 P.M., an interview was conducted with RN 5 (a resource nurse who provided breaks). RN 5 heard the rapid response called and went to Patient 1's room. RN 5 stated that RT 3 arrived a few seconds after her. RT 3 informed RN 5 that Patient 1's expiratory limb was disconnected at the Y connector (a Y shape tube that attaches the inspiratory and expiratory limbs to the patient).


On 5/8/14 at 2:53 P.M., an interview was conducted with TT 2. TT 2 was assigned to the Oxinet system on the night of the event. TT 2 stated that at approximately 3:00 A.M., the Oxinet paging system was alarming for Patient 1 due to high pulse rate. TT2 stated that she called the nursing station, but no one answered. TT 2 stated she called the nurses station a second time. She could not recall the time between calls. TT 2 stated that RN 1 answered the phone on the second call, and that RN 1 was informed of Patient 1's Oxinet high pulse rate alarm. TT 2 stated that when Patient 1's oxygen saturation started to drop, she called the nurses station a third time. TT 2 stated that RN 3 answered the phone and she informed RN 3 of Patient 1's Oxinet alert due to the patient's drop in oxygen saturation.


On 5/8/14 at 4:22 P.M., an interview was conducted with RT 1. RT 1 denied that Patient 1 was assigned to him on the night of the ventilator event. RT 1 stated that he received pages from the Oxinet system for his assigned patients, but denied receiving any pages for Patient 1. RT 1 also stated, "It didn't matter if I didn't get a page for Patient 1, the nurses get the pages too and they should have responded." RT 1 denied any assignment changes during his shift.


On 5/8/14 at 4:55 P.M., an interview was conducted with RT 3. RT 3 stated that she was assigned to Patient 1 due to Patient 1's preference for female caregivers. RT 3 stated LVN 1 called her cellular phone to inform her that Patient 1 requested to be suctioned. RT 3 stated that she asked LVN 1, "Why are you calling me for suction?" RT 3 stated that LVN 1 responded, "I am busy and the patient is desaturating". RT 3 stated she heard the rapid response called shortly after the call ended. RT 3 stated that she went to Patient 1's room and noticed the expiratory limb was disconnected. RT 3 denied that she had received any pages for Patient 1 on her shift. This was consistent with the Oxinet report which revealed that pages were sent to RT 1.


On 5/13/14 at 3:51 P.M., an interview was conducted with the Unit Clerk (UC). The UC took over TT 4's responsibility and made the pager assignments on the night of the ventilator event. The UC stated she took over the telemetry and Oxinet system at 5:30 P.M. and had made the pager assignments for the RNs, LVNs, and RTs. The UC stated that she had assigned Patient 1 to RT 1's pager per the assignment sheet she received from the day shift RT lead.


The hospital's policy and procedure titled, "Ventilator Patient Management", revised on 3/13, indicated that, "All healthcare staff will respond to ventilator alarms to determine cause and notify Respiratory Care when needed". This policy was not implemented when nursing staff and RT staff did not respond to Patient 1's ventilator alarms for 12 minutes.


The hospital document titled "Plan for the Provision of Patient Care", under "Respiratory Care/Cardiopulmonary", indicated "The Respiratory Care department will provide the following therapeutic and diagnostic services to inpatients: Ventilator management. These services will be provided in accordance with standards of care, standards of practice."


Per the "Respiratory Care Practice Act, Business and Professions Code, Sections 3700", indicated "3702. Practice of respiratory care; Components; 'Respiratory care protocols' Respiratory care as a practice means a health care profession employed under the supervision of a medical director in the therapy, management, rehabilitation, diagnostic evaluation, and care of patients with deficiencies and abnormalities which affect the pulmonary system and associated aspects of cardiopulmonary and other systems functions, and includes all of the following: (a) Direct and indirect pulmonary care services that are safe, preventive, and restorative to the patient."


On 5/12/14 at 10:02 A.M., an interview with DQM and the CCO was conducted. The CCO stated that the process of informing the tele techs of any reassignments for RTs and licensed nurses was not a written policy but was the expected practice. The CCO stated that when RT 1 did not respond to the alert pages for Patient 1, it was not the professional standard of care. Both the DQM and CCO acknowledged that Patient 1 was not provided care in a safe setting when RT 1 and nursing staff did not respond to the patient's ventilator alarm or Oxinet pages.

Based on observation, interview, record and document review, the hospital failed to follow their own policy and procedure related to restraints for 1 of 30 sampled patients (13). As a result, nurses applied bilateral (both) wrist restraints to Patient 13 without the authorization from the patient's physician.


Findings:


On 5/13/14 at 9:00 A.M., a review of Patient 13's medical record was conducted. Patient 13 was admitted to the hospital on 5/9/14 with diagnoses that included acute renal failure (abrupt loss of kidney function) per the History and Physical (H&P), dated 5/9/14.


A review of the Physician Order for Medical Restraint, dated 5/12/14 at 8:45 A.M., was conducted on 5/13/14 at 9:15 A.M. The document's instruction located on the bottom of the form indicated, "I have performed a face to face (re) assessment of the patient and the patient requires restraint". Further review of the document indicated that the physician's order to renew the use of bilateral wrist restraints was given via telephone. The area requiring for the physician's signature was left blank.


On 5/13/14 at 1:51 P.M., a joint interview and observation of Patient 13 was conducted with Registered Nurse (RN) 8. Patient 13 was observed in his bed with soft wrist restraints applied to both of the patient's wrists. RN 8 stated that restraint orders should be renewed every 24 hours. RN 8 stated that Patient 13 had behaviors of agitation and episodes of pulling his central line (a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood over a long period of time) and the tubing from the mechanical ventilator (machine designed to move air in and out of the lungs).


The hospital's policy and procedure titled "Restraint Use", approval date of 9/13, was reviewed on 5/13/14 at 6:15 P.M. The policy indicated that, "4) Telephone Orders....b) A telephone order for restraint is only accepted for the initial application (once)." The policy also indicated, "A face-to-face assessment of the patient by the attending physician is documented daily following initiation of restraint and before renewal of restraint orders." This policy was not implemented when Patient 1's wrist restraint renewal order, dated 5/12/14, was given via a telephone order. In addition, there was no evidence that a face to face assessment of the patient was performed.


On 5/13/14 at 6:30 P.M., an interview was conducted with the Chief Clinical Officer (CCO) and the Director of Quality Management (DQM). The CCO and the DQM both stated that Patient 13's restraint order, dated 5/12/14, was not a valid order and was not in accordance with the hospital's policy and procedure.

Based on interview, record and document review, the hospital failed to ensure that the Root Cause Analysis (RCA - method of identifying event causes, revealing problems and solving them) performed by the hospital following an adverse event, was thorough and credible in the identification of opportunities for improvement related to the nurse assignments/patient acuity (the measurement of the intensity of care required for a patient accomplished by a registered nurse) on the night the adverse event occurred. In addition, the action plans developed in response to the adverse event, did not directly address the issue identified by the hospital related to, the hospital's Oxinet pager (an electronic paging system designed to send alerts to staff via a beeper device) assignment process. By not conducting a thorough and credible root cause analysis, the hospital was unable to identify possible causes that may have contributed to Patient 1's ventilator alarm not being answered for 12 minutes, resulting in anoxic brain injury (injury to the brain due to a lack of oxygen). In addition, by not developing an action plan that directly address the issue, the hospital would not be able to prevent the issue from reoccurring in the future.


Furthermore, the hospital's Quality Assessment and Performance Improvement (QAPI) Program failed to track and analyze data regarding staff response to ventilator alarms. Ventilator care is a high-volume and high-risk area for this hospital. The hospital did not establish clear expectations of safety regarding response to ventilator and other patient alarms for all patients.


Findings:


1. An interview with the Chief Clinical Officer (CCO) and the Director of Quality Management (DQM) was conducted on 5/14/14 at 10:02 A.M. Both the CCO and DQM were asked what were the areas of improvement identified by the RCA related to the adverse event. The CCO and DQM did not mention that the RCA identified any issues related to nurse staffing/ patient acuity.


On 5/15/14 at 10:00 A.M., the nurse assignment sheet for the night shift, dated 5/3/14 (the date of the event) was reviewed. According to the assignment sheet, Licensed Vocational Nurse (LVN) 1, the nurse assigned to Patient 1, was assigned four patients. Per the assignment sheet, 3 of the 4 patients assigned to LVN 1 had high acuity level of care.

On 5/15/14 at 10:35 A.M., a joint document review and interview was conducted with Nurse Supervisor (NS) 1 and the CCO. NS 1 stated that patient acuity scores were assessed and assigned by the Registered Nurses based on needs of the patient. Once the acuity was done, the Nurse Supervisor will use the acuity numbers to balance out the nurse assignments. The CCO reviewed the assignment sheet, dated 5/3/14 for night shift and could not explain why LVN 1 was assigned three patients with high acuity.


On 5/15/14 at 11:40 A.M., a joint document review and interview was conducted with Nurse Supervisor (NS) 2 and the CCO. NS 2 stated that he completed the assignment sheet for the night shift on 5/3/14. When asked about LVN 1's assignment and whether the assignment was distributed equitably, NS 2 answered, "No. In retrospect I would have given one of the high acuity patients to (name of RN 1)", who was not assigned any high acuity patients.


The hospital's policy and procedure titled "Staffing-Patient Assignment", revised date 4/11, indicated that, "1. The patient assignment is prepared by the Nursing Supervisor, or designee, prior to the commencement of the shift, utilizing the following guidelines: e. Staff-patient ratio and equity of workload".


On 5/15/14 at 1:10 P.M., an interview was conducted with the Quality Assurance and Performance Improvement Committee (QAPI). The DQM stated that one of the purpose of the RCA was the immediate identification of causative factors that contributed to the event and to formulate action plans. The QAPI committee was not aware that LVN 1's assignment had three high acuity patients on the night of the event.


A review of the hospital's "Risk Management Plan", revised on 3/14, indicated that, "The goals of a RCA is as follows:
-attempt to delineate the specific sequence of events and the departments, services, and personal involved.
-uncover the special causes of events
-define the variance in process, why the error might have occurred, and what systems and processes may have contributed.
-identify systematic improvements needed to reduce risk
-identify and allocate resources for staff members involved with sentinel event."


This Risk Management Plan was not followed when the RCA did not identify that LVN 1 was assigned three high acuity patients on the night of the event. The nurse staffing/patient acuity on the night of the event was not identified by the RCA, during their investigation of the adverse event, as an area for improvement.


2. An interview with the Chief Clinical Officer (CCO) and the Director of Quality Management (DQM) was conducted on 5/14/14 at 10:02 A.M. Both the CCO and the DQM stated that one of the areas of improvement the Root Cause Analysis (RCA - method of identifying event causes, revealing problems and solving them) identified, as a result of the adverse event, was the hospital's Oxinet pager assignment process. The DQM stated that on the night of the ventilator event, Patient 1 was originally assigned to Respiratory Therapist (RT) 1 and was reassigned to RT 3. However, the DQM stated that the reassignment of Patient 1 was not communicated to the telemetry technician (tele tech), who was responsible in programming the pagers. The Oxinet pagers were programmed to ensure that the assigned RTs and nurses were notified when the patients' preset ventilator parameters went out of range.


On 5/12/14 at 2:55 P.M., an interview was conducted with RT 4. RT 4 was asked what he would do if his patient assignment was changed in the middle of his shift. RT 4 was not able to verbalize the process of notifying the tele tech to ensure that the Oxinet pagers were reassigned to the correct RT.


On 5/12/14 at 3:00 P.M., a surveyor interviewed RT 16. RT 16 was also asked what she would do if her patient assignment was changed in the middle of her shift. RT 16 was not able to verbalize the process of notifying the tele tech to ensure that the Oxinet pagers were reassigned to the correct RT.


On 5/13/14 at 9:17 A.M., an interview was conducted with RT 5. RT 5 was asked what she would do if her patient assignment was changed in the middle of her shift. RT 5 was not able to verbalize the process of notifying the tele tech to ensure that the Oxinet pagers were reassigned to the correct RT.


On 5/14/14 at 7:50 A.M., a joint document review and interview was conducted with the DQM. The hospital's document titled "Simulator Room Training Agenda", dated May 2014, and the staff training attestations were reviewed with the DQM. The training agenda indicated that the training provided to the staff, related to the Oxinet pagers, only addressed, "what to do if you receive pages for a patient you are not assigned to". In addition, a review of the training attestation indicated, "#2 If I receive a page on my pager regarding a patient not assigned to me on my workload, I will..." The staff training provided in response to the adverse event did not include notifying the tele tech when patient reassignment occurred anytime during a shift. The DQM acknowledged that the action plans developed, did not address the specific issue identified related to the Oxinet pager assignment process.


On 5/15/14 at 1:10 P.M., an interview was conducted with the Quality Assurance and Performance Improvement Committee (QAPI). The DQM stated that one of the purposes of the RCA was the immediately identify the causative factors that contributed to the adverse event and to formulate action plans.


A review of the hospital's "Risk Management Plan", revised on 3/14, indicated that, "The goals of a RCA is as follows:
-attempt to delineate the specific sequence of events and the departments, services, and personal involved.
-uncover the special causes of events
-define the variance in process, why the error might have occurred, and what systems and processes may have contributed.
-identify systematic improvements needed to reduce risk
-identify and allocate resources for staff members involved with sentinel event."


The Risk Management Plan was not followed when, the action plans developed in response to the adverse event did not address the issue related to the notification of the tele tech when an assignment change occurred, to ensure that the Oxinet pagers where reassigned. The RCA identified that one of the issues that contributed to the adverse event was the failure of RT staff to notify the tele tech of an assignment change. However, the training of staff, which was part of the hospital's action plan, did not address the issues related to the notification of the tele tech during an assignment change.


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3. The hospital's Performance Improvement Plan 2014 was reviewed on 5/15/14 at 1:00 P.M. The plan indicated that, the respiratory department tracked "ventilator weaning (a gradual withdrawal of ventilator support) rate, missed treatments, and patients on oxygen with physician's order". Per the same document, these areas were considered "high volume" and "problem prone". There was no documented evidence of data collected related to staff response to ventilator alarms.


On 5/15/14 at 1:10 P.M., an interview was conducted with the Quality Assurance and Performance Improvement Committee (QAPI). The Director of Respiratory Therapy (DRT) was asked about data collected regarding ventilators other than what was indicated in the hospital's Performance Improvement Plan 2014. The DRT stated that there was no other formal data gathered related to ventilators.

Based on observation, interview, record and document review, the hospital failed to ensure that a Registered Nurse (RN) evaluated and assessed the care needs for 1 of 30 sampled patients (1). Multiple nursing staff failed to respond for 12 minutes to a ventilator alarm (an alarm on a breathing machine that is designed to alert staff to a possible medical emergency). In addition, a paging system,"Oxinet" (an electronic paging system designed to send alerts to staff via a beeper device), sent multiple alerts to Licensed Vocational Nurse (LVN) 1, that went unanswered. As a result of these failures, Patient 1 sustained an anoxic brain injury (injury to the brain due to a lack of oxygen) with a poor prognosis, per the patient's attending physician.


Findings:


Patient 1 was admitted to the hospital on 2/11/14 with diagnoses that included hypercarbic respiratory failure (failure of the oxygenation and carbon dioxide elimination in the lungs), pulmonary hypertension (increased pressure in the pulmonary arteries) and right-sided congestive heart failure (the right side of the heart doesn't pump blood to the lungs normally), per the History and Physical (H&P), dated 2/11/14. Per the same document, Patient 1 required a ventilator (machine designed to move air in and out of the lungs). According to the "Patient Care Notes", dated 2/11/14 at 11:00 P.M., Patient 1 was assessed as alert and oriented x 3 (name, place and time).


On 5/7/14 at 1:45 P.M., an interview was conducted with the Director of Quality Management (DQM) and the Chief Clinical Officer (CCO). The DQM and the CCO both acknowledged that an internal investigation had been started and that the event involving Patient 1 was due to human error and not ventilator malfunction. The DQM and CCO stated that two Registered Nurses (RN), one of whom was the Charge Nurse (RN 3), were at the nursing station and heard the alarm, but did not respond. In addition, multiple pages were sent to LVN 1, and those pages went unanswered.

On 5/7/14 at 2:25 P.M., an observation was conducted of the room that Patient 1 was in at the time of the ventilator event. Patient 1's room was located on the medical/surgical floor and was located 13' from the nurses station per the measurement of the hospital maintenance staff. An external alarm box was located on the wall outside the door of Patient 1's room. The external alarm was tested, and delivered a loud beeping sound and flashing red light when activated. The alarm was audible and visible from the nursing station.


On 5/7/14 at 2:35 P.M., an interview was conducted with RN 6. RN 6 acknowledged that she had cared for Patient 1 prior to the event and that Patient 1 was alert, able to communicate her needs by writing and was able to use the call light. In addition, she was able to move her hands, arms and was able to eat meals by mouth. RN 6 stated that staff were required to respond immediately to a ventilator alarm.


On 5/7/14 at 2:40 P.M., an interview was conducted with the Director of Respiratory Therapy (DRT). The DRT stated that if the oxygen saturation (O2 sat- the amount of oxygen in the blood) and heart rate (pulse) fell outside of the preset parameters for a patient, it would send a page alert to the RT and nursing staff assigned to that patient.


On 5/7/14 at 2:55 P.M., a joint observation of Patient 1 was conducted with RN 2. Patient 1 was transferred to the Intensive Care Unit (ICU) after the ventilator event. RN 2 stated that Patient 1 was non-responsive except to painful stimuli. Per RN 2, Patient 1 would open her eyes but did not track or follow (neurological assessment tool used to check brain function in an unresponsive patient). Patient 1 did not demonstrate any purposeful movement and she was not on any medications that would inhibit purposeful movements. RN 2 stated Patient 1 had been administered Dopamine (intravenous medication to treat low blood pressure) intermittently since the ventilator event to maintain adequate blood pressure.


On 5/7/14 at 3:30 P.M., a joint observation of the ventilator used by Patient 1, at the time of the event, was conducted with the DRT. The DRT stated that the expiratory limb (tubing from the patient to the machine that filters carbon dioxide) was disconnected from Patient 1 at the time of the event. Using the ventilator, the DRT demonstrated the ventilators settings and parameters that were set for Patient 1 at the time of the ventilator event. The DRT then disconnected the expiratory limb. The ventilator alarm was heard within 4-seconds of the disconnection, and continued to alarm until reconnected.

On 5/8/14 at 4:15 P.M., a joint review of the Oxinet report, dated 5/5/14, was conducted with the DQM. Per the report, alerts concerning Patient 1's ventilator were sent via the Oxinet paging system, beginning at 3:22 A.M. and continuing through 3:30 A.M. The report revealed that LVN 1 received 24 pages for Patient 1 related to a high pulse rate and O2 saturation decline.


On 5/8/14 at 12:51 P.M., an interview was conducted with RN 1. RN 1 was partnered with LVN 1 on the night of the ventilator event. Both RN 1 and LVN 1 were responsible for Patient 1's care. The LVN's scope of practice limited LVN 1's ability to perform certain duties to care for Patient 1. Therefore, RN 1, being the Registered Nurse, had ultimate responsibility for Patient 1's over all care. RN 1 stated she was at the nursing station and heard Patient 1's ventilator alarming. RN 1 stated, "It was just the vent alarm, it's not like the oxygen saturation alarm, so I didn't think anything of it". RN 1 stated that LVN 1 was seen going into Patient 1's room and then came out and called RN 1 for help. RN 1 stated that she went into Patient 1's room and found the patient unresponsive.


On 5/8/14 at 1:20 P.M., an interview was conducted with RN 3 (the Charge Nurse on the night of the ventilator event). RN 3 stated that she was at the nursing station from 2:45 A.M. through 3:30 A.M. She acknowledged that she heard "multiple" alarms sounding during this time period. RN 3 acknowledged that she did not respond to those alarms, as she was receiving a nursing report. In addition, she stated she saw LVN 1 enter the patient's room at some point. RN 3 stated that the telemetry technician (TT) 2 called the nursing station (unsure of time) and informed her that Patient 1 was "desaturating" (oxygen level in blood drops). Immediately following the phone call from TT 2, RN 3 heard LVN 1 come out of Patient 1's room and yell, "I need help, call rapid response (a process when a team of licensed staff responds to a medical emergency)." RN 3 called the Rapid Reponse Team.



On 5/8/14 at 2:00 P.M., an interview was conducted with LVN 1. LVN 1 was assigned to Patient 1. LVN 1 stated that the last page she received for Patient 1 was at 3:11 A.M., while providing care and repositioning the patient. LVN 1 denied receiving any other pages for Patient 1 after 3:11 A.M. LVN 1 stated, at some point during her shift (was unable to provide the exact time), RN 3 told her that Patient 1 was desaturating so she went into Patient 1's room and found Patient 1 unresponsive and cyanotic (bluish discoloration of the skin from a lack of oxygen). LVN 1 stated that she yelled to call rapid response.


On 5/8/14 at 3:21 P.M., an interview was conducted with RN 5 (a resource nurse). RN 5 heard the rapid response call and went to Patient 1's room. RN 5 stated that RT 3 came a few seconds after her. RN 5 stated that RT 3 informed her, that she (RT 3) saw Patient 1's expiratory limb disconnected at the Y connector (a Y shape tube that attaches the inspiratory and expiratory limbs to the patient).


On 5/8/14 at 2:53 P.M., an interview was conducted with TT 2. TT 2 was assigned to the Oxinet system on the night of the event. TT 2 stated that at approximately 3:00 A.M., the Oxinet paging system was alarming for Patient 1 due to high pulse rate. TT2 stated that she called the nursing station, but no one answered. TT 2 stated she called the nurses station a second time. She could not recall the time between calls. TT 2 stated that RN 1 answered the phone on the second call, and that RN 1 was informed of Patient 1's Oxinet high pulse rate alarm. TT 2 stated that when Patient 1's oxygen saturation started to drop, she called the nurses station a third time. TT 2 stated that RN 3 answered the phone and she informed RN 3 of Patient 1's Oxinet alert due to the patient's drop in oxygen saturation.



On 5/8/14 at 4:55 P.M., an interview was conducted with RT 3. RT 3 stated that she was assigned to Patient 1 due to Patient 1's preference for female caregivers. RT 3 stated LVN 1 called her cellular phone to inform her that Patient 1 requested to be suctioned. RT 3 stated that she asked LVN 1, "Why are you calling me for suction?" RT 3 stated that LVN 1 responded, "I am busy and the patient is desaturating". RT 3 stated she heard the rapid response called shortly after the call ended. RT 3 stated that she went to Patient 1's room and noticed the expiratory limb was disconnected. RT 3 denied that she had received any pages for Patient 1 on her shift.


The hospital's policy and procedure titled, "Ventilator Patient Management", revised on 3/13, indicated that, "All healthcare staff will respond to ventilator alarms to determine cause and notify Respiratory Care when needed". This policy was not implemented when nursing staff and RT staff did not respond to Patient 1's ventilator alarms for 12 minutes.


On 5/12/14 at 10:02 A.M., an interview with DQM and the CCO was conducted. Both the DQM and CCO acknowledged that the nursing staff did not provide the appropriate care to address Patient 1's needs when the patients ventilator alarms was not answered for 12 minutes, which resulted in an anoxic brain injury.

Based on observation, interview, and record review, the hospital failed to provide documented evidence that 1 of 30 sampled patient's (16) pain status was reassessed after the administration of pain medication in accordance with the hospital's own policy and procedure. The hospital also failed to ensure that a written care plan was developed related to Patient 16's pain. Failure to document the reassessment of the patients' pain status after the administration of the pain medication made it difficult to determine whether or not the patient's pain status was reassessed. It also prevented staff and other healthcare providers' the ability to determine the effectiveness of the pain medication administered and the patient's comfort level. In addition, the hospital failed to ensure care plans were kept updated to reflect the current status for 3 of 30 sampled patients (3, 6, 12). Failure to update the patient's care plan may prevent the communication of the patient's current health needs and interventions to all healthcare providers.


Findings:


1. A tour of the hospital's Medical/Surgical (Med/Surg) unit on 3 East was conducted on 5/12/14 at 2:39 P.M. Patient 16 was observed in bed with eyes closed.


A review of Patient 16's medical record was conducted on 5/12/14 at 3:20 P.M. The patient was admitted to the hospital on 4/10/14 with diagnoses that included respiratory failure per the History and Physical, dated 4/11/14.


A review of the physician's order, dated 5/11/14 at 9:04 P.M., indicated an order for Patient 16 to receive morphine sulfate (pain medication) 2 mg (milligrams) intravenously (IV) every 6 hours as needed for severe pain (scale of 7 - 10).


A review of the medication administration record (MAR), dated 5/12/14, indicated that Patient 16 was given morphine sulfate 2 mg on 5/12/14 at 3:14 A.M. for a pain of 8 (severe pain). Per the same record, the patient's pain status was not reassessed until 6:55 A.M., 3 hours and 41 minutes after the pain medication was administered. The patient's pain status was reassessed at "2".


Further review of Patient 16's medical record showed no written care plan developed to address the patient's pain.


A joint record review and interview with registered nurse (RN) 17 was conducted on 5/13/14 at 8:10 A.M. RN 17 stated that Patient 16 was not able to verbalize pain. RN 17 stated that on 5/12/14 at 3:14 A.M., the patient was grimacing and was showing discomfort. RN 17 stated that she assessed the patient's pain at "8" (severe pain) and gave the patient morphine sulfate 2 mg as ordered. RN 17 acknowledged that the documented pain reassessment indicated that the reassessment was done 3 hours and 41 minutes after the IV pain medication was administered. RN 17 stated that the hospital's policy was to reassess the patient's pain status within 30 minutes following the administration of IV pain medication. RN 17 also acknowledged that a written care plan related to the patient's pain was not developed.


A review of the hospital's policy and procedure titled Nursing Care Planning, revised on 3/11, was conducted on 5/13/14 at 9:00 A.M. The policy indicated that, "1. Nurse Responsibility: All patients shall be assessed on admission, and a written plan of care developed and initiated by an RN. The plan of care shall reflect the needs applicable to the individual patient." This policy was not followed when a written care plan related to Patient 16's pain was not developed.


An interview with the Med/Surg unit manager (MSUM) was conducted on 5/13/14 at 9:10 A.M. The MSUM stated that the hospital's policy was to reassess the patient's pain status within 30 minutes following the administration of IV pain medication. The MSUM acknowledged that the documented reassessment of Patient 16's pain status was not in accordance to the hospital's policy. The MSUM also acknowledged that a written care plan related to the patient's pain should have been developed.


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2. Patient 3 was admitted to the hospital on 7/10/13 with diagnoses that included progressive quadriplegia (unable to move, feel both arms and legs) per the History and Physical (H&P), dated 7/10/13.

On 5/14/14 at 1:46 P.M., a review of Patient 3's medical record was conducted. The patient's care plans were reviewed and indicated a problem titled "Potential for Injury Related to Restraints (active) assigned: 07/10/13." Further review of the medical record revealed no other documentation related to the use of restraints for Patient 3.

On 5/14/14 at 2:18 P.M., a joint observation and interview was conducted with Patient 3. Patient 3 stated that he did not have any restraints, and no restraints were observed.

On 5/14/14 at 2:20 P.M., an interview was conducted with Registered Nurse (RN) 7. RN 7 stated that Patient 3 was a forensic patient (term used for an incarcerated patient) in the past but was no longer. At the time the patient was a forensic patient, the patient's ankle were cuffed together.

The hospital's policy and procedure titled "Nursing Care Planning", revision date 3/11 indicated,"3. Plan of Care Review and Update: The patient's plan of care shall be reviewed and updated at least daily by a licensed nurse... Care plans will be reviewed weekly by the interdisciplinary team at the scheduled patient care plan conference." This policy was not followed when Patient 3's care plan did not reflect the patient's current status related to restraint use.

3. Patient 6 was admitted to the hospital on 5/9/14 with diagnoses that included chronic renal failure (progressive loss in renal function) per the History and Physical (H&P), dated 5/9/2014.

On 5/14/14 at 10:40 A.M., a review of Patient 6's medical record was conducted. The care plans were reviewed and indicated a problem titled, "Potential for Injury Related to Restraints (active) assigned: 06/12/14." Further review of the medical record revealed no other documentation related to the use of restraints for Patient 6.

On 5/14/14 at 11:00 A.M., an observation of Patient 6 was conducted with Licensed Vocational Nurse (LVN) 3. Patient 6 was observed in bed receiving dialysis (a machine that filters waste products from the blood when the kidneys don't work well) and with family at the bedside. No restraints were observed and LVN 3 stated that Patient 6 did not have any restraints.

The hospital's policy and procedure titled "Nursing Care Planning", revision date 3/11 indicated, "3. Plan of Care Review and Update: The patient's plan of care shall be reviewed and updated at least daily by a licensed nurse... Care plans will be reviewed weekly by the interdisciplinary team at the scheduled patient care plan conference." This policy was not followed when Patient 6's care plan did not reflect the patient's current status related to restraint use.

4. Patient 12 was admitted to the hospital on 5/8/14 with diagnoses that included adenocarcinoma (cancer) of the lung per the History and Physical (H&P), dated 5/8/14.

On 5/13/14 at 9:11 A.M., a review of Patient 12's medical record was conducted. The care plans were reviewed and indicated a problem titled "Potential for Injury Related to Restraints (active) assigned: 05/08/14." Further review of the medical record revealed no other documentation related to the use of restraints for Patient 12.

On 5/14/14 at 9:11 A.M., an observation of Patient 12 was conducted with Registered Nurse (RN) 9. Patient 12 was observed in bed and no restraints were observed in use. RN 9 stated that Patient 12 did not have any restraints, and that there should not be an active care plan related to the use of restraints.

The hospital's policy and procedure titled "Nursing Care Planning", revision date 3/11, indicated, "3. Plan of Care Review and Update: The patient's plan of care shall be reviewed and updated at least daily by a licensed nurse... Care plans will be reviewed weekly by the interdisciplinary team at the scheduled patient care plan conference." This policy was not followed when Patient 12's care plan did not reflect the patient's current status related to restraint use.

Based on interview, record and document review, the hospital failed to ensure policies and procedures were adequately developed to define staff responsibilities when there was an assignment change. The wrong Respiratory Therapist (RT) was assigned to Patient 1 via the paging system,"Oxinet" (an electronic paging system designed to send alerts to staff via a beeper device). The Oxinet paging system sent multiple alerts to Respiratory Therapist (RT) 1 that went unanswered for 12 minutes. In addition, the hospital's policy titled "Ventilator Patient Management", failed to establish any required ventilator alarm response times for staff. Patient 1's ventilator alarm went unanswered for 12 minutes by Licensed Nurse and Respiratory Therapy staff, which resulted in Patient 1 sustaining an anoxic brain injury (injury to the brain due to a lack of oxygen) with a poor prognosis, per the patient's attending physician.


Findings:


1. Patient 1 was admitted to the hospital on 2/11/14 with diagnoses that included hypercarbic respiratory failure (failure of the oxygenation and carbon dioxide elimination in the lungs), pulmonary hypertension (increased pressure in the pulmonary arteries) and right-sided congestive heart failure (the right side of the heart doesn't pump blood to the lungs normally), per the History and Physical (H&P), dated 2/11/14. Per the same document, Patient 1 required a ventilator (machine designed to move air in and out of the lungs). According to the "Patient Care Notes", dated 2/11/14 at 11:00 P.M., Patient 1 was assessed as alert and oriented x 3 (name, place and time).


On 5/7/14 at 1:45 P.M., an interview was conducted with the Director of Quality Management (DQM) and the Chief Clinical Officer (CCO). The DQM and the CCO both acknowledged that an internal investigation had been started and that the event involving Patient 1 was due to human error and not ventilator malfunction. The DQM and CCO stated that two Registered Nurses (RN), one of whom was the Charge Nurse (RN 3), were at the nursing station and heard the alarm, but did not respond. In addition, multiple pages were sent to RT 1 and LVN 1, and those pages went unanswered.

On 5/7/14 at 2:25 P.M., an observation was conducted of the room that Patient 1 was in at the time of the ventilator event. Patient 1's room was located on the medical/surgical floor and was located 13' from the nurses station per the measurement of the hospital maintenance staff. An external alarm box was located on the wall outside the door of Patient 1's room. The external alarm was tested, and delivered a loud beeping sound and flashing red light when activated. The alarm was audible and visible from the nursing station.


On 5/7/14 at 2:35 P.M., an interview was conducted with RN 6. RN 6 acknowledged that she had cared for Patient 1 prior to the event and that Patient 1 was alert, able to communicate her needs by writing and was able to use the call light. In addition, she was able to move her hands, arms and was able to eat meals by mouth. RN 6 stated that staff were required to respond immediately to a ventilator alarm.


On 5/7/14 at 2:40 P.M., an interview was conducted with the Director of Respiratory Therapy (DRT). The DRT stated that if the oxygen saturation (O2 sat- the amount of oxygen in the blood) and heart rate (pulse) fell outside of the preset parameters for a patient, it would send a page alert to the RT and nursing staff assigned to that patient.


On 5/7/14 at 2:55 P.M., a joint observation of Patient 1 was conducted with RN 2. Patient 1 was transferred to the Intensive Care Unit (ICU) after the ventilator event. RN 2 stated that Patient 1 was non-responsive except to painful stimuli. Per RN 2, Patient 1 would open her eyes but did not track or follow (neurological assessment tool used to check brain function in an unresponsive patient). Patient 1 did not demonstrate any purposeful movement and she was not on any medications that would inhibit purposeful movements. RN 2 stated Patient 1 had been administered Dopamine (intravenous medication to treat low blood pressure) intermittently since the ventilator event to maintain adequate blood pressure.


On 5/7/14 at 3:30 P.M., a joint observation of the ventilator used by Patient 1, at the time of the event, was conducted with the DRT. The DRT stated that the expiratory limb (tubing from the patient to the machine that filters carbon dioxide) was disconnected from Patient 1 at the time of the event. Using the ventilator, the DRT demonstrated the ventilators settings and parameters that were set for Patient 1 at the time of the event. The DRT then disconnected the expiratory limb. The ventilator alarm was heard within 4-seconds of the disconnection, and continued to alarm until reconnected.

On 5/8/14 at 12:51 P.M., an interview was conducted with RN 1. RN 1 was partnered with LVN 1 on the night of the ventilator event. Both RN 1 and LVN 1 were responsible for Patient 1's care. The LVN's scope of practice limited LVN 1's ability to perform certain duties to care for Patient 1. Therefore, RN 1, being the Registered Nurse, had ultimate responsibility for Patient 1's over all care. RN 1 stated she was at the nursing station and heard Patient 1's ventilator alarming. RN 1 stated, "It was just the vent alarm, it's not like the oxygen saturation alarm, so I didn't think anything of it". RN 1 stated that LVN 1 was seen going into Patient 1's room and then came out and called RN 1 for help. RN 1 stated that she went into Patient 1's room and found the patient unresponsive.


On 5/8/14 at 1:20 P.M., an interview was conducted with RN 3 (the Charge Nurse on the night of the ventilator event). RN 3 stated that she was at the nursing station from 2:45 A.M. through 3:30 A.M. She acknowledged that she heard "multiple" alarms sounding during this time period. RN 3 acknowledged that she did not respond to those alarms, as she was receiving a nursing report. In addition, she stated she saw LVN 1 enter the patient's room at some point. RN 3 stated that the telemetry technician (TT) 2 called the nursing station (unsure of time) and informed her that Patient 1 was "desaturating" (oxygen level in blood drops). Immediately following the phone call from TT 2, RN 3 heard LVN 1 come out of Patient 1's room and yell, "I need help, call rapid response (a process when a team of licensed staff responds to a medical emergency)." RN 3 called the Rapid Reponse Team.



On 5/8/14 at 2:00 P.M., an interview was conducted with LVN 1. LVN 1 was assigned to Patient 1. LVN 1 stated that the last page she received for Patient 1 was at 3:11 A.M., while providing care and repositioning the patient. LVN 1 denied receiving any other pages for Patient 1 after 3:11 A.M. LVN 1 stated, at some point during her shift (was unable to provide the exact time), RN 3 told her that Patient 1 was desaturating so she went into Patient 1's room and found Patient 1 unresponsive and cyanotic (bluish discoloration of the skin from a lack of oxygen). LVN 1 stated that she yelled to call rapid response.


The hospital's policy and procedure titled, "Ventilator Patient Management", revised on 3/13, indicated that, "All healthcare staff will respond to ventilator alarms to determine cause and notify Respiratory Care when needed". The hospital's policy and procedure did not establish clear expectations of safety regarding response time to ventilator and other patient alarms for all patients






2. Patient 1 was admitted to the hospital on 2/11/14 with diagnoses that included hypercarbic respiratory failure (failure of the oxygenation and carbon dioxide elimination in the lungs), pulmonary hypertension (increased pressure in the pulmonary arteries) and right-sided congestive heart failure (the right side of the heart doesn't pump blood to the lungs normally), per the History and Physical (H&P), dated 2/11/14. Per the same document, Patient 1 required a ventilator (machine designed to move air in and out of the lungs). According to the "Patient Care Notes", dated 2/11/14 at 11:00 P.M., Patient 1 was assessed as alert and oriented x 3 (name, place and time).


On 5/7/14 at 1:45 P.M., an interview was conducted with the Director of Quality Management (DQM) and the Chief Clinical Officer (CCO). The DQM and the CCO both acknowledged that an internal investigation had been started and that the event involving Patient 1 was due to human error and not ventilator malfunction. The DQM and CCO stated that two Registered Nurses (RN), one of whom was the Charge Nurse (RN 3), were at the nursing station and heard the alarm, but did not respond. In addition, multiple pages were sent to RT 1 and LVN 1, and those pages went unanswered.


On 5/7/14 at 2:40 P.M., an interview was conducted with the Director of Respiratory Therapy (DRT). The DRT stated that if the oxygen saturation (O2 sat- the amount of oxygen in the blood) and heart rate (pulse) fell outside of the preset parameters for a patient, it would send a page alert to the RT and nursing staff assigned to that patient.


On 5/7/14 at 3:30 P.M., a joint observation of the ventilator used by Patient 1, at the time of the event, was conducted with the DRT. The DRT stated that the expiratory limb (tubing from the patient to the machine that filters carbon dioxide) was disconnected from Patient 1 at the time of the event. Using the ventilator, the DRT demonstrated the ventilators settings and parameters that were set for Patient 1 at the time of the event. The DRT then disconnected the expiratory limb. The ventilator alarm was heard within 4-seconds of the disconnection, and continued to alarm. The DRT stated that the ventilator was set to give 20 breaths per minute and would alarm with every ventilated breath until the expiratory limb was reconnected. In addition, the DRT stated that a page via the Oxinet pager system would send a page to RT 1 and LVN 1 when the oxygen saturation or heart rate went out of the preset parameters.


On 5/8/14 at 4:15 P.M., a joint review of the Oxinet report, dated 5/5/14, was conducted with the DQM. The report revealed that RT 1 received 23 pages for Patient 1 related to a high pulse rate and O2 saturation decline. Per the same report, LVN 1 received 24 pages for Patient 1. The DQM stated that RT 3 was assigned to Patient 1 on the night of the ventilator event, but RT 3's Oxinet pager did not included Patient 1. Instead, Patient 1 was assigned to RT 1's Oxinet pager. Therefore, Patient 1's ventilator alert pages were sent to RT 1 instead of RT 3.


On 5/8/14 at 4:22 P.M., an interview was conducted with RT 1. RT 1 denied that Patient 1 was assigned to him on the night of the ventilator event. RT 1 stated that he received pages from the Oxinet system for his assigned patients, but denied receiving any pages for Patient 1. RT 1 also stated, "It didn't matter if I didn't get a page for Patient 1, the nurses get the pages too and they should have responded." RT 1 denied any assignment changes during his shift.


On 5/8/14 at 4:55 P.M., an interview was conducted with RT 3. RT 3 stated that she was assigned to Patient 1 due to Patient 1's preference for female caregivers. RT 3 stated LVN 1 called her cellular phone to inform her that Patient 1 requested to be suctioned. RT 3 stated that she asked LVN 1, "Why are you calling me for suction?" RT 3 stated that LVN 1 responded, "I am busy and the patient is desaturating". RT 3 stated she heard the rapid response called shortly after the call ended. RT 3 stated that she went to Patient 1's room and noticed the expiratory limb was disconnected. RT 3 denied that she had received any pages for Patient 1 on her shift.


On 5/12/14 at 2:55 P.M., an interview was conducted with RT 4. RT 4 was asked what he would do if his patient assignment was changed in the middle of his shift. RT 4 was not able to verbalize the process of notifying the tele tech to ensure that the Oxinet pagers were reassigned to the correct RT.


On 5/12/14 at 3:00 P.M., a surveyor interviewed RT 16. RT 16 was also asked what she would do if her patient assignment was changed in the middle of her shift. RT 16 was not able to verbalize the process of notifying the tele tech to ensure that the Oxinet pagers were reassigned to the correct RT.


On 5/13/14 at 9:17 A.M., an interview was conducted with RT 5. RT 5 was asked what she would do if her patient assignment was changed in the middle of her shift. RT 5 was not able to verbalize the process of notifying the tele tech to ensure that the Oxinet pagers were reassigned to the correct RT.

On 5/13/14 at 3:51 P.M., an interview was conducted with the UC. The UC took over TT 4's responsibility and made the pager assignments on the night of the ventilator event. The UC stated she took over the telemetry and Oxinet system at 5:30 P.M. and had made the pager assignments for the RNs, LVNs, and RTs. The UC stated that she had assigned Patient 1 to RT 1's pager per the assignment sheet she received from the day shift RT lead.

On 5/12/14 at 10:02 A.M., an interview with DQM and the CCO was conducted. The CCO stated that the process of informing the tele techs of any reassignments for RTs and licensed nurses was not a written policy but was the expected practice. Without a written policy and procedure, the staff did not have clear directions on what to do when reassignments occurred during their shift.