The following reflects the findings of the Department of Public Health during a Complaint Investigation visit:
CLASS AA CITATION -- PATIE NT CARE
Complaint (s): CA00143412
Representing the Department of Public Health:
Surveyor 10 # 22232, HFEN
The inspection was limited to the specific facility event investigated and does not represent the findings of a full inspection of the facility,
REGULATION VIOLATION: Title 22
723 1 1 - Nursing Services - General
72523 Patient Care Policies and Procedures
72311 (a) Nursing service shall include, but not be limited to, the following:
(1) Planning of patient care, which shall include at least the following:
(A) Identification of care needs based upon an initial written and continuing assessment of the patient's needs with input, as necessary, from health professionals involved in the care of the patient. Initial assessments shall commence at the time of admission of the patient and be completed within seven days after admission,
The facility failed to ensure patient care included a continuing assessment of Patient 1, which would include input from health professionals involved in the patient's care. The facility failed to ensure nursing and respiratory therapy staff provided a continued assessment of Patient 1's respiratory status, which included the patient's respiratory ventilator equipment.
(a) Written patient care policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved.
The facility failed to ensure the policy and procedure pertaining to ventilator equipment, specifically, alarm settings, was conSistently implemented. On February 2, 2008 at 7:25 AM, Patient 1 was observed without respirations; no chest rises and falls were noted. The patient's ventilator gauges showed abnormal readings and the ventilator alarm was not audible. The ventilator tubing was found disconnected, Patient 1 expired on February 2, 2008 approximately 15 minutes later.
On March 20, 2008 at 3:55 PM, an unannounced visit was made to the facility to investigate an event regarding a ventilator (machine that breathes for or assists a patient to breathe) dependent patient becoming disconnected from the ventilator and dying shortly thereafter.
Patient 1 was admitted to the facility on July 27, 2007, with diagnoses which included asthmatic bronchitis with emphysema and was ventilator dependent.
The medical record included a care plan for Patient 1, which had been revised on November 6, 2007. The care plan addressed the patient's problem/concern of, "At risk for respiratory distress RIT (related to) ventilator tubing disconnection". The expected outcome was, "Staff will respond to ventilator alarms promptly all the time while resident is ventilator dependent". The intervention was to, "Check ventilator tubing connection before and after transfers and during ADL (activities of daily living) . . . respond to ventilator alarms ASAP (as soon as possible)".
An "NCU Daily Interdisciplinary Progress Note" dated February 2, 2008 at 9:00 AM, by the Licensed Vocational Nurse (LVN 1) caring for Patient 1, detailed the event involving Patient 1. The note stated the Certified Nursing Assistant (CNA1) called the nurse into the room, at 7:15 AM, to check the patient, as "The patient was not opening his eyes or moving when she touched him". LVN 1 further documented that she did not see anything disconnected on the ventilator and the alarm was not going off. LVN 1 further documented that she checked the patient's heart rate, which was 80, then left the room and asked the Respiratory Therapist (RT) to check on the patient.
LVN 1 documented, "About 5 mins. later RT came and got me wanting to show me what was disconnected from the vent (ventilator)".
At 7:55 AM, LVN 1 documented, "RT came out of the room stating the patient had no V IS (vital signs). I went back in the room and verified no VIS, Charge nurse notified".
On February 2, 2008 at 8 : 10 AM, the RN documented, "Pt without BP (blood pressure), P (pulse), spontaneous respirations. Pupils fixed. No response to sternal rub, Pronounced dead .. ".
On March 20, 2008, during review of the "Neurological Care Unit Mechanical Ventilation Record" dated February 2, 2008, the following "late entry" (documentation entered at a time later than the care was performed) for 7:25 AM, indicated the ventilator check was completed. On the back side of the form, the narrative, completed by RT 2, showed, "Received pt from NOC (night) shift on documented settings. 0725 L VN 1 called myself and (RT 1) to pt room because pt did not look right. Upon entry into the room the vent circuit was confirmed and I assessed the pt and confirmed ventilator settings and function. 0745 Upon entry into the room the pt was found pulseless and with no heart sounds. RN notified."
On March 25, 2008 at 11: 15 AM, a telephone interview was conducted with RT 1. RT 1 stated a nursing staff member asked the RT to come to Patient 1's room to check on him. RT 1 stated upon entering Patient 1 's room at approximately 7: 15 AM on February 2, 2008, there was no rise and fall chest movement of Patient 1. RT 1 stated the ambu bag (a bag connected to oxygen to assist or give respirations to a patient) was obtained, but it was then observed the ventilator circuit (tubing connecting the patient to the ventilator) was disconnected at the vent. RT 1 stated the alarms on the ventilator were not audible. RT 1 stated the vent tubing was reconnected and observation then showed the patient's chest rise and fall as soon as it was reconnected.
RT 1 further stated that there had not been a vent check done on the shift yet, as they had not started their vent checks for the shift and they were still checking the medical charts and physician orders.
On April 7, 2008, a telephone interview was conducted w ith RT 2. R T 2 stated that some time around 7:25 AM on February 2, 2008, RT 2 was asked by a nurse to check on Patient 1. RT 2 stated upon entering the patient's room, observation showed no chest rise and fall. RT 2 stated there was no audible ventilator alarm. RT 2 stated the gauges on the ventilator were showing abnormal readings, so an ambu bag was obtained to give the patient manual respirations. RT 2 continued that it was then noticed the ventilator tubing was disconnected at the vent. The tubing was reconnected and respirations were observed.
RT 2 stated upon returning to the patient's room about 15 minutes later, the patient had no heart sounds or pulse. The charge nurse was summoned to the room; the charge nurse stated the patient had just expired.
RT 2 further stated that a ventilator check had not been done yet and that the last documented "vent check" had been at about 3:00 AM. RT 2 further stated, the Respiratory Care Manager, "made me write the vent check" when the ventilator check had actually not been done.
On April 7, 2008 at 10:15 AM, an interview was conducted with LVN 1, the LVN provided care to Patient 1 on February 2, 2008. L VN 1 stated that during the change of shift report, CNA 1 summoned LVN 1 to Patient 1 's room. CNA 1 stated the patient was not very responsive. LVN1 further stated she went to the patient's room, checked the patient's pulse and vital signs, which she stated were stable. L VN 1 stated there were no machine alarms sounding. LVN 1 stated that increased flaccidity (increased muscle weakness), which was noted from the day before, was observed.
LVN 1 stated 2 RT's were informed of the concerns; LVN 1 left the RT's with the patient. LVN 1 continued to state that 15 minutes later, one of the RT's informed the LVN that the ventilator had been "unplugged".
LVN 1 then stated that at 8:00 AM, Patient 1 was noted to have no vital signs. LVN 1 notified the charge nurse, who responded and went into the patient's room.
On February 2, 2008 at 8: 1 0 AM, Patient 1 was pronounced dead.
On April 9, 2008 at 10:40 AM, an interview was conducted with CNA 1. CNA 1 stated she was familiar with Patient 1, as she had cared for him many times before. CNA 1 then stated the patient was "different " from other days, "his eyes would not open" and he seemed "weird" to her. CNA 1 stated she then requested L VN 1 to come to the room to check the patient. CNA 1 stated she didn't think the patient "was o.k. " CNA 1 stated LVN 1 came to the patient's room and said, "He's o.k." CNA 1 stated she responded, "Not to me" and stayed in Patient 1 's room for 10 to 15 minutes, observing the patient. CNA 1 stated that there was not an audible ventilator alarm sounding during the time she was in the room.
CNA 1 stated she called L VN 1 to Patient 1 's room a second time to check the patient's condition. LVN 1 returned to the room and then called for R T assistance. CNA 1 stated she left the room when RT came to the room.
Record review of the facility's "Respiratory Procedures Provided by Licensed Nursing Staff in N C U " was conducted on April 9, 2008. Documentation showed, under Policy: 3.0, licensed personnel will demonstrate appropriate competence in VENTILATOR TRO U BLE-SHOOTING . . .4.0 NurSing staff will demonstrate competency annually."
An interview was conducted on April 9, 2008 at 10:50 AM, with the Director of Nurses ( DON). She stated, "Yearly competencies are conducted on ventilator management". However, the DON was unable to provide completed proof of LVN 1 's competency for caring for ventilated patients. The DON provided blank clinical competency forms for CNAs, LVNs and RNs, with a year date of 2007.
LVN 1 's personnel file showed a "Competency Assessment Ventilator Troubleshooting," dated September 9, 2005. Review of LVN 1's "Education Department Individual's Class Profile," which reflected the classes and competencies taken January 1, 2005 through April 9, 2008, did not include an annual competency for ventilator dependent patients.
An interview was conducted on April 9, 2008 at 11 :50 AM, with the Respiratory Supervisor. She stated that alarm volumes on ventilators can only be adjusted by Biomed personnel. She also stated that the alarms can be turned off from the front of the ventilator. She stated that RTs are usually the staff who change alarm settings. Additionally, she stated nursing staff "know how, but are not supposed to adjust the alarms".
On April 9, 2008 at 1 220 PM, demonstration of the "vela" ventilator and alarms was requested and conducted. Room 37 had a vela ventilator set up in it, but the room was unoccupied. The RT demonstrated how the alarms could be turned off on the machine and made inaudible during a disconnection.
The facility's policy and procedure regarding ventilator alarm settings, was reviewed on April 9, 2008. Under the section "R" Respiratory, Subject: Ventilator Alarm Settings," the following was noted: "It is the policy of this facility to determine the resident's peak airway pressure; check the high and low pressure alarm settings; and adjust the alarm settings to maintain (the above) parameters every 4 hours."
In addition, the policy stipulated to check the patient's peak airway pressure every four hours and adjust the alarm settings as needed to maintain the parameters and document the ventilator alarm settings in the patient's record.
The facility's document, "Ventilator Alarm Classification and Setting," under "Ventilator Alarm Classifications," stated. Ventilator Malfunction Level Level 2 Non-critical 2 alarms may be potentially Life-threatening. Level 2 alarms provide both visual and audio alarms, which are non-continuous. The audio alarm will cease, if the condition is resolved. The alarm may be cancelled or reset by the clinician. Examples of level 2 Alarms include: circuit leak, circuit blockage, pressure, volume and PEEP alarms are set and maintained by the clinician .. ,"
Based on the information obtained, the facility failed to ensure only staff trained and proficient in caring for ventilator dependent patients, care for them. The facility failed to ensure staff caregivers maintained yearly competency, as stipulated in their policy and procedure. In addition, the facility failed to ensure staff performed ventilator checks every four hours as required. Additionally, the facility failed to ensure patient care included a continuing assessment of Patient 1. Staff failed to continually assess Patient 1 after the patient was noted with a change in his respiratory status. As a result, Patient 1 died. These violations presented an imminent danger that death or serious harm would result or a substantial probability that death or serious physical harm would result, and were a direct proximate cause of death of the patient.