O'Connor Hospital D/P SNF
2105 Forest Ave. San Jose, CA 95128
Citation Number: 070009756
Citation Date: 03/05/2013
Violation Date: 12/26/2012
Class: AA
Penalty: $65,000

CLASS AA CITATION-- PATIENT CARE

F323- 483.25(h) FREE OF ACCIDENT HAZARDS/SUPERVISION/DEVICES The facility must ensure that the resident environment remains as free of accident hazards as is possible; and each resident receives adequate supervision and assistance devices to prevent accidents.

The facility failed to ensure the resident environment remained free of accident hazards for one of one sampled resident(1) when Resident 1's ventilator (a machine that provides breaths to the lungs via an artificial opening in the neck [tracheostomy]) was left in standby mode (machine remains on but delivery of air to resident and disconnect/safety alarms are suspended). Resident 1 was found unresponsive and lifesaving measures were initiated. The resident was transferred to the intensive care unit for a higher level of care. The resident expired soon after.

Resident 1 was admitted to the facility on 8/14/12 with diagnoses including amyotrophic lateral sclerosis (ALS - a progressive disease that affects the brain's ability to initiate and control muscle movement, in later stages of ALS the muscles involved with breathing begin to deteriorate and the act of breathing is no longer automatic) and quadriplegia (paralysis of the arms and legs) and required mechanical ventilation (breathing by ventilator). Review of Resident 1 's ventilator settings ordered by Physician 1 (PH 1) dated 8/14/12 indicated MODE ACVC (assist control/volume control) [ventilator provides a full breath for every breath attempted by the resident) at a Tidal Volume (size of each breath) of 450 milliliters per breath.

On 2/19/13 at 10 a.m. review of Resident 1's minimum data set (MDS resident assessment and care screening form) dated 12/26/12 indicated Resident 1 had memory problems, and moderately impaired decision making capacity for tasks of daily life. The MDS further indicated Resident 1 was fully dependent on staff for bed mobility and activities of daily living.

In an interview on 1/10/13 at 10 a.m., Respiratory Therapist 1 (RT 1) stated he provided care for Resident 1 since her admission to the facility and was familiar with the resident. RT 1 further stated although Resident 1 required mechanical ventilation she was able to breathe on her own for minutes at a time. On the morning of 12/26/12 at approximately 9:10 a.m. RT 1 performed tracheostomy care for Resident 1. Tracheostomy care per RT 1 included cleaning the tracheostomy site and changing the inner tracheostomy cannula. The tracheostomy device has an outer cannula to maintain the patency of the airway and an inner cannula that fits snugly inside the outer cannula that can be removed for cleaning and removal of accumulated secretions without disturbing the operative site.

RT 1 further stated during the procedures the ventilator was changed to standby mode prior to disconnecting the resident from the ventilator. RT 1 stated he disconnected the resident from the ventilator for a couple of seconds during the procedure and then reconnected the resident to the ventilator. After the tracheostomy (trach) care was completed, RT 1 stated he deflated the tracheostomy cuff (a balloon around the distal end of the cannula which forms a seal between the tracheostomy tube and the trachea when the cuff is inflated) so Resident 1 could speak but the resident turned her head away and appeared to fall asleep. RT 1 further stated it was not unusual for Resident 1 to withdraw at times by turning away her head. RT 1 re-inflated the cuff and proceeded to the next resident.

RT 1 also stated during the above interview he was called back into Resident 1's room by her primary nurse (LVN 1) at approximately 9:25 a.m. because the resident was non-responsive. RT 1 stated he attempted to stimulate the resident but was unsuccessful. Resident 1's pulses were difficult to palpate (unable to find a pulse) and therefore he initiated cardiopulmonary resuscitation (CPR) (an emergency procedure in which the heart and lungs are made to work manually). During the emergency event, RT 1 and LVN 1 noticed the ventilator was on standby mode (machine on, but not ventilating the resident). When asked, RT 1 stated he did not recall if he placed the machine back on ventilating mode after completing Resident 1's tracheostomy care.

In an interview on 1/10/13 at 11 a.m., LVN 1 stated that on 12/26/12 at approximately 9:15 a.m. she went into Resident 1 's room to give her medications. Once she arrived in the room she noticed Resident 1 was unresponsive and immediately called the charge nurse and RT 1 into the resident's room for assistance. Due to Resident 1 's condition a code blue (medical emergency in which a team of medical personnel work to revive an individual in cardiac arrest) was called for Resident 1. LVN 1 stated she noticed Resident 1's ventilator was on standby mode.

On 1/10/13 at 11:15 a.m. a review was conducted of LVN 1's note dated 12/26/12 at 9:30 a.m. LVN 1 documented she "went to resident room to give morning medications at 9:25 a.m. found resident unresponsive, no pulse noted called respiratory therapy for help, called charge for help, called code blue."

On 1/10/13 at 11:30 a.m. review of Resident 1 's discharge summary note dated 12/28/12 by Physician 1 (PH 1) indicated the resident was transferred to the intensive care unit on 12/26/12 for respiratory and cardiac arrest. The note further indicated Resident 1 "had been stable in the subacute unit for several months...She had been doing well on her ventilator until today...Neurologically she is intact". The note further indicated the resident "had a respiratory arrest as the vent was not functioning for her and then went into cardiac arrest...when she was noticed, she was pulseless and a code blue was called."

On 1/10/13 at 11:45 a.m., review of Resident 1 's consultation report by Physician 2 (PH 2) dated 12/28/12 indicated on 12/26/12 "a trach change was completed but there were some complications with the ventilator after the trach change and the resident went into respiratory arrest."

On 1/10/13 at 12 p.m. further review of Resident 1's medical record indicated the resident's condition worsened in the intensive care unit and Resident 1 passed away on 12/28/12 at 10:03 p.m.

On 1/10/13 at 12:30 p.m. during a telephone interview with PH 1, he stated prior to the event on 12/26/12 Resident 1 was able to breathe on her own (without the ventilator assistance) for minutes at a time. PH 1 stated he could not say for certain if the cause of Resident 1's respiratory event was due to the ventilator being left on standby mode. PH 1 further stated Resident 1's cause of death was brain anoxia (brain does not receive adequate oxygen), secondary to acute respiratory failure (resident's lungs do not provide adequate ventilation to the body).

On 2/19/13 at 7:14 a.m. via a fax, the risk manager indicated the facility did not have a policy and procedure regarding use of the standby mode for ventilators. According to the American Association for Respiratory Care Clinical Practice Guideline from the August 1992 issue of Respiratory Care (http://www. rcjournal.com/cpgs/mvsccpg.html), MV-SC1.0 Procedure: Patient Ventilator Check, MV-SC 2.0 Description: A patient-Ventilator system check is a documented evaluation of a mechanical ventilator and of the patient's response to mechanical ventilatory support. MV-SC 2.3 All data relevant to the patient-ventilator system check must be recorded...and include observations indicative of the ventilator's operation at the time of the check. Observations should include...2.3.1 observation that the ventilator is turned on and that the patient circuit is securely attached. 2.3.2.2 OVP [operational verification procedure] should be performed at the bedside just prior to connection to the patient after the patient circuit has been changed or disassembled for any reason. MV-SC 4.0 Indications: ...In addition, a check should be performed 4.3 following any change in ventilator settings.

The facility's failure to ensure the resident environment remained free of accident hazards when Resident 1 's ventilator was left in standby mode after tracheostomy care presented an imminent danger to the patient and was a direct proximate cause of the death of the patient.