The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

PALOMAR HEALTH DOWNTOWN CAMPUS 555 EAST VALLEY PARKWAY ESCONDIDO, CA 92025 Sept. 27, 2012
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure patient safety in a safe setting, as there was no formalized process for investigating issues related to adverse patient incidents that either caused harm or had the potential to cause harm.

Findings:

During the course of multiple complaint investigations, the facility failed to conduct thorough investigations in response to the following adverse patient incidents:

1. Patient 307, a [AGE] year old male, who was seen in the facility's Emergency Department (ED) on 9/14/11 at approximately 2:03 p.m. According to the ED notes, Patient 307 presented with signs and symptoms that were consistent with an alcohol withdrawal syndrome. The notes indicated Patient 307 had a generalized tonic clonic seizure (generalized seizure affecting the entire brain), lasting approximately 2 minutes, while waiting for evaluation in the ED, and another seizure while still in the ED. Patient 307's Significant Other reported multiple falls at home, and the ED physician noted Patient 307 had multiple resolving ecchymosis (bruising) on his arms and legs. The notes indicated Patient 307's last alcoholic drink was the day prior, on 9/13/11. The ED physician ordered a CT scan of the brain (imaging studies of the brain) prior to Patient 307 being admitted to the 7th floor. The reason for the CT, according to the ED notes, was for an altered level of consciousness. The CT done in the ED was normal, according to the radiologists report.

Patient 307 was admitted to the IMC on the 7 7th floor, on 9/14/11 at approximately 8:00 p.m., according to the nursing documentation. Observation of the 7th floor determined the room Patient 307 was placed in, was not visible from the nursing station. The admitting physician's history and physical (H&P) was reviewed on 12/7/11. According to the H&P, Patient 307 had new seizures related to alcohol withdrawal and a diagnosis of [DIAGNOSES REDACTED]

The Physician ordered seizure and fall precautions, as well as Clinical Institute Withdrawal Assessment (CIWA) protocol.

The CIWA protocol was reviewed with Administrative Staff on 12/7/11. According to Administrative Staff, the facility utilized a CIWA protocol order set entitled, Alcohol Withdrawal Order Set. According to the order set, nursing staff are to:

1. Assess and record the CIWA scores every four hours for a minimum of 13 total assessments (48 hours of initial assessment). Built into the order set are parameters for notification of the physician. According to the order set, the physician should be notified for:
2. An elevated blood pressure (systolic over 160).
3. A heart rate greater than 100. In Patient 307's case, the physician changed the perimeter to be notified for a heart rate greater than 120.
4. Another of the perimeters for physician notification was a CIWA score greater than 15. According to Administrative Staff, the reason for notification of the physician of CIWA scores greater than 15 was because once a patient's score was greater than 15 it meant, "The patient is too much to handle in IMC and needs to be transferred to ICU."

Registered Nurse (RN) 2, the first nurse to care for Patient 307 on the day of admission and again the following day (9/14/11 and 9/15/11 from 7 a.m. to 7 p.m.), was interviewed on 12/7/11 at 10:00 a.m. According to RN 2, Patient 307 was "really confused" and "out of it." He recalled the patient was "impulsive" and "wouldn't listen." RN 2 stated the patient had been found out of bed in the bathroom holding his tab alarm. (Tab alarm is a device connected to the patient's clothing and to the bed, so that when the patient gets out of bed, the alarm becomes detached and emits a loud noise.) RN 2 stated that Patient 307 took the entire tab alarm unit with him, so that the alarm would not disconnect from his person and therefore, no alarm would sound. RN 2 stated he found Patient 307 with his legs up over the rails of the bed and found him several times trying to get out of the bed. RN 2 did not recall if the bed alarms were on (bed alarms sound when the patient gets out of bed). According to RN 2 he told the charge nurse (CN X) that Patient 307 should be on a one-to-one (1:1) status (one nurse or a sitter to one patient for constant observation). RN 2 stated the Charge Nurse said she would see what she could do. RN 2 stated he warned the oncoming nurse (RN 3) to keep an eye on Patient 307.

According to the clinical record Patient 307 was not placed on a 1:1 status.

RN 3, the nurse caring for Patient 307 on 9/15/11 and 9/16/11 from 7:00 a.m. to 7:00 p.m., was interviewed on 11/10/11 at 11:00 a.m. and again on 12/7/11 at 5:30 p.m. RN 3 stated that Patient 307 was "impulsive" and "would get out of bed" and "would not follow directions." The staff continually reminded Patient 307 to ask for help before getting out of bed, but he wouldn't. RN 3 recalled the bed alarms were not in use, but didn't know why. According to RN 3, she had just been in the room prior to Patient 307 falling and had told him to stay in bed. A review of RN 3's documentation indicated one CIWA assessment was recorded on the morning of 9/16/11 at 8:00 a.m. The 12:00 p.m. and 4:00 p.m. CIWA assessments, prior to the fall, were missing.

RN 1, the nurse caring for Patient 307 on 9/16/11 from 7:00 p.m. to 7:00 a.m., was interviewed on 9/28/11 at 12:00 p.m. and 12/7/11 at 11:45 a.m. RN 1 recalled Patient 307 had a tab alarm on, but no bed alarms. According to RN 1, just prior to the fall, Patient 307 showed RN 1 that Patient 307 knew how to take the bed alarm off without the alarm sounding. RN 1 stated that Patient 307 said, "It's like the old car alarms," and proceeded to take the tab alarm off without it sounding and then put it back on. RN 1 stated he felt that Patient 307 should have been on a 1:1. RN 1 stated that after Patient 307 demonstrated he could remove the alarm without it sounding, RN 1 and RN 3 continued on to the next room for bedside report. After they left the room, they heard a "thud" coming from Patient 307's room. When they entered the room, Patient 307 was laying on the floor with his alarm in hand, still not sounding. Patient 307 was bleeding from his head and his nose.

Nursing staff notified the on-call physician and received orders for a CT scan of the head. According to the radiologists report, the CT Scan following the fall, showed a 2 cm acute right subdural hematoma (a collection of blood on the surface of the brain) and a 3 millimeter (mm) midline shift. (A shift of the brain, past its center line, is considered ominous, because it is commonly associated with a distortion of the [DIAGNOSES REDACTED] that can cause serious dysfunction, evidenced by abnormal posturing and failure of the pupils to constrict in response to light.)

The on-call physician (Physician Y) was notified of the results of the CT scan and ordered neurological signs every hour for 6 hours and then every 4 hours.

Following the fall, on the evening of 9/16/11, RN 1 documented CIWA assessments of 16 at 11:00 p.m. and 17 at 1:00 a.m. When questioned as to the significance of the elevated scores, RN 1 stated he knew he should have notified the physician, but he did not.

At 3:36 a.m., the Monitor Technician took a rhythm strip of Patient A's heart rate, as she noted an increased heart rate of 138. Again at 3:40 a.m., another strip was recorded due to a heart rate of greater than 154. Both strips were initialed by RN 1. RN 1 acknowledged his initials on the rhythm strips.

RN 1 was questioned again as to why he didn't further assess Patient 307 or notify the physician, as the order was to notify the physician with a heart rate greater than 120. RN 1 acknowledged that with the elevated heart rate, further assessment was warranted, at least a full set of vital signs. He could not answer why he did not further assess Patient 307. RN 1 acknowledged he did not notify the physician. RN 1 stated he thought Patient 307 was, "Just anxious."

RN 1 was questioned as to why he medicated Patient 307 with Ativan for anxiety at 11:27 p.m. and 1:26 a.m., but didn't medicate Patient 307 for what RN 1 perceived as anxiety at 3:40 a.m. RN 1 stated, "I thought the anxiety would go away." RN 1 documented that he placed Patient 307 on oxygen at 4:00 a.m.

According to the physician's orders, oxygen was to be used to maintain oxygen saturation levels to greater than 92%. RN 1 was asked why he found the need to place Patient 307 on oxygen at 4:00 a.m., as the recorded oxygen saturation at that time was 96%. According to RN 1, he did not recall placing the patient on oxygen, although he did acknowledge documenting the administration of oxygen in Patient 307's medical record at 4:00 a.m.

On 9/17/11 at 5:38 a.m., approximately 10 hours following Patient 307's fall, the phlebotomist (P1) came to the 7th floor for her routine blood draws. (P1) was interviewed on 9/29/11 at 10:30 a.m. and 11/18/11 at 4:00 a.m. According to P1, she drew Patient 307's blood the day before and he was "cranky and bitchy," but on the morning of 9/17/11 she was unable to arouse him. She stated the patient seemed "drugged," and "snoring in a deep sleep." She said, "I couldn't wake him up." P1 recalled a nurse outside the room. P1 stated the nurse must have heard her yelling to wake the patient up and P1 said, "I assumed the nurse told someone."

On the morning of 9/17/11 at 6:00 a.m., RN 1 found Patient 307 unresponsive, with a documented Glasgow Coma Scale (GCS) score of 3, on a scale of 3-15. (Glasgow Coma Scale is a neurological scale that aims to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessments). Three on the GCS indicates the patient does not open his eyes, is unable to make any verbal response or movement, and is in a deep unconsciousness.

RN 1 stated Patient 307 had no voluntary movement, even to a deep sternal rub. (A deep sternal rub is a forceful rub to the sternum (breast bone) to elicit a response from the patient.) RN 1 stated Patient 307's pupils were non-reactive (no reaction when a light is passed over the pupils). RN 1 stated he asked the Resource Nurse to "validate" his findings regarding the unconscious state of Patient 307. According to RN 1, the Resource Nurse had the same observations as RN 1. RN 1 stated he notified the on-call physician, Physician G, who was, "Sitting on the nurse's station." According to RN 1, he reported to Physician G that Patient 307 was " non-responsive," but Physician G stated he was off duty and told RN 1 to notify the oncoming physician, Physician L.

RN 1 stated he then called Patient 307's physician, Physician L, and waited for Physician L to arrive. When Physician L arrived, he initiated notification of the RRT (Rapid Response Team - a team of multidisciplinary staff most frequently consisting of ICU (Intensive Care Unit) trained personnel, who are available 24 hours per day, 7 days per week for evaluation of patients who develop signs or symptoms of [DIAGNOSES REDACTED].

Physician G was interviewed by phone on 12/27/11 at 3:20 p.m. According to Physician G, he was on shift from 10:00 p.m. to 6:00 a.m. Physician G stated Physician Y did not report off to him that Patient 307 had fallen. According to Physician G, the first time he heard about a fall or any problem with Patient A was after Physician L came on shift at 6:00 a.m. Physician G stated no one approached him at the nursing station regarding a patient in an unconscious state. Physician G stated he would not have told a nurse that he was "off duty" if there was an unconscious patient. He stated, "That's absurd."

The Respiratory Therapist (RT 1), working on the 7th floor, was the first RT to respond. RT 1 had no recall of the event. The second RT to respond (RT 2) was interviewed on 12/7/12 at 11:00 a.m. RT 2 stated she took over for RT 1 who was "bagging" (hand-held device used to provide positive pressure ventilation to a patient who is not breathing or who is breathing inadequately) the patient. RT 2 stated Patient 307 was non-responsive, comatose, and had a large bulge on his head that was covered with a bandage. Shortly thereafter, Patient 307 was intubated (breathing tube inserted for mechanical ventilation) by the ED physician. Then the Rapid Response Team arrived and hooked Patient 307 up to the monitors.

The Rapid Response Team Nurse (RRT 3), that responded on 9/17/11 at 6:35 a.m., was interviewed on 11/10/11 at 10:30 a.m. According to the RRT Nurse, whenever she responds to calls, she brings along a monitor and she hooks the patients up to the monitor. At the end of the call, she prints out a strip. The strip records ongoing vital signs and oxygen saturations. She then places the strip onto the RRT sheet, which she is responsible for filling out. RRT 3 pointed out the area on the RRT sheet where she attaches the strip. There was no strip attached to the RRT sheet. Neither the RRT, nor the Administrative Staff was able to explain why the printed strip was missing. RRT 3 stated she recalled that P1 (the phlebotomist) was the first to find Patient 307 unresponsive, when she entered the patient's room to draw the morning labs.

On 11/10/11 at 1:00 p.m., the Monitor Technician (MT) was interviewed regarding the recorded rhythm strips from 9/17/11 at 3:36 a.m. and 3:40 a.m. According to the MT, the facility documents rhythm strips in IMC every shift and with any changes in heart rhythm. The MT was questioned as to whether, after discovering a heart rate of 154, a rhythm strip would be obtained to indicate a change back to normal. The MT stated she would have done another strip indicating the change of rhythm back to normal. The MT could not explain what happened to the rhythm strip indicating a change after the elevated heart rate of 154. In fact, there were no documented strips in Patient 307's record from the 7th floor after the 3:40 a.m. strip, indicating a heart rate over 154.

The third CT Scan of Patient 307's brain was done on 9/17/11 at 7:45 a.m. The results were recorded as, "Marked increase in the right subdural hematoma ...measures 14 mm, compared to approximately 7 mm on previous examination (9/16/11 at 08:15 p.m.). There was an increase in the size of the midline shift and left ventricle. Interval development of left ventricular and fourth ventricular bleeding. New 2.7 cm left intraparenchymal bleeding centered over the left basal ganglia (essentially indicating the bleeding had expanded into the tissue and ventricles of the brain)."

A neurosurgical consultation was obtained on 9/17/11 at 9:13 a.m. According to the neurosurgeons dictated consultation, a phlebotomist found Patient 307 at 4:00 a.m., unresponsive. The neurosurgeons dictation indicated Patient 307 remained profoundly[DIAGNOSES REDACTED] (low platelet count, platelets assist with blood clotting) with increasing bleeding in the brain and noted, "Any prognosis for any meaningful recovery or survival is virtually nil ..."

A neurology consultation, obtained on 9/18/11 at 9:38 a.m., concurred with the neurosurgeon. The neurology consultation indicated Patient 307 had, "Hemorrhage in the pons of a fairly massive scale ...deeply comatose ...prognosis for any meaningful recovery is essentially zero ..."

Patient 307 continued to decline and the decision was made to change the level of care to Do Not Resuscitate (DNR) on 9/17/11 at 3:42 p.m. Patient 307 expired on [DATE] at 6:47 a.m. The coroner's report, dated 9/21/11, listed the cause of death as, "Complications of blunt force injury of head."

CDPH arrived at the facility on 9/22/11 at 9: 30 a.m., and met with the Chief Nursing Officer (CNO), who stated the Director of IMC did the investigation. Upon meeting with the Director of IMC, she stated the Manager did the investigation, who in turn stated the Interim Manager actually did the investigation, who in turn looked at the surveyor and stated, "I'm new at this, perhaps you (the Surveyor) can help me?" The Surveyor spoke briefly with the Chief of Quality to inquire who in the facility was actually responsible for the investigation, to which the Chief of Quality responded, "We do the RCA (root cause analysis), but we don't have anything to do with the investigation."

The Interim Manager stated she reviewed the record, "To ensure the RN did everything right." The Interim Manger admitted she was unaware of the elevation in Patient 307's heart rate over 154 at three in the morning, or the elevated CIWA scores, or the fact that RN 1 failed to call a rapid response team for assistance upon finding a patient with a GCS of 3.

The facility failed to sequester evidence. Although admitted ly, the facility had numerous problems with the alarms on the beds they were unable to ascertain which bed Patient 307 had been in. In addition, the cardiac monitoring history was gone from the machines memory. According to the onsite facility representative for the cardiac monitors, the facility maintains a 48 hour full disclosure recall except on discharged patients, and apparently this patient had been discharged from the floor. The facility was unable to produce any cardiac monitoring history. Administrative staff had no explanation as to the missing vital signs from RRT 3 or the rhythm strip establishing a change in HR following the 3:40 a.m. elevation of a heart rate over 154.

The facility had a policy entitled, Sentinel Event- Unusual Occurrence, which indicated the facility will, "Provide for security of any equipment or supplies that may be needed for future assessment of the situation...to collect information from individuals, chart forms, logs, etc. in order to create a complete chronology of events leading up to the incident,during the incident and following the incident as appropriate."

The investigation was limited to rectifying that the RN's actions were acceptable. The facility didn't provide any evidence that they had sequestered medical information or equipment which could have aided in creating a chronology of events that led to the incident. In fact the facility failed to show that any form of valuable investigation was done at all.

2. Patient 308 was admitted to an affiliated (sister) hospital (Hospital B) on 3/28/12. According to the Intensive Care Unit (ICU) Physician Discharge Summary dated 4/6/12, Patient 308 had, "A long standing history of psychiatric illness and multiple prior suicide attempts." The same H&P noted, "The patient was on a suicide watch, getting checked every 15 minutes. Between these frequent checks, the patient got a hold of a patient gown or a thin cloth that was used as a tie for the gown, tied it around her neck, tied it to a bar support in the bathroom, and lay down, creating essentially a hanging, choking sensation. She was found to be unresponsive and agonal. The code blue was called. She was ambu'd and required jaw thrust in order to ventilate. She was a difficult intubation, but ultimately was intubated and brought to the intensive care unit."
On 4/7/12, according to the psychiatric history and physical (H&P), Patient 308 was transferred back into Hospital B's Geropsychiatric unit on a 5250 (14 day hold) and "Needed a 24 hour sitter. " The plan was to admit to the sister facility's (Hospital A) Mental Health Unit to, "Monitor for safety."
On 4/18/12, according to the Nursing Narrative Notes, Patient (308) was, "Received as a transfer from the Geropsychiatric Unit (Hospital B) at 1430 (2:30 p.m. to Hospital A's MHU) via stretcher and two escorts ...Per Nursing Supervisor, patient placed on 15 (minute) safety checks."
On 4/19/12 at 10:34 p.m., a code blue was called, according to the code blue sheet. Patient 308 was taken to the trauma resuscitative room at 10: 41 p.m. and at 10:43 patient 308 was pronounced dead in the emergency room .
The Nursing Narrative Notes, timed and dated at 4/19/12 4:42 a.m., were reviewed. According to the notes at 10:15 Patient 308 was, "Still in the bathroom and stated she was ok (door to bathroom closed)." At 10:30, "I did not see the (patient) in her room, so I opened the bathroom door and found the (patient) in a sitting (crouching) position in front of the sink, a hospital gown was tied around the soap dispenser above the sink, she did not respond to questions. I called for help and another nurse helped lift the patient up to release the tension, she was lowered to the floor and a code blue was called. CPR was initiated by an RN and when the Code team came to the unit she was transferred to the ER."

The 15-minute Patient Monitoring Log for Safety sheets were reviewed on 6/8/12. The 15-minute checks were not started until 4:45 p.m. on 4/18/12. The 30 minute rounds, done on all patients in the Mental Health Unit, were not started until 4:30 p.m. on 4/18/12, two hours after arrival to the unit.

Further review of the 30-minute round checks, done on all patients in the unit, in comparison with the 15-minute Safety Monitoring checks, indicated the two forms of observation didn't match up. On 4/18/12 at 6:30 p.m., 6:45 p.m. and 7:00 p.m., Patient 308 was noted on the 15-minute Safety Monitoring checks to be in her room awake, however on the 30-minute rounds sheet, Patient 308 was noted to be in the lounge at 6:30 and 7:00 p.m.

On 4/19/12 at 5:30 and 5:45 p.m., the 15-minute Safety Checks indicated Patient 308 was in her room awake, however the 30-minute Rounds indicated Patient 308 was in the dining room at 5:30 and in her room at 6:00 p.m. Both the 15 minute and 30 minute rounds were done by the same CNA.

On 9/25/12 at 6:00 a.m., the facility Mental Health Unit was toured. The Round Sheets and the 15-minute safety check sheets were reviewed. The sheets were incomplete for the previous 30-minute check and the previous 15-minute check. The CNA stated, "I'm late on my rounds."

On 9/27/12 at 11:30 a.m., the Mental Health Unit was entered with Administrative Staff and again the rounds weren't up to the current time. Administrative Staff called the CNA to offer an explanation to the Surveyor. According to the CNA, she was, "Waiting for the patients to come to the dining room."

On 6/19/12 at 2:35 p.m. and 9/25/12 at 6:30 a.m., several staff members in the Mental Health Unit were interviewed related to the policy and practice of patient gowns and their availability to patients in the mental health unit. According to all the staff members, including a Charge Nurse that's worked on the unit for over 8 years, the policy and practice was to keep the gowns locked up.

The Manager of the Mental Health Unit was interviewed on 6/19/12 at 2:45 p.m., and stated she believed Patient 308 may have simply walked into another patient's room and picked up a gown off a bed. The Manager further stated, "There is no policy about locking up the gowns." When questioned why her staff seem to believe the policy and practice was to lock up the gowns, she stated "the gowns are locked up because we keep them with other supplies that need to be locked up." The Manger acknowledged that the facility policy for rounds included, "Direct observation." The Manger acknowledged the staff failed to directly observe Patient 308 on, "The last round" (prior to finding Patient 308 hanging on the soap dispenser in the bathroom). According to the Manager, she thought a correction might be to change the policy so direct observation wasn't necessary in order to, "Preserve patient privacy."

On 9/26/12 at 11:00 a.m. and 9/27/12 at 4:00 p.m., Administrative and Quality Staff were interviewed related to concerns of investigations not being thorough or missing. The Quality Staff had already informed CDPH an RCA was never done on the initial attempt of Patient 308 to hang herself at Hospital B because, "She was discharged ." However, admitted ly the patient was discharged from Hospital B to Hospital A and the same Quality Team was responsible for Hospital A and Hospital B. The Chief of Quality stated, "In retrospect, we probably should have done an RCA on that one."

The concern was raised during that meeting that without thorough investigations of near miss or unusual occurrences the facility was failing to provide a safe environment for the patients it cared for and was missing an opportunity to avoid reoccurrence of the same events.

3. On 7/31/12, the facility self reported an event, which was witnessed by the media. According to the report to CDPH a patient (Patient 309) had been triaged and was waiting in the emergency room (ER) waiting room. The patient left the waiting room and was overheard saying he wanted to kill himself. According to the facility report, the patient was, "Prevented from falling and was not harmed."

On 8/1/12 at 9:00 a.m., CDPH entered the facility, to review the case above. The ER Management Staff was interviewed. According to the ER Manager, Patient 309 was there for "detox" from crystal methamphetamines. The Physician Assistant (PA) triaged the patient. There were no beds in the ER, so the patient was sent back to the waiting room. Patient 309 left the waiting room and went to the 6th floor and was heard threatening to jump. The ER Technician pulled the patient back before he jumped over the rail. ER Management Staff could not access the Electronic Medical Record (EMR). The Chief Nursing Officer (CNO) was notified of the facility's repeated difficulty accessing and printing the EMR.

The EMR was reviewed on 8/3/12. According to the ER SIGN IN SHEET, Patient 309 was there for, "Medical Clearance for sobering services (possible ingestion of "speed" in his trail mix." The patient was signed into registration at 7:12 p.m. with admitting diagnoses listed as, "Psychiatric."

According to the Registration Clerk, interviewed on 8/2/12 at 12:11 p.m., she received the diagnoses from the Triage Nurse. The primary triage assessment was done out front in the waiting area and timed at 7:22 p.m., according to the EMR. The focused assessment was started at 7:58 p.m.

The focused assessment was reviewed with the RN responsible 9 RN 1) on 8/17/12 at 1:00 p.m. The focused assessment included a psychiatric assessment entitled, ED Suicide Risk Screening, which included multiple questions in a check box format, the last of which is, "Suicide ideation/intent/plan or attempt." This was the only question not answered on the focused assessment at 7:58 p.m. According to RN 1, she stated she didn't fill out the last question because, "Right then the patient had to go to the bathroom." She stated she did ask, and the answer was no, but she must have been, "Side tracked," and didn't get back to filling that part out until 11:47 p.m., after the patient had already jumped from the stairwell. According to RN 1, she handed Patient 309 the empty urine container, since he had to urinate, and even recalled him, "Coming back up to the triage door later with the urine bottle."

The Security tapes from the ER were viewed with security several times on 8/16/12 and 8/28/12. Patient 309 was observed leaving the ER with an empty urine bottle from triage at 8:03 p.m., and never returned. The next video was seen from the angle of the 4th floor door at 8:53 p.m., where the local police department had arrived in response to a suicide attempt in the facility's stairwell.

The Physician's Assistant (PA) on duty in the ER that evening, was interviewed by phone on 8/28/12 at 11:38 a.m. According to the PA, the nurses were double triaging that evening. The PA stated she didn't do an exam on Patient 309. She said she may have spoken with him, but didn't get full clarification. The PA stated with any psychiatric patient, "We always ask if the patient is suicidal, and if he is, we would hold him in the internal waiting room and draw lab values." The PA couldn't recall if she had asked the patient if he was suicidal, but stated typically the RN does that.

The Depart Summary, containing a time logged event of triage, was reviewed. According to the Summary, Rapid Medical Evaluation (RME) was requested at 7:55 p.m. The completion time was blank. The H&P Intake was completed at 10:59 p.m. Lab was ordered at 8:01 p.m., canceled at 8:01 p.m., and then completed at 10:01 p.m.

The RN (RN 2) that found Patient 309 in the stairwell was interviewed by phone on 8/16/12 at 1:00 p.m. According to RN 2, she was off duty visiting her father who was a patient at the facility. RN 2 went to her office to grab some paperwork she needed to catch up on and on the way back down the stairwell, upon approaching the 6th floor, she saw someone standing in the stairwell. According to RN 2, Patient 309 was in the stairwell and didn't look right. She stated he looked, "Creepy," and was, "Glaring at me." RN 2 stated she was scared for herself and concerned for the patients. S he backed against the wall and asked him if he was ok. RN 2 recalled he told her, "No, if you want to know the truth, I think I'm gonna jump." According to RN 2, Patient 309 stated, "I've been seen at two hospitals and nobody will help me," and made references to, "Ending it all." RN 2 then stated she made Patient 309 promise not to move and she summoned help by calling the PBX operator. The next thing she saw was the ER Technician and a security officer, and she left.

The ER Technician (ERT 3) was interviewed on 9/4/12 at 3:00 p.m. According to ERT 3, he responded to the call from the PBX operator, saw Patient 309 in the stairwell, where the patient threatened, "Don't come any closer or I'll jump." ERT 3 stated, "We've had a lot of jumpers here, but he was doing it." According to ERT 3, Patient 309 had both legs over the rail and moved his arm up, and was looking down the middle on the stairwell. ERT 3 stated he knew that was, "My chance," and grabbed the patients arm. He stated the patient was hanging there in the stairwell until security and the local police arrived, who helped bring Patient 309 back over the rails to safety. According to ERT 3, Patient 309 then attempted to go under the rails to jump, and seemed, "Mad we saved him."

The Police Officer that responded to the call was interviewed on 8/10/12 at 2:00 p.m., He stated when he arrived in the ER parking lot, he saw a security guard and asked, "Where's the jumper," and recalled security didn't know.

The Security Office at the facility was visited on 8/16/12 at 1:00 p.m. and 8/28/12 at 2:30 p.m. The security reports from the incident were reviewed. The daily log indicated, "At approximately 2055 (8:55 p.m.) I was walking down the hall by the ER when (a police officer) flagged me down and asked where the "jumper" was? I told him I knew nothing about it because our phones weren't working. He said it was on the fourth floor stairwell. I took him there and met (another security officer) who was already there. (Security Officer A) told us the jumper was (in) the stairwell. (Patient 309) was on the stairs talking with (ER technician). As soon as (Patient 309) saw (police officer) he attempted to jump, (ER technician) grabbed him as well as the (police officer). I looked in on them and when I saw (Patient 309) I ran up the stairs to assist. We put him in handcuffs for all of our safety. We escorted him to the internal waiting room ..."

Security Officer A was interviewed on 8/16/12 at 1:00 p.m. Security Officer A confirmed the phones were not working correctly and felt fortunate that the police officer was taken to the correct fourth floor stairwell, as there are two fourth floor stairwells in the facility. Security Officer A confirmed Patient 309 had both legs over the railings and was hanging in the middle of the stairwell by one arm, that ERT 3 was holding.

Several Security Personnel were interviewed and stated they had been having ongoing problems with communication. In this case, one Officer stated he tried to call and notify other Security Members and he couldn't be heard. According to the Security Personnel, they've actually had to use their own personal cell phones at times. They've made several attempts at rectifying the situation with IT (information technology) with a long paper trail, but without positive outcome. Security Personnel stated the hospital was switching service, changing towers, and consequently, the security department was experiencing intermittent communication difficulties.

On 8/15/12 at 10:00 a.m., Admi
VIOLATION: CONTENT OF RECORD Tag No: A0458
Based on interview and record review, the hospital could not provide evidence that a medical history and physical examination was documented prior to surgery for 1 of 11 surgical medical records reviewed (108). This resulted in the potential for confusion when the record was reviewed for quality or other purposes.

Findings:

Medical Records were reviewed 9/25/2012 at 1:50 p.m. and 9/26/2012 at 9:00 a.m. The electronic medical record for Patient 108 was for a patient who underwent robotic surgery. There was a space at the bottom of the consent form where it was documented that the History and Physical exam (H&P) was updated, but no evidence of the original H&P within 30 days of surgery. The Director of Quality and Patient Safety reviewed the document and could not find an H&P. At the end of the record was a form from Health Information that the chart was missing a signed, "Conditions for Admission," indicating that the chart had been reviewed, yet no mention of the missing H&P.
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview and record review, the hospital's governing body was not effective at ensuring that the Quality Assurance and Performance Improvement (QAPI) program was performing its required functions. There was evidence that resources provided for QAPI were inadequate for the scope of services provided. There were serious omissions in the functioning of the program that resulted in substantial risk to patients and staff throughout the hospital.

Findings:

1. The Governing Body did not ensure the medical staff and other hospital staff were fully accountable for the quality of care provided to patients. Refer to A049.

2. The Governing Body had not developed, implemented and maintained an effective, ongoing, hospital wide, data-driven QAPI program. The QAPI program failed to focus on activities to improve health outcomes and prevent and reduce medical errors. Investigations into medical errors were sometimes lacking or insufficient to result in improvement in the processes leading to the errors. Refer to A263.

3. The Governing Body did not assume responsibility and accountability for ensuring adequate resources were allocated for measuring and assessing, improving and sustaining the hospital's performance and for reducing the risk to patients. Refer to A315.
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview and document review, the governing body could not ensure accountability of the medical staff for the quality of care provided to patients. Eight cases were uncovered in which sentinel events or other adverse events occurred that were not adequately investigated by the Quality Assurance and Performance Improvement (QAPI) program. Serious deficiencies in the process used by the program were identified. Communication between departments and committees within the QAPI program were held only sporadically, allowing major system issues to go unnoticed. This resulted in repeated adverse events occurring without proper investigation and a failure to use these events as opportunities for improvement. Ongoing problems with the emergency notification system for Code Blue and Code Trauma had not been addressed, even after repeated discussions with the department and continual complaints by the staff. This resulted in the potential for Code Blue and Code Trauma events to experience delays in the arrival of all needed support staff.

Findings:

1. The Quality Management Committee meeting minutes were reviewed on 9/25/12 at 10:35 a.m. The minutes for meetings held 6/13/12, 7/11/12 and 9/12/12 were inspected. Many items were discussed, such as Code Blue reports, critical care items, tissue review, and review of minutes from other committees. There was no evidence of a discussion of any adverse events, any ongoing investigations into these events, or any discussions of ongoing Root Cause Analyses (RCA). (RCA-is a method of problem solving that tries to identify the root causes of faults or problems that cause operating events. RCA practice tries to solve problems by attempting to identify and correct the root causes of events, as opposed to simply addressing their symptoms. By focusing correction on root causes, problem recurrence can be prevented.)

2. The minutes for the Patient Safety Committee were reviewed of 9/25/12 at 11:20 a.m. An Executive Summary from 1/9/12 discussed the results of 3 RCA's from October 2011 and December 2011. In March 2012, another Executive Summary was presented by the Director of Quality and Patient Safety. Again, overviews of statistics were presented, but no further investigations discussed since the previous Executive Summary in January 2012. There was a list of what were identified as important items for discussion to be brought up at the next meeting. The Quality Binder contained an agenda page for the April and May 2012 meetings. Both were stamped "postponed." The Director of Quality stated at that time that both she and the Medical Officer for Quality were on vacation. The 6/11/12 meeting was poorly attended and limited in discussion, with no mention of the action items from March 2012, or discussion of ongoing or recent events and investigations. The July and August 2012 meeting agendas were also stamped "postponed" in support of the move to the new facility.

3. The minutes for the meetings of the Board of Directors (governing body) were reviewed 9/25/12 at 11:50 a.m. The September 2011 minutes indicated a review of the Board Quality Committee (MQRC) review from 8/9/11. The 10/10/11 meeting minutes stated that the MQRC review was "tomorrow" and so was not yet available for review. The next minutes were for 12/12/11 and did not mention the review from October 2011. There was simply a report of Press/Ganey statistics (patient survey). The Agenda pages for July and August 2012 were stamped "cancelled." Therefore, the only mention of the Board of Directors reviewing the Quality information from MQRC was the September 2011 review of the August 2011 information. There was no indication of a complete discussion of MQRC data indicated in the minutes from September 2011 until September 2012.

4. The minutes for the BQRC were reviewed on 9/25/12 at 12:00 p.m. The 6/18/12 minutes went into some detail of the items being monitored, such as stroke measures and Emergency Department (ED) statistics, a patient safety update, and some other statistics. However, no data was presented, only a statement or two on each item of the trend. There was no information on a discussion of any adverse events or ongoing RCA's or investigations. Again, the July and August 2012 meetings were canceled.

5. The Chief of Quality was interviewed on 9/26/12 at 1:00 p.m. and stated that two of the Patient safety meetings (April and May of 2012) were canceled because both she and the Medical Director for Quality were on vacation. She was asked if the fact that the hospital was in the midst of a move to a new facility might have lessened the focus on the investigation of adverse events, and she responded "no." In a later statement, she stated that the April and May 2012 Patient Safety meetings were canceled due to vacations (as stated previously), but the July and August 2012 meeting were canceled due to the move. When asked about documentation of the investigations performed at the unit level for adverse events, she stated that the units could not keep any documentation for legal reasons.

6. On 9/26/12 at 2:50 p.m., the Director of Quality and Patient Safety brought several large boxes filled with paper Quality Review Reports (QRRs). It was clear to the survey team that there was no practical way to review these for completion.

The Director used her laptop to bring up a log of reported QRR's. A brief scan of the log revealed the case of a patient (116) who attempted suicide on 6/27/12. The entry date for the QRR was 8/10/12, six weeks after the adverse event. At first the Director did not know of the case. She then remembered being called by one of the Quality Nurses about the event, but thought she was referencing a previous attempted suicide by another patient. The call occurred in August 2012, when the QRR was entered into the system, six weeks after the event. For this reason, another investigation was not begun on this new case. Also, no explanation could be given for the six week delay between the event and the logging in of the QRR.

The Quality Nurse involved was interviewed later (see 9/27/12 at 2:55 p.m.) and stated that she never had feedback on cases reported to the Director, so she never knew there was no RCA on this case or that there had been a misidentification of the case.

The Director also stated that the Quality Nurses, who reviewed all of the QRR's and either accepted them, or passed them on, consisted of 2 nurses at the downtown campus, one nurse at the Poway facility who reviewed the QRRs only from that hospital, one at the new campus, and one open position at the new campus. The Director stated that the investigations had to be prioritized due to workload. The Director said she was expected to be called or emailed for cases involving possible harm.

7. A second case was seen on the log of a patient (117) who reportedly had a hip replacement and then a reopening of the surgery due to a fracture seen on x-ray. Again, the Director did not know of the case. Further investigation showed that a Quality Nurse had initialed the QRR as not needing further investigation, but no documentation of her findings. Review of the patient record showed that the case was reopened because the prosthesis was not a good fit, not because of a fracture. The Director explained that the nurses review most of the QRRs and initial if no further investigation was needed. However, they may not document their own review, or may document it minimally. In this particular case, the Surveyor had to follow the paper trail in the medical record anew since there was no documentation as to why the Quality Nurse initialed it as complete.
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8. Patient 310, a third case, involved a facility-reported event. An anonymous member of the Operating Room (OR) team for this patient's procedure, reported that a patient had gallbladder surgery, but was found to have already had the gallbladder removed prior to the surgery.

Patient 310 was admitted to the facility on [DATE] for laparoscopic cholecystectomy (removal of the gallbladder with a small surgical scope through a small incision into the abdomen). Surgeon B performed the procedure. When he advanced the scope into the region of the gallbladder, he discovered that there was no gallbladder.

Surgeon B discussed this case with the Physician Surveyor in the administration conference room on 9/25/12 at 10:50 a.m. He first saw the patient in his office. The patient had been sent by the primary physician, because of gallstones on the ultrasound. The ultrasound, which he described as recent, maybe 6 months old, but could not be more specific, showed a small, contracted gallbladder with small stones and a question of a lesion on the kidney. The kidney finding made him think of renal [DIAGNOSES REDACTED] (cancer), but this was not found to be true on CT scan. He obtained a medical history at that visit in his office. The patient presented with symptoms consistent with inflammation of the gallbladder. The patient thought she might have had her gallbladder out "years" ago, but was not sure. The only visible scar was a nonspecific periumbilical scar.

The thing that most drove the surgeon's thinking was the ultrasound that showed a gallbladder with stones. The report did not have any lack of clarity like "maybe" or "could be." It said, "Contracted gallbladder with stones." He obtained a CT scan to help clarify. The kidney just had a complex cyst that required no intervention at this time. The report said the patient, "May have had a cholecystectomy, correlate clinically." Surgeon B said that CT was not a good study for the biliary system (liver and gall bladder and their drainage ducts) and that the ultrasound was much more reliable.

At this point he stated he didn't know why everyone was making, "Such a big deal out of this." He stated that perhaps he should have made the surgical consent for a lap exploration because of the uncertainty. After the procedure, he confirmed that the name and all the information from the radiology company matched the patient. He surmised that the ultrasound may have visualized a large cystic duct (the duct of the gall bladder) stump with stones, not uncommon in a patient with a sluggish biliary system after removal of the gall bladder. This would have been small and covered over with other tissue during the laparoscopy. After surgery, the patient was disappointed that there was no answer as to the cause of her symptoms, but did not appear angry with him. The family also seemed understanding. He mentioned that the daughter works in a doctor's office (possibly the referring physician), and served as the interpreter and he felt that communication was good throughout the pre, intra and post-operative processes.

When asked whether anyone from Administration or the Quality Department had contacted him, he said he had received a call and told the whole story to someone, but he could not recall the name or title of that person.

The Director of Quality was present during the interview with Surgeon B. When Surgeon B left the room, she stated she was the one who had spoken to the doctor on the phone. She stated she had no record of the conversation, no log of the call, and performed no further investigation. The event was not sent for peer review or to any of the quality-related committees.

9. The fourth case was Patient 307, a [AGE] year old male, who was seen in the facility's Emergency Department (ED) on 9/14/11 at approximately 2:03 p.m. According to the ED notes, Patient 307 presented with signs and symptoms that were consistent with an alcohol withdrawal syndrome. The notes indicated Patient 307 had a generalized tonic clonic seizure (generalized seizure affecting the entire brain), lasting approximately 2 minutes, while waiting for evaluation in the ED, and another seizure while still in the ED. Patient 307's Significant Other reported multiple falls at home, and the ED physician noted Patient 307 had multiple resolving ecchymosis (bruising) on his arms and legs. The notes indicated Patient 307's last alcoholic drink was the day prior, on 9/13/11. The ED physician ordered a CT scan of the brain (imaging studies of the brain) prior to Patient 307 being admitted to the 7th floor. The reason for the CT, according to the ED notes, was for an altered level of consciousness. The CT done in the ED was normal, according to the radiologists report.

Patient 307 was admitted to the IMC on the 7 7th floor, on 9/14/11 at approximately 8:00 p.m., according to the nursing documentation. Observation of the 7th floor determined the room Patient 307 was placed in, was not visible from the nursing station. The admitting physician's history and physical (H&P) was reviewed on 12/7/11. According to the H&P, Patient 307 had new seizures related to alcohol withdrawal and a diagnosis of [DIAGNOSES REDACTED]

The Physician ordered seizure and fall precautions, as well as Clinical Institute Withdrawal Assessment (CIWA) protocol.

The CIWA protocol was reviewed with Administrative Staff on 12/7/11. According to Administrative Staff, the facility utilized a CIWA protocol order set entitled, Alcohol Withdrawal Order Set. According to the order set, nursing staff are to:

1. Assess and record the CIWA scores every four hours for a minimum of 13 total assessments (48 hours of initial assessment). Built into the order set are parameters for notification of the physician. According to the order set, the physician should be notified for:
2. An elevated blood pressure (systolic over 160).
3. A heart rate greater than 100. In Patient 307's case, the physician changed the perimeter to be notified for a heart rate greater than 120.
4. Another of the perimeters for physician notification was a CIWA score greater than 15. According to Administrative Staff, the reason for notification of the physician of CIWA scores greater than 15 was because once a patient's score was greater than 15 it meant, "The patient is too much to handle in IMC and needs to be transferred to ICU."

Registered Nurse (RN) 2, the first nurse to care for Patient 307 on the day of admission and again the following day (9/14/11 and 9/15/11 from 7 a.m. to 7 p.m.), was interviewed on 12/7/11 at 10:00 a.m. According to RN 2, Patient 307 was "really confused" and "out of it." He recalled the patient was "impulsive" and "wouldn't listen." RN 2 stated the patient had been found out of bed in the bathroom holding his tab alarm. (Tab alarm is a device connected to the patient's clothing and to the bed, so that when the patient gets out of bed, the alarm becomes detached and emits a loud noise.) RN 2 stated that Patient 307 took the entire tab alarm unit with him, so that the alarm would not disconnect from his person and therefore, no alarm would sound. RN 2 stated he found Patient 307 with his legs up over the rails of the bed and found him several times trying to get out of the bed. RN 2 did not recall if the bed alarms were on (bed alarms sound when the patient gets out of bed). According to RN 2 he told the charge nurse (CN X) that Patient 307 should be on a one-to-one (1:1) status (one nurse or a sitter to one patient for constant observation). RN 2 stated the Charge Nurse said she would see what she could do. RN 2 stated he warned the oncoming nurse (RN 3) to keep an eye on Patient 307.

According to the clinical record Patient 307 was not placed on a 1:1 status.

RN 3, the nurse caring for Patient 307 on 9/15/11 and 9/16/11 from 7:00 a.m. to 7:00 p.m., was interviewed on 11/10/11 at 11:00 a.m. and again on 12/7/11 at 5:30 p.m. RN 3 stated that Patient 307 was "impulsive" and "would get out of bed" and "would not follow directions." The staff continually reminded Patient 307 to ask for help before getting out of bed, but he wouldn't. RN 3 recalled the bed alarms were not in use, but didn't know why. According to RN 3, she had just been in the room prior to Patient 307 falling and had told him to stay in bed. A review of RN 3's documentation indicated one CIWA assessment was recorded on the morning of 9/16/11 at 8:00 a.m. The 12:00 p.m. and 4:00 p.m. CIWA assessments, prior to the fall, were missing.

RN 1, the nurse caring for Patient 307 on 9/16/11 from 7:00 p.m. to 7:00 a.m., was interviewed on 9/28/11 at 12:00 p.m. and 12/7/11 at 11:45 a.m. RN 1 recalled Patient 307 had a tab alarm on, but no bed alarms. According to RN 1, just prior to the fall, Patient 307 showed RN 1 that Patient 307 knew how to take the bed alarm off without the alarm sounding. RN 1 stated that Patient 307 said, "It's like the old car alarms," and proceeded to take the tab alarm off without it sounding and then put it back on. RN 1 stated he felt that Patient 307 should have been on a 1:1. RN 1 stated that after Patient 307 demonstrated he could remove the alarm without it sounding, RN 1 and RN 3 continued on to the next room for bedside report. After they left the room, they heard a "thud" coming from Patient 307's room. When they entered the room, Patient 307 was laying on the floor with his alarm in hand, still not sounding. Patient 307 was bleeding from his head and his nose.

Nursing staff notified the on-call physician and received orders for a CT scan of the head. According to the radiologists report, the CT Scan following the fall, showed a 2 cm acute right subdural hematoma (a collection of blood on the surface of the brain) and a 3 millimeter (mm) midline shift. (A shift of the brain, past its center line, is considered ominous, because it is commonly associated with a distortion of the [DIAGNOSES REDACTED] that can cause serious dysfunction, evidenced by abnormal posturing and failure of the pupils to constrict in response to light.)

The on-call physician (Physician Y) was notified of the results of the CT scan and ordered neurological signs every hour for 6 hours and then every 4 hours.

Following the fall, on the evening of 9/16/11, RN 1 documented CIWA assessments of 16 at 11:00 p.m. and 17 at 1:00 a.m. When questioned as to the significance of the elevated scores, RN 1 stated he knew he should have notified the physician, but he did not.

At 3:36 a.m., the Monitor Technician took a rhythm strip of Patient A's heart rate, as she noted an increased heart rate of 138. Again at 3:40 a.m., another strip was recorded due to a heart rate of greater than 154. Both strips were initialed by RN 1. RN 1 acknowledged his initials on the rhythm strips.

RN 1 was questioned again as to why he didn't further assess Patient 307 or notify the physician, as the order was to notify the physician with a heart rate greater than 120. RN 1 acknowledged that with the elevated heart rate, further assessment was warranted, at least a full set of vital signs. He could not answer why he did not further assess Patient 307. RN 1 acknowledged he did not notify the physician. RN 1 stated he thought Patient 307 was, "Just anxious."

RN 1 was questioned as to why he medicated Patient 307 with Ativan for anxiety at 11:27 p.m. and 1:26 a.m., but didn't medicate Patient 307 for what RN 1 perceived as anxiety at 3:40 a.m. RN 1 stated, "I thought the anxiety would go away." RN 1 documented that he placed Patient 307 on oxygen at 4:00 a.m.

According to the physician's orders, oxygen was to be used to maintain oxygen saturation levels to greater than 92%. RN 1 was asked why he found the need to place Patient 307 on oxygen at 4:00 a.m., as the recorded oxygen saturation at that time was 96%. According to RN 1, he did not recall placing the patient on oxygen, although he did acknowledge documenting the administration of oxygen in Patient 307's medical record at 4:00 a.m.

On 9/17/11 at 5:38 a.m., approximately 10 hours following Patient 307's fall, the phlebotomist (P1) came to the 7th floor for her routine blood draws. (P1) was interviewed on 9/29/11 at 10:30 a.m. and 11/18/11 at 4:00 a.m. According to P1, she drew Patient 307's blood the day before and he was "cranky and bitchy," but on the morning of 9/17/11 she was unable to arouse him. She stated the patient seemed "drugged," and "snoring in a deep sleep." She said, "I couldn't wake him up." P1 recalled a nurse outside the room. P1 stated the nurse must have heard her yelling to wake the patient up and P1 said, "I assumed the nurse told someone."

On the morning of 9/17/11 at 6:00 a.m., RN 1 found Patient 307 unresponsive, with a documented Glasgow Coma Scale (GCS) score of 3, on a scale of 3-15. (Glasgow Coma Scale is a neurological scale that aims to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessments). Three on the GCS indicates the patient does not open his eyes, is unable to make any verbal response or movement, and is in a deep unconsciousness.

RN 1 stated Patient 307 had no voluntary movement, even to a deep sternal rub. (A deep sternal rub is a forceful rub to the sternum (breast bone) to elicit a response from the patient.) RN 1 stated Patient 307's pupils were non-reactive (no reaction when a light is passed over the pupils). RN 1 stated he asked the Resource Nurse to "validate" his findings regarding the unconscious state of Patient 307. According to RN 1, the Resource Nurse had the same observations as RN 1. RN 1 stated he notified the on-call physician, Physician G, who was, "Sitting on the nurse's station." According to RN 1, he reported to Physician G that Patient 307 was " non-responsive," but Physician G stated he was off duty and told RN 1 to notify the oncoming physician, Physician L.

RN 1 stated he then called Patient 307's physician, Physician L, and waited for Physician L to arrive. When Physician L arrived, he initiated notification of the RRT (Rapid Response Team - a team of multidisciplinary staff most frequently consisting of ICU (Intensive Care Unit) trained personnel, who are available 24 hours per day, 7 days per week for evaluation of patients who develop signs or symptoms of [DIAGNOSES REDACTED].

Physician G was interviewed by phone on 12/27/11 at 3:20 p.m. According to Physician G, he was on shift from 10:00 p.m. to 6:00 a.m. Physician G stated Physician Y did not report off to him that Patient 307 had fallen. According to Physician G, the first time he heard about a fall or any problem with Patient A was after Physician L came on shift at 6:00 a.m. Physician G stated no one approached him at the nursing station regarding a patient in an unconscious state. Physician G stated he would not have told a nurse that he was "off duty" if there was an unconscious patient. He stated, "That's absurd."

The Respiratory Therapist (RT 1), working on the 7th floor, was the first RT to respond. RT 1 had no recall of the event. The second RT to respond (RT 2) was interviewed on 12/7/12 at 11:00 a.m. RT 2 stated she took over for RT 1 who was "bagging" (hand-held device used to provide positive pressure ventilation to a patient who is not breathing or who is breathing inadequately) the patient. RT 2 stated Patient 307 was non-responsive, comatose, and had a large bulge on his head that was covered with a bandage. Shortly thereafter, Patient 307 was intubated (breathing tube inserted for mechanical ventilation) by the ED physician. Then the Rapid Response Team arrived and hooked Patient 307 up to the monitors.

The Rapid Response Team Nurse (RRT 3), that responded on 9/17/11 at 6:35 a.m., was interviewed on 11/10/11 at 10:30 a.m. According to the RRT Nurse, whenever she responds to calls, she brings along a monitor and she hooks the patients up to the monitor. At the end of the call, she prints out a strip. The strip records ongoing vital signs and oxygen saturations. She then places the strip onto the RRT sheet, which she is responsible for filling out. RRT 3 pointed out the area on the RRT sheet where she attaches the strip. There was no strip attached to the RRT sheet. Neither the RRT, nor the Administrative Staff was able to explain why the printed strip was missing. RRT 3 stated she recalled that P1 (the phlebotomist) was the first to find Patient 307 unresponsive, when she entered the patient's room to draw the morning labs.

On 11/10/11 at 1:00 p.m., the Monitor Technician (MT) was interviewed regarding the recorded rhythm strips from 9/17/11 at 3:36 a.m. and 3:40 a.m. According to the MT, the facility documents rhythm strips in IMC every shift and with any changes in heart rhythm. The MT was questioned as to whether, after discovering a heart rate of 154, a rhythm strip would be obtained to indicate a change back to normal. The MT stated she would have done another strip indicating the change of rhythm back to normal. The MT could not explain what happened to the rhythm strip indicating a change after the elevated heart rate of 154. In fact, there were no documented strips in Patient 307's record from the 7th floor after the 3:40 a.m. strip, indicating a heart rate over 154.

The third CT Scan of Patient 307's brain was done on 9/17/11 at 7:45 a.m. The results were recorded as, "Marked increase in the right subdural hematoma ...measures 14 mm, compared to approximately 7 mm on previous examination (9/16/11 at 08:15 p.m.). There was an increase in the size of the midline shift and left ventricle. Interval development of left ventricular and fourth ventricular bleeding. New 2.7 cm left intraparenchymal bleeding centered over the left basal ganglia (essentially indicating the bleeding had expanded into the tissue and ventricles of the brain)."

A neurosurgical consultation was obtained on 9/17/11 at 9:13 a.m. According to the neurosurgeons dictated consultation, a phlebotomist found Patient 307 at 4:00 a.m., unresponsive. The neurosurgeons dictation indicated Patient 307 remained profoundly[DIAGNOSES REDACTED] (low platelet count, platelets assist with blood clotting) with increasing bleeding in the brain and noted, "Any prognosis for any meaningful recovery or survival is virtually nil ..."

A neurology consultation, obtained on 9/18/11 at 9:38 a.m., concurred with the neurosurgeon. The neurology consultation indicated Patient 307 had, "Hemorrhage in the pons of a fairly massive scale ...deeply comatose ...prognosis for any meaningful recovery is essentially zero ..."

Patient 307 continued to decline and the decision was made to change the level of care to Do Not Resuscitate (DNR) on 9/17/11 at 3:42 p.m. Patient 307 expired on [DATE] at 6:47 a.m. The coroner's report, dated 9/21/11, listed the cause of death as, "Complications of blunt force injury of head."

CDPH arrived at the facility on 9/22/11 at 9: 30 a.m., and met with the Chief Nursing Officer (CNO), who stated the Director of IMC did the investigation. Upon meeting with the Director of IMC, she stated the Manager did the investigation, who in turn stated the Interim Manager actually did the investigation, who in turn looked at the surveyor and stated, "I'm new at this, perhaps you (the Surveyor) can help me?" The Surveyor spoke briefly with the Chief of Quality to inquire who in the facility was actually responsible for the investigation, to which the Chief of Quality responded, "We do the RCA (root cause analysis), but we don't have anything to do with the investigation."

The Interim Manager stated she reviewed the record, "To ensure the RN did everything right." The Interim Manger admitted she was unaware of the elevation in Patient 307's heart rate over 154 at three in the morning, or the elevated CIWA scores, or the fact that RN 1 failed to call a rapid response team for assistance upon finding a patient with a GCS of 3.

The facility failed to sequester evidence. Although admitted ly, the facility had numerous problems with the alarms on the beds they were unable to ascertain which bed Patient 307 had been in. In addition, the cardiac monitoring history was gone from the machines memory. According to the onsite facility representative for the cardiac monitors, the facility maintains a 48 hour full disclosure recall except on discharged patients, and apparently this patient had been discharged from the floor. The facility was unable to produce any cardiac monitoring history. Administrative staff had no explanation as to the missing vital signs from RRT 3 or the rhythm strip establishing a change in HR following the 3:40 a.m. elevation of a heart rate over 154.

The facility had a policy entitled, Sentinel Event- Unusual Occurrence, which indicated the facility will, "Provide for security of any equipment or supplies that may be needed for future assessment of the situation...to collect information from individuals, chart forms, logs, etc. in order to create a complete chronology of events leading up to the incident,during the incident and following the incident as appropriate."

The investigation was limited to rectifying that the RN's actions were acceptable. The facility didn't provide any evidence that they had sequestered medical information or equipment which could have aided in creating a chronology of events that led to the incident. In fact the facility failed to show that any form of valuable investigation was done at all.


10. Patient 308, the fifth case, was admitted to an affiliated (sister) hospital (Hospital B) on 3/28/12. According to the Intensive Care Unit (ICU) Physician Discharge Summary dated 4/6/12, Patient 308 had, "A long standing history of psychiatric illness and multiple prior suicide attempts." The same H&P noted, "The patient was on a suicide watch, getting checked every 15 minutes. Between these frequent checks, the patient got a hold of a patient gown or a thin cloth that was used as a tie for the gown, tied it around her neck, tied it to a bar support in the bathroom, and lay down, creating essentially a hanging, choking sensation. She was found to be unresponsive and agonal. The code blue was called. She was ambu'd and required jaw thrust in order to ventilate. She was a difficult intubation, but ultimately was intubated and brought to the intensive care unit."
On 4/7/12, according to the psychiatric history and physical (H&P), Patient 308 was transferred back into Hospital B's Geropsychiatric unit on a 5250 (14 day hold) and "Needed a 24 hour sitter. " The plan was to admit to the sister facility's (Hospital A) Mental Health Unit to, "Monitor for safety."
On 4/18/12, according to the Nursing Narrative Notes, Patient (308) was, "Received as a transfer from the Geropsychiatric Unit (Hospital B) at 1430 (2:30 p.m. to Hospital A's MHU) via stretcher and two escorts ...Per Nursing Supervisor, patient placed on 15 (minute) safety checks."
On 4/19/12 at 10:34 p.m., a code blue was called, according to the code blue sheet. Patient 308 was taken to the trauma resuscitative room at 10: 41 p.m. and at 10:43 patient 308 was pronounced dead in the emergency room .
The Nursing Narrative Notes, timed and dated at 4/19/12 4:42 a.m., were reviewed. According to the notes at 10:15 Patient 308 was, "Still in the bathroom and stated she was ok (door to bathroom closed)." At 10:30, "I did not see the (patient) in her room, so I opened the bathroom door and found the (patient) in a sitting (crouching) position in front of the sink, a hospital gown was tied around the soap dispenser above the sink, she did not respond to questions. I called for help and another nurse helped lift the patient up to release the tension, she was lowered to the floor and a code blue was called. CPR was initiated by an RN and when the Code team came to the unit she was transferred to the ER."

The 15-minute Patient Monitoring Log for Safety sheets were reviewed on 6/8/12. The 15-minute checks were not started until 4:45 p.m. on 4/18/12. The 30 minute rounds, done on all patients in the Mental Health Unit, were not started until 4:30 p.m. on 4/18/12, two hours after arrival to the unit.

Further review of the 30-minute round checks, done on all patients in the unit, in comparison with the 15-minute Safety Monitoring checks, indicated the two forms of observation didn't match up. On 4/18/12 at 6:30 p.m., 6:45 p.m. and 7:00 p.m., Patient 308 was noted on the 15-minute Safety Monitoring checks to be in her room awake, however on the 30-minute rounds sheet, Patient 308 was noted to be in the lounge at 6:30 and 7:00 p.m.

On 4/19/12 at 5:30 and 5:45 p.m., the 15-minute Safety Checks indicat
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on interviews and patient record review, the facility failed to follow their process or demonstrate a clear knowledge of what the process was for investigation of adverse patient incidents in the facility.

Findings:

The facility did not ensure adverse patient events/incidents were investigated to improve quality care and safe patient outcomes. Refer to A144.
VIOLATION: QAPI Tag No: A0263
Based on observation, interview and record review, the hospital's Quality Assurance and Performance Improvement (QAPI) program was not effective in identifying significant adverse events, investigating these events, and identifying performance improvement measures to deal with such events in the future. Eight cases were uncovered in which sentinel events or other adverse events occurred that were not adequately investigated by the QAPI program. Serious deficiencies in the process used by the program were identified. Communication between departments and committees within the QAPI program were held only sporadically, allowing major system issues to go unnoticed. This resulted in repeated adverse events occurring without proper investigation and a failure to use these events as opportunities for improvement. Ongoing problems with the emergency notification system for Code Blue and Code Trauma had not been addressed, even after repeated discussions with the department and continual complaints by the staff.

Findings:


1. The QAPI program did not identify and reduce medical errors in nine cases of adverse events that were not properly investigated. In addition, the structure of the reporting and investigation systems made it likely that many other cases were also undergoing inadequate investigation, resulting in a failure to undertake performance improvement measures to prevent similar errors in the future. Refer to A266.

2. The program did not incorporate patient care data for the nine identified cases into the QAPI program. Therefore, the hospital did not use the data to monitor the effectiveness and safety of services and quality of care. The hospital could not use the poorly collected and identified data to identify opportunities for improvement and changes that will lead to improvement in the quality of care. Refer to A273.

3. The hospitals performance improvement activities did not track medical errors and adverse patient events, analyze their causes, and and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. Refer to A286.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the Quality Assurance and Performance Improvement (QAPI) program did not incorporate patient care data on eight adverse events resulting in an inability to monitor the effectiveness and safety of care and to identify opportunities for improvement and changes that will lead to improvement.


Findings:

1. On 9/26/12 at 2:50 p.m., the Director of Quality and Patient Safety brought several large boxes filled with paper Quality Review Reports (QRRs). It was clear to the survey team that there was no practical way to review these for completion.

The Director used her laptop to bring up a log of reported QRR's. A brief scan of the log revealed the case of a patient (116) who attempted suicide on 6/27/12. The entry date for the QRR was 8/10/12, six weeks after the adverse event. At first the Director did not know of the case. She then remembered being called by one of the Quality Nurses about the event, but thought she was referencing a previous attempted suicide by another patient. The call occurred in August 2012, when the QRR was entered into the system, six weeks after the event. For this reason, another investigation was not begun on this new case. Also, no explanation could be given for the six week delay between the event and the logging in of the QRR.

The Quality Nurse involved was interviewed later (see 9/27/12 at 2:55 p.m.) and stated that she never had feedback on cases reported to the Director, so she never knew there was no RCA on this case or that there had been a misidentification of the case.

The Director also stated that the Quality Nurses, who reviewed all of the QRR's and either accepted them, or passed them on, consisted of 2 nurses at the downtown campus, one nurse at the Poway facility who reviewed the QRRs only from that hospital, one at the new campus, and one open position at the new campus. The Director stated that the investigations had to be prioritized due to workload. The Director said she was expected to be called or emailed for cases involving possible harm.

2. A second case was seen on the log of a patient (117) who reportedly had a hip replacement and then a reopening of the surgery due to a fracture seen on x-ray. Again, the Director did not know of the case. Further investigation showed that a Quality Nurse had initialed the QRR as not needing further investigation, but no documentation of her findings. Review of the patient record showed that the case was reopened because the prosthesis was not a good fit, not because of a fracture. The Director explained that the nurses review most of the QRRs and initial if no further investigation was needed. However, they may not document their own review, or may document it minimally. In this particular case, the Surveyor had to follow the paper trail in the medical record anew since there was no documentation as to why the Quality Nurse initialed it as complete.
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3. Patient 310, a third case, involved a facility-reported event. An anonymous member of the Operating Room (OR) team for this patient's procedure, reported that a patient had gallbladder surgery, but was found to have already had the gallbladder removed prior to the surgery.

Patient 310 was admitted to the facility on [DATE] for laparoscopic cholecystectomy (removal of the gallbladder with a small surgical scope through a small incision into the abdomen). Surgeon B performed the procedure. When he advanced the scope into the region of the gallbladder, he discovered that there was no gallbladder.

Surgeon B discussed this case with the Physician Surveyor in the administration conference room on 9/25/12 at 10:50 a.m. He first saw the patient in his office. The patient had been sent by the primary physician, because of gallstones on the ultrasound. The ultrasound, which he described as recent, maybe 6 months old, but could not be more specific, showed a small, contracted gallbladder with small stones and a question of a lesion on the kidney. The kidney finding made him think of renal [DIAGNOSES REDACTED] (cancer), but this was not found to be true on CT scan. He obtained a medical history at that visit in his office. The patient presented with symptoms consistent with inflammation of the gallbladder. The patient thought she might have had her gallbladder out "years" ago, but was not sure. The only visible scar was a nonspecific periumbilical scar.

The thing that most drove the surgeon's thinking was the ultrasound that showed a gallbladder with stones. The report did not have any lack of clarity like "maybe" or "could be." It said, "Contracted gallbladder with stones." He obtained a CT scan to help clarify. The kidney just had a complex cyst that required no intervention at this time. The report said the patient, "May have had a cholecystectomy, correlate clinically." Surgeon B said that CT was not a good study for the biliary system (liver and gall bladder and their drainage ducts) and that the ultrasound was much more reliable.

At this point he stated he didn't know why everyone was making, "Such a big deal out of this." He stated that perhaps he should have made the surgical consent for a lap exploration because of the uncertainty. After the procedure, he confirmed that the name and all the information from the radiology company matched the patient. He surmised that the ultrasound may have visualized a large cystic duct (the duct of the gall bladder) stump with stones, not uncommon in a patient with a sluggish biliary system after removal of the gall bladder. This would have been small and covered over with other tissue during the laparoscopy. After surgery, the patient was disappointed that there was no answer as to the cause of her symptoms, but did not appear angry with him. The family also seemed understanding. He mentioned that the daughter works in a doctor's office (possibly the referring physician), and served as the interpreter and he felt that communication was good throughout the pre, intra and post-operative processes.

When asked whether anyone from Administration or the Quality Department had contacted him, he said he had received a call and told the whole story to someone, but he could not recall the name or title of that person.

The Director of Quality was present during the interview with Surgeon B. When Surgeon B left the room, she stated she was the one who had spoken to the doctor on the phone. She stated she had no record of the conversation, no log of the call, and performed no further investigation. The event was not sent for peer review or to any of the quality-related committees.

4. The fourth case was Patient 307, a [AGE] year old male, who was seen in the facility's Emergency Department (ED) on 9/14/11 at approximately 2:03 p.m. According to the ED notes, Patient 307 presented with signs and symptoms that were consistent with an alcohol withdrawal syndrome. The notes indicated Patient 307 had a generalized tonic clonic seizure (generalized seizure affecting the entire brain), lasting approximately 2 minutes, while waiting for evaluation in the ED, and another seizure while still in the ED. Patient 307's Significant Other reported multiple falls at home, and the ED physician noted Patient 307 had multiple resolving ecchymosis (bruising) on his arms and legs. The notes indicated Patient 307's last alcoholic drink was the day prior, on 9/13/11. The ED physician ordered a CT scan of the brain (imaging studies of the brain) prior to Patient 307 being admitted to the 7th floor. The reason for the CT, according to the ED notes, was for an altered level of consciousness. The CT done in the ED was normal, according to the radiologists report.

Patient 307 was admitted to the IMC on the 7 7th floor, on 9/14/11 at approximately 8:00 p.m., according to the nursing documentation. Observation of the 7th floor determined the room Patient 307 was placed in, was not visible from the nursing station. The admitting physician's history and physical (H&P) was reviewed on 12/7/11. According to the H&P, Patient 307 had new seizures related to alcohol withdrawal and a diagnosis of [DIAGNOSES REDACTED]

The Physician ordered seizure and fall precautions, as well as Clinical Institute Withdrawal Assessment (CIWA) protocol.

The CIWA protocol was reviewed with Administrative Staff on 12/7/11. According to Administrative Staff, the facility utilized a CIWA protocol order set entitled, Alcohol Withdrawal Order Set. According to the order set, nursing staff are to:

1. Assess and record the CIWA scores every four hours for a minimum of 13 total assessments (48 hours of initial assessment). Built into the order set are parameters for notification of the physician. According to the order set, the physician should be notified for:
2. An elevated blood pressure (systolic over 160).
3. A heart rate greater than 100. In Patient 307's case, the physician changed the perimeter to be notified for a heart rate greater than 120.
4. Another of the perimeters for physician notification was a CIWA score greater than 15. According to Administrative Staff, the reason for notification of the physician of CIWA scores greater than 15 was because once a patient's score was greater than 15 it meant, "The patient is too much to handle in IMC and needs to be transferred to ICU."

Registered Nurse (RN) 2, the first nurse to care for Patient 307 on the day of admission and again the following day (9/14/11 and 9/15/11 from 7 a.m. to 7 p.m.), was interviewed on 12/7/11 at 10:00 a.m. According to RN 2, Patient 307 was "really confused" and "out of it." He recalled the patient was "impulsive" and "wouldn't listen." RN 2 stated the patient had been found out of bed in the bathroom holding his tab alarm. (Tab alarm is a device connected to the patient's clothing and to the bed, so that when the patient gets out of bed, the alarm becomes detached and emits a loud noise.) RN 2 stated that Patient 307 took the entire tab alarm unit with him, so that the alarm would not disconnect from his person and therefore, no alarm would sound. RN 2 stated he found Patient 307 with his legs up over the rails of the bed and found him several times trying to get out of the bed. RN 2 did not recall if the bed alarms were on (bed alarms sound when the patient gets out of bed). According to RN 2 he told the charge nurse (CN X) that Patient 307 should be on a one-to-one (1:1) status (one nurse or a sitter to one patient for constant observation). RN 2 stated the Charge Nurse said she would see what she could do. RN 2 stated he warned the oncoming nurse (RN 3) to keep an eye on Patient 307.

According to the clinical record Patient 307 was not placed on a 1:1 status.

RN 3, the nurse caring for Patient 307 on 9/15/11 and 9/16/11 from 7:00 a.m. to 7:00 p.m., was interviewed on 11/10/11 at 11:00 a.m. and again on 12/7/11 at 5:30 p.m. RN 3 stated that Patient 307 was "impulsive" and "would get out of bed" and "would not follow directions." The staff continually reminded Patient 307 to ask for help before getting out of bed, but he wouldn't. RN 3 recalled the bed alarms were not in use, but didn't know why. According to RN 3, she had just been in the room prior to Patient 307 falling and had told him to stay in bed. A review of RN 3's documentation indicated one CIWA assessment was recorded on the morning of 9/16/11 at 8:00 a.m. The 12:00 p.m. and 4:00 p.m. CIWA assessments, prior to the fall, were missing.

RN 1, the nurse caring for Patient 307 on 9/16/11 from 7:00 p.m. to 7:00 a.m., was interviewed on 9/28/11 at 12:00 p.m. and 12/7/11 at 11:45 a.m. RN 1 recalled Patient 307 had a tab alarm on, but no bed alarms. According to RN 1, just prior to the fall, Patient 307 showed RN 1 that Patient 307 knew how to take the bed alarm off without the alarm sounding. RN 1 stated that Patient 307 said, "It's like the old car alarms," and proceeded to take the tab alarm off without it sounding and then put it back on. RN 1 stated he felt that Patient 307 should have been on a 1:1. RN 1 stated that after Patient 307 demonstrated he could remove the alarm without it sounding, RN 1 and RN 3 continued on to the next room for bedside report. After they left the room, they heard a "thud" coming from Patient 307's room. When they entered the room, Patient 307 was laying on the floor with his alarm in hand, still not sounding. Patient 307 was bleeding from his head and his nose.

Nursing staff notified the on-call physician and received orders for a CT scan of the head. According to the radiologists report, the CT Scan following the fall, showed a 2 cm acute right subdural hematoma (a collection of blood on the surface of the brain) and a 3 millimeter (mm) midline shift. (A shift of the brain, past its center line, is considered ominous, because it is commonly associated with a distortion of the [DIAGNOSES REDACTED] that can cause serious dysfunction, evidenced by abnormal posturing and failure of the pupils to constrict in response to light.)

The on-call physician (Physician Y) was notified of the results of the CT scan and ordered neurological signs every hour for 6 hours and then every 4 hours.

Following the fall, on the evening of 9/16/11, RN 1 documented CIWA assessments of 16 at 11:00 p.m. and 17 at 1:00 a.m. When questioned as to the significance of the elevated scores, RN 1 stated he knew he should have notified the physician, but he did not.

At 3:36 a.m., the Monitor Technician took a rhythm strip of Patient A's heart rate, as she noted an increased heart rate of 138. Again at 3:40 a.m., another strip was recorded due to a heart rate of greater than 154. Both strips were initialed by RN 1. RN 1 acknowledged his initials on the rhythm strips.

RN 1 was questioned again as to why he didn't further assess Patient 307 or notify the physician, as the order was to notify the physician with a heart rate greater than 120. RN 1 acknowledged that with the elevated heart rate, further assessment was warranted, at least a full set of vital signs. He could not answer why he did not further assess Patient 307. RN 1 acknowledged he did not notify the physician. RN 1 stated he thought Patient 307 was, "Just anxious."

RN 1 was questioned as to why he medicated Patient 307 with Ativan for anxiety at 11:27 p.m. and 1:26 a.m., but didn't medicate Patient 307 for what RN 1 perceived as anxiety at 3:40 a.m. RN 1 stated, "I thought the anxiety would go away." RN 1 documented that he placed Patient 307 on oxygen at 4:00 a.m.

According to the physician's orders, oxygen was to be used to maintain oxygen saturation levels to greater than 92%. RN 1 was asked why he found the need to place Patient 307 on oxygen at 4:00 a.m., as the recorded oxygen saturation at that time was 96%. According to RN 1, he did not recall placing the patient on oxygen, although he did acknowledge documenting the administration of oxygen in Patient 307's medical record at 4:00 a.m.

On 9/17/11 at 5:38 a.m., approximately 10 hours following Patient 307's fall, the phlebotomist (P1) came to the 7th floor for her routine blood draws. (P1) was interviewed on 9/29/11 at 10:30 a.m. and 11/18/11 at 4:00 a.m. According to P1, she drew Patient 307's blood the day before and he was "cranky and bitchy," but on the morning of 9/17/11 she was unable to arouse him. She stated the patient seemed "drugged," and "snoring in a deep sleep." She said, "I couldn't wake him up." P1 recalled a nurse outside the room. P1 stated the nurse must have heard her yelling to wake the patient up and P1 said, "I assumed the nurse told someone."

On the morning of 9/17/11 at 6:00 a.m., RN 1 found Patient 307 unresponsive, with a documented Glasgow Coma Scale (GCS) score of 3, on a scale of 3-15. (Glasgow Coma Scale is a neurological scale that aims to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessments). Three on the GCS indicates the patient does not open his eyes, is unable to make any verbal response or movement, and is in a deep unconsciousness.

RN 1 stated Patient 307 had no voluntary movement, even to a deep sternal rub. (A deep sternal rub is a forceful rub to the sternum (breast bone) to elicit a response from the patient.) RN 1 stated Patient 307's pupils were non-reactive (no reaction when a light is passed over the pupils). RN 1 stated he asked the Resource Nurse to "validate" his findings regarding the unconscious state of Patient 307. According to RN 1, the Resource Nurse had the same observations as RN 1. RN 1 stated he notified the on-call physician, Physician G, who was, "Sitting on the nurse's station." According to RN 1, he reported to Physician G that Patient 307 was " non-responsive," but Physician G stated he was off duty and told RN 1 to notify the oncoming physician, Physician L.

RN 1 stated he then called Patient 307's physician, Physician L, and waited for Physician L to arrive. When Physician L arrived, he initiated notification of the RRT (Rapid Response Team - a team of multidisciplinary staff most frequently consisting of ICU (Intensive Care Unit) trained personnel, who are available 24 hours per day, 7 days per week for evaluation of patients who develop signs or symptoms of [DIAGNOSES REDACTED].

Physician G was interviewed by phone on 12/27/11 at 3:20 p.m. According to Physician G, he was on shift from 10:00 p.m. to 6:00 a.m. Physician G stated Physician Y did not report off to him that Patient 307 had fallen. According to Physician G, the first time he heard about a fall or any problem with Patient A was after Physician L came on shift at 6:00 a.m. Physician G stated no one approached him at the nursing station regarding a patient in an unconscious state. Physician G stated he would not have told a nurse that he was "off duty" if there was an unconscious patient. He stated, "That's absurd."

The Respiratory Therapist (RT 1), working on the 7th floor, was the first RT to respond. RT 1 had no recall of the event. The second RT to respond (RT 2) was interviewed on 12/7/12 at 11:00 a.m. RT 2 stated she took over for RT 1 who was "bagging" (hand-held device used to provide positive pressure ventilation to a patient who is not breathing or who is breathing inadequately) the patient. RT 2 stated Patient 307 was non-responsive, comatose, and had a large bulge on his head that was covered with a bandage. Shortly thereafter, Patient 307 was intubated (breathing tube inserted for mechanical ventilation) by the ED physician. Then the Rapid Response Team arrived and hooked Patient 307 up to the monitors.

The Rapid Response Team Nurse (RRT 3), that responded on 9/17/11 at 6:35 a.m., was interviewed on 11/10/11 at 10:30 a.m. According to the RRT Nurse, whenever she responds to calls, she brings along a monitor and she hooks the patients up to the monitor. At the end of the call, she prints out a strip. The strip records ongoing vital signs and oxygen saturations. She then places the strip onto the RRT sheet, which she is responsible for filling out. RRT 3 pointed out the area on the RRT sheet where she attaches the strip. There was no strip attached to the RRT sheet. Neither the RRT, nor the Administrative Staff was able to explain why the printed strip was missing. RRT 3 stated she recalled that P1 (the phlebotomist) was the first to find Patient 307 unresponsive, when she entered the patient's room to draw the morning labs.

On 11/10/11 at 1:00 p.m., the Monitor Technician (MT) was interviewed regarding the recorded rhythm strips from 9/17/11 at 3:36 a.m. and 3:40 a.m. According to the MT, the facility documents rhythm strips in IMC every shift and with any changes in heart rhythm. The MT was questioned as to whether, after discovering a heart rate of 154, a rhythm strip would be obtained to indicate a change back to normal. The MT stated she would have done another strip indicating the change of rhythm back to normal. The MT could not explain what happened to the rhythm strip indicating a change after the elevated heart rate of 154. In fact, there were no documented strips in Patient 307's record from the 7th floor after the 3:40 a.m. strip, indicating a heart rate over 154.

The third CT Scan of Patient 307's brain was done on 9/17/11 at 7:45 a.m. The results were recorded as, "Marked increase in the right subdural hematoma ...measures 14 mm, compared to approximately 7 mm on previous examination (9/16/11 at 08:15 p.m.). There was an increase in the size of the midline shift and left ventricle. Interval development of left ventricular and fourth ventricular bleeding. New 2.7 cm left intraparenchymal bleeding centered over the left basal ganglia (essentially indicating the bleeding had expanded into the tissue and ventricles of the brain)."

A neurosurgical consultation was obtained on 9/17/11 at 9:13 a.m. According to the neurosurgeons dictated consultation, a phlebotomist found Patient 307 at 4:00 a.m., unresponsive. The neurosurgeons dictation indicated Patient 307 remained profoundly[DIAGNOSES REDACTED] (low platelet count, platelets assist with blood clotting) with increasing bleeding in the brain and noted, "Any prognosis for any meaningful recovery or survival is virtually nil ..."

A neurology consultation, obtained on 9/18/11 at 9:38 a.m., concurred with the neurosurgeon. The neurology consultation indicated Patient 307 had, "Hemorrhage in the pons of a fairly massive scale ...deeply comatose ...prognosis for any meaningful recovery is essentially zero ..."

Patient 307 continued to decline and the decision was made to change the level of care to Do Not Resuscitate (DNR) on 9/17/11 at 3:42 p.m. Patient 307 expired on [DATE] at 6:47 a.m. The coroner's report, dated 9/21/11, listed the cause of death as, "Complications of blunt force injury of head."

CDPH arrived at the facility on 9/22/11 at 9: 30 a.m., and met with the Chief Nursing Officer (CNO), who stated the Director of IMC did the investigation. Upon meeting with the Director of IMC, she stated the Manager did the investigation, who in turn stated the Interim Manager actually did the investigation, who in turn looked at the surveyor and stated, "I'm new at this, perhaps you (the Surveyor) can help me?" The Surveyor spoke briefly with the Chief of Quality to inquire who in the facility was actually responsible for the investigation, to which the Chief of Quality responded, "We do the RCA (root cause analysis), but we don't have anything to do with the investigation."

The Interim Manager stated she reviewed the record, "To ensure the RN did everything right." The Interim Manger admitted she was unaware of the elevation in Patient 307's heart rate over 154 at three in the morning, or the elevated CIWA scores, or the fact that RN 1 failed to call a rapid response team for assistance upon finding a patient with a GCS of 3.

The facility failed to sequester evidence. Although admitted ly, the facility had numerous problems with the alarms on the beds they were unable to ascertain which bed Patient 307 had been in. In addition, the cardiac monitoring history was gone from the machines memory. According to the onsite facility representative for the cardiac monitors, the facility maintains a 48 hour full disclosure recall except on discharged patients, and apparently this patient had been discharged from the floor. The facility was unable to produce any cardiac monitoring history. Administrative staff had no explanation as to the missing vital signs from RRT 3 or the rhythm strip establishing a change in HR following the 3:40 a.m. elevation of a heart rate over 154.

The facility had a policy entitled, Sentinel Event- Unusual Occurrence, which indicated the facility will, "Provide for security of any equipment or supplies that may be needed for future assessment of the situation...to collect information from individuals, chart forms, logs, etc. in order to create a complete chronology of events leading up to the incident,during the incident and following the incident as appropriate."

The investigation was limited to rectifying that the RN's actions were acceptable. The facility didn't provide any evidence that they had sequestered medical information or equipment which could have aided in creating a chronology of events that led to the incident. In fact the facility failed to show that any form of valuable investigation was done at all.


5. Patient 308, the fifth case, was admitted to an affiliated (sister) hospital (Hospital B) on 3/28/12. According to the Intensive Care Unit (ICU) Physician Discharge Summary dated 4/6/12, Patient 308 had, "A long standing history of psychiatric illness and multiple prior suicide attempts." The same H&P noted, "The patient was on a suicide watch, getting checked every 15 minutes. Between these frequent checks, the patient got a hold of a patient gown or a thin cloth that was used as a tie for the gown, tied it around her neck, tied it to a bar support in the bathroom, and lay down, creating essentially a hanging, choking sensation. She was found to be unresponsive and agonal. The code blue was called. She was ambu'd and required jaw thrust in order to ventilate. She was a difficult intubation, but ultimately was intubated and brought to the intensive care unit."
On 4/7/12, according to the psychiatric history and physical (H&P), Patient 308 was transferred back into Hospital B's Geropsychiatric unit on a 5250 (14 day hold) and "Needed a 24 hour sitter. " The plan was to admit to the sister facility's (Hospital A) Mental Health Unit to, "Monitor for safety."
On 4/18/12, according to the Nursing Narrative Notes, Patient (308) was, "Received as a transfer from the Geropsychiatric Unit (Hospital B) at 1430 (2:30 p.m. to Hospital A's MHU) via stretcher and two escorts ...Per Nursing Supervisor, patient placed on 15 (minute) safety checks."
On 4/19/12 at 10:34 p.m., a code blue was called, according to the code blue sheet. Patient 308 was taken to the trauma resuscitative room at 10: 41 p.m. and at 10:43 patient 308 was pronounced dead in the emergency room .
The Nursing Narrative Notes, timed and dated at 4/19/12 4:42 a.m., were reviewed. According to the notes at 10:15 Patient 308 was, "Still in the bathroom and stated she was ok (door to bathroom closed)." At 10:30, "I did not see the (patient) in her room, so I opened the bathroom door and found the (patient) in a sitting (crouching) position in front of the sink, a hospital gown was tied around the soap dispenser above the sink, she did not respond to questions. I called for help and another nurse helped lift the patient up to release the tension, she was lowered to the floor and a code blue was called. CPR was initiated by an RN and when the Code team came to the unit she was transferred to the ER."

The 15-minute Patient Monitoring Log for Safety sheets were reviewed on 6/8/12. The 15-minute checks were not started until 4:45 p.m. on 4/18/12. The 30 minute rounds, done on all patients in the Mental Health Unit, were not started until 4:30 p.m. on 4/18/12, two hours after arrival to the unit.

Further review of the 30-minute round checks, done on all patients in the unit, in comparison with the 15-minute Safety Monitoring checks, indicated the two forms of observation didn't match up. On 4/18/12 at 6:30 p.m., 6:45 p.m. and 7:00 p.m., Patient 308 was noted on the 15-minute Safety Monitoring checks to be in her room awake, however on the 30-minute rounds sheet, Patient 308 was noted to be in the lounge at 6:30 and 7:00 p.m.

On 4/19/12 at 5:30 and 5:45 p.m., the 15-minute Safety Checks indicated Patient 308 was in her room awake, however the 30-minute Rounds indicated Patient 308 was in the dining room at 5:30 and in her room at 6:00 p.m. Both the 15 minute and 30 minute rounds were done by the same CNA.

On 9/25/12 at 6:00 a.m., the facility Mental Health Unit was toured. The Round Sheets and the 15-minute safety check sheets were reviewed. The sheets were incomplete for the previous 30-minute check and the previous 15-minute check. The CNA stated, "I'm late on my rounds."

On 9/27/12 at 11:30 a.m., the Mental Health Unit was entered with Administrative Staff and again the rounds weren't up to the current time. Administrative Staff called the CNA to offer an explanation to the Surveyor. According to the CNA, she was, "Waiting for the patients to come to the dining room."

On 6/19/12 at 2:35 p.m. and 9/25/12 at 6:30 a.m., several staff members in the Mental Health Unit were interviewed related to the policy and practice of patient gowns and their availability to patients in the mental health unit. According to all the staff members, including a Charge Nurse that's worked on the unit for over 8 years, the policy and practice was to keep the gowns locked up.

The Manager of the Mental Health Unit was interviewed on 6/19/12 at 2:45 p.m., and stated she believed Patient 308 may have simply walked into another patient's room and picked up a gown off a bed. The Manager further stated, "There is no policy about locking up the gowns." When questioned why her staff seem to believe the policy and practice was to lock up the gowns, she stated "the gowns are locked up because we keep them with other supplies that need to be locked up." The Manger acknowledged that the facility policy for rounds included, "Direct observation." The Manger acknowledged the staff failed to directly observe Patient 308 on, "The last round" (prior to finding Patient 308 hanging on the soap dispenser in the bathroom). According to the Manager, she thought a correction might be to change the policy so direct observation wasn't necessary in order to, "Preserve patient privacy."

On 9/26/12 at 11:00 a.m. and 9/27/12 at 4:00 p.m., Administrative and Quality Staff were interviewed related to concerns of investigations not being thorough or missing. The Quality Staff had already informed CDPH an RCA was never done on the initial attempt of Patient 308 to hang herself at Hospital B because, "She was discharged ." However, admitted ly the patient was discharged from Hospital B to Hospital A and the same Quality Team was responsible for Hospital A and Hospital B. The Chief of Quality stated, "In retrospect, we probably should have done an RCA on that one."

The concern was raised during that meeting that without thorough investigations of near miss or unusual occurrences the facility was failing to provide a safe environment for the patients it cared for and was missing an opportunity to avoid reoccurrence of the same events.

6. On 7/31/12, the facility self reported the sixth event, which was witnessed by the media. According to the report to CDPH a patient (Patient 309) had been triaged and was waiting in the emergency room (ER) waiting room. The patient left the waiting room and was overheard saying he wanted to kill himself. According to the facility report, the patient was, "Prevented from falling and was not harmed."

On 8/1/12 at 9:00 a.m., CDPH entered the facility, to review the case above. The ER Management Staff was interviewed. According to the ER Manager, Patient 309 was there for "detox" from crystal methamphetamines. The Physician Assistant (PA) triaged the patient. There were no beds in the ER, so the patient was sent back to the waiting room. Patient 309 left the waiting room and went to the 6th floor and was heard threatening to jump. The ER Technician pulled the patient back before he jumped over the rail. ER Management Staff could not access the Electronic Medical Record (EMR). The Chief Nursing Officer (CNO) was notified of the facility's repeated difficulty accessing and printing the EMR.

The EMR was reviewed on 8/3/12. According to the ER SIGN IN SHEET, Patient 309 was there for, "Medical Clearance for sobering services (possible ingestion of "speed" in his trail mix." The patient was signed into registration at 7:12 p.m. with admitting diagnoses listed as, "Psychiatric."

According to the Registration Clerk, interviewed on 8/2/12 at 12:11 p.m., she received the diagnoses from the Triage Nurse. The primary triage assessment was done out front in the waiting area and timed at 7:22 p.m., according to the EMR. The focused assessment was started at 7:58 p.m.

The focused assessment was reviewed with the RN responsible 9 RN 1) on 8/17/12 at 1:00 p.m. The focused assessment incl
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the hospital's the Quality Assurance and Performance Improvement (QAPI) program did not identify and reduce medical errors This resulted in the potential for repeat of the same type of events and further patient harm.

Findings:

1. On 9/26/12 at 2:50 p.m., the Director of Quality and Patient Safety brought several large boxes filled with paper Quality Review Reports (QRRs). It was clear to the survey team that there was no practical way to review these for completion.

The Director used her laptop to bring up a log of reported QRR's. A brief scan of the log revealed the case of a patient (116) who attempted suicide on 6/27/12. The entry date for the QRR was 8/10/12, six weeks after the adverse event. At first the Director did not know of the case. She then remembered being called by one of the Quality Nurses about the event, but thought she was referencing a previous attempted suicide by another patient. The call occurred in August 2012, when the QRR was entered into the system, six weeks after the event. For this reason, another investigation was not begun on this new case. Also, no explanation could be given for the six week delay between the event and the logging in of the QRR.

The Quality Nurse involved was interviewed later (see 9/27/12 at 2:55 p.m.) and stated that she never had feedback on cases reported to the Director, so she never knew there was no RCA on this case or that there had been a misidentification of the case.

The Director also stated that the Quality Nurses, who reviewed all of the QRR's and either accepted them, or passed them on, consisted of 2 nurses at the downtown campus, one nurse at the Poway facility who reviewed the QRRs only from that hospital, one at the new campus, and one open position at the new campus. The Director stated that the investigations had to be prioritized due to workload. The Director said she was expected to be called or emailed for cases involving possible harm.

2. A second case was seen on the log of a patient (117) who reportedly had a hip replacement and then a reopening of the surgery due to a fracture seen on x-ray. Again, the Director did not know of the case. Further investigation showed that a Quality Nurse had initialed the QRR as not needing further investigation, but no documentation of her findings. Review of the patient record showed that the case was reopened because the prosthesis was not a good fit, not because of a fracture. The Director explained that the nurses review most of the QRRs and initial if no further investigation was needed. However, they may not document their own review, or may document it minimally. In this particular case, the Surveyor had to follow the paper trail in the medical record anew since there was no documentation as to why the Quality Nurse initialed it as complete.
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3. Patient 310, a third case, involved a facility-reported event. An anonymous member of the Operating Room (OR) team for this patient's procedure, reported that a patient had gallbladder surgery, but was found to have already had the gallbladder removed prior to the surgery.

Patient 310 was admitted to the facility on [DATE] for laparoscopic cholecystectomy (removal of the gallbladder with a small surgical scope through a small incision into the abdomen). Surgeon B performed the procedure. When he advanced the scope into the region of the gallbladder, he discovered that there was no gallbladder.

Surgeon B discussed this case with the Physician Surveyor in the administration conference room on 9/25/12 at 10:50 a.m. He first saw the patient in his office. The patient had been sent by the primary physician, because of gallstones on the ultrasound. The ultrasound, which he described as recent, maybe 6 months old, but could not be more specific, showed a small, contracted gallbladder with small stones and a question of a lesion on the kidney. The kidney finding made him think of renal [DIAGNOSES REDACTED] (cancer), but this was not found to be true on CT scan. He obtained a medical history at that visit in his office. The patient presented with symptoms consistent with inflammation of the gallbladder. The patient thought she might have had her gallbladder out "years" ago, but was not sure. The only visible scar was a nonspecific periumbilical scar.

The thing that most drove the surgeon's thinking was the ultrasound that showed a gallbladder with stones. The report did not have any lack of clarity like "maybe" or "could be." It said, "Contracted gallbladder with stones." He obtained a CT scan to help clarify. The kidney just had a complex cyst that required no intervention at this time. The report said the patient, "May have had a cholecystectomy, correlate clinically." Surgeon B said that CT was not a good study for the biliary system (liver and gall bladder and their drainage ducts) and that the ultrasound was much more reliable.

At this point he stated he didn't know why everyone was making, "Such a big deal out of this." He stated that perhaps he should have made the surgical consent for a lap exploration because of the uncertainty. After the procedure, he confirmed that the name and all the information from the radiology company matched the patient. He surmised that the ultrasound may have visualized a large cystic duct (the duct of the gall bladder) stump with stones, not uncommon in a patient with a sluggish biliary system after removal of the gall bladder. This would have been small and covered over with other tissue during the laparoscopy. After surgery, the patient was disappointed that there was no answer as to the cause of her symptoms, but did not appear angry with him. The family also seemed understanding. He mentioned that the daughter works in a doctor's office (possibly the referring physician), and served as the interpreter and he felt that communication was good throughout the pre, intra and post-operative processes.

When asked whether anyone from Administration or the Quality Department had contacted him, he said he had received a call and told the whole story to someone, but he could not recall the name or title of that person.

The Director of Quality was present during the interview with Surgeon B. When Surgeon B left the room, she stated she was the one who had spoken to the doctor on the phone. She stated she had no record of the conversation, no log of the call, and performed no further investigation. The event was not sent for peer review or to any of the quality-related committees.

4. The fourth case was Patient 307, a [AGE] year old male, who was seen in the facility's Emergency Department (ED) on 9/14/11 at approximately 2:03 p.m. According to the ED notes, Patient 307 presented with signs and symptoms that were consistent with an alcohol withdrawal syndrome. The notes indicated Patient 307 had a generalized tonic clonic seizure (generalized seizure affecting the entire brain), lasting approximately 2 minutes, while waiting for evaluation in the ED, and another seizure while still in the ED. Patient 307's Significant Other reported multiple falls at home, and the ED physician noted Patient 307 had multiple resolving ecchymosis (bruising) on his arms and legs. The notes indicated Patient 307's last alcoholic drink was the day prior, on 9/13/11. The ED physician ordered a CT scan of the brain (imaging studies of the brain) prior to Patient 307 being admitted to the 7th floor. The reason for the CT, according to the ED notes, was for an altered level of consciousness. The CT done in the ED was normal, according to the radiologists report.

Patient 307 was admitted to the IMC on the 7 7th floor, on 9/14/11 at approximately 8:00 p.m., according to the nursing documentation. Observation of the 7th floor determined the room Patient 307 was placed in, was not visible from the nursing station. The admitting physician's history and physical (H&P) was reviewed on 12/7/11. According to the H&P, Patient 307 had new seizures related to alcohol withdrawal and a diagnosis of [DIAGNOSES REDACTED]

The Physician ordered seizure and fall precautions, as well as Clinical Institute Withdrawal Assessment (CIWA) protocol.

The CIWA protocol was reviewed with Administrative Staff on 12/7/11. According to Administrative Staff, the facility utilized a CIWA protocol order set entitled, Alcohol Withdrawal Order Set. According to the order set, nursing staff are to:

1. Assess and record the CIWA scores every four hours for a minimum of 13 total assessments (48 hours of initial assessment). Built into the order set are parameters for notification of the physician. According to the order set, the physician should be notified for:
2. An elevated blood pressure (systolic over 160).
3. A heart rate greater than 100. In Patient 307's case, the physician changed the perimeter to be notified for a heart rate greater than 120.
4. Another of the perimeters for physician notification was a CIWA score greater than 15. According to Administrative Staff, the reason for notification of the physician of CIWA scores greater than 15 was because once a patient's score was greater than 15 it meant, "The patient is too much to handle in IMC and needs to be transferred to ICU."

Registered Nurse (RN) 2, the first nurse to care for Patient 307 on the day of admission and again the following day (9/14/11 and 9/15/11 from 7 a.m. to 7 p.m.), was interviewed on 12/7/11 at 10:00 a.m. According to RN 2, Patient 307 was "really confused" and "out of it." He recalled the patient was "impulsive" and "wouldn't listen." RN 2 stated the patient had been found out of bed in the bathroom holding his tab alarm. (Tab alarm is a device connected to the patient's clothing and to the bed, so that when the patient gets out of bed, the alarm becomes detached and emits a loud noise.) RN 2 stated that Patient 307 took the entire tab alarm unit with him, so that the alarm would not disconnect from his person and therefore, no alarm would sound. RN 2 stated he found Patient 307 with his legs up over the rails of the bed and found him several times trying to get out of the bed. RN 2 did not recall if the bed alarms were on (bed alarms sound when the patient gets out of bed). According to RN 2 he told the charge nurse (CN X) that Patient 307 should be on a one-to-one (1:1) status (one nurse or a sitter to one patient for constant observation). RN 2 stated the Charge Nurse said she would see what she could do. RN 2 stated he warned the oncoming nurse (RN 3) to keep an eye on Patient 307.

According to the clinical record Patient 307 was not placed on a 1:1 status.

RN 3, the nurse caring for Patient 307 on 9/15/11 and 9/16/11 from 7:00 a.m. to 7:00 p.m., was interviewed on 11/10/11 at 11:00 a.m. and again on 12/7/11 at 5:30 p.m. RN 3 stated that Patient 307 was "impulsive" and "would get out of bed" and "would not follow directions." The staff continually reminded Patient 307 to ask for help before getting out of bed, but he wouldn't. RN 3 recalled the bed alarms were not in use, but didn't know why. According to RN 3, she had just been in the room prior to Patient 307 falling and had told him to stay in bed. A review of RN 3's documentation indicated one CIWA assessment was recorded on the morning of 9/16/11 at 8:00 a.m. The 12:00 p.m. and 4:00 p.m. CIWA assessments, prior to the fall, were missing.

RN 1, the nurse caring for Patient 307 on 9/16/11 from 7:00 p.m. to 7:00 a.m., was interviewed on 9/28/11 at 12:00 p.m. and 12/7/11 at 11:45 a.m. RN 1 recalled Patient 307 had a tab alarm on, but no bed alarms. According to RN 1, just prior to the fall, Patient 307 showed RN 1 that Patient 307 knew how to take the bed alarm off without the alarm sounding. RN 1 stated that Patient 307 said, "It's like the old car alarms," and proceeded to take the tab alarm off without it sounding and then put it back on. RN 1 stated he felt that Patient 307 should have been on a 1:1. RN 1 stated that after Patient 307 demonstrated he could remove the alarm without it sounding, RN 1 and RN 3 continued on to the next room for bedside report. After they left the room, they heard a "thud" coming from Patient 307's room. When they entered the room, Patient 307 was laying on the floor with his alarm in hand, still not sounding. Patient 307 was bleeding from his head and his nose.

Nursing staff notified the on-call physician and received orders for a CT scan of the head. According to the radiologists report, the CT Scan following the fall, showed a 2 cm acute right subdural hematoma (a collection of blood on the surface of the brain) and a 3 millimeter (mm) midline shift. (A shift of the brain, past its center line, is considered ominous, because it is commonly associated with a distortion of the [DIAGNOSES REDACTED] that can cause serious dysfunction, evidenced by abnormal posturing and failure of the pupils to constrict in response to light.)

The on-call physician (Physician Y) was notified of the results of the CT scan and ordered neurological signs every hour for 6 hours and then every 4 hours.

Following the fall, on the evening of 9/16/11, RN 1 documented CIWA assessments of 16 at 11:00 p.m. and 17 at 1:00 a.m. When questioned as to the significance of the elevated scores, RN 1 stated he knew he should have notified the physician, but he did not.

At 3:36 a.m., the Monitor Technician took a rhythm strip of Patient A's heart rate, as she noted an increased heart rate of 138. Again at 3:40 a.m., another strip was recorded due to a heart rate of greater than 154. Both strips were initialed by RN 1. RN 1 acknowledged his initials on the rhythm strips.

RN 1 was questioned again as to why he didn't further assess Patient 307 or notify the physician, as the order was to notify the physician with a heart rate greater than 120. RN 1 acknowledged that with the elevated heart rate, further assessment was warranted, at least a full set of vital signs. He could not answer why he did not further assess Patient 307. RN 1 acknowledged he did not notify the physician. RN 1 stated he thought Patient 307 was, "Just anxious."

RN 1 was questioned as to why he medicated Patient 307 with Ativan for anxiety at 11:27 p.m. and 1:26 a.m., but didn't medicate Patient 307 for what RN 1 perceived as anxiety at 3:40 a.m. RN 1 stated, "I thought the anxiety would go away." RN 1 documented that he placed Patient 307 on oxygen at 4:00 a.m.

According to the physician's orders, oxygen was to be used to maintain oxygen saturation levels to greater than 92%. RN 1 was asked why he found the need to place Patient 307 on oxygen at 4:00 a.m., as the recorded oxygen saturation at that time was 96%. According to RN 1, he did not recall placing the patient on oxygen, although he did acknowledge documenting the administration of oxygen in Patient 307's medical record at 4:00 a.m.

On 9/17/11 at 5:38 a.m., approximately 10 hours following Patient 307's fall, the phlebotomist (P1) came to the 7th floor for her routine blood draws. (P1) was interviewed on 9/29/11 at 10:30 a.m. and 11/18/11 at 4:00 a.m. According to P1, she drew Patient 307's blood the day before and he was "cranky and bitchy," but on the morning of 9/17/11 she was unable to arouse him. She stated the patient seemed "drugged," and "snoring in a deep sleep." She said, "I couldn't wake him up." P1 recalled a nurse outside the room. P1 stated the nurse must have heard her yelling to wake the patient up and P1 said, "I assumed the nurse told someone."

On the morning of 9/17/11 at 6:00 a.m., RN 1 found Patient 307 unresponsive, with a documented Glasgow Coma Scale (GCS) score of 3, on a scale of 3-15. (Glasgow Coma Scale is a neurological scale that aims to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessments). Three on the GCS indicates the patient does not open his eyes, is unable to make any verbal response or movement, and is in a deep unconsciousness.

RN 1 stated Patient 307 had no voluntary movement, even to a deep sternal rub. (A deep sternal rub is a forceful rub to the sternum (breast bone) to elicit a response from the patient.) RN 1 stated Patient 307's pupils were non-reactive (no reaction when a light is passed over the pupils). RN 1 stated he asked the Resource Nurse to "validate" his findings regarding the unconscious state of Patient 307. According to RN 1, the Resource Nurse had the same observations as RN 1. RN 1 stated he notified the on-call physician, Physician G, who was, "Sitting on the nurse's station." According to RN 1, he reported to Physician G that Patient 307 was " non-responsive," but Physician G stated he was off duty and told RN 1 to notify the oncoming physician, Physician L.

RN 1 stated he then called Patient 307's physician, Physician L, and waited for Physician L to arrive. When Physician L arrived, he initiated notification of the RRT (Rapid Response Team - a team of multidisciplinary staff most frequently consisting of ICU (Intensive Care Unit) trained personnel, who are available 24 hours per day, 7 days per week for evaluation of patients who develop signs or symptoms of [DIAGNOSES REDACTED].

Physician G was interviewed by phone on 12/27/11 at 3:20 p.m. According to Physician G, he was on shift from 10:00 p.m. to 6:00 a.m. Physician G stated Physician Y did not report off to him that Patient 307 had fallen. According to Physician G, the first time he heard about a fall or any problem with Patient A was after Physician L came on shift at 6:00 a.m. Physician G stated no one approached him at the nursing station regarding a patient in an unconscious state. Physician G stated he would not have told a nurse that he was "off duty" if there was an unconscious patient. He stated, "That's absurd."

The Respiratory Therapist (RT 1), working on the 7th floor, was the first RT to respond. RT 1 had no recall of the event. The second RT to respond (RT 2) was interviewed on 12/7/12 at 11:00 a.m. RT 2 stated she took over for RT 1 who was "bagging" (hand-held device used to provide positive pressure ventilation to a patient who is not breathing or who is breathing inadequately) the patient. RT 2 stated Patient 307 was non-responsive, comatose, and had a large bulge on his head that was covered with a bandage. Shortly thereafter, Patient 307 was intubated (breathing tube inserted for mechanical ventilation) by the ED physician. Then the Rapid Response Team arrived and hooked Patient 307 up to the monitors.

The Rapid Response Team Nurse (RRT 3), that responded on 9/17/11 at 6:35 a.m., was interviewed on 11/10/11 at 10:30 a.m. According to the RRT Nurse, whenever she responds to calls, she brings along a monitor and she hooks the patients up to the monitor. At the end of the call, she prints out a strip. The strip records ongoing vital signs and oxygen saturations. She then places the strip onto the RRT sheet, which she is responsible for filling out. RRT 3 pointed out the area on the RRT sheet where she attaches the strip. There was no strip attached to the RRT sheet. Neither the RRT, nor the Administrative Staff was able to explain why the printed strip was missing. RRT 3 stated she recalled that P1 (the phlebotomist) was the first to find Patient 307 unresponsive, when she entered the patient's room to draw the morning labs.

On 11/10/11 at 1:00 p.m., the Monitor Technician (MT) was interviewed regarding the recorded rhythm strips from 9/17/11 at 3:36 a.m. and 3:40 a.m. According to the MT, the facility documents rhythm strips in IMC every shift and with any changes in heart rhythm. The MT was questioned as to whether, after discovering a heart rate of 154, a rhythm strip would be obtained to indicate a change back to normal. The MT stated she would have done another strip indicating the change of rhythm back to normal. The MT could not explain what happened to the rhythm strip indicating a change after the elevated heart rate of 154. In fact, there were no documented strips in Patient 307's record from the 7th floor after the 3:40 a.m. strip, indicating a heart rate over 154.

The third CT Scan of Patient 307's brain was done on 9/17/11 at 7:45 a.m. The results were recorded as, "Marked increase in the right subdural hematoma ...measures 14 mm, compared to approximately 7 mm on previous examination (9/16/11 at 08:15 p.m.). There was an increase in the size of the midline shift and left ventricle. Interval development of left ventricular and fourth ventricular bleeding. New 2.7 cm left intraparenchymal bleeding centered over the left basal ganglia (essentially indicating the bleeding had expanded into the tissue and ventricles of the brain)."

A neurosurgical consultation was obtained on 9/17/11 at 9:13 a.m. According to the neurosurgeons dictated consultation, a phlebotomist found Patient 307 at 4:00 a.m., unresponsive. The neurosurgeons dictation indicated Patient 307 remained profoundly[DIAGNOSES REDACTED] (low platelet count, platelets assist with blood clotting) with increasing bleeding in the brain and noted, "Any prognosis for any meaningful recovery or survival is virtually nil ..."

A neurology consultation, obtained on 9/18/11 at 9:38 a.m., concurred with the neurosurgeon. The neurology consultation indicated Patient 307 had, "Hemorrhage in the pons of a fairly massive scale ...deeply comatose ...prognosis for any meaningful recovery is essentially zero ..."

Patient 307 continued to decline and the decision was made to change the level of care to Do Not Resuscitate (DNR) on 9/17/11 at 3:42 p.m. Patient 307 expired on [DATE] at 6:47 a.m. The coroner's report, dated 9/21/11, listed the cause of death as, "Complications of blunt force injury of head."

CDPH arrived at the facility on 9/22/11 at 9: 30 a.m., and met with the Chief Nursing Officer (CNO), who stated the Director of IMC did the investigation. Upon meeting with the Director of IMC, she stated the Manager did the investigation, who in turn stated the Interim Manager actually did the investigation, who in turn looked at the surveyor and stated, "I'm new at this, perhaps you (the Surveyor) can help me?" The Surveyor spoke briefly with the Chief of Quality to inquire who in the facility was actually responsible for the investigation, to which the Chief of Quality responded, "We do the RCA (root cause analysis), but we don't have anything to do with the investigation."

The Interim Manager stated she reviewed the record, "To ensure the RN did everything right." The Interim Manger admitted she was unaware of the elevation in Patient 307's heart rate over 154 at three in the morning, or the elevated CIWA scores, or the fact that RN 1 failed to call a rapid response team for assistance upon finding a patient with a GCS of 3.

The facility failed to sequester evidence. Although admitted ly, the facility had numerous problems with the alarms on the beds they were unable to ascertain which bed Patient 307 had been in. In addition, the cardiac monitoring history was gone from the machines memory. According to the onsite facility representative for the cardiac monitors, the facility maintains a 48 hour full disclosure recall except on discharged patients, and apparently this patient had been discharged from the floor. The facility was unable to produce any cardiac monitoring history. Administrative staff had no explanation as to the missing vital signs from RRT 3 or the rhythm strip establishing a change in HR following the 3:40 a.m. elevation of a heart rate over 154.

The facility had a policy entitled, Sentinel Event- Unusual Occurrence, which indicated the facility will, "Provide for security of any equipment or supplies that may be needed for future assessment of the situation...to collect information from individuals, chart forms, logs, etc. in order to create a complete chronology of events leading up to the incident,during the incident and following the incident as appropriate."

The investigation was limited to rectifying that the RN's actions were acceptable. The facility didn't provide any evidence that they had sequestered medical information or equipment which could have aided in creating a chronology of events that led to the incident. In fact the facility failed to show that any form of valuable investigation was done at all.


5. Patient 308, the fifth case, was admitted to an affiliated (sister) hospital (Hospital B) on 3/28/12. According to the Intensive Care Unit (ICU) Physician Discharge Summary dated 4/6/12, Patient 308 had, "A long standing history of psychiatric illness and multiple prior suicide attempts." The same H&P noted, "The patient was on a suicide watch, getting checked every 15 minutes. Between these frequent checks, the patient got a hold of a patient gown or a thin cloth that was used as a tie for the gown, tied it around her neck, tied it to a bar support in the bathroom, and lay down, creating essentially a hanging, choking sensation. She was found to be unresponsive and agonal. The code blue was called. She was ambu'd and required jaw thrust in order to ventilate. She was a difficult intubation, but ultimately was intubated and brought to the intensive care unit."
On 4/7/12, according to the psychiatric history and physical (H&P), Patient 308 was transferred back into Hospital B's Geropsychiatric unit on a 5250 (14 day hold) and "Needed a 24 hour sitter. " The plan was to admit to the sister facility's (Hospital A) Mental Health Unit to, "Monitor for safety."
On 4/18/12, according to the Nursing Narrative Notes, Patient (308) was, "Received as a transfer from the Geropsychiatric Unit (Hospital B) at 1430 (2:30 p.m. to Hospital A's MHU) via stretcher and two escorts ...Per Nursing Supervisor, patient placed on 15 (minute) safety checks."
On 4/19/12 at 10:34 p.m., a code blue was called, according to the code blue sheet. Patient 308 was taken to the trauma resuscitative room at 10: 41 p.m. and at 10:43 patient 308 was pronounced dead in the emergency room .
The Nursing Narrative Notes, timed and dated at 4/19/12 4:42 a.m., were reviewed. According to the notes at 10:15 Patient 308 was, "Still in the bathroom and stated she was ok (door to bathroom closed)." At 10:30, "I did not see the (patient) in her room, so I opened the bathroom door and found the (patient) in a sitting (crouching) position in front of the sink, a hospital gown was tied around the soap dispenser above the sink, she did not respond to questions. I called for help and another nurse helped lift the patient up to release the tension, she was lowered to the floor and a code blue was called. CPR was initiated by an RN and when the Code team came to the unit she was transferred to the ER."

The 15-minute Patient Monitoring Log for Safety sheets were reviewed on 6/8/12. The 15-minute checks were not started until 4:45 p.m. on 4/18/12. The 30 minute rounds, done on all patients in the Mental Health Unit, were not started until 4:30 p.m. on 4/18/12, two hours after arrival to the unit.

Further review of the 30-minute round checks, done on all patients in the unit, in comparison with the 15-minute Safety Monitoring checks, indicated the two forms of observation didn't match up. On 4/18/12 at 6:30 p.m., 6:45 p.m. and 7:00 p.m., Patient 308 was noted on the 15-minute Safety Monitoring checks to be in her room awake, however on the 30-minute rounds sheet, Patient 308 was noted to be in the lounge at 6:30 and 7:00 p.m.

On 4/19/12 at 5:30 and 5:45 p.m., the 15-minute Safety Checks indicated Patient 308 was in her room awake, however the 30-minute Rounds indicated Patient 308 was in the dining room at 5:30 and in her room at 6:00 p.m. Both the 15 minute and 30 minute rounds were done by the same CNA.

On 9/25/12 at 6:00 a.m., the facility Mental Health Unit was toured. The Round Sheets and the 15-minute safety check sheets were reviewed. The sheets were incomplete for the previous 30-minute check and the previous 15-minute check. The CNA stated, "I'm late on my rounds."

On 9/27/12 at 11:30 a.m., the Mental Health Unit was entered with Administrative Staff and again the rounds weren't up to the current time. Administrative Staff called the CNA to offer an explanation to the Surveyor. According to the CNA, she was, "Waiting for the patients to come to the dining room."

On 6/19/12 at 2:35 p.m. and 9/25/12 at 6:30 a.m., several staff members in the Mental Health Unit were interviewed related to the policy and practice of patient gowns and their availability to patients in the mental health unit. According to all the staff members, including a Charge Nurse that's worked on the unit for over 8 years, the policy and practice was to keep the gowns locked up.

The Manager of the Mental Health Unit was interviewed on 6/19/12 at 2:45 p.m., and stated she believed Patient 308 may have simply walked into another patient's room and picked up a gown off a bed. The Manager further stated, "There is no policy about locking up the gowns." When questioned why her staff seem to believe the policy and practice was to lock up the gowns, she stated "the gowns are locked up because we keep them with other supplies that need to be locked up." The Manger acknowledged that the facility policy for rounds included, "Direct observation." The Manger acknowledged the staff failed to directly observe Patient 308 on, "The last round" (prior to finding Patient 308 hanging on the soap dispenser in the bathroom). According to the Manager, she thought a correction might be to change the policy so direct observation wasn't necessary in order to, "Preserve patient privacy."

On 9/26/12 at 11:00 a.m. and 9/27/12 at 4:00 p.m., Administrative and Quality Staff were interviewed related to concerns of investigations not being thorough or missing. The Quality Staff had already informed CDPH an RCA was never done on the initial attempt of Patient 308 to hang herself at Hospital B because, "She was discharged ." However, admitted ly the patient was discharged from Hospital B to Hospital A and the same Quality Team was responsible for Hospital A and Hospital B. The Chief of Quality stated, "In retrospect, we probably should have done an RCA on that one."

The concern was raised during that meeting that without thorough investigations of near miss or unusual occurrences the facility was failing to provide a safe environment for the patients it cared for and was missing an opportunity to avoid reoccurrence of the same events.

6. On 7/31/12, the facility self reported the sixth event, which was witnessed by the media. According to the report to CDPH a patient (Patient 309) had been triaged and was waiting in the emergency room (ER) waiting room. The patient left the waiting room and was overheard saying he wanted to kill himself. According to the facility report, the patient was, "Prevented from falling and was not harmed."

On 8/1/12 at 9:00 a.m., CDPH entered the facility, to review the case above. The ER Management Staff was interviewed. According to the ER Manager, Patient 309 was there for "detox" from crystal methamphetamines. The Physician Assistant (PA) triaged the patient. There were no beds in the ER, so the patient was sent back to the waiting room. Patient 309 left the waiting room and went to the 6th floor and was heard threatening to jump. The ER Technician pulled the patient back before he jumped over the rail. ER Management Staff could not access the Electronic Medical Record (EMR). The Chief Nursing Officer (CNO) was notified of the facility's repeated difficulty accessing and printing the EMR.

The EMR was reviewed on 8/3/12. According to the ER SIGN IN SHEET, Patient 309 was there for, "Medical Clearance for sobering services (possible ingestion of "speed" in his trail mix." The patient was signed into registration at 7:12 p.m. with admitting diagnoses listed as, "Psychiatric."

According to the Registration Clerk, interviewed on 8/2/12 at 12:11 p.m., she received the diagnoses from the Triage Nurse. The primary triage assessment was done out front in the waiting area and timed at 7:22 p.m., according to the EMR. The focused assessment was started at 7:58 p.m.

The focused assessment was reviewed with the RN responsible 9 RN 1) on 8/17/12 at 1:00 p.m. The focused assessment included a psychiatric assessment entitled, ED Suicide Risk Screening, which in
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and document review, the Quality Assurance and Performance Improvement (QAPI) program did not track all medical errors and adverse patient events, particularly the eight identified during the survey leading to an inability to analyze their causes. Performance improvement activities did not track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. This resulted in a failure of the hospital to make improvements to reduce these type of error and to provide educational feedback back to the hospital staff.


Findings:

During the course of multiple complaint investigations, the facility failed to conduct thorough investigations in response to the following adverse patient incidents:

1. Patient 307, a [AGE] year old male, who was seen in the facility's Emergency Department (ED) on 9/14/11 at approximately 2:03 p.m. According to the ED notes, Patient 307 presented with signs and symptoms that were consistent with an alcohol withdrawal syndrome. The notes indicated Patient 307 had a generalized tonic clonic seizure (generalized seizure affecting the entire brain), lasting approximately 2 minutes, while waiting for evaluation in the ED, and another seizure while still in the ED. Patient 307's Significant Other reported multiple falls at home, and the ED physician noted Patient 307 had multiple resolving ecchymosis (bruising) on his arms and legs. The notes indicated Patient 307's last alcoholic drink was the day prior, on 9/13/11. The ED physician ordered a CT scan of the brain (imaging studies of the brain) prior to Patient 307 being admitted to the 7th floor. The reason for the CT, according to the ED notes, was for an altered level of consciousness. The CT done in the ED was normal, according to the radiologists report.

Patient 307 was admitted to the IMC on the 7 7th floor, on 9/14/11 at approximately 8:00 p.m., according to the nursing documentation. Observation of the 7th floor determined the room Patient 307 was placed in, was not visible from the nursing station. The admitting physician's history and physical (H&P) was reviewed on 12/7/11. According to the H&P, Patient 307 had new seizures related to alcohol withdrawal and a diagnosis of [DIAGNOSES REDACTED]

The Physician ordered seizure and fall precautions, as well as Clinical Institute Withdrawal Assessment (CIWA) protocol.

The CIWA protocol was reviewed with Administrative Staff on 12/7/11. According to Administrative Staff, the facility utilized a CIWA protocol order set entitled, Alcohol Withdrawal Order Set. According to the order set, nursing staff are to:

1. Assess and record the CIWA scores every four hours for a minimum of 13 total assessments (48 hours of initial assessment). Built into the order set are parameters for notification of the physician. According to the order set, the physician should be notified for:
2. An elevated blood pressure (systolic over 160).
3. A heart rate greater than 100. In Patient 307's case, the physician changed the perimeter to be notified for a heart rate greater than 120.
4. Another of the perimeters for physician notification was a CIWA score greater than 15. According to Administrative Staff, the reason for notification of the physician of CIWA scores greater than 15 was because once a patient's score was greater than 15 it meant, "The patient is too much to handle in IMC and needs to be transferred to ICU."

Registered Nurse (RN) 2, the first nurse to care for Patient 307 on the day of admission and again the following day (9/14/11 and 9/15/11 from 7 a.m. to 7 p.m.), was interviewed on 12/7/11 at 10:00 a.m. According to RN 2, Patient 307 was "really confused" and "out of it." He recalled the patient was "impulsive" and "wouldn't listen." RN 2 stated the patient had been found out of bed in the bathroom holding his tab alarm. (Tab alarm is a device connected to the patient's clothing and to the bed, so that when the patient gets out of bed, the alarm becomes detached and emits a loud noise.) RN 2 stated that Patient 307 took the entire tab alarm unit with him, so that the alarm would not disconnect from his person and therefore, no alarm would sound. RN 2 stated he found Patient 307 with his legs up over the rails of the bed and found him several times trying to get out of the bed. RN 2 did not recall if the bed alarms were on (bed alarms sound when the patient gets out of bed). According to RN 2 he told the charge nurse (CN X) that Patient 307 should be on a one-to-one (1:1) status (one nurse or a sitter to one patient for constant observation). RN 2 stated the Charge Nurse said she would see what she could do. RN 2 stated he warned the oncoming nurse (RN 3) to keep an eye on Patient 307.

According to the clinical record Patient 307 was not placed on a 1:1 status.

RN 3, the nurse caring for Patient 307 on 9/15/11 and 9/16/11 from 7:00 a.m. to 7:00 p.m., was interviewed on 11/10/11 at 11:00 a.m. and again on 12/7/11 at 5:30 p.m. RN 3 stated that Patient 307 was "impulsive" and "would get out of bed" and "would not follow directions." The staff continually reminded Patient 307 to ask for help before getting out of bed, but he wouldn't. RN 3 recalled the bed alarms were not in use, but didn't know why. According to RN 3, she had just been in the room prior to Patient 307 falling and had told him to stay in bed. A review of RN 3's documentation indicated one CIWA assessment was recorded on the morning of 9/16/11 at 8:00 a.m. The 12:00 p.m. and 4:00 p.m. CIWA assessments, prior to the fall, were missing.

RN 1, the nurse caring for Patient 307 on 9/16/11 from 7:00 p.m. to 7:00 a.m., was interviewed on 9/28/11 at 12:00 p.m. and 12/7/11 at 11:45 a.m. RN 1 recalled Patient 307 had a tab alarm on, but no bed alarms. According to RN 1, just prior to the fall, Patient 307 showed RN 1 that Patient 307 knew how to take the bed alarm off without the alarm sounding. RN 1 stated that Patient 307 said, "It's like the old car alarms," and proceeded to take the tab alarm off without it sounding and then put it back on. RN 1 stated he felt that Patient 307 should have been on a 1:1. RN 1 stated that after Patient 307 demonstrated he could remove the alarm without it sounding, RN 1 and RN 3 continued on to the next room for bedside report. After they left the room, they heard a "thud" coming from Patient 307's room. When they entered the room, Patient 307 was laying on the floor with his alarm in hand, still not sounding. Patient 307 was bleeding from his head and his nose.

Nursing staff notified the on-call physician and received orders for a CT scan of the head. According to the radiologists report, the CT Scan following the fall, showed a 2 cm acute right subdural hematoma (a collection of blood on the surface of the brain) and a 3 millimeter (mm) midline shift. (A shift of the brain, past its center line, is considered ominous, because it is commonly associated with a distortion of the [DIAGNOSES REDACTED] that can cause serious dysfunction, evidenced by abnormal posturing and failure of the pupils to constrict in response to light.)

The on-call physician (Physician Y) was notified of the results of the CT scan and ordered neurological signs every hour for 6 hours and then every 4 hours.

Following the fall, on the evening of 9/16/11, RN 1 documented CIWA assessments of 16 at 11:00 p.m. and 17 at 1:00 a.m. When questioned as to the significance of the elevated scores, RN 1 stated he knew he should have notified the physician, but he did not.

At 3:36 a.m., the Monitor Technician took a rhythm strip of Patient A's heart rate, as she noted an increased heart rate of 138. Again at 3:40 a.m., another strip was recorded due to a heart rate of greater than 154. Both strips were initialed by RN 1. RN 1 acknowledged his initials on the rhythm strips.

RN 1 was questioned again as to why he didn't further assess Patient 307 or notify the physician, as the order was to notify the physician with a heart rate greater than 120. RN 1 acknowledged that with the elevated heart rate, further assessment was warranted, at least a full set of vital signs. He could not answer why he did not further assess Patient 307. RN 1 acknowledged he did not notify the physician. RN 1 stated he thought Patient 307 was, "Just anxious."

RN 1 was questioned as to why he medicated Patient 307 with Ativan for anxiety at 11:27 p.m. and 1:26 a.m., but didn't medicate Patient 307 for what RN 1 perceived as anxiety at 3:40 a.m. RN 1 stated, "I thought the anxiety would go away." RN 1 documented that he placed Patient 307 on oxygen at 4:00 a.m.

According to the physician's orders, oxygen was to be used to maintain oxygen saturation levels to greater than 92%. RN 1 was asked why he found the need to place Patient 307 on oxygen at 4:00 a.m., as the recorded oxygen saturation at that time was 96%. According to RN 1, he did not recall placing the patient on oxygen, although he did acknowledge documenting the administration of oxygen in Patient 307's medical record at 4:00 a.m.

On 9/17/11 at 5:38 a.m., approximately 10 hours following Patient 307's fall, the phlebotomist (P1) came to the 7th floor for her routine blood draws. (P1) was interviewed on 9/29/11 at 10:30 a.m. and 11/18/11 at 4:00 a.m. According to P1, she drew Patient 307's blood the day before and he was "cranky and bitchy," but on the morning of 9/17/11 she was unable to arouse him. She stated the patient seemed "drugged," and "snoring in a deep sleep." She said, "I couldn't wake him up." P1 recalled a nurse outside the room. P1 stated the nurse must have heard her yelling to wake the patient up and P1 said, "I assumed the nurse told someone."

On the morning of 9/17/11 at 6:00 a.m., RN 1 found Patient 307 unresponsive, with a documented Glasgow Coma Scale (GCS) score of 3, on a scale of 3-15. (Glasgow Coma Scale is a neurological scale that aims to give a reliable, objective way of recording the conscious state of a person for initial as well as subsequent assessments). Three on the GCS indicates the patient does not open his eyes, is unable to make any verbal response or movement, and is in a deep unconsciousness.

RN 1 stated Patient 307 had no voluntary movement, even to a deep sternal rub. (A deep sternal rub is a forceful rub to the sternum (breast bone) to elicit a response from the patient.) RN 1 stated Patient 307's pupils were non-reactive (no reaction when a light is passed over the pupils). RN 1 stated he asked the Resource Nurse to "validate" his findings regarding the unconscious state of Patient 307. According to RN 1, the Resource Nurse had the same observations as RN 1. RN 1 stated he notified the on-call physician, Physician G, who was, "Sitting on the nurse's station." According to RN 1, he reported to Physician G that Patient 307 was " non-responsive," but Physician G stated he was off duty and told RN 1 to notify the oncoming physician, Physician L.

RN 1 stated he then called Patient 307's physician, Physician L, and waited for Physician L to arrive. When Physician L arrived, he initiated notification of the RRT (Rapid Response Team - a team of multidisciplinary staff most frequently consisting of ICU (Intensive Care Unit) trained personnel, who are available 24 hours per day, 7 days per week for evaluation of patients who develop signs or symptoms of [DIAGNOSES REDACTED].

Physician G was interviewed by phone on 12/27/11 at 3:20 p.m. According to Physician G, he was on shift from 10:00 p.m. to 6:00 a.m. Physician G stated Physician Y did not report off to him that Patient 307 had fallen. According to Physician G, the first time he heard about a fall or any problem with Patient A was after Physician L came on shift at 6:00 a.m. Physician G stated no one approached him at the nursing station regarding a patient in an unconscious state. Physician G stated he would not have told a nurse that he was "off duty" if there was an unconscious patient. He stated, "That's absurd."

The Respiratory Therapist (RT 1), working on the 7th floor, was the first RT to respond. RT 1 had no recall of the event. The second RT to respond (RT 2) was interviewed on 12/7/12 at 11:00 a.m. RT 2 stated she took over for RT 1 who was "bagging" (hand-held device used to provide positive pressure ventilation to a patient who is not breathing or who is breathing inadequately) the patient. RT 2 stated Patient 307 was non-responsive, comatose, and had a large bulge on his head that was covered with a bandage. Shortly thereafter, Patient 307 was intubated (breathing tube inserted for mechanical ventilation) by the ED physician. Then the Rapid Response Team arrived and hooked Patient 307 up to the monitors.

The Rapid Response Team Nurse (RRT 3), that responded on 9/17/11 at 6:35 a.m., was interviewed on 11/10/11 at 10:30 a.m. According to the RRT Nurse, whenever she responds to calls, she brings along a monitor and she hooks the patients up to the monitor. At the end of the call, she prints out a strip. The strip records ongoing vital signs and oxygen saturations. She then places the strip onto the RRT sheet, which she is responsible for filling out. RRT 3 pointed out the area on the RRT sheet where she attaches the strip. There was no strip attached to the RRT sheet. Neither the RRT, nor the Administrative Staff was able to explain why the printed strip was missing. RRT 3 stated she recalled that P1 (the phlebotomist) was the first to find Patient 307 unresponsive, when she entered the patient's room to draw the morning labs.

On 11/10/11 at 1:00 p.m., the Monitor Technician (MT) was interviewed regarding the recorded rhythm strips from 9/17/11 at 3:36 a.m. and 3:40 a.m. According to the MT, the facility documents rhythm strips in IMC every shift and with any changes in heart rhythm. The MT was questioned as to whether, after discovering a heart rate of 154, a rhythm strip would be obtained to indicate a change back to normal. The MT stated she would have done another strip indicating the change of rhythm back to normal. The MT could not explain what happened to the rhythm strip indicating a change after the elevated heart rate of 154. In fact, there were no documented strips in Patient 307's record from the 7th floor after the 3:40 a.m. strip, indicating a heart rate over 154.

The third CT Scan of Patient 307's brain was done on 9/17/11 at 7:45 a.m. The results were recorded as, "Marked increase in the right subdural hematoma ...measures 14 mm, compared to approximately 7 mm on previous examination (9/16/11 at 08:15 p.m.). There was an increase in the size of the midline shift and left ventricle. Interval development of left ventricular and fourth ventricular bleeding. New 2.7 cm left intraparenchymal bleeding centered over the left basal ganglia (essentially indicating the bleeding had expanded into the tissue and ventricles of the brain)."

A neurosurgical consultation was obtained on 9/17/11 at 9:13 a.m. According to the neurosurgeons dictated consultation, a phlebotomist found Patient 307 at 4:00 a.m., unresponsive. The neurosurgeons dictation indicated Patient 307 remained profoundly[DIAGNOSES REDACTED] (low platelet count, platelets assist with blood clotting) with increasing bleeding in the brain and noted, "Any prognosis for any meaningful recovery or survival is virtually nil ..."

A neurology consultation, obtained on 9/18/11 at 9:38 a.m., concurred with the neurosurgeon. The neurology consultation indicated Patient 307 had, "Hemorrhage in the pons of a fairly massive scale ...deeply comatose ...prognosis for any meaningful recovery is essentially zero ..."

Patient 307 continued to decline and the decision was made to change the level of care to Do Not Resuscitate (DNR) on 9/17/11 at 3:42 p.m. Patient 307 expired on [DATE] at 6:47 a.m. The coroner's report, dated 9/21/11, listed the cause of death as, "Complications of blunt force injury of head."

CDPH arrived at the facility on 9/22/11 at 9: 30 a.m., and met with the Chief Nursing Officer (CNO), who stated the Director of IMC did the investigation. Upon meeting with the Director of IMC, she stated the Manager did the investigation, who in turn stated the Interim Manager actually did the investigation, who in turn looked at the surveyor and stated, "I'm new at this, perhaps you (the Surveyor) can help me?" The Surveyor spoke briefly with the Chief of Quality to inquire who in the facility was actually responsible for the investigation, to which the Chief of Quality responded, "We do the RCA (root cause analysis), but we don't have anything to do with the investigation."

The Interim Manager stated she reviewed the record, "To ensure the RN did everything right." The Interim Manger admitted she was unaware of the elevation in Patient 307's heart rate over 154 at three in the morning, or the elevated CIWA scores, or the fact that RN 1 failed to call a rapid response team for assistance upon finding a patient with a GCS of 3.

The facility failed to sequester evidence. Although admitted ly, the facility had numerous problems with the alarms on the beds they were unable to ascertain which bed Patient 307 had been in. In addition, the cardiac monitoring history was gone from the machines memory. According to the onsite facility representative for the cardiac monitors, the facility maintains a 48 hour full disclosure recall except on discharged patients, and apparently this patient had been discharged from the floor. The facility was unable to produce any cardiac monitoring history. Administrative staff had no explanation as to the missing vital signs from RRT 3 or the rhythm strip establishing a change in HR following the 3:40 a.m. elevation of a heart rate over 154.

The facility had a policy entitled, Sentinel Event- Unusual Occurrence, which indicated the facility will, "Provide for security of any equipment or supplies that may be needed for future assessment of the situation...to collect information from individuals, chart forms, logs, etc. in order to create a complete chronology of events leading up to the incident,during the incident and following the incident as appropriate."

The investigation was limited to rectifying that the RN's actions were acceptable. The facility didn't provide any evidence that they had sequestered medical information or equipment which could have aided in creating a chronology of events that led to the incident. In fact the facility failed to show that any form of valuable investigation was done at all.

2. Patient 308 was admitted to an affiliated (sister) hospital (Hospital B) on 3/28/12. According to the Intensive Care Unit (ICU) Physician Discharge Summary dated 4/6/12, Patient 308 had, "A long standing history of psychiatric illness and multiple prior suicide attempts." The same H&P noted, "The patient was on a suicide watch, getting checked every 15 minutes. Between these frequent checks, the patient got a hold of a patient gown or a thin cloth that was used as a tie for the gown, tied it around her neck, tied it to a bar support in the bathroom, and lay down, creating essentially a hanging, choking sensation. She was found to be unresponsive and agonal. The code blue was called. She was ambu'd and required jaw thrust in order to ventilate. She was a difficult intubation, but ultimately was intubated and brought to the intensive care unit."
On 4/7/12, according to the psychiatric history and physical (H&P), Patient 308 was transferred back into Hospital B's Geropsychiatric unit on a 5250 (14 day hold) and "Needed a 24 hour sitter. " The plan was to admit to the sister facility's (Hospital A) Mental Health Unit to, "Monitor for safety."
On 4/18/12, according to the Nursing Narrative Notes, Patient (308) was, "Received as a transfer from the Geropsychiatric Unit (Hospital B) at 1430 (2:30 p.m. to Hospital A's MHU) via stretcher and two escorts ...Per Nursing Supervisor, patient placed on 15 (minute) safety checks."
On 4/19/12 at 10:34 p.m., a code blue was called, according to the code blue sheet. Patient 308 was taken to the trauma resuscitative room at 10: 41 p.m. and at 10:43 patient 308 was pronounced dead in the emergency room .
The Nursing Narrative Notes, timed and dated at 4/19/12 4:42 a.m., were reviewed. According to the notes at 10:15 Patient 308 was, "Still in the bathroom and stated she was ok (door to bathroom closed)." At 10:30, "I did not see the (patient) in her room, so I opened the bathroom door and found the (patient) in a sitting (crouching) position in front of the sink, a hospital gown was tied around the soap dispenser above the sink, she did not respond to questions. I called for help and another nurse helped lift the patient up to release the tension, she was lowered to the floor and a code blue was called. CPR was initiated by an RN and when the Code team came to the unit she was transferred to the ER."

The 15-minute Patient Monitoring Log for Safety sheets were reviewed on 6/8/12. The 15-minute checks were not started until 4:45 p.m. on 4/18/12. The 30 minute rounds, done on all patients in the Mental Health Unit, were not started until 4:30 p.m. on 4/18/12, two hours after arrival to the unit.

Further review of the 30-minute round checks, done on all patients in the unit, in comparison with the 15-minute Safety Monitoring checks, indicated the two forms of observation didn't match up. On 4/18/12 at 6:30 p.m., 6:45 p.m. and 7:00 p.m., Patient 308 was noted on the 15-minute Safety Monitoring checks to be in her room awake, however on the 30-minute rounds sheet, Patient 308 was noted to be in the lounge at 6:30 and 7:00 p.m.

On 4/19/12 at 5:30 and 5:45 p.m., the 15-minute Safety Checks indicated Patient 308 was in her room awake, however the 30-minute Rounds indicated Patient 308 was in the dining room at 5:30 and in her room at 6:00 p.m. Both the 15 minute and 30 minute rounds were done by the same CNA.

On 9/25/12 at 6:00 a.m., the facility Mental Health Unit was toured. The Round Sheets and the 15-minute safety check sheets were reviewed. The sheets were incomplete for the previous 30-minute check and the previous 15-minute check. The CNA stated, "I'm late on my rounds."

On 9/27/12 at 11:30 a.m., the Mental Health Unit was entered with Administrative Staff and again the rounds weren't up to the current time. Administrative Staff called the CNA to offer an explanation to the Surveyor. According to the CNA, she was, "Waiting for the patients to come to the dining room."

On 6/19/12 at 2:35 p.m. and 9/25/12 at 6:30 a.m., several staff members in the Mental Health Unit were interviewed related to the policy and practice of patient gowns and their availability to patients in the mental health unit. According to all the staff members, including a Charge Nurse that's worked on the unit for over 8 years, the policy and practice was to keep the gowns locked up.

The Manager of the Mental Health Unit was interviewed on 6/19/12 at 2:45 p.m., and stated she believed Patient 308 may have simply walked into another patient's room and picked up a gown off a bed. The Manager further stated, "There is no policy about locking up the gowns." When questioned why her staff seem to believe the policy and practice was to lock up the gowns, she stated "the gowns are locked up because we keep them with other supplies that need to be locked up." The Manger acknowledged that the facility policy for rounds included, "Direct observation." The Manger acknowledged the staff failed to directly observe Patient 308 on, "The last round" (prior to finding Patient 308 hanging on the soap dispenser in the bathroom). According to the Manager, she thought a correction might be to change the policy so direct observation wasn't necessary in order to, "Preserve patient privacy."

On 9/26/12 at 11:00 a.m. and 9/27/12 at 4:00 p.m., Administrative and Quality Staff were interviewed related to concerns of investigations not being thorough or missing. The Quality Staff had already informed CDPH an RCA was never done on the initial attempt of Patient 308 to hang herself at Hospital B because, "She was discharged ." However, admitted ly the patient was discharged from Hospital B to Hospital A and the same Quality Team was responsible for Hospital A and Hospital B. The Chief of Quality stated, "In retrospect, we probably should have done an RCA on that one."

The concern was raised during that meeting that without thorough investigations of near miss or unusual occurrences the facility was failing to provide a safe environment for the patients it cared for and was missing an opportunity to avoid reoccurrence of the same events.

3. On 7/31/12, the facility self reported an event, which was witnessed by the media. According to the report to CDPH a patient (Patient 309) had been triaged and was waiting in the emergency room (ER) waiting room. The patient left the waiting room and was overheard saying he wanted to kill himself. According to the facility report, the patient was, "Prevented from falling and was not harmed."

On 8/1/12 at 9:00 a.m., CDPH entered the facility, to review the case above. The ER Management Staff was interviewed. According to the ER Manager, Patient 309 was there for "detox" from crystal methamphetamines. The Physician Assistant (PA) triaged the patient. There were no beds in the ER, so the patient was sent back to the waiting room. Patient 309 left the waiting room and went to the 6th floor and was heard threatening to jump. The ER Technician pulled the patient back before he jumped over the rail. ER Management Staff could not access the Electronic Medical Record (EMR). The Chief Nursing Officer (CNO) was notified of the facility's repeated difficulty accessing and printing the EMR.

The EMR was reviewed on 8/3/12. According to the ER SIGN IN SHEET, Patient 309 was there for, "Medical Clearance for sobering services (possible ingestion of "speed" in his trail mix." The patient was signed into registration at 7:12 p.m. with admitting diagnoses listed as, "Psychiatric."

According to the Registration Clerk, interviewed on 8/2/12 at 12:11 p.m., she received the diagnoses from the Triage Nurse. The primary triage assessment was done out front in the waiting area and timed at 7:22 p.m., according to the EMR. The focused assessment was started at 7:58 p.m.

The focused assessment was reviewed with the RN responsible 9 RN 1) on 8/17/12 at 1:00 p.m. The focused assessment included a psychiatric assessment entitled, ED Suicide Risk Screening, which included multiple questions in a check box format, the last of which is, "Suicide ideation/intent/plan or attempt." This was the only question not answered on the focused assessment at 7:58 p.m. According to RN 1, she stated she didn't fill out the last question because, "Right then the patient had to go to the bathroom." She stated she did ask, and the answer was no, but she must have been, "Side tracked," and didn't get back to filling that part out until 11:47 p.m., after the patient had already jumped from the stairwell. According to RN 1, she handed Patient 309 the empty urine container, since he had to urinate, and even recalled him, "Coming back up to the triage door later with the urine bottle."

The Security tapes from the ER were viewed with security several times on 8/16/12 and 8/28/12. Patient 309 was observed leaving the ER with an empty urine bottle from triage at 8:03 p.m., and never returned. The next video was seen from the angle of the 4th floor door at 8:53 p.m., where the local police department had arrived in response to a suicide attempt in the facility's stairwell.

The Physician's Assistant (PA) on duty in the ER that evening, was interviewed by phone on 8/28/12 at 11:38 a.m. According to the PA, the nurses were double triaging that evening. The PA stated she didn't do an exam on Patient 309. She said she may have spoken with him, but didn't get full clarification. The PA stated with any psychiatric patient, "We always ask if the patient is suicidal, and if he is, we would hold him in the internal waiting room and draw lab values." The PA couldn't recall if she had asked the patient if he was suicidal, but stated typically the RN does that.

The Depart Summary, containing a time logged event of triage, was reviewed. According to the Summary, Rapid Medical Evaluation (RME) was requested at 7:55 p.m. The completion time was blank. The H&P Intake was completed at 10:59 p.m. Lab was ordered at 8:01 p.m., canceled at 8:01 p.m., and then completed at 10:01 p.m.

The RN (RN 2) that found Patient 309 in the stairwell was interviewed by phone on 8/16/12 at 1:00 p.m. According to RN 2, she was off duty visiting her father who was a patient at the facility. RN 2 went to her office to grab some paperwork she needed to catch up on and on the way back down the stairwell, upon approaching the 6th floor, she saw someone standing in the stairwell. According to RN 2, Patient 309 was in the stairwell and didn't look right. She stated he looked, "Creepy," and was, "Glaring at me." RN 2 stated she was scared for herself and concerned for the patients. S he backed against the wall and asked him if he was ok. RN 2 recalled he told her, "No, if you want to know the truth, I think I'm gonna jump." According to RN 2, Patient 309 stated, "I've been seen at two hospitals and nobody will help me," and made references to, "Ending it all." RN 2 then stated she made Patient 309 promise not to move and she summoned help by calling the PBX operator. The next thing she saw was the ER Technician and a security officer, and she left.

The ER Technician (ERT 3) was interviewed on 9/4/12 at 3:00 p.m. According to ERT 3, he responded to the call from the PBX operator, saw Patient 309 in the stairwell, where the patient threatened, "Don't come any closer or I'll jump." ERT 3 stated, "We've had a lot of jumpers here, but he was doing it." According to ERT 3, Patient 309 had both legs over the rail and moved his arm up, and was looking down the middle on the stairwell. ERT 3 stated he knew that was, "My chance," and grabbed the patients arm. He stated the patient was hanging there in the stairwell until security and the local police arrived, who helped bring Patient 309 back over the rails to safety. According to ERT 3, Patient 309 then attempted to go under the rails to jump, and seemed, "Mad we saved him."

The Police Officer that responded to the call was interviewed on 8/10/12 at 2:00 p.m., He stated when he arrived in the ER parking lot, he saw a security guard and asked, "Where's the jumper," and recalled security didn't know.

The Security Office at the facility was visited on 8/16/12 at 1:00 p.m. and 8/28/12 at 2:30 p.m. The security reports from the incident were reviewed. The daily log indicated, "At approximately 2055 (8:55 p.m.) I was walking down the hall by the ER when (a police officer) flagged me down and asked where the "jumper" was? I told him I knew nothing about it because our phones weren't working. He said it was on the fourth floor stairwell. I took him there and met (another security officer) who was already there. (Security Officer A) told us the jumper was (in) the stairwell. (Patient 309) was on the stairs talking with (ER technician). As soon as (Patient 309) saw (police officer) he attempted to jump, (ER technician) grabbed him as well as the (police officer). I looked in on them and when I saw (Patient 309) I ran up the stairs to assist. We put him in handcuffs for all of our safety. We escorted him to the internal waiting room ..."

Security Officer A was interviewed on 8/16/12 at 1:00 p.m. Security Officer A confirmed the phones were not working correctly and felt fortunate that the police officer was taken to the correct fourth floor stairwell, as there are two fourth floor stairwells in the facility. Security Officer A confirmed Patient 309 had both legs over the railings and was hanging in the middle of the stairwell by one arm, that ERT 3 was holding.

Several Security Personnel were interviewed and stated they had been having ongoing problems with communication. In this case, one Officer stated he tried to call and notify other Security Members and he couldn't be heard. According to the Security Personnel, they've actually had to use their
VIOLATION: PROVIDING ADEQUATE RESOURCES Tag No: A0315
Based on interview and document review, the hospital's Governing Body failed to provide adequate resources to fully perform all of the functions of a comprehensive QAPI program. The hospital had recently moved to a new building and many QAPI activities were suspended for weeks or months during that period. There was only one meeting of the Patient Safety Committee between April and August and the agenda was limited by poor attendance. Minutes from the Quality Management Committee lacked evidence of investigation of 6 adverse events that were investigated by the Department. Some of the meetings of the Board of Directors and the Board Quality Management Committee were also postponed and those meetings that were held lacked information about the reported events or any investigation of these events. The Director of Quality and Patient safety described a system of poor documentation of QAPI activities. Both she and the Chief of Quality stated that resources for QAPI were stretched thinly. This resulted in a failure of the hospital to investigate five reported serious adverse events, and two additional ones not reported but discovered during the survey, and to make any Performance Improvement efforts to reduce the likelihood of a repeat of these events.

1. The Quality Management Committee meeting minutes were reviewed on 9/25/12 at 10:35 a.m. The minutes for meetings held 6/3/12, 7/11/12 and 9/12/12 were inspected. Many items were discussed such as Code Blue reports, critical care items, tissue review, and review of minutes from other committees. There was no evidence of a discussion of any adverse events, any ongoing investigations into these events, or any discussions of ongoing Root Cause Analyses (RCAs).

2. The minutes for the Patient Safety Committee were reviewed on 9/25/12 at 11:20 a.m. An executive summary from 1/9/12 discussed the results of 3 RCA's from October 2011 and December 2011. In March, 2012, another Executive summary was presented by the Director of Quality and Patient Safety. Again, overviews of statistics were presented but no further investigations discussed since the previous executive summary in January. There was a list of what were identified as important items for discussion to be brought up at the next meeting. The Quality binder contained an agenda page for the April and May meetings. Both were stamped "postponed". The Director of Quality stated at that time that both she and the Medical Officer for Quality were on vacation. The 6/11/12 meeting was poorly attended and limited in discussion, with no mention of the action items from March, or discussion of ongoing or recent events and investigations. The July and August meeting agendas were also stamped "postponed" in support of the move to the new facility.

3. The minutes for the meetings of the Board of Directors (governing body) were reviewed 9/25/12 at 11:50. The September 2011 minutes indicated a review of the Board Quality Committee (MQRC) review from 8/9/11. The October 10 meeting minutes stated that the MQRC review was "tomorrow" and so was not yet available for review. The next minutes were for December 12, 2012 and did not mention the review from October. There was simply a report of Press/Ganey statistics (patient survey). The Agenda pages for July and August 2012 were stamped "cancelled." Therefore, the only mention of the Board of Directors reviewing the Quality information from MQRC was the September 2011 review of the August 2011 information. There was no indication of a complete discussion of MQRC data indicated in the minutes from that time until the survey.

4. The minutes for the BQRC were reviewed on 9/25/12 at 12:00 p.m. The 6/18/12 minutes went into some detail of the items being monitored, such as stroke measures and ED statistic, a patient safety update, and some other statistics. However, no data was presented only a statement or two on each item of the trend. There was no information on a discussion of any adverse events or ongoing RCA's or investigations. Again, the July and August meetings were cancelled.

5. The Chief of Quality was interviewed on 9/26/12 at 1:00 p.m. and stated that two of the Patient safety meetings (April and May) were cancelled because both she and the Medical Director for Quality were on vacation. She was asked if the fact that the hospital was in the midst of a move to a new facility might have lessened the focus on the investigation of adverse events, and she responded "No." In a later statement, she stated that the April and May Patient Safety meetings were cancelled due to vacations (as stated previously), but that the July and August meeting were cancelled due to the move. When asked about documentation of the investigations performed at the unit level for adverse events, she stated that the units could not keep any documentation for legal reasons.


6. On 9/26/12 at 2:50 p.m., the Director of Quality and Patient Safety brought several large boxes filled with paper QRRs. It was clear to the survey team that there was no practical way to review these for completion. The Director used her laptop to bring up a log of reported Quality Review Reports (QRR). A brief scan of the log revealed the case of a patient (116) who attempted suicide 6/27/12. The entry date for the QRR was 8/10/12, six weeks later. At first the Director did not know of the case. She then remembered being called by one of the Quality Nurses about the event but thought she was referencing a previous attempted suicide.The call occurred in August, when the QRR was entered into the system, six weeks after the event. For this reason, another investigation was not begun on this new case. Also, no explanation could be given for the six week delay between the event and the logging in of the QRR. The Quality Nurse involved was interviewed later (see 9/27/12 at 2:55 p.m.) and stated that she never had feedback on cases reported to the director, so she never knew there was no RCA on this case or that there had been a misidentification of the case. The Director also stated that the Qulaity Nurses who reviewed all of the QRR's and either accepted them or passes them on consisted of 2 nurses at the downtown campus, one nurse at the Poway facility who reviewed the QRRs only from that hospital, one at the new campus, and one open position at the new campus. The Director stated that the investigations had to be prioritized due to workload. The Director is expected to be called or emailed for cases involving possible harm.

7. A second case was seen on the log of a patient (117) who reportedly had a hip replacement and then a reopening of the surgery due to a fracture seen on X-ray. Again the Director did not know of the case. Further investigation showed that a Quality Nurse had initialed the QRR as not needing further investigation but no documentation of her findings. Review of the patient record showed that the case was reopened because the prosthesis was not a good fit not because of a fracture. The director explained that the nurses review most of the QRRs and initial if no further investigation is needed. However, they may not document their own review, or may document it minimally. In this particular case, the surveyor had to follow the paper trail in the medical record anew since there was no documentation as to why the Quality Nurse initialed it as complete.

8. On 9/27/12 at 1:35 p.m., the Director of Quality and Patient Safety was interviewed in private by the Physician Surveyor. She stated that the poor documentation of investigations by the staff in the individual units, and by the quality nurses was a problem. She felt that part of the problem was that she was stretched too thin. Another full time employee (FTE) for quality was being sought but her feeling was that the job was not being done properly in lieu of that additional person. She agreed that too much communication was by phone, and not documented, leading to errors and omissions. She strongly indicated the desire to improve on documentation of phone calls and investigations at all levels.

9. Quality Nurse A was interviewed on 9/27/12 at 2:55 p.m. She explained that the input of events for her to look at came from the daily (overnight) nursing report, shift reports from supervisors, the daily census, patient complaints and other sources. However, only events deemed serious by the nursing staff would be called to her or another person in quality. The QRRs would take significant time to reach her. The QRR for a serious event might reach her in "a couple of days," but one less serious may take 3-4 weeks. When she believes an investigation is needed, she will email or call the manager for more information and review the medical record. That is the extent of the investigation by the Quality Nurses. They do not reinterview staff, or interview other staff, or conduct any other investigative actions. Based on her findings, she either initials the QRR as reviewed, or calls the Director if she thinks a Root Cause Analysis (RCA) might be needed. She can also "run things past" the peer review chairman who decides if peer review might be indicated (not documented). In these instances, she does not get feedback on the case, particularly as to whether her investigation was valid. Quality Nurse A stated she spends about half her time on this process and the other half on collection of data for core measures.