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.

MERCYONE WATERLOO MEDICAL CENTER 3421 WEST NINTH STREET WATERLOO, IA 50702 Feb. 11, 2016
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on review of policies, procedure, hospital documents, video footage, medical record, Performance Improvement Plan, patient and staff interviews the hospital failed to ensure staff had knowledge of the missing person policy and elopement procedure to minimize the risks and opportunities for elopements by patients.

A patient eloped on 1/14/16 from an inpatient Medical Surgical unit. The nursing staff failed to assess and monitor a confused and wandering patient's altered mental status prior to administrating the 2nd dose of a hypnotic medication. (Ambien 10 mg) The nursing staff failed to ensure the patient would remain safe and secure in the hospital.

1. The nurse failed to activate a missing person alert to notify all departments in the hospital that a patient was missing. Failure to activate the missing person alert allowed a confused patient, wearing only a hospital gown and slippers to open an unalarmed, unlocked door, to walk out of the hospital into the outside winter conditions, without any staff being aware the patient was missing from one of the Medical Surgical units, resulted in harm. (Refer to A 144)

2. Failure to ensure the nursing staff initiated and provided continuous monitoring after the patient was found and returned to the Medical Surgical unit, placed the patient at risk for recurrence of the elopement, harm, and potentially death. (Refer to A 144)

3. The administrative staff failed to investigate the root cause of the patient's elopement. Failure to identify the why and how the patient eloped and develop and implement meaningful preventative action plans to prevent recurrence of patient elopements placed all patients at risk for harm. (Refer to A 286)

4. The administrative staff failed to interview the individuals who witnessed the patient's elopement and fall outside of the hospital. Failure to identify all contributory factors, eliminate any risk of a recurrence, develop and implement meaningful action plans if needed to improve processes, staff practices, and patient outcomes placed the hospital patients at risk for harm. (Refer to A 286)



The cumulative effect of these systemic failures and deficient practices resulted in the hospitals inability to assure the provision of care in a safe setting.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on review of policies, procedure, documents, video footage, and staff interviews, the administrative staff failed to evaluate staffs' knowledge of the hospital missing person policy and elopement procedure to ensure staff provided patient care in a safe setting.

Failure to evaluate staffs' knowledge of the hospital missing person policy resulted in 1 staff member LPN (Licensed Practical Nurse) M who did not activate "missing person" alert when 1 of 21 patients (Patient #7) eloped (walked away) from the Medical Surgical unit of the hospital to the outside during winter conditions wearing only a hospital gown and slippers. Failure
to activate the missing person alert resulted in a injury for Patient #7 during a fall. After Patient #7 was found, failure to initiate and provide continuous monitoring for Patient #7 as specified in the hospital procedure placed the patient at risk for recurrence of the elopement, harm, and potentially death.

Findings include:

1. Review of the following hospital policies, procedure, and documents revealed the following information applicable to the complaint investigation:

a. A hospital policy titled, "Patient Rights and Responsibilities" dated 1/14, included in part, "...as a patient...you have the right...to...receive care, consistent with sound medical and nursing practice, in a ....safe and secure environment...be assured of reasonable safety within the hospital..."

b. A hospital policy titled, "Missing Person" with a revision date of 6/2015, gave the following direction to staff: If the missing person cannot be located in the immediate area call the emergency number and state: "Missing Person", give the location, gender, and clothing description. Simultaneously the lead person in each department will perform a thorough search of every department/area. All Missing Person alerts will be summarized by the person in charge of the Missing Person event and submitted to the Safety Officer for review..."

c. A hospital procedure titled, "Elopement Procedure" dated 5/2015, included in part, "...The purpose of this policy is provide optimum protection for the patient's safety...If a patient has eloped during current hospital admission, monitoring will be via continuous direct observation..are considered at high risk of elopement...once the patient is returned to the hospital they will be assigned a Safety Companion to provide direct observation for 24 hours..."

d. A hospital document titled, "Security Department Confidential Incident Number 16-15 Fall Report Narrative" Date 1/15/2016, stated in part, "Type of Incident: Injury/Fall...At 12:04 AM...patrolling the hospital parking lot and witnessed paramedics assisting a patient wearing only a hospital gown...had fallen...Red Cross employee witnessed the patient fall and then received help from the ED...patient was very confused...Paramedics transported the patient into the ED triage room...House Supervisor and the patient's nurse...determined the patient's level of Ambien [Ambien is a nonbenzodiazepine hypnotic medication used for the treatment of insomnia.] was too high...LPN transported the patient back to 3 General Med/Surg unit after the Paramedics determined the patient was not injured. After viewing the video footage, the Security Officer determined the patient walked out of the hospital through the unsecured Chapel entrance door at 12:01 AM and the Paramedics reached [Patient #7] at 12:04 AM..."


2. Review of the staff ID (Identification) tracker report showed the following:

a. On 1/14/16 at 11:24 PM, LPN M entered Patient 7's room and exited at 11:26 PM. At 11:58 PM, LPN M entered Patient 7's room for approximately 3 seconds. Video footage showed on 1/14/16 at 11:38 PM, Patient #7 eloped from the 3rd floor Medical Surgical unit, was walking down the chapel hallway on the 1st floor of the hospital. At 11:54 PM, Patient #7 opened an unlocked, unalarmed door and walked out of the hospital into the outside elements.

b. On 1/15/16 at 12:26 AM, RN (Registered Nurse) T and LPN M entered Patient 7's room. RN T remained in the room for 2 minutes and 39 seconds. LPN M remained in the room for 7 minutes. On 1/15/16 at 12:30 AM, the House Supervisor told LPN M the patient was found outside.

3. The surveyor, along with the Security Manager, viewed the video footage recorded on the hospital's security cameras on the night Patient #7 eloped 1/14/16 at 11:38 PM, Patient #7 wearing only a hospital gown and slippers, and pulling an IV (Intravenous) pole, eloped from the 3rd floor Medical Surgical unit. Patient #7 was walking down the chapel hallway on the 1st floor. At 11:54 PM, the patient opened an unlocked, unalarmed door and walked out of the hospital into the outside elements. The video footage showed the patient attempted to reopen the same door the patient had just exited the hospital from, however, the door was locked from the outside. The patient stood at the door, knocked on the glass, and attempted again to open the door. At approximately 12:02 AM, the Red Cross driver exited the ED, walked towards his parked vehicle in the front of the ED entrance. At 12:02 AM (chapel hallway camera view) the patient walked away from the door. The patient walked south approximately 125 feet then turned towards West 9th Street (A busy intersection running parallel to the hospital.) where the patient fell into a snowbank. At 12:04 AM, a Red Cross driver approached the patient. At 12:05 AM, ambulance staff approached the patient, assisted the patient out of the snowbank, and placed the patient in a wheelchair.

4. During an interview on 2/4/16 at 9:10 AM, LPN M stated, "About 12:15 AM, I left the main nurses station to begin patient rounds. [Patient #7] was not in her room." LPN M then reported not initiating the missing person alert immediately and stated, "No, first we circled the unit."

LPN M reported at approximately 12:30 AM, House Supervisor G called and told her they found the patient outside and asked her to come to the ED." LPN M stated, "I did not complete an elopement risk assessment and I should have. It's the hospital's policy." LPN M reported she did not implement elopement risk precautions and stated, "No, I checked on her often, but I didn't document that in [Patient #7's] medical record."

During a telephone interview on 2/3/16 at 4:00 PM, the Red Cross driver who is not a hospital employee stated, "On January 15th at approximately 12:08 AM when I left the ED I heard a "clatter" over by the hospital chapel entrance. I saw a woman descending the steps from the chapel door entrance dragging a IV stand." The Red Cross driver stated, "The woman was dressed in a hospital gown and slippers. She descended the steps, turned right, and headed towards West 9th Street. She continued on down the sidewalk and then fell into a snowbank. After I saw her fall, I went into the ED and reported it to the receptionist."

During an interview on 2/4/16 at 7:55 AM, EMT (Emergency Medical Technician) H reported on 1/15/16 around midnight being informed someone was outside of the hospital by the chapel lying in the snow. EMT H reported, [Patient #7] wearing only a hospital gown and slippers was placed in a wheelchair and moved into the ED into a triage room where staff placed blankets on the patient. EMT H stated, "The patient appeared to be confused."

During an interview on 2/4/16 at 8:15 AM, EMT I stated, "On January 15th around midnight the ED registration clerk reported that someone was outside lying on the ground by the chapel." When asked how the patient appeared, EMT I stated, "She was in a hospital gown, skid socks, her skin was cold, and her gait was unsteady." EMT I stated, "I knew something wasn't right. She was confused. We brought her into the ED." When asked if a missing person alert was activated, EMT I stated, "We didn't know what floor she was on. Someone in admissions checked her hospital band."

During an interview on 2/4/16 at 8:30 AM, Paramedic J verified that on 1/15/16 at approximately 12:00 AM [Patient #7] was found outside lying on the ground in snow. Paramedic J reported someone in admissions identified the patient had eloped from one of the Medical Surgical units. Paramedic J stated, "I told [House Supervisor G] where we found the patient and that the patient had fallen and was confused."

During an interview on 2/4/16 at 7:25 AM, House Supervisor G reported he was notified the ED staff had found a patient outside in the snow. The House Supervisor stated, "I looked at the census sheets and found the patient was from 3 General."

5. During an interview on 2/2/16 at 11:00 AM, the State Climatologist reported the following frigid weather conditions at the Waterloo airport on 1/14/16 at 11:00 PM. The actual outside temperature was 30 degrees Fahrenheit. The winds were out of the south west at 7 mph (miles per hour). The wind chill was 23 degrees Fahrenheit. At 12:00 AM, the actual outside temperature was 32 degrees Fahrenheit. The winds were out of the west at 10 mph. The wind chill was 24 degrees Fahrenheit. There was 3 inches of snow on the ground.

6. Review of Patient #7's medical record reveled the following:

The medical record dated 1/15/16, lacked documentation from 1:07 AM through 8:45 AM that showed staff provided direct supervision of Patient #7 after the patient eloped and was returned to the Medical Surgical unit, in accordance with the hospital elopement procedure.

7. During an interview on 2/5/16 at 7:30 AM, the Chief Nursing Officer stated, "Once [Patient #7] was back on the unit, the nursing staff should have completed an elopement screen and implemented the elopement rounds every 15 minutes. "

During an interview on 2/5/16 at 8:15 AM, Nurse Manager A stated, "We re-educated the staff during a meeting on 3 General Medical Surgical unit. They should have completed an elopement screen and implemented elopement 15 minute observation tool. They failed to follow the hospital missing persons and elopement policies and procedures."
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on review of hospital policies, documents and staff interviews, the administrative staff failed to follow the hospitals Performance Improvement Plan and polices to evaluate 1 of 1 patient adverse event related to patient elopement for (Patient #7). The administrative staff failed to investigate the root cause and implement meaningful preventative action plans to prevent recurrence of patient elopements. The administrative staff failed to interview the individuals who witnessed the patient's elopement and fall outside of the hospital in accordance with the hospital's policy.

Failure to ensure administrative staff evaluated Patient #7's adverse event, (elopement), interviewed the individuals who witnessed the patient's elopement and fall, collected and analyzed all available data to identify the root cause to prevent reoccurrences of patient elopements could potentially result in the failure to identify all contributory factors, eliminate any risk of a recurrence, develop and implement meaningful action plans if needed to improve processes, staff practices, and patient outcomes. Failure to investigate and analyze the root cause could potentially place the hospital patients at risk for harm.

Findings for review of 1 of 1 patient elopements (Patient #7 on 1/14/16) identified during the complaint investigation include:

1. Review of the following hospital policies, procedures, and documents revealed the following information applicable to the complaint investigation.

a. A hospital policy titled, "Occurrence Reporting" with a revision date of July 2015, included in part, "...Utilizing Occurrence Reports, for the identification and documentation of real and/or potential patient safety issues...to record any unexplained/unexpected event, collect data, and analyze data and initiate appropriate corrective action in order to minimize the potential of recurrence of a same or similar event...An occurrence is defined as any unexpected/unplanned event...which results in real or potential injury to a patient...PREPARATION and PROCESSING...The person who witnesses, discovers or is involved in a patient event...will initiate and/or complete the "Occurrence Report Form" with information from the event...any event determined to be of serious nature and/or serious outcome will be reported...in the Quality Services Department immediately...A separate report should be completed for each event and each type of event..."

b. A hospital procedure titled, "Elopement Procedure" dated 5/2015, included in part, "...Definition...Elopement is when a registered patient is not capable of protecting himself or herself from harm successfully leaves the facility unsupervised and unnoticed and may enter into harm's way...FOLLOW UP...Following an elopement, all associates who were involved in the event will participate in a huddle to determine what immediate actions need to be taken to ensure the safety of the patient and to prevent a reoccurrence. Immediately following resolution of the situation, an investigation will be initiated through the "Code E" process, to determine what events led to the patient's elopement. Based on the findings of the "Code E", the investigation will continue through a Root Cause Analysis...Documentation in the medical record..."

c. A hospital policy titled, "Code E Committee Charter" dated May 2015, included in part, "...The Code E Committee is a Quality Improvement Committee...is to meet within 24-48 hours following discovery of a potential serious safety event, including elopements...PURPOSE...Protect the patient...ensure that further injury does not occur...Authorize appropriate investigation...may include peer review and/or root cause analysis...Take actions necessary to prevent reoccurrence of the incident...INTENDED OUTCOMES...Improved adverse event management...Acceleration of sharing lessons learned..."

d. A hospital document titled, "Performance Improvement Plan" Updated: June 30, 2015, included in part, "...Root Cause Analysis (RCA)...used to study an event retrospectively and is a problem solving method aimed at identifying the root causes of...events...best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms...By directing corrective measures at root causes...the likelihood of...recurrence will be minimized..."

e. A hospital document titled, "Security Department Confidential Incident Report" Date of Incident 1/15/16, Incident Report Number 16-15...Type of Incident: Injury/Fall...Time of Incident 00:01, included in part, "...Location of Incident...Chapel entrance sidewalk...Patient confused..."

f. A hospital document, no title, completed by Security Officer, stated in part, "...follow up investigation...16-15 which is a patient fall...Chapel hallway camera...Chapel hallway is approximately 1 to 2 minutes faster than other cameras...11:38 PM the patient is seen walking down the Chapel hallway...11:54 PM the patient walked out the Chapel entrance doors...12:02 AM the patient walked out of view of the Chapel camera...ED entrance/Ambulance bay camera view...12:01 AM...Patient walking down the Chapel stairs...walked South...turned West towards 9th Street...12:03...driver of Red Cross vehicle exits ED...walked to where patient is on the ground...12:05...Ambulance staff approached patient...placed patient in wheelchair...pushed patient in ED..."

2. During the course of the complaint investigation, the surveyor identified through interviews the administrative staff did not complete interviews with the individuals who found Patient #7 outside of the hospital and witnessed the patient's fall into the snowbank, and the individuals who brought the patient into the ED and discovered the patient eloped from one of the Medical Surgical units in the hospital. In addition, some staff directly involved in the patient's adverse event (elopement) did not complete a "Occurrence Report Form" in accordance with the hospital policy.

a. A hospital document titled, "Incident ID: " Date of Incident: 1/15/16, completed by LPN M (Licensed Practical Nurse) included in part, "...[Patient #7]...Occurrence: Fall...Type of occurrence: Fall outdoors...Patient was found outside ED on the ground...ED staff had looked over patient and no injuries found...Patient denied hitting head or pain...Patient is confused at this time...Does not know why she went outside...ACTIONS...Action ID ...interviewed the associates involved...Leader follow-up...Discussed with involved staff..."

b. During a telephone interview on 2/3/16 at 4:00 PM, a Red Cross driver (who was not a hospital employee) reported he witnessed Patient #7 walking away from the hospital when he saw the patient fall onto a snowbank. The Red Cross driver stated, "It was cold that night and there was snow on the ground." The Red Cross driver went on to state, "No one from the hospital has talked to me about this."

c. During an interview on 2/4/16 at 7:55 AM, EMT (Emergency Medical Technician) H reported on 1/15/16, [Patient #7] wearing only a hospital gown and slippers was found outside the hospital lying on the ground. When asked if any hospital staff contacted him regarding this incident, EMT H stated, "I didn't talk with my supervisor or anybody from the hospital about this. I did not file an incident report or put anything in the patient's medical record."

d. During an interview on 2/4/16 at 7:25 AM, House Supervisor G stated, "No one from the hospital has talked with me about this. I did not file an incident report. I reported the incident to the next shift House Supervisor." House Supervisor G then stated, "I did not document anything in the patient's medical record. As a house supervisor, I am not responsible for that. The floor nurse would be responsible."

e. During an interview on 2/4/16 at 12:25 PM, the ED Nurse Manager stated, "I wasn't aware of this incident until yesterday (2/5/16) when [Chief Nursing Officer] told me you were here investigating an inpatient that went outside."

3. During the course of the complaint investigation, the surveyor identified through interviews and review of documents, the administrative staff did not investigate the root cause of how the patient eloped from the Medical Surgical unit. The administrative staff identified Patient #7's adverse event as a patient fall instead of a patient elopement that resulted in the patient's fall. The administrative staff did not perform an analysis of how and why the patient eloped, or to identify potential risks of patient elopements throughout the hospital. The administrative staff did not develop and implement meaningful action plans to prevent recurrence of patient elopements.

During an interview on 2/5/16 at 7:00 AM, the VP (Vice President) of Medical Affairs stated, "The minute 3 General staff identified [Patient #7] was missing, they should have activated our missing person alert. This was identified in our initial Code E Safety debriefing. It was a clear defect. We instructed [Chief Nursing Officer] to go back and instruct staff."


During an interview on 2/9/16 at 4:25 PM with the VP of Medical Affairs, Risk Manager, and Chief Nursing Officer, the VP of Medical Affairs reported a Code E meeting was held on 1/18/16 (3 days after Patient #7's elopement). The Risk Manager reported [Nurse Manager A] on 3 General Medical Surgical unit completed an investigation and conducted a meeting with the staff on 3 General Medical Surgical unit. The VP of Medical Affairs stated, "There were no policy changes because if staff had followed the policy and procedures for elopement precautions and missing persons, we would have mobilized additional resources and might have prevented the patient from getting outside in the first place." When asked if there were any additional interventions put in place, the VP of Medical Affairs stated, "It was just re-education to staff. The understanding of the missing persons alert prompts a response from all departments."

4. A hospital document titled, "Wheaton-IA Safety Event Checklist" (E-Meeting documentation) Dated 1/15/16, included in part, "...Event...FALL...[Patient #7] received Ambien 10 mg (milligrams) [Ambien is a nonbenzodiazepine hypnotic used for the treatment of insomnia]...received second dose 10 mg...was walking the floor until she was sleepy...security notified at 00:04...missing person not called..."

A hospital document titled, "January 14th - 15th 2016 Events" no date, completed by Nurse Manager A, stated in part, "[Patient #7], admitted on [DATE] was not considered a fall risk. The patient was alert, oriented, and up ad lib (As one desires). The patient received Ambien 10 mg (milligram). At 11:24 PM the patient received a second Ambien 10 mg. The nurse reported around midnight she did not find Patient #7 in the patient's room. At that time, the nurse asked her co-workers to help look for Patient #7. The nurse received a call from Security about a missing person and the patient was found and taken to ED for an evaluation. The nurse notified the patient's physician and family regarding the events..."

5. During a interview on 2/10/16 at 3:30 PM with the VP of Medical Affairs, Risk Manager, and Chief Nursing Officer, the VP of Medical Affairs stated, "We did not consider it as an elopement because she did not leave the hospital grounds."

The Risk Manager stated, "Primary reason she got outside was because staff didn't follow the missing persons policy and procedure."

The Risk Manager stated, "Elopement means when someone leaves treatment and then they are gone from the hospital. We considered this as a patient's fall and I think it was appropriate."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on review of policies, procedure, hospital documents, video footage, medical record, and patient and staff interviews the hospital failed to ensure to schedule an adequate number of licensed nursing staff to provide safe patient care, to assess and monitor patients, and to minimize the risks and opportunities for elopements by patients.


1. Failure to schedule an adequate number of licensed registered nurses and licensed practical nurses to monitor and assess patients allowed a confused patient, who wandered the hallways after receiving a 2nd dose of a hypnotic medication (Ambien) to elope from a 3rd floor Medical Surgical unit. The confused patient walked to the 1st floor chapel hallway, opened an unalarmed, unlocked door, and exited to the outside of the hospital into winter weather conditions. Failure to ensure the Medical Surgical unit had an adequate number of licensed staff to provide safe patient care placed all patients at risk for elopement and harm. (Refer to A 392 and A 395)

2. Failure to ensure nursing staff monitored and assessed a patient with signs and symptoms of altered mental status (confusion), after the patient eloped from the hospital, was exposed to outside winter conditions for an unknown period of time, and had sustained a fall, placed the patient at risk for adverse outcomes. (Refer to A 395)



The cumulative effect of these systemic failures and deficient practices resulted in the hospitals inability to provide adequate numbers of nursing staff with knowledge to provide safe patient care.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on policy review, document review, staff interview the hospital administrative staff failed to schedule an adequate number of licensed registered nurses and licensed practical nurses to provide safe patient care as needed for 1 of 1 nursing staffing shift reviewed. (6:30 PM to 7:00 AM on 1/14/16 - 1/15/16).

Hospitals are required to ensure that adequate staff is available to ensure patient's needs are met and to reduce the risk of patient harm. Failure to ensure the hospital scheduled an adequate number of licensed registered nurses and licensed practical nurses to provide safe nursing care to all patients resulted in 1 of 21 patients reviewed eloped during the nursing shift reviewed. (Patient #7)

Findings include:

1. Review of a hospital policy titled, "Patient Care Overview" with a revision date of 11/14, included in part, "...Staffing Plan is designed to provide for the delivery of quality patient care...developed in accordance with our regulatory standards, practice standards and standards of care... adjustments are made based on...patient acuity, work load, and the number of qualified...personnel scheduled for the...shift..."

2. Review of a hospital document titled, "Unit Structure and Practice Model - Acute Care Units" dated 12/14, included in part, "...the acute care units are located on second, third, fourth and fifth floors...provide quality care to adult medical/surgical patients...provide a safe environment...staffing guidelines are based on patient census and acuity...our responsibility is to provide adequate staffing to meet the needs of our patients to provide excellent care...the following are guidelines to consider prior to instituting the High Census Policy: ...when the census is consistently 35% or more above budgeted levels...when staff availability is limited...the Agency In-house Staffing Program is a strategy to maintain appropriate staffing levels based on the needs of the organization..."
Review of a hospital document titled, "Daily Roster - 3W General Acute Care" dated January 14, 2015 showed on 1/14/16 at 6:30 PM, 2 registered nurses and 1 licensed practical nurse began their assigned shift and ended their shift on 1/15/16 at 7:15 AM.

Review of a hospital document titled, "Station Census-3 General" included in part, "...21 patients.."

Review of a hospital document titled, "January 14th - 15th 2016 events" no date, completed by Nurse Manager A, 3 General Medical/Surgical unit, included in part, "...This was not a typical night for staffing. We had 2 floor nurses (RN's) Registered Nurses and 1 (LPN) Licensed Practical Nurse each carrying 7 patients...with 1 RN orienting...Due to tight staffing one of the day nurses stayed over to assist staff with the first part of the evening to assist with medication pass...We decided...offer staff agency hour to assist with the high census..."

3. During an interview on 2/4/16 at 9:10 AM, when asked if LPN M was responsible for Patient #7's cares on 1/14/16, LPN M stated, "I floated to the unit because they were short staffed that night. I was assigned [Patient #7] and 6 other patients. It was a very busy night." When asked if LPN M could explain how Patient #7 eloped, LPN M stated, "There is nothing to stop patients from getting off the unit. There was three nurses for twenty-one patients. We are not always sitting at the nurses station."

During an interview on 2/5/16 at 8:15 AM, Nurse Manager A from 3 General Medical Surgical unit stated, "This was not the first time [LPN M] floated from 2 General Medical Surgical over to 3 General Medical Surgical." Nurse Manager A then reported, a nurse and a CNA (Certified Nurse Assistant) called off that night and stated, "Staffing levels were short that night. Normal ratio is one nurse to five patients." Nurse Manager A stated, "The RN had to oversee [LPN M's] patients so that meant the RN had fourteen patients on that night." Nurse Manager A stated, "We budget for fourteen patients but we have been between eighteen to twenty patients. For the past six months there has been a big fluctuation in census. The patient census is higher than what we are budgeted for." Nurse Manager A stated, "I do think that this contributed to this event."
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
I. Based on review of policies, procedure, documents, medical records, and patient and staff interviews, the administrative staff failed to ensure nursing staff assessed patients prior to and after the administration of hypnotic medications

Failure for nursing staff to assess patients prior and after administering hypnotic medications to assure patients were aware of the patient's surroundings and would remain safe and secure in the hospital resulted in 1 of 21 patients (Patient #7) eloping from one of the Medical Surgical units after the patient received a second dose of a hypnotic medication. The patient left the hospital and went outside during winter conditions wearing only a hospital gown and slippers. The patient was found outside and taken to the ED (Emergency Department).

Findings include:

1. Review of hospital policy, "Assessment of Patient" dated 2/14, included in part, "...Information from various assessments help staff identify and assign priorities to care needs...each patient is reassessed as necessary based on...changes in his or her conditions...ongoing/focused assessments occur: ...when patient condition changes or has a potential to change."

2. A hospital document titled, "Care Notes System Wheaton Franciscan Healthcare - Zolidem Brand Name Ambien" included in part, "...Possible side effects...anxiety...nervousness...unusual behavior...severe confusion...memory loss..." The Chief Nursing Office reported the Care Note System is available for nursing staff to use with medication administration.

A hospital document titled, "Mosby Patient Care Standards" available to nursing staff on the 3 General Acute Unit, included in part, "...Sleep Pattern Disturbance...interventions...control environmental... provide comfort measures...assess any sleep medications for effectiveness, encourage patient to express anxieties that may prevent or disrupt sleep."

3. During the course of the investigation, the surveyor identified through interviews with staff and the patient and review of the patient's medical record and hospital documents, the nursing staff were aware Patient #7 exhibited signs and symptoms of anxiety, confusion. Patient #7 entered an empty room and continued to wander in the halls after the patient received 2 doses of a hypnotic medication. (Ambien 10 mg/milligram) [Ambien is a nonbenzodiazepine hypnotic medication used for the treatment of insomnia.]

a. During an interview on 2/4/16 at 9:10 AM, LPN M stated, "At 8:18 PM Patient #7 received Ambien 10 mg. The next time I saw [Patient #7] was around 11:00 PM. The patient wanted another dose of Ambien." When asked if LPN M tried other interventions, LPN M stated, "No, the room was already dark and [Patient #7] appeared anxious, fidgety, and worried." When asked if LPN M reported Patient #7's behaviors to the physician, LPN M stated, "I told him, she was anxious." LPN M stated, "I gave [Patient #7] the second Ambien 10 mg at 11:24 PM." When asked when she realized Patient #7 was missing, LPN M stated, "About 12:15 AM, I left the main nurses station to begin patient rounds. [Patient #7] was not in her room." When asked if LPN M called a "missing person", LPN M stated, "No, first we circled the unit and at approximately 12:30 AM we went to the main nurses station to call the "missing person" and I received a call from the House Supervisor and [Patient #7] was in the ED because they had found the patient outside."

b. During an interview on 2/4/16 at 11:40 AM, PCA R stated, "I saw the patient wandering in the hall and then she walked into an empty room. The patient looked a little messed up. I told the patient she was in the wrong room. I then showed the patient where her room was." When asked what PCA R meant by the words "messed up", PCA reported the patient and other patients were confused and needy. When asked if PCA reported her observations to the nurse, PCA stated, "I told [LPN M] the patient went in the wrong room and right after that the patient was gone."

c. Review of the Nursing Note, dated 1/14/16 at 8:18 PM, completed by Staff M, LPN M, revealed Patient #7 received Ambien 10 mg. The medical record lacked documented to show LPN M tried alternative interventions to assist Patient #7 with the difficultly in sleeping.

d. Review of Nursing Note, dated 1/14/16 at 11:23 PM, completed by LPN M revealed, Physician A gave an order for Patient #7 to receive a second dose of Ambien 10 mg. The nursing note lacked documentation that reflected any nursing assessment and physician notification of Patient 7's adverse response to the hypnotic medication administered at 8:18 PM, such as observations of Patient #7 anxious, fidgety, and appearing worried.

4. During an interview on 2/2/16 at 11:52 AM, Patient #7 stated, "I thought I was dreaming and all of a sudden I was outside and it was really, really cold. I was dragging my IV pole." When asked if the patient remembered asking for additional medication, Patient #7 stated, "I don't remember anything after the first Ambien. I don't remember asking for the second one. I have no memory of what happened. [Physician A] told me the next morning they had made a mistake by giving me two Ambiens. When asked if she sustained any injuries, Patient #7 stated, "When I got home, I noticed bruises on my right side, from my breast to my hip. I fell dragging my IV pole. I thought it was another patient. I do remember being outside and someone yelling at me. I wish I could fill in the blanks." When asked if she remembered anything else, Patient #7 stated, "My concern is I don't know how I got outside without anyone noticing. It was cold."
During an interview on 2/4/16 at 1:00 PM, Physician A stated, "She has been taking Ambien for years" Physician A stated, "I would expect the staff to monitor her like they would normally monitor any patient that is given a hypnotic medication." Physician A stated, "I don't have a whole lot of information beyond my dictation."

During an interview on 2/5/16 at 8:15 AM, Nursing Manager A stated, "Nursing staff on our unit would be re-educated to offer diversions activities instead of administering a second dose of Ambien 10 mg such as a warm shower, talk with the patient, hold the patient's hand, and/or music."


II. Based on review of hospital policies, medical record, and staff interviews, the hospital failed to ensure nursing staff monitored and assessed a patient with signs and symptoms of altered mental status (confusion), after the patient eloped from the hospital, was exposed to outside winter conditions for an unknown period of time, and had sustained a fall.
Failure to ensure the nursing staff examined Patient #7 who exhibited signs and symptoms of altered mental status (confusion) after the patient eloped and was exposed to winter conditions (32 degrees Fahrenheit with a wind chill of 24 degree Fahrenheit) and sustained a fall could potentially place the patient at risk for adverse outcomes.

Findings include:
1. Review of hospital policy, "Assessment of Patient" dated 2/14, included in part, "...Information from various assessments help staff identify and assign priorities to care needs...each patient is reassessed as necessary based on...changes in his or her conditions...ongoing/focused assessments occur: ...when patient condition changes or has a potential to change."

2. Review of Patient #7's medical record revealed a discharge summary, on 1/15/16 at 8:06 AM, completed by Physician A included in part, "...[Patient #7] did have some sleep walking and actually left the hospital in a state of sleep...was found by security and returned to...bed..."

3. During an interview on 2/4/16 at 7:25 AM, House Supervisor G reported the ED physician did not examine the patient. House Supervisor G stated, "The ER doctor is for outpatients and she was an inpatient." When asked if he knew the patient fell outside, House Supervisor G stated, "I did not know she had fallen or how long she was outside. Should I have checked to see if the patient had visible signs of injuries, yes."

During an interview on 2/4/16 at 7:55 AM, EMT H stated, "I don't think anyone saw [Patient #7]. I don't know why. I didn't report this to the ED doctor." EMT H stated, "I have never had this situation come up before. The patient wasn't shivering and did not go in and out of consciousness."

During an interview on 2/4/16 at 8:15 AM, EMT I stated, "I knew something wasn't right. She was confused." When asked if Patient #7 showed any signs of a injury, EMT I stated, "She was still confused. I did not see any obvious injuries but again her skin was cold. She was in minimal clothing, it was very cold outside and I did not know how long she was outside. I took a temporal temperature. It was about 97 degrees." EMT I stated, "I don't recall anyone assessing the patient in the ER triage room."

During an interview on 2/4/16 at 8:30 AM, Paramedic J reported after [Patient #7] was found outside and brought into the ER he told [House Supervisor G] where they found [Patient #7] and that the patient had fallen and was confused.
During an interview on 2/4/16 at 8:55 AM, the Manager of Ambulance Services stated, "The House Supervisor on that night was responsible to provide direction and guidance to the EMT's and Paramedic staff. In my opinion, a patient should be assessed. Obviously to make certain the patient is stable."

During an interview on 2/4/16 at 9:10 AM, LPN M stated, "I don't know if the patient was examined by the ED doctor. We don't always have a doctor examine a patient after a fall. I don't know if there was a doctor with the patient in the ED. I didn't check." When asked if the patient had injuries, LPN M stated, "The patient said she did not have any injuries but the patient was confused." LPN M stated, "I got her back on the unit at 12:45 AM and everything was normal other than the patient's mental status. It had changed from the first time I saw the patient." When asked to describe Patient #7's altered mental status, LPN M stated, "She was confused. The patient didn't know that she had been outside." When asked if LPN M notified Physician A of the patient's altered mental status, LPN M stated, "I told him the patient had been outside."

3. Nursing note, dated 1/15/16 at 1:07 AM, completed by LPN M, showed LPN M documented Patient #7 had a period of confusion. Further review lacked nursing documentation from 1:07 AM through 8:45 AM, regarding a nursing assessment reflecting Patient #7's altered mental status, temperature, blood pressure, and respirations.

During an interview on 2/4/16 at 1:00 PM, When asked if he was notified of Patient #7 elopement, Physician A stated, "Yes, this is the first time in 18 years." Physician A stated, "I examined her the next morning. There were no injuries and no bruises."


During an interview on 2/5/16 at 7:00 AM, the VP (Vice President) of Medical Affairs stated, "Ideally, she would have been seen by a physician to see if she was hypothermic, a neurological exam for confusion, disoriented, vital signs (Temperature, blood pressure, heart rate, and respirations.) and evaluated for injuries." The VP of Medical Affairs stated, "Someone who has been outside for an undetermined amount of time it is a physicians clinical judgement. Since they were not aware of how long she had been outside, evaluate her to see if she is confused from the medicine or if there is something else going on." The VP of Medical Affairs stated, "The fact that she had fallen and why she had gone outside in the first place. There should of been a physician assessment."

During an interview on 2/2/16 at 4:25 PM, the Chief Nursing Officer verified Patient #7's medical record lacked documentation of a nursing assessment and/or a physician examination after Patient #7 eloped. When asked for an policy and procedure relevant to patient exposure to frigid temperatures for an unknown amount of time, the Chief Nursing Officer stated, "We do not have a specific policy and procedure but obviously she needed to be assessed or checked by a physician for injuries."