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Based on interviews with family, hospital staff, observation, and review of the medical record, it was determined the hospital failed to maintain a safe environment for an elderly patient who exhibited a significant change in mental status.

Patient # 1 is an 85 year old female admitted to Montgomery General Hospital on 6/24/10 with complaint of abdominal pain. She was placed on a medical-surgical unit for pain control and surgical and gastroenterological workups. On admission she was assessed by nursing as alert and oriented. In an interview with Patient # 1's primary nurse on the 7PM to 7 AM shift, she described the patient as confused, wandering in and out of other patient rooms looking for her husband. She would be placed back in her bed only to be seen wandering the hallway again. Her nurse took her by her side at the nurses' station to monitor her. The patient discussed childhood memories, siblings, cooking, and that she wanted to go home to her husband for whom she was primary caretaker. Patient #1 had received Morphine for pain, Benadryl for complaint of itching, and also Ambien for sleep.

During a phone interview with the surveyors, her primary nurse stated she was worried the patient might fall due to the amount and types of medication received and that is why she observed her at the nurses station for awhile. When the patient would pace the hallway, her nurse tried to assign a nursing technician to accompany her. Despite Patient # 1's significant change in mental status and behavior and the ineffectiveness of the medications administered, this patient was not reassessed. There is no documentation in the medical record provided to describe Patient # 1's behavior as it was described to surveyors via telephone interview.

Patient # 1 was described to the surveyors by her primary nurse and the shift charge nurse as confused. This was while receiving sedating medications. After the change in the patient's mental status and behavior the hospital failed to have the patient assessed or initiate changes to the patient's plan of care to deter a cognitively and physically vulnerable patient from eloping from the unit. The nursing staff on 4 East was not aware the patient was missing until a phlebotomist who was on the unit to draw the Patient # 1's morning labs reported the patient was not in her room.

The hospital failed to maintain a safe environment of care when the patient exhibited significant change in mental status and behavior and was not reassessed; it failed to address the environmental risk to a confused vulnerable patient; the hospital failed to make appropriate changes to the patient's plan of care; it failed to notice the patient was missing and when it was made aware took one hour to notify Montgomery County Police via the non-emergency 311 number and failed to notify the family. The failure to maintain a safe environment of care could have led to serious harm to this patient.

Based on interviews and observations completed on July 21, 2010, it was determined that the hospital's Director of Performance Improvement/Risk Management was not aware of the elopement of the vulnerable adult, which occurred on June 26, 2010. As a result, this adverse patient event was never assessed or investigated.

Patient # 1 is an 85 year old female admitted to the Emergency Department of Montgomery General Hospital on 6/24/10 with a chief complaint of abdominal pain. The patient has a history of hypertension (high blood pressure) and atrial fibrillation (abnormal heart rhythm) for which she has a pacemaker implanted and takes the blood thinner coumadin. Other medications include norvasc, digoxin, lopressor, and multivitamins. The patient resides in a retirement setting where she cares for her ill husband. The patient was admitted to the hospital for pain control, surgical consult, and gastrointestinal workup.

On admission to the medical-surgical floor, Patient # 1 was assessed as alert and oriented. She did complain of pain and received Morphine 2 mg IV at two different times during the day shift and once early in the evening shift of 6/25/10. Per interview with nursing staff, Patient # 1 started wandering out of her room and in to others' rooms. She told them she was looking for her husband and talked of cooking a meal and childhood memories.

The nurse responsible for Patient # 1's care told surveyors on phone interview that she returned the patient to bed multiple times. Eventually she brought the patient out to the nurses station to sit while the RN worked. Patient #1 was administered a sleeping medication Ambien 5 mg orally approximately 11:30 PM. The patient also received Benadryl 25 mg orally for complaint of "itching" around 1:30 AM on 6/26/10. Per interview, the nurse reported none of the medications were effective. Patient # 1 continued to wander the hallways. The charge nurse for the night shift told the surveyors in a phone interview that the nurse responsible for Patient #1 "kept her at her side because the patient was so restless." Patient # 1's nurse stated she put her back to bed around 6:00 AM.

Sometime between 5:30 AM and 6:00 AM a phlebotomist who was there to draw the patient's bloodwork asked where the patient was as she did not find her in her room. It was at this time that staff reports searching for the patient on the fourth and fifth floors. The charge RN went to Security and described the patient. She was told a female fitting that description had walked out the front doors. The hospital grounds were searched by security without success.

In interview, the Nursing Supervisor reported to the surveyors she was informed at 6:20 AM that the patient was missing. She advised staff to call the 311 non-emergency line and report it to Montgomery County Police. At this same time, the patient's daughter was calling the 4 East charge nurse to ask why her mother was at home. Patient # 1 had boarded a bus and walked one mile to her home. She was returned to the hospital by her daughter and the patient's husband.

In interview the OHCQ surveyors were informed that at least three (3) different incident reports were initiated in the hospital's on-line reporting system Soft-Med. Once a report is submitted into the system, it triggers the investigation in to the incident. During the investigation of the SoftMed incident reports, nurses interviewed reported the system will time out if the person completing the report stays on one screen too long or takes too long to write up the incident. One nurse manager reported she writes the incident first in a word document and then cuts and pastes it into the incident reporting system. The day charge nurse and the night primary nurse for Patient # 1 reported in interview that they both filled out occurrence reports describing the incident of 6/26/10. The primary nurse reported having to fill it out twice because the system timed-out on her. Nevertheless, no reports were received by Risk Management.

In further discussions with nursing personnel, it was determined many staff including administration are aware of the problems with the SoftMed system, yet there has been no effort to correct the problems or provide additional training. Since both nurses are "sure" their reports were submitted this presents the possibility that other occurrences have been reported that have not been received by the Risk Management department.

If the reporting mechanism for adverse events is not working properly and staff fails to follow the policy in place for reporting events, the data collected and reviewed by Quality and Risk Management Departments will not be accurate. If there are glitches in the system that are simply gleaned over, the Quality and Performance Improvement departments are not receiving information necessary to maintain or improve processes which effect the care and safety of patients and staff.

Additionally the Nurse Manager for 4 East never followed up on the report, nor did the Administrator on Call who was advised of the elopement by the Nursing Shift Supervisor. There were no nursing progress notes describing the occurrence that may have triggered further investigation.

Hospital staff failed to follow its own policy of reporting adverse events. In the hospital policy and procedure titled Incident Reporting it states the "PI/RM must be notified immediately by telephone (Extensions 8xxx or 8xxx) of occurrences of a serious nature, in addition to submitting an occurrence report.....Only document in the patient's medical record a brief description of the event and actions taken.....". If an Occurrence Report had been submitted, per the policy, an electronic message regarding the occurrence would automatically be sent to the department manager for review. This would have triggered the 4 East Nurse Manager to follow-up with the verbal report she received from staff via phone on 6/26/10.

The Risk Management department was not aware of this Patient # 1's elopement until the OHCQ surveyors arrived to investigate the incident. Multiple processes failed that enabled this oversight of the adverse patient event to occur unnoticed by staff responsible for quality assessment and performance.

Based on a review of Patient # 1's medical record, nursing failed to document any information regarding the patient's absence from the unit and the hospital.

The medical records discusses the patient's confusion in a one line note from nursing, but none of the events leading up to the patient's elopement are documented by nursing. Nursing staff also failed to document any information concerning the patient's return to the unit accompanied by her husband and daughter on 6/26/10 .

On the morning of 6/26/10, a physician documented the patient left AMA (Against Medical Advice), bwhich failed to accurately describe the events surrounding patient #1's elopement. Patient # 1 eloped (escaped) without first discussing her desire to leave with staff. Later the hospitalist's note does provide an assessment of the patient shortly after her return to the facility.

Since there were no documented assessments and few notes documenting the patient's behavior and subsequent elopement the surveyors spoke to multiple disciplines in order to develop a time line of events from the evening of 6/25/10 to the morning of 6/26/10. They reviewed when treatments, i.e., respiratory therapy nebulizer treatments, were administered to pinpoint the last time the patient may have been seen by staff. It was noted that at 3:30 AM on 6/26/10 Patient # 1 had a new intravenous line inserted, however, from the medical record it is not clear whether the procedure was performed or simply documented at that time.

Surveyors requested the Rounding Sheets for June 2010 that are completed hourly on every patient. (Rounding sheets provide information on patient status, pain levels, toileting needs, etc.) The 4 East Nurse Manager reported that she maintains only the current month's recorded sheets, therefore June sheets were not available. When a policy and procedure for the rounding procedure was requested, she stated there was no policy/procedure, that " rounding on the patients was more of an expectation," and that nursing technicians round and document on the odd hours and RNs on the even hours.

The surveyors requested the 4 East staffing assignment sheet for the shift starting 6/25/10 at 7:00 PM and ending at 7:00 AM in order to assess acuity levels of patients (the unit received 3 admissions that night taking their census to 29)) versus the number and level of staff assigned to the unit. The Nurse Manager could not provide that particular assignment sheet reporting to surveyors that is was "missing."

The Plan of Care/Interdisciplinary Rounding record for Patient # 1 was not revised to reflect changes in the patient's assessments, behavior and treatments. There are two dates, 6/24/10 and 6/29/10, where goals and expected outcomes are addressed; there was a third day documented but there is no date identified. Therefore there was no evidence that nursing staff revised Patient #1's plan of care to meet her needs.

Documentation on the medical records failed to accurately reflect all interventions such as the patient's response to medications and the patient's responses to those interventions.

Based on observation, interviews with staff, and review of pertinent documentation it was determined that the hospital did not provide oversight and maintain its equipment for the SoftMed system. Additionally, based on observation and interview with security staff, the hospital failed to take steps to provide video surveillance with an accurate time stamp.

OHCQ surveyors requested to view hospital security surveillance tapes of the morning of 6/26/10 to see if it could be determined what time Patient # 1 left the hospital and through which door she exited. While reviewing tapes around the patient's estimated time of departure, it was observed by the surveyors and explained by security staff that the surveillance time stamp; which read 7:41:23 was actually 5:41:23 since the time stamp ran two hours ahead. The system has been this way "for awhile" due to computer software issues. Security personnel did not know when it would be repaired so that accurate data could be obtained while viewing tapes. When this was mentioned to Administration personnel, they responded they were not aware of the inaccurate time stamp.

If the systems for reviewing adverse events are not working properly and staff fails to follow the policy in place for reporting events, the data collected and reviewed by Quality and Risk Management Departments will not be accurate. If there are glitches in the system that are simply gleaned over, the Quality and Performance Improvement departments are not receiving information necessary to maintain or improve processes which effect the care and safety of patients and staff.