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.

CLEAR VISTA HEALTH & WELLNESS 3364 KOLBE ROAD LORAIN, OH Oct. 12, 2018
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on record review and interview, the facility failed to notify the family or responsible party of an injury of unknown origin (A0129); failed to ensure patients were provided care in a safe setting (A-0144); and failed to follow their policy in regard to restraint monitoring (A0175).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe setting.
VIOLATION: PATIENT RIGHTS: EXERCISE OF RIGHTS Tag No: A0129
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the facility failed to notify the family or responsible party of an injury of unknown origin. This affected one (Patient #1) of ten patients reviewed for patient rights. The facility census was 46.

Findings include:

Medical record review revealed Patient #1 was admitted on [DATE] and discharged on [DATE]. Review of the medical record revealed Patient #1 had signed receipt of the Patient's Rights and the admission documents on 08/28/18 at 3:15 AM.

The daily nurse evaluation and progress note dated 09/25/18 at 2:30 A.M. that documented the patient was re-directed multiple times during the shift for fondling his genitals. The documentation further recorded that during provision of care, the state tested nurse aide (STNA) had noted the patient had some dark purple bruising on his genitals, who reported such to the nurse. The nurse's assessment documented that the lower part of the patient's scrotum and his right upper thigh had purple bruising on it. The patient had mild discomfort complaints when the area was touched. The skin was purple and felt soft. The patient was on Coumadin, but denied having bumped the area and stated he didn't know how it got like that. Nursing was to continue to monitor area of bruising. Nursing notes dated 09/25/18 at 1:00 P.M. documented bruising to right upper thigh and groin area, along with bruising to the testicles. Patient #1 voiced no concerns of pain or discomfort, and the certified nurse practitioner (CNP) was made aware

Interview with Staff B on 10/10/18 at 3:43 P.M. revealed the facility had received a complaint recently on 10/02/18 related to an alleged injury of Patient #1.

Interview with Staff B on 10/10/18 at 3:43 P.M. revealed the facility had no internal incident reports related to Patient #1.

Interview with Staff B on 10/12/18 at 12:30 P.M. confirmed the facility was unable to provide any documentation that the family or caregiver was notified of the bruising.

Review of the admission packet revealed the patients are provided the Patient Rights which direct that the patient or family or caregiver have right to be informed of your condition. You have the right to know when something goes wrong with your care.

Review of the facility's policy and procedure titled "Family Involvement", dated 02/22/18, directed it was the policy of the facility to establish and outline which individuals are to be notified during a patient's stay and what circumstances to notify. Paragraph B of the policy directed that at the time of admission and throughout the patient's stay, provided the above criteria are met, family/ caregivers will be involved in the treatment and discharge planning of a patient's care.

This deficiency substantiates Substantial Allegation Number OH 0351.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, record review and interview, the facility failed to investigate an injury of unknown origin and two episodes of elopements. This affected two (Patients #1 and #2) of ten patients reviewed. The facility census was 46.

Findings include:

1. Medical record review revealed Patient #1 was admitted on [DATE] and discharged on [DATE]. Patient #1 was involuntarily admitted to the facility on [DATE] with diagnoses which included bipolar disorder, aggression, poor boundaries, sexual inappropriateness, recent history of stroke and heart attack, hypertension and history of increasing violence and aggression toward others. He was admitted from the emergency department for psychiatric stabilization after police were summoned to the home where the patient was found to have a knife and hammer with him and was choking his wife.

The nurses daily nurse evaluation and progress note dated 09/25/18 at 2:30 A.M. documented that the patient was re-directed multiple times during the shift for fondling his genitals. The documentation further recorded that during care, the state tested nurse aides (STNA) had noted the patient had some dark purple bruising on his genitals, who reported such to the nurse. The nurse's assessment documented that the lower part of the patient's scrotum and his right upper thigh had purple bruising on it. The patient had mild discomfort complaints when the area was touched. The skin was purple and felt soft. The patient was on Coumadin, but denied having bumped the area and stated he didn't know how it got like that. Nursing was to continue to monitor area of bruising.

The nursing documentation dated 09/25/18 at 1:00 PM documented bruising to right upper thigh and groin area, along with bruising to the testicles. The patient voiced no concerns of pain or discomfort, and the certified nurse practitioner (CNP) was made aware.

Review of the STNA daily showering monitoring and flow sheets from 09/19/18 through the patient's discharge on 09/26/18 documented Patient #1's skin was intact.

Interview with Staff B on 10/10/18 at 3:43 P.M. revealed the facility had received a complaint recently on 10/02/18 related to an alleged injury of Patient #1. The facility was currently in the process of investing the allegation. Staff B verbalized the only information the facility had discovered was during medical record review when staff documented bruising on 09/25/18.

Interview on 10/11/18 at 4:55 PM with Staff D revealed the facility had contacted her regarding Patient #1's bruising of the upper thighs and genital areas. Staff D verbalized that she medically managed the patient's Coumadin and laboratory tests for the monitoring of Coumadin therapy and treatment of the patient's cardiovascular diagnoses. Staff D verbalized she saw the patient in the dining room and reviewed his most recent PT/INR which revealed the patient had a spike in INR up to 3.0 and was at the high end of therapeutic for management of cardiovascular disease. Staff D also verbalized the patient was also on Plavix (anti-platelet medication) and the patient would be highly prone to easy bruising based on these medications. Staff D verbalized Patient #1 could easily have bruising to multiple areas included the genital areas secondary to Coumadin usage and that the patient was often difficult to manage due to his refusal and non-compliance with medications coupled with periods of full compliance. She verbalized that the patient's history of fondling his genitals frequently along with the use of Plavix and Coumadin could have led to bruising. Staff D did not evaluate the patient's bruised areas.

Interview with Staff B on 10/12/18 at 12:30 PM confirmed the facility was unable to provide any documentation that an incident report or investigation was conducted for the brusing that was reported by the STNA on 09/25/18.

2. Review of the medical record revealed Patient #2 was admitted to the facility on [DATE] with diagnoses which included major depressive disorder, borderline personality disorder, and history of substance abuse.

The nursing documentation dated 08/02/18 for the 7 P.M. through 7 A.M. shift revealed the patient verbalized she saw the opportunity to elope, so she did.

Review of the facility's unusual occurrence log dated 08/03/18 revealed Patient #2 had incurred an elopement on 08/02/18 where she eloped through the northwest dining room exit door of the adult unit., report pushing past staff members exiting unit at 7:30 P.M. and ending up at the local hospital where she was escorted back to the facility at 7:52 P.M.

Review of the facility's investigative notes only contained interviews with staff who may have witnessed the elopement. The Director of Nursing and Chief Executive Officer (CEO) were aware. A new sign was immediately placed on the ambulance door and staff were instructed not to utilize the ambulance door as an exit. Staff education was to be provided on special precautions and door exits at an all staff meeting scheduled for 08/29/18.

Observational tour conducted on 10/11/18 from 4:04 P.M. until 4:37 P.M. revealed the dining room of the adult unit of the facility had a door which exited the dining room to a hallway with various other department doors as well as a staff identification badge swipe equipped door, which lead to the ambulance entrance. Both these interior doors were equipped with staff identification batch swipe security accesses. The ambulance entrance is not badge swipe equipped and exits directly to the outdoors.

During interview with Staff B on 10/11/18 at 4:39 P.M., a request to see the analysis of the event and a determination of how Patient #2 was able to escape past two locked and badge swipe equipped entry points before reaching the ambulance entrance was made. Staff B verbalized the facility was unable to provide any documentation other than the staff interview statements of witnessing staff and the nursing documentation.

Staff B was unable to provide any documentation or staff sign in sheets that detailed the preventative education against further elopements via the ambulance door.

3. Further review of Patient #1's medical record revealed physician's progress notes dated 09/01/18 that documented Patient #1 had managed to sneak out of the geriatric unit and get onto the adult psychiatric unit.

The record revealed Physician orders dated 08/26/18 to start escape precautions for Patient #1. On 08/30/18 orders were noted to start sexual behavior precautions and start every 5 minute checks. On 09/05/18 orders for 1:1 observation were noted. On 09/06/18 orders read to continue assault precautions, sexual behavior precautions and elopement precautions.

Observational tour conducted on 10/11/18 from 4:04 P.M. until 4:37 P.M. revealed the geriatric psychiatric unit and the adult psychiatric unit are separated by the nursing station. The nursing station was equipped with badge swipe access that lead into a vestibule which included a door directly into the nurses station, a door to the medication room and a door that lead directly to the adult psychiatric unit. The nurses station was also equipped with a wooden half door that opened to the geriatric side only that was equipped with a lock located at the base of the door close to the floor. The door was observed to be approximately four feet tall. Staff B revealed during this tour that it was highly unlikely that any patient would be able to access the wood half door lock at the foot of the door.

During interview with Staff B on 10/11/18 at 4:43 P.M., she was unable to provide any information as to how Patient #1 left the geriatric side of the facility and entered the adult side.

In addition, on 09/22/18 at 6:00 P.M. nursing notes documented Patient #1 was observed sitting outside the facility by another patient who alerted staff. Upon reviewing camera, patient exited the door on the 200 hall and patient was assisted by staff back into the facility without difficulty.

Review of the physician's progress notes dated 09/22/18 documented the patient reportedly escaped from the unit from the door exit that was not locked.

Interview with Staff I on 10/10/18 at 3:25 P.M. revealed she was the charge nurse on duty on 09/22/18 for the day shift. It was lunch time and all patients were in the common room, which serves as the dining room. Another patient, who was seated at the table facing outside, informed the nurse Patient #1 was seated outside the building. Staff I verbalized there was no alarm heard nor did other staff on duty report any sounding of the door alarm.

An email exchange between Staff A and the Administrator, dated 09/22/18 at 12:31 P.M., read "Maintenance Staff C said only way would have opened is if someone would have unlocked it and forgotten to lock it again. The patient could have opened it if leaned on it for 15 seconds and it would have opened but there would have been an alarm. No alarm was heard. The question becomes, why are staff going out of that door? The response to this was correct; there should be no need to unlock."

Interview with Administrative Staff A on 10/11/18 at 7:41 A.M. revealed Patient #1 eloped on 09/22/18 and that she was notified by staff of the elopement. She came to the facility for approximately three hours, from 1:00 P.M. until 3:00 P.M. The doors were locked at that time. Maintenance and the administrator were notified. Staff A verbalized the facility conducted an investigation and was unable to determine when or by who the door was unlocked and that all safety check documentation revealed the door was locked and alarmed.

Interview with Maintenance Staff C on 10/11/18 at 9:11 A.M. revealed that exit doors are routinely checked for operational status. The exit door on the 200 hall, which houses the geriatric psychiatric patients, has never malfunctioned since he has been employed there, which was about one year. The door alarm is activated and deactivated manually with a key. All direct care staff have keys to the door to reset the alarm should it be activated by an exit seeking patient. The door is on a standard life safety code 15 second delayed egress door which lead to an enclosed area with stairs to the nursing home which is not part of the facility and a door that leads directly outside. The door is equipped with a flashing red light which revealed the door was locked and alarmed, a solid red light revealed the door was unarmed and unlocked. The fixed station video camera which monitors the door does not capture the light but only the lower portion of door and captures from about the knees down. Maintenance Staff C verbalized this door was a fire exit door only and should not be used.

Interview with Staff A on 10/12/18 at 7:30 A.M. confirmed Patient #1 eloped from an unlocked exit door that was reportedly monitored for locked and alarmed status by facility staff during hall safety checks. Staff A confirmed the facility was unable to provide documentation that all staff were re-educated on the importance of ensuring this exit door was a fire exit only and that all doors were locked and alarmed at all times for the safety of patients.

Interview with Staff B on 10/12/18 at 9:30 A.M. verbalized she reviewed the video camera footage which captured the nurses station where Patient #1 left geriatric side of the facility to the adult side. The video footage revealed Patient #1 was observed leaning over the wooden half door and unlatched the lock at the foot of the door, entered the nursing station and from there walked onto the adult side of the facility, no nursing staff in the nursing station at the time of this occurrence. Staff B verbalized the facility was unable to provide any documentation of this event.

Review of the facility's policy and procedure titled "Abuse, Neglect and Identification and Reporting", dated 02/22/18, directed that it is the policy of the facility that clinical staff will assess for abuse, neglect, including physical, emotional, and sexual abuse as well as neglect and or exploitation and appropriately handle such case in a manner that respects privacy, dignity and safety. The policy directed at item 2 that signs and symptoms of abuse, neglect or exploitation may include but not limited to, cuts, bruises broken limbs. The policy directed that staff should recognize that any of the above referenced signs in and of itself may not always be a cause of concern of victimization, particularly in the psychiatric setting. Item 18 directed any cases of suspected abuse, neglect, or exploitation shall be internally reported in the facility by submitting and incident report to the director of quality, risk, performance improvement and compliance within 24 hours of discovery of event.

The policy and procedure titled "Incident Reporting", dated 02/22/18, directed that incidents reportable to the compliance director of the facility and chief executive officer are occurrences which include the following, patient to patient involvement such as significant injury, serious threats, consensual and nonconsensual sexual contact, etc. elopement, etc.

Reviewed of the facility's protocol titled "Conducting an Investigation", directed after identification of an occurrence perform a root cause analysis to determine what happened. The protocol directed the staff to review clinical records, diagnostic reports, physician notes, hospital reports, staffing schedules, employee files and or any applicable sources to gain information related to the occurrence being investigated.

This deficiency substantiates Substantial Allegation Number OH 0351.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
Based on record review and interview, the facility failed to monitor a patient while the patient was restrained. This affected one (Patient #6) of ten records reviewed. The facility census was 46.

Findings include:

Review of the medical record for Patient #6 revealed the patient was restrained on 09/19/18 from 11:24 A.M. until 1:20 P.M. The Seclusion/Restraint Observation Flow Sheet contained documentation from 12:00 P.M. until 1:15 P.M. The Flow Sheet lacked documentation of restraint initiation or discontinuation as well as documentation from 11:24 A.M. to 12:00 P.M.

During interview on 10/12/18 at 12:23 P.M., Staff F stated there were three registered nurses in the room with Patient #6 while he/she was restrained. The observation flow sheet was not in the room initially and it was an oversight that the first half hour was not documented on the flow sheet.

Review of the facility's policy, titled "Seclusion and Restraint", revealed the patient will be assessed "at the initiation of seclusion or restraint; then continuously thereafter, documenting any care, findings and observations at least every 15 minutes. The patient's activity, state of arousal, status of circulation, status of respiration, physical and psychological comfort, and readiness for release must be documented. Documentation is completed on the 15-minute Seclusion Restraint Observation Flow Sheet".
VIOLATION: MEDICAL RECORD SERVICES Tag No: A0450
Based on record review and interview, the facility failed to accurately and completely document medical records to reflect the patient stay. This finding affected ten (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10) of ten records reviewed. The census was 46 patients.

Findings include:

Review of the medical records revealed the patient safety checks were documented on the "15 Minute Checks / 1-1 Observation Check Sheet". The Check Sheet contains rows at the top of the page to mark the frequency of checks (15 minute checks, arm's length 1-1 observation, or 1-1 observation) and specific precautions (suicide, elopement, aggression, arson, sexual acting out, fall). In addition the form contains boxes in 15 minute increments from 0000 (midnight) to 2345 (11:45 P.M.) with directions to place a code and initials in each time box. The form contains a list of codes that specify the location and behavior of the patient.

The Check Sheets for all ten medical records reviewed (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10) lacked documentation of frequency of checks ordered and type of precautions ordered at the top of the Check Sheets.

Patient #6's Check Sheet dated 09/19/18 lacked documentation of initials in the time boxes and contained only a dash (-) from 6:15 A.M. through 12:45 P.M. and from 1:45 P.M. through 6:00 P.M. Patients #8 and #9's Check Sheets dated 10/10/18 lacked documentation of initials in the time boxes and contained only a dash (-) from 6:30 A.M. through 12:00 P.M. and from 1:45 P.M. through 6:00 P.M.

During interview on 10/12/18 at 1:15 PM, Staff B stated the expectation was that the 15 minute observation check sheets would have the frequency of checks and type of precautions filled out at the top of the form for all days and patients.

During interview on 10/12/18 at 3:05 PM, Staff A stated the Check Sheets should contain the initials of the staff who completed the observation of the patient.

Review of the facility's policy and procedure titled "Nursing Documentation of Patient Records", dated February 2018, directed the registered nurse (RN) will be responsible for the documentation of one nursing note per shift. The note will summarize medication effectiveness and patients' overall condition to include medical, physical and behavioral assessment. Treatment and related flow sheets data may be documented by all nursing personnel. Family contacts are documented by all staff. Discharge planning information is documented by all staff.