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.

ELKHART GENERAL HOSPITAL 600 E BLVD ELKHART, IN 46514 July 30, 2014
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on administrative document review, medical record review and interview, the hospital failed to maintain and follow its policy/procedures due to a lack of documented evidence to indicate that an adverse patient event was investigated and reviewed for 1 of 455 patient events (patient 27) reviewed.

Findings:

1. The policy/procedure Incident Reporting System (approved 2-13) indicated the following: " Incident reports ...are to be checked by immediate supervisor and/or the unit manager or director ...[and] ...the risk manager will conduct RCA (root cause analysis)/Intensive Assessment and report to the Patient Safety Committee ... " The policy/procedure failed to indicate a process or methodology to prioritize the severity of events or indicate the incident report reviewing process including timeframes for review.

2. The hospital Patient Safety Program (approved 2-14) indicated the following: " [The] Patient Safety Steering Committee ...will be responsible for correcting work processes, and procedures that ...ensure prompt reporting of events or situations of actual or potential patient harm ...[and] ...errors identified shall be reviewed to determine their cause, and whether the error represents a system problem, a periodic occurrence, or an isolated event ...corrective action is taken to eliminate the cause of the error ... "

3. The MR for patient 27 indicated on 7-30-14 that a surgical procedure was performed in the interventional radiology procedure room to replace a chest tube that was accidently pulled out during a staff-assisted patient transfer and the MR indicated that patient 27 was transferred to the critical care unit following the procedure.

4. An administrative document dated 6-30-14 regarding patient 27 indicated that no event investigation was initiated until 7-29-14 after the facility was notified of a complaint investigation.

5. During an interview on 7-30-14 at 1055 hours, the oncology unit director A13 indicated they (A13) were on leave at the time of the event involving PT27 and confirmed that they (A13) had not investigated the event after returning to work on 7-08-14 until receiving notice of the complaint investigation on 7-29-14.

6. During an interview on 7-30-14 at 1235 hours, risk manager A2 indicated that the Incident Report System should:
a. send an incident report to the involved unit director or manager for review and investigation
b. send a follow up reminder and response notice after seven days when no response has been submitted by to the director or manager
c. send an escalation notice after ten days to the director or manager and send an update bulletin to the chain of command (COC) supervisor when no response has been submitted.
The risk manager A2 confirmed that the policy/procedure Incident Reporting System (approved 2-13) and Patient Safety Program 2014 (approved 3-14) failed to indicate documentation about incident investigation process including the timeframes for review, the follow up reminder and escalation notice sent to the unit director, or the update bulletin sent to the COC supervisor. The risk manager A2 confirmed that no response was received from the oncology director A13 following a reminder notice sent on 7-08-14 and following an escalation notice sent on 7-11-14 and the risk manager A2 confirmed that no update bulletin was sent to the COC executive director of rehabilitation services A12.

7. During an interview on 7-30-14 at 1255 hours, risk manager A2 confirmed that no investigation of the event involving PT27 had been performed prior to the announcement of the complaint investigation.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based upon document review, medical record (MR) review and interview, the nurse executive failed to ensure that the policy/procedure for medical record documentation was followed and a registered nurse evaluated the nursing care of a patient for 1 of 9 medical records (patient 37) reviewed.

Findings:

1. The policy/procedure Documentation, General Guidelines (approved 4-13) indicated the following: " Patient documentation will accurately and concisely reflect information pertinent to the patient including, but not limited to health problems, treatment provided, and response to care during hospitalization . "

2. The MR for patient 37 indicated an order on 5-22-14 by the attending physician for the wound/ostomy nurse to evaluate and treat multiple skin issues associated with a diagnosis of [DIAGNOSES REDACTED]

3. The MR for patient 37 failed to indicate an entry by the wound/ostomy nurse A8 documenting an evaluation with findings and recommendations in response to an order by the attending physician. The MR indicated a treatment order on 5-22-14 at 0954 hours by wound/ostomy nurse A8 for skin repair cream to bilateral lower legs two times a day and as needed and no other wound/ostomy nurse entries were identified regarding the complex wound tissue characteristics or changes prior to the date of discharge on 6-02-14.

4. During an interview on 7-29-14 at 1545 hours, the director of performance improvement A5 and clinical data manager A4 confirmed that the MR for patient 37 lacked documentation indicating the evaluation with findings by the wound/ostomy nurse A8.

5. The MR for patient 37 lacked documentation indicating that nursing staff performed the skin treatment two times a day on 5-22, 5-23, 5-24, 5-26, 5-28, 5-30 and 6-01-14.

6. During an interview on 8-01-14 at 1020 hours, the director of performance improvement A5 confirmed that the MR documentation failed to indicate that the skin treatment was performed as ordered on 5-22, 5-23, 5-24, 5-26, 5-28, 5-30 and 6-01-14.