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UNIVERSITY OF WI HOSPITALS & CLINICS AUTHORITY 600 HIGHLAND AVENUE MADISON, WI 53792 Aug. 12, 2020
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and interview the facility failed to ensure that grievances are investigated and complainants are informed of the investigation steps taken to investigate grievance and the results of that review as per facility policy in 1 of 13 (Patient #1) medical records reviewed out of a total universe of 13.

Findings include:

The facility policy titled "Responding the Patient/Family Complaints and Grievances" #1.3.3 effective date 10/20/2017 was reviewed. This policy revealed "B. Grievance is the expression by a patient or the patient's authorized representative regarding dissatisfaction with any aspect of their care or service that cannot be promptly addressed by the staff or management present. Grievances also include: ii. Anytime the patient or the patient's authorized representative requests their issue be handled as a formal grievance or requests a formal response from the organization. iii. Written correspondence regarding dissatisfaction with patient care is generally handled as a grievance...POLICY ELEMENTS: It is the policy of UW Health in accordance with state and federal regulations, to respond promptly and thoroughly to any patient complaint or grievances made against UW Health, its employees, or members of the medical staff. UW Health informs each patient of the right to file a grievance in accordance with federal and state regulation...The Patient Relations Department, in consultation with the Grievance Committee, is the official channel for the review and resolution of patient or family complaints/grievances about the quality of patient care or service received anywhere within UW Health. Patient Relations staff will work with the appropriate manager to investigate the issues identified and resolve them whenever possible. The Patient Relations Department is also responsible for notifying management and administration of serious complaints, grievance, and trends. Generally, grievances are considered resolved when the patient is satisfied with the actions taken on their behalf. PROCEDURE: C. Responding to Patient/Family Grievances ii. For grievances that arise after an episode of care or when it is not necessary for Patient Relations to get involved immediately. c. The Patient Relations Department and the appropriate medical staff/manager/administrator will investigate and develop a written response to the grievance. g. Whenever possible a patient's grievance will be addressed in writing within 7 business days of the receipt of the grievance. If the grievance will not be completed within 7 days, the patient or the patient's representative will be informed that their grievance is still under review. They will also be advised of the estimated timeframe for completion of the review and written responded. UW Health staff and faculty strive to resolve and respond to grievances as soon as possible. h. All written responses to patients/families about grievances must be reviewed by the Patient Relations Department prior to mailing the letter to the patient/family. The written response will include the steps taken to investigate the patient's grievance, the results of that review, the date and the name of the hospital contact persons(s)."

Patient #1 was admitted on [DATE] for surgery on a left temporal [DIAGNOSES REDACTED] removal procedure and post operative days were progressing as expected. On 4/27/2020 Patient #1 was to be discharged to home and family was coming to pick up. Staff attempted preauthorization of anti seizure medication Vimpat and found out it would cost $375 out of pocket per month for Patient #1. Advanced Nurse Practitioner B consulted with Neurosurgeon A and it was decided to order Phenytoin/Dilantin for seizure prevention. A "loading dose" to be given intravenously (IV) was ordered to be given prior to discharge and discharge on an oral dose. Phenytoin/Dilantin was documented as started as a secondary IV line at 3:33 PM. After medication had been infusing 15 minutes Registered Nurse C returned to Patient #1's room to see how he/she was doing. Registered Nurse C found Patient #1 unresponsive and slumped over to left side of the chair. Registered Nurse C shook Patient #1 twice to awaken him/her and in doing so Patient #1 hit the left side of their head on the bedside table. The IV medication was stopped and one set of vitals were obtained.

Patient #1's daughter contacted the unit charge nurse the same day of the adverse occurrence (4/27/2020) and first contact made with Patient Relations with complaints of adverse occurrence documented on 4/28/2020. The official "grievance" according to the facility was initiated on 5/11/2020 when Director of Patient Relations K spoke with Patient #1 about care received at the facility. On 5/31/2020 Director of Patient Relations K sent an email to Patient #1's daughter that revealed "I'm touching base to let you know that we are continuing to review the concerns you and your mother brought to our attention and the request for compensation. The review will take several more weeks to complete." Additional emails were sent on 6/11/2020 and 6/19/2020 stating there would be more required time for investigation into the grievance needed.

An interview was conducted with Director of Patient Relations K on 8/12/2020 at 1:14 PM who, when asked about the 20 days between notification to complainant of needing more time for investigation into their grievance stated, "The conversation I had with [Patient #1 and daughter's name] on 5/11/2020 included that our review of their concerns would not be concluded in 7 days and it would take approximately 45 days. They both said they understood so I did not send a templated letter."

A letter was completed and sent to Patient #1 by Director of Patient Relations K on 6/23/2020 that revealed "I am writing in response to the complaint and demand for compensation your daughter made on your behalf to [facilities name] regarding the care you received during your recent admission for removal of a left temporal [DIAGNOSES REDACTED]. A thorough review of your care for dates of service 4/23/2020 through 4/30/2020, including the phenytoin administration, was completed. In summary, you underwent a craniotomy for resection of a left temporal [DIAGNOSES REDACTED] on 4/24/2020. Postoperatively you did well. On 4/27/2020, prior to planned discharge, phenytoin was prescribed for seizure prophylaxi. Phenytoin was recommended because you had an adverse reaction to Keppra in the past and there was a large out of pocket expense for Vimpat. During the Phenytoin administration, you unfortunately had an adverse reaction and were unable to be discharged as planned until further diagnostics were completed. We are sorry you had this experience and understand your symptoms caused concerns for you and your family. In regard to your request for compensation, we are unable to meet your request as the symptoms you experienced were a result of a complication."

An interview was conducted with Director of Patient Relations K on 8/12/2020 at 3:13 PM who, when asked why the letter to the complainant did not document the steps taken by the facility to investigate the patient's grievance and results of that review replied, "In cases where we will be providing detail to regulatory bodies in response to outside complaints, our response tends to have less detail (this is on recommendation of our Legal Department)."

There was no documented investigation completed by the unit manager and no communication of the steps taken to investigate the patient's grievance and the results of that review to the complainant as per facility policy.
VIOLATION: CONTENT OF RECORD Tag No: A0449
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on record review and interview the facility failed to ensure the complete documentation of patient assessments, neuro checks, vital signs, rate and amount infused of IV Dilantin, managements' investigation into occurrence and root cause analysis following an adverse drug reaction as per facility policy in 1 of 13 (Patient #1) medical records reviewed out of a total universe of 13 medical records.

Findings include:

The facility policy titled "UW Health Medical record Documentation" #6.15 effective date of 7/1/2015 was reviewed. This document revealed, "2. Progress Notes: a. Progress Notes should give a pertinent chronological report of the patient's course in the hospital and reflect any change in condition and the results of the treatment."

The facility policy titled "Administration of Medications" #6.1.18 effective date of 10/16/2019 was reviewed. This document revealed "A. General. ii. The person administering the medication is responsible for ensuring documentation of administration in the patient's medical record has occurred."

The facility policy titled "Sentinel Event Determination and Event Reporting" #1.3.2 effective date of 2/19/2020 was reviewed. This document revealed "I. PURPOSE: To identify areas of system vulnerability, adverse events and improve patient and staff safety by encouraging proper reporting and investigation of any event resulting in or having the potential to result in harm to a patient, visitors or staff member including unsafe conditions. Additionally, to facilitate review by interdisciplinary teams to ensure patient and staff safety outcomes, compliance with requirements for liability coverage and to address accreditation requirements for the review and analysis of sentinel events. II. DEFINITIONS: Event Evaluations Teams: Teams are multidisciplinary and responsible for facilitating further review of events with the goal of assuring issues are addressed by the appropriate administrative unit(s) that can most effectively identify opportunities for system performance improvement. Make determinations for events that require a Root Cause Analysis (RCA), including Serious Safety Events and Sentinel Event status as defined by The Joint Commission (TJC). IV. PROCEDURE: i. Any staff member suspecting an event has resulted or has the potential to result in harm to a patient, visitor or staff member, should report the event electronically via the organization event reporting system. Examples of reportable events include: c. Medication errors or medication safety concerns. v. For adverse events that require medical attention: b. A description of the event, treatment provided and the patient's response to treatment should be documented in the electronic health record. B. Manager Review/Follow-Up of Submitted Events Reports:ii. All event reports require follow-up by the manager(s) and should be part of their leader standard work. a. Best efforts should be made to review an event report within 72 business hours of submission to determine report severity, accuracy and completeness. b. Best efforts should be made to document follow-up finding on the Manager Review for Event page within 30 days of submission. vi. Managers should work with their physician partners where applicable to: a. Identify and remedy system issues; b. Share events and system issues with their staff to promote awareness, performance improvement and to improve safety."

Patient #1 was admitted on [DATE] for surgery on a left temporal [DIAGNOSES REDACTED] removal procedure and post operative days were progressing as expected. On 4/27/2020 Patient #1 was to be discharged to home and family was coming to pick up. Staff attempted preauthorization of anti seizure medication Vimpat and found out it would cost $375 out of pocket per month for Patient #1. Advanced Nurse Practitioner B consulted with Neurosurgeon A and it was decided to order Phenytoin/Dilantin for seizure prevention. A "loading dose" to be given intravenously (IV) was ordered to be given prior to discharge and discharge on an oral dose. Phenytoin/Dilantin was documented as started as a secondary IV line at 3:33 PM. After medication had been infusing 15 minutes Registered Nurse C returned to Patient #1's room to see how he/she was doing. Registered Nurse C found Patient #1 unresponsive and slumped over to left side of the chair. Registered Nurse C shook Patient #1 twice to awaken him/her and in doing so Patient #1 hit the left side of their head on the bedside table. The IV medication was stopped and one set of vitals were obtained. There was a complete assessment on Patient #1 at 8:00 AM 4/27/2020, one set of vital signs at 3:58 PM then the next assessment was documented at 8:00 PM (4 hours after adverse occurrence).

There was no documented patient assessment, neuro checks, recheck of vitals, documented time of IV medication being shut off, amount infused or the rate at which it was infusing, unit management investigation into occurrence or sharing of events and investigation with unit staff.

An interview was conducted with Unit Manager H on 8/4/2020 at 10:45 AM who, when asked, about their investigation into the adverse drug reaction stated "I didn't do one."

An interview was conducted with Registered Nurse C on 8/6/2020 at 12:00 PM who when asked about documentation of assessment, progress note, neuro checks and vitals and intravenous rate and amount infused of Dilantin IV stated "I didn't do them. My documentation was not good." When asked if Registered Nurse C had conversation with Unit Manager H in regards to the occurrence Registered Nurse C stated "You mean like a 1 on 1 conversation about it? There wasn't one." When asked about the floor's expectations for vital signs post fall or adverse occurrence Registered Nurse C stated "I think it is every 15 minutes x's 4 then every 30 minutes x's four then hourly x's four."

An interview was conducted with Quality and Safety Team Improvement L and Director of Patient Relations K on 8/6/2020 at 1:30 PM when asked about missing documentation of nursing assessment, vital signs, neuro checks and IV infusion rate and amount infused Director of Patient Relations K stated "Yes there is a gap of what was documented in the record and care provided. I would expect that those things would be charted on." When asked the expectation of vitals and neuro checks on the unit after a fall or adverse occurrence Quality and Safety Team Improvement L stated "I can't find on a policy how often vitals should be done after an occurrence."