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Based on interview, document review, and review of hospital policies and procedures, the hospital failed to ensure that electronic quality variance reports (eQVRs) were reviewed, investigated, and completed for 7 of 10 eQVRs reviewed (Item #1) and the hospital failed to review, analyze, and develop an action plan for a serious patient safety event within policy timelines (Item #2).

Failure to review, investigate, and complete eQVRs can result in a delay in implementing measures to prevent/mitigate future deviations in care that negatively impact care and failure to review, analyze, and develop an action plan for a serious patient safety event within required timelines can lead to delay in implementing corrective actions (Item #2).

Findings included:

Item #1 - Quality Variance Reporting

1. Document review of the hospital's policy titled, "Electronic Quality Variance Reporting (eQVR) System," approved 10/15, showed that all staff and managers should follow the eQVR workflow and timeline as defined. The policy showed that timely reporting and investigation leads to timely implementation of measures to prevent/mitigate future events. After the patient is cared for, following an event, the staff person caring for that patient will complete an eQVR. Their manager has 72 hours to open the file, review and place initial harm level (Quality & Patient Safety makes the final determination of harm level due to impact on root cause analysis requirements) and within 2 weeks, perform an investigation with feedback. The policy stated that after the manager receives feedback then he or she has 1 week to sign off (sign off only MVR, ADR or SSE events) or close the file. This process allows managers 3 weeks from opening the file to either sign off or close the file.

Document review of the hospital's Quality Management System Plan, approved 07/10/18,showed that QVRs are online forms through which any caregiver or provider can report deviations from established processes or expected outcomes that negatively impact or have the potential to negatively impact the care and safety of patients or employees. These electronic forms are routed to leaders of the affected departments(s) plus the Quality Division, Medication Safety, Medical Staff Services, Risk Management, campus leadership for further review when appropriate, up to and including a Root Cause Analysis.

Core leaders are educated about the QVR process through classes and/or online training. When performing follow-up on a QVR, leaders define relevant aspects: what happened, why it happened, and actions taken to prevent immediate recurrence and long-time recurrence.

2. On 01/09/20 at 10:25 AM, Investigator #3 reviewed an eQVR that was initiated on 05/05/19 for a serious safety event that occurred on 05/04/19 resulting in a patient death. As a result, the event was assigned to the Patient Safety Office for an event analysis. The clinical supervisor (Staff #301) however, did not sign off or close the file until 06/05/19, which is 10 days beyond the hospital policy timeline.

3. On 01/10/20 at 8:10 AM, Investigator #10 and the Oncology Manager-12E (Staff Member #1001) reviewed six (6) eQVRs during October & November 2019.

One eQVR showed an event date of 11/28/19, however, the file did not contain an open date or a date that file was closed, the case was not completed.

A second eQVR showed an event date of 10/21/19 that involved a patient (Patient #1001) who experienced a chemotherapy splash to both his hands, after his intravenous (IV) administration tubing became disconnected. The report showed that during his IV chemotherapy, while he was in the shower the IV tubing became disconnected and the hazardous medication began to spill, spilling on both his hands and onto the bathroom floor. A Code Orange was called and environmental personnel preformed the hazardous clean up. The QVR file did not contain an open date, investigative notes or sign-off/closed date.

A concurrent interview with the Manager revealed that she addresses events in real time and occasionally may not remember to compete the eQVR. The review showed that 3 of 6 eQVRs were not completed according to policy timeline.

a. On 01/10/20 at 8:30 AM, Investigator #10 and the Oncology Manager-12SW (Staff Member #1002) reviewed three (3) eQVRs filed by her staff on 12 SW unit.

The first eQVR reviewed showed that the event was reported on 11/26/19 which detailed intravenous insertion issues on that day. Further review of the file showed that the manager opened and closed the file on 01/09/20, 44 days after the event occurred. The file did not include the manager's investigative notes or staff interviews.

The second eQVR reviewed showed an event that occurred on 10/16/19, and the manager closed the file on 12/16/19, 61 days after the event was reported. Further review of the file showed that the manager did not enter notes or interviews into the report.

A review of a third eQVR showed an event that was reported on 10/10/19, which involved a patient (Patient #1002) who found her clothing and bedding soaked with her chemotherapy solution when her IV administration tubing became disconnected, but she did not experience physical contact with the hazardous solution. The manager opened and closed the eQVR on 12/16/19, 67 days after the event was reported, without the manager's investigation notes or interviews.

4. On 01/08/20 at 2:50 PM, Investigator #10 interviewed the Director of Risk & Patient Safety (Staff #1003) about six reviewed eQVRs. Staff #1003 confirmed that the files were incomplete and that there was a lag in timelines.

Item #2 - Serious Safety Event

1. Document review of the hospital's policy and procedure titled, "Adverse Events: Investigation, Analysis, Internal and External Reporting, no policy number, approved 07/18, showed that case analysis should be initiated as soon as a harmful or potentially harmful event is identified. When an actual or potential adverse event is reported, the appropriate members of the event response team (medication safety, patient safety and risk management) conduct a preliminary review of the event to determine if it meets criteria for a root cause analysis (RCA).

If the event does meet criteria for a root cause analysis, a case analysis coordinator will be assigned. The coordinator will conduct interviews and perform an investigation to determine the timeline and facts of the case. Causal factors of the case will be determined and an action plan developed with key operational and subject-matter experts.

The timeframe from initiation of the RCA to review and approval by the Swedish System Operational Committee and the Swedish Health Systems board is intended to be no more than 45 calendar days.

2. Document review of the electronic quality variance report (eQVR) showed that a serious safety event occurred on 05/05/19 resulting in the death of a patient. An eQVR was initiated on 05/06/19 by the nurse manager (Staff #302). A patient safety officer (Staff #303) was assigned to investigate the event on 05/06/19. The serious safety event (SSE) was confirmed by the Clinical Case Review Committee (CCRC) on 11/18/19 with approval of the action plan on 12/02/19.

3. Document review of the RCA report showed that the incident occurred on 05/04/19 with the causal analysis and developed action plan approved and confirmed on 12/02/19. The report showed the event was classified as preventable and was classified as a SSE level one incident. A SSE-1 event is a deviation from generally accepted practice standards that reaches the patient and results in death.

4. On 01/09/20 at 12:55 PM, Investigator #3 interviewed the Patient Safety Officer (PSO) (Staff #303) who investigated the SSE and the Manager of the Patient Safety Office (Staff #304).

Staff #303 stated that she completed her investigation and developed a preliminary action plan before the end of May 2019. She then sent multiple written communications to the Chief Nursing Officer (Staff #305) (who was the executive sponsor) requesting to debrief the event to hospital's key leaders as early as 06/10/19. Staff #303 also stated that she had several in-person conversations with the CNO about scheduling the RCA debrief and was told that her schedule was very busy and that her administrative assistant would get back to her to arrange a time and date.

The PSO Manager (Staff #304) stated that this RCA should not have taken so long to get scheduled. She stated that scheduling can be a challenge and coordinating a date and time is complex with the hospital's leadership given their span of responsibilities. Since this event occurred, time is now blocked for debriefing RCAs.

5. On 01/10/20 at 8:20 AM, Investigator #3 interviewed the Chief Medical Officer (CMO) (Staff #306), the Chief Nursing Officer (CNO) (Staff #305), and the Chief Operating Officer (COO) (Staff #307) about the SSE which occurred on May 4, 2019. The investigator asked why it took over 5 months to debrief the findings to the hospital's senior leadership. The CNO stated that it is difficult at times to coordinate all the key stakeholders' schedules. The CMO stated that the hospital leadership recognized with this case that their current review process creates an unnecessary lag in having the event debrief and an initial action plan reviewed. As a result, the hospital leadership now designates 2 days each month for review of SSEs. The COO confirmed that any item approved in the action plan would be implemented and funding obtained if needed.

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Based on observation and interview, the hospital failed to maintain patient care supplies in a manner that prevented storage and use beyond the manufacturer's designated expiration date.

Failure to ensure patient care supplies are not expired risks ineffective patient care and treatment, and potential for patient harm.

Findings included:

1. On 01/07/20 at 11:10 AM, Investigator #6 and the Director of Environment of Care, Emergency Management, and Security (Staff #601) inspected the Emergency Department (ED) hallway opposite Imaging. The observation showed the following expired patient care supplies available for use:

a. 1000 mL Intravenous Solution bag, expired 12/19;

b. 5 of 5 Xeroform Occlusive Gauze Patches, expired 12/19;

c. 5 of 5 3M Sterile Drapes, expired 11/21/19.

2. Staff #601 removed the expired supplies at the time of the observation. Investigator #6 asked an ED Tech (Staff #602) about the hospital's expectation for management of patient care supplies. Staff #602 stated that ED Techs are assigned to manage patient care supplies each day and that the expired supplies should have been removed.

3. On 01/08/20 at 8:30 AM, Investigator #8 inspected the emergency carts and supplies in the Emergency Department's "Flex" room. The observation showed:

a. 18 expired vacutainers with expiration dates between 07/18 and 01/19.

b. 2 intravenous insertion catheters with expiration dates of 12/18 and 07/19.

c. 7 opened and undated packages of cardiac electrode patches that should have been in a closed container.

4. On 01/07/20 at 11:10 AM, Investigator #6 interviewed the Regional Director for Emergency Services (Staff #801) and the Emergency Room Manager (Staff #802) who confirmed the findings.

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Based on observation, document review, and interview, the hospital failed to maintain the environment in a sanitary condition free of accumulation of dust and debris.

Failure to maintain a sanitary environment places patients, staff, and visitors at increased risk of exposure to allergens and harmful microorganisms.

Findings included:

1. Document review of the hospital's policy titled, "Environmental Services Cleaning ED Exam Rooms," policy #900.34, approved 03/13, showed that Environmental Services (EVS) staff are to wipe sides and tops of furniture and equipment in ED and Exam rooms, and should dust mop and wet mop all floor surfaces.

Document review of the hospital's un-numbered, undated document titled, "First Hill Environmental Services ER Room ES Tech Daily Assignment," for 7:00 AM - 3:30 PM shift, showed that the daily tasks include all patient care areas of the Emergency Department including Quiet Rooms, Exam Rooms 1 - 10, East Rooms 11 - 22, and ER Triage 1 - 4.

2. On 01/07/20 between 9:50 AM and 12:30 PM, Investigator #6 toured the Emergency Department with the Director of Environment of Care, Emergency Management, and Security (Staff #601). The observation showed the following areas with accumulations of dust and debris, and unclean surfaces:

a. ED Hallway C & D - accumulated dust and debris in the frame and base, splatter stains and dried debris on the base and wheels of 2 of 2 gurneys available for patient care. Patient blood- draw chair had dried blood stains on the folding trays and frame. There was accumulated dirt, dust and stains on the floor;

b. ED Triage RMA 1 - dried debris on a patient chair, accumulated dust and debris on the floor;

c. ED Triage RMA 4 - dried debris on the support base of the computer on wheels, dried debris on a stainless steel Mayo tray and rolling stand, accumulated dust and debris on the floor;

d. ED Hallway opposite imaging - there was a 3-drawer rolling supply cabinet that held a drawer with patient supplies that contained dust accumulation.

e. ED Medication Room - accumulated dried debris around the handwashing sink, accumulated dust and debris on open shelves below the counter;

f. ED East Wing Bay 15 - dried debris on the frame of a gurney.

3. On 01/09/20 between 1:20 PM and 2:00 PM, Investigator #3 toured the 6th floor Surgical Intensive Care Unit (ICU) and the 8th floor Medical ICU with the Director of Environment of Care, Emergency Management, and Security (Staff #601). The observation showed that the floor below several wall-mounted hand sanitizer dispensers was sticky with residue and accumulated dust and debris.

4. On 01/09/20 at 2:20 PM, Investigator #6 interviewed an Environmental Services (EVS) Tech (Staff #606) about the cleaning schedule in the ED. Staff #606 stated that room cleaning is shared between ED Techs and EVS Techs. Staff #606 also stated that the ED is frequently too busy for thorough cleaning.

The investigator asked Staff #606 about cleaning floors throughout the hospital. Staff #606 stated that the floors are cleaned by a floor care team on a separate schedule.
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