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.

UNIVERSITY OF WASHINGTON MEDICAL CTR 1959 NE PACIFIC ST BOX 356151 SEATTLE, WA 98195 Oct. 13, 2016
VIOLATION: INFECTION CONTROL Tag No: A0747
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Based on observation, interview and review of the hospital's infection control program, the hospital failed to develop and implement an effective infection prevention and control program.
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Failure to systematically perform surveillance, prevent the spread of infections, and control infections risks transmission of infections between patients.
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Findings:
.1. The hospital failed to monitor and implement an effective infection prevention program that included the following:
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a. Storage of clean hospital linen in designated construction zones.
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b. Posting of important alert messages to patients, visitors, and staff concerning interim water restriction measures.
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c. Routine cleaning and sanitizing of patient care area ice machines.
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Due to the scope and severity of deficiencies cited under 42 CFR 482.42, the Condition of Participation for Infection Control was NOT MET.
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Cross Reference: A0749
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VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
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Item #1 - Transmission Based Precautions

Based on observation and review of hospital policy and procedure, the hospital failed to ensure that staff members properly donned personal protective equipment (PPE) when working with patients that require expanded transmission based precautions.

Failure to properly don personal protective equipment places patients and staff at risk of infection.

Reference: Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, pg 135: " Donning PPE: Gown: Fully cover torso from neck to knees, arms to end of wrist, and wrap around the back. Fasten in back at neck and waste. "

Findings:

1. The hospital policy titled "Standard and Expanded Precautions Programs" (Rev. 10/2/2015) states in part, "Contact Enteric Precautions: Healthcare workers are required to wear gloves and gowns when entering the room ..." and "Guidelines: Most recent CDC Precautions for Acute Care Hospitals: 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings."

2. On 9/23/2016 at 11:30 AM, Surveyor #3 observed a hospital assistant (Staff Member #8) on the 5th floor of the Cascade Tower enter a room posted for contact enteric precautions with his/her gown untied at the back.

Item #2 - Clean Linen Storage

Based on observation, the hospital failed to ensure that clean linens were stored in an environment free from potential contaminants.

Failure to properly store clean linens places patients at risk of exposure to infectious or toxic substances.

Reference: CDC and the Healthcare Infection Control Practices Advisory Committee, " Guidelines for Environmental Infection Control in Health-Care Facilities " ; 2003, pgs. 139, 212

Findings:

On 9/26/2016 at 11:30 AM, Surveyor #1 and #3 toured a construction zone on the 4th floor of the Cascade Tower. During the tour, the surveyors observed 4 carts of clean linens stored in the construction zone, which did not have the recommended pressure relationships for clean linen storage and presented the potential for dust generated as result of the construction. The manager of program operations (Staff Member #3) confirmed the observation.

Item #3 -Interim Legionella Infection Prevention Plan

Based on observation and interview, hospital staff members failed to adequately label all sinks in the Cascade Tower to protect patients, staff, and visitors from potential infections during the implementation of the Legionella infection prevention plan.

Failure to provide notice about restricted water use of hospital sinks due to possible bacterial contamination puts patients, staff, and visitors at risk of illness.

Findings:

1. On 9/23/2016, Surveyor #1 and Surveyor #2 continued a tour of the Cascade Tower. Between 11:00 AM and 11:30 AM, the surveyors observed that sinks in rooms 4111 and 5211 did not have filters in place or signage to indicate that water restrictions were in effect.

2. On 9/22/2016, Surveyor #1 and #3 toured the Cascade Tower to observe the facility's remediation efforts. At 11:45 AM, the surveyors inspected the emergency department and observed a sink in the bathroom without a filter or adequate signage identifying that water restrictions were in place.


3. On 9/22/2016 at 11:30 AM, Surveyor #1 and Surveyor #2 interviewed the Facilities Director (Staff Member #9) regarding the facility's Legionella remediation efforts. S/he indicated that filters were to be installed on all sinks in patient care areas, and, if filters were not available or could not properly fit on the faucets, signage would be placed at the sink indicating that water was only safe for use in hand washing procedures. S/he also confirmed the above findings at the time of observation.

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Item #4 - Cleaning of Ice Machines

Based on manufacturer's instructions for use, the hospital failed to maintain ice machines in a sanitary condition.

Failure to perform routine cleaning promotes the growth of microorganisms, which risks patient and staff safety.



Findings:

1. The Follett Ice machine 400 Series and Follett Symphony Plus 25 and 50 Series Ice and Water Dispensers Installation, Operation, and Service Manual under the section titled "Cleaning/descaling and sanitizing" read in part: " Periodic cleaning/descaling and sanitizing of Follett's ice and water dispenser and ice machine system is required to ensure peak performance and delivery of clean, sanitary ice. The recommended cleaning procedures that follow should be performed at least as frequently as recommended and more often if the environmental conditions dictate." The following cleaning frequency for both models listed on pages 14 and 17 state: "the frequency in cleaning and sanitizing ice machine according to the schedule below:"

Drain Line - weekly
Drain Pan/Drip Pan -weekly

2. On 9/26/2016 between the hours of 10:00 AM and 11:45 AM Surveyor #1 observed soiled buildup on the drip pan and drain line of the ice machine located in the Pacific Tower on the unit 5E.

3. The regulatory compliance manager (Staff Member #7) confirmed on 9/26/2016 that the hospital did not have polices or procedures regarding the routine cleaning of the ice machines.
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VIOLATION: GOVERNING BODY Tag No: A0043
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Based on observations, interviews, and document reviews, the hospital failed to meet the requirements at 42 CFR 482.12 Conditon of Participation for Governing Body.

Failure to meet physical environment, infection control, and quality program requirements risks an unsafe healthcare environment for patients, visitors, and staff.

Findings:

Due to the scope and severity of condition-level deficiencies detailed under 42 CFR 482.41 Condition of Participation for Physical Environment; 42 CFR 482.42 Condition for Participation for Infection Control; and 42 CFR 482.21 Condtion of Participation for Quality Assessment and Performance Improvment, the Condition of Participation for Governing Body was NOT MET.

Cross-Reference: Tags A0263; A0700; A0747
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VIOLATION: QAPI Tag No: A0263
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Based on observation, interview, and review of the hospital's Coordinated Quality Improvement Plan (CQIP), the hospital failed to develop and implement a quality program that provided effective oversight of the hospital's environmental and biomedical services.

Failure to provide such oversight resulted in lapses in preventive maintenance of ice machines and patient care equipment and subsequent bacterial contamination.

Findings:

1. The hospital's Quality and Safety Plan for fiscal year 2016 read in part: "Quality Improvement at UW Medical Center. Infrastructure: The quality and safety leadership model, under the direction of the Medical Director's Office, recognizes an interdepartmental matrix structure .... The work of quality and safety occurs through, but is not limited to specialized committee structures such as those listed below:

...Environment of Care Committee ... The Environment of Care Committee (EOCC) provides oversight for hospital wide initiatives involving the planning, implementation, and review of policies, systems, and procedures to maintain a hazard free environment for the patients, visitors, providers, and staff at UWMC."

2. During the survey, surveyors determined the following:

a. The hospital did not ensure that ice machines were installed and maintained in a sanitary condition according to the manufacturer's instructions for use.

Cross Reference: A0724, Item #1; A0724, Item #3; A0747

b. The hospital did not develop and implement an alternate equipment maintenance program based on accepted industry standards for maintenance of patient care equipment and FDA safety alerts.

Cross Reference: A0724, Item #2; A0724, Item #4

The cumulative effect of these deficiencies resulted in an unsafe patient care environment and is evidence that the Condition for Participation for Quality Assessment and Performance Improvement is NOT MET.
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VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
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Based on observations, document review, and interviews, the hospital failed to maintain the overall hospital environment in a way that protected the safety and well-being of patients.
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Failure to maintain a safe environment risks patient safety and protection from harm.
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Findings:
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1. The hospital failed to develop and implement an effective physical environment program that included the following:
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a. Appropriate cross connection controls to protect equipment from potential contamination.
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b. Dissemination of important safety communication messages affecting bio-medical equipment to clinical departments and leaders.
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c. Preventative maintenance and cleaning of facility ice machines.
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d. Routine preventive maintenance of bio-medical equipment.
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Due to the scope and severity of deficiencies cited under 42 CFR 482.41, the Condition of Participation for Physical Environment was NOT MET.
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Cross Reference: Tags A0724; A0749
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VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
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Item #1 Cross-Connection Controls

Based on observation, the hospital failed to provide appropriate cross-connection controls to protect equipment from potential contamination.

Failure to provide an adequate slope angle in drainage-line systems allows water to stagnate in the line which can promote the growth of microorganisms placing patients and staff at risk of developing infections.


Findings:

1. The Follett Series/W, MCD400A/W, R400A/W, MFD400A/W, D400A/W Ice Machines -Installation, Operation and Service Manual (Serial numbers above D ) provided a diagram of incorrect installation (page 15).

The service manual identified elements of incorrect installation that read in part:

- Dips in tube where water can collect

- Splice or tight bend that restricts ice flow

- Uninsulated tube that results in wet ice and potential dispensing problems

2. The Follett Symphony Plus service manual noted the following on page 4: "Water shut-off recommended within 10 ft. (3 m) of dispenser. Drain to be hard-piped and insulated. Maintain at least 1/4" per foot (20 mm per 1 m) run of slope."

3. On 10/26/2016, between the hours of 10:00 and 11:45 AM, Surveyor #1 noted that the drain-line of the Follett Ice Machine located in the Pacific Tower on unit 5E was not sloped to grade to the floor drain as per manufacturer instructions for installation.





Item #2 Medical Equipment Alert Notification Process
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Based on document review, interview, and review of hospital policy and procedures, hospital staff members failed to notify affected clinical departments upon receipt of safety communication messages regarding medical equipment used in those departments.
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Failure to notify clinical areas when hospitals receive information on safety concerns regarding specific medical equipment puts patients and staff at risk of harm from dangerous or malfunctioning devices.
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Findings:
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1. The hospital policy titled "Recall and Hazard Alert Management Program" (Policy # 75-5; Reviewed 04/15/2016) under the section titled "Policy Purpose" read in part: "The purpose of the Recall and Hazard alert program is to ensure that recalls and hazard alerts are addressed in a timely manner. This process includes notifying responsible individuals within user departments (Departmental Recall Coordinators), and ensuring that required actions are performed, documented and report back to University of Washington Medical (UWMC) Recall Coordinators, (Materials Management/Supply Chain [MM] or Clinical Engineering [CE]."
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The policy under the section titled "Procedures" read in part: "2. UWMC utilized the "Alerts Tracker" system provided by ECRI [Emergency Care Research Institute] to notify and track equipment, product, or supply related recalls and hazard alerts. 3. Alert notifications are distributed by ECRI on Friday of each week to all participants in the program in form of summary Emails. Assignments are made to the department recall coordinators, (Assignees), by a UWMC Recall Coordinator within 3 working days. Assignees are responsible for investigating, taking actions as needed, documenting actions and notifying Clinical Engineering (CE), Materials Management/Supply Chain (MM) or the Medical Equipment Management Sub Committee as appropriate. . . 5. The departmental recall coordinators have five working days to review the alert, investigate, and update the status in Alert Tracker to "Not Applicable", "Applicable Open" or "Applicable Closed". Any alerts found to be applicable not closed will be resolved and the status will be updated as soon as possible. 6. All department and central responses are documented in Alerts Tracker."
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2. On 10/16/2015, the Food and Drug Administration (FDA) issued a Medical Device Safety Communication alert titled "Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated with Nontuberculous Mycobacteria Infections". The section titled "Action Needed" contained nine recommendations including in part: "FDA recommends the following: "Do not use tap water to rinse, fill, or top-off water tanks since this may introduce NTM [Nontuberculous Mycobateria] organism. Use only sterile water or water that has been passed through a filter of 0.22 microns. When making ice needed for patient cooling during surgical procedures use only sterile water or water that has been passed through a filter of 0.22 microns."
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3. On 9/27/2016 at 11:35 AM, Surveyor #5 interviewed the Manager of Clinical Engineering (Staff Member #1) about the hospital's Alerts Tracker system. Surveyor #5 asked Staff Member #1 to demonstrate how the medical alert tracker system operated and asked him/her to display the FDA medical device hazard report #H0284 issued for heater-cooler devices on October 16, 2015.
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A review of the alert tracker system indicated that a bio-medical technician (Staff Member #2) viewed the message on 10/26/2015 and listed the status as "Applicable -Open". The alert was not forwarded to applicable clinical leaders until 5/25/2016. A review of the section labeled alert 'current status details' listed the action taken as "None" . The manager of clinical engineering (Staff Member #1) confirmed the finding that staff did not take action and did not forward the message to either staff in the operating room or in the perfusion areas as required by policy.
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4. On 9/27/2016 at 1:00 PM, Surveyor #5 reviewed a document that listed the time-line of actions the facility implemented during their internal legionella outbreak investigation to determine when the hospital began to follow recommendations outlined in the FDA Safety Communication. The surveyor noted the facility began using sterile water instead of tap water for the water tank of the heater-cooler units on 9/12/2016. In addition, Surveyor #5 noted the facility did not install micro filtration (0.2 microns) on the new ice machines supporting the operating rooms until 9/16/2016 as recommended by the FDA communication.
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Item #3 - Ice Machine Preventative Maintenance

Based on record review, review of hospital policy and procedure, and interview, the hospital failed to ensure that ice machines were properly maintained.

Failure to properly maintain equipment risks patient and staff safety.

Findings:

1. On 9/23/2016 at 9:15 AM, Surveyors #1 and #3 interviewed a refrigeration technician (Staff Member #4) about the preventative maintenance and cleaning procedures for the facility ice machines. S/he indicated that preventative maintenance is conducted semiannually. The surveyor found no documentation to indicate the hospital had a policy for maintenance of ice machines.

2. On 09/23/2016 at 2:30 PM, Surveyors #1 and #3 reviewed preventative maintenance records for the facility's ice machines. An ice machine that had been in use in the perioperative area until 9/14/2016 had no record of semiannual preventative maintenance being performed as required. An environmental sampling taken on 9/8/2016 revealed the ice machine was heavily contaminated with 15,760 colony forming units of legionella species. The last documented preventative maintenance was completed on 1/2015. The Manager of Program Operations (Staff Member #3) confirmed this finding.

Item #4 - Bio-Medical Device Preventative Maintenance

Based on record review, review of hospital policy and procedure, electronic communication, and interview, hospital staff members failed to properly maintain medical equipment.

Failure to properly maintain medical equipment risks patient and staff safety.

Findings:

1. The hospital policy and procedure titled "Medical Equipment Management" (Rev. 5/24/2016) states in part, "Criteria and Inventory: Concurrent with the initial inspection, the equipment is evaluated for inclusion in the medical equipment management program based on function, risk, area of use, maintenance requirements and failure data including incident history."

Under the section titled "Inspection, Testing, and Maintenance", it read in part: "Devices included in the medical equipment management program, including equipment on service contract and departmentally maintained equipment, are scheduled for routine inspection at routine intervals. Individual work orders are generated at the assigned minimum inspection intervals which are based on manufacturer recommendation, level of risk, and medical center experience. For items where we have limited historical data, the assigned minimum interval defaults to the manufacturer's recommendation. Periodic Review of maintenance history allows us to identify and implement appropriate adjustments to the default schedule."

"The risk based maximum inspection intervals are determined by the four equipment types and are how we determine when an item is reported as overdue for inspection."

"Establishing Inspection Intervals: When it has been established that a new piece of medical equipment will be included in the program, the Clinical Engineering (CE) technician performing the initial inspection will match the inspection schedule to existing equipment. If there is no existing equipment to match schedules with, the technician will refer it to the CE shop supervisor who will establish an inspection interval based on the manufacturer's recommendations, assessed risk, or a default value of 12 months. The shop supervisor reviews all schedules before they are entered into the system."

2. On 9/26/2016, Surveyors #1 and #3 received and reviewed documentation regarding the maintenance history of 20 pieces of selected equipment. The surveyors noted that 12 of the 20 pieces of equipment ( heater/cooler units -Cardioquiup MCH-1000) had their most recent preventative maintenance performed after the specified minimum due date. All 12 of the heater coolers had preventative maintenance due dates of 7/29/2016 and the most recent maintenance record indicated that an open work order was entered into the records on 9/26/2016.
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One heater/cooler unit (Asset #: F0111) had an installation date of 2/28/2014, while the other 11 heater/cooler units had an installation date of 7/29/2015. This unit had a specified minimum preventative maintenance interval of 12 months and a maximum interval of 16.92 months according to the history report. Staff members performed the first preventative maintenance on 7/29/2016, which was beyond the maximum listed interval period described in the history report.

3. On 9/27/2016 at 11:30 AM, Surveyor #3 and #4 interviewed the Clinical Engineering Manager (Staff Member #1) about the medical equipment maintenance program and equipment history reports. S/he stated that the section of the form listed as "Base PMC" is the preventative maintenance due date. The section listed "MAX PMC" is the overdue date when equipment no longer can be used for patient care.
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Surveyor #3 asked him/her about the process of contracted maintenance since vendors maintained the heater/cooler units. S/he stated that work orders are generated approximately 30 days in advance of the scheduled vendor service. S/he provided documentation to indicate the hospital generated a work order for the heater/cooler units on 7/7/2016, but there was no evidence to indicate there was service scheduled with the vendor.

4. On 9/29/2016 at 9:54 AM, Surveyor #3 received a hospital document titled "UWMC Failure Review 2014-2015" via electronic communication (e-mail) from the Assistant Administrator (Staff Member #5). A description of an equipment failure for one of the heater/cooler units with a work order completion date of 4/02/2014 stated, "Touch screen does not work on heater/cooler. Found small damage on touchscreen, but system worked normally. Returned to service." The date of the failure indicates that the heater/cooler unit (asset #: F0111) experienced the mechanical problem. Despite having new equipment with a history of maintenance issues within the first year of service, the hospital elected to employ a maximum inspection interval that exceeded the manufacturer's recommended time frame for preventive maintenance.

5. On 10/06/2016 at 2:01 PM, Surveyor #3 received an electronic communication (e-mail) from the Director of Clinical Engineering (Staff Member #6) detailing the medical equipment maintenance program. S/he indicated that the risk assessment used to develop the maximum inspection interval was developed at least 20 years ago and could not find the original document. S/he stated, "At this point I must tell you that I'm no longer able to locate any documentation of the process that I followed over 20 years ago."

6. On 10/11/2016 at 8:45 AM, Surveyor #3 and #5 reviewed additional equipment history reports for various types of equipment to assess compliance with the hospital-developed alternative maintenance program. An Insight Vision Console (Intuitive Surgical Da Vinci SI), which had a preventative maintenance interval of 6 months, did not have record of preventative maintenance being performed between 12/23/2014 and 12/7/2015, a period of 12 months. The hospital's allowable maximum time frame for this device was 9.66 months.

7. On 10/11/2016 at 8:45 AM, Surveyor #3 reviewed maintenance history records for imaging devices and medical lasers. These types of equipment had documented preventative maintenance records within manufacturer's recommendations, but the documented service history forms kept by the facility indicate they are allowed maintenance windows with a maximum inspection interval beyond manufacturer's recommendations. Imaging and radiological equipment and medical lasers are to be excluded from any maintenance program that might deviate from manufacturer's specification.

8. On 10/11/2016 at 10:25 AM, Surveyors #3 and #5 interviewed the Director of Clinical Engineering (Staff Member #6) regarding the medical equipment management program. S/he stated that the initial risk assessment that allowed equipment to be placed under an alternative equipment maintenance program with a maximum inspection interval greater than manufacturer's recommendations was developed over 20 years ago based on experience, an understanding of the field, and collected failure data. The program and risk assessment have largely stayed the same. It has not been updated since initial development with current standards of practice or recommended guidelines to update the program.
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S/he also stated that the management program for radiological and imaging equipment and medical lasers is in the process of being reevaluated. New items do not receive a maximum inspection interval but older items have been "grandfathered" into the current alternative equipment management program.
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