HospitalInspections.org

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Based on observations, interviews, and document reviews, the hospital failed to meet the requirements at 42 CFR 482.12 Condition of Participation for Governing Body.

Failure to meet physical environment and infection control requirements risks an unsafe healthcare environment for patient 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 and 42 CFR 482.42 Condition of Participation for Infection Control, the Condition of Participation for Governing Body was NOT MET.

Cross Reference: Tags A0700; A0747

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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.

Failure to maintain a safe environment risks patient safety and protection from harm.

Findings:

1. The hospital failed to develop an implement an effective physical environment program that included the following:

a. Appropriate cross connection controls to protect equipment from potential contamination.

b. Medical alert and hazard notification process.

c. Preventative maintenance of facility ice machines.

Due to the scope and severity of deficiencies cited under 42 CFR 482.41, the Condition of Participation for Physical Environment was NOT MET.

Cross Reference: Tags A0724; A0726

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Item #1 - Ice Machine Installation

Based on observation, the facility 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 infection.

Findings:

1. The Hoshizaki DCM-270BAH(-OS) Instruction Manual states in part, "Drain lines must have ¼" fall per foot (2cm per 1m) on horizontal runs to get good flow ... "

The Little Giant VCM Condensate Pump manual states in part, "Piping 2. The discharge line (Figure 6) should be flexible tubing secured with a hose clamp (not provided) or pipe (3/8 inch I.D. maximum to prevent excessive flow back to unit). From the pump, extend the discharge line straight up as high as necessary (but not above the head/GPH of the pump). From this high point, slope the discharge line down slightly to a point above the drain, then turn down and extend to a point below or approximately level with the bottom of the pump. This will give a siphoning effect, which will improve the efficiency of the pump and will, in most cases, eliminate the need for a check valve ... "

2. On 11/30/2106 at 2:30 PM, Surveyor #2 inspected an ice machine in the dermatology surgery unit of the Roosevelt building. The Hoshizaki ice machine was installed with a Little Giant VCM model condensate pump. The discharge line for the pump was not sloped downward to the drain per manufacturer's instructions and had a dependent loop prior to entering the drain.


Item #2 - Ice Machine Preventative Maintenance

Based on observation, interview, and policy and procedure review, the hospital failed to ensure that ice machine preventative maintenance was performed per manufacturer's instructions.

Failure to properly maintain ice machines risks patient and staff safety.

Findings:

1. The hospital policy titled "Ice Machine Policy" (11/2/2106) states in part, "All ice machines will be cleaned and have maintenance performed in accordance with the manufacturer's recommendations."

2. On 11/30/2106 between 2:30 PM and 3:00 PM, Surveyor #2 toured the Roosevelt building. A Hoshizaki ice machine had a sticker that said "No scheduled service." The surveyor asked the Facilities Director (Staff Member #7) for preventative maintenance records of the ice machines in the Roosevelt building.

3. On 12/1/2016 at 12:20 PM, The Facilities Director (Staff Member #7) stated that preventative maintenance on the ice machines in the Roosevelt building was last performed in January of 2016. The instruction manuals for Hoshizaki DCM-270BAH(-OS) machines and other Hoshizaki machines indicate that a 6 month preventative maintenance is to be performed.
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Item #3 Medical Recall, Alert, and Hazard Notification Process
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Based on document review, interview, and review of hospital policy and procedure, the hospital failed to follow its medical alert and hazard notification process for 1 of 8 notifications reviewed.
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Failure to follow the hospital medical alert and hazard notification process risks vital safety information not being communicated to hospital staff and its leaders.
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Findings:
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1. The hospital policy titled "Recall and Hazard Alert Management Program" (Policy # 75-5; Reviewed 11/14/2016) 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 and documented."
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Under the section titled "Procedure" read in part: "2. UWMC utilizes the "Alerts Tracker" system provided by ECRI to notify and track equipment, product, or supply related recalls and hazard alerts . . . 4. The Departmental Recall Coordinator's response will depend on the circumstances of the alert and whether the alert affects that department but will always include updating the alert on the ECRI "Alerts Tracker" web site. 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 but 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 11/29/2016 at 10:30 AM, Surveyor #2 and the Director of Clinical Engineering (Staff Member #8) reviewed 8 alerts issued in the ECRI tracker system during the month of November. One alert involving an updated message on intravenous infusion pump batteries was sent to a departmental recall coordinator (Staff Member #9) on 11/11/2016. Surveyor #2 observed the message had not been viewed (11 working days) nor status updated as required by policy.
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3. On 11/30/2016 at 9:53 AM, Surveyor #1 interviewed the Director of Clinical Engineering (Staff Member #8) about the ECRI tracker system and policy changes made since the last survey. Staff Member #8 indicated that staff who access the ECRI tracker alert system were to receive additional training by November 18, 2016. A review of the training log (last updated on 11/28/2016) revealed that only 23 of 90 staff individuals had completed the required training.
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4. On 11/30/2016 at 12:00 PM, Surveyor #1 attended the hospital environment of care committee meeting. The Director of Clinical Engineering (Staff Member #8) provided an update on product recalls and hazard alerts for the months of October and November 2016. Staff Member #8 stated there were 147 recalls/alert for that time period with 12 items directly applicable to the hospital with four of those being completed, 8 still in progress and 54 alerts/recalls overdue for response with no status yet recorded.
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Based on interview and document review, the hospital failed to ensure that rooms where ortho-Phthalaldehyde (OPA) was used had the required air exchanges per hour.

Failure to perform the required number of air exchanges per hour places staff at risk of exposure to potentially toxic vapors from OPA.

Findings:

1. The Material Safety Data Sheet for Cidex OPA (a disinfectant) states in part, "Handling: Technical measures/precautions: Use in well-ventilated area and use with appropriate exhaust ventilation, for example a minimum of 10 air exchanges per hour ..."

2. On 12/1/2016 at 9:35 AM, Surveyor #2 asked the Facilities Manager (Staff Member #5) for the Eastside Specialty Center for documentation that the endoscope reprocessing room was achieving at least 10 air changes per hour (ACH). A document titled "DOH Design Parameters" was provided specifying that the reprocessing room was designed to achieve 21 ACH, but no documentation was provided that showed that the ACH had been verified. A ventilation station was present in the room, but staff were not placing the CIDEX beneath it during reprocessing.
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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.

Failure to systematically perform surveillance, prevent the spread of infections, and control infections risks transmission of infections between patients.

Findings:

1. The hospital failed to monitor and implement an effective infection prevention program that included the endoscope reprocessing and hydrocollator cleaning which followed manufacturer's instructions for use.

Due to the scope and severity of deficiencies cited under 42 CFR 482.42, the Conditon of Participation for Infection Control was NOT MET.

Cross Reference: A0749

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Item #1 - Personal Protective Equipment

Based on observation, the facility failed to ensure that staff properly wore personal protective equipment (PPE) when reprocessing endoscopes.

Failure to properly wear PPE places patients and staff at risk of infection.

Reference: SGNA Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes (2016).

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:

On 11/30/2016 at 9:20 AM, Surveyor #2 observed the reprocessing procedure for flexible endoscopes in the Digestive Disease Center. The medical assistant (Staff Member #1) performing the reprocessing procedure did not unfold and tie the gown around his/her back, potentially leading to cross contamination when moving from the dirty side of the reprocessing room to the clean side.


Item #2 - Endoscope Reprocessing

Based on observation, interview, document review, and policy and procedure review, the hospital failed to ensure that endoscopes were reprocessed according to manufacturer's instructions for use.

Failure to follow manufacturer's instructions for use for reprocessing endoscopes places patients at risk of infection.

Findings:

1. The hospital policy titled "Manual High-Level Disinfection using Cidex OPA, an Ortho-phthalaldehyde" (Rev. 12/26/2013) states in part, "II. High-Level Disinfection Procedure: E. Test the solution concentration prior to each use and log results to verify the Minimum Effective Concentration (MEC). 1. Testing procedure: a. Completely submerge indicating pad of the test strip in the solution. Hold for 1 second and remove. Do not shake strip. B. Remove excess solution by standing the strip upright on a paper towel. Strip must be vertical to work properly. Read results at 90 seconds; if read past 90 seconds the results are invalid. Pad will be completely PURPLE to indicate effective solution. IF ANY BLUE remains on the pad apart from the top line, the solution is ineffective and must be discarded. (SEE instructions on testing log). d. Confirm and document on log sheet that OPA solution is within proper temperature range (>68 degrees Fahrenheit). If below proper temperature range, double soaking time listed below."

"H. Set the timer for 12 minutes and allow the device to soak for the required 12 minutes at 20 degrees Centigrade (>68 Degrees Fahrenheit)."

2. On 12/1/2016 at 9:25 AM, Surveyor #2 interviewed a medical assistant (Staff Member #2) regarding the reprocessing procedures for cystoscopes (Olympus CYF-VHR) and observed a walkthrough of the reprocessing procedure at the Eastside Specialty Center. S/he stated that scopes are high-level disinfected in an automated reprocessing machine (Steris System 1E) and that the system would perform an alcohol flush following disinfection. A review of the reprocessor instructions for use does not indicate that the machine will perform an alcohol flush following disinfection. The endoscope instructions for use indicate that the scope should be flushed with alcohol prior to storage.

3. The cystoscopes were stored in the processing trays for the Steris reprocessor rather than hung vertically per the manufacturer's instructions for use.

4. On 12/1/2016 at 9:35 AM, Surveyor #2 interviewed a medical assistant (Staff Member #3) regarding the reprocessing of a naso-pharyngo-laryngoscope (Pentax FNL-10RP3) at the Eastside Specialty Center. S/he stated that the endoscopes are high-level disinfected with Cidex OPA (a disinfectant) by soaking them for 12 minutes at 68 degrees Fahrenheit. The surveyor reviewed the Cidex OPA logs and found multiple missing logs for the temperature of the Cidex OPA, the test strip results, and the soak end time for 11/10/2016, 11/17/2016, and 12/1/2016.

5. Surveyor #2 observed a naso-pharyngo-laryngoscope being stored coiled with a plastic covering. The manufacturer's instructions for use state "4-2. Post Reprocessing. 5) The endoscope should be hung in a clean, dry, well-ventilated storage cabinet at room temperature. The insertion tube and light guide cable should be hung and kept as straight as possible during storage."

6. On 12/1/2016 at 11:20 AM, Surveyor #2 interviewed a medical assistant (Staff Member #4) in the main campus Otolaryngology Department regarding endoscope reprocessing. S/he stated that Cidex OPA is used for high-level disinfection and that scopes are soaked for 12 minutes at 68 degrees Fahrenheit. S/he stated that if the temperature does not reach 68 degrees Fahrenheit, then the soaking time is doubled. The Cidex OPA logs for manual reprocessing of laryngoscopes had documented entries below 68 degrees Fahrenheit.

A correspondence (CL-105831 rev A 05/11) from Advanced Sterilization Products (the manufacturer of Cidex OPA) regarding Cidex OPA temperatures dated 5/18/2011 states, "In some cases, however, a reprocessing area may not be sufficiently warm to ensure a basin of Cidex Solution is above the required temperature, and in this case the Cidex Solution should not be used until the temperature is sufficient. Customers must make certain that the solution is warmed to the appropriate temperature before the reprocessing begins, and should have reasonable confidence that the minimum temperature is maintained or exceeded throughout the soaking time." The instructions for use state, "Manual Processing: high Level disinfectant at a minimum of 20 degrees Celsius (68 degrees Fahrenheit)."


Item #3 - Hydrocollator Cleaning

Based on observation and interview, the hospital failed to ensure that Hydrocollator heating units were cleaned according to manufacturer's instructions.

Failure to properly clean hydrocollators per manufacturer's instructions places patients at risk for unsafe care and infection.

Findings:

On 12/1/2016 at 9:50 AM, Surveyor #2 asked the physical therapist (Staff Member #6) at the Eastside Specialty Clinic for cleaning records of the Hydrocollator heating units (a device to heat heating pads). S/he stated that the staff were not performing and documenting the required cleanings in accordance with the manufacturer's instructions. The manufacturer's instructions for use indicate that the unit should be cleaned every two weeks.


Item #4 - Single Use Products

Based on observation and interview, the hospital failed to ensure that single use ultrasound gel bottles were not refilled.

Failure to properly dispose of single use ultrasound bottles places patients at risk from infection should cross contamination of gel occur during the refilling process.

Reference: CDC Clinical Outreach and Communication Activity (COCA) Clinical Reminder: April 20, 2012, "Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection."

Findings:

On 12/1/2016 at 9:50 AM, Surveyor #1 and Surveyor #2 inspected the physical therapy (Staff Member #6) unit of the Eastside Specialty Clinic. During the inspection, the surveyors noticed a single use bottle of ultrasound gel. Surveyor #1 asked the physical therapist if the bottles were refilled from a larger container. S/he said yes and showed the surveyors the large container of ultrasound gel that is used to refill the smaller bottle.