HospitalInspections.org

Based on document review and observation, it was determined that the Hospital failed to establish and maintain an Infection Control Prevention Program, to ensure all patients were free from exposure to the Legionella (pneumonia) bacteria. The Hospital also failed to develop a Water Management Plan based on the industry's standard of practice. This potentially placed all patients on the fourteenth and fifteenth floors of the Prentice Building at risk for exposure to infection. As a result, the Condition of Participation, 42 CFR 482.42, Infection Control, was not met.

Findings include:

1. The Hospital failed to demonstrate measures to minimize the risk of Legionnaires' disease (pneumonia) and failed to ensure protocols were developed for environmental assessments in the Water Management Plan (A-749A).

2. The Hospital failed to ensure adherence to infection control practices (A-749B).

3. The Hospital failed to ensure adherence to the dress code (A-749C).

4. The Hospital failed to ensure maintenance of a sanitary environment (A-749D).

A. Based on document review and observation, it was determined that the Hospital failed to establish protocols for environmental assessments, in response to Legionella [bacteria that causes Legionnaires' disease] cases identified. This could potentially affect all patients on the fourteenth and fifteenth floors of the Prentice Building.

Findings include:

1. The list of patients who tested positive for legionella pneumophila (LP-a bacteria that can cause pneumonia) was reviewed on 5/1/18. The list included 17 patients with a positive result. However 4 of the patients (Pts. #1, #2, #3 and #4) were identified as potentially having acquired the bacteria in the hospital. The most recent case identified on 4/23/18, (PT. #4) occurred after mitigating plans were initiated and in place, after the first identified case on 5/17/17. The clinical records for Pts. #1, #2, #3 and #4 were reviewed on 5/1/18.

Pt. #1 was a 57 year old female admitted to the Hospital's 16th Floor Prentice (stem cell transplant unit) on 5/9/17, with a diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy- a disease affecting the nerves). The Clinical Nurse Practitioner's Discharge Summary dated 6/8/17, was reviewed and indicated, " ... was admitted for stem cell transplant ... Between days +1 and + 10, (Pt. #1) had intermittent ... fevers ... On day +9 (5/24/17), (Pt. #1) had hypoxia and a neutropenic fever causing her rate (heart rate) to stay consistently in the 160's ... A rapid response team was called and she was transferred to the MICU (Medical Intensive Care Unit) ... On day +11 (5/25/17), her urine legionella (test for a bacteria causing pneumonia) came back positive and her antibiotics were narrowed to azithromycin. (Pt. #1) returned to 16 Prentice ... (Pt. #1) was discharged home in stable condition on 5/31/17."

Pt. #2 was a 35 year old female admitted to the Hospital's 15th Floor Prentice on 10/25/17, with a diagnosis of multiple sclerosis. The Clinical Nurse Practitioner's History and Physical dated 10/25/17, was reviewed and indicated, " ... admitted for ... stem cell transplant ... no hx (history) of infections ... Respiratory: no sob or cough, no dyspnea with exertion ... Chest X-ray 9/9/17 ... There is no acute cardiopulmonary process ..." The Infectious Disease Notes dated 11/7/17, indicated, " ... Pt. reports starting on afternoon of 11/6, she (Pt. #2) began feeling feverish with chills and shortness of breath ... CXR [Chest X-ray] 11/6/17: There is a subtle nodular opacity [vague appearance] in the left upper lung ... Follow-up chest radiography is recommended ..." Specimen [bronchial alveolar lavage-squirt fluid in lung for exam] for Pt. #2 was obtained on 11/8/17. The result came back positive for Legionella. Pt. #2 and was transferred to the MICU on 11/9/17. Pt. #2 died on 11/12/17.

Pt #3 was a 67 year old female, admitted to the Hospital's 15th Floor Prentice unit (Hematology-Oncology Unit) on 1/31/18, with fatigue and weakness. Pt #3 has a medical history of acute myeloid sarcoma [cancer], cerebral vascular accident [stroke], and deep vein thrombosis [blood clot]. Pt #3 reported that Pt #3 had been on a recent road trip to Springfield, Illinois. Pt #3 was transferred to the Medical Intensive Care Unit on 1/31/18, due to respiratory failure. The clinical record indicated that on 1/31/18, the medical doctor ordered blood cultures, respiratory pathogen panel, and CAT scan [x-ray] of the chest. On 2/8/18, a culture for Legionella Pneumophila was ordered and the test results came back positive 2/13/18. Pt #3 was treated with the following antibiotics: Cefepime, started on 2/6/18, and Levaquin, started on 2/13/18. Pt #3 was discharged to home on 3/15/18.

Pt #4 was a 52 year old male with a past medical history of Kappa Myeloma [cancer], and Human Immunodeficiency Virus. Pt # 4 had a previous admission on 3/28/18 to 4/13/18, for an autologous stem cell transplant [patient's stem cells removed from own bone marrow]. On approximately 4/21/18, Pt #4 began to spike fevers after his 4/13/18 discharge. Pt #4 was seen in outpatient clinic on 4/23/18, for onset of fever, chills, and dry cough and was directly admitted on 4/23/18, to the Hospital's 16th Floor Prentice (Stem Cell Transplant Unit). The clinical record indicated that on 4/23/18, at approximately 2:52 PM, an infectious work up was ordered to rule out viral upper respiratory infection, pneumonia, and possible vascular catheter infection. The infectious work up included a respiratory pathogen panel, respiratory culture, urine Legionella antigen, urine pneumonia antigen, 2 sets of blood cultures, urinalysis and culture, fungal studies, CAT scan [x-ray] of the chest, and a bronchoscopy [tube in nose or mouth to look at airway] with transbronchial biopsy [procedure to collect pieces of lung tissue]. On 4/25/18, urine was positive for urinary antigen of Legionella pneumophilia serogroup 1. Pt #4 was started on the following antibiotics as of 4/23/18: Vancomycin, Azithromycin and Cefepime. During this hospitalization, Pt #4 was placed on contact isolation precautions while waiting for infection workup results. On 4/25/18, Pt #4 was placed on droplet isolation. On 4/28/18, a medical doctor's progress note indicated recommendations for treatment of Legionella and to continue with Azithromycin, followed by a Legionella culture. Pt #4 was provided with discharge education about his medications to take at home, and his follow up appointments.

2. An observational tour and assessment was conducted by the Illinois Department of Public (IDPH) Environmental Health staff on May 1, 2018. The Hospital replaced shower wands and installed point of use filters on all patient room fixtures on the fifteenth and sixteenth floor of Prentice. As of May 1, 2018, the Hospital's consultants had not performed any validation testing for the point of use filters. All samples collected for monitoring were collected prior to the filter. The Hospital's Water Management Plan [WMP] also failed to include the performance of validation sampling for point of use filters.

3. On May 1, 2018, the Hospital's "Water Management Plan" (dated 3/15/2018) was reviewed and required, " ...The procedures (control measures) for minimizing Legionella are outlined in the Control Measures section .....Mitigation Activities Room 1568 remained closed after positive culture was received. Faucet was removed. Water pipes were decontaminated. Faucet was replaced with new faucet. ... Filters to be installed on all faucets (hand hygiene sinks and bathroom faucets) in addition to the shower heads ...The mitigation activities and timelines are included in the Water Treatment Action Plan ...." The Hospital's "Water Management Plan" lacked protocols as part of the WMP and did not detail actions for responding to cases of legionellosis [bacterial disease caused by Legionella].

4. The Hospital had no system in place regarding the flushing activities, to include flushing, frequency, fixtures, and patient protections. The Hospital's WMP did not have standard operating procedures for filter replacement and maintenance, including details on appropriate handling by environmental services staff to avoid retrograde [reverse] contamination and the disinfectants utilized.

5. The Hospital's WMP (dated 3/15/2018) did not provide information on criteria for removing patients from areas associated with cases of Legionella pneumonia or positive environmental samples; or establish verification procedures for flushing activities and adequate disinfectant residuals at all fixtures at all times as part of the "Water Management Plan."

6. The WMP did not detail procedures and frequency regarding water quality and monitoring or address all areas of possible transmission of Legionella, including identification of patients who are at high aspiration risk.


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B. Based on document review and interview, it was determined that for 1 of 4 (Pt. #1) clinical records reviewed with positive results for Legionella pneumophilia (bacteria that can cause pneumonia), the Hospital failed to ensure the isolation precaution order was followed, to prevent cross-contamination, as required.

Findings include:

1. On 5/1/18 at approximately 1:30 PM, the Hospital's policy titled, "Isolation Precautions" (effective 8/26/15) was reviewed and required, "...Policy Statement... B. (The Hospital's) employees... shall adhere to these guidelines regarding isolation precautions... Isolation Precautions: Measures taken... to prevent spread of potentially infectious agents... Responsibilities...6. Accurate documentation in the medical record will be made daily detailing the reason and category of isolation precautions for each patient on isolation precautions..."

2. On 5/1/18 at approximately 2:30 PM, the clinical record of Pt. #1 was reviewed. Pt. #1 was a 57 year old female admitted on 5/9/17 with a diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy). The clinical record indicated that Pt. #1 had a physician's order for droplet isolation from 5/22/17 at 9:41 AM until 5/23/17 at 2:52 PM. However, the clinical record did not indicate that Pt. #1 was placed in droplet isolation.

3. On 5/1/18 at approximately 2:30 PM and on 5/2/18 at approximately 1:30 PM, the findings were discussed with E #13 (Manager 15th Floor Prentice) and E #14 (Infection Preventionist). E #13 stated that the order for droplet isolation should have been followed. E #14 stated that the droplet isolation precaution was not documented in the medical record, to indicate that Pt. #1 was placed in droplet isolation.


C. Based on document review, observation, and interview, it was determined that for 2 of 2 Certified Registered Nurse Anesthetist/CRNA (E # 11 and E #12) and 1 of 1 Surgical Resident Physician (MD #1) in the inpatient OR (operating room), the Hospital failed to ensure that the surgical attire was followed, as required.

Findings include:

1. On 5/1/18 at approximately 3:00 PM, the Hospital's policy titled, "Surgical Scrub Attire" (effective 9/19/2016) was reviewed and required, "...III. Persons or Areas Affected: This policy applies to all regular and temporary, full-time and part-time employees... of (the Hospital)... C. Surgical Services Procedural Zones: 1. Restricted area: This includes the ORs (operating rooms)... Appendix A...VIII...A. Hair Cover: Head and facial hair shall be contained within protective coverings... F... Jewelry is not allowed in restricted areas..."

2. On 5/2/18 between 10:12 AM and 10:45 AM, an observational tour of the Hospital's inpatient surgical operating room was conducted. During the tour, in OR #18 where a sterile field was opened, E #11 and E #12 were observed with hair exposed on the side and back of the head, while MD #1 was observed wearing earrings.

3. On 5/2/18 at approximately 10:45 AM, findings were discussed with E #5 (Director of Surgery) and E #6 (OR Practice Manager). E #5 and E #6 stated that hair should not be exposed and earrings are not allowed in the OR.

D. Based on document review, observation and interview, it was determined that for 3 of 3 EVS/environmental services staff (E #8, E #9, and E #10) observed cleaning in the inpatient OR between cases, the Hospital failed to ensure that the room was cleaned as required.

Findings include:

1. On 5/2/18 at approximately 1:30 PM, the Hospital's guidelines titled, "(The Hospital) Surgical Areas Cleaning Guide" (revised 6/2017) was reviewed and required, "...Page 8... Between Case...Monitors (written in green)... OR lights (written in green)... EVS/environmental services... Equipment items or unidentified items not listed... in green is not cleaned by EVS... Three person team...8. Wipe down surfaces from top to bottom (lights, equipment...)..."

2. On 5/2/18 at approximately 11:00 AM, an observational tour of the inpatient surgical OR was conducted. During the tour, in OR #14, E#8, E #9, and E #10 were observed cleaning between patient cases. However, E #8, E #9, and #10 left the room without cleaning the OR light or the monitor screen.

3. On 5/2/18 at approximately 11:10 AM, interviews were conducted with E #5 (Director of Surgery), E #6 (OR Practice Manager), and E #7 (Resource Coordinator, Environmental Services). E #6 and E #7 confirmed that E #8, E #9, and E #10 had finished cleaning the room. E #7 stated that the OR lights, as well as the screen, should have been cleaned. E #5 and E #6 stated that they also did not see the EVS staff cleaning the OR light or the screen. E #7 stated that she (E #7) asked the EVS staff to go back to the room to clean the OR lights and the screen.