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Based on observation, interview, and record review, the hospital failed to comply with the Conditions of Participation for Infection Control as evidenced by:

1. In the neonatal intensive care unit (NICU, an intensive care unit designed for premature and ill newborn babies), some surfaces and equipment were covered with dust (refer to A749);

2. In the NICU, staff for cleaning surfaces were unclearly designated (refer to A749);

3. In the NICU, environmental service staff (EVS) did not follow manufacturer's instructions for cleaning the Giraffe OmniBed (an incubator and radiant warmer bed) (refer to A749);

4. During a Methicillin-Resistant Staphylococcus Aureus (MRSA, a type of staph bacteria that has become resistant to many of the antibiotics used to treat ordinary staph infections) outbreak (the occurrence of cases of disease in excess of what would normally be expected) in the NICU, the hospital did not follow recommendations of the Santa Clara County Public Health Department or the California Department of Public Health's Healthcare-Associated Infections Program (HAI) (refer to A749); and

5. During a MRSA outbreak in the NICU, the hospital's infection control committee did not provide oversight (refer to A749).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, investigating, and controlling infections and/or communicable diseases, in accordance with the hospital's policies and procedures and recommendations from the Santa Clara County Public Health Department (PHD) and the California Department of Public Health (CDPH) Healthcare-Associated Infections (HAI) Program, during a Methicillin-Resistant Staphylococcus Aureus (MRSA, a type of staph bacteria that has become resistant to many of the antibiotics used to treat ordinary staph infections) outbreak (the occurrence of cases of disease in excess of what would normally be expected) in the neonatal intensive care unit (NICU, an intensive care unit designed for premature and ill newborn babies) when:

1. In the NICU, some surfaces and equipment were covered with dust;

2. In the NICU, staff for cleaning surfaces were unclearly designated;

3. In the NICU, environmental service staff (EVS) did not follow manufacturer's instructions for cleaning the Giraffe (an incubator and radiant warmer bed);

4. The hospital did not follow recommendations of the PHD and the CDPH HAI program; and,

5. The hospital's infection control committee did not provide oversight.

These failures increased the risk of spreading infection to medically compromised babies in the NICU.

Findings:

A review of "Antimicrobial Resistant Organisms, Infection Prevention - Acute Care Hospital Assessment, Summary of Findings & Recommendations", dated 12/18/19, indicated the PHD staff and the CDPH HAI program staff visited the hospital and provided the summary of the observations during the onsite infection prevention assessment, specifically targeting MRSA. It indicated the recommended interventions should be implemented regardless of whether any patient with resistant organisms were present.

The recommendations included, based on the one-day assessment:

(1) Staff and visitors did not use the plastic covers to place their cell phones in after cleaning.

(2) No timer available to ensure one-minute hand washing performed per the hospital's policy, at the sink, before entering to the NICU.

(3) Ensure all personnel including medical staff/students entering the unit perform one-minute hand washing per the hospital's policy. Continue to conduct routine hand hygiene (HH) adherence monitoring and provide feedback to the respective department leadership to facilitate HH compliance.

(4) An EVS staff were observed cleaning the Giraffe in a hallway. Recommend to identify appropriate room or area for effective cleaning of the equipment as well as storing the clean isolette. Consider reaching to the vendor to validate the cleaning process and the disinfectant product were appropriate per the manufacturer's recommendations.

(5) Perform routine adherence monitoring for compliance of cleaning patient care equipment.

(6) Ensure all staff including ancillary staff are knowledgeable about the contact time required for the disinfectant wipes.

It indicated as additional comments to ensure placement of colonized (when bacteria reside on an individual, but there are no signs or evidence of infection) patients away from the clean patients when they are transferred to ICN 1 / ICN 2 to prevent risk of exposure.

During an interview with the pediatric infectious disease physician (IDMD) on 1/22/2020 at 10:12 a.m., when asked if MRSA colonized babies were isolated she responded "no". The IDMD further stated colonized babies had not been isolated in the NICU ever, only if there would have been an open wound with MRSA or osteomyelitis (an infection of the bone). The IDMD stated the physician from CDPH HAI recommended isolating babies colonized with MRSA, but as of the day of the interview, no colonized baby had been isolated in the hospital.

During an interview with the NICU nurse manager (NMGR) on 1/22/2020 at 10:27 a.m., she stated the hospital was "working with two different manufacturers to figure out a date to come in and provide education on cleaning the Giraffes." The NMGR also indicated the hospital was "working on" education and signage regarding handwashing. When asked since two babies were identified as having the same strain of MRSA at peripheral intravenous insertion sites, whether nurses were observed for intravenous insertion techniques, the NMGR responded there was "no formal plan to do that." ... "That may be identified as a gap."

During an interview with the director of infection prevention and control (DIPC) on 1/22/2020 at 10:54 a.m., she stated the infection control committee meets monthly. When asked what the focus of the meeting is, she responded the "aim is to address current issues and outbreaks."

During an interview with the director of respiratory services (DRS) on 1/22/2020 at 10:58 a.m., she stated she was aware of the outbreak and her plan was to observe her respiratory therapists, but until the day of the interview, she did not observe her staff in the NICU for their infection control practices.

During an interview with the DIPC on 1/22/2020 at 11:10 a.m., when asked about the implementation of the PHD and CDPH HAI recommendations, received on 12/18/19, she responded "by no means have we completed our action items."

During an interview with the NICU director of patient care services (NDIR) on 1/22/2020 at 2:41 p.m., when asked about the frequency of hand washing audits, she responded "I do not believe there is one for each shift."

During a tour of the NICU 260 on 1/22/2020 at 1:30 p.m., there was no timer for one-minute hand washing, at the sink, before entering to the NICU. The NMGR confirmed that there was no timer to ensure staff or visitors washed their hands for a minute.

During an observation and concurrent interview, in the NICU 260 on 1/22/2020 at 1:40 p.m., two window frames, two printers, countertops, a vaccine refrigerator, and arms of ceiling monitor holders had grey and black particles. The NICU clinical nurse specialist (NCNS) wiped these areas and stated "dusty".

During a concurrent observation and interview, in the NICU 260, a negative pressure isolation room (an isolation technique used in hospitals prevent cross-contaminations from room to room. It includes a ventilation that generates negative pressure to allow air to flow into the isolation room but not escape from the room), Room A, was observed. In the anteroom (a small room before entering the isolation room), a work station on wheels (WOW) had several brown spills at the bottom of the frame and a full cup of soda and a food package were placed on the counter. Registered Nurse 4 (RN 4) confirmed she did not clean the WOW at the beginning of her shift and there should be no food stored in the anteroom.

During a concurrent observation and interview on 1/22/2020 at 2:13 p.m., there was a medication dispensing machine, near the isolation room, which was covered with grey particles. The director of Housekeeping (DHKP) stated EVS staff should have cleaned dust.

During a concurrent observation and interview, a scale for weighing babies had gray particulate at the base. NMGR stated EVS staff cleaned the dust at the base of the scale and DHKP stated nurses cleaned the scale including the base.

During an observation of NICU 270 on 1/22/2020 at 3:00 p.m., a computer keyboard in Patient Room B, bed space C had a dark red spot measuring approximately 1/2 cm (centimeter, a unit of measure) in diameter and clear (dried) splatter drops over the whole surface. When asked what the red spot was, registered nurse 3 (RN 3) stated she "just drew blood" from the patient. When asked about the clear splatter, she stated she "tried to take it off."

During an observation and interview of NICU 260 on 1/22/2020 at 3:15 p.m., environmental service staff 1 (EVS1) was cleaning a Giraffe in a hallway. EVS 1 stated she was cleaning it using clothes from a "purple top" container. The lid of the container, Super Sani-Cloth® Germicidal Disposable Wipe, was open. The DHKP stated she should have used Oxycide (a type of disinfectant cleaner), which was contained in a blue container and placed next to the purple top container. EVS 1 stated she was unaware the differences between the purple top container and Oxycide.

A review of the manufacturer's instructions, "Giraffe OmniBed", indicated Isopropyl Alcohol at a maximum concentration of 15% may be used to clean and disinfect the product.

A review of the product label for "Super Sani-Cloth® Germicidal Disposable Wipe" indicated the product contained "Isopropyl Alcohol 55%."

During an interview on 1/24/2020 at 10:20 a.m., EVS 2 stated he was aware of the PHD and the CDPH HAI program's recommendation not to clean the Giraffes in the hallway, but there was no room available, besides an isolation room, which was normally occupied, so the Giraffes would still be cleaned in the hallways.

During an interview with infection control specialist 2 (ICS2) on 1/24/2020 at 2:56 p.m., when asked if she did handwashing observations on a regular basis, she responded, "I have a couple of audits I have done. We rely on the secret shopper [a type of audit using a card/paper] and the unit to perform audits."

During a concurrent interview, ICS1 stated the hospital had an electronic system and anyone could enter their hand washing audits. The NMGR stated she planned to audit one staff per one shift but it was not done as planned. She stated around 20 of 180 staff were observed for their hand washing for 2 months and it was not enough observation.

During a concurrent interview, when asked who received/collected all data from either paper or the electronic system, regarding hand hygiene adherence, ICSs 1 and 2 stated the infection control team did but were unable to provide the evidence that the infection control team collected all data, analyzed whether the results were met the goal, and followed-up, indicating the NICU staff implemented their hand washing properly and the team conducted routine HH adherence monitoring as recommended.

During an interview on 1/24/20 at 3:30 p.m., the NMGR stated there was no evidence the audits for family or visitors' hand washing and using of plastic bags for their cell phones, were done as recommended.

During a concurrent interview and record review on 1/24/2020 at 3:45 p.m., the hospital's Infection Control Committee Minutes, dated 12/12/19, indicated "Unusual Organisms/Outbreaks/Clusters: NICU MRSA X6 [6 cases], reminder to perform good hand hygiene." There was no further information. ICS 1 confirmed that there was no evidence the committee discussed, developed action plans, implemented, evaluated, and oversaw the plans regarding the NICU MRSA outbreak.

During an interview with the director of housekeeping (DHKP) on 1/24/2020 at 3:48 p.m., he stated a space was identified "this week" for cleaning the Giraffes, instead of hallways, but was not ready yet ... we need to move some things around." He stated he was aware staff cleaned Giraffe in a hallway and it was a concern because of the closeness of clean and dirty areas. He stated he did not talk to his staff in the daily huddles regarding the Giraffe cleaning issues and he did not give them an in-service about cleaning per the PHD and CDPH HAI recommendations. He also stated he did not reach out to the vendor to validate the cleaning process and the disinfectant products were appropriate per the manufacturer's recommendations.

During an interview with the IDMD on 1/24/2020 at 3:58 p.m., when asked if colonized patients were away from clean patients during transport, she responded, "I don't know if we did that ... we never really isolated colonized patients that was one of the things they recommended."

A review of the hospital's Job Description, "Director-Infection Prevention & [and] Control", dated 4/27/2017 and revised 8/29/2018, indicated to provide strategic direction and oversight of all infection control programs for the hospital, develop the strategies necessary to achieve organizational goals related to infection and prevention control, direct the implementation of hospital-wide infection prevention program, collaborate with the health department related to outbreaks, exposures and the control of communicable disease, monitor isolation practices, make rounds on all units/departments to include evaluation of infection control and isolation practices, provide coaching and resources to staff, patients, and caregivers, monitor hospital environment and cleaning procedures, serve as a resource for environmental services to guide selection and use of cleaning products, and identify and introduce evidence-based infection prevention and control best practices.

A review of the hospital's policy, "Investigation of an Infectious Disease Outbreak and Contaminated Product Recalls", dated June 2019, indicated "An outbreak is defined as an increase over the expected occurrence of an event. A single case of an unusual disease or an organism can constitute an outbreak or cluster." ... "Implement infection control measures in accordance with CDC or local or State Department of Public Health recommendations."




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