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 CALIFORNIA IRVINE MEDICAL CENTER 101 CITY DRIVE SOUTH ORANGE, CA 92868 June 19, 2019
VIOLATION: CONTRACTED SERVICES Tag No: A0083
Based on interview and record review, the governing body failed to ensure the EVS contracted service complied with all conditions of participation and standards of the contracted service. This failure had the potential for an unsafe environment to the patients, staff, and visitors.

Findings:

1. On 6/17/19 at 1220 hours, an observation of the between case cleaning in the L&D OR showed EVS 2 did not implement the hospital's P&P when cleaning the L&D OR. Cross reference to A749, example #1.

2. On 6/18/19 at 1300 hours, review of the personnel record for EVS 2 showed the last annual training was completed on 4/9/14 and review of the personnel record for EVS 5 showed the last annual training was completed on 4/9/15. Cross reference to A749, example #2.

On 6/17/19 at 0900 hours, a review of the contracted services was conducted with the Manager of Accreditation and Regulatory Affairs. The list of approved vendors identified Vendor A for EVS services and the last quality review date was 6/30/19.

During an interview with the CEO, COO, and Director 3 on 6/19/19 at 1200 hours, the Director stated the contract was changed to Vendor B on 3/31/18.

A concurrent review of the Governing Body meeting minutes was conducted. The minutes failed to show the Governing Body addressed the change from Vendor A to Vendor B.

A review of the contract for EVS services showed Vendor B was approved by the Governing Body but there was no documented evidence in the Governing Body or Quality and Safety Oversight Committee minutes to show the new EVS service was discussed with the Governing Body and there was no evidence of a Quality Review of this service on file.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on observation, interview, and record review, the hospital failed to ensure medications were secured and under supervision of the nursing staff. This failure had the potential for Patient 5 not to receive the medication ordered by the physician.

Findings:

Review of the hospital's P&P titled Medication Distribution, Storage, Security, and Handling dated 4/18 showed medications shall be stored in locked medication rooms. If a licensed staff is unable to administer a medication to the patient immediately, the medication must be secured, either by returning the medication to the locked medication room, locked cabinet/drawer, automated dispensing cabinet, or other secured storage area.

On 6/17/19 at 0830 hours, a tour of the NICU was initiated with Manager 1 and RN 1. A syringe containing a liquid was observed unattended resting on top of the computer work station in the hallway outside of Patient 5's room. No staff were observed in the area. RN 4 was observed returning to the work station from the other end of the unit. RN 4 stated the syringe contained Patient 5's medication. RN 4 further stated she was unable to administer Patient 5's medication because the occupational therapist was assessing the patient. RN 4 stated she should not have left the medication unattended and would return the medication to the medication room until she was able to administer the medication to the patient. RN 1 stated the medications should be secured and not left unattended by the staff.
VIOLATION: MAINTENANCE OF PHYSICAL PLANT Tag No: A0701
Based on observation, interview, and record review, the hospital failed to ensure a safe physical environment was provided and maintained in the L&D OR. This created the risk of substandard healthcare outcomes to the patients receiving services in the L&D OR.

Findings:

On 6/17/19 at 1220 hours, EVS 2 was observed cleaning the L&D OR after the completion of a surgical procedure.

At 1310 hours, EVS 2 moved a linen cart located on the back wall of the OR. A circular hole measuring approximately 1 inch around was observed in the floor that was previously obstructed by the cart. EVS 2 and Tech 2 stated they had not seen this hole before.

Several smaller circular indentations were also noted in the front of the OR near the OR table. Tech 2 stated these had been there "for a while" and they were caused by the chair legs pushing into the floor. The floor was visibly cracked in these areas and Tech 2 verified the crack by touching the floor.

During a follow up interview with Director 3 at 1400 hours, the Director stated the EVS staff had the ability to put in a work order if they see broken equipment or physical plant concerns during cleaning; however, no work orders had been initiated for the hole or the indentations in the floor for this OR.

During the Infection Control Committee meeting on 6/19/19 at 0830 hours, Director 6 was asked how often environmental rounds were conducted in the L&D ORs. Director 6 replied "twice per year." Director 6 produced a copy of the last documented rounds for the L&D OR dated 3/1/19. The document showed "no findings."
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview, and record review, the hospital failed to ensure their infection control program evaluated and implemented a hospital wide infection control prevention program with a system in place for the surveillance, prevention, and control of infections as evidenced by:

1. The OR cleaning, between cases, did not follow the hospital's P&P.

2. Two EVS staff did not complete their annual skills training that included infection control.

3. Staff and visitors in the NICU did not follow the hospital's hand hygiene P&P.

4. The NICU was not maintained in a sanitary condition.

These failures posed the potential of the spread of infections.

Findings:

1. Review of the hospital's P&P titled OR/Invasive Procedure/L&D Room Cleaning Version 6.01.2017, showed the process for cleaning the OR between cases. The initial step showed the following:

Performed proper entrance to the OR suite:
* Change the room status to "in progress"
* Place cart at threshold of door with wet floor sign
* Check for isolation signs
* Perform hand hygiene
* Put on appropriate Personal Protective Equipment (PPE), if isolation

Under the section titled Preparation of Room to be Cleaned, it showed the staff should place trash containers and soiled linen hamper outside of the OR suite in front of the scrub sink.

Under the section titled Room Cleaning: - BLUE Wiper showed to begin disinfecting the room, starting with the surfaces in the perimeter of the room and working your way to the center.

Under the section titled Damp mopping showed dust mop is skipped for OR suites and the staff should use damp mop to mop the area around the perimeter of the bed for a simple case, and to mop outside the perimeter of the bed if visibly soiled for complex cases. It also showed the following:

Mop out: Do Not Enter Room
* EVS staff - door sign changed from dirty to clean
* EVS staff - bottom of other door sign slide to expose WET FLOOR
* Floor dry time is 4-6 minutes

The P&P also listed the products used in cleaning the ORs. The list included disinfectants and their contact times (time the surface has to stay wet with the disinfectant to kill viruses and bacteria) as follows: Oxycide, five minutes; Bru-Tab 6S, four minutes.

Review of the product specification document for the disinfectant Oxycide showed a five minute contact time was necessary to kill the hepatitis B and hepatitis C viruses.

Review of the hospital's P&P titled Hand Hygiene dated 5/19 showed when washing hands with soap and water, lather the soap and rub hands together vigorously together and scrubbing between fingers, under fingernails, and around the wrists for at least 15 seconds.

On 6/17/19 at 1220 hours, an observation of the between case cleaning in the L&D OR was conducted with Managers 4 and 5. The following was identified:

a. EVS 2 did not place the trash containers or soiled linen containers outside of the OR prior to mopping the floor with the disinfectant cleaner. There was no room sign status for EVS 2 to place "in progress" or identify the room as "dirty" or "clean."

EVS 2 used the Blu-Tab solution to mop the floor. However, there were no WET FLOOR signs present to prevent the staff members from entering the OR prior to the necessary four minutes contact time.

b. In between cleaning, EVS 2 was observed to use the hand gel some of the time between glove changes and other times used the scrub sink to wash with soap and water. When using the scrub sink, it took EVS 2 approximately 10 seconds to wash hands with soap and water, and dry the hands. When asked if this was sufficient, EVS 2 stated "no" and stated they should have used the hand gel or washed thoroughly.

c. The Anesthesia medication cart was noted to be soiled and a rag was observed on top of the cart. When asked if this surface had been cleaned, Tech 2 verified it did not look clean. Tech 1 stated he had already cleaned it. When asked what he used to clean it, Tech 1 stated he used Oxycide. When asked what the wet time was for the Oxycide, Tech 1 stated "about 45 seconds."

2. On 6/18/19 at 1300 hours, the personnel records were reviewed with the Manager of Accreditation, HR Analyst 1, and HR Analyst 2.

Review of the Organizational Annual Training Outline for 2019 showed the curriculum for the Annual Training online included Hand Hygiene and Environmental Cleaning. When asked if this training was mandatory for the EVS employees, HR Analyst 1 stated yes.

Review of EVS 2's training transcript showed the last annual training completed was 4/9/14.

Review of EVS 5's training transcript showed the last annual training completed was 4/9/15.





3. On 6/17/19, an initial tour of the NICU was initiated with CNS 1, CNS 2, and Manager 1. The following was observed:

a. At 0850 hours, upon entering the NICU two scrub sinks with hand washing timers were observed.

When the NICU staff was asked what was the length of time required for hand washing, CNS 1 stated there was no recommended length of time for hand washing.

CNS 1 further stated the timers were functional, however, they were not utilized.

b. Two inch wide red lines were observed on the floor at the patient room entrances and other various locations.

Manager 1 stated the red lines on the floor were to remind the staff and visitors to perform hand hygiene before crossing the line. The staff and visitors were to "gel in and gel out" when entering or exiting the rooms.

A staff member was observed crossing the red line and passing the alcohol based hand gel sanitizer without performing hand hygiene when entering Room 1, Room 2, and Room 3 (a three patient bed room). The staff member proceeded to sit down at the computer workstation and touched the computer without performing hand hygiene with the hand gel sanitizer located on the computer workstation.

RN 1 acknowledged the staff failed to perform hand hygiene (with two available opportunities) after crossing the red line and entering the patient rooms.

c. On 6/17/19 at 1305 hours, two OR staff were observed entering the NICU, walked past the scrub sinks and one alcohol based hand gel dispenser, and crossed the red line; however, both staff did not perform any hand hygiene.

During a concurrent interview with Manager 1, Manager 1 stated the two OR staff were in the NICU "looking for a 'broviac'."

Manager 1 stated the two OR staff were under the impression they were not required to perform hand hygiene since they had "scrubbed" downstairs in their department.

Manager 1 acknowledged the staff failed to perform hand hygiene (with two available opportunities).

d. On 6/17/19 at 1428 hours during a tour of side A of the NICU, a red line was observed on the floor and posted on the wall was a sign indicating to stop and to clean hands before crossing the line.

At 1440 hours, Director 2 and Director 5 were observed entering side A, crossing the red line, walking past one alcohol based hand gel dispenser, and not performing hand hygiene.

During a concurrent interview, Director 2 and Director 5 acknowledged they failed to perform hand hygiene.

e. On 6/18/19 at 0900 hours, RN 3 was observed walking through the NICU main entrance, walked past the scrub sinks and one alcohol based hand gel dispenser, and entered the Nourishment Room (a room used to store breast milk and feeding supplies) without first performing hand hygiene (with two available opportunities).

During a concurrent interview with RN 3, RN 3 acknowledged she failed to perform hand hygiene prior to entering the Nourishment Room.

f. Review of the hospital's P&P titled Dress and Personal Appearance Code, with a revised date of 10/17 showed artificial nails shall not be worn.

On 6/17/19 at 1515 hours, the Hospital Aide was interviewed.

The Hospital Aide stated her job duties included the cleaning and disinfecting of patient care equipment such as "Giraffes" beds, cribs, crib mattresses, breast milk refrigerators, and freezers. The Hospital Aide further stated she also assisted with transporting the patients (e.g., to radiology), setting up for procedures such as circumcisions, keeping the patient rooms stocked with supplies, and setting up beds and rooms for new admissions.

During the interview with the Hospital Aide, the Hospital Aide was observed with nails that were long (approximately 1/4 inch) and beyond the tip of the finger and appeared to be artificial.

On 6/18/19 at 0911 hours, Manager 2 was interviewed and stated she was not aware of any NICU staff with artificial nails. Manager 2 further stated the staff with artificial nails could not work in the NICU.

On 6/19/19 at 0830 hours, during the infection control committee meeting, Manager 1 and Manager 2 acknowledged the Hospital Aide had artificial nails. They further stated the Hospital Aide was under the impression she could have artificial nails since she did not provide direct patient care.

g. Review of the hospital's P&P titled NICU Visitation/Family Centered Care dated 2/17 showed all visitors will comply with the hand washing procedures and cell phone cleaning, as outlined and posted in the NICU entry.

On 6/17/19 at 0830 hours, an initial tour of the NICU was initiated with Manager 1 and RN 1. The following was observed:

A visitor was observed in a patient room texting on her cell phone. On further inspection, the cell phone was not contained within a plastic bag.

The visitor stated upon entering the NICU, visitors were to clean their cell phones with alcohol wipes and place the cell phone into a plastic bag. The visitor stated she was running late today and did clean the cell phone; however, she did not place the phone in a plastic bag. The visitor further stated she needed to contact family members and was texting at the patient's bedside.

RN 1 stated it was the staffs' responsibility to monitor and remind the visitors to perform proper hand and cell phone hygiene.

4a. On 6/17/19 at 0925 hours, a tour of the NICU was conducted with Manager 1 and RN 1. The following was observed:

- Multiple stethoscopes with a patient name-band tightly wrapped around and hanging at the patients' head of the bed

- Multiple patient rooms had window covers that had multiple stains

- Multiple NICU staff identification badges with stickers and/or character pins

- At the patient's bedside, one I-Pad was connected to an I-Pad charger cable made from a porous material

- In the treatment room, one electronic thermometer engraved deeply with the letters "NICU"

In a concurrent interview with Manager 1, Manager 1 acknowledge the findings and stated the condition of the items would make it difficult to disinfect these items.

b. On 6/18/19 at 0911 hours, a tour of the NICU was conducted with Manager 2. The following was observed:

- The Nourishment Room had a cart underneath the countertop that contained multiple beverages (e.g., coffee mugs, to-go cups with straws, open bottles of water) that belonged to the staff. The countertop was used to scan breast milk and place clean feeding supplies.

During a concurrent interview with Manager 2, Manager 2 acknowledged the findings and stated the practice of storing the staff's beverages in the nourishment room had been authorized by the NICU infection preventionist.

c. In a subsequent tour of the NICU conducted with Manager 2, the following was observed:

- Multiple equipment and surfaces had tape and/or gray sticky residue and were not maintained in a sanitary manner (e.g., isolettes/cribs, computers on wheels, breast milk refrigerators, baby scales, cribs, IV and feeding pumps, one lavender "positioner," one Pediascan, pulse oximeters)

- Multiple equipment with cracks (feedings pumps, electronic thermometers)

- Multiple I-Pad charger cables (made from porous material) that were stored in the Medication Room next to the automated dispensing machine

- Multiple electronic thermometers (one was found stored in a transport bag) that had been engraved deeply with the letters "NICU"

In a concurrent interview with Manager 2, Manager 2 acknowledge the patient care equipment was not cleaned and disinfected properly. Manager 2 further acknowledged the condition of the items would make it difficult to disinfect.

d. In the clean supply room, donated hand knitted hats and blankets and home-made blankets and light protectors (sewn by hospital staff) were observed stored and readily available and accessible for use in the NICU.

In a concurrent interview with Manager 2, Manager 2 stated the donated items were not hospital laundered prior to storing them in the clean supply room.

e. Review of the hospital's P&P titled Infection Prevention in the NICU dated 6/19 showed within the patient's immediate environment (crib or isolette) a clean environment should be maintained by separating the "clean from dirty." Portable waste bags should be used to contain dirty items while providing care.

On 6/17/19 at 0830 hours, an initial tour of the NICU was conducted with Manager 1 and RN 1. Waste bags containing various used items including used gloves, cotton balls, gauze, and tape were observed hanging from the patient Giraffe beds in Room 4, Room 5, and Room 6. No staff were observed in the patient rooms and no care was being provided.

On 6/19/19 at 0830 hours, a meeting with the infection control committee was conducted. The committee members were informed of the above findings. CNS 1 stated she was aware the staff used waste bags attached to the patient beds to contain dirty items while providing care. However, CNS 1 further stated the staff were to remove the waste bags from the patients' beds as soon as the care was complete. The waste bags were not to remain attached to the patient beds.

f. Review of the hospital's P&P titled Standard of Care for Neonatal Transport dated 3/13 showed each shift a licensed staff will ensure the transport box is checked, secured, and has a labeled expiration date.

On 6/18/19 at 1035 hours, an inspection of the medication room was conducted with Manager 2.

Four sets of transport boxes were observed (two internal transport sets and two external transport sets). Each transport set contained a supply and medication box and a respiratory box.

Manager 2 stated each shift a nurse was assigned to check the supply and medication box and the RT checked the respiratory box for each transport box set.

Manager 2 stated the nurse was to check the box to ensure it was locked and had a tag with the name and expiration date of the first item to expire noted on the outside of the box.

Once a month a charge nurse would open the box and check the supplies to ensure there were no expired or compromised items.

Review of the expiration tag attached to the outside of Box #1, showed the first items to expire were the blood culture bottles and stopcocks dated 8/19. However, inspection of the contents within Box #1 showed the following:

* one bottle of chlorhexidine gluconate 2% (disinfectant and antiseptic solution) with an expiration date of 7/19 (one month prior to the items documented as first to expire)
* one chest tube drain wrapped in sterile drapes located inside a plastic bag with the entire center portion sliced opened and resealed with three strips of tape

Manager 2 stated the bottle of chlorhexidine gluconate 2% should have been listed on the tag as the first item to expire. Manager 2 further stated the plastic bag surrounding the chest tube should not have been resealed with tape after opening and the chest tube could no longer be considered sterile.

g. In the medication room, the following was observed:

- Three blood warmer tubing sets, used during exchange transfusions, with an expiration date of 4/19.

- One MRI infusion extension set with an expiration date of 10/31/18.

In a concurrent interview with Manager 2, Manager 2 acknowledged the findings and stated she was not sure if the infection preventionists were aware of the recurring findings, in particular the hand knitted and home-made items that were donated by volunteers and sewn by hospital staff.

On 6/19/19 at 0830 hours, during the infection control committee meeting, Director 6 stated the EOC rounds were conducted twice a year for NICU. When asked about the hand knitted and home-made items that were donated and not washed in the hospital laundry, the Medical Director of Infection Prevention stated the hospital did not have a concern with this practice.

When a copy of the most recent NICU EOC documentation was requested, documentation of the 2018 NICU EOC was provided; however, documentation for the most recent (2019) NICU EOC was not received.