HospitalInspections.org

Based on document review, observation, and interview, it was determined that the Hospital failed to ensure an effective Infection Control Program, with adherence to infection control practices and surveillance, was in place. This has the potential to affect all staff, patients and newborns who receive care by the Hospital. As a result, it was determined the Condition of Participation, 42 CFR 482.42, Infection Prevention Control Antibiotic Stewardship was not in compliance.

Findings include:

1. The Hospital failed to conduct a thorough assessment in OR #1 for potential contamination after water build up from condensation and failed to maintain temperature and humidity as required to provide a clean and sanitary environment as the Hospital continued to utilize OB OR #1 room. See A-750 A.

Based on observation, document review and interview, it was determined for 1 of 2 (OB OR #1) Obstetrical Operating Rooms (OB OR), the Hospital failed to conduct a thorough assessment in OR #1 for potential contamination after water build up from condensation and failed to maintain temperature and humidity as required to provide a clean and sanitary environment as the Hospital continued to utilize OB OR #1 room. This has the potential to affect all staff, patients and newborns.

Findings include:

1. A tour of the Obstetrical Unit (OB) was conducted on 9/15/2022 at approximately 2:30 PM with the Manager of Labor and Delivery (E #1) and Director of Operations (E #2). During the tour of the OB operating rooms (OR), OR #1 (available for patient use) was observed to have a piece of Panolam Fiberglass Reinforced Plastic Embossed Wall Panel (insulation board) caulked around the edges covering an exterior wall window. The right and left lower inside casing of the window was observed to be covered with approximately 18-24 inches of visqueen plastic and enclosed with tape (multi-purpose polyethylene film tape). The visqueen was removed from the right side of the window which demonstrated areas of non-painted new plaster. The visqueen was removed from the left side of the window, and brownish-black circular areas which covered approximately a 12 inch by 6-inch area was observed.
A tour of OB OR #2 was conducted and was observed to be under construction and not available for use. The PACU (Post Anesthesia Care Unit) and NICU (Neonatal Intensive Care Unit) Stabilization rooms were observed to have the windows covered with the insulation board. The area around the base of the window, paint appeared to be bubbled and felt moist when touched.

2. During the tour, E #1 stated, "The external window in the OR rooms (OB OR #1 and OB OR #2) had leaked, condensation would build up, turn into ice in the winter, then water would pool on the windowsill. The paint then peeled, and the air was able to get through, making the rooms cold. The temperature and humidity levels were hard to control. The insulation board over the windows was installed in 2019." E#1 stated that a mold test was done on OB OR #2 during construction, but E #1 did not know the results. E #1 stated, "Labor and Delivery room #7 also has one of two of the windows covered with insulation board for the same reason." E #1 stated, "since mid-August 2022, OB OR #2 was closed for construction and OB OR #1 was only used for emergencies from mid August to current. The scheduled c-sections are now conducted in the general surgery operating rooms." E #1 could not provide an exact date of when the leak was identified/issues with temperature and humidity began in OR #1.

3. An interview was conducted with the Quality and Safety Coordinator (E #8) and Infection Preventionist (E #11). E #8 stated, "We had noticed an increase in post-operative infections so we started tracking the infections in January. I, and the infection preventionist had been doing rounds since the beginning of the year. We received a report from (OB Surgical Technician) on 5/25/2022 with a concern for mold in the OB OR rooms. We increased those rounds when the concern was brought to us. We checked for condensation on the OB packs and sterile storage areas. We checked the windows for water and looked at the OR containments to make sure facilities does not need to re-tape the visqueen. We did not see any mold while doing rounds. We did not look behind the tape and plastic. There is not much documentation on the rounds conducted."

4. An interview was conducted with the Chief Nursing Officer (E #3) on 09/16/2022. E #3 stated, "Facilities put up a moisture barrier months prior to August. It was put up as a protective measure due to condensation buildup. On August 10th I was made aware of conversations regarding the possibility of mold. The facility had been testing for mold frequently and had been negative. I had messaged the Director. That morning I was told the Director did not see anything. Then we found out that staff had pulled the tape back and found mold. Leadership and facilities personnel went to the OR room (OB OR #2). Facilities pulled back tape and found the black substance. We immediately shut down the OR when we found out. Made a mitigation plan and moved scheduled cesarean sections to OR #1 with the hospital's main OR as a backup as of August 11th. We had a meeting with administration and authorized the use of funds to wall off windows."

5. The hospital could not provide any documentation as to when the leak began or when the insulation boards were placed. Interviews indicated varying dates (between November 2021 up until January 2022). The timeframe could not be determined when the concerns were identified in OB OR #1.

6. Work orders were reviewed. The work order, dated 01/09/2022, stated, "c/s room 2 (OB OR #2) is too hot ... Delivery room (OB OR #1 and OB OR #2) are too warm ... Supply air temp overridden and set to 70 degrees."
The work order, dated 05/10/2022, stated the "humidity in L&D OR#1 is currently at 63% and the temp is holding steady at 68 degrees F. We are now not able to use this OR due to humidity exceeding the upper limit of 60%. (E #1) have been monitoring this since 8AM and the system is not automatically increasing the temperature to decrease the humidity. We need help getting the humidity down as soon as possible for patient safety."

7. The policy titled Temperature and Humidity Control of Peri-Procedural Areas and Sterile Storage (effective 03/17/2020) was reviewed. The policy stated, "Policy Temperature 1. Temperature of Operating Rooms ... is designed for control between 68 degrees F to 75 degrees F .... Relative Humidity 3. Relative humidity range of operating rooms ... is 'designed' for control between 30% and 60%..."

8. The Temperature and Humidity logs for OB OR #1 were reviewed on 09/16/2022. The logs indicated the following dates were outside of the acceptable ranges:
OB OR #1 - Humidity less than 30% on 03/13/2022, 04/09/2022, 04/11/2022, and 06/03/2022. Humidity greater than 60% on 05/10/2022, 05/12/2022, 06/12/2022, 06/13/2022, 07/11/2022, 08/03/2022, and 08/04/2022. One procedure was performed on 05/12/2022 on a date when the humidity was out of range. However, OR #1 was available for emergency use on all of the dates.

9. A review of log of OB OR cases from 08/15/2022 - 09/15/2022 was conducted on 9/16/2022. The log stated there was 49 surgical cases after OR #2 was closed for construction. 12 of the cases (08/15/2022, 08/23/2022, 08/25/2022, 09/01/2022 x 2, 09/04/2022, 09/09/2022, 09/11/2022, 09/12/2022, 09/14/2022 x 3) were conducted in OB OR #1 while the rest were conducted in the main hospital OR. The temperature and humidity were within in range in OR #1 on the dates of these 12 cases. However, the window issues and insulation board was in place during these dates.

10. An OB surgical site infection log was reviewed which indicated there were 6 surgical site infections between 06/01/2022 and 09/01/2022. Four of the six cases were performed in OB OR #2 with two of them being performed in OB OR #1.

11. The Mold Project Management Report (Airborne Mold Spore Testing) for C-section delivery room 2 (OB OR #2) dated 08/25/2022 and 08/26/2022 was reviewed. The report stated, "Executive Summary: .... Mold growth was discovered on drywall in Room 5218 (OB OR #2), of the subject building. After remediation activities were complete, clearance air samples were collected on August 5th and 6th 2022. On August 6th, post-remediation air samples met clearance criteria .... August 5th, 2022 ...Comments (page 10) 7:00 PM Results are received from the lab. Both containments did not meet clearance criteria .... (Construction Contractor) informs (Environmental Consulting Service) that they will reclean both containments tonight ... August 26th (page13) Comments 6:00 PM, Results are received from the lab. Both containments pass clearance criteria." There was no Mold Management Report completed for OR#1.

12. An interview with the Environmental Health and Safety Manager (E #10) was conducted on 09/16/2022 at approximately 10:00 AM. E #10 stated "If we suspect material, we remove and identify. We typically would not take down the barrier until we were ready to proceed with remediation/construction. We conduct mold testing once construction is complete. OR #1 has not had any mold testing conducted. Then we complete a terminal cleaning before the room is put back into service. The plan is to do construction in PACU and then move on to OR #1."