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Based on observation, interviews and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The hospital did not have a process in place to ensure work performed under contract is provided in a safe and effective manner. Modifications were made to the air conditioning and ventilation system without the hospital assessing the effects on the air quality flowing into the hospital. (refer to A 84)

2. The hospital did not ensure the air quality coming through the air conditioning unit was safe and the environment was sanitary. Modifications were made to the air conditioning and ventilation system which resulted in introduction of dirty air flowing into Operating Rooms 1 and 2; Patient Rooms 225, 227, 229, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241; and Sterile Processing Area. (refer to A 724)

3. An effective infection prevention program was not implemented and maintained to provide a safe and sanitary environment. (refer to A 749)

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

Based on observation, interview, and document review, the governing body failed to have a process in place to ensure work performed under contract is provided in a safe and effective manner when a local company (LC) was contracted to service and modify Air Handler Unit (AHU) 2 without the benefit of oversight by qualified professional or the state agency (Office of Statewide Planning and Development - OSHPD) authorized to permit hospital equipment modifications. LC performed a service requested by the hospital on AHU 2 on 9/7/17, which caused modifications to negatively affect the quality of air distributed by AHU 2.

These failures resulted in the distribution of air by AHU 2 from an unclean source, through the ventilation duct system leading to Operating Rooms (OR) 1 and OR 2 and servicing Patient Rooms (PR) 225, 227, 229, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, and the Sterile Processing Area (SPA). These failures resulted in the potential to distribute harmful, fine particulate matter into the air in OR's and patient care areas, expected to be sterile and sanitary. These failures resulted in the potential to increase the risk of cross contamination during surgery for 133 patients having surgery between 9/7/17 and 10/4/17 in ORs 1 and 2.


Findings:

On 10/5/17 at 3:45 p.m., during a concurrent group interview, the Director of Facilities (DF), Chief Executive Officer (CEO), and Chief Nursing Officer (CNO) stated they were aware a Local Company (LC) was contracted to make modifications to AHU 2. The DF stated the problem with AHU 2 began around May or June, 2017 and the LC was contracted to perform corrections. DF stated LC was first contracted to make simple corrections such as cleaning the coils. DF stated the problem with AHU 2 was that the equipment was not draining moisture and condensation properly. CNO stated hospital staff first noted water leaks and damage to the wall and corridor of the surgery area around May or June, 2017 and notified DF of the problem. DF stated that LC was contracted to perform more extensive corrections about one month ago (9/7/17). DF stated he did not supervise the work and assumed the work conducted by LC was supervised by a mechanical engineer employed by LC. DF stated he was now aware the work performed on 9/7/17 was not supervised by a mechanical engineer. DF stated the corrective measures performed by LC included drilling holes into the moisture collection pan of AHU 2, bypassing the filters of the unit and installing supplemental HEPA filter (filtration component to capture fine dust and particulate matter). DF, CEO, and CNO stated they were notified the changes made on 9/7/17 by LC constituted a modification of the AHU 2 which required a permit from the authorizing state agency, OSHPD. DF stated the OSHPD Compliance Officer (OCO) explained to the hospital that a permit to perform the modifications made to AHU 2 was required. DF stated the OCO explained the effect of the modifications made to AHU 2 resulted in the unit sucking in air from the interstitial space (area and room where the AHU 2 resided) which was not fresh air (from the outside) and therefore constituted potentially dirty air. DF, CEO and CNO stated that prior to the explanation by OCO they were unaware the AHU 2 was distributing air with the potential to contain particulate matter and dirt. The DF stated AHU 2 distributed air to hospital areas including Operating Room 1 and 2, Sterile Processing Area and Patient Care Rooms on the 2nd floor of the hospital. The CNO stated because of the potential risk to patients the hospital stopped having surgeries in OR 1 and 2 on 10/4/17 and moved all patients from the affected patient care areas. CNO and CEO stated OR 1 and OR 2 will not be used for surgeries until AHU 2 is restored to the original, previous configuration and the air quality assured to be clean.

DF was asked to describe the process to determine whether or not work contracted out and performed on equipment needed to be permitted by OSHPD. DF stated in this instance (AHU 2) he assumed the work completed by LC did not require OSHPD oversight and permit because he thought the work was overseen by a mechanical engineer employed by LC. DF stated he did not use a check-off list or manual or protocol to help decide the extent of work needing to be done and whether or not a permit from OSHPD was required. DF stated he did not have a method to determine the work contracted was actually done to building code and that he relied on LC to complete the work. CEO stated he was aware of the decision to make the modifications to AHU 2 but was unaware of the negative effect the changes had on the quality of air distributed by AHU 2. CEO stated DF explained the corrective measures and he approved LC to conduct the work. CEO stated he was aware the hospital did not have a process in place to determine the quality of the work performed by LC on AHU 2. DF and CEO and CNO stated they were aware the decision to conduct the work without the benefit of OSHPD and mechanical engineer oversight in place resulted in the AHU 2 distributing potentially dirty air to OR 1 and OR 2.

On 10/11/17 at 11:08 a.m., during a group interview, the Governing Body Chair (GBC) and Chief Financial Officer (CFO) stated they became aware of the problem with AHU 2 sometime in May or early June 2017. GBC and CFO stated they knew the LC had done repair work, but were not informed those repairs were considered modifications and required OSHPD permit and approval. GBC and CFO stated they were made aware of the repairs by the CEO. GBC and CFO stated they had already budgeted money for repairs because they knew AHU 2 was old and would be needing to be repaired. When the LC performed the repairs, GBC and CFO were made aware they could repair AHU 2 for approximately $10,000, or replace it for approximately $700,000. GBC and CFO stated the hospital already had money budgeted for the remodel of the lobby and that money would be reallocated for AHU 2. GBC and CFO stated the hospital had no policy or system in place to ensure the quality of work performed by LC. GBC and CFO stated they now have developed a new policy that indicates the DF must report all repairs to the CEO and the CEO shall have oversight of all work done by contracted companies.

On 10/4/17 at 1:45 p.m., during a concurrent interview with the DF and OCO, the DF stated AHU 2 had excessive condensation at least two times since May or June, 2017. The DF stated in-house maintenance staff do some servicing (change filters, quick fixes) to AHU 2 and a Local Company (LC) handles all major problems with air handlers. The OCO stated AHU 2 cools 20% of the hospital including operating rooms (OR's 1 and 2) and patient care areas (identify Rooms). The OCO stated AHU 2 coils were severely corroded and moisture from AHU 2 was distributed through the duct system to OR's, patient care areas, and other areas serviced by AHU 2. The OCO stated the moisture from AHU 2 distributed through the supply ducts caused problems (bubbled, cracked, and peeling paint) in the OR 1 and OR 2 corridor. The OCO stated AHU 2 distributed air to OR 1 and OR 2, the corridor area outside the OR's and to patient care rooms on the second floor.

The hospital failed to maintain the building and equipment in a manner to ensure the safety and well being of patients when:

1. The hospital did not ensure the air quality coming through the air conditioning unit was safe. Modifications were made to the air conditioning and ventilation system which resulted in introduction of unclean air flowing into Operating Rooms 1 and 2, Patient Care Rooms (PR) 225, 227, 229, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, and Sterile Processing Area (SPA). (refer to A 724, finding 1, A 710)

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

Based on observation, document review and interview, the facility failed to maintain a safe air quality coming through the air conditioning system. This was evidenced by modifications done on their air conditioning and ventilating system which resulted in introduction of dirty air into the operating rooms and patient care areas. This could result in a hazardous condition caused by circulation of dirty and contaminated air through the patient care areas. This affected two of two floors including 2 of the operating rooms and patient care areas.

NFPA 101 Life Safety Code, 2012 Edition
19.5.2 Heating, Ventilating, and Air-Conditioning.
19.5.2.1 Heating, ventilating, and air-conditioning shall comply with the provisions of Section 9.2 and shall be installed in accordance with the manufacturer's specifications, unless otherwise modified by 19.5.2.2.

9.2 Heating, Ventilating, and Air-Conditioning.

9.2.1 Air-Conditioning, Heating, Ventilating Ductwork, and Related Equipment. Air-conditioning, heating, ventilating ductwork, and related equipment shall be in accordance with NFPA 90A, Standard for the Installation of Air-Conditioning and
Ventilating Systems, or NFPA 90B, Standard for the Installation of Warm Air Heating and Air-Conditioning Systems, as applicable, unless such installations are approved existing installations, which shall be permitted to be continued in service.

NFPA 90A Standard for the Installation of Air-Conditioning and Ventilating Systems, 2012 Edition
4.3.7.1 General. Air supplied to any space shall not contain flammable vapors, flyings, or dust in quantities and concentrations that would introduce a hazardous condition.

Findings:

On 10/6/17, staff members were interviewed and documents for the air handling unit #2 were requested.
At 9:15 a.m., staff stated during an interview that around May or June 2017, Air Handling Unit (AHU) #2 started leaking water into the Operating Suite. After a few repairs, it was discovered the drain pan system was not functioning correctly and a coil needed to be replaced. In September 2017, the facility vendor made corrections to the drain system by drilling 3 holes in the unit's drain pan so liquid could then drain to a secondary pan. On the same day, HEPA filters, a type of mechanical air filter, were added to the side of the air handling unit. The modifications to the AHU were made without approval from the Office of Statewide Health Planning and Development (OSHPD) to ensure compliance to regulations. At 9:50 a.m., staff stated the three holes drilled in the drain pan and the addition of the HEPA filters compromised the function of the AHU intake of air. Staff stated the air was being sucked from the room into the AHU. The air being sucked in from the interstitial space into the system through the three holes was unfiltered. The air was then dispersed into Operating Room1, 2, Sterile Processing Area and the 2nd floor Med Surge area. At 11:21 a.m., during observation of the vents in Operating Room 1, black dirt and dust was observed on and around the vents. At 11:43 a.m., during a staff interview, staff stated the amount of dirty air dispersed into the affected areas was unknown. The facility was in the process of having an Industrial Hygienist run a test on the air quality of the affected areas.

Based on observation, interview, and administrative document review, the hospital failed to ensure equipment was maintained in a manner to ensure an acceptable level of safety and quality when:

1. Air Handler Unit (AHU) 2 was modified from its original specifications and configuration and the hospital did not have a process in place to keep the environment sanitary. The modifications performed to AHU 2 resulted in introduction of unclean air into Operating Rooms (OR) 1 and 2, Patient Care Rooms (PR) 225, 227, 229, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, and Sterile Processing Area (SPA).

These failures resulted in not ensuring a sanitary environment, increased risk for cross contamination of patients having surgery in OR 1 and OR 2, and the potential to distribute unclean particulate matter in the air vent duct system going to OR 1, OR 2, patient care rooms and sterile processing area.

2. Two unlocked procedural carts containing needles and IV (intravenous; in the body's veins) supplies in the Emergency Department (ED) were unsecured and accessible to patients and visitors.

This failure resulted in the potential access of restricted supplies by patients and visitors and insufficient protection from possible injury.

Findings:

1. On 10/4/17 at 2:10 p.m., during an observation of AHU 2 and concurrent interview with the OCO, AHU 2's metal drain pan (pan to catch moisture and water) had reddish-brown, flaky residue and a hole approximately 6 inches by 12 inches and the stuck door required two hands to open. The OCO stated the reddish-brown flaky residue was rust from excessive moisture in AHU 2 and the rust had caused AHU 2's door to stick and the hole in the metal drain pan.

On 10/4/17 at 5:00 p.m., during an interview, DF stated the areas affected by modifications to AHU 2 were OR one, OR two, adjacent corridor area (including OR clerk's office, steam-autoclave storage room), and patient care rooms 225, 227, 229, and 231 through 241 (total 14 patient rooms). The DF stated there were nine patients currently in patient care rooms affected by modifications to AHU 2 and he was unaware of the number of patients affected since the holes were cut in AHU 2 (early September, three to four weeks ago).

On 10/5/17 at 3:50 p.m., during an observation and concurrent interview, the Chief Operations Officer (COO) stated the ventilation system for PR's 231, 233, 235 and 237 were serviced by AHU 2. The following observations were made: PR 233 was observed to have four bubbled, cracked floor tiles in the center of the room; five bubbled, cracked tiles in the center of room 231; four bubbled, cracked tiles in the center of room 235; and four bubbled, cracked tiles in the center of room 237. Room 241 had light gray fuzzy residue in a wall vent at the base of the floor. When asked about the bubbled, cracked floor tiles, COO stated the floor tiles were above AHU 2 and she was unsure if the moisture from AHU 2 caused the bubbles and cracks in the floor tiles. When asked about the light gray fuzzy residue in the floor vent in room 241, COO stated, all patients had been moved out of rooms affected by the modifications to AHU 2.

On 10/5/17 at 4:15 p.m., during an observation of PR 233 and concurrent interview with a Maintenance Worker (MW) and COO, light gray fuzzy residue was observed from behind the floor vent panel. Upon removal of the floor vent panel, all four visible sides of the vent duct were covered with light gray fuzzy residue. A paper towel was used to remove the light gray fuzzy residue. COO stated, "That looks like a lot of dust."

On 10/5/17 at 4:25 p.m., during an observation of patient care room 241 and concurrent interview with MW, light gray fuzzy residue was observed from behind the floor vent panel. Upon removal of the floor vent panel, all four visible sides of the vent duct were covered with light gray fuzzy residue. When asked how vents in patient care areas were cleaned and maintained, MW stated floor vents in patient care areas were not removed for cleaning and were only cleaned monthly on the outside. When asked about issues related to AHU 2, MW stated he was aware AHU 2 had leaks a couple months ago. MW stated only ceiling vents in the Intensive Care Unit (ICU) and the Emergency Department (ED) were removed and cleaned last month (September, 2017). MW stated air handlers blow out air through the duct system into patient care rooms through floor vents. MW stated the residue on the inside of the vent panels was from insulation, dust, and dirt particles distributed into patient care rooms by air handlers. MW stated, "Vents should be cleaned inside."

On 10/5/17 at 4:30 p.m., during an interview with the Director of Facilities (DF), when asked about cleaning of the vents in patient care rooms 225, 227, 229, and 231 through 241 (rooms receiving air from AHU 2), DF stated, "I don't think any of those vents have ever been serviced."

On 10/6/17 at 11:15 a.m., during an observation of OR 1 and concurrent interview with the maintenance supervisor (MS), MS removed four 10 inch by 10 inch (approximate) ceiling vent panels and one floor vent panel in OR 1. When vent panel 1 was wiped with a white paper towel, visible grayish residue transferred to the paper towel. OR 1's three remaining ceiling vent panels were removed and wiped with a white paper towel. The paper towel showed visible grayish residue was transferred from OR 1's vent panel 2, vent panel 3, and vent panel 4. Ceiling vent panel 3 was stuck to the ceiling by paint and had to be pried away from the ceiling with a screw driver. A one inch by one-eighth inch piece (approximate) of dried paint with reddish brown residue fell to the floor as vent 3 was pried from the ceiling. The floor vent panel had grayish fuzzy residue on the vent panel and in the duct. The MS stated, "I don't know why the vents are that dirty"; MS stated the vents were taken down monthly, sprayed off, dried, and put back.

On 10/6/17 at 11:30 a.m., during an observation of OR 2 and concurrent interview with the MS, MS removed four 10 inch by 10 inch (approximate) ceiling vent panels and one floor vent panel. When all four ceiling vent panels were wiped with a white paper towel, visible grayish residue transferred to the paper towels from all four ceiling vents. The floor vent panel had grayish fuzzy residue on the vent panel and in the duct. When the top of OR 2's skytron (a moveable overhead light with a jointed extension arm to allow movement) was wiped with a white paper towel, visible grayish residue transferred to the paper towel. MS stated maintenance was responsible for removing vents and ensuring they were clean and the vents in OR 1 and OR 2 should not be dirty. When asked about the last time OR 1 and OR 2 vents had been cleaned, MS stated he was not sure. When asked about the last time OR 1 and OR 2 vents had been painted, the MS stated they had not been painted in a while and were not painted in the last month.

On 10/6/17 at 4:55 p.m., during an interview with the Chief Executive Officer (CEO) and DF, CEO stated the hospital was obtaining the services of an Industrial Hygienist (IH) to test the air quality and also with a LC to assist with repairs to AHU 2 for the purpose of restoring it back its original configuration. The DF stated AHU 2 would be restored back to original specifications and configuration, as close as possible despite modifications (holes cut and non-original HEPA filter) made to AHU 2. DF stated AHU 2 will continue to have condensation problems especially in hot weather. DF stated the IH was also asked to test the cracked, bubbled and peeling paint in OR 1 and OR 2 corridor and in other areas exposed to weather conditions, rain and moisture.

On 10/9/17 at 10:47 a.m., during a concurrent interview and administrative record review, DF was asked to provide air change (Air changes per hour, or air change rate, abbreviated ACH or ACPH, is a measure of the air volume added to or removed from a space) logs. DF stated, no air changes have been monitored in the two years he has been employed at the hospital.

On 10/10/17 at 2:16 p.m. during a group interview, CNO stated no log had been kept of air changes in the OR. CNO stated they kept logs in pharmacy, but not the OR. CNO stated the hospital follows AORN (Association of periOperative Registered Nurses) standards in the OR, but she was not aware of their recommendations for air changes.

On 10/10/17 at 4:20 p.m., during an interview, MW stated about two months ago he was informed AHU 2 would not suck up enough moisture and had leaks. MW stated holes were cut into AHU 2 about two weeks ago by a LC requested to service (repair) AHU 2. MW stated he was directed, during his shift, to check AHU 2 every half hour because the drains were backing up and the water was not flowing. MW stated the holes cut in AHU 2 did not completely resolve issues related to condensation and moisture. MW stated he had observed cracked, bubbled, peeling paint in OR 1 and OR 2 corridor. MW stated de-humidifiers were placed in the OR corridor.

On 10/11/17 at 9:05 a.m., during an interview, DF stated the hospital did not have a written policy on when OSHPD should be contacted for the approval of modifications to the facility equipment. DF stated, when holes were cut into AHU 2 he was aware water would come out but was not aware anything from the interstitial space would be going into the holes. DF stated he was present when the holes were cut into AHU 2.

OCO submitted a report to the hospital dated 10/4/17 titled Construction Advisory Report - Investigation indicating: "Findings: A. AHU 2 had been modified without OSHPD approval as noted below: 1. Changing rotation of air supply fan feeding the intake side of AHU 2 from the roof (100% outside air). 2. Modification of the side of AHU 2 to add a door with integral filter bank (4 filters) drawing air from the interstitial space. 3. Modification of the underside of AHU 2 to incorporate holes through the underside of the unit wall to catch and contain condensate drainage into a newly installed catch tray which was plumbed to drain to a nearby floor drain. This appears to have been done because the original condensate sump [pan] had rusted through and would no longer hold condensate water. B. There is clear evidence of condensate carryover to the supply ducting downstream of AHU 2. There were containment measures in place to try to catch water at duct seams. There was bubbled paint at the ceiling of the Operating Room Corridor where moisture had accumulated from condensate leaking past duct joints during the summer months. Today was a relatively cool day and condensate was not present in the condensate sump. C. There is a compromise of air supply air quality in that the unapproved filter bank draws air from the interstitial space. Additionally the failed internal condensate sump and the holes through the AHU skin create a bypass path which allows a percentage of unfiltered air from the interstitial space to be entrained into the air stream to Operating Rooms #1, #2, and patient care areas on the 2nd floor. D. Modification of the roof mounted air supply fan along with the other modifications made to AHU 2 described above has resulted in no confidence of a proper air balance to the spaces supplied by AHU 2 and possibly some adjacent spaces in the hospital. E. The existing cooling coil associated with AHU 2 is excessively corroded and may be contributing to condensate carryover and restricted air flow. Discussion: [DF] reported the following: [Local company] had made the modifications associated with items #2 & 3 above, about 3 weeks ago after the facility had requested assistance with their condensate drain issue and condensate carryover into the unit supply ducting that had occurred throughout the late spring and summer months. The facility modified the rotation of the supply fan providing outside air Summary: 1. The facility is responsible for conducting work without OSHPD approval (Title 24 Part 1 Section 7-128) 2. Air supply from AHU 2 is not 100% outside air and air quality is potentially compromised. 3. Air Balance is compromised as required by CMC Table 4A. 4. Supply air ducts downstream of AHU 2 may be dirty and possibly contaminated as a result of reduced air quality and condensate carryover mixing together. Resolution/Recommendations: 1. Facility engage a licensed Mechanical Engineer in the State of California to evaluate the situation and provide guidance to return the AHU 2 unit to as designed condition and to mitigate any residual contamination issues as well as the condensate drain and carryover issue. Utilize OSHPD Project Permit process for corrections to AHU (Title 24 Part 1 Section 7-115) and to mitigate this "U" investigative report. 2. An Industrial Hygienist might be engaged to evaluate any duct contamination and or air supply contamination. 3. Facility to consult with Licensing and CDPH to determine and establish any restrictions on OR usage or Patient Care Usage. 4. I have informed and consulted with [Regional Compliance Officer, Coastal Region], [Deputy Division Chief, Northern California], & [FDD Deputy Director]. None agree that it is safe at this time to continue using OR#1 and #2. Evaluation of continued use of other patient care areas are subject to CDPH L&C guidance..."

AORN Recommendation V (2012):

Potential hazards associated with HVAC systems in the practice setting should be identified, and safe practices should be established. The air in a perioperative environment contains microbial-laden dust, lint, skin squames, and respiratory droplets. The number of 9 of 45 microorganisms in the air in an operating room is directly proportional to the number of personnel moving in and around the room. Outbreaks of surgical-site infections have been traced to airborne contamination from colonized health care workers. Heating, ventilation, and air conditioning systems dilute and remove contaminants from the air and control airflow patterns. Key components of an effective HVAC system are proper air quality, air volume changes, and airflow direction. In an operating room or procedural area, proper functioning of these components minimizes the contamination of the sterile field and risk of infection to the patient. A properly functioning HVAC system carries microbial-laden skin squames, dust, and lint away from the sterile field, and removes these contaminants through the exhaust ducts at the periphery. V.a. The quality of air entering the operating rooms should be carefully controlled. The air should be sequentially filtered through two filters. The first filter should be rated as 30% efficient and the second should be 90% efficient. A minimum of 20% of the incoming air (ie, three air changes per hour) should be from the outdoors. Filtered, outdoor air minimizes the reticulation of indoor contaminants within the perioperative area. V.d. The air-exchange rate in the perioperative area should be carefully controlled. The number of air changes per hour is based upon the need to remove microbiological or chemical contaminants from the environment.
The minimum rate of total air exchanges per hour should be maintained at a constant level as follows: Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges.

2. On 10/5/17 at 3:30 p.m., during a concurrent observation and interview, a tour of the facility's Emergency Department with the Director of Emergency Services (DES), the top drawer of a blue procedural cart with a keypad lock was unlocked. No staff member was accessing the cart at that time. The unlocked drawer contained needles, syringes, and razors. DES stated the drawer should be locked when not accessed by staff members. She closed the drawer and attempted to lock the cart. The other drawers locked, but the top drawer remained unlocked. A second procedural cart was located in a patient room near the foot of the gurney. The cart had a manual swinging side-lock bar in the open position. No staff members were accessing the cart at that time. The cart was not self-locking. All drawers were accessible to the patient and visitor. The cart contained needles, syringes and razors. DES stated the cart should be locked, but she did not have the key to lock it.

A hospital policy for procedural carts was requested. The hospital provided a policy and procedure titled "Treatment Carts" dated 6/06 indicated," ... The Treatment Carts are located within each nursing unit thus providing convenient access for the appropriate care provider. These carts are self-locking and can only be accessed with the correct punch code."

Based on observation, staff interview, and document review, the hospital failed to provide a sanitary environment to avoid sources of transmission of infections and communicable diseases and did not have an active program for the prevention, control and investigation of infections and communicable diseases when:

1. Air Handler 2 was not maintained in a manner to ensure dirty air was not distributed into Operating Rooms 1 and 2, Patient Care Rooms 225, 227, 229, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, and Sterile Processing Area. (refer to A 749 finding 1)

2. An effective surveillance and monitoring program was not in place to ensure all staff adhered to hand hygiene protocols and prevention of risk to contamination. (refer to A 749 finding 2)


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

Based on observation, staff interview, clinical and administrative document review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:


1. Air Handler Unit (AHU) 2 was not maintained in a manner to ensure fresh and sanitary air was distributed into Operating Rooms 1, 2 and Patient Care Rooms 225, 227, 229, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, and Sterile Processing Area.

2. An effective surveillance and monitoring program was not in place to ensure all staff adhered to hand hygiene protocols and prevention of risk to contamination.

a. Speech Therapist (SPT) did not perform hand hygiene after taking off gloves when providing treatment for a patient in isolation in accordance with hospital policy and procedure. SPT carried a dirty plate out of the room from a patient in isolation.

b. Medical Doctor (MD) did not perform hand hygiene after providing treatment for a patient in the Intensive Care Unit (ICU).

c. Volunteer (V) did not perform hand hygiene before and after visiting each of four patients in the ICU.

d. Registered Nurse (RN) 2 did not perform hand hygiene while administering a blood transfusion to Patient 30.

e. Certified Nursing Assistant (CNA) 2 did not perform hand hygiene or wear gloves while touching patient room surfaces and linen and walking out of the room.

f. Registered Nurse (RN) 4 did not perform hand hygiene during a medication administration to a patient.

g. Housekeeper (HK) 1 did not perform proper cleaning of an Operating Room (OR) after a surgery in accordance with hospital policy and procedure.

h. An anesthesiologist (ANST) (doctor responsible for administering sedation to patients during surgery) did not cover all of his hair during a surgery in accordance with hospital policy and procedure.

i. HK 2 and 3 did not perform proper cleaning of an Operating Room (OR) after surgery.

j. Security guard (SG) did not wear the proper Personal Protective Equipment (PPE) when assisting a patient in isolation.


These failures had the potential to expose patients to avoidable infections.


Findings:

1. On 10/5/17 at 3:50 p.m., during an observation and concurrent interview, the Chief Operations Officer (COO) stated the ventilation system for PR's 231, 233, 235 and 237 were serviced by AHU 2. The following observations were made: PR 233 was observed to have four bubbled, cracked floor tiles in the center of the room; five bubbled, cracked tiles in the center of room 231; four bubbled, cracked tiles in the center of room 235; and four bubbled, cracked tiles in the center of room 237. Room 241 had light gray fuzzy residue in a wall vent at the base of the floor. When asked about the bubbled, cracked floor tiles, COO stated the floor tiles were above AHU 2 and she was unsure if the moisture from AHU 2 caused the bubbles and cracks in the floor tiles. When asked about the light gray fuzzy residue in the floor vent in room 241, COO stated, all patients had been moved out of rooms affected by the modifications to AHU 2.

On 10/5/17 at 4:15 p.m., during an observation of PR 233 and concurrent interview with a Maintenance Worker (MW) and COO, light gray fuzzy residue was observed from behind the floor vent panel. Upon removal of the floor vent panel, all four visible sides of the vent duct were covered with light gray fuzzy residue. A paper towel was used to remove the light gray fuzzy residue. COO stated, "That looks like a lot of dust."

On 10/5/17 at 4:25 p.m., during an observation of patient care room 241 and concurrent interview with MW, light gray fuzzy residue was observed from behind the floor vent panel. Upon removal of the floor vent panel, all four visible sides of the vent duct were covered with light gray fuzzy residue. When asked how vents in patient care areas were cleaned and maintained, MW stated floor vents in patient care areas were not removed for cleaning and were only cleaned monthly on the outside. When asked about issues related to AHU 2, MW stated he was aware AHU 2 had leaks a couple months ago. MW stated only ceiling vents in the Intensive Care Unit (ICU) and the Emergency Department (ED) were removed and cleaned last month (September, 2017). MW stated air handlers blow out air through the duct system into patient care rooms through floor vents. MW stated the residue on the inside of the vent panels was from insulation, dust, and dirt particles distributed into patient care rooms by air handlers. MW stated, "Vents should be cleaned inside."

On 10/5/17 at 4:30 p.m., during an interview with the Director of Facilities (DF), when asked about cleaning of the vents in patient care rooms 225, 227, 229, and 231 through 241 (rooms receiving air from AHU 2), DF stated, "I don't think any of those vents have ever been serviced."

On 10/6/17 at 11:15 a.m., during an observation of OR 1 and concurrent interview with the Maintenance Supervisor (MS), MS removed four 10 inch by 10 inch (approximate) ceiling vent panels and one floor vent panel in OR 1. When vent panel 1 was wiped with a white paper towel, visible grayish residue transferred to the paper towel. OR 1's three remaining ceiling vent panels were removed and wiped with a white paper towel. The paper towel showed visible grayish residue was transferred from OR 1's vent panel 2, vent panel 3, and vent panel 4. Ceiling vent panel 3 was stuck to the ceiling by paint and had to be pried away from the ceiling with a screw driver. A one inch by one-eighth inch piece (approximate) of dried paint with reddish brown residue fell to the floor as vent 3 was pried from the ceiling. The floor vent panel had grayish fuzzy residue on the vent panel and in the duct. The MS stated, "I don't know why the vents are that dirty"; MS stated the vents were taken down monthly, sprayed off, dried, and put back.

On 10/6/17 at 11:30 a.m., during an observation of OR 2 and concurrent interview with the MS, MS removed four 10 inch by 10 inch (approximate) ceiling vent panels and one floor vent panel. When all four ceiling vent panels were wiped with a white paper towel, visible grayish residue transferred to the paper towels from all four ceiling vents. The floor vent panel had grayish fuzzy residue on the vent panel and in the duct. When the top of OR 2's skytron (a moveable overhead light with a jointed extension arm to allow movement) was wiped with a white paper towel, visible grayish residue transferred to the paper towel. MS stated maintenance was responsible for removing vents and ensuring they were clean and the vents in OR 1 and OR 2 should not be dirty. When asked about the last time OR 1 and OR 2 vents had been cleaned, MS stated he was not sure. When asked about the last time OR 1 and OR 2 vents had been painted, the MS stated they had not been painted in a while and were not painted in the last month.

On 10/9/17 at 10:47 a.m., during a concurrent interview and administrative record review, DF was asked to provide air change (Air changes per hour, or air change rate, abbreviated ACH or ACPH, is a measure of the air volume added to or removed from a space) logs. DF stated, no air changes have been monitored in the two years he has been employed at the hospital.

On 10/10/17 at 2:16 p.m. during a group interview, CNO stated no log had been kept of air changes in the OR. CNO stated they kept logs in pharmacy, but not the OR. CNO stated the hospital follows AORN (Association of periOperative Registered Nurses) standards in the OR, but she was not aware of their recommendations for air changes.

On 10/10/17 at 4:20 p.m., during an interview, MW stated about two months ago he was informed AHU 2 would not suck up enough moisture and had leaks. MW stated holes were cut into AHU 2 about two weeks ago by a LC requested to service (repair) AHU 2. MW stated he was directed, during his shift, to check AHU 2 every half hour because the drains were backing up and the water was not flowing. MW stated the holes cut in AHU 2 did not completely resolve issues related to condensation and moisture. MW stated he had observed cracked, bubbled, peeling paint in OR 1 and OR 2 corridor. MW stated de-humidifiers were placed in the OR corridor.

On 10/11/17 at 9:05 a.m., during an interview, DF stated the hospital did not have a written policy on when OSHPD should be contacted for the approval of modifications to the facility equipment. DF stated, when holes were cut into AHU 2 he was aware water would come out but was not aware anything from the interstitial space would be going into the holes. DF stated he was present when the holes were cut into AHU 2.

OCO submitted a report to the hospital dated 10/4/17 titled Construction Advisory Report - Investigation indicating: "Findings: A. AHU 2 had been modified without OSHPD approval as noted below: 1. Changing rotation of air supply fan feeding the intake side of AHU 2 from the roof (100% outside air). 2. Modification of the side of AHU 2 to add a door with integral filter bank (4 filters) drawing air from the interstitial space. 3. Modification of the underside of AHU 2 to incorporate holes through the underside of the unit wall to catch and contain condensate drainage into a newly installed catch tray which was plumbed to drain to a nearby floor drain. This appears to have been done because the original condensate sump [pan] had rusted through and would no longer hold condensate water. B. There is clear evidence of condensate carryover to the supply ducting downstream of AHU 2. There were containment measures in place to try to catch water at duct seams. There was bubbled paint at the ceiling of the Operating Room Corridor where moisture had accumulated from condensate leaking past duct joints during the summer months. Today was a relatively cool day and condensate was not present in the condensate sump. C. There is a compromise of air supply air quality in that the unapproved filter bank draws air from the interstitial space. Additionally the failed internal condensate sump and the holes through the AHU skin create a bypass path which allows a percentage of unfiltered air from the interstitial space to be entrained into the air stream to Operating Rooms #1, #2, and patient care areas on the 2nd floor. D. Modification of the roof mounted air supply fan along with the other modifications made to AHU 2 described above has resulted in no confidence of a proper air balance to the spaces supplied by AHU 2 and possibly some adjacent spaces in the hospital. E. The existing cooling coil associated with AHU 2 is excessively corroded and may be contributing to condensate carryover and restricted air flow. Discussion: [DF] reported the following: [Local company] had made the modifications associated with items #2 & 3 above, about 3 weeks ago after the facility had requested assistance with their condensate drain issue and condensate carryover into the unit supply ducting that had occurred throughout the late spring and summer months. The facility modified the rotation of the supply fan providing outside air Summary: 1. The facility is responsible for conducting work without OSHPD approval (Title 24 Part 1 Section 7-128) 2. Air supply from AHU 2 is not 100% outside air and air quality is potentially compromised. 3. Air Balance is compromised as required by CMC Table 4A. 4. Supply air ducts downstream of AHU 2 may be dirty and possibly contaminated as a result of reduced air quality and condensate carryover mixing together. Resolution/Recommendations: 1. Facility engage a licensed Mechanical Engineer in the State of California to evaluate the situation and provide guidance to return the AHU 2 unit to as designed condition and to mitigate any residual contamination issues as well as the condensate drain and carryover issue. Utilize OSHPD Project Permit process for corrections to AHU (Title 24 Part 1 Section 7-115) and to mitigate this "U" investigative report. 2. An Industrial Hygienist might be engaged to evaluate any duct contamination and or air supply contamination. 3. Facility to consult with Licensing and CDPH to determine and establish any restrictions on OR usage or Patient Care Usage. 4. I have informed and consulted with [Regional Compliance Officer, Coastal Region], [Deputy Division Chief, Northern California], & [FDD Deputy Director]. None agree that it is safe at this time to continue using OR#1 and #2. Evaluation of continued use of other patient care areas are subject to CDPH L&C guidance..."

AORN Recommendation V (2012):

Potential hazards associated with HVAC systems in the practice setting should be identified, and safe practices should be established. The air in a perioperative environment contains microbial-laden dust, lint, skin squames, and respiratory droplets. The number of 9 of 45 microorganisms in the air in an operating room is directly proportional to the number of personnel moving in and around the room. Outbreaks of surgical-site infections have been traced to airborne contamination from colonized health care workers. Heating, ventilation, and air conditioning systems dilute and remove contaminants from the air and control airflow patterns. Key components of an effective HVAC system are proper air quality, air volume changes, and airflow direction. In an operating room or procedural area, proper functioning of these components minimizes the contamination of the sterile field and risk of infection to the patient. A properly functioning HVAC system carries microbial-laden skin squames, dust, and lint away from the sterile field, and removes these contaminants through the exhaust ducts at the periphery. V.a. The quality of air entering the operating rooms should be carefully controlled. The air should be sequentially filtered through two filters. The first filter should be rated as 30% efficient and the second should be 90% efficient. A minimum of 20% of the incoming air (ie, three air changes per hour) should be from the outdoors. Filtered, outdoor air minimizes the reticulation of indoor contaminants within the perioperative area. V.d. The air-exchange rate in the perioperative area should be carefully controlled. The number of air changes per hour is based upon the need to remove microbiological or chemical contaminants from the environment.
The minimum rate of total air exchanges per hour should be maintained at a constant level as follows: Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges.

2. a. On 10/9/17 at 1:40 p.m., during a concurrent observation and interview in the Intensive Care Unit (ICU), SPT was observed doing a swallowing evaluation ( A pass/fail procedure to identify individuals who require a comprehensive assessment of swallowing function or a referral for other professional and/or medical services) of Patient (Pt) 5 in ICU room 306. There was a Contact Precautions (to prevent the spread of infections, diseases, or germs caused by touching the patient or items in the room) sign posted outside the door. The signage for Contact Precautions indicated the need for hand hygiene (Washing hands with soap and water or use of hand sanitizer foam), a gown, and gloves prior to entering the room. SPT completed her evaluation, took her gown and gloves off, picked up a dirty plate off Pt 5's bedside table, and exited the room, without performing hand hygiene. After exiting ICU Room 306 without performing hand hygiene, SPT walked around the nurse's station carrying the dirty plate in her hand. The Director of Intensive Care Unit (DICU) asked SPT what she was doing with the dirty plate; SPT stated she was looking for the dirty utility room. SPT was asked if she performed hand hygiene before she exited the room and SPT stated no she did not, perform hand hygiene but she should have. SPT was asked if she should have carried a dirty plate out from an isolation room, SPT stated, "No." DICU validated SPT should have performed hand hygiene after removing her gloves and that she should not have carried a dirty plate out from the room. The Manager of Inpatient Therapy stated, "Anything in an isolation room is considered dirty and should not be brought out of the room by therapists."

b. On 10/9/17 at 2:15 p.m., during a concurrent observation and interview in the Intensive Care Unit, MD was observed in room 308 assisting Respiratory Therapy with care for Pt 11. MD took his gloves off, exited the room, shook hands with a staff member walking by, then touched the workstation on wheels computer screen that Registered Nurse (RN) 1 was working on outside of the room. MD did not perform hand hygiene after removing his gloves. MD then returned to room 308 and did not perform hand hygiene or put on a new pair of gloves before resuming care for Pt 11. RN 1 noticed MD was being observed and whispered to MD, "Gel your hands." MD immediately put hand sanitizing gel on his hands and exited the department. RN 1 was asked if she had to tell MD to put hand sanitizer on, she replied, "Yes." MD exited the department before an interview could be conducted. DICU validated MD did not perform hand hygiene after taking gloves off or prior to re-entering the room. DICU stated, "He should have performed hand hygiene, he did not do it."

c. On 10/11/17 at 10:26 a.m., during a concurrent observation and interview in the ICU, Volunteer (VOL) entered room 308 and held Pt. 11's hand while praying together. VOL did not perform hand hygiene, prior to touching Pt 11. VOL used hand sanitizing gel when she exited room 308. VOL then entered room 307, held the patient's hand while praying, and exited the room without performing hand hygiene. VOL then entered room 304, touched patient's arm, and exited room without performing hand hygiene. VOL then wiped her nose with a tissue, and entered room 302 without performing hand hygiene. DICU validated VOL did not perform hand hygiene before entering or exiting all but one of the ICU rooms. DICU stated, "She's been here a long time, she should know the process." VOL stated she knew she was supposed to use hand sanitizer before entering and upon exiting patient rooms, but she did not do so this time.

d. On 10/10/17, at 11:31 a.m., during a concurrent interview and observation of a blood transfusion for Patient 30, RN 2 put on gloves to take the vital signs prior to starting the transfusion. When RN 2 was done taking the vital signs, she removed her gloves. RN 2 documented temperature, pulse rate, respiratory rate and blood pressure on the computer. RN 2 put on another pair of gloves without performing hand hygiene, and resumed patient care. DICU validated RN 2 did not perform hand hygiene after removing gloves and putting on the second pair and stated, "She should have used hand gel." RN 2 stated she should have performed hand hygiene after taking off one pair of gloves and putting on the next pair.

e. On 10/10/17, at 2:54 p.m., during a concurrent observation and interview, Certified Nursing Assistant (CNA) 2 entered Room 209 where two patients were located. CNA 2 then walked over to bed 2, at the patient's bedside and in the patient storage closet. CNA 2 then went to the other patient's bed and removed bedding. CNA 2 walked out of the room carrying the dirty linen. CNA 2 performed the activities without hand hygiene and without donning gloves. CNA 2 stated "I should have gelled between contact from one patient area to the other." CNA 2 stated she could have caused contamination by not performing hand hygiene.

f. On 10/11/2017, at 10:12 a.m., during a concurrent observation and interview, RN 4 was preparing medications outside the room with another nurse, RN 5. They entered the room without performing hand hygiene. RN 4 put on gloves and administered the oral medications to the patient. RN 4 did not perform hand hygiene prior to medication administration. Quality Analyst (QA) who was also observing the medication administration validated that neither RN 4 nor RN 5 performed hand hygiene prior to administering medications and that they should have.

On 10/10/17 at 2:16 p.m., during a group interview with the Infection Control Practitioner (ICP), the CNO and Director of Quality (DQ), they stated the hospital did not have an official ICP since 5/17. The CNO stated that she and the DQ were sharing the role of ICP until the current ICP was hired on 10/2/17. The CNO stated the previous ICP was not very involved with the staff and did not re-inforce policies. The CNO stated she appointed herself to assume Infection Control (IC) duties, when the previous ICP left. The current ICP began employment 10/2/17. The ICP stated she is aware there are many IC issues throughout the hospital. The DQ stated they have been working on hand hygiene with the staff in different departments as one of their Quality Improvement (QI) projects. The DQ stated she knows there is room for improvement with hand hygiene throughout the hospital, and that will be one of the areas of focus with the newly hired ICP.


The hospital policy and procedure titled, "Handwashing Guidelines", dated 7/15, indicated, " ...Policy: Hospital Personnel shall wash their hands to prevent the spread of infections: ...After sneezing, coughing, blowing or wiping the nose or mouth ...Indications For Handwashing and Hand Antisepsis With Alcohol Based Rub ...B. Decontaminate hands before and after having direct contact with patients ..."

The hospital policy and procedure titled, "Handwashing Guidelines", dated 7/15, indicated, "...Indications for Handwashing and Hand Antisepsis with Alcohol Based Rub," I. Decontaminate hands before and after removing gloves ..."

The hospital policy and procedure titled, "Guideline for Isolation Precautions", dated 2/16, indicated, "...3. b. Contact Precautions: ...Remove gloves before leaving the patient's room and wash hands immediately with an antimicrobial agent. After glove removal and handwashing, ensure that hands do not touch potentially contaminated environmental surfaces or items in the patient's room to avoid transfer of microorganisms to other patients or environments..."

g. On 10/9/17 at 4:11 p.m., during an observation, Housekeeper (HK) 1 entered Operating Room (OR) 7 after a surgery took place. She carried a small tub of liquid and multiple white washcloths and placed them on a metal table. HK 1 removed a clear plastic bag from a kick bucket (a medical receptacle on wheels, commonly used in operating rooms) which also contained a red hazardous waste bag. She tied the clear plastic bag in a knot, placed it in the regular waste bag, and removed the waste from the OR. She did not replace the red hazardous waste bag or wipe the kick bucket with the cleaning solution in the small tub.

On 10/9/17 at 4:17 p.m., during an observation, HK 1 wet a washcloth in the liquid, wrung it out, and wiped the tops and sides of the three cushions on the OR table. She placed the cushion from the foot of the OR table wet side down on the top of the middle cushion. She wiped the bottom of the cushion, then wiped the exposed metal framework and replaced the cushion to the original position. She repeated the process with the remaining two cushions and the exposed metal framework under them. She did not allow the cushions or metal framework to dry before returning them to their original position.

On 10/9/17 at 4:20 p.m., during an interview, HK 1 stated the wet time (time a cleaning solution remains wet on a surface) for the solution she used was five minutes. She stated, "That is how I was taught, so that's what I do." She stated if a clear plastic bag was in the red hazardous waste bag, she was taught to remove the clear bag and leave the red bag in the bucket. She stated she did not need to clean the bucket.

On 10/9/17 at 4:23 p.m., during an observation, the OR table was observed to be dry. The total wet time was six minutes.

The hospital policy and procedure titled "OR CLEANING" dated 5/91, revised 8/16, indicated, "... 2. Once the patient has left the room: Empty Trash from all trash containers, wash trash buckets and bases with #5 Germicidal Solution, and replace with clean red bag ... 6. Go back to OR patient bed, and wipe all horizontal surfaces, and vertical surfaces, as needed, with #5 Germicidal Solution. Remove cushions, and clean all sides of the cushions with #5 Germicidal Solution. Dry cushions before placing them back on the OR bed ..."

Manufacturer guidelines for use for cleaning solution used in both ORs, Virex II 256, indicated, "What do I use it on? For use on hard, inanimate, non-porous surfaces such as floors, walls, porcelain, and plastic surfaces in hospitals ... Cautions: To disinfect hard, non-porous surfaces, treated surfaces must remain wet for 10 minutes ..."

h. On 10/11/17, at 10:45 a.m., during an observation, Anesthesiologist (ANST) was observed to have a hospital-provided paper cap covering most of his head. The cap covered the hair above the top of his ears and around his head, leaving approximately two inches of hair exposed below the bottom edge of the cap.

On 10/11/17 at 11:47 a.m., during an interview, ANST stated, "The cap is an option for men with short hair. If the hair is longer [pointing to his collar], then the cap that covers everything is worn. But for people with short hair like me, this cap is an option."

On 10/11/17 at 12:15 p.m., during a group interview, Surgical Services Supervisor (SSS) stated, regarding hair coverings, "Everyone should have all hair covered [in the OR]. If a little is exposed now, then more and more is exposed later. Staff need to cover all of their hair when they are in a restricted area." SSS acknowledged ANST did not have all of the hair on his head covered with the cap he wore.

On 10/11/17 at 4:30 p.m., during an interview, CNO stated disposable surgical caps were okay to use if only a fringe of hair was exposed. She stated a fringe of hair was approximately one inch. CNO stated her expectation was for hair coverings to cover as much hair as possible. She stated, "All hair should be covered. If I see hair exposed I alert staff to cover their hair."

The hospital policy and procedure titled, "Surgical Attire", dated 1/17, indicated, "...Policy: The Operating Room is considered to be a 'controlled environment' consisting of both semi-restricted and restricted areas. The human body is a major source of microbial contamination in this environment. Therefore, all persons entering this area are required to wear surgical scrub attire, which may include scrub clothes, hair coverings, masks, protective eyewear, and other barriers worn to provide a barrier to contamination from personnel to patient ...2. All head and facial hair, including sideburns and neckline must be covered completely with a clean disposable, lint free bouffant, skullcap, or surgical hood...Skullcaps that fail to cover the side hair above the ears and at the nape of the neck should not be worn in the surgical suite. .."

i. On 10/11/17 at 11:51 a.m., during an observation, HK 2 and HK 3 entered the OR after a surgery. The top of the OR table cushions were wiped with wet cloths. The cushions were removed from the OR table and the bottom sides were wiped with the wet cloths. The metal frame of the OR table was wiped with the wet cloths and the wet cushions were placed back on to the wet metal frame. The Velcro straps were wiped with a wet cloth. One end of one strap dropped to the floor. The strap was not cleaned again, and the end of it remained touching the floor.

On 10/11/17 at 11:57 a.m., during an observation, the top of the OR table cushions were observed to be dry.

On 10/11/17 at 12:12 p.m., during a group interview, HK 2 stated the wet time for the cleaner used in the OR was 15 seconds. HK 3 stated, "It says on it the wet time is ten minutes. It is ten minutes."

On 10/11/17 at 12:15 p.m., during an interview, when SSS saw the Velcro strap touching the floor, he stated it should not touch the floor, even after the floor was mopped. He stated the strap and OR table cushions needed to be cleaned again because the wet time was not long enough.

On 10/11/17 at 2:27 p.m., during an interview, with, Housekeeping Supervisor (HKS) and the CNO, HKS stated his expectation of staff is to follow process. HKS stated his staff used Virex 256 to clean surfaces and the surfaces needed to remain wet for five minutes. HKS stated he determined the wet time by the manufacturer's guidelines. He stated when cleaning the OR, his staff should replace the red bags and wipe the kick buckets, even if they were empty. HKS stated monitoring staff to verify appropriate cleaning was done "periodically"; he did not specify an interval of monitoring.


On 10/11//17 at 2:55 p.m., during an interview with the ICP, CNO, and DQ, the CNO stated HKS had received training, "When he was first hired, sometime in the 1990's." The CNO was asked why the HKS did not know what the wet times in the OR should be, she replied, "Maybe he needs a refresher course."

The hospital policy and procedure titled "OR CLEANING" dated 5/91, revised 8/16, indicated " ... Once the patient has left the room: Empty Trash from all trash containers, wash trash buckets and bases with #5 Germicidal Solution, and replace with clean red bag ... Go back to OR patient bed, and wipe all horizontal surfaces, and vertical surfaces, as needed, with #5 Germicidal Solution. Remove cushions, and clean all sides of the cushions with #5 Germicidal Solution. Dry cushions before placing them back on the OR bed... Manufacturer guidelines for use for cleaning solution used in both ORs, Virex II 256, indicated, "What do I use it on? For use on hard, inanimate, non-porous surfaces such as floors, walls, porcelain, and plastic surfaces in hospitals ... Cautions: To disinfect hard, non-porous surfaces, treated surfaces must remain wet for 10 minutes ..."

Manufacturer guidelines for use for cleaning solution used in both ORs, Virex II 256, indicated, "What do I use it on? For use on hard, inanimate, non-porous surfaces such as floors, walls, porcelain, and plastic surfaces in hospitals ... Cautions: To disinfect hard, non-porous surfaces, treated surfaces must remain wet for 10 minutes ..."

j. On 10/9/17 at 1:05 p.m., during an observation and concurrent interview, the Director of ICU stated on admission, Pt 12 was placed in Contact Precautions (to prevent the spread of infections, diseases, or germs caused by touching the patient or items in the room) due to clostridium difficile (a bacterium that causes an infectious form of severe diarrhea) and Droplet Precautions (used for diseases or germs that are spread in tiny droplets caused by coughing and sneezing) due to Methicillin-resistant Staphylococcus aureus (an infection caused by bacteria resistant to many antibiotics). Signs for both isolation precautions were observed prominently on the door to Pt 12's room. The signage for Contact Precautions indicated the need for hand hygiene (Washing hands with soap and water or use hand sanitizer foam), a gown, and gloves prior to entering the room. The signage for Droplet Precautions indicated the need for all of the Contact Precaution PPE and added the need to wear a mask in the room. Director of ICU stated staff, visitors or security personnel entering the room should perform hand hygiene and wear a gown, gloves, and mask.

On 10/10/17 at 8:45 a.m., during an observation and concurrent interview, SG was observed entering Pt 12's room without performing hand hygiene. SG donned a mask and walked to Pt 12's bedside. SG exited the room and removed the mask. SG was asked about the use of PPE. SG stated, "I did not wear a gown, if I stand about five feet away, I don't wear a gown. I didn't need gloves because I didn't touch him." SG stated he did not have any instructions on the use of PPE, but stated, "I know how to read and I should have read the sign and followed the instructions." SG stated, "A lot of times I am just in a mask; that is the most important, right?"

On 10/10/17 at 9:20 a.m., during an interview, DICU stated because the Security staff is contracted with the hospital she is not sure how they are trained. DICU stated it is all of our responsibility to monitor hand hygiene and the use of PPE to ensure the staff, including Security are following the protocols for infection control. DICU stated, "I can see now why we need to make sure the guards know about the patients they are monitoring."

On 10/11/17 at 2:46 p.m., during