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Based on observations at the facility, interviews, review of administrative records, policy and procedures, infection control, and quality assurance documentation, the facility's governing body failed to ensure the necessary functions for safe operation were conducted.

The governing body failed to be aware of the scope of the sewage leak that occurred in the facility on 5/26/15, until survey intervention on 6/29/15. The governing body failed to provide a safe and sanitary physical environment by not properly addressing the sewage leak from 5/26/15 until 6/29/15 (refer to A700, A701, and A724). The governing body failed to ensure the infection control program was aware of the sewage leak from 5/26/15 until 6/29/15 and the infection control program was aware of a rodent problem from 6/30/15 until 7/1/15 (refer to A747 and A749). The governing body failed to ensure the comprehensive quality assessment program improvement (QAPI) program was aware of the scope of the sewage leak from 5/26/15 until 6/29/15 (refer to A263, A286, and A308). The cumulative effect of these systemic problems resulted in the hospital's inability to ensure a safe and sanitary environment.

The findings included:

1. Review of the "Board of Trustees" minutes dated 6/10/15 confirms the issues related to the sewage leak were not brought up to the governing body. The Risk Manager said only patient safety was discussed and it was not the Environment of Care's turn to discuss issues with the governing body at this meeting.
Review of the "Venice Regional Bayfront Health Board of Trustee Bylaws" dated June, 2011 revealed the purpose, goals, and objectives of the Board of Trustees shall be to "a. support, manage and furnish facilities, personnel, and services; b. provide appropriate facilities and services to best serve the needs of patients; ... f. manage or participate in, so far as hospital policy, circumstances and available funds may permit, activities designed to promote the general health of the community; ...and i. maintain a commitment to continued comprehensive quality assurance and quality improvement in all aspects of healthcare provided by the hospital in cooperation with the medical staff, CEO, and hospital personnel."

2. In an interview on 6/29/15, the Director of Plant Operations (DPO) said on 5/26/15 the facility had a sewage leak in the interstitial space above the 2nd floor nursing unit called 2 North. The 2 North unit is a post-surgical orthopedic nursing unit. The interstitial space between the 2nd and 3rd floors was the old building roof before the 3rd and 4th floors were added. The old roof was made of gravel, tar, and particle board layers.

The DPO said this sewage leak was identified by the facility nursing staff on 5/26/15 at approximately 12:30 p.m., when water was leaking from the ceiling and running down several walls of the 2 North, Team 3 nursing unit. The staff visibly identified 3 areas: in the hallway across from patient room #275 and both sides of the hallway by the elevators directly in front of the nursing station. The sewage water leaked down the walls by the elevators and flowed down the 2 North elevator shaft. This caused the elevator electrical to short out. The DPO stated the "sewage water was flowing at a steady pace and required large trash bins to capture the water."

On 6/29/15 at 6:30 p.m., the 2 North Unit Manager said she was present when the sewage leak occurred. She said the water leaked down the walls. The fire doors were closed to contain part of the leak. She said blankets were used to control the water and guide it down the elevator. Water was observed throughout the unit's ceiling tiles and staff was keeping an eye on the lighting fixtures which were filling with water. The unit secretary confirmed this.

3. In an interview on 6/29/15, the DPO said his team immediately went up to the interstitial space and identified the leak was from the 6-inch main sewage line draining the entire 3rd and 4th floors. His team placed a cap on the sewage line to stop the leak. He said they identified the sewage leak was caused by facility staff flushing sanitary wipes, which caused the pipe to burst.
The DPO said he called in an environmental restoration company who arrived on 5/26/15 at approximately 2:00 p.m. to clean up the sewage leak. He stated their job was to "extract, dry up, and clean up any affected areas" in the interstitial space, on the 2nd floor nursing unit, and in the 1st floor back kitchen office. The DPO said when the restoration company came, they placed a visqueen wall "somewhere in the middle of the 2 North Team 3 nursing unit hallway" and in the "back office of the kitchen area." They proceeded to clean up the sewage leak and dry the affected areas. He said the restoration company was in the facility for 5 days and left on 5/30/15. He stated "at no time during the restoration project and cleanup were patients moved." The unit remained open to all patients on the unit and included the physical therapy gym.

The DPO said his supervisor, the Chief Operating Officer (COO), and the Assistant Chief Executive Officer (ACEO) were both aware of the sewage leak when it occurred and that a restoration company would need to come into the facility and clean up the sewage. He also said he discussed the issue the next day, 5/27/15, during the "daily safety huddle."

4. On 6/29/15, observations during a tour of the interstitial space with the DPO found the interstitial space was not properly cleaned up by the restoration company. There was a sewage odor, sanitary wipes and toilet paper were visible, and the floor was still wet. The DPO acknowledged the restoration company should have done a better job cleaning up the interstitial space. The DPO confirmed the raw sewage spill traveled over 80 feet from where the pipe burst to where the elevator shaft was. This 80 foot distance spans almost the entire 2 North, Team 3 nursing unit ceiling. On the 2 North nursing unit, there was still a discoloration observed from the sewage spill on the walls by the elevators.
On 6/29/15 at 12:50 p.m., the DPO said the restoration company told him the problem was fixed, and he did not notice any issues. He said the restoration company did not make further recommendations. He stated "they did no environmental testing within the hospital related to the sewage spill to determine the extent of the problem." An Infection Control Risk Assessment (ICRA) was not completed. The DPO said normally the restoration company does both the environmental testing and the ICRA.
On 7/2/15 at 9:30 a.m., the DPO said he was not sure why the visqueen wall was not put up by the elevators. He said he thought since the sewage water was cleaned up quickly, they did not put up any walls on the end of the unit. He said the restoration company gave him "no concerns" and stated "there is no reason why the ICRA was not done." He confirmed the restoration company normally does them for him and he just signs off on them.

5. In an interview on 6/29/15 at 1:00 p.m., the Risk Manager (RM) said the ICRA was not completed and the infection control nurse was not involved in the process since she was on vacation. She said this leak was not reported to the hospital safety committee when it occurred.

6. On 6/30/15 at 11:10 a.m., a tour of the interstitial space with the Industrial Hygienist (IH) confirmed, based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak on 5/26/15. The industrial hygienist said he will be taking more core samples to determine the extent of the affected areas and create a map of the areas which still need remediation.

7. On 6/30/15 at 4:30 p.m. on a tour of the back kitchen office with the DPO, noises were heard coming from the ceiling tiles and 4 live rodents (rats) were observed above the ceiling tiles. The DPO said he would have pest control come out immediately and evaluate the problem.

8. On 7/1/15 at 2:00 p.m., the Risk Manager stated "no one was aware of the scope [of the sewage leak] until this week." She said she was aware the restoration company was in the building, but "at no time did I think I needed to check on the progress of the project."
She said she was not aware of any issues with rodents in the facility at this time and confirmed she has not had a report from the DPO about any issues with rodents on the 6/30/15 tour. The Risk Manager said routine pest prevention service is completed and confirmed the facility does not have a pest control policy or contract in place.

9. On 7/1/15 at 3:15 p.m., the COO said she was told about the leak by the DPO when the event occurred and the restoration company was in the building. She stated "she was not aware of the scope of events when this happened and thought the issue was handled." She added their focus on the sewage leak was to prevent the leak from occurring again by educating the facility staff to not flush the sanitary wipes. They thought the restoration company was doing their job. She confirms there was no ICRA completed by staff when the visqueen wall went up since no one really understood the scope of the problem.
On 7/2/15 at 8:15 a.m., the COO confirmed she oversees plant operations and stated she "knew of the leak when it happened but as far as she was aware, it was under control." She thought the elevator being closed was the bigger concern. She was not aware the sewage spill was from a main line and went over 80 feet. She said over the past 2 days, the facility was "now aware of the breadth of the situation." She said as of this week, the unit and elevators will remain closed until the environmental testing can be completed. She confirmed she did not involve the Infection Control Director when the decision was made to close the unit on 6/29/15 and she did not talk to the Infection Control Director until earlier this morning to discuss all the issues identified. She said the facility has caught 3 of 4 rodents observed and is working on a long-term pest control plan.

10. On 7/1/15 at 4:20 p.m., the Chief Executive Officer (CEO) stated "we did not know the scope of the issue." He stated the facility "thought we did the right thing and fixed it, but trusted the restoration company too much." He said they did not have any contract in place with the restoration company. He stated the facility "should know when the visqueen wall goes up they will need to have industrial health testing." He said with the Director of Infection Control being out on vacation, the ICRA report was not completed and confirmed the infection control risk for the facility was unknown. He confirmed this issue was not brought up to the governing body to discuss since the scope of the problem was unknown.

11. On 7/1/15 at 4:45 p.m., the Director of Infection Control confirmed she was on vacation during the incident. She said she came back on 7/1/15 and never had a meeting to discuss any issues that occurred while she was gone. She said on approximately 7/7/15 she observed the elevators were closed. Staff told her the "plumbing overflowed and shorted out the elevator." She said she was not even aware the restoration company came into the facility until today. She said her backup left early on 5/26/15 and was never notified about the restoration company either. She confirmed she "was not kept in the loop" when patients were removed from the unit on 6/29/15. She stated she "has not been involved in any infection control projects related to the spill all week." She said she was not aware an industrial hygienist was in the building doing testing this week. She also confirmed she was not even aware a visqueen wall was set up in the kitchen. She said any time a visqueen wall needs to go up, the infection control department should be involved to do the ICRA. She confirmed they were not involved at any point from when the spill occurred on 5/29/15 through 7/1/15. She stated "no one knew the scope of the issue until today." She said she was not aware of any issues with rodents in the facility at this time and confirmed that she has not had a report from the DPO about any rodents seen on the 6/30/15 tour.

12. On 7/1/15 at 6:41 p.m., the Assistant Chief Executive Officer (ACEO) stated he was aware of the sewage leak and a "third party restoration company would be needed to complete the cleanup process." He said he "was not aware an ICRA was required at this point" and everyone just thought it was a normal leak.

13. On 7/2/15 at 9:30 a.m., the Risk Manager stated "no one ever thought to get the infection control involved since no one was aware of the scope of the issue." She said this issue was discussed in the daily huddle on 5/27/15, and also the environment of care meeting on 5/28/15, but added the focus was on the cause of the leak and the elevators being shut down. She stated "no one thought to determine if the cleanup was handled correctly."
The "safety huddle sign in sheet" dated 5/27/15 documents the CEO, ACEO, Chief Quality Officer (CQO), RM, DPO, and the Director of Dietary were all present during the meeting. Review of the "daily safety huddle record" revealed the leak was discussed and "plant ops staff were recognized for responding to the major leak so quickly."
The Environment of Care Committee reports to the governing board. Review of the Environment of Care Committee minutes dated 5/28/15 revealed "we had a sewer pipe leak due to wipes being flushed down toilets. North Elevators have been shut down for repair due to this leak."

14. On 7/2/15 at 10:55 a.m., the CQO confirmed she oversees the infection control department. She said she was not made aware of the issue until the safety huddle on 5/27/15. She stated "the concern was to prevent the issue from re-occurring" and "the facility did not consider this an infection control issue." She stated "no one was thinking there was any patient safety issues at this time." She stated "we all just dropped the ball and did not know the extent of the issue." She said both the DPO and the Director of Infection Control should work closely with any restoration projects, and this was not done.

15. Review of the facility's Construction and Infection Control Risk Assessment policy (number IC-16-01, last reviewed 1/15) revealed the purpose was "once implemented, should minimize the risk of infection, discomfort or other outcome detrimental to a patient's course of recovery." The policy states "construction, demolition, or repair projects may impact the environment and health of staff, physicians, visitors, and patients. This impact may be creating and releasing airborne particles, disrupting power or medical gases, loss of sewage containment." The procedure states "on an as needed basis plant operations will notify the standing participants involved in all assessments of upcoming projects. Standing participants are Infection Control Director, Director of Risk Management and Safety Officer." It goes on to say "the daily administrative huddle ...may be an appropriate forum for this weekly notification."
The Construction and Infection Control Risk Assessment policy defines a Type C project as "any activity which cannot be completed within a single work shift" and the patient risk group as "high risk" based upon it being a medical unit. This would make the project a Class III/IV project. The policy states an "ICRA permit signed by all of the standing participants is required" and "during off-hours a telephone consult with infection control may suffice until a formal discussion can be held."
On 7/2/15 at 10:55 a.m., the CQO confirmed the policy was not followed and an ICRA should have been completed. She said if the scope of the issue was properly identified during the Environment of Care meeting on 5/28/15, they could have had an "emergency meeting" with the governing board to make them aware of the issues within the facility. She stated "this was not done since the facility was unaware of the scope of the issue."

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Based on observations at the facility, review of administrative records, policy and procedures, and infection control and quality assurance documentation, the facility's governing body failed to ensure the Quality Assessment Program Improvement (QAPI) program was on-going, hospital-wide, and involved all hospital departments.

The governing body failed to be aware of the scope of the sewage leak that occurred in the facility on 5/26/15, until survey intervention on 6/29/15. The governing body failed to ensure the QAPI program was aware of the scope of the sewage leak from 5/26/15 until 6/29/15 (refer to A286) and involved all hospital departments ( refer to A308). The cumulative effect of these systemic problems resulted in the hospital's inability to ensure a safe and sanitary environment.

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Based on observations at the facility, review of administrative records, policy and procedures, and infection control and quality assurance documentation, the facility's governing body failed to ensure the scope of the Quality Assessment Program Improvement (QAPI) program. The QAPI program was not involved in actions to implement preventative measures to protect the patients and staff from a sewage leak within the facility.

The findings included:

1. In an interview on 7/2/15 at 10:55 a.m., the Chief Quality Officer (CQO) said the hospital's quality improvement program has 3 committees who address concerns to the Board of Trustees (the governing body) on a rotating, monthly basis. The 3 committees are Safety, Quality, and Risk. The hospital also has several subcommittees who meet and coordinate their findings to the QAPI program by addressing concerns with their respective committees. Two subcommittees that report to the Quality Committee would be the Environment of Care and Infection Control Committee. Each committee has meetings on a monthly basis, but their area only presents their findings to the Governing Board on a quarterly basis unless it is an emergency. The CQO said the hospital did not bring the sewage leak to their QAPI program at the 6/10/15 Board of Trustee meeting since "the facility was unaware of the scope of the issue." The Risk Manager and the Chief Executive Officer (CEO) also confirmed the sewage leak was not addressed by the hospital's QAPI program since the scope was unknown.

2. In an interview on 6/29/15, the Director of Plant Operations (DPO) said on 5/26/15 the facility had a sewage leak in the interstitial space above the 2nd floor nursing unit called 2 North. The 2 North unit is a post-surgical orthopedic nursing unit. The interstitial space between the 2nd and 3rd floors was the old building roof before the 3rd and 4th floors were added. The old roof was made of gravel, tar, and particle board layers.

The DPO said this sewage leak was identified by the facility nursing staff on 5/26/15 at approximately 12:30 p.m., when water was leaking from the ceiling and running down several walls of the 2 North, Team 3 nursing unit. The staff visibly identified 3 areas: in the hallway across from patient room #275 and both sides of the hallway by the elevators directly in front of the nursing station. The sewage water leaked down the walls by the elevators and flowed down the 2 North elevator shaft. This caused the elevator electrical to short out. The DPO stated the "sewage water was flowing at a steady pace and required large trash bins to capture the water."

On 6/29/15 at 6:30 p.m., the 2 North Unit Manager said she was present when the sewage leak occurred. She said the water leaked down the walls. The fire doors were closed to contain part of the leak. She said blankets were used to control the water and guide it down the elevator. Water was observed throughout the unit's ceiling tiles and staff was keeping an eye on the lighting fixtures which were filling with water. The unit secretary confirmed this.

3. In the interview on 6/29/15, the DPO said his team placed a cap on the sewage line to stop the leak and called in an environmental restoration company to clean up the sewage leak. They proceeded to clean up the sewage leak and dry the affected areas. He said the restoration company was in the facility for 5 days. He stated "at no time during the restoration project and cleanup were patients moved." The unit remained open to all patients on the unit and included the physical therapy gym.

4. On 6/29/15, observations during a tour of the interstitial space with the DPO found the interstitial space was not properly cleaned up by the restoration company. There was a sewage odor, sanitary wipes and toilet paper were visible, and the floor was still wet. The DPO acknowledged the restoration company should have done a better job cleaning up the interstitial space. The DPO confirmed the raw sewage spill traveled over 80 feet from where the pipe burst to where the elevator shaft was. This 80 foot distance spans almost the entire 2 North, Team 3 nursing unit ceiling. On the 2 North nursing unit, there was still a discoloration observed from the sewage spill on the walls by the elevators.

On 6/29/15 at 12:50 p.m., the DPO said the restoration company told him the problem was fixed, and he did not notice any issues. He said the restoration company did not make further recommendations. He stated "they did no environmental testing within the hospital related to the sewage spill to determine the extent of the problem." An Infection Control Risk Assessment (ICRA) was not completed. The DPO said normally the restoration company does both the environmental testing and the ICRA.

5. In an interview on 6/29/15 at 1:00 p.m., the Risk Manager (RM) said the ICRA was not completed and the Infection Control Nurse was not involved in the process since she was on vacation. She said this leak was not reported to the hospital's Safety Committee when it occurred.

6. On 6/30/15 at 11:10 a.m., a tour of the interstitial space with the Industrial Hygienist (IH) confirmed, based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak on 5/26/15. The industrial hygienist said he will be taking more core samples to determine the extent of the affected areas and create a map of the areas which still need remediation.

7. On 7/1/15 at 2:00 p.m., the Risk Manager stated "no one was aware of the scope [of the sewage leak] until this week." She said she was aware the restoration company was in the building, but "at no time did I think I needed to check on the progress of the project."

8. On 7/1/15 at 3:15 p.m., the COO said she was told about the leak by the DPO when the event occurred and the restoration company was in the building. She stated "she was not aware of the scope of events when this happened and thought the issue was handled." She added their focus on the sewage leak was to prevent the leak from occurring again by educating the facility staff to not flush the sanitary wipes. They thought the restoration company was doing their job. She confirms there was no ICRA completed by staff when the visqueen wall went up since no one really understood the scope of the problem.

On 7/2/15 at 8:15 a.m., the COO confirmed she oversees plant operations and stated she "knew of the leak when it happened but as far as she was aware, it was under control." She thought the elevator being closed was the bigger concern. She was not aware the sewage spill was from a main line and went over 80 feet. She said over the past 2 days, the facility was "now aware of the breadth of the situation." She said as of this week, the unit and elevators will remain closed until the environmental testing can be completed. She confirmed she did not involve the Infection Control Director when the decision was made to close the unit on 6/29/15 and she did not talk to the Infection Control Director until earlier this morning.

9. On 7/1/15 at 4:20 p.m., the Chief Executive Officer (CEO) stated "we did not know the scope of the issue." He stated the facility "thought we did the right thing and fixed it, but trusted the restoration company too much." He said they did not have any contract in place with the restoration company. He stated the facility "should know when the visqueen wall goes up they will need to have industrial health testing." He said with the Director of Infection Control being out on vacation, the ICRA report was not completed and confirmed the infection control risk for the facility was unknown. He confirmed this issue was not brought up to the governing body to discuss since the scope of the problem was unknown.

10. On 7/1/15 at 4:45 p.m., the Director of Infection Control confirmed she was on vacation during the incident. She said she came back on 7/1/15 and never had a meeting to discuss any issues that occurred while she was gone. She said on approximately 7/7/15 she observed the elevators were closed. Staff told her the "plumbing overflowed and shorted out the elevator." She said she was not even aware the restoration company came into the facility until today. She said her backup left early on 5/26/15 and was never notified about the restoration company either. She confirmed she "was not kept in the loop" when patients were removed from the unit on 6/29/15. She stated she "has not been involved in any infection control projects related to the spill all week." She said she was not aware an industrial hygienist was in the building doing testing this week. She also confirmed she was not even aware a visqueen wall was set up in the kitchen. She said any time a visqueen wall needs to go up, Infection Control should be involved to do the ICRA. She confirmed they were not involved at any point from when the spill occurred on 5/29/15 through 7/1/15. She stated "no one knew the scope of the issue until today."

11. On 7/2/15 at 9:30 a.m., the Risk Manager stated "no one ever thought to get the infection control involved since no one was aware of the scope of the issue." She said this issue was discussed in the daily huddle on 5/27/15 and also the Environment of Care meeting on 5/28/15. She added the focus was on the cause of the leak and the elevators being shut down. She stated "no one thought to determine if the cleanup was handled correctly."
The "safety huddle sign in sheet" dated 5/27/15 documents the CEO, ACEO, CQO, RM, DPO, and the Director of Dietary were all present during the meeting. Review of the "daily safety huddle record" revealed the leak was discussed and "plant ops staff were recognized for responding to the major leak so quickly."

The Environment of Care Committee reports to the governing board. Review of the Environment of Care Committee minutes dated 5/28/15 revealed "we had a sewer pipe leak due to wipes being flushed down toilets. North Elevators have been shut down for repair due to this leak."

12. Review of the facility's Construction and Infection Control Risk Assessment policy (number IC-16-01, last reviewed 1/15) revealed the purpose was "once implemented, should minimize the risk of infection, discomfort or other outcome detrimental to a patient's course of recovery." The policy states "construction, demolition, or repair projects may impact the environment and health of staff, physicians, visitors, and patients. This impact may be creating and releasing airborne particles, disrupting power or medical gases, loss of sewage containment." The procedure states "on an as needed basis plant operations will notify the standing participants involved in all assessments of upcoming projects. Standing participants are the Infection Control Director, Director of Risk Management, and Safety Officer." It goes on to say "the daily administrative huddle ... may be an appropriate forum for this weekly notification."

The Construction and Infection Control Risk Assessment policy defines a Type C project as "any activity which cannot be completed within a single work shift" and the patient risk group as "high risk" based upon it being a medical unit. This would make the project a Class III/IV project. The policy states an "ICRA permit signed by all of the standing participants is required" and "during off-hours a telephone consult with infection control may suffice until a formal discussion can be held."

On 7/2/15 at 10:55 a.m., the CQO confirmed the policy was not followed and an ICRA should have been completed. She said if the scope of the issue was properly identified during the Environment of Care meeting on 5/28/15, they could have had an "emergency meeting" with the governing board to make them aware of the issues within the facility. She stated "this was not done since the facility was unaware of the scope of the issue."

13. Review of the "Board of Trustees" minutes dated 6/10/15 confirmed the issues of the sewage leak was not brought up to the governing body. The Risk Manager said only patient safety was discussed and it was not the Environment of Care's turn to discuss issues with the governing body at this meeting.

14. On 7/2/15 at 10:55 a.m., the CQO confirmed she oversees the infection control department. She said she was not made aware of the issue until the safety huddle on 5/27/15. She stated "the concern was to prevent the issue from re-occurring" and "the facility did not consider this an infection control issue." She stated "no one was thinking there was any patient safety issues at this time." She stated "we all just dropped the ball and did not know the extent of the issue." She said both the DPO and the Director of Infection Control should work closely with any restoration projects, and this was not done.

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Based on observations at the facility, review of administrative records, policy and procedures, and infection control and quality assurance documentation, the facility's governing body failed to ensure the Quality Assessment Program Improvement (QAPI) program involved all hospital departments.

The findings included:

1. In an interview on 7/2/15 at 10:55 a.m., the Chief Quality Officer (CQO) said the hospital's quality improvement program has 3 committees who address concerns to the Board of Trustees (the governing body) on a rotating, monthly basis. The 3 committees are Safety, Quality, and Risk. The hospital also has several subcommittees who meet and coordinate their findings to the QAPI program by addressing concerns with their respective committees. Two subcommittees that report to the Quality Committee would be the Environment of Care and Infection Control. Each committee has meetings on a monthly basis, but their area only presents their findings to the Governing Board on a quarterly basis unless it is an emergency. The CQO said the hospital did not bring the sewage leak to their QAPI program at the 6/10/15 Board of Trustee meeting since "the facility was unaware of the scope of the issue." The Risk Manager and the Chief Executive Officer (CEO) also confirmed the sewage leak was not addressed by the hospital's QAPI program since the scope was unknown.

2. In an interview on 6/29/15, the Director of Plant Operations (DPO) said on 5/26/15 the facility had a sewage leak in the interstitial space above the 2nd floor nursing unit called 2 North. The 2 North unit is a post-surgical orthopedic nursing unit. The interstitial space between the 2nd and 3rd floors was the old building roof before the 3rd and 4th floors were added. The old roof was made of gravel, tar, and particle board layers.

The DPO said this sewage leak was identified by the facility nursing staff on 5/26/15 at approximately 12:30 p.m. when water was leaking from the ceiling and running down several walls of the 2 North, Team 3 nursing unit. The staff visibly identified 3 areas: in the hallway across from patient room #275 and both sides of the hallway by the elevators directly in front of the nursing station. The sewage water leaked down the walls by the elevators and flowed down the 2 North elevator shaft. This caused the elevator electrical to short out. The DPO stated the "sewage water was flowing at a steady pace and required large trash bins to capture the water."

On 6/29/15 at 6:30 p.m., the 2 North Unit Manager said she was present when the sewage leak occurred. She said the water leaked down the walls. The fire doors were closed to contain part of the leak. She said blankets were used to control the water and guide it down the elevator. Water was observed throughout the unit's ceiling tiles and staff was keeping an eye on the lighting fixtures which were filling with water. The unit secretary confirmed this.

3. In the interview on 6/29/15, the DPO said his team capped the sewage line and called in an environmental restoration company. The company proceeded to clean up the sewage leak and dry the affected areas. The DPO said the restoration company was in the facility for 5 days. He stated "at no time during the restoration project and cleanup were patients moved." The unit remained open to all patients on the unit and included the physical therapy gym.

The DPO said his supervisor, the Chief Operating Officer (COO), and the Assistant Chief Executive Officer (ACEO) were both aware of the sewage leak when it occurred. The DPO said he discussed the issue the next day, 5/27/15, during the "daily safety huddle."

4. On 6/29/15, observations during a tour of the interstitial space with the DPO found the interstitial space was not properly cleaned up by the restoration company. There was a sewage odor, sanitary wipes and toilet paper were visible, and the floor was still wet. The DPO acknowledged the restoration company should have done a better job cleaning up the interstitial space. The DPO confirmed the raw sewage spill traveled over 80 feet from where the pipe burst to where the elevator shaft was. This 80 foot distance spans almost the entire 2 North, Team 3 nursing unit ceiling. On the 2 North nursing unit, there was still a discoloration observed from the sewage spill on the walls by the elevators.

On 6/29/15 at 12:50 p.m., the DPO said the restoration company told him the problem was fixed, and he did not notice any issues. He said the restoration company did not make further recommendations. He stated "they did no environmental testing within the hospital related to the sewage spill to determine the extent of the problem." An Infection Control Risk Assessment (ICRA) was not completed. The DPO said normally the restoration company does both the environmental testing and the ICRA.

On 7/2/15 at 9:30 a.m., the DPO said he was not sure why the visqueen wall was not put up by the elevators. He said he thought since the sewage water was cleaned up quickly, they did not put up any walls on the end of the unit. He said the restoration company gave him "no concerns" and stated "there is no reason why the ICRA was not done." He confirmed the restoration company normally does them for him and he just signs off on them.

5. In an interview on 6/29/15 at 1:00 p.m., the Risk Manager said the ICRA was not completed and the Infection Control Nurse was not involved in the process since she was on vacation. She said this leak was not reported to the hospital's Safety Committee when it occurred.

6. On 6/30/15 at 11:10 a.m., a tour of the interstitial space with the Industrial Hygienist confirmed, based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak on 5/26/15. The Industrial Hygienist said he will be taking more core samples to determine the extent of the affected areas and create a map of the areas which still need remediation.

7. On 7/1/15 at 3:15 p.m., the COO said she was told about the leak by the DPO when the event occurred and the restoration company was in the building. She stated she "was not aware of the scope of events when this happened and thought the issue was handled." She added their focus on the sewage leak was to prevent the leak from occurring again by educating the facility staff to not flush the sanitary wipes. They thought the restoration company was doing their job. She confirms there was no ICRA completed by staff when the visqueen wall went up since no one really understood the scope of the problem.

On 7/2/15 at 8:15 a.m., the COO confirmed she oversees plant operations and stated she "knew of the leak when it happened but as far as she was aware, it was under control." She thought the elevator being closed was the bigger concern. She was not aware the sewage spill was from a main line and went over 80 feet. She said over the past 2 days, the facility was "now aware of the breadth of the situation." She said as of this week, the unit and elevators will remain closed until the environmental testing can be completed. She confirmed she did not involve the Infection Control Director when the decision was made to close the unit on 6/29/15 and she did not talk to the Infection Control Director until earlier this morning.

8. On 7/1/15 at 4:20 p.m., the CEO stated "we did not know the scope of the issue." He stated the facility "thought we did the right thing and fixed it, but trusted the restoration company too much." He said they did not have any contract in place with the restoration company. He stated the facility "should know when the visqueen wall goes up they will need to have industrial health testing." He said with the Director of Infection Control being out on vacation, the ICRA report was not completed and confirmed the infection control risk for the facility was unknown. He confirmed this issue was not brought up to the Governing Body to discuss since the scope of the problem was unknown.

9. On 7/1/15 at 4:45 p.m., the Director of Infection Control confirmed she was on vacation during the incident. She said she came back on 7/1/15 and never had a meeting to discuss any issues that occurred while she was gone. She said on approximately 7/7/15 she observed the elevators were closed. Staff told her the "plumbing overflowed and shorted out the elevator." She said she was not even aware the restoration company came into the facility until today. She said her backup left early on 5/26/15 and was never notified about the restoration company either. She confirmed she "was not kept in the loop" when patients were removed from the unit on 6/29/15. She stated she "has not been involved in any infection control projects related to the spill all week." She said she was not aware an industrial hygienist was in the building doing testing this week. She also confirmed she was not even aware a visqueen wall was set up in the kitchen. She said any time a visqueen wall needs to go up, the infection control department should be involved to do the ICRA. She confirmed they were not involved at any point from when the spill occurred on 5/29/15 through 7/1/15. She stated "no one knew the scope of the issue until today."

10. On 7/2/15 at 9:30 a.m., the Risk Manager stated "no one ever thought to get the infection control involved since no one was aware of the scope of the issue." She said this issue was discussed in the daily huddle on 5/27/15 and also the Environment of Care meeting on 5/28/15. She added, the focus was on the cause of the leak and the elevators being shut down.

The "safety huddle sign in sheet" dated 5/27/15 documents the CEO, ACEO, CQO, RM, DPO, and the Director of Dietary were all present during the meeting. Review of the "daily safety huddle record" revealed the leak was discussed and "plant ops staff were recognized for responding to the major leak so quickly."

Review of the Environment of Care Committee minutes dated 5/28/15 revealed "we had a sewer pipe leak due to wipes being flushed down toilets. North Elevators have been shut down for repair due to this leak."

11. On 7/2/15 at 10:55 a.m., the CQO confirmed she oversees infection control. She said she was not made aware of the issue until the safety huddle on 5/27/15. She stated "the concern was to prevent the issue from re-occurring" and "the facility did not consider this an infection control issue." She stated "no one was thinking there was any patient safety issues at this time." She stated "we all just dropped the ball and did not know the extent of the issue." She said both the DPO and the Director of Infection Control should work closely with any restoration projects, and this was not done.

12. Review of the facility's Construction and Infection Control Risk Assessment policy (number IC-16-01, last reviewed 1/15) revealed the purpose was "once implemented, should minimize the risk of infection, discomfort or other outcome detrimental to a patient's course of recovery." The policy states "construction, demolition, or repair projects may impact the environment and health of staff, physicians, visitors, and patients. This impact may be creating and releasing airborne particles, disrupting power or medical gases, loss of sewage containment." The procedure states "on an as needed basis plant operations will notify the standing participants involved in all assessments of upcoming projects. Standing participants are Infection Control Director, Director of Risk Management, and Safety Officer."

The Construction and Infection Control Risk Assessment policy defines a Type C project as "any activity which cannot be completed within a single work shift" and the patient risk group as "high risk" based upon it being a medical unit. This would make the project a Class III/IV project. The policy states an "ICRA permit signed by all of the standing participants is required" and "during off-hours a telephone consult with infection control may suffice until a formal discussion can be held."

On 7/2/15 at 10:55 a.m., the CQO confirmed the policy was not followed and an ICRA should have been completed. She said if the scope of the issue was property identified during the Environment of Care meeting on 5/28/15, they could have an "emergency meeting" with the governing board to make them aware of the issues within the facility. She stated "this was not done since the facility was unaware of the scope of the issue."

13. Review of the Board of Trustees minutes dated 6/10/15 confirmed the issues related to the sewage leak was not brought up to the governing body. The Risk Manager said only patient safety was discussed and it was not the Environment of Care's turn to discuss issues with the governing body at this meeting.
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Based on observations at the facility, interviews, and review of administrative records and policy and procedures, the facility failed to ensure the safety of the patients by not providing a safe and sanitary environment for diagnosis and treatment of patients.

On 5/26/15 a 6-inch sewage line draining the entire 3rd and 4th floors broke. The sewage water leaked into the interstitial space above the 2nd floor, down the walls by the elevators, and flowed down an elevator shaft. A restoration company was called in to clean up the spill. However, the interstitial space was not properly cleaned up. Based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak. An Infection Control Risk Assessment (ICRA) was never completed. The facility failed to maintain a safe and sanitary physical environment by not properly addressing or remediating the sewage spill from 5/26/15 until 6/29/15 (refer to A701 and A724). The facility failed to ensure the infection control program was aware of the sewage leak from 5/26/15 until 6/29/15 or of a rodent problem from 6/30/15 until 7/1/15 (refer to A747 and A749). The cumulative effect of these systemic problems resulted in the hospital's failure to maintain a safe and sanitary environment.
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Based on observations at the facility, interviews, and review of administrative records and policy and procedures, the facility failed to ensure the hospital environment was maintained to assure the safety and well-being of patients. The facility failed to adequately address a large sewage spill within the hospital.

The findings included:

1. In an interview on 6/29/15, the Director of Plant Operations (DPO) said on 5/26/15 the facility had a sewage leak in the interstitial space above the 2nd floor nursing unit called 2 North. The 2 North unit is a post-surgical orthopedic nursing unit. The interstitial space between the 2nd and 3rd floors was the old building roof before the 3rd and 4th floors were added. The old roof was made of gravel, tar, and particle board layers.

The DPO said this sewage leak was identified by the facility nursing staff on 5/26/15 at approximately 12:30 p.m., when water was leaking from the ceiling and running down several walls of the 2 North, Team 3 nursing unit. The staff visibly identified 3 areas: in the hallway across from patient room #275 and both sides of the hallway by the elevators directly in front of the nursing station. The sewage water leaked down the walls by the elevators and flowed down the 2 North elevator shaft. This caused the elevator electrical to short out. The DPO stated the "sewage water was flowing at a steady pace and required large trash bins to capture the water."

On 6/29/15 at 6:30 p.m., the 2 North Unit Manager said she was present when the sewage leak occurred. She said the water leaked down the walls. The fire doors were closed to contain part of the leak. She said blankets were used to control the water and guide it down the elevator. Water was observed throughout the unit's ceiling tiles and staff was keeping an eye on the lighting fixtures which were filling with water. The unit secretary confirmed this.

2. In an interview on 6/29/15, the DPO said his team immediately went up to the interstitial space and identified the leak was from the 6-inch main sewage line draining the entire 3rd and 4th floors. His team placed a cap on the sewage line to stop the leak. He said they identified the sewage leak was caused by facility staff flushing sanitary wipes, which caused the pipe to burst.

The DPO said he called in an environmental restoration company who arrived on 5/26/15 at approximately 2:00 p.m. to clean up the sewage leak. He stated their job was to "extract, dry up, and clean up any affected areas" in the interstitial space, on the 2nd floor nursing unit, and in the 1st floor back kitchen office. The DPO said when the restoration company came, they placed a visqueen wall "somewhere in the middle of the 2 North Team 3 nursing unit hallway" and in the "back office of the kitchen area." They proceeded to clean up the sewage leak and dry the affected areas. He said the restoration company was in the facility for 5 days and left on 5/30/15. He stated "at no time during the restoration project and cleanup were patients moved." The unit remained open to all patients on the unit and included the physical therapy gym.

3. On 6/29/15, observations during a tour of the interstitial space with the DPO found the interstitial space was not properly cleaned up by the restoration company. There was a sewage odor, sanitary wipes and toilet paper were visible, and the floor was still wet. The DPO acknowledged the restoration company should have done a better job cleaning up the interstitial space. The DPO confirmed the raw sewage spill traveled over 80 feet from where the pipe burst to where the elevator shaft was. This 80 foot distance spans almost the entire 2 North, Team 3 nursing unit ceiling. On the 2 North nursing unit, there was still a discoloration observed from the sewage spill on the walls by the elevators.

On 6/29/15 at 12:50 p.m., the DPO said the restoration company told him the problem was fixed, and he did not notice any issues. He said the restoration company did not make further recommendations. He stated "they did no environmental testing within the hospital related to the sewage spill to determine the extent of the problem." An Infection Control Risk Assessment (ICRA) was not completed. The DPO said normally the restoration company does both the environmental testing and the ICRA.

On 7/2/15 at 9:30 a.m., the DPO said the restoration company gave him "no concerns" and stated "there is no reason why the ICRA was not done." He confirmed the restoration company normally does them for him and he just signs off on them.

4. On 6/30/15 at 11:10 a.m., a tour of the interstitial space with the Industrial Hygienist (IH) confirmed, based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak on 5/26/15. The industrial hygienist said he will be taking more core samples to determine the extent of the affected areas and create a map of the areas which still need remediation.

5. On 6/30/15 at 4:30 p.m. on a tour of the back kitchen office with the DPO, noises were heard coming from the ceiling tiles and 4 live rodents (rats) were observed above the ceiling tiles. The DPO said he would have pest control come out immediately and evaluate the problem.

6. On 7/1/15 at 2:00 p.m., the Risk Manager stated "no one was aware of the scope [of the sewage leak] until this week." She said she was aware the restoration company was in the building, but "at no time did I think I needed to check on the progress of the project."
She said she was not aware of any issues with rodents in the facility at this time and confirmed she has not had a report from the DPO about any issues with rodents on the 6/30/15 tour. The Risk Manager said routine pest prevention service is completed and confirmed the facility does not have a pest control policy or contract in place.

7. On 7/2/15 at 8:15 a.m., the COO confirmed she oversees plant operations and stated she "knew of the leak when it happened but as far as she was aware, it was under control." She thought the elevator being closed was the bigger concern. She was not aware the sewage spill was from a main line and went over 80 feet. She said over the past 2 days, the facility was "now aware of the breadth of the situation." She said as of this week, the unit and elevators will remain closed until the environmental testing can be completed. She confirmed she did not involve the Infection Control Director when the decision was made to close the unit on 6/29/15 and she did not talk to the Infection Control Director until earlier this morning to discuss all the issues identified. She said the facility has caught 3 of the 4 rodents observed and is working on a long-term pest control plan.

8. On 7/1/15 at 4:20 p.m., the Chief Executive Officer (CEO) stated "we did not know the scope of the issue." He stated the facility "thought we did the right thing and fixed it, but trusted the restoration company too much." He said they did not have any contract in place with the restoration company. He stated the facility "should know when the visqueen wall goes up they will need to have industrial health testing." He said with the Director of Infection Control being out on vacation, the ICRA report was not completed and confirmed the infection control risk for the facility was unknown.

9. On 7/1/15 at 4:45 p.m., the Director of Infection Control confirmed she was on vacation during the incident. She said she came back on 7/1/15 and never had a meeting to discuss any issues that occurred while she was gone. She said on approximately 7/7/15 she observed the elevators were closed. Staff told her the "plumbing overflowed and shorted out the elevator."

10. On 7/2/15 at 9:30 a.m., the Risk Manager said this issue was discussed in the daily huddle on 5/27/15, and also the environment of care meeting on 5/28/15, but added the focus was on the cause of the leak and the elevators being shut down. She stated "no one thought to determine if the cleanup was handled correctly."

The "safety huddle sign in sheet" dated 5/27/15 documents the CEO, ACEO, Chief Quality Officer (CQO), RM, DPO, and the Director of Dietary were all present during the meeting. Review of the "daily safety huddle record" revealed the leak was discussed and "plant ops staff were recognized for responding to the major leak so quickly."

The Environment of Care Committee reports to the governing board. Review of the Environment of Care Committee minutes dated 5/28/15 revealed "we had a sewer pipe leak due to wipes being flushed down toilets. North Elevators have been shut down for repair due to this leak."

11. Review of the facility's Construction and Infection Control Risk Assessment policy (number IC-16-01, last reviewed 1/15) revealed the purpose was "once implemented, should minimize the risk of infection, discomfort or other outcome detrimental to a patient's course of recovery." The policy states "construction, demolition, or repair projects may impact the environment and health of staff, physicians, visitors, and patients. This impact may be creating and releasing airborne particles, disrupting power or medical gases, loss of sewage containment." The procedure states "on an as needed basis plant operations will notify the standing participants involved in all assessments of upcoming projects. Standing participants are Infection Control Director, Director of Risk Management, and the Safety Officer." It goes on to say "the daily administrative huddle ... may be an appropriate forum for this weekly notification."

The Construction and Infection Control Risk Assessment policy defines a Type C project as "any activity which cannot be completed within a single work shift" and the patient risk group as "high risk" based upon it being a medical unit. This would make the project a Class III/IV project. The policy states an "ICRA permit signed by all of the standing participants is required" and "during off-hours a telephone consult with infection control may suffice until a formal discussion can be held."

On 7/2/15 at 10:55 a.m., the CQO confirmed the policy was not followed and an ICRA should have been completed. She said if the scope of the issue was properly identified during the Environment of Care meeting on 5/28/15, they could have had an "emergency meeting" with the governing board to make them aware of the issues within the facility. She stated "this was not done since the facility was unaware of the scope of the issue."
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Based on observations at the facility, interviews, and review of administrative records and policy and procedures, the facility failed to evaluate the safety and effectiveness of maintenance activities for the facility and take corrective actions to assure the safety and well-being of patients. The facility failed to adequately address a large sewage spill within the hospital.

The findings included:

1. In an interview on 6/29/15, the Director of Plant Operations (DPO) said on 5/26/15 the facility had a sewage leak in the interstitial space above the 2nd floor nursing unit called 2 North. The 2 North unit is a post-surgical orthopedic nursing unit. The interstitial space between the 2nd and 3rd floors was the old building roof before the 3rd and 4th floors were added. The old roof was made of gravel, tar, and particle board layers.

The DPO said this sewage leak was identified by the facility nursing staff on 5/26/15 at approximately 12:30 p.m. when water was leaking from the ceiling and running down several walls of the 2 North, Team 3 nursing unit. The staff visibly identified 3 areas: in the hallway across from patient room #275 and both sides of the hallway by the elevators directly in front of the nursing station. The sewage water leaked down the walls by the elevators and flowed down the 2 North elevator shaft. This caused the elevator electrical to short out. The DPO stated the "sewage water was flowing at a steady pace and required large trash bins to capture the water."

On 6/29/15 at 6:30 p.m., the 2 North Unit Manager said she was present when the sewage leak occurred. She said the water leaked down the walls. The fire doors were closed to contain part of the leak. She said blankets were used to control the water and guide it down the elevator. Water was observed throughout the unit's ceiling tiles and staff was keeping an eye on the lighting fixtures which were filling with water. The unit secretary confirmed this.

2. In an interview on 6/29/15, the DPO said his team immediately went up to the interstitial space and identified the leak was from the 6-inch main sewage line draining the entire 3rd and 4th floors. His team placed a cap on the sewage line to stop the leak. He said they identified the sewage leak was caused by facility staff flushing sanitary wipes, which caused the pipe to burst.

The DPO said he called in an environmental restoration company who arrived on 5/26/15 at approximately 2:00 p.m. to clean up the sewage leak. He stated their job was to "extract, dry up, and clean up any affected areas" in the interstitial space, on the 2nd floor nursing unit, and in the 1st floor back kitchen office. The DPO said when the restoration company came, they placed a visqueen wall "somewhere in the middle of the 2 North Team 3 nursing unit hallway" and in the "back office of the kitchen area." They proceeded to clean up the sewage leak and dry the affected areas. He said the restoration company was in the facility for 5 days and left on 5/30/15. He stated "at no time during the restoration project and cleanup were patients moved." The unit remained open to all patients on the unit and included the physical therapy gym.

3. On 6/29/15, observations during a tour of the interstitial space with the DPO found the interstitial space was not properly cleaned up by the restoration company. There was a sewage odor, sanitary wipes and toilet paper were visible, and the floor was still wet. The DPO acknowledged the restoration company should have done a better job cleaning up the interstitial space. The DPO confirmed the raw sewage spill traveled over 80 feet from where the pipe burst to where the elevator shaft was. This 80 foot distance spans almost the entire 2 North, Team 3 nursing unit ceiling. On the 2 North nursing unit, there was still a discoloration observed from the sewage spill on the walls by the elevators.

On 6/29/15 at 12:50 p.m., the DPO said the restoration company told him the problem was fixed, and he did not notice any issues. He said the restoration company did not make further recommendations. He stated "they did no environmental testing within the hospital related to the sewage spill to determine the extent of the problem." An Infection Control Risk Assessment (ICRA) was not completed. The DPO said normally the restoration company does both the environmental testing and the ICRA.

On 7/2/15 at 9:30 a.m., the DPO said he was not sure why the visqueen wall was not put up by the elevators. He said he thought since the sewage water was cleaned up quickly, they did not put up any walls on the end of the unit. He said the restoration company gave him "no concerns" and stated "there is no reason why the ICRA was not done." He confirmed the restoration company normally does them for him and he just signs off on them.

4. On 6/30/15 at 11:10 a.m., a tour of the interstitial space with the Industrial Hygienist (IH) confirmed, based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak on 5/26/15. The industrial hygienist said he will be taking more core samples to determine the extent of the affected areas and create a map of the areas which still need remediation.

5. On 6/30/15 at 4:30 p.m., on a tour of the back kitchen office with the DPO, noises were heard coming from the ceiling tiles and 4 live rodents (rats) were observed above the ceiling tiles. The DPO said he would have pest control come out immediately and evaluate the problem.

6. On 7/1/15 at 2:00 p.m., the Risk Manager stated "no one was aware of the scope [of the sewage leak] until this week." She said she was aware the restoration company was in the building, but "at no time did I think I needed to check on the progress of the project."
She said she was not aware of any issues with rodents in the facility at this time and confirmed she has not had a report from the DPO about any issues with rodents on the 6/30/15 tour. The Risk Manager confirmed the facility does not have a pest control policy or contract in place.

7. On 7/1/15 at 3:15 p.m., the COO said she was told about the leak by the DPO when the event occurred and the restoration company was in the building. She stated "she was not aware of the scope of events when this happened and thought the issue was handled." She added their focus on the sewage leak was to prevent the leak from occurring again by educating the facility staff to not flush the sanitary wipes. They thought the restoration company was doing their job. She confirms there was no ICRA completed by staff when the visqueen wall went up since no one really understood the scope of the problem.

On 7/2/15 at 8:15 a.m., the COO confirmed she oversees plant operations and stated she "knew of the leak when it happened but as far as she was aware, it was under control." She thought the elevator being closed was the bigger concern. She was not aware the sewage spill was from a main line and went over 80 feet. She said over the past 2 days, the facility was "now aware of the breadth of the situation." She said as of this week (6 weeks after the spill), the unit and elevators will remain closed until the environmental testing can be completed. She confirmed she did not involve the Infection Control Director when the decision was made to close the unit on 6/29/15 and she did not talk to the Infection Control Director until earlier this morning to discuss all the issues identified. She said the facility has caught 3 of the 4 rodents observed and is working on a long-term pest control plan.

8. On 7/1/15 at 4:20 p.m., the Chief Executive Officer (CEO) stated "we did not know the scope of the issue." He stated the facility "thought we did the right thing and fixed it, but trusted the restoration company too much." He said they did not have any contract in place with the restoration company. He stated the facility "should know when the visqueen wall goes up they will need to have industrial health testing."

9. On 7/1/15 at 4:45 p.m., the Director of Infection Control confirmed she was on vacation during the incident. She said she came back on 7/1/15 and never had a meeting to discuss any issues that occurred while she was gone. She said on approximately 7/7/15 she observed the elevators were closed. Staff told her the "plumbing overflowed and shorted out the elevator."

10. On 7/2/15 at 9:30 a.m., the Risk Manager said this issue was discussed in the daily huddle on 5/27/15, and also the Environment of Care meeting on 5/28/15, but added the focus was on the cause of the leak and the elevators being shut down. She stated "no one thought to determine if the cleanup was handled correctly."

The "safety huddle sign in sheet" dated 5/27/15 documents the CEO, ACEO, Chief Quality Officer (CQO), RM, DPO, and the Director of Dietary were all present during the meeting. Review of the "daily safety huddle record", revealed the leak was discussed and "plant ops staff were recognized for responding to the major leak so quickly."

The Environment of Care Committee reports to the governing board. Review of the Environment of Care Committee minutes dated 5/28/15 revealed "we had a sewer pipe leak due to wipes being flushed down toilets. North Elevators have been shut down for repair due to this leak."

11. On 7/2/15 at 10:55 a.m., the CQO said "no one was thinking there was any patient safety issues at this time." She stated "we all just dropped the ball and did not know the extent of the issue." She said both the DPO and the Director of Infection Control should work closely with any restoration projects, and this was not done.

12. Review of the facility's Construction and Infection Control Risk Assessment policy (number IC-16-01, last reviewed 1/15) revealed the purpose was "once implemented, should minimize the risk of infection, discomfort or other outcome detrimental to a patient's course of recovery." The policy states "construction, demolition, or repair projects may impact the environment and health of staff, physicians, visitors, and patients. This impact may be creating and releasing airborne particles, disrupting power or medical gases, loss of sewage containment." The procedure states "on an as needed basis plant operations will notify the standing participants involved in all assessments of upcoming projects. Standing participants are Infection Control Director, Director of Risk Management, and the Safety Officer." It goes on to say "the daily administrative huddle ... may be an appropriate forum for this weekly notification."

The Construction and Infection Control Risk Assessment policy defines a Type C project as "any activity which cannot be completed within a single work shift" and the patient risk group as "high risk" based upon it being a medical unit. This would make the project a Class III/IV project. The policy states an "ICRA permit signed by all of the standing participants is required" and "during off-hours a telephone consult with infection control may suffice until a formal discussion can be held."

On 7/2/15 at 10:55 a.m., the CQO confirmed the policy was not followed and an ICRA should have been completed. She said if the scope of the issue was properly identified during the Environment of Care meeting on 5/28/15, they could have had an "emergency meeting" with the governing board to make them aware of the issues within the facility. She stated "this was not done since the facility was unaware of the scope of the issue."
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Based on observations at the facility, interviews, review of administrative records, policy and procedures, and other documentation, the facility failed to ensure the infection control program was comprehensive, hospital-wide, or effective. The Infection Control Officer was largely unaware of the extent of the large sewage leak within the facility on 5/26/15 until survey inquiry on 6/29/15. The Infection Control Officer was also unaware of rodents sighted on 6/30/15 until 7/1/15.

On 5/26/15 a 6-inch sewage line draining the entire 3rd and 4th floors broke. The sewage water leaked into the interstitial space above the 2nd floor, down the walls by the elevators, and flowed down an elevator shaft. A restoration company was called in to clean up the spill. However, the interstitial space was not properly cleaned up. Based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak. An Infection Control Risk Assessment (ICRA) was never completed. The facility failed to maintain a safe and sanitary environment by not properly addressing or remediating the sewage spill from 5/26/15 until 6/29/15 (refer to A749). The facility failed to ensure the infection control program was aware of the sewage leak from 5/26/15 until 6/29/15 or of a rodent problem from 6/30/15 until 7/1/15 (refer to A749). The cumulative effect of these systemic problems resulted in the hospital's failure to maintain a safe and sanitary environment.
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Based on observations at the facility, interviews, review of administrative records, policy and procedures, infection control, and quality assurance documentation, the facility failed to ensure the infection control program was comprehensive, hospital-wide, or effective. The Infection Control Officer was largely unaware of the extent of the large sewage leak within the facility on 5/26/15 until survey inquiry on 6/29/15. The Infection Control Officer was also unaware of rodents sighted on 6/30/15 until 7/1/15.

The findings included:

1. In an interview on 6/29/15, the Director of Plant Operations (DPO) said on 5/26/15 the facility had a sewage leak in the interstitial space above the 2nd floor nursing unit called 2 North. The 2 North unit is a post-surgical orthopedic nursing unit. The interstitial space between the 2nd and 3rd floors was the old building roof before the 3rd and 4th floors were added. The old roof was made of gravel, tar, and particle board layers.

The DPO said this sewage leak was identified by the facility nursing staff on 5/26/15 at approximately 12:30 p.m., when water was leaking from the ceiling and running down several walls of the 2 North, Team 3 nursing unit. The staff visibly identified 3 areas: in the hallway across from patient room #275 and both sides of the hallway by the elevators directly in front of the nursing station. The sewage water leaked down the walls by the elevators and flowed down the 2 North elevator shaft. This caused the elevator electrical to short out. The DPO stated the "sewage water was flowing at a steady pace and required large trash bins to capture the water."

On 6/29/15 at 6:30 p.m., the 2 North Unit Manager said she was present when the sewage leak occurred. She said the water leaked down the walls. The fire doors were closed to contain part of the leak. She said blankets were used to control the water and guide it down the elevator. Water was observed throughout the unit's ceiling tiles and staff was keeping an eye on the lighting fixtures which were filling with water. The unit secretary confirmed this.

2. In an interview on 6/29/15, the DPO said his team placed a cap on the sewage line to stop the leak and called in an environmental restoration company to clean up. He stated their job was to "extract, dry up, and clean up any affected areas" in the interstitial space, on the 2nd floor nursing unit, and in the 1st floor back kitchen office. The DPO said when the restoration company came, they placed a visqueen wall "somewhere in the middle of the 2 North Team 3 nursing unit hallway" and in the "back office of the kitchen area." They proceeded to clean up the sewage leak and dry the affected areas. He said the restoration company was in the facility for 5 days and left on 5/30/15. He stated "at no time during the restoration project and cleanup were patients moved." The unit remained open to all patients on the unit and included the physical therapy gym.

3. On 6/29/15, observations during a tour of the interstitial space with the DPO found the interstitial space was not properly cleaned up by the restoration company. There was a sewage odor, sanitary wipes and toilet paper were visible, and the floor was still wet. The DPO acknowledged the restoration company should have done a better job cleaning up the interstitial space. The DPO confirmed the raw sewage spill traveled over 80 feet from where the pipe burst to where the elevator shaft was. This 80 foot distance spans almost the entire 2 North, Team 3 nursing unit ceiling. On the 2 North nursing unit, there was still a discoloration observed from the sewage spill on the walls by the elevators.

On 6/29/15 at 12:50 p.m., the DPO said the restoration company "did no environmental testing within the hospital related to the sewage spill to determine the extent of the problem." An Infection Control Risk Assessment (ICRA) was not completed. The DPO said normally the restoration company does both the environmental testing and the ICRA.

4. In an interview on 6/29/15 at 1:00 p.m., the Risk Manager (RM) said the ICRA was not completed and the Infection Control Nurse was not involved in the process since she was on vacation.

5. On 6/30/15 at 11:10 a.m., a tour of the interstitial space with the Industrial Hygienist (IH) confirmed, based on core drilling samples, the particle board floor of the interstitial unit was still wet 36 days after the sewage leak on 5/26/15. The industrial hygienist said he will be taking more core samples to determine the extent of the affected areas and create a map of the areas which still need remediation.

6. On 6/30/15 at 4:30 p.m., on a tour of the back kitchen office with the DPO, noises were heard coming from the ceiling tiles and 4 live rodents (rats) were observed above the ceiling tiles. The DPO said he would have pest control come out immediately and evaluate the problem.

7. On 7/1/15 at 2:00 p.m., the Risk Manager stated "no one was aware of the scope [of the sewage leak] until this week." She confirmed the facility does not have a pest control policy or contract in place.

8. On 7/2/15 at 8:15 a.m., the COO confirmed she oversees plant operations and stated she "knew of the leak when it happened but as far as she was aware, it was under control." She thought the elevator being closed was the bigger concern. She was not aware the sewage spill was from a main line and went over 80 feet. She said over the past 2 days, the facility was "now aware of the breadth of the situation." She said as of this week, the unit and elevators will remain closed until the environmental testing can be completed. She confirmed she did not involve the Infection Control Director when the decision was made to close the unit on 6/29/15 and she did not talk to the Infection Control Director until earlier this morning to discuss all the issues identified. She said the facility has caught 3 of the 4 rodents observed and is working on a long-term pest control plan.

9. On 7/1/15 at 4:20 p.m., the Chief Executive Officer (CEO) said with the Director of Infection Control being out on vacation and the ICRA report was not completed, he confirmed the infection control risk for the facility was unknown.

10. On 7/1/15 at 4:45 p.m., the Director of Infection Control confirmed she was on vacation during the incident. She said she came back on 7/1/15 and never had a meeting to discuss any issues that occurred while she was gone. She said on approximately 7/7/15 she observed the elevators were closed. Staff told her the "plumbing overflowed and shorted out the elevator." She said she was not even aware the restoration company came into the facility until today. She said her backup left early on 5/26/15 and was never notified about the restoration company either. She confirmed she "was not kept in the loop" when patients were removed from the unit on 6/29/15. She stated she "has not been involved in any infection control projects related to the spill all week." She said she was not aware an industrial hygienist was in the building doing testing this week. She also confirmed she was not even aware a visqueen wall was set up in the kitchen. She said any time a visqueen wall needs to go up, the infection control department should be involved to do the ICRA. She confirmed they were not involved at any point from when the spill occurred on 5/29/15 through 7/1/15. She stated "no one knew the scope of the issue until today." She said she was not aware of any issues with rodents in the facility at this time and confirmed that she has not had a report from the DPO about any rodents seen on the 6/30/15 tour.

11. On 7/2/15 at 9:30 a.m., the Risk Manager stated "no one ever thought to get infection control involved since no one was aware of the scope of the issue." She said this issue was discussed in the daily huddle on 5/27/15, and also the Environment of Care meeting on 5/28/15, but added the focus was on the cause of the leak and the elevators being shut down. She stated "no one thought to determine if the cleanup was handled correctly."

The "safety huddle sign in sheet" dated 5/27/15 documents the CEO, ACEO, Chief Quality Officer (CQO), RM, DPO, and the Director of Dietary were all present during the meeting. Review of the "daily safety huddle record" revealed the leak was discussed and "plant ops staff were recognized for responding to the major leak so quickly."

The Environment of Care Committee reports to the governing board. Review of the Environment of Care Committee minutes dated 5/28/15 revealed "we had a sewer pipe leak due to wipes being flushed down toilets. North Elevators have been shut down for repair due to this leak."

12. On 7/2/15 at 10:55 a.m., the CQO confirmed she oversees the infection control department. She said she was not made aware of the issue until the safety huddle on 5/27/15. She stated "the concern was to prevent the issue from re-occurring" and "the facility did not consider this an infection control issue." She stated "no one was thinking there was any patient safety issues at this time." She stated "we all just dropped the ball and did not know the extent of the issue." She said both the DPO and the Director of Infection Control should work closely with any restoration projects, and this was not done.

13. Review of the facility's Construction and Infection Control Risk Assessment policy (number IC-16-01, last reviewed 1/15) revealed the purpose was "once implemented, should minimize the risk of infection, discomfort or other outcome detrimental to a patient's course of recovery." The policy states "construction, demolition, or repair projects may impact the environment and health of staff, physicians, visitors, and patients. This impact may be creating and releasing airborne particles, disrupting power or medical gases, loss of sewage containment." The procedure states "on an as needed basis plant operations will notify the standing participants involved in all assessments of upcoming projects. Standing participants are Infection Control Director, Director of Risk Management, and the Safety Officer." It goes on to say "the daily administrative huddle ... may be an appropriate forum for this weekly notification. "

The Construction and Infection Control Risk Assessment policy defines a Type C project as "any activity which cannot be completed within a single work shift" and the patient risk group as "high risk" based upon it being a medical unit. This would make the project a Class III/IV project. The policy states an "ICRA permit signed by all of the standing participants is required" and "during off-hours a telephone consult with infection control may suffice until a formal discussion can be held."

On 7/2/15 at 10:55 a.m., the CQO confirmed the policy was not followed and an ICRA should have been completed. She said if the scope of the issue was properly identified during the Environment of Care meeting on 5/28/15, they could have had an "emergency meeting" with the governing board to make them aware of the issues within the facility. She stated "this was not done since the facility was unaware of the scope of the issue."
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