HospitalInspections.org

A. Based on observation, documentation review, and staff interviews, it was determined that staff failed to ensure the hospital was maintained in a manner to ensure patient safety and quality of care as evidenced by recurring sewage leaks in operating rooms (OR); potentially exposing patients to microbial contamination of the sterile environment during operative procedures; seven (7) sewage leaks occurred over an 11-month period between September 2016 and August 2017 wherein seven (7) of 11 patients underwent surgical procedures in the OR during or proximal to the occurrences of water/sewage intrusion. (Patients #1, 4, 5, 6, 7, 8, 9, 10, and 11).

An Immediate Jeopardy (IJ) was identified at 42 CFR 482.12 (b ) Facilities must be maintained to ensure an acceptable level of safety and quality. Failure to provide safety from environmental hazards and waste. The notification of the IJ was made on Friday, August 18, 2017 at 5:45 PM.

The facility's Leadership provided a letter noting a corrective action plan on Friday, August 18, 2017 at 7:30 PM. The IJ was removed on August 21, 2017.

The findings include:

A review of the facility's occurrence reports, and maintenance work orders revealed sewage leaks occurred on seven (7) occasions in the OR as follows: September 30, 2016, March 27, 2017, July 5, 2017, July 11, 2017, July 17, 2017 and July 19, 2017. On August 17, 2017 at approximately 10:45 AM, during the onsite investigation, the survey team observed an active leak in OR Pod #2.

The observation is detailed as follows:


On August 18, 2017 at approximately 10:45 AM, the surveyors conducted a tour of the Medstar Washington Hospital Center Main Operating Room in the presence of Employees #3, 7, 8, 10, 11, 12, and 13. During the tour, a black, grainy, foul smelling substance was observed on the floor of room G-139, located in Pod #2. Pod #2 houses Operating rooms 7-12. The Operating rooms (7-12) are designated for General Trauma, Orthopedic Trauma, Bariatric surgery, Gynecological surgery, and Spinal Sugery. Employee #10 explained that s/he had just been notified that there was a sewage leak in that room. S/he went on to explain that this is the 3rd time that a leak of that sort occurred in room G-139. G-139 is known as a "Sub-Sterile room" and is located between OR's (Operating Room) 7 and 8. The room houses the back of a decommissioned autoclave, per Employee #10, 11, and 13 the leaks were coming from the drain in the floor under the autoclave.


Review of "Theradoc (a microbiology based system used by the infection control department)" documentation presented to the surveyors July 17, 2017 at approximately 3:00 PM on September 30, 2016 at 10:35 AM revealed, "Patient in OR 7 during leak in room G-139. Patient #5 was undergoing a Tumor Resection of the Right Wrist at the time. Review of a leak remediation report dated March 27, 2017 revealed that on March 23, 2017 there was " ...water loss which occurred in room G-139. The source of the loss was a drain located underneath the decommissioned autoclave ..."


On July 17, 2017 at approximately 12:30 PM the surveyors conducted a review of requested "Work Orders" related to water intrusion in the Operating rooms. The work orders revealed five (5) separate events of water intrusion. In the Third Floor Operating Room #4 there were ceiling leaks on July 5, 7, and 11, 2017. Review of "Theradoc" documentation dated July 5, 2017 at 11:49 AM revealed that on that day, " a flood from above occurred in the operating room". At that time Patient #1 was undergoing a laparoscopic procedure. "Theradoc" documentation dated July 11, 2017 at 3:15 PM revealed that on that day " ...During the surgery a flood occurred from above through the ceiling light fixture ..." Patient #4 was undergoing a laparoscopic procedure at the time of the leak.


On July 17 and 19, 2017 there were "black water" leaks from the wall in Main OR #11 located in Pod 2. Review of the Main OR schedule from July 17, 2017 revealed that Patient #5 was in OR #11 at the time the leak was identified. Review of "Theradoc" documentation dated July 20, 2017 at 11:26 AM revealed that on July 19, 2017 "patient was in OR 11 and draped ...when a leak occurred which resulted in sewage draining from the wall ...". Patient #11 was scheduled in the OR for a Debridement of the Abdominal Wall.


A face to face interview was conducted on August 17, 2017 at approximately 1:45 PM with Employees #3, 4, 5, 6, and 10, regarding the leaks in the operating rooms, and the definition of "black water". Employee #5 explained that "black water" describes sewage, and the that leaks that occurred in OR #4 on the third floor, and OR 11 in the Main OR were sewage leaks. S/he went on to say that the cause of the leaks in the Third Floor OR #4 were related to a clogged toilet in the Cardiac Catheterization Lab located above the OR #4. The cause for the leaks in OR #11 were related to a dialysis box that has a water source and is no longer in use in the OR.


When queried about the source of the recurring leaks in room G-139, Employee #5 stated that the cause of the leaks appeared to be "wipes" used by staff, for patient care being, flushed down the toilets causing a drain back up. When asked about the remediation process for the leaks, Employee #10 explained that when there is a leak, infection control comes up with the Infection Control Risk Assessment (ICRA), the industrial hygiene company and comes up with a remediation plan that is then shared with the contracted remediation and restoration construction company, who performs the physical remediation. Once the remediation is complete, the industrial hygiene company gives the all clear, a terminal clean of the room is completed, and the room is re-opened for use.


On August 18, 2017 at approximately 10:00 AM a review of the "Remediation Scope of Work" and summaries of the post-remediation validation assessment, was conducted. These reports are provided to the hospital by the industrial hygiene company. The facility was able to provide reports from all dates with the exception of the July 17, 2017 leak, that occurred in OR #11.


A face to face interview was conducted on August 18, 2017 at approximately 3:50 PM with Employee's #6 and 10, and Contractors #1 and 2 regarding the July17, 2017 leak in OR #11. Employee #6 and 10 stated that they were not made aware of a leak in OR #11 on July 17, 2017. Contractors #1 and 2 both stated that they were not made aware of any leaks on July17, 2017 in OR #11. Contractor #1 stated that the only call they got was with regard to a leak on July 19, 2017. Contractor #1 was able to provide a remediation report for that occurrence.


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10, regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 the maintenance department received a call about a leak from a dialysis box in OR #11. The maintenance staff gained access to the drain by cutting the drywall in the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service.


Review of the Main Operating Room schedule from July 17 through 19, 2017 revealed that on July 18, 2017, Patients #6, 7, and 8 had procedures in OR #11. A work order dated July 19, 2017 at 8:53 AM revealed that there was once again a complaint of "water coming from the wall" in OR #11 while Patient #9 was undergoing a procedure. The contracted industrial hygiene company provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR#11. " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR 11 and room G155 is suspected to be wet ..."


The surveyors conducted a telephone interview with Employee #18, on August 18, 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10 regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 they got a call about a leak from a dialysis box in OR #11. The maintenance crew gained access to the drain by cutting the drywall the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service. Both employees acknowledged that the full remediation process did not take place for the leak that occurred on July 17, 2017. OR#11 was returned to service in less than 24 hours.

On August 18, 2017 at approximately 4:30 PM, the surveyor reviewed the Main Operating Room schedule, from July 17 through 19, 2017, which revealed Patients #6, 7, and 8 had procedures in OR #11, on July 18, 2017. A work order, dated July 19, 2017 at 8:53 AM, revealed that there was another complaint of "water coming from the wall" in OR #11, this time, while Patient #9 was undergoing a procedure. The contracted, Industrial Hygiene Company, provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR #11. The documentation revealed, " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR #11 and room G155 is suspected to be wet ..."

The hospital failed ensure that patients received care in a safe setting, by continuing to provide services in Operating Rooms, specifically in Pod 2, that repeatedly had multiple sewage leaks, of which five (5) occurrences happened recently, during the month of July 2017.

A review of infection control records, surgical site infection reports and a review of the facility's reporting of healthcare acquired infections, lacked evidence that patients sustained untoward effects or infections as a direct result of the sewage intrusion in the OR.

A face to face interview was conducted on August 18, 2017 at approximately 6:00 PM with Employees #1, 2, 3, 4, 5, 7, 10, 13, and 19. The acknowledged the findings.


B. Based on document review and staff interview, it was determined that the Governing Body failed to maintain quality standards of patient care, as evidenced by failure to develop a policy, with standard procedures to govern the prevention of recurrent water/sewage intrusion in the Operating Room.


The findings include:


On August 18, 2017 at approximately 10:45 AM, the surveyors conducted a tour of the Medstar Washington Hospital Center Main Operating Room in the presence of Employees #3, 7, 8, 10, 11, 12, and 13. During the tour ,a black, grainy, foul smelling substance was observed on the floor of room G-139, located in Pod #2. Pod #2 houses Operating rooms 7-12. The Operating rooms are designated for General Trauma, Orthopedic Trauma, Bariatric surgery, Gynecological surgery, and Spinal Sugery. Employee #10 explained that s/he had just been notified that there was a sewage leak in that room. S/he went on to explain that this is the 3rd time that a leak of that sort occurred in room G-139. G-139 is known as a "Sub-Sterile room" and is located between OR's (Operating Room) 7 and 8. The room houses the back of a decommissioned autoclave, per Employee #10, 11, and 13 the leaks were coming from the drain in the floor under the autoclave.


Review of "Theradoc (a microbiology based system used by the infection control department)" documentation presented to the surveyors July 17, 2017 at approximately 3:00 PM on September 30, 2016 at 10:35 AM revealed, "Patient in OR 7 during leak in room G-139. Patient #5 was undergoing a Tumor Resection of the Right Wrist at the time. Review of a leak remediation report dated March 27, 2017 revealed that on March 23, 2017 there was " ...water loss which occurred in room G-139. The source of the loss was a drain located underneath the decommissioned autoclave ..."


On August 17, 2017 at approximately 12:30 PM the surveyors conducted a review of requested "Work Orders" related to water intrusion in the Operating rooms. The work orders revealed five (5) separate events of water intrusion. In the Third Floor Operating Room #4 there were ceiling leaks on July 5, 7, and 11, 2017. Review of "Theradoc" documentation dated July 5, 2017 at 11:49 AM revealed that on that day, " a flood from above occurred in the operating room". At that time Patient #1 was undergoing a laparoscopic procedure. "Theradoc" documentation dated July 11, 2017 at 3:15 PM revealed that on that day " ...During the surgery a flood occurred from above through the ceiling light fixture ..." Patient #4 was undergoing a laparoscopic procedure at the time of the leak.


On July 17 and 19, 2017 there were "black water" leaks from the wall in Main OR #11 located in Pod 2. Review of the Main OR schedule from July 17, 2017 revealed that Patient #5 was in OR #11 at the time the leak was identified. Review of "Theradoc" documentation dated July 20, 2017 at 11:26 AM revealed that on July 19, 2017 "patient was in OR 11 and draped ...when a leak occurred which resulted in sewage draining from the wall ...". Patient #11 was scheduled in the OR for a Debridement of the Abdominal Wall.


A face to face interview was conducted on August 17, 2017 at approximately 1:45 PM with Employees #3, 4, 5, 6, and 10, regarding the leaks in the operating rooms, and the definition of "black water". Employee #5 explained that "black water" describes sewage, and the that leaks that occurred in OR #4 on the third floor, and OR 11 in the Main OR were sewage leaks. S/he went on to say that the cause of the leaks in the Third Floor OR #4 were related to a clogged toilet in the Cardiac Catheterization Lab located above the OR #4. The cause for the leaks in OR #11 were related to a dialysis box that has a water source and is no longer in use in the OR.


When queried about the source of the recurring leaks in room G-139, Employee #5 stated that the cause of the leaks appeared to be "wipes" used by staff, for patient care being, flushed down the toilets causing a drain back up. When asked about the remediation process for the leaks, Employee #10 explained that when there is a leak, infection control comes up with the Infection Control Risk Assessment (ICRA), the industrial hygiene company and comes up with a remediation plan that is then shared with the contracted remediation and restoration construction company, who performs the physical remediation. Once the remediation is complete, the industrial hygiene company gives the all clear, a terminal clean of the room is completed, and the room is re-opened for use.


On August 18, 2017 at approximately 10:00 AM a review of the "Remediation Scope of Work" and summaries of the post-remediation validation assessment, was conducted. These reports are provided to the hospital by the industrial hygiene company. The facility was able to provide reports from all dates with the exception of the July 17, 2017 leak, that occurred in OR #11.


A face to face interview was conducted on August 18, 2017 at approximately 3:50 PM with Employee's #6 and 10, and Contractors #1 and 2 regarding the July17, 2017 leak in OR #11. Employee #6 and 10 stated that they were not made aware of a leak in OR #11 on July 17, 2017. Contractors #1 and 2 both stated that they were not made aware of any leaks on July17, 2017 in OR #11. Contractor #1 stated that the only call they got was with regard to a leak on July 19, 2017. Contractor #1 was able to provide a remediation report for that occurrence.


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10, regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 the maintenance department received a call about a leak from a dialysis box in OR #11. The maintenance staff gained access to the drain by cutting the drywall in the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service within 24 hours. When asked about the hospital policy related to the remediation of sewage leaks, both employees stated there was no policy.


The hospital failed to develop a surgical services policy to proactively implement measures to prevent the recurring sewage leaks in the operating room that had the potential to expose patients to microbial contamination.


A face to face interview was conducted on August 18, 2017 at approximately 6:00 PM with Employees #1, 2, 3, 4, 5, 7, 10, 13, and 19. The acknowledged the findings.

A. Based on observation, review of documents, and staff interviews, it was determined that the Governing Body failed to ensure patients' right to receive care in a safe environment, by failing to adequately address and curtail recurring sewage leaks in the Operating Room (OR), displaying a pattern of ineffective infection control precautions, and potentially exposing patients to microbial contamination (A-0144).


B. Based on observation, review of documents, and staff interviews, it was determined that the Governing Body failed to ensure that the hospital was maintained to ensure an acceptable level of safety and quality, as evidenced by recurring sewage leaks, and potential compromise in patient safety, as it relates to containment of a sterile field during operative procedures (A-0724).


C. Based on review of documents and staff interviews, it was determined that the Governing Body failed to maintain quality standards of patient care, as evidenced by failure to develop and establish a policy with standard procedures to govern the prevention of recurrent water/sewage intrusions in the Operating Room (OR) (A-0951).

Based on observation, review of documents, and staff interviews, it was determined that the Governing Body failed to ensure patients' right to receive care in a safe environment, by failing to adequately address and curtail recurring sewage leaks in the Operating Room (OR); potentially exposing patients to microbial contamination of the sterile environment during operative procedures; seven (7) sewage leaks occurred over an 11-month period between September 2016 and August 2017 wherein seven (7) of 11 patients underwent surgical procedures in the OR during or proximal to the occurrences of water/sewage intrusion. (Patients #1, 4, 5, 6, 7, 8, 9, 10, and 11).

The findings include:


A review of the facility's occurrence reports, and maintenance work orders revealed sewage leaks occurred on seven (7) occasions in Operating Rooms (OR) on the following dates: September 30, 2016, March 27, 2017, July 5, 2017, July 11, 2017, July 17, 2017 and July 19, 2017. On August 17, 2017 at approximately 10:45 AM, during the onsite investigation, the survey team observed an active leak in OR Pod #2.

The observation is detailed as follows:


On August 18, 2017 at approximately 10:45 AM, the surveyors conducted a tour of the Medstar Washington Hospital Center Main Operating Room in the presence of Employees #3, 7, 8, 10, 11, 12, and 13. During the tour, a black, grainy, foul smelling substance was observed on the floor of room G-139, located in Pod #2. Pod #2 houses Operating rooms 7-12. The Operating rooms (7-12) are designated for General Trauma, Orthopedic Trauma, Bariatric surgery, Gynecological surgery, and Spinal Sugery. Employee #10 explained that s/he had just been notified that there was a sewage leak in that room. S/he went on to explain that this is the 3rd time that a leak of that sort occurred in room G-139. G-139 is known as a "Sub-Sterile room" and is located between OR's (Operating Room) 7 and 8. The room houses the back of a decommissioned autoclave, per Employee #10, 11, and 13 the leaks were coming from the drain in the floor under the autoclave.


Review of "Theradoc (a microbiology based system used by the infection control department)" documentation presented to the surveyors July 17, 2017 at approximately 3:00 PM on September 30, 2016 at 10:35 AM revealed, "Patient in OR 7 during leak in room G-139. Patient #5 was undergoing a Tumor Resection of the Right Wrist at the time. Review of a leak remediation report dated March 27, 2017 revealed that on March 23, 2017 there was " ...water loss which occurred in room G-139. The source of the loss was a drain located underneath the decommissioned autoclave ..."


On July 17, 2017 at approximately 12:30 PM the surveyors conducted a review of requested "Work Orders" related to water intrusion in the Operating rooms. The work orders revealed five (5) separate events of water intrusion. In the Third Floor Operating Room #4 there were ceiling leaks on July 5, 7, and 11, 2017. Review of "Theradoc" documentation dated July 5, 2017 at 11:49 AM revealed that on that day, " a flood from above occurred in the operating room". At that time Patient #1 was undergoing a laparoscopic procedure. "Theradoc" documentation dated July 11, 2017 at 3:15 PM revealed that on that day " ...During the surgery a flood occurred from above through the ceiling light fixture ..." Patient #4 was undergoing a laparoscopic procedure at the time of the leak.


On July 17 and 19, 2017 there were "black water" leaks from the wall in Main OR #11 located in Pod 2. Review of the Main OR schedule from July 17, 2017 revealed that Patient #5 was in OR #11 at the time the leak was identified. Review of "Theradoc" documentation dated July 20, 2017 at 11:26 AM revealed that on July 19, 2017 "patient was in OR 11 and draped ...when a leak occurred which resulted in sewage draining from the wall ...". Patient #11 was scheduled in the OR for a Debridement of the Abdominal Wall.


A face to face interview was conducted on August 17, 2017 at approximately 1:45 PM with Employees #3, 4, 5, 6, and 10, regarding the leaks in the operating rooms, and the definition of "black water". Employee #5 explained that "black water" describes sewage, and the that leaks that occurred in OR #4 on the third floor, and OR 11 in the Main OR were sewage leaks. S/he went on to say that the cause of the leaks in the Third Floor OR #4 were related to a clogged toilet in the Cardiac Catheterization Lab located above the OR #4. The cause for the leaks in OR #11 were related to a dialysis box that has a water source and is no longer in use in the OR.


When queried about the source of the recurring leaks in room G-139, Employee #5 stated that the cause of the leaks appeared to be "wipes" used by staff, for patient care being, flushed down the toilets causing a drain back up. When asked about the remediation process for the leaks, Employee #10 explained that when there is a leak, infection control comes up with the Infection Control Risk Assessment (ICRA), the industrial hygiene company and comes up with a remediation plan that is then shared with the contracted remediation and restoration construction company, who performs the physical remediation. Once the remediation is complete, the industrial hygiene company gives the all clear, a terminal clean of the room is completed, and the room is re-opened for use.


On August 18, 2017 at approximately 10:00 AM a review of the "Remediation Scope of Work" and summaries of the post-remediation validation assessment, was conducted. These reports are provided to the hospital by the industrial hygiene company. The facility was able to provide reports from all dates with the exception of the July 17, 2017 leak, that occurred in OR #11.


A face to face interview was conducted on August 18, 2017 at approximately 3:50 PM with Employee's #6 and 10, and Contractors #1 and 2 regarding the July17, 2017 leak in OR #11. Employee #6 and 10 stated that they were not made aware of a leak in OR #11 on July 17, 2017. Contractors #1 and 2 both stated that they were not made aware of any leaks on July17, 2017 in OR #11. Contractor #1 stated that the only call they got was with regard to a leak on July 19, 2017. Contractor #1 was able to provide a remediation report for that occurrence.


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10, regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 the maintenance department received a call about a leak from a dialysis box in OR #11. The maintenance staff gained access to the drain by cutting the drywall in the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service.


Review of the Main Operating Room schedule from July 17 through 19, 2017 revealed that on July 18, 2017, Patients #6, 7, and 8 had procedures in OR #11. A work order dated July 19, 2017 at 8:53 AM revealed that there was once again a complaint of "water coming from the wall" in OR #11 while Patient #9 was undergoing a procedure. The contracted industrial hygiene company provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR#11. " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR 11 and room G155 is suspected to be wet ..."


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10 regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 they got a call about a leak from a dialysis box in OR #11. The maintenance crew gained access to the drain by cutting the drywall the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service. Both employees acknowledged that the full remediation process did not take place for the leak that occurred on July 17, 2017. OR#11 was returned to service in less than 24 hours.

On August 18, 2017 at approximately 4:30 PM, the surveyor reviewed the Main Operating Room schedule, from July 17 through 19, 2017, which revealed Patients #6, 7, and 8 had procedures in OR #11, on July 18, 2017. A work order, dated July 19, 2017 at 8:53 AM, revealed that there was another complaint of "water coming from the wall" in OR #11, this time, while Patient #9 was undergoing a procedure. The contracted, Industrial Hygiene Company, provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR #11. The documentation revealed, " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR #11 and room G155 is suspected to be wet ..."

The hospital failed ensure that patients received care in a safe setting, by continuing to provide services in Operating Rooms, specifically in Pod 2, that repeatedly had multiple sewage leaks, of which five (5) occurrences happened recently, during the month of July 2017.

A review of infection control records, surgical site infection reports and a review of the facility's reporting of healthcare acquired infections, lacked evidence that patients sustained untoward effects or infections as a direct result of the sewage intrusion in the OR.

A face to face interview was conducted on August 18, 2017 at approximately 6:00 PM with Employees #1, 2, 3, 4, 5, 7, 10, 13, and 19. The acknowledged the findings.

Based on observation, documentation review, and staff interviews, it was determined that staff failed to ensure the hospital was maintained in a manner to ensure patient safety and quality of care as evidenced by recurring sewage leaks in operating rooms (OR); potentially exposing patients to microbial contamination of the sterile environment during operative procedures; seven (7) sewage leaks occurred over an 11-month period between September 2016 and August 2017 wherein seven (7) of 11 patients underwent surgical procedures in the OR during or proximal to the occurrences of water/sewage intrusion. (Patients #1, 4, 5, 6, 7, 8, 9, 10, and 11).


The findings include:

A review of the facility's occurrence reports, and maintenance work orders revealed sewage leaks occurred on seven (7) occasions in the OR as follows: September 30, 2016, March 27, 2017, July 5, 2017, July 11, 2017, July 17, 2017 and July 19, 2017. On August 17, 2017 at approximately 10:45 AM, during the onsite investigation, the survey team observed an active leak in OR Pod #2.

The observation is detailed as follows:


On August 18, 2017 at approximately 10:45 AM, the surveyors conducted a tour of the Medstar Washington Hospital Center Main Operating Room in the presence of Employees #3, 7, 8, 10, 11, 12, and 13. During the tour, a black, grainy, foul smelling substance was observed on the floor of room G-139, located in Pod #2. Pod #2 houses Operating rooms 7-12. The Operating rooms (7-12) are designated for General Trauma, Orthopedic Trauma, Bariatric surgery, Gynecological surgery, and Spinal Sugery. Employee #10 explained that s/he had just been notified that there was a sewage leak in that room. S/he went on to explain that this is the 3rd time that a leak of that sort occurred in room G-139. G-139 is known as a "Sub-Sterile room" and is located between OR's (Operating Room) 7 and 8. The room houses the back of a decommissioned autoclave, per Employee #10, 11, and 13 the leaks were coming from the drain in the floor under the autoclave.


Review of "Theradoc (a microbiology based system used by the infection control department)" documentation presented to the surveyors July 17, 2017 at approximately 3:00 PM on September 30, 2016 at 10:35 AM revealed, "Patient in OR 7 during leak in room G-139. Patient #5 was undergoing a Tumor Resection of the Right Wrist at the time. Review of a leak remediation report dated March 27, 2017 revealed that on March 23, 2017 there was " ...water loss which occurred in room G-139. The source of the loss was a drain located underneath the decommissioned autoclave ..."


On July 17, 2017 at approximately 12:30 PM the surveyors conducted a review of requested "Work Orders" related to water intrusion in the Operating rooms. The work orders revealed five (5) separate events of water intrusion. In the Third Floor Operating Room #4 there were ceiling leaks on July 5, 7, and 11, 2017. Review of "Theradoc" documentation dated July 5, 2017 at 11:49 AM revealed that on that day, " a flood from above occurred in the operating room". At that time Patient #1 was undergoing a laparoscopic procedure. "Theradoc" documentation dated July 11, 2017 at 3:15 PM revealed that on that day " ...During the surgery a flood occurred from above through the ceiling light fixture ..." Patient #4 was undergoing a laparoscopic procedure at the time of the leak.


On July 17 and 19, 2017 there were "black water" leaks from the wall in Main OR #11 located in Pod 2. Review of the Main OR schedule from July 17, 2017 revealed that Patient #5 was in OR #11 at the time the leak was identified. Review of "Theradoc" documentation dated July 20, 2017 at 11:26 AM revealed that on July 19, 2017 "patient was in OR 11 and draped ...when a leak occurred which resulted in sewage draining from the wall ...". Patient #11 was scheduled in the OR for a Debridement of the Abdominal Wall.


A face to face interview was conducted on August 17, 2017 at approximately 1:45 PM with Employees #3, 4, 5, 6, and 10, regarding the leaks in the operating rooms, and the definition of "black water". Employee #5 explained that "black water" describes sewage, and the that leaks that occurred in OR #4 on the third floor, and OR 11 in the Main OR were sewage leaks. S/he went on to say that the cause of the leaks in the Third Floor OR #4 were related to a clogged toilet in the Cardiac Catheterization Lab located above the OR #4. The cause for the leaks in OR #11 were related to a dialysis box that has a water source and is no longer in use in the OR.


When queried about the source of the recurring leaks in room G-139, Employee #5 stated that the cause of the leaks appeared to be "wipes" used by staff, for patient care being, flushed down the toilets causing a drain back up. When asked about the remediation process for the leaks, Employee #10 explained that when there is a leak, infection control comes up with the Infection Control Risk Assessment (ICRA), the industrial hygiene company and comes up with a remediation plan that is then shared with the contracted remediation and restoration construction company, who performs the physical remediation. Once the remediation is complete, the industrial hygiene company gives the all clear, a terminal clean of the room is completed, and the room is re-opened for use.


On August 18, 2017 at approximately 10:00 AM a review of the "Remediation Scope of Work" and summaries of the post-remediation validation assessment, was conducted. These reports are provided to the hospital by the industrial hygiene company. The facility was able to provide reports from all dates with the exception of the July 17, 2017 leak, that occurred in OR #11.


A face to face interview was conducted on August 18, 2017 at approximately 3:50 PM with Employee's #6 and 10, and Contractors #1 and 2 regarding the July17, 2017 leak in OR #11. Employee #6 and 10 stated that they were not made aware of a leak in OR #11 on July 17, 2017. Contractors #1 and 2 both stated that they were not made aware of any leaks on July17, 2017 in OR #11. Contractor #1 stated that the only call they got was with regard to a leak on July 19, 2017. Contractor #1 was able to provide a remediation report for that occurrence.


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10, regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 the maintenance department received a call about a leak from a dialysis box in OR #11. The maintenance staff gained access to the drain by cutting the drywall in the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service.


Review of the Main Operating Room schedule from July 17 through 19, 2017 revealed that on July 18, 2017, Patients #6, 7, and 8 had procedures in OR #11. A work order dated July 19, 2017 at 8:53 AM revealed that there was once again a complaint of "water coming from the wall" in OR #11 while Patient #9 was undergoing a procedure. The contracted industrial hygiene company provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR#11. " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR 11 and room G155 is suspected to be wet ..."


The surveyors conducted a telephone interview with Employee #18, on August 18, 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10 regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 they got a call about a leak from a dialysis box in OR #11. The maintenance crew gained access to the drain by cutting the drywall the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service. Both employees acknowledged that the full remediation process did not take place for the leak that occurred on July 17, 2017. OR#11 was returned to service in less than 24 hours.

On August 18, 2017 at approximately 4:30 PM, the surveyor reviewed the Main Operating Room schedule, from July 17 through 19, 2017, which revealed Patients #6, 7, and 8 had procedures in OR #11, on July 18, 2017. A work order, dated July 19, 2017 at 8:53 AM, revealed that there was another complaint of "water coming from the wall" in OR #11, this time, while Patient #9 was undergoing a procedure. The contracted, Industrial Hygiene Company, provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR #11. The documentation revealed, " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR #11 and room G155 is suspected to be wet ..."

The hospital failed ensure that patients received care in a safe setting, by continuing to provide services in Operating Rooms, specifically in Pod 2, that repeatedly had multiple sewage leaks, of which five (5) occurrences happened recently, during the month of July 2017.

A review of infection control records, surgical site infection reports and a review of the facility's reporting of healthcare acquired infections, lacked evidence that patients sustained untoward effects or infections as a direct result of the sewage intrusion in the OR.

A face to face interview was conducted on August 18, 2017 at approximately 6:00 PM with Employees #1, 2, 3, 4, 5, 7, 10, 13, and 19. The acknowledged the findings.

Based on observation, documentation review, and staff interviews, it was determined that staff failed to ensure the hospital was maintained in a manner to ensure patient safety and quality of care as evidenced by recurring sewage leaks in operating rooms (OR); potentially exposing patients to microbial contamination of the sterile environment during operative procedures; seven (7) sewage leaks occurred over an 11-month period between September 2016 and August 2017 wherein seven (7) of 11 patients underwent surgical procedures in the OR during or proximal to the occurrences of water/sewage intrusion. (Patients #1, 4, 5, 6, 7, 8, 9, 10, and 11).

An Immediate Jeopardy (IJ) was identified at 42 CFR 482.12 (b ) Facilities must be maintained to ensure an acceptable level of safety and quality. Failure to provide safety from environmental hazards and waste in operating rooms. The notification of the IJ was made on Friday, August 18, 2017 at 5:45 PM.

The facility's Leadership provided a letter noting a corrective action plan on Friday, August 18, 2017 at 7:30 PM. The IJ was removed on August 21, 2017.

The findings include:

A review of the facility's occurrence reports, and maintenance work orders revealed sewage leaks occurred on seven (7) occasions in the OR as follows: September 30, 2016, March 27, 2017, July 5, 2017, July 11, 2017, July 17, 2017 and July 19, 2017. On August 17, 2017 at approximately 10:45 AM, during the onsite investigation, the survey team observed an active leak in OR Pod #2.

The observation is detailed as follows:


On August 18, 2017 at approximately 10:45 AM, the surveyors conducted a tour of the Medstar Washington Hospital Center Main Operating Room in the presence of Employees #3, 7, 8, 10, 11, 12, and 13. During the tour, a black, grainy, foul smelling substance was observed on the floor of room G-139, located in Pod #2. Pod #2 houses Operating rooms 7-12. The Operating rooms (7-12) are designated for General Trauma, Orthopedic Trauma, Bariatric surgery, Gynecological surgery, and Spinal Sugery. Employee #10 explained that s/he had just been notified that there was a sewage leak in that room. S/he went on to explain that this is the 3rd time that a leak of that sort occurred in room G-139. G-139 is known as a "Sub-Sterile room" and is located between OR's (Operating Room) 7 and 8. The room houses the back of a decommissioned autoclave, per Employee #10, 11, and 13 the leaks were coming from the drain in the floor under the autoclave.


Review of "Theradoc (a microbiology based system used by the infection control department)" documentation presented to the surveyors July 17, 2017 at approximately 3:00 PM on September 30, 2016 at 10:35 AM revealed, "Patient in OR 7 during leak in room G-139. Patient #5 was undergoing a Tumor Resection of the Right Wrist at the time. Review of a leak remediation report dated March 27, 2017 revealed that on March 23, 2017 there was " ...water loss which occurred in room G-139. The source of the loss was a drain located underneath the decommissioned autoclave ..."


On July 17, 2017 at approximately 12:30 PM the surveyors conducted a review of requested "Work Orders" related to water intrusion in the Operating rooms. The work orders revealed five (5) separate events of water intrusion. In the Third Floor Operating Room #4 there were ceiling leaks on July 5, 7, and 11, 2017. Review of "Theradoc" documentation dated July 5, 2017 at 11:49 AM revealed that on that day, " a flood from above occurred in the operating room". At that time Patient #1 was undergoing a laparoscopic procedure. "Theradoc" documentation dated July 11, 2017 at 3:15 PM revealed that on that day " ...During the surgery a flood occurred from above through the ceiling light fixture ..." Patient #4 was undergoing a laparoscopic procedure at the time of the leak.


On July 17 and 19, 2017 there were "black water" leaks from the wall in Main OR #11 located in Pod 2. Review of the Main OR schedule from July 17, 2017 revealed that Patient #5 was in OR #11 at the time the leak was identified. Review of "Theradoc" documentation dated July 20, 2017 at 11:26 AM revealed that on July 19, 2017 "patient was in OR 11 and draped ...when a leak occurred which resulted in sewage draining from the wall ...". Patient #11 was scheduled in the OR for a Debridement of the Abdominal Wall.


A face to face interview was conducted on August 17, 2017 at approximately 1:45 PM with Employees #3, 4, 5, 6, and 10, regarding the leaks in the operating rooms, and the definition of "black water". Employee #5 explained that "black water" describes sewage, and the that leaks that occurred in OR #4 on the third floor, and OR 11 in the Main OR were sewage leaks. S/he went on to say that the cause of the leaks in the Third Floor OR #4 were related to a clogged toilet in the Cardiac Catheterization Lab located above the OR #4. The cause for the leaks in OR #11 were related to a dialysis box that has a water source and is no longer in use in the OR.


When queried about the source of the recurring leaks in room G-139, Employee #5 stated that the cause of the leaks appeared to be "wipes" used by staff, for patient care being, flushed down the toilets causing a drain back up. When asked about the remediation process for the leaks, Employee #10 explained that when there is a leak, infection control comes up with the Infection Control Risk Assessment (ICRA), the industrial hygiene company and comes up with a remediation plan that is then shared with the contracted remediation and restoration construction company, who performs the physical remediation. Once the remediation is complete, the industrial hygiene company gives the all clear, a terminal clean of the room is completed, and the room is re-opened for use.


On August 18, 2017 at approximately 10:00 AM a review of the "Remediation Scope of Work" and summaries of the post-remediation validation assessment, was conducted. These reports are provided to the hospital by the industrial hygiene company. The facility was able to provide reports from all dates with the exception of the July 17, 2017 leak, that occurred in OR #11.


A face to face interview was conducted on August 18, 2017 at approximately 3:50 PM with Employee's #6 and 10, and Contractors #1 and 2 regarding the July17, 2017 leak in OR #11. Employee #6 and 10 stated that they were not made aware of a leak in OR #11 on July 17, 2017. Contractors #1 and 2 both stated that they were not made aware of any leaks on July17, 2017 in OR #11. Contractor #1 stated that the only call they got was with regard to a leak on July 19, 2017. Contractor #1 was able to provide a remediation report for that occurrence.


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10, regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 the maintenance department received a call about a leak from a dialysis box in OR #11. The maintenance staff gained access to the drain by cutting the drywall in the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service.


Review of the Main Operating Room schedule from July 17 through 19, 2017 revealed that on July 18, 2017, Patients #6, 7, and 8 had procedures in OR #11. A work order dated July 19, 2017 at 8:53 AM revealed that there was once again a complaint of "water coming from the wall" in OR #11 while Patient #9 was undergoing a procedure. The contracted industrial hygiene company provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR#11. " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR 11 and room G155 is suspected to be wet ..."


The surveyors conducted a telephone interview with Employee #18, on August 18, 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10 regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 they got a call about a leak from a dialysis box in OR #11. The maintenance crew gained access to the drain by cutting the drywall the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service. Both employees acknowledged that the full remediation process did not take place for the leak that occurred on July 17, 2017. OR#11 was returned to service in less than 24 hours.

On August 18, 2017 at approximately 4:30 PM, the surveyor reviewed the Main Operating Room schedule, from July 17 through 19, 2017, which revealed Patients #6, 7, and 8 had procedures in OR #11, on July 18, 2017. A work order, dated July 19, 2017 at 8:53 AM, revealed that there was another complaint of "water coming from the wall" in OR #11, this time, while Patient #9 was undergoing a procedure. The contracted, Industrial Hygiene Company, provided a "Remediation Scope of Work" that revealed the leak occurred in room G-155 and OR #11. The documentation revealed, " ...The source of the water was a dialysis water line which was previously removed from service and capped ...The OR side of the partition between OR #11 and room G155 is suspected to be wet ..."

The hospital failed ensure that patients received care in a safe setting, by continuing to provide services in Operating Rooms, specifically in Pod 2, that repeatedly had multiple sewage leaks, of which five (5) occurrences happened recently, during the month of July 2017.

A review of infection control records, surgical site infection reports and a review of the facility's reporting of healthcare acquired infections, lacked evidence that patients sustained untoward effects or infections as a direct result of the sewage intrusion in the OR.

A face to face interview was conducted on August 18, 2017 at approximately 6:00 PM with Employees #1, 2, 3, 4, 5, 7, 10, 13, and 19. The acknowledged the findings.


B. Based on document review and staff interview, it was determined that the Governing Body failed to maintain quality standards of patient care, as evidenced by failure to develop a policy, with standard procedures to govern the prevention of recurrent water/sewage intrusion in the Operating Room.


The findings include:


On August 18, 2017 at approximately 10:45 AM, the surveyors conducted a tour of the Medstar Washington Hospital Center Main Operating Room in the presence of Employees #3, 7, 8, 10, 11, 12, and 13. During the tour ,a black, grainy, foul smelling substance was observed on the floor of room G-139, located in Pod #2. Pod #2 houses Operating rooms 7-12. The Operating rooms are designated for General Trauma, Orthopedic Trauma, Bariatric surgery, Gynecological surgery, and Spinal Sugery. Employee #10 explained that s/he had just been notified that there was a sewage leak in that room. S/he went on to explain that this is the 3rd time that a leak of that sort occurred in room G-139. G-139 is known as a "Sub-Sterile room" and is located between OR's (Operating Room) 7 and 8. The room houses the back of a decommissioned autoclave, per Employee #10, 11, and 13 the leaks were coming from the drain in the floor under the autoclave.


Review of "Theradoc (a microbiology based system used by the infection control department)" documentation presented to the surveyors July 17, 2017 at approximately 3:00 PM on September 30, 2016 at 10:35 AM revealed, "Patient in OR 7 during leak in room G-139. Patient #5 was undergoing a Tumor Resection of the Right Wrist at the time. Review of a leak remediation report dated March 27, 2017 revealed that on March 23, 2017 there was " ...water loss which occurred in room G-139. The source of the loss was a drain located underneath the decommissioned autoclave ..."


On August 17, 2017 at approximately 12:30 PM the surveyors conducted a review of requested "Work Orders" related to water intrusion in the Operating rooms. The work orders revealed five (5) separate events of water intrusion. In the Third Floor Operating Room #4 there were ceiling leaks on July 5, 7, and 11, 2017. Review of "Theradoc" documentation dated July 5, 2017 at 11:49 AM revealed that on that day, " a flood from above occurred in the operating room". At that time Patient #1 was undergoing a laparoscopic procedure. "Theradoc" documentation dated July 11, 2017 at 3:15 PM revealed that on that day " ...During the surgery a flood occurred from above through the ceiling light fixture ..." Patient #4 was undergoing a laparoscopic procedure at the time of the leak.


On July 17 and 19, 2017 there were "black water" leaks from the wall in Main OR #11 located in Pod 2. Review of the Main OR schedule from July 17, 2017 revealed that Patient #5 was in OR #11 at the time the leak was identified. Review of "Theradoc" documentation dated July 20, 2017 at 11:26 AM revealed that on July 19, 2017 "patient was in OR 11 and draped ...when a leak occurred which resulted in sewage draining from the wall ...". Patient #11 was scheduled in the OR for a Debridement of the Abdominal Wall.


A face to face interview was conducted on August 17, 2017 at approximately 1:45 PM with Employees #3, 4, 5, 6, and 10, regarding the leaks in the operating rooms, and the definition of "black water". Employee #5 explained that "black water" describes sewage, and the that leaks that occurred in OR #4 on the third floor, and OR 11 in the Main OR were sewage leaks. S/he went on to say that the cause of the leaks in the Third Floor OR #4 were related to a clogged toilet in the Cardiac Catheterization Lab located above the OR #4. The cause for the leaks in OR #11 were related to a dialysis box that has a water source and is no longer in use in the OR.


When queried about the source of the recurring leaks in room G-139, Employee #5 stated that the cause of the leaks appeared to be "wipes" used by staff, for patient care being, flushed down the toilets causing a drain back up. When asked about the remediation process for the leaks, Employee #10 explained that when there is a leak, infection control comes up with the Infection Control Risk Assessment (ICRA), the industrial hygiene company and comes up with a remediation plan that is then shared with the contracted remediation and restoration construction company, who performs the physical remediation. Once the remediation is complete, the industrial hygiene company gives the all clear, a terminal clean of the room is completed, and the room is re-opened for use.


On August 18, 2017 at approximately 10:00 AM a review of the "Remediation Scope of Work" and summaries of the post-remediation validation assessment, was conducted. These reports are provided to the hospital by the industrial hygiene company. The facility was able to provide reports from all dates with the exception of the July 17, 2017 leak, that occurred in OR #11.


A face to face interview was conducted on August 18, 2017 at approximately 3:50 PM with Employee's #6 and 10, and Contractors #1 and 2 regarding the July17, 2017 leak in OR #11. Employee #6 and 10 stated that they were not made aware of a leak in OR #11 on July 17, 2017. Contractors #1 and 2 both stated that they were not made aware of any leaks on July17, 2017 in OR #11. Contractor #1 stated that the only call they got was with regard to a leak on July 19, 2017. Contractor #1 was able to provide a remediation report for that occurrence.


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10, regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 the maintenance department received a call about a leak from a dialysis box in OR #11. The maintenance staff gained access to the drain by cutting the drywall in the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service within 24 hours. When asked about the hospital policy related to the remediation of sewage leaks, both employees stated there was no policy.


The hospital failed to develop a surgical services policy to proactively implement measures to prevent the recurring sewage leaks in the operating room that had the potential to expose patients to microbial contamination.


A face to face interview was conducted on August 18, 2017 at approximately 6:00 PM with Employees #1, 2, 3, 4, 5, 7, 10, 13, and 19. The acknowledged the findings.

Based on document review and staff interview, it was determined that the hospital staff failed to maintain quality standards of patient care, as evidenced by failure to develop a policy, with standard procedures to govern the prevention of recurrent water/sewage intrusion in the Operating Room.


The findings include:


On August 18, 2017 at approximately 10:45 AM, the surveyors conducted a tour of the Medstar Washington Hospital Center Main Operating Room in the presence of Employees #3, 7, 8, 10, 11, 12, and 13. During the tour ,a black, grainy, foul smelling substance was observed on the floor of room G-139, located in Pod #2. Pod #2 houses Operating rooms 7-12. The Operating rooms are designated for General Trauma, Orthopedic Trauma, Bariatric surgery, Gynecological surgery, and Spinal Sugery. Employee #10 explained that s/he had just been notified that there was a sewage leak in that room. S/he went on to explain that this is the 3rd time that a leak of that sort occurred in room G-139. G-139 is known as a "Sub-Sterile room" and is located between OR's (Operating Room) 7 and 8. The room houses the back of a decommissioned autoclave, per Employee #10, 11, and 13 the leaks were coming from the drain in the floor under the autoclave.


Review of "Theradoc (a microbiology based system used by the infection control department)" documentation presented to the surveyors July 17, 2017 at approximately 3:00 PM on September 30, 2016 at 10:35 AM revealed, "Patient in OR 7 during leak in room G-139. Patient #5 was undergoing a Tumor Resection of the Right Wrist at the time. Review of a leak remediation report dated March 27, 2017 revealed that on March 23, 2017 there was " ...water loss which occurred in room G-139. The source of the loss was a drain located underneath the decommissioned autoclave ..."


On August 17, 2017 at approximately 12:30 PM the surveyors conducted a review of requested "Work Orders" related to water intrusion in the Operating rooms. The work orders revealed five (5) separate events of water intrusion. In the Third Floor Operating Room #4 there were ceiling leaks on July 5, 7, and 11, 2017. Review of "Theradoc" documentation dated July 5, 2017 at 11:49 AM revealed that on that day, " a flood from above occurred in the operating room". At that time Patient #1 was undergoing a laparoscopic procedure. "Theradoc" documentation dated July 11, 2017 at 3:15 PM revealed that on that day " ...During the surgery a flood occurred from above through the ceiling light fixture ..." Patient #4 was undergoing a laparoscopic procedure at the time of the leak.


On July 17 and 19, 2017 there were "black water" leaks from the wall in Main OR #11 located in Pod 2. Review of the Main OR schedule from July 17, 2017 revealed that Patient #5 was in OR #11 at the time the leak was identified. Review of "Theradoc" documentation dated July 20, 2017 at 11:26 AM revealed that on July 19, 2017 "patient was in OR 11 and draped ...when a leak occurred which resulted in sewage draining from the wall ...". Patient #11 was scheduled in the OR for a Debridement of the Abdominal Wall.


A face to face interview was conducted on August 17, 2017 at approximately 1:45 PM with Employees #3, 4, 5, 6, and 10, regarding the leaks in the operating rooms, and the definition of "black water". Employee #5 explained that "black water" describes sewage, and the that leaks that occurred in OR #4 on the third floor, and OR 11 in the Main OR were sewage leaks. S/he went on to say that the cause of the leaks in the Third Floor OR #4 were related to a clogged toilet in the Cardiac Catheterization Lab located above the OR #4. The cause for the leaks in OR #11 were related to a dialysis box that has a water source and is no longer in use in the OR.


When queried about the source of the recurring leaks in room G-139, Employee #5 stated that the cause of the leaks appeared to be "wipes" used by staff, for patient care being, flushed down the toilets causing a drain back up. When asked about the remediation process for the leaks, Employee #10 explained that when there is a leak, infection control comes up with the Infection Control Risk Assessment (ICRA), the industrial hygiene company and comes up with a remediation plan that is then shared with the contracted remediation and restoration construction company, who performs the physical remediation. Once the remediation is complete, the industrial hygiene company gives the all clear, a terminal clean of the room is completed, and the room is re-opened for use.


On August 18, 2017 at approximately 10:00 AM a review of the "Remediation Scope of Work" and summaries of the post-remediation validation assessment, was conducted. These reports are provided to the hospital by the industrial hygiene company. The facility was able to provide reports from all dates with the exception of the July 17, 2017 leak, that occurred in OR #11.


A face to face interview was conducted on August 18, 2017 at approximately 3:50 PM with Employee's #6 and 10, and Contractors #1 and 2 regarding the July17, 2017 leak in OR #11. Employee #6 and 10 stated that they were not made aware of a leak in OR #11 on July 17, 2017. Contractors #1 and 2 both stated that they were not made aware of any leaks on July17, 2017 in OR #11. Contractor #1 stated that the only call they got was with regard to a leak on July 19, 2017. Contractor #1 was able to provide a remediation report for that occurrence.


The surveyors conducted a telephone interview with Employee #18, on August 18 2017 at approximately 4:05 PM, in the presence of Employees #6 and 10, regarding the leak in OR #11. Employee #18 stated that on July 17, 2017 the maintenance department received a call about a leak from a dialysis box in OR #11. The maintenance staff gained access to the drain by cutting the drywall in the adjacent room, Room G-155. The drain was snaked and the drywall was repaired, OR #11 was terminally cleaned and the room was returned to service within 24 hours. When asked about the hospital policy related to the remediation of sewage leaks, both employees stated there was no policy.


The hospital failed to develop a surgical services policy to proactively implement measures to prevent the recurring sewage leaks in the operating room that had the potential to expose patients to microbial contamination.


A face to face interview was conducted on August 18, 2017 at approximately 6:00 PM with Employees #1, 2, 3, 4, 5, 7, 10, 13, and 19. The acknowledged the findings.