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MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on a tour of the hospital Cancer Center Pharmacy, review of hospital documentation, review of hospital policies and interviews with hospital personnel, documentation and interviews failed to reflect that the Governing Body was informed of the Pharmacy Environmental Testing results. In addition, the hospital failed to ensure that the Governing Body was informed prior to the reoccupation of a patient care unit of the hospital which was identified with significant water damage and and microbial growth, when remediation had not been completed, and the unit had not been deemed safe for patients. The findings include:

1a. Air sampling: Review of the hospital environmental testing vendor documentation dated 10/2/14 identified air samples with actionable levels of fungus and yeast in the Cancer Center pharmacy's clean room and anteroom. The organisms of concern were Trichophyton (fungus) in the clean room buffer area and Rhodotorola (yeast) in the anteroom. Review of the hospital's USP 797 Environmental Policies and Procedures indicated that all logs and certification records would be maintained and reviewed by supervisory personnel or other designated employees to ensure controlled environments comply with proper air cleanliness. The Policy indicated that sampling data would be collected and reviewed by IV room supervisory personnel with all positive samples reported to the Pharmacy Director. Documentation and interview with the Pharmacy Director failed to reflect a remediation was completed for the actionable results on 10/2/14.

2a. Surface sampling: Review of the hospital Cancer Center Envirotest Log dated 12/9/14 noted that the pharmacy's anteroom surface testing results identified 40 Colony Forming Units (CFUs). Two weeks later (?12/23/14 on the same form), the CFUs were identified as gram positive cocci in pairs and clusters, but failed to identify the genus/species. The hospital's USP 797 Environmental Policy indicated that the CFU should be identified at least on the genus level. The Log failed to identify who prepared the samples and which surface areas were sampled. Additionally, The Envirotest Log dated 12/9/14 had omissions and discrepancies in the documentation. The Log failed to identify which of the hospital's pharmacies was sampled (main vs Cancer Center). The IV clean room and the anteroom were mislabeled on the Log. Interview with the Pharmacy Director on 1/15/15 and 1/16/15 indicated that the Log dated 12/9/14 was the Cancer Center Pharmacy's clean room and anteroom.
2b. Review of hospital documentation identified anteroom International Organization for Standardization (ISO) level discrepancies in the Cancer Center pharmacy. The hospital vendor's Monitoring Plan for Viable Particles documentation dated 9/25/13 indicated that the anteroom was ISO 7, however, the hospital vendor's Monitoring Plan for Viable Particles documentation dated 3/27/14 identified the level as ISO 8. Review of the hospital's USP 797 Environmental Policy indicated that the anteroom was designated ISO 7 and that the CFU count should be < 10, whereas, an ISO 8 level should be <100. The Policy also indicated that in the event that an environmental sample exceeded the threshold, an investigation and corrective procedures would be taken: The Environmental Monitoring Action Plan. The Plan directed staff re-education and thorough cleaning of all compounding space followed by a 5 consecutive day monitoring. Interview with Pharmacy Technician #1 on 1/15/14 indicated that he/she was unable to identify the communication process between the microbiology lab and pharmacy for obtaining the environmental testing results. Interview with the Microbiology Manager on 1/13/15 identified that the microbiology lab copies the log and sends the original log back to the pharmacy. The Microbiology Manager was not aware of any remedial action taken. The USP 797 Environmental Policy indicated that the sampling data would be collected and reviewed by the IV Room Supervisor with all positive results reported to the Pharmacy Director. Interview with the Pharmacy Director on 1/16/15 indicated that he/she was aware of the surface testing results on 12/9/14. Furthermore, the Policy indicated that any CFU count that exceeds its respective action level shall prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures and air filtration within the compounding area. Documentation and interviews failed to reflect if the CFU count was actionable and if proper remediation had been conducted.

2c. The hospital's USP 797 Environmental Policy indicated that periodic reports were to be made to the infection control committee. Review of hospital documentation and interviews with the Cancer Center Administrator, the Infection Preventionist on 1/15/15 and with the Cancer Center Medical Director on 1/16/15 identified that they were unaware of the testing results. The Infection Preventionist identified that he/she would expect the results to be given to the him/her and/or to the Infectious Disease Director.


3a. Review of facility documentation and interview with Nurse Manager (NM) #4 on 01/15/15 identified that on the afternoon of 12/24/14, water leaks were observed in three patient rooms on one of the two hallways of the telemetry unit. The Manager of Facilities Operations and the Assistant Director of Nursing (ADN) #1 were notified and the patients were moved to the unaffected hallway. Interview with the Director of Patient Care Services and ADN #1 on 01/13/15 at 4:10 PM identified that the leaking continued throughout the night and in addition to the patient rooms, the leak affected the clean utility rooms, the hallway in the entrance to the unit and the nursing station. Plastic tubing had been placed in the drains that extended into buckets positioned on the floor of the affected areas to prevent pooling of water. On 12/25/14, ADN #1 consulted with MD #10 (Hospitalist on duty) and MD #11 (Cardiologist on duty), and based on concerns for patient safety, the decision was made to relocate all patients from both sides of the telemetry unit to other units of the hospital until the water problem could be remediated. The patients were relocated to appropriate units on 12/25/14 without interruption in care and services.

A projected plan for water damage remediation and the relocation of patients on the telemetry unit was documented by the Assistant Chief Nursing Officer (ACNO) #1 and forwarded to Vice President (VP)/CEO, NM #4, ACNO #2/Director of Patient Care Services, Manager of Facility Operations, Director of Facilities, and Cardiologists and Physician Assistants (PA) on 12/26/14 at 4:56 PM. The plan included the clean-up and drying of the unit on 12/26, 12/27, and 12/28/14. Construction/replacement parts were to be delivered on 12/29/14, and repair work was expected to be completed on 12/30/14 followed by cleaning of unit. The unit was projected to reopen on 12/31/14.

Additional documentation by ACNO #1 dated 12/27/14 at 8:15 AM was distributed to Patient Care Services, the ADNs, ACNO #2, and NM #4. The documentation identified that the unit was still closed with hopes of completing the work, cleaning the unit, and reopening on 12/31/14. Between 12/27/14 and 12/31/14, the proposed management of new hospital admissions included to fill open beds on other units, open another unit (3.6) that had been closed which was cleaned and stocked.

On 12/28/14, ACNO #1 documented an update that was forwarded to ADNS #1, Manager of Facility Operations, Director of Material Management, Program Manager/Infection Prevention, ACNO #2, Director #1, VP/Chief Human Services Officer, and MD #1. The update identified that due to increasing patient admissions, "we" have reassessed the opening of a portion of the telemetry unit (5.4). ADNS #1 and the Manager of Facility Operations proposed to open the unaffected side of the unit within 4 hours, clean the main hallway, clean and restock the clean utility room, replace affected ceiling tiles, and clean the nursing station. In addition, wait to open unit 3.6 as reopening of a portion of 5.4 would be more beneficial (providing more open beds).

Interview with the Safety Manager on 01/14/14 at 10:50 AM identified that he/she was informed of the leak and the need for relocation of the patients from unit 5.4. He/she toured 5.4 on 12/26/14 and recommended ongoing monitoring for mold, particulate count for dust. Air Quality Consultant #1 was contacted and scheduled testing for 12/31/14. The Safety Manager identified that he/she had directed that unit 5.4 should remain patient free until 12/31/14. On 12/31/14 ceiling tiles had been replaced and hallway cleaning had been completed, however, drains and bucket collecting systems remained in the areas affected by the leaks. The Safety Manager identified that he/she was not consulted prior to patients being admitted to unit 5.4 on 12/28/14, was not aware of the unit reopening until 12/29/14, and was concerned that patients were admitted to unit 5.4 before the results of the air quality testings were received.

Review of an Indoor Air Quality and Environmental Fungi (mold) Evaluation identified that air samplings for environmental fungi were collected on 12/31/14 with microbial growth in the following areas: 13 cfu's/M3 in the hallway by room 5.440 and 40 cfu'/M3 in clean utility room 5.443. Low level counts of Aspergillus/Penicillium and Basidiospores were also detected.

Interview with the Manager of Facilities Operation on 01/16/15 at 1:00 PM identified that he/she was not involved with the decision to reopen unit 5.4 on 12/28/14. As of 12/26/14, the plan was to reopen the unit on 12/31/14. On 12/26/14, patient rooms with active leaks were closed and all wet materials including tiles were removed. Six tiles had also been removed in the nursing station and hallway. The Manager of Facilities Operation was notified by the ACNO on 12/28/14 that the unit needed to be opened within 4 hours. He/she replaced six ceiling tiles, which were cut at the nursing station. Remaining dust and debris was vacuumed, but surfaces were not wiped down. No work was completed in the affected resident rooms or the clean utility room.

Interview with the Director of Environmental Services on 1/15/15 at 12:20 PM identified that he/she had been informed of the leak on unit 5.4 on 12/25/14 and directed the Environmental Services staff to terminally clean all unaffected patient rooms. The cleaning was completed on 12/26/14. The Director of Environmental Services instructed the staff to clean all rooms and nursing station on 12/28/14 in preparation for the unit reopening and he/she toured the unit and inspected all the unaffected rooms. The rooms appeared clean and ready for occupancy. The affected rooms could not be cleaned and inspection identified that ceiling tiles were not in place and the doors were closed. Tacky mats had been placed on the threshold of each room. The Director of Environmental Services did not inspect the Nursing Station, however additional concerns regarding dust were brought to his/her attention on 12/29/14 and an additional housekeeper was added to the staffing to focus on cleaning the hallway and nursing station. The increased amount of dust was noted throughout the unit after the unit was reopened and occupied with patients.

Interview with the Program Manager/Infection Prevention Nurse on 01/14/15 at 3:00 PM identified that he/she was not notified of the water issue and/or relocation of patients on 12/24/2014 or 12/25/14 but would have expected to have been notified. He/she was notified on 12/26/14 and toured the unit, making recommendations for cleaning. He/she identified an area of mold like substance in the hallway. He/she communicated to the rest of the Infection Control staff that there was plenty of time for cleaning to be completed after all the repairs and remediation were finished as the unit was not projected to be reopened until 12/31/14. The Program Manager was notified on 12/28/14 that patients were to be readmitted to unit 5.4 within 4 hours but was not involved in the decision. He/she was not in the facility at the time but instructed the infection control staff to ensure that terminal cleaning had been performed and that equipment had been discarded and/or cleaned. All tasks had not been completed prior to patients being admitted to the unit. Additionally, he/she was not informed that an air quality study had been performed until the results were received on 01/12/15.

Interview with MD #3, the Chief of Medicine and Director of Infection Control, identified that he/she had not been consulted regarding the decision to readmit patients to unit 5.4.

Although patients were initially admitted to rooms on a hallway that was not directly affected by the water leaks, access to the hallway required passage through the affected hallway and past the affected rooms and nursing station. A doorway in the affected hallway remained open and remediation continued in the affected rooms allowing free circulation of air between the hallways. The clean utility room had not been remediated when the unit opened, requiring nursing staff to obtain needed supplies from other units. Additionally, tubing and buckets remained in the nursing station, hallway, and affected rooms until remediation was complete, creating a potential for standing water and increased moisture as well as tripping hazards in the unit environment.

3b. The surveyor, accompanied by the Director of Facilities, observed that the walls and ceilings throughout the 5.4 Cardiac Care Unit showed signs of roof leaks/water infiltration. An interview of staff revealed that there was a roof leak on December 24th, 2014 and fifteen (15) patients were relocated from this unit to other patient care areas within the facility. Patients were returned to the affected areas on December 27th 2014 prior to an indoor air quality test being conducted to ensure the safety to patients and occupants of the unit. An indoor air quality test was conducted on December 31st 2014 by an accredited lab contracted by the facility and the documented results were completed on January 12, 2015 and forwarded to the facility.

An interview conducted with the facility's Safety Manager and Engineering staff on January 13, 2015 revealed that the facility had no plan to continue indoor air quality monitoring in this space.

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on a tour of the hospital Cancer Center Pharmacy, review of hospital documentation, review of hospital policies and interviews with hospital personnel, documentation and interviews failed to reflect that the Pharmacy Environmental Testing Policy and the hospital's USP 797 Environmental Policies were followed. The findings include:

1a. Air sampling: Review of the hospital environmental testing vendor documentation dated 10/2/14 identified air samples with actionable levels of fungus and yeast in the Cancer Center pharmacy's clean room and anteroom. The organisms of concern were Trichophyton (fungus) in the clean room buffer area and Rhodotorola (yeast) in the anteroom. Review of the hospital's USP 797 Environmental Policies and Procedures indicated that all logs and certification records would be maintained and reviewed by supervisory personnel or other designated employees to ensure controlled environments comply with proper air cleanliness. The Policy indicated that sampling data would be collected and reviewed by IV room supervisory personnel with all positive samples reported to the Pharmacy Director. Documentation and interview with the Pharmacy Director failed to reflect a remediation was completed for the actionable results on 10/2/14.

2a. Surface sampling: Review of the hospital Cancer Center Envirotest Log dated 12/9/14 noted that the pharmacy's anteroom surface testing results identified 40 Colony Forming Units (CFUs). Two weeks later (?12/23/14 on the same form), the CFUs were identified as gram positive cocci in pairs and clusters, but failed to identify the genus/species. The hospital's USP 797 Environmental Policy indicated that the CFU should be identified at least on the genus level. The Log failed to identify who prepared the samples and which surface areas were sampled. Additionally, The Envirotest Log dated 12/9/14 had omissions and discrepancies in the documentation. The Log failed to identify which of the hospital's pharmacies was sampled (main vs Cancer Center). The IV clean room and the anteroom were mislabeled on the Log. Interview with the Pharmacy Director on 1/15/15 and 1/16/15 indicated that the Log dated 12/9/14 was the Cancer Center Pharmacy's clean room and anteroom.
2b. Review of hospital documentation identified anteroom International Organization for Standardization (ISO) level discrepancies in the Cancer Center pharmacy. The hospital vendor's Monitoring Plan for Viable Particles documentation dated 9/25/13 indicated that the anteroom was ISO 7, however, the hospital vendor's Monitoring Plan for Viable Particles documentation dated 3/27/14 identified the level as ISO 8. Review of the hospital's USP 797 Environmental Policy indicated that the anteroom was designated ISO 7 and that the CFU count should be < 10, whereas, an ISO 8 level should be <100. The Policy also indicated that in the event that an environmental sample exceeded the threshold, an investigation and corrective procedures would be taken: The Environmental Monitoring Action Plan. The Plan directed staff re-education and thorough cleaning of all compounding space followed by a 5 consecutive day monitoring. Interview with Pharmacy Technician #1 on 1/15/14 indicated that he/she was unable to identify the communication process between the microbiology lab and pharmacy for obtaining the environmental testing results. Interview with the Microbiology Manager on 1/13/15 identified that the microbiology lab copies the log and sends the original log back to the pharmacy. The Microbiology Manager was not aware of any remedial action taken. The USP 797 Environmental Policy indicated that the sampling data would be collected and reviewed by the IV Room Supervisor with all positive results reported to the Pharmacy Director. Interview with the Pharmacy Director on 1/16/15 indicated that he/she was aware of the surface testing results on 12/9/14. Furthermore, the Policy indicated that any CFU count that exceeds its respective action level shall prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures and air filtration within the compounding area. Documentation and interviews failed to reflect if the CFU count was actionable and if proper remediation had been conducted.

2c. The hospital's USP 797 Environmental Policy indicated that periodic reports were to be made to the infection control committee. Review of hospital documentation and interviews with the Cancer Center Administrator, the Infection Preventionist on 1/15/15 and with the Cancer Center Medical Director on 1/16/15 identified that they were unaware of the testing results. The Infection Preventionist identified that he/she would expect the results to be given to the him/her and/or to the Infectious Disease Director.

MAINTENANCE OF PHYSICAL PLANT

Tag No.: A0701

Based on a tour of the hospital Cancer Center Pharmacy, review of hospital documentation, review of hospital policies and interviews with hospital personnel, the hospital failed to ensure that the environment in the Cancer Center's pharmacy was free of actionable levels of microbial growth in the Intravenous (IV) preparation areas, and/or failed to ensure that the hospital's environmental response to the actionable levels of microbial growth was prompt and effectively remediated, and/or that the Pharmacy Environmental Testing Policy and the hospital's USP 797 Environmental Policies were followed. and based on observation, review of clinical records, staff interviews, review of hospital email streams and hospital policy and procedures related to water leaks requiring the evacuation of one in-patient unit (unit 5.4), the hospital failed to ensure that the unit affected by the leaks was not reoccupied until deemed safe for patients. In addition, the remediation (replacement of wall boards and ceiling tiles) occurred while the unit was occupied with patients creating dust and other environmental concerns. The findings include:


1a. Air sampling: Review of the hospital environmental testing vendor documentation dated 10/2/14 identified air samples with actionable levels of fungus and yeast in the Cancer Center pharmacy's clean room and anteroom. The organisms of concern were Trichophyton (fungus) in the clean room buffer area and Rhodotorola (yeast) in the anteroom. Review of the hospital's USP 797 Environmental Policies and Procedures indicated that all logs and certification records would be maintained and reviewed by supervisory personnel or other designated employees to ensure controlled environments comply with proper air cleanliness. The Policy indicated that sampling data would be collected and reviewed by IV room supervisory personnel with all positive samples reported to the Pharmacy Director. Documentation and interview with the Pharmacy Director failed to reflect a remediation was completed for the actionable results on 10/2/14.

2a. Surface sampling: Review of the hospital Cancer Center Envirotest Log dated 12/9/14 noted that the pharmacy's anteroom surface testing results identified 40 Colony Forming Units (CFUs). Two weeks later (?12/23/14 on the same form), the CFUs were identified as gram positive cocci in pairs and clusters, but failed to identify the genus/species. The hospital's USP 797 Environmental Policy indicated that the CFU should be identified at least on the genus level. The Log failed to identify who prepared the samples and which surface areas were sampled. Additionally, The Envirotest Log dated 12/9/14 had omissions and discrepancies in the documentation. The Log failed to identify which of the hospital's pharmacies was sampled (main vs Cancer Center). The IV clean room and the anteroom were mislabeled on the Log. Interview with the Pharmacy Director on 1/15/15 and 1/16/15 indicated that the Log dated 12/9/14 was the Cancer Center Pharmacy's clean room and anteroom.

2b. Review of hospital documentation identified anteroom International Organization for Standardization (ISO) level discrepancies in the Cancer Center pharmacy. The hospital vendor's Monitoring Plan for Viable Particles documentation dated 9/25/13 indicated that the anteroom was ISO 7, however, the hospital vendor's Monitoring Plan for Viable Particles documentation dated 3/27/14 identified the level as ISO 8. Review of the hospital's USP 797 Environmental Policy indicated that the anteroom was designated ISO 7 and that the CFU count should be < 10, whereas, an ISO 8 level should be <100. The Policy also indicated that in the event that an environmental sample exceeded the threshold, an investigation and corrective procedures would be taken: The Environmental Monitoring Action Plan. The Plan directed staff re-education and thorough cleaning of all compounding space followed by a 5 consecutive day monitoring. Interview with Pharmacy Technician #1 on 1/15/14 indicated that he/she was unable to identify the communication process between the microbiology lab and pharmacy for obtaining the environmental testing results. Interview with the Microbiology Manager on 1/13/15 identified that the microbiology lab copies the log and sends the original log back to the pharmacy. The Microbiology Manager was not aware of any remedial action taken. The USP 797 Environmental Policy indicated that the sampling data would be collected and reviewed by the IV Room Supervisor with all positive results reported to the Pharmacy Director. Interview with the Pharmacy Director on 1/16/15 indicated that he/she was aware of the surface testing results on 12/9/14. Furthermore, the Policy indicated that any CFU count that exceeds its respective action level shall prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures and air filtration within the compounding area. Documentation and interviews failed to reflect if the CFU count was actionable and if proper remediation had been conducted.


2c. The hospital's USP 797 Environmental Policy indicated that periodic reports were to be made to the infection control committee. Review of hospital documentation and interviews with the Cancer Center Administrator, the Infection Preventionist on 1/15/15 and with the Cancer Center Medical Director on 1/16/15 identified that they were unaware of the testing results. The Infection Preventionist identified that he/she would expect the results to be given to the him/her and/or to the Infectious Disease Director. See A0049 and A0749.





3a. Review of facility documentation and interview with Nurse Manager (NM) #4 on 01/15/15 identified that on the afternoon of 12/24/14, water leaks were observed in three patient rooms on one of the two hallways of the telemetry unit. The Manager of Facilities Operations and the Assistant Director of Nursing (ADN) #1 were notified and the patients were moved to the unaffected hallway. Interview with the Director of Patient Care Services and ADN #1 on 01/13/15 at 4:10 PM identified that the leaking continued throughout the night and in addition to the patient rooms, the leak affected the clean utility rooms, the hallway in the entrance to the unit and the nursing station. Plastic tubing had been placed in the drains that extended into buckets positioned on the floor of the affected areas to prevent pooling of water. On 12/25/14, ADN #1 consulted with MD #10 (Hospitalist on duty) and MD #11 (Cardiologist on duty), and based on concerns for patient safety, the decision was made to relocate all patients from both sides of the telemetry unit to other units of the hospital until the water problem could be remediated. The patients were relocated to appropriate units on 12/25/14 without interruption in care and services.

A projected plan for water damage remediation and the relocation of patients on the telemetry unit was documented by the Assistant Chief Nursing Officer (ACNO) #1 and forwarded to Vice President (VP)/CEO, NM #4, ACNO #2/Director of Patient Care Services, Manager of Facility Operations, Director of Facilities, and Cardiologists and Physician Assistants (PA) on 12/26/14 at 4:56 PM. The plan included the clean-up and drying of the unit on 12/26, 12/27, and 12/28/14. Construction/replacement parts were to be delivered on 12/29/14, and repair work was expected to be completed on 12/30/14 followed by cleaning of unit. The unit was projected to reopen on 12/31/14.

Additional documentation by ACNO #1 dated 12/27/14 at 8:15 AM was distributed to Patient Care Services, the ADNs, ACNO #2, and NM #4. The documentation identified that the unit was still closed with hopes of completing the work, cleaning the unit, and reopening on 12/31/14. Between 12/27/14 and 12/31/14, the proposed management of new hospital admissions included to fill open beds on other units, open another unit (3.6) that had been closed which was cleaned and stocked.

On 12/28/14, ACNO #1 documented an update that was forwarded to ADNS #1, Manager of Facility Operations, Director of Material Management, Program Manager/Infection Prevention, ACNO #2, Director #1, VP/Chief Human Services Officer, and MD #1. The update identified that due to increasing patient admissions, "we" have reassessed the opening of a portion of the telemetry unit (5.4). ADNS #1 and the Manager of Facility Operations proposed to open the unaffected side of the unit within 4 hours, clean the main hallway, clean and restock the clean utility room, replace affected ceiling tiles, and clean the nursing station. In addition, wait to open unit 3.6 as reopening of a portion of 5.4 would be more beneficial (providing more open beds).

Interview with the Safety Manager on 01/14/14 at 10:50 AM identified that he/she was informed of the leak and the need for relocation of the patients from unit 5.4. He/she toured 5.4 on 12/26/14 and recommended ongoing monitoring for mold, particulate count for dust. Air Quality Consultant #1 was contacted and scheduled testing for 12/31/14. The Safety Manager identified that he/she had directed that unit 5.4 should remain patient free until 12/31/14. On 12/31/14 ceiling tiles had been replaced and hallway cleaning had been completed, however, drains and bucket collecting systems remained in the areas affected by the leaks. The Safety Manager identified that he/she was not consulted prior to patients being admitted to unit 5.4 on 12/28/14, was not aware of the unit reopening until 12/29/14, and was concerned that patients were admitted to unit 5.4 before the results of the air quality testings were received.

Review of an Indoor Air Quality and Environmental Fungi (mold) Evaluation identified that air samplings for environmental fungi were collected on 12/31/14 with microbial growth in the following areas: 13 cfu's/M3 in the hallway by room 5.440 and 40 cfu's/M3 in clean utility room 5.443. Low level counts of Aspergillus/Penicillium and Basidiospores were also detected.

Interview with the Manager of Facilities Operation on 01/16/15 at 1:00 PM identified that he/she was not involved with the decision to reopen unit 5.4 on 12/28/14. As of 12/26/14, the plan was to reopen the unit on 12/31/14. On 12/26/14, patient rooms with active leaks were closed and all wet materials including tiles were removed. Six tiles had also been removed in the nursing station and hallway. The Manager of Facilities Operation was notified by the ACNO on 12/28/14 that the unit needed to be opened within 4 hours. He/she replaced six ceiling tiles, which were cut at the nursing station. Remaining dust and debris was vacuumed, but surfaces were not wiped down. No work was completed in the affected resident rooms or the clean utility room.

Interview with the Director of Environmental Services on 1/15/15 at 12:20 PM identified that he/she had been informed of the leak on unit 5.4 on 12/25/14 and directed the Environmental Services staff to terminally clean all unaffected patient rooms. The cleaning was completed on 12/26/14. The Director of Environmental Services instructed the staff to clean all rooms and nursing station on 12/28/14 in preparation for the unit reopening and he/she toured the unit and inspected all the unaffected rooms. The rooms appeared clean and ready for occupancy. The affected rooms could not be cleaned and inspection identified that ceiling tiles were not in place and the doors were closed. Tacky mats had been placed on the threshold of each room. The Director of Environmental Services did not inspect the Nursing Station, however additional concerns regarding dust were brought to his/her attention on 12/29/14 and an additional housekeeper was added to the staffing to focus on cleaning the hallway and nursing station. The increased amount of dust was noted throughout the unit after the unit was reopened and occupied with patients.

Interview with the Program Manager/Infection Prevention Nurse on 01/14/15 at 3:00 PM identified that he/she was not notified of the water issue and/or relocation of patients on 12/24/2014 or 12/25/14 but would have expected to have been notified. He/she was notified on 12/26/14 and toured the unit, making recommendations for cleaning. He/she identified an area of mold like substance in the hallway. He/she communicated to the rest of the Infection Control staff that there was plenty of time for cleaning to be completed after all the repairs and remediation were finished as the unit was not projected to be reopened until 12/31/14. The Program Manager was notified on 12/28/14 that patients were to be readmitted to unit 5.4 within 4 hours but was not involved in the decision. He/she was not in the facility at the time but instructed the infection control staff to ensure that terminal cleaning had been performed and that equipment had been discarded and/or cleaned. All tasks had not been completed prior to patients being admitted to the unit. Additionally, he/she was not informed that an air quality study had been performed until the results were received on 01/12/15.

Interview with MD #3, the Chief of Medicine and Director of Infection Control, identified that he/she had not been consulted regarding the decision to readmit patients to unit 5.4.

Although patients were initially admitted to rooms on a hallway that was not directly affected by the water leaks, access to the hallway required passage through the affected hallway and past the affected rooms and nursing station. A doorway in the affected hallway remained open and remediation continued in the affected rooms allowing free circulation of air between the hallways. The clean utility room had not been remediated when the unit opened, requiring nursing staff to obtain needed supplies from other units. Additionally, tubing and buckets remained in the nursing station, hallway, and affected rooms until remediation was complete, creating a potential for standing water and increased moisture as well as tripping hazards in the unit environment.

3b. The surveyor, accompanied by the Director of Facilities, observed that the walls and ceilings throughout the 5.4 Cardiac Care Unit showed signs of roof leaks/water infiltration. An interview of staff revealed that there was a roof leak on December 24th, 2014 and fifteen (15) patients were relocated from this unit to other patient care areas within the facility. Patients were returned to the affected areas on December 27th 2014 prior to an indoor air quality test being conducted to ensure the safety to patients and occupants of the unit. An indoor air quality test was conducted on December 31st 2014 by an accredited lab contracted by the facility and the documented results were completed on January 12, 2015 and forwarded to the facility.

An interview conducted with the facility's Safety Manager and Engineering staff on January 13, 2015 revealed that the facility had no plan to continue indoor air quality monitoring in this space.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on a tour of the hospital Cancer Center Pharmacy, review of hospital documentation, review of hospital policies and interviews with hospital personnel, documentation and interviews failed to reflect that the pharmacy's air and surface testing results were reported to the hospital's infection control program.
In addition, the hospital failed to ensure that infection preventionists were consulted prior to returning patients to a unit of the hospital identified with significant environmental concerns, prior to completion of remediation and that remediation (replacement of wall boards and ceiling tiles) occurred while the unit was occupied with patients creating dust and other environmental concerns. The findings include:

1a. Air sampling: Review of the hospital environmental testing vendor documentation dated 10/2/14 identified air samples with actionable levels of fungus and yeast in the Cancer Center pharmacy's clean room and anteroom. The organisms of concern were Trichophyton (fungus) in the clean room buffer area and Rhodotorola (yeast) in the anteroom. Review of the hospital's USP 797 Environmental Policies and Procedures indicated that all logs and certification records would be maintained and reviewed by supervisory personnel or other designated employees to ensure controlled environments comply with proper air cleanliness. The Policy indicated that sampling data would be collected and reviewed by IV room supervisory personnel with all positive samples reported to the Pharmacy Director. Documentation and interview with the Pharmacy Director failed to reflect a remediation was completed for the actionable results on 10/2/14.

2a. Surface sampling: Review of the hospital Cancer Center Envirotest Log dated 12/9/14 noted that the pharmacy's anteroom surface testing results identified 40 Colony Forming Units (CFUs). Two weeks later (?12/23/14 on the same form), the CFUs were identified as gram positive cocci in pairs and clusters, but failed to identify the genus/species. The hospital's USP 797 Environmental Policy indicated that the CFU should be identified at least on the genus level. The Log failed to identify who prepared the samples and which surface areas were sampled. Additionally, The Envirotest Log dated 12/9/14 had omissions and discrepancies in the documentation. The Log failed to identify which of the hospital's pharmacies was sampled (main vs Cancer Center). The IV clean room and the anteroom were mislabeled on the Log. Interview with the Pharmacy Director on 1/15/15 and 1/16/15 indicated that the Log dated 12/9/14 was the Cancer Center Pharmacy's clean room and anteroom.
2b. Review of hospital documentation identified anteroom International Organization for Standardization (ISO) level discrepancies in the Cancer Center pharmacy. The hospital vendor's Monitoring Plan for Viable Particles documentation dated 9/25/13 indicated that the anteroom was ISO 7, however, the hospital vendor's Monitoring Plan for Viable Particles documentation dated 3/27/14 identified the level as ISO 8. Review of the hospital's USP 797 Environmental Policy indicated that the anteroom was designated ISO 7 and that the CFU count should be < 10, whereas, an ISO 8 level should be <100. The Policy also indicated that in the event that an environmental sample exceeded the threshold, an investigation and corrective procedures would be taken: The Environmental Monitoring Action Plan. The Plan directed staff re-education and thorough cleaning of all compounding space followed by a 5 consecutive day monitoring. Interview with Pharmacy Technician #1 on 1/15/14 indicated that he/she was unable to identify the communication process between the microbiology lab and pharmacy for obtaining the environmental testing results. Interview with the Microbiology Manager on 1/13/15 identified that the microbiology lab copies the log and sends the original log back to the pharmacy. The Microbiology Manager was not aware of any remedial action taken. The USP 797 Environmental Policy indicated that the sampling data would be collected and reviewed by the IV Room Supervisor with all positive results reported to the Pharmacy Director. Interview with the Pharmacy Director on 1/16/15 indicated that he/she was aware of the surface testing results on 12/9/14. Furthermore, the Policy indicated that any CFU count that exceeds its respective action level shall prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures and air filtration within the compounding area. Documentation and interviews failed to reflect if the CFU count was actionable and if proper remediation had been conducted.

2c. The hospital's USP 797 Environmental Policy indicated that periodic reports were to be made to the infection control committee. Review of hospital documentation and interviews with the Cancer Center Administrator, the Infection Preventionist on 1/15/15 and with the Cancer Center Medical Director on 1/16/15 identified that they were unaware of the testing results. The Infection Preventionist identified that he/she would expect the results to be given to the him/her and/or to the Infectious Disease Director. See A0049 and A0491.



3a. Review of facility documentation and interview with Nurse Manager (NM) #4 on 01/15/15 identified that on the afternoon of 12/24/14, water leaks were observed in three patient rooms on one of the two hallways of the telemetry unit. The Manager of Facilities Operations and the Assistant Director of Nursing (ADN) #1 were notified and the patients were moved to the unaffected hallway. Interview with the Director of Patient Care Services and ADN #1 on 01/13/15 at 4:10 PM identified that the leaking continued throughout the night and in addition to the patient rooms, the leak affected the clean utility rooms, the hallway in the entrance to the unit and the nursing station. Plastic tubing had been placed in the drains that extended into buckets positioned on the floor of the affected areas to prevent pooling of water. On 12/25/14, ADN #1 consulted with MD #10 (Hospitalist on duty) and MD #11 (Cardiologist on duty), and based on concerns for patient safety, the decision was made to relocate all patients from both sides of the telemetry unit to other units of the hospital until the water problem could be remediated. The patients were relocated to appropriate units on 12/25/14 without interruption in care and services.

A projected plan for water damage remediation and the relocation of patients on the telemetry unit was documented by the Assistant Chief Nursing Officer (ACNO) #1 and forwarded to Vice President (VP)/CEO, NM #4, ACNO #2/Director of Patient Care Services, Manager of Facility Operations, Director of Facilities, and Cardiologists and Physician Assistants (PA) on 12/26/14 at 4:56 PM. The plan included the clean-up and drying of the unit on 12/26, 12/27, and 12/28/14. Construction/replacement parts were to be delivered on 12/29/14, and repair work was expected to be completed on 12/30/14 followed by cleaning of unit. The unit was projected to reopen on 12/31/14.

Additional documentation by ACNO #1 dated 12/27/14 at 8:15 AM was distributed to Patient Care Services, the ADNs, ACNO #2, and NM #4. The documentation identified that the unit was still closed with hopes of completing the work, cleaning the unit, and reopening on 12/31/14. Between 12/27/14 and 12/31/14, the proposed management of new hospital admissions included to fill open beds on other units, open another unit (3.6) that had been closed which was cleaned and stocked.

On 12/28/14, ACNO #1 documented an update that was forwarded to ADNS #1, Manager of Facility Operations, Director of Material Management, Program Manager/Infection Prevention, ACNO #2, Director #1, VP/Chief Human Services Officer, and MD #1. The update identified that due to increasing patient admissions, " we " have reassessed the opening of a portion of the telemetry unit (5.4). ADNS #1 and the Manager of Facility Operations proposed to open the unaffected side of the unit within 4 hours, clean the main hallway, clean and restock the clean utility room, replace affected ceiling tiles, and clean the nursing station. In addition, wait to open unit 3.6 as reopening of a portion of 5.4 would be more beneficial (providing more open beds).

Interview with the Safety Manager on 01/14/14 at 10:50 AM identified that he/she was informed of the leak and the need for relocation of the patients from unit 5.4. He/she toured 5.4 on 12/26/14 and recommended ongoing monitoring for mold, particulate count for dust. Air Quality Consultant #1 was contacted and scheduled testing for 12/31/14. The Safety Manager identified that he/she had directed that unit 5.4 should remain patient free until 12/31/14. On 12/31/14 ceiling tiles had been replaced and hallway cleaning had been completed, however, drains and bucket collecting systems remained in the areas affected by the leaks. The Safety Manager identified that he/she was not consulted prior to patients being admitted to unit 5.4 on 12/28/14, was not aware of the unit reopening until 12/29/14, and was concerned that patients were admitted to unit 5.4 before the results of the air quality testings were received.

Review of an Indoor Air Quality and Environmental Fungi (mold) Evaluation identified that air samplings for environmental fungi were collected on 12/31/14 with microbial growth in the following areas: 13 cfu ' s/M3 in the hallway by room 5.440 and 40 cfu ' s/M3 in clean utility room 5.443. Low level counts of Aspergillus/Penicillium and Basidiospores were also detected.

Interview with the Manager of Facilities Operation on 01/16/15 at 1:00 PM identified that he/she was not involved with the decision to reopen unit 5.4 on 12/28/14. As of 12/26/14, the plan was to reopen the unit on 12/31/14. On 12/26/14, patient rooms with active leaks were closed and all wet materials including tiles were removed. Six tiles had also been removed in the nursing station and hallway. The Manager of Facilities Operation was notified by the ACNO on 12/28/14 that the unit needed to be opened within 4 hours. He/she replaced six ceiling tiles, which were cut at the nursing station. Remaining dust and debris was vacuumed, but surfaces were not wiped down. No work was completed in the affected resident rooms or the clean utility room.

Interview with the Director of Environmental Services on 1/15/15 at 12:20 PM identified that he/she had been informed of the leak on unit 5.4 on 12/25/14 and directed the Environmental Services staff to terminally clean all unaffected patient rooms. The cleaning was completed on 12/26/14. The Director of Environmental Services instructed the staff to clean all rooms and nursing station on 12/28/14 in preparation for the unit reopening and he/she toured the unit and inspected all the unaffected rooms. The rooms appeared clean and ready for occupancy. The affected rooms could not be cleaned and inspection identified that ceiling tiles were not in place and the doors were closed. Tacky mats had been placed on the threshold of each room. The Director of Environmental Services did not inspect the Nursing Station, however additional concerns regarding dust were brought to his/her attention on 12/29/14 and an additional housekeeper was added to the staffing to focus on cleaning the hallway and nursing station. The increased amount of dust was noted throughout the unit after the unit was reopened and occupied with patients.

Interview with the Program Manager/Infection Prevention Nurse on 01/14/15 at 3:00 PM identified that he/she was not notified of the water issue and/or relocation of patients on 12/24/2014 or 12/25/14 but would have expected to have been notified. He/she was notified on 12/26/14 and toured the unit, making recommendations for cleaning. He/she identified an area of mold like substance in the hallway. He/she communicated to the rest of the Infection Control staff that there was plenty of time for cleaning to be completed after all the repairs and remediation were finished as the unit was not projected to be reopened until 12/31/14. The Program Manager was notified on 12/28/14 that patients were to be readmitted to unit 5.4 within 4 hours but was not involved in the decision. He/she was not in the facility at the time but instructed the infection control staff to ensure that terminal cleaning had been performed and that equipment had been discarded and/or cleaned. All tasks had not been completed prior to patients being admitted to the unit. Additionally, he/she was not informed that an air quality study had been performed until the results were received on 01/12/15.

Interview with MD #3, the Chief of Medicine and Director of Infection Control, identified that he/she had not been consulted regarding the decision to readmit patients to unit 5.4.

Although patients were initially admitted to rooms on a hallway that was not directly affected by the water leaks, access to the hallway required passage through the affected hallway and past the affected rooms and nursing station. A doorway in the affected hallway remained open and remediation continued in the affected rooms allowing free circulation of air between the hallways. The clean utility room had not been remediated when the unit opened, requiring nursing staff to obtain needed supplies from other units. Additionally, tubing and buckets remained in the nursing station, hallway, and affected rooms until remediation was complete, creating a potential for standing water and increased moisture as well as tripping hazards in the unit environment.

3b. The surveyor, accompanied by the Director of Facilities, observed that the walls and ceilings throughout the 5.4 Cardiac Care Unit showed signs of roof leaks/water infiltration. An interview of staff revealed that there was a roof leak on December 24th, 2014 and fifteen (15) patients were relocated from this unit to other patient care areas within the facility. Patients were returned to the affected areas on December 27th 2014 prior to an indoor air quality test being conducted to ensure the safety to patients and occupants of the unit. An indoor air quality test was conducted on December 31st 2014 by an accredited lab contracted by the facility and the documented results were completed on January 12, 2015 and forwarded to the facility.

An interview conducted with the facility's Safety Manager and Engineering staff on January 13, 2015 revealed that the facility had no plan to continue indoor air quality monitoring in this space.