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Tag No.: A0747
Based on policy and procedure review, document review, medical record review, and staff interviews, it was determined the facility failed to identify, investigate and prevent the transmission of infections associated with potential environmental sources as identified by the following:
1. Failed to identify, investigate, and control potential environmental sources of patient hospital acquired infections (HAI's).
2. Failed to identify and perform testing on the most likely sources of patient hospital acquired infections (HAI's), which included; construction, portable A/C units, and an improperly operating ventilation system.
3. Failed to ensure compliance with Infection Control Risk Assessment (ICRA) permit requirements for prevention of hospital acquired patient infections.
4. Failed to report ongoing patient hospital acquired fungal pneumonia infections to the governing board (GB).
See A749
Tag No.: A0749
Based on policy and procedure review, document review, medical record review, and staff interviews, it was determined the facility failed investigate and prevent the transmission of infections associated with potential environmental sources.
Findings included:
On 07/02/18 at 9:05 A.M., a tour was conducted of the 4th floor hematology unit, accompanied by the Chief Nursing Officer (CNO). Observations of the unit revealed there were two portable air-conditioning (A/C) units located centrally on the unit around the nurse's station. Staff were interviewed regarding environmental conditions, including temperature and humidity. Staff stated that last summer and this summer it had been warm and patients had been complaining. Both staff Registered Nurses (RN A, RN B) stated the portable AC units have been in place since the beginning of June 2018. RN A and RN B both stated the patient rooms stay warmer because they must keep their doors closed because of neutropenia (WBC count less than 1,000, normal 4,500-11,000), placing them at extremely high risk for infections. At the time of the tour, 22 of 24 patients were on neutropenic precautions. RN A and RN B both stated they provide the patients with portable fans and sometimes the patients require two portable fans. Both RN A and RN B stated the facility's staff is responsible for cleaning the fans. Both RN A and RN B stated they have had to dump the water reservoir when the portable A/C units shut off. Both stated maintenance does come up and empty the water reservoirs periodically and when called.
On 07/02/18 at 10:18 A.M., an interview with the Director of Facilities revealed the facility placed the portable A/C units on 4 units, (4N, 4S, 5N, 5S) starting on 06/21/18, due to staff and patient complaints of the unit and rooms being hot and humid. A request of all portable A/C units and locations showed the portable A/C units were first deployed on 06/05/18 to the following units: 4 North (4N), 4 South (4S), 5 North (5N), and 5 South (5S). The Director stated the facility added additional portable units on 06/28/18 to manage the increase in summer temperature. Emails showed the additional four portable A/C units were added on 06/23/18, for a total of eight portable A/C units on the 4th and 5th floor-nursing units. The Director stated that he did not keep daily maintenance logs for the eight units, but he did have emails regarding emptying the water reservoir. The Director confirmed the portable A/C units did not have hepa-filters.
A review of the portable A/C units' manual showed they were Office Pro 18's. A review of the manufacturer instructions for daily maintenance showed the Office Pro 18 is equipped with a drain tank switch. When the drain tank accumulates approximately 4.0 gallons of condensate (water) in the drain tank, the drain tank switch sends a signal to the microprocessor and stops all operation of the unit. Continued review of the manual revealed the following requirements for maintenance:
Daily inspection & maintenance
1. Empty the Drain Tank
2. Clean the air filters once a week. If the unit is used in a dusty environment, more frequent cleaning may be required. A dirty air filter can reduce air output resulting in a decrease of the cooling capacity.
3. Remove the two air filters for filter cleaning. Remove dust from the element with a vacuum cleaner, or rinse in cold or lukewarm water.
4. If the element is extremely dirty, wash with a neutral detergent. After the element has been cleaned, rinse with clean running water, allow to dry and then reinstall.
In-Season Inspection & Maintenance
1. Check the prongs and surface of the power cord plug for dust and/or dirt. If dust and/or dirt are present, wipe off with a clean dry cloth.
2. Check the power cord, plug and prongs for damage or excess play.
3. Check the air filters and drain tank.
4. Clean the outside of the unit(s) with a damp cloth or mild nonabrasive cleaner.
Off-Season Inspection & Maintenance
1. Operate the unit in FAN ONLY mode for 8 hours. Note: Operation is necessary to dry out the inside of the unit.
2. Disconnect the power cord from the AC outlet.
3. Check the prongs and surface of the power cord plug for dust and/or dirt. If dust and/or dirt are present, wipe off with a clean dry cloth. Check the power cord, plug and prongs for damage or excess play.
5. Clean the air filters.
6. Empty all water from the drain tank.
A review of the emails related to maintenance of the portable A/C units for 2018 showed the following:
June 2, 2018 - 1st shift emptied all portable units per instructions. 2nd shift emptied all portable A/C unit condensate tanks in all the old familiar locations. 3rd shift emptied portable A/C condensate tanks.
June 3, 2018 - Empty all portable A/C units per instructions. There was no indication in the email if this was performed.
June 5, 2018 - Work Order was generated by 4th floor nurse indicating the portable A/C unit would not turn on. Facilities reset the breaker.
June 16, 2018 - All portable A/C units were emptied and turned back on.
June 23, 2018 - All portable A/C units were emptied and turned back on.
A review of all emails and work orders for the above dates, failed to reveal required daily maintenance was performed on the eight portable A/C units located on the 4N, 4S, 5N and 5S nursing units.
A review of all emails and work orders for the timeframe of August 24, 2017 - January 23, 2018, for the portable A/C units located on the 4th and 5th floor-nursing units, failed to reveal required daily maintenance was performed.
There was no further evidence provided indicating required daily maintenance and In-Season/Off-Season Inspection & Maintenance was performed on the eight portable A/C units for 2017 and 2018.
A follow up interview with the Director of Facilities was performed on 07/02/2018 at 1:30 P.M., which revealed the issues with the AC units on the 4th and 5th floor nursing units were first recognized about a year and half ago. He stated the A/C units were original equipment to the building and were at the end of their life cycle. The decision was made that the ventilation would increase from one AC unit to two AC units supplying these nursing units. The Director stated that 4N and 5N would be replaced first, then 4S and 5S in April 2019. The Director stated that the Governing Body (GB) was aware the units needed replacing, but replacement had to fall into fiscal cycles, so they were prioritized based on budget constraints. The Director stated that the facility had other issues that took priority over the ventilation system on the 4th and 5th floor-nursing units.
A review of the facility policy entitled, Neutropenia, #ADM-N004, effective 05/2017, showed the policy shall address care and transport of the patient, environmental controls, and education of the patient and his or her caregiver and family. The policy showed that neutropenia is an absolute neutrophil count below 1, 000 mm. The policy states patients with neutropenia should have doors closed and no fresh flowers in the patient's room.
A review of the facility Utility Management Plan, #EC 1.9, effective 05/2018, revealed the facility would ensure the following:
- Preventative maintenance, inspections, and testing of all applicable utility and utility support equipment and systems.
- Provide contingency plans for all applicable utility and utility support equipment and systems, and review annually.
- A utility Management Program for the Center will consist of a plan to provide operations reliability of all utilities and to ensure utilities and environmental support systems are returned to service with the least interruption possible.
- Systems or equipment affecting the safety of patients, team members and visitors will require immediate attending.
- The policy applies to the following critical systems at the Center ...heating, ventilation, and air conditioning (HVAC).
- The Board of Directors receives regular reports of the key issues and needs of the utility Management Program. The Board reviews the reports, and as appropriate communicates concerns about identified issues and regulatory compliance. The Board also authorized capital budget expenses as necessary, to replace, upgrade or purchase utility related equipment or systems.
- Vice President of Facilitates and Support Services receives regular reports and as appropriate, communicates key concerns about issues and regulatory compliance.
- Implementation of the program indicated reporting and review utility problems, failures, or user error that or may be a threat to the environment of care.
On 07/03/18 at 2:00 P.M., a tour of 4S revealed construction and demolition was taking place. A review of the infection control risk assessment (ICRA) permit attached the barrier, showed the following requirements; negative pressure within the construction site, suits and shoe covers required for all workers within the barrier. Two workers within the barrier were observed to not be wearing shoe covers. The area located between 4N and 4S nursing units was observed to have small pieces of sheetrock that had been tracked onto carpet. The Facilities Director confirmed that hepa-filters were not being used in the portable A/C units.
On 07/03/18 at 0845 A.M., an interview was conducted with a facility Infection Preventionist (IP). The IP stated that every Monday there is a meeting with the design and construction staff related to safety, security, and construction updates. The IP stated that facilities indicated the portable A/C units utilized hepa-filters. The IP was asked if there had been any patient infections related to environmental pathogens in 2017 and 2018. The IP stated there were no patient infections related to environmental pathogens. The IP stated she had raised concerns at multiple construction meetings related to the excess heat on the 4th and 5th floor-nursing units. A request to provide all hospital-acquired infections (HAI's) related to the environmental pathogen Aspergillus for 2017 and 2018, due to a poorly functioning HVAC system, improperly maintained portable A/C units and multiple construction projects within the facility.
On 07/03/18 at approximately 9:30 A.M., an interview with the Infection Control Committee Chairman/Infectious Disease (ID) Physician, revealed the facility has had confirmed pneumonia infections with the mold aspergillus. The ID physician stated the facility now tracks nodular mold pneumonia via catscan (CT), versus cultures, because it is more accurate. The ID physician stated they had a "blip" last summer with 11 hospital acquired nodular mold pneumonias. He stated the facility checked the ice machine on 4N for the presence of mold. The ID physician provided the surveyor with three published articles related to detection and treatment of pulmonary (lung) mold infections in cancer patients with neutropenia. The conclusion of the articles showed that serial chest high resolution computed tomographic (HRCT) scans of the chest are assistive in early detection and treatment of mold pneumonias. A comprehensive review of all hospital acquired nodular pneumonias from January 2017 through May 30, 2018, revealed 26 patients.
A review of the 2018 Infection Control Risk Assessment showed the facility IP's had identified the facility was at high-risk related to environmental issues, specifically, frequent construction and renovation ongoing throughout the Center.
A review of CDC Guidelines for Environmental Infection Control in Health-Care Facilitates (2003), showed Aspergillosis and other health-care acquired fungal diseases are known to be associated with dusty or moist environmental conditions. The guidelines list the following causative activities and sources of aspergillus: improperly functioning ventilation systems, air-filters, air-filters frames, and construction
On 07/03/18 at 1:30 P.M., an interview was conducted with the IP manager for the facility. The IP manager stated the facility had identified four hospital acquired mold pneumonias in May of 2017 and subsequently performed a one-time test on of the following: 4N showerhead, shower handle, showerhead pipe, and a sink faucet. A limited indoor environmental quality evaluation was performed on May 2, 2017 by a third party vendor for the presence of mold related spores. The testing was not performed over several hours, but rather a basic microbial air sampling at the time of the evaluation for screening purposes. The following areas were sampled: 3 west corridor, 3W room 3703, 4N rooms 417, 420 and 4N corridor. At the time of the microbial air sampling, the facility had four cases of patient hospital acquired mold pneumonia. After the date of testing, the facility incurred an additional 22 hospital acquired patient infections with nodular mold pneumonia. The IP manager stated there is no acceptable benchmark rate for hospital acquired Aspergillus/mold infections and the facility utilizes only historical data as a benchmark. There was no testing performed near the multiple constructions sites or within the poorly operating ventilation system. The facility did not perform any further microbial sampling since the initial testing performed on May 2, 2017.
A review of the Infection Control Committee report dated May 23, 2017, revealed a report was provided to the committee indicating the nursing unit 4N had seen an increased number, four cases, of nodular pneumonia. The report showed that most of the cases were in rooms 417-424. The report indicated that air particulate testing was performed, as well as additional cleaning. Cultures of the showerheads revealed no growth. There was no indication that the ice machines were cultured as per the report from the ID physician. The committee report showed that no further action was required. A review of the Infection Control Committee reports since May 23, 2017, failed to reveal a report was provided related to the additional 26 patient hospital acquired mold pneumonias that had been identified.
A review of the GB committee agenda dated 05/30/18 showed an Annual Infection Report was provided by the ID physician committee chair. Review of the report failed to reveal any discussion related to the 26 patient hospital acquired nodular mold pneumonia infections. Further review of the GB agenda revealed an Annual Environment of Care (EOC) report was presented. The report provided showed the performance metric for 2018 was to reduce the number of portable fans provided to patient care areas located on all floors. The report showed the metric is a representation of how the heating, ventilation, and air-condition (HVAC) system provides comfort cooling to the patients and staff. The documented fan usage showed the following: 2015-309, 2016-740 and 2017-982. The facility was unable to provide evidence the GB was made aware of the environmental conditions (heat and humidity), patient/staff complaints, use of portable A/C units used to supplement the ventilation system, or patient hospital acquired mold pneumonias.
On 07/03/18 at approximately 3:00 P.M., an interview with the facility legal counsel and RM designee, confirmed the above findings and that there were no GB meeting agendas or minutes where the status of the poorly functioning HVAC system and hospital acquired mold pneumonia infections were reported.