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Based on observation, interview, record review, and policy review the facility failed to ensure there was an active infection control program for prevention and investigation to control infections and communicable diseases. The facility failed to:
-Have a qualified Infection Control Officer as demonstrated by experience, skills and knowledge for developing, implementing and maintaining an active infection control program;
-Ensure the Infection Control program included measures to prevent, control, and identify infections in patients, staff and visitors;
-Ensure healthcare-associated infections (HAI, infections acquired while in the facility) were investigated and analyzed for effectiveness including surveillance and monitoring in accordance with facility policies;
-Ensure the Infection Control Coordinator provided oversight for employee health as directed by the Infection Control Coordinator's job description; and
-Ensure leadership provided oversight that infection control activities were implemented and integrated in the hospital wide Quality Assessment Performance Improvement (QAPI) program. The facility's failure had the potential to affect all facility patients, staff, visitors, and the community. The facility census was 26.

The cumulative effect of the systemic failure resulted in non-compliance with 42 CFR 482.42 Condition of Participation: Infection Control.

Details of non-compliance with regulatory requirements are cited at A-0748, A-0749, and A-0756.

Based on interview and record review the facility failed to ensure the Infection Control Officer was qualified through education, training or experience. The facility census was 26.

Findings included:

1. Review of the job description for Staff L, the Infection Control Coordinator, showed the position is supervised by the Chief Executive Officer (CEO) and is responsible for the oversight of the Performance Improvement Program, Employee Health and Infection Control Program. The summary of responsibilities included the implementation of ongoing programs that objectively and systematically monitor and evaluate the quality and appropriateness of patient care through problems identified and implements resolutions.

The Minimum Requirements section showed that Infection Control Certification is required or will be obtained within three years. The job description did not designate the responsibility to develop and implement policies governing control of infections and communicable diseases in the facility.

2. Record review of the facility's policy titled, "Infection Surveillance", dated 02/10 showed that the Infection Control Coordinator is responsible for continuous total facility surveillance of infections and infection control measures based on the Centers for Disease Control guidelines (CDC). The policy showed the Infection Control Coordinator is responsible for no less than monthly data collection, data evaluation, and reporting of infection control data to appropriate committees, facility departments, and agencies.

3. Review of the personnel record for Staff L showed she began employment at the facility 03/12, had no employment history with nursing responsibility designated to infection control programs and no certification in infection control.

4. During an interview on 08/01/12 at approximately 10:55 AM, Staff L verified that she began employment at the facility 03/12, is not certified in Infection Control, has not had additional formal infection control education and that her previous infection control experience consisted of supervising an infection control coordinator five years ago. Staff L verified she is responsible for implementing the facility policy titled, "Infection Surveillance".

Based on observation, interview, record review, policy review and job description review, the facility failed to:
-Ensure the Infection Control program included measures to prevent, control, and identify infections in patients, staff and visitors;
- Ensure healthcare-associated infections (HAI, infections acquired while in the facility) were investigated and analyzed for effectiveness including surveillance and monitoring in accordance with facility policies;
-Ensure the Infection Control Coordinator provided oversight for employee health as directed by the Infection Control Coordinator's job description; and
-Ensure eight of eight ventilators were disinfected and ready for patient use.

The facility's failure to implement an active infection control program had the potential to affect all facility patients, staff, visitors and the community. The facility census was 26.

Findings included:

1. Review of the job description for Staff L, the Infection Control Coordinator, showed the position is supervised by the Chief Executive Officer (CEO) and is responsible for the oversight of the Performance Improvement Program and Employee Health and Infection Control Program. The summary of responsibilities include the implementation of ongoing programs that objectively and systematically monitor and evaluate the quality and appropriateness of patient care through problems identified and implements resolutions.

2. Record review of the facility's policy titled "Infection Control Committee" dated 01/12 showed the Infection Control Committee is responsible for providing guidance, leadership, instituting and maintaining measures for the identification, prevention, investigation, reporting and control of infection and communicable disease in the facility. Specific activities listed in the policy include:
-Tracking and reporting of communicable disease;
-Employee health and disease identification;
-Appropriate therapy of disease for the patient population;
-Education programs related to infectious disease control for employees, patients and visitors;
-Investigation of reports pertaining to exposures;
-Initiation of policies as needed and review of infection control policies and procedures not less than annually;
-Annual review of the Infection Control Prevention Plan, Infection Control Risk Assessment (a facility assessment of the known risks for infection), and annual analysis of the facilities HAI's;
-Report findings to the Performance Improvement Committee, Medical Executive Committee, Governing Board and others as appropriate.

Members of the Infection Control Committee included the Infection Control Coordinator (Chairman of the committee), Medical Chief of Staff, the Infectious Disease Physician, Director of Respiratory Therapy, the CEO, the Chief Nursing Officer and the Director of Pharmacy.

Record review of the facility's policy titled "Epidemiological Investigations" (the study of the spread of disease and disease origin) dated 02/10 showed the Infection Control Coordinator shall perform preliminary evaluation and use epidemiologic outbreak investigation principles to control, contain, or prevent the spread of disease among patients and healthcare workers when a two to two and a half (2 to 2 ?) percent increase in the infection rate of any size, any pathogen or combinations that occur. The policy also showed the detailed process and steps for conducting an outbreak investigation according to CDC (The Centers for Disease Control and Prevention) guidelines as well as the management of an exposure episode including the notification of the Medical Staff Executive Committee and Governing Body.

3. Review of the facility Infection Control Committee Meeting Minutes dated 04/18/12 showed January 2012 HAI data reported by Staff L, the Infection Control Coordinator. The data included:
-Catheter associated urinary tract infections (CAUTI) rate 5.1;
-Central line blood stream associated infections (CLABSI) rate 7.7;
-Methicillin-resistant staphylococcus aureus (MRSA, a type of bacteria that antibiotics cannot kill and can make people very sick) rate 1.2;
-Clostridium difficile (C-diff, a difficult to treat bacteria) rate 2; and
-Ventilator Associated Pneumonia (VAP, a bacterial lung infection acquired while a person's breathing is being assisted by a machine through a tube inserted into their trachea) rate 6.9;

The meeting minutes failed to show Staff L discussed any evaluation or follow-up investigation for infection rates as defined by facility policies "Infection Control Committee" and "Epidemiological Investigations".

4. During an interview on 08/01/12 at 10:55 AM, Staff L, Infection Control Coordinator, stated that the facility had no previous data available for comparison.

Since the facility had no previous data available for comparisons to determine if these infections should be investigated, the facility could have compared their data by using national benchmarks provided by the National Healthcare Safety Network, which is a surveillance system that integrates patient and healthcare personnel safety surveillance systems. There is no evidence the facility did compare their data with the national benchmarks.

Staff L, as chairman of the Infection Control Committee failed to ensure the committee acted on the HAI's in the facility as compared to the benchmark data.

5. Record review of the facility's policy "Cleaning, Disinfection & Sterilization of Patient Care Items" reviewed 02/10 showed: It is our policy to clean equipment to a reasonable degree of assurance that items are safe from pathogens and this definition of sanitizing: a process that results in a reduction in the microbial population on an inanimate object to a safe or relatively safe level.

6. During an interview on 07/30/12 at approximately 3:45 PM, Staff D, Respiratory Therapy Supervisor, stated that ventilator cleaning between patients is performed by respiratory therapists (RTs) and documented on the "Respiratory Therapy Vent Check-Out Flow Sheet" (check-out sheet) placed in a plastic page protector that is attached to each ventilator. The check-out sheet serves as a cumulative log for check-outs (set ups) of that ventilator and has a section titled "Vent Cleaned" for entering the date the ventilator was cleaned after its use on a patient, and the initials of the RT performing the cleaning. Staff D stated that he had initiated the use of the check-out sheet in the facility and there is no monitoring of this ventilator cleaning documentation.

Without monitoring this documentation, it is unknown if staff cleaned the ventilator set ups after use on patients and if the set ups are safe from pathogens. Cleaning cannot be confirmed by the RT setting up the ventilator for patient use if the date and RT initials are omitted from the "Vent Cleaned" section of the check-out sheet.

7. Observation on 07/30/12 at approximately 3:45 PM showed Staff D setting up a ventilator in a patient room in anticipation of a new patient admission. Review of the check-out sheet attached to the ventilator showed the "Vent Cleaned" section had no entry prior to this set up. Staff D acknowledged this omission and stated that he believed the ventilator had been cleaned because it had a plastic bag over it and had a new airway circuit (tubing system) attached to it.

8. During an interview on 07/31/12 at 1:30 PM, Staff O, RT, stated that ventilators are cleaned with sanitizing wipes (either non-bleach-containing wipes or bleach-containing wipes for use after a patient with C- difficile infection), a new airway circuit is applied, and the ventilator is covered with a plastic bag. Staff O stated that she believed the ventilators are cleaned properly but that cleaning cannot be confirmed by the RT setting up the ventilator for patient use if the date and RT initials are omitted from the "Vent Cleaned" section of the check-out sheet.

9. During an interview on 07/31/12 at 2:30 PM, Staff P, RT, stated that ventilators are cleaned with sanitizing wipes (she always uses bleach-containing wipes), a new airway circuit is applied, and the ventilator is covered with a plastic bag. Staff O stated that she believes the ventilators are cleaned properly but that cleaning cannot be confirmed by the RT setting up the ventilator for patient use if the date and RT initials are omitted from the "Vent Cleaned" section of the check-out sheet.

10. During an interview on 08/01/12 at 8:30 AM, Staff T, RT, stated that ventilators are cleaned with sanitizing wipes (either non-bleach-containing wipes or bleach-containing wipes for use after a patient with C- difficile infection), a new airway circuit is applied, and the ventilator is covered with a plastic bag. Staff O stated that she believes the ventilators are cleaned properly but that cleaning cannot be confirmed by the RT setting up the ventilator for patient use if the date and RT initials are omitted from the "Vent Cleaned" section of the check-out sheet.

11. Observation on 07/31/12 at approximately 9:30 AM of the check-out sheets attached to the ventilators on Patients #5 and #6 showed no entries in the "Vent Cleaned" section prior to the current set ups.

12. Record review of the cumulative check-out sheets attached to the six ventilators in use and two ready for use showed no entries in the "Vent Cleaned" section for 33 ventilator set ups.

It is unknown if staff cleaned the ventilator set ups after use on patients and are safe from pathogens. Cleaning cannot be confirmed by the RT setting up the ventilator for patient use if the date and RT initials are omitted from the "Vent Cleaned" section of the check-out sheet.

13. Review of the facility policy titled "Visitors and Infection Control" dated 01/12 showed the following direction: Important secondary educational measures for visitors to prevent transmission of infectious agents include screening and restricting visitors with signs of transmissible infections and that screening may be passive through the use of signs to alert family members and visitors with signs and symptoms of communicable diseases not to enter clinical areas.

14. During an interview on 08/01/12 at 10:20 AM, Staff L stated that she did not know the process to limit visitors with infections nor did she know if signs to alert visitors with infections were posted at facility entrances.

15. Observation on 08/01/12 at approximately 10:30 AM showed that there were no signs posted at facility entrances to alert visitors with symptoms of infection not to enter clinical areas.

16. During an interview on 08/02/12 at noon Staff BB, Chief of Staff and Infection Control Committee member, stated that all facility staff needs more education and training on infection control. Staff BB stated that he has witnessed inappropriate isolation signage used in patient care areas and staff going in and coming out of rooms without regard to isolation precautions. Staff BB stated that as a member of the Infection Control Committee he was not aware of the specific responsibilities of the Committee listed in the policy ("Infection Control Committee" policy.)

17. During an interview on 07/30/12 at approximately 1:30 PM, Staff L stated that her title is the Director of Quality Management and that she is also the Infection Control Coordinator. Staff L stated that the facility does not have an employee health nurse. Staff L verified that there was no person designated as the employee health nurse at the time of survey.

18. Record review of the facility's policy titled, "Elements of Employee Health Program", dated 12/09 showed multiple components of employee health evaluation including personnel health and job related illnesses and exposures. The policy showed the Infection Control Nurse will maintain records on all employee illness or job-related exposures, will work closely with all employees regarding transmissible illnesses and infections in personnel that require work restrictions or exclusions from work and will work with community public health agencies for reporting communicable diseases.

19. During an interview on 07/31/12 at 2:25 PM with Staff L, Director of Quality Management and Infection Control Coordinator, stated that CLABSI's, CAUTI's, VAP's, and C-diff rates are a problem. Staff L verified that no other tracking, trending or data base information from patient record reviews or infection control surveillance was available for analysis. Staff L verified she did no investigations of infection rates to identify problems. Staff L stated that in response to the high infection rates the only measures she has taken was that she posted a staff signup sheet to develop teams to work on the problems and for the high C-diff rates she told the housekeeping supervisor to tell her staff to use a bleach solution to clean everything. Staff L confirmed no hospital wide education or implementation of the change in disinfection procedures had been conducted.

20. During an interview on 08/01/12 at approximately 10:55 AM, Staff L verified that she did not provide the surveyors with documentation of ongoing active surveillance of infection indicators, investigation of any infection, data collection or analysis of HAI 's, monitoring of infections present upon admission, or controlling infections of patients, staff and visitors in the facility or communication with community health agencies. Staff L verified that the surveyors were not provided upon request a current Infection Control Plan, which identifies a system for identifying, reporting, investigating and controlling infections and communicable diseases in all areas of the facility. She verified that she does not monitor the implementation of policies and procedures in the facility which impact infection control. She verified that there are no hospital wide Quality Assurance and Performance Improvement measurements or activities for the infection control program. She verified she does not provide monitoring of laundry services, food services, dialysis services, water quality monitoring, or air flow quality, employee health, and/or visitors in the facility. She also stated that she does not develop, provide or monitor compliance with initial or ongoing infection control education for staff.

She verified that there is no 2012 Infection Control Risk Assessment (ICRA, an assessment of the risks and probability and possibility of infections occurring in the facility), no 2012 Infection Control Prevention Plan and no analysis of the 2011 Infection Control Prevention Plan or ICRA from the year of 2011.






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Based on record review and interview the Chief Executive Officer and the Medical Staff failed to:
-Ensure oversight and implementation of an active, effective facility wide infection control program and prompt response to identified problems related to healthcare-associated infections in the facility and
-Ensure the infection control program was integrated into the hospital wide Quality Assurance and Performance Improvement Program.

The CEO and Medical Staff is responsible for and provides critical and integral oversight of all facility operations. The failure to ensure the Infection Control Program was integrated into the Quality Assurance and Performance Improvement Program with ongoing competent oversight to ensure action to known infections and the implementation of measures to prevent infection affects all facility patients, staff, visitors and the community. The facility census was 26.

Findings included:

1. Review of the facility's 2012 Strategic Plan (an activity by an organization to define its' direction, challenges and opportunities and make decisions on allocating its resources to assess whether programs are meeting intended outcomes) showed the facility failed to identify goals for healthcare-associated infections (HAI, infections acquired while in the facility) for the year of 2011 and for the months of January and February 2012.

2. Review of the facility Infection Control Committee Meeting Minutes dated 04/18/12 showed January 2012 HAI data reported by Staff L, the Infection Control Coordinator. The reported data included:
-Catheter associated urinary tract infections (CAUTI) rate 5.1;
-Central line blood stream associated infections (CLABSI) rate 7.7;
-Methicillin-resistant staphylococcus aureus (MRSA, a type of bacteria that antibiotics cannot kill and can make people very sick) rate 1.2 ;
-Clostridium difficile (C-diff, a difficult to treat bacteria) rate 2; and
-Ventilator Associated Pneumonia (VAP, a bacterial lung infection acquired while a person's breathing is being assisted by a machine through a tube inserted into their trachea) rate 6.9;

The meeting minutes showed no discussion by the Committee, including Staff L, of any evaluation or follow-up investigation for infection rates as defined by the facility policies "Infection Control Committee" and "Epidemiological Investigations".

3. During an interview on 08/01/12 at 10:55 AM Staff L, Infection Control Coordinator, stated that the facility had no previous infection control data available for comparison.

The facility had no previous data available for comparison to determine if these infections should be investigated. Infection rate data is available for comparison using national benchmarks provided by the National Healthcare Safety Network, which is a surveillance system that integrates patient and healthcare personnel safety surveillance systems.

Staff L, as chairman of the Infection Control Committee failed to ensure the committee acted on the HAI's in the facility as compared to the benchmark data.

4. Review of the facility Performance Improvement Meeting Minutes dated 06/11/12 showed no Infection Control Committee Report.

5. Review of the facility Board of Managers Meeting Minutes dated 03/15/12 showed no reporting, discussion, follow up or planned action related to the HAI in the facility.

6. Review of the facility Medical Executive Committee Meeting Minutes dated 05/29/12 showed Staff L, the Infection Control Coordinator, reported the current facility HAI rates. The meeting minutes showed no response, no actions, no discussions or follow-up related to the facility's HAI rates reported. The Medical Executive Committee failed to address problems identified by the infection control coordinator.

7. During an interview on 08/02/12 at noon Staff BB, Chief of Staff and Infection Control Committee member stated that all facility staff needs more education and training on infection control. Staff BB stated that he has witnessed inappropriate isolation signs used in patient care areas and staff coming in and going out of rooms without regard to isolation precautions. Staff BB stated that as a member of the Infection Control Committee he was not aware of the specific responsibilities of the Committee members listed in the policy ("Infection Control Committee" policy).

8. During an interview on 08/01/12 at approximately 10:55 AM, Staff L verified that there are no hospital wide Quality Assurance and Performance Improvement measurements or activities for the infection control program. Staff L verified that she did not provide the surveyors with documentation of ongoing active surveillance, identification, investigation, monitoring, or controlling infections of patients, staff and visitors in the facility. Staff L verified that the surveyors were not provided upon request a current Infection Control Plan which identifies a system for identifying, reporting, investigation and controlling infections and communicable diseases in all areas of the facility ensuring early identification and response. She verified that she does not monitor the implementation of policies and procedures in the facility which impact infection control. She verified she does not approve or collaborate with the environmental services on the use of disinfectants or cleaning procedures in the facility, does not provide monitoring of laundry services, food services, dialysis services, water quality monitoring, or air flow quality, employee health, and visitors in facility. She also stated that she does not develop, provide or monitor compliance with initial or ongoing infection control education for staff including hand hygiene. She verified that there is no 2012 Infection Control Risk Assessment (ICRA, an assessment of the risks and probability and possibility of infections occurring in the facility), no 2012 Infection Control Plan and no analysis of the 2011 Infection Control Program Plan or ICRA from the year of 2011.

9. During an interview on 08/01/12 at 4 PM, Staff Y, the CEO stated that he expected Staff L, Infection Control Coordinator to implement all facility policies. Staff Y stated that he expected that all areas of the facility be represented in Quality Assurance and Performance Improvement and that he was unaware of any problems with the infection control program. He stated that he was surprised and shocked that Staff L, the Infection Control Coordinator had not been implementing the infection control policies.