HospitalInspections.org

Cross refer to:

A0057

Based on a review of documentation and interviews with staff, the governing body failed to appoint a chief executive officer responsible for managing the hospital. Failure to manage the hospital and adhere to the facility's policies and procedures resulted in possible infectious exposure to 50 patients.

Findings were:

In an interview with staff #2, staff #2 was asked if he/she had any knowledge regarding a period of time where there was no documentation of the TV ultrasound probe receiving proper cleaning. Staff #2 stated that when he/she arrived at work on Monday, June 1st 2015, he/she was given a list of transvaginal procedures performed from 1-1-10 to 5-29-15 with instructions from staff #1 to use procedure data from the print-out to fill in the "Cidex OPA Solution Log" to account for all procedure dates missing in the log from the last cleaning date recorded to the first entry made by staff #2. Staff #2 stated that he/she was to fabricate dates for columns in the log for "date solution activated", "date solution expires", date test strips expire", "test results" (indicating the results of the test strips), "probe condition" and "tested by." A review of the print-out revealed that the print-out "user" was "HWMJJEFFER" and that the listing was printed on 5-29-15 (the previous Friday) at 11:41 (am/pm not indicated). The print-out contained columns denoting the procedure type, procedure date, patient name, patient number, ordering physician and technician. Staff #2 then directed this surveyor's attention to the "Cidex OPA Solution Log" and stated that the entry listing a test date of 1-3-14 was the last entry in the solution log when he/she began working at WMC on 3-9-15. Staff #2 stated that he/she did as instructed and filled in documentation of ultrasound cleaning for the missing procedures performed from 2-17-14 to 3-8-15, a total of 50 transvaginal ultrasounds.

In an interview with Staff #4, staff #4 stated that he/she had been employed with WMC since February 2005 and had been the Infection Control Manager since September or October 2005. Staff #4 stated that Infection Control meetings were held every 2 weeks and that the department heads from each department attended each meeting. He/she stated that the Quality Assurance director attends, also. Staff #4 stated, when asked, that data regarding infection control was provided to her throughout the month by each department, usually verbally. When asked how he/she would receive the information documented in the Cidex OPA solution log, staff #4 stated that he/she received that information verbally from staff #1. When asked if he/she had ever had any reason to believe that the data received was either false or fabricated, staff #4 stated that he/she had not.

Cidex® OPA label states, in part:
"INTENDED USE
High Level Disinfection
This solution may be used for the high level disinfection of heat-sensitive reusable semi-critical medical devices for which sterilization is not feasible.
...
Storage and Disposal
...
Do not reuse beyond 14 days or sooner as indicated by CIDEX OPA Solution test strips.
Once opened, the unused portion of the solution may be stored in the original container for up to 75 days until used."

GE Transducer Cleaning and Disinfection Guidelines state, in part:
"A validated high-level disinfection process combined with the use of a sterile gel and a transducer cover is an accepted method of infection control for ultrasound transducers. Adequate records or a logbook detailing the time, date, disinfection method and verification of disinfectant effectiveness or test results are recommended. For more information about establishing an evidence-based disinfection protocol for your practice, refer to the FDA, CDC, HICPAC, APIC or the Joint Commission Websites."

Facility policy 1000 US titled "Policy for Effective Use and Disposal of ortho-Phthaladehyde (OPA) Disinfectant" states, in part:
"Background and Rationale
A. High level disinfection with OPA requires immersion of the surfaces to be disinfected at room temperature for 12 minutes, which will assure killing of mycobacteria (TB).
D. OPA may be poured into a secondary container for use as a disinfectant soak. Once OPA has been used for disinfection it has as "use-life" of 14 days. Per the manufacturer OPA solution which has been used for disinfection must be discarded after 14 days.
E. Concentration of OPA must be tested daily before each use to ensure a minimum effective concentration (MEC) of 0.3%. Cidex® OPA solution test strips are used to determine adequate MEC. OPA must still be discarded after 14 days after the beginning of it's use-life even if the test strip shows an adequate MEC.
...
Procedure
H. Documentation
Record test results on the OPA testing log."

Facility policy 1002 titled "Transvaginal Ultrasonography - General Guidelines" states, in part:
"Procedure
· When the examination is complete remove the cover and clean the probe per the manufacturers instructions."

Facility Infection Control Plan states, in part:
"Risk Identification
· The Hospital at Westlake Medical Center infection control department will identify risks for the acquisition and transmission of infectious agents on an ongoing basis.
...
Specific goals include:
· To monitor the adherence of departmental polices (sic) ane results of the solution testing with procedures through regular environment of care and isolation rounds"

Failure to ensure that the solution was activated and not expired, that the test strips were
not expired, the results of the solution testing were within normal range and the condition
of the probe at the actual time that the probe was cleaned, could result in transmission of
infectious diseases between patients.

The above was verified in an interview with the facility Chief Nursing Officer, Chief Executive Officer, HR Director, Infection Control Manager and Operations Director on the afternoon of 6-9-15.

Cross refer to:
A0144

Based on a review of documentation and interviews with staff, the facility failed to protect the patients' right to care in a safe setting. Failure to do so potentially exposed 50 patients to infection.

Findings were:

In an interview with staff #2, staff #2 was asked if he/she had any knowledge regarding a period of time where there was no documentation of the TV ultrasound probe receiving proper cleaning. Staff #2 stated that when he/she arrived at work on Monday, June 1st 2015, he/she was given a list of transvaginal procedures performed from 1-1-10 to 5-29-15 with instructions from staff #1 to use procedure data from the print-out to fill in the "Cidex OPA Solution Log" to account for all procedure dates missing in the log from the last cleaning date recorded to the first entry made by staff #2. Staff #2 stated that he/she was to fabricate dates for columns in the log for "date solution activated", "date solution expires", date test strips expire", "test results" (indicating the results of the test strips), "probe condition" and "tested by." A review of the print-out revealed that the print-out "user" was "HWMJJEFFER" and that the listing was printed on 5-29-15 (the previous Friday) at 11:41 (am/pm not indicated). The print-out contained columns denoting the procedure type, procedure date, patient name, patient number, ordering physician and technician. Staff #2 then directed this surveyor's attention to the "Cidex OPA Solution Log" and stated that the entry listing a test date of 1-3-14 was the last entry in the solution log when he/she began working at WMC on 3-9-15. Staff #2 stated that he/she did as instructed and filled in documentation of ultrasound cleaning for the missing procedures performed from 2-17-14 to 3-8-15, a total of 50 transvaginal ultrasounds.

In an interview with Staff #4, staff #4 stated that he/she had been employed with WMC since February 2005 and had been the Infection Control Manager since September or October 2005. Staff #4 stated that Infection Control meetings were held every 2 weeks and that the department heads from each department attended each meeting. He/she stated that the Quality Assurance director attends, also. Staff #4 stated, when asked, that data regarding infection control was provided to her throughout the month by each department, usually verbally. When asked how he/she would receive the information documented in the Cidex OPA solution log, staff #4 stated that he/she received that information verbally from staff #1. When asked if he/she had ever had any reason to believe that the data received was either false or fabricated, staff #4 stated that he/she had not.

Cidex® OPA label states, in part:
"INTENDED USE
High Level Disinfection
This solution may be used for the high level disinfection of heat-sensitive reusable semi-critical medical devices for which sterilization is not feasible.
...
Storage and Disposal
...
Do not reuse beyond 14 days or sooner as indicated by CIDEX OPA Solution test strips.
Once opened, the unused portion of the solution may be stored in the original container for up to 75 days until used."

GE Transducer Cleaning and Disinfection Guidelines state, in part:
"A validated high-level disinfection process combined with the use of a sterile gel and a transducer cover is an accepted method of infection control for ultrasound transducers. Adequate records or a logbook detailing the time, date, disinfection method and verification of disinfectant effectiveness or test results are recommended. For more information about establishing an evidence-based disinfection protocol for your practice, refer to the FDA, CDC, HICPAC, APIC or the Joint Commission Websites."

Facility policy 1000 US titled "Policy for Effective Use and Disposal of ortho-Phthaladehyde (OPA) Disinfectant" states, in part:
"Background and Rationale
A. High level disinfection with OPA requires immersion of the surfaces to be disinfected at room temperature for 12 minutes, which will assure killing of mycobacteria (TB).
D. OPA may be poured into a secondary container for use as a disinfectant soak. Once OPA has been used for disinfection it has as "use-life" of 14 days. Per the manufacturer OPA solution which has been used for disinfection must be discarded after 14 days.
E. Concentration of OPA must be tested daily before each use to ensure a minimum effective concentration (MEC) of 0.3%. Cidex® OPA solution test strips are used to determine adequate MEC. OPA must still be discarded after 14 days after the beginning of it's use-life even if the test strip shows an adequate MEC.
...
Procedure
H. Documentation
Record test results on the OPA testing log."

Facility policy 1002 titled "Transvaginal Ultrasonography - General Guidelines" states, in part:
"Procedure
· When the examination is complete remove the cover and clean the probe per the manufacturers instructions."

Facility Infection Control Plan states, in part:
"Risk Identification
· The Hospital at Westlake Medical Center infection control department will identify risks for the acquisition and transmission of infectious agents on an ongoing basis.
...
Specific goals include:
· To monitor the adherence of departmental polices (sic) and procedures through regular environment of care and isolation rounds"

Failure to ensure that the solution was activated and not expired, that the test strips were
not expired, the results of the solution testing were within normal range and the condition
of the probe at the actual time that the probe was cleaned, could result in transmission of
infectious diseases between patients.


The above was verified in an interview with the facility Chief Nursing Officer, Chief Executive Officer, HR Director, Infection Control Manager and Operations Director on the afternoon of 6-9-15.

Cross refer to:

A0749

Based on a review of documentation and interviews with staff, the infection control officer failed to develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. Failure to do so exposed 50 patients to possible infection.
Findings were:

In an interview with staff #2, staff #2 was asked if he/she had any knowledge regarding a period of time where there was no documentation of the TV ultrasound probe receiving proper cleaning. Staff #2 stated that when he/she arrived at work on Monday, June 1st 2015, he/she was given a list of transvaginal procedures performed from 1-1-10 to 5-29-15 with instructions from staff #1 to use procedure data from the print-out to fill in the "Cidex OPA Solution Log" to account for all procedure dates missing in the log from the last cleaning date recorded to the first entry made by staff #2. Staff #2 stated that he/she was to fabricate dates for columns in the log for "date solution activated", "date solution expires", date test strips expire", "test results" (indicating the results of the test strips), "probe condition" and "tested by." A review of the print-out revealed that the print-out "user" was "HWMJJEFFER" and that the listing was printed on 5-29-15 (the previous Friday) at 11:41 (am/pm not indicated). The print-out contained columns denoting the procedure type, procedure date, patient name, patient number, ordering physician and technician. Staff #2 then directed this surveyor's attention to the "Cidex OPA Solution Log" and stated that the entry listing a test date of 1-3-14 was the last entry in the solution log when he/she began working at WMC on 3-9-15. Staff #2 stated that he/she did as instructed and filled in documentation of ultrasound cleaning for the missing procedures performed from 2-17-14 to 3-8-15, a total of 50 transvaginal ultrasounds.

In an interview with Staff #4, staff #4 stated that he/she had been employed with WMC since February 2005 and had been the Infection Control Manager since September or October 2005. Staff #4 stated that Infection Control meetings were held every 2 weeks and that the department heads from each department attended each meeting. He/she stated that the Quality Assurance director attends, also. Staff #4 stated, when asked, that data regarding infection control was provided to her throughout the month by each department, usually verbally. When asked how he/she would receive the information documented in the Cidex OPA solution log, staff #4 stated that he/she received that information verbally from staff #1. When asked if he/she had ever had any reason to believe that the data received was either false or fabricated, staff #4 stated that he/she had not.

Cidex® OPA label states, in part:
"INTENDED USE
High Level Disinfection
This solution may be used for the high level disinfection of heat-sensitive reusable semi-critical medical devices for which sterilization is not feasible.
...
Storage and Disposal
...
Do not reuse beyond 14 days or sooner as indicated by CIDEX OPA Solution test strips.
Once opened, the unused portion of the solution may be stored in the original container for up to 75 days until used."

GE Transducer Cleaning and Disinfection Guidelines state, in part:
"A validated high-level disinfection process combined with the use of a sterile gel and a transducer cover is an accepted method of infection control for ultrasound transducers. Adequate records or a logbook detailing the time, date, disinfection method and verification of disinfectant effectiveness or test results are recommended. For more information about establishing an evidence-based disinfection protocol for your practice, refer to the FDA, CDC, HICPAC, APIC or the Joint Commission Websites."

Facility policy 1000 US titled "Policy for Effective Use and Disposal of ortho-Phthaladehyde (OPA) Disinfectant" states, in part:
"Background and Rationale
A. High level disinfection with OPA requires immersion of the surfaces to be disinfected at room temperature for 12 minutes, which will assure killing of mycobacteria (TB).
D. OPA may be poured into a secondary container for use as a disinfectant soak. Once OPA has been used for disinfection it has as "use-life" of 14 days. Per the manufacturer OPA solution which has been used for disinfection must be discarded after 14 days.
E. Concentration of OPA must be tested daily before each use to ensure a minimum effective concentration (MEC) of 0.3%. Cidex® OPA solution test strips are used to determine adequate MEC. OPA must still be discarded after 14 days after the beginning of it's use-life even if the test strip shows an adequate MEC.
...
Procedure
H. Documentation
Record test results on the OPA testing log."

Facility policy 1002 titled "Transvaginal Ultrasonography - General Guidelines" states, in part:
"Procedure
· When the examination is complete remove the cover and clean the probe per the manufacturers instructions."

Facility Infection Control Plan states, in part:
"Risk Identification
· The Hospital at Westlake Medical Center infection control department will identify risks for the acquisition and transmission of infectious agents on an ongoing basis.
...
Specific goals include:
· To monitor the adherence of departmental polices (sic) and procedures through regular environment of care and isolation rounds"

Failure to ensure that the solution was activated and not expired, that the test strips were
not expired, the results of the solution testing were within normal range and the condition
of the probe at the actual time that the probe was cleaned, could result in transmission of
infectious diseases between patients.


The above was verified in an interview with the facility Chief Nursing Officer, Chief Executive Officer, HR Director, Infection Control Manager and Operations Director on the afternoon of 6-9-15.