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Based on observation, facility document review, and staff interview, it was determined that the facility failed to ensure the implementation of the Plan of Correction (PoC) from the Federal Validation survey conducted on 1/7/19. The facility failed to collect and analyze data in a manner that monitored the effectiveness of the changes immediately implemented following the survey.

Findings include:

1. The PoC indicated written manufacturer's instructions for use (IFU), for devices, will be followed.

a. The PoC states, "the manager of sterile processing will monitor three (3) trays per week for three (3) months to observe for use of manufacturer instructions for use."

i. Review of the data provided by Staff #14 revealed that monitoring had not been conducted the week of 3/4/19.

ii. Upon interview, Staff #14 stated that the monitoring of this audit was 100% compliant.

iii. Review of the weekly audit tool for the week of 3/12/19, indicated that the manufacturer's instructions for use for sterilization cycles were checked, and correctly followed, for K-Wires.

iv. Upon interview on 4/4/19, Staff #14 stated that all instruments, including K-Wires, were sterilized using a standard temperature of 275 degrees Fahrenheit, rather than following manufacturer's instructions for the devices.

v. Review of the manufacturer's instructions for use states, sterilize K-Wires at "270 degrees Fahrenheit."

b. The monitoring tool developed following the survey of 1/7/19, failed to identify the deficient practice continued.

c. The PoC states, "the manager of sterile processing educated staff in sterile processing ..."

i. Upon request, Staff #14 was unable to provide evidence of education provided for sterile processing staff.

2. The PoC, following an immediate jeopardy for the use of multidose containers accessed in an immediate patient care area for multiple patients, revealed the following:

a. The PoC states, "an appointed internal Auditor completed an internal audit of at least 30 patients over a two-month period since the end of the survey. ...Audits are now complete. We are at 100% compliance. Results were forwarded ... and will be reported at the next Quality Management Committee in March 2019."

i. Upon review of an internal audit, only twenty-three (23) audits were conducted.

ii. Quality Management Committee meeting minutes, dated March 25, 2019, were reviewed. There was no evidence of the findings from the monitoring of opened multi-dose containers in an immediate patient care area, addressed in the meeting minutes.

3. The above findings were confirmed by Staff #3 and Staff #11.