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Based on observation, interview and document review the facility failed to ensure staff processing re-usable semi-critical and critical devices followed manufacturer's directions for use to verify efficacy of the cleaning and disinfecting processes.

Failure to properly test the efficacy of manual and automated disinfection processes puts patients at risk for infections and communicable diseases.

Item #1- Proper use of chemical monitoring strips

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Findings:

On 7/1/ 2014 at 10:35 AM, the investigator observed an open bottle of chemical indicator test strips used to determine the efficacy of the high-level disinfecting solution used for trans-vaginal ultrasound probes in the imaging department. The open date and 90-day expiration date was not marked on the outside of the bottle as directed by the manufacturer and per hospital policy.

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Item #2- Policy for care and use of the washer/disinfector

Findings:

1. On 7/1/2014 the investigator reviewed policy documents for sterile processing. There was no evidence of a policy for care or maintenance for the "Getinge Decomat 8666" Washer/disinfector, a machine that provides intermediate-level automated disinfection. The Chief Quality Officer (Staff Member #1) confirmed this finding.

2. American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) Standard 79:2010 "Comprehensive guide to steam sterilization and sterility assurance in health care facilities" section 7.5.3.3. states: Mechanical cleaning equipment should be tested upon installation, weekly (preferably daily), during routine use and after major repairs.

3. Getinge USA, the manufacturer of the "Getinge Decomat 8666" washer/disinfector used by the facility states "Standard Operating Procedure(SOP)/Work instruction requires our service technician to perform a test object surgical instrument (TOSI) wash test after any repair is made to the washer.

4. On 7/1/2014 at 10:00 AM,the investigator reviewed the TOSI test logs for the washer/disinfector. There were only 2 dates recorded on the sheet: 01/23/2014 and 6/11/2014. The investigator interviewed a Sterile Processing Technician(Staff Member #2) about frequency of machine testing. The staff member indicated s/he performed testing using the TOSI wash test periodically, "but not as often as they should". S/he stated s/he ran the test on 6/30/2014, but failed to record the result. Staff were unaware of manufacturer's specific requirements for efficacy testing.

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Based on observation, interview and record review the facility failed to ensure that sterile processing staff adhered to manufacturer's recommended practice for reprocessing semi-critical and critical items and failed to develop annual staff competencies that included evaluation of procedures for cleaning, disinfection and sterilization of semi-critical devices.
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Failure to maintain personnel competency and compliance with job-specific infection prevention practices puts patients and staff at risk of communicable disease and infection.

Findings:
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1. Samaritan Healthcare Policy #7143.011 (revised 06/08) states "Test strips are not to be used after ninety (90) days from opening the test strip container".

2. On 7/1/2014 at 10:35 AM, the investigator interviewed a sonographer (Staff Member #4), a technician who performs diagnostic ultrasound, about processing of trans-vaginal probes for diagnostic imaging. The investigator observed that the container of chemical test strips for Cidex (a high-level chemical disinfectant) did not have the open date and the 90-day expiration date recorded on the side of the bottle as required by the manufacturer and per facility policy. Upon interview, Staff Member #4 stated s/he thought the expiration date was the manufacturer's expiration date stamped on the front of the container, and was unaware that once opened, the test strips should only be used for 90 days.

3. On 7/2/2014, the investigator reviewed human resource files of 4 sterile processing technicians. Only one of four files indicated that the staff member had received any ongoing training in high-level disinfection (1999). 4 of 4 staff members had annual competency check lists that did not include an evaluation of processing technique for high-level disinfection of semi-critical items.









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