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Based on document review, interview, and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

CFR 482.42 Infection Control

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Based on observation and staff interview, it was determined that the facility failed to ensure that walls are maintained clean and sanitary in the central sterile processing department.

Findings include:

On 6/3/12, the wall perimeters surrounding the newly installed hand-wash sink stationed next to the manual reprocessing sinks of the decontamination room were noted to be soiled and unclean with unfinished wall surfaces.


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Repeat Deficiency

Based on observation, staff interview, and review of documentation on June 3, 2013, it was determined that the facility failed to ensure that an ongoing program designed to prevent, control, and investigate infections and communicable diseases was maintained.

Findings include:

1. The hospital failed to provide and maintain sanitary environment to avoid sources and transmission of infections and communicable diseases. Refer to Tag A-0701.

2. The facility failed to implement nationally recognized infection control guidelines. Refer to Tag A-0749.

A. Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure that the manufacturer's instructions and industry standards were followed for the hi-level disinfection of endoscopes in the Endoscopy Department and Immediate Use Steam Sterilization in the Operating Room.

Findings include:

Reference #1: The plan of correction submitted by the facility states, "Auditing of flexible GI endoscope processing conducted weekly. Completion date 11/19/12 and ongoing; Audit data will be reported monthly to the Operating Room, Infection control and Hospital Performance improvement Committees. Completion date 1/2013 and ongoing."

Repeat Deficiency

1. The Endoscopy QA audit data reported to the Infection Control and Hospital Performance Improvement Committees was requested from Staff #1 and Staff #9
at 2:00 PM. The Endoscopy QA audit data was not provided. At 2:40 PM, Staff #9 stated that he/she has not been reporting QA data for the Endoscopy Department.

2. Review of Performance Committee Minutes for January 2013 did not include Endoscopy QA audit data.

Reference #2: The plan of correction submitted by the facility states, "Flash sterilization policy [Immediate Use Policy] developed jointly with sterilization consultant and referred to the Infection Control Committee for review and approval. Completion date 11/20/12."

Reference #3: AAMI ST 79: 11.2.5 states, "Procedures for flash sterilization should be based on a documented quality process that measures objective performance criteria. This quality process should be developed in conjunction with the appropriate using departments and should be integrated into the overall quality process in the health care facility. Monitoring frequency will vary, depending on the quality improvement goals, on facility policy and procedures for the handling of untoward events, and on the type of performance measure."

Repeat Deficiency

1. A documented quality process to measure flash sterilization cycles in the OR did not provide necessary information adequate to determine the reasons for the flash sterilization being used. Ongoing auditing does not provide data to assess the effectiveness of the process and make ongoing improvements in performance. Objective performance criteria to enable performance improvement, such as insufficient time for complete sterilization processing, identification of sufficient instrument inventory, and dropped instruments were not reported with flash sterilization.

a. The Operating Room Report dated April 2013 lists the dates and items sterilized with Immediate Use Steam Sterilization (IUSS); including 4/16 grasper, 4/17 penile implant clamp, 4/18 wishinger rod, 4/26 Staff #15's instruments, 4/29 lap tray and 4/30 cayene hip instrument. The reason for the immediate use cycle was not reported with sterilization cycle documentation.

2. At 2:15 PM, Staff #9 stated that the item sterilized on 4/4/13 listed as "pacemaker instrument" on the sterilizer print out was a gelpi retractor. It was sterilized with an immediate use cycle (3 minutes at 135 degrees Celsius, 1 minute dry). The reason for the immediate use cycle was not reported with sterilization cycle documentation.

3. At 12:45 PM, Staff #9 stated that the item(s) sterilized on 4/26/13 listed as Staff #15's instruments were forceps, a needleholder and a Metz instrument belonging to and brought in by Staff #15, a vascular specialist. The reason for the immediate use cycle was not reported with sterilization cycle documentation.

4. At 1:00 PM, Staff #9 presented the new January 2013 and revised (May 2013) policy titled "Immediate Use Steam Sterilization (IUSS) (Flash) for Gravity Displacement Steam Sterilizer" in draft form and stated it has not yet been approved by the Infection Control Committee. Item 21. b viii. of the policy requires specific reasons for each item being sterilized with the Immediate Use cycle. Staff #9 stated that the "Immediate Use Steam Sterilization (IUSS) Gravity Displacement Log" referenced in the policy will be used to report reasons for each IUSS, but the Immediate Use Steam Sterilization (IUSS) (Flash) for Gravity Displacement Log has not yet been placed into use.

Reference #4: AAMI ST79:2010- 10.5.3.1 states, "All BIs [Biological Indicators] should be used in accordance with the BI manufacturer's instructions."

Repeat Deficiency

1. The Operating Room 3M Steam Sterilizer Record for biological indicator test results on April 26, 2013 did not provide the date or time when the BI test and control vials were placed into and taken out of the incubator for the final read or the operators initials as requested by the 3 M manufacturer's steam sterilizer record.

Reference #5: AAMI ST 79- 7.2.2 states that the device labeling should identify specific methods of cleaning and sterilization that have been validated by the manufacturer. The manufacturer's written IFU (instructions for use) should be kept on file and periodically reviewed for any updates. If there are no specific written IFUs in the labeling, then the manufacturer should be contacted directly to provide a documented method.

Reference #6: Facility policy (new January 2013 and revised May 2013) titled "Immediate Use Steam Sterilization (IUSS) (Flash) for Gravity Displacement Steam Sterilizer" states, "#6. Manufacturer's instructions for IUSS will be kept on file and readily accessible to OR staff."

1. At 2:15 PM, Staff #9 stated that the Manufacturers instructions for sterilization for the pacemaker instruments (gelpi retractor) processed on 4/4/13 on the IUSS cycle were not available in the Operating Room.

2. Staff #9 stated that the Operating Room did not have the Manufacturer's instructions for use for Staff #15's instruments processed on 4/26 and the instruments are of the age and type that the brand or manufacturer could not be determined.

Reference #7: Facility policy titled "Immediate Use Steam Sterilization (IUSS) (Flash) for Gravity Displacement Steam Sterilizer" effective date January 2013, states in Section II- Purpose: "To define the use of immediate use steam sterilization (IUSS) and how to perform it correctly."

1. The Procedure in the above referenced policy describes the use of a Riley Flash Pak items #7-19 as the only container system used for IUSS. The use of an open pan is not addressed.

a. At 12:20 PM, Staff #9 stated that the Riley Flash Pak was not yet placed into use in the Operating Room. Staff #9 stated that an open pan is used for all immediate use steam sterilization cycles in the Operating Room at this time.

b. An open pan was observed inside of the sterilizer in substerile Room 2/3.












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B. Based on observation and document review, it was determined that the facility failed to ensure that a sanitary environment, to avoid sources and transmission of infections and communicable diseases was provided.

Findings include:

Reference #1: AAMI ST41 section 11 on Environmental and employee monitoring states, "To ensure a safe work environment and to establish compliance with federally mandated limits and voluntary guidelines on occupational exposure to EO [Ethylene Oxide], actual EO concentrations must be measured in the workplace during and after the use of sterilization equipment."

Reference #2: Facility policy titled "Ethylene Oxide(ETO) Sterilization Protocols" states, "Employee Safety: Employee badge monitoring for ETO levels is performed quarterly. a) January and September - 8 hours TWA. Employee should place badge as close to nose/month area as possible, wear for the entire shift when using ETO equipment, and label badge 8 hour TWA.
b) March and December - 15 minute STEL(measures exposure during a 15 minute period). Employee should place badge as close to nose/mouth area as possible, and wear the badge for a 15 minute period while performing any of the following activities: loading ETO sterilizer, unloading ETO sterilizer, and or handling ETO cartridge/placement inside cartridge holder. Label badge 15 minutes STEL. C) Results of ETO monitoring are reviewed with the employee upon receipt. Original copy is sent to Safety Officer, and a copy is sent to Employee Health for the employee's health record. Copy also is retained in department."

Repeat Deficiency

1. On 6/3/13, the badge air monitoring test results were obtained for Staff #11 and Staff #12, both who are involved in ETO sterilization.

a. Staff #11 had only performed one 8 hour TWA air monitoring badge testing on 10/23/13 and Staff #12 had only performed one 6 hour TWA air monitoring badge testing on 5/6/13.

b. Staff #10 stated that he/she was unfamiliar with facility's policy on the frequent badge monitoring testing for ETO.








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