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Tag No.: A0749
30172
Based on record reviews,observations and interviews, the hospital failed to maintain a sanitary environment to avoid and/or identify potential sources and transmission of infections and/or mitigate potential infection control risks as evidenced by:
- sterile supplies being stored on open shelving racks in hallways and/or near surgical scrub sinks and sterile supplies being stored in the O.R. (Operating Room) suites in open cabinets in the surgical areas,
- surgical scrub sinks being located within the semi-restricted areas in the surgical areas with no identification/mitigation of the infection control risk,
- sterile surgical supplies for the perfusion machines, used in cardiac heart surgery, being set up in advance with opened sterile supplies in a sub-sterile room days before a cardiac heart procedure was to be performed in the cardiac heart surgical suite.
Findings:
A review of the AORN (Association of periOperative Registered Nurses) Guidelines for Perioperative Practice, 2015 edition- Guideline for Packaging Systems: Recommendation III revealed in part: Sterilized items should be considered sterile until an event occurs to compromise the sterility of the sterile item such as, moisture penetration or unacceptable storage conditions, compression, exposure to airborne and other environmental contaminants and properties of the packaging material. The sterility of sterile items is event related and not time related. The sterility of an item does not change with the passage of time, but may be affected by particular events (such as, amount of handling, traffic) or environmental conditions (such as humidity, dust).
A review of AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Sterilization: Recommendation XV revealed in part: Sterilized items should have limited exposure to moisture and humidity to decrease the potential contamination of the sterilized items. Factors that contribute to contamination include air movement, humidity, temperature, location of storage, presence of vermin, whether shelving is open or closed, and properties of the packaging material. Sterile packages should be stored under environmental controlled conditions. Sterile items should not be stored under sinks or in other locations where they can become wet.
The AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Surgical Attire: Recommendation IX revealed in part: Restricted areas in a surgical suite, the O.R. (to include non-traditional O.R. settings, such as, Interventional Radiology suites, Labor and Delivery rooms and Procedure rooms) includes the clean core and the scrub sink areas. People in the restricted areas are required to wear full surgical attire (scrub attire, head coverings, masks, and shoe covers as applicable). The Semi-Restricted areas include the peripheral support areas of the surgical suite, the storage areas, the work areas, and corridors leading to the restricted areas of the surgical suite.
A review of the AORN Guidelines for Perioperative Practice, 2015 edition - Guideline for Sterile Technique - Recommendation V revealed in part: The sterile field, to include sterile equipment set up, should be prepared in the location where it will be used and should not be moved. Moving the sterile field/sterile equipment from one location to another increases the potential for contamination. The sterile field/sterile equipment should be prepared as close as possible to the time of use. The potential for bacterial growth and contamination increases with time because dust and other particles present in the ambient environment settle on horizontal surfaces. Particulate matter can be stirred up by personnel movement and can settle on open sterile supplies and the sterile field/sterile equipment is subject to unrecognized contamination by personnel, vectors, or breaks in sterile technique when left unattended. The sterility of an open sterile item is event related.
Observations on 02/12/16 from 12:30 p.m. to 3:30 p.m. with SF2DirOR, SF6RN/OR, and SF7RN/OR were made of all the surgical suite restricted and semi-restricted areas, to include all surgical scrub sink areas. Observations revealed multiple sterile supplies being stored on multiple opened metal shelving racks (ranging from 2 feet to 5 feet wide and 5 -6 feet in height and containing 5-6 shelves each) in the hallways in the restricted and semi-restricted surgical areas with some shelving racks being located near surgical scrub sinks. Observations of the surgical scrub sinks being located within the semi-restricted areas in the surgical areas with no identifiable delineation between the scrub sinks (restricted area) and the semi-restricted area. Further observations revealed observations of various O.R. staff (nurses, surgical technicians, physicians, and housekeepers) in these areas performing and conducting various O.R. tasks to include patients being transported to the O.R. suites. Observations of the peel packed sterile supplies on the shelving racks revealed many peel packed items that were being compressed by heavier sterile items and several peel packed items that were tightly packed into the various bin containers. Observations of the O.R.s revealed opened storage cabinets in the rooms where surgical procedures were conducted. A further observation of the sub-sterile room by the cardiac heart O.R. suite revealed 2 (two) perfusion open heart pump machines that were set up in advance with opened sterile supplies in the sub-sterile room where no open heart procedures had been performed in the cardiac heart surgical suite that day.
In an interview on 02/12/16 at 4:00 p.m. with SF2DirOR she indicated that some of the surgical scrub sinks used daily by the surgical team to perform surgical hand scrubs were located in the semi-restricted areas of the O.R. suite. She further indicated that some of the areas where the surgical scrub sinks and metal shelving racks (containing the sterile supplies)were located were also in areas where patients on stretchers were transported to the surgical O.R. suites and where non-surgical personnel, as necessary, would enter into the surgical suite areas. SF2DirOR indicated that staff were required to wear surgical attire in these semi-restricted area to include scrub clothes and head coverings, but not surgical masks. She indicated that surgical masks were not required in these areas unless you entered into the O.R. suite itself or you were performing a surgical hand scrub at the scrub sinks. SF2DirOR indicated the surgical scrub sinks in the semi-restricted areas did not have a delineated/marked area to designate those surgical scrub sinks areas as a restricted area within a semi-restricted area. SF2DirOR indicated that an infection control risk assessment for the surgical scrub sinks in the semi-restricted areas and an infection control risk assessment for the storage of sterile supplies in the O.R. hallways and in open O.R. cabinets did not assess these areas or identify these issues for potential infection control risks. SF2DirOR indicated that she knew the surgical area had a storage problem and the hospital had future plans developed that included the addressing of the hospital storage issues. SF2DirOR indicated that she was not aware that potential infection control risks that could not be resolved in a timely manner should be mitigated.
In an interview on 02/12/16 at 4:00 p.m. with SF2DirOR and SF7RN/OR (cardiovascular team leader) he was asked about the perfusion pumps that were set-up in advance with sterile supplies in the sub-sterile room. SF7RN/OR indicated that the perfusionists were told once before not to pre-set up the perfusion pumps with the sterile supplies in advance. SF2DirOR indicated that the last open heart procedure was performed on 02/11/16 and further indicated that the perfusion contract was just renewed. SF2DirOR indicated that the perioperative surgical departments followed the AORN Guidelines.
Observations on 02/15/16 were made of the non-traditional O.R. areas (Interventional Radiology Department, the Labor and Delivery Department and the Endoscopy Department) with SF12RN/Cath, SF13DirL&D, and SF14Endo and revealed open sterile supply storage areas being located in hallways and in suites where patient's invasive procedures were performed each day. The observation further revealed surgical scrub sinks in a non-delineated semi-restricted area in the Interventional Radiology Department. SF12RN/Cath, SF13DirL&D, and SF14Endo indicated that an infection control risk assessment risk in their respective areas did not identify these infection control issues and risks. SF12RN/Cath, SF13DirL&D, and SF14Endo further indicated that their respective areas also had storage problems. They indicated that they were not aware that potential infection control risks that could not be resolved in a timely manner should be mitigated.
In an interview on 02/15/16 at 12:30 p.m. with SF10IC, she indicated that she was the Infection Control Officer. SF10IC indicated that the Infection Control Program did not identify the above infection control issues and risks during any of the infection control risks assessments performed by the Infection Control Department. She indicated that no Infection Control Risk Assessment was performed since the last survey that identified the above infection control issues and risks and that the revised Environmental Round sheets mainly addressed the infection control issues identified in the last survey. SF10IC indicated that she was not aware of the above infection control issues and had no further documented evidence to present to the surveyor.
In an interview on 02/15/16 at 12:45 p.m. with SF3DirPI (Performance Improvement) she indicated that the hospital mainly addressed the issues identified in the last survey and added those items (issues) to the Environmental Round sheets and developed monitoring tools to address those issues identified in the last survey. SF3DirPI indicated that she was not aware of the above issues and had no further documented evidence to present to the surveyor.
In an interview on 02/15/16 at 4:30 p.m. with SF1CEO she indicated that the hospital had future infrastructure plans that will address some of the issues identified by the surveyor. SF1CEO indicated that she did not know when the future infrastructure project would be started.