HospitalInspections.org

Based on observation, it was determined that the facility failed to implement its contact isolation procedures.

Findings include:

Reference: Facility Policy and Procedure titled 'CONTACT PRECAUTIONS (ISOLATION)' states "Policy Statement: Contact precautions will be used to prevent the transmission of epidemiologically important microorganisms by direct or indirect contact. Policy: Contact Precautions will apply to specified patients known, or suspected to be infected or colonized with epidemiologically important microorganisms. ... Procedure: Contact Precautions Wash or decontaminate hands upon entering & leaving room. ..."

1. On 5/26/11 at 12:40 PM, in the presence of Staff #1, an employee was observed exiting Room #3211. This room had a Contact Isolation sign posted outside, indicating that the patient in the room was on contact isolation. The employee had a protective gown and gloves on. The employee did not remove the gown and gloves after exiting the patient room or wash his/her hands per facility policy. After exiting Room #3211, the employee proceeded to the linen cart, lifted its cover, and removed two towels. He/she then re-entered Room #3211.

Based on observation, staff interview and review of facility documents, it was determined that the hospital failed to provide surgical services that are well organized and in accordance with accepted standards of practice.

The facility failed to ensure that all equipment is maintained at an acceptable level of safety and quality. Consequently the Condition for Coverage of Surgical Services was not met.

Specifically, the hospital was performing a substantial number of traditional flash sterilization procedures and documentation was not readily provided to confirm that biological indicators consistently accompanied flash-sterilized implantable devices.

It was further determined, based on the findings, that a situation in which the potential for patient harm existed, therefore, an immediate jeopardy was instituted.

Subsequently the hospital provided an acceptable plan of correction and the Immediate Jeopardy was abated.

Findings include:

1. The facility failed to ensure that surgical services were provided in a clean environment. (Cross refer Tag 0951).

2. The facility failed to ensure that surgical services were provided with supplies that were maintained within acceptable guidelines per facility policy, manufacturer's guidelines, and standards set by the Association for the Advancement of Medical Instrumentation (AAMI) . (Cross refer Tag 0951).

3. The facility failed to develop policies and procedures for the proper handling and transport of flash sterilized items for immediate use, and for staff attire when they are handling sterile supplies or performing flash sterilization, as per the standards set by the Association for the Advancement of Medical Instrumentation (AAMI) . (Cross refer Tag 0951).

A. Based on a tour of the Operating Room suites and staff interview, it was determined that the facility failed to ensure that all areas, including areas with limited access such as cabinets, drawers, locked medication rooms, and storage areas, were kept clean to sight and touch.

Findings include:

A tour of eight (8) "Sub -Sterile" rooms located within the Operative suites, was conducted on 5/26/11 at approximately 11:30 AM, in the presence of Staff
#4 and #6.

1. In the "Sub-Sterile" room located between Operating Room #1 and Operating Room #2, the following was observed:

a. A thick layer of dust on top of the autoclave sterilization equipment.

b. A liner pad soaked with a clear liquid was under a supply container on top of the handwashing sink.

c. Green surgical clothing was stored on top of an uncovered portable bin.

d. A ceiling tile had visible water stains.

e. A blue and a red plastic storage container located on the counter next to the handwashing sink were coated with dust on their interior and exterior surfaces.

2. In the "Sub-Sterile" room located between Operating Room #3 and Operating Room #4, the following was observed:

a. Two blue storage containers were stored on the floor under the handwashing sink.

b. A blue and a red plastic storage container located on the counter next to the handwashing sink were coated with dust on their interior and exterior surfaces.

c. Green surgical clothing was stored on top of an uncovered portable bin.

d. A dust covered glass jar located on the counter top of the handwashing sink contained unidentifiable debris.

e. Paper trash was located behind a storage container stored on top of the hand washing sink.

3. Staff #8 stated during interview on 5/26/11 at approximately 12:30 PM, that the environmental staff had not included the "Sub-Sterile" rooms as part of the daily cleaning schedule of the operating rooms.

4. The above observations were confirmed by Staff #4 and Staff #5 on 5/26/11.


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B. Based on review of facility policies and procedures, it was determined that the facility failed to develop policies and procedures for the proper handling and transport of flash sterilized items for immediate use, and for staff attire when they are handling sterile supplies or performing flash sterilization, as per the Association for the Advancement of Medical Instrumentation(AAMI) guidelines.

Findings include:

Reference #1: AAMI ST 79 section 3.3.7.3 on 'Sterilization area' states: "Sterilizers to be used for flash sterilization of unwrapped items for immediate use should be located in the restricted area of the surgical suite or treatment site, where personnel are required to wear full surgical attire, to cover all head and facial hair, including sideburns and necklines, and to wear masks in the vicinity of open sterile supplies."

Reference #2: AAMI ST 79 section 4.5.3 on 'Sterilization area (flash sterilization)' states: "...personnel working in areas where items are flash-sterilized should wear a liquid resistant face mask. Other protective and/or sterile attire might also be necessary depending on the method by which items are transferred from the sterilizer to the point of use."

(Note: ST 79 replaces and supercedes ST46 by consolidating ST 46 with 4 other AAMI standards [ST33, ST37, ST42, and ST35] approved 7/10/2009).

1. Operating room policies and procedures have not been developed on proper handling and transport of flash sterilized items, items for immediate use, and staff attire, as per AAMI guidelines in References #1 and #2 above.


C. Based on observation, review of Operating Room flash sterilization logs, sterilizer records, and staff interview, it was determined that the facility failed to sterilize all equipment in accordance with manufacturer's guidelines.

Findings include:

Reference: AAMI ST 79 section 7.2.2 on 'Manufacturer's instructions 'state: "The written recommendations of the device manufacturer should always be followed."

1. On 5/23/11, a double squeeze bulb was observed inside the 'Medical Thoracoscopy' tray. The manufacturer of the double squeeze bulb's sterilization perimeters states: "The double blower should be cleaned with a moist cloth and if necessary sprayed off using a disinfection solution." Staff #15 stated that this double squeeze bulb gets routinely sterilized as part of the Medical Thoracoscopy tray and was not aware of its specific sterilization requirements.

D. Based on observation, review of Operating Room flash sterilization logs, sterilizer records, and staff interview, it was determined that the facility failed to ensure that methods for processing reusable medical devices conform with the Association for the Advancement of Medical Instrumentation(AAMI) ST79:2006 Comprehensive guide to Steam Sterilization and sterility assurance in health care facilities.

Reference: #1 AAMI ST 79 section 8.6.2 titled 'Flash Sterilization parameters' states: "Flash sterilization of implantables is not recommended."

Reference #2: AAMI ST 79 section 11.2.4 states: "Procedures for flash sterilization should be based on a documented quality process that measures objective performance data."

Reference #3: CDC's Guideline for 'Prevention of Surgical site Infection, 1999, section C. Recommendations, Intraoperative d.2' states, "Do not flash sterilize for reasons of convenience, as an alternative to purchasing additional sets, or to save time."

1. On 5/23/11, based on review of flash sterilization records, Staff #17 identified a total of 4 implantable devices as items that were flash sterilized during the month of May 2011. These items were identified as a 'Synthes crani set', 'plates', 'knee metal' and 'shoulder screws'.

a. Based on the facility's flash sterilization key, the reason cited for flash sterilization of these implantable devices were as follows: 'turned over item,' 'unsterile from SPD,' 'holes in wrapper.'

b. The Synthes crani set is an implantable device.

c. The Synthes crani set did not have the reason for flashing.

d. It is not recommended by AAMI guidelines in Reference #1 to flash the Synthes crani set.

2. Review of sterilizer #11's flash sterilization records from 5/5/11 to 5/20/11, and interview with Staff #17, revealed that a total of 24 loads of instruments were flash sterilized with 12 of 24 loads reasons for flashing as 'turned over item,' 'unsterile from SPD,' 'and unsterile from rep'.

As per Reference #3, items should not be flash sterilized for reasons of convenience, as an alternative to purchasing additional sets, or to save time.

3. A total of 3 of 4 loads that were flash sterilized on 5/13/11 in sterilizer #10, did not have documented, the reason why the instruments were flash sterilized.

4. The May 2011 sterilization records for sterilizers #10, #11, #13 and #14, provided by the hospital on May 26, 2011, had a total of 37 traditional (unwrapped, uncontained) flash sterilization loads documented.

E. Based on observation, review of Operating Room flash logs, sterilizer records, and staff interview, it was determined that the facility failed to ensure that a biological monitoring test with each load containing implantables, was performed.

Findings include:

Reference #1: Facility policy and procedure on "AUTOCLAVES" states: "Biological monitoring of Implantables: 1) Whenever possible, all implantables will be processed through Supply Processing and Distribution (SPD) with a biological indicator. Items will be quarantined until the biological has been processed and negative reading takes place. Implantable items will have a label indicating sterilization date and time and when the item is released from hold (quarantine). Verification of release is coordinated through a supervisor in SPD. 2) In an emergency, a held item may be unwrapped and processed with a one hour Attest biological indicator. 3) If it is necessary to flash an implantable, a one hour biological indicator and a Steam Chemical Integrator will be used. The item will be quarantined until after the one hour indicator is read as negative on a separate table."

Reference #2: Facility policy and procedure on "Steam Biological and Chemical Monitoring" states: "For quality assurance, a test packs present a challenge to the sterilization process and are to be used to monitor each autoclave daily and with every implantable device ....Whenever possible, all implantables will be processed through Central Supply with a biological indicator. Steam sterilized implantables: In an emergency, a held item may be unwrapped and reprocessed with a 1 hour Attest biological indicator (used in OR flash sterilizers only)."

1. On 5/23/11, based on review of flash sterilization records with Staff #17, Staff #17 identified a total of 4 implantable devices as items that were flash sterilized during the month of May 2011. These items were identified as a 'Synthes crani set', 'plates', 'knee metal' and 'shoulder screws'. Biological monitoring tests were not performed on 3 of the 4 implantable device loads. The 'Synthes Crani set' was the only set that had a biological monitoring test performed.

2. On May 26, 2011, a sterilization record dated March 15, 2011 for sterilizer
#11 was provided to the surveyor. The record indicated that one flash sterilization load (load #4) that contained an implantable device. The biological indicator for this load was not documented.

F. Based on observation, it was determined that the facility failed to ensure that all cabinets and areas with limited access were kept clean to sight and touch.

Findings include:

Reference: Facility policy and procedure #9.01 titled 'Crothall Services Group: Surgery Cleaning' states: "The Operating Room is one of the most critical areas of the hospital. Extreme care must be taken to ensure the following schedule is carried out rigorously and in accordance with departmental procedure."

1. On 5/23/11 at 12:15 AM, the two sub-sterile rooms located in 'Cluster 2 and Cluster 3' of the Operating Room suites were observed with a heavy accumulation of dust. The dust accumulation was observed on and behind the sterilizers, inside the clean storage cabinet, inside the towel warming cabinet and near the handwashing sinks.

2. On 5/23/11 at 11:45 AM, a cabinet in Cluster 2 located under the handwashing sink, contained used rags.

a. An unclean and dusty 'Flash Guard' container was stored next to the handwashing sink. Staff #15 stated that he/she had purchased this 'Flash Guard' container, intended for flashing. However, it was not currently being utilized by all operating room staff due to its complex usage guidelines. The container was immediately removed by Staff #15.

3. The facility's 'Surgery Cleaning' policy and procedure did not address routine cleaning of the sub-sterile rooms in the 'daily routine cleaning' section.

G. Based on observation in the sub sterile rooms located in the Operating Room suites, it was determined that the facility failed to ensure that floors are kept clean.

Findings include:

Reference: Facility policy and procedure #9.01 titled 'Crothall Services Group: Surgery Cleaning' states: "The Operating Room is one of the most critical areas of the hospital. Extreme care must be taken to ensure the following schedule is carried out rigorously and in accordance with departmental procedure."

1. On 5/23/11 at 12:15 AM, the floors of the two sub-sterile rooms located in 'Cluster 2 and Cluster 3' of the Operating Room suites were observed to have discolored, stained, and encrusted deposits at the floor wall perimeter.

2. The facility's 'Surgery Cleaning' policy and procedure did not address routine cleaning of the sub-sterile rooms in the Operating Room suites, in the 'daily routine cleaning' section.