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Tag No.: A0700
This condition level deficiency was cited during a Division of Life Safety survey completed on July 8, 2015. Further details are provided in the Division of Life Safety report.
Tag No.: A0749
Based on observations, review of facility documents, and interviews with staff (EMP), it was determined the facility failed to develop and implement an adequate infection control system to ensure the proper processing of surgical equipment and to maintain a sanitary hospital environment.
Findings include:
1) Review of the manufacturer instructions for the "Gyrus ACMI ... Self Autoclavable Semi-Rigid Ureteroscopes and Pediatric Cystoureteroscope," trademark date 2007, revealed " ... Section 5.0 Maintenance ... The following cleaning, disinfection, and sterilization procedures are recommended by Gyrus ACMI. Use of any procedure not expressly recommended by Gyrus ACMI may adversely affect or damage Gyrus ACMI devices ... 5.1 Cleaning ... 1. Clean the instrument by soaking in a warm solution (100-120 [degrees]F) of an enzymatic detergent for 5 minutes. ... "
Review of the manufacturer instructions for the "Storz Karl Storz - Endoskope ... Flexible Ureteroscope," no date, revealed " ... Warning: Karl Storz flexible ureteroscopes must be thoroughly cleaned and sterilized according to validated infection control procedures prior to use and subsequent reuse. ... Caution: Any deviations from the recommended parameters for cleaning and sterilization should be validated by the user. ... Cleaning Instructions for the Flexible Ureteroscope ... 4. Completely immerse the flexible ureteroscope in a neutral pH (pH 6.0 to 8.0) enzymatic cleaning solution (e.g Enzol, Metrizyme or equivalent diluted to proper concentration per manufacturer's instructions) and warm distilled/demineralized water. ... "
Observation on July 6, 2015, of the Torresdale campus decontamination room, revealed EMP35 did not immerse the flexible ureteroscope and the semi-rigid ureteroscope in an enzymatic cleaning solution prior to sterilization.
Interview on July 6, 2015, at 11:30 AM, with EMP18 confirmed the flexible ureteroscope and the semi-rigid ureteroscope were not immersed in an enzymatic cleaning solution prior to sterilization.
2) Review of facility policy "Cleaning/Processing of Instruments," dated December 31, 2014, revealed " ... B. Instruments, reusable supplies and equipment decontamination process ... 1. At the end of the surgical procedure, the scrubbed person separates the instruments in the OR room. 2. The instruments used during the procedure should be placed in a basin on the back table and sprayed with enzymatic cleaner. ... 8. The scrubbed person covers the back table with a waterproof drape for transportation to the decontamination room. ... "
Observation on July 8, 2015, of a surgical procedure at Frandford campus, revealed the instruments used during the procedure were not placed in a basin on the back table and sprayed with enzymatic cleaner.
Interview on July 8, 2015, at 11:15 AM, with EMP18 and EMP37 confirmed that the instruments used during the procedure were not placed in a basin on the back table and they were not sprayed with enzymatic cleaner.
3) Review of facility policy "Endoscopes/Equipment-Cleaning and Processing," dated March 26, 2015, revealed " ... VI. Procedure ... A. Steps in Procedure ... 15. Disconnect endoscopic flushing system from endoscope. Dry all removable parts and exterior of scope with 4x4 sponges before placing AER [Automated Endoscope Reprocessor]. .... "
Observation on July 8, 2015, of the Frankford campus decontamination room, revealed EMP34 did not dry any of the removable parts or the exterior of a scope with 4x4 sponges before placing the endoscope in the AER .
Interview on July 8, 2015, at 2:15 PM, with EMP18 confirmed that EMP34 did not dry any of the removable parts or the exterior of the scope with 4x4 sponges before placing the endoscope in the AER .
4) Review of facility policy "Processing Procedure for Instrumentation," no date revealed "I. Purpose: To prepare clean, properly functioning and correctly assembled procedure trays and instruments for terminal sterilization ... VI. Procedure: ... Essential Steps ... 8. ... Instruments with removable parts should be disassembled. ... "
Observation on July 9, 2015, of the Torresdale campus instrument processing area for sterilization, revealed EMP26 assembled a disassembled surgical instrument and prepared the assembled surgical instrument's to be sterilized in the assembled position.
A request was made to EMP18 on July 9, 2015, for a facility policy related to processing surgical instruments for sterilization that deviates from the facility's policy of disassembling surgical instruments prior to sterilization to ensure the deviated assembled surgical instruments surfaces were sterilized during the sterilization process.
Interview on July 10, 2015, at 1:15 PM, with EMP18 confirmed that EMP26 assembled a disassembled surgical instrument and prepared the assembled surgical instrument's to be sterilized in the assembled position. Further, EMP18 confirmed the facility did not have a policy related to processing surgical instruments for sterilization that deviates from the facility's policy of disassembling surgical instruments prior to sterilization to ensure the deviated assembled surgical instrument's surfaces were sterilized during the sterilization process.
5) Review of facility policy "Attire in the Operating Room," dated December 31, 2014, revealed " I. Purpose: An integral part of infection control in the Operating Room, OR staff, Physicians and visitors are required to be appropriately attired prior to entering the semi-restricted and restricted areas of the OR. ... II. Policy: A. Operating Room Attire within the Operating Room Suite ... b. Head Cover: 1) A clean, low-lint surgical head cover that confines all hair should be worn. 2) Disposable bouffant covers are preferred and provided by the hospital at OR entrances and in the locker rooms. 3) Skull caps that fail to cover the side hair above the ears and hair at the nap of the neck should not be worn in the surgical suite. ... d. Jewelry: 1) Jewelry including earrings, necklaces, watches, and bracelets that cannot be contained or confined within the surgical attire will not be worn, all jewelry should be confined or removed before entry into the semi restricted or restricted areas. ... "
Review of facility policy "Dress Code," dated March 1, 2014, revealed " ... II. Policy: A. Processing personnel are required to wear ... caps, which entirely cover the hair including sideburns and beards. ... "
Observation on July 6, 2015, of the Torresdale campus surgical suite's "Restricted and Semi Restricted" areas, revealed the following: EMP28, EMP29, EMP30 and EMP32's head and / or facial hair were observed not completely confined.
Interview on July 6, 2015, at 12:15 PM, with EMP18 confirmed the above findings.
Observation on July 7, 2015, of a surgical procedure at the Torresdale campus, revealed the following: EMP21's head hair was observed not completely confined; EMP22 was observed wearing a necklace which was observed not confined within EMP22's surgical attire; and EMP23's earrings were observed not confined within EMP23's surgical attire.
Interview on July 7, 2015, at 1:00 PM, with EMP24 confirmed the above findings.
Observation on July 8, 2015, of a surgical procedure at the Frankford campus, revealed the following: EMP19's facial hair was observed not to be confined; EMP20 was observed wearing a necklace which was observed not confined within EMP20's surgical attire.
Interview on July 8, 2015, at 9:45 AM, with EMP18 confirmed the above findings.
6) A request was made to EMP16 on July 10, 2015, for a facility policy related to the maintenance and repair of the facility's building infrastructure. EMP16 stated that the facility is currently working on a policy, which is currently being finalized.
Observation of the facility's alcohol-based hand rub dispensers revealed the following:
The sensor automated alcohol-based hand rub dispenser located outside of the Torresdale campus Endoscopic Procedure room was observed not working on July 6, 2015.
Interview on July 6, 2015, at 10:00 AM, with EMP18 confirmed the above finding.
The sensor automated alcohol-based hand rub dispenser located outside of the Torresdale Campus Emergency Department "Treatment Room Three" was observed not working on July 7, 2015.
Interview on July 7, 2015, at 10:35 AM, with EMP14 confirmed the above finding.
Observation on July 7, 2015, of the Torresdale Campus Short Procedure Unit's Pre-operative and Post-operative Care unit, revealed two alcohol-based hand rub dispenser marked expired May 2015, and one alcohol-based hand rub dispenser marked expired June 2015.
Interview on July 7, 2015, at 12:00 PM, with EMP18 confirmed the above finding.
The sensor automated alcohol-based hand rub dispenser located outside of the Frankford Campus Emergency Department "Treatment Rooms 25 and 29" were observed not working on July 8, 2015.
Interview on July 8, 2015, at 12:00 PM, with EMP37 confirmed the above findings.
Observation on July 6, 2015, of the Torresdale campus sterile storage room, revealed various amounts of debris located underneath and between the storage racks.
Interview on July 6, 2015, at 11:15 AM, with EMP18 confirmed the above findings.
Observation on July 7, 2015, of the Torresdale campus Short Procedure Unit's procedure room, revealed a hole in the wall, which was observed in the area where the procedure room's door would open.
Interview on July 7, 2015, at 9:40 AM, with EMP14 confirmed there was a hole in the procedure room's wall, where the door would open.
Observation on July 8, 2015, of Frankford campus "Operating Room Two," revealed that there were two ceiling screws observed to be loose located above the surgical field.
Interview on July 8, 2015, at 11:30 AM, with EMP18 confirmed that there were two ceiling screws observed to be loose located above the surgical field.
7) Review of facility policy "Labeling Standards," dated October 20, 2014, revealed " ... II. Policy: All medication containers shall be labeled and medication labels must be clear, consistent, legible and in compliance with state and federal requirements. There shall be a standard method for appropriately and safely labeling medications dispensed to both inpatients and outpatients.
Observation on July 8, 2015, of a surgical procedure at the Frankford campus, revealed there was a syringe which contained an unknown white liquid substance located on the anesthesia cart which had no label to identify what the medication was or what time and date the medication was prepared/drawn.
Interview on July 8, 2015, at 10:15 AM, with EMP33 confirmed there was a syringe which contained an unknown white liquid substance located on the anesthesia cart which had no label to identify what the medication was or what time and date the medication was prepared/drawn.