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Tag No.: A0726
Based on review of humidity logs, staff interview, and review of facility policies, the facility failed to ensure equipment and supplies were stored in areas with adequate humidity in accordance with manufacturer's instructions in 2 of 2 surgical areas (main hospital and outpatient surgery clinic). The findings were:
1. Review of humidity logs provided by the facility for the main hospital's surgical area showed humidity was monitored in the operating room (OR) suites, but not in the procedure rooms or the sterile storage room. During an interview on 3/28/18 at 2 PM the OR manager stated humidity was not monitored by staff in the procedure rooms or the sterile storage area. She also stated they had not reviewed the manufacturer's instructions for use for all of the medical equipment and supplies stored in those areas to determine what the humidity requirements were.
2. Review of humidity logs provided by the facility for the outpatient surgical center showed humidity was monitored in the OR suites, but not in the procedure room or the sterile storage area. During an interview on 3/28/18 at 10:52 AM the clinical manager stated they did not monitor humidity in the procedure room or sterile storage area. She also stated she not have any evidence to show the manufacturer's instructions for use were followed regarding humidity requirements for the equipment and supplies stored in those areas.
3. Review of the facility's policy "HVAC" (dated 1/8/18) showed "Relative humidity should be maintained within the HVAC design parameters. a. In a restricted area, the relative humidity should be maintained within a range of 30%-60%. b. In a semi-restricted area, the relative humidity is related to the function performed in that area: i. Clean/sterile storage: 30%-60%....Restricted Area: Includes OR and procedure room, clean core and scrub areas..."
4. Review of "Guidelines for Perioperative Practice", by the Association of periOperative Registered Nurses (AORN), 2015, revealed in the "HVAC Design Parameters" that the clean/sterile storage should have humidity of "Maximum 60%." The procedure room should have a humidity level of "20% to 60%."
5. Review of "Humidity Levels in Surgical Settings: Understanding the Standards and Managing the Risk," Gallagher Healthcare Practice, April 2015, showed "...low humidity level can adversely impact equipment, supplies and shelf life. As a starting point, it is essential that the OR staff and suppliers are familiar with the manufacturer's Instructions for Use (IFU)...As assessment of the IFU's for equipment and supplies used in the OR (electrodes, shelf life, etc) will determine the required humidity requirements for using or storing the equipment..."
6. Review of "Relative Humidity Levels in the Operating Room Joint Communication to Healthcare Delivery Organizations," January 2015, (http://s3.amazonaws.com/rdcms-aami/files/production/public/FileDownloads/News/Humidity_in_OR_Joint_Communication_to_HDOs_January_2015.pdf ) showed "...relative humidity can impact the shelf life and product integrity of sterile supplies. Some products, such as biological indicators and chemical indicators used for sterilization monitoring and EKG electrodes used for patient monitoring are very sensitive to humidity...It is important for personnel to know and understand the IFUs specific to all supplies and equipment, and in particular know what environmental humidity requirements are specified in the IFU...Relative humidity [relative humidity] may affect the operation of some electro-medical equipment used in the OR...too low humidity may also impact calibration...Note: Supplies that currently require minimum RH levels of 30% or higher are used throughout a healthcare facility (e.g., EKG electrodes). While this risk assessment is specific to the OR, the same process should be considered for other areas where RH levels are going below 30% by design or effect."
Tag No.: A0749
Based on observation, staff interview, and review of manufacturer's instructions and facility policies, the facility failed to ensure staff adequately disinfected surfaces in the operating room (OR) during 3 of 3 observations, and failed to ensure 2 of 4 certified registered nurse anesthetist (CRNAs) utilized safe injection practices during the provision of care for 2 of 3 patients (#11, #43). The findings were:
With regard to disinfecting surfaces in the OR:
1. Observation on 3/28/18 at 10:48 AM at the outpatient surgery center revealed scrub tech #1 was cleaning the procedure room following a case. The scrub tech was using "Cavi Wipes XL" to wipe the surfaces with. At 10:49 AM the scrub tech wiped the OR bed/table. At 10:50 AM (1 minute later) the bed/table was not visibly wet; it appeared to be drying. When asked what the contact time was for the Cavi Wipes, the scrub tech replied "I think it's 15 seconds." Observation of the product label for the Cavi Wipes showed "For use as disinfectant: Repeated use of product may be required to ensure surface remains wet for 3 minutes." During an interview on 3/28/18 at 10:52 AM the clinical manager confirmed the Cavi Wipes had a three minute wet contact time.
2. Observation on 3/27/18 at 10:06 AM revealed registered nurse (RN) #1 and certified nurse aide (CNA) #1 were cleaning OR #1 following a case. The CNA stated the product they were using to wipe the surfaces was "Virex II" and it had a 10 minute contact time. Observation showed the surfaces did not remain wet for 10 minutes. For instance, at 10:14 AM a table was wiped; at 10:17 AM (3 minutes) there were drying streaks, and by 10:20 AM (6 minutes) it no longer looked wet. Review of the instructions of the bottle of "Virex II" showed "Allow to remain wet for 10 minutes."
3. Observation on 3/28/18 at 5:06 PM revealed environmental services staff # 1 terminally cleaned OR #4. The staff person stated she was using "Virex II" to disinfect the surfaces. During the observations, the surfaces did not remain wet for 10 minutes. At 5:09 PM the monitor was wiped; at 5:12 PM (3 minutes later) there were drying streaks visible. At 5:44 PM the OR bed/table was wiped; by 5:52 PM (8 minutes later) it appeared to be 50% dry.
4. Review of the facility's policy "Decontamination of Operating Room Suite" (dated 2/20/18) showed "Disinfectants should be applied and reapplied as needed per manufacturer's instructions for the dwell time (wet time) required to kill the targeted micro-organism."
5. During an interview on 3/28/18 at 4:12 PM the infection control preventionist stated she believed environmental services did some audits, but stated she had not been doing any audits to ensure adequate disinfection in the ORs.
With regard to safe injection practices:
1. Observation on 3/27/18 at 8:30 AM revealed CRNA #1 withdrew propofal into a syringe, then withdrew lidocaine into the same syringe, and injected the mixed solution into patient #43's intravenous port. During the observation the CRNA did not disinfect the medication vials prior to piercing; nor did she disinfect the intravenous tubing entry port prior to the injection.
2. Patient #11 was observed during pre-operative care on 3/27/18. Observation between 9:37 AM and 9:44 AM revealed CRNA #2 administered anesthesia to the patient and injected 4 different intravenous medications into the same intravenous tubing entry port without disinfecting the port prior to entry.
3. Review of the Infection Prevention Policy and Procedure, titled, "Guidelines for Prevention of Intravenous-Related Infections, authorized by the infection control committee on 2/20/18, showed "All entries into the tubing, as for administration of medication, should be made through ports that are disinfected just before entry". Further review showed the facility had not developed an infection prevention policy and procedure regarding disinfecting the septum on medication vials prior to piercing.
Interview on 3/29/18 at 4 PM with the quality risk and care manager verified the staff did not follow the policy and procedure.
Tag No.: A1005
Based on medical record review and staff interview, the facility failed to ensure a post-anesthesia evaluation was completed and documented for 4 of 9 sample patients (#6, #10, #27, #32) who received anesthesia. The findings were:
Medical record review on 3/28/18 for patients #6, #10, #27, and #32 showed each had received anesthesia. Further review revealed the following concerns:
a. Medical record review for patient #6 showed she received an epidural on 3/25/18 at 7:45 PM for active labor. Review of the Pre-Anesthesia Evaluation form showed an area titled, "POST OP ANESTHESIA EVALUATION" that was signed. However, the actual evaluation was left blank. Review of the entire medical record showed the facility failed to ensure a post-anesthesia evaluation was completed.
b. Medical record review for patient #10 showed she received an epidural on 2/7/18 at 3 PM for active labor. Review of the Pre-Anesthesia Evaluation form showed an area titled, "POST OP ANESTHESIA EVALUATION" that was signed. However, the actual evaluation was left blank. Review of the entire medical record showed the facility failed to ensure a post-anesthesia evaluation was completed.
c. Medical record review for patient #27 showed s/he received general anesthesia on 3/12/18 at 10:01 AM. Review of the Pre-Anesthesia Evaluation form showed an area titled, "POST OP ANESTHESIA EVALUATION" that was signed. However, the actual evaluation was left blank. Review of the entire medical record showed the facility failed to ensure a post-anesthesia evaluation was completed.
d. Medical record review for patient #32 showed s/he received general anesthesia on 12/19/17 at 9:19 PM. Review of the Pre-Anesthesia Evaluation form showed an area titled, "POST OP ANESTHESIA EVALUATION." However, the actual evaluation was left blank and unsigned. Review of the entire medical record showed the facility failed to ensure a post-anesthesia evaluation was completed.
e. Interview with registered nurse #1 on 3/28/18 at 6 PM confirmed the post-anesthesia evaluations were not completed for patients #6, #10, #27, and #32.