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Based on observation, interview, policy and procedure review and document review, lapses in generally acceptable infection control practices were identified in surgical attire, humidity and temperature in the operating room suite, endoscope reprocessing, and autoclave processing, which placed patients and staff at risk for infection.

See findings under Tag #A749.
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Based on observation, interview, policy and procedure review and document review, the facility did not develop an effective infection prevention and control system, which placed patients and staff at risk for infection; specifically:
1) Services were not provided in accordance with acceptable standards of practice regarding operating room attire.
2) The facility did not ensure that the humidity and temperature in 2 of 2 operating rooms (ORs), central sterile supply department, dirty utility room and post anesthesia care unit (PACU) were maintained within facility established parameters for 3 of 3 months reviewed.
3) Daily maintenance was not performed on the Scope Buddy at the beginning and end of the day.
4) Documentation was not maintained when the reagents and alcohol were changed on the Medivator - DSD EDGE.
5) Bowie-Dick tests were not performed each day the autoclave was utilized in the Central Sterile Supply department.
6) Biological indicators (BIs) were not tested weekly or when a sterilization load contained an implantable device.
7) BI information was not maintained as required when BI were tested during 2 of 2 months.


Findings pertinent to (1) above include:

Observation on 8/5/15 at 7:55 AM in OR #2 for Patient D revealed Staff #20 (General Surgeon) wearing a scrub skull cap with a "Michigan State" logo, and Staff #5 (Certified Registered Nurse Anesthetist - CRNA) wearing a disposable scrub skull cap with hair exposed on neckline and sideburns during abdominal surgery. Staff #20 wore regular glasses with no eye protection.

Observation on 8/6/15 at 8:30 AM in OR #2 for Patient M revealed Staff #21 (Orthopedic Surgeon) and Staff #5 both wearing a disposable scrub skull cap with hair exposed on neckline and/or sideburns during knee surgery. Staff #21 wore regular eyeglasses with no side eye protection.

These observations were confirmed during interviews on 8/6/15 with Staff #5 at 9:45 AM, Staff #7 (Registered Nurse (RN) OR Manager) at 9:55 AM, and Staff #21 at 10:30 AM. The staff indicated that wearing scrub skull caps by the CRNA and surgeons is the routine, and standard practice at the facility during surgery. Staff #21 also verified face shields/eye protection is needed when there is a potential for "blood spurt".

During interview on 8/6/15 at 3:45 PM with Staff #1, 2 and 24, the staff confirmed that Staff #20 wears surgical skull caps brought in from home, which are not laundered at the facility.

Review on 8/6/15 of policy #52.0008.3 "Attire, Surgical", last revised 8/2011, revealed the following:
- Scrub clothes are laundered between wearings by the facility.
- All possible head and facial hair, including sideburns and neckline should be covered when in the semi-restricted and restricted areas of the surgical suite. The surgical hat or hood should confine the hair.
- Protective eye wear or face shields are worn whenever activities place one at risk for a splash to the face or eye.

This policy does not support acceptable standards of practice governing surgical attire promoted by or established by nationally recognized professional organizations related to the confinement of head and facial hair.


Findings pertinent to (2) above include:

Review of facility policy #52.0029.2 "Maintenance and Documentation of Temperature and Humidity", revised 1/2015, indicated that temperature and humidity readings for the facility's two ORs, PACU, central sterile supply department and dirty utility room are to be obtained each day the ORs are open. The established parameters for the temperature are 68-73 degrees Fahrenheit (F), and the parameters for the humidity are 30-60%.

Review on 8/4/15 at 3:00 PM of the "Surgical Services Room Temperature/Humidity Log" revealed that the temperature and humidity in 2 of 2 ORs, PACU, central sterile supply department and dirty utility room were not within the facility established parameters, as follows:
- April 2015:
--- In OR #1, the temperature was not within the established parameters for 20 of 22 days (e.g., on 4/2/15 the temperature was 62 degrees F) and the humidity was not within the established parameters for 5 of 22 days (e.g., on 4/1/15 the humidity was 24%).
--- In OR #2, the temperature was not within the established parameters for 21 of 22 days (e.g., on 4/1/15 the temperature was 63 degrees F) and the humidity was not within the established parameters for 5 of 22 days (e.g., on 4/16/15 the humidity was 23%).
--- In the dirty utility room, the temperature was not within the established parameters for 21 of 22 days (e.g., on 4/22/15 the temperature was 63 degrees F) and the humidity was not within the established parameters for 7 of 22 days (e.g., on 4/16/15 the humidity was 17%).
--- In sterile supply, the temperature was not within the established parameters for 2 of 22 days (e.g., on 4/1/15 the temperature was 64 degrees F).
- May 2015:
--- In OR #1, the temperature was not within the established parameters for 18 of 20 days (e.g., on 5/13/15 the temperature was 64 degrees F) and the humidity was not within the established parameters for 1 of 20 days (on 5/5/15 the humidity was 64%).
--- In OR #2, the temperature was not within the established parameters for 18 of 19 days (e.g., on 5/22/15 the temperature was 63 degrees F).
--- In the dirty utility room, documentation was not provided.
--- In PACU, the temperature was not within the established parameters for 2 of 20 days (e.g., on 5/5/15 the temperature was 74 degrees F).
--- In sterile supply, the temperature was not within the established parameters for 2 of 20 days (e.g., on 5/1/15 the temperature was 66 degrees F).
- June 2015:
--- In OR #1, the temperature was not within the established parameters for 21 of 22 days (e.g., on 6/3/15 the temperature was 64 degrees F) and the humidity was not within the established parameters for 1 of 22 days (on 6/10/15 the humidity was 63%).
--- In OR #2, the temperature was not within the established parameters for 20 of 22 days (e.g., on 6/4/15 the temperature was 64 degrees F).
--- In the dirty utility room, the temperature was not within the established parameters for 18 of 22 days (e.g., on 6/1/15 the temperature was 66 degrees F).
--- In PACU, the temperature was not within the facility established parameters for 1 of 22 days (on 6/23/15 the temperature was 74 degrees F).

The policy also stated that if the temperature and humidity readings are not within the established parameters, maintenance staff is to be notified and documentation maintained for this activity. Review of the logs did not show evidence that maintenance had been notified or the corrective action that was performed.

These findings were verified with Staff #2 on 8/11/15 at 9:45 AM via telephone conference.


Findings pertinent to (3) above include:

Per interview on 8/5/15 at 7:30 AM with Staff #7 (RN OR Manager) and Staff #15 (OR Tech Aide), a Scope Buddy (endoscope flushing aid) is used as part of reprocessing activities for the facility's endoscopes. The staff stated that daily maintenance is not performed on the Scope Buddy at the beginning or end of the day.

Review on 8/5/15 of the manufacturer's recommendations for Scope Buddy revealed that Daily Quality Assurance Testing is to be performed at the start of each work day to ensure that the unit is operating properly and delivering a minimum of 100 cc of solution within the recommended 10 seconds. This validation process includes using the flow verification tube, fluid intake line, universal cleaning adapter extension line, the unit and a graduated cylinder of at least 200 cc.

The manufacturer also recommends that Scope Buddy and the associated tubing must be decontaminated at the end of each day when the unit is utilized. It is recommended that the fluid intake line be placed in a container of disinfecting solution and the solution drawn into the closed loop system for 2 minutes to ensure that adequate solution is present.

Observation on 8/5/15 at 9:40 AM of Staff #17 (Surgical Tech) while she was reprocessing the first endoscope utilized on 8/5/15 revealed that she did not perform the flow validation test for the Scope Buddy prior to using the device for endoscope reprocessing activities. Staff #17 utilized the Scope Buddy for flushing the channels of the endoscope prior to placing the scope in the automated reprocessing unit. When the surveyor inquired about validation testing, Staff #17 set the timer on the Scope Buddy for 60 seconds and proceeded to fill a 250 cc graduated cylinder via the operation of the Scope Buddy. Without the correct timer setting of 10 seconds for the Scope Buddy, it is not possible to determine if a minimum of 100 cc of solution is being delivered within the recommended timeframe. It was also noted that when the surveyor inquired about the end of the day activities for the Scope Buddy, Staff #17 indicated that she just pumps water into the Scope Buddy system so the tubing does not become dry.


Findings pertinent to (4) above include:

Review on 8/5/15 at 8:20 AM of the Filter Change Log - DSD Edge (the model of Medivator, used for automated reprocessing of endoscopes) revealed that the facility did not document when the disinfecting solutions and the alcohol were changed. The log indicated that the last documented solution change occurred on 12/18/11.

During interview on 8/5/15 at 8:35 AM, Staff #15 verified that the facility does not document when the solution is changed on the endoscope reprocessing unit. Staff #15 indicated that the solution has an expiration date of 21 days once it is placed on the unit.

During observation on 8/5/15 at 10:00 AM of Staff #17, it was noted that she was unsure of the expiration date once the solution had been placed on the unit. Interview with Staff #17 at this time showed that she thought the solution expired 25 or 28 days after being placed on the reprocessing unit.


Findings pertinent to (5) above include:

Review of policy #14.0002 "Sterilization Parameters", issued 10/2013, revealed that a Bowie-Dick test will be performed every morning before the load is started and that the results of the load will be documented upon completion of the load.

Review on 8/5/15 at 12:30 PM of the "Daily Sterilization Record Envelope" for May through July 2015 revealed that documentation was not provided to verify that a Bowie-Dick test (a test to monitor air removal efficiency of steam sterilizers, to ensure proper sterilization) is performed each morning before the autoclave in Central Sterile Supply was utilized. Comparison of the documentation with the surgical schedule for the same time frame showed that surgical procedures were performed on the following dates, but there was no record of performance of Bowie-Dick tests:
- May 2015:
--- Bowie-Dick test was not documented for 8 days: 5/1/15, 5/5/15, 5/7/15, 5/11/15, 5/12/15, 5/15/15, 5/19/15 and 5/22/15.
- June 2015:
--- Bowie-Dick test was not documented for 4 days: 6/4/15, 6/5/15, 6/15/15 and 6/30/15.
- July 2015:
--- Bowie- Dick test was not documented for 5 days: 7/14/15, 7/17/15, 7/24/15, 7/28/15 and 7/30/15.

These findings were verified with Staff #7 on 8/5/15 at 1:00 PM.


Findings pertinent to (6) above include:

Review of Policy #14.0002 "Sterilization Parameters", issued 10/2013, indicated that a BI (biological indicator) is to be tested weekly and with any load containing an implant.

Review on 8/5/15 at 1:00 PM of the "Daily Sterilization Record Envelope" and the operating room schedule did not provide evidence that a BI was processed weekly in the main autoclave located in the Central Sterile Supply room or when a load contained an implantable device. The following was noted:
- May 2015:
--- BI was not tested when implants were utilized 4 times: 5/11/15, 5/14/15, 5/18/15 and 5/19/15.
- June 2015:
--- BI was not tested the week of 6/29/15.
--- BI was not tested when two implants were utilized on 6/15/15.
- July 2015:
--- BI was not tested the weeks of 7/6/15, 7/13/15 and 7/27/15.
--- BI was not tested when an implant was utilized on 7/15/15.

These findings were verified with Staff #7 on 8/5/15 at 1:30 PM.


Findings pertinent to (7) above include:

Review on 8/5/15 of the manufacturer's recommendations revealed that the following information should be documented when a BI test is performed:
- The time the BI was put into the heating block and the time the BI was removed from the heating. The manufacturer recommends that the BI be incubated for 10 hours.
- The temperature of the heat block. The manufacturer recommends that the BI be incubated at 55-60 degrees Celsius.
- The lot number of the BI test and the BI control.
- The result of the BI test and control.

Review on 8/5/15 at 1:00 PM of the "Daily Sterilization Record Envelope" for May and June 2015 revealed that on the dates recorded that BI testing was performed (5/7/15, 5/13/15, 5/21/15, 5/26/15, 6/2/15, 6/9/15, 6/16/15, 6/22/15), BI information as recommended by the manufacturer was not documented, causing there to be no evidence that manufacturer's recommendations were followed.

These findings were verified with Staff #2 and 7 on 8/5/15 at 1:15 PM.
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Based on observation, interview, policy and procedure review and document review, the facility did not provide services in accordance with acceptable standards of practice regarding operating room attire, which placed patients and staff at risk for infection.

Refer to findings in Tag #A749.