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Tag No.: A0749
Based on observation and staff interviews, the facility failed to develop and implement measures governing the prevention and control of cross contamination in the operating rooms and endoscopy procedure room when:
1) An endoscopy technician washed used scopes in the decontamination area without wearing any personal protective equipment (PPE) and dirty endoscopes were decontaminated in the same room as clean endoscopes are handled as well.
2) Operating Rooms 3 & 4 (OR 3,4) had cracks in the seams of the linoleum restricting the ability to clean the flooring adequately.
These practices and incident increased patients' risk of developing surgical site infections and cross contamination between patients.
Findings:
1) The endoscope procedure room consisted of a storage area with bathroom, and a decontamination room. The decontamination room had a basin for soaking dirty scopes, lavatory for gastric wastes disposal, piped in pressurized air, sink, supply cart and the automatic ultrasonic custom washer for scopes.
An endoscopy procedure done for Patient 3 was observed on 4/17/13 at 9:15 a.m. in the endoscopy procedure room. After the procedure, it was observed that Endoscope Scrub Tech 1 brushed and sponged the dirty scope in the decontamination room without wearing any gown, mask or face protection. He wore only a pair of gloves.
It was also observed that the Endoscope Scrub Tech 1 placed the washed scope in the automatic ultrasonic custom washer for scopes, then, dried it using compressed air and kept it on top of a table surface nearby.
The Chief Nursing Executive was interviewed on 4/19/13 at 6:30 a.m. She confirmed that the decontamination area in the endoscopy room is not physically separated from clean items.
Perioperative Standards and Recommended Practices, 2013 Edition on Cleaning and Processing Flexible Endoscopes and Endoscope Accessories was reviewed and the following recommendations were noted:
Recommendation XI reads, "flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed. This minimizes the risk of cross-contamination resulting when soiled items are placed in close proximity to clean items. Aerosols created during cleaning can also cause cross-contamination".
Recommendation XII reads, "Personnel handling contaminated endoscopic equipment must wear appropriate PPE. PPE helps to protect staff from exposure to bloodborne pathogens and other potentially infectious materials. Splashes, splatters, and skin contact can be reasonably anticipated when handling contaminated flexible endoscopes".
2. On 4/17/13 at approximately 8 a.m., a tour was conducted of the perio-operative (pre and post operative) and surgical area with the Assistant Operating Room Manager (AORM) and the Chief Nurse Executive (CNE). In the pre-operative area, the flooring was noted to be linoleum square tiles. There were several tiles that had cracks and chips along the seams. The tour continued to the surgical suites. The flooring in Operating Rooms 3 & 4 showed cracks and fissures along the joint seams with the more significant damage in OR 4. The CNE and the AORM both acknowledged that the flooring was in need of repair.
Tag No.: A0951
Based on observation, interview, and Surgical Policy & Procedure review, the facility failed to operationalize policies that were designed to meet standards of medical practice and patient care when:
1. A surgeon (S1) was observed wearing a cap in surgery that did not cover the back of his hair. The failure could have the potential to contaminate the sterile surgical field.
2. Open wire carts were observed to transport soiled reusable instruments from the operating rooms, through a semi-restricted area, to a decontamination area without the instruments being covered.
3. The hospital failed to maintain appropriate temperature and humidity (T&H) controls in 4 of 4 Operating Rooms (OR) when the temperature in OR 3 was observed to be 65.5 degrees and the humidity was 29%. A review of the T&H logs for all OR's, from October 2012 to March 2013, indicated multiple dates of inadequate temperature/humidity controls.
This failures may result in exposure of patients, personnel or equipment to contaminants.
Findings:
1. At approximately 9:05 a.m. on 4/18/13, the end of a surgery was observed. The surgeon (S1) was in full sterile surgical attire at table side, which included a mask, cover gown, gloves, booties and cap. The surgical cap was the type that covers the top of the head and ties at the back of the head. It was noted that S1 had curly hair that was exposed to the environment.
At 2:10 p.m., on this same date, an interview was conducted with the Operating Room Manager (ORM). The ORM acknowledged that some of the surgeons do continue to wear the surgical caps referred to as "skull caps" that cover mostly the top of the head to about the ears but allows hair in the lower back of the cap to be exposed. She also stated that some of the surgeons wear the "bonnet" type that encompasses the whole head and covers all hair.
A policy from the Operating Room Policy and Procedure Manual titled Dress Code/Attire, dated 9/10 was reviewed and under section C. Surgical Head Covers staff were instructed that (1) Disposable surgical head covers must be worn in the semi-restricted and restricted areas of the surgical suite and (2) all hair (including facial) must be completely confined by the surgical head covers...
2. On 4/17/13, the end of a morning surgical procedure was observed in Operating Room 4 (OR 4). The scrub technician was observed to collect soiled used instruments and put some of them into bins and some into open metal bowls, then the instruments were sprayed with an enzymatic cleaner. These containers were place on an open wire cart. The disposable trash from the procedure was bagged up and placed on the cart and moved out of OR 1 through the semi-restricted hallway and into the decontamination room. An interview was immediately conducted with the scrub technician about this procedure. He said that he collects all instruments into a bin and sprays them with the enzymatic cleaner sprayer, puts the trash on top of the cart and takes it to decontamination.
On 4/18/13 at approximately 9:20 a.m. the end of another surgery was observed. This procedure was also done in OR 4. The same scrub technician was observed to collect the instruments and place them in containers, again some where placed in a metal bowl and some into a bin. All instruments were sprayed with the enzymatic cleaner. The bin was covered and the bowl remained open. The trash was placed on the cart and the cart was wheeled through the semi-restricted hallway and to the decontamination room.
The carts were transported through a semi-restricted area that was behind double doors with signage that said "Authorized Personnel Only". The Assistant OR Manager (AORM) confirmed that unauthorized personnel or others in street clothes were not allowed beyond the double doors. Observed in this hallway were emergency rescue carts, and various large pieces of equipment.
An undated document with no review dates, titled "Transportation of Contaminated Instruments was provided to the Department. This policy contained instructions that, "Contaminated instruments must be contained during transport... . Soiled reusable instruments shall be transported to Central Sterile Processing Department in a leak proof closed container.... The 2012 AORN Perioperative Standards and Recommended Practices, under high level disinfection notes the following recommendation of "Soiled instruments and devices should be ... transported in a contained, covered and secure manner to the point of decontamination and processing.
3. On 4/17/13 at approximately 9:30 a.m., a tour of OR 3 was conducted with the Assistant Operating Room Manager (AORM) to enter and observe the T&H gauges/control. The temperature gauge appeared to be a standard wall mount digital thermostat and indicated the temperature was 65.5 degrees. The humidity gauge was mounted next to the thermostat and read 29%. The AORM acknowledged these readings and said that the circulating nurse is the one responsible to check these daily. At this time, the T&H logs from October 2012 to the present were requested.
T&H Logs from October 2012 to March 2013 were received and reviewed. The logs consisted of pages where there was an area to write in the month and year. Above the year/date area was the instruction that "Room temperature shall remain between 68 degrees F and 73 degrees F" and "Humidity of the room shall remain between 35% and 60%". Below these were dates and areas to write in the temperature and humidity. Next to these were blocks with the notation at the top "If out of range, staff notified and action taken.
Review of the logs showed many dates in all months reviewed in which either the temperature and/or humidity was out of the ranges indicated. The lowest noted temperature was 59.5 degrees in OR 2 on 3/25/13 and the lowest humidity was 18% in OR 4 on 1/10/13. There were many temperatures recorded in the low 60's and humidity level was in the 20's. There were many days where temperatures and humidity levels were not documented on the logs. There where many instances where the temperatures or humidity levels was documented as out of range but there was no documentation of what actions were taken or if anyone was notified.
The logs were reviewed with the OR Manager (ORM) the Facilities Manager (FM) and the Chief Nurse Executive (CNE).
During an interview on 4/17/13 at 3 p.m., with the FM, he acknowledged the temperature and humidity was not within prescribed limits. The FM said that the thermostats controlled the temperature and that there were no humidity controls. The FM said that the OR staff had to try to manipulate the humidity by the temperature settings and that the humidifiers were shut down about 15 years ago.