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Based on observation, interview, and record review the facility failed to ensure: 1.) the Documentation of a system for identifying and preventing infections and communicable diseases in 2 (Central Sterilization Department and Sterilization Services Department) out of 2 departments that use sterilizing machines. These departments perform sterilization of critical and semi-critical equipment for invasive and surgical procedures for patients throughout the entire hospital; 2.) The nursing staff administers injectable medication in accordance with the accepted infection control standards of practice in 1 (SP#43) of 61 Sampled Patients (SP).


Findings include:

1) (a) Observation on 2/25/2014 at 10:21am of the Central Sterilization Service Department revealed the department is within the surgical services department and connected to the main hallways off of the facility ' s operating rooms. There were 2 fairly large rooms that make up this department.

Observation on 2/25/2014 at 11:35am of the (large) Sterrad machine revealed that the Preventative Maintenance (PM) sticker listed on the machine for the facility ' s biomedical department read 1/31/2014; which reflects this check was overdue by almost 1 month. Additionally the PM for the manufacturer read 4/2014; however further review of the actual printout(s) from the machine revealed the PM was overdue by over 167 cycles. The department Supervisor was present for this observation and confirmed these findings.

Interview on 2/25/2014 at 11:35am with the department ' s biomedical engineer revealed that the Sterrad machine has 2 scheduled PM ' s; one was for his checks and the other was for the manufacturer. He reports that he had completed his check and will update the sticker. He reports he will contact the manufacturer to facilitate a PM for this unit.

(b )Observation on 2/28/2014 at 10:04am of the Sterilization Services and Linen Services Department revealed the department is on the bottom floor of the facility. There were 2 fairly large rooms that make up this department.

Review of the items in a book titled, " Materials Management Steam Sterilization Recording Log Book, " reflects that the department processes a Biological Indicator (BI) test daily as per the manufacturer guidelines for the Autoclaves. The facility demonstrates an example of the BI which reflects they are using the 1292 Attest rapid readout BI (with the brown top).

Review of the staff documentation reflects that the staff places the 1292 BI in the incubator and " read " the results in 2 hours as opposed to the 3 hours recommended by the manufacturer. This was evident for all of the daily testing in the month of January 2014 and February 2014. The department Manager was present for this observation and confirmed these findings.


Review of the items in an envelope for the Sterrad unit reflects that the department processes a BI test daily as per the manufacturer guidelines for the Sterrad machine. The facility demonstrates an example of the BI which reflects they are using the Cyclesure 24. Review of the staff documentation reflects that the department does not have an incubator to place the BI into once they come out of the cycle; therefore the documentation reflects that the Microbiology lab reads and documents the outcome of the BI. Review of multiple days reflect that the department takes up to 4 hours to transport the BI to the incubator after a cycle is completed as opposed to " immediately placing the BI in the incubator after the cycle is completed " per the manufacturer guidelines. This was evident on multiple days in January 2014 and February 2014. The department Manager was present for this observation and confirmed these findings.


Interview on 2/28/2014 at 11:23am with a Sterilization technician reveals that she is aware the BI should be placed in the incubator immediately after it comes out of the Sterrad unit, but she is sometimes too busy to leave to department, and must wait for a transporter or volunteer.

Review of the facility ' s policy and procedure titled, " Sterilizers, Monitors, and Control, " revealed the following: Responsible Department: Sterilization Services and Surgical Services; Summary and Purpose: to provide guidelines for personnel to follow while preparing items for sterilization, to validate adequate functioning of the sterilizers), and to ensure that sterile products are the outcome of the sterilization process. This monitoring is also an ongoing component of infection prevention and control; 3) Prevacuum (Dynamic air Removal) Steam Sterilizers; Wrap Cycles, Biological Indicators: 1) all prevacuum steam sterilizers should be tested daily with a process challenge device (PCD) consisting of B. stearothermophilus. The PCD should be placed in the first load of the day in the front and bottom of the steam sterilizer to provide a maximum challenge to the sterilizer; 2) upon completion of the cycle the PCD should be removed from sterilizer and the manufacturer ' s instructions followed for processing and incubation; 3) for those departments using (name of company) Rapid Reader, biological results will be available in 3 hours.


Review of printed documentation from the manufacturer of the Sterrad unit revealed the following: A) set up the biological incubator at 55 degrees Celsius to 60 degrees Celsius according to manufacturer ' s instructions, allowing appropriate time for the incubator to heat up; B) immediately after the Sterrad sterilization cycle, remove Sterrad Cyclesure 24 BI from the sterilizer; c) incubate the processed Sterrad Cyclesure 24 vial at at 55 degrees Celsius to 60 degrees Celsius in the biological incubator.






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2.) Clinical record review of SP#43 conducted on 2/26/2014 revealed a medication order for Lovenox 40 (forty) milligrams (mg) subcutaneously. Nursing Staff (NS)#4 was observed on 2/26/2014 at 10:25 a.m. during the administration of Lovenox. NS#4 was observed to use the hand sanitizer upon entering the patient's room. NS#4 prepared the Lovenox 40 mg and proceeded to administer the Lovenox medication without the use of gloves.

The above finding was confirmed from the Nurse Manager of the 5th Floor on 2/26/2014 at 10:30 a.m. that there was failure of the staff to follow Standard Practice of wearing gloves when administering an injectable medication.