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I. Based on observation, document review and staff interview it was determined the hospital failed to ensure that all dirty instruments/medical devices are properly cleaned/decontaminated with maintenance of surface integrity before being reprocessed. Additionally, the facility failed to ensure the solution used to clean medical devices is mixed and changed according to policy and is performed in a clean environment. This deficient practice was discovered during random observations made on 1/28/13 in the emergency department. Failure to effectively clean instruments/medical devices before reprocessing in a clean environment can result in proliferation of bacteria in environmental areas and instruments which can lead to patient/staff contamination resulting in infections or adverse medical outcomes.

Findings include:

1. Observations in the Emergency Department (ED) on 1/28/13 at 1130 hours revealed a soiled utility room where instruments are cleaned and decontaminated prior to reprocessing. The sink in this room was visibly dirty and heavily stained/discolored. The sink counter top was dirty, stained and worn. In the sink were eight (8) instruments and one (1) stylet which appeared soiled with reddish rusty areas. In a plastic container on the sink were multiple instruments that had large reddish rusty appearing areas. In the same sink behind the faucet were four (4) laryngoscope blades that were soiled with rusty appearing areas scattered over the surfaces. Rusty non intact surfaces precludes effective cleaning.

The emergency department manager who was present, during the tour, stated she had told staff about a week ago to clean those instruments and blades. The manager identified the instruments in the plastic container as being disposable (non-reusable) instruments which should have been disposed of in a separate sharps container that was not in the room.

Review of the current policy for instrument cleaning solution mixing revealed in part the following: Klenzyme solution once mixed is good for twenty-four (24) hours. Amerse solution once mixed is good for seven (7) days.

2. During the same ED tour on 1/28/13 at 1130 hours in the dirty utility were two (2) containers of solution located on top of a counter. One (1) container was marked as containing Klenzyme which was dated as being mixed on 1/16/13 ( twelve (12) days ago). Facility policy specifies this solution is to be mixed every twenty four (24) hours.
The second container was marked as containing Amerse solution that was mixed on 1/16/13 (twelve (12) days ago). The manufactures directions on the Amerse container recommended the solution be changed daily.

The ED Manager who was present, during this tour, agreed both solutions were expired and should have been discarded and new solutions mixed.

II. Based on observations it was determined the hospital failed to ensure the area where instrument resterilization is performed is in a clean space away from patient care with limited employee traffic. Failure to perform instrument resterilization in a clean limited access area can result in contamination of the instruments before, during and after the resterilization process with possible patient exposure to contaminants from instruments/devices resulting in patient infections or adverse outcomes. Additionally, having a steam sterilization unit in high traffic patient care area can result in accidental patient/visitor injury when equipment is accessed by unauthorized individuals.

Findings include:

1. During a tour of the Emergency Department (ED) on 1/28/13 at 1130 hours revealed a table top steam sterilizer located on a three (3) tier cart across from the ED nurses station. All of the shelves on the cart had a heavy layer of dust. Adjacent to the cart were two (2) hallways leading to different areas of the ED. This area is used by both staff and patients. This represents a high risk for contamination of instruments from the environment during the sterilization process. Also, this poses a safety issue to have a steam sterilizer that reaches high temperatures readily accessible by patients including children..

III. Based on document review and staff interview it was determined the hospital failed to follow the Center for Disease Control recommendations that a biological monitor is to be run in all sterilizers at least weekly. This deficient practice was found in the only steam sterilizer in use in the hospital (located in the Emergency Department). Failure to use weekly biological indicators prevents the early discovery of equipment malfunctions or procedural errors and thus minimizing the extent of patient exposure and possible adverse outcomes.

Findings include:

1. Center for Disease Control Guideline for Disinfection and Sterilization in Healthcare Facilities 2008, states in part the following for testing of steam sterilizers:
Steam and low temperature sterilizers should be monitored at least weekly with the appropriate commercial preparation of spores (biological monitor).

During the tour of the Emergency Department (ED) on 1/28/13 at 1130 hours the ED manager stated that biological monitors are run at least weekly in the steam sterilizer in that area.

Review of the instrument sterilization log for the steam sterilizer revealed a biological monitor test had only been run one (1) time in December, one (1) time in November and two (2) times in October 2012. At the time of review on 1/30/13 there had not been any monitors run this month.

The laboratory log for the reading of the biological monitors, was reviewed for October 2012 to present. The laboratory log matched the ED log for when the number and dates of when the illogical monitors were submitted.

The Infection preventionist on 1/30/13 at 1000 hours reviewed the above logs and agreed that biological monitors had not been run weekly in the steam sterilizer as required for several months.

Based on observation, medical record review, policy review and staff interview it was determined the CAH failed to ensure minimum emergency medical requirements were met prior to provision of outpatient Pulmonary Rehabilitation Services. This failed practice impacted one (1) of one (1) patients reviewed who is receiving outpatient Pulmonary Rehab Services (patient #18) and creates the potential for the care and condition of all patients receiving outpatient Pulmonary Rehabilitation services to be adversely impacted.

Findings include:

1. Observation was conducted in the Pulmonary Rehabilitation room at 1340 on 1/29/13.
No standard defibrillator or automated external defibrillator (AED) was observed. An unlocked emergency box was present. Examination of the contents of the box by Respiratory Therapist #1 revealed it contained no medications.

2. Interview was also conducted with the Cardiopulmonary Technician at this time. She confirmed the Pulmonary Rehabilitation area had no defibrillator or AED.

3. Review of a current outpatient patient record (for patient #18) revealed the patient has been receiving Pulmonary Rehabilitation services since 10/16/12.

3. A request for Pulmonary Rehabilitation policies was made. The Technician provided an undated Policy and Procedure manual.

4. Review of undated Policy #48, "Minimum Emergency Requirements," revealed it notes in part: "The Outpatient Pulmonary Rehab Program shall maintain an oxygen source and delivery apparatus...Bag-valve mask device, pulse oximeter, diabetic supplies...first aid supplies, standard defibrillator or automatic external defibrillator, suction equipment, medication: nebulized or meter dose inhaled bronchodilators, glucose, aspirin, sublingual nitroglycerin, cot or stretcher available."

5. These findings were reviewed and discussed with the Chief Nursing Officer (CNO) at 1600 on 1/29/13. She confirmed the Pulmonary Rehab Program had no defibrillator or AED. She stated the emergency equipment and medications would need to be brought to the Pulmonary Rehab room from the nurses station, which is located in another area of the CAH.

6. These findings were reviewed and discussed with the Cardiopulmonary Supervisor at 0810 on 1/30/13. She confirmed the department lacked a standard defibrillator or AED and the medications noted as required by policy.