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Based on observation, interview and record review, the facility failed to ensure the right of Patient 1 to receive surgical care in a safe setting by a qualified personnel. During Patient 1's upper gastro-intestinal (GI)endoscopy (a direct visualization of the digestive tract for diagnostic evaluation and screening, Gastrointestinal Endoscopy, 2009), Staff 2 was observed assisting Physician 1 to perform a biopsy of tissue by tightening the snare in order to cinch it tight around the base of the elevated tissue. The snare is a wire loop and part of the device used for the endoscopy procedure. Staff 2, is a Specialty Technician, Endoscopy III, and there was no documented evidence of his competency to perform the biopsy of stomach tissue in concert with a physician, who was reviewed and approved by the medical staff and governing body of the hospital.

This failure exposed the patient to harm or the risk of harm in being subjected to surgical procedure by the staff that had not been privileged to perform this surgical procedure.


Finding:

On July 21, 2015 at 12:30 p.m., during a follow up visit, a tracer observation was conducted of Patient 1's procedure, endogastrodudoudenoscopy (looking inside the digestive tract). Staff 2 was observed assisting Physician 1 performing a biopsy of tissue during an upper GI endoscopy. The procedure involved closing of a wire snare, a biopsy loop, around a segment of stomach lining tissue identified by Physician 1. Immediately preceding this step, a small amount of saline solution was injected at the base of the identified tissue by means of a long needle instrument. The purpose was to elevate a suspicious area of tissue from the surrounding gastric, mucosal tissue facilitating its being removed. Physician 1 positioned a wire, snare biopsy loop, around the protrusion of tissue. Upon the direction of Physician 1, Staff 2 tightened the snare in order to cinch it tight around the base of the elevated tissue. Next, Physician 1 applied a cutting, electric current to the snare and twisted it in such a manner as to remove the already-cut biopsied tissue. Finally, a small fabric, meshed bag-like device was grasped by the endoscope and inserted into the abdomen. The excised tissue was manipulated into the bag by Physician 1 and withdrawn from the abdominal cavity through the incision in which the endoscope had been inserted.

The closing of the snare, wire biopsy loop constituted a portion of the severing of the tissue specimen from its location in the stomach lining and resulted from the action of Staff 2. When interviewed, Physician 1 agreed the removal of tissue constituted a biopsy and further acknowledged Staff 2 did not have medical staff privileges to do so.

On July 21, 2015 at 2:00 p.m., a review of the personnel file of Staff 2 indicated he was functioning outside of his scope of practice when he participated in the biopsy that was taken in the course of Patient 1's surgical care. There was no evidence of his competency to perform a surgical procedure; specifically, the biopsy of stomach tissue in concert with a physician, who was reviewed and approved by the medical staff and governing body of the hospital.

Staff 2's personnel file indicated "Cook Duette Multi-Band Mucusectomy (a device used for endoscopic mucosal resection in the gastro-intestinal tract) Competency" dated June 1, 2012. The competency dated June 1, 2012, indicated Staff 2 had completed competency in the use of snare:
"Fully rectracts and extends the snare to confirm smooth operation.
Slides the adjustable marker, located in the handle shaft, to establish a reference point indicating full retraction of the snare into the sheath.
Explains how to use grid on the handle to set up reference point to establish thickness of the tissue being excised during procedure."
There was no documented evidence that Staff 2 had completed this specific competency after June 1, 2012.

Staff 2's Job Summary and "Job Responsibilities" dated June 5, 2015, from the "Job Description/Performance Appraisal," indicated the Specialty Technician is under the supervision of the Registered Nurse, assigned to perform technical duties, and assist with procedures. However, assisting with procedures with specific duties, as well as, the use of snare during an upper gastro-intestinal endoscopy were not specified.

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Based on observation, record review, and interview the hospital failed to ensure an infection control program for controlling infections and diseases of patients and personnel was implemented by failing to:

1. Ensure there was no water droplets on the floor from the washed endoscope (flexible tube with a camera at the end) when the staff transported a washed endoscope that was cradled in a towel from the dirty sink to the clean area.

2. Ensure the staff wore his personal protective equipment, a gown that fully covers the neck.

3. Ensure the concentration of enzymatic cleaner in the solution coming from a dispenser was adequate to clean the endoscopes.

4. Ensure the 12 processed instruments (scissors), already wrapped in their peel packs, did not have colored plastic and banding tape which were used to identify the instruments.

These deficient practices exposed hospital personnel and patients to harm or the risk of harm and in particular from surgical-acquired infection.

Findings:

1. On July 21, 2015 at 10:00 a.m., Staff 1 was observed transporting a previously cleaned endoscope across the processing room enroute to begin what he described as a "high level decontamination" process. The endoscope was cradled in a towel from which drops of water from the previous washing was observed to be draining on to the floor of the room.

During an interview at the same of the observation, Staff 1 was questioned about the potential contamination on the floor. Staff 1 stated this was the usual manner in which previously cleaned endoscopes were transported.

2. On July 21, 2015 at 10:00 a.m., Staff 1 was observed with his personal protective equipment (PPE) garment not covering the base of his neck and leaving four to six inches portion of his upper chest exposed. During a concurrent interview, Staff 1 stated this was the usual manner in which he works his PPE while performing his reprocessing duties and was unaware of his exposure to the unsanitary conditions of the area.

A review of the facility's policy and procedure titled, "Resert XL High Level Disinfection Policy: Nursing and Central Processing" indicated to don PPEs when performing the cleaning and disinfection process. PPE included gloves, fluid resistant cover gown and mask with eye shield must be worn at all times.

According to Centers for Disease Control (CDC) on sequence for putting on the gown, fully cover torso from neck to knees, arms to end of wrists, and wrap around the back, then fasten in back of neck and wrist.


3. On July 21, 2015 at 10:30 a.m., a tour of the endoscope reprocessing room was conducted in the presence of two registered nurses. Staff 1 was observed reprocessing endoscope. There was a tank mounted on the wall to which water supply was connected. During a concurrent interview, Staff 1 was asked what was in the tank. Staff 1 stated a solid block of enzymatic detergent was placed in the tank daily. A tube came out of the tank into the sink. Staff 1 was observed placing the endoscope into the sink and began adding the water and enzymatic detergent mixture which was coming from the tank to the sink. When asked regarding the proper proportion of water and enzymatic detergent mixture, Staff 1 stated a representative from an outside contractor who comes in to periodically check the disinfection equipment used for the endoscopes. There was no documentation of the adequacy of the "Optipro Solid Multi-Enzymatic Cleaner " added to the water to ensure appropriate detergent effect on previously used endoscopes.

The manufacture literature indicated the detergent is supplied by "Ecolabs" as "Optipro Solid Multi-Enzymatic Cleaner." This was supplied in a solid, blue colored block which in turn was placed in a dispenser and mixed with tap water. The dispenser then released a solution of the dissolved solute. Per the manufacture literature this was not was intended for use as a high level disinfectant but only as a detergent used to clean endoscopes of any biomaterial from the instrument after it having been used.

4. On July 21, 2015 at 1 p.m., a tour of the central supply of surgical instruments was conducted with the presence of Staff 4. There were 12 surgical instruments (scissors), which were already processed and already wrapped in their peel packs. They contained small pieces of colored plastic, banding tape on the handles of the instruments used to identify the instruments. During a concurrent interview, Staff 4 stated that they had overlook them.

According to Perioperative Standards and Recommended Practices for 2013 of the AORN, "Recommended Practices for Selection and Use of packaging Systems for Sterilization:"
"Recommendation I
1. Packaging systems should be appropriate for items being sterilized. The packaging system should: maintain sterility of package contents until opened; allow sterilant penetration and direct contact with the item and surfaces, and removal of the sterilant."