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Based on observations, staff interviews, and documentation, the infection control officer:

a. failed to monitor compliance with infection control policies and procedures, and

b. failed to to ensure infection control procotols followed manufacturers' instruction for use.


Findings:


On 06/10/2016, surveyors toured the Operating Room (OR), the following observations were made.


1. The endoscopic reprocessing staff told surveyors they disinfected esophageal dilators in an automatic endoscopic reprocessing (AER) washers. According to the AER manufacturer, washers were only intended to be used to reprocess endoscopes, not dilators. Surveyors observed an adaptor that was used to process the dilator in the washer. The dilator used was not produced or supplied by the manufacturer.


On 06/10/2016 at 1:00 pm, the surveyors contacted the regional representative for the AER washers manufacturer via telephone. The AER representative told surveyors the company only authorized endoscopes, not dilators to be reprocessed in the model of washer used by the facility.


2. On 06/10/2016 surveyors toured the Operating Room (OR). Surveyors observed a desk area in the sterile supply room. The desk had numerous piles of paper, two computers, a container of pencil/pens, and tape. Office supplies can't be cleaned and disinfected.


3. The surveyors reviewed immediate use steam sterilization (IUSS) logs from March 2016 to June 2016. Multiple entries did not contain the name of the patient on which the instrument was used, and/or the reason for processing the instrument by IUSS. Numerous entries listed "Minors" as the type of instrument being processed. The OR manager stated "Minors" on the log indicated that Olympus endoscopic water bottles were being processed.


The hospital policy titled, "Documentation of Immediate Use Steam Sterization 11/2015" documented' "flash autoclaving shall include printout, chemical indicator, patient label, what and why ..."

Based on policy and procedure review, medical record review, and staff interveiw, the hospital failed to:


a) provide adequate number of licensed nurses to provide patient care during surgical procedures.

b) ensure an RN was immediately available for "bedside care" for patients who received moderate sedation.

This occurred in 7 of 7 (Patient #7, 17, 19, 20, 23, 30, and # 32) medical records reviewed.


Findings:


A hospital policy titled, "Moderate Sedation" documented a minimum requirement of 2 (the physician and a registered nurse) persons during procedures that required moderate sedation. The policy further documented the nurse "may not engage in tasks that would compromise continuous monitoring during the procedure."


The policy failed to identify the licensed personnel responsible for:

~Observation of hand hygiene and incidental contamination.

~Fire risk assessment.

~Ensuring all staff wear proper person protective wear and surgical attire.

~Proper use of the electrocautery unit.

~Availability of proper supplies and accessories.

~Safety check of the environment, including fire safety, identification of electrical hazards, availability of medical gases.

~Availability of emergency equipment.

~Specimen labeling and the completion of the pathology requisition(s).


Seven of seven (Patient #7, 17, 19, 20, 23, 30, and # 32) ) medical records reviewed, of patients who required moderate sedation, documented the personnel in the procedure room were the physician, a registered nurse, and an unlicensed tech.


The Operating Room (OR) manager told the surveyor the staff present during moderate sedation were the physician, a registered nurse, and an unlicensed tech.

Based on staff interview and medical record review, the hospital failed to ensure medical records clearly identified what staff provided and documented the care in the record.


Findings:


On 06/13/2016, the surveyors reviewed thirty-two open and closed medical records. Multiple initials only (no staff name) were documented without an accompanying legend of who the staff were. Multiple staff entries of intials only were written on signature lines. Staff C and Staff EEE confirmed this finding at the time of record review.

Based on observations, staff interviews, and documentation, the infection control officer:

a. failed to monitor compliance with infection control policies and procedures; and

b. failed to to ensure infection control procotols followed manufacturers' instruction for use.


Findings:


1. On 06/08/2016, the surveyors toured the Sleep Study Laboratory. This department performed sleep studies for approximately 50 patients per month. The studies performed required a patient to wear a facemask. Multiple facemasks were seen laying on a towel uncovered.


The respiratory therapy director told the surveyors the masks were used by patients during the sleep studies. The respiratory therapy director told the surveyors after each patient use, the masks were washed with soap and water, wiped with a disinfection cloth, and placed on the towel.


Surveyors reviewed the manufacturer's instruction for use document, "ResMed Disinfection and sterilization guide." The manufacturer's instruction for use documented the masks were intended for multiple patient use and should be reprocessed by high level thermal or chemical disinfection or by sterilization.


2. The endoscopic reprocessing staff told surveyors they disinfected esophageal dilators in automatic endoscopic reprocessing (AER) washers. According to the AER manufacturer, washers were only intended to be used to reprocess endoscopes, not dilators. Surveyors observed an adaptor that was used to process the dilator in the washer. The dilator used was not produced or supplied by the manufacturer.


On 06/10/2016 at 1:00 pm, the surveyors contacted the regional representative for the AER washers manufacturer via telephone. The AER representative told surveyors the company only authorized endoscopes, not dilators to be reprocessed in the model of washer used by the facility.


3. On 06/10/2016 surveyors toured the Operating Room (OR). Surveyors observed a desk area in the sterile supply room. The desk had numerous piles of paper, two computers, a container of pencil/pens, and tape. Office supplies can't be cleaned and disinfected.


4. The surveyors reviewed immediate use steam sterilization (IUSS) logs from March 2016 to June 2016. Multiple entries did not contain the name of the patient on which the instrument was used, and / or the reason for processing the instrument by IUSS. Numerous entries listed "Minors" as the type of instrument being processed. The OR manager stated "Minors" on the log indicated that Olympus endoscopic water bottles were being processed.


The hospital policy titled, "Documentation of Immediate Use Steam Sterization 11/2015" documented' "flash autoclaving shall include printout, chemical indicator, patient label, what and why ..."