Bringing transparency to federal inspections
Tag No.: A0023
Based on staff interviews, personnel file review, and facility document review, it was determined that the facility failed to ensure that endoscopy staff maintain the required credentials as outlined in the job description for the Senior Endoscopy Technician position.
Findings include:
On 07/14/2025 at 1:32 PM, during a review of Staff (S)15's personnel file, a job description for the position of Senior Endoscopy technician was present in the file. The job description stated, " ... Job Requirements ...Two (2) years of Endoscopy or related experience required. Certificate for Endoscopy Technician required, or one (1) year of additional related experience under the supervision of a Professional Nurse may be substituted for the certificate ...Credential required: ... Endoscopy Certificate ..."
At 1:32 PM, S15's certification in endoscopy reprocessing was requested. The certification document that the facility provided expired on 11/30/2022. There was no updated certification available in the employee's file. The employee was not present on the day of the visit, S10 stated that he/she likely has a current certification, but no documentation was provided to confirm this.
At 1:45 PM, upon interview, S7 confirmed that the documentation provided was an expired certificate, and certification was listed as a required credential.
Tag No.: A0951
Based on staff interviews, personnel file review, and facility document review, it was determined that the facility failed to ensure that 1) the assessment of endoscopy staff during orientation is implemented and documented, and 2) annual department specific competencies are conducted for all endoscopy technicians, in accordance with facility policy and Society of Gastroenterology Nurses and Associates (SGNA) guidelines.
Findings include:
Reference: SGNA Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes, 2023 stated, " ... Personnel. Ensuring consistently effective endoscope reprocessing and safety is a multidisciplinary effort involving clinical and reprocessing staff, infection prevention personnel, and management. SGNA recommends that reprocessing personnel accomplish the following: Understand the rationale and importance of each step in reprocessing; Complete all endoscope reprocessing steps meticulously and efficiently, maintaining strict adherence to the reprocessing protocol; Readily access the manufacturer's instructions for use (IFU); Demonstrate model-specific competency for all steps of endoscope reprocessing as outlined by the manufacturer, including proper use of validated automatic endoscope reprocessing systems and other equipment upon hire, at least annually, anytime a breach is identified, and when updated techniques or new endoscope or reprocessing accessories are introduced ... Complete additional training, updated evaluation and documentation of competency whenever a change in reprocessing guidance is received from the manufacturers' IFUs, regulatory agencies, or guidance from professional organizations ... Complete reprocessing training with documented competency for new models of endoscopes, accessories, valves, and automatic endoscope reprocessors as soon as they are introduced in the facility ... Temporary personnel should not be allowed to clean or disinfect endoscopes in either a manual or an automated reprocessing system until competency has been established and verified ..."
Facility policy titled, "Reprocessing Immersible Flexible Endoscopes With Automated Endoscopic Reprocessor (AER) (last reviewed July 2024) stated, " ... Policy: Endoscope reprocessing shall be performed by staff members who are fully aware of the endoscope's design and the dangers associated with inadequate cleaning and disinfection ..."
1. On 07/14/2025 at 10:09 AM, Staff (S)7 confirmed that the facility follows the Society of Gastroenterology Nurses and Associates (SGNA) Guidelines.
At 10:15 AM, in the Reprocessing room, S13, an endoscopy technician, was observed manually cleaning a contaminated endoscope. Upon interview, S13 stated that he/she has worked in the endoscopy department for over 20 years, however he/she was not certified. S13 stated that they frequently precept new employees, and is currently precepting S12.
When asked about the orientation process, S13 explained that he/she provides verbal feedback to S10 regarding the performance of the employee that is being precepted. S13 stated that in his/her opinion, S12 required additional supervision, and this was communicated to S10, which led to an extension of S12's probationary period. S13 described S12 as receptive to instruction but since S12 has no experience, he/she would benefit from additional training. Upon interview, S13 stated that there was no checklist used during the training that outlines the steps and skills related to the decontamination and high-level disinfection of endoscopes.
At 10:26 AM, upon interview, S12 stated that he/she had been a facility employee for three years and had the role of Patient Services Associate and Transporter. He/she began working as an endoscopy technician four months ago. S12 stated that he/she felt like the orientation process was progressing well, his/her preceptors have been providing "good feedback," but stated that the probationary period has been extended. During the interview, S12 was asked if he/she had been instructed to follow the manufacturer's instructions for use (IFU) when reprocessing endoscopes. S12 replied, "IFUs? I'm not sure what that is." When asked how S12 knows the steps for reprocessing, he/she stated that there is a poster in the decontamination room outlining the steps, and that S13 instructed him/her to follow the poster.
On 7/14/25 at 12:08 PM, a review of personnel files for S12, a newly hired endoscopy technician who had been in the position for two months, and S14, an agency employee who had been assigned to the facility for three months, revealed a lack of documented evidence of a standardized orientation specific to endoscope reprocessing.
Upon request, S7 was unable to provide a specific endoscope reprocessing orientation document. S7 stated that while an employee was on orientation, verbal feedback was received from the preceptor, and a decision was made as to the employee's competency, while using that verbal feedback.
When asked how agency staff are evaluated, S7 stated that the agency provides documentation verifying the competency level and relevant experience.
Upon request at 12:15 PM, S7 was not able to provide department specific orientation and training information for S14.
At 12:20 PM, S10 confirmed that a standardized tool that contains the specific steps required for endoscopy reprocessing was not used for employee orientation.
2. On 07/14/2025 at 12:32 PM, during a review of personnel files for S13, S15, and S16, it was revealed that the 2024 annual department specific competency and evaluation was not conducted for three out of three staff members.
The personnel files of S13 and S16 contained the job description for the position of "Endoscopy Technician." The job description stated, "Essential Duties and Responsibilities ...15. Maintains competency in performing Endoscopy Technician duties safely and effectively ..."
The personnel file for S15 contained the job description for the position of "Sr. [Senior] Endoscopy Technician." The job description stated, "9 ...maintains competency in performing MSP/Endoscopy duties safely and effectively ..."
At 12:30 PM, S10 confirmed that an annual staff evaluation that includes unit specific competencies have not been completed for 2024.