HospitalInspections.org

Based on document review and interview, the hospital infection prevention and control program failed to employ methods for preventing and controlling the transmission of infections as documented in its policies and procedures in one facility.

Findings include:

1. A. Review of the Infection Prevention and Control Policy, last revised 4/22/2021, indicated the following:
The hospital Infection Prevention Program incorporates the following in a continuous cycle: Reduce risk of acquisition and transmission of healthcare associated infections. Surveillance, prevention and control of infections throughout the organization.
Targeted surveillance of patients at high risk for device related infections are monitored. Clinical data is evaluated for opportunities for improvement. Surveillance results will be submitted monthly, quarterly, or annually to the Infection Control Committee for analysis. Post discharge surveillance is done by: Phone calls to surgeon's offices based on positive outpatient wound cultures collected during the post procedure surveillance period.

B. Review of the policy titled Infection Prevention and Control, last revised 6/26/2018, indicated Hospital associates are responsible for knowing and consistently following infection control practices in order to reduce cross contamination and to decrease the risk of acquisition and transmission of infectious microorganisms.


C. Review of the policy titled Cleaning of Endoscopes and Accessories, last revised 2/1/2021, indicated the following:
Policy Statement: All flexible scopes and accessories will be processed for manual or automatic disinfection according to infection control, professional, and Manufacturers' guidelines after each use.
Quality Assurance: Results will be documented with records maintained in the department.

D. Review of the policy titled Processing and Transporting Soiled Instruments, last revised 4/7/2021, indicated the following:
Procedure: Safely transport soiled instruments from point of use to the decontamination area.
Procedural Areas: The following two-step process will be utilized to transport soiled instruments immediately after use.
Step 1: Safely transport soiled instruments from point of use to the designated soiled area.
Step 2: Safely transport soiled instruments from the designated soiled area to the decontamination area in Sterile Processing Department.

E. Review of the Event Reporting (ERS) Policy, last revised 6/25/2021, indicated the following:
Safety Event Review Team (SERT): An interdisciplinary team that includes physician leaders, nurse leaders, Risk and Quality professionals, Pharmacy leaders and others that meet at regular intervals to review all safety events. Following a thorough investigation that includes the known complication test, the SERT team will discern whether deviations from generally accepted performance standards occurred, assign the final event severity, and determine preventability for each event.

2. Review of Events and their follow-up for 1/1/22 to 4/12/22 indicated that on 2/9/22 the following was reported by Technologist-Sonography/Echocardiographic technologist (TS/ET) C4:
Event ID: DTE17728399: Patient involved: P2. During patient's TEE with MD2 and C4, the TEE probe being utilized was malfunctioning. TS/ET C7 brought a new probe from the echo department that he/she believed to be clean and the probe was used to complete the procedure. Afterwards it discovered that the second probe had already been used in another procedure with a different patient (P3). Equipment was not in it's usual place.

Follow-up was assigned to the department manager, C1/A6, Diagnostic Cardiology Manager, by Risk Manager P3. The status indicated investigation was due 2/17/22 and was complete. The Investigation summary indicated the following: There was a TEE performed on patient P3 and the echo tech in this procedure went to the diagnostic cardiology department and placed the TEE probe down prior to taking it to be disinfected and properly cleaned. C4 took the TEE probe and used it on patient P2. Contributory Factors & Issues Leading to this Event: Human Factors. The echo tech that performed the first TEE should have taken the TEE Probe to be disinfected and properly cleaned immediately following the procedure. Immediate Action Taken: *Assessed/monitored patient *Educated staff . Risk Mitigation Poll & Recommendation lacked evidence of a plan for continued monitoring and/or surveillance of patient P2 and possible high risk for device related infections due to cross contamination. The form was signed and dated as completed by C1 on 2/13/22.

The hospital lacked documentation of investigation reviewed by SERT to discern whether deviations from generally accepted performance standards occurred, assign final event severity and determine preventability.

3. Review of the document titled Event Report #DTE17728399, provided by C1, as evidence of staff education for follow-up of the event, indicated the following: Held a required staff meeting with all echo technologists in attendance to discuss infectious disease processes with TEE probes (2/11/2022). *Discussion of the expectation that the cleaning log in Endoscopy will be filled out appropriately. A patient sticker must be listed for multiple identifiers and all appropriate fields must be filled out by the person cleaning the probe.

4. Review of TEE procedures listed on the DxC procedure log for February 2022 in conjunction with the TEE cleaning logs for February 2022 indicated the following:
a. The TEE logs lacked documentation of TEE probe cleaning/disinfection for probe(s) used in procedures for patient P2 and/or P3 on 2/9/22.
b. The TEE logs lacked documentation of staff having performed tasks per protocol following the re-education on 2/11/2022 as follows:
On 2/15/22 patients #11, #12 and #13 had TEE procedures. The logs lacked stickers for patients #11, #12 and #13.
On 2/16/22 patients #14 and #15 had TEE procedures. The logs lacked stickers for patients #14 (written last name only was indicated without a first name documented) and #15.
On 2/22/22 patient #19 had a TEE procedure. The logs lacked documentation of cleaning the probe for patient #19 (name/sticker not on log).
On 2/25/22 patient #20 had a TEE procedure. The logs lacked documentation of cleaning the probe for patient #20 (name/sticker not on log).

5. The following was indicated in interview on 4/13/22:
Beginning at approximately 10:30 AM, A4, Infection Preventionist, indicated that he/she/IP had not been involved in investigation of the event and/or follow-up for Event ID: DTE17728399. A4 indicated he/she had discussed the event with the physician but did not have documentation of discussion(s) and/or outcomes. A4 indicated the Infection Control Committee (ICC) had not yet reviewed events from the first quarter and therefore did not have documentation of ICC review and/or recommendations. A4 verified the facility had not implemented a follow-up plan to track the at-risk patient for developing signs of infection/complications. A4 verified the February 2022 TEE Cleaning Log did not have documentation of probes cleaning for those used in procedures on 2/9/22 for P2 and/or P3. A4 also verified missing log information.

Based on document review and interview, the facility failed to ensure/provide evidence that all staff were fully vaccinated or exempt for COVID-19 vaccination within 60 days of the CMS (Centers for Medicare & Medicaid Services) January 14, 2022 publication Ref: QSO-22-09-ALL, Revised 4/05/22, and/or in accordance with their protocol.

Findings include:

1. Review of facility protocols for medical or religious exemption from the COVID-19 vaccine, approval/effective date not provided, indicated the following: Employees/staff members seeking exemption from COVID-19 vaccination must submit written requests with supporting documentation. All applications for medical and religious exemption and temporary delay are reviewed by the Exemption Review Committee (ERC), which is a multidisciplinary team including representatives from Human Resources, Ethics, Mission Integration, Infection Prevention and Control, Clinical Physicians, and Associate and Occupational Health. Each request is individually reviewed by the appropriate member(s) of the ERC.

2. Review of CMS January 14, 2022 publication Ref: QSO-22-09-ALL, Revised 4/05/22, indicated the following: Requests for non-medical exemptions, such as a religious exemption in accordance with Title VII, must be documented and evaluated in accordance with each hospital's policies and procedures.

3. Review of the facility vaccination status list of employees/staff indicated employees S11 and S17 had a religious exemptions and contracted employee S21 had an exemption (type not identified on list).

4. Review of vaccination and/or exemption documentation indicated contracted staff S21 was approved for a medical exemption from his/her manager of the contracted agency, the hospital lacked evidence of written requests and/or documentation of requests having been reviewed by the ERC and/or appropriate member.

5. On 4/13/22, beginning at approximately 1:30 PM, Director of Quality A9 indicated the hospital's legal team would not allow disclosure of information related to medical/religious exemptions.