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Based on interview and document review, the hospital failed to meet the requirements at 42 CFR 482.12 Condition of Participation for Governing Body.

Failure to meet minimum infection control program requirements for training , oversight and quality assurance resulted in an unsafe healthcare environment for outpatient surgical and clinical patients.
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Findings:

Due to the scope and severity of condition-level deficiencies detailed under 42 CFR 482.42 Condition of Participation for Infection Control; and standard-level deficiencies under 42 CFR 482.41 Condition of Participation for Quality Assessment and Performance Improvement, the Condition of Participation for Governing Body was NOT MET.


Reference: A0286; A0747

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Based on interview and record review, the hospital failed to establish an expectation of safe practices for processing of reusable surgical instruments decontaminated and sterilized at their outpatient surgical facility.

Failure to establish an expectation of safe practice guidelines for sterilization of surgical instruments at all hospital campuses puts patients at risk of infection from improperly cleaned and sterilized instruments.

Findings include:

1. On 9/9/2015 at 9:00 a.m., Investigator #2 conducted a survey with administrative staff members about events that led to the discovery of a breach of standard decontamination and sterilization practice occurring at the hospital's outpatient surgical facility. Staff members revealed that on 8/10/2015, an outside vendor completed a routine inspection of a sterilized cannulated screwdriver. Once the instrument was returned to the department for reprocessing, a hospital staff member noticed the presence of debris coming from the screwdriver as it was flushed with water. The employee reported the observation to his/her supervisor, who in turn, notified the Human Resources department.

Hospital staff members inspected 9 additional surgical sets from the same facility and observed 6 of 9 sets with anomalies consistent with a deviation of standard practice for reprocessing of the instruments including: water marks left on instruments, a small bit of paper retained at the bottom of one set.

2. Hospital administrative staff interviewed a sterile processing technician( SPT #1) (date unknown) about cleaning of instruments prior to sterilization. SPT #1 indicated that s/he did not employ standard practices (opening of hinged instruments, individual washing of all items in the set) if the items had not been used in the surgical case.

3. On 8/20/2015, the hospital discontinued all reprocessing of surgical instruments at the outpatient surgical facility, and collected and reprocessed all instruments from the facility at the hospital's main campus sterile processing department.

4. On 8/24/2015, hospital administrators also performed a "process walk", which included direct observation of staff members at each step of instrument reprocessing. During this observation and through additional interviews, the hospital administrators identified a second Sterile Processing Tech (SPT #2) at the outpatient surgical center, with breaks in standard practice of decontamination of surgical instruments.

5. On 9/9/2015 at 8:45 a.m., Investigator #2 conducted an interview with the following hospital staff members: Administrative Staff members, Chief Nursing Officer, Director of Infection Control, Medical Director for Infection Control, Director of Accreditation and Regulatory Compliance, Vice President Perioperative Services and Surgical Service Lines, Director of Surgical Service Line and Transplant Department of Surgery, Senior Vice President and Chief Medical Officer and Medical Administration, Senior Vice President of CPI and Vice President of Facilities and Supply Chain.

The administrative team stated the hospital was in the process of conducting an investigation and currently it was not known how the deviation in the practice standard for the sterilization process of surgical equipment went unnoticed. The team could not determine the length of time this failed practice occurred. The Vice President of Perioperative Services and Surgical Services Line stated the hospital's outpatient surgical facility had experienced changes in management that included oversight of the facility's sterile processing staff.

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Based on interview and record review, the hospital failed to provide infection control education and ongoing training to all staff members. The hospital also failed to monitor staff members for compliance with standard practices of sterile processing.

Failure to educate and monitor staff members who perform surgical instrument reprocessing away from the main campus, put surgical and clinical patients at risk from of healthcare acquired infections from contaminated and improperly sterilized instruments.

Findings include:

1. Interviews with administrative staff indicated they are unaware of how deviations in standard practice for reusable surgical instrument reprocessing occurred at the off-site facility.

Reference: A0286

2. The hospital failed to include initial and ongoing infection control training for all staff members, that included job-specific competencies designed to minimize the risk of infection for patients.

Reference: A0756
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Due to the scope and severity of deficiencies identified under the Condition of Participation at 42 CFR 482.42, the Condition of Participation at 42 CFR 482.42, Infection Control, was NOT MET.
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Based on interview and record review, the hospital failed to ensure hospital-wide quality assessment and performance improvement including education and training, were implemented at all hospital campuses.

Failure to provide education and oversight of sterile processing staff members at the offsite campus allowed them to perform the sterilization of surgical instruments without supervision, monitoring or necessary education to prevent potential infection of surgical patients.

Findings include:

1. On 9/10/2015, Investigator #2 reviewed the following personnel records:

a. Sterile Processing Technician #1: The hire date for this staff member was 5/7/1996. The hospital failed to provide documentation in the staff member's record to support that s/he had received ongoing infection control training, competency evaluation, monitoring or supervision while working as a Sterile Processing Technician. The hospital had also asked this staff member to mentor new employees.

b. Sterile Processing Technician #2: The hire date for this staff member was 4/22/2013. The hospital failed to provide documentation in the staff member's record to support that s/he had received ongoing infection control training, competency evaluation, monitoring or supervision while working as a Sterile Processing Technician.

2. On 9/10/2015 at 2:00 p.m., Investigator #2 conducted interviews with the manager of Human Resources Consulting, Human Resource Consultant, and surgical service staff members. Review of documentation revealed a lack of supervision, monitoring, job-specific Infection Control education and department interface between the main campus and the sterile processing staff at the outpatient surgical facility.

3. On 9/10/2015 at 2:15 p.m., the investigators interviewed the Director of Accreditation and Regulatory Compliance. S/he indicated that not all staff members' job descriptions required infection control training specific to their job description. The investigators observed that there was no requirement for specific initial or ongoing infection control training for the Sterile Processing Technician job classification.