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Based on interviews, observations, document review and during the investigation of a complaint, it was determined the facility failed to meet the Condition of Participation 482.21 Quality Assurance and Performance Improvement Program.

The facility's Quality Assurance and Performance Improvement Program failed to monitor the effectiveness of quality improvement activities related to the sterilization of surgical instruments by tracking, trending, analyzing and managing inventory of instruments.

Cross Reference: 482.21 (b), (2), (ii), (c) (3) Quality Improvement Activities

Based on interviews, observations and document review and during the course of a complaint investigation, it was determined the facility's Quality Assurance and Performance Improvement Program (QAPI) failed to monitor the effectiveness of quality improvement activities related to the sterilization of surgical instruments. Facility failure to track, trend, and analyze the condition of surgical instruments, after implementing changes to the sterilization process, resulted in instrument inadequately sterilized and/or in need of replacement and/or repair for three (3) of three (3) surgical trays included in the survey sample.

The findings include:

Review of facility documents

Review of documents provided by On February 21, 2024, Staff #6 provided facility's documents related to reported issues with sterilization of surgical instruments and corrective actions taken. The documents included meeting minutes of the Board of Directors and the Surgery Executive Committee, and the "clinical operations and assessment detail" completed by a third party as well as the following
documents related to monitoring of the implemented changes:
* Ten "Instrument Discrepancy List" dated 1/24 to 2/19/24 - completed by OR (operating room) staff
* Eleven "Turn Over List" dated 1/11 to 2/5/24 - completed by OR staff
* Nine "Case Cart Accuracy Audit Sheets" reviewed found only one sheet dated and none of the sheets with complete documentation - completed by OR staff
* Fourteen "Instrument Set Accuracy Audit Sheets" dated 1/29 to 2/15/24 completed by SPD (Sterile Processing Department) staff
* Eight "Decontamination Observation Audit Sheet" dated 1/30 to 2/15/24 (observation of staff performing decontamination process)

None of the above listed documents include an audit of the condition of surgical instruments (i.e. damaged instruments, pitting, scribing, staining).

Data was collected by OR and SPD staff. The "Instrument Discrepancy List" and the "Turn Over List" capture like data. There is no evidence the QAPI program collected (from SPD and OR staff) and compiled data, completed tracking or trending of data and no evidence of detailed analysis (i.e. type of instruments returned, type of surgical trays, assembler, etc.) to determine the effectiveness of implemented improvement actions, and the need for revisions or additional improvement activities. The facility's lack of tracking, trending and analyzing for surgical trays returned to SPD due to issues with contamination or condition of instruments, failed to provide the information needed to monitor the effectiveness of corrective action and make changes.


Observations

On February 20, 2024, at 1:00 PM, the survey team made observations in SPD where surgical instruments are decontaminated and sterilized. Present during the tour were hospital Staff #10, Staff #13 and Staff #14. After a tour of the area, the survey team asked to inspect 3 (three) randomly selected post-sterilization trays. Inspection of three surgical trays revealed the following:

1. "hand tray basic" processed February 12, 2024, contained clamped retractors, forceps with reddish brown substance, one retractor with deep scratches, one retractor with tape residue, curved scissors with reddish brown stains and tape residue on handles, straight scissors with pitting.
2. "solo set" processed February 12, 2024, contained straight hemostat with brown stain, curved clamp with scribe and retractor with sticky substance.
3. "lap set" processed February 16, 2024, contained two clamps with scribe, forceps with rust, scissors with white sticky substance on blades, retractor dotted multiple brown stains, ribbon retractor with multiple dents and cracks in finish.

Each finding of concern was validated by facility staff accompanying the survey team during the tour. The survey team's findings during inspection of three random surgical trays (noted above) indicate the facility's actions to mitigate identified issues with the sterilization process are ineffective.

Interviews
Staff #12 (Chief Operating Officer (COO)) interview conducted February 21, 2024, at 3:00 PM indicates the facility became aware of issues related to instrument sterilization on October 11, 2023. The facility conducted internal root cause analysis, contracted a third party company for an on-site assessment of SPD based on which the hospital ceased on-site sterilization of surgical instruments through December 6, 2023. The implemented remediation plan included SPD staff training/competency evaluation/assessment by third party company Education Representative and Infection Control Practitioner, restored staff's access to "OneSource" (a web-based platform that allows healthcare staff to access Instructions For Use (IFUs), cleaning protocols, service manuals, and Safety Data Sheets (SDS)), installation of three new low temp sterilizers and employment of an Interim SPD manager and Interim OR (operating room) Director.

Staff #11, (OR Charge Nurse) interview conducted February 21, 2024, at 2:40 PM indicates they first noticed an increase in issues with surgical trays in early fall, recalling surgical trays not having locks on the outside or with sterilization indicators missing. Findings of damaged or contaminated instruments at that time were verbally reported to their department director or the person overseeing SPD. Staff #11 indicates that for about the last 2 weeks the reporting process has changed, and they have been completing "Case Cart Accuracy Audit Sheet" which are returned to SPD with each "dirty" cart.

Staff #10 (contracted to help implement changes and to mentor Staff #13 (SPD Lead)), interview conducted February 21, 2024, at 3:15 PM indicates that instruments that have pitting, gouging, or denting cannot be adequately sterilized. After the survey team identified damaged instruments on 2/20/24, staff were instructed (in a 3:00 PM huddle) to pull all damaged instruments out, even if they can't complete the set and stated that "we may have some surgeries that need to be rescheduled" until instruments can be replaced. Staff #10 indicates they (Staff #10 and Staff #13) round "a lot" to observe proper processes are being followed, look at key performance indicators and review case cart accuracy audits. "Case Cart Accuracy Audit Sheets" are completed by OR (operating room) staff before the case. No process is in place to ensure "Case Cart Accuracy Audit Sheets" are completed by OR staff and returned to SPD with each "dirty" cart. Identified as "key performance indicator" the audits are the final quality check before instruments are used. They (Staff #10 and Staff #13) audit about 5 (five) surgical trays per week using the "Instrument Set Accuracy Audit Sheets" .

Staff #3, indicates in an interview on February 22, 2024, at 9:30 AM, that Infection Prevention Department involvement in the SPD process improvements includes participation in leadership environmental rounds and providing some education and teaching aids in SPD. Infection Preventionist do not currently conduct audits in SPD or do walk through's to observe staff's infection control practices.

Staff #9, Market Director of Quality, indicates in an interview on February 22, 2024, at 10:30 AM, that the facility became aware of issues related to instrument sterilization on October 11, 2023. After conducting a root cause analysis, they reviewed policies, purchased new surgical instruments, tasked Environmental Services to daily terminally clean of SPD, hired/contracted additional staff for SPD and contracted installation of SPM (surgical instrument tracking system) which is anticipated to be active in April-May 2024. Staff #9 indicates problems related to surgical instrument sterilization should have been identified earlier, prior to the resignation of the Director of Surgical Services on November 22, 2023.

The facility's failure to provide oversight to monitor the effectiveness of the improvement activity is evidenced by the surveyors' adverse findings in all post-sterilization trays included in the survey sample on February 20, 2024.

Based on interviews, medical record review and hospital document review, the facility a) failed to complete neurological checks as ordered by the physician and b) failed to complete nursing assessment per policy for one (1) of three (3) patients included in the survey sample. Patient #5.

The findings included:

A review of medical records was conducted on February 22, 2024, with the assistance of Staff #17.
Patient #5 was admitted to the hospital on March 24, 2023, with an admitting diagnosis of Altered Mental Status (AMS) and remained as in inpatient until discharge on April 7, 2023.

a) Failure to complete neurological assessments per provider's order
Review of facility policy, "Neurological Assessment and Documentation", expiration date 02/2027, revealed, in part: "focused neurological assessments include, level of consciousness, horizontal eye movement and motor function"... "document assessments in Admission, Shift, or Focus Neurological Assessments as appropriate."

Review of Patient #5's medical record between the dates of April 1, 2023, through April 7, 2023, indicated there was an active order for neurological checks to be completed every fifteen minutes. Staff #17 verified there was no documentation neurological checks were completed during this time.

b) Nursing assessment not completed per hospital policy:
Review of facility policy, "Patient Assessment/Reassessment", expiration date 05/2024, revealed, in part: "a complete assessment is performed by the nurse each shift." When asked about nursing assessments SM #16 explained that there are two shifts in a 24-hour period. 7:00 a.m. to 7:00 p.m. and 7:00 p.m. to 7:00 a.m., and that a patient is to be assessed at least once per shift.

Review of Patient #5's medical record revealed nursing assessments had not been completed each shift as required by hospital policy. The medical record revealed a nursing assessment was completed at 9:13 AM on March 31, 2023; no nursing assessment was completed for the 7:00 PM to 7:00 AM shift. On April 5, 2023, a nursing assessment was completed at 8:00 PM, and no nursing assessment was completed for the 7:00 AM to 7:00 PM shift.

Based on observation, interviews, document review and during the course of a complaint investigation, the facility failed to prevent and stop potential spread of infectious diseases to patients receiving surgical services by not monitoring and ensuring the proper decontamination, sterilization and structural integrity of surgical instruments.

Findings included:

Inspections of three randomly selected sterile surgical trays on February 20, 2024 revealed pitting, scribing, white/brown/reddish stains and sticky residues on surgical instruments and identified additional infection control concerns.

The above noted observations of sterile surgical trays revealed concerns about the proper decontamination and sterilization processes of surgical instruments presenting a potential to adversely affect any patient undergoing a surgical procedure.

Cross reference 482.42(a)(3), The Infection Prevention and Control Program

Based on observation, interview, document review and during the course of a complaint investigation, the facility failed to ensure the prevention and potential spread of infectious diseases by monitoring and ensuring the proper decontamination and sterilization of surgical instruments and removing damaged instruments from inventory.

The findings included:

Review of "Infection Prevention Program 2023" revealed the following in part, Goals: "3. Analyze clinical and operational practices that can possibly affect rates of health-care acquired infections." Authority and Responsibility: "The Infection Preventionist serves as the principal leader of the IP plan at each campus: a. Reports to the Quality Director" ..."c. Has responsibility for developing & implementing policies governing control of Infections/communicable diseases along with coordinating, and directing the program of surveillance prevention and control of infection and associated adverse events as approved by the committee."

On February 20, 2024 at 1:00 PM, the survey team made observations in the Central Sterile Processing (SPD-Sterile Processing Department) where surgical instruments are decontaminated and sterilized. Present during the tour were facility Staff #10 , Staff #13 and Staff #14.
Three (3) post-sterilization trays were randomly selected and their inspection revealed:

1. "hand tray basic" processed February 12, 2024, contained clamped retractors, forceps with reddish brown substance, one retractor with deep scratches, one retractor with tape residue, curved scissors with reddish brown stains and tape residue on handles, straight scissors with pitting.
2. "solo set" processed February 12, 2024, contained straight hemostat with brown stain, curved clamp with scribe and retractor with sticky substance.
3. "lap set" processed February 16, 2024, contained two claps with scribe, forceps with rust, scissors with white sticky substance on blades, retractor dotted multiple brown stains, ribbon retractor with multiple dents and cracks in finish.

Each finding of concern was validated by facility staff accompanying the survey team. Staff #10 confirmed the pitted or damaged instruments should have been removed from the trays before they were assembled. Staff #10 indicated they are a contract employee brought in on January 3, 2024 to help with some known issues in SPD and will be managing the SPD for at least a few months.

On February 20, 2024, at approximately 3:00 PM, Staff #12, indicated the facility became aware of an issue related to instrument sterilization and has implemented changes to address the issue. The surveyor asked to be provided with documentation related to the problem discovered and how the hospital has addressed the issues.

On February 21, 2024, at 9:00 AM, the survey team reviewed documentation related to improvement actions including meeting minutes of the Board of Directors and the Surgery Executive Committee, and the "clinical operations and assessment detail" completed by a third party. Hospital administration was made aware of the issue with the surgical instruments on October 11, 2023, by an orthopedic provider. On October 12, 2023, hospital staff conducted a RCA (root cause analysis) investigation into the provider's concern. Based on the findings of the RCA, a third party, company specialized in surgical sterilization management was contacted on October 13, 2023, to complete an on-site assessment of SPD. The third party conducted the assessment November 6-10, 2023, and based on their findings, the hospital stopped the on-site sterilization of surgical instruments and an off-site instrument processing was implemented immediately. On-site processing of instrument resumed on December 6, 2023, after completion of SPD staff training, competency evaluation/assessment by and installation of three new low temp sterilizers.

The Director of Surgical Services, resigned on November 22, 2023. The COO (Chief Operating Officer) is providing oversight of the implementation of corrective actions.

Staff Member #10 indicates in an interview on February 21, 2024, at 3:15 PM, they had been contracted to help implement changes and to mentor Staff #13 (SPD Lead). Until two weeks ago staff would report any instrument issues verbally to leadership of surgery department or SPD; currently OR staff completes a "Case Cart Accuracy Audit Sheet" and returns it to SPD with the "dirty" instrument cart. Staff #10 indicates they round "a lot" to observe proper processes in OR and SPD are being followed, look at key performance indicators and review "Case Cart Accuracy Audit Sheets". Presently, there is no process in place to ensure audits of trays in SPD are completed and returned. After the survey team identified damaged instruments on February 20, 2024, staff were instructed (in a 3:00 PM huddle) to pull all damaged instruments out, even if they can't complete the set and stated that "we may have some surgeries that need to be rescheduled" until instruments can be replaced.

In an interview on February 22, 2024, at 9:30 AM, Staff #3 indicates the role the Infection Prevention Department has in the SPD process improvements. Infection Control Practitioner's participate in leadership environmental rounds and have provided some education and teaching aids in SPD. Staff #3 indicates they do not currently conduct any additional infection control observations, monitoring or audits in SPD. Monitoring by infection prevention has not been increased or added since the facility became aware of issues related to the sterilization of surgical instruments

The identified issues with condition of surgical instruments included in the survey sample indicate a systemic problem. The infection control program failed to provide oversight of the sterilization process and the implemented changes and is not conducting analysis and/or necessary revisions of improvement actions.