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Based on the findings during a complaint investigation and the associated finding of Immediate Jeopardy and document review, the Governing Body failed to ensure oversight was provided to ensure the services provided by the facility were safe and compliant with the regulations.

This included identification of concerns in the following Conditions of Participation and Standards:
482.21 Condition of Participation - QAPI - A0263
482.21(a),(c)(2),(e)(3) Standard- Quality Patient Safety A0286
482.42 Condition of Participation- Infection Control - A0747
482.42(a)(3) Standard- Infection Control Surveillance and Prevention -A0750

Observations, interviews, document reviews and the concerns identified from an anonymous complaint evidenced an ongoing concern of the proper decontamination and sterilization of surgical instruments since September 2023.

Please refer to:
QAPI - A0263 and A0286
Infection Control - A0747 and A0750 for further information.

Based on observation, staff interview, facility document review and during the course of a complaint investigation, the Governing Body failed to provide oversight to ensure patient safety and infection control concerns were fully addressed and mitigated.

The findings included:

The survey team made observations of sterile and "ready for use" surgical trays of 11/20 and 11/21/23 which evidenced a continuing problem of potential contamination of instruments and use of damaged instruments. The survey team requested to review the Governing Body Meeting minutes from 9/29/23 through 11/20/23. The documents didn't contain any concerns or actions related to the ongoing problem with surgical instrument issues. The only reference was made at the 10/24/23 meeting which stated, "The Board also received an update on our Central Sterile Processes and a recent Virginia Department of Health visit." There was no documentation of what was discussed or any actions or suggestions from the Board.

Numerous interviews conducted during the survey on 11/20/23 and 11/21/23, evidenced staff's concerns related to continuing problems with surgical instrument contamination. The survey team reviewed 544 Safewatch reports (event reports) from 9/29/23 through 11/20/23 entered by staff, all related to surgical instrument issues. Each report documented a single event involving multiple trays related to concerns for potential contamination of instruments and trays.

The facility presented evidence of "diversion" of cardiac patients to other facilities due to not having the instruments available to perform scheduled cardiac surgical procedures.

It was discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m., they would have to respond with a plan of correction for the Conditions of Participation identified.

Based on observation, staff interview, facility document review and during the course of a complaint investigation, the Governing Body failed to provide oversight to ensure patient safety and infection control concerns were fully addressed and mitigated.

The findings included:

The survey team made observations of sterile and "ready for use" surgical trays of 11/20 and 11/21/23 which evidenced a continuing problem of potential contamination of instruments and use of damaged instruments. The survey team requested to review the Governing Body Meeting minutes from 9/29/23 through 11/20/23. The documents didn't contain any concerns or actions related to the ongoing problem with surgical instrument issues. The only reference was made at the 10/24/23 meeting which stated, "The Board also received an update on our Central Sterile Processes and a recent Virginia Department of Health visit." There was no documentation of what was discussed or any actions or suggestions from the Board.

Numerous interviews conducted during the survey on 11/20/23 and 11/21/23, evidenced staff's concerns related to continuing problems with surgical instrument contamination. The survey team reviewed 544 Safewatch reports (event reports) from 9/29/23 through 11/20/23 entered by staff, all related to surgical instrument issues. Each report documented a single event involving multiple trays.

The facility presented evidence of "diversion" of cardiac patients to other facilities due to not having the instruments available to perform scheduled cardiac surgical procedures.

It was discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m., they would have to respond with a plan of correction for the Conditions of Participation identified.

Based on interviews, observations, document review and a complaint investigation resulting in a finding of Immediate Jeopardy for the Condition of Participation 482.42 Infection Control, the facility failed to monitor effectivity of corrective actions related to proper decontamination and sterilization of surgical instruments as outlined in an acceptable IJ removal plan effective 9/25/2023 and implement measures preventing surgical instrument contamination.

On 11/20 and 11/21/23 the survey team observed nine (9) of nine (9) surgical instrument trays which were identified as sterile and ready for use to be contaminated. These observations were witnessed and confirmed by the facility staff who accompanied the survey team on the tour.

The facility's Joint Quality Meeting Minutes didn't contain any evidence of discussion/plan related to the ongoing surgical instrument concerns, patient diversions due to cardiac instruments shortage and contamination issues or any other information addressing the ongoing surgical instrumentation issues.

Please refer to:
A0286 - Patient Safety and
Governing Body - A0043 and A0063
Infection Control - A0747 and A0750 for further information.

Based on interviews, observations and document review and the findings from an anonymous complaint, it was determined the facility's Quality Assurance and Performance Improvement Program failed to adequately address and correct known issues related to inadequate cleaning and sterilization of surgical instruments.

The findings included:

The surveyors requested on 11/20/23 at 3:00 p.m., and received a total of 4 (four) trays to examine which had been processed at this facility and identified as sterile and ready for use. Of the four (4) trays, all had instruments that were visibly contaminated with spots that were easily removable with a gloved finger, dark and light areas of staining, numerous instruments with pitted surfaces, and an instrument with a reddish discoloration. The observations were witnessed by facility staff/leadership.

On 11/21/23 at 12:00 p.m. the survey team requested and received five (5) surgical instrument trays that were identified as sterile and ready for use. Three (3) trays were processed within the facility, one (1) by the outside vendor and one (1) tray was processed in a sister facility. Five (5) of five (5) trays contained instruments with visible pitting, staining, spotting that could be removed with the gloved finger. The observations were witnessed by facility staff/leadership.

The survey team reviewed each of the 544 Safewatch reports (event reports) entered by staff from 9/29/23 through 11/20/23, all related to surgical instrument issues. These reports were single events and involved multiple trays regarding concerns related to contamination of the instruments. In addition, the facility presented evidence of cardiac patients "diversion" to other facilities due to sterile and contamination-free cardiac instrument shortage.

On 11/21/23 at 8:20 a.m., SM #7 stated the facility was in communication with the outside vendor daily and "we send them a list of what we find and what was wrong with the trays. They are supposed to be pulling the instruments that are damaged and giving us a list so that we can replace them...there are five day a week audits of the trays with the team leads and infection control as well as leadership and trays are removed if concerns are found..." SM #7 stated that they observed "a black sooty type of substance" on the bottom of trays, believed to be caused by baskets rubbing on baskets or new pans. SM #7 further stated "we remove any instruments that are of a concern, or trays that do not pass the inspection and determine if the instrument needs replaced or if education needs to be done...we are still having meetings about the water and we are testing...there has been diversion for cardiac surgery because multiple trays were used and no clean trays were available; I don't know how many times."

On 11/21/23 at 9:50 a.m. SM #9 and 10 stated, " Education was done with staff and we talked about the water problems ...instruments are being replaced and some are going off-site for processing..." The SM stated the education provided to staff was regarding visual inspection of instruments and trays, reporting of variances/concerns and pre-cleaning of instruments after procedures prior to decontamination and sterilization.

A staff member #8 (SM #8) stated on 11/21/23 that there are continuing issues and the staff are doing their best to work through them. SM #8 stated that administration/leadership believed that steaming takes care of everything and have developed a policy that puts the OR staff and surgeons at odds regarding the rejection of the trays. "They heard our concerns, but we still have a policy". SM #8 further explained that there have been patients sent to other facilities or rescheduled due to not having instruments available. "The surgeons see what the staff sees...this is a continuing problem..."

The facility policy "Cleaning, Care, Transport of Reusable Instruments/Medical Devices was reviewed and was identified by facility SM #12 as the most recent update. (Last updated 7/21)

The facility policy "Sterile Field, Guidelines for Preparing, Maintaining and Monitoring" was reviewed (effective 11-2023) and was identified by SM #12 as the policy most recently updated and that things were being "reviewed by Quality". This policy evidenced, in summary, that after OR staff visually inspected the trays, if there were concerns about the use, the surgeon "has the ability to over-ride" and the tray could be used. This was the concern expressed that would "put staff at odds".

The survey team reviewed additional policies and procedures, facility event reports (Safewatch), OR logs, Quality, Governing Body and Infection Control Meeting minutes (September through November 2023), selected personnel files for credentialing, orientation, competencies, and education/training, conducted multiple interviews, made pertinent observations of sterile processing as well as observations of surgical instrument trays.

The Joint Quality Meeting Minutes of meeting on 10/19/23 contained no evidence of surgical instrument issues, Safewatch reports, or diversion of patients due to lack of instruments were discussed, addressed or tracked.

The concerns related to the Conditions of Participation and standards identified were discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m.

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

Observations of nine (9) randomly sampled surgical trays on on 11/20/23 (four (4) trays inspected ) and 11/21/23 (five (5) trays inspected) that were identified as sterile and ready for use found all nine (9) trays to contain instruments contaminated with unknown brownish red substance, spots easily removable with a gloved finger, pitting/etching and dark and light areas of staining. Trays included in the survey sample included trays processed by the facility as well as by a third party vendor. These observations were witnessed and confirmed by the facility staff who accompanied the survey team on the tour.

After consultation with the State Agency and CMS and based on the above noted observations, the survey team identified and notified the facility staff on 11/21/23 at 3:23 p.m. of the finding of Immediate Jeopardy (IJ). The serious concerns regarding observed contamination of surgical instruments presenting potential for serious harm and potential for exposure to infections, delay, and/or prolongation of surgical interventions were discussed with the facility leadership. An immediate plan of removal was requested.

On 11/22/23 at 4:53 p.m., the facility presented an acceptable plan of removal. In Summary the plan of removal included implementation of the following immediate corrective actions:
All instruments processed on-site, at sister facilities and by 3rd party vendor will be routinely inspected in the OR prior to use by OR nursing staff. If staff has concerns related to contamination an "in room expert"/instrument specialist (dedicated staff knowledgeable in infection control and prevention who has certification and training in infection control and/or documented experience with surgical instrument decontamination and sterilization practices. ) is called and determines if tray is safe to use. If the instrument specialist deems at least one instrument to have potential for contamination, the entire tray is rejected, photo documentation will be created and report entered in Safewatch. All surgical trays are inspected also at point of use cleaning and visibly defective instruments are removed from trays. In central sterilization all trays are inspected for defects, defective instruments removed, assembled, audited 100% with photo verification. In addition, facility will perform random sampling audits post autoclave daily, conduct real time audits, and administration audits using AORN Guidelines for Perioperative Practice; Sterile Technique Guidelines and ANSI/AAMI standards. The plan of removal detailed the process for "In room Process" (Operating Room tray procedure, observation and inspection). Effective 11/22/23, staff is not permitted to start their shift until they are educated on the new process and signed attestation of understanding.

The facility also agreed to closely collaborate with the state epidemiology survey team specializing in Hospital Acquired Infections and agreed to an infection prevention and control assessment site visit on 12/01/2023 and committed to provide SA with regular updates on corrective actions implementation and monitoring of effectiveness.

The surveyor, on 11/24/23 at 12:00 p.m., after making observations, conducting interviews, reviewing documentation and consulting with the State Agency and CMS, notified the facility of removal of the Immediate Jeopardy however, condition level noncompliance remained.

Please refer to A0750 for further information.

Based on observation, staff interview, facility document review and during the course of a complaint investigation, the facility staff failed to ensure the prevention and potential spread of infectious diseases by monitoring and ensuring the proper decontamination and sterilization of surgical instruments.
The survey team inspected nine (9) surgical trays that were identified as sterile and ready for use. Nine (9) of nine (9) trays observed contained visibly contaminated instruments.

The findings included:

On 11/20/23 between 2:15 p.m. and 3:00 p.m., the survey team, accompanied by facility Administration Staff Members (SM) #4, 5, 6, 7, 9, and #10 inspected four (4) randomly selected surgical instrument trays that were sterilized and identified as ready for use. Two (2) of the trays were processed by an outside vendor and two (2) of the trays were identified as being processed in-house. Four (4) of four (4) trays had visibly contaminated instruments with spots that were easily removed with a gloved finger, dark and light areas of staining, numerous instruments with pitted surfaces, and an instruments with a reddish discoloration. The survey team requested a resi-test** of the discolored instrument.(**Resi-test- a cleaning indicator used after manual or automated cleaning to determine if a medical device is free from protein. Used to detect residual levels of protein on the surface of a surgical instrument, that is not otherwise identifiable by visual inspection. Testing for proteins focuses on certain types of protein commonly present in blood and is an essential part of a hospital sterile services regulatory compliance. (www.steris.com)). The test was performed by facility staff who identified the test result was "positive". The observations were witnessed by facility staff/leadership.

On 11/21/23 at 12:00 p.m. the survey team requested and received five (5) surgical instrument trays that were identified as sterile and ready for use. Three (3) trays were processed on-site, one (1) was processed by third party vendor and one (1) tray was processed at a sister facility. Five (5) of five (5) trays contained instruments with visible pitting, staining, spotting that could be removed with the gloved finger. The trays were processed within the facility and by the outside vendor. The observations were witnessed my facility staff/leadership.

The survey team reviewed each, of a total of 544 "Safewatch" reports, submitted from 9/30/23 through 11/20/23 which identified multiple trays of instruments that were rejected for use by the Operating Room scrub team due to potential contamination. The instruments had been brought into the OR suite and opened for visual inspection prior to surgical cases and contained visible contamination and were rejected for use by the OR staff.

On 11/21/23 at 8:20 a.m., SM #7 stated the facility was in communication with the outside vendor daily and "we send them a list of what we find and what was wrong with the trays. They are supposed to be pulling the instruments that are damaged and giving us a list so that we can replace them...there are five day a week audits with the team leads and infection control as well as leadership. We are ordering new instruments...if a case is deemed contaminated (contaminated wound class per AORN : open, fresh accidental wounds, major breaks in sterility during surgery, spillage from the GI tract, incisions with nonpurulent inflammation), this must be disclosed to the patient (discussion with the patient/RP that instruments used during their surgical procedure were sterilized, but still contained potential areas of concern for contamination. This would be documented in the patient record.) The surgeon would have to put the wound class as contaminated...they (staff) have the opportunity to do the resi-test...a lot of things they call upstairs (OR) does not need to be called...yes we have had issues with galvanic residue and a black sooty type of substance, but we think it may be baskets rubbing on baskets or new pans. The black soot is on the bottom so it is easy to identify...we are till having meetings about the water and we are testing...there has been diversion for cardiac surgery because multiple trays were used and no clean trays were available; I don't know how many times."

On 11/21/23 at 9:50 a.m. SM #9 and 10 stated, " Education was done with staff and we talked about the water problems...instruments are being replaced and some are going off-site for processing...there was a huge influx of Safewatch reports after the training...there are five to seven hundred trays a day (500-700)...I think there has been an improvement since the last time..." The SM stated the education provided to staff was regarding visual inspection of instruments and trays, reporting of variances/concerns and pre-cleaning of instruments after procedures prior to decontamination and sterilization.

The survey team reviewed multiple policies and procedures related to the cleaning and sterilization of surgical instruments and maintaining a sterile field. Also reviewed were employee files for job competencies, as well as facility audits of instruments. Infection Control reports were reviewed as well as meeting minutes. The survey team observed decontamination process "at the point of use" as well as the process of cleaning and sterilization of instruments in the central sterilization which followed the facility policies and procedures. The facility processes a large volume (500 -700 trays/day) containing surgical instruments for numerous specialties, many with a specific manufacturer instruction for use (IFUs). The facility utilizes CensiTrac electronic tracking system for instruments/trays which generates instrument specific IFUs for staff to follow. The surveyors were not provided with audit logs performed as outlined in the removal plan accepted by SA on 9/25/23 and/or any documentation related to additional steps the facility took to remedy the persistent issues with surgical instrument contamination.

On 11/21/23 at 12:00 p.m. the survey team requested and received five (5) surgical instrument trays that were identified as sterile and ready for use. Three trays- General Major, Total Knee and GYN trays were processed on site, Cardiac heart pan II was processed by third party vendor and Coronary tray was processed at a sister facility. Five (5) of five (5) trays contained instruments with visible pitting, staining, spotting that could be removed with the gloved finger. The trays were processed within the facility and by the outside vendor. The observations were witnessed my facility staff/leadership.

It was discussed with the facility during the exit conference on 11/24/23 at 12:15 p.m., they would have to respond with a plan of correction for the Conditions of Participation identified with an acceptable plan of correction which would demonstrate sustainable and long term corrections and monitoring for the deficiencies identified.