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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, it was determined the facility failed to meet the Condition of Participation 482.21 Quality Assurance and Performance Improvement Program.

Findings include:

Facility staff failed to adequately address and correct known issues related to ineffective cleaning and sterilization of surgical instruments.

Facility staff failed to provide evidence of the analysis/investigation of reports of ineffective cleaning and sterilization of surgical instruments at this facility.

Facility staff failed to have a procedure in place to track, trend and analyze the return of surgical instruments for quality and infection control purposes.


Please refer to A0286 for further information.

Based on interviews, observations and document review, it was determined the facility's Quality Assurance and Performance Improvement Program failed to a) adequately address and correct known issues related to inadequate cleaning and sterilization of surgical instruments, b) failed to provide evidence of the analysis/investigation of reports of ineffective cleaning and sterilization of surgical instruments at this facility and c) have a procedure in place to track, trend and analyze the return of surgical instruments for quality purposes.

The findings include:

On 10/12/23 at 9:45 a.m., the surveyor entered the facility. During the entrance interview Staff Member (SM) #5 stated they had been expecting this visit as they were aware of sterilization issue findings at their sister facility (receiving contaminated surgical trays processed at this facility). At 10:45 a.m., a tour was conducted in the Central Sterile Processing (SPD- Sterile Processing Department). The surveyor was accompanied by SM #1 (Manager OR-SPD), SM #2 (Nursing Director Surgical Services), and SM #3 (Infection Preventionist). The surveyor observed the sterilization process and questioned SM #8, #9, and SM #28 about the process, their annul training and any recent training or in-service they received. The surveyor was informed SPD staff had been some assigned CBL (computer based learning) but no observations of practice or skills check has been conducted.

SM #3 was asked about the infection control process for monitoring the SPD's adherence to policy and procedure. SM #3 stated, prior to "last week" they had conducted monthly walk through with checks of the log books and checking of "peel pack" (a disposable sterilization pouch). SM #1, SM #2 and SM #3 were asked if additional interventions had been put into place given the knowledge trays processed at this facility were determined to be contaminated when received by the sister facility. Since learning of the issue, the facility has implemented audits (with 9 trays audited since 10/2/23) and CBL education has been assigned to staff on 9/26/23 to be completed by 10/22/23. The surveyor was told by SM #25 that 75% of SPD and OR staff had completed the training by 10/16/23. The surveyor inquired if any training or in-service related to the decontamination phase of the process was provided to staff and was told "no".

On 10/13/23 at 1:45 p.m., the surveyor conducted observation/inspection of processed trays in SPD. The surveyor inspected 10 randomly selected processed surgical trays available for use, included in the sample were trays processed for the sister facility. The tray sample included: four (4) Vascular, three (3) Cardiac, one (1) General Major, one (1) Ortho and one (1) Bariatric surgical instrument trays. Of the ten (10) trays, three (3) contained visible gross contamination including reddish brown discoloration that removed easily, unknown black substance easily removed and residue of unknown material that was easily removed by surveyor. The facility staff present also observed and confirmed the presence of the unknown contaminants.

The facility provided to surveyor the facility's safewatch reports related to sterile processing of surgical instruments for the timeframe 4/1/23 to present. Review of the safewatch document found 7 reports related to contamination of surgical trays. All seven of the safewatch reports had been filed between 9/29/23 and 10/10/23, after safewatch education was provided to staff. The reports failed to contain information needed to determine if there was a pattern of events.

The surveyor asked what the process is for tracking the return of contaminated trays/instruments and was informed that if a tray reaches the OR and is found to be contaminated and unusable, the employee who discovers the event is to return the tray to "decontam" and file a "safewatch" (the facility system for management of events), safewatch reports are routed to the appropriate manager for review. If a peel pack (instrument in self-sealing sterilization packets) is found to be unusable by provider,the facility usually gets an email from the provider. In an interview with SM #1, SM #2, SM #3 and SM #13, the surveyor asked how the returned trays are tracked to identify trends, (other than safewatch) as the safewatch reports do not detail, i.e. the load number, sterilizer number or date of sterilization. Staff stated the facility does not currently have "CensiTrac" which electronically tracks surgical instruments but are hoping to have it next year. Staff Member (SM) #1, SM #2, SM #3 and SM #13 agreed that "at the moment we don't have the ability to track and trend returned instruments other than safewatch." On 10/13/23, staff confirmed there is no documentation tracking related to who cleans and assembles trays for the sister facility. The documentation is usually on a "count sheet" or list of instruments to be included in a tray, however for those trays processed for the outside facility no count sheets were included. Trays from the sister facility were treated as a unit and the same instruments were sent back to the outside facility that were received, and no count sheet was needed.

Governing body meeting minutes, Quality meeting minutes and Infection control meeting minutes were reviewed for the last 12 months, and contained no documentation of discussion and/or plans for addressing problems related to inadequate sterilization/contamination of surgical instruments.

Review of facility document "Cleaning, Care, Transport of Reusable Instruments/Medical Devices" effective 6/21, found the following in part: "Adverse events should be reported, documented and reviewed for potential improvement opportunities."

Review of facility document "Infection Prevention &Control Program Annual Plan:" read in part: "...Ensure cleaning, disinfection, and sterilization of medical devices is occurring according to standards" and "Evaluate HLD (high level disinfection) and sterilization compliance according to (facility) policy through routine audits." Routine audits were 1-2 audits per month.

During an interview in the afternoon of 10/13/23, the surveyor discussed with SM #5, SM #25, SM #41, SM #11 and SM #14 the failure of the implemented interventions (computer based learning- CBLs and audits) to address the sterilization/contamination issues. The surveyor's finding of contaminated trays on 10/13/23, (when 6 of 8 SPD employees had completed the CBLs) revealed the interventions are not addressing the problem effectively. The surveyor was told by staff that the interventions were based on the sister facility's survey findings. Staff stated they did not know why they had not been instructed to implement all the interventions that had been implemented at the sister facility and they felt they would probably have been implemented in the future. The surveyor asked if an investigation/analysis had been completed for this facility's surgical instrument/tray contamination issue and if yes, to be provided with the documentation of the investigation. No documentation or other evidence was provided to the surveyor and staff present confirmed they have not conducted a root cause analysis of the ongoing issue at this facility.

Evidence presented above demonstrates the facility's knowledge of the quality issue; the failure to analyze a reported issue related to surgical instrument sterilization; the failure to implement effective interventions, and the failure to have a procedure in place to track, trend and analyze the return of surgical instruments for quality purposes.

Facility staff was given the opportunity to present documents and/or additional evidence on 10/18/23 prior to exit. No additional information was provided.

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 to patients receiving surgical services by monitoring and ensuring the proper decontamination and sterilization of surgical instruments. Observations of sterile surgical trays conducted on 10/13/23 evidenced a concern regarding the proper decontamination and sterilization of surgical instruments which had the potential to adversely affect any patient undergoing a surgical procedure.

On 10/13/23 beginning with interviews at 9:00 a.m. and observations beginning at 1:45 p.m. in the Sterile Processing Department/Central Sterile Services (SPD/CSS), the surveyor observed three (3) of ten (10) surgical instrument trays processed on 10/10/23 (2 trays) and 10/13/23 (1 tray). The trays were inspected and found to be contaminated with unknown black substance, unknown residue, and staining. These observations were witnessed and confirmed by the facility staff who accompanied the surveyor on the tour.

After consultation with the State Agency and CMS and based on the above noted observations, the survey team notified the facility staff on 10/13/23 at 5:09 p.m. of the finding of Immediate Jeopardy (IJ) for the Condition of Participation for Infection Control (482.42). The serious concerns regarding the improper sterilization of surgical instruments and the associated observations of the survey team were discussed. An immediate plan of removal was requested.

On 10/16/23 at 3:00 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 trays at the point of assembly and prior to sterilization will be inspected by SPD designated staff with staff completing cleaning and sterilization of tray. SPD staff will complete documentation of tray validation process in "tray validation attestation" which will be audited by Director of Surgical Services. Infection Preventionist will complete at least five unannounced inspections of SPD per week. SPD Director will conduct daily audits of the process in SPD and report weekly to senior leadership. OR staff will complete tray validation process on 100% instruments and document it on "Tray Validation Attestation". All contaminated tray events will be reported in safety event management system. Effective 10/13/23 at 5:30 p.m., OR and SPD staff was not permitted to start their shift until they are educated on the new process, completed assigned education and signed attestation of understanding. In addition, all decontamination staff will be supervised by team leader to oversee training, skills validation prior to staff working unsupervised.

The surveyor, on 10/18/23 at 3:00 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.

Please refer to 0750 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.

On 10/13/23 beginning with interviews at 9:00 a.m. and observations beginning at 1:45 p.m. in the Sterile Processing Department/Central Sterile Services (SPD/CSS), the surveyor observed three (3) of ten (10) surgical instrument trays processed on 10/10/23 (2 trays) and 10/13/23 (1 tray), The trays were inspected and found to be contaminated with unknown black substance, unknown residue, and staining. These observations were witnessed and confirmed by the facility staff who accompanied the surveyor on the tour. This observation resulted in the finding of Immediate Jeopardy.


The findings included:

The surveyor toured Central Sterile Processing (SPD- Sterile Processing Department) where the surgical instruments are decontaminated and sterilized), on 10/12, 10/13 and 10/16/23. The following is a summary:

At 2:07 p.m. on 10/12/23, during observations/tour of SPD, the surveyor asked SM #3 how they monitored the processing of surgical instruments to ensure compliance with policies/procedures and accepted practice related to infection control. SM #3 stated they monitor log books, do a monthly walk through and a check of "peel packs" (single instruments) for compliance. SM #3 stated since being made aware of the problem at a sister hospital, 2 trays are audited weekly by Infection Control, 2 trays by SPD with one additional audit completed by leadership for a total of 5 trays audited weekly. The surveyor asked SM #1 what training or in-service has been provided to SPD/OR staff after being made aware of the serious surgical instruments contamination findings at the sister facility related to trays processed at this facility. SM #1 stated that staff had been assigned computer based education (to be completed by 10/22/23). The surveyor asked if any "hands on" training or in-service related to the decontamination phase of the process was provided to staff and was told "no".
At 1:45 p.m., on 10/13/23 the surveyor returned to SPD for further observations, the surveyor was accompanied by Staff Member (SM) #1 (Manager OR/SPD, SM #3 (Dir of Infection Preventionist), and SM #2 (Nursing Director Surgical Services). The surveyor requested 10 random surgical instrument trays that had been processed, including trays processed for the sister facility. The sample included the following trays: four (4) Vascular, three (3) Cardiac, one (1) General Major, one (1) Ortho and one (1) Bariatric. Of the ten (10) trays, three (3) contained visible contamination including reddish brown discoloration that removed easily, unknown black substance easily removed and residue of unknown material that was easily removed by surveyor. The facility staff present also observed and confirmed the presence of the unknown contaminants. (Note that 6 of 8 SPD employees had completed the assigned CBL before 10/05/23 prior to the dates on trays found with contamination issues)

On 10/13/23, at 2:21 p.m., the surveyor interviewed SM #33 (RN Scrub/First Assistant). SM #33 was shown areas of concern on two surgical instruments (identified by staff as a needle holder and a retractor) pulled from a vascular tray inspected by the surveyor. SM #33 stated it appeared to them to be some type of residue or bioburden. SM #33 confirmed they would consider the instrument to be contaminated which would contaminate the entire tray and thus would not be suitable for use.

After consultation with the State Agency and CMS and based on the above noted observations, the survey team notified the facility staff on 10/13/23 at 5:09 p.m. of the finding of Immediate Jeopardy (IJ) for the Condition of Participation for Infection Control (482.42). The serious concerns regarding the improper sterilization of surgical instruments and the associated observations of the survey team were discussed. An immediate plan of removal was requested.

The facility policy "Cleaning, Care, Transport of Reusable Instruments/Medical Devices evidenced, in part: "Decontamination of reusable instrumentation/medical deices is the initial and most critical step in breaking the chain of disease transmission...M. Instruments/medical devices should be inspected and evaluated for cleanliness and correct working order after decontamination and if soiled or defective should be removed from service until cleaned or repaired...Q. Documentation of instrument cleaning and disinfection processes should be maintained. 1. Cleaning and decontamination documentation should include: a. date b. time c. Identification of instruments d. Method and verification of cleaning results of cleaning audits e. number or identifier of the mechanical instrument washer and results of the washer efficacy testing f. name of the person performing the cleaning and decontamination g. maintenance of the cleaning equipment. IV. Other Issues/Concerns A. Personnel involved in the handling and reprocessing of contaminated instruments and devices should complete initial education and training and competency validation ...Education and training should be an ongoing process in order to promote a safe environment for patients and staff. B. A quality management program should evaluate the cleaning, decontamination and care of instruments that included monitoring of manual and mechanical cleaning...4. Adverse events should be reported, documented and reviewed for potential improvement opportunities..."

The facility was notified on 10/13/23 at 5:15 p.m. they would have to respond with a plan of correction for the Conditions of Participation identified. The findings were reviewed with SM #26 (CEO) SM #13(Accreditation), #14 (Quality), #25 (System Sr. Director of Quality), #38 (Director of SPD and OR) and #3 (Infection Preventionist).

On 10/16/23 at 3:00 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 trays at the point of assembly and prior to sterilization will be inspected by SPD designated staff with staff completing cleaning and sterilization of tray. SPD staff will complete documentation of tray validation process in "tray validation attestation" which will be audited by Director of Surgical Services. Infection Preventionist will complete at least five unannounced inspections of SPD per week. SPD Director will conduct daily audits of the process in SPD and report weekly to senior leadership. OR staff will complete tray validation process on 100% instruments and document it on "Tray Validation Attestation". All contaminated tray events will be reported in safety event management system. Effective 10/13/23 at 5:30 p.m., OR and SPD staff was not permitted to start their shift until they are educated on the new process, completed assigned education and signed attestation of understanding. In addition, all decontamination staff will be supervised by team leader to oversee training, skills validation prior to staff working unsupervised.

The surveyor, on 10/18/23 at 3:00 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.

Based on observation, staff interview and facility document review, staff failed to follow policy regarding the temperature control in six (6) of six (6) operating rooms (OR).

The findings included:

The surveyors requested and received the temperature and humidity logs for six (6) active Operating rooms (ORs). Surveyor review of the logs, found extended periods of time (in each OR) when OR temperatures fell below 68 degrees. The length of time the temperature was below 68 degrees ranged from a few hours to 6 days. The surveyor requested further information and the facility policy related to OR temperatures.

On 10/18/23, the surveyor interviewed SM #42. SM #42 stated they had noted the variations in the OR temperatures during audits. SM #42 stated the OR staff have the capability to over-ride the system and change the temperature out of the set range but are to record the name of the physician requesting the change in an electronic log. SM #42 stated audits of the log shows staff are not documenting as required and are not returning the temperature to the set parameters. The surveyor asked to be provided with the log but did not receive the log before exit conference.

The policy the surveyor was given "Environmental Parameters and Safety in the Operating Room and Central Sterile Department" effective 04-2023 evidenced, in part: "VI, A, 1. Temperature. a. Operating Room: 68 to 75 degrees Fahrenheit (F).... 3. If the Surgeon requests a room temperature that is outside of the listed parameters, the request will be relayed to the charge nurse. They will make changes and document "as per physician request outside of listed parameters...."

AORN (Association of Perioperative registered Nurses at aornguidelines.org) recommends setting the thermostat between 68 and 75 degrees Fahrenheit.

The surveyor discussed the concerns with facility management prior to exit on 10/18/23.