HospitalInspections.org

Based on concerns identified during a complaint survey conducted 9/19/23 through 9/22/23 and continuing on 9/25/23 through 9/26/23 and the associated finding of Immediate Jeopardy, the Governing Body failed to ensure oversight regarding the services provided by the facility.

This included identification of concerns in the following Conditions of Participation and Standards:
482.13 Condition of Participation- Patient Rights- A0115
482.13(c)(2) Standard- Patient Rights- Care in a Safe Setting- A0144
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
482.51 Condition of Participation - Surgical Services- A0940
482.51(b) Standard- Surgical Services OR Policies- A0951


Findings discovered during interviews and observations conducted on 9/20/23 and an anonymous complaint allegations evidenced a recurrent issues with the proper decontamination and sterilization of surgical instruments since July 2023.

The facility Governing Body failed to ensure oversight and immediate action was taken when the facility became aware of the concerns brought forward by staff on July 13, 2023 and associated numerous "Safewatch" reports were entered by staff between July and September 2023.

Please refer to:
Patient Rights- A0115 and A0144
QAPI - A0263 and A0286
Infection Control - A0747 and A0750
Surgical Services- A0940 and A0951, for further information.

Based on observation, staff interview, clinical record review, facility document review and during the course of a complaint investigation, the Governing Body failed to ensure that the medical staff were evaluating the quality of services and care provided.

The findings included:

On July 13, 2023, based on evidence provided during this complaint investigation, the facility staff reported their concerns related to proper decontamination and sterilization of surgical instruments to the facility leadership.

On 9/20/23 at 9:45 a.m. the surveyor interviewed Staff Member (SM) #22. SM #22 stated there were "consistent" issues with sterilization of surgical instruments for at least four to five weeks which had caused delays and cancellations of surgical procedures. SM #22 stated they had notified Operating Room Leadership and that Medical Director of Surgical Quality had taken the lead on addressing the situation in "the last couple of weeks". SM #22 stated they had noticed a "consistent problem for at least four to five weeks..."

On 9/20/23 at 11:40 a.m., SM #23 (Senior Vice President and Chair of Surgery) stated, in an interview: "We were aware there were concerns for two (2) months...all the cardiac instruments are being processed off-site..."

On 9/20/23 at 1:15 p.m. SM #24 was interviewed and stated, " This problem has been going on for months; not just in (one OR) but in all of them. We have raised concerns multiple times and at one point we went through forty-three (43) trays to get an intact field...all of this has been documented in the facility 'safewatch' system...surgeries were having to be canceled and patients transferred...there were also delays for procedures due to not being able to find clean instruments..."

The surveyor reviewed the Governing Body Meeting Minutes for the past twelve (12) months and found no mention/documentation of these concerns regarding contaminated surgical instruments. The meetings were held every other month, according to documentation. It should be noted that SM #23 Senior VP and Chair of Surgery were included on the member roster of the Governing Body as well as other members of Senior Leadership who attended meetings and had been aware of the concerns related to the surgical instruments since July 2023.

On 9/26/23 at approximately 12:15 p.m. SM #2, 51, 52 and 54 were notified that the above noted issues related to inaction of Governing Body will require robust and sustainable corrective actions, including long-term monitoring to prevent recurrence of the identified deficiencies.

Based on observation, clinical record reviews, staff interviews, facility document review and during the course of a complaint investigation, the facility staff failed to ensure the patients right to receive safe care and the safety of all patients undergoing surgical procedures.

The facility failed to ensure the proper cleaning of surgical instruments which resulted in patients having their surgical procedures canceled, the patient having to be transferred to another facility or rescheduled. This involved eight (8) patients from 8/30/23 through 9/22/23.

According to interviews and document reviews the facility had been aware of the concerns since July 13, 2023.

Please refer to 0144 for further information.

Based on staff interviews, clinical record reviews, facility document review and during the course of a complaint investigation, the facility staff failed to ensure all patients who were scheduled for or underwent a surgical procedure received care in a safe setting. Due to identified issues with contaminated surgical instruments, patients had to have their procedures canceled, rescheduled or patients were transferred to another facility.

The findings included:

On 9/20/23 the surveyors interviewed numerous operating room (OR) Staff Members (SM) that confirmed the issues with surgical instrument contamination has been ongoing for months, is widespread across all ORs and surgical specialties, well documented in the "safewatch" system, reported to upper management and not addressed by the the leadership. SM #22 stated there were issues with sterilization of surgical instruments which had caused cancellations of surgical procedures. SM #24 stated, "...at one point we went through forty-three (43) trays to get an intact field...surgeries were having to be canceled and patients transferred...there were also delays for procedures due to not being able to find clean instruments...they were telling us the situation was due to water but this is not limited to water problems. When you are finding hair, bone fragments, blood and tissue, that is not the water..." SM #28 reported, "...we raised the alarm and so did the (providers) when it began to affect patient cases and our ability to provide safe care..." SM #40 stated, "There have been multiple cancellations and patients rescheduled and we have transferred due to not having the instruments...this has not only been an inconvenience for patients but poses a risk when they have to wait for a procedure...it is bewildering that we had reported this over and over but nothing was looked at until just recently and we are still having problems..."

The surveyor requested a list of all surgical cases which had been canceled, rescheduled, or patients transferred in the last month. The list named a total of nineteen (19) patients from 8/30 through 9/22/23. The surveyor reviewed the medical records of eight (8) patients on the list whose procedure was canceled, rescheduled, or were transferred due to the concerns with contaminated surgical instruments. The following was evidenced:

Patient #4 was scheduled for a procedure on 8/30/23 (Lower lung lobe wedge resection for lung biopsy). The procedure had to be rescheduled and was completed on 9/6/23, eight (8) days later. On 8/30/23 it was documented by a Registered Nurse (RN) that (name of provider) came to the out patient surgery and spoke to the patient and (family) regarding the cancellation of the procedure due to concerns with surgical instrument availability/contamination.

Patient #5 was admitted on 8/27/23 for a *CABG (*Coronary artery bypass graft surgery [CABG] creates a new path for blood to flow around a blocked or partially blocked artery in the heart. www.mayoclinic.org on 1/30/24) to be performed on 8/30/23, On 8/30/23 it was documented in the "Progress Notes- Patient's procedure canceled for today..." The clinical record further documented in the "Attending ICU Progress note: 9/1/23 ...CABG postponed due to OR (operating room) instrumentation issues..." Procedure was completed on 9/1/23.

Patient #6 was admitted on 8/26/23 and had a *CABG scheduled for 8/31/23 due to suspected NSTEMI (non ST elevated myocardial infarction - heart attack). On 8/31/23 it was documented: "Patient's surgery canceled today due to lack of clean instrument pans and contamination issues. Family requests transfer to (out of state facility)..."

Patient #7 was admitted on 8/27/23 with chest pain and severe Coronary Heart Disease. On 8/31/23 at 7:58 a.m. it was documented "An OR (Operating Room) slot opened today so I am adding patient for CABG..." On 8/31/23 at 1:54 p.m. the attending physician documented, "Case was canceled because of issues regarding instrument pack sterilization. Will reschedule after issues resolved."

Patient #8 was scheduled on 9/5/23 for a *CABG due to coronary artery disease. It was documented on 9/5/23 at 9:51 a.m., "(name of provider) to bedside to notify pt of need to cancel today's surgery due to surgical instrumentation issues and R/S (reschedule) to next week..."

Patient #9 had procedures canceled twice. On 9/14/23, the patient was to have a left upper lobe lobectomy. On 9/13/23 it was documented at 11:00 a.m. "Called and talked with (patient). (Their) surgery that was scheduled for tomorrow needs to be postponed..." The procedure was rescheduled for 9/21/23. On 9/21/23 it was documented: "(Name of provider) at bedside. explained case is canceled due to equipment issue..."

Patient #11 was admitted 9/12/23 with left aortic valve cusp vegetation and aortic regurgitation and was planned for a procedure on 9/22/23. It was documented at 9:20 a.m. "At approx 0900 (9:00 a.m.) (name of provider) in to see pt and let (pt) know surgery today would be canceled due to surgical instrument issues. Patient stating (they) wanted to go elsewhere for surgery and (provider) stated they would help set that up for (patient)..." At 9:32 the provider documented "Pt planned surgery canceled today due to OR instrument issues and lack of appropriate equipment. Pt requesting to be transferred to (other facility)."

Patient #12 was admitted 9/18/23 with a NSTEMI (heart attack) and a CABG was planned on 9/22/23. Documentation revealed the procedure was canceled and the patient transferred to (another facility) due to concerns with canceling the procedure versus a late start as a result of multiple instruments not available for use and the inability to get a complete procedure instrument tray.

On 9/25/23 in an interview with SM #29 at 1:10 p.m., the surveyor was informed that two (2) cases were canceled "today" and "yesterday" (9/24/23) there was an "emergency" and the staff had to "go through five (5) trays to get three (3) good ones".

During the on-site survey from 9/19 through 9/26/23, the surveyor discussed with facility staff administrative leaders (Accreditation, Quality, Surgery Chair, President, VP of Surgery, COO, Chief of Quality, Interim VP of Quality, and Med Director of Surgical Quality) the concerns regarding patient care and safety. The facility administration stated they were not aware of any negative "patient outcome".

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 also failed to meet the Condition of Participation 482.21 Quality Assurance and Performance Improvement Program.

Findings include:

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

Staff interviews and document review revealed the hospital's quality program failed to act on reports of increasing problems with contamination of surgical trays by bioburden (blood, bone, tissue, unidentified debris, hair, etc.) and other contaminates.

Staff failed to provide evidence of root cause analysis/investigation of these adverse events.

Nine surgical cases were confirmed through medical record review to have been delayed, rescheduled or transferred between 8/30/23 and 9/22/23 due to lack of sterilized surgical instruments. Review of the 'safewatch' reports found approximately 145 reports related to contamination of surgical trays have been filed since 3/1/23. Review of the "Daily Log" found an additional 55 (fifty-five) reports of contaminated trays.

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 adequately address and correct known issues related to inadequate cleaning and sterilization of surgical instruments.

The findings include:

Evidence the facility was aware of quality issues:

Interviews-
(1) On 9/20/23 at 9:45 a.m., Staff Member (SM) #22 stated there have been consistent issues with the sterilization of surgical instruments for at least 4 to 5 weeks. SM #22 stated they had notified leadership and that Medical Director of Surgical Quality had taken lead in the situation "in the last couple of weeks".

(2) On 9/20/23 at 11:40 a.m., SM #23 confirmed in an interview having knowledge of the concerns for two (2) months. SM #23 stated there have been issues with water filters being discolored and surgical instruments in the cardiac OR (operating room) with discoloration and spots and some staining and rust on instruments. SM #23 stated, "The wrap has been intact and the indicators were checked" ... "The circulators and nurses are checking the trays and the majority are spots or corrosions on hinges but it is treated as contamination". SM #23 stated "we did have one tray with some suture material and one with an alcohol pad and a few specks of blood". SM #23 stated they are looking into why they were getting spots, the types of instruments and engaging specialists to assist. Infectious Disease/Infection Control was looking into that and the water concerns as well.

(3) On 9/20/23 at 1:15 p.m., SM #24 was interviewed and stated the problem has been going on for months, in all operating rooms and documented in the facility 'safewatch' system. SM #24 stated over 120 safewatch reports have been filed and then staff were told not to report but take pictures. SM #24 stated there are additional concerns related to use of PPE (personal protective equipment) and the use of wire brushes and alcohol on surgical instruments and "there was no move to address anything until last week when they began to slowly address it but we are still having a serious problem..."

(4) In an interview on 9/20/23 at 3:00 p.m., SM #30 stated they have reported the problem over and over and are repeatedly told it is a water problem. SM #30 stated that some of the issue may be a water problem but there is a serious problem of bioburden (bacteria on a surface), blood, bone fragments, hair and trash on the trays. Stating staff have to go through multiple trays to get one that is clean, it doesn't matter what it is; staff do not know if it is water or corrosion or blood when they are in the OR and they will continue to reject trays that are suspect or visibly contaminated. SM #30 stated "This is a continuing problem that has not been addressed because we are still getting contaminated trays... the staff are experienced and have never seen anything like this... there is the occasional un-useable tray but this is every day and multiple trays..." SM #30 stated they have found contamination on trays from multiple areas. When asked if they are aware of any changes being implemented, SM #30 replied they have been asked to tag instruments of concern.

(5) Staff Member (SM) #28 was interviewed on 9/20/23 at 3:40 p.m. and stated contaminated trays had been found "here and there"..."maybe 1 tray" before but in July there was a definite increase in volume, "opening multiple trays for multiple patients,...not just cardiovascular trays (CVI) but trays pulled from other areas were also contaminated. SM #28 stated "they" (management) tried to tell the nurses it is "sterile staining" but no one had provided any evidence of what "sterile staining" is and stated it is more than a water or steam issue. "I have seen instruments that have obvious bioburden in areas where bioburden would reasonably not be".

(6) Staff Member (SM) #39 was interviewed on 9/21/23 at 9:25 a.m. and stated they were made aware of the concerns with the instruments at the end of July-first of August and the concerns fit no clear pattern. SM #39 stated they became more involved the last two weeks at the request of CEO to take the lead. SM #39 stated staff have been instructed to remove any stained or discolored instruments, audits are in place to look at trays before they go to the sterilizer and they look good before the sterilizer but there is a problem with spotting and discoloration after processing. Stating they have brought in specialists from Virginia Tech for water quality, and have moved sterilizing of cardiovascular instruments off-site (to sister facilities). SM #39 stated a team meets daily to discuss work flow needs and logistics related to transporting of trays. SM #39 stated they are working with an expert on sterilization and disinfection from the CDC. SM #39 was asked what was put into place regarding the observations of blood, trash and bone fragments found in sterilized trays. SM #39 replied the trays are being audited by SPD (Sterile Processing Department) staff and OR staff are the final check to make sure no questionable instruments get to the patient. SM #39 was asked if they have been looking at all areas; SM #39 answered "We haven't been as focused with other areas."

(7) SM #40 was interviewed at 12:30 p.m. on 9/21/23 regarding concerns of contamination and the inability to feel they are providing safe care to patients needing surgical intervention. SM #40 stated "We have been telling them (leadership) this for about the last six (6) weeks or more and we were told we were reporting too much or that it was not contamination but a water issue. SM #40 stated their professional experience and "I know the difference between a water spot and dried blood...nothing was done until cases were canceled because we did not have the instruments to be able to get an intact field (having all the sterile instruments necessary)." SM #40 stated, we were told that staff needed re-education on what actually was contamination; further stating "there has been a failure of leadership because we have told them and reported this but nothing was done.."

All the above interviews confirm the hospital quality program had knowledge of problems related to the sterilization of surgical instruments.

Observation-

On 9/20/23 at 1:45 p.m. they survey team made observations in the Central Sterile Processing (SPD-Sterile Processing Department) where surgical instruments are decontaminated and sterilized. The surveyors were accompanied by SM #7, SM #18, SM #54, SM #31, SM #21 and SM #16. The survey team completed random inspections of 4 (four) surgical instrument trays processed that day (9/20/23). Two (2) General Major, one (1) Neuro, and one (1) EP (Electrophysiology) were inspected. Three (3) of the four (4) trays contained visible contamination of reddish brown discoloration (easily removed by a gloved finger), spots and staining of unknown material and one tray contained a yellow piece of what was identified as a candy wrapper inside the sterilized tray. The observation was confirmed by facility staff accompanying the survey team.

Document review-

The surveyor was provided with the facility's "safewatch" reports related to sterile processing of surgical instruments since 3/1/23, and a copy of the "Daily Log" from 9/13/23 to present (staff were told to stop reporting via safewatch and instead call the OR desk and have the issue logged - see interview #3). Please note the surveyors analysis is based on the information the facility was willing to provide to the survey team. The surveyor did not have access to and was not provided with a breakdown of data collected, the following analysis is the result of a manual extraction of data from provided documents. The surveyor requested but was not provided with documentation of any investigation or analysis of the safewatch reports by the quality department.

Review of the safewatch document found approximately 145 reports related to contamination of surgical trays have been filed since 3/1/23. Types of contamination documented included but were not limited to: hair, blood, bone, bioburden, holes in paper wrapping, trash (i.e. alcohol swab, sutures, cement), etc. The surveyor noted an increase in safewatch reports beginning in May 2023, with an increase in the number of days with reports filed, the number of reports and the number of trays affected on nonconsecutive days. This was an increase compared to April which had 9 (nine) reports with 9 (nine) impacted trays over 6 (six) nonconsecutive days. The reports increased each month, peaking in August with reports filed on 21 days, 36 reports filed affecting at least 80 trays. Between 9/1/23 and 9/20/23 reports have been filed on 10 days, with 24 reports affecting at least 55 trays. A significant increase in reports of bioburden was noted in August when it more than doubled. Review of safewatch document found 9 (nine) patients whose procedures were delayed and 4 (four) patients whose procedures were canceled; a list of cases (provided by staff), canceled rescheduled or transferred from 8/30/23 through 9/22/23 listed 19 (nineteen) cases.

Review of the "Daily Log" found an additional 55 (fifty-five) reports of contaminated trays. In particular, on 9/14/23 gauze was reported in the "casket" (a rigid sterilization container); on 9/15/23 bone was reported in tray, (2) 4 x 4 with blood in tray. Other reports included hair, holes in wrapping, oil, lack of filters, etc.

The survey team was provided evidence of documented communication from staff to senior members of the quality program detailing increasing concerns related to inadequately sterilized surgical instruments first in mid June.

Quality meeting minutes were reviewed for the last 12 months, there was no documentation of and/or discussion of problems related to inadequate sterilization/contaminated surgical instruments.

The survey team was told during interviews conducted with SM #24, #28 and #30 that they were instructed not to file event reports in safewatch but to call the OR desk to log problems with trays. SM #40 was told they were reporting too much.

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."


Facility's response to reported issues

In an interview on 9/20/23 at 3:00 p.m., when asked if they are aware of any changes being implemented, SM #30 replied they have been asked to tag instruments of concern.

On 9/20/23 at 1:45 p.m. they survey team made observations in the Central Sterile Processing (SPD-Sterile Processing Department) where surgical instruments are decontaminated and sterilized. The surveyors were accompanied by SM #7, SM #18, SM #54, SM #31, SM #21 and SM #16. During the observations the surveyor asked SM # 18 if, in light of the increase in safewatch reports of contamination and the findings of hair, bone,blood, bioburden etc., if there has been increased observations, increased audits, inservice and/or training. SM #18 stated they had not instituted any changes but thought infection control personnel came by "last week".

On 9/20/23 at 4:19 p.m., during an interview with Staff Member (SM) #29, the surveyor asked what the quality response was to the issue of bioburden, hair, bone, blood, trash etc. found in surgical trays. SM #29 stated there had been some audits done. SM #29 was asked to provide the survey team with any evidence the issue of contamination had been addressed other than looking at a "water" problem. Specifically the surveyor asked for evidence of any inservice(s), audits, observations, retraining, meeting minutes, etc. The survey team was not provided with any evidence prior to exit on 9/26/23.

On 9/21/23, after the determination of Immediate Jeopardy was presented to facility leadership (Accreditation, Quality, CEO/President, Chair of Surgery, Vice President of Surgery and COO Senior Vice President), the survey team requested to be provided with any additional information that address how the facility was handling the contamination issue, other than looking at water which had been provided. No additional evidence was provided to the survey team prior to exit on 9/26/23.

SM #39 stated in an interview on 9/21/23 at 9:25 a.m. that staff have now been instructed to remove any stained or discolored instruments, audits are in place to look at trays before they go to the sterilizer. SM #39 was asked what was put into place regarding the observations of blood, trash and bone fragments found on the trays. SM #39 replied the trays are being audited by SPD staff and the OR staff are the final check to make sure no contaminated or questionably contaminated instruments get to the patient. The survey team was not provided with evidence of audits. Per their interview documented above, SM #39 was aware of the problem since the end of July-first of August, but was only asked to become involved two weeks ago (around September 1,2023.)

The survey team asked to be provided with the facility's Quality Plan or information pertaining to the organizational structure of the quality program on 9/21/23 and 9/22/23. Over the course of the survey, the survey team asked Staff Members #2, #3, #7, #18, #29 and #30 for any additional documentation of the facility's response to the issue, in particular the response to "bioburden" found in trays. No documentation was provided prior to exit.

Evidence presented above demonstrates:
A, The facility's knowledge of the quality issue;
B, The failure to provide evidence of an analysis and investigation of the adverse events (inadequate sterilization and/or contamination of surgical instruments) was conducted;
C, The failure to address all aspects of the adverse event by focusing only on "water issues"; and
D, The failure to address the issue in a timely manner, directly affected the quality of care provided to patients (procedures delayed, canceled, moved or patient transferred) and increased the risk of adverse outcomes to the patients.

Facility staff was given the opportunity to present documents and/or additional evidence on 9/26/23 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. Interviews and observations conducted on 9/20/23 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 9/20/23 beginning with interviews at 9:45 a.m. and observations at 1:45 p.m. in the Sterile Processing Department/Central Sterile Services (SPD/CSS), the survey team observed three (3) of four (4) surgical instrument trays processed on 9/20/23, which were identified as sterile and ready for use. The trays were inspected and found to be contaminated with unknown brownish red substance, spots, staining and a candy wrapper was found inside a sterile tray. 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 (Centers for Medicare and Medicaid Services), the survey team notified the facility staff on 9/20/23 at 7:05 p.m. of the finding of Immediate Jeopardy (IJ) for the Condition of Participation 482.42 Infection Control. The serious concerns regarding observations of contaminated surgical instrument trays presenting potential for serious harm due to possible exposure to infection, delay, and/or prolongation of surgical interventions was discussed with the facility leadership. An immediate plan of removal was requested.

On 9/25/23 at 3:30 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 surgical trays, at the point of assembly and prior to placement in the sterilizer, will be inspected by the designated staff and if in compliance with standards, validation of tray will be documented. Directors of Operating Rooms (OR) and Sterile Processing Department (SPD), as well as senior leadership will be auditing tray validation documentation daily and send weekly reports to Chief Operating Officer, Chief Nursing Officer and Chief of Infection Prevention and Control. Infection Prevention & Control unit will perform at least five unannounced inspections of SPD per week. 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 9/21/23, OR and SPD staff was not permitted to start their shift until they were educated on the new process, completed assigned education and signed "Tray Validation Attestation".

The surveyor, on 9/26/23 at 10:40 a.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 the facility remained with condition level noncompliance.

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 properly decontaminating and sterilizing surgical instruments and monitoring the process.

Observations of (4) randomly selected sterile surgical trays revealed three (3) of four (4) surgical instrument trays processed on 9/20/23, that were identified as sterile and ready for use were visibly contaminated. This observation resulted in the finding of Immediate Jeopardy.

The findings included:

On 9/20/23 at 1:15 p.m. SM #24 was interviewed and stated, " This problem has been going on for months; not just in (one OR) but in all of them. We have raised concerns multiple times and at one point we went through forty-three (43) trays to get an intact field...all of this has been documented in the facility 'safewatch' system...surgeries were having to be canceled and patients transferred...there were also delays for procedures due to not being able to find clean instruments..."

On 9/20/23 at 11:40 a.m., SM #23 (Senior Vice President and Chair of Surgery) stated, in an interview: "We were aware there were concerns for two (2) months....we have had issues with water filters being discolored and it seems as if we have had some instruments in the cardiac OR (operating room) where we do have some unique surgical instruments...there have been some discoloration and spots; some staining and rust on instruments but the wrap has been intact and the indicators were checked... The circulators and nurses are checking the trays and the majority are spots or corrosions on hinges but it is treated as a contamination...we are looking into why we are getting spots...we are looking at the types of instruments and are engaging specialists to assist...we did have one tray with some suture material and one with an alcohol pad and a few with specks of blood...all the cardiac instruments are being processed off-site..." In addition, SM #23 stated that Infectious Disease/Infection Control was looking into that and the water concerns as well.

At 1:45 p.m.. on 9/20/23 the surveyors made observations in the Central Sterile Processing (SPD- Sterile Processing Department), where the surgical instruments are decontaminated and sterilized. The surveyors were accompanied by SM #7, SM #18 (Dir of Peri-Op Services), SM #54 (Scribe), SM #31 (OR Unit Director) as well as SM #21 SPD, and #16 (SPD). The surveyors requested four random surgical instrument trays that had been processed that day (9/20/23). The trays inspected were two (2) General Major, one (1) Neuro and one (1) EP (Electrophysiology). Of the four (4) trays, three (3) contained visible contamination of reddish brown discoloration that was easily removed with a gloved finger, spots and staining of unknown material and one tray contained a yellow piece what was identified as a candy wrapper inside the sterilized tray. The facility staff present also observed the contamination including the candy wrapper and took pictures/documented the concerns. During the observations the surveyor asked SM # 18 if, in light of the increase in safewatch reports of contamination and the findings of hair, bone,blood, bioburden etc., if there has been increased observations, increased audits, inservice and/or training. SM #18 stated they had not instituted any changes but thought infection control personnel came by "last week".

On 9/20/23 at 4:19 p.m., during an interview with Staff Member (SM) #29, the surveyor asked what the quality response was to the issue of bioburden, hair, bone, blood, trash etc. found in surgical trays. SM #29 stated there had been some audits done. SM #29 was asked to provide the survey team with any evidence the issue of contamination had been addressed other than looking at a "water" problem. Specifically the surveyor asked for evidence of any inservice(s), audits, observations, retraining, meeting minutes, etc. The survey team was not provided with any evidence prior to exit on 9/26/23.

On 9/21/23 at 9:25 a.m., the surveyor interviewed Staff Member (SM) #39 (Infectious Disease/Infection Control) who stated, "My team became more involved in the past two weeks when (CEO) asked me to take the lead on this... We are having every instrument looked at closely to see and make sure nothing is going on and have instructed staff to remove any stained or discolored instruments. We have audits in place to look at the trays before they go to the sterilizer... We are starting from when the surgery is done, the pre-cleaning procedure...we are seeing the trays look good before the sterilizer but after that there seems to be a problem with spotting and discoloration. We have brought in specialists (name) from Virginia Tech who specializes in water quality and we will be probing the water and steam. In the meantime we are moving some of the sterilizing off-site to (sister facilities)...we are also working with (name) from the CDC (Centers for Disease Control) who is an expert in sterilization and disinfection...this is a very complex problem that cannot be solved in one day..." SM #39 explained the processes the facility was monitoring with regards to the concern that the water quality was affecting the instrumentation causing the spotting and discoloration. The surveyor inquired as to what was being done regarding the observations of blood, trash and bone fragments found on the trays as well. SM #39 stated the trays were being audited by SPD staff and OR staff are the final check to make sure questionable instruments don't get to the patient. SM #39 was asked if they have been looking at all areas; SM #39 answered "We haven't been as focused with other areas." SM #39 agreed there was a "human factor" involved as well. The survey team was not provided with evidence of audits. Per their interview documented above, SM #39 was aware of the problem since the end of July-first of August, but was only asked to become involved two weeks ago (around September 1,2023.)

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..."

During the survey, multiple policies and procedures related to the cleaning and sterilization of surgical instruments and maintaining a sterile field were reviewed by the survey team. Employee files for job competencies, as well as facility audits of instruments were also reviewed. Review of the safewatch document found approximately 145 reports related to contamination of surgical trays have been filed since 3/1/23. Review of the "Daily Log" found an additional 55 (fifty-five) reports of contaminated trays. In particular, on 9/14/23 gauze was reported in the "casket" (a rigid sterilization container); on 9/15/23 bone was reported in tray, (2) 4 x 4 with blood in tray. Other reports included hair, holes in wrapping, oil, lack of filters, etc. Quality meeting minutes were reviewed for the last 12 months, there was no documentation of and/or discussion of problems related to inadequate sterilization/contaminated surgical instruments. The survey team was provided evidence of documented communication from staff to senior members of the quality program detailing increasing concerns related to inadequately sterilized surgical instruments first in mid June.

The survey team asked to be provided with the facility's Quality Plan or information pertaining to the organizational structure of the quality program on 9/21/23 and 9/22/23. Over the course of the survey, the survey team asked Staff Members #2, #3, #7, #18, #29 and #30 for any additional documentation of the facility's response to the issue, in particular the response to "bioburden" found in trays. No documentation was provided prior to exit.

On 9/25/23 at 3:30 p.m. the surveyor received from the facility an acceptable plan of removal. After consultation with the State Agency and CMS and validation of the plan via observations, interviews and documentation review, the facility was notified on 9/26/23 at 10:40 a.m. the Immediate Jeopardy has been removed, however the facility remained at a condition level deficiency.

At the time of exit conference on 9/26/23 at approximately 12:15 p.m. the facility staff present, SM #2, #51, #52 and #54 were notified they facility would have to respond with a plan of correction for deficient practice identified.

Based on observation, clinical record review, staff interview and facility document review, the facility failed to A. ensure the proper cleaning of surgical instruments which interfered with the ability to provide quality of care for surgical services and B. failed to ensure one (1) Operating Room (OR) was kept at the recommended temperature per policy.

A. On 9/20/23 the survey team observed three (3) of four (4) 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.

This resulted in the finding in Immediate Jeopardy on 9/20/23 with notification of the facility leadership at 7:05 p.m.

According to interviews and document reviews the facility had been aware of the concerns since July 13, 2023.

B. Operating Room #6 was found to be out of temperature range consistently for six (6) consecutive months. The temperature range per facility policy and established guidelines was 64 to 73 degrees Fahrenheit. The room temperature was documented as averaging consistently 80 degrees or above.

Please refer to A0951 for further information.

Based on observation, staff interview and facility document review, the facility staff:
A. failed to ensure adherence to following policies regarding the cleaning and disinfection of surgical instruments, particularly the monitoring of the manual and mechanical cleaning of the instruments and when concerns were reported taking immediate action to investigate, mitigate, resolve and prevent; and
B. Failed to follow the policy regarding the temperature of one (1) of twenty-four (24) operating rooms (OR), OR #6 designated as the Trauma OR.

The findings included:

A. The facility policy "Cleaning, Care, Transport of Reusable Instruments/Medical Devices" was reviewed and evidenced, in part: "Decontamination of reusable instrumentation/medical devices 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... 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..."

On 9/20/23 the survey team interviewed Staff Members #22, 24, 30, and 40 between 9:45 a.m. and 12:30 p.m. All staff members stated that issues with surgical trays containing instruments with discoloration, staining, blood, bone fragments, hair and trash has been observed consistently in all ORs for past 4-6 weeks and reported to senior and OR leadership on multiple occasions. The issues with contamination were first identified mid-July and escalated to senior leadership. Staff reported having to start surgical procedures with delay or completely cancel due to instrument issues. The staff further stated that all events related to surgical instrument contamination issues have been documented in the facility's safewatch system (adverse event reporting system). The Staff Member #40 stated that leadership explained to them this was a "water contamination issue and that staff needed re-education on what contamination actually was" because they were reporting too much.

On 9/21/23 at 9:25 a.m., the surveyor interviewed Staff Member (SM) #39 who stated, "I was made aware of the concerns with the instruments at the end of July-first of August...I was given full reign to look into this account two weeks ago...we started to look at the water concerns..."

On 9/20/23 at 11:40 a.m., SM #23 stated, in an interview: "We were aware there were concerns for two (2) months...there have been some discoloration and spots; some staining and rust on instruments but the wrap has been intact and the indicators were checked ... all the cardiac instruments are being processed off-site..."

At 1:45 p.m.. on 9/20/23 the surveyors made observations in the Central Sterile Processing (SPD- Sterile Processing Department), where the surgical instruments are decontaminated and sterilized. The surveyors were accompanied by SM #7, SM #18 (Dir of Peri-Op Services), SM #54 (Scribe), SM #31 (OR Unit Director) as well as SM #21 SPD, and #16 (SPD) that witnessed the observations. The surveyors requested four random surgical instrument trays that had been processed that day (9/20/23). The trays inspected were two (2) General Major, one (1) Neuro and one (1) EP (Electrophysiology). Of the four (4) trays, three contained visible contamination of reddish brown discoloration that was easily removed with a gloved finger, spots and staining of unknown material and one tray contained a yellow piece of what was identified as a candy wrapper inside the sterilized tray.

On 9/25/23 at 1:30 p.m. the surveyor inquired if there had been any education or monitoring of central sterile staff during the period when the concerns were identified. Staff Member #3 (Quality), SM #7 and #18 were not aware of any education or additional audits or monitoring until the facility developed a plan of removal for Immediate Jeopardy and started audits of the surgical trays on 9/21/23.


B. The surveyors requested and received the temperature and humidity logs for the 24 Operating rooms. According to the documentation, the temperature in OR #6, identified as the Trauma OR, ranged from 74.6 to 82.89 degrees Fahrenheit from March through September 19, 2023. The 12 hour maximum temperature ranged over 80 degrees Fahrenheit during that time. The surveyor requested further information and the facility policy regarding OR temperatures on 9/21/23. SM #3 (Quality) stated on 9/22/23 at 9:30 a.m. there was a sign on the OR #6 that in order to prevent hypothermia in trauma patients that the temperature was to be kept higher. The surveyor requested the facility policy that evidenced the rationale and literature for validating and maintaining a higher temperature.

On 9/25/23 at 11:30 a.m. SM #2 (Accreditation) stated there was nothing in the current policy "however, we do have evidence based literature that the higher temperature is appropriate and we are revising our policy. This policy was not in place at the time the survey team requested it but we have revised it."

The policy the surveyors received "Critical Air Pressure Relationships" last updated 03-2021 evidenced, in part: "6. The temperature range for operating rooms are typically between 64 to 73 (degrees Fahrenheit) dependent on AIA/FGI (American Institute of Architects/Facility Guidelines Institute) or as appropriate for the care and treatment of patients...any changes to these ranges shall be reviewed by Infection Prevention, Engineering and Maintenance and Surgery Clinical staff as described above and documented by the facility..."

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

The above noted concerns were discussed with the facility staff present, SM #2 (Accreditation), #2 (Quality), #51 (Chief of Quality), #52 (Interim VP of Quality) and #54 (Administration) at the exit conference on 9/26/23 at approximately 12:15 p.m. and notified they would have to respond with a plan of correction for the Conditions of Participation and standards identified.