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Based on document review, interview and in four (4) of 10 Incident/Occurrences reviewed, it was determined that the facility failed to fully implement its policy for Adverse Event Reporting. Specifically, the facility failed to (a) complete the investigation report of reported events and (b) failed to collect, analyze, and trend the incidents reported within their incident reporting system.

Findings include:
Review of the facility's document "Keepsafe Reported Events," 6/1/2021 to 1/19/2022 noted the following:

1) Incident dated 7/8/21 [Patient #5]- RN documented she found blood in one of the surgical trays, called for other trays. Delay to bring patient back to the operating room. Incident was witnessed by 7 Nurses.
-Was there a deviation from generally accepted performance standard? - Yes
-Did the deviation reach the patient? - Yes
-Indicate if QA is being requested: No response (left blank)
- Resolution and Outcome: None at this time
- Follow-up Action Taken/To be taken: Event Review at a Huddle/Staff Meeting

There was no documented evidence of Follow-up Action Taken.

2) Incident dated 7/26/21 [Patient #3]- RN documented, Physician Assistant informed and showed circulating nurse while surgery was in progress a Metz Scissor had questionable bioburden (unable to determine if it was rust or old blood) in the Coronary Extras tray. Instrument taken out of the tray. The scrub person also discovered a needle driver from the Open-Heart Basic Tray that has somewhat the same state with questionable rust or old blood on it. Instrument was also taken out of the tray. Incident was witnessed by 1-RN, 1-Surgeon, 1-Clinical Nurse Manager
-Was there a deviation from generally accepted performance standards? - Yes
-Did the deviation reach the patient? - Yes
-Indicate if a QA is being requested: No response (left blank)
-Resolution and Outcome: Instrumentation, quality improvement, water testing, instrument purchasing has been done to correct these issues.
-Follow-up Action Taken/To be taken:
Counsel Staff
Event Review at a Huddle/Staff Meeting
Monitor Issue
Review at Quality Forum

There was no documented evidence of Follow-up Action(s) Taken.

3) Incident dated 9/12/21 [Patient #2}- RN documented that fifteen to twenty surgical trays were open between 0700 and 1300 in vain attempt to find trays without any contamination....
-Indicate if a QA is being requested: No response (Left blank)
-Was the outcome being reviewed related to a procedural intervention? No response (Left blank)
-Severity Level (Confirmed): Near Miss- Event did not reach the patient
-Resolution and Outcome- No answer
-Follow-up Action Taken /To be Taken:
Counsel Staff Involved
Monitor Issue

There was no documented evidence of Follow-up Action(s) Taken.

4) Incident dated 10/7/21 [Patient #1] - RN documented "Contaminated Tray... Surgical team aware." Incident was witnessed by 5 Nurses.
-Indicate if a QA is being requested: No response (Left blank)
-Was the outcome being reviewed to a procedural intervention? No response (Left blank)
-Severity Level (Confirmed): Near Miss- Event did not reach the patient
-Resolutions and Outcomes: Will huddle with staff to ensure filters are placed in every tray
-Follow-up Action Taken/To be taken:
Counsel Staff
Event reviewed at huddle /staff meeting
Monitor Issue

There was no documented evidence of Follow-up Action(s) Taken.

Review of the hospital policy titled "Adverse Event Reporting" Number 0105, states:

4. KEEPSAFE Event Distribution
B. Once the event report is entered into the System the report is limited to the authorized event reviewers ...Event reviewers are responsible for monitoring, investigating and trending events. Additionally, events should be escalated to leadership based on severity level, potential risk to patients and trend.

5. Manager Review Process
Upon notification of an event, the originating department manager reviews the original event submission, updates the report as needed, and completes the Follow-up, Resolutions and Outcomes Sections which details any improvement strategies or actions taken or planned and close out the event report as soon as possible, not to exceed 10 business days of the event report. Originating department/unit reviewer may determine if further review, follow-up, or closeout is required by another service/unit and reroute or escalate accordingly.

There is no documentation in the KEEPSAFE event entry to validate implementation of this policy.

During interview on 1/20/22 at approximately 2:00 PM, the findings were discussed with Staff J, Corporate Director of Central Sterilization and Staff K, Director of Central Sterilization. Both staff members responded that the blood/rust was not so but due to equipment that was discolored by heat or chemicals or poor-quality instruments.
During the survey, these findings were also discussed with the Staff N, Manager, Quality and Patient Safety and Staff O, Director of Quality.

Based on the observation, document review and staff interview, the facility failed to ensure that equipment related to Central Sterile Processing Department(CSPD) was maintained to an acceptable level of safety and quality.

Findings Include;

On January 19, 2022, at approximately 1:27pm, during the physical tour of the decontamination room of Central Sterile Processing unit, it was observed that Washer #2 Biomed 426522, had been labeled "Broken Not In Use.". When facility staff was questioned about the washer/sterilizer machine the Central Sterile Technician/Supervisor Staff I stated the machine had not been working since July 2021. However, Staff J Corporate Director/Central Sterile Department Director, stated that the machine had been down for the last two years.

On January 20, 2022, at approximately 11:00am, in the decontamination room, Washer #2 had a sign stating that Washer #2 had a broken water valve and needed hot water coil replacement. The Biomed sticker on Washer #2 revealed the Washer had passed a preventative maintenance in November of 2021.
Review of the maintenance report document titled "Biomed Preventative Maintenance Work Order 11.26.2021" performed by vendor, stated that Washer #2 was in working condition with no issues as of November 26, 2021. Review of the CSPD Staff Meeting Agenda & Minutes for September 22 , 2021 stated that "Instrument Washer #2 will be out of service indefinitely."

On January 20, 2022, at approximately 2:40pm, a staff interview conducted with the Biomed Manager, Staff E, revealed that the procedure for preventative and corrective maintenance of Patient Medical Equipment would be for the technician from the Biomed Engineering Department to check the equipment for issues. Once the issue with equipment is identified, a work order would be documented with corrective action taken with the outside vendor. Once the work was completed and/or the equipment could not be repaired, the equipment would be taken offsite and be arranged for pick up. This was corroborated by the Preventative Maintenance Policy with revision date December 2020, from the Biomedical Engineering Department Policy and Procedure Manual for New York Presbyterian Hospital.

On January 21, 2022, at approximately 2:15pm, interview conducted with the Patient Care Director, Staff K, revealed that the CSPD contacted the vendor directly concerning Washer/Sterilizer #2, without notifying Biomed Department. Staff K continued describing an issue with the water line coming from the Reverse Osmosis Water Tank in which a clog had occurred in 2017. As a result, it was discovered that debris was going Washer #2 causing it to malfunction.

On January 24, 2022, at approximately 10:15am, interview with VP Chief Digital Technology Officer, Staff L, stated that Washer #2 would now be dismantled and taken out of the decontamination room to avoid further confusion regarding Washer/Sterilizer #2.

Based on document review and interview, the facility failed to ensure that staff practiced standard infection control methods to prevent infection. Specifically, staff proceeded with a surgical procedure after removing two (2) contaminated instruments from a surgical tray.

Findings include:

Review of the facility's policy manual number A230 titled "Aseptic Practices: Maintaining a Sterile Field" Revised April 2020 states: "Consider items unsterile if there is any doubt as to the sterility of items."

Review of the facility's Incident/Occurrence (Keepsafe) Reposts noted Incident dated 9/12/21, RN reported that fifteen to twenty surgical trays were open between 0700 and 1300 in vain attempt to find trays without any contamination. Attending Surgeon in the presence of Patient Care Director and Clinical Nurse Manager witness state of trays around 1300 and stated that two instruments (visibly contaminated) should be removed, and the case should proceed with those same trays from which the two instruments were removed. The case proceeded with contaminated trays.

During interview on 1/21/22 at 10:13 AM with Staff F, Chief of Adult Cardiac Surgery, he stated: " ...Soiled instruments were a little bit of an issue for a period of time. Since maybe late summer of August 2021. They (the instruments) were funny looking or discolored. It began when doing the usual inspections when the nurse opened the trays. It was blackish residue, not blood stains. The trays get rejected at the nursing level if the biological indicator looks funny or wrong color. They didn't look like dirty instruments with anything stuck on them."
Surveyor asked Staff F if he did proceed with a procedure after removing two (2) instruments on 9/21/21. Staff F stated: "Yes,...They showed me an instrument with a shade of discoloration. People were getting hypersensitive to the situation of the trays. I asked Staff G, Director of Nursing and Supervisor for the Cardiac Surgery Unit. She looked at it and we did the Bioburden test. It was ok. All other chemical indicators were fine."

At interview on 1/21/22 at 11:20 AM, Staff H, Medical Director of Infection Prevention and Control and Hospital Epidemiologist stated: "What was reported to us is there were instruments that had staining, discoloration. I saw photos. I didn't see the actual instruments. The instruments were tested for Bioburden and came back negative." Surveyor asked Staff H what the standard process was, when finding contaminated instruments in the sterile trays. Staff H responded: "The equipment would be removed. I was more indirectly involved ... The standard process is that the whole tray would be returned." Staff H was asked what she would have done had she been made aware of the occurrence and was involved in the decision-making process. Staff H stated: "If I was asked in that instance before the new process began, I would say that tray had to go back. There was a process in place in peri-op and that process was not followed. At the time, if any instruments were contaminated, the whole tray goes back."

At follow up interview on 1/26/22 at approximately 1:10 PM, Staff H, Medical Director of Infection Prevention and Control and Hospital Epidemiologist when asked if the Infection Prevention and Control Department were involved in the decision to move forward with the procedure on patient # 2 on 9/21/21 stated: "The IPC was not contacted regarding that particular procedure."