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Based on medical record review, document review, and interview, the facility failed to implement and maintain an effective, ongoing, data-driven Quality Assessment and Performance Improvement (QAPI) program.

Findings:

The facility failed to utilize its Quality Assessment and Performance Improvement Program to: (A) Implement corrective actions, timely educate staff, and/or implement monitoring mechanisms to prevent reoccurrence; and (B) Investigate a reported safety event.
(See Tag A-0286)

Based on medical record (MR) review, document review, and interview, the facility failed to utilize its Quality Assessment and Performance Improvement Program to: (A) Implement corrective actions, timely educate staff, and/or implement monitoring mechanisms to prevent reoccurrence, in six (6) of thirteen (13) reports; and (B) Investigate a reported safety event, in one (1) of thirteen (13) reports.

These failures potentially placed patients at risk of adverse events or outcomes.

Findings:

The facility policy and procedure (P&P) titled, "Quality Assurance Event Report," last revised 11/19/2021, stated the following: " ...Division of Quality and Safety (DQS) and Nursing Quality Management gather information regarding quality or safety events ...staff complete the Safety Event Report for any actual or potential quality or safety event that occurs which may not be consistent with standard operations or care for patients, and results in actual or potential injury, unexpected or negative outcome, or untoward effect. The Safety Event Report helps Division of Quality and Safety (DQS) and Nursing Quality Management identify problems that provide opportunities to improve quality and safety at [facility] through the creation or updating of systems and processes, revision of policies and procedures, correction of identified problems, or remedial action as necessary to provide the highest quality of care to patients."

The facility's Quality of Care and Patient Safety Plan, dated 2023-2024, stated the following: "Purpose: The Quality of Care and Patient Safety Plan defines the framework for the ongoing, center-wide, systematic approach to the design, measurement, evaluation, and improvement of patient care processes and outcomes."

Findings for (A):

(1) Review of Patient #4's medical record identified the following: This patient presented for a planned hemithyroidectomy (a surgical procedure that removes one lobe of the thyroid gland) on 02/06/2024. At 7:25 AM, anesthesia was started, the patient was induced (transitioned from conscious to unconscious) and was intubated (process where a healthcare provider inserts a tube through a person's mouth then down into the trachea) at 7:35 AM with a NIM (neural integrity monitor endotracheal tube- a tube that is used to monitor nerve integrity and muscle activity during head and neck surgical procedures). Staff G (Anesthesiologist) noted resistance when attempting to manually ventilate the patient. Red patches were noted on the patient's chest and the patient was treated for a possible allergic reaction at 7:39 AM. Staff G noted that troubleshooting for the inability to ventilate continued until 7:51 AM, when the patient began to desaturate (drop in blood oxygen level), and the decision to remove the NIM tube and reintubate Patient #4 with an endotracheal tube (ETT - a flexible tube inserted into the airway to help patients breathe) was made. Initially, an attempt to place a size 8.0 endotracheal tube was made. Staff G noted they had difficulty passing the tube, so they switched to a smaller size 6.0 endotracheal tube. The hypoxia (low blood oxygen) and resistance with ventilation resolved after reintubation. At 8:07 AM, a bronchoscopy was performed and identified a foreign body in the trachea, and tracheal tear. The foreign body was removed. At 10:08 AM, Patient #4 underwent a thoracotomy (surgical procedure in which a cut is made in the chest wall to access the lungs or other organs) to repair the tracheal tear.

On 2/9/2024 at 2:04 PM, a bronchoscopy revealed that Patient #4's tracheal tear had healed well. Patient #4 was discharged from the hospital on 2/12/2024.

An investigation meeting was conducted on 2/26/2024. It identified that two (2) medical device alerts, from 2022 and 2024, provided information to the facility about the potential for difficulty ventilating patients with the product. The meeting identified that clinicians were not aware of these medical device alerts. The facility identified that the "supply chain recall/medical alert process should be reviewed and streamlined to assure relevant information reaches our front-line clinicians prior to use of a device with any alert or recall." The investigation concluded that the standard of care had not been met for Patient #4.

During interview of Staff D (Director of Quality Assurance) on 8/22/2024 at 12:50 PM, Staff D stated that a multi-disciplinary group had met and created an interim process to address the findings of the investigation.

During interview of Staff D on 8/22/2024 at 5:00 PM, Staff D stated that a person in each department had been designated to receive medical device alerts and make a clinical decision regarding the alert. The designee would then reply to the supply chain manager to inform them of the plan for the device. Staff D also stated that a staff member was designated to do "spot checks" and had not identified any issues.

Although the facility investigated the event involving Patient #4, the facility could not furnish documented evidence of the new medical device alert process, a written policy or procedure, meeting minutes of the multi-disciplinary group meeting, nor documented evidence of the spot checks or their results.

(2) Review of the facility's Safety Event Report for an event involving Patient #8 on 2/26/2024 identified that the facility was exploring methods for respiratory monitoring of patients during postoperative transport to the recovery area.

Email communication from Staff A (Chief Anesthesia Attending) to the Anesthesia Staff, dated 6/10/2024, documented the process to follow when transporting patients to the recovery area.

Upon request, the facility could not furnish documented evidence that the attending physicians attested to receiving and reading the new transport process, nor of the compliance monitoring for this corrective action plan.

(3) Review of the facility's Safety Event Report for an event involving Patient #9 on 10/4/2023, and the Department of Anesthesia's Quality Assurance Committee Meeting Minutes dated 11/20/2023, identified that a tracheostomy tube (a curved tube inserted into an opening in the neck and windpipe to help a person breathe) was placed in the operating room in this intubated patient on 9/23/2023. Due to recurrent air leaks, the tracheostomy tube was changed with difficulty on 10/04/2023.

The Quality Committee recommended that the "practitioner be notified via letter or conversation [and that] a multidisciplinary quality improvement project is needed to create a hospital wide tracheostomy exchange protocol."

During interview of Staff B (Director of Regulatory Affairs) on 8/22/2024 at 11:10 AM, Staff B stated they emailed the hospital attendings a Tracheostomy Tube Exchange in Ventilated Patients policy and procedure on 2/16/2024.

Email communication from Staff B (Director of Regulatory Affairs) to the facility physician attendings, dated 2/16/2024, contained an attached policy and procedure titled, Tracheostomy Tube Exchange in Ventilated Patients."

Upon request, the facility could not furnish documented evidence that the attending physicians attested to receiving and reading the new policy and procedure, nor that the facility's ninety-six (96) Intensive Care Unit (ICU) nurses and eighty-two (82) Stepdown Unit nurses also received education to this policy. There was no documented evidence of the monitoring of this corrective action plan for compliance. There was no documented evidence of a conversation with or letter to the practitioner.

During interview of Staff C (Chairman of Anesthesia) on 8/22/2024 at 1:15PM, Staff C explained that when the Quality Committee recommends that a practitioner be notified by letter or conversation, this means to "debrief the practitioner.. Unless the practice is not met, then it is informational ...You tell the practitioner what the committee felt ...It's not documented ...You document the debriefing with a letter if the standard of care is not met." Staff C stated that they were not aware of a written process for practitioners to receive a letter, conversation, or counseling.

During interview of Staff B (Director of Regulatory Affairs) on 8/23/2024 at 11:40 AM, Staff B stated there is no written process for practitioners to receive a letter, conversation, or counseling.

(4) Review of the facility's Safety Event Report for an event involving Patient #11 on 10/3/2023, and the Department of Anesthesia's Quality Assurance Committee Meeting Minutes dated 11/20/2023, identified that Patient #11 received a dose of low molecular weight heparin (LMWH - a class of anticoagulant medication used to treat and prevent blood clots), after having an epidural catheter placement. The Meeting Minutes identified that low molecular weight heparin was contraindicated after a catheter placement, and that "the involved providers were counseled."

Upon request, the facility could not furnish documented evidence that the involved providers were counseled.

During interview of Staff C (Chairman of Anesthesia) on 8/22/2024 at 1:15PM, Staff C reviewed the reports and confirmed, "Yes, these practitioners needed to be counseled."

During interview of Staff D (Director of Quality Assurance) on 8/22/2024 at 12:15 PM, Staff D confirmed the findings and confirmed the facility could not provide documented evidence that the providers had been counseled.

(5) Review of the facility's Safety Event Report for an event involving Patient #12 on 9/19/2023, and the Department of Anesthesia's Quality Assurance Committee Meeting Minutes, dated 11/20/2023, identified that the Quality Committee recommended that "the practitioner be notified via letter or conversation."

(6) Review of the facility's Safety Event Report for an event involving Patient #14 on 7/3/2023, and the Department of Anesthesia's Quality Assurance Committee Meeting Minutes, dated 8/21/2023, identified that the Quality Committee recommended "that the practitioner be notified via letter or conversation."

For both events involving Patient #'s 12 and 14, the facility could not furnish any documented evidence of conversations nor letter to the practitioners involved in these cases.

During interview of Staff D (Director of Quality Assurance) on 8/22/2024 at 12:15 PM, Staff D confirmed these findings and confirmed there was no documented evidence of conversations/letters with the practitioners.

Findings for (B):

(7) Review of the facility's Safety Event Report dated 1/3/2024, stated that a supervising anesthesiologist was not available during a critical period. The Quality Committee recommendations stated, "escalate to clinical chief."

Upon request, the facility could not furnish documented evidence of an investigation for this safety event.

During interview of Staff B (Director of Regulatory Affairs) on 8/22/2024 at 11:10 AM, Staff B confirmed this finding.

During interview of Staff C (Chairman of Anesthesia) on 8/22/2024 at 1:15PM, Staff C stated, "I was not aware of this."

During interview of Staff D (Director of Quality Assurance) on 8/22/2024 at 12:15 PM, the above safety event report findings were reviewed with Staff D. Staff D confirmed these findings and stated, "I see we have an issue closing the quality assurance loop at the department level."




48940

Based on observation, document review and interview, in eleven (11) of fifteen (15) Operating Room (OR) observations, the facility did not ensure all generally accepted infection control measures were followed.

These failures potentially placed patients at increased risk of infection.

Findings:

Observations in the facility's 2 Main Operating Room (OR) Suite during a tour between 12:20 PM and 1:30PM on 8/14/2024, identified the following:

(1)In OR #5, within the sterile field, a staff member had approximately three (3) inches of uncovered hair on the nape of their neck (area above the neck) and on the sides of their beard. A second staff member had the sides of their beard uncovered. A surgeon had approximately three (3) inches of uncovered hair above their nape.

(2) In OR #6, within the sterile field, a surgical fellow had the sides of their beard uncovered.

(3) In OR #9, within the sterile field, a surgeon had uncovered sideburns. A scrub nurse had approximately two (2) inches of exposed hair above their forehead. A circulating nurse had approximately two (2) inches of hair above their forehead and on the sides of their face exposed.

Observations in the facility's 6 Main Operating Room (OR) Suite during a tour between 11:00 AM and 1:00PM on 8/15/2024 identified the following:

(4) In OR #2, within the sterile field, two (2) surgeons had approximately three (3) inches of uncovered hair above their nape.

(5) In OR #4, a Certified Registered Nurse Anesthetist (CRNA) had approximately three (3) inches of uncovered hair above their nape and had uncovered sideburns.

(6) In OR #5, within the sterile field, a surgeon and a medical student had approximately three (3) inches of uncovered hair above their napes. The scrub technician had approximately three (3) inches of uncovered hair above their nape and uncovered sideburns.

(7) In OR #9, within the sterile field, a surgeon had approximately three (3) inches of uncovered hair above their nape.

(8) In OR #10, within the sterile field, a surgeon had approximately two (2) inches of uncovered hair above their nape and on the side of her face above their ears. Another staff member had approximately four (4) inches of uncovered hair above their nape.

(9) In OR #11, within the sterile scrub table, a surgeon who was preparing a laboratory specimen had approximately four (4) inches of uncovered hair above their nape. One (1) staff member had approximately four (4) inches of uncovered hair above their nape and the sides of their beard uncovered. A third staff member had the sides of their beard uncovered.

(10) In OR #13, within the sterile field, a surgeon had approximately four (4) inches of uncovered hair above their nape.

(11) In OR #21, within the sterile field, a surgeon had approximately four (4) inches of uncovered hair above their nape and had uncovered sideburns.

The facility's policy and procedure (P&P) titled, "Surgical and Procedural Attire," dated 11/14/2022, stated, "Restricted and Semi-Restricted Areas: Personnel must use head covering that covers the scalp and all exposed hair and facial hair... Facial hair including beards must be covered completely."

During interview of Staff A (Chief of Anesthesiology) on 8/14/2024 at 1:30 PM and 8/15/2024 at 1:00 PM, Staff A confirmed these findings.