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Based on document review, staff interview and in one (1) of 17 medical records reviewed, the facility failed to fully implement it's policy for occurrence reporting and investigation. Specifically: (a) there was no documented report of a patient incident, (b) there was no risk/quality management review of this patient incident, (c) there was no evidence that the incident was thoroughly investigated to identify the problems related to the incident, (d) there was no evidence of the implementation of a comprehensive plan of correction. (Patient #1)

These failures increase the risk of an adverse patient outcome.

Findings include:

Review of the medical record for Patient #1 identified: Documentation by Staff A, Pulmonary Fellow, on 3/8/19 12:41 PM, noted, "Time Out Performed at 10:30 AM. Bronchoscope (an instrument to visualize the airways) was inserted in size 8 trach inner cannula (a tube placed in the windpipe through an artificial opening through the neck). Thick secretions were suctioned, inspection of bronchial tree (the branching system of the windpipe) did not reveal any bronchial lesion or mass or bleeding. While taking the bronchoscope out, it was found that the bronchoscope is stuck in patients' inner cannula (an interlocking artificial airway device) . Multiple attempts to take bronchoscope out were performed. Decision was made to take out whole inner cannula and bag (artificial ventilation performed with a breathing bag) the patient or connect to ventilator. Anesthesia and surgery were called immediately at bedside; however, patient was found to be pulseless. The patient is a DNR (do not resuscitate)."

A review of the facility Incidents Log dated 6/30/18 to 7/1/19, identified that the incident was not documented in the log. Review of the following documents: Incident Detail Report, Quality Management Review and Referral, Quality and Patient Safety Committee Minutes and Quality and Patient Safety Committee of the Board of Trustee, showed no evidence of the occurrence of this incident.

During interview on 7/23/19 at approximately 12:00 noon, Staff O, Sr. Director of Performance Improvement Quality Management, informed surveyor that she was aware of this occurrence, yet it was not classified as an incident because the physicians involved in the case did not report it as an incident. Therefore, this incident was not investigated.

Hospital policy titled "Incident Reporting," last revised 1/16/14, stated "It is the policy of the hospital to require all Hospital staff to identify and report all occurrences that impact or may impact upon patient, employee and visitor safety. It is also the policy that Hospital staff will participate in the review of such occurrences as directed by the Risk Management and Quality Management Departments in support of patient, staff and visitor safety."

The policy also directs "Staff, physician, or other person witnessing or involved in the event: Complete the safety event report on line promptly once an event is discovered."

There was no documented safety event report. There was no documented evidence of a risk/quality management review.

During interview on 7/25/19 at 3:10 PM, Staff A, Pulmonary Fellow and Staff B, Attending Pulmonologist, were asked about the missing report of this incident. They responded that they reported the incident verbally to their upline supervisor.

There was no documented evidence of reporting and that a risk/quality management review was conducted under the direction of Risk Management and Quality Management Departments.

Based on document review and interview, in one (1) of 17 medical records reviewed (Patient #1), the Medical Staff failed to fully implement the facility's policy and procedure when performing a Bronchoscopy Procedure. Specifically, staff failed to: (a) follow the bronchoscopy policy to book the procedure, (b) have the required team members present during procedure, (c) document that each phase of the Time-Out was conducted, (c) have adequate equipment during the procedure.

These failures may have led to an adverse patient outcome.

Findings Include:

Review of the Policy titled: "Bronchoscopy Procedure" last revised January 2011, included:
"Definition: Bronchoscopy is a midline endoscopic procedure to view the anatomy of the tracheal/bronchial airways for presence of any pathology ....There are two types of bronchoscopy procedures-one rigid, mostly done trans orally in the operating room under general anesthesia the other by flexible fiber optic bronchoscopy, otherwise known as FOB. This is mostly done trans nasally for a spontaneously breathing patient. FOB is also performed via endotracheal or tracheostomy tubes.
Procedure:
(a) The procedure is booked through Scheduling Department at least 24 hours in advance or booked as an Add-on case (see attached Mechanism form).
(c) Team members present during this procedure, a Pulmonary Attending, an Anesthesiologist (must be requested), Chief Fellow, Resident, Technician and a RN.
(d) Before the start of the procedure, a Time-Out is performed as per the hospital guidelines."

The documentation on the attached mechanism form, titled "Bronchoscopy Procedure Booking" lists the information that is required for booking and stated: "If bedside, inform this also when booking."

Review of the Medical Record for Patient #1 identified: On 2/28/19 at approximately 9:48 AM, a 65-year-old female arrived at the emergency room by ambulance. Patient's medical history included, Chronic Respiratory Failure, tracheostomy with vent-dependent. The patient was admitted to Medical Intensive Care Unit and on 3/2/19, was down-graded to the Vent Unit for continuation of care.

On 3/7/19, Staff A, Pulmonary Fellow and Staff B, Attending documentation at 7:45 AM, stated "patient hypoxemic (An abnormally low concentration of oxygen in the blood) on 55% oxygen, high clinical suspicion of short thick neck and abdominal adiposity (Fat,obese). Will proceed with bronchoscopy tomorrow to relieve right upper lung atelectasis (Complete or partial collapse of a lung or section of a lung). NPO (nothing by mouth) after midnight."

On 3/8/19, Staff A documented at 7:45 AM, "will proceed with bronchoscopy to reduce RUL (right upper lung) atelectasis ( complete or partial collapse of a lung or section of a lung) and worsening gas exchange with high Fio2 ( Fraction of inspired oxygen)."

Documentation by Staff A on the "Procedure Note," authored 3/8/19 at 12:41, stated "Time Out Performed at 10:30 AM."
Procedure Details/Description: "Time Out called. Bronchoscope was inserted in size 8 trach inner cannula. Thick secretions were suctioned, inspection of bronchial tree did not reveal any bronchial lesion or mass or bleeding. While taking the bronchoscope out, it was found that the bronchoscope is stuck in patients' inner cannula. Multiple attempts to take bronchoscope out were performed. Decision was made to take out whole inner cannula and bag the patient or connect to ventilator. Anesthesia and surgery were called immediately at bedside; however, patient was found to be pulseless. The patient is a DNR (Do Not Resuscitate)."
The documentation also stated, "During the procedure the patient's vital signs were monitored: HR (Heart rate) and SaO2 (Oxygen saturation) were continuously monitored. BP ( blood-pressure) was monitored intermittently with cuff."

There was no documented evidence of this monitoring in the medical record. There are no other documented procedural notes in the medical record.

Staff F, Registered Nurse, Nurse's Note entered on 3/8/2019 at 12:14, "Patient was having bedside bronchoscopy. Time- Out done. During procedure, patient found to be pulseless. ACLS(Advance Cardiac Life Support) protocol done. Patient is DNR. Family informed." There was no other nursing documentation.

There was no documented evidence that the physician followed the policy to book the procedure.

During interview with Staff O, Sr. Director Performance Improvement, on 8/1/19 at approximately 3:00 PM, she stated they could not find any information on the booking.

There was no documented evidence that the required team members were present during the procedure and that an anesthesiologist was requested by the Fellow.

Staff A, pulmonary fellow, on 7/25/19 at 3:10 PM, acknowledged team members present with him were the pulmonary attending, another pulmonary fellow, residents and students.

Staff J, Respiratory Therapist assigned, was interviewed on 7/25/19 at 1:20 PM. He stated that on 3/8/19, he had just finished checking the patient's vent (a mechanical device that helps the patient breathe) setting , and saw the fellow (Staff A) bringing in the bronchoscope and going to "bronch" the patient. According to staff, "I asked him (Staff A) if I should call another respiratory therapist to attend, he said no, so I informed the nurse. It was close to 12:00 noon and I went to another unit, and just a few minutes after, I heard code blue Room 6B. I went there but another therapist was in the room." Staff J stated further that "the nurse and the respiratory therapist should be there in case they need assistance."

Staff F, Registered Nurse, was interviewed on 7/29/19 at 2:30 PM. She acknowledged the doctors did not inform her of the bedside bronchoscopy procedure (a test that allows airways to be visualized), and when the respiratory therapist informed her, she went to the room and assisted with Time-Out, and gave the fellow the medication he asked for, and was told she was not needed in the room.
When asked to define facility time-out protocol, Staff F stated "the family were outside, the fellow said he already had family consent and he had everything that was needed. Besides, there were a lot of doctors in the room. So, after the procedure started, I asked if I was needed, they said no. I left the room. I was with my other patient, I overheard RRT ( Rapid Response Team), then code blue and call for surgery and anesthesiologist. They removed the inner cannula, they started bagging (artificially ventilating with a respirator bag) the patient, unfortunately, the patient expired."


Staff A, Pulmonary Fellow, during interview at 3:10 PM on 7/25/19, acknowledged that the bronchoscope got stuck in the inner cannula, and all attempts to dislodge scope were unsuccessful. He stated "this patient came with a special trach, called XLT-8 (extra-long trach, size 8). Decision was made to take out the whole cannula and patient became pulseless. The other fellow with me in the room began to ventilate patient with Ambu-bag, and I called anesthesia, surgical service, rapid response team."
Staff A acknowledged there was no replacement extra-long trach (XLT-8) after inner and outer cannula were removed.
Staff A acknowledged that he was not aware of when the trach was placed or how long the patient had the trach, and all he knew was that the patient had an XLT (extra-long-trach). It was a special trach because of the shape of the patients' neck.


The facility "Policy and Procedures" on all invasive procedures, last revised 10/27/2016, included the use of a "Safety Checklist - A comprehensive checklist which outlines the elements of items which need to be reviewed and confirmed." An attached document titled "Exhibit 2. Procedural Safety Checklist (Without Anesthesia)," outlines the elements, which includes the verification process, time-out process and "Are all of the supplies, equipment, images and implants you expect present?"
The use of the safety checklist by the Proceduralist and staff, could not be verified.
The "Policy and Procedures" also stated: "The RN, physician, resident and/ or technician will document in patients' medical record; the time that each phase of the Safety Check-List was conducted, the procedural start time, and who was present for the time-out."


There was no documented evidence of an informed consent for the procedure. During interview on 7/25/19 at
3:10 PM, Staff A stated a verbal consent was obtained.
Review of Policy titled "Policy and Procedures," last revised 10/27/2016 stated: "All invasive procedures whether Perioperative Services, the bedside or patient centered labs must be verified to ensure the correct patient, accurate consent form, correct procedure, correct position, and the correct/side/site prior to the start of the procedure ..."
The policy also stated the verification procedure required prior to the start of the invasive procedure, which included, "Availability of all pertinent paperwork will be verified including; a proper informed consent ..."

Based on document review and staff interview, in two (2) of three (3) medical records reviewed, it was determined the facility failed to ensure that patients receive timely nutrition assessment and reassessment, to meet the patients' nutritional needs (Patient #1 and #15).

Findings include:

Review of medical record for Patient # 1 identified: A 65-year-old female was admitted from a nursing home, on 2/28/19, with a tracheostomy (an incision in the windpipe made to allow the passage of air) and a tube for feeding.
The Nutrition screen tool noted a score of 2, which denotes patient is at high nutritional risk. Patient was NPO (nothing by mouth) upon admission. The patient had two pressure ulcers on admission. One pressure ulcer was a Stage IV on the sacrum (Base of the spine) and the other a Stage II on the right back of the thigh.

The Initial Nutrition Assessment done on 3/1/19, failed to address the patient's Stage IV pressure ulcer and the nutritional needs related to this ulcer.

On 3/5/19 a short note by the Dietitian stated that patient diet order of 45 ml/hour of feeding was infusing at 20 ml/hour, which only met 44% of patient's nutritional needs. Dietitian noted she will discuss with the nurse to advance as per gastrointestinal tolerance. There was no documented evidence that this was done.

On 3/8/19, a Nutrition Re-assessment was done, seven (7) days after the initial assessment. Due to the delay in re- assessment, patient's diet remained unchanged to meet her nutritional needs.

Review of the hospital policy titled, "Nutrition Screening, Assessment and Education for In-Patient," stated, "Reassessment - Initial Revisit note to be completed within 4 days from Comprehensive Assessment."


Review of the medical record for Patient # 15 identified: A sixty-year-old patient was admitted on 7/16/19 from a Rehab facility and nutritionally screened as being at low nutritional risk. Skin assessment upon admission noted healed wound to left sacral area with no sign of infection/oozing.

The Initial Nutrition Assessment was done on 7/19/19. Patient's diet was NPO (nothing by mouth) and patient was assessed as underweight. Patient's blood albumin was 2.2 (a normal albumin range is 3.4 to 5.4 g/dl). The patient's nutrition risk level was not re-evaluated.

The Wound Care nurse noted on 7/22/19, patient admitted with Stage II pressure injury to her coccyx (base of spine also known as tailbone). Recommended a Nutrition Consult. There was no evidence that a Nutrition Consult was performed nor was there a documented nutrition re-assessment, at the time of the medical record review on 7/24/19.