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Based on interview and record review, the hospital failed to comply with the Conditions of Participation for Surgical Services as evidenced by:

Failure to follow its policy and procedure (P&P) titled "Universal Protocol" when: (1) medical providers performed a procedure on the wrong side for one patient, and (2) there was no time out documentation for each procedure performed.

The cumulative effect of these deficient practices resulted in the hospital's inability to ensure the provision of quality health care.

Based on interview and record review, the facility failed to implement surgical services policies for one of 30 sampled patients (Patient 16) when two medical providers performed a procedure on the wrong side and there was no time out process documentation for each of the procedures performed.

These failures resulted in Patient 16 sustaining a pneumothorax (commonly known as collapsed lung, a condition where air leaks into the space between the lungs and chest wall) after a chest tube was placed on the wrong side.

Findings:

A review of Patient 16's "History and Physical" (H&P), dated 1/1/25, indicated Patient 16 was transferred to the facility for a higher level of care on 1/1/25 with diagnoses including acute pulmonary embolism (a condition where a blood clot travels to the lungs and blocks one or more pulmonary arteries), acute kidney injury (a sudden decline in kidney function that occurs over a short period), and acute respiratory failure (a condition where the lungs cannot get enough oxygen into the blood).

A review of Patient 16's H&P, dated 2/4/25, the H&P indicated a computed tomography (CT, a medical imaging technique that uses x-rays, a type of radiation called electromagnetic waves, and computer technology to create detailed cross-sectional images of the body) scan on 2/2/25 displayed left intrapulmonary abscesses (a localized collection of pus within the lung tissue), and small pleural effusion (build-up of excess fluid between the layers of tissue that line the lungs and chest cavity).

During a concurrent interview and record review on 3/7/25, at 2:48 p.m., with Nursing Quality Management Coordinator (NQMC) A, NQMC A stated Patient 16 was to have a left chest tube placement on 2/4/25, but ended up having the chest tube inserted in the right side causing pneumothorax. A time out was done to confirm the correct site. NQMC A stated a pigtail (a small, flexible tube with a coiled or looped end used to drain fluid or air from a body cavity or wound) was placed on the right side to correct the pneumothorax.

During an interview on 3/10/25, at 8:54 a.m., with NQMC B, NQMC B stated there was no documentation of the first chest tube placement procedure including time out when the chest tube was inserted on the right side leading to pneumothorax.

During an interview on 3/10/25, at 1 p.m., with the Attending Physician (AP, a fully trained and licensed medical doctor), AP stated a chest tube was to be inserted on the left side of Patient 16's chest because of the concern of empyema (a collection of pus in the area between the lungs and the chest wall). The AP stated Patient 16 was positioned on the bed with the left side down, right side up. The AP stated the Fellow (FP, a type of doctor who has advanced training in a medical subspecialty) tried to insert the chest tube once or twice but was unable to get any fluid. The AP then tried but was only getting air back (air entering the space between the lungs and chest wall through the chest tube). The AP stated he only realized the chest tube was placed on the wrong side after the chest x-ray (uses radiation to create an image of the heart, lungs, and bones) was done.

A review of Patient 16's chest x-ray, dated 2/4/25, indicated the finding of new moderate right pneumothorax.

A review of Patient 16's "Procedure Note," dated 2/4/25, indicated a right insertion of pleural catheter drain (a thin, flexible tube inserted into the space between the lung and chest wall to drain excess fluid) with image guidance under local anesthesia (a type of medication that temporarily blocks pain and other sensations in a specific area of the body) was performed by the AP and the FP. The indication for the procedure was pneumothorax. The Procedure Note further indicated that a time out was performed, and the site of entry was marked. The site of entry was sterilized (process of removing all forms of microorganisms), and local anesthesia was accomplished. Next a small incision (a surgical cut made in skin) was made. A needle was then used to enter the pleural space (a thin, fluid-filled cavity located between the lungs and the chest wall) while aspirating (the process of withdrawing fluid from the body). Then a catheter was advanced into the pleural space, and then connected to a pleurovac chamber (a chest drainage system used to remove fluid and air from the pleural space after surgery or trauma preventing re-entry of air or fluid into the pleural cavity).

A review of Patient 16's "Procedure Note," dated 2/4/25, indicated that a left insertion of pleural catheter drain was performed. The indication for the procedure was pleural effusion. The Procedure Note further indicated that a time out was performed, and the site of entry was marked. The site of entry was sterilized, and local anesthesia was accomplished. At the site of entry, the needle was then advanced but pleural fluid could not be accessed. The procedure was therefore aborted (to stop before being completed).

During an interview on 3/10/25, at 1:31 p.m., with the Nursing Professional Development Specialist (NPDS), the NPDS stated the AORN (Association of perioperative Registered Nursing, a professional organization dedicated to advancing perioperative nursing practice) was utilized and referenced in the facility's policy.

During an interview on 3/10/25, at 1:37 p.m., with the Director of Quality Management Regulatory Affairs (DQMRA), the DQMRA stated the team did not document each time out process for each attempt of chest tube placement.

During an interview on 3/11/25, at 10:12 a.m., with the Director of Informatic Education (DOIE), the DOIE stated the expectation for staff was to document each procedure in the medical record.

During a telephone interview on 3/12/25, at 4:36 p.m., with DQMRA, the DQMRA stated the FP was currently overseas and will not be back until 3/20/25. Unable to be interviewed.

Review of the facility's policy and procedure (P&P), titled "Universal Protocol," dated 7/22, indicated "The purpose of this policy is to provide a process to reduce the risk of wrong patient, wrong procedure, and/or wrong site surgery and procedures ...The following components of the Time Out are required to verify ...correct site ...The LIP (Licensed Independent Practitioner)/APP (Advanced Practice Providers) who initiated the time out must ask the team members if everyone is in agreement before proceeding with the procedure ...For all procedures requiring consent ...the Time Out must be documented in the patient's electronic health record."

Review of the Association of periOperative Registered Nurses (AORN) "Guidelines for Perioperative Practice Time Out," indicated "[5.1] Perform a time out before an operative or other invasive procedure begins. The time out is a tool to prevent wrong site surgeries. The purpose of the time out is for the perioperative team to conduct a final check that the correct patient, correct site, and correct procedure are identified ...[5.2] Use a standardized time-out process as defined by the facility ...[5.2.4] During the time-out process, the team must confirm, at a minimum, the correct patient, site, and procedure to be performed ...[5.2.8] After the time out is performed, document the time out as completed in the patient's medical record in accordance with facility policy ...[5.4] Identify when a subsequent or second time out should be performed or a safety stop initiated. The second time out provided an opportunity for members of the perioperative team to discuss concerns about patient safety and address issues ..."