The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CLEVELAND CLINIC INDIAN RIVER HOSPITAL 1000 36TH ST VERO BEACH, FL 32960 Sept. 20, 2019
VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on clinical and administrative record review and interview, the facility staff failed to ensure the quality of care provided to patients are not contradicted or without the risk versus benefits of the care being provided being clearly delineated for 1 of 4 sampled patients (Patient # 1).

The findings included:

The clinical record for Patient # 1 disclosed the patient (MDS) dated [DATE] with a 5 day history of progressively worsening left lower extremity pain and swelling. The patient was found to have extensive left lower extremity DVT ( Deep Vein Thrombosis), diagnosed from an Ultrasound of vein lower extremity, left results which noted an "extensive thrombus within the left common femoral, greater saphenous, superficial femoral, popliteal, anterior tibial, posterior tibial and peroneal veins". The Vascular Surgeon on call recommended intravenous anticoagulation. On 03/16/19, the patient was scheduled to have Left Leg Thrombolysis. However review of procedure documentation, the physician performed an IR left lower extremity venogram with mechanical thrombectomy of the left iliac and superficial femoral vein. The physician documented his technique to include "the left popliteal vein was cannulated with micropuncture technique and initially a 6 French sheath was inserted. A 5 French Kumpe catheter and Glidewire were used to pass the deep vein thrombosis in the left superficial femoral and iliac veins. A venogram was performed demonstrating clot. The inferior vena cava was patent. Mechanical thrombectomy of the left iliac and superficial femoral vein was performed utilizing a 14 French sheath an 7 French argon cleaner. The thrombus was removed. Post thrombectomy venography was performed. The patient became hypoxic." The Findings noted, "Prominent thrombus in the left iliac vein and superficial femoral vein removed with mechanical thrombectomy. A stenosis was identified in the left iliac vein consistent with May Thurner syndrome." The Impression also noted, "Complication of Pulmonary emboli with hypoxia and RV Strain which was treated with Pulmonary Embolectomy."

Review of the Manufacturer's DFU (Directions for use) for the Argon Cleaner, noted for the DFU in Peripheral Vasculature indication for use, "The CLEANER 15 Rotational Thrombectomy System is indicated by mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vasculature. Also noted in the CONTRAINDICATIONS was, "The CLEANER 15 Rotational Thrombectomy System is contraindicated in the following:
"In patients without a vascular filter such as an inferior vena cava filter."

The vascular filter such as an Inferior Vena Cava Filter, is a small, metal device designed to trap blood clots and prevent them from traveling to the heart and lungs. Doctors surgically implant the spider-like devices into the largest vein in the body, known as the inferior vena cava.

Patient # 1 did not have a vascular filter inserted prior to the physician utilizing the CLEANER, which was used in her surgical procedure to remove blood clots from her left leg.

Per x-rays/venogram pictures, nursing progress note, the following timeline was derived on 03/16/19:
11:44 AM - The procedure started
11:50 AM - the sheath was inserted.
12:17 PM - 7 French Sheath, picture taken post 1st pass, aspiration of Distal femur area.
12:24 PM - 7 French Sheath, aspiration cleaner pelvic iliac area.
12:26 PM - picture, post 2nd pass
12:30 PM , note documenting multiple passes
12:33 PM - picture, post 7 French cleanser with aspiration (thrombectomy)
12:41 PM - post 7 French Cleaner, 2nd pass proximal iliac pelvic
12:45 PM - Rapid Response called

An interview was conducted on 09/19/19 beginning at 3:03 PM with the Interventional Radiologist # A, who confirmed he was the physician who performed the procedure. The physician was questioned regarding the use of the IVC filter being inserted prior to using the CLEANER, per the manufacturer DFU in peripheral veins. He stated that in practice this is not done and confirmed that Patient # 1 did not have a IVC inserted prior to the Mechanical Thrombectomy. The surveyor also noted that the patient experienced hypoxia shortly after the second pass of the CLEANER and aspiration of the clot. The patient was later noted to have a Pulmonary Emboli. The IVC is used to prevent clots from entering the lungs. It was also stated that the patient was identified to have May Thurner syndrome while in surgery. The patient was noted to have vein compression on the unilateral left common iliac vein and a filter is not put in for this syndrome. A stent is used to open the vessel. With the filter, the blood flow would be slow and interfere with a stent. While performing the surgery for the thrombus, his intent was to remove the clot, continue to use Heparin (blood thinner) and the next step was to insert the stent but the patient developed hypoxia. He stated the clots removed from the lungs were smaller clots and he did not feel the filter would have caught them. He further stated he felt something else was going on with the patient because the clinical picture of the pulmonary emboli for Patient # 1 was vastly different from what the usual PE is exhibited, in reference to the clot size. He stated he removed more smaller peripheral clots. It was later determined the patient has Factor V, which affects the patient's clotting.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on clinical and administrative record review, the facility failed to ensure that the informed consent for the interventional radiological procedure accurately documented the procedure being performed for 1 of 4 sampled patients (Patient # 1).

The findings included:

The clinical record for Patient # 1, who was admitted to the facility on [DATE], revealed a 03/16/19 consent to Operation, Invasive Procedures, Administration of Anesthetics or Procedural Sedation and the Rendering of Other Medical Services. The consent noted that Patient # 1 authorized the physician/Radiologist to perform a Thrombolysis Left leg veins. The consent was signed by the patient and one nurse on 03/16/19 at 11:00 AM. Also documented on the consent the physician noted he had explained the risk, benefits, potential complication, and alternatives of the treatment to the patient and have answered all questions to the patient's satisfaction, and have obtained consent to proceed. This section was signed by the physician/Interventional Radiologist who performed the procedure and another nurse signed as witness.

Review of the facility Imaging report documented the title of the procedure as IR left lower extremity venogram with mechanical thrombectomy of the left iliac and superficial femoral vein.

An interview was conducted on 09/19/19 beginning at 3:03 PM with the Interventional Radiologist #1, the Radiologist who performed the procedure. The physician confirmed he is the physician who signed the consent and performed the procedure. He stated that the named procedure is a clerical error. He usually signs the consents first and leaves it for the nurse to complete the top portion of the consent. He then explains the risk and benefits of both procedures, Thrombolysis and the Thrombectomy with the patient. He then stated the patient opted for the Thrombectomy. However, there is no documented evidence of the patient's consent for the Thrombectomy. He further stated the Thrombolysis is when a catheter is put in, TPA is used and we wait 3 days/72 hours to assess if the procedure worked for removing the clot. If the above procedure does not remove the clot, then the Thrombectomy is performed. The Mechanical Thrombectomy is done in one day, removing the clot mechanically. The consent form apparently was already filled out when he signed it. He affirmed that the Thrombectomy should have been added and have the patient initial the changes but this was not done.

Attempts to contact the nurse who witnessed the consent have been successful.