High Point Regional Health System

“SAFETY POLICY AND PROCEDURES CFR(s): 482.26(b) [§482.26 Condition of Participation: Radiologic Services §. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.] §482.26(b) Standard: Safety for Patients and Personnel The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel. This Standard is not met as evidenced by: 50318 Based on review of hospital policies, procedure guidelines, medical record, and staff interviews, the Radiology Leadership failed to ensure an order for discharge or discharge criteria was established after a radiology procedure in 2 of 3 sampled patients (Patient #1 and #26) who were discharged following a paracentesis procedure. The findings include: Review on 03/12/2025 of hospital policy, “Patient Care - Patient Assessment and Reassessment in the Radiology Department,” effective 05/19/2021 revealed, “... 3 ... The radiologist is the team leader within Imaging Services for patient assessment/reassessment and pain management ...” Request on 03/12/2025 for a protocol or policy related to vital signs monitoring during and after a paracentesis revealed there was no specific protocol for this. Review on 03/13/2025 of hospital Imaging Services document, “Outpatient Paracentesis Process,” effective 01/2020, revealed, “ ... 11. Paracentesis with albumin - if albumin is completed in the Ultrasound room and the patient is stable, PA (Physician’s Assistant)/IR (Interventional Radiologist) discharge patient from Radiology.” Review on 03/13/2025 of guidelines provided by the hospital from the Academy of Medical-Surgical Nurses (AMSN) for Paracentesis, assisting Procedure, revised 11/19/2021, revealed, “ ... Monitor the patient’s vital signs, oxygen saturation level, and respiratory status at an interval determined by the patient’s condition and your facility because no evidence-based research indicates the best practice for frequency of assessing vital signs after a procedure.” Request on 03/14/2025 for discharge criteria related to paracentesis procedures revealed there was no specific, written discharge criteria. 1. Closed medical record review on 03/11/2025 for Patient #1 revealed a 63-year-old patient who presented on 08/02/2022 at 0753 for an ultrasound-guided paracentesis (a procedure that involves inserting a needle into the abdominal cavity to remove excess fluid). An initial set of vital signs were performed at 0830, with a pulse documented as 40, blood pressure 156/81, and oxygen saturation (O2 sat - percentage of oxygen in the blood) as 97%. An informed consent was signed by the patient, a witness, and the Provider at 0830 for paracentesis due to ascites (excess fluid accumulation in the abdominal cavity). A time out was performed at 0835 to verify the correct patient, procedure, and the consent had been signed; puncture to the right lower quadrant of the abdomen was at 0836. Vital signs were performed at 0838, 0844, 0848, 0858, and 0908. An IV (intravenous) was placed at 0837 and 50 grams of Albumin (a protein produced by the liver) was started after the IV insertion. Nurse’s Note at 0910 revealed the drainage was completed with a total of 5.25 liters of clear, yellow fluid removed, and the patient tolerated the procedure well. The IV was removed at 0917. The catheter entry site was assessed at 0918 with a comment, “puncture from paracentesis.” The staff ambulated the patient out of the room to return home at 0918. The Ultrasound Study Result was read by PA #1 who performed the paracentesis and signed by Radiologist #4 at 0937 and revealed the paracentesis was performed, the catheter was removed, and a dressing was applied. Study Result revealed, “The patient tolerated the procedure well without immediate post procedural complication.” A post-procedure image revealed no fluid in the abdomen. Interventional Radiology Procedure Note by PA #1 was signed at 0938 and revealed the risks and benefits were discussed with the patient, including, but not limited to bleeding, infection, and damage to adjacent structures like the bowel and liver. The Procedure Summary revealed a successful ultrasound-guided paracentesis from the right lateral abdomen, which yielded 5.25 liters of clear, yellow fluid. There were no immediate complications, and the patient tolerated it well. Record review revealed there was no discharge order or discharge criteria addressed by the Provider. Interview request on 03/12/2025 revealed PA #1 who performed Patient #1’s paracentesis was unavailable for interview. Interview on 03/12/2025 at 0902 with Nurse #5 who assisted with Patient #1’s paracentesis revealed the Nurse recalled the patient, who was periodically receiving paracentesis. Nurse #5 revealed paracentesis was not performed under sedation. Nurse #5 would monitor the patient’s vital signs every 10 minutes, unless there was a change and would then increase to every 5 minutes. Nurse #5 revealed for post-procedure monitoring, a post-procedure set of vital signs would be taken, the Dermabond was dry, and the patient felt okay/at their baseline. The fluid removed from the patient would also be assessed for any blood and anything outside of the clear, yellow fluid color. Nurse #5 revealed the last set of vital signs at 0908 was indicative that the procedure had ended prior to this. A post-procedure ultrasound image was also taken to show there was no fluid left in the patient’s abdomen; this would be reviewed by the Sonographer, as well as the Nurse and the Provider. Nurse #5 would ask the patient how they were feeling and if they had any concerns after the procedure. Nurse #5 revealed if there was any change or concerns, the Provider would be made aware to assess the patient prior to discharge. Nurse #5 revealed the expectation for discharge was the patient’s vital signs had not changed from their baseline, the albumin, if ordered, was completed, and discharge instructions were given. There was no written protocol or policy for monitoring or discharge criteria for paracentesis procedures. Interview on 03/12/2025 at 0940 with Radiologist #4 revealed the Radiologist recalled the patient. Radiologist #4 revealed paracentesis procedures were not performed under sedation so the patients did not stay for an extended period as this could delay other patients and procedures. For sedation procedures, the patients were typically monitored for one to two hours after, and there was a strict protocol for discharge. Radiologist #4 reiterated paracentesis patients were not staying for hours if there were no changes in their baseline or vital signs. The monitoring and discharge were based off the patient’s vital signs, assessment, and albumin, if ordered. The Radiologist revealed a post-procedure image would be assessed for any fluid left in the patient’s abdomen. The Radiologist was unsure of the monitoring protocol for paracentesis procedures. Interview on 03/12/2025 at 1038 with Sonographer #8 who assisted during the paracentesis recalled the patient, who had received paracentesis monthly. The Nurses were responsible for vital signs, and Sonographer #8 would initially assess the images, check for leaking at the catheter site, and the patient’s general wellbeing prior to discharge. If a patient’s blood pressure was not at their baseline, they would be monitored longer, but typically, patients were not staying for hours for monitoring, especially if their vital signs were at baseline. Sonographer #8 revealed there was not a specific protocol for vital signs for paracentesis procedures. A meeting with the Chief Medical Officer, Radiologist #5, and Director #9 related to Patient #1 and paracentesis procedure monitoring and discharge criteria was held on 03/13/2025 at 1108. There were no specific guidelines for post-paracentesis monitoring as these procedures were considered low-risk procedures without sedation. The patient’s vital signs were monitored as well as their clinical presentation, and the monitoring was specific for each situation/patient. There were no specific discharge criteria for paracentesis procedures, and it was based off each patient’s clinical presentation. Facility Leadership revealed nothing was changed from August 2022 as they felt there were no concerns that would warrant a change. 2. Closed medical record review on 03/12/2025 for Patient #26 revealed a 55-year-old patient who presented on 03/11/2025 at 1101 for an ultrasound-guided paracentesis. An initial set of vital signs was performed at 1129 with a pulse of 77, blood pressure 182/88, respirations 18, and O2 sat 95%. Vital signs were repeated at 1135 with a blood pressure of 183/90 and at 1140 with a blood pressure of 178/90. A time out was performed at 1141 and the procedure started after. Blood pressure readings were performed every 15 minutes starting at 1145, while pulse and O2 sats were performed every 5 minutes. Nurse Note at 1227 revealed drainage was completed with 7.75 liters of clear, yellow fluid removed. The patient tolerated well, and Dermabond and a Band-Aid were applied to the left lower quadrant of the abdomen. The procedure was documented as finished at 1229, and the patient was out of the room at 1234. The Ultrasound Study Result was read by PA #2 who performed the paracentesis and signed by the attending Radiologist at 1359 and revealed the paracentesis was performed, the catheter was removed, and a dressing was applied. The patient tolerated the procedure well without immediate post procedural complication. A post-procedure image revealed no fluid in the abdomen. Record review revealed there was no discharge order or discharge criteria addressed by the Provider. Interview on 03/14/2025 at 1215 with Director #9 revealed the Radiology department used the Society of Interventional Radiology and the American College of Radiology for guidelines, but these were not specific to procedures and did not dictate monitoring after procedures. The basis for their paracentesis monitoring was based off the AMSN guidelines for Paracentesis. The Radiologists determined the protocol for monitoring vital signs (every 5-10 minutes) for paracentesis procedures as there was no specific national guidelines, but it was not written in a policy or protocol. The Nurses were assessing the patients, monitoring their vital signs and clinical presentation, and the Radiologist made the final determination when a patient was ready to be discharged. The discharge criteria was based off the patient’s clinical presentation, including vital signs, but it was not specified in a policy or protocol. NC00211912, NC00189277, NC00189174, NC00192351, NC00199364, NC00200328, NC00201897, NC00204275, NC00207485, NC00216341, NC00218707, NC00227636”