The Miriam Hospital

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 32374 Based on policy review, medical record review, and staff interviews, it was determined that the hospital failed to ensure nursing staff performed the required two-nurse verification for intravenous insulin infusion. The hospital failed to ensure compliance with its policy titled “Medication Administration, System Admin 110,” for 1 of 3 patients reviewed for intravenous insulin administration (Patient ID #1). This failure resulted in the incorrect programming of an insulin infusion), causing the patient to receive 100 units of regular insulin over a 30-minute period in error. As a result of the medication administration error, the patient required administration of D50 (a concentrated dextrose solution used for the emergency treatment of severe hypoglycemia) and was transferred to the Medical Intensive Care Unit (MICU) for closer monitoring. Findings are as follows: Review of the hospital policy titled “Medication Administration, System Admin 110,” last revised August 2025, revealed the policy states, in part: “Eight Rights of Medication Administration Practice” Right Patient: Right Medication: Ensure that the medication being given matches what has been prescribed. Right Dose: Ensure that the dosage of the medication matches. Right Route: ...verifying the right route for intravenous infusions also includes tracing from the medication bag to the pump and then to the patient ... Right Time: Right Documentation: Right Reason: Right Response: Appendix 4: Medications Requiring Dual Sign Off (two signatures) Insulin Intravenous infusion, dual sign off required, yes ... Review of Patient ID #1’s clinical record revealed the patient had a history of type 2 diabetes, was currently receiving insulin, and had diagnoses including chronic kidney disease, coronary artery disease, and a history of coronary artery bypass surgery. The patient was admitted to the hospital for right upper quadrant pain and hyperglycemia (high blood sugar). Review of the patient’s Medication Administration Record (MAR) revealed an order dated 8/5/2026 at 3:30 PM for administration of a regular insulin infusion of 100 units in 100 milliliters, to run continuously at 9.7 units per hour. At 3:50 PM, a continuous infusion order was placed for the patient to receive 200 milliliters per hour of 0.9% Normal Saline with 20 milliequivalents of Potassium Chloride. Review of a Significant Event Note dated 8/5/2026 at 7:38 PM, documented by Staff Nurse Employee B, revealed that the patient received 100 units of regular insulin. The patient was administered 2 ampules of D50 and transferred to the Medical Intensive Care Unit (MICU) for closer monitoring. Review of an Internal Medicine Significant Event Note dated 8/5/2026 at 5:43 PM documented that the physician responded to a rapid response event for Patient ID #1after it was reported that they received “an entire insulin bag(approximately 100 units) that was administered over a short period of time”. The infusion pump was programmed to deliver the insulin at 200 units per hour. During an interview conducted with Employee B on 8/24/2026 at 10:31 AM, Employee B confirmed that she was caring for Patient ID #1 at the time of the medication error. Employee B stated that the patient was transferred from the Emergency Department (ED) to the unit at approximately 3:00 PM. Upon arrival to the unit, Patient ID #1 had a “positional IV.” Employee B stated that she was not comfortable initiating the ordered IV insulin infusion through the existing IV access and therefore consulted the vascular access team and requested placement of new IV access. While awaiting placement of the new IV access, Employee B prepared two IV infusion pumps in the patient’s room: one for the insulin infusion and one for the normal saline infusion. Employee B stated that she flushed both infusion lines and connected the tubing to the respective pumps. She then obtained Employee C to perform the required dual verification. In the presence of Employee C, Employee B stated that she “logged in to the computer, scanned the bag, pump, fluids,” then “verified the Medication Administration Record (MAR), verified the pump, and started the infusion.” Employee B stated that she scanned the medication, pump, and intravenous fluids and checked the electronic medication record. However, during the interview, Employee B acknowledged that she scanned the wrong pump for the insulin infusion. Upon clarification, Employee B stated, “I didn’t trace the medication bag to the pump lines.” Employee B explained that she visualized the IV line from the bottom of the pump to the patient but did not look at or physically trace the medication infusion bag to the pump. During an interview conducted with Employee C on 8/24/2026 at 10:56 AM, Employee C stated that she was asked to verify the initiation of the insulin infusion with Employee B. Employee C stated that she verified the order in the computer while Employee B was at the infusion pumps. Employee C stated that she “visualized the IV bags and the pumps but did not trace the IV lines.” Employee C further stated, “I cannot be sure the bag matched the pump since I didn’t touch the pump, I just visualized them.” Employee C acknowledged that she did not physically trace the medication bag to the corresponding pump and IV line. The hospital failed to ensure that the required two-nurse verification for the high-risk medication, intravenous insulin, was performed in accordance with its “Medication Administration, System Admin 110” policy. The policy specifically requires that verification of the right route for intravenous infusions includes tracing the medication from the medication bag to the pump and then to the patient and identifies intravenous infusions as requiring dual sign-off. Neither Employee B nor Employee C physically traced the insulin medication bag through the pump and tubing to the patient during the required dual verification. As a result, the patient received 100 units of regular insulin rather than the ordered rate of 9.7 units per hour.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 43881 Based on record review and staff interviews, it was determined that the hospital failed to ensure that a patient’s implanted chest port (a small medical device placed under the skin, usually in the chest, used to deliver medications, fluids, or take blood samples) was properly de-accessed (safely removing the needle that was inserted into the port) before the patient was discharged to a Skilled Nursing Facility which resulted in the patient’s return to the hospital for 1 of 4 patients reviewed who were discharged from the hospital with implanted ports in place, (Patient ID #1). Findings are as follows: On 5/7/2025, the Rhode Island Department of Health received an anonymous report alleging that Patient ID #1’s chest port was still accessed upon his/her arrival to the Skilled Nursing Facility following discharge from the hospital on 5/1/2025. Record review revealed that the patient was admitted to hospital in April of 2025 for an elective surgical procedure. The record indicated that on the day of his/her admission to the hospital, the patient had an implanted port on the right side of the chest. Further record review revealed that on 5/1/2025 at 7:50 AM, Employee A, Registered Nurse (RN) indicated in the “Lines, Drains, Airways” flowsheet that the patient’s implanted port was due for a needle and a dressing change. However, the “Lines, Drains, Airways” flowsheet failed to reveal evidence that dressing was changed or that the needle was either changed or removed on 5/1/2025. According to the record, the patient was discharged from the hospital and transferred to a Skilled Nursing Facility via ambulance by 12:08 PM on 5/1/2025. Record review revealed that the patient returned to the hospital at 4:44 PM on the same day of his/her discharge and she/he was seen in the emergency department because his/her chest port was never de-accessed prior to discharge to the Skilled Nursing Facility earlier in the day. During a surveyor interview on 5/21/2025 at 9:45 AM with Employee A, RN, she indicated that on the day of the patient’s discharge, she documented in the “Lines, Drains, Airways” flowsheet that the dressing covering the accessed port needed to be changed that day and then sent the Vascular Access Team (team specializing in providing access into a patient’s circulatory system through the insertion of catheters) a “secure chat” informing them of this since she is not certified to change port dressings or port needles. Employee A explained that later in the shift, the ambulance arrived to pick up the patient and she helped the patient settle on the stretcher. Employee A revealed that the Vascular Access Team then reached out to her and asked her if she had de-accessed the patient’s port, but by that time the patient was no longer on the unit. Employee A acknowledged that she did not ensure the patient’s port was de-accessed before she/he left the unit. During a surveyor interview on 5/21/2025 at 2:15 PM with Employee B, Vascular Access Team RN, she confirmed that she was on duty on 5/1/2025 and explained that she is usually consulted to de-access implanted ports upon a patient’s discharge and usually waits for this request from the patient’s nurse. She explained that by the time she rounded on the patient, the patient was gone and so she reached out to the patient’s nurse, Employee A, and asked her if the patient’s port had been de-accessed. When asked if Employee A reached out to her to de-access the chest port before the patient was discharged, she stated that Employee A did not contact her. Based on the information reviewed and the staff interviewed, Employee A failed to ensure the patient’s chest port was de-accessed before the patient left the hospital. Additionally, there was no evidence that Employee A contacted Employee B to de-access Patient ID #1’s chest port prior to discharge.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 43881 Based on record review and staff interview, it has been determined that the hospital failed to ensure the use of restraints was in accordance with the order of a physician for 2 of 7 patients reviewed (Patient ID #’s 1 and 3). Findings are as follows: 1. Record review revealed that Patient ID #1 was admitted to the hospital in April of 2024 after experiencing an infusion reaction. His/her diagnoses include, but are not limited to, cancer and high blood pressure. While in the hospital, the patient’s condition was complicated by hypercapnic respiratory failure (a condition in which too much carbon dioxide is present in the blood) that was likely due to aspiration pneumonia, requiring the application of a Bilevel Positive Airway Pressure (BiPAP) machine, a machine used to help people breathe. According to the record, Patient ID #1 experienced increased agitation and delirium overnight on 4/11/2024 and again on the morning of 4/12/2024, which required the application of restraints. Review of restraint documentation revealed that on 4/11/2024 at 10:21 PM, non-violent restraints were applied to Patient ID #1’s wrists and ankles due to agitation, restlessness, and confusion. The restraints were then discontinued on 4/12/2024 at 7:00 AM. The record revealed that a physician’s order for non-violent restraints was obtained on 4/11/2024 at 10:21 PM, at the time the above-mentioned restraint was initiated for Patient ID #1. However, the order indicated the restraint was for a “physical hold of the patient” rather than the application of a mechanical limb restraint, which was used on the patient’s wrists and ankles. During a surveyor interview on 9/27/2024 at approximately 3:00 PM with the Risk Manager, she revealed that the ordering provider intended to order a mechanical limb restraint for the patient but incorrectly ordered a physical hold restraint instead. 2. Record review revealed that Patient ID #3 was admitted to the hospital in August of 2024 due to significant weight loss, difficulty swallowing, memory difficulties, paranoia, and anxiety. His/her diagnoses include, but are not limited to, type 2 diabetes. According to the record, Patient ID #3 experienced increased agitation overnight on 8/26/2024, which required the application of restraints. Review of restraint documentation revealed that on 8/26/2024 at 7:05 PM, non-violent restraints were applied to Patient ID #3’s left wrist and right ankle due to agitation and restlessness. The restraints were then discontinued on 8/27/2024 at 12:25 AM. The record revealed that a physician’s order for non-violent restraints was obtained on 8/26/2024 at 7:04 PM, at the time the above-mentioned restraint was initiated for Patient ID #3. However, the order indicated that the restraint was for a “physical hold of the patient,” rather than the application of a mechanical limb restraint, which was used on the patient’s left wrist and right ankle. During a surveyor interview on 9/27/2024 at approximately 2:40 PM with the Risk Manager, she acknowledged that the ordering provider incorrectly ordered a physical hold restraint instead of a mechanical limb restraint for the patient.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. This Standard is not met as evidenced by: 43881 Based on record review and staff interview, it has been determined that the hospital failed to ensure restraints were discontinued at the earliest time possible in accordance with federal regulation and hospital policy for 2 of 7 patients reviewed who met restraint discontinuation criteria (Patient ID #’s 2 and 3). Findings are as follows: The hospital’s policy titled, “Lifespan Patient restraint And Seclusion” effective 11/2023 states in part, “ ...Restraint or seclusion must be discontinued at the earliest time ...when the patient no longer exhibits behaviors that interfere with treatment or devices to support medical healing (for non-violent restraint) ...” 1. Record review revealed that Patient ID #2 was admitted to the hospital in September of 2024 due to septic shock. His/her diagnoses included diabetes and chronic obstructive pulmonary disease. While in the hospital, the patient was diagnosed with severe sepsis, she/he became hemodynamically unstable, and became “confused” and “intermittently responsive.” The patient’s code status was changed to comfort measures and she/he later passed away on 9/13/2024 at 1:48 PM. Record review of a nursing progress note dated 9/13/2024 at 10:47 AM revealed that Patient ID #2 was “flailing” his/her arms and “knocked off” his/her Bilevel Positive Airway Pressure (BiPAP) machine, a machine used to help people breathe. As a result, soft restraints were applied to the patient’s wrists and right ankle. Review of restraint documentation revealed that non-violent restraints were applied to Patient ID #2’s wrists and right ankle due to agitation and restlessness on 9/13/2024 at 10:45 AM as this interfered with medical treatment. The patient was then reassessed at 12:00 PM by Employee A, Registered Nurse, who indicated in his assessment that the patient was “sleeping.” The record indicated that Patient ID #2’s restraints were not removed until 1:00 PM, an hour after she/he was “sleeping.” During a surveyor interview with the Risk Manager on 9/27/2024 at approximately 3:00 PM, she was unable to provide evidence that between 12:00 PM and 1:00 PM on 9/13/2024, Patient ID #2 continued to exhibit behaviors that warranted the need for non-violent restraints. 2. Record review revealed that Patient ID #3 was admitted to the hospital in August of 2024 due to significant weight loss, difficulty swallowing, memory difficulties, paranoia, anxiety, and suicide risk. His/her diagnoses include, but are not limited to, type 2 diabetes. Record review of a nursing progress note dated 8/26/2024 at 8:00 PM revealed that Patient ID #3 “became agitated” shortly after being admitted and attempted to get out of bed and leave. The note indicates that staff attempted to redirect the patient without success, and as a result, non-violent restraints were applied to the left wrist and right ankle. Review of restraint documentation revealed that the restraints were applied to Patient ID #3 on 8/26/2024 at 7:05 PM. The patient was then reassessed at 9:00 PM and again at 11:00 PM by Employee B, Registered Nurse, who indicated in both of her assessments that the patient was “calm”, but the restraints were not removed. Further review of restraint documentation revealed that Patient ID #3 was reassessed a third time at 12:25 AM by another nurse on 8/27/2024 who indicated that the patient was “calm” and the restraints were discontinued. During a surveyor interview on 9/27/2024 at 2:50 PM with the Risk Manager and the Clinical Manager of 4 East, the Risk Manager was unable to provide evidence that Patient ID #3 continued to exhibit behaviors that warranted the need for non-violent restraints between 9:00 PM on 8/26/2024 through 12:25 AM on 8/27/2024, upon discontinuation. The Clinical Manager of 4 East indicated that according to hospital policy, the expectation is for restraints to be removed as early as possible. The Clinical Manager revealed she reviews restraint documentation but indicated she was unaware that Patient ID #3 was restrained on 8/26/2024.”