HospitalInspections.org

The Condition of Participation: Nursing Services was out of compliance.

Findings included:

Based on record review and interview, the Hospital failed to ensure medication was reviewed, clarified, and administered appropriately nor in accordance with Hospital policy for 3 Patients (1, #4, and #7) out of a total sample of 16 patients. Patient #1, #4, and #7 was ordered to receive Andexxa, a medication used to reverse anticoagulation, inappropriately and against Hospital policy; Patient #1 experienced bilateral ischemic strokes and expired at the Hospital. The Hospital failed to ensure blood glucose checks were completed as ordered for 1 Patient (#13) out of a total sample of 16 patients. Patient #13 did not have blood sugars assessed as ordered and was discovered to have hyperglycemia (elevated blood sugar caused by insulin resistance or lack of insulin) and required transfer to a higher level of care.

Cross reference:
482.23(b)(6) Standard: Supervision of Contract Staff (A398)
482.23(c) Standard: Preparation and Administration of Drugs (A405)

The Condition of Participation: Pharmaceutical Services was out of compliance.

Findings included:

Based on record review and interview, the Hospital failed to ensure medication orders for Andexxa (a medication used to reverse anticoagulation) were reviewed for appropriateness prior to dispensing for administration to 3 Patients (#1,4,7 ) out of a total sample of 16 Patients. Patients #1, #4, and #7 were ordered to receive Andexxa, a medication used to reverse anticoagulation, inappropriately and against Hospital policy; Patient #1 experienced bilateral ischemic strokes and expired at the Hospital

Cross reference:
482.25(b) Standard: Delivery of Services (A500)

Based on record review and interviews, the Hospital failed to ensure medical staff operated under its approved bylaws for 1 Patients (#13) out of a total sample of 16 patients. Patient #13 required insulin due to Type 1 Diabetes, was not ordered for insulin and experienced hyperglycemia (elevated blood sugar caused by insulin resistance or lack of insulin) and required transfer to a higher level of care.

Findings include:

The Hospital's Medical Staff Bylaws and Rules and Regulations, dated 11/5/24, indicated the following:
-A member of the Medical Staff shall be responsible for the medical care and the treatment of each patient in the Medical Center, for the completeness and accuracy of the medical record, for necessary special instructions, for transmitting reports of patients, and for discharge instruction on diet, medications and activity, and in general, for appropriate follow up.
-The attending physician shall be responsible for the preparation of a complete and legible medical record for each patient. Its contents shall be pertinent and current and meet the current standards of the Hospital and licensing and accrediting agencies.
-When a patient is transferred to another level of care, all orders shall be reviewed, and medication orders shall be reconciled in accordance with the Hospital policy titled Medication List Documentation and Management.
-The attending physician, in accordance with the appropriate guidelines, is primarily responsible for requesting consultation when indicated and for calling in a qualified consultant.
-All medications administered to patients shall be those listed in the latest edition of United States Pharmacopeia-National Formulary, American Hospital Formulary Service, or Micromedex, and on the Hospital medication formulary, as approved by the Pharmacy and Therapeutics Committee, Medical Executive Committee, All requirement of Federal Law and Policy must be met. Drugs brought into the Hospital by patients shall be given only by the approval of the attending physician or designee in accordance with the appropriate guidelines, and in accordance with the guidelines established by the Pharmacy and Therapeutics Committee.

Review of the Hospital Policy titled "Medication List Documentation and Management", dated 11/7/24, indicated the following:
-Purpose: to describe required documentation and management of patient medications in the electronic health record (EHR) for a consistent, accurate, and succinct view of a comprehensive medication lost for the patient.
-It is the shared responsibility of all providers (physicians, advanced practice providers, and pharmacists) to document medications on the medication list and maintain its accuracy. Providers are the only ones who can complete medication reconciliation.
-Medication list management is required for all active patients. For inpatients, a medication list is created at admission, at changes in level of care as appropriate, and prior to discharge.
-Any clinician who documents medications in an EHR note using the EHR medication list as the source assumes responsibility for the accuracy and integrity of the medications from the HER medication list utilized in the note.
-All clinicians will communicate with other clinicians and care providers as appropriate to promote the highest levels of medication list accuracy and patient safety.
-All providers participating in medication list management must reconcile the list regularly or at key points during the patient's care such as initial consultation, complete evaluations, admission and discharge.

Review of policy titled 'Management of the Inpatient on Continuous Subcutaneous Insulin Infusion (CSII) Therapy By External Pump', effective 4/11/24 indicated:
-Contraindications for continuation of CSII include altered state of consciousness.
-Ensure physician has entered order allowing patient to continue use of CSII therapy by insulin pump during hospitalization.
-Disconnect patient from insulin pump (a battery operated computerized device that delivers rapid acting insulin that is stored in a syringe located in the pump), prior to all radiology procedures.
-The insulin pump cannot come in contact with any magnetic field or radiology.
-Patients may remain disconnected for up to one hour. If a patient remains disconnected for more than an hour, obtain a physician's order for alternative insulin delivery.
-Alternate insulin delivery methods should be initiated before insulin pump is discontinued, except in cases of hypoglycemia.

Patient #13 presented to the Hospital's Emergency Department (ED) on 6/12/25 for altered mental status and trouble talking. Patient #13's past medical history includes Type 1 Diabetes and he/she uses a continuous glucose monitor (CGM- a sensor worn under the skin which measures glucose 24 hours a day and sends the information to a device or smartphone) and an insulin pump to manage the disease.

Review of Patient #13's medical record indicated that on 6/12/25 at 7:08 A.M. the Patient was assessed by the ED provider, and it was documented that Patient #13 had a CGM and an insulin pump in place on the lower abdomen. On 6/12/25 at 1:00 P.M., the Critical Response Team (CRT) was activated due to Patient #13 becoming more unresponsive and was responsive to name only. On 6/12/25 at 1:41 P.M., Patient #13 was admitted to the Hospital Medicine Service for further management. On 6/12/25 at 2:37 P.M., Patient #13 had a brain MRI completed in response to his/her altered mental status which indicated scattered microhemorrhages throughout the brain parenchyma (functional tissue of the brain) as well as multiple remote infarcts (an area of dead tissue) in the cerebellar hemisphere and right frontal lobe.

Review of Hospitalist #2's Admission History and Physical Note dated 6/12/25 at 5:55 P.M. indicated that Patient #13 had an altered mental status, was unable to answer questions and that Patient #13 had a history of Type 1 Diabetes Mellitus on an insulin pump. The Note further indicated that Hospitalist #2 reconciled Patient #13's home medication list which included Insulin aspart (a fast acting insulin used to manage blood sugar levels) 100 units/milliliter: use 0-60 units subcutaneous daily; take up to 60 units a day as directed (uses insulin pump), with a plan for fingerstick glucose monitoring and to continue use of the insulin pump.

Further review of Patient #13's medical record indicated a blood glucose level of 407 (a blood glucose level greater than 140 is considered hyperglycemia) on 6/13/25 at 5:38 A.M. A Critical Response Team Nursing event Note dated 6/13/25 at 7:05 A.M. after Patient #13 was found earlier that morning with a decreased level of consciousness, oxygen saturations down to the 80s, tachycardic (elevated heart rate) in the 100s and a blood sugar in the 400s. Patient #13 received 15 units Humalog (a fast acting insulin) on 6/13/25 at 5:48 A.M. Patient #13 was emergently transferred to the Intensive Care Unit (ICU) for airway protection.
Review of Patient #13's orders indicated an order dated 6/12/25 at 5:26 P.M. for Point of Care Testing (POCT) Glucose every 6 hours but failed to indicate Hospitalist #2 ordered any insulin or an insulin regimen to manage Patient #13's Type 1 Diabetes after his/her admission to the Hospital.

During an interview on 7/1/25 at 11:56 A.M., Hospitalist #2 said he remembered Patient #13 and that Patient #13 had been admitted for altered mental status. Hospitalist #2 said he concentrated his care around why Patient #13 had altered mental status and initially Patient #13's blood sugars were normal, so he ordered finger stick blood glucose testing to be done every 6 hours. He said he was made aware the next day that Patient #13 had hyperglycemia. Hospitalist #2 said he missed placing any insulin orders as he was focused on managing care for the Patient's altered mental status. Hospitalist #2 said he never saw an insulin pump on Patient #13 but said that Patient #13 was unable to manage the pump due to his/her altered mental status. Hospitalist #2 said he had a long discussion with Patient #13's partner on 6/12/25 but the insulin pump was never discussed. Hospitalist #2 said there were no insulin orders put in by him for Patient #13 to manage his/her Type 1 Diabetes.

Based on records reviewed and interviews, the Hospital failed to ensure blood glucose checks were completed as ordered for 1 Patient (#13) out of a sample of 16 patients. Patient #13 did not have blood sugars assessed as ordered and experienced hyperglycemia (elevated blood sugar caused by insulin resistance or lack of insulin) and required transfer to a higher level of care.

Findings included:

Review of Hospital Policy titled 'Diabetic Hypoglycemia/ Hyperglycemia', reviewed 12/9/22 indicated:
-Hypo/hyperglycemia is a medical emergency which may occur in stable or unstable patients of all types.
-Hyperglycemia is a blood glucose level greater than 140 milligrams/deciliter (mg/dl)
-Assess for signs and symptoms of hyperglycemia (more common in Type 1 patients: blood glucose greater than 140 mg/dl; acetone, fruity odor of breath, fatigue, thirst, headache, blurred vision.

Patient #13 presented to the Hospital's Emergency Department (ED) on 6/12/25 for altered mental status and trouble talking. Patient #13's past medical history included Type 1 Diabetes and he/she used a continuous glucose monitor (CGM- a sensor worn under the skin which measures glucose 24 hours a day and sends the information to a device or smartphone) and an insulin pump to manage the disease.

Review of Patient #13's medical record indicated that on 6/12/25 at 1:41 P.M., Patient #13 was admitted to the Hospital Medicine Service for further management. Review of Hospitalist #2's Admission History and Physical Note dated 6/12/25 at 5:55 P.M. indicated that Patient #13 had an altered mental status, was unable to answer questions and that Patient #13 had a history of Type 1 Diabetes Mellitus on an insulin pump. On 6/12/25 at 5:26 P.M., Hospitalist #2 ordered Point of Care Testing (POCT) Glucose every 6 hours. Patient #13's blood glucose was documented on 6/12/25 at 8:35 P.M. with a level of 252 and the next blood glucose level was on 6/13/25 at 5:38 A.M. (more than 9 hours after the previous test) with a level of 407.

A Critical Response Team Nursing Event Note dated 6/13/25 at 7:05 A.M. indicated Patient #13 was found earlier that morning with a decreased level of consciousness, oxygen saturations down to the 80s, tachycardic (elevated heart rate) in the 100s and a blood sugar in the 400s. Patient #13 received 15 units Humalog (a fast acting insulin) on 6/13/25 at 5:48 A.M. Patient #13 was emergently transferred to the Intensive Care Unit (ICU) for airway protection.

During an interview on 7/1/25 at 11:56 A.M., Hospitalist #2 said initially Patient #13's blood sugars were normal, so he ordered finger stick blood glucose testing to be done every 6 hours. He said he would expect nursing staff to check blood glucose as ordered. He said he was notified the next day that Patient #13 had hyperglycemia.

Based on record review and interview, the Hospital failed to ensure medication was reviewed, clarified, and administered appropriately nor in accordance with Hospital policy for 3 Patients (#1 and 4) out of a total sample of 16 patients. Patient #1 and #4 were ordered to receive Andexxa, a medication used to reverse anticoagulation, inappropriately and against Hospital policy; Patient #1 experienced bilateral ischemic strokes and expired at the Hospital.

Findings include:

Review of the Hospital titled "Medication Prescribing, Administration, and Dispensing", dated 4/20/23, indicated the following:
-Safely, accurate, and timely administration of medications is a critical process and responsibility when caring for patients. The nurse will be accurate when he/she observes the five rights of drug administration, which are: right medication, right dose, right patient, right route, right time.

-Actions to be taken by a pharmacist or a nurse when medication orders are incomplete, illegible, unclear, or otherwise requires clarification before the order is carried out, include the following: contact the prescriber for clarification, when the prescriber is unavailable, contact the covering responding clinician, when the covering clinician is unavailable, contact the attending physician.
-Medications outside of policy prescribing and administration plans will be discussed with the prescriber, pharmacist, and nurse.
-It is recommended the nurse know the following before administering any medication: average dose.
-Step 2 in medication administration procedure: check patient's medication profile, MAR - Review patients entire medication list. In MAR, scroll to the bottom of the list as PRN medications, single doses, missed doses, and new orders may appear at the bottom of the list. Review parameters, administration criteria, clinical data collection needed, and co-signature requirements.

Review of the Hospital policy titled" Medication Ordering and Transcribing", dated April 2023, indicated the following:
-Review of all orders for medications must include the strength of the medication

Review of the Hospital policy titled "Use of Coagulation Factor Xa (recombinant), Inactivated-zhzo/Andexanet alfa (Andexxa)", dated July 2022, indicated the following:
-Treatment with Andexxa has been associated with serious and life-threatening adverse events, including arterial and venous thromboembolic events, ischemic events, cardiac arrest, and sudden deaths. Therefore, it is crucial to have guidelines in place and to ensure that its use is appropriate, in both indication and dosing regimen.
-Andexanet alfa is available for the reversal of rivaroxaban or apixaban within 18 hours of the last administered dose in patients with life-threatening or uncontrolled major bleeding as defined by: acute (defined as an injury within 12 hours) CNS, epidural, or ocular bleeding and at high risk of expansion, acute CNS or epidural bleeding with expansion on repeat imaging, and acute exsanguinating hemorrhage with known exposure to apixaban.
-Andexxa low dose (Infuse 400mg over 15 minutes followed by 480 mg over 2 hours) indications: apixaban dose 5mg or less, greater than 8 hours (but less than 18 hours) since apixaban administration regardless of the dose.
-Andexxa high dose (Infuse 800mg over 30 minutes followed by 960 mg over 2 hours) indications: apixaban dose greater than 5mg administered less than 8 hours from bleeding event.

1. Patient #1 presented to the Hospital ED on 4/18/25 with a chief complaint of rectal bleeding and dizziness.
Review of Patient #1's medical record indicated the Patient had previously undergone a sigmoidoscopy on 4/15/25 and was having rectal bleeding. Patient #1 was currently prescribed apixaban 5mg (milligram) (an anticoagulation medication) secondary to a diagnosis of atrial fibrillation and reported he/she had taken his/her last dose at 6:00 P.M. on 4/17/25. Patient #1 received one unit of packed red blood cells (pRBC) and was admitted to an inpatient unit at 6:22 P.M. on 4/18/25. After being admitted to an inpatient room, Patient #1 was discovered to have more rectal bleeding at 7:10 P.M. on 4/18/25 and received another unit of pRBCs. Hospitalist #1 documented Patient #1 had last received his/her last dose of apixaban on the afternoon of 4/17/25 and the medication should be put on hold. Hospitalist #1 further documented he discussed the Patient #1 with the Pharmacy, who ordered Andexxa 960mg for the patient.

Review of Patient #1's physician's orders indicated two orders for Andexxa (an 800mg intravenous (IV) dose to be followed by a 960mg IV dose) were entered by Pharmacist #1 for Patient #1 on 4/18/25 at 7:34 P.M. and verbally cosigned by Hospitalist #1 at 7:34 P.M. The orders further indicated Patient #1's last dose of apixaban was 8-18 hours prior, despite his/her last known dose to have been taken at 6:00 P.M. on 4/17/25. The two Andexxa orders also indicated Registered Nurse (RN) #1 acknowledged the orders for Andexxa on 4/18/25 at 8:35 P.M. The two Andexxa orders also indicated the parameters for ordering the low/high dose ranges and indicated the high dose regimen (800mg IV bolus and 960mg IV infusion) was for apixaban doses greater than 5 mg and the low dose regimen (400mg IV bolus and 480mg IV infusion) were for reversal of all doses of apixaban given in the past 8-18 hours.

Patient #1 was transferred to the Intensive Care Unit (ICU) on 4/18/25 at 8:05 P.M. Critical Care Resident #1 documented Patient #1 had received 2 units of pRBCs, was hemodynamically stable, and would receive Andexxa without indicating a medication dose. Patient #1 was administered the 800mg dose on 4/18/25 at 8:25 P.M. (10 minutes prior to RN #1 acknowledging the order) and the 960mg dose at 8:53 P.M. by RN #1. On 4/18/25 at 11:57 P.M., Patient #1 experienced a change in mental status with dysarthric speech and right arm weakness. Critical Care Resident #1 ordered a STAT computed tomography (CT) and Magnetic Resonance Angiogram (MRA) examination for Patient #1. Following Patient #1's MRA and a neurology consult, it was discovered Patient #1 had suffered acute ischemic infarcts (areas of tissue death) to diffuse bilateral areas of his/her brain on 4/19/25. Patient #1 was made comfort measures only (CMO) and expired on 4/19/25.

Further review of Patient #1's medical record failed to indicate RN #1 brought the Andexxa order to the attention of a provider for clarification prior to administration, despite the dose regimen parameters being listed in the orders and indicating the high dose was outside of parameters for Patient #1.

During an interview with the ICU Nurse Director on 6/26/25 at 12:38 P.M., she said Andexxa is typically ordered in the ICU. She said if a patient is ordered for it on an inpatient unit they will be transferred to the ICU to monitor for signs or symptoms of clotting during administration of the medication. She said when an order is entered into a patient's EMR, a nurse can see the medication in the Medication Administration Record (MAR). She said some of the medication information is available by hovering the curser over the medication order. She said the RNs can then expand the medication order which will display dosage, name, any holds, recent actions, current dispensing information, and any order parameters. She said following the Hospital's review of Patient #1's case, it was suggested nursing should be educated on indications for Andexxa use in patients with bleeding. She said once the pharmacy team revises the Hospital's policy on Andexxa, the ICU pharmacist will roll out education to nursing staff in the ICU.
During an interview with the Critical Care Chief on 6/26/25 at 1:42 P.M., he said he reviewed Patient #1's case. He said he did not feel Andexxa was indicated for Patient #1; he said he felt the ordering of Andexxa for Patient #1 was a violation of the Hospital's policy.
RN #1 was not available for interview.

The Hospital failed to ensure Andexxa orders were clarified by nursing staff with a provider prior to an inappropriate administration of the medication to Patient #1.

2. Patient #4 was admitted to the Hospital from an outside hospital on 4/8/25 post pulmonary embolism, seizure activity, and encephalopathy.

Review of Patient #4's medical record indicated was to transition to anticoagulation with apixaban 10mg twice daily x 5 days followed by 5mg twice daily on 4/10/25. A rapid response was called for Patient #4 on 4/9/25 at 12:16 A.M. due to hypotension with a blood pressure of 57/32. Patient #4 received 1 unit of pRBCs, a bolus of normal saline, and started on pressors (medications used to increase blood pressure) to increase his/her blood pressure. Patient #1 was transferred to the ICU on 4/9/25 at 1:11 A.M. It was documented by the critical care resident that Patient #4's hemoglobin was down trending, was a high risk for bleeding, and was on anticoagulation with the last dose of apixaban 10mg administered the night of 4/8/25 at 9:50 P.M. On 4/9/25 at 8:09 A.M. it was identified by CT exam that Patient #4 had an active right retroperitoneal (area of the abdomen behind the abdominal wall.) A critical care resident documented due to life threatening bleed, the plan for Patient #4 would be to reverse anticoagulation. The critical care resident documented speaking with pharmacy and due to the high dose of apixaban, Patient #4 qualified for the high dose of Andexxa.

Patient #4's medical record indicated two orders for Andexxa (800mg IV bolus followed by 960mg IV infusion) entered by the ICU Pharmacist on 4/9/25 at 8:37 A.M. The Andexxa orders further indicated parameters for ordering the low dose regimen (400mg followed by 480mg) for any apixaban dose given 8-18 hours previously. The first 800 mg dose of Andexxa was administered by RN #2 on 4/9/25 at 9:21 P.M.; the orders for Andexxa for Patient #4 were acknowledged by RN #2 on 4/9/25 at 10:54 A.M. Patient #2 underwent embolization (a procedure that involves blocking blood flow to a specific area of the body to stop bleeding) for the retroperitoneal bleed on 4/9/25 at 10:07 A.M.

Further review of Patient #4's medical record failed to indicate RN #2 attempted to clarify the Andexxa dosing for Patient #4 on 4/9/25 despite the order guidelines indicating the Patient was appropriate for the low dose regimen.
During an interview with the Director of Pharmacy on 6/26/25 at 11:45 A.M., he said sometimes there are provider misconception that a greater dose of medication is more effective for the patient, which is not always true in the use of medications such as Andexxa, which are high risk medications.

The ICU Pharmacist and RN #2 were not available for interview.

The Hospital failed to ensure a RN clarified the ordered dose of Andexxa prior to administering the medication to Patient #4.

Based on record review and interview, the Hospital failed to ensure medication orders for Andexxa (a medication used to reverse anticoagulation) were reviewed for appropriateness prior to dispensing for administration to 3 Patients (#1, 4, and 7) out of a total sample of 16 Patients. Patients #1, #4, and #7 were ordered to receive Andexxa, a medication used to reverse anticoagulation, inappropriately and against Hospital policy; Patient #1 experienced bilateral ischemic strokes and expired at the Hospital

Findings include:

Review of the Hospital policy titled "Medication Management", dated March 2025, indicated the following:
-A Hospital pharmacist reviews a prescriber's order prior to dispensing a medication.
-Upon receipt of a prescriber's order for a patient, the pharmacist will: Review the entire medication profile prior to order validation and dispensing the medication with attention to the following: medication allergies, appropriateness of medication, dosage strength, dosage form, frequency and route of administration, medication interactions, therapeutic duplication, compliance with hospital policies and procedures, height, weight, pregnancy, and lactation when appropriate.

Review of the Hospital titled "Medication Prescribing, Administration, and Dispensing", dated 4/20/23, indicated the following:
-Safely, accurate, and timely administration of medications is a critical process and responsibility when caring for patients. The nurse will be accurate when he/she observes the five rights of drug administration, which are: right medication, right dose, right patient, right route, right time.
-Actions to be taken by a pharmacist or a nurse when medication orders are incomplete, illegible, unclear, or otherwise requires clarification before the order is carried out, include the following: contact the prescriber for clarification, when the prescriber is unavailable, contact the covering responding clinician, when the covering clinician is unavailable, contact the attending physician.
-Medications outside of policy prescribing and administration plans will be discussed with the prescriber, pharmacist, and nurse.
-Inpatient medications will be verified by the Pharmacy prior to administration.

Review of the Hospital policy titled "Use of Coagulation Factor Xa (recombinant), Inactivated-zhzo/Andexanet alfa (Andexxa)", dated July 2022, indicated the following:
-Treatment with Andexxa has been associated with serious and life-threatening adverse events, including arterial and venous thromboembolic events, ischemic events, cardiac arrest, and sudden deaths. Therefore, it is crucial to have guidelines in place and to ensure that its use is appropriate, in both indication and dosing regimen.
-Andexanet alfa is available for the reversal of rivaroxaban or apixaban within 18 hours of the last administered dose in patients with life-threatening or uncontrolled major bleeding as defined by: acute (defined as an injury within 12 hours) CNS, epidural, or ocular bleeding and at high risk of expansion, acute CNS or epidural bleeding with expansion on repeat imaging, and acute exsanguinating hemorrhage with known exposure to apixaban.
-Hematology attending consult and approval required: subacute or chronic CNS bleeding (greater than 12 hours from injury or insult), acute symptomatic bleeding in a critical organ area with signs or symptoms of hemodynamic compromise.
-Andexanet alfa is not approved for: bleeding managed with routine supportive measures.
-Indications which require approval by hematology and/or anesthesia require a phone call to the pharmacist on duty to confirm use has been approved.
-Ordering clinician should select the appropriate dose based upon the last dose of the FXa Inhibitor.
-Andexxa low dose (Infuse 400mg over 15 minutes followed by 480 mg over 2 hours) indications: apixaban dose 5mg or less, greater than 8 hours since apixaban administration regardless of the dose.
-Andexxa high dose (Infuse 800mg over 30 minutes followed by 960 mg over 2 hours) indications: apixaban dose greater than 5mg administered less than 8 hours from bleeding event.
-Consult hematology if apixaban dose was last administered greater than 18 hours prior to bleeding or consider alternative.
-Andexxa is not indicated for reversal 18 hours after last dose of factor X inhibitors, Andexxa is not indicated for non-life-threatening bleeds; consider alternatives or consult hematology.

1. Patient #1 presented to the Hospital ED on 4/18/25 with a chief complaint of rectal bleeding and dizziness.

Review of Patient #1's medical record indicated the Patient had previously undergone a sigmoidoscopy on 4/15/25 and was experiencing rectal bleeding. Patient #1 was currently prescribed apixaban 5mg (milligram) (an anticoagulation medication used to prevent clotting) secondary to a diagnosis of atrial fibrillation and reported he/she had taken his/her last dose at 6:00 P.M. on 4/17/25. Patient #1 received one unit of packed red blood cells (pRBC) and was admitted to an inpatient unit at 6:22 P.M. on 4/18/25. After being admitted to an inpatient room, Patient #1 was discovered to have more rectal bleeding at 7:10 P.M. on 4/18/25 and received another unit of pRBCs. Hospitalist #1 documented Patient #1 had last received his/her last dose of apixaban on the afternoon of 4/17/25 and the medication should be put on hold. Hospitalist #1 further documented he discussed the Patient #1 with the Pharmacy, who ordered Andexxa 960mg for the patient.

Review of Patient #1's physician's orders indicated two orders for Andexxa (an 800mg intravenous (IV) dose to be followed by a 960mg IV dose) were entered by Pharmacist #1 for Patient #1 on 4/18/25 at 7:34 P.M. and verbally cosigned by Hospitalist #1 at 7:34 P.M. in the Electronic Medical Record (EMR). The Andexxa orders were verified by the same pharmacist (#1) at 7:35 P.M. who originally entered the orders. The orders further indicated Patient #1's last dose of apixaban was 8-18 hours prior, despite his/her last known dose to have been taken at 6:00 P.M. on 4/17/25. The two Andexxa orders indicated the parameters for the low/high dose ranges within the orders and indicated the high dose regimen (800mg IV bolus and 960mg IV infusion) were for apixaban doses greater than 5 mg and the low dose regimen (400mg IV bolus and 480mg IV infusion) were for doses of apixaban given in the past 8-18 hours.

Patient #1 was transferred to the Intensive Care Unit (ICU) on 4/18/25 at 8:05 P.M. Critical Care Resident #1 documented Patient #1 had received 2 units of pRBCs, was hemodynamically stable, and would receive Andexxa without indicating a medication dose. Patient #1 was administered the 800mg dose on 4/18/25 at 8:25 P.M. and the 960mg dose at 8:53 P.M. by Registered Nurse (RN) #1. On 4/18/25 at 11:57 P.M., Patient #1 experienced a change in mental status with dysarthric speech and right arm weakness. Critical Care Resident #1 ordered a STAT computed tomography (CT) and Magnetic Resonance Angiogram (MRA) examination for Patient #1. Following Patient #1's MRA and a neurology consult, it was discovered Patient #1 had suffered acute ischemic infarcts (areas of tissue death) to diffuse bilateral areas of his/her brain on 4/19/25. Patient #1 was made comfort measures only (CMO) and expired on 4/19/25.

Further review of Patient #1's medical record failed to indicate an attending hematologist was consulted prior to ordering Andexxa, despite the Patient's last dose of apixaban being taken on 4/17/25 at 6:00 P.M. (over 24 hours before the Andexxa was ordered).

Review of Patient #1's Pharmacy intervention documentation regarding the 4/18/25 order for Andexxa 800mg indicated the pharmacist documented the Provider needed help ordering (Andexxa) since not able to locate on the preference list. Physician wants high dose ...recommended considering kcentra (a coagulation factor replacement product indicated for reversal of anticoagulation).

During an interview with Pharmacist #1 on 6/26/25 at 10:53 A.M., he said on 4/18/25 the hospitalist was having difficulty ordering Andexxa in the Hospital's Electronic Medical Record (EMR) and called the pharmacy to enter the orders for Andexxa for Patient #1. He said two other pharmacists said they could not enter the order for the hospitalist. He said he entered the order for the hospitalist, while keeping the hospitalist on the phone. He said he went through the whole order including parameters, instructions, and dosages with the hospitalist. He said the hospitalist told him Patient #1's last dose of Andexxa was taken 8-18 hours prior to trying to order it. He said the hospitalist wanted the high dose ordered for the Patient despite the parameters for ordering the Andexxa and the low dose regimen being indicated.

During an interview with Hospitalist #1 he said he admitted Patient #1 to the inpatient unit. He said Patient #1 had come to the hospital with rectal bleeding. He said Patient #1 was on apixaban and had taken his/her dose the morning of 4/18/25. He said on 4/18/25 he saw Patient #1 in his/her room and was sitting in bed with a puddle of blood under him/her. He said he was unable to order the Andexxa and asked the pharmacist to put the orders in. He said the providers in the Hospital do not have access to enter orders for Andexxa in the EMR. He said he could not recall why Patient #1 was treated with the high dose regimen of Andexxa instead of the low dose regimen. He said Andexxa cannot be administered on the inpatient units, it can only be administered in the ICU.

During an interview with the Director of Pharmacy on 6/26/25 at 11:45 A.M., he said following Patient #1's case it was realized the policy for Andexxa use in the Hospital needed to be revised. He said once the policy is revised, a review of the policy changes will be implemented with the pharmacy staff and nursing staff. He said the current policy does not address the physician ordering capability of Andexxa. He said there are two ordering panels available in the EMR and the hospitalist was attempting to use the pharmacy panel instead of the provider panel. He said Pharmacist #1 recommended the low dose of Andexxa to the hospitalist, but the hospitalist pushed back on the pharmacist for the high dose for Patient #1. He said a hematology consult was never requested for Patient #1 prior to prescribing the Andexxa for him/her, and a hematologist should be consulted when ordering outside of the Hospital's parameters for Andexxa. He said sometimes there are provider misconception that a greater dose of medication is more effective for the patient, which is not always true in the use of medications such as Andexxa, which are high risk medications.

During an interview with the Pharmacy Quality Coordinator she said following incident with Patient #1, the Hospital was updating and revising the Andexxa policy. She said the policy would be finalized on 7/24/25 and once finalized the pharmacy staff could be trained on the policy and procedure changes regarding Andexxa use in the Hospital. She said during review of Patient #1's case, she spoke with Pharmacist #1. She said Pharmacist #1 reported the hospitalist wanted the higher dose regimen of Andexxa for Patient #1. She said ideally a pharmacist would question a dosage of a physician medication order if it was inappropriate. She said the new policy and procedure for Andexxa use will require physicians to consult with their administrator on call if the pharmacist will not verify Andexxa orders placed by them. She said pharmacists should document in the Hospital's intervention system if they do not agree with physician orders. She said from April 2025 through May 2025 there was an increase of Andexxa use in the Hospital, the majority of which were Emergency Department cases; she said there were other patients in this time frame who received inappropriate doses/administrations of Andexxa.

The Hospital failed to ensure a medication order for Andexxa was appropriate for Patient #1 prior to the verification of the order and administration of Andexxa to Patient #1 nor that corrective actions were taken following the event.

2. Patient #4 was admitted to the Hospital from an outside hospital on 4/8/25 status post pulmonary embolism, seizure activity, and encephalopathy.

Review of Patient #4's medical record indicated was to transition to anticoagulation with apixaban 10mg twice daily x 5 days followed by 5mg twice daily on 4/10/25. A rapid response was called for Patient #4 on 4/9/25 at 12:16 A.M. due to hypotension with a blood pressure of 57/32. Patient #4 received 1 unit of pRBCs, a bolus of normal saline, and started on pressors to increase his/her blood pressure. Patient #1 was transferred to the ICU on 4/9/25 at 1:11 A.M. It was documented by the critical care resident that Patient #4's hemoglobin was down trending, was a high risk for bleeding, and was on anticoagulation with the last dose of apixaban 10mg administered the night of 4/8/25 at 9:50 P.M. On 4/9/25 at 8:09 A.M. it was identified on CT examination that Patient #4 had an active right retroperitoneal (area of the abdomen behind the abdominal wall.) A critical care resident documented due to life threatening bleed, the plan for Patient #4 would be to reverse anticoagulation. The critical care resident documented speaking with pharmacy and due to the high dose of apixaban, Patient #4 qualified for the high dose of Andexxa.
Patient #4's medical record indicated two orders for Andexxa (800mg IV bolus followed by 960mg IV infusion) entered by the ICU Pharmacist on 4/9/25 at 8:37 A.M.; the order was also verified by the same pharmacist. The Andexxa orders further indicated Andexxa parameters are to use the low dose regimen (400mg followed by 480mg) for any apixaban dose given 8-18 hours previously. The first 800 mg dose of Andexxa was administered by RN #2 on 4/9/25 at 9:21 P.M.; the orders for Andexxa for Patient #4 were acknowledged by RN #2 on 4/9/25 at 10:54 A.M. Patient #2 underwent embolization (a procedure that involves blocking blood flow to a specific area of the body to stop bleeding) for the retroperitoneal bleed on 4/9/25 at 10:07 A.M.

Further review of Patient #4's medical record failed to indicate hematology was consulted regarding Andexxa for the Patient despite the Patient's bleed being located in a critical organ area with signs or symptoms of hemodynamic compromise.

Review of Patient #1's Pharmacy intervention documentation regarding the 4/9/25 order for Andexxa failed to indicate any documentation from a pharmacist regarding verification of the medication order, despite the lack of hematology consultation and dosing of the medication outside of the Hospital's policy.

During an interview with the Director of Pharmacy on 6/26/25 at 11:45 A.M., he said sometimes there are provider misconception that a greater dose of medication is more effective for the patient, which is not always true in the use of medications such as Andexxa, which are high risk medications.

The ICU Pharmacist was not available for interview.

The Hospital failed to ensure a medication order for Andexxa was appropriate for Patient #4 prior to the verification of the order and administration of Andexxa to Patient #4.

3. Patient #7 presented to the Hospital Emergency Department on 4/18/25 at 9:20 P.M. after experiencing a fall at home.

Review of Patient #7's medical record indicated the Patient had experienced a fall with a head strike a week prior to presenting to the Emergency Department. Patient #7 reported being prescribed apixaban twice daily and his/her last dose was on the night of 4/17/25. Patient #7's home medication list indicated the Patient was ordered for apixaban 5mg by mouth twice daily. A computed tomography (CT) examination was performed for Patient #7 on 4/19/25 at 12:49 A.M. Patient #7's CT examination was interpreted on 4/19/25 at 1:43 A.M., which indicated right acute on chronic holohemispheric subdural hemorrhage (a collection of blood that covers a large portion of one hemisphere of the brain), left acute vs subacute on chronic holohemispheric subdural hemorrhage, and probable small focus of subarachnoid hemorrhage in the right anterior frontal lobe. The Emergency Department Physician documented Patient #7 had a probable small focus subarachnoid hemorrhage in the right anterior frontal lobe; Patient #7 had last taken apixaban greater than 24 hours prior. The Emergency Department Physician documented low dose Andexxa for reversal and arranged for transfer of Patient #7 to another hospital.

Two orders for Andexxa were entered into Patient #7's EMR on 4/19/25 at 3:14 A.M. for an initial 400mg IV dose to be followed by a 480mg IV dose. Both Andexxa orders for Patient #7 were acknowledged by a RN on 4/19/25 at 3:16 A.M.; the initial dose was administered on 4/19/25 at 4:17 A.M. and the second dose was administered at 5:04 A.M.

Review of the Pharmacy Intervention documentation failed to indicate any recommendations were made by the pharmacist regarding Patient #7's 4/19/25 Andexxa orders nor were they contested prior to verification by the pharmacist, despite the Patient's last known dose of Andexxa being administered greater than 24 hours prior. Patient #7's medical record also failed to indicate hematology was consulted prior to ordering the Andexxa for Patient #7 despite being ordered more than 24 hours since the Patient's last apixaban dose.

During an interview with the Pharmacy Quality Coordinator she said ideally a pharmacist would question a dosage of a physician medication order if it was inappropriate. She said pharmacists should document in the Hospital's intervention system if they do not agree with physician orders. She said from April 2025 through May 2025 there was an increase of Andexxa use in the Hospital, the majority of which were Emergency Department cases; she said there were other patients in this time frame who received inappropriate doses/administrations of Andexxa.
The Hospital failed to ensure a medication order for Andexxa was appropriate for Patient #7 prior to the verification of the order and administration of Andexxa to Patient #7.