Southeast Iowa Regional Medical Center

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 50440 Based on medical record review, policy review, and interviews with staff, the Acute Care Hospital (ACH)’s administrative staff failed to ensure hospital staff administered medications in accordance with applicable hospital policies and procedures for 1 of 10 sampled patients (Patient #5) who received inpatient medical care from 2/10/25 to 10/1/25. Failure to appropriately review and reconcile patient medications, per hospital policy and accepted standards of practice, resulted in Patient #5 (P5), a patient with a history of a renal (kidney) transplant, admitted for increased weakness, fatigue, decreased urine output, and kidney failure, receiving multiple incorrect doses of tacrolimus (an immunosuppressive drug), which staff erroneously administered 10 times the appropriate dose (5 mg instead of 0.5 mg) of the medication. The cumulative effects of these systemic failures and deficient practices resulted in the inability of the ACH’s administrative staff to ensure all patients received safe and appropriate nursing services. This failure placed patients at an increased risk of experiencing adverse health outcomes, including serious injury or disability.”

“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: 50440 Based on medical record review, review of hospital policies and procedures, and interviews with staff, the Acute Care Hospital (ACH)’s administrative staff failed to ensure hospital staff safely and appropriately administered medications for 1 of 10 sampled patients (Patient #5) who received inpatient medical care from 2/10/25 to 10/1/25. Findings include: 1. Review of the 09/2024 policy “Medicine Reconciliation” revealed in part: a. Policy: “1. The medication reconciliation process should be completed at each of the following points-of-care: a. Admission (inpatient or observation status). b. Discharge to home or transfer to another facility. c. Emergency Department . . . 2. The medication reconciliation process should be completed within 24 hours of admission and includes the following steps: a. Obtaining and recording the most complete and accurate list possible of all current medications (medication history) for each patient. The clinician with initial contact with the patient is generally responsible for historical medication documentation. For the purpose of reconciliation . . . “medication” includes: i. Prescription medications, ii. Over-the-counter medications. b. Comparing the medication history against admission and discharge orders. c. Resolving any discrepancies between the home medication list and ordered medications.” b. Procedure: “1. The admission, transfer and discharge reconciliation display should contain both the home medication list and current medications. Whenever reconciliation is carried out, both lists should be considered . . . 2. At point of entry, patient home medications should be reviewed, updated and documented by nursing, clinical staff, providers, or pharmacy dependent on the clinical setting during the admission process. a. The medication list should include prescribed medications . . . including drug names, dosages, frequencies and route . . . c. If a medication is taken . . . clinical staff should document the last dose date/time the medication was taken.” c. “3. Sources for obtaining an accurate Home Medication List, when patient/family members are not considered to be a reliable source of information are: a. Patient’s pharmacy. b. Previous hospital records. c. Provider office records. d. . . search through EHR (electronic health records).” d. “4. Once the historical medications have been updated or confirmed . . . the medications are ready for the Provider to reconcile.” e. “5. The Attending Provider should review the historical medication list and reconcile . . . The historical medication converts to an inpatient order . . . The provider should add the required information to create a valid inpatient order . . . It is the provider’s responsibility to determine what dose is to be ordered.” f. “6. Once all medications have been addressed . . . The medication orders now go to the pharmacist for verification and to the nurse/clinical staff for review.” 2. Review of P5’s 2/9/25 medical record revealed the following: a. On 2/9/25 at 2:31 PM, P5, a patient with a history of a previous renal transplant, presented to the emergency department (ED) with complaints of fever, increased fatigue, weakness, and decreased urine output. On 2/10/25, a chest x-ray (CXR) of the patient revealed clinically significant cardiomegaly (an abnormal enlargement of the heart) and evidence of newly developed pericardial effusion (a buildup of excess fluid around the heart); physical examination of the patient revealed significant dyspnea (difficulty breathing or breathlessness) upon ambulation (walking). b. On 2/10/25 at 8:58 AM, Staff G (Registered Nurse (RN)) administered 5 mg of tacrolimus (an immunosuppressive medication used to prevent organ transplant rejection). c. On 2/10/25 at 11:49 PM, Staff Q (RN) administered 5 mg of tacrolimus. d. On 2/11/25 at 8:23 AM, Staff M (Nursing Student) administered 5 mg of tacrolimus. e. On 2/11/25 at 1:56 PM, staff transferred the patient to the Intensive Care Unit (ICU). f. On 2/11/25 at 8:26 PM, Staff P (RN) administered 5 mg of tacrolimus. g. On 2/11/25 at 3:52 PM, Staff S (Nephrologist) ordered blood sample analyses to assess the levels of tacrolimus in the patient’s blood twice on 2/12/25.. h. On 2/12/25 at 8:05 AM, Staff N (RN) administered 5 mg of tacrolimus.i. On 2/12/25 at 8:25 AM, staff collected a blood sample for laboratory analysis of the patient’s tacrolimus level, which revealed a result of 54.3 ng/mL on 2/17/25 at 3:06 AM. j. On 2/12/25 at 11:45 AM, Staff S (Nephrologist) discontinued the order for tacrolimus 5 mg twice daily. k. On 2/12/25 at 7:59 PM, staff collected a second blood sample for laboratory analysis of the patient’s tacrolimus level, which revealed a result of 56.3 ng/mL (reference range of 5.0 to 20.0) on 2/18/25 at 7:07 AM. l. On 2/21/25 at 9:34 AM, Staff N (RN) administered 3 mg of tacrolimus. m. On 2/21/25 at 3:21 PM, Staff K (Internal Medicine Physician) discontinued the order for tacrolimus 3 mg twice daily and documented, “I discussed with nephrologist as well and we decided to resume patient’s tacrolimus 0.5 mg twice daily. This is [the patient’s] home dose.” n. On 2/21/25 at 9:34 AM, Staff T (RN) withheld the patient’s scheduled dose of tacrolimus with the following note: “Not Appropriate at this Time.” o. On 2/21/25 at 5:05 PM, staff transferred the patient to the Medical Telemetry unit. p. On 2/21/25 at 8:21 PM, Staff O (RN) administered 0.5 mg of tacrolimus. q. On 2/22/25 at 8:18 AM, Staff H (RN) administered 0.5 mg of tacrolimus. r. On 2/22/25 at 10:59 AM, Staff U (Nephrologist) documented, “Tacrolimus home dose confirmed as 0.5 mg twice daily. Recommend Tacrolimus 0.5 mg twice daily . . . if discharged home. [The patient] has transplant nephrology follow up with telemedicine next week. Okay to discharge from nephrology point.” s. On 2/22/25 at 12:57 PM, Staff H (RN) documented discharge of the patient home. t. Review of the medical record did not reveal evidence of appropriate review and reconciliation of the patient’s medications upon admission, as required by hospital policy and in accordance with accepted standards of practice. 3. During an interview on 12/9/25 at 11:00 AM, Staff G (RN) reported medication technicians were expected to verify patients’ medication information upon admission. Staff G indicated, in the absence of an available medication technician, an RN would be expected to verify the patient’s medication information. 4. During an interview on 12/9/25 at 5:17 PM, Staff H (RN) reported RNs would not typically review medication information with patients upon admission. Staff H reported pharmacy staff were expected to review this information, but recalled said reviews were sometimes not completed as required by hospital policy. 5. During an interview on 12/9/25 at 2:15 PM, Staff F (Pharmacist) reported P5’s documented medical history identified the patient’s typical dose of tacrolimus as 0.5 mg twice daily (one-tenth of the erroneous dose administered during the hospital encounter). Staff F reported tacrolimus could potentially cause nephrotoxicity (a rapid deterioration in kidney function due to toxic effect of medications or chemicals). 6. During an interview on 12/10/25 at 8:45 AM, Staff K (Internal Medicine Physician) reported they could not confirm whether the tacrolimus 5 mg twice daily had been ordered in error, but indicated they would typically continue a patient’s home dose of the medication during the hospital admission. Staff K reported potential adverse effects of tacrolimus included kidney damage and toxicity, which could warrant consultation with or intervention by the patient’s transplant team. Failure to adhere to hospital policies and procedures and accepted standards of practice related to the safe and appropriate administration of medications, including appropriately reviewing and reconciling all medications upon admission, resulted in Patient #5 (P5) receiving five incorrect doses of an immunosuppressive drug (tacrolimus), which could have resulted in serious harm or injury to the patient.”