Health inspection·August 29, 2025

F 757 §72311. Nursing Service - General. (a) Nursing service shall include, but not be limited to, the following: (1) Planning of patient care, which shall include at least the following: (2) Implementing of each patient's care plan according to the methods indicated. Each patient's care shall be based on this plan. §72375. Pharmaceutical Service -Staff. (c) A pharmacist shall review the drug regimen of each patient at least monthly and prepare appropriate reports. The review of the drug regimen of each patient shall include all drugs currently ordered, information concerning the patient's condition relating to drug therapy, medication administration records, and where appropriate, physician's progress notes, nurse's notes, and laboratory test results. The pharmacists shall be responsible for reporting, in writing, irregularities in the dispensing and administration of drugs and other matters relating to the review of the drug regimen to the administrator and director of the nursing service. §483.45 Pharmacy Services Unnecessary Drugs-General. Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used - (3) Without adequate monitoring; or (4) Without adequate indications for its use; or (6) Any combinations of the reasons stated in paragraphs (d)(1) through (5) of this section. The facility failed to ensure 67 out of 67 patients (patients who received Levaquin [a brand name for levofloxacin, a type of antibiotic known as fluoroquinolone used to treat bacterial infections] and Metformin [a medication that helps control the amount of glucose (sugar) in the blood]) (Patients 392, 389, 122, 130, 127, 124, 383, 393, 132, 83, 126, 391, 125, 129, 388, 68, 7, 10, 82, 52, 41, 394, 123, 390, 70, 384, 21, 387, 133, 93, 74, 385, 326, 381, 103, 47, 377, 222, 89, 49, 46, 106, 131, 323, 16, 22, 33, 63, 50, 23, 386, 128, 111, 322, 4, 71, 80, 99, 15, 382, 2, 64, 26, 17, 380, 90, and 65) were free from unnecessary medications when there was inadequate monitoring and systemic failure in management of residents on medications with black box warning (BBW, is the strongest warning the Food and Drug Administration [FDA-it is a federal agency responsible for protecting and promoting public health by regulating and supervising food safety, medications, medical devices, cosmetics, and other products] gives for prescription drugs. It highlights serious or life-threatening risks associated with a medication, signaling to healthcare professionals and patients that they should be aware of potential dangers and use the drug with caution) like Levaquin and Metformin. They are as follows: 1. During a record review of the pharmacy list of patients who had Levaquin from January 2025 to June 2025, it revealed the following: 1a. 54 out of 54 patients (Patients 392, 389, 122, 130, 127, 124, 383, 393, 132, 83, 126, 391, 125, 129, 388, 68, 7, 10, 82, 52, 41, 394, 123, 390, 70, 384, 21, 387, 133, 93, 74, 385, 326, 381, 103, 47, 377, 222, 89, 49, 46, 106, 131, 323, 16, 22, 33, 63, 50, 23, 386, 128, 111, and 322) who received Levaquin, did not have documentation that the BBW was being monitored related to Levaquin use; 1b. 54 out of 54 patients (Patients 392, 389, 122, 130, 127, 124, 383, 393, 132, 83, 126, 391, 125, 129, 388, 68, 7, 10, 82, 52, 41, 394, 123, 390, 70, 384, 21, 387, 133, 93, 74, 385, 326, 381, 103, 47, 377, 222, 89, 49, 46, 106, 131, 323, 16, 22, 33, 63, 50, 23, 386, 128, 111, and 322) who received Levaquin, did not have a care plan developed related to Levaquin's BBW; and 1c. 30 out of 54 patients (Patients 392, 389, 122, 130, 127, 383, 391, 125, 129, 7, 394, 123, 390, 70, 384, 387, 133, 93, 103, 122, 89, 49, 106, 16, 50, 23, 386, 74, 128, and 385) who received Levaquin did not have an appropriate indication or diagnosis (specific and accurate identification of a disease, condition, or injury based on a patient's signs, symptoms, and medical history. 2. During a record review of the facility's list of patients who received Metformin from June 1, 2025, to June 17, 2025, it revealed the following: 2a. 19 out of 19 patients (Patients 4, 71, 80, 99, 15, 47, 222, 382, 83, 2, 64, 26, 17, 7, 10, 82, 380, 90, and 65) who received Metformin did not have documentation that the BBW was being monitored related to Metformin use; and 2b. 19 out of 19 patients (Patients 4, 71, 80, 99, 15, 47, 222, 382, 83, 2, 64, 26, 17, 7, 10, 82, 380, 90, and 65) who received Metformin did not have a care plan developed related to Metformin's BBW. 3. Six out of six patients (Patients 47, 222, 83, 7, 10, and 82) received both Levaquin and Metformin without proper documentation of the medications BBW monitoring and had no care plan developed related to the medications' BBW. 4. The facility's Infection Preventionist (IP) failed to identify and report the facility's irregularities related to frequent prescription and Levaquin use, missed BBW monitoring, inappropriate diagnosis of antibiotic use and no care plans for Levaquin use with BBW; 5. The facility's Consultant Pharmacist (CP) failed to identify and report the facility's irregularities related to frequent prescription and Levaquin use, missed BBW monitoring, inappropriate diagnosis of antibiotic use and no care plans for Levaquin use with BBW during the medication regimen review (MRR) for 67 out of 67 patients. Due to these systemic failures (as stated above) with potential to affect all patients who received or who are still receiving Levaquin and Metformin medications, the facility needed to take immediate action to correct the noncompliance. On 6/18/2025, at 2:56 p.m., an Immediate Jeopardy (IJ, a situation in which the facility's noncompliance with one or more requirements of participation has caused, or is likely to cause, serious injury, harm, impairment, or death to a patient) was identified and declared, in the presence of the facility's Administrator (ADM) and director of nursing (DON) related to the above failures. On 6/23/2025, at 3:56 p.m., the IJ was removed after the ADM submitted an acceptable IJ Removal Plan (IJRP, a plan with interventions to immediately correct the deficient practices), and after the survey team verified and confirmed the corrective actions while onsite. The failures had the potential for patients to suffer a serious adverse effect on: I. Levaquin use including tendinitis (the inflammation or irritation of a tendon, [the fibrous tissue that connects muscles to bones]), tendon rupture (a tear in a tendon, it can result in significant pain, swelling, and inability to move the affected joint), numbness or tingling or pricking sensation "pins and needles" in arms or legs, muscle weakness, muscle pain, joint pain, joint swelling, anxiety, depression, hallucinations, suicidal thoughts, confusion, worsening of myasthenia gravis (a chronic autoimmune disorder in which antibodies destroy the communication between nerves and muscles, resulting in weakness of the skeletal muscles), and abnormal, rapid or strong heartbeat; and II. Metformin use including lactic acidosis (a condition where too much lactic acid [a chemical your body produces when your cells break down carbohydrates for energy] builds up in the body, causing the blood to become too acidic) especially on residents with impaired kidney function, heart failure, or other conditions that can reduce oxygen supply to tissues. 1a. During a concurrent interview with the IP and document review of the facility's Infection Prevention and Control Surveillance Log on 6/12/2025, at 1:23 p.m., the IP confirmed Patient 68 and Patient 89 received Levaquin, and both patients did not have any documentation of BBW monitoring. During an interview with the director of nursing (DON) on 6/13/2025, at 3:10 p.m., DON stated staff used the Medication Administration Record (MAR - a daily documentation record used by a licensed nurse to document medications and treatments given to a resident) to document the medication's black box warning. DON further stated, the nurse would click on the black box beside the medication and the BBW would show up and nurses should document their monitoring in the progress notes. During a concurrent interview with both DON and IP and record review of Patient 68 and Patient 89's e-MAR (electronic MAR) on 6/13/2025 at 3:45 p.m., IP stated whenever nurses would administer the Levaquin to the patient, the BBW would pop up in their system and nurses would document in the patient's progress note if they monitored the BBW. IP further stated nurses from three different shifts (Days, Evening, and Night shift) monitored Patient 68 and Patient 89 related to Levaquin's BBW. During an interview on 6/13/25, at 3:50 p.m. with licensed vocational nurse (LVN) L, she was asked about her understanding of the BBW for the medication Levaquin. She responded that "Levaquin has a rare side effect of tendonitis, it is very painful, can be excruciating pain in a tendon. This must be addressed right away. The doctor should be called right away if the patient experiences this side effect." LVN L also stated in the MAR, the medication will have a black box that nurses will click on prior to administering the medication which will show what precautions to observe for. During an interview with Registered Nurse (RN) I on 6/13/2025, at 3:51 p.m., RN I stated they monitored Levaquin's adverse side effects, but she was not sure about the BBW. During an interview with (LVN J) on 6/13/2025, at 3:57 p.m., LVN J stated the BBW warning should be documented in the progress notes. LVN J confirmed only day shift licensed nurses would be alerted about the Levaquin's BBW because they were the ones who administered the medication. LVN J stated evening and night shift nurses would not be alerted to monitor the BBW because they did not administer the medication. During an interview with (LVN K) on 6/16/2025, at 10:02 a.m., LVN K confirmed the BBW for Levaquin use would show up before the medication administration and nurses should document that the Levaquin's BBW were monitored. LVN K stated evening and night shift nurses would not be able to document because the BBW would not pop up in their electronic documentation. During an interview with Medical Director (MD) on 6/18/2025, at 9:45 a.m., MD confirmed she was aware that Levaquin was being prescribed especially by "old, schooled doctor, and we talked about this before." MD stated when a medication with BBW was ordered, she expected Licensed Nurses (LN) to monitor residents on medication with BBW and to communicate with the doctors and pharmacists. During a review of the facility's policy and procedure titled, "Black Box Warning Medication Policy," date revised 2/5/2025, indicated, "Purpose: To ensure the safe use, monitoring, and documentation of medications that carry an FDA Black Box Warning, which indicates a serious or life-threatening risk associated with the drug. Policy: All medications with a Black Box warning must be reviewed for clinical appropriateness and administered with careful monitoring...4. Documentation: Nursing progress notes must reflect monitoring and resident response." Due to the inconsistencies with staff statements and the above policy and procedure review, the survey team reviewed all residents who received Levaquin from January 2025 to June 17, 2025. For Patient 21: Review of Patient 21's clinical record titled, "Admission Record," indicated she was admitted on 1/18/25, with diagnoses including infection and inflammatory reaction (the body's immune system's response to injury or infection, characterized by redness, swelling, heat, pain, and sometimes loss of function) due to internal left hip prosthesis (artificial hip joint), aortic valve stenosis (narrowing of the valve in the large vessel branching off the heart {aorta} and hypertension (high blood pressure). Review of Patient 21's physician order, dated 2/21/25, indicated Levaquin 750 mg once daily for wound infection until 3/5/25. Review of Patient 21's 2/2025 and 3/2025 MAR, indicated Patient 21 received Levaquin 750 mg daily at 8 p.m. from 2/21/25 until 3/5/25. Review of Patient 21's nursing progress notes dated 2/21 - 3/10/2025, indicated there was no documented monitoring by licensed staff related to the BBW potential serious adverse effects for the use of Levaquin. For Patient 33: Review of Patient 33's clinical record titled, "Admission Record," indicated she was admitted on 10/8/17, with diagnoses including fracture right pubis (a break in the pubic bone, part of the pelvis), osteoarthritis (degenerative joint disease, a condition where the protective cartilage within joints gradually wears down, leading to pain, stiffness, and reduced range of motion) and hypertension (high blood pressure). Review of Patient 33's physician order, dated 5/4/25, indicated Levaquin 500 mg one time only for suspected UTI (Urinary Tract Infection, a bacterial infection that affects any part of the urinary system, including the kidneys, bladder, ureters, and urethra). An additional physician order, dated 5/6/25, indicated Levaquin 500 mg STAT (immediately) for UTI. An additional physician order dated 5/7/25 indicated Levaquin 500 mg one time a day for UTI for 2 days. Review of Patient 33's 5/2025 MAR indicated Patient 33 received Levaquin 500 mg on 5/4/25, at 5:05 p.m., 500 mg at 5:31 p.m. on 5/6/25, and 500 mg at 9:00 a.m. on 5/7/25, and 5/8/25. Review of Patient 33's nursing progress notes dated 5/4 - 5/15/2025, indicated there was no documented monitoring by licensed staff related to the BBW potential serious adverse effects for the use of Levaquin. For Patient 74: Review of Patient 74's clinical record titled, "Admission Record," indicated she was admitted on 4/22/24, with diagnoses including acute kidney failure, rhabdomyolysis (breakdown of muscle tissue that releases damaging protein into the blood) and hypertension (high blood pressure). Review of Patient 74's physician order, dated 1/5/25, indicated Levaquin 500 mg daily for infection for 5 days. An additional physician order, dated 2/10/25, indicated Levaquin 500 mg daily for suspected URI (upper respiratory infection, a common illness caused by viruses or bacteria that infect the nose, throat, and sinuses) for 6 days. An additional physician order, dated 4/26/25, indicated Levaquin 250 mg two tablets STAT for suspected UTI. Review of Patient 74's 1/2025, 2/2025, and 4/2025 MAR indicated Patient 74 received Levaquin 500 mg at 1:00 p.m. from 1/5/25 through 1/9/25, 500 mg at 9:00 a.m. from 2/10/25 through 2/16/25, and 500 mg at 7:53 p.m. on 4/26/25. Review of Patient 74's 1/2025, 2/2025, and 4/2025 nursing progress notes indicated there was no documented monitoring by licensed staff related to the BBW potential serious adverse effects for the use of Levaquin. For Patient 93: Review of Patient 93's clinical record titled, "Admission Record," indicated he was admitted on 11/25/24, with diagnoses including chronic peripheral venous insufficiency (veins have problems sending blood from the legs back to the heart), idiopathic peripheral autonomic neuropathy (damage to the nerves that control automatic body functions) and hypertension (high blood pressure). Review of Patient 93's physician order, dated 2/2/25, indicated Levaquin 500 mg one time only for possible UTI. An additional physician order, dated 2/6/25, indicated Levaquin 500 mg daily for suspected UTI for 6 days. An additional physician order, dated 3/5/25, indicated Levaquin 500 mg one time only for UTI. An additional physician order, dated 3/7/25, indicated Levaquin 500 mg daily for UTI for 7 days. Review of Patient 93's 2/2025 and 3/2025 MAR indicated Patient 93 received Levaquin 500 mg at 7:51 p.m., on 2/2/25, 500 mg at 9:00 a.m. from 2/6/25 through 2/11/25, 500 mg at 5:12 p.m., on 3/5/25, and 500 mg at 9:00 a.m. from 3/8/25 through 3/14/25. Review of Patient 93's 2/2025 and 3/2025 nursing progress notes indicated there was no documented monitoring by licensed staff related to the BBW potential serious adverse effects for the use of Levaquin. For Patient 122: Review of Patient 122's clinical record titled, "Admission Record," indicated he was admitted on 7/7/23, with diagn