Inspector’s narrative
What the inspector wrote
The following reflects the findings of the California Department of Public Health during the investigation of Complaint CA00958145.
Event ID: 7VSH11
F760
(Rev. 173, Issued: 11-22-17, Effective: 11-28-17, Implementation: 11-28-17)
§483.45(f) Medication Errors.
The facility must ensure that its-
(2) Residents are free of any significant medication errors.
California Code of Regulations, Title 22, Section 72313 (a)(2). Nursing Service-Administration of Medications and Treatments.
(a) Medications and treatment shall be administered as follows:
(2) Medications and treatment shall be administered as prescribed.
FINDINGS:
On 5/5/25, an unannounced visit was conducted at the facility to investigate a Complaint regarding Quality of Care/Treatment.
The facility failed to ensure a medication was administered as prescribed by the physician for one of three sampled Residents (Resident 1) when Resident 1 received 12 doses of Tacrolimus (a medication used to suppress [preventing something] the immune system) 5 milligrams (mg, unit of measurement), which was 10 times the ordered dose of 0.5 mg. This failure had the potential to result in Tacrolimus toxicity (the quality of being poisonous or harmful) for Resident 1 and could potentially contribute to Resident 1's hospitalization on 4/19/25.
A review of the manufacturer's Prescribing Information (PI, detailed description of a drug's uses, dosage range, side effects, drug-drug interactions [a change in a drug's effect on the body when the drug is taken together with a second drug], and contraindications that is available to clinicians) for Tacrolimus, issued in December 2018, indicated it is an immunosuppressant (a medication that weakens or reduces the activity of the immune system) indicated for the prophylaxis (measures taken to prevent disease rather than treat an existing one) of organ (a group of tissue that work together to perform a specific function within a living organism) rejection (the act of refusing) in adult and pediatric patients receiving allogenic (transported to its present position from elsewhere) liver, kidney or heart transplant (an operation in which an organ or tissue are moved or transferred to another place).
A review of Resident 1's face sheet (a concise document summarizing a resident's key information) indicated he was admitted on 3/30/25 and had diagnoses including chronic myeloid leukemia (a slowly progressing and uncommon type of blood cell cancer that begins in the bone marrow [the soft tissue found in the bones]), graft versus host disease (a complication that might occur after a transplant, and bone marrow transplant (a procedure where healthy bone marrow stem cells are infused into a person to replace damaged or diseased bone marrow) status, Pneumonia (a type of lung infection), sepsis (a life-threatening complication of an infection).
A review of Resident 1's Skilled Nursing Facility (SNF) orders from the hospital, dated 3/30/25, indicated for Vancomycin (antibiotic medication) 125 mg capsule, "Take 1 capsule by mouth every 6 hours for 8 days, then 1 capsule 2 times a day for 7 days, then 1 capsule daily for 7 days, then 1 capsule every other day for 7 days, then 1 capsule every 3 days for 14 days" for diagnoses: clostridium difficile colitis (C-diff, inflammation of colon caused by the bacteria clostridium difficile) infection.
A review of Resident 1's SNF orders from the hospital, dated 3/30/25, indicated for Tacrolimus 0.5 mg capsule, "Take 1 capsule (0.5 mg total) by mouth every day."
A review of Resident 1's SNF physician order, dated 3/30/25, indicated for Tacrolimus 5 mg, "Give 1 capsule by mouth one time a day for graft versus host disease."
A review of Resident 1's SNF March and April 2025 Medication Administration Records (MAR) indicated that Tacrolimus 5 mg was administered at 9:00 a.m. from 3/31/25 to 4/11/25; a total of 12 dosages in 12 days.
During an interview with Resident 1 on 5/5/25, at 12:03 p.m., he stated he was very sick, was sent to the hospital, and returned to the facility not too long ago. He also stated he had been taking Tacrolimus 0.5 mg since his transplant in 2022.
Review of Resident 1, Minimum Data Set (MDS, an assessment tool) dated 5/2/25, indicated that his Brief Interview for Mental Status (BIMS, an assessment tool that helps determine a patient's cognitive understanding) score was 15 (BIMS score of 13-15 indicates cognitively intact).
A review of the complaint information received by the California Department of Public Health dated 4/21/25, indicated the facility license nurses were administering a wrong dosage of Resident 1's Tacrolimus medication.
During an interview and record review with the Director of Nursing (DON) on 5/5/25, at 1 p.m., she confirmed that the SNF order from the hospital for Resident 1's Tacrolimus was 0.5 mg daily, but Registered Nurse (RN) A transcribed Tacrolimus 5 mg daily. The DON verified Resident 1 had taken Tacrolimus 5 mg daily from 3/31/25 to 4/11/25. The DON stated the facility's pharmacy consultant discovered that the dosage of Tacrolimus given to Resident 1 from 3/31/25 to 4/11/25 did not match the SNF order from the hospital during the monthly medication regimen review (MRR) on 4/11/25. The DON acknowledged the nurse should have transcribed the dosage of Tacrolimus accurately.
During an interview and record review with RN A on 5/5/25, at 2:45 p.m., she confirmed that the SNF order from the hospital for Resident 1's Tacrolimus was 0.5 mg daily, but she transcribed 5 mg. RN A stated she misread the dosage of Tacrolimus. RN A acknowledged she should have transcribed the dosage of Tacrolimus accurately.
A review of Resident1's Consultant Pharmacist's MRR, showed recommendations created between 4/1/25 and 4/25/25, that indicated, "For Tacrolimus: Discharge order is for Tacrolimus 0.5 mg NOT 5 mg. Please clarify immediately."
A review of Resident 1's Situation, Background, Assessment, Recommendation (SBAR, a tool use to communicate information to the resident's doctor) on 4/11/25, indicated, "Upon admission resident with order of Tacrolimus 0.5 mg & it was misread or transcribed as 5 mg," and "Recommendations of Primary clinicians: Monitor for s/s (signs and symptoms) of tacrolimus toxicity: Hives (skin rash), sleepiness, N/V (nausea/vomiting), diarrhea, uncontrollable shaking of part of the body, headache, confusion, imbalance & extreme tiredness, swelling of arms & legs, fever or other signs of infection."
A review of Resident 1's Tacrolimus level based on a laboratory sample collected on 4/7/25, with a lab result dated 4/11/25, indicated Tacrolimus by HPLC-MS/MS 25.7 nanograms per milliliter (ng/ml, a unit of measurement). Resident 1's laboratory results report of Tacrolimus level further indicated, "Therapeutic Range, Kidney transplant: 3 months and older: 5.0-15.0 ng/ml; Liver transplant: 1-12 months post-transplant: 5.0-20 ng/ml; Heart transplant: 3 months and older: 5.0-20 ng/ml. Toxic value: Greater than 25 ng/ml. Therapeutic range is based on a whole blood specimen drawn 12 hours post-dose or prior to next dose (the trough). The optimal therapeutic range for a given patient may differ from this suggested range based on the indication for therapy."
A review of Resident 1's Tacrolimus level based on a laboratory sample collected on 4/17/25, with a lab result dated 4/21/25, indicated 4.2 ng/ml.
During a telephone interview with Physician B on 6/10/25, at 12:50 p.m., she stated that she was aware of Resident 1's Tacrolimus level which was neither therapeutic nor toxic. Physician B stated she consulted with an oncologist, and the oncologist stated the level was not toxic for Resident 1.
A review of Resident 1's SBAR on 4/19/25 indicated, "Resident had episode of diarrhea with complain of fatigue (extreme tiredness), headache, SOB (shortness of breath)" and was transferred to the hospital.
A review of Resident 1's hospital Discharge Summary on 4/29/25 indicated, "Admitting diagnosis: HCAP [healthcare associated pneumonia (a pneumonia that develops in person who have recently received healthcare in nursing home, long term care facilities, and home health care)], C diff colitis and Final diagnoses included severe sepsis with acute organ dysfunction (sudden impairment or failure of one or more organs) and pneumonia.
A review of the facility's policy and procedures (P&P) titled "Medication Administration" with effective date: October 2017 indicated, "Medications are administered as prescribed ..."
The facility failed to ensure a medication was administered as prescribed by the physician for one of three sampled patients (Patient 1) when Resident 1 received 12 doses of Tacrolimus (a medication used to suppress [preventing something] the immune system) 5 milligrams (mg, unit of measurement), which was 10 times the ordered dose of 0.5 mg. This failure had the potential to result in Tacrolimus toxicity (the quality of being poisonous or harmful) for Resident 1 and could potentially contribute to Resident 1's hospitalization on 4/19/25.
This violation had a direct or immediate relationship to the health, safety, or security of the patient.