Inspector’s narrative
What the inspector wrote
483.25 Quality of care
Quality of care is a fundamental principle that applies to all treatment and care provided to facility residents. Based on the comprehensive assessment of a resident, the facility must ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the residents' choices.
The facility must ensure that its
§483.45(f)(2) Residents are free of any significant medication errors.
§72523(a) Patient Care Policies and Procedures.
(a)Written patient care policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved.
On 8/27/2025, the California Department of Health (CDPH) received a complaint alleging a resident (Resident 10) was administered a medication in error.
On 9/2/2025 CDPH conducted an unannounced visit to investigate the complaint allegation. Upon investigation, CDPH determined Resident 1 had a history of an adverse reaction (confusion) to Baclofen (a medication that relaxes the muscles to relieve spasm, tightness, and cramps). The discharge instructions from General Acute Care Hospital (GACH) 1 were conflicting and led to licensed nurses at the facility administering Baclofen to Resident 10 over a period of three days.
The facility failed to:
1. Ensure Registered Nurse (RN) 1 reviewed Resident 10's entire Discharge Instructions from GACH 1 dated 8/14/2025 and 8/15/2025 for accuracy prior to transcribing the instructions into the orders in Resident 10's chart.
2. Ensure RN 1 clarified conflicting instructions in GACH 1's Discharge Instructions dated 8/14/2025 with Resident 10's physician. One Discharge Instruction dated 8/14/2025 advised against using Baclofen due to confusion by indicating "do not use Baclofen since caused confusion," the same Discharge Instruction indicated to administer Baclofen 10 milligrams ([mg] a metric unit of measurement, used for medication dosage and/or amount), give half of the tablet (5 mg), three times daily, while another Discharge Instructions dated 8/15/2025, indicated to continue Baclofen 10 mg, half tablet (5.0 mg) three times daily.
3. Ensure RN 1 did not administer five doses of Baclofen over a period of three days to Resident 10 without reconciling the orders with Resident 10's physician.
4. Ensure RN 1 followed the facility's Policy and Procedure (P/P), titled, "Medication Orders Non-Controlled Medication Order Documentation" revised 8/2019, which indicated nurses are to verify the GACH's order with the attending physician before medication was transcribed for administration.
As a result of these deficient practices, Resident 10 received Baclofen 5 mg from 8/15/2025 through 8/17/2025 (a total of five doses), experienced shortness of breath (SOB), an elevated blood pressure (BP), generalized weakness and increased confusion. Resident 10 was transferred to GACH 1, where she was diagnosed with acute toxic encephalopathy (a condition characterized by sudden and severe brain dysfunction caused by exposure to toxic substances) and was dialyzed (treatment to remove waste products and excess fluid from the blood when the kidneys are unable to do so).
A review of Resident 10's Admission Record (Face Sheet), indicated Resident 10, an 81 year old female, was admitted to the facility on 8/15/2025 with diagnoses including osteoarthritis, end stage renal disease (ESRD) and dependence on hemodialysis.
A review of Resident 10's Minimum Data Set ([MDS] a resident assessment tool) dated 8/17/2025, indicated Resident 10 was able to make decisions that were reasonable and consistent. The MDS indicated Resident 10 required a one person assist to complete her activities of daily living ([ADLs] routine tasks/activities such as bathing, dressing and toileting a person performs daily to care for themselves).
A review of GACH 1's Discharge Summary dated 8/14/2025 and timed at 2:09 p.m., indicated to discharge Resident 10 to the facility with the following instructions:
a. Do not use Baclofen since the medication caused confusion.
b. Administer Baclofen 10 mg, give half of the tablet (5 mg), three times daily.
A review of GACH 1's Discharge Instructions, dated 8/15/2025 and timed 8:44 a.m., indicated to administer Baclofen 10 mg, give half of the tablet (5.0 mg), three times daily.
A review of Resident 10's Clinical Record indicated there was no written documentation to indicate the admitting nurse (RN 1) notified Resident 10's physician to clarify conflicting instructions to determine if Baclofen should or should not be administered to Resident 10.
A review of Resident 10's Physician's Order Summary, dated 8/15/2025 indicated to administer Baclofen 10 mg, give half of the tablet (5.0 mg) three times a day for muscle spasms.
A review of Resident 10's Medication Administration Record (MAR) dated 8/2025, indicated Resident 10 was given five doses of Baclofen 5.0 mg from 8/15/2025 to 8/17/2025.
A review of Resident 10's Change of Condition Evaluation (COC) dated 8/17/2025 and timed at 8:04 a.m., indicated Resident 10 was observed with SOB, weakness, confusion and drowsiness. Resident 10's B/P was 180/110 millimeters of mercury (mmhg) and her oxygen saturation ([O2 Sat] oxygen level in the body that indicates the body has enough oxygen supply, normal range of 95 to 100%) ranged from 92% to 94 % on room air. The COC indicated Resident 10's physician was notified of Resident 10's COC on 8/17/2025 at 8:45 a.m., and an order was obtained to transfer Resident 10 to GACH 2 by paramedics.
A review of the Resident 10's Physician's Order Summary, dated 8/17/2025, indicated to call 911 for Resident 10 due to SOB, elevated B/P and generalized weakness.
A review of GACH 2's Emergency Department (ED) Note dated 8/17/2025 and timed at 10:28 a.m., indicated Resident 10 was brought to the emergency room by the paramedics because of dizziness, fatigue, and nausea with a B/P of 182/69.
A review of GACH 2's History and Physical (H&P) dated 8/17/2025 and timed at 5:08 p.m., indicated Resident 10 presented at the emergency room (ER) with new onset altered mental status (AMS), dizziness, nausea and weakness after confirmed administration of Baclofen at the facility. The H&P indicated a few weeks ago, Resident 10 was hemodialyzed at another GACH (GACH and date unknown) related to Baclofen toxicity (the extent to which a substance is poisonous and harmful to living thing). The H&P indicated Resident 10 might have received "a second unintentional dose" of Baclofen and was placed on delirium precautions (simple actions used to help a confused person to stay calm and oriented), frequent reorientation, and was admitted for acute encephalopathy, likely due to Baclofen toxicity.
A review of GACH 2's Nephrology Consultation Notes, dated 8/17/2025 and timed at 6:49 p.m., indicated Resident 10 would undergo hemodialysis due to Baclofen toxicity.
A review of GACH 2's Discharge Summary dated 8/18/2025 and timed at 2:44 p.m., indicated Resident 10 had a diagnosis of acute toxin encephalopathy.
A review of Resident 10's Skilled Nursing Facility H&P dated 8/17/2025 and timed at 12:45 p.m., indicated the facility's nursing department restarted Resident 10's home medications including Baclofen. The H&P indicated Resident 10's medications were administered to Resident 10 without clarifying the discharge medication list with Resident 10's primary care physician.
During a telephone interview on 8/29/2025 at 12:23 p.m., Resident 10's Family Member (FM) 1 stated Resident 1 was transferred to the facility from GACH 1 on 8/15/2025 with instructions not to give Resident 10 Baclofen because it made Resident 10 feel weak and confused. On 8/17/2025 Resident 10 called her complaining she did not feel well, and the facility had given her Baclofen. FM 1 stated she arrived at the facility at 10 a.m., and Resident 10 had been transferred to a GACH 2 due to dizziness, fatigue, SOB and hallucinations. FM 1 stated when she (FM 1) arrived at GACH 2, GACH 2 had not been informed by the facility that Resident 10 was given Baclofen or that it caused Resident 10 confusion. FM 1 stated she notified GACH 2 and GACH 2 immediately performed dialysis on Resident 10. Resident 10 could have died because Resident 10's kidneys no longer functioned.
During an interview on 9/5/2025 at 4:11 p.m., RN 1 stated when she received Resident 10's admission papers from GACH 1 on 8/15/2025, she determined Resident 10 was not allergic to any medication and transcribed/carried over the discharge medications listed on the GACH 1's Discharge Instructions to Resident 10's medical record and the MAR. RN 1 stated she did not call Resident 10's physician to verify and/or clarify Resident 10's discharge medications or instructions because the physicians at the GACH normally prepare the discharge instructions and the primary care physician at the facility could see the orders in Resident 10's medical record.
During an interview on 9/8/2025 at 11:57 a.m., RN 1 stated after reviewing GACH 1's Discharge Summary dated 8/14/2025, she did not see the instructions indicating Baclofen should not be given to Resident 10 due to confusion. RN 1 stated if she had reviewed GACH 1's Discharge Summary, compared discharge instructions, checked the medication list, and clarified the instructions with Resident 10's physician, Resident 10 would not have been given Baclofen, which caused Resident 1 to have a COC.
During a telephone interview on 9/8/2025 at 12:32 p.m., RN 3 stated on 8/17/2025 during the 7 a.m. to 3 p.m. shift, she received an endorsement from the outgoing nurse (11 p.m. to 7 a.m.) that Resident 10 was feeling weak and dizzy. RN 3 stated she assessed Resident 10 at the start of her shift (7 a.m. to 3 p.m. shift), and Resident 10 complained of right buttock pain, rated 3 out of 10 on an eleven point pain rating scale (0=no pain, 1-3=mild pain, 4-6=moderate pain, and 7-9=severe pain, and 10=worst imaginable pain). RN 3 stated she applied a lidocaine patch (a topical adhesive patch containing lidocaine, used for pain) to the affected site and administered Baclofen 5.0 mg to Resident 10. RN 3 stated at approximately 8:30 a.m., Resident 10 still felt weak, dizzy, and become more lethargic, was not talking, had a high B/P, was SOB, and her O2 Sat was 92% while receiving supplemental O2 (amount of O2 unknown). RN 3 stated she administered an anti-hypertensive medication to Resident 10, but her B/P remained high, she (RN 3) then called Resident 10's physician and received an order to call the paramedics.
During an interview on 9/8/2025 at 12:47 p.m., the facility's Senior Nurse Executive (SNE) stated the admission process included checking the discharge papers from the GACH including the doctor's discharge summary, discharge instructions and the medication list. The SNE stated it was the responsibility of the admitting nurse to call Resident 10's physician to verify and/or reconcile the residents' medications to ensure the residents' prescribed medications were accurate.
During a telephone interview on 9/8/2025 at 1 p.m., the facility's Pharmacist stated Baclofen causes central nervous system depression, dizziness and confusion. The Pharmacist stated physicians should be aware of the side effects of this medication and adjust the dose and/or stop the medication based on the residents' kidney function, response and/or tolerance to the medication. The Pharmacist stated Baclofen cannot be eliminated effectively from the body when the kidney function is impaired, which could increase a resident's risk of side effects associated with the medication.
During a telephone interview on 9/8/2025 at 2:51 p.m., the on-call physician, who covered for Resident 10's attending physician, stated the admitting nurse should have contacted Resident 1's attending physician to discuss the residents' Discharge Summary and discharge medications from GACH 1 to identify and/or resolve any inconsistencies and discrepancies.
During a telephone interview on 9/8/2025 at 4:28 p.m., GACH 2's Nephrologist stated Baclofen was not nephrotoxic (poisonous to the kidneys), but it could accumulate in the blood when the kidney were impaired and cause a resident to have an altered level of consciousness ([ALOC] a change in a patient's state of awareness [ability to relate to self and the environment] and arousal [alertness]).
During a telephone interview on 9/9/2025 at 1:20 p.m., the facility's Medical Director stated it was the facility's policy and common practice for the doctors and the licensed nurses to conduct a thorough reconciliation of the residents' discharge medications and review of discharge instructions including the discharge summary to clarify and/or decide the residents' treatment and medications. The Medical Director stated licensed nurses were not to transcribe any medication order without the approval of the primary care physician to ensure the residents were free from inappropriate medications that could affect their safety and wellbeing.
During an interview on 9/10/2025 at 11 a.m., the Chief Clinical Officer (CCO) stated Resident 10's COC and the life-threatening complications could have been prevented if the admission process was followed.
During an interview on 9/10/2025 at 12:33 p.m., the Administrator (ADM) stated the failure to reconcile the medications with Resident 10's physician should not have happened because the facility has ongoing P/Ps related to admission medication reconciliation.
According to Mayo Clinic, "BACLOFEN (Oral Route)- Side effects and Dosage" dated 9/1/2025 indicated Baclofen was used to help relax the muscles to relieve spasms and cramping by acting on the central nervous system to produce muscle relaxant effects. This medication must be prescribed and used with caution if anyone has an allergy or unusual reaction to it and limit use in elderly because of age-related kidney, liver or heart problems that may likely cause side effects of hallucination, confusion, mental depression, and severe drowsiness. The presence of a medical problem such as a kidney disease may increase the effects of the medication because of slower removal of medicine from the body and should be avoided because of increased risk of serious brain problems such as encephalopathy (a medical condition of the brain affected by some agent or condition such as toxins in the blood).
https://www.mayoclinic.org
A review of the facility's P/P titled, "Medication Orders Non Controlled Medication Order Documentation" revised 8/2019, indicated the written transfer orders (sent with a resident by a hospital or other healthcare facility) shall be verified with the current order attending physician before medications are administered and the nurse who transcribes the orders must document in the admission form the date, time and by whom the orders were noted.
The facility failed to:
1. Ensure RN 1 reviewed Resident 10's entire Discharge Instructions from GACH 1 dated 8/14/2025 and 8/15/2025 for accuracy prior to transcribing them into the orders in Resident 10's chart.
2. Ensure RN 1 clarified conflicting instructions in GACH 1's Discharge Instructions dated 8/14/2025 with Resident 10's physician. One Discharge Instruction dated 8/14/2025 advised against using Baclofen due to confusion by indicating "do not use Baclofen since caused confusion," the same Discharge Instruction indicated to administer Baclofen 10 mg, give half of the tablet (5 mg), three times daily, while another Discharge Instructions dated 8/15/2025, indicated to continue Baclofen 10 mg, half tablet (5.0 mg) three times daily.
3. Ensure RN 1 did not administer five doses of Baclofen over a period of three days to Resident 10 without reconciling the orders with Resident 10's physician.
4. Ensure RN 1 followed the facility's P/P, titled, "Medication Orders Non-Controlled Medication Order Documentation" revised 8/2019, which indicated nurses are to verify the GACH's order with the attending physician before medication was transcribed for administration.
As a result of these deficient practices, Resident 10 received Baclofen 5 mg from 8/15/2025 through 8/17/2025, experienced SOB, an elevated B