Kaiser Foundation Hospital Home Health - Novato

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview and record review, the home health agency failed to ensure infection prevention and control practices, including hand hygiene and appropriate glove use, were implemented in accordance with the agency’s infection control policy, for one of seven sampled patients (Patient 7) observed receiving home health care. Home Health Aide 1 (HHA) 1 failed to change gloves and perform hand hygiene when transitioning between showering, perineal care, incontinence care, post-shower care, and dressing. HHA 1 wore the same pair of gloves from initiation through completion of observed personal care and did not perform hand hygiene or change gloves during the transitions of care. This deficient practice had the potential to result in cross-contamination and transmission of infectious organisms to Patient 7 and other patients receiving home health aide services. FINDINGS: During a review of Patient 7’s Plan of care (POC), the POC indicated Patient 7’s start of care was 8/13/26 with diagnoses that include hypertension (high blood pressure), fall, osteoarthritis (cushioning cartilage between the bones gradually wears down) of the knee. The POC indicated Patient 7 was receiving Home Health Aide Services. During an observation on a home visit on 8/19/26 at 1:10 p.m. in Patient 7’s home, HHA 1 provided personal care to Patient 7. HHA 1 prepared designated clean and dirty areas, performed hand hygiene, allowed her hands to dry, and wore one pair of disposable gloves. From approximately 1:15 p.m. through 1:30 p.m., HHA 1 continued to wear the same pair of gloves while assisting Patient 7 with removal of clothing, and removal of a used adult diaper; showering, including washing the patient’s perineal (area around the genitals), legs, and feet; post shower transfers; application of a clean adult diaper; and dressing, including handling the patient’s socks and shoes. HHA 1 did not change gloves or perform hand hygiene when transitioning from shower and perineal/incontinence care to application of a clean adult diaper and subsequent dressing activities. During the same episode of care, HHA 1 was observed pulling and adjusting her own scrub clothing on three separate occasions while wearing the same pair of gloves. Following each occurrence, HHA 1 resumed direct patient care without changing gloves or performing hand hygiene. No glove change or additional hand hygiene was observed from initiation through completion of the observed personal care. During an interview on 8/19/26 at 1:40 p.m. with HHA 1 at the Patient 7’s Residential home lobby, HHA 1 confirmed she wore the same pair of gloves throughout the observed episode of care, did not change gloves when transitioning between care activities, and did not perform hand hygiene after completion of the shower or during subsequent transitions in care. HHA1 acknowledged the observed practice was an infection control concern. During an interview on 8/20/26 at 9 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated personnel were expected to follow the agency’s infection protocols and that hand hygiene and glove changes were vital in preventing and controlling infection. During a review of the agency’s policy and procedure titled, “Hand Hygiene”, dated October23, 2024, indicated, “…Personnel providing care in the home setting were required to follow the hand hygiene provisions established by the agency and the World Health Organization (WHO) Five Moments of Hand Hygiene: a…. performing hand hygiene upon entering the patient’s environment, and before contacting/touching a patient, b. Before performing clean procedures, c. after exposure to body fluids or risk of exposure, d. After touching a patient and e. After touching patient surroundings…””

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on interview and record review, the home health agency failed to complete an assessment in a timely manner consistent with patient’s needs for one of 17 sampled patients (Patient 13) when staff did not perform a speech therapy (a treatment that improves how a person talks, understands language, and communicates) evaluation within five days of the start of care (SOC). This failure had the potential to cause delays in providing necessary services for Patient 13. Patient 13 had a SOC date of 7/26/26 for a certification period of 7/26/26 to 9/23/26 with diagnoses that included Guillain Barre Syndrome (a condition where the immune system attacks the nerves). During a review of Patient 13’s Referral Notes, dated 7/24/26, the notes indicated the agency received the referral on 7/24/26 and indicated, “…Secondary Services Requested:…Speech Therapy…” During a review of Patient 13’s list of past visits from July to August 2026, the list indicated Patient 13’s Speech Therapy evaluation was done on 8/3/26, eight days after the SOC. During a concurrent interview and record review on 8/18/26 at 2:10 p.m. with the Quality Director (QD), the QD confirmed that Patient 13 had a SOC date of 7/26/26 and had an initial evaluation for speech therapy services on 8/3/26. The QD stated secondary services assessments should be done within five days of SOC. The QD confirmed the initial evaluation for speech therapy services for Patient 13 was done more than five days after the SOC and verified that there was no documented evidence explaining the delay or indicating whether the physician was notified. During a review of the agency’s policy and procedure (P&P) titled “INITIAL AND COMPREHENSIVE ASSESSMENT,” revised 4/16/25, the P&P indicated, “…An initial patient assessment will be performed and documented in the patient’s medical record by a registered nurse, physical therapist, occupational therapist, or speech therapist on all patients admitted to home health…Subsequent discipline assessments when ordered on the referral will be conducted no later than 5 days after the start of care date…The physician/authorizing provider will be notified of any ordered assessment visits provided beyond the 5-day window…””

“Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) Standard: Content of the comprehensive assessment. The comprehensive assessment must accurately reflect the patient’s status, and must include, at a minimum, the following information: (1) The patient’s current health, psychosocial, functional, and cognitive status; This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure that the comprehensive assessment accurately reflected the patient’s current status for one out of 17 sampled patients (Patient 17). This failure created the potential for Patient 17 to have an inaccurate medical documentation which could negatively affect treatment decisions and service delivery. Findings: A review of Patient 17’s clinical records indicated Patient 17 had a start of care date with the HHA on 8/4/26 and had diagnoses that included atherosclerosis of native arteries (hardening of arteries from plaque building up gradually causing slowed or blocked blood flow), and hyperlipidemia (high cholesterol level in the blood). A review of Patient 17’s comprehensive assessment, dated 8/4/26, indicated Patient 17 had multiple surgical wounds and was recorded as follows; Medial chest surgical wound: Wound Edge- Attached; Wound Length- 17 centimeters (cm- unit of measurement); Wound Width- 0.1 cm; Wound Depth- 0 cm, Right wound incision: Wound Edge- Attached; Wound Length- 0 cm; Wound Width- 1.5 cm; Wound Depth- 0 cm, Medial wound incision: Wound Edge- Attached; Wound Length- 0 cm; Wound Width- 1.5 cm; Wound Depth- 0 cm, Left wound incision: Wound Edge- Attached; Wound Length- 0 cm; Wound Width- 1.5 cm; Wound Depth- 0 cm. During a concurrent interview and record review on 8/19/26 at 11:38 a.m. with the Senior Director for Quality and Safety Improvement (SDQSI), Patient 17’s medical records were reviewed. The SDQSI explained that if the wound edges are well approximated and attached, the measurement would be documented as zero (0). The SDQSI agreed that since Patient 17’s medial chest wound edge was documented as attached, the width measurement should have been zero (0) to be consistent with the other wound documentations. The SDQSI stated documentation should be consistent and accurate to properly reflect the patient’s current status. A review of the agency’s policy and procedure titled, “ENTRIES INTO THE MEDICAL RECORD”, revised 3/7/23, indicated, “Home Health personnel providing direct patient care and supervisory functions have authority to make entries into the medical record. Documentation in the medical record will be timely, detailed, accurate, and reflect the care or services provided. The record format will be reviewed and updated as necessary...Entries into the medical record will be clear, concise, and specific statements of fact...””

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on interview and record review, the home health agency failed to ensure patients’ clinical records accurately reflected all medications the patients were taking for two of 17 sampled patients (Patient 13 and Patient 15) when Patient 13 and Patient 15’s active medication lists did not reconcile with the medications they were taking. This failure had the potential to expose Patient 13 and Patient 15 to possible side effects and drug interactions from taking the medications. 1a. Patient 13 had a Start of Care (SOC) date of 7/26/26 for certification period of 7/26/26 to 9/23/26 with diagnoses that included Guillain Barre Syndrome (a condition where the immune system attacks the nerves). During a review of Patient 13’s Physical Therapy Assistant (PTA) visit notes, dated 8/6/26, 8/10/26, 8/14/26, and 8/17/26, the notes indicated, “…Laxative/Stool softener [used to treat constipation] use: Yes…” During a review of Patient 13’s Speech Therapist (ST) visit note, dated 8/14/26, the note indicated, “…Laxative/Stool softener use: Yes…” During a review of Patient 13’s Active Medications, dated 8/19/26, the list did not indicate that Patient 13 was taking any laxative. The list further indicated that Patient 13 had Nicotine buccal gum (used to help stop smoking cigarettes) 2 mg (milligrams, a unit of measurement), to chew one piece of gum every 1-2 hours for 6 weeks, then 1 every 2-4 hours for 3 weeks, then 1 every 4-8 hours for 3 weeks. During an interview on 8/19/26 at 10:03 a.m. with Patient 13, Patient 13 stated that he had been taking the stool softener about 3 weeks ago. Patient 13 further stated that he did not take the Nicotine gum but was instead taking nicotine pouch (small, spit-free packets placed between the lip and gum to absorb nicotine directly to the bloodstream) 3 mg, 3 pouches as needed since Patient 13 got out of the hospital and started on home health. During a concurrent interview and record review on 8/19/26 at 10:38 a.m. with the Quality and Safety Improvement Consultant 1 (QSIC 1), the QSIC 1 confirmed that Patient 13 was receiving stool softener based on the PTA and ST visit notes, but the medication list did not indicate any stool softener and was not updated when Patient 13 started taking the medication. The QSIC 1 further confirmed that the medication list indicated Nicotine gum which Patient 13 stated he was not taking since start of care. The QSIC 1 stated that the expectation was for staff to update the medication list when there are changes or communicate the changes with the team. 1b. Patient 15 had a SOC date of 8/14/26 for certification period of 8/14/26 to 10/12/26 with diagnoses that included hypertension (high blood pressure) and Diabetes Mellitus (DM-a disorder characterized by difficulty in blood sugar control and poor wound healing). During a review of Patient 15’s physician order, dated 8/14/26, the order indicated Gabapentin (used to treat nerve pain and seizures) 300 mg take 2 capsules by mouth daily at bedtime and may take 2 capsules by mouth 4 times a day as needed, and may also take 1 capsule at bedtime as needed for anxiety or insomnia (difficulty with sleep). A review of Patient 15’s active medication list, dated 8/18/26, indicated the following medications: Gabapentin 300 mg 1 capsule by mouth daily at bedtimeMirtazapine (used to treat major depressive disorder - mood disorder that causes a persistent feeling of sadness and loss of interest) 15 mg half tablet by mouth daily at bedtimeDuring an interview on 8/19/26 at 1:32 p.m. with Patient 15’s caregiver, Patient 15’s caregiver stated Patient 15 was not taking Mirtazapine since SOC because Patient 15 was already taking Trazodone (used to treat depression). Patient 15’s caregiver further stated that Patient 15 also started taking Atorvastatin (used to lower cholesterol) 80 mg ½ tablet by mouth every evening that started on 8/16/26. During a concurrent interview and record review on 8/19/26 at 3:24 p.m. with the Quality and Safety Improvement Consultant (QSIC), the QSIC confirmed Patient 15’s physician order for gabapentin dated 8/14/26 and acknowledged that the order was not the same as the gabapentin dose on the medication list. The QSIC further confirmed that Patient 15’s Mirtazapine should have been removed from the medication list if Patient 15 was not taking it from the SOC. The QSIC also stated that if Patient 15 started taking Atorvastatin since 8/16/26, the medication list should have been updated during previous visits. The QSIC stated it was important to keep the medication list updated for patients’ safety, and it was the expectation for the medication list to be reviewed regularly and to be updated with every change. During an interview on 8/20/26 at 10:15 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated staff should check the medication list and compare it with what the patient has. The DPCS stated it was important for the medication list to be accurate so that the patient will not have any medication error. During a review of the agency’s policy and procedure (P&P) titled “MEDICATION LIST,” revised 4/10/25, the P&P indicated, “…Patients will have a current, accurate medication list in the EHR [Electronic Health Record] and will be provided with a copy of their medication list throughout the episode of care…Medication lists will be updated throughout the episode of care, including each time a medication change occurs. The medication list will reflect new medications and/or changes in current medications…””

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure services and treatments written in the plan of care are administered only as ordered by a physician or allowed practitioner for two out of 17 sampled patients (Patient 3 and Patient 6). This failure compromised the agency’s ability to ensure patient needs were coordinated and delivered according to physician orders. 1b. Patient 6 had a SOC date of 5/26/26 for certification period of 5/26/26 to 7/24/26 with diagnoses that included Juvenile Osteochondritis of Spine (a disorder that causes the backbone to wedge into a triangular shape during adolescence, leading to an abnormal forward curve of the upper back). A review of Patient 6’s POC, dated 5/26/26, indicated Patient 6’s POC was signed on 7/29/26, over two months after the start of care. During a concurrent interview and record review on 8/19/26 at 12:45 p.m. with the Quality Director (QD), the QD confirmed Patient 6 had a SOC date of 5/26/26 and was discharged on 6/15/26. The QD also confirmed that Patient 6’s POC was signed by the physician on 7/29/26, over two months after the SOC, and more than a month after Patient 6’s discharge from the agency. The QD stated that POCs should be signed within 30 days of SOC. During a concurrent interview and record review on 8/19/26 at 1:05 p.m. with the Quality and Safety Improvement Consultant (QSIC), the QSIC confirmed that Patient 6’s POC was signed on 7/29/26 and stated that POCs should be signed within 30 days of SOC. The QSIC stated it was important for the physician to sign the POC within 30 days because the POC was where clinicians relied on the services they were providing and so that the physician was aware of the plan on how to meet the patient’s care goals. During an interview on 8/20/26 at 10:15 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated that the expectation was for the POC to be signed by the physician within 30 days of POC. The DPCS stated it was important because the clinicians cannot provide the care without the physician’s orders. Findings: 1. A review of Patient 3’s clinical records indicated Patient 3 had a start of care date with the HHA on 6/8/26 and had diagnoses that included transient cerebral ischemic attack (TIA- often called a mini-stroke, a temporary drop in blood flow to a part of the brain), and diabetes (elevated sugar in the blood). A review of Patient 3’s plan of care, dated 6/8/26, indicated Patient 3’s plan of care was signed by a physician on 8/17/26, which was more than 2 months from the start of care date. A review of Patient 3’s discharge summary, dated 7/2/26, indicated Patient 3 was discharged from the agency on 7/2/26. During a concurrent interview and record review on 8/18/26 at 12:29 p.m. with the Senior Director for Quality and Safety Improvement (SDQSI), Patient 3’s medical records were reviewed. The SDQSI confirmed that Patient 3’s plan of care was signed by a physician on 8/17/26, which was more than 2 months from the start of care date. The SDQSI stated their policy is that all patients plan of care should be reviewed and signed by a physician within 30 days from the patient’s start of care. A review of the agency’s policy and procedure titled, “PHYSICIAN/AUTHORIZING PROVIDER PARTICIPATION IN PLAN OF CARE”, revised 8/24/18, indicated, “A physician/authorizing provider will direct the care of every Home Health patient admitted for service. The physician/authorizing provider responsible for home health services and issuing orders related to the condition(s) that led to the initiation of home health services holds overall responsibility for the patient’s plan of care. Drugs, services, and treatments are administered only as ordered by the physician/authorizing provider who is responsible for the home health plan of care...The physician/authorizing provider responsible for the plan of care will sign the plan of care/treatment within 30 working days of the start of care...Each physician/authorizing provider writing orders updating the plan of care will sign the orders within 30 working days of the orders being written...””