Every finding on record at Miracle Home Health Care, Inc

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey from 7/16/2024 to 7/19/2024. Complaint Intake Numbers: 101797 107945 108166 Census: 817 Unduplicated admissions: 5561 Sample Size: 17 Home Visits: 7 Closed Record review: 5 All Conditions of Participation were met. Eleven standard deficiencies were identified during the CV survey.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review the Registered Nurse (RN) failed to conduct an initial assessment for one of seventeen sampled patients (Patient 3). This failure resulted in not identifying the complete needs of the patient to determine the interventions needed for the patient. A record review of Patient 3’s “Patient Profile” indicated a start of care date on 7/4/2024, with a primary diagnosis of gangrene (death of body tissue due to no blood flow) to the left lower leg. During an interview on 7/18/2024, at 10 a.m., Licensed Vocational Nurse 4 (LVN 4) stated the main purpose of the visit for Patient 3 was to provide wound care on the left lower leg due to an amputation (removal of a limb). During an interview at the home visit on 7/18/2024, at 10:03 a.m., Patient 3 stated he goes to dialysis (a process of removing body waste and fluid from the body when the kidneys do not work), three times a week. During a concurrent observation, and interview, during the home visit on 7/18/2024, at 10:50 a.m., LVN 3 performed a body assessment (examination). A catheter (tube) was observed on Patient 3’s right upper chest. LVN 3 stated this was the dialysis catheter. During a concurrent interview and record review on 7/19/2024, at 12:24 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 3’s record titled, “OASIS-E Start of Care”, dated 7/4/2024. The DPCS stated the nurse documented “hemodialysis”, without the location of the shunt. The DPCS stated the nurse needed to document about the dialysis catheter because it needed to be included in the plan of care, and to monitor the catheter for complications. The importance of assessing the catheter was because it can lead to life threatening conditions such as severe bleeding if it comes out. The catheter was very close to the heart, so there can be complications with the heart and lungs. The nurses needed to know about the catheter so they can assess the catheter for signs of infection too. The DPCS stated the plan of care did not have any interventions for the dialysis catheter. During a record review of facility’s policy and procedure titled “Initial and Comprehensive Assessment”, revised November 2021, indicated “The assessment will be patient-specific and comprehensive to include the patients need for home health care, rehabilitative care, social services, and discharge planning. This assessment will measure patient outcomes from data collected at the start of care and at the following defined intervals thereafter: significant change in condition per the agency’s policy and definition. Patients’ functional status, including but not limited to, the degree of self-care, and the amount and level of assistance needed in the following areas: The patients medical and psychosocial history, including pertinent diagnoses and prognosis. Any identified symptoms of pain. Past medical and surgical care including dates of onset/exacerbation.”

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 (HHA) failed to complete the comprehensive assessment for one of seventeen sample patients (Patient 3) within five days of admission. This failure had the potential to result in the delay to identify the patient's care needs and provision of services. A record review of Patient 3’s “Patient Profile”, indicated a start of care date on 7/4/2024, with a primary diagnosis of gangrene (death of body tissue due to no blood flow) to the left lower leg. During an interview at the home visit on 7/18/2024, at 10:03 a.m., Patient 3 stated he was informed the day prior, on 7/17/2024, that Physical Therapy (PT) services would visit him today, 7/18/2024. During an interview on 7/19/2024, the Director of Patient Care Services (DPCS) stated PT services was late and resulted in a big delay of care. The DPCS stated the reason the PT evaluation was late was due to insurance processes. The DPCS stated the need for PT services was determined on the start of care visit, on 7/4/2024. The DPCS stated the PT evaluation needed to be done by 7/9/2024. Patient 3 had as a result of the delay in care was possible weakness of the leg affected, possible falls, and possible delay in gaining strength.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(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 evaluate and perform pain reassessment in accordance with the agency’s policies and procedure for one of seventeen sampled patients (Patient 9). This deficient practice has the potential to result in ineffective pain management. Findings: During a review of Patient 9’s Patient Profile sheet indicated a start of care date of 7/9/2024, with diagnoses including unspecified open wound, left lower leg, and cellulitis (bacterial infection of the skin) of left and right lower limb. During a review of Patient 9's Home Health Certification and Plan of Care (POC) for the certification period starting from 7/9/2024 to 9/6/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks. The skilled was to conduct an assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care on left lower leg, and to assess pain for location, character, intensity using the scale of 1-10 with 10 as the most intense level. The POC further indicated for the SN to report to the physician if the patient experiences pain levels greater than 6/10 or if the pain significantly impacts the patient’s ability to perform normal activities. During a concurrent interview and record review on 7/19/2024, at 11:55 a.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 9’s record titled “LVN (licensed vocational nurse) Wound Care Visit Note”, dated 7/11/2024. The DPCS stated Patient 9 had a pain level 7/10 or very intense pain on left lower leg. The DPCS stated and acknowledged there was no documented evidence Patient 9’s pain level was reassessed after a pain intervention and before the end of the SN visit. DPCS stated the agency’s SN should have reassessed patient’s pain to know if the pain intervention was effective. During a review of the agency’s policy and procedure titled, "Pain Assessment", revised November 2020, indicated all patients will receive at least an initial pain assessment. When the patient or the clinician identifies pain, the following in-depth pain assessment information will be obtained whenever possible: pain intensity using a rating scale (on a scale of 0 – 10: 0=no pain; 10=unbearable pain), pain location, pain quality, onset, duration, alleviating and aggravating factors, and present pain management regimen and effectiveness.

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 observation, interview, and record review, the Home Health Agency (HHA) failed to review, update, and document the patients' currently used medications and treatments for four of seventeen sample patients (Patient 2, Patient 7, Patient 12, and Patient 15). This failure had the potential to result in placing the patients at risk of drug-to-drug interaction and harm by not knowing which medications they were taking. This failure resulted in patients not having an accurate and comprehensive medical list that could place the patients at risk for medication errors and adverse drug reactions. 2. During a review of Patient 7’s Patient Profile sheet indicated a start of care date of 6/12/2024, with diagnoses including mechanical complication of internal fixation (the method of physically reconnecting the bones) of bone of left lower leg, type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), and essential hypertension (high blood pressure). During a review of Patient 7's Home Health Certification and Plan of Care for the certification period starting from 6/12/2024 to 8/10/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks, for skilled assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care to left foot, and to instruct patient/caregiver on compliance to prescribed medications, frequency, refills and dosages. On 7/17/2024, at 10:45 a.m., a joint home visit was conducted at Patient 7’s residence with the licensed vocational nurse (LVN 1). Patient 7 was observed awake, alert, and oriented x 3 (to person, place, and time). On 7/17/2024, at 11:10 a.m., during a review of Patient 7’s current medication with LVN 1, a bottle of Ferosul (an iron supplement used to treat or prevent low blood levels of iron) 325 mg 1 tablet oral daily could not be found. However, the medication list provided by the HHA indicated Patient 7 was still taking the medication. During a concurrent interview, Patient 7 stated he was not taking Ferosul anymore for several weeks. During an interview on 7/19/2024, at 11:55 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated nursing staff need to review patient’s current medication on every nurse visit and update the medication list in the patient’s clinical record to prevent medication errors. During a review of the agency’s policy and procedure titled, “Medication Profile”, revised November 2020, indicated patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. 1. A record review of Patient 2’s “Patient Profile”, indicated a start of care date on 4/4/2024, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024, at 2:50 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 2 was taking. The following medications were not listed in Patient 2’s record titled, “Medication Profile”, printed on 7/16/2024: Meloxicam (to treat arthritis-join stiffening, causing pain) 7.5 mg (mg-milligram, unit of measurement), 1 tablet by mouth daily. Omeprazole (to treat too much stomach acid) 20 mg 1 capsule by mouth daily. LVN 3 stated the medication profile needed to be updated in the electronic medical record (EMR) every Sunday. During an interview on 7/17/2024, at 3:08 p.m., LVN 3 stated there were two different medication profile in the patients’ home, which did not have the same medications listed. LVN 3 stated this can create confusion for the patient. If the patient were to need paramedic services, the list is what the paramedics rely on. If there are two lists, paramedics do not know which list is accurate. 2. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. The form also indicated “Medications: Normal Saline… Losartan (medication to treat high blood pressure) …Metformin (medication to treat high blood sugar) … atorvastatin (medication to treat high cholesterol) … Lastly, the form indicated Patient 12 had a wound vacuum ordered.” During a record review of Patient 12’s medical record form titled “Physician Order” dated 7/13/2024, indicated “SN to discontinue the wound vac treatment”. The form also indicated Patient 12 was ordered Santyl ointment as part of his wound treatment order. During a record review of Patient 12’s medical record form titled “Medication Profile” received from HHA on 7/16/2024 as requested, the form indicated Patient 12 was ordered Atorvastatin, Losartan, Metformin, and normal saline. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024 at 1 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 12 was taking. The following medications were not listed in Patient 12’s record titled, “Medication Profile”, printed on 7/16/2024: Santyl – ointment medication for wounds Aspirin – blood thinner/pain medication Multivitamin Jardiance – medication for high blood sugar Patient 12 stated he has been taking Jardiance 10mg daily since 7/3/2024. LVN3 stated he reconciled Patient 12’s medication yesterday (7/16/2024) or the day before yesterday (7/15/2024). LVN3 stated he reconciles Patient 12’s medications weekly. LVN3 stated medications need to be reconciled to prevent medication errors. 3. During a review of Patient 15’s medical record form title “Home Health Certification and Plan of Care” dated from 7/5/2024 – 9/2/2024, indicated a start of care date of 7/5/2024 with principal diagnosis of “hemiplegia following cerebral infarct affecting right dominant side”. The form also indicated “Medications: Cephalexin (antibiotic), Sevelamer (medication to treat high phosphate blood level), levetiracetam (medication to treat seizures) and Carvedilol (medication to treat high blood pressure).” During a record review of Patient 15’s medical record form titled “Medication Profile” received from HHA on 7/19/2024 as requested, the form indicated “Cephalexin… Last day 7/7 by mouth (PO).” During a concurrent interview and record review on 7/19/2024 at 2:50 p.m. with the Director of Patient Care Services Designee (DD) of Patient 15’s Electronic Medical Record (EMR), DD stated Patient 15’s medication profile should have been reconciliation the week of 7/7/2024, but that week Patient 15 had a missed skilled nurse visit. DD stated it was important to reconcile Patient 15’s medication to make sure the patient finished the course of antibiotics and to prevent medication errors. During an interview on 7/18/2024 at 9:30 a.m. with DD, DD stated skilled nursing are to review and reconcile patients’ medications once a week. DD stated the visiting skilled nurse who reconciles the patients’ medications access their Electronic Medical Record (EMR) and update the patient’s medication list once the visit is complete. DD stated it was their responsibility to ensure patients take the ordered medications to prevent adverse effects from taking the wrong medication or dosage. During a record review of facility’s policy and procedure titled “Medication Profile” revised November 2020, indicated “During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure that the patient and family/caregiver, as well as other clinicians, understand the medication regimen. Each patient and/or family/caregiver will receive appropriate written material for specific medication he/she is receiving. The material will contain information on actions of the medications, potential side effects, contraindications, and any special instructions when taking the specific medication.

Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This STANDARD is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the plan of care (POC, an individualized plan of care that summarizes the patients’ health condition, specific care needs, current treatments, and the disciplines providing the services) was implemented for two of seventeen sampled patients (Patient 1 and Patient 15). This failure had the potential to result in health status decline. 1. A record review of Patient 1’s “Patient Profile” indicated a start of care date on 5/4/2024, with a primary diagnosis of encounter for change or removal of surgical wound dressing. A record review of Patient 1’s “Home Health Certification and Plan of Care”, for certification period 7/3/2024 to 8/31/2024, indicated the skilled nurse was to continue to assess wound response to treatment, signs and symptoms of wound infection. During a concurrent interview and record review on 7/19/204, at 4:08 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 1’s record titled, “LVN Wound Care Visit Note”, dated 7/8/2024. The DPCS stated the wound was due to be assessed on this visit and the record indicated it had not been assessed. The DPCS stated the record included a picture of the wound, but this was not enough to know if the wound was getting better or worse. The importance of assessing the wound was to prevent complication and further skin breakdown, wound infection, and other related complications. 2. During a record review of Patient 15’s “Patient Profile” indicated a start of care date on 7/5/2024, with a primary diagnosis of cerebral infarct, unspecified (disruption in blood flow to the brain). During a record review of Patient 15’s “Home Health Certification and Plan of Care”, for certification period 7/5/2024 to 9/2/2024, indicated the skilled nurse was to complete home visits once a week for nine weeks. During a concurrent interview and record review on 7/19/204, at 2:50 p.m., with the Director of Patient Care Services Designee (DD) of Patient 15’s medical record, DD stated Patient 15 did not have a skilled nurse visit the week of 7/7/2024. DD stated there were no communication notes to indicate the reason for the missed visit. During a record review of facility’s policy and procedure titled “Missed Visits” dated 1/28/2022, indicated “Missed visits will be communicated to the clinical supervisor and the patient’s physician. A missed visit will be rescheduled the same week if possible. Missed visit will be documented in the clinical record. During a record review of facility’s policy and procedure titled “Wound Care Policy” revised November 2020, indicated “wounds are to be measured weekly by clinician.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure three of seventeen sampled patients (Patient 3, Patient 7, and Patient 12) plans of care (POC) included interventions needed to monitor the patients' health status. This failure had the potential to result in health status decline related to the omission of the necessary interventions needed to reach the patient goals and prevent re-hospitalization. 2. During a review of Patient 7’s Patient Profile sheet indicated a start of care date of 6/12/2024, with diagnoses including mechanical complication of internal fixation (the method of physically reconnecting the bones) of bone of left lower leg, type 2 diabetes mellitus (a condition that results in too much sugar circulating in the bloodstream), and essential hypertension (high blood pressure). During a review of Patient 7’s OASIS (Outcome and Assessment Information Set - patient specific standardized data set that measures quality and outcomes) Resumption of Care assessment dated 6/25/2024, indicated Patient 7 had a PICC line (or peripherally inserted central catheter, is a thin, flexible tube that is inserted into a vein in the upper arm and guided into a large vein above the right side of the heart for long-term IV [intravenous, or into the vein] antibiotics [medicines that fight bacterial infections], nutrition, medications, and blood draws. During a review of Patient 7's Home Health Certification and Plan of Care (POC) for the certification period starting from 6/12/2024 to 8/10/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks, for skilled assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care to left foot, and to instruct patient/caregiver on compliance to prescribed medications, frequency, refills and dosages. However, the POC did not include the necessary care, assessment, and monitoring for complications of Patient 7’s PICC line. During an interview on 7/19/2024, at 11:55 a.m. with the Director of Patient Care Services (DPCS), the DPCS stated and acknowledged Patient 7’s PICC line was not addressed in the POC. The DPCS stated the POC should have included catheter assessment and monitoring for complications like bleeding and signs of infection on every nurse visit. 1. A record review of Patient 3’s “Patient Profile”, indicated a start of care date on 7/4/2024, with a primary diagnosis of gangrene (death of body tissue due to no blood flow). During an interview at the home visit on 7/18/2024, at 10:03 a.m., Patient 3 stated he goes to dialysis (a process of removing body waste and fluid from the body when the kidneys do not work), three times a week. During a concurrent observation, and interview of the home visit on 7/18/2024, at 10:50 a.m., LVN 3 performed a body assessment (examination). A catheter (tube) was observed on Patient 3’s right upper chest. LVN 3 stated this was the dialysis catheter. During a concurrent interview and record review on 7/19/2024, at 12:24 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 3’s record titled, “OASIS-E Start of Care”, dated 7/4/2024. The DPCS stated the nurse documented “hemodialysis”, without the location of the shunt. The DPCS stated the nurse needed to document about the dialysis catheter because it needed to be included in the plan of care, to monitor the catheter for complications. The importance of assessing the catheter was because it can lead to life threatening conditions such as severe bleeding, if it comes out. The catheter is very close to the heart, so there can be complications with the heart and lungs. The nurses needed to know about the catheter so they can assess the catheter for signs of infection too. The DPCS stated the plan of care did not have any interventions for the dialysis catheter. During a concurrent interview and record review on 7/19/2024, at 12:25 p.m., the DPCS reviewed Patient 3’s record titled, “Home Health Certification and Plan of Care”, dated 7/4/2024 to 9/1/2024. The DPCS stated the dialysis catheter was not addressed in the POC. 2. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. The form also indicated Patient 12 had a wound vacuum ordered. During a record review of Patient 12’s medical record form titled “Physician Order” dated 7/13/2024, indicated “SN to discontinue the wound vac treatment”. The form also indicated Patient 12 was ordered Santyl ointment as part of his wound treatment order. During a record review of Patient 12’s medical record form titled “Medication Profile” received from HHA on 7/16/2024 as requested, the form indicated Patient 12 was ordered Atorvastatin, Losartan, Metformin, and normal saline. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024 at 1 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 12 was taking. The following medications were not listed in Patient 12’s record titled, “Medication Profile”, printed on 7/16/2024: Santyl – ointment medication for wounds. Patient 12 stated his right foot wound vacuum was discontinued on 7/11/2024 and started using Santyl at that time. During an interview on 7/18/2024 at 10:28 a.m. with DPCS, DPCS stated patients plans of care are not amended or updated when there is a new or revised doctor order. DPCS stated they used supplemented physician orders. The HHA failed to update Patient 12’s wound treatment plan. During a record review of facility’s policy and procedure titled “Care Planning Process” revised November 2021, indicated “A written individualized plan of care will be initiated… Based on the assessment and conclusions, the plan of care will include, but not be limited to…patient specific interventions and education; reasonable, measurable, and individualized goals and outcomes identified by the organization and the patient anticipated to occur as a result of implementing and coordinating the plan of care.”

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, The Home Health Agency (HHA) failed to ensure all doctor’s orders were recorded in the plan of care (POC) for two of seventeen sampled patients (Patient 2 and Patient 12). This failure had the potential to result in errors in assessment or treatments due to the POC not reflecting the most recent doctor’s orders. 1. A record review of Patient 2’s “Patient Profile”, indicated a start of care date on 4/4/2024, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. During an interview at the home visit on 7/17/2024, at 2:30 p.m., Licensed Vocational Nurse 3 (LVN 3) stated the wound orders was on hold because Patient 2 had a procedure done on it and the doctor did not want the HHA to do anything with the left leg. During an observation of the home visit on 7/17/2024, at 2:32 p.m., Patient 2 was sitting in a lounge chair. There was a bandage on the left leg, wrapped from ankle to just below the knee. The bandage had the words written on it, “do not remove”. During a concurrent interview and record review on 7/18/2024, at 2:07 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 2’s record titled, “Physician Order”, dated 7/1/2024. The DPCS stated this was the order to hold the wound treatment for 3 weeks. During a concurrent interview and record review on 7/18/2024, at 2:08 p.m., the DPCS reviewed Patient 2’s record titled, “Physician Order”, dated 7/11/2024. The DPCS stated the order indicated for the HHA to do an evaluation to report the necessity of home health. During a concurrent interview and record review on 7/18/2024, at 2:17 p.m., the DPCS reviewed Patient 2’s record titled, “Physician Order”, dated 7/12/2024. The DPCS stated the order indicated a change of nursing visit frequency to once a week for four weeks, and to hold the wound treatment. The DPCS stated the Plan of Care (POC) was not updated to reflect the most recent doctor’s orders. The DPCS stated the HHA used supplemental orders to update the plan of care, but those orders did not directly go into the plan of care. The DPCS stated the plan of case should be updated with the most updated doctor’s orders in case other staff take care of the patient, they know what do to. During a concurrent interview and record review on 7/18/2024, at 2:20 p.m., the DPCS reviewed Patient 2’s record titled, “Home Health Certification and Plan of Care-Recertification of Continuing Need for Care”, dated 6/3/2024 to 8/1/2024. The record indicated for the skilled nurse to do wound care three times a week for nine weeks. The DPCS stated the POC did not have the most updated skilled nurse visit frequency and wound treatment. 2. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. The form also indicated Patient 12 had a wound vacuum ordered. During a record review of Patient 12’s medical record form titled “Physician Order” dated 7/13/2024, indicated “SN to discontinue the wound vac treatment”. The form also indicated Patient 12 was ordered Santyl ointment as part of his wound treatment order. During a record review of Patient 12’s medical record form titled “Medication Profile” received from HHA on 7/16/2024 as requested, the form indicated Patient 12 was ordered Atorvastatin, Losartan, Metformin, and normal saline. During a concurrent observation, interview, and record review, at the home visit on 7/17/2024 at 1 p.m., Licensed Vocational Nurse 3 (LVN 3) reviewed the medications Patient 12 was taking. The following medications were not listed in Patient 12’s record titled, “Medication Profile”, printed on 7/16/2024: Santyl – ointment medication for wounds. Patient 12 stated his right foot wound vacuum was discontinued on 7/11/2024 and started using Santyl at that time. During an interview on 7/18/2024 at 10:28 a.m. with DPCS, DPCS stated patients plans of care are not amended or updated when there is a new or revised doctor order. DPCS stated they used supplemented physician orders. During a record review of facility’s policy and procedure titled “Care Planning Process” revised November 2021, indicated “Changes in the plan of care will be noted with the following documentation: assessment, plan of care with clinical outcome goals; care plan with specific services/actions to be taken; clinical notes; verbal orders. Clinicians will inform the patients physician or any changes that suggest a need to alter the plan of care. Changes must be written, dated, and signed by the professional making the changes. The organization shall provide the patient and caregiver with a copy of written instructions outlining: any treatment to be administered by the organization’s personnel and personnel acting on behalf of the organization, including therapy services.”

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to notify the physician of a change of condition for one of seventeen sampled patients (Patient 1). This failure resulted in missed opportunity to alter the plan of care to meet the needs of the patient. A record review of Patient 1’s “Patient Profile” indicated a start of care date on 5/4/2024, with a primary diagnosis of encounter for change or removal of surgical wound dressing. A record review of Patient 1’s “Home Health Certification and Plan of Care”, for certification period 7/3/2024 to 8/31/2024, indicated the skilled nurse was to continue the doctor if there were significant clinical findings. During a concurrent interview and record review on 7/19/2024, at 1:17 p.m., the Director of Patient Care Services (DPCS) reviewed Patient 1’s record titled, “LVN Wound Care Visit Note”, dated 7/8/2024. The DPCS stated the document did not indicate the doctor was notified of Patient 1 needing to go to the emergency room. During an interview on 7/19/2024, at 2:02 p.m., Licensed Vocational Nurse 3 (LVN 3) stated he visited Patient 1 on 7/8/2024 and instructed him to go to the emergency room (ER). LVN 3 stated the reason he instructed Patient 1 to go the ER was because LVN 3 was concerned, he had lost weight, looked dehydrated, and had not seen a doctor for over a month. LVN 3 stated he was not concerned about the wound. LVN 3 stated he did not notify any doctor because he was sure Patient 1 would go to the ER. During an interview on 7/19/2024, at 4:20 p.m., the DPCS stated LVN 3’s concerns about Patient 1 losing weight and looking dehydrated was considered a change of condition and should have been reported to the doctor. The DPCS stated the most important thing was coordination of care. The HHA needed to get a specific order on what needs to be done for the patient, to prevent re-hospitalization. During a record review of facility’s policy and procedure titled “Monitoring Patient’s Response/Reporting to Physician” revised November 2021, indicated “Clinicians will monitor, and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician will be contacted on the same day when any of the following occur: changes in the patient’s condition; when a visit is missed for any reason; All conferences or attempts to communicate with the physician will be documented in the clinical record.”

Revised plan of care CFR(s): 484.60(c)(2) A revised plan of care must reflect current information from the patient's updated comprehensive assessment, and contain information concerning the patient's progress toward the measurable outcomes and goals identified by the HHA and patient in the plan of care. This ELEMENT is not met as evidenced by: Based on interview, and record review, the HHA failed to ensure the plan of care reflected current information from the updated comprehensive assessment for one of seventeen sampled patients (Patient 4). This failure resulted in the patients not receiving the care as written in the plan of care. A record review of Patient 4’s “Patient Profile”, indicated a start of care on 6/13/2024, with a primary diagnosis of encounter for change or removal of nonsurgical wound dressing. A record review of Patient 4’s “Home Health Certification and Plan of Care”, dated 6/13/2024 to 8/11/2024, indicated the patient was to have Occupational Therapy (OT) and Physical Therapy (PT). During a concurrent interview and record review on 7/19/2024, at 11:25 a.m., the Director of Patient Care Services (DPCS) reviewed Patient 4’s record titled, “Occupational Therapy Evaluation and Plan of Care”, dated 7/15/2024. The DPCS stated the record indicated the OT visits were to occur twice a week for three weeks starting the week of 7/21/2024, with a re-evaluation on the 6th visit. The DPCS stated the POC did not have this information and needed to be updated to include it. During a concurrent interview and record review on 7/19/2024, at 11:28 p.m., the DPCS reviewed Patient 4’s record titled, “PT Initial Evaluation”, dated 6/18/2024. The DPCS stated the PT were to visit the patient twice a week for three weeks, then once a week for one week. The DPCS stated the POC did not have this information and needed to be updated to include it.

Communication with all physicians CFR(s): 484.60(d)(1) Assure communication with all physicians or allowed practitioners involved in the plan of care. This ELEMENT is not met as evidenced by: Based on interview and record review, the agency’s skilled nurse (SN) failed to notify the physician of the patient's intense pain during the home visit for one of seventeen sampled patients (Patient 9). This deficient practice has the potential to result in the delay of treatment to mitigate the patient's pain causing more discomfort affecting the patient's quality of life. Findings: During a review of Patient 9’s Patient Profile sheet indicated a start of care date of 7/9/2024, with diagnoses including unspecified open wound, left lower leg, and cellulitis (bacterial infection of the skin) of left and right lower limb. During a review of Patient 9's Home Health Certification and Plan of Care (POC) for the certification period starting from 7/9/2024 to 9/6/2024, included an order for the skilled nurse (SN) frequency of visits of three times a week for nine weeks, for skilled assessment and observation of all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate) every visit, perform wound care on left lower leg, and to assess pain for location, character, intensity using the scale of 1-10 with 10 as the most intense level. The POC further indicated for the SN to report to the physician if the patient experiences pain levels greater than 6/10 or if the pain significantly impacts the patient’s ability to perform normal activities. During a concurrent interview and record review on 7/19/2024, at 11:55 a.m., with the Director of Patient Care Services (DPCS), the DPCS reviewed Patient 9’s record titled “LVN (licensed vocational nurse) Wound Care Visit Note”, dated 7/11/2024. The DPCS stated Patient 9 had a pain level 7/10 – very intense pain on left lower leg, and the visiting nurse should have notified the physician. The DPCS stated and acknowledged there was no documented evidence Patient 9’s very intense pain level was reported to the physician which had the potential for patient needs go unmet. During a review of the agency’s policy and procedure titled, “Care Planning Process” revised November 2021, indicated all clinicians including the physician (or other authorized licensed independent practitioner) involved in the patient’s care, either directly or indirectly, will contribute to the plan of care. The plan of care will be based upon the physician’s (or other authorized licensed independent practitioner’s) orders and will encompass the equipment, supplies and services required to meet the patient’s needs. During a review of the agency’s policy and procedure titled, “Monitoring Patient’s Response/Reporting to Physician” revised November 2021, indicated clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. All conferences or attempts to communicate with the physician will be documented in the clinical record.

Required items in clinical record CFR(s): 484.110(a)(1) The patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This ELEMENT is not met as evidenced by: Based interview and record review the Home Health Agency (HHA) failed to ensure clinical records reflected the care provided for two of seventeen sample patients (Patient 12 and Patient 13). This failure had the potential to result in an incomplete clinical record. 1. During a review of Patient 12’s medical record form title “Home Health Certification and Plan of Care” dated from 6/25/2024 – 8/23/2024, indicated a start of care date of 6/25/2024 with principal diagnosis of “encounter for change or removal of surgical wound dressing”. During a record review of Patient 12’s medical record form titled “LVN Wound Vac Note” dated 7/9/2024, indicated it was signed by License Vocational Nurse 3 (LVN3) on 7/9/2024. During a record review of Patient 12’s medical record form titled “Task Details – LVN/LPN Visit” undated, indicated License Vocational Nurse 3 (LVN3) “submitted with signature” visit note for 7/9/2024 on 7/16/2024. During a record review of Patient 12’s medical record form titled “LVN Wound Vac Note” dated 7/11/2024, indicated it was signed by LVN3 on 7/11/2024. During a record review of Patient 12’s medical record form titled “Task Details – LVN/LPN Visit” undated, indicated LVN3 “submitted with signature” visit note for 7/11/2024 on 7/17/2024. During a concurrent interview and record review on 7/18/2024 at 12:30 p.m. with the Director of Patient Care Services (DPCS) of Patient 12’s Electronic Medical Record (EMR), DPCS stated License Vocational Nurse 3 (LVN3) documented Patient 12’s visits conducted on 7/9/2024 and 7/11/2024 on 7/17/2024. DPCS stated LVN3 documented Patient 12’s visits late. 2. During a review of Patient 13’s medical record form title “Home Health Certification and Plan of Care” dated from 6/15/2024 – 8/33/2024, indicated a start of care date of 4/16/2024 with principal diagnosis of “encounter for change or removal of nonsurgical wound dressing”. The form also indicated “SN Frequency: 1w9”. During a record review of Patient 13’s medical record form titled “LVN Wound Vac Note” dated 7/11/2024, indicated it was signed by LVN3 on 7/11/2024. During a record review of Patient 13’s medical record form titled “Task Details – LVN/LPN Visit” undated, indicated LVN3 “submitted with signature” visit note for 7/11/2024 on 7/17/2024. During a concurrent interview and record review on 7/18/2024 at 12:30 p.m. with the DPCS of Patient 13’s EMR, DPCS stated License Vocational Nurse 3 (LVN3) documented Patient 13’s visit conducted on 7/11/2024 on 7/17/2024. DPCS stated LVN3 documented Patient 13’s visits late. During an interview on 7/18/2024 at 10:59 a.m. with the HA’s EMR representative (EMRR), EMRR stated a patients “Activity Log” indicates the username of the person who created the document, if there were changes to the document and who made the changes, the dated, and times, and a brief description or action that was made. During an interview on 7/18/2024 at 12:30 p.m. with the DPCS, DPCS stated the vising nurses have five days to complete and upload their patient visit notes. DPCS stated notes should be uploaded into their EMR system to ensure there is updated patient information.

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey. Intake No.: 96979 Representing the California Department of Public Health: Surveyor #22303, Health Facilities Evaluator Nurse Surveyor #44186, Health Facilities Evaluator Nurse Surveyor #44916, Health Facilities Evaluator Nurse Total Sample-17 Home Visit-6 Active Patients- 1023 On 3/29/23 at 7 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 called in the presence of the agency’s Director of Patient Care Services (DPCS) and Registered Nurse 1 (RN 1) for the agency’s failure to review, reconcile, and maintain an accurate list of Patient 1's medications by failing to check Patient 1's medication during the licensed nurse's home visits as indicated in the plan of care. Patient 1 was exhibiting facial grimacing upon moving her body around while sitting in her wheelchair and described as aggravating pain on her back, left hip, bilateral legs and ankle. On 3/30/23 at 4:21 p.m., the DPCS and RN 1 submitted an acceptable U removal plan that included the following: 1. RN to perform OASIS E - Follow up to reevaluate patients current health status with focus on pain assessment. 2. Plan of Care to be amended according to current assessment to include pain goals and interventions. 3. Educate patient on non-pharmacological pain relief measures that included the following: periods of time out of motorized wheelchair (ex: lay in bed, transfer to couch), heat pad, distraction, relaxation, massage, and physical therapy (PT). 4. Follow up patient’s PCP visit on 03/31/2023 with primary physician and initial pain management visit on April 04, 2023 with the consultant physician. 5. A referral for MSW will be requested to assist patient with community resources 6. PT evaluation scheduled for 03/30/2023 to evaluate and provide an ongoing treatment plan. 7. Case Manager has been counseled one on one by the DPCS and Administrator. Case Manager retrained on job responsibilities with focus on proper interdisciplinary communication. Case Manager will be placed on a (30) day probation. At the completion of the 30 days, a random review of assigned patients will be conducted to identify areas of improvement. Case Manager will perform daily courtesy calls to follow up patients current health status and pain until the patient has established a pain management regime with the pain management clinic. The completion of daily courtesy calls will be monitored by the RN. Case Manager will retrieve all pertinent information from the Medpoint portal related to the care of the patient. All documents will be uploaded to the patients chart. Assigned nurses (licensed vocational nurse [LVN]/RN) will reconcile patients medication on every visit. Medications with less than 14 days supplies will be followed up with pharmacy for refill and/or MD office for new order. The RN will oversee the completion of medication reconciliation by the visiting nurse as well monitor need for medication refills. Case Manager will follow-up with MD offices after scheduled visits to verify any changes to patients' medication regime. 8. Skilled nurse will implement non-pharmacological pain relief measures such as a heat pad on the affected area(s), distraction, relaxation, and massaging the affected area. 9. Medications will be expedited by alternate home delivery pharmacy upon receipt of new/refill prescription(s) 10. For a patient's report of unrelieved pain, a PRN (as needed) nursing visit will be performed to assist the patient with non-pharmacological methods of pain relief as stated in bullet point above. The MD office will be contacted to request an order for pain medication. If unable to obtain an order for pain medication, the patient will be encouraged to go to urgent care/ER as ordered by MD. On 3/31/23, at 1:40 p.m., the survey team removed the IJ after verifying and confirming onsite that the agency implemented the IJ removal plan in the presence of the the DPCS and RN 1. On 3/30/23 at 2:36 p.m., a second IJ situation was called in the presence of the agency’s DPCS for the agency's failure to follow the physician's orders to change the Foley (a catheter to drain the urine) catheter monthly as indicated in the patient's plan of care which resulted in Patient 1 having to go to the general acute care hospital's emergency room to change the Foley catheter. On 3/31/23 at 12:25 p.m., the DPCS and RN 1 submitted an acceptable U removal plan that included the following: A. PATIENT #1 1. Foley Catheter last changed on 03/08/2023 in GACH 1 and next scheduled Foley catheter change will be April 06, 2023. Foley catheter care by the LVN (licensed vocational nurse) is scheduled weekly. Follow up Foley change plotted within current episode will be on or before May 05, 2023 with weekly catheter care until end of episode on May 24, 2023. OASIS (Outcome Assessment Information Set, a standardized data set that measures quality and outcomes) Follow-up visit completed by the RN on March 30, 2023 for reassessment of patients current health needs and to amend current plan of care. Courtesy calls to the patient have been conducted on a daily basis to confirm the patient's needs are being met. The RN and LVN will continue to educate the patient on signs/symptoms of infection as demonstrated in skilled visit notes and OASIS. During an urgent staff meeting, the entire Case Management team were reeducated on the importance of patient follow up especially in those with higher needs such as wounds, pain, drains and catheters. The previous Case Managers have been removed from the case and received one on one counseling on the necessity of proper care coordination. B. PATIENT #15 1. Foley Catheter last changed on 03/18/2023 by agency's LVN and next scheduled Foley change will be April 18, 2023. Foley Catheter care by LVN is scheduled weekly. The assigned Case Manager/Care Coordinator and visiting nurse have been counseled on the need to perform a courtesy visit (drive-by) for all patients when unable to reach a patient by phone. The visiting nurse has been verbally counseled on the importance of following MD orders to change the Foley Catheter at least every (30) days. The patient has been educated on the importance of having the Foley Catheter changed every (30) days to avoid possible infection. The assigned Case Manager, Care Coordinator and visiting nurse have all received verbal counseling on the necessity of proper care coordination. C. Plan of Action for all agency patients with Foley catheters: 1. The intake department will identify those patients referred with a Foley Catheter and use the “FOLEY CATHETER '' tag in Axxess tags and “FOLEY” in patient MR# to filter all patients accepted with a Foley Catheter. 2. The Intake Department will ask the referral source to verify the date of the last catheter change and specific type of Catheter (In-dwelling, External, Intermittent). 3. The field clinicians (RN) will perform head to toe assessment and document date of last Foley change, follow up skilled nurse will assess Foley Catheter and inform PCP of any reportable sign/symptoms of UTI, no urine return, leakage/soilage, foul smell, cloudy urine during all skilled visits. 4. Skilled Nurses will be required to accurately document the date of Foley Catheter change and any pertinent information related to current status of catheter, will educate patients on signs and symptoms of infection and methods to avoid UTI (proper hygiene, adequate hydration, proper care around insertion site), will be provided literature (step by step instructions) to provide to the patient on proper Foley Catheter care. 5. All Skilled Nurses will be required to participate in mandatory clinical competency with focus on Foley Catheter management. D. CASE MANAGEMENT: 1. The assigned Case Manager/Care Coordinator will run a morning report of all patients with Foley Catheters via Axxess EMR. 2. The assigned Case Manager/Care Coordinator will identify the last date of Foley change and ensure that 30 days has not elapsed since. 3. The assigned Case Manager will remind visiting nurses seven days prior to scheduled Foley change to ensure the patient is aware of scheduled Foley change and that the necessary supplies are available. The entire Case Management team will participate in weekly (Monday) Foley Catheter rounds to discuss all patients who presently have a Foley Catheter. 4. All incoming MD orders will be placed in the patient’s chart under the name of the assigned Clinical Manager. Clinical Manager will check all assigned orders on a daily basis to ensure that MD orders are carried out accordingly. 5. The agency will have an inservice presented by outside company on Foley Catheter care/management. 6. The RNs (field clinician) will oversee all aspects of care related to Foley Catheter care patients. On 3/31/23 at 4:46 p.m., the survey team removed the IJ after verifying and confirming onsite that the agency implemented the IJ removal plan in the presence of DPCS and RN 1. The following three Conditions of Participation (COP) were not met: 484.55- Comprehensive Assessment of Patients 484.60-Care planning, Coordination, Quality of care 484.75- Skilled Professional Services

Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient's eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the home health agency (HHA) failed to meet the Condition of Participations for Comprehensive Assessment of Patients, as follows: The home health agency failed to: 1. Conduct a comprehensive assessment (an examination of social and behavioral influences, health risks and information needs of patients and/or families/caregivers), for 1 of 17 sampled patients, (Patient 6). This deficient practice resulted in the delay of the care and services needed to maintain the highest practicable physical, mental and psychosocial well-being of Patient 6. (Refer to G514) 2. Review, reconcile, and maintain an accurate list and supplies of all the medications 5 of 17 sampled patients, (Patients 1, 7, 8, 9, and 12) are currently taking. For Patient 1, the skilled nurse failed to check the patient's medications during the home visits as indicated in the patient's plan of care. During the surveyor's home visit on 3/29/23, Patient 1's Baclofen (a medication used to treat muscle spasms) medication was observed empty and Patient 1 stated she ran out of Baclofen medication since 3/10/23. This failure resulted in Patient 1 was observed having facial grimacing when moving her body around while sitting in her wheelchair, had a pain scale (a tool that doctors use to help assess a person's pain, 0 means no pain; one to three means mild pain; four to seven is considered moderate pain; eight and above is severe pain) of 8 out of 10 (severe pain) aggravating pain in her back, left hip, bilateral legs, and ankles. This failure also placed the patients at risk of medication errors and adverse drug reactions that could affect the patient's already compromised health status. (Refer to G536) The cumulative effect of this systemic practice resulted in the agency failure to ensure they had a functioning organization administration of services. .

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to conduct a comprehensive assessment (an examination of social and behavioral influences, health risks and information needs of patients and/or families/caregivers), for 1 of 17 sampled patients, (Patient 6). This deficient practice resulted in the delay of the care and services needed to maintain the highest practicable physical, mental and psychosocial well-being of Patient 6. A complaint validation survey was conducted at this agency on 3/28/23 to 4/2/23. During a record review for Patient 6's form titled, "Home Health Certification and Plan of Care" (POC), with the certification period from 2/3/23 to 4/3/23, indicated a start of care (SOC) of 6/8/22. Diagnoses included paraplegia (paralysis of one side of the body) and an encounter for fitting and adjustment of urinary device (foley catheter, a flexible tube that a clinician passes through the urethra and into the bladder to drain urine). The record also indicated Patient 6 was recertified for foley catheter care and management and health teaching. Patient 6 was hypertensive and was unable to perform his own foley catheter care due to a lack of knowledge and the caregiver was not yet competent to assume full responsibility of Patient 6's care. Patient 6 continues to require skilled nursing visit once a week for nine weeks for observation and assessment of patient status, foley catheter care/management and monitoring for signs and symptoms of infection, health teachings, medication compliance/management and safety measures. A phone interview was conducted on 4/1/23 at 12:02 p.m. with Family Member 2 (FM 2). FM 2 stated Patient 6's foley catheter was removed two days ago prior to his doctor's appointment. FM 2 also stated that Registered Nurse 3 (RN) came on 3/31/23 and told her to take Patient 6 to the general acute care hospital (GACH) emergency room (ER) for a urinary tract infection (UTI). FM 2 stated that Patient 6 refused to go to the ER and performed self catheterization and felt better after that. A request was made to the Field Registered Nurse Supervisor (FRNS) on 4/1/23 at 12:00 noon for any communication notes and initial Outcome and Assessment Information Set (OASIS-instrument/data collection tool used to collect and report assessment data by home health agencies) and initial admission records for Patient 6. During a record review of the home health agency’s (HHA) document titled, "Communication Note" dated 3/31/23 at 3:12 p.m. electronically signed by Care Coordinator (CC) on 3/31/2023, indicated RN 3 mentioned Patient 6 seemed to have symptoms of a urinary tract infection and RN 3 advised the patient to go to the ER. Patient 6 did not have the foley in place, it was removed yesterday (3/30/2023). It also indicated, "Patient 6 is able to void and was sent the wrong supplies. Since patient will be going to the ER, RN will not do the recert and will wait for now. CC also wrote that patients family member (FM) stated patient did not have foley catheter since 3/29/23. Patient 6 does not want the catheter and does not want to follow up with his surgery. Per care coordinator when she asked the patient’s FM, the FM stated that patient does not have the catheter since 3/29/23). FM also stated Patient 6 started to not feel well and tried to convince the patient to go to the ER. A review of Patient 6's initial OASIS dated 3/31/20, did not indicate a written documentation in the narrative assessment that Patient 6 was able to perform self-catheterization. The plan of care for the certification period of 3/31/20 to 5/31/20 did not show written documentation that would indicate the patient was assessed for self-catheterization. Furthermore, the electronic medical record did not indicate a written physician’s orders that Patient 6 may perform self-catheterization when needed. During an interview with FRNS on 4/1/23 at 2:56 p.m., FRNS stated the field nurse should have read the admission documentation first before admission. FRNS also stated that the field staff should conduct proper head to toe assessments so they will have a better idea of the patients plan of care. Field staff should also educate patients every visit. When asked where the assessment was when the field RN stated the patient "Seem to have a UTI" and how did the field nurse ended up with that outcome, RNFS stated "She told me it was bladder spasms" when asked what kind of bladder spasms? was there pain, how bad was the pain? where is the pain assessment? RNFS could not provide any written documentation from the field nurse. RNFS stated "She did not perform her recertification assessment." A review of the HHA's policy titled " Initial and Comprehensive Assessment" CA Joint Commission Home Health /Revised 11/21, indicated during the initial and comprehensive assessment, all baseline data is to be used in measuring the patient's progress towards goals and other relevant information will be documented in the patient’s clinical record, including at least the following information, if applicable: a physical assessment, including blood pressure, temperature, pulse, respiration, skin, pain status, approximate height and weight, nutritional status and other relevant data related to pertinent physical findings. The patients’ medical and psychosocial history, including pertinent diagnoses and prognosis, patient's psychosocial status, including emotional barriers to treatment, the patient and family's educational needs, an evaluation of the home environment, evaluation of the emergency preparedness and review of medication history.

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 observation, interview and record review, the home health agency (HHA) failed to review, reconcile, and maintain an accurate list and supplies of all the medications 5 of 17 sampled patients, (Patients 1, 7, 8, 9, and 12) are currently taking. For Patient 1, the skilled nurse failed to check the patient's medications during the home visits as indicated in the patient's plan of care. During the surveyor's home visit on 3/29/23, Patient 1's Baclofen (a medication used to treat muscle spasms) medication was observed empty and Patient 1 stated she ran out of Baclofen medication since 3/10/23. This failure resulted in Patient 1 was observed having facial grimacing when moving her body around while sitting in her wheelchair, had a pain scale (a tool that doctors use to help assess a person's pain, 0 means no pain; one to three means mild pain; four to seven is considered moderate pain; eight and above is severe pain) of 8 out of 10 (severe pain) aggravating pain in her back, left hip, bilateral legs, and ankles. This failure also placed the patients at risk of medication errors and adverse drug reactions that could affect the patient's already compromised health status. On 3/29/23 at 7 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 called in the presence of the agency’s Director of Patient Care Services (DPCS) and Registered Nurse 1 (RN 1) for the agency’s failure to review, reconcile, and maintain an accurate list of Patient 1's medications by failing to check Patient 1's medication during the licensed nurse's home visits as indicated in the plan of care. Patient 1 was exhibiting facial grimacing upon moving her body around while sitting in her wheelchair and described as aggravating pain on her back, left hip, bilateral legs and ankle. On 3/30/23 at 4:21 p.m., the DPCS and RN 1 submitted an acceptable U removal plan that included the following: 1. RN to perform OASIS E - Follow up to reevaluate patients current health status with focus on pain assessment. 2. Plan of Care to be amended according to current assessment to include pain goals and interventions. 3. Educate patient on non-pharmacological pain relief measures that included the following: periods of time out of motorized wheelchair (ex: lay in bed, transfer to couch), heat pad, distraction, relaxation, massage, and physical therapy (PT). 4. Follow up patient’s PCP visit on 03/31/2023 with primary physician and initial pain management visit on April 04, 2023 with the consultant physician. 5. A referral for MSW will be requested to assist patient with community resources 6. PT evaluation scheduled for 03/30/2023 to evaluate and provide an ongoing treatment plan. 7. Case Manager has been counseled one on one by the DPCS and Administrator. Case Manager retrained on job responsibilities with focus on proper interdisciplinary communication. Case Manager will be placed on a (30) day probation. At the completion of the 30 days, a random review of assigned patients will be conducted to identify areas of improvement. Case Manager will perform daily courtesy calls to follow up patients current health status and pain until the patient has established a pain management regime with the pain management clinic. The completion of daily courtesy calls will be monitored by the RN. Case Manager will retrieve all pertinent information from the Medpoint portal related to the care of the patient. All documents will be uploaded to the patients chart. Assigned nurses (licensed vocational nurse [LVN]/RN) will reconcile patients medication on every visit. Medications with less than 14 days supplies will be followed up with pharmacy for refill and/or MD office for new order. The RN will oversee the completion of medication reconciliation by the visiting nurse as well monitor need for medication refills. Case Manager will follow-up with MD offices after scheduled visits to verify any changes to patients' medication regime. 8. Skilled nurse will implement non-pharmacological pain relief measures such as a heat pad on the affected area(s), distraction, relaxation, and massaging the affected area. 9. Medications will be expedited by alternate home delivery pharmacy upon receipt of new/refill prescription(s) 10. For a patient's report of unrelieved pain, a PRN (as needed) nursing visit will be performed to assist the patient with non-pharmacological methods of pain relief as stated in bullet point above. The MD office will be contacted to request an order for pain medication. If unable to obtain an order for pain medication, the patient will be encouraged to go to urgent care/ER as ordered by MD. On 3/31/23, at 1:40 p.m., the survey team removed the IJ after verifying and confirming onsite that the agency implemented the IJ removal plan in the presence of the the DPCS and RN 1. 5. A review of Patient 12's clinical record indicated a start of care (SOC) date of 1/17/2023 with a diagnosis that includes encounter for fitting and adjustment of urinary device, and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 12's Home Health Certification and Plan of Care (POC) for certification period from 3/18/2023 to 5/16/2023, included an order for the skilled nurse (SN) to visit once a week for 9 weeks, to instruct patient/caregiver on disease process, reportable signs/symptoms, complication and interventions, and compliance to prescribe medications, frequency, refills, and dosages. On 3/29/2023, at 9:50 a.m., a joint home visit with Licensed Vocational Nurse (LVN 1) was conducted at Patient 12’s residence. Patient 12 was observed awake, alert, and with some confusion. During a review of Patient 12’s current medication with the patient’s caregiver (Family member 1), it included a bottle of Amlodipine 2.5 milligram (mg) 1 tablet daily, Finasteride 5 mg 1 tablet daily and Tamsulosin 0.4 mg 1 capsule daily. Family member 1 stated Patient 12 have been taking these medications for the past several months. The medication profile provided by the HHA did not have these medications listed. On 4/01/2023, at 3:45 p.m., during an interview with the Director of Patient Care Services (DPCS), the DPCS stated patient’s medication profile should have been reconciled and updated on every SN visits. A review of the agency’s policy and procedure titled “Medication Profile,” revised November 2020, indicated patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. A complaint validation survey investigation was conducted on 3/28/23 through 4/2/23 at this agency. 2. A review of Patient 7’s document titled "Patient Profile", showed that Patient 7 is a 74 year old male admitted on 10/2/21 with the diagnosis of stage 2 pressure ulcer( usually a tender and painful shallow crater in the skin)with certification period from 3/26/23 to 5/24/23. The physician ordered to recertify SN visit four times a week for nine weeks for assessment, evaluation and observation of all bodily systems, vital signs every visit and record, pain for location, character, intensity using the scale of 1-10 (10 as the most intense level); nutrition/hydration status; skin integrity and condition; support system and home for safety, and potential hazards. SN to review medical regimen, patient/caregiver compliance, effectiveness of medications/orders and need to modify plan of treatment. A joint home visit was conducted at Patient 7's home on 3/29/23 at 11:15 a.m., with the Registered Field Nurse Supervisor (RNFS). Patient 7 was in the hospital bed inside the bedroom with wife at bedside. Patient 7 has stage 2 sacral ulcer and gastrostomy tube. Wife stated the licensed vocational nurse (LVN) came today and changed his dressings. RNFS proceeded with her visit. During the medication review with RNFS and Patient's daughter on the phone on the same date and time the following medications were not listed on the Patient 7's medication profile: Zinc sulfate 50 milligrams(mg-unit of measurement) 1 tablet daily as wound supplement Seroquel 50 mg 1 tablet as needed at bedtime for restlessness Olanzapine 2.5 mg 2 tabs twice daily for parkinsonism Loratadine 10 mg once daily for congestion Senna 8.5 mg 2 tablets daily as needed for constipation Vitamin D3 25micrograms(mcg-unit of measurement) daily for supplement Morphine sulfate IR 15 mg 1/2 tab 1 hour before wound care Triamcinolone 0.1% cream for redness on groin Nystatin powder as needed for groin redness Midodrine 10 mg three times daily daughter stated now changed to as needed Vitamin C 500 mg twice daily now changed to daily for supplement Tylenol PM 1 tablet as needed for pain but on med profile its regular tylenol 325 mg as needed for pain. Patient's daughter stated the nurse only asks her for any changes on her medications. 3. A review of Patient 8’s document titled "Patient Profile", showed that Patient 8 is a 59 year old female admitted on 3/1/23 with the diagnosis of chronic obstructive pulmonary disease( COPD- is a disease that damages the lungs in ways that make it hard to breathe) with acute exacerbation with the certification period from 3/1/23 to 4/29/23. The physician ordered skilled nursing (SN) visit once a week for nine weeks for assessment, evaluation and observation of all bodily systems, vital signs every visit and record. Focus assessment on signs and symptoms of COPD, weakness, pain for location, character, intensity using the scale of 1-10 (10 as the most intense level); nutrition/hydration status; skin integrity and condition; support system and home for safety, and potential hazards. A joint home visit was conducted at Patient 8's mobile trailer home on 3/29/23 at 10:15 a.m., with the Registered Nurse Field Supervisor (RNFS). Patient 8 was sitting in her living room area. Patient 8 is alert and oriented to name, place and time, on oxygen at 2.5 liters per minute via nasal cannula attached on an oxygen concentrator. RNFS proceeded with her visit. During a medication review with Patient 8 revealed the following medication discrepancies: Pregabalin 50 mg 1 tablet twice daily for seizures. On medication profile it was listed at 25 mg. Patient stated its been 50 mg. Prednisone 40 mg on med profile but patient stated she has not been taking it for 1 week baclofen 20 mg three times daily. patient stated she does not need to take it three times. Suboxone 8mg/2mg four times daily. Zofran 4 mg 1 tablet as needed for nausea Valium 5 mg as needed for anxiety Turmeric chewable daily for supplement garlic capsules daily for supplement Fish oil daily for supplement Hydroxyzine 100 mg for anxiety Buspar 30 mg 2 tablets twice daily for depression. Patient 8 verbally stated " I usually tell them what I take or they ask me If I have any new medications. I have a lot of medications and I don't want them going through my stuff all the time." 4. A review of Patient 9’s document titled "Patient Profile", showed that Patient 9 is an 86 year old female admitted on 3/23/23 with the diagnosis of type 2 diabetes (condition that happens because of a problem in the way the body regulates and uses sugar as a fuel)with indwelling foley catheter with the certification period from 3/23/23 to 5/21/23. The physician ordered skilled nursing (SN) visit once a week for nine weeks for assessment, evaluation and observation of all bodily systems, vital signs every visit and record. Focus assessment on signs and symptoms or complications of foley catheter, essential hypertension , type 2 diabetes with diabetic neuropathy, pain for location, character, intensity using the scale of 1-10 (10 as the most intense level); nutrition/hydration status; skin integrity and condition; support system and home for safety, and potential hazards. A phone interview was made with family member 3 (FM 3) on 4/1/23 at 12:30 p.m. During the medication phone review with FM 3 the following discrepancies were noted: Cholecalciferol 2000 units 1 tablet daily as supplement. FM 3 stated "the pharmacy had ran out of stock and she had to order online and this is what she had ordered." Insulin Glargine 20 units twice daily breakfast and dinner for diabetes. On med profile it was listed as daily. Insulin Lispro 7 units three times daily. On med profile it was before breakfast. Escitalopram 10 mg 1/4 tablet daily. On med profile it was 1/2 tablet daily. Tylenol 325 mg 1 tablet as needed for pain not listed on med profile. During an interview with the RNFS on 3/29/23 at 11:10 a.m., stated that the field staff would ask the patient or the family for any new or changes in the patients medications. RN checks medications only during recertification. A review of the HHA's policy titled "Administration and Documentation of Medications" CA Joint Commission Home health Revised 11/20, stipulated As part of the assessment process , a drug history will be taken and a comparison made between the physician's orders and the current medication the patient is taking. Any discrepancies or contradictions will be reported to the physician for resolution. 1. A review of Patient 1’s face sheet indicated the patient was admitted to the home health agency on 7/29/22, with diagnoses including hemiplegia (paralysis on one side of the body) and encounter for fitting and adjustment of urinary device. A review of Patient 1's Plan of Care (POC) dated from 1/25/23 to 3/25/23, included an order for the skilled nurse (SN) to visit once a week for 9 weeks, to instruct patient/caregiver on disease process, reportable signs/symptoms, complication and interventions, and compliance to prescribe medications, frequency, refills, and dosages. On 3/29/23, at 11 a.m., a home visit was conducted at Patient 1's residence with RN 1 (registered nurse). Patient 1 was observed sitting on her wheelchair having facial grimacing when moving her body around while sitting in her wheelchair. At 11:45 a.m., a review was conducted of Patient 1's current medications reconciling with the medication profile provided by the agency. It was observed Patient 1 had a bottle of Baclofen 10 mg one tab three times a day but was empty. When Patient 1 was asked when was the last time she took the Baclofen medication, she stated she ran out of baclofen medication since 3/10/23, and she have this constant , aggravating pain and she had no pain medication to relieve her pain. she also stated she has a pain scale of 8/10 at her back, left hip, bilateral legs and ankles. She further stated the visiting nurse does not check her medications when they visit and the agency was aware of her pain status but no one pays attention to her care. She further stated she could not stand the pain anymore and she will head to the emergency room today to help her out with her pain issue. A review of Patient 1’s LVN 1 "Communication Notes" dated 2/9/23 and 3/15/23 indicated that LVN 1 made a telephone call to Patient 1 but there was no answer to reach out for an appointment visit. However, there was no documented evidence LVN 1 made a second call and a drive-by at the patient’s residence on each date as per agency’s policy for missed visits. A review of RN document titled "Supervisory Visits" on 2/27/23 and 3/13/23, indicated there was certified home health assistant (CHHA) supervisory visits but there was no documented evidence that the visiting RN were checking the patient's medications and addressed the issue of the patient's Baclofen medication ran out and needed to be refilled to relieve her existing pain. On 3/30/23, at 1 p.m., during an interview with Case Manager 1, she stated she was the RN assigned to Patient 1. She also stated that she did a recertification visit on 3/24/23, but during her visit she did not check Patient 1's actual medication bottles one by one. A review of the agency’s policy and procedure titled “Medication Profile,” revised November 2020, indicated patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications.

Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient's medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This CONDITION is not met as evidenced by: Based on observation, interview and record review, the home health agency failed to ensure the physician orders or plan of care were implemented for four of 17 sampled patients (Patient 1, 6, 12, 15). The home health agency failed to: 1. Ensure Patient 1's Foley ( a thin, flexible tube placed in your bladder to drain your urine) catheter was changed once a month as per physician’s orders. This deficient practice resulted in Patient 1 ’s severe pain and urinary tract infection. ( Refer to G580) 2. Ensure Patient 6, had a physician's order for self-catheterization. This deficient practice placed the patient at risk for injury and urinary tract infections. (Refer to G 580) 3. Ensure the visiting nurse notified Patient 12’s physician promptly of an abnormal heart rate of 111 beats per minute (normal heart rate is within 60 to 100 beats per minute) per plan of care. This deficient practice placed Patient 6 at risk for heart complications. (Refer to G580) 4. Ensure the visiting nurse provided Patient 15, foley catheter (tube to drain urine) care every week as ordered by the physician. This deficient practice placed the patient at risk for urinary tract infections. (Refer G580). 5. Coordinate the care and services necessary to meet the individualized plan of care for one of nine sampled patients (Patient 8) for home visits. This deficient practice had the potential to result in delay in implementing Patient 8's plan of care. (Refer to G608). The cumulative effects of these systemic deficient practices resulted in the home health agency's failure to maintain and ensure the individualized plan of care was followed to reach patient goals and outcomes. .

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 observation, interview and record review, the home health agency failed to ensure the physician orders or plan of care were implemented for four of 17 sampled patients (Patient 1, 6, 12, 15). The home health agency failed to: 1. Ensure Patient 1's Foley ( a thin, flexible tube placed in your bladder to drain your urine) catheter was changed once a month as per physician’s orders. This deficient practice resulted in Patient 1 ’s severe pain and urinary tract infection. 2. Ensure Patient 6, had a physician's order for self-catheterization. This deficient practice placed the patient at risk for injury and urinary tract infections. 3. Ensure the visiting nurse notified Patient 12’s physician promptly of an abnormal heart rate of 111 beats per minute (normal heart rate is within 60 to 100 beats per minute) per plan of care. This deficient practice placed Patient 6 at risk for heart complications. 4. Ensure the visiting nurse provided Patient 15, foley catheter (tube to drain urine) care every week as ordered by the physician. This deficient practice placed the patient at risk for urinary tract infections. On 3/30/23 at 2:36 p.m., an IJ situation was called in the presence of the agency’s DPCS for the agency's failure to follow the physician's orders to change the Foley (a catheter to drain the urine) catheter monthly as indicated in the patient's plan of care which resulted in Patient 1 having to go to the general acute care hospital's emergency room to change the Foley catheter. On 3/31/23 at 12:25 p.m., the DPCS and RN 1 submitted an acceptable U removal plan that included the following: A. PATIENT #1 1. Foley Catheter last changed on 03/08/2023 in GACH 1 and next scheduled Foley catheter change will be April 06, 2023. Foley catheter care by the LVN (licensed vocational nurse) is scheduled weekly. Follow up Foley change plotted within current episode will be on or before May 05, 2023 with weekly catheter care until end of episode on May 24, 2023. OASIS (Outcome Assessment Information Set, a standardized data set that measures quality and outcomes) Follow-up visit completed by the RN on March 30, 2023 for reassessment of patients current health needs and to amend current plan of care. Courtesy calls to the patient have been conducted on a daily basis to confirm the patient's needs are being met. The RN and LVN will continue to educate the patient on signs/symptoms of infection as demonstrated in skilled visit notes and OASIS. During an urgent staff meeting, the entire Case Management team were reeducated on the importance of patient follow up especially in those with higher needs such as wounds, pain, drains and catheters. The previous Case Managers have been removed from the case and received one on one counseling on the necessity of proper care coordination. B. PATIENT #15 1. Foley Catheter last changed on 03/18/2023 by agency's LVN and next scheduled Foley change will be April 18, 2023. Foley Catheter care by LVN is scheduled weekly. The assigned Case Manager/Care Coordinator and visiting nurse have been counseled on the need to perform a courtesy visit (drive-by) for all patients when unable to reach a patient by phone. The visiting nurse has been verbally counseled on the importance of following MD orders to change the Foley Catheter at least every (30) days. The patient has been educated on the importance of having the Foley Catheter changed every (30) days to avoid possible infection. The assigned Case Manager, Care Coordinator and visiting nurse have all received verbal counseling on the necessity of proper care coordination. C. Plan of Action for all agency patients with Foley catheters: 1. The intake department will identify those patients referred with a Foley Catheter and use the “FOLEY CATHETER '' tag in Axxess tags and “FOLEY” in patient MR# to filter all patients accepted with a Foley Catheter. 2. The Intake Department will ask the referral source to verify the date of the last catheter change and specific type of Catheter (In-dwelling, External, Intermittent). 3. The field clinicians (RN) will perform head to toe assessment and document date of last Foley change, follow up skilled nurse will assess Foley Catheter and inform PCP of any reportable sign/symptoms of UTI, no urine return, leakage/soilage, foul smell, cloudy urine during all skilled visits. 4. Skilled Nurses will be required to accurately document the date of Foley Catheter change and any pertinent information related to current status of catheter, will educate patients on signs and symptoms of infection and methods to avoid UTI (proper hygiene, adequate hydration, proper care around insertion site), will be provided literature (step by step instructions) to provide to the patient on proper Foley Catheter care. 5. All Skilled Nurses will be required to participate in mandatory clinical competency with focus on Foley Catheter management. D. CASE MANAGEMENT: 1. The assigned Case Manager/Care Coordinator will run a morning report of all patients with Foley Catheters via Axxess EMR. 2. The assigned Case Manager/Care Coordinator will identify the last date of Foley change and ensure that 30 days has not elapsed since. 3. The assigned Case Manager will remind visiting nurses seven days prior to scheduled Foley change to ensure the patient is aware of scheduled Foley change and that the necessary supplies are available. The entire Case Management team will participate in weekly (Monday) Foley Catheter rounds to discuss all patients who presently have a Foley Catheter. 4. All incoming MD orders will be placed in the patient’s chart under the name of the assigned Clinical Manager. Clinical Manager will check all assigned orders on a daily basis to ensure that MD orders are carried out accordingly. 5. The agency will have an inservice presented by outside company on Foley Catheter care/management. 6. The RNs (field clinician) will oversee all aspects of care related to Foley Catheter care patients. On 3/31/23 at 4:46 p.m., the survey team removed the IJ after verifying and confirming onsite that the agency implemented the IJ removal plan in the presence of DPCS and RN 1. 1. A review of Patient 1’s face sheet indicated the patient was admitted to the home health agency on 7/29/22, with diagnoses including hemiplegia (paralysis on one side of the body) and encounter for fitting and adjustment of urinary device. A review of Patient 1's Plan of Care (POC) dated from 1/25/23 to 3/25/23, included an order for the skilled nurse (SN) to visit once a week for 9 weeks, to perform foley (is a thin, flexible tube placed in your bladder to drain your urine (pee) and care once a month to assess foley catheter 16 french (Fr- size of the foley catheter) for placement and patency, site for signs and symptoms of infection, to change 16Fr foley catheter every month or as needed using a sterile technique. The patient is chairbound. On 3/24/23, at 3:15 p.m., during an interview with the Director of Patient Care Services (DPCS), she stated Patient 1 strictly requested that Licensed Vocational Nurse 1 (LVN 1) would be the only nurse to change her foley catheter. The DPCS also stated that Patient 1’s foley catheter was last changed on 12/30/22. She further stated that Patient 1’s foley catheter has not been changed by LVN 1 since 12/30/22 to 3/7/23, in which there was a communication note on 3/10/23 that indicated that Patient 1 told Registered Nurse 1 (RN 1) that she went by herself to hospital’s emergency room on 3/8/23, to have her foley catheter changed because she had urinary tract infection (UTI). A review of Patient 1’s LVN 1 "Communication Notes" dated 1/23,1/26/23, 2/2, 2/7, 2/9 and 3/15/23 indicated that LVN 1 made a telephone call to Patient 1 but there was no answer to reach out for an appointment visit. However, there was no documented evidence LVN 1 made a second call and a drive-by at the patient’s residence on each date as per agency’s policy for missed visits. On 3/24/23, at 4 p.m., during an interview with the DPCS, she stated LVN 1 should try to make a second call and a drive-by on the same day when he could not reach Patient 1 during his first attempt phone call for scheduling an appointment. A review of RN document titled "Supervisory Visits" on 1/24/23, 2/7, 2/22, 2/27/23 and 3/13/23, indicated there was certified home health assistant (CHHA) supervisory visits but there was no documented evidence that RN 1 addressed the issue if the patient 1's foley was changed and an assessment of urine characteristics upon the above mentioned visit dates. 2. Patient 6's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), with the certification period from 2/3/23 to 4/3/23, indicated the start of care (SOC) of 6/8/22, with diagnoses of paraplegia (paralysis of one side of the body) and encounter for fitting and adjustment of urinary device (foley catheter- is a flexible tube that a clinician passes through the urethra and into the bladder to drain urine. It is the most common type of indwelling urinary catheter). Patient 6 is a 24 year old male recertified for foley catheter care and management and health teaching. Patient 6 is hypertensive and is unable to do own foley catheter due to lack of knowledge and caregiver is not yet competent to assume full responsibility of patient's care. Patient 6 continues to require skilled nursing visit once a week for nine weeks for observation and assessment of patient current status, foley catheter care/management and monitoring for signs and symptoms of infection, health teachings, medication compliance/management and safety measures. SN to continue to notify MD for severe weakness/fatigue, dyspnea/shortness of breath, signs and symptoms of congestion; output of less than 30 ml/hr.; inability to defecate after 3 days; systolic blood pressure greater than 160mmhg and less than 110 or diastolic blood pressure greater than 90 and less than 70mmhg, pain greater than 6/10 not relieved by rest or current medications and other significant clinical findings. A review of Patient 6's initial OASIS dated 3/31/20 indicated no written documentation in the narrative assessment for Patient 6 is able to perform self-catheterization and the plan of care for the certification period of 3/31/20 to 5/31/20 did not show written indication that the patient was assessed for self-catheterization. Furthermore, the electronic medical record showed no written physicians orders that patient 6 may perform self-catheterization when needed. During an interview with RNFS on 4/1/23 at 2:56 p.m., RNFS stated that the field nurse should have read the admission documentation first before admission. RNFS also stated that the field staff should conduct proper head to toe assessments and they would have a better idea of the patients plan of care. Field staff should also educate patients every visit. A review of the HHA's "LVN Catheter Note" on 3/2/23 LVN documented a pulse rate of 110 beats per minute(bpm), on 3/08/23 showed a pulse rate of 108 bpm, 2/23/23 of 120 bpm and on 3/23/23 showed that the patient had heart rate of 130 beats per minute. There was no documentation that the SN notified the physician for the times there was an increase in pulse rate. A phone interview was conducted on 4/1/23 with family member 2 (FM 2), FM 2 stated that Patient 6's foley catheter was removed 2 days ago prior to their doctor's appointment. Per FM 2 registered nurse 3 (RN 3) came on 3/31/23 and told her to bring the patient to the emergency room (ER) for urinary tract infection(UTI). FM 2 confirmed that the patient refused to go to the ER and performed self catheterization and was able to feel better after that. A request was made to the Registered Nurse Field Supervisor (RNFS) on 4/1/23 at 12:00 noon for any communication notes and initial Outcome and Assessment Information Set (OASIS-instrument/data collection tool used to collect and report assessment data by home health agencies) and initial admission records regarding Patient 6. On record review of the HHA's document titled "Communication Note" at the same date and time, showed that 3/31/23 RN 3 visited Patient 6 at 3:12 p.m. for a recertification visit. Per RN 3 stated that Patient 6 seem to have symptoms of urinary tract infection and advised the patient to go to the ER, patient did not have the foley on, it was removed yesterday. patient is able to void." RN 3 also stated that patient was sent the wrong supplies . Since patient will be going to the ER , RN will not do the recert and will wait for now." Care coordinator also wrote that patients mom stated that patient did not have foley catheter since 3/29/23, and does not want the catheter and does not want to follow up with his surgery. A review of Patient 6's initial OASIS dated 3/31/20 indicated no written documentation in the narrative assessment for Patient 6 is able to perform self-catheterization and the plan of care for the certification period of 3/31/20 to 5/31/20 did not show written indication that the patient was assessed for self-catheterization. Furthermore, the electronic medical record showed no written physicians orders that patient 6 may perform self-catheterization when needed. A review of the HHA's policy titled " Monitoring Patient's Response/Reporting To Physician" CA Joint Commission Home health/Revised 11/21 stipulated clinicians will monitor, document and report patient's response to care and treatment provided on each home visit. Progress towards goals will be be measured at regular intervals. Clinicians will establish establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. A review of the HHA's policy titled " Verification of Physicians Orders" CA Joint Commission Home health/Revised 11/20 indicated to ensure that accurate physician orders and prescriptions are obtained in accordance with state and federal law regulation. Orders will be obtained from a licensed physician for care and services to be provided to home health patients. 3. A review of Patient 15’s document titled " Home Health Certification and Plan of Care" indicated the patient was admitted to the home health agency on 1/24/23, with diagnoses including retention of urine unspecified and encounter for fitting and adjustment of urinary device with the certification period reviewed dated from 1/25/23 to 3/25/23, included an order for the SN to visit twice a week for one week and once a week for 8 weeks to perform foley care once a month to assess foley catheter 16 French (Fr- size of the foley catheter) for placement and patency, site for signs and symptoms of infection, to change 16Fr foley catheter every month or as needed using a sterile technique for leakage/malfunction unless otherwise MD requested to change in the MD's office. Instruct on complications or signs and symptoms of catheter associated urinary infections such as cloudy urine, blood in the urine, strong urine odor, urine leakage around catheter, pressure, pain , or discomfort in the lower back or stomach, chills, fever. A review of the HHA's document titled "LVN Catheter Care Note" dated 3/12/23 and 3/17/23 showed that LVN 3 documented the patient electronic medical record, indicated that the last catheter change on his noted were 1/27/23. A review of the HHA's document titled "Missed Visit" dated 2/8/23 indicated that there was no answer when the agency tried to conduct an LVN Catheter Care visit. Another "Missed visit" note was made on 2/14/23 when the agency tried to make an "LVN Catheter Care Visit" but there was no reason indicated by the LVN of the call. A review of the HHA's document titled "Physician's Orders" dated 2/20/23 signed by the Administrator/Registered Nurse(Admin/RN) on 2/20/23 at 12:05 p.m., indicated the agency asked the physician to "hold nursing visits from 2/19/23 to 2/26/23 patients nurse will be on leave and patient does not want any other nurse but her nurse Hugo". There was no written documentation on patient 15's chart that the patient was educated on the outcome of no nurse visits and the possibility of infection for no catheter change as ordered. A review of the home health agency's policy titled "Missed Visits,” indicated if a missed visit is missed for any reason, the clinician should attempt to reschedule it for the same week so that the physician ordered frequency is maintained and would not be considered a missed visit. The home health agency failed to ensure that their licensed nurse provided foley care every week and foley catheter change every month as ordered for a duration of 2 ½ months. As a result, the patient had UTI and she had to go ER to have her foley catheter changed. A review of Patient 1’s face sheet indicated the patient was admitted to the home health agency on 7/29/22, with diagnoses including hemiplegia (paralysis on one side of the body) and encounter for fitting and adjustment of urinary device. A review of Patient 1's Plan of Care (POC) dated from 1/25/23 to 3/25/23, included an order for the skilled nurse (SN) to visit once a week for 9 weeks, to instruct patient/caregiver on disease process, reportable signs/symptoms, complication and interventions, and compliance to prescribe medications, frequency, refills, and dosages. One of the SN intervention was to administer Baclofen 10 mg (milligrams) one tab three times daily. On 3/29/23, at 11 a.m., a home visit was conducted at Patient 1's residence with RN 1 (registered nurse). Patient 1 was observed sitting on her wheelchair having facial grimacing when moving her body around while sitting in her wheelchair. At 11:45 a.m., a review was conducted of Patient 1's current medications reconciling with the medication profile provided by the agency. It was observed Patient 1 had a bottle of Baclofen 10 mg one tab three times a day but was empty. When Patient 1 was asked when was the last time she took the Baclofen medication, she stated she ran out of baclofen medication since 3/10/23, and she have this constant , aggravating pain and she had no pain medication to relieve her pain. she also stated she has a pain scale of 8/10 at her back, left hip, bilateral legs and ankles. She further stated the visiting nurse does not check her medications when they visit and the agency was aware of her pain status but no one pays attention to her care. She further stated she could not stand the pain anymore and she will head to the emergency room today to help her out with her pain issue. A review of Patient 1’s LVN 1 "Communication Notes" dated 2/9/23 and 3/15/23 indicated that LVN 1 made a telephone call to Patient 1 but there was no answer to reach out for an appointment visit. However, there was no documented evidence LVN 1 made a second call and a drive-by at the patient’s residence on each date as per agency’s policy for missed visits. A review of RN document titled "Supervisory Visits" on 2/27/23 and 3/13/23, indicated there was certified home health assistant (CHHA) supervisory visits but there was no documented evidence that the visiting RN were checking the patient's medications and addressed the issue of the patient's Baclofen medication ran out and needed to be refilled to relieve her existing pain. On 3/30/23, at 1 p.m., during an interview with Case Manager 1, she stated she was the RN assigned to Patient 1. She also stated that she did a recertification visit on 3/24/23, but during her visit she did not check Patient 1's actual medication bottles one by one. On 4/3/23, at 12 p.m., during an interview with the DPCS, she stated the visiting nurse did not check Patient 1's medications during their visits, as a result, the patient's Baclofen medication ran out and she failed to take it for a week and half as ordered. A review of the agency’s policy and procedure titled “Medication Profile,” revised November 2020, indicated patients receiving medications will have a current, accurate medication profile in the clinical record. Medication profiles will be updated for each change to reflect current medications and new and/or discontinued medications. 3. A review of Patient 12's clinical record indicated a start of care (SOC) date of 1/17/2023 with a diagnosis that includes encounter for fitting and adjustment of urinary device, and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 12's Home Health Certification and Plan of Care (POC) for certification period from 3/18/2023 to 5/16/2023, included an order for the skilled nurse (SN) to visit once a week for 9 weeks to perform skilled assessment of all body systems, vital signs every visit and record. The POC also included an order for the SN to notify the physician if the systolic blood pressure (the first number, measures the pressure in your arteries when your heart beats) was greater than 160 mmHg and less than 100 mmHg (millimeter of mercury, a unit of pressure) or the diastolic blood pressure (the second number, measures the pressure in your arteries when your heart rests between beats) was greater than 90 mmHg and less than 60 mmHg, pain greater than 6/10 (on a pain scale 0/10, zero being no pain and 10 being the worst possible pain) not relieved by rest or current medications and other significant clinical findings. A review of the Licensed Vocational Nurse (LVN) Medication Teaching Visit Note dated 3/23/2023, indicated Patient 12’s pulse rate was 111 beats per minute(bpm). However, there was no documented evidence the physician was notified regarding the patient's high pulse rate. On 4/01/2023, at 3:45 p.m., during an interview and joint record review with the Director of Patient Care Services (DPCS), the DPCS was unable to provide documented evidence that the agency SN notified the physician regarding Patient 12’s high pulse rate. The DPCS stated the patient’s high pulse rate was a significant clinical finding and the agency’s field nurse should have notified the RN clinical manager or notified patient’s physician for further instruction. A review of the agency’s policy and procedure titled “Monitoring Patient’s Response/Reporting to Physician,” revised November 2021, indicated clinicians will monitor, document, and report the patient’s response to care and treatment provided on each home visit. Clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient.

Promptly alert relevant physician of changes CFR(s): 484.60(c)(1) The HHA must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient's condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered. This ELEMENT is not met as evidenced by: Based on interview and record review, Case Manager 1 failed to notify the physician promptly when one out of 17 sample patients (1) had an existing aggravating pain as a result from running out of Baclofen medication. This deficient practice placed the patients at a potential risk for complications that could affect their overall health status. A review of Patient 1’s face sheet indicated Patient 1 was admitted to the Home Health Agency on 7/29/22, with diagnoses that included hemiplegia (paralysis on one side of the body) and encounter for fitting and adjustment of urinary device. A review of Patient 1's Plan of Care (POC) dated from 1/25/23 to 3/25/23, included an order for the skilled nurse (SN) to visit Patient 1 once a week for nine weeks, to instruct patient/caregiver on disease process, reportable signs/symptoms, complication and interventions, and compliance to prescribe medications, frequency, refills, and dosages. On 3/29/23, at 11 a.m., a home visit was conducted at Patient 1's residence with RN 1 (registered nurse). Patient 1 was observed sitting in her wheelchair and had facial grimacing when moving her body around while sitting in her wheelchair. At 11:45 a.m., a review was conducted of Patient 1's current medications reconciling with the medication profile provided by the agency. It was observed Patient 1 had a bottle of Baclofen 10 mg one tab three times a day but was empty. When Patient 1 was asked when was the last time she took the baclofen medication, she stated she ran out of baclofen medication on 3/10/23, and she has constant aggravating pain and she had no pain medication to relieve her pain. She also stated her pain level was an 8/10 on a pain scale of 1/10 (eight being severe) to her back, left hip, bilateral legs and ankles. She further stated she called Case Manager 1 over the phone on 3/10/23 and made her aware she was in aggravating pain and her baclofen medication had run out. On 3/30/23, at 1 p.m., during an interview with Case Manager 1, she stated she talked to Patient 1 over the phone on 3/10/23, and she was aware the patient was in pain and did not have any pain medication. She also stated that she did not notify the physician about the patient's existing pain and she ran out of her pain medication. A review of Patient 1's Communication Note dated 3/10/23, indicated there was no documented evidence Case Manager 1 notified the physician regarding Patient 1's existing pain and that her pain medication run out. On 4/3/23, at 11 a.m., during an interview with the DPCS (Director of Patient Care Services), she stated Case Manager 1 should have notified the physician regarding the patient's existing pain promptly. A review of the agency's (undated) policy titled "Change of Condition" indicated the clinician is responsible for any specific treatment the nurse should notify the attending physician of significant changes in the patient's condition.

Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient's needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to coordinate care and services to meet the individualized plan of care for one of nine sampled home visit patients ( Patient 8) This deficient practice had the potential to result in a delay in implementing Patient 8's plan of care. A complaint validation survey investigation was conducted on 3/28/23 through 4/2/23 at this agency. A review of Patient 8’s document titled "Patient Profile," showed that Patient 8 was admitted to the agency on 3/1/23 with the diagnosis of chronic obstructive pulmonary disease( COPD- is a disease that damages the lungs in ways that make it hard to breathe) with acute exacerbation with a certification period of 3/1/23 to 4/29/23. The physician ordered skilled nursing (SN) to visit Patient 8 once a week for nine weeks for assessment, evaluation and observation of all bodily systems, vital signs every visit and record. Focus assessment on signs and symptoms of COPD, weakness, pain for location, character, intensity using the scale of 1-10 (10 as the most intense level); nutrition/hydration status; skin integrity and condition; support system and home for safety, and potential hazards. A home visit was conducted at Patient 8's mobile trailer home on 3/29/23 at 10:15 a.m., with the Registered Nurse Field Supervisor (RNFS). Patient 8 was sitting in her living room area. Patient 8 was alert and oriented to name, place and time, with oxygen infusing at 2.5 liters per minute via a nasal cannula attached via an oxygen concentrator. RNFS proceeded with her visit. During an interview with Patient 8 at the same date and time, Patient 8 mentioned that she was also under the care of a Palliative care agency who also sends a nurse to visit her at least twice a month. Patient 8 also mentioned that there was a power outage the last two weeks and she called the Palliative Care Agency instead of the Home health agency. When was asked why, Patient 8 stated, because "They were more closer to my location. They helped me when I lost power and when I burnt food on the microwave, smoke was everywhere and they were here to help me". During an interview with RNFS on 4/1/23 at 11:30 a.m., RNFS stated the agency knows that the patient is on Palliative care. On concurrent record review, the agency was unable to provide written documentation of the care coordination with the Palliative Care Agency. RNFS further mentioned the importance of coordinating with other agencies to provide the quality of care for the patient. A review of the HHA's policy titled " Care Planning Process" CA Joint Commission Home Health/revised November 2021, stipulated that all clinicians including the physician involved in the patients care, either directly or indirectly, will contribute to the plan of care whenever possible. The care planning process will be documented on the plan of care, individualized discipline specific care plans, clinical notes, medication profiles, care conference/summary forms, and discharge /clinical summaries.

Patients receive education and training CFR(s): 484.60(d)(5) Ensure that each patient, and his or her caregiver(s) where applicable, receive ongoing education and training provided by the HHA, as appropriate, regarding the care and services identified in the plan of care. The HHA must provide training, as necessary, to ensure a timely discharge. This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure the nursing staff provided instructions or health teaching to the patient's caregiver (PCG) and verified if Patient 6 was able to perform proper self-catheterization. This deficient practice has the potential to place the patient at risk for injury and urinary tract infection. A complaint validation survey was conducted at this agency on 3/28/23 to 4/2/23. Patient 6's record was reviewed. The forms titled, "Home Health Certification and Plan of Care" (POC), with the certification period of 2/3/23 to 4/3/23, indicated the start of care (SOC) date of 6/8/22, with diagnoses of paraplegia (paralysis of one side of the body) and encounter for fitting and adjustment of urinary device (Foley catheter- is a flexible tube that a clinician passes through the urethra and into the bladder to drain urine. It is the most common type of indwelling urinary catheter). Patient 6 was recertified for Foley catheter care and management and health teaching. Patient 6 was hypertensive and was unable to perform own Foley catheter care due to a lack of knowledge. The caregiver was not yet competent to assume full responsibility of Patient 6's care. Patient 6 continued to require skilled nursing visits once a week for nine weeks for observation and assessment of patient current status, Foley catheter care/management and monitoring for signs and symptoms of infection, health teachings, medication compliance/management and safety measures. A phone interview was conducted on 4/1/23, with Family Member 2 (FM 2), FM 2 stated Patient 6's Foley catheter was removed two days ago prior to their doctor's appointment. Per FM 2, Registered Nurse 3 (RN 3) came on 3/31/23 and told her to bring Patient 6 to the emergency room (ER) for a urinary tract infection(UTI). FM 2 confirmed that Patient 6 refused to go to the ER and performed self-catheterization and was able to feel better after that. A request was made to the Registered Nurse Field Supervisor (RNFS) on 4/1/23 at 12:00 noon for any communication notes and initial Outcome and Assessment Information Set (OASIS-instrument/data collection tool used to collect and report assessment data by home health agencies) and initial admission records regarding Patient 6. On record review of the HHA's document titled "Communication Note" at the same date and time, indicated that on 3/31/23 RN 3 had visited Patient 6 at 3:12 p.m. for a recertification visit. RN 3 stated Patient 6 seemed to have symptoms of an urinary tract infection and RN 3 advised Patient 6 to go to the ER,. She further stated Patient 6 did not have a Foley in place. It was removed yesterday and Patient 6 was able to void." RN 3 also stated that Patient 6 was sent the wrong supplies. Since Patient 6 would be going to the ER, the RN would not conduct the recert and would wait for now." The Care coordinator also wrote the patients mom stated Patient 6 has not had a Foley catheter since 3/29/23, does not want the catheter and does not want to follow up with his surgery. A review of Patient 6's initial OASIS dated 3/31/20 indicated there was no written documentation in the narrative assessment for Patient 6 to be able to perform self-catheterization. The plan of care for the certification period of 3/31/20 to 5/31/20 did not show written indication that Patient 6 was assessed for self-catheterization. Furthermore, the electronic medical record showed no written physicians orders that patient 6 may perform self-catheterization when needed. During an interview with RNFS on 4/1/23 at 2:56 p.m., RNFS stated the field nurse should have read the admission documentation first before admission. RNFS also stated the field staff should conduct proper head to toe assessments to have a better idea of the patients plan of care. Field staff should also educate patients every visit. A review of the HHA's policy C-200 titled "Skilled Nursing Services" Briggs Healthcare, indicated skilled nursing activities in the home care setting may include observation and assessment, teaching and training activities, management and evaluation of the care plan and routine and complex skilled procedures. Addendum to Operational Policies C-200 effective 3/30/23 indicated only persons (nursing staff, family members or patients themselves) who knows the correct technique of aseptic insertion and maintenance of the catheter should handle catheters. Nursing personnel will be given periodic education and training, stressing the correct techniques and potential complications of urinary catheterizations. A review of the HHA's policy titled "Patient Education Process" CA Joint Commission/Revised 11/20 stipulated, the clinician will assess, plan, implement and evaluate the pertinent information needed by the patient and family caregiver in relation to the care rendered on each patient and family/caregiver as appropriate.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to ensure home visits were conducted according to the plan of care (POC) for one of 17 sampled patients (Patient 15). This failure had the potential to result in the needs of patients to go unmet. Findings: A review of Patient 15's clinical record indicated a start of care (SOC) date of 1/24/2023 with a diagnosis that included encounter for fitting and adjustment of urinary device, and Down syndrome (a genetic chromosome 21 disorder causing developmental and intellectual delays). A review of Patient 15's Home Health Certification and Plan of Care (POC) for the certification period from 1/24/2023 to 3/24/2023, included an order for the skilled nurse (SN) to visit Patient 15 twice a week for one week and once a week for eight weeks, to perform a skilled assessment and observation of all body systems, vital signs every visit, and record. A review of Patient’s 15 clinical records indicated there was a missed visit note dated 1/31/2023 and 2/08/2023, and under the section “Reason” for missed visit, it indicated “No answer to phone call." A missed visit note dated 2/14/2023, under the section “Reason” and “Comment," it indicated it was blank. There was no documented evidence a second call was made, or that the agency attempted to reschedule the visit on the same week that there was a missed visit. On 4/1/2023, at 3:45 p.m., during an interview and joint record review with the Director of Patient Care Services (DPCS), the DPCS stated if the patient or family cannot be reached for scheduling a visit, the HHA should continue to make several follow-up calls all through out the week to reschedule a visit and/or to do a courtesy (drive-by) visit at the patient’s residence. The DPCS stated in this case, it was not done. A review of the agency’s policy and procedure titled “Missed Visits,” effective date 1/28/2022, indicated if a visit is missed for any reason, the clinician should attempt to reschedule it for the same week so that the physician ordered frequency is maintained and would not be considered a missed visit. If a visit is missed and not rescheduled, the missed visit report should contain the following information: 1. Date and type of visit that was missed 2. Reason for the missed visit 3. Description of any unmet needs and how the patient’s needs were met 4. Other person(s) who were notified of the missed visit 5. Any other follow-up needed 6. Signature of staff member reporting the information

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency (HHA) nursing staff failed to assess the pain level (intensity) as indicated in the plan of care, for two of 17 sampled patients (Patients 12 and 13). This deficient practice had the potential to result in a lack of detection of unrelieved pain and can affect the patient’s physical well-being. Findings: a. A review of Patient 12's clinical record indicated a start of care (SOC) date of 1/17/2023, with a diagnosis that included encounter for fitting and adjustment of urinary device, and epilepsy (a disorder in which nerve cell activity in the brain is disturbed, causing seizures). A review of Patient 12's Home Health Certification and Plan of Care (POC) for certification period from 1/17/2023 to 3/17/2023, included an order for the skilled nurse (SN) to visit Patient 12 one time for week 1 for evaluation only, physical therapist (PT) to visit two times a week for three weeks and one time for one week, and occupational therapist (OT) to visit two times a week for three weeks and one time for one week. A follow-up physician order with an effective date of 1/28/2023 indicated a frequency change for SN visit frequency to once a week for eight weeks. The POC included an order for the SN to perform a comprehensive skilled nursing assessment, observation and evaluation of all body systems, vital signs every visit, and focus assessment on pain for location, character, intensity using the scale of 1-10 (10 as the most intense level). On 3/29/2023, at 9:50 a.m., a joint home visit with Licensed Vocational Nurse (LVN 1) was conducted at Patient 12’s residence. Patient 12 was observed awake, alert, and with some confusion. Patient 12’s caregiver (Family member 1) stated Patient 12 has on and off pain on both of his legs/foot and takes pain medication as needed. A review of Patient 12's LVN Visit Note dated 2/21/2023, indicated the section “Pain Profile” was left blank. There was no documented evidence Patient 12's pain level was assessed and documented using the pain rating scale. b. A review of Patient 13’s clinical record indicated a start of care (SOC) date of 12/15/2022, with a diagnosis that included encounter for attention to other artificial openings of urinary tract, and end stage renal disease (when the kidneys are no longer able to function normally). A review of Patient 13's Home Health Certification and Plan of Care for certification period from 2/13/2023 to 4/13/2023, included an order for the skilled nurse (SN) to visit Patient 13 once a week for nine weeks to continue for skilled assessment and observation of all body systems, vital signs every visit, and focus assessment on pain for location, character, intensity using the scale of 1-10 (10 as the most intense level). On 3/29/2023, at 12:55 p.m., a joint home visit with Licensed Vocational Nurse (LVN 2) was conducted at Patient 13’s residence. Patient 13 was observed awake, alert, oriented and ambulatory. A review of Patient 13's LVN Visit Note dated 2/15/2023 and 3/08/2023, indicated the section “Pain Profile” was left blank. There was no documented evidence Patient 13 pain level was assessed and documented using the pain rating scale. On 4/1/2023, at 3:45 p.m., during a concurrent interview and clinical record review with the Director of Patient Care Services (DPCS), the DPCS acknowledged the findings for Patient 12 and Patient 13 and stated the visiting nurse should assess the patient’s pain level using the pain scale of 0 to 10 on every SN visit in accordance with the physician’s order in the plan of care. A review of the agency’s policy and procedure titled “Pain Assessment,” revised November 2020, indicated pain assessments will be documented to facilitate regular reassessment and follow-up by clinicians. When the patient or the clinician identifies pain, pain assessment information will be obtained whenever possible including pain intensity using the rating scale (on a scale of 0-10: 0=no pain, 10=unbearable pain), pain location, pain quality, patterns of radiation and character, pain onset, and effects of pain.

Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This ELEMENT is not met as evidenced by: Based on interview and record review, the Home Health Agency (HHA) failed to ensure designated attending physician was notified and notifications were documented when ordered home visits services were missed for two of 17 sampled patients (Patients 1 and 15). This failure had the potential to result in patient’s condition to deteriorate with no immediate interventions due to the lack of physician notification by the HHA. Findings: A review of Patient 15's clinical record indicated a start of care (SOC) date of 1/24/2023 with a diagnosis that includes encounter for fitting and adjustment of urinary device, and Down syndrome (a genetic chromosome 21 disorder causing developmental and intellectual delays). A review of Patient 15's Home Health Certification and Plan of Care (POC) for certification period from 1/24/2023 to 3/24/2023, included an order for the skilled nurse (SN) to visit twice a week for 1 week and once a week for 8 weeks to perform skilled assessment and observation of all body systems, vital signs every visit, and record. A review of Patient’s 15 clinical records indicated there was a missed visit note dated 1/31/2023 and 2/08/2023, and under the section “Reason” for missed visit, it indicated “No answer to phone call”. A missed visit note dated 2/14/2023, under the section “Reason” and "Comment", it was blanked. There was no documented evidence the patient’s physician was notified about the SN missed visit. On 4/01/2023, at 3:45 p.m., during a concurrent interview and clinical record review with the Director of Patient Care Services (DPCS), the DPCS stated physician notification should be done promptly for missed visits and for the case of Patient 15, it was not done. A review of the agency’s policy and procedure titled “Monitoring Patient’s Response/Reporting to Physician,” revised November 2021, indicated clinicians will establish and maintain ongoing communication with the physician to ensure safe and appropriate care for the patient. The patient’s physician (or other authorized licensed independent practitioner) will be contacted on the same day when any of the following occur: when a visit is missed for any reason. A review of Patient 1’s face sheet indicated the patient was admitted to the home health agency on 7/29/22, with diagnoses including hemiplegia (paralysis on one side of the body) and encounter for fitting and adjustment of urinary device. A review of Patient 1's Plan of Care (POC) dated from 1/25/23 to 3/25/23, included an order for the skilled nurse (SN) to visit once a week for 9 weeks, to perform skilled assessment and observation of all body systems, vital signs every visit, and record. A review of Patient 1’s LVN 1 "Communication Notes" dated 1/23,1/26/23, 2/2, 2/7, 2/9 and 3/15/23 indicated that LVN 1 made a telephone call to Patient 1 but there was no answer to reach out for an appointment visit. However, there was no documented evidence LVN 1 made a second call and a drive-by at the patient’s residence on each date as per agency’s policy for missed visits. There was no documented evidence the patient’s physician was notified about the SN missed visit. On 4/01/2023, at 3:45 p.m., during a concurrent interview and clinical record review with the Director of Patient Care Services (DPCS), the DPCS stated physician notification should be done promptly for missed visits and for the case of Patient 1, it was not done.

Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient's plan of care, for each patient's medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This CONDITION is not met as evidenced by: Based on observation, interview, and record review the Home Health agency failed to ensure the Condition of Participation for the Organization and Administration of services was met as follows: The Home Health agency failed to: Ensure patient needs and services for one of 17 sampled patients, (Patient 1) was continually assessed. Patient 1 ran out of baclofen medication [medicine used to treat pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases] for a week and a half, and the visiting nurse did not check medications during the visits. This deficient practice had the potential to cause the affected patient the worst possible pain which can affect its highest practicable mental, physical, and psychosocial well-being. (Refer to G966) Ensure one of 17 sampled patients, (Patient 1), who had a foley catheter (tube that drains urine), was assessed of its urine characteristics for signs and symptoms of infection. This deficient practice resulted to the patient’s hospitalization and urinary tract infection. (Refer to G966) The cumulative effect of this systemic practice resulted in the agency failure to ensure they had a functioning organization administration of services. .

Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to: 1. Ensure the patient needs for one of 17 sampled patients, (Patient 1) was continually assessed. Patient 1 ran out of baclofen (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases] medication for a week and a half, and the visiting nurse did not check medications during the visits. This deficient practice had the potential to cause the affected patient the worst possible pain which can affect its highest practicable mental, physical, and psychosocial well-being. 2. Ensure one of 17 sampled patients, (Patient 1), who had a foley catheter (tube that drains urine), was assessed of its urine characteristics for signs and symptoms of infection. This deficient practice resulted to the patient’s hospitalization and urinary tract infection. A review of Patient 1’s face sheet indicated the patient was admitted to the home health agency on 7/29/22, with diagnoses that included hemiplegia (paralysis on one side of the body) and encounter for fitting and adjustment of urinary device. A review of Patient 1's Plan of Care (POC) dated from 1/25/23 to 3/25/23, included an order for the skilled nurse (SN) to visit once a week for 9 weeks, to instruct patient/caregiver on disease process, reportable signs/symptoms, complication and interventions, and compliance to prescribe medications, frequency, refills, and dosages. On 3/29/23, at 11 a.m., a home visit was conducted at Patient 1's residence with Registered Nurse 1 (RN). Patient 1 was observed sitting on her wheelchair with facial grimacing when moving her body around while sitting in her wheelchair. At 11:45 a.m., a review was conducted of Patient 1's current medications reconciling with the medication profile provided by the agency. It was observed Patient 1 had a bottle of Baclofen 10 mg one tablet three times a day, but the bottle was empty. When Patient 1 was asked when the last time she took Baclofen medication, she stated she ran out of baclofen medication since 3/10/23 and had no pain medication since then to relieve her constant aggravating pain. Patient 1 also stated her pain level was 8/10 (pain scale, the tool that healthcare professionals use to help assess a person's pain, 0 means no pain; one to three means mild pain; four to seven is considered moderate pain; eight and above is severe pain) in her back, left hip, bilateral legs, and ankles. She further stated the visiting nurse does not check her medications when visiting and the agency is aware of her pain status, but no one pays attention to her care. She further stated she could not stand the pain anymore and she will head to the emergency room (ER) today to help her out with her pain issue. Patient 1 also stated she called Case Manager 1 over the phone on 3/10/23 and made her aware that she was in aggravating pain and her baclofen medication had run out. She also stated that her foley catheter (a tube that drains urine) was not changed by the Licensed Vocational Nurse (LVN) one to two months and because of that, she developed a urinary tract infection (UTI) and had to go to the general acute hospital ER on 3/8/23, to have it changed and treated for a UTI. On 3/24/23, at 3:15 p.m., during an interview with the Director of Patient Care Services (DPCS), she stated Patient 1 strictly requested that LVN 1 would be the only nurse to change her foley catheter. The DPCS also stated that Patient 1’s foley catheter was last changed on 12/30/22 and further stated that Patient 1’s foley catheter has not been changed by LVN 1 since 12/30/22 to 3/7/23, in which, there was a communication note on 3/10/23 that indicated, Patient 1 told Registered Nurse 1 (RN 1) that she went to hospital’s emergency room on 3/8/23 by herself, to have her foley catheter changed because she had a UTI. A review of Patient 1’s “Communication Notes" dated 1/23,1/26/23, 2/2, 2/7, 2/9 and 3/15/23 indicated LVN 1 made a telephone call to reach out to Patient 1 for an appointment visit, however, nobody answered the call. There was no documented evidence LVN 1 made a second call and a drive-by at the patient’s residence on each date as per agency’s policy for missed visits. On 3/24/23, at 4 p.m., during an interview with the DPCS, the DPCS stated LVN 1 should have made a second call and a drive-by on the day he attempted the call to Patient 1 to schedule an appointment. A review of RN document titled "Supervisory Visits" on 1/24/23, 2/7, 2/22, 2/27/23 and 3/13/23, indicated there were certified home health assistant (CHHA) supervisory visits, however, there was no documented evidence that RN 1 addressed that Patient 1's foley was changed and an assessment of urine characteristics was done on the dates mentioned above. On 3/30/23, at 1 p.m., during an interview with Case Manager 1, she stated she talked to Patient 1 over the phone on 3/10/23 and was aware the patient was in pain and did not have any pain medication. She also stated she did a recertification visit at Patient 1's residence on 3/24/23 and mentioned to the patient that she will be with another palliative management group to help her with her pain management. When Case Manager 1 was asked if she followed up with Patient 1's physician regarding the patient's pain medication refill and existing pain status since 3/10/23 to 3/24/23, she stated she only worked on arranging to enroll the patient to a new palliative pain management group. On 4/3/23, at 12 p.m., during an interview with the DPCS, she stated Case Manager 1 should have coordinated with her and should have followed up with the physician regarding the patient’s existing pain status and the refill of her baclofen medication. A review of the agency's undated policy "Skilled Nursing Services," indicated the registered nurse regularly reevaluates the client needs and coordinates the necessary services.

The following reflects the findings of the California Department of Public Health during a Complaint visit. Complaint Numbers: 61176 Representing the Department of Public Health: Health Facilities Evaluator Nurse ID No. 22303 The inspection was limited to the specific complaint investigation and does not represent the findings of a full inspection of the facility. There were deficiencies issued for complaint number 61176

Information to patient CFR(s): 484.50(a)(1) Provide the patient and the patient's legal representative (if any), the following information during the initial evaluation visit, in advance of furnishing care to the patient: This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency (HHA) failed to inform the patient the reason of delay of services and failed to visit the patient as scheduled for one of two sample selected patients (Patient 1). This deficient practice placed the patient at a risk for a delay in care and services. Findings: A review of Patient 1's clinical record indicated the start of care was 10/12/21, with a primary diagnosis of displace bicondylar fracture of left tibia (broken bone on the shin). On 1/27/22 at 10 a.m., during an interview, Patient 1 stated he was upset that no nursing staff showed up to visit him for a week and he was not notified when they were coming. On 1/27/22 at 1 p.m., during an interview, the Director of Patient Care Services (DPCS) stated that the SN frequency order to visit the Patient 1 was once a week. The DPCS stated after the registered nurse (RN 1) did her initial visit on 10/12/21, the home health aide (HHA) had to follow-up with Patient 1's insurance to verify authorization for SN visit approval. The DPCS stated Licensed Vocational Nurse (LVN 1) did the next follow up visit on 10/20/21 (eight days later). The DPCS stated that from dates 10/13/21 to 10/19/21, there was no visit done while the HHA was waiting for the authorization approval from Patient 1's insurance. The DPCS further stated that Patient 1 was not informed about the reason for delay of service due to insurance approval issues. A review of Patient 1's plan of care from 10/12/21 to 12/10/21, indicated an order for skilled nursing (SN) visits once a week for nine weeks, for skilled assessment, evaluation and observation of all body systems with focus emphasis on integumentary status (skin). One of the nursing interventions was to assess surgical wound at left lower leg for healing/complications, teach patient/caregiver care of incision to prevent infection.