Every finding on record at R & A Home Health Services, Inc

The following reflects the findings of the California Department of Public Health during a Complaint Validation Survey from 5/23/2023 to 5/25/2023. Federal Intake # 98708 Representing the California Department of Public Health: Surveyor ID #22303, Health Facilities Evaluator Nurse Surveyor ID #44186, Health Facilities Evaluator Nurse Active patients: 51 Sample Size: 7 Home Visits: 3 The following Conditions of Participation not met: 484.55 Comprehensive Assessment of Patients 484.60 Care Planning, Coordination of Services, and 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 Participation for Comprehensive Assessment of Patients as follows: 1. The HHA failed to conduct a pain assessment identifying the location, character, and level of pain, in accordance with the agency’s policies and procedure, for two of seven sampled patients, (Patient 4 and Patient 6). This deficient practice had the potential to the delay in the notification of the physician and in providing prompt interventions to address the patients' pain. (Refer to G 518). 2. The HHA failed to, for two of seven sampled patients (Patients 1 and Patient 2); Perform a skin assessment for Patient 1, who had an open sacral wound and left leg laceration. This deficient practice resulted to the physician not notified of the significant changes of the wounds, that resulted to its worsening condition and patient's hospitalization to the general acute hospital for further wound management. Assess Patient 2's pedal pulses on the bilateral lower leg that has edema (an excess fluid or swelling). This deficient practice placed the patient at risk for complications and delay in the healing process. (Refer to G544) The cumulative effect of these systemic practices resulted in the home health agency's inability to ensure the provision of quality health care services in a safe manner. .

Completion of the comprehensive assessment CFR(s): 484.55(b) Standard: Completion of the comprehensive assessment. This STANDARD is not met as evidenced by: Based on interview and record review, the home health agency failed to conduct a pain assessment identifying the location, character, and level of pain, in accordance with the agency’s policies and procedure, for two of seven sampled patients, (Patient 4 and Patient 6). This deficient practice had the potential to the delay in the notification of the physician and in providing prompt interventions to address the patients' pain. a. A review of Patient 4's clinical record indicated a Start of Care Date (SOC) of 3/8/2022, with diagnoses which included pulmonary embolism (a condition in which one or more arteries in the lungs become blocked by a blood clot), thrombocytopenia (a condition that occurs when the platelet [tiny blood cells that help the body to form clots to stop bleeding] count in the blood is too low), and obesity (a disorder involving excessive body fat that increases the risk of health problems). A review of Patient 4's Home Health Certification and Plan of Care (POC) for the certification period from 5/2/2023 to 6/30/2023, included an order for the skilled nurse (SN) to visit the patient twice a week for one week, then three times a week for eight weeks for comprehensive skilled assessment, observation and evaluation of all body systems, assessment of vital signs (measure the basic functions of the body that includes body temperature, blood pressure, pulse and respiration [breathing], and pain control and management). The POC indicated the SN was to notify the physician of pain level greater than six out of ten (a pain scale that measures pain level from zero (0) to ten (10), score of zero indicates no pain, score of ten indicates unbearable/sever pain) and/or not relieved by prescribed medication. A review of Patient 4's Skilled Nursing Notes dated 5/10/2023, 5/12/2023, 5/15/2023, and 5/17/2023, indicated that Patient 4 was alert, oriented x 3 (refers to a person's level of awareness of self/people, place, and time) but forgetful. In the Skilled Nursing Notes, under the section “Pain Assessment”, the space for Pain Scale 1-10 was left blank. There was no other documentation indicating Patient 4's level of pain from 0 -10 was assessed. b. A review of Patient 6's clinical record indicated an SOC date of 2/8/2023, with diagnosis that included cellulitis (skin infection that causes redness, swelling, and pain) of right and left lower limb, and chronic venous insufficiency (a condition in which the veins have problems sending blood from the legs back to the heart). A review of Patient 6's Home Health Certification and Plan of Care (POC) for the certification period from 4/9/2023 to 6/7/2023, included an order for the skilled nurse to visit the patient three times a week for nine weeks for observation and assessment of all body systems, vital signs, and pain control and management. Patient 6's POC indicated for the SN to notify the physician of pain level greater than 6/10 and/or not relieved by prescribed medication. A review of Patient 6's Skilled Nursing Notes dated 5/10/2023, 5/12/2023, 5/15/2023, 5/17/2023 and 5/19/2023, indicated that Patient 6 was alert, oriented x 3 (to people, place, and time) but forgetful. In the Skilled Nursing Notes, under the section “Pain Assessment”, the space for Pain Scale 1-10 was left blank. There was no other documentation indicating Patient 6's level of pain from 0-10 was assessed. During an interview with Director of Patient Care Services (DPCS) on 5/25/2023 at 11:30 a.m., the DPCS stated that a pain assessment should include the intensity (level) of the pain. The DPCS stated that Patient 4's clinical notes dated 5/10/2023 to 5/17/2023, and Patient 6’s clinical notes dated 5/10/2023 to 5/19/2023 had no pain intensity documented and that it should have been documented in the patient’s clinical record. A review of the agency’s policy and procedure titled, “Pain Assessment” revised October 2019, indicated all patients will receive at least an initial pain assessment and assessments will be appropriate to the patient’s age, condition, and ability to understand. 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). The policy indicated ongoing assessment will be completed for patients identifying pain or at risk for pain and pain will be assessed as part of every patient contact if the patient repots pain or is at risk for pain.

Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient's condition warrants due to a major decline or improvement in the patient's health status, but not less frequently than- This STANDARD is not met as evidenced by: Based on observation, interview and record review, for two of seven sampled patients (Patients 1 and Patient 2), the home health agency failed to: 1. Perform a skin assessment for Patient 1, who had an open sacral wound and left leg laceration. This deficient practice resulted to the physician not notified of the significant changes of the wounds, that resulted to its worsening condition and patient's hospitalization to the general acute hospital for further wound management. 2. Assess Patient 2's pedal pulses on the bilateral lower leg that has edema (an excess fluid or swelling). This deficient practice placed the patient at risk for complications and delay in the healing process. A. A review of Patient 1's clinical record indicated a Start of Care Date (SOC) of 1/21/2023, with diagnosis that included chronic atrial fibrillation (a long standing chaotic and irregular arrhythmia). Patient 1 was transferred to a General Acute Aare Hospital (GACH 1) on 2/20/2023 for further evaluation of bilateral lower leg edema (swelling) due to cellulitis (a bacterial infection that makes the skin red and swollen). A review of Patient 1's Resumption of Care Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies) dated 3/3/2023, under the Integumentary/Skin section indicated the patient had bilateral lower extremities cellulitis without size measurement and skin assessment for odor, drainage, and description of the surrounding skin. A review of Patient 1's plan of care (POC) from 1/21/2023 to 3/21/2023, indicated an order for the skilled nurse to visit daily until 3/21/2023 to assess all body systems, vital signs (measure the basic functions of the body that includes body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check (measures the level of glucose in the blood), medication and diet compliance, and safety on every visit. The POC indicated skilled nursing interventions to the open wound to cleanse bilateral lower extremities with Normal Saline (a mixture of salt and water), pat dry, and wrap with Kerlix (a type of wound dressing) and ACE wrap (a dressing used to reduce swelling and inflammation to promote adequate blood flow and healing) with moderate compression daily. A review of Patient 1's Skilled Nursing Notes from 3/4/2023 to 3/20/2023, under Integumentary System (set of organs that form the external covering of the body) section, Licensed Vocational Nurse 1 (LVN 1) indicated no skin breakdowns and normal findings. During an interview with the LVN 1 on 5/25/2023 at 10:00 a.m., LVN 1 was asked if she did a skin assessment on patient's lower back and buttocks during her visits, LVN 1 stated she did not do the assessment because the first time she attempted, the patient was in a lot of pain and refused to move. LVN 1 stated Patient 1's bilateral lower extremities were assessed with no lacerations or open wounds and skin was intact during her visits. Further review of Patient 1's clinical record indicated no documented evidence that Patient 1 was refusing to be turned and having pain when being touched by the LVN 1 during her visits. During an interview with FM1 on 5/25/2023 at 11:00 a.m., FM1 stated Patient 1 developed his sacral pressure sore when he was discharged from the hospital on 3/3/2023. FM1 stated LVN 1 comes to visit Patient 1 for ten minutes and during visit, LVN 1 would just clean the patient's bilateral lower leg cellulitis and wrap with clean dressing and Kerlix, but never looked at the patient's back to see his wound. FM1 also stated that she found a skin laceration on Patient 1's left leg on 3/17/2023 and because of that Patient 1 was transferred to the hospital for further evaluation. A review of Patient 1's Discharge OASIS dated 3/17/2023, indicated Patient 1 was transferred to acute care hospital due to septic shock (a widespread infection causing organ failure). A review of Patient 1's acute care hospital Office/Clinic Notes dated 3/17/2023, indicated the following findings: a. Patient 1 had an unstageable (a full thickness tissue loss in which actual depth of the ulcer is completely obscured by slough [cast off] or eschar [falling away of dead skin] in the wound bed) sacro-gluteal (area of the buttock and lower spine) pressure ulcer (an injury to skin and underlying tissue resulting from prolonged pressure on the skin) measuring 15 x 17 x unable to determine depth at this time due to being obscured by necrosis (death of tissue). The record indicated 90 percent of the wound bed was soft with black necrotic tissue and 10 percent was yellow/adherent slough. The record indicated large amount of purulent (pus) exudate (the drainage that seeps out of the wounds). The Office/Clinic Note indicated wound treatment such as cleanse wound with Normal Saline, apply Alginate (a type of wound dressing to absorb wound fluids), and cover with abdominal pad (a highly absorbent dressing). b. Patient 1 had a wound laceration in the left lateral lower leg with wound measurements 12 cm x 0.5 cm x 0.2 cm (cm, a metric unit of length), wound bed with dusky pink tissue, and with small serosanguineous (a drainage consists of both blood and liquid part of the blood [serum]) exudate. The record indicated treatment of the wound to cleanse with Normal Saline, apply Steri-Strips (a thin bandage used for the treatment of laceration), ABD pads, and wrap with Kerlix bulky gauze. During an interview with the Director of Patient Care Services (DPCS) on 5/25/2023 at 2:00 p.m., DPCS stated LVN 1 failed to do a skin assessment and failed to notify the physician promptly if patient was unable to move due to pain and to obtain wound care orders as needed. B. A review of Patient 2's clinical record indicated an SOC date of 3/3/2023 with diagnosis that included cellulitis on bilateral lower extremities. A review of Patient 2's plan of care (POC) from 5/2/2023 to 6/30/2023, indicated an order for the skilled nurse to visit two times a week for one week, two times a week for six weeks, to assess all body systems, vital signs (measure the basic functions of the body that includes body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check (measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. The POC indicated skilled nursing interventions to cleanse bilateral lower extremities with Normal Saline, pat dry, apply Calcium Alginate AG (a dressing is intended for application in dry form on infected wounds), cover with 4x4 (four by four) dressing, abdominal pad, and wrap with Kerlix and ace wrap with moderate compression three times a week. A review of Patient 2's Resumption Of Care Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies) dated 5/17/2023, under the Integumentary/Skin section indicated the patient had a left and right leg stasis ulcers (a wound on the leg caused by abnormal and damaged veins) with yellow drainage and without size measurement. The record indicated dry and flaky skin area. On 5/25/2023 at 11:00 a.m., a home visit was conducted at Patient 2's residence with LVN 1. Patient 2 was sitting on his chair in the living room. Patient 2 was observed with edematous and swollen bilateral lower legs and feet. After washing his hands and wearing clean pair of gloves, LVN 1 removed the soiled 4x4 dressing and ABD dressing from the right lower leg. LVN 1 removed his soiled gloves, performed hand washing, wore new clean gloves, cleaned the entire swollen lower leg and edematous foot with Normal Saline, pat dried, removed soiled gloves, and washed his hands again. After wearing new gloves, LVN 1 applied Calcium Alginate AG, covered with 4x4 dressing, ABD, and wrapped with Kerlix and ACE wrap. LVN 1 did the same wound care procedure on Patient 2's left lower swollen leg and edematous foot. However, LVN 1 did not check if pedal or tibial pulses (a points in the foot and ankle to check circulation in the lower leg) were present in feet nor checked to determine the severity of the edema by applying pressure on the swollen foot to measure the depth of indention and record how long it takes for the patient's skin to rebound back to its original position. During an interview with LVN 1 on 5/25/2023 at 11:30 a.m., LVN 1 stated that he was nervous and he forgot to check the pedal pulses and for severity of edema on both foot during his wound care procedure. A review of Patient 2's Skilled Nursing Notes from 5/2/2023 to 6/30/2023, indicated no documented evidence that the visiting nurse checked the pedal pulses and severity of edema during nursing visits. During an interview with the DPCS on 5/26/2023 at 11:00 a.m., DPCS stated LVN 1 should be assessing Patient 2's pedal pulses and pitting (occurs when excess fluid builds up in the body part causing swelling and when pressure is applied to the swollen area, a "pit" or indentation will remain) edema on his both lower extremities for good blood circulation due to existing cellulitis. DPCS stated the visiting nurse should document in their notes that they assessed the patient's pedal pulse and checked existing edema on patient's feet during their visits. A review of the agency's undated policy and procedure titled, "Comprehensive Assessment," indicated the assigned staff member will assess the patient's physical and psychosocial status to determine the need, type of care/services and the need for further assessment, ongoing assessment will occur with each visit and necessary revision will be made to the plan of care.

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, interviews, and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation for Care Planning, Coordination of Services, and Quality of Care was met as follows: 1. The HHA failed to follow the written plan of care for two of seven sampled patients, (Patients 1 and 2). This failure had the potential to result in complications and a poor-quality care provided to the affected patients that could affect the highest practicable mental, physical, and psychosocial wellbeing of the patients under the agency's care. (Refer to G 572) 2. The HHA failed to develop and implement an individualized plan of care (POC) for the two of 7 sampled patients, (Patient 4 and Patient 7) receiving anticoagulant (blood thinners, to prevent and treat blood clots) medications. This failure had the potential to cause serious complications that could affect the patients’ health status and well-being. (Refer to G 574) 3. The HHA failed to ensure wound orders for an existing open sacral wound and skin laceration on left lower leg were obtained from the physician for one out of seven sample patients, (Patient 1). This deficient practice placed the patient's open wounds at risk for infection and delay in wound healing. (Refer to G 580) 4. The HHA failed to ensure, the physician was notified promptly of the sacral open wound and the skin laceration on the left lower leg, for one out of seven sampled patients, (Patient 1). This deficient practice placed the patient's open wounds at risk for infection and delay in wound healing. (Refer to G 590) The cumulative effect of these systemic practices resulted in the failure of the HHA to deliver statutorily mandated compliance with Federal Regulations for Care Planning, Coordination of Services, and Quality of Care to ensure highest quality health care is provided to patients assessed to receive home health services. .

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 observation, interview and record review, the agency failed to follow the written plan of care for two of seven sampled patients, (Patients 1 and 2). For Patient 1, the Licensed Vocational Nurse 1 failed to perform skin assessment on patient's existing unstageable sacro-gluteal (lower back to hip area) pressure ulcer and left lateral lower leg laceration during her visits. For Patient 2, Licensed Vocational Nurse 2 failed to assess the patient's pedal pulse (pulses on the foot) with an existing bilateral lower leg edema (swelling). This failure had the potential to result in complications and a poor quality care provided to the affected patients that could affect the highest practicable mental, physical and psychosocial wellbeing of the patients under the agency's care. a. A review of Patient 1's clinical record indicated a start of care date of 1/21/23, with diagnosis that included chronic atrial fibrillation (a long standing chaotic and irregular atrial arrhythmia). The patient was transferred to an acute hospital on 2/20/23, for further evaluation of bilateral lower leg edema due to cellulitis. A review of Patient 1's Resumption of Care Outcome and Assessment Information Set (OASIS, the instrument/data collection tool used to collect and report assessment data by home health agencies) dated 3/3/23, indicated under the Integumentary/Skin section that he patient had bilateral lower extremities cellulitis without size measurement and skin assessment for odor, drainage and description of surrounding skin. A review of Patient 1's plan of care from 1/21/23 to 3/21/23, included an order for the skilled nurse to visit daily until 3/21/23, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. One of the skilled nursing interventions was to cleanse bilateral lower extremities with Normal Saline, pat dry, and wrap with Kerlix and ACE wrap with moderate compression daily. A review of Patient 1's Skilled Nursing Notes from dates 3/4 to 3/20/23, indicated under Integumentary System section that Licensed Vocational Nurse 1 (LVN 1) have checked the boxes of no skin breakdowns and normal findings as part of her skin assessment for her visits. On 5/25/23, at 10 a.m., during an interview with LVN 1, when asked if she did a skin assessment on patient's lower back and buttocks during her visits, she stated she did not because the first time she attempted, the patient was in a lot of pain and refused to move. LVN 1 also stated the patient's bilateral lower extremities was assessed with no lacerations or open wounds and skin was intact during her visits. Further review of Patient 1's clinical record indicated no documented evidence that Patient 1 had refused to be turned and having pain when being touched by LVN 1 during her visits. On 5/25/23, at 11 a.m., during an interview with Patient 1's FM1, she stated the patient developed his sacral pressure sore when he was discharged from the hospital on 3/3/23. LVN 1 comes to visit the patient for 10 minutes, LVN 1 would just clean the patient's bilateral lower leg cellulitis and wrap with clean dressing and Kerlix but never look at the patient's back to see his wound. she also stated that she found a skin laceration on patient's left leg on 3/17/23, so that's why the patient was transferred to the hospital for further evaluation. A review of Patient 1's Discharge OASIS dated 3/17/23, indicated the patient was transferred to an acute hospital due to septic shock. A review of the acute hospital Office/Clinic Notes dated 3/17/23, indicated the following findings: a. The patient had an unstageable sacro-gluteal pressure ulcer measuring 15 x 17 x unable to determine depth at this time due to being obscured by necrosis. wound bed= soft, black necrotic tissue- 90 percent, yellow, adherent slough-10 percent exudate amount= large exudate type= purulent Treatment= cleanse wound with Normal Saline, apply Alginate, cover with ABD pad b. wound laceration= left lateral lower leg wound measurement= 12x0.5x0.2 wound bed= dusky pink tissue exudate= small exudate type= serosanguineous Treatment= cleanse with Normal Saline, apply steri strips, ABD pads, wrap with Kerlix bulky gauze. On 5/25/23, at 2 p.m., during an interview with the director of patient care services (DPCS), she stated LVN 1 failed to do a skin assessment and failed to notify the physician promptly if patient was unable to move due to pain and to obtain wound care orders as needed. b. A review of Patient 2's clinical record indicated a start of care date of 3/3/23, with diagnosis that included cellulitis on bilateral lower extremities. A review of Patient 2's plan of care from 5/2/23 to 6/30/23, included an order for the skilled nurse to visit two times a week for one week, two times a week for 6 weeks, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. One of the skilled nursing intervention was to cleanse bilateral lower extremities with Normal Saline, pat dry , apply Calcium Alginate AG, cover with 4x4 and ABD and wrap with Kerlix and ACE wrap with moderate compression three times a week. A review of Patient 2's Resumption Of Care Outcome and Assessment Information Set (OASIS, the instrument/data collection tool used to collect and report assessment data by home health agencies) dated 5/17/23, indicated under the Integumentary/Skin section indicated the patient had a left leg stasis ulcer without size measurement, with yellow drainage and a right leg stasis ulcer without size measurement, with yellow drainage and dry, flaky skin area. On 5/25/23, at 11 a.m., a home visit was conducted at Patient 2's residence with Registered Nurse 1(RN 1). Patient 2 was sitting on his chair in the living room. Patient 2 was observed with bilateral lower leg and feet swelling and edematous. RN 1 was observed initially washing his hands and donned clean pair of gloves. RN 1 removed the soiled 4x4 and ABD dressing on right lower leg. RN 1 removed his soiled gloves, washed his hands and donned new clean gloves, cleanse the entire swollen lower leg and foot with edema with Normal Saline, pat dry, removed soiled gloves and washed his hands. RN 1 donned new pair of gloves, applied Calcium Alginate AG, covered with 4x4 and ABD and wrap with Kerlix and ACE wrap. RN 1 did the same wound care procedure on his left lower swollen leg and edematous foot. However, RN 1 did not check the pedal or tibial pulses of both foot if present nor checking to determine severity of edema by applying pressure on swollen foot to measure depth of pit and how long it last. On 5/25/23, at 11:30 a.m., during an interview with RN 1, he stated he was nervous he forgot to check the pedal pulses and checking severity of edema on both foot during his wound care procedure. A review of Patient 2's Skilled Nursing Notes from dates 5/2/23 to 6/30/23, indicated no documented evidence the visiting nurse check the pedal pulses and severity of edema during nursing visits. On 5/26/23, at 11 a.m., during an interview with the DPCS, the DPCS stated the visiting nurse should be assessing Patient 2's pedal pulse and pitting edema on his both lower extremities for good blood circulation due to existing cellulitis. A review of the agency's undated policy and procedure titled, "Comprehensive Assessment," indicated the assigned staff member will assess the patient's physical and psychosocial status to determine the need, type of care/services and the need for further assessment, ongoing assessment will occur with each visit and necessary revision will be made to plan of care.

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 develop and implement an individualized plan of care (POC) for the two of 7 sampled patients, (Patient 4 and Patient 7) receiving anticoagulant (blood thinners-to prevent and treat blood clots) medications. This failure had the potential to cause serious complications that could affect the patients’ health status and well-being. a. A review of Patient 4's clinical record indicated a start of care date (SOC) of 3/08/2022, with diagnoses which included pulmonary embolism (a condition in which one or more arteries in the lungs become blocked by a blood clot), thrombocytopenia (a condition that occurs when the platelet count in your blood is too low), and obesity (a disorder involving excessive body fat that increases the risk of health problems). A review of Patient 4's Home Health Certification and Plan of Care ( POC) for the certification period from 5/02/2023 to 06/30/2023, included an order for the skilled nurse (SN) to visit the patient twice a week for 1 week, then three times a week for 8 weeks for comprehensive skilled assessment, observation and evaluation of all body systems, assessment of vital signs (measure the basic functions of your body that includes body temperature, blood pressure, pulse and respiration [breathing], and compliance and side effects of diet/medication regimen. A review of Patient 4's Medication Profile file indicated the patient was on Xarelto (anticoagulant) 20 milligrams (mg) one tablet by mouth once daily. On 5/24/2023 at 10:55 am, a home visit was conducted with the Licensed Vocational Nurse (LVN 3) at Patient 4’s residence. Patient 4 was alert, oriented and was sitting on a chair in the living room. LVN 3 checked Patient 4’s vital signs and medications. A further review of Patient 4's POC and clinical record did not indicate a care plan was developed identifying the use of the anticoagulant medication. b. A review of Patient 7's clinical record indicated a start of care date of 2/21/2023, with diagnoses which included lymphedema (swelling in an arm or leg caused by a lymphatic system blockage), essential hypertension (high blood pressure), and chronic embolism (a blocked artery caused by a foreign body, such as a blood clot or an air bubble) and thrombosis (formation of a blood clot inside one of your blood vessels) of other specified deep vein of left lower extremity. A review of Patient 7's Home Health Certification and Plan of Care for the certification period from 4/22/2023 to 6/20/2023, included an order for the skilled nurse (SN) to visit the patient three times a week for 9 weeks for comprehensive skilled assessment, observation and evaluation of all body systems, assessment of vital signs (measure the basic functions of your body that includes body temperature, blood pressure, pulse and respiration [breathing], and compliance and side effects of diet/medication regimen. A review of Patient 7's Medication Profile file indicated the patient was on Eliquis (an anticoagulant medication used to treat and prevent blood clots) 5 milligrams (mg) one tablet by mouth once daily. A further review of Patient 7's POC and clinical record did not indicate a care plan was developed identifying the use of the anticoagulant medication. On 5/25/2023 at 11:30 a.m., during an interview with Director of Patient Care Services (DPCS), the DPCS stated patients on an anticoagulant medication should have a care plan to monitor the patient for bleeding precautions. A review of the agency’s policy and procedure titled, “Care Planning Process” revised May 2022, indicated a written individualized plan of care will be initiated within five days of start of care and updated at least every 60 days, or as patient’s condition warrants. The patient-specific clinical plan of care includes all pertinent diagnoses, mental status, types of services/equipment, frequency of visits, goals, and interventions appropriate to each discipline, prognosis, rehabilitation potential, functional limitations, precautions, activities, nutritional requirements, food/drug allergies, medications, treatments, safety measures, instructions, discharge plan.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on interview and record review, the home health agency failed to ensure wound orders for an existing open sacral wound and skin laceration on left lower leg were obtained from the physician for one out of seven sample patients, (Patient 1). This deficient practice placed the patient's open wounds at risk for infection and delay in wound healing. A review of Patient 1's clinical record indicated a start of care date of 1/21/23, with diagnosis that included chronic atrial fibrillation ( a long standing chaotic and irregular atrial arrhythmia). The patient was transferred to an acute hospital on 2/20/23, for further evaluation of bilateral lower leg edema (swelling) due to cellulitis (inflammation of subcutaneous skin tissue). A review of Patient 1's Resumption of Care Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies) dated 3/3/23, indicated under the Integumentary/Skin section indicated the patient had bilateral lower extremities cellulitis without size measurement and no skin assessment for odor drainage and description of surrounding skin. A review of Patient 1's plan of care from 1/21/23 to 3/21/23, included an order for the skilled nurse to visit daily till 3/21/23, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. One of the skilled nursing interventions was to cleanse bilateral lower extremities with Normal Saline, pat dry, and wrap with Kerlix and ace wrap (type of bandage) with moderate compression daily. A review of Patient 1's Skilled Nursing Notes from dates 3/4 to 3/20/23, indicated under Integumentary System section that Licensed Vocational Nurse 1 (LVN 1) have checked the boxes of no skin breakdowns and normal findings as part of her skin assessment for her visits. On 5/25/23, at 10 a.m., during an interview with LVN 1, when asked if she did a skin assessment on patient's lower back and buttocks during her visits, she stated she did not because the first time she attempted, the patient was in a lot of pain and refused to move. She also stated the patient's bilateral lower extremities was assessed with no lacerations or open wounds and skin was intact during her visits. Further review of Patient 1's clinical record indicated no documented evidence that Patient 1 was refusing to be turned and having pain when being touched by LVN 1 during her visits. On 5/25/23, at 11 a.m., during an interview with Patient 1's FM1, she stated the patient developed his sacral pressure sore when he was discharged from the hospital on 3/3/23. LVN 1 comes to visit the patient for 10 minutes, LVN 1 would just clean the patient's bilateral lower leg cellulitis and wrap with clean dressing and Kerlix but never look at the patient's back to see his wound. she also stated that she found a skin laceration on patient's left leg on 3/17/23, so that's why the patient was transferred to the hospital for further evaluation. A review of Patient 1's Discharge OASIS dated 3/17/23, indicated the patient was transferred to an acute hospital due to septic shock. A review of the acute hospital Office/Clinic Notes dated 3/17/23, indicated the following findings: a. The patient had an unstageable sacro-gluteal pressure ulcer measuring 15 x 17 x unable to determine depth at this time due to being obscured by necrosis. wound bed= soft, black necrotic tissue- 90 percent, yellow, adherent slough (yellow/white material in the wound bed) 10 percent exudate amount= large exudate type= purulent Treatment= cleanse wound with Normal Saline, apply Alginate, cover with ABD pad b. wound laceration= left lateral lower leg wound measurement= 12 cm x 0.5 cm x 0.2 cm wound bed= dusky pink tissue exudate= small exudate type= serosanguineous (blood and liquid) Treatment= cleanse with Normal Saline, apply steri strips, ABD pads, wrap with Kerlix bulky gauze. On 5/25/23, at 2 p.m., during an interview with the director of patient care services (DPCS), she stated LVN 1 failed to do a skin assessment and failed to notify the physician promptly if patient was unable to move due to pain and to obtain wound care orders as needed.

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 failed to ensure, the physician was notified promptly of the sacral open wound and the skin laceration on the left lower leg, for one out of seven sampled patients, (Patient 1). This deficient practice placed the patient's open wounds at risk for infection and delay in wound healing. A review of Patient 1's clinical record indicated a start of care date of 1/21/23, with diagnosis that included chronic atrial fibrillation (a long standing chaotic and irregular atrial arrhythmia). The patient was transferred to an acute hospital on 2/20/23, for further evaluation of bilateral lower leg edema (swelling) due to cellulitis inflammation of the skin connective tissue). A review of Patient 1's Resumption of Care Outcome and Assessment Information Set (OASIS - The instrument/data collection tool used to collect and report assessment data by home health agencies) dated 3/3/23, indicated under the Integumentary/Skin section indicated the patient had bilateral lower extremities cellulitis without size measurement and no skin assessment for odor drainage and description of surrounding skin. A review of Patient 1's plan of care from 1/21/23 to 3/21/23, included an order for the skilled nurse to visit daily till 3/21/23, to assess all body systems, vital signs (measure the basic functions of your body that includes your body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level, severe shortness of breath, blood sugar check(measures the level of glucose in your blood), medication and diet compliance, and safety on every visit. One of the skilled nursing interventions was to cleanse bilateral lower extremities with Normal Saline, pat dry , and wrap with Kerlix and ACE wrap with moderate compression daily. A review of Patient 1's Skilled Nursing Notes from dates 3/4 to 3/20/23, indicated under Integumentary System section that Licensed Vocational Nurse 1 (LVN 1) have checked the boxes of no skin breakdowns and normal findings as part of her skin assessment for her visits. On 5/25/23, at 10 a.m., during an interview with LVN 1, when asked if she did a skin assessment on patient's lower back and buttocks during her visits, she stated she did not because the first time she attempted, the patient was in a lot of pain and refused to move. She also stated the patient's bilateral lower extremities was assessed with no lacerations or open wounds and skin was intact during her visits. Further review of Patient 1's clinical record indicated no documented evidence that Patient 1 was refusing to be turned and having pain when being touched by LVN 1 during her visits. On 5/25/23, at 11 a.m., during an interview with Patient 1's FM1, she stated the patient developed his sacral pressure sore when he was discharged from the hospital on 3/3/23. LVN 1 comes to visit the patient for 10 minutes, LVN 1 would just clean the patient's bilateral lower leg cellulitis and wrap with clean dressing and Kerlix but never look at the patient's back to see his wound. she also stated that she found a skin laceration on patient's left leg on 3/17/23, so that's why the patient was transferred to the hospital for further evaluation. A review of Patient 1's Discharge OASIS dated 3/17/23, indicated the patient was transferred to an acute hospital due to septic shock. A review of the acute hospital Office/Clinic Notes dated 3/17/23, indicated the following findings: a. The patient had an unstageable sacro-gluteal pressure ulcer measuring 15 x 17 x unable to determine depth at this time due to being obscured by necrosis. wound bed= soft, black necrotic tissue- 90 percent, yellow, adherent slough-10 percent exudate amount= large exudate type= purulent Treatment= cleanse wound with Normal Saline, apply Alginate, cover with ABD pad b. wound laceration= left lateral lower leg wound measurement= 12x0.5x0.2 wound bed= dusky pink tissue exudate= small exudate type= serosanguineous Treatment= cleanse with Normal Saline, apply steri strips, ABD pads, wrap with Kerlix bulky gauze. On 5/25/23, at 2 p.m., during an interview with the director of patient care services (DPCS), she stated LVN 1 failed to do a skin assessment and failed to notify the physician promptly if patient was unable to move due to pain and to obtain wound care orders as needed.

Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This CONDITION is not met as evidenced by: Based on observation, interview, and record review, the Home Health Agency (HHA) failed to ensure the Condition of Participation for Skilled Professional Services was met as follows: 1. The HHA staff failed to assess one of seven sampled patients (Patient 1), with his pain and ensure interventions were provided timely to relieve the pain. This deficient practice had the potential to affect the patient's highest practicable physical, mental, and psychosocial wellbeing. (Refer to G 710). 2. The HHA staff failed to provide, for one of seven sampled patients, (Patient 5), patient and caregiver education regarding insulin (an injectable medication used to treat diabetes [a chronic condition that affects the way the body processes blood sugar]) medication and its expiration date. This failure had the potential to affect the patient's medical condition when an expired insulin is being used to administer. (Refer to G 714). The cumulative effect of these systemic practices resulted in the failure of the home health agency's inability to deliver statutorily mandated compliance with the Federal regulations for Skilled Professional Services to ensure the provision of highest quality health care services in a safe environment. .

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 interview and record review, the home health agency failed to assess one of seven sampled patients (Patient 1), with his pain and ensure interventions were provided timely to relieve the pain. This deficient practice had the potential to affect the patient's highest practicable physical, mental and psychosocial wellbeing. A review of Patient 1's clinical record indicated a Start of Care Date of 1/21/2023, with diagnosis that included chronic atrial fibrillation (a long standing chaotic and irregular arrhythmia). A review of Patient 1's plan of care (POC) from 1/21/2023 to 3/21/2023, indicated an order for the skilled nurse to visit daily until 3/21/2023 to assess all body systems, vital signs (measure the basic functions of the body that includes body temperature, blood pressure, pulse and respiratory [breathing] rate), pain level and comfort status, severe shortness of breath, blood sugar check (measures the level of glucose in the blood), medication and diet compliance, and safety on every visit. A review of Patient 1's Skilled Nursing Visit notes dated 3/11/2023, 3/12/2023, 3/13/2023, 3/15/2023, and 3/16/2023, indicated Patient 1 had generalized pain with pain level of six out of ten (a pain scale measures pain level from zero to ten, score of zero indicates no pain, score of 6 indicates moderately strong pain, and score of ten indicates sever/unbearable pain) on a pain scale from zero to ten (6/10). However, the notes did not indicate if Patient 1 was further assessed with his pain and if any pain interventions were provided to the patient to relieve the pain. During an interview with the Director of Patient Care Services (DPCS) on 5/25/2023 at 12:00 p.m., the DPCS stated that the patient's pain should have been assessed before and after a pain intervention was provided to the patient to evaluate the effectiveness of the pain relief. A review of the agency's undated policy of "Pain Management", indicated when the patient or the clinician identifies pain, pain assessment information will be obtained including present pain management regimen and effectiveness.

Patient and caregiver education CFR(s): 484.75(b)(5) Patient and caregiver education; This ELEMENT is not met as evidenced by: Based on observation, interview, and record review, the home health agency failed to provide, for one of seven sampled patients, (Patient 5), patient and caregiver education regarding insulin (an injectable medication used to treat diabetes [a chronic condition that affects the way the body processes blood sugar]) medication and its expiration date. This failure had the potential to affect the patient's medical condition when an expired insulin is being used to administer. A review of Patient 5's clinical record indicated a start of care (SOC) date of 2/15/2023, with diagnoses which included Type 2 diabetes mellitus (a chronic condition that affects the way the body processes blood sugar [glucose]), encounter for other orthopedic aftercare, and chronic kidney disease (kidneys are damaged and can't filter blood the way they should). A review of Patient 5's Home Health Certification and Plan of Care (POC) for the certification period from 4/16/2023 to 6/14/2023, indicated an order for the skilled nurse (SN) to visit the patient daily except when seen by the physician for wound care, perform comprehensive skilled assessment, observation and evaluation of all body systems, assessment of vital signs (measure the basic functions of the body that includes body temperature, blood pressure, pulse and respiration [breathing], and compliance and side effects of diet/medication regimen. The POC indicated for the SN to teach and instruct patient/patient caregiver on conditions and disease process, management and complications of Type 2 diabetes mellitus including importance of strict compliance with prescribed treatment and medication regimen. A review of Patient 5’s Medication Record, indicated Patient 5 was on Levemir (long-acting insulin for diabetes) FlexTouch subcutaneous injection 25 units at bedtime, and Novolog (a rapid-acting insulin that helps lower mealtime blood sugar spikes) flex pen subcutaneous injection ten units three times a day before meal. During a home visit at Patient 5's residence with the Licensed Vocational Nurse (LVN 3) on 5/24/2023 at 10:10 a.m., Patient 5 was observed sitting in a sofa in the living room. During a review of Patient 5's medications with LVN 3, observed used Lantus FlexTouch insulin injection and used Novolog flex pen injection was not labeled and dated when it was first used. During an interview with Patient 5 on 5/24/2023 at 10:30 a.m., Patient 5 stated that she administers the insulin to herself as scheduled. Patient 5 stated she was not aware that Levemir FlexTouch will expire in 42 days and the Novolog flex pen will expire in 28 days upon opening or removing from the refrigerator. Patient 5 stated that the visiting nurse did not give instructions to place the date on the insulin bottle when it was first opened and/or removed from the refrigerator. A further review of Patient 5's Skilled Nursing Notes from 5/17/2023 to 5/21/2023, indicated no documented evidence the visiting nurse instructed the patient/caregiver regarding insulin management. During an interview with the Director of Patient Care Services (DPCS) on 5/25/2023 at 11:30 a.m., the DPCS stated the insulin medications should be dated once it was opened or first used. She also stated that the patient should have been provided patient teaching on insulin management as per the plan of care. A review of the agency’s policy and procedure titled, “Patient Education Process” revised October 2019, indicated patient and family/caregivers will receive education in verbal, visual, and written format, as appropriate. The scope of teaching will be determined by assessing the needs, abilities, learning preferences, and readiness to learn of the patient and family/caregiver, as well as by the plan of care. Education will be the responsibility of each clinician and will focus on enhancing the patient’s and family/caregiver’s role in continuing care and maintaining the patient’s health status.