Home Health By John Knox Village

“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 policy review, record review, home visit observation, and interview, the home health provider failed to ensure staff performed a complete medication review in one of five full records reviewed (Record/Patient #1). This deficient practice has the potential to affect all of the patients served by the provider. Findings included: Review of the provider’s policy titled, “Medication Management,” revised on 10/15/2024, showed in part that the admitting clinician will enter into the electronic medical record (EMR) all medications, including prescription and non-prescription, as well as frequency and route of administration. RECORD/PATIENT #1: Review of the face-to-face record, dated 04/22/2025, showed the discharge medication list that included Zetia (a medication used to treat high cholesterol) 10 milligrams (mg) daily. Review of the clinical record, showed in part: - The patient was admitted to home health services on 05/19/2025 with a primary diagnosis of encounter for change or removal of surgical wound dressing; and - The patient resided at home alone. Review of the plan of care medication profile dated 05/19/2025 to 07/17/2025, failed to include Zetia. Observation on 05/28/2025, beginning at 12:00 PM showed: - The patient was taking Zetia; and - The medication profile was updated to include Zetia. During an interview on 05/29/2025 that began at 10:45 AM, the therapy coordinator and the clinical manager stated that the Zetia should have been on the medication profile at the start 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 policy review, record review, home visit observation, and interview, the provider failed to develop a complete/individualized plan of care (POC), in two of five full records reviewed (Records/Patients #1 and #2). This deficient practice has the potential to affect the care for all the patients served by the provider. RECORD/PATIENT #1: Review of the clinical record, showed in part: - The patient was admitted to home health services on 05/19/2025 with primary diagnosis of encounter for change or removal of surgical wound dressing; and - The patient resided at home alone. Review of the POC dated 05/19/2025 to 07/17/2025, showed in part: - An additional diagnosis of peripheral vascular disease (a circulatory condition in which narrowed blood vessel reduce blood flow to the limbs); - Skilled nursing (SN) to assess cardiovascular stats, identify and signs and symptoms of impaired cardiovascular function. SN to instruct on disease process, including who to contact if signs and symptoms persist or worsen as well as dietary measures, medication management, activities permitted; and - The POC failed to include interventions specific to edema (swelling of the tissues). During home visit observation on 05/28/2025, beginning at 12:00 PM showed, in part: - The patient had non-pitting edema to the right foot; and - The SN educated the patient to elevate lower extremities to reduce edema. During an interview on 05/29/2025 that began at 10:45 AM, the therapy coordinator and the clinical manager stated that the POC included interventions related to the cardiovascular system but not specifically for edema. Findings included: Review of the home health provider’s policy titled, “Start of Care Assessment”, dated revised “1/24/23”, showed in part: - The initial home health visit will be a comprehensive patient assessment to evaluate the patient’s specific need for home care including medical, nursing, rehabilitative and social services; - The start of care (SOC) assessment must include, at a minimum, the patient’s current health status; and - The patient’s individualized POC will be developed from the information gathered during the SOC assessment. Review of the home health provider’s policy titled, “Care Planning Process”, dated revised “2/8/22”, showed in part: - The POC should be initiated at SOC, and be an individualized, collaborative document that is contributed to by each discipline, as well as the patient/caregiver; - A written POC will be initiated within five (5) days of SOC and updated at least every 60 days or with any significant change in the patient’s condition; - The following factors should be considered during the care planning process: * Individualized patient needs; and * Symptom management, as appropriate; and - The POC may include but will not be limited to individualized goals and interventions. RECORD/PATIENT#2: Review of the clinical record showed the patient was admitted to home health services on 05/23/2025 with a primary diagnosis of encounter for change or removal of non-surgical wound dressing to a sacral pressure ulcer (skin injury caused by unrelieved pressure to the tail bone area). The patient also had diagnoses of atherosclerotic heart disease (damage or disease in the hearts major blood vessels. The usual cause is the buildup of plaque which causes the coronary arteries to narrow limiting blood flow to the heart), cardiomyopathy (a disease of the heart muscle which makes it hard for the heart to deliver blood to the body, and can lead to heart failure), and history of venous thrombosis (a stationary blood clot formation in a vein) and embolism (often caused when a thrombus or piece of a thrombus breaks off from where it is formed and travels to another area of your body) . The patient lived at home with a spouse. Review of the SOC OASIS (Outcome and Assessment Information Set; a standardized data collection tool), dated 05/23/2025 showed in part: - “2+ pitting edema” (moderate swelling of the tissues, that when pressing on the skin leaves a slight indentation (three to four mm (millimeters)) that takes less than 15 seconds to disappear, suggesting a moderate level of fluid buildup) to the bilateral lower extremities; and - Patient was instructed on daily weights, signs and symptoms of heart failure, elevating lower extremities, and skin care to feet and legs. Review of the POC dated 05/23/2025 to 07/21/2025 failed to show any specific interventions or goals related to the lower extremity edema. Review of the skilled nurse (SN) visit note dated 05/28/2025 showed: - The patient had “3+” edema (swelling of the tissues, that when pressing on the skin leaves an indentation (five to six mm) that takes up to 60 seconds to rebound) to the bilateral lower extremities; and - The patient was educated and agreed to put feet up in the recliner; - Educated/discussed the use of TED hose (also known as anti-embolism stockings designed to prevent blood clots and swelling in the legs), tubi-grip (a multi-purpose elasticated tubular bandage designed for the management of swelling), compression wraps (also known as a compression bandage designed to apply gentle consistent pressure to a body part to reduce swelling), but the patient stated that he/she does not and will not wear them; and - “Named” registered nurse (RN) at the attending physician’s office was notified of the edema and refusal to wear anything related to compression. Observation on 05/28/2025 at 1:04 PM during the patient’s home visit showed: - Three plus edema to bilateral lower extremities; - The patient agreed to elevate legs to assist in reducing swelling; and - The patient stated that he/she would not wear TED hose, tubi-grips or compression wraps. During an interview on 05/29/2025 starting at 10:45 AM, when discussing the failure of the POC containing interventions or goals for the management of edema, the therapy manager stated that the POC did mention cardiovascular status and to instruct on the disease process. During an interview on 05/29/2025 starting at 10:45 AM, when discussing the failure of the POC containing interventions or goals for the management of edema, the administrator stated that the information was on the POC, it was just “a pretty broad statement.” During an interview on 05/29/2025 starting at 10:45 AM, the clinical manager stated that their electronic medical record (EMR) did not have a specific template for management of edema, but they could create one.”

“Interdisciplinary assessment of the patient CFR(s): 484.75(b)(1) Ongoing interdisciplinary assessment of the patient; This Element is not met as evidenced by: Based on policy review, job description review, record review, and interview, the home health provider failed to ensure the ongoing interdisciplinary assessment of the patient, in one of five full records reviewed (Record/Patient #3). This deficient practice has the potential to affect the coordination of care and services for all the patients served by the provider. Findings included: Review of the home health provider’s policy titled, “Care Coordination and Ongoing Communication,” dated revised “4/8/25” showed, in part: - All associates, assigned to a patient’s care, will be responsible for communicating within the patient’s care team; - Purpose: To ensure the interdisciplinary communication and coordination of services for each patient; - It will be the responsibility of the case manager to facilitate coordination between disciplines, including, but not limited to, initiation of communication with other team members when there are significant changes in the patient’s overall condition and/or care; and - All orders for additional disciplines obtained after admission will be documented in the clinical record and communicated to the appropriate clinician. (The policy failed to include a time frame for initiating the evaluation visit). Review of the home health provider’s job description titled, “Clinical Manager,” dated revised “7/2018”, showed in part: - The clinical manager is responsible for the coordination of patient/family home health/hospice care by direct supervision of the clinical team; - Duties include coordination of staff schedules; - The clinical manager conducts or ensures consistent, accurate and timely communication among all members of patient care teams, families, patients, caregivers, service providers, etc (et cetera- and the rest, additionally); and - The clinical manager assures staff assignments are planned and completed as expected. RECORD/PATIENT #3: Review of the clinical record showed: - The patient was admitted to home health services on 05/07/2025 with a primary diagnosis of hypertensive heart disease with heart failure (a condition where heart problems, including heart failure (occurs when the heart muscles do not pump blood as well as it should), develop due to prolonged high blood pressure); and - The patient lived in a senior living apartment alone, with a neighbor and child that frequently assisted with his/her needs. Review of a physician order dated 05/13/2025 showed: - Speech Therapy (ST) to assess communication disorder, swallowing disorder or cognitive dysfunction; and - ST to establish a plan of care as approved by the physician. Further review of the clinical record showed: - A ST evaluation dated 05/19/2025 (six days later); and - The record failed to contain documentation of why the evaluation was not completed until six days later. During an interview on 05/29/2025 starting at 10:45 AM, the therapy manager stated that: - Best practice for completion of the evaluation was within five days of receiving the order; - He/she saw the ST went on the sixth day; and - The order was not posted until 4:30 PM so the ST may not have seen it until the next day.”

“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 policy review, record review, home visit observation and interview, the home health provider failed to meet the requirements for the Condition of Participation: Care planning, coordination of services, and quality of care when the provider failed to ensure: - Each patient must receive an individualized written plan of care including, but not limited to, all medications and treatments, patient-specific interventions and education, measurable outcomes, and goals (G574); - Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner (G580); and - The home health agency must promptly alert the relevant physician(s) or allowed practitioner(s) to any changes in the patient’s condition or needs that suggest the outcomes are not being achieved and/or that the plan of care should be altered (G590). The cumulative effect of these systemic deficient practices has the potential to adversely affect the quality of care for all the patients served by the home health provider.”

“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 policy review, clinical record review, home visit observation, and interview, the home health provider failed to ensure that each patient’s written individualized plan of care (POC) included all required elements in two of four records reviewed (Records/Patients #2 and #4). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Care Planning Process,” revised 02/08/2022, showed, in part: - To outline the procedure for creating and updating the plan of care: * A written plan of care (POC) will be initiated within five (5) days of start of care and updated at least every 60 days or with any significant change in the patient’s condition; - The following factors should be considered during the care planning process: * Individualized patient needs; * Pain and symptom management, as appropriate; - The POC may include, but not be limited to: * Individualized goals and interventions; * Specific services to be provided; * Safety measures; * Equipment and supplies required; * Medications and treatments; - During each home visit, the clinician will monitor the patient’s response to care against the established POC; and - In the event that the patient is not achieving goals and the POC needs to be altered, the physician will be notified. Review of the provider’s policy titled, “Pain Assessment and Reporting,” revised 10/03/2023, showed, in part, the following: - If the patient reports significant and/or abnormal pain, it will be reported to the patient’s physician or approved practitioner; - When the patient or clinician identifies pain, the pain assessment may include, but not limited to: * Pain intensity using a rating scale (on a scale of 0-10; zero equals no pain and 10 equals unbearable pain); and - The physician or approved practitioner will be contacted if the patient reports pain that is significant and abnormal or based on clinical judgement. RECORD/PATIENT #2 Review of the recertification (follow-up) reassessment, dated 08/18/2023, showed the following: - Start of care 04/27/2022; - The patient had constant low back pain, rated it a seven (moderate pain), the best the pain got was a seven and the worst was 10 (severe), the pain was sharp and increased with activity, and was relieved by distraction, medication management, relaxation, and repositioning; - The patient had a Stage 2 (two) pressure ulcer (partial thickness loss of dermis presenting as a shallow open ulcer with a red or pink wound bed, without slough or bruising) to the left lateral (outer) buttock. The pressure ulcer was not healing, and the skilled nurse was to perform wound care to the buttocks as ordered/needed for chronic pressure areas “barrier cream (protects the skin and helps prevent pressure ulcer from developing) or Aquacel Ag (a dressing indicated for the management of a variety of at risk/infected chronic and acute wounds)”; - Skilled nursing services for weekly skin assessment/wound care; and - The patient reported a fall the week prior while going down the road in an electric wheelchair, he/she hit a curb and fell forward and reported that his/her back pain might be a little worse. Review of the POC dated 08/20/2023 through 10/18/2023 showed: - Start of care 04/27/2022; - Primary diagnosis of Stage 2 pressure ulcer to the left buttock; - Other pertinent diagnosis included chronic pain; - Skilled nursing two times weekly for eight weeks to teach/assess/monitor for skin integrity/pressure ulcer prevention and pain interventions to alleviate pain; - Order for treatments: Wound care to the Stage 2 pressure ulcer on the left buttock: Cleanse wound with normal saline, pat dry with 4 X 4 (4 inch by 4 inch gauze), apply Aquacel Ag/equivalent, cover with bordered foam (a dressing designed to deal with moderate to high levels of wound exudate), and secure with tape if needed. Skilled nurse to perform dressing changes two times weekly; - Care summary: The pressure ulcer was not healing, and the skilled nurse was to perform wound care to the buttocks as ordered/needed for chronic pressure areas “barrier cream or Aquacel Ag/bordered foam”; - Goals/rehabilitation/discharge plans, dated “04/27/2022”, showed: * Patient will demonstrate effective levels of pain control as evidenced by acceptable scores on standardized pain scale and ability to verbalize understanding of methods to monitor and mitigate pain by agency discharge of “06/01/2022”; * Patient/caregiver will demonstrate understanding of fall precautions and will be free of falls by agency discharge by “06/01/2022”; and * Patient /caregiver demonstrates proper techniques to prevent the development of skin breakdown and the patient will remain free of developing pressure ulcers by agency discharge on “06/01/2022”. The POC failed to be individualized and include: - Patient and caregiver specific education regarding pain and wound care; - Where the pain was located, acceptable level of pain and when to notify the physician; - Individualized pain interventions to alleviate pain; - Individualized fall precautions; - Updated goals for pain and the identified Stage 2 pressure ulcer and fall precautions; and - Clarification of barrier cream use (on the wound and surrounding skin). During an interview on 11/14/2023 at 2:47 PM, the director of nursing (DON) stated that he/she could see the goals but did not see any interventions, nursing looks at the orders and clinical notes for any changes with the patient. The patient was an amputee and was fully mobile, he/she transferred to and from his/her wheelchair with a pulley system, he/she had a gel cushion in his/her chair and staff used barrier cream on the surrounding skin of the wound. The patient was unable to provide his/her own wound care. The patient was educated on how to check his/her skin, notify the home health agency (provider) if his/her dressing fell off, and he/she was to notify the agency of any order changes after physician visits. He/she was unable to find this information on the POC. RECORD/PATIENT #4 Review of the referral information, dated 10/12/2023, showed the following: - Home health ordered to change dressing daily with Aquacel Ag; and - Right foot cellulitis (common and potentially serious bacterial skin infection) and to contact the office if the cellulitis continued to spread despite treatment, or if the patient developed fevers or chills while on antibiotics. Review of the start of care assessment, dated 10/24/2023, showed the following: - The patient had chronic low back pain and the worst the pain got was a five. The pain increased with activity or standing and was relieved by distraction, medication management, relaxation, and repositioning; -The patient was on dialysis (a procedure where a dialysis machine and a special filter called an artificial kidney are used to clean your blood); - The patient was referred to home health due to a reopened diabetic ulcer (wounds or sores usually found on the bottom of feet) to the right heel; and - He/she had a caregiver that provided meal prep, cleaning assistance with bathing, and medication set up and a family member that provided transportation. Review of the physical therapy evaluation and reassessment dated 11/02/2023, showed therapy was to assess/monitor/instruct patient/caregiver in alternative pain management techniques such as relaxation, distraction, massage, hot and cold packs, and other modalities as indicated. Review of the POC dated 10/24/2023 through 12/22/2023, showed the following: - Primary diagnosis type two diabetes mellitus (a group of diseases that result in too much sugar in the blood) with a foot ulcer; - Other pertinent diagnoses included non-pressure chronic ulcer of the right heel and midfoot with fat layer exposed and cellulitis of the right lower limb; - Dependent on renal dialysis; - Safety measures included skin breakdown precautions; - Assess/monitor/instruct patient/caregiver in medications to monitor and medicate pain; - Instruct/monitor patient in alternative pain management techniques such as massage, hot and cold packs and menthol preparations (topical application used to relieve pain); - Dialysis Monday, Wednesday, and Friday; - Skilled nursing one time weekly for eight weeks to perform wound care to the right foot diabetic ulcer; and - Skilled nursing to provide wound care to the right heel, skilled nurse to perform dressing changes on Tuesday and podiatry to perform on Thursday, and patient/caregiver to perform on all other days. The POC failed to be individualized and include: - Where the dialysis shunt (how patients are connected to the dialysis machine) was located; - Problem, interventions and education for the cellulitis; - Where the pain was located, acceptable level of pain and when to notify the physician regarding the pain; - Specific physician orders for use of hot and cold packs, massage, and menthol preparations; - There was no caregiver identified for the dressing changes and specific education and return demonstration regarding the dressing changes; - Interventions to monitor skin for breakdown; and - Specific goals for discharge. Observation on 11/14/2023 at 9:38 AM, during the patient’s home visit, showed the following: - Licensed practical nurse (LPN) A changed the dressing to the patient’s right heel ulcer, he/she did not remove the patient’s sock from his/her left foot and assess the skin; - LPN A asked the patient which arm he/she would prefer the blood pressure taken from and was not aware of the dialysis shunt; and - LPN A state that he/she does not initiate or change the POC, the office does that, typically he/she visits the same patient so he/she looks at the chart for the information needed. Per interview conducted during the observation, the patient stated that: - He/she took two Tylenol (used to treat pain or fever) prior to dialysis and had a dialysis shunt in his/her right upper arm; - His/her right foot sometimes caused pain and the pain was relieved with Tylenol; - He/she visited the podiatrist once a week, the patient only changed his/her dressing every other day because the wound care products were so expensive, and the podiatrist would like the dressing changed daily. He/she was unaware that home health would supply the wound care products; - The staff had never looked at his/her left foot; - He/she had only changed his/her dressing once because it was too hard to reach his/her foot; and - There was not a specific caregiver, who could routinely, change the dressing. During an interview on 11/14/2023 at 2:47 PM, the administrator and DON stated that they expected the POC to be individualized. Staff should be doing skin assessments. The patient’s acceptable pain score was derived from the patient’s acceptable pain level. The agency’s interventions did not pull over to the 485 (home health certification and plan of care signed by the physician). They are currently in the process of a new computer system that will allow them to individualize the plan of care.”

“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 policy review, clinical record review, and interview, the home health provider failed to ensure services and treatments were administered only as ordered by a physician in one of four records reviewed (Record/Patient #2). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “Orders (Including Verbal and Interim),” revised 01/17/2023, showed all medications, treatments and services that are part of the patient’s plan of care and provided to patients must be ordered by a physician or allowed practitioner. RECORD/PATIENT #2 Review of the plan of care (POC) dated, 08/20/2023 through 10/18/2023 showed: - Primary diagnosis of Stage 2 (two) pressure ulcer (partial thickness loss of dermis presenting as a shallow open ulcer with a red or pink wound bed) to the left buttock; - Skilled nursing two times weekly for eight weeks to teach/assess/monitor for skin integrity/pressure ulcer prevention and pain interventions to alleviate pain; and - Skilled nurse to perform wound care to Stage 2 pressure ulcer on the left buttock: Cleanse wound with normal saline, pat dry with 4 X 4 (4 inch by 4 inch gauze), apply Aquacel Ag (a dressing that absorbs wound fluid)/equivalent, cover with bordered foam (a dressing designed to deal with moderate to high levels of wound exudate), and secure with tape if needed. Review of the skilled nurse assessment notes, dated 08/24/2023 and 08/29/2023 showed: - A Stage 3 (three) pressure ulcer (full-thickness tissue loss) to the upper medial (toward middle or center) left buttock; - Pressure ulcer care was provided per the physician’s order (the physician order was for a Stage 2 pressure ulcer); and - The documentation failed to show a physician order for the treatment of the Stage 3 pressure ulcer. Review of the skilled nurse assessment note, dated 08/31/2023, showed: - The patient was currently being treated for an infection and failed to include type of infection and if it was a new infection since the last nursing visit (documentation failed to show a physician order for treatment of an infection); - The patient had constant shoulder pain rated a ten (severe pain) and the patient took baclofen (used to treat muscle spasms) that morning (documentation failed to show an order for baclofen); - A Stage 3 pressure ulcer to the left lower lateral buttock and wound care done per order (the physician order was for a Stage 2 pressure ulcer); and - The patient had baclofen (documentation failed to show a physician order) added to his/her medication. Review of the skilled nurse assessment notes, dated 09/05/2023 and 09/07/2023, showed: - A Stage 3 pressure ulcer to the left lower buttocks; - Wound care was done per order (the physician order was for a Stage 2 pressure ulcer); and - The documentation failed to show a physician order for the treatment of the Stage 3 pressure ulcer. Review of the skilled nurse assessment note, dated 09/15/2023, showed: - The patient was treated for a wound infection on the coccyx (a small triangular bone at the base of the spinal column); - Wound care was not done per the patient’s request, the patient stated his/her cousin had changed the dressing the day prior, and the nurse offered to put on a new dressing and the patient declined; - The Stage 3 pressure ulcer was not assessed per the patient’s request; and - The POC continued to show treatment for a Stage 2 pressure ulcer. Review of the skilled nurse assessment, dated 09/19/2023, showed: - An Unstageable pressure ulcer (an obscured full-thickness skin and tissue loss) to the left upper medial buttocks; - The wound was cleansed with wound cleanser, covered with AquaCel Ag, bordered foam and secured with hypafix tape (the treatment was for a Stage 2 pressure ulcer); and - The documentation failed to show a physician order for treatment of the unstageable pressure ulcer. Review of the skilled nurse assessment note, dated 09/22/2023, showed: - An Unstageable pressure ulcer to the left medial buttocks that was not assessed; and - The patient stated the caregiver changed the dressing the day prior (the POC still only showed a treatment for a Stage 2 pressure ulcer). Review of the skilled nurse assessment note, dated 09/26/2023, showed: - An Unstageable pressure ulcer to the left upper medial buttocks that was not assessed; - The patient had diminished lung sounds, wheezing, and a cough; - During the visit the patient became more pale, lethargic, and stated he/she did not feel well; and - The patient agreed to go to the emergency room, when the emergency medical technician arrived the pressure ulcer on the buttocks was discussed and the possibility of an infection. During interview on 11/14/2023 at 9:41 AM, LPN A stated that he/she should have wound orders for treatment of wounds. During an interview on 11/14/2023 at 2:47 PM, the administrator stated that he/she would expect staff to follow the physician orders.”

“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 policy review, record review, and interview, the home health provider failed to promptly alert the physician to changes in the patient’s condition or needs that suggest that outcomes are not being achieved and/or that the plan of care (POC) should be altered, in one of four records reviewed (Record/Patient #2). This deficient practice has the potential to affect all patients served by the provider. Findings included: Review of the provider’s policy titled, “On-going Clinical Assessment/Significant Change in Condition (SCIC),” revised 05/23/2023, showed, in part, the following: - To provide guidelines for clinical assessments of patients during on-going care; - Patient comprehensive reassessments will be performed periodically during the course of care or services: - Ongoing clinical assessments may occur upon: * Significant change in condition (SCIC) (major improvement or decline in a patient’s condition that was not envisioned in the original POC; and - It is the responsibility of clinical staff to report changes to the physician, as appropriate, and document this communication in the medical record. Review of the provider’s policy titled, “Care Planning Process,” revised 02/08/2022, showed, in part, during each home visit, the clinician will monitor the patient’s response to care against the established plan of care (POC). In the event that the patient is not achieving goals and the POC needs to be altered, the physician will be notified. Review of the provider’s policy titled, “Wound Care Assessment,” revised 10/03/2023, showed, in part, the following: - The agency is committed to providing a comprehensive wound management program to promote optimal healing of wounds; - Assess wounds during each nursing visit and document in the patient’s chart; - Wound measurements are to be documented weekly; and - The physician will be notified of new or deteriorating wounds, and any lack of progress in healing, wound complications, or poor response to treatment. Review of the provider’s policy titled, “Pain Assessment and Reporting,” revised 10/03/2023, showed, in part, the following: - If the patient reports significant and/or abnormal pain, it will be reported to the patient’s physician or approved practitioner; - When the patient or clinician identifies pain, the pain assessment may include, but not limited to: * Pain intensity using a rating scale (on a scale of 0-10; zero equals no pain and 10 equals unbearable pain); and - The physician or approved practitioner will be contacted if the patient reports pain that is significant and abnormal or based on clinical judgement. RECORD/PATIENT #2 Review of the physician order dated 07/26/2023 showed: - Wound care to Stage 2 (two) pressure ulcer (partial thickness loss of dermis presenting as a shallow open ulcer with a red or pink wound bed, without slough or bruising) “X 2” to the left buttock; - Cleanse with wound cleanser/normal saline, pat dry with 4 x 4 (4 inch x 4 inch gauze pad); - Apply Aquacel Ag/equivalent (a dressing indicated for the management of a variety of at risk/infected chronic and acute wounds); - Cover with bordered foam (a dressing designed to deal with moderate to high levels of wound exudate); - Secure with tape if needed; - Skilled nurse to perform dressing changes two times weekly; and - Caregiver may perform dressing change as needed when soiled. Review of the recertification (follow-up) reassessment, dated 08/18/2023, showed the following: - Start of care 04/27/2022; - The patient had constant low back pain, rated it a seven (moderate pain), and the best pain got was a seven; - The patient had a Stage 2 pressure ulcer to the left lateral (outer) buttock that measured 3 cm (centimeters) length by 3 cm width and .20 cm depth. The wound bed showed 100 percent granulation (the development of new tissue and blood vessels in a wound during the healing process) tissue. The pressure ulcer was not healing and the skilled nurse was to perform wound care to the buttocks as ordered/needed for chronic pressure areas “barrier cream (protects the skin and helps prevent pressure ulcer from developing) or Aquacel Ag (a dressing indicated for the management of a variety of at risk/infected chronic and acute wounds)”; and - The wound was not acquired under care. Review of the POC dated, 08/20/2023 through 10/18/2023 showed: - Primary diagnosis of Stage 2 pressure ulcer to the left buttock; - Other pertinent diagnosis included chronic pain and absence of the left and right leg above the knee; - Skilled nursing two times weekly for eight weeks to teach/assess/monitor for skin integrity/pressure ulcer prevention and pain interventions to alleviate pain; - Order for treatments: Wound care to Stage 2 pressure ulcer on the left buttock: Cleanse wound with normal saline, pat dry with 4 X 4 (4 inch by 4 inch gauze), apply Aquacel Ag/equivalent, cover with bordered foam, secure with tape if needed; and - Care summary: The pressure ulcer was not healing and the skilled nurse was to perform wound care to the buttocks as ordered/needed for chronic pressure areas “barrier cream or Aquacel Ag”. Review of a missed visit fax form dated 08/22/2023, showed the patient declined his/her visit due to a physician’s appointment and did not need a visit that day. Review of a skilled nurse assessment note, dated 08/24/2023, showed: - The patient had constant low back pain and rated it an eight (severe pain) and the aggravating factors were unknown; - A Stage 3 (three) pressure ulcer (full-thickness tissue loss) to the upper medial (toward middle or center) left buttock and the area was not measured. The wound bed had 50 percent slough (dead tissue, usually cream or yellow in color) and 50 percent granulation tissue and was acquired under care; - Pressure ulcer care was provided per the physician’s order (the physician order was for a Stage 2 pressure ulcer); and - The documentation failed to show physician notification of the acquired Stage 3 pressure ulcer to the upper medial left buttock, the 50 percent slough and 50 percent granulation tissue to the wound bed, and the severe lower back pain. (The nurse assessment on 08/18/2023 showed the pressure ulcer was on the left lateral buttock and there was no clarification if that was a new pressure ulcer or the Stage 2 on the left lateral buttock had worsened). Review of a skilled nurse assessment note, dated 08/29/2023, showed: - The patient had constant low back pain and rated it an eight (severe pain) and the aggravating factors were unknown; - A Stage 3 pressure ulcer to the left upper medial buttock, measured 6 cm length x 5.10 cm width. The wound bed had 30 percent slough and 70 percent granulation tissue and a small amount of serosanguineous drainage (the most common type of wound drainage secreted by an open wound in response to tissue damage); - Pressure ulcer care was provided per the physician’s order (the physician order was for a Stage 2 pressure ulcer); - “The patient will be starting a muscle relaxer, unsure of the name, and will update once it is received from the pharmacy”; - The assessment of the pressure ulcer on the left buttocks, showed an increase in size and depth (there was no documentation to show previous measurements of the Stage 3 pressure ulcer, the last measurement was on 08/18/2023 (eleven days prior) for the Stage 2 pressure ulcer on the left lateral buttock); - The patient stated the muscle relaxer would help him/her to be able to lay on his/her stomach so that he/she could stay off his/her buttocks more; and - The documentation failed to show physician notification of the Stage 3 pressure ulcer, the increased size of the pressure area, the serosanguineous drainage, the constant severe pain to the lower back, and clarification/verification of an order for a muscle relaxer. Review of the skilled nurse assessment note, dated 08/31/2023, showed: - The patient was currently being treated for an infection (the documentation failed to include the type of infection and if it was a new infection since the last nursing visit) and the wound assessment showed no current infection (the documentation failed to show an order for treatment of an infection); - The patient had constant shoulder pain and rated it a ten (severe pain) and the patient took baclofen (used to treat muscle spasms) that morning (no order for baclofen); - A Stage 3 pressure ulcer to the left lower lateral buttock, there was no measurements. The wound bed had 100 percent epithelialization (process where epithelial cells migrate upwards and repair the wounded area); - The patient had baclofen (the documentation failed to show a physician order) added to his/her medication and wound care was done per order (the physician order was for a Stage 2 pressure ulcer); and - The documentation failed to show physician notification of the Stage 3 pressure ulcer, new severe shoulder pain, that baclofen was added to his/her medication, and the patient was receiving treatment for an infection. Review of the skilled nurse assessment note, dated 09/05/2023, showed: - Constant back pain and rated it an eight (severe pain); - A Stage 3 pressure ulcer to the left lower buttocks, measured 6.3 cm length by 5.5 cm width, and a large amount of serosanguineous drainage (last assessment on 08/18/2023 (18 days prior) showed a Stage 2 pressure ulcer on the left lower buttocks which measured 3 cm length by 3 cm width by .20 cm depth); - Wound care was done per order (the physician order was for a Stage 2 pressure ulcer); - Wound assessment showed an increase in length and width (3.3 cm length increase and 2.5 cm width increase to the left lower buttock wound); and - The documentation failed to show physician notification of the Stage 3 pressure ulcer on the left lower buttocks, the increase in size, and the constant severe back pain. Review of the skilled nurse assessment note, dated 09/07/2023, showed: - Constant back pain and rated it an eight with intensity rated it a ten (hurts the worst); - A Stage 3 pressure ulcer to the left lower medial buttocks, the wound was not measured, and had a moderate amount of serosanguineous drainage; - Wound care done per physician’s order (the POC continued to show wound care orders for a Stage 2 pressure ulcer); - The nurse emphasized on the need for the patient to go to the wound clinic and the patient stated that he/she just needed medication and the wound would heal, the nurse let him/her know that the wound needed to be seen first before any prescription could be made; - The patient stated that he/she would show the wound to the physician during his/her appointment on 09/12/2023; and -The documentation failed to show physician notification of the Stage 3 pressure ulcer, the pain intensity of ten, and the need of a wound clinic appointment. Review of a missed visit fax form dated 09/14/2023, showed the patient was not seen per their frequency on the POC due to the patient had a physician appointment. Review of the skilled nurse assessment note, dated 09/15/2023, showed: - The patient was treated for a wound infection on the coccyx (a small triangular bone at the base of the spinal column) with doxycycline 100 mg (milligrams) (the documentation failed to show if this was a new pressure ulcer or the same as the left upper medial buttock pressure ulcer); - Constant back pain, rated it an eight, and an intensity of ten (hurts the worst); - Wound care was not done per the patient’s request, the patient stated his/her cousin had changed the dressing the day prior, the nurse offered to put on a new dressing and the patient declined; - The Stage 3 pressure ulcer was not assessed per the patient’s request; and - The POC continued to show treatment for a Stage 2 pressure ulcer. Review of the skilled nurse assessment, dated 09/19/2023, showed: - Constant pain to the back/buttocks, rated it a nine (severe pain), and hurt all over; - The patient had a high level of pain that day and had not taken anything for it; - An Unstageable pressure ulcer (an obscured full-thickness skin and tissue loss) to the left upper medial buttocks, measured 6 cm by 6 cm by 1.9 cm, with 20 percent slough, 20 percent granulation, and 60 percent eschar (dead skin that is usually dry, tough, leathery, and black in color, tightly attached to a wound bed, making it unable to be classified), and the surrounding skin had 1.5 cm granulation past wound depth, and moderate amount of serosanguineous drainage; - Assessment of the pressure ulcer on the left buttocks showed a 4 cm open wound that had a depth of 1.9 cm, there was little granulation and mostly slough and eschar; - The periwound (surrounding area of the wound edge) to the depth of the wound had granulation tissue and approximately 1.5 cm around the total wound; - Measurement given on the wound assessment was for the entire area where there was granulation tissue and the area where there was depth to the wound; - The physician was notified and a verbal order was received for the wound clinic (documentation failed to show what the physician was notified of); and - The documentation failed to show a treatment order for the unstageable pressure ulcer or any new interventions/medication changes for the patient’s high level of pain . Review of the skilled nurse assessment note, dated 09/22/2023, showed: - An Unstageable pressure ulcer to the left medial buttocks and it was not assessed; - The patient had diarrhea the day prior and was unsure if it was related to the antibiotic or not; - The patient stated the caregiver had changed the dressing the day before and declined wound care that day; and - The wound clinic was called, it was determined the patient did not want to go to that wound clinic and the nurse notified another wound clinic the patient agreed to, a message was left with the wound clinic to call the patient to set up an appointment as soon as possible. Review of the skilled nurse assessment note, dated 09/26/2023, showed: - An Unstageable pressure ulcer to the left upper medial buttocks and there was no assessment; - The patient had diminished lung sounds, wheezing, and a cough; - During the visit the patient became more pale, lethargic, and stated he/she did not feel well; and - The patient agreed to go to the emergency room, when the emergency medical technician arrived the pressure ulcer on buttocks was discussed and the possibility of an infection. During an interview on 11/13/2023 at 3:20 PM, the director of nursing (DON) stated that the primary care physician managed the patient’s care. He/she laid eyes on the wound in August of 2023. The patient had bilateral amputation and had difficulty going to the doctor. The patient had chronic pressure ulcers and was non-compliant with care. There was only one wound on the left buttock. On 08/24/2023, “things started going downhill”, the nurse was measuring the wound every Monday. He/she read the 08/29/2023 skilled visit note and the physician was not notified. During an interview on 11/14/2023 at 9:41 AM, LPN A stated that the patient’s physician should be notified when the pressure ulcer worsened. He/she kept talking to the patient about going to the wound clinic and he/she would refuse. He/she did not recall notifying the physician about the worsening of the wound. He/she left for vacation the same day the patient started an antibiotic (09/15/2023), when he/she returned from vacation (09/26/2023) the wound was bad enough to send the patient to the hospital. The patient always rated his/her pain a seven, eight, nine or ten that meant a one, two, three, or four. During an interview on 11/14/2023 at 2:47 PM, the administrator stated that the agency (provider) does not assess acceptable level of pain they do functional base score level, acceptable pain scores are derived from the patient’s pain that is acceptable for them and if the patient is not satisfied, the physician is notified. There was physician notification of the Stage 3 pressure ulcer on 09/12/2023 (19 days after the Stage 3 pressure ulcer was first identified 08/24/2023) and he/she had no further information. The nurse should have documented this in the nursing note. He/she would expect physician notification of any patient’s change in condition. During a telephone interview on 11/14/2023 at 9:38 AM, the patient stated that he/she had no complaints regarding the home health agency. They were the ones that called the ambulance. He/she was currently residing in a long-term care facility. He/she had no complaints of the care he/she received from the home health agency.”

“Org. had partial/extended survey CFR(s): 484.80(f)(3) Was subjected to an extended (or partially extended) survey as a result of having been found to have furnished substandard care (or for other reasons as determined by CMS or the state); or This Element is not met as evidenced by: Based on the results of this partially extended level survey, resulting in noncompliance with one Condition of Participation: Care planning, coordination of services, and quality of care, the home health provider may not train, or competency evaluate their home health aides for a period of two (2) years following the date of this survey. This restriction ends 11/25/2025.”