Every finding on record at John Knox Village

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 05/29/2025. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Providers.

A partial extended survey for Medicare recertification for the home health provider was completed on 05/29/2025. The provider had 237 current patients.

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.

A complaint investigation (101589) was completed on 11/15/2023 at the home health provider. The provider had a census of 287. The complaint is substantiated. One or more of the allegations reported are verified and deficiencies were cited that are related to the allegations being investigated. One condition level deficiency was identified during this survey at: -§484.60 Condition of Participation: Care planning, coordination of services, and quality of care. A home health agency that is found out of compliance with any Condition of Participation evaluated as part of a standard survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at 484.80(f) (3) - see Tag G788.

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.

The Emergency Preparedness regulations were reviewed as part of the Medicare recertification survey completed on 06/08/2022. During the survey it was determined the home health provider is in compliance with the requirements of 42 CFR 484.102 Condition of Participation: Emergency Preparedness for Home Health Agencies.

An extended survey for Medicare recertification for the home health was completed on 06/08/2022. The agency had 364 current patients. Two condition-level deficiencies were identified during this survey: - 484.55 Condition of Participation: Comprehensive assessment of patients; and - 484.60 Condition of Participation: Care planning, coordination of services, and quality care. A home health agency that is found out of compliance with certain Conditions of Participations evaluated as part of an extended survey may not train or competency evaluate their home health aides for a period of two (2) years following the date of this survey. A deficiency has been cited at 484.80(f) (3) - see Tag G788.

Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient's rights and responsibilities under this rule and the HHA's transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. This ELEMENT is not met as evidenced by: Based on review of the agency’s current patient right’s information included in the admission booklet, and interview, the agency failed to include the written notice of the patient rights, that include the patient’s right to have a copy of the patient’s rights and responsibilities, and the agency’s transfer and discharge policies provided to a patient-selected representative within four business days of the initial evaluation visit. This deficient practice has the potential to affect the knowledge and comprehension of the rights and responsibilities of all agency patients. Findings included: Review of the agency’s preprinted admission booklet, provided to the patients at the time of admission, showed on page 12, you have the right to be informed of and receive a copy of the agency’s transfer and discharge policy. The patient’s right information in the preprinted booklet failed to include within four business days of the initial evaluation. During an interview on 06/07/2022 at 11:41 AM the administrator stated that: - The four days isn’t in there; - Whatever we need to do. We will add it (within four business days of the initial evaluation visit); and - We thought that the company that publishes the book kept it up to date with the patient’s rights.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: Based on review of the agency’s patient rights information included in the admission booklet, policy review, and interview, the agency failed to assure that the patients be advised, orally and in writing, of the extent to which payment for HHA (home health agency) services may be expected. This deficient practice has the potential to affect the rights of all the agency patients. Findings included: Review of the agency’s preprinted admission booklet, provided to the patients at the time of admission, showed in section 4 (four), on page 13, you have the right to be advised of the extent to which payment for home health services may be expected from Medicare, Medicaid or any other federally-funded or federal aid program known to the HHA. It failed to include, “orally and in writing”. Review of the agency’s policy titled, “Patient Rights and Responsibilities” (policy number 1.001), dated most recently revised 12/7/21 showed: - Policy: Upon admission to home health, all patients will be provided with a booklet. The patient rights and responsibilities are in section IV (four) of the booklet; - Procedure: To be advised of their financial obligation, including but not limited to: * Charges for services that may or may not be covered; * Charges that they may be required to be paid before services are rendered; and * Any changes in the information regarding payment. The agency’s policy failed to include “orally and in writing”. During an interview on 06/07/2022 at 11:41 AM the administrator stated that: - On page 11 (eleven) it says Patient rights and responsibilities: Written rights must be provided during the initial evaluation visit before care begins. A verbal explanation of these rights may be provided at the same time or within a specified time frame; - On the admission consent form in the admission booklet it says I acknowledge verbal explanation and written receipt that I have been made aware of my rights and responsibilities as a patient (including OASIS (outcome and assessment information set) rights, agency administrator’s name and contact information, agency discharge, transfer and referral policy and how to contact local resources) and I understand them; - We will do whatever we need to do, we will add it (orally and in writing); and - We thought that the company that publishes the book kept it up to date with the patient’s rights.

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 policy review, record review, observation and interview, the agency failed to meet the requirements for the Condition of Participation: Comprehensive assessment of patients, when the agency failed to ensure: - The initial assessment visit must be held within 48 hours of referral or within 48 hours of the patient’s return home, or on the physician or allowed practitioner ordered start of care date (G514); - The comprehensive assessment must accurately reflect the patient’s status, including at a minimum, the patient’s current health, psychosocial, functional, and cognitive status (G528); and - The comprehensive assessment had a complete review of all medications the patient was currently taking including potential adverse effects and drug reactions, ineffective drug therapy, duplicate drug therapy, and noncompliance with drug therapy (G536). The cumulative effect of these systemic practices resulted in the agency’s inability to ensure that the patient’s healthcare needs would be met by the home health agency.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on policy review, record review, and interview, the agency failed to ensure an initial assessment visit was conducted to determine the immediate care and support needs of the patient within 48 hours of referral in two (Records/Patients #2 and #3) of 5 full records reviewed. This deficient practice has the potential to adversely affect identification of immediate care needs for all the agency’s patients. RECORD/PATIENT #2: Review of the clinical records showed: - Patient referred to home health services by the PCP (primary care provider) on 05/10/2022; - Skilled referral for PT (physical therapy); - Start of care visit made on 05/16/2022; - PT communication note for patient request of 05/16/2022 for start of care visit with physician notified; and - No physician order start of care date for 05/16/2022. During an interview on 06/07/2022 at 12:30 PM, the therapy manager reported: - Patient requested start of care for the following Monday (05/16/2022); and - Physical therapy entered the wrong date for the verbal order start of care date (05/23/2022). Findings included: Review of the agency’s policy titled, “Start of Care Assessment” (policy number 3.001), most recently revised 12/7/21 showed: - The initial home health visit will be a comprehensive patient assessment which includes the patient’s specific need for home care (including medical, nursing, rehabilitative and social services), eligibility for home care (including payor source and homebound status, if applicable), psychosocial needs, and discharge planning needs; - The SOC (start of care visit must be performed and documented in the patient’s electronic medical record (EMR) by a qualified clinician per the Centers for Medicare and Medicaid Services (CMS) guidelines; - The SOC visit must be performed either within 48 (forty eight) hours of the completed referral, within 48 hours of the patient’s return home, on the specific date order by the physician/allowed practitioner; and - The SOC may be delayed at the patient/family request with the approval of the physician and the receipt of an updated order. RECORD/PATIENT #2 Melissa RECORD/PATIENT #3 Review of a referral fax cover sheet from a local hospital showed: - An encounter date of 05/09/2022; and - A printed date of 5/12/2022 3:55 PM. Review of the OASIS (Outcome and Assessment Information set-a standardized assessment) showed: - Item M0030 SOC date: 05/19/2022 (72 hours after referral); - Item M0102 Date of physician ordered start of care marked N/A- no specific start of care date ordered by physician; - Item M0104 date of referral: 05/16/2022; and - Item M01005 Inpatient discharge date: 05/14/2022. Review of the clinical record failed to show a physician order approving a late SOC date. During an interview on 06/07/2022 at 10:40 AM the therapy manager stated that: - The completed referral was 05/16/2022 (after the admitting physician and insurance is all verified); - We should write a late SOC order; - Typically we let the physician know and obtain the order; and - I don’t see where the order was initiated.

Health, psychosocial, functional, cognition CFR(s): 484.55(c)(1) The patient's current health, psychosocial, functional, and cognitive status; This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, and interview, the agency failed to ensure the comprehensive assessment accurately reflected the patient’s current health status in two (Records/Patients #2, and #4) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency policy titled, “Start of Care Assessment,” revised 12/07/2021, showed, in part: - The SOC (start of care) assessment will include the Outcome and Assessment Information Set (OASIS) if required by the patient’s payor source; - This assessment will measure patient outcomes from data collected at the SOC and at the defined intervals as required by CMS; and - The SOC assessment must include, as a minimum, the patient’s current health status. RECORD/PATIENT #2: Review of the clinical record, showed, in part: - Patient referred to home health services by the primary care provider for general strengthening due to impairments resulting from a history of CVA (cerebrovascular accident which happens when there is a loss of blood flow to part of the brain and the brain cells cannot get the oxygen they need and start to die); - The SOC assessment visit was on 05/16/2022; and - The patient’s height and weight was listed as “not assessed” during the comprehensive assessment. During an interview on 06/07/2022 at 12:05 PM, the administrator reported the patient’s height and weight should be assessed at the SOC and no documentation found in the chart for why height and weight was not assessed. RECORD/PATIENT #4: Review of the clinical record, showed, in part: - Patient referred to home health services after hospitalization for a stroke (when the brain is deprived of oxygen and blood supply) due to intracerebral hemorrhage (bleeding within the brain tissue); - The SOC assessment visit was on 04/21/2022; - Narrative note from the comprehensive assessment on 04/21/2022 showed, the patient had cognitive impairment, was not completely tracking during visit, had difficulty finding his/her words, had confusion, forgetfulness, and was anxious at times; - The patient’s comprehensive assessment on 04/21/2022 for pain, showed: * "Yes" was answered to the question that asked if the patient ever has pain; * "No" was answered to the question asking if patient was experiencing pain; * "Yes" was answered to the question asking if patient is able to communicate pain; * No documentation noted on pain assessment for location, frequency, intensity, description, contributing factors, or pain relieving techniques; and * No documentation of non-verbal cues and/or signs or symptoms of pain for a patient with cognitive impairments that had difficulty "finding words" during assessment. During an interview on 06/08/2022 at 11:30 AM, the administrator and director of nursing acknowledged the findings and agreed that documentation should include if non-verbal cues and/or signs or symptoms of pain were present.

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, observation, and interview, the agency failed to perform 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 in three (Records/Patients #2, #3, and #5) of five full records reviewed. This deficient practice has the potential to adversely affect the medication management of all patients served by the agency. RECORD/PATIENT #2: Review of the clinical records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; - PMH (past medical history) of spasms with baclofen pump (implanted device that delivers a medication used to treat muscle spasms); - Medications on POC, included, but not limited to: * Baclofen (muscle relaxant) 10,000 mcg (micrograms)/20 ml (milliliters) (500mcg/ml) intrathecal solution (vial ml) 1 every one day intrathecal (occurring within or administered into the spinal canal) pump was listed on the medication list (Dose on medication list is the total volume of the medication that is in the pump but does not include daily infusion dose); * Lisinopril (reduce blood pressure) 10mg (milligram) tablet, take 1 tablet every day; * Tylenol extra strength 500mg (milligram) tablet with a quantity of “2” by mouth as needed for pain and a note, “instructed not to take more than 4000mg” (No dose frequency listed on medication list); and - Review of the PT discharge visit note on 06/01/2022 showed, patient utilizing icy hot (to help relieve minor aches and pains) topical ointment (not on POC). During home visit observation on 06/07/2022 at 1:20 PM, showed: - COTA (occupational therapy assistant) asked the patient if he/she had any medication changes since last visit and reviewed medication bottle for new Gabapentin (for nerve pain); - No other medication bottles were reviewed by COTA during medication reconciliation; - Surveyor reviewed medication bottles after the COTA finished medication reconciliation, and found baclofen 10mg tablets with instructions to take up to 3 tablets by mouth daily for "rescue use" only; - Spouse reported that baclofen tablets are for the patient to take in the event the baclofen pump starts alarming and stops delivery the medication; - Baclofen 10 mg tablets are not listed on the POC (no documentation to clarify “rescue use” instructions and/or orders with the physician; and - Lisinopril 10mg tablet, take 1 tablet two times daily (no documentation of clarification with physician on bottle instructions being different than what the patient is taking). During an interview on 06/08/2022 at 10:50 AM, the administrator reported the following: - The SOC clinician should be looking at the bottles during SOC visit; - Physician should be contacted for clarification of medication discrepancies; - Baclofen pump settings with daily infusion dose should be on POC; and - Baclofen 10mg tablets with rescue use orders should be on POC in the event the patient has pump issues. Findings included: Review of the agency’s policy titled, “Medication Management” (Policy number 4.017), dated most recently revised 3/29/22, showed in part: -Policy: Medication management includes establishing the patient medication profile at initial assessment, the ongoing monitoring and reconciliation, and patient adherence to the medication regimen; - Purpose: To define the initial medication profile, ongoing medication monitoring and reconciliation process for the patient, in accordance with the established POC (plan of care); - Procedure at SOC (start of care), ROC (resumption of care), and recertification: *Upon admission to the agency, the admitting clinician will initiate a medication profile to document the current medication regimen; *The initial medication profile will be sent to the patient/representative; *The admitting clinician will enter into the EMR (electronic medical record) all medications, including prescription and nonprescription, as well as times of medications and routes of administration. Medication includes nutritional supplements, vitamins and herbals, TPN (total parenteral nutrition), and oxygen; * As a standard best practice, medication bottles (when available) should be compared to the medication lists to complete the medication reconciliation; * The medication review will identify effectiveness, potential contraindications, omissions, dosage errors, drug/drug and drug/food interactions, duplicative drug therapy, clinically significant adverse reactions and/or side effects, and non-compliance with drug therapy; * Significant medication reconciliation issues or significant interactions identified by the admitting RN (Registered Nurse) will be reported to the physician responsible for the home health (HH) POC; * If the admitting clinician is a PT (physical therapist) or SLP (speech and language pathologist), the issue/interaction will be reported to the Director of Nursing or designee; * The admitting RN will enter a clinical note regarding med reconciliation, teaching, and resolution; and * IF the admitting clinician is a PT or SLP, the DON or designee will contact the patient to complete the medication management review and reconciliation. After completion, a clinical note will be placed in the EMR. - Ongoing monitoring and medication changes: * Medication review will occur at each visit; * Clinicians, as allowed by their scope of practice, will assess the effect of medications on the patient through direct observation during home visits, review of assessment information, as well as clinical results of diagnostic studies (when available); * The medication review process includes checking for the following: ** Effectiveness; **Potential contraindications; ** Omissions; **Dosage errors; **Drug/drug and drug/food interactions; **Duplicative drug therapy; **clinically significant adverse reactions and/or side effects; and **Noncompliance with drug therapy. * Completion of the medication review will be documented into the patient chart; * When medication changes occur, an updated medication profile will be sent to the patient/representative; * Review of the information gathered from the above activities will be shared by the clinician with appropriate physicians, as well as other agency clinicians involved in the care of the patient; * Any medication changes identified by non-nursing staff will be reported to the RN case manager/agency DON or designee; * An agency nurse will contact the patient’s physician to resolve any clinically significant medication issues found when any new medication(s) are added and document notification in the EMR; * Based on the medication review, changes in the POC may be required; and * For therapy only patients, medication education will be provided by the agency DON or designee. After a clinical note will be placed in the EMR. PATIENT/RECORD #2, Melissa RECORD/PATIENT #3 Review of the hospital discharge medication list instructions dated 05/14/2022 showed, in part: - Acetaminophen SR (sustained release) 650 mg (milligram) tablet, take 650mg by mouth daily as needed (Initial POC (plan of care) dated 05/19/2022 to 07/17/2022 showed 8hour pain reliever 650 mg tablet ER (extended release) 1-2 tablets twice daily as needed for pain; - Benzonatate 100mg capsule, take 1 capsule 3 times daily as need for cough (Initial POC dated 05/19/2022 to 07/17/2022 showed it failed to be listed); - Cyanocobalamine 1,000 mcg 1 tablet daily (Initial POC dated 05/19/2022 to 07/17/2022 showed 1,000 mcg/ml (microgram per milliliter), 1,000mcg IM (intramuscular) daily); - Epinepherine 1 mg/ml injection pen, inject 0.3mg into the muscle as needed (Initial POC dated 05/19/2022 to 07/17/2022 showed it failed to be listed); and - Therapeutic multivitamin, take 1 tablet by mouth (Initial POC dated 05/19/2022 to 07/17/2022 showed it failed to be listed). Review of SOC (start of care) OASIS (Outcome and Assessment Information Set- a standardized assessment) dated 05/19/2022, showed Item M2001 Drug Regimen Review: Did a complete drug regimen review identify potential clinically significant medication issues? Response was a 0. No – no issues found during drug regimen review. Review of the clinical record showed the agency failed to document communication with the physician regarding the medication discrepancies from the referral vs the initial POC. During an interview on 6/08/2022 at 10:04 AM the administrator stated that the 485 (initial plan of care) is considered the order for the medication discrepancies clarification. RECORD/PATIENT #5 Review of referral information showed: - A physician appointment note dated 12/27/2021 with current medications taking listed as: * Keflex 500mg capsule, one capsule orally four times per day (not noted on initial POC); * Diflucan 200mg one tablet orally (with no further directions) (not noted on initial POC); * Oxycodone HCL 5mg tablet, 1-2 tablets as needed orally every 4 hours as needed (Amount and frequency discrepancies on initial POC); * Nystatin 100000 u/gm (unit per gram) powder 1 application externally twice a day (not listed on initial POC); and * Medication list reviewed and reconciled with the patient. (There was no other medication list noted within the referral information) Further review of a physician appointment note, dated 12/27/2021, included within the referral information showed patient to start oxycodone-acetaminophen tablet 5-325mg 1 tablet every 4-6 hours as needed orally (dose discrepancy noted on initial POC). Review of the initial POC (plan of care) dated 01/05/2022-03/05/2022 showed the following medication discrepancies: - Amitriptyline 25mg (milligram) tablet 1 as needed oral as needed daily for sleep (not listed on referral information); - Hydrocodone 7.5-acetaminophen 1 as needed oral every 4 hours as needed for pain (dosage discrepancy noted on initial POC); - Lorazepam 2mg tablet 1 tablet three times daily oral (used to treat anxiety) (not listed on referral information); - Losartan 50mg tablet 1 every 1 day oral (used to treat high blood pressure) (not listed on referral information); - Mobic 15mg tablet 1 every 1 day oral (used to treat arthritis pain) (not listed on referral information); - Oxycodone 5mg capsule 1 as needed oral as needed every 6 hours for pain (narcotic pain medication) (amount and frequency discrepancies noted on initial POC); - Proair Digihaler 90mcg (microgram)/actuation aerosol powder breath act. sensor 2 puffs as needed inhalation every 4 hours as needed for SOA (short of air) (used to treat tightening of airways in the lungs) (not listed on the referral information); - Synthroid 137mcg tablet 1 every 1 day oral (replacement used when the thyroid gland doesn’t produce enough hormone) (not listed on referral information); - Triameterene 37.5mg – hydrochlorothiazide 25 mg capsule 1 every one day oral (used to treat fluid retention and high blood pressure) (not listed on the referral); - Tylenol extra strength arthritis pain 500mg tablet 1 as needed oral as needed every 6 hours for pain not to exceed 4 gr (grains) in 24 hours (not listed on referral information); - Vitamin B12 1,000 mcg-folic acid 400mcg sublingual lozenge 1 every one day oral (vitamin replacement) (not listed on referral information); - Voltaren 1% topical gel 2 gr as needed topical as needed up to twice daily for joint pain (not listed on referral information); and - Gabapentin 800mg tablet 1 two times daily oral (seizure medication used to treat nerve pain) (not listed on referral information). Review of SOC OASIS (Outcome and Assessment Information Set- a standardized assessment) dated 01/05/2022 showed Item M2001 Drug Regimen Review: Did a complete drug regimen review identify potential clinically significant medication issues? Response was a 0. No – no issues found during drug regimen review. Review of a communications clinical note dated 01/10/2022, signed by clinical support RN (registered nurse) showed: - Called and spoke to patient to review medications; - Medication profile reviewed and this nurse inquired if there were any medication changes or any other OTC (over the counter) or prescription medication; and - Patient denied any new medication or changes. Review of the clinical record showed the agency failed to document communication with the physician regarding the medication discrepancies from the referral vs the initial POC. During an interview on 6/08/2022 at 10:04 AM the administrator stated that the process for med reconciliation on admission for therapy only patients included: - The therapist looks at the list provided with the referral and the mediation bottles; - They add all the medications the patient is taking to the system; - The support nurse will call the patient and go through the mediations again and provide education and clarify doses and frequency; and - The 485 (initial plan of care) is considered the order for the medication discrepancies clarification.

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 agency failed to meet the requirements for the Condition of Participation: Care planning, coordination of services, and quality of care when the agency failed to ensure: - Each patient must receive an individualized written plan of care including, but not limited to, all medications and treatments (G574); - Each patient must receive an individualized written plan of care including, but not limited to, all patient care orders, including verbal orders, must be recorded in the plan of care (G576); - Services provided followed the plan of care as ordered by the physician (G580); - 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); - Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient (G604); - Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines (G606); and - Provide written information of the visit schedule, including frequency of visits by the HHA (home health agency) personnel and personnel acting on behalf of the HHA (G614). 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 agency.

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 review of the agency’s policy, clinical record review, home visit observation, and interview, the agency failed to ensure that each patient's written individualized plan of care (POC) included all required elements in two (Records/Patients #2 and #5) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #5 Review of an orthopedic clinic note dated 12/27/2021 showed, in part: - Referral to home health service after a six week follow up appointment on 12/27/2021 for post left THA (total hip arthroplasty- total hip replacement); - Patient was having pain in his/her right knee as well as mild pain in his/her left hip with motion; - Start oxycodone-acetaminophen tablet, 5-325 MG (Milligram), 1 tablet every 4-6 hours as needed (for pain); - Other current medications included oxycodone HCL(hydrochloric acid) 5 MG tablet 1-2 tablets as needed every 4 hours (for pain); - The physician plan from appointment: Due to the discomfort the patient is experiencing, the physician explained that there will be some discomfort between 6-10 weeks. The itchiness the patient was experiencing was discussed and for now he/she will monitor it and will discontinue the oxycodone if it persists. He/she will begin physical therapy for the left hip. Physical therapy was ordered to work on motion, strength and modalities as needed for 2-3 times per week for 4 weeks. His/her right knee pain was discussed. Review of the initial POC (plan of care) dated 1/05/2022 to 3/05/2022 showed: - Diagnoses of aftercare following joint replacement surgery, presence of left artificial hip, long term (current) use of opiate analgesic (narcotic pain medication), and long term (current) use of non-steroidal anti-inflammatory (medication used to reduce pain and inflammation); - Medications included, but not limited to: *Gabapentin 800 mg tablet, 1 three times daily (seizure medication also use to treat nerve pain); *Hydrocodone7.5 mg-acetaminophen 325 mg tablet (opioid pain medication), 1 as needed every 4 hours; * Oxycodone 5 mg capsule 1 as needed every 6 hours for pain (narcotic); * Tylenol extra strength arthritis 500 mg 1 as needed every 6 hours for pain not to exceed 4 gr (grain) in 24 hours; * Voltaren 1% topical gel 2 gr as needed topical up to twice a day for joint pain; and *Mobic 15 mg tablet 1 as needed daily for pain. - Orders for disciplines and treatments: PT (physical therapy) two times weekly for one week, three times weekly for two weeks, two times weekly for one week. PT evaluated, functional L/E (lower extremity- legs) and U/E (upper extremity- arms) ther ex (therapeutic exercise), gait/transfer/balance training, home ex (exercise), home safety and vitals including O2 (oxygen) sat (saturation) reporting - Goals/rehabilitation potential/discharge plans: Therapy- patient will demonstrate effective pain level of control by agency discharge. Review of visit notes report dated 01/05/2022 showed under care plan documentation (this is not sent to and signed by the physician) showed: - Outcome: Therapy- patient will demonstrate effective pain level of control by agency discharge. - Interventions: Therapy *Assess and monitor patient current level of pain (using standardized pain scale); *Assess pain level highs and lows since last therapy visit including the location and description of pain; *Assess/monitor and instruct patient/caregiver in alternative pain management techniques such as relaxation, distraction, massage, hot and cold packs and other modalities as indicated; *Assess/monitor/instruct patient satisfaction with current pain management regimen; and *Consult with physician or SN (skilled nurse) if patient’s pain is not controlled with current regimen. The initial POC failed to show patient-specific interventions including the need to monitor for pain or when to report pain to the physician or allowed practitioner, interventions to control pain as well as measurable outcomes and goals. During an interview on 06/08/2022 at 10:04 AM with the therapy manager he/she stated that: - He/she was unable to find where pain was being addressed on the initial POC; - It (pain) is being addressed on the care plan; and - It should have been on the 485 (physician’s signed and dated POC). Findings included: Review of the agency policy titled, “Care Planning Process,” revised 02/08/2022, showed, in part: - The patient and family/caregiver will participate in decisions regarding the POC whenever possible; - The following factors should be considered during the care planning process: * Individualized patient needs; * Monitoring effectiveness of medications, as appropriate; * Pain and symptom management, as appropriate; - The POC may include, but will not be limited to: * Individualized goals and interventions; * Specific services to be provided; * 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. RECORD/PATIENT #2: Review of the plan of care, dated, 05/16/2022 through 07/14/2022, showed: - Primary diagnosis of hemiplegia (paralysis of one side of the body) and hemiparesis (weakness of inability to move on one side of the body) following cerebral infarction (damage to tissues in the brain due to loss of oxygen to the area); - PMH (past medical history) of spasms with baclofen pump (implanted device that delivers a medication used to treat muscle spasms) placed 2/22 (February 2022); - Presence of other specified devices (baclofen pump); - Baclofen 10,000 mcg (micrograms)/20 ml (milliliters) (500mcg/ml) intrathecal solution (vial ml) 1 every one day intrathecal (occurring within or administered into the spinal canal) pump was listed on the medication list (Dose on medication list is the total volume of the medication that is in the pump but does not include daily infusion dose); - The patient goals section of the POC noted, “Patient will demonstrate effective level of pain control by agency discharge,” but no orders for treatments on POC related to pain; and - No reporting parameter, pain level goal, and/or physician managing baclofen pump listed on the POC. Review of the referral records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; - PMH of spasms with baclofen pump; - In February of 2022, the patient had intrathecal baclofen pump exchange for end of battery life; and - Patient is to follow up with (named physician) for ongoing management (for the baclofen pump). Review of the PT start of care evaluation visit note, on 05/16/2022, showed: - Patient rating current pain a 7 on a scale of 0-10 (0 being no pain and 10 being the worst pain); - Patient rated pain level at a 9 when pain was at the worst and a 1 when pain was at best; - Pain is described as, constant, all over, ache, and twitching; - Pain relieved by, medication management, repositioning, rest, ice, compression, and elevation; - Pain medication use is needed multiple times a day (no documentation for specific medication with dosage and frequency that was used multiple times a day); and - Physician notified of POC, frequency (of PT visits), requested MSW (medical social worker), OT (occupational therapy), and informed of patient’s report of acetaminophen (pain reliever) use (no documentation of pain being reported or what amount of acetaminophen the patient reported taking). Review of the PT discharge visit note, on 06/01/2022, showed: - Patient rating pain 3-6 out of 10; - Pain was constant; - Patient utilizing icy hot (topical ointment used to help relieve minor aches and pains); - Patient has decreased Tylenol (acetaminophen) intake (no documentation of dose and frequency it was decreased to); - No documentation of physician notified for orders to update POC to include icy hot; and - No documentation of physician notification for possible baclofen pump dosage adjustments. Review of the POC failed to show: - Orders for hot and/or cold packs; - Icy hot orders (no interventions and/or instructions for the patient to not use hot or cold packs on areas that icy hot is applied); - Patient specific pain goal or reporting parameters; - Baclofen pump settings and daily infusion dose; and - Physician providing ongoing management of baclofen pump. During home visit observation on 06/07/2022 at 1:20 PM, showed: - The patient had a follow up appointment with the primary care provider regarding medication adjustments; - Physician ordered patient to start taking Gabapentin (used to treat nerve pain); - COTA (occupational therapy assistant) asked the patient if he/she had any medication changes since last visit and reviewed medication bottle for new Gabapentin; - No other medication bottles were reviewed by COTA during medication reconciliation; - Surveyor reviewed medication bottles after the COTA finished medication reconciliation, and found baclofen 10mg tablets with instructions to take up to 3 tablets by mouth daily for rescue use only; - Spouse reported that baclofen tablets are for the patient to take in the event the baclofen pump starts alarming and stops delivery the medication; and - Baclofen 10 mg tablets are not listed on the POC (no documentation to clarify “rescue use” instructions and/or orders with the physician. During an interview on 06/08/2022 at 10:50 AM, the administrator reported the following: - The physician that is providing ongoing management of the baclofen pump should be on the POC; - Physician should be notified of pain for possible dose increase to baclofen pump; - No documentation of physician being notified of pain; - Baclofen pump settings with daily infusion dose should be on POC; - Physician was informed of excessive Tylenol consumption reported by the patient during SOC visit but no documentation of physician being notified of pain and/or pain rated 7 out of 10; and - Baclofen 10mg tablets with rescue use orders should be on POC in the event the patient has pump issues.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, and interview, the agency failed to ensure that all patient care orders were included in the plan of care in two (Records/Patients #2 and #4) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, “Start of Care Assessment,” revised 12/07/2021, showed, in part: - The initial home health visit will be a comprehensive patient assessment which includes the patient’s specific need for home care; - The SOC (start of care) clinician will conduct a review and reconciliation of current medication use, including prescription, over the counter medications and herbal medications per medication management policy; - The individualized plan of care (POC) will be developed from the information gathered during the SOC assessment; and - The SOC clinician will reach out to the physician or other allowed practitioner for approval of orders and goals. Review of the agency's policy titled, “Care Planning Process,” revised 02/08/2022, showed, in part: - The plan of care should be initiated at start of care; - The following factors should be considered during the care planning process: * Monitoring effectiveness of medications, as appropriate; * Pain and symptom management, as appropriate; - The POC may include, but will not be limited to: * Individualized goals and interventions; * Specific services to be provided; 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. RECORD/PATIENT #2: Review of the clinical records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; - PMH (past medical history) of spasms with baclofen pump (implanted device that delivers a medication used to treat muscle spasms); - POC had Baclofen 10,000 mcg (micrograms)/20 ml (milliliters) (500mcg/ml) intrathecal solution (vial ml) 1 every one day intrathecal (occurring within or administered into the spinal canal) pump was listed on the medication list (Dose on medication list is the total volume of the medication that is in the pump but does not include daily infusion dose); - Referral record showed, the patient is to follow up with (named physician) for ongoing management (for the baclofen pump); - Review of the PT start of care evaluation visit note on 05/16/2022, showed, pain relieved by medication management, repositioning, rest, ice, compression, and elevation (not on POC); and - Review of the PT discharge visit note on 06/01/2022, showed, patient utilizing icy hot (topical ointment used to help relieve minor aches and pains). During home visit observation on 06/07/2022 at 1:20 PM, showed: - The patient had a follow up appointment with the primary care provider regarding medication adjustments; - Physician ordered patient to start taking Gabapentin (used to treat nerve pain); - COTA (occupational therapy assistant) asked the patient if he/she had any medication changes since last visit and reviewed medication bottle for new Gabapentin; - No other medication bottles were reviewed by COTA during medication reconciliation; - Surveyor reviewed medication bottles after the COTA finished medication reconciliation, and found baclofen 10mg tablets with instructions to take up to 3 tablets by mouth daily for "rescue use" only; - Spouse reported that baclofen tablets are for the patient to take in the event the baclofen pump starts alarming and stops delivery the medication; and - Baclofen 10 mg tablets are not listed on the POC (no documentation to clarify “rescue use” instructions and/or orders with the physician. Review of the POC failed to show: - Orders for hot and/or cold packs; - Icy hot orders (no interventions and/or instructions for the patient to not use hot or cold packs on areas that icy hot is applied); - Baclofen pump settings and daily infusion dose; and - Physician providing ongoing management of baclofen pump. During an interview on 06/08/2022 at 10:50 AM, the administrator reported the following: - The physician that is providing ongoing management of the baclofen pump should be on the POC; - Baclofen pump settings with daily infusion dose should be on POC; and - Baclofen 10mg tablets with rescue use orders should be on POC in the event the patient has pump issues. RECORD/PATIENT #4: Review of the referral orders showed: - Patient was referred to home health services with primary diagnosis of stroke (damage to the brain from interruption of blood its supply) due to intracerebral hemorrhage (a ruptured blood vessel causes bleeding inside the brain); - Disciplines ordered: RN (registered nurse), PT, OT (occupational therapy), and ST (speech therapy); - Please draw BMP (basic metabolic panel lab is a group of 8 tests that measures several substances in the blood) twice weekly with first draw on May 22, 2022 and fax results to the primary care provider (No documentation of communication with physician to clarify if BMP lab order was to start 04/22/2022 rather than 05/22/2022 due to acute hyperkalemia (high levels of potassium in the blood) with medication ordered to lower potassium level in the blood; - Medications: * Levetiracetam (used to treat seizures) 250 mg (milligrams) tablet take one tablet by mouth twice daily; * Melatonin (supplement to help with sleep) 1 mg tablet take one tablet by mouth at bedtime; * Senna/Docusate (treats constipation) 8.6mg/50mg tablet, take two tablets by mouth twice daily; * Sodium Zirconium Cyclosilicate (reduces high levels of potassium in the blood) 10 gram packet, take one packet by mouth daily. Mix entire contents of packet with 45ml (milliliters) of water, stir well, and administer immediately. Administer other oral medications 2 hours before or after dose; * Tamsulosin (used to treat urinary retention) 0.4mg capsule, take one capsule by mouth at bedtime; and - Start of care within 24-48 hours of hospital discharge, anticipated discharge 04/20/2022. Review of the SOC (start of care) visit note on 04/21/2022, showed: - SN (skilled nurse) recommendation for POC, included, but not limited to; May use agency vital sign parameters, check oxygen saturation each visit, SN frequency of 1w1, 2w2 (1 time a week for 1 week and 2 times a week for 2 weeks) with PT, OT, and ST, to evaluate and treat; - Patient/Caregiver instructions included; SN to check vital signs, listen to heart and lungs and monitor condition, draw labs as ordered, and therapy to help with strengthening and home exercise program; - Patient was educated on low potassium diet and use of Miralax to prevent constipation (No orders for Miralax in referral orders); and - Medications were reviewed and “all were present” with no severe medication to medication interactions (No documentation of communication with the physician to clarify medications listed in referral orders but not on POC. Review of the clinical records showed: - Documentation during hospitalization noted, acute hypertension and neurology goal for the patient’s BP (blood pressure) to stay below 140 (measures the pressure in the arteries when the heat beats); - Patient followed by neurology team with a future appointment scheduled for 01/06/2023 at 11:00 AM; and - Primary care provider was the only physician listed on POC. Review of the POC dated, 04/21/2022 to 06/19/2022, failed to show: - Melatonin (supplement to help with sleep) 1 mg tablet take one tablet by mouth at bedtime; - Senna/Docusate (treats constipation) 8.6mg/50mg tablet, take two tablets by mouth twice daily; - Sodium Zirconium Cyclosilicate (reduces high levels of potassium in the blood) 10 gram packet, take one packet by mouth daily. Mix entire contents of packet with 45ml (milliliters) of water, stir well, and administer immediately. Administer other oral medications 2 hours before or after dose; - BMP lab orders; - Patient’s neurologist; and - Blood pressure to be reported for systolic blood pressure (the pressure in the arteries when the heart beats) above 160 (No documentation of clarification for reporting parameter with neurology wanting blood pressure below 140 during hospitalization. During an interview on 06/08/2022 at 10:50 AM, the administrator reported: - The clinician should be looking at the medication bottles during the SOC visit; - Physician’s should be notified for clarification of medication discrepancies if medications differ from the referral orders; and - Patient’s neurologist should be on POC. During an interview on 06/08/2022 at 11:30 AM, the director of nursing reported the following: - No documentation of medication clarification noted; - No documentation of BMP lab order clarification; and - Will check on labs and medication prescribed to lower potassium level. During an interview on 06/08/2022 at 2:10 PM, the director of nursing reported the following: - Documentation from the hospital was obtained and had BMP lab order to begin on Friday April 22nd, 2022 (May 22nd, 2022 was a typo); - PCP (primary care provider) office contacted and patient had BMP lab drawn on 04/22/2022 from PCP (copy obtained); and - Potassium was within normal limits on 04/22/2022. During an interview on 06/08/2022 at 2:10 PM, the director of nursing reported: - The RN that completed SOC visit received a corrective action regarding SOC issues; - The agency discovered issues with the SOC visits missing information, including, orders not being entered, visits being missed, and labs not being drawn due to missed visits; and - Written counseling plan occurred on 05/17/2022 (copy provided).

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 agency policy review, clinical record review, and interview, the agency failed to ensure services and treatments were administered only as ordered by a physician in two (Records/Patients #2 and #5) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. PATIENT/RECORD #5 Review of the initial POC (plan of care) dated 1/05/2022 to 3/05/2022 showed: - Diagnoses of aftercare following joint replacement surgery, presence of left artificial hip, long term (current) use of opiate analgesic (narcotic pain medication), and long term (current) use of non-steroidal anti-inflammatory (medication used to reduce pain and inflammation); - Medications included, but not limited to: *Gabapentin 800 mg tablet, 1 three times daily (seizure medication also use to treat nerve pain); *Hydrocodone7.5 mg-acetaminophen 325 mg tablet (opioid pain medication), 1 as needed every 4 hours; * Oxycodone 5 mg capsule 1 as needed every 6 hours for pain (narcotic); * Tylenol extra strength arthritis 500 mg 1 as needed every 6 hours for pain not to exceed 4 gr (grain) in 24 hours; * Voltaren 1% topical gel 2 gr as needed topical up to twice a day for joint pain; and *Mobic 15 mg tablet 1 as needed daily for pain. - Orders for disciplines and treatments: PT (physical therapy) two times weekly for one week, three times weekly for two weeks, two times weekly for one week. PT evaluated, functional L/E (lower extremity- legs) and U/E (upper extremity- arms) ther ex (therapeutic exercise), gait/transfer/balance training, home ex (exercise), home safety and vitals including O2 (oxygen) sat (saturation) reporting - Goals/rehabilitation potential/discharge plans: Therapy- patient will demonstrate effective pain level of control by agency discharge. Review of visit note reports, including but not limited to, dated 01/05/2022, 01/10/2022, and 01/12/2022 showed encouraged hot/cold packs prn (as needed). Further review of the clinical record failed to show any orders for hot or cold packs. During an interview on 06/08/2022 at 10:15 AM the therapy manager stated that the care plan documentation has use of hot/cold packs and other modalities as indicated. He/she was unable to locate a physician order for the use of hot/cold packs. Findings included: Review of the agency’s policy titled, “Care Planning Process,” revised 02/08/2022, showed, in part: - All disciplines involved in the patient’s care will contribute to the POC (plan of care); - The following factors should be considered during the care planning process: * Individualized patient needs; * Monitoring effectiveness of medications, as appropriate; * Pain and symptom management, as appropriate; - The POC may include, but will not be limited to: * Individualized goals and interventions; * Specific services to be provided; * 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. RECORD/PATIENT #2: Review of the referral records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; - PMH of spasms with baclofen pump; - In February of 2022, the patient had intrathecal (occurring within or administered into the spinal canal) baclofen pump (implanted device that delivers a medication used to treat muscle spasms) exchange for end of battery life; and - Patient is to follow up with (named physician) for ongoing management (for the baclofen pump). Review of the clinical record showed: - PT start of care evaluation on 05/16/2022 noted, pain relieved by medication management, repositioning, rest, ice, compression, elevation, and pain medication use is needed multiple times a day; - Tylenol extra strength 500mg (milligram) tablet listed on POC with a quantity of “2” by mouth as needed for pain and a note, “instructed not to take more than 4000mg” (No dose frequency listed on medication list); - Physician notified on 05/16/2022 of POC, frequency, requested MSW (medical social worker) and OT (occupational therapy), and informed of patient’s report of acetaminophen (Tylenol to relieve pain) use (no documentation of pain being reported or what amount and frequency of acetaminophen the patient reported taking); - PT discharge visit note on 06/01/2022 showed: * Patient utilizing icy hot (topical ointment used to help relieve minor aches and pains); * Patient has decreased Tylenol (acetaminophen) intake (No documentation of how much patient was taking or is supposed to be taking other than for patient not to exceed 4000mg in a day); and * No documentation of physician notified for orders to update POC to include icy hot. During home visit observation on 06/07/2022 at 1:20 PM, showed: - The patient reported using icy hot to left leg (Not on POC); - Surveyor reviewed medication bottles after the COTA finished completing medication reconciliation, and found baclofen 10mg tablets with instructions to take up to 3 tablets by mouth daily for rescue use only (COTA did not review all medication bottles during visit and compare the bottles to the medication list); - Spouse reported that baclofen tablets are for the patient to take in the event the baclofen pump starts alarming and stops delivery the medication; and - Baclofen 10 mg tablets are not listed on the POC (no documentation to clarify “rescue use” instructions and/or orders with the physician. Review of the POC failed to show: - Orders for hot and/or cold packs; - Icy hot orders (no interventions and/or instructions for the patient to not use hot or cold packs on areas that icy hot is applied); - Baclofen pump settings with daily infusion dose; - Baclofen 10 mg tablets for rescue use; and - No orders for Tylenol frequency. During an interview on 06/08/2022 at 10:50 AM, the administrator acknowledged the findings and reported the following: - Baclofen pump settings with daily infusion dose should be on POC; - Physician was informed of excessive Tylenol consumption reported by the patient during SOC visit but no documentation of amount; and - Baclofen 10mg tablets with rescue use orders should be on POC in the event the patient has pump issues.

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 agency policy review, record review, observation, and interview, the agency 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 two (Records/Patients #2 and #5) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #5: Review of the initial POC (plan of care) dated 1/05/2022 to 3/05/2022 showed: - Diagnoses of aftercare following joint replacement surgery, presence of left artificial hip, long term (current) use of opiate analgesic (narcotic pain medication), and long term (current) use of non-steroidal anti-inflammatory (medication used to reduce pain and inflammation); - Medications included, but not limited to: *Gabapentin 800 mg tablet, 1 three times daily (seizure medication also use to treat nerve pain); *Hydrocodone7.5 mg-acetaminophen 325 mg tablet (opioid pain medication), 1 as needed every 4 hours; * Oxycodone 5 mg capsule 1 as needed every 6 hours for pain (narcotic); * Tylenol extra strength arthritis 500 mg 1 as needed every 6 hours for pain not to exceed 4 gr (grain) in 24 hours; * Voltaren 1% topical gel 2 gr as needed topical up to twice a day for joint pain; and *Mobic 15 mg tablet 1 as needed daily for pain The initial POC failed to include the need to monitor for pain or any parameters of when to report pain to the physician. Review of visit notes report dated 01/07/2022 showed under care plan documentation (which is not sent to physician or allowed practitioner for approval) dated 1/5/2022 showed: - Outcome: Therapy- patient will demonstrate effective pain level of control by agency discharge. - Interventions: Therapy *Assess and monitor patient current level of pain (using standardized pain scale); *Assess pain level highs and lows since last therapy visit including the location and description of pain; *Assess/monitor and instruct patient/caregiver in alternative pain management techniques such as relaxation, distraction, massage, hot and cold packs and other modalities as indicated; *Assess/monitor/instruct patient satisfaction with current pain management regimen; and *Consult with physician or SN (skilled nurse) if patient’s pain is not controlled with current regimen. Review of the SOC OASIS dated 01/05/2022, (Outcome and Assessment Information Set- a standardized assessment tool) showed: - Does the patient ever have pain? Yes; - Is the patient experiencing pain? Left blank; - Is the patient able to communicate? Left blank; - Patient exhibits the following nonverbal cues: restlessness; - Pain assessment Site 1: right knee, frequency-intermittent, current level (0-10): 4, worse pain gets (0-10): 8, best pain gets (0-10): 0, increases with activity: yes, description: ache, contributing factors: left blank, relieved by: medication management, relaxation and repositioning, other- Norco as needed every 6 hours, - Pain assessment Site 2: All was left blank; and - How often is medication needed? At least daily; - Is the patient satisfied with pain control? Yes; and - Frequency of pain interfering with patient’s activity or movement: Daily, but not constantly. Review of, but not limited to, visit notes report dated 01/07/2022 showed under pain assessment: - Has the patient experienced pain since the last skilled nursing visit? Yes; - Is the patient currently experiencing pain? (Including today’s visit) Yes; - Intensity using scale- 7, followed by a sad face and the number 8- hurts a whole lot; - Pain assessment Site 1: right knee, frequency-left blank, current level (0-10): 7, worse pain gets (0-10): left blank, best pain gets (0-10): left blank, increases with activity: yes, description: sharp and achy, pain on the inside and down the shin, contributing factors: LTHR (left total hip replacement), relieved by: cold compresses, medication management, warm compresses, other: blank; - Pain assessment Site 2: left hip, frequency-left blank, current level (0-10): 3, worse pain gets (0-10): left blank, best pain gets (0-10): left blank, increases with activity: no, description: sore and achy, contributing factors: previous surgery, relieved by: cold compresses, medication management, warm compresses, other: blank; - How often is medication needed? Left blank; and - Is the patient satisfied with pain control? Left blank Review of visit notes report dated 01/07/2022 showed under care plan documentation: - Patient reported his/her right knee was having sharp and achy pain 7-8/10. He/she noted left hip was achy but not too bad 2-3/10; - Educated patient on icwe (possibly a typo meaning ice) to reduce pain in left hip and frequent movement; and - Intervention listed: Therapy assess/monitor/instruct satisfaction with current pain management regimen, consult physician or SN if patient’s pain is not controlled with current regimen- status-not performed; and - The visit note failed to include physician notification of the pain rated at 7-8. During an interview on 06/07/2022 at 12:05 PM the administrator stated that pain is reported to the physician based on clinical judgement. During an interview on 6/08/2022 at 10:04 AM the administrator stated that the agency does get a baseline on admission and report if it is higher than the baseline. Findings included: Review of the agency policy titled, “Care Coordination and Ongoing Communication,” revised 08/24/2021, showed, in part: - All associates assigned to a patient’s care will be responsible for coordinating services provided; - The Case Manager will be responsible for the coordination between service providers, including, but not limited to: * Understanding of each team member’s responsibility in providing care; * Initiation of communication with other team members when there are significant changes in the patient’s overall care; - It will be the responsibility of every clinician caring for the patient to facilitate communication about changes in the patient’s status between the physician, other clinicians, and the case manager; - Documentation of all communication will be included in the electronic medical record (EMR); and - Written evidence of care coordination will be found in the patient’s EMR. RECORD/PATIENT #2: Review of the plan of care (POC) dated, 05/16/2022 through 07/14/2022 showed: - Primary diagnosis of hemiplegia (paralysis of one side of the body) and hemiparesis (weakness of inability to move on one side of the body) following cerebral infarction (damage to tissues in the brain due to loss of oxygen to the area); - PMH (past medical history) of spasms with baclofen pump (implanted device that delivers a medication used to treat muscle spasms) placed 2/22 (February 2022); - Presence of other specified devices (baclofen pump); - Baclofen 10,000 mcg (micrograms)/20 ml (milliliters) (500mcg/ml) intrathecal solution (vial ml) 1 every one day intrathecal (occurring within or administered into the spinal canal) pump was listed on the medication list (Dose on medication list is the total volume of the medication that is in the pump but does not include daily infusion dose); - The patient goals section of the POC noted, “Patient will demonstrate effective level of pain control by agency discharge,” but no orders for treatments on POC related to pain; and - No reporting parameter, pain level goal, and/or physician managing baclofen pump listed on the POC. Review of the referral records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; - PMH of spasms with baclofen pump; - In February of 2022, the patient had intrathecal baclofen pump exchange for end of battery life; and - Patient is to follow up with (named physician) for ongoing management (for the baclofen pump). Review of the PT start of care evaluation on 05/16/2022 showed: - Patient rating current pain a 7 on a scale of 0-10 (0 being no pain and 10 being the worst pain); - Patient rated pain level at a 9 when pain is at the worst and a 1 when pain is at best; - Pain is described as constant, all over, ache, and twitching; - Pain relieved by medication management, repositioning, rest, ice, compression, and elevation; - Pain medication use is needed multiple times a day (no documentation for specific medication and dosage used multiple times a day); and - Physician notified of POC, frequency, requested MSW (medical social worker) and OT (occupational therapy), and informed of patient’s report of acetaminophen (pain reliever) use (no documentation of pain being reported or what amount of acetaminophen the patient reported taking). Review of the PT discharge visit note on 06/01/2022 showed: - Patient rating pain 3-6 out of 10; - Pain was constant; - Patient utilizing icy hot (topical ointment used to help relieve minor aches and pains); - Patient has decreased Tylenol (acetaminophen) intake; - No documentation of physician notified for orders to update POC to include icy hot; and - No documentation of physician notification for possible baclofen pump dosage adjustments. During home visit observation on 06/07/2022 at 1:20 PM, showed: - Surveyor reviewed medication bottles after the COTA finished medication reconciliation, and found baclofen 10mg tablets with instructions to take up to 3 tablets by mouth daily for rescue use only; - Spouse reported that baclofen tablets are for the patient to take in the event the baclofen pump starts alarming and stops delivery the medication; and - Baclofen 10 mg tablets are not listed on the POC (no documentation of physician notification to clarify “rescue use” instructions and/or orders with the physician). During an interview on 06/07/2022 at 12:05 PM, when asked about reporting parameters not being on the POC, the administrator reported: - Pain is not reported to the physician based on parameters; and - Pain is reported to the physician based on clinical judgment. During an interview on 06/08/2022 at 10:50 AM, the administrator reported the following: - Physician should be notified of pain for possible dose increase to baclofen pump; - No documentation of physician being notified of pain; - Physician was informed of excessive Tylenol consumption reported by the patient during SOC visit but no documentation of physician being notified of pain and/or pain rated 7 out of 10; and - Baclofen 10mg tablets with rescue use orders should be on POC in the event the patient has pump issues.

Integrate all orders CFR(s): 484.60(d)(2) Integrate orders from all physicians or allowed practitioners involved in the plan of care to assure the coordination of all services and interventions provided to the patient. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, and interview, the agency failed to integrate orders from all physicians involved, to assure coordination of all services and interventions provided to the patient in two (Records/Patients #2 and #4) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, “Care Coordination and Ongoing Communication,” revised 08/24/2021, showed, in part: - All associates, assigned to a patient’s care, will be responsible for coordinating services provided; - It will be the responsibility of every clinician caring for the patient to facilitate communication about changes in the patient’s status between the physician, other clinicians, and the case manager; - Examples of reasons the physician will be contacted, include, but are not limited to: * Changes in the patient’s expected response to treatment or medications; * To complete medication reconciliation; * Problems implementing the plan of care; * Following an admission to establish a plan of care when indicated; and - Documentation of all communications will be included in the electronic medical record. RECORD/PATIENT #2: Review of the clinical record showed: - Plan of care (POC) dated, 05/16/2022 through 07/14/2022 showed: * PMH (past medical history) of spasms with baclofen pump (implanted device that delivers a medication used to treat muscle spasms) placed 2/22 (February 2022); * Presence of other specified devices (baclofen pump); * Baclofen 10,000 mcg (micrograms)/20 ml (milliliters) (500mcg/ml) intrathecal solution (vial ml) 1 every one day intrathecal (occurring within or administered into the spinal canal) pump was listed on the medication list (Dose on medication list is the total volume of the medication that is in the pump but does not include daily infusion dose); * The patient goals section of the POC noted, “Patient will demonstrate effective level of pain control by agency discharge,” but no orders for treatments on POC related to pain; - Review of the referral records showed: * PMH of spasms with baclofen pump; * Patient is to follow up with (named physician) for ongoing management (for the baclofen pump); and - Physician managing baclofen pump not listed on the POC. During an interview on 06/08/2022 at 10:50 AM, the administrator reported the following: - The physician that is providing ongoing management of the baclofen pump should be on the POC; - Physician should be notified of pain for possible dose increase to baclofen pump; and - No documentation of physician being notified of pain. RECORD/PATIENT #4: Review of the clinical records showed: - Patient was referred to home health services with primary diagnosis of stroke (damage to the brain from interruption of blood its supply) due to intracerebral hemorrhage (a ruptured blood vessel causes bleeding inside the brain); - Documentation during hospitalization noted, acute hypertension and neurology goal for the patient’s BP (blood pressure) to stay below 140 (systolic blood pressure is the pressure in the arteries when the heart beats); - Patient followed by neurology team with a future appointment scheduled for January 6, 2023 at 11:00 AM; and - Primary care provider was the only physician listed on POC. During an interview on 06/08/2022 at 10:50 AM, the administrator reported, the patient’s neurologist should be on the POC.

Integrate all services CFR(s): 484.60(d)(3) Integrate services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines. This ELEMENT is not met as evidenced by: Based on agency policy review, clinical record review, and interview, the agency failed to integrate services, to assure the identification of patient needs and factors that could affect patient safety and treatment effectiveness and the coordination of care provided by all disciplines in one (Record/Patient #2) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, “Care Coordination and Ongoing Communication,” revised 08/24/2021, showed, in part: - All associates, assigned to a patient’s care, will be responsible for coordinating services provided; - It will be the responsibility of every clinician caring for the patient to facilitate communication about changes in the patient’s status between the physician, other clinicians, and the case manager; - Based on communication with the physician, a verbal order will be obtained for any changes to the plan of care and communicated to all appropriate team members to ensure care is provided according to the revised plan of care; - When patients require more than one service from the agency, the case manager is responsible for cooperative care planning to ensure goals and actions are not duplicated and supportive inter-relationship of services; and - Documentation of all communications will be included in the electronic medical record. RECORD/PATIENT #2: Review of the clinical records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; - PMH (past medical history) of spasms with baclofen pump; - POC had Baclofen 10,000 mcg (micrograms)/20 ml (milliliters) (500mcg/ml) intrathecal solution (vial ml) 1 every one day intrathecal (occurring within or administered into the spinal canal) pump was listed on the medication list (Dose on medication list is the total volume of the medication that is in the pump but does not include daily infusion dose); - Referral record showed, the patient is to follow up with (named physician) for ongoing management (for the baclofen pump); - Review of the PT start of care evaluation visit note, on 05/16/2022, showed, pain rated 7 out of 10 (0 being no pain and 10 being the worst pain), pain relieved by medication management, repositioning, rest, ice, compression, and elevation (not on POC); - Review of the PT visit note, on 05/24/2022, showed, pain 7 out of 10, patient instructed in alternative pain management techniques such as relaxation, distraction, massage, hot and cold packs, and other modalities as indicted; - Review of the PT visit note on 05/26/2022 showed, pain 7 out of 10, pain relieved by Tylenol, repositioning, and relaxation; - Review of the PT discharge visit note on 06/01/2022 showed, patient utilizing icy hot (topical ointment used to help relieve minor aches and pains); and - No documentation of physician or SN being consulted for patient’s pain not controlled with current regimen. Observation on 06/07/2022 at 1:20 PM, during the patient's home visit, showed: - The patient had a follow up appointment with the primary care provider regarding medication adjustments; - Physician ordered patient to start taking Gabapentin (used to treat nerve pain); - COTA (occupational therapy assistant) asked the patient if he/she had any medication changes since last visit and reviewed medication bottle for new Gabapentin; - No other medication bottles were reviewed by COTA during medication reconciliation; - Surveyor reviewed medication bottles after the COTA finished medication reconciliation, and found baclofen 10mg tablets with instructions to take up to 3 tablets by mouth daily for rescue use only; - Spouse reported that baclofen tablets are for the patient to take in the event the baclofen pump starts alarming and stops delivery the medication; and - Baclofen 10 mg tablets are not listed on the POC (no documentation to clarify “rescue use” instructions and/or orders with the physician. During an interview on 06/08/2022 at 10:50 AM, the administrator reported the following: - The SOC clinician should be looking at the medication bottles during SOC visit; - Physician should be contacted regarding medication discrepancies; - Baclofen 10mg tablets with rescue use orders should be on POC in the event the patient has pump issues; - SN contacted patient and spoke with spouse over the phone regarding medications; and - No SN visits made because patient was a therapy only patient and PT did the SOC visit.

Visit schedule CFR(s): 484.60(e)(1) Visit schedule, including frequency of visits by HHA personnel and personnel acting on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on the review of patient rights in the agency’s admission booklet, home visit observation, and interview, the agency failed to provide patient's with written information for visit schedules, including frequency of visits by HHA (home health agency) personnel in three (Records/Patients #1, #2, and #4) of five full records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency’s admission booklet in the patient rights and responsibilities section, showed, in part: - We must provide these rights and responsibilities to you and/or your legal representative in a way you can understand; - Written rights must be provided during the initial evaluation visit before care begins; - You have the right to; * The care to be furnished, based on the comprehensive assessment; * The disciplines that will furnish the care; * The frequency of visits; and - Receive all services outlined in the plan of care. RECORD/PATIENT #1: Review of the clinical records showed: - Patient was referred to home health services following hospitalization for acute diverticulitis (inflammation or infection in one or more small pouches in the digestive tract) with pneumoperitoneum (air or gas in the abdominal cavity) resulting in Hartmann’s procedure (surgical procedure of the colon with closure of the rectum and redirecting the remaining colon to a colostomy), appendectomy (surgical operation to remove the appendix), and release of SBO (small bowel obstruction), with LLQ (left lower quadrant) colostomy (piece of the colon is surgically diverted to an artificial opening in the abdominal wall for excretion of bowel movement); and - Discipline visit frequency included, SN (skilled nurse) 2w2, 1w2 (2 times a week for 2 weeks and 1 time a week for 2 weeks). During home visit observation on 06/06/2022 at 2:15 PM, showed: - Skilled nurse visit to discharge patient from home health services; - Patient reported being unaware that SN would not be making one more visit; - POC (plan of care) showed the patient to be on week 5 with 1 more week of services (patient not due for discharge until following week); - Patient requested one more SN visit before being discharged; - SN informed patient that he/she would contact the physician to obtain an order to discharge patient on 06/09/2022 (patient requested this date for discharge); and - No calendar filled out with visit schedule and frequency of visits (SN looked on his/her tablet to see patient’s schedule due to patient confusion about discharge visit). During an interview on 06/07/2022 at 12:05 AM, the administrator reported the following: - The patient should have a calendar filled out with visit schedule and frequency; and - The nurse should have went the following week to do a discharge visit. RECORD/PATIENT #2: Review of the clinical records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; and - Disciplines ordered: PT 2w3 (2 times a week for 3 weeks) and OT (occupational therapy) 1w1, 2w3. During home visit observation on 06/07/2022 at 1:20 PM, showed: - No calendar filled out with visit schedule and frequency of visits; - Spouse reported that patient does not receive a visit schedule in advance; and - Patient receives a call for visits on the week of the visit. RECORD/PATIENT #4: Review of the clinical records showed: - Patient was referred to home health services with primary diagnosis of stroke (damage to the brain from interruption of blood its supply) due to intracerebral hemorrhage (a ruptured blood vessel causes bleeding inside the brain); - Disciplines ordered: SN 1w1, 2w2, PT 1w1, 2w3, OT 2w3, and ST (speech therapy) 1w1, 2w3, 1w1, 2w3; - SN visit notes showed the patient received SN 1 time a week for 4 weeks (visit schedule and frequency differ from POC orders); - PT visit notes showed the patient missed a therapy visit during week 3 (no physician communication note); - PT missed visit for week 4 with a physician communication that noted, “PT to re-schedule attempt for week of 05/15/2022,” but no documentation of attempt being made the week of 05/15/2022; - No documentation of PT discharge visit; and - ST visit notes showed the patient missed a visit during week 2 of speech therapy (no physician communication note). During an interview on 06/08/2022 at 11:05 AM, the therapy manager reported: - Skilled nurse only made 1 visit per week for 4 weeks; - No orders received to change SN visit frequency to 1 time a week for 4 weeks; - ST missed a visit on May 2nd, 2022 and did not fill out a missed visit fax form and submit it to the physician to notify him/her of the missed visit; and - Physical therapy did not communicate with the physician about patient being discharged from therapy and discharge documentation was not completed.

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 agency policy review, clinical record review, and interview, the agency failed to ensure the skilled professionals were providing ongoing interdisciplinary assessment of the patient in three (Records/Patients #2, #4, and #5) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. RECORD/PATIENT #5: Review of the initial POC (plan of care) dated 1/05/2022 to 3/05/2022 showed: - Diagnoses of aftercare following joint replacement surgery, presence of left artificial hip, long term (current) use of opiate analgesic (narcotic pain medication), and long term (current) use of non-steroidal anti-inflammatory (medication used to reduce pain and inflammation); - Medications included, but not limited to: *Gabapentin 800 mg tablet, 1 three times daily (seizure medication also use to treat nerve pain); *Hydrocodone7.5 mg-acetaminophen 325 mg tablet (opioid pain medication), 1 as needed every 4 hours; * Oxycodone 5 mg capsule 1 as needed every 6 hours for pain (narcotic); * Tylenol extra strength arthritis 500 mg 1 as needed every 6 hours for pain not to exceed 4 gr (grain) in 24 hours; * Voltaren 1% topical gel 2 gr as needed topical up to twice a day for joint pain; and *Mobic 15 mg tablet 1 as needed daily for pain. Review of visit notes report dated 01/07/2022 showed under care plan documentation (which is not sent to physician or allowed practitioner for approval) dated 1/5/2022 showed: - Outcome: Therapy- patient will demonstrate effective pain level of control by agency discharge. - Interventions: Therapy *Assess and monitor patient current level of pain (using standardized pain scale); *Assess pain level highs and lows since last therapy visit including the location and description of pain; *Assess/monitor and instruct patient/caregiver in alternative pain management techniques such as relaxation, distraction, massage, hot and cold packs and other modalities as indicated; *Assess/monitor/instruct patient satisfaction with current pain management regimen; and *Consult with physician or SN (skilled nurse) if patient’s pain is not controlled with current regimen. Review of the SOC OASIS dated 01/05/2022, (Outcome and Assessment Information Set- a standardized assessment tool) showed: - Does the patient ever have pain? Yes; - Is the patient experiencing pain? Left blank; - Is the patient able to communicate? Left blank; - Patient exhibits the following nonverbal cues: restlessness; - Pain assessment Site 1: right knee, frequency-intermittent, current level (0-10): 4, worse pain gets (0-10): 8, best pain gets (0-10): 0, increases with activity: yes, description: ache, contributing factors: left blank, relieved by: medication management, relaxation and repositioning, other- Norco as needed every 6 hours, - Pain assessment Site 2: All was left blank; - How often is medication needed? At least daily; - Is the patient satisfied with pain control? Yes; and - Frequency of pain interfering with patient’s activity or movement: Daily, but not constantly. Review of, but not limited to, visit notes report dated 01/07/2022 showed under pain assessment: - Has the patient experienced pain since the last skilled nursing visit? Yes; - Is the patient currently experiencing pain? (Including today’s visit) Yes; - Intensity using scale- 7, followed by a sad face and the number 8- hurts a whole lot; - Pain assessment Site 1: right knee, frequency-left blank, current level (0-10): 7, worse pain gets (0-10): left blank, best pain gets (0-10): left blank, increases with activity: yes, description: sharp and achy, pain on the inside and down the shin, contributing factors: LTHR (left total hip replacement), relieved by: cold compresses, medication management, warm compresses, other: blank; - Pain assessment Site 2: left hip, frequency-left blank, current level (0-10): 3, worse pain gets (0-10): left blank, best pain gets (0-10): left blank, increases with activity: no, description: sore and achy, contributing factors: previous surgery, relieved by: cold compresses, medication management, warm compresses, other: blank; - How often is medication needed? Left blank; and - Is the patient satisfied with pain control? Left blank Review of visit notes report dated 01/07/2022 showed under care plan documentation: - Patient reported his/her right knee was having sharp and achy pain 7-8/10. He/she noted left hip was achy but not too bad 2-3/10; - Educated patient on icwe (possibly a typo meaning ice) to reduce pain in left hip and frequent movement; and - Intervention listed: Therapy assess/monitor/instruct satisfaction with current pain management regimen, consult physician or SN if patient’s pain is not controlled with current regimen- status-not performed. Review of the clinical record failed to show continual involvement of all skilled professional staff involved in the patient’s plan of care from the initial assessment through discharge, including periodic discussions among team regarding the patient’s health status and recommendations for the plan of care when the patient’s pain level exceeded their baseline on admission. During an interview on 06/07/2022 at 12:05 PM the administrator stated that pain is reported to the physician based on clinical judgement. During an interview on 6/08/2022 at 10:04 AM the administrator stated that the agency does get a baseline on admission and report if it is higher than the baseline. Findings included: Review of the agency’s policy titled, “Care Planning Process,” revised 02/08/2022, showed, in part: - The POC (plan of care) should be initiated at the start of care and be an individualized, collaborative document that is contributed to by each discipline, as well as the patient/caregiver; - The following factors should be considered during the care planning process: * Individualized patient needs; * Changes in patient’s condition; * Monitoring effectiveness of medications, as appropriate; * Pain and symptom management, as appropriate; - The POC may include, but will not be limited to: * Individualized goals and interventions; * Specific services to be provided; * 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 agency’s policy titled, “Care Coordination and Ongoing Communication,” revised 08/24/2021, showed: - All associates assigned to a patient’s care will be responsible for coordinating services provided; - The Case Manager will be responsible for the coordination between service providers, including, but not limited to: * Understanding of each team member’s responsibility in providing care; * Initiation of communication with other team members when there are significant changes in the patient’s overall care; - It will be the responsibility of every clinician caring for the patient to facilitate communication about changes in the patient’s status between the physician, other clinicians, and the case manager; - Documentation of all communication will be included in the electronic medical record (EMR); and - Written evidence of care coordination will be found in the patient’s EMR. RECORD/PATIENT #2: Review of the clinical records showed: - Patient was referred to home health services by the primary care provider for physical therapy (PT) to increase strength and mobility in left leg; - PMH (past medical history) of spasms with baclofen pump; - POC had Baclofen 10,000 mcg (micrograms)/20 ml (milliliters) (500mcg/ml) intrathecal solution (vial ml) 1 every one day intrathecal (occurring within or administered into the spinal canal) pump was listed on the medication list (Dose on medication list is the total volume of the medication that is in the pump but does not include daily infusion dose); - Referral record showed the patient is to follow up with (named physician) for ongoing management (for the baclofen pump); - SOC (start of care) visit completed by PT on 05/16/2022, showed, “not assessed” for patient’s height and weight; - Review of the OT visit note on 05/18/2022 showed, “not assessed” on skin integrity; and - Review of the OT visit note on 05/25/2022 showed, patient reported pain rated a 7 out of 10 to LLE (left lower extremity), utilizing icy hot (topical ointment used to help relieve minor aches and pains), and no other documentation of pain assessment (frequency, worst pain, best pain, contributing factors, description of pain, and if patient was satisfied with pain control were all left blank). Observation on 06/07/2022 at 1:20 PM, during the patient's home visit, showed: - The patient had a follow up appointment with the primary care provider regarding medication adjustments; - Physician ordered patient to start taking Gabapentin (used to treat nerve pain); - COTA (occupational therapy assistant) asked the patient if he/she had any medication changes since last visit and reviewed medication bottle for new Gabapentin; - No other medication bottles were reviewed by COTA during medication reconciliation; - Surveyor reviewed medication bottles after the COTA finished medication reconciliation, and found baclofen 10mg tablets with instructions to take up to 3 tablets by mouth daily for "rescue use" only; - Spouse reported that baclofen tablets are for the patient to take in the event the baclofen pump starts alarming and stops delivery the medication; and - Baclofen 10 mg tablets are not listed on the POC (no documentation to clarify “rescue use” instructions and/or orders with the physician. During an interview on 06/07/2022 at 12:40 PM, the administrator reported the following: - Charting should be complete and believes the assessment was completed appropriately but charting does not adequately reflect assessment; - Height and weight should be assessed at SOC; and - Height and weight not obtained and no documentation for reason why. RECORD/PATIENT #4: Review of the clinical records showed: - Patient was referred to home health services with primary diagnosis of stroke (damage to the brain from interruption of blood its supply) due to intracerebral hemorrhage (a ruptured blood vessel causes bleeding inside the brain); - Disciplines ordered: RN (registered nurse), PT, OT (occupational therapy), and ST (speech therapy); - Start of care (SOC) visit completed by RN (registered nurse) on 04/21/2022, showed: * Patient had great difficulty finding his/her words; * Had confusion, forgetfulness, and anxiety at times; * Impaired decision making and memory deficit; * Disruptive behavior reported or observed several times a week; * Pain assessment with “yes” answered to the question asking if patient ever has pain, “no” answered to the question asking if patient was experiencing pain, and “yes” answered to the question asking if patient is able to communicate; * Non-verbal cues of pain was left blank; * Pain assessment section was left blank; - SN visit note on 04/21/2022 has “no” answered to the question asking if patient ever has pain, “no” answered to the question asking if patient was experiencing pain, and “yes” answered to the question asking if patient is able to communicate (No assessment of non-verbal cues of pain); and - PT visit note on 04/22/2022 has “no” answered to the question asking if patient reports pain (no assessment of non-verbal cues of pain and detailed pain assessment section is left blank). During an interview on 06/08/2022 at 11:30 AM, the administrator reported the following: - Acknowledged inappropriate pain assessment for a patient with cognitive impairment that has difficulty communicating; - Non-verbal cues should be documented for a patient with cognitive impairments; and - All charting should be completed. During an interview on 06/08/2022 at 2:10 PM, the director of nursing reported the following: - The RN that completed SOC visit received a corrective action regarding SOC issues; - The agency discovered issues with the SOC visits missing information, including, orders not being entered, visits being missed, and labs not being drawn due to missed visits; and - Written counseling plan occurred on 05/17/2022 (copy provided).

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 agency policy review, clinical record review, and interview, the agency failed to ensure the skilled professionals were providing services ordered by the physician in two (Records/Patients #1 and #4) of five records reviewed. This deficient practice has the potential to affect all patients served by the agency. Findings included: Review of the agency's policy titled, “Care Planning Process,” revised 02/08/2022, showed, in part: - All disciplines involved in the patient’s care will contribute to the POC; - The following factors should be considered during the care planning process: * Individualized patient needs; * Monitoring effectiveness of medications, as appropriate; * Pain and symptom management, as appropriate; - The POC may include, but will not be limited to: * Individualized goals and interventions; * Specific services to be provided; 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. RECORD/PATIENT #1: Review of the clinical records showed: - Patient was referred to home health services following hospitalization for acute diverticulitis (inflammation or infection in one or more small pouches in the digestive tract) with pneumoperitoneum (air or gas in the abdominal cavity) resulting in Hartmann’s procedure (surgical procedure of the colon with closure of the rectum and redirecting the remaining colon to a colostomy), appendectomy (surgical operation to remove the appendix), and release of SBO (small bowel obstruction), with LLQ (left lower quadrant) colostomy (piece of the colon is surgically diverted to an artificial opening in the abdominal wall for excretion of bowel movement); and - Discipline visit frequency included, SN (skilled nurse) 2w2, 1w2 (2 times a week for 2 weeks and 1 time a week for 2 weeks). During home visit observation on 06/06/2022 at 2:15 PM, showed: - Skilled nurse visit to discharge patient from home health services; - Patient reported being unaware that SN would not be making one more visit; - POC (plan of care) showed the patient to be on week 5 with 1 more week of services (patient not due for discharge until following week); - Patient requested one more SN visit before being discharged; - SN informed patient that he/she would contact the physician to obtain an order to discharge patient on 06/09/2022 (patient requested this date for discharge); and - No calendar filled out with visit schedule and frequency of visits (SN looked on his/her tablet to see patient’s schedule due to patient confusion about discharge visit). During an interview on 06/07/2022 at 12:05 AM, the administrator reported the following: - The patient should have a calendar filled out with visit schedule and frequency; and - The nurse should have went the following week to do a discharge visit. RECORD/PATIENT #4: Review of the referral orders showed: - Patient was referred to home health services with primary diagnosis of stroke (damage to the brain from interruption of blood its supply) due to intracerebral hemorrhage (a ruptured blood vessel causes bleeding inside the brain); - Disciplines ordered: RN (registered nurse), PT, OT (occupational therapy), and ST (speech therapy); - Please draw BMP (basic metabolic panel lab is a group of 8 tests that measures several substances in the blood) twice weekly with first draw on May 22, 2022 and fax results to the primary care provider (No documentation of communication with physician to clarify if BMP lab order was to start 04/22/2022 rather than 05/22/2022 due to acute hyperkalemia (high levels of potassium in the blood) with medication ordered to lower potassium level in the blood; and - Start of care within 24-48 hours of hospital discharge, anticipated discharge 04/20/2022. Review of the clinical records showed: - Disciplines ordered: SN 1w1, 2w2, PT 1w1, 2w3, OT 2w3, and ST (speech therapy) 1w1, 2w3, 1w1, 2w3; - SN visit notes showed the patient received SN 1 time a week for 4 weeks (visit schedule and frequency differ from POC orders); - PT visit notes showed the patient missed a therapy visit during week 3 (no physician communication note); - PT missed visit for week 4 with a physician communication that noted, “PT to re-schedule attempt for week of 05/15/2022,” but no documentation of attempt being made the week of 05/15/2022; - No documentation of PT discharge visit; and - ST visit notes showed the patient missed a visit during week 2 of speech therapy (no physician communication note). During an interview on 06/08/2022 at 11:05 AM, the therapy manager reported: - Skilled nurse only made 1 visit per week for 4 weeks; - No orders received to change SN visit frequency to 1 time a week for 4 weeks; - ST missed a visit on May 2nd, 2022 and did not fill out a missed visit fax form and submit it to the physician to notify him/her of the missed visit; and - Physical therapy did not communicate with the physician about patient being discharged from therapy and discharge documentation was not completed. During an interview on 06/08/2022 at 11:30 AM, the director of nursing reported the following: - No documentation of BMP lab order clarification; and - Will check on labs and medication prescribed to lower potassium level. During an interview on 06/08/2022 at 2:10 PM, the director of nursing reported the following: - Documentation from the hospital was obtained and had BMP lab order to begin on Friday April 22nd, 2022 (May 22nd, 2022 was a typo); - PCP (primary care provider) office contacted and patient had BMP lab drawn on 04/22/2022 from PCP (copy obtained); and - Potassium was within normal limits on 04/22/2022 (agency was not aware of normal lab until 06/08/2022).

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 extended level survey, resulting in noncompliance with two Conditions of Participation: Comprehensive assessments of patients and Care Planning, Coordination of Services and Quality of Care, the agency may not train or competency evaluate their home health aides for a period of two (2) years following, the date of this survey. The restriction ends 06/08/2024.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on record review and interview the agency failed to assure all clinical record entries were complete in, but not limited to one (Record/Patient #5) of five full records reviewed. This deficient practice has the potential to affect the care and safety of all patients receiving services from the agency. RECORD/PATIENT #5 Review of the SOC OASIS dated 01/05/2022, (Outcome and Assessment Information Set- a standardized assessment tool) showed, in part: - Is the patient experiencing pain? Left blank; - Is the patient able to communicate? Left blank; - Pain assessment Site 1: right knee, frequency-intermittent, current level (0-10): 4, worse pain gets (0-10): 8, best pain gets (0-10): 0, increases with activity: yes, description: ache, contributing factors: left blank, relieved by: medication management, relaxation and repositioning, other- Norco as needed every 6 hours; and - Pain assessment Site 2: All was left blank. Review of, but not limited to, visit notes report dated 01/07/2022 showed under pain assessment: - Pain assessment Site 1: right knee, frequency-left blank, current level (0-10): 7, worse pain gets (0-10): left blank, best pain gets (0-10): left blank, increases with activity: yes, description: sharp and achy, pain on the inside and down the shin, contributing factors: LTHR (left total hip replacement), relieved by: cold compresses, medication management, warm compresses, other: blank; - Pain assessment Site 2: left hip, frequency-left blank, current level (0-10): 3, worse pain gets (0-10): left blank, best pain gets (0-10): left blank, increases with activity: no, description: sore and achy, contributing factors: previous surgery, relieved by: cold compresses, medication management, warm compresses, other: blank; - How often is medication needed? Left blank; and - Is the patient satisfied with pain control? Left blank During an interview on 06/08/2022 at 10:04 AM the administrator stated that: - He/she (the therapist) has left several blanks; and - This will be discussed with him/her.