Constellation Home Care

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on review of the clinical record, review of agency policy and interview with agency personnel for two of seventeen patients (Patient’s #2 and #5 ) in the survey sample, the agency licensed personnel failed to provide the ordered services. The findings include: Patient #2 had a start of care date of 2/20/25 and diagnoses that included hypertensive heart disease with failure, acute on chronic heart failure and peripheral vascular disease. The physician’s orders dated 2/20/25 included nursing services once weekly for cardiovascular assessments and teaching regarding congestive heart failure disease process and physical therapy services once weekly for muscle strengthening, gait training and assessing compliance with taking weights daily and reporting weight gain of three pounds daily and five pounds weekly. Interview and review of the physical therapy assistant/PTA clinical notes dated 3/01/25 and 3/07/25 with the Administrator and Clinical Manager/CM on 3/25/25 at 1:15 PM identified missed visit notes which identified the patient was unavailable for the visit, the PTA was unable to contact the patient by phone and there was no answer at the door, but failed to identify physician notification of the missed visits and failed to ensure physical therapy services were provided weekly as ordered. Review of agency policy for Patients Not Home/Not Found directed the physicians will be notified of patients not home/not found to ensure optimal safety of the patient, and the physician is notified of the change to the plan of care. Patient #5 had a start of care date of 03/11/2025 with diagnoses of hypertension, heart failure, chronic kidney disease and anemia. The physician’s orders for the certification period of 03/11/2025 to 05/09/2025 included nursing services once weekly for three weeks and physical therapy one to two times per week. Review of Patient #5’s plan of care interventions dated 03/11/2025, identified to assess the Patient’s cardiovascular status for signs and symptoms of card”

“Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA’s policies and procedures. This Standard is not met as evidenced by: Based on review of the clinical record, review of agency policies and interview with agency personnel, for two of fifteen patient’s (Patient #2 and #17) in the survey sample, the agency licensed personnel failed to follow agency policies. The findings include: Patient #--- Patient #2 had a start of care date of 2/20/25 and diagnoses that included hypertensive heart disease with failure, acute on chronic heart failure and peripheral vascular disease. The physician’s orders dated 2/20/25 included nursing services once weekly for assessments and physical therapy services. Interview and review of the physical therapy assistant/PTA clinical notes dated 3/01/25 and 3/07/25 with the Administrator and Clinical Manager/CM on 3/25/25 at 1:15 PM identified missed visit notes which identified the patient was unavailable for the visit, the PTA was unable to contact the patient by phone and there was no answer at the door, but failed to identify Physician and/or Therapy Case Manager notification of the missed visits. Review of agency policy for Patients Not Home/Not Found directed the physicians will be notified of patients not home/not found to ensure optimal safety of the patient, and the physician is notified of the change to the plan of care. If the patient cannot be found, call the emergency contact, notify the physician, notify the Registered Nurse/RN or Therapy Case Manager.”

“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 clinical record review, review of agency policy and interview with agency personnel, for three of seventeen patients (Patient’s #2, #3 and #17 )in the survey sample, the agency nurses failed to ensure the plan of care addressed the patient’s individual needs and failed to follow physician’s orders. The findings include. Patient #2 had a start of care date of 2/20/25 and diagnoses that included hypertensive heart disease with failure, acute on chronic heart failure and peripheral vascular disease. The physician’s orders dated 2/20/25 included nursing services once weekly for cardiovascular assessments, assessing anticoagulant therapy laboratory values and teaching regarding congestive heart failure disease process and physical therapy services once weekly for muscle strengthening, gait training and assessing compliance with taking weights daily and reporting weight gain of three pounds daily and five pounds weekly. Physician’s orders included Warfarin (blood clot prevention) 3 milligrams/mg, take 1.5 tablets orally once daily for a total of 4.5 mg as instructed by the pharmacist at the Coumadin Clinic. i. Interview and review of nursing notes dated 2/20/25, 2/25/25, 2/27/25, 3/06/25 and 3/15/25 with the Administrator and CM on 3/26/25 at 11 AM identified documentation of the nurses performing an INR fingerstick (International Normalized Ratio), a blood test used to measure how long it takes for blood to clot, and reporting the results to the Coumadin Clinic although, review of the physician’s orders failed to identify the need for the nurses to perform the INR fingerstick and failed to ensure a plan of care to meet the patient’s needs. ii. Interview and review of physician’s orders and initial nursing assessment with the Administrator and CM on 3/26/25 at 10 AM identified teaching regarding congestive heart failure disease process but failed to clarify with the physician the need for weight monitoring and parameters for reporting abnormal results. Review of the agency policy for Plan of Care directed all clinical services are provided in accordance with the plan of care established by the physician’s written orders. The plan of care is based on the assessment of the patient’s immediate and long-term needs. a. Patient #3 had a start of care date of 02/19/2025 with diagnoses that included type II diabetes, hypertension, congestive heart failure, atrial fibrillation and dementia. The physician’s orders dated 02/19/2025 included nursing services once weekly for three weeks for assessments, disease process teaching for diabetes and heart failure management, physical therapy services once weekly for four weeks and occupational therapy once weekly for three weeks. Review of Patient #3’s plan of care interventions dated 02/19/2025, identified to assess cardiovascular status for signs and symptoms of cardiac complications and indicated the Patient does not check his/her blood glucose levels regularly. i. Interview and review of the initial nursing assessment with the Supervisor of Clinical Services (SCS) #1 on 03/26/2025 at 11:00 AM failed to clarify with the physician the need for nursing to monitor blood glucose levels and daily weights with parameters for reporting abnormal results. b. Patient #17 had a start of care date of 09/21/2024 with diagnoses that included laceration to the lower leg, Alzheimer’s disease, heart disease and type II diabetes. The physician’s orders for the certification period of 09/21/2024 to 11/19/2024 included nursing services for assessments one to two times per week, physical therapy one to two times per week for three weeks and occupational therapy once weekly for four weeks. Review of Patient #17’s clinical record identified the Patient was hospitalized and had a home health resumption of care nursing visit on 10/19/2024. The physician’s orders were for nursing services two to three times per week for two weeks to assess for changes or alterations in the Patient’s cardiovascular status. Additionally, the nurses were to teach nephrostomy (a tube that is inserted into the kidney through the skin that drains urine into a bag) care and flush the tube three times per week. ii. Interview and review of Patient #17’s clinical record with SCS #1 on 03/26/2025 at 11:15 AM, identified the nurses were irrigating the nephrostomy tube three times per week, but failed to identify the physician’s order or plan of care for the irrigation included the amount of, and the type of solution used. a. P”

“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 review of the clinical records and interviews with agency personnel, for one of twelve current patients (Patient’s #5) the agency licensed personnel failed to ensure interdisciplinary communication of the patient’s needs. The findings include: Patient #5 had a start of care date of 03/11/2025 with diagnoses of hypertensive heart disease with failure, chronic kidney disease and anemia. The physician’s orders for the certification period of 03/11/2025 to 05/09/2025 included nursing services once weekly for three weeks for cardiovascular assessments, teaching regarding congestive heart failure, compliance with taking weights daily and reporting a weight gain of three pounds daily and five pounds weekly. Additionally, the Patient received physical therapy one to two times per week. Observation of Licensed Practical Nurse (LPN) #1 on 03/24/2025 at 1:45 PM during a home health nursing visit for Patient #5, the Patient’s caregiver identified the Patient was unable to stand on a scale due to poor balance and weakness, resulting in daily weights were not being obtained. Interview and review of Patient #5’s clinical with the Administrator and Clinical Manager on 03/26/2025 at 11:30 AM, identify LPN #1 failed to notified the Patient’s physician of the Patient’s inability to stand on a scale to monitor daily weights.”

“Services by skilled professionals CFR(s): 484.75(a) Standard: Provision of services by skilled professionals. Skilled professional services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications specified under §484.115 and who practice according to the HHA’s policies and procedures. This Standard is not met as evidenced by: Based on clinical record reviews, interviews with agency personnel, review of agency documentation and agency policies, for one of three patients (Patient #1) who required indwelling catheter management, the home health nurse failed to follow agency policies. The findings include: a. Patient #1 had a start of care date of 08/17/2023 with diagnoses of benign prostatic hyperplasia, urine retention, flaccid neuropathic bladder, and long-term use of anticoagulants. The physician orders for the certification period of 04/13/2024 to 06/11/2024 included nursing services once per month for two months to assess for urinary tract infections, to ensure the Patient’s indwelling urinary catheter (a tube that is inserted through the urethra and into the bladder to relieve urinary retention and to provide continuous drainage of urine) was functioning, irrigate the urinary catheter with 100 ml of normal saline every two weeks and change the indwelling urinary catheter once per month. Review of Patient #1’s nursing note dated 06/01/2024, identified Registered Nurse (RN) #1 conducted an unscheduled nursing visit as the Patient’s private duty caregiver notified the home health agency that Patient #1’s indwelling urinary catheter was leaking. RN #1 identified the indwelling urinary catheter bag contained a small amount of dark amber colored urine. RN #1 further identified the Patient had urine leaking around the catheter, but the Patient declined a nursing assessment and a catheter change. Patient #1 agreed RN #1 could return on 06/02/2024. Review of Patient #1’s nursing note dated 06/02/2024, identified the Patient’s private duty caregiver reported the catheter continued to leak, the Patient was saturated in urine upon waking and his/her urinary output was less than 100 ml of dark amber colored urine. RN #1 proceeded to remove the previous catheter, inserted a new catheter and made three attempts to inflate the catheter’s balloon with 5 ml of saline, but the Patient complained of pain with each attempt. RN #1 removed the catheter and observed a small amount of blood on the Patient’s meatus. RN #1 called the home health agency’s supervisor, notified the Patient’s responsible person and called for emergency medical services (EMS) to transport the Patient to the hospital. Review of Patient #1’s hospital discharge summary dated 06/04/2024, identified the Patient was evaluated in the emergency department on 06/02/2024 for rigors (chills) and hematuria (blood in urine). Patient #1 was diagnosed with a urinary tract infection and systemic inflammatory response syndrome (SIRs) due to the recent indwelling urinary catheter change on 06/02/2024. Patient #1 was discharged home on 06/04/2024 with a new indwelling urinary catheter and was prescribed an oral antibiotic. Review of the agency’s investigation dated 06/06/2024, identified RN #1 performed a catheter inserted on Patient #1 on 06/02/2024 resulting in hematuria and the need for the patient to be evaluated at the hospital. The investigation identified while at the emergency department, the Patient was diagnosed with a urinary tract infection and SIRs from the catheterization. As a result of the investigation, RN #1 was not allowed to perform indwelling urinary catheter insertions until a direct observation by a supervisor was conducted to ensure RN #1’s catheterization procedure. Review of Patient #1 hospital summary dated 06/08/2024, identified the Patient returned to the emergency department for hematuria and bladder pain. The Patient remained in hospital and returned home with the agency resuming the Patient’s care on 06/12/2024. i. Interview and review of Patient #1’s clinical record and the agency’s investigation on 06/06/2024 at 11:45 AM with the Supervisor of Clinical Services (SCS) #1, failed to identify on 06/01/2024 the nurse notified Patient #1’s physician of the Patient’s dark amber colored urine, the Patient declining a nursing assessment and catheter change in accordance with the agency’s policy. Additionally, the agency failed to identify the nurse followed the male foley catheterization policy. Review of the agency’s Change in Condition policy, identified the supervisor of clinical services should be informed of all changes in a patient’s condition. A change is defined as any change that would impact the course of the patient’s recovery and the development of symptoms that would require a physician to make changes to the patient’s plan of care. Some examples of a change in condition would be the development of signs and symptoms of infection that required treatment. The clinician would contact the patient’s physician, obtain direction/orders from the physician regarding observed changes and discuss any changes in the plan of care with patient/ caregiver to reflect their involvement. Review of the agency’s male foley catheterization policy identified the clinicians would carefully insert lubricated foley catheter into urethral meatus until urine begins to flow. If resistance to foley catheter insertion is met, discontinue catheterization procedure and notify the physician. The clinical is to report any signs or symptoms of infection to a physician.”

“Communication with physicians CFR(s): 484.75(b)(7) Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care; This Element is not met as evidenced by: Based on clinical record reviews, review of agency policies, and interviews with agency personnel for one of three (Patient’s #1) who required indwelling urinary catheter management, the agency failed to notify the patient’s health care provider of a change in a patient’s condition. The findings include: a. Patient #1 had a start of care date of 08/17/2023 with diagnoses of benign prostatic hyperplasia, urine retention, flaccid neuropathic bladder, and long-term use of anticoagulants. The physician orders for the certification period of 04/13/2024 to 06/11/2024 included nursing services once per month for two months to assess for urinary tract infections, to ensure the Patient’s indwelling urinary catheter (a tube that is inserted through the urethra and into the bladder to relieve urinary retention and to provide continuous drainage of urine) was functioning, irrigate the urinary catheter with 100 ml of normal saline every two weeks and change the indwelling urinary catheter once per month. Review of Patient #1’s nursing note dated 06/01/2024, identified Registered Nurse (RN) #1 conducted an unscheduled nursing visit as the Patient’s private duty caregiver notified the home health agency that Patient #1’s indwelling urinary catheter was leaking. RN #1 identified the indwelling urinary catheter bag contained a small amount of dark amber colored urine. RN #1 further identified the Patient had urine leaking around the catheter, but the Patient declined a nursing assessment and a catheter change. Patient #1 agreed RN #1 could return on 06/02/2024. Review of Patient #1’s nursing note dated 06/02/2024, identified the Patient’s private duty caregiver reported the catheter continued to leak, the Patient was saturated in urine upon waking and his/her urinary output was less than 100 ml of dark amber colored urine. RN #1 proceeded to remove the previous catheter, inserted a new catheter and made three attempts to inflate the catheter’s balloon with 5 ml of saline, but the Patient complained of pain with each attempt. RN #1 removed the catheter and observed a small amount of blood on the Patient’s meatus. RN #1 called the home health agency’s supervisor, notified the Patient’s responsible person and called for emergency medical services (EMS) to transport the Patient to the hospital. Review of Patient #1’s hospital discharge summary dated 06/04/2024, identified the Patient was evaluated in the emergency department on 06/02/2024 for rigors (chills) and hematuria (blood in urine). Patient #1 was diagnosed with a urinary tract infection and systemic inflammatory response syndrome (SIRs) due to the recent indwelling urinary catheter change on 06/02/2024. Patient #1 was discharged home on 06/04/2024 with a new indwelling urinary catheter and was prescribed an oral antibiotic. Review of the agency’s investigation dated 06/06/2024, identified RN #1 performed a catheter inserted on Patient #1 on 06/02/2024 resulting in hematuria and the need for the patient to be evaluated at the hospital. The investigation identified while at the emergency department, the Patient was diagnosed with a urinary tract infection and SIRs from the catheterization. As a result of the investigation, RN #1 was not allowed to perform indwelling urinary catheter insertions until a direct observation by a supervisor was conducted to ensure RN #1’s catheterization procedure. Review of Patient #1 hospital summary dated 06/08/2024, identified the Patient returned to the emergency department for hematuria and bladder pain. The Patient remained in hospital and returned home with the agency resuming the Patient’s care on 06/12/2024. i. Interview and review of Patient #1’s clinical record and the agency’s investigation on 06/06/2024 at 11:45 AM with the Supervisor of Clinical Services (SCS) #1, failed to identify on 06/01/2024 the nurse notified Patient #1’s physician of the Patient’s dark amber colored urine, the Patient declining a nursing assessment and catheter change in accordance with the agency’s policy. Additionally, the agency failed to identify the nurse followed the male foley catheterization policy. Review of the agency’s Change in Condition policy, identified the supervisor of clinical services should be informed of all changes in a patient’s condition. A change is defined as any change that would impact the course of the patient’s recovery and the development of symptoms that would require a physician to make changes to the patient’s plan of care. Some examples of a change in condition would be the development of signs and symptoms of infection that required treatment. The clinician would contact the patient’s physician, obtain direction/orders from the physician regarding observed changes and discuss any changes in the plan of care with patient/ caregiver to reflect their involvement. Review of the agency’s male foley catheterization policy identified the clinicians would carefully insert lubricated foley catheter into urethral meatus until urine begins to flow. If resistance to foley catheter insertion is met, discontinue catheterization procedure and notify the physician. The clinical is to report any signs or symptoms of infection to a physician.”