Elara Caring

“Condition of Participation: Patient rights. CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient’s rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This Condition is not met as evidenced by: Based on a review of clinical records, review of agency documentation, and interviews with agency personnel, the home health agency failed to ensure a patient was protected from injury when a nurse “fell on the patient” resulting in injury, and neglected to maintain constant supervision of a patient in accordance with the plan of care. Please refer to: G0430 Rights of the Patient”

“Update of the comprehensive assessment CFR(s): 484.55(d) Standard: Update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the administration of the OASIS) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than- This Standard is not met as evidenced by: Based on a review of clinical records, agency documentation, and interviews with agency personnel, for one of two patients (Patient #1) reviewed for completion of an updated assessment related to a change in condition, the agency failed to ensure that a comprehensive Registered Nurse (RN) assessment was conducted timely when the patient had a change in condition. The finding includes: Patient #1 had diagnoses that included congenital malformations of the trachea, convulsions, compression fractures to the spine, scoliosis, osteoporosis, hearing loss, visual loss in both eyes, and intellectual disabilities. Additionally, Patient #1 resided at home with responsible caregiver, and required assistance from the home health agency nurses when transferring to bed. The physician orders for the certification period of 08/09/2025 through 10/07/2025, directed the Patient receive private duty nursing services for ten (10) hour shifts daily from 8:00 AM to 07:00 PM. including the weekends, for nursing assessments, tracheostomy management (a surgically placed opening through the neck to create an airway), gastrointestinal tube management (a surgically placed device used to give direct access to the Patient’s stomach for supplemental feeding, hydration, or medications) and personal care. Additionally the Patient required twenty-four (24) hours supervision to ensure safety, airway, aspiration, respiratory, seizure and fall precautions were maintained. Review of Patient #1’s clinical record of 09/20/2025 identified LPN #1 worked from 08:00 AM to 06:00 PM and did not document in the record during his/her shift. Review of LPN #2’s nursing notes dated 09/21/2025, identified Patient #1’s left eye was red, and the Patient was having difficulty self propelling in his/her wheelchair and had a bruise to the left knee. The responsible caregiver reported to LPN #2 they observed that the Patient’s left eye was red and swollen the previous evening, and the Patient was evaluated by an ophthalmologist on 09/20/2025 and prescribed an antibiotic for an infection. Registered Nurse (RN) #2 (Field Supervisor) was notified on 09/20/2025 at 4:40 PM and was given an update of all the above. Review of LPN #2’s nursing notes dated 09/22/2025, identified Patient #1 had bruising to the bridge of the nose, lips, and under the left eye. The clinical record identified that LPN #2 notified RN #3 (Field Supervisor) of the additional bruises observed during the visit. Review of the agency documentation dated 09/23/2025 identified patient #1’s responsible caregiver reported that on 09/20/2025 the family hear a loud noise from the area in the home where the Patient and LPN #1 were, A family member responded and noticed a change to LPN #1, who appeared “upset” but told the family member s/he was good. The caregiver indicated later in the evening s/he noticed the Patient was having trouble seeing and had soreness in his/her back and was taken to the physician (Ophthalmologist) for evaluation. Review of LPN #2 nursing notes dated 09/24/2025 indicated the responsible caregiver reported that Patient #1 may have sustained a head injury or had a fall and due tot he facial injuries and was evaluated by the primary physician, that included a Computed Tomography (CT) scan of the head and back, the previous evening. Additionally, the responsible caregiver reported that the ophthalmologist indicated that the redness to the left eye could be from an injury. The CT scan dated 09/26/2025, identified no acute fractures or traumatic fractures to the spine or facial bones. Review of the clinical record during the period of 09/21/2025 through 10/05/2025 failed to identify that a RN assessed the Patient after several bruises were noted by LPN #2 and reported to RN #2 (Field Supervisor) on 09/21/2025 and reported to RN #3 (Field Supervisor) on 09/22/2025. Review of the record dated 10/06/2025 identified a recertification assessment was completed, however failed to document a change in condition from injuries sustained in the Patient’s home on 09/20/2025. Review of Patient #1’s clinical record, agency investigation and interview with the Administrator on 03/02/2026 at 11:00 AM, identified it is the expectation that a RN assesses a patient if a change in condition is suspected and for the LPNs to report their concerns to the agency RN. The Administrator stated that the RN that performed the Patient’s assessment was involved in the investigation, knew of the injuries and concerns, but did not conduct a change of condition assessment related to those injuries and concerns when s/he conducted the recertification visit on 10/06/25. Review of the Comprehensive Assessment Updates, policy identified an updated comprehensive assessment will be completed by an RN when there is a significant change in the patient’s condition, due to a decline in the patient’s health status that was not anticipated, and results in a change in the plan of care. Update of the comprehensive assessment should be considered but not exclusive to an unexpected fall with injuries resulting in a new treatment ordered or an overall decline in condition.”

“Be free from abuse CFR(s): 484.50(c)(2) Be free from verbal, mental, sexual, and physical abuse, including injuries of unknown source, neglect and misappropriation of property; This Element is not met as evidenced by: Based on a review of clinical records, review of agency documentation, and interviews with agency personnel, for one of two patients (Patient #1 ) reviewed for neglect, the agency neglected to ensure the safety of a patient “when a nurse fell on a patient “. In addition, the nurse neglected to report the incident as expected. The finding includes. a. Patient # 1 had a diagnoses that included congenital malformations of the trachea, convulsions, compression fractures to the spine, scoliosis, osteoporosis, hearing loss, visual loss in both eyes, and intellectual disabilities. Additionally, Patient #1 resides at home with responsible caregivers, self-propelled in a wheelchair, would slide his/her body on the floor to the bathroom and required assistance from the home health agency nurses when transferring into bed. The physician’s orders for the certification periods of 08/09/2025 through 10/07/2025, directed Patient #1 receive private duty nursing services for ten (10) hour shifts daily from 08:00AM to 06:00PM, including the weekends, for nursing assessments, tracheostomy management (a surgically placed opening through the neck to create an airway), gastrointestinal tube management (a surgically placed device used to give direct access to the Patient’s stomach for supplemental feeding, hydration or medications) and personal care. Additionally, the Patient required twenty- four (24) hour supervision to ensure safety, airway, aspiration, respiratory, seizure and fall precautions were maintained. Review of Patient #1’s clinical record of 09/20/2025 identified Licensed Practical Nurse (LPN)#1 worked from 08:00AM to 06:00PM and did not document in the record during his/her shift. Review of LPN #2’s nursing note dated 09/21/2025, identified Patient #1’s left eye was red, and the Patient was having difficulty self-propelling in his/her wheelchair and had a bruise to the left knee. The responsible caregiver reported to LPN #2 he/she observed that the patients left eye was red and swollen the previous evening, and the Patient was evaluated by an Ophthalmologist on 09/20/2025 and prescribed an antibiotic for an infection. Review of LPN #2’s nursing note dated 09/22/2025, identified Patient #1 had bruising to the bridge of the nose, lips and under the left eye. Review of the agency documentation dated 09/23/2025 identified the Patients primary care giver contacted the agency to advise that LPN #1 did not show up for his/her assigned shift and also to report that something had happened at the home while LPN #1 was caring for the Patient on 09/20/2025, but the caregiver was not able to get any answers from LPN #1 regarding the nature of the incident. Patient #1’s responsible caregiver further reported that on 09/20/2025 the family heard a loud noise from the area in the home where the Patient and LPN #1 were. A family member responded and noticed a change to LPN #1, who appeared “upset”, but told the family member s/he was good. Caregiver indicated later in the evening s/he noticed the patient was having trouble seeing and had soreness in his/her back and was taken to the physician (Ophthalmology) for evaluation. Per the caregiver, attempts to contact LPN #1 were made on 09/23/2025 with no contact. The caregiver further indicated receiving a call back from LPN #1 and arranging a private meeting on 09/24/2025. Caregiver stated LPN #1 told him/her that s/he had taken an over-the-counter nighttime cold medication as a sleep aide the previous night, 09/19/2025 and then took another dose around 03:00AM on 09/20/2025 prior to reporting for the dayshift to care for Patient #1. LPN #1 indicated laying on a floor mat resting with the Patient, then stood up, lost balance, tripped and fell onto the Patient. LPN #1 did not report the fall to the Patient’s responsible caregiver, the physician, or to the home health agency’s supervisor and continued working the shift. Review of LPN #2’s nursing note dated 09/24/2025 indicated the responsible caregiver reported that Patient #1 may have sustained a head injury or had a fall, due to the facial injuries and was evaluated by the primary care physician, that included a Computed Tomography (CT) scan of the head and back the previous evening., Additionally, the responsible caregiver reported that the Ophthalmologist indicated that the redness to the left eye could be from the injury. The CT scan dated 09/26/2025, identified no acute fractures or traumatic fractures to the spine or facial bones. Interview with the Administrator on 03/22/2026 at 11:00AM identified that during a Teams (electronic communication platform) meeting on 09/26/2025, LPN #1 stated s/he tripped on the mat where the Patient was lying in his/her room, and grabbed onto the crib to catch herself, twisted and as she fell down, may have bumped into the Patient’s back with his/her thigh. LPN #1 did not document the incident and didn’t notify the agency to have the patient assessed by an RN. The Administrator stated LPN #1 did not feel the incident was significant and did not report it to anyone. The Administrator stated LPN #1 was suspended pending the outcome of the investigation and would not be allowed to care for Patient #1. Subsequent to the home health agency’s investigation, LPN#1 was terminated on 10/02/2025 for not following the code of professional conduct, falling on the patient and not reporting to the appropriate authorities an incident resulting in an injury. Review of the Patient/Family Rights & Responsibilities policy, identified Patient’s have the right to be free from mistreatment, neglect, verbal, mental, sexual and physical abuse, including injuries of unknown sources and that staff must immediately report suspected abuse, neglect, or injury to the home health agency and other appropriate authorities in accordance with the state law.”

“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 a review of clinical records, review of agency documentation, and interviews with agency personnel for one of two patients (Patient #2) reviewed for compliance with physician orders, the agency failed to ensure nursing staff maintained constant supervision of the patient in accordance with the physician orders. The finding includes: Patient #2 had a start of care date of 12/03/2024 with diagnoses of premature birth, anemia, intestinal failure, short bowel syndrome and convulsions. Additionally, Patient # 1 resided at home with family. The physician’s orders for the certification period of 06/01/2025 through 07/30/2025, directed that Patient #2 receive private duty nursing services for nursing assessments, gastrointestinal tube management (a surgically placed device used to provide direct access to the Patient’s stomach for supplemental feeding, hydration, and medication administration), tube feedings, medication administration, and personal care. Additionally, Patient #2 required twenty-four hour (24) care and supervision, for airway and aspiration precautions, emergency precautions, fall precautions to ensure safety, and supervision to maintain patient’s airway, oxygen level and respiratory status, and aspiration/swallowing precautions. Review of RN #1’s nursing note dated 06/13/2025, identified while RN #1 was providing care to Patient #2, the Patient’s responsible caregiver contacted a minor family member in the home by telephone, and asked to speak to them privately. RN #1 reported leaving the room and going to the bathroom to provide privacy to the family member. RN #1 reported hearing the minor family member providing care to Patient #2. RN #1 indicated while in the bathroom, they sent a message to the Patient’s responsible caregiver informing him/her that the family member was providing care to the Patient. RN #1 documented leaving the bathroom and returning to provide care to Patient #2. RN #1 indicated seeing two unfamiliar individuals enter the Patient’s home, with the Patient’s responsible caregiver. RN #1 also indicated when the responsible caregiver entered the home, s/he state that RN #1 was “crazy for being in the bathroom” while the minor family member was on the phone. RN #1 identified as this time s/he reported feeling unsafe and left the residence. RN #1 contacted the Pediatric Supervisor of Clinical Services (SCS #2), who advised RN #1 to contact the home health agency to report the incident. Review of the home health agency’s investigation dated 06/16/2025, identified that Patient #2’s responsible caregiver contacted the agency and requested RN #1 not return to the Patient’s home following the incident on 06/13/2025.The investigation identified that RN #1 reported going into the bathroom to provide privacy while the Patient’s responsible caregiver spoke by telephone with a minor family member who was with the patient in the home. While in the bathroom, RN #1 reported hearing the minor family member providing care to Patient #2, who required continuous supervision in accordance with the care plan. RN #1 reported sending a message to the responsible caregiver while in the bathroom and waiting approximately 20 minutes for a response. The investigation identified that on 06/20/2025, RN # 1 received a final written warning related to leaving Patient #2 in the presence of the minor family member for approximately twenty (20) minutes. And subsequently, RN #1’s employment with the agency was terminated on 11/13/2025. Interview with the Administrator on 03/02/2026 at 12:00 PM, identified that on 06/13/2025 RN #1 left Patient #2 without direct nursing supervision and care for approximately twenty (20) minutes while the Patient remained in the presence of a minor family member. The Administrator stated the agency would expect the nurses to provide care and supervision of the patient at all times, which included not leaving the patient at any time, according to the physician order, and did not adhere to the agency policy. Review of the agency’s Plan of Care policy, identified home health services are furnished under the supervision and direction of the client’s physician or allowed practitioner. The plan of care is based on a comprehensive assessment and information provided by the client/family and the health team members. The care plan will be consistently reviewed to ensure that clients needs are met and will be updated as needed. Professional staff shall promptly alert the physician or allowed practitioner to any changes that suggest a need to alter the plan of care.”

“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, reviews of agency policies and interviews with agency personnel, for three of three patients (Patient’s #1, 2 & 3) requiring medication administration, the agency nurses failed to follow agency policies. The findings include: a. Patient #1 had a start of care date of 1/19/22 and diagnoses that included paranoid schizophrenia. The physician’s orders for the certification period of 3/04/25 to 5/02/25 included nursing services twice daily for medication administration and assessments. Physician’s orders included Lorazepam (an antianxiety medication) 1 milligram/mg twice daily. Interview and review of the March 2025 and April 2025 Medication Administration Records/MARs with the Administrator on 5/12/25 at 11:00 AM failed to identify a medication count was conducted for the remaining tablets of Lorazepam, (a Schedule IV Controlled Substance), after each administration by the agency nurse, at the end of each visit, according to agency policies. Review of agency policy for Controlled Substances directed when controlled substances are administered by agency staff, the substances will be counted at the end of each visit and upon discontinuation of services or of the controlled substance medication. Further review of agency documentation dated 3/07/25 identified a medication error report indicating that RN #1 administered morning medications, that had already been administered by LPN #1 twenty minutes earlier to Patient #1. The medications were Benztropine 2 mg, Divalproex 500 mg, Perphenazine 16 mg, Perphenazine 8 mg, Vitamin E mixed 400 units and Lorazepam 1 mg. Interview with RN #1 on 5/12/25 at 11:30 AM indicated after speaking with LPN #1 earlier that morning and understanding that s/he was running late, RN #1 entered the RCH to assist in administering medications to other patients, checked the RCH MAR and noticed Patient #1’s medications were not signed off as administered (no initials for 3/07/25 were on the RCH MAR). RN #1 identified he/s proceeded to open the medication lock box, pour the medications listed above and administer them to the patient. Subsequent to the medication administration, RN #1 observed prior documentation from LPN #1 on the home health agency MAR, located in the lock box, identifying that the medications were administered earlier by LPN #1. Interview and review of the agency documentation with the Administrator on 5/12/25 at 11 AM indicated that RN #1 failed to utilize the medication profile/MAR while administering medications to the patient in accordance with agency policies. Review of the agency policy for Medication Administration and Documentation in MAR directed with each visit/medication administration/pre-pour reconcile/verify accuracy of the MAR, compare MAR to the plan of care order; Verify that the medication is the correct one based on the order and the product label, that the medication being administered is at the correct time, in the correct dose, and by the correct route; Initial medications on the listed MAR beside the date/time of administration/pre-pour. Interview and review of Patient #1’s clinical record from 3/04/35 to 5/02/25 with the Administrator on 5/12/25 at 11:10 AM identified incomplete documentation in a coordination note of missed evening visits on 3/13/25, 3/18/25 and 4/27/25, and failed to follow agency policies for documenting completion of the missed visit note. Review of agency policy for Missed Visit Best Practices directed the physician must be notified of missed visits and documented in a missed visit note, complete every section of the missed visit note including reason for the missed visit, name and method of physician/provider notification. b. Patient #2 had a start of care date of 6/03/22 and diagnoses that included schizoaffective disorder and post-traumatic stress disorder. The physician’s orders for the certification period of 3/19/25 to 5/17/25 included nursing services twice daily for medication administration and assessments. Physician’s orders included Aristada (an antipsychotic medication) 1,064 mg/3.9 milliliter suspension extended-release intramuscular injection monthly. Interview and review of the March 2025 and April 2025 MAR’s with the Administrator on 5/12/25 at 12:30 PM identified the monthly injection was administered on 3/04/25 and 4/04/25 but failed to include the site of Aristada suspension administered. c. Patient #3 had a start of care date of 5/07/24 and diagnoses that included schizophrenia, seizures, depression and traumatic brain injury. The physician’s orders for the certification period of 3/03/25 to 5/01/25 included nursing services twice daily for medication administration and assessments. Physician’s orders included Fluphenazine Decanoate (an antipsychotic medication) 25 mg/ml injection solution every other week. Interview and review of the April 2025 MAR with the Administrator on 5/12/25 at 12:40 PM identified the every other week injection was administered on 4/01/25, 4/15/25 and 4/29/25 but failed to include the site of Fluphenazine administered. Review of agency policy for Medication Administration directed that route of administration should include a specific anatomical site, if clinically indicated.”

“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 clinical record review, review of agency policies and interviews with agency personnel for three of three patients (Patient’s #1, 2 & 3) in the survey sample, the agency failed to ensure an accurate and legible record. The findings include: a. Patient #1 had a start of care date of 1/19/22 and diagnoses that included paranoid schizophrenia. The physician’s orders for the certification period of 3/04/25 to 5/02/25 included nursing services twice daily for medication administration and assessments. b. Patient #2 had a start of care date of 6/03/22 and diagnoses that included schizoaffective disorder and post-traumatic stress disorder. The physician’s orders for the certification period of 3/19/25 to 5/17/25 included nursing services twice daily for medication administration and assessments. c. Patient #3 had a start of care date of 5/07/24 and diagnoses that included schizophrenia, seizures, depression and traumatic brain injury. The physician’s orders for the certification period of 3/03/25 to 5/01/25 included nursing services twice daily for medication administration and assessments. Interview and review of Patient’s #1, #2 and #3 March 2025 and April 2025 MARs with the Administrator on 5/12/25 at 1:30 PM identified illegible signatures by the agency nurses at the bottom of the MAR’s and twice daily illegible initialed documentation of medications administered using only the initial of the nurse’s first name and failed to ensure legible documentation. Review of the agency policy for Clinical Record Content directed all documentation must be legible and written in black or blue ink or in electronic format.”

“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, and interviews with agency personnel, for two of three patients (Patient’s #1 & 3) in the survey sample, the agency nurses failed to notify the physician of an alteration in the care plan. The findings include: a. Patient #1 had a start of care date of 1/19/22 and diagnoses that included paranoid schizophrenia. The physician’s orders for the certification period of 3/04/25 to 5/02/25 included nursing services twice daily for medication administration and assessments. Interview and review of the nursing note dated 4/21/25 at 7:25 AM with the Administrator on 5/12/25 at 11:10 AM identified the patient refused medication administration but failed to identify communication with the physician of the medications refused. b. Patient #3 had a start of care date of 5/07/24 and diagnoses that included schizophrenia, seizures, depression and traumatic brain injury. The physician’s orders for the certification period of 3/03/25 to 5/01/25 included nursing services twice daily for medication administration and assessments. Physician’s orders included Fluphenazine Decanoate (an antipsychotic medication) 25 mg/ml injection solution every other week. Interview and review of the March 2025 MAR with the Administrator on 5/12/25 at 12:45 PM identified the every other week injection was administered on 4/07/25, was due on 4/21/25 but had not been administered as evidenced by unclear documentation on the MAR of no syringes available and failed to notify the physician of the missed dose.”

“Must have a written agreement CFR(s): 484.105(e)(2)(i-iv) An HHA must have a written agreement with another agency, with an organization, or with an individual when that entity or individual furnishes services under arrangement to the HHA’s patients. The HHA must maintain overall responsibility for the services provided under arrangement, as well as the manner in which they are furnished. The agency, organization, or individual providing services under arrangement may not have been: (i) Denied Medicare or Medicaid enrollment; (ii) Been excluded or terminated from any federal health care program or Medicaid; (iii) Had its Medicare or Medicaid billing privileges revoked; or (iv) Been debarred from participating in any government program. This Element is not met as evidenced by: Based on clinical record review and interview with agency personnel, for three of three patients (Patient’s #1, 2 & 3) who resided in a Residential Care Home/RCH, the agency Registered Nurse/RN failed to complete a written agreement for the coordination of services provided. The findings include: a. Patient #1 had a start of care date of 1/19/22 and diagnoses that included paranoid schizophrenia. The physician’s orders for the certification period of 3/04/25 to 5/02/25 included nursing services twice daily for medication administration and assessments. b. Patient #2 had a start of care date of 6/03/22 and diagnoses that included schizoaffective disorder and post-traumatic stress disorder. The physician’s orders for the certification period of 3/19/25 to 5/17/25 included nursing services twice daily for medication administration and assessments. c. Patient #3 had a start of care date of 5/07/24 and diagnoses that included schizophrenia, seizures, depression and traumatic brain injury. The physician’s orders for the certification period of 3/03/25 to 5/01/25 included nursing services twice daily for medication administration and assessments. Interview and review of Patient’s #1, 2 and 3’s clinical record with the Administrator on 5/12/25 at 1 PM identified twice daily nursing visits for medication administration nursing were provided in the RCH, but failed to identify documented communication/coordination of services between the RCH and the home health agency to define the assignment of primary responsibility for the patient’s care and the frequency of nursing visits. Although requested, there was no policy to review.”

“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 review, review of agency policy and interview with agency personnel, for one of six patients (Patient #4) who received medication management, the agency’s licensed personnel failed to document the pre-pouring process in accordance with agency policies. The findings include: Patient #4 had a start of care date of 10/11/24 and diagnoses that included hypertensive heart disease with failure, atrial fibrillation and congestive heart disease. The physician’s orders for the certification period of 2/08/25 through 4/08/25 included nursing services once a week for assessments and the weekly pre-pouring of medications. Interview and review of RN #1’s nursing notes dated 2/12/25, 2/19/25, 2/26/25 and 3/05/25 with the Administrator on 3/06/25 at 9:30 AM identified documentation of the pre-pouring of the patient’s medications for one week but failed to identify the “date” to “date” that the medications were pre-poured for, and failed to follow agency expectations. Review of agency education for the pre-pour process directed to include intervention details that medications are pre-poured from (date) (am dose, pm dose) to (date) (am dose, pm dose) as per medication profile on the date of the visit.”

“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 one of six patients (Patient #4) who received medication management, the agency nurses failed to follow physician’s orders. The findings include: Patient #5 had a start of care date of 1/29/25 and diagnoses that included autistic disorder and unspecified mood disorder. The physician’s orders dated 1/29/25 included skilled nursing services twice daily for medication administration and the pre-pouring of bedtime medications for self-administration and pre-poring of one set of emergency medications not to be pre-poured any sooner than twenty-four hours before severe inclement weather or emergent event. Interview and review of the clinical record with the Administrator on 3/05/25 at 1 PM identified only one visit was made on 2/05/25 at 9:34 AM and failed to identify the evening visit was conducted for the administration of medications in accordance with physician’s orders.”

“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 review, review of agency policy and interview with agency personnel, for one of seventeen patients (Patient #5) in the survey sample, the agency nurses failed to notify the physician of an alteration in the plan of care. The findings include: Patient #5 had a start of care date of 1/29/25 and diagnoses that included autistic disorder and unspecified mood disorder. The physician’s orders dated 1/29/25 included skilled nursing services twice daily for medication administration and the pre-pouring of bedtime medications for self-administration and pre-pouring of one set of emergency medications not to be pre-poured any sooner than twenty-four hours before severe inclement weather or emergent event. Interview and review of the clinical record with the Administrator on 3/05/25 at 1:15 PM identified only one visit was made on 2/05/25 at 9:34 AM and failed to identify the reason for the missed visit and physician notification of the missed evening visit. Review of agency policy for missed visits directed that the physician must be notified of missed visits and documented in a missed visit note.”

“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: CT #110487 Based on clinical record reviews, review of an agency policy and interview with agency personnel, for one of two patients (Patient #2) who received medication management, the agency’s licensed personnel failed to reconcile medications in accordance with agency policies. The findings include: Patient #2 had a start of care date of 8/21/24 and diagnoses that included sphenoid meningioma resection, epilepsy, encephalopathy and hypertension. The physician’s orders dated 8/21/24 included nursing services once a week for assessments and occupational therapy services. Review of agency documentation dated 10/11/24 identified the Clinical Manager received a call from the next of kin that the patient took the wrong medication last night on 10/10/24, Wellbutrin Sustained Release (an antidepressant) 150 milligrams/mg and indicated that the agency nurse pre-poured the medication into the medication planner incorrectly and indicated that the prescription didn’t belong to the patient. Interview and review of the agency documentation and Registered Nurse/RN #1’s nursing note dated 10/10/24 with the Administrator on 1/15/25 identified on 10/07/24 to 10/08/24, the patient was seen in the Emergency Department/ED after being found on the floor by the next of kin. RN #1 conducted a nursing visit on 10/10/24 at 12:29 PM, indicated that the patient was evaluated at the ED, medications were reconciled, and Wellbutrin was added to the patients medication list, but failed to follow agency policies for medication reconciliation. Review of the agency Medication Reconciliation, Review and Administration directed during a home visit, if the patient reports a new or changed medication, the qualified clinician will verify the medication change with the physician, the label on the bottle of a prescription medication constitutes the pharmacist’s transcription or documentation of the order. Once the medication is verified, the medication is noted in the patient’s medication profile and listed on the plan of care.”

“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: CT #112554 Based on clinical record review, review of agency policies and interviews with agency personnel for one of five patients (Patient #1) in the survey sample, the agency failed to ensure an accurate and authentic record. The findings include: Patient #1 had a start of care date of 12/20/22 and diagnoses that included spastic quadriplegic cerebral palsy, epilepsy, chronic respiratory failure, obstructive sleep apnea, and placement of gastrostomy. The physician’s orders for the certification period of 12/09/24 through 2/06/25 included nursing services up to twenty-two hours a day to assess all health systems, assessment of vital signs, respiratory status, gastrostomy management, check ventilator (bilevel positive airway pressure/BiPAP) and alarm systems during overnight hours, medication administration, with monthly and as-needed nursing supervisory visits. Review of agency documentation dated 1/08/25 identified SCS #1 received a call from the next of kin indicating on 12/23/24 at 7:12 AM, LPN #1, who was working on 12/22/24 from 11 PM-7 AM, left the home without reporting off prior to leaving Patient #1. Furthermore, LPN #1 left at 7:04 AM, observed after the next of kin reviewed an outdoor camera, the next of kin woke up at 7:10 AM, after receiving a phone call. The next of kin went to the patient’s room and found the patient sleeping comfortably. Interview and review of LPN #1’s nursing note dated 12/22/24 at 11 PM – 7AM with the Administrator and SCS on 1/14/25 at 11:55 AM indicated, in the narrative note, that the nurse reported off to the next of kin at the end of the shift and failed to ensure an accurate record due to writing his/her note earlier in the shift and not correcting the note when the situation changed and s/he left the home without reporting off to the next of kin. Review of agency policy for Medical Record Integrity directed all care coordination notes (including but not limited to narrative notes, clinical notes and other coordination notes) shall be a unique account of the agency’s team member’s activities or communication regarding the client’s 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: CT #110487 Based on clinical record review, review of agency policies and interview with agency personnel, for one of five patients (Patient #3) in the survey sample, the agency licensed personnel failed to follow the physician-certified plan of care. The findings include: Patient #3 had a start of care date of 7/31/24 and diagnoses that included schizoaffective disorder. The physician’s orders dated 7/31/24 included nursing services two times a day for medication administration. Physician’s orders included Depakote Delayed Release (used for depression) 500 milligrams/mg with Depakote Delayed Release 250 mg for a total 750 mg twice daily. Review of agency documentation dated 9/03/24 identified the Supervisor of Clinical Services/SCS #2 received a call from the next of kin that the patient had not received Depakote 750 mg twice a day for the past two weeks. Upon investigation by SCS #2 and interview with Registered Nurse/RN #2 on 9/03/24, RN #2 indicated that upon reviewing the bottle of Depakote on 8/29/24, s/he thought the physician was discontinuing the Depakote, as it was ordered for 14 days, and proceeded to discontinue the Depakote on the handwritten Medication Administration Record/MAR in the patient’s lockbox for August 2024 and September 2024. Therefore, the subsequent twice daily nursing visits on 8/29/24 evening visit, 8/30/24, 8/31/24, 9/01/24, 9/02/24 and 9/03/24 (6 days-11 doses) were omitted. On 8/29/24, RN #2 called the physician for clarification of the Depakote order and was instructed not to discontinue the Depakote 750 mg and indicated that the patient’s prescriptions are filled for two weeks at a time to ensure compliance with the physician’s plan of care. The September 2024 MAR was updated by RN #2 but was not placed in the patient’s lockbox, therefore, the subsequent twice daily nursing visits on 8/29/24 evening visit, 8/30/24, 8/31/24, 9/01/24, 9/02/24 and 9/03/24 (6 days-11 doses) were omitted. Interview and review of the agency documentation with the Administrator on 1/15/25 at 12 PM identified that RN #2 failed to follow the physician-certified plan of care. Review of agency policy for Plan of Care directed the plan of care shall be completed in full and include medications, treatments and procedures.”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: CT #112554 Based on clinical record reviews and interviews with agency personnel, for one of three patients (Patient #1) receiving extended hours complex nursing services, and one of two patients (Patient #3) requiring medication management, the agency’s licensed personnel failed to communicate with the caregiver upon departure and/or the licensed personnel involved in a patient’s care plan. The findings include: a. Patient #1 had a start of care date of 12/20/22 and diagnoses that included spastic quadriplegic cerebral palsy, epilepsy, chronic respiratory failure, obstructive sleep apnea, and placement of gastrostomy. The physician’s orders for the certification period of 12/09/24 through 2/06/25 included nursing services up to twenty-two hours a day to assess all health systems, assessment of vital signs, respiratory status, gastrostomy management, check ventilator (bilevel positive airway pressure/BiPAP) and alarm systems during overnight hours, medication administration, with monthly and as-needed nursing supervisory visits. Review of agency documentation dated 1/08/25 identified the Supervisor of Clinical Services/SCS #1 received a call from the next of kin indicating on 12/23/24 at 7:12 AM Licensed Practical Nurse/LPN #1, who was working from 11 PM-7 AM, left the home without reporting off prior to leaving Patient #1. Furthermore, LPN #1 left at 7:04 AM, after reviewing an outdoor camera, the next of kin woke up at 7:10 AM, after receiving a phone call. The next of kin went to the patient’s room and was found sleeping comfortably. i. Interview and review of the agency documentation with the Administrator and SCS on 1/14/25 at 11:15 AM indicated that the agency expectation is to document/communicate with the next of kin or the subsequent shift nurse, if applicable, prior to leaving the home and failed to identify LPN #1 followed agency protocols. b. Patient #3 had a start of care date of 7/31/24 and diagnoses that included schizoaffective disorder. The physician’s orders dated 7/31/24 included nursing services two times a day for medication administration. Physician’s orders included Depakote Delayed Release (used for depression) 500 milligrams/mg with Depakote Delayed Release 250 mg for a total 750 mg twice daily. Review of agency documentation dated 9/03/24 identified the Supervisor of Clinical Services/SCS #2 received a call from the next of kin that the patient had not received Depakote 750 mg twice a day for the past two weeks. Upon investigation by SCS #2 and interview with Registered Nurse/RN #2 on 9/03/24, RN #2 indicated that upon reviewing the bottle of Depakote on 8/29/24, s/he thought the physician was discontinuing the Depakote, as it was ordered for 14 days, and proceeded to discontinue the Depakote on the handwritten Medication Administration Record/MAR in the patient’s lockbox for August 2024 and September 2024. Therefore, the subsequent twice daily nursing visits on 8/29/24 evening visit, 8/30/24, 8/31/24, 9/01/24, 9/02/24 and 9/03/24 (6 days-11 doses) were omitted. On 8/29/24, RN #2 called the physician for clarification of the Depakote order and was instructed not to discontinue the Depakote 750 mg and indicated that the patient’s prescriptions are filled for two weeks at a time to ensure compliance with the physician’s plan of care. ii. Interview and review of the agency documentation with the Administrator on 1/15/25 at 12 PM identified that RN #2 updated the September 2024 MAR but forgot to put it in the patient’s lockbox and failed to identify communication with the subsequent nurses (3 LPN’s) on 8/29/24 evening visit, 8/30/24, 8/31/24, 9/01/24, 9/02/24 and 9/03/24 with the continuation of the Depakote 750 mg twice daily for administration. The physician was notified, and a Depakote level was ordered.”

“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: The agency was out of compliance with the Condition of Participation: 42 CFR 484.55 for Comprehensive Assessment of patients. Based on clinical record review, review of facility documentation, review of agency policies, and interviews, the Agency failed to include pertinent collateral information from referring agencies and patient providers, for the development of patient specific comprehensive assessments, for five (5) of seven (7) patients’ that required daily medication management and nursing assessments, per the agency policy. Refer to G 528 Refer to G 528”

“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: The agency was out of compliance with the Condition of Participation: 42 CFR 484.60 Care Planning, coordination of services, and quality of care. Based on clinical record review, review of facility documentation, review of agency policies, and interviews, the Agency failed to develop comprehensive, individualized care plans for five (5) of seven (7) patients, deemed to have high risk behaviors, as it relates to a transition from a secured intuitional setting to an unsecured community residence. Refer to G 574, G 586, G 608 and G 718 Refer to G 574, G 586, G 608 and G 718”

“Review and revision of the plan of care CFR(s): 484.60(c) Standard: Review and revision of the plan of care. This Standard is not met as evidenced by: Based on clinical record reviews, review of agency’s policies and interviews with agency personnel for five of seven patients (Patient’s #1, 2, 3, 4 and 5), who required medication management for high-risk behaviors, the agency failed to review and revise the care plans for patients deemed to have high risk behaviors. The findings include: a. Patient #1 had an initial intake referral to the home health agency dated 03/27/2023 was for medication management due to non-compliance with a medication regime. Review of Health Care Provider #1’s referral documentation dated 03/27/2023 identified Patient #1 resided in Agency #1 (a secured/supervised residential treatment program providing individualized treatment services for adult males with problem sexual behaviors who are preparing to leave the criminal justice services). Review of the home health agency’s start of care dated 03/28/2023, identified Patient #1 had diagnoses that included, major depressive disorder, unspecified personality disorder, substance use disorder, obesity, and type II diabetes. Review of the home health certification and plan of care dated 03/28/2023, identified the Patient was incarcerated for fourteen years for acts of sexual violence and was deemed to have high risk behaviors. The initial home health nursing assessment dated 03/28/2023, identified Patient #1 resided in Agency #1 and was referred to the home health agency for assistance with successful community re-entry with daily nursing visits for morning medication administration, pre-pouring of the nighttime medications and nursing assessments for medication compliance, and generalized health assessments. Review of Patient #1’s record identified the Patient transitioned from Agency #1 on 08/02/2023 to an unsecured community based transitional residence. The record identified the Patient’s activities were monitored by his/her probation officer by an ankle monitoring system (a device used to track the movement of an individual sentenced to restricted travel/activities). The physician’s orders for the re-certification periods of 07/26/2023 to 09/23/2023 and 09/24/2023 to 11/22/2023, included daily nursing visits for nursing assessments, blood glucose monitoring, morning medication administration, pre-pouring of nighttime medications and ensuing the Patient’s active participation in a targeted recovery plan. Review of Patient #1’s care plans dated 07/21/2023 and 09/19/2023, identified the Patient’s medications would be held and stored in a locked medication box. Review of Patient #1’s nursing note dated 08/04/2023, identified RN Case Manager #2 arrived at the Patient’s community residence and indicated Patient #1 broke into the locked medication box. Patient #1 identified having a change in mood/behavior related to the nurse’s delay in arrival, therefore, broke into the locked medication box to self-administer the morning medications. The nursing note did not identify a health care provider was notified. Review of Patient #1’s coordination notes dated 10/07/2023, 10/08/2023 and 10/14/2023, identified the Patient was not home/unavailable for nursing visits, but did not identify the health care provider was notified of the missed visits, medication administration and pre-pouring of evening medications. Interview with RN Case Manager #2 on 11/15/2023 at 1:00 PM, identified she was assigned as Patient #1’s case manager upon the Patient’s transfer from Agency #1 to an unsecured residence in the community on 08/02/2023, and was not aware of the terms and conditions of the Patient’s probation, and if missed medications and nursing visits needed to be reported to anyone. RN Case Manager #2 further identified the Patient had broken into his/her locked medication box on two occasions, 08/04/2023 and failed to document the date of the second occasion. Record review and interview of Patient #1’s home health nursing care plans dated 07/21/2023 and 09/19/2023 with the Administrator and Regional RN #1 on 11/20/2023 at 12:30 PM, failed to identify the Patient’s care plan was reviewed and revised to reflect a change in Patient #1’s mood/behavior after breaking into locked medication boxes on two separate occasions to self-administer morning medications, and when the Patient missed three scheduled nursing visits resulting in missed medications. b. Patient #2 had a Home Health start of care date of 02/04/2021 with diagnoses that included major depressive disorder, anxiety disorder, unspecified behavioral disorder, and high blood pressure. Review of Patient #2’s start of care nursing summary dated 02/04/2021, identified the Patient had been incarcerated for acts of sexual violence until released to an unsecured residence in the community. The physician’s orders for the re-certification period of 10/19/2023 to 12/17/2023, included daily nursing visits for nursing assessments, morning medication administration and pre-pouring of nighttime medications. Record review and interview of Patient #2 re-certification care plan dated 07/26/2023 with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, the agency failed to identify the Patient’s care plan was reviewed and revised to ensure patient specific safety interventions, access and scheduling for medical and behavioral health providers and access to additional community resources were arranged. c. Patient #3 had a initial Home Health start of care date of 02/11/2021 with diagnoses that included schizophrenia, anxiety disorder, type II diabetes, and high blood pressure. Review of the re-certification nursing summary dated 09/25/2023, identified Patient #3 had been incarcerated for acts of sexual violence and currently resided in a secured/supervised residence in the community. The physician’s orders for the re-certification period of 09/29/2023 to 11/27/2023, included twice daily nursing visits for nursing assessments, blood glucose monitoring and medication administration. Record review and interview of Patient #3 re-certification care plan dated 09/29/2023 with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, the agency failed to identify the Patient’s care plan was reviewed and revised to ensure patient specific safety interventions, access and scheduling for medical and behavioral health providers and access to additional community resources were arranged. d. Patient #4 had a initial start of care date of 9/23/2021 and diagnoses that included unspecified mood disorder, pedophilia, major depressive disorder, antisocial disorder, diabetes mellitus type II, paroxysmal atrial fibrillation, and anxiety. Review of the start of care nursing summary dated 09/23/2021, identified from 7/31/2006 to 9/23/2021, Patient #4 was incarcerated for acts of sexual violence until release to an unsecured residence in the community. The physician’s orders for the re-certification period of 9/13/2023 to 11/11/2023 included nursing services twice daily nursing assessments and medication administration. Record review and interview of Patient #4 re-certification care plan documentation dated 09/29/2023 with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to identify the Patient’s care plan was reviewed and revised to ensure patient specific safety interventions, access and scheduling for medical and behavioral health providers and access to additional community resources were arranged. e. Patient #5 had a start of care date of 10/17/2023 and diagnoses that included bipolar II disorder, antisocial personality disorder, diabetes mellitus type II and hypertension. Review of the start of care nursing summary dated 10/17/2023, identified the Patient was incarcerated for fifteen months for acts of sexual violence and now resided with a next of kin in an unsecured community residence. The physician’s orders dated 10/17/2023 included nursing services once weekly for pre-pouring of medications and nursing assessments. Record review and interview of Patient #5 initial certification care plan documentation dated 10/17/2023 with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to identify the Patient’s care plan was reviewed and revised to ensure patient specific safety interventions, access and scheduling for medical and behavioral health providers and access to additional community resources were arranged Review of the agency’s Admission Process policy identified the agency would identify specific safety measures related to the patient’s vulnerability areas and document the safety measures in the patient’s clinical record and on the care plan. Review of the agency’s Plan of Care policy, identified the plan of care would be based on a comprehensive assessment and information provided by the patient/family and health team members. The plan would be consistently reviewed to ensure that patient needs are met, and would be updated as necessary. The agency professional staff would promptly notify the physician or allowed practitioner of any changes that suggest a need to alter the plan of care. Review of the agency’s Clinical Manager policy identified Clinical Managers would provide oversight of all patient care services and personnel. The oversight would include assuring the development, implementation, and updates of the individualized plan of care.”

“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 clinical record reviews, review of agency’s policies and interviews with agency personnel for five of seven patients (Patient’s #1, 2, 3, 4, and 5) who required daily medication management and nursing assessments for high-risk behaviors, the agency failed to develop patient specific comprehensive assessments that included collateral information from referral sources and patient providers, in accordance with the agency’s policy. The finding includes: a. Patient #1’s initial intake referral to the home health agency dated 03/27/2023 was for medication management and compliance with a medication regime and nursing health assessments. Review of Health Care Provider #1’s referral documentation dated 03/27/2023 identified Patient #1 resided in Agency #1 (a secured/supervised residential treatment program providing individualized treatment services for adult males with problem sexual behaviors who are preparing to leave the criminal justice services). Review of the home health agency’s start of care dated 03/28/2023, identified Patient #1 had diagnoses that included, major depressive disorder, unspecified personality disorder, substance use disorder, obesity, and type II diabetes. Review of the initial home health certification and plan of care dated 03/28/2023, identified the Patient was incarcerated for fourteen years for acts of sexual violence and was deemed to have high risk behaviors. The initial home health nursing assessment dated 03/28/2023, identified Patient #1 resided in Agency #1 and was referred to the home health agency for assistance with successful community re-entry with daily nursing visits for morning medication administration, pre-pouring of the nighttime medications and nursing assessments for medication compliance, and generalized health assessments. Review of Patient #1’s record identified the Patient transitioned from Agency #1 on 08/02/2023 to an unsecured community based transitional residence. The record identified the Patient’s activities were monitored by his/her probation officer by an ankle monitoring system (a device used to track the movement of an individual sentenced to restricted travel/activities). Review of Patient #1’s home health re-certification assessment and plan of care dated for the period of 7/26/23 to 11/22/23 with the Administrator and Regional RN #1 on 11/20/2023 at 12:30 PM, failed to identify the agency performed a comprehensive and accurate reassessment of Patient #1 (deemed to have high risk behaviors), upon transitioning to a new living conditions/environment on 08/02/2023 consisting of assessing the Patient’s immediate and long-term needs, the safety of the new home environment, the Patient’s ability to follow the terms and conditions of probation, ability to independently access community resources such as medical and behavioral health programs, employment, food shopping, transportation and access to psycho/social support systems (family, friends, and recreational activities) to ensure his/her ability to function safely and independently in the community in accordance with the agency’s policy. Review of the agency’s policy for Comprehensive Patient Assessments, identified a comprehensive and accurate assessment would be consistent with the patient’s immediate needs. The assessment identifies facilitating factors and possible barriers to the patient reaching his/her goals including presenting problems. The depth and frequency of ongoing assessments would depend on patient needs, goals and the care treatment and services provided. Reassessments would be conducted based on patient needs, physician orders or professional judgement. b. Patient #2 had a home health start of care date of 02/04/2021 with diagnoses that included major depressive disorder, anxiety disorder, unspecified behavioral disorder, and high blood pressure. Review of Patient #2’s start of care nursing summary dated 02/04/2021, identified the Patient had been incarcerated for acts of sexual violence until released to an unsecured residence in the community. Review of the initial home health certification assessment and plan of care dated dated 02/04/2021 failed to include patient specific collateral information (such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community). Review of the physician’s orders for the re-certification period of 10/19/2023 to 12/17/2023, included daily nursing visits for nursing assessments, morning medication administration and pre-pouring of nighttime medications. Record review and interview of Patient #2’s clinical record with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to identify the agency obtained collateral information (such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community), for the development of Patient #2’s individual care plan as it related to the ability to manage safely and independently with a change in living condition/environment within the community, and failed to ensure the Patient had the resources, to manage in a community environment. Additionally, the agency failed to identify a comprehensive and accurate assessment was performed to reflect the patient’s immediate and long-term care needs, per agency policy. c. Patient #3 had a Home Health start of care date of 02/11/2021 with diagnoses that included schizophrenia, anxiety disorder, type II diabetes, and high blood pressure. Review of the initial start of care nursing assessment summary dated 02/11/2021, identified Patient #3 had been incarcerated for acts of sexual violence and currently resided in a secured/supervised residence in the community. Review of the initial home health certification assessment and plan of care dated 02/11/2021 failed to include patient specific collateral information (such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community). Review of the physician’s orders for the re-certification period of 09/29/2023 to 11/27/2023, included twice daily nursing visits for nursing assessments, blood glucose monitoring and medication administration. Record review and interview of Patient #3’s clinical record with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to identify the agency obtained collateral information ( such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community), for the development of Patient #3’s individual care plan as it related to the ability to manage safely and independently with a change in living condition/environment within the community, and failed to ensure the Patient had the resources, to manage in a community environment. Additionally, the agency failed to identify a comprehensive and accurate assessment was performed to reflect the patient’s immediate and long-term care needs, per agency policy. d. Patient #4 had a start of care date of 9/23/2021 and diagnoses that included unspecified mood disorder, pedophilia, major depressive disorder, antisocial disorder, diabetes mellitus type II, paroxysmal atrial fibrillation, and anxiety. Review of the admission summary dated 09/23/2021, identified Patient #4 was incarcerated for acts of sexual violence until release to an unsecured residence in the community. Review of the home health certification assessment and plan of care dated 09/23/2021 failed to include patient specific collateral information (such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community). Review of the physician’s orders for the re-certification period of 9/13/23 to 11/11/23 included nursing services twice daily nursing assessments and medication administration. Review and interview of Patient #4’s clinical record with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to identify the agency obtained collateral information (such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community), for the development of Patient #4’s individual care plan as it related to the ability to manage safely and independently with a change in living condition/environment within the community, and failed to ensure the Patient had the resources, to manage in a community environment. Additionally, the agency failed to identify a comprehensive and accurate assessment was performed to reflect the patient’s immediate and long-term care needs, per agency policy. e. Patient #5 had a start of care date of 10/17/2023 and diagnoses that included bipolar II disorder, antisocial personality disorder, diabetes mellitus type II and hypertension. Review of the admission summary dated 10/17/2023, identified the Patient was incarcerated for fifteen months for acts of sexual violence and now resided with a next of kin in an unsecured community residence. Review of the home health certification assessment and plan of care dated 10/17/2023 failed to include patient specific collateral information (such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community). Review of the physician’s orders dated 10/17/2023 included nursing services once weekly for pre-pouring of medications and assessments. Review and interview of Patient #5’s clinical record with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to identify the agency obtained collateral information (such as terms and conditions of parole/probation as applicable, for patient’s deemed to have high risks behaviors, access to transportation needs, access to community medical and behavioral health care programs, and ensured the patient safety needs while residing in the community), for the development of Patient #5’s individual care plan as it related to the ability to manage safely and independently with a change in living condition/environment within the community, and failed to ensure the Patient had the resources, to manage in a community environment. Additionally, the agency failed to identify a comprehensive and accurate assessment was performed to reflect the patient’s immediate and long-term care needs, per agency policy. Review of the agency’s policy for Client Admission Process, identified service would not be initiated until an initial assessment had been completed and identified patient needs could be met by the agency. The purpose of the policy would be to ensure the patient’s identifying data was obtained and documented. The admission criteria are standards by which a patient would be deemed appropriate for admission which are the following, the home environment was suitable or adaptable for home care, the patient’s needs could be safely met in the home, if the agency could provide the needed care or services at the level of the intensity the patient’s condition required. The agency would not admit a patient or continue to provide services if the patient’s life situation/caregiver support system does not provide for his/her maintenance/supervision and if the patient’s activities or environment posed a threat to safety of agency personnel. Additionally, the admission professional would assess and document the patient’s vulnerability status and risk for hospitalization and identify specific safety measures relating to the vulnerability area. The safety measure would be documented in the patient’s record and on the care plan as applicable. The applicable, past medical information would be obtained from the transferring/referring organization. Review of the agency’s policy for Coordination of Care Services, identified care conferences would be held as necessary to establish interchange, reporting, and coordinated evaluation between all disciplines involved in the patient’s care. Interdisciplinary care conferences would be conducted as often as needed to respond to changes in the Patient’s needs, services, care and goals. Ongoing care conferences would be conducted to evaluate the patient’s status and progress. Any problems would be discussed, and an action plan developed.”

“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 reviews, review of agency’s policies and interviews with agency personnel for five of seven patients (Patient’s #1, 2, 3, 4 and 5), who required medication management for high-risk behaviors, the agency failed to develop care plans with necessary interventions to address high risk behaviors and failed to implement relevant patient specific psychosocial statuses within the care plans. The finding includes: a. Patient #1’s initial intake referral to the home health agency dated 03/27/2023 was for medication management due to non-compliance with a medication regime. Review of Health Care Provider #1’s referral documentation dated 03/27/2023 identified Patient #1 resided in Agency #1 (a secured/supervised residential treatment program providing individualized treatment services for adult males with problem sexual behaviors who are preparing to leave the criminal justice services). Review of the home health agency’s start of care dated 03/28/2023, identified Patient #1 had diagnoses that included, major depressive disorder, unspecified personality disorder, substance use disorder, obesity, and type II diabetes. Review of the initial home health certification and plan of care dated 03/28/2023, identified the Patient was incarcerated for fourteen years for acts of sexual violence and was deemed to have high risk behaviors. The initial home health nursing assessment dated 03/28/2023, identified Patient #1 resided in Agency #1 and was referred to the home health agency for assistance with successful community re-entry with daily nursing visits for morning medication administration, pre-pouring of the nighttime medications and nursing assessments for medication compliance, and generalized health assessments. Review of Patient #1’s record identified the Patient transitioned from Agency #1 on 08/02/2023 to an unsecured community based transitional residence. The record identified the Patient’s activities were monitored by his/her probation officer by an ankle monitoring system (a device used to track the movement of an individual sentenced to restricted travel/activities). The physician’s orders for the re-certification periods of 07/26/2023 to 09/23/2023 and 09/24/2023 to 11/22/2023, included daily nursing visits for nursing assessments, blood glucose monitoring, morning medication administration, pre-pouring of nighttime medications and ensuing the Patient’s active participation in a targeted recovery plan. Review of Patient #1’s care plans related to major depressive disorder, personality disorder and substance use disorder, dated 07/21/2023 and 09/19/2023, failed to include collaboration with community providers in the development and implementation of a targeted recovery plan. The care plans failed to include patient specific interventions of the targeted recovery plan and the Patient’s specific psychosocial status such as interpersonal relationships, transportation needs, vocational needs, and household/homemaker needs. Record review and interview with the Administrator and Regional RN #1 on 11/20/2023 at 12:30 PM, failed to provide documentation to support collaboration with community referral sources and addressed the Patient’s psychosocial needs. b. Patient #2 had a Home Health start of care date of 02/04/2021 with diagnoses that included major depressive disorder, anxiety disorder, unspecified behavioral disorder, substance use disorder and high blood pressure. Review of Patient #2’s home health start of care nursing assessment summary dated 02/04/2021, identified the Patient had been incarcerated for acts of sexual violence until released to an unsecured residence in the community. The physician’s orders for the re-certification period of 10/19/2023 to 12/17/2023, included daily nursing visits for nursing assessments, morning medication administration, pre-pouring of nighttime medications and ensuring the Patient’s active participation in the targeted recovery plan, Review of Patient #2’s care plan related to major depressive disorder, anxiety disorder, unspecified behavioral disorder and substance use disorder dated 10/16/2023, failed to include collaboration with community providers in the development and implementation of a targeted recovery plan. The care plan failed to include patient specific interventions of the targeted recovery plan and the Patient’s specific psychosocial status such as interpersonal relationships, transportation needs, vocational needs and household/homemaker needs. Record review and interview with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to provide documentation to support collaboration with community referral sources and addressed the Patient’s psychosocial needs. c. Patient #3 had a Home Health start of care date of 02/11/2021 with diagnoses that included schizophrenia, anxiety disorder, type II diabetes, and high blood pressure. Review of the home health re-certification nursing assessment summary dated 09/25/2023, identified Patient #3 had been incarcerated for acts of sexual violence and currently resided in a secured/supervised residence in the community. The physician’s orders for the re-certification period of 09/29/2023 to 11/27/2023, included twice daily nursing visits for nursing assessments, blood glucose monitoring and medication administration. Review of Patient #3’s care plan related to schizophrenia and anxiety disorder dated 09/25/2023, failed to include collaboration with community providers in the development and implementation of a patient specific care plan. The care plan failed to include the Patient’s specific psychosocial status such as interpersonal relationships, transportation needs, vocational needs, and household/homemaker needs. Record review and interview with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to provide documentation to support collaboration with community referral sources and addressed the Patient’s psychosocial needs. d. Patient #4 had an initial start of care date of 9/23/2021 and diagnoses that included unspecified mood disorder, substance use disorder, pedophilia, major depressive disorder, antisocial personality disorder, anxiety, diabetes mellitus type II, and paroxysmal atrial fibrillation. Review of the home health start of care nursing assessment summary dated 09/23/2021, identified Patient #4 was incarcerated for acts of sexual violence until release to an unsecured residence in the community. The physician’s orders for the re-certification period of 9/13/2023 to 11/11/2023 included nursing services twice daily nursing assessments and medication administration. Review of Patient #4’s care plan related to unspecified mood disorder, substance use disorder, major depressive disorder, antisocial personality disorder and anxiety dated 09/08/2023, failed to include collaboration with community providers in the development and implementation of a targeted recovery plan. The care plans failed to include patient specific interventions of the targeted recovery plan and the Patient’s specific psychosocial status such as interpersonal relationships, transportation needs, vocational needs, and household/homemaker needs. Record review and interview with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, failed to provide documentation to support collaboration with community referral sources and addressed the Patient’s psychosocial needs. e. Patient #5 had a start of care date of 10/17/2023 and diagnoses that included bipolar II disorder, antisocial personality disorder, diabetes mellitus type II and hypertension. Review of the start of care nursing assessment summary dated 10/17/2023, identified the Patient was incarcerated for fifteen months for acts of sexual violence and now resided with a next of kin in an unsecured community residence. The physician’s orders dated 10/17/2023 included nursing services once weekly for pre-pouring of medications and nursing assessments. Review of Patient #5’s care plan related to bipolar II disorder, antisocial personality disorder, diabetes mellitus type II and hypertension dated 10/17/2023, failed to include collaboration with community providers in the development and implementation of a patient specific care plan. The care plan failed to include the Patient’s specific psychosocial status such as interpersonal relationships, transportation needs, vocational needs, and household/homemaker needs. Review of a coordination of care nurse’s noted dated 11/15/23 by RN #3 identified due to the Patient’s history of sexual assault with a female, no female nurses will be assigned to Patient #5 for weekly medication administration. Record review and interview with the Administrator and Regional RN #1 on 11/20/2023 at 12:40 PM, identified the initial care plan dated 10/17/2023 failed to identify that due to the Patient’s specific sexual assault history, female nurses would not be assigned to Patient #5 for weekly medication administration. Additionally, the agency failed to provide documentation to support collaboration with community referral sources, and address the Patient’s psychosocial needs. Review of the agency’s Admission Process policy identified the agency would identify specific safety measures related to the patient’s vulnerability areas and document the safety measures in the patient’s clinical record and on the care plan. Review of the agency’s Plan of Care policy, identified the plan of care would be based on a comprehensive assessment and information provided by the patient/family and health team members. The plan would be consistently reviewed to ensure that patient needs are met and would be updated as necessary. The agency professional staff would promptly notify the physician or practitioner of any changes that suggest a need to alter the plan of care. Review of the agency’s Clinical Manager policy identified Clinical Managers would provide oversight of all patient care services and personnel. The oversight would include assuring the development, implementation, and updates of the individualized plan of care.”

“Coordinate care delivery CFR(s): 484.60(d)(4) Coordinate care delivery to meet the patient’s needs, and involve the patient, representative (if any), and caregiver(s), as appropriate, in the coordination of care activities. This Element is not met as evidenced by: Based on clinical record reviews, review of agency policies, and interviews with agency personnel for one of seven patients (Patient’s #1) who required medication management for high-risk behaviors, the agency failed to ensure coordination of care delivery between the referring agency and the Home Health agency to meet the patient’s needs. The finding includes: Patient #1’s initial intake referral to the home health agency dated 03/27/2023 was for medication management due to non-compliance with a medication regime. Review of Health Care Provider #1’s referral documentation dated 03/27/2023 identified Patient #1 resided in Agency #1 (a secured/supervised residential treatment program providing individualized treatment services for adult males with problem sexual behaviors who are preparing to leave the criminal justice services). Review of the home health agency’s start of care dated 03/28/2023, identified Patient #1 had diagnoses that included, major depressive disorder, unspecified personality disorder, substance use disorder, obesity, and type II diabetes. Review of the home health certification and plan of care dated 03/28/2023, identified the Patient was incarcerated for fourteen years for acts of sexual violence and was deemed to have high risk behaviors. The initial home health nursing assessment dated 03/28/2023, identified Patient #1 resided in Agency #1 and was referred to the home health agency for assistance with successful community re-entry with daily nursing visits for morning medication administration, pre-pouring of the nighttime medications and nursing assessments for medication compliance, and generalized health assessments. Review of Patient #1’s record identified the Patient transitioned from Agency #1 on 08/02/2023 to an unsecured community based transitional residence. The record identified the Patient’s activities were monitored by his/her probation officer by an ankle monitoring system (a device used to track the movement of an individual sentenced to restricted travel/activities). The agency failed to identify coordination of care occurred between Agency #1 and the home health agency by obtaining patient specific collateral information, such as the terms and conditions of the Patient’s probation, ability to independently access community resources such as medical and behavioral health programs, employment, food shopping, transportation and access to psycho/social support systems (family, friends, and recreational activities) to ensure his/her ability to function safely and independently in the community. Interview with RN Case Manager #2 on 11/15/2023 at 1:00 PM, identified she was assigned as Patient #1’s case manager upon the Patient’s transfer from Agency #1 to an unsecured residence in the community on 08/02/2023. RN Case Manager #2 was not aware of the terms and conditions of Patient #1’s probation or if the Patient had been referred to a community based behavioral health program for outpatient therapy and psychiatric medication management. RN Case Manager #2 further identified in October 2023; the Patient attempted to make appointments at a community behavioral health program but was unable to obtain an appointment until 11/01/2023. Review of the agency’s Coordination of Patient Services policy, identified all personnel furnishing services would ensure that their efforts are coordinated effectively and support the objective outlined in the plan of care. The coordination of care delivered to meet the patient’s needs, and involve the patient, representative (if any) as appropriate in the coordination of care activities. Review of the agency’s Clinical Manager policy identified Clinical Managers would provide oversight of all patient care services and personnel. The oversight would include coordinating referrals and assuring the development, implementation and updates of the individualized plan of care.”

“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 seven patients (Patient’s #1) who required medication management for high-risk behaviors, the agency failed to notify the patient’s health care provider of a change in mood/behavior, non-compliance with nursing visits and the need for a Social Work consult to ensure continuity of care and access to community resources, for a patient transitioning from a secured treatment facility to an unsecured community residence. The findings included: Patient #1’s initial intake referral to the home health agency dated 03/27/2023 was for medication management due to non-compliance with a medication regime. Review of Health Care Provider #1’s referral documentation dated 03/27/2023 identified Patient #1 resided in Agency #1 (a secured/supervised residential treatment program providing individualized treatment services for adult males with problem sexual behaviors who are preparing to leave the criminal justice services). Review of the home health agency’s start of care dated 03/28/2023, identified Patient #1 had diagnoses that included, major depressive disorder, unspecified personality disorder, substance use disorder, obesity, and type II diabetes. Review of the initial home health certification and plan of care dated 03/28/2023, identified the Patient was incarcerated for fourteen years for acts of sexual violence and was deemed to have high risk behaviors. The initial home health nursing assessment dated 03/28/2023, identified Patient #1 resided in Agency #1 and was referred to the home health agency for assistance with successful community re-entry with daily nursing visits for morning medication administration, pre-pouring of the nighttime medications and nursing assessments for medication compliance, and generalized health assessments. Review of Patient #1’s record identified the Patient transitioned from Agency #1 on 08/02/2023 to an unsecured community based transitional residence. The record identified the Patient’s activities were monitored by his/her probation officer by an ankle monitoring system (a device used to track the movement of an individual sentenced to restricted travel/activities). The physician’s orders for the re-certification periods of 07/26/2023 to 09/23/2023 and 09/24/2023 to 11/22/2023, included daily nursing visits for nursing assessments, blood glucose monitoring, morning medication administration, pre-pouring of nighttime medications and ensuring the Patient’s active participation in a targeted recovery plan Review of Patient #1’s nursing note dated 08/04/2023, identified RN Case Manager #2 arrived at the Patient’s community residence and indicated Patient #1 broke into the locked medication box. Patient #1 had a change in mood/behavior related to the nurse’s delay in arrival, therefore, broke into the locked medication box to self-administer the morning medications. The nursing note did not identify a health care provider was notified. Review of Patient #1’s coordination notes dated 10/07/2023, 10/08/2023 and 10/14/2023, identified the Patient was not home/unavailable for nursing visits but did not identify the health care provider was notified of the missed visits. The agency failed to identify the Patient’s health care provider was notified when Patient # 1 broke into the locked medication box on two occasions as a result of a change in mood/behavior, and of three missed nursing visits on 10/07/2023, 10/08/2023 and 10/14/2023 resulting in the Patient not receiving morning and nighttime pre-poured medications, and of the need for a Medical Social Work (MSW) consult to assist the Patient with accessing community medical and behavioral health programs and community resources. Interview with RN Case Manager #2 on 11/15/2023 at 1:00 PM, identified she was assigned as Patient #1’s case manager upon the Patient’s transfer from Agency #1 to an unsecured residence in the community on 08/02/2023. RN Case Manager #2 identified the Patient had broken into his/her locked medication box on two occasions 08/04/2023, but was unable to recall the date of the second incident, and failed to document the occurrence in the Patient’s clinical record. RN Case Manager #2 indicated she was not aware if Patient #1 had been referred to a community based behavioral health program for outpatient therapy and psychiatric medication management. RN Case Manager #2 further identified in October 2023, the Patient attempted to make appointments at a community behavioral health program, but was unable to obtain an appointment until 11/01/2023. Record review and interview of Patient #1’s clinical record with the Administrator and Regional RN #1 on 11/15/2023 at 1:20 PM, identified being aware Patient #1 broke into his/her locked medication box on two occasions as a result of a change in mood/behavior and of Patient # 1’s missed nursing visits on three (3) occasions. The Administrator identified Patient #1’s health care provider was not notified when Patient #1 broke into his/her medication box on two occasions, as RN Case Manager #2 has provided medication safety teaching to the Patient after the incidences. The Administrator further indicated, although she was aware of Patient #1’s three missed nursing visits, she was unaware the health care provider was not notified in accordance with the agency’s policy. Additionally, the agency failed to provide documentation to support Patient #1’s health care provider was notified of the need for a MSW consult to assess the Patient’s adjustment to care in the community setting, to assess the availability of community resources and to provide counseling services to the Patient on a short-term basis. Review of the agency’s Clinical Manager policy identified Clinical Managers would provide oversight of all patient care services and personnel. The oversight would include coordinating referrals. Review of the agency’s Medical Social Services policy, identified a referral for Medical Social Services may include but is not limited to assessing the social and emotional factors related to the patient’s illness, need for care, response to treatment and adjustment to care, assessing the relationship of the patient’s medical and nursing needs to the home situation and availability of community resources. Medical Social Service can provide counseling services to the patient on a short-term basis to address situations/circumstances that are impediments to the effective treatment of the patient. Review of the agency’s Missed Visit Best Practices identified the patient’s physician must be notified of missed visits and documented. Review of the agency’s Coordination of Patient Services policy, identified the coordination of care delivered would meet the patient’s needs, and involve the patient, representative (if any) as appropriate in the coordination of care activities.”