Caresphere, LLC

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on review of observations, clinical records, and an interview with the agency owner, it was determined that the agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including provision of optimal care to achieve the goals and outcomes identified in the patient’s plan of care. This CONDITION is not met as evidenced under the following standards: Cross Reference: 484.105(b)(2) (Tag 952): Ensure the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies 484.105(c) (Tag 958): Clinical Manager The cumulative effect of these systematic problems resulted in the agency’s inability to ensure the provision of quality healthcare to the patients.”

“Licensing CFR(s): 484.100(b) (b) Standard: Licensing. The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered, as applicable, in accordance with the state licensing authority as meeting those requirements. This Standard is not met as evidenced by: Based on observations and interview with agency staff, the agency failed to provide access to documentation needed to conduct a complaint investigation. Findings include: Upon arrival at the agency location at 1 East Broad Street, Suite 430, Bethlehem, PA 18018, on May 21, 2025, at 10:00 A.M., the only agency staff present in the office was the office assistant. The surveyors explained to the office assistant that they were on-site to conduct a complaint investigation and would like to speak to the agency owner, administrator, or the director of nursing. The office assistant placed a call to the agency owner at approximately 10:15 A.M. The surveyors requested that the director of nursing or the administrator come to the office to assist with the complaint investigation. The agency owner stated that the director of nursing quit without notice a couple of weeks ago and the owner was conducting interviews in New York. The surveyors requested that the administrator come to the office, but the agency owner repeatedly refused, stating the agency owner would come to the office instead. The surveyors requested the following documentation: a complaint log, a list of agency clients, and a list of agency staff. The agency owner stated she would send documentation to the office assistant to print for the surveyors. The surveyors requested access to the agency’s electronic medical record (EMR). The surveyors were told that the agency owner would provide access to the EMR. The lists of agency clients and staff were received at approximately 10:30 A.M. Neither the subject of the complaint, nor the agency staff member listed in the complaint, were on the lists provided. Another call was placed to the agency owner at approximately 10:45 A.M. The agency owner was asked specifically about the subject of the complaint. The agency owner informed the surveyors that the subject of the complaint was a patient under the home health (skilled) agency. The complaint intake form listed the subject of the complaint as a client of the home care (non-medical) agency. Another list was requested for the skilled patients and staff. The surveyors also requested the incident report and investigation for the incident. A second request was made for access to the EMR. The agency owner stated that she cancelled the interviews and was traveling to the agency office. Once there, the agency owner stated that she will go through the EMR with the surveyors. The agency owner arrived at the office location at approximately 12:45 P.M. Additional documentation was requested on May 30, 2025, and received on June 2, 2025. An interview with the agency owner on May 21, 2025, and email communications on May 22, 2025, and June 2, 2025, confirmed the above findings. *Repeat deficiency from survey conducted January 31, 2025”

“Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This Standard is not met as evidenced by: Based on a review of agency job descriptions, text and email messages, and an interview with the agency owner, the governing body failed to ensure a qualified registered nurse (RN) was hired for the position of Clinical Manager /Supervising nurse. Findings include: On May 21, 2025, at approximately 11:00 A.M., a review of the agency job description titled “Clinical Manager/Supervising Nurse” revealed the following: “Qualifications: Education & Training: 1. A licensed physician, physical therapist, speech-language pathologist, occupational therapist, audiologist, social worker, or registered nurse with a minimum of one (1) year of nursing experience… “ On May 21, 2025, at approximately 2:45 P.M., during an interview with the owner, she reported that the Clinical Manager quit without notice on May 5, 2025. The agency owner stated, “I had interviews scheduled today, but then you people showed up.” The agency owner stated that there is no one else qualified to be the director of nursing at this time. On May 22, 2025, at approximately 10:00 A.M., an email was received from the agency owner. Attached were a copy of a text message and an email from the director of nursing. The text message was dated May 5, 2025, and stated, “… I completed my in person visit… I going to finish his charting today… I’m going to move forward with my decision…” The email dated May 5, 2025, stated, “I’m writing to let you know I’ve made the difficult decision to resign from my position, as of today…” The agency owner noted in the email that two (2) new nurses will be starting on June 2, 2025, and July 7, 2025. Both nurses have more than a year of nursing experience, as required. The agency owner stated that she will decide which nurse would be best suited for the clinical supervisor role. As of June 5, 2025, no documentation has been received from the agency regarding the hiring of a clinical manager. An interview with the agency owner on May 21, 2025, and email communications on May 22, 2025, and June 2, 2025, confirmed the above findings. *Repeat deficiency from survey conducted January 31, 2025”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on a review of agency policy, clinical records (CR), and an interview with the agency owner, the agency failed to ensure a registered nurse (RN) completed a comprehensive assessment for two (2) of four (4) CR reviewed. (CR #1 and 2) Findings include: Review of agency Policy titled ‘Comprehensive Patient Assessments’ on May 21, 2025, at approximately 12:00 P.M. states, “Procedure: 1. Comprehensive Assessment Requirements: … The assessment must be completed by an RN only; The assessment must be completed in person; The assessment must include: The completion of a full head-to-toe assessment…” Review of clinical records (CR) on May 21, 2025, from approximately 1:00 P.M. to 3:00 P.M. revealed the following: CR #1, start of care April 4, 2025, contained a ‘Home Health Certification and Plan of Care’ (POC) for certification period April 4, 2025, through June 2, 2025. The initial comprehensive assessment completed by the RN on April 4, 2025, did not contain vital signs (blood pressure, pulse, respirations, and/or temperature). The RN documented, “Vitals not obtained, patient is under non-skilled maintenance care. Caregiver instructed to follow up with PCP (primary care physician) for routine vital signs and report changes.” CR #2, start of care March 31, 2025, contained a POC for certification period March 31, 2025, through May 29, 2025. The initial comprehensive assessment completed by the RN on March 31, 2025, did not contain vital signs. The RN documented, “[CR #2] vitals not obtained, patient is under non-skilled maintenance care. Caregiver instructed to follow up with PCP for routine vital signs and report changes.” An interview with the agency owner on May 21, 2025, and email communications on May 22, 2025, and June 2, 2025, confirmed the above findings. *Repeat deficiency from survey conducted January 31, 2025”

“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 a review of agency policy, review of clinical records, and an interview with the agency owner, the agency failed to ensure the patient’s plan of care covered all required elements for four (4) of four (4) clinical records (CR) reviewed (CR#1, 2, 3, 4). Findings include: Agency policy/procedure was reviewed on May 21, 2025, at approximately 12:00 P.M. Policy #C2.0: “Acceptance of Patients, Plan of Care, and Medical Supervision’ ‘Procedure’ (2) states “Plan of Care’ (B) The Plan of Care includes: ...... (v) The frequency and duration of visits to be made... x. All medications and treatments...” A review of CRs conducted on May 21, 2025, at approximately 1:00 P.M. and completed on June 5, 2025, at approximately 2:00 P.M. revealed the following: CR #1, start of care April 4, 2025, contained a ‘Home Health Certification and Plan of Care’ (POC) for certification period April 4, 2025, through June 2, 2025. ‘Orders for Discipline and Treatments’ listed Aide: 5-7/Week x 9 weeks. The POC did not contain the number of hours care is to be provided daily. CR #2, start of care March 31, 2025, contained a POC for certification period March 31, 2025, through May 29, 2025. ‘Orders for Discipline and Treatments’ listed Aide: 4-5/Week x 9 Week(s)… Home health visit up to 40 hours a week during school days. Assist with dressing (1-7), nail care (1-5), Bath-Tub (1-5), Housekeeping-kitchen (1-7), Housekeeping-bathroom (1-7). The POC did not contain orders for the number of hours care is to be provided daily. Services listed are not services that would be provided while in school. CR #3, start of care March 25, 2025, contained a POC for certification period March 25, 2025, through May 23, 2025. ‘Orders for Discipline and Treatments’ listed Home Health Aide: up to 7 days a week for 9 weeks; Authorization approved for 20 hours flex a week for help with all ADL activities. The orders do not specify care to be provided. CR #4 (subject of the complaint), start of care June 8, 2022, contained a POC for certification period March 28, 2025, through May 23, 2025. ‘Orders for Discipline and Treatments’ list Aide: 3-5/Week x 9 Week(s). The POC did not contain orders for the number of hours care is to be provided daily. An interview with the agency owner on May 21, 2025, and email communications on May 22, 2025, and June 2, 2025, confirmed the above findings. *Repeat deficiency from survey conducted January 31, 2025”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on a review of clinical records and an interview with the agency owner, the agency failed to provide documentation that all patient care was provided as ordered in the plan of care for two (2) of four (4) clinical records (CR) reviewed (CR#1 and 4) Findings include: Review of clinical records (CR) on May 21, 2025, from approximately 1:00 P.M. to 3:00 P.M. revealed the following: CR #1, start of care April 4, 2025, contained a ‘Home Health Certification and Plan of Care’ (POC) for certification period April 4, 2025, through June 2, 2025. ‘Orders for Discipline and Treatments’ listed Aide: 5-7/Week x 9 weeks. The POC did not contain the number of hours care is to be provided daily. Missed visits were documented on April 7, and 17, 2025, and May 10 and 19, 2025. There was no documentation that the attending physician was notified of the missed visits. CR #4 (subject of the complaint), start of care June 8, 2022, contained a POC for certification period March 28, 2025, through May 23, 2025. ‘Orders for Discipline and Treatments’ list Aide: 3-5/Week x 9 Week(s). The POC did not contain orders for the number of hours care is to be provided daily. There were multiple open shifts documented on the missed visit report. No care was provided on April 9, 16, and 23, 2025, due to no staffing available. No care was provided on April 28 and 30, 2025, and May 2, 7, 8, 9, and 12, 2025. The missed visits were documented as family declined services. There was no documentation that the attending physician was notified of the missed visits. An interview with the agency owner on May 21, 2025, and email communications on May 22, 2025, and June 2, 2025, confirmed the above findings.”

“Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This Element is not met as evidenced by: Based on a review of agency policy, incident reports, drug testing results, and an interview with the agency owner, the agency failed to follow their policy related to substance abuse for one (1) of four (4) PF reviewed. (PF #4). Findings include: Review of agency policy titled “Alcohol/Drugs” on May 21, 2025, at approximately 11:45 A.M. states, “1. Zero Tolerance for Substance Use: CareSphere has a zero-tolerance policy for the use of illegal drugs or the misuse of prescription drugs while on duty. 2. Impairment and Caregiving: Caregivers must not be under the influence of alcohol or any substances that impair their ability to provide safe and effective care. 6. Drug Testing: CareSphere may conduct random drug tests to ensure the safety and well-being of our clients. Caregivers are required to comply with these tests if requested. 7. Legal Implications: Caregivers must be aware that substance use on the job can have serious legal consequences and may result in immediate termination.” Review of an incident report dated April 9, 2025, at 8:00 A.M., revealed that a caregiver, personnel file (PF) #4, arrived at school to provide care for consumer record (CR) #4. Two (2) administrative personnel from the school alleged that the odor of marijuana was coming from PF #4’s clothing. The police were called, and PF #4 was detained and taken to the police station. Review of two (2) urine drug screening tests dated April 15, 2025, and May 10, 2025, documented positive test results for marijuana metabolite. PF #4 was permitted to return to work on April 21, 2025. Allowing PF #4 to return to work is in violation of the agency’s policy regarding use of illegal drugs and being under the influence of any substances that impair their ability to provide safe and effective care. An interview with the agency owner on May 21, 2025, and email communications on May 22, 2025, and June 2, 2025, confirmed the above findings.”

“Comprehensive Assessment of Patients CFR(s): 484.55 Condition of participation: Comprehensive assessment of patients. Each patient must receive, and an HHA must provide, a patient-specific, comprehensive assessment. For Medicare beneficiaries, the HHA must verify the patient’s eligibility for the Medicare home health benefit including homebound status, both at the time of the initial assessment visit and at the time of the comprehensive assessment. This Condition is not met as evidenced by: Based on review of agency policies/procedures, clinical records, and an interview with the agency Administrator, it was determined that the agency failed to ensure a registered nurse conducted the initial evaluation, completed a comprehensive assessment, review all medications, and update the comprehensive assessment the last 5 days of every 60 days. This CONDITION is not met as evidenced under the following standards: Cross Reference: 484.55.(a)(1) (Tag 514): Initial assessment visit 484.55(b)(1) (Tag 520): Completion of the comprehensive assessment 484.55(c)(5) (Tag 536): Review of all medications the patient is currently using to identify any potential averse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. 484.55(d) (Tag 544): Update of Comprehensive Assessment 484.55(d)(1) (Tag 546) Update of the comprehensive assessment the last 5 days of every 60 days beginning with the start-of-care date The cumulative effect of these systematic problems resulted in the agency’s inability to ensure the provision of quality healthcare to the patients.”

“Care planning, coordination, quality of care CFR(s): 484.60 Condition of participation: Care planning, coordination of services, and quality of care. Patients are accepted for treatment on the reasonable expectation that an HHA can meet the patient’s medical, nursing, rehabilitative, and social needs in his or her place of residence. Each patient must receive an individualized written plan of care, including any revisions or additions. The individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care. The individualized plan of care must also specify the patient and caregiver education and training. Services must be furnished in accordance with accepted standards of practice. This Condition is not met as evidenced by: Based on review of agency policies/procedures, clinical records, and an interview with the agency Administrator, it was determined that the agency failed to ensure patient’s received appropriate care planning, coordination of services, and quality of care. This CONDITION is not met as evidenced under the following standards: Cross Reference: 484.60(a)(2) (Tag 574): Content of the plan of care 484.60(b) (Tag 580) Conformance with the physician orders 484.60(d) (Tag 588) Review and revision of the plan of care The cumulative effect of these systematic problems resulted in the agency’s inability to ensure the provision of quality healthcare to the patients.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on review of observations, clinical records, and an interview with the agency Administrator, it was determined that the agency failed to organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including provision of optimal care to achieve the goals and outcomes identified in the patient’s plan of care. This CONDITION is not met as evidenced under the following standards: Cross Reference: 484.105(b)(2) (Tag 952): Ensure the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies 484.105(c) (Tag 958): Clinical Manager 484.105(c)(4) (Tag 966): Clinical manager assures that patient needs are continually assessed The cumulative effect of these systematic problems resulted in the agency’s inability to ensure the provision of quality healthcare to the patients.”

“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 agency policy, review of clinical records, and an interview with the agency’s Administrator, the agency failed to follow its own policy and ensure that staff completed a comprehensive assessment visit at least every sixty (60) days or as often as the patients condition changed for seven (7) of the seven (7) clinical records (CR) reviewed (CR#1-CR#7). Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 pm. Policy #C-3.0 ‘Comprehensive Assessment of Patients and Coordination of Care’ ‘Procedure’ … 4. Update of the Comprehensive Assessment: A RN or the appropriate clinician, updates and revises the comprehensive assessment regularly (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: A. The last 5 days of every 60 days beginning with the start-of-care date (recertification period…” A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm, revealed the following: CR #1 SOC (start of care) 8/26/24 contained a document titled “Assessment” dated 9/27/24. No additional reassessment documentation was provided. CR #2, SOC 1/18/24 contained documents dated 6/20/24 and 9/11/24, which noted the visit type as “Reassessment”. There was no documentation of vital signs or head to toe assessment. The RN documented that the visits were “virtual visits”. The HHA eXchange Calendar contained documentation of a tele visit by the RN on 11/25/24. There was no “Assessment” document provided for the 11/25/24 RN visit. No additional reassessment documentation was provided. CR #3 SOC 8/18/2020: contained “Assessment” documents dated 6/20/24 and 9/11/24. There was no documentation of vital signs or head to toe assessment. The HHA eXchange Calendar contained documentation of a tele visit by the RN on 11/14/24. There was no “Assessment” document provided for the 11/14/24 RN visit. No additional reassessment documentation was provided. CR #4 SOC 8/14/23 contained no documentation of reassessment visits conducted. CR#5 SOC 11/21/24: contained an “Assessment” document dated 11/21/24, which did not include documentation of vital signs or head-to-toe assessment. The HHA eXchange Calendar labeled it as a (T) tele visit. No additional reassessment documentation was provided. CR#6 SOC 4/11/24 contained an “Assessment” document dated 6/10/2024 which contained no documentation of vital signs or head-to-toe assessment. The HHA eXchange Calendar labeled it as a (T) tele visit. The RN documented this as a “virtual nursing assessment” on the “Assessment” document. CR#7 SOC 6/30/23 contained no documentation of reassessment visits conducted. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“Licensing CFR(s): 484.100(b) (b) Standard: Licensing. The HHA, its branches, and all persons furnishing services to patients must be licensed, certified, or registered, as applicable, in accordance with the state licensing authority as meeting those requirements. This Standard is not met as evidenced by: Based on observations and interview with agency staff, the agency failed to provide access to documentation needed to conduct a State re-licensure survey. Findings include: Upon arrival at the agency location at 1 East Broad Street, Suite 430, Bethlehem, PA 18018, on Tuesday, 1/7/25, at 10:00 am, the door to the office was locked. A telephone call was placed to the agency number on record at 9:44 am. A message voice message was left for the agency administrator to contact the surveyor regarding an on-site survey for State re-licensure. A telephone call was placed to an alternate telephone number on record for the agency. The agency owner answered the telephone and stated that the office would be open and staff available on Wednesday, 1/8/25 at 10:00 am for the surveyor to conduct the survey. The agency owner stated that the office is open Monday through Thursday, 10:00 am to 2:00 pm. The Administrator, the Alternate Administrator, nor the Clinical Manager were available for the survey on Tuesday, 1/8/25. On Wednesday 1/8/25 at 10:30 am, a list of documentation required to conduct the re-licensure survey was provided to the agency Owner. The surveyor requested access to the agency’s electronic medical record (EMR) to review clinical records as required by State and Federal survey requirements. The agency owner stated she could not grant access to the EMR due to “privacy concerns”. Some of the clinical records (CR) and personnel files (PF) were printed for the surveyor while on-site at the agency office. Additional CR and PF were emailed to the surveyor after the on-site survey was completed. Multiple requests were made for documentation during the on-site survey, and in multiple follow-up emails to the agency owner and administrator. The surveyor was not able to obtain comprehensive visit notes, initial and recertification assessments for the CR chosen for the survey. Requests were made for PF documentation that was not provided during the on-site survey. The missing PF documentation was not provided via email. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“Clinical manager CFR(s): 484.105(c) Standard: Clinical manager. One or more qualified individuals must provide oversight of all patient care services and personnel. Oversight must include the following-- This Standard is not met as evidenced by: Based on a review of agency job descriptions, employee files (EF) files, and an interview with the agency owner and the administrator, the governing body and the administrator failed to ensure a qualified registered nurse (RN) was hired for the position of Clinical Manager /Supervising nurse. Findings included: On January 13, 2025, at approximately 11:00 am., a review of the agency job description titled “Registered Nurse” revealed the following: “Education and Experience: 2. Experience: Minimum one (1) year of clinical nursing experience; home health experience preferred. On January 8, 2025, at approximately 12pm, during an interview with the owner, she reported that “EF#1 is the “Supervisory Nurse” for the agency. On January 9, 2025, at approximately 10 am, reviewed the agency’s organizational chart which lists EF#1 as “Clinical Manager/Supervising Nurse.” A review of EFs was conducted on January 8, 2025, at approximately 11:30 am and on January 17, 2025, at approximately 10 am revealed the following: EF #1, Date of hire (DOH) 9/23/24: Contained a Virginia State Registered Nurse (RN) multistate license. The RN license was issued on 9/4/2024. There was no documentation that the Clinical Manager/Supervising nurse met the qualifications for supervising nurse under 28 Pa. Code, Part IV, Health Facilities, and Subpart G. Chapter 601 and agency policy. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient’s return home, or on the physician or allowed practitioner - ordered start of care date. This Element is not met as evidenced by: Based on a review of agency policy, review of clinical records, and an interview with the agency’s Administrator, the agency failed to follow its own policy and ensure that a registered nurse (RN) conducts the initial assessment/comprehensive assessment visit for seven (7) of the seven (7) clinical records (CR) reviewed (CR#1-CR#7). Based on a review of agency policy, review of clinical records, and an interview with the agency’s Administrator, the agency failed to follow its own policy and ensure that a registered nurse (RN) conducts the initial assessment/comprehensive assessment visit for seven (7) of the seven (7) clinical records (CR) reviewed (CR#1-CR#7). Agency policy reviewed on January 31, 2025, at approximately 1:00 p.m. Policy # C-1.0 “Referral, Intake Process and Assessment Visit” Admission/Intake Visit #2 “The RN or therapist conducts the initial patient assessment visit, or when delegated by the Senior Director/Executive Director or Clinical Manager and ordered by the referring the physician….” C. “The Admission Consent Form is reviewed with the patient, family and/or their legal guardian/legal representative…” Comprehensive Assessment, Development of the Plan of Treatment/Care and Care Coordination/ Management 1. “As part of the intake/admission assessment visit, patients admitted to Caresphere receive a patient specific comprehensive assessment at the start of care completed by the RN or Therapist...” and Policy # C-3.0 “Comprehensive Assessment of Patients and Coordination of Care” 4. Content of Discipline-Specific Comprehensive Assessments. “The Nursing Comprehensive Assessment includes, but is not limited to: A. Patient Information…. ii. Vital signs…viii. Head to toe assessment…” A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm, revealed the following: CR #1 SOC (start of care) 8/26/24. The “Referral” document did not contain a date that the referral was received by the agency, or a physician requested start of care date. A document titled “Assessment” dated 9/27/24, one (1) month after the SOC, noted the “Visit Type” as “Initial Evaluation and Start of Care”. There was no documentation of a comprehensive assessment completed at the start of care on 8/26/24. The assessment completed on 9/27/24 contained no documentation of vital signs or a head-to-toe assessment. The HHA eXchange (time keeping system utilized by the agency) Calendar labeled the visit on 9/27/24 as a (T) tele visit. CR #2, SOC 1/18/24. The “Referral” document did not contain a date that the referral was received by the agency, or a physician requested start of care date. There was no documentation of an initial comprehensive assessment completed at the start of care. CR #3 SOC 8/18/2020. The “Referral” document did not contain a date that the referral was received by the agency, or a physician requested start of care date. There was no documentation of an initial comprehensive assessment completed at the start of care. CR #4 SOC 8/14/23. The “Referral” document did not contain a date that the referral was received by the agency, or a physician requested start of care date. There was no documentation of an initial comprehensive assessment completed at the start of care. CR#5 SOC 11/21/24: The “Referral” document did not contain a date that the referral was received by the agency, or a physician requested start of care date. An “Assessment” document dated 11/21/24 did not include documentation of vital signs or head-to-toe assessment. The HHA eXchange Calendar labeled it as a (T) tele visit. CR#6 SOC 4/11/24. The CR contained a referral dated 2/12/24. Consents were signed 2/16/24. There was no documentation of an initial comprehensive assessment completed at the start of care. CR#7 SOC 6/30/23. No referral document was provided. An “Assessment” was documented on 5/1/23, which was sixty-one (61) days before the start of care. There was no documentation an initial comprehensive assessment completed on 6/30/23 at the start of care. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“5 calendar days after start of care CFR(s): 484.55(b)(1) The comprehensive assessment must be completed in a timely manner, consistent with the patient’s immediate needs, but no later than 5 calendar days after the start of care. This Element is not met as evidenced by: Based on a review of agency policy/procedure, a review of patient clinical records (CR), and an interview with the agency Administrator, the agency failed to ensure a comprehensive assessment was conducted no later than (5) calendar days after the start of care for seven (7) out of seven (7) CR reviewed (CR#1-CR#7). Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 pm. Policy #C-3.0 “Comprehensive Assessment of Patients and Coordination of Care’ ‘Procedure” (1) states “Completion of the Comprehensive Assessment: Patients admitted to the Caresphere receive a patient specific comprehensive assessment at the start of care completed by a RN, LPN, or a Physical or Occupational Therapist or Speech Language Pathologist.” (A) states “The RN, LPN or appropriate therapy discipline ....... completes the comprehensive assessment consistent with the patients immediate needs, no later than 5 calendar days after the start of care. The start of care date is the date of the initial assessment, and the comprehensive assessment must be completed within 5 calendar days of that date.” A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm revealed the following: CR#1 SOC 8/26/24: Certification period reviewed 12/23/24-2/19/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. The initial visit conducted by the RN on 8/26/24 was a “virtual” visit by (PF#2), which was not comprehensive. No vital signs or head to toe assessment were documented. CR#2 SOC 8/18/20: Certification period reviewed 11/14/24-1/11/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. CR#3 SOC 1/18/24: Certification period reviewed 11/13/24-1/10/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. CR#4 SOC 8/14/23: Certification period reviewed 12/6/24-2/2/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. CR#5 SOC 11/21/24: Certification period reviewed 11/21/21-1/18/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. The initial visit on 11/21/24 was a “virtual” visit by (PF#1), which was not comprehensive. No vital signs or head to toe assessment were documented. CR#6 SOC 4/11/24: Certification period reviewed 12/7/24-2/3/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. CR#7 SOC 6/30/23: Certification period reviewed 4/24/23-6/23/24 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on a review of agency policy/ procedure, clinical records (CR), and an interview with the agency’s Administrator, the agency failed to provide documentation showing staff completed evaluations of all patient medications per policy including but not limited to: any potential adverse effects, any drug reactions including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy for seven (7) seven (7) clinical records reviewed. (CR#1-CR#7). Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 pm. The policy titled, Policy # C-3.0 “Comprehensive Assessment of Patients and Coordination of Care” #3 Content of Comprehensive Assessment E states, “A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy and noncompliance with drug therapy.” A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm revealed the following: CR#1 SOC (start of care) 8/26/24: Certification period reviewed 12/23/24-2/19/25 contained no documentation that medications were reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. CR#2 SOC 8/18/20: Certification period reviewed 11/14/24-1/11/25 contained no documentation that medications were reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. CR#3 SOC 1/18/24: Certification period reviewed 11/13/24-1/10/25 contained no documentation that medications were reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. CR#4 SOC 8/14/23: Certification period reviewed 12/6/24-2/2/25 contained no documentation that medications were reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. CR#5 SOC 11/21/24: Certification period reviewed 11/21/21-1/18/25 contained no documentation that medications were reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. CR#6 SOC 4/11/24: Certification period reviewed 12/7/24-2/3/25 contained no documentation that medications were reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. CR#7 SOC 6/30/23: Certification period reviewed 4/24/23-6/23/24 contained no documentation that medications were reviewed for potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“Last 5 days of every 60 days unless: CFR(s): 484.55(d)(1)(i,ii,iii) The last 5 days of every 60 days beginning with the start-of-care date, unless there is a- (i) Beneficiary elected transfer; (ii) Significant change in condition; or (iii) Discharge and return to the same HHA during the 60-day episode. This Element is not met as evidenced by: Based on a review of agency policy/procedure, a review of patient clinical records (CR), and an interview with the agency Administrator, the agency failed to ensure that a reassessment occurred within the last five (5) days of every sixty (60) day recertification period for seven (7) of seven (7) CR’s reviewed. (CR#1- CR#7) Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 pm. Policy #C-3.0 ‘Comprehensive Assessment of Patients and Coordination of Care’ ‘Procedure’ … 4. Update of the Comprehensive Assessment: A RN or the appropriate clinician, updates and revises the comprehensive assessment regularly (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: A. The last 5 days of every 60 days beginning with the start-of-care date (recertification period…” A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm revealed the following: The patient’s start of care (SOC) is listed below. CR#1 SOC 8/26/24: Certification period reviewed 12/23/24-2/19/25 contained no documentation of a comprehensive assessment by the RN in the last five (5) days of each 60-day certification period. CR#2 SOC 8/18/20: Certification period reviewed 11/14/24-1/11/25 contained no documentation of a comprehensive assessment by the RN in the last five (5) days of each 60-day certification period. CR#3 SOC 1/18/24: Certification period reviewed 11/13/24-1/10/25 contained no documentation of a comprehensive assessment by the RN in the last five (5) days of each 60-day certification period. CR#4 SOC 8/14/23: Certification period reviewed 12/6/24-2/2/25 contained no documentation of a comprehensive assessment by the RN in the last five (5) days of each 60-day certification period. CR#5 SOC 11/21/24: Certification period reviewed 11/21/21-1/18/25 contained no documentation of a comprehensive assessment by the RN in the last five (5) days of each 60-day certification period. CR#6 SOC 4/11/24: Certification period reviewed 12/7/24-2/3/25 contained no documentation of a comprehensive assessment by the RN in the last five (5) days of each 60-day certification period. CR#7 SOC 6/30/23: Certification period reviewed 4/24/23-6/23/24 contained no documentation of a comprehensive assessment by the RN in the last five (5) days of each 60-day certification period. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“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 a review of agency policy, review of clinical records, and an interview with the agency Administrator, the agency failed to ensure the patient’s plan of care covered all required elements including but not limited to: specific interventions to be provided by the staff skilled and non-skilled, duration of services for seven (7) of seven (7) clinical records (CR) reviewed (CR#1-CR#7). Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 p.m. Policy #C2.0: “Acceptance of Patients, Plan of Care, and Medical Supervision’ ‘Procedure’ (2) states “Plan of Care’ (B) The Plan of Care includes: ...... (v) The frequency and duration of visits to be made… x. All medications and treatments…” A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm revealed the following: CR#1 SOC (start of care) 8/26/24: Certification period reviewed 12/23/24-2/19/25. The “Home Health Certification and Plan of Care” (POC) ‘Orders for Discipline and Treatments’ were as follows: [Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. HHA (home health aide) 70 hours per week, 5 hours per day on school days Monday, Wednesday, and Friday, and 10 hours on non-school days; he is currently doing school from home on Tuesdays and Thursdays so will need 10 home health aide hours those days as well as Saturday and Sunday. The total hours should be 55 to 70 hours per week. There was no duration of service indicated in this order for the RN or the HHA. CR#2 SOC 8/18/20: Certification period reviewed 11/14/24-1/11/25. The POC ‘Orders for Discipline and Treatments’ were as follow: [Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. [Non-Skilled Nursing] HHA 55 hours a week home health aide 40 hours a week and 10 to 15 hours a week to be there when Mya gets home from school so that mother can have time to get home and do her schoolwork. There was no duration of service indicated in this order for the RN or the HHA. The “Medications” section of the POC contained a hand-written medication, Flonase (nasal spray) 2 sprays each nare (nostril) daily. There was no documentation of the date or person adding the hand-written medication to the POC. CR#3 SOC 1/18/24: Certification period reviewed 11/13/24-1/10/. The POC ‘Orders for Discipline and Treatments’ were as follows: [Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. [Non-Skilled] HHA 40 hours per week home health aide services, 40 hours per week, Monday to Friday, up to 8 hours per day to allow her mother to work. There was no duration of service indicated in this order for the RN or the HHA. CR#4 SOC 8/14/23: Certification period reviewed 12/6/24-2/2/25. ‘Orders for Discipline and Treatments’ were as follows: Standard Orders: Registered Nurse scheduled at least every 60 days per regulatory requirements for routine assessment, treatment evaluation and oversight. SN 50 hrs/wk (hours per week) skilled nursing at home care Monday through Friday from 7:30 a.m. to 5:30 p.m. while his parents are at work. [Non-skilled] SN 50 hrs/wk skilled nursing at home care Monday through Friday from 7:30 a.m. to 5:30 p.m. while his parents are at work. ‘Non-skilled’ nursing is not a recognized discipline. There was no duration of service indicated for the RN or the SN. The POC contained order for glucose levels to be monitored throughout the day with Dexcom device along with use of Glucometer 5-10 times daily. The orders for insulin were as follows: “Humalog 100 U/ML (units per milliliter) up to 100 Units suspension subcutaneous injection as directed via pump, Humalog Junior Kwikpen 100 U/ML up to 50 units per sliding scale suspension subcutaneous injection as directed, Lantus100 U/ML use up to 30 units daily solution subcutaneous injection PRN (as needed) Use up to 30 Units when not using insulin pump.” There were no parameters for a sliding scale for the administration of the insulin. No documentation that the nurse contacted the physician to clarify the order, CR#5 SOC 11/21/24: Certification period reviewed 11/21/21-1/18/25. ‘Orders for Discipline and Treatments’ were as follows: “STANDARD ORDERS: [SKILLED NURSING] Registered nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory purposes. HHA: 40 hours per week home health aide 40 hours per week.” There was no duration of service indicated for the RN or the HHA. CR#6 SOC 4/11/24: Certification period reviewed 12/7/24-2/3/25. ‘Orders for Discipline and Treatments’ were as follows: [SKILLED NURSING]: Registered nurse to perform assessment every 60 days for regulatory guidance, for routine oversight, assessment, treatment evaluation and supervisory purposes… [NON SKILLED] Note entered 11/22/24. Auth from 11/10/24-03/01/25 Weekly: Up to 236 units. SUN-SAT Total: up to 3776 units LCD: 03/01/25…” There was no duration of service indicated for the RN. There was no clarification on duration and frequency of HHA services. CR#7 SOC 6/30/23: Certification period reviewed 4/24/23-6/23/24. ‘Orders for Discipline and Treatments were as follows: “[SKILLED NURSING] Registered nurse scheduled at least every 60 days per regulatory guidelines for routine assessment, treatment evaluation, supervisory, and oversight. Aide: In Person (1-5)” There was no duration of service indicated for the RN and no duration and frequency for the HHA. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This Element is not met as evidenced by: Based on a review of agency policy, review of clinical records, and an interview with the agency Administrator, the agency failed to provide documentation that all patient care was provided as ordered in the plan of care for seven (7) of seven (7) clinical records (CR) reviewed (CR#1-CR#7). Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 p.m. No policies were provided pertaining to documentation of care provided. A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm revealed the following: CR#1 SOC (start of care) 8/26/24: Certification period reviewed 12/23/24-2/19/25. The “Home Health Certification and Plan of Care” (POC) ‘Orders for Discipline and Treatments’ were as follows: “[Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. HHA (home health aide) 70 hours per week, 5 hours per day on school days Monday, Wednesday, and Friday, and 10 hours on non-school days…” There was no documentation that the RN completed a visit every 60 days. There was no documentation of the services provided by the HHA, only the electronic time keeping via HHA eXchange. CR#2 SOC 8/18/20: Certification period reviewed 11/14/24-1/11/25. The POC ‘Orders for Discipline and Treatments’ were as follow: “[Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. [Non-Skilled Nursing] HHA 55 hours a week home health aide 40 hours a week and 10 to 15 hours a week to be there when Mya gets home from school…” There was no documentation that the RN completed a visit every 60 days. There was no documentation of the services provided by the HHA, only the electronic time keeping via HHA eXchange. CR#3 SOC 1/18/24: Certification period reviewed 11/13/24-1/10/. The POC ‘Orders for Discipline and Treatments’ were as follows: “[Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. [Non-Skilled] HHA 40 hours per week home health aide services, 40 hours per week, Monday to Friday, up to 8 hours per day to allow her mother to work.” There was no documentation that the RN completed a visit every 60 days. There was no documentation of the services provided by the HHA, only the electronic time keeping via HHA eXchange. CR#4 SOC 8/14/23: Certification period reviewed 12/6/24-2/2/25. ‘Orders for Discipline and Treatments’ were as follows: “Standard Orders: Registered Nurse scheduled at least every 60 days per regulatory requirements for routine assessment, treatment evaluation and oversight. SN 50 hrs/wk (hours per week) skilled nursing at home care Monday through Friday from 7:30 a.m. to 5:30 p.m. while his parents are at work. [Non-skilled] SN 50 hrs/wk skilled nursing at home care Monday through Friday from 7:30 a.m. to 5:30 p.m. while his parents are at work The POC contained order for glucose levels to be monitored throughout the day with Dexcom device along with use of Glucometer 5-10 times daily. The orders for insulin were as follows: “Humalog 100 U/ML (units per milliliter) up to 100 Units suspension subcutaneous injection as directed via pump, Humalog Junior KwikPen 100 U/ML up to 50 units per sliding scale suspension subcutaneous injection as directed, Lantus100 U/ML use up to 30 units daily solution subcutaneous injection PRN (as needed) Use up to 30 Units when not using insulin pump.” There were no parameters for a sliding scale for the administration of the insulin. There was no documentation the nurse contacted the physician to clarify the order. There was no documentation that the RN completed a visit every 60 days. There was no documentation of the services provided by the skilled nurse, only the electronic time keeping via HHA eXchange. CR#5 SOC 11/21/24: Certification period reviewed 11/21/21-1/18/25. ‘Orders for Discipline and Treatments’ were as follows: “STANDARD ORDERS: [SKILLED NURSING] Registered nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory purposes. HHA: 40 hours per week home health aide 40 hours per week.” There was no duration of service indicated for the RN or the HHA. CR#6 SOC 4/11/24: Certification period reviewed 12/7/24-2/3/25. ‘Orders for Discipline and Treatments’ were as follows: “[SKILLED NURSING]: Registered nurse to perform assessment every 60 days for regulatory guidance, for routine oversight, assessment, treatment evaluation and supervisory purposes… [NON SKILLED] Note entered 11/22/24. Auth from 11/10/24-03/01/25 Weekly: Up to 236 units. SUN-SAT Total: up to 3776 units LCD: 03/01/25…” There was no duration of service indicated for the RN. There was no clarification on duration and frequency of HHA services. There was no duration of service indicated for the RN or the HHA. CR#7 SOC 6/30/23: Certification period reviewed 4/24/23-6/23/24. ‘Orders for Discipline and Treatments were as follows: “[SKILLED NURSING] Registered nurse scheduled at least every 60 days per regulatory guidelines for routine assessment, treatment evaluation, supervisory, and oversight. Aide: In Person (1-5)” There was no duration of service indicated for the RN and no duration and frequency for the HHA. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“Reviewed, revised by physician every 60 days CFR(s): 484.60(c)(1) The individualized plan of care must be reviewed and revised by the physician or allowed practitioner who is responsible for the home health plan of care and the HHA as frequently as the patient’s condition or needs require, but no less frequently than once every 60 days, beginning with the start of care date. This Element is not met as evidenced by: Based on a review of agency policy, review of clinical records, and an interview with the agency Administrator, the agency failed to ensure the physician reviewed and revised the plan of care no less frequently than once every 60 days for three (3) of seven (7) clinical records (CR) reviewed (CR#4, 5, and 7). Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 p.m. Policy #C2.0: “Acceptance of Patients, Plan of Care, and Medical Supervision’ ‘Procedure’ 4. Case Management, Review of Patient Care Plans and Summary Reports, A. Plan of Care: ii. All clinical staff, the Clinical Manager must communicate promptly with the attending or relevant physician(s) who is responsible for the patient’s individualized home health plan of care at the following times regarding the plan of care and need to alter it: 1) As often as the severity of the patient’s condition requires. 2) At least once every sixty (60) days, beginning with the start-of-care date, in order to review and revise the plan of care.” A review of CRs was conducted on 1/9/25, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm revealed the following: CR#4 SOC 8/14/23: The POC for the initial certification period 8/14/23, through 10/12/23, was signed by the physician on 1/31/24, more than five (5) months after the start of the certification period. The POC for the certification period 10/13/23, through 12/11/23, was signed by the physician 12/19/23, two (2) months after the start of the certification period. The POC for the certification period 2/20/24, through 4/9/24, was signed by the physician 6/14/24, four (4) months after the start of the certification period. CR#5 SOC 11/21/24: The POC for certification period 11/21/21-1/18/25 was not signed by the physician as of 1/31/2025, more than two (2) months after the start of the certification period. CR#7 SOC 6/30/23: The POC for certification period 4/24/23-6/23/24 was signed by the physician on 6/14/24, two (2) months after the start of the certification period. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, — (A) The registered nurse must make an onsite, in person visit every 60 days to assess the quality of care and services provided by the home health aide and to ensure that services meet the patient’s needs; and (B) The home health aide does not need to be present during this visit. (ii) Semi-annually the registered nurse must make an on-site visit to the location where each patient is receiving care in order to observe and assess each home health aide while he or she is performing non-skilled care This Element is not met as evidenced by: Based on a review of clinical records (CR), and an interview with the administrator, the agency failed to maintain documentation of supervisory visits of the LPN (licensed practical nurse) and HHA (Home Health Aide) by a RN (Registered Nurse) in accordance with the plan of treatment for five (5) out of the seven (7) CRs reviewed. (#CR#2, CR#3, CR#4 CR#6, and CR#7) Findings include: A review of CRs was conducted on January 9, 2025, at approximately 10 am to 2pm and completed on January 31, 2025, at approximately 1 pm revealed the following: CR#2 SOC 8/18/20: Certification period reviewed 11/14/24-1/11/25. The POC ‘Orders for Discipline and Treatments’ were as follows: [Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. [Non-Skilled Nursing] HHA 55 hours a week home health aide 40 hours a week and 10 to 15 hours a week to be there when Mya gets home from school so that mother can have time to get home and do her schoolwork. There was no duration of service indicated in this order for the RN or the HHA. There was no documentation of any onsite supervision of the HHA performed by an RN provided as requested by email on January 10, 2025, at 9:01 am CR#3 SOC 1/18/24: Certification period reviewed 11/13/24-1/10/. The POC ‘Orders for Discipline and Treatments’ were as follows: [Skilled Nursing] Registered Nurse scheduled at least every 60 days per regulatory guidelines for routine oversight, assessment, treatment evaluation, and supervisory. [Non-Skilled] HHA 40 hours per week home health aide services, 40 hours per week, Monday to Friday, up to 8 hours per day to allow her mother to work. There was no duration of service indicated in this order for the RN or the HHA. There was no documentation of any onsite supervision of the HHA performed by an RN provided as requested by email on January 10, 2025, at 9:01 am. CR#4 SOC 8/14/23: Certification period reviewed 12/6/24-2/2/25. ‘Orders for Discipline and Treatments’ were as follows: Standard Orders: Registered Nurse scheduled at least every 60 days per regulatory requirements for routine assessment, treatment evaluation and oversight. SN 50 hrs/wk (hours per week) skilled nursing at home care Monday through Friday from 7:30 a.m. to 5:30 p.m. while his parents are at work. [Non-skilled] SN 50 hrs/wk skilled nursing at home care Monday through Friday from 7:30 a.m. to 5:30 p.m. while his parents are at work. ‘Non-skilled’ nursing is not a recognized discipline. There was no duration of service indicated for the RN or the SN. The POC contained order for glucose levels to be monitored throughout the day with Dexcom device along with use of Glucometer 5-10 times daily. The orders for insulin were as follows: “Humalog 100 U/ML (units per milliliter) up to 100 Units suspension subcutaneous injection as directed via pump, Humalog Junior Kwikpen 100 U/ML up to 50 units per sliding scale suspension subcutaneous injection as directed, Lantus100 U/ML use up to 30 units daily solution subcutaneous injection PRN (as needed) Use up to 30 Units when not using insulin pump.” There were no parameters for a sliding scale for the administration of the insulin. There was no duration of service indicated for the RN or the HHA. There was no documentation of any onsite supervision of the LPN performed by an RN provided as requested by email on January 10, 2025, at 9:01 am. CR#6 SOC 4/11/24: Certification period reviewed 12/7/24-2/3/25. ‘Orders for Discipline and Treatments’ were as follows: [SKILLED NURSING]: Registered nurse to perform assessment every 60 days for regulatory guidance, for routine oversight, assessment, treatment evaluation and supervisory purposes… [NON SKILLED] Note entered 11/22/24. Auth from 11/10/24-03/01/25 Weekly: Up to 236 units. SUN-SAT Total: up to 3776 units LCD: 03/01/25…” There was no duration of service indicated for the RN. There was no clarification on duration and frequency of HHA services. There was no documentation of any onsite supervision of the HHA performed by an RN provided as requested by email on January 10, 2025, at 9:01 am. CR#7 SOC 6/30/23: Certification period reviewed 4/24/23-6/23/24. ‘Orders for Discipline and Treatments were as follows: “[SKILLED NURSING] Registered nurse scheduled at least every 60 days per regulatory guidelines for routine assessment, treatment evaluation, supervisory, and oversight. Aide: In Person (1-5)” There was no duration of service indicated for the RN and no duration and frequency for the HHA. There was no documentation of any onsite supervision of the HHA performed by an RN was provided as requested by email on January 10, 2025, at 9:01 am. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”

“Ensure that HHA employs qualified personnel CFR(s): 484.105(b)(1)(iv) (iv) Ensure that the HHA employs qualified personnel, including assuring the development of personnel qualifications and policies. This Element is not met as evidenced by: Based on a review of agency policy, a review of child protective state law, a review of employee files, a review of the Center for Disease Guidelines, and an interview with the agency Administrator, the agency failed to follow its own policy and state law to conduct a state, federal, and child line background checks upon hire for two (2) out of nine (9) employee files; the agency failed to ensure that employees were screened for mycobacterium tuberculosis (TB) upon hire for one (1) out of nine (9) employee files; and the agency failed to conduct performance evaluation as per their policy for three (3) out of nine (9) employee files (EF) reviewed (EF#1, EF#2, EF#3, EF#4, and EF#8 ) Findings include: Agency policy/procedure was reviewed on January 9, 2025, at approximately 10:00 am. Policy HR07 titled “Background Checks” Procedure states “Criminal Background checks are required for all employees. The background checks must be completed, and the results verified before any employee begins work….” State police “Caresphere will conduct the criminal history background check via Pennsylvania State Police Criminal Repository for all employees before hire….” On January 17, 2025, at approximately 10:30 am reviewed “The Child Protective Services Law” Title 23 Pa. CS., Chapter 63 Section 6344 states “…require any prospective employee engaging in an occupation with a significant likelihood of regular contact with children, in the form of care, guidance, supervision or training to obtain…” On January 17, 2025, at approximately 11 am reviewed “CDC Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in health-care settings, 2005. Morbidity and Mortality World Report 2005; RR-17” The CDC guidelines state “…all Health Care Workers (HCW) should receive baseline tuberculosis screening upon hire, using a two-step tuberculin skin test (TST) or a single blood assay for tuberculosis (TB) to test for infection with tuberculosis. After baseline testing for infection with tuberculosis, HCWs should receive TB screening annually. HCWs with a baseline positive or newly positive test for tuberculosis infections should receive one chest radiograph result to exclude tuberculosis disease.” (http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf.) *Baseline (preplacement) screening and testing, in addition to the IGRA (interferon-gamma release assay) or TST, shall include a symptom screen questionnaire and an individual TB risk assessment. Serial screening and testing not routinely recommended. Annual TB education is recommended. (CDC/MMWR/May 17, 2019/Vol. 68/No. 19). On January 17, 2025, at approximately 11:30 am reviewed Policy #HR-12.0 titled “Core Competency Skills/Employee performance Criteria” Employee Performance Criteria 1. states “Agency personnel will demonstrate proficiency in the performance criteria/skills during their orientation period, at least annually thereafter, as part of the annual performance evaluation…” A review of EFs was conducted on January 8, 2025, at approximately 11:30 am to 2 pm and on January 17, 2025, at approximately 10 am revealed the following: EF#1 Date of hire (DOH) 9/23/24: Contained no documentation to demonstrate proficiency in the performance criteria/skills during the orientation period. EF#2 DOH 6/14/2024: Contained documentation of a QuantiFERON Gold plus dated 6/30/24, after the hire date. Contained no documentation to demonstrate proficiency in the performance criteria/skills during the orientation period. EF#3 DOH 8/11/23: No documentation that a Pennsylvania State Police Criminal History (PATCH) was conducted upon hire. PATCH dated 8/16/23 was conducted after the employee was in contact with a minor (CR#4) on 8/14/2023. EF#4 DOH 10/17/23: Contained no documentation to demonstrate proficiency in the performance criteria/skills during the orientation period. EF#8, DOH 8/2824: Did not contain documentation of a ChildLine verification or a Federal history check with fingerprints upon hire. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings. *Repeat deficiency 02/03/22 survey”

“Assure patient needs are continually assessed CFR(s): 484.105(c)(4) Assuring that patient needs are continually assessed, and This Element is not met as evidenced by: Based on a review of agency policy/procedure, a review of patient clinical records (CR), and an interview with the agency Administrator, the agency failed to ensure a registered nurse (RN) made the initial evaluation visit and initiated the plan of treatment, regularly reevaluated the patient’s nursing needs made necessary revisions to the plan of treatment for seven (7) out of seven (7) CR reviewed (CR#1-CR#7). Findings include: Agency policy/procedure was reviewed on January 31, 2025, at approximately 1:00 pm. Policy #C-1.0 “Referral, Intake Process and Assessment Visit’ ‘Policy’ states “The initial visit is conducted by a Registered Nurse (RN) or a qualified Therapist.” Policy #C-3.0 ‘Comprehensive Assessment of Patients and Coordination of Care’ ‘Procedure’ (1) states “Completion of the Comprehensive Assessment: Patients admitted to the Caresphere receive a patient specific comprehensive assessment at the start of care completed by a RN, LPN, or a Physical or Occupational Therapist or Speech Language Pathologist.” (A) states “The RN, LPN or appropriate therapy discipline ....... completes the comprehensive assessment consistent with the patients immediate needs, no later than 5 calendar days after the start of care. The start of care date is the date of the initial assessment and the comprehensive assessment must be completed within 5 calendar days of that date… 4. Update of the Comprehensive Assessment: A RN or the appropriate clinician, updates and revises the comprehensive assessment regularly (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: A. The last 5 days of every 60 days beginning with the start-of-care date (recertification period) …” A review of CRs was conducted on January 9, 2025, at approximately 10 am and completed on January 31, 2025, at approximately 1 pm revealed the following: CR#1 SOC 8/26/24: Certification period reviewed 12/23/24-2/19/25 contained no documentation of a comprehensive assessment by the RN. The initial visit on 8/26/24 was a “virtual” visit by (PF#2), which was not comprehensive. No vital signs or head to toe assessment were documented. There was no documentation provided that indicated the RN conducted regular visits every 60 days to reevaluate the patient’s needs. CR#2 SOC 8/18/20: Certification period reviewed 11/14/24-1/11/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. There was no documentation provided that indicated that the RN conducted regular visits every 60 days to reevaluate the patient’s needs. CR#3 SOC 1/18/24: Certification period reviewed 11/13/24-1/10/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. There was no documentation provided that indicated that the RN conducted regular visits every 60 days to reevaluate the patient’s needs. CR#4 SOC 8/14/23: Certification period reviewed 12/6/24-2/2/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. There was no documentation provided that indicated that the RN conducted regular visits every 60 days to reevaluate the patient’s needs. CR#5 SOC 11/21/24: Certification period reviewed 11/21/21-1/18/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. The initial visit on 11/21/24 was a “virtual” visit by (PF#1), which was not comprehensive. No vital signs or head to toe assessment were documented. There was no documentation provided that indicated that the RN conducted regular visits every 60 days to reevaluate the patient’s needs. CR#6 SOC 4/11/24: Certification period reviewed 12/7/24-2/3/25 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. There was no documentation provided that indicated that the RN conducted regular visits every 60 days to reevaluate the patient’s needs. CR#7 SOC 5/6/23: Certification period reviewed 4/24/23-6/23/24 contained no documentation of a comprehensive assessment completed within five (5) calendar days of the SOC. A copy of the initial comprehensive assessment was requested on January 10, 2025, at 9:01 am. No documentation of initial or comprehensive assessment was provided. There was no documentation provided that indicated that the RN conducted regular visits every 60 days to reevaluate the patient’s needs. An interview with the Administrator on January 31, 2025, via telephone at approximately 2 pm confirmed the above findings.”