Home Care Wellness, LLC

“Skilled professional services CFR(s): 484.75 Condition of participation: Skilled professional services. Skilled professional services include skilled nursing services, physical therapy, speech-language pathology services, and occupational therapy, as specified in §409.44 of this chapter, and physician or allowed practitioner and medical social work services as specified in §409.45 of this chapter. Skilled professionals who provide services to HHA patients directly or under arrangement must participate in the coordination of care. This Condition is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the Registered Nurse followed accepted standards of practice in assuming responsibility for the care in 1 (P-11) of 2 patients requiring LPN supervision, from a total of 17 sampled patient records reviewed (See G 704); failed to incorporate safety parameters in the Plan of Care (POC) concerning congestive heart failure exacerbation along with failure to update the POC with the patient after a resumption of care (ROC) visit in 1 (P-12) of 3 patients reviewed with a ROC visit (See G 708); failed to provide services as ordered in the POC in 1 (P-11) of 3 transferred records reviewed (See G 710); and failed to communicate with the physician pertaining to ordered services not being provided after hospital discharge in 1 (P-11) of 3 transferred records reviewed out of a total sample of 17 records (See G 718). The cumulative effect of these systemic problems resulted in the home health agency’s inability to ensure the provision of quality health care in a safe environment for the condition of participation of 42 CFR 484.75, Skilled Professional Services.”

“EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to provide documentation that it had participated in the community based full-scale exercise required every two years, resulting in the potential for patients and staff not to be properly prepared in the event of an actual emergency. Findings include: On 9/12/24 at 09:35 AM., review of the Agency’s Emergency Preparedness binder found no evidence the Agency had conducted the required full-scale community-based exercise every two years. No communication or effort was noted by the Agency in reaching out to the local incident command center to participate in the community-based exercise for the last 3 years. The above findings were reviewed with and acknowledged by the Alternate Administrator (Adm #2) and the Director of Clinical Services (DCS #1) during an interview on 9/12/24 at 12:45 PM.”

“Performance improvement projects CFR(s): 484.65(d)(1)(2) Standard: Performance improvement projects. Beginning July 13, 2018 HHAs must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity, and past performance of the HHA’s services and operations. (2) The HHA must document the quality improvement projects undertaken, the reasons for conducting these projects, and the measurable progress achieved on these projects. This Standard is not met as evidenced by: Based on interview and record review, it was determined the Agency failed to develop Performance Improvement activities, as part of the Agency’s Quality Assessment Performance Improvement program, in order to track and trend adverse patient events, analyze the cause and implement preventive interventions, resulting in the potential for the rendering of substandard care and unmet care needs. Findings include: On 9/12/24 at 11:05 a.m., the Agency’s QAPI (Quality Assessment Performance Improvement) documents were reviewed. The provided binder contained data from patient complaints, infection control reports and information from chart audits. There was no documentation of any Performance Improvement Projects based on the above collected data. When asked to review the agency’s Performance Improvement Projects for the current and previous years, the Alternate Administrator/CEO (Adm #2) reviewed the documents in the binder and reported, “I agree with you. I don’t see anything in the binder, but I can look in the hard drive.” On 9/12/24 at 3:00 p.m., Adm #2 stated, “I uploaded the Performance Improvement Project for your review. We had one on wound care. When asked to review the previous projects, Adm #2 was unable to provide them as requested. The agency failed to establish ongoing Performance Improvement Projects as a way to track and trend adverse patient events. These findings were acknowledged at the time of the 3:00 p.m. interview.”

“Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This Standard is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure its disciplines utilized Infection Control standards of practice during the provision of care and services for 2 (P-3, P-4) of 2 patients observed during home visits from a total of 17 sampled records reviewed, resulting in the potential for the development and spread of infection. Findings include: P-3: The patient’s start of care (SOC) was 8/30/24 with diagnoses that included Myocardial Infarction and spinal Stenosis. The Plan of Care (POC) ordered Skilled Nursing (SN), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. On 9/9/24, a scheduled survey home visit was conducted with OT #1. Prior to going into the patient’s apartment, OT #1 was noted to be fumbling through his backpack. OT #1 sat his backpack on the ground and stated, “I had my sanitizer in my bag, but I must have left it in my car.” Once inside the patient’s apartment, OT #1 placed a half-folded disposable barrier on the patient’s sofa. OT #1 then placed his backpack halfway on the barrier and the other half rested on the patient’s sofa. Upon completion of therapy services, OT #1 removed the disposable barrier and left his backpack seated on the patient’s sofa. OT #1 failed to utilize Infection Control standards during the provision of care and services. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 3:09 p.m. P-4: The patient’s start of care (SOC) was 8/20/24 with diagnoses that included Paralytic Ileus, Severe Protein Malnutrition with Vascular Access Device. The Plan of Care ordered SN services to be provided. On 9/10/24 a scheduled survey home visit was conducted with the nurse (DCS #1) for purposes of changing the dressing to the patient’s Vascular Access site. During the visit, DCS #1 set up a barrier to place the dressing supplies. While cleaning the access insertion site, DCS #1 used a sponge contained in the dressing kit and used an up/down back/forth motion to cleanse the insertion site and the tubing. This would allow for pathogens to enter the opening of the skin. DCS #1 failed to utilize proper Infection Control techniques when changing the dressing to the patient’s access site. The agency’s policy, “PICC Line Dressing Care” stated, “Using a chlorhexidine/alcohol prep swab, clean the area around the PICC line insertion site. Start at the center and move outward in a circular motion avoiding back-and-forth movement.” These findings were reviewed with and acknowledged by Adm #1 and DCS #1, who was present during the interview on 9/11/24 at 3:30 p.m.”

“Infection control education CFR(s): 484.70(c) Standard: Education. The HHA must provide infection control education to staff, patients, and caregiver(s). This Standard is not met as evidenced by: Based on record review and interview, the agency failed to provide documented evidence to support that all staff, including contracted staff, had received the required education and in-service training in Infection Control, resulting in the potential for the development and spread of infection to staff and all patients currently serviced by this agency. Findings include: On 9/10/24 at 9:15 a.m., the Administrator (Adm #1) was asked for permission to review evidence of staff training and in-services in Infection Control. Adm #1 returned shortly after this request, placed a large white binder titled “QAPI (Quality Assessment Performance Improvement)” on the desk and stated, “Whatever you’re looking for is in there.” Adm #1 then left the room. Upon review of the documents contained in the binder, along with a fellow surveyor, there was no information that pertained to staff training or education in Infection Control. Additionally, no additional documents or information had been provided by the end of the survey. All findings were reviewed with Adm #1, the Alternate Administrator and Director of Clinical Services during the exit conference.”

“Responsibilities of skilled professionals CFR(s): 484.75(b) Standard: Responsibilities of skilled professionals. Skilled professionals must assume responsibility for, but not be restricted to, the following: This Standard is not met as evidenced by: Based on record review and interview, it was determined that the Agency failed to ensure the Registered Nurse followed accepted standards of practice and failed to responsibly supervise the care in 1 (P-11) of 3 patients with LPN supervision, from a total of 17 patient records reviewed, resulting in unmet patient care needs and a poor clinical outcome. Findings include: P-11: The start of care (SOC) date for home care was 5/6/24, with diagnoses which included fluid overload-unspecified, end-stage renal disease, chronic obstructive pulmonary disease, diabetes-type 2, and bilateral BKA (below knee amputation). On 9/11/24, review of the referral for home care noted past medical history positive for fluid overload, dysphagia, status post PEG tube placement on 2/26/24, and aspiration precautions. Review of the comprehensive assessment performed by RN#1 on 5/6/24, failed to clarify the current clinical status/history concerning the above clinical findings. The Plan of Care (POC) on 5/6/24, ordered Skilled Nursing (SN) to provide a visit frequency of 2wk1 (twice a week for one week), 1wk3, Physical Therapy (PT) to evaluate and treat, and Occupational Therapy (OT) to evaluate and treat. OT performed an initial evaluation on 5/15/24 with no further needs identified. Further record review noted on 5/9/24 and 5/16/24, 2 of 2 LPN visits were missed (excused-due to scheduling conflicts). The patient was transferred to the hospital on 5/19/24 for unknown reasons per transfer summary by RN #1. RN #1 performed a ROC visit on 5/28/24, and documented hospitalization was due to encephalopathy (disorder of the brain) and cough. An ROC physician order was noted which documented SN 1wk4 and PT eval and treat, both effective 5/29/24. The next 4 scheduled SN visits (6/4/24, 6/11/24, 6/18/24, and 6/25/24 were missed, all to be performed by the LPN. The 6/4/24 missed visit (MV) was due to hospitalization but no documentation of the patient being in the hospital or for what reason was found in the medical record, and the 6/11/24 MV documented “patient/family uncooperative”. The MV on 6/18/24 documented “other” with no further explanation, and “no answer to phone call” regarding the 6/25/24 MV. No documentation of LPN supervision was found in the medical record. In addition, RN#1 had no physician communication evidenced in the medical record regarding the lack of attention concerning P-11’s medical needs. The lone visit made before P-11 was transferred again to the hospital (7/4/24) was a PT evaluation on 6/29/24 by PT #1. Review of the PT evaluation noted the following documentation: “Patient should progress well with skilled PT interventions focusing on: Safety, fall precautions, ... balance, gait with protheses for BLEs (bilateral lower extremities) and home exit management training.” No explanation was found in the medical record why PT services performed its evaluation 30 days after the effective order date (5/29/24), especially when the patient “should progress well... (per PT evaluation).” PT #1 also documented, “Patient has complicated open wound and is medically restricted to home due to high risk of infection related to open draining wounds. Patient is homebound due to recent ileostomy surgery and exhibiting pain with any movement.” On 7/4/24, P-11 was transferred again to the hospital. The transfer summary performed by RN #1 had documented, “Client was admitted into the hospital for Not feeling well. All Home Care Services to be placed on hold at this time 07/04/2024.” (sic) No further information was found in the medical record which detailed why P-11 was hospitalized or explained the serious clinical findings noted on the PT’s evaluation. No follow-up was evidenced in the medical record after the 7/4/24 transfer to ascertain the clinical outcome of P-11. The above findings were reviewed and acknowledged by the Administrator (Adm #1) and the Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 4:45 PM. Both were queried concerning the lack of visits by the LPN, the lack of effort in rescheduling the missed visits in the remaining week(s), the lack of supervision by the RN over the LPN concerning P-11’s severe medical needs at the time, and the lack of coordination of care between PT, SN, and the attending physician (MD #1). Both Adm #1 and DCS#1 noted this record did not represent the Agency’s standard of care. The Agency failed to ensure the skilled disciplines of SN, including the Director of Clinical Services, and PT had responsibly performed their duties to prioritize P-11’s health care needs throughout admission, and failed to adhere to Agency policies referenced below. Agency Policy: “Nursing Services” 9.16.1 (Revised February 2024) stated, “Nursing will be provided in accordance with the patient’s plan of care, under the supervision of a registered nurse. Professional nursing service will be provided by a registered nurse and include: Coordination of services... Informing the physician/practitioner and other staff of changes in the patient’s needs... Evaluating the effectiveness and outcomes of care... Supervising LVN/LPNs and paraprofessionals providing services...” Agency Policy: “Coordination of Patient Care” 9.13.1 (Revised February 2024) stated, “The Agency must: Coordinate care delivery to meet the patient’s needs and involve the patient... in the coordination of care activities. The Director of Clinical Services makes patient and personnel assignments and provides oversight of all patient care services.””

“Home health aide assignments and duties CFR(s): 484.80(g)(1) Standard: Home health aide assignments and duties. Home health aides are assigned to a specific patient by a registered nurse or other appropriate skilled professional, with written patient care instructions for a home health aide prepared by that registered nurse or other appropriate skilled professional (that is, physical therapist, speech-language pathologist, or occupational therapist). This Standard is not met as evidenced by: Based on record review and interview, the Agency failed to ensure the Skilled Nurse prepared clear written patient care instructions for the home health aide regarding client needs, and safety precautions prior to the provision of care in 2 (P-2, P-7) of 4 records in which Home Health Aide services were ordered, from a total of 17 sampled records reviewed, resulting in the potential for the provision of unsafe care and unmet care needs. Findings include: P-2: The patient’s start of care was 10/13/23 with diagnoses that included Hypertensive Heart Disease with Heart Failure, Diabetes Mellitus and Congestive Heart Failure. During the record review on 9/11/24 at 10:30 a.m., it was noted that the plan of care ordered home health aide services to be provided at a frequency of 1x/wk. x 3 wks. The Plan of Care (POC) noted the patient had allergies to sulfa drugs. This information was not added to the aide care plan. Additionally, the aide care plan was void of the patient’s dietary restrictions and Diabetic precautions. These findings were reviewed with and acknowledged by the Administrator and Director of Clinical Services during an interview on 9/11/24 at 2:50 p.m. P-7: The admission date for home care was 9/6/24, with diagnoses that included cystitis-unspecified with hematuria (blood in urine), heart disease with combined systolic and diastolic heart failure, and diabetes-type 2. During the record review on 9/10/24 at 9:50 AM., it was noted that the Plan of Care/485 (POC) ordered home health aide services to be provided at a frequency of 1wk4 (once a week time four weeks). Review of the aide POC revealed no bleeding precautions despite P-7 being prescribed Plavix (blood thinner). The aide POC also failed to include any diabetic precautions. Additionally, the aide POC ordered the aide to provide nail care every visit. This contradicts the orders found on the main POC/485, which stipulated “Do Not Cut Nails” due to potential diabetic complications. These findings were reviewed with and acknowledged by the Alternate Administrator (Adm #2) and Director of Clinical Services (DCS #1) during an interview on 9/12/24 at 11:20 AM.”

“Participate in care CFR(s): 484.50(c)(4)(i,ii,iii,iv,v,vi,vii,viii) Participate in, be informed about, and consent or refuse care in advance of and during treatment, where appropriate, with respect to-- (i) Completion of all assessments; (ii) The care to be furnished, based on the comprehensive assessment; (iii) Establishing and revising the plan of care; (iv) The disciplines that will furnish the care; (v) The frequency of visits; (vi) Expected outcomes of care, including patient-identified goals, and anticipated risks and benefits; (vii) Any factors that could impact treatment effectiveness; and (viii) Any changes in the care to be furnished. This Element is not met as evidenced by: Based on observation, interview and record review, the Agency failed to ensure that 4 (P-3, P-4, P-8, P-13) of 7 patients observed during home visits, from a total of 17 sampled records reviewed, were included in the overall planning of care including informing the patient/caregiver in advance of the days in which services would be provided, resulting in a lack of inclusion in planning, the potential for missed visits and unmet care needs. Findings include: P-3: The patient’s start of care (SOC) was 8/30/24 with diagnoses that included Myocardial Infarction and Spinal Stenosis. The Plan of Care (POC) ordered Skilled Nursing (SN), Physical therapy (PT) and Occupational Therapy (OT) services to be provided. On 9/9/24 a scheduled survey home visit was conducted with the Occupational Therapist (OT #1). During a review of the patient’s Admission packet, it was noted that the calendar that was to contain a scheduled of proposed visits was left blank. There was no indication of when the ordered disciplines would make their visits to the patient’s home. During the visit, OT #1 asked the patient, “Is anyone else coming out to see you today?” The patient responded, “I’m not sure when the nurse is coming back, but she did say one day this week.” The agency failed to ensure the patient was included in the planning of her care. These findings were reviewed with and acknowledged by the Administrator (Adm #1) during an interview on 9/11/24 at 3:09 p.m. who responded, “This is something I tell them (staff) all the time. All patients are required to have a completed calendar in the home.” P-4: The patient’s SOC was 8/20/24 with diagnoses that included Paralytic Ileus, Malnutrition with Vascular Access Device. The POC ordered SN services to be provided. On 9/10/24 a scheduled survey home visit was conducted with OT #1. During a review of the patient’s Admission packet, the calendar of proposed visits to be completed by the scheduled disciplines was noted to be blank. There was no indication of when SN services would be made in the patient’s home. These findings were reviewed with and acknowledged by Adm #1 during an interview on 9/11/24 at 3:30 p.m. P-8: The patient was admitted to home care on 8/19/24 with diagnoses that included chronic congestive heart failure, generalized weakness, chronic obstructive pulmonary disease, and diabetes-type 2. On 9/10/24, a joint home visit with skilled nursing (SN/RN #1) was performed. During the visit, P-8’s admission pack was reviewed, which revealed the calendar used to scheduled home visits by all disciplines assigned (Skilled Nursing and Physical Therapy) was found to be blank. There was no documented evidenced that detailed when the assigned disciplines were scheduled to make home visits. A home visit interview with the patient and patient’s family/caregivers was performed at 2:20 PM., to ascertain the method of coordinating the home visits. The patient and patient’s family responded with phone calls giving a general time for the upcoming day or week. The findings above were reviewed and acknowledged by the Alternate Administrator (Adm #2) and Director of Clinical Services (DCS #1) during an interview on 4/12/24 at 12:37 PM. Both noted that staff are to utilize the packet calendars to document the coordination of home visits. P-13: The Start of Care was dated 9/8/2024. The Plan of Care for the certification period 9/8/24 to 11/6/24 identified diagnoses of Wedge compression fracture of first lumbar vertebrae. The patient was receiving Physical Therapy (PT), Skilled Nursing (SN), and Occupational Therapy (OT) services. During a scheduled survey home visit on 9/9/24, at 2:00 p.m., it was noted there was no visit calendar in the patient’s home to ensure the patient would know dates and times of scheduled visits. When the patient was queried about the visit schedules for PT, OT and SN services, the patient stated, “the Physical Therapist comes on the same days each week, Monday and Wednesdays, and the Nurse calls me to let me know she is coming.” The patient further stated, “I am usually always home.” The agency failed to provide a calendar that included time and dates of visits for PT, OT, and SN services to include the patient’s preferences in the planning of staff visits. These findings were reviewed and acknowledged during an interview on 9/12/24 at 1:30 PM by the Alternate Administrator (Adm#2) and the Director of Clinical Services (DCS #1).”

“Written notice for non-covered care CFR(s): 484.50(c)(8) Receive proper written notice, in advance of a specific service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care. The HHA must also comply with the requirements of 42 CFR 405.1200 through 405.1204. This Element is not met as evidenced by: Based on record review and interview, the agency failed to ensure the patient received proper written notice/Notice of Medicare Provider Non-Coverage, in advance of terminating on-going care for 2 (P-2, P-12) of 5 patients who were discharged from the agency’s services, from a total of 17 sampled records reviewed, resulting in the patient being denied the right to appeal the decision to end covered services. Findings include: The patient’s start of care was 10/13/23 with diagnoses that included Hypertensive Heart Disease with Heart Failure and diabetes Mellitus. During the clinical record review on 9/11/24 at 10:30 a.m., it was noted that the Plan of Care ordered Skilled Nursing, Physical Therapy and Occupational Therapy services to be provided. The patient was discharged from the agency on 11/2/23. Upon further review, the document titled “Notice of Medicare Non-Coverage” was void of any information detailing when services would end and when or if the document had been provided to the patient. These findings were reviewed with and acknowledged by the Administrator and Director of Clinical Services during an interview on 9/11/24 at 2:50 p.m. P-12: The start of care (SOC) date was 3/26/24 with diagnoses which included hypertensive heart disease with combined systolic and diastolic heart failure, diabetes-type 2, and chronic obstructive pulmonary disease. Record review on 9/11/24, noted the plan of care ordered Skilled Nursing, Physical Therapy, and Occupational Therapy services to be provided. Additional review noted P-12 was discharged from the Agency on 5/24/24 and found that CMS Form-10123-NOMNC (Notice of Medicare Non-Coverage) was filled out on the day of discharge. Subsequently, P-12 had no advance notification (2 days) as required pertaining the discontinuation of all home care services. P-12 had insufficient time allowances to potentially disagree with the discharge at that time. This finding was reviewed and acknowledged by the Alternate Administrator (Adm #1) and the Director of Clinical Services (DCS #1) on 9/12/24 at 12:50 PM. P-12: The start of care (SOC) date was 3/26/24 with diagnoses which included hypertensive heart disease with combined systolic and diastolic heart failure, diabetes-type 2, and chronic obstructive pulmonary disease. Record review on 9/11/24, noted the plan of care ordered Skilled Nursing, Physical Therapy, and Occupational Therapy services to be provided. Additional review noted P-12 was discharged from the Agency on 5/24/24 and found that CMS Form-10123-NOMNC (Notice of Medicare Non-Coverage) was filled out on the day of discharge. Subsequently, P-12 had no advance notification (2 days) as required pertaining the discontinuation of all home care services. P-12 had insufficient time allowances to potentially disagree with the discharge at that time. This finding was reviewed and acknowledged by the Alternate Administrator (Adm #1) and the Director of Clinical Services (DCS #1) on 9/12/24 at 12:50 PM. The patient’s start of care was 10/13/23 with diagnoses that included Hypertensive Heart Disease with Heart Failure and diabetes Mellitus. During the clinical record review on 9/11/24 at 10:30 a.m., it was noted that the Plan of Care ordered Skilled Nursing, Physical Therapy and Occupational Therapy services to be provided. The patient was discharged from the agency on 11/2/23. Upon further review, the document titled “Notice of Medicare Non-Coverage” was void of any information detailing when services would end and when or if the document had been provided to the patient. These findings were reviewed with and acknowledged by the Administrator and Director of Clinical Services during an interview on 9/11/24 at 2:50 p.m.”

“Patient’s needs CFR(s): 484.55(c)(4) The patient’s medical, nursing, rehabilitative, social, and discharge planning needs; This Element is not met as evidenced by: P-5: The patient’s start of care was 8/27/24 with diagnoses that included Acute and Chronic Respiratory Failure, CHF AND COPD. During the clinical record review on 9/11/24 at 12:55 p.m., the section of the Initial Comprehensive Assessment titled “Supportive Assistance”, under Living Arrangement, documented, “Patient lives with other person(s) in home around the clock...” There was no mention of a designated caregiver or anyone who would be willing to provide assistance with Activities of Daily Living (ADLs). The section titled “Functional Status” documented, “Poor balance, high risk for falls, muscle weakness...” Section M1800 documented, “Grooming utensils must be placed within reach..., Someone must help put on upper/lower body clothing, someone must assist with toileting hygiene...” Upon further review, there was no documented evidence that the patient was offered the opportunity to receive home health aide services to assist with grooming. These findings were discussed with and acknowledged by the Administrator and Director of Clinical Services during an interview on 9/11/24 at 3:45 p.m.”

“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 observation, record review and interview, the agency failed to ensure the comprehensive assessment included a review of all the patient’s prescribed and over the counter medications for 3 (P-3, P-4, P-8) patients to determine any adverse effects, from a total of 17 sampled records reviewed, resulting in the potential for harmful medication effects for all patients currently serviced by this Agency. Findings include: P-3: The patient’s start of care (SOC) was 8/30/24 with diagnoses that included Myocardial Infarction and Spinal Stenosis. During the clinical record review on 9/9/24 at 3:35 p.m., it was noted that the Plan of Care (POC) and Medication Profile listed 8 of the patient’s prescribed medications (Norco, Spiriva inhaler, Advair inhaler, Aspirin, Hydralazine, Nifedipine, Atorvastatin and Gabapentin). On 9/9/24 during a scheduled survey home visit with the Occupational Therapist, additional medications (Lidocaine cream, Albuterol inhaler and Tizanidine) were observed in the patient’s home that had not been included on the Medication Profile or POC. Additionally, the patient’s hospital discharge paperwork dated 8/29/24 also ordered Fluticasone inhaler to be used 2 times/day. This medication was not added to the Medication profile or POC. Based on the above information, it was determined the agency failed to include all the patient’s prescribed medications during a comprehensive drug review. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 3:09 p.m. P-4: The patient’s SOC was 8/20/24 with diagnoses that included Paralytic Ileus, Protein Malnutrition with Vascular Access. During the record review on 9/10/24 at 11:25 a.m., it was noted that the POC and Medication Profile listed 4 of the patient’s prescribed medications (Apixaban, Gabapentin, Pancrelipase and Pantoprazole). On 9/10/24 during a scheduled survey home visit with the Registered Nurse (DCS #1). During the visit, DCS #1 inquired of the patient pain regimen and stated, “I know you still have the Tylenol.” Tylenol had not been included on the patient’s Medication Profile or POC. There was no evidence that Tylenol was included in the initial drug review to ascertain any untoward drug interactions. These findings were reviewed with and acknowledged by Adm #1 and DCS #1 during an interview on 9/11/24 at 3:30 p.m. P-8: The admit date for home care was8/19/2024, with diagnoses which included congestive heart failure, generalized weakness, chronic obstructive pulmonary disease, and diabetes-type 2. On 9/10/24, a joint home visit with skilled nursing (SN/RN #1) was performed. During the home visit, P-8’s medication bottles were compared to the list of current medications found on the Plan of Care (POC). Several discrepancies were observed: The medication bottle with Eliquis (blood thinner to help prevent stroke) had a dosage of 5 mg. to be taken daily. The POC listed the dose as 2.5 mg. daily. The POC also listed Plavix (blood thinner) and Mucinex (treat respiratory congestion), however both were not observed in the home. Both of the patient’s caregivers (daughter and granddaughter) stated the Plavix and Mucinex were never in the home. In addition, the home visit revealed P-8’s blood sugars recently ran in the “300 to 400” range. RN #1 then stated those readings were before he started his new insulin (medication used to lower blood sugar). After the visit, RN #1 was queried if she had ever checked P-8’s blood sugars to review how he reacted to the newly prescribed insulin. RN #1 replied, “No” and further acknowledged the observed medication discrepancies discovered during the home visit. The above findings were reviewed with and acknowledged by the Alternate Administrator (Adm #2) and the Director of Clinical Services (DCS #1) during an interview on 9/12/24 at 11:40 AM.”

“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 record review, policy review, and interview, the agency failed to ensure that the goals on the Plan of Care were individualized to the patient’s specific needs and measurable to determine the patient’s progress towards attaining the goals in 11 of 17 (P-2, P-4, P-5, P-8, P-11, P-12, P-13, P-14, P-15, P-16, P-17) records reviewed resulting in the inability to determine the patient’s progress towards achieving the goals. Findings included: **Agency Policy: “Plan of Care-CMS #485 and Physician/Practitioners Orders”, dated February 2024. The policy states, “The individualized plan of care must include the following: Patient-specific interventions and education, measurable outcomes and goals...” P-8: The patient was admitted to home care on 8/19/24 with diagnoses that included chronic congestive heart failure (CHF), generalized weakness, chronic obstructive pulmonary disease, and diabetes-type 2. During record review on 9/10/24, it was noted the plan of care (POC) ordered skilled nursing (SN), physical therapy (PT), and Occupational Therapy (OT) to provide services to meet the patient’s clinical needs. Further review of the POC noted there were no safety parameters (e.g. weight or limb extremity circumference measurements) in which to evaluate potential exacerbation (worsening) of P-8’s CHF. Additionally, 14 of 14 listed SN and OT goals were not written in measurable terms. For example, SN documented, “Patient/Caregiver will be able to verbalize signs and symptoms of cardiac complications, when to call physician, nurse or 911 by 9/14/2024” and OT documented, “Patient/Caregiver will be able to identify fall risk factors by 09/14/2024.” These findings were reviewed with and acknowledged by the Alternate Administrator (Adm #2) and Director of Clinical Services (DCS #1) during an interview on 9/12/24 at 12:37 PM. Both noted goals on the POC need to be written in measurable terms. P-11: The start of care (SOC) date was 5/6/24, with diagnoses which included fluid overload-unspecified, end-stage renal disease, chronic obstructive pulmonary disease, and diabetes-type 2. Record review on 9/11/24, noted the POC ordered SN, PT, and OT to provide clinical care services. Further review of the POC noted there were no measurable safety parameters (e.g. weight or limb extremity circumference measurements) in which to evaluate potential exacerbation (worsening) of P-11’s primary diagnoses of fluid overload. Additionally, 10 of 10 listed SN goals were not written in measurable terms. For example, SN documented, “Patient/Caregiver will be able to verbalize signs and symptoms of cardiac complications, when to call physician, nurse or 911 by 6/1/2024” and “Patient and caregiver will be able to identify fall risk factors by 06/1/2024.” The above findings were reviewed and acknowledged by the Administrator (Adm #1) and the Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 4:45 PM. P-12: The SOC date for home care was 3/26/24, with diagnoses which included hypertensive heart disease with combined systolic and diastolic heart failure, diabetes-type 2, and chronic obstructive pulmonary disease. On 9/12/24, record review noted the POC ordered SN and PT to provide clinical care services. Further review of the POC noted there were no measurable safety parameters (e.g. weight or limb extremity circumference measurements) in which to evaluate potential exacerbation (worsening) of P-12’s primary diagnoses of CHF. Additionally, 9 of 9 listed SN goals were not written in measurable terms. For example, SN documented, “Patient’s activity level will improve due to effective pain control by 4/20/24” and “Patient/Caregiver will be able to verbalize signs and symptoms of cardiac complications, when to call physician, nurse or 911 by 4/20/2024.” During an interview on 9/12/24 at 12:50 PM the above findings were reviewed and acknowledged by the Alternate Administrator (Adm#2) and the Director of Clinical Services (DCS #1). P-2: The patient’s start of care (SOC) was 10/13/23 with diagnoses that included Hypertensive Heart and Chronic Kidney Disease with Heart Failure, Congestive Heart Failure (CHF) and diabetes Mellitus (DM). During the record review on 9/11/24 at 10:30 a.m., it was noted that the Plan of Care (POC) ordered Skilled Nursing (SN), Home Health Aide (HHa), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. Upon further review, the POC was void of any CHF management with reportable parameters in which to inform the Physician and the set pain parameters were to notify the Physician of pain greater than 8. However, the patient’s pain on admission was 3/10. The parameters did not address the individualized needs of the patient. Additionally, there were no blood sugar frequencies or DM management and no associated goals that addressed the patient’s diagnoses. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 2:50 p.m. P-4: The patient’s SOC was 8/20/24 with diagnoses that included Paralytic Ileus and Severe Protein Malnutrition with Vascular Access Device (For purposes of administering TPN/Total Parental Nutrition). The POC ordered SN for management of, and dressing changes to the patient’s PICC (Peripherally Inserted Central Catheter) line. Upon review of the POC on 9/10/24 at 11:25 a.m., it was noted that there were no interventions related to care of the PICC site or dressing change instructions. On 9/10/24, a scheduled survey home visit was conducted with the SN (DCS #1). During the visit, DCS #1 and the patient discussed the patient’s loss of appetite and weight fluctuation. The POC was void of any interventions to assess/monitor the patient’s weight in light of her diagnosis of Severe Protein Malnutrition. Further, the patient denied having any pain since admission, however, the POC instructed staff to report pain levels greater than 8. This pain goal did not address the individualized needs of the patient. Additionally, there were no associated measurable goals that addressed the patient’s diagnoses. These findings were reviewed with and confirmed by Adm #1 and DCS #1 during an interview on 9/11/24 at 3:30 p.m. P-5: The patient’s SOC was 8/27/24 with diagnoses that included Acute/Chronic Respiratory Failure, Chronic Congestive Heart Failure and Chronic Obstructive Pulmonary Disease. During the record review on 9/11/24 at 12:55 p.m., it was noted that the SN interventions on the POC were vague such as, “SN to instruct patient on disease process..., self-management program for COPD..., self-management program for acute and chronic respiratory failure and hypoxia..., instruct regarding heart failure status and self-management program...” The goals were not measurable such as, “Patient/caregiver will demonstrate competence...” There were no specific SN interventions to address the identified diagnoses. The POC instructed to report pain levels greater than 8, however, the patient denied having any pain on admission. These parameters did not address the individualized needs of the patient. The above findings were reviewed with and acknowledged by Adm #1 and DCS #1 during an interview on 9/11/24 at 3:45 p.m. P-13: The Start of Care (SOC) was dated 9/8/2024. The Plan of Care (POC) for the certification period (9/8/24 to 11/6/2024 identified diagnoses of Wedge compression fracture of first lumbar vertebrae, encounter for change or removal of surgical wound dressing, Fracture of shaft of right tibia, fracture of greater tuberosity of right humorous, weakness, abnormalities of gait and mobility, nicotine dependence and obesity. The patient was receiving Physical Therapy (PT), Skilled Nursing (SN), and Occupational Therapy (OT) services. Upon review of the Plan of Care (POC), it was noted the goals on the POC were not objectively measurable or specific to the patient’s needs. Examples included: “Occupational Therapy (OT) evaluation will be performed and a plan of care to increase functional independence with ADLs (Activities of Daily Living) and IADLS (Instrumental Activities of Daily Living) will be established and countersigned by the physician. This goal is specific to the duties of the OT rather than specific to the needs of the patient. Additional unmeasurable goals included: “patient will demonstrate return to stable musculoskeletal status related to multiple fractures with improvement/maintenance of maximal level of functioning by 10/05/2024; Patient/caregiver will demonstrate understanding of individual emergency preparedness plan. These goals are not measurable to determine the patient’s progress towards achieving the goals. P-14: The Start of Care (SOC) was dated 5/9/2024. The Plan of Care (POC) for the certification period 9/6/24 to 11/4/24 identified diagnoses of Change or removal of surgical dressing, open wound of front wall of thorax without penetration through the cavity, Fracture of head of left femur, end state renal disease, Chronic Kidney Disease/ESRD Stage 5. The patient was receiving Skilled Nursing and Physical Therapy Services. A home visit was conducted on 9/10/24. Upon review of the plan of care, it was noted the goals on the plan of care were not objectively measurable. Examples included: “Patient will attain optimal effectiveness of pain management regimen; Patient will demonstrate ability to effectively manage medication regimen by 7/6/2024. Patient will achieve optimal wound healing without further signs/symptoms of infection or complications by 7/6/2024. These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. P-15: The Start of Care (SOC) was dated 8/26/24. The Plan of Care (POC) for the certification period 8/26/24 to 10/24/24 identified diagnoses of Change and/or removal of non-surgical wound dressing, Chronic Kidney Disease (CKD) Non-pressure chronic ulcer of lower leg limited to breakdown of skin, End-stage renal disease, Acute and chronic respiratory failure, Chronic Kidney Disease (CKD), Renal Dialysis, and Heart Failure. The patient was receiving Skilled Nursing (SN), Physical Therapy (PT), and Occupational Therapy Services. Upon review of the Plan of Care (POC), it was noted the goals on the POC were not objectively measurable or specific to the patient’s needs. Examples included: “Patient will achieve optimal effectiveness of pain management effectiveness by 9/21/2024. Patient will be able to identify fall risk factors; Occupational Therapy evaluation will be performed and a plan of care to increase functional independence with ADLs (Activities of Daily Living) will be established and countersigned by the physician. These goals are not objectively measurable to determine the patient’s progress toward obtaining the goals. P-16: The Start of Care (SOC) was dated 11/7/2023. The Plan of Care (POC) for the certification period 11/7/2024 to 1/5/2024 identified diagnoses of Diabetes Type II (DM2), Congestive Heart Failure (CHF), Hypertensive Chronic Kidney Disease (CKD), Chronic Obstructive Pulmonary Disease (COPD), and Hyperlipidemia. The Patient was receiving Skilled Nursing (SN), Physical Therapy (PT), Occupational Therapy (OT), and Home Health aide (HHa) services. Upon review of the POC, it was noted, the goals on the POC were not objectively measurable. Examples included: “Patient and caregiver will be able to identify fall risk factors by 12/2/2023; Patient will wear appropriate footwear to prevent falls by 12/2/2023; Patient will demonstrate compliance with home exercise program by 12/2/2023; and Physical Therapist Evaluation will be performed and a plan of care to increase functional independence will be established and countersigned by physician (this is an order for the physical therapist, not a measurable goal for the patient).These goals are not objectively measurable to determine the patient’s progress towards obtaining the goals. P-17: The Start of Care (SOC) was dated 6/20/2-24. The Plan of Care (POC) for the certification period 6/20/24 to 8/18/2024 identified diagnoses of Surgical Aftercare for Surgery on the Digestive System, Ileostomy Status, Crohn’s Disease of Large Intestine, Chronic Kidney Disease, Diabetes type 2, Long-term use of Insulin, and Hyperlipidemia. The patient was receiving Skilled Nursing and Physical Therapy services. Upon review of the goals on the POC, it was noted the goals were not objectively measurable to assist in determining the patient’s progress towards obtaining the goals. Examples included: “Patient/Caregiver will be able to verbalize signs and symptoms of wound infection to report and demonstrate proper infection precautions by 7/13/24; Patient caregiver will be able to identify fall risk factors; Patient will attain optimal effectiveness of pain management regimen by 7/13/2024.” These goals are not objectively measurable to determine the patient’s progress towards achieving the goals. These findings were reviewed and acknowledged during an interview on 9/12/24 at 1:30 PM by the Alternate Administrator (Adm#2) and the Director of Clinical Services (DCS #1).”

“Patient medication schedule/instructions CFR(s): 484.60(e)(2) Patient medication schedule/instructions, including: medication name, dosage and frequency and which medications will be administered by HHA personnel and personnel acting on behalf of the HHA. This Element is not met as evidenced by: Based on observation, interview and record review, it was determined that the agency failed to provide 1 (P-3) of 1 patients observed during home visits, with a Medication Profile that included the names, dosages and frequencies of the patient’s prescribed medications, in plain language, from a total of 17 sampled records reviewed, resulting in lack of direction for medication administration and the potential for improper use of medications. Findings include: P-3: The patient’s start of care (SOC) was 8/30/24 with diagnoses that included Myocardial Infarction and Spinal Stenosis. During the clinical record review on 9/9/24 at 3:35 p.m., it was noted that the Plan of Care (POC) and Medication Profile listed 8 of the patient’s prescribed medications (Norco, Spiriva inhaler, Advair inhaler, Aspirin, Hydralazine, Nifedipine, Atorvastatin and Gabapentin). On 9/9/24 during a scheduled survey home visit with the Occupational Therapist, additional medications (Lidocaine cream, Albuterol inhaler and Tizanidine) were observed in the patient’s home that had not been included on the POC. Additionally, the patient’s hospital discharge paperwork dated 8/29/24 also ordered Fluticasone inhaler to be used 2 times/day. This medication was not added to the POC. Additionally, during the visit, the patient’s admission documents were reviewed with contained an illegible carbon copy of a Medication Profile. The writing could not be deciphered and did not include all the patient’s ordered medications. The agency failed to ensure the patient was provided with a clear and accurate Medication Profile with the required instructions and information. These findings were reviewed with and acknowledged by the Administrator (Adm #1) and Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 3:09 p.m.”

“Improvements are sustained CFR(s): 484.65(c)(3) The HHA must take actions aimed at performance improvement, and, after implementing those actions, the HHA must measure its success and track performance to ensure that improvements are sustained. This Element is not met as evidenced by: Based on record review and interview, the Agency failed to measure the success of its performance improvement projects to ensure the improvements were sustained, resulting in the potential for the rendering of substandard care and poor patient outcomes. Findings include: On 9/12/24 at 11:05 a.m., the Agency’s QAPI (Quality Assessment Performance Improvement) documents were reviewed. The provided binder contained data from patient complaints, infection control reports and information from chart audits. There was no documentation of any Performance Improvement Projects based on the above collected data. When asked to review the agency’s Performance Improvement Projects for the current and previous years, the Alternate Administrator/CEO (Adm #2) reviewed the documents in the binder and reported, “I agree with you. I don’t see anything in the binder, but I can look in the hard drive.” On 9/12/24 at 3:00 p.m., Adm #2 stated, “I uploaded the Performance Improvement Project for your review. We had one on wound care. Adm #2 provided a document which stated “Wound Care” with a calendar date of 1/1/2024 through 12/31/2024. When asked to review the previous projects, Adm #2 was unable to provide them as requested. Based on the above findings, it was determined that the agency’s lack of consistent Performance Improvement activities was not sufficient to determine if any improvements were sustained. These findings were acknowledged at the time of the 3:00 p.m. interview.”

“Development and evaluation of plan of care CFR(s): 484.75(b)(2) Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s); This Element is not met as evidenced by: Based on record review, and interview, the Agency failed to ensure skilled nursing (SN) had developed a plan of care (POC) that incorporated safety parameters to effectively monitor for congestive heart failure (CHF), and failed to update the POC during a resumption of care (ROC) due to CHF exacerbation in 1 (P-12) of 2 records reviewed with a ROC due to CHF, out of a total sample of 17 records reviewed, resulting in the potential for unidentified care needs and poor clinical outcomes. Findings included: P-12: The start of care (SOC) date was 3/26/24 with diagnoses which included hypertensive heart disease with combined systolic and diastolic heart failure, diabetes-type 2, and chronic obstructive pulmonary disease. On 9/11/24, record review of P-12’s POC (dated 3/26/24) noted an ordered SN visit frequency of 1wk4 (once weekly time 4 weeks). Further POC review revealed no specific measures, interventions, or patient education to effectively monitor for CHF exacerbation (worsening). No baseline weight parameters or lower extremity circumference measurements were evidenced in the medical record. On 3/31/24, P-12 was “transferred to hospital due to respiratory problems.” The ROC visit performed by RN/DCS #1 documented the patient was sent home with 3.5 liters per minute of oxygen to help with shortness of breath P-12 was experiencing at the time. The SN visit frequency after the ROC visit was 2 wk1, 1wk3 and were provided timely by the LPN on 4/10/24, 4/19/24, and 4/25/24. However, all visits by the LPN failed to collect any objective data concerning fluid overload. On 4/28/24, the RN (DCS #1) documented “Client was admitted into the hospital for unknown reason.” Further record review of the hospital discharge paperwork pertaining to P-12’s 4/28/24 admission documented the following: “(P-12) is a 74-year-old male with history of chronic combined systolic and diastolic heart failure… who was admitted from assisted living facility for CHF exacerbation…Will monitor the patient’s weight closely.” The POC following the ROC visit was reviewed for significant updates to effectively monitor CHF exacerbation signs and symptoms to mitigate another poor clinical outcome. The review found no updates or changes concerning CHF management from the original POC on 3/26/24. Further, 10 of 10 goal dates listed on the updated POC (effective 5/8/24) following the ROC visit matched the same goals and dates (4/20/24) as the 3/26/24 POC. These findings were reviewed and acknowledged by the Alternate Administrator (Adm #1) and the Director of Clinical Services (DCS #1) on 9/12/24 at 12:50 PM.”

“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 record review, and interview, the Agency failed to ensure skilled nursing (SN) had provided services as ordered in the plan of care (POC) 1 (P-11) of 3 records reviewed with a hospital transfer, out of a total sample of 17 records reviewed, resulting in unmet patient needs and a poor clinical outcome. Findings included: P-11: The start of care (SOC) date for home care was 5/6/24, with diagnoses which included fluid overload-unspecified, end-stage renal disease, chronic obstructive pulmonary disease, diabetes-type 2, and bilateral BKA (below knee amputation). On 9/11/24, record review of the plan of care (POC) dated 5/6/24, ordered Skilled Nursing (SN) to provide a visit frequency of 2wk1 (twice a week for one week), 1wk3, Physical Therapy (PT) to evaluate and treat, and Occupational Therapy (OT) to evaluate and treat. OT performed an initial evaluation on 5/15/24 with no further needs identified. Further record review noted on 5/9/24 and 5/16/24, 2 of 2 LPN visits were missed (excused-due to scheduling conflicts). The patient was transferred to the hospital on 5/19/24 for unknown reasons per transfer summary by RN #1. RN #1 performed a ROC visit on 5/28/24, and documented hospitalization was due to encephalopathy (disorder of the brain) and cough. An ROC physician order on 5/28/24 was noted which documented SN 1wk4 and PT eval and treat, both effective 5/29/24. The next 4 scheduled SN visits (6/4/24, 6/11/24, 6/18/24, and 6/25/24 were missed, all to be performed by the LPN. The 6/4/24 missed visit (MV) was due to hospitalization but no documentation of the patient being in the hospital or for what reason was found in the medical record, and the 6/11/24 MV documented “patient/family uncooperative”. The MV on 6/18/24 documented “other” with no further explanation, and “no answer to phone call” regarding the 6/25/24 MV. Additional record review found no effort or further attempts were made to make up any of the missed visits and no physician communication was noted concerning the ordered visit frequency not being met before or after the 5/19/24 hospitalization. The lone visit made before P-11 was transferred again to the hospital (7/4/24) was a PT evaluation on 6/29/24 by PT #1. Review of the PT evaluation noted the following documentation: “Patient should progress well with skilled PT interventions focusing on: Safety, fall precautions, ... balance, gait with protheses for BLEs (bilateral lower extremities) and home exit management training.” No explanation was found in the medical record why PT services performed its evaluation 30 days after the effective order date (5/29/24), especially when the patient “should progress well... (per PT evaluation).” PT #1 also documented, “Patient has complicated open wound and is medically restricted to home due to high risk of infection related to open draining wounds. Patient is homebound due to recent ileostomy surgery and exhibiting pain with any movement.” The above findings were reviewed and acknowledged by the Administrator (Adm #1) and the Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 4:45 PM. Both were queried concerning the lack of visits by the LPN, the lack of effort in rescheduling the missed visits to comply with the ordered visit frequency, and the numerous missed opportunities by PT to evaluate P-11 timely as ordered on 5/29/24. Both Adm #1 and DCS#1 noted this record did not represent the Agency’s standard of care. The Agency failed to ensure SN and PT provided care as ordered to meet the clinical needs of the patient and failed to adhere to Agency policy referenced below. Agency Policy: “Nursing Services” 9.16.1 (Revised February 2024) stated, “Nursing will be provided in accordance with the patient’s plan of care, under the supervision of a registered nurse.””

“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 record review and interview, it was determined the Agency failed to ensure skilled nursing (SN) communicated with the physician concerning staff not providing services as ordered in the plan of care and failed to notify the physician of a significant change in condition in 1 (P-11) of 3 records reviewed with a hospital transfer, resulting in unmet patient care needs and a poor clinical outcome. Findings include: P-11: The start of care (SOC) date for home care was 5/6/24, with diagnoses which included fluid overload-unspecified, end-stage renal disease, chronic obstructive pulmonary disease, diabetes-type 2, and bilateral BKA (below knee amputation). On 9/11/24, record review of the plan of care (POC) dated 5/6/24, ordered Skilled Nursing (SN) to provide a visit frequency of 2wk1 (twice a week for one week), 1wk3, Physical Therapy (PT) to evaluate and treat, and Occupational Therapy (OT) to evaluate and treat. OT performed an initial evaluation on 5/15/24 with no further needs identified. Further record review noted on 5/9/24 and 5/16/24, 2 of 2 LPN visits were missed (excused-due to scheduling conflicts). The patient was transferred to the hospital on 5/19/24 for unknown reasons per transfer summary by RN #1. RN #1 performed a ROC visit on 5/28/24, and documented hospitalization was due to encephalopathy (disorder of the brain) and cough. An ROC physician order on 5/28/24 was noted which documented SN 1wk4 and PT eval and treat, both effective 5/29/24. The next 4 scheduled SN visits (6/4/24, 6/11/24, 6/18/24, and 6/25/24 were missed, all to be performed by the LPN. The 6/4/24 missed visit (MV) was due to hospitalization but no documentation of the patient being in the hospital or for what reason was found in the medical record, and the 6/11/24 MV documented “patient/family uncooperative”. The MV on 6/18/24 documented “other” with no further explanation, and “no answer to phone call” regarding the 6/25/24 MV. Additional record review found no effort or further attempts were made to make up any of the missed visits and no physician communication was noted concerning the fact that 6 of 6 scheduled SN visits were missed before being transferred to the hospital again on 7/4/24. Further, significant changes in P-11’s condition (new open wounds) were noted on PT’s evaluation (6/29/24) which documented, “Patient has complicated open wound and is medically restricted to home due to high risk of infection related to open draining wounds. Patient is homebound due to recent ileostomy surgery and exhibiting pain with any movement.” All represented new clinical findings as SN failed to make any visits since the ROC visit on 5/28/24. No evidence was found that PT #1 had communicated the new findings with the physician or SN to help coordinate the new care needs revealed on 6/29/24. The above findings were reviewed and acknowledged by the Administrator (Adm #1) and the Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 4:45 PM. Both were queried about the lack of physician involvement concerning the severe absence of SN interventions throughout home care admission, as well the lack of physician communication pertaining to the new open draining wounds, new ileostomy needs, and new pain issues with any movement. Both Adm #1 and DCS#1 noted this record did not represent the Agency’s standard of care. The Agency failed to ensure clinical staff effectively communicated with the physician to meet the needs of the patient and failed to adhere to Agency policy referenced below. Agency Policy: “Coordination of Patient Care” 9.13.1 (Revised February 2024) stated, “To ensure that quality services are being provided to patients; ...The Agency must: Assure communication with all physicians/practitioners involved in the plan of care... Coordinate care delivery to meet the patient’s needs...””

“Discharge and transfer summaries CFR(s): 484.110(a)(6)(i-iii) (i) A completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the HHA (if any) within 5 business days of the patient’s discharge; or (ii) A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or (iii) A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer. This Element is not met as evidenced by: Based on record review and interview, the Agency failed to ensure a discharge summary was complete, provided the patient’s health status at the time of discharge, documented progress toward goals and forwarded to the Physician within 5 days of the date of discharge in 2 (P-2, P-12,) of 5 closed records; and failed to ensure the transfer summary was complete and sent to the physician/receiving facility within 2 business days of the patient’s transfer for 2 (P-11, P-14) of 3 records in which the patient was transferred to an inpatient facility, from a total of 17 sampled records reviewed, resulting in the physician not having a clear picture of the patient’s status at the time of discharge, the physician/receiving facility not having sufficient knowledge of the patient’s health status at the time of transfer, and the potential for unidentified continuing health care concerns and unmet care needs. Findings include: P-2: The patient’s start of care was 10/13/23 with diagnoses that included Hypertensive Heart and Chronic Kidney Disease with Heart Failure, Congestive Heart Failure and diabetes Mellitus. During the record review on 9/11/24 at 10:30 a.m., it was noted that the Plan of Care ordered Skilled Nursing (SN), Home Health Aide (HHa), Physical Therapy (PT) and Occupational Therapy (OT) services to be provided. The patient was discharged from PT services on 10/30/23. The PT Discharge Summary was void of a summary that detailed the course of care provided with responses and the patient’s health status at the time of discharge. Further, there was no documented evidence that the PT Discharge Summary was sent to the Physician within 5 days of the date of discharge. The patient was discharged from SN services on 11/2/23. The SN Discharge Summary was void of a summary of care that detailed the course of care provided and the overall health status at the time of discharge. Additionally, there was no documented evidence that the SN Discharge Summary was sent to the Physician within 5 days of the date of discharge. These findings were discussed with and acknowledged by the Administrator and Director of Clinical Services during an interview on 9/11/24 at 2:50 p.m. P-11: The start of care (SOC) date was 5/6/24, with diagnoses which included fluid overload-unspecified, end-stage renal disease, chronic obstructive pulmonary disease, and diabetes-type 2. Record review on 9/11/24, noted the plan of care (3/26/24) ordered the following disciplines to evaluate and treat P-12: Skilled Nursing, Physical Therapy, and Occupational Therapy. Additional review found P-11 was transferred to the hospital on 5/19/24 with no cause identified. Further review of the transfer summary noted no evidence of an attached, up to date medication list and no evidence of any clinical care/services that were provided up to transfer for any of the ordered disciplines. The “Summary of Care Provided by HHA” was blank, the “Medication Review” was left blank, and the “Transfer Facility Information” section was also left blank. Adm #1 upon request, looked up when the transfer summary was sent to the hospital and the documentation showed a fax confirmation dated 6/13/24 (21 days overdue). The above findings were reviewed and acknowledged by the Administrator (Adm #1) and the Director of Clinical Services (DCS #1) during an interview on 9/11/24 at 4:45 PM. P-12: The SOC date for home care was 3/26/24, with diagnoses which included hypertensive heart disease with combined systolic and diastolic heart failure, diabetes-type 2, and chronic obstructive pulmonary disease. The Plan of Care (POC) on 3/26/24, ordered the following disciplines to evaluate and treat P-12: Skilled Nursing, Physical Therapy, and Occupational Therapy. On 9/12/24, review of the “Home Health Discharge Summary” (dated 5/24/24) noted that there was no status of problems identified by each discipline, the patients over all status at admission and throughout care/discharge, a summary of the specific services that were provided, documentation of what specific goals were met, or a summary of the patient’s response to care provided. During an interview on 9/12/24 at 12:50 PM the above findings were reviewed and acknowledged by the Alternate Administrator (Adm#2) and the Director of Clinical Services (DCS #1). P-14: The Start of Care (SOC) was dated 5/9/2024. The Plan of Care (POC) for the certification period 5/9/24 to 7/8/24 identified diagnoses of Change or removal of drains, Open wound of front wall of thorax without penetration through the cavity, Fracture of head of left femur, End stage renal disease, Hypertensive Heart and Chronic Kidney Disease with Heart Failure and Stage 5 Chronic Kidney Disease. The patient was receiving Skilled Nursing and Physical Therapy Services. This patient was transferred to an inpatient hospital on 6/23/24 due to falling and fracturing her hip and was not discharged from the agency. Further review of the Transfer Summary documented that there was “No Current reconciled medication list provided to the subsequent provider” {sic}. There was no evidence of any clinical care/service information that had been provided by the Hospice that had been forwarded to the receiving hospital. The agency failed to provide the patient’s health information to ensure continuity of care between the home care services that had been provided and needed information required to inform the receiving facility of the health care needs of the patient.”