Devoted Healthcare, Inc.

“Development of EP Policies and Procedures CFR(s): 484.102(b) §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: Based on a review of the Agency’s Emergency Operations Plan and staff interviews, it was determined the Agency failed to establish policies and procedures based on the risk assessment. This has the potential to affect all Pts. that receive service from the Agency. Findings include: 1. The Emergency Operations Plan last updated on 12/17/24 was reviewed on 4/8/25. The Plan included the “Hazard Vulnerability Analysis” (risk assessment) form that contained different types of potential emergencies associated with utility failures, hazardous materials, security, terrorism, community mass casualty and other emergencies. As of 4/8/25, the Emergency Operations Plan lacked policies and procedures based on potential emergencies contained in the “Hazard Vulnerability Analysis”. 2. During staff interviews with the Administrator and QAPI Nurse on 4/9/25 at 9:30 AM, both confirmed the Emergency Operations Plan lacked policies and procedures based on the risk assessment.”

“EP Training Program CFR(s): 484.102(d)(1) §403.748(d)(1), §416.54(d)(1), §418.113(d)(1), §441.184(d)(1), §460.84(d)(1), §482.15(d)(1), §483.73(d)(1), §483.475(d)(1), §484.102(d)(1), §485.68(d)(1), §485.542(d)(1), §485.625(d)(1), §485.727(d)(1), §485.920(d)(1), §486.360(d)(1), §491.12(d)(1). *[For RNCHIs at §403.748, ASCs at §416.54, Hospitals at §482.15, ICF/IIDs at §483.475, HHAs at §484.102, REHs at §485.542, “Organizations” under §485.727, OPOs at §486.360, RHC/FQHCs at §491.12:] (1) Training program. The [facility] must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the [facility] must conduct training on the updated policies and procedures. *[For Hospices at §418.113(d):] (1) Training. The hospice must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing hospice employees, and individuals providing services under arrangement, consistent with their expected roles. (ii) Demonstrate staff knowledge of emergency procedures. (iii) Provide emergency preparedness training at least every 2 years. (iv) Periodically review and rehearse its emergency preparedness plan with hospice employees (including nonemployee staff), with special emphasis placed on carrying out the procedures necessary to protect patients and others. (v) Maintain documentation of all emergency preparedness training. (vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures. *[For PRTFs at §441.184(d):] (1) Training program. The PRTF must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) After initial training, provide emergency preparedness training every 2 years. (iii) Demonstrate staff knowledge of emergency procedures. (iv) Maintain documentation of all emergency preparedness training. (v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures. *[For PACE at §460.84(d):] (1) The PACE organization must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, contractors, participants, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Demonstrate staff knowledge of emergency procedures, including informing participants of what to do, where to go, and whom to contact in case of an emergency. (iv) Maintain documentation of all training. (v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures. *[For LTC Facilities at §483.73(d):] (1) Training Program. The LTC facility must do all of the following: (i) Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected role. (ii) Provide emergency preparedness training at least annually. (iii) Maintain documentation of all emergency preparedness training. (iv) Demonstrate staff knowledge of emergency procedures. *[For CORFs at §485.68(d):](1) Training. The CORF must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. All new personnel must be oriented and assigned specific responsibilities regarding the CORF’s emergency plan within 2 weeks of their first workday. The training program must include instruction in the location and use of alarm systems and signals and firefighting equipment. (v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures. *[For CAHs at §485.625(d):] (1) Training program. The CAH must do all of the following: (i) Initial training in emergency preparedness policies and procedures, including prompt reporting and extinguishing of fires, protection, and where necessary, evacuation of patients, personnel, and guests, fire prevention, and cooperation with firefighting and disaster authorities, to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. (iii) Maintain documentation of the training. (iv) Demonstrate staff knowledge of emergency procedures. (v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures. *[For CMHCs at §485.920(d):] (1) Training. The CMHC must provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. The CMHC must demonstrate staff knowledge of emergency procedures. Thereafter, the CMHC must provide emergency preparedness training at least every 2 years. This Standard is not met as evidenced by: Based on review of the Agency’s staff in-service binders, and staff interviews, it was determined the Agency failed to ensure staff received training pertaining to the Agency’s Emergency Operations Plan. This has the potential to affect all Pts. that receive service from the Agency. Findings include: 1. On 4/8/25, the staff in-service binders for 2023 and 2024 were reviewed. The binders lacked documentation that any staff received education on the Agency’s Emergency Operations Plan. On 4/7/25 at 11:00 AM, a request was made to review in-services provided in 2025; however no in-service binder was provided for 2025. 2. During staff interviews with the Administrator and QAPI Nurse on 4/9/25 at 9:30 AM, both confirmed the Agency failed to ensure staff received training pertaining to the Agency’s Emergency Operations Plan.”

“Encoding and transmitting OASIS CFR(s): 484.45(a) Standard: An HHA must encode and electronically transmit each completed OASIS assessment to the CMS system, regarding each beneficiary with respect to which information is required to be transmitted (as determined by the Secretary), within 30 days of completing the assessment of the beneficiary. This Standard is not met as evidenced by: Based on review of the Error Summary report and staff interviews, it was determined that in of 5541 of 12587 reports submitted for the last 12 months, the Agency failed to submit a timely report, resulting in a warning. Findings include: 1. The Error Summary report for 3/1/24 to 3/26/25 (12 months), was reviewed on 4/7/25. The report included a warning for Error # -3330. The Error included 5541 (44.02 %) of 12587 assessments that were submitted late. 2. During staff interviews with the Administrator and QA RN, on 4/9/25 at 12:00 PM, the administrative team confirmed the above findings.”

“Plan of care CFR(s): 484.60(a)(1) Each patient must receive the home health services that are written in an individualized plan of care that identifies patient-specific measurable outcomes and goals, and which is established, periodically reviewed, and signed by a doctor of medicine, osteopathy, or podiatry acting within the scope of his or her state license, certification, or registration. If a physician or allowed practitioner refers a patient under a plan of care that cannot be completed until after an evaluation visit, the physician or allowed practitioner is consulted to approve additions or modifications to the original plan. This Standard is not met as evidenced by: Based on a review of clinical records, and staff interviews, it was determined that in 3 of 7 (Pts. #1, 7, and 4) clinical records reviewed, the Agency failed to ensure staff provide service indicated in the POC; and the Physician review and sign the initial POC. 3. Pt. #4 was admitted to home health services on 3/3/25 with the principal diagnosis of Pressure Ulcer of Left hip, stage 3. The clinical record was reviewed on 4/8/25. The clinical record included the POC effective 3/3/25 that required SN Frequency: “2wk9”. As of 04/10/25, the record lacked documentation the SN provided service during the week of 3/23/25 to 3/29/25 and 3/30/25 to 4/5/25. 4. During staff interviews with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN, on 4/9/25 from 10:00 AM to 12:00 PM, it was confirmed the Agency failed to ensure staff provided service indicated in POC, and that the Physician reviewed and signed the initial POC. Findings include: 1. Pt. #1 was admitted for home health services on 2/11/25 with the diagnoses Essential (Primary) Hypertension and Type 2 Diabetes Mellitus with Diabetic neuropathy, Unspecified. The clinical record was reviewed on 4/8/25. The record included the POC effective 2/11/25 that required, “SN Frequency: 1wk9”. As of 4/8/25, the record lacked documentation the SN provided service during the week of 2/23/25 to 3/1/25. The POC effective 2/11/25 required, “… SN Frequency: 1wk9… SN to assess diabetic status…” The weekly SN visit note dated 2/17/25 lacked documentation the SN assessed the patient’s diabetic status. 2. Pt. #7 was admitted for home health services on 4/13/24 with the diagnoses of Other Fracture of Right femur, Subsequent for Closure Fracture with Routine Healing; Multiple Fracture of Ribs, Right Side and Left Side, Subsequent for Fracture with Routine Healing; and Pressure Ulcer of Left Buttock, Stage 4. The closed clinical record was reviewed on 4/8/25. The record included the POC for the certification period of 4/13/24 to 6/11/24. As of 4/8/25, the POC lacked the Physician’s signature to indicate the Physician reviewed and approved the POC. During an interview with the Administrator on 4/10/25 at 10:00 AM, the Administrator stated the Agency require the POC to be reviewed and signed by the Physician within 30 days of the effective date of the POC. The POC effective 4/13/24 required the SN to provide service “1week9”. The record lacked documentation the SN provided service during the weeks of 4/14/24 to 4/20/24 and 4/21/24 to 4/27/24, or a reason for the missed visits.”

“HHA administrator contact information CFR(s): 484.50(a)(1)(ii) (ii) Contact information for the HHA administrator, including the administrator’s name, business address, and business phone number in order to receive complaints. This Element is not met as evidenced by: Based on review of the Agency’s Pt. admission folder, observation during home visits, clinical record reviews, and staff interviews, it was determined that in 7 of 7 (Pts. #1, 2, 3, 4, 5, 6, and 7) clinical records reviewed, the Agency failed to provide the Pt./patient’s representative information regarding the Administrator. Findings include: 1. The Pt. admission folder was reviewed on 4/7/25. The folder lacked the Administrator’s name, address, and phone number to file a complaint and/or grievance. 2. The following home visits were conducted on 4/7/25 and 4/8/25. Pt. #1 SOC 2/11/25. Pt. #2. SOC 12/5/24. Pt. #3. SOC 6/13/24. During the home visits, the Pt. admission folders were observed, and lacked the name and contact information of the new Administrator. During the home visit of Pt. #1, the Pt. was unable to locate the Pt. admission folder. 3. The following clinical records were reviewed on 4/7/25 and 4/8/25: Pt. #1. SOC 2/11/25. Pt. #2. SOC 12/5/24. Pt. #3. SOC 6/13/24. Pt. #4. SOC 3/3/25. Pt. #5. SOC 2/18/25. Pt. #6. SOC 8/1/24. Pt. #7. SOC 4/14/24 The clinical records lacked documentation that the Pt./patient’s representative was provided the name and contact of the Administrator to file a complaint or grievance. 4. During the entrance interview on 4/7/25 with the Administrator, and the Clinical Director; the Administrator stated she has been the Administrator almost 2 years. 5. During staff interviews with the Clinical Director and Assistant/Alternate Administrator on 4/9/25 at 12:00 PM, both confirmed the Agency failed to provide the Pt./patient’s representative information regarding the new Administrator.”

“Written notice within 4 business days CFR(s): 484.50(a)(4) Provide written notice of the patient’s rights and responsibilities under this rule and the HHA’s transfer and discharge policies as set forth in paragraph (d) of this section to a patient-selected representative within 4 business days of the initial evaluation visit. This Element is not met as evidenced by: Based on review of the Agency’s Pt. admission folder, observation during home visits, clinical record review and staff interviews, it was determined in 7 of 7 (Pts. #1, 2, 3, 4, 5, 6, and 7) clinical records reviewed, the Agency failed to provide Pts. information regarding the Agency’s transfer and discharge policies. Findings include: 1. The Pt. admission folder was reviewed on 4/7/25. The folder lacked documentation of the Agency’s transfer and discharge policies. 2. The following home visits were conducted on 4/7/25 and 4/8/25. Pt. #1 SOC 2/11/25. Pt. #2. SOC 12/5/24. Pt. #3. SOC 6/13/24. During the home visits, on 04/7/25 and 4/8/25 at 4:00 PM, the Pt. admission folders were reviewed and lacked the information regarding the Agency’s transfer and discharge policies. During the home visit of Pt. #1, the Pt. was unable to locate the Pt. admission folder. 3. The clinical records of the following Pts. were reviewed on 4/7/25 and 4/8/25. Pt. #1. SOC 2/11/25. Pt. #2. SOC 12/5/24. Pt. #3. SOC 6/13/24. Pt. #4. SOC 3/3/25. Pt. #5. SOC 2/18/25. Pt. #6. SOC 8/1/24. Pt. #7. SOC 4/14/24. The records lacked documentation the Agency provided Pts. information, regarding the Agency’s policies pertaining to transfer and discharge. 4. During interview with the Administrator and the Assistant/Alternate Administrator on 4/9/25 at 11:00 AM, it was confirmed the Pt. admission folder reviewed is used for all Pts. admitted to this Agency, and that the Agency failed to provide Pts. information regarding the Agency’s transfer and discharge policies.”

“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 review of clinical records, observation during home visits, and staff interviews, it was determined in 7 of 7 (Pts. #1, 2, 3, 4, 5, 6, and 7) clinical records reviewed, the Agency failed to ensure Pts. were informed in writing of the disciplines to provide care/service, and/or the frequency of visits provided by each discipline. Findings include: 1. The following clinical records were reviewed 4/7/25 and 4/8/25. Pt. #1. SOC 2/11/25. Pt. received SN, and PT services. Pt. #2. SOC 12/5/24. Pt. received SN services. Pt. #3. SOC 6/13/24. Pt. received SN, and HHA services. Pt. #4. SOC 3/3/25. Pt. received SN services. Pt. #5. SOC 2/18/25. Pt. received SN, and HHA services. Pt. #6. SOC 8/1/24. Pt. received SN services. Pt. #7. SOC 4/14/24. Pt. received SN services. The records lacked documentation that the Pt. or legal guardian was notified in writing of the services to be provided and the frequency. 2. The following home visits were conducted on 4/7/25 and 4/8/25. Pt. #1 SOC 2/11/25. Pt. #2. SOC 12/5/24. Pt. #3. SOC 6/13/24. During the home visits, on 04/7/25 and 4/8/25, the Pt. admission folders were reviewed, and lacked documentation the Agency had provided Pts. information, regarding the frequency provided by each discipline. During the home visit of Pt. #1, the Pt. was unable to locate the Pt. admission folder. 3. During interview with the Administrator, Clinical Director, Assistant Administrator, QAPI Nurse, QA RN and QA Clerk, on 4/9/25 from 10:00 AM to 12:00 PM, the Administrator confirmed the Agency failed to specify all disciplines who provide services.”

“Advise the patient of discharge for cause CFR(s): 484.50(d)(5)(i) (i) Advise the patient, representative (if any), the physician(s) or allowed practitioner(s), issuing orders for the home health plan of care, and the patient’s 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) that a discharge for cause is being considered; This Element is not met as evidenced by: Based on a review of clinical records, Agency policy, and staff interview, it was determined in 1 of 7 (Pt. #7) clinical records reviewed, the Agency failed to ensure the Pt., and the patient’s care provider were notified of the Agency discharge. Findings include: 1. Pt. #7 was admitted for home health services on 4/13/24 with the diagnoses of Other Fracture of Right femur, Subsequent for Closure Fracture with Routine Healing; Multiple Fracture of Ribs, Right Side and Left Side, Subsequent for Fracture with Routine Healing; and Pressure Ulcer of Left Buttock, Stage 4. The closed clinical record was reviewed on 4/8/25. The record included a POC for the certification period of 4/13/24 to 6/11/24. The record included documentation the SN initiated service on 4/13/24. No other services were provided after 4/13/24. The Agency’s Discharge Non-Visit assessment form was completed by the SN on 4/30/24. The record lacked documentation the RN notified the Pt., referral source, or the patient’s Physician of plans to discharge Pt. #7 prior to 4/30/24. 2. The Agency policy titled, “Discharge/ Transfer/ Referral of Patients” was reviewed on 4/8/25. The policy required; “... The patient, family… shall be an active participant, when possible, in planning his/her… discharge…” 3. During a staff interview with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN on 4/10/25 at 10:00 AM, the Administrator confirmed the Agency failed to notify the Pt. and/or the patient’s care providers of the pending Agency discharge.”

“Provide contact info other services CFR(s): 484.50(d)(5)(iii) (iii) Provide the patient and representative (if any), with contact information for other agencies or providers who may be able to provide care; and This Element is not met as evidenced by: Based on a review of clinical records, Agency policy, and staff interview, it was determined in 1 of 7 (Pt. #7) clinical records reviewed, the Agency failed to present the Pt. with referral sources to continue care and services, prior to the Agency discharge. Findings include: 1. Pt. #7 was admitted for home health services on 4/13/24 with the diagnoses of Other Fracture of Right femur, Subsequent for Closure Fracture with Routine Healing; Multiple Fracture of Ribs, Right Side and Left Side, Subsequent for Fracture with Routine Healing; and Pressure Ulcer of Left Buttock, Stage 4. The closed clinical record was reviewed on 4/8/25. The record included the Physicians Face to Face Encounter form that contained documentation the Pt. had a Pressure Ulcer Stage 4, wheelchair bound, had problems with musculoskeletal issues, and required home health services by a SN, PT and OT. The SN initiated service on 4/13/24 and completed the Agency’s SOC assessment form that contained a section titled, “Plan of Care: Discipline Orders and Treatment” which included; “… SN to assess other co-morbidities including Pressure ulcer of left buttock, stage 4”. The record lacked documentation that any other SN services were provided after 4/13/24. On 4/30/24, the SN completed the Agency’s Discharge assessment form that contained; “… Patient is discharged to all home health services effective today due to no clinicians available in the area.” As of 4/8/25, the record lacked documentation that any discharge planning was conducted with the Pt. or that the Pt. was provided with other referral sources to continue care and services in the home. 2. The Agency policy titled, “Discharge/ Transfer/ Referral of Patients” was reviewed on 4/8/25. The policy required; “... The patient’s continuing care, treatment and service needs shall be assessed at discharge… Patients who have continuing care needs shall… Be informed of available community resources that can be utilized to meet those needs… 3. During a staff interview with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN on 4/10/25 at 10:00 AM, the Administrator confirmed the Agency failed to ensure the Pt. was provided with referral sources to continue care and services, prior to the Agency discharge.”

“Document efforts to resolve problems CFR(s): 484.50(d)(5)(iv) (iv) Document the problem(s) and efforts made to resolve the problem(s), and enter this documentation into its clinical records; This Element is not met as evidenced by: Based on a review of clinical records, Agency policy, and staff interview, it was determined in 1 of 7 (Pt. #7) clinical records reviewed, the Agency failed to address Pt. issues, prior to Agency discharge. Findings include: 1. Pt. #7 was admitted for home health services on 4/13/24 with the diagnoses of Other Fracture of Right femur, Subsequent for Closure Fracture with Routine Healing; Multiple Fracture of Ribs, Right Side and Left Side, Subsequent for Fracture with Routine Healing; and Pressure Ulcer of Left Buttock, Stage 4. The closed clinical record was reviewed on 4/8/25. The record included the Discharge Order completed by the SN and dated 4/30/24, “Please discharge patient form all… services. Patient refused services.” The Discharge assessment completed by the same SN and dated 4/30/24 included, “Condition at Discharge Unchanged (document re: reason for DC, challenges). Discharge Narrative Patient is discharged to all home health services effective today due to no clinicians available in the area.” The record contained conflicting reasons for the Agency discharge. As of 4/8/25, the record lacked documentation that the health care providers (Nurse Practitioner/referral source, and/or the Physician (identified on the POC) were notified of challenges or issues encountered with providing care to the Pt. 2. The Agency policy titled, “Discharge/ Transfer/ Referral of Patients” was reviewed on 4/8/25. The policy required; “... Patient Requests discontinuation of Service: The Clinical Supervisor/Case Manager shall be notified of the patient/legal representative’s request and shall contact the patient/legal representative to: Attempt to resolve the situation… Inform… of any adverse consequences that may result from the discontinuation of care, treatment of services. Provide information regarding other sources of care/treatment of services… The referring physician and all physician(s) involved in the patient’s Plan of Care shall be notified… All instructions/communications/interventions relevant to the patient’s/legal representative’s request for discontinuation of care, treatment, and/or services shall be documented in the patient’s medical record…” 3. During a staff interview with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN on 4/10/25 at 10:00 AM, the Administrator confirmed the Agency failed to address and document Pt. issues, prior to Agency discharge.”

“Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient’s mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This Element is not met as evidenced by: Based on clinical record reviews, policy review and staff interviews, it was determined for 3 of 7 (Pts. #6, 7, and 3) clinical records reviewed, the Agency failed to ensure PsOC included all the requirements. 3. Pt. #3 was admitted to home health services on 6/13/24 with the principal diagnosis of Type 2 Diabetes Mellitus without complications. The SN visit notes dated 2/10/25, 2/18/25, 2/25/25, 3/5/25, 3/10/25, 3/17/25, 3/25/25 and 4/3/2 included “Dialysis, patient had surgery for peritoneal dialysis catheter insertion last 2/5/25”. The POC effective 2/8/25 lacked instructions for care and maintenance of the peritoneal catheter. The POC dated 2/8/25 required the SN to provide service “1 wk 9”. The POC lacked a description or instructions for the peritoneal catheter and pertinent diagnosis to dialysis treatment. 4. The above findings were confirmed, during staff interviews with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN, on 4/9/25 from 10:00 AM to 12:00 PM. Findings include: 1. Pt. #6 was admitted for home health services on 8/1/24 with the diagnoses of Stage 3 Pressure Ulcer of Sacral Region and Subsequent Encounter Unspecified Injury of Head. The closed clinical record was reviewed on 4/7/25. The record included the POC for the certification period of 8/1/24 to 9/24/24. The POC required, “SN to perform wound care to right lateral chest. Cleanse wound with solution, using aseptic technique. SN to perform wound care to trauma/laceration in forehead. Cleanse wound with solution, apply dressing, cover and secure with application… SN to perform pressure ulcer care to coccyx/sacral region, stage 3. Cleanse/irrigate wound with solution, apply dressing cover and secure with application, using aseptic technique.” The POC lacked the type of solution to cleanse the wounds, type of dressing to apply, and the frequency to provide the wound care. 2. Pt. #7 was admitted for home health services on 4/13/24 with the diagnoses of Other Fracture of Right femur, Subsequent for Closure Fracture with Routine Healing; Multiple Fracture of Ribs, Right Side and Left Side, Subsequent for Fracture with Routine Healing; and Pressure Ulcer of Left Buttock, Stage 4. The closed clinical record was reviewed on 4/8/25. The record included the POC for the certification period of 4/13/24 to 6/11/24. The POC required, “SN to assess other comorbidities including Pressure ulcer of left buttock, stage 4.” The POC lacked any wound care instructions for treatment of the left buttock. The Physician Face-to-Face Encounter signed by the Nurse Practitioner and dated 4/11/24 included, “… Home Health Services Requested… PT to evaluate and treat. OT to evaluate and treat”. The POC effective 4/13/24 lacked the order for PT and OT to evaluate and treat.”

“Influenza and pneumococcal vaccines CFR(s): 484.60(b)(2) Influenza and pneumococcal vaccines may be administered per agency policy developed in consultation with a physician, physician assistant, nurse practitioner, or clinical nurse specialist, and after an assessment of the patient to determine for contraindications. This Element is not met as evidenced by: Based on a review of clinical records, Agency policy, and staff interviews, it was determined that in 3 of 7 (Pts. #1, 2, and 6) clinical records reviewed, the Agency failed to assess Pt. Influenza and Pneumococcal vaccine status at the SOC, as required by the Agency. Findings include: 1. The following clinical records were reviewed on 4/7/25 (1:00 PM and 3:30 PM), 4/8/25 (9:30 AM): Pt. #1. SOC 2/11/25. Pt. #2. SOC 12/5/24. Pt. #6. SOC 8/1/24. The clinical records lacked documentation the staff inquired regarding the patient’s Influenza and Pneumonia status at the SOC. 2. The Agency’s policy titled; “Vaccinations” was reviewed on 4/9/25 at 3:20 PM. The policy included, “… A. Influenza… 5. The following shall be considered for documentation: a. Individual client/patient record entries identifying the assessment for the need of vaccination… b. Standardized check-off form recording client/patient specific vaccination, including the assessment for the need of the vaccination; date of offer or referral; client/patient response, administration, contraindication or refusal; and any follow-up activities… B. Pneumococcal Pneumonia… 5. The following shall be considered for documentation: a. Individual client/patient record entries identifying the assessment for the need of vaccination…” 3. During an interview with the Administrator and Clinical Director on 4/7/24 at 11:00 AM, the Administrator stated the during the SOC visit the staff are required to inquiry the patient’s vaccination status for the Influenza and Pneumonia vaccines, and this information is documented in the SOC assessment form. During an interview with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN on 4/10/25 from 10:00 AM to 12:00 PM, the Administrator confirmed the Agency failed to assess Pt. Influenza and Pneumococcal vaccine status at the SOC.”

“Name/contact information of clinical manager CFR(s): 484.60(e)(5) Name and contact information of the HHA clinical manager. This Element is not met as evidenced by: Based on review of the Agency’s Pt. admission folder and staff interviews, it was determined in 7 of 7 (Pts. #1, 2, 3, 4, 5, 6, and 7) the Agency failed to provide information regarding the Agency Supervisor (Clinical Director) and their contact information. 1. The Agency Pt. admission folder was reviewed on 04/7/25. The folder lacked information identifying the Agency Supervisor’s name and contact information. 2. The clinical records of the following Pts. were reviewed from 4/22/24 to 4/23/24: Pt. #1. SOC 2/11/25. Pt. #2. SOC 12/5/24. Pt. #3. SOC 6/13/24. Pt. #4. SOC 3/3/25. Pt. #5. SOC 2/18/25. Pt. #6. SOC 8/1/24. Pt. #7. SOC 4/14/24. The clinical records reviewed lacked information identifying the Clinical Director/ Agency Supervisor’s name and contact information. 3. The following home visits were conducted on 4/7/25 and 04/8/25. Pt. # 1. SOC 2/11/25 Pt. #2. SOC 12/5/24. Pt. #3. SOC 6/13/24. 4. During the home visits, on 4/7/25 and 4/8/25 at 4:00 PM, the Pt. admission folders were reviewed. The folders lacked the name and contact information of the Clinical Director/Agency Supervisor. During the home visit of Pt. #1, the Pt. was unable to locate the Pt. admission folder. 5. During a staff interview with the Administrator and Alternate/Assistant Administrator, on 4/9/25 at 12:00 PM, it was confirmed the same admission folder is given to all Pts. The administrative staff confirmed the Agency failed to identify the Clinical Director’s/Agency Supervisor name.”

“Required items in clinical record CFR(s): 484.110(a)(1) The patient’s current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical notes, plans of care, and physician or allowed practitioner orders; This Element is not met as evidenced by: Based on a review of clinical records, Agency policy, and staff interview, it was determined in 1 of 7 (Pt. #7) clinical records reviewed, the Agency failed to ensure that documentation entered into the clinical record was complete. Findings include: 1. Pt. #7 was admitted for home health services on 4/13/24 with the diagnoses of Other Fracture of Right femur, Subsequent for Closure Fracture with Routine Healing; Multiple Fracture of Ribs, Right Side and Left Side, Subsequent for Fracture with Routine Healing; and Pressure Ulcer of Left Buttock, Stage 4. The closed clinical record was reviewed on 4/8/25 at 9:45 AM. The record included the SOC assessment form completed by the SN and contained, “SN to assess other comorbidities including Pressure ulcer of left buttock, stage 4.” The SOC assessment form lacked a description of the pressure ulcer, or documentation that the SN assessed the pressure ulcer. 2. The Agency’s policy titled; “Wound Care Policy” was reviewed on 4/10/25 at 10:55 AM. The policy required, “…Initial Wound Assessment 1. A comprehensive wound assessment shall be completed by a qualified clinician within 24 hours of admission to service… 2. The initial assessment shall include… 8. Wound characteristics: Location. Dimensions (length, width, depth). Wound bed characteristics (tissue type, color), Exudate (amount, color, consistency). Odor. Periwound skin condition. Signs of infection. Undermining or tunneling. Stage/classification (for pressure injuries) … Documentation Requirements Initial Documentation 1. Comprehensive wound assessment 2. Wound etiology and classification 3. Treatment plan including: Cleansing method. Debridement method (if applicable). Primary dressing. Secondary Dressing. Frequency of dressing changes. Topical treatments. Pain management plan. 4. Patient/caregiver education provided. 5. Physician/provider notification and orders.” 3. During staff interviews with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN on 4/10/25 at 10:00 AM, the Administrator confirmed the Agency failed to ensure that documentation entered into the clinical record was complete.”

“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 a review of clinical records and staff interview, it was determined that in 1 of 2 (Pt. #7) closed clinical records reviewed, the Agency failed to ensure the Physician was sent a copy of the discharge summary. Findings include: 1. Pt. #7 was admitted for home health services on 4/13/24 with the diagnoses of Other Fracture of Right femur, Subsequent for Closure Fracture with Routine Healing; Multiple Fracture of Ribs, Right Side and Left Side, Subsequent for Fracture with Routine Healing; and Pressure Ulcer of Left Buttock, Stage 4. The closed clinical record was reviewed on 4/8/25 at 9:45 AM. The record included the discharge summary completed by the SN and dated 4/30/24. The record lacked documentation that a copy of the summary was sent to the Physician. 2. During staff interviews with the Administrator, Clinical Director, Assistant/Alternate Administrator, QAPI Nurse, QA Clerk-485 tracking, and the QA RN on 4/10/25 at 10:00 AM, the Administrator confirmed the Agency failed to send a copy of the discharge summary to the Physician.”