Every finding on record at International Consulting Group, Inc.

The Emergency Preparedness requirements were evaluated, in conjunction with the recertification survey, on 02/28/25. The Agency was in compliance with the Condition, 42 CFR 484.22, Establishment of the Emergency Program for this survey.

A recertification survey was conducted in conjunction with the evaluation of Emergency Preparedness requirements on 02/28/25. Standard level deficiencies cited. Abbreviations: # = number AM = morning POC/PsOC = Plan of care/ Plans of Care SOC = Start of care PM = afternoon/evening Pt./ Pts. = Patient/Patients ml = milliliter NS = Normal Saline CADD = Continuous Ambulatory Drug Delivery mg = milligrams IV = Intravenous

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 records review and Staff interview, it was determined that in 3 of 7 (Pts # 1, 3 and 2) the Agency failed to ensure that the Plans of Care (PsOC) contained patient specific interventions orders. 3. Pt. #2 was admitted to Home Health Services on 12/30/24 with the diagnosis of Fabry (Anderson) Disease. The clinical record was reviewed 02/25/25. The POC effective 12/30/24 to 02/27/25 with intravenous infusion orders: “SN INFUSION THERAPY INTERVENTIONS:….Administer Fabrazyme 70 mg in 100 ml of 0.9 NS every 2 weeks via CADD Pump via peripheral IV….Insert peripheral access device to initiate infusion….” The POC lack the patient specific orders/ interventions on type/size of peripheral IV access device used. 4. During interviews with the Administrator, Clinical Director and Clinical Manager on 02/26/25 between 1:00 PM to 2:45 PM, the Clinical Director and Clinical Manager confirmed the above findings. Findings include: 1. Pt. # 1 was admitted to Home Health Services on 03/04/24 with diagnosis of Mucopolysaccharidoses. The clinical record was reviewed on 02/25/25. The clinical record contained a POC for certification period 12/29/24 to 02/26/25 with intravenous infusion orders “infusion to be via implanted port”. The POC lacked patient specific orders on type of implanted port, size and type of needle to be used. 2. Pt. # 3 was admitted to Home Health Services on 12/06/24 with diagnosis of Fabry (Anderson) Disease. The clinical record was reviewed on 02/25/25. The clinical record contained a POC for certification period 12/06/24 to 02/03/25 with orders for intravenous medication Fabrazyme 70 mg every 2 weeks. The POC lacked dilution solution amount, description of infusion (gravity or intravenous pump) and rate / length of time of infusion. Pt # 3 POC also contained orders to infuse intravenous medication via “peripheral access device”. The POC lacked description orders on the use of peripheral access device.

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 clinical records review and Staff interview, it was determined that in 2 of 4 (Pt. #5 and 7) closed records reviewed, the Agency failed to ensure that a discharge summary was sent to the Physician within 5 days of discharge. Findings include: 1. Pt. # 5 was admitted to Home Health Services on 12/11/24 with the Diagnosis of Malignant Neoplasm of Unspecified Part of Right Bronchus or Lung. The clinical record was reviewed on 02/25/25. The last visit by the Physical Therapy was dated 02/06/25. The Physical Therapy Discharge/ Transfer summary, dated 02/10/25, indicated Pt. #5 passed away. The discharge summary was sent more than 5 days after discharge. 2. Pt. # 7 was admitted to Home Health Services on 01/0524 with the Diagnosis of Encounter for Antineoplastic Chemotherapy. The clinical record was reviewed on 02/26/25. The discharge orders dated 02/05/24, indicated: “….Patient done with chemo treatment, discharged from home services as of 02/2/24….” The Discharge/Transfer summary, dated 02/02/24, indicated Pt. #7 discharged from Chemo therapy. As of 02/26/25, the discharge summary was not sent to the Physician. 3. During an interview with the Administrator, Clinical Director and Clinical Manager on 02/26/25 at 1:00 PM, the Clinical Director confirmed the above findings.

Recertification survey completed. Standard level deficiencies cited. Abbreviations: Pt./Pts. = Patient/Patients SOC = Start of Care PsOC = Plans of Care AM = Morning PM = Afternoon/ Evening MG = Milligrams ML/mL = milliliters chemo = Chemotherapy med = Medication E = Employee SN = Skilled Nurse # = Number PT = Physical Therapist

HHA Comprehensive Assessment in Disaster CFR(s): 484.102(b)(1) §484.102(b)(1) Condition for Participation: [(b) Policies and procedures. The HHA 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. At a minimum, the policies and procedures must address the following:] (1) The plans for the HHA's patients during a natural or man-made disaster. Individual plans for each patient must be included as part of the comprehensive patient assessment, which must be conducted according to the provisions at §484.55. This STANDARD is not met as evidenced by: A. Based on a review of clinical records, Agency policy and staff interview, it was determined the Agency failed to incorporate individualized Emergency Preparedness planning into the comprehensive assessment. This was found in 5 of 5 (Pts. #1, 2, 3, 4 and 5) clinical records reviewed. Findings include: 1. The following clinical records were reviewed from 12/13/21 (1:45 PM) to 12/15/21 (11:30 AM): Pt. #1. SOC 9/2/21 Pt. #2. SOC 6/23/21 Pt. #3. SOC 10/14/20 Pt. #4. SOC 12/9/21 Pt. #5. SOC 1/5/15 The records contained the SOC comprehensive assessment completed by a SN or PT which included the section titled, “Safety Measures Triage/Risk Code (Agency specific): Disaster Code (Agency specific)”. This section was left blank. Pts. #1 to 5 lacked documentation that Emergency Preparedness planning was included in the comprehensive assessments. 2. The Agency policy titled, “Emergency Operations Plan and Policies” was reviewed on 12/16/21 at 10:30 AM. The policy required: “…5. Mitigation activities… Developing an individual emergency preparedness plan for each patient as part of the comprehensive assessment… 11…At the time of admission, each patient’s acuity or priority level is determined. Level 1 patients are high priority patients…” 3. During an interview with the Administrator and Clinical Director on 12/15/21 at 2:00 PM, the Clinical Director confirmed the Agency staff failed to incorporate, individualized Emergency Preparedness planning into the comprehensive assessment.

Names and Contact Information CFR(s): 484.102(c)(1) §403.748(c)(1), §416.54(c)(1), §418.113(c)(1), §441.184(c)(1), §460.84(c)(1), §482.15(c)(1), §483.73(c)(1), §483.475(c)(1), §484.102(c)(1), §485.68(c)(1), §485.625(c)(1), §485.727(c)(1), §485.920(c)(1), §486.360(c)(1), §491.12(c)(1), §494.62(c)(1). [(c) The [facility must develop and maintain an emergency preparedness communication plan that complies with Federal, State and local laws and must be reviewed and updated at least every 2 years [annually for LTC facilities]. The communication plan must include all of the following:] (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [facilities]. (v) Volunteers. *[For Hospitals at §482.15(c) and CAHs at §485.625(c)] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians (iv) Other [hospitals and CAHs]. (v) Volunteers. *[For RNHCIs at §403.748(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Next of kin, guardian, or custodian. (iv) Other RNHCIs. (v) Volunteers. *[For ASCs at §416.45(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For Hospices at §418.113(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Hospice employees. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Other hospices. *[For HHAs at §484.102(c):] The communication plan must include all of the following: (1) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Patients' physicians. (iv) Volunteers. *[For OPOs at §486.360(c):] The communication plan must include all of the following: (2) Names and contact information for the following: (i) Staff. (ii) Entities providing services under arrangement. (iii) Volunteers. (iv) Other OPOs. (v) Transplant and donor hospitals in the OPO's Donation Service Area (DSA). This STANDARD is not met as evidenced by: A. Based on review of the Agency's Emergency Preparedness plan and staff interview, it was determined the Agency failed to ensure the communication plan was complete. This has the potential to affect all Pts. receiving services from the Agency. Findings include: 1. The Emergency Preparedness plan dated 4/2/20 was reviewed on 12/13/21 at 2:00 PM. On 12/15/21 at 11:00 AM, the Clinical Director presented the Agency’s communication plan which contained: “Section I: Introduction to the Emergency Preparedness Plan” and included “Key Contacts Information”. The communication plan lacked the following names and contact information of the direct employees: E #1. Registered Nurse E #2. Registered Nurse E #3. Registered Nurse E #4. Registered Nurse E #5. Occupational Therapist E #6. Physical Therapist E #8. Physical Therapy Assistant E #9. Speech Therapist E #10. Licensed Clinical Social Worker and the names and contact information of Patient’s physicians of Pts. #1 to 5: Pt. #1. SOC 9/2/21 Pt. #2. SOC 6/23/21 Pt. #3. SOC 10/14/20 Pt. #4. SOC 12/9/21 Pt. #5. SOC 1/5/15 2. During an interview with the Administrator and Clinical Director on 12/15/21 at 2:00 PM, the Clinical Director confirmed the communication plan lacked the names of contact information of direct employees indicated above and Patient’s physicians.

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), §485.625(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, 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: A. Based on review of the Agency's Emergency Preparedness Plan and staff interview, it was determined the Agency failed to conduct Emergency Preparedness testing exercises. This has the potential to affect all Pts. receiving service from the Agency. Findings include: 1. The Emergency Preparedness plan dated 4/2/20 was reviewed on 12/13/21 at 2:00 PM. The Plan lacked documentation the Agency conducted any testing of its Emergency Preparedness Plan in 2019, 2020 and 2021. 2. During an interview with the Clinical Director on 12/13/21 at 2:00 PM, the Clinical Director confirmed the Agency failed to conduct any Emergency Preparedness testing exercises in 2019, 2020 and 2021. 3. During an interview with the Administrator and Clinical Director on 12/15/21 at 2:00 PM, both confirmed the Agency failed to conduct any Emergency Preparedness testing exercises from 2019 to the present date.

Recertification survey completed. Standard level deficiencies cited. Abbreviations: Pt./Pts. = Patient/Patients SOC = Start of Care PsOC = Plans of Care AM = Morning PM = Afternoon/ Evening MG = Milligrams ML/mL = milliliters chemo = Chemotherapy med = Medication E = Employee SN = Skilled Nurse # = Number PT = Physical Therapist

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: A. Based on a review of clinical records, Agency policy and staff interview, it was determined the Agency failed to ensure the comprehensive assessment was updated. This was found in 1 of 5 (Pt. #5) clinical records reviewed. Findings include: 1. Pt. #5. SOC 1/15/21. Primary Diagnosis: Unspecified Malignant Neoplasm of Colon. The clinical record was reviewed on 12/14/21 at 2:00 PM. The record contained “Physician Orders” dated 10/9/21 which included: “…did not get treatment today. He will be on chemo break for awhile. Will let your office know with any update.” The last POC was for the certification period of 9/12/21 to 11/10/21 requiring SN service only. The last SN visit was provided on 9/24/21. As of 12/14/21, the record lacked documentation the SN updated the comprehensive assessment to discharge Pt. #5 from the Agency, indicating no skilled services were needed after 10/9/21. 2. The Agency policy titled, “Reassessments/Update of the Comprehensive Assessment” was reviewed on 12/16/21 at 10:00 AM. The policy required: “4. Each patient will be reassessed when…the patient’s health status that would warrant update and revision of the comprehensive assessment…” 3. During an interview with the Administrator and Clinical Director on 12/14/21 at 2:00 PM, the Clinical Director confirmed Pt. #5 did not require any skilled service after 10/9/21, and the Agency failed to ensure the comprehensive assessment was updated.

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: A. Based on a review of clinical records, interview during a home visit and staff interview, it was determined the Agency failed to ensure the PsOC were accurate. This was found in 1 of 5 (Pt. #1) clinical records reviewed. Findings include: 1. Pt. #1. SOC 9/2/21. Primary Diagnosis: Unspecified Malignant Neoplasm of Colon. The clinical record was reviewed on 12/13/21 at 1:45 PM. The record contained the PsOC for the certification period of 9/2/21 to 10/31/21 and effective 11/1/21 which included the medication “Pegfilgrastim (Neulasta) 6 MG/0.6 ML Subcutaneous every 14 days”. A home visit was conducted on 12/13/21 at 4:00 PM with E #3. During the home visit, the Pt. stated the Neulasta was discontinued “more than a year ago due to side-effects… I only had one dose.” The PsOC effective 9/2/21 and 11/1/21 were inaccurate to include Neulasta. 2. During an interview with the Administrator and Clinical Director on 12/15/21 at 2:00 PM, the Clinical Director confirmed the POC for Pt. #1 was inaccurate.

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: A. Based on clinical record review and staff interview, it was determined the Agency failed to ensure Pts. were screened at the SOC for the status of the Influenza and Pneumoccal Pneumonia vaccines. This was found in 3 of 5 (Pts. #4, 1, and 5) clinical records reviewed. 2. Pt. #1. SOC 9/2/21. Primary Diagnosis: Unspecified Malignant Neoplasm of Colon. The clinical record was reviewed on 12/13/21 at 1:45 PM. The record contained the SOC comprehensive assessment completed by the SN, and dated 9/2/21 which included the section titled: “Patient History and Diagnoses Immunization/Screening Tests - Flu Unknown, Pneumonia Unknown…” The assessment lacked documentation the SN offered the vaccines. 3. Pt. #5. SOC 1/15/21. Primary Diagnosis: Unspecified Malignant Neoplasm of Colon. The clinical record was reviewed on 12/14/21 at 2:00 PM. The record contained the SOC comprehensive assessment completed by the SN, and dated 1/15/2121 which included the section titled: “Patient History and Diagnoses Immunization/Screening Tests - Flu Yes, Pneumonia Unknown…” The assessment lacked the date the Pt. received the Flu vaccine, and that the Pneumonia vaccine was offered. 4. The Agency lacked a policy pertaining to the inquiry, administration and/or arrangement of the Flu (Influenza) and Pneumococcal Pneumonia vaccines for Pts. 5. During the entrance interview with the Clinical Director on 12/13/21 at 10:00 AM, the Clinical Director stated Agency staff inquire about the patient’s Influenza and Pneumococcal Pneumonia vaccines status during the SOC visit, and it is documented in the SOC comprehensive assessment form within the clinical record. 6. During an interview with the Administrator and Clinical Director on 12/15/21 at 2:00 PM, the question was asked: If a Pt. do not remember when or whether they had the Flu and Pneumonia vaccines, what should the nurse or therapist do? The Clinical Director replied: “They should document what is unknown, the date or year (the Pt. received the vaccine), the nurse did not document it, and then we offer them the vaccines.” 7. During an interview with the Administrator and Clinical Director on 12/14/21 at 2:00 PM, the Clinical Director confirmed Agency staff failed to conduct immunization screening, as required by the Agency. Findings include: 1. Pt. #4. SOC 12/9/21. Primary Diagnosis: Polyneuropathy, Unspecified. The clinical record was reviewed on 12/15/21 at 11:00 AM. The record lacked documentation the Pt. was screened at the SOC for the status of the Influenza and Pneumococcal Pneumonia vaccines.

Ensure clinical manager is available CFR(s): 484.105(b)(1)(iii) (iii) Ensure that a clinical manager as described in paragraph (c) of this section is available during all operating hours; This ELEMENT is not met as evidenced by: A. Based on observations, Agency policy, and staff interview, it was determined the Agency failed to ensure the Clinical Manager or the designated Alternate Clinical Manager was available during the Agency's operational business hours. This has the potential to affect all Pts. served by the Agency. Findings include: 1. During observations made during the course of the survey (12/13/21 through 12/16/21), neither the Clinical Manager/Director of Nursing nor the Alternate Clinical Manager were present at the Agency. 2. The Agency policy titled “Job Description: Clinical Manager” was reviewed on 12/15/21 at 11:30 AM. The policy required: “…The Clinical Manager is available at all times during operating hours (or appoints a similarly qualified alternate) and participates in all activities relevant to professional services furnished…Working Environment: Works indoors in Agency office and Patient homes and travels to/from Patient homes…” 3. During the entrance interview with the Clinical Director/Physical Therapist on 12/13/21 at 10:00 AM, the Clinical Director/Physical Therapist stated the Agency is open Monday through Friday, 9:00 AM to 5:00 PM. 4. During an interview with the Clinical Director/Physical Therapist on 12/15/21 at 12:30 PM, the Clinical Director/Physical Therapist confirmed the Clinical Manager/Director of Nursing and Alternate Clinical Manager would not be present throughout the course of the survey.