Every finding on record at Spectrum Nurses, Inc

The Emergency Preparedness requirements were evaluated, in conjunction with the recertification survey, on 07/23/25. The Agency was in compliance with the Condition, 42 CFR 484.102, Establishment of the Emergency Program for this survey.

A recertification survey was conducted in conjunction with the evaluation of Emergency Preparedness requirements on 07/23/25. Standard level deficiencies cited. Abbreviations: wk = week % = percent # = Number = less than > = greater than BP =Blood pressure SN = Skilled Nurse SOC = Start of care RN = Registered Nurse QA = Quality Assurance Pt./ Pts. = Patient/Patients OT = Occupational Therapy/Therapist OASIS = Outcome and Assessment Information Set

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 the review of the Agency’s Error Summary report and Staff interview, the Agency failed to submit timely reports for 88 of 655 reports submitted for the last 12 months. Finding include: 1. The Agency’s Error Summary report for 07/01/2024 through 06/30/2025, was reviewed on 07/22/25 at 10:10 AM. The report included 88 of 655 (13.52%) of the OASIS reports were not submitted timely, resulting in a warning. 2. The above findings were confirmed, during the interview with the Director of Nursing, on 07/22/25 between 11:30 AM and 2:00 PM.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: Based on a review of clinical records, and Staff interview, in 2 of 7 (Pts. #1 and 2) clinical records reviewed, the Agency failed to obtain a referral to initiate service. Findings include: 1. Pt. #1 was admitted for Home Health services on 05/15/25 with a diagnosis of, but not limited to Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 07/22/25. The Agency lacked a referral to initiate service on 05/15/25. 2. Pt. #2 was admitted for Home Health services on 06/30/20 with a diagnosis of, but not limited to Type 2 Diabetes Mellitus with Hyperglycemia. The clinical record was reviewed on 07/22/25. The Agency lacked a referral to initiate service on 06/30/20. 3. During an interview with the Director of Nursing, Nursing Supervisor and QA RN on 07/23/25 at 8:58 AM, all confirmed the Agency failed to initiate service within 48 hours of receipt of a referral.

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, Agency policy, and Staff interviews, in 5 of 7 (Pts. #1, 3, 4, 6, and 7) clinical records reviewed, the Agency failed to ensure Staff provide service, as required on the POC and ordered by the Physician. Findings include: 1. Pt. #1 was admitted for Home Health services on 05/15/25 with a diagnosis of, but not limited to Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 07/22/25. The clinical record included the POC for the certification period of 05/15/25 to 07/13/25. The POC required the SN to provide service “1wk9 …Notify physician of… Pulse greater than (>) 120 or less than () 180 or less than ( Diastolic BP greater than (>) 90 or less than ( The SN visit notes dated 06/03/25 and 06/10/25 included “BP 101/56”, the SN visit note dated 06/24/25 included “Pulse 55”. The record lacked documentation the SN notified the Physician for Pulse and BP outside the stated parameters in the POC. The SN “Missed Visit Form” competed by the SN and dated 05/27/25 lacked documentation the Physician was notified of the missed visit, or that the SN attempted to reschedule the visit during the week of 05/25/25 to 05/31/25. 2. Pt. 3 was admitted for Home Health services on 04/30/24 with a diagnosis of, but not limited to “Pulmonary Fibrosis, Unspecified. The clinical record was reviewed on 07/22/25. The clinical record included the POC for the certification period of 04/24/25 to 06/22/25 that required the SN to provide service "1wk9 … Notify physician of: Temperature greater than (>) 101 or less than ( Pulse greater than (>) 120 or less than (Systolic BP greater than (>) 180 or less than ( Diastolic BP greater than (>) 90 or less than ( The SN visit note dated 05/27/25 lacked documentation the SN assessed the patient’s temperature, pulse, or BP. The SN “Missed Visit Form” competed by the SN and dated 06/12/25 lacked documentation the Physician was notified of the missed visit, or that the SN attempted to reschedule the visit during the week of 06/08/25 to 06/14/25. 3. Pt. #4 was admitted to Home Health services on 10/14/24 with the diagnoses of Essential Hypertension and Type 2 Diabetes Mellitus without Complications. The clinical record was reviewed on 07/22/25. The clinical record included PsOC dated 04/07/25 and 06/06/25, that required the SN to assess the patient 1 time a week for 9 weeks. The SN failed to visit the weeks of 05/07/25 (week #5) and 05/14/25 (week #6). 4. Pt. #6 was admitted to Home Health services on 01/27/23 with the diagnoses of “Hyp Hrt & Chr Kdny Dis w Hrt Fail and stg 1-4/unsp chr kdny”. The clinical record was reviewed on 07/22/25. The clinical record included a POC dated 07/20/24, that required the OT to evaluate the patient. The OT evaluation included orders to assess the patient 1 time a week for 8 weeks. The OT failed to visit the weeks of 08/03/24 (week #2) and 09/05/24 (week #7). 5. Pt. #7 was admitted to Home Health services on 05/03/24 with the diagnosis of “Carcinoma in situ of rectosigmoid junction”. The clinical record was reviewed on 07/22/25. The clinical record included a POC dated 08/31/24, that required the SN to assess the patient 1 time a week for 9 weeks. The SN failed to visit the patient after 09/27/24. 6.The Agency’s policy titled “Missed Visit Report” was reviewed on 07/23/25 at 10:00 AM and included “…SPECIAL INSTRUCTIONS… 3. Notify the Physician and the Agency…” 7.The above findings were confirmed, during an interview with the Director of Nursing, Nursing Supervisor and QA RN on 07/23/25 between 8:58 AM and 11:30 AM.

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 and Staff interview, in 2 of 7 (Pts. #1, and 3) clinical records reviewed, the Agency failed to complete the assessment for Pt. Pneumonia and Influenza vaccines. Findings include: 1. Pt. #1 was admitted for Home Health services on 05/15/25 with a diagnosis of, but not limited to Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 07/22/25. The clinical record included the Agency’s form titled, “Influenza/Pneumonia Vaccine” completed by the SN and dated 05/15/25. The form lacked an inquiry regarding the need for the Pneumonia vaccine during the SOC visit. 2. Pt. #3 was admitted for Home Health services on 04/30/24 with a diagnosis of, but not limited to “Pulmonary Fibrosis, Unspecified. The clinical record was reviewed on 07/22/25. The clinical record included the SOC assessment form completed by the SN and dated 04/30/24. The form contained a section titled; “Most Recent Immunizations” that included an inquiry for the Pneumonia and Flu (Influenza) vaccines. The SN responded “No” to both vaccines. The form lacked documentation to indicate whether “No” was intended that the Pt. refused the vaccines, or the vaccines were not needed. 3. During the entrance interview with the Administrator, Director of Nursing, and Nursing Supervisor #1 on 07/21/25 at 1:00 PM, Nursing Supervisor #1 stated that an inquiry regarding the patient’s need for the Influenza and Pneumonia vaccines is initially conducted during the SOC visit and is documented in the SOC assessment form, and/or the vaccine form in the clinical record. 4. During an interview with the Director of Nursing, Nursing Supervisor and the QA RN on 07/23/25 at 8:58 AM, all confirmed the SN failed to complete the assessment for Pneumonia and/or Influenza vaccines during the SOC visits.

Services provided by HH aide CFR(s): 484.80(g)(2) A home health aide provides services that are: (i) Ordered by the physician or allowed practitioner; (ii) Included in the plan of care; (iii) Permitted to be performed under state law; and (iv) Consistent with the home health aide training. This ELEMENT is not met as evidenced by: Based on a review of clinical records, Agency policy, and Staff interview, in 1 of 3 (Pt. #1) clinical records reviewed wherein the Pt. received Home Health Aide services, the Agency failed to ensure the Home Health Aide followed the directions on the Home Health Aide Care Plan. Findings include: 1. Pt. #1 was admitted for Home Health services on 05/15/25 with a diagnosis of, but not limited to Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 07/22/25. The clinical record included the “Aide Care Plan” completed by the RN on 05/15/25. The Aide Care Plan included, “Vital Sign Notification… Pulse >120 The Home Health Aide visit notes dated 05/23/25 (Pulse 56), 06/23/25 (Pulse 52), 06/27/25 (Pulse 48), and 06/30/25 (Pulse 58), lacked documentation the Home Health Aide notified the RN and/or Agency of the Pulse rates outside the stated parameters in the Aide Care Plan. The Home Health Aide visit note dated 06/13/25 included, “Patient has some small skin abrasions near her right knee”. The Home Health Aide visit note dated 06/16/25 included “Skin tares near right knee”. The Home Health Aide visit notes/record lacked documentation the Home Health Aide notified the RN and/or Agency of the abrasions and skin tares. The SOC assessment form dated 05/15/25 and ROC assessment form dated 05/23/25, all completed by the RN; and weekly RN visit notes from 05/27/25 to 07/01/25 lacked documentation of any skin breakdown for Pt. #1. 2. The Agency policy titled; Home Health Aide Job Description” was reviewed on 07/23/25. The policy required, “… The Home Health Aide participates in caring for clients by… Recording care given, including observations and treatments; Informing supervisor of changes in client’s condition...” 3. During an interview with the Director of Nursing, Nursing Supervisor and the QA RN on 7/23/25 at 8:58 AM, Nursing Supervisor #1 stated the Home Health Aide is trained to notify either her or the Agency when new areas of skin breakdown is observed. During the same interview, the Director of Nursing and Nursing Supervisor confirmed the above findings.

Onsite supervisory visit every 14 days CFR(s): 484.80(h)(1)(i) (1)(i) If home health aide services are provided to a patient who is receiving skilled nursing, physical or occupational therapy, or speech language pathology services— (A) A registered nurse or other appropriate skilled professional who is familiar with the patient, the patient's plan of care, and the written patient care instructions described in paragraph (g) of this section, must complete a supervisory assessment of the aide services being provided no less frequently than every 14 days; and (B) The home health aide does not need to be present during the supervisory assessment described in paragraph (h)(1)(i)(A) of this section. This ELEMENT is not met as evidenced by: Based on a review of clinical records and Staff interviews, in 2 of 3 (Pts. #1 and 5) clinical records reviewed wherein the Pt. received Home Health Aide services, the Agency failed to ensure the RN conduct Home Health Aide supervision every 14 days. 2. Pt. #5 was admitted to the Home Health services on 04/22/25 with the diagnosis of Multiple Sclerosis. The clinical record was reviewed on 07/22/25. The clinical record included a POC dated 04/22/25, with Aide services 2 times a week for 9 weeks. The records lacked documentation of the Aide supervision by the RN in the patient’s home on 05/01/25 (week #3) and on the week of 07/16/25 (week #4). During the interview with the Director of Nurses, it was stated the supervision was conducted by telephone. 3. The above findings were confirmed, during an interview with the Director of Nursing, Nursing Supervisor and QA RN on 07/23/25 between 8:58 AM and 11:30 AM. Findings include: 1. Pt. #1 was admitted for Home Health services on 05/15/25 with a diagnosis of, but not limited to Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 07/22/25. The clinical record included the Home Health Aide visit notes for 1 to 2 times a week from 05/15/25 to 06/30/25 that indicated care was provided. The record lacked documentation the RN supervised the Home Health Aide from 05/15/25 to 06/30/25.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: Based on a review of clinical records, and Staff interviews, in 4 of 7 (Pts. #1, 3, 5 and 7) clinical records reviewed, the Agency failed to ensure the clinical records were complete and accurate. 3. Pt. #5 was admitted to the Home Health services on 04/22/25 with the diagnosis of Multiple Sclerosis. The clinical record was reviewed on 07/22/25. The clinical record included a POC dated 04/22/25, that included the SN services 1 times a week for 9 weeks. The records lacked the SN visit notes after 07/02/25. On 07/22/25 at 11:00 AM, during the interview with the Director of Nursing, it was stated the SN visits were conducted and the SN notes were not yet completed. 4. Pt. #7 was admitted to the Home Health services on 05/03/24 with the diagnosis of “Carcinoma in situ of rectosigmoid junction”. The clinical record was reviewed on 07/22/25. On 07/23/25, 11:00 AM, during the interview with the Director of Nursing, it was stated the patient refused the Home Health Care visits and wanted hospice care. The clinical notes were incomplete and lacked the documentation of patient’s request for hospice care. 5. The above findings were confirmed, during an interview with the Director of Nursing, Nursing Supervisor and QA RN on 07/23/25 between 8:58 AM and 11:30 AM. Findings include: 1. Pt. #1 was admitted for Home Health services on 05/15/25 with a diagnosis of, but not limited to Other Sequelae of Cerebral Infarction. The clinical record was reviewed on 07/22/25. The clinical record included the “Notice of Medicare Non-Coverage” form completed by the SN and signed by the patient’s caregiver on 05/15/25. The CMS form required the Agency to document the effective date that services will end. This section on the form was left blank. 2. Pt. #3 was admitted for Home Health services on 04/30/24 with a diagnosis of, but not limited to “Pulmonary Fibrosis, Unspecified. The clinical record was reviewed on 07/22/25. The clinical record included the undated “Notice of Medicare Non-Coverage” form completed by the SN and signed by the Pt. The CMS form lacked the effective date that services will end.

42 CFR 484.80(f)(3): Eligible training and competency evaluation organizations. Determination has been made that this Agency is not in compliance with the Conditions of Participation for: 42 CFR 484.70 Infection prevention and control and 484.75 Skilled professional services. Therefore, the Agency is precluded from conducting aide training and/or competency evaluations for 24 months effective 04/07/22. This applies even if the agency is not currently conducting aide training and/or competency evaluation. Abbreviations: x = times wk = week lb = pound # = number AM = morning E = Employee PRN = as needed SN = Skilled Nurse POC = Plan of care SOC = Start of care PsOC = Plans of Care RN = Registered Nurse PM = afternoon/evening HHA = Home Health Aide Pt./Pts. = Patient/Patients DON = Director of Nursing ROC = Resumption of Care MSW = Medical Social Worker ST = Speech Therapy/Therapist PT = Physical Therapy/Therapist ABN = Advance Beneficiary Notice COVID-19 = Coronavirus disease 2019 IADL's = Instrumental Activities of Daily Living

Patient's or legal representative's signature CFR(s): 484.50(a)(2) Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities. This ELEMENT is not met as evidenced by: A. Based on clinical record review, it was determined the Agency failed to ensure it obtained Pt./patient’s legal representative signature verifying receipt of their rights and responsibilities. This was found in 3 of 7 (Pts. #4, 5, and 7) clinical records reviewed. Findings include: 1. The following clinical records were reviewed beginning 4/5/22 at 1:30 PM to 4/6/22 at 9:30 AM: Pt. #4 SOC: 1/1/22. Pt. #5 SOC: 1/9/21. Pt. #7 SOC: 3/18//21. The records lacked documentation the Pts./Patients’ legal representative acknowledged in writing the receipt of a copy of their rights and responsibilities. 2. During interviews with the Administrator and DON on 4/6/22 at 1:00 PM and with the DON on 4/6/22 at 2:32 PM, it was confirmed that the above records lacked documentation the Pts./patient's legal representative acknowledged in writing the receipt of their rights and responsibilities at the SOC.

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: A. Based on a review of clinical records, Agency policy and staff interview, it was determined that the Agency failed to obtain informed consents for care and treatment, including the disciplines that will provide care and the frequency of visits. This was found in 3 of 7 clinical records reviewed. (Pts. #4, 5, and 7). Findings Include: 1. The following clinical records were reviewed beginning 4/5/22 at 1:30 PM to 4/6/22 at 9:30 AM: Pt. #4 SOC: 1/1/22. Pt. #5 SOC: 1/9/21. Pt. #7 SOC: 3/18//21. The records lacked documentation the above Pts./patient's legal representative consented to Agency care and services, the disciplines that will provide care and the frequency of visits at the SOC. 2. The Agency’s “Bill of Rights Statement” was reviewed on 4/6/22 at 11:00 AM. The statement required: “…The Patient has the right to…Participate in, be informed about, and consent or refuse in advance and during treatment, where appropriate, with respect to…The care to be furnished…The disciplines that will furnish the care; the frequency of visits…” 3. During interviews with the Administrator and DON on 4/6/22 at 1:00 PM and with the DON on 4/6/22 at 2:32 PM, it was confirmed that the above records lacked documentation the Pts./patient's legal representative consented to the disciplines that would be providing care, and the frequency of visits at the SOC.

Payment from federally funded programs CFR(s): 484.50(c)(7)(i, ii, iii, iv) Be advised, orally and in writing, of- (i) The extent to which payment for HHA services may be expected from Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (ii) The charges for services that may not be covered by Medicare, Medicaid, or any other federally-funded or federal aid program known to the HHA, (iii) The charges the individual may have to pay before care is initiated; and (iv) Any changes in the information provided in accordance with paragraph (c)(7) of this section when they occur. The HHA must advise the patient and representative (if any), of these changes as soon as possible, in advance of the next home health visit. The HHA must comply with the patient notice requirements at 42 CFR 411.408(d)(2) and 42 CFR 411.408(f). This ELEMENT is not met as evidenced by: A. Based on a review of clinical records, and staff interview, it was determined the Agency failed to ensure Pts. were advised of the extent of their financial liability for care, and/or services before care was initiated. This was found in 3 of 7 (Pts. #4, 5, and 7) clinical records reviewed. Findings include: 1. The following clinical records were reviewed beginning 4/5/22 at 1:30 PM to 4/6/22 at 9:30 AM: Pt. #4 SOC: 1/1/22. Pt. #5 SOC: 1/9/21. Pt. #7 SOC: 3/18//21. The records lacked documentation the Pts./patient legal representative were advised of their financial responsibility for care and services before care was initiated. 2. During interviews with the Administrator and DON on 4/6/22 at 1:00 PM, and with the DON on 4/6/22 at 2:32 PM, it was confirmed that the above records lacked documentation the Pts. were informed of their financial liability for care and services prior to the initiation of care.

RN performs assessment CFR(s): 484.55(a)(1) A registered nurse must conduct an initial assessment visit to determine the immediate care and support needs of the patient; and, for Medicare patients, to determine eligibility for the Medicare home health benefit, including homebound status. The initial assessment visit must be held either within 48 hours of referral, or within 48 hours of the patient's return home, or on the physician or allowed practitioner - ordered start of care date. This ELEMENT is not met as evidenced by: A. Based on a review of clinical records and staff interview, it was determined the Agency failed to ensure the initial assessment visit was done within 48 hours of the referral date. This was found in 2 of 7 (Pts. #1 and 5) clinical records reviewed. Findings include: 1. Pt. #1. SOC 2/2/21. Diagnoses: Functional Quadriplegia, Encounter for Attention to Gastrostomy and Encounter for Attention to Colostomy. The clinical record was reviewed on 4/6/22 at 9:00 AM. The record contained the SOC comprehensive assessment dated 2/2/21; and the Physicians “Clinical Encounter Summaries” form completed on 2/25/21, faxed to the Agency on “02/26/2021” requiring the SN to provide service. The SOC visit was conducted 24 days before the Agency received the referral to initiate care/service. No further referral/Physician order was present prior to the initial visit. 2. Pt. #5. SOC 1/9/21. Diagnoses: Other Pulmonary Embolism without Acute Cor Pulmonale and Hypertensive Heart Disease with Heart Failure. The clinical record was reviewed on 4/5/22 at 1:30 PM. The record contained the SOC comprehensive assessment dated 1/9/21; and the “Verbal consent… for Home Health Services” signed by the Physician on 1/5/21. The same record included documentation the “Verbal consent" was faxed to the Agency on “04/16/2021”. It cannot be determined whether the SOC visit was conducted with 48 hours of receipt of the referral. 3. During an interview with the DON on 4/6/22 at 2:32 PM, the DON stated the Agency lacked a Physician’s order to initiate service for Pt. #1, until 24 days after the SOC. The DON also stated the Agency received a verbal order to start service on Pt. #2, but could not recall the date the order was received, and the Agency lacked a verbal order to initiate service on Pt. #2. During the same interview on 4/6/22, the DON 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: A. Based on clinical record review and staff interview, it was determined the Agency failed to provide services as ordered by the Physician on the POC. This was found in 1 of 7 (Pt. 6) clinical records reviewed. Findings include: 1. Pt. #6. SOC: 9/3/21. Primary Diagnosis: Type 2 Diabetes Mellitus with Diabetic Polyneuropathy. The clinical record was reviewed on 4/5/22 at 2:25 PM. The record contained the POC effective 9/3/21 to 11/1/21, which included the Physician’s order: "HHA: 2wk9.” The record lacked documentation HHA services were ever provided to the Pt. following this order. The record also lacked documentation of a Physician’s order to discontinue HHA services. 2. During an interview with the Administrator and DON on 4/6/22 at 1:00 PM, the DON confirmed the above findings.

Plan of care must include the following CFR(s): 484.60(a)(2)(i-xvi) The individualized plan of care must include the following: (i) All pertinent diagnoses; (ii) The patient's mental, psychosocial, and cognitive status; (iii) The types of services, supplies, and equipment required; (iv) The frequency and duration of visits to be made; (v) Prognosis; (vi) Rehabilitation potential; (vii) Functional limitations; (viii) Activities permitted; (ix) Nutritional requirements; (x) All medications and treatments; (xi) Safety measures to protect against injury; (xii) A description of the patient's risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. (xiii) Patient and caregiver education and training to facilitate timely discharge; (xiv) Patient-specific interventions and education; measurable outcomes and goals identified by the HHA and the patient; (xv) Information related to any advanced directives; and (xvi) Any additional items the HHA or physician or allowed practitioner may choose to include. This ELEMENT is not met as evidenced by: A. Based on an interview during a home visit, review of clinical records and staff interview, it was determined the Agency failed to ensure the POC included necessary interventions and services provided by the staff, and only as ordered by the Physician. This was found in 2 of 7 (Pts. #1 and 6) clinical records reviewed. 2. Pt. #6. SOC: 9/3/21. Primary Diagnosis: Type 2 Diabetes Mellitus with Diabetic Polyneuropathy. The clinical record was reviewed on 4/5/22 at 2:25 PM. The record included the SN discharge summary, which documented the Pt. was discharged from Agency services on 12/1/22. The record also included ST visit notes, indicating the ST continued to provide service to the Pt. on 12/7/21, 12/13/21, and 12/20/21, after the Patient’s discharge from the Agency. 3. During an interview with the Administrator and DON on 4/6/22 at 1:00 PM, and with the DON on 4/6/22 at 2:32 PM, the DON confirmed the above findings, and stated all services are to be provided only as ordered by a Physician, and all Pt. services should cease after discharge from the Agency. Findings include: 1. Pt. #1. SOC 2/2/21. Diagnoses: Functional Quadriplegia, Encounter for Attention to Gastrostomy and Encounter for Attention to Colostomy. The clinical record was reviewed on 4/6/22 at 9:00 AM. The record contained the PsOC for the certification period of 1/28/22 to 3/28/22 and effective 3/29/22. Both PsOC lacked interventions pertaining to care and/or maintenance of the patient’s gastrostomy tube and colostomy. A home visit was conducted on 4/5/22 at 11:20 AM with Employee #1. During the home visit an interview was conducted with the patient’s caregiver that stated the “nurse checks the g-tube and the colostomy when she come, and sometimes change the dressing on the g-tube… when the nurse is not here I do it.

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 a review of clinical records and staff interview, it was determined the Agency failed to ensure immunization screening status was updated and documented. This was found in 4 of 7 (Pts. #5, 3, 4 and 7) clinical records reviewed. Findings include: 1. Pt. #5. SOC 1/9/21. Diagnoses: Other Pulmonary Embolism without Acute Cor Pulmonale and Hypertensive Heart Disease with Heart Failure. The clinical record was reviewed on 4/5/22 at 1:30 PM. The record contained the SOC comprehensive assessment form completed by the SN and dated 1/9/21. The assessment included the Pt. last received the Flu (Influenza) vaccine on “02/15/2019”. The record lacked documentation that staff screened the Pt. for Influenza vaccine in 2021, indicating whether the vaccine was administered, arranged or refused in 2021 and 2022. 2. Pt. #/3. SOC 2/12/20. Diagnoses: Huntington’s Disease, Dementia, Dysphagia, and Epilepsy. The clinical record was reviewed on 4/5/22 at 12:00 PM. The record included the SOC comprehensive assessment, dated 2/12/20, and the recertification assessment dated 3/29/20. These assessments included a section titled “Most Recent Immunizations.” “Pneumonia” and “Flu” were checked “No.” No further information was provided, such as when or if these immunizations were given, offered, or declined by the Pt./Caregiver. 3. Pt. #4 SOC: 1/1/22. Primary Diagnosis: Chronic Obstructive Pulmonary Disease with Acute Exacerbation. The clinical record was reviewed on 4/5/22 at 1:30 PM. The record contained the SOC comprehensive assessment dated 1-1-22, and the recertification assessment dated 2/28/20. These assessments included a section titled “Most Recent Immunizations.” “Flu” was checked “Yes, 3/21/19.” No further information was provided, such if the Pt./Caregiver was offered or declined an Influenza vaccine for the current flu season. 4. Pt. #7. SOC: 3/18/21. Primary Diagnosis: Essential (Primary) Hypertension. The clinical record was reviewed on 4/6/22 at 9:30 AM. The record included the SOC comprehensive assessment, dated 3/18/21. This assessment included a section titled “Most Recent Immunizations.” “Pneumonia” and “Flu” were checked “No.” No further information was provided, such as when or if these immunizations were given, offered, or declined by the Pt./Caregiver. 5. During an interview with the DON and the Administrator on 4/7/22 at 1:00 PM, and with the DON on 4/6/22 at 2:32 PM, the Director of Nursing confirmed the above findings. The DON stated the RN or PT (If the Pt. is to receive PT only services) should assess the Patient’s flu and pneumonia vaccine status during the SOC assessment, and upon each ROC assessment. The SN/PT should determine when the Pt. was last vaccinated, or if they would like to receive/decline these vaccines. If the Pt. requests to be vaccinated with the flu/pneumonia vaccine, the RN/PT would refer this information to the Patient’s Physician. This information should then be documented on the SOC/ROC comprehensive assessment. The DON stated the Agency does not have a specific policy regarding Influenza and Pneumococcal vaccinations.

Infection prevention and control CFR(s): 484.70 Condition of Participation: Infection prevention and control. The HHA must maintain and document an infection control program which has as its goal the prevention and control of infections and communicable diseases. This CONDITION is not met as evidenced by: A. Based on review of personnel files, the Agency's COVID-19 Vaccination binder and staff interview, it was determined the Agency failed to ensure all staff are fully vaccinated for COVID-19, policies and procedures were developed and initiated pertaining to the COVID-19 vaccination requirements for staff, providing direct Pt. care and/or services. This was found in 2 of 5 personnel files (Employees #2 and 4), and has the potential to affect all Pts. and staff of the Agency. 1. In 2 of 5 personnel files reviewed, the Agency lacked the employees COVID-19 vaccination status. The Agency failed to ensure policies and procedures were developed, and initiated pertaining to the COVID-19 vaccination requirements for staff, providing direct Pt. care and/or services (G687). The cumulative effect of these systemic practices resulted in the Agency’s inability to ensure the safety of Pts. and infection control practices of staff.

COVID-19 Vaccination of Home Health Agency staff CFR(s): 484.70 (d)-(d)(3)(i-x) § 484.70 Condition of Participation: Infection Prevention and Control. (d) Standard: COVID-19 Vaccination of Home Health Agency staff. The home health agency (HHA) must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine. (1) Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following HHA staff, who provide any care, treatment, or other services for the HHA and/or its patients: (i) HHA employees; (ii) Licensed practitioners; (iii) Students, trainees, and volunteers; and (iv) Individuals who provide care, treatment, or other services for the HHA and/or its patients, under contract or by other arrangement. (2) The policies and procedures of this section do not apply to the following HHA staff: (i) Staff who exclusively provide telehealth or telemedicine services outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section; and (ii) Staff who provide support services for the HHA that are performed exclusively outside of the settings where home health services are directly provided to patients and who do not have any direct contact with patients, families, and caregivers, and other staff specified in paragraph (d)(1) of this section. (3) The policies and procedures must include, at a minimum, the following components: (i) A process for ensuring all staff specified in paragraph (d)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the HHA and/or its patients; (ii) A process for ensuring that all staff specified in paragraph (d)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations; (iii) A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19; (iv) A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (d)(1) of this section; (v) A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC; (vi) A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law; (vii) A process for tracking and securely documenting information provided by those staff who have requested, and for whom the HHA has granted, an exemption from the staff COVID-19 vaccination requirements; (viii) A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws, and for further ensuring that such documentation contains (A) All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and (B) A statement by the authenticating practitioner recommending that the staff member be exempted from the HHA's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications; (ix) A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and (x) Contingency plans for staff who are not fully vaccinated for COVID-19. This STANDARD is not met as evidenced by: A. Based on review of personnel files, the Agency's staff COVID-19 Vaccination binder and staff interview, it was determined the Agency failed to ensure all staff are fully vaccinated for COVID-19, and that policies and procedures were developed, and initiated pertaining to the COVID-19 vaccination requirements for staff, providing direct Pt. care and/or services. This was found in 2 of 5 personnel files (Employees #2 and 4), and has the potential to affect all Pts. and staff of the Agency. 1. The following personnel files were reviewed on 4/6/22 at 10:15 AM and lacked any documentation of employees COVID-19 vaccination status: Employee #2. Date of hire 10/20/13. Employee #4. Date of hire 9/6/13. 2. The Agency's binder titled, "COVID-19 Vaccination" was reviewed on 4/6/22 at 12:20 PM. The binder lacked any documentation of the following employees COVId-19 vaccination status: Employee #2. Date of hire 10/20/13. Employee #4. Date of hire 9/6/13. The binder also lacked any policies and/or plan of action for securing: 100% compliance of all staff being fully vaccinated with the COVID-19 vaccine, temporary delay of the vaccine, development of additional precautions for staff not vaccinated, archiving information of staff not vaccinated and the reason, applicable exemptions for the vaccine, the procedure for requesting COVID-19 vaccine exemption, and the Agency's decision-making process of the exemption requests. The Agency lacked documentation of staff tracking and/or follow-up for unvaccinated staff. 3. During an interview with the Director of Nursing on 4/6/22 at 2:32 PM, the Director of Nursing confirmed the Agency failed to establish the required policies and procedures pertaining to the COVID-19 vaccination staff requirements for employees, providing direct Pt. care and/or services.

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: A. Based on observation and interview during a home visit, clinical record review. Agency policy review and staff interview, it was determined the Agency failed to provide skilled ST services as ordered by the Physician; notify the Physician of Pt./Caregiver refusal of care and requests, and notify the Physician that ordered MSW, ST, and hospice evaluation services were not provided or not provided in a timely manner. This has the potential to affect all Pts. receiving services Findings include: 1. In 1 of 7 records reviewed, the Agency failed to provide skilled ST services as ordered by the Physician (G710). 2. In 2 of 7 Pts., the Agency failed to reviewed for coordination of services (G718). The cumulative effects of these systemic practices resulted in the Agency's inability to provide care effective and ensure patients received the care and services of a skilled professionals as ordered.

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: A. Based on observation and interview during a home visit, and clinical record review, it was determined the Agency failed to provide skilled professional services as ordered by the Physician. This was found in 1 of 7 (Pt. #3) clinical records reviewed. Findings include: 1. Pt. #/3. SOC 2/12/20. Diagnoses: Huntington’s Disease, Dementia, Dysphagia, and Epilepsy. A home visit was conducted on 4/5/22 at 9:20 AM, along with E #4. During this home visit, Pt. #3 was observed lying in bed, emaciated, and non-verbal. E #4 stated Pt #3 is bedbound, needs to be fed, and has been having increasing difficulty swallowing and eating, and sometimes won’t even open his mouth. The record included the POC effective 2/1/22 to 4/1/22, which included the Physician’s order: “ST: Evaluate and treat” and the Physician's order "MSW to evaluate patient needs, possible placement for nursing home." The record lacked documentation the ST had ever seen Pt. #3 following this order, or that the Physician was notified the ST evaluation never occurred. 2. During an interview with the Administrator and DON on 4/6/22 at 1:00 PM, the DON confirmed the above findings, and stated a Physician’s order for an MSW or ST consult should be completed by the MSW or ST within 2 days. If there is any difficulty scheduling the evaluation with the Pt./Caregiver, the MSW or ST should write a communication note and notify the Physician. The DON confirmed the Pt. did not receive this service, and the Physician was not notified.

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: A. Based on observation and interview during a home visit, staff interview, clinical record review, and Agency policy, it was determined the Agency failed to notify the Physician of Pt./Caregiver refusal of care and requests, and notify the Physician ordered MSW, ST, and hospice evaluation services were not provided/ not provided in a timely manner. This was found in 2 of 5 (Pt. #3 and #4) clinical records reviewed, wherein multiple disciplines provided service. Findings include: 1. Pt. #/3. SOC 2/12/20. Diagnoses: Huntington’s Disease, Dementia, Dysphagia, and Epilepsy. A home visit was conducted on 4/5/22 at 9:20 AM, along with E #4. During this home visit, Pt. #3 was observed lying in bed, emaciated, and non-verbal. E #4 stated Pt #3 is bedbound, needs to be fed, and has been having increasing difficulty swallowing and eating, and sometimes won’t even open his mouth. Pt. #3’s clinical record was reviewed on 4/5/22 at 12:00 PM. The record included the 2/1/22 Physician’s order: "Speech Therapy to evaluate and Treat.” The record lacked documentation the Speech Therapist has ever seen Pt. #3 following this order, or that the Physician was notified the ST evaluation never occurred. The record also contained the 2/8/22 Physician’s order: “MSW to evaluate Patient needs, possible placement for nursing home.” The record lacked documentation the MSW had ever seen Pt. #3 following this order, or that the Physician was notified the MSW evaluation never occurred. The record also included the 3/17/22 Physician’s order: Home Hospice.” The record lacked documentation Pt. #3 has ever received a hospice evaluation following this order, or that the Physician was notified the hospice evaluation never occurred. The record also contained E#4’s SN visit note dated 3/24/22, which included: “…Pt. with increased difficulty swallowing and opening mouth, making feedings difficult due to choking/gagging. SN called Physician. SN spoke with Doctor’s Nurse explaining current situation. Physician is recommending hospice for Pt. due to advancement of disease. SN spoke with Caregivers regarding the recommendation for hospice. The Family/Caregivers are declining hospice at this time. They would like to have a g-tube placed.” The record lacked documentation E #4 notified Pt. #3’s Physician of Pt. #3’s Family/Caregivers’ decision. During a telephone interview with E #4 on 4/5/22 at 2:00 PM, E #4 confirmed she did not notify Pt. #3’s Physician of the Family/Caregivers’ decision. After the home visit on 4/5/22, an interview was conducted with the RN case manager who stated the caregiver is not a relative, authorized legal representative and/or guardian. The record also included E #4’s recertification assessment dated 3/29/22, which included the section “Vital Signs,” which included the Pt. was non-weight bearing. This assessment also included the section “Nutrition.” In this section, a reported weight loss of “20 lb. in 12 months” was noted, with the comments “Difficulty chewing/swallowing due to complications of the disease process…” There was no documentation the Pt. #3’s Physician was notified of this weight loss. 2. Pt. #4 SOC: 1/1/22. Primary Diagnosis: Chronic Obstructive Pulmonary Disease with Acute Exacerbation. The clinical record was reviewed on 4/5/22 at 1:30 PM. The record contained the 3/2/22 Physician’s order “MSW for Patient, is in need for Home Health Aide assistance with IADL’s due to marked mobility limitation.” The MSW evaluation was completed 3/31/22—29 days after the Physician’s order. The record lacked documentation the Physician was notified of the delay in the MSW evaluation. 3. The Agency policy titled “Monitoring Patient’s Response/Reporting to Physician” was reviewed on 4/6/22 at 12:30 PM. The policy required: “…Clinicians will monitor, document, and report the Patient’s response to care and treatment…The Patient’s Physician will be contacted on the same day when any of the following occur: Changes in the Patient’s condition…Changes that have occurred regarding diagnoses, prognosis, or treatment…The Nurse or Therapist will immediately notify the Clinical Supervisor or designee regarding the need for medical consultation and problems encountered…” 4. During an interview with the Administrator and DON on 4/6/22 at 1:00 PM, the DON confirmed the above findings, and stated SN’s should promptly notify the Physician if a Pt./Caregiver refuses care or requests additional care/services. An MSW or ST evaluation should be completed within 2 days of the Physician’s order. If this can’t be done, the MSW or ST should document this and notify the Physician.

Authentication CFR(s): 484.110(b) Standard: Authentication. All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry. This STANDARD is not met as evidenced by: A. Based on a review of clinical records, Agency policy and staff interview, it was determined the Agency failed to ensure that documentation entered into the clinical record was complete. This was found in 2 of 7 (Pts. #1 and 2) clinical records reviewed. Findings include: 1. Pt. #1. SOC 2/2/21. Diagnoses: Functional Quadriplegia, Encounter for Attention to Gastrostomy and Encounter for Attention to Colostomy. The clinical record was reviewed on 4/6/22 at 9:00 AM. The record contained the undated form titled: "Advance Beneficiary Notice of Non-coverage (ABN), signed by the patient’s authorized representative. The form required the Agency to enter the item or service that Medicare will not pay, reason for non-coverage and the estimated cost. The form also required the Pt. to choose 1 of 3 options which include: Option 1 - The Pt. receive the service or care and wait for a decision of Medicare, if Medicare does not pay, the Pt. is responsible for payment; Option 2 - Receive the service or care and do not bill Medicare, the Pt. is responsible for payment; Option 3 - Refuse the care or service. The form was left blank. The Agency failed to enter the required documentation indicated above, before the Pt. signed the form. 2. Pt. #2. SOC 5/29/21. Primary Diagnosis: Unspecified Peripheral Vascular Disease. The clinical record was reviewed on 4/5/22 at 3:00 PM. The record contained the undated form titled: "Advance Beneficiary Notice of Non-coverage (ABN), signed by the patient’s authorized representative. This form was left blank. The Agency failed to enter the required documentation, before the Pt. signed the form. 3. The Agency policy titled, “Record of Care, Treatment, and Services” was reviewed on 4/7/22 at 9:25 AM. The policy required: “…the agency will maintain an accurate, complete medical record for all patients who are assessed, care for, treated or served…” 4. During an interview with the DON on 4/6/22 at 2:32 PM, the DON confirmed the documents indicated above were incomplete, and entered into the patient’s clinical records.