Vintage Healthcare Services

“Establishment of the Emergency Program (EP) CFR(s): 484.102 §403.748, §416.54, §418.113, §441.184, §460.84, §482.15, §483.73, §483.475, §484.102, §485.68, §485.542, §485.625, §485.727, §485.920, §486.360, §491.12 The [facility, except for Transplant Programs] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility, except for Transplant Programs] must establish and maintain a [comprehensive] emergency preparedness program that meets the requirements of this section.* The emergency preparedness program must include, but not be limited to, the following elements: * (Unless otherwise indicated, the general use of the terms “facility” or “facilities” in this Appendix refers to all provider and suppliers addressed in this appendix. This is a generic moniker used in lieu of the specific provider or supplier noted in the regulations. For varying requirements, the specific regulation for that provider/supplier will be noted as well.) *[For hospitals at §482.15:] The hospital must comply with all applicable Federal, State, and local emergency preparedness requirements. The hospital must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: *[For CAHs at §485.625:] The CAH must comply with all applicable Federal, State, and local emergency preparedness requirements. The CAH must develop and maintain a comprehensive emergency preparedness program, utilizing an all-hazards approach. The emergency preparedness program must include, but not be limited to, the following elements: This Condition is not met as evidenced by: Based on staff interview and a review of the Agency’s policy and procedure binder, it was determined the Agency failed to review and update the Emergency Preparedness plan, complete an all hazards risk assessment, establish a communication plan, and conduct staff training and testing relative to the Emergency Preparedness plan. This has the potential to affect all Pts. who receive services from the Agency. Findings include: 1. The Agency failed to review and update the Emergency Preparedness plan (E0004). 2. The Agency failed to complete an all hazards risk assessment (E0006). 3. The Agency failed to establish a communication plan (E0029). 4. The Agency lacked documentation staff received training and testing of the Emergency Preparedness plan established by the Agency (E0036). The cumulative effect of these systemic practices resulted in the Agency’s inability to provide appropriate direction or supervision in the event of an emergency or disaster.”

“Organization and administration of services CFR(s): 484.105 Condition of participation: Organization and administration of services. The HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs. The HHA must assure that administrative and supervisory functions are not delegated to another agency or organization, and all services not furnished directly are monitored and controlled. The HHA must set forth, in writing, its organizational structure, including lines of authority, and services furnished. This Condition is not met as evidenced by: Based on observations, staff interviews and personnel file review, it was determined the Agency failed to ensure the Administrator was available for day-to-day operations, a clinical manager or designated alternate was available during operating hours, and a qualified alternate was available during the absence of the Administrator. This has the potential to affect all Pts. who receive services from the Agency. Findings include: 1. The Agency failed to ensure the Administrator maintained responsibility for day-to-day operations (G948). 2. The Agency failed to ensure the Director of Nursing or the designated alternate was available to direct Pt. care and oversee clinical matters (G950). 3. The Agency failed to ensure the Administrator appointed a qualified alternate to direct and organize the Agency’s operations and activities, in the absence of the Administrator (954). The cumulative effect of these systemic practices resulted in the Agency’s inability to provide appropriate clinical direction, and oversight of Pt. care and services.”

“Develop EP Plan, Review and Update Annually CFR(s): 484.102(a) §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: Based on staff interview and a review of the Agency’s policy and procedure binder, it was determined the Agency failed to review and update the Emergency Preparedness plan. This has the potential to affect all Pts. who receive services from the Agency. Findings include: 1. During an interview with the Administrator and Director of Nursing on 12/26/23 at 10:05 AM, and an interview with the Director of Nursing on 12/27/23 at 3:40 PM, requests were made to review the Agency’s Emergency Preparedness plan. On 12/27/23 at 3:45 PM, the Administrator and Director of Nursing presented the Agency’s undated policy and procedure manual/binder, the Director of Nursing stated the section titled, “Emergency Management (EM)” was the Agency’s Emergency Preparedness plan, this section lacked a date indicating when the policies were reviewed and updated. 2. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, both confirmed they failed to update the Emergency Preparedness plan.”

“Plan Based on All Hazards Risk Assessment CFR(s): 484.102(a)(1)-(2) §403.748(a)(1)-(2), §416.54(a)(1)-(2), §418.113(a)(1)-(2), §441.184(a)(1)-(2), §460.84(a)(1)-(2), §482.15(a)(1)-(2), §483.73(a)(1)-(2), §483.475(a)(1)-(2), §484.102(a)(1)-(2), §485.68(a)(1)-(2), §485.542(a)(1)-(2), §485.625(a)(1)-(2), §485.727(a)(1)-(2), §485.920(a)(1)-(2), §486.360(a)(1)-(2), §491.12(a)(1)-(2), §494.62(a)(1)-(2) [(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.* (2) Include strategies for addressing emergency events identified by the risk assessment. * [For Hospices at §418.113(a):] Emergency Plan. The Hospice must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach. (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice’s ability to provide care. *[For LTC facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents. (2) Include strategies for addressing emergency events identified by the risk assessment. *[For ICF/IIDs at §483.475(a):] Emergency Plan. The ICF/IID must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following: (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients. (2) Include strategies for addressing emergency events identified by the risk assessment. This Standard is not met as evidenced by: Based on staff interview and review of the Agency’s policy and procedure binder, it was determined the Agency failed to complete an all hazards risk assessment. This has the potential to affect all Pts. who receive services from the Agency. Findings include: 1. During an interview with the Administrator and Director of Nursing on 12/27/23 at 3:45 PM, the Director of Nursing presented the Agency’s policy and procedure manual/binder, the Director of Nursing stated the section titled, “Emergency Management (EM)” was the Agency’s Emergency Preparedness plan, this section included multiple templates titled, “Hazard Vulnerability Analysis (HVA): Agency (Facility-Based), Annual Evaluation of Hazard vulnerability Analysis (HVA): Agency (Facility-Based), Annual Evaluation of Hazard Vulnerability Analysis (HVA): Community-Based.” All the templates were left blank, the Agency failed to complete a facility-based and community-based hazard risk vulnerability assessment. 2. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, both confirmed the above findings.”

“Development of Communication Plan CFR(s): 484.102(c) §403.748(c), §416.54(c), §418.113(c), §441.184(c), §460.84(c), §482.15(c), §483.73(c), §483.475(c), §484.102(c), §485.68(c), §485.542(c), §485.625(c), §485.727(c), §485.920(c), §486.360(c), §491.12(c), §494.62(c). (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]. This Standard is not met as evidenced by: Based on staff interview and a review of the Agency’s policy and procedure binder, it was determined the Agency failed to establish an Emergency Preparedness communication plan. This has the potential to affect all Pts. who receive services from the Agency. Findings include: 1. During an interview with the Administrator and Director of Nursing on 12/26/23 at 8:53 AM, and the Director of Nursing on 12/27/23 at 3:40 PM, requests were made to review the Agency’s Emergency Preparedness plan. On 12/27/23 at 3:45 PM, the Director of Nursing identified the Agency’s policy and procedure manual/binder with the section titled, “Emergency Management (EM)” was the Agency’s Emergency Preparedness plan. The documents presented and reviewed included policies, and blank templates for creating a communication plan. As of 12/27/23, the Agency failed to establish an Emergency Preparedness communication plan. 2. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, both confirmed the Agency has Emergency Preparedness policies, and failed to establish a communication plan.”

“EP Training and Testing CFR(s): 484.102(d) §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: Based on staff interview and a review of the Agency’s policy and procedure binder, it was determined the Agency failed to conduct staff training and testing relative to the Agency’s Emergency Preparedness plan. This has the potential to affect all Pts. who receive services from the Agency. Findings include: 1. During an interview on 12/27/23 at 3:45 PM with the Administrator and Director of Nursing, the Agency’s policy and procedure manual/binder was presented. The Director of Nursing stated the section titled, “Emergency Management (EM)” was the Agency’s Emergency Preparedness plan. These documents were reviewed and consisted of Emergency Preparedness policies. As of 12/27/23, the Agency lacked documentation that staff received training and testing pertaining to the Emergency Preparedness plan established by the Agency. 2. The Agency’s policy and procedure binder was reviewed on 12/27/23, and included a section titled “Emergency Management (EM)” which contained an untitled policy that included, “...Exercises will review and confirm: Staff communication procedures and content. Assigned staff roles related to essential response functions. How Agency will communicate with patients during an emergency...Business continuity and recovery strategies for restoring Agency’s capabilities to provide care after an emergency... Analyze the Agency’s response to and maintain documentation of all drills, tabletop exercises, and emergency events...” The policy lacked documentation on how often testing of the emergency preparedness plan would be conducted. 3. The Agency’s policy and procedure binder was reviewed on 12/27/23 and included the section, “Emergency Management (EM)” which contained a form titled, “Employee Training: Emergency Operations Plan (EOP).” The form required the instructor to document whether the training was an initial training or Biennial training, employee’s name and date. The agency lacked completed EOP training forms for employees. 4. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, both confirmed the Agency lacked documentation of training and testing on the Emergency Preparedness Plan as per Agency policy.”

“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 clinical records review and staff interview, it was determined that for 3 of 7 (Pts. #2, 4 and 5) clinical records reviewed, the agency failed to ensure the PsOC were signed by the physician. Findings include: 1. Pt. #2 was admitted to Home Health Services on 11/1/23 with a diagnosis of, “Athscl Heart Disease of Native Coronary Artery.” The clinical record was reviewed on 12/27/23 and included a POC dated 11/1/23. The POC lacked the physicians signature. 2. Pt. #4 was admitted to Home Health Services on 11/18/23 with a diagnosis of, “Weakness.” The clinical record was reviewed on 12/27/23 and included a POC dated 11/18/23. The POC lacked the physician’s signature. 3. Pt. #5 was admitted to Home Health Services on 11/14/23 with a diagnosis of, “Fistula of Intestine.” The clinical record was reviewed on 12/27/23 and included a POC dated 11/14/23. The POC lacked the physician’s signature. 4. During an interview with the Director of Nursing on 12/27/23 at 3:00 PM, she stated the Agency’s practice is to have the physician’s sign the PsOC within 30 days. During the same interview, the above findings were confirmed.”

“Conformance with physician orders CFR(s): 484.60(b) Standard: Conformance with physician or allowed practitioner orders. This Standard is not met as evidenced by: Based on a review of clinical records, interview during a home visit, and staff interview, it was determined that for 3 of 7 (Pts. #3, 2 and 5) clinical records reviewed, the Agency failed to ensure staff provided service/treatment as ordered by the Physician and indicated in the PsOC. 2.Patient #2, was admitted to the Home Health Services on 11/01/23 with the Diagnoses of “Athscl Heart Disease of Native Coronary Artery” and Type 2 Diabetes Mellitus with Diabetic Neuropathy. The clinical record was reviewed on 12/27/23. The POC orders dated 11/01/23 required the SN to assess the weight and blood glucose. The SN failed to assess the weekly weights and blood glucose for the entire certification period 11/01/23 thru 12/28/23. 3. Patient #5, was admitted to the Home Health Services on 11/14/23 with the Diagnosis of Fistula of Intestine. The clinical record was reviewed on 12/27/23. The Plan of care Physician orders dated 11/14/23 required assessing pain. The SN failed to conducted a complete pain assessment (no rating documented) from 11/16/23 thru 12/01/23. 4. The findings were confirmed during the interview with the Administrator and Director of Nursing on 12/28/23 between 9:10 AM and 9:55 AM. Findings include: 1. The clinical record of Pt. #3 with diagnoses of Epilepsy, Unspecified, Not Intractable, without Status; Stage 4 (Severe) Chronic Kidney Disease and Dependence on Renal Dialysis was reviewed on 12/27/23. The record contained the POC effective 11/9/23 requiring, “OT for eval and treatment 2wk4 (8 visits) for the episode starting 11/09/2023 to 01/07/2024”. As of 12/27/23, the record lacked documentation the OT provided any service during the certification period effective 11/9/23. During a home visit on 12/27/23 with the Director of Nursing, an interview was conducted with Pt. #1 and the Power of Attorney, both requested OT services, the Director of Nursing responded “...you can call your doctor for an order, or I can call for you to get OT started again.” The Agency failed to provide OT services ordered on the POC effective 11/9/23. The POC effective 11/9/23 required the Home Health Aide to provide service “ADLs 3w9”. The “Aide Care Plan” completed by the RN and dated 9/10/23 required the Home Health Aide to provide a bed bath, personal care, shampoo hair, skin care, oral care, assist with elimination and ambulation, medication reminder and range of motion exercises “every visit”. The “Aide Weekly Note” dated 11/29/23 and 12/1/23 lacked documentation the Home Health Aide provided any of the above tasks.”

“A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This Element is not met as evidenced by: Based on a review of clinical records, observation and interview during a home visit, Agency policy and staff interview, it was determined that for 1 of 7 (Pt. #3) clinical records reviewed, the Agency failed to ensure medications were reconciled with the physicians. 1. Patient #3 was admitted to home health services on 9/10/23 with a diagnosis of Epilepsy, Unspecified. The clinical record was reviewed on 12/27/23. The record contained the recertification comprehensive assessment completed by the RN dated, 11/7/23. The assessment documented Pt. #3’s medication as: Cinacalcet 30 mg 1 tab p.o. daily, Clonidine 0.1 mg patch, Divalproex 500 mg EC 2 tabs morning and HS, Divalproex 500 mg EC 1 tab p.o. after dialysis, Levetiracetam250 mg 1/2 tab p.o. after dialysis, Lisinopril 40 mg 1 tab p.o. daily, Metoprolol Succinate 50 mg 1 tab p.o. daily, Sevelamer Carbonate 800 mg 2 tabs p.o. 4 times a day. During a home visit conducted with the Director of Nursing on 12/27/23 at 12:15 PM, the patient’s medications were observed and consisted of: Cinacalcet 30 mg tablets and Divalproex 500 mg tablets, no other medications were present. An interview was conducted with the Pt. and the patient’s Power of Attorney at 12:25 PM. The Power of Attorney stated, Pt. #3 had been “taking only the Cinacalcet and Divalproex and was out of the other medications for a long time... since the nurse was out in November.” The record lacked documentation the Medication had been reconciled after 11/7/23. 2. The Agency policy titled, “Medication Reconciliation” was reviewed on 12/28/23 and contained, “The Agency will reconcile patient’s medications at time of admission and on an ongoing basis...” 3. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, the Director of Nursing confirmed the above findings and stated the physicians will be contacted to reconcile the patient’s medications.”

“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 for 1 of 7 (Pt. #2) clinical records reviewed, the Agency failed to ensure the POC included all necessary Pt. information. Findings include: 1. Pt. #2 was admitted to the Home Health Services on 11/01/23 with the diagnosis of “Athscl Heart Disease of Native Coronary Artery.” The clinical record was reviewed on 12/27/23. The POC orders dated 11/1/23 lacked documentation of Nutritional requirements, Safety Measures, Allergies, DME and Supplies. 2. The findings were confirmed during an interview with the Director of Nursing on 12/27/23 between 2:00 PM and 3:00 PM.”

“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, it was determined that for 2 of 7 (Pts. #6 and 7) clinical records reviewed, the Agency failed to assess patients’ Influenza and/or Pneumococcal vaccine status at the SOC, as required by the Agency. Findings include: 1. Pt. #6 was admitted to the Home Health Services on 09/06/23 with the diagnosis of Human Immunodeficiency Virus (HIV) Disease. The clinical record was reviewed on 12/27/23 and contained the SOC comprehensive assessment form completed by the RN and dated 09/06/23. The form contained a section titled, “Immunizations Influenza... Pneumonia...”, these sections were left blank. The record lacked the Agency’s form “Influenza Vaccination Verification, Pneumonia Vaccination Verification...” 2. Pt. #7 was admitted to the Home Health Services on 06/21/23 with the diagnosis of Condition of the Puerperium, Unspecified. The clinical record was reviewed on 12/27/23 and contained the SOC comprehensive assessment form completed by the RN and dated 06/21/23, the form contained a section titled “Immunizations Influenza... Pneumonia...”, these sections were left blank. The Agency’s form titled “Influenza Vaccination Verification, Pneumonia Vaccination Verification...” was left blank regarding an inquiry for the need or refusal of the Influenza and Pneumonia vaccines. 3. During an interview with the Director of Nursing on 12/26/23, the Director stated, “During the SOC, the nurse assesses the patient’s Influenza and Pneumococcal Pneumonia vaccine status... There is a stand-alone form that we use, and it’s kept in the clinical record.” 4. During an interview with the Administrator and Director of Nursing on 12/27/23 at 11:00 AM and 12/28/23 at 9:03 AM, the Director confirmed the patients’ vaccine status was not assessed at the SOC.”

“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 clinical record review and staff interview, it was determined that for 1 of 1 (Pt. #3) clinical record reviewed, wherein the Pt. received Home Health Aide services, the Agency failed to ensure the Home Health Aide followed the Home Health Aide Care Plan. Findings include: 1. Pt. #3 was admitted to Home Health Services on 9/10/23 with a diagnosis of Epilepsy, Unspecified. The clinical record was reviewed on 12/27/23. The record contained the POC effective 11/09/23 requiring the Home Health Aide to provide service “ADLs 3w9”. The “Aide Care Plan” completed by the RN and dated 9/10/23 required the Home Health Aide to provide a bed bath, personal care, shampoo hair, skin care, oral care, assist with elimination and ambulation, medication reminder and range of motion exercises “every visit.” The “Aide Weekly Note” dated 11/29/23 and 12/01/23 lacked documentation the Home Health Aide provided any Pt. care. 2. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, the Director confirmed the record lacked documentation the Home Health Aide provided care as indicated on the Aide Care Plan.”

“Onsite supervisory visit every 14 days CFR(s): 484.80(h)(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 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 §484.80(g), must make an onsite visit to the patient’s home no less frequently than every 14 days. The home health aide does not have to be present during this visit. This Element is not met as evidenced by: Based on a review of clinical records and staff interview, it was determined that for 1 of 1 (Pt. #3) clinical record reviewed wherein the Pt. received Home Health Aide services, the Agency failed to ensure the RN conducted onsite Aide supervision every 14 days. Findings include: 1. Pt. #3 was admitted to home health services on 9/10/23 with a diagnosis of Epilepsy, Unspecified. The clinical record was reviewed on 12/27/23 and contained the Home Health Aide visit notes for services provided on 11/10/23; then 3 times a week during the week of 11/12/23 to 11/18/23, 12/3/23 to 12/9/23, 12/20/23 to 12/16/23, and 12/17/23 to 12/23/23. The record lacked documentation the RN supervised the Home Health Aide after 11/7/23. 2. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, the Director confirmed the record lacked documentation the RN conducted onsite Aide supervision every 14 days.”

“Responsible for all day-to-day operations CFR(s): 484.105(b)(1)(ii) (ii) Be responsible for all day-to-day operations of the HHA; This Element is not met as evidenced by: Based on observation and staff interview, it was determined the Agency failed to ensure the Administrator maintained responsibility for day-to-day operations of the Agency. This has the potential to affect all Pts. who receive services from the Agency. Findings include: 1.On 12/26/23 at 9:00 AM, it was observed that the Administrator and Clinical Manager were not available to assist with the survey. A sign was observed that included the operating hours as 8:30 AM until 5:00 PM, Monday through Friday. It was observed the Agency’s office was staffed by a Receptionist and the Biller, who could not assist with the survey, as requested. 2. On 12/26/23 at 10:20 AM, the personnel files were requested for review. The Agency was not able to present the personnel files on 12/26/23. 3. On 12/26/23 at 10:20 AM, the Clinical records were requested for review. The Agency was not able to present the clinical records on 12/26/23. 4. On 12/26/23, a home visit schedule was requested. The Agency was not able to present the home visit schedule on 12/26/23. 5. The Administrator failed to ensure Therapy Services were provided as per physician’s orders for all patients. 6. The Administrator failed to ensure all PsOC were reviewed and signed by the physician in a timely manner. 7. The above findings were confirmed on 12/26/23 at 10:30 AM, during a telephone interview with the Director of Nursing, and on 12/28/23 at 10:30 AM with the Administrator and Director of Nursing.”

“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: Based on observation, staff interview and policy review, it was determined the Administrator failed to ensure a clinical manager or designated Alternate Clinical Manager was available during the Agency’s operational hours. This has the potential to affect all Pts. served by the Agency. Findings include: 1. Upon entering the Agency on 12/26/23 at 8:50 AM, signage was observed, in the lobby, that included the Agency’s operating hours as Monday through Friday, 8:30 AM to 5:00 PM. The Agency’s receptionist stated, the Administrator and the Director of Nursing/Clinical Manager were not available. A request was made to speak with the Administrator. On 12/26/23 at 8:53 AM, the Administrator and Director of Nursing were contacted via telephone. The Administrator stated both Administrator and Director of Nursing were out-of-town, and will not return until Thursday, 12/28/23. The Administrator stated the only person onsite was the receptionist, but this person had no access to Agency records and/or documents. As of 12/26/23, the Agency lacked a Clinical Manager available during the operating hours of the agency to oversee clinical services, review and provide Agency documents and initiate the survey. 2. On 12/26/23 at 8:53 AM, a telephone interview was conducted with the Director of Nursing. She stated, “the Agency currently has 15 to 20 active patients, and that staff are providing Pt. care and services,” on 12/26/23. “If a patient has a question, concern or an emergency, the nurse will call me if there is an emergency, when I return, I will handle it... If it’s an emergency that need immediate attention, the nurse will call a family member... or 911.” The Clinical Manager stated no one was available to start the survey, and no one will be available until Thursday, 12/28/23 at 9:00 AM.” During this interview, it was confirmed the Agency lacked a Director of Nursing/Clinical Manager and/or an alternate for the Director of Nursing to direct Pt. care and oversee clinical matters. 3. On 12/27/23, the Director of Nursing presented a letter designating Employee #12 as the designated alternate for the Director of Nursing. Employee #12 was not available or present during the survey, 12/26/23 through 12/28/23. 4. The Agency policy titled, “Supervision of Staff” was reviewed on 12/28/23 and included: “All therapeutic services furnished are under the supervision and direction of a physician or a registered nurse...” 5. During an interview with the Administrator and Director of Nursing on 12/26/23 at 10:30 AM, and 12/28/23 at 9:03 AM, both confirmed the Director of Nursing and alternate was not available to oversee clinical services or assist with initiating the Agency’s survey on 12/26/23.”

“Ensures qualified pre-designated person CFR(s): 484.105(b)(2) When the administrator is not available, a qualified, pre-designated person, who is authorized in writing by the administrator and the governing body, assumes the same responsibilities and obligations as the administrator. The pre-designated person may be the clinical manager as described in paragraph (c) of this section. This Element is not met as evidenced by: Based on staff interview, observation and personnel file review, it was determined the Agency failed to ensure the Administrator designated a qualified alternate to be available during his absence. This has the potential to affect all Pts. served by the Agency. Findings include: 1. Upon entering the Agency on 12/26/23 at 8:50 AM, the Agency’s receptionist stated the Administrator was not available. A request was made to speak with the Administrator. On 12/26/23 at 8:53 AM, the Administrator was available via telephone. He stated he was out-of-town and will not return until Thursday, 12/28/23. The Administrator stated his designated alternate was the Agency’s Biller, but this person did not have access to Agency records and/or documents. As of 12/26/23, the Agency lacked an Alternate for the Administrator to direct and organize the Agency’s operations/activities in the absence of the Administrator. 2. On 12/27/2023 a statement of designation for the Alternate Administrator was requested. The Director of Nursing provided a designation statement, signed by the Agency’s Biller designating the Biller as the Alternate Administrator. The letter lacked the date of designation. 3. On 12/28/23 an interview was conducted with the Biller, the Agency’s designated alternate for the Administrator, she stated she is not a Physician or RN, her work background consisted of working in “Information Technology” at an insurance company and prior to that worked in “customer care.” She stated she did not have any health care experience prior to employment with this Agency on 06/15/13. The personnel file was reviewed on 12/28/23 and confirmed the above information. As of 12/28/23, the Biller lacked qualifications for designation of Alternate Administrator. 4. During interviews with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, both confirmed the above findings.”

“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 clinical records review, policy review and staff interview, it was determined that for 2 of 7 (Pts. #1 and 5) clinical records reviewed, the Agency failed to ensure clinical records included all assessments and clinical notes. Findings include: 1. Pt. #1 was admitted to Home Health Services on 11/07/23 with the diagnosis of Low Back Pain Unspecified. The clinical record was reviewed on 12/27/23. The clinical record included a POC dated 11/07/23 that ordered Occupational Therapy Services. As of 12/27/23, the clinical record lacked documentation of the OT evaluation and OT plan of care. 2. Pt. #5 was admitted to Home Health Services on 11/14/23 with a diagnosis of Fistula of Intestine. The clinical record was reviewed on 12/27/23. The clinical record included a POC dated 11/14/23 with orders for the SN frequency of 3 times a week for 9 weeks. The clinical record lacked documentation of SN visit notes after 12/06/23. 3. On 12/27/23 at 2:00 PM, during the interview with the Director of Nursing it was stated the staff notes were done but need to be filed into the record. 4. The Agency’s policy titled “Timely Submission of Patient Documentation” was reviewed on 12/27/23 at 2:00 PM. The policy required “..PROCEDURE …2. Itineraries, with all visit reports attached, must be submitted the next scheduled work day, not exceeding three (3) business days…” 5. The findings were confirmed during the interview with the Director of Nursing on 12/27/23 between 2:00 PM and 3:00 PM.”

“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 record review and staff interview, it was determined that for 1 of 2 (Pt. #7) closed/discharged records reviewed, the Agency failed to ensure staff completed a summary at discharge. Findings include: 1. The closed clinical record of Pt. #7 with a SOC date of 6/21/23 and diagnosis of Complication of the Purperium, Unspecified was reviewed on 12/27/23. The record contained documentation the SN provided services from 6/21/23 to 7/27/23. The discharge comprehensive assessment was completed by the SN and dated 7/23/23. The record contained a blank form titled, “Discharge Summary.” As of 12/27/23, the record lacked documentation the SN completed a discharge summary. 2. During an interview with the Administrator and Director of Nursing on 12/28/23 at 9:03 AM, the Director of Nursing confirmed the SN failed to complete a discharge summary.”