Every finding on record at Barnabas Health Care Services, Inc

On 3/10/25, and 3/11/25, a survey for compliance with Appendix Z, Emergency Preparedness requirements, §484.102 was conducted during a standard recertification survey. The agency was NOT IN compliance.

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 interview and document review, the facility failed to conduct testing of the emergency preparedness plan at least every two years. This had the potential to affect all patients. During review of the facility emergency preparedness plan, the facility provided evidence of one severe weather tabletop drill completed on 2/25/23. The facility emergency preparedness plan lacked evidence of any other testing since. When interviewed on 3/10/25 at 3:37 p.m., the administrator confirmed a facility emergency preparedness drill or exercise had not been completed since 2/25/23. The facility policy Emergency Preparedness plan dated 2023, identified the facility emergency plan must include testing and drills.

On 3/10/25 and 3/11/25, a recertification survey was conducted. This resulted in a partial extended survey at Barnabas Health Care Services. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. The cumulative effects of these findings resulted in the Home Health Agency’s inability to ensure the provision of quality of care. Unduplicated census previous 12 months: 36 Total home visits conducted: 03 List Parent Location visited, including the addresses as verified while on site: Barnabas Health Care Services 521 Charles St. Ste 202 Brainerd, MN 56401 Branch offices for this agency: None Hours of Operation: 9:00 a.m. to 5:00 p.m. Total number of records reviewed: 09

Investigate complaints made by patient CFR(s): 484.50(e)(1)(i) The HHA must— (i) Investigate complaints made by a patient, the patient's representative (if any), and the patient's caregivers and family, including, but not limited to, the following topics: (A) Treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately; (B) Mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the HHA. This ELEMENT is not met as evidenced by: Based on interview and document review, the facility failed to investigate a complaint related to medication set up for 1 of 2 patients (P3) reviewed who received skilled services from the agency. P2's plan of care (POC) with a certification period of 2/8/25 to 4/8/25, identified a (SOC) date of 10/17/19. Diagnoses included unspecified systolic (congestive) heart failure (a serious condition that occurs when the left ventricle can't pump blood efficiently), chronic obstructive pulmonary disease (COPD) (a common, preventable and treatable disease that is characterized by persistent respiratory symptoms like progressive breathlessness and cough), and type 2 diabetes with unspecified complications. P2 required skilled nursing visits (SNV) once every other week to help manage P2's diabetes, COPD, medications, coordination with medical providers and medication set-up. P2's VA Medication Reconciliation dated 2/13/25, identified the following: 1/24/25, isosorbide dinitrate (a nitrate that dilates (widens) blood vessels and prevent angina attacks (Chest discomfort or shortness of breath caused when heart muscles receive insufficient oxygen-rich blood) 10 milligram (mg) tablets. Take one tablet by mouth every morning, take one tablet by mouth at noon and take one tablet by mouth before bedtime. 1/4/25, ferrous sulfate 325 mg tablets. Take one tablet by mouth daily for iron supplement. RX expiration date 1/27/25. During a home visit on 3/11/25 at 1:00 p.m., P2’ s medications were reviewed with registered nurse (RN)-A while RN-A set up P2’s medications into a plastic rectangle four-line medicine organizer and two plastic rectangle single line medicine organizers. The POC for the certification period 2/8/25 to 4/8/25 and the medication administration log RN-A referred to included isosorbide dinitrate 10 mg tablets. The directions were to take one tablet by mouth three times a day. RN-A was observed to not set up one isosorbide dinitrate tablet into the medicine organizers. Additionally, P2 had a bottle of ferrous sulfate 325 mg tablets. RN-A stated ferrous sulfate was not on P2’s POC or medication administration log and she would need to contact P2’s provider. Upon review of P2's VA Medication Reconciliation, RN-A stated the ferrous sulfate order was missed on P2's POC. During an interview with P2 on 3/11/25 at 2:14 p.m., P2 stated RN-A was a “nice lady” but P2 did have concerns that his medication wasn't set up correctly. It's supposed to be a 1-hour visit and sometimes it's 3 hours. RN-A “just doesn't seem to get it.” P2 stated he always had to count each pill to make sure it's the right number before taking. For the last 3 medication set ups, not including 3/11/25, the medication set up had been wrong. It should be eight pills in the morning and nine in the evening (after 3/11/25, 9 pills in the morning and 9 pills in the evening, but sometimes there were 7 pills and/or 12 pills. The prior medication set up, P2’s tamsulosin was put in for twice a day when it was supposed to be once a day. P2 knew it was tamsulosin by color and because it was a capsule. P2 stated he would not be able to distinguish the other medication. P2 stated “you can't trust” the medication set up. P2 stated he had called the agency office three times with concerns. P2 stated he was told the agency would find another nurse but that had not happened. During an interview on 3/11/25 at 2:39 p.m., the administrator stated P2 had called with concerns but the administrator believed it was more of a “getting along” situation. The administrator didn’t make any official documentation but reassured P2 and encouraged P2 to get to know RN-A. The administrator stated she was unaware RN-A was performing medication errors. During a phone interview on 3/11/25 at 4:01 p.m., the director of nursing (DON) stated patient complaints should be documented and investigated to ensure patient safety. A review RN-A’s employee file did not reflect any documentation related to medication errors and lacked any additional education, counseling or education regarding medication set up. The agency policy Handling of Clients Complaints review 3/2024, identified the agency would identify and continually improve the care and services provided to clients by timely, appropriately and effectively handling of complaints received from clients or client's representative, and/or family members. Complaints are client issues that can be resolved promptly or within 24 hours. Complaints typically involve minor issues such as poor communication with the staff or lack of courtesy from the staff. The following six steps shall be taken when handling client complaints: Listen to the client. This is the most important step when dealing with an unhappy client. Acknowledge the client's feelings. Empathy is key when it comes to successfully handling client complaints. Keep in mind that this person is a client, he or she may not feel well or just received an unfortunate diagnosis. Demonstrate to client that his or her feelings are valid. Ask questions. Obtain as much information as possible. Read back documentation to be sure all information is correct. This will best help to figure out how to handle the complaint and avoid any issues that could arise in the future. Explain and take action. Inform the client that his/her complaint is being taken seriously and suggest solutions. Explain that it will be reviewed and discussed among the management. Inform the client that the supervisor or administrator will follow up with them after the complaints have been thoroughly investigated. Provide a time frame as to when the client can expect communication regarding the issue. When the client can expect communication regarding the issue. Conclude. Thank clients for taking the time to report the matter to the Barnabas' attention. Ensure the client understands that his/her satisfaction is Barnabas number one priority. Document complaints. Formally document any client complaints, whether big or small. It is important to follow the protocol for handling issues internally. Follow-up with the client, be sure to do so in a timely manner.

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview, and document review, the agency failed to ensure medications were reconciled and/or set up as ordered for 4 of 7 clients (P2, P5, P1, P3) whose medications were reviewed during home visits or record review. P3's plan of care (POC) 3/4/25 to 5/2/25, identified a start of care (SOC) 7/23/21, with diagnoses which included diabetes, kidney disease and malignant neoplasm of the kidney. Services included skilled nurse visits (SNV) every other week for nine weeks for medication setup, assist to manage care, maintain safety and work on goals for health maintenance. P3 was prescribed a number of medications which included Lantus insulin 20 units subcutaneously (SQ) in the morning and 25 units SQ in the evening. Review of P3's Veterans Administration Health Care Services Medication List for Review Summary dated 3/10/25, identified an order for Lantus insulin 10 units SQ every morning and 15 units every evening, with a start date 2/25/25. P3's Patient Medication List for certification period 3/4/25 to 5/2/25, listed a number of medications with route, does and frequency, which included Lantus insulin, give 20 units SQ every morning and 25 units SQ every evening with start date 1/4/24. During a home visit on 3/11/25, at 11:00 a.m. P3 stated he administered his insulin SQ, using an insulin pen and his current dose was to take 10 units in the morning and 15 units in the evening. P3 stated he had been taking that dose for a couple weeks. When interviewed on 3/11/25, at 3:30 p.m. registered nurse (RN)-A stated she reviewed all the medications a patient had when a recertification visit was completed. If a patient reported a medication change in between recertification visits, she wrote a physician's verbal order to cover it and then updated the medication list. RN-A had not caught the change in P3's insulin dosing and she had just completed his recertification visit. It should have been updated on his most recent POC. RN-A stated it was important to have the correct medications on the POC because that was signed by the primary physician and the agency, as well as the patient, were supposed to follow physician orders. The agency policy Medication Management dated March 2024, identified nursing staff were to evaluate client's medications, including over the counter medications upon admission. Nurses were to monitor and reassess client's medications at every visit for skilled clients and as needed. The medication profile would be updated for dose changes, frequency change, direction change, route change, medication addition or deletion, new allergy, physician change, and lab order changes. Nurses were to review and compare the medications listed on the POC to the medication bottles in the home and ask if there had been any physician visits since last nurse visit. If there had been a physician visit and the client related a medication was discontinued, or new medication added, the nurse would contact the physician and obtain the new medication orders. Once orders were received, the nurse would update the POC. The medication profile will be updated for dose changes, frequency change, direction change, route change, medication addition or deletion, new allergy, physician change, lab order changes. The changes will be added to the medications. P1's plan of care (POC) dated 2/20/25 to 4/20/25, identified a start of care (SOC) 11/3/22. Diagnoses included a history of cerebral infarction (stroke), hypertension and gout. Services included skilled nursing visits (SNV) monthly to monitor co-morbidities, manage and set-up medications for the month and to order medications. P1's Veteran's Administration (VA) Health Care Services Medication List for Review Summary dated 2/19/25, identified an order for calcium polycarbophil 625 milligrams (mg) one tablet by mouth two times a day with a start date of 12/5/24. P1's patient medication list for certification period of 2/20/25 to 4/20/25 listed his calcium polycarbophil order as 625 mg one to two times a day. When interviewed on 3/10/25 at 2:25 p.m., registered nurse (RN)-A and the administrator acknowledged the calcium polycarbophil order discrepancy and stated the order P1's POC should be as listed on his VA medication list as twice a day and not 1-2 times a day. RN-A stated P1 had been taking the calcium polycarbophil correctly twice a day and she had simply not updated the POC. RN-A and the administrator both confirmed the normal agency procedure was to reach out to a patient's provider with any order discrepancies on the POC to seek clarification and then update the POC accordingly. RN-A stated she had missed ensuring P1's orders were accurately listed on his POC P2 P2's plan of care (POC) with a certification period of 2/8/25 to 4/8/25, identified a (SOC) date of 10/17/19. Diagnoses included unspecified systolic (congestive) heart failure (a serious condition that occurs when the left ventricle can't pump blood efficiently), chronic obstructive pulmonary disease (COPD) (a common, preventable and treatable disease that is characterized by persistent respiratory symptoms like progressive breathlessness and cough), and type 2 diabetes with unspecified complications. P2 required skilled nursing visits (SNV) once every other week to help manage P2's diabetes, COPD, medications, coordination with medical providers and medication set-up. P2's VA Medication Reconciliation dated 2/13/25, identified the following: 1/24/25, isosorbide dinitrate (a nitrate that dilates (widens) blood vessels and prevent angina attacks (Chest discomfort or shortness of breath caused when heart muscles receive insufficient oxygen-rich blood) 10 milligram (mg) tablets. Take one tablet by mouth every morning, take one tablet by mouth at noon and take one tablet by mouth before bedtime. 1/4/25, ferrous sulfate 325 mg tablets. Take one tablet by mouth daily for iron supplement. RX expiration date 1/27/25. During entrance interview on 3/10/25, at 1:45 p.m. the administrator stated nurses were to complete a drug regimen review at start of care, with recertification visits and to ask the patient regarding changes to medications at every skilled nurse visit. During a home visit on 3/11/25 at 1:00 p.m., P2’ s medications were reviewed with registered nurse (RN)-A while RN-A set up P2’s medications into a plastic rectangle four-line medicine organizer and two plastic rectangle single line medicine organizers. The POC for the certification period 2/8/25 to 4/8/25 and the medication administration log RN-A referred to included isosorbide dinitrate 10 mg tablets. Take one tablet by mouth three times a day. RN-A was observed to not set up one isosorbide dinitrate tablet into the medicine organizers. Additionally, P2 had a bottle of ferrous sulfate 325 mg tablets. RN-A stated ferrous sulfate was not on P2’s POC or medication administration log and she would need to contact P2’s provider. Upon review of P2's VA Medication Reconciliation, RN-A stated the ferrous sulfate order was missed on P2's POC. During an interview on 3/11/25 at 3:43 p.m., RN-A stated she normally would dispense each medication, one at a time, and follow the medication orders while setting up P2's medications. "I don't know why I was distracted but I was and forgot to put the isosorbide dinitrate in." RN-A stated, regarding P2's ferrous sulfate physician order, P2's VA Medication Reconciliation was sent to the agency after P2's certification was complete, and she did not always know when medication changes occurred. However, RN-A stated she missed the ferrous sulfate order on P2's 12/12/24 Provider After Visit Summary nor the 3/10/25 VA Medication Reconciliation. P2 had not been receiving ferrous sulfate as ordered. RN-A stated "it's my error." P5 P5's plan of care (POC) with a certification period of 2/8/25 to 4/8/25, identified a start of care (SOC) date of 9/2/20. Diagnoses included hypertension (high blood pressure), polyosteoarthritis (a diagnosis that means five or more of your joints have arthritis at the same time) and hypertensive heart disease without heart failure (a condition caused by high blood pressure over a long time). P2 required skilled nursing visits (SNV) once every other week to help manage P5’s condition, monitor and manage care as well as set up medications and ordering medications. P5’s Interagency Referral Form dated 1/25/25, identified the following: Amlodipine 10 mg tablets. Take 1 tablet by mouth every day; and Aspirin EC (enteric coated) 81 mg tablets. Take 1 tablet by mouth every day. P5’s plan of care (POC) for the certification period 2/8/25 to 4/8/25, identified the following: Amlodipine 5 mg tablet. Take 1 tablet by mouth every day; and Aspirin 81 mg tablet. Take 1 tablet by mouth every day. - During an interview on 3/11/25 at 3:54 p.m., RN-A reviewed P5’s POC. RN-A stated “yes, those are errors." RN-A stated she was aware any time a client received a new physician order, the POC should be updated. However, RN-A did not update the POC when P5’s orders were received. During a phone interview on 3/11/25 at 4:01 p.m., the director of nursing (DON) stated medication reconciliation was critical to be correct to ensure the safety and health of the patient. The 485 is expected to be updated with changes as soon as the agency was notified.

Only as ordered by a physician CFR(s): 484.60(b)(1) Drugs, services, and treatments are administered only as ordered by a physician or allowed practitioner. This ELEMENT is not met as evidenced by: Based on observation, interview and document review, the agency failed to ensure medications were administered only as ordered by a physician or allowed practitioner for 1 of 2 patients (P2) observed during a skilled nursing home visit. P2's plan of care (POC) with a certification period of 2/8/25 to 4/8/25, with a start of care (SOC) date of 10/17/19. Diagnoses included unspecified systolic (congestive) heart failure (a serious condition that occurs when the left ventricle can't pump blood efficiently), chronic obstructive pulmonary disease (COPD) (a common, preventable and treatable disease that is characterized by persistent respiratory symptoms like progressive breathlessness and cough), and Type 2 diabetes with unspecified complications. P2 required skilled nursing visits (SNV) once every other week to help manage P2's diabetes, COPD, medications, coordination with medical providers and medication set-up. P2's VA Medication Reconciliation dated 2/13/25, identified the following: 1/24/25, isosorbide dinitrate (a nitrate that dilates (widens) blood vessels and prevent angina attacks (Chest discomfort or shortness of breath caused when heart muscles receive insufficient oxygen-rich blood) 10 milligram (mg) tablets. Take one tablet by mouth every morning, take one tablet by mouth at noon and take one tablet by mouth before bedtime. 1/4/25, ferrous sulfate 325 mg tablets. Take one tablet by mouth daily for iron supplement. RX expiration date 1/27/25. During a home visit on 3/11/25 at 1:00 p.m., P2’ s medications were reviewed with registered nurse (RN)-A while RN-A set up P2’s medications into a plastic rectangle four-line medicine organizer and two plastic rectangle single line medicine organizers. The POC for the certification period 2/8/25 to 4/8/25 and the medication administration log RN-A referred to included isosorbide dinitrate 10 mg tablets. Take one tablet by mouth three times a day. RN-A was observed to not set up one isosorbide dinitrate tablet into the medicine organizers. Additionally, P2 had a bottle of ferrous sulfate 325 mg tablets. RN-A stated ferrous sulfate was not on P2’s POC or medication administration log and she would need to contact P2’s provider. Upon review of P2's VA Medication Reconciliation, RN-A stated the ferrous sulfate order was missed on P2's POC. During an interview on 3/11/25 at 3:43 p.m., RN-A stated she normally would dispense each medication, one at a time, and follow the medication orders while setting up P2's medications. "I don't know why I was distracted but I was and forgot to put the isosorbide dinitrate in." RN-A stated, regarding P2's ferrous sulfate physician order, P2's VA Medication Reconciliation was sent to the agency after P2's certification was complete, and she did not always know when medication changes occurred. However, RN-A stated she missed the ferrous sulfate order on P2's 12/12/24 Provider After Visit Summary nor the 3/10/25 VA Medication Reconciliation. P2 had not been receiving ferrous sulfate as ordered. RN-A stated "it's my error." During a phone interview on 3/11/25 at 4:01 p.m., the director of nursing (DON) stated medication administration was critical to be correct to ensure the safety and health of the patient. The 485 is expected to be updated with changes as soon as the agency is notified. A medication error policy was requested but not received.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure client code status was accurately identified on the plan of care for 1 of 7 patients (P5) reviewed for code status. P3's plan of care (POC) dated 1/3/25 to 3/3/25, identified a start of care (SOC) 7/23/21. Diagnoses included diabetes, kidney disease, and malignant neoplasm of the kidney. Services included skilled nurse visits (SNV) every other week for nine weeks for various assessments, medication management, and education. The advanced directives on the POC identified P3 did not have advanced directives on file at the agency, however, under intent was a note that identified CPR (cardio-pulmonary resuscitation). P3's POC 3/4/25 to 5/2/25, identified a SOC 7/23/21, with diagnoses which included diabetes, kidney disease and malignant neoplasm of the kidney. Services included SNV every other week for nine weeks for various assessments, medication management, and education. The advanced directives on the POC identified P3 did not have advanced directives on file at the agency, however, under intent was a note that identified CPR. P3's medical record identified a Barnabas Health Care Services CPR-DNR (cardio-pulmonary resuscitation/Do not attempt resuscitate) form dated 12/17/24. The form identified P3 had chosen a DNR (do not resuscitate). Recommended action directed staff not to call 911 for CPR, but staff could call for urgent needs with active treatment up to the point of CPR. If P3 was in cardio-pulmonary arrest, staff were not to intubate, give ventilatory assistance, chest compressions or defibrillation. During interview on 3/10/25, at 3:51 p.m., registered nurse (RN)-A stated the note, which identified CPR on P3's POC was in error, and she would see that it was corrected immediately. RN-A stated it was important to have the code status reflected accurately on the patient's POC. The agency typically had patients who had signed a code status, hung a copy on their refrigerator, and that is where emergency or home care personnel would look in an emergency. When interviewed on 3/10/25, at 4:00 p.m., the administrator stated staff were to ensure the patient's POC had the correct CPR status as identified on the patient's code status form. The patient kept a copy of the code status form in their home and the agency kept the form in the medical record. The administrator stated the primary physician signed the patient's POC and that needed to match with the code status form. The agency policy, Advance Directives, CPR-DNR, reviewed June 2022, identified if a client did not have an Advanced Directive, he/she must identify the level of care to be rendered and sign the Barnabas CPR-DNR form. The form must be submitted to the client's physician for review and signature. Once a signed copy was received, it would be filed in the client's chart. The form was valid for one year and must be provided and updated to the client during recertification (annually).

Non-skilled direct observation every 60 days CFR(s): 484.80(h)(2) If home health aide services are provided to a patient who is not receiving skilled nursing care, physical or occupational therapy, or speech-language pathology services, — (A) The registered nurse must make an onsite, in person visit every 60 days to assess the quality of care and services provided by the home health aide and to ensure that services meet the patient's needs; and (B) The home health aide does not need to be present during this visit. (ii) Semi-annually the registered nurse must make an on-site visit to the location where each patient is receiving care in order to observe and assess each home health aide while he or she is performing non-skilled care This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to ensure a registered nurse made an onsite, in person visit every 60 days for personal care attendant (PCA) supervision for 2 of 2 patients (P8, P9) reviewed for non-skilled agency patients receiving PCA services under the agency's comprehensive home care license. P8's plan of care (POC) 11/28/24 to 1/26/25, identified a start of care (SOC) date of 12/9/13. Diagnoses included severe intellectual disabilities and cerebral palsy. Services included a nursing visit every 60 days for recertification, personal care attendant (PCA) supervision and care plan review and update. A PCA was ordered 10. 5 hours daily with flex use. P8's POC 1/27/25 to 3/27/25, identified a SOC date 12/9/13. Diagnoses included severe intellectual disabilities and cerebral palsy. Services included a nursing visit every 60 days for recertification, PCA supervision and care plan review and update. A PCA was ordered 10. 5 hours daily with flex use. P8's Service Agreement dated 10/26/16, identified the client or responsible party agreed to registered nurse supervision of PCA every 60 days and PCA services for 10.5 hours per day. P8's nurse visit notes identified the following nurse visits were conducted: -On 1/13/25, a remote nurse visit was done over telephone for P8's recertification visit and PCA supervision due to inclement weather and illness in the community. -On 11/18/24, a nurse visit was made to the home for in-person recertification and PCA supervision. -On 9/23/24, a remote nurse visit was done over telephone for P8's recertification visit and PCA supervision. P9's POC 11/28/24 to 1/26/25, identified a SOC 1/1/06. Diagnoses included moderate intellectual disabilities, spastic hemiplegia and bipolar disorder. Services included nurse visit every 60 days for recertification, PCA supervision, and care plan review/update. A PCA was ordered 11 hours a day, flex use. P9's POC 1/27/25 to 3/27/25, identified a SOC 1/1/06. Diagnoses included moderate intellectual disabilities, spastic hemiplegia and bipolar disorder. Services included nurse visit every 60 days for recertification, PCA supervision, and care plan review/update. A PCA was ordered 11 hours a day, flex use. P9's Service Agreement dated 9/1/20, identified the client or responsible party agreed to registered nurse supervision of PCA every 60 days and PCA services for 10.5 hours per day. P9's nurse visit notes identified the following nurse visits were conducted: -On 1/13/25, a remote nurse visit was done over telephone for P8's recertification visit and PCA supervision due to inclement weather and per PCA request as there was so much illness in the community. -On 11/18/24, a nurse visit was made to the home for in-person recertification and PCA supervision. -On 9/23/24, a remote nurse visit was done over telephone for P8's recertification visit and PCA supervision. During interview on 3/11/25, at 3:30 p.m., registered nurse (RN)-A stated she usually did on-site recertification and PCA supervision for all her patients but P8 and P9 did not want her to visit. The patients and families were worried about getting an infection or sick from staff, so she did the recertification by phone, and the doctor had written an order that it would be ok to do it that way. During interview on 3/11/25, at 3:40 p.m., the administrator stated she thought if they had an order from the doctor, they would not have to go on site every 60 days but could go annually instead. The PCA Qualified Professional Services from the PCA manual identified the agency could conduct the required supervision remotely for a person with chronic health conditions or a severely compromised immune system when the provider determines remote supervision was appropriate. The administrator stated the agency did not have a separate PCA licensure and provided the client's PCA services under their comprehensive home health care licensure, which did not stipulate the same exception to the regulation. The administrator stated the agency did do on-site PCA supervision every 60 days with all their patients except P8 and P9, as they became upset and refused to allow the nurse to come. The agency policy Nurse Supervision dated February 2025, identified unlicensed staff such as the PCA would be supervised by the supervising RN every 60 days for recertification to the location where the client was receiving care to observe and assess while they are performing care. The PCA must be present during the supervision visit

A survey with CMS Appendix Z Emergency Preparedness Requirements, was conducted on 1/30/23, 1/31/23, 2/1/23 and 2/2/23, during a recertification survey. The facility is NOT in compliance with the Appendix Z Emergency Preparedness Requirements.

EP Testing Requirements CFR(s): 484.102(d)(2) §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, OPO, "Organizations" under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility's] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient's home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility's] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility's] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility's emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI's and OPO's] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI's response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI's emergency plan, as needed. This STANDARD is not met as evidenced by: Based on interview and document review the facility failed to participate in a full scale emergency exercise, and or a table top exercise at least annually. This deficient practice had the potential to affect all 32 clients receiving services from the agency. A review of the facility's emergency preparedness plan was conducted on 2/1/23. The emergency plan included various polices which addressed such emergencies as tornado, cold weather and priority classification of patients . However, the emergency plan did not include documentation the facility had participated in a full scale or a table top emergency exercise with community. During an interview on 2/1/23, at 11:15 a.m. the administrator stated there had been no annual testing or desktop drill of the emergency plan or any table top testing completed within the home health agency or with the community. The agency's policy All Hazzard Emergency Preparedness Plan dated June 2021, did not identify the need for the facility to participate in a table top and full scale community exercise if available annually. No further information was provided.

On 1/30/23, 1/31/23, 2/01/23 and 2/02/23, a partially extended survey was conducted at your agency. The agency was found to have not met the requirements at 42 CFR. Part 484 for Home Health Agencies. Unduplicated census: 31 Total home visits conducted: 03 No Branch offices. Hours of Operation: 9:00 a.m. to 5:00 p.m. Total number of records reviewed: 09

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 interview and document review, the agency failed to ensure each patient had an initial assessment visit within 48 hours of the referral date for 4 of 7 patients (P3, P4, P6, P7) reviewed, in the sample. P3's plan of care (POC) for certification period 12/10/22 to 2/7/23, indicated a start of care (SOC) date 10/11/22. Diagnoses included dementia and obesity. P3's Patient Inquiry form dated 9/21/22, identified a referral for home care services for homemaker (HMK) and home health aide (HHA) services. P3's start of care assessment visit was not completed until 10/11/22. The clinical record failed to identify any reason P3 had not been assessed within 48 hours of the referral date of 9/21/22, and lacked evidence P3's physician was notified of the delay in the SOC date. P4's POC for certification period 12/21/22 to 2/18/23, indicated a SOC date 9/2/20. Diagnoses included hypertensive heart disease. P4's Patient Inquiry form dated 8/26/20, identified a referral for home care services for evaluation and treatment and medication set up and compliance. P4's SOC assessment visit was not completed until 9/2/20. The clinical record failed to identify why P4 had not been assessed within 48 hours of the referral date of 8/26/20, and lacked evidence P4's physician was notified of the delay in the SOC date. P6's POC for certification period 11/16/22 through 1/14/23, indicated a SOC date 7/19/22. Diagnoses included essential hypertension. P6's Patient Inquiry form dated 7/13/22, identified a referral for home care services due to client difficulty organizing and ordering medications and need to assess adequacy of home environment and patients ability to provide care. P6's SOC assessment visit was not completed until 7/19/22. The clinical record failed to identify why P6 had not been assessed within 48 hours of the referral date of 7/13/22, and lacked evidence P6's physician was notified of the delay in the SOC date. P7's POC for certification period 6/2/22 through 7/31/22, indicated a SOC date 6/2/22. Diagnoses included abnormal gait and mobility, peripheral autonomic neuropathy and dyspnea. P7's Patient Inquiry form dated 5/23/22, identified a referral for home care services for evaluation and treatment and need for assistance with bathing. P7's SOC assessment was not completed until 6/2/22. The clinical record failed to identify why P7 had not been assessed within 48 hours of the referral date of 6/22/22, and lacked evidence P7's physician was notified of the delay in the SOC date. During interview on 2/1/23, at 2:45 p.m. the administrator stated the faxed Patient Inquiry was the agency's referral for services. The administrator screened the referrals and filled out the Client Intake Assessment form when she received the inquiry for services. The administrator recorded the referral date and time with the date a registered nurse (RN) would be available to complete the assessment. The administrator did call the physician's office and client to make ensure the date for SOC would be ok, however, did not obtain separate SOC orders or document the calls. The Patient Inquiry referral was used for the agency's SOC orders. The agency did not obtain or document the physician communication or orders for a different SOC date in the patient's medical record. The agency's policy Admission Criteria/Procedure dated February 2022, indicated a registered nurse (RN) must conduct an initial assessment visit to determine the immediate care and support needs of the client. The initial assessment visit must be completed within 48 of referral or 48 hours of the client's return home from the hospital or on the physician ordered SOC date.

At discharge CFR(s): 484.55(d)(3) At discharge. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to complete a comprehensive discharge assessment when the agency discharged a patient from skilled nursing care for 1 of 2 skilled patients (P6), reviewed. P6's plan of care (POC) for certification period 11/16/22 through 1/14/23, indicated a start of care (SOC) date 7/19/22. Diagnoses included essential hypertension. The POC indicated P6 received skilled nurse visits every other week for medication setup as well as various assessments to manage multiple medical issues, coordination with physician appointments and ordering medications. P6's SNV dated 1/10/23, indicated coordination and education was completed in preparation of P6's discharge from the agency for noncompliance. 10 day notice was given of the impending discharge and P6's physician was updated. P6's medical record indicated the last day of agency services would be 1/20/23. The medical record lacked evidence of a comprehensive discharge assessment and summary was completed. When interviewed on 2/1/23, at 2:45 p.m. the administrator stated if a discharge summary was not in P6's medical record then it was not completed. The nurses were aware the agency required a discharge summary to be completed whenever the agency discharged a patient. The administrator was unsure why one had not been done. The agency's policy Transfer, Discharge or Termination for Service dated February 2022, directed staff to complete a discharge summary within five business days of the client's discharge. The discharge summary would be written and submitted to physician and filed in the client chart. The discharge summary must include at least the following: date of discharge, client's identifying information, client's physician name and phone number, diagnosis, reason for discharge, instructions given to client, client's health status at discharge and summary of services.

Discharge or Transfer Summary Content CFR(s): 484.58(b)(1) Standard: Discharge or transfer summary content. The HHA must send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, to the receiving facility or health care practitioner to ensure the safe and effective transition of care. This STANDARD is not met as evidenced by: Based on interview and document review, the agency failed to send all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care and treatment preferences, to the receiving facility to ensure a safe and effective transition of care for 1 of 2 patients (P7) reviewed, who were transferred from the agency. P7's plan of care (POC) for certification 6/2/22 through 7/31/22, indicated start of care (SOC) 6/2/22. Diagnoses included abnormal gait and mobility, peripheral autonomic neuropathy and dyspnea. P7 received weekly skilled nurse visits (SNV) to assess and evaluate P7's condition, monitor and manage his care and setup medications. A HHA was ordered four hours a week to assist with bathing and other activities of daily living (ADLs). P7's SNV progress note dated 7/18/22, indicated P7 was transferred to the hospital following an unresponsive episode during care. P7's POC update dated 7/19/22, indicated P7 had been admitted to the hospital and would be admitted to a skilled nursing facility on his discharge. P7 was discharged from the agency as of 7/18/22. P7's medical record lacked a transfer form detailing P7's necessary medical information pertaining to the current course of illness and treatment, medication and services he required and received from the agency while in his home. There was no documentation if any information, including a current medication list, was sent to the receiving hospital to help ensure a safe and effective transition of care. No discharge summary was completed. During interview on 2/1/23, at 2:45 p.m. the administrator stated if there wasn't a transfer form in P7's medical record then it had not been completed. The agency required a transfer summary when patient's were transferred and she did not know why one had not been completed for P7 when he was transferred. All patient's should have a current medication list in their home as well as the agency's admission packet they could bring with them when they were being transferred. The administrator was unable to find documentation any information was forwarded to the hospital following P7's transfer. The agency's policy Transfer, Discharge or Termination for Service dated February 2022, directed staff to complete a transfer summary within two business days of becoming aware of unplanned transfer. The transfer summary must include the following: date of transfer, client identifying information, emergency contact, destination of client transferred, date and name of person receiving report. physician and phone number. significant health history and diagnosis related to the transfer, a brief description of services provided and ongoing needs that cannon be met, status of client a the time of transfer, transfer orders and instructions, complete and current medication profile. The client would be provided with the name, address, telephone number and contact name at the referral organization and documentation in the client record of the referral or notice as well as copy of the transfer summary, current plan of care, general summary of health history and discharge orders.

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 interview and document review, the agency failed to identify the duration of visits to be made on the plan of care for 6 of 7 patients (P1, P3, P4, P5, P6, P7), reviewed in the sample. P1's plan of care (POC) for certification period 1/14/23 through 3/14/23, indicated a start of care (SOC) date 7/23/21. Diagnoses included kidney disease and diabetes. P1 services ordered skilled nurse visits (SNV) every other week. P1's POC and medical record lacked orders for the duration of services in the POC as required. P3's plan of care (POC) for certification period 12/10/22 to 2/7/23, indicated a start of care (SOC) date 10/11/22. Diagnoses included dementia and obesity. P3's services ordered SNV every other week and as needed (PRN) for changes in condition. Home health aide (HHA) supervision would be done every 60 days. HHA visits were ordered three times per week. P3's POC and medical record lacked orders for the duration of services in the POC as required. P4's POC for certification period 12/21/22 to 2/18/23, indicated a SOC date 9/2/20. Diagnoses included hypertensive heart disease. SNV were ordered weekly, PRN, and Every 60 days for recertification and supervision. HHA visits were ordered two hours per week. P4's POC and medical record lacked orders for the duration of services in the POC as required. P5's POC for certification period 12/5/22 through 2/2/23, indicated a SOC 10/6/22. Diagnoses included burns involving 20-29% of body surface and skin transplant status. SNV were ordered five times per week. P5's POC and medical record lacked orders for the duration of services in the POC as required P6's POC for certification period 11/16/22 through 1/14/23, indicated a SOC date 7/19/22. Diagnoses included essential hypertension. SNV were ordered every other week and PRN for changes in condition. P6's POC and medical record lacked orders for the duration of services in the POC as required. P7's POC for certification period 6/2/22 through 7/31/22, indicated a SOC date 6/2/22. Diagnoses included abnormal gait and mobility, peripheral autonomic neuropathy and dyspnea. SNV were ordered weekly and PRN. P7's POC and medical record lacked orders for the duration of services in the POC as required. During interview on 1/31/23, at 12:00 p.m. registered nurse (RN)-A stated she included frequency and duration of visits on her Medicare clients but was not aware it was required for all patient POC's. Now she was aware and would include the duration on all her visit orders. When interviewed on 2/1/23, at 2:45 p.m. the administrator stated she thought the duration for visits was just a Medicare requirement and did not need to be done for everyone's POC. The agency's policy Care Planning dated January 2021, indicated the plan of care, developed in accordance with the referring physician orders would include orders for all disciplines to include amount, frequency and duration.

All orders recorded in plan of care CFR(s): 484.60(a)(3) All patient care orders, including verbal orders, must be recorded in the plan of care. This ELEMENT is not met as evidenced by: Based on observation interview and document review, the agency failed to update the plan of care to reflect current treatment implemented for 1 of 2 patients (P3) reviewed for treatments. P3's plan of care (POC) for certification period 12/20/22 through 2/7/23, indicated a start of care date (SOC) 10/11/22. Diagnoses included dementia and obesity. Orders included skilled nurse visits every other week and PRN for changes in condition to assist in monitoring and managing his comorbidities and medications. Home health aide visits three times per week to provide assistance with P3's activities of daily living (ADLs). The POC did not identify the use of medical compression wraps with air compression or compression leg wraps. P3's medical record lacked physician orders for the use of medical compression wraps with air compression, including the frequency and duration of use as well as orders for compression leg wraps following use of the air compression wraps, including frequency and duration of use. During a home visit on 2/1/23, at 8:00 a.m. home health aide (HHA)-B was observed to assist P3 with a shower. Following the shower, HHA-B applied farrow wraps (a short stretch adjustable compression device garment) to both of P3's calves and attached plastic tubing to the wraps. HHA-B turned on a compressor located on a table next to the recliner. HHA-B stated the machine was preset with the amount of compression to apply and she just turned the machine on. HHA-B indicated the agency's registered nurse had verbally explained the procedure to her and she knew how tightly to secure the wraps because P3's spouse demonstrated the procedure. P3's spouse had demonstrated to her how to apply the medical air compression leg wraps and HHA-B put them on for 1/2 hour each visit three times per week. After 1/2 hour she shut the machine off, removed the wraps and wrapped P3's legs with compression wraps for him to wear the remainder of the day. P3's Aide Care Plan dated 10/12/22, did not include instruction for application of P3's medical compression wraps with air compression or regular compression wraps. On 1/31/23, an update to the care plan was documented to include special details of application of P3's compression wraps. Registered nurse (RN)-A attached a handwritten note which indicated she had updated the care plan on 1/31/23, to ensure the details of the compression wraps were included. During interview on 2/2/23, at 9:30 a.m. RN-A stated she had verbally instructed HHA-B about the compression wraps over the phone and told her to have the spouse guide her through the procedure. RN-A instructed HHA-B to do the air hose wraps for 30 minutes then put on P3's compression wraps on over his socks, starting with wrapping at the foot and working up. RN-A indicated she updated the Aide Care Plan on 1/31/23, to ensure the details on the wraps were documented to instruct the aides. RN-A verified P3's medical record lacked orders for the medical air compression leg wraps as well as the compression wraps currently in use. They were unable to add medical tasks to the POC orders, however, a verbal order for the treatment had never been completed. RN-A indicated she would add orders for the compression wrap treatment after her next home visit, as she needed to obtain the exact information from P3's compression wrap compressor as well as the instructions from his compression wraps that were in the home. When interviewed on 2/1/23, at 9:20 a.m. the administrator stated she was not aware orders were needed for the application of ted hose or compression wraps. The agency's policy Physician Orders/Plan of Care dated October 2021, indicated the physician would set up a plan of care which would include treatments and an order for each service, item of drugs and equipment to be provided by the agency. The agency's policy Care Planning dated January 2021, indicated the plan of care would include treatments and orders. The plan of care would be based on the physician orders and encompass the equipment, supplies, disciplines, and services required to meet the client's needs.

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 interview and document review, the agency failed to ensure the physician orders were followed for 1 of 7 patients (P5) who had in home physical therapy and in home occupational therapy ordered, but the services had not been provided, and the physician had not been notified the services were not provided. P5's POC for certification period 12/5/22 through 2/2/23, indicated a SOC 10/6/22. Diagnoses included burns involving 20-29% of body surface and skin transplant status. Skilled nurse visits (SNV) were ordered five times per week for various assessments and monitoring and wound care with dressing changes. Patient specific interventions identified P5's arms and hands had limited mobility. Rehabilitation potential indicated P5 potential was good due to his age and overall health. P5's discharge summary dated 10/4/22, indicated home care services referral which included orders for outpatient and in home physical therapy (PT) and occupational therapy (OT). The in home therapies were ordered to address P5's stretching and decreased functional mobility due to concerns with P5's burns. . P5's medical record lacked documentation of physician notification of the agency's inability to provide in home physical or occupational therapy to patients as well as physician order to discontinue the in home therapies ordered. When interviewed on 1/31/23, at 12:00 p.m. registered nurse (RN)-A stated she was sure the administrator had notified the referring physician that the agency was not able to provide in home therapies. In home therapy had not been offered to P5, as the agency did not have the ability to provide the services. RN-A was unable to find a physicians order to discontinue in home therapy. During interview on 2/1/23, at 9:20 a.m. the administrator stated in home therapies had been ordered on P5's discharge summary, but she had explained to the veteran's community health nurse that their agency was unable to provide in home therapy and they were ok with that. The administrator indicated she had not documented the conversation and a verbal order to discontinue the in home PT and OT had not been obtained. The agency's policy Physician Orders/Plan of Care dated October 2020, indicated the physician set up a plan of care which would include the diagnosis, prognosis, medications, frequency and type of services, treatments, diet, goals to be accomplished, an order for each service, item of drugs and equipment to be provided by the agency. All orders on the POC would be specific to the client condition and needs. Case managers would review the clinical record to determine adequacy of the plan of treatment and the appropriateness of the continuation of care. The agency's policy Admission Criteria/Procedure dated February 2022, indicated clients would be accepted for services on the reasonable expectation the client's health care/rehabilitation needs could be met adequately in the client's place of residence.

Program activities CFR(s): 484.65(c) Standard: Program activities. The HHA's performance improvement activities must-- This STANDARD is not met as evidenced by: Based on interview and document review the facility failed to identify specific performance measures for implementation to improve the patient outcomes related to medication safety, hospitalization, emergency room visits, nutrition, falls, and malnutrition as indicated on the tracking spreadsheet. This had the potential to affect all 31 patients receiving services from the agency. On 1/30/23, at 11:35 a.m. the administrator stated the quality assurance program (QAPI) was being managed by the director of nursing (DON) who decided which problems QAPI would track based on the updates she received. LPN-A accumulated the QAPI data on a spreadsheet and that information was reviewed. The agency did not setup formal QAPI meetings and did not document when they met. Review of the QAPI data 1/1/22 through 12/31/22, identified tracking indicators had been identified, however, analysis of the statistics or plan to address the findings were not identified. On 2/2/2, at 10:50 a.m. the administrator stated the agency's QAPI program listed the quarterly data for COVID, medication safety, hospitalizations, emergency room visits, nutrition, and falls. The program just consisted with gathering the data. The administrator indicated the quality assurance and performance improvement process did not identify specific performance measures for implementation to improve patient outcomes, as she was not sure exactkt what was needed. The agency did not include analysis of this process, and lacked any further information outside of the tracking spreadsheet. A policy for QAPI was requested, however, was not received.

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: Based on interview and document review, the facility failed to ensure 6 of 20 staff members , licensed practical nurse (LPN)-A, home health aide (HHA)-A, HHA-B, HHA-C, personal care attendant (PCA)-A, and housekeeper (HSK)-A, were vaccinated with a complete primary series of COVID-19 vaccine and/or had an approved or pending exemption on record. This resulted in a vaccination rate of 70% and had potential to affect all 31 clients receiving services from the agency. The Centers for Medicare and Medicaid (CMS) QSO-23-02-ALL, dated 10/26/22, identified the revised guidance for staff vaccination requirements. The QSO outlined the requirement for full staff vaccination had been enforced since February 2022, and listed a section labeled, "Vaccination Enforcement," which outlined, "CMS expects all providers' and suppliers' staff to have received the appropriate number of doses of the primary vaccine series unless exempted as required by law, or delayed as recommended by the CDC [Centers for Disease Control]. Facility staff vaccination rates under 100% constitute noncompliance under the rule." During the recertification survey, from 1/30/23 to 2/2/23, evidence of staff vaccinations was requested. An undated Staff COVID Vaccine Status listing, provided by the administrator, demonstrated all staff members vaccination status with completed primary series date(s), and any provided booster doses of COVID-19 vaccines. This listing identified a total of 20 staff members. However, three staff members, licensed practical nurse (LPN)-A, home health aide (HHA)-A, HHA-B, only had the first dose of a two-dose primary vaccine series completed and another three staff members, personal care attendant (PCA)-A, and housekeeper (HSK)-A, and HHA-C had not received the recommended booster required. The listing identified staff who had received religious exemptions, however, none of the six staff members were identified as having filed or received an exemption. On 1/31/23 at 10:00 a.m., LPN-A was interviewed and verified she was not fully vaccinated and had only received one dose of the Pfizer (i.e., two-part series) vaccine, and then decided she did not want the second dose. LPN-A stated she had already received the first dose of the vaccine prior to working for the agency and was not aware an exemption form was needed, as she had already had one dose. There was no additional information presented demonstrating why HHA-A, or HHA-B's primary vaccination series was not completed despite the first dose being administered. There was no additional information presented demonstrating why HHA-C, PCA-A and HSK-A had not received the recommended booster after completing the two part series vaccine. On 1/31/23 at 2:00 p.m., the administrator stated she was not aware staff needed exemptions if they had not completed the full vaccination series. The agency only required the staff who refused the vaccine entirely to fill out exemption forms. The administrator would have the staff who were not up to date with the COVID-19 vaccination series fill out exemption forms as soon as possible. A provided COVID-19 Vaccinations Infection Control and Prevention, dated 10/2022, identified a purpose to ensure staff who provided care and treatment were fully vaccinated and followed precautions to prevent the transmission and spread of COVID-19 to clients and other staff. Staff who provide any care, treatment or other services for the agency were required to be fully vaccinated for COVID-19. Any staff who refused to be vaccinated due to religious or medical exemption must provide in writing an exemption to the vaccination requirement. The exemption request must be submitted and approved by the DON.

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 observation, interview and document review, the agency failed to ensure home health aides provided services ordered by the physician, included in the plan of care and consistent with the home health aide training for 1 of 1 patients (P3) with home health aide services for personal care, observed during a home visit. P3's plan of care (POC) for certification period 12/20/22 through 2/7/23, indicated a start of care date (SOC) 10/11/22. Diagnoses included dementia and obesity. Orders included skilled nurse visits every other week and PRN for changes in condition to assist in monitoring and managing his comorbidities and medications. Home health aide visits three times per week to provide assistance with P3's activities of daily living (ADLs). The POC did not identify the use of medical compression wraps with air compression or compression leg wraps. P3's medical record lacked physician orders for the use of medical compression wraps with air compression, including the frequency and duration of use as well as orders for compression leg wraps following use of the air compression wraps, including frequency and duration of use. During a home visit on 2/1/23, at 8:00 a.m. home health aide (HHA)-B was observed to assist P3 with a shower. Following the shower, HHA-B applied farrow wraps (a short stretch adjustable compression device garment) to both of P3's calves and attached plastic tubing to the wraps. HHA-B turned on a compressor located on a table next to the recliner. HHA-B stated the machine was preset with the amount of compression to apply and she just turned the machine on. HHA-B indicated the agency's registered nurse had verbally explained the procedure to her and she knew how tightly to secure the wraps because P3's spouse demonstrated the procedure. P3's spouse had demonstrated to her how to apply the medical air compression leg wraps and HHA-B put them on for 1/2 hour each visit three times per week. After 1/2 hour she shut the machine off, removed the wraps and wrapped P3's legs with compression wraps for him to wear the remainder of the day. P3's Aide Care Plan dated 10/12/22, did not include instruction for application of P3's medical compression wraps with air compression or regular compression wraps. On 1/31/23, an update to the care plan was documented to include special details of application of P3's compression wraps. Registered nurse (RN)-A attached a handwritten note which indicated she had updated the care plan on 1/31/23, to ensure the details of the compression wraps were included. During interview on 2/2/23, at 9:30 a.m. RN-A stated she had not taken HHA-B out to the home to demonstrate P3's compression wraps, but she had instructed her over the phone and told her to have the spouse guide her through the procedure. RN-A instructed HHA-B to do the air hose wraps for 30 minutes then put on P3's compression wraps on over his socks, starting with wrapping at the foot and working up. No demonstration had been given to HHA-B nor had a return demonstration been done to verify competency. RN-A indicated she updated the Aide Care Plan on 1/31/23, to ensure the details on the wraps were documented to instruct the aides. RN-A verified P3's medical record lacked orders for the medical air compression leg wraps as well as the compression wraps currently in use. They were unable to add medical tasks to the POC orders, however, a verbal order for the treatment had never been completed. RN-A indicated she would add orders for the compression wrap treatment after her next home visit, as she needed to obtain the exact information from P3's compression wrap compressor as well as the instructions from his compression wraps that were in the home. HHA-B's Validation of HHA Skills dated 3/23/22, did not include skills for application compression wraps or ace wraps. When interviewed on 2/1/23, at 9:20 a.m. the administrator stated she was not aware orders were needed for the application of ted hose or compression wraps. The agency's policy Physician Orders/Plan of Care dated October 2021, indicated the physician would set up a plan of care which would include treatments and an order for each service, item of drugs and equipment to be provided by the agency. The agency's policy Care Planning dated January 2021, indicated the plan of care would include treatments and orders. The plan of care would be based on the physician orders and encompass the equipment, supplies, disciplines, and services required to meet the client's needs.

On 2/7/22 through 2/14/22, and 2/22/22 through 2/23/22, an abbreviated on-site survey was conducted. The agency was NOT in compliance with requirements at 42 CFR Part 484 requirements for Home Health Agencies. The cumulative effects of these findings resulted in the home health agency's inability to ensure provision of quality of care. The following complaint were found to be substantiated: H8048004C (61853) The following deficiencies were cited as a result of the investigation: G406, G462, G484, G488, G680, G682, G684, G687, G1022 The Condition of Participation: 484.50 Patient rights was not met at G406. The Condition of Participation: 484.70 Infection prevention and control was not met at G680. An immediate jeopardy was identified at G684: The immediate jeopardy began on 2/10/22, when the agency failed to maintain and document an infection control program and was identified on 2/10/22. The director of nursing (DON)/owner and administrator were notified of the immediate jeopardy at 1:00 p.m. on 2/10/22. The immediate jeopardy was removed on 2/23/22, when the agency developed and implemented policies and procedures to track staff and patient illnesses, report applicable illness to the appropriate officials, develop quarantine and return to work policies as recommended by the CDC and monitor and enforce the agency’s personal protective equipment (PPE) policies with all staff. An immediate jeopardy was identified at G687: The immediate jeopardy began on 1/27/22, when the agency failed to develop policies and procedures to ensure all staff were vaccinated for COVID-19, failed to develop a process to track and document staff vaccination status, failed to develop a process by which staff may request an exemption for COVID-19 vaccination requirements, and failed to develop a contingency plan for staff who were not fully vaccinated and was identified on 2/8/22, at 4:14 p.m. The director of nursing (DON)/owner and administrator were notified of the immediate jeopardy at 4:14 p.m. on 2/8/22. The immediate jeopardy was removed on 2/23/22, when the agency developed and implemented policies and procedures to address tracking and documentation of the agency's staff vaccination status, developed a contingency plan which included a deadline for unvaccinated staff to have received their first dose of a COVID-19 vaccine and implemented additional precautions to mitigate the spread of COVID-19 by unvaccinated staff. As a result, an extended survey was conducted.

Patient rights CFR(s): 484.50 Condition of participation: Patient rights. The patient and representative (if any), have the right to be informed of the patient's rights in a language and manner the individual understands. The HHA must protect and promote the exercise of these rights. This CONDITION is not met as evidenced by: Based on interview and document review, the agency failed to discharge 3 of 8 patients (P4, P1, and P2) for an appropriate cause, and did not report potential neglect to the state agency when they were discharged with continued care needs and no resources. In addition, based on interview and document review, the agency failed to have a system for documenting, investigating and resolving complaints made by patients, which had the potential to affect all patients served by the agency. In addition, the agency failed to train staff on how to file a vulnerable adult report for suspected or actual neglect or abuse. These combined failures resulted in Condition level noncompliance. See G462: The agency failed to discharge 3 of 8 patients (P4,P1, and P2) who were covered under Veteran's Affairs (VA) for appropriate cause, when the patient's were discharged from the agency without notice or assistance in identifying other entities in the area that may be able to meet the patient's needs. Further, the agency failed to document in the patient's clinical record the behaviors and circumstances that warranted patient discharge for cause, as well as the agency's efforts to resolve the problem. See G484: The agency failed to document any of the complaints the agency received, the investigation of complaints received or the resolution of the complaints received. The agency practice had the potential to affect all 32 patients currently served by the agency. See G488: The agency failed to immediately report to the State Agency (SA), an allegation of neglect for 1 of 8 patients (P1) when the agency discharged P1 without notice or resources and who lived alone and needed assistance with bathing and medication set up. Further, the agency failed to train staff on identification and timely reporting of abuse, neglect, misappropriation of property or injury of unknown origin. This had the potential to affect all 32 patients who received services with the home care agency.

Before discharge for cause HHA must: CFR(s): 484.50(d)(5) The HHA determines, under a policy set by the HHA for the purpose of addressing discharge for cause that meets the requirements of paragraphs (d)(5)(i) through (d)(5)(iii) of this section, that the patient's (or other persons in the patient's home) behavior is disruptive, abusive, or uncooperative to the extent that delivery of care to the patient or the ability of the HHA to operate effectively is seriously impaired. The HHA must do the following before it discharges a patient for cause: This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to discharge 3 of 8 patients (P1, P2, P4) who were covered under Veteran's Affairs (VA) for appropriate cause, when the patient's were discharged from the agency without notice or assistance in identifying other entities in the area that may be able to meet the patient's needs. Further, the agency failed to document in the patient's clinical record the behaviors and circumstances that warranted patient discharge for cause, as well as the agency's efforts to resolve the problem. P4's recertification period 8/16/21 through 10/14/21, indicated a start of care (SOC) date of 8/16/21. P4's diagnoses included acute myocardial infarction, aortocoronary bypass graft and pacemaker placement. A skilled nursing visit (SNV) was ordered every other week to assess and manage P4's co-morbidities, including setting up extensive amount of medications due to P4's weakness, advanced age and inability to manage on his own. A home health aide (HHA) was ordered one hour per week to assist with bathing and dressing. Homemaking was ordered for three hours per week to assist with light housekeeping duties. P4's medical record revealed he had two SNV's completed on 8/16/21 and 8/17/21, which did not indicate any safety concerns or poor home conditions. P4 had a discharge order dated 8/18/21, which indicated P4 would be discharged due to various safety concerns with staff and conditions of the home. P4's home safety evaluation dated 8/16/21, did not indicate any safety concerns or hazards. When interviewed on 2/9/22, at 11:00 a.m. P4 stated, he was told the home health agency did not have staff available and he was discharged two days after his admission. P4 could not recall which agency took over after he was discharged, nor when they took over. P4 stated the agency left it up to the Veteran's Administration (VA) to find a new agency. When interviewed on 2/9/22, at 11:20 a.m. P4's clinical manager (CM)-A stated, P4 was discharged from the agency because he had two other men living in his home, which made the HHA feel uncomfortable during her initial visit and the HHA was, "terrified." CM-A also stated, P4's living environment was cluttered, but not unsafe. CM-A stated, the agency did not make another visit to assess the safety of the HHA, nor did they attempt to find options so P4 would be able to receive the ordered care or assist with finding another agency that could provide the care. Instead the agency reported to the Veterans Administration they were discharging P4. CM-A stated once in the VA's hands, the agency would not do anything to ensure the patients needs were met. P1's recertification period 12/10/21 through 2/7/22, indicated his start of care date (SOC) was 8/12/21. P1's diagnoses included diabetes, and quadriplegia (paralysis of all four limbs). Skilled nurse visits (SNV) were ordered every other week for medication management, assess and monitor of his overall health, blood sugars, as well as supervision of the home health aide (HHA). HHA services were ordered one time per week to assist with range of motion (ROM) exercises, medication reminders, put on compression stockings, check blood pressure, temperature and blood sugar, bathing, toileting, grooming and positioning. P1's nurse visit documentation was reviewed November 24, 2021 through January 18, 2022. SNV were completed on 11/24/21, 12/8/21, 12/15/21, 12/22/21, and 1/5/22. -SNV 12/22/21, documented P1 was having increased weakness with transfers and it was becoming harder to transfer from chair to bed and bed to toilet. A transfer was observed by the nurse and the primary physician was aware and had placed an order for a physical therapy evaluation in the home to work with patient transferring. No other concerns were identified for P1 during the time period. The medical record lacked documentation of safety or behavior concerns, nor had any discharge planning been documented during any of the nursing visits. P1's HHA supervision visits and Aide Care Plan documentation was reviewed October 27,2021 through January 18, 2022. Instructions included to assist P1 to transfer with a pivot transfer and gait belt or the use of a mechanical lift. The documentation lacked any concerns with safety or inappropriate behaviors the HHA may need to be aware of. When interviewed on 2/7/22, at 2:04 p.m. P1 stated he had not had home care services for more than two weeks. His son helped with plowing the yard and some other tasks but was not able to assist him with bathing, toileting or personal care. His son had a traumatic brain injury and was not able to assist him with setting up his medications. When the agency discharged him and left his home on 1/19/22, they had left him with sheets and bedding on his bed that were soiled with urine and bowel movement, as he had an accident that morning. He had told the aide and nurse of his need for a bedding change, however, they left his home without performing this task. He had to cover the soiled bedding with towels until his son could come to change the bedding. P1 stated he was able to slide transfer from his wheelchair to the toilet but was unable to answer how he would be able to shower without assistance. He was trying to setup his medications but had spilled the pills out of the bottle onto the floor and was unable to pick them up or get early refills on the medications. The home care nurse had set pills up for him and he had a day or two of that setup remaining. P1 was not sure what he was going to do when he completed the previously setup medications. P1 indicated he had no warning the agency was going to discharge him prior to the day of the visit on 1/19/22. The agency staff had never mentioned to him they felt he was unsafe at home. He had told them they could use the mechanical lift to assist him with transfers but had been told it would require a two person transfer to do that. P1 had called the VA after the agency discharged him, but was told the VA could not get another home care agency for him. He had the benefits, but they just could not find another agency. He did not know what he was going to do about his medications. When interviewed on 2/8/22, at 9:17 a.m. clinical manager (CM)-A indicated the issues with P1 had started on 1/19/22. She had notified P1 the HHA would only be able to assist as a standby assist transfer going forward because of safety issues. CM-A stated P1 had gotten angry with this information. P1 started making derogatory comments and name calling at the HHA. This upset the aide, who then stated she could no longer work in the home and went outside. CM-A indicated P1 nor his son were able to setup P1's medications for daily medication administration as ordered by the physician. P1 continued to make derogatory statements, while CM-A was setting up his medications. CM-A told P1 he was making her uncomfortable and she would have to leave. She explained to P1 she had setup two and one half weeks of his medications and she hoped he could find another agency he would be happy with. She called the administrator and updated her on P1's behavior and was told the administrator had spoken with the veterans association clinic (VA) and was notified the agency could discharge P1. CM-A indicated she did not know the protocol to discharge clients, but thought the agency could have given him a 10 day notice, but the HHA would have refused to go into his home. There were other HHA's working for the agency but she did not know how it would work with changing the schedule. CM-A stated, if the VA indicated they would take over with P1, that would be sufficient. The agency had not attempted to find options for P1 so that he could receive the ordered care, had not attempted to find another agency, nor had provided P1 with any advanced notice of discharge. During joint interview on 2/8/22, at 10:17 a.m. with the administrator and CM-A, the administrator indicated they could not send another aide out to P1 as he lived an hour away and there was no one else that could go. She had called the VA and they had told her to do what the agency felt they had to do. CM-A stated they had thought the VA was taking care of P1 when they had notified them the agency had discharged him, otherwise they would have never left him, "high and dry." During telephone interview on 2/8/22, at 10:45 a.m. the director of nursing (DON)/owner stated the agency works through the VA and if there were any issues with patients, they would communicate with the nurse in charge of the patient's case. P1 was discharged because he would not allow the staff to apply a transfer belt with transfers, which made the transfers unsafe. The agency could have given P1 10 days notice prior to the discharge but they could not have sent any other staff in because of the unsafe situation. No referrals or other resource information was given to P1 because the VA handled making calls to other agency's. Their agency worked directly with the VA, who was responsible for P1's, "whole situation." P1's life was not in any danger because they had discharged services. The VA knew who was available, so they must have had something in mind. The agency did not provide lists of alternative resources to the agency VA patients. The VA did everything for them so the agency did not treat the VA patients the same way other patients were handled. P2's recertification period 9/3/21 through 11/1/21, indicated a SOC date of 5/6/21. Diagnoses included diabetes, radiculopathy (compression of a nerve in the lower back that causes numbness, weakness and pain), hypertension, and lumbago. SNV were ordered every other week to assess and manage P2's many co-morbidities, including his cervical spine surgery. P2 was struggling to manage health conditions. HHA was ordered one hour per week to assist with bathing and dressing. P2's nurse visit documentation was reviewed May 1, 2021 through September 30, 2021. SNV were completed 8/3/21, 8/17,121, 8/24/21, 8/30/21, 9/13/21, and 9/27/21. No further SNV were completed after the visit on 9/27/21. The visit notes lacked documentation regarding any noted concerns, inappropriate behaviors or discharge planning. P2's HHA supervision visits and Aide Care Plan documentation was reviewed and lacked any documentation of concerns or inappropriate behaviors to be aware of. Physician Plan of Care Updates were reviewed May 1, 2021 through October 5, 2021 and revealed the following: -August 24, 2021, notified the primary physician P2 had made comments of hating women, inappropriate sexual innuendos and comments regarding being a CIA assassin and torturing people. P2's comments were making staff uncomfortable. A call had been placed to P2's VA case manager to discuss discharging P2. -September 29, 2021, notified the primary physician of misunderstanding P2 had been discharged. A previous note, 8/24/21, had indicated discharge planning was being discussed, however, patient was not discharged due to he was reassigned to a male nurse and the problem was resolved. -October 5, 2021, notified the primary physician P2 had been discharged from the agency due to the VA physician had indicated he no longer needed home care. Last SNV occurred on 9/27/21. The physician replied with a hand written comment indicating the notification was not accurate. The agency would need to alert the VA if services were still necessary. What does this mean the physician replied to whom? A notation handwritten by registered nurse (RN)-A on P2's visit note, 8/30/21, dated 10/5/21, indicated P2 was discharged due to the visits were unbillable due to physician refused to extend home care services. The medical record lacked documentation of 10 day notice, list of resources or notification to P2 of the agency's discharge. During interview on 2/9/22, at 9:17 a.m. HHA-B stated she had cared for P2 in his home. She had never felt threatened by him, but he could be happy one minute and then not in the next minute. He had never frightened her and she had never had any issues providing his care. He would make sexual innuendos to her that would make her uncomfortable but she would just brush them off. During interview on 2/7/22, at 4:18 p.m. the administrator stated the agency had not given P2 a 10 day notice as he had been, "another trouble patient." P2 had made sexual comments to the HHA and the CM-A had also become uncomfortable with him. They switched him to a male nurse, but there was a misunderstanding and the VA thought he had been discharged. He would need to get another referral done. He did do that and then called the agency but was not readmitted. He used to be, "an assassin," and that frightened the staff. please clarify this When interviewed on 2/9/22, at 12:11 p.m. RN-A stated he discharged P2 because the physician had said he no longer required home care services. There was some confusion, CM-A had sent an update note that the VA had interpreted as the agency was discharging P2 and the VA stopped home care services, which the agency was not made aware of. The administrator told RN-A on 10/5/21, P2 no longer needed services and to send the physician an order the agency was discharging him. During a telephone interview on 2/8/22, at 10:45 a.m. the DON/owner indicated P2 was another patient the agency had communicated with VA about. P2 had given the staff, "hidden threats," so they had set him up with a male nurse. The agency did not give P2 a 10 day notice or other resources because the VA was managing his care. When interviewed on 2/9/22, at 9:00 a.m. RN-C from VA clinic primary care indicated, if a home care agency was going to discharge a patient the expectation would be to give the patient notice, notify the primary care physician and to file a vulnerable adult report. The VA would then generally generate another referral to other home care agencies in the area for home care. When interviewed on 2/9/22, at 9:48 a.m. RN-B from VA HHA referral offices stated for any patients being discharged from a home care agency, the expectation was the agency was to update the VA primary care team and file a vulnerable adult report if it was needed. The VA would never tell an agency if it was ok or not ok to discharge. The VA was, "just a purchasing services from an outside vendor," they did not provide the services. The agency's policy Transfer, Discharge or Terminate From Service, dated June 2020, indicated at determination to discharge a client for cause the agency would advise the client or client representative, the physician that a discharge for cause was being considered, make efforts to resolve the problem(s) presented by the client's behavior, provide the client with contact information for other agencies or providers who may be able to provide care and document the problem(s) and efforts made to resolve the problem(s) in the client's clinical record. If the agency terminates a service plan with a client and the client continues to need home care services, the agency shall provide the client with a list of agencies in the area.

Document complaint and resolution CFR(s): 484.50(e)(1)(ii) (ii) Document both the existence of the complaint and the resolution of the complaint; and This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to document any of the complaints the agency received, the investigation of complaints received or the resolution of the complaints received. The agency practice had the potential to affect all 32 patients currently served by the agency. Review of the agency's Grievance Log revealed no grievances had been reported 2012, 2013, 2014, 2016, 2017, 2018, 2019, 2020, and 2021. Two grievances were documented in 2015 from patient's and showed investigation results and date the patient had been notified. During interview on 2/9/22, at 9:50 a.m. the administrator stated patients would call and complain about a worker, they did not do something or, "things like that." The administrator would talk with the worker, but did not keep a complaint log on those type of complaints. When interviewed on 2/9/22, at 11:47 a.m. the clinical manager (CM)-A stated, if complaints came in they were, "probably just phoned in and the administrator would handle them." CM-A recalled one time the administrator had told her a patient had a complaint and, "I talked to the patient about it, but I never thought to write it down. I can not remember what the complaint was in regards to." The agency policy entitled, Clients Complaints and Grievances dated October 2020, indicated clients may voice concerns and grievances regarding any aspect of care or service. Staff members may receive a complaint or grievance. Staff members report complaints or grievances to the administrator or designee. A complaint must be in writing, containing name and address of the person filing it and state the alleged problem or action and the remedy or relief sought. The administrator would document and investigate the complaint within 10 days. The complaint or grievance would be documented with action taken and resolution on the client complaint log or report.

Immediate reporting of abuse by all staff CFR(s): 484.50(e)(2) Any HHA staff (whether employed directly or under arrangements) in the normal course of providing services to patients, who identifies, notices, or recognizes incidences or circumstances of mistreatment, neglect, verbal, mental, sexual, and/or physical abuse, including injuries of unknown source, or misappropriation of patient property, must report these findings immediately to the HHA and other appropriate authorities in accordance with state law. This ELEMENT is not met as evidenced by: Based on interview and document review, the agency failed to immediately report to the State Agency (SA), an allegation of neglect for 1 of 8 patients (P1) when the agency discharged P1 without notice or resources and who lived alone and needed assistance with bathing and medication set up. Further, the agency failed to train staff on identification and timely reporting of abuse, neglect, misappropriation of property or injury of unknown origin. This had the potential to affect all 32 patients who received services with the home care agency. P1's recertification period 12/10/21 through 2/7/22, indicated his start of care date (SOC) was 8/12/21. P1's diagnoses included diabetes, and quadriplegia (paralysis of all four limbs). Skilled nurse visits (SNV) were ordered every other week for medication management, assess and monitor of his overall health, blood sugars, as well as supervision of the home health aide (HHA). HHA services were ordered one time per week to assist with range of motion (ROM) exercises, medication reminders, put on compression stockings, check blood pressure, temperature and blood sugar, bathing, toileting, grooming and positioning. P1's nurse visit documentation was reviewed and revealed the following: -SNV dated 1/19/22, indicated patient was angry with home care staff after being told staff would no longer be able to assist him with transferring and would provide stand by assist only. P1 began to name call and make derogatory comments to staff. The HHA left the home before providing cares and indicated she would not return. The nurse continued her visit with med set up but became uncomfortable with the name calling and angry comments. The nurse notified P1 she had setup two and one-half weeks of medications and she would be discharging him. The nurse notified the veterans administration clinic (VA) of the patient's discharge. No further follow up was documented. When interviewed on 2/7/22, at 2:04 p.m. P1 stated, he had not had home care services for more than two weeks. P1 stated, he was almost out of medications the nurse had set up for him from the home care agency. He tried to set them up himself, but had spilled some pills on the floor and was unable to pick them up. He then tried to order more medications to replace the ones that spilled on the floor, but it was too early to get them filled. P1 stated he did not know how he would be able to get his medications. In addition, on 1/19/22, the nurse and HHA had left his home without changing his bedding and his bed had been soiled with urine and stool, he was unable to change his bedding himself and had to pile towels over the soiled sheets. P1 stated, he was able to get on and off the toilet himself, but was not able to shower or bathe himself. P1 stated, the agency had not given him any notice and he has called the VA clinic to see if he can get help as he has VA benefits, but so far they have not been able to find anyone to care for him. When interviewed on 2/8/22, at 9:17 a.m. clinical manager (CM)-A stated on 1/19/22, P1 had become upset after being told the HHA was unable to transfer him anymore for safety issues. P1 had started calling the HHA names and made, "derogatory," remarks to the HHA and CM-A. The aide left the home without providing cares and did not change the soiled bedding. CM-A set up 2 1/2 weeks of P1's medications and then told P1 he was being discharged and left the home without providing the personal cares and without changing the bedding. CM-A stated P1 was reliant on the agency staff to set up medications and assist with bathing and P1 was not capable of doing this on his own. CM-A stated, there were no other HHA's that would be able to do the visits. CM-A stated she felt P1 was a vulnerable adult, but did not think a vulnerable adult report needed to be filed, even though the agency stopped providing the needed care because the VA would, "take over." CM-A stated she had never received training on filing a vulnerable adult report or how to report concerns of neglect or abuse to the state agency. CM-A would have reported the sudden discharge to the administrator. During joint interview on 2/8/22, at 10:17 a.m. with the administrator and CM-A, the administrator indicated they could not send another aide out to P1 as he lived an hour away and there was no one else that could go. She had called the VA and they had told her, "to do what the agency felt they had to do." CM-A stated, they had thought the VA was taking care of P1 when they had notified them the agency had discharged him, otherwise they would have never left him without services. When interviewed on 2/9/22, at 12:11 p.m. registered nurse (RN)-A stated, he did not know what a vulnerable adult report was. He had never received any training of when and how a vulnerable adult was filed or how to report concerns to the state agency. RN-A stated, if he had concerns for a patient, he would notify the physician and VA. He did not file a vulnerable adult report for P1 because he was, "not aware of anything like that." During telephone interview on 2/8/22, at 10:45 a.m. the director of nursing (DON)/owner stated the agency works through the VA and if there were any issues with patients, they would communicate with the nurse in charge of the patient's case. P1 was discharged because he would not allow the staff to apply a transfer belt with transfers, which made the transfers unsafe. The agency could have given P1 10 days notice prior to the discharge but they could not have sent any other staff in because of the unsafe situation. No referrals or other resource information was given to P1 because the VA handled making calls to other agency's. Their agency worked directly with the VA, who was responsible for P1's, "whole situation." P1's life was not in any danger because they had discharged services, even though he was unable to set up his own medications or take a bath or a shower. The DON stated the VA knew who was available, so, "they must have had something in mind." Their agency did not provide lists of alternative resources to the agency's VA patients. The VA did everything for them so the agency did not treat the VA patients the same way other patients were handled. The staff were to file a vulnerable adult report if they suspected a patient was abused or neglected, but generally they try to involve the family to get the situation resolved. If it was a situation the staff could not do anything, they would call the ambulance, "but this was not a situation like that." The DON stated just because he was not getting his bath or house cleaned was not a reason to file a vulnerable adult report and he had an extra week of medications setup. On 2/8/22, at 4:08 p.m. the administrator indicated the nurses were to call the 800 reporting number for vulnerable adult reports. The nurses did a vulnerable adult assessment quarterly. She, herself, would never call the 800 number as she was not a nurse and did not go into patient homes. On 2/9/22, at 9:00 a.m. RN-B from the VA primary care clinic stated, if an agency was going to discharge a patient, the expectation would be to notify the primary physician and file a vulnerable adult report if it was appropriate, such as the patient was unable to set up his medications, or bathe. The agency's Abuse, Neglect or Exploitation Reporting and Prevention policy dated February 2021, indicated the agency would immediately report abuse, neglect, or misappropriation of property to the adult protective services division and the Minnesota Department of Health immediately. Neglect was defined as failure to provide for one's self the goods or services including medical services, which are necessary to avoid physical or emotional harm or pain or the failure of a caretaker to provide such goods or services. The agency would report incidents utilizing the incident report form consistent with the requirements of the incident management system guide and state regulations. The agency would ensure the reporter with the most direct knowledge of the incident prepared the incident report form. The agency would maintain the immediate response to all reported allegations of incidents involving abuse, neglect, misappropriation of property, injuries of unknown sources and deaths, as applicable. The agency would provide all it's employees with training on incident policies and procedures for identification , and timely reporting of abuse, neglect, misappropriation of property.

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: Based on interview and document review, the home health agency (HHA) failed to meet the Condition of Participation at 484.70, Infection Prevention and Control. The agency only had a staff vaccination rate of 50%. The HHA failed to have any policies and procedures in place to ensure all staff were fully vaccinated against COVID-19, failed to have processes for staff to request and exemption, and failed to have additional precautions to mitigate the risk for transmission of COVID-19 for staff who were unvaccinated. The agency failed to consistently implement infection control practices related to COVID-19 requirements including employee and resident symptom screening, provision of appropriate PPE, and failed to notify patients of a potential exposure to COVID-19 or monitor, assess and test the patients following their exposure to agency staff who tested positive for COVID-19 and had provided their care. Further the agency failed to maintain and document an infection control program. The agency failed to have a system for infection surveillance, identifying infections or risk of infection in their patients or staff and failed to provide infection control training to their employees. These combined failures resulted in Condition level noncompliance as well as immediate jeopardy at G684, and G687. See G682: Based on observation, interview and document review, the agency failed to implement appropriate infection control practices related to COVID-19 in relation to conducting health screenings for Healthcare Workers (HCW's) and patients prior to visits. In addition, the agency failed to ensure all HCW's were provided with and used proper Personal Protective Equipment (PPE) based on the current Federal and State government guidelines related to COVID-19. This had the potential to affect all 32 patients currently served by the agency. See G684: Based on interview and record review, the agency failed to develop and implement an infection control program. The agency failed to develop and implement any system for infection surveillance, identifying infections, including COVID-19 or risk of infection in their patients or staff and failed to implement and document infection control training for the agency staff, resulting in risk of potential serious harm or death to all 32 current patients. This resulted in an immediate jeopardy (IJ) situation as this system failure had the potential to cause serious harm or death to their patients, patient families, care givers and agency staff. See G687: Based on interview and document review, the agency failed to develop policies and procedures to ensure all staff were vaccinated for COVID-19, failed to develop a process to track and document staff vaccination status, failed to develop a process by which staff may request an exemption for COVID-19 vaccination requirements, and failed to develop contingency plans for staff who were not fully vaccinated, resulting in a risk of potential serious harm or death to all 32 current patients. This resulted in an immediate jeopardy (IJ) situation as this system failure had the potential to cause serious harm or death to their patients, patient families, care givers and agency staff.

Infection Prevention CFR(s): 484.70(a) Standard: Infection Prevention. The HHA must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases. This STANDARD is not met as evidenced by: Based on observation, interview and document review, the agency failed to implement appropriate infection control practices related to COVID-19 in relation to conducting health screenings for Healthcare Workers (HCW's) and patients prior to visits. In addition, the agency failed to ensure all HCW's were provided with and used proper Personal Protective Equipment (PPE) based on the current Federal and State government guidelines related to COVID-19. This had the potential to affect all 32 patients currently served by the agency. During observations of HCW's in the agency office on 2/7/22, 2/8/22, 2/9/22 and 2/10/22, unvaccinated home health aide (HHA)-B was observed in close proximity of less than three feet with unvaccinated case manager (CM)-A and unvaccinated administrator while performing various office duties through out the course of four days. The unvaccinated staff members were not observed to wear any PPE such as masks during multiple observations throughout the survey. On 2/10/22, HHA-A was observed cleaning the office and obtaining supplies. HHA-A was not wearing a face mask or any other PPE in the course of her duties and was not vaccinated. HHA-A was observed in close proximity of less than three feet with the unvaccinated administrator and HHA-B for over 15 minutes. During interview on 2/10/22, at 9:46 a.m. HHA -A stated the aides do not call patients to screen them before their visits. She did not have their phone numbers handy with her but thought she could find them on their aide sheets. She had never asked clients if they were sick or had an exposure to COVID-19 before she entered the patient's homes. When she was in the home she checked patients temperatures and then she would ask them about falls or how they were feeling. When interviewed on 2/10/22, at 10:29 a.m. HHA-B stated she did not screen patients prior to her visits. She would never call them because she did not want to have to use her personal phone to do so. She did not want patients to obtain her personal number by calling them. During telephone interview on 2/9/22, at 12:11 p.m. registered nurse (RN)-A stated he was unvaccinated. RN-A indicated he wore gloves and a surgical face mask while providing patient care, however, he did not wear eye protection. When interviewed on 2/8/22, at 9:17 a.m. CM-A stated she did not think all the staff wore face shields or glasses but some did. The staff all wore surgical masks with patient care whether the patient was vaccinated or not. The staff also practiced hand washing, using hand sanitizer and wearing gloves when working with patients. She wore a face mask and gloves with patient care. She did not wear eye protection because she wore her prescription eye glasses at all times. CM-A verified she was not vaccinated for COVID-19. CM-A stated there was no requirement for staff to screen themselves for signs of COVID-19 before entering a patient home and no requirement to screen the patients for signs of COVID-19 before entering the home. There also was no requirement to wear face mask and eye protection during the COVID-19 pandemic. During joint telephone interview with the director of nursing (DON)/owner and the administrator on 2/8/22, at 10:45 a.m. the director of nursing (DON)/owner indicated unvaccinated staff needed to be masked with N95 masks and wear gloves with patient care. The agency had plastic shields available for eye protection. The administrator stated the agency did have N95 masks on order but did not currently have any available for staff use. Staff were currently to wear surgical masks and eye protection with all patient care. They did not know how this requirement was communicated with the staff. The agency's policy COVID-19 Infection Control and Prevention dated May 2021, included, staff would be trained in using PPE which would include when to use and what PPE was necessary. Staff would need to wear either an N95 respirator, or a well fitting face mask, eye protection and clean, non-sterile gloves on entry into the client's home. The policy did not address screening for symptoms of COVID-19.

Infection control CFR(s): 484.70(b)(1)(2) Standard: Control. The HHA must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA's quality assessment and performance improvement (QAPI) program. The infection control program must include: (1) A method for identifying infectious and communicable disease problems; and (2) A plan for the appropriate actions that are expected to result in improvement and disease prevention. This STANDARD is not met as evidenced by: Based on interview and record review, the agency failed to develop and implement an infection control program. The agency failed to develop and implement any system for infection surveillance, identifying infections, including COVID-19 or risk of infection in their patients or staff and failed to implement and document infection control training for the agency staff, resulting in risk of potential serious harm or death to all 32 current patients. This resulted in an immediate jeopardy (IJ) situation as this system failure had the potential to cause serious harm or death to their patients, patient families, care givers and agency staff. The immediate jeopardy began on 1/30/22, when the agency failed to track, monitor and inform patients of potential exposure from a staff who tested positive for COVID-19 on 1/30/22 and had provided direct care to several patients on 1/28/22. The director of nursing (DON)/owner and administrator were notified of the immediate jeopardy at 1:00 p.m. on 2/10/22. The immediate jeopardy was removed on 2/23/22, when the agency developed and implemented policies and procedures to track staff and patient illnesses, report applicable illness to the appropriate officials, develop quarantine and return to work policies as recommended by the CDC and monitor and enforce the agency’s personal protective equipment (PPE) policies with all staff. When interviewed on 2/9/22, at 9:50 a.m. the administrator indicated the agency had a policy for infection control, however they did not have an infection control program. The agency did not have anyone delegated to track staff illness. If staff were sick they would call in and if they were ill for three or more days they would need a doctor note to return to work. The agency did not document sick calls from employees. Nurses were to manage patient illness and antibiotic use. P5 had tested positive for COVID-19 on 2/4/22, and HHA-B had assisted P5 with bathing and grooming in the morning of 2/4/22. HHA-B was not vaccinated for COVID-19 and had provided prolonged, personal care to P5. The exposed, unvaccinated HHA was not tested for COVID-19 following her high risk exposure and continued to provide care for other agency patients. HHA-A, who was unvaccinated, tested positive for COVID-19 on 1/30/22, after experiencing symptoms of fever and sore throat. HHA-A provided direct personal care to P6, P7 and P8 on 1/28/22. The agency did not inform P6, P7, or P8 of the exposure and failed to monitor the patients for signs and symptoms of COVID-19 following their high risk exposure. When interviewed on 2/8/22, at 9:17 a.m. clinical manager (CM)-A stated she did not think all the staff wore a face shield or eye protection while providing assistance with personal care. She had her prescription glasses, which she always wore. When interviewed on 2/9/22, at 12:11 p.m. registered nurse (RN)-A stated he did not wear eye protection while providing patient care in the home. During joint interview on 2/9/22, at 12:14 p.m. with CM-A and the administrator, CM-A indicated the agency was working on getting a form together to track employee and patient illness's. CM-A stated she was in charge of providing staff education. She orientated the new employees as well as any home health aides who needed to orientate to a new skill, she would educate them and check them off. She had educated the staff on COVID-19 guidance when it was needed, however could not provide documentation of infection control education or satisfactory completion. CM-A stated they did not formally track staff or patient illness but the agency was small and if someone came down with COVID-19 they were all aware of it. Patient's testing positive for COVID-19 would have that documented in their chart but was not documented anywhere else. During telephone interview on 2/8/22, at 10:45 a.m. the director of nursing (DON)/owner stated there were so few staff that if anyone did not feel well they would call in and they would all be aware of it. The agency was looking at formalizing the procedure. The agency's policy Infection Prevention and Control dated January 2021, indicated the agency would maintain a coordinated agency wide program for the surveillance, identification, prevention, control and investigation of infectious and communicable diseases through its quality assessment and performance improvement program (QAPI). The intent of the infection/exposure control plan was to give direction to staff in the care they provide in relation to infection control practices, educate staff, clients and others in the prevention and control of infections, provide for surveillance systems to track the occurrence and transmission of infections, ensure compliance, and require documentation of infections that were acquired while patients were receiving services from the agency. The agency would comply with all applicable state and federal regulations. The DON was responsible for leading the infection prevention and control team and assign other RN's to assist. All staff would be educated on infection control policies and procedures. Staff were to be provided training on the basics of infection control. Infection control in-services would be scheduled no less than annually and attendance would be mandatory and would be documented. Infection control data would be collected, analyzed and trended. The immediate jeopardy that began on 1/30/22, was removed and the deficient practice corrected on 2/23/22, when the facility developed and implemented policies and procedures to track staff and patient illnesses, report applicable illness to the appropriate officials, develop quarantine and return to work policies as recommended by the Centers for Disease Control (CDC) and monitor and enforce the agency's PPE policies with all 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: Based on interview and document review, the agency failed to develop policies and procedures to ensure all staff were vaccinated for COVID-19, failed to develop a process to track and document staff vaccination status, failed to develop a process by which staff may request an exemption for COVID-19 vaccination requirements, and failed to develop contingency plans for staff who were not fully vaccinated, resulting in a risk of potential serious harm or death to all 32 current patients. This resulted in an immediate jeopardy (IJ) situation as this system failure had the potential to cause serious harm or death to their patients, patient families, care givers and agency staff. The immediate jeopardy began on 1/27/22, when the agency failed to develop policies and procedures to ensure all staff were vaccinated for COVID-19, failed to develop a process to track and document staff vaccination status, failed to develop a process by which staff may request an exemption for COVID-19 vaccination requirements, and failed to develop a contingency plan for staff who were not fully vaccinated and was identified on 2/8/22, at 4:14 p.m. The director of nursing (DON)/owner and administrator were notified of the immediate jeopardy at 4:14 p.m. on 2/8/22. The immediate jeopardy was removed on 2/23/22, when the agency developed and implemented policies and procedures to address tracking and documentation of the agency's staff vaccination status, developed a contingency plan which included a deadline for unvaccinated staff to have received their first dose of a COVID-19 vaccine and implemented additional precautions to mitigate the spread of COVID-19 by unvaccinated staff. Crow Wing county community level for transmission of COVID-19 was recorded as high. The agency staff vaccination rate was currently at 50 percent of staff who remained unvaccinated. Review of the agency employee list for COVID-19 indicated the agency employed 22 employees. Eleven employees were marked as having had at least one dose of the COVID-19 vaccination, however, lacked any proof of vaccination status. The remaining eleven employees were listed as unvaccinated and did not indicate if an exemption was submitted or approved. When interviewed on 2/8/22, at 9:17 a.m. clinical manager (CM)-A stated staff were required to be vaccinated by March 15, 2022, and she had just filled out an exemption form but still needed to get the form notarized. She was unsure what the process was for staff to have exemptions to the COVID-19 vaccines and she thought the state would be reviewing the exemption forms and approving them. The administrative staff had a meeting three weeks ago with the director of nursing (DON)/owner and they were told the staff would have an opportunity to obtain the COVID-19 vaccine or fill out an exemption form, however, they were never given an exemption form or instructed on the process. The DON would be in charge of the staff vaccinations. During interview on 2/8/22, at 10:17 a.m. the administrator stated she was having the staff fill out exemption forms and would be holding on to them until they knew what the changes were regarding staff vaccination requirements. The administrator indicated she thought the date for staff vaccinations had been moved to March 2022, for all health care workers. Right now the agency was just collecting the information from staff and then would try to figure out what the agency was going to do. The agency did not provide their employees with any information regarding the COVID-19 vaccines or the risk and benefits of the vaccine. They did not have a process for tracking vaccinations or submitting exemptions for COVID-19 and were waiting for the DON to provide them with further direction. On 2/8/22, at 10:45 a.m. the director of nursing (DON)/owner indicated the agency was waiting for the government to decide what was going to be required for healthcare workers (HCW) vaccination for COVID-19. The agency had just completed an informal survey of their staff to see who was vaccinated and who would not be willing to obtain the COVID-19 vaccination. They had not gone any further with staff vaccinations because she did not think it was being enforced yet. She was not aware of how many of the agency staff were unvaccinated, but had warned the staff exemptions or vaccine would be required by March 2022. The agency had not requested record of staff vaccinations. The DON indicated she was not aware of the new guidance the Centers for Medicare and Medicaid Services (CMS) had released on 12/28/21 regarding the Interim Final Rule for COVID-19 Health Care Staff Vaccination. The agency's policy COVID-19 Infection Control and Prevention, dated May 2021, indicated fully vaccinated staff with exposure to COVID-19 and were asymptomatic would not need to be restricted from work, unless they have traveled. Fully vaccinated staff may be exempt from expanded screening testing, unless symptomatic. The agency's policy did not address any procedures or policy for unvaccinated staff. The immediate jeopardy that began on 1/27/22, was removed on 2/23/22, when the agency developed and implemented policies and procedures to address tracking and documentation of the agency's staff vaccination status, developed a contingency plan which included a deadline for unvaccinated staff to have received their first dose of a CIVID-19 vaccine and implemented additional precautions to mitigate the spread of COVID-19 by unvaccinated staff.

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 interview and document review, the home health agency (HHA) failed to document discharge information and send to the patient's primary physician for 3 of 8 patients (P1, P2, and P4) whose records were reviewed. P4's recertification period 8/16/21 through 10/14/21, indicated a SOC date of 8/16/21. Diagnoses included acute myocardial infarction, aortocoronary bypass graft and pacemaker placement. SNV was ordered every other week to assess and manage P4's co-morbidities, including setting up extensive amount of medications due to P4's weakness, advanced age and inability to manage on his own . HHA was ordered one hour per week to assist with bathing and dressing. Homemaking was ordered for three hours per week to assist with light housekeeping duties. Review of P4's medical record revealed he had two SNV's completed on 8/16/21 and 8/17/21 which did not indicate any safety concerns or poor home conditions. Home safety evaluation dated 8/16/21 did not indicate any safety concerns or hazards. Further review revealed a discharge order dated 8/18/21 which indicated P4 would be discharged due to various safety concerns with staff and conditions of the home. The medical record lacked a completed discharge summary. During an interview with P4 on 2/9/22, at 11:00 a.m. he stated he was told they did not have staff available and he was discharged two days after his admission. P4 could not recall which agency took over after he was discharged, nor when they took over. P4 stated the agency left it up to the Veteran's Administration (VA) to find a new agency. When interviewed on 2/9/22, at 11:20 a.m. CM-A stated she hasn't had any clients that discharge to themsleves. She stated the discharges usually end up bad or the client ends up dying. CM-A stated she hasn't written up any discharge summaries She stated it was P4's choice to live there and she had reported it to the VA. CM-A stated once it was in the VA's hands, the agency does nothing further to ensure P4's needs were met. P1's recertification period 12/10/21 through 2/7/22, indicated his start of care date (SOC) was 8/12/21. P1's diagnoses included diabetes, and quadriplegia (paralysis of all four limbs). Skilled nurse visits (SNV) were ordered every other week for medication management, assess and monitor of his overall health, blood sugars, as well as supervision of the home health aide (HHA). HHA services were ordered one time per week to assist with range of motion (ROM) exercises, medication reminders, put on compression stockings, check blood pressure, temperature and blood sugar, bathing, toileting, grooming and positioning. P1's nurse visit documentation was reviewed November 24, 2021 through January 18, 2022. SNV were completed on 11/24/21, 12/8/21, 12/15/21, 12/22/21, and 1/5/22. The SNV 12/22/21, documented P1 was having increased weakness with transfers and it was becoming harder to transfer from chair to bed and bed to toilet. A transfer was observed by the nurse and the primary physician was aware and had placed an order for a physical therapy evaluation in the home to work with patient transferring. No other concerns were identified for P1 during the time period. The medical record lacked documentation of safety or behavior concerns, nor had any discharge planning been documented during any of the nursing visits. During interview on 2/7/22, at 2:04 p.m. P1 stated he had not had home care services for more than two weeks. His nurse and home health aide (HHA) had visited him on 1/19/22, and after they left he received a phone call from the agency administrator that he was being discharged. He had received no prior warning of the discharge or resources for other agencies. The nurse and aide had just left that day and never returned. When interviewed on 2/8/22, at 9:17 a.m. case manager (CM)-A stated she had discharged P1 because of the abusive comments he was making toward the HHA and herself. She was not sure what the procedure would be for discharge of patients. She had called the veterans administration clinic (VA) and informed them verbally of the discharge and had felt that was all that would be needed. P2's recertification period 9/3/21 through 11/1/21, indicated a SOC date of 5/6/21. Diagnoses included diabetes, radiculopathy (compression of a nerve in the lower back that causes numbness, weakness and pain), hypertension, and lumbago. SNV were ordered every other week to assess and manage P2's many co-morbidities, including his cervical spine surgery. P2 was struggling to manage health conditions. HHA was ordered one hour per week to assist with bathing and dressing. P2's nurse visit documentation was reviewed May 1, 2021 through September 30, 2021. SNV were completed 8/3/21, 8/17/21, 8/24/21, 8/30/21, 9/13/21, and 9/27/21. No further SNV were completed after the visit on 9/27/21. The visit notes lacked documentation regarding any noted concerns, inappropriate behaviors or discharge planning. P2's HHA supervision visits and Aide Care Plan documentation was reviewed and lacked any documentation of concerns or inappropriate behaviors to be aware of. During interview on 2/9/22, at 12:11 p.m. registered nurse (RN)-A stated the administrator had told me to send the physician an order to discharge P2 as he no longer needed services. I have never completed a discharge summary, that may be something CM-A or the administrator does. I have only just done the discharge order to the physician. When interviewed on 2/9/22, at 9:50 a.m. the administrator indicated the agency sent an order to notify the physician that a patient was being discharged. The majority of the agency patients were VA patients and the VA supplied the medical background with the referral. The agency did not do a discharge summary. All the information would be in the patient's care plan. The agency's policy Transfer, Discharge or Terminate from Service, dated June 2020, indicated a complete discharge summary would be completed within five business days of a patient's discharge. The discharge summary would include the patient's health status at discharge and a summary of activities for each discipline, which served the patient.